The withdrawal of a drug from the market would hardly seem grounds for Christmas cheer, but it may be simply an indication that the winds of change are finally upon us.
On September 30 of this year, the pharmaceutical giant Merck summarily yanked its best-selling COX-2 arthritis drug Vioxx off the market overnight. The data monitoring board of the US Food and Drug Administration had called a halt to a long-term study of the drug after evidence emerged that Vioxx doubled the risk of heart attacks. The FDA then acted swiftly to issue a Public Health Advisory on the drug, and Merck did the decent thing by voluntarily withdrawing its product.
But the demise of Vioxx is only the beginning of the doldrums for America's second largest group of pharmaceuticals, which had been among the most financially robust of companies, with one of the highest credit ratings in all of US industry. After having to junk one of the biggest moneyspinners of all time, Merck's share price has plummeted to a nine-year low.
In early November, hundreds of plaintiff lawyers met in Las Vegas, rubbing their hands together as they began discussing strategies for litigation. Merck estimates that the lawsuits could cost the company as much as $18 billion, according to a Merrill Lynch report. The report reckons that some 50,000 Americans may have suffered heart attacks or strokes while on the drug, and will join in the class-action lawsuit. Each individual award or settlement could cost Merck between $100,000 and $300,000 - not to mention the patients alleging other injuries that could cost the company an additional $1 billion to $2 billion. A Merck spokesperson has said that reserve funds have not yet been tallied, but suffice it to say that more than 20 million Americans and millions of others around the world have been prescribed Vioxx since its release in 1999.
The lawsuits are likely to be fueled by an analysis, just published in The Lancet, of all clinical trials of Vioxx that had been completed by 2001. In the august journal's view, both the FDA and Merck should have seen the writing on the wall years ago and had to good sense to pull the drug off the market then.
Another nail in the coffin is the FDA's own website report, which concluded that more than 27,000 heart attacks and 7000 deaths could be attributed to the drug.
Merck's liability could even outstretch that of other companies such as Bayer, which confirmed that it has paid more than $1 billion for nearly 3000 lawsuits, and has more than 7500 suits pending. Meanwhile, Wyeth, which produced the discredited diet drug fen-phen, has put aside more than $16.6 billion to cover liabilities for plaintiffs who have decided to opt out of a settlement programme of a $3.75 billion trust fund.
The news about the COX-2s and other arthritis drugs (see Drug Alert, pages 6 and 7) arrived just minutes after the FDA took a harder line about another family of drugs - the SSRI (selective serotonin reuptake inhibitor) antidepressants, which now have a black-box warning about suicide risk. While no one likes to dance on a commercial grave - and this won't be a grave for a company with pockets as deep as Merck's - such a series of public hangings rattles the public's blind faith in drugs, particularly magic bullets, and reinforces the message that the means to good health lies elsewhere - in all the alternatives that form the stuff of this newsletter.
May all of you, seniors and juniors alike, be healthy and wise this holiday season by finding your own path to those alternatives through these pages.