Wednesday, July 13, 2005

Oh, The Prices We Pay: Thalidomide for Cancer

The New York Times recently reported on the high prices paid for drugs to treat cancer, notably the newer "targeted therapies." Some examples included:
  • $54,000 per year for Avastatin, made by Genentech,
  • $31,000 per year for Terceva, made by Genentech, and
  • $25,000 for Thalidomid, made by Celgene.
The article shows how the prices of these drugs drastically ratcheted upwards in the 1990's, starting with Taxol, made by Bristol-Myers-Squibb, at $4,000 per year, starting in 1992, through Herceptin, made by Genentech, at $20,000 per year, in 1998, to Erbitux, at $100,000 per year, made by Bristol and ImClone Systems.
The article stated that these prices are unrelated to manufacturing costs, and simply based on what the market will bear. A biotechnology analyst, Geoffrey Porges, said, "it's sort of one of those things where everyone looks over their shoulder at everyone else, says, 'he started it, it wasn't me,' and it builds."
Of course, this raises the question of why those organizations whose goal is to control health care costs, particularly federal payers represented by the Commission for Medicare and Medicaid Services (CMS), and managed care organizations haven't been able to address this price inflation.
A notable example is Thalidomid, whose price is listed above. Thalidomid is thalidomide, a drug whose adverse effects in the 1960's lead to major reform of the US drug approval process. (For a background article on the history of thalidomide go here: Rouhi M. Thalidomide. Chemical and Engineering News, June 20, 2005. ) "Chemie GrĂ¼nenthal introduced thalidomide--under the brand name Contergan--to the German market on Oct. 1, 1957, as a sedative to treat insomnia as well as to reduce nausea associated with pregnancy." Richardson-Merrell had applied to introduce thalidomide, under the trade name Kevadon, to the US in 1960, but the application was held up by a diligent officer of the US Food and Drug Administration, because of inadequate documentation of drug safety. The drug never made it to the US market, because by 1961, there were widespread reports in Europe of babies born with severe deformities to mothers who had taken thalidomide. (For more background on the history of thalidomide, see the materials from the NIH here, and from the March of Dimes here.) Later, discoveries that thalidomide had anti-inflammatory properties lead to studies of its use in several severe diseases, including multiple myeloma.
Now, what can the possible rationale for charging $25,000 per year for the nearly 50 year old drug thalidomide for multiple myeloma, other than it is considered a new "targeted therapy?" The drug is a relatively simple molecule first sold, again firs sold almost 50 years ago. Its manufacture does not involve high technology. Celgene raised the price of thalidomide from $6.00 to $29.00 per 50 mg capsule from 1998 to 2004. The price of a 100 mg capsule in Brazil is $0.07.
So thalidomide becomes another poster child, not only for the production of serious birth defects that lead to reform of the drug approval process 40 years ago, but also for how those organizations who claim to control health care costs are willing to pay amazingly high prices for "high tech" health care interventions, even if they are just re-named low-tech interventions from the last century.

3 comments:

Anonymous said...

How about the "at risk of a failure" money and time it took to run the pre-clinical and clinical trials, the expense of running a controlled distribution system.

How much does it cost to make a copy of Windows Vista?

How much does it cost to train a doctor?

Anonymous said...

I just had to pay $107 for a 50mg thalidomide capsule. It seems that our executive branch and congress want to protect the drug and insurance companies at the expense of the citizens. If free international trade is good for our country, why not open access to drugs from Brazil or any other country that values it's citizens more than it's corporations.

Anon3 said...

How about the "at risk of a failure" money and time it took to run the pre-clinical and clinical trials, the expense of running a controlled distribution system.

-> Not nearly as much as the drug companies spend on marketing. If they are receiving federal funding (ie. tax payer funding), they are prone to overestimating costs. If they bought patent-rights from publicly funded University research, it won't cost them much more to do the trials. Another expense is spent on a legal team to pressure FDA approval and approval from other government agencies as well as patent protection in as many nations as possible.

In year 2000, Pfizer spent 39% of their revenue on marketing, advertising, and administration. They spent 15% on research and development. The remaining 13% was profit (a very large profit for a large cap. corp. by any standard). The rest is manufacturing, capital expenses, vacation/meals, etc. That sums up what you're really paying for.

Almost all large cap. pharmaceuticals can easily adjust marketing/advertising and bonuses to make up for revenue shortfalls.

The "at the risk of failure" research you're talking about is small capital drug companies or startups funded by venture capitalists or side revenue to patent a new drug that will make or break the company.

How much does it cost to make a copy of Windows Vista?

USD 6 Billion.

How much does it cost to train a doctor?

In medical school, at least as much as it costs to pay other doctors, school administration, and capital costs to train one. Guess which one paradoxically is the largest expense?