'Fine print' raised doubts: Finding applies only to preventive use
Tuesday, September 16, 2003
CanWest News Service
Drugs taken daily by millions of Canadians to lower their cholesterol at a cost of more than $1.3-billion a year may be doing as much harm as good for many users, according to a group of University of British Columbia drug specialists.
The drugs, called statins, "have not been shown to provide an overall health benefit" when prescribed to people who have not already had a stroke or heart attack and do not have cardiovascular disease, say researchers at the UBC-based Therapeutics Initiative, which assesses the effectiveness of drugs.
The group has sent a bulletin to 12,000 B.C. doctors and pharmacists outlining concern about statins. Last year, Canadian doctors wrote 14 million prescriptions for the drugs. Often, the pills are prescribed to patients who do not have clogged arteries but are considered at risk for a heart attack or stroke because they have risk factors, such as high cholesterol, hypertension or obesity.
Large international studies have found using statins for such "primary prevention" does lead to a 1% to 2% decline in heart attacks and strokes over three to five years. But that benefit appears to be negated by serious adverse effects, said Dr. Jim Wright, head of the UBC group.
He said the studies mention "in the fine print" that the total number of serious adverse events occurred at the same rate in people taking statins and those swallowing dummy pills. "This indicates that the magnitude of the harm caused by taking statins for primary prevention is about the same as the benefit," he said.
Putting it another way, he says the number of heart attacks and strokes was lower for people taking statins, but the incidence of other serious health problems increased.
The studies, which involved close to 40,000 people in North America, Europe and Britain, do not elaborate on what the serious adverse events were. But Dr. Wright says they would include all life-threatening events -- such as cancer, mental problems and car accidents -- that land people in hospital.
"They are the kind of thing nobody wants to have happen," says Dr. Wright, who also works with Cochrane Collaborative, an international group that assesses the value of medical inventions and drugs.
Dr. Wright says researchers are required to collect data on serious adverse events as part of drug trials, but do not have to release details. His team at UBC has asked for such information from drug researchers and government regulators in the past and has been told it is proprietary.
"We are challenging them to start releasing the data," Dr. Wright says. Serious adverse event data should be posted on the Web whenever drug trials are published in medical journals, he says.
Statins are racking up multi-billion-dollar sales worldwide. Use of the pills has more than doubled in Canada in the past five years.
The drugs are frequently described as lifesavers with few side effects. But it is known that statins can cause muscle aches and weakness. In rare cases they can lead to muscle breakdown, known as rhabdomyolysis, which can cause kidney failure and death. One potent statin, called Baycol, was pulled from the market in 2001 after 31 rhabdomyolysis deaths in the United States.
There have been suggestions that long-term use of statins might increase cancer rates and trigger mental and cognitive problems.
Other research has indicated statins may help prevent Alzheimer's disease and treat multiple sclerosis.
"Drugs are all double-edged swords," Dr. Wright says. "They all have some downside and we need to look at adverse effects more carefully than we do."
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