American Medical Association

ALSO NOTED: Acomplia linked to deaths in the U.K.; Does HDL really prevent heart disease?; and much more...

Wed, 04 Jun 2008 06:59:50 -0400

> While the FDA has been slammed by some drugmakers for its too-conservative approach to drug approval, it may have made the right move with Acomplia. But recent findings by the U.K.'s drug regulator show Sanofi's weight-loss drug has been linked to five deaths and 720 adverse reactions since the company launched it in Britain two years ago. Sanofi still hopes to re-submit the drug as a diabetes treatment. Report

> Scientists have linked high-density lipoproteins (HDL), also known as "good" cholesterol, to lower cardiovascular risk for quite some time, but the Journal of the American Medical Association released a study on June 3, 2008, saying that HDL might not be protective after all. HDL report

> Moody's Investors Service says U.S. drug manufacturers can expect to see their credit ratings drop over the next year, despite respectable cash flow and decent profitability. The report cites concerns about increasing levels of offshore cash by the companies. Report

> For the past 15 years Dr. Francis Collins has been a leader of the genetics revolution in the U.S. Last week he announced that he would be stepping down from the post. Report

> OncoMed's Michael Clarke, George Q. Daly at the Harvard Stem Cell Institute, Sir Martin Evans from Cardiff University and Rene Hen from BrainCells/Columbia University are among 12 stem cell luminaries highlighted by Forbes. Report

> A group of researchers theorized that genetic engineering used to block an immune response in cells outside the brain would accelerate the progress of Alzheimer's disease by spurring inflammation. Instead, they said, an animal study showed that the process eliminated as much as 90 percent of the amyloid plaque associated with the memory-wasting disease. Report

> The Buck Institute for Age Research was the only non-academic group to receive California stem cell grants for new research facilities this year. Report

And Finally... Move over mascara. Allergan announced today that it will be filing a new drug application for bimatoprost, a drug that it claims encourages eyelash growth. Report

ALSO NOTED: AMA joins DTC advertising fray; U.K. toughening up on pharma promos; and much more...

Fri, 09 May 2008 06:59:50 -0400

> We all expected Democrats to rake DTC ads over the coals during yesterday's hearing before the House Energy and Commerce Committee's oversight arm. What we didn't expect was for the American Medical Association to join the fray. DTC report

> U.S. lawmakers aren't the only ones toughening up on pharma promos. In the U.K., the industry itself is strengthening its code. Report

> Sanofi-Aventis and Bristol-Myers Squibb may have squashed copycat Plavix in the U.S., but competition is now popping up in Europe. Plavix report

> We've all heard the safety warnings about the Ortho-Evra birth control patch and its link to life-threatening blood clots. Public Citizen is now campaigning to have the patch taken off the market completely. Ortho-Evra report

> Researchers are touting the early results from a study of a new brain cancer vaccine that combines protein antigens extracted from a patient's tumor and matches them with white cells also drawn from the patient. Vaccine report

And Finally... The headlines may have died down in recent months, but bird flu experts say that the threat of a global pandemic has actually been growing. Report

ALSO NOTED: The WSJ profiles the FDA's lead regulator for cancer; Living Cell raises funds; new approach to gene therapy; and m

Wed, 19 Mar 2008 07:59:50 -0400

> The argument over the FDA's role in regulating cancer therapies often comes down to one man: Dr. Richard Pazdur, a veteran oncologist and chief of the agency's oncology office. Report

> A group of scientists have come together to highlight the revolution in personalized medicine that is being ushered in by dramatic new gains in genetic research. The Journal of the American Medical Association's March 19 issue is devoted to studies regarding genomics. Report

> Living Cell Technologies announced that it has received $6 million in relation to the placement of 24,150,408 ordinary shares, at a price of A$0.29 per share. Release

> A team of scientists led by British Nobel laureate Sir Aaron Klug has advanced a new approach to gene therapy. Report

> Nicox has struck a deal with Archimica on the commercial manufacturing of naproxcinod, an osteoarthritis drug it plans to seek approval for in mid-2009. Release

> What do you get when you mix 20 drug developers active in the diabetes field with a room full of geneticists? Hopefully, a new generation of therapies that pinpoint subsets of the disease. Report

> Scientists are heralding a "breakthrough" on blindness therapies. Report

> Raptor Pharmaceuticals says that its clinical development subsidiary, Bennu Pharmaceuticals, has acquired an exclusive worldwide license to intellectual property from the University of California, San Diego around the use of Cysteamine, and delayed release Cysteamine for the treatment of Non-alcoholic Steatohepatitis. Release

And Finally... The stem cell market has grown from zero to $87 million in less than three years, and analysts at the year's Stem Cell Summit were bullishly forecasting its growth to $8.5 billion over the next decade. Report

JAMA editor won't ban authors for nondisclosure

Tue, 08 Aug 2006 20:01:38 -0400

On the advice of attorneys, the editor of the Journal of the American Medical Association says she won't ban authors who fail to disclose their financial ties to the drug industry, as a ban might spur antitrust suits. A ban "would only encourage that author to send his or her articles to another journal; it cleans our house by messing others," says Catherine DeAngelis, who has been highlighting cases of authors who fail to adhere to JAMA's disclosure rules. Critics who had been calling for a ban immediately launched new assaults on JAMA, saying it was refusing to enforce even basic standards of conduct by authors.

- here's the article on JAMA from NewsTarget.com

Study authors failed to note ties to drug companies

Mon, 10 Jul 2006 20:01:37 -0400

In a study published last February in the Journal of the American Medical Association, a group of experts warned women that if they stopped taking their antidepression drugs they seriously raised their risk of relapse. But The Wall Street Journal notes that most of the authors have long-standing financial ties to drug companies that make antidepressants. None of those ties were revealed in the study. The authors and the drug companies say that the ties did not influence the study. But JAMA noted that it requires authors to reveal their financial ties and is publishing an explanation it received from the lead author. The drug industry routinely creates business ties with key thought leaders who are seen as tremendously influential in guiding patients' use of therapeutics. Those ties have come under a spotlight as the industry grapples with claims that they are buying influence to expand drug markets.

- here's The Wall Street Journal article for more (sub. req.)

Chantix outperforms Zyban in major study

Tue, 04 Jul 2006 20:01:37 -0400

New clinical studies in the Journal of the American Medical Association back up Pfizer's claims for the smoking cessation drug varenicline, which will hit the market as Chantix next month. The studies cover the results for 2,000 volunteers and found that 44 percent of the people taking Chantix continued to abstain from smoking after 12 weeks of therapy compared to 30 percent for subjects taking Zyban and 17 percent who took a placebo. Those results will give Chantix considerable help in its battle for market share, but researchers also note that there is still no drug that is effective for a majority of smokers. In a companion editorial, Robert Klesges of the University of Tennessee Health Science Center, also noted that many of the people who took part in the study dropped out after experiencing adverse events. Chantix works by generating dopamine, a reward chemical that reduces the craving for tobacco. The market for these products is huge, with four out of 10 smokers trying to kick the habit every year.

- here's the report on Chantix from the Chicago Tribune

PLUS: The New York Times examines the quest to find a vaccine that will block the addictive sensations of nicotine. Article

AMA wants moratorium on new drug ads

Wed, 14 Jun 2006 20:01:35 -0400

The American Medical Association is pushing for a moratorium on advertising new drugs, saying that there should first be a period in which doctors can learn about the new pharmaceuticals. Many in the drug industry have resisted a moratorium, insisting that advertising was a key method of educating the public.

- here's the report on the AMA from the Chicago Tribune

PLUS: The FDA, meanwhile, wants to stop the use of abbreviations in prescriptions, which the agency says can cause dangerous mistakes. Confusion over some abbreviations has been known to lead pharmacists to mix a new drug ten times the potency of the actual amount prescribed. Report

New study highlights risks of anti-TNF antibody class

Tue, 16 May 2006 20:01:37 -0400

A new study in the Journal of the American Medical Association concludes that people taking Abbott Laboratories' Humira or Johnson & Johnson's Remicade--both blockbuster meds--face triple the risk of cancer and double the risk of infections. While the chances of getting either cancer or an infection are still small, the study's authors conclude, these anti-TNF antibody drugs still pose threats that people should consider carefully. The drug makers responded by saying that the new study does not conclusively prove that the drugs are responsible for the added risks and that the research is flawed.

- read this article on the study from the Chicago Tribune

ALSO NOTED: NitroMed raising funds; PharmaGap releases data; NexMed garners $8M; and much more...

Tue, 24 Jan 2006 19:00:50 -0500

> NitroMed is raising more than $58 million through the sale of 6.1 million shares in order to launch its first product. Report

> PharmaGap has released the first animal efficacy data for its novel lead drug compound, PhGalpha1, a selective inhibitor of Protein Kinase C-alpha. Release

> NexMed of Robbinsville, NJ, has raised more than $8 million through the sale of securities. Release

> Akzo Nobel's chemicals subsidiary is closing a facility in The Netherlands and laying off 300 workers. Report

> Shares of Cozart surged after the medical diagnostics company announced a new deal with Philips Electronics to develop a new biosensor system. Report

And Finally… Writing in the Journal of the American Medical Association, a group of doctors maintains that the flow of freebies from drug companies and medical device makers undermines medical care in the United States. Article

Researchers link clotting drug to serious side effects

Tue, 17 Jan 2006 19:01:38 -0500

Novo Nordisk's clotting drug NovoSeven has been linked to a host of serious side effects, including deaths, strokes and heart attacks. The drug was approved by the FDA in 1999 to stop the bleeding of hemophiliacs. But physicians have also been using the drug--which costs $7,500 a dose--to treat cerebral hemorrhages. The side effects were largely concentrated among the cases involving off-label drug uses. The authors of the report at the FDA's Center for Biologics Evaluation and Research published their findings in the Journal of the American Medical Association. Novo Nordisk says that the drug has experienced few problems when prescribed for its approved use.

- read this Washington Post article