By Lara Berch
The number of people suffering from the side effects of pharmaceutical research is increasing all over the world. According to the article Deadly Medicine, more and more clinical trials are being outsourced overseas. It is cheaper to recruit patients, there are less stringent regulations in place (if any at all), no risk of litigation, and mainly the trials are barely monitored by the FDA. Apparently there is a loophole in the FDA regulations:
“if studies in the United States suggest that a drug has no benefit, trials from abroad can often be used in their stead to secure F.D.A. approval. There’s even a term for countries that have shown themselves to be especially amenable when drug companies need positive data fast: they’re called “rescue countries.”
FDA conducts no independent research and visits only a small number of locations where foreign trials are being conducted. That allows the companies conducting trials plenty of room to manipulate the results.
The hefty financial incentives are given to the doctors by the pharmaceutical companies for conducting research on humans regardless of the outcome – killing or curing.
Adriana Petryna, author of the book When Experiments Travel: “In Russia, a doctor makes two hundred dollars a month, and he is going to make five thousand dollars per Alzheimer’s patient” that he signs up.
In one of the poorest provinces of Argentina trials were conducted to test the new vaccine Synflorix (prevents pneumonia, ear infections, and other pneumococcal diseases) that was developed to compete with the old vaccine. As a result, 14 infants died. The parents of those infants are poor and illiterate and they did not know what they were being signed up for. The doctors that signed them up “reportedly received $350 per child”. The death of humans in pharmaceutical lingo is referred to as an “adverse event”. Similar “adverse events” have taken place in India where 49 babies died as well as in Poland where residents of a homeless shelter received $2 to participate in a flue vaccine experiment which was presented to them as a flue shot. 20 people died.
In those trials where the drug has proven to be ineffective, the results are often not disclosed to the public.
In the mid-90s, Glaxo conducted clinical trials on the antidepressant Paxil in the United States, Europe, and South America. Paxil is a member of a class of drugs called selective serotonin re-uptake inhibitors. The class includes Zoloft, Prozac, and Lexapro. In the United Kingdom, Paxil is sold as Seroxat. The clinical trials showed that the drug had no beneficial effect on adolescents; some of the trials indicated that the placebo was more effective than the drug itself. But Glaxo neglected to share this information with consumers; annual sales of the drug had reached $5 billion in 2003. In an internal document obtained by the Canadian Medical Association Journal, the company emphasized how important it was to “effectively manage the dissemination of these data in order to minimize any potential negative commercial impact.” The memo went on to warn that “it would be commercially unacceptable to include a statement that efficacy had not been demonstrated.” After the document was released a Glaxo spokesperson said that the “memo draws an inappropriate conclusion and is not consistent with the facts.”
According to Bloomberg News, Glaxo has spent about $390 million to settle Paxil suicide or attempted suicide lawsuits, $200 million to settle Paxil addiction and birth defect lawsuits and $400 million to resolve antitrust, fraud and design claims for a total of $1 billion.
From doing a quick search on Google, a common drug for the elderly, Miacalcin, has a price tag of $1128 for a yearly supply. According to the Pharmaceutical Industry’s statements, the reason for high cost of drugs arises form research and development that goes into producing it. From the data published in the PLOS, contrary to the industry’s claim, it appears that pharmaceutical companies spend almost twice as much on promotion and marketing as they do on research and development. For example in 2004, $57.5 billion was spent on promotional activities and 31.5 billion on research and development. Granted, the fact that the industry is driven by and for profit is not astonishing or surprising. What is astonishing is how this so called research and development is conducted and at what cost.
Sadly, the treatments and prescriptions that doctors recommend are rarely questioned by an average patient. After all the drugs are FDA approved. The death toll from FDA approved prescription drugs is around 300,000 per year, but this information never makes it to the news headlines. It is disturbing and uncomfortable information and until we start taking it personally, not much can be changed.
Until the headline news will continue to pacify us with America’s Next Top Model and Celebrity Gossip, we as a society will continue being human guinea pigs for the pharmaceutical industry.