Thursday, January 25, 2007

Disease Mongering and Pharma Credibility


"Disease mongering" is a term that was coined by the late journalist Lynn Payer to describe what she saw as the confluence of interests by some doctors, drug companies, patient advocacy groups and media in exaggerating the severity of illness and the ability of drugs to "cure" them.

Disease Mongering -- Is it real or not?

The following examples of disease mongering were cited in the April, 2006 issue of PLoS:
  • Restless Leg Syndrome - Prevalence of rare condition exaggerated
  • Irritable Bowel Syndrome - Promoted as a serious illness needing therapy, when usually a mild problem
  • Menopause - Too often medicalised as a disorder when really a normal part of life
The organization that hosted the Inaugural Conference on Disease Mongering, produced the following video and distributed it via YouTube. It's quite well-done.



Sometimes, there is thin line between "disease mongering" and disease awareness advertising and PR (see, for example, "Disease Awareness or Disease Mongering?").
"[Disease Mongering] is exemplified mostly explicitly by many pharmaceutical industry-funded disease awareness campaigns - more often designed to sell drugs than to illuminate or to inform or educate about the prevention of illness or the maintenance of health." - PLoS
This past Tuesday, Neil H. Gray, Managing Partner, Healthcare Trends & Strategies, LLC, and I put together a "Point-Counterpoint" debate on the issues related to disease mongering and pharma credibility at the Patient Education and Disease Awareness Summit in Philadelphia. Neil and I have discussed this topic before in a Pharma Marketing Talk podcast, which you can listen to here.

For the Summit audience, we decided to take opposite sides to debate several questions, including:
  • Is it a real issue?
  • Lack of blockbuster drugs in pipeline a factor?
  • Influence of DTC advertising
  • Impact on pharma credibility
You can find more details in the PPT presentation here.

One of the main tenets of disease mongering is that pharmaceutical companies are putting sales potential & profit before patient health when deciding what drugs to develop. A recent survey by PricewaterhouseCoopers ("Recapturing the Vision: Restoring Trust in the Pharmaceutical Industry by Translating Expectations into Actions") showed that consumers and pharmaceutical executives are far apart on what really motivates the drug industry. Take a look at the following chart prepared from survey data:

"Pharmaceutical companies need to demonstrate a better balance of their primary healthcare mission with their fiduciary obligation to shareholders through patient-focused behavior. Research has shown that a 5 percent positive change in corporate reputation translates into a 3 percent to 5 percent positive change in market capitalization." -- Peter Claude, a partner in PricewaterhouseCoopers Pharmaceutical and Life Sciences Advisory Services Group
Disease mongering may be just one more nail in the coffin of pharma credibility, but it will become a more important factor as the industry adapts to weak pipelines for new innovative drugs and must find new indications for old drugs.

Survey
I am interested in your opinion. Please take my survey. After completing the survey you will be able to see a summary of results (de-identified, excludes open-ended responses and comments that may identify the respondent). You can also use filters to examine results from different subsets of respondents (e.g., pharma company employees vs. non-pharma people, etc.).

Disease Mongering -- Is it real or not?

4 comments:

  1. John, you and I have gone around on this before, and back then, as now, your clincher was the point about pharma companies "deciding which drugs to develop."

    If drug development were a totally free choice -- like spinning the globe and poking a finger down on a random spot then just going there -- your point would carry a lot of weight.

    But drug development is typically much more constrained in any company by considerations such as (a) the compounds, molecular targets, and/or broad lines of investigation they have already established in drug discovery (no company can afford to take on the universe of potential candidates; (b) the diseases for which basic scientists currently have plausible hypotheses of potential therapeutic mechanisms (many diseases are still black holes in this regard); (c) the basic patents that a company already has (or doesn't); and (d) new uses for agents the company has already developed (e.g., an antihypertensive that also has beneficial effects on ED; an anticonvulsant that also alleviates neuropathic pain; or an anti-Parkinsonian that also is beneficial in Restless Leg Syndrome).

    Should drug companies be expected to forego bringing these drugs to market for new indications that are deemed by some people to be "trivial" or "overmedicalized"?

    Of course they will make additional revenues on these additional indications, but patients with currently underserved conditions will also have a treatment they would not otherwise have.

    I might observe,in passing, that I have never heard anyone who actually suffered from RLS, IBD, or severe vasomotor symptoms of menopause describe their own conditions as trivial. Nor have I heard physicians who actually treat these conditions on a regular basis do so either. One might want to check with those who have first-hand experience before dismissing them.

    Like Rumsfeld's Defense Department, pharmaceutical companies go to market with the drugs they have, not the ones they wish they had. (Though hopefully the researchers back in the labs are working on those.)

    Critics of the industry (and I count myself among them from time to time) might have more effect if they were more nuanced in their criticism -- aiming, for example, at mass DTC inappropriate to conditions targeting only specific populations (who would better be reached on the Internet) or "disease-awareness" campaigns for conditions in which there are no consumers unaware of their conditions and who have no legitimate role in selecting the therapy (such as Medtronic's current DTC campaign for implantable cardioverter-defibrillators) rather than unloading a scattershot attack on so-called "disease mongering."

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  2. Thanks for your comments Bruce.

    First, don't get me started on Rumsfeld. I think any anology between how the drug industry does business and how Rumsfeld ran the Pentagon can only hurt the industry further in the eyes of the American public!

    Again, I know you are very close to this issue having GSK as a client I beleive. I do not doubt you have seen many real cases, but your situation is unusual -- it's what you focus on maybe every day. That's your world.

    In my world, there are other, more pressing medical conditions than RLS that need the same kind of research and disease awareness money that pharma is spending on RLS. And now BI is coming out with a competitor (dare I say "me-too") drug for RLS!

    So, again, the question is NOT whether RLS, IBS, etc. are REAL medical problems; they are. It's more about how MUCH of a problem these are and does the industry EXAGGERATE the problem to pump up sales? While I may believe this to be true, I am also asking the question so that I hear all sides. I hope, therefore, that you have taken my survey.

    You point about unnecessary DA programs is interesting, especially in the medical device area. I hope to write more about this in future blog posts. All the ads I have seen, however, are branded DTC ads rather than true DA ads.

    While we're on the subject, I have a question. In the Medtronic ad you mention, the ad states that there are "risks" but does not list the specific risks as an Rx ad must do. Does the FDA regulate medical device DTC differently than Rx DTC in terms of what risk information must be included?

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  3. Actually, GSK is one of the few companies in the industry that isn't a client, so my comments about RLS are free from "commercial bias."

    I want to bear down on the R&D issue a bit more, however, if you'll indulge me.

    The thing about Requip (and Mirapex at BI) is that they weren't developed from scratch for RLS. They were already on the shelf for Parkinson's. There's some additional expense for a Phase IV study in support of the new indication and the SNDA applying for it, as well as for marketing the new indication once it is approved -- but nothing like what it had already cost the companies to discover the ropinirole and paramexipole molecules and take them through pre-clinical, Phase I, II, and III trials in the first place. Those were sunk costs.

    The new indications, if anything, have generated more revenues that can be reinvested in R&D in other diseases.

    Whether marketing has overplayed its hand once products like this are on-market is another question. (IMHO, in some cases they have and in others they haven't.)

    The public and the medical profession have every right to expect that marketing for prescription drugs be fair, balanced, and evidence-based. But that's a far cry (if a less effective headline-getter) from whether the drugs themselves should be available to physicians and their patients or not.

    ------

    In response to your device question, the differences between drug and device marketing regulations are currently small. But this parity is relatively recent. Historically devices were much less regulated than drugs (There were fewer of them, after all; they were less complex; and few, if any, of them were advertised directly to consumers.) so CDRH doesn't really have an organization comparable to DDMAC. But the same principles apply, and a branded device ad that omits risk information (especially a high-visibility ad in the Wall Street Journal) should not be surprised if a letter from Rockville shows up in the not-too-distant future.

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  4. Sorry about the GSK client mistake.

    Thanks for the clarification on device DTC. I'll have to find the WSJ ad you are talking about.

    BTW, if more and more drugs are "re-purposed" for different indications and the cost of R&D for the new indication is a fraction of the orginal R&D cost, then that's an argument to re-examine that $800 million per drug R&D price tag the indsurty is always talking about. Just a thought.

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