The Administration closes the National Guideline Clearinghouse: Bad for our health!

The Department of Health and Human Services (HHS) has closed the National Guideline Clearinghouse (NGC), which was housed in its Agency for Health Research and Quality (AHRQ), by pulling its funding. If one goes to the NGC website, it actually says that there is no longer funding for it. The NGC provided a major resource for consensus information, and closing it is a tremendous loss, not only for the physicians and other medical providers who depended upon its recommendations, but for the health of the American people. It is also, sadly, a loss for the patients of physicians and other medical providers who did not heed, and even opposed the existence of these guidelines. This is because  they will now have the cover that comes from the absence of the NGC when they do things that are not supported by the best evidence available.

Wait, wouldn’t my doctor want to use the best evidence available? Can’t I depend on her/him doing this? Do I have to become a medical expert?

You – we would all – hope that our doctors would use the best evidence available. This is not necessarily the newest stuff, for the obvious reason that it is new, and thus less tested. Frequently, when a test or intervention is new, it looks good, but later, when more people have been exposed to it and more data are available, negative information may emerge. (Sometimes this is because serious side effects may appear to a new drug because so many more people are using it; sometimes it is the result of straight-up fraud, as in the case of Theranos – see The Political is Personal: Corporate power, social isolation, and the health of the nation -- Part 2, April 22, 2018.) Conversely, the oldest tests and treatments are not necessarily the best either – a doctor who does not keep up after his or her training is also going to be way behind.

And guidelines are, of course, guidelines, not laws – they are meant to guide the practitioner to help make the best decisions by summarizing and presenting the evidence, for the whole population and for significant “sub”-populations. For example, older people may have a greater benefit from – or be at greater risk of harm from – a certain treatment than younger people. This could be from a different physiology (kidneys, for example, don’t function as well at cleaning out poisons in older people) or from a different risk/benefit profile (perhaps a bad outcome usually takes longer to appear than the life expectancy of a person; a 20-year lag time for something bad has a different meaning for a 50 year old than an 80 year old).

Not all guidelines have the same strength of evidence behind them. Sometimes the evidence is very strong, coming from multiple randomized controlled trials (RCTs) that are consistent with each other; at the other extreme, they can come from the opinions of a group of experts in the field who are gathered for the purpose of creating a guideline. However, in any case, the guidelines presented should be those for which the strongest evidence exists. The website for NGC still has available the inclusion criteria for the guidelines that used to exist there. The physician is always able to do something different if the recommendation is for some (good) reason not appropriate for a particular patient. But s/he should know, or be able to find – on the NGC, say – what the guidelines are for a particular course of action (test, treatment, etc.). Until just recently, they could. Not now. Which raises the question: why is it gone?

I, of course, do not know the answer, so am forced to speculate. There is some cost to maintaining the guidelines and doing the research, and many people do not like cost, but so much more is being spent on arguably less important things (if one considers the health of the people important; I do). Some people, versions of libertarians, do not like anything that even suggests government mandates, but I know few libertarians who advocate suppressing the truth. Some people are not surprised at any actions taken by the current administration and its executive departments, particularly those that seem to take on science, as has happened with climate change and the use of fossil fuels, but those seem, ultimately, to be based on money and the opportunity for profit. Thus, destroying pristine areas for fossil fuel exploration (the Arctic, the tar sands) and transport (the Keystone pipeline), as well as of the world’s climate from burning them, makes people money. Rich and powerful people.

So maybe that is where we should look for the closure of NGC. The fact is that if there are guidelines there is a rebuttable presumption that, barring differences in the individual patient that are relevant, they should be followed. If the evidence shows that a particular diagnostic test or a treatment (drug, device, etc.) is usually better, it is going to hurt the pocketbooks of the manufacturers of alternative drugs or devices or tests. And it can also hurt the pocketbooks of actual doctors if they make their money doing something that is no more effective than, or even less effective than, doing something cheaper or easier – especially if that is done by someone else. Sometimes the issue is standardization; it saves money for a hospital (and can improve quality) if only one or two types of, say, artificial joints are used. But this hurts (obviously) the manufacturers of the other brands, and perhaps is a negative for those surgeons who have learned how to use the non-preferred brands (see Atul Gawande, “Big Med”, New Yorker, August 13, 2012). It is even a bigger issue when the evidence demonstrates that the costly surgical option doesn’t work, or doesn’t work as well as, a much cheaper non-surgical option that exists. Well, then, you are threatening someone’s income – just like renewable energy threatens the income of companies that produce and sell fossil fuels.

But would doctors actually do such a thing? Resist a cheaper and more effective alternative because it would cost them money? You betcha. Not always, of course, and not all doctors, but it has happened. “In the late 1990s,” the New York Times observes in its excellent editorial on the subject,  “when it [AHRQ] endorsed nonsurgical interventions for back pain, the back surgeon lobby waged an attack that resulted in huge funding cuts and placed a permanent target on the Agency for Healthcare Research and Quality (A.H.R.Q.), the agency that houses the database.”[1] They attacked the existence of the Agency because they didn’t like (REALLY didn’t like, since it would hit them in the pocketbook!) the evidence.

Yup. It happened. I remember it. It was shocking to me (I must have been more naïve!). I lived in San Antonio at the time, and a San Antonio congressman, Henry Bonilla, was leading the charge against AHRQ, to the embarrassment of the non-back-surgeon San Antonio medical community. But they were, and are, a rich and powerful lobby. And they are still doing thousands of surgical interventions for back pain of the type that AHRQ recommended against in the ‘90s. And making a lot of money on it. Maybe you had such a procedure? Did it help? I hope so. If you are trying to decide, for this or any other complicated treatment (surgery, cancer treatment, etc.) and wanted to know what was recommended for your problem, you could have gone to the NGC website and looked it up. Not now.

One issue with the evidence, of course, is that it depends upon what research was done, and on what populations. And diagnostic and treatment plans that make money for doctors and hospitals are only of use to them if they get paid, and paid well, so they are less likely to be done to poor and uninsured or underinsured people. Maybe this is one time when not having good insurance is a health benefit!

But it shouldn’t be. We should all be covered for necessary diagnosis and treatment. And whether providers or manufacturers can make money should not be a criterion for recommending it. And now we have less access to finding out what the recommendations are.

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[1]By the way, how did Fox News cover this story? I could only find one link, to Fox Vegas, which used the CNN coverage, which was quite critical of the elimination of NGC. National Fox didn’t seem to think it worth covering.

"Inconvenient truth", science, politics and USPSTF

There are a lot of things that we can expect to be different in a Trump administration, not only than in the Obama administration but even compared to that of G.W. Bush (my previous gold standard for irrational and right-wing policies). Many of these are important, and dangerous, but are arguably political, such as the change in our relationships with other countries (Russia, China, Europe, Israel). However disastrous these policies will be for people in the world (say, Syria) and even possibly destroy the world (nuclear weapons), they proceed from a different political perspective. Also arguably political will be the domestic changes, in the rights of LGBT citizens (such as marriage, use of restrooms), and access to reproductive health services for women, not only abortion but even contraception. The impact on people will be horrific, but it derives from a different perspective (admittedly one that completely devalues huge numbers of people; majorities in the case of women and non-wealthy people).

There will be other changes, however, that proceed from a rejection of science, or of what Al Gore calls “inconvenient truth”. Clearly the biggest one is the one that Mr. Gore was speaking of, global warming, because this will eventually destroy the planet. Maybe later, as we have already been so slow in implementing limits on warming. Maybe sooner, if his climate change deniers have their way. The title of Mr. Gore’s film has several meanings; it is “inconvenient” for all of us to try to find ways to use fossil fuels less rapaciously, but it is a financial issue for others. I am not talking about the coal miners who will lose their jobs; that is going to happen anyway. I am talking about the Captains of Industry, who, unlike the miners, will never be anywhere close to poor but have the possibility of making fewer billions if we seriously address global warming. Oh, the horror!

While of course the destruction of the environment is a health issue, there are also more prosaic health results from those who will try to make policies, or pass legislation, that benefits themselves or their friends and contributors at the expense of truth. Certainly we have seen this regarding reproductive health for years, especially at the state level, where laws restricting women’s access to abortion (targeted regulation of abortion providers, or TRAP, laws) have been based on what might be generously called phony science, or, more correctly, lies. These have included fetal pain syndrome, need for facilities appropriate for major surgery, need for admitting privileges for doctors doing abortions, excessive waiting periods,  and other made-up justifications for doing what legislators really wanted to do – restrict access to abortion. In Florida, a law was passed forbidding doctors from asking their patients if they had a gun in the home, meaning they couldn’t even have a discussion about how to keep them safe from their children accessing them.

So now we have the probability that Congress will be restructuring the membership of the US Preventive Services Task Force (USPSTF) to include more specialists on a body largely made up of primary care doctors and epidemiologists. The goal of the USPSTF is to dispassionately and objectively evaluate the evidence for the effectiveness of tests and procedures aimed at preventing disease. It gives ratings in easy to understand letters (A,B,C,D,I ) that are not based upon the opinions of the task force members but on the actual data. Unfortunately, this doesn’t always make providers happy; if you provide a service (say, mammography for breast cancer screening) on which you make money, then a recommendation that says it doesn’t need to be done quite so often hits you where it hurts – in the pocketbook. So you might come out against it. And while advocacy groups may not have the same direct financial interest (although if you are such an advocacy group, contributions are usually closely related to how serious how many people think a problem is), it may challenge your long-held beliefs. And then, if you find some doctors who agree with you (for example, those whose income may be decreased) you are more confident you were right.

But the goals of USPSTF recommendations is to synthesize the existing data and base their recommendations on that, not to reach “compromise” between those who want something done more (because they are “true believers” and/or have a financial stake in it) and those who believe it is unnecessary cost with little or no benefit and potential risk. This is why it is not necessary to include specialists on these panels because of their “expertise”. Other scientists can interpret the data accurately; a panel reviewing the data on, say, the frequency with which mammography should be performed in a particular population does not need mammography radiologists and breast surgeons to understand the research. This is not to say that such specialists are inherently biased and shouldn’t be on USPSTF; they could be as objectively good scientists as others. But it is to say that the reason being put forward for them being added to the panel – that they are ‘experts’ in the topic – is wrong. They should not bring their experiences and expertise to ‘balance’ the data. They should be guided by it.

It is not necessarily true that expert specialists are purposely obtuse, that they will advocate for recommendations that will make them more money. It is also true that their perspective is skewed by the populations that they see. Specialists see people with a disease, which is a selected population. Screening is, by definition, testing people who are asymptomatic and are statistically unlikely to have the disease. Therefore different standards are applied for screening asymptomatic people (say, all adult women between 50-75 by mammography) and for following up people previously diagnosed with breasts cancer, or those who are at higher risk (defined as a first-degree relative, mother or sister, with breast cancer, not a great-aunt). And, of course, doctors are not necessarily above advocating for laws to keep their incomes up. When, about 20 years ago, the federal Agency for Health Research and Quality (AHRQ) recommended against a specific type of spine surgery because it didn’t help, was risky, and cost a lot, groups of spine surgeons tried to get that agency defunded! Oh, yes, and AHRQ continues to be threatened with funding cuts because special interest groups don’t like their findings!  With the ACA requiring insurers pay for any USPSTF recommendation with an “A” or “B” rating, the political pressure is on to get such recommendations, whether the data supports them or not. On the positive side, the American Academy of Family Physicians (AAFP) has come out against such stacking of the USPSTF.

Once, when I lived in a good-sized condominium, I was one of the few families with children, and it seemed like they and their friends were often harassed for violation of (sometimes) condo rules and (more often) an individual’s belief of what should be a rule. Even the rules, however, were often, in my opinion, unreasonable; I thought the condo association rules should protect our investment and our safety, but should not be just anything 51% of the owners wanted. On the positive side, while they may have inconvenienced me and my family, they did not try to overrule natural law or science. The same cannot be said for current federal, state, and local efforts to make a law about anything they want to be true. They cannot make global warming disappear by a law, but they can make it illegal! And they can violate the rights and human dignity of our people. And stack federal agencies with anti-science people or at least turn what should be scientifically-driven decisions into a political negotiation.

This is going to be a long battle. Those with money and power are entitled and feel that it is their right to stack the deck. Happy New Year!

Greed, corruption and medical procedures: ignoring or suppressing the evidence?

One of the challenges for physicians who seek to advocate for patients by championing cost-effective, evidence-based medicine is opposition from the medical community itself. Physicians and other health care providers, as individuals, may practice evidence-free medicine, continuing to do things that have been shown not to work, to cost more than treatments that are equally effective, and sometimes to do harm. Sometimes this comes from ignorance of the evidence, because it may seem to be too hard to keep up. Sometimes it is because practitioners have “always” done it this way”, taught years or decades ago by their teachers. Or they may think that “their” patients are different from the ones who were studied; that “their” practice has shown them what works; that there is an “art” of medicine separate from the science. Maybe they are sometimes right, but usually they are wrong.

Yes, many important studies from which evidence-based guidelines are derived do not include all types of patients. For years poor and minority people were the main substrate for research (see “Tuskeegee”). More recently, perhaps in overcompensation, poor and minority people have been left out of research trials, which funders interested in health disparities (including the National Institutes of Health, NIH) are trying to change. But the fact that the patients you take care of were not included in these studies is not sufficient evidence for the results not applying to them. And, importantly, providers caring for exactly the population of patients who were studied are no less likely to ignore the results.

It is good to learn from your teachers. Hey, I’m a teacher. But new evidence emerges, and your patients count on you to be aware of it, to use it, to be on top of the knowledge that they cannot be. Does it take time? Sure. But that is the job. And for doctors that is one of the reasons that they are well-paid. To keep up. But what about one’s own personal experience? Experience is a good guide, in the absence of other evidence, but rarely does one provider have sufficient experience to have stronger evidence than large clinical trials. Moreover, “anecdotal” experience (“I once had a patient who X treatment didn’t work for”, or more likely “I once had a patient where Y treatment worked great”) has its own pitfalls. Mainly, it is usually wrong, even in the context of that individual provider’s practice. We have a tendency to remember the unusual, and to remember that for use in our future practice rather than the usual. I remember, while working in an urgent care center before the advent of “rapid step tests”, I had to  review yesterday’s throat culture results. I would see a positive result and say “Ha! I knew that patient had strep!”, but not consider all the negative tests on patients for whom I may have thought the same thing.  This is why we do large clinical trials. The “art” of medicine is important, especially in areas where there is no, or insufficient, evidence, and in translating that evidence into what the patient should do. The art of medicine is not, however, in ignoring the evidence.

Much more serious, however, is when greed causes physicians refuse to abide by the evidence because it shows that something that they are doing, which makes them money, is not indicated. This too can be subconscious, because if you have been doing a procedure for a long time believing it works, it is hard to suddenly change your mind because of new evidence. It is easy for your subconscious to deny that this resistance has anything to do with your own economic benefit, and is rather the result of your knowing it works. But when large groups of physicians, professional societies, get involved, it is no longer subconscious. It is financial protectionism pure and simple.

A good example of this is the recent opposition to recommendations by the Institute of Medicine (IOM) suggesting how the Food and Drug Administration should make rules governing the use of medical devices. Some manufacturers and physician groups  began to criticize them before they were even published (“Study of medical device rules is attacked, unseen”, Barry Meier, NY Times, July 28, 2011). The failure of many medical devices currently on the market, including artificial joints and defibrillators, was the impetus for this report. The IOM, a group of independent physicians and scholars convened by the National Academy of Sciences, are tasked with making recommendations on a wide variety of medical issues. Many of their most well-known reports focus on quality and patient safety, such as “To Err is Human: building a safer health system”. As Meier reports, a business group representing many of the device manufacturers went for the old “the best defense is a good offense” strategy and attacked the rules before they were promulgated. It is self-serving, but not surprising: “With millions of dollars of product sales at stake, the experts said, it is not surprising that the device industry and others would want to avert what they see as potentially restrictive new rules. Still, the lobbying has taken on a tone akin to Washington infighting over an issue like bank regulation, rather than patient health, they said.” Guess what? With millions of dollars at stake, it is exactly like attacking new bank regulations rather than focusing on patient health!  (For those who are interested, the actual IOM recommendations on medical devices, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years  is available on line.)

Of greater concern than these actions by the Washington Legal Foundation (additional information available in Wikipedia), a “pro-business group”, representing the self-interest of manufacturers, is the involvement of physicians. WLF’s attorney, Richard Samp, “… said his organization took action after the issue was brought to its attention by a lawyer who works at a firm that represents device makers. Shortly after filing its petition, the legal foundation was contacted by an official of the American Academy of Orthopaedic Surgeons, which represents doctors who perform joint replacements, who congratulated it for ‘taking the bull by the horns,’ Mr. Samp said.”

This is not the first time that orthopedics organizations (which for some reason choose to use the British-style diphthong “orthopaedics” despite being Americans who do not make a practice of using other medical diphthongs such as haemorrhage, oesophagus, anaemia or oedema) have chosen to attack evidence-based rules by political means. When, back in 1995, the Agency for Healthcare Policy and Research (now the Agency for Health Quality and Research, AHRQ) issued evidence based guidelines that recommended that certain popular (and remunerative) surgeries for back pain were not very effective, the orthopedic groups were able to convince Rep. Henry Bonilla (San Antonio) to introduce legislation to de-fund the agency! (“Agency’s report provokes a revolt”, by Neil A. Lewis, NY Times September 14, 1995).That’s playing hardball! However, the procedure, vertebroplasty, was overused, usually didn’t work and often caused harm. Interestingly, mounting evidence of its inutility continues to this day, recently for vertebral fracture in the British Medical Journal[1] [2], the results of which summarized by the editors of Journal Watch General Medicine.[3]

I don’t want to pick especially upon orthopedists (or orthopaedists), although as high-income procedural specialists, they have been involved in more than their share of these issues. Many of the IOM’s recommendations involve procedures done by other specialists, including cardiologists. Indeed, we need to applaud the work of the academic cardiologists who have done the studies that show that many of these procedures that constitute a major source of income for their practicing colleagues (the pâté and vichyssoise if not the bread and butter) are not indicated.

The researchers doing this work are some of the true heroes of medicine. Those who hold on to evidence-free procedures because they make a lot of money from them need to be careful that they do not join the villains.

 

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[1] Staples MP et al. Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: Meta-analysis. BMJ 2011 Jul 12; 343:d3952. Medline abstract (Free)

[2] Wilson DJ. Vertebroplasty for vertebral fracture: On the basis of current evidence, cannot be recommended as the first line treatment. BMJ 2011 Jul 12; 343:d3470

[3] “The results do not support routine use of vertebroplasty in patients with vertebral compression fractures, including those with recent-onset pain or severe pain at baseline. Strengths of this meta-analysis include its use of individual patient data and the blinding of patients to vertebroplasty or sham procedures. As noted by the authors, lack of blinding overestimates treatment benefit, which casts doubt on the results of a recent nonblinded randomized trial that suggested vertebroplasty is superior to conservative treatment (JW Gen Med Sep 2 2010).”

Comparative effectiveness research

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I’m a doctor, so maybe I have a different take on this than other people, but somehow I don’t think so. I would imagine most folks would want to know, before being put on a new, expensive medication (and in medications, “new” virtually always = “expensive”) a little more about it than that it worked better than nothing, or a placebo (which is not always the same thing, given the “placebo effect” – folks sometimes improve somewhat if they think a drug is going to work). I would imagine they’d want to know that it works better than, or as well as, or at least almost as well as, the drug that they are taking, or another drug, or especially a long-established, effective, we-know-how-well-it-works-and-the-side-effects-too, and frequently generic and cheaper, drug.

Studies that do this are called “comparative effectiveness research” (they can also be used for devices and other treatments). You would think, then, that there would be consensus that a new drug should be tested against existing drugs for the same condition and shown to be superior, or at least (in the scientific parlance) “non-inferior”. Not true; the FDA just requires studies that show it is better than placebo. This issue has been getting a lot of attention in the medical and scientific communities recently. A major contribution to this discussion was the recent study published by Michael Hochman and Danny McCormick in JAMA, March 10, 2010, “Characteristics of published comparative effectiveness studies of medications” (JAMA. 2010 Mar 10;303(10):951-8). This study looked at 328 previous studies evaluating medications and found that less than a third (104) had compared the drug against something other than placebo. Only 11 compared the drug against non-drug (“non-pharmacologic”) treatments; among the others only 45 compared two or more drugs, 32 with different pharmacologic “strategies”, and 16 different dosing schedules. Most of these, 90 of the 104, were financed by non-commercial sources (e.g., the government); the placebo studies were almost all funded by pharmaceutical manufacturers, who fund, it should be noted, more than half the medical research done in this country. This would be a good and noble thing, were it not actually a self-serving and thus often bad thing. Since many people cannot access the JAMA article (and might find it harder to understand it anyway), Hochman and McCormick also published an op-ed piece in the Los Angeles Times, “Medicine in the dark” which is clear and persuasive. In the same JAMA issue, two HHS physicians, Patrick Conway and Carolyn Clancy (who is head of the Agency for Healthcare Research and Quality, AHRQ, that supports much comparative effectiveness research), comment on the Hochman and McCormick article and call for increased comparative effectiveness research (“Charting a path from comparative effectiveness funding to improved patient-centered health care”, JAMA. 2010 Mar 10;303(10):985-6). They do not comment on the pharmaceutical industry funded studies.

Most practicing physicians are not active clinical researchers, and even those who are usually have a very limited research focus. Therefore, physicians need access to accurate and unbiased research, and need to spend the time keeping up with important new information that may impact your care. (By “important”, here I mean something that actually may benefit your health or that of another patient, not something that may benefit the bank accounts of the drug company shareholders – which I am sure is important to them.) Before beginning you on a new drug for your condition, especially when it is more expensive – often very much more expensive – and newer (please note that with drugs “newer” does not always – in fact, uncommonly, mean better. It does, however, virtually always mean “used and tested less so we are not necessarily aware of all adverse effects”, so you would hope that your doctor had reason to believe it was going to work better (or at least not worse) for you than your old treatment, and that this belief was based on independent reliable sources. That is, if not the original research, at least on independent reviews and summaries (like that of Hochman and McCormick, or The Medical Letter), and not simply information provided to them by drug salesmen. If you see lots of pens, pads, clocks, and other doodads with pharmaceutical company logos in your doctor’s office – not to mention if you get those neat “free samples” (which are never free; you and others buying the drug eventually pay for them) of the newest, most expensive drugs being pushed by the drug companies, you might begin to get suspicious. You might even ask your doctor how much time s/he spends with drug company reps and how much of his/her information comes from them, and has s/he ever audited his/her charts to actually find out (whatever s/he believes) if s/he is prescribing more of drugs pushed by drug reps? You might even complain. Doctors are sensitive to their patients’ complaints.

But what about when the doctor does look at the original research, but the research itself is largely funded by drug companies, who frequently suppress negative results? And if, as Hochman and McCormick point out, most of them just compare the new drug to placebo, not other established treatments? What value is there in that? Well, Peter Pitts, interviewed on NPR’s Morning Edition in their story on this issue on March 10, 2010, thinks there is value. He says doctors need to know what options are available. Of course, Mr. Pitts is a spokesman for the Center for Medicines in the Public Interest, a group whose name is absolutely contradictory to its function, since it functions in the interest of the pharmaceutical industry, which funds it. (And, really importantly, should never be confused with the absolutely wonderful Center for Science in the Public Interest, a truly great public interest organization that interprets research and advocates for food safety, the environment, and other issues that we need real scientists to help us to understand.)

As a physician, I agree with Mr. Pitts that we need to know what options are available. And, apparently unlike Mr. Pitts and the industry he represents, I think we need to know the whole story and how those options compare to one another, not a placebo. And I think you would want your doctor to know that also.
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