Opinion

The Great Debate

Plan B: where politics trump science. Again.

By Amanda Marcotte
The views expressed are her own.

Wednesday morning Health and Human Services Secretary Kathleen Sebelius overruled the FDA’s long-awaited decision taking age restrictions off Plan B emergency contraception. The change would have allowed those 16 and under to buy Plan B, moving it from behind the pharmacist counter and into the shelves alongside aspirin and condoms. But now that won’t happen.

The decision confounded the medical community as well as the women’s rights world. Since no HHS Secretary has ever overruled an FDA decision of this sort before, the widespread assumption, best articulated by Matt Langer at Wonkette, was that Sebelius was working under “marching orders from an administration now fully in re-election mode” and fearful of getting a reputation as somehow “soft” on teen sexual activity.

Sebelius admitted to no political calculation, and instead claimed to be concerned about supposedly inadequate research into the effects on 11- and 12-year-olds who might use the pill. FDA Commissioner Margaret Hamburg, no doubt irate at being told she and her entire team don’t know how to do their job as well as non-medical professional Sebelius, denounced this argument, and defended the extensive research done to assure that Plan B was safe for over-the-counter sales. Taking into account the evidence, and the drawn-out political battle over emergency contraception, it’s safe to say that Sebelius did choose political pandering over women and girls’ best interests.

Sebelius was remarkably vague with her concerns about the differences between those under and over 16 years old when it comes to using Plan B. There’s no reason to believe even the youngest girls who access the drug are in any physical danger, which is why groups like the American Academy of Pediatrics support its use for their young patients in need. Emergency contraception is simply a single, high dose of the birth control pill, a drug that girls in the first years of reproductive age (and women far older than them) have been using for decades on a daily basis for contraception and other health reasons. (One formulation of the daily version of the pill, Ortho Tri Cyclen, is even marketed directly to teenagers to control acne.) The most serious common side effect of correctly-taken Plan B is nausea which tends to last for a few hours. (As opposed to the months of nausea that come along with pregnancy.)

The lack of evidence of physical danger to young teenagers taking the pill correctly meant Sebelius was left with mealy-mouthed claims that the dangers to young teenagers were due to the unique inability of girls 11 to 16 to understand the instructions and take the pill properly. She claimed that “there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age,” and then provided no evidence to support the contention that girls 11 to 16 cannot be expected to take the pill correctly.

The government’s waning support of breast cancer?

By Sally Pipes
The opinions expressed are her own.

Breast Cancer Awareness month, which wound down last month, appeared to get plenty of government support.

Health and Human Services Secretary Kathleen Sebelius held a teleconference in recognition of national mammography day. She and Thomas Frieden, director of the Centers for Disease Control, touted a new program to promote awareness. The Vice President’s wife, Dr. Jill Biden, spoke about the importance of early detection, and Barack Obama himself, in a Presidential proclamation, said that “we reaffirm our commitment to supporting breast cancer research.”

It’s a sad irony, then, that at the same moment our leaders say they’re working to fight breast cancer — which kills some 40,000 American women a year — the Food and Drug Administration is on the verge of revoking approval of an important treatment.

Let cancer patients have this pill

CANADA-HEALTH/

One more day — or week, or month, or perhaps even a year. It may not seem like much time, but patients with incurable cancer know better. For Christi Turnage of Mississippi, who lives with stage IV breast cancer, it means seeing her daughter start kindergarten, celebrating her 27th wedding anniversary, and watching her sons graduate from college.

Her family and her oncologist credit her quality of life for the past two years to the drug Avastin, a biologic that combats cancer by cutting off the blood supply to tumors. But advanced breast cancer patients like Turnage have been forced to spend precious time battling something else: the possibility that federal regulators will vote today to remove approval of Avastin for their treatment.

If officials with the U.S. Food and Drug Administration are wise, they will overrule the agency’s cancer-drug advisory panel, which voted 12-to-1 last month to recommend denying a valuable clinical option to advanced breast cancer patients. According to the Department of Health and Human Services, an estimated 40,000 women die from breast cancer each year.

Don’t demonize drug samples. They are crucial to our healthcare

AIDS DEATH RISE DESPITE CALLS FOR TREATMENTThe following is a guest post by Grace-Marie Turner, founder and president of the Galen Institute, a non-profit research organization focusing on patient-centered solutions to health reform.

Medical researchers recently confirmed a link between chronic fatigue syndrome and a recently discovered retrovirus. Armed with this knowledge, some doctors are now prescribing HIV drugs to their sickest patients.

This story highlights how difficult it is for physicians to find the right medicines for their patients. The interaction between a particular drug and the human body is incredibly complex. People react to the exact same treatment in very different ways.

Overweight? No pill will fix that

USA/

The following is a guest post by David Warner, a Philadelphia-based journalist and health writer. The opinions expressed are his own.

Would it not be wonderful if there were a pill for everything?

Have some kind of irritating bug? Pop an antibiotic, even if it’s a virus. Want to quit smoking? The heck with willpower, take something, wear a patch. Sex life on the wane? Men, swallow that little blue pill. Depressed? Can’t sleep? There are so many pills to choose from. Just watch all those late night commercials.

Overweight? There could be a pill for that as well. But you probably won’t be hearing any ad for it real soon. On Thursday, an advisory panel to the U.S. Food and Drug Administration rejected a Vivus’ drug approval bid for their new weight-loss drug called Qnexa, saying it was too experimental because there was not enough data to warrant approval. One FDA panelist said approving it would amount to a “huge public health” experiment. The FDA is expected to issue a final ruling on Qnexa by October 28.

Sickness and death are no way to regulate food

 Diana Furchtgott-Roth– Diana Furchtgott-Roth is a senior fellow at the Hudson Institute and former chief economist at the U.S. Department of Labor. The views expressed are her own. —

The discovery of the salmonella-tainted peanut butter produced and sold by the Peanut Corporation of America at one of its plants, at Blakely, GA, raises a vital question for all Americans.  Does the Food and Drug Administration have the resources to ensure the safety of America’s domestic and imported food supply?

The Agriculture Department does a good job of inspecting animal-based products such as meat, poultry, and dairy, but the remaining part of the food supply that falls under the jurisdiction of the FDA is a different kettle of fish.  The FDA is failing to oversee adequately its share of food and cannot guarantee the safety of foreign food imports.

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