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Why Prescriptions Cost So Much and What You Can Do About It


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A couple of weeks ago the news was filled with stories about Martin Shkreli the CEO of Turing Pharmaceuticals, a relatively small drug manufacturer. Some media branded him with this headline world's biggest a holebecause he raised the price for one pill of Daraprim, a 62 year old drug,
from $13.50 to $750. That’s about 5,000 percent. Now, he says he will lower the price, but there’s no indication of how much or, as of this writing, when (According to Web MD Daraprim is used with other medication (such as a sulfonamide) to treat a serious parasite infection (toxoplasmosis) of the body, brain, or eye or to prevent toxoplasmosis infection in people with HIV infection).

As it turns out, though, the “World’s Biggest A–Hole case is not in the least bit unusual, it happens with pharmaceutical companies with great regularity as a tactic to increase profits on older drugs, drugs that have long since paid for themselves.

The global market for pharmaceuticals topped $1 trillion in sales in 2014. The world’s 10 largest drug companies generated $429.4 billion of that revenue. Five of these companies are headquartered in the U.S. They are: Johnson & Johnson, Pfizer, Abbot Laboratories, Merck and Eli Lilly.

Johnson and Johnson, America’s biggest pharmaceutical manufacturer raised prices on over 130 brand name products this year alone. Merck & Co. raised the price of 38 drugs. The increases in the U.S. have added over a billion dollars of revenue in the last three years. So, while Mr. Shkreli may get the award for being the biggest you know what, he is in good company — only the others were smart enough not to brag about it.

Before I go on it is important to point out that my interest in the topic is both personal and professional. I am a senior citizen, who has had a heart transplant and who also has Chronic Obstructive Pulmonary Disease (COPD). I take a good number of prescription drugs and despite having Medicare Part D insurance I still pay thousands of dollars a year for my prescriptions. Most of the drugs I take have been around for quite a while, but not long enough to allow the sale of generics and because there are few if any pricing restrictions, most of my meds are outrageously high priced.

One of the drugs I take is called Foradil. It was approved by the FDA in February 2001 for the maintenance treatment of asthma and the prevention of bronchospasm in reversible obstructive airways disease. Despite being on the market that long, it still retails for about $250.00 for a 30 day supply. Spiriva is another COPD drug and is often taken with Foradil. It retails for about $350.00. I take about a dozen drugs and these two alone total over $600.00 a month. Insurance cuts that cost in half, but they are still expensive. Because of these prices I know of many seniors and others who have to choose between eating and paying for their prescription meds.

In Europe, Asia, Australia and anywhere else with some form of socialized medicine strict government regulation helps prevent those kinds of actions and subsequently keeps prices down. Things are a whole lot looser in the U.S.

In 2013 each of us spent over $1,000 on prescription drugs. That works out to $429 billion. In case that figure boggles your mind, let me boggle it more by showing you what it looks like in black and white — $429,000,000,000. By anyone’s measure that’s a lot of money. To put it all in perspective Prescription medications make up close to 10 percent of the $2.9 trillion annual total spent on healthcare in the U.S.

Americans spend more on drugs than any other country in the world and – we also pay more for them than any other country.

big pharmaBefore we go into detail on why prescription drugs cost more here than anywhere else, let’s look at the biggest drug and biotech companies in the world. They account for more than a third of the industry’s total market share according to the World Health Organization. We won’t go into detail but here’s the top ten and their 2014 revenue.

  • Gilead Sciences $24.474 billion.
  • Bayer $25.47 billion.
  • AstraZeneca $26.095 billion.
  • GlaxoSmithKline $37.96 billion.
  • Merck’$42.237 billion.
  • Sanofi $43.07 billion.
  • Pfizer 49.605 billion.
  • Roche $49.86 billion.
  • Johnson & Johnson $74.331 billion.

If you were to ask any of those companies why prescription drugs cost so much they would likely tell you that the price reflects the immense costs of research and development. They would explain that it costs millions andcosts millions of dollars to develop a new drug and then millions more to get through animal and human studies and FDA approval, and that’s partially true. Partially. Those costs are very high, but what big pharma won’t tell you is that you are also paying for the costs of marketing the drug to physicians and patients and those costs dwarf the research and development expense. http://tinyurl.com/pr23j3q

The world’s largest pharma company, Johnson & Johnson, spent $17.5 billion on sales and marketing in 2013, compared with $8.2 billion for R&D. Most of that marketing effort is aimed directly at physicians, the people who write the prescriptions, rather than customers like you and me. It should be noted that the U.S. and New Zealand are the only two countries that allow any form of advertising for prescription drugs.

No sane person can object to a company making a profit, it’s part of the American way, but the drug industry’s profits are excessive. At the risk of being accused of repetitiveness I must say again. We pay significantly more than any other country for the exact same drugs. United States spends more than $1,000 per person per year on pharmaceuticals. Per capita drug spending in the U.S. is about 40 percent higher than Canada, 75 percent greater than in Japan and nearly triple the amount spent in Denmark. So why is that?

Well, first the U.S. is a very rich and therefore lucrative market because we use more medicine than any other developed country. We account for 35 percent of the world market for pharmaceuticals. Americans have become quite accustomed to leaving their doctor’s office with a handful of prescriptions.

Due to our ill health and our wealth, companies often choose the U.S. in which to launch new products. And, because the US market is so big and profitable, investments in research and development have long been steered towards meeting clinical needs.

But if we Americans take more prescription drugs, we also pay an arm and a leg more for them. Why? Because other countries have tough regulations about pharmaceutical prices and they set reimbursement limits. MedicareAnother smart thing they do is to agree to pay for a drug only if the price is justified by the medical benefits. In the U.S., Medicare which is the world’s largest buyer of prescription drugs is prohibited from negotiating prices with drug companies. If the company says that a pill is $100, Medicare has no choice, but to pay it if the patient needs it. They have no wiggle room and that costs taxpayers billions of dollars a year in a direct giveaway to the pharmaceutical behemoths and speaks to the power of their lobbyists.

Speaking of lobbyists, here’s the real rub. The pharmacy industry views congress as a place to invest against future price controls and this is what really adds to the price of your prescriptions.

Big Pharma Spends More on Lobbying Than Anyone
lobbyistsSince 1998, the industry spent more than $5 billion on lobbying in Washington, according to the Center for Responsive Politics. To put that in context, that’s more than the $1.53 billion spent by the defense industry and more than the $1.3 billion forked out by Big Oil.

From 1998 to 2013, Big Pharma spent nearly $2.7 billion on lobbying expenses — more than any other industry and 42 percent more than the second highest paying industry: insurance. And since 1990, individuals, lobbyists and political action committees affiliated with the industry have doled out $150 million in campaign contributions.

Now here’s how it works for you and me. In the U.S. insurers only accept the price set by the drug makers. If the drug is exclusive, meaning there is no competing medication from other companies. Insurers then cover the total cost by forcing a higher co-pay on patients. Unlike Medicare, insurers have bargaining power when there are competing drugs and therefore can reduce the co-pays.

generic drugs1Then, there is the Generic drug market, those are drugs in which the patent has run out and other manufacturers are allowed to produce the product. As an example the antidepressant Remeron is also known by its generic name Mirtazapine. Remeron is the brand name given it by the original manufacturer, but Mirtazapine can be made and distributed by any pharma company and sold for a much lower price.

Competition in that area is fierce and generic drug prices are usually low. Today generics account for about 85 percent of drugs dispensed in the U.S.

Despite generics and their low prices, there are still many Americans who daily make the choice between food or drugs, between paying the rent and drugs or giving up some other type of health care in order to afford the drugs that keep them going. Many Americans don’t take their recommended prescriptions because they can’t afford them. One recent survey showed that about one in five U.S. adults did not fill their prescription or skipped doses due to cost as opposed to Australia and some other countries where the ratio is one in ten. http://tinyurl.com/pejvoyn

Some people have turned to foreign sources for their prescriptions and advairthere are many with some of the more popular ones thriving in Canada. Here’s an example of the savings that can be had. If you want a three month supply of the popular asthma inhaler Advair it will likely cost you somewhere in the neighborhood of $600 to purchase it from one of your local pharmacies. If you select one of the Canadian pharmacies you can import the same three month supply of the same medication, Advair, for about $150, with shipping included. That amount may not mean much to the Donald Trump tax bracket, but to average Americans it’s a whole lot of money. Advair is just the tip of the iceberg. ABC news reports the following price comparisons:

  • Mirapex, for Parkinson’s disease: $157 in Canada vs. $263 in the United States.
  • Celexa, for depression: $149 in Canada vs. $253 in the United States.
  • Diovan, for high blood pressure: $149 in Canada vs. $253 in the United States.
  • Oxazepam, for insomnia: $13 in Canada vs. $70 in the United States.
  • Seroquel, for insomnia: $33 in Canada vs. $124 in the United States.

Tufts University in Boston released a study in the year 2000 that placed the cost of approval for a single drug at $802 million, and that was fifteen years ago. To be fair it must be revealed that the dollar amount adds in each successful drug’s prorated share of failures (only one out of fifty drugs eventually reaches the market), but that still does not explain why the retail price is higher here than anywhere else.

The only logical explanation I can come up after some a fair amount of research is that pharmaceutical companies can get away with much higher prices in the U.S. and they can’t elsewhere. Period!

So what are your options, what can average patients who have difficulty Optionaffording some drugs do to stay healthy and be able to eat and pay their rent and other bills at the same time?

Well, there are several steps you can take. Among them are:

  • Contact state and federal legislators and ask them to allow Medicare to negotiate the price of prescription drugs
  • Also ask them to allow importing of essential drugs from foreign companies through approved pharmacies.
  • Ask big pharma companies to see if you qualify for their reduced prices for people who have trouble affording them.
  • Read the Consumers Report story on the issue. It will give you the information you need to identify trustworthy pharmacies. http://tinyurl.com/qbflucm

But, if you are like me you want even more detail. Ok. Here’s the best I can do.

You can shop for the best price and because of the internet that’s become a whole lot easier. You can look up a specific drug and find the best price at a pharmacy near you. Here are two resources. I’m sure you can find a lot more https://www.lowestmed.com/Search#/  orhttp://www.goodrx.com/ All you have to do is type in the drug you need and your zip code and it will find the price of that drug in pharmacies near you.

Transplant recipients might be interested in the cost of anti-rejection drugs. The price is hard to stomach but easy to find. In my zip code 32244 100 Mg Cyclosporine capsules range in price from $526.00 at Wall Mart to $584 at Target. If you are a heart patient and take Carvedilol in my neighborhood it ranges from $4.00 at Wal Mart to $9.54 at Kmart. Lisinopril also has a wide range. At the Publix Supermarket pharmacy near me it is FREE…that’s right FREE.  But at CVS it is $12.00.  Those price variations might make it worth a little longer drive to get a better bargain.

You can also get help with coupons which are an obvious choice to savecouponmoney when grocery or clothes shopping, but they’re often overlooked as a way to cut costs of over-the-counter and prescription drugs. Manufactures frequently offer one time and repeat coupons that can save consumers hundreds of dollars on their medicines. “For our family it has been incredibly effective [in saving money] for a number of regular prescriptions,” says Stephanie Nelson, founder of the coupon website CouponMom.com.

The costs of prescription drugs and over-the-counter medications have been steadily rising and patients facing tight budgets are often forced to make hard decisions when it comes to what they can afford.

The savings vary by manufacturer, but many companies offer discounts at each prescription refill while others offer discount cards that take $20 off co-pays. Others offer one-time coupons to cover the first use of a drug.

  • Consumer Reports Magazine says that there are other ways to save money, too. Whichever drugstore or pharmacy you use, choosing generics over brand-name drugs will save you money. Talk to your doctor, who may be able to prescribe lower-cost alternatives in the same class of drug. In addition, follow these CR tips.
  • Request the lowest price. Our analysis showed that shoppers didn’t always receive the lowest
    available price when they called the pharmacy. Sometimes they were given a discounted price, and other times they were quoted the list price. Be sure to explain—whether you have insurance or not—that you want the lowest possible price. Our shoppers found that student and senior discounts may also apply, but again, you have to ask.
  • Leave the city. Grocery-store pharmacies and independent drugstores sometimes charge higher prices in urban areas than in rural areas. For example, our shoppers found that for a 30-day supply of generic Actos, an independent pharmacy in the city of Raleigh, N.C., charged $203. A store in a rural area of the state sold it for $37.
  • Get a refill for 90 days, not 30 days. Most pharmacies offer discounts on a three-month supply.
  • Consider paying retail. At Costco, the drugstore websites, and a few independents, the retail prices were lower for certain drugs than many insurance copays.
  • Look for additional discounts. All chain and big-box drugstores offer discount generic-drug programs, with some selling hundreds of generic drugs for $4 a month or $10 for a three-month supply. Other programs require you to join to get the discount. (Restrictions apply and certain programs charge annual fees.)
  • Experts say that although the low costs could entice you to get your prescriptions filled at multiple pharmacies, research indicates that it’s best to use a single pharmacy. That keeps all of the drugs you take in one system, which can help you avoid dangerous drug interactions.”

Finally, what do you do if you’ve done the shopping, used coupons, followed all of the Consumer Report Tips and are still unable to pay for your prescriptions? Well, there is some limited assistance. Here are some resources.

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bob half of bob and jay photoBob Aronson of Bob’s Newheart is a 2007 heart transplant recipient, the founder of Facebook’s over 4,200 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. Then, when registered, tell your family about your decision so there is no confusion when the time comes.

 

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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