House Democrats Propose Legislation to Require Drug and Medical Device Manufacturers to Disclose Results of All Human Clinical Trials
August 11, 2012 (PRLEAP.COM) Business News(New York, NY, August 11, 2012) The Rottenstein Law Group, which represents clients whose children were born with birth defects allegedly caused by the antidepressant Paxil, supports four members of the U.S. House of Representatives for proposing legislation that would require drug and medical device manufacturers to register with, and report the results of all human clinical trials to, ClinicalTrials.gov, a publicly-accessible federal database.
A group of House Democrats led by Rep. Edward Markey (D-Mass.) on August 2nd introduced the Trial and Experimental Studies Transparency (TEST) Act of 2012 (H.R. 6272), legislation that "updates and expands the clinical trial registry data bank-ClinicalTrials.gov-with stronger reporting requirements," according to a press release dated that same day.
The TEST Act would make ClinicalTrials.gov a more valuable resource by requiring drug and medical device manufacturers to, among other things: (1) register with ClinicalTrials.gov all interventional biomedical studies on humans; and (2) post the results from these trials on ClinicalTrials.gov within one year of the trial's completion, according to the August 2, 2012, press release.
These requirements have become necessary because drug and medical device manufacturers sometimes "hide negative study results, while emphasizing the positive ones," thereby "putting people unnecessarily at risk," according to Rep. Markey's press release. "High-profile examples included Paxil®, Avandia®, and Vioxx®, trials where safety concerns and negative results were suppressed by the drug companies," the press release says.
As advocates of patients who allege that they or their children suffered serious harm as a result of Paxil, a drug that Rep. Markey cites as having been the subject of suppressed clinical trials, the Rottenstein Law Group is in favor of legislation that, like the TEST Act, would require the disclosure of the results of all clinical trials on human participants.
The Rottenstein Law Group urges anyone who has suffered adverse side effects from Paxil or another prescription medication to speak to a qualified personal injury lawyer as soon as possible. The firm maintains a Paxil Lawsuit Information page at www.rotlaw.com/paxil. The page has features that allow for easy social media sharing, including links for automatic posting on Facebook and Twitter, which allow visitors to easily spread the word about the dangers of Paxil. (Attorney advertising. Prior results do not guarantee a similar outcome.)
About The Rottenstein Law Group
The Rottenstein Law Group is a New York-based law firm that represents clients nationwide in mass tort actions. The firm was founded by Rochelle Rottenstein, who has more than two decades of experience as a lawyer, to represent clients in consumer product injury, mass tort, and class action lawsuits in a compassionate manner.