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Retraction Watch

Tracking retractions as a window into the scientific process

Hair today, gone tomorrow: Hair loss company retracts public statements

with 7 comments

Sorry, but we have some shocking news to report: That hair loss stock you bought may not be quite as promising as you were led to believe.

A release from Vancouver-based Replicel, which takes “dermal sheath cup cells…from a subject’s own healthy hair follicles,” replicates them “into the millions over a three month period,” and reintroduces them ” into areas of hair loss” with “the anticipated result the development of new hair follicles”:

VANCOUVER, BC – April 27, 2012 – RepliCel Life Sciences Inc. (the “Company” or “RepliCel”) (OTCBB: REPCF) today announces that it is clarifying certain disclosures which were overly promotional, misleading and inaccurate.  The disclosures were published in reports available online or delivered via email newsletter, including TheHotPennyStocks.com, hotstocked.com, StockGuru and in other disclosures published by Lake Group Media Inc., and in an equity research report published by NBT Equities Research/NBT Communications which contained certain price targets and a strong buy recommendation.  Lake Group Media Inc. and NBT Equities Research/NBT Communications were hired by the Company to build awareness.  The Company wishes to make a general retraction in respect of certain disclosures, although the Company notes such certain disclosures were not authorized by the Company.  Specifically, the Company wishes to make clear that, given the Company’s current stage of development, price targets and estimates pertaining to expected increases in the Company’s share price, as published in the aforementioned reports are premature and cannot be relied upon.  Price targets and dramatic increases in share prices indicated in such publications may never be met and there are many risks and uncertainties pertaining to the Company’s business and shares that may cause investors to lose their entire investment in the Company, including that the Company’s technology may not work as expected and, even if it does work as expected, the Company may be unable to successfully commercialize the technology or protect its intellectual property from competitors.  Other risks and uncertainties pertaining to the Company’s business are set out in the Company’s annual report, which is filed on Sedar (www.sedar.com) and Edgar (www.sec.gov).

We asked Retraction Watch friend and TheStreet.com biotech columnist Adam Feuerstein to interpret this for us, since it was a bit different from the sorts of journal retractions we usually cover:

Interesting disclosure. It appears the company hired penny-stock promoters to publicize or “pump” the company but these promoters went a bit overboard with their claims. If I had to guess, regulators started asking questions about some of the claims being made, or at a minimum, the company was worried that regulators would come a’calling. To wiggle out of the problem, Replicel is now publicly disavowing the work of the stock promoters they hired.

The retraction may have little do with the company’s actual results, if a release put out several days later is any indication:

The Company is delighted to report that the six-month interim analysis results support the continued development of DSCC for the treatment of androgenetic alopecia. “The assessment of the primary endpoint of the TS001-2009 clinical trial shows a favourable local safety profile for injections of autologous hair follicle cells,” said Darrell Panich, RepliCel’s Vice-President of Clinical Affairs.  “We are also encouraged that the early analysis of efficacy endpoints has shown a trend for improvement in hair growth parameters and a statistically significant number of participants showing a treatment response.  The results of this first-in-man trial tell us that we are on the right track in developing an effective treatment for people suffering from pattern baldness.”

We’ve asked Replicel for comment, and will update with anything we hear back.

Now if only it were this easy for us to retract our own hair loss…

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Written by ivanoransky

May 7, 2012 at 1:45 pm

7 Responses

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  1. Heheheh.
    Men with male-pattern baldness are a particularly desperate group of victims who will try almost anything. I’m surprised and amused that the company developing this method took the trouble to attempt to retract “inaccurate” statements issued on their behalf by publicists that they hired. Probably they were afraid of regulatory attention, which is a good thing.
    It is unlikely that this new method will have any effect clinically, although it may be basically sound. The nature of the stimulus that causes the alopecia will likely defeat any attempts to replenish hair follicles. It appears that high levels of dihydrotestosterone locally cause the atrophy, and any transplanted follicle cells will respond in the same way. The researchers involved in this work are probably aware of this limitation; they may be calculating that the cache of stem cells will impart enough optimism to keep their work funded to the bitter end.
    Nonetheless, a weak or partial response will be statistically significant, enough to sucker desperate bald men into trying it. Witness the success of Rogaine since it has been placed over the counter (doctors wouldn’t waste their time prescribing it and dealing with negative reports from frustrated patients.)
    Rogaine is an excellent illustration of the difference between statistically significant responses and real treatment success.
    My comment would not be complete without revealing my personal history… I was informed of a balding spot on my occiput twenty years ago along with a receding frontal area. I chose to ignore these frightening omens. Today the balding spot is still the same size. If I had used Rogaine religiously the entire time, I would have been convinced that this nostrum was responsible for saving my hair. But it wasn’t, and I didn’t, and I saved fifty dollars a month (plus the ten or fifteen minutes a day of applying it, then inspecting the area with two mirrors, etc. etc.)

    conradseitz

    May 7, 2012 at 2:17 pm

    • You are right that male hair loss is a VERY emotionally sensitive topic for many, and this does not help those that suffer from MPB. A quick look at MPB forums will tell you how desperate some of these poor guys are, many of whom are very young (late teens), which is a time when hair loss can be very difficult to deal with. That community has to deal with false hope alllllllll the time and this is just another example of it. The only genuine treatment right now is propecia, combined with Rogaine etc that you have already mentioned.

      The bottom line for stuff like this is: if it isn’t published in reputable journals, don’t believe a word of it!!!

      Dave

      May 8, 2012 at 8:04 pm

  2. You got that right. Due to the FDA interpretation, over the counter medications need not show any evidence of effectiveness, only that they are safe. Thus, there are many OTC homeopathic preparations available (people must be buying this stuff, nothing more than mislabeled water) as well as many remedies from a couple of centuries ago that are “generally recognized as safe” but never actually proven to work.
    Mercurochrome is one of the few OTC items that have been removed because of dangers (I think.)
    Propecia does work, apparently by reducing levels of dihydrotestosterone, but this causes significant side effects, as you can imagine.
    OTC baldness remedies are a golden recipe for fraud, particularly with the desperation felt by young sufferers of MPB– in severe cases they can have alopecia totalis by age 25 (Aieee!)
    So, this particular approach (stem cell replication followed by replanting) will become the latest nostrum, whether it works or not. The truth will set you free, but first it will make you miserable.

    Conrad T Seitz MD

    May 8, 2012 at 8:48 pm

    • In reply to conradseitz May 7, 2012 at 2:17 pm
      “Men with male-pattern baldness are a particularly” rich.
      Is male pattern baldness a disease apart from the fact that it leads to people becoming parted from their money? Perhaps it is Keynsian boost the economy needs.

      Marco Berns

      May 9, 2012 at 6:54 am

      • I don’t know of any relationship between male pattern baldness and prosperity, but…
        and no, it’s really not a disease, more like a feature of life; I have no explanation for why it should exist in an evolutionary sense. Any one care to explain the survival advantage of baldness?

        Conrad T Seitz MD

        May 9, 2012 at 3:32 pm

      • In all seriousness, it may be just an unintended side-effect of increased levels of testosteron. MPB may thus be a visual symptom of high levels of testosteron, and thus attract females, which may in turn have led to a survival advantage of those individuals that have MPB; ultimately this can even be unrelated to the comparative testosteron levels of individuals with MPB.

        Bit of a chicken-and-egg story, so expect some evolutionary biologists to vehemently disagree with me, and others nodding in agreement.

        Marco

        May 12, 2012 at 3:43 am

  3. Survival Advantage of Baldness: In a hunter-gatherer tribe, where females synchronize their menstruation with the full moon, the males know exceedingly well when they should organize a hunt. On this outing, the wisest man leads. With the full moon reflecting on his hairless head, the followers in the hunt can see their leader most clearly, even from a distance. The tribe thus has an evolutionary advantage. Baldness in women, of course, does not convey a similar leg-up.

    Geosota

    May 11, 2012 at 7:51 pm


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