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Flibanserin: Another Pre-FDA Approval Drug Hype

Money-happy pillThis week the FDA will vote on flibanserin, the much-talked-about drug for women with the condition called hypoactive sexual desire disorder or — because everything in sexual health needs an acronym like ED or PE — HSDD.

On the eve of the FDA vote, CBS last week ran still another story about flibanserin. This drug has received so much news coverage, you’d think it cures cancer.

And CBS did little more than promote the hype even more, saying FDA approval “could translate into a $2 billion market in this country alone” and then failing to challenge the disease-mongering estimate of “10 percent to 30 percent of women” with this condition. It all just goes along with the drug company’s efforts to build a demand before the drug is even approved. Read more »

*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*

Are For-Profit Healthcare Companies Inherently Less Ethical Than Non-Profit Organizations?

I was a little surprised by a recent reader comment suggesting that pharmaceutical companies are no different than tobacco manufacturers. While I am strongly opposed to misleading pharmaceutical marketing tactics, the bottom line is that most drugs have a legitimate therapeutic value. Tobacco, on the other hand, is a known carcinogen with no medical value that I can think of. This comparison, however, brought into focus a common underlying assumption: that for-profit companies are inherently less ethical than  non-profit and academic centers.

I’d like to question the tendency to absolve academic centers of any possible wrongdoing on the basis of their educational reputation or non-profit status. Of course, financial gain is not the only motivator behind endeavors, initiatives, and behaviors – though it may be the easiest to measure.

As a medical student I witnessed a sad example of academic misbehavior. Senior residents in the department of plastic surgery were performing liposuction procedures after hours for cash. When a patient experienced an infectious complication from a thigh liposuction procedure, an investigation ensued. The residents claimed to be putting the cash into the residency fund, to be used to support travel, lodging and participation in annual assemblies – therefore exonerating themselves of wrong-doing.

It is unclear if the department chair was fully aware of what the residents were up to, though he was reprimanded, terminated, and ended up teaching at another institution. The plastic surgery department lost its accreditation, and all of the residents had to finish their training elsewhere. As for me, I lost my mentor (the department chair) and ended up not pursuing a career in surgery. There certainly was a lot of fall out from that debacle on all sides.

A case of academic double standards was highlighted recently by Dr. George Lundberg in a Medscape editorial where journal editors claimed that continuing medical education (CME) courses should never be sponsored by for-profit companies. Meanwhile the journal accepted advertising from these same companies:

…The JAMA editors who wrote in 2008: “…providers of continuing medical education courses should not condone or tolerate for-profit companies…providing funding or sponsorship for medical education programs….” This is from a publication that, for more than 100 years, has been supported primarily by advertising revenue, mostly pharmaceutical. The editors will say “yes, but we follow rules to prevent bias or improper influence.” True. So do we, a for-profit company, follow rules that prevent bias and improper influence.

On the positive side, there are many examples of for-profit companies who cultivate a culture of environmental responsibility and charity – Ben & Jerry’s, SC Johnson, and Patagonia come to mind. And let’s not forget the foundations created by Bill and Melinda Gates, Warren Buffet and many others thanks to overflow from for-profit endeavors.

In the end, conflicts of interest, hidden agendas, and secret quid pro quos are a matter of individual character and corporate culture. The people who build a company (or a country) have more to do with its behaviors and processes than the simple label “for profit” or “non profit” or any assumptions made at such a superficial level.

We are all biased in many ways, both consciously and unconsciously. The best we can do is to strive for transparency. It may be best to judge each entity and/or individual by their degree of transparency rather than profit status, academic status, or subject matter expertise. For-profit companies can be highly ethical, and academic centers can be rife with undisclosed conflicts and questionable behaviors.

Healthcare organizations should not avoid or incur scrutiny based on their profit status alone. Bias comes in many forms – and the best we can do is work for the good of others in full knowledge of the influences around us.

Farewell To The Medscape Journal

On January 31, 2009 The Medscape Journal will be discontinued. One can only assume that the journal’s parent company, WebMD, could no longer justify the cost associated with a free, open-access, peer-reviewed medical journal that receives no income from advertisers or sponsors. The Medscape Journal’s budget has been supported by revenue generated from Medscape (the website), and their robust Continuing Medical Education (CME) business.

In these challenging economic times, American companies are taking a cold, hard look at their P and L spreadsheets and nixing the least profitable parts of their businesses. The inevitable “non-profit” casualties present an ethical dilemma. What will become of the noble pursuits that are based upon “doing the right thing” rather than making a profit?

There is no such thing as completely unbiased publishing (humans all have personal agendas – whether conscious or unconscious), though The Medscape Journal came about as close to it as any medical journal ever has. The journal is free to authors and readers, and provides 24-hour online access to both professional and lay viewers from around the globe. There are no advertisements or outside sponsors, peer reviewers work without compensation or specific recognition, and editors are paid a minimal salary (full disclosure: I know this because I was an editor for The Medscape Journal several years ago). CME credit is offered for articles determined to be of special relevance, but no articles are commissioned specifically for the purpose of CME.

The Medscape Journal is a wonderful experiment in high ethics. It espouses, in my opinion, the gold standard principles of medical publishing. Tragically, market forces (or perhaps the lack of perceived value by its own parent company) killed it. So what does this mean for medical publishing? If there is no economic model for “pure science” then are medical journals doomed to go the way of health media – promoting sensational or biased science for profit?

The answer is no. But we must tread very carefully now. The Medscape Journal is our proverbial canary in a publishing coal mine. Its inability to survive on ethics alone speaks to a growing lack of value placed on purity over profitability. We must soberly consider the facts: 1) The Internet creates the illusion that information is “free” and therefore subscription-based publishing platforms will end as viewers simply refuse to pay. 2) Advertisers are becoming more aggressive in their requirements – dynamic microsites and multi-media advertorials have replaced the old billboard approach, often blurring the lines between content and advertisement. 3) Search engines like Google are changing the way that health messages reach the public and scientists alike. The “impact factor” of research often lies in its marketing campaign. Important negative trials are buried under case reports, anecdotes, and news stories with snappier headlines.

So what are scientists to do? I suggest that those of us committed to science-based medicine join together in a united effort to harness new media tools for the public’s benefit. Let’s use social networking applications (blogs, Twitter, Facebook, online communities, etc.) to educate others about science, research, health claims, and potential biases. Let’s not be afraid of marketing scientific integrity – decades have already shown us how effective marketing can be for snake oil. If we don’t raise our collective voices – how will people get good information on the Internet? How will Google searches return highly ranked, sound information rather than sensational headlines?

Farewell to The Medscape Journal – and thank you for nearly a decade of honorable medical publishing. May the rest of us continue the vision, if only on different platforms.

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