Will we be as quick to swallow the next wonder drug?

[Guest guest]

Will we be as quick to swallow the next wonder drug?

 

By ANDRE PICARD

Thursday, October 7, 2004 - Page A21

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The withdrawal last week of the painkiller Vioxx was a bombshell, taking a

huge bite out of the stock price of the pharmaceutical giant Merck & Co.

Inc.

 

Aside from the obvious reminder that investing in the stock market can be

perilous, consumers, physicians and regulators can take many lessons from

the largest prescription-drug withdrawal in history.

 

A new drug is not necessarily a better drug. When cox-2 inhibitors, the

class of drugs to which Vioxx belongs, were first approved in early 1999,

they were touted as a " super Aspirin. " There was a widespread assumption

that cox-2 inhibitors worked better than over-the-counter medications.

That is not true. Ibuprofen (sold as Advil, Motrin) and naproxene work as

well as expensive cox-2 inhibitors, though they may have different side

effects.

 

All drugs have side effects. The big selling point of cox-2 inhibitors,

like Vioxx and its competitor Celebrex, is that they are less likely to

cause gastric bleeding. But the study that showed these wondrous results

turned out to be questionable: Researchers published results only from

their first six months of data because the data at the one-year mark were

less positive. While gastric bleeding is less likely with cox-2

inhibitors, this risk has to be balanced against another, greater danger

-- an increased risk of heart disease.

 

Beware of hype. Vioxx and its main competitor, Celebrex, are among the

most heavily advertised drugs ever. The marketing was brilliant, the

wooing of physicians masterful, and the media did more than their share of

early swooning. Doctors who relied purely on the marketing bumph and not

research failed their patients.

 

Pay attention to new research. A study published in the New England

Journal of Medicine in 2000 showed a clear association between taking

Vioxx and an increased risk of heart disease. Subsequent research

confirmed the association. Yet, the company did not act until a fourth

study, which was meant to determine if Vioxx could prevent colon cancer,

found an increased risk of heart attack and stroke.

 

The first media reports questioning the merits of cox-2 inhibitors

appeared as far back as 1999. So the information was out there.

 

Doctors should prescribe with caution. Cox-2 inhibitors such as Vioxx

should be prescribed to people with chronic pain only if they have ulcers

or other digestive-tract problems, a condition that applies to only about

10 per cent of arthritis patients. But the drugs have been prescribed

indiscriminately, for various conditions for which they have not been

tested.

 

Clinical trial results are not the final word. Vioxx was initially

approved on the basis of a study of 8,076 patients who took the drug for

up to 13 months. But that research focused on reduced gastric bleeding

among those on the drug, and did not look at heart disease. History and

common sense tell us that as more people take a drug in real-life

circumstances, and for longer periods of time, side effects become more

clear.

 

Regulators need to be more far-sighted. Approving a drug for sale should

be the beginning of the regulatory process, not the end. As evidence

mounted about the cardiovascular risks of Vioxx, Health Canada sat on its

hands; it requested only a small change to the label to tell users of the

risks. One in five Canadians over the age of 65 takes a cox-2 inhibitor.

They need better assurances that the drugs they are taking are safe.

 

Absence of evidence is not evidence of safety. It's troubling to hear

stories of many physicians switching their patients to two other cox-2

inhibitors, Celebrex and Mobicox, in the wake of the Vioxx withdrawal.

It's not known if these drugs also raise the risk of heart problems,

because the research has not been done. If we want safe, effective drugs

we need to invest more in independent research, and in monitoring.

 

Don't be wooed by numbers. The Vioxx example reminds us that drugs that

are very expensive and provide only a marginal benefit can be deemed

" successful. " Bear in mind that, to be approved, most new drugs need only

provide more benefit than a placebo -- in other words, that they are

better than nothing. The profitability and popularity of a drug should not

be confused with its clinical importance. In fact, they are often

inversely related.

 

The success of Vioxx was a triumph of marketing over science: It racked up

more than $2.5-billion (U.S.) annually in sales before science took the

upper hand once more. It remains to be seen if we have learned our lesson,

or if we will be seduced again when the next " newer " and " better " drug

comes along.