Sunday, July 31, 2005

Pharmaceutical Advice on the Internet

After writing my last serious post, I got to thinking about the issue of Pharmaceutical Advice on the Internet.  Although the issue of direct-to-consumer advertising (DTCA) by pharmaceutical companies is a big issue, too, it seems to be more widely discussed.  I haven't run across much that deals specifically with pharmaceutical sales and advice over the Internet, even though that is a much more serious problem.  At least DTCA is regulated by the FDA, whereas there is absolutely no regulation on the Internet, other than on the sites put up by the drug companies themselves.  

In this post, I cast a skeptical look at Pharmaceutical Advice on the Internet, and conclude with some advice, including pointers on how to spot pseudoscientific nonsense.

To put this in context: I first became aware of the seriousness of this problem, when using the Internet in a clinical context.  Several years ago, I had admitted a patient to the hospital; the patient seemed cognitively impaired, but the usual medical workup turned up nothing.  The following day, the patient admitted to heavy use of GHB.  In fact, the patient's spouse was making the stuff in the basement, and selling it.  Both of them started using it.  Having virtually unlimited access, they got pretty badly messed up.  The patient was going into withdrawal, resulting in one of the most striking cases of human misery I have ever seen.  

In an effort to help, I started looking around on the Internet.  I encountered a site that touted the "benefits" of this "natural substance."  There was a lot of scientifically accurate information about the structure, pharmacokinetics, and synthesis of the compound.  There were many references to valid primary sources of information.  There also was a lot of apparently-accurate information about the pharmacodynamics of the drug.  But when I looked at other, more authoritative sources, I learned that there really was not a lot of empirical data about the mechanism of action of GHB.  What the author had done, was to interdigitate fact with pseudoscience.  If you checked only the first few references, you might have gotten the impression that the rest of the references were valid.  That was not the case.  If you spot-checked, you may or may not have realized what the author was doing.

The fact is, there are some valid uses for GHB.  The pharmaceutical-grade product, Xyrem, is used for narcolepsy.  There is preliminary evidence that it might be useful for fibromyalgia, as well.  (It is the most tightly-controlled legitimate drug on the market, which whould tell you something.)  Thus, if an unscrupulous webmaster wants to sprinkle her or his site with references to peer-reviewed journals, there is plenty of fodder out there.  References to valid medical journals may make a site seem authoritative, but do not provide any real assurance of validity.

I cannot find the site that I found several years ago, but there is a similar one here (International Antiaging Systems).  Note that the page has eleven citations for peer-reviewed scientific articles and one for a patent application.  Note also that the most recent reference is from 1997.  In the field of neuroscience, 1997 is practically paleontological.  What is particularly irritating, though, is that the section labeled "Long-term Studies" refers to a study by "Dr. Michael Farley," yet there are no citations in the "References" section for any articles by Michael Farley.  If a person were considering using GHB, one of the first things he or she would want to know would be the long-term safety of the drug.  You see a chart with numbers, and lots of jargon...
Farley noted elevations of growth hormone and IGF1, and reductions in blood sugar in all subjects. However, those who had not previously used GBL had higher levels of growth hormone and IGF1, and greater reductions in blood sugar than the "experienced" GBL users. For example, the average increase from baseline to a peak at 60 minutes ranged from 0.56 to 7.1 NG/ML for the seven GBL "non-users." The four subjects who used GBL for over one year had average values of 0.5 to 2.4 NG/ML, respectively.
...but you have no way of finding the original source material.  That should be a huge red flag, signaling a credibility problem.

(Note: GBL is the precursor to GBH; it is converted into GHB in the stomach.)

There is an even more subtle danger when it comes to scientific references.  Some journal articles actually are written pretty well, and thus may seem comprehensible to the nonprofessional reader.  But if you do not have specific education in the interpretation of scientific reports, you very easily could end up drawing false conclusions.  A crafty webmaster could prime the unsuspecting reader to jump to a certain conclusion, when in fact that conclusion is not supported by the literature.

There's another clue that the site is bogus.  The site, International Antiaging Systems (IAS), purports to sell "antiaging" products.  Xyrem is marketed as a drug for narcolepsy, which is a small market.  Think about it for a moment.  If the company, Orphan Medical, had sufficient evidence that their product had antiaging properties, wouldn't there be a rather powerful motivation for them to sell to that market instead?  The fact that they do not do so, is prima facie evidence that the drug has not been proven to have antiaging properties.

What about the author?  Ward Dean, MD, graduated from Han Yang University College of Medicine in Seoul, Korea.  In his bio, he does not say where he did his residency, which is odd.  The nature and location of his postgraduate training, if any, would be a better indicator of his qualifications.  He is or has been affiliated with the Cognitive Enhancement Research Institute, and the Center for Bio-Gerontology, which appears to have no website.  I was not able to find any credible evidence that would indicate that either CERI or CBG is a legitimate medical institution.  He also is or was affiliated with the American Academy of Anti-Aging Medicine (A4M).  Although they claim to be "at the forefront of a major movement," and state that trier second annual conference (1994) was "a landmark event in the progression of anti-aging medicine as a mainstream clinical science," the last item on their "Calandar [sic] of Events" was the "3rd Annual Conference on Anti-Aging Medicine and Biomedical Technology."  Apparently, they can't boast about any "landmark events" in the past ten years.

Let's look at another example: SexandDrugs.info.  The reason for choosing this one is obvious, it deals with everyone's favorite subject: dopamine.  SexandDrugs.info happens to be a target-rich environment for the skeptic, but I will focus on one area: their touting of the drug, cabergoline (Dostinex®).  Dostinex® is sold by Pfizer for the treatment of hyperprolactinemia.  By mimicking the action of dopamine, it lowers the pituitary secretion of prolactin.

Again, we see jargon:
Prolactin is a single-chain protein hormone, closely related to growth hormone, that stimulates the secretion of milk of women. The hormone also has the effect of reducing a man’s desire for more sex by preventing new erections. Cabergoline has been found to to minimize the effects of the hormone prolactin, which is produced by men at the point of orgasm. As a result, some subjects who tried the drug found that they were able to have multiple orgasms in rapid succession.
We also see references to scientific studies:
In one study, 60 subjects, all healthy males, between the ages of 22 and 31, normally needed a break of 19 minutes between lovemaking sessions. However, after taking Cabergoline, they were able to have several orgasms within a few minutes. Medical psychologist Manfred Schedlowski, who was involved in the trials at Essen in Germany, said the drug raised the libido to enable the male to orgasm again more quickly.
The author breaks with tradition, though, and does not include any formal citations to medical journals.  Again, we see information that has face validity, but we have no way of checking for content validity.  the author does provide a link to a BBC News article, but that doesn't really help.  It does show that he knows how to link to articles, though, so it raises the question: why is there no link to a primary source?

Are there other clues about the bogusness of the site?  Of course.  Pfizer is a reputable company, but they are know to be aggressive in finding markets for their products.  Hyperprolactinemia is not a big market.  Sexual performance enhancement certainly would be more lucrative, but it is not a market they have pursued.  Why not?

More clues?  The author of the site, apparently, is David jay Brown.  
David Jay Brown holds a master's degree in psychobiology from New York University (1986), and a B.A. in psychology from the University of Southern California (1983). He is the author of two science fiction novels, Brainchild (New Falcon, 1988) and Virus (New Falcon, 1999), and is co-author of two volumes of interviews with leading-edge scientists and artists--Mavericks of the Mind (Crossing Press, 1993) and Voices from The Edge (Crossing Press, 1995). David's interviews have been translated into Japanese (Hachiman, 1995), Italian (Gruppo Futura, 1997), and Czechoslovakian (East Hauz, 1999). He was responsible for the California-based research in two of British biologist Rupert Sheldrake's books on unexplained phenomena in science: Dogs That Know When Their Owners Are Coming Home (Crown, 1999), which was the bestselling science book in the world for several weeks in the Fall of 2000, and The Sense of Being Stared At (Crown, 2003).
Not to be elitist or anything, but a Master's degree is not really adequate preparation for psychopharmacology.  I see several publications, but none that would impress a tenure committee.  

Check all the links on the page.  For example, SexandDrugs.info links to this.  Personally, I do not think that lends much credibility.

The final clue, of course, is in the left sidebar: "Quick Links to Purchase..."  Examining the page source (view:page source, control-U in Firefox) we see that the link to purchase Dostinex goes to:
The way this works, is that the owner of the page that refers a customer gets a percentage of the sale.  See this page for an explanation of World Remedium's "affiliate program," which, by the way offers this claim: "Our payout is one of the most generous in this industry!"  So the more persuasive the webmaster can make the pitch for the product, the more money she or he can make.  Presumably, the link contains some identifier that enables World Remedium to tell where the money is supposed to go.  So who's Joseph Wouk?  

This, in and of itself, is not necessarily a shady practice.  There are lots of blogs that have links to books at Amazon, etc., and the blogger gets a cut.  Most of those are perfectly fine blogs, and I have no beef with them.  But if the sole purpose of a site is to generate money, you really do have to wonder about the webmaster's motivation to stick to the truth.  

Think of it this way: if you went to the online version of the New England Journal of Medicine and read A Comparison of Cabergoline and Bromocriptine in the Treatment of Hyperprolactinemic Amenorrhea, you might get the impression that cabergoline is a good medicine, and you would assume that the authors were telling the truth.  But if, at the bottom of the page, you saw a link that would let you buy the stuff from an anonymous pharmacy somewhere, and you knew that the author got 15% of the sale, would you still trust the article?  If so, I have just the product for you:

So what did we just learn about Pharmaceutical Advice on the Internet?  
  • The inclusion of jargon and scientific references is no assurance of content validity
  • It is important to check the author's credentials, and to remember that you can't really be sure who the author is
  • Look for the interweaving of verifiable facts with unsupported claims
  • Check ALL the references aand all the links
  • View the page source to see where the links go; the text in the status bar may be misleading, and mouseover information can be changed.  
  • If you are not a scientist, be careful when trying to interpret scientific reports.  
  • Always find out who is making money off the deal
  • If a product is claimed to have wonderful properties, but the legitimate manufacturer makes no such claims, you have to wonder why not.
  • Look for recent references.  If everything is over five years old, that's a bad sign.  
And what about GHB?  It's highly dangerous; don't use it unless you have polysomnographically-confirmed narcolepsy (including MSLT), or maybe severe fibromyalgia.  Cabergoline?  Fine for hyperprolactinemia; forget it for sexual enhancement.  Read the FDA Safety Guides.  And, as always, DON'T buy drugs over the Internet!

Categories: Science, medicine
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