Over the Bush II years, I had a persistent and serious problem with their primary PR hacks and politicos incessantly interfering with science, and attempting to remake it in their political interests. The most notorious example was in their re-writing and excision of data from an EPA report in 2002 to try to wash out all the evidence for global warming. But there were others, including their noisome efforts in 2004-05 for preventing the over the counter sale of "Plan B" day after contraceptives. In effect, "playing politics with women's health by denying emergency contraception for over the counter sales" in the words of Nancy Northrup, President of the Center for Reproductive Rights which sued the FDA over it in 2005.
Well, the FDA, after many tribulations and false starts, finally appeared to get its act together and approve the Plan B for younger teens without a prescription when Health and Human Services Secretary Kathleen Sebelius stepped in and overruled the FDA - the first time ever in living memory. FDA Commissioner Margaret Hamburg was prepared to remove the current requirement that girls under 17 needed a prescription (and doctor's visit) for the pill, manufactured by Teva Pharmaceutical Industries, Ltd. when the HHS stepped in and blocked it.
This is despite the fact that Teva had submitted two comprehensive studies, one to ascertain if the girls under 17 could understand the labeling, and the other designed to simulate real world use of the product. The findings were, according to Amy Niemann (Teva VP) that 90% of the girls were able to make judicious use of the product.
Having myself worked a short stint (1993- 95) as an FDA documentation adherence specialist (for a radiotherapy software corporation), I know how difficult the threshold is to attain a product that is "safe and effective". I also am aware of the extent of scientific testing that goes into it. This means that if a product is FDA-approved it should be at that threshold or beyond. Yes, the FDA has had lapses, but those need to be examined against the total background of products, varieties of pharmaceuticals it tests, and also bearing in mind how its budget has been pared back under Repug, anti-regulatory rule....especially during the Bush II years.
Ms, Sebelius, for her part, claimed that the label comprehension and actual use study "didn't include data on all ages for which the drug would be approved and over the counter", but this is a bare bollocks cop out and PR feint. It doesn't wash, especially as Hamburg of the FDA noted that its drug review specialists, including pediatricians and obstetricians, "reviewed the totality of the data and agreed ...it should be approved for all females of child-bearing potential".
So how is it that a political appointee purports to know more than these experts with their decades of expertise? In point of fact, she doesn't. This is simply a plain political trumping of science as egregious in its own way as the Bushies trumping of climate science with their own political hackery and reality-revision.
But Obama and his administration ought to be above these games. Further, there is not one damned dot of evidence to prove or show he will gain one more vote from any Catholic or Evangelical by going this route. Indeed, whatever paltry few votes he does gain will likely be offset by votes lost by outraging liberal women's advocacy groups! So why do it? Why not just stand on scientific principle and courage? Why not allow the FDA, as the putative agency overseeing these issues, to have the final say?
Maybe the reason is fear. Fear that it will become a "political football" in 2012. But a real politician, President or party can't control every conceivable issue on every front by political manipulation. Sometimes, you have to master and sustain backbone, and let the chips fall where they may, as opposed to interference. Oh, it also helps if you're splendid on articulating the basis for a decision or an agency decision, without pandering to special (religious) interests in an election year. Make your case the best you can, put it out there, and fuck those who don't accept it. That's their problem! You can't control how everyone thinks or how they take or interpret every last decision by every agency under your purview! Or......how they vote, assuming they do!
At the bottom of it all, NO political party or President ought to be seen to kowtow to a religious group, or religious voters, I don't care how badly those votes are desired. People will see through that anyway and you're no better off. Indeed, the general welfare provision in the Preamble of the Constitution trumps all these political maneuvers since the more kids our teens have out of wedlock, the fewer national resources for all other needs. It's a zero sum game after all, no matter how much the PR mavens try to eradicate that fact.
Ultimately, the best move HHS, Ms. Sebelius and the Obama administration can make now, this very second, is to recall that ill-advised decision to trump the FDA, and to stand forthwith as defenders of science.....devil take the hindmost!
Well, the FDA, after many tribulations and false starts, finally appeared to get its act together and approve the Plan B for younger teens without a prescription when Health and Human Services Secretary Kathleen Sebelius stepped in and overruled the FDA - the first time ever in living memory. FDA Commissioner Margaret Hamburg was prepared to remove the current requirement that girls under 17 needed a prescription (and doctor's visit) for the pill, manufactured by Teva Pharmaceutical Industries, Ltd. when the HHS stepped in and blocked it.
This is despite the fact that Teva had submitted two comprehensive studies, one to ascertain if the girls under 17 could understand the labeling, and the other designed to simulate real world use of the product. The findings were, according to Amy Niemann (Teva VP) that 90% of the girls were able to make judicious use of the product.
Having myself worked a short stint (1993- 95) as an FDA documentation adherence specialist (for a radiotherapy software corporation), I know how difficult the threshold is to attain a product that is "safe and effective". I also am aware of the extent of scientific testing that goes into it. This means that if a product is FDA-approved it should be at that threshold or beyond. Yes, the FDA has had lapses, but those need to be examined against the total background of products, varieties of pharmaceuticals it tests, and also bearing in mind how its budget has been pared back under Repug, anti-regulatory rule....especially during the Bush II years.
Ms, Sebelius, for her part, claimed that the label comprehension and actual use study "didn't include data on all ages for which the drug would be approved and over the counter", but this is a bare bollocks cop out and PR feint. It doesn't wash, especially as Hamburg of the FDA noted that its drug review specialists, including pediatricians and obstetricians, "reviewed the totality of the data and agreed ...it should be approved for all females of child-bearing potential".
So how is it that a political appointee purports to know more than these experts with their decades of expertise? In point of fact, she doesn't. This is simply a plain political trumping of science as egregious in its own way as the Bushies trumping of climate science with their own political hackery and reality-revision.
But Obama and his administration ought to be above these games. Further, there is not one damned dot of evidence to prove or show he will gain one more vote from any Catholic or Evangelical by going this route. Indeed, whatever paltry few votes he does gain will likely be offset by votes lost by outraging liberal women's advocacy groups! So why do it? Why not just stand on scientific principle and courage? Why not allow the FDA, as the putative agency overseeing these issues, to have the final say?
Maybe the reason is fear. Fear that it will become a "political football" in 2012. But a real politician, President or party can't control every conceivable issue on every front by political manipulation. Sometimes, you have to master and sustain backbone, and let the chips fall where they may, as opposed to interference. Oh, it also helps if you're splendid on articulating the basis for a decision or an agency decision, without pandering to special (religious) interests in an election year. Make your case the best you can, put it out there, and fuck those who don't accept it. That's their problem! You can't control how everyone thinks or how they take or interpret every last decision by every agency under your purview! Or......how they vote, assuming they do!
At the bottom of it all, NO political party or President ought to be seen to kowtow to a religious group, or religious voters, I don't care how badly those votes are desired. People will see through that anyway and you're no better off. Indeed, the general welfare provision in the Preamble of the Constitution trumps all these political maneuvers since the more kids our teens have out of wedlock, the fewer national resources for all other needs. It's a zero sum game after all, no matter how much the PR mavens try to eradicate that fact.
Ultimately, the best move HHS, Ms. Sebelius and the Obama administration can make now, this very second, is to recall that ill-advised decision to trump the FDA, and to stand forthwith as defenders of science.....devil take the hindmost!
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