Anyone who has been injured by a medication or medical device – or knows someone who has – is well aware that these products are not always as safe as they seem. Big Pharma purposefully and consistently keeps the American public in the dark regarding its drugs and medical devices, hiding negative studies that could discredit their products.Dangerous drug lawyers reveal this practice of so-called “publication bias.”
Half of all clinical trials, studies that measure the safety and efficacy of drugs and medical devices, are never published. Furthermore, the studies that result in negative or unpromising results are significantly more likely to remain hidden. This is the practice known as publication bias, and it is exponentially affecting what we know about the drugs we are prescribed.
These studies are not just hidden from public view; they are hidden from doctors and other researchers as well. Without full safety and efficacy data, doctors are forced to merely guess at which drugs and devices are best for their patients. These blind decisions often have devastating consequences for the patient, who suffer life-threatening or fatal complications from a drug they should not have been prescribed.
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In effort to make all clinical trials public knowledge, the Institute of Medicine recently published a report, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks. In this report, the IOM concludes that sharing data is in the best interest of the public and the current practices are unacceptable. To compile the report IOM assembled a committee to develop principles and framework to improve how we share trial data.
It should be normal practice to share data at the end of each clinical trial, researchers need to plan and document how their data will be usable to others who need it. This is literally a matter of life and death for so many people, data sharing needs to become an essential step in running a clinical trial.
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Companies like Johnson & Johnson, Novartis, Medtronic, and GlaxoSmithKline are currently the gatekeepers of their own data. For its part, the FDA needs to release more data they have from the drug approvals processes. The FDA holds more data than anyone else in the drug industry – their European counterpart, the European Medicines Agency, already publishes its data.
Recent FDA Actions
One of the most glaring recent consequences of undisclosed data concerns transvaginal mesh medical devices. These mesh products are implanted in women suffering from pelvic organ prolapse (POP) or stress urinary incontinence (SUI), however, they carry immense risks without any evidence of benefit.
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The FDA recently issued a warning that transvaginal mesh products (TVM) were associated with serious side effects including mesh erosion through vaginal tissue, infections, bleeding, organ perforation, and urinary problems. Thousands of women have had to be hospitalized and undergo additional surgeries to treat TVM complications or have it removed completely. For many patients, however, complete removal is impossible.
The FDA is telling doctors to fully inform their patients of potential TVM complications and consider all other treatment options. This takes us back to the crux of the issue: if neither doctors nor patients have access to full TVM data, how can anyone make a fully informed decision? 100,000 women were implanted with a TVM in 2010 alone; none of them knew the how great of a risk they were taking.
In this particular case, women have been able to file TVM lawsuits against the companies that misled them. Our team ofTVM lawyers is currently representing women who have been seriously injured by these and many other dangerous medical products. If you or someone you love suffered a serious side effect from a drug or medical device, contact our firm immediately. Our legal consultations are always free, and we do not charge any attorneys’ fees unless we win you a settlement or verdict.