NCCAM is funding quack vitamin cures

It's been a while since I looked at what the National Center on Complementary and Alternative Medicine (NCCAM) is spending our tax dollars on, so I took at look and found a newly funded proposal (grant R43AT003025) called "Medical Food Cocktail for Alzheimer's Disease." The title raised suspicions right away - what the heck is a medical food cocktail, and why would it help treat Alzheimer's? Is it some new miracle treatment? I was skeptical - after all, this is NCCAM, the NIH center dedicated to wasting our valuable research funds on bad science.

A second red flag was raised by the official email address of the Principal Investigator (PI), Curt Hendrix - rather than a university or a company, his address is a personal email account. Very strange. So what is the study going to do? From the NIH website, we find that

The overall goal ... is to formulate and conduct initial feasibility tests of a medical food cocktail composed of standardized herbal extracts, vitamins, and minerals that are demonstrated in the basic science and clinical medical literature to impact the biochemical and pathophysiological processes involved in Alzheimer's Disease. The first Specific Aim will be to formulate and standardize the cocktail, which will include extracts of tumeric, green tea, black pepper and vitamins and other nutritive ingredients.

Once they formulate this cocktail, they'll test it on mice. What? Tumeric, green tea, black pepper, and vitamins will cure Alzheimer's? That would be great if it were true, but there's no evidence to support it. (And if it were true, we'd have sub-populations of humans that had very low Alzheimer's rates, since these are common components of many people's diets.)

So who is the company that NCCAM has given this award to? It's Akeso Health Sciences, LLC, in Westlake Village, California. I've never heard of them, so I did some quick checking. It only took a few minutes to find that Akeso is another name (or a front) for a company called Migrelief that sells vitamin supplements: http://www.migrelief.com. ("Migraine relief," get it?) They used to call themselves MigraHealth, and they sell vitamin supplements that they claim help cure migraines.

Akeso Health Sciences is also quoted in a testimonial on a website called The SBIR Coach, a company that helps other companies win NIH grants. Their motto - prominently posted at the top of their website - is "We know this game." That's right, they teach companies how to play the "game" and win small business grants (called SBIRs) from the federal government. So we have one scammer (SBIR Coach) helping out another (Migrelief, also known as Akeso Health Sciences) to get funding from NIH.

How can a purveyor of vitamins for migraines re-brand themselves and get NIH money? That's what happened here: Migrelief used their alter ego, Akeso Health Sciences (sounds like they do science, right?) and wrote a proposal to NCCAM. Because NCCAM has far lower standards than the rest of NIH, and because their mission includes the promotion of pseudoscience, they funded this ridiculous proposal. What a colossal waste of funds. And I can imagine that Migrelief will soon be selling their supplements to Alzheimer's patients, offering them false hope of a cure so they can make a fast buck.

NCCAM should be closed down. Any scientific proposal worthy of funding should have to go through one of the legitimate NIH institutes. And while we're at it, we should shut down the SBIR program too; that'll have to be the subject of a future blog.

Chocolate genome sequenced - verrrry slowly

I read in the Washington Post yesterday - on the front page, no less - that the chocolate genome (the genome of the cacao plant) was going to be sequenced, with most of the funding coming from the Mars chocolate company. But then I saw on CNN the headline "Scientists analyze chocolate genome." Huh? So it's already done? Well, no - this is science by press release (as opposed to real science). No one sequenced the chocolate genome - not even a small part of it. All the news stories are based on press releases from Mars and IBM (which is collaborating with Mars on the project). The NY Times reported it with the headline, "A Genetic Quest for Better Chocolate."

Well, okay, I suppose it's interesting cocktail-party talk that someone is working on the chocolate genome. But all these dramatic news stories don't amount to much news at all, at least not on the scientific front, since nothing has been done yet. I guess the science reporters were too busy to find some real science to report on, and it's so easy to take this press release from Mars, Inc. and turn it into a story. Good job, people!

One strange element is this: "The group anticipates that it will take approximately five years to complete the entire sequencing, assembly, annotation and study of the cocoa genome." What? The genome is only 500 million bases (DNA letters). These days, a genome of that size can easily be sequenced in one year; in fact, I'm working on two species, each twice as large, that we're planning to sequence in less than a year each. This raises suspicions that they will be doing something else with the data during all that time - though they claim they will make the intellectual property freely available through PIPRA, the Public Intellectual Property Resource for Agriculture.

We should keep an eye on this and see if they really deliver. But five years? That is way too long.

Another drug maker paying for scientific articles

About a week ago I saw the full-page ad in the Washington Post by Pfizer for its drug Chantix. The ad didn’t say what Chantix was for (it supposedly helps people quit smoking); instead, it was a statement by Pfizer reassuring patients who take Chantix that everything was okay. There was some verbiage about how careful Pfizer is to ensure the safety of its drugs and that no one need worry. Obviously something wasn’t okay.

A quick web search revealed that Chantix is causing some very bad side effects: heart problems, seizures, diabetes, and over 100 vehicle accidents linked to the drug. (See the Wall St. Journal article by Alicia Mundy and Avery Johnson, May 29, 2008.) After my recent blog on Merck and Vioxx, discussing how Merck paid for scientific articles about Vioxx and then got outside scientists to put their names on them (the Vioxx Wall of Shame) , I wondered if Pfizer had done something similar for Chantix.

Well, they did.

I jumped over to PubMed and searched for articles on varenicline, the generic name for Chantix. I found many articles, some of which were exactly what I suspected: articles promoting the use of Chantix as safe that were paid for by Pfizer, but whose authors were not Pfizer employees. Let’s look at a few:

Nides M, Oncken C, Gonzales D, Rennard S, Watsky EJ, Anziano R, Reeves KR.
Smoking cessation with varenicline, a selective alpha4beta2 nicotinic receptor partial agonist: results from a 7-week, randomized, placebo- and bupropion-controlled trial with 1-year follow-up. Arch Intern Med. 2006 Aug 14-28;166(15):1561-8.

The lead author, Mitchell Nides, works for Los Angeles Clinical Trials, a company that runs trials for a fee. The article discloses at the end that Pfizer paid for the entire trial. Oncken is at the Univ. of Connecticut, Gonzales at the Univ of Oregon, and Rennard at the Univ. of Nebraska. The last 3 authors – Watsky, Anziano, Reeves – are Pfizer employees. All three of the university authors have been paid by Pfizer – as consultants, grantees, and/or speakers. Not surprisingly, this article concludes that “Varenicline was well tolerated and may provide a novel therapy to aid smoking cessation.”

The same issue of Arch Intern Med has another article by many of the same authors, concludes that “Varenicline tartrate is efficacious for smoking cessation.” On this one, Dr. Oncken is now first author, which means Pfizer can say that this study was led by the Univ. of Connecticut:

Cheryl Oncken, D Gonzales, M Nides, S Rennard, E Watsky, CB Billing, R Anziano, K Reeves; for the Varenicline Study Group. Efficacy and Safety of the Novel Selective Nicotinic Acetylcholine Receptor Partial Agonist, Varenicline, for Smoking Cessation. Arch Intern Med, Aug 14/28, 2006; 166: 1571 - 1577.

If you go to the end of the article, you learn that all the authors are in the pocket of Pfizer. Here’s what it says about just the first two authors: “Dr Oncken has received research grants, consulting fees, and honoraria from Pfizer; nicotine replacement and placebo products from GlaxoSmithKline at no cost for smoking cessation studies; and honoraria from Pri-Med. Dr Gonzales has received research contracts, consulting fees, and honoraria from Pfizer.”

Here are two more articles by LA Clinical Trials:

Nides M, Glover ED, Reus VI, Christen AG, Make BJ, Billing CB, Williams KE.
Nides again, and LA Clinical trials. Varenicline Versus Bupropion SR or Placebo for Smoking Cessation: A Pooled Analysis. Am J Health Behav. 2008 Nov-Dec;32(6):664-75.

Mitchell Nides M. Update on pharmacologic options for smoking cessation treatment. Americal Journal of Medicine 2008 Apr;121(4 Suppl 1):S20-31.

They’ve been busy! (Guess how well Chantix/Varenicline fared?) But Pfizer can’t just use this unknown company – they also recruited much more prestigious institutes, such as the Mayo Clinic:

J. Taylor Hays, Jon O. Ebbert, and Amit Sood. Efficacy and Safety of Varenicline for Smoking Cessation. American Journal of Medicine 2008 Apr;121(4 Suppl 1):S32-42.

The lead author – Hays – is at the Mayo Clinic in Rochester, Minnesota. But if you go to the end of the article, you find that “J. Taylor Hays, MD, has served as an unpaid consultant on an advisory board for Pfizer Inc; and has received grant/research support from Pfizer Inc. But get this: “Editorial support was provided by Darlene Benson, BSPharm, of Medesta Publications Group, and funded by Pfizer Inc.” I strongly suspect that Ms. Benson may have written part of this article. Another example of doctors basically selling their names to a drug company for the financial benefit of both. The Mayo clinic should be ashamed.

There are many more, for example this article on Chantix:

D F Heitjan, D A Asch, Riju Ray, M Rukstalis, F Patterson, and C Lerman. Cost-effectiveness of pharmacogenetic testing to tailor smoking-cessation treatment. Pharmacogenomics J. 2008 Mar 18.

These authors are at the University of Pennsylvania, and the senior (last) author was paid by Pfizer: “Dr Lerman has served as a consultant to Glaxo Smith-Kline, who provided bupropion and placebo for the studies described. She has also served as a consultant for Pfizer and has received funding for a project unrelated to the data presented in this paper.”

Pfizer also paid a group at Lund University (Sweden) to show that their drug was better than their competitors:

Kristian Bolina, Ann-Christin Mörk, Stefan Willers, and Björn Lindgren. Varenicline as compared to bupropion in smoking-cessation therapy—Cost–utility results for Sweden 2003. Respiratory Medicine 102:5, May 2008, 699-710.

The paper reveals that “this research was sponsored by Pfizer AB, Sweden. Kristian Bolin, Stefan Willers, and Björn Lindgren [at Lund University], were funded by Pfizer AB, Sweden, in connection with the development of this manuscript. Ann-Christin Mörk is an employee of Pfizer AB, Sollentuna, Sweden.”

There are many more, but I hope this list more than makes my point. Even one bad article pollutes the literature – but the drug companies don’t take chances. They pay for multiple studies that show the results they want. When Pfizer doesn’t pay, you get articles like this one:

Kristensen PL, Pedersen-Bjergaard U, Thorsteinsson B. Varenicline may trigger severe hypoglycaemia in Type 1 diabetes. Diabet Med. 2008 May;25(5):625-6.

The title says enough here – Chantix can be deadly to diabetics.

These are only a small sample – there are many more articles, but my institution (U. Maryland) doesn’t have subscriptions to all these journals, so I’d have to pay to read them. Without paying, I can’t find out the author affiliations and I can’t look at the end of the article to see if they disclosed any financial relationships. But I saw enough: just like Merck’s behavior with Vioxx, Pfizer paid to have articles published in the peer-reviewed literature that demonstrated the results they wanted.

The scientists who put their names on these articles aren’t independent – they are tools of their sponsors, the drug companies. But many of these articles don’t hide the affiliation with Pfizer, so there is more blame to go around. The journals should be held accountable: for example, why is Archives of Internal Medicine publishing studies run by LA Clinical Trials, which apparently is happy to run studies that produce the results a sponsor wants? Archives is a highly reputable journal (or at least I thought so) run by the American Medical Association.

I’m beginning to think that we can’t trust anything we hear about a new drug unless we read the original literature, and scan the literature with a highly critical eye for conflicts of interest. This is truly unfortunate. Most people don’t have the training (or the time!) to read these original articles, and very few non-academics have subscriptions to these journals. Even the experts tend to rely on the short abstracts (which summarize the conclusions), especially in reputable journals, but it appears that we can’t trust those either.

Money seems to have corrupted the biomedical literature, more deeply than I had realized. We need to work to correct this situation, starting by pointing it out wherever we see it. And before taking any new medication, I plan to dig into the literature to find out if the benefits are real, and if there are harmful side effects that the drug manufacturers have attempted to hide. Meanwhile, shame on Pfizer and on all the so-called scientists listed above who took Pfizer’s money to write articles promoting its drug Chantix.