Editor's Notes:

This article raises the question of whether or not drug trials sponsored by pharmaceutical companies are trustworthy. Some researchers and industry critics, like Marcia Angell, worry that these trials are more about marketing than real science. However, these worries are, for the most part, probably overblown—primarily because, in order to enter the market at all, drugs must first pass strict FDA scrutiny and prove that they are reasonably safe and effective.

Marketing—as much as it irks some doctors—is an inescapable part of modern medicine because treatment for many diseases is heavily influenced by human variation—including genetics, environment, and even diet. Advertising and industry sponsored trials convey valuable information about treatments to doctors and patients that help guide the treatment process. This information is particularly necessary in the case of psychiatric treatment, where diseases like schizophrenia and severe depression are notoriously difficult to treat. Studies by pharmaceutical companies that compare rival products for these diseases—even taking into account subtle and not so subtle biases—expand treatment options and improve our understanding of patient variation. The Post notes that

Drug makers defend their studies, and [psychiatrist John Davis] emphasized that the drugs do help patients. But doctors, he said, cannot afford to take the results at face value. Sara Corya, medical director for neuroscience at Eli Lilly, a company Davis singled out for praise for the quality of its studies, said that conflicting results do not cancel each other out, and that they help clinicians understand the strengths of different drugs. Corya and Davis noted that Lilly has strict rules to prevent author-shopping.

"The reality is that even in head-to-head comparisons, study results will differ for a variety of reasons, some transparent, some opaque," added Mariann Caprino, a spokeswoman for Pfizer, whose antipsychotic drug Geodon did not perform as well as Zyprexa in two trials funded by Eli Lilly. Pfizer's own studies found that Geodon was superior to Zyprexa in one trial and inferior in another. "What this all means," Caprino said, "is there is no substitute for the judgment and experience of the clinician in selecting among a fortunately broad palette of medicines"...

What a clinician wants to know is whether the patient she is treating will get better on a drug, said Thomas R. Insel, director of the National Institute of Mental Health. "If they are not going to get well, what is the better approach? The public is less interested in statistical significance and more interested in clinical significance."

Insel's point is certainly well taken: better information about clinical efficacy should be the bottom line all studies aim at. But government sponsored studies are just as likely to be driven by subtle biases (like touting cheaper generics for Medicare and Medicaid programs) as industry studies.

Finding better ways of predicting individual responses through validated biomarkers—personalized medicine—would make clinical trials more transparent and objective, but the science behind biomarkers is still in its infancy. Until then, we will have to muddle along with the best tools we have, even though they can be maddeningly imprecise.

Editor's Notes:

After reporting nothing but negative reactions to the Medicare drug benefit for a number of months, the media seems to be moderately surprised that seniors who've signed up for it said that they are saving money and that "the paperwork [to join] was easy to complete."

Millions of senior citizens have not signed up for and do not know much about Medicare's new prescription drug benefit, but among those who have enrolled, three–quarters said the paperwork was easy to complete and nearly two–thirds said the program saved them money, the latest Washington Post–ABC News poll shows.

The findings underscore the challenge the administration faces in persuading large numbers of seniors to participate in and support the program, the largest expansion of a government social benefit in decades. But it also unmasks a political opportunity among older voters for President Bush and the Republicans if they succeed.

Part of the challenge facing the administration is that the media coverage—and partisan sniping by the Democrats—has been so relentlessly negative. This seems to be changing as seniors gain familiarity with the program. Although the program undoubtedly has its shortcomings during its early implementation, its principles—choice, competition, and extra help for impoverished seniors—are principles that should be extended to the entire Medicare program. That prospect, more than anything, is what has critics worried.

Editor's Notes:

Doctors are mad as hell about medical malpractice suits and aren't going to take it anymore. Or at least some of them aren't—and they're turning to contract law to try and stem the tide of tort in ways the courts have not.

Sixteen doctors at a women's health clinic in the northwest suburbs have begun using an aggressive new tactic to fend off malpractice suits. Patients at four WomanCare offices are being asked to sign a contract promising not to file "frivolous" malpractice suits.

Some patients have asked questions about the form, said WomanCare CEO Dr. Carl Cucco. "But no one has refused to sign," he said. Anyone who does refuse still would be treated. Cucco said the contract levels the playing field in malpractice litigation. "We want to play fairly, and most patients are very supportive."...

The patient contract is among the litigation defense tactics offered by a North Carolina company called Medical Justice Services. The company has signed up more than 1,300 doctors in 47 states.

Medical Justice CEO Dr. Jeffrey Segal said not all of his clients ask patients to sign the contract, although "more and more of them are using it." Few patients object to the contract, Segal said. "Most see themselves as rational and reasonable and not the type of person who would file a frivolous claim."

But Joanne Doroshow of the consumer group Center for Justice and Democracy said the contract is an "unethical and egregious violation of patients' rights. The purpose is to intimidate a patient to not file a lawsuit if injured in malpractice."