February 09, 2001
Issue # 33

MR. ARNOLD GOES TO WASHINGTON
by Pat Arnold

As I am sure most of you know already, androstenedione (and hence other prohormones) has long been under threat of being removed from the market by the federal government.  This is not really due to the government itself having any particular vendetta against Andro, but rather due to relentless political pressure from special interest groups.  These groups are primarily the medical establishment and sports organizations.  The International Olympic Committee (IOC) has been particularly aggressive in its war on Andro lately, due to the fact that the winter Olympic games of 2002 are going to be in Salt Lake City, Utah.

Some of you may remember last summer when the drug czar Barry McCaffrey made a speech to some athletic organization where he blasted androstenedione and promised that it would be banned within a few months.  As a manufacturer of prohormones, my partners and I were naturally quite concerned.  We knew that we had to find out what was going on, and what, if anything, we could do to stop this impending ban.

Our first course of action was to contact the National Nutritional Foods Association (NNFA), which is the strong and aggressive lobbying group for the nutritional supplement industry (the NNFA is basically responsible for ephedra still being on the market).  They were very helpful and supportive of our cause, and they set us up with a legal firm in Washington that specializes in cases dealing with the FDA and DEA.  This firm is called Hyman, Phelps, and McNamara (HP&M), and it consists of former employees of the two agencies. 

The first thing that HP&M did was make calls to find out exactly what was going on with androstenedione.  What they specifically found out was that the FDA had passed the buck to the DEA to do something about andro.  Furthermore, the DEA was being pressured by Barry McCaffrey (head of ONDCP * ) who for one reason or another had a particular hard-on for Andro.  The task for the DEA was to determine that androstenedione was an anabolic steroid, and then to add it to list of the Anabolic Steroid Control Act of 1990, thereby classifying it as a controlled substance.

The DEA had supposedly allocated money for animal testing to demonstrate the anabolic activity of androstenedione.  According to what HP&M found out, the test was scheduled to be completed no earlier than September 2001.  This test, according to comments made by James Tolliver (the DEA chemist in charge), was to use castrated animals administered large dosages of Andro by injection.

Clearly this was an attempt by the DEA to circumvent the normal scheduling process (a complex procedure involving objective analysis of scientific evidence and public debate), and simply “pigeon hole” Andro into the control act using totally unrealistic and manipulated scientific evidence. 

We next set up a meeting with the DEA officials in charge of the Andro issue.  We had to present our side of the story.  We had to show that we were familiar with the data on androstenedione and (lack of) muscle growth, show that we had the support of a influential population of consumers (older people), and show that we were familiar with controlled substance scheduling and would legally object to any inappropriate moves against Andro.

The meeting was set for February 7^th.  In preparation for the meeting we sought out a team of industry representatives and technical experts on steroids and Andro.  We ended up recruiting a team consisting of myself, my brother John, steroid lawyer Rick Collins Esq., Tim Ziegenfuss PhD (prohormone researcher), Rick Cohen MD (owner of Medlean and anti-aging doctor), and Luke Bucci PhD (director of research for Weider Nutrition International).  Ryan Hornbuckle also attended as an observer on behalf of EAS, as did two attorneys for the NNFA and attorney Mary Kate Whalen from HP&M.

Together we organized a presentation for the DEA meeting.  I prepared to cover the existing animal data on androstenedione and muscle growth, Ziegenfuss was to discuss the human studies to date, Rick Cohen would handle the use of Andro in andropause, Luke Bucci would present some Weider research on Andro, and Rick Collins would handle legal aspects. 

A week before the meeting, we heard from the NNFA that the DEA had approached Senator Orrin Hatch’s staff to discuss supplements (particularly Andro).  Utah senator Hatch is the sponsor of the DSHE Act, which allows for the open marketing of nutritional supplements without the necessity of FDA approval.  HP&M set up a meeting with ourselves and Hatch’s staff to take place after the DEA meeting.  We were to address the andro issue and all aspects regarding it and the 2002 Salt Lake City Olympic games.

We all arrived in Washington the day before the meeting, got together in the hotel, and prepared by going over everyone’s presentation and discussing any issues which may arise.  We spent over eight hours preparing.  By the next day we were all on the same page and were very well organized.

On the morning of February 7, we met with the DEA people.  They included Frank Sapienza - the director of the Office of Diversion Control, his assistant, and chemist James Tolliver – in charge of testing.  We presented our material to the DEA, and with the exception of a few technical questions from Tolliver, the response was pretty quiet.  The demeanor of the DEA officials was quite agreeable however, and judging from the responses that they gave towards some questions we asked them at the end, they seemed to understand where we were coming from.  They admitted that one animal study would not be enough to counteract the enormous amount of research that we demonstrated existed refuting andro’s anabolic abuse potential, and that more studies would have to be performed to really prove that andro was anabolic.  It was clear that this was not something the DEA wanted to waste their time on (given limited funds and much more important issues to handle), and they indicated that they would be more than happy to work with us to resolve the issue.  They appeared to understand that scheduling Andro was not an appropriate way to approach this problem, and seemed to view us as a group that could perhaps work out a solution directly with the forces pressuring the DEA to schedule Andro.

We left that meeting feeling quite optimistic, and went over to visit Senator Hatch’s staff.  We sat down with a couple of Hatch assistants and went over the general history of Andro, and the situation as it currently stands with the government.  Hatch’s assistants informed us of the pressure that they were getting from IOC representatives (a bunch of arrogant princes and ambassadors) to do something about the terrible Andro and the unfair advantage it gives people and abuse by kids (and other silly crap).  The IOC is very angry at Hatch because of his role in making supplements like Andro and creatine (which they consider evil) freely available in this country.  Hatch of course realizes how ridiculous they are in demanding that the USA ban a supplement basically because of testing issues regarding a handful of Olympic athletes, especially considering that Andro is already on the IOC banned substance list.

We offered to speak directly with the IOC people in an attempt to take the heat off Hatch, and to perhaps bring some sense to them and work out some compromise.  One issue that has to be addressed with them is the supplement contamination issue, which is just coming to light as being a big problem in this industry.  That will be something I will cover in a later article for sure.

So basically this whole Washington trip was a success, and gave us reason for hope that Andro and other prohormones will be saved from government control.  However, this was just a start of what is going to have to be an ongoing lobbying effort on behalf of our lawyers and the members of the Prohormone Research Organization (PRO), which we now call ourselves.  Up until now, with the exception of a contribution from Pinnacle, LPJ has footed the entire bill for the legal assistance.  Unfortunately the costs are beyond what one or two companies can handle and we must get contributions from all the major prohormone sellers.  Weider has indicated that it might contribute, and EAS may as well.  Hopefully, the results of this meeting will inspire other companies to join in and finish what we started.  We all stand to profit together in the sports supplement industry if we work together as a team.  If we don’t, then we all lose.

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