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December 22, 2006
Truths About Pharma
A new report out of the GAO sheds some useful light on that majestic pharmaceutical industry everyone's always talking about. The GAO was asked to look into the industry's trends because, despite R&D increases over the past decade, there's been a sustained drop in the number of genuinely new drugs being submitted to the FDA. The culprits? Well, among other things, entirely 68 percent -- more than two-thirds -- of the drug company's new applications are for "me-too" drugs, knockoffs of other company's blockbusters with enough molecular differences that they evade patent restrictions. Such spending, reports the GAO, is safer than socking money into so-called "New Molecular Entities," the drugs with the potential to offer new treatments. Going for new blockbuster drugs (drugs capable of generating $1 billion a year) or knockoffs of old ones is the easier road to profits.
Other culprits are a lack of qualified research scientists, technological hurdles, and the patent system, which allow for exclusivity on minor changes or new uses for old drugs, thus disincentivizing new research. All fair stuff. But this is an industry driven, as one would expect, by profit, not a desire to find awesome new drugs to better the world. That's for the good -- we need the pharmaceutical industry. But some better and more stringent bargaining by Medicare wouldn't harm things much, and if you channeled that money back into academic research -- and possibly created a new government pipeline through the NIH for translating molecular discoveries into drugs -- you could do quite a bit of good.
At Tapped, too.
December 22, 2006 in Health Care | Permalink
Comments
...knockoffs of other company's blockbusters with enough molecular differences that they evade patent restrictions.
This also creates competition and lower prices. At one time, you only had Lipitor. Now there are dozens of statin drugs available. Same with viagra and it's knockoffs.
Try this:
Among the
study’s key findings were the following:
The full capitalized resource cost of new drug development was estimated to be $802 million (2000 dollars). This estimate accounts for the cost of failures, including research on compounds abandoned during development, as well as opportunity costs of incurring R&D expenditures before earning any returns.
When compared to the results for previous similar studies, the R&D cost per approved new drug increased 2.5 times in inflation-adjusted terms.
After adjusting for inflation, the out-of-pocket cost per approved new drug increased at a rate of 7.6% per year between the 1991 study and the current study. The annual rate of growth in capitalized cost between the two studies was 7.4% in inflation-adjusted terms.
While costs have increased in inflation-adjusted terms for all R&D phases, the increases were particularly acute for the clinical period. The inflation-adjusted annual growth rate for capitalized clinical costs (11.8%) was more than five times greater than that for pre-clinical R&D.
Posted by: Fred Jones | Dec 23, 2006 8:07:56 AM
...knockoffs of other company's blockbusters with enough molecular differences that they evade patent restrictions.
This also creates competition and lower prices. At one time, you only had Lipitor. Now there are dozens of statin drugs available. Same with viagra and it's knockoffs.
Try this:
Among the
study’s key findings were the following:
The full capitalized resource cost of new drug development was estimated to be $802 million (2000 dollars). This estimate accounts for the cost of failures, including research on compounds abandoned during development, as well as opportunity costs of incurring R&D expenditures before earning any returns.
When compared to the results for previous similar studies, the R&D cost per approved new drug increased 2.5 times in inflation-adjusted terms.
After adjusting for inflation, the out-of-pocket cost per approved new drug increased at a rate of 7.6% per year between the 1991 study and the current study. The annual rate of growth in capitalized cost between the two studies was 7.4% in inflation-adjusted terms.
While costs have increased in inflation-adjusted terms for all R&D phases, the increases were particularly acute for the clinical period. The inflation-adjusted annual growth rate for capitalized clinical costs (11.8%) was more than five times greater than that for pre-clinical R&D.
Posted by: Fred Jones | Dec 23, 2006 8:08:18 AM
This also creates competition and lower prices.
That makes sense. Don't know if it actually works, but it ought to. Could still use more truly new drugs.
Posted by: Sanpete | Dec 23, 2006 2:38:17 PM
...knockoffs of other company's blockbusters with enough molecular differences that they evade patent restrictions.
There are no "one-size-fits-all" drugs. People are so different when it comes to their metabolism, genetics and physiology that the "molecular differences" offered by the pharmaceutical companies when it comes to any particular class of drugs give physicians effective options to offer their diverse patient populations, expanding the efficacy spectrum.
And if we can successfully align the so called self-serving motives, such as making a profit, with the more altruistic motives, such as "bettering the world", would there be any point in continuing to denigrate the supposed lesser motives?
Posted by: dr. david | Dec 24, 2006 2:01:55 PM
This also creates competition and lower prices.
Which is why the US has famously low prescription drug prices.
Posted by: Alon Levy | Dec 24, 2006 6:45:50 PM
Which is why the US has famously low prescription drug prices.
Usually, I like your comments. However this one just doesn't make sense. "Cheap" or "Expensive" are relative terms. Take into account availability. Think Canada develops a lot of the drugs they sell cheaply?
I would rather have them available a a price than unavailable at any price.
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