An article from TIME that everyone’s linking to

Thursday, October 22 2009

You know the one: “How Drug-Industry Lobbyists Got Their Way On Health Care“, by Karen Tumulty and Michael Scherer. It’s worth reading if you’re not familiar with the issue, but there are a couple of aspects important to patients that the authors don’t quite spell out. First, this bit:

But there’s a dilemma: policymakers want to foster cost-saving competition without killing the financial incentives that have put the U.S. biotechnology industry at the vanguard of medical science and without stifling the development of even more drugs that could save lives and eliminate suffering. Finding that equilibrium goes to the question of how long biotech firms should be guaranteed exclusivity, outside the protection of their patents, before copycats can begin using the data they have developed.

This is a somewhat misleading way of framing the dynamic. On the one hand, yes – patents guarantee profits, which spurs companies to innovate. But their innovations are not necessarily a net benefit to social welfare. Take the example of Remicade, J&J’s blockbuster biologic for Crohn’s, RA, psoriasis, etc. It made billions of dollars for the company, and led other companies to innovate new drugs, eg. Humira, Enbrel, Cimzia. Even though the new drugs are technically new, they all use the same basic mechanism; they’re all anti-TNF-α antibodies, which means they all work about the same and have about the same risks.

Biomedicine is so complex that each company can create a drug just different enough from the others to be awarded a patent, which protects them from generics and guarantees their ability to demand high prices. Then they market the drug to patients and doctors as if it’s the latest and the greatest. So the drugs all have patents, they are all expensive, and they all do pretty much the same thing: how is this situation better for consumers than were generics made legal? It’s not, as far as I can tell.

Moreover, the same companies ignored or abandoned promising research in other biologic and non-biologic therapies, and focused on the guaranteed profits from anti-TNF-α. If you can’t get TSO or J695 or LDN for your Crohn’s, it’s because there’s sure money in anti-TNF-α. Other drugs are slightly more risky from a financial perspective, even if they might ultimately be better for patients. There’s every reason to think that if we guarantee profits in biologics, that’s what we’re going to get. There’s no reason to think we’ve exhausted the possibilities of conventional therapies for most diseases, and biologics bring a whole new profile of side effects and risks that we are still learning about.

Second, there’s this bit:

That means it can be hard to find a truly independent viewpoint, though it often requires deep digging into the finances of advocacy groups to discover their ties. In July, one calling itself the National Health Council wrote letters to members of Congress “on behalf of 133 million Americans” asking for a minimum of 10 years of data exclusivity. The group boasts a membership that includes 50 of the nation’s largest patient-advocacy groups, including the American Cancer Society, Easter Seals and the National Kidney Foundation. But its board of directors reads like a Who’s Who of top pharmaceutical executives from Amgen, Pfizer, Novartis and Bristol Myers Squibb. Its 2007 tax filings show that almost half its $2.3 million budget came from PhRMA and drug companies.

This also means that when the ACS, Easter Seals, and Kidney Foundation talk about health reform – if ever – they do it with influence from the pharmaceutical industry. (Along the same lines, you might re-read this post about the National Patient Advocacy Foundation.) Which is to say, we can’t really trust advocacy organizations to speak solely for our interests of patients. Virtually all of them get money from pharmaceutical companies, and for many that is the largest source of funding. Many of them include pharmaceutical executives on their boards or advisory councils.

It is entirely likely that you will more for your medicine – a lot more – because your organizations were unable to stand up to Pharma. This is why it’s so important that patients speak up, make themselves heard, and don’t wait for their disease’s organizations to do it for them. They won’t. They can’t.

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