Saturday, March 10, 2007

FDA Warning of Heart and Cancer Risks for Anemia Drugs

Article in the Wall Street Journal -- FDA Warning Is a Blow to Amgen: 'Black Box' Label On Anemia Drugs Also Hits J&J, by Marilyn Chase and Anna Wilde Matthews.  Here's an excerpt:

The Food and Drug Administration issued a sweeping safety warning about heart and cancer risks that arise from overuse of a family of anemia treatments that is the biotech industry's biggest drug class with $7.3 billion in U.S. sales in 2006.

The agency's safety advisory -- a so-called "black box warning" on the labels of all drugs in the class, called Erythropoiesis Stimulating Agents -- came sooner than analysts expected, two months ahead of a scheduled FDA advisory meeting to discuss risks on May 10. The move comes as the FDA is under pressure from Congress to show that it is focusing on drug safety, in the wake of a series of incidents including the market withdrawal of the painkiller Vioxx.

Hardest hit by the new warning is Amgen Inc., Thousand Oaks, Calif. The biotech giant alone accounted for $5.3 billion in U.S. sales from its best-selling products Aranesp and Epogen in 2006. Johnson & Johnson's Procrit fetched another $2 billion in U.S. sales. Roche Group AG, Basel, Switzerland, plans to launch its rival product, Cera, this spring despite a bitter patent battle with Amgen that has divided the onetime partners.

FDA officials said the black box was sparked by recent studies that have pointed to risks tied to the drugs, particularly when doctors used them for very aggressive treatments. Karen Weiss, deputy director of the agency's office of oncology drug products, said the "bulk of the data that has raised concerns" came when patients were given higher-than-recommended doses, whether they were suffering from anemia tied to kidney problems or cancer treatment. The evidence is that "this type of strategy is not beneficial and in fact has some evidence of harm," she said.

***

Plaintiffs attorneys are already looking into possible suits. "When you have a corrective action by this FDA, it's not just smoke," says plaintiffs' attorney Mike Papantonio of Levin Papantonio Thomas Mitchell Echsner & Proctor, in Pensacola, Fla.

The New York Times also has an article, F.D.A. Warning Is Issued on Anemia Drugs’ Overuse, by Andrew Pollack.

BGS

March 10, 2007 in FDA | Permalink | Comments (0) | TrackBack (0)

Friday, March 9, 2007

Study Shows No Benefits from Lung Cancer CT Scans

Article in the Washington Post -- Lung Cancer Study Says CT Scans Yield No Benefits.  The lack of any benefits from lung cancer CT scans would suggest that they would be of no use in any proposed medical monitoring claims.  Here's an excerpt from the article:

A new study suggests that screening smokers and former smokers for lung cancer with CT scans does not save lives or prevent the disease to advance, and may lead to unneeded and harmful treatment.

Some experts have hoped that the scans will prevent lung cancer deaths by getting people into treatment earlier. But there has been no convincing evidence of that. Without that evidence, the American Cancer Society does not recommend the test, which costs $300 to $400. Most insurance firms do not cover it.

BGS

March 9, 2007 in Tobacco | Permalink | Comments (0) | TrackBack (0)

Wednesday, March 7, 2007

Possible Lung Cancer Molecular Screening Test

Article in the Chicago Tribune -- Lung cancer screening test called exciting: Boston University team shows it is possible to detect precancerous changes in normal tissue, by Judy Peres.  Such an early detection test could have implications for medical-monitoring claims, if beneficial treatment could be offered based on the test.  Here's an excerpt from the article:

Scientists may be close to being able to predict who will develop lung cancer, a development that could prevent tens of thousands of deaths a year in the U.S.

Using a molecular test called a microarray, a research team from Boston University has come up with an 80-gene "signature" that can identify lung cancer in smokers at a very early stage. More important, the team showed that it is possible to detect precancerous changes in normal tissue.

"It's like a molecular Pap smear," said Dr. Avrum Spira, who led the investigation.

The Pap test, which can detect abnormal cells in cervical tissue, is credited with greatly reducing deaths from cervical cancer. But instead of examining whole cells, as the Pap does, microarrays examine every gene encoded in the cell's DNA.

BGS

March 7, 2007 in Tobacco | Permalink | Comments (0) | TrackBack (0)

Tuesday, March 6, 2007

New Jersey Judge Declines to Overturn Phase I Jury Vioxx Verdict

Article in the Wall Street Journal -- New Jersey Judge Denies Plaintiff 'Do Over' Motion in Vioxx Trial, by the Associated Press.  Here's an excerpt:

The judge presiding over a Vioxx personal injury trial in Atlantic City on Monday rejected a motion to give one of the two plaintiffs a second shot at winning damages from drug maker Merck & Co.

The jury on Friday ruled that Merck was not negligent in the case of Brian Hermans of Waupaca, Wis., who died at age 44 after a September 2002 heart attack. That meant his family could not collect damages.

However, the jury did find that Merck violated New Jersey's consumer fraud law, so Mr. Hermans' family could recoup three times what he paid for Vioxx prescriptions, plus about $2 million in costs and fees his lawyer requested.

The lawyer, Mark Lanier, late Friday asked Superior Court Judge Carol Higbee to overturn the jury's ruling that Merck wasn't negligent in the Hermans' case. Mr. Lanier argued Mr. Hermans had started taking Vioxx before April 2002, when Merck put a stronger warning about the drug's cardiac risks in the detailed package insert, and he hadn't seen his doctor since then. Judge Higbee rejected the motion Monday.

BGS

March 6, 2007 in Vioxx | Permalink | Comments (0) | TrackBack (0)

Congressional Panel Examines Off-Label Use of Drugs and Medical Devices

Article in the Wall Street Journal -- Congressional Panel to Study Off-Label Use of Stents, Drugs, by Keith J. Winstein.  Here's an excerpt:

A congressional committee is looking into the "off label" use of drugs and heart stents, examining the widespread practice in which doctors prescribe medical products to patients outside the boundaries approved by the Food and Drug Administration.

Boston Scientific Corp. and Johnson & Johnson's Cordis unit, the only makers of drug-coated stents sold in the U.S., were asked to submit marketing materials and clinical data to the House Committee on Oversight and Government Reform on Wednesday. About 60% of drug-coated stents, which prop open clogged arteries, are used off-label. For example, manufacturers haven't rigorously tested their stents in patients who have had heart attacks, but stents are commonly given to such patients. Doctors are allowed to prescribe stents to off-label patients, but manufacturers can't encourage off-label use.

The committee's chairman, California Democrat Henry Waxman, also asked for marketing materials from three drug companies that have come under scrutiny over whether they promoted their products for unapproved uses: Eli Lilly & Co., whose antipsychotic drug Zyprexa had $4.36 billion in sales last year and was the company's best seller; AstraZeneca PLC, which makes another depression drug, Seroquel; and Cephalon Inc., whose marketing of painkillers has been under investigation by the Connecticut attorney general.

BGS

March 6, 2007 in FDA, Medical Devices - Misc., Pharmaceuticals - Misc., Zyprexa | Permalink | Comments (0) | TrackBack (0)