January 5, 2011 — The British Medical Journal and MedPage Today have raised awareness about the issue of medical research being suppressed. Some examples of products where important research was withheld are: Multaq, Avandia, Vytorin, Metronic Infuse Bone-Graft, and more. If you have experienced a side effect after using these products, you may have a Texas drug side effect lawsuit. Contact a Texas lawyer at The Clark Firm, LLP.
In a series published in the British Medical Journal, the investigators found that less than 50% of the studies conducted by the National Institute of Health (NIH) were published within 30 months after the studies were completed; after 51 months, the numbers had only risen to 66%, leaving one-third unpublished. Furthermore, 22% of studies of Food and Drug Administration (FDA) approved drugs had reported their results within one year. This is surprising, considering that there is a law requiring studies of FDA-approved drugs to be announced within one year.
The implications of unpublished research are that consumer are potentially exposed to drugs and medical products that are unsafe. Many of these people are now filing Texas drug side effect lawsuits against the drug companies.
The BMJ suggested that one solution would be disciplining researchers who intentionally withhold data. Professional organizations would be responsible for punishing doctors who decide not to make their results public.
Some possible reasons why so much research is going unpublished include:
- Drug-companies are motivated by profit, and they do not want harmful publicity from negative research to harm their profits.
- The researchers who conduct the clinical trials may get unintended results that contradict their academic beliefs. They may have personal or professional reasons for not wanting to publish the findings.
- The journals themselves may not want to publish negative information about certain drugs. They may also not want to publish research that they believe is flawed.
When valid research is not published or announced publicly, it is difficult for physicians to make informed decisions about the drugs they prescribe to their patients. Drug approval agencies may also lack the necessary information they need to determine whether a drug is safe. Over the last several years, there have been several scandals involving people and drug-companies withholding important safety information from clinical trials, prompting drug side effect lawsuits from people who were subsequently injured.
Vytorin: A drug prescribed to improve arterial health and reduce cholesterol, produced by the pharmaceutical company Schering-Plough. The company conducted a clinical trial of their drug, which found that it did not improve arterial health. Despite this information, the company did not announce the results of this study, and instead invested in a massive TV commercial campaign promoting the drug. A congressional investigation in 2008 revealed the scandal.
Multaq: This prescription medication is prescribed to treat “atrial fibrillation,” also known as irregular heartbeat. A study in 2003 compared Multaq with a placebo, and found that patients taking Multaq were more likely to die. The company waited for five years to publish this data.
Avandia: This is a medication prescribed for the treatment of Type-2 diabetes, produced by GlaxoSmithKline. An independent study conducted in 2007 found that patients who took Avandia were more likely to have a heart attack or cardiovascular problems. The researcher who conducted this study found that of the 42 studies of Avandia, 35 were never published. This research information was not made public until GlaxoSmithKline was sued in a drug side effect lawsuit, and a court forced the company to reveal the data.
Medtronic Infuse Bone-Graft: “Infuse” is a medical product created by Medtronic, used to stimulate bone growth in patients who have recently had back surgery. In a clinical trial of Infuse, the study had to be halted prematurely after volunteers experienced bone overgrowth. Some needed additional surgery to remove the overgrown bones. Even so, the results of this study were not published for five years.
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