Gene DeMambro wrote:
In short, supplements are not tightly regulated by the FDA because the FDA can only regulate supplements as food additives, not as drugs, as per the Dietary Supplement Health and Education Act of 1994 - a federal law. Therefore, the FDA may take action against supplements only if they are proven to be unsafe. The FDA, as a federal agency, can only do what Congress allows them to do, and the applicable federal laws only allow the FDA to go so far.
Indeed
Gene DeMambro wrote:
It has nothing to do with some unholy agreement.
Same thing, Gene. As I stated above, it's kind of like the Clinton "Don't ask; don't tell" policy. Call it food, and we won't regulate it. Imply that it behaves like a pharmaceutical, and we will. This has been challenged and fought out through the years, Gene, and what we have today is the uneasy truce that allows the supplement businesses to continue selling and the consumers of such to keep buying.
Go into one of these places and look at the rows of herbs and other products which claim to modify your physiology. With every such claim there is an asterisk with a footnote that states the FDA has not evaluated the claim.
Gene DeMambro wrote:
If the FDA could, they would hang all these supplement ba$tard$ out to dry....just like they take enforcement action against drug companies who act sleazy.
I wouldn't go that far. This isn't personal. They're just doing their job of protecting the American public.
Gene wrote:
Where can we find the Phase I, II and post marketing trials for Hydroxycut, Uechij?
I don't know Gene...that's why I was asking.
Gene makes my point rather eloquently, and in great detail. I'm glad you finally understand.
You were presuming their homework was done by researching and regurgitating their marketing literature. Sorry, but that's not the science of the drug approval process.
Even under the best conditions, bad drugs make it through the rigorous FDA approval process. Sometimes we don't really understand the potential for harm until after a properly reviewed substance is unleashed on a larger public where human physiological variability meets the typical use patterns. Then when the harm shows up, a new drug is pulled from the market faster than it came on.
This is for prescription medication dispensed by health care providers. Products sold in "health food" stores are nowhere near as carefully reviewed before hitting the market, dispensed to consumers, or monitored during use. Have you ever gotten into a conversation with a typical worker in these places? Check their qualifications some time. Under these conditions, it can take much longer for harm to show up.
I'll give you a good example. I don't know if you're old enough to remember Geritol commercials. It's basically an iron supplement. They sold it with the line "When you've got your health, you've got just about everything." The purchaser of the supplement was to believe that taking Geritol would be good for their health. Well... it turns out that men who have high iron diets actually live shorter lives. Oops!
Not to beat a dead horse to death but I understood there is a difference between the two testing processes all along.
The real question(s) is the supplements industry any less credible just because they go about it a different way? If you say yes, then what makes them so, what are you basing this on...deaths? Has the FDA faired any better death wise?
Just asking
Yes, unfortunately I am old enough to remember the Geritol commercials.
My Shen Is Raised And My Chi Is Strong... I Eat Rice And Train Chi Gung
There is no, "don't ask, don't tell" policy with the FDA and supplements. Federal law, passed by Congress and signed by the President, makes supplements foods. The FDA has to follow the law, just like you and me and everyone else. Indeed, fedaral agencies have lost lawsuits and court cases bacause they overstepped their authority.
And "don't ask, don't tell" is also a federal law as well.
If the makers of Hydroxycut think their product is safe and effective, then they should either put up or shut up.
Few comments. First, I work in a hospital where liver failure patients are admitted to hospital medicine doctors (me) +/- with liver specialists consulting. We see pre and post liver transplant patients every day and are a regional referral hospital for them. When people are evaluated for liver failure bad enough to have a transplant, there is a protocol of what needs to be sent to investigate the cause. They get a history especially for alcohol abuse and toxins, a bunch of scans and ultrasounds, as well as tests for viruses, iron overload, copper damage, autoimmune disorders, biliary obstruction, and so on. You can't proceed without this, so all bad liver injury cases are well investigated. If what was left was hydroxycut, then... well, you won't see me on the stuff anytime soon.
Liver patients MAY have well compensated disease and look relatively normal, but the ones we see in the hospital look awful 90% of the time. They ARE emaciated, or, they have fatty liver and the obesity hides it, or, as was mentioned, they are so overloaded with retained salt and water they become blobs and often leak fluid from their fragile skin. If they're in that state, they weren't on medicine OR they're too sick to take em, usually because the kidneys are giving out. In short, dying of liver failure (or even just living with liver failure) whether I'm wasted away or wasted away + massive edema is not a situation I would voluntarily put myself in.
Having seen people with profound avoidable liver injury (eg, tylenol overdose in a suicide "gesture" that worked too well; erythromycin estolate for a cold which is a formulation which should not be used and should not be given for viruses; kava kava, taken because a health nut wanted to waste some money--the liver failure became a great money sink!) I can tell you it's not worth chancing.
Does that mean, don't take supplements you don't need? Of course! And what about those well tested DRUGS you don't need? Well, those are usually given for a better reason, right? For example, I had a patient turn yellow on oxacillin (penicillin derivative) for endocarditis. He had the drug switched to another, and recovered. But was he glad it saved him from the otherwise 100% fatal illness? Yup.
Can we sometimes use diet and exercise to avoid popping pills which could be toxic? Yes.
Do pharmaceutical companies sometimes delay reports of adverse events or underplay them (Oxycontin), distort and overplay results for physicians (Zetia, new diabetes drugs like Sitagliptin), ghost write articles for them to sign (proton pump inhibitors), reframe standard definitions of improvement to highlght their product (effexor), work the market for every possible cent (branded fluoxetine for PMS), and reformulate garbage drugs to mimic cheap generics just to retain market share (xanax XR), etc? Of course.
Are there side effects even to old and well known drugs we didn't know about a long time? Sure--think ibuprofen like drugs which share the cardiac risks of the newer Cox-2 drugs like Vioxx, in addition to ulcer causing and kidney harming effects.
But I would much much rather take a drug that had been thru the FDA review process, which will guarantee FAR more testing than hydroxycut's several ingredients ever would see individually, plus make sure it was on people in well designed trials with after market monitoring.
It's like buying a new fiberglass car from china instead of a Volvo and wondering what the crash test ratings will show. Actually, since we're talking about supplements, the car isn't a great analogy, because supplements are generally of no value. If they DO something, like red yeast extract (contains pravachol), the FDA jumps in and tries to regulate.
I posted this article because a good number of people who read this forum and are martial artists take supplements. I'm sharing what appears to be both important and valid information.
As I mentioned above, *I* take supplements. However, I do my homework. Right now even cardiologists and neurologists for example prescribe fish oil. One did so recently for my dad.
I did it for informational purposes. Given the *potential* danger involved, I'll take on someone who wants to poo-poo the FDA recommendation to stay away from this stuff. I frankly think coming down on the opposite side of the FDA here is irresponsible, and won't shy away from saying that. Without a thorough FDA review and approval process, erring on the side of caution seems the responsible thing to do here. If for no other reason, consider the liability involved of defending a product that may one day be proven to injure and/or kill people. Not me, thank you.
The libertarian in me however supports the right of people to consume what they want. I want my multivitamins. I'm glad I was able to start taking fish oil before health care providers caught on. My family benefits from probiotics, and now - yes - health care providers have jumped on that bandwagon as well.
But... buyer beware. And if you can achieve an end (weight management) through diet and exercise instead of a weight loss drug or herbal supplement, that seems like the wiser course. But that's me.
I will always come across as fairly antisupplement, because I hate the made up claims and don't trust the reliability or safety. However, I should clarify that most of my vitriol is reserved for "supplements" which I would consider different from vitamins and nutrients.
Fish oil is food more than supplement (to me), and although it may contain heavy metals, etc etc, we know those fats are better for you.
Vitamins are (per data that I am aware of) largely unnecessary, but also unlikely to harm, since most are water soluble and the excess comes out in your urine. A,D,E and K are not, and of these, A can cause serious problems when overused (liver, go figure) and E has a bunch of randomized controlled trials showing no benefit or harm ("antioxidant magic!" splattered all over the bottle or not). K you generally don't need except in unusual health conditions.
D, on the other hand, has piles of good quality data showing improvements in strength, falls, bone density, and mortality (!!!!), and many people are deficient. The Institute of Medicine is considering revising RDAs up substantially (now they're 400-800 IU a day). It's difficult (not impossible) to get too much since humans are designed to live in the sun (but we don't for other reasons these days). I don't know why D isn't more popular; you got people throwing money away on their urine or on things with no real safety or efficacy data, and here's a bunch of D lying around with a known mortality benefit. Go figure.
It's a safe guess that somewhere at Merck today someone is going through the meeting minutes of the day that the hair-brained scheme for the Australasian Journal of Bone and Joint Medicine was launched, and that everyone who was in the room is now going to be fired.
The Scientist has reported that, yes, it's true, Merck cooked up a phony, but real sounding, peer reviewed journal and published favorably looking data for its products in them. Merck paid Elsevier to publish such a tome, which neither appears in MEDLINE or has a website, according to The Scientist.
People familiar with the literature know that some journals are better than others. Obviously this misadventure didn't get very far. And it wouldn't have taken much homework to conclude that this journal wasn't, and the results published in it couldn't have been found in a simple online review of the literature on a topic.
Part of my training on the way to the PhD involved critiquing the literature. This lemon would have been easy to spot. MDs and insurance companies get bombarded by marketing all the time. It doesn't take long to become a cautious cynic.
It takes even less time to sell out and become a doctor who prescribes whatever the pen says, or those antibiotics for colds, you name it!
Merck doesn't just make up lower tier journals. They also managed to get an entirely industry driven report of a trial, written by Merck, signed by some well compensated specialists who received a gentle, public ego pummeling and reprimand for claiming authorship when their role was negligible (I think in JAMA?) later on for being pharmacy sluts, into the New England Journal of Medicine, which is as prestigious a journal as medical trials can get into. This one was on their COX-2 drug Vioxx. And they kinda sorta forgot to be transparent about those cardiovascular events (including deaths) with their papers and promotions for the drug.
So anything you find out there could be tainted. Just like you can find one doctor on either side of any medical issue in the world, for use in malpractice litigation, provided the fee is right; then it's a game of image and Monopoly money for the jurors, who may be left to believe there's a big dispute about clinical issues which are in fact basically resolved.
For my dissertation, I was to take a paper published in Science (a well-respected journal) by a Harvard MD (a well-respected medical school) and take the published results to the development of a biomedical instrument that could detect things like early diabetic neuropathy.
So... The first thing I needed to do was to be able to reproduce this fellow's results in the lab before building a prototype instrument. And so I set out to do that. And I couldn't quite get his results. God knows I tried. For years...
It was reading a book on mathematical chaos that one day made me have one of those slap-the-forehead moments. What this gentleman had proposed in his paper was that rhythms in the body were stable. What I found was just the opposite. And you know what? My results were right. His results were fudged because he THOUGHT that the body should behave a certain way. But the more I researched it, the more I realized that only sick and taxed bodies behaved in a very predictable manner when measuring cardiorespiratory rhythms.
I had my dissertation topic, and got my PhD. Basically I came up behind this dishonest scientist and reported the truth. And I said why what I found made more sense. Bodies at rest were unpredictable because they needed to be so they could respond to the world around them. Hell, PEOPLE are unpredictable under most conditions. That's the world, baby!
What I learned was the following:
Trust your data. Maybe you screwed up your experiment. Or maybe you didn't. In any case, the data are trying to tell you something. Pay attention, record what is going on in real life, and deal with this truth.
Never, ever fudge results. Because if you do, one day it's going to come and bite you in the rear.
Sometimes the greatest and best discoveries come from unexpected results. A great scientist is aware of this, and one day will be rewarded when recognizing new phenomena.
As for the people fudging the COX II inhibitor results, well... Look what it got them? Deciding not to release a potentially harmful drug - or engaging in informed consent - is a lot better off than causing harm and being caught trying to hide the potential for harm.
Bill, are you referring to phenomena like the loss of sinus arrhythmia with neuropathy or age or just saying our heart rate / respirations aren't robotic like a metronome? Obviously there's a lot of simplification taking a dissertation down to a few sentances, but curious. This reminds me of people noticing that tennis players rock back and forth and comment that they should stay centered so they can react to either side without being off balance. When they do, they slow down. Something about the random jitteriness is necessary.
Anyhoo, what did lying about Vioxx get Merck? 2.5 billion dollars a year, according to the first google hit on "vioxx + profits."
Since the company was worried about the drug in 1996,
"On Nov. 21, 1996, a Memo by a Merck official shows the company wrestling with the issue of Vioxx' (Rofecoxib) involvement in increased cardiovascular events. At this early date, Merck avoided a trial to prove Vioxx gentler on the stomach than older painkillers because in such a trial, "there is a substantial chance that significantly higher rates" of cardiovascular problems would be seen in the Vioxx group.
On February 25, 1997, an internal Merck e-mail warned that if a proposed Merck trial was carried out "you will get more thrombotic events" - more blood clots "and kill [the] drug.""
... and the drug not even approved till 1999 and was withdrawn in 2004, then we're talking about ~12.5 billion dollars, provided the take was consistent each year. Who thinks Merck has paid 12.5 billion in lawsuits, development, and advertising for Vioxx?
IJ wrote:
Bill, are you referring to phenomena like the loss of sinus arrhythmia with neuropathy or age or just saying our heart rate / respirations aren't robotic like a metronome? Obviously there's a lot of simplification taking a dissertation down to a few sentances, but curious.
You sort of get it, but it's a bit more complicated than that. I'm talking about the variability of the variability, if that makes sense.
Yes, healthy people have heart-rate variability. Some is due to heart-rate being entrained by the respiratory cycle. Some has to do with the nonlinear nature of blood pressure control. And some has to do with the nonlinear nature of peripheral vascular control.
Imagine taking a heart-rate curve (created by piecing together segments of 1/(R to R interval) ) and doing a Fourier tranform of that signal. That takes a signal in the time domain, and converts it to the frequency domain. If I do a Fourier tranform of a sine wave, I get a peak at the frequency of that sine wave. If I do a Fourier tranform of a heart-rate signal, I get as many as three regions with a peak or peaks.
The issue has to do with how stationary these rhythms are. One would think that for instance the respiratory influence on heart-rate would be stable, yielding a constant amplitude broad peak in the transformed heart-rate signal at the value of the respiratory rate. Well it turns out that it isn't. The peaks in that region of the transformed signal come and go. It's messy - just like Nature. And you know what? That's the way "normal" human physiology works.
You do have a handle on why we might think that measuring these rhythms would give us clues to the onset of diabetic autonomic neuropathy. Basically these rhythms are like "cross talk" within the medullary control centers. With the onset of neuropathy, the cross talk goes away. Indeed people with advanced neuropathy have a metranome-like heart-rate.
IJ wrote:
Who thinks Merck has paid 12.5 billion in lawsuits, development, and advertising for Vioxx?
I do think they paid a princely sum for development, Ian. You have no idea. Multiply the cost of the development of this drug by the many failures that never made it to market.
But that may be looking at a small part of the balance sheet.
It's sort of like the bean counters at Ford deciding that it was OK to sell the Pinto, knowing that it could catch fire in a rear end collision. Well they made money on the car, only to have their reputation tarnished for a generation. It pays - in the very long run - to have and maintain a good reputation with your customers at many levels. Detroit isn't exactly in the black right now.
What goes around comes around. Merck's reputation is tarnished. I would say at this point that the books on this activity aren't yet closed.
Bill Glasheen wrote:
What goes around comes around. Merck's reputation is tarnished. I would say at this point that the books on this activity aren't yet closed.
One thing to note though is that almost every knows when they're buying a ford. I would lay good money that when people go begging their doctors for that miracle drug they saw on TV that they have no idea that it's Merck more often than not. Sure, Merck's reputation may be tarnished in some circles, but the end consumers/patients are mostly oblivious I suspect.
