January 1st, 2012 by HarvardHealth in News
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Why would a pediatrician draw blood from your 9-, 10-, or 11-year-old at his or her next annual wellness visit? Because the American Academy of Pediatrics (AAP) recently endorsed updated guidelines that call for checking LDL (bad) cholesterol levels in all kids between the ages of 9 and 11.
The cholesterol-test recommendation created quite a stir. But wait, there’s more. The guidelines also call for annual blood pressure checks beginning at age 3, and periodic blood sugar measurements starting between ages 9 to 11. There’s also a strong recommendation for kids and adolescents to limit sedentary screen time to two hours or less per day, and to get at least an hour a day of moderate physical activity.
The biological basis for these guidelines is that atherosclerosis (the fatty gunk in arteries that causes heart attacks, strokes, and other serious problems) starts during youth. In many cases, Read more »
*This blog post was originally published at Harvard Health Blog*
May 28th, 2010 by Toni Brayer, M.D. in Better Health Network, Health Tips, Research
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The British Medical Journal reported on a study of toothbrushing and found that people with poor oral hygiene had an increased risk of cardiovascular disease and heart attack.
We’ve known for the last two decades that inflammation plays an important role in atherosclerosis. Markers of low-grade inflammation like C-reactive protein are also shown to be higher in heart disease.
The Scottish Health researchers looked at the general population and followed a large subset with questions about their oral health. They asked about frequency of dentist visits, toothbrushing, and controlled for many co-variables such as general activity, hypertension, smoking, height and weight. They also collected blood for studies of C-reactive protein as a marker of inflammation. They removed from the analysis participants who had no natural teeth (edentulous) and those with existing cardiovascular disease.
This elaborate and lengthy study showed that toothbrushing is associated with cardiovascular disease, and that subjects who brushed their teeth less than once a day had a 70 percent increase in heart disease compared with people who brushed twice a day. The inflammation that periodontal disease causes is directly related to increased C-reactive protein and increased heart attacks.
Leave it to the Scotts and the Brits to remind us to brush and floss every day.
REFERENCE: British Medical Journal, 2010; 340: c2451.
*This blog post was originally published at EverythingHealth*
July 3rd, 2009 by Dr. Val Jones in Quackery Exposed
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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.
