Accident & Injury Law in Texas

Posts Tagged ‘FDA’

A federal drug official dealt a severe blow Friday to the popular diabetes drug Avandia, issuing a scathing review of a major clinical trial that its manufacturer has been using to argue that the drug was safe.

The reviewer, Dr. Thomas Marciniak of the Food and Drug Administration, found a dozen instances in which patients taking Avandia appeared to have serious heart problems that were not counted in the study’s tally of adverse events.

Such repeated mistakes “should not be found even as single occurrences” and “suggest serious flaws with trial conduct,” Marciniak wrote.

The detailed report could prove crucial next week, when a panel of experts meets to consider whether to recommend to the FDA that the manufacturer, GlaxoSmithKline, withdraw Avandia from the market or restrict its sale.

The panel’s decision will have broad consequences for the company, the FDA and perhaps even the entire process by which medical products are approved. The agency rarely does clinical trials on its own, depending on drug companies to conduct them appropriately.

Avandia, which helps patients get better control of their blood sugar levels, has already come under intense criticism. It has been shown to increase the risks of bone fractures and to cause swelling that can lead to heart failure and eye problems. And a number of studies, including some by GlaxoSmithKline, suggest that it could increase the risks of heart attack, stroke, and death.

GlaxoSmithKline has relied heavily on the major clinical trial, named Record, to demonstrate that those risks are exaggerated.

Marciniak’s review of the Record study calls that assertion into question. He found one case in which a seizure patient was hospitalized for bleeding in the brain, but all mention of the episode was deleted from records. Another patient was hospitalized for 67 days after a severe stroke, but the study record showed no sign of a cardiovascular problem.

Another patient died after being hospitalized for a serious heart problem, but the death was listed as arising from an unknown cause and not as being heart-related.

Correctly interpreted, he concluded, the study actually supports critics’ contentions that Avandia may cause heart attacks and strokes.

“One does not have to be a mathematician or to perform calculations,” he wrote, to come to the conclusion that a combined look at all the trials of Avandia would demonstrate that it causes, heart attacks.

Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline, said, “The Record study was conducted according to good clinical practices, and the data are reliable.”

Marciniak’s review is part of a reassessment of Avandia’s safety by FDA medical officers to educate the panel meeting Tuesday and Wednesday.
Debate about Avandia’s safety and how to handle reports of its dangers has split the food and drug agency and led to fierce recriminations, staff departures and questions from Congress.

It was the FDA’s delay in issuing stronger warnings about Avandia that led Congress in 2007 to give the agency greater powers over drug makers.

Within the FDA, some officials insist that the evidence is mixed and others say it is strong enough to merit the drug’s withdrawal. An advisory meeting in 2007 concluded that Avandia did increase heart attack risks but that it should stay on the market.

Although endocrinologists have advised against its use, Avandia remains popular with nearly 2 million prescriptions last year. If the drug were to be withdrawn, GlaxoSmithKline — already facing lawsuits claiming Avandia caused injuries — would likely see its liability soar.

(Except of course, in Texas, where pain and suffering is capped at $250,000)

Consumers should stop using Zicam Cold Remedy nasal gel and related products because they can permanently damage the sense of smell federal health regulators said Tuesday.

The over-the-counter products contain zinc, an ingredient scientists say may damage nerves in the nose needed for smell. The other products affected by the Food and Drug Administration’s announcement are adult and kid-size Zicam Cold Remedy Nasal Swabs.

The FDA says about 130 consumers have reported a loss of smell after using Matrixx Initiatives’ Zicam products since 1999. Shares of the Scottsdale, Ariz.-based company plunged to a 52-week low after the FDA announcement, losing more than half their value.

“Loss of the sense of smell is potentially life-threatening and may be permanent,” said Dr. Charles Lee of FDA’s compliance division. “People without the sense of smell may not be able to detect dangerous life situations, such as gas leaks or something burning in the house.”
Matrixx defended the safety of its products but said it may remove them from the market.

The FDA said Zicam Cold Remedy was never formally approved because it is part of a small group of remedies that is not required to undergo federal review before launching. Known as homeopathic products, the formulations often contain herbs, minerals and flowers.
A warning letter issued to Matrixx on Tuesday asked the company to stop marketing its zinc-based products, but the agency did not issue a formal recall. Instead, regulators said Matrixx would have to submit safety and effectiveness data on the drug.

“The next step, if they wish to continue marketing Zicam intranasal zinc products, is for them to come in and seek FDA approval,” said Deborah Autor, director of FDA’s drug compliance division.

Matrixx has settled hundreds of lawsuits connected with Zicam in recent years, but says on its Web site: “No plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell.”

Government scientists say they are unaware of any data supporting Zicam’s labeling, which claims the drug reduces cold symptoms, including “sore throat, stuffy nose, sneezing, coughing and congestion.”

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For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it can’t be sued by women who claim that they were injured by the product, even though its old label inaccurately described the amount of estrogen it released!

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.  The Bush administration has argued strongly in favor of the doctrine, which holds that the FDA is the only agency with enough expertise to regulate drug makers and that courts should not second-guess its decisions. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.

More than 3,000 women and their families have sued Johnson & Johnson, asserting that users of the Ortho Evra patch suffered heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the food and drug agency received reports of at least 50 deaths associated with the drug.

Documents and e-mail messages from Johnson & Johnson, made public as part of the lawsuits against the company, show that even before the drug agency approved the product in 2001, the company’s own researchers found that the patch delivered far more estrogen each day than low-dose pills. When it reported the results publicly, the company reduced the numbers by 40 percent. This was done, it later said, to adjust for the different ways the body metabolizes hormones from pills and patches. This adjustment was never part of the ‘study protocol, a plan filed with the FDA.

High doses of estrogen are known to raise the risk of blood clots that can cause heart attacks and strokes.

The FDA did not warn the public of the potential risks until November 2005, six years after the company’s own study showed the high estrogen releases. At that point, the product’s label was Changed, and prescriptions fell 80 percent, to 187,000 by February from 900,000 in March 2004.

According to Janet Abaray, a plaintiff’s lawyer from Cincinnati, Johnson & Johnson took advantage of an agency overwhelmed by its many, responsibilities. “Johnson & Johnson knew that FDA does not have the funding or the manpower to police drug companies,” Abaray said.

A series of independent assessments have concluded that the agency is poorly organized, scientifically deficient and short of money. In February, its commissioner, Andrew von Eschenbach, acknowledged the agency faces a crisis and might hot be “adequate to regulate the food and drugs of the 21st century.”
The FDA does not test experimental medicines but relies on drug makers to report the results of their own tests honestly.

Last month, at a trial over the schizophrenia drug Zyprexa, Dr. John Gueriguian, a former FDA scientist, testified that the agency did not always ask for strong warnings when it thought a drug was risky. Companies often oppose warnings, and the agency knows it must compromise on its requests or face years of delay, Gueriguian said.

For years, agency leaders acknowledged that lawsuits could aid the agency’s oversight of safety. In the past decade, several lawsuits have shown that companies played down the risks of their medicines and failed to disclose clinical trials to the public.