Reply #2: Snopes is groovy

[teach1st]

http://www.snopes.com/politics/business/flushot.asp

Claim: The current flu vaccine shortage is attributable to a lawsuit handled by Vice-Presidential candidate John Edwards.

Status: False.

Example:

Origins: Two major problems with this political screed, which attempts to attribute a shortage of flu vaccine to a lawsuit handled to Senator John Edwards of North Carolina, the Democratic Vice-Presidential candidate:

Chiron, the corporation mentioned in this piece as an example of a "British company" that has taken over the manufacture of flu vaccine from American companies supposedly driven out of business by liability lawsuits, is not a British company. It is an American company headquartered in Emeryville, California, which last year purchased British vaccine maker Powderject and a flu vaccine plant in Liverpool, England.

American manufacturers did not produce flu vaccine until liability lawsuits made it impossible for them to continue doing so. Most American pharmaceutical companies got out of the flu vaccine market because a variety of factors (not related to lawsuits) make it an unattractive line of business:


Flu viruses mutate easily, so new flu vaccine formulas have to be made up every year.

Because a different flu vaccine is used each season, unsold doses cannot be saved and end up being destroyed (along with any potential profits).

The production of flu vaccine (and the requirement of meeting Food and Drug Administration standards) is a labor-intensive process. Flu vaccine is made by injecting virus into fertilized chicken eggs — each egg must be hand-inspected and hand-injected and produces only 4 or 5 doses of vaccine.

Because flu vaccine is a commodity (i.e., the same product can be made by many different companies) and much of the available supply is bought up in large orders by the government, the market price of vaccine — and the profit to be made from selling it — has been quite low. (The global market for vaccine is about $6 billion a year, while the global market for drugs is about $340 billion a year. Which of these two markets a pharmaceutical company should concentrate on is a no-brainer.)

Sometime within the next several years, the flu vaccine industry will switch to growing vaccine in cell cultures rather than eggs, a much easier and cheaper process. No new entrant to the flu vaccine market is going to spend several years and millions of dollars investing in a process that will soon become obsolete.
A recent article in the Washington Post chronicled the travails of Wyeth, one of many companies that has abandoned the flu vaccine market in the last few years:

For two decades, Wyeth made injectable influenza vaccine at a plant in Marietta, Pa. For the winter of 2002-03, it made 21 million doses in a labor-intensive, time-crunched process and shipped them to clinics and doctors' offices early in the fall.

But it turned out a lot fewer people wanted it. Flu vaccine can't be saved from year to year. So, sometime the next spring Wyeth threw away 7 million unsold doses, for a loss of $30 million. It then quit making flu shots. It eventually closed the Marietta plant, which once employed 800 people.

But Wyeth wasn't out of the flu vaccine business — yet.

It was a partner with the Maryland biotech company, MedImmune, in making what they considered the flu shot of the future — a "live" virus vaccine squirted up the nose. They made 5 million doses of FluMist for last winter, the product's inaugural season. But FluMist never found its market. Only 450,000 doses were sold; the rest were thrown away.

Over three seasons, Wyeth lost $50 million from unsold flu vaccine. It was also facing millions of dollars in required improvements to keep its plant up to standards required by the Food and Drug Administration.

Last April, Wyeth pulled out. It was done with flu vaccine.

Wyeth's decisions go a long way toward explaining why the United States — the world's richest market for medical products — finds itself with only half the amount of vaccine it needs to protect its population against a disease that may contribute to more than 50,000 deaths this year.

The company's exit is part of a long, slow industry-wide flight away from flu vaccine, which has simply become more trouble than it's worth.

"It shouldn't be surprising to anybody," said Gregory A. Poland, director of the vaccine research group at the Mayo Clinic, in Minnesota. "In fact, I marvel that there are companies willing to stay in the business."

Litigation against vaccine manufacturers (not over flu vaccine specificially, but vaccines in general, particularly those that used thimerosal as a preservative) did create some shortages prior to the mid-1980s, but the passage of the National Childhood Vaccine Injury Act of 1986 eliminated most of those lawsuits through the creation of the Vaccine Injury Compensation Program (VICP), a no-fault compensation alternative to suing vaccine manufacturers and providers for people injured or killed by vaccines. According to a 2003 report by the National Vaccine Advisory Committee (part of the U.S. Department of Health and Human Services), "vaccine shortages do not appear to be liability related":

The Vaccine Injury Compensation Program (VICP) enacted in the late 1980s has been of immense value in stabilizing the vaccine market. Prior to its enactment, litigation led to national shortages, withdrawal of manufacturers from the marketplace, and instability of supply of essential childhood vaccines. The VICP was designed to compensate individuals who suffered a serious adverse event as a result of administration of a covered vaccine in a manner that was rapid, simple, generous and appropriate. The VICP has assisted in stimulating the availability of new vaccines since its inception in 1988. Despite the success of the program, criticism of the VICP could lead to significant legislative changes, including a more relaxed burden of proof standard for determining eligibility for compensation. Today, litigation again threatens stability of the vaccine program in the form of class action law suits, exemplified by those that have been filed involving vaccines that contain thimerosal. The VICP is currently understaffed to meet the new increased numbers of claims. While current vaccine shortages do not appear to be liability related, the VICP should be maintained and strengthened as supported by scientific evidence, including continuing expansion of VICP to include additional vaccines as they are recommended for routine administration to children. The VICP coverage of vaccines should recognize that "vaccine" includes the active ingredient as well as preservatives, additives and other excipients. Strengthening the VICP would benefit manufacturers, providers and consumers and further safeguard the nation's vaccine supply.

Regarding the claim that John Edwards secured a $5 million judgment against a U.S. pharmacutical company on a flu vaccine case, while it is true he had a highly successful legal career representing individuals who had been badly harmed by malfunctioning products or the mistakes of doctors and hospitals, with some even saying he won $175 million for his clients over 12 years, at this point it's not known if he ever litigated a flu vaccine case, or if so, what the outcome of such a trial was.