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- October 11, 2004
- Vol. 62
- No. 15
A Bitter Pill?
Dr. Marcia Angell Prescribes Major Reform for Drug Companies
You've said that consumers have every right to be angry with drug companies. Why?
Americans now spend $200 billion a year on prescription drugs. We're paying very high prices, and more and more people can't afford them.
You argue that costs are soaring because drug companies are misleading consumers. How?
Their trade association, PhRMA, promotes the idea that drug companies can barely cover their research costs. They want us to believe that if s a risky industry, and that they're working day and night to produce innovative drugs. The truth is that the major companies, sometimes called "big pharma," spend relatively little on research; In 2002 the median for the top 10 American companies was about 14 percent of sales. The reality is that it's an enormously profitable, low-risk industry with a vast marketing machine.
Isn't their success based on developing new drugs?
When a big company does bring an innovative drug to market, it's almost always based on publicly funded research. Their major output is not innovative drugs but minor variations of top-selling drugs. They do it because if s easy and lucrative and they can get away with it. These are called "me too" drugs.
Give us an example.
Lipitor, which lowers cholesterol, is the world's top-selling drug. It is a variation of the first of such drugs, Mevacor. There are five almost identical statins competing with Lipitor, and there's little reason to believe that one is better than another in comparable doses. Like other "me too" drugs, Lipitor, Zocor and the others are much more expensive than the original, which became available as generic lovastatin when Mevacor's patent expired.
PhRMA argues that variations are worthwhile because a given patient may be able to tolerate one and not the other.
Until they test that proposition, it's an unsubstantiated assertion. Drug companies rarely test their drugs against one another at comparable doses, nor do they test them in patients who have not done well on another one.
What are other ways big pharma manipulates consumers?
By turning ordinary concerns into a medical condition: "erectile dysfunction," for example. They're promoting the "disease," trying to convince men that anything less than 110 percent performance requires treatment.
What about truly innovative drugs?
Only 17 of the 78 drugs that were approved to enter the market in '02 contained new chemical compounds, and the FDA classified only seven of those as likely improvements over existing drugs. Not one of the seven came from a major American company.
Have industry tactics changed?
Most drug trials are sponsored by pharmaceutical companies. It used to be that they'd give a grant to a researcher at an academic medical center, then cross their fingers. But that changed in the 1980s. The companies insisted on designing the studies themselves, which means they could increase the likelihood of favorable results. They would keep the data, analyze it and even decide if the results would be reported.
Where does the FDA fit in?
The FDA requires that a new drug be tested, but not against an old drug. It only has to be compared to a placebo, which means that if it's better than nothing, it gets on the market.
You claim that big pharma has major clout in Washington. How?
The industry has more than 600 lobbyists on Capitol Hill. They demand and get all sorts of special favors, such as the provision in the recent Medicare prescription drug benefit that Medicare would not bargain for lower prices.
How do the drug companies influence doctors?
A huge part of the companies' budgets goes to what they call education, which is really marketing. They support most continuing medical education and medical conferences. Salespeople go to doctors' offices bearing not only free samples but gifts, meals, junkets.
What can consumers do now?
Say to your doctor when you're getting a prescription, "Is there a generic for this? Is there a cheaper drug?" And if the doctor says, "This one is better," ask what that's based on. It may help them rethink what they're doing.
Is it smart to save by purchasing drugs by mail from Canada?
Yes. The FDA has campaigned to cast doubt on Canadian drugs, and it's nonsense. There's no reason to believe that if you are dealing with a registered pharmacy in Canada that counterfeiting, for example, is any more likely than with drugs obtained here.
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