Have you noticed that medication costs are skyrocketing? Even if you don’t take medication these higher costs are passed along to you in your health insurance premiums. The recently enacted Sunshine Act will combat these economic forces but in ways you may not realize. The legislation requires pharmaceutical companies to report all payments made to doctors. Physicians receiving substantial amounts of money from these companies include “thought leaders” who are sponsored by the drug companies to lecture the nation’s doctors on newly approved medications. (more…)
Early in May 2014 a patient being treated with Armour Thyroid (desiccated thyroid) for hypothyroidism reported that her pharmacy service would not refill her prescription for Armour Thyroid because it was an “illegal” drug. We were both very distressed to learn of this, but for different reasons. My patient was rightfully concerned that she might be receiving a wildly inappropriate medication, while I was concerned that I might not be able to prescribe a medication I knew to be extremely helpful and safe. (more…)
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.
A few days ago I was concluding a visit with a patient with thyroid disease, while her diabetic
husband, also my patient, looked on. They are a pleasant older couple I have known for
years, who are devotedly helping each other stay healthy. As they were leaving the exam room the
wife apologetically turned the subject to her husband mentioning he was having almost
daily “episodes†of weakness and confusion. “I hadn’t changed his diabetic medication recently
so why should his blood sugar be an problem now”, I thought. A number of other unpleasant
possibilities immediately occurred to me. I inquired about signs of a possible stroke or heart
condition. If these other angles were unproductive I faced the choice of sending him to the
hospital for an evaluation. We quickly ran through a routine systems review. He had lost 10
lbs in the past month, the wife mentioned. “Oh, no, cancer†, was my first thought. His wife
explained that as a New Year’s resolution he enrolled in a commercial weight loss program for
diabetics. With relief, I knew we had the explanation of his disturbing new symptoms.
Most of my diabetic patients are on medication since they are unable to maintain good glucose
control with diet and exercise only. If they succeed however, in achieving weight loss then the
diabetes medication must be reduced to prevent undesirable hypoglycemia (low blood sugar).
Hypoglycemia is potentially dangerous because the brain cannot function properly resulting in
abnormal behavior, loss of muscle control and even unconsciousness. Imagine this occurring
while behind the wheel? Down here in Florida this is all too common.
Many commercial weight loss programs have started targeting Type 2 diabetics (adult onset)
with their TV ads. These programs are generally administered by people without any medical
background. They cannot advise medication changes (not that you would want them to) without
breaking the law by practicing medicine without a license. The result, as with my patient, is the
development of potentially serious complications of hypoglycemia.
In a previous blog https://www.metabolism.com/2010/10/17/injured-diabetic-diet , I worried that this type of problem could develop with commercial weight loss programs. I didn’t expect to see evidence of it so soon and in my own exam room. If my patient’s wife didn’t stop and mention his new symptoms at the last moment
that day, I imagine a far worse outcome for her husband was possible.
The mission of the The Thyroid Project is to encourage sharing of information and experience between the public and the medical community about the treatment of hypothyroidism (low thyroid function). For at least the past few decades there is a growing awareness of “something missing†in the way suffers of hypothyroidism are treated for their disease.
Too many patients, as documented in an on-line study of 12,000 individuals conducted by the American Thyroid Association published in June 2018, (https://doi.org/10.1089/thy.2017.0681) , complain of persistent symptoms of hypothyroidism despite what their doctors believe is successful treatment with levothyroxine (brands include Synthroid, Unithroid, Tirosent, Levoxl). We believe something needs to be done to resolve this conflict between patients and their doctors.
Without effective intervention the early stage of type 2 diabetes known as prediabetes carries a high risk of progressing to outright diabetes. Metabolism.com provides an up-to-date summary of recommendations from national authorities, for preventing and possibly reversing this life long affliction
Diabetes can be defined simply as elevated blood sugar levels. What exactly is high blood sugar and when should someone be concerned about their level? Does having prediabetes mean diabetes is around the corner? Metabolism.com tackles this tricky but important topic in this comprehensive review.
By Gary M. Pepper, M.D. Ozempic, Rybelsus, Trulicity, Wegovy, Saxenda are the central players in the weight loss craze sweeping across the globe. Metabolisim.com has been monitoring this phenomenon from its beginnings in 2008 with its report “Lizard Spit Reduces Blood Sugar and Appetite”, regarding the first drug in this class, Byetta (exenatide). Caught In the middle of the current chaos are the medical experts who treat diabetes and have been prescribing these medications for more than a decade. Here is a brief commentary from one such board certified endocrinologist; “I started treating Type 2 diabetics with GLP-1 agonists more than 10 years ago. In some respects, these medications have revolutionized the treatment of diabetes by lowering blood sugar effectively and promoting weight loss at the same time, a unique combination of benefits. Not everyone benefits from these drugs to the same degree unfortunately, and I have seen lots of patients experience unacceptable side effects from them. Nothing though, has prepared me for what is happening now. Too often, I find myself confronting someone who expects me to prescribe one of these drugs just so they can lose weight. Sadly, one extreme example was someone who, despite battling a life threatening medical condition, was insistent on getting a prescription. At the same time my diabetic patients are scrambling to find a place to buy their medications if they can even afford it. It is disheartening, to say the least, and I dread the negative interactions with some of my patients I now face almost daily.”
Off- Label Use
The FDA is the U.S. government’s department tasked with evaluating and approving drugs for specific medical conditions. When a new medication is approved for treating a medical condition by the FDA the agency will, at the same time, set strict guidelines for exactly which patients may use the newly approved drug. When a medication is used “off-label” it means that these limitations are being overridden by the provider for a potential benefit which outweighs the drugs risks. It is a general misconception that off-label means illegal; it does not. This practice has been going on for ages and more than 20% of prescriptions in the United States are prescribed off-label. A common example is the use of beta-blockers (approved for heart problems) for the treatment of performance anxiety.
GLP-1 agonist drugs, as discussed recently by metabolism.com. were originally approved for the treatment of Type 2 diabetes in adults. In the past few years most of these same medications have gained unprecedented popularity for their “off-label” weight loss benefit. Of the 5 GLP-1 agents presently in U.S. pharmacies only Wegovy (semaglutide) and Saxenda (liraglutide) are FDA approved for treating obesity. Of these two, Wegovy is the newer and had been much more popular that its sister drug Saxenda, probably due to being dosed only once weekly compared to daily for Saxenda and less likely to cause side effects. Due to Wegovy’s soaring popularity, its manufacturer, Novo Nordisk, increased the price of Wegovy two times since its initial release.
