A potential new treatment for type 2 diabetes, dapagliflozin, recently failed to gain approval from the FDA. What makes this rejection noteworthy is that the new medication works by a completely new mechanism causing the kidney to excrete sugar from the blood into the urine. Reasons for the rejection were the increased risk of bladde and breast cancer in those taking the medication, increased urine and genital infections and possible liver toxicity. That list of problems seems pretty convincing to me. This is unfortunate because the drug appears to cause weight loss and does not cause low blood sugar (hypoglycemia). However, a drug that works by “poisoning” the kidney so that it dumps sugar into the urine strikes me as a drug that is going to cause a lot of other problems.
The other established diabetes medication generating new warnings is Actos (pioglitazone). I have written a number of articles on the sister drug Avandia, defending its usefulness despite possible cardiovascular risks, but the cancer warning for Actos is a new angle on this class of drugs (thiazolidinediones). Actos has been withdrawn in France due to concerns that it may cause bladder cancer but no such action has been taken in the U.S. The FDA this month did issue a warning that individuals with bladder cancer or at risk for bladder cancer, should be advised not to use Actos. If Actos is hit hard by these actions this whole class of diabetes drugs will have been eliminated from use.
A sure sign of trouble for Actos is that a “google search” for Actos is now showing lawyer websites as the first 5 citations.
Being sick is dangerous. Treating illness also has dangers. I am concerned that our cultural zeal for uncovering scandals and for pursuing litigation will lead us to sterile treatment options and doctors who are unwilling to risk helping.
Gary Pepper, M.D.
Editor in Chief, metabolism.com
Michelle shares her success story with T3. Michelle’s story demonstrates how combination therapy with T4 and T3 can be clinically superior to T4 (Synthroid, Levothyroxine) alone. In her story she mentions Wilson’s syndrome which I personally think is a “made up” diagnosis to help Dr. Wilson’s retirement fund but I do think her experience is fairly typical of a lot of people with hypothyroidism who eventually discover they need T3 added to conventional treatment with T4 to achieve best results.
OMG! Maybe I’m not crazy after all!
I’m 47 in December and can’t remember the last time I felt good or even okay. Same thing – doctors repeating same tests, thinking I’m exaggerating, sent to Psychiatrist…Over the past 6 years or so, major stress, low immune (sick all the time), worsening depression, borderline diabetes, high blood pressure, peri-menopause. Got to the point that I’m sooo exhausted. Don’t want to do anything. Lab diagnosis finally showed up hypothyroidism so doctor put me on Synthroid – I was so happy that I cried. Devastation set in after 6 months as this was not the miracle I thought it would be.
Started taking my temperature 3 to 4 x a day as suggested to me by a naturopath I had seen but couldn’t afford to keep going to. Again, measurements taken 3 x daily for a week averaged to 97.0. Talked to doctor about Wilson’s Temperature Syndrome; she did not believe in it and sent me for more blood tests which came back normal.
FINALLY (after 20 years at same doctor’s office) was lucky enough to be accepted under the care of a physician who hadn’t heard of WTS but had heard about the T4 not converting into the T3 (you all know the fault in the system)… so right then and there wrote me a prescription for Cytomel and told me to stop the synthroid. As the WTS website recommends sustained T3, I’m taking half the dose every 12 hours.
I started today and feel like a kid on Christmas Eve a million times over! I am so hopeful that this can get to the root of so many ailments. So many that I feel that I’m not even living my life, that I’m just here putting in everything I have just to get through the day.
With the lack of memory and concentration I have right now, I hope I remember to come back to this site and update you all!
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.
Gary Pepper, M.D.
Dael is taking a lonely path as a confirmed smoker. So far the benefits seem to out weigh the risks, but we all know what the end of this road will look like. I am posting Dael’s comments to see if the community at metabolism.com can make a positive impact on Dael’s rebellious attitude.
hey guys and gals just to let you know,
am down to 130lbs and feeling fit as a fiddle. have the 6 pack and abs i dreamed of and am fitter than i have ever been.. it really is odd cos i hate smoking but here i am having lost 42 lbs and loving every second of it apart from the smoking. what can i say – maybe rather die skinny and liking myself, than a fatty with some self righteous notion of how wonderful i am for not smoking… i hated myself with the extra weight, sorry but true…. i really can’t give a f***k for what anyone thinks on here but at least i can bear to look at myself in a mirror and like what i see, not loathe what i look like and try to bullshit myself into believing that i am sooooo happy cos i gave up the cigs….. but next is the NRT – lets see what happens there, and b4 anyone says it, yes i lost two of my best friends to cancer, of the spine and brain, but all i can say is like james dean , i’d rather live fast and furious, that be fat and dumb til 101, you can all choose, but in the end what do you all want?
i do not advocate smoking !!!
I know who i am
Ads on TV and in magazines are promoting weight loss programs specifically designed for diabetics. Weight loss is crucial to successful treatment of type 2 (adult onset) diabetes and is a highly desirable goal. In practice however, weight loss diets for diabetics can be dangerous if not properly supervised. Many adult diabetics are taking powerful medications to lower their blood sugars. These medications can work through several different mechanisms in the body, some of which can lead to hypoglycemia which is abnormally low blood sugar. Hypoglycemia may occur almost without warning resulting in rapid heart beating, sweating, confusion , poor coordination and even unconsciousness. When a diabetic begins a weight loss program, if their medication is not adjusted appropriately the risk of hypoglycemia goes up dramatically.
Most of the weight loss programs being advertised are designed by professionals but administered by non-medical personnel. Although their over-all goal is a good one, it seems to me that these programs are putting people at risk and are equivalent to engaging in practicing medicine without a license. It is careless to assume that the dieter’s doctor will be in a position to immediately make accurate medication adjustments when the diet begins.
Have you ever come across ads from lawyers soliciting clients who have been injured by products, including prescription medications? My thought is that soon these lawyers will be soliciting business from people who developed hypoglycemia on commercial diabetic weight loss programs, resulting in injury to themselves or others.
Gary Pepper, M.D.
As a culture we don’t plan for a sudden halt in scientific advancements. Our tendency is to expect progress to be rapid and continuous. My prediction is that in certain areas of medical science we are likely to see not only a halt in progress but a slipping backward. In particular, the realm of medical weight management is in complete disarray at this time. Two new drugs designed to induce weight loss have been shot down by the FDA in the last few months. The first is Qnexa, developed by Vivus Inc. Interestingly, Qnexa combines two drugs already approved for use in the U.S. One of the drugs is phentermine which is a medication used for decades as an appetite suppressant. The other is a common drug used to treat seizures with the brand name Topamax (topiramate) which also induces weight loss. The drug performed admirably in clinical trials with most participants losing over 10% of body mass. The FDA cited excessive risks of the drug in its statement of rejection. One wonders why the drugs are still being marketed separately if they are so dangerous.
The latest drug to be rejected by the FDA is Lorgess (lorcaserin), developed by Arena Pharmaceuticals. This drug, not as effective as Qnexa, produced 5% body mass loss in about half of participants in clinical trials. Lab animals showed a tendency to develop breast tumors when exposed to the medication, adding to the FDA’s decision to reject the drug application based on safety concerns.
I am a strong advocate of drug safety and regulation. On the other hand we know obesity, and with it Type 2 diabetes, is epidemic in the U.S. I regard weight loss as the “holy grail” when treating type 2 diabetes and yet it is the most difficult goal to achieve. Any drug which could assist in weight loss is highly desirable in the treatment of Type 2 diabetes. Not only does blood sugar improve with weight loss but also blood pressure and cholesterol readings show declines. All three of these parameters are known to be prime contributors to the main cause of death in diabetics, cardiovascular disease.
It has already been 10 years since the last drug was approved specifically for a weight loss indication. The failure of these two latest medications to achieve approval is certain to cause the pharmaceutical industry to severely curtail if not abandon further investment in this type of drug development.
Why is the FDA so reluctant to approve a weight loss pill? This is a complex issue but requires an answer. A new weight loss inducing medication is certain to be highly anticipated and widely prescribed. Therefore, from the very first day of approval the FDA must take responsibility for the well being of millions of people who are likely to take the medication. We are a society which demands our medications deliver miraculous cures with no side-effects. If someone perceives they have been injured by a medication our legal system is primed to unleash brutal retribution on everyone remotely involved in the approval process. Abuse and injury with a medication designed to cause weight loss is almost a certainty. This is a no-win situation for the administration of the FDA.
I predict it will be at least another 10 years before a medication for weight loss is approved by the FDA. Unless there is a change in the climate of litigation in this country it will take longer than that. In the meantime the only new developments in weight loss drugs will be the result of exploiting appetite suppressant effects which are the “side-effect” of medications approved for other purposes.
Gary Pepper, M.D.