by Dr. G. Pepper | Sep 27, 2010 | diabetes, diet, diet and weight loss, fitness, general health & nutrition, health, metabolism, weight loss
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.
Editor-in-Chief, Metabolism.com
by Dr. G. Pepper | Feb 23, 2010 | diabetes, general health & nutrition, health, hormones, metabolism
In 2007 I published an article entitled, “Old News About Avandia and Actos Makes Front Page New York Times”. This article criticized the media for publishing an old story about the potential danger of Avandia, then a popular diabetes medication. Even in 2007 the potential hazard of Avandia was a story which had been beaten to death by experts with the conclusion that the hazard of using this drug was probably exaggerated by a few vocal critics. Since then much more information has come to light supportive of the safety of using Avandia. Just a week ago the whole issue again made front page news, making it seem as if something new had come to light on the safety issue. Close inspection of the reports show this to be virtually the same information that existed in 2007 without the benefit of more recent information, but now rehashed by a congressional committee. So here we have it…old, old news making headlines again but unenlightened by the passage of another 3 years.
Here is the original story about “old news” which I published at metabolism.com in 2007
Old News About Avandia and Actos Makes the Front Page NY Times
Today’s NY Times carries a front page article about the dangers of Actos and Avandia, two popular diabetes medications. The reason behind the news story is that the FDA has finally required the two companies that make these diabetes drugs to carry a “black box†warning (the strongest labeling warning that can be applied) about the potential for congestive heart failure (overload of fluid in the heart and lungs) in diabetics using these drugs. Is this warning really news? Not to doctors.
I have been to numerous seminars on the use of these two diabetes drugs and have been paid by the companies that manufacture these drugs to educate other health care professionals about the use and hazards of these drugs. Both companies gave all representatives and speakers the strictest instructions regarding their obligation to carefully mention the potential for fluid overload and congestive heart failure associated with the use of these drugs. I know that my colleagues, particularly the cardiologists (heart doctors) and endocrinologists (diabetes doctors), have been acutely aware of this information for years.
Did you know that the type of drugs known as sulfonylureas that have been used to treat diabetes since the 1960’s and remain popular today carry a “black box†warning since the 1970’s about the potential for causing heart disease? This class of drug include Diabinese, Orinase, DiaBeta, Micronase, glyburide, and glipizide. Why are these drugs still in widespread use, and where are the stories notifying the public about this? What’s the big deal about the black box warning on Actos and Avandia?
I think I smell some politics going on. The Commissioner of the FDA, Dr. von Eschenback, was appointed by President Bush in 2005. The harshest critics of the FDA on this issue are the Democrats on the House Panel. Coming out of the woodwork are various “injured†parties who were criticised by company representatives for speaking out against these drugs in 1999. These stories warrant a separate column in The Times today.
Are there real risks to taking Actos and Avandia in the treatment of diabetes. Of course there are, just as there is a real risk of treating diabetes with just about any drug. It is up to the medical profession to remain vigilant and educated about these risks and to balance them with the benefits. Inflammatory front page news stories which create an atmosphere of mistrust and hysteria may serve only narrow political purposes.
This blogged comment at metabolism.com is not intended to convey medical advice. Diabetics are encouraged to contact their own healthcare professional about advice about what to do at this time. Most authorities encourage the public not to panic and to wait instructions from their physician before altering their medical treatment.
by Dr. G. Pepper | Sep 7, 2009 | general health & nutrition, health, hormones, metabolism, misc, thyroid, Uncategorized, weight gain
Below, Mele describes her plight struggling to adjust to the disappearance of Armour from U.S. pharmacies. She discovered what was explained in my post, “Behind the Disappearance of Armour”. Forest Pharmaceuticals and Medicare are both responding in their own ways to the FDA decree that Armour Thyroid submit an application (NDA) as if it were any new drug seeking to come to market now. The FDA is charged with the responsibility to assure all prescription drugs in the U.S. demonstrate minimum levels of safety and efficacy. As a bureaucracy the FDA is unable (unwilling) to find a way to use the 50+ years of unblemished clinical experience unique to Armour, to satisfy this requirement. Rather than correct its own deficiency the FDA is forcing many thousands of hypothyroid patients on dessicated thyroid products to go through the difficult and potentially dangerous process of finding alternative thyroid hormone therapies. I am guessing that the FDA is receiving support for this policy from companies making synthetic t4 products and from medical organizations and their officers who receive funds from these same companies. Let’s not forget that Forest itself markets a generic t4 product, Levothroid, which will absorb some of the business lost by the withdrawal of Armour.
Mele submits her story to metabolism.com:
I’m just devastated. I could only get a seven day supply yesterday of Armour at Wal-Mart. They have no idea what the problem is and told me to come in Tuesday and they would have some again. I had no idea there was a problem again (last year’s nightmare made me assume everything would be ok after Forrest redid their manufacturinging plant) until I googled today.
I am 66 years old and have been on Armour Thyroid since I was 15 years old when I had a subtotal thyroidectomy for carcinoma. The only time I ever tried Synthroid was about 20 years ago when an endocrinologist convinced me that I was going to get osteoporosis if I continued using Armour. I only took it for two months, and when I walked into my family doctor’s office at the end of the two months, he took haveone look me and said “whWt is wrong? You are not youâ€. I wasn’t me anymore (and the blood tests he ordered confirmed that I was very low on T3 and barely in the normal range for T4). That was probably the most terrifying experience I have ever had. I had no idea how totally entwined my personality, and feelings of well being, are dependent on Armour. I still find it scary that “me†is a product of a drug I take and when I take a different brand, I am no longer me. I felt like a stranger in my own skin…weak, no sparkly, dramatic personality… instead dull feeling, acting and cobwebs in my brain. My family doctor said that he was putting me back on Armour immediately and slowly I began to feel like me again.
I’m terrified now. I am in the middle of trying to prepare for a very complicated (nothing is ever simple or easy medically for me) cataract surgery in another city that I have fly to repeatedly for the presurgical appointments. If I have to go on Synthyroid again…how can I deal with this other upcoming surgery? It can’t be put off as I can barely see to drive now.
Anyhow, I agree with others here that we have to organize and fight this. I find it very difficult to believe this is simply a shortage of the thyroid powder that Forrest is claiming is the problem. This is the FDA meddling, yet again, with patients very lives. I think I know an organization that will help us as they have fought bloody battles with the FDA for many years and have been victorious to a large extent. I am speaking of the Life Extension Foundation. I’ll be contacting them.
Two other things. For what it is worth, I have noticed no problems with the change in Armour but for the first time in many years, I have not done thyroid blood levels in two years. But I feel fine so I guess I don’t have the absorbtion problem some mention with the new formula. I have had hair breakage though which I have puzzled over and that could well be due to the formula change.
As for Medicare and Armour, I have had Medicare since a drunk driver hit me many years ago so I have had Medicare long before I turned 65. When Medicare Part D first appeared Armour was on the Medicare forumulary. That was in mid 2006. Armour was on the Medicare formulary in 2007 also. Beginning Jan 2008, Armour was removed from the Medicare formulary. My physician I did a lot of research, calling, letter writing, etc. about it. My drug plan was and still is from AARP/United Health Care. United Health Care is angry about the Armour situation. However, they cannot make a special exception to cover it when a physician asks them to do so (as mine did) because their hands are tied. They are required by law to allow ONLY drugs that are approved and on the Medicare formulary.
AARP/United Health Care covers ALL drugs on the Medicare formulary and by law cannot cover any that are banned from the Medicare formulary. Armour was banned in 2008. I called Forest about it and was extremely puzzled by their lacksidasical response. My physician wrote Forrest also and they sent back a reply that had nothing to do with the question about Armour being removed from the Medicare formulary. My physician learned later that his, and my, suspicions were correct. It was removed because the FDA told Medicare that they could not cover a drug that had not gone through the NDA I believe it is called…where a new drug has to undergo extensive clinical trials as per FDA regulations. We learned that the FDA was requiring Forrest to do this if they wanted Medicare coverage for Armour. Well, that is not possible. Forrest charges very little for Armour. Where are they supposed to get the money for the many years of clinical trials that the FDA has demanded? The FDA knew that demanding this would effectively kill Armour and that was their intent.
So, since Jan 2008, I have had to pay for a Medicare Part D plan that I can’t use because the only drug I take (unless I need an antibiotic or something short term) is Armour. Wat is worse, most health insurance companies follow the Medicare formulary so if Medicare no longer covers Armour then most insurance plans will not cover it either.
