Monday, July 14, 2008

Messin' With People

Should news stories about new unproven innovations in medicine be reported in the mainstream media as though they were already safe and effective?

It's an age-old problem, but one that warrants revisiting.

Certainly for the companies developing the technology, there is a desire to find patients who might be good candidates for a clinical trial that tests the new device. Companies have limited budgets to negotiate the complicated regulatory environment of the Food and Drug Administration (FDA) in their quest to acquire approval for the sale of their device. So if a little "press release" escapes to the media about the new technology, well, all the better.

For the researchers, there are often powerful financial and academic incentives to being the most experienced individual in medicine with a new technology is launched: patients learn of one's expertise and the researcher gains first access to the data from the clinical trial permitting an opportunity for the researcher to be "first author" on the sentinel paper describing the technology in a major medical journal. Reputations are made in our profession by such notoriety.

Hospitals and research institutes, too, are constantly looking for more funds to grow their "foundations." Donors are urged to contribute to their next endeavors, holding their best and brightest researchers forward at their rubber-chicken fund-raisers.

For news agencies, too, the push to acquire new and interesting content for their readers and viewers improves readership and advertising revenues. Nearly always, the news outlets are interested in the "human interest" aspect of the technology: how does it affect the Average Joe? So they seek out a patient who has benefited from the technology to tell the story. "Doctor, do you have a patient who could describe their experience using this new gizmo?"

And there begins the problem.

Well-meaning doctors gush forth with the name of their favorite patient experience. The patient is called, tells the "Best Story Ever" and is affable and approachable. The media bring their lights, cameras, and sound equipment to the hospital. Patients and doctors feel important, valued. The marketing opportunity, the public relations benefit, the cache' of being the most cutting edge - it's all so sexy. Everybody's happy. Ahhhh, the glory! What's not to like?

Unfortunately, plenty.

There is much to lose by such PR. This practice of early reporting of technologies before they are proven safe or effective introduces unprecedented bias in to any trial: bias for the research subjects, bias of the researcher's perceptions of the technology, and bias for the public at large. The patient who didn't fare so well is never brought forward - this would too unseemly for the institution, the doctor-researcher, and the company's aspiration to sell their device. Unless trials are prospective, randomized, multi-center trials, it is rare to have negative results reported in the literature, since it is much harder to right about what went wrong than what went right. Who wants that scarlet letter on their resume'?

Clinical researchers have an obligation to tell our patients the good, the bad and the ugly about any new innovation. Certainly no one wants to short-change the opportunity for patients to know about new innovations that might help their condition. But a 90-second feel-good sound bite in the media is just not the place to do that.

Ever.

-Wes

3 comments:

Anonymous said...

Naw, I think spreading a little hope is more positive than risking that a researcher becomes biased, and who cares if the public has another medical bias. Perhaps bias by a research participant is possible, but I would think a good researcher can work around that. We all go through life with hopes that are not rational and that is not all bad. I do agree, however, that The Red Violin was a fine movie

Rogue Medic said...

Dr. Wes,

Very well put. I think that we downplay the bias that researchers bring to all research, even the unpublicized. We need to work to recognize the biases we are not aware of.

anonymous,

Bias is what holds back medical advances. Bias leads to adoption of drugs or treatments that are harmful. Eliminating bias is one of the most important requirements of science.

Dr. Val said...

I totally agree with you, Wes. The "good" is sexy... "bad and ugly" not so much. Also, small trials are inherently likely to demonstrate false positive results:

http://www.revolutionhealth.com/blogs/valjonesmd/false-positive-resear-9991

As a physician who cares about the truth, I have to say that this Internet age brings with it some disadvantages and advantages. False positives spread like wild-fire and become gospel - thus fueling the snake oil movement. Yet bias can be outed more effectively than ever - and the things once done in secret are now fully exposed.

The best we can do is continue to be voices of reason, and express our concerns broadly. Those who have ears to hear, will hear. :)

Cheers,

Val