Opening Day Versus Muscular Dystrophy: White House Petitions and the Flaws in Society

The recent push by Budweiser and Major League Baseball to have Opening Day of the baseball season declared a national holiday or national day of observance hit a new milestone, as was widely reported in the media yesterday, the petition to The White House hit 100,000 signatures.

 

This number was reached well ahead of the 30 days required to attain the threshold for White House consideration. The background description for the petition references the notion that Opening Day is also the start of Spring and a time of renewal for the American people, and that creates further merit to that day being a day of observance for the nation.

 

Now, I enjoy watching Major League Baseball just as much, if not more, than the average American. I attend games, listen on the radio, and watch a great deal of out-of-market games as well. I find the pace of the game relaxing, and the battles between the pitcher and batter fascinating.

 

However, I do not feel that the Opening Day of the professional baseball season should be a national holiday, and I have made this opinion well known on social media, where MLB and Budweiser have promoted this effort heavily, especially on Facebook.

 

This is a blatant attempt by Budweiser to sell even more beer by having a captive audience of Americans for Opening Day games, many of which are played in the afternoon during regular working hours. The interest by MLB is clear, while the attendance level and ticket sales demand has always been robust across all the markets in the league on Opening Day; they will have a new audience of TV viewers if everyone is home from work that day. The ratings will drive up as well the advertising revenues for these first games.

 

An additional benefit for Budweiser will be heavier bar and restaurant traffic on Opening Day if it is a national holiday. That will mean increased profits for the beer making giant.

 

A Stalled Cure

 

In the meantime, this month also featured another petition to The White House that my sister alerted me to recently regarding the potential cure for Duchenne Muscular Dystrophy.

 

This petition seeks help from The White House in gaining Accelerated Approval for a drug that has shown incredible progress in the reversal of symptoms for patients with Duchenne Muscular Dystrophy who are suffering tremendously.

 

Duchenne Muscular Dystrophy effects 1 in every 3,500 boys in the United States. The condition results in muscle degeneration and over the course of time, death. The average life expectancy is 25, and the disease rapidly deteriorates the muscle mass in the legs and pelvis and progresses up the spine and neck.

 

The Food & Drug Administration (FDA) has been reluctant to mark this important drug with even limited approval despite promising data from successful clinical trials with the drug. The parents and relatives of those suffering with the disease are pushing this effort for Accelerated Approval forward.

 

However, through no fault of their effort, the promotion for this petition has been largely through grassroots e-mail distribution and has far less social media exposure than the promotion that Budweiser is committing toward the Opening Day holiday petition.

 

This petition is trying to solve a critical issue, what can mean literally life or death for people, and the cure is being delayed and stalled in the FDA. Their petition is struggling in the month of March to gain even a few thousand signatures while the Opening Day petition has 100,000 names on it.

 

A Flawed Society

 

This whole situation is a microcosm of our flawed society in America. The effort is there behind something rather trivial in having Opening Day as a national day of observance, while the effort to gain approval of a drug to deal with a horrible disease is not on anybody’s radar screen.

 

The effort behind getting the petition for the Duchenne Muscular Dystrophy drug approval accelerated is called “The Race to Yes” and further information can be found on their site: http://www.theracetoyes.org where you can also access the link to the petition for this critically important effort.

 

I also wonder how the victims and families of those lost on 9/11 feel about the Opening Day situation. I expressed on social media their prior attempts for federal government support for 9/11 to be a national day of observance, a day where people would be off from work and would be requested to perform an act of service to the community on that day.

 

I think we all can take a very educated guess on how the victims and families of those lost on 9/11 feel about this situation. Could you imagine working on getting this type of recognition for 9/11 and the Opening Day petition gets to 100K signatures, being pretty upset would be an understatement, that is what is wrong with American society: the emphasis on things that are not important.

 

Counterpoint

 

In fair balance, MLB does an incredible amount of charitable work and community service, particularly in the markets where the league has franchises, which is essentially all of the major cities of the United States. I am sure that Budweiser, and their parent company, AB InBev, conduct a large amount of community service and charitable giving as well.

 

In addition, Major League Baseball was and still is a very generous supporter to 9/11 related charities for the families of the victims and for the police, firemen, and other first responders and their families. Those games of baseball played just after that tragedy helped myself and many others return to normalcy after such a horrible and traumatic event.

 

Budweiser is looking to enhance baseball which is an incredible profit generator for their company, and they are well within their rights to do so. It just does not mean that I have to agree with their pursuit of this Opening Day petition.

 

In fairness, the rationale behind the FDA not providing at least a limited approval of the Duchenne Muscular Dystrophy drug could be indicative of a potential issue with the drug. Although I could not find any reports of adverse events, side effects, or discontinuations regarding the drug in my review of the clinical study data.

 

Regardless of the rationale, the fact remains that the FDA has not moved on a drug that could represent the best opportunity for these children to have a better quality of life with a horrible disease. An explanation from the FDA to the families of those afflicted regarding the reason for the delay would probably be a good idea for someone at the FDA to pursue at this point.

 

 

Outlook

 

In the end analysis, the petition process via The White House web site has plenty of worthwhile causes vying to receive some sort of assistance from the federal government to progress their respective cause.

 

I feel that these issues I mentioned and others deserve some merit and attention and that the Opening Day holiday petition is completely unnecessary. The American society has holidays in place where we can all sit around drink Budweiser and watch baseball already which are called Memorial Day and Labor Day. We have days off of work where we can watch baseball and have a beer too: it is called the weekend. Another holiday for baseball is not needed.

 

A cure for a disease effecting children is vitally needed, and others days of observance or service such as 9/11 would enhance our society. To borrow a phrase from baseball it is time for Americans to “keep their eye on the ball” and focus on the issues that really necessitate federal government support.

 

(Statistics and background info courtesy of NIH, www.muscular-dystrophy.org and www.theracetoyes.org  Opening Day info courtesy of UPI and Facebook)

 

 

 

Dangerous Marketing: U.S. Energy Supplements

The U.S. energy supplement market represents big dollars for the companies involved not only from a manufacturing and distribution perspective but for the suppliers of the ingredients for their respective formulations. We are all familiar with the seemingly constant stream of commercials and late-night TV infomercials on these energy products.

 

The rapid success of some of these products is driven by the large scale marketing campaigns to create demand among a range of American consumer groups. Some of the promotional activity in the energy supplement market focuses on the “clinical trial data” and might feature a sound bite from a doctor or someone in the medical community endorsing the effectiveness of the product.

 

 

Oregon’s energy supplement battle

 

The State of Oregon has been involved in legal action against the makers of the energy supplement 5 Hour Energy due to a mounting number of adverse events allegedly linked to the consumption of the product.

 

The FDA has reports of such adverse events as spontaneous abortions, heart attacks, and 11 fatalities which involve people who regularly used the energy supplement. The State of Oregon decided that they needed to take legal action against the manufacturer of the product, and during the course of the process they requested data on the ingredients in 5 Hour Energy.

 

The manufacturer of the product responded by sending a list of ingredients with the specific amounts redacted from the documents. A judge recently ordered the manufacturer of this supplement to produce the documents with the specific amounts of the ingredients disclosed for the Oregon Department of Justice by February 15th.

 

The main issue here is that the regulatory process on a vitamin or energy supplement is much different than the regulations on a food or a drink. The FDA has a far more stringent policy for the submission of a new food product than the process which exists for vitamin or energy supplements. The energy beverages such as 5 Hour Energy are considered dietary supplements and are not held to the more stringent standards of a traditional beverage product.

 

In light of the alleged case against 5 Hour Energy and other similar supplements the testing and approval process for these products needs to be revamped. The increased pressure from the court of American public opinion could accelerate those changes in 2014.

 

Across the spectrum

 

The use of energy drinks and energy supplements is prevalent across the spectrum of ages and demographics. In a study by The Journal of Nutrition it was noted that of all the sugary drinks consumed by teens and children, 8.8% of those beverages consumed were energy drinks.

 

In a related report from Packaged Facts, the consumption of energy beverages by ‘’Baby Boomers” was correlated based on sales data which indicated a sharp increase in sales of 5 Hour Energy to that demographic. The report continued by noting that “Baby Boomers” represent 2/3 of the U.S. population, have enormous spending power, and are seeking energy boosts to maintain an active lifestyle.

The potentially dangerous effects of consuming these energy beverages or supplements has resulted in increasingly high incidences of health related adverse events. In fact, a study by the Department of Health & Human Services (H.H.S.) reported that hospital emergency room visits concerning the consumption of energy drinks doubled from 10,000 to 20,000 from 2007 to 2011 (www.hhs.gov).

In fair balance, it is also largely unknown how many cases regarding these medical incidents may be caused by misuse of the supplement or overconsumption of the energy drinks in question. In that case, then the labels of the products need to have clearer directions listed for the safe use of the product, and warnings should be more explicit on the potentially harmful effects caused by overindulgence in the product.

However, in either case, a resolution needs to be formulated to address this situation before the incidences increase in proportion to the consumer population involved.

Multi-faceted solution

 

The dangers stemming from the consumption of energy beverages or similar energy supplement products are becoming too big to ignore. Some of the companies involved are reportedly concerned that the continued stream of negative news regarding these products could threaten to damper the growth of this industry segment.

 

The solution, given my experience in the food industry, should be a multi-faceted approach where the F.D.A. as well as Congress and other entities work together to increase awareness of the potential adverse effects associated with these energy supplements.

 

The F.D.A. should continue to issue warnings to the manufacturers of these types of energy products. Congress should work to find a way to close the loophole and provide the F.D.A. with the proper pathways to exert better oversight over the regulations to better safeguard the manufacturing of these products.

 

The judicial system can get involved on the state level to advocate for the consumer regarding the ingredients involved in these energy supplements, and the case in Oregon will go a long way in determining how these matters will be addressed by the courts in the future.

 

A public service campaign geared toward all demographics is needed to raise awareness of the potential side effects from these types of products.

 

Finally, the manufacturers themselves could help their own cause by being forthright with the data requested, and by being more transparent.  If all of these entities worked together, and the right level of awareness about the consumption and correct use of these products was communicated, then these types of medical events could be potentially avoided in the future.