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Health Care for Men Isn't Simple Enough for Rules

Regulators just can't keep up.

By Will Offensicht  |  March 19, 2010

Deciding on the proper medical treatment for breast cancer and for giving birth is so complicated and so governed by individual differences that the government hasn't much chance of being able to specify reasonable rules no matter how much money it spends on "Comparative Effectiveness Research (CER)" as called for by the Obamacare bill.

It turns out that treating men isn't much simpler, as the pace of medical progress continues to outrun the government's ability to set rules.  The New York Times reports that the scientist who discovered a prostate-specific enzyme which has come to be known as PSA has declared PSA testing to be a medical disaster:

The test's popularity has led to a hugely expensive public health disaster. It's an issue I am painfully familiar with - I discovered P.S.A. in 1970. As Congress searches for ways to cut costs in our health care system, a significant savings could come from changing the way the antigen is used to screen for prostate cancer.

Americans spend an enormous amount testing for prostate cancer. The annual bill for P.S.A. screening is at least $3 billion, with much of it paid for by Medicare and the Veterans Administration.

Prostate cancer may get a lot of press, but consider the numbers: American men have a 16 percent lifetime chance of receiving a diagnosis of prostate cancer, but only a 3 percent chance of dying from it. That's because the majority of prostate cancers grow slowly. In other words, men lucky enough to reach old age are much more likely to die with prostate cancer than to die of it.  [emphasis added]

It's vital to understand his point that most prostate cancers grow slowly.  If a cancer is growing slowly enough that it's unlikely to kill you, your best course of action is to leave it alone.

If most prostate cancers are slow-growing, why test for them at all?  As with mammograms, testing is expensive and false positives lead to unnecessary treatment.  The PSA test requires analyzing a blood sample so patients aren't exposed to radiation as with mammograms, but the follow-up prostate biopsy process is far more dangerous, invasive, painful, and carries risks of infection as sampling needles are jammed through the rectum into the prostate.

The people who did the mammogram study tried to make the point that some breast cancers are slow-growing and some grow fast.  Treating slow-growing cancers may make the treatment statistics look good, but "saving" someone who wasn't going to die from cancer anyway is a waste of medical resources.

The same is true for prostate cancer:

Last year, The New England Journal of Medicine published results from the two largest studies of the screening procedure, one in Europe and one in the United States. The results from the American study show that over a period of 7 to 10 years, screening did not reduce the death rate in men 55 and over[emphasis added]

The test has its uses - a rapidly-changing level after cancer treatment can signal that cancer is coming back - but it's not a good indicator of cancer in the first place.  The test is still used, though, because advocacy groups continue to urge men to be screened and because drug companies make money selling materials for the tests.

Doctors fret that no matter what the guidelines say, they could be sued if they advise against a patient's getting tested and he later develops cancer.  It is difficult for real-world complexity to cope with simplistic regulations.

In "'Comparative Effectiveness' Research Is Always Behind the Curve," the Wall Street Journal asserted that cancer research is moving far faster than the slow-moving regulatory process can manage:

Cancers that present in a similar fashion clinically and appear identical under the microscope may vary significantly in how they actually express cancer-related genes. These genetic differences alter both the patient's prognosis and the doctor's choice of the most effective therapy.

Cancers which appear similar in many ways have different genetic characteristics.  Thus, the most effective treatment depends on the precise genetic nature of the defective cell whose uncontrolled growth formed the cancer.  The article points out that 192,000 cases of prostate cancer are diagnosed every year and 27,000 men die from it.

There are two issues to consider when treating cancer: a) How can the disease be controlled? and b) How does treatment affect quality of life?  A 50-year old man with an aggressive prostate cancer might want expensive robotic microsurgery to remove the prostate without damaging the nerves which control his sexual responses; an 80-year old man with a slow-growing cancer might be best off with no treatment at all because he's likely to die of other causes before the cancer would kill him.

The FDA's use of independently-monitored clinical trials is effective when large numbers of patients are to receive the same treatment, but are of no value at all for what cancer researchers call "personalized medicine."

If decisions based on CER inhibit the progress of personalized medicine - or in any way interfere with a meaningful interaction between doctor and patient to individually tailor the most appropriate therapy - no one is helped.

Technology is advancing to the point where your genetic makeup and the cancer's DNA can be analyzed to determine the best treatment for you, but custom medication is hard to validate using traditional statistical methods.

The CER research called for in Obamacare is the first step towards rationing health care.  Conducting research to identify the best treatment for each disease sounds good, but medicine is simply too complex for a set of government rules to apply to all cases.

Despite ample evidence that CER cannot be effectively applied to such common conditions as mammograms, giving birth, and prostate cancer, the Democrats are determined to forge ahead with it.  After all, it's the only way they can get the whole system under their control - and "control" is what it's all about.