Good for People and the Health of the Country, or for Big Pharma’s Bottom Line?

Exactly how the swine flu story will play out remains to be seen, but there is one business sector that may secretly be hoping for the worst — vaccine manufacturers, that are more than $1 billion richer, a number that will soar far higher if, in fact, the winter outbreak is as bad as many fear.

Halo-worthy as vaccine makers may seem, the truth is that Big Pharma is motivated by more than a desire to save humankind, given the enormous profit potential from a successful vaccine. New blockbuster products and manufacturer-friendly legislation have combined to make the global vaccine market even larger and more lucrative than ever. In fact, the vaccine market is growing even faster than the market for regular pharmaceutical drugs, bringing in as much as $20 billion or more, by some estimates. That’s because the markup on vaccines is larger than on pharmaceutical drugs, making them especially profitable. However, as the use of vaccines has expanded exponentially in recent years, so have concerns regarding their safety and efficacy.

Vaccine Risks

Vaccines have enabled us to take major steps forward in public health, virtually eradicating devastating diseases, such as polio and smallpox, says Larry Sasich, PharmD, MPH, an assistant professor of pharmacy practice at the Lake Erie College of Osteopathic Medicine (LECOM) School of Pharmacy in Erie, Pennsylvania. But vaccines are drugs, he points out, and all drugs carry some risks. Though rare, vaccines have been known to cause seizures, brain damage and even death.

In the early 1980s, consumers deluged manufacturers with lawsuits, most especially parents whose children had suffered complications after inoculation with the problematic DTP vaccine (immunization against diphtheria, tetanus and pertussis, or whooping cough). Fearing the public health consequences if vaccine makers responded by reducing production or pulling out of the market altogether, the federal government passed the National Childhood Vaccine Injury Act of 1986 to shield manufacturers from liability.

Legislated Protection from Liability

The 1986 act created the National Vaccine Injury Compensation Program (VICP), which protected vaccine manufacturers from lawsuits and set compensation standards for people injured by their products. For example, compensation for vaccine-related deaths is limited to $250,000 — a fraction of what might be awarded by a jury in a civil trial if, say, a child had a fatal vaccine reaction. In truth, this amount of money is like pocket change to drug companies, and they aren’t even the ones who must pay up — the federal government writes the check. This protection may help get important vaccines to market faster, but it doesn’t do much to ensure safety, because vaccine manufacturers are shielded from consequences for products that turn out to be problematic or even dangerous.

Also, vaccines are genetically engineered and competitors are forbidden by law from duplicating them. This gives manufacturers a virtual monopoly on their products. Since they never have to face competition, biologic-based vaccines continue to generate big profits for years and years and years.

Gardasil: A Cautionary Tale

Protecting manufacturers this way puts consumers at risk. In 2006, for example, despite sparse data to support its safety and effectiveness, Merck introduced and aggressively marketed Gardasil, a new vaccine designed to protect girls and young women from cancer-causing strains of the human papillomavirus (HPV). Among their questionable marketing tactics, the firm gave hundreds of thousands of dollars in “grants” to medical associations to develop educational materials promoting the vaccine. Even worse, Merck made substantial campaign contributions to state legislators — as it lobbied them to make Gardasil mandatory for girls attending public schools.

Yet, this vaccine doesn’t vanquish a deadly disease such as polio or smallpox. Rather it protects against four viruses that comprise 70% of the HPV strains that cause cervical cancer — and even if they’ve received the vaccine, women still require regular screening for the disease. While study results published in the August 2009 issue of Journal of the American Medical Association (JAMA) note that Gardasil has a safety record in line with that of other vaccines, serious complications (including an increased risk for potentially fatal blood clots) have been reported. Gardasil is also painful and painfully expensive. The three-shot series costs $400 to $1,000, which is only sometimes covered by insurance, and last year brought in $1.4 billion in sales for Merck… amazing, given that there’s no evidence yet how long immunity will even last or whether booster shots will prove necessary. Thus far, the vaccine has been successful in preventing HPV infections that precede cervical cancer, but since this type of cancer takes years to develop, only time will tell whether Gardasil protects against cervical cancer itself.

Moving Forward: The Debate Continues

Even in the face of a pandemic, it remains impossible to reach a consensus regarding vaccines and whether they should be mandatory. Consumer advocates argue for greater regulation and higher standards (e.g., for new vaccines and other drugs, medical devices and procedures), while industry insists that government should keep its hands off. As for the vaccine shield protecting Big Pharma from liability, some legislators talk of getting rid of it while others say it should be strengthened.

Dr. Sasich told me that he personally believes that vaccines have the potential to do enormous good for society and that the vaccine shield enables science and technology to move forward faster and more efficiently. While I agree that many immunizations save lives, I am skeptical about some of the more recent entries into the vaccination arena, such as Gardasil. Perhaps manufacturers need a stick as well as a carrot — financial responsibility for failures as well as windfall profits for success — to motivate them to ensure that vaccines are safe, necessary and effective before introducing them on a large-scale basis to the American public, much less making them mandatory.

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