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The Baycol / Lipobay - Scandal

Profiting from the fear of heart attacks

(Stern-Magazine / August 16, 2001) - The wonder pill that can make you ill. The furore over Bayer's cholesterol-lowering drug Lipobay shows just how pharmaceutical firms and doctors profit from drugs that are inadequately monitored, often at the cost of patient safety.

As long ago as last autumn, the critically-minded pharmaceutical experts of the Berlin-based medical information service arznei-telegramm (Medicines Telegram) suspected that there was trouble ahead. In their view, there had to be something wrong with the cholesterol-lowering agent (HMG-CoA reductase inhibitor) cerivastatin. Month after month, reports piled up about dangerous side effects and particularly about the progressive muscle disorder rhabdomyolysis. Following further bad news from around the world, the arznei-telegramm informed German doctors: "The Australian drugs authority is warning of the dangers of rhabdomyolysis in connection with the HMG-CoA reductase inhibitor cerivastatin (Lipobay, Zenas). A similar picture is emerging from reports to the German Federal Institute for Medicinal Products and Medical Devices, expressing further suspicions. Most concerns (46 in all) have been reported in connection with the newest HMG-CoA reductase inhibitor, introduced in September 1997. Cerivastatin offers no therapeutic advantage. We see no indication for this possibly risky HMG-CoA reductase inhibitor." That was in March this year.

On 2nd July, the arznei-telegramm sent out an urgent notice to the effect that cerivastatin puts patients at risk. The evidence against the drug had mounted up to such an extent that the specialists were asking how it was possible for this medication, actually intended to protect against arteriosclerosis, cardiac infarction and angina pectoris, to remain on the market.

Last week, Bayer AG, the discoverer and distributor of the drug, withdrew cerivastatin. With this product, sold in Germany as Lipobay and in other countries as Baycol, the international drugs group was sacrificing its third largest revenue earner in the pharmaceutical sector, a drug with an annual turnover in the billions of Deutschmarks and a mainstay of its global strategy. Only in Japan will the product continue to be sold for the time being.

Forty deaths connected to the drug have so far been recorded around the world, five of them in Germany. The most serious and potentially deadly side effect of Bayer's cerivastatin is rhabdomyolysis. With symptoms including pain and swelling, the victim's muscle fibres disintegrate. Breakdown products from the dying tissues find their way into the blood stream and become trapped in the kidneys. By blocking the tubules in the detoxifying organs, they eventually cause acute renal failure. "If patients survive this," explained Professor Bernd Mühlbauer, a clinical pharmacologist in Bremen, "they often have to spend the rest of their lives undergoing dialysis."

This risk is accepted by millions of people, so that they can benefit from the statins, the group of pharmaceutical products that include Bayer's drug. These substances regulate the blood fat levels and, depending on their structure and dosage, they can lower cholesterol concentrations in the vessels by up to 50 per cent. Until recently, the statins were hailed as a triumphant success in the fight against cardiac disease. The idea was that you could simply take a pill and put an end to all the difficulty and frustration of trying to bring blood cholesterol levels down to a medically decreed normal level. It was not, however, quite so easy after all.

Cholesterol blocks the vessels like lime-scale in a water pipe, and the end result is a myocardial infarction. This simplistic logic is so widespread that it can hardly be dislodged from people's minds any longer. The real relationships are, however, significantly more complex. Too high a cholesterol level is - alongside obesity, smoking and infections - only one of many risk factors. Half of all infarction sufferers meet their fate despite moderate blood fat levels. But the simple logic is seductive: instead of avoiding eggs and losing weight, better to swallow a few pills, bringing blood cholesterol levels back to normal and, hey presto, you can breathe easily again.

Supported by extensive studies of cardiac patients, from the mid-1990s, the statin producers brought the full weight of their medical congress and advertising machinery to bear in order to secure themselves a new multi-billion dollar market. It was in 1987 that the American Food and Drug Administration licensed the first statin, lovastatin from Merck. That roused competitor firms, who then began feverishly to produce similar substances that would achieve the same result but would differ sufficiently from lovastatin to warrant their own patent and a separate marketing concept. Today in Germany, six different statins are licensed, Bayer's Lipobay/Baycol being the latest to reach the market in 1997. The latecomer claimed to be as effective as the other drugs, but with much lower dosages.

The statins enjoyed success beyond comparison and, at the end of the 1990s, they displaced the previous best-seller drug in the USA, the "good mood" pill Prozac. Since then the statins have been the most prescribed group of pharmaceuticals in American practice.

As the statins were enjoying their success, doubts began to grow about the traditional cholesterol theory. The undisputed positive effects of the drugs on patients already suffering cardiac disease came about much faster than could be explained by reducing fat levels alone. It became clear that a significant part of the statins' positive effect was due to little-researched side-effects of the preparations. Although this may sound strange to a lay person, it is nothing unusual to pharmacologists. The term "side-effects" does not necessarily mean something unwanted in their parlance. Indeed, for years, most side-effects of statins have proved to be welcome ones. For instance, they stabilise the formation of chalky and fatty deposits in the coronary vessels and prevent them tearing away from the arterial wall, which is what blocks the blood flow and triggers an infarction. The constantly emerging, new and unhoped-for capabilities of the drugs also made clear that millions of people were being treated with drugs about which the specialists still had only sketchy knowledge.

In the flood of praise for statins, sceptical voices and warning signs were drowned out. In a report only 16 lines long, the Bild newspaper informed readers on 18th July of: "Four deaths from anti-cholesterol drugs" in Spain. And a recent report in the British New Scientist about the frequent occurrence of impotence with statin treatment also fell mainly on deaf ears.

In view of sensational marketing successes and constant double-figure growth rates, the industry meanwhile decided to expand its target group as planned. Was it not true that everyone in the industrialised world had reason to fear myocardial infarction and angina pectoris? Should not everyone do something about their health, especially if it involves no effort, costs only a few pence per day and comes in a handy pill form?

Plans for this marketing drive were laid by the pharmaceutical industry in conjunction with pharmacists, doctors and generously sponsored health associations. A poster advertising campaign invited people to go for a blood test at their local pharmacy. And on the internet, even the young surfer - hardly at risk of heart disease - is told that there is never any reason to be complacent and that there is no such thing as a perfectly healthy person.

Even a completely fit visitor to the website www.cholesterin.de is treated to this grotesque presumption. As soon as the subject has answered all the questions such as "Do you smoke daily?", "Are you more than 10 kg overweight?", "Do you suffer from high blood pressure?", "Do you have relatives (parents or siblings) who have suffered myocardial infarction or stroke?" with "No", the risk calculator advises him or her: "Although your risk of a myocardial infarction is probably below average, you should seek an opportunity to speak to your doctor about cardiovascular disease and your cholesterol level." The calculation upon which this is based is surely that as soon as the person is faced with a person dressed in a white coat, he or she will start to feel really concerned. The sponsors of the site are the pharmaceutical companies Gödecke, Parke-Davis, Pfizer and Mack. Here in Germany they sell the statin Sortis and have reason to hope they can now persuade abandoned Lipobay users to take up their products. When, last Thursday, the Ärzte-Zeitung announced the demise of the Bayer product, on the opposite page of the journal there was an advertisement for Sortis with the caption: "Trust in the force".

According to the wish of the manufacturers, doctors play a decisive role in the almost blanket coverage of the population with cholesterol inhibitors. After all, between statin and patient there stands the statutory obligation to prescribe it. The doctor must therefore be motivated and encouraged to become a "good prescriber" as the industry jargon has it, and put as many patients on statins as possible. And the patient who first takes a cholesterol-lowering drug will usually continue taking it for the rest of his or her life.

The recruiting of good prescribers by the constantly growing marketing army of the pharmaceutical industry requires creative ideas, plenty of money and a very flexible understanding, on both sides, of what constitutes corruption. In 1999 the arznei-telegramm reported on a case in point: "With a payment of DM 120, the company MSD motivates doctors to take part in its "Quality Trial" Protect II and thus induces further prescriptions of the HMG-CoA reductase inhibitor Sortis. In this way it buys prescriptions for about DM 2500 per patient per year. One physician complained that repeat prescriptions were demanded of him for a patient even when the cholesterol level had not normalised on the treatment." Bayer proved to be particularly inventive. As a reward for putting 25 patients onto Lipobay, the company treated Bavarian doctors to a trip on the Orient Express.

The belief that every practising doctor is always aware of the latest research and would know how to protect his patients proved naïve in the case of cerivastatin. The most serious problems with the product occurred when it was combined with another type of cholesterol-lowering drug, namely gemfibrozil, a drug belonging to an older group of active substances called fibrates.

Gemfibrozil, if taken at the same time, causes the blood concentration of cerivastatin to be elevated four-fold, which greatly increases the risk of muscle damage. Physicians well versed in pharmacology had been aware of this interaction for a long time. Nevertheless, the drugs were blithely combined in order to achieve the most impressive blood fat reductions - on the assumption that a lot would help a lot. The typical statin patient - somewhat older, with an already damaged heart and all kinds of other illnesses - is particularly at risk from interactions between different drugs. He or she takes an above- average number of them. The possible consequences of the mixture are never entirely predictable, even for experienced physicians. For that reason, the initiative taken last year by the two leading statin manufacturers seems all the more strange. In order to milk the mass market yet further, they asked the US authorities to exempt lower-dosed versions of their drugs from the prescription requirement, so that everyone fearing for their heart could freely buy them beyond the reach of medical supervision. The proposal was refused.

Despite the current Lipobay debacle, the remaining statin manufacturers hardly have grounds to worry. A few months ago, the American guidelines on infarction prophylaxis were radically revised, with the result that the number of US citizens enjoying the benefits of cholesterol-lowering medications rose from 13 million to 36 million. Like every medical megatrend, this is also spilling over into Europe.

And if experience does not deceive, the case of cerivastatin will be no more than a footnote in the history of pharmaceuticals - as a strategic manoeuvre by a company wanting to grab a slice of the big cake. The failure of this manoeuvre was paid for by Bayer's shareholders on Wednesday last week, when the share price fell by 17 per cent - and by a yet unknown number of patients with their lives.

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