Thursday, October 20, 2011

Clinical Medicine, Capitalism and Creative Destruction

As the second world war ended, The Great Atlantic and Pacific Tea Company was opening supermarkets all over the country.  In time, local neighborhood grocery stores, bakeries and meat markets disappeared. When WalMart, Kmart and Target saw the opportunity, they began to compete for the family food dollar and eclipsed the A&P.  At the same time, small family farms were absorbed by large produce packaging companies.  They amassed huge tracts of land and adopted industrial scale methods of production.  Frank Perdue became a celebrity.

After that war, the automobile became a global product.  Newly established brands from Europe and Japan entered the American market.  Ford, General Motors and Chrysler survived and lesser marques like Nash, Hudson, Packard and Studebaker went the way of the corner grocer.  Lee Iacocca became a celebrity.

These are examples of the concept characterized as creative destruction.  It was inevitable that this model for change would come to the practice of medicine.  Over the last 20 years, the cottage industry of clinical medicine has been transformed into a collection of corporate behemoths.  In the process, Drs. Gupta, Chopra and Oz have become celebrities.

UnitedHealth Group Incorporated recently acquired the operations of a major physician's organization in California.  The purchase of the management arm of an association of approximately 2,300 physicians in a range of specialties established UnitedHealth's Optum Health Services platform as a formidable presence in the region.  Optum had previously taken over two smaller groups in southern California - AppleCare Medical Group and Memorial HealthCare.  This is the latest example of how lines are blurring between insurance companies and health care providers.

There is no way anyone could confuse the operating principles of such large corporate organizations with the insignia of the single practitioner or small groups of practicing physicians. The days are gone when a physician could move to a community, open an office, hire staff, and build a practice.  It is much too complicated today.  New legislation requires expensive technology, electronic medical records and structured human resources.  In order to deal with all the new rules and regulations, an affiliation with a large management organization is practically mandatory.  All over the country, individual physicians and groups are signing up with area hospitals, medical centers and academic teaching institutions.  As they recruit and buy practices, these large, multimillion dollar institutions with multibillion dollar budgets have made it possible for physicians to affiliate without having to move their office, change their staff or even change their telephone number.

These changes have not escaped the attention of doctors.  When I was in training, it was understood that a physician in practice had to deal with the demands of running a small business.  Although these issues were never mentioned in medical school or during house staff training, I knew there would be some relationship between my overhead costs and take home pay.  As more and more physicians realized that they weren't going to be just practicing medicine but would be part of a health care industry, they decided a Master of Business Administration degree was the appropriate credential.  By the late 1990s, there were a half dozen joint MD/MBA degree programs in the country.  Today, 65 institutions offer the combined degree program - with tuition and fees amounting to more than $250,000.  Not a trivial investment!  And, more significantly, not time spent acquiring or mastering skills sets relevant to caring for the sick!

Perhaps the most striking feature of the corporatizing of medicine is the widespread use of advertising campaigns by doctors and hospitals in newspapers, magazines and on television with the objective of increasing their market share.  It's not possible to estimate the total spent for advertising, however, it is clearly a significant addition to the cost of business.  Prestigious institutions such as New York Presbyterian, Johns Hopkins, Baylor, Cleveland Clinic and Cedars-Sinai have all launched costly promotions to extend their brand beyond the logical perimeter of their customary catchment area.  So Johns Hopkins Hospital is spending money to recruit patients to Baltimore from New York City - competing on New York Presbyterian Medical Center's turf.  It's said only one half of the dollars spent on advertising really works.  Since advertising is such a large part of the nation's health care budget, a great deal of money could be saved if we knew which half that is.

When entering the medical maze today, the odds of finding a solo medical practitioner or one in a small group are about the same as sighting a Packard on the interstate.

Thursday, October 6, 2011

What We Know And Don't Know

A story that recently appeared on the front pages of many newspapers involves the increased risk of breast cancer in women exposed to diethylstilbestrol - DES  while in utero.  This drug was widely used to prevent miscarriage in women who experienced vaginal bleeding  in pregnancy.  In the 1970s, twenty years after the widespread adoption of DES for the management of threatened spontaneous abortion, an unusual form of vaginal cancer began to be found in girls and young women.  Although it took some time to uncover the cause and effect relationship, it was shown that if a woman took DES between the 5th and 18th weeks of pregnancy her female offspring were at significant risk of developing the cancer.  Years later it became clear that there were also effects in males exposed to DES in utero - such as diminished sperm counts that compromised reproductive function.  More recently it was found that children of those exposed to DES in utero - the grandchildren of women who were given the drug during pregnancy - have abnormalities of the reproductive tract possibly as result of that exposure.  This suggests a potential epigenetic effect; a heritable change in the way genes behave without changing the genetic DNA itself.   In fact, 10 years after the adverse effects of DES were identified and several studies confirmed it was ineffective in preventing miscarriage it was still being prescribed for that indication.         
This complicated story might be considered of historical interest only were it not for the fact that more than forty years after the significant risks of DES were identified, we still have not established an effective early warning system to minimize such untoward events.   Dr. Steven Nissan, a prestigious cardiologist at the Cleveland Clinic, recently complained about the inability of the Food and Drug Administration to fullfill its mandate to sound the alarm about drugs with significant adverse reactions.  He said  "the agency is extraordinarily slow to act on safety issues and has compromised patients."

Most recently the drug pioglitazone, brand named Actos, used in the treatment of diabetes has been associated with an increased risk of bladder cancer.  The Food and Drug Administration has advised it should not be used in patients with a history of or active bladder cancer.  Furthermore, the advisory includes cautioning patients to report signs or symptoms of bladder cancer including blood in the urine, urinary urgency, pain on urination, back or abdominal pain.  All this is based on a 10 year study with an increased risk seen in patients with the longest exposure to the drug.  In France, similar findings were reported and sale of the drug was suspended.  In Germany, the official response was to advise that the drug be limited to patients currently using it.

There is no medicine that does not have adverse side effects, many are serious and some life threatening.  For example, as many as 1 million patients in the United States may be taking two medications each of which  taken alone have no effect on blood sugar but taken together can lead to increased blood glucose. This would present a major problem for anyone with diabetes.  This finding was uncovered by data mining the FDA's adverse reporting system, AERS
Clearly, patients should explore this resource to learn what is known about their medications and the potential interactions among them. 

One widespread factor that may affect the safety of any medication is environmental exposure to chemicals that have the potential for interactions, including increasing or decreasing the potency of a given drug dose or changing the rate at which the drug is metabolized.   Bisphenol A - BPA - a compound used to make plastic hard and clear is found in many products from eyeglass frames to plastic bottles and jars and the lining of beverage cans.  It has been shown to interfere with the function of the endocrine glands of animals.  There are reasonable questions about it's biochemical activity in humans.  As of today the answer is we just don't know.

The history of medicine is crowded with flawed notions held long after clear evidence not only questioned their validity but proved they were erroneous.  One might think this would have resulted in physicians being less certain about their practices and more humble in the positions they promote with such authority.  A reduction in physician hubris could result in patients being less intimidated. Absent that fundamental change in  physician behavior, patients must be alert to the risks associated with actions based on conclusions that may have been arrived at as a result of incomplete or inaccurate information; and the failure on the part of physicians to admit what we know, what we're unsure of and what we really don't know.