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Collins McDonald Gann Law Firm Gives Presentation at International Society for Sport Nutrition Conference

Top supplement industry attorneys are predicting increased regulation for the supplement industry within the next 4-8 years Rick Collins and Alan Feldstein, representing the law firm Collins, McDonald and Gann, identified four potential “minefields” facing supplement companies in a presentation entitled “Supplements, Science, and the Politics of New Washington” given at the International Society of Sports Nutrition Conference (ISSN) in New Orleans on June 15, 2009.

The tone of the presentation was “cautionary but not pessimistic” as Collins and Feldstein identified the risks facing the supplement industry in general but especially the sports nutrition segment. These risks include the (1) pro-regulatory philosophy of FDA and FTC; (2) state attorney generals actions on behalf of citizens; (3) class action lawsuits; and (4) profit-motivated adulteration.

The FDA and FTC will become increasing pro-regulation thanks to new appointments according to Collins and Feldstein. Key nominations by the Obama administration include Dr. Margaret Hamburg and Dr. Joshua Sharfstein who have been confirmed as the new FDA commissioner and FDA principal deputy commissioner, respectively. Of particular interest to the supplement industry is Dr. Sharfstein’s role as a former advisor to the anti-supplement Congressman Henry Waxman. Furthermore, David Vladeck, the new FTC Director of the Bureau of Consumer Protection, has long been critical of supplement industry and misleading claims during his 30 years working with the Public Citizen Litigation Group.

Secondly, state attorney generals are increasingly likely to sue supplement companies under consumer protection statutes. Local district attorneys (particularly in California) are participating too.

Also, there has been a growing trend towards plaintiffs filing class action lawsuits targeting “false marketing claims” and “false advertising claims” made by supplement companies. The law firm Call, Jensen & Ferrell is representing plaintiffs in a multi-million dollar class action lawsuit against Musclemeds for violating California Consumer Legal Remedies Act. A California court has appointed the firms of Robinson, Calcagnie & Robinson and Call, Jensen & Ferrell to represent plaintiffs in a $100 million class action lawsuit against BSN. The law offices of Juroviesky and Ricci and the law offices of Wood and Wood have each filed a class action lawsuits against Iovate Health Sciences and MuscleTech on behalf of plaintiffs in Ontario (Canada) and Tennessee, respectively.

Lastly, the FDA is going after supplement companies whose names/brands appear on the product for “profit motivated adulteration” even if the raw material supplier(s) or the manufacturer was responsible for the adulteration.

The reports of supplement tainted with Viagra, weight loss supplements spiked with pharmaceutical weight loss drugs, aromatase inhibitor products contaminated with androstenedione, and seizures and forfeitures involving unapproved new dietary ingredients (NDIs) increase the likelihood that the supplement industry will be more aggressively regulated.

Collins and Feldstein told researchers and scientists at the ISSN conference that the increased regulatory environment was an excellent opportunity for them to step up to the plate with clinical studies that would withstand scientific scrutiny. The demand for good researchers and good science in the supplement industry has become greater than ever.

But if prescription and/or illegal drugs to appear in supplements (even in trace amounts with no physiologic effects) or products appear that do not meet the definition of a dietary supplement or NDI e.g. methylated prohormone, then the FDA will step in aggressively with more stringent regulations and restrictions.

Source

“2009 International Society of Sports Nutrition Conference,” June 14-16, 2009

By Millard Baker

http://www.millardbaker.com

www.steroidsrx.com

Dr. Ramon Scruggs Admitted Prescribing Drugs for Performance Enhancement

Ramon Scruggs, M.D. pleaded guilty to one count of conspiracy to distribute anabolic steroids and import human growth hormone into the United States from China and one count of money laundering on June 1, 2009. Scruggs admitted to prescribing anabolic steroids and HGH “outside the usual course of professional practice” at his anti-aging clinic called New Hope Health Center in California. Scruggs acknowledged he prescribed the medications to athletes and bodybuilders for performance enhancing purposes and not legitimate therapeutic purposes.

Ramon Scruggs, M.D. openly worked with bodybuilders visiting his New Hope Med website as early as 1999; he felt that the best way for a physician to effectively supervise the health of a steroid-using bodybuilder was to medically monitor their steroid use and assure that bodybuilders avoided potentially dangerous black market sources of anabolic steroids. At the time, Dr. Scruggs felt that he was doing the right thing by monitoring and prescribing steroids to bodybuilders even if it was in violation of the law.

“I feel very comfortable in the choices I’ve made and the reason for those choices. I know that I’m helping people far more than I’m hurting them,” Scruggs said in an interview with Jason Mueller of Anabolic Extreme. “If you want to know the truth, I don’t like taking 22 or 23 year-old and putting them on steroids, it makes me nervous. Yet, I’d rather have them come to me and manage their steroid use, and then have them do it on their own.”

Dr. Scruggs liberally prescribed steroids to bodybuilders and athletes whose testosterone levels were considered normal. He justification his prescription policy by criticizing the established normal range accepted by the medical community.

“I’ll admit to you that as I do this, my criteria have relaxed. Before I would only do this with athletes or with ordinary citizens if they had a limitation, if they were hypogonadal, if they were on the low side of normal on their blood work,” explained Scruggs. “I’ve gradually relaxed that to include people who would be quote unquote normal. You’ve got to realize that virtually everything hormonal is considered normal by the establishment. They have virtually no ability to look at, let’s say the estrogen/progesterone levels for a woman, and testosterone for men and women, and say anything much about them at all because everybody from age 12 to age 90 is considered normal.”

Ramon Scruggs had already faced the consequences of his decision to liberally prescribe steroids to bodybuilders. In June 2004, the State of California formally accused Dr. Scruggs of prescribing steroids and ancillary medications without justification over the internet to patients who he did not physically examine. He settled his case with the State of California in August 2006. In the settlement, Scruggs agreed the state could prove the charges and accepted a $4,800 fine and 35 months of probation: during that time he is required to have an outside monitor, take various courses and cease prescribing over the Internet. The settlement was agreed to in August 2006 and took effect in March 2007.

Dr. Scruggs probably thought that his legal troubles were behind him. But in the fall of 2007, the Albany County District Attorney’s Office, which led the investigation of the steroid scandal involving Signature Pharmacy, leaked information that Dr. Scruggs prescribed steroids to professional baseball players Troy Glaus and Scott Schoeneweis playing for the Anaheim Angels in 2003 and 2004. As a result of the leak, federal prosecutors decided to re-open the case of anti-aging doctor Ramon Scruggs in an effort to find more baseball players who have used anabolic steroids.

Glaus and Schoeneweis as well as catcher Todd Greene and pitcher Ismael Valdez were interviewed by federal agents investigating Scruggs. Glaus and Greene testified at the grand jury that indicted Dr. Scruggs. The New York Times reported that Glaus and Greene told the grand jury that Mike Nicotera and Gene Casaleggio, senior partners for the Sparta Group, referred them Dr. Scruggs.

Ramon Scruggs is scheduled for sentencing on September 14, 2009 by U.S. District Judge James Ware. He faces up to 25 years imprisonment and a $750,000 fine.

Ramon Scruggs, M.D. has and continues to pay a substantial penalty for prescribing steroids and HGH to bodybuilders and athletes, including a Chapter 7 bankruptcy filing in October 2005.

“I don’t have any emotional reserve left,” Dr. Scruggs told Michael Schmidt of the New York Times. “I have been fighting this for 10 years. It has destroyed myself, my life and my family. If I was smart I would be on a beach in Manawatu.”

Sources

“Doctor with ties to ex-Angels pleads guilty in steroids case,” June 3, 2009

“Southern California Doctor Pleads Guilty to Steroid Distribution, HGH Importation, and Money Laundering,” June 2, 2009

“Inside a Tempting World of Easy Steroids,” April 11, 2009

“Questions and Answers With Ramon Scruggs,” April 11, 2009

”Inquiry Into Doctor May Link Players to Drugs,” March 12, 2008

“Interview with Dr. Ramon Scruggs,” April 1999

By Millard Baker

http://www.millardbaker.com

www.SteroidsRx.com

Officials Have Been Slow to Release Details About Actual Scope
of Steroid Distribution

The major Fort Bend County drug investigation codenamed Operation “Farmacia de Juicy Phruit” was characterized as primarily an anabolic steroid bust that revolved around personal trainers who sold steroids to their clients and bodybuilders. Law enforcement officials from various local and federal agencies repeatedly emphasized the central importance of anabolic steroids during the May 27, 2009 press conference announcing the arrest of 73 defendants who were presumably bodybuilders and personal trainers; 51 defendants indicted by a Fort Bend County grand jury and 22 defendants indicted by a federal grand jury.

“The majority of this thing is built around body trainers at fitness centers,” said Fort Bend County Sheriff Milton Wright. “Their livelihood is getting customers they can develop physically - legally or illegally. It doesn’t matter in their eyes, as long as they get the job done.”

The significance of the recreational “party” drugs such as Oxycontin and Xanax uncovered during the investigation was minimized. They were described as drugs incidental to steroid use by bodybuilders. “There’s been other offshoots from it because sometimes the steroids cause severe muscle pain and that leads to painkillers,” according to Sheriff Wright.

The steroid bust allegedly involved “hundreds of thousands of dosage units of anabolic steroids, human growth hormones, MDMA (ecstasy) and controlled pharmaceutical substances”; however, officials refused to offer a breakdown of the relative quantity of each class of drug involved in the investigation. The amount of steroids involved versus amounts of other drugs were not reported.

Acting U.S. Attorney Tim Johnson reported that the investigation originated with Charles “Brock” Falkenhagen in late 2006. Johnson also stated that Falkenhagen was named on each of the 22 federal indictments. The unsealed version of the 46-count Falkenhagen indictment had the 22 names of his co-defendants redacted.

The Falkenhagen indictment provides some insight into the nature of the charges facing the defendants in the Fort Bend County bust. A review of the indictment revealed that ONLY ONE count out of the 46-counts involved anabolic steroids.

There were 4 counts involving Oxycontin, 4 counts involving MDMA (escstasy), 9 counts involving smuggling human growth hormone (HGH); 28 counts involving money laundering related to HGH. The money trail also suggests that HGH may have accounted for most of the proceeds. The single steroid-related charge involved the “conspiracy to manufacture/possess with the intent to distribute (anabolic steroids)”.

The Falkenhagen indictment suggests that the importance of anabolic steroids in this bust may have been considerably overstated, at least in the federal cases. The quantity of steroids involved may well have been less than the press was led to believe during the announcement of the operation.

Officials acknowledged that no professional athletes were involved or implicated in the so-called steroid bust. The defendants in the case were not accused of selling steroids (or any other drug) to any minors.

In the absence of steroids sales to pro athletes or high school students, officials instead trumpeted the imaginary risks of steroids.

DEA Special Agent Zoran Yankovich warned journalists about the unreported dangers of anabolic steroids. Yankovich imagined that steroids lead to “broken families, broken homes and people who are hurt [by steroids] that we never know about.”

Fort Bend County Sheriff Lt. Glen Dening asserted that, even in the absence of any evidence of steroid sales involving high school students during the current investigation, the steroid dealers arrested would have probably sold steroids to minors - eventually.

“They (suspects) work out at all the local gyms in Fort Bend County, so, of course, the high school students have access to those gyms. So, inevitably, it’s going to happen. They’d end up customers of these steroid dealers,” Lt. Dening predicted.

At least one journalist was baffled during the press conference as to why most of the defendants who were arrested were relatively “skinny” and did not appear to lift weights much less use steroids. FDA Agent Tommy Hennesy suggested that underdosed or bogus steroid products from underground lab as an explanation. This of course begs the question: How many of the defendants were in fact personal trainers and/or recreational bodybuilders? Were most of the defendants really involved in bodybuilding and fitness?

It remains to be seen how big a factor steroids were in the so-called major steroid bust in Texas. The nature of the arrest warrants handed down by the Fort Bend County District Attorney may be completely different than the indictments issued by the U.S. Attorney’s Office in the Southern District of Texas.

Sources

“Fort Bend holds suspects in alleged steroid ring,” May 29, 2009

“Bodybuilders, Personal Trainers and Gym Owner Arrested in Texas Steroid Bust,” May 27, 2009

By Millard Baker

http://www.millardbaker.com

www.SteroidsRx.com

Richard Thomas Uses Arrest As An Opportunity to Capture National Spotlight

Richard “Andy” Thomas was extremely cooperative and friendly with undercover narcotics detectives as he was arrested along with his wife on various charges related to the distribution of anabolic steroids. Agents with the Polk County Sheriff’s Office (PCSO) and Immigrations and Customs Enforcement (ICE) raided the Lakeland Florida home of Richard and Sandra Thomas and recovered approximately $200,000 worth of anabolic steroids and ancillary drugs. Afterwards, Thomas bragged about the scope of his steroid distribution stating that he was currently the largest steroid dealer in Central Florida and, at one time during the past decade, the entire State of Florida. Such boastful and incriminating statements are highly unusual among steroid dealers when they are arrested. Most dealers are not as forthcoming with information about their illegal activities.

Richard Thomas, perhaps seeing his arrest as an opportunity to capture the national spotlight, continued talking to detectives about his illegal steroid business, specifically about customers who played professional baseball, hockey and football. The naming of pro athletes using steroids is a surefire method of gaining the full attention of law enforcement, prosecutors and sportswriters. Consequently, Thomas’s claim that he sold steroids to members of the Washington Capitals hockey team and Washington Nationals baseball team had its desired effect.

"He claimed to have sold drugs to professional sports people," Polk County Sheriff Grady Judd told A.J. Perez of USA Today during a phone interview. "He said, 'You pick the sport and I sold it to them.' We pressed him further and he said he sold steroids to the Washington Capitals and the Nationals."

Thomas started using anabolic steroids to become a celebrity like his hero Arnold Schwarzenegger. This plan may not have materialized as anticipated but Thomas seems willing to use the media and criminal justice system to gain a certain measure of fame (or infamy) as a dealer for pro athletes. The self-aggrandizing Polk County Sheriff Judd seemed happy to oblige by holding a national press conference to share the admittedly unsubstantiated allegations.

Thomas stopped talking to detectives shortly after a public defender was appointed to represent him. However, the silence was short-lived. Thomas agreed to a jailhouse interview with the New York Daily News during which he promised to share details of a “huge story” once he was released from jail. Thomas is being held in Polk County Jail on a $425,000 bond.

There is widespread skepticism from all sides regarding the veracity of Thomas’ claims. The Washington Capitals and Washington Nationals have predictably denied the allegation citing their perfect record of steroid testing.

“We have no reason to believe there is any merit to this story, but the National Hockey League and the Washington Capitals take all such allegations seriously,” responded the Capitals in an official statement. “Capitals players have fully participated in the NHL’s random drug testing program, and at no point has a Capitals player tested positive.”

“I don't have any particular concerns, because as you've seen in recent times, baseball has the most stringent testing for performance-enhancing drugs,” Nationals team president Stan Kasten said in response to the allegations. “Players run afoul of rules, they're caught, and they're disciplined."

Sheriff Judd admits that the Polk County Sheriff’s Office has no information to corroborate the claims made by Thomas. Thomas’ computer and hard drive were seized by investigators during the raid but their contents have not been analyzed. It is likely that the names of several customers could be uncovered during forensic analysis of the hard drive. It is unknown whether the names of professional athletes will be discovered. Nonetheless, Judd wants to believe Thomas.

“At this point in time, we have no corroboration about what he said about professional athletes, but he has two things that give him credibility,” Judd rationalized. “Number one, he had every imaginable steroid you can get in his house. Number two, why pick two teams that are obscure in our area? Why not say the Orlando Magic, Tampa Bay Rays or the Florida Panthers, or the New York Yankees or the Detroit Tigers, who have spring training facilities in our area?”

Richard Thomas and Sandra Thomas have both been charged with ten counts of “possession of anabolic steroids with intent to sell or distribute”; ten counts of “importation of anabolic steroids into the State of Florida”; one count of “maintaining a dwelling for drug sales”; and one count of “possession of a firearm in commission of a felony.” Sandra Thomas has been released after posting a $215,000 bond; Richard Thomas remains in Polk County.

Sources

“MLB, NHL investigating steroids claims,” May 28, 2009

“Steroid suspect Richard Thomas juiced to 'be like' Arnold Schwarzenegger,” May 28, 2009

“Kasten: 'I Don't Have Any Particular Concerns',” May 27, 2009

“D.C. teams looking into statements made in Polk steroids case,” May 27, 2009

By Millard Baker

http://www.millardbaker.com

www.SteroidsRx.com

Abstinence Approach Preferred Over Honest Approach for Sex and Steroids

Former Boston Red Sox player Lou Merloni recently described a meeting during Red Sox spring training when a physician advised baseball players how to properly use anabolic steroids while minimizing the side effects. The doctor made a distinction between steroid use and abuse with a harm reduction approach to steroid education. Merloni emphasized that the physician was not advocating or endorsing steroid use but simply explaining how to minimize harm from the performance-enhancing drugs. The former Red Sox infielder compared the steroid education lecture to high school sex education.

"It was like teaching your teenage daughter about sex education," Lou Merloni told the Boston Globe. "The organization acknowledged that there were likely players using steroids, and basically, 'If you're going to use them, this is how you use them so you don't abuse them.'"

The alleged meeting occurred when Lou Merloni was still an active player with the Red Sox. Merloni and his teammates were expecting the usual lecture demonizing anabolic steroids where the doctor would overstate and exaggerate the adverse side effects of steroids.

“I'm sitting in the meeting. There's a doctor up there and he's talking about steroids, and everyone was like, 'Here we go, we're going to sit here and get the whole thing: They're bad for you,'” according to Merloni. But the MLB players were shocked when the doctor proceeded with an open and honest discussion of steroids emphasizing harm reduction.

"If you're going to take steroids, one cycle won't hurt you; abusing steroids it will.' He sat there for one hour and told us how to properly use steroids while I'm with the Boston Red Sox, sitting there with the rest of the organization, and after this I said, 'What the heck was that?' And everybody on the team was like, 'What was that?' And the response we got was, 'Well, we know guys are taking it, so we want to make sure they're taking it the right way.'"

Merloni believed that the doctor was hired by the Red Sox organization and not the MLB Players’ Association (MLBPA). Former Red Sox general manager Dan Duquette strongly denied the allegation.

“It’s ridiculous. It’s totally unfounded,” said Duquette. “Who was the doctor? Tell me who the doctor is? If there was such a doctor he wasn’t in the employ of the Red Sox. We brought in doctors to educate the players on the major league drug policy at the time at the recommendation of major league baseball. This is so ridiculous I hate to even respond to it.”

Former MLB pitcher John Rocker claimed the MLBPA once hired a doctor who told him, Alex Rodriguez, Ivan Rodriguez, and Rafael Palmeiro how to safely use steroids. "If you do it responsibly, it's not going to hurt you," the doctor allegedly told them.

Such discussion of “responsible” steroid use completely contradicts the message promoted by the media. The steroid hysteria has made it impossible for most people to acknowledge that steroids can ever be used safely or with minimal side effects. Even among those that agree that steroid dangers are overstated, anything other than a steroid abstinence approach only proves that the MLBPA and/or MLB owners and organizations encouraged or were complicit in the rise of baseball’s steroid era.

Nonetheless, Lou Merloni’s analogy between steroid education and sex education is an interesting one. Hopefully, it stimulates discussion about the best way to approach baseball’s “steroid problem”. A harm reduction approach remains extremely controversial with little popular support. Most people would prefer that professional athletes “abstain” from anabolic steroids much like they would prefer that teenagers “abstain” from sexual intercourse. The abstinence approach tends to be morally-based often accompanied with scare tactics to discourage involvement. This approach is clearly a “feel good” approach but preaching abstinence and using scare tactics have not been particularly effective methods from decreasing either teenager sexual activity or performance enhancing drug use amongst professional athletes. Perhaps a scientifically-based harm reduction approach is the most realistic and pragmatic approach to such problems especially if the health of the individuals affected is the overriding concern.

References

“Merloni tells of PED advice from doctor,” May 11, 2009

“Let's end the silent treatment,” May 11, 2009

“John Rocker: Union doctor told A-Rod, me how to use steroids,” February 12, 2008

By Millard Baker

http://www.millardbaker.com

www.SteroidsRx.com