local

I was a bit surprised to hear Tokyo Electric Power Co. recently announced the nuclear disaster resulting from the March 2011 tsunami could have been avoided.  What surprised me was not that the disaster could have been avoided (crises so often can), nor that this contradicted earlier statements by the company that the facility was prepared for such a disaster (differing, later statements are not unusual). 

No longer will parents wonder if the bottles and sippy cups their precious little ones suck and slurp all day are wreaking havoc on their children’s developing reproductive systems.

The FDA settled the matter in last week’s announcement that U.S. manufacturers of such products may no longer use polycarbonate resins containing bisphenol-A (BPA), which some research indicates may disrupt development of reproductive and nervous systems in babies and children. The FDA issued the ban in response to the American Chemistry Council’s petition that sought the ban because manufacturers had “intentionally and permanently abandoned” BPA’s use.

For baby bottles and sippy cups, parents technically haven’t had to worry safety for years, beginning when manufacturers agreed to stop using BPA at the behest of the attorneys general of Connecticut, Delaware and New Jersey in October 2008.

What’s in it for consumers? The FDA’s decision is viewed by many as symbolic and expected to have little impact on the marketplace and consumers.

What’s in it for the BPA industry? The bigger, more subtle impact may be seen by chemical manufacturers who hope the ban will limit the collateral damage that has come to BPA with the negative publicity associated with baby bottles and sippy cups.

BPA by the billions. Every year, 2 billion pounds of BPA are manufactured/imported in U.S., and 1 million pounds are released into the environment. BPA is used in manufacturing polycarbonate plastics and epoxy resins, and nearly every industry in the United States uses it.

People are believed to be exposed primarily through food packaging, which only accounts for less than 5% of total BPA production. According to the Environmental Protection Agency, BPA is a reproductive, developmental and systemic toxicant, and as such there are questions and concerns about potential effects even at low doses or concentrations.

Little change for consumers. The new rule will not necessarily improve safety or impact consumer buying habits for these products. BPA will remain in other food contact materials because the agency supports the safety of BPA for products that hold food.  While some see this as a positive step, the basis for the ban was abandoned use, not safety.

The FDA issued the rule because its own regulations allow it to ban a food additive that is no longer in use. Mark Gardner, an attorney at DuVal & Associates whose practice focuses on FDA law, says “The FDA’s job is to protect consumers. If a chemical is no longer used in a certain application, and is even banned in China, then the FDA wants to follow suit. This is a layup for the agency. The PR fallout of not banning it in this case could have been an issue for the agency.

Industry cuts its losses. Why would the ACC seek to ban a chemical it promotes? The ACC is the chemical industry’s largest trade association, and it’s Polcycarbonate/BPA Global Group “promotes the business interests and general welfare of the polycarbonate and bisphenol A (BPA) industry.” The shots that BPA has taken over baby bottles and sippy cups may have caused enough pain for broader BPA industry that the ACC determined it was time to remove the gangrenous limb.

The ACC issued this excerpted news release and statement following the FDA's ban: “Although governments around the world continue to support the safety of BPA in food contact materials, confusion about whether BPA is used in baby bottles and sippy cups had become an unnecessary distraction to consumers, legislators and state regulators . . . . FDA action on this request now provides certainty that BPA is not used to make the baby bottles and sippy cups on store shelves, either today or in the future.”

State legislative and regulatory actions across the country had contributed to confusion about whether baby bottles and sippy cups sold in the United States contain BPA.

Two potential upsides for industry. The BPA industry may benefit in at least two ways from the new ban:

1. States will stop beating the dead horse. First, state legislative bodies will no longer need to pass laws banning BPA now that the FDA has acted. This means no more legislative hearings, no more testimony and scientific evidence about the potential toxicity of BPA and no more media reports involving BPA, babies and baby bottles. A very good thing for the chemical industry.

2. No more need to be “BPA-free.” Second, the ban could ultimately mean an end to the ubiquitous “BPA-free” on every baby bottle and sippy cup sold in the U.S. This, along with an end to the extensive information about BPA by manufacturers at websites may help industry by reducing marketplace saturation suggesting BPA is something to be “free” of.

BPA still has baggage. The baby bottle ban, however, does not end the industry’s challenges. Environmental and health advocacy groups, government regulators and industry will continue to hash out whether BPA should be removed from other food contact materials, including baby formula containers.

What’s more, BPA continues to undergo review and study from governmental agencies, including the EPA, who is studying the effect of BPA on aquatic species, how BPA enters the environment and how to reduce BPA release and exposures. 

ACC has devoted considerable resources to inform and educate the public about the safety and necessity of BPA, as can be seen from a quick preview of the ACC-sponsored websites devoted to BPA safety and benefits: http://factsaboutbpa.org, http://www.bisphenol-a.org/index.html, http://www.plasticsinfo.org/.

By removing this singular occurrence of BPA from the consumer consciousness, the ACC might be able to limit the pervasive message that BPA is potentially harming children and more effectively support and promote BPA production and use.

Follow Stacy on Twitter -- @StacyBettison

• GSK unlawfully marketed the wildly popular Paxil to children and adolescents, which had FDA approval to treat depression only for adults.  While GSK was targeting children, Paxil was flying off the shelves: Paxil sales surpassed $1.8 billion in both 2001 and 2002.  It became one of the top 10 selling drugs and for a time the most commonly used selective serotonin reuptake inhibitors.

• Wellbutrin, approved as an antidepressant, was unlawfully marketed as a wonder drug for weight loss and sexual dysfunction.  Carmen Ortiz, the U.S. Attorney for the District of Massachusetts, said GSK hired a “public relations firm to create a buzz about getting skinny and how you could have more sex simply by using this drug.” 

• For Avandia, a diabetes drug, GSK failed to provide certain safety data to the FDA so the agency could determine if the drug continues to be safe for its approved indications.

America is more medicated and spending more money on prescription drugs than ever before.  The most recent data from the Centers for Disease Control indicates that prescription use by children and adults is on the rise, and spending for prescription drugs was $234.1 billion in 2008 -- more than double what was spent in 1999. When a company like GSK is selling more drugs to more people, using fraud to sell even more drugs looks downright greedy– all at the expense of sick and suffering Americans.

Apologize, Be Visionary and Clean House.  GSK was no doubt braced for the government to make a public spectacle of the ordeal and issue a tongue-lashing.  GSK responded the right way and made little attempt to minimize or recharacterize what it did.  Indeed, there is no “positive” about a $3 billion criminal and civil fine (unless you’re the government).  The penalty is so enormous and the conduct so egregious, attempting to do anything but accept full responsibility would be wholly inconsistent with GSK’s guilty plea and settlement. 

Here’s how GSK responded: 

1.     Press release.  While a wordy headline makes no mention of “fraud” or “criminal” (nor is there an expectation that it would), GSK puts the $3 billion out front: “GlaxoSmithKline concludes previously announced agreement in principle to resolve multiple investigations with US Government and numerous states; Final settlement of $3bn covered by existing legal provisions announced in November 2011. Fundamental changes to US compliance, marketing and selling procedures implemented in recent years.” 

 2.     CEO Statement (within press release):

- Apology.  CEO Andrew Witty was apologetic, expressed regret and his intention to act in the interest of patients.  Anything short of a full scale, unequivocal apology would have been viewed as insufficient, even offensive.

- Distance between alleged conduct and CEO’s tenure.  Witty distanced GSK’s past bad acts by noting they “originate in a different era for the company,” but acknowledged that they “cannot and will not be ignored.”  Witty became CEO in 2008 – most of the alleged conduct occurred between 1999-2007.

- Focus on patients.  Witty shared his vision for that GSK’s culture focus on patients, be transparent and act with integrity.

- Corrective actions. Witty’s statement outlined what GSK is doing to fix the problems. This is critical information because the American public (and government) must be assured that GSK is cleaning house, reviewing and changing policies, and removing employees who don’t perform as expected.

- Bringing innovation to market in compliance with regulations.  Witty acknowledged the unique role GSK has in bringing innovation medicine to market in compliance with government rules and standards.

3.     Corporate Integrity Agreement. GSK entered into a Corporate Integrity Agreement as part of its settlement with the government.  Under this agreement, GSK is required to change its executive compensation program so the company may recoup annual bonuses and long-term incentives from covered executives if they, or their subordinates, engage in significant misconduct. Among other things, the agreement also requires GSK to implement and maintain transparency in its research practices and publication policies.

GSK will no doubt emerge from underneath this black cloud quickly.  As the world’s second largest drug company, it has tremendous resources to repair the damage and ensure something of this scale doesn’t happen again.  The company and its CEO have engendered tremendous goodwill in the effort to reach the world’s poorest, most neglected populations.  This bank of goodwill, coupled with what appears to be a genuine desire to do what’s right, will move GSK and its customers forward.  

Follow Stacy on Twitter -- @StacyBettison.   

Survival was the motivating factor when I trained for my first triathlon last summer. For my second one this July 14 in Minneapolis, I’m fueled less by fear of complete failure and more by the thrill of being pushed beyond my comfort zone.  As I was peddling through a 17-mile ride recently, I realized how many elements of training for a race also apply to make for a more disciplined, focused professional. Here are some insights that came to mind as I huffed on my cycle. 

Excuses, Excuses. I had a very legitimate excuse to not ride that day -- my legs and glutes ached from a workout two days previous. More rest, maybe even a big pancake breakfast (I need carbs, right?) felt like a reasonable plan. While I overcame the temptation to strap on a feed bag, it took a good deal of mental energy to get on my bike.

My Dolce Elite WSD (aka Mamasita) keeps me motivated, honest.

Imagine if we could all have a speedometer that provided us real-time data about our performance. Short of this, we benefit by collecting feedback from a wide variety of sources including co-workers, clients, even competitors. We improve by knowing where we have fallen short. By getting perspectives about ourselves from others, we find opportunities to push ourselves to achieve greater things. We may not see improvement immediately, but knowing where we can do better increases our chances of actually doing better.