Sunday, August 15, 2010

Yes, PhRMA Can Be Considered A Bad Player

Recently, over on one of the site's contributors wrote a post asking if drug companies and the PhRMA industry deserve to be considered bad guys/bad players in health care.  The writer's answer is no, PhRMA and drug companies should no be considered villains.  He notes the profit the companies make, but defends this on the need to make profits off of new products in order to ensure the ongoing supply of new medications and treatments for illnesses.  He contends that without such financial security, pharmaceutical companies will stop pushing the boundaries of drug development and instead will produce a large number of "me-too" drugs that offer little added value to health care.

Unfortunately, the author does not seem to accurately appreciate the true environment in which big PhRMA operates.  Marcia Angell, in her book The Truth about the Drug Companies has already undercut most of this post's author's claims.  Angell points out that much "research and development" (R&D) money spent by PhRMA is spent on turning out nothing but me-too drugs.  Do we really need a 7th or 8th cholesterol pill, or the 6th member of an established class of blood pressure pills?  It's  true that these meds may provide incremental benefits for a small number of people, but they truly offer precious little to our choices of drug therapy.  Even worse, many of these me-too medications are small chemical tweaks of the companies' own medications that are going off-patent (meaning the company will make much less money off of them).  So, we get Nexium as Prilosec goes generic, Pristiq replaces Effexor, Clarinex picks up for Claritin.  There is no convincing evidence that these medication changes benefit health in any way, but they cost much more than the generic versions the are trying to supplant and keep the patent's profits safe for a while longer.  However, all these me-too drugs and second generation patent-extenders have to be treated as new medications, resulting in significant R&D costs that increase medication costs and do not really improve anyone's health (outside of the financial health of the companies and investors).

The writer laments that if we demonize PhRMA we might end up with "Another drug for heartburn that is no better than all the others on the shelf" or "lots of drugs that we don’t really need."  However, somehow he doesn't realize that we are already exactly there--because PhRMA can make money hand over fist under this system.  New meds are compared against placebo (no treatment) instead of being tested against already-established treatments.  So long as the new med is literally better than nothing, then it can be approved and marketed.

Even worse, truly cutting edge research is usually too expensive for PhRMA to pay for on its own.  Instead, this type of research is often government-funded (including NIH funds) and is carried out in universities (including state-funded universities).  Once the research gets close to a point where it can be leveraged into therapy, PhRMA can buy the patent and develop their medication.  Then, they can sell a product developed with public money right back to us with a much higher price tag.  Maybe PhRMA is working on that vaccine against cancer the author mentioned.  I doubt it.  More likely, they're waiting until NIH and/or university-funded research gets close, then they'll swoop in and take the credit and the profit.

We also get lots of lifestyle medications that help symptoms but don't necessarily save lives or improve health very much.  Medications for heartburn (such as Nexium), allergies (Clarinex), erectile dysfunction (Viagra) and various cosmetic uses (such as Vaniqa) are incredibly expensive and cost much money to develop but typically offer minimal benefits in the big picture.

So, no: I don't feel bad about attacking big PhRMA.  I have no worry that they will suddenly cease their "lifesaving" R&D because I think relatively little of what they do qualifies as such.  (I can't tell you how much of PhRMA's R&D is true fundamental research--they haven't released that info in the past.)  Instead, I look at the ridiculous costs for me-too drugs offering little added value.  I look at the fact that new cancer treatments can cost tens of thousands of dollars yearly.  I look at PhRMA's aggressive direct-to-consumer advertising.  And I look at the paucity of genuinely new developments that would stand to benefit the millions of people across the world facing life-threatening infections and chronic diseases that happen in places where people have no money.

The big PhRMA industry is a devil's bargain.  We don't have any other method in the US of getting medications produced and made available because the free market system calls for private industry filling this role.  So that's what we're stuck with, even when pharmaceutical companies are suddenly unable to supply life-saving medications.

I do want to note that I do NOT consider all the people who work for PhRMA to be bad people.  I have very good friends who work in the industry in various capacities.  But I think that PhRMA's role is a flawed one from the very top, and no number of committed and honest and hardworking people can cancel out the fact that the industry as a whole is a bad actor.

So that's the system we have, and those are the limits we face.  But let's be honest and forthright: for the occasional positive impact, big PhRMA costs us an incredible amount of money for precious little return.  In my book--and in this age of new-found awareness of the importance of cost-containment and evidence-based medicine--I feel this is enough to earn PhRMA a bad-guy label.

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