- The Washington Times - Thursday, April 17, 2003

Here's a story ripped from today's headlines. A mysterious flu-like disease with no known cure which originated in southern China in November hits Hong Kong in March. It kills dozens, and sickens and infects thousands there. It spreads, leaving that health-care system on the brink of collapse, and moves like wildfire throughout the world and to America thanks to travelers.
While doctors in China recommend an ancient brew of dead silkworms and cicada-skin, American doctors and the U.S. Centers for Disease Control and Prevention go through thousands of existing drugs in a fruitless search for a treatment or a cure. Then, when all hope is lost, one biotech company, AVI BioPharma, says it should be able to develop a drug that would attack the SARS virus within a week of receiving its genetic code, which researchers in Canada just discovered this weekend. The company uses a technique that disables viral genes and has already made experimental drugs for coronaviruses similar to the SARS virus that causes illnesses in cats and lab mice.
But then, the drug doesn't get made. A group of individuals dedicated to weakening the ability of private companies to produce bioterror countermeasures and other products essential to public health make it virtually impossible for the company to invest in and develop the drug. They threaten to challenge the price and patent of the drug. And they block any effort to protect the company from any lawsuits that arise from the product's testing or use. These groups fancy themselves as opponents of high drug prices. But, what they are in practice are the new bioterrorists organizations that through persistent tactics and organized resistance weaken our ability as a nation to respond to weapons of mass destruction and other public-health threats.
Sounds like fiction? First, meet the Prescription Access Litigation Project (PAL), which is suing to shorten the patent life of Cipro the leading brand drug used to treat anthrax earlier than its legal term to allow generic versions on the market. Decrying the inadequacy of the arrangement that the federal government just negotiated with Bayer, the project has organized consumer groups in eleven states representing over a million consumers to sign on to the litigation.
What PAL is really doing is fronting for trial attorneys awash in tobacco cash, and who are now seeking to bankrupt biotech and drug companies by suing for early termination of valid patents on a retainer basis. It acts as a holding company for plaintiffs' lawyers who have banded together and created war chests to help fund what they think will be very expensive litigation.
The law firms handling PAL's patent-killing lawsuits include those that have made millions suing tobacco firms. These firms and other companies work from a playbook that challenges the validity of every new patent, seeking to end its legal life as early as possible. Again, this has nothing to do with unlawful behavior. It is simply a matter of a law firm's trying to get state courts to rule that the patents are invalid and then get a percentage of the monopoly profit that the generic firms will get during the 180 days they will be able to sell their drug without any competition after the court ruling.
Trial attorneys have made it nearly impossible to introduce innovative drugs and vaccines to defend the homeland. Indeed, the threat of a class-action lawsuit is more certain than that of a bioterrorist attack, which is why no biotech or pharmaceutical company in its right mind will invest in countermeasures or small-market drugs without liability protection.
Consider what Scott Gottlieb of the FDA science adviser's office has to say about the growing risks of litigation, even as new drugs have become safer than everyday aspirin: "The bowel drug Lotronex caused fewer than fifty serious events in 300,000 prescriptions before it was withdrawn, and became the subject of costly litigation. Even drugs like aspirin, which cause hundreds of deaths each year, could not meet the safety standards patients expect today. All this has become a bonanza for lawyers, however, as our society gets more accustomed to taking medications for a wider range of problems. Bayer is facing more than 8,000 lawsuits after Bayer's widely used cholesterol-lowering drug Baycol was withdrawn from the market after being linked to about 100 deaths."
People who did not suffer any side-effects at all, however, are filing at least 6,000 of those lawsuits. How much will these lawsuits eventually cost? Bayer has reportedly paid about $125 million to settle the first 500 cases. As with tobacco litigation, a large slice of those payments goes to plaintiff attorneys.
Which explains why they are also fighting so hard to block any effort to include any liability protection for companies like AVI Biopharma. The drugs and vaccines they produce are more indispensable and safe then ever. They are also fatter targets, too. So, it is no surprise that the haters of capitalism and the bottom-feeders of the parasite economy have found common cause in bankrupting private-sector companies in pursuit of medical progress.

Robert Goldberg is director of the Manhattan Institute's Center for Medical Progress.

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