Re: vaccine prioritization during a pandemic

At 06:03 PM 5/18/2006, Mervin Bitikofer wrote:

>"...Of course, this is to ignore our stewardship responsibilities
>which I don't advocate at all."

@ Which you don't advocate at all? Really? ~ Janice

WSJ Political Virus
Why there's only one drug to fight avian flu.
http://www.opinionjournal.com/weekend/hottopic/?id=110007444

Saturday, October 22, 2005 12:01 a.m. EDT

Our political leaders keep telling us to fear the avian flu, and in
one sense they're right: We should all be scared to death about how
much damage our political leaders will do responding to the avian flu.

Consider Secretary-General Kofi Annan, who declared this month that
he hoped concern for "intellectual property" wouldn't "get into the
way" of procuring widespread vaccines for a potential avian-flu
outbreak. In other words, companies that make vaccines should abandon
their patents at Mr. Annan's whim. This kind of hostility to property
rights is precisely the reason we now have a shortage of vaccines and
drugs to combat this potential pandemic.

[]

No one really knows how great the avian flu threat is. Public-health
officials have been warning about it ever since new studies suggested
that the infamous 1918 flu outbreak originated in birds. Warning is
what these folks get paid to do. Other experts argue that 1918 was a
fluke and that the current avian virus is unlikely to become a mass
killer of humans.

Whatever the risk, some good will come out of this public alarm if we
use it as an opportunity to understand why the U.S. is now so poorly
armed to cope with a deadly flu outbreak. The reason is that our
political class has spent the past 30 years driving the vaccine
industry out of business with its own virus of over-regulation, price
controls, litigation and intellectual-property abuse.

The U.S. today has only three large vaccine makers--down from 37 in
the 1960s. This is the reason that, as recently as 2001, there was a
shortage of eight of 11 critical childhood vaccines. It is also the
reason the U.S. fell drastically short of flu vaccine a year ago,
after a shut-down of one of two major flu-vaccine makers. And it is
the reason only one company, Switzerland's Roche, is being counted on
for a drug that would potentially protect against bird flu.

Despite these warning signals, Washington has done almost nothing.
One problem is the Food and Drug Administration, which puts safety
above developing rapid cures. Flu-vaccine makers face particular
difficulties because they must effectively gain approval for a new
product (for each new flu strain) every year. The vaccine is still
grown in chicken eggs--a process that takes up to eight months. The
industry has revolutionary new technologies--reverse genetics and
mammalian cell culture--that would dramatically reduce the time and
cost of development. Europe is moving toward products using these new
techniques, but the FDA refuses to adapt and allow more rapid approval.

The feds have also done their best to remove any financial
incentive--i.e., profit--for developing new vaccines. The Vaccines
For Children program, a pet project of Hillary Clinton back in her
First Lady days, has been especially destructive. The program now
buys more than 50% of all private vaccines, and it uses this
monopsony clout to drive prices down to commodity levels.

When one pharmaceutical company offered to sell a new pneumococcal
vaccine to the government for $58 a dose, the Centers for Disease
Control demanded a $10-a-dose discount. Politicians want companies to
take all the risk of developing new vaccines, but they don't want the
companies to make any money from taking those risks. Then the
politicians profess surprise and dismay that there's a vaccine shortage.

Vaccine makers are also a favorite target of tort lawyers, who've
spent 20 years trying to get around the 1986 Vaccine Injury
Compensation Program (VICP)--which was specifically designed to
protect vaccine makers from liability abuse. Senate Majority Leader
Bill Frist has been trying to update the VICP for several years, and
Republicans did pass a liability provision as a rider to a homeland
security bill in 2002. But three GOP Senators--Susan Collins, Olympia
Snowe and Lincoln Chafee--created a media ruckus and demanded that it
be killed. The Senators promised more debate on the subject, yet once
the headlines vanished so did their interest.

[]

The larger point is that if politicians want private industry to
develop new cures and vaccines, they can't steal their patents or
confiscate their hope of making money. Private companies developed
the AIDS drugs that have extended millions of lives, but countries
like Brazil want to force those companies to give the drugs away at cost.

The solutions to getting more vaccines aren't complicated: Push the
FDA for faster approvals, shield companies from tort robbery and get
the government out of the business of buying routine vaccines.
Politicians can't be held responsible for knowing when the next
animal virus will strike the human race. But they will be responsible
if their hostility to business leaves us unable to cope with its consequences.
Received on Fri May 19 14:46:14 2006