The Funding and Publishing of Clinical Trials
Clinical trials and medical journal publications are seen as a check and balance system against big pharmaceutical companies as they supposedly provide an un-biased, independent analysis of peer reviewed data. However, it is becoming more evident that big pharmaceutical companies may have more say in both of these integral operations than consumers believe.
What Really Drives Pharmaceutical Company Funded Research?
“The decision to fund any further preclinical work will depend on the competitive advantage that the work can demonstrate for Seroquel. This is primarily due to the fact that R&D [Research and Development] is no longer responsible for Seroquel research – it is now the responsibility of Sales and Marketing.” – E-mail from AstraZeneca to Dr. Andrew Goudie, University of Liverpool
- Analysis of clinical trials funded by big pharmaceutical companies suggests that major drug companies are less concerned with maintaining a safe drug for their patients, and more concerned with how they may spin information in a way that increases marketability.
- According to a 2006 study, of 32 “non-bias” head to head studies in which pharmaceutical companies funded clinical trials comparing a drug they owned to competitor drugs, 90 percent of the time, results were found to be favorable for the company funding the trial.
- Even in clinical trials in which the same drugs were compared, the drug with more “efficacy” was that of the company funding the research leading to conflicting reports.
- While some allege this is due to companies over and under dosing competitor drugs in trials to make them seem too dangerous or less effective, Richard Smith, former editor of the British Medical Journal, states that this is “far to crude and possibly detectable by peer review.” Instead it is seems to be a matter of pharmaceutical companies asking “the right questions.”
- When unfavorable data does appear, it may be suppressed or go unpublished. In fact, GlaxoKlineSmith was sued by New York when evidence showed that the company deliberately hid two studies that showed Paxil increased the risk of suicide in children.
- This was also the case of AstraZeneca's Study 15, a precursor to the CAFE trials. This has lead to over 9,000 lawsuits being filed as patients were not properly warned of adverse effects of Seroquel including in increased risk of diabetes and other health risks, like suicide, which may lead to death.
Medical Journals as an Arm of Pharmaceutical Marketing and Sales
- It is currently estimated that company funded research makes up between two-thirds and three-fourths of all trials published in major medical journals including The Journal of the American Medical Association, Lancet, the New England Journal of Medicine and Annals of Internal Medicine.
- This has led to concern by medical journal writers and editors that major medical journals are losing their ethicality as they are seen as a marketing tool for pharmaceutical companies, more than independent journals.
- The editor of the Lancet, Richard Horton, has referred to the journals as becoming “information laundering operations for pharmaceutical companies.”
- It has also been suggested that pharmaceutical companies are able to sway medical journals the same way they are able to sway clinical trial investigators, with money. It is suggested that some editors may publish suspicion studies with the understanding that pharmaceutical companies will purchase thousands of reprints of the magazine.
- Thus, according to Richard Smith, it is “publish a trial that will bring in $100,000 of profit or meet the end-of-year budget by firing.”
Contact an Experienced Clinical Trial Attorney
Thomas J. Henry are leaders in the area clinical trial litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. Our Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.
If you or a loved one have been injured by or have developed serious side-effects while participating in a clinical trial, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.