U.S. report faults FDA oversight of drug trials

[Lone_Star_Dem]

Source: Reuters

WASHINGTON (Reuters) - A report to be released on Friday finds the U.S. Food and Drug Administration does very little to ensure the safety of patients who help test drugs in clinical trials, The New York Times reports.

It quotes Daniel Levinson, the inspector general of the Department of Health and Human Services, as saying FDA officials do not know how many clinical trials are being conducted and have audited fewer than 1 percent of the testing sites.

FDA inspectors often show up long after the tests have been completed, the Times quotes the report as saying.

HHS is the parent department of the FDA, which, among other duties, approves new drugs. Clinical trials -- those involving real human patients -- are a key part of this approval process.

Read more: http://www.reuters.com/article/domesticNews/idUSN2741830920070928?feedType=RSS&feedName=domesticNews&pageNumber=2

[Justiceleague]

1. Why The FDA Alone Cannot Protect Patience

Consumers and patients rely on both federal safety regulations and strong state remedies to safeguard public health. The Food and Drug Administration has been charged with assuring the safety, efficacy, and security of drugs and medical devices. When the FDA fails to meet this responsibility, injured patients have the right to hold drug and device manufacturers accountable through state remedies and the civil justice system.

Federal preemption of state remedies, as seen in the FDA’s recent drug warning label rule, strips away the safety net of state remedies. Recent FDA failures demonstrate that the federal regulatory process must be supplemented by state remedies in order to fully ensure the safety of American families.

FDA has consistently failed to warn the public about dangerous prescription drugs. The FDA is not required and often does not elicit independent information on the safety and effectiveness of drugs - either before they enter the market or after. By not proactively requesting additional data, pharmaceutical companies may choose to distort, manipulate, and even conceal results from clinical studies for faster drug approval.
• Avandia – The New England Journal of Medicine recently released findings which showed this diabetes drug significantly increased the risk of heart attacks, when compared with a placebo or other diabetes drugs. However, both the drug maker and the FDA knew about signs of potential cardiovascular risk for at least five years but failed to warn patients of the risks.
• Paxil – The FDA’s nondisclosure policy allowed GlaxoSmithKline to conceal clinical trial results linking Paxil to an increased risk of suicidal tendencies among adolescents. Then New York Attorney General Eliot Spitzer’s lawsuit, not the FDA, ultimately exposed the manufacturer’s selective disclosure of negative drug data.

FDA has consistently failed to ensure the safety of newly marketed prescription drugs and medical devices. The Journal of the American Medical Association estimates that every year, about 701,000 individuals are treated for Adverse Drug Reactions (ADRs) in emergency rooms. Over half of all approved drugs have serious post-approval risks, often undetected by the FDA until several years after being marketed to the public.
• ReNu MoistureLoc Lens Cleaner – Despite earlier warnings linking blinding eye infections to ReNu Lens Cleaner by Hong Kong and Singaporean health officials, the FDA still approved ReNu for American use. Four months passed before American government officials learned about stateside fungal infections from a private New Jersey doctor who shared his findings with the CDC.
• OxyContin – The FDA’s decision allowing Purdue Pharma to claim that the time-released nature of OxyContin “is believed to reduce” its potential abuse contributed to the manufacturer’s false claims regarding the drug’s highly addictive nature.

FDA has consistently failed to require drug efficacy and safety data on women and children, even when prescription drugs are marketed for these populations.
• More clinical trials testing children – The GAO reports that only 33% of all drugs prescribed for kids are studied and labeled for pediatric use. Kids have differing metabolisms, growth, and development than adults, and may be adversely impacted by prescription drugs tested only on adult populations. Given the lack of available clinical data on drugs used by children, the FDA needs to issue more written requests for drug sponsors to conduct pediatric drug studies.
• More clinical trials testing women - In 2005, results from a 10-year study on Aspirin indicated that the risk of increased bleeding and strokes outweighed any health benefits of the painkiller in middle aged women. The results also demonstrated that certain drugs marketed for both men and women may impact women differently than men, due to physical differences in hormones, heartbeat speed, and body fat percentage. The FDA should require greater female participation in clinical trials for drugs marketed to women.

FDA has consistently failed to enforce the post-market surveillance requirements of newly approved drugs. Even when the FDA has requested additional post-market studies of newly approved drugs, the agency hardly enforces drug sponsors to complete these studies. One study featured in a 2006 GAO report estimates that between 1991 and 2003, only 24% of FDA requested post-market studies were completed annually.
• Arava – Sanofi-Aventis failed to complete a post-approval study on the arthritis drug Arava after the FDA questioned the drug’s long term safety in 1998. In 2003, the FDA kept staff members from presenting an unfavorable analysis of Arava. Two years later, fatal liver complications have been reported by those using the drug.
• Trasylol – The American Medical Association estimates that Trasylol causes 2,000 unnecessary deaths annually. However, the FDA only began conducting a safety review of Trasylol after two published research studies reported an increased risk of kidney failure, heart attack, and stroke in users. Furthermore, the FDA’s safety review process failed to uncover harmful data known by Bayer until the drug manufacturer submitted the data.

Pervasive conflicts of interest among FDA advisory committee members have compromised the safety of marketed prescription drugs. The FDA allows pharmaceutical companies to unduly influence the drug approval process. Though the agency’s own experts were not permitted to participate in 2005 advisory committee meetings on Bextra and Vioxx, ten panel members with conflicts of interest were granted FDA waivers to discuss the safety of these drugs.
• The conflicted members, who had accepted money from Bextra and Vioxx manufacturers, favored marketing these drugs in 28 out of 30 votes.
• If these conflicted members had not been allowed to vote, Bextra would have been removed from the market, and Vioxx would have stayed off the market.
• Merck finally withdrew Vioxx after an estimated 27,000 deaths resulted from the drug’s increased risk of heart attack and stroke.

[Lone_Star_Dem]

2. Welcome to DU, Justiceleague!

That is one amazing first post! :hi: