E-drug: How a statin might destroy a drug company
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Interesting editorial in this week's Lancet. Clearly profits are more
important than patient safety in mulitnational companies. Copied as fair
use. KM]
Lancet 2003; 361: 793 (8 March) www.thelancet.com
Editorial
How a statin might destroy a drug company
Bayer, the German drugs giant, is backed against the ropes because of
compensation claims for cerivastatin. In the face of massive potential
losses, the company's share price fell last week to �8�53 from a high in the
past year of �25�07. Bayer believes the market is over-reacting. The company
placed advertisements in several German national newspapers at the end of
February. "Fakten statt Stimmungsmache" headlined the advert, which
translates as "Facts rather than spin". The advert continues: "Because we
can again comment, we would like to immediately bring facts into the
forefront. We very much hope that we--especially in the interests of our
shareholders--can thus counteract the current upheaval in the share market."
Bayer's woes arose because cerivastatin, launched as the sixth statin in the
marketplace at the end of 1997, became linked with serious myopathy, severe
enough to lead to rhabdomyolysis and death, especially when given with a
fibrate such as gemfibrozil to lower triglycerides. Cerivastatin was
launched at lower doses, and Bayer subsequently sought and gained approval
for doses of 0�4 and 0�8 mg. The company voluntarily withdrew the drug in
the USA on Aug 8, 2001. By then, the drug had been linked to over 100 deaths
from rhabdomyolysis. In a letter in February, 2002, that reported a study of
prescription monitoring and adverse-reaction reporting (N Engl J Med 2002;
346: 539-40), scientists at the US Food and Drug Administration (FDA) said
that the rate of fatal rhabdomyolysis with cerivastatin was 16-80 times
higher than for any other statin (31 deaths with cerivastatin vs 42 with all
five other statins). When cases of concomitant use of cerivastatin with
gemfibrozil or lovastatin were excluded, the rate was still 10-50 times
higher. With cerivastatin alone, six investigated deaths occurred after use
of 0�4 mg and 12 with 0�8 mg.
There are about 7800 claims for compensation in the USA and about 500 in
Germany. About 450 of the US cases have been settled by Bayer without coming
to trial and without the company admitting liability. The first case came to
trial in Corpus Christi, Texas, last week, and Bayer was immediately in deep
water in court. The company had sent a letter to over 2000 local residents,
reminding them that it employs nearly 2000 people in Texas and contributes
about US$185 million to the state's economy in payroll, taxes, and support
of local groups. In its letter, Bayer lumped all statins together when
discussing the potential for serious side-effects in a "small segment" of
the population, but failed to mention the FDA comparative data for
rhabdomyolysis and statins, alone or with gemfibrozil--which, of course,
would show cerivastatin outlying the other drugs in the class. The judge
said the sending of the letter was "outlandish", and has deferred a decision
on how to deal with Bayer until the case on trial is over. One of Bayer's
lawyers apologised in court and said the letter was a mistake; it was meant
to go only to the town's chamber of commerce.
Bayer intends to fight the compensation claims vigorously. It said the
action in Texas and a class action that is forming in Minnesota quoted
internal company documents out of context, and it will put in the context
later in the hearings. Bayer insists that it acted properly and in a timely
manner when informing regulatory authorities about myopathy with
cerivastatin. Bayer also seeks to blame prescribers for ignoring labelling
changes--ie, giving gemfibrozil with cerivastatin when this became
contraindicated and not starting patients on a low dose.
If Bayer is found guilty of negligence in the marketing and timing of its
eventual withdrawal of cerivastatin, the company may founder. But a strong
general signal will then be sent to the drug industry, which is especially
pertinent for the statins. These drugs are highly effective in the
prevention of heart attacks--indeed, some experts advocate much wider use of
statins. But the message following the cerivastatin disaster is of the law
of unintended consequences. In the enthusiasm for wider use of a class of
drugs, all must remember that rarer side-effects are unlikely to be seen in
clinical trials before a drug is approved. Post-marketing surveillance can
teach salutary lessons about the need for caution when new drugs are
promoted to physicians.
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