Monday, February 25, 2008

Patient Responsibility for Medical Outcomes

Universal health care in the U.S. would be a step in the right direction toward solving some of our many problems in the area of costs and delivery. One of the numerous pressures on costs are malpractice and negligence lawsuits. Physicians pay astronomical liability premiums. A significant portion of hospitals' budgets is spent on in-house legal departments. All health care providers and facilities are at risk in our litigation-happy society.

The ideal doctor-patient relationship is a partnership. Ultimately, both parties need to agree to participate in the care rendered. Patients should hold up their end of the bargain and refrain from suing their doctors at the drop of a syringe. Tort reform regarding medical practice would provide significant relief. For example, an ombudsman-like system of board review could be implemented. If a physician's actions were deemed to have met the standards of care in her specialty, a potential lawsuit against her could not go forward. Such a system could address both malpractice and negligence.

Cost savings would be enormous and would impact bottom lines across a broad spectrum of agents and agencies. Federal, state, and local resources would be freed-up from costly courtroom expenditures on wasteful medical litigations.

In a groundbreaking example of high-level support for such proposals, the U.S. Supreme Court ruled on 2-20-08 that "makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the FDA approved the device before it was marketed".

A case involving similar preemption for FDA-approved drugs will be heard by the Court in its next term.

This is a welcome trend, both economically and socially. The concept of personal responsibility has been battered and broken-down in the U.S. for many decades. "It's not my fault", people claim. "Twinkie's made me do it." Yes, a doctor prescribed a drug. Yes, a medical device was used. Yes, that drug or device had a manufacturer. But the patient agreed to treatment. Medicine is an art. There are frequent unexpected outcomes. Of course, we want to uphold best practices. Given best practices, lawsuits in medicine are inappropriate and need to be reined-in.

Manufacturers of defective products will still be liable. However, quality control is not a 100% guarantee. One malfunctioning device in an otherwise successfully deployed lot should not be grounds for a multimillion dollar lawsuit. Risks need to be shared. Full disclosure and informed consent are the tools to make these lawsuits go away.

Likewise for drugs. It seems obvious that the bottom line for global pharmaceutical companies is stock price and shareholder value rather than patient welfare. It may be that ultimately, in many cases, reliance on pharmaceuticals is misguided. In Global Pharmaceuticals: Ethics, Markets, Practices, Adriana Petryna and Arthur Kleinman describe the American "fetishization of pharmaceuticals" and the "pharmaceuticalization of certain disorders".

On 2-15-08 the FDA proposed new guidelines that "would allow drug and device makers to provide doctors with copies of medical journal articles" that discuss off-label product uses. The rules also say "drug companies do not have to promise to adequately test the unapproved use discussed in the article".

These proposed guidelines represent a radical sea change in policy. On the surface, they seem to pander to the desires of big pharma. This seems very problematic. On the other hand, FDA approval is not a guarantee of development of significant side-effects, as with the COX-2 inhibitors such as Vioxx.

The reality is that most drugs are not magic bullets. The playing field has shifted. Patients need to be protected, and that protection is best offered by regulation and information. But our regulatory system seems badly broken, and off-label usage may provide great benefit. Or it may not.

Medical risks need to be shared. Patients are not merely consumers. They are obligated to do their best to make informed choices. On the other hand, physicians need to clean-up their questionable relationships with drug manufacturers and drug representatives.

We want a health care system based on best practices, not based on most money.


Kelly Hills said...

Unfortunately, I'm only willing to concede it'd be a welcome trend if there was any possible way to have faith in the FDA's process. And as repeated stories just at this blog have shown, that faith is long since gone.

Maybe if the FDA were reformed, this would be a sensible and willing thing - but as is, it's just another way for large companies to hide behind the shield of an agency that has shown itself too willing to be bribed, too willing to overlook studies, too willing to fast track based on tenuous data.

MLO said...

The SCOTUS decision was nothing more than another brick in the road to fascism that has overtaken the USA. Shield corporations from their lying, thieving ways so that consumers have no recourse after they have bribed the officials.