Ezekiel J. Emanuel wrote an opt ed piece in this weekends Times about the shortage of cancer drugs.He says “Of the 34 generic cancer drugs on the market, as of this month, 14 were in short supply. Only the older but curative cancer drugs — drugs that can cost as little as $3 per dose — have become unavailable. Most of these drugs have no substitutes, but, crazy as it seems, in some cases these shortages are forcing doctors to use brand-name drugs at more than 100 times the cost.” The story is full of generalizations and does not address the real problem underlying problems of generic cancer drugs.
The piece states:
Only about 10 percent of the shortages can be attributed to a lack of raw materials and essential ingredients to manufacture the drugs. Most shortages appear instead to be the consequence of corporate decisions to cease production, or interruptions in production caused by money or quality problems, which manufacturers do not appear to be in a rush to fix.
Dr Emanuel even goes as far as to suggest that the price for some of these generic drugs be increased so that there is more of an incentive to manufacture theses drugs. That is simply wrong.
The reasons for manufacturing delays is primarily due to production problems that are very expensive to fix at generic manufacturers which are not used to that kind of investment. It is very expensive to maintain an manufacturing environment that meets FDA standards when it comes to the production of chemotherapy drugs. Add to this that there are only a handfull of FDA inspectors to cover the whole country and you have the root of the problem.
Recently Lilly announced that Gemzar revenues declined with second quarter sales falling 62% when it came off patent. The rate of decline of branded sales was not expected to be so fast and steep but costs are a big issue right now and a hot button for lawmakers, insurers and patients.
If the FDA wants to stop these shortages than they should not grand approval for generics until the manufacturer asking for approval has a plant inspection and is certified to produce the cancer drug.
Let’s also be clear about something; asking a company, any company, to maintain raw materials and a production line for an unprofitable product is not realistic. The answer does not lie in raising the price to make the drugs more profitable the answer lies in raising the price to ensure that companies have the money to invest in capital to keep the line up to FDA inspection standards.
Dr Emanual’s piece is long on conjecture and short on facts and is just enough to get patients, HCP’s and the media upset at the pharma industry rather than provide possible solutions. I have come to expect this kind of journalism from the Times as they have been anti-pharma for a long long time but it does little to provide answers.
- Opinion: Shortchanging Cancer Patients (nytimes.com)
- New mouse model for testing cancer drugs (medicalxpress.com)
- Dendreon Wounds Are Self-Inflicted, Not the Start of a Biotech Industry Virus (dailyfinance.com)
- Johnson and Johnson Cautions Doctors Not To Begin Treatments with Doxil Cancer Drug – Shortages from Manufacturer Boehringer (ducknetweb.blogspot.com)
- Crucial cancer drugs in critical short supply (cbsnews.com)