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.
Whether Akeso's "cocktail" combination of ingredients will work to give Alzheimer patients some relief is yet to be determined. NCCAM was skeptical at first too, and turned down their original application, but they finally did agree to give Akeso a shot with a small grant to show feasibility of their premise. We'll see...
ReplyDeleteBut your attack on the SBIR program is unwarranted. In the early 1980s Congress passed the Small Business Innovation Development Act to require large Federal agencies who do R&D to dedicate a small percentage of their R&D budget to funding innovative approaches to solving tough problems. Literally thousands of small companies have received their initial seed funding through these awards. It's a very competitive process with only around 10-15% of the applications being selected for awards. For a short description of the program, see http://www.fedmarket.com/articles/sbir-program-federal-contracting.shtml.
You can examine the full scope of the Program (including a database of award recipients) at the SBIR Gateway (www.sbirgateway.com).
As The SBIR Coach, I've been helping companies navigate the complex process of applying for awards and commercializing the resulting technology that they develop for 20 years. I'm not a scammer. I've helped many companies (including two of my own) bring innovative technology from just an idea all the way through development to the marketplace -- a process that truly would not have happened for them without the opportunity provided by SBIR. And it is a game, one with complex rules, stiff competition for the limited funding, and strategies for giving your proposal a competitive advantage for receiving a high rating with the panel of scientists and engineers who do the reviews.
Whether you like the SBIR Program or not, now's your chance to put your two cents in where it can matter, as the Senate is currently considering a re-authorization bill. The House has already passed its version (H.R.5819). But, before you attack something you know little about, please take a thorough look and examine what's really happened over the 25+ years the program has been in existence. Draw your own conclusions, but do some research first, and base them on facts, not suppositions.
I know plenty about SBIRs - I've served on NIH review panels that have evaluated these applications. As I wrote, this is a long topic, probably for another blogpost sometime. But I stand by my comments - the SBIR program is largely a waste of money. Sure, the program only funds a small percentage of the applications - but most of the applications are, frankly, very poor. The quality is far lower than NIH research grant applications (and I've served on many review panels for those too).
ReplyDeleteI'm aware of the re-authorization pending before Congress, and I've also heard that some lobbyists want to increase SBIR funding, which I think would be a terrible idea.
Look, the government wastes money in many ways, and if Congress wants to promote small business, fine. But don't earmark a fixed percentage of funding from NIH, NSF, and other federal agencies (which is how the SBIR program gets its money). That is stealing precious - and very limited - funding from scientific research for another purpose, and it hurts the science. Arguing that it's only a small percentage - and that's the argument I've seen, many times - is doesn't wash.
Sooooooo, what was the preliminary data for this grant?? It had to have something....right???
ReplyDeletesigh.
Rhea - good question, but unfortunately there is no requirement for preliminary data for an R43 grant. (An R01 grant - the NIH standard - does require preliminary data.)
ReplyDeleteThey might have had some data, though - but the NIH grants database only makes a summary (abstract) available. The complete proposal is not available publicly.
YaY!! thats exactly what i wanted to hear!!
ReplyDeleteI was also thinking about the "competitive" percentages of R43's last night...
So I would ASSume that there are fewer applications for R43 grants than for, ummmm, lets say, RO1's. For arguments sake, lets say 10 proposals were sent in for a R43. Then, to get 10% of applications accepted only 1 outta 10 would need to be awarded. So now, compare that to the number of RO1 proposals that are sent in...lets make that number 100,000 (again just for the point)...and set a higher %age of acceptance rate, 20% lets say. Then, you will get a total of 80,000 proposals that were shot down compared to 9.
Not only would the quality of the grants applications themselves have to be poor (as you phrased it) to get one like this one accepted...but there also wouldn't be much competition (according to my ASSumption) to nudge ones from Vitamin companies out.
I, personally, like the idea of having money set aside for small businesses and other random area's of research because otherwise innovative ideas might never see the light of day. However, I do think each program should be just as competitive...and not just in that only "10%" are awarded...but competitive in that they could stand up to RO1 applications as well (they are just more likely to get funded).