- There have been numerous lawsuits against pharmaceutical companies for drug safety violations.
- In a lawsuit against GSK in 2012, the company pled guilty for failing to report safety data and unlawfully promoting three drugs.
- The pharmaceutical industry’s history of drug safety violations raises legitimate questions about the safety of vaccines.
In July 2012, British pharmaceutical company GlaxoSmithKline LLC (GSK), agreed to plead guilty to criminal and civil charges resulting from the company’s failure to report safety data about the drug Avandia and unauthorized promotion of the drugs Paxil and Wellbutrin making this the largest healthcare fraud settlement and largest payment ever made by a pharmaceutical in U.S. history.1 This case exemplifies the reasons for public distrust in the pharmaceutical industry, particularly regarding vaccines.
The Case of Avandia: Failure to Report Safety Data
Avandia, a drug prescribed to patients for Type 2 diabetes, triggered thousands of lawsuits in the U.S. against GSK for its serious cardiovascular side effects in 2010.2 According to an investigation led by the U.S Department of Justice, GSK failed to include certain safety data about Avandia in reports to the U.S. Food and Drug Administration (FDA) that are intended to allow the FDA to determine if a drug continues to be safe for its approved purposes and to identify drug safety trends.1
The information that was not provided by GSK included data from post-marketing studies and data from two studies conducted as a result of concerns by European regulators regarding the cardiovascular safety of Avandia.1 The clinical trial findings showed that more people died as a result of a cardiovascular event while taking Avandia than those taking a placebo. Despite these findings, Avandia’s black-box warning label failed to mention an increased risk of congestive heart failure and myocardial infarction (heart attack) until the FDA warned about the risks in 2007.1 2
A lengthy investigation by the U.S. Senate Finance Committee revealed that GSK was well aware of the cardiovascular dangers associated with Avandia for years and dismissed concerns reported by several doctors about the drug.1 2 3 GSK pleaded guilty for failing to report Avandia’s safety data to the FDA.1
Fast-forward to 2013, the FDA decided to lift the safety restrictions on Avandia stating that recent research analysis shows that the drug does not increase the risk of heart attacks.4 Dr. Steven Nissen, chair of Cleveland Clinic’s Department of Cardiology, whose research first raised concerns about Avandia states that the announcement…
about the FDA’s effort to save face. This is about appearances, not changing medical practice. A single reanalysis of a trial does not exonerate a drug where all the other data point to increased cardiovascular risks.4
The Case of Paxil and Wellbutrin: Misbranding and Wrongful Labeling
Between 1998 and 2003, the U.S. government alleged that GSK illegally promoted Paxil for depression for patients under the age of 18 despite the fact that the FDA never approved the drug for pediatric use.1 According to the Office of Public Affairs:
GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy. At the same time, the United States alleges, GSK did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18. The United States further alleges that GSK sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents. GSK paid a speaker to talk to an audience of doctors and paid for the meal or spa treatment for the doctors who attended.1
Furthermore, between 1999 and 2003 another drug Wellbutrin had only been approved by the FDA for Major Depressive Disorder, weight loss, treatment if sexual dysfunction, substance addictions, Attention Deficit Hyperactivity Disorder and a few other uses; however, the U.S. Department of Justice found that…
GSK paid millions of dollars to doctors to speak at and attend meetings, sometimes at lavish resorts, at which the off-label uses of Wellbutrin were routinely promoted and also used sales representatives, sham advisory boards, and supposedly independent Continuing Medical Education (CME) programs to promote Wellbutrin for these unapproved uses.1
GSK pled guilty to the misbranding and false labeling of both drugs.1
Pharma’s Track Record Has Led to Distrust in Vaccine Safety
The FDA and the pharmaceutical industry have repeatedly proven themselves undeserving of the public’s trust. The case of Avandia, Paxil and Wellbutrin is only one of hundreds of lawsuits against pharmaceuticals for failing to disclose the risks associated with certain drugs. Yet drug companies continue to make profits off of these unsafe medications.
While the pharmaceutical industry is a business enterprise and the primary goal of all business enterprise is to maximize profits, there is legitimate cause for concern when it comes to products that we consume and inject into our bodies when they are poorly regulated for safety. The misalignment between the financial interests of the pharmaceutical industry and that of government’s public health agenda can end up endangering our health.
Hundreds of lawsuits against drug companies have exposed Pharma’s unethical practices. The industry lacks integrity and transparency on many fronts, including manipulation of clinical trials, hiding and minimizing the side effects of drugs, bribing doctors, etc. How can the public trust that vaccines are safe when the very same manufacturers have been guilty of fabricating the truth about the safety of prescription drugs?
In fact, vaccine production is the fastest growing segment of the pharmaceutical industry and creates a huge incentive for the industry to maximize profits at any expense. Moreover, Congress and U.S. Supreme Court have shielded vaccine manufacturers from product liability so that vaccine-injured victims have no way to sue them in civil court in jury trials.5
Furthermore, while the role of government regulators such as the FDA is to ensure safety and protect the public from any potential harm from pharmaceutical products, Pharma-government financial conflicts of interest are more rampant than ever and pose a threat to public safety.6
Pharma, government agencies, medical trade groups, etc. all pursue their own agendas, leaving the public to wonder who to really trust when it comes to evaluating the benefits and risks of vaccines and other pharmaceutical products.
1 U.S. Department of Justice. GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data. Justice.gov July 2, 2012.
2 Avandia Lawsuit. DrugWatch Mar. 1, 2017.
3 Silverman E. Supreme Court says Glaxo must face racketeering lawsuits over a diabetes pill. StatNews June 6, 2016
4 FDA Reverses Course on Avandia warning, lifts safety restrictions. CBS News Nov. 25, 2013.
5 Fisher BL. No Pharma Liability? No Vaccine Mandates. NVIC.org Mar. 2, 2011.
6 La Vigne P. Pharma-Government Conflicts of Interest Exposed. The Vaccine Reaction Feb. 10, 2015.