State Attorneys Still Investigating in the Lipobay Case - German Newspaper - January 15, 2002

State Attorneys Still Investigating in the Lipobay Case
By: Stephanie Holzinger
German Newspaper
January 15, 2002

Translated from German. Science Die Welt Page 31.

Patients in Germany switched to other cholesterol reducers - 52 deaths from taking replacement preparations

New York - The Bayer AG stock exchange listing in the U.S. that had been planned for the end of January could be in danger once again. The first launch in September of last year failed as a result of the scandal surrounding the medication Lipobay. The company suffered huge losses as a result of the market withdrawal. The cholesterol reducer was Bayer's third-ranked medication in terms of sales revenue. Its expected sales revenue potential was 2.5 billion euro per year. The concern is now threatened with losses once again as a result of the compensatory damage complaints that have now been filed.

However, the patients are worried more about their health than the economic consequences for Bayer. Ulrike Kassner, physician in the fat metabolism clinic at Berliner Virchow-Klinikum, reports on the initial patient reactions after the withdrawal: "Many patients first stopped taking the medication on their own and then made an appointment with us. In the interim, we have switched all patients to different preparations that, like Lipobay, belong to the group of statins."

But these alternatives are not lacking in danger either; they work according to the same principle as Lipobay-and therefore have similar side effects. Just a few days after the withdrawal of Lipobay, the American consumer organization Public Citizen presented a study, in which it also warned against the other preparations. It claimed that a muscular breakdown called rhabdomyolysis had also occurred in over 385 cases involving the taking of statins. Rhabdomyolysis can occur as a side effect of medications and can trigger kidney failure, which in the worst case scenario results in death.

Thus, according to Public Citizen, 52 of the 385 affected persons died; exactly the same number of deaths as when Lipopay was taken. 52 deaths were reported worldwide; there have been seven deaths in Germany. However, the Federal Institute of Drugs and Medical Products believes that a link is only possible in three cases. The risk of side effects with Lipobay rose, above all, in combination with Gemfibrozil, another cholesterol reducer, and in an excessively high dose. However, the deaths involving the alternative preparations studied by Public Citizen occurred under monotherapy in 88 percent of the cases.

As a result of these observations, the consumer watchdogs demanded that the U.S. drug supervisory agency FDA provide the insert sheet of the other statins with a so-called black-box warning that pointed out the specific risk of muscular breakdown. Lipobay had such a notice concerning the side effects. Nevertheless, it was prescribed to six million patients worldwide, including in combination with Gemfibrozil.

Kassner believes that something good has ultimately come of the scandal surrounding Lipobay: "This affair has increased the level of alertness. We physicians respond with increased sensitivity to any symptoms of a rhabdomyolysis, as does the patient himself." But in principle, she stated, drug side effects are nothing unusual. "Every medication has an effect and a side effect that must be specifically monitored." As far back as 1998, a study by the University of Toronto revealed that fatal drug side effects are the fourth leading cause of death in the U.S. For example, an estimated 500 deaths are said to have occurred as a result of Viagra; nevertheless, the medication remains on the market.

Why did Bayer nevertheless voluntarily take one of its strongest-selling medications off the market? "We determined that our warning notices, particularly in the U.S., were of no avail," said Bayer press spokesman Michael Diehl by way of explanation of the decision. In addition, he stated, a Bayer study involving three million patients revealed that Lipobay has a relatively high rhabdomyolysis risk when used with Gemfibrozil.

The Federal Institute of Drugs and Medical Products accused Bayer of not having informed it of these results in a timely manner. But Diehl states that "we completed this report on June 15, 2001, and sent it to the competent British agency, the MCA, immediately." The Institute has in the interim withdrawn its accusation and the intended fine imposition proceeding.

But an investigative proceeding is still pending with the Cologne Office of the State Attorney involving the accusation of violation of the Drug Act. "If this accusation proves to be correct, there will certainly be a further proceeding to examine the question of whether Bayer AG was guilty of negligent physical injury," Günther Feld of the Office of the State Attorney's press office stated.

But the question of compensatory damages will probably be of more importance to the persons affected. In Germany, Munich attorney Michael Witti is working particularly hard to bring complaints of this type. The class action lawsuits of German victims are being heard in the U.S. as a result of the different nature of compensatory damage law there. In the Lipobay case, Witti is collaborating with the American law firm of Kenneth B. Moll and attempting to assert claims in the billions against Bayer AG. The Leverkusen concern sees this as no cause for alarm: "We are not worried, because we believe the complaints are without merit," according to Diehl.

But in Kassner's view there is no doubt that there has been a fundamental change in therapy using cholesterol reducers. "Multiple studies have shown that medicinal treatment substantially reduces mortality and therefore improves life expectancy." But, according to her, the treatment must be individually tailored according to the disease pattern.

Naturally, she said, there is no immediate reaching for the pill, even though many patients would like to see that. "First, we arrange for diet counseling," Kassner explained. She pointed out that a simple change in diet will help many patients to substantially reduce their cholesterol levels. "Only if that does not help do we talk to the patient about a medicinal therapy and clarify the advantages and disadvantages, as well as the risks."

In her opinion, the oft-used catch phrase patient compliance, which stands for patient cooperation, cannot mean "physicians says-patient does." "The patient should not view himself as a passive victim who places his health condition in our hands," Kassner stated, "but instead as someone who takes advantage of the right to be informed and makes his own decisions."