Note: BaldingBlog often receives incredibly insightful emails from our readers. The following comments echo many of my thoughts on the subject of Xandrox and Dr. Lee. The writer wishes to remain anonymous, but he’s contributed posts in the past about the FDA and I want to thank him for taking the time to elucidate the issues so clearly.
This is a follow-up (for those that missed it), about the FDA stopping Xandrox sales.
- The post about Xandrox requires clarifications and additional information about physician prescribing and the FDA. It is correct that Dr Lee makes unsupported claims about his products (whether it is his unregulated herbs or regulated medicines sold online). However, a more likely reason why the FDA intervened to remove sales of Xandrox (containing 15% minoxidil and finasteride) is that a potential for increased risk (i.e., a safety concern) existed. Even with substances that do not normally fall under FDA jurisdiction (e.g., herbs that do not require regulatory approval for sale), the FDA can intervene if a health concern exists. A good example is when concerns regarding the safety of ephedra supplements (and potential cardiac deaths) led the FDA to ban the sale of ephedra-containing supplements in the United States in 2004.
The poster asks whether prescribing Xandrox in this manner is acceptable because it is off-label. â€œOff-labelâ€ use presumes use based on a specific scientific rationale and sound medical evidence (data on effectiveness and safety of Xandrox is absent). While most off-label use is the same dose and formulation for a different indication (thus allowing for an understanding of the likely safety profile), the FDA legally allows and classifies off-label use as below, which can include different doses:
â€œGood medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects.â€
With Xandrox, there is zero data available on the safety and efficacy of the formulation and one wonders â€“ especially with high-dose topical minoxidil â€“ what cardiac issues could result. But, who knows. Data (and thus informed decision-making) for the user is not available. This is the antithesis of â€œevidence-basedâ€ medicine: â€œHere, buy this because I said it does A, B, and C â€“ don’t worry about any evidence.â€ Or better yet, “I’m getting great results…I haven’t had a problem (yet)”.
- As a result, those who the poster refers to as benefiting may be the same individuals who may be getting good results and have no side effects, but may be at increased risk to have a complication (again, who knows, the proper studies have not been conducted). In other words, besides the unsupported claims, the idea of selling drugs in different concentrations than have been studied is not very good informed consent. Medicine also has a long history of drugs that are dangerous but do not produce their problems in most who take them (several effective diet drugs initially considered safe were removed from the market worldwide because of serious heart conditions that were so infrequent to only be discovered after millions of individuals took the drug after regulatory approval).
And, no, drug companies don’t have the power to affect regulators such as the FDA (it is usually the other way around). But of course the pharmaceutical companies billions of dollars are not going to be affected by Dr Lee’s online sales. This has nothing to do, as the reader suggests, with the â€œFDA cracking down on drugs sold online.â€ This is the FDA cracking down on unapproved drugs sold online within their jurisdiction.
Finally a serious editorial comment. Dr Lee’s site notes that â€œTherefore, patients no longer have access to the drugs that they have used for over twenty-five years.â€ First, these drugs in the formulations he has concocted â€“ have not been available for over 25 years and that’s the point. I can’t just go online and â€“ in the absence of regulatory approval based on data – begin selling â€œsuper-aspirinâ€ at 40 times the approved dose and be upset when I am asked to stop (fortunately before an expected lawsuit from the many who will probably end up with peptic ulcers from this approach).
The poster concludes that “knock on wood â€“ MD’s doing the same thing as he did and they haven’t been touchedâ€¦yet” as if such advertising of claims that are unsupported is somehow a virtue. No one benefits when physicians (and most often non-physicians) sell drugs online that may benefit some but present undefined (unstudied) risks.