Lambert here: Here, as generally, “the revolving door” seems a barely adequate metaphor for the pervasiveness of corruption involved; after all, the doors constantly revolve in a house of ill-fame, and it’s the nature of the house itself, not the wear and tear on the hinges of its doors, that is at issue.
By Roy Poses, MD, Clinical Associate Professor of Medicine at Brown University, and the President of FIRM – the Foundation for Integrity and Responsibility in Medicine. Cross posted from the Health Care Renewal website
Who is watching the watchers? A story this week involving “speed”-like drugs added to “dietary supplements” suggests how far the once respected US Food and Drug Administration has fallen.
An Amphetamine-Like Drug Spiking “Nutritional Supplements”
The story began with a paper by Cohen and colleagues published a relatively obscure medical journal, and then picked up by the news media.(1) The main points of the article were:
BMPEA (beta-methylphenylethylamine) is a compound first synthesized in the 1930s as a “potential replacement” for amphetamines. Animal tests revealed amphetamine-like properties. The compound was never tested on humans, and never marketed.
But,
BMPEA remained known only as a research chemical until early 2013 when the FDA identified BMPEA in multiple supplements labelled as containing ‘Acacia rigidula’, even though the stimulant has never been identified or extracted from Acacia rigidula, a shrub native to Texas.
However,
More than two years after the FDA’s discovery, the FDA has yet to warn consumers about the presence of the amphetamine isomer in supplements.
So Cohen et al undertook to identify “nutritional supplements” said to contain acacia rigidula and test them for BMPEA. They found 21 such supplements, all of which tested positive. The authors then recommended,
that supplement manufacturers immediately recall all supplements containing BMPEA, and that the FDA use all its enforcement powers to eliminate BMPEA as an ingredient in dietary supplements. Consumers should be advised to avoid all supplements labelled as containing Acacia rigidula. Physicians should remain alert to the possibility that patients may be inadvertently exposed to synthetic stimulants when consuming weight loss and sports supplements.
Note that while the power of the FDA to regulate “nutritional supplements” is limited by a 1994 law, Cohen and colleagues wrote that it
is tasked with identifying and removing mislabelled, adulterated, and dangerous dietary supplements from the marketplace.
Since BMPEA is apparently not found in nature, and was not sold prior to 1994, putting BMPEA in a “dietary supplement” appears to be adulteration.
The Risks of BMPEA in Nutritional Supplements
The study was then picked up by the media. In the Los Angeles Times, Pieter Cohen, the lead author of the journal article,
said that while the effects of BMPEA are unknown, the compound is potentially dangerous. He said the FDA’s failure to act is ‘completely inexcusable.’
Furthermore, in a CBS report,
BMPEA has not been tested in humans, but led to increased blood pressure in cats and dogs.
‘These are things that are signals that in humans will later turn into heart attacks, strokes and maybe even sudden death,’ Cohen said.
The point is that while it has never been tested fully on humans, there is every reason to suspect that BMPEA acts very similarly to amphetamine, colloquially called “speed.” Amphetamines, as we discussed here, have dangerous side effects, including severe blood pressure elevations, and increased risks of stroke, myocardial infarction (heart attack), and other cardiac events. The drugs also have a high potential for abuse.
Why Did the FDA Do Nothing?
Despite the likely riskiness of BMPEA, the FDA did nothing when it found it in numerous dietary supplements in 2013, and has not indicated that it will do anything now. According to the LA Times,
FDA spokeswoman Juli Putnam acknowledged that the agency published research on the occurrence of BMPEA in Acacia rigidula supplements in 2013.
‘While our review of the available information on products containing BMPEA does not identify a specific safety concern at this time, the FDA will consider taking regulatory action, as appropriate, to protect consumers,’ she said.
In a Consumers Report item, Dr Cohen responded to that,
‘It’s mind boggling,’ said Pieter Cohen, M.D., the Harvard physician who is the lead author of the new study, published online in the journal Drug Testing and Analysis. ‘The companies think they have complete impunity. They assume the FDA will do nothing about it. And they’re right.’
A post in the NY Times Well blog reiterated,
Under federal law, dietary supplements — with some exceptions — can contain only ingredients that are part of the food supply or that were already on the market before 1994. Dr. Cohen said that BMPEA has never been sold as a food or supplement, and as a result any product that contains it is considered adulterated, which would give the F.D.A. the authority to send warning letters to companies that add it to their supplements.
Yet while the FDA had authority to do something, it did nothing.
Was the Revolving Door the Reason?
Back in 2014, we posted about two transitions through the revolving door by the FDA official in charge of the regulation of nutritional supplements. We reproduce the relevant section of the post below:
This round trip through the door was noted rather obliquely in a New York Times article in late April, 2014, focused on how slowly the FDA has reacted to apparently dangerous “dietary supplements,”
Before joining the F.D.A. in 2011, Dr. [Daniel] Fabricant was a top executive at an industry trade group, the Natural Products Association.
The article had previously identified Dr Fabricant as
the director of the division of dietary supplement programs in the agency’s Center for Food Safety and Applied Nutrition.
But,
The F.D.A. recently announced that Dr. Fabricant is leaving the agency this month to return to the trade group as its chief executive.
While the NY Times article thus mentioned as an aside that a government official with major responsibility for regulating dietary supplements had these relationships with the dietary supplement industry, it did not then question whether that relationship had anything to do with slow responses by the FDA to reports of toxic dietary supplements.
In 2014, the Times drew no conclusions about Mr Fabricant’s career trajectory. However, this time
But public health experts contend that the F.D.A.’s reluctance to act in this case is symptomatic of a broader problem. The agency is not effectively policing the $33 billion-a-year supplements industry in part because top agency regulators themselves come from the industry and have conflicts of interest, they say. In recent years, two of the agency’s top officials overseeing supplements — including one currently on the job — were former leaders of the largest supplement industry trade and lobbying group.
Daniel Fabricant, who ran the agency’s division of dietary supplement programs from 2011 to 2014, had been a senior executive at that trade group, the Natural Products Association, which has spent millions of dollars lobbying to block new laws that would hold supplement makers to stricter standards. He left the F.D.A. last year and returned to the association as its chief executive. His current replacement at the F.D.A.’s supplement division also comes from the trade group.
‘To have former officials in the supplement industry become the chief regulators of that industry at the F.D.A. is like the fox guarding the hen house,’ said Michael F. Jacobson, the executive director of the Center for Science in the Public Interest, a consumer advocacy group.
Also, the new Well blog post noted
Shortly before Dr. Fabricant left the F.D.A. in 2014 to return to the association, the F.D.A. hired another official from the group, Cara Welch. She is now the acting director of the agency’s supplement division. Dr. Cohen, who is also an internist at the Cambridge Health Alliance, said he repeatedly wrote to Dr. Welch asking what the agency was going to do about BMPEA, and that she did not respond.
Dr. Welch declined repeated requests for interviews. In a statement, Juli Putnam, an F.D.A. spokeswoman, said that the agency ‘has found that hiring experienced leaders with diverse backgrounds in public health, industry, academia, and science enriches the professional environment and leads to the best health policy outcomes for the American public.’
Before joining the F.D.A., Dr. Welch was the vice president of scientific and regulatory affairs at the Natural Products Association, where she was a staunch defender of the supplement industry. When JAMA, a leading medical journal, raised concerns in a 2011 editorial that the federal law allowed the supplements industry to police itself, Dr. Welch responded that the industry had ‘an excellent safety record.’
‘The industry itself supports and has implemented strong self-regulatory mechanisms,’ she said in an industry news release at the time.
Summary
To summarize, from 2011 to now, the leadership of the part of the FDA that is supposed to regulate dietary supplements was dominated by former top executives of the Natural Products Association, the trade organization for dietary supplement manufacturers. In 2013, FDA scientists found that multiple dietary supplements contained BMPEA, a compound closely related to amphetamines, and hence potentially dangerous and addictive, although it had never been tested on or previously used by humans. Although the FDA had authority to do something about this apparent adulteration of these products, it so far had done nothing. Thus it appears that the currently legal revolving door that allows government regulation to be run by people who come directly from the industries that government is supposed to regulate could be responsible for exposing people to dangerous, addictive drugs.
Remember, BMPEA is a first cousin of amphetamine, amphetamine is “speed,” and as the drug epidemics of the 1960s and 1970s showed us, “speed kills.” So a plausible argument is that the revolving door, as relevant to FDA, has enabled manufacturers of nutritional supplements to become the “pusher man,” a la the Steppenwolf sound track of Easy Rider,
As we noted here, some experts consider the revolving door per se to be corruption, not merely conflict of interest. The current case plausibly suggests not only that the revolving door is corrupt, but that when applied to health care can pose dangers to patients, not merely danger to government finances, government ethics, and the integrity of representative democracy. Nonetheless, up to now, a few people have decried the revolving door (and very occasionally in health care), but nothing has been done about it.
So it is surprising that today (13 April, 2015), the New York Times published an editorial inspired by the BMPEA case, which concluded
consumer advocates are surely right that putting the industry in charge of supplement regulation is like appointing the fox to guard the henhouse. Clearly, the F.D.A. should not allow industry insiders to fill key positions. A permanent solution is for Congress to enact conflict-of-interest laws forcing employees above a certain grade level at any agency to recuse themselves from official actions that affect a former employer or client, including trade associations and their members.
As a minimum, that would be a good start. Unfortunately, even a NY Times editorial hardly guarantees action. At least, however, the problem of the revolving door as a danger to patients has gotten a little less anechoic.
As we last wrote, the continuing egregiousness of the revolving door in health care shows how health care leadership can play mutually beneficial games, regardless of the their effects on patients’ and the public’s health. Once again, true health care reform would cut the ties between government and corporate leaders that have lead to government of, for and by corporate executives rather than the people at large
Reference
1. Cohen PA, Bloszies C, Yee C, Gerona R. An amphetamins isomer whose efficacy and safety in humans has never been studied, beta-methylphenylethylamine (BMPEA), is found in multiple dietary supplements. Drug Testing Analysis 2015; DOI: 10.1002/dta.1793 Link here.
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a bit of a tangent, but it’s uncanny how monster/suicide/america rings truer today than it ever did.
Sec. 211.34 Consultants.
Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. (see…they’ve digested too much of their own crap)
“If one day the speed kills me, do not cry because I was smiling.”
Paul Walker, September 12, 1973 – November 30, 2013/american roll model
Is “roll” model a freudian slip or a clever (but sort of evil) joke?
The NY Times article, like this one here, are a highly deceptive pieces. As usually with propaganda pieces the big picture is dubiously absent from the narrative.
The NY Times is a leader of the mainstream media pack, a cartel that mainly serves and protects the mainstream ideologies of the ruling authorities.
Contrary to the gist of this NYT propaganda piece, the biggest foxes protecting the henhouse are the medical industry, the GMO industry, the junk food industry, etc all of which are multiple times larger and more profitable than the comparatively small supplement industry. The FDA has a long history of pandering to this big money and trying to squash the supplement industry and other therapies of alternative medicine.
It is almost always the same ol’ game the mass media and the official authorities play: distracting the unsuspecting general public from seeing the bigger picture truth behind it all which is that the lack of meaningful regulation argument is used by the mainstream medical establishment to mislead the public into thinking that dietary supplements pose a great threat to their health.
But if you look past their hype you will recognize that a “highly FDA-regulated” market such as the medical industry cause multiple times more damage to public health than the “lightly regulated” supplements (the difference is like night and day!), and that many of the claims of benefit of medical products are little more than fabricated “scientific” lies (do a search engine query for “Tougher Supplement Regulation: A Necessity Or Politics?”).
Or… the US government – that is, the FDA, that is the medical-federal-industrial complex – has given itself the right to lie to the public about the most destructive “safety”-approved medical products they are exposed to as allopathic pharma drug alone kill over 100, 000 people each year in the US alone. Or, the way the orthodox medical establishment is set up, the biggest recipe for trouble is already in place: it’s called “evidence-based” orthodox medicine.
The spurious calls for more federal regulation of supplements and anti-supplement rants are usually little more than total public deception.
1. By the gist of your comment, you apparently have never read this site or the Health Care Renewal blog. NC regularly bashes the New York Times, and both we and Health Care Renewal also frequently criticize the FDA for its lapses in the regulation of drugs.
2. In a typical straw man ruse, you do not address this particular case (and this post is about a specific, problematic dietary supplement) but instead mischaracterize this post as being in opposition to dietary supplements generally.
3. I am a regular user of dietary supplements and lived in Australia, where dietary supplements are regulated and required to be manufactured to pharmaceutical grade standards. There are some supplements I buy now from Australia because I know when I buy them that they are the purity and potency promised. By contrast, the lack of regulation of dietary supplements in the US means that consumers are too often getting less than what they think they are getting. The downside of Australia’s regime is that they do not allow hormones like DHEA to be sold over the counter. But in general, I prefer the Australian regime to the US one.
The article does not attack the supplement industry. The supplement industry is under “threat” of regulation that will remove products from the shelves. Many people are very sensitive to issues related to this industry. The article really discusses ending the practice of revolving doors which would help solve a lot of problems in this country.
This case in particular is egregious. The product is a fraud and also potentially fatal. The failure of the FDA to remove this product from the shelves is difficult to explain except for regulation capture.
It also calls into question the role of the trade group. Why are they defending a product that is clearly fraudulent? If this product does cause a death then it will cast a shadow on all supplement companies.
As for Big Pharma vs Big Supplement the data is clear. Big Pharma is more dangerous. The 3rd leading cause of death in America is the proper use of pharmaceuticals. I’ve never seen anyone add overdoses into the number of deaths. I doubt that would push it into #2.
I am not sure if I want a mandatory purity testing regime. I support it but I fear that it would eliminate many of the smaller supplement companies that can not afford the testing. Companies like Naturemade are already testing their products but I do not use and will not recommend the majority of their products once I graduate.
For instance, the companies that offer a full spectrum Vitamin E supplement are small and can not afford USP testing. Naturemade sells a synthetic Vitamin E that is USP tested. I would not use and do not recommend that anyone use a concentrated Vitamin E supplement especially DL-Alpha. I do however buy it to help preserve my dogs homemade food.
My issue with this post is that it calls for giving the FDA more power to regulate supplements, and I do not trust the FDA in this capacity. The FDA has been completely captured by big Ag and Pharma. There are a lot of garbage supplements and I assume that the biggest offenders are the usual suspects, or their subsidiaries.
People do need protection from bad supplements, but don’t expect it to come from the FDA. If you give them more power they will use it to attack good supplement providers.
The FDA and the CDC are rotten to the core.
And Big Supplement is not a concern? A “$30-billion-per-year (USD, 2011) industry with little regulatory oversight.” Quoted from Science Based Medicine, from one of their articles on the topic: https://www.sciencebasedmedicine.org/were-a-drug-taking-supplement-taking-nation-so-how-do-we-do-so-safely/
Lee, Science Based Medicine is a joke. Aren’t they being sued and in court because they went after the wrong company or was that Quackwatch?
Groups like Science Based Medicine are losing their ability to put good doctors out of work due to self-funded employee plans, health insurance companies and the empowerment of patients. These groups are looking deep into why healthcare costs are so high and it is because of mainstream medicine and their prescribing habits. If you value your life you will steer clear of traditional medicine and the “Science Based Medicine” type groups.
Not sure what you mean by “traditional medicine”. If by that you mean that which is practiced by MDs, all I can say is they’ve saved my life, kept me from being a pain-racked cripple and the list, particularly at my age, could and will most likely go on.
If I’d stayed away from what I assume you mean by “traditional medicine” (apologies if I’m mistaken) I’d be long gone and therefore not here to irritate you with my views. Also worth mentioning are my futile attempts to seek help from practitioners of “alternative medicine”, specifically acupuncture, for conditions that were at last cured by surgery in one instance and little white pill in the other.
I have had some negative experiences with conventional medicine and I know there are some good things happening outside its realm, but to utterly reject all its works is hardly sound advice.
Being sued is not necessarily an indication of wrongdoing. SBM’s, Steve Novella, characterizes the suit as “legal thuggery in an attempt to intimidate me and silence my free speech because he finds its content inconvenient.” https://www.sciencebasedmedicine.org/another-lawsuit-to-suppress-legitimate-criticism-this-time-sbm/
You can take traditional medicine, have all you want for all I care but leave me out of it. I was poisoned by them by a product (GE’s Omniscan) that never should have been approved by the FDA. Personally I won’t ever go the traditional route again and although not the only reason it is one of the main reasons. Omniscan and Magnevist (Bayer’s product) has a black box warning and yet it is still being injected into people to the tune of millions of doses a year. And now we find the toxic metal gadolinium used in these gadolinium-based contrasting agents are being excreted into our water ways and still they continue injecting innocent people with these toxic products.
Are you Steve Novella Lee? I heard he posts under multiple aliases for self-serving reasons.
Pharma has us coming and going.
Healthy babies get vaccines.
Children get ADHD medicines.
Adults get anti-depressants, cholesterol lowering drugs, and diabetes treatments.
Now there is a concerted legislative push to erode the Personal Belief Exemption for vaccines. Over 100 bills in 30+ states seek to make it harder for adults and parents to say no to a vaccination. Computerized vaccine registration databases are on the way. It is a medical dystopian nightmare they’re trying to get over on us.
See https://nvicadvocacy.org/members/Home.aspx for bill details.
I agree with you Ernesto Lyon. As someone that has been poisoned by a product that should never have been approved by the FDA and that is still on the market (GE’s product Omniscan) we are now finding that gadolinium from the gadolinium-based contrasting agents are in our drinking water and widespread. And as a former auditor with the OIG of the DHHS I also believe the CDC, the FDA and the NIH are rotten to the core and the FDA will only go after supplements that are pure. They do this at the behest of large pharmaceutical companies or as you said Big Ag and Big Pharma.
I take lots of supplements too Yves and I can assure you I make sure they are pure. What I don’t take are pharmaceutical drugs unless I absolutely have to. And we have this to think about. Over 400,000 people die a year from preventable medical error. A high percentage of those that die are due to prescription drugs. Can it be any worse than that?
This is what Perelman refers to his book *Railroading Economics*. I’m sorry Yves but I respectfully disagree with you. The entire medical paradigm is rigged against health and I also agree with RobynD. We have a predatory system that puts profits before patient safety and an FDA that suppresses cures or non-invasive diagnostics.
Disclosure: Poisoned by gadolinium-based contrasting agents used for MRIs for breast cancer screening I didn’t need.
Pedantic, of course, but I much prefer Curtis Mayfield’s Pusherman. A classic.
The current case plausibly suggests not only that the revolving door is corrupt, but that when applied to health care can pose dangers to patients, not merely danger to government finances, government ethics, and the integrity of representative democracy. Nonetheless, up to now, a few people have decried the revolving door (and very occasionally in health care), but nothing has been done about it.
Given the net vector (I know, redundant) of the political economy that people willing to act in their own “libertarian interests” have established, what, other than plaintive, serious, concerned, outraged notice and comment, can actually be “done about it”? There must be something– electing more Demicrats ain’t gonna do it apparently…
Another example of Bill Blacks’ Greshams’ dynamic, the bad drives out the good. Also a pretty good answer to a question I recently asked myself while standing in a Tibetan herb shop. “Why do I trust a Tibetan plant vendor more than the US pharmaceutical industry when looking for medical remedies”? My first answer was, “worked in the biz for 30 years, no contest”.
An excellent article and great work by FIRM. It’s a simple fact that at no time has government acted in the interest of the people it represents without outside pressure being applied by those same people. Articles like this and resultant calls and shaming of the implicated figures involved will greatly help reduce this threat. I suspect that class action lawsuits are being put together surrounding these supplements that will wallop the bottom line of the companies that push this nonsense on the unsuspecting public. To me it shows the constant need to press on authorities and representatitves for every single issue of importance. There’s too much profit to be had from being corrupt and too little incentive from traditional sources of protection (journalists and regulators) to actually do anything. So keep pressing on this. Call your rep. Write a letter. Demand an answer.
It represents a two tiered risk for people taking the supplements. The first group are people who don’t know what’s actually in it and could have allergies and other adverse reactions. The second are people who know and desire the secret ingredient and are burned by whatever lab they’re using not creating standard potency or delivering what they’re supposed to, leading to the sort of adverse effects as experienced by the first groups.
OFF TOPIC: Yves, I really like your oil posts by Berman, but your friend Mosler is saying the exact opposite.
http://moslereconomics.com/2015/04/09/saudi-output-5/
Does he have a point??
I am always entertained by the way people’s given names tend to show their true natures or biases. Take “Fabricant” for example which means “‘manufacturer” which, of course, can describe the work of Mr. Fabricant. Then there is “Welch” which means to “not do what you are supposed to do.” Oh, how lovely is the English language that borrows from hither and yon!
If the products do not contain Acacia rigidula, then how do they get away with saying they do? Wouldn’t that constitute some kind of fraud?
Product labeling has really gone to sh*t. Just recently it became apparent that Traders Joes products are slipping in quality. Dietary needs require I read product labels carefully so I noticed the change. I’m going to guess they changed manufacturers.
And I still can’t get over there was little real repercussion for all of those thousands of pets that died as a result of Chinese melamine in pet food.
Likewise in body care. Unilever’s pulled the silver ions out of their Degree deodorant recently. About the only thing left you can honest-to-goddess trust anymore is Dr. Bronner’s.
didnt the gop remove the FDA from regulating supplements back in the 1990s? and seems like that it was fairly recently that we heard that some of them didnt have what the labels said they did. course many would like to get insurance companies to help pay for them (without their rules of course). but that seems unlikely as insurance companies dont want top pay unless they have some chance of success. and for all of the mess the FDA does make, they at least require tests and studies be done to at least have a suggestion that the drugs will work.
The testing required by the FDA is the bare minimum to assure that too many people don’t die or suffer severe side effects in close proximity to ingestion.
Here’s how the CDC and FDA work. Young people enter the agencies right out of college, in their early 20’s. At 20 years service they get their pension, but they still have a long career in front of them, being only in the early 40’s. So, with their last few years of service they start casting about for jobs in the industries they regulate. They make friends, they turn favors. They then land cushy jobs with Pharma and Ag, but have deep connections back to their former agencies.
The FDA and CDC are rotten to the core.
The nasty thing about unlabeled substances in supplements is that they create exponentially more risks to the health of people who take them.
A regulated product has its label, a person can check this for allergies, contraindications, and cease taking it if they have any sort of reaction.
An unregulated product with undisclosed ingredients which become known to some but not all customers creates two tiers of users with two tiers of potential risks.
Group A. knows that there is an amph or tram analogue in the Happy Jingo Root Bark and takes it for this purpose. What they can’t know is the real dosage or purity of this adulterant, causing a very real possibility of overdose or sudden withdrawal as purity and dosage varies throughout batches.
Groub B does not know about the undisclosed ingredients. They’re at risk of both allergic reaction and other causes of contraindications to a substance they don’t know they’re taking.
If they have an allergic reaction and go to the hospital with their supplement bottle, the nurse writes down the supplement, the pharmacist looks at ingredients on the bottle, everyone is in the dark about the actual cause of the reaction, leaving the person to have a second fatal reaction when they encounter the same unlabeled substance in a different supplement.
Or if their heart pills stop working, they show the supplement, again, not realizing that the cause isn’t on the bottle, and their pharmacist says ‘oh no, there’s nothing here that could cause that.’
Why do we have to regress like this. We have regulations about labeling for very good reasons.
The FDA has long hated, detested, and persecuted nutritional supplements. Perhaps the FDA thought that allowing this BMPEA to sneak into nutritional supplements unaddressed would lead to the discrediting-by-association of nutritional supplements in general. Perhaps certain “hidden hand black advance” sappers within or connected to the FDA might have put the BMPEA into the supplements on purpose under acacia cover in order to manufacture a nutritional-supplement-discrediting incident? Perhaps some of the supplement companies with BMPEA in their products might be secret FDA/CIA/etc. proprietaries?
“The tinfoil is strong with this one” . . . Yes, I know. I am not sure if I really believe any of that. But I think it is worthwhile thinking in this parallel way for just a while to see where thought ends up, given how long FDA has consistently wanted to destroy the nutritional supplement industry. Widely spreading distrust for nutritional supplements in general would certainly fit in with FDA’s long-term goal of destroying the nutritional supplement industry.