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Time to Care: Personal Medicine in the Age of Technology

In 1925, Francis Peabody famously said “The secret of the care of the patient is in caring for the patient.” A new book by Norman Makous, MD, a cardiologist who has practiced for 60 years, is a cogent reminder of that principle.

In Time to Care: Personal Medicine in the Age of Technology, Dr. Makous tackles a big subject. He attempts to show how modern medicine got to where it is today, what’s wrong with it, and how to fix it. For me, the best part of the book is the abundance of anecdotes showing how medicine has changed since Dr. Makous graduated from medical school in 1947. He gives many examples of what it was like to treat patients before technology and effective medications were introduced. He describes a patient who died of ventricular fibrillation before defibrillators were invented, the first patient ever to survive endocarditis at his hospital (a survival made possible by penicillin), a polio epidemic before polio had been identified as an infectious disease, the rows of beds in the tuberculosis sanitariums that no longer exist because we have effective treatments for TB. He tells funny stories: the patient who was examined with a fluoroscope and told the doctor he felt much better after that “treatment.” He describes setting up the first cardiac catheterization lab in his area. No one who reads this book can question the value of scientific medicine’s achievements between 1947 and 2010. Today we can do ever so much more to improve our patients’ survival and health. But in the abundance of technological possibilities, the crucial human factor has been neglected.

Individualized care, which involves the use of science-inspired technology, is not personal care. Alone, it is incomplete. It does not provide the necessary reassurance that can only be provided through a trusted physician who focuses upon the totality of the person and not just upon a narrow technological application to a disease. Time and personal commitment are needed to build the mutual understanding and trust that are fundamental to personal care….the continued acceleration of science, technology, and cost has intruded on personal care in our country. This has also occurred during a time in which American individualism and its accompanying sense of entitlement have become more of a cult than ever before. In the absence of personal attention, patients demand more testing, but testing does not satisfy the need for personal interaction.

Makous invokes the Golden Rule: “Over the course of my career, I learned to treat patients as I would like to be treated under similar circumstances.” (more…)

Posted in: Book & movie reviews, History

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NIH Awards $30 Million Research Dollars To Convicted Felons: Cliff’s Notes Version

In case you’re coming late to this discussion (or have ADD), I’ve summarized Dr. Kimball Atwood’s terrific analysis of the ongoing clinical trial (TACT trial) in which convicted felons were awarded $30 million by the NIH.

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In one of the most unethical clinical trial debacles of our time, the NIH approved a research study (called the TACT Trial – Trial to Assess Chelation Therapy – a supposed treatment for arteriosclerosis) in which the treatment had no evidence for potential benefit, and clear evidence of potential harm – and even the risk of death. Amazingly, the researchers neglected to mention this risk in their informed consent document. The NIH awarded $30 million of our tax dollars to ~100 researchers to enroll 2000 patients in this risky study (ongoing from 2003-present). Even more astounding is the fact that several of the researchers have been disciplined for substandard practices by state medical boards; several have been involved in insurance fraud; at least 3 are convicted felons.

But wait, there’s more.

The treatment under investigation, IV injection of Na2EDTA, is specifically contraindicated for “generalized arteriosclerosis” by the FDA. There have been over 30 reported cases of accidental death caused by the administration of this drug – and prior to the TACT, 4 RCTs and several substudies of chelation for either CAD or PVD, involving 285 subjects, had been reported. None found chelation superior to placebo.

So, Why Was This Study Approved?

The NIH and the TACT principal investigator (PI) argued that there was a substantial demand for chelation, creating a “public health imperative” to perform a large trial as soon as possible. In reality, the number of people using the therapy was only a small fraction of what the PI reported.

It’s hard to know exactly what happened “behind the scenes” to pressure NIH to go forward with the study – however a few things are clear: 1) the National Heart, Lung, and Blood Institute (NHLBI) initially declined to approve the study based on lack of scientific merit 2) congressman Dan Burton and at least one of his staffers (Beth Clay) and a lobbyist (Bill Chatfield) worked tirelessly to get the study approved through a different institute – NCCAM 3) some of the evidence used to support the trial was falsified (The RFA cited several articles by Edward McDonagh, the chelationist who had previously admitted in a court of law to having falsified his data.) 4) The NIH Special Emphasis Panel that approved the TACT protocol included L. Terry Chappell, whom the protocol had named as a participant in the TACT.

All evidence seems to suggest that political meddling managed to trump science in this case – putting the lives of 2000 study subjects at risk, without any likely benefit to them or medicine.

A formal analysis of the sordid history and ethical violations of the TACT trial was published by the Medscape Journal of Medicine on May 13, 2008. Atwood et al. provide a rigorous, 9-part commentary with 326 references in review of the case. Congressman Burton’s staffer, Beth Clay, published what is essentially a character assassination of Dr. Atwood in response.

The NIH Writes TACT Investigators a Strongly Worded Letter

On May 27, 2009 the Office for Human Research Protections Committee sent a letter to the investigators of TACT, stating that they found, “multiple instances of substandard practices, insurance fraud, and felony activity on the part of the investigators.” The letter describes a list of irregularities and recommends various changes to the research protocol.

It is almost unheard of for a letter from the NIH to state that research study investigators are guilty of fraud and felony activity – but what I don’t understand is why they haven’t shut down the study. Perhaps this is their first step towards that goal? Let’s hope so.

Conclusion

The TACT trial has subjected 2000 unwary subjects and $30 million of public money to an unethical trial of a dubious treatment that, had it been accurately represented and judged by the usual criteria, would certainly have been disqualified. Political meddling in health and medical affairs is dangerous business, and must be opposed as strongly as possible. Congressmen like Tom Harkin and Dan Burton should not be allowed to push their political agendas and requests for publicly funded pseudoscience on the NIH. I can only hope that the new NIH director will have the courage to fend off demands for unethical trials from political appointees.

Posted in: Clinical Trials, Health Fraud, Medical Ethics, Politics and Regulation, Science and Medicine

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Statins Are Better on JUPITER

Over 26 million Americans are taking statin drugs. Some people think they should be available over-the-counter without a prescription, and it has even been facetiously suggested that they should be added to our drinking water. The protective effect of statins in cardiovascular disease and in high-risk patients with high cholesterol levels is well established. But what about people with no heart disease and normal cholesterol levels – can they benefit too?

The New England Journal of Medicine has pre-released an important new study on statins online prior to its planned publication date of November 20, 2008. It is certain to stir up a lot of controversy, and the International Network of Cholesterol Skeptics will not be happy, because it contradicts some of their favorite arguments. They have claimed that statins do more harm than good, that reducing cholesterol levels is harmful to health, that the benefits of statins and/or cholesterol lowering do not extend to women and the elderly, and that studies showing benefits of statins are meaningless because they do not show reduction of overall mortality. This study indicates otherwise. (more…)

Posted in: Clinical Trials, Pharmaceuticals

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Are Cardiologists Ordering Too Many CT Angiograms?

A really snazzy new invention allows doctors to see inside their patients’ hearts as never before: the CT angiogram. It produces gorgeous 3-D video images of the beating heart in action. It allows us to see the blood flow through the heart’s chambers and it shows any plaque in the coronary arteries. Cardiologists are understandably excited about this new tool. Too excited. Some of them are using it indiscriminately and are getting half their income from using it.

On June 29, 2008 the New York Times published an excellent article entitled “Weighing the Costs of a CT Scan’s Look Inside the Heart.” A commenter on this blog has quoted from that article to criticize scientific medicine, and it brings up some important points that deserve a closer look.

With any new technology, the important question is whether it really improves patient outcome or just increases the cost of healthcare. These scans are a huge improvement for visualizing the heart. But are they any better than older diagnostic methods at actually preventing heart attacks or prolonging life? We don’t know yet. Will they cause harm through over-diagnosis? We don’t know yet. Will they cause radiation-induced cancers? We think they might. What’s the risk/benefit ratio? We don’t know yet.

Oprah thinks she knows. She’s urging her viewers to get tested. But she may not be the best source of medical advice. (more…)

Posted in: Science and Medicine

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