Clinton-care destroys vaccine production

By Aussiegirl

For the third year in a row some parts of the country are facing shortfalls of the current flu vaccine despite reassurances that more than enough doses are available. On Saturday I had to spend 2 1/2 hours waiting in a line at a supermarket in order to get shot number 41 of only 52 available at that site. For the third year in a row my doctor does not know if he will even be able to secure any vaccine, and tells me to check back in a few weeks or, to be safe, stand in line at the supermarket.

Supplies appear to be spotty, with some areas experiencing no problems and others experiencing shortfalls. Doctors are complaining that they are unable to get vaccine and that all available supplies seem to have been bought up by supermarkets, which offer mass clinic innoculations at their stores. In my local area, Safeway is one of at least 2 chains offering the shots. However this year, despite scheduling a regular number of clinics throughout October and November, they suddenly announced that they were suspending all further clinics. On Saturday I got one of the last shots they were offering. Others have found that depending on where and when they happened to go to a supermarket they were able to obtain one easily without a wait. But at others the waits are long and uncomfortable. The spectacle every year of elderly people, most with canes, walkers, oxygen tanks and other aids standing in long lines for hours is simply inexcusable. In addition, although supposedly plenty of vaccine is available, most supermarkets are giving shots only to high risk patients, those over 65 and others with chronic or respiratory illnesses.

And this is just a normal year for flu. This is not a pandemic of the avian flu that some scientists fear may become a reality -- if not this year then in the next 5 - 8 years. As this editorial points out, so far governmental and regulatory efforts have only led to more shortfalls and fewer companies willing to produce not only vaccines, but antiviral medicines.

Instead of threatening to use the military in order to enforce quarantines in case of an outbreak human-to-human transmissible avian flu (something which has not happened yet), the administration should instead turn its attention to the catastrophic state of vaccine R & D in this country, a scenario created by the Clinton policies of the 90's and current misguided attempts to regulate and control the vaccine industry. If I'm not mistaken, the Clintons are no longer in power, so why has the administration not addressed these concerns and rescinded those ill-conceived policies?

The surest way to face the problem of a pandemic of something like the avian flu is to quickly develop the ability to rapidly manufacture the requisite vaccine in large quantities. The current method, which is antiquated, involves the incubation of the isolated strain in chicken eggs, a process which takes 6 - 9 months and is technically difficult and cumbersome. It's also too slow to be of any help in the event of a sudden outbreak of avian flu. There are gene-splicing techniques that can quickly manufacture large quantities of vaccine, but these are currently expensive and companies are being hampered by governmental regulation and fears of frivolous litigation.

This editorial in the Washington Times points out all the problems we currently face in addressing this potential pandemic, or indeed any potential threat of viral outbreaks, including those caused by bio-terrorism.

One additional note, on a medical expert on pandemics who has seen computer runs of the potential for containing an outbreak of avian flu using the only currently available methods, i.e. isolation, quarantine and Tamiflu, did show that if all steps are followed an outbreak of the virus can be contained relatively quickly and confined to a relatively small area. One of the benefits offered by Tamiflu is that it prevents the infected person from passing on the virus to anyone else.

Destroying vaccine development

President Bush is urging vaccine companies — those that are left — to find ways to jump-start production of vaccines to shield the world from the avian flu. However, there is little the president can do to quickly reverse a decade of policies and litigation that has killed the vaccine industry just as surely as the avian flu will kill millions of people, particularly children, worldwide. Price controls on pediatric vaccines, increased regulation of vaccine development and Vioxx-like litigation have caused continuing shortages of vaccines for influenza and childhood diseases. They have also have scared away the investment needed to produce huge quantities of shots to contain the avian flu and other outbreaks in a timely fashion.
[...]A vaccine against avian flu is under development. However, we lack the capacity to produce and distribute it to the millions most in need. The virus — H5N1 — is mutating into a form that could spread quickly from human to human. Therefore, the vaccine currently being developed might be useless. The expertise exists to reconfigure vaccines to thwart new strains quickly, but that requires production capacity we do not have.

Over the last decade, instead of promoting vaccine development, we virtually destroyed it. First, the Vaccines for Children program — Sen. Hillary Clinton's dry run for national health care — froze prices on childhood shots — and demanded bulk purchases. That one policy has contributed to the shuttering of state-of-the-art vaccine facilities and the exodus of several large drug companies from the business.

Then in the wake of the anthrax scare, politicians, including Sen. Charles Schumer and so-called consumer advocates, called for the government to seize the patents of drug companies and give them to generic firms who in turn would produce antibiotics like Cipro . Since then, companies have largely shied away from doing any business with the government out of concern that their products would be next. So, now Mr. Schumer wants the United States and other nations seize the patents of companies that make anti-flu medicines such as Tamiflu and Relenza. Not only will such measures dry up investment in flu-fighting medicines, but generic firms are unlikely to have the know-how to safely reproduce such complex products or have the margins to take on the legal liability of producing a medicine that if not properly formulated could be either ineffective or deadly.

Next, safety fears — ginned up by trial attorneys and demagogues like Sen. Charles Grassley — have led the FDA to demand longer and bigger clinical trials and tougher manufacturing standards.

Despite such delays and the threat of a pandemic that will kill millions, the staunch allies of the trial bar are still blocking any effort to limit liability for problems associated with an avian flu vaccine. They want to "protect" consumers, at least those that are still alive after a virus sweeps across the world without a vaccine to stop it.

As a result, many small biotech companies with excellent technologies that could be applied in creating vaccines tailored to different versions of the avian flu and other pathogens are simply limping along. They are mostly losing money in pursuit of better science thanks to threat of class-action lawsuits similar to those being brought against Merck, which also happens to be one of the few large vaccine makers left in the world. They are stalled at the FDA. And the threats of price controls and patent seizures are greater then ever. We have no vaccines to fight off bioterrorism more than four years after September 11 and we are ill-prepared to fight the avian flu .

It is said that by failing to learn from history we are condemned to relive it. By persisting in policies and lawsuits that punish the vaccine industry we are condemning millions to death. At a time when medical progress is entering a golden age, we are virtually defenseless against the dark clouds of disease that, once again, threaten to encircle the globe.

Robert Goldberg is the director of Manhattan Institute's Center for Medical Progress and the chairman of the institute's 21st Century FDA Task Force.