Thursday, April 10, 2008

Dangerous Pharmaceutical Companies

Perhaps we should be grateful to the pharmaceutical industry for developing and marketing the medications that prolong our lives, alleviate our symptoms, and ease our pain. We could not persist as a modern society without them. And yet, one gets the impression that a cruel and cut-throat culture has seized control of the drug companies. There are a number of indications that there is an ethical black hole at the center of the pharmaceutical industry. Among the indications are tremendously overpriced drugs, constant price increases, enormous profits, and a ruthless, wealthy, powerful lobby. That lobby was able to impose its will on the Republicans in Congress in 2003 and force them to enact a Medicare Part D Drug Program that enriches the pharmaceutical industry while it short-changes senior citizens, the government, and the taxpayers.

For the past few years, television watchers have been bombarded with advertisements for Vytorin and Zetia, drugs used to lower cholesterol. The ads for Vytorin are very clever. They show some tasty food with a picture of Aunt Matilda and say that cholesterol comes from two sources, the food you eat and the genes you inherit from your relatives. Zetia advertises that it is an excellent alternative to statins. Thanks to the media blitz, Vytorin and Zetia have been among the most widely prescribed medicines in the United States, with sales of $5 billion in 2007.

Nevertheless, tests have now shown that the two drugs do not reduce plaque in the arteries as advertised. Although “Outcome Trials,” which are expensive, multi-year clinical trials with 10,000 or more patients, have shown that statins like Zocor and Lipitor reduce LDL cholesterol and lower the risk of heart attacks, there have been no such trials for Vytorin and Zetia.

The companies that manufacture Vytorin and Zetia did conduct a so-called “Enhance” trial of the two drugs, but failed to reveal the results until two years after it was completed. Senator Charles Grassley of Iowa has released information showing that the lead outside investigator on the trial accused Merck and Schering-Plough, the manufacturers of the drugs, of deliberately delaying the release of the trial results “to hide something.” When they were finally released, the trial’s results showed that Vytorin and Zetia did not reduce plaque in arteries. The results led a panel of cardiologists to recommend that the drugs be used only as a last resort.

Long after they had ample information about the ineffectiveness of Vytorin and Zetia, the manufacturers continued to blanket the airwaves with commercials extolling the benefits of these two virtually useless concoctions. What does that say about the consciences of the executives who run Merck and Schering-Plough? We are not talking about headache remedies here. We are talking about people’s lives. Millions of people took these remedies in lieu of life-saving statins. Who knows how many people died because they did not get the proper prescriptions?

Merck and Schering-Plough are not the only offenders of this kind. There are many useless or dangerous drugs foisted on the public by unscrupulous pharmaceutical companies. But Merck deserves special mention as a prime offender. It not only promoted and sold ineffective medications, it also continued to market a downright dangerous drug, Vioxx, long after its ill effects were apparent.

Vioxx is a non-steroidal anti-inflammatory drug that was FDA approved to treat rheumatoid and osteoarthritis, migraines, and other acute and chronic pain conditions. The danger of Vioxx had been a concern since it was first approved for use in the United States in 1999. Early tests showed that Vioxx users had higher numbers of cardiovascular side effects than users of another drug, naproxen.

In 2000, a study to test the effects of Vioxx on colon polyps had to be cut short after eighteen months because patients who had taken Vioxx were two times more likely to suffer heart attacks or strokes than patients taking a placebo or Vioxx alternative. The New England Journal of Medicine said in an editorial that Merck & Co., the maker of Vioxx, withheld data and information that would affect conclusions drawn in the study. Merck conducted further tests, but despite further evidence of the danger of Vioxx, did not pull the drug off the market until 2004. I wonder how many people died because of Merck’s callous indifference.

I don’t know how many Americans have been killed by terrorists in Iraq, but it may be that the number is smaller than the number of those killed by taking ineffective or unsafe medications in America.

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