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Lawyers, Drugs and Money

Feb
1
2008

The essence of lying is in deception, not in words. – John Ruskin, Modern Painters

The news about the newest cholesterol lowering drugs and disclosure of the fact that there had been non-disclosure. It was reminiscent of the cigarette ads of many years ago. Plus ça change, plus c’est la même chose.

An ad for Philip Morris that appeared in the May 22, 1943 Saturday Evening Post was full of great news about Philip Morris cigarettes, even though by then their creator knew they were killing their friends and devotees. The ad’s headline in large letters cheerfully inquired: “Smoking Less or Smoking More*?” The asterisk referred one to a small note that proudly proclaimed: “Gov’t Figure show all-time peak in smoking”. That was followed by the statement that “You’re safer smoking PHILIP MORRIS!” It then went on to proudly state that those cigarettes were “Scientifically Proved less irritating for the nose and throat.”

Having gotten through the hype, the ad continues in a more sober vein stating that: “Reported by eminent doctors-in medical journals. Their own findings that when smokers changed to Philip Morris ‘every case of irritation of the nose or throat-due to smoking-either cleared up completely, or definitely improved!’” The additional good news imparted by the ad was that the subject of the tests that proved the beneficial effects of smoking were “actual men and women” as distinguished from “laboratory analysis” thus demonstrating conclusively that Philip Morris cigarettes were “far less irritating to your nose and throat.” The only caveat to the obviously unmitigated benefits of switching to Philip Morris was the equivalent to today’s warning that they might kill you. It stated: “NOTE we do not claim curative power for Philip Morris. But, man! What solid proof they’re better . . . . . safer. . . to smoke.” There’s no indication what text was omitted from the ellipses.

It was all brought to mind by Merck/Schering-Plough Pharmaceuticals full-page ads trumpeting the virtues of Zetia and Vytorin, the latter being a combination of Zetia and Zocor, a statin. The drug companies conducted a test called “Enhance” that ended almost two years ago. They forgot to disclose the results of the test until January 14, 2008. Among the results was the fact that Zetia failed to slow the accumulation of fatty plaque in the arteries and might have contributed to its formation. The tests also disclosed there might be adverse effects on the liver when Zetia was used in combination with statins, the drugs that lower cholesterol.

Dr. Harlan N. Krumholz, a Yale cardiologist faulted the drug companies’ failure to disclose the results of the study when they became available. Commenting to the New York Times he said: “People may have been on this drug without the ability to know that there was additional data that may have thrown into question its effectiveness. That’s extremely unfortunate, and that’s an understatement.” Dr. Steven E. Nissen, the chairman of cardiology at the Cleveland Clinic, described the results of the tests to the Times as “shocking” and went on to say that the test results were “as bad a result for the drug as anybody could have feared.”

It was not only a bad result for patients. It was also a bad result for stockholders in the two companies since the two drugs generated $5 billion in sales in 2007. Although the tests only raised the possibility of damage to the liver and threw into doubt whether or not those taking the drugs lowered their risk of heart attack, the tests actually did lower-the companies’ profits from sales of the drugs. Following disclosure of the report, the stock price dropped as it is expected that sales of the drugs will follow suit. Fortunately for stockholders, the two drug companies are not sitting quietly by. They have begun an advertising campaign to counter the bad results of the study believing, as all drug companies do, in the magical power of advertising.

In full-page ads in major newspapers around the country they describe the study one that has “generated a lot of confusion,” although apparently not in the minds of the doctors quoted above. The ad states that the “American College of Cardiology and the American Heart Association agree that lowering bad cholesterol is important,” conveniently overlooking the fact that while the drug lowered bad cholesterol it increased the growth of fatty plaque in the arteries when compared with patients taking Zocor alone. There is one difference between today’s ad and the cigarette ads of yore. Less than half of the Vitorin and Zetia ads extolled the virtues of the drugs. The remainder described in excruciating detail all the terrible things that might happen to those taking the drug as is the requirement in drug advertisements.

The ad won’t help those who have taken the medication. They can only hope it hasn’t harmed them. Whether it helps the stockholders to whom the companies appear to have greater loyalty, only time will tell.

Share  Posted by Christopher Brauchli at 9:33 AM | Permalink

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