Saturday, April 16, 2011

Neuroaid: Partial Truth and Petty Theft









Bottom line
  • Neuroaid is a drug that is made from traditional Chinese herbs.
  • Cost: $1,346
  • Effectiveness: The company says it works. The research disagrees.
Amendment: August 12, 2013: A well run clinical trial using 1000+ participants showed neuroaid "...is statistically no better than placebo in improving outcomes." Find the results here.

(Thank you Ali Hussain Ali).
Neuroaid has long been an easy joke among neurologists, physiatrists and researchers. Here is an actual email:

Colleagues:

It looks like millions of lives will be restored. How absent minded of me to tell patients that there is no “magic bullet” for all of these years…and shame on you therapists and physicians for not giving the below to your patients. Thank goodness for Neuroaid.

I really had no opinion about it because on the face the claims seemed dubious so I never took the time to unpack the research.

But that all changed when neuroaid decided to call their blog The Stroke Recovery Blog (TSRB). They did this in 2010. It is true: You cannot copyright a blog name, especially not one with a generic name like TSRB. But they picked this name for a reason: It is an established name in stroke blogs, has been around since 2008 and is generally respected. ("So when folks look for that blog, they'll find our blog- We are geniuses!")

(Amendment: June 25 2021: neuroaid no longer has a blog called The Stroke recovery Blog.  There's still a blog, which appears to be written by a non-native English speaker, which has no name. You can find it here.)

In any case, their choosing to steal this blog's name made me realize that the company that makes neuroaid may not be completely truthful.

So I did a bit of investigation....

There are several problems with their research.
  • There is an obvious conflict of interest with regard to many of the folks involved in the research. That is, the people who are doing the research work for the company. This is bad, and it happens all the time. The profit motive may (or may not) sway the researchers to "massage the data" so that the data suggests that the product is AWESOME!!! 
  • Consider Marie Germaine Bousser of neuroaid's scientific advisory board. She is also one of the researchers of the product (last author). The same is true with others on neuoraid's scientific advisory board. Here's my question...how do they get away with that? The lab I work in does trials of products all the time but we have to sign conflict of interest forms that clearly separate us from the product tested. A lab can get itself in trouble  (and often through sheer osmosis, other labs at the same and related universities) when you get paid for your "research." (If you want a nerdy take on this issue, click here.) There are a 55 studies on neuroaid that show up in Medline
  • Addendum: 12.15.2020?: Here is a synopsis of the first 16 neuroaid studies on PubMed: 
    • Rodent models: 4.
    • Announcement of a trial: 4. At least one is run by the company that makes neuroaid
    • Human trial: 4. 1: "There were no significant differences between the groups for neurobehavioral sequelae, mood, fatigue, physical disability or overall quality of life at 6 months. No serious adverse events were reported." 2: CHIMES Trial: Moleac, the maker of neuroaid "provided grants" for the study. 3: Among women, there was a trend for a higher proportion with good functional outcome with NeuroAiD versus placebo. There was no treatment difference between NeuroAiD versus placebo in men. 4: neuroaid did not adversely effect BP, renal, liver, blood.
    • Systematic review: 1. probably the most compelling article suggesting efficacy (2013). reviewed six studies. "our review reveals that there is some evidence that MLC601 as an add-on to standard treatment could be effective in further improving functional independence and motor recovery and is safe for patients with primarily nonacute stable stroke." Perthe CHIMES study: In conclusion, while the benefits of a 3-month treatment with MLC601 did not reach statistical significance for the primary endpoint at 2 years, the odds of achieving functional independence defined as mRS ≤1 at 6 months was significantly increased and persisted up to 18 months after a stroke
    • Letter to the editor: 1. (2008)
    • Pharmacogenomic profile: 2. 1: human neuroblastoma cell line SH-SY5Y was used. 2: I completely did not understand the study, very complicated and chemical.
  • Addendum 6.7.15: Interesting note: The study in which neuroaid has touted, called the CHIMES-E study, is thick with conflicts. First, at least 2 of the authors are on neuroaid's scientific board. Further (you can't make this stuff up) neuroaid's parent company "... provided grants to the CHIMES Society of which the society had sole discretion on use." And, uh, one of the authors owns stock in neuroaid's distributor. And, the name of that distributor? E*Chimes! Has a ring to it!
  • Neuroaid is made with "12 different Chinese herbs plus extracts of leech and scorpion." that are probably available in any Chinese drug store in any major American or European city. You can also buy some of them online. Here's one on Amazon. Here is another herb called "Strokaway." Here are more. Scorpion venom here. 
  • (Have a look at Mike's take on this in the comments section link at the bottom of this post for more info on obtaining the drug in alternative ways. Thanks Mike!) 
  • According to their site "...the price for NeuroAiD .... One month of treatment is US $488, including shipping fees. The standard 3-month treatment costs US$1,346 including shipping fees."
  • The main way of measuring the drug in their biggest clinical trail was something called the "Comprehensive Function Score component of the Diagnostic Therapeutic Effects of Apoplexy." Stroke specific outcome measures is my area. Since the late 90s I've done all kinds of tests of recovery from stroke. I've never heard of the the test they use. And there is no way to research it. Medline has no mention of it. Google only produces results that reference guess who? (Apoplexy is a term that has not been used to describe stroke since Andy Griffith!)
  • Neuroaid claims it increases BDNF, a protein in the brain that helps recovery from stroke. As with many of their claims, there is a grain of truth here. They did find an increase of BDNF in one French rodent study.
  • "Alternative medicine that works is called medicine." I think my colleague's email, in blue above, suggests the primary problem. If neuroaid had reached the level of evidence that neuroaid claims then why would MDs not suggest it's use? Because MDs don't want people to recover because....uh...
  • NOTE: I don't know this drug does not work. But by any stretch, the evidence is thin. 
Bottom line:  
  • A company makes strident claims with little research to back it up.
  • Company's PR firm decides to hijack "hits" from  this blog to their profitable website disguised as a blog.  
  • Reference articles 


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