May 14, 2012
Are pharmaceutical companies engaged in criminal behavior and cover-ups that threaten your health?
A recent Public Citizen report (www.publiccitizen.org) revealed that to date, drug companies have drawn False Claims Act penalties of nearly $20 billion, a majority of which occurred during the last five years. That amount will continue to escalate in the years ahead because there is no current evidence that Big Pharma has changed it ways:
- Multinational Big Pharma giant, Pfizer, paid out a settlement in excess of $2 billion for illegally marketing Bextra®, a painkiller that has since been discontinued.
- Three other companies joined Pfizer in paying out fines for illegal activities: Eli Lilly, GlaxoSmithKline, and Schering-Plough. This Big Pharma triumvirate has paid out a combined $10.5 billion in fines during the last two decades. Such penalties are small potatoes compared to drug company profits.
- Recent reports suggest that multinational pharmaceutical giant GlaxoSmithKline (GSK) tampered with clinical trial data in order to gain FDA approval of their diabetes drug, Avandia®. Evidence suggests that GSK was aware that the drug carried significant health risks. For example, studies found a 43% increased risk of heart attack and a 64% higher risk of cardiovascular death compared to patients treated with other methods. According to a Senate Finance Committee report, Avandia® has already caused more than 83,000 heart attacks.
- The recent heparin scandal involving a blood thinner manufactured by Baxter International, a company that outsourced production of the drug to enhance its profit, underscores an egregious lack of quality control and oversight by Big Pharma. Baxter failed to conduct its own inspections to ensure safe manufacturing practices and as a result, the use of this contaminated heparin was linked with 81 deaths and 785 severe allergic reactions in the U.S.
- A widely prescribed drug, Plavix® (Bristol-Myers Squibb), is used to help prevent strokes and heart attacks. Studies have revealed that Plavix® causes serious side effects you’ve probably never heard about. Shockingly, one study found that when combined with aspirin, Plavix® nearly doubled the death rate from heart disease among patients who had not had heart attacks but were at increased risk for them. The FDA has issued multiple warnings to Sanofi-Aventis and Bristol-Myer Squibb demanding that they correct their misleading statements and stop promoting unproven uses of the medication.
- Merck, the maker of the painkiller, Vioxx®, that killed 60,000 people (as many as were killed in the Viet Nam war!) ignored research that warned of the drug’s health risks and they concealed heart attacks suffered by three patients during a clinical trial published in the New England Journal of Medicine (NEJM) in 2000. Merck also deleted other potentially damaging data before submitting their article for publication to NEJM. I’ll have more to say about questionable practices and ethics of NEJM—considered to be the sine qua non of medical journals for practicing physicians—in future post on how medical media distortions affect your health.
- Wyeth, (now owned by Pfizer), paid ghostwriters to write articles promoting hormone replacement therapy (HRT) and instructed them to downplay its risks for medical journals. Judging from a shameful history of numerous lawsuits and settlements, it appears that drug companies aggressively developing and marketing drugs even when they know they will cause harm. They continue to do this because they know they are unlikely to suffer much of a consequence for their crimes. In cases where blockbuster drugs are at stake, they can calculate their potential liability when the inevitable lawsuits are filed and determine if the financial rewards in selling a lucrative drug outweigh the financial risks from lawsuit settlements.
In a rare public excoriation of Big Pharma, the Journal of the American Medical Association (JAMA) published the incomplete results of a drug trial cut short along with a derisive editorial reproving the drug manufacturer for calling off the study. The study was originally designed to determine whether the high-blood pressure drug Covera®, known generically as verapamil, was as effective as two other hypertension drugs at preventing heart-related complications of high blood pressure.
The clinical trial, which began in 1996, enrolled 16,602 patients with high blood pressure in 15 countries and was halted in 2000, two years early. Pharmacia (recently purchased by drug giant, Pfizer) called off the study for “commercial reasons” before researchers could determine whether the drug provided any benefits. JAMA editors have called trial’s halt unethical because study participants were deprived of personal benefit and that Pharmacia had a certain moral responsibility and social duty to uphold. The company had already invested $50 million in the study when it abruptly terminated the study, so you know something went terribly wrong. Study participants had been receiving their medications at no coast and were receiving medical care for hypertension, however those benefits stopped along with the trial. Studies have shown that verapamil has been linked to neonate deaths, liver damage, and other catastrophic adverse events.
The company broke a covenant with volunteers in the trial, who “were not only deprived of personal benefit … but also the social benefit of genuine scientific contributions,” wrote the co-authors of the editorial, Dr. Bruce Psaty of the University of Washington and Dr. Drummond Rennie, a deputy JAMA editor.
Some drug studies are terminated early when investigators deem that a drug’s benefits or risks make completion of the study dangerous or unethical. In this case, however, the results were not known before the study was ended. Importantly, results from the study could have been beneficial to millions of people worldwide who suffer from hypertension, but since the trial was stopped before researchers could accurately compare the drugs, there’s no telling what the outcome would have been.
A number of books written for a lay audience deal with Big Pharma corruption, criminal prosecutions, and judgments levied by our courts against Big Pharma for cover-ups, fraud, lying, and misleading physicians and the general public.
For additional opinions on these topics, follow these links:
Black R, Elliot WJ, et al. Principal results of the Controlled Onset Verapamil Investigation of Cardiovascular End Points (CONVINCE) trial. JAMA. 2003 Apr 23-30; 289(16):2073-82
Psaty B, Rennie, D. Stopping medical research to save money: a broken pact with researchers and patients. JAMA. 2003. Apr 23-30; 289(16):2128-31
☆ Disclaimer: This is my informed opinion. I could be wrong. What do you think?
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