Sunday, August 28, 2005

Another Loss for Science in America!

America is slipping into the Dark Ages under this President.

Evolution is at risk and the Bible is replacing Darwin for Scientific Understanding of Mankind.

Our government, through voucher programs, is expanding its support for religious education. And Faith-Based welfare programs are mixing Jesus with personal assistance.

Embryonic stem cell research is denied Federal support and scientists leave America for other countries where they can pursue their research.

It is a "bad hair day" for Science in America!

"Abyss" from University of Oregon Website

And now the 'theocrats' have hijacked the Food and Drug Administration, denying America's women the right to a morning after medication for emergency contraception to prevent unplanned preganancy and to reduce the need for abortions!

The Food and Drug Administration mission statement:
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
Note the inclusion of "science-based" information. It didn't say anything about seeking consultation with religious leaders on what is appropriate for America's health!

One of the mechanisms it performs this function is through advisory panels. Linda Ann Sherman, the Director, Advisory Committee Oversight & Management Staff, explains the committee's role:
The advisory committees’ role is to offer the
FDA the very best advice possible on related questions
posed by the Agency on a product of regulated
industry. It is important to understand that
the committee’s function is to give advice; however,
the Agency is not bound to follow that advice.
This is exactly the situation that arose in 2003 in regards to the controversial Emergency Contraception medicine produced by Barr Laboratories. As reported:
On December 16, 2003, a joint hearing of the FDA Nonprescription Drugs and Reproductive Health Drugs Advisory Committees voted 23 to four to recommend that the FDA make EC available over the counter. Virtually all major medical and health care organizations, including the American College of Obstetricians and Gynecologists, supported the move.

But on May 6, 2004, in flagrant disregard of this scientific consensus, the FDA notified Barr Laboratories, which manufactures Plan B, that its application for over-the-counter status had been denied, citing concerns about adolescent use. It conveniently overlooked studies showing that EC is safe for younger women and that they use EC responsibly. Studies also show that access to EC does not increase or encourage sexual activity among teens.
This was such a controversial subject that the confirmation of Lester Crawford, the FDA chief currently, was held up until assurances were give to Senators Hillary Rodham Clinton (D-NY), and Patty Murray (D-WA):
"Senators Hillary Rodham Clinton (D-NY) and Patty Murray (D-WA) lifted the hold they had placed on his nomination after receiving assurances that the FDA would rule by September 1 whether to grant over-the-counter status to Plan B."
But they didn't rule on Plan B.

I guess they are sorry for misleading the American people.

But the FDA failed to make a decision, and in effect delayed again this medication that can reduce the need for abortion in young American women. As reported in the L.A. Times on August 27, 2005:
WASHINGTON — Federal regulators Friday balked at deciding whether to make the "morning after" birth control pill available without a prescription, saying that, though it is safe, proposed restrictions on teenage girls' access to the drug have raised legal issues.

The Food and Drug Administration had promised a decision on the politically charged question by next Thursday. But FDA Commissioner Lester Crawford said he was postponing a decision until the agency could formally gather comment on whether age is a valid justification for requiring girls 16 and younger to get a prescription for the contraceptive, which is marketed under the name Plan B.
In a statement of August 26, 2005, FDA Commissioner Lester M. Crawford reported :
The issues that we were asked to resolve, and the proposal that was put forward by Barr Labs, presented us with many difficult and novel policy and regulatory issues.

In some cases, the questions we were asked to answer were unprecedented for this agency. In particular:

Can age be used as a criterion on which we decide whether a drug should be prescription or over-the-counter, as has been proposed in this case?

Can the prescription and over-the-counter version of the same drug be marketed in a single package?

In addition, if we do use age as the only criterion on which we decide whether a drug is sold as a prescription product, or an over-the-counter product, how, as a practical matter, would such a limitation be enforced?

These are profound regulatory decisions that cut to the heart of our work. The answers to these questions can establish very broad and far-reaching policies that could have a significant effect on the way FDA regulates many different drugs.

In fact, the answers to these questions could establish pathways that could make many more products available as over-the-counter drugs.

That could be a positive public health step, and one that I would support as the agency’s Commissioner if it means we could safely make many more effective medicines more easily available.

We believe these novel regulatory issues should be considered in an open, public process.

Rather than answering these questions in the context of a decision on a single drug, we need to have an open process to solicit public comment.

These regulatory and policy questions are too profound and cut across too many different products to be made behind closed doors.

And so today we are also announcing that we are taking the action of publishing an advance notice of proposed rulemaking to initiate an open public process to consider these important regulatory and policy questions.

Not acting in the best interests of the public.

Not acting in response to scientific evidence.

And America's children and young women will suffer at the hands of these theocrats who refer to the Bible first and America's scientists and experts only as an afterthought.

As reported by the Union of Concerned Scientists on the question of the youngest members of our society who have the greatest need for prevention of pregnancy:
Advisory committee members also underscored the importance of making recommendations based on a risk-benefit analysis, particularly with regard to young people. Pediatrician Dr. Leslie Clapp from Buffalo, New York, spoke about her own clinical practice and acknowledged that, while abstinence is the best option for teens, "[I]f you are a sexually active teen…or eleven year old, it's certainly a bad situation…I think their families and they would have far preferred this option than pregnancy, and it would have been safer."35 Dr. Abby Berenson, a gynecologist from Galveston, Texas, who treats adolescents, echoed the sentiment, arguing further that, "Barriers to use," such as a prescription requirement for Plan B, "will ultimately…result in unintended pregnancies,"36 which pose disproportionate health risks to adolescent women, including premature labor, anemia, and high blood pressure.37
John Kerry has supported the right of American women to a safe and accessible family planning, contraceptives, and "morning after" medication. As reported by on their website:
Actually, this vote had little to do with "parents' knowledge," but Kerry did vote in favor of allowing schools to offer emergency contraception to teenagers, something done in relatively few places. Experts say that such pills can, in some cases, be given to students without knowledge of parents, though the legislation in question was silent on that point.

Kerry's vote, in 2000, was to kill an amendment proposed by Republican Sen. Jesse Helms of North Carolina to bar the use of federal funds “for the distribution or provision of postcoital emergency contraception” to anyone under age 18 in an elementary or secondary school.
Kerry's effort actually failed but this Helms amendment "later died in a House-Senate conference, and never became law."

America deserves better! We need a President who appoints FDA Administrators who listen to scientists and physicians when deciding on safety and efficacy of medication. We need a President who can distinguish between a morning-after pill and an abortion. A President who is concerned about the health of America's women and not just the salvation of their souls. America needs John Kerry!



Blogger Todd Mitchell said...

Bob, you know what the sad thing is? Bush actually represents a *majority* of our citizens views on this. See today's NYT for more poll numbers re: Creationism v. Evolution. I've got a link over on my blog under "Nawlins".

Talk about depressing.

12:02 PM  
Anonymous Blue Cross of California said...

I think Kerry could have provided great health insurance and made a major difference with our health care crisis.

11:49 PM  

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