November 07, 2005
Roche's Patent on Tamiflu Under Attack
In the wake of reports by Taiwanese scientists that generic manufacturing of the flu drug Tamiflu (oseltamivir) isn't that difficult, James Love of the Consumer Project on Technology launched a blistering attack on the Bush administration's failure to rapidly build a stockpile of the drug in anticipation of a bird flu pandemic.
I remain somewhat skeptical about the need for stockpiling a vaccine against an as-yet-undermined strain of flu (the annual flu vaccine always comes out about six months after the strains that pass easily from human to human are identified; the much-feared avian flu H5N1 isn't easily transmissible and wouldn't be the mutation that causes a pandemic, should one occur). But stockpiling flu drugs make sense. While Tamiflu isn't very effective -- in its clinical trials, Tamiflu reduced the severity of fever and associated symptoms of flu by about a day -- even a minor reduction in symptoms could mean the difference between life and death when combating a killer strain of flu.
So far, the U.S. government has refused to negotiate with Roche to license its drug to generic manufacturers or force it to do so. Instead, it's relied on market mechanisms. If we just give them enough money, perhaps they make enough drug.
Here's CPTech's response, sent out over the weekend on their listserve, IP Health:
1. Roche has clearly exaggerated and mislead government officials
about the difficulties of manufacturing generic Tamiflu (oseltamivir
phosphate). Government officials like US Health Secretary Michael
Leavitt or Australian Health Minister Tony Abbott have relied upon
this self-serving inaccurate information, and rejected measures that
would enhance the public's security. From here on, government
officials must be held to a higher standard, and be expected to do
some measure of independent due diligence. It's their job to be
right, not simply gullible, when preparing for a possible pandemic.
2. There are many different entities that could play an important
role in expanding the supply of oseltamivir, including businesses
that are motivated by profit opportunities. So long as there exist
legal clouds over the ability market generic products, rational
investors will hesitate.
3. Roche has had plenty to time to figure out what its options are
regarding the licensing of the patents. There are too many
potential suppliers to undertake individual negotiations with each
company. Roche needs to simply identify the relevant terms it will
impose on generic suppliers and offer open licenses to anyone who can
comply. The Roche licenses should be simple, covering only a few
items. Roche needs to say what the royalty will be for sales in
different geographic markets. They don't need to address the issue of
product quality, other than to possibly require that generic
suppliers satisfy national regulatory requirements. If Roche is
concerned that some countries have inadequate regulatory mechanisms,
they should invite the WHO to qualify generic suppliers, like the WHO
does now for generic AIDS drugs. (The public will have more
confidence in the WHO than Roche for this task.)
4. Roche should not restrict generic sales to the stockpile market.
Roche has cut off private sales in many countries. Consumers should
have the opportunity to buy this drug, and Roche is clearly unable to
address the demand for the product. Government stockpiles are clearly
non-existent or inadequate in most of the world. The Roche prices are
also unaffordable for consumers in developing countries.
5. If Roche does not act now, governments should issue the
appropriate compulsory licenses in order to assure the competitive
generics sector they can legally sell generic copies of the drug.
Further delays by governments are not helpful, and increasingly hard
to defend.
6. Governments that do issue compulsory licenses need to consider
the appropriate remuneration schemes for the patent owners. CPTech
recommends a different system for royalties for government stockpiles
than for private sector sales. A system of contingent royalties for
government stockpiles should be considered, as CPTech has proposed
(James Love, October 28 2005, "A better way of stockpiling emergency
medicines," Financial Times, http://www.cptech.org/ip/health/tamiflu/love10282005.html).
question: Just read your article on Tamiflu. My question is simple-Is Tamiflu effective or not. One sentence states Tamiflu isn't very effective and the next states it may be a life and death difference. Tamiflu is like many other medications, if you don't have a decent immune systemt, it doesn't matter what you take, your body will not be able to fight off the infection. Maybe you have the research that I don't that shows Tamiflu actually attenuates mortality and if you do i would love to see it. thank you. (of course if your intent was to show Bush and Rumsfelf for the money mongering shit heads they are then i don't really care if you have any hard evidence since what they say and do are vastly different).
Posted by: Jeff at November 7, 2005 10:19 PMI made the assumption that a broad population's response to the drug would vary. The clinical trial average when Tamiflu was approved by the FDA in 1999 was a one-day reduction in symptoms of fever, bronchial distress, etc. These were people with seasonal flu, not people facing possible death from a killer flu.
I believe heavy dosing with Tamiflu against a killer flu would not be very effective overall, but if it it did ameliorate the some of the worst symptoms like high fever, bronchial pneumonia, etc. (which are what kill you, not the flu itself), it would probably move the survival curve slightly lower, which translates into the difference between life and death for some people. It's the difference between epidemiology and what happens to you.
Here's how that looks hypothetically: Say 50 out of 100 people die from this disease if left untreated. But if you give everyone the drug, only 49 die. If you're the one additional person who lives, then it may well seem like it is worth it to give a relatively worthless drug to a 100 people.
Posted by: Merrill at November 7, 2005 10:24 PM