Lipitor may be the first statin to switch to OTC
It's finally happening. Pfizer has placed the ball at the line of scrimmage. And based on the X's and O's to come out of its Lipitor OTC actual-use study, Pfizer will be making its run with its eye on the ultimate prize — a successful Rx-to-OTC switch of a statin.
Only this time, the Food and Drug Administration may not be as quick to sack Pfizer's switch attempt. With the advances and pervasion of health technology in the self-care space by way of smartphones and tablets; with the evolution of the pharmacist as a healthcare professional able to practice at the top of their license; and with the adoption of diagnostic tests like a cholesterol panel that can be physically administered in the pharmacy, consumers may finally get it right when self-selecting a statin.
Because it's the consumer actual-use studies that have scuttled just about every statin switch attempt in the past. In the last switch of Mevacor, FDA advisory panelists determined the statin was safe enough for the self-care space. And it was effective. It's just that the consumers who would be right for an OTC statin didn't appropriately self-select. And if they can't appropriately self-select, what's the point, really?
But that may change with this switch attempt. In fact, the FDA has already seen how technology can improve the self-selection process when it comes to statins. Two years ago, before a panel of FDA officials who were exploring how to expand what conditions would be considered appropriate in the self-care space, GlaxoSmithKline presented a prototypical healthcare kiosk that channeled a patient through nine algorithms and assisted him or her in making an appropriate treatment decision for use of an OTC statin, in this case Mevacor — branded Cardiocare. It was the kind of proof-of-concept presentation that helped showcase to FDA what the next generation of switch might look like.
Then there's the expanded switch paradigm factor. FDA just came off of a year in which it created two categories never-before-seen in the nonprescription space — overactive bladder and nasal corticosteroids. And with Merck's Oxytrol, indicated for overactive bladder, the FDA even went against the advice of its advisory panel, the simple majority of which had voted that overactive bladder was not appropriate for OTC (six were opposed, five were in favor). Proponents of the switch argued that women with overactive bladders may go years before consulting a physician and that an OTC option might encourage therapy sooner. That may be one of the tipping points for FDA — medicines available OTC, for certain conditions, may represent a greater good for the public.
And don't forget that as part of the Affordable Care Act, there is a significant cost associated with keeping statins as prescription only. You can bet the folks over at the Centers for Medicare and Medicaid Services and Tricare will be rooting for this statin switch. But then again, that's something that DSN has been saying all along. Here's what we wrote in 2011: "Under ObamaCare, the country becomes a much larger healthcare payer in 2014. OTC Lipitor could lower the cost of therapy from $4 to $5 per pill to a fraction of that — even cheaper than a generic version when you factor out the cost of the doctor visit that would be saved. The federal government stands to save a lot of money here if the Food and Drug Administration could change the way it thinks about an OTC statin."
At the end of the day, a Lipitor switch would be a significant boon to purveyors of the OTC category. Some analysts have predicted that an OTC Lipitor would become the first de facto blockbuster drug in the nonprescription space, which is defined as having sales in excess of $1 billion. Pfizer is only at the very beginning in its drive for the ultimate switch touchdown, but it's likely Pfizer will be posting seven points on the board when it's all said and done.
J&J launches Champions of Care program in support of its 2014 FIFA World Cup sponsorship
NEW BRUNSWICK, N.J. — Johnson & Johnson, the official healthcare sponsor of the 2014 FIFA World Cup, on Thursday announced the launch of the Champions of Care program in the United States to shine a spotlight on people who go above and beyond to do extraordinary things in caring for others.
Developed by J&J in support of its 2014 FIFA World Cup sponsorship, the Champions of Care program invites individuals across the country to celebrate the most caring people in their lives. The need for the program was supported by findings from a nationwide survey conducted by Johnson & Johnson to better understand Americans’ sentiments on caring. The survey indicated that more than half (52%) of Americans believe that our nation has become less caring over the past five years. Further, the research found that 9-out-of-10 Americans believe that caring should be encouraged more in our society and that everyone can find an extra five minutes a day to show they care, and inspire others through their actions.
Based on the J&J philosophy that one act of care can inspire another and ultimately, create a more caring world, the program invites individuals to visit CareInspiresCare.com beginning today through April 4 to share their own Champions’ stories and nominate them as Champions of Care. From these stories, six finalists will be selected and profiled. Public voting will occur from May 5 to May 25 to select the grand prize winner who will attend the 2014 FIFA World Cup final match in Rio de Janeiro on July 13.
"As the world comes together this summer for the FIFA World Cup, J&J will honor those who selflessly care for others each and every day," stated Holly Means, VP corporate equity strategy and sponsorships, J&J. "Through Champions of Care, we will share inspiring stories and recognize those who make a real difference in their communities and the lives of many around the world."
Karla Martinez, co-host of Univision’s Despierta America, was named ambassador for the Champions of Care program in the United States and helped launch the program at a primary school near Miami. Martinez and youngsters from the South Hialeah Elementary School became the first Champions of Care ambassadors in the United States, packing book bags in support of Save the Children’s "Early Steps to School Success" program. The books will be donated to children in need across the United States. Over the next four months leading up to the 2014 FIFA World Cup, Martinez will be traveling with J&J to other markets across the country to participate in events that celebrate and encourage simple acts of care in our everyday lives.
"As a wife, mother and member of my local community, I am proud to partner with Johnson & Johnson on the Champions of Care program to show that even a small act of care can make a difference in people’s lives and can inspire others to do the same," Martinez said. "My personal Champion of Care is my grandmother, who has put other people before herself throughout her life. Driven by her example, today I want to inspire others to perform more acts of care."
The Champions of Care program is a key element of the J&J Care Inspires Care campaign, based on the belief that one act of care can inspire another and, ultimately, create a more caring world. As part of its Care Inspires Care campaign, J&J also is inviting people to share their caring stories on the Care Inspires Care Facebook page. Every post, like and share to #JNJ and #inspirecare will be tracked via the "Caremeter" on the page with the goal of reaching 50 million "cares" this year. Reaching key milestones will trigger a donation to global NGO partner Save the Children and be celebrated throughout the months leading up to the 2014 FIFA World Cup.
Through Care Inspires Care and as the Official Healthcare Sponsor of the FIFA World Cup, J&J aims to foster caring among people every day, provide resources to help care for and enable a healthier future for the families and communities in Brazil, and support and care for the fans, volunteers and players at this year’s tournament.
Hero Nutritionals’ Slice of Life Sugar Free Multi+ recognized for low glycemic impact
SAN CLEMENTE, Calif. — Hero Nutritionals on Thursday accepted the 2014 Taste for Life Essentials Award for its Slice of Life Sugar Free Multi+, a gummy vitamin and mineral supplement for adults. Naturally sweetened from fruit, Slice of Life Sugar Free Multi+ gives consumers a gummy vitamin option for adults that is made without any sugar alcohols or artificial sweeteners.
Slice of Life Sugar Free Multi+ was recognized by Taste for Life magazine due to the low glycemic sweetening ingredient, Lo Han Fruit, also known as Monk fruit, which has no calories and is 300 times sweeter than sugar, yet does not elevate insulin levels. “It is an honor to continue in the Hero tradition of providing ‘firsts’ to the health-conscious consumer with the first truly healthy and great-tasting sugar-free gummy multivitamin,” stated Claire Polson, Hero Nutritionals’ national sales manager.
The multivitamin blend of Slice of Life Sugar Free Multi+ includes lutein and lycopene, which support eye health, and chromium to help maintain healthy blood-sugar levels. The formulation also includes 16 vitamins, including vitamins A, C, D, E and B-complex vitamins.