Glee, Christmas Miracles, and the FDA

Let's talk Glee. There are a number of things that are realistic on that show. People can sing. People can dance. BUT people cannot find Rewalks under their Christmas trees in the United States of America.

Sorry, Artie. Source*

Why? The easy answer is that the FDA hasn't approved it yet. That could be because of concerns that the V.A., Medicaid, and other payers may not be able to fund an expensive device like the Rewalk Personal. But the FDA's refusal to approve it clearly flies in the face of its mission statement to "protect and advance" public health. While the FDA has approved Rewalk Rehabilitation, a model only used in medical facilities, it has remained quiet about its plans regarding the Rewalk Personal, which individuals can take home to use where and when they please. 

The issue came up recently during President Obama's visit to Israel. As the President viewed a demonstration of the Rewalk by two disabled veterans (U.S. Sgt. Theresa Hannigan and Israeli soldier Radi Kaiuf), Rewalk's creator, quadriplegic Dr. Amit Goffer, had this to say:

“This device is already improving the quality of life for many people and we look forward to seeing its continued expansion around the world including in the US where we are awaiting FDA clearance for daily personal use.”

In other words, it is a shame that Americans who are disabled cannot join the over 100 individuals in Europe and Israel who are currently benefiting from the device. 

In my first post, I asked what the price of FDA interference and so-called protection is in terms of time, efficiency, and money. Here, it is clear that the effects of FDA inaction go beyond that. There are people sitting at home right now who could be walking, or at least raising money to be able to walk, as this man is trying to do in Leicestershire, England, or as Claire Lomas, a British athlete, succeeded in doing. Dr. Goffer, who was inspired to create Rewalk because of his own struggle with paralysis, said he hopes costs will go down soon as the company shifts to mass production. He also stated that Rewalk does much more than merely improve people's fitness. As one woman stated, the best part is being able to speak to other adults at eye level. Why is the FDA holding people back from improving their health and emotional well-being? 

Claire Lomas breaking old boundaries at the London Marathon thanks to Rewalk. Source*

I can think of only two possibilities. Either Rewalk Personal is sitting on a desk somewhere and FDA employees are too busy measuring caffeine in syrup to bother with it, or they are waiting for the device to gain enough traction and popularity in Israel and Europe to enable the company to shift to mass production so that the costs will be lower by the time it hits the American market. In the meantime, it is one less thing to worry about fitting into Obamacare. 

Obama and the Morning After

Here is a telling excerpt from a HuffPo article today:

"The FDA was preparing in 2011 to allow over-the-counter sale of the morning-after pill with no age limits when Health and Human Services Secretary Kathleen Sebelius overruled her own scientists in an unprecedented move."

In all the hullabaloo about the "morning-after" pill being available to fifteen-year-old girls, it is not widely reported that, back in 2011, the FDA was fully prepared to approve its use for ANY woman of child-bearing age, though it did not specify what that age was. It was prevented from doing so by Health and Human Services Secretary Kathleen Sebelius, and her decision was overruled by New York Judge Edward Korman. Since Korman's ruling, the FDA has agreed to make the morning-after pill available without a prescription to girls who are fifteen and older.

While there has been some controversy over the FDA action, people don't seem to realize that the FDA would have been willing to make the pill available without a prescription to virtually any pre-teen in 2011. 

There is an incredible amount of politicking that went into this "scientific" decision, so much, in fact, that it is hard to know where to start pointing fingers. Is Obama at fault? He claimed to be "very comfortable" with the FDA's recent court-ordered action, but it was his secretary who opposed it. Is the judge at fault? He was merely reinforcing the FDA action from 2011. Is it Secretary Sebelius, who interfered with the FDA's scientific work, or was it a bad decision on the part of the FDA which she was right to oppose?

The furor over the FDA's move overlooks the complicated dance that led up to it. Why did Sebelius stop the FDA's action in 2011? Was she afraid it would be too controversial and make her department look bad, even though she may have been relatively secure that her objection would be overturned in court? Why is Obama "comfortable" with a ruling that his own Department of Justice is seeking to appeal? My sense is this a highly political game in which the Obama administration is attempting to sidestep controversy in a confusing and, for many, disturbing development.

A quick timeline:

• 2011: FDA prepares to approve Plan B without a prescription for "all females of child-bearing potential."
• December 2011: Health and Human Services Secretary Sebelius invokes her authority and stops the FDA approval of non-prescription Plan B for "all females of child-bearing potential".
• Reproductive rights organizations seek to overturn Sebelius's decision.
• 2013: New York Judge Edward Korman overturns Sebelius's decision, claiming it was  "politically motivated, scientifically unjustified and contrary to agency precedent."
• 2013: FDA approves non-prescription Plan B drug for females aged 15 and older. President Obama says he is "very comfortable" with the FDA decision.
• 2013: Obama's Justice Department seeks to overturn Judge Korman's ruling, in contrast to Obama's apparent endorsement of it.

Contraception, under-age sex, and abortion can all be tricky political issues, and President Obama might not have wanted those issues playing out during election season. It is possible that he wanted Sebelius to do what she could to delay this issue from coming to the fore until after the presidential election.