Sometimes you read another blog and find a pearl. Today is such a day.

There’s No More Cherry Cola

Spironalactone for diabetic nephropathy

Diabetic nephropathy clearly causes more end stage renal disease than all other causes combined (in the US). As we understand more about the pathophysiology of diabetic nephrpathy, we have a better chance of retarding progression. ACE inhibitors and ARBs both decrease proteinuria and slow progression. This has led researchers to wonder if blocking aldosterone would work also. Now we know – Adding Spironolactone to ACE Inhibitors May Reduce Albuminuria in Type 2 Diabetes

Adding a low dose of spironolactone to a standard angiotensin-converting enzyme (ACE) inhibitor reduces albuminuria in patients with type 2 diabetes, according to preliminary findings of a pilot study. The effect was seen in patients with both microalbuminuria and macroalbuminuria, and the addition caused no adverse effects, including no significant hyperkalemia.

This is not ready for prime time – but the preliminary data are intriguing.

More on scientific principles and the courts

The ongoing commentary on my recent post about courts and scientific principles is interesting reading. As usual I have strong opinions.

This discussion really should focus on a fundamental question about medical practice. What should be our standards of evidence for modifying practice. I suggest that web sites like this one should inform our debate – Centre for Evidence Based Medicine

One of the first principles that we learn concerning evidence based medicine is that we must examine the quality of the evidence. The least persuasive level of evidence comes for single case reports.

In the case which stimulated my first post, an expert refers to 1 case report of the concordance between high dose statins and a patient who developed polymyositis. This one case raises an interesting hypothesis, but just cannot be considered medical evidence. It does not meet the standard which physicians expect.

As I see the debate, physicians are expected (by other physicians and society) to practice evidence based medicine. If we do that, should a court ignore those principles in their acceptance of legal evidence.

I personally find this both an important philosphical and practical question. If we use the word evidence differently, then frustration will occur.

It is possible that statins can, under rare circumstances, cause polymyositis. It is more likely that they do not (my reasoning here is that with the large number of patients on statins, such an association would not go unnoticed).

We who favor special health courts believe that this story provides a classic example of poor definitions of evidence. We expect the same definition of evidence for our medical practice and any judgment of malpractice. Having a son in law school, I understand (because he has explained this clearly) that the legal definitions of acceptable evidence are very different from the medical definitions.

Most physicians would consider any standard which allows a single case report as an unreasonable standard. If the courts accept such evidence, then we must consider such a decision a poor one. Our belief comes from a set of scientific principles which we try to follow.

I expect our lawyer friends to explain that we do not understand the legal issues here. I respond that we understand these issues all too well.

The P4P discussion

Both my colleague, Dr. Barr, and several commenters point out that “the train has left the station”. By this I assume that they mean that P4P is inevitable, so quit whining.

I certainly will work to try to make P4P meet the highest standards. However, I have a responsibility as a blogger to scream at the top of my lungs when I think something is wrong. Yes bloggers have responsibilities. You need not agree with me, but I hope I at least make you think.

P4P looks good on the surface, but I still fear its consequences. If I do not blog about this then I am not true to my principles.

Trains can be stopped. I hope that we can approach the P4P concept with rational evidence. What happens when one implements P4P. Does health care improve or just change? We must know the answers prior to spending much money on a scheme that I believe will work in perverse and unknown ways.

Patient interactions – an interesting view

I really like Abigail Zuger’s writing in the NY Times. She clearly has the gift for personalizing topics related to the doctor patient relationship. Today’s essay – How a Spoonful of Sugar Helps the Medicine Go Down

Instead of quoting from the article, I will provide my own thoughts. As I have written before, my favorite question for patients (usually I ask this after the present medical history) is, “What do you do for fun?”. This is both a depression screening question (in my opinion the highest yield when you do not expect depression) and a way to connect with the patient. Once I know what the patient enjoys, I have a safe place to go for small talk. Small talk is important.

Some would say that Southerners expect small talk even more than those in other parts of the country. Few business meetings start in the South without some chatter unrelated to the business at hand.

Working in the hospital, I have learned to quickly (and usually successfully) figured out how to develop the proper relationship with each patient. Some like the diversion of small talk; others want to only focus on business.

As Dr. Zuger understands, she can say some things that I cannot, merely as a result of gender. So I stick to topics like sports, fishing, trips, grandchildren, etc.

Small talk is not a diversion, but a way of making both sides of the interaction more personal. When I start to understand the context of the person, I believe I am much better able to help them. Likewise, unlike some physicians, I have no problem in sharing appropriate parts of my life with patients, e.g. sports teams I root for, my love for golf, a movie I saw.

Please read Dr. Zuger’s essay – it is well worth your time.

When the courts ignore scientific principles

New York appeals court allows single-case evidence (AMA News subscription required)

The case, Zito v. Zabarsky, stems from a November 2003 trial court hearing to screen expert witness testimony. New York courts require the testimony with the plaintiff’s filing of a medical liability case to determine the validity of claims made. Judges follow the Frye standard, derived from a 1923 federal ruling that established that novel scientific evidence presented in court must “have gained general acceptance” in the relevant scientific community.

Pamela Zito sued Queens internist Gary Zabarsky, MD, alleging that he had prescribed her an “excessive” dose of the cholesterol drug, Zocor (simvastatin), which caused her to develop an autoimmune disease, court records show. Dr. Zabarsky denies the allegations.

The physician first prescribed 20 mg of another statin drug, Pravachol (pravastatin), to Zito, which he later increased to 40 mg. He then changed Zito’s prescription to 80 mg of Zocor, the highest recommended daily dose. Shortly after taking the medication, Zito was diagnosed with polymyositis.

Zito’s experts, a pharmacologist and an internist, conceded that there were no studies that linked polymyositis to the Zocor therapy, according to court records. But they presented a single report in a May 1997 article from the medical journal The Lancet of a patient who had developed polymyositis after taking a generic form of Zocor.

Zito’s experts explained that she developed a well-known side effect of the drug, a muscle condition called myopathy, which could have triggered the release of an antibody associated with polymyositis. As a general principle, the experts further said, the bigger the dosage of a drug, the bigger the effect it will have on a patient, court records show.

The trial court dismissed the case, finding that the experts did not include any peer-reviewed medical literature to support the theory.

The appeals court reversed that decision. Although the judges agreed the medical opinion was “novel,” they determined that the “dose/response” principle and the other evidence was sufficient to support Zito’s claims.

The trial court “apparently believed that the Frye test could only be satisfied with medical texts, studies or other literature which supported the plaintiff’s theory of causation under circumstances virtually identical to those of the plaintiff. However, the Frye test is not that exacting,” Judge Daniel F. Luciano wrote.

The appeals court also expressed concern that under a strict interpretation of the standard, “first users of a new drug” would not be able to sue if they were injured.

This ruling is simply outrageous. If we practice medicine based on a single case report, we are fools. We need evidence, and one case report is not evidence. Case reports can generate new hypotheses, but they cannot prove anything.

I cannot fathom what the appeals court is thinking.

A possible new quality measure?

NY Times opines on the medical marijuana debate

F.D.A.’s Report Illuminates Wide Divide on Marijuana

“There’s sort of a détente,” Mr. Barankin said, in California. “Both sides respect that we have laws that differ. Federal law enforcement agencies for the most part have shown some respect for California law by only going after those individuals who seem to be clearly not in the medical marijuana business for the medical part of it — which are the same people the state law is going after.”

The Food and Drug Administration issued its announcement in response to calls from opponents of medical marijuana in Congress, and it was welcomed by the White House Office of National Drug Control Policy, which has long made marijuana its top priority.

Advocates of medical marijuana said the real impact would be in trying to pass new legislation in states like Connecticut, New Jersey and New Mexico.

“We’re going to have members of state legislatures say, ‘But even the F.D.A. has said there’s no medical value,’ ” said Ethan Nadelmann, executive director of the Drug Policy Alliance, which works to loosen drug laws. “That’s where it’s going to hurt.”

The Supreme Court decision killed efforts to allow medical marijuana in Connecticut, Mr. Nadelmann said, adding, “It had no legal impact, but it created a perception.”

Others said the decision would continue to frustrate efforts to research the potential medical benefits of marijuana.

In Vermont, for example, a statute enacted several years ago called for a research program on the therapeutic effects of marijuana. When a legislative group asked more recently why that had not been conducted, the Vermont Health Department said it could not be done under federal law, Mr. Treadwell said.

We know that marijuana ingredients have therapeutic value. Good science would suggest that we compare individual ingredients with the complex ingredients in smoked marijuana. If there is no difference, then we could settle this issue. We can prescribe narcotics. We can do research using narcotics. Narcotics are clearly much more addictive and dangerous (albeit useful in therapeutic situations) than marijuana.

The federal handing of marijuana over the past 50 or more years continues to have no logic. They send a message to many citizens that contradicts their experience. When laws do not conform to common sense, then I believe our social contract is damaged.

FDA contradicts IOM

You have seen the news stories. F.D.A. Dismisses Medical Benefit From Marijuana

The Food and Drug Administration said Thursday that “no sound scientific studies” supported the medical use of marijuana, contradicting a 1999 review by a panel of highly regarded scientists.

The announcement inserts the health agency into yet another fierce political fight.

The problem is that the IOM concluded the exact opposite.

The Food and Drug Administration statement directly contradicts a 1999 review by the Institute of Medicine, a part of the National Academy of Sciences, the nation’s most prestigious scientific advisory agency. That review found marijuana to be “moderately well suited for particular conditions, such as chemotherapy-induced nausea and vomiting and AIDS wasting.”

Dr. John Benson, co-chairman of the Institute of Medicine committee that examined the research into marijuana’s effects, said in an interview that the statement on Thursday and the combined review by other agencies were wrong.

The federal government “loves to ignore our report,” said Dr. Benson, a professor of internal medicine at the University of Nebraska Medical Center. “They would rather it never happened.”

Some scientists and legislators said the agency’s statement about marijuana demonstrated that politics had trumped science.

“Unfortunately, this is yet another example of the F.D.A. making pronouncements that seem to be driven more by ideology than by science,” said Dr. Jerry Avorn, a medical professor at Harvard Medical School.

I know both the highlighted physicians. They are not radical. They are excellent scientists.

This ruling seems to be entirely driven by political concerns. It is disappointing.

A debate on pay for performance

I was recently invited to participate in a debate on P4P. It is available on Medscape – April 2006: Point/Counterpoint on Pay for Performance

Please let me know what you think!