Beware of Hair Growth Formulas and Inappropriate Claims for Minoxidil Regrowth
According to the indictment below, a named doctor has been using the Internet to sell non-approved doses of Minoxidil with claims that are not proper. Read the document below for details
SALT LAKE CITY ‹ Four men, including two Utah’s, face federal charges for allegedly selling hair replacement drugs over the Internet without U.S. Food and Drug Administration approval. Dr. Richard Lee, 72, and James Dorius, 69, both of Whittier, Calif., owned Regrowth, LLC, a business that made and sold hair treatment drugs online. Alexander Ahn, 32, and Min Kim, 32, both of Provo, ran a Utah company called Minoxidil Solutions that sold the drugs after Regrowth had agreed with the FDA to pull them from the market, according to the indictment.
The indictment alleges that the FDA discovered that Regrowth was selling drugs Lee made using his own formulas and recipes dating back to 1996. Some of the products contained active pharmaceutical ingredients. The company was not registered with the FDA and did not seek or obtain approval to sell its hair growth drugs, according to the indictment. As apart of an agreement with the FDA in February 2011, Lee stopped selling the products and sent customers an ³urgent drug recall² notice informing them of potential health hazards. Two months later, Lee and Dorius delivered Regrowth¹s remaining drug
>ingredients and manufacturing equipment to Kim and Ahn in Utah. According to the indictment, Kim agreed to pay Lee and Dorius half of what Minoxidil Solutions earned on the sale of hair growth drugs made using Lee¹s ingredients and formulas. “These kinds of cases are important because in many instances individuals are advised by FDA that they cannot lawfully manufacture and sell unapproved and misbranded drugs, yet even after warning, they continue to manufacture and sell these prohibited drugs,” said Patrick J. Holland, special agent in charge of the FDA criminal investigations office in Kansas City. Lee, Dorius, Ahn and Kim are charged with conspiracy to introduce misbranded drugs into interstate commerce, which carries a penalty of five years in prison and a $250,000 fine. All four men are scheduled for an initial appearance in U.S. District Court on Oct. 23.
It is fascinating how, on other blogs, a minority (but vocal) number of readers were outraged at the 2011 FDA action demanding that Drs. Lee (a board certified radiologist) and Dorius cease manufacturing and production of numerous compounds, including 15% minoxidil ointment. These readers hailed the FDA’s action as “government intrusion” on their freedom to decide what is best for them. Yet, the government regulates speed limits, what can be used in food, air quality, and hundreds of other things. For drugs, a company must show that the drug is safe and effective and has the proper risk/benefit for approval. There is no data on almost all of the compounds that Drs. Lee and Dorius sold and thus ‘informed consent” for the consumer can not be fulfilled to allow proper decision-making. Moreover, most of the commenters upset with the action by the FDA and claiming that Dr Lee provided them with sheets about risks don’t understand the ‘nature of evidence”. The quantification of risks comes from clinical studies (usually placebo-controlled) and not from theoretical extrapolations from lower-dose substances. This is not “off-label” use of an approved agent for an unapproved condition (legal) but use of unapproved drugs. Numerous anecdotes from those who believe that they had benefit do make sense; the question is what happens when such a person gets a significant cardiac arrhythmia and what is the risk of such? No one knows; it hasn’t been studied.
The fact that this enterprise was supplying drug to the following countries also speaks to its scale: Argentina France Malta South Africa Australia Germany Mauritius South Korea Austria Greece Mexico Spain Azerbaijan Guam Netherlands Sweden Bahrain Hong Kong New Zealand Switzerland Belgium Hungary Northern Ireland Taiwan Bolivia Iceland Norway Thailand Brazil Indonesia Peru Trinidad Bulgaria Ireland Philippines Turkey Canada Israel Poland UAE China Italy Portugal Ukraine Colombia Japan Puerto Rico United Kingdom Croatia Jordan Qatar Uruguay Cyprus Kuwait Republic of Georgia Vietnam Czech Republic Latvia Romania Yugoslavia Denmark Lebanon Russia Ecuador Lithuania Scotland Estonia Macau Serbia Faroe Islands Malaysia Singapore Finland Maldives Slovenia
Previous discussions of this on this blog can be found at:
Can only speak for myself but Dr. Lee’s Xandrox product line was an awesome product that gave me the best results than any other topical before or since.
And that was the problem, he had thousands of customers buying off of him instead of buying the greasy crap Rogaine. I’m sure the makers of Rogaine had a hand in getting the FDA to shut him down.
Pfizer (the manufacturer of Rogaine) makes virtually nothing off these sales given that the drug (minoxidil) is now generic. In contrast, Pfizer makes billions of dollars of profit off their other drugs (for example, Pfizer’s Lyrica for neuropathic pain had over $600 million dollars in revenues last year alone). It is naïve to think that a multinational corporation with billions of $ of revenue cares about Dr Lee’s operation or even has such influence over the FDA. The FDA stopped this operation because it was illegally manufacturing compounds of which there was no safety information approved via an regulatory agency. No unapproved drug is 100% bad and no approved drug is 100% good. So, while Dr. Lee’s compounds possibly benefitted many, the risk/benefit profile related to both efficacy and safety to make an informed decision just wasn’t there. Many drugs – even for life-threatening conditions (e.g., sitaxsentan for pulmonary hypertension) – are removed from the market or not approved if a serious reaction is discovered in clinical trials or the post-marketing setting that changes its risk profile. Given the potential cardiotoxicity associated with oral minoxidil, the absence of adequate (non-anecdotal) safety info on 15% formulations makes the risk/benefit threshold very low for a cosmetic condition. If 15% minoxidil truly had a better profile than 5%, it would seem to be advantageous and profitable for a drug company to develop it (I assume Pfizer’s patent has expired given the generic availability of 5% formulation).
I don’t think the makers of Rogaine would need to be involved, if you sell an unlicensed medication the FDA will likely investigate and issue warnings/open proceedings against you. This doesn’t sound like a corporate bullying case, it sounds like someone was knowingly breaking the law and got caught.