Headlines Matter
The New York Times reported this weekend that the National Institutes of Health has announced that it would be engaging in a billion-dollar effort to encourage the development of new pharmaceutical therapies. The Times' headline for this story sounded innocuous: “Federal Research Center Will Help Develop Medicines.” Fox News, in contrast, re-ran the Times story under the header: “Obama Creating Billion Dollar Gov’t-Run Drug Company.” I address the proposal in today's Daily Caller, in which I argue that the government should not waste time and resources making the NIH do something it is unsuited to; if HHS wants to advance the cause of pharmaceutical development, it should focus on improving the expensive, cumbersome, and uncertain FDA approval process.
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Re: Headlines Matter
Innovator pharmaceutical companies are in a real squeeze. The Hatch-Waxman Act provides low-cost generic drug competitors with a right of reference to innovator clinical trial data, dramatically hastening a drug's end-of-patent revenue cliff in the name of reducing consumer costs. Meanwhile, new drug development is ever more expensive, regulatory approval more uncertain and adequate reimbursement more unlikely. As revenue declines, R&D investment must likewise decline, leading to fewer breakthrough drugs and further revenue decline. Throwing a billion dollars at NIH will not reverse this industry spiral.
Edited on Jan 25, 2011 at 11:42amAug '10
Re: Headlines Matter
Can't you imagine what convoluted thinking will grip the HHS ?
Let's cure the symptoms of the common cold in fetuses so they won't be unduly uncomfortable as we demonstrate Roe v. Wade.
May '10
Re: Headlines Matter
Somehow we must get the government out of the business of going into business.
Re: Headlines Matter
George is right about the challenges industry faces, and I'm not sure how the new program will help.
I liked Kervinlee's pithy way of telling the government to stop it before it industrializes again.
Oct '10
Re: Headlines Matter
But Tevi... clearly the NIH IS doing something about the approval process. Once they develop the drug, they approve it. Nothing beats the one-stop-shop. And I'll bet you thought that every step taken by the Obama administration was designed to slow things down.
Edited on Jan 25, 2011 at 1:53pmOct '10
Re: Headlines Matter
I'm just now reminded of a somewhat surreptitious meeting I had in Saigon about 7 or 8 years ago, with the recently dismissed Health Department official who oversaw the polio vaccination program throughout Vietnam. He had been kicked out of the government because he discovered that the incidence of the disease began skyrocketing for no apparent reason. Once he looked into it, he found out that the medical labs were producing ineffective vaccines. When he started to make official noises, he was told that the weak vaccines would stay in use until they ran out.
Something to look forward to.
May '10
Re: Headlines Matter
There is one way that this can address a legitimate problem, though it is not the best way (a better way is to contract with academia).
Low-hanging fruit has largely been plucked- that is, single molecular entities that have therapeutic action for a significant portion of the population, 1) above the beneficial threshold, and 2) below the toxicity threshold.
To get most new benefits at a meaningful level, you need to combine chemical effects- which is why everyone is going after biologics (monoclonal antibodies, etc.)- because they use God's own method of combining synergistic proteins.
Intellectual property (IP) customs (George mentions) make pharmas reluctant to share proprietary single-action molecular entities with other firms because both parties want to own all the resulting IP. To get new benefits, you must combine a lot of different things in a near high-throughput screening environment, such as that used today to find anti-infective compounds.
The government labs can work neutrally with multiple commercial companies and work out IP sharing terms as a sort of "honest broker", not seeking IP rights for themselves. They already do that for some anti-cancer programs- this looks like an expansion of that.