Doctors' Lunch

A small group gathered for Thursday lunch, chatting about their concerns relating to "Health Reform," whether they anticipated difficulty in maintaining their incomes and whether they should be thinking about other career opportunities.  Questions were directed to the drug company representative who provided lunch about opportunities to work for the drug company he represented,  as experienced,  well-trained, competent doctors articulated serious thoughts about leaving practice.

The drug company representative talked about his product, a monoclonal antibody given by injection, for treatment of arthritis targeted, at this time, for patients who fail on other drugs, even those of the same class. A kidney doctor asked about use of the drug in his field because of the high levels of inflammatory substances which might be susceptible to its effects and a similar question was asked by a pulmonary doctor who mentioned that for certain severe lung diseases there were very few treatments available. The representative was asked about the cost of the drug,  eliciting a response of $1,000 - $2,000 a month, depending on dose. One doctor asked why many of the drugs of the general class seemed to be priced about the same and whether there was an agreement among the various manufacturers about target pricing.  The drug representative said that he wasn't aware of any such agreement and that this wasn't an area where he had any  information. Several of the doctors agreed that their patients who receive samples or low-cost initial ("come-on") supplies of this class of drugs can't afford to buy the drugs when their initial supplies are exhausted and leave their treatment programs. The analogy was made to illicit drug-dealers luring new customers for marijuana with low cost introductory deals.

Considering the high cost, and significant risk of serious side-effects, of the drug, the representative was asked whether there were any tests, such as genetic markers, which would predict which patient would benefit from the drug and which would not. He indicated that this was a subject of intense interest for his company, but there were no genetic tests available, to his knowledge.

If there were predictive genetic tests, they would probably reduce the number of prescriptions for the expensive monoclonal antibody since rheumatoid arthritis patients currently being considered for treatment  first receive a prescription and then are removed from the medicine if they do not respond (rather than never get it). It would pose an interesting dilemma for health insurance companies which can now say that they won't approve the expensive drug without evidence of effectiveness of specific therapeutic benefit, and if there were genetic markers indicating a high likelihood of success, would have difficulty maintaining that position.

Genetics, Population-Based Risk Studies & Public Access

Years ago, while performing 5-minute employment-related physical exams for a nursing home's employees, I violated the guidelines published in an insurance company's sponsored meta-analysis of the value of various physical examination steps. My mistake in examining the 35 mostly female workers was that I actually performed brief physical exams which uncovered a thyroid cancer in a 16 year-old (subsequently cured by surgery), an abdominal mass in a 16 year (a large teratoma subsequently successfully removed) and a cancerous breast lump in a 40-ish administrator.

According to the meta-analysis, I wasted my time checking the thyroid, abdomen, breast and other organs in these apparently healthy, uncomplaining, low-risk women.

Population based risk studies cannot predict the particular person who will have a thyroid cancer, teratoma or breast cancer. They predict that a certain percentage of the population will or will not get sick, not the names of those individuals. Risk-analysis studies should never be relied upon by a payer, physician or other provider as conclusively determining what needs to be done for each patient.

The 5 minutes I spent for each of the women described above yielded cures of serious diseases and saved the nursing home and its health insurers significant sums as patients were cured in an asymptomatic early stage of their diseases.

For the last 3 days, at my own expense, I have been in Houston, attending a genetic genealogy symposium held by Family Tree DNA (I have no financial interest in Family Tree DNA). Among the technical subjects, there was significant discussion of steps taken by various state governments, under the urging of "doyens of proper practice", against 2 companies which market "Direct to Consumer" genetic testing and provide information about population-based risks. Some of the experts have even leveled their artillery at genetic genealogy (which in my case, has restored a broken link to a family I would never have otherwise found).

Genetic genealogy is no threat to consumers. Participation is voluntary. If one does submit a specimen for analysis and is disappointed with the results (i.e., finding out that he is not related to Gates or Buffett, but might have several horse thieves in her family), it's not likely that the person will be at significant physical, mental or financial risk. Genetic genealogy links traditional genealogy research techniques to inferences about ancestral genetics. An enormous anthropological study, using similar techniques, is sponsored by The National Geographic Society and has been well supported by the American public. Rather than throw-up roadblocks to progress, government should provide standards which each laboratory performing genetic tests should meet and supervision by qualified inspectors to be certain that standards are met.

At the meeting, I heard reports of criticism of companies performing "screening" genetic tests to assess population-based risk of disease. Several of these companies employ genetic counselors (disclaimer: a member of my family works for one of the companies, but has not had any input into this blog) to provide sophisticated information to their clients. And at least one provides training for physicians interested in this area so they can develop expertise and provide medical advice and care to their patients.

The opposition to allowing individuals to spend their money to learn about population-based risk is puzzling. Dismissive statements such as "instead of spending money on genetic tests, they should stop smoking, reduce their alcohol intake, exercise and eat more vegetables" reflect arrogance. Political involvement in this issue may be more focused on raising political contributions, than in contributing to the knowledge, health and life enjoyment of Americans. Americans should have an unfettered right to purchase information and knowledge which may stimulate them to make changes in their lives affecting their health. And they should have the right to take their information to the physician of their choice to seek consultation and advice.

Since the Middle Ages, science and truth and knowledge dissemination have driven societal development and progress. When government prohibits access to information and advances in information technology, it is doing the nation no service. Let's stop the paternalistic nonsense of "our government will tell you what's good for you and what you need to know." If individuals want access to genetic risk-based information, they should be able to have it.

In these days of evidence-based medicine, rather than accept the criticism of the doyens, a study should determine whether the availability and understanding of genetic information about population risks changes people's behavior, reduces their risks and reduces the nation's cost of health care. Based on my participation as a fellow of the Health Research Council of the City of New York in the early 1960s (which is when dietary saturated fat intake dropped dramatically for the first time), I predict it will.

Energy Inflation and Health Care

What does energy cost inflation have to do with health care? As it turns out - a lot!

Health care is thoroughly enmeshed in the economy (consider - the cost of commodity supplies in the health care cost of living index has recently outstripped many other elements; malpractice insurers factor inflation into their premium structures because claims and settlements look forward for years; and hospitals and health care providers use large quantities of increasingly expensive energy). Not only will we have the usual increases in health care costs resulting from an aging population, increased requirements for innovative technology and treatment, intensivity of care, cartel-like market behavior, and other factors, inflation in energy costs will ultimately feed general inflation and have an additive impact on health care inflation.

Dollars spent for energy will not be available to employers or families to pay for increasing insurance or health care costs. Business closures or dislocations caused by inflating energy costs will mean that currently employed persons whose insurance is company sponsored, may lose their insurance or their ability to pay for insurance.

When the cost of energy is high, business and individuals seek dollar-cheaper energy sources. While the focus of the public is on low impact green energy sources (wind, water, solar), the big-money push is on to burn coal to replace or supplement petroleum-based energy sources. The coal industry has an extensive advertising program touting coal's low cost, plentiful resources, and ready availability. The advertisements do not discuss the track record of black lung disease in coal miners, black lungs in city dwellers exposed to coal smoke, nor the risks of acid rain, the release of strontium and other radioactive materials associated with the burning of coal, and the coal industry's troubling history of environmental degradation. The ads do not discuss the power-generating industry's sidestepping of clean air regulations through the use of grandfathering "add-ons" rather than the application of current standards to all current construction. Coal's immediate focus on dollar cost will seem like a bargain until we understand that the industry's cost-shifting will shift increased health care costs caused by diseases and environmental consequences of coal burning to the public.

There are alternatives. This is an incredible era of genetic exploration. The laboratory techniques which bring us a sophisticated understanding of the human genome could also be devoted to bringing genetic solutions to lower energy cost and availability. For instance, since nitrogen-fixing bacteria free legumes from the need for added commercial fertilizers, can we develop a gene-based nitrogen fixing technology which will substantially reduce the need for petroleum-based fertilizers on other crops? Can we use such a technology to produce biofuels, using marginal otherwise unfarmable land, while high-quality land, unencumbered by high doses of industrial grade petroleum fertilizers, is used to grow food essential for a healthy population. Can we move towards energy independence?

We have a choice: continue to destroy the environment, our health and our economy or use informed innovative science to help us deal with tough issues, such as energy and health.