Guidelines focus on diseases, not on patients. I have long believed that the value of excellent generalists occurs when patients have multiple problems. Having one excellent physician who can balance the effects of multiple diseases and multiple medications outbalances any value from expertise in a single organ system.

My friend, Roy Poses, has a great rant on this issue based on a Sounding Board from NEJM – Pitfalls of Single-Disease Solutions

I love his first paragraph –

It has been fashionable for health care managers and health policy types to foist “single-disease solutions” on doctors. The best examples are single-disease management strategies, based on single-disease management guidelines. Such solutions may be attractive in their simplicity, especially to managers who may not understand that patients and health care are actually very complex.

If you have access to the NEJM, go read the Sounding Board. The authors nicely explore the issues involved in caring for complex patients. Both Roy’s rant and the Sounding Board raise serious questions about how we develop “report cards” for patient care.

I hope this issue gains traction, as it represents the key problem for generalists (having enough time to care for complex patients) and the most important opportunity for generalists (showing that we can indeed better balance the complex issues of patients with multiple diseases).

The answer

The question – how do we use data to make decisions about which drug to use. Doctors, Too, Ask: Is This Drug Right?

A growing number of health care organizations have in recent years taken rigorous steps to close one of medicine’s biggest information gaps. They are scrutinizing findings about all drugs, new and old, available to treat a particular health condition to determine which work best at the lowest cost.

Such evidence-based reviews, as they are known, are an effort to separate scientific wheat from chaff by examining not just the quantity, but also the quality of clinical trials and studies on a given drug. They also seek to determine how a drug’s risks and benefits stack up against competing treatments. These reviews have been applied to every major category of medication, from blood pressure treatment to antidepressants.

Practitioners like Dr. Brenner do not typically consult such reviews when deciding which drugs to prescribe, but instead rely on their own experience. But that may change as government agencies and academic centers disseminate drug review research more broadly.

The drive to base medical practice on such reviews is not new, but it is taking on more urgency as health care costs rise and many newer drugs prove to be only marginally better, if that, than older ones.

Dr. Eric L. Matteson, a rheumatologist with the Mayo Clinic, said such reviews also help to counterbalance the forces that influence doctors in writing prescriptions, like drug company pitches, medical specialists championing certain medicines and patients eager to get the latest drug advertised on television.

“The pressures to prescribe are enormous,” Dr. Matteson said. “You constantly have people at your door.”

One of the leading institutions doing drug class reviews is the Evidence-based Practice Center at Oregon Health and Science University in Portland. In recent years, some states have started to use reviews produced by the center to draw up lists for preferred drugs that their Medicaid programs will cover.

Today, about 12 states, including Washington, Oregon and Missouri, use the center’s reports to differing degrees.

Earlier this month, the federal government announced that it was planning to spend $15 million in coming years to pay for evidence-based reviews that will compare the effectiveness of various procedures and drugs used to treat 10 of the most common health conditions, including stroke, arthritis, pneumonia, diabetes and ulcers. The studies will be made available to doctors and the public as well as to government and private health plans.

That makes a lot of sense. This is an excellent use of our research resources. But Big Pharma disagrees –

Another recent study has suggested that an older pain reliever, naproxen, which is sold as Aleve, might also increase heart attacks, though several experts said the Aleve data was less troubling because the numbers appeared too small to be statistically significant. Drug companies say they support the idea of evidence-based medicine. But they also contend that the Oregon center’s approach is more about cutting costs than about science.

“What Oregon is doing is hiding a cost-cutting agenda that they are marketing widely under the rubric of evidence-based medicine,” said Dr. Mark Horn, the medical director for the government relations group at Pfizer. Dr. Mark Helfand, the director of the Oregon center, dismissed that suggestion.

I know Dr. Helfand – and he is beyond reproach.

I repeatedly call for better data concerning pharmaceuticals. We have researchers studying the data and publishing important studies. I hope that we will increase support for this vital research.

Donation

I made a donation today to the American Red Cross relief efforts – Go clickity click and help the victims

Medpundit talks about DCA

Crusading Cardiologist

Dr. Eric Topol of the Cleveland Clinic has come out against direct to consumer drug advertising – at least when it comes to arthritis drugs. He appears to make exceptions for cholesterol lowering drugs:

Rather than a sufficient waiting period after approval to firmly establish safety in the large, representative ‘real world’ population, the unbridled promotion exacerbated the public health problem. This is so poignantly clear for an indication such as arthritis, which is one of the most common conditions requiring medication. Furthermore, one has to question the wisdom of allowing direct-to-consumer advertising for lifestyle medications that have no capability of preserving life or preventing major events such as MI or stroke. Here the paradox of actually promoting these events is all the more difficult to accept. (emphasis mine)

Go read her entire post. I believe we agree on this issue.

Uncontrollable pain

F.D.A. Approves a Pain Reliever That Blocks Nerve Channels

“When you’ve taken all the kinds of pain medication that there is and you still have pain, that is a very frightening situation,” said Dr. Lars Ekman, president of research and development for Elan, which is based in Dublin. “When you have that kind of pain, there is nowhere to go.”

The drug is part of a new class known as N-type calcium channel blockers. It is known chemically as ziconotide.

The Food and Drug Administration approved the drug for patients who no longer receive relief from morphine and have moved to the next level of treatment, which involves a pump that delivers medicine directly to the area around the spine.

Prialt has been studied in patients with cancer, AIDS and other afflictions that produce chronic pain. More than 1,200 patients took part in three clinical trials.

There are side effects, and the F.D.A. said it would require its strongest warning to appear with the drug. Side effects may include dizziness, drowsiness and altered mental status, with patients confused at times.

This drug is approved for severe intractable pain. The side effects are clear and serious. This is the “court of last resort”. For that indication, its use may be compassionate.

Sometimes we cannot really talk about our jobs

Being a physician has challenges and benefits. I had this explicit discussion with my new intern and resident this morning (special holiday schedule team). When we walk into a patient’s room and introduce ourselves, the patient and family generally like and respect us. We start out receiving the benefit of doubt and only lose repect when we do something wrong. The public rates us highly. Our profession remains admired, even in these times. Patients will tell us anything. We learn more about human nature than most people ever want to know. This can cause some stress – A Young Doctor’s Hardest Lesson: Keep Your Mouth Shut

An unspoken but ever-present issue in the life of any doctor is an immodest, completely nonmedical concern: are doctors boring people? Sober and serious, surely. Respectable and educated, one hopes. A bit stuffy at times, perhaps. But dreary? As a profession, I think we do tend to run on the dry side, though till recently the reason had eluded me. Then, last month, my wife and I bumped into an acquaintance of hers while walking along the street. The person, unbeknownst to my wife, is a patient of mine, someone whom I treat for a chronic infection. After the patient and I shared a moment of mutual panic, we three chatted amicably and moved on. Except, that evening, my wife kept asking me why I was being so quiet and, well, boring. And I suddenly saw the problem: doctors are waterlogged with secrets, hundreds of them, thousands of them. Each day brings a new batch: patients’ admissions about drug use or sexual indiscretion, a hidden family, a long-held dream, an ancient heartache, undisclosed H.I.V. infection. Over the years, this begins to add up, the bulge expands, the joints get stiff. Yet the secret – the consequences of our ever-expanding repository of others’ secrets – remains, well, secretive. The situation simply is not addressed, not at the start, middle, or the end of a career.

While I am not certain that I agree with the author, he has certainly made me think. The culture of medical training leads to us having a very different view of people and illness. We do understand the consequences of indiscretion. We understand human frailty.

Other professions that traffic in secrets typically maintain silence for a fixed period: lawyers and spies, accountants and politicians, mobsters and four-star generals. Power or leverage is at stake, but once things settle, the gabfest can resume. But for us, the silence is forever. The consequence of this tight-lipped life is readily evident anywhere young doctors have congregated. Exploiting the single loophole in the code of silence – chatting up one another – they busily swap stories about patients. Near-maniacal peals of laughter are heard as the latest “I once saw this woman in the E.R. who” tale is recounted. The hilarity, the need to yelp, surely derives from something other than the quality of the story at hand. I know this because, um, I have transgressed a few times, to try out a story on someone not medical. And rather than hearing the appreciative party guy hoot of laughter, I receive only a confused squint. So we learn to keep quiet about the whole thing, trusted advisers in the persistent palace intrigue. But conducting business this way is confusing. What is off limits, and what remains in play? Can I say this or that? Pretty quickly, it becomes clear that the easiest and safest – though the quietest and dullest – approach is simply to shut up concerning just about everything.

To this day – almost 30 years since graduating from medical school – I have stories, really funny stories, that I can only tell to other physicians. Non-physicians do not see the humor and even find the stories gross or insensitive. As a 3rd year medical student, I wondered why we always talked about medical incidents when we got together. After a long work week, here we were swapping war stories. Several weeks ago I visited my medical school – where I also did my residency. I ran into one of my fellow interns (now the chief of pulmonary medicine). We quickly degenerated into remembering war stories about patients. I guess we live in a “secret society”. We must hold these stories confidential – except as stories to share with colleagues (omitting names and identifiers of course). But, it really is not a lonely life. It is a life full of the privilege of caring for others. But we often cannot talk about it or explain it. And maybe that is as it should be.

More on Reggie White

The preliminary autopsy support suggests that Reggie did die of respiratory failure. He apparently had two respiratory problems – sarcoidosis and sleep apnea. Sleep apnea may have contributed to death

White had the disease, known as sarcoidosis, for several years, family spokesman Keith Johnson said Sunday. He described it as a respiratory ailment that affected White’s sleep.

On its Web site, the American Lung Association describes sarcoidosis as a disease characterized by the presence of small areas of inflamed cells that can attack any organ of the body but is most frequently found in the lungs.

The cause of the disease, which is most common among blacks and white northern Europeans, is not known.

Sleep apnea causes people to stop breathing repeatedly — in some cases, hundreds of times — during their sleep.

Sarcoidosis is a well known granulomatous lung disease. Patients with sarcoidosis can have severe lung disease. It leads to a decrease in total lung capacity. That combined with sleep apnea probably led to decrease blood oxygen. This in turn probably lead to an arrythmia and sudden death.

This death is likely unavoidable. Perhaps the lung disease was much more severe than we knew. This death is unfortunate but it appears understandable.

Reggie White, RIP

Reggie White died last night. For the non-sports fans he was probably the greatest defensive end in the history of the NFL. He was 43. White dies Sunday morning

Through the family pastor, Sara White confirmed her husband’s death, saying that she believes White died of respiratory failure related to his sleep apnea. An autopsy is to be performed to determine the exact cause of death, which was not immediately known.

Long time readers know that I often use the death of athletes as a teaching device in medicine. I will refrain from commenting on the cause of the death until we have the autopsy results. As usual, we should examine Reggie’s death to see what medical lessons we might learn. More after the autopsy results become available.

Goldberg on Drug Importation

Cheap drugs from Canada (or elsewhere) sounds great. Drug importation is workable for the individual, but not a solution for our societal drug cost problem. Robert Goldberg makes this economic argument clear – Don’t Blame Canada

The fact is, there is only a limited amount of drugs that can be supplied at price-controlled levels worldwide. No degree of safety and surveillance can change the laws of supply and demand. Europeans and Canadians are able to get quality drugs at lower prices only because Americans pay free-market prices that fuel research and development.

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Canada’s reaction is not isolated. When Illinois tried to set up a program to have people buy drugs from Ireland, which has many drug-manufacturing plants, the Irish Pharmaceutical Healthcare Association called the Illinois program “totally unworkable and impractical.” It raised concerns about the effect of the proposal on the Irish prescription-drug supply. The association’s spokesman said that it “would cause enormous problems for us to meet our local obligations here.”

Again, just as in Canada, there is only enough of the most popular medicines in the European market to meet domestic demand at price-controlled levels and not one pill more. European leaders would not allow U.S. consumers to siphon off drugs and drive up prices any more than the Canadians would. Can anyone imagine Jacques Chirac allowing France — with some of the lowest prescription-drug prices on earth — becoming America’s drug store?

Importation proponents want us to believe that somehow the laws of supply and demand don’t apply to prescription drugs. Do they really believe that private companies can provide all the drugs we want, now and in the future, at half the price they do right now? That’s a market miracle I would like to see.

We can do much to lower individual’s drug costs. We can prescribe lower cost alternatives. We should examine drug lists regularly and work to decrease the total number of prescriptions.

Canada is not our solution. Programs like the Consumer Union’s review of less expensive alternatives are an excellent alternative – Consumer Reports Best Buy Drugs

WSJ on pain meds

The Painkiller Panic (registration required)

Of course, drugs also have huge benefits. And this page has long argued that in almost all cases the right people to weigh them against the risks are doctors and patients, not courts and regulators.

One of the most frustrating things about the latest news on painkillers is that almost none of the people reporting it understand the concept of relative risk–i.e., that a doubling of adverse events like heart attacks still doesn’t mean that event is very likely. A doubled risk might well be a chance worth taking, especially if the baseline risk is low to begin with and the drug’s benefits are significant for the patient in question. All of us implicitly accept this proposition with chemotherapy, for example, which poisons the entire body to kill a few cancer cells.

Why shouldn’t we look at painkillers the same way? If you suffered from disabling arthritis and understood that your baseline risk for heart attack or stroke over a given time period was less than 1%, you might be willing to accept a doubling to a mere 1.5%. That’s in fact what the study leading to the withdrawal of Vioxx in September found: 7.5 events per 1,000 in the placebo groups versus 15 per 1,000 among those taking the drug (and only after 18 months at a high dose).

Think patients don’t actually approach their treatment this way? Consider Dave Ellis, who was featured in a Journal news story on Tuesday. The 66-year-old Mr. Ellis, who has suffered for 30 years from degenerative arthritis in his spine, says he dreads the day two months from now when his supply of Vioxx runs out. “If I look at the numbers, I just don’t feel I’m at risk,” said Mr. Ellis, who has no family history of heart disease. Is Mr. Ellis an ignorant rube duped by drug industry advertising? No, he’s a retired pharmacist.

This article contains the most logical reasonable take on this subject that I have read. As we all know, drugs have side effects. We must allow physicians and informed patients to make decisions based on the probability of those side effects and their (the patient’s) willingness to accept the risks.