Tuesday, January 3, 2017
It’s a new year and people fill it with resolutions to eat better, work out a little more, get in shape and be healthy. As January 1st shows up in the rear view mirror, the best intentions fall nu the wayside and sometimes people turn to a pill or supplement as an opportunity to regain momentum or perhaps replace the time and effort that being healthy entails.
When an athlete fails a drug screen, the response and excuse often is that the pill/powder/liquid was adulterated. The athlete did not know what was in the supplement or medication and there was no intent to cheat or gain a competitive advantage. Aside from Lance Armstrong and the recent Russian sports machine drug abuse indictment, most athletes have their transgressions and suspensions forgotten with time. Sammy Sosa, Barry Bonds and Roger Clemens are on the ballot for Cooperstown. But the reality is that role models do affect public behavior and the New Year has a few stories that are reminders that performance enhancement opportunities are wide spread and can be dangerous.
Caffeine jump starts the world in coffee, soda and also in energy drinks. That is not necessarily a good thing, because the concept of “everything in moderation” can be overwhelmed by “if a little is good, a lot must be great.” Research from the US military has found that energy drink abuse leads to sleep pattern disturbances and is associated with service members falling asleep on duty. The conclusion of a Walter Reed study of more than 1, 000 soldiers found that energy drinks are “unregulated and can have negative side effects…those who had three or more drinks per day were more likely to fall asleep during briefings or on guard duty.” The authors of the report also concluded that the long term effects of larger doses of the ingredients in energy drinks is not known. Imagine if the FDA released the same statement for a prescription drug.
The Armed Forces report deals with adults but what about supplements that are being advertised and supplied to kids? The American Academy of Pediatrics has a policy position recommending against the use of creatine and testosterone products in the pediatric (under 18) population. But what stops a middle or high school athlete from walking into a health food store and buying products that have not been found safe for their use…it seems absolutely nothing. Research to be published in the Journal of Pediatrics found that health food sales people had no trouble recommending creatine and testosterone boosters to researchers posing as a 15 year old high school athlete. There are no laws that prevent such recommendations or sales. Trusting the recommendation of a supplement shop sales clerk is not the same as a discussion with a pharmacist.
So who cares? The supplement manufacturers should maintain strict standards as to what is in their product and the consumer should be reassured that the product label accurately lists what is contained in a pill or powder. If only the consumer could be that certain. It remains a buyer beware marketplace. In 2015, the New Your Attorney General’s office found that Walgreens’ Walmart, Target and GNC all had supplements on their shelves that did not contain the ingredients that were documented on the label. Almost 80% of the supplements did not contain the medicines they were supposed to, but instead included “cheap fillers like powdered rice, asparagus and houseplants, and in some cases substances that could be dangerous to those with allergies.” The story made headlines for a day or two as the stores agreed to reach out to their suppliers. After another New Year has passed, how that story has played out is uncertain.
For all the criticism leveled at the Federal Drug Administration, at least the US public can be reassured that the medications prescribed by a physician and dispensed by a pharmacist, will have the ingredient in the pill that is labelled on the bottle. The same holds true for hundreds of over the counter medications like aspirin or Tylenol and their generics. While we might not like the ads or commercials of some drugs, at least we know that their labs and production facilities are regulated to a high standard. When it comes to herbal supplements…not so much. It’s very much a buyer beware marketplace.This entry was tagged caffeine, creatinie, FDA, herbal supplements, regulation, side effects, supplement
Sunday, August 2, 2015
Elite athletes know their bodies well. They understand the signals that push them to perform and those that may cause potential damage and injury. They also know that what they put into their body for fuel is an important part of the equation. For that reason, an athlete who tests positive for a performance-enhancing drug, can reasonably presume that it was illegal. So it was not unreasonable to hear the collective sigh of disbelief, when Antonio Gates of the San Diego Chargers told reporters that he was shocked when he failed his drug test. Mr. Gates said he was not quite sure how the illegal drugs got into his body but he had not necessarily changed his routine and had never before tested positive.
Fans may roll their eyes and stare in disbelief, but Mr. Gates may be the victim of the dietary supplement and alternative medication industry that has grown without oversight and regulation. While pharmaceutical companies are held to stringent production and distribution standards by governmental agencies around the world, those companies who tout the benefits of their “nutraceuticals” can do so because of large loopholes found in the Food and Drug Administration (FDA) regulations. There is no guarantee that what is listed on the label is actually contained in the pill.
This year the New York attorney general’s office found that the majority of herbal supplements tested did not contain any of the herbs listed on their labels. These were supposedly reputable brands sold at major retailers like Walgreens, Target, Wal-Mart and GNC. This was not necessarily news, since past studies had documented similar inaccuracies. Not to be outdone, this month, the Department of Justice sued three Wisconsin manufacturers (Atrium, Nutripak and Aspen Group) for mislabeling multiple supplements and because it was a repeat offense, asked that they be continually monitored at company expense by the FDA. European researchers found that more than 10% of dietary performance supplements were contaminated, often with steroids and other stimulants (Judkins, C. Investigation into supplementation contamination levels in the UK market. HFL Sport Science 2008).
So why does this matter and why should we care what a pro athlete puts into their body? The answer is relatively simple. Dietary supplements are not innocuous. They can have significant side effects if take inappropriately and may also interact with prescription medications to cause problems.
Excessive caffeine can affect blood pressure, heart rates and rhythms. St. Johns Wort can interact with blood thinning drugs to decrease their effectiveness and lead to increased risk of stroke. Bodybuilding and weight loss supplements contain chemicals and proteins that may stimulate increased production of anabolic steroids in the body, increasing the risk of liver disease, cancer and other illnesses. Some, like androstenedione, were available for years before being banned by the World Anti Doping Agency and other pro sport organizations. Other chemical supplements are now marketed to take their place. Plus, there is the potential for contamination in the manufacturing process. A hepatitis outbreak in 2013 was related to the weight loss supplement OxyElitePro. In 2014, the probiotic, ABD Dophilus Powder, was found to be contaminated with fungus.
While all manufacturers should not be painted with the same brush, industry lobbied hard for Congress to exempt them from the tighter FDA regulations that are imposed on pharmaceutical companies. In 1994, Congress exempted supplements from the FDA approval process required of pharmaceutical companies. In 2012, an amendment to register products with the FDA and list their ingredients was defeated. Now, all the FDA can do is ask that makers of dietary supplements voluntarily adhere to good manufacturing practices and guarantee the identity, purity, strength and composition of their product.
The National Institutes of Health notes that “research studies in people to prove that a dietary supplement is safe is not required before the supplement is marketed…the manufacturer does not have to prove that it is effective.” Dietary supplements cannot be marketed to treat, prevent or cure a disease or illness. Therefore, the weight loss or male sexual enhancement claims are not meant to treat obesity or erectile dysfunction. Supplements developed to regulate acid secretion or bowel habit are not directed to peptic ulcer disease or constipation.
With the inaction by Congress and the FDA, other companies have filled the void. NSF International will certify products as safe, containing what the label says it does, and sports leagues like the NFL accept that certification. But it is a leap to say that the manufacturing standards of dietary supplements meet those of pharmaceutical companies, without the stamp of approval of a governmental agency. And while it is sometimes hard to believe the explanations that athletes give for failing a drug test, it is a distinct possibility that Mr.. Gates did nothing wrong and was the victim of circumstance beyond his control.
For Mr. Gates, the potential lack of manufacturer accountability led to a missed paycheck. For those who developed hepatitis or a fungal infection, or had a heart attack or stroke, the loss was much more tangible. Without aggressive FDA oversight and action, the self-regulation in the industry will only get better only if the risk of an expensive lawsuit outweighs the benefit of increasing their standards. And that’s asking a lot for a company to balance corporate ethics against their bottom line.This entry was tagged Antonio Gates, Congress, contamination, dietary supplement, FDA, over the counter medications