The Washington Post article, “As drug industry’s influence over research grows, so does the potential for bias” by Peter Whorisky is an eye-opener on how pharmaceutical funded research is tailored to benefit the industry rather than reveal reality (Whoriskey, 2016). Various examples were cited in this article, like: The New England Journal of Medicine (NEJM) published a work that compared the benefits of four diabetic drugs and found that the new drug Avandia (made by GlaxoSmithKline), was the best among the four (Kahn et al., 2006). The study was funded by GlaxoSmithKline. According to Whoriskey, this study was biased in suppressing the harmful effects of Avandia. FDA approved the drugs, but the drug was later withdrawn from the market as it was found dangerous. While Avandia was found safe in clinical trials, after its release, the drug was associated with harmful effects in those who consumed it. Avandia increases the risk for heart attack in the patient.
The study that was published in NEJM compared the effects of thiazolidinedione, rosiglitazone (Avandia, GlaxoSmithKline), metformin and sulfonylurea in reducing blood glucose level and not its effect on heart attack. The patients in this study were recruited between a two-year period from 2000 to 2002. The patients were treated for four years and this is a reasonable amount of time for the expression of drug associated adverse effect. According to this study, death from cardiovascular event was highest with Avandia, though in comparison to Metformin and Glyburide, it was not statistically significant. Probably the difference was clinically significant. The researchers have indeed reported the highest number of cardiovascular associated deaths in rosiglitazone (Avandia). Hence the claim that the research funded by pharmaceutical company is biased, may not be completely correct. Exhaustive research study is required to confirm the safety of a drug. In most cases it takes longer period. The inefficiency and lack of sensitivity of the research methodologies and techniques that existed during the period could be a reason that favored the entry of Avandia into the market. The FDA could have sought for more exhaustive studies before approving the drug. Thus, the claim that research is biased, may not be correct in this case. It is an assumption made by Whoriskey in the light of the events. Though the author has a predisposition for critical analysis, his claims are not based on a comprehensive analysis and evaluation. The study did report harmful effects of Avandia, like edema and high LDL cholesterol in the patients. Why were these negative effects overlooked and the drug approved by the FDA? FDA approved the drug ignoring the warning given by Cleveland Clinic cardiologist. FDA has taken a biased stance, while the research done on the drug did not express any bias as suggested by the author.
The literature support provided in the article, does not back the claim that research funded by pharmaceutical is biased. Nevertheless, there could be a possibility that GlaxoSmithKline has made an effort to promote the drug, ignoring the side effects seen in research. However, there is no clear evidence to support if this effort was done intentionally or unintentionally. The FDA and the pharmaceutical industry, have ignored the side effects of the drug. Further, it is irresponsible on the part of FDA to approve a drug without complete assessment of its safety. FDA cannot approve a drug that is not tested exhaustively using animal and clinical trials. The drug was not lifesaving as there were already other drugs in the market to tackle the problem and thus FDA could have waited till the drug was found completely safe.
Conclusion: The research article published in the NEJM did not show a bias towards Avandia. It has identified an increased number of deaths from cardiovascular diseases in the Avandia group. Further, the study has also identified side effects like edema, high level of LDL and low hematocrit in the Avandia group. It did not try to suppress the side effects.
References:
Kahn, S., Haffner, S., Heise, M., Herman, W., Holman, R., & Jones, N. et al. (2006). Glycemic Durability of Rosiglitazone, Metformin, or Glyburide Monotherapy. New England Journal Of Medicine, 355(23), 2427-2443. http://dx.doi.org/10.1056/nejmoa066224
Whoriskey, P. (2016). As drug industry’s influence over research grows, so does the potential for bias. Washington Post. Retrieved 14 January 2016, from https://www.washingtonpost.com/business/economy/as-drug-industrys-influence-over-research-grows-so-does-the-potential-for-bias/2012/11/24/bb64d596-1264-11e2-be82-c3411b7680a9_story.html
