Saturday, June 25, 2011

The cost of health care: Prevention and Indication “creep”, drugs, and the Sanders plan

The cost of medical care is rising. Some of this is from actual new forms of treatment and new technologies that benefit the health of individual people, and sometimes of populations. Some of it is from the enormously inefficient (as well as inequitable) “non-system” of health care delivery and insurance that exists in this country. Some of it is from the aging of our populations, resulting in an increase in the group of people who have the most chronic diseases and thus the greatest health needs. In addition, those new treatments successfully keep people alive who would have died from their conditions in the past, allowing them to develop new and even more complex conditions. In the near future, some of the increased cost will be the result of the coverage, mandated by the Affordable Care Act (ACA, “health reform”) of 30 million additional people, with their attendant pent-up health needs. And, of course, much of it is from gross greed and enormous profits being taken from the “health care dollar” by some by providers (hospitals, nursing homes and physicians), but also – particularly -- by insurance companies and drug and device manufacturers.

I have addressed many of these issues in the past, and will continue to do so. A recent blog (Insurance company profits up and patient care down, May 17, 2011) addressed insurance company profit, others have looked at the burden created by the aging population and the newly insured (e.g., Primary Care, Medical School Debt, and US Health Needs: Analysis from the Graham Center, May 30, 2011 ). Other blog posts have looked at the health insurance system (I have been, I hope, very clear in my endorsement of a single-payer system as the best method for providing not only equitable health coverage, but the platform for cost saving and quality improvement). Today, I would like to look at two others, the explosion of new treatments and technologies and their overuse, and the cost of pharmaceuticals.

Increased attention is being paid to the overuse of many procedures for invalid indications or in people who are not likely to benefit from (and may be harmed by) them. Rita F. Redberg’s Op-Ed piece in the NY Times Squandering Medicare’s money”, May 25, 2011), discusses 5 procedures that fall into this category. These include screening tests --  colonoscopy on people over 75, Pap smears on women over 65, PSA screening for men over 75 (although note that I have often written that its indications are dubious in all men, e.g. October 27, 2009: PSA Screening: “One of Medicine's Great Success Stories"?). They also include several procedures for vertebral fractures, the use of cardiac stents rather than drugs in prevention of heart attack, and the implantation of cardiac defibrillators in patients who will not benefit (Redberg is a cardiologist). Medicare pays for all of these, and many of them, particularly the procedures, but also the screening tests (because of the procedures that are likely to follow positive screens) have significant risks. (See also “Sales Tactics on Implants Raise Doubts”, NY Times, May 31, 2011).

The same theme is addressed in a recent commentary in JAMA by Djulbegovic and Paul, “From efficacy to effectiveness in the face of uncertainty: indication creep and prevention creep.[1] Although brief, it contains some concepts that might require explanation for those unfamiliar with research and epidemiology. Initially, they address 3 types of research: “Therapeutic and prevention clinical research is typically performed to address questions of efficacy (“Can intervention work in the ideal study setting?”), effectiveness (“Does it work, generalized to real-world settings and applied to individual patients?”), and cost-effectiveness (“Is it worth it and should it be paid for?”)” [my bolding]. They go on to observe that most research, particularly that funded by drug and device makers (but also by the National Institutes of Health, NIH), is in the first category, efficacy, and that, while there have been increasing calls for more effectiveness research, this is unlikely to happen for most of the clinical decisions in treatment and prevention, primarily because such studies are difficult to do and costly.

The result is that clinicians have to make decisions about the use of these tests and therapies in the real world and in patients whose characteristics (such as age, other co-existing illnesses, other treatments that they have been on, etc.) are different from those of the group studied in the efficacy trials. Clinicians also may use them to treat conditions – known as “indications” -- other than those that were studied and for which the drugs were approved by the Food and Drug Administration (“indication creep”). If a drug is used for a condition (“indication”) for which it is not approved, it could be of benefit. However, it could also be of no benefit (but definite cost), and might even (not infrequently) cause harm. When screening tests are used in populations for whom they are not indicated, as those discussed by Dr. Redberg, as well as in the several blog posts about PSA and breast cancer screening (see March 15, 2011: Men’s Health? Women’s Health? Valid screening opportunities or “Hallmark Holidays”?, October 30, 2010: Breast cancer screening: conflicting evidence? what are the important questions for health?), we have “prevention creep”.

Doctors and other providers could, of course, choose to not use drugs indications or populations outside of those for which it was approved, and not use screening tests outside of the populations in whom it was studied. Djulbegovic and Paul, however, spend some time discussing why it is more likely that they will opt for screening a wider population than not, and why they will use drugs for treatment of conditions for which they were not approved (“off-label indications”). This last is particularly probable when other treatments have not worked, and someone (perhaps the drug company?) has suggested that the drug might work for this condition. This is because doctors are more likely to regret not doing something than doing something, despite the ancient injunction primum non nocere, “first, do no harm”. If the treatment doesn’t work, so be it; if it causes harm there may be regret, but it may be attributed to the underlying disease. If the treatment is not done, regret ensues because the physician thinks of what benefit might have occurred more than what harm may have befallen the patient. And, of course, while all recommendations to use drugs for “off-label” indications do not come from drug manufacturers, they obviously benefit financially from the wider use of the drug, and thus have little incentive to conduct or fund effectiveness, or certainly cost-effective, studies.

Which brings us to the cost of drugs. Anyone who is on drugs currently under patent (i.e., non-generic) knows their high cost. Generics are drugs which are the same as the original brand-name product but are usually much cheaper. We have heard about efforts to import drugs from Canada and other countries because they cost less. This was even suggested by members of Congress during discussion of the Medicare Part “D” drug benefit, which is bizarre since those drugs are often made in the US. They are sold in Canada at lower prices because of Canadian government regulation. In passing Part “D” such regulation of drug costs (using Medicare’s enormous purchasing power) was explicitly forbidden. (Who lobbied for that, do you think?) Drug companies say their costs are high because of research and development of new drugs. In fact most of their R&D costs are for “me-too” drugs – modifying a popular and big-selling drug made by another manufacturer, or their own drug that might be going off patent – so that they can get a patent. Then they spend far more than what they spend on R&D on marketing, to try to establish this new brand and get consumer loyalty. An example is when Prilosec®, omeprazole, went generic – and even over the counter, without prescription -- the manufacturer modified the formula slightly to be longer acting and began marketing “the purple pill”, Nexium®, no more effective.

A new proposal that would lower drug costs to US consumers by as much as 90% has been made by Senator Bernard Sanders (I, VT), as reported by Dean Baker in the HuffPost Business on June 11, 2011, Bernie Sanders Tries Some Clear Thinking on Prescription Drugs. Sen. Sanders essentially proposes that the government buy out all existing, and future, patents on prescription drugs, making them available at far lower cost. The cost of buying out the patents would be paid for by the enormous savings to Medicare on the cost of buying the drugs. These savings would be so great that, even after buying the patents, the government would save an enormous amount of money. It is a very good proposal, one that would be effective, and would compensate drug manufacturers as well as benefit the government and patients. Of course, the compensation would be less than the billions that big PharMa makes on selling these enormously highly-priced drugs, so they will certainly lobby – probably effectively – against it.

Our health remains hostage to the financial benefit of private corporations. Why should this surprise us, when all of our lives also are? The question is when are we, as health care providers and as citizens, going to decide that we will no longer allow their financial interest to stand in the way of quality and cost-effective health care.

1 Djulbegovic B, Paul A., From efficacy to effectiveness in the face of uncertainty: indication creep and prevention creep”, JAMA. 2011 May 18;305(19):2005-6..

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