Talk time to listen

Common knowledge asserts that physicians often do not let patients tell their story prior to interruption. Many physicians apparently feel that patients will just talk forever, and that they (the physician) will not have time to ask their important questions. This research shows that we can let patients have their say. Length of patient’s monologue, rate of completion, and relation to other components of the clinical encounter: observational intervention study in primary care

Just go read the article – it is short and makes an important point.

More on cardiovascular effectiveness

For those who have access to Circulation – this perspective on the effectiveness article that I cited last week hits the mark – We Must Use the Knowledge That We Have to Treat Patients With Acute Coronary Syndromes I will quote a couple of relevant paragraphs.

Audit is an important component of quality improvement, but little is known about the effectiveness of quality improvement and audit programs. A recent pilot initiative by the Guidelines Applied in Practice (GAP) Committee of the American College of Cardiology,14 conducted in 10 acute-care hospitals in Michigan, tested strategies such as dissemination of guidelines, grand round presentations, and use of physician and nurse opinion leaders. Reassessment 3 to 11 months later showed that the usage of aspirin increased from 84% to 92% (P=0.002) in patients with acute MI, and the proportion of patients receiving counseling for smoking cessation increased from 53% to 65% (P=0.02) at discharge. The usage of ß-blockers and ACE inhibitors in “ideal” patients also increased (from 89% to 93% and from 80% to 86%, respectively), but these increases were not significant.

Some recent registries have documented relatively high usage rates of therapies. In the Global Registry of Acute Coronary Events (GRACE),15 92% of patients with ACS were prescribed aspirin at discharge, 77% were prescribed ß-blockers, 56% were prescribed ACE inhibitors, and 47% were prescribed statins. It should be noted, however, that the GRACE investigators were aware that their practice was being audited, and findings from previous audits were reported back to the investigators and compared with findings from other local and international centers.

National data sets from the United States1 show that aspirin usage in patients with coronary disease increased from 18% in 1990 to 38% in 2001, while ß-blocker usage increased from 19% to 40%, and ACE inhibitor use in patients with congestive heart failure increased from 24% to 39%. However, although the usage of these therapies has increased, it remains suboptimal, and the rate of increase in usage has slowed.1 At 1.4 years after an acute coronary event in the European Action on Secondary and Primary Prevention Through Intervention to Reduce Events (EUROASPIRE) study, 21% of patients smoked, 31% were obese, 58% had total cholesterol levels of 192 mg/dL (4.9 mmol/L), and >70% of diabetics had inadequate glucose control (fasting blood sugar 126 mg/dL [7.0 mmol/L]).16 Furthermore, too many patients were not taking aspirin (14%) or ß-blockers (37%).

=======================

Surprisingly little is known as to why doctors do not prescribe evidence-based therapies, but it has been shown that the factors most likely to encourage usage are dissemination of strong evidence, supportive opinion leaders, and integration of clinical practice within an organization that is committed to evidence-based practice.

Institution of the knowledge we already have could reduce mortality after an ACS by perhaps 80%. It is not sufficient to simply add 1 therapy at a time in patients at high risk of future ischemic events. Instead, whenever clinically possible, patients should be started simultaneously on as many as 4 evidence-based therapies while they are still in hospital, combined with nonpharmacological approaches to risk prevention such as smoking cessation, achievement of ideal weight, and graded exercise programs. There should also be insistence on long-term patient and physician commitment to these programs, with periodic testing of biomarkers and reassessment of the target variables for which the various therapies have been prescribed, in association with regular clinical examinations, stress testing, and selected imaging assessments.

Our research group spends much energy trying to understand the best ways to help physicians do this. While it does seem simple to non-phyisician observers, the problem really has great complexity. We can easily write about acute coronary syndrome care, but physicians care for patients with many problems. How can we help physicians keep up with knowledge and practice changes for all the problems that their patients have?

This commentary reemphasizes what our research group knows. Knowledge and efficacy studies are not enough. We must continue to study the problem of translating our knowledge into better practice.

Mort Kondracke on health care and the presidential campaign

Bush and Kerry, healthcare foes (warning – this link will give you the latest Kondracke column – thus if you are reading this in the future, you will have to search back through his columns to find this particular column).

If you or a loved one suffers from cancer, heart disease, diabetes or another dread disease — or you fear you might contract one — you have a hard choice when you vote for president this year.

President Bush is cutting the budget for medical research that might find a cure for your disease. At the same time, the Democratic frontrunner, Sen. John Kerry, D-Mass., wants to strangle the revenues of the pharmaceutical companies who’d develop a medicine to treat you.

Between the two of them, they’re a deadly duo. And Sen. John Edwards, D-N.C., would be little better. He’s joining in his party’s jihad against drug companies.

The remainder of the article argues that Bush is worse because of the proposed NIH budgets.

Disclaimer: I receive NIH funding and AHRQ funding.

Wow, this is a really tough issue. I am reminded of the famous George Bernard Shaw quote (often attributed to Winston Churchill) – “We’ve already established what you are, ma’am. Now we’re just haggling over the price.”. We know that we cannot increase the NIH budget by 100%. Our challenge is to understand how much we should increase that budget.

Supporting the NIH is akin to motherhood and apple pie. One can always stand on the high moral ground when criticizing the President’s NIH proposal. The question becomes not the NIH budget per se, but the NIH budget in the greater context of the overall budget.

I would love to see NIH increases and AHRQ increases. Our research group would have better funding odds. Our fellows would more likely have successful research careers. And even more important, our contributions (and the contributions of similar groups around the country) would improve our overall health status.

Read the article and perhaps you can decide (just on this issue) whose approach would benefit the common good. I fear that I cannot tell.

I often rant that each party has good and bad proposals related to health care. This article reinforces my beliefs.

Congress is wrong

2 Cancer Drugs, No Comparative Data – this title is misleading, because the drugs are really anemia drugs, used both with cancer patients and with Chronic Kidney Disease patients.

Medicare officials sought the study, hoping to see if Aranesp, a drug made by Amgen that costs about $1,300 a vial, is superior to Johnson & Johnson’s Procrit, an earlier version of the drug that costs $470 a vial. The federal Medicare program spends more than $1 billion a year on the two drugs, which stimulate the bone marrow to produce red blood cells in patients who have become anemic during treatment for kidney disease or cancer.

We (physicians) have no way to choose between two similar drugs (and these drugs are just variants of each other) unless we have head-to-head comparisons. I have repeatedly ranted on this subject. For physicians to control pharmaceutical costs, we must do the right studies. The study which CMS wants is the right study. Congress should not prevent important medical research.

I hope that we can overcome the pharmaceutical industries meddling so that we can do good comparative studies. Interestingly, the health insurance industry wants these studies. Thus, the Republicans have two major support groups at odds over this provision.

I hope that Congress revisits this issue. Perhaps this article and more like it will help everyone understand the importance of doing this type of research.

Democrats support trial lawyers on malpractic reform

Senate Democrats Block Caps for Malpractice

For the second time in less than a year, Senate Democrats on Tuesday blocked a White House-backed effort to impose strict caps on jury awards in medical malpractice cases. But Republicans vowed to bring the issue up again later in the year.

The backers of the measure, which would curb jury awards in medical liability cases against obstetricians and gynecologists, fell 12 votes short of the 60 necessary to have the bill considered by the Senate. The final vote, 48 to 45, fell mostly along party lines; the outcome was a foregone conclusion.

“We’re going to keep going until we succeed,” said Senator Elizabeth Dole, Republican of North Carolina, at a news conference before the vote. Senator Bill Frist of Tennessee, the majority leader, said after the vote, “I want to keep the issue out there, because I think patients are being hurt.”

You know how I feel about this issue. While caps will not solve the malpractice issue, they would help keep obstetricians practicing.

More on pharmaceutical influence

I found this link on theheart.org (which is heavily underwritten by pharmaceutical companies) – The Dawn of McScience. Just one quote to give you the sense of this long polemic.

Even scientific journals, supposedly the neutral arbiters of quality by virtue of their much-vaunted process of critical peer review, are owned by publishers and scientific societies that derive and demand huge earnings from advertising by drug companies and from the sale of commercially valuable content. The pressure on editors to adopt positions that favor these industries is yet another example of the bias that has infiltrated academic exchange. As editor of The Lancet I have attended medical conferences at which I have been urged to publish more favorable views of the pharmaceutical industry. For Krimsky, “the idea that public risk (that is, publicly supported research) should be turned into private wealth is a perversion of the capitalist ethic.” The Pope would probably agree.

Certainly this quote does not do justice to this long piece. If the subject interests you, I recommend reading and considering the problem of the pharmaceutical industry its influence on academe.

On existentialism

I have a hobby – I listen to books and courses as I drive. Currently I am listening to a college course on existentialism – No Excuses: Existentialism and the Meaning of Life . Several comments follow from this.

First, if you are interested in lifelong learning about various topics, you should explore the Teaching Company. Second, as I listen to this course, I am finding much in existentialism that reflects my own personal philosophy.

This interesting web page – Existentialism: A Primer – has this interesting quote as the author discusses existentialism.

Despite encompassing a staggering range of philosophical, religious, and political ideologies, the underlying concepts of existentialism are simple:

• Mankind has free will.
• Life is a series of choices, creating stress.
• Few decisions are without any negative consequences.
• Some things are irrational or absurd, without explanation.
• If one makes a decision, he or she must follow through.

Existentialism, broadly defined, is a set of philosophical systems concerned with free will, choice, and personal responsibility. Because we make choices based on our experiences, beliefs, and biases, those choices are unique to us — and made without an objective form of truth. There are no “universal” guidelines for most decisions, existentialists believe. Instead, even trusting science is often a “leap of faith.”

While this philosophy (at least this abridgement) does not describe the philosophical underpinnings of this blog completely, it does come close. I particular respond to the free will, choice and personal responsibility concept. Since I will be listening to these tapes for the next few weeks, you may see several more rants on existentialism. I believe that philosophy has great relevance to medicine and the politics of health care. Having strong philosophic underpinnings allows one to develop a more consistent decision making process. As I learn more about existentialism, I will try to share my thoughts on this subject.

On a light note, you might find this excerpt from one of Woody Allen’s early movies thought provoking (or even funny) – Existentialism

WOODY ALLEN: That’s quite a lovely Jackson Pollock, isn’t it?

GIRL IN MUSEUM: Yes it is.

WOODY ALLEN: What does it say to you?

GIRL IN MUSEUM: It restates the negativeness of the universe, the hideous lonely emptiness of existence, nothingness, the predicament of man forced to live in a barren, godless eternity, like a tiny flame flickering in an immense void, with nothing but waste, horror, and degradation, forming a useless bleak straightjacket in a black absurd cosmos.

WOODY ALLEN: What are you doing Saturday night?

GIRL IN MUSEUM: Committing suicide.

WOODY ALLEN: What about Friday night?

GIRL IN MUSEUM: [leaves silently]

“Play It Again, Sam”, Paramount Pictures, 1972

On pharmaceutical influence

For long time readers, this essay reflects issues that we have discussed several times. For new readers, read this NY Times piece, and then read my former rant on this topic.

When Your Doctor Goes to the Beach, You May Get Burned

Gifts

I will reiterate my position on pharmaceutical gifts. I accept anything that costs less than $10, e.g., lunch at noon conference, a pen (although I generally discard it after clinic), a pad of paper. I go to NO pharmaceutical company sponsored events – talks, golfing, consultations. I did some of these activities many years ago – then as I learned about influence, I understood that I was not immune from drug company manipulations. Thus, I had to distance myself.

From the NY Times piece:

Relatively few researchers have investigated the question of exactly what that something big is. Among other considerations, it is one of the few research topics in medicine that will not attract drug company financing.

A handful of studies have looked at the common practice of giving doctors free drug samples and have shown that it unquestionably induces them to prescribe drugs they would otherwise avoid. The other gifts also appear to bring a nice return. In one clever 1992 study published in the journal Chest, Cleveland researchers surreptitiously tracked doctors’ use of two drugs before and after all-expense paid educational jaunts to sunny resorts. They found that drug prescriptions more than tripled, an effect that persisted for more than a year, while the use of equivalent drugs remained stable.

It is all quite deplorable, my friend says. He used to add routinely that none of this data was applicable to him, but a recent series of events may have changed his mind.

For those who want to understand why drug company gifts work please read Cialdini’s work starting with this web site devoted to the psychology of influence – Influence at Work. If you are intrigued I highly recommend his book – Influence: The Science of Persuasion.

Medicare and quality

Many critics assert that we (the medical profession) should work harder on quality. This concept now carries great political weight. Here is what several critics say – The quality challenge: How best to raise the bar for medical care

Dr. Schoenbaum suggested establishing a new federal agency with the sole purpose of overseeing health care quality improvement. The same recommendation was made by a presidential advisory commission in 1988, but neither the Clinton nor Bush administrations have pursued it. That commission also recommended the creation of the National Quality Forum to promote the use of standardized quality measures and public reporting of results. The forum began collecting and endorsing those measures in 2000, but it relies on health care practitioners to voluntarily adopt their use.

NQF President and CEO Kenneth Kizer, MD, said there needs to be at least a point of focus within the federal government to help coordinate efforts. “If we’re going to see the improvements in patient safety and health care quality overall that have been so well defined by the Institute of Medicine in recent years, then the U.S. government has to play a central and an active role in that regard,” Dr. Kizer said.

The NQF could expand its role, if asked by the federal government, to include such activities as endorsing national quality improvement priorities, establishing a national medical error reporting system, and creating a uniform medical licensure process, he said.

But practicing physicians point out that measuring quality is much more complex than just examining a scorecard –

Doctors also remain skeptical about whether measures provide an accurate picture of their quality of care. Although large group practices might have the patient volume to accurately measure quality, small or solo practices often don’t see enough patients for a meaningful assessment.

“The scale of a physician’s office, combined with the variety of patients and procedures that are performed, make it virtually impossible to measure quality accurately and fairly in a physician office,” said Robert Reischauer, PhD, president of the Urban Institute, a Washington, D.C., think tank, and a member of the Medicare Payment Advisory Commission.

But that doesn’t mean Medicare and other public programs can’t begin to experiment with quality incentives for physicians, Dr. Reischauer said.

“I don’t think we have to wait in the sense that we can apply qualitative measures and reward those with high quality,” he said. “And those who choose to organize their practices as solo practitioners will just be out of that income stream.”

Measuring quality in physician offices remains beyond the government’s reach for now, said Tom Scully, former administrator for the Centers for Medicare & Medicaid Services.

“It’s just too complicated. You’ve got how many hundreds of thousands of physicians, and appropriately measuring them is years off,” he said. “My view is they all work in institutions, and what you’re really trying to do is not necessarily rate the individual physicians, you’re trying to drive change. If you can rate the institutions, it drives that.”

So we have tension. Should we measure and score quality? Should we ignore this movement because we believe it too philosophically difficulty to find good measures of quality?

I sit on the side of starting to measure quality – as long as the quality measures predict outcomes. One would have a difficult time arguing that the quality measures used in this study (that I ranted about last week) were unimportant – Proper care of Acute Coronary Syndrome – effectiveness data.

With this (and other studies) as landmarks, I believe that we can develop measurable quality indicators which lead to observably better outcomes. As long as we stick to that standard, then I favor the quality movement.

Costs and benefits

This article does not explicitly address medical issues. However, I believe it does a nice job emphasizing the costs of any benefit. One can take these principles and apply them to malpractice suits, drug benefits, marijuana laws, and many other issues that we address regularly. Goodies cost us

There are no two ways about it: There are benefits from all the costly federal, state and local regulations imposed on American businesses. But we must also acknowledge our federal, state and local regulatory agencies have no jurisdiction in India, China, Southeast Asia and Latin America. That means for many products and services, people who are far less productive than we, in a physical sense, can beat us in the global marketplace.

We all can agree there’s no benefit that’s worth any cost. If that weren’t true, we’d do nearly anything that has a benefit, and that would include mandating a 5-mile-per-hour speed limit. Why? The benefits would be enormous in terms of the tens of thousands of highway fatalities and injuries avoided. We don’t have a 5-mile-per-hour speed limit because we have decided its benefit is not worth the enormous cost.

No free lunch. Someone has to pay.

A sad story, a happy story, an important message

A Healthy Sense Of Urgency. (registration required)

This article should help everyone reevaluate their priorities.

My point on malpractice

Again I will use MQ’s words to stimulate a rant:

It was the role of the docs’ defense team to convince the jury (and I agree here) that not providing the CT scan was appropriate care.

The defense team failed. And you blame the plaintiff’s lawyer for effectively arguing his case.

If only people who feel that they’ve been the victims of medical errors would hire incompetent lawyers! That’s the solution to the malpractice.

So MQ, you agree that the physicians made the correct decision. Then you blame the defense lawyers.

This is my problem. Malpractice cases should not be a game between competing lawyer teams. My lawyer is better than your lawyer!

As original conceived, tort cases should arrive at truth. The goal of the law (not the practice unfortunately) is to provide justice.

I, and my physician readers, are interested in justice and equity. If I commit malpractice, the patient should receive a reasonable compensation.

Where we differ, and where I differ with the trial lawyer lobby, is in the venue for achieving justice. I shudder when I think of malpractice cases as a battle of wits between lawyers. They can become battlegrounds of sophistry, hyperbole, and obfuscation.

Trial lawyers who use these techniques can become rich, and even run for President. But I contend that the public suffers from this perversion of the tort philosophy.

We need a better method for judging claims. We need a method which looks at the data dispassionately, and seeks truth. We do not have that method in 2004.

On breast cancer and antibiotics

Several readers have written asking for my opinion on the antibiotic breast cancer link. Here is the Washington Post article about the study – Antibiotics May Raise Risk for Breast Cancer

The first-of-its-kind study of more than 10,000 women in Washington state concluded that those who used the most antibiotics had double the chances of developing breast cancer, that the association was consistent for all forms of antibiotics and that the risk went up with the number of prescriptions, a powerful indication that the link was real.

A variety of experts quickly cautioned, however, that the findings should not stop women from taking the often lifesaving drugs when needed to treat infections. There could be other explanations for the association, and much more research is needed before scientists understand what the surprising results mean, they said.

“This is not saying that women should stop taking antibiotics. Women should take antibiotics for infections,” said Stephen H. Taplin, a senior scientist at the National Cancer Institute who helped conduct the study. “We need to follow up and find out if this is a real association.”

Nevertheless, the consistency of the findings in a study with such careful methodology could indicate that antibiotic use is an important, previously unrecognized risk factor for breast cancer, experts said.

Antibiotics could increase the risk for breast cancer by, for example, affecting bacteria in the digestive system in ways that interfere with the way the body uses foods that protect against cancer, experts said. Another possibility is that antibiotics increase the risk by affecting the immune system.

Even if it turns out that antibiotics do not increase the risk for breast cancer, the finding is likely to be important because it could lead to the discovery of whatever it is about women who use the drugs that appears to make them prone to the disease, researchers said. “This has opened up a picture that people had not been thinking about,” Taplin said. “The important thing is more research and asking more questions about what it could be.”

My thoughts:

• This study reports an epidemiologic association. Associations are statistical findings which suggest, but do not prove linkage.
• We should classify this article are hypothesis generating. We now require more studies to examine this new hypothesis.
• The hypothesis may persist in follow up studies. If so, then we need further investigations to understand why there is an association.
• The positive side of this article is that it should remind everyone that antibiotics have clear indications. We should use them for bacterial infections and not use them for viral infections.
• This article should not change how we treat patients, but it may make women more receptive to not having an antibiotic prescription. It may decrease the demand for antibiotics for viral upper respiratory infections.

Overall, this article is interesting, but should not be over interpreted. We do not know that antibiotics cause breast cancer. We only know that one epidemiologic study found an association.

When defense lawyers try to make medical decisions

Each time I find another of these cases I become more astonished. Thanks to Overlawyered for finding them. Doctors on hook for $5M

On December 4, 1998, 11-month old Jack Sprague, while with his babysitter, suffered a subdural hematoma that has left him disabled. A Maryland jury just awarded $5 million against three doctors who saw Jack a couple of weeks earlier–the theory being that if they had performed a CT scan on the infant, the parents would have discovered the babysitter’s alleged abuse earlier, preventing the injury. …. Never mind that all three doctors diagnosed the asymptomatic infant as healthy: “What harm could it have done to do a CAT scan?” a juror asked. Well, even aside from the cost, and the risk of an anesthetic on an infant, doctors warn against unnecessary CAT scans to children because of the radiation exposure. How many healthy children will end up with cancer because of defensive medicine in response to this verdict?

Just another example of the problem of our tort system. This case makes no medical sense. The lawyer’s argument defies evidence based medicine (the cry that I keep getting as to the solution to the malpractice problem). I use this case to point out that many cases having nothing to do with evidence as physicians define evidence. Outrageous!!!

An interesting take on the pharmaceutical industry

No ranting – just a link – Pop That Pill This is how the article ends – the leadup is worthwhile also –

Is all of this bad? Not entirely. There is some notion of empowerment that goes along with being a medical consumer rather than a mere patient. Sure, drug companies are trying to persuade you, but that in itself means they are investing you with the power of decision-making. It means you are being emboldened to discuss alternatives with your doctor without being concerned that you will be patronized, as patients routinely were in the Marcus Welby era. But with empowerment comes increased responsibility. How many people have the insight or time to look at the published research before confronting their doctors with what they think is the drug they ought to be taking?

One doctor told me he’s gotten tired of arguing with those of his patients who insist on an inferior or inappropriate drug because they liked the advertisement. “I don’t make a case for or against individual treatments anymore,” he said, “no matter how much I may disagree, It takes away time I need to deal with other patients. I just flat out give my opinion, and they can take it or leave it. But considering that I’m the one with the M.D., if I were the patient, I’d listen up.”

Are there benefits to having a more informed patient base? “Informed is a loaded word,” this doctor said, “Informed about what? The ads usually end off by saying, ‘Ask your doctor,’ but the message they’re really conveying is, ‘Tell your doctor.'”

Whether to prescribe antibiotics for bronchitis

Antibiotic resistance represents a significant threat now, and in the future. Giving antibiotics for non-bacterial infections causes much of the problem. Physicians have a dilemma when patients have bronchitis. We just do not know whether whether we should prescribe antibiotics.

A new study suggests that we may be able to use a blood test to help with that decision. New test shows promise at reducing unnecessary antibiotic use

After the blood test results were revealed, the researchers then advised the doctors to prescribe antibiotics only if the blood level of the chemical marker, called procalcitonin, was above a certain level.

The rate of antibiotic prescriptions foreseen by the doctor was similar in both groups before the blood test results were disclosed.

But once test results were known, antibiotic prescriptions dropped almost in half. A total of 99 patients in the comparison group got antibiotics, compared with 55 in the blood test group.

Antibiotics were given to 22 patients with a blood test showing low levels of the chemical marker. Doctors often prescribe antibiotics to people with severe viral infections because viruses can damage the airways enough to encourage a subsequent life-threatening bacterial infection.

“Importantly, withholding antibiotic treatment was safe and did not compromise clinical and laboratory outcome,” said the study, led by Dr. Beat Muller at the University of Basel.

Dr. Marc Siegel, a professor of medicine at New York University School of Medicine, said the study convinced him the procalcitonin marker may help doctors, but larger studies are needed to determine if it is safe to withhold antibiotics from high-risk patients.

The danger of missing a severe or progressing bacterial infection is too great to rely solely on the blood test, Siegel said. “You worry about antibiotic resistance, but you also worry about patients dying,” he said.

Interesting! I hope we do see more studies on this test.

More data on the cardiac risk associated with the metabolic syndrome

Prognosis: Index for Heart Risk Shows Merit

Proper care of Acute Coronary Syndrome – effectiveness data

Many commentors (and this author) wave the flag of evidence based medicine to marshall arguments. Often we wave this flag without really understanding what the phrase means. We have 2 levels of evidence – efficacy and effectiveness.

Efficacy and effectiveness reflect the success of an intervention when implemented according to intervention guidelines under optimal conditions or in real-world situations, respectively.

– RE-AIM Framework: Efficacy/Effectiveness of Health Behavior Interventionsl

In that context, investigators performed an important effectiveness study on the importance of following guidelines in ACS which derive from efficacy studies. Combined Medical Therapy Improves Survival After Acute Coronary Syndromes. This study is very important because sometimes efficacy does not translate to effectiveness. In this study it does!

Use of all evidence-based therapeutic agents, when indicated, greatly reduces 6-month mortality in patients with acute coronary syndromes, according to a report in the February 17th rapid access issue of Circulation: Journal of the American Heart Association.

Several pharmacological agents have been shown to reduce mortality in patients with acute coronary syndromes, the authors explain, but the impact of their combined administration on clinical outcomes has not been studied previously.

Dr. Debabrata Mukherjee and colleagues from the University of Michigan in Ann Arbor examined the impact on 6-month survival of combined antiplatelet drugs, beta-blockers, ACE inhibitors, and lipid-lowering agents in 1358 consecutive patients with acute coronary syndromes.

Patients who received all indicated medications had only 10% of the mortality risk of patients who received none of the indicated medications, the investigators report.

The mortality risk was reduced by 83% among patients who used 3 of 4 medications indicated, by 82% among patients who used 1 of 2 medications indicated (or 2 of 3 or 4 indicated medications), and by 64% among patients who used 1 of the 3 or 4 medications indicated, the results show.

“Patients presenting with ACS represent an important high-risk cohort, where secondary vascular disease prevention is likely to be particularly effective and cost-effective,” Dr. Mukherjee told Reuters Health.

This is certainly an important study. As I have written previously, our research group is focusing on methods to help physicians adhere to well accepted guidelines. This article reinforces the importance of our research. When we see such dramatic effectiveness results, it emphasizes the importance of helping physicians follow rational guidelines.

Responding to a comment on Edwards and malpractice cases

“His tactics in winning cases using an unreliable tool in cerebral palsy cases demonstrate once more the triumph of junk science in the courtroom, and of how unreliable the jury system is in judging malpractice cases.”

If the defense (the medical community) couldn’t demonstrate that Edwards’ methods were “junk” (and the patients weren’t ahrmed), then the victim of the alleged malpractice deserved to win. Are you insinuating that juries are too stupid to make decisions in malpractice cases? What about murder cases?

With the current error rates in treatment decisions (~45% of the time) and with the needless death of tens of thousands of Amercans per year as a result of medical errors – and only a SMALL percentage of them ever seeing a court – the idea that docs are the helpless victims in this is myopic.

I just had to copy this comment – because it defines our problem exactly! Yes, I do believe that most juries are too unsophisticated to evaluate malpractice cases. These cases are often extremely technical, and require understanding scientific evidence.

Physicians are not receiving juries of their peers. The junk science which Edwards uses would not pass muster in any scientific medical journal. We (physicians) are taught to evaluate evidence carefully. Juries have no such training. Lawyers must disregard the scientific evidence in such cases, and replace it with emotional appeals and sophistry. That is exactly what distresses me.

I cannot speak about murder trials. My impression is that trial lawyers use evidence selectively in murder trials also (e.g., the jury ignoring the DNA evidence in the OJ trial).

When a physician’s career is on the line (and sometimes malpractice cases are that serious), then we need a higher standard of judging than our current system.

Most critics of physicians quote the flawed medical errors study. But even if that study were true (and I believe it greatly exaggerated), our current malpractice system does nothing to address errors. The randomness of awards and suits does not change practice for the better.

Rather we need a system that makes physicians accountable and provides fair compensation to patients. We do not need lawyers raking in a high percentage of malpractice settlements.

The commentor and I clearly have fundamental differences in how we view malpractice. I believe that a better system would reward more patients and challenge more physicians to fix our current system. The problem is that for us to really fix the current system we would need dramatic changes in reimbursement for medical care.

But then, these issues occupy a central theme of this blog almost daily. Daily readers know my positions. I am just so frustrated about the damage that malpractice attorneys do to health care that my fingers are obliged to type and type.

More on salt, water and potassium

Must I Have Another Glass of Water? Maybe Not, a New Report Says

We have previously discussed this issue, but this report does a nice job of putting the recommendations into perspective.

Washington Post on why we do not need drug price controls

Pricing Drugs

WITH THE MEDICARE prescription drug program projected to cost $134 billion more than originally planned, it’s hardly surprising that Congress is talking price controls. Rep. Nancy Pelosi (D-Calif.), the House minority leader, and Thomas A. Daschle (D-S.D.), her Senate counterpart, have already called for the government to negotiate prices on behalf of the private companies that will be buying drugs for Medicare recipients. Others have revived the idea of reimporting drugs from Canada. Pharmaceutical executives are braced for a price-control movement that may take off — and succeed — at any time.

Drug pricing remains an easy target for politicians. I agree that many drugs carry prices that I consider outrageous. When we prescribe drugs for patients in our clinics, I generally consider price as part of the decision making. Several examples are relevant here:

• I almost never allow Nexium, because other cheaper PPIs work just as well – at much lower cost
• We use captopril bid for hypertension rather than a more expensive ACE inhibitor
• We use ACE inhibitors rather than ARBs for price considerations

We are handicapped often by inadequate information. The Washington Post understands!

Finally, markets don’t work well without correct information. If Congress really cares about making sure drugs are used in the most effective and most economical ways possible, it should put more effort into ensuring that doctors and patients know enough about the drugs they are taking. Recent studies have shown that some older drugs may be just as effective as newer, more expensive drugs — drugs for high blood pressure, most famously, but also some antibiotics and antidepressants. Indeed, the vast majority of new and more expensive drugs — two-thirds, according to the FDA — use active ingredients already on the market. Yet there is no systematic testing to measure their comparative effectiveness. Although Congress, in the Medicare legislation, authorized $50 million for the tiny Agency for Healthcare Research and Quality to do exactly that, the figure has disappeared from the budget. Before Congress starts setting prices, more should be done to ensure that the public and medical professions have access to good information and that older and generic drugs are used whenever possible.

A great quote

This is a great quote. The reference is tangential – I was just reading a review of a book on greatness. But I love this quote, and will add it to my quote section.

One of Murray’s favorite ideas is contained in a quip he credits to his late colleague Richard J. Herrnstein: “It is easy to lie with statistics, but it’s a lot easier to lie without them.”

Is the new Medicare bill flawed?

Or how inconsistent our politicians are. This column documents the Democrats’ inconsistency on Medicare. I am not implying that the Republicans are any better when it comes to the political process. Patient welfare will always remain secondary to political gain. Medicare hypocrisy

What’s wrong with the new Medicare bill? Nothing that a little honesty couldn’t cure. A recent Wall Street Journal article suggests that the problem is not so much the substance but the failure of Republicans to rise up in defense of the measure. Since the day the bill was passed, Democrats, labor unions and seniors from retirement villages have been holding rallies and press conferences to scream about how the law is either “scamming” seniors or cheating them out of more generous private-sector coverage in order to pay off “Big Pharma and insurance companies.”

They are also annoyed that the drug benefit only pays for half of all drug costs and begins two years from now — not immediately. They want the pharmacy benefit management companies in the law to be replaced by Medicare price controls and a national drug list. Some disgruntled Republicans aren’t helping matters much by saying “I told you so” after learning that the Bush administration’s estimate of adding a drug benefit to Medicare exceeded the Congressional Budget Office (CBO) number by more than 25 percent.

To paraphrase Mark Twain, let’s get the facts straight and then distort them as we please. As an article in Health Affairs reports, the president “proposed an outpatient prescription drug benefit to be offered under a new voluntary Part D of Medicare … Medicare would pay half the cost of covered drugs ? The drug benefit would be administered by a [private] pharmacy benefit manager.” To help seniors maintain more generous private-sector coverage, “the president’s proposal had incentives for employers to keep [drug coverage]. Medicare would pay employers 67 percent of the premium subsidy costs it would have incurred if retirees had enrolled in Part D instead.”

Sound familiar? This proposal was supported by virtually every Democrat. But it wasn’t President Bush’s plan; it was Bill Clinton’s. And it had three big differences. First, it was scheduled to kick in four years after it was to pass in 1999, not in two as the Bush plan anticipates. Second, it covered a lot fewer people. And third, the Clinton plan didn’t cover catastrophic drug spending; it capped government spending at about $2,500 per senior with some adjustment for inflation. The Bush plan covers all drug costs over $3,000 a year.

I hope you read that excerpt and the remainder of the article. The Medicare bill is flawed. Virtually every bill passed by Congress is flawed. We can always find and exploit the flaws.

What we should (and apparently never will) do is to evaluate the pros and cons and weigh them to decide on whether a bill is worthwhile. I believe that on the whole (the forest view) this is a good bill. If I focus on trees, of course I see some that should be cut down.

Maybe this is funny to trial lawyers

Our neverending focus on narcotics

I rant so often about this topic. But it is important, and a great dilemma. U.S. Is Working to Make Painkillers Harder to Obtain

Top DEA officials confirm that the agency is eager to change the official listing of the narcotic hydrocodone — which was prescribed more than 100 million times last year — to the highly restricted Schedule II category of the Controlled Substances Act. A painkiller and cough suppressant sold as Lortab, Vicodin and 200 generic brands, hydrocodone combined with other medications has long been available under the less stringent rules of Schedule II

The DEA effort is part of a broad campaign to address the problem of prescription drug abuse, which the agency says is growing quickly around the nation. But the initiative has repeatedly pitted the agency against doctors, pharmacists and pain sufferers, and it is doing so again with the hydrocodone proposal.

Pain specialists and pharmacy representatives say that the new restrictions would be a burden on the millions of Americans who need the drug to treat serious pain from arthritis, AIDS, cancer and chronic injuries, and that many sufferers are likely to be prescribed other, less effective drugs as a result.

If the change is made, millions of patients, doctors and pharmacists will be affected, some substantially. Patients, for instance, would have to visit their doctors more often for hydrocodone prescriptions, because they could not be refilled; doctors could no longer phone in prescriptions; and pharmacists would have to fill out significantly more paperwork and keep the drugs in a safe. Improper prescribing would carry potentially greater penalties.

This issue has no easy solution. Patients will suffer under the new rules. Abusers will figure out ways to obtain drugs. Physicians will get caught in the middle. But you know the story.

The entire article is well done, and describes both sides of the issue. I particularly like this quote:

Susan Winkler of the American Pharmacists Association said her organization is concerned that the “ripple effects” would be substantial and negative.

“Our members and doctors would have increased liability if [hydrocodones] are rescheduled, and that will inevitably reduce prescribing,” she said. “We urge the DEA to make sure their decision is based on science and will make the situation better, not worse.”

And rarely are these decisions based solely on science.

Salmon – good for you or not?

Eat Your Salmon

Staying out of the sun and quitting smoking are both good ideas. But now some scaremongers want to add salmon to the list of things we all should avoid to reduce our risk of cancer.

Yes, salmon. The heart-healthy fish that’s also supposed to make you smarter stands accused of causing cancer. A study published in Science magazine last month says that salmon raised on farms in the U.S. and Europe has higher levels of pollutants than salmon caught in the wild. It recommends eating farmed salmon just once a month.

There are a number of fishy things about this study, starting with the fact that the proven health benefits of eating salmon far outweigh the risk of cancer. In response to the report, the Food and Drug Administration says that “consumers need not alter consumption of farmed or wild salmon at this point in time.” Britain’s food watchdog agency also rose to salmon’s defense, saying the levels of pollutants reported in the study are within internationally recognized safety limits.

Sometimes scientists perform solid studies but have unreasonable extrapolations of the data. From this report, we can surmise that to be the case here. I will not stop eating salmon!

Using BNP

Peptide May Help Predict Heart Diseases. Two articles appear in today’s NEJM which further our knowledge of B-natriuretic peptide as a diagnostic and prognostic blood test. My experience thus far (our VA starting doing them a few months ago) agrees with these articles. BNP is now part of my diagnostic and prognostic toolbox.

One of the studies, conducted at University Hospital in Basel, Switzerland, found that measuring the peptide’s levels in ER patients with shortness of breath helped doctors more quickly decide whether patients had heart failure.

That, in turn, reduced treatment costs and hospital stays by about one-fourth and lowered the percentage of patients hospitalized. The peptide test costs about $35.

The other study found that people with high levels of the peptide are three times as likely to develop heart failure within five years.

That study, funded mostly by the National Heart, Lung, and Blood Institute, examined 3,346 people. All of them are part of the Framingham Heart Study, which since 1948 has followed three generations and thousands of residents of the Boston suburb with regular physicals and tests.

“It’s a continuing success story for the biomarkers, and I believe they hold real promise for the future, both for the management of patients with urgent symptoms and for preventive strategies,” said former American Heart Association President Dr. Sidney Smith.

Smith said the findings should be considered when U.S. guidelines for diagnosing heart failure in ER patients are updated over the next year; European guidelines already call for the use of the test.

However, Smith said is too early to advocate widespread use of the test to predict heart trouble and plan preventive treatment.

Doctors believe a gradually failing heart tries to protect itself by secreting more and more of the peptide, which dilates blood vessels and lowers blood pressure.

IOM nutrient recommendations

Very interesting report – Institute of Medicine Advises on Water, Salt, Potassium Intake. The short summary: drink fluids moderately, water is no better than other fluids, eat less salt, eat more potassium containing foods.

HIV in college students

New H.I.V. Test Identifies Cases in College Students

This is a sad and tragic story. The new HIV test, which diagnoses infection soon after exposure is very interesting.

WHO on herbals

WHO Issues Guidelines on Herbal Medicines

The U.N. health agency on Tuesday issued advice to governments around the world on how to ensure that the $60 billion herbal medicine business is safe and sustainable.

“There is a huge increase in this market. Many people are paying a lot for traditional medicines, and some insurance systems have started to reimburse (for) traditional remedies,” said Dr. Hans Hogerzeil, acting direction of essential drugs and medicine for the World Health Organization.

“At the same time, this is an area where it is sometimes difficult to regulate properly and get safety assurance for patients.”

Medicines derived from plants, such as ginseng and echinacea, are becoming increasingly popular in rich countries and continue to be widely used in the developing world.

But the increase in popularity has been accompanied by an increase in the number of reported cases of damage to health from use of herbal medicines.

One cause is incorrect identification of plants. In the United States in 1997, people suffered serious heart problems after digitalis was accidentally substituted for plantain in dietary supplements. Fourteen cases of poisoning also have been reported in Hong Kong where the wrong root was used to produce an antiviral medicine.

Other problems include the use of poor quality plants, poor collection practices and the adding of other medications — such as steroids — to herbal remedies.

This is a huge problem. When will our Congress step up to the plate?

Two letters from physicians concerning malpractice

Letters to the Editor – Feb. 16, 2004

Drop current medical tort system in favor of arbitration boards
Recently I spent two weeks in a courtroom, and the two months prior in preparation for that appearance. Going to the courthouse every day, I was comforted, in an uncomfortable way, at the sight of other physicians. I nervously joked that it was like attending grand rounds. They, too, were there for malpractice cases.

After an emotionally arduous two weeks, the jury returned a verdict in my favor. The system seemed to work in the end, but I submit that it failed miserably for letting my case go as far as it did.

And

Absurd tort system pushes physicians to countersue

Regarding “Ob-gyn sues W.Va. trial lawyers” (AMNews, Jan. 26): While I agree that it seems reasonable to give lawyers a taste of their own medicine, unfortunately it degrades physicians by forcing us into playing their game.

However, until realistic reforms occur in this country (which take lawyers and juries out of the picture), countersuits appear to be the only way to bring attention to the absurdity of our medical tort system.

As Howard Beale said in Network – I’m mad as hell, and I’m not going to take it anymore. And that is how we physicians feel. We are tired of the absurdity of the current tort system.

From the AMA president

Lawyers who play the liability lottery must be stopped

A small subset of the legal profession makes fortunes for themselves — and creates costs for the rest of us — by suing physicians. Whether it is justified or warranted is, for them, beside the point. It is an abuse of the legal system — and it affects everyone.

This abuse is in the form of disingenuous lawsuits aimed at getting money from someone else — instead of seeking compensation for someone with legitimate claims. Some might call it legalized extortion.

These abuses are choking the health care system. They are sending medical liability insurance premiums soaring for thousands of physicians, making it impractical, or impossible, for them to practice in many parts of the country.

These lawsuits lead to other agonies as well. For a physician, a wrongful suit can cause great harm — embarrassment, loss of time, defense costs, injury to reputation and resulting loss of practice, stress and anxiety.

Meanwhile, cases with merit can take years to navigate an overloaded, confusing court system — as they wait their day in court behind a traffic jam of frivolous suits — brought by lawyers looking to win a litigation lottery — and then taking a huge chunk of the award.

Authoritative studies have shown that awards do not correlate with negligence and noneconomic damages can’t be objectively predicted. This creates an unstable environment akin to a chain reaction.

The trial lawyers who file the suits that breed this chaos operate in a system that imposes neither accountability nor restraint. The law puts up major obstacles to countersuits, and statutes that authorize sanctions for lawyers are rarely applied in medical liability cases.

More than 125,000 cases against physicians clog our nation’s courts on any given day. Yet 70% of cases filed are closed with no payment — and physicians win 80% of the cases that do go to trial.

Imagine the outcry if a physician had a record like that. As a surgeon, if 70% of the appendices I removed were normal, I would not be allowed to operate. Which is why I believe the medical community can agree that the time is right for a little peer review for the lawyers who file these worthless complaints.

We must fight back. We must oppose these lottery lawyers at every step. They are a curse to public health!

Time to fight back

Readers know my feelings about our current tort situation. Ohio physicians are fighting fire with fire – Ohio physicians fight back: Panel documents frivolous lawsuits

Wanted: Blatant examples of frivolous medical malpractice lawsuits filed against Ohio physicians.

Reward: A chance to recover the money spent defending the lawsuit and put lawyers on notice that physicians are going to stand up to meritless suits.

“We are looking to find the most egregious cases to bring forth as test cases in the court and shed light on the issue,” said Almeta E. Cooper, the Ohio State Medical Assn.’s general counsel.

OSMA hopes that its newly formed Frivolous Lawsuit Committee will give Ohio lawyers a disincentive to file baseless cases. The committee is believed to be the first of its kind formed by a state medical association.

OSMA is responding to an increasing number of physician members concerned that they are being named in “shotgun” lawsuits that include every physician listed on a chart. They also know of a few instances in which physicians were included even when their names weren’t in the chart.

Frivolous suits are a common complaint among doctors nationwide. Physicians and insurers say these cases are contributing to rising medical liability insurance costs that are forcing doctors to retire early, discontinue high-risk services or move to states that have enacted tort reform.

They point out that it still costs insurance companies thousands of dollars to defend lawsuits that are eventually dismissed.

“More than the money, physicians have to shut down their offices to defend the suits, and it’s an emotional strain,” said Findlay, Ohio, internist William Kose, MD, who has a law degree and is serving on the Frivolous Lawsuit Committee. “Physicians take lawsuits personally. Someone is telling them they did not do their job properly.”

But few physicians have challenged lawyers, and the success rate among physicians who have is small. OSMA hopes to change that.

Here is one blogging doc who is rooting for OSMA.

Things Bernie writes

Our frequent commentor, Bernie, often causes controversy. I am delighted with controversy. Often I just ignore his arguments, but today I will share some of comments and give me interpretation.

I’m trying as hard as I can to empathize with your depiction of the current malpractice crisis. Certainly there are undesirable consequences that flow from the current litigious atmosphere. But I can’t see how extra and possibly unneccesary medical tests or higher insurance bills for a well renumerated profession constitutes a crisis.

If you asked me what the health care crisis is, it’s how the cost of medical care rises year after year faster than the cost of living and how little effort goes into fighting iatrogenic illness, which now constitutes our worst public health problem.

Bernie – please show some consistency. The malpractice crisis helps cause the financial crisis. It contributes to the increasing cost of health care. Those unnecessary tests cost money. And their results often lead to more tests – and yes iatrogenic illness.

Sometimes doing an extra test leads to more testing and those tests can cause complications.

Physicians are generally scared to discuss errors as they worry about liability. Everyone tries to avoid being sued.

The malpractice crisis paralyzes change. Until we modify our tort system, we will not have the resources or energy to address iatrogenic disease.

You also overhype this problem. It pales next to self-inflicted disease.

And another great non sequitor from Bernie:

I’m looking forward to seeing Tagamet ads that proclaim it causes impotence.

An for as the dangers of supplements: perhaps you can enlighten me and name a supplement that kills more people annually than aspirin or acetaminophen. I think I’ll go make myself a cup of herbal tea — I like to live dangerously.

What a wonderful lack of connection! We have no idea what the danger of supplements is – because we have no required testing in the USA. That is the problem! We know the risks of prescribed drugs. We have reporting mechanisms, and physicians are alert to new dangers. With the supplement industry we have 2 problems: inadequate testing prior to selling supplements and inadequate standardization of ingredients. Without these two necessities, why would someone ingest these so-called remedies.

I drink herbal tea – for the taste. I do not take supplements from health food stores, because they just might hurt me. I want data that they help and do not hurt. I want to know that if a patient is taking a supplement – I can look up the ingredients and understand what he/she is taking. I want to understand how the supplements might interact with medications that I prescribe. I do not think that my desires to help the patient should be trumped by a dangerous law. Patients need to know what they are taking. Is that such an unreasonable request?

Frist on Democrats working to change the Medicare law

Frist Expects Congress to Try to Expand Health Coverage

Dr. Frist, a principal architect of the new law to provide prescription drug benefits to the elderly, accused Democrats of waging “huge campaigns to discredit” the law. He expressed concern that their criticism might sway voters.

“Democrats right now are out banging this thing and using very partisan criticism, trying to tear it down, because they see that it is a huge leap forward,” Dr. Frist said.

Mr. Bush takes credit for adding drug benefits to Medicare, a goal that long eluded Democrats. But Democrats are determined to turn the issue to their advantage by highlighting what they see as defects in the law.

“This is an opportunity for Democrats, but they must seize it and work to define the terms of the debate,” says a memorandum for Congressional Democrats by Al Quinlan, president of Greenberg Quinlan Rosner Research, a political consulting concern. “It is critical to engage aggressively and not allow Bush and the Republicans to shape the dialogue.”

To win the debate, the memorandum said, Democrats should “define the current law as unacceptable, not as something that can be fixed.” Though “voters start with a slight inclination to support the law,” it continued, they swing decisively against it when they are told that Medicare beneficiaries will face high out-of-pocket costs, high drug prices and gaps in coverage.

I worry that the politics of health care will undermine real progress. The Democrats do not seem to care whether this law helps some patients. They will not admit that having a drug benefit, even with some gaps, trumps having no drug benefit.

They see any law purely for its political ramifications. But then the Republicans are no different here. Politics trumps the common good at all times. In years past, the Congress and Senate understood compromise. The two parties worked together to at least try to craft positive legislation.

The Medicare bill is not perfect. But then neither am I, or you. Frist is right that we should watch what happens for a year or two prior to making more radical change (because this law is radical change).

Why John Edwards scares me!

Yesterday I linked to Sydney Smith’s piece on Edwards. One of my most frequent commentors – Bernie – had this to say:

I read the article you linked to and it had lots to say about defensive medicine as a consequence of malpractice litigation and little to say about Senator Edwards’ supposed misconduct as a malpractice lawyer. Unless you assume taking malpractice cases is prima facie evidence of moral depravity, I have yet to see how any of these opinion pieces impeaches Senator Edwards’ character.

Bernie and I often disagree – and we both give and take arguments well. I really have not problem with his character, rather his apparent philosophy scares me. Rangel has a great post on this – How Edwards and his ilk are destroying America Quoting from Rangel-

Despite such manipulation of the court system, as repulsive as it is to rational, thinking Americans who have a sense of fairness and justice, a surprising number of people feel that this kind of behavior is perfectly acceptable as long as there is a sense that some type of “justice” has prevailed. This mentality goes along with the commonly held idea that things are not supposed to go wrong without someone else being responsible for causing it. This is a mentality that trial lawyers like Edwards have successfully cultivated over the last 40 years. Americans are more suspicious about big government, big business, industry, and professionals like their own physicians. If something goes wrong then someone is to blame. Call the lawyer!

Obviously, physicians and lawyers view the world through different prisms. (Well maybe not all lawyers, but likely most trial lawyers). These prisms differ due to a fundamentally different motivation for our professions.

Physicians have the patient’s well being in mind as a first priority. We “adjudicate” information to try the best known therapy for our patient. We espouse evidence based medicine as our goal. New studies change our practice (the recent data on HRT represents a study which has caused a sea change).

We often will consult a colleague if we believe that the colleague can add valuable insights into our patient’s care.

The job of the trial lawyer is to win the case for his/her client. Some lawyers take cases to change policy. But most cases are chosen for monetary benefit. The underlying principle is to win.

There are exceptions to this generalization, however, it is not the lawyer’s job to worry about the health care system. He/her will often put the client’s interest above the greater good. That is the nature of the lawyer/client relationship and of trial law in this country.

I believe that lawyers like John Edwards undermine our medical system. They can ignore data, science and greater good, and they do regularly. They are doing their job – and Edwards does that job well.

I admire his skill, but I disdain what his cases do to our health care system. I do not blame him, but I do not want someone with his attitude about the law as my president.

We need tort reform, and not just in medicine. With Edwards in power any hopes of reform would vanish. The court system, as used in this country, does not protect the public good. It does not evaluate the scientific evidence as scientists do.

We need a change, and since Edwards represents the current sorry state of affairs, he scares me.

Sydney Smith on Edwards

Edwards scares me. He scares Sydney also – Our Edwardian Healthcare System

Clapping for the FDA

Tell the consumers about side effects! US FDA Wants Ads for Medicine to Highlight Risks

Prescription drug advertisements should highlight key risks rather than just list a string of possible side effects in tiny print, U.S. regulators said in new guidelines unveiled on Wednesday.

“Consumers want and deserve information presented in a way that’s clear, accurate and understandable,” Food and Drug Administration Commissioner Mark McClellan said.

To which I must clap wildly! Now let us have the same guidelines for supplements and then I will do a jig!

On auto safety

Perhaps this is a stretch, but one can argue that we should provide safety advice. If that argument does not convince you, then just read the article anyway. I admire Malcolm Gladwell and wait eagerly for his New Yorker pieces, which I consider the best medical/science reporting that I read. Big and Bad: How the S.U.V. ran over automotive safety. That SUV is more dangerous than your smaller cars!

On teaching hospitals

I recently blogged about academic medicine – stimulated by our favorite surgeon blogger, Bard Parker. He has pointed out this important article concerning academic teaching hospitals – Multiple Missions Put Teaching Hospitals at Risk

For more than a century, Americans have expressed confidence that an ever-increasing, well-trained cadre of physicians and medical scientists will protect and enhance their health. So for much of this period, the steady expansion of medical schools, research laboratories and teaching hospitals has been justified as an agent of public good.

More recently, however, with the fiscal crisis in health care, experts are beginning to question whether the nation’s academic medical centers are financially sustainable in these times when Americans tend to worship the free market.

It has become increasingly difficult in recent years simultaneously to educate and train young doctors, treat patients, advance medical research, and hew to the bottom line. All these endeavors require more and more costly technology. Salaries and health care delivery expenses continue to rise. And the competition among all medical centers, whether affiliated with universities or independent, is ferocious.

The academic medical center is big business. Because it is big business, we often have mission confusion. At times the medical school and the hospital administrations are at war.

So what should the priorities be? Are academic medical centers chiefly about education, or research, or patient care? Given current finances how many academic medical centers will remain “triple threats”?

What has changed most over the past century is that today’s academic medical centers are almost or completely financially independent from their parent universities. To make matters more precarious, when economic times are good, many university presidents look to their hospitals’ profits to support other growth plans in the less lucrative schools or colleges. But when these revenues are threatened or reduced, they often seek ways to minimize the university’s financial responsibility to its academic medical center.

“This places an enormous premium on the entrepreneurial skills of administrators and faculty and seriously threatens the older notions of humanitarianism and scholarship that guided these institutions,” Dr. Risse said.

Dr. Ruth Macklin, a bioethicist at the Albert Einstein College of Medicine in the Bronx, observed, “Academic medical centers are caught in a squeeze to bring in more and more dollars, leading to the common doctors’ complaint: `I just don’t have time to talk to patients because I am not reimbursed for it.’ ”

Dr. Arthur L. Caplan, a professor of medical ethics at Penn, believes this tension may be largely generational in nature. “Older physicians and medical scientists who came of age before the end of the 1980’s tend to be more concerned about the public service mission of academic medical centers than their students, who are very much the product of the concept of medicine as a business,” Dr. Caplan said.

So we have these large businesses that care for complex patients, perform major research projects and, oh by the way, train our future physicians (both students and residents). With these multiple missions, few centers do all well. And too often the education piece suffers.

The supplement industry redux

Oh, but this reminds me of the famous tale – The Emperor’s New Suit. There is nothing there (speaking of the industry) and yet many Americans spend large amounts of money on supplements.

At the risk of offending a reader, I will quote from his diatribe concerning Sunday’s rant:

As a chiropractor, I’m a part of the alternative trend. I realize some reigns need to be put on herbs and other so-called alternative therapies, but I don’t think we need to dismiss the right of the patient to make their own educated decision. After all, a patient is not going to keep up with something that is harmful to them, unless their doctor tells them to. If millions, thousands, heck hundreds within a year were suffering problems from these herbal supplements, the word of mouth of their failure would kill the sales.

So he uses sophistry (see yesterday’s rant) to argue for alternative therapies. I am a simple minded physician. I need data. I want to see what happens to patients who receive a therapy – do they improve or do they get worse or does nothing happen. Clearly, I try not to prescribe medications that have no effect.

The commentor urges us to allow patients to make their own educated decision. Unfortunately, many patients cannot make an educated decision about their medical care.

This argument stems from the general argument between science and belief. As a scientist, I want evidence that a therapy both will increase the probability of helping me and have a limited probability of hurting me. I certainly do not want to spend large amounts of money on placebos.

The commentor argues that patients know. Of course, in the land of believers the anecdote is king.

I’m sure we all know how statistics can be used to get results we need, or at least point our direction. Everybody knows that if you flip a “roll-over” prone SUV that it was probably your fault. If the plane craches, well that was out of your hands. Personally I like to have control of the reigns, like most Americans.

This is a simply classic diatribe against medical statistics. We should not trust statistics – because they define outcomes precisely .

With no apologies, this reasoning leads to many patients down the wrong roads.

Many patients are not smart about their health. If they were they would not smoke, drink to excess, have multiple sexual partners, use IV drugs, or become obese. But they do!!! People often do not know what is best for them.

Ephedra “helped” many patients – but at the risk of death! Patients died because of a bad law. Perhaps they should sue Congress (oops – you cannot really do that).

We need a better law. We need to advance evidence as the determinant of medical decision making. When we have no evidence and someone wants to try either an off-label drug or a dietary approach – I have no objection, if, and only if, the patient fully understands the lack of data and the potential risks.

The dietary and supplement industry presents themselves as authoritative. They are not, and they hurt many patients. Fortunately, they mostly just bilk naive believers out of their money. That is bad enough.

Malpractice – the games lawyers play

Malpractice cases often are about the money, not justice. Read this article for some outrageous examples (I know the Bloviator will argue that the exceptions are just that – but these cases are real and do hurt physicians). – Lawyers try new tacks in malpractice suits

 

• Last year, an Ohio jury awarded $3.5 million to the family of a man who died of a heart attack.His family claimed that the physician didn’t do enough to help the man lose weight and stop smoking, given that physicians now know how smoking and excess weight contribute to heart disease and given the significant advances in treatment.
• Florida resident Miriam Kamin, along with her husband and son, filed a medical malpractice claim against Baptist Hospital of Miami and several of its physicians in 2002. Instead of claiming the standard of care wasn’t met, the woman argues that she should have been referred to a hospital down the street to have a low-grade pancreatic tumor removed.
• In Ohio, the basis of a case against a Dayton physician practice is that a medical test was not performed according to the standard of care. But the facts leading up to the claim offer a different twist on the law.The patient, John Dobran, is suing because he says he is being denied the best information possible on whether his melanoma could return. The Ohio Supreme Court is poised to decide whether he has a claim.When doctors discovered that a mole on Dobran’s arm was malignant melanoma, Dobran decided that he wanted a sentinel lymph node biopsy. By harvesting the lymph nodes first encountered when melanoma metastasizes, doctors can determine the chances of the cancer coming back.

  The tissue had to be sent to a lab in California. But it thawed before it arrived, making it untestable, and Dobran now wants to be compensated for the emotional pain and suffering of not having those results.

These examples are (in my not so humble opinion) outrageous! We need a filter prior to jury trials – or no jury trials at all. Our system encourages lawyers to gamble on the big hit. They know that they can convince jurors, regardless of the facts. From Webster’s

sophistry

n : a deliberately invalid argument displaying ingenuity in reasoning in the hope of deceiving someone [syn: sophism]

The fundamental underpinnings of our legal system have nothing to do with sophistry. Yet sophistry wins cases. We need a system that protects us against these tactics.

The New Yorker on the dietary supplement industry

I will probably go buy this issue to have a better, more readable copy of this article. The author has done outstanding research and puts the entire industry into both historical and current perspective. I hope this link lasts (not sure about the New Yorker’s links) – MIRACLE IN A BOTTLE

I will quote a few key paragraphs to make some points and highlight the issue:

The diet-pill business may be the most visible segment of the vitamin-, mineral-, and herbal-supplement industry, but it is by no means the largest. Thousands of different tablets, elixirs, potions, and pills are sold in the United States, and remarkably little is known about most of them. That doesn’t deter consumers. Since 1994, when Congress passed a law that deregulated the supplement industry and opened it to a flood of new products, the use of largely unproved herbal remedies – from blueberry extract for impaired vision to saw palmetto for the treatment of enlarged prostates and echinacea to prevent colds – has increased as rapidly as the use of any commonly prescribed drug.

Since that legislation, the Dietary Supplement Health and Education Act, became law, companies have been able to say nearly anything they want about the potential health benefits of what they sell. As long as they don’t blatantly lie or claim to have a cure for a specific disease, such as cancer, diabetes, or aids, they can assert, without providing evidence, that a product is designed to support a healthy heart (CardiAll, for example), protect cells from damage (Liverite), or improve the function of a compromised immune system (Resist). There are almost no standards that regulate how the pills are made, and they receive almost no scrutiny once they are, so consumers never truly know what they are getting. Companies are not required to prove that products are effective, or even safe, before they are put on the market.

Those two paragraphs nicely summarize the effects of the DSHEA.

Since then, the English language has been stretched to its limits in the attempt to link products to health benefits. Even claims that are true may be irrelevant. Vitamin A, for example, is important for good vision – as supplements for sale in any health-food store will tell you. Insufficient consumption of Vitamin A causes hundreds of thousands of cases of blindness around the world each year, but not in the United States; here people don’t have vision problems arising from a lack of Vitamin A. Although statements advertising Vitamin A for good vision may, like many others, be legally permissible, they are meaningless. “The laws allow manufacturers to make fine legalistic claims,” Paul M. Coates, the director of the Office of Dietary Supplements at the National Institutes of Health, told me. “What we now have is an entire cottage industry of creative linguistics dedicated solely to selling these products.” Instead of mentioning a disease (which in most cases would be illegal without F.D.A. approval), companies make claims that a food can affect the structure or function of the body. Such claims can appear on any food, no matter how unhealthy it is. You cannot assert that a product “reduces” cholesterol, but you can certainly say that it “maintains healthy cholesterol levels.” You cannot state that the herb echinacea cures anything, since it has never been shown to do that. But there is no prohibition on stating that it “has natural antibiotic actions” and is considered “an excellent herb for infections of all kinds.” Gingko biloba has been recommended to Alzheimer’s patients because it “supports memory function.” Does it? Since research is not required before a supplement is released, there are not nearly enough data to know.

Obviously the key here is the advertising. You can obviously sell almost anything to some people with good enough advertising. Data are irrelevant.

One recent Harris poll found that most people believe that if a supplement is on the market it must have been approved by some government agency (not true); that manufacturers are prohibited from making claims for their products unless they have provided data to back those claims up (no such laws exist); and that companies are required to include warnings about potential risks and side effects (they aren?t). “When something goes wrong, though, most people expect government health officials to find a solution,” David A. Kessler told me. Kessler, who is the dean of the School of Medicine at the University of California at San Francisco, was the F.D.A. commissioner when Congress passed the Dietary Supplement Act, which he adamantly opposed. “This is really the classic American ambivalence, and it has always been part of our nature,” he said. “The view of most people is simple: I want access to everything and I want it now.” The Federal Trade Commission – not the F.D.A. – regulates supplement advertising. But the F.T.C. is principally concerned with commerce, not science: it focusses on the content of the labels, not the content of the pills. Although since 1994 the agency has sued more than a hundred diet-pill companies, in 2002 it found that at least half of all weight-loss ads contained false or misleading statements. Despite its vigilance, the agency has an impossible job; for each success, ten new companies seem to appear.

When people get sick, Dr. Kessler pointed out, the refrain is always “‘Where the hell is the F.D.A. to protect me’? The supplement industry doesn’t have to report adverse events, so the F.D.A. doesn’t have the data it needs to protect people. You cannot prove something is unsafe if you don’t have the data. It’s the ultimate Catch-22. It is also a colossal failure to protect the public health of this country.”

I hope that these excerpts have whet your appetite to read the best single overview of the dietary and supplement industry that I have yet read. DSHEA respresents the worst of our political process. The government has put the citizenry at both health and financial disadvantage. I hope that common sense and good science can prevail. Unfortunately, I am skeptical.

More on Edwards

A vote for Edwards would be a vote against malpractice reform. A reader emailed me to comment on Medpundit’s post from yesterday. I can only say – brilliant – Fortune’s Son