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From Farm to Fork — How Safe Is Our Food?


Food safety cartoonThe very food that we need to help us grow and live, could also cause us to become ill and die.   Food — we cannot live without it, but it can pose great danger.   Let’s look at cold hard reality.  Our food supply, our food storage systems and our cooking and eating habits may be responsible for a great deal of misery.  The Centers for Disease Control (CDC) estimates that contaminated food sickens approximately 76 million Americans, leading to some 325,000 hospitalizations and 5,000 deaths in the U.S. each year.

Food safety is particularly important to anyone with a take proactive measurescompromised immune system because we just don’t have the ability to fight infections whether they are bacterial or viral.  Certainly people who have had organ transplants fall into that category.  Transplant recipients must be especially careful.

As I started to research this posting the first question that popped into my mind was, “Which foods are most likely to make me sick. I found this list of the top ten from the Center for Science in the Public Interest as reprinted in the Fiscal Times

1) Leafy Greensleafy greens

Lettuce and spinach may be on the top of most nutritionists’ lists, but they’re also among the foods most linked to outbreaks of illness. The contaminations often starts at the farm through contact with wild animals or manure.

*Source: The Center for Science in the Public Interest

– See more at: http://www.thefiscaltimes.com/Media/Slideshow/2013/12/02/10-Foods-Most-Likely-Make-You-Sick#sthash.CTYjKR8I.dpuf

2) Eggs

The risk for salmonella makes eggs the second-most popular source of food-based illnesses. Consumers can protect themselves by fully cooking all eggs and eating or storing eggs promptly after cooking.

3) Tuna

tunaIf not properly stored immediately after being caught, tuna begins to decay and can release scrombotoxin, which can cause food poisoning.

4) Oysters

Raw or undercooked oysters can breed vibrio bacteria, which can cause mild food poisoning in healthy individuals and life-threatening illness among those with a weakened immune system. Best practices in preparing oysters is to discard any open shells before cooking, and any shells that didn’t open while cooking.

5) Potatoes

Baked potatoes become breeding grounds for botulism when they’re wrapped in foil and left out to cool too long. Unwrap potatoes after baking them, and store them in a cool, dark place before cooking.

6) Cheesecheese

Sticking with pasteurized cheese greatly reduces the risk of bacteria, but some soft cheeses—even those made with pasteurized cheese—are vulnerable to contamination during the cheese-making process.

7) Ice Cream

Everyone may scream for this summer treat, but when it’s made with undercooked eggs the cold stuff can become dangerous. Even store-bought ice cream can breed bacteria when it’s put back in the freezer after unfreezing.

8) Tomatoes

Salmonella can contaminate tomatoes on the farm via the roots, flowers or cracks in the skin. If an infected tomato is eaten raw, it has a high risk of infecting the person who consumers it.

9) Sprouts

utsThe humid settings ideal for cultivating sprouts are also model conditions for salmonella, listeria and E. Coli. The U.S. Department of Health and Human Services recommends that children, the elderly, pregnant women, and those with a weakened immune systems should avoid eating sprouts all together.

10) Berries

Strawberries, blackberries, and blueberries have been linked to a number of food-borne illness outbreaks in recent year. Last summer, a hepatitis A outbreak the sickened 150 people was traced back to frozen organic berries.

The Importance of Temperature

thermometerInadequate food temperature control is the most common factor contributing to food borne illness. Disease causing bacteria grow particularly well in foods high in protein such as meats, poultry, seafood, eggs, dairy products, cooked vegetables such as beans, and cooked cereal grains such as rice. Because of the high potential for rapid bacterial growth in these foods they are known as “potentially hazardous foods.”

Temperature Danger Zone

The temperature range at which bacteria grow best in potentially hazardous foods is between 41F. and 140F. The goal of all temperature controls is to either keep foods entirely out of this “danger zone” or to pass foods through this “danger zone” as quickly as possible.

So now you know which foods may pose the greatest threat to your health, but there are other factors that should concern us as well.  For example:

America’s food safety system has not been fundamentally modernized in more than 100 years.

Twenty states and D.C. did not meet or exceed the national average rate for being able to identify the pathogens responsible for foodborne disease outbreaks in their states.

Ensuring the public can quickly and safely receive medications during a major health emergency is one of the most serious challenges facing public health officials.  Sixteen states have purchased less than half of their share of federally-subsidized antivirals to use during a pandemic flu outbreak.

The main culprits are familiar. They include:

  • lmonellaSalmonella, bacteria that cause over 1.5 million illnesses per year. These commonly reside in uncooked poultry and eggs. Recent outbreaks have been linked to peanut butter, alfalfa sprouts and tomatoes.
  • E. coli 0157:H7, a dangerous bacterial strain that can cause kidney failure, turns up disproportionately in ground beef. Lately it’s been linked to spinach and pre-made cookie dough. (For a complete list, see the full report, which details also the geographical distribution of food-borne illnesses in the U.S.) You can read and learn more here http://tinyurl.com/k64har2

There are three types of hazards in a food manufacturing process: physical, chemical and biological. Foreign objects are the most obvious evidence of a contaminated product and are therefore most likely to be reported by production or by consumer complaints. However, they are also less likely than chemical or biological contaminants to affect large numbers of people.

Attributing illness to foods is a challenge for several reasons.  There are thousands of different foods, and we eat many varieties prepared in different ways, even in a single meal.  For the vast majority of foodborne illnesses, we simply don’t know which food is responsible for an illness.

One way to develop a fairly accurate estimate is to use  data collected during investigations of a food illness outbreak.   These investigations provide direct links between foodborne illnesses and which foods are responsible for them.

According to the National Institute of Allergies and Infectious Diseases, there are more than 250 known foodborne diseases. They can be caused by bacteria, viruses, or parasites. Natural and manufactured chemicals in food products also can make people sick. Some diseases are caused by toxins or poisons from the disease-causing microbe or germ, others are caused by your body’s reaction to the germ.

foodborne diseaseTypes of Foodborne Diseases as supplied by the National Institutes of Health (click on each one for details including symptoms and treatment or click this link for the NIH website http://www.niaid.nih.gov/)

Botulism, Campylobacteriosis, E. coli, Hepatitis A, Norovirus Infection, Salmonellosis, Shigellosis, Prevention

So how do you avoid these unpronounceable diseases?  Besides the information provided on the links to each disease, you might also want to make note of the following helpful suggestions

No matter how busy you are, from top to bottom, a clean kitchen is a main line of defense for your family and the prevention of food poisoning.  You simply must eliminate the breeding grounds for dangerous bacteria.

  •  Wash your hands often – front and back, between fingers, under fingernails – in warm soapy water for at least 20 seconds (or two choruses of “Happy Birthday”) before and after every step in preparing or eating foods. That includes your kitchen helpers, such as children.
  • Clean all work surfaces often to remove food particles and spills. Use hot, soapy water. Keep nonfood items – mail, newspapers, purses – off counters and away from food and utensils. Wash the counter carefully before and after food preparation.
  • wash dishesWash dishes and cookware in the dishwasher or in hot, soapy water, and always rinse them well. Remember that chipped plates and china can collect bacteria.
  • Change towels and dishcloths often and wash them in the hot cycle of your washing machine. Allow them to dry out between each use. If they are damp, they’re the perfect breeding ground for bacteria.
  • Throw out dirty sponges or sterilize them by rinsing the sponge and microwaving it for about two minutes while still wet. Be careful, the sponge will be hot.

Pay close attention to the refrigerator and the freezer – shelves, sides and door – where foods are stored. Pack perishables in coolers while you clean or defrost your refrigerator or freezer.

Splatters inside your microwave can also collect bacteria, so keep it clean.

Physical Hazards

We’ve talked a lot about diseases and illnesses but our health is also subject to physical hazards.  You can view a University of Nebraska Slide show on the subject here: http://tinyurl.com/k6k4qow

What is a physical hazard?

We’ve all heard the stories about Rocks, insects and other things showing up in soda and beer cans.  While those instances are rare, they still happen.  Any extraneous object or foreign matter in food which may cause illness or injury to a person consuming the product is a physical hazard. These objects include bone or bone chips, metal flakes or fragments, injection needles, BB’s or shotgun pellets, pieces of product packaging, stones, glass or wood fragments, insects, personal items, or any other foreign matter not normally found in food.

The 8 most common food categories implicated in reported foreign object complaints are bakery products, soft drinks, vegetables, infant’s foods, fruits, cereals, fishery products and chocolate and cocoa products.  Below you will find a list of hazards, their effect and the treatment.  You can find more detailed information by clicking on this link http://tinyurl.com/mbktawq

These materials have been found in food and can cause severe trauma, bleeding, cuts and even death.  In many cases surgery is required to correct the damage caused by; Glass, wood, stones, bullets, BBs, needles, jewelry, metal, .Insects and other contaminated material, building materials, bone, plastic and personal effects

As with any topic it is sometimes difficult to separate fact from fiction.  There are so many rumors, old Wives tales and myths people often think they are doing the right thing when in fact they may be making matters worse.  We can’t dispel all the rumors, but we can address a few.

Food Safety Myths Exposed

http://www.foodsafety.gov/keep/basics/myths/

We all do our best to serve our families food that’s safe and healthy, but some common myths about food safety might surprise you.

MYTH: Food poisoning isn’t that big of a deal. I just have to tough it out for a day or two and then it’s over.

FACT: Many people don’t know it, but some foodborne illnesses can actually lead to long-term health conditions, and 5,000 insectAmericans a year die from foodborne illness. Get the FACTs on long-term effects of food poisoning.

MYTH: It’s OK to thaw meat on the counter. Since it starts out frozen, bacteria isn’t really a problem.

FACT: Actually, bacteria grow surprisingly rapidly at room temperatures, so the counter is never a place you should thaw foods. Instead, thaw foods the right way.

MYTH When cleaning my kitchen, the more bleach I use, the better. More bleach kills more bacteria, so it’s safer for my family.

FACT: There is actually no advantage to using more bleach than needed. To clean kitchen surfaces effectively, use just one teaspoon of liquid, unscented bleach to one quart of water.

MYTH I don’t need to wash fruits or vegetables if I’m going to peel them.

FACT: Because it’s easy to transfer bacteria from the peel or rind you’re cutting to the inside of your fruits and veggies, it’simportant to wash all produce, even if you plan to peel it.

poultryMYTH: To get rid of any bacteria on my meat, poultry, or seafood, I should rinse off the juices with water first.

FACT: Actually, rinsing meat, poultry, or seafood with water can increase your chance of food poisoning by splashing juices (and any bacteria they might contain) onto your sink and counters. The best way to cook meat, poultry, or seafood safely is tomake sure you cook it to the right temperature.

MYTH: The only reason to let food sit after it’s been microwaved is to make sure you don’t burn yourself on food that’s too hot.

FACT: In FACT, letting microwaved food sit for a few minutes (“standing time”) helps your food cook more completely by allowing colder areas of food time to absorb heat from hotter areas of food.

MYTH: Leftovers are safe to eat until they smell bad.

FACT: The kinds of bacteria that cause food poisoning do not affect the look, smell, or taste of food. To be safe, use our Safe Storage Times chart to make sure you know the right time to throw food out.

MYTH: Once food has been cooked, all the bacteria have been killed, so I don’t need to worry once it’s “done.”

FACT: Actually, the possibility of bacterial growth actually increases after cooking, because the drop in temperature allows bacteria to thrive. This is why keeping cooked food warmed to the right temperature is critical for food safety.

MYTH: Marinades are acidic, which kills bacteria—so it’s OK to marinate foods on the counter.

FACT: Even in the presence of acidic marinade, bacteria can grow very rapidly at room temperatures. To marinate foods safely, it’s important to marinate them in the refrigerator.

MYTH: If I really want my produce to be safe, I should wash fruits and veggies with soap or detergent before I use them.

FACT: In FACT, it’s best not to use soaps or detergents on produce, since these products can linger on foods and are not safe for consumption. Using clean running water is actually the

cookie doughMYTH: Only kids eat raw cookie dough and cake batter. If we just keep kids away from the raw products when adults are baking, there won’t be a problem!

FACT: Just a lick can make you sick!
No one of any age should eat raw cookie dough or cake batter because it could contain germs that cause illness. Whether it’s pre-packaged or homemade, the heat from baking is required to kill germs that might be in the raw ingredients. The finished, baked, product is far safer – and tastes even better! So don’t do it! And remember, kids who eat raw cookie dough and cake batter are at greater risk of getting food poisoning than most adults are.

MYTH: When kids cook it is usually “heat and eat” snacks and foods in the microwave. They don’t have to worry about food safety – the microwaves kill the germs!

FACT: Microwaves aren’t magic!
It’s the heat the microwaves generate that kills the germs! Food cooked in a microwave needs to be heated to a safe internal temperature. Microwaves often heat food unevenly, leaving cold spots in food where germs can survive. Kids can use microwaves properly by carefully following package instructions. Even simple “heat and eat” snacks come with instructions that need to be followed to ensure a safe product. Use a food thermometer if the instructions tell you to!

MYTH: When kids wash their hands, just putting their hands under running water is enough to get the germs off.

How to wash handsFACT: Rubbing hands with water and soap is the best way to go!
Water is just part of what you need for clean hands! Washing hands properly is a great way to reduce the risk of food poisoning. Here’s how: Wet your hands with clean, running water and apply soap. Rub them together to make a lather and scrub them well; be sure to scrub the backs of hands, between fingers, and under nails. Continue rubbing for at least 20 seconds. Sing the “Happy Birthday” song twice to time yourself! Rinse hands well under running water. Dry your hands using a clean towel, paper towel, or an air dryer.

MYTH: My kids only eat pre-packaged fruits and veggies for snacks because those snacks don’t need to be washed before they eat them.

FACT: Read your way to food safety!
Giving your kids healthy snacks is a big plus for them! But just because produce is wrapped, it doesn’t always mean it’s ready to eat as is. Read the label of your product to make sure it is says: “ready-to-eat,” “washed,” or “triple washed.” If it does, you’re good to go! If it doesn’t, wash your hands and then rinse the fruits or vegetables under running tap water. Scrub firm items, such as melons and cucumbers, with a clean produce brush. Dry with a clean cloth towel or paper towel to further reduce germs that may be present.

While federal, state and local agencies provide a valuable service with their contributions to our food safety, the primary responsibility is yours.  Too many of us become too careless with our food preparation and storage procedures and each of us needs to pay far more attention to the cleanliness of the areas in which we prepare food and to the cleanliness of the food itself.

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bob minus Jay full shotBob Aronson of Bob’s Newheart is a 2007 heart transplant recipient, the founder of Facebook’s over 4,000 member Organ Transplant Initiative (OTI) and the author of most of these donation/transplantation blogs. You may comment in the space provided or email your thoughts to me at bob@baronson.org.  And – please spread the word about the immediate need for more organ donors. There is nothing you can do that is of greater importance. If you convince one person to be an organ and tissue donor you may save or positively affect over 60 lives. Some of those lives may be people you know and love.  You can register to be a donor at http://www.donatelife.net.  It only takes a few minutes.

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EBOLA — WHAT YOU NEED TO KNOW


By Bob Aronson

statue of libertyOver the years this blog has offered a lot of information on how to take care of your organs.  We believe strongly that the way to solve the shortage of transplantable organs is to 1) encourage donation and 2) do everything possible to reduce the demand.  That means we must continually be on guard  to prevent threats to our health and we depend on public health officials and the news media to provide us with that information.  Ebola is the latest threat and it’s a dandy. It can destroy all of your organs — all of them.

After watching the Ebola story develop in the past few weeks I came to the conclusion that we are getting mixed messages from a number of sources and the mass media doesn’t do a very good job of filtering them, they just hop,  skip and jump from one new development to another with little effort given to finding and tying loose ends.

To date most of the regular TV news stories on the Dallas, Texas Ebola incident lack detail and as a result serve no purpose but to inflame, confuse and cause panic.  Print stories have been better but it has been hard to find many really comprehensive reports.   That’s probably because Ebola is a moving target.  Just as I was about to publish this blog, there were two new developments.

The first new development is that one of the health care workers at the Dallas hospital where the first Ebola patient died, has tested positive for the Ebola Virus.  This is a breaking news story so it won’t be covered in detail here.  The second development today is from President Obama’s National Security advisor Susan Rice who is expressing some dismay at the sorry state of the world response to the Ebola Threat. She is not so subtly sounding the alarm and calling for “All hands on Deck.”

With the exception of some investigative or in-depth network reports, TV news channels have been saying pretty much the same thing.  As the story goes, a man who had recently traveled from Liberia in West Africa to Dallas, Texas checked into an emergency room at Presbyterian hospital there with a temperature of 103 degrees.  He was treated for a stomach virus and sent home.  That’s pretty much what most people know about the Dallas situation and the Ebola virus.  The story, though, is grossly incomplete.  That is not to say the hospital in question should be exonerated of any responsibility, they should not, but nothing is ever as simple as it sounds.

It is important first, to understand what we are dealing with.  Ebola hemorrhagic fever (EHF), caused by the Ebola virus, is a severe viral hemorrhagic disease characterized by initial fever and malaise followed by gastrointestinal symptoms, bleeding, shock, and multi-organ system failure. Over 25 different viruses cause viral hemorrhagic fever. Ebola virus is a member of the virus family Filoviridae, along with Marburg virus.

EHF is difficult to distinguish from a host of other febrile illnesses, at least early in the course of disease. Other viral hemorrhagic fevers need to be excluded, especially Marburg hemorrhagic fever, as well as malaria and typhoid fever.

Patients should be isolated and viral hemorrhagic fever precautions (face shields, surgical masks, double gloves, surgical gowns, and aprons) should be used to prevent transmission. As there is presently no antiviral drug available for EHF, treatment is supportive, following the guidelines for treatment of severe septicemia. Persons who had unprotected contact with someone with EHF should be monitored.  Case fatality rates vary consistently with the specific infecting virus, ranging from zero to over 80%.

I spent 25 years of my life as a communication consultant and specialized in working with health care organizations like infection controlclinics, hospitals, research centers, pharmaceutical companies, research labs and more.  I know how important infection/contagion control is in these facilities and how much time, effort and money is spent on programs to ensure patient safety.  That’s why what happened in Dallas with the Ebola patient stands out.  Numerous studies make it very clear that in the great majority of cases in which patient safety is at risk communication is the culprit.

While Ebola may sometimes be difficult to diagnose, every hospital and clinic in this country has check lists on contagious diseases and infections.  They do regular drills, have training sessions and should be well prepared for any eventuality.  What happened in Dallas shouldn’t have happened, but it did.  Now what?

Dr. Anthony FauciDr. Anthony Fauci from the National Institutes of Health (NIH) an acknowledged expert on infectious diseases says that while he understands our fears we also need to understand that what is happening in West Africa is because of the weaknesses in their health system.  “West Africa,” he says, “Is not the United States, we won’t have an outbreak. Scientists know how to stop the virus from spreading.”

While I hope he is right, I wish Dr. Fauci had not said that.  Knowing how to do something and actually accomplishing it may be worlds apart.  This isn’t just about the medical profession knowing what to do, it is about all of us knowing what to do and when — and then communicating properly and following the plan.  Nothing, Dr. Fauci, is as easy as it seems. and your overly simplistic assurances could be harmful, lulling us into a false sense of security. I’ll explain more shortly.

An ABC News report tells a story that differs from Dr. Fauci’s view.   The Network account quoted Dr. Ryan Stanton, an emergency room physician in Lexington, Kentucky, and spokesman for the American College of Emergency Physicians as saying, “We’re all a little bit on edge because we’ve never seen it before.  Stuff we’ve seen before, like heart attack and stroke, we recognize as soon as we walk in the door. For Ebola, it’s not going to come as naturally.  It’s not even a needle in a haystack,” he went on. “It’s a needle in a hayfield we’re trying to find.”  That statement kind of casts some doubt on Dr. Fauci’s position.  Add the Susan Rice comments to the mix and Dr. Fauci is sounding far too positive.  If after reading this far you think, “There’s more to the Ebola outbreak than meets the eye,” you’d be right.  There is.

The question on everyone’s mind is, “How could the ER people in Dallas have missed this case?  Well, they did not miss it, it kind of missed them.  Dallas presbyterian We have it on good authority that the Dallas ER nurse properly accounted for the feverish patient’s recent travel in Africa, but that information did not get communicated to the rest of the team. Instead, the patient was treated with antibiotics for a presumed run-of-the-mill stomach virus. So it appears that while the checklist was completed poor team communication prevented its proper execution.

It is entirely possible that the Nurse’ proper reaction was ignored for any number of reasons. 1) It came from a nurse, not a doctor (yes, there is institutional, professional arrogance) 2. The team was busy, tired and careless and chose to ignore the Nurse’ efforts and 3) the Nurse did not communicate with the right people and the communication was unclear, unreadable or could not be heard. I suspect that there might be a dozen more reasons or excuses as well.

I am not qualified to argue medical facts with Dr. Fauci — I don’t even want to and the reason is simple, he is right.  What he said is absolutely correct.  The medical profession does know how to stop Ebola.  What they don’t do very well,  is communicate what they know to those of us who don’t.

After 25  years of working as a communications coach and consultant to the medical profession I can tell you that communication is not one of their strong suits.  I have great respect for physicians and loved working with them but their ability to speak in understandable and memorable terms is not a well developed skill.  Think about your interactions with your doctors and how many times you leave his or her office saying, “I don’t think my questions got answered,” or, “What did he mean when he said,….”

But, let’s go back to the Dallas case.  I do not doubt that the Dallas medical team knew how to deal with Ebola.  The question that is at the core of the issue, though is, “How effective was the communication they used to put the systems in place to accomplish that end?  It is not their medical expertise I doubt, it is their ability to communicate what they know and suspect in an effective and understandable manner.   And — if the patient safety record in American health care institutions is any indication of that prowess then we are in a heap of trouble. This is where the Fauci assurances fall flat.  A 2013 story in Forbes Magazine said: http://www.forbes.com/sites/leahbinder/2013/09/23/stunning-news-on-preventable-deaths-in-hospitals/

Forbes logo“In 1999, Americans learned that 98,000 people were dying every year from preventable errors in hospitals. That came from a widely touted analysis by the Institute of Medicine (IOM) called To Err Is Human. This was the “Silent Spring” of the health care world, grabbing headlines for revealing a serious and deadly problem that required policy and action.

As it turns out, those were the good old days.

According to a new study just out from the prestigious Journal of Patient Safety, four times as many people die from preventable medical errors than we thought.  That could be as many as 440,000 deaths a year.

With these latest revelations, medical errors now claim the spot as the third leading cause of death in the United States, dwarfing auto accidents, diabetes and everything else besides Cancer and heart disease.

These people are not dying from the illnesses that caused them to seek hospital care in the first place. They are dying from mishaps that hospitals could have prevented. What do these errors look like? The sponge left inside the surgical patient, prompting weeks of mysterious, agonizing abdominal pain before the infection overcomes bodily functions. The medication injected into a baby’s IV at a dose calculated for a 200 pound man. The excruciating infection from contaminated equipment used at the bedside. Sadly, over a thousand people a day are dying from these kinds of mistakes.

If you aren’t alarmed enough that our country is burying a population the size of Oakland every year, try this: you are paying for it. Hospitals shift the extra cost of errors onto the patient, the taxpayer and/or the business that buys health benefits for the infected patient. My nonprofit, which provides a calculator of the hidden surcharge Americans pay for hospital errors, finds most companies are paying millions or even billions of extra dollars for the cost of harming their employees.

No Cure,  No Vaccine Because There’s No Money In It

A recurring question in the case of Ebola or diseases like it is, “Why don’t we have a vaccine or a cure?”  Part of the answer to that orphan diseasesquestion is that diseases like Ebola and Marburg fall into the “Orphan disease” category. These are very rare diseases.  The rarity of the diseases provides little incentive for private industry to invest in research and development because the cost per prescription or treatment per patient would be so high few could afford them.  There is some government assistance for research but nowhere near enough.

The Orphan Drug Act of 1983 http://tinyurl.com/3vkffup provides incentives for drug companies to develop treatments for rare diseases. Since the Act was signed into federal law, the U.S. Food and Drug Administration (FDA) has approved more than 200 treatments for rare diseases.

While that number sounds good it is small when put in perspective because there are about 7,000 orphan diseases and some are quite familiar like:

  • Cystic fibrosis, which affects the respiratory and digestive systems.
  • Huntington disease which affects the brain and nervous system.
  • Single genes are also responsible for some rare, inherited types of Examples of these are the BRCA1 and BRCA2 genes, in which certain mutations increase the risk for hereditary breast and ovarian cancers, and the FAP gene, in which mutations increase the risk for hereditary colon cancer.

You can find more information here http://rarediseases.info.nih.gov/about-ordr/pages/31/frequently-asked-questions

As noted the Orphan Drug Act is why there is any activity around Orphan diseases, but it is nowhere near enough because there are so many of them.

Thanks to marketing campaigns aimed at people exposed to asbestos we are all likely familiar with the disease called mesothelioma — perhaps the best-known orphan disease in the nation.

About 3,000 patients are diagnosed with mesothelioma each year, placing it well within the U.S. definition of a rare or orphan disease as one that affects no more than 200,000 patients at a given time.  To further complicate matters there are several different forms of the disease so what might work to control one, likely wouldn’t for another. Patients with mesothelioma live for 1 to 2 years past their diagnosis.
mesothelioma“One of the difficult aspects of mesothelioma is that it often not diagnosed until it is in the later stages, and it is a very aggressive cancer,” says Joe Belluck, a New York mesothelioma lawyer.

The disease is difficult to detect since symptoms come after asbestos fibers have invaded organ linings and often mimic that of a bad cold or virus. It also surfaces decades after exposure to asbestos, so it has historically affected an older population with age-related health

It is a very deadly form of cancer and one that falls into the “Orphan” category. Mesothelioma is listed as an orphan disease on registries like rarediseases.org maintained by the National Organization for Rare Diseases (NORD).

Because it affects fewer than 200,000 people at a given time (due to its high mortality rate), treatments specifically for mesothelioma are eligible for orphan drug funding from the Food and Drug Administration (FDA). Under the Orphan Drug Act, companies involved in developing and testing drugs, biologics, and other treatments specifically to treat rare diseases can get tax credits and other incentives to continue development them including:

  • 7 years of exclusive marketing for the drug
  • Tax credits to cover half the cost of clinical investigations
  • Waiving user fees

As you can see, there is far more to the Ebola story than meets the eye.  It is a complex issue because Ebola is an Orphan disease that attacks in a multitude of ways and is not always easy to identify.  So what can you do?  Be informed. Don’t wait for information, seek it out, you might save your life and the lives of people you love.  Below are some essential facts, but click on the links, too.

Here are some fast facts on Ebola from CNN:  http://tinyurl.com/npqfzt2

CNN Eb0la Fact Sheet

Ebola hemorrhagic fever is a disease caused by one of five different Ebola viruses. Four of the strains can cause severe illness inCNN humans and animals. The fifth, Reston virus, has caused illness in some animals, but not in humans.

The first human outbreaks occurred in 1976, one in northern Zaire (now Democratic Republic of the Congo) in Central Africa: and the other, in southern Sudan (now South Sudan). The virus is named after the Ebola River, where the virus was first recognized in 1976,according to the Centers for Disease Control and Prevention.

Ebola is extremely infectious but not extremely contagious. It is infectious, because an infinitesimally small amount can cause illness. Laboratory experiments on nonhuman primates suggest that even a single virus may be enough to trigger a fatal infection.

Instead, Ebola could be considered moderately contagious, because the virus is not transmitted through the air, well at least not much.  A sneeze could spread it if the droplets  from an infected person come in contact with someone who is not, but that’s a very short distance.  In the most contagious diseases, such as measles or influenza, virus particles are airborne for longer distances and much more time.

Humans can be infected by other humans if they come in contact with body fluids from an infected person or contaminated objects from infected persons. Humans can also be exposed to the virus, for example, by butchering infected animals.

While the exact reservoir of Ebola viruses is still unknown, researchers believe the most likely natural hosts are fruit bats.

Symptoms of Ebola typically include: weakness, fever, aches, diarrhea, vomiting and stomach pain. Additional experiences include rash, red eyes, chest pain, throat soreness, difficulty breathing or swallowing and bleeding (including internal).

Typically, symptoms appear 8-10 days after exposure to the virus, but the incubation period can span two to 21 days.

Unprotected health care workers are susceptible to infection because of their close contact with patients during treatment.

Ebola is not transmissible if someone is asymptomatic or once someone has recovered from it. However, the virus has been found in semen for up to three months.

Deadly human Ebola outbreaks have been confirmed in the following countries: Democratic Republic of the Congo (DRC), Gabon, South Sudan, Ivory Coast, Uganda, Republic of the Congo (ROC), Guinea and Liberia.

According to the World Health Organization, “there is no specific treatment or vaccine,” and the fatality rate can be up to 90%. Patients are given supportive care, which includes providing fluids and electrolytes and food.

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I  hope this report helped to clarify the Ebola issue. If you have comments make them in the space provided or contact me directly at bob@baronson.org.bob cropped smaller

Bob Aronson of Bob’s Newheart is a 2007 heart transplant recipient, the founder of Facebook’s over 4,000 member Organ Transplant Initiative (OTI) and the author of most of these donation/transplantation blogs. You may comment in the space provided or email your thoughts to me at bob@baronson.org. And – please spread the word about the immediate need for more organ donors. There is nothing you can do that is of greater importance. If you convince one person to be an organ and tissue donor you may save or positively affect over 60 lives. Some of those lives may be people you know and love.

Got “Low T?” Buyer Beware — the Therapy May Not Be Safe!


By Bob Aronson

Almost everyone is familiar with the commercials and ads that offer relief for men suffering from “Low T.”   Most interpret that to mean “diminished sex drive” and there is no end to the number of claims of treatments and/or cures.  Bottom line?  They are selling sex.  The manufacturers   of “Low T” products, physicians, clinics and therapists are pandering to the male fear of erectile dysfunction and there’s absolutely no guarantee that any of the products will work.  Worse yet, they could kill you.

The ads produced by those who are promoting Testosterone therapy amount to fear mongering at itskeep it up ad...
worst.  Nothing will destroy a man’s ego faster than an inability to perform in bed and many will go to any extreme to make sure that doesn’t happen.  If you could drill deeply into the male ego you likely would find that the ability to get and hold an erection is extremely important and when that ability is lost even once, many men will feel as though they have lost their manhood and that their life is over. The ads posted here are real.

low T sexual image ad

 

low t ad

 

 

The “Low T” condition should not be taken lightly, if in fact that is an accurate diagnosis.  Unfortunately the number of physicians and others who offer that diagnosis is far greater than the number who are qualified to do so or who even perform a thorough examination

In 2013, 2.3 million men received a prescription for testosterone, up from 1.3 million in 2010, according to the U.S. Food and Drug Administration (FDA).  About 70 percent of men prescribed testosterone drugs were between the ages of 40 and 64.

According to an FDA analysis, 21 percent of patients prescribed testosterone drugs did not appear to have had their testosterone concentrations tested before or during treatment, something the agency described as “concerning.”

Ofda logo 2n Tuesday, September 17, 2014 an FDA advisory panel said that Testosterone replacement therapies should be “Reserved for men with specific medical conditions that impair function of the testicles.”  While the FDA is not obligated to follow advisory panel advice, it typically does.  The panel also recommended that companies be required to conduct additional studies to assess the cardiovascular risk of their products for patients with age-related low testosterone.

Symptoms of low testosterone include loss of libido, decreased muscle mass, fatigue and depression.

The panel voted 20-1 in favor of restricting the drugs’ authorization to people with medically related low testosterone, such as a tumor or genetic disorder.

If the FDA acts on the recommendation companies could not market or promote their products for age-related low testosterone, but physicians would still have the right to prescribe products “off label” in any way they choose.  An important lesson for consumers is that just because a physician prescribes it, doesn’t mean it’s right for you.

What is Testosterone?

The Mayo Clinic says this: Testosterone is a hormone produced primarily in the testicles. Testosterone helps maintain men’s:

  • Bone density
  • Fat distribution
  • Muscle strength and mass
  • Red blood cell production
  • Sex drive
  • Sperm production

Hypogonadism is a disease in which the body is unable to produce normal amounts of testosterone due to a problem with the testicles or with the pituitary gland that controls the testicles. Testosterone replacement therapy can improve the signs and symptoms of low testosterone in these men. Doctors may prescribe testosterone as injections, pellets, patches or gels.

What are the Risks of Testosterone Therapy?

Also according to the Mayo Clinic http://www.mayoclinic.org/healthy-living/sexual-health/in-depth/testosterone-therapy/art-20045728?pg=2

Testosterone therapy has various risks. For example, testosterone therapy may:

  • Contribute to sleep apnea — a potentially serious sleep disorder in which breathing repeatedly stops and starts
  • Increase your risk of a heart attack
  • Cause acne or other skin reactions
  • Stimulate noncancerous growth of the prostate (benign prostatic hyperplasia) and growth of existing prostate cancer
  • Enlarge breasts
  • Limit sperm production or cause testicle shrinkage
  • Increase the risk of a blood clot forming in a deep vein (deep vein thrombosis), which could break loose, travel through your bloodstream and lodge in your lungs, blocking blood flow (pulmonary embolism)

The American Recall Center  http://www.recallcenter.com is a consumer oriented groupAmerican recall center logo with the following vision.  “At the American Recall Center, we aim to give pertinent information on FDA warnings for prescription drugs and medical devices. Through our extensive library of recalls and medical information, and our experienced editorial team, it is our mission to empower those who have been adversely affected.”  In other words, they monitor the health care environment and provide accurate and timely information about drugs, procedures, devices and practices that affect individual Americans.

Recently I was contacted by The American Recall Center http://www.recallcenter.com and alerted to their concerns about Testosterone Therapy and the various actions being taken with regard to the practice.  I looked carefully at what they had to say and also conducted my own brief investigation that resulted in verification of their claims.  What follows is a direct copy from their website.  It is alarming and should be taken very seriously by anyone either undergoing such therapy or considering it.

lawsuit imageTESTOSTERONE LAWSUIT

http://www.recallcenter.com/featured-topics/testosterone-replacement-therapy/testosterone-recall/

The treatment of low testosterone (also known as hypogonadism or Low-T) in men has increased significantly since the year 2000. However, with the growth of such testosterone replacement therapy, there has also been an increase in the number of studies that have shown a link to various medical problems, such as the increased risk of heart attacks, strokes and other potentially deadly outcomes. As a result, the FDA has issued several statements on the use of testosterone therapy, and a number of lawsuits have been filed claiming that treatments to combat low testosterone have resulted in harm to the patient or even fatalities.

FDA Investigation and Testosterone Replacement Therapy

Although the FDA has not issued any recalls of testosterone due to the possibly dangerous nature of various treatments, early in 2014 the agency published an alert stating that it was going to begin investigating the potentially adverse outcomes of testosterone supplements. Specifically, the FDA denied any conclusions related to increased probability of heart attacks, strokes or death in men undergoing testosterone replacement therapy. However, the agency said that would analyze data from multiple studies and monitor side effects of testosterone treatments as reported through its MedWatch program. The FDA also advised patients and physicians to understand both the risks and the benefits of drugs and supplements before beginning any treatment.1

In June 2014, the FDA announced that it manufacturers of testosterone would be required to add a warning label to their products indicating the possible formation of blood clots in patients’ veins. The agency stressed that this requirement was unrelated to the separate investigation into the other health problems that may be associated with testosterone use.2

Testosterone Lawsuits and Multidistrict Litigation

As a result of the potentially dangerous consequences of taking various low-testosterone treatments — which are available as topical gels, transdermal patches, buccal systems, subcutaneous pellets and injections — a significant number of lawsuits have been filed against manufacturers of testosterone products.

Because of the large number of cases related to testosterone products, and the even larger number of potential future case that could expand into the thousands, the United States Judicial Panel on Multidistrict Litigation has created MDL No. 2545 to handle actions related to testosterone products. In the original order, the panel noted its hesitancy to encompass an entire industry with a broad range of products under a single MDL. However, the panel members acknowledged that even among different products and across competing companies, many of the claims associated with the testosterone cases have common discovery, and thus are suitable for MDL status.

At the time of the original order on June 6, 2014, forty-five cases across four districts were pending. Since then, additional cases have been added.4

Testosterone Manufacturers Facing Lawsuits

The following table lists companies that have faced lawsuits related to their testosterone treatments, along with the names of some commonly known testosterone products they have developed. Other companies also may have faced litigation for their testosterone products.

COMPANY TESTOSTERONE PRODUCT(S)
AbbVie Inc./Abbott Laboratories Inc. AndroGel
Eli Lilly and Co./Lilly USA LLC Axiron
Endo Pharmaceuticals Aveed, Delatestryl, Fortesta
Actavis, Inc. ANDA, LibiGel, Testosterone Enanthate Injection USP, Testosterone Cypionate Injection USP, AndroDerm
Auxilium Pharmaceuticals, Inc. Testim, Testosterone Gel CIII, Testopel, Striant
Pfizer, Inc./Pharmacia & Upjohn Co. Depo-Testosteroneh, Depo-Testadiol

Alternatives?

According to Healthline (http://www.healthline.com/health/low-testosterone/natural-boosters#1),  there are some alternatives to Testosterone Therapy and while there’s no guarantee they will work, there is no guarantee the therapy will work either and these alternatives, unlike the therapy, won’t hurt you.

Additionally, following these suggestions can help your general health as well as low testosterone production.  Try them, you have nothing to lose and a better life to gain.

  1. Get a Good Night’s Sleep

It doesn’t get more natural than a good night’s sleep. A University of Chicago study showed that lack of sleep can greatly reduce a healthy young man’s testosterone levels. That effect is clear after only one week of shortened sleep. Testosterone levels were particularly low between 2:00 and 10:00 p.m. on sleep-restricted days. Study participants also reported a decreased sense of well-being as their blood testosterone levels dropped.

How much sleep your body needs depends on many factors, but theNational Sleep Foundation suggests that adult males generally need between seven and nine hours per night.

  1. Lose That Excess Weight

It is not uncommon for overweight, middle-aged men with prediabetes to also have low testosterone levels. A 2012 study revealed that weight loss among men with prediabetes improved their testosterone levels by almost 50 percent.

These findings don’t mean you have to go on a crash diet. The healthiest way to achieve and maintain a healthy weight is through a sensible diet and regular exercise.

  1. Get Enough Zinc

Men with hypogonadism generally have zinc deficiencies. Studiessuggest that zinc plays an important part in regulating serum testosterone levels in healthy men.

According to the Office of Dietary Supplements, adult males should get 11 mg of zinc and females should get 8 mg of zinc each day. Oysters have a lot of zinc. It is also found in red meat and poultry. Other food sources include beans, nuts, crab, lobster, whole grains, and many fortified foods.

  1. Go Easy on the Sugar

Zinc isn’t enough to ensure you’re getting the all the nutrition you need. The human body is a complex system that requires a wide variety of vitamins and minerals for smooth operation.

Research published by The Endocrine Society shows that glucose (sugar) decreases testosterone levels in the blood by as much as 25 percent. This was true of study participants whether they had prediabetes, diabetes, or a normal tolerance for glucose.

  1. Get Some Good Old-Fashioned Exercise

Studies show an increase in total testosterone levels after exercising, especially after resistance training. Low testosterone levels can affect your sex drive and your mood, but the good news is that exercise improves mood and stimulates brain chemicals that help you feel happier and more confident. Exercise also boosts energy and endurance and helps you sleep better. All that can help with your sex drive and sexual performance, too. Fitness experts recommend 30 minutes of exercise every day.

Avoid Alcohol.  And…a final tip and this one is mine.  If you are concerned about your ability to perform sexually you should know that consuming alcohol will not help.  Alcohol often will present two contradictory effects.  The first effect is that it will diminish your inhibitions and therefore boost your desire for sex.  Unfortunately, the increased desire is usually met with a decreased ability to get an erection.  You get all dressed up with nowhere to go.

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bob minus Jay full shotBob Aronson of Bob’s Newheart is a 2007 heart transplant recipient, the founder of Facebook’s over 4,000 member Organ Transplant Initiative (OTI) and the author of most of these donation/transplantation blogs. You may comment in the space provided or email your thoughts to me at bob@baronson.org. And – please spread the word about the immediate need for more organ donors. There is nothing you can do that is of greater importance. If you convince one person to be an organ and tissue donor you may save or positively affect over 60 lives. Some of those lives may be people you know and love.

DEA Bullying Denies Relief to Those With Chronic Pain


By Bob Aronson

morphine is the best medicine 

I suffer from Chronic Pain and do millions of others and it’s getting more and more difficult to get any relief from it because two federal agencies are bullying physicians.

My neck and shoulder pain started after my heart transplant and some of it was directly related to the position of my arms while I was in surgery.  Many transplant recipients suffer the same fate, but transplant or not if a person is in pain relief should be no farther away than your doctor’s office.  It’s not!

I have received dozens of messages from pain sufferers since I published the previous two posts on the subject of chronic pain and physicians who simply will not prescribe narcotics (1. Why You Can’t Get Pain Meds http://tinyurl.com/knltszh   and (2. Suffering from Chronic Pain? Here’s what you need to know http://tinyurl.com/lzy8o22 and that’s what prompted me to write this third blog on the subject. I’m angry, frustrated and helpless.

The U.S. Drug Enforcement Administration (DEA) mission (more on that later)dea badge is essentially to stop the production and sale of illegal drugs in America. Their “War on Drugs” is well known and it has recently expanded from the poppy fields to the practice of medicine and to pharmacies. 

A few years ago Florida was the state of the “Pill Mills,” places where almost anyone could get powerful prescription pain killers just by showing up at the Doctor’s office. So flagrant were the violations that the DEA had a pill mill 2heyday of arrests and convictions but like many federal agencies they didn’t know when to stop.  Not satisfied with putting the “Pill Mill” docs out of business, they turned to the regular physicians and warned them of investigations and loss of license if they were found to be prescribing narcotic pain meds to people who weren’t in pain.

Many physicians who saw the DEA overreaction to the “Pill Mills” overreacted themselves and decided not to prescribe opioids (narcotics or controlled substances) to anyone.  The result is that many who suffer from chronic pain that cannot be relieved by anything other than narcotics can’t get them and are suffering needlessly.

How chilling is the DEA’s action.  Try this on for size.  44% of American doctors confess that a fear of a police or DEA investigation into their practice influenced the way that they prescribed medications to chronic pain patients. This according to a poll of doctors for the Center for Addiction and Substance Abuse.

The DEA’s actions are harming patients and maybe it is because their mission is the most convoluted, overly broad, confusing detailed mess you’ll ever see. 

Here are three of examples of Mission Statement excellence

  • TED: Spreading Ideas. (2 words)
  • Smithsonian: The increase and diffusion of knowledge. (6 words)
  • USO lifts the spirits of America’s troops and their families. (9 words)
  • DEA (347 words)

(This is only part of it you can see the rest at http://www.justice.gov/dea/about/mission.shtml)

The mission of the Drug Enforcement Administration (DEA) is to enforce the controlled substances laws and regulations of the United States and bring to the criminal and civil justice system of the United States, or any other competent jurisdiction, those organizations and principal members of organizations, involved in the gDEA arrestrowing, manufacture, or distribution of controlled substances appearing in or destined for illicit traffic in the United States; and to recommend and support non-enforcement programs aimed at reducing the availability of illicit controlled substances on the domestic and international markets.

They wrote a mission statement that sets them up to invade anyone at any time for any reason.  If they were legitimately concerned with stopping the flow of illegal drugs their mission statement probably could have said. “The Mission of the DEA is to stop the production and sale of illegal drugs in the United States” (19 words).  Instead, they chose to write a book that gives them the authority to assume more authority.

Essentially what the DEA is talking about is Opioids so let’s start with a definition. opioids What is an Opioid?  According to the National Institute on Drug Abuse opioids are medications that relieve pain. They reduce the intensity of pain signals reaching the brain and affect those brain areas controlling emotion, which diminishes the effects of a painful stimulus.

Medications that fall within this class include hydrocodone (e.g., Vicodin), oxycodone (e.g., Oxycontin, Percocet), morphine (e.g., Kadian, Avinza), codeine, and related drugs. Hydrocodone products are the most commonly prescribed for a variety of painful conditions, including dental and injury-related pain. Morphine is often used before and after surgical procedures to alleviate severe pain. Codeine, on the other hand, is often prescribed for mild pain. In addition to their pain relieving properties, some of these drugs—codeine and diphenoxylate (Lomotil) for example—can be used to relieve coughs and severe diarrhea.

pain cartoonIn their zeal to accomplish the impossible mission the DEA has now ventured into the practice of medicine a discipline for which they are not qualified nor are they welcome.  As a result, thousands upon thousands of Americans are suffering incredible pain.  They can’t get relief because their physicians have been intimidated by the DEA and to a lesser degree the Food and Drug Administration (FDA).  We have here a sort of medical paradox, the feds want to practice medicine and the medical doctors are afraid to. 

This report from the Reuters news agency pretty much sums up the way many physicians are reacting to DEA’s bullying: “Many physicians have increased patient monitoring, which means more urine tests, more documentation, and more frequent “pill count” checks, where patients must go to the prescriber’s office with their pill bottles to prove they have not sold or misused their medication.

“Every hour of the day I have concerns I’ll be audited, that my ability to take care of my patients and my family can be taken away, and I’m as legitimate as you can get,” said one frazzled physicianprescriber who has a private orthopedic practice in Florida. “You’re constantly watching over your shoulder and it takes a toll,” he told Reuters news.

Safety and security are one thing but when a law enforcement agency decides to run rampant over a legitimate segment of the private sector, someone, somewhere ought to stand up and take notice.

In their long but terribly unsuccessful effort to control illegal drugs the DEA has now focused their attention on prescription drugs and in particular those few physicians (most of them were in Florida) who wrote narcotics prescriptions for nearly anyone who wanted them.  And…they’ve been successful. Most of the pill mills are gone, babrams tankut the DEA is like a runaway Abrams tank and is now rumbling over the medical profession.

In typical federal overreaction to the “Pill Mill” crisis, the DEA decided to crack down on all physicians by letting them know that they were being watched and that they had better be damned sure they were prescribing narcotics for real pain and not to junkies.

The overreaction by the Feds was met by an equal overreaction by many physicians.  They just quit prescribing opioid (narcotic) pain meds because they don’t want the hassle. Both the feds and the docs seem to have forgotten us patients.  We are the ones who get the short, sharp, infected end of the stick.

Not satisfied with their efforts, but impressed with their nearly effortless intimidation of the medical profession the DEA then decided that while they concentrated on powerful narcotics like oxycontin and oxycodone the effort should not stop there.  They also bullying imagewanted restrictions on a lower level of painkillers as well so they crossed the street and bullied the FDA into telling docs they had better be careful when they prescribe Vicodin and Lortabs.  Both contain hydrocodone and are usually combined with over the counter analgesics like aspirin or Tylenol.

The result?  If you suffer from chronic pain you are going to have a very difficult time getting any drug containing a narcotic or other controlled substance.  The medical profession has been scared to cause many docs to refuse to prescribe narcotics or any other controlled substance including drugs like Valium which is non-narcotic but still a controlled substance.

Many so-called “Pain Clinics” will not prescribe narcotics at all for any reason. Instead they will look for “root causes” and try a raft of anti-inflammatory and other treatments.  And, to be fair, in some cases those “other treatments” work, but while the pain experts are searching for non-opioid solutions, the patient suffers. I know I’m one of them.  When I asked one pain clinic doc for narcotics after repeated failed attempts to control my pain he said,”I can’t do that, see your primary.”  The “can’t” part of the answer is pure BS.  Won’t is the correct word to use — won’t because he has been intimidated by the feds.  I endured weeks of agonizing, debilitating pain because they refused to prescribe narcotics even though nothing else was working.

There are some docs who have the courage to practice medicine despite thewe are watching you fact that two powerful federal agencies are threatening them with a minimum of being investigated and a maximum of license revocation.  Physicians feel as though they are constantly being watched.

My primary care doc understands that I really do suffer from chronic pain and that I have tried other approaches that have failed.  Despite that, to protect his license he monitors my use of the Oxycodone he prescribes very carefully.  He requires that once a month, when it is time for a prescription refill he sees me in his office where he reviews my case, questions me about my pain level and then reminds me of the dangers of opioids even though I have never sought an increase in dosage and am not an addict.. 

I still believe that while the DEA and the FDA are being heavy handed, physicians who are licensed to practice medicine and fail to prescribe drugs that have been proven to be effective must bear some of the responsibility for the suffering many chronic pain patients are experiencing.  

eyes in the darkReminiscent of so many tyrannical regimes the DEA absolves itself of any responsibility for the suffering they have caused among patients with chronic pain.  Here’s what they told The National Pain Report.  

“The agency is not trying to limit access to opioid painkillers. And if legitimate pain medication prescriptions are not being written or filled, it’s the fault of doctors and pharmacists, not the government,” said DEA spokesman Rusty Payne. 

“We’re not doctors. We’re regulators and enforcers of the law. If something is prescribed for a legitimate medical purpose, we’re certainly not going to get in the way.  If a pharmacy chooses not to fill a prescription for someone, that’s their decision. It’s not the DEA’s decision,” he said.

To me that’s a whole lot like a cop stopping you for no good reason, warning you about speeding and then telling you that he and other cops are watching you very carefully to be sure you abide by all the rules.  Then, if due to fear you just quit driving they say, “That was his choice, we didn’t tell him to stop driving.”

So our bottom line is this. If you have chronic pain and all the non-narcotic remedies don’t work you are going to have to grin and bear it for a while.  No physician in this environment is going to write opioid prescription for someone who walks in from the street complaining of pain.  You are going to have to prove it.  Your chances of getting relief maybe better from your primary care physician but bring evidence of your pain

  • X-rays, MRIs, CT scans
  •  Written diagnosis, prognosis, treatment and instructions from other physicians or emergency departments
  •  Prescription records
  •  Police or other reports if you’ve had an injury
  • Reports from physical therapists or Chiropractors
  • Anything else that will help prove your claim that you have chronic pain and that opioids may be your only relief.

If you want a primary care physician to help you, it is going to take a little time to build a relationship and he or she may even want you to repeat some tests you have already undergone.  Be prepared to hurt for a while because it is unlikely that any physician you have not seen before will prescribe a narcotic pain killer after only one or two appointments.  That’s what our friends at DEA have done for us.

If all of this really gets under your skin, call, write, email, text, holler at or visit your Congressional Representative, Your Senator and/or The President of the United States.

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bob minus Jay full shotBob Aronson is a 2007 heart transplant recipient, the founder and primary author of the blogs on this site and the founder of Facebook’s over 3,000 member Organ Transplant Initiative group.

Now retired and living in Jacksonville, Florida with his wife Robin he spends his time advocating for patients with end stage diseases and for organ recipients.  He is also active in helping his wife with her art business at art festivals and on her Rockin Robin Prints site on Etsy. 

Bob is a former journalist, Governor’s Communication Director and international communications consultant.

 

 

How to Avoid Scams, Frauds, Quacks and Crooks


cartoon By Bob Aronson

When you have a serious illness you want relief and most often it does not come quickly or simply. The proper practice of medicine is measured, deliberate and often slow.  Medical experts depend on established scientific protocols to determine the effectiveness of treatments.  Because the mass media offer the same advertising and promotional opportunities to everyone it is often difficult to determine which ads are legitimate and which are not.  This blog aims to help you decide.

While there is no shortage of local, state and federal agencies who seek to protect consumers from scams, fraud and quackery there is no way that every offer made in the media, on the phone and through the internet can be monitored.  Your protection depends for the most part of your being alert to scams and can recognize offers that are without merit.  There is no shortage of frauds and crooks who scheme daily to find new ways to get you to part with your money. That means you must do everything possible to protect yourself.

The U.S. Food and Drug Administration (FDA) has broad responsibilities in its role as a consumer protection agency.  Here is just a part of what FDA is mandated to do:

“FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health.”

You can read more of the FDA’s mission here http://www.fda.gov/aboutfda/whatwedo/

Exposing fraud is but one aspect of the FDA’s role and there is no shortage of fraudulent claims being made.  You can find more by clicking on this link.: http://www.fda.gov/forconsumers/protectyourself/healthfraud/default.htm   Often companies make health claims about their products that not only are not true but can cause great harm, even death.  Here’s just one example of a medical claim deemed dangerous enough by the FDA to issue a public warning (I have edited the warning. For the official language go to http://tinyurl.com/m2u8s7b)

Public Notification: Pro ArthMax Contains Several Hidden Drug Ingredients

[1-15-2014] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Pro ArthMax, a product promoted and sold as a dietary supplement for joint, muscle and arthritic pain.

FDA laboratory analysis confirmed that Pro ArthMax contains the active ingredients diclofenac, ibuprofen, naproxen, indomethacin, nefopam, and chlorzoxazone.

  • Diclofenac, ibuprofen, naproxen, and indomethacin are NSAIDs which may cause increased risk of heart attack and stroke, as well as serious gastrointestinal damage including bleeding, ulceration, and fatal perforation of the stomach and intestines.
  • Chlorzoxazone is a muscle relaxant that is only available by prescription. Chlorzoxazone may cause drowsiness, dizziness, and lightheadedness, which may impair the ability to perform certain tasks, such as driving a motor vehicle or operating machinery.
  • Nefopam is a non-narcotic pain relieving drug that is not approved for marketing in the U.S. is not FDA-approved and its safety or efficacy has not been established.

arthritis drugConsumers should stop using this product immediately and throw it away. Consumers should consult a health care professional as soon as possible if they have experienced any negative side effects, such as unusually dark stools or urine, stomach pain, increased bruising, other signs of bleeding, confusion, sedation, hallucinations, and seizures.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Contact FDA Toll Free (855) 543-3784, or (301) 796-3400 druginfo@fda.hhs.gov

How to Recognize a Scam

There are thousands perhaps millions of scams that find their way into our lives every dayscam alert.  Some of them sound and look so legitimate we don’t recognize them until it is too late.

QuackWatch is a website run by a couple of physicians who keep an eye out for phony medical claims.  One such claim is that we all suffer from some sort of vitamin deficiency.  Stephen Barrett, M.D. and Victor Herbert, M.D., J.D. are pretty astute and have developed a list of 26 Ways to Spot Quacks and Vitamin Pushers.  I will list only a few here.  You can find the rest on their website. http://www.quackwatch.com/

They Claim That Most Americans Are Poorly Nourished

This is an appeal to fear that is not only untrue, but ignores the fact that the main forms of bad nourishment in the United States are obesity in the population at large (particularly the poor) and undernourishment among the poverty-stricken. Poor people can ill afford to waste money on unnecessary vitamin pills. Their food money should be spent on nourishing food.

It is falsely alleged that Americans are so addicted to “junk” foods that an adequate diet is exceptional rather than usual. While it is true that some snack foods are mainly “naked calories” (sugars and/or fats without other nutrients), it is not necessary for every morsel of food we eat to be loaded with nutrients. In fact, no normal person following the Dietary Guidelines for Americans is in any danger of vitamin deficiency.

They Say That Most Diseases Are Due to Faulty Diet
and Can Be Treated with “Nutritional” Methods.

This simply isn’t so. Consult your doctor or any recognized textbook of medicine. They will tell you that although diet is a factor in some diseases (most notably coronary heart disease), most diseases have little or nothing to do with diet. Common symptoms like malaise (feeling poorly), fatigue, lack of pep, aches (including headaches) or pains, insomnia, and similar complaints are usually the body’s reaction to emotional stress. The persistence of such symptoms is a signal to see a doctor to be evaluated for possible physical illness. It is not a reason to take vitamin pills

They Suggest That a Questionnaire Can Be Used
to Indicate Whether You Need Dietary Supplements.

questionaireNo questionnaire can do this. A few entrepreneurs have devised lengthy computer-scored questionnaires with questions about symptoms that could be present if a vitamin deficiency exists. But such symptoms occur much more frequently in conditions unrelated to nutrition. Even when a deficiency actually exists, the tests don’t provide enough information to discover the cause so that suitable treatment can be recommended. That requires a physical examination and appropriate laboratory tests. Many responsible nutritionists use a computer to help evaluate their clients’ diet. But this is done to make dietary recommendations, such as reducing fat content or increasing fiber content. Supplements are seldom necessary unless the person is unable (or unwilling) to consume an adequate diet.

They Use Anecdotes and Testimonials to Support Their Claims.

Establishing medical truths requires careful and repeated investigation—with well-designed individual endorsementexperiments, not reports of coincidences misperceived as cause-and-effect. That’s why testimonial evidence is forbidden in scientific articles, is usually inadmissible in court, and is not used to evaluate whether or not drugs should be legally marketable. (Imagine what would happen if the FDA decided that clinical trials were too expensive and therefore drug approval would be based on testimonial letters or interviews with a few patients.)

They Claim They Are Being Persecuted by Orthodox Medicine
and That Their Work Is Being Suppressed Because It’s Controversial.

conspirancyThe “conspiracy charge” is an attempt to gain sympathy by portraying the quack as an “underdog.” Quacks typically claim that the American Medical Association is against them because their cures would cut into the incomes that doctors make by keeping people sick. Don’t fall for such nonsense! Reputable physicians are plenty busy. Moreover, many doctors engaged in prepaid health plans, group practice, full-time teaching, and government service receive the same salary whether or not their patients are sick—so keeping their patients healthy reduces their workload, not their income.

Phony Pharmacies

phony pharmacyThere is not a single area of healthcare that has not been scammed by crooks.  Consumers must continually keep their guard up. Because prescription drugs can be costly many people turn to on-line pharmacies who offer huge discounts for what they say is the same medicine but sometimes under a different name.   Again…buyer beware.

ScamWatch is an Australian organization that provides excellent advice.  They offer these tips to avoid wasting your money on offers that are, “Too good to be true.” I have edited their material.  For more and complete information go to http://www.scamwatch.gov.au/content/index.phtml/tag/Scamwatch/

Miracle cure scams?

Miracle cure scams cover a whole range of products and services which can appear to be legitimate snake oil cures allalternative medicine. They cover health treatments for all kinds of medical conditions from cancer and AIDS to arthritis and colds. Miracle cure scams usually promise quick and easy remedies for serious medical conditions.

Miracle cure scams are particularly nasty because they usually increase health and emotional stress, they are costly, and they can be dangerous if they prevent you from seeking expert medical advice. They exploit people’s hopes for improved health and end up causing more problems for people who already have enough to deal with.

Warning signs

  • The treatment claims to be effective against a very wide range of ailments.
  • The miracle cure is suggested after a condition is diagnosed using a questionnaire (often on the internet).
  • The product is sold through unconventional means. For example, it might be sold over the internet, by unqualified individuals, through mail order ads, or on television infomercials.
  • The product relies on some guru figure, or a certain ingredient that is claimed to have mystical properties.
  • There is no scientific evidence to back up the claim that the miracle cure actually works.
  • Miracle cures usually include anonymous testimonials, for example ‘Luke, from

Do your homework

You should seek independent medical advice from your doctor or other qualified health care professional about the miracle cure to see if it is safe and suitable for you. Remember that a legitimate diagnosis cannot be made by someone who is not qualified or has not seen you. Do not rely solely on information you find on the internet.

If you are interested in the product, find out if there are any published medical or research papers to back up the claims. Make sure you know the full cost of the product or service, and if there is a genuine money back guarantee.

Senior Citizens are Targets of Scammers and Quacks

senior scamsAs a senior citizen myself I see the scams and phony offers on a daily basis.  They come by email, snailmail, telephone and internet “News” flashes.  The best advice we can give is this.  If you don’t know the people who are making a claim, dismiss them and seek advice from someone you trust.

Here are some of the top scams that target senior citizens

http://www.ncoa.org/enhance-economic-security/economic-security-Initiative/savvy-saving-seniors/top-10-scams-targeting.html  (again, I have edited the material for the complete report click on the above link)

Financial scams targeting seniors have become so prevalent that they’re now considered “the crime of the 21st century.”  Over 90% of all reported elder abuse is committed by an older person’s own family members, most often their adult children, followed by grandchildren, nieces and nephews, and others.

Financial scams also often go unreported or can be difficult to prosecute, so they’re considered a “low-risk” crime. However, they’re devastating to many older adults and can leave them in a very vulnerable position with little time to recoup their losses.

Some ways to identify scams

Health Care/Medicare/Health Insurance Fraudsenior on phone

Every U.S. citizen or permanent resident over age 65 qualifies for Medicare, so there is rarely any need for a scam artist to research what private health insurance company older people have in order to scam them out of some money.

In these types of scams, perpetrators may pose as a Medicare representative to get older people to give them their personal information, or they will provide bogus services for elderly people at makeshift mobile clinics, then use the personal information they provide to bill Medicare and pocket the money.

Counterfeit Prescription Drugs

Most commonly, counterfeit drug scams operate on the Internet, where seniors increasingly go to find better prices on specialized medications.

The danger is that besides paying money for something that will not help a person’s medical condition, victims may purchase unsafe substances that can inflict even more harm. This scam can be as hard on the body as it is on the wallet.

Funeral & Cemetery Scams

funeral scammerThe FBI warns about two types of funeral and cemetery fraud perpetrated on seniors.

In one approach, scammers read obituaries and call or attend the funeral service of a complete stranger to take advantage of the grieving widow or widower. Claiming the deceased had an outstanding debt with them, scammers will try to extort money from relatives to settle the fake debts.

Another tactic of disreputable funeral homes is to capitalize on family members’ unfamiliarity with the considerable cost of funeral services to add unnecessary charges to the bill.

In one common scam of this type, funeral directors will insist that a casket, usually one of the most expensive parts of funeral services, is necessary even when performing a direct cremation, which can be accomplished with a cardboard casket rather than an expensive display or burial casket.

Fraudulent Anti-Aging Products

In a society bombarded with images of the young and beautiful, it’s not surprising that some older people feel the need to conceal their age in order to participate more fully in social circles and the workplace.

Whether it’s fake Botox like the one in Arizona that netted its distributors (who were convicted and jailed in 2006) $1.5 million in barely a year, or completely bogus homeopathic remedies that do absolutely nothing, there is money in the anti-aging business.

Botox scams are particularly unsettling, as renegade labs creating versions of the real thing may still be working with the root ingredient, botulism neurotoxin, which is one of the most toxic substances known to science. A bad batch can have health consequences far beyond wrinkles or drooping neck muscles.

Telemarketing

Perhaps the most common scheme is when scammers use fake telemarketing calls to prey on older peopsenior scams on phonele, who as a group make twice as many purchases over the phone than the national average.

Examples of telemarketing fraud include:

“The Pigeon Drop”

The con artist tells the individual that he/she has found a large sum of money and is willing to split it if the person will make a “good faith” payment by withdrawing funds from his/her bank account. Often, a second con artist is involved, posing as a lawyer, banker, or some other trustworthy stranger.

“The Fake Accident Ploy”

The con artist gets the victim to wire or send money on the pretext that the person’s child or another relative is in the hospital and needs the money.

“Charity Scams”

Money is solicited for fake charities. This often occurs after natural disasters.

Investment Schemes

investment scammersBecause many seniors find themselves planning for retirement and managing their savings once they finish working, a number of investment schemes have been targeted at seniors looking to safeguard their cash for their later years.

From pyramid schemes like Bernie Madoff’s (which counted a number of senior citizens among its victims) to fables of a Nigerian prince looking for a partner to claim inheritance money to complex financial products that many economists don’t even understand, investment schemes have long been a successful way to take advantage of older people.

Homeowner/Reverse Mortgage Scams

The reverse mortgage scam has mushroomed in recent years. With legitimate reverse mortgages increasing in frequency more than 1,300% between 1999 and 2008, scammers are taking advantage of this new popularity.

As opposed to official refinancing schemes, however, unsecured reverse mortgages can lead property owners to lose their homes when the perpetrators offer money or a free house somewhere else in exchange for the title to the property.

Sweepstakes & Lottery Scams

This simple scam is one that many are familiar with, and it capitalizes on the notion that “there’s no such thing as a free lunch.”

Here, scammers inform their mark that they have won a lottery or sweepstakes of some kind and need to make some sort of payment to unlock the supposed prize. Often, seniors will be sent a check that they can deposit in their bank account, knowing that while it shows up in their account immediately, it will take a few days before the (fake) check is rejected.

During that time, the criminals will quickly collect money for supposed fees or taxes on the prize, which they pocket while the victim has the “prize money” removed from his or her account as soon as the check bounces.

The Grandparent Scam

The Grandparent Scam is so simple and so devious because it uses one of older adults’ most reliablegrandparent scam assets, their hearts.

Scammers will place a call to an older person and when the mark picks up, they will say something along the lines of: “Hi Grandma, do you know who this is?” When the unsuspecting grandparent guesses the name of the grandchild the scammer most sounds like, the scammer has established a fake identity without having done a lick of background research.

Once “in,” the fake grandchild will usually ask for money to solve some unexpected financial problem (overdue rent, payment for car repairs, etc.), to be paid via Western Union or MoneyGram, which don’t always require identification to collect.

At the same time, the scam artist will beg the grandparent “please don’t tell my parents, they would kill me.”

While the sums from such a scam are likely to be in the hundreds, the very fact that no research is needed makes this a scam that can be perpetrated over and over at very little cost to the scammer.

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smaller stillBob Aronson is a 2007 heart transplant recipient, the founder and primary author of the blogs on this site and the founder of Facebook’s over 3,000 member Organ Transplant Initiative group.

Now retired and living in Jacksonville, Florida with his wife Robin he spends his time advocating for patients with end stage diseases and for organ recipients.  He is also active in helping his wife with her art business at art festivals and on her Rockin Robin Prints site on Etsy. 

Bob is a former journalist, Governor’s Communication Director and international communications consultant.

Why You Can’t Get Pain Meds


dea cartoonBy Bob Aronson

This is not my first post on this subject and it will no be the last because Americans with real pain are suffering needlessly.

Chronic pain is real.  I know, I have it and right now thousands of U.S. docs are refusing to prescribe narcotic pain killers not because people don’t need them but rather because federal agencies in their zeal to eliminate “Pill Mills” have frightened physicians.

They’ve told docs they run the risk of being investigated if they can’t prove an absolute need for every opioid prescription they write.  The result is that docs don’t want or need the hassle so many of them are saying, “No” to all requests for pain killers even when they know the requests are legitimate.  It happened to me and it is happening to thousands of others as well.

Federal agencies have gone over the edge on this one.  Their strong-arm tactics aimed at stopping a few unscrupulous physicians may result in some license revocation and brief incarceration while thousands if not millions of chronic pain sufferers are condemned to living with extreme discomfort and excruciating pain.  Have they spent any time thinking through the effect of their intimidation of doctors and pharmacies?   Do they really think that taking drugs away from people who need them will affect the trafficking of prescription meds?

While I understand physician’s reluctance to write prescriptions in the face of pressure from the feds I also think their behavior is as arrogant and irresponsible as the feds.  Physicians take an oath to treat the sick and to do no harm and by refusing to treat patients with with provable, legitimate pain they are violating both promises and risking the physical and mental health of their patients. 

Ever since I published my first blog on the subject I’ve received a constant stream of emails, tweets, Facebook messages and phone calls from people who have been cut off by their physicians.  Just this morning I got this email;

“bob, just read article on crackdown on narc . I have bladder cancer, replaced knee that was screwed up .  Other knee has to be replaced, have torn rotator cup right arm, bulging discs in c5 & c6. so yesterday my doc cut out my Lortabs because of letter from DEA.   Is this right & what do I do?”

What is most bothersome to me is that I don’t really have an answer other than to shop around for a doctor that will prescribe what he/she needs.  Certainly the oncologist should be sympathetic. This is a very serious problem but it is unlikely to be addressed because everyone is afraid…Afraid of being “Soft on narcotics enforcement,” afraid of being hassled, afraid of jail time.  It’s very sad and it is wrong.

Chronic pain is serious.  Millions suffer from it as the result of arthritis, accidents, broken bones, cancer and scores of other reasons.  I am one of them.  I have osteoarthritis and it hurts.  Without narcotic painkillers I would be immobilized.  With them I am functional and feel pretty good.  I don’t get high, I don’t’ abuse them I take them for their stated purpose – pain.

The Drug Enforcement Agency (DEA) has been hunting down “Pill Mill” doctors for years and they should.  It is an unfortunate truth that some real doctors will write prescriptions for almost anyone for an exorbitant fee.  Florida was the prescription drug capitol of the world until not long ago.

DEA is so obsessed with illegal narcotics that they don’t care who gets hurt along the way.  They have now persuaded the Food and Drug Administration to “Recommend” that physicians be more careful in their prescribing of hydrocodone (an opioid also known as Lortab or Vicodin).  The result of the DEA/FDA suggestions, warnings and recommendation is that physicians are just refusing to write prescriptions for narcotic painkillers or, in some cases any controlled substance including Valium. It’s not that docs are afraid of getting arrested, that’s quite unlikely.  They just don’t want the hassle of federal agents bugging them for detailed justification about the prescriptions they are writing for pain killers.

My primary care physician still provides me with the Oxycodone I need but I’m not so sure how long he’ll be able to hold out before he, too, will bend to the pressure from the feds. As the law stands now, a physician cannot call or fax a narcotic painkiller prescription to a pharmacy and those prescriptions are not refillable. To protect himself my primary care physician requires that I see him once a month for a pain evaluation before he writes new script.  Then with prescription in hand I must personally take it to a pharmacist.

I have written two blogs on the subject and there might be more coming.  You can find them at https://bobsnewheart.wordpress.com/2013/07/17/why-your-doc-wont-prescribe-narcotics-no-matter-how-bad-the-pain/     and at   https://bobsnewheart.wordpress.com/2013/12/10/suffering-from-chronic-pain-heres-what-you-need-to-know/

If you want to do something about this talk to your congressman or senator and get them to either deal with the issue legislatively or to put pressure on the FDA and DEA to back off legitimate claims for opioids.

Not Long ago the Boston Globe did a story on this issue.  It is well worth your time to read it.  http://tinyurl.com/l3ahgtc

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Bob Aronson is a 2007 heart transplant recipient, the founder and primary author of the blogs on this site and the founder of Facebook’s over 3,000 member Organ Transplant Initiative group.

Now retired and living in Jacksonville, Florida with his wife Robin he spends his time advocating for patients with end stage diseases and for organ recipients.  He is also active in helping his wife with her art business at art festivals and on her Rockin Robin Prints site on Etsy. 

Bob is a former journalist, Governor’s Communication Director and international communications consultant.

Hospital Errors — The Third Leading Cause of Death in the U.S.


By Bob Aronson

oopsWhen your life has been saved in hospitals several times as mine has,  it is difficult to write a blog that is critical of those institutions but, it is just as difficult to ignore the facts.  As a writer who has made a commitment to provide accurate and timely information to his readers it would be irresponsible to do so. 

This blog is about and for pre and post-transplant patients, their families, donors, donor families, caregivers and friends.  Those of us who are awaiting transplants or who have had them spend an inordinate amount of time in hospitals and clinics.  Our compromised immune systems make us far more susceptible to a myriad of diseases and problems than the average patient and that means we have to be more alert and aware of our surroundings.  It is for that reason that I am posting this information.

 I did not make up the numbers you are about to read.  They are available for everyone to see and to analyze through the links I have provided.  Your comments are not only welcome, they are encouraged.

Never Events, Hospital Acquired Conditions and Sentinel Events

Heart disease and cancer are the number one and two causes of death in the United States.  Number three is medical errors. The very people who are supposed to be experts in saving lives are also responsible for thousands of deaths.

Medical errors in hospitals are killing us faster than chronic lower respiratory diseases, stroke (cerebrovascular diseases), accidents of all kinds, Alzheimer’s disease and diabetes combined.   The very people we trust our lives to – are not only contributing to our deaths they don’t seem to be learning from their mistakes because the problem appears to be getting worse.   While many hospitals claim they are making progress the national numbers don’t show it.  The evidence to the contrary is overwhelming.  And — one cannot help but believe that the problem is even worse than is stated in this posting because there is no system in the U.S. for reporting and tracking medical errors and their results.  Voluntary reporting is spotty and incomplete so we are left with educated guestimates and they are frightening.

In 1999, the Institute of Medicine published the “To Err Is Human” report.  It generated huge front page headlines everywhere by estimating that nearly 100,000 people die every year as a result of hospital errors.  At first there was widespread denial in the medical community but no longer.  The medical profession accepts that number.  The problem is that the number is wrong.

In 2010 another number was announced.  The Office of the U.S. Inspector General for Health and Human Services said that poor hospital care contributed to the deaths of 180,000 patients in Medicare alone in any given year…  Note — they said Medicare alone!  But — that number is wrong, too.  The story is about to get much worse.

A study published in September of 2013 in the Journal of Patient Safety says the numbers may be much higher.  They say that between 210,000 and 440,000 patients die in hospitals each year as the result of preventable errors. Please note that the numbers quoted in the preceding reports only refer to deaths.  None of the numbers I have seen say anything about the number of injuries caused by medical errors.

The new estimates were the result of work by John T. James, who works as a toxicologist at NASA’s Houston, Texas space center.  James also runs a group called Patient Safety America.  http://patientsafetyamerica.com/  James dedicated the site to his 19-year old son, John Alexander James, who he says, “Died as a result of uninformed, careless, and unethical care by cardiologists at a hospital in central Texas in the late summer of 2002.”

propublica logoProPublica an investigative journalism group asked three prominent patient safety researchers to review James’ study and all said his methods and findings were credible. http://www.propublica.org/  The American Hospital Association, though, rejects the number preferring to believe the number of 98,000 deaths from the 1999 report.

What’s the right number?  Nobody knows for sure but we do know it is not getting smaller. As stated earlier there is no standardized national reporting system on medical errors, who is affected and who makes them.

So we’re left with approximations, which are imperfect in part because of inaccuracies in medical records and the fact that a good many of the errors that take place are never reported. Hospitals and physicians have traditionally fought establishing a formal reporting system for fear of prosecution.  Instead they advocate a voluntary reporting system which begs the question, “Who is going to voluntarily admit to committing an error that resulted in a patient’s injury or death.”  I have to believe the number would be quite small.  Admissions of that nature could have extremely negative effects on careers and may even open the door to civil suits or criminal prosecution.  Perhaps I can be persuaded to think otherwise but I’ve seen nothing so far to indicate any voluntary system can work.

While the lay public calls them medical mistakes or errors the medical community has chosen to use different terminology.  They refer to their errors as “Never Events” or Hospital Acquired Conditions (HACs)    Never events are never supposed to happen – but they do and the onus is clearly on hospitals to do something about them.  The Government found that one way to force hospitals to deal with these problems is to refuse payment so for several years now Medicaid and Medicare do not pay for any Hospital Acquired Condition.

When I was a communications consultant I specialized in health care so I spent a great deal of time working inoops oops and oops and around hospitals and clinics.  The great majority of them take the issue of patient safety very seriously and have implemented a multitude of actions to address the problem.  They all have preventive programs and systems on what to do when there is an error.  Most hospitals conduct a “Root Cause Analysis” every time there is a significant error so they can be sure the same error doesn’t happen again. They are working on the problem but patients owe it to themselves to always be alert and to question everything.  Hospitals need to know that we are watching very carefully and that we will report what we see and experience.

Here is a list of HACs or Never Events as prepared by the National Quality Forum (NQF).

Table. Never Events or Hospital Acquired Conditions
Surgical events
Surgery or other invasive procedure performed on the wrong body part
Surgery or other invasive procedure performed on the wrong patient
Wrong surgical or other invasive procedure performed on a patient
Unintended retention of a foreign object in a patient after surgery or other procedure
Intraoperative or immediately postoperative/post procedure death in an American Society of Anesthesiologists Class I patient
Product or device events
Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the health care setting
Patient death or serious injury associated with the use or function of a device in patient care, in which the device is used for functions other than as intended
Patient death or serious injury associated with intravascular air embolism that occurs while being cared for in a health care setting
Patient protection events
Discharge or release of a patient/resident of any age, who is unable to make decisions, to other than an authorized person
Patient death or serious disability associated with patient elopement (disappearance)
Patient suicide, attempted suicide, or self-harm resulting in serious disability, while being cared for in a health care facility
Care management events
Patient death or serious injury associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration)
Patient death or serious injury associated with unsafe administration of blood products
Maternal death or serious injury associated with labor or delivery in a low-risk pregnancy while being cared for in a health care setting
Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy
Artificial insemination with the wrong donor sperm or wrong egg
Patient death or serious injury associated with a fall while being cared for in a health care setting
Any stage 3, stage 4, or unstageable pressure ulcers acquired after admission/presentation to a health care facility
Patient death or serious disability resulting from the irretrievable loss of an irreplaceable biological specimen
Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results
Environmental events
Patient or staff death or serious disability associated with an electric shock in the course of a patient care process in a health care setting
Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains no gas, the wrong gas, or is contaminated by toxic substances
Patient or staff death or serious injury associated with a burn incurred from any source in the course of a patient care process in a health care setting
Patient death or serious injury associated with the use of restraints or bedrails while being cared for in a health care setting
Radiologic events
Death or serious injury of a patient or staff associated with introduction of a metallic object into the MRI area
Criminal events
Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider
Abduction of a patient/resident of any age
Sexual abuse/assault on a patient within or on the grounds of a health care setting
Death or significant injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of a health care setting

 Real Life Examples of Medical Mistakes

  1. Wrong Heart and Lung Transplant.  One of the most tragic medical blunders ever took place at Duke University medical center in 2003, when surgeons transplanted a heart lung combination with the wrong blood type into 17-year-old Jesica Santillan.  Her body began to shut down almost immediately. The hospital somehow secured a second and proper matched heart lung combination for Jessica but it was too late and she died.  Dr. James Jaggers accepted responsibility for the tragic mistake, and Duke along with most other hospitals now have systems that require double checking the blood and tissue matches for transplants.
  1. Souvenir of surgery.  In the year 2000 49 year old Donald Church had an abdominal tumor removed at the U of Washington Medical center in Seattle. While he left the hospital without the tumor, he had something that he didn’t have on admission — a 13-inch-long retractor had been left in Church’s abdomen by mistake. To make matters worse it was a repeat performance for the hospital, four other such occurrences had been documented there between 1997 and 2000. Fortunately, surgeons were able to remove the instrument but also agreed to pay Church nearly $100,000.
  1. Healthy kidney removed.  Park Nicollet Methodist Hospital in Minnesota’s twin cities was the site of the next never event.  A man was admitted to have one of his kidneys removed due to a cancerous tumor.  Surgeons did just that but upon a post-surgical examination of the removed kidney they found no malignancy.  That’s when they discovered they had removed the wrong one.  We can’t report further because the family involved requested anonymity but Park Nicollet publicly admitted the error.

What Patients Can Do

A CNN report suggests that many medical errors could be prevented if patients were more aggressive about consequencesmaking sure their health care providers are more focused on what they are doing.

The cable network developed this list of what they call “10 Shocking Medical Mistakes and Ways to Not Become a Victim.

1. Mistake: Treating the wrong patient
Cause: Hospital staff fails to verify a patient’s identity.
Consequences: Patients with similar names are confused.
Prevention: Before every procedure in the hospital, make sure the staff checks your entire name, date of birth and barcode on your wrist band.

2. Mistake: Surgical souvenirs
Cause: Surgical staff miscounts (or fails to count) equipment used inside a patient during an operation.
Consequences: Tools get left inside the body.
Prevention: If you have unexpected pain, fever or swelling after surgery, ask if you might have a surgical instrument inside you.

3. Mistake: Lost patients
Cause
: Patients with dementia are sometimes prone to wandering.
Consequences: Patients may become trapped while wandering and die from hypothermia or dehydration.
Prevention: If your loved one sometimes wanders, consider a GPS tracking bracelet.

4. Mistake: Fake doctors
Cause: Con artists pretend to be doctors.
Consequences: Medical treatments backfire. Instead of getting better, patients get sicker.
Prevention: Confirm online that your physician is licensed.

5. Mistake: The ER waiting game
Cause: Emergency rooms get backed up when overcrowded hospitals don’t have enough beds.
Consequences: Patients get sicker while waiting for care.
Prevention: Doctors listen to other doctors, so on your way to the hospital call your physician and ask them to call the emergency room.
6. Mistake: Air bubbles in blood
Cause: The hole in a patient’s chest isn’t sealed airtight after a chest tube is removed.
Consequences: Air bubbles get sucked into the wound and cut off blood supply to the patient’s lungs, heart, kidneys and brain. Left uncorrected the patient dies.
Prevention: If you have a central line tube in you, ask how you should be positioned when the line comes out.

7. Mistake: Operating on the wrong body part
Cause: A patient’s chart is incorrect, or a surgeon misreads it, or surgical draping obscures marks that denote the correct side of the operation.
Consequences: The surgeon cuts into the wrong side of a patient’s body.
Prevention: Just before surgery, make sure you reaffirm with the nurse and the surgeon the correct body part and side of your operation.

8. Mistake: Infection infestation
Cause: Doctors and nurses don’t wash their hands.
Consequences: Patients can die from infections spread by hospital workers.
Prevention: It may be uncomfortable to ask, but make sure doctors and nurses wash their hands before they touch you, even if they’re wearing gloves.

9. Mistake: Lookalike tubes
Cause: A chest tube and a feeding tube can look a lot alike.
Consequences: Medicine meant for the stomach goes into the chest.
Prevention: When you have tubes in you, ask the staff to trace every tube back to the point of origin so the right medicine goes to the right place.

10. Mistake: Waking up during surgery
Cause: An under-dose of anesthesia.
Consequences: The brain stays awake while the muscles stay frozen. Most patients aren’t in any pain but some feel every poke, prod and cut.
Prevention: When you schedule surgery, ask your surgeon if you need to be put asleep or if a local anesthetic might work just as well.

There are other steps you can take to protect yourself besides those offered by CNN.  For example:

Demand a hand-wash.   While hospitals try to be germ free it is hard when almost everyone who enters the building is sick.  It is a well-known fact that the best thing people can do to protect themselves from disease is frequent hand washing.  The potential for contamination is everywhere so you are well within your rights to ask personnel to wash their hands before touching you.  And…by the way, wash your hands frequently too.

Make sure your room is clean. Usually hospital rooms are thoroughly washed between patients but not as thoroughly if you are going to be there for a while.   If you are concerned with the state of your room ask for certain areas or all of it to be disinfected.  Transplant recipients in particular must be sure they are in as germ free an environment as possible.  Certainly if hospitalized they should always wear a face mask to protect themselves.  And, do your best to stay out of crowded areas like elevators.  If you must enter a crowded room, wear a face mask. All hospitals have them you just have to ask for one…

To be even more specific though, Patient Safety America suggestions these you do the following to stay safe http://patientsafetyamerica.com/truth-about-healthcare/

1. The single most important way you can help to prevent errors is to be an active member of your health care team.

That means taking part in every decision about your health care. Research shows that patients who are more involved with their care tend to get better results. Here are some specific tips, based on the latest scientific evidence about what works best.

Medicines

2. Make sure that all of your doctors know about everything you are taking. This includes prescription and over-the-counter medicines, and dietary supplements such as vitamins and herbs.

At least once a year, bring all of your medicines and supplements with you to your doctor. “Brown bagging” your medicines can help you and your doctor talk about them and find out if there are any problems. It can also help your doctor keep your records up to date, which can help you get better quality care.

3. Make sure your doctor knows about any allergies and adverse reactions you have had to medicines.

This can help you avoid getting a medicine that can harm you.

4. When your doctor writes you a prescription, make sure you can read it.

If you can’t read your doctor’s handwriting, your pharmacist might not be able to either.

5. Ask for information about your medicines in terms you can understand—both when your medicines are prescribed and when you receive them.

  • What is the medicine for?
  • How am I supposed to take it, and for how long?
  • What side effects are likely? What do I do if they occur?
  • Is this medicine safe to take with other medicines or dietary supplements I am taking?
  • What food, drink, or activities should I avoid while taking this medicine?

6. When you pick up your medicine from the pharmacy, ask: Is this the medicine that my doctor prescribed?

A study by the Massachusetts College of Pharmacy and Allied Health Sciences found that 88 percent of medicine errors involved the wrong drug or the wrong dose.

7. If you have any questions about the directions on your medicine labels, ask.

Medicine labels can be hard to understand. For example, ask if “four doses daily” means taking a dose every 6 hours around the clock or just during regular waking hours.

8. Ask your pharmacist for the best device to measure your liquid medicine. Also, ask questions if you’re not sure how to use it.

Research shows that many people do not understand the right way to measure liquid medicines. For example, many use household teaspoons, which often do not hold a true teaspoon of liquid. Special devices, like marked syringes, help people to measure the right dose. Being told how to use the devices helps even more.

9. Ask for written information about the side effects your medicine could cause.

If you know what might happen, you will be better prepared if it does—or, if something unexpected happens instead. That way, you can report the problem right away and get help before it gets worse. A study found that written information about medicines can help patients recognize problem side effects and then give that information to their doctor or pharmacist.

Hospital Stays

10. If you have a choice, choose a hospital at which many patients have the procedure or surgery you need.

Research shows that patients tend to have better results when they are treated in hospitals that have a great deal of experience with their condition.

11. If you are in a hospital, consider asking all health care workers who have direct contact with you whether they have washed their hands.

Hand washing is an important way to prevent the spread of infections in hospitals. Yet, it is not done regularly or thoroughly enough. A recent study found that when patients checked whether health care workers washed their hands, the workers washed their hands more often and used more soap.

12. When you are being discharged from the hospital, ask your doctor to explain the treatment plan you will use at home.

This includes learning about your medicines and finding out when you can get back to your regular activities. Research shows that at discharge time, doctors think their patients understand more than they really do about what they should or should not do when they return home.

Surgery

13. If you are having surgery, make sure that you, your doctor, and your surgeon all agree and are clear on exactly what will be done.

Doing surgery at the wrong site (for example, operating on the left knee instead of the right) is rare. But even once is too often. The good news is that wrong-site surgery is 100 percent preventable. The American Academy of Orthopedic Surgeons urges its members to sign their initials directly on the site to be operated on before the surgery.

Other Steps You Can Take

14. Speak up if you have questions or concerns.

You have a right to question anyone who is involved with your care.

15. Make sure that someone, such as your personal doctor, is in charge of your care.

This is especially important if you have many health problems or are in a hospital.

16. Make sure that all health professionals involved in your care have important health information about you.

Do not assume that everyone knows everything they need to.

17. Ask a family member or friend to be there with you and to be your advocate (someone who can help get things done and speak up for you if you can’t).

Even if you think you don’t need help now, you might need it later.

18. Know that “more” is not always better.

It is a good idea to find out why a test or treatment is needed and how it can help you. You could be better off without it.

19. If you have a test, don’t assume that no news is good news.

Ask about the results.

20. Learn about your condition and treatments by asking your doctor and nurse and by using other reliable sources.

You may ask yourself upon reading all of this what the U.S. Food and Drug Administration (FDA) is doing to make hospitals safer.  Well, they can’t be in every hospital all the time to watch everything and…that’s not their role.  The FDA is probably not doing enough to protect us, there’s no way you can satisfy everyone but they are doing a few things that could make a huge difference.  One of which is to eliminate drug name confusion.

To minimize confusion between drug names that look or sound alike, the FDA reviews about 300 drug names a year before they are marketed. “About one-third of the names that drug companies propose are rejected,” says Phillips. The agency tests drug names with the help of about 120 FDA health professionals who volunteer to simulate real-life drug order situations. “FDA also created a computerized program that assists in detecting similar names and that will help take a more scientific approach to comparing names,” Phillips says.

After drugs are approved, the FDA tracks reports of errors due to drug name confusion and spreads the word to health professionals, along with recommendations for avoiding future problems. For example, the FDA has reported errors involving the inadvertent administration of methadone, a drug used to treat opiate dependence, rather than the intended Metadate ER (methylphenidate) for the treatment of attention-deficit/hyperactivity disorder (ADHD). One report involved the death of an 8-year-old boy after a possible medication error at the dispensing pharmacy. The child, who was being treated for ADHD, was found dead at home. Methadone substitution was the suspected cause of death. Some FDA recommendations regarding drug name confusion have encouraged pharmacists to separate similar drug products on pharmacy shelves and have encouraged physicians to indicate both brand and generic drug names on prescription orders, as well as what the drug is intended to treat.

The last time the FDA changed a drug name after it was approved was in 2004 when the cholesterol-lowering medicine Altocor was being confused with the cholesterol-lowering medicine Advicor. Now Altocor is called Altoprev, and the agency hasn’t received reports of errors since the name change. Other examples of drug name confusion reported to the FDA include:

  • Serzone (nefazodone) for depression and Seroquel (quetiapine) for schizophrenia
  • Lamictal (lamotrigine) for epilepsy, Lamisil (terbinafine) for nail infections, Ludiomil (maprotiline) for depression, and Lomotil (diphenoxylate) for diarrhea
  • Taxotere (docetaxel) and Taxol (paclitaxel), both for chemotherapy
  • Zantac (ranitidine) for heartburn, Zyrtec (cetirizine) for allergies, and Zyprexa (olanzapine) for mental conditions
  • Celebrex (celecoxib) for arthritis and Celexa (citalopram) for depression.

For more information on the FDA and what they are doing click on this link http://www.fda.gov/

The bottom line on medical errors is activist patients.  Don’t sit by quietly when you perceive something to be wrong with your care or the care of someone near and dear to you.  Speak up, tell someone about your concerns.  Every city and state has some sort of health department so if you see something wrong speak up and tell the appropriate authority starting with the hospital.

Most importantly, though, be aggressive and knowledgeable about your own health care.  Don’t be afraid to ask for second opinions, to question physicians, nurses and other practitioners.  Force your health care provider to speak to you in plain English and if you don’t understand ask for clarification.  Hospital personnel work for you so they have a responsibility to respond to your concerns in as thorough and clear a manner as possible. The only way hospitals will really change for the better is for citizens, patients like you and me to speak up and let them know we know.

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bob half of bob and jay photoBob Aronson is a 2007 heart transplant recipient, the founder and primary author of the blogs on this site and the founder of Facebook’s over 3,000 member Organ Transplant Initiative group.

Now retired and living in Jacksonville, Florida with his wife Robin he spends his time advocating for patients with end stage diseases and for organ recipients.  He is also active in helping his wife with her art business at art festivals and on her Rockin Robin Prints site on Etsy. 

Bob is a former journalist, Governor’s Communication Director and international communications consultant.

Prescribing Abilify — Are Physicians Careful Enough?


By Bob Aronson

final cartoonThis blog is a wake-up call for those who take anti-depressants.  It is an attempt by Bob’s Newheart to draw attention to the drugs, the prescription process and some of the side effects they present.  We will focus in particular on the Bristol Meyers Squibb antipsychotic, Abilify.

This post does not pretend to offer a scientific evaluation of the drug.  We have neither the expertise nor the facilities to accomplish that.  Through research, though, we can offer readers some selected information upon which they can make their own judgments.  Specifically we looked into what the drug is intended to do, what it does, what unintended consequences have resulted and, of course, the profitability of the medication.

I was drawn to this subject because I have taken Abilify and suffered serious side effects.  I will detail them and offer other examples both scientific and personal later in this post.

Abilify is becoming a very commonly prescribed anti-depressant.  While there are many possible side effects this warning from the U.S. Food and Drug Administration (FDA) stands out.

FDA WARNINGS: INCREASED MORTALITY IN ELDERLY

PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and

SUICIDALITY AND ANTIDEPRESSANT DRUGS

See full prescribing information for complete boxed warning.

Elderly patients with dementia-related psychosis treated with

Antipsychotic drugs are at an increased risk of death. ABILIFY is

not approved for the treatment of patients with dementia-related

psychosis. (5.1)

Children, adolescents, and young adults taking antidepressants for

Major Depressive Disorder (MDD) and other psychiatric disorders

are at increased risk of suicidal thinking and behavior. (5.2)

Not only does Abilify cause concern for elderly patients, it should be a cause of concern for all patients for many reasons including one that affected me, Tardive Dyskinesia.  Remember that term…we’ll be returning to it, but first I want to re-visit the subject of depression and what it is.

Many awaiting organ transplants and recipients as well suffer from serious bouts of depression.  They often will attribute their sunken feelings with being told that they have an end-stage disease.

Strangely, many patients who have received the “gift of life” also feel depressed and some even become suicidal.  Many believe they are depressed due to guilt.  Guilt caused by the belief that they received organs ahead of patients who were sicker and more deserving.

To the lay person the explanations given by pre and post-transplant patients make sense but medical science and research has told us for a very long time that the moods they describe may be the result of chemical imbalances.  Well, that may not be true.  Here’s what the Harvard Medical school has to say about depression and what it is.

cartoon...depression“Research suggests that depression doesn’t spring from simply having too much or too little of certain brain chemicals. Rather, depression has many possible causes, including faulty mood regulation by the brain, genetic vulnerability, stressful life events, medications, and medical problems. It’s believed that several of these forces interact to bring on depression.

To be sure, chemicals are involved in this process, but it is not a simple matter of one chemical being too low and another too high. Rather, many chemicals are involved, working both inside and outside nerve cells. There are millions, even billions, of chemical reactions that make up the dynamic system that is responsible for your mood, perceptions, and how you experience life.

With this level of complexity, you can see how two people might have similar symptoms of depression, but the problem on the inside, and therefore what treatments will work best, may be entirely different.” You can read all the details of the Harvard explanation here http://www.health.harvard.edu/newsweek/what-causes-depression.htm

If you read between the lines of the Harvard explanation you can quickly come to the conclusion that physicians who treat depression are involved in educated guesswork as they try to find the right drugs to relieve depression symptoms.

I have been treated for depression for years and whether the treatment was offered by my family physician or by a licensed, board certified Psychiatrist the approach is the same.  They ask some key questions about lifestyle, what’s bothering you, how you feel and why and then say, “We’ll try a few things to see what works.  Let’s get you started on (drug).  It takes from 2 to 5 weeks for an effect to be felt but call me in a couple of weeks to let me know how you are doing.”

Obviously physicians have more knowledge about things medical than we do but when it comes to depression it can be a big guessing game.  There are scores of drugs that can be used depending on your symptoms but don’t be surprised if the most highly skilled psychiatrist armed with the best questions has difficulty deciding what’s best for you.  Even the famed Mayo Clinic says,

“Antidepressants are a popular treatment choice for those with moderate or severe depression. Although antidepressants may not cure depression, they can reduce your symptoms. The first antidepressant you try may work fine. But if it doesn’t relieve your symptoms, or it causes side effects that bother you, you may need to try another.

But don’t give up. A number of antidepressants are available, and chances are you’ll be able to find one that works well for you.”

So when you begin taking an anti- depressant you should not expect immediate positive results because you may get no relief at all — or worse yet, you could suffer some very negative side effects.

There are several different types of anti-depressants and they, like all drugs, bring with them side effects of which can be quite serious.  The problem is that because no two people have the same physical and mental make-up it is impossible to predict who will react negatively to a medication, who will react positively and who will have no reaction at all.  You can find more information about the types of drugs and their side effects here.  http://www.helpguide.org/mental/types_of_antidepressants.htm.

And that leads us to our reason for writing this blog.  Abilify and drugs like it can help a person feel wonderful abilifyor make you absolutely miserable and cause permanent damage…  I took Abilify and had a horrible reaction to it as did others I know.

Before I go on I feel compelled to point out that my case and other individual cases do not constitute medical evidence.  Individual cases are classified as anecdotal and while they may sound convincing are not considered medical proof so I will do my best to combine anecdotal and real medical evidence.

You should know, too, what anti-psychotic drugs like Abilify are and what they do.

According to Medicine Net dot com:

http://www.medicinenet.com/script/main/art.asp?articlekey=26299 The first antipsychotic medications were introduced in the 1950s. Antipsychotic medications have helped many patients with psychosis lead a more normal and fulfilling life by alleviating such symptoms as hallucinations, both visual and auditory, and paranoid thoughts. However, the early antipsychotic medications often have unpleasant side effects, such as muscle stiffness, tremor, and abnormal movements, leading researchers to continue their search for better drugs.

“The 1990s saw the development of several new drugs for schizophrenia, called “atypical antipsychotics.” Because they have fewer side effects than the older drugs, today they are often used as a first-line treatment. The first atypical antipsychotic, clozapine (Clozaril), was introduced in the United States in 1990. In clinical trials, this medication was found to be more effective than conventional or “typical” antipsychotic medications in individuals with treatment-resistant schizophrenia (schizophrenia that has not responded to other drugs), and the risk of tardive dyskinesia (a movement disorder) was lower. However, because of the potential side effect of a serious blood disorder–agranulocytosis (loss of the white blood cells that fight infection)-patients who are on clozapine must have a blood test every 1 or 2 weeks. The inconvenience and cost of blood tests and the medication itself have made maintenance on clozapine difficult for many people. Clozapine, however, continues to be the drug of choice for treatment-resistant schizophrenia patients.

Several other atypical antipsychotics have been developed since clozapine was introduced, they are risperidone (Risperdal), aripiprazole (Abilify),  olanzapine (Zyprexa), quetiapine (Seroquel), and ziprasidone (Geodon). Each has a unique side effect profile, but in general, these medications are better tolerated than the earlier drugs. Click on the links above to each drug for more information about side effects.

All these medications have their place in the treatment of schizophrenia, and doctors will choose among them. They will consider the person’s symptoms, age, weight, and personal and family medication history”.

Now let’s get back to those side effects I alluded to earlier in this post.

Patients who take Abilify and some other prescription drugs can develop Tardive Dyskinesia which presents as involuntary, repetitive tic-like movements primarily in the facial muscles or (less commonly) the limbs, fingers and toes. The hips and torso may also be affected. 

Symptoms of tardive dyskinesia can develop and persist long after use of the medication causing the disorder has been discontinued. Tardive dyskinesia can appear similar to other types of disorders, most notably Tourette’s syndrome and can become a permanent medical condition.  

While taking Abilify I developed Tardive Dyskinesia and fortunately quit taking it in time to prevent the affliction from becoming permanent.  The above description does not do justice to it.  When it affected me it was accompanied by confusion, agitation and uncontrollable and very visible tremors around my lower jaw to the point where my teeth could be heard hitting each other despite major efforts on my part to prevent the occurrence.  Furthermore the drug caused tremors in my hands and hips which disappeared once I quit taking the medication.  I felt as though I was disassembling.

Not all patients are affected by dyskinesia.  Some have experienced other side effects.  One friend who we will call “Bill” wrote the following.

I started off on the lowest dose, 2 mg but I felt as though I was going to crawl out of my skin so I cut the dose in half on my own.

While I did not have the movement issues consistent with Tardive dyskinesia.  I did experience a terrible feeling of anxiety and depression unlike any I had experienced in the past.  I can describe the feeling in no other way than to say I felt like my mind was coming unglued.

My physician explained that he thought the dose was too low so we increased it again to 2mg which is a very lose dose but — things got much worse.   I could no longer handle the effects on my mind and body and stopped taking it.  The effects went away the next day.

Perhaps Abilify works for some but for me it was disastrous. Good thing I have a medical background and sense enough to stop taking it. Too often the docs give you something like this and say see me in 2 months, or longer.”

It is important to note here that the drug label clearly says that no one should just stop taking Abilify.  To discontinue use one should taper off slowly under a physician’s watchful eye.  Unfortunately as with Bill, he was unable to see a physician and the effects were so bad he felt compelled to take action himself.

Two stories do not constitute medical evidence but a CNN report says,

“The growing use of a popular drug in the long-term treatment of bipolar disorder is based largely on a single, flawed clinical trial that may be steering doctors and patients away from drugs with a more established track record.”

The CNN expert who studied the studies that got Abilify FDA approval said, “

“The medical research does not appear to justify the widespread use of Abilify for maintenance therapy,” says psychiatrist Alexander C. Tsai, M.D., one of the lead authors of the review and a visiting researcher at Harvard University.” We failed to find sufficient data to support its use.” http://www.cnn.com/2011/HEALTH/05/03/abilify.use.questions/

Bristol Meyers Squibb is the American manufacturer of the drug.  They spend a lot of money on advertising and it pays off.  Abilify was the second-biggest selling drug in their portfolio In 2011 when the antipsychotic generated nearly $2.8 billion in sales, or roughly 13 percent of net sales second only to the $7.1 Billion generated by Plavix.

According to Pharmalot http://www.pharmalive.com/feds-subpoena-bristol-myers-over-abilify-marketing

In September 2007, Bristol-Myers Squibb agreed to settle charges of giving kickbacks to docs and overcharging the government. Among the infractions alleged by the federal and state governments was off-label promotion of its Abilify antipsychotic, and the drugmaker subsequently paid $515 million and signed a five-year corporate integrity agreement.

At the time of the settlement, Bristol-Myers was charged with directing its sales force to call on child psychiatrists and other pediatric specialists, and reps then urged physicians and other health care providers to prescribe Abilify for children. The drug maker also was charged with creating a specialized long=term care sales force that called almost exclusively on nursing homes, where dementia-related psychosis is far more prevalent than schizophrenia or bipolar disorder (back story and the CIA).

The bottom line is this.  Abilify can help.  The problem is that medical science cannot say with certainty who it will help, what conditions it will alleviate and most importantly when and if the side effects will show up.  All they can say is Abilify MIGHT help some patients.

If your physician prescribes Abilify for you it is imperative that you have access to him/her while you are taking it so that if you are negatively affected you can be directed on how best to quit taking it without causing further damage.

One has to wonder about the impact of prescription drug advertising.  It is obviously done to get patients to put pressure on physicians to prescribe drugs that cannot be bought over the counter.  One also has to wonder about the practice of providing physicians with samples to pass out to patients and finally — one has to wonder what’s in it for the physician who prescribes the meds.  Lots of questions — not too many answers.

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scooter half size for wordpressBob Aronson is a 2007 heart transplant recipient, the founder and primary author of the blogs on this site and the founder of Facebook’s over 3,000 member Organ Transplant Initiative group.

Now retired and living in Jacksonville, Florida with his wife Robin he spends his time advocating for patients with end stage diseases and for organ recipients.  He is also active in helping his wife with her art business at art festivals and on her Rockin Robin Prints site on Etsy. 

Bob is a former journalist, Governor’s Communication Director and international communications consultant.

Got Chronic Pain & Can’t Get Pain Meds? Here’s What You Need to Know


By Bob Aronson

pain from the spouse pount of view

Chronic pain is of major interest to me because I suffer from it and have been denied treatment as well.  I have an established record as a sufferer and one who has tried a wide range of alternatives to the “controlled substances” the medical profession is so reluctant to prescribe.  I understand that we have a serious addiction problem in this country and that a very tiny minority of physicians over-prescribe controlled substances like Vicodin and Oxycodone.

I also understand that the U.S. Food and Drug Administration  (FDA) and the Drug Enforcement Administration (DEA) are cracking down hard on this activity but in the process are intimidating the entire medical profession in order to rout out the few who recklessly dispense narcotics to nearly anyone who wants them.  I know from first-hand experience and from the testimony of others that many physicians are so intimidated they refuse to prescribe pain killing narcotics to anyone.  I get all that and outline it in detail in this post.

Conversely, I believe that physicians have a unique opportunity and even an ethical responsibility to act as patient advocates rather than to retreat under fire and refuse treatment to those with legitimate pain issues.  The oath that says, Hipocrates“First, do no harm,” is broken any time relief is available but refused not because there is evidence that the patient is being dishonest but because the physician fears investigation. That to me is unconscionable and a terrible disservice to patients. Too many doctors at too many institutions have been intimidated by the threat of investigation and it is patients in pain who suffer as a result.

The publication, Scientific American  says this of chronic pain:  “Anyone living with chronic pain knows that it amounts to much more than an unpleasant bodily sensation. Fuzzy thinking, faulty memory, anxiety and depression chronic pain graphicoften accompany long-term pain, suggesting that the condition is more of a whole-brain disorder than simply pain signaling gone haywire. New research from Northwestern University reveals a possible cause: an impaired hippocampus, a region critical for learning, memory and emotional processing (you can read more by clicking on this link) http://www.scientificamerican.com/article.cfm?id=how-chronic-pain-affects-memory-mood

While chronic pain is a recognized medical condition that often can only be treated with controlled substances it is becoming more and more difficult to find physicians who will prescribe them.  The reasons? Abuse, misuse, suicides, crime, greed and among physicians fear and intimidation.

On October 24, 2013 this headline greeted readers when they picked up their morning paper; FDA Crackdowns on Painkiller DrugsThe move was prompted by one drug in particular — Hydrocodone otherwise known as Vicodin the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S.

vicodinIn a major policy shift, the agency said in an online notice that hydrocodone containing drugs should be subject to the same restrictions as other narcotic drugs like oxycodone and morphine.  What this means is that the regulating agencies first made it difficult to get the major pain killers and now are restricting lesser ones as well.  The question is where will it stop and how will chronic pain sufferers be affected? History tells us that actions like this will cause fewer prescriptions to be written but that many patients who legitimately need these drugs will be caught up in the dragnet and lose their relief.

The latest move comes more than a decade after the Drug Enforcement Administration first asked the FDA to reclassify hydrocodone so that it would be subject to the same restrictions as other addictive painkilling drugs.

.

Florida is or was at the epicenter of an explosion in narcotics prescriptions written by unscrupulous physicians who provided narcotics to almost anyone for exorbitant prices.  Pharmacies were caught playing the game with these docs and while the action by the feds reduced the number of pill mills, it also caused great agony for those who suffer from chronic pain and could no longer get relief. (http://www.firstcoastnews.com/news/health/article/333761/10/Pill-mill-crackdowns-hurting-those-in-real-pain

I will return to the legal and ethical conundrums faced by physicians and pharmacists shortly but let’s step back for just a moment or two to look at the human side.  The millions of people who suffer from chronic pain and who depend on controlled substances to provide them with some semblance of human life…and I’m one of them.

American pain foundationThe American Pain Foundation says that chronic pain is a complex condition that affects almost 50 million Americans.  Even after decades of research, chronic pain remains poorly understood and hard to control.

Chronic pain can be severe, so severe it has driven some to take their own lives.  It is a major problem and often even the most potent of pain killers has only a minimal effect.  Here’s how two patients describe their daily battle with chronic pain.

“It feels as though someone has stuck a white hot poker into the bones at the top of my spine and the base of my neck.  The pain radiates to both shoulders and down my back. I cannot stand without help and cannot sit in any one position for very long.  Turning my head is too painful to even contemplate.  Like a master torturer the pain seems to know just where to attack next to make me confess and confess I would – to anything at all if it would just go away for a few minutes.”  That’s the testimony of a Frank R. a Michigan man suffering from chronic pain brought on by osteoarthritis.

In the state of Virginia Mary T. says this. “It is my lower back and both of my legs.  The pain is not intense it is beyond that and it is unrelenting.   Sometimes I am so tired out from battling pain all night I will just sit and cry but the pain monster takes no pity.  I cannot walk without support, so now I have a cane which helps me get around but the pain doesn’t want me to walk and has begun attacking the arm and hand I use to hold the cane.  Death would be a relief; I can’t go on living like this.”

Frank and Mary are fairly typical chronic pain sufferers.  Both take narcotics to manage the pain neither gets much relief anymore because of building high tolerances for opiates.  Both have tried almost everything modern medicine has to offer and narcotics are all that is left to help them but because tolerances go up, one is forced to take more and more of the narcotic until finally the pain subsides – it doesn’t go away it just backs off for a while but the massive doses of narcotics can leave the patient in an almost Zombie like state, unable to concentrate or focus on any task and sleepy, so sleepy that some days patients don’t bother to get out of bed.  The result is that while the pain may be minimized so is the patient’s quality of life.

A survey by the American Academy of Pain Medicine found that even comprehensive treatment with painkilling prescription drugs helps, on average, only about 58% of people with chronic pain.  

What causes chronic pain, and what can you do about it?

Some cases of chronic pain can be traced to a specific injury that has long since healed. Other cases have no apparent cause — no prior injury and an absence of underlying tissue damage. However, many cases of chronic pain are related to these conditions:

  • Low back pain
  • Arthritis, especially osteoarthritis
  • Headache
  • Multiple sclerosis
  • Fibromyalgia
  • Shingles
  • Nerve damage (neuropathy)

Treating your underlying condition is important. But often that does not resolve the pain issue.  Increasingly, doctors consider chronic pain a condition of its own, requiring pain treatment that addresses the patient’s physical and psychological health.

Chronic pain can leave a person almost unable to function and the medical profession doesn’t seem to know what to do about it because they are getting mixed messages from state and federal governments. 

On one hand government says, ”Treat the patient, give them what they need to manage pain,” and on the other the Feds in particular are saying, “There are too many greedy quacks out there handing out narcotics like Pez dispensers and it has to stop.”  Here’s why:

centers for disease controlEarlier this year the Centers for Disease Control and Prevention reported that prescription painkiller overdose deaths among women increased about fivefold between 1999 and 2010. Among men, such deaths rose about 3.5-fold. The rise in both death rates is closely tied to a boom in the overall use of prescribed painkillers. 

The result is that many major medical centers are playing it safe and prescribing narcotics for short term relief following surgeries and a few other specific situations like terminal cancer victims but otherwise are telling patients to see their primary physician for pain relief.  The reason cited by many medical centers is that the laws are incredibly complex and therefore vague. For example, here’s just a short section of New York law (you can read all of it herehttp://www.medscape.com/resource/opioid/opioid-newyork

License. Only practitioners who are properly licensed and registered may issue a prescription for a controlled substance. Section 80.64 contains the full information about who may issue controlled substances.

Purpose of a Prescription. A prescription is the instrument to legalize an ultimate user’s possession of a controlled substance. To be effective then, a controlled substance prescription should be issued for legitimate medical purposes only. Section 80.65 contains the full text.

Initial and Corresponding Responsibilities: Prescriber and Pharmacist. The responsibility for the proper prescribing and dispensing of controlled substances is on the physician, dentist, podiatrist, veterinarian, or other authorized practitioner, but a corresponding liability rests with the pharmacist who fills the prescription.

A practitioner cannot supply prescriptions to maintain an addict or habitual user of controlled substances. There are some exceptions and practitioners should read the New York law very carefully. An order purporting to be a prescription issued to an addict or habitual user of controlled substances not in the course of professional treatment but for the purpose of providing the user with narcotics or other controlled substances sufficient to keep him or her comfortable by maintaining his or her customary use is not a prescription within the meaning of New York law.

It is no wonder physicians are reluctant to prescribe opiates, they fear losing their licenses.  In the preceding paragraph physicians are told they cannot provide controlled substances to addicts or habitual users but many people with chronic pain ARE habitual users and they may be addicted as well, and the New York law could easily be interpreted to read that prescribing controlled substances to chronic pain sufferers is a violation of the law.

In a document with the unwieldy title of; Use, Abuse, Misuses, and Disposal of Prescription Pain Medication Time Tool Clinical Referenceamerican college of preventive medicineThe American College of Preventive Medicine (ACPM) states its position on the patient’s right to pain relief very clearly but the issue gets clouded in the “Challenges” section.  It is easy to see why many physicians find it easier to “pass the buck” by saying, “See your primary care physician for narcotics,” or, “See a physician who specializes in pain for treatment with controlled substances (for the full transcript and more click on this link: http://www.acpm.org/?UseAbuseRxClinRef

 INTRODUCTION – THE RIGHT TO PAIN CONTROL

Adequate pain control is a fundamental right of every patient [1]. A consensus statement from 21 Health Organizations and the Drug Enforcement Agency (DEA) conclude that “Effective pain management is an integral and important aspect of quality medical care, and pain should be treated aggressively… Preventing drug abuse is an important societal goal, but it should not hinder patients’ ability to receive the care they need and deserve.” [2]

The consequences of not treating pain are significant [1] [3] and confer a tremendous economic impact [4]. Post-surgical pain increases heart rate, systemic vascular resistance, and circulating catecholamines, placing patients at risk of heart attack, stroke, bleeding, and other complications. Unrelieved acute pain often evolves into chronic pain syndromes, which are linked to a constellation of maladaptive physiological, psychological, family, and social consequences that result in:

  • ·        Reduced mobility; loss of strength
  • ·        Disturbed sleep
  • ·        Decreased healing due to immune system impairment
  • ·        Increased susceptibility to disease
  • ·        Dependence on medication
  • ·        Codependence with family members or care givers
  • ·        Psychological ramifications (depression, anxiety, social withdrawal)
  • ·        Slower return to function
  • ·        Decreased quality of life

. UNIVERSAL CHALLENGE

  • Physicians are currently challenged to deal with the “perfect storm”—a confluence of pain control versus risk of misuse and abuse of prescription medications [5].
  • This perfect storm is co-incident with the more general rise in unintended overdose deaths that may have resulted from aggressive efforts to have physicians treat pain without the education, skill and resources to manage the physiological and psychological complications that can arise when treating a patient for a chronic pain condition. Physicians must be able to safely and effectively prescribe scheduled drugs and, at the same time, must identify and manage misuse and abuse in their practices [6]. Ethics drive physicians to prescribe, but fear of sanctions may affect physician prescribing behaviors, which might compromise quality of care. The problem cannot be ignored because abusers often face complications, such as: [7]
    • ·        Overdoses
    • ·        Addiction and dependence
    • ·        Adverse effects
    • ·        Social and family dysfunction
    • ·        Criminal consequences

The universal challenge is to adequately control pain, having a variety of etiologies, in an environment where evidenced-based medicine is lacking or in conflict, while identifying and managing high risk situations, and possibly treating addictions resulting from initial pain control efforts. Physicians confront the dilemma of balancing pain relief against the reality that some patients may misuse and divert these medications. The scale weighs public health priorities against individual pain and suffering [8].

Some physicians are so nervous about prescribing painkillers that they just flat out refuse to do so. I had it happen to me at of all places a well-known pain clinic.  These physicians fail to recognize chronic pain for what it is and want to find the underlying condition that causes the pain but the fact is the pain is the underlying condition.

J. Donald Schumacher President and CEO of the National Hospice and Palliative Care Organization says, “According to a recent report from the Institute of Medicine, chronic pain itself can be the problem. Such pain can cause changes in the nervous system that worsen over time — even after the original source of the pain has gone away.

Because many doctors are not properly trained in the study of chronic pain, patients often suffer unnecessarily. One study of nursing home residents with chronic pain found that 44 percent were not getting any treatment at all.

In some cases, the need for pain treatment may not be obvious. Older patients, especially those with dementia, often struggle to communicate their needs.

Yet according to a report from the Hartford Institute of Geriatric Nursing at New York University, the burden to communicate with patients who may be in pain does not rest with the patients. Clinicians must take on that duty. They can do so by learning to identify non-verbal behaviors, such as “agitation, restlessness, aggression, and combativeness,” which “are often an expression of unmet needs.”

Old age must not become an excuse for the failure to pursue effective treatment for pain.

Of course, patients must assume some responsibility for treating their pain, too. Approximately 50 percent of patients do not take their medication as prescribed. Many mistakenly wait for pain to recur before administering another dose. Such on-again, off-again treatment just results in cycles of pain — rather than preventing it altogether by maintaining adequate levels of medication in the bloodstream.”

Schumacher also believes this, “Whatever the condition causing the pain, the person best equipped to take the lead in finding the proper treatment is the sufferer. People know their own bodies, and they can judge when medications are inducing unwanted side-effects.

No one deserves to be incapacitated by chronic pain. The means to alleviate it are available. All that’s required is the will to find the right treatment.”

So what else can patients do to get relief when the system seems obsessed with denying it?

In a Web MD Story, Rollin M. Gallagher, MD, MPH, director of pain management at the Philadelphia VA Medical Center said, “Today’s pain specialists understand how the sensation of pain occurs — how the nervous system, including the spinal cord, interacts with the brain to create that sensation.

Insights into the neurotransmitter system — the chemical messengers that pass nerve signals — have opened the door for important new modes of chronic pain relief, he explains. In recent years, scientists have learned how to manipulate those chemical messengers to change the way they interact with the brain’s signals.

That’s led to use of antidepressants and other drugs that work with specific brain chemicals that affect emotions, and help with perception of pain. We now have a whole new host of medications that are very effective for chronic pain relief,” Gallagher tells WebMD. http://www.webmd.com/pain-management/features/chronic-pain-relief-new-treatments 

medtronicIn November of 2011 Medtronic Corporation the manufacturer of a wide variety of medical devices announced a new treatment for chronic pain. In a news release the Minnesota corporation said, “The U.S. Food and Drug Administration (FDA) has approved AdaptiveStim™ with RestoreSensor™ neurostimulation system, the first and only chronic pain treatment that harnesses motion sensor technology found in smart phones and computer gaming systems to provide effective pain relief and convenience by automatically adapting stimulation levels to the needs of people with chronic back and/or leg pain.

The news release went on to say, “Data from the U.S. RestoreSensor clinical trial demonstrate that the AdaptiveStim with RestoreSensor neurostimulator provides effective pain relief and convenience. At the end of the study, 86.5 percent of study participants with chronic pain, who were included in an intent-to-treat analysis (n=74), experienced somewhat better or much better pain relief with no loss of convenience, or somewhat more or much more convenience with no loss of pain relief, when the device’s AdaptiveStim technology was turned on, compared to a control period when the participants manually adjusted neurostimulation settings using a patient programmer. With AdaptiveStim, study participants reported functional improvements, including improved comfort during position changes (80.3 percent).”

Not to be outdone, Boston Scientific is also in the chronic boston scientificpain management business On April 12 of this year they announced, Boston Scientific Corporation (NYSE: BSX) has received approval by the U.S. Food and Drug Administration and is beginning a limited launch of the Precision Spectra Spinal Cord Stimulator (SCS) System.  The Precision Spectra System is the world’s first and only SCS system with Illumina 3D™ software and 32 contacts, and is designed to provide improved pain relief to a wide range of patients who suffer from chronic pain.

The news release added, “The Precision Spectra System represents a paradigm shift in spinal cord stimulation,” said Giancarlo Barolat, M.D., medical director of Barolat Neuroscience in Denver.  “The Illumina 3D Software is the first SCS programming technology based on advanced anatomical and scientific principles.  When combined with 32 contacts and four lead ports—twice that of any other SCS system—the Precision Spectra technology gives physicians more flexibility to customize therapy for patients.”  

Medications for Treating Pain http://www.livestrong.org/we-can-help/preparing-yourself/finding-a-counselor/

Cancer pain is often treated with one or more medications. If you have concerns about taking certain medication, discuss this with your health care provider and pharmacist. Ask about long-term medication usage and side effects, such as allergies, constipation, sedation, memory impairment or other reactions.

  • For mild pain: Medications such as acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs) may provide relief. Some of these drugs, such as ibuprofen or naproxen, can be purchased without a prescription.
  • For moderate pain: Medications that combine an opioid (sometimes called a narcotic) such as hydrocodone or oxycodone with acetaminophen or aspirin may be needed. Vicodin and Percocet are examples.
  • For severe pain: Medications that contain an opioid only (sometimes called a narcotic) such as morphine, oxycodone, fentanyl or methadone are usually needed. These narcotic medications may be given orally or intravenously (or sometimes both).
  • For bone pain: When associated with metastatic cancer treatment for bone pain can include bone-strengthening steroid medication known as bisphosphonates. (Radiation therapy and surgery may also be very effective in relieving symptoms.)
  • Antidepressants medications: Amitriptyline and duloxetine, for example, can be very helpful in managing chronic pain.
  • Gabapentin and pregabalin: Originally developed to treat epilepsy, these can also be used for chronic pain, including neuropathic pain caused by nerve injury.
  • Topical anesthetics: Lidocaine pain patches, for example, may be helpful in some cases.

Complementary Pain Relief Options

Complementary (also called alternative or holistic medicine) treatments include massage, acupuncture, meditation, biofeedback or hypnosis. For some types of pain, heating pads, hot or cold packs and massage may be soothing and can help to reduce pain.

A health care provider may recommend counseling to help a patient cope with their pain or other distressing symptoms. Stress can make pain worse. It can also lessen the effect of pain management medications.

To learn more about these types of therapies, contact the National Cancer Institute. Talk with your health care team if you are interested in adding a complementary method of treatment. Let them know about supplements and herbs you want to try. Some types of complementary treatments can interfere with treatments prescribed by your provider.

Stem Cell Therapy

While there is a great deal of anecdotal evidence that stem cell therapy has beneficial applications there is little real medical evidence and many researchers, physicians and regulators still view much of stem cell therapy as modern day quackery.

I know you can find many people who have had stem cell therapy and swear by it but to the medical community that is still anecdotal evidence unsupported by clinical studies and therefore “iffy” or even dangerous.  It is important to note that even among physicians who are among the most trusted members of our society, there are those whose greed supersedes professional ethics.  These charlatans prey on a trusting public and can do more harm than good.  An example is the FDA and DEA crackdown on hundreds of physicians who indiscriminately prescribe controlled substances to anyone who wants them.  The best advice always is, “Buyer beware!”

In researching the subject for this blog I was struck again and again by conflicting opinions which convinced me that it is nearly impossible for a lay person like me to sort out the science from the pseudo-science and offer sound advice. I am simply not qualified to do so which means the burden falls back on the reader and depends on the illness in question, its severity and what has been done to treat it in the past.

I can only suggest this.  There are claims being made by clinics all over the world about successful stem cell therapies covering everything from bad knees to multiple sclerosis.  If you are seeking such therapy start out by talking to your primary care physician and getting his/her advice.  If still not satisfied look for a respected specialist in the field at a major medical center and finally if you still need more information, look up a highly respected medical school that also does research into stem cell therapy and inquire with them about your concerns.  I would avoid calling the stem cell clinics that sell the treatment because there is no way you will get an objective response from them.

In December of 2012 I published a blog on the issue of stem cell therapy titled Stem Cell Therapy – Some Truth, lots of Snake Oil. https://bobsnewheart.wordpress.com/2012/12/03/stem-cell-therapy-some-truth-lots-of-snake-oil/

I spent a considerable amount of time researching the issue before posting and little has changed since then.  If Stem Cell therapy is a consideration for you please read it and click on the many links I have provided.  They may not give you the answers you want but they will give you objective and accurate information.  Ultimately the decision is yours and yours alone. The U.S. Food and Drug Administration (FDA) is still struggling with the stem cell issue and until they can sort it all out I would proceed with great caution.

As you can gather, there’s a lot of confusion and misleading information about stem cell therapy because research is really in its infancy.  The International Society for Stem Cell Research (ISSCR) has a lot of information about stem cells and lists 10 things you should know about the subject on this link http://www.closerlookatstemcells.org/Top_10_Stem_Cell_Treatment_Facts.html

Here is just one of the ten.

4.  Just because people say stem cells helped them doesn’t mean they did.

There are three main reasons why a person might feel better that are unrelated to the actual stem cell treatment: the ‘placebo effect’, accompanying treatments, and natural fluctuations of the disease or condition.

The intense desire or belief that a treatment will work can cause a person to feel like it has and to even experience positive physical changes, such as improved movement or less pain. This phenomenon is called the placebo effect. Even having a positive conversation with a doctor can cause a person to feel improvement. Likewise, other techniques offered along with stem cell treatment—such as changes to diet, relaxation, physical therapy, medication, etc.—may make a person feel better in a way that is unrelated to the stem cells. Also, the severity of symptoms of many conditions can change over time, resulting in either temporary improvement or decline, which can complicate the interpretation of the effectiveness of treatments.

These factors are so widespread that without testing in a controlled clinical study, where a group that receives a treatment is carefully compared against a group that does not receive this treatment, it is very difficult to determine the real effect of any therapy. Be wary of clinics that measure or advertise their results primarily through patient testimonials.

ISSCR offers a great deal more information on stem cell research and therapy on their home site at http://www.closerlookatstemcells.org/

Finally, Forbes magazine, admittedly very conservative in its approach to almost anything, ran this story about stem cells here’s an excerpt and a link. http://www.forbes.com/sites/gerganakoleva/2012/02/19/stem-cells-fda-and-the-edge-of-science-three-expert-viewpoints/

Forbes excerpt

“The question for us as a society is when something done at the edge of clinical care becomes something we want to study,” Scott observed. “My feeling is that in many cases clinics are scrambling to get approval, but don’t have the gravitas that the clinical literature provides that would give comfort to a regulatory agency or even an advisory board to say ‘go ahead and do it.’ So until we have a better idea of what the adverse effects would be, these things are moving too quickly.”

Other Pain Treatment Options

Biofeedback is a method that uses the mind to help with pain. Breathing exercises, relaxation techniques, yoga, tai chi, qigong, visualization, meditation or guided imagery exercises may also be effective. Sometimes, talking with friends, laughing or listening to music can offer a helpful distraction from pain.

For severe pain, a technique called a nerve block is sometimes considered. This procedure may involve injecting a substance directly into or around a nerve or around the spinal cord. These procedures block damaged nerves from sending pain signals to the brain so that the pain will not be felt. Nerve blocks may work to control pain for people who have advanced cancer or very painful nerve conditions. However, there can be serious complications associated with these procedures.

Talk with your health care provider about the benefits and risks before any treatment to decide what is best for your situation. Every survivor responds differently to pain management strategies. Open communication with your health care team can help you decide together what will work best to manage your pain.

Conclusion

After considerable research Bob’s Newheart has come to the conclusion that while there are forces at play that would deny patients relief from chronic pain, there is also help available.  Unfortunately the medical profession is more a part of the problem than the solution despite its protestations to the contrary.  For any doctor to deny relief to a patient with legitimate pain is to us a violation of their oath. 

Chronic pain is a medical reality that affects not only the body but the emotional stability of the patient as well.  Any patient who says, “I cannot go on living like this,” and is denied relief for fear of being investigated is in desperate straits.  When my pain specialist said to me, “I can’t give you narcotics, see your primary,” he was not only lying he was telling me he didn’t’ care about my pain.

Narcotics or controlled substances aren’t always the proper treatment but neither is denying these drugs to people who are in legitimate pain. 

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bob minus Jay full shotBob Aronson is a 2007 heart transplant recipient.  He is the founder of Facebook’s 3000 plus member Organ Transplant Initiative (OTI) and the author of most of these Bob’s Newheart Blogs. 

All that’s required to join OTI is that you support our mission and follow the rules for the group.  You can read about both in the “About” section on the right side of the OTI group page.

 

 

 

What’s In That Prescription Bottle and What Does It Do? Generic V. Brand


pay more get weel quicker By Bob Aronson

What’s In That Prescription Bottle and What Does It Do?

The question asked by our headline would seem to have an obvious answer but it doesn’t because there isn’t one.  We may know the medication that’s in the bottle but what It does is another story. Each drug has a primary effect and many side effects.  Side effects can be minimal or dangerous and we are left to trusting our physicians.  But, do they really know what they are prescribing?

According to Dr. Ben GoldacreDr. Ben Goldacre they don’t because they don’t have all the information they need.   Goldacre is a best-selling author, broadcaster, campaigner, medical doctor and academic who specialises in unpicking the misuse of science and statistics by journalists, politicians, quacks, drug companies, and more.

bad scienceHis first book “Bad Science” (4th Estate) has sold over 500,000 copies to date, is published in 18 countries, and reached #1 in the UK paperback non-fiction charts. bad pharmaBad Pharm, just out, is on bad behaviour in the pharmaceutical industry and medicine more broadly: it is now a top ten UK best seller.

Here’s what Goldacre says about, “What’s in that Bottle?”

“Doctors need the results of clinical trials to make informed choices, with their patients, about which treatment to use. But the best currently available evidence estimates that half of all clinical trials, for the treatments we use today, have never been published. This problem is the same for industry-sponsored trials and independent academic studies, across all fields of medicine from surgery to oncology, and it represents an enormous hidden hole for everything we do. Doctors can’t make informed decisions, when half the evidence is missing.

Most people react to this situation with incredulity, because it’s so obviously absurd. How can medics, academics, and legislators have permitted such a huge problem to persist? The answer is simple. This territory has been policed — and aggressively — by the pharmaceutical industry. They have worked hard to shut down public discussion on the topic, for several decades, with great success.

They say, for example, that the problem is modest, and that critics have cherry picked the evidence: but this is a lie. The best evidence comes from the most current review of all the literature, published in 2010. It estimates that half of all completed trials are left unpublished, and that trials with negative results are about twice as likely to be buried.

Then they pretend that the problem is in the past, and that everything has been fixed. But in reality, none of these supposed fixes were subjected to any kind of routine public audit, and all have now been well-documented as failures. What’s more, they all shared one simple loophole: they only demanded information about new trials, and this is hopeless. Anything that only gets us the results of studies completing after 2008 does nothing to fix medicine today, because more than 80% of all treatments prescribed this year came to the market more than ten years ago. We need the results of clinical trials from 2007, 2003, 1999, and 1993, to make informed decisions about the medicines we use today. This isn’t about catching companies out for past misdemeanors, it’s a simple practical matter of making medicine optimally safe and effective.” (You can watch Dr. Ben in action here  http://tinyurl.com/opvzsjn )

OK…having established that we need to force the FDA and big Pharma to release more information let’s turn to the subject of Generic drugs.  Are they really the same as he band name?  The answer is, “No, not entirely!”  Did you know they aren’t even tested?

busting the myths

For more on the generic story let’s turn to Dr. Tod Cooperman.  He is not only an MD but also the President of Consumerlab.com.  Here’s what he says,

“More than 80Dr. Todd Cooperman% of the drugs we take in the US are now generic versions of brand name medications. You may think that these drugs are equivalent to their branded counterparts, but that’s not always the case. Here are some important facts and tips to stay safe with generic drugs.”

Fact: You may get more or less active drug from a generic.

The FDA only requires that you get 80% to 125% of the drug into your bloodstream from a generic medication compared to the original drug. What’s even more concerning is that there are often many different generic versions of the same drug, and each of these may be different as well.  rx logoConsider this: If you take a generic which only meets the minimum requirement and refill that prescription with one that’s at the maximum limit, you’ve potentially increased the amount you get into your body by as much as 45% percentage points – and you would have no way of knowing this from the labels, but it could certainly affect you. The opposite could also happen, and you would be getting a lot less drug than you were previously – which could also affect you.

This is particularly troubling for medications for which blood levels must be kept in a narrow range in order to be effective and/or to avoid toxicity. These can include:

Thyroid medication

Anti-seizure medication

Blood thinners

Antidepressants

Antipsychotics

Asthma medications

Immunosuppressants

Fact: Other than the active ingredient, a generic may contain very different other binders and fillers.molecules

Most of the ingredients in a pill are not the active ingredient but other ingredients needed to hold the pill together, coat it, and control the way the pill delivers its drug in your body. These other ingredients can be different in a generic version of a drug. It is possible to have an allergic reaction or sensitivity to one of these ingredients. With some extended-release products, the brand name formula is still patented, so the generics may be completely different in their formulation. This can affect how fast or slow they release their drug and how this is affected by things like whether you take the pills with food or not. http://www.doctoroz.com/videos/what-you-need-know-about-generic-drugs

Fact: Generics are not tested like brand name medication.

While brand name medication is tested for safety and efficacy before being approved, generics are not. The only human test in people that is required is a bioequivalence test, conducted by the manufacturer in a small number of healthy individuals. This test must show that the product delivers approximately the same amount of drug into your blood stream and approximately the same rate.

Fact: Labels on most generic drugs are incorrect.FDALOGO

The FDA requires that the package inserts for generic drugs show the data (the “pharmacokinetic” data) from the brand name medication as if it is were based on the performance of the generic drug. In actuality, the data for the generic is typically different, but the FDA does not release this information.

Fact: In 2012, the FDA conceded that several generic antidepressant medications had never been tested and one was pulled from the market.

These were generic versions of Wellbutrin XL 300. One of them, called Budeprion XL 300 (Teva), had been on the market since 2006. Four others remain on the market. ConsumerLab.com drew attention to problems with this group of drugs in 2007 when it showed the Teva product did not dissolve like the original drug and many people switched to the drug reported that it was not working and some reported becoming suicidal. (Access to ConsumerLab.com’s report is available through a 24-hour free pass to Dr. Oz viewers. Visit ConsumerLab.com/DoctorOz now and get immediate access.)

So, given all that information, what do you do with it. Here’s what Dr. Cooperman suggests.

Guidelines if you are going to take Generic drugs

Guideline 1: Consider brand names for extended-release generic drugs.

While the active ingredients may be identical, the pills and their other ingredients in extended-release medications may not be. This makes extended-release generics, which typically have XL, ER, or SR in their names, more susceptible to delivering lower or higher amounts of the drug into your blood stream and at faster or slower rates than the brand name medication. As noted, this has been an issue with generic Wellbutrin XL 300. Concerns have also been reported with generic versions of Toprol XL. ConsumerLab.com has published reports on these products.

Guideline 2: Identify the manufacturer for generic drugs.

Not all generics behave the same way. If your generic is working, you should request the same manufacturer each time you refill that prescription. You can find the name (sometimes an abbreviation) on the bottle. Don’t be shy. You can call around to try to find the same product. Pharmacists will tell you which version they are currently selling and may be able to get the version you want.

Guideline 3: Find out if an “authorized” generic exists for your drug.

These are generics typically made by the same manufacturer of the brand name medication but sold under a generic brand name. They are not “similar” to the brand name drug – they are identical to it. They just have a different imprint on them. Ask your pharmacist if one exists for your medication.

Guideline 4: When switching to a generic, monitor your condition carefully.

When switching from a brand name to a generic drug, or from one generic to another, note any changes you feel and tell your doctor immediately. It could be a difference in the medication causing the changes in you.

If you have experienced an unexpected and adverse change in your condition after being switched to a generic medication, you or your doctor may also want to report this to the FDA though its MedWatch program. You can also report this to ConsumerLab.com, which may choose to investigate the issue.

Bob’s Newheart will be watching closely as more brand names become generic and we’ll report significant developments to you as we discover them.

Bob informal 3Bob Aronson of Bob’s Newheart is a 2007 heart transplant recipient, the founder of Facebook’s nearly 3,000 member Organ Transplant Initiative and the author of most of these donation/transplantation blogs.

You may comment in the space provided or email your thoughts to me at bob@baronson.org. And – please spread the word about the immediate need for more organ donors. There is nothing you can do that is of greater importance. If you convince one person to be an organ and tissue donor you may save or positively affect over 60 lives. Some of those lives may be people you know and love.

Please view our music video “Dawn Anita The Gift of Life” on YouTube https://www.youtube.com/watch?v=eYFFJoHJwHs.  This video is free to anyone who wants to use it and no permission is needed.

If you want to spread the word personally about organ donation, we have another PowerPoint slide show for your use free and without permission. JAgain, write to me and ask for “Life Pass It On.”  I will email it to you immediately.  This is NOT a stand-alone show; it needs a presenter but is professionally produced and factually sound.  If you decide to use the show I will  also send you a free copy of my e-book, “How to Get a Standing “O” that will help you with presentation skills. Just write to bob@baronson.org and I will send the show and book ASAP.

Also…there is more information on this blog site about other donation/transplantation issues. Additionally we would love to have you join our Facebook group, Organ Transplant Initiative  (OTI).  The more members we get the greater our clout with decision makers.

En Espanol

Bob Aronson de Newheart de Bob es un centro receptor de trasplante 2007, el fundador de la Iniciativa de Facebook cerca de 3.000 miembros de trasplantes de órganos y el autor de la mayoría de estos blogs de donación / trasplante.

Usted puede dejar un comentario en el espacio proporcionado o por correo electrónico a sus pensamientos a mí en bob@baronson.org. Y – por favor difundir la palabra acerca de la necesidad inmediata de más donantes de órganos. No hay nada que puedas hacer lo que es de mayor importancia. Si se convence a una persona para ser un donante de órganos y tejidos puede salvar o positivamente afectará a más de 60 vidas. Algunas de esas vidas puede haber gente que conoces y amas.

Por favor, vea nuestro video musical “Dawn Anita The Gift of Life” en YouTube https://www.youtube.com/watch?v=eYFFJoHJwHs. Este video es libre para cualquier persona que quiera usarlo y no se necesita permiso.

Si quieres correr la voz personal sobre la donación de órganos, tenemos otra presentación de PowerPoint para su uso gratuito y sin permiso. JAgain, escribir a mí y pedir “Life Pass It On.” Voy a enviar por correo electrónico a usted inmediatamente Esto no es un espectáculo independiente,. Necesita un presentador, pero es producido profesionalmente y objetivamente sonido Si usted decide utilizar el archivo. demuestro que también le enviará una copia gratuita de mi libro electrónico, “Cómo obtener un Standing” O “que le ayudará con habilidades de presentación. Sólo escribo bob@baronson.org y enviaré el programa y el libro lo antes posible.

Además … hay más información sobre este sitio de blogs de otros temas de donación / trasplante. Además, nos encantaría que te unas a nuestro grupo de Facebook, la Iniciativa de Trasplante de Órganos (OTI). Cuantos más miembros que tienen la mayor influencia en nuestra toma de decisiones.

Supremes Say You Can’t Sue Generic Drug Makers But FDA May Change That


On June 24, 2-13 the U.S. Supreme Court, in a 5-4 decision ruled that generic drug manufacturers are not liable for the design of the drugs. supreme court That means if their drugs make you sick you can’t sue them. gavel on money One could easily believe that’s like saying that a Jet passenger airliner that was approved as safe by the FAA in the 1960’s is immune from all law suits even if in ensuing years it was proven that stress fractures caused engines to fall off and planes to crash killing hundreds— but I am getting ahead of myself and besides a ruling by the Food and Drug Administration (FDA) could change all that.  Confused?  Read on.

Before we get to the decision it is important to understand just what a generic drug is and how it becomes one.  When a new, FDA-approved drug goes on the market, it may have patent or other protection that enables the manufacturer to sell the drug exclusively for a period of time. When those protections expire other companies can make it in generic form but the FDA must approve the generic drug before it can be marketed.FDA approved drug

For a generic drug to be approved by FDA, its manufacturer must show that it is “equivalent” to the innovator drug (brand name). This means that to gain FDA approval, a generic drug must:

  • Contain the same active ingredients as the innovator drug. Active ingredients make the drug effective against the disease or condition it is treating.
  • Come in the same dosage form. If the brand name is a capsule, the generic should be a capsule, too.
  • Be administered the same way. If the brand name is taken orally, the generic should be taken orally, too.
  • Be identical in strength
  • Have the same conditions of use
  • Be bioequivalent (an equal rate and extent of drug absorbed in the bloodstream)
  • Meet the same standards for identity, strength, purity and quality
  • Be manufactured under the same standards that FDA requires for the manufacture of innovator products

As I researched this story I found that the FDA encourages people to notify them of side effects or reactions to these generic drugs.  I found little or no information that suggested how or even if the FDA acted upon public complaints so conceivably there could be a great number of complaints about an adverse effect  but if the FDA takes no formal action the Generic manufacturer has no obligation to issue any warnings or reformulate the drug…which leads us to today’s supreme court ruling.

In a dissenting opinion, Justice Sonia Sotomayor said a decision by the F.D.A. to approve a drug should not absolve a company of its responsibility to sell a safe product.

“Manufacturers regularly take drugs off the market when evidence emerges about a drug’s risks, particularly when safer drugs that provide the same therapeutic benefits are available,” she wrote in her dissent, which was joined by Justice Ruth Bader Ginsburg. Justice Stephen G. Breyer wrote a separate dissent, which was joined by Justice Elena Kagan.

Some have called on Congress and the F.D.A. to make generic drug companies more accountable by permitting them to change their warning labels when they become aware of a safety risk. Brand-name companies can already do so. Such a change would, presumably, allow the generic manufacturers to be sued again. FDA sign

Generic drug makers now have a responsibility to mirror the safety label of the brand-name company and to alert the F.D.A. whenever they learn of an adverse event related to their products. It is then up to the agency to decide whether to change the label.

Critics have said the current system works too slowly, and does not account for situations when problems arise with a drug after the brand-name manufacturer has left the market.

The consumer advocacy group Public Citizen released a report Monday that found 11 instances over the last five years in which serious safety warnings were added to the labels of drugs for which there were no longer any brand-name versions on the market.

This situation “poses a threat to the safety of prescription drugs, creating unnecessary risks to patients,” Dr. Michael Carome, director of the Health Research Group at Public Citizen, said in a statement Monday.

But now a new twist.

The June action by the supreme  court slashed the right of individuals to sue for damages when injured by generic drug makers…..but an action by the Food and Drug Administration might change that.   The Times Katie Thomas reported this good news yesterday:

Consumer advocates applauded the development, calling it a necessary fix for a system that they say is unfair to patients who take generic medicines. FDA logo

“It’s common sense,” said Dr. Sidney M. Wolfe, a senior adviser to the Health Research Group at Public Citizen, which in 2011 petitioned the F.D.A. to pass just such a rule. “It will obviously end this situation where people are being harmed physically and yet, although they are harmed, they have no right to go into court and get redress for serious damages.”

Dozens of lawsuits against generic drug manufacturers have been dismissed since 2011, when the Supreme Court ruled that because the generic companies must, by law, use the same label warnings as their brand name counterparts they cannot be sued for failing to alert patients about the risks of taking their drugs. Last month, the Supreme Court ruled — on similar grounds — that patients also may not sue generic drug makers by claiming that the drug was defectively designed.

Have we heard the last of this issue? No way.  The pharmaceutical industry has billions to spend to defend itself and to launch massive PR campaigns.  They’ve done it in the past and you can bet the will do it again.  Stay tuned. 

Bob Aronson of Bob’s Newheart is a 2007 heart transplant recipient, the founder of Facebook’s nearly 3,000 member Organ Transplant Initiative and the author of most of these donation/transplantation blogs.

You may comment in the space provided or email your thoughts to me at bob@baronson.org. And – please spread the word about the immediate need for more organ donors. There is nothing you can do that is of greater importance. If you convince one person to be an organ and tissue donor you may save or positively affect over 60 lives. Some of those lives may be people you know and love.

Please view our new music video “Dawn Anita The Gift of Life” on YouTube https://www.youtube.com/watch?v=eYFFJoHJwHs.  This video is free to anyone who wants to use it and no permission is needed. 

If you want to spread the word personally about organ donation, we have another PowerPoint slide show for your use free and without permission. Just go to http://www.organti.org and click on “Life Pass It On” on the left side of the screen and then just follow the directions. This is NOT a stand-alone show; it needs a presenter but is professionally produced and factually sound. If you decide to use the show I will send you a free copy of my e-book, “How to Get a Standing “O” that will help you with presentation skills. Just write to bob@baronson.org and usually you will get a copy the same day.

Also…there is more information on this blog site about other donation/transplantation issues. Additionally we would love to have you join our Facebook group, Organ Transplant Initiative The more members we get the greater our clout with decision makers.

En Espanol

Puede comentar en el espacio proporcionado o por correo electrónico sus pensamientos a mí en bob@baronson.org. Y – por favor, difundir la palabra acerca de la necesidad inmediata de más donantes de órganos. No hay nada que puedas hacer lo que es de mayor importancia. Si usted convence a una persona de ser donante de órganos y tejidos puede salvar o afectar positivamente a más de 60 vidas. Algunas de esas vidas pueden ser personas que conoces y amas.

Por favor, consulte nuestro nuevo video musical “Dawn Anita The Gift of Life” en https://www.youtube.com/watch?v=eYFFJoHJwHs YouTube. Este video es libre para cualquier persona que quiera usarlo y no se necesita permiso.

Si quieres correr la voz acerca de la donación de órganos personalmente, tenemos otra presentación de PowerPoint para su uso libre y sin permiso. Sólo tienes que ir a http://www.organti.org y haga clic en “Life Pass It On” en el lado izquierdo de la pantalla y luego sólo tienes que seguir las instrucciones. Esto no es un espectáculo independiente, sino que necesita un presentador pero es profesionalmente producida y sonido hechos. Si usted decide usar el programa le enviaré una copia gratuita de mi libro electrónico, “Cómo obtener un pie” O “que le ayudará con habilidades de presentación. Sólo tiene que escribir a bob@baronson.org y por lo general usted recibirá una copia del mismo día.

Además … hay más información sobre este sitio de blogs sobre otros donación / trasplante temas. Además nos encantaría que te unas a nuestro grupo de Facebook, la Iniciativa de Trasplante de Órganos Cuantos más miembros que obtenemos mayor será nuestra influencia con los tomadores de decisiones.

 

 

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