To understand why Sen. John McCain introduced a bill on dietary supplements, read the press releases. The legislation announced Feb. 3  addresses public safety, but mostly it’s about the reputation and revenue of professional and Olympic sports.

The evidence: McCain says in the release that “a little over a year ago the NFL suspended six players, including two players from one of the teams competing this Sunday, for violating the league’s anti-doping policy.  Several of the players were surprised that they tested positive for a banned substance because they used a dietary supplement they believed to be safe and legal.”

McCain ends the release, “It is my hope that this legislation will ensure that all Americans, including athletes, have all the information necessary to make informed decision when choosing whether to use a dietary supplement, and that the FDA has the ability to remove any harmful dietary supplements from the market.”

What organization was first to endorse the legislation? Major League Baseball. Commissioner Bud Selig issued a statement supporting the bill and MLB.com reported on McCain’s announcement of the legislation.

Next on board: The U.S. Anti-Doping Agency, which issued a press release with an affiliated group, Supplement Safety Now. Its members include Major League Baseball, NFL, NBA, NHL, PGA, NCAA and other national sports organizations. All are powerful organizations inside and outside Washington. And they share a complaint: Their athletes have been unwitting victims of mislabeled supplements that caused disqualifications and suspensions.

In other words, the products were bad for business. The groups want to arm the FDA with the data to monitor supplements and the power to yank immediately the detrimental ones off the shelf. They found an ally in McCain, whose 2008 presidential campaign received substantial financial support from athletes and others in pro sports, ESPN reports.

The initial response from groups representing supplement makers and marketers was tepid. “Though we have not yet examined this bill completely, it places new burdens on dietary supplements that are not required for any other class of food,” Michael McGuffin, president of the American Herbal Products Association said the third paragraph of a press release.

The last sentence of the third paragraph of a press release from the Council for Responsible Nutrition quotes CEO Steve Mister as saying, “The best way to help consumers is through collaborative efforts with industry, government and other stakeholders, such as USADA, to implement the current laws, to provide more resources and funding to FDA, and to pass the food safety bill, which already includes many of these provisions.”

As the bill moves from the headlines to the sidelines, look for an intense lobbying effort by sports organizations. Supplement-related scandals have hurt their reputations and wallets. They see a solution in increased federal action and will push hard for that.

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As we have written before, makers of nutritional supplements should pay close attention to comments submitted to the FDA before February 2010. There will likely be advocates for warnings on all products that make a claim to support good health. The agency’s rules on search-based advertising for health products could encompass non-prescription items such as vitamins and muscle-building powders.

The ruckus in Washington on Nov. 12 and 13 stemmed from FDA warnings in March to drug makers that their search-based ads did not contain proper product warnings. Drug makers backed off their advertising, and the search-engine companies saw revenues plunge. Everyone hurried to Washington to ask the FDA for clarification.

Google presented a solution. It told the agency that sponsored links are now less transparent and relevant. Google then proposed a standard for product-claim sponsored links:

1. A headline that links to a product landing or home page.
2. A first line with the Web address for that page, followed by an information message.
3. A second line containing a safety warning that cannot be altered, followed by a link to a Web page with more details on the warning.

You can see sample Web pages by Google at Scribd. Other companies and public advocacy groups will likely have ideas on how to balance sales messages and product warnings. There may be software solutions such as pop-ups or Flash that could be integrated in order to present more information in an ad, but an elegant solution seems unlikely. Thus, the FDA could write rules that force makers and marketers of nutritional supplements to alter their sponsored links in ways they never wanted.

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In the trade, it is called public service journalism, but this may qualify more as a disservice.  In the Sept. 21 issue with Tim Tebow on the cover (again?), ESPN Magazine devotes two well-illustrated and detailed pages on performance-enhancing drugs. This is a must read for every attorney who represents an athlete who tests positive. The article probably should not be allowed in the libraries of middle and high schools.

Curious about how to get in shape before pro hockey or baseball season starts? Use Tri-Test, says ESPN. Want to come off a steroid cycle? Do like Manny Ramirez and take HCG. The article explains how each drug works, its legal status with the World Anti-Doping Agency, and why athletes risk taking the product.

The article gives popular other names for a drug; our favorite is Apache, Dance Fever and Goodfella, all of which refer to Fentanyl, a synthetic opiate that ESPN writes has achieved popularity among some weightlifters.

ESPN warns, “Don’t try these at home,” to which we would add, ” or in a clubhouse, at a track meet or in a weight room.”

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We are not sure of the reason, but it seems that every three months or so, a national media outlet weighs in on an old story: tainted nutritional supplements. To be sure, the story will not go away in the sports world. Athletes who test positive for steroids often say they thought they were taking vitamins.

The dietary dangers faced by professional players is a good launching point for a substantive news story. If the pros can be victims, what about the amateurs playing high school and college sports? What are the players’ coaches doing about the dangers of contaminated supplements? Are industry forces and organized sports working together to eliminate the problem? If not, why not?

No, we get a rehash of anecdotes with the same question: Are vitamins safe? So goes the Sept. 7 article in the Wall Street Journal headlined, “What’s Really in Supplements?” with the ominous sub-headline, “Regulators and Physicians Raise Alarms About Dangerous Ingredients in Many Herbal Remedies.” The illustration is scarier; it features demons escaping an opened capsule.

Among the article’s weaknesses:

• No one at the FDA raises an alarm. One FDA official says consumers should read labels and another says that the agency is doing the best it can to find and ban bad products.
• Just a few — not the headlined many — herbal remedies are cited as causing problems. The article reaches back five years to a now-banned substance as an example. Why bring up ephedra if product integrity is an issue today?
• No event gives the article urgency. No one famous has become ill or died from taking a supplement. The most notable recalled product of recent times is Hydroxycut, which gets no mention. The article says that the  FDA will hold hearings this month without giving specifics.
• The reader service is laudable, but not prominent enough. The first mention of information sources about supplements appears in the fifth paragraph, after the anecdotal lead about a policeman who unwittingly took steroids.
• Statistical evidence of the prevalence of product contamination devolves into a he-said, she-said between HFL Sports Science and the Council for Responsible Nutrition.

After all of that, the Journal article treads on much of the same ground covered in a May 18 Sports Illustrated article that also fed on fear with the headline, “What you don’t know might kill you.” Where is the news?

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Placebos don’t work when you are asleep. Or if you have Alzheimer’s disease. But they do seem to make a difference in research and clinical practice, as I found when preparing a recent article for Nutraceuticals World.

In clinical trials for subjectively reported symptoms such as pain or mental state, the placebo effect is roughly 30%. But the average varies from condition to condition. For chronic fatigue syndrome or Crohn’s disease. the average reported improvement across multiple clinical trials was 20%; for osteoarthritis it was 40%.

And for any of the nearly dozen conditions tabulated for the article, the range from trial to trial was large. In 20 studies of bipolar mania, the average was a 31% improvement in the placebo groups, but the range was from 9% to 59%.

The placebo effect is impacted by variables in the design and conduct of clinical trials. For example, a larger placebo effect was reported when subjects had higher expectations of being successfully treated, or if the trial itself was larger, longer, or had more visits per trial. Use of the opiate antagonist naloxone reverses placebo-induced pain relief, suggesting production of endogenous opioids as a mechanism

At the medical practice level, the worst-case scenario is a charismatic doctor who invents or champions a novel treatment (or surgical procedure) – and then writes a book. The certainty of the healer-researcher raises expectations in the patients, leading to positive results. Sports performance products are also subject to a strong placebo effect.

The lesson? Testimonials and open-label trial results should never be provided as sole evidence of efficacy when a product marketing campaign is challenged by a regulatory authority.

Mark

David A. Mark, Ph.D., is president of dmark consulting LLC, a science consulting company serving the dietary supplement and functional food industry. Contact him at david@dmarknutrition.com or 978-897-0890.

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David Ortiz

The confusion surrounding steroid use in professional baseball has taken another strange turn. The Associated Press and New York Times report that eight of the 104 players who tested positive for steroids in 2003 fall into another category. The AP says that the eight did not test positive; the Times says that the eight took 19-norandrostenedione, which was legally sold over the counter at the time. It is now illegal and a player caught with it in his system will be suspended for 50 games.

David Ortiz has said from the time his name was publicly tied to the list that he had been taking vitamins. At a press conference on Aug. 8 before his Boston Red Sox played host New York Yankees, Ortiz said that he had bought supplements in the Dominican Republic and the United States. “I’m not here to make any excuse or anything,” according to a Times article. “I really used a lot of supplements and vitamins.” He added that companies would send him supplements, “but I never used or buy any steroids.”

Former Red Sox teammate Manny Ramirez, Yankee Alex Rodriguez and former Chicago Cub Sammy Sosa were also on the 2003 list. But for what? The details are in the hands of federal investigators, the players’ union cannot tell its members, and a federal judge has told everyone to keep their mouths shut.

Any language confusion in identifying nutritional products may seem unimportant to the public, but to folks in this industry there is a huge difference between a vitamin and a steroid. Or a supplement and a steroid.

When companies do not make the distinction to the satisfaction of the FDA, they hear about it. In October 2004, the agency wrote a warning letter to All American Pharmaceuticals and Natural Food Corporation regarding the labeling of the prohormone as a dietary ingredient. “FDA is not aware of any information demonstrating that androstenedione, 19-norandrostenedione, and 5-androstene-3b 17b-diol were lawfully marketed as dietary ingredients in the United States before October 15, 1994,” the letter said in part.

Apparently, 19-norandrostenedione is pretty strong stuff: “One of the most frequently misused steroid precursors (prohormones) is 19-norandrostenedione (4-estrene-3,17-dione, NOR), which is, after oral administration, readily metabolised to nortestosterone, also known as nandrolone (durabolin),” begins the abstract to a study published in 2008 on the prohormone. Its effect on the careers of All-Star players and Major League Baseball is being felt today.

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The statement also reads: “Products like these are frequently marketed as alternatives to anabolic steroids for increasing muscle mass and strength and are sold both online and in retail stores.  They are often promoted to athletes to improve sports performance and to aid in recovery from training and sporting events.  Although products containing synthetic steroids are frequently marketed as dietary supplements, they are NOT dietary supplements, but instead are unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness.”

The Council for Responsible Nutrition sent out an alert immediately following the FDA announcement, with phone numbers (866-359-3719 U.S. and 203-369-0144 international) for anyone to call and listen to a recording of the conference.

The seriousness of the FDA warning, coupled with heighten media exposure of the dangers that high school athletes face from taking steroids, may lead to action by regulators, sports associations and others. The heightened public awareness will likely lead to more consumer questions.

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The pros have rules. The NCAA has its rules. And now there is a media awakening that steroid use in high schools deserves attention.  Newspapers have focused on the subject in recent articles. The New York Times reported on a federal investigation into Tren Xtreme and Mass Xtreme. The Tallahassee Democrat wrote about the dangers of high school students taking supplements that build body mass.

Most of the experts in the articles work at universities, not in the nutritional supplement industry. There is no discussion of the benefits of supplements, just the dangers, such as this quote by a university director of sports medicine:

“If you’re buying something off the Internet and it costs $60 for 60 pills, it’s probably something illegal.”

Fair comment? Maybe. Balanced article? Probably not, because the industry is not being heard. That may be because no one wants to be in a news article about a company whose offices are being searched by investigator Jeff Novitsky of BALCO fame. Still, there is a need to get involved, to interact with reporters and editors who are covering sports, not diet and nutrition. Sports has become a home for news about money (contracts),  crime (arrests) and health (steroids and other drugs).

A part of the supplement industry has always engaged athletes, but with public attention shifting to the health of teenagers — steroid use, obesity, etc. — the supplement industry has not been heard often enough. Who will speak up?

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Calvin Pace

Calvin Pace of the New York Jets will be sitting out the first four games of the 2009 season because he violated the National Football League’s policy on doping. Unlike other athletes such as New York Yankees pitcher Sergio Mitre (who just completed a 50-game suspension) and swimmer Jessica Hardy, the linebacker did not identify the dietary supplement that cost him those starts.

Nor did he say whether he dialed the league’s little-known supplements hot line. What would the person on the other end of the phone say? How should that individual counsel a person who reportedly signed a six-year, $42 million contract in March 2008? The simple answer would be, “Do not take anything, sir, not even Flintstones vitamins. Why take the risk?”

Pro athletes probably want — and definitely deserve — a better answer. So do consumers, but that is another matter. Yes, we are all accountable for our actions. Pace said as much in a statement released by the team: “This is a situation that resulted from an over-the-counter dietary supplement that contained a substance that I did not know violated the league’s policy.  I am responsible for what I put into my body and I should have paid closer attention to the league’s guidelines.”

Having a toll-free hotline (866-635-7877 or e-mail NFLSupp@DrugFreeSport.com) helps when people think the service is good. Last season, a Minnesota Vikings player complained that he never got an answer from the independent company that manages the hot line.  Two other Vikings players have claimed that the hot line gave them the wrong information.

Athletes could look up the information themselves. The ProStar Sports Agency has a list of NFL banned substances and companies on its Web site, but it is not clear how often that directory is updated.  The bigger problem: Who knows the ingredients in a particular lot of a supplement? It is easy to stay away from the public offenders, but sometimes athletes (and nonathletes)  unknowingly ingest tainted products. They do not find out something is wrong until after their drug test results come back. Then the blame game begins. It always ends with the athlete; there must a better way.

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The criticism of supplements by SI is flawed in so many respects. Steve Mister of CRN pointed out many of the mistakes made by SI in his response at the CRN website here. I won’t repeat all his observations here. Please go to CRN’s website and read them yourself.

We read the article around here and concluded it was just more old news.   Since articles about performing enhancing drug (PED) are tired, sportswriters appear to be looking for the next big story. From the SI article it looks like they should go back to writing about PEDs. Athletes and their trainers know what works and what doesn’t. What’s banned and what’s not.

The article lacked a forward-looking angle, such as changing FDA rules or requiring manufacturers to test their products at independent labs.

Also, there was nothing about the value of traditional supplement use.  Scientific evidence supporting the use of dietary supplements to reduce the risk of disease is growing.

Meanwhile, over 70% of doctors now recommend dietary supplements to their patients.  Probably most of the SI reporters and editors take a multivitamin daily, but no mention of that in the article.

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