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Two Reports of Merck Misconduct

(#1 of 2)    19Apr2011    Nuvaring Birth Control

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At Merck, an Undercover Video and 40 Deaths
Plague Nuvaring Birth Control Brand


By Jim Edwards    MoneyWatch    19Apr2011    cbsnews.com
[the two topics addressed in this article are distinguished by rendering one of them in blue]

About 40 women have died using Merck (MRK)'s Nuvaring contraceptive device, according to a Swiss report, as the company faces 730 lawsuits in U.S. courts.  Separately, Merck staff were videotaped leading a group of European ob/gyns in a pop-music singalong promoting Nuvaring at a boozy event that was supposed to be educational, according to an Estonian business daily.  The two events suggest Merck's Nuvaring troubles may yet become a PR headache for the company.

The U.S. cases allege that Nuvaring has a propensity to cause potentially lethal blood clots because it delivers a constant, ongoing dose of hormones instead of the rising-and-falling doses experienced by women who take a birth control pill.  Although it was not a secret that Merck was litigating over Nuvaring, few people noticed a German-language report in Switzerland last year that claimed there were 40 deaths "in round figures" contained in the FDA database of adverse events associated with the drug.  The database contains unconfirmed reports that vary wildly in quality, so the true number of deaths will likely be lower.

Merck has grown sales of Nuvaring into a respectable business.  Although it is a niche product — not all women want to use a suppository — it had $559 million in sales last year.  [...]

In the Estonia video, which appears to have been shot with a cellphone, doctors are shown being served alcohol before sitting through a Merck presentation on Nuvaring that featured dancers waving outsize Nuvaring devices.  The report says no risk information was provided to doctors:

In the video, a speaker is heard saying that "Nuvaring is suitable for absolutely everyone—" and then merry gynecologists take part in a sing-along to popular tunes rewritten to feature NuvaRing.

Sponsored medical education seminars are supposed to contain serious research content.  When the reporter finally identified herself to a Merck exec and asked for an interview, the exec told her to go to hell.  [...]



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Two Reports of Merck Misconduct

(#2 of 2)    27Apr2012    Half a Million Americans Died

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When half a million Americans died
and nobody noticed


Alexander Cockburn     27Apr2012     theweek.co.uk

Was the US drug Vioxx responsible for far more deaths than has been acknowledged so far?

ARE American lives cheaper than those of the Chinese?  It's a question raised by Ron Unz, publisher of The American Conservative, who has produced a compelling comparison between the way the Chinese dealt with one of their drug scandals — melamine in baby formula — and how the US handled the Vioxx aspirin-substitute disaster.

The Chinese scandal surfaced in 2008, shortly before the Beijing Olympics.  Crooked dairymen diluted their milk products, then added a plastic chemical compound called melamine to raise the apparent protein content back to normal levels.  Nearly 300,000 babies across China suffered urinary problems, with many hundreds requiring lengthy hospitalisation for kidney stones.  Six died.

Long prison sentences were handed down and a couple of the guiltiest culprits were tried and executed for their role.  Throughout these events, American media coverage was extensive, with appropriate sneering about the Chinese leadership's indifference to human life.

Four years earlier, in September 2004, Merck, one of America's largest pharmaceutical companies, issued a sudden recall of Vioxx, its anti-pain medication widely used to treat arthritis-related ailments.

The recall came just days after Merck discovered that a top medical journal was about to publish a study by an FDA (Food and Drug Administration) investigator indicating that the drug in question greatly increased the risk of fatal heart attacks and strokes and had probably been responsible for at least 55,000 American deaths during the five years it had been on the market.

It soon turned out Merck had known of potential lethal side effects even before launching Vioxx in 1999, but had brushed all such disturbing tests under the rug.

With a TV ad budget averaging a hundred million dollars per year, Vioxx swiftly became one of Merck's bestsellers, generating over $2 billion in yearly revenue.  Twenty-five million Americans were eventually prescribed Vioxx as an aspirin-substitute thought to produce fewer complications.  [...]

"We find the largest rise in American mortality rates occurred in 1999, the year Vioxx was introduced, while the largest drop occurred in 2004, the year it was withdrawn," says Unz.  "Vioxx was almost entirely marketed to the elderly, and these substantial changes in the national death-rate were completely concentrated within the 65-plus population.

"The FDA studies had proven that use of Vioxx led to deaths from cardiovascular diseases such as heart attacks and strokes, and these were exactly the factors driving the changes in national mortality rates."  [...]

Unz [...] concludes: "Perhaps 500,000 or more premature American deaths may have resulted from Vioxx [...].  [...]

"The inescapable conclusion is that in today's world and in the opinion of our own media, American lives are quite cheap, unlike those in China.

"Besides," says Unz laughing, "it shows the stupidity of our political leaders that they didn't seize upon this great opportunity.  They should have just renamed Vioxx the 'Save Social Security Drug,' and distributed it free in very large doses to everyone, starting on their 65th birthday.  Maybe they should have even made it mandatory, three times per day.  At sufficiently large levels of national consumption, Vioxx could have almost singlehandedly eliminated all our serious budget deficit problems.  'Vioxx — The Miracle Anti-Deficit Drug'."