Caveat Emptor! Blood Pressure Drug Marketed as a “Homeopathic Topical Treatment”
Written by Daniel W. Mruzek, PhD, BCBA
The marketing of a drug called Respen-A™ provides an opportunity to illustrate how we can watch for the "red flags" of unsubstantiated autism treatments.
The marketers of the drug are Elaine DeLack, RN and Kurt N. Woeller, D.O. Their business, Neuro-Med, is connected to another business called MedDev that is housed in the Gateway Centre business complex in Stanwood, WA. The marketers also maintain a Respen-A™ website (see http://www.respen-a.com/). They strongly suggest positive results with Respen-A™, a drug administered to persons with autism through a transdermal patch. On their Respen-A™ "Frequently Asked Questions" web page, the marketers state: "Many parents are reporting in the first month of using the Respen-A™, increased concentration, better eye contact, more socialization, less irritability, decreased anxiety, and some children who were unable to speak are now trying to verbally communicate once again" (see http://www.respen-a.com/respen-a-faq.html).
According to the marketers, the active ingredient in Respen-A™ is reserpine. The National Center for Biotechnology Information (2011) reports that reserpine is in a class of medications called rauwolfia alkaloids. It works by reducing the activity of the nervous system, causing the heartbeat to slow and the blood vessels to relax. Reserpine is used to treat high blood pressure, as well as severe agitation in persons with mental health disorders.
The Respen-A™ marketers hypothesize autism is caused by a "cocktail" of drugs given to mothers who use epidurals for pain management during birthing. To support this assertion, they note the positive correlation between the use of epidurals in the United States and the increased prevalence of autism. Regular readers of Science in Autism Treatment know that a correlation between two events does not mean that one causes the other. Consider the positive correlation one might find in a particular community park between the number of ice cream cones sold and the number of children who have playground accidents. As ice cream sales rise, the number of accidents rises as well; however, does ice cream cause accidents? This is doubtful. Rather, both variables are affected by other variables (e.g., temperature; on warm days, more children are in the park, increasing both ice cream sales and opportunities for accidents). Similarly, epidurals and the diagnosis of autism have both increased in recent years; however, has one caused the other? It would seem much more likely that change in health care practices in recent years may account for increased access to epidurals for mothers and much greater attention given to the early identification of autism in children.
The marketers further propose that Respen-A™ helps to correct resultant neurological problems leading to autism in children by decreasing the presence of serotonin in the autistic brain. Parents need a prescription for the drug, and the Respen-A™ marketers provide a list on their website of five pharmacies that can fill this prescription. A 28-day supply of Respen-A™ costs $82.00. A daily calcium supplement must accompany the drug due to calcium depletion as a possible side-effect.
What proof do the marketers offer regarding the effectiveness of their drug? They offer up a "Respen-A™ Video Testimonial Series" with comparisons of a boy’s behavior, including communication skills, on and off the drug. Hawkers of unsubstantiated treatments often rely on testimonials as a standard tactic for suggesting beneficial results with their product. Indeed, testimonials can provide the illusion of efficacy by providing a biased but compelling example of purported positive outcomes. But, testimonials are a far cry from scientific evidence published in peer-reviewed journals.
The Respen-A™ marketers include a table with a bar graph representing "Average Change in ATEC Score After One-Month on Respen-A" on their website. (The ATEC is a brief autism symptoms checklist that can be completed by parents.) "Pre" and "post" comparisons look compelling; however, it appears that these data are collected through on-line submissions by parents and participating physicians, not through a scientifically acceptable method. No information is given with regard to sample size or the use of any standard scientific procedures to establish the validity of the data (e.g., treatment and/or placebo control groups, double-blind procedures).
To further promote their product, the marketers make use of Respen-A™ blog and "Respen-A™ in the News" links. A review of their posted "news" items reveals the following: 1) a mention on the Spectrum Magazine Facebook page; 2) an "advertorial" (i.e., an advertisement written in the form of an editorial) on the Spectrum Magazine website; 3) a single blog post by a parent trying the drug with her son; and 4) a "news release" apparently authored by one of the marketers announcing her presentation at a Autism One/Generation Rescue conference.
What is the state of the science with regard to the use of reserpine in treating autism? Our review of the scientific literature revealed one study published several decades ago in a peer-reviewed journal (Lehman, 1957). Using the administration of a simple rating scale, Lehman found positive effects on the behavior of 9 children described as having autism; however, it should be noted that this study did not employ important procedures for scientific control (e.g., double-blind ratings, control group). Also, it is worth noting that these authors report concerns about possible toxicity and side-effects (e.g., withdrawal symptoms) related to an improper dosage of reserpine. No other peer-reviewed studies have been identified in the last 54 years!
What can we do to evaluate the science behind hyped marketing schemes, such as the one promoting Respen-A™? First, recognize common signs of baloney, including reliance upon testimonials and contrived "news" to create the "feel" of documented treatment effectiveness. Second, recognize that just because a treatment is described as "homeopathic," it is not necessarily safe. In this instance, the active ingredient, reserpine, is a psychoactive drug that has serious potential side-effects, including dizziness, dry mouth, loss of appetite and several others. Third, ask providers- and marketers- direct questions about the state of the science behind their claims and politely request direct answers. Marketers should present their autism treatment products without contrived hype and ill-defined data. And, they should present the state of their science clearly and accurately. Persons with autism and their families deserve nothing less.
Lehman, E. , Haber, J., & Lesser, S. (1957). The use of reserpine in autistic children. The Journal of Nervous and Mental Disease, 125 (3), 351 – 356. The National Center for Biotechnology Information. http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000095/, (accessed February 25, 2011)