More About Xandrox and the FDA
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. “Off-label†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:
“Good 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 – especially with high-dose topical minoxidil – 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 “evidence-based†medicine: “Here, buy this because I said it does A, B, and C – don’t worry about any evidence.†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 “FDA cracking down on drugs sold online.†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 “Therefore, patients no longer have access to the drugs that they have used for over twenty-five years.†First, these drugs in the formulations he has concocted – have not been available for over 25 years and that’s the point. I can’t just go online and – in the absence of regulatory approval based on data – begin selling “super-aspirin†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 – MD’s doing the same thing as he did and they haven’t been touched…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.
I wonder about the efficacy of using anti androgens and dht blockers. Do they work at all? Is there any study to support this? Also, 15% minoxidil is scary sounding. If it worked and was safe, I’m sure the Rogaine company would go beyond the 5% “maximum strength” they currently sell.
I do however wonder why it took 20+ years for the FDA to notice Dr. Lee! Seems like that is a track record for safety there.
Alright, Xandrox aside, anybody know where I can now buy the 15% solution of simple Minoxidil? Thanks.
The problem I have with this is that there are a lot of other websites either selling greater than 5% Minoxidil, and or topical Finesteride. Why are they not being shut down too? Actually the main reason I used Xandrox is because it had better inert ingredients. It irritated my scalp less, dried quicker, didn’t smell, and didn’t leave a sticky residue like Rogain does. And, I got better results. Dr. Lee will be missed.
This post, in my opinion, mixes safety and efficacy issues together; I think for clarity they need to be considered separately.
Are there risks from Xandrox, and if so, were these risks properly disclosed to patients? Are high-dose concentrations of minoxidil effective?
I was an original patient of Dr. Lee (about 15 years ago). He has always supplied detailed drug information and safety sheets with his products, which disclosed numerous risks inherent in the various ingredients. I have no way of knowing if he maintained an adverse reaction log or did any monitoring for side effects.
From Dr. Lee’s writings, it seems that higher doses of minoxidil are difficult to formulate in a way that remains stable and is absorbed. Higher doses are useless if they are not absorbed. Since the earliest days of minoxidil’s usage for hair loss, it has been known to have a dose-dependent response. I have no knowledge as to the reasons why Rogaine is not sold at higher than 5% (it could be safety or absorption or convenience or who knows). Are Dr, Lee’s higher strength formulations effective? This is difficult to know without seeing whatever studies he has done.
oh but it’s fine for my hair clinic or pharmacy to sell the stuff?
I think it was pure financial. They wanted $800m and for him to go through the FDA stage trials (5-10 years..) No wonder so many drugs that could make lived much eaiser never make it out.
any how where can I can finasteride as thos eprices he used to sell it at? Now that worked!
Ged
The FDA does not make the “$800 MM” figure you cite. That is the cost of developing a drug from discovery to approval for the drug company. Dr Lee was shut down because he had no safety or efficacy *data* to support his concoctions. This is a requirement beyond supply a sheet of ‘risks”.
I’ve used Dr. Lee’s products for over 15 years, and they were BY FAR the most effective, and I tried them ALL. It baffles me that “people” contend that he did not offer adequate/proper information regarding the safety/efficacy of the ingredients in his products. His website was plastered with this information, including MANY references to MEDICAL studies, warnings, suggested usage/doseage etc. Plus, every order included an information pack which disclosed this information and suggested places to obtain even MORE information.
When I first became interested in using his products, Dr. Lee required me to have a 15 minute phone consultation with him prior to “prescribing” me his products. In fact, it was clearly stated on his site minoxidil.com., that a consultation was REQUIRED prior to being able to order his products… In contrast, my GP talked to me for 20 seconds, then prescribed oral Finasteride, which caused my severe sexual dysfunction a few months later (at 30 yrs. old). So, FDA, kiss my ass!!!… FYI, as Dr. Lee points out, and his referenced studies conclude; TOPICAL Finasteride is very effective, and FAR less likely to cause any side effects.
I suspect the FDA may have had a little push ($$$) from Upjohn, considering Rogaine is nowhere as effective as Dr. Lee’s products… I, like many others, am watching that bald spot grow, waiting for some comparable products to appear… Which leads me to my last point:
The trademark on “Xandrox” expired a few years ago, and Dr. Lee has been completely shut down for a few months. The are some imposters riding his coat-tails.