I finished Marcia Angell’s buzzworthy The Truth About the Drug Companies a couple days before school started, and highly enjoyed it. I’ve wanted to write a bit on it, but never had the time. (I still don’t have the time, but whatever.) Derek Lowe has a good counterargument , and I think he’s a pretty honest, genuine researcher.

Angell makes the case that Pharma isn’t all that innovative. Every company wants to have a cholesterol-lowering drug (statin), every company wants its own Viagra. These are called “me-too” drugs. While I _do_ think there are *way* too many “me-too” drugs, I don’t think Angell acknowledges the fact that it’s good to have several versions, to account for genetic differences in patients, allergies, adverse side effects, etc. (She does acknowledge this, but too briefly in my opinion.) But the numbers don’t lie:

bq. Of the seventy-eight drugs approved by the FDA in 2002, only seventeen contained new active ingredients, and only seven of these were classified by the FDA as improvements over older drugs.

I think Angell’s examination of Pharma R&D is pretty good, too. I’m 100% sure that Dr. Lowe does quality work, and necessary work for bringing new drugs to market, but I think he downplays the importance of basic science research. The fact is that drugs _could not be discovered_ without the basic science done by universities, funded by the NIH (and therefore, taxpayers). She also goes through the processes by which AZT, Taxol, Gleevec, and Epogen. And two more bits:

bq. A recent study published in the journal Health Affairs reported than, in 1998, only about 15 percent of the scientific articles cited in patent applications for clinical medicine came from industry research, while 54 percent came from academic centers, 13 percent from government, and the rest from various other public and non-profit institutions.

bq. An unpublished internal document produced by the NIH in February 2000… revealed similar percentages. The NIH had selected the five top-selling drugs in 1995 (Zantac, Zovirax, Capoten, Vasotec, and Prozac) and found that sixteen of the seventeen key scientific papers leading to their discovery and development came from outside the industry.

It turns out that drug law allows the NIH to require drug companies to make drugs licensed from it “available to the public on reasonable terms,” but the NIH doesn’t enforce this. Angell also notes that the “$800 million per drug for R&D” number circulated comes directly from what Pharma told the researchers it cost–without releasing the documents for verification. If I were Pharma, I’d inflate my numbers, too. (The number is also doubled to include “capitalized cost,” as if the drug companies could be investing their money elsewhere instead of investing in R&D.)

We could argue R&D all day, but I think Angell is strongest in attacking the marketing procedures of Big Pharma. She goes after the slimy practices of patenting metabolites or isomers and marketing them as new drugs to consumers to create demand. (Nexium is the active isomer in Prilosec; Nexium was developed as Prilosec’s patent was running out. Clarinex is the metabolite created *by the body* when it digests Claritin. It was made for the same reason as Nexium.) One of the most amazing statistics in the book–Pharma has 88,000 sales reps currently; that’s one for every 5 or 6 doctors in the United States . Imagine if textbook publishers had a sales rep for every 6 teachers trying to push why their textbooks are better. If it’s a good drug, and effective, does it really need all this marketing?

Other good points:

* Pharma basically controls medical education, but they’re not in the education business. They’re in the drug-selling business. If they were in the business of education, they wouldn’t be giving it away for free. Pharma usually contracts out to medical education and communication companies (MECCs) to prepare the teaching materials, but they advertise to Pharma like this: “Medical education is a powerful tool that can deliver your message to key audiences, and get those audiences to take action that benefits your product.” Real educational.
* Pharma has more lobbyists in Washington DC than there are Congresspeople.
* Pharma created the fake group “Citizens for Better Medicare,” spending $65m to fight drug price regulations.
* Donald Rumsfeld was CEO, president, and chairman of a major drug firm. I had no idea!

Angell makes some good suggestions for improving the system: She notes that drugs should have to be compared to existing treatments. Right now, if your drug is any better than a sugar pill, it’s good enough. She also thinks we should do away with direct-to-consumer advertising (it’s already prohibited in most other advanced countries). We should also change the timing of patents (they should begin when the drug is released to market, not when first discovered).

You might not like some of her points, but I think most are fairly strong. Pharma is either in the business of selling drugs and maximizing its profits, or it’s not. I don’t buy for a second that it wants to provide education to patients or providers.

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