Diet Drugs: The Public Is The Loser
This is the system we want to run health care.
Civil liberties get lost, people spend a lot of money writing spy reports and then don’t read them. There is little in government that works.
I know the system that the FDA wants for drugs does not work.
First, you know nobody will use it with diet and exercise as recommended. They are both dull, not fun, and in the literature I read changes that are increasingly modest seem to be acceptable, and take a team of cheerleaders. Even “natural” companies, like Metagenics, have gone and credentialed counselors to help with lifestyle changes.
I know because I got the credential in First Line Therapy (FLT) , and had it on my wall with all my other diplomas and certificates for a while. They did let medical doctors in the course, but with the assumption they would be supervising people with extremely low level credentials — such as bachelors-level nutritionists and 9-month program-trained holistic health counselors. They would not pay them much, and they would funnel these patients back to the MD for regular checkups.
The low-level “therapists” — who are usually struggling to fill up their practices — would be grateful for seeing these (cash-only) patients and –for example — tell someone who ate 14 tortillas an evening to cut down on the number slowly.
(This is southern California and that was a real case study.)
But back to the anti-fat pill.
It has effects on pregnant women and psychiatric side effects and it can make your heart go too fast. However, when the choice comes down to looking better (thinner) or risking your life, the public always chooses thinner.
History repeats itself, and the stock of Vivus Inc — the company that makes this new pill — is already up.
In anticipation, presumably, of a positive announcement on October 28.
So I checked out the FDA site.
This one opens a PDF file, but you can get to it from the one above.
First things first: No wonder the stock went up. It is one of those “combination” pills, like Eli Lilly Symbiax.
That means the company simply combined two drugs already approved by the FDA into one pill. Fewer pills for the patient to take does increase the likelihood the patient will actually take it.
I know of no other advantage for the patient. The benefit is for the doctor who has trouble counting, or who has a tired hand and does not want to write even one more prescription, or simply does not give a damn about finding the exact amount of medication that makes the patient more comfortable.
Oh yes — and there’s a big benefit (PROFIT$$) for the drug company.
Back to the fat pill.
They call it Qnexa, or VI-0521; immediate release phentermine (Yes — half of Fen-Phen) at 1/8 to 1/2 of marketed dose; and delayed-release topiramate at 1/16 to 1/4 of marketed dose.
These drugs have been around for 50 and 13 years respectively, and folks use a lot of topiramate as an anticonvulsant to control seizures.
As a matter of fact, both have been around for more than 8 years — the magic number for a patent to expire — so there are cheap generics and a manufacturer can make bigger profits than they would licensing a patented (or TWO patented) drug.
I’ve used topiramate with patients both as a neurologist/neurosurgeon and as a psychiatrist. But I would NEVER use a drug for weight loss for a patient or for myself.
All weight loss drugs on the market are dangerous, and prescribing them is — if not illegal or ethical — absolutely nuts.
Gastric bypass is safer than diet drugs — and the bypass is horrible and dangerous too. So neither option is reasonable unless you are a doctor in a system that emphasizes quick turn-around of patient visits, maximized profits from bariatric surgery or perks from drug companies for prescribing their nostrums. And assuming you can sleep at night and still look at yourself in the mirror.
Weight loss can be approached a thousand safer ways. Book stores and libraries are full of them. I’m writing about my own weight-loss odyssey for an upcoming book, and I’ve tried everything over the past 35 or 40 years.
They say this drug — Qnexa — will only be approved for those at medical risk from their weight gain. If you believe that, I have some oceanfront property in Arizona. I see the women already, seeing advertisements on TV, begging their doctors, telling the latter how much healthier they will be from the money they save on their wardrobes.
I’ve seen too many doctors — usually on Court TV fighting for their freedom — who are only too glad to write whatever prescription a patient is willing to pay for (even writing to fictional names so multiple pharmacies can be convinced to fill the prescriptions).
Think of the doctors who “took care” of Elvis, Michael Jackson, Anna Nicole Smith and too many other unfortunates.
Has it occurred to anybody — especially doctors — that many drugs have weight gain as a side effect?
I was one of the researchers who worked on the anti psychotic now named Zyprexa to get it approved by the FDA. By the time I got involved, it had already been through years of study, first on animals and then on healthy humans (to see if it made them sick or killed them), and I was involved in what is called “Phase III” — where we determine the effective dosage on a patient by giving an existing drug or the new drug in a double-blind clinical trial.
You can’t use a placebo on people who are so seriously ill — it would be inhumane. So Eli Lilly set up a study using Haldol (an old drug that was the standard at that time, but which has horribly uncomfortable side effects), against the new Zyprexa.
The Zyprexa was a marvelous breakthrough. The neurological problems of shaking and twitching movements, the muscular soreness and stiffness, and other bad side-effects of the old anti psychotics were gone. Zyprexa easily won approval and went to market.
I moved on also, and about five years later I found myself consulting in a clinic in Central California where Zyprexa was liberally prescribed. To my horror, I found that many of the patients put on so much weight that they either developed Type II diabetes, or were at risk for developing it.
Weight gain …. one of the main reasons patients become non-compliant. They would often have a terrible illness than look fat.
Now the FDA requires a “black box” warning on Zyprexa (which is available as a generic called olanzapine). There is a warning, much like you see on a pack of cigarettes, with a bold black box drawn around it so you won’t miss it, and it says that if you take this drug, you are at an increased risk for rapid weight gain, diabetes and pancreatitis.
But it’s still on the market.
I have asked patients how they think diet medication works. Some shrug their shoulders, but many tell me it makes food taste like cardboard or some equivalent. It probably does something to make your tummy feel full, and to move the digestive process along quickly to elimination.
In higher doses topiramate is used in both seizures and headaches, but I have seen lots of patients who cannot tolerate therapeutic doses because it puts them to sleep all day. Still, if you have a horrible migraine or suffer seizures, it is a useful drug for some patients.
And those who tell me it does not work in the lower doses simply do not bother to take it. Again — non-compliance.
As for phentermine, it was considered the “safer” half of Fen-Phen (the supposedly dangerous part – fenfluramine, also known as Pondimin — was blamed in causing disease in heart valves and pulmonary hypertension and pulled from the market in 1997. Many people get it on the black market by ordering it from foreign countries. Again, looking good is better than having good health to some people.)
The phentermine list of side effects seems to bear a suspicious resemblance to the current FDA concerns about Qnexa. Hmmm…. I guess this is why the stock is up and the makers are probably fairly confident things are going forward.
Phentermine is a good old reliable appetite suppressant of the same class as amphetamines — an abusable but popular diet drug for many, many years. Phenethylamine is in chocolate, and some have postulated this is why lovesick people (yes — men as well as women) go for chocolate. But alas, the Wikipedia folks are probably right that it would be metabolized by MAOB ( a form of monoamine oxidase enzyme) and not make it to the brain.
But this is one place that I do not much mind the science, because any phenethylamine I need is going to come from chocolate, which seems to be my ideal source. (And yes — I lost weight while continuing to eat chocolate — and ice cream — and — )
Now back to this exciting new Qnexa deal, and the FDA paper on same. They are so confident that after approval they plan to do pediatric studies. That’s right — giving a drug with suspected health risks to kiddies. Childhood obesity has been getting a lot of publicity this year and the company’s data suggests people can lose more weight with the combination of drugs in Qnexa than with either drug alone.
There seems to be no synergistic toxicity. That is “doctor-speak” meaning it is no worse to take these drugs together than it is to take either alone. Now that FDA document has detailed clinical trial data and some nifty graphs, but this is so much cheaper than anyone actually developing a new drug, and there is so much money to be made from this, that reading the document induced nausea in me.
In fact, if the subject were not so serious, I would advise reading this document as part of a weight loss program, if your program was bulimia.
But this is serious business.
The instructions to doctors — or clinical assessment section — contains a whole bunch of nonbinding recommendations. Of course they urge the doctor to monitor the patient closely. But in a system that gives 90-day prescriptions and a ten-minute checkup once in that time period, how much monitoring can there be?
Most doctors rely on the old, “If you feel bad call 911 or go to an emergency room.”
One of the best outcomes for the drug company and the clinics is that adding this combo-drug to the formulary is a way to get insurance pay for weight loss, which in most circumstances it can’t do. This is the site of one hospital that uses the “LEARN” program recommended by the folks who make Qnexa. They say it is the best. I have not been able to locate any unbiased source that agrees. It is proprietary, which means you have to pay to use it.
Me, the one study I would love to see but know I never will, is how the LEARN program works with Qnexa as opposed to the program without Qnexa. Once people have an agreement, nobody tends to do anything to threaten profits.
Once, when I was at a higher weight, a thin — and definitely non-stupid — friend told me to go for bariatric surgery. I can see why she recommended it. I was definitely in a dangerous category of obesity, and she wanted the best for me. She — like most of the public — was exposed to TV commercials and billboards that extol the virtues of such surgery.
However, it does have complications that are not publicized, and death is a rare one. I told her I was not going to do this and I was working on other ways. I’m glad those other ways worked. For one thing, I am much healthier and happier. For another, I don’t look like a stubborn fat person to my friend. Once, when I was at nearly the peak of my weight, a specialist in endocrinology and metabolism wanted to prescribe me Meridia.
At the time I was getting my routine health care at the VA, and as a superior officer, I felt like calling in an air strike against him. But I did not. I simply refused the drug, since one of the side effects is sudden death. See above.
Besides, he is probably still stuck at the same VA where I met him; something I believe to be punishment enough. The makers of Qnexa have a typically self-congratulatory website, from which I can learn little — and you can probably be easily misled.
In addition to obesity, the FDA seems to be concerned about this drug combo inducing sleep apnea and erectile dysfunction.
The latter would seem to undo all the goodwill the company received from weight loss.
When I talk about drug companies and the shenanigans involved in jumping through hoops for the FDA and getting the public on-board with new products, I’m not dishing out conspiracy theories here. I think we are dealing with nothing more than the profit motive that dominates all industries.
When I started taking training in medicine, I was idealistic enough to expect more, even when — in France mind you — the drug companies not only fed me but gave me wonderful textbooks to supplement my curriculum.
It’s like they adopt the medical student, help her through the financial tough times, and then become the Godfather — expecting a return of favors later in life.
Of course, it was hard not to notice in the course of my education when the dean of the med school’s second wife was a very hot drug rep, or how toward the end of the French part of my career, the drug companies seemed to send me an awful lot of sales reps (male) who looked as if they pumped iron, while the male med students were visited by sales ladies who seemed to have recently competed for the Miss Universe pageant.
Corporations have a responsibility to make a profit for their shareholders. They want and need to make as much as possible. This is not new or evil. It is the way of the world, and has been for a while.
Now there may be some occasions when the situation is worse in the United States than other places, (you haven’t forgotten the government bail-outs of all those businesses who were “too big to fail” have you?) but it exists to some degree everywhere.
The problem is with those who are, like one of my preceptors once called me, “morally rigid.” I am a humanist and want more for my patients, who are, after all, human beings like me. So I think of it as a kind of race based chauvinism. I cannot get as worried about animals and their rights as I do about humans, who seem considerably less well protected in this society.
Regulation by the government is no answer. I have the vivid memory of a drug company sponsored junket, a boat tour of Alcatraz harbor, off San Francisco, that was sponsored by Eli Lilly. They really won me over because their representative passed me the fancy hors d’oeuvre and told me to eat more expensive French cheese because it would stop me from getting seasick.
I’m embarrassed at how cheaply I was bought off … I’m better than that now.
I was involved in drug research for quite a few years and dealt extensively with the government. The FDA employees are decent folk, not James Bond level super-villains. Their job is impossible. They are bureaucrats; confused, overworked and stuck in an unbelievable bureaucracy.
They need to read more dull technical and difficult literature than any human being could digest even given an infinite amount of time. But they work under deadlines.
It is no wonder our government agencies degenerate into redundant messes, and the FDA surely cannot do anything near what it is charged with.
The only way to resolve anything is to work to cultivate intelligent consumers, and strive to be ethical, compassionate doctors who can help them make the best choices according to their circumstances.
Our current health care bureaucracy makes this impossible. No proposed health care reforms that I’ve studied make it any more possible.
If my tone sounds like cynicism, I think it is pragmatism and accepting reality.
The best I can do is become the best I can — and then do.