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The Washington
Times
www.washingtontimes.com
By Scott Gottlieb
Published
October 15, 2004
It is looking more and more like the violations that led British drug
authorities to nix half the U.S. supply of flu vaccine were mostly process
problems, not widespread contamination of shots. In other words, the
company that made the vaccine was not trying hard enough to keep its
factory proficient and pristine.
The British
have always had a reputation for being fussy, but what works for selling
range rovers and raincoats is not considerate policy if it means a
lifesaving vaccine will be kept from patients who do not have an
alternative.
The facts will emerge after the
U.S. Food and Drug Administration finishes its own inspection of the
plant. Right now, nearly half of the nation's expected supply of flu
vaccine is not available this winter because the British government
suspended the manufacturing license at the factory in Liverpool that makes
it. The British drug authority, the Medicines and Healthcare products
Regulatory Agency, said it found vaccines with abnormally high levels of
bacteria in them.
But according to testimony
from Chiron Corporation, the American biotech firm that makes the vaccine,
and word seeping out from British drug authorities, Chiron "failed to
conduct operations in accordance with Good Manufacturing Practice
regulations of the United Kingdom," according to the company's statement
to Congress. In other words, the plant did not have enough controls to
ensure that vaccines remained free from contamination.
Early word is that only a very small portion
of the 50 million doses were actually contaminated. So, why hold up the
entire shipment? The British are likely to argue that they cannot tell
where in their production process the problems are coming from. Since they
cannot find where the contamination is happening, they cannot certify the
safety of any of the finished product.
True,
these are serious concerns. After all, the product here is a vaccine that
people will be injecting into their bodies. But these kinds of process
problems are far different from finding widespread evidence of tainted
shots. British regulators had a public-health obligation to salvage
whatever shots could be unsoiled while they continued to fix the plant and
look for the root cause of the problems.
In
some cases, even contaminated vaccines can be refiltered and cleaned. The
alternative is that Americans will surely die of flu this winter because
they could not get a vaccine. Now, even if the American regulators are
able to salvage some of the uncontaminated vaccines or clean up tainted
shots, releasing them on the heels of the rash British action would be a
tough sell. Liability concerns would keep Chiron from wanting the
unapproved lots used. And the FDA would still face a tough challenge
convincing people the shots are really safe and people should take them.
It did not have to be this way. Confronted
with manufacturing problems, the action that the FDA takes is always
weighed against its public-health impact. If closing an important drug
production line means people will go without lifesaving medicine, the FDA
forces the factory to operate under very close regulatory supervision
while it fixes the problems. But it lets drug production continue.
This was evidenced most recently in the FDA's
exhaustive efforts to bring the American Red Cross into compliance. What
was the agency going to do, turn off the U.S. blood supply?
The FDA also did a lot of handholding with
BioPort when it was having troubling bringing its plant into pristine
shape. BioPort, as the sole manufacturer of anthrax vaccine, was a vital
national-security asset.
In deciding what kind of
enforcement action to take against a firm that falls out of compliance,
the FDA sometimes seeks an injunction, which is a court order that tells
the company not to do it again. The court order also raises the stakes if
there are additional violations by threatening legal action. In the United
States, when the issue at stake is availability of an important medical
product, reason prevails.
Not in the United
Kingdom. The emerging perception is that the British were nitpicky here
because they could afford to be. They had no skin in this game. A full 90
percent of the vaccines that were coming out of the mothballed plant were
earmarked for the United States. The British will not be facing needless
disease and death this winter. Americans will.
Scott Gottlieb
is a physician and fellow at the American Enterprise Institute. Until
October, he was senior advisor to the head of the Medicare and Medicaid
programs, Dr. Mark McClellan. Previously, Dr. Gottlieb was Director of
Medical Policy Development at the Food and Drug Administration.
Copyright © 2004 News World
Communications, Inc. All rights reserved.
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