Monday, July 25, 2005

Company privacy and bird flu antivirals

One reason it is hard to know how available the antiviral drug Tamiflu will be if there is an influenza pandemic is that its sole maker, Roche Pharmceuticals, won't reveal its own manufacturing capacity (news details from American Society of Health Pharmacists News). In an investor's conference call on 22 July, Chief Executive Officer William M. Burns said:
"We've never actually released what our capacity is, nor do we intend to," Burns said from London. "The question we ask governments is, 'What do you want?' And if you give us orders, we will ensure that we put in place the supply chain to meet that" demand.
The US currently has a pathetic 2.3 million treatment courses in its "Strategic" National Stockpile (the SNS). Maybe we need another strategy just new stragetists). Roche revealed that in May DHHS signed a "nonbinding letter of intent" to buy another (pathetic) 3 million treatment courses:
This amount is far below the 133 million treatment courses that the National Vaccine Advisory Committee and the Advisory Committee on Immunization Practices agreed on Tuesday is the optimal amount to stockpile for pandemic preparedness.

Andrew Pavia, chair of the Infectious Diseases Society of America's Task Force on Pandemic Influenza, told the committees that the minimum amount of oseltamivir needed for "a robust public health response" is about 40 million treatment courses, an estimate that is far above the amount currently being publicly discussed for the stockpile.


Some countries, according to Roche, have contracted for enough oseltamivir to treat 20–40 percent of their populations during a pandemic.
Let's see. At some point in the mid future, the US will have 5.3 million courses of treatment. There are about 300 million people in the US, so that's enough for--maybe 2% of the population? I guess US planners dropped a decimal point somewhere. Too bad we don't have a No Health Planner Left Behind Act.

Roche can still do the numbers:
"My dream scenario is that a government orders 5 percent of the population per annum over a five-year period and builds up to the 25 percent" of the population, Burns said. Because the drug has a five-year shelf life, he added, a country ideally would make a purchase for year six and "write off" the year-one purchase, treating it "like an insurance policy."


Burns said that Roche reported $450 million in oseltamivir sales for the first half of this year, about half in seasonal product sales and half for pandemic stockpiling. The company expects to record a further $235–275 million in pandemic sales for the remainder of the year.
But the skies are not cloudless for Roche. For one thing, there is another competitor antiviral that works by the same mechanism, although it has to be administered in a dry powder inhaler, considered a significant disadvantage by some. That drug is Relenza (generic name, zanamivir). It is marketed by pharmaceutical giant GlaxoSmithKline.

Big Pharma would have us believe they need their obscene profits to finance research and development costs for drugs such as these, but both Tamiflu and Relenza were developed by other, smaller companies and licensed to Roche and GSK. In both instances, the smaller companies are unhappy at the lack of zeal in marketing them until the pandemic threat boosted sales. In the case of Roche, the developer Gilead Sciences is seeking to terminate their exclusive license agreement. In the case of GSK, the developer is an Australian firm, Biota Holdings Ltd., who is suing them for alleged dilatory marketing practices. It seems both developers have awakened to the pandemic Golden Goose and want better deals.

These four companies deserve each other. But do we deserve them? GSK has not produced much Relenza either, admitting that currently it had no more than a million doses.
"Our global capacity could increase to about 41 million doses by 2008," [GSK's Andrew] MacKnight said. He added that the company "is interested in talking with the U.S. government and other governments about their requirements for the product for stockpiling."
2008. I'm sure we can wait until then. Someone please notify the influenza virus to stop mutating while GSK, Roche, Gilead and Biota sort out the legal niceties and can get the cash register working again.

Not that we will know anything about those legal niceties:
During an investors' conference call on Tuesday, Gilead Chief Financial Officer John Milligan declined to comment on the licensing issue. He explained that the dispute must, under the licensing agreement, be conducted in strict confidentiality.

"Consequently," he said, "we will not be providing status updates concerning the issues between Gilead and Roche until these issues are resolved."
Maybe someone should invoke the USA Patriot Act and take away their privacy, for a change. Then it might really be enhancing our security.