by Gary Pepper M.D. | Jan 16, 2023 | NUTRITIONAL-HEALTH
by Gary M. Pepper, M.D. and Sam Jeans, MSc The global anti-obesity drug market, in 2021was valued at over $2 billion. Within one year this figure had skyrocketed to $8 billion and is expected to climb to nearly $ 20 billion by 2027. This astounding growth is a reflection of soaring obesity rates, and the arrival of a new class of weight loss medication fueling a craze both in the USA and across the world.
The FDA and global health regulators, until very recently, had maintained a very tight ship when it comes to treating obesity with medication, placing the emphasis on diet and exercise rather than weight loss drugs. Since the 80s, anti-obesity drugs continued to be controversial, and a more stringent FDA implemented ongoing safety trials along with other precautions. There is some speculation that a shift in attitude toward approval of weight loss medication by the FDA , is underway
Weight loss drug controversies are far from over and, in fact, may soon rival the amphetamine crisis of the 70’s. For that reason, metabolism.com has felt it important to provide our guide to weight loss drug issues, past and present.
Anti-Obesity Drugs Timeline
Prescription drugs for lifestyle diseases such as obesity were marketed heavily throughout the 1950s to the 1970s. Amphetamines entered the public domain after the Second World War where they were used extensively in the military.
In the 50s, walk-in clinics prescribed diet pills with other medications almost at random, with or without genuine concern for one’s weight. These brightly colored pills became known as “rainbow pills”.
In the 1960s and 1970s, the so-called “rainbow pill diet” of pills was finally coming to an end as the FDA began to systematically ban many of the drugs involved. A high-profile expose by investigative journalist Susanna Mcbee, published in Life magazine, brought attention to this new modern public health crisis.
The rainbow pill diet combined amphetamines, laxatives, thyroid hormones, and even diuretics to produce extreme weight loss, combined with benzodiazepines, barbiturates, and steroids to reduce side effects, and antidepressants to suppress medication-induced insomnia and anxiety.
In 1968, rainbow pills were linked to over 60 deaths, with numerous accounts of their devastating impact surfacing in the news and media. Within just two months, 48 million pills were seized and destroyed. Nevertheless, amphetamine-based diet pills remained extremely popular throughout the 1970s. In 1978, some 3.3 million prescriptions for amphetamines were written each year, with some 50 million pills a year ending up in the black market.
In 1979, the FDA banned amphetamines as a weight loss aid, but that is hardly the end of the USA’s love affair with obesity medication.
Here’s a brief timeline of recent anti-obesity drugs:
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by Dr. G. Pepper | Dec 23, 2009 | diet and weight loss, general health & nutrition, health, hormones, metabolism, thyroid
Hank Frier has been involved with the pharma industry for a long time and helps us see through the news blackout in regards to the FDA actions on Armour. He is also suffering the same fate as many others in the U.S., having been successfully treated with Armour for many years, now forced to switch to other alternatives.
Hank writes:
I too have been switched back to Synthroid after several successful years of being on Armour. At this juncture it is too early to tell how this will impact me. Luckily, my physician had the foresight to also put me on Cytomel after I suggested this from my readings. The combination of Armour and Cytomel seemed to work quite well for me without any adverse events.
This next is my opinion so take it as such. I believe the makers of Synthroid (Abbott Ross) in an attempt to increase their sales of Synthroid put pressure on the FDA to require the makers of Armour to submit an NDA. It is a devastatingly poor tactic by Abbott Ross but typical of this industry.
It is unfortunate that the FDA is caught in the middle of this since by statute and law drugs must pass regulatory muster. Where the FDA has failed is in their lack of looking at the long past history of Armour, its lack of adverse events and its benefit/risk for those individuals that have been using this drug. As opposed to demanding an NDA from Forest Pharma they should have sat with them and reviewed the long history of this drug, the number of scripts written for this drug and even contacting those physicians/endocrinologists that have been prescribing it for their patients.
The only safety question in my mind is does Armour ingestion, a foreign protein, cause an immune response. This would have been reported by the medical profession if that were the case. Secondly, historically, large segments of the population have been eating pig and pig organ meats for generations without ill affects. The ingestion of a purified material from pig (Armour thyroid a protein) is probably benign. The FDA scientists should know this and counsel their legal staff as to the benign nature of the drug.
Hank
I too have been switched back to Synthroid after several successful years of being on Armour. At this juncture it is too early to tell how this will impact me. Luckily, my physician had the foresight to also put me on Cytomel after I suggested this from my readings. The combination of Armour and Cytomel seemed to work quite well for me without any adverse events.
This next is my opinion so take it as such. I believe the makers of Synthroid (Abbott Ross) in an attempt to increase their sales of Synthroid put pressure on the FDA to require the makers of Armour to submit an NDA. It is a devastatingly poor tactic by Abbott Ross but typical of this industry.
It is unfortunate that the FDA is caught in the middle of this since by statute and law drugs must pass regulatory muster. Where the FDA has failed is in their lack of looking at the long past history of Armour, its lack of adverse events and its benefit/risk for those individuals that have been using this drug. As opposed to demanding an NDA from Forest Pharma they should have sat with them and reviewed the long history of this drug, the number of scripts written for this drug and even contacting those physicians/endocrinologists that have been prescribing it for their patients.
The only safety question in my mind is does Armour ingestion, a foreign protein, cause an immune response. This would have been reported by the medical profession if that were the case. Secondly, historically, large segments of the population have been eating pig and pig organ meats for generations without ill affects. The ingestion of a purified material from pig (Armour thyroid a protein) is probably benign. The FDA scientists should know this and counsel their legal staff as to the benign nature of the drug.
Hank
hfrier@comcast.net
Hank Frier
1
by Dr. G. Pepper | Nov 4, 2009 | general health & nutrition, health, metabolism, misc, thyroid
LA lives in rural America and has no health insurance. After 30 years of effective therapy with Armour Thyroid she is unable to obtain this medication any longer. Her story is a sad reminder of just how far we need to go to provide meaningful health care to the citizens of this country.
LA tells her story like it is:
I knew nothing about this problem of non-availability of Armour Thyroid. I have been on Armour since 1978 and it has worked just fine. I had my annual prescription renewal in June and because I do not have insurance, I was able to get 200 pills at a time for a price break. I take 3 60 mg tablets a day and have been on this dosage for about 6 years, up from a previous dosage of 2 60 mg tablets. Today, 4 Nov 09, I went to pick up a refill that I called in a week ago. I was informed at the pharmacy that Armour Thyroid is no longer being made. Period. I took my last pills on 2 November so I have no medication at all. I have a call in to my doctor but he has not yet returned that call. We contemplated a switch to Synthroid a couple of years ago (for a variety of reasons, none of which are relevant here) but the doctor said it could be a very slow process of finding out exactly what dosage of synthetic hormone would adequately replace the natural Armour. At that time I had insurance that would have covered the lab tests required to determine the proper dosage. I am now without insurance due to the death of my spouse, and because of the hypothyroidism I am unable to obtain health insurance that is even remotely affordable. Therefore I can’t afford all the tests, all the doctor visits, all the rest of the hoopla that woudl go with switching medication. I’ve been fortunate so far that I’ve been able to keep my same doctor, and that he gives me a bit of a break paying cash for my once-a-year-visit, but he’s 60 miles away and I can’t even afford the trips back and forth if I have to start “nudging†a new medication. It’s bad enough to be without the medication for a while, but to think that it will never be available again? I honestly don’t know what to do.
I knew nothing about this problem of non-availability of Armour Thyroid. I have been on Armour since 1978 and it has worked just fine. I had my annual prescription renewal in June and because I do not have insurance, I was able to get 200 pills at a time for a price break. I take 3 60 mg tablets a day and have been on this dosage for about 6 years, up from a previous dosage of 2 60 mg tablets. Today, 4 Nov 09, I went to pick up a refill that I called in a week ago. I was informed at the pharmacy that Armour Thyroid is no longer being made. Period. I took my last pills on 2 November so I have no medication at all. I have a call in to my doctor but he has not yet returned that call. We contemplated a switch to Synthroid a couple of years ago (for a variety of reasons, none of which are relevant here) but the doctor said it could be a very slow process of finding out exactly what dosage of synthetic hormone would adequately replace the natural Armour. At that time I had insurance that would have covered the lab tests required to determine the proper dosage. I am now without insurance due to the death of my spouse, and because of the hypothyroidism I am unable to obtain health insurance that is even remotely affordable. Therefore I can’t afford all the tests, all the doctor visits, all the rest of the hoopla that woudl go with switching medication. I’ve been fortunate so far that I’ve been able to keep my same doctor, and that he gives me a bit of a break paying cash for my once-a-year-visit, but he’s 60 miles away and I can’t even afford the trips back and forth if I have to start “nudging” a new medication. It’s bad enough to be without the medication for a while, but to think that it will never be available again? I honestly don’t know what to do.
LAWHilton@yahoo.com
LA
1
by Dr. G. Pepper | Oct 24, 2009 | fitness, general health & nutrition, health, hormones, metabolism, stress, thyroid
Good things can develop during a crisis situation. For me it was the eye opening experience I had this week by participating in The Thyroid Patient Community Call. The Thyroid Patient Community Call is a group internet telephone call hosted by Janie Bowthorpe, author of Stop The Thyroid Madness. During the 90 minute session I was able to interact with dozens of callers as well as Janie herself. Needless to say, Janie’s audience is mostly individuals who are deeply committed to maintaining Armour Thyroid as a treatment option and who are equally angry with the field of Endocrinology which backs the ban on dessicated thyroid hormone. I knew this audience wanted answers to some very tough and troubling questions. For a few days before the call I needed to review for myself just how this crisis developed, and how I became a lightning rod for the growing controversies. I believe this process was necessary and therapeutic.
Being a strong advocate of t4 plus t3 therapy and of Armour Thyroid, I was in sync with most of the topics being discussed on the call. What was hard for me was hearing the out pouring of stories describing how endocrinologists had alienated (infuriated) so many thyroid patients. How to explain but not excuse the inflexibility, wrong headedness and arrogance of a whole field of medicine on a topic central to its mission, my own field for the past 25 years? My head still hurts thinking about it. For those wanting to hear how this played out can visit Talkshoe.com which hosts these shows and follow the instructions for listening to past episodes of Janie’s show. Perhaps Janie can give more specific instructions by posting them here.
I came away from Janie’s session with a firm recognition that the field of Endocrinology is in serious need of a make-over. Imagine a Democrat walking into a room full of staunch Republicans and asking everyone to join him in a sensitivity training program. It is a lonely job.
by Dr. G. Pepper | Oct 1, 2009 | fitness, general health & nutrition, health, hormones, metabolism, thyroid
Will S., a new member of metabolism.com, offers these sensible comments on who to blame for the sad state of FDA oversight of prescription drugs like Armour Thyroid.
Will argues:
Gatekeeper: Just a suggestion to do a little more research on this situation before blaming it on Obama. It was several years ago, at the end of the Clinton and beginning of the Bush administration, that the FDA began to investigate and reveal that Armour Thyroid had never been officially approved by the regulatory agency. Membership on the FDA consists partially of highly paid executives that came from pharmaceutical companies. It makes sense that they have an interest in making sure that only the big pharmaceutical companies have the money to get their drugs approved. Situations like this are why we need health care reform now. Yes, you certainly can and should bring this issue to the attention of the current administration, but please place blame where it is due, as finger pointing in the wrong direction is unhelpful to those who are suffering.
