Archive for the '*BLOG COMMENTS' Category

More stuff from the New York Times that misses the point

Sunday, June 13th, 2010

Michael D. Lockshin, MD

On June 10, 2010, Claire Cain Miller wrote that, “When a doctor recommends a test or a procedure, most patients simply go where the doctor tells them to go.”  

Well, not exactly, at least as I see it. It’s more like, When a doctor recommends a test or a procedure, most patients…ask their doctors who does the best test, then find out that their insurer won’t cover that facility or person, then find out that their doctors don’t know the providers of services that their insurer will cover, then find out that the people on the insurer’s list no longer accept the insurance, then do the test with someone no one knows and find that the doctor who recommended the test can’t understand the results submitted because the person who interpreted the test didn’t answer the question asked because his or her equipment was inadequate or he or she didn’t have sufficient experience with the problem to interpret it correctly.  

Right. Comparison shopping—by the insurers, with quality or communication not a priority. Big savings, eh? 

Before I sat down to fume over the first article, Nicholas Wade wrote, on June 12, 2010, that the genetic map, one decade on, has yielded few of its promised cures.  

I did not find this second article to be a surprise—it is evident to any practicing doctor—but my eyebrows did rise at the statement midway through the article: ‘“Genomics is a way to do science, not medicine,” said Harold Varmus, president of the Memorial Sloan-Kettering Cancer Center in New York, who in July will become the director of the National Cancer Institute.’  

Funny. I wrote about the distinction between science and medicine—citing a then-unnamed Harold Varmus—in my 1998 book, Guarded Prognosis (Hill and Wang), chapter 4, page 156 (actually, the whole chapter is about this topic).  

In 1996 Dr. Varmus was Director of the National Institutes of Health, and I was Acting Director of one of its Institutes, the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Dr. Varmus and I had argued about the budget for my Institute, and I, following that discussion, had gone home thinking about a patient of mine for whom contemporary science offered no answers and whose plight seemed to be a matter of indifference to the scientists.  

I wrote about that conversation: “Use only the criteria of other scientists, he seemed to say [to set your budget], while I was more willing to use my own judgment…developed over three decades as a practicing physician. We had different priorities, the scientist and the doctor.”  

Clearly, Dr. Varmus said the same thing to Nicholas Wade in 2010 that he said to me in 1996, except then he was trying to tell me that focus of the National Institutes of Health and of the National Institute of Arthritis and Musculoskeletal and Skin Diseases was medicine, not science, if, indeed, there is a distinction. Now he makes the distinction to explain why his priorities for NIH failed to achieve their goals.  

Sad. The United States has a National Science Foundation, which is for science, and which is distinct from the National Institutes of Health, for medicine. If I read the quote from Dr. Varmus correctly, he argues that NIH achieved its goal because it did good science, even though it failed to achieve a useful result for medicine?  

I guess we still have different priorities, the scientist and the doctor.

The New Medicine—Hospitalists and Telemedicine

Sunday, May 30th, 2010

Michael D. Lockshin, MD

So, two things in The New York Times set me off this week. (Actually three. The third was an article about people who start their sentences with the word “so”, but I don’t want to go there.)

The first thing that set me off was an article about a hospitalist (by Jane Gross, May 26, 2010). A hospitalist is a new breed of doctors who work full time taking care of hospitalized patients, a role we used to assign to interns. Hospitalists are the doctors of record for all in-patients. No longer is the primary or specialist physician who sends the patient for admission in charge. The hospitalist is. The hospitalist idea is not very new. For several decades the patient’s physician has ceded responsibility to the intensivist in the coronary care or intensive care or post operative care units, special circumstances that required a certain technological skill in care. Now this ceding of responsibility has grown; it now covers all hospital care.

There are two reasons for the change: one is to improve hospital efficiency (translation: prevent delays in discharge because tests were not done on time, not for the patient’s convenience but to avoid hospital days for which insurers will not pay); the other is to provide more classroom-type teaching time to interns and residents. This pedagogical goal is ordered by the accrediting commission for training; the apprenticeship model is no longer thought valid; the pedagogical goal has nothing to do with patient care.

The goals of having hospitalists are admirable, the practice less so. What one sees in this transition time, as doctors are adjusting to the new rules, is the insensitivity of some hospitalists to long-term goals for patients with chronic illness, an inpatient’s sense that no one physician, including his or her personal physician, is in control, and—from the patient’s point-of-view—a different set of inefficiencies.

An example: a patient I saw this week, at the end of a three-week hospitalization for a very confusing and severe complication of her chronic illness, still disabled and with visiting nurse service planned, was discharged by the hospitalist with instructions to follow up with…a dermatologist, urologist, gynecologist, hematologist, and rheumatologist. The point is that a single physician, whom she knew before, could handle all the concerns. There was no need to make five follow-up visits when one would do. Efficient, yes—to coordinate multispecialty care in the hospital—but not for the patient’s life outside, when the multiple issues had already been resolved. And, yes, while the rapid and multiple consultation process did save money in the hospital (because of its rapidity, but one can argue that most of the in-hospital consultations were unnecessary), the hospitalist’s discharge plan would waste both money and the patient’s energy if the whole package of outpatient and inpatient care is considered together.

So, on to point number two.

In an article in the May 30, 2010, Business Section, by Milt Freudenheim, a Dr. Oscar W. Boultinghouse, speaking of the marvels of telemedicine, says, “In today’s world, the physical exam plays less and less of a role. We live in the age of imaging.” That comment earns from me a disrespectful, “Hunh?” or an ironic “Right!” Tell the young lady now on our hospital floor, who has lost several fingers to blocked blood vessels, that physical examination plays little role. She had been seen by many physicians, all of whom wildly speculated about possible causes that had not been identified despite several inpatient days of extensive laboratory tests and imaging studies (see point one above). A quick examination by an experienced physician who actually took the time to look at and see the skin of her elbows, knees, and ankles, a physical examination that took less than five minutes, identified the cause.

What is the point? That physical examination (old-fashioned doctoring) still plays an important role. Also, you hospitalist and telemedicine advocates, a physical examination is cheaper and more efficient, too.

So?

The Butterfly Effect

Saturday, May 22nd, 2010

Michael D. Lockshin, MD

According to Sharon Begley and Mary Carmichael in their Newsweek cover story Desperately Seeking Cures, a cornucopia of cures for an infinity of diseases is (or would be) available but for (a) a culture that sets the wrong incentives for academic scientists and (b) a stodgy bureaucracy that does not prioritize urgent needs. 

Well, maybe…but posing the question that way misses important points. The article has a handful of examples, but ignores the fact that literally thousands of such examples exist. Scientists, venture capitalists, government, advocacy groups all have their own priorities, with no rational way but the marketplace to choose among them.

The article focuses on today’s Holy Grail, that a single aberrant molecule—a single target—if corrected or blocked, will reverse the course of an illness. Well, maybe that, too—if, as is unlikely, the illness results from a single gene mutation. But the chronic illnesses that I know, and possibly most cancers as well, have a better analogy: their origins are like the flap of the butterfly’s wings in Brazil that sets off a tornado in Texas. Human biology and human illnesses are so complex that it is unlikely that targeting a single molecule will “cure” any but the most narrowly-defined genetic diseases.

I am not nihilistic: I do believe that “cures” will be found. My argument is that the molecular-target-found: cure-imminent concept lacks humility. The butterfly wing concept is a better model of illness. If our goal were not to find molecular targets but rather to ameliorate those symptoms that we can recognize and measure, then we might take more pride in the progress we have made and we might direct our future research toward more attainable goals.

 

The Havasupai, Privacy and Medical Research

Wednesday, April 28th, 2010

Michael D. Lockshin, MD

I learned that the Havasupai of the Grand Canyon recently won a lawsuit against the University of Arizona. They claimed that the university had misused DNA samples that had been obtained from them for what they thought was research on diabetes. And, in fact, the researchers had studied the genetics of diabetes using samples from the Havasupai, but they had subsequently expanded their project to study the genetics of schizophrenia and ethnic origins of Native American tribes. In defense, the University investigators pointed out that the subjects of the study had signed consent forms that allowing use of the DNA samples for other studies. However, the consent form was very general. It did not speak to the possibility that the Havasupai people could be embarrassed by the findings or could have their myths of origin contested. The Havasupai people therefore sued the university claiming misuse of the samples, and they won.

I am sympathetic to concerns of the Havasupai, but I do not feel the question is as black and white as it sounds. True, in the United States, we give very high priority to privacy. The problem is with the definition of the word privacy. Our regulations, and our usual sense of the word, means individual, not group, privacy. The distinction is an ambiguity that needs to be clarified.

It is very common these days for medical research projects to bank DNA samples from individuals — genetic origin of disease is the hottest thing going in medical research right now. Investigators should do this work under very tight restrictions that require that "personal identifiers," such as birth dates, addresses, Social Security numbers, and any information that could allow someone outside the study to identify a specific individual blood donor, be kept under the strictest secrecy — locked cabinets, limited access, etc. The results of the study must be presented only in "de-identified" form, that is, no public information can lead back to a specific person.

Investigators have another requirement. If the National Institutes of Health or any other federal agency study funded the study, because tax dollars paid for the research, the investigators must provide de-identified samples to other legitimate researchers. The samples are considered public because they were paid for by public funds. The point is that the samples are very valuable, and cannot be obtained over and over again, so they should not be wasted.

In other words, the investigators who banked DNA for the Havasupai study of diabetes had to provide samples to a legitimate request of another investigator who thinks that the samples will be valuable for his or her research. Or, should other questions arise, the investigators are expected to use the samples already obtained and not go out and try to get new samples. By federal requirement, research projects that involve DNA banks have outside boards of experts to judge the legitimacy and the feasibility of a request and to decide whether or not it is legitimate to use the specimens for another study. The investigators can not make such a decision themselves. The point of the board is to protect the samples and to protect the dignity of the patients who gave the samples.

The researcher who asks for consent from the person donating the blood will usually not know the possible future uses of those samples, so the researcher uses a very general consent form that says something like "and for future studies as we may determine." The alternative is that the researcher can refuse to release samples until he or she goes back to the subject to obtain additional consents as each applications to use the DNA for other purposes arises. This is very cumbersome. Years elapse, people move or cannot be found. The feasibility of doing the second line of research thus becomes nil. This is not to say that researchers should be freed from onerous duties necessary to protect people's privacy, but rather to point out that the more restraints are placed on research, the less research will be done.

The Havasupai complaint introduces a larger question: the concept of individual privacy versus group privacy. The Havasupai were angered because they perceived group (not individual) stigmatization in the studies on schizophrenia. The privacy laws that researchers now operate under focus on individual privacy and do not think very deeply about group privacy. Nor do the federal regulations decide what might constitute an insult and what might not. Not everyone would consider a study on schizophrenia to stigmatize the group. Some people might be thrilled to learn their origins. Several years ago a study documenting that the Jewish priestly tribe (the Cohanim) could be identified through genetic tracking caused great excitement among the people involved.

I suggest that one cannot do genetic studies ("find the gene for a disease") without studying groups. If this suggestion is correct, any study of any gene could potentially stigmatize the group — it depends on what people may be embarrassed by. Should Greeks disallow studies on thalassemia (Mediterranean anemia), or blacks on sickle cell disease ? Or Jews on Tay-Sachs disease? How do you ask why Kenyans are great marathoners without identifying the group? What about the Long Islanders whose concerns led to the finding of the breast cancer gene — not, as they supposed, because of an environmental contaminant but because a group of ethnically related people lived nearby? Is one person's embarrassment another's clue to the origin of a problem? Whose rights prevail? Those who would be embarrassed? Or those who would benefit from the knowledge?

I do not know how to conflate the rules for individual and for group privacy. I don't think they are the same, and I don't know that prohibitions for the former apply to the latter. It seems to me that extreme restrictions on studies of groups, as we already have on studies of individuals, would inhibit research on the nature of disease, or on the nature of humankind. It seems to me that that privacy rules must be different for groups than for individuals. I suspect the distinction is not so clear and that discussions about where we should draw the line are due.

This conundrum is an opportunity for negotiation between researchers and subjects regarding about priorities. Personal privacy is a priority for some. Group privacy is a priority for others. Scientific advance is a priority for still others. These priorities conflict. There must be a negotiable position that distinguishes the rights of individuals from the rights of groups. Studies on schizophrenia, or on distant past origins of groups, are not intrinsically wrong.

Lowering Health Care Costs

Sunday, March 28th, 2010

Michael D. Lockshin, MD

On March 20, 2010, Lesley Alderman published an article in the New York Times quoting the responses of several doctors to the question, How can we lower health care costs. Their answers were very narrow:  insure catastrophic but not minor illness, change malpractice law, counsel nutrition, rely on evidence (don’t order tests you don’t need), allow for expertise, use “integrative medicine”, pay to treat childhood obesity, stop overeating, restore the humanity of medicine.

 

These are all good ideas, but I find them limited. The doctors mostly responded to issues in their own fields, and did not think of big ideas that can have large impact on costs.

 

Like Ms. Alderman and others, I do worry about the cost of health care. My solutions would be broader than those listed above.

 

The first solution would be to reduce waste: I see waste in the administrative cost of complying with (or arguing against) a multiplicity of insurers that have different rules and different forms, all dedicated to refusing care. The new health care bill will reduce but not eliminate this cost.  A one-payer system, or uniform rules for all patients, would be a tremendous help.

 

I see waste in the cost of pharmaceuticals, in the United States, that can be purchased at half the cost in Europe or Canada—why cannot we regulate pricing, or profit margins, the way that other countries do? I am willing to let drug developers recoup their development costs, but are we subsidizing Europe, or does our lack of price controls permit manufacturers to charge the most they can and profit more than they should?

 

I see waste in overuse of technologies—the repeated CT scans and MRIs, when a recent one will do. Granted, sometimes one machine, or one laboratory, does a better job than another, but mostly not, so this is a training issue: training both doctors and patients in rational use. It is also an abundance issue—if the machines are available, why not use them, the argument goes, particularly when, having been purchased, they must be paid for by maximum use?

 

I have other proposals that some may find unpalatable. Some patients do not accept answers doctors give, and seek other opinions. I do not argue with that right; it is fair and appropriate. Doctors differ in personalities, skills, and judgment, so bureaucratically locking one patient to one doctor is bad policy. On the other hand, this past week I was the fifth academic, professorial rank, highly trained rheumatologist to see a patient who had not heard the answer she wanted overall (I agreed with three of the prior four). It was easy for her to see so many doctors—who, by the way, each repeated all of her tests (I did not)—because her insurance covered all costs, no questions asked. Perhaps requiring her to pay upfront some part of the cost after, say, the third opinion, would reduce the over-doctoring that is waste. Or, as the physician in Ms. Alderman’s article who recommended covering only catastrophic care suggested, perhaps routine items of care, or minor medical problems, could be paid out-of-pocket, a low initial cost reducing the demand for what is (for some) totally free care.

 

The other unpopular solution that I offer concerns the inequity in physician pay. There is a 10-fold difference in income between primary care, non-procedure-oriented medical specialties and the surgical or procedure-based medical specialties. The difference is not based on achieved skill, hours worked, or even physician’s personal responsibility. (Surgeons often turn care before and after the operating room over to physician’s assistants or to their medical colleagues.) The pay scale is based on perceived value and drama of care—fair enough in a capitalist world—but one can argue for a narrower differential among specialties, for salaried rather than fee-for-service payment, and for federal support for training costs so that physicians do not enter practice deeply in debt (and so choose lucrative specialties to recoup).

Saving money is a test of values. Do you want insurance companies to set the rules regarding what tests you can or cannot have? Do you value capitalism so much that you concede price-setting to the companies that make the drugs you take? Do you want to have access to as many exotic technologies, and as many physicians, as you (not your doctor, not medical need) wish, as often as you wish? Do you want your doctor to be an entrepreneur in a fee-for-service system, earning what he or she can charge, or would you prefer that her or his diagnostic and treatment decisions be made without concern about the doctor earning less or more depending on the choice?

 

While I don’t find these questions hard to answer, I know that different answers are equally legitimate. The debate has just begun.

Health Care Reform Bill

Thursday, March 18th, 2010

Michael D. Lockshin, MD

A patient recently sent me the following question: As a doctor who has been working in the system even before Medicare Medicaid, are you for this final draft of the health care bill?

Here is part of my answer:
To answer your question, yes, I very strongly favor this bill — because I believe that once it is enacted it will progress to a much stronger bill, which I do not think can get passed at this time.

There is absolutely no question in my mind that Medicare and Medicaid made a huge difference in the lives of people who are generally not powerful and not very loud voiced. I actually wrote about some of the period of transition from before Medicare to after in my first book, Guarded Prognosis (now out of print.)

In case you didn't guess, I also have very strong feelings about Roe versus Wade (or about the availability of abortion). I also began my career before abortion was legal, have many (ugly) stories to tell, and I never want to see that time come again.

Expert Panels and Health Care Reform

Tuesday, October 20th, 2009

Michael D. Lockshin, MD

A friend recently send me a link to a Wall Street Journal opinion piece by Norman Gleicher titled 'Expert Panels' Won't Improve Health Care. Here is part of my response: 

a) insurance companies all have panels now, but they are secretive, inconsistent, and dedicated to protecting their companies from meeting their contractual obligations 

b) government panels are more likely to be open, challengeable, and uniform–not necessarily better 

c) Dr. Gleicher is right that 'evidence-based' has much less evidence than the public believes. That would be the source of the article in my head (and likely never to see print) that is entitled "the evidence against evidence-based medicine". This article would point out that individual choice and variability, among other things, trump the evidence, especially in chronic illness. The other point is that 'evidence-based' usually is judged on a 1-5 year outcome, and may come to a completely different conclusion if the gold standard is a 10 or 20 year outcome.

Michael Jackson, Deepak Chopra, Lupus, and Child Abuse

Monday, July 20th, 2009

Michael D. Lockshin, MD

A patient recently asked me about an article on People Magazine’s website about Deepak Chopra's belief that Michael Jackson had lupus and that this disease was connected to Jackson's childhood abuse.

Dr. Chopra cited ‘recent research’ in support of this contention.  

Here is some of what I wrote my patient: 

The article from the Mailman School is one of those associations that epidemiologists sometimes come up with that are not necessarily causal. What happens is that people with one medical problem virtually always have a higher frequency of a second medical problem, probably because (A.) they are much more in contact with doctors and (B.) they're much more aware of their bodies than are people who have not had to question their health. Epidemiologists (I was one once, thanks to Uncle Sam, but that's another story) are good for hypothesis generating but not for hypothesis testing. 

Other articles on this topic are more sensible. Quite a number of things about socioeconomic status have been investigated with regard to lupus. Although it is commoner in African-Americans, and African-Americans are on the whole poorer than Caucasians, there have been no bona fide associations between abuse and autoimmune illness that I know of.

Evidence-Based Medicine and Chronic Illness

Friday, July 3rd, 2009

Michael D. Lockshin, MD

It is a terrific idea to compare effectiveness of treatments for the same illness—if “effectiveness” and “same illness” mean the same to the doctors, the patients, and the payers and patients who will benefit or lose according to the rules that follow. It is a terrific idea if the comparison meets the needs of each participant and if effectiveness measured in the short term also predicts what happens after many years.

In chronic illness these ifs are mostly wrong.  For practical reasons, treatment studies mostly look at outcome after one or two years and at only one measure of success, such as, did a blood test improve? For chronically ill persons a short-term result many not predict the distant future. Some treatment choices require quick decisions: how best to repair a fracture after a fall. The immediate outcome may say the treatment worked (the fracture healed), but a later measure may give a different answer (walking is worse because the wrong repair was made). An illness relapses; the result—did permanent damage occur because the wrong treatment was used?—may take decades to know. A treatment effective in the short term (relief from pain) may be harmful later on (the chosen treatment weakens bones). The most important measure of effectiveness may be that disability does not occur, which we may not know for decades.

Treatments have side effects that some patients tolerate and others do not. Some patients choose one treatment that prevents crippling despite the fact that it increases risk of heart attacks, while another chooses a treatment that spares the heart but carries a high risk that the patient will end up in a wheel chair. Which is more effective? A third person cannot know the patient’s choice.

Effectiveness trials do not study complicated patients. Although a patient with rheumatoid arthritis who has had breast cancer cannot participate in an arthritis trial, this patient will still need treatment at some time. Patients with very mild disease and patients with severe disease are not part of trials but need to be treated as well. Exceptional patients—perhaps the majority of those with a given diagnosis—may not be able to take the “effective” drug, but, knowing the patient only by his diagnosis, the third party suggesting the most effective treatment may make the wrong call.

In a treatment trial, patients and researchers agree on the goals, relief of pain, for instance, or a joint less swollen. Outside the trial patients may have different goals. Methotrexate, the most effective first drug for rheumatoid arthritis patients, can deform or kill the baby of pregnant woman. Some women will not take it because they hope to or may accidentally become pregnant. Others will not take it for religious reasons. But even today insurers challenge the prescription of a less preferred drug while offering the physician no opportunity to explain deviation from their version of the effectiveness norm.

Personal goals can also trump the most-effective-treatment choice. To care for an ailing parent or child, to stay employed, to save a marriage, many patients will select short term gain over long-term risk. A few years ago, when Vioxx and Bextra were taken from the market, several of my patients ranked the relief provided by those drugs more important than risk of heart attack and hoarded as much of these drugs as they could find. Many patients so hate the way a drug makes them feel that they refuse a second course of treatment no matter how effective the drug is deemed.  “Effectiveness” seldom acknowledges to patients’ personal concerns.

Nonetheless, it is possible and right to compare effectiveness of medical treatments. In doing so, we should not use a one diagnosis, one time period, one outcome trial to decide the best treatment for complicated patients with chronic disease. We should instead compare treatments under real world conditions that include patients with second illnesses, with different severities of illness or different disease courses, and whose personal needs are respected when the treatment is chosen. The term “effective” should consider whether the effect is true for both the short- and for the long-term. Above all, labeling a treatment effective should weigh the patient’s opinion whether the treatment has or has not enhanced his life.

Medical Care and Doctor Fatigue

Thursday, July 2nd, 2009

Michael D. Lockshin, MD

Dr. Barron Lerner in the New York Times ("A life-changing case for doctors in training," March 3, 2009) misinterprets the history of Libby Zion and the Bell Commission, and draws the wrong lessons. The concern about medical resident fatigue dates not from the 1984 case but at least as far back as a 1971 study on the effects of sleep deprivation on electrocardiogram interpretation. Widely recognized concerns about physician fatigue led to a reduction from every other night call in the 1960s to every third then every fourth night in the 1970s and 80s. The tragedy of Ms. Zion’s death was the culmination, not the stimulus, of this trend.  
The important lessons of this death, not all of which have been addressed even today, are different concerns about how hospitals run:  Is it feasible for one physician to give adequate care simultaneously to patients "boarding" in multiple areas of the hospital, so placed because bed availability is sparse? How can physicians best care for hallucinating, intoxicated patients who resist care? How can one facilitate effective communication between supervising and supervised physicians? Are medical errors due to physician fatigue less or more severe than errors due to faulty handoffs? What system changes can one make to prevent these errors?