Safety and Risks: January 2007 Archives

FDA widens safety reviews on New Drugs

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FDABy GARDINER HARRIS, NY Times

The Food and Drug Administration announced changes yesterday that were intended to ensure that marketed drugs are as safe as advertised, including the first effort to do a comprehensive assessment of the safety of drugs 18 months after introduction.

The agency also announced the creation of an advisory panel to improve the way it announces safety worries and a collaboration with the Veterans Health Administration to track how real patients fare after taking drugs.

Wyeth loses Prempro trial, to pay $1.5 million

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lawsuitNEW YORK (Reuters) - A state jury in Philadelphia on Monday found Wyeth's hormone replacement therapy (HRT) Prempro was responsible for an Arkansas woman's breast cancer and ordered the U.S. drugmaker to pay $1.5 million in compensatory damages, a court official said.

The jury found that Wyeth was negligent in failing to provide adequate warnings about the breast cancer risk associated with Prempro.

The jury is expected to return, possibly as soon as Tuesday, to decide punitive damages after also finding that Wyeth's conduct was "malicious, wanton, willful or oppressive or showed reckless indifference to the interest of others" in its failure to provide proper warnings about its HRT drugs, taken by millions of women to treat symptoms of menopause.

seroxatLONDON, Jan. 29, 2007-Documents revealed tonight on BBC One's Panorama programme suggest that Britain's largest drugs company deliberately misled doctors about the safety and effectiveness of its antidepressant and promoted it as a treatment for children.

Panorama (8.30pm, Monday 29 January 2007, BBC One) has had exclusive access to thousands of internal memos which GlaxoSmithKline (GSK) released to lawyers involved in United States legal action against the company.

The documents show that as far back as the late Nineties there was an acknowledgement within GSK that tests had failed to prove that Seroxat was a safe or beneficial treatment for depressed children.

Court orders review of Vioxx class suit

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vioxxTRENTON, N.J. (AP) - A New Jersey appellate court panel on Tuesday opened the door to a potential class action lawsuit against Merck & Co. on behalf of people who took its now-withdrawn painkiller Vioxx and want the company to pay for tests to detect possible heart ailments.

The ruling by the Appellate Division of the Superior Court of New Jersey came as jury selection began in Atlantic City for the next product liability trial over Merck's one-time blockbuster arthritis pill.

That trial, before Superior Court Judge Carol Higbee, is slated to begin with opening arguments Monday. It includes two plaintiffs: the son of a man who died of a heart attack after taking Vioxx and a retrial for a man who survived a heart attack, lost his first trial against Merck and was granted a new trial because of new evidence.

FDA User-Fee Deal Fails to Fix Drug Safety Crisis

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FDAWASHINGTON, Jan. 11 /PRNewswire-USNewswire/ -- A proposed user-fee deal negotiated in private between the pharmaceutical industry and the FDA earmarks some funds for drug safety, but Consumers Union says the Administration must significantly fund comprehensive safety efforts, and Congress must pass new laws, to adequately protect the public from dangerous drugs.

"At a time when countless drugs have safety problems, it isn't enough to just rely on money paid by the pharmaceutical industry to fund needed drug safety reforms," said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports.

"To address the wholly inadequate drug safety system, consumers need a commitment from the Administration to completely fund drug safety, and new laws that will ensure we don't have any more Vioxx-type disasters," Vaughan said.

FDAWASHINGTON--(BUSINESS WIRE)--The recommended improvements to the Prescription Drug User Fee Act (PDUFA) announced today by the Food and Drug Administration (FDA) will allow continued enhancement of FDA’s post-market safety capacity and help ensure careful, timely and transparent review of new drugs and biologics, said the Biotechnology Industry Organization (BIO). The FDA’s recommendations come as a result of extensive discussion and input from industry, as well as patient organizations, consumer groups and other stakeholders. Since its inception in 1992, PDUFA has helped to enable FDA to approve more than 1,100 new medicines and reduced review times for innovative drugs and biologics, providing patients and doctors with earlier access to breakthrough treatments. The current PDUFA agreement is set to expire on September 30, 2007.

“The PDUFA recommendations announced today are a win-win,” said BIO president and CEO Jim Greenwood. “If enacted, they will help enhance and improve drug safety while providing resources to continue to enable efficient and comprehensive review of new drugs. These proposals underscore our industry’s commitment to ensuring the government has the needed resources to complete safety reviews for new drugs and biologics in a timely manner.”

Cough and cold remedies may be lethal to infants

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cough remediesAfter investigating the deaths of three infants between 1 and 6 months of age linked to cough and cold medication use, officials with the U.S. Centers for Disease Control and Prevention are emphasizing that these drugs should be used only after talking with a physician.

Between 2004 and 2005, approximately 1,500 children younger than 2 years old were treated in U.S. emergency departments for adverse events associated with cough and cold medications, Dr. A. Srinivasan and colleagues at the CDC note in the January 12th issue of the Morbidity and Mortality Weekly Report

For each of the three dead infants, a medical examiner or coroner determined that the cough and cold medications were the underlying causes of death.

FDAWASHINGTON--(BUSINESS WIRE)--The recommended improvements to the Prescription Drug User Fee Act (PDUFA) announced today by the Food and Drug Administration (FDA) will allow continued enhancement of FDA’s post-market safety capacity and help ensure careful, timely and transparent review of new drugs and biologics, said the Biotechnology Industry Organization (BIO). The FDA’s recommendations come as a result of extensive discussion and input from industry, as well as patient organizations, consumer groups and other stakeholders. Since its inception in 1992, PDUFA has helped to enable FDA to approve more than 1,100 new medicines and reduced review times for innovative drugs and biologics, providing patients and doctors with earlier access to breakthrough treatments. The current PDUFA agreement is set to expire on September 30, 2007.

“The PDUFA recommendations announced today are a win-win,” said BIO president and CEO Jim Greenwood. “If enacted, they will help enhance and improve drug safety while providing resources to continue to enable efficient and comprehensive review of new drugs. These proposals underscore our industry’s commitment to ensuring the government has the needed resources to complete safety reviews for new drugs and biologics in a timely manner.”

Lilly's Legal Battle Over Zyprexa Documents Continues

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Eli Lilly has paid out 700 million dollars to over 8,000 litigants who accused the company of injuring them with the antipsychotic drug Zyprexa.

Author: Evelyn Pringle

On January 3, 2007, a hearing was held before Judge Jack Weinstein in a US District Court in New York, on a motion by Eli Lilly to extend an injunction to conceal company documents that show Lilly hid the lethal side effects of Zyprexa for a decade and engaged in an illegal off-label marketing scheme to promote the drug for unapproved uses.

Zyprexa is only FDA approved to treat adults with conditions related to schizophrenia and bipolar disorder, and yet its Eli Lilly's number one best selling drug with sales of over $4 billion last year.

Safety data a trade secret?

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NHTSABefore you buy a car, would you want to know how many complaints people had made to the manufacturer about defects, or how many warranty claims had been paid, or how many dealers had reported problems with the vehicle?

Federal law says you have a right to such info. But the Bush administration and the auto industry are quietly trying to change that.

In 2000, Congress passed the Transportation, Recall Enhancement, Accountability and Documentation Act to address regulators' failure to spot defects in Firestone tires that were linked to numerous deaths.

FDAby Dani Veracity

Last year, Public Citizen, a national non-profit public interest organization, exposed that while conflicts of interest at the FDA's drug advisory committees are common and often have serious dollars at stake, advisory committee members and voting consultants rarely step down because of them. If a new conflict-of-interest amendment by Congressman Maurice Hinchey, D-NY, goes through, this will soon change for the better.

The foundation of the American drug approval process is theoretically objective science; however, the very nature of the process often allows subjectivity to come into play. In order for a new pharmaceutical to be approved by the FDA, the Center for Drug Evaluation and Research (CDER) looks at the pre-approval clinical trials paid for by the drug's maker and determines whether the drug is safe and effective. This is done at a rate of 25 to 30 new pharmaceutical drugs per year, according to Public Citizen.

Eli Lilly agrees to settle 18,000 Zyprexa claims

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zyprexaINDIANAPOLIS -- Eli Lilly and Co. said Thursday that it will settle about 18,000 additional lawsuits alleging that the drug maker did not adequately warn patients that its anti-psychotic medication Zyprexa carries a heightened risk of diabetes.

Lilly did not disclose the amount of the settlement but said in a statement that it would take a fourth-quarter settlement charge that is not expected to exceed $500 million.

The announcement follows a settlement in June 2005 under which the Indianapolis-based company agreed to pay about $700 million to resolve more than 8,000 similar lawsuits involving Zyprexa, its top-selling drug.

An Unimpressive Century of Food Safety

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FDAThis week marks the 100th Anniversary of the implementation of the Pure Food and Drug Act, a landmark piece of legislation calling for federal inspection of food products and paving the way for the creation of the Food and Drug Administration. However, as a January 2 New York Times editorial points out, advances in food safety are far from adequate considering how much time has elapsed.

Though nearly a century had passed, 2006 may have been the nadir of the federal food safety era. A spinach contamination outbreak in the fall killed three, and mysterious Taco Bell food poisonings only aggravated national concern. The Times editorial points out that anti-government conservatism has been a contributing factor in the declining safety:

Parkinson's drugs linked to heart damage

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dostinexPeople taking two drugs to treat symptoms of Parkinson's disease may be at risk of heart valve damage, a potentially life-threatening side-effect, two studies on European patients suggest.

The drugs are pergolide, sold as Permax, and cabergoline, sold as Dostinex. The medications are not the main treatment for the disease, which affects about six million people worldwide.

In Thursday's New England Journal of Medicine, Italian researchers said about one-quarter of 155 patients taking pergolide or cabergoline had moderate to severe heart valve problems compared with a control group.

Food Agency Urged to Limit Cancer-Causing Substance

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acrylamide in fried foodJan. 2 (Bloomberg) -- A consumer group said U.S. food regulators have backed away from plans to limit a cancer-causing byproduct that forms during the baking or frying of foods, including products from PepsiCo Inc., the largest U.S. maker of salty snacks.

The group, the Center for Science in the Public Interest, based in Washington, sent a letter to U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach on Dec. 1, urging him to follow through on agency promises to limit acrylamide. Swedish scientists discovered in 2002 that the substance develops in carbohydrate-rich foods, such as potatoes and breakfast cereals.

After initially reporting variations in acrylamide levels in branded products within the same food categories, the FDA has stopped publishing the information, and food makers refuse to provide it to the public, said Michael F. Jacobson, executive director of the Center. He said the FDA isn't reporting test results or setting limits.

What policymakers can learn from a $21 billion failure

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drug safetyby Paul Howard, The Examiner

WASHINGTON - William Osler, one of the founding faculty members at Johns Hopkins Medical School, once remarked: “If it were not for the great variability among individuals, medicine might as well be a science and not an art.” A century later, medicine is, despite its technical prowess, in many ways still an art — albeit an expensive one.

Pfizer learned that lesson the hard way in early December, when they halted development of their much anticipated “good cholesterol” boosting drug, torcetrapib. A late-stage clinical trial revealed excess deaths and cardiovascular problems in patients taking the drug together with Lipitor, compared to Lipitor alone.

In the 15,000-patient trial, there were 82 deaths for the torcetrapib combo vs. 51 for Lipitor. The failure cost Pfizer $800 million in research costs, $20 billion in market capitalization and 15 years of research.