AstraZeneca has agreed to pay fines totaling $520 million in settlement of charges made by the Food & Drug Administration (FDA) that AstraZeneca illegally marketed Seroquel; a prescription drug used for the treatment of schizophrenia.

Although Seroquel had not been approved by the FDA, AstraZeneca marketed and continued to market the drug for sometime after it was warned. The FDA says AstraZeneca wrongly made claims that Seroquel was appropriate for the treatment of:

• Alzheimer’s diseases
• Anxiety
• Dementia
• Depression
• Post-Traumatic Stress Disorder

To read some of the news surrounding the marketing of this drug, drug companies must use the same “play book” that Big Tobacco has used all these years.

The FDA says that not only did AstraZeneca violate promotional regulations of the drug; they also apparently are guilty of paying doctors to sign articles promoting the drug. The articles were actually written by employees or agents of AstraZeneca and the fees paid to physicians were largely to put their name on the article. That practice is called ghost writing and it is a practice that has been engaged in by pharmaceutical companies in the past as a way of artificially validating their drugs. In the world of “Joe Citizen” the practice of ghostwriting is also referred to as lying, cheating, an, well let’s just say it, fraud.

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Suppose that when a product malfunctions it was acceptable for the manufacturer to pay “experts”, recognized and notable professionals; to write articles, opinion letters, and studies, that spoke of the product’s safety. Articles that dispelled any notion that the product was really what was causing the problem.

Suppose that each of these “experts” was paid for their literary contributions, but did not disclose the payment.

Does not happen? Experienced, reputable “experts” would never agree to such a charade?

Unfortunately, it happens all the time.

I have been dealing with experts for many years and have often heard the trap of, “well, she teaches at ___________ School, she must know what she is talking about” or “he did clinical research at _______________ institution, he is certainly an expert”. These are constant traps people fall into. Where an expert teaches or was educated is a very small part of what does or does not make them an expert.

Experts are human. Experts can be influenced by money; by self interest, and by a really good “snow job” from a manufacturer.

This topic has once again raised its ugly head through discoveries made about the drug, Avandia. The Mayo Clinic did a retrospective study, in which they determined that many “experts” forgot to disclose financial ties they had with the manufacturer, GlaxoSmithKline.

Avandia is suspected of causing fluid retention, congestive heart failure, and heart attacks in diabetic patients.

It seems a good time for the pharmaceutical and medical device industry to adopt strict guidelines relating to disclosures of possibly prejudicing financial or other interests, which “experts” may have in connection with products or drugs.

If the industry will not do it voluntarily, perhaps it is overdue for the Food & Drug Administration to compel them.

Nearly 51% of all FDA approved drugs have serious adverse effects not discovered by the FDA until after the drug is approved and on the market.

How does this happen?

The FDA is not meant to be a true filter for the efficacy of drugs. They have neither the staff nor the funding to be able to verify the research and data submitted by drug manufacturers. Like it or not, the FDA, in large measure, must rely on the honesty and competence of the evaluations carried out by the very companies who seek to make profits on ultimately marketing a prospective drug.

Direct to consumer advertising is a problem. Prescription drugs are one of the few products in which manufacturers spend billions of dollars to sell you something you can not buy. Well, you can not buy the product unless a physician agrees. Drug manufacturers, though, continue to create elaborate TV ads to lure Americans to this drug or that drug. When yo are finished watching some of these ads, you are convinced you have a disease you never imagined you had before; due to the power of suggestion.  A drug for everything and a disease for every drug.

Why eat healthy if you can take a pill that helps you lose weight or take a pill that lowers your cholesterol?

The over prescribing of antibiotics, for example, is causing antibiotic resistant strains of viruses, flus, and “bugs” that are becoming increasingly dangerous to the public.  Almost every medication on the market can cause life-threatening side-effects leaving us to ask “is the cure worse than the illness?”

What can the consumer do?

Ask questions.
Demand complete information and answers.
Ask about treatment complications.
Ask about non-drug focused treatments for diseases and conditions.
Do not fall prey to the glitzy ads.
Be guided by a trusted physician; while insisting on complete information.

It is old hat in the medical device and drug industry; do not ask for permission—simply deal with the fall out of asking for forgiveness.

The US Attorney’s Office announced indictments against a number of Stryker executives for lying to the Food & Drug Administration. Apparently, Stryker was given permission for “limited humanitarian” use of its bone growth products, OP-1 implant and OP-1 Putty, used in spinal and long bone surgeries.

The Stryker products were only supposed to be sold in limited quantities and were only approved for use in treatment of certain rare diseases. It may be hard to believe that Stryker reportedly invented a number of other uses for these products and promoted them to physicians.

Stryker is one of the companies, together with Breg and IFlow, who are being sued over doing this same thing with pain pumps. It has become clear in the pain pump litigation that manufacturers knew that the FDA would require clinical trials (and resulting cost overhead for the manufacturer) in order to promote the use of pain pumps directly into joint spaces. Although manufacturers knew that use of the pumps in the joint spaces was prohibited without prior clinical trials, they promoted that use to physicians anyway. In fact, some of the manufacturers went so far as to promote the use and also promote methods that would allow for higher charges if the pain pump was used the way manufacturers were promoting it.

Now, these same manufacturers are trying to argue in the pain pump litigation that no good scientific studies exist that supports the causal relationship between pain pump use in joint spaces and a devastating condition called chondromalacia. Effectively, manufacturers are trying to convince judges to dismiss lawsuits based on their violation of the FDA requirements and their failure to conduct the scientific studies which the FDA would have required had the manufacturers complied with the law.

So, when selling potentially dangerous drugs and medical devices, apparently the theory is do not ask for permission; reap the profits; and pay for forgiveness later.

Levaquin (also known as levofloxacin) is a popular antibiotic that has been used for years for the treatment of upper respiratory infections, urinary tract infections, prostatitis, and bacterial infections.  It is part of a class of drugs known as fluoroquinolones, which were first marketed in the United States in 1997.  The fluoroquinolone class of drugs also includes the widely-prescribed antibiotics Cipro, Floxin, and Noroxin.  There have also been some notable fluoroquinolones that have been withdrawn from the market due to safety concerns, including Trovan (liver failure); Omniflox (low blood sugar; kidney failure, and anemia); Raxar and Zagam (prolonged QT syndrome); and Tequin (severe blood sugar reactions).

For several years, there have been rising concerns about adverse events associated with use of fluoroquniolones, especially Levaquin.  According to documents filed in the Levaquin litigation, being coordinated in the United States District Court in Minnesota, the Japanese company (Daiichi Pharmaceutical Co. Ltd.) that developed both Levaquin and Floxin knew prior to approval of Levaquin for sales in the United Sates that the drug was likely to cause Achilles tendon ruptures . This risk was well documented in the early years after introduction as it was marketed throughout Europe and began to cause harm to patients.

The warning label for Levaquin has included mention of the possibility of tendon ruptures in the past, but such labels were obscure and never adequately warned patients or prescribing physicians of the magnitude of the risk or the fact that Levaquin was more toxic than other, similarly effective drugs.  Other than placing a warning in December of 2001, based on postmarketing surveillance reports in the PDR, indicating that this risk may be increased in patients receiving concomitant corticosteroids, especially in the elderly, the manufacturer did not provide any special label precautions. The manufacturer fell far short in their warnings, regarding the higher risks faced by older patients or those concomitantly taking steroids.

This is most unfortunate because deleterious effects of fluoroquinolones on tendons have been well documented since the 1980s .

Finally, in 2008, after more than 1,000 reports of serious tendon injuries and ruptures to the FDA, a Black Box warning (the highest level of warning) appeared on the label confirming that patients taking Levaquin are at greater risk for suffering a ruptured Achilles tendon.   Unfortunately, the label still fails to alert physicians and patients that Levaquin is more toxic than other similar drugs .

Levaquin is particularly risky for patients who are over the age of 60 and taking corticosteroids at the same time as Levaquin.  Studies conducted by the manufacturer  indicated that Levaquin was more toxic than Cipro; for example the study that Ortho McNeil completed in 2001, one that Johnson & Johnson completed in 2006 and another By Johnson & Johnson completed in 1993. Unfortunately, none of the studies conducted by these manufacturers were published in any noted journals . Undoubtedly, if this information were known to physicians in the Untied States, prescribers would have evaluated the risk differently and chosen one of a number of other antibiotics for treatment of their patients. As a result, doctors might have avoided subjecting their patients to the unnecessary pain and suffering associated with an Achilles tendon rupture and a host of other adverse events.

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