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.
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.
Extending vaccines to the worlds poorest
–Joe Cerrell is director of Global Health Policy and Advocacy at the Bill & Melinda Gates foundation. He oversees the foundation’s global health communications, public policy, and international finance. The views expressed are his own. –
I recently took my three-year-old twin daughters to their annual doctor visit, where they received their latest round of routine vaccinations. Thanks to the miracle of vaccines, I know my daughters will be protected for life against measles, tetanus, and other diseases that were once serious threats. But incredibly, millions of children in poor countries still die from diseases that could easily be prevented with the effective, affordable vaccines that Americans take for granted.
Fortunately, that is starting to change. This week, a landmark report from the World Health Organization, UNICEF, and the World Bank concludes that a renewed global push on childhood immunization has raised the number of children vaccinated to an all-time high. The authors find that vaccines now save 2.5 million lives worldwide every year.
(Read related Reuters story: Global immunizations hit record but miss millions.)
As we continue expanding access to basic vaccines that have existed for decades, we also need to ensure that new vaccines quickly reach children in need. Typically, when new vaccines are invented, they don’t become available in poor countries until years, or even decades, after being introduced in the U.S. What’s more, effective vaccines don’t yet exist for some of the developing world’s biggest killers, like malaria and HIV.
This situation is a classic case of markets failing the world’s poorest people. Because poor countries have limited ability to pay, vaccine makers have little incentive to make the enormous investments required to develop and manufacture new vaccines for the developing world. So vaccines remain unavailable where they could save the most lives.
Now, innovative thinking on global markets promises to bring long-overdue change.
You speak of money as if it were worthless. It is a measure of worth.
It buys you the food you eat, the clothes you wear, the home you live in, the car you drive, electricity, clean water, health, and all the technology you take for granted.
All of these things are provided to you because you pay for them. If you didn’t pay for them, there would be no reason for anyone to make these things or provide them to you.
And where do you get the money to pay for them? From your work. From some form of contribution you make to the economy (i.e. society) which indicates that you are worth having the food, water, shelter and space to which you are accustomed.
Or alternatively, if you are not worth anything to society, there are enough other people of worth that you can live off the sweat of their brow instead of your own. Thanks to a nation wealthy enough to give government benefits.
The corporations are the reason for the immense wealth of the society in which you live. Whether you choose to give the money you earn to a charitable cause or not is your will. But whether you had a job to earn that money, or an economy to gain that money, or a country where you are wealthy enough to part with that money, is the will of the corporations.
Your definition of competition has no bearing with the actual meaning of the word in biology or society. It is merely your idea of what you think competition ‘should’ be as opposed to what it is.
Competition is the struggle for the lion share of resources, where the strong get the most and the weak get little. Where the group as a whole gain, it is at the expense of those who do without. Where the weak gain charity, it is because the group is rich enough to spare it. Look to animals in nature, or plants, society or economics. It is all the same.
And as for the words of prophets? Nothing you have said has been anything remotely to do with teaching men to fish.
Rather you believe in giving them fish each day, and feeding them for the rest of their lives at the expense of others. And expecting corporations to do the fishing forever, for other people, for free.
You think that the single force driving the economy, profit, should somehow cease to be. This makes as much sense as deciding your car doesn’t need wheels, and still expecting it to drive you somewhere.
We have two choices.
-We can have corporations, poverty and charity.
-Or we can have no corporations, no poverty and no charity.
Why would having no corporations mean no poverty? Because we would all be equally suffering and destitute. Meaning no rich, and hence no poor.
The myth of drug “re-importation”
— Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner. The views expressed are his own. –
On Thursday, as part of the Department of Homeland Security funding bill, the Senate voted to make us less secure by allowing Americans to purchase prescription drugs from Canada over the Internet. The measure is now headed to conference, where House and Senate lawmakers will hammer out a final piece of legislation.
When he introduced the measure to his fellow Senators, Louisiana Republican David Vitter described it as a “re-importation amendment.” And over the next few weeks, as lawmakers deliberate on this, you’re likely to hear that phrase quite a bit. Supporters of foreign drug importation believe that such wording makes this policy more palatable to the American public.
After all, the implication of the term “re-importation” is that once the ban is lifted, U.S. manufacturers will export their drugs to foreign distributors, which will, in turn, sell back those exact same drugs to us.
Brand-name pharmaceuticals found abroad tend to be significantly cheaper than they are in the States, largely because foreign governments impose stringent price controls on most drug sales. Advocates claim that “re-importation” will allow American patients to benefit from this price disparity.
But “re-importation” doesn’t actually describe what will happen if foreign drug importation is legalized. Using the term is an act of linguistic misdirection — or outright chicanery, if you’ve got a cynical streak.
Importing drugs from Canada is exceedingly dangerous for a number of reasons. For starters, many Internet pharmacies based up North are stocked with drugs from the European Union. And while many wouldn’t hesitate to take medicines purchased from countries like France and Great Britain, there’s plenty of risk involved.
This argument takes the debate the wrong direction. The simple truth is that although high drug prices may mean a CEO makes a lot of money, that is but a fraction, far less than 1%, of the what consumers are paying for. So if you say to yourself “It’s OK to “re-import” because it all goes to the CEO anyway”, you are lying to yourself. What is really being bought are the hundreds of thousands of employees working on pharmaceutical development in the U.S. every day.
Our friends that buy their drugs from “Canada” are just freeriding off those that don’t and not paying their share of drug development costs. The result will luckily not mean a lower quality of life because the development has been done already, but future development will lessened. In other fields of medicine, such as hospitals or doctor’s price controls will have a more immediate impact on quality of life.
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.