Why are we taking so many pills?

Big pharma is big business, says Greg Critser. The same marketers who sell cornflakes and deodorants now persuade Americans that they need drugs to solve problems from toenail fungus to shyness to acidic stomachs.

Mr. Critser, the journalist who took an alarmed look at Americans' expanding waistlines in "Fat Land," contends in Generation Rx: How Prescription Drugs Are Altering American Lives, Minds, and Bodies that pill popping in the U.S. has reached an all-time high.

That might not matter if there were no downside. But even as direct-to-consumer advertising has drummed up unprecedented demand for drugs, two defenders of America's health - physicians and the Food and Drug Administration (FDA) - have let down their guard.

The result, he says, has been tragic, with unsafe drugs such as Vioxx, which some feel may be responsible for as many as 100,000 deaths let loose on the market.

Beyond such headline-grabbing cases, Critser says, lies the unknown long-term effects of indiscriminate drug taking. The real clinical trials of many FDA-approved drugs, Critser says, are taking place among the unsuspecting Americans who are routinely using them.

Using friendly layman's language and some welcome humor, Critser manages to enlighten what could be a dense and disturbing subject. (After scolding the American Medical Association, he leads into the next section by wisecracking, "Now that the AMA has a surveillance camera trained on my house....")

He traces the roots of the high-profile drug industry scandals of recent years to decisions to deregulate the industry in the 1990s and make drugs just another consumer good to be aggressively marketed.

Quotes, like this one from drug company executives counseling drug reps on how to push a product on doctors, catch drug marketers at their game: "That's where we need to be, holding [the doctor's] hand and whispering in their ear, Neurontin for pain, Neurontin for monotherapy, Neurontin for everything ... I don't want to see a single patient coming off Neurontin before they've been up to at least 4800 milligrams a day."

Sobering statistics tell his story, too. A few examples:

• More than 100,000 deaths per year come from drugs that are taken as directed by a physician (not through misuse or overdose).

• Almost half of Americans take at least one prescription drug every day; 1 in 6 take three or more daily.

• Drug companies pay for about 90 percent of the continuing-education classes physicians must take.

• Washington has six times as many pharma-industry lobbyists as it does US senators.

• Of the 1,035 new drugs approved by the FDA from 1989 to 2000, more than half offered no significant new benefits over older drugs.

Today, prescription drugs "have become interwoven with the very notion of what constitutes health," Critser says. Pills are expected to prevent future diseases, wake people up, put them to sleep, improve all kinds of performance, and lengthen life.

A turning point came when Viagra, which failed as a pain-relieving drug, was found to have a marketable side effect, he says. Thus was born "a cultural revolution in a pill" that pushed drug ads into new territory, including being sold on TV during the Super Bowl and on the Internet.

The definition of a blockbuster new drug was established: a pill to treat (but not cure) a chronic condition, thus requiring its use for months, years, or even a lifetime.

What can be done? Critser summarizes ideas also touted by other reformers:

• Doctors should spurn all gifts from pharmaceutical companies - from free lunches to gift bags to phony "consulting fees." Says one doctor urging change, "Our system would never tolerate judges taking money from those that they judge, yet for some reason this doesn't apply in medicine."

• The FDA should stop accepting "user fees" from drug companies and return to its role as a regulator. It should establish a drug safety unit independent of its division that approves drugs for sale. And it should have the power to insist on safety studies after drugs reach the market to reveal any ill effects missed during earlier testing.

• The FDA should establish a comprehensive and compulsory registry for clinical trials - the tests that assess the efficacy and safety of drugs - so that companies can't hide unfavorable results. And it should require that new drugs show that they are superior to drugs already on the market.

• Direct-to-consumer advertising should be banned for the first two years that a drug is on the market until its safety can be better ascertained.

In the future, advances in genetics may be able to match patients and drugs much more accurately, better calibrating dosages and effects, and thereby reducing the chance of unintentional harm, Critser says. In the meantime, Americans should ask themselves if they really need to take so many drugs. The costs, he says, may be higher than they think.

• Gregory M. Lamb is on the Monitor staff