Sunday, February 26, 2006

The Paradoxes and Ambiguities of Pharma Research

One of the most morally ambiguous industries in the world -- particularly countries with capitalistic economies -- is health care. It is not morally ambiguous because health care is morally uncertain. It is morally ambiguous because delivering health services costs money; where costs and profits are involved, there is pressure for financial performance. Consequently, healthcare, which ideally ought to be an altruistic philanthropy, is instead a huge business that comprises appreciable chunks of a country's gross domestic product.

I'm not going to visit the tired debates associated with health care and businesses that manage health care services and payments. What I want to approach here is to discuss one or two of the ambiguities and paradoxes associated with the development of pharmaceuticals.

In Wired magazine, there is an article on the use of India's citizens as pharmaceutical guinea pigs (available for free March 1 on for foreign pharma companies to conduct clinical drug trials. This is a movement that has become increasingly appealing to pharmas because finding test patients in western countries is growing more difficult. Drug trials apparently involve three different test groups for a target drug: tests with healthy people, tests with slightly ill people and tests with people who have fully developed a particular disease. Each of these drug trials requires a pool of test patients. India has made its citizens voluntarily available for trials because a). they believe it can help bring in levels of health care that would ordinarily be unavailable to its citizens and b). India believes this sort of enterprise can enhance its economy much like outsourcing help desks and programming have done.

In my opinion, pharma is unevenly eviscerated in the liberal media as being unfeeling, profit-driven capitalistic endeavors. These people have not thought deeply about the paradoxes of money and health care. They have treated the economics and policy of capitalistic health care lightly and have glibly tossed out the "solution" of socialized medicine and buying pharmaceuticals from Canada. In their altruistic, idealistic and kind thinking, socialized medicine will give health care to everyone without realizing that all services cost something to deliver and consequently, someone has to pay for those services. When the someone is the government, socialists think that solves the problem of health care. It solves the problem of health care and introduces exorbitant tax rates on business and citizens, with a dire cost to our economy. Further, the notion of simply buying drugs from Canada fails to appreciate that should businesses, governments and citizens shift their purchases to Canada, pharma companies will no longer be able to subsidize the cost of selling drugs in Canada and will simply stop selling drugs to our northern neighbors. Then Canada will have to buy from us.

Costs will always be costs. Changing who pays the costs does nothing to change the costs. It only shifts the pockets the costs come from.

Over the past few months, I have found an increasing number of articles that describe what many people are calling the failure of the Food and Drug Administration to efficiently vet safe drugs. High visibility problems with drugs like Vioxx only reinforce the notion that the process of certifying a drug for introduction into the health care stream ought to do a better job of mediating the risk associated with the clinical trials as well as taking the drug itself once it is certified. Granted, the FDA faces a battery of ambiguities and paradoxes much like the pharma industry does: whereas pharma has to justify R&D investment in drugs that have promising marketability, the FDA needs to balance the needs of patients who are clamoring for life-saving drugs with the risks associated with testing and taking drugs.

Here is an interesting thought:

The FDA mitigates risk in clinical trials for people who have disease yet we do not apply the same rigor to preventing disease in the first place. The government mandates certain processes intended to minimize risk to trial patients and production patients but does not apply the same standards to the health of people to drive down the chances of contracting a particular disease in the first place.

In a sense, this is saying that the government is more concerned about the risk associated with taking a drug to cure a disease than it is in mitigating the risks of acquiring the disease in the first place.

One could argue that preventative health care is a statistical endeavor not a perfect science: people can only have a probabilistic sense of security from contracting disease. It is not certain that eating certain foods, engaging in certain activities and avoiding certain unhealthy practices will protect a person from contracting dangerous diseases. Similarly, many people who smoke never contract cancer, though they certainly experience other health issues.

Nevertheless, I find it odd that both the FDA and patients think little of actually contracting a disease but once a person has it, then there is a certain expectation associated with the risk of taking drugs to treat the disease. Initially, I was alarmed by India's decision to open its populace up to the risks of pharma research. But as I thought about the paradox of America's views on the risk of taking drugs versus the risk of contracting disease in the first place, I realized that India might well be on to something. The trials extend a higher level of health care to its citizens than they would have without the trials and India finds another economic niche in a global economy that quickly reduces niches to commodities.

We are somewhat insane in the way that we perceive our health care. Back in the mid-1990's, when Comrade Hillary attempted to foist socialized medicine on Americans by way of weepy stories of sick, poor people, the cartoon Bloom County featured a series of panels showing the Bill the Cat engaged in all sorts of dangerous activities. When his red wagon crashed into the ground after falling off a cliff, he muttered from the crumpled tatters of his body, "Free health care for everyone." This cartoon precisely captured the sentiment toward health care: that it was free if the government paid for it and that it was limitless in what it allowed us to do in terms of our lifestyle.

This article is not about a solution. It's about a couple of observations, namely:

  • Our sense of risk associated with taking drugs is the inverse of what it should be: we should have more concern about contracting disease than we do about the risk of taking a drug to treat the disease. Why are we more comfortable with the probabilities of contracting disease than we are with the probabilities of complications associated with taking drugs to treat disease?

  • Our notion of health care seems primarily prescriptive rather than preventative. We care more about responding to disease than in preventing it.

  • At first repulsive to me, I am inclined to think that India's approach to opening its citizenry to voluntary participation in clinical trials is an innovative approach to extend a semblance of health care that is greater than what would be present without the trials and which helps build India's economic infrastructure.