July 01, 2009

Who Has the Profit Motive?

Science-based medicine = Big Pharma? You hear it all the time from the peddlers of woo, but it's rare that they disclose their own profit motives.

Take the fellow who used Greg's recent post on the FDA and acetaminophen to complain about how the FDA conducts itself.

I think more people need to take a bigger picture approach to this latest FDA news. Who is the FDA ultimately protecting? How long do they wait, how many lives are affected before they take this kind of action on big pharma drugs? Too long. How long do they wait to come down hard on the natural health industry when a few people lose their sense of smell (for example)? Not that long. The makers of Zicam got dragged through the media a few weeks ago after 100 or so people lost their sense of smell temporarily over a ten year period, but it takes 20 years or so for the FDA to say anything about the drug that is the leading cause of liver failure in the U.S.

Set aside the fact that the post quotes an article talking about the years-long educational campaigns conducted by the government to help keep people from using acetaminophen dangerously. Set aside the fact that this is not the first FDA action on acetaminophen. Ben, the commenter, did, after all. Even after this was pointed out to him, he accused the FDA of "purposely staying silent" on the subject.

Ben wanted to "focus...on the priorities of the FDA." Of course, contrarian that I am, that only makes me look at Ben's priorities, particularly since I just looked at the FDA's and he ignored what I said.

Ben was kind enough to provide a link to the blog for his company, Swanson Vitamins. So I took a look at the company, specifically in regard to things he didn't think the FDA should be focusing on.

Zicam, of course, is the "homeopathic" cold/allergy/wealth remedy, at least one formulation of which actually contains an active ingredient (unlike most homeopathic remedies, which are just water). The FDA recently released a consumer warning that Zicam Cold nasal gels can temporarily or permanently impair users' sense of smell. That may not sound so awful, but it's an ugly condition.

Now, as Ben pointed out, his company's site doesn't carry the Cold products. Of course, those can't currently be marketed without FDA approval, so that's not evidence of care for their customers. They do, however, continue to carry other Zicam products, even after:

There have been 130 cases reported to the FDA of decreased sense of smell following the use of one of these Zicam products - sometimes after a single use, sometimes after repeated use. All of these cases were reported by patients or their doctors; none were reported by the company, Matrixx Initiatives. According to reports, the FDA has asked Matrixx to turn over 800 consumer complaints regarding to Zicam. There is a 2007 law that requires company to report such complaints to the FDA, although the FDA has not said whether Matrixx violated this law.

Swanson Vitamins could choose not to carry any of these Zicam products in order to protect their customers. They don't. They are instead choosing to ignore a company history of unsafe formulations and failure to report problems with their own products in order to continue to promote a popular brand name of woo.

Ben points to the fact that the other Zicam products haven't been dunned by the FDA. He links to an article on his own blog that says that the FTC and FDA have regulatory powers over "natural" medicines. What he doesn't tell you:

While most homeopathic remedies are diluted to the point that they are indistinguishable from water, that is not a requirement. Lesser dilutions may contain small amounts of active ingredient. If a “homeopathic remedy” contains a biological active amount of a drug as an active ingredient, is it not a regular drug?

This is relevant to Zicam because these products are regulated as homeopathic drugs - which means they were allowed on the market without having to provide any evidence for safety or efficacy.The homeopathic exception allowed the manufacturer to simply bypass the usual requirements, even though Zicam is not really homeopathic but contains biologically active levels of zinc.

Why doesn't he tell you that? Why doesn't he tell you the the FTC has only the power to make sure he's not making direct medical claims for his products? Well, you could ask Ben, or you could just read the title of this post again.

Update: Note that a profit motive can also encourage other unethical behavior. As Jason points out in the comments, the astroturfers from Swansons Vitamins have arrived.


Jason Thibeault said...

Interestingly, according to a commenter on Orac's blog, the minimum accepted dissolution of zinc according to the homeopathic "bible" is 2X, which means, where 1X = 1:10 ratio, 2X is 1:100. That's still a shitload of zinc to be cramming up your nose.

Jason Thibeault said...

To clarify, that means it counts as homeopathic according to the homeopaths' own guidelines. That's why it falls under jurisdiction of that old 1938 law that allowed it to slip into the public arena. And I believe that 1:100 isn't necessarily 1 part zinc to 100 parts distilled water in this case, as this is a gel and would need hardly any water so it could be even higher than that. I'm trying to find exact measurements of the amount of zinc present in Zicam but unsurprisingly I'm finding it really difficult to find.

Dan J said...

I like this quote from one of Swanson Vitamins' pages:

"As for the consumer, all these regulations can lead to some confusion. Why? Because companies like Swanson Vitamins that follow the rules to the letter often can’t advertise the benefits of dietary supplements."

Oh, come on. You can advertise those benefits all you want. But first you have to prove that those benefits exist.

Stephanie Zvan said...

Good luck, Jason. Being homeopathic means never having to say you're sorry...or what's in your product.

Dan, that is the problem, isn't it?

Drugmonkey said...

OMG! You too? BigPharma must be paying off anyone with an influential blog, aieeeeee!

Evita said...

I feel that this article is more of a personal attack than an actual case for or against anything.

Yes some people abuse the market of natural health and give a bad name to the rest, but at the same time, drug companies are killing people everyday and literally nothing is being done about it.

While a lot of people still think the FDA is a credible governing body, sooner or later we are all going to wake up and realize that the only worthy governing body is your own intuition and wisdom - and I say that as a scientist.

Scientific studies today are flawed beyond belief and in the end it is the poor consumer who suffers this abuse because they are lead to believe false results which they do not understand and fully look into themselves.

The truth is the FDA and drug companies are best friends (aside from the literature available on this, they themselves do not make it a secret) so naturally they are threatened by anyone else who may interfere with their profits and do away with them quickly and blow the tiniest things out of proportion.

When it comes to the FDA being a credible governing body, the acetominaphen is just one example and let's not even go to the asparatame controversy.

All I wish is for more people to be more open minded and realize that the only people or organizations looking out for your safety and best interest today is no one else than you - yourself. And if you hand over your power to someone else ever, you have nothing but dissapointment to face in the future.

Don W. said...

How can you possibly fully support the FDA? Look at all of the terrible antipsychotics, SSRIs, and other drugs that are being fully approved to be prescribed for 20-30 years of use, when they have only been studied for on average 2 weeks. The FDA approves brain altering drugs, and they are prescribed to children, often 3-5 years old. People need to quit relying on the FDA to tell them what is safe, because they aren't doing a great job. They do a good job, but not a great one. Vaccines, Antidepressants, and on and on, are dangerous, but fully approved because they make big money.

As for natural products - those can be dangerous too. Do you know why they are dangerous? Because they are active compounds that can actually work when used properly. Unfortunately, it is nearly impossible for alternative health companies to tell their customers exactly what their products can be used for due to FDA and FTC regulations.

The average 'natural' product is far safer than the average 'drug' that is approved by the FDA. Is there still dangers with taking a 'natural' product? Of course. People need to be educated, and should find a doctor that can help them safely use natural products in addition to the occasional prescription drug when necessary.

Jason Thibeault said...

Well. THERE'S pretty good circumstantial evidence that astroturfers are out in full force.

Stephanie Zvan said...

Aw, DM, did you just call me influental?

Jason, you'd think they'd be savvy enough to realize that can be tracked.

Swansons Vitamins employees: welcome to the blog. You may wish to keep in mind that, while I prefer to protect the privacy of individual commenters, I have no such regard for corporations.

Don W said...

Who cares about being tracked? I'd prefer that you respond to my comment, not my location. Thanks.

Jason Thibeault said...

I have a question for the Swanson employees that have shown up to defend their profit motive:

How much zinc is in Zicam? As you are internal, you have access to this information.

Also, can you point out any scientific studies done by your company that prove that this level of zinc is safe for use inside one's nasal passages?

Additionally, on what planet does "we should lower the recommended dosage so idiots that intentionally disregard the recommendations and double it don't destroy their livers" equate to "we should claim something to be homeopathic so it doesn't have to pass scientific muster when we make our claims as to our product's efficacy" in terms of what good or bad the FDA is doing for society?

Anonymous said...

Ben is correct. The FDA does not have our best interests at heart. It's just shy of a legal mafia. The FDA is in bed with plenty of companies and passes/approves food, drugs and other items based on the research supplied by the creator! No independent tests? If you think the FDA is looking out for you, you're the exact kind of oblivious idiot the FDA wishes we all were.

Anonymous said...

Ben is correct. The FDA does not have our best interests at heart. It's just shy of a legal mafia. The FDA is in bed with plenty of companies and passes/approves food, drugs and other items based on the research supplied by the creator! No independent tests? If you think the FDA is looking out for you, you're the exact kind of oblivious idiot the FDA wishes we all were.

Stephanie Zvan said...

Actually, Jason, Swansons just sells Zicam. Matrixx makes it.

Don, the people who care about where you're from are the people who are making up their minds about how ethical your company is. Nondisclosure doesn't look good.

As for your other comment, I'd love to see a citation on the two weeks figure you use. It doesn't match my understanding at all. Two weeks is about how long an SSRI can take to build to useful levels, not how long it's been studied.

I'm in full agreement that natural products are dangerous. Some of them do nothing. Some of them don't contain what they say they do or don't disclose their ingredients. Some of them have undisclosed side effects. That's precisely why they should be better regulated.

Jason Thibeault said...

Zicam is also not prepared like a true homeopathic remedy. Zicam’s labeling is misleading, claiming to be a “homeopathic preparation” of “1x potency” but in reality it is simply a 10% solution of zinc gluconate. Typical homeopathic remedies are much, much more dilute, often so dilute there are no molecules of the original substance left. The manufacturers of Zicam have simply adopted homeopathic nomenclature as a deceptive way to market a 10% solution of zinc gluconate without FDA oversight.

Source: Natural Center for Homeopathy *shudder*

So zinc gluconate -- the zinc supplement most often administered orally, for which there is some preliminary research suggesting that it helps shorten the duration of colds when ingested this way -- is the active ingredient. And the product doesn't even fall under the realm of homeopathy, despite the claims on the label. So, all that's left is, the makers of Zicam knew they would not pass FDA muster and lied about being homeopathic in order to slip by the FDA. Your FUD regarding the FDA is therefore justification for your having done so.

What worries me about this astroturf campaign is that, like all astroturf campaigns wherein the "commenters" are paid shills for the company they're defending, there's a chance your rebuttals will go unchallenged somewhere out there on the wide interwebs. And in that place where your self-serving arguments are not countered, those ideas may find purchase, and people will become sympathetic to your cause, and you will win hearts and minds to your side of the argument, no matter how depraved and self-serving and dangerous that argument ultimately is.

Jason Thibeault said...

Sorry Stephanie -- yes, my bad. Swanson is just astroturfing to spread uncertainty about the legitimacy of the body that is assaulting their cash cow. They are probably not even doing this with Matrixx's permission or knowledge, but they know who butters their bread, so it's still equally disgusting.

Stephanie Zvan said...

Jason, from what I see of where they're trying to take the argument, they want us to think that acetaminophen is so much worse than Zicam that their industry shouldn't be regulated at all. There's a certain theme of "It's such a pain to have to prove our health claims before we can make them" going on.

Jason Thibeault said...

Yeah, that whole "you're the best judge of what works for you and what doesn't" line doesn't work for me. I don't know about you, but I don't have time to set up a double-blind scientific study (nor the resources to find the volunteers!) for every single product that's recommended to me by doctors or (let's say) television commercials.

A really good idea for this, instead, would be to set down some guidelines, then have the companies themselves prove their claims about their product ahead of time, and submit the science to an oversight body of some sort. Then that body could examine the science, see if it is consistent with the body of knowledge humans already have, and if it passes muster, then the product is approved and can be sold. I don't know what you'd call such an administration, though, but they'd have to regulate claims over drugs and food alike, I'd think.

The whole argument is so transparent as to turn my stomach.

Don W said...

Stephanie - I agree with your point on the transparency thing, but I am trying my best to make this comment from me (my personal opinion), not from the company that provides my paycheck. There are plenty of employees here who love natural health, and take tons of vitamins, and plenty who don't. Despite working for a health company, I still have my own opinions and am trying to share them as just that.

DuWayne Brayton said...

Two weeks? Hmmm.

Bupropion (Wellbutrin) - invented 1969, patented 1974 and FDA approved in 1985.

Fluoxetine (Prozac) - initial studies began 1972, FDA approved 1987 - sold in Belgium more than a year before.

Sertraline (Zoloft) - Serious study began in 1977, FDA approved on 1991.

Two weeks my pasty beige ass.

I don't see anyone here "fully supporting" the FDA. To the contrary, I see a lot of people in the medical industry being critical of the FDA, while maintaining that it is better than nothing. Flawed oversight is far superior to none - especially given that the problems with the flawed oversight can be dealt with. A complete lack of oversight, on the other hand, is never going to "improve."

And Don, save your fucking whining about the lack of oversight for herbals that have a certain amount of efficacy. You want to see them FDA approved? All you have to do is actually prove their efficacy with the same studies that pharmaceutical companies are required to perform on drugs.

To be clear, I have used herbal medicines quite extensively in the past, because I couldn't afford to see doctors or get prescriptions filled. I have absolutely no doubts that many herbals are quite effective - they are after all, where a lot of pharmaceuticals are derived. But the notion that there is some conspiracy to keep them down is patently absurd. The last thing that the supplement industry wants to see is oversight - then they would have serious restrictions placed on sales, while being unable to actually patent anything.

There is nothing stopping anyone from actually performing the necessary studies - nothing but a virtual elimination of the profit margins.

Greg Laden said...

People need to quit relying on the FDA to tell them what is safe, because they aren't doing a great job. They do a good job, but not a great one. Vaccines, Antidepressants, and on and on, are dangerous, but fully approved because they make big money.

I'm totally with you on this. People who are smarter than the FDA should not have to listen to the FDA

OK, now, quick, name twenty distinct molecules operating in every living cell that have nothing directly to do with DNA translation or transcription.


Sorry, no looking it up in Wikipedia. You don't know what you are talking about. Rely on FDA please.

Jason Thibeault said...

"Oh, but Greg, that's such a pain, and it cuts into our profit margins. Free market rah rah rah!"

Jared said...

To Jason et al.
From what I can find, Zicam contains 266 micrograms of zinc gluconate (ZG) per spray is all I could come up with; that means 532 micrograms of ZG per dose; it's 14.35% zinc by mass, so you're looking at a zinc dose of 76.34 micrograms per dose, six times per day, you have a total of ~4800 micrograms of ZG or 350 micrograms of zinc. While this level is, in and of itself, not dangerous (human daily recommended intake of zinc is ~5-10 milligrams, not micrograms), application of zinc gluconate in this concentration directly to the nasal mucosa is what makes it dangerous. It is suggested by several authors of case studies on zinc-induced anosmia that zinc ions are toxic to olfactory epithelium.

I found a few articles related to ZG induced anosmia on pubmed going back to 2000 and earlier. A few of these are of note; one study looked at a different zinc-containing molecule and reported only mild or transient olfactory interruptions, leading me to conclude that it may not, as some have speculated, a result of the ions being toxic to the olfactory epithelium, but I did not examine the actual concentrations used, and the concentrations may be far lower than those present in Zicam. However, the fact that case studies do not have available the specific dose or ZG received, it can only be assumed the individual was following directions which may lead to potentially inaccurate data. I would argue that further research is needed to understand the olfactory receptors prior to praying high concentrations of salts onto the nasal mucosa for a potentially very small decrease in duration. Additionally, we must find a mechanism and threshold level by which Zicam causes anosmia. In short, we need more data to reach firm conclusions at this time.

Jared said...

Hey, Greg, it all comes back to DNA at some point, it also all comes back to protein or RNA synthesis, metabolism, etc. You can't separate parts of a cell and call them distinct from others. These are integrated systems. How distinct are you talking? Would you consider tubulins to be directly associated with DNA transcription/translation? I would. Similarly, I would consider cAMP-mediated signal transduction to be related to DNA transcription/translation at a very direct manner.

Stephanie Zvan said...

Jared, I don't think we need more data to reach the conclusion that people have complained about anosmia in conjunction with taking Zicam Cold or that this is consistent with what we know about the product or the behavior of zinc in the body. An exact mechanism would be cool to know about but not a reason to delay telling people not to stick this stuff up their noses.

Jared said...

Stephanie, I was just saying that we need more data to reach a firm conclusion on the effects and causes, I was not advocating its use as a treatment or "remedy." I actually think Zicam should have been pulled after the publication of the first reports back in 2004 with the publication of Jafek et al. in the Journal of Rhinology.

Stephanie Zvan said...

Thanks for clarifying, Jared.

PalMD said...

Let's not forget the risk/benefit. There is no good, consistent evidence that zinc accomplishes anything useful. There is some evidence that it may do something bad. Why bother with it at this point?

Analgesics with a favorable side effect and safety profile are few and far between. Tylenol is one of the few that has had minimal side effects and, when distributed and used properly (a problem in the US) is pretty safe.

Medicine ain't easy, and creating safe and effective treatments is a balance. Hopefully new regs will help with our tylenol problem. It won't, however, help us with the problem of treating pain.

Oh, and in case I forgot to say it...

Homeopathy??? HAHAHAHAHAHA

Jared said...

Oh, I forgot to add, for Evita, the following pertaining to humans being "intuitive" and "wise."

qetzal said...


The data I've seen suggests that the total Zn dose from Zicam may be quite a bit higher than you suggest.

The study at http://www.journals.uchicago.edu/doi/full/10.1086/324347 indicates that Zicam contains 33 mM zinc gluconate. In that study, they administered 120 microliters in each nostril, 5x per day. That works out to 2.6 mg of Zn per day - substantially more than your estimate of 0.35 mg.

What's the source for your data?

Total dose aside, it's also worth noting that 33 mM zinc is a pretty substantial concentration. IIRC, typical serum concentrations are on the order of 0.015 mM.

Jason Thibeault said...

There's a lot more grass than astroturf in here now. That's nice to see.

And the actual data that's coming out, seems to be uniformly suggesting that a) there's no absolutely known benefit to the product; b) the product contains levels of zinc that are far more concentrated than have been adequately tested for usage intra-nasally; and c) there is a lot of evidence that even small amounts of zinc used on your nasal mucous membranes is outright harmful. And the consensus, outside of the astroturfers, is that Zicam should be taken off the shelves.

Interestingly, the FDA actually ordered a recall of it, too, despite all the framing that's going on saying they just "advised against using it" or "suggested there might be a problem with it" or other such mild rebukes. So, the FDA's decision is in line with the data and the folks knowledgeable in medicine agree with the FDA. What's left? Smear the FDA and make it seem like this isn't an actual recall order.

There's a strategy I'm sure is going to work.

Jared said...

qetzal, I was relying on someone who had cited that paper, and obviously did a conversion wrong. I have redone the calculations with the 33 mM figure and I get something close to your figures. I could not access the paper directly as my browser would lock up every time I tried to view it; it does not like .pdf files when AVG is running. Thanks for pointing me to the page rather than the pdf.

Becca said...

"OK, now, quick, name twenty distinct molecules operating in every living cell that have nothing directly to do with DNA translation or transcription." DUDE. WAY TOO HARD. I started. Then I remembered about the anerobic non-photosynthetic sulfur bacteria in the bottom of the ocean feeding the tubeworms and realized I was fucked. I don't even know if they have pyruvate! Maybe I could have done it right after my advanced microbiological biochemistry class in undergrad, but I'm not sure. Couldn't you at least have had the decency to restrict it to a standard human cell?
But then, I trust the FDA for the most part.

Stephanie Zvan said...

Becca (and Jared), I think if you can do a detailed critique of the question, you pass.

Pal, thanks. There was some discussion of acetaminophen on the original thread, but it's good to have it here as well (and you did it waaay better than I did).

Dan J said...

So, according to 21 CFR 211, Subpart I - Laboratory Controls, Sec. 211.165 Testing and release for distribution:

"(a) For each batch of drug product, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release."

However, according to the FDA's Compliance Policy Guide 7132.15 (Issued: 5/31/88 Revised: 3/95), "In the Federal Register of April 1, 1983 (48 FR 14003), the Agency proposed to amend 21 CFR 211.165 to exempt homeopathic drug products from the requirement for laboratory determination of identity and strength of each active ingredient prior to release for distribution.

Pending a final rule on this exemption, this testing requirement will not be enforced for homeopathic drug products.

So, homeopathic remedies aren't even required to have laboratory testing to identify and quantify their active ingredients. The homeopaths want to be taken seriously, and want to be treated as other health care professionals, yet they still want special exemptions from the rules.


Ben Zvan said...

Dan J: It's not that they want special exemptions, it's that there's no way to determine the identity and strength of each active ingredient in a homeopathic remedy because there are none.

Ben Zvan said...

... Unless they're lying about it being homeopathic of course.

Jason Thibeault said...

My understanding is that the legal definition of homeopathy is only that a substance which normally produces the symptoms you're trying to treat, is used to "balance" the body and cure the disease. I don't know if the dissolution stuff is actually in that legal definition, looking for that now.

If this is the case, then technically just having zinc in the thing at approx 1X concentrations means you fall under the constraints of homeopathy. If the legal definition includes dissolution, and is by necessity something hugely high and therefore akin to purified water, then Matrixx are lying by putting "homeopathic" on the label just to get around the FDA.

That homeopathy gets special exemptions at all is disgusting. Not dangerous, though, if they were all by definition mostly purified water.

But now that this is in question, I have to wonder if maybe that law should be repealed and everyone should have to go through the proper scientific channels now while the iron is hot. I mean, shock doctrine worked for the Republicans, why shouldn't it work for the reasonable while the shock of Zicam's devastating effects, is still fresh on everyone's minds?

Dan J said...

The FDA's Compliance Policy Guide uses this definition for homeopathic "drugs":

"Homeopathic Drug: Any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements. The potencies of homeopathic drugs are specified in terms of dilution, i.e., 1x (1/10 dilution), 2x (1/100 dilution), etc. Homeopathic drug products must contain diluents commonly used in homeopathic pharmaceutics. Drug products containing homeopathic ingredients in combination with non-homeopathic active ingredients are not homeopathic drug products."

Notice that last sentence one more time: "Drug products containing homeopathic ingredients in combination with non-homeopathic active ingredients are not homeopathic drug products." Of course, the homeopaths are the ones who get to say what substances are homeopathic, so it's pretty much wide open for them.

DuWayne Brayton said...


They needn't call it homeopathic to legally sell it - there are a great many supplements that sold in the U.S. that aren't. What you need to grasp about their calling this shit homeopathic is that they want to get people to equate all sorts of things with homeopathic remedies, some with some level of efficacy, some that just do - something...

Efficacy by association. Back in Portland, alt-med is huge - between them, Portland and Seattle have the highest concentration of schools for alternative medicines in the U.S., probably the world. They are really big on calling it all homeopathic medicine - lump it all together to make it all as effective as it's strongest links.

And unfortunately, it seems to be working...