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.
This claim defies common sense as well as scientific research. Plan B is expensive enough–$35 to $50–that it prevents young women from using it multiple times a month. And it’s a single dose pill. It’s easier to incorrectly take Advil. What else does Sebelius want, a chewable? But in case common sense doesn’t do it for you, the research compiled by the FDA should. Two studies, which FDA Commissioner Hamburg described as “designed specifically to address the regulatory standards for nonprescription drugs”, one involving girls 12 to 17 and one involving girls 11 to 16, showed that they teenagers understood the package well enough to take the medication without a doctor’s supervision.
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.
Once the FDA has authorized a medicine, it seldom withdraws its seal of approval. It approved Avastin to treat breast cancer in 2008. But in July, an FDA advisory panel recommended revoking that authorization.
The FDA won’t make a final decision until December, but only in rare cases does it reject the recommendations of its advisory panel. More than likely, breast cancer sufferers being treated with Avastin, which has been prescribed to some 17,500 patients, will find their lifeline cut off.
The panel concluded that Avastin, which will remain approved to treat other cancers, wasn’t showing enough promise against breast cancer. But we know that in the manufacturer’s crucial phase III trial, nearly 50 percent of patients receiving the medicine saw their tumors shrink — and that Avastin has added years of life for some patients.
a more balanced assessment
http://www.bizjournals.com/sanfrancisco/ blog/2010/10/cancer-network-favors-avast in—mostly.html
Let cancer patients have this pill
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.
The panel concluded that the costly drug doesn’t eke out enough extra lifetime among breast cancer patients to justify its use and risks. This ignores all the “super responders” — the patients who reap significant benefits from Avastin. Scientists have no way of identifying these people in advance, and they could be devastated if they are denied the medicine.
“This is not a worthless drug by any means,” Eric Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston. “There is almost certainly a group of women who get a big benefit.”
Indeed, the Susan G. Komen for the Cure and Ovarian Cancer National Alliance – recently sent a joint letter to the FDA urging the government to keep it as a choice best made by a woman and her doctor.
Hmmm…maybe if men had a higher incidence of breast cancer.
Don’t demonize drug samples. They are crucial to our healthcare
The 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.
As a result, doctors often rely on samples that the pharmaceutical companies give them so they can determine more quickly if a particular drug is right for that patient. That is good and timely medicine. And every drug the companies give away has gone through years of testing with the Food and Drug Administration to make sure it is safe.
Yet under the new healthcare overhaul law, pharmaceutical firms are required to provide Congress with detailed reports on all of the free drug samples they provide to physicians. Some lawmakers see this requirement as a step toward an outright ban on free samples, making it more difficult for doctors to customize drug treatments for their patients.
But samples serve a crucial clinical role. They allow doctors to learn more about the drug to see how well it works. Also, patients are more likely to start treatment if they walk out the door of their doctor’s office with the medicine they need.
Across the country doctors have testified that samples help them improve patient care. Anand Mehendal, a neurologist in Kerrville, Texas, recently said that he uses samples “to see whether the patient is going to tolerate the drug.” Similarly, the American Medical Association has stated that “samples of prescription drug products represent valuable benefits to the patients.”
As a public mental health social worker for my locality I completely agree with this. The unintended consequences of reporting these samples is huge. Look at it this way- many uninsured and under insured patients we see cannot afford their prescriptions so we give them samples. Now the monetary value of these samples are being listed as a “gift” to the prescribing doctor. As a result many doctors are refusing to give them out in fear of tarnishing their good name. As a further result those patients who relied on samples must now either pay high out of pocket costs, switch to a cheaper and less effective medication, or go without. In the mental health world when a patient goes without that often means they end up in the hospital or even worse- the correctional system. So please people, calm down about samples- in the long run they keep costs way down for everyone.
Overweight? No pill will fix that
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.
No question, obesity in this country is epidemic. It is a serious health issue, and there’s a laundry list of consequences for all of us. Heart disease, diabetes, some forms of cancer, high blood pressure and more. Even our kids are too fat, and, as with adults, that has adds social consequences as well. No kid wants to be the fattest child in the schoolyard, no adult wants to ask for the seat bealt extension on an aircraft. And no taxpayer wants to give you Medicare or Medicaid payments to help you with those diseases when you could have avoided them.
Just look around in any public place. A crowded street, a city bus, a shopping mall. We’re huge.
Sickness and death are no way to regulate food
– 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.
Former FDA Deputy Commissioner William Hubbard, now of the Alliance for a Stronger FDA, testified before the Senate Committee on Agriculture earlier this month that the FDA’s responsibilities have grown as its resources have diminished. In the 1970s the FDA performed 35,000 inspections a year, with 70,000 food processing plants subject to regulation. Today, the FDA conducts only 7,000 inspections a year, yet the number of plants has grown to 150,000.
Inspection of imported food is worse. The FDA inspects only a fraction of one percent of the 216,000 foreign facilities exporting food into America.
What can be done? The FDA could persuade Congress to give it more authority to mandate, money and staff. Congress has not even granted the FDA permission to block entry of food from foreign firms that refuse to allow overseas inspection by FDA officials. Nor has it allowed the FDA to mandate preventive controls to hinder terrorists, such as locks on tankers carrying juice or trucks parked at rest stops.
If another $500 million were allocated to inspections, then spending on food would once more equal half the FDA’s budget, the same as it was in the 1970s. American taxpayers and consumers would gain by avoiding illness, thereby increasing productivity at work, school, and home.
Excellent opinion piece. Unfortunately, last week Agriculture Secretary Tom Vilsack told a group of rice growers that the only reason to work on food safety issues in the US is because it will “preserve markets” and “income opportunities.”
http://tinyurl.com/auto78
This is an a-moral position, and frankly terrifying for all Americans.
I guess for Sebelius a pregnant 11 yo is less risky than improperly swallowing two pills. On the other hand, if these girls cannot take pills how can they use condoms; which are sold over the counter. Maybe we should return to the good old days when you had to ask the town pharmacist for any contraception. Change indeed Mr Obama.