Dr. Paul Offit says what worked to keep vaccines on the market might serve as a model for ensuring that life-saving drugs continue to reach the shelves of America’s pharmacies.
Almost everyone connected to the medical field understands the dire need for tort reform. People sue healthcare providers for every reason imaginable: birth defects, drug side effects, surgical errors. In 1986, a woman successfully sued her doctor (to the tune of $986,000) for ordering a CT scan that caused her to “lose her psychic powers.” Some of these suits have merit. Others clearly don’t. But one fact is certain: the national lottery that our court system has become has created an upward spiral of rising health costs, soaring insurance premiums and “cover yourself” medical procedures – while discouraging future innovations that could save lives.
In the pharmaceutical realm, a litigation-happy public spells trouble for everyone, says Paul Offit, M.D., author of the new book The Cutter Incident: How America’s First Polio Vaccine Led to the Growing Vaccine Crisis. Fear of being sued into oblivion is already causing drug makers to shelve remedies like Bendectin (a morning sickness drug that was blamed for birth defects despite a lack of supporting evidence) and the Lyme vaccine (which was blamed for causing chronic arthritis, despite serious biological implausibility). And who knows what life-saving drugs will never be developed?
|Notes: Dr. Offit is a member of the American Academy of Pediatrics and he holds a Rotavirus patent, a potential conflict of interest. Conflicts of Interest in Vaccine Policy Making
“If the litigious element of our society continues to discourage pharmaceutical companies from taking risks, we will all miss out on drugs that could greatly improve or even save our lives,” says Offit. “Obviously, my book addresses vaccines in particular, but the same holds true for all sorts of critical drugs. It’s hardly surprising that pharmaceutical companies focus on highly profitable, relatively ‘safe’ drugs like those for treating obesity, high cholesterol, impotency, and hair loss.”
So, is the situation simply hopeless? Not at all, says Offit. He builds a compelling case for the creation of national “drug courts” staffed by full-time, specially trained judges and advised by court-paid neutral experts. These courts would be modeled on the vaccine liability program (touched on in The Cutter Incident) that already exists.
“Drug courts would solve a lot of problems,” says Offit. “They would take the randomness out of jury decisions, making it more likely that people who truly have been injured by a pharmaceutical product are compensated. They would make it harder for contrived or frivolous lawsuits to come to fruition. And their very existence would encourage drug companies to develop life-saving products that are currently too risky to consider.”
In The Cutter Incident, Offit lays out a solid background for his rationale. He examines a little-known biological disaster that occurred 50 years ago at the height of the polio epidemic. In the spring of 1955, Cutter Laboratories and four other companies made a polio vaccine by taking live poliovirus and inactivating it with formaldehyde. Because Cutter didn’t adequately kill the virus in their vaccine, 70,000 people became ill, 200 were permanently paralyzed, and 10 died. It was the worst biological incident in U.S. history.
As a result of this tragedy, a 1957 lawsuit set in motion events that still reverberate today. The jury found Cutter not negligent but financially liable for their product. “Liability without fault” was born – and ultimately, vaccines became the first medical product almost eliminated by lawsuits.
“In light of this story, it’s not surprising that only four companies today even make vaccines,” Offit points out. “And two of those four have severely reduced their vaccine research programs. Frankly, these companies have little financial incentive to continue producing vaccines at all – much less develop new ones to combat other deadly conditions. The liability threat is incredibly prohibitive.”
The only thing that has (so far, at least) saved vaccines from extinction is the National Vaccine Injury Compensation Program, created by Congress in 1986. Funded by a federal excise tax on every dose of vaccine, the program compensates people harmed by vaccines and protects pharmaceutical companies from abuses by personal injury lawyers. A panel of highly trained experts reviews cases to determine their legitimacy.
“In many ways, the vaccine compensation program was a model system to prevent abuses by personal injury lawyers,” Offit writes in The Cutter Incident. “Scientists, epidemiologists, virologists, microbiologists, clinicians, and statisticians reviewed scientific studies and recommended to the courts which problems were caused by vaccines and which coincidentally followed vaccines. If a child suffered a reaction caused by a vaccine, the program was designed to compensate the family for medical expenses and damages quickly, generously, and fairly.”
While Offit admits that the vaccine program is not perfect, he says it provides a good jumping-off point for the drug courts he and a growing number of medical and law experts envision.
“It is obvious that the system we have now is broken,” he says. “And no wonder. Cases involving prescription drugs are complex and confusing and involve a tapestry of factors that often aren’t even addressed. Juries can hardly be blamed for not understanding what many lifelong industry professionals can barely grasp. Specially trained judges and impartial medical experts can at least contribute to a more rational, controlled environment in which to have these cases heard.”
Lest this viewpoint sound elitist, Offit points out that early surveys done on the broader subject of health courts show that an overwhelming majority of Americans – on both sides of the partisan fence – support the idea.
“Most thinking people realize that the lawsuit industry is out of control, especially in the healthcare arena,” he says. “It really is hurting all of us – through higher healthcare costs, through vaccines shortages, through gaping holes in our nation’s medicine chest. We’re all suffering. We need a solution that will benefit drug companies, doctors, and patients alike. I believe the creation of drug courts is that solution. As more people become aware of this idea, I think they’ll agree. The future of our country’s healthcare system may depend on it.”
Paul Offit, M.D., is chief of the Division of Infectious Diseases and the Maurice R. Hilleman Professor of Vaccinology at the Children’s Hospital of Philadelphia. He is also professor of pediatrics at the University of Pennsylvania School of Medicine.
The book is to be published in hardcover, has 240 pages,, with 25 black and white illustrations by Yale University Press. It will be available in October 2005.
“The Cutter Incident: How America’s First Polio Vaccine Led to the Growing Vaccine Crisis” By Paul Offit, M.D. is available at Amazon