Out of whack
News about two popular arthritis drugs raise questions about how drugs are monitored and marketed in the United States.
Recent negative publicity about a couple of medications commonly prescribed to treat arthritis pain has raised some disturbing questions about the way prescription drugs are marketed and the process they must go through before being placed on the market.
The two drugs in question, Vioxx and Celebrex, are cox-2 inhibitors, prescribed to millions of Americans for arthritis pain. Unfortunately a study of Celebrex recently revealed an increased risk of heart attack and stroke at high doses.
In response to the news, Merck & Co. decided in September to withdraw its Vioxx from the market. Pfizer, the manufacturer of Celebrex, has decided to leave its product on the market, but in a bow to consumers, it decided Sunday to quit advertising the popular drug.
Although canceling the advertising is a laudable move, it doesn’t go nearly far enough. Huge amounts of money are being spent to try to stir up public demand for drugs by making vague claims to improve peoples’ lives by eliminating their suffering from maladies that sometimes aren’t even identified in the ads.
These advertising costs contribute to the high cost of pharmaceuticals and send people to their doctors demanding prescription drugs that may or may not be indicated for their condition. Pulling advertising for Celebrex helps put such drug recommendations back where it — and all such discussions — belongs: with doctors who know their individual patients’ needs.
In addition to emphasizing the importance of making informed, considered decisions about prescription drug treatments, the Vioxx and Celebrex situation also has raised questions about whether the federal Food and Drug Administration is doing a good enough job of reviewing drugs before allowing them to go on the market. Although a White House official said Sunday that the FDA was doing a “spectacular job” of protecting the public, an internal FDA survey released last week found that about two-thirds of the agency’s scientists aren’t fully confident about how it monitors the safety of prescription drugs. About a third of the scientists had doubts about the process for approving new drugs.
Pharmaceutical companies have an obvious motive to get potentially profitable drugs on the market as soon as possible. It’s the FDA’s role to make sure drugs aren’t released prematurely. It can be a fine line when the public is clamoring for quicker release of a new “wonder drug.” The FDA shouldn’t let drug releases be slowed by simple bureaucracy, but neither should it skip important steps in reviewing drugs before they are released to the public. It should be noted that it takes longer for prescription drugs to be approved for the U.S. market than for most other countries.
Americans have tremendous faith in the ability of the proper medication to remedy about any health problem. While that isn’t a realistic expectation, they have a right, especially with the prices we all currently pay, to expect that the prescription drugs they are taking have undergone enough study to determine they are reasonably safe or at least that any potentially dangerous side effects have been identified so they can be weighed against the benefits.
There’s something out of whack when millions of dollars are being spent to entice people to seek out the latest drug innovation while questions remain about the process for ensuring those drugs don’t do more harm than good.

