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

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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.

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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..

Freedom abroad, health at home: experiments in preventive health care

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First, we must celebrate the victory of the people of Egypt in ousting the 30-year dictator Hosni Mubarak, and we revel in the democratic character of both this peaceful revolution and that in Tunisia last month. We hope that all of the dreams and aspirations of the masses of people involved are realized – freedom of speech, freedom for women and minorities, freedom from hunger. Thinking and reading about it brings tears of joy and admiration for these brave people. It is truly inspiring and encouraging to see this part of the world moving in the right direction. I feel that it may be wrong to have a post that dilutes this excitement with discussion of other topics, but take comfort in the fact that the papers, magazines, and blogosphere are talking about little else.
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Unfortunately, at the same time it is sobering to think about how much, in the US, we are moving in the wrong direction (see Bob Herbert, “When democracy weakens”, NY Times, Feb 12, 2011). Politicians elected, with money coming from the wealthiest corporations and individuals, on the platform of promising to create jobs, do nothing of the kind (see Robert Reich, “The recession isn’t over until the jobs come back”, Kansas City Star, Feb 12, 2011. At the federal level, to the extent Congress is doing anything, it is giving money away to the richest and taking away from poor and working people. State legislatures are also focused on eliminating support for poor people, as well as oppressing immigrants and banning gay marriage – or any rights for gay people (see Charles Blow, “Repeal, restrict, and repress”, NY Times, Feb 12, 2011). And, of course, on further restricting abortion rights. Indeed, there are those in Congress who wish to eliminate Title X funding for contraception. Given that contraception is the most effective way to decrease the abortion rate, this seems bizarre, but only if you are into “reality-based” policy making.

Where is the good news in our country? We all know that there are lots of good people out there, doing lots of good things. In health care, much of the positive news is people pitching in, volunteering to try to fill the holes left by a health care system that does not, despite the Affordable Care Act (ACA), provide care for much of our population. One example is the JayDoc Clinic, an operation entirely run by students from the University of Kansas School of Medicine, featured in the Feb 12 Kansas City Star (“Student run JayDoc clinic serves the uninsured”). Great work, and a great article, but one result is going to be more people who are in need hearing about it, and further overwhelming the clinic. The JayDoc, like so many “safety net” clinics, is a “finger in the dike”, struggling to survive in providing basic care while billions are spent on what Don Berwick, currently head of the Center for Medicare and Medicaid Services (CMS) and his colleague Brent James at the Institute for Healthcare Improvement (IHI) call “rescue care”.

Meeting the basic health care needs of the really-needy is not only right and compassionate, but is likely to cost less (in dollars and pain) if it prevents serious illness later. Since this does not seem to be a focus of government, which is busy cutting taxes on billionaires like David and Charles Koch and cutting access to contraception, some progressive and thoughtful parts of the private sector have been creating models across the country. Many of these are detailed by surgeon and writer Atul Gawande in his article “The hot spotters: can we lower medical costs by giving the neediest patients better care?” (New Yorker, Jan 24, 2011).

Gawande examines several cities where efforts have been made to identify the sickest, neediest, and highest-cost-users of health care, and intervene to try to reverse or ameliorate the causes. Some of them, like the lead story of the program in Camden, NJ, are the result of hard and extended volunteer work, by Dr. Jeffrey Brenner and friends. Others, such as in Atlantic City, result from partnerships between existing institutions (in this case, a hospital and a union). None are the result of wise governmental leadership investing in these programs to reap a benefit of greater health and lower cost. In Red, Blue, and Purple: The Math of Health Care Spending, Oct 20, 2009, I discussed the implications of the fact that most people use little health care, and a small percent use most of it. Managed care in the late 1990s failed in part because it put major hurdles in the way of receiving health care for the large proportion of the population whose health care use accounted for a small percent of health care spending in any case.

The programs described by Gawande do the opposite; they identify the actual people who account for most of the health costs in these communities and provide services and support to help those people. In Camden, for example, 1% of the population – 1000 people – accounted for 30% of its costs. 900 people in two buildings (a nursing home and a low-income housing project) accounted for more than 4000 hospital visits and $200,000,000 in health care bills over a 6 ½ year period. And, as Gawande points out, Camden is not unique. There is no money for this from the public sector or insurance industry because it is being spent (in addition to insurance company profit and administrative waste) on “rescue care” for people with conditions that advanced so far because they never received sufficient preventive and primary care.

Public funds are also not being spent (indeed, as noted above, they are being cut) to support the myriad other “determinants of health”, social, economic, cultural and linguistic that are necessary for them to take advantage of preventive and primary care, to have the capability (Capability: understanding why people may not adopt healthful behaviors, Sep 24, 2010) of improving their health. Planning to achieve reductions in health care costs by “solutions” such as increasing copayments and deductibles so that people have “more skin in the game” are based on belief but not on facts. Gawande cites the experiences of benefit manager Verisk Health, which showed that such obstacles caused people to use less of all kinds of care – including primary and preventive care – until they finally got so acutely ill that needed to come to an emergency room, get admitted, go into an intensive care unit, so that costs in fact went up. One man “…had badly worsening heart disease and diabetes, and medical bills over 2 years in excess of $80,000. The man, dealing with higher co-payments on a fixed income, had cut back to filling only half his medication prescriptions for his high cholesterol and diabetes. He made few doctor visits. He avoided the ER – until a heart attack necessitated emergency surgery and left him disabled with chronic heart failure. The higher co-payments had backfired…” This outcome has been known for a long time; the RAND health insurance experiment in the 1970s and published in the New England Journal of Medicine in 1983[1] (see also: Joseph P. Newhouse, "Free for all?: lessons from the RAND Health Insurance Experiment", RAND 1993) showed that the opposite strategy – elimination of co-payments and deductibles -- resulted in higher utilization of health care; of both that which might be seen as “unnecessary” (colds) and that which was clearly necessary. And it saved money.

The interventions that have had success in Camden and other places were not “one size fits all”. Different people had different issues that required different interventions. Some were about poverty, some were about substance abuse or mental illness, some were about cultural misunderstandings or about language, and on and on. Interventions required more from nurse case managers for some people, social workers for others, physicians and nurse practitioners for others, and “health coaches” or promotoras for others. A lot of the latter; people who were familiar with the needs of the high-utilizer patients, who spoke their language, lived in their communities, and were often willing to “talk like [my] mother” to them.

And it is not always successful. But it is successful enough, far more successful than just pouring dollars into rescue care, that it needs to move beyond the limits that volunteers and a few forward-thinking institutions are constrained by. It needs to recognize the critical nature of teams, of integrating preventive and primary health care with basic social (and sometimes legal) services, with meeting core needs for food, housing and transportation that are all too often not even considered by policy makers. Funding is key; depending on volunteers in such efforts as these, or the JayDoc student–run free clinic will never come close to being a solution.

About Dr. Brenner’s program in Camden, Dr. Gawande writes “It remains unclear how the program will make ends meet”. In fact, these sorts of programs need to become the mainstream of health care and service delivery, and need to become the priority of federal, state, and local government.

[1] Brook RH, et. Al., “Does Free Care Improve Adults' Health? — Results from a Randomized Controlled Trial”,N Engl J Med 1983; 309:1426-1434.
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Non-preventive Health Screenings: Common Sense Family Doctor

A good review of the (non-) value of many highly marketed screening tests (these are "sold" at health fairs) by Dr. Kenny Lin, the Common Sense Family Doctor.
http://commonsensemd.blogspot.com/2011/02/preventive-health-screenings-that-are.html#comment-form

Health is more than Medical Care

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Bob Herbert’s column in the New York Times, January 23, 2010, “They still don’t get it”, is one of many recent pieces that articulately criticize the administration for pursuing policies that benefit the wealthy and the elite, and ignore the absolutely justifiable anger of the majority of American people. That anger is being stoked and ridden by the Republicans, as it was by Obama in 2008, because they are out of power. There is no question that, if the Repubs were in power, they would be even worse, and cater even more to that elite (ref: see administration of GW Bush, 2001-09.) One of the issues that Herbert takes on is health reform: “While the nation was suffering through the worst economy since the Depression, the Democrats wasted a year squabbling like unruly toddlers over health insurance legislation.” Herbert is not opposed to health reform, but rather the outrageous way that this sausage has been made: “No one in his or her right mind could have believed that a workable, efficient, cost-effective system could come out of the monstrously ugly plan that finally emerged from the Senate after long months of shady alliances, disgraceful back-room deals, outlandish payoffs and abject capitulation to the insurance companies and giant pharmaceutical outfits. The public interest? Forget about it.”

With the election of the 41st Republican senator – under Senate rules, 41 votes constitutes a majority in terms of blocking legislation – we have heard many opinions on what should happen with health reform. The Republicans and the right-wing, who, despite their opportunist populism stand firmly in the grasp of “insurance companies and giant pharmaceutical outfits” are predictably calling health reform “dead” and reveling in the possibility that the system won’t change at all. This, of course, is a disaster; the folks who voted for Scott Brown in Massachusetts because they were convinced by demagogues that they would lose their current health benefits will continue to lose them anyway, not because of health reform legislation but because that’s where it was headed – higher cost, lower benefits. Some progressives, including Paul Krugman (“Do the right thing”, January 22, 2010), and physician-writer Atul Gawande (in his Democracy Now! Interview with Amy Goodman on January 5, 2010), call for passage of the current plan because it will, in fact, benefit a lot of people. Krugman says the House should just pass Senate bill to avoid any further votes in the Senate, which might lose. There is a lot to be said for this position. Others, including those I respect most from Physicians for a National Health Program, call for scrapping this whole bill and passing a single-payer Medicare for All program, which is absolutely the right answer, but not going to happen. (Nonetheless, I will, and I urge everyone, to write their representatives every day demanding it!)

While I support single-payer health insurance as the necessary pre-condition for improving health care for the American people, it is also clear that the process of self-interest politics in the formation of the Senate and House bills (in which the self-interest of the most wealthy and powerful is the biggest influence) has moved the discussion so much to medical care insurance coverage and access that we lose sight of the ultimate goal, greater health. In an excellent “Perspective” in the New England Journal of Medicine, January 14, 2010, “Ranking 37th – measuring the performance of the US health care system”, Chistopher J.L. Murray and Julio Frenk review the 2000 World Health Organization rankings of health status in different countries in the world. They remind us that “It is hard to ignore that in 2006, the United States was number 1 in terms of health care spending per capita but ranked 39th for infant mortality, 43rd for adult female mortality, 42nd for adult male mortality, and 36th for life expectancy,” and that the probability of death for men 15-60 has dropped dramatically more slowly since 1974 in the US than in many other countries.

Murray and Frenk also remind us of “the vast number of preventable deaths associated with smoking (465,000 per year), hypertension (395,000), obesity (216,000), physical inactivity (191,000), high blood glucose levels (190,000), high levels of low-density lipoprotein cholesterol (113,000), and other dietary risk factors”. We may not see these numbers every day, but health professionals and policy people know (or should know) them. We have certainly seen calls from many sectors, from this blog to the President, for a realignment of funding priorities from expensive procedures to prevention, from high-tech subspecialty care to primary care, from huge expenses at the end of life to strategies that will extend healthy life, and these numbers emphasize how important those changes are.

But those changes only address health care, and more usually medical care. This can be a diversion, from other, maybe more important, policies that truly will promote health. Even if we can produce more primary care physicians (and other providers), even if we offer “pay-for-performance” type incentives for physicians to do “quality care”, even if we actually pay as much for spending an hour counseling and working with a person to stop smoking, change their diet, and exercise, as we do for a cardiac catheterization or colonoscopy, the problems listed by Murray and Frenk require behavioral change on the part of people. Doctors can help, by counseling, by prescribing drugs for the conditions (e.g., hypertension, diabetes) that may be drug-susceptible, but people themselves are going to have to be the ones who change their diets, exercise more, stop smoking, take those medications.

Please note that I am not one of those who wants to place the blame on individuals, and excuse physicians and other health professionals from their own responsibilities (“I told them to lose weight, to stop smoking, to exercise! They didn’t do it! They are not compliant!”). It is important, however, to look at these problems from a larger social perspective. In the paragraph above I purposely used the word “people”, not, as is popular, “individuals”. Because while individuals, if they are highly motivated enough (and this is helped by having higher income and education and social class) can change these behaviors -- and have, in many cases, such as the dramatic reduction in the prevalence of smoking, these are really societal issues. This sort of behavioral change is hard to do – stopping an addiction like nicotine is harder than heroin, but is nothing compared to changing your diet from foods that taste good (and yes, while to some degree poor food choices come from habit and culture, the fact is that sugar and fat taste good!) to those that are more healthful, to limiting intake of excess calories. And exercise is hard, not only when you are already fat, out of shape and a smoker, but when you are working 2 or 3 jobs, live in a neighborhood that is unsafe, and have to try to fit in taking care of your children.

Changing these health parameters is not going to happen solely from everyone having health insurance and access to medical care, paying physicians for “quality”, or increasing the number of primary care providers, or completely changing the premises of medical care reimbursement. It is going to require major societal change. Some has begun to happen – public smoking bans in many cities and states, calorie labels on fast foods in some cities, removal of high calorie snack and drink machines from some schools. But what it needs is not only for these actions to be universal, it will require much more. Stricter regulation of advertising of junk food to children, higher taxes on it, and less availability. The messages for eating healthful food need to be louder and more frequent than the messages to do the opposite. We have to ban insidious campaigns like “drink wisely” (i.e., "do drink"). And have strict limits on access to firearms. And we have to rebuild our communities to encourage not only purposeful exercise (“going to the gym”) but activity as a part of daily life: walking instead of driving to school, shopping, work.

Of course, for all of these changes, there will be powerful lobbies against it –even the easy ones (smoking bans, labeling) not to mention the generations it will take to significantly modify our built environment. And if you thought that the opposition to meaningful health care insurance reform was powerful, you ain’t seen nothing yet!
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