FDA to Weight Loss Drug Developers: “Drop Dead!!”

In just the last few months the FDA shot down applications from three new weight loss drugs
and removed one from the market that was previously approved. A month ago, based on
analysis of these actions, I predicted it will take 10 years for a new weight loss drug to be
approved by the FDA
. The latest action by the FDA makes me more confident than ever, in this
prediction.

A sensational action by the FDA to cripple development of new weight loss drugs came
about two weeks ago. The FDA denied approval to the weight loss drug candidate Contrave,
a combination of two medications. Both of the drugs in the combination pill are presently in
use and were FDA approved decades ago for indications other then weight loss. One of the
drugs Naltrexone, is used to treat opiate drug overdoses and the other bupropion HCL is used
to treat depression. Given the long history of safety of both drugs it would seem surprising
the FDA would reject the combination of these drugs on grounds of safety concerns, which
was what happened. Making the FDA rejection even more astounding is that just a month
before, a majority of members of the FDA’s own Endocrinologic and Metabolic Drugs Advisory
Committee, gave a thumbs-up to Contrave. In almost all previous instances where the Advisory
Committee gives their green light to a new drug candidate, the FDA has followed through with
an approval. I can hardly imagine a clearer way for the FDA to say “Drop Dead!!” to all those
seeking to get approval for a new weight loss medication.

Michael Narachi, CEO of Orexigen the maker of Contrave, is quoted as saying he “was
surprised and extremely disappointed with the agency’s (FDA’s) request”, a request which
essentially ended any chance of getting approval for his company’s weight loss drug. My advice
Michael, is to move on with your company and find another drug class to work on. Maybe
something to smooth away skin wrinkles or relieve constipation. I’m sure you will have a lot
more success. In the meanwhile, the epidemic of diabetes type 2, cardiovascular disease, and
disabilities due to degenerative joint disease, all related to obesity, marches on.

A final note of advice to investors in the medical field. I would spend my money on a psychiatrist
before investing money in companies conducting research on weight loss medication, since you
won’t see a penny from your investment for ten plus years.

Gary Pepper, M.D.
Editor-in-Chief, Metabolism.com

How Light Effects Your Metabolism by Jim Rollince

A guest contributor, Jim Rollince, shares this informative article on how the amount of light in our environment can have a big impact on health.

Jim writes:

Ambient Light During Sleep and The Affect on Metabolism

By Jim Rollince of Gym Source, distributor of home gym equipment, including treadmills, ellipticals and other home gyms.

Frustrated that your exercise routine and constantly calorie counting has not yielded any weight loss results? Are you in fact gaining more weight then before you began exercising and monitoring your food consumption? The key to your weight gain could be a result of an external factor that you never took into account, the exposure to light at night.

New research in sleep science has shown that prolonged exposure to light during the regular nighttime sleeping hours may cause weight gain. This weight gain occurs independent of daytime calorie consumption and physical activity.

These research findings came out of a study by the Proceedings of the National Academy of Sciences. The study tested animals, and the findings have begun to raise discussion from the scientific community based on whether the human body experiences metabolic sluggishness and weight gain as a result of too much light exposure at night.

A research team from Ohio State University discovered that mice exposed to a dim light during the course of a night for roughly a two-month period, gained 50 percent more body mass than mice exposed to a regular light-dark cycle. “Although there were no differences in activity levels or daily consumption of food, the mice that lived with light at night were getting fatter than the others,” said Laura Fonken, a neuroscience doctoral student at Ohio State and director of the study.

Although the lab mice were exposed to nighttime light they did not become less active nor eat more. However, they did eat at times when they normally wouldn’t. In fact, in one part of the study when the mice were exposed to light at night and then restricted from eating with the exception of their normal feeding times, they did not experience more weight gain.

“Something about light at night was making the mice in our study want to eat at the wrong times to properly metabolize their food,” Randy Nelson, professor of neuroscience and psychology at Ohio State and co-author of the study.

The researchers found that levels of the stress hormone corticosterone were not different among the mice exposed to the dim light and mice exposed to standard light-dark. This finding was surprising for the research team since corticosterone is connected to changes in metabolism. The research has shown that changes in metabolism have the potential to cause weight gain independent of corticosterone levels.

What is the link between dim light at night and fat-causing changes in one’s metabolism? The Ohio State research team postulates that the presence of light during the night works to disrupt hormone melatonin. Hormone melatonin plays a significant role in the functioning of the metabolism. To this end, light exposure at night could in fact disrupt expression of clock genes, which aid in controlling the time animals choose to be active and eat.

Dr. Nelson furthers her comments by saying that if her team’s research results are confirmed, eating late at night is a serious contributing factor to obesity. “Light at night is an environmental factor that may be contributing to the obesity epidemic in ways that people don’t expect,” he said. “Societal obesity is correlated with a number of factors including the extent of light exposure at night.”

Past research similar to this study have been prolonged television and computer use as contributing risk factors for obesity. Yet these studies were centered in the idea that engaging in prolonged television or computer usage contributed to a lack of physical activity. The current connection between weight gain and the light coming from a TV or computer, is related to the disruption of the metabolism via the negative bodily effects of getting too much light exposure at night and eating at the wrong time.

“Clearly, maintaining body weight requires keeping caloric intake low and physical activity high, but this environmental factor may explain why some people who maintain good energy balance still gain weight,” Dr. Nelson’s press statement.

Adopted Children Experience Early Sexual Maturity

Puberty occurs when areas within the brain awaken beginning a cascade of hormone signals which conclude with the gonads (ovaries and testicles) increasing their production of the female and male sex hormones estrogen and testosterone. Under the influence of these hormones a child begins the transition from childhood to sexual maturity. In boys puberty is associated with a growth spurt, the appearance of facial, axillary (arm pit) and pubic hair, acne, deepening of the voice, growth of the testicles and penis while girls undergo a growth spurt, develop breasts, acne, pubic and axillary hair, and growth of the clitoris.

Historical data shows the average age of puberty today is many years sooner than in previous generations. Most experts attribute earlier puberty to better nutrition. A recent article in metabolism.com reviewed how “over-nutrition” accelerates obese children into puberty sooner (referred to as precocious puberty) than normal weight children. The latest studies on causes of precocious puberty suggests that a child’s social environment also exerts an important influence on the timing of puberty. Researchers in Madrid publishing in The Journal of Clinical Endocrinology and Metabolism 95:4305 2010 analyzed the age of puberty in normal children, adopted children and children whose families immigrated (children not adopted but subject to high levels of personal stress) to Spain. Adopted children were 25 times more likely than other groups of children to undergo precocious puberty (breast development before the age of 8 years in girls, and boys under 9 years of age with testicular growth). Over-all girls were 11 times more likely than boys to demonstrate precocious puberty.

Researchers speculate that socio-emotional stresses early in life of children who are later adopted result in changes in the brain that cause premature maturation of vital nerve pathways. This early brain maturation later results in stimulation of the pituitary gland, turning on the hormone pathways that cause puberty. This seems strange to me because various forms of deprivation in childhood can also delay puberty. For example, girls who have anorexia remain child-like in their body development and may fail to menstruate even into their late teens. A decade ago I studied hormone levels in adults during the stress of illness and surgery and found this lowered the sex hormone levels in their blood. This makes sense from an evolutionary point of view because during stressful conditions nature wisely cuts off the reproductive hormones. Why make babies if the environment is hostile in some way? Why the opposite occurs in children under stress of adoption is an interesting but unanswered question.

Gary Pepper, M.D.,
Editor-in-Chief, metabolism.com

Chubby Neck Becomes the New Normal

After reading the latest research on the metabolic hazards associated with chubby necks I am more sensitive to the size of people’s necks then ever. Of course I look at the size of my patient’s neck but people who I pass in the street or supermarket may find me staring. Watching TV a few days ago I was startled by a series of people in one commercial for Quicken Loans who definitely qualify for the metabolic high risk category based on neck chubbiness. One after another the characters in this commercial walk on, outdoing each other in this physical trait. Has the chubby neck become the new normal? If so, the incidence of diabetes and heart disease is sure to continue to rise.

Let me know if you agree with my impression, or am I biased by being an endocrinologist?

Gary Pepper, M.D.
Editor-in-chief, Metabolism.com

Large Neck Size Equals Big Metabolic Problems

Large Neck Size Equals Big Metabolic Problems:

A bulging stomach is widely accepted as a sign of poor metabolic health. A recent study published in the August Clinical Endocrinology and Metabolism (95:3701, 2010), finds a chubby neck is likely to hold even a worse prognosis for metabolic health.

The research team evaluated the relationship between waist circumference and neck circumference with levels of blood sugar, good cholesterol (HDL), bad cholesterol (LDL), triglycerides, and insulin resistance, as well as blood pressure. What was found was that neck circumference was a better predictor than waist circumference of elevated blood pressure, LDL, triglycerides and insulin resistance, with lower levels of HDL. All this amounts to a greater risk of cardiovascular disease as neck size increases. As an example, an increase in neck circumference of about one inch is expected to result in a 2.5 point rise in blood pressure.

The authors point out that the neck circumference was a more accurate predictor of cardiovascular risk in women than men. The average neck size for men in this study was about 16 inches (40.5 cm) and about 13.7 inches for women (34 cm).

Alfred Hitchcock, the famous director of suspense movies, made a trademark of his corpulent silhouette with bulging chin and abdomen. Thanks to this research we know his silhouette can signify more than a movie that will thrill you but also a metabolism that will kill you.

Gary Pepper, M.D.
Editor-in-Chief, Metabolism.com

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