Selling Sickness

How the World's Biggest Pharmaceutical Companies are Turning us All into Patients

Sunday, November 20, 2005

Pharmaceuticals and the push to pop: Ottawa Citizen

Shelley Page

A new book argues that drug companies are redefining what it means to be 'healthy,' turning us all into patients and pilltakers

The big guns of cardiology met this week at the American Heart Association and discussed the future of statins, cholesterol- lowering drugs that are the bestselling pills on the planet. Studies released there suggest that while statins have worked well in fighting bad cholesterol, known as LDL, beyond a certain point the benefits may be slim. Experts suggested drug companies should focus on finding drugs to push up good cholesterol, HDL.

If LDL encourages dangerous plaque to build up and clog artery walls, HDL clears away the plaque. What if a new class of drugs could increase the so-called "good" cholesterol?

The question, posed to a new generation of researchers, should be greeted with some skepticism. Reducing heart attacks and heart disease is crucial, of course. But while statins were becoming the most popular drugs in history, pharmaceutical firms were changing our very definitions of health. Almost at once, people formerly considered healthy were popping one pill or another.

In fact, the authors of a new book titled Selling Sickness argue that drug companies are turning all of us into patients. So while the cardiologists were meeting in Dallas, Alan Cassels and Roy Moynihan were voicing their concerns about the ways drug companies are widening the net of illness, until formerly healthy people have been redefined as sick.

Mr. Cassels, a drug policy researcher at the University of Victoria, and Mr. Moynihan, an Australian health-care journalist, focus on the push to make people pop statins, which generate revenues of more than $25 billion a year for their manufacturers. Canadians gobbled up $1.6 billion worth of statins last year alone.

In 2003, for example, AstraZeneca was poised to launch Crestor, its newest cholesterol-lowering drug. It was a controversial announcement because the drug was said to have double the side- effects of other such drugs. Still, fortune seemed to smile on the big pharmaceutical company.

Dr. Bryan Brewer, a giant in the cholesterol field, was raving about the drug. The senior official with the publicly funded National Institutes of Health told a meeting of the American Health Association that the drug was safe and effective.

His comments were later published in a special supplement of the American Journal of Cardiology, a journal released just as Crestor hit the U.S. market.

The authors question Dr. Brewer's ties to AstraZeneca. Turns out he was one of AstraZeneca's paid speakers. Not only was his seminar and journal supplement financed by AstraZeneca, "so too was Dr. Brewer, though his links were not disclosed in his article in the journal supplement."

Congress hearings would eventually reveal Dr. Brewer received $200,000 U.S. a year from "outside private interests including drug companies, while holding down his position as branch chief at the government's NIH," write the authors.

Before 1987, there wasn't a single statin on the market. Then Merck launched Mevacor, which was seen as a valuable option for people with heart disease. Since then, more and more statins have been developed, including Pfizer's Lipitor, the world's top-selling prescription drug -- ever.

The authors show how the definition of high cholesterol has been regularly broadened to relabel more and more healthy people as sick, thus creating a broader group of patients who could be targeted with drug therapy.

It's certainly possible that, in fact, more people require treatment than was originally thought. But the authors don't think so, and neither do a growing chorus of independent health-care research groups.

According to cholesterol guidelines from the 1990s, 13 million Americans might have required statin treatment. In 2001, a new panel rewrote the guidelines and the number increased to 36 million.

Then in 2004, yet another panel broadened the guidelines to say 40 million Americans would benefit from taking statins. While these new guidelines were being redrawn, the U.S. -- where, unlike Canada, direct-to-consumer advertising is permitted -- was bombarded with advertising that without statins healthy Americans could die of heart attacks.

Many of those who expanded the guidelines were cosy with the drug companies that would benefit. In 2001, five of the 14 authors, including the chair of the panel, had financial ties to statin manufacturers. In 2004, the "conflicts of interest were even worse."

"Eight of the nine experts who wrote the latest cholesterol guidelines also serve as paid speakers, consultants or researchers to the world's major drug companies -- Pfizer, Merck, Bristol-Myers Squibb, Novartis, Bayer, Abbott, AstraZeneca and GlaxoSmithKline. In most cases, the individual authors had multiple ties to at least four of these companies.

"One 'expert' had taken money from 10 of them," write Mr. Cassels and Mr. Moynihan. The links only became public when they were uncovered by journalists.

In Canada, the guidelines have expanded to include more and more people formerly considered "healthy." Earlier this year, the Canadian Medical Association Journal
reported that new Canadian guidelines have dramatically changed the threshold for "high" cholesterol so that an additional 500,000 Canadians should be taking statin medication -- at a cost of more than $250 million.

Almost all of the increase, according to the CMAJ, consisted of low-risk patients. The number of low-risk people for whom statins are recommended -- if lifestyle modification fails to achieve target lipid levels -- increased tenfold to 595,000 from 61,000. Yet, they reported that the relative benefit of statin therapy for many people in the low-risk group is "incredibly small."

Individuals who have heart disease may reduce the threat of heart attack by five or six per cent over 10 years by taking a statin every day. But there is no good evidence to show statins reduce the chance of premature death in low-risk groups.

Evidence also suggests high-risk individuals are being underprescribed while drugs are wildly overprescribed to low-risk individuals.

Mr. Cassels worries about the long-term consequences, especially because some of these drugs were linked recently to potentially fatal muscle-weakening disease. This summer, Health Canada warned that some of the millions of Canadians taking statins risk developing muscle-related problems that could lead to kidney failure and death.

In an interview, Mr. Cassels said doctors must stop overprescribing drugs to healthy people. He blames the cosiness between doctors and drug reps, who litter medical offices with free samples and misleading information on the benefits of drug therapy.

Mr. Cassels says some health advocacy groups are fighting to force the health-care system to again redefine the boundaries, this time reducing them. One U.S. group is campaigning for an independent review of official cholesterol guidelines.

Mr. Cassels acknowledges that many might shrug, asking what harm an extra pill a day can do. Look at the big picture, he urges. The $250 million it costs to put low-risk patients on statins could go to reducing waiting lists or buying more useful services from doctors.

Shelley Page's Second Opinion column on health-related issues runs weekly.

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