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Monthly Archives: December 2016

Medical Guideline Panels Have Conflicts

More than half of panel members who gather to write clinical practice guidelines on diabetes and high cholesterol have conflicts of interest, new research suggests.

“The concern is that compensation by industry on some of these panels can pose a potential risk of industry influence on the guideline recommendations,” said Dr. Jennifer Neuman, lead author of a paper published online Oct. 11 in the BMJ.

Clinical practice guidelines are meant to direct health care professionals on how to best care for patients.

In the United States and Canada, most organizations (including nonprofit and governmental bodies) have their own protocol for divulging conflicts of interest.

And recently, the Institute of Medicine (IOM) published recommendations on how organizations should manage conflicts of interest when drawing up guidelines. Among other things, the institute advocated excluding individuals with financial ties to thedrug industry.

The authors of this paper looked at conflicts of interest, both reported and unreported, among members of 14 different guideline panels in the United States and Canada over the past decade. They focused on two categories only: high cholesterol and diabetes, which account for a lion’s share of drug expenditures.

Organizations included the American Heart Association, the American Diabetes Association and the U.S. Preventive Services Task Force (USPSTF).

Five of the organizations did not require conflict-of-interest disclosures from panel members, the investigators found.

Among a total of 288 panel members, conflicts of interest were found among 52 percent, overall.

And 11 percent of those who claimed no conflicts actually did have conflicts, though, to be fair, Neuman said, most fell within the range of their particular organization’s cut-off point for declaration, albeit not within the cut-off established by these authors.

In addition, half of panel chairs had conflicts, the authors said.

On the other hand, only 16 percent of panel members from government-sponsored guidelines such as the USPSTF declared conflicts, versus 69 percent of non-governmental entities.

The authors noted that unless a particular journal publishing guidelines requires it, USPSTF divulges conflicts of interest only after a Freedom of Information Act request has been filed.

“The difference between the degree of conflict found on government and non-government panels was very surprising to us,” said Neuman, who is an instructor of preventive medicine at the Mount Sinai School of Medicine in New York City. “It is possible to convene guideline panels that do not have very much conflict.”

In a written comment, the American Heart Association stated that the association “has long had strict policies for preventing any undue influence of industry. In 2010, we refined our policies to require even more stringent management of relationships with industry, to align with the Council of Medical Specialty Societies. Thus, the conclusions drawn by the British Medical Journal article do not reflect the reality of the guidelines development process today, when, for example, all Chairs of our guideline writing groups are free of relationships with industry and we assure that more than 50 percent of each writing group are also free of such relationships. . . . The association believes that our policies control the potential for inappropriate bias to influence guidelines development.”

Dr. Sue Kirkman, senior vice president of medical affairs and community information at the American Diabetes Association, said that the association was “moving towards meeting the standards in the IOM report.” One of the changes it’s making is to try to weed out people with conflicts before appointing them to a panel. The current guidelines, though, she added, are in the best medical interest.

“In general, most people on guideline panels are interested in doing the right thing and promoting evidence-based data but it’s really important to follow . . . recommendations from the IOM towards increased transparency to prevent any potential biases from coming in,” Neuman said.

Health Hypnosis’s Benefits

Today is World Hypnotism Day, and according to the official website, its mission is to “remove the myths and misconceptions while promoting the truth and benefits of hypnotism to the people of the world.” There are certainly many of those misconceptions around, largely due to movies and TV shows that depict eyes following a swinging watch, or people called up on stage who get suckered into acting like clucking chickens or barking dogs. But proponents say it’s time to forget those old stereotypes — whether it’s called hypnosis, hypnotism, or hypnotherapy, this practice is actually an effective, drug-free way to promote behavioral change.

What is hypnosis, anyway? According to the American Society of Clinical Hypnosis, it is a tool that allows the mind to focus — similar to how a magnifying glass focuses and intensifies the sun’s rays. Unlike the popular myths, you’re not actually unconscious while in a hypnotic state, but fully awake and in a heightened state of concentration. There are several different ways that practitioners can help individuals who are under hypnosis: They may present ideas or suggestions, encourage patients to come up with mental images that illustrate positive change, or help them better understand their underlying motivations.

Need more convincing? Hypnosis is also recognized as a valid medical procedure by the American Medical Association and the American Psychological Association. If you’re curious, here are just a few of the ways hypnosis can help your health:

Hypnosis for weight loss: Hypnosis can help people change their eating behaviors and drop the pounds. According to a Vanderbilt University review of the scientific literature, hypnosis works best for weight-loss when combined with a behavioral weight -management plan.

Hypnosis to quit smoking: At the 2011 annual meeting of the American Psychiatric Association, Jose Maldonado, MD, associate professor of psychiatry at Stanford University, reported that the success rate of hypnosis for smoking cessation may be as high as 64 percent.

Hypnosis for depression: Cognitive hypnotherapy, which combines hypnosis with cognitive-behavioral therapy, helps change unwanted patterns and behaviors by connecting with the subconscious mind. Experts say this treatment can help the “stuck” thought patterns that go along with depression, anxiety, OCD, and other mood disorders.

Hypnosis for pain management: Hypnosis has been used to treat both chronic types of pain (arthritis, fibromyalgia, irritable bowel syndrome) and pain resulting from serious injury. A study published in the International Journal of Clinical and Experimental Hypnotism found that hypnosis using virtual reality software reduced the intensity of pain in hospitalized trauma patients more than standard treatment alone.

Low level vitamin D during remission contributes to relapse

Lower vitamin D levels have been associated with active disease in patients with UC, but it has been unknown whether they increase disease relapses. “Prior studies in patients with Crohn’s disease and Ulcerative Colitis had linked low vitamin D levels to disease flare-ups,” said senior author Alan Moss, MD, a gastroenterologist at the Digestive Disease Center at BIDMC and Associate Professor of Medicine at Harvard Medical School.

“However, it has been unclear if the flare-up was lowering vitamin D levels, or if low vitamin D levels were causing the flare-up. We thought that if we looked at vitamin D levels when the disease was inactive and then followed patients moving forward, the impact of baseline vitamin D levels on future events may be clearer.”

Moss and colleagues collected vitamin D serum levels through a physician-blinded prospective study of 70 patients with UC in clinical remission who were followed up after a surveillance colonoscopy at BIDMC. The study measured vitamin D levels in blood samples and levels of inflammation through blood tests and biopsies. The researchers then followed the patients for 12 months and compared the data from participating patients who remained well and the others who experienced relapses. The investigators found the mean baseline vitamin D level to be lower in patients who later relapsed than those who did not.

“Patients who had higher vitamin D levels when their disease was in remission were less likely to experience a relapse in the future,” said John Gubatan, MD, a physician at BIDMC and first author of the study. “This suggests that higher vitamin D levels may play some role in preventing the UC relapse.” The threshold level of blood vitamin D that was protective was greater than 35ng/ml, which is within the range recommended by the National Institutes of Health for a healthy individual.

Ongoing work by Gubatan and Moss is now examining the link between vitamin D and a protein called cathelicidin in the cells lining the colon. The link may have beneficial effects on microbial composition, an important component of a healthy colon. Building on this research, investigators are trying to unravel how vitamin D may protect cells in the colon and the microbial composition of the bacteria, fungi, protozoa and viruses that live on and inside the human body, Moss noted.

Second cause of hidden hearing

Now, less than six years since its initial description, scientists have made great strides in understanding what hidden hearing loss is and what causes it. In research published in Nature Communications, University of Michigan researchers report a new unexpected cause for this auditory neuropathy, a step toward the eventual work to identify treatments.

“If people can have hidden hearing loss for different reasons, having the ability to make the right diagnosis of the pathogenesis will be critical,” says author Gabriel Corfas, Ph.D., director of the Kresge Hearing Research Institute at Michigan Medicine’s Department of Otolaryngology — Head and Neck Surgery.

Corfas published the research with co-author Guoqiang Wan, now with Nanjing University in China. They discovered using mice that disruption in the Schwann cells that make myelin, which insulates the neuronal axons in the ear, leads to hidden hearing loss. This means hidden hearing loss could be behind auditory deficits seen in acute demyelinating disorders such as Guillain-Barré syndrome, which can be caused by Zika virus.

Corfas and Wan used genetic tools to induce loss of myelin in the auditory nerve of mice, modeling Guillain-Barré. Although the myelin regenerated in a few weeks, the mice developed a permanent hidden hearing loss. Even after the myelin regenerated, damage to a nerve structure called the heminode remained.

Synapse loss versus myelin disruption

When the ear is exposed to loud noises over time, synapses connecting hair cells with the neurons in the inner ear are lost. This loss of synapses has previously been shown as a mechanism leading to hidden hearing loss.

In an audiologist’s quiet testing room, only a few synapses are needed to pick up sounds. But in a noisy environment, the ear must activate specific synapses. If they aren’t all there, it’s difficult for people to make sense of the noise or words around them. That is hidden hearing loss, Corfas says.

“Exposure to noise is increasing in our society, and children are exposing themselves to high levels of noise very early in life,” Corfas says. “It’s clear that being exposed to high levels of sound might contribute to increases in hidden hearing loss.”

The newly identified cause — deficiency in Schwann cells — could occur in individuals who have already had noise exposure-driven hidden hearing loss as well. “Both forms of hidden hearing loss, noise exposure and loss of myelin, can occur in the same individual for an additive effect,” Corfas says.

Previously, Corfas’ group succeeded in regenerating synapses in mice with hidden hearing loss, providing a path to explore for potential treatment.

While continuing this work, Corfas started to investigate other cells in the ear, which led to uncovering the new mechanism.

There are no current treatments for hidden hearing loss. But as understanding of the condition improves, the goal is for the research to lead to the development of drugs to treat it.

“Our findings should influence the way hidden hearing loss is diagnosed and drive the future of clinical trials searching for a treatment,” Corfas says. “The first step is to know whether a person’s hidden hearing loss is due to synapse loss or myelin/heminode damage.”