Bloomberg reveals that during the 2010 midterm elections, big oil and big pharma spent millions of dollars to help elect Republicans to Congress through attack-ads. The Supreme Court’s 2010 Citizen’s United decision paved the way for virtually unrestricted corporate campaign spending, in this case to fund politically active groups like Americans for Prosperity. According to Think Progress, a blog of the Center for American Progress Action Fund, Chevron’s profits have jumped 23.3 percent since its 2010 controbutions.
Finding a Cure for “Pharmacosis”
“What is the difference between a doctor and a pilot?” Dr. David Healy asked during a recent talk at the CUNY Graduate Center. The answer? A doctor isn’t going to go down with you.
Healy, a psychiatrist, psychopharmacologist and scientist, is the author, most recently, of Pharmageddon, a book about the “hijacking” of American healthcare by the pharmaceutical industry and what can be done about it. During his talk, Healy observed that doctors, not patients, are the consumers of medicine. And because doctors, unlike pilots, are not going to be personally affected by every professional decision they make, they may be less critical of “evidence” put forth by pharmaceutical companies, and more willing to overlook potential risks associated with the drugs they prescribe.
Healy argues that we have become too comfortable with the randomized control trial as our only source of drug evaluation. Evidence from clinical trials now trumps the values of patients and the expertise of doctors, despite the fact that, in Healy’s opinion, these trials have become mechanical and thoughtless. Because of dependence on control trials, prescription drugs are seen as innocent until proven guilty, and the pharmaceutical industry, rather than doctors, is playing an increasingly large part in curing disease.
In Pharmageddon, Healy cites examples of clinical trials that showed significantly different evidence of a drug’s effects than were actually published. “The unpublished trials primarily are negative,” he said in his talk, but pharmaceutical companies have strategies for turning negative trials into positive reports. Healy pointed to Eli Lilly’s Prozac trials from 1986. Data on suicides and suicidal acts while on Prozac were compared to the same events on placebo, no drug, or older drugs. For U.S. trials, Eli Lilly listed four suicides on Prozac and one on placebo, as well as 26 suicide attempts on Prozac and nine on other treatments. The corporation took this data and discounted seven of the nine suicide attempts on Prozac as non-genuine, while none of the placebo attempts were discounted. Four of the nine suicide attempts on placebo were in patients who had recently discontinued fluoxetine treatment (fluoxetine is the generic name for Prozac). Ultimately, the data that ended up in a 1991 BMJ article that reported on these trials looked quite different from the original 1986 data. Healy goes into further detail on this and other examples in Pharmageddon and on his blog.
“When the range of ways the suicide data were handled by Eli Lilly in this case or other companies in other cases do come up,” he writes, “companies tend to portray themselves as not statistically sophisticated. The implication is that if things went wrong, they did so by accident.” Accident or not, there is a lack of consistency between what the literature says and the trial results. Healy calls this the greatest divide in all of medicine.
Because of our dependence on randomized control trials and resulting uncritical acceptance of new drugs, we are suffering, according to Healy, from a new disease he calls “Pharmacosis.” One thing we can do to prevent the spread of this disease is to shift from evidence-based medicine to data-based medicine. We can do this by providing access to the data from randomized control trials, not just to the published reports.
We also need to give greater weight to anecdotal evidence. Currently, doctor and patient observations of drug effects are disregarded, despite the fact that most of these observations turn out to be correct. Though reports of adverse events from taking a drug may be anecdotal, Healy believes that it is still important for the system to pay heed and change as a result. This is why Healy has started www.RxISK.org, a patient adverse event reporting system. Through this website, patients can enter side effects they are experiencing from a particular drug, learn more about that drug, and view how many other people in their area are experiencing similar effects. People experiencing adverse events from a particular drug may believe that they are isolated, but this system will allow them to see whether others are having similar problems, and ideally mobilize them to do something about it.
In a video clip on Rxisk.org, Maria Bradshaw, whose son died by suicide 15 days after taking Prozac and experiencing a range of adverse reactions, discusses how sharing these reactions is important. She says that the trial populations pharmaceutical companies use to test their drugs are not representative of people who actually take them. “The only way that we’re actually going to learn about how these drugs work on people in the general population is for people like me and everyone else out there who’s using these drugs to file adverse reaction reports,” she urges. Healy’s hope is that people will use Rxisk.org to do just that, giving us a mechanism besides control trial reports through which to judge drugs, ideally reversing the effects of Pharmacosis.
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FDA May Ban Antibiotics in Livestock Feed
The Jurist reports that the U.S. District Court for the Southern District of New York has issued an order to the FDA to continue proceedings, begun in 1977, that could lead to the removal of penicillin and tetracycline from agricultural livestock feed. If companies are unable to demonstrate that these antibiotics are safe, the FDA must prohibit their inclusion in feed. As Gardiner Harris writes in the New York Times, use of antibiotics in livestock feed can lead to the growth of antibiotic-resistant “superbugs,” a significant public health concern.
Indian Government Ends Bayer’s Monopoly on Cancer Drug
The Indian government will allow a local company to manufacture a generic version of the cancer drug Nexevar, which is currently patented by Bayer. A Common Dreams post explained that the the government’s ruling is based on a trade law that gives the government power to allow the manufacturing of generic versions of otherwise unaffordable drugs. It enables Natco Pharma to create a version of Nexevar that will cost $176 for 120 tablets. Bayer was charging about $5,600 for the same amount. Bayer spokeswoman Sabina Cusimano told the Associated Press, “We will see if we can further defend our intellectual property rights in India.”
Occupy Wall Street Visits Pfizer
Occupy Wall Street protesters marched around midtown Manhattan on Wednesday, February 29, chanting anti-corporate slogans outside banks and the pharmaceutical giant Pfizer, reported the Wall Street Journal. Protesters awarded Pfizer a prize for “Excellence in Profiteering,” noting the discrepancy between the wealthy pharmaceutical company and the millions of uninsured Americans who cannot afford health care.
Patients Say FDA Lets Big Pharma Create Artificial Drug Shortages
Two dozen people suffering from life-threatening Fabry disease, a rare condition caused by deficiencies in an enzyme needed to metabolize lipids, say the U.S. Food and Drug Administration and the Department of Health and Human Services give drug manufacturers carte blanche to create drug shortages that deny them the medicine that keeps them alive, reports Courthouse News. Twenty-five people sued the agencies in Federal Court on constitutional claims. Most of the plaintiffs say they are being denied interstate access to Fabrazyme, a drug that treats Fabry disease, due to a shortage created by Genzyme, the drug’s manufacturer, but not a party to the case. They seek an injunction ordering the government to take the enforcement actions and they want the drug companies to disgorge profits unjustly created by drug shortages and fined for creating shortages.
Pharma Looks for Digital Marketing Edge
At the recent ePharma Summit in NYC, Charlotte McKines, Global Vice President, Marketing Communications and Channel Strategies, Merck & Co, spoke on “How Digital is Transforming the Pharmaceutical Marketing Model.” She noted, “Customers are increasingly looking for information using digital to get information so you see… most of our customers, physicians, use the web to gather information, but more importantly they use the non-pharmaceutical sites to get information about our products. They really don’t have a lot of trust and value right now in pharmaceutical sites. So we really struggle… to really become a primary trusted source. We have got to get there because finding the right place and being in the right destination for our customers really does give us the competitive advantage.”
Johnson & Johnson to Pay $158 Million to Settle Lawsuit on Improper Marketing
The drug company Johnson and Johnson, according to the New York Times, last week said that it would pay $158 million to settle a 2004 Texas lawsuit that accused the company of improperly marketing Risperdal, an antipsychotic drug, to state residents on the Medicaid health program for the poor, including children. The lawsuit accuses the company of pushing Risperdal as “appropriate and safe to treat a broad range of symptoms in populations and disease states for which it had no F.D.A.-approved indication, including in the child and adolescent population.”
Altria: A Good Stock Buy for 2012?
The shares of Altria Group, the leading cigarette maker in the U.S., rose 20% in 2011’s flat market, and it’s up 50% over the past two years, nearly four times the market’s gain, reports Barron’s this week. Two weeks ago, the stock of Altria, the parent of Philip Morris USA, hit a 52-week high. But, warns Barron’s, investors have largely ignored the risks accompanying the domestic tobacco business. U.S. cigarette sales are in a severe long-term decline. Shipments are down by a third over the past 10 years. In 2011 alone, cigarette volumes fell an estimated 3.8%, reflecting the weak economy and an ever-growing public backlash against smoking. “Operating conditions in the U.S. cigarette industry are more difficult than generally recognized,” says David Adelman, long-time tobacco analyst at Morgan Stanley. He isn’t recommending any of the stocks.
The Champion of Pain Killers
Overdoses from painkillers now kill nearly 15,000 people a year and many experts doubt that they are effective in reducing long term pain. Yet a new investigation by Pro Publica, also published in the Washington Post, finds that an influential champion for painkillers is the American Pain Foundation, the nation’s largest advocacy group for pain patients. But 90% of the Foundation’s 2010 income came from the drug and medical device industry and its positions closely follow those of its corporate donors.
Corporations and Health Watch 