Archive for February, 2008

House Calls

Friday, February 29th, 2008

Way back when, during a hiatus while awaiting for word on a grant application, I was a GP seeing mostly rural patients up in the Connecticut hills north of Simsbury. House calls were frequently required. One late evening I was called to see a sick lady for a “bad cough and fever.” Walking into shabby living room of a small farmhouse off the main road, I was ushered into the sparsely furnished bedroom by a tall, middle aged woodsman, unshaven, who looked vaguely menacing, reminiscent of a New England redneck. Sitting on one of the twin beds was a thin, almost skeletal lady looking much older than her stated age of 58. The patient was flushed, with fairly rapid breathing and a temperature of 103.

After draping the patient and asking her to take off her blouse, I began listening to her heart and immediately heard loud murmurs indicating valvular heart disease, along with loud crackles in her lungs, a sign of complicating pneumonia. By this time, her husband who had been lurking next to the patient and staring wide-eyed at me, suddenly left the room, returning with a large shotgun. Pointing the gun in my direction, he announced, “That’s enough. Get out!” I was dumbstruck, but though concerned about about the sick wife, I quickly departed.

The next day I told Ed, my older partner what had happened. He did not seem surprised, but explained simply, “Oh! that’s Clive Johnson. The guy’s crazy; always pulls something like that when you try to examine his wife. ”

P.S. The patient recovered after seeing Ed that afternoon. I never asked him if Clive was around when he examined her chest.

The FDA and Us

Friday, February 22nd, 2008

The National Academy of Science’s Institute of Medicine, the Government Accountability Office, and the F.D.A.’s own science board, along with numerous independent groups have raised serious questions over the effectiveness and competence of the Food and Drug Administration. Specifically, these Government agencies have all issued reports concluding as reported in the New York Times “that poor management and scientific inadequacies have made the agency incapable of protecting the country against unsafe drugs, medical devices, and (even) food.”

For the first 86 years of FDA’s existence, from 1906-1992, all of its funding came through the U.S. Treasury. In other words, industry and the public paid their taxes, and FDA got appropriations out of the budget. If the FDA made a mistake, many of which occurred over the years, there would be a congressional hearing. The Agency would be accountable to the public through the legislative branch and explain what went wrong and why.

In 1992, unfortunately, the entire regulatory landscape was changed profoundly as the result of a new law which was passed. The law required that much of the cost expended by the FDA on new drug applications would come directly from industry. In other words, to get a drug or device reviewed, the manufacturer would pay directly to the FDA. To understand how this legislation created a cozy relationship between industry and the Agency that regulates it, see this interesting interview. There it is explained why we are seeing an explosion in class action lawsuits against drug companies, the results of “fast track approvals” and increasing numbers of new drugs and devices being withdrawn from the market.

Direct-To-Consumer Drug Advertising

Thursday, February 14th, 2008

Prescription drug marketing directly to the consumer, can include virtually any class of prescription drugs, and is routinely permitted under U.S. law. Notable, is the profoundly different regulatory environment in the European Union (EU), Australia, and Canada where pharmaceutical manufacturers are forbidden to advertise prescription drugs to the public. In point of fact, the U.S. is one of only two countries in the world (the other is New Zealand) where it is legal for drug companies to advertise to the public.

Such “direct to consumer” or DTC advertising is meant, obviously, to create increased patient demand for specific drugs from their doctors. In this scenario, patients really become consumers, replacing the doctor as prescriber, if the physician is foolish enough to surrender his authority. Consumer Reports, in a 2006 survey found that 78 percent of doctors said that patients asked them at one time or another to prescribe drugs they had seen advertised on television.

While Congress recently gave the FDA more authority to regulate ads, it rejected a measure that would have allowed to agency to place a moratorium on ads for new drugs that raise safety concerns. The sad fact remains that Congress seems in no mood to address the main problem, the legality of advertising drugs to the public.

Don’t expect the ad barrage, TV or otherwise, to subside any time soon.

Medical Guidelines and Medical Consensus-II

Friday, February 8th, 2008

Most consensus policies are still achieved by selection of expert panels or organizations whose opinions conform to each other. Far too many professionals, insurance companies and other healthcare organizations are eager to follow the latest schematic orthodoxy, whether it be the “standard” for treating advanced cancer, or the decision to perform invasive studies. These so-called “Medical Guidelines” are often far from uniform or consistent.

A few years ago in the Lancet, an editorial pointed out that The American Medical Association listed 2200 guidelines, and that within 6 weeks in the same year two governmentally sponsored groups issued opposing guidelines on screening mammography. There continue to be multiple guidelines for mammography as well as prostate and other cancer screening. For example, guidelines for colon cancer screening differ between the National Cancer Institute and the American Cancer Society as well as the American Society for Gastroenterological Endoscopy. Up to 50% of cardiologists in a previous national study disagreed on indications for invasive studies. When ill-conceived guidelines like the preference for early upper endoscopy over the barium X-ray, edge into “Community Standards of Care” they cause untold medical mischief, if not economic havoc. Far too often they express specialty bias and by implication economic self-interest. A study reported in the Journal of The American Medical Association, reported that 72-90% of physicians writing clinical practice guideline articles show conflict of interest.

Consensus, according to Webster, is “agreement in the judgment or opinion reached by a group as a whole.” Despite the problems of bias and self-interest, clearly the practice of medicine cannot exist without a considerable degree of consensus. The democratization of medical opinion has been on balance a powerful and useful, if not a breathtaking development. Darryl F. Zanuck, the film producer once remarked, “If two men on the same job agree all the time, then one is useless. If they disagree all the time, then both are useless.” Unlike pornography and pestilential politics, you don’t necessarily know medical consensus when you see it, since it depends so much on who is doing the talking, and perhaps why.

Medical Guidelines and Medical Consensus-I

Thursday, February 7th, 2008

A climatic change has occurred in the practice of medicine, resulting from the changing economics of healthcare delivery and a new participant mentality. This has been driven by professional organizations and especially the Government. This conceptual shift was accelerated by the Medical Guidelines Movement in the United States in the mid-1980’s when thanks to the emergence of “evidence-based medicine”, a major area of policy focuses on “Outcomes and Effectiveness and Technology Assessment.” Thus was born The Agency for Health Care Policy and Research (AHCPR) who has invited just about everyone from health care organizations to other public- and private-sector entities to submit their clinical practice guidelines for inclusion in the National Guideline ClearinghouseTM (NGC), a comprehensive electronic database.”

In addition to these and other Government-sponsored sites, physicians, health plans, patients, and hospitals are constantly deluged by an archipelago of professional societies and organizations, mostly devoted to their own area of interest, submitting and issuing periodic guidelines and consensus opinions. You’ll be pleasantly surprised by NGC’s very candid disclaimer, though defined in the most compelling Governmental officialese, says in part:

“The NGC database contains evidence-based clinical practice guidelines as defined by the Institute of Medicine (IOM):

    “Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.” (Sounds groundbreaking, doesn’t it?, but hang on.)

These guidelines are not fixed protocols that must be followed, but are intended for health care professionals and providers to consider. (My emphasis) If you require more reassurance, see the Federal Register, the final word on Governmental regulations having legal effect. Federal Register (CFR Vol. 63 no. 70) officially defines Clinical Practice Guidelines, but publishes not a single guideline.Should We Worry?

Most consensus policies are still achieved by selection of expert panels or organizations whose opinions conform to each other. Far too many professionals, HMO’s, and other healthcare organizations, even sophisticated patients, are eager to follow the latest schematic orthodoxy, whether it be the “standard” for treating advanced cancer, or the decision to perform invasive studies. These standards, described as “Medical Guidelines” are often far from uniform or consistent.

More tomorrow…

Casualties of War: Untold Story

Monday, February 4th, 2008

According to internal Army documents, reported in previous years, and yesterday again by CNN, the number of attempted suicides or self-inflicted injuries in U.S active duty soldiers is rising at an alarming rate. This figures, derived principally from those serving in or returning from Iraq and Afghanistan, have gone from approximately 350 in 2002 to more than 2,100 last year (2007). The number of suicides among active military service members, reached their highest level since the Army began keeping such records in 1980, 121 suicides in 2007, 20% higher than in the previous year.

Casualty, defined by Webster’s is “a military person lost through death, wounds, injury, sickness, internment, or capture or through being missing in action” or, “b: a person or thing injured, lost, or destroyed.” Casualty figures for U.S. and coalition forces, both civilian and military in Afghanistan and Iraq are reported at this site. American deaths in Iraq now approach 4,000 since the war began, with over 50,000 serious injuries, including over 8,000 severe limb injuries and estimated amputations, anywhere from 423 to almost 1,000 in other reports. Iraqi civilian deaths have been estimated at over 100,000 and total casualties over 832,00 since the U.S. invasion.