Recently in drug companies Category

NEJM amicus brief supports failure-to-warn claims against Wyeth Laboratories.

A group of current and former editors of The New England Journal of Medicine, along with several well-known NEJM contributors, recently filed an amicus brief in U.S. Supreme Court, charging pharmaceutical companies with deliberately withholding relevant adverse-reaction data when their profits are at stake. The brief was filed in conjunction with the Wyeth v. Levine case, in which drug giant Wyeth Laboratories is appealing a Vermont Supreme Court decision awarding $6.8 million to Diana Levine, who had to have her arm amputated after improper administration of the Wyeth anti-nausea drug Phenargan.

Levine's lawsuit charges that the drug contained inadequate warnings and instructions for use. Wyeth, in turn, is claiming that FDA authority to approve drug labeling preempts state failure-to-warn litigation regarding prescription medication. In the summary of its argument supporting Levine, the amicus brief stated:

"The argument of Petitioner [Wyeth] and its amici ('Petitioner/Amici') that federal preemption of state law failure-to-warn claims involving prescription drugs will actually make the world a safer place is riddled with factual fallacies. First, contrary to Petitioner's/Amici's necessary premise, the FDA is in no position to ensure the safety of prescription drugs. Not only is the FDA seriously hampered in its ability to determine the risks of drugs before they are approved for sale, but it has proven inadequate to the task of addressing hazards that only become apparent after a drug has been widely marketed to an unsuspecting public. Post-approval dangers posed by drugs placed into the market are unfortunately quite common. However, the FDA's ability to either anticipate these risks or react expeditiously once they have been revealed has been limited by serious information-gathering constraints in both pre- and post-approval settings."

Part of the difficulty the FDA has in addressing drug risks, according to the brief, stems from the fact that it is forced to rely on the manufacturers themselves for outcome data upon which to base its decision to either approve or disapprove a drug. The brief went on to use the examples of three different drugs - Pondimin/Redux, Vioxx and Trasylol - in which the manufacturers allegedly withheld key information from the FDA and strongly argued against stricter label warnings, all the while continuing to market these drugs to an unsuspecting public. In all cases, the companies allegedly manufactured data, ghostwrote articles for medical journals and/or withheld negative findings from the FDA.

The worst of these offenders in terms of estimated patient deaths was the anticoagulant Trasylol, marketed by Bayer. The drug was found to cause kidney failure. According to the amicus brief: "Between 1999 and 2005, Bayer generated over $935 million in revenue from sales of Trasylol with over $353 million in 2005. Bayer forecast that Trasylol would some day generate upwards of $600 million annually." Although exact numbers may never be released, an estimated 242,000 deaths were likely attributable to Trasylol between its release in 1993 and its eventual withdrawal from the market in May 2008.

In light of these examples and others, the brief argues strongly in favor of the FDA and the legal system working together to enhance consumer protection:

"Product liability lawsuits and the FDA have peacefully coexisted for seventy years for one simple reason: they have complementary, rather than conflicting, goals. The tort system complements the federal regulatory structure by providing a mechanism for compensating victims of hazardous drugs. Product liability litigation provides the FDA with key information unearthed in litigation that the agency can use to better protect the public from unsafe and inadequately labeled drugs. At the same time, the tort system and the FDA are similarly constrained.

"Whereas the FDA, as a regulatory body, weighs the risks against the benefits of a drug, in 'failure-to-warn' litigation most state courts require a similar balancing between the cost of care owed to a patient versus the prospective harm."

The brief went on to conclude:

"[G]iven that pharmaceutical companies have been known to equate increased warnings with a loss of sales, they would have an incentive to delay warnings as long as possible. As has been shown, certain pharmaceutical companies have already proven themselves unwilling to prioritize safety over profits, even when faced with the threat of civil liability. It is chilling to imagine how such companies might conduct themselves if the threat of tort liability for dangerous drugs were eliminated entirely by virtue of federal preemption."

The full text of the amicus brief, along with all other briefs filed in the lawsuit, is available online at www.abanet.org/publiced/preview/briefs/nov08.shtml#wyeth.

This article was published in Acupuncture Today, The Acupuncture and Oriental Medicine News Source

"Psoriasis is a systemic disease and should be treated as such, a fact that Chinese medicine has identified for hundreds of years. A recent article published in the British Journal of Dermatology stated that people with psoriasis have an increased risk of heart disease. The authors stated that traditionally western dermatologists mainly focused on psoriasis in the skin and joint level, but failed to view any correlation to other organ systems.

Because psoriasis is an immunoinflammatory disease, affecting the body as whole, it makes sense that the same inflammation causing the skin manifestations could also aggravate other diseases known to be induced by inflammation, particularly cardiovascular disease. See research here.

Chinese medicine's view of psoriasis as a systemic inflammatory disease is seen in the main traditional patterns attributed to it, mainly fire toxins and heat in the blood with stasis. It has always held that psoriasis is a disease of the blood, hence any part of the body influenced by the blood can be affected, particularly the heart.

It is interesting to see that many of the herbs used to treat psoriasis in Chinese medicine also have cardiac protective properties. Dan Shen, Salvia miltiorrhiza, is one of them. I use the herb a lot in my prescriptions to treat psoriasis, as it's main functions are to cool and invigorate the bloods flow. Dan Shen has been used both traditionally and in modern times to protect and repair heart tissue. Many studies have been done on this herb and I recommend you look at my research section to view one of them.

The more western research that comes out showing that the body is an integrated whole, that problems in one area (like the skin) influence other body areas, the more impressed I am with the observations of the ancient Chinese. By treating the roots of a disease pathoglogy, then not only is the disease itself healed, but so is a multitude of other associated problems. This is wholistic medicine."

Trevor Erikson, March 25, 2009 ;The Chinese Medical Dermatology Website

Mr. Erikson's Skin Disease Photo Gallery shows Before and After pictures of skin diseases treated with TCM.

Trevor Erikson's article is apt because of this April 8, 2009 article in the New York Times "Genentech announced on Wednesday a phased voluntary withdrawal of the psoriasis drug Raptiva from the United States because of a link to a brain infection.

Raptiva has been associated with an increased risk of progressive multifocal leukoencephalopathy, a rare and usually fatal disease of the central nervous system."