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President Barack Obama's stance on an emergency contraceptive betrays his promised principles of scientific integrity and sets a troubling precedent for political interference in 'inconvenient' science.
In the opening months of his administration, US President Barack Obama gathered scientists in the grand East Room of the White House to promise that things would be different on his watch. The president was there to sign a new memo on scientific integrity that directed agency heads not to meddle in the decisions of their scientific staff.
In his speech, Obama pledged that his ambition was “about letting scientists like those here today do their jobs, free from manipulation or coercion, and listening to what they tell us, even when it's inconvenient — especially when it's inconvenient”.
Yet events earlier this month saw Obama demonstrate a blatant betrayal of these principles, when he defended a decision by Kathleen Sebelius, US secretary of health and human services, to override a drug approval by the Food and Drug Administration (FDA).
What is most infuriating is the casual jettisoning of careful evidence on this contraceptive's safety.
Scientific staff at the drug-regulatory agency, including paediatricians, obstetricians and gynaecologists, reached a key determination earlier this year involving Plan B One-Step (levonorgestrel), a single-dose 'morning-after' contraceptive pill. They concluded that it is safe and effective for girls younger than 17 years of age without the currently required prescription — and that these girls could use it correctly without a physician's help. (Older women can already get the contraceptive over the counter.) The FDA experts came to their decision after conducting the usual extensive review, including a comprehensive survey of the literature and data from the pill's manufacturer, Teva, headquartered in Petah Tikva, Israel. These data included age-specific studies designed specifically to address the agency's standards for non-prescription drugs. The scientific staff concluded that, as FDA commissioner Margaret Hamburg put it earlier this month: “There is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”
So much for science. One day after Sebelius announced that she was overruling the agency and denying over-the-counter access to the morning-after pill to females under 17, Obama, questioned by a reporter, said that he agreed with her decision, and added that, “as the father of two daughters” he lauded the application of “common sense”.
He said: “The reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old go into a drugstore, should be able — alongside bubble gum or batteries — be able to buy a medication that potentially, if not used properly, could end up having an adverse effect. And I think most parents would probably feel the same way.”
Where to start? Never mind that the most powerful man in the world didn't bother to get the basic facts right: the contraceptive, even for non-prescription use, is stored behind the pharmacy counter and not “beside bubble gum and batteries”. And never mind the throwback paternalism implied by elevating his own opinion as “the father of two daughters”. What is most infuriating about Obama's response is the casual jettisoning of careful and convincing evidence on this contraceptive's safety and effectiveness, even for young adolescents, and their ability to comprehend the labelling. (It essentially says: “Take this one pill, now.”) With it went his own promise to the thousands of scientists whose hard work and science he had pledged to respect, “especially when it's inconvenient”. It certainly is inconvenient, on the cusp of an election year, in what is at heart a deeply conservative country, to acknowledge that young adolescents can and do have sex, and that they may not have thought out the potential consequences in advance. So inconvenient, apparently, that the work of the scientists, who spent long hours weighing risks and benefits for the public good, must be thrown under a bus.
Most troubling of all is that Obama has set a precedent for overriding science. Sebelius's trampling of a drug decision by the FDA is the first in living memory. If it is acceptable for her to override the agency for this year's reasons of political convenience — or, for that matter, for reasons of heartfelt belief — what politically loaded drugs will next come under the axe?
If there is a silver lining here, it is that some agencies seem to be listening to what the president says rather than following what he does. Several are working hard to put in place the integrity policies he mandated nearly three years ago (see page 425). The Department of Health and Human Services has not revealed where it stands on crafting such a policy of its own.
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Comments
Commenting on this article is now closed.
Richard Clinnick
Your point is well made re Mr. Obama's promises. However, you also missed the point, one which highly respected scientists have been making for years, just because it can be done doesn't in the least mean it should be done. Remember the atom bomb?
Samer Helal Zaky
Despite the biochemical halo around the argument, I think it has more to do with morals and psychology (also scientifically approached). What do we expect from a teenager who is tempted for sex while securing a "plan B" at hand? I believe this would tremendously boost teenage affairs (highly undesirable at least by (her) parents and not by a crooked society) if not teenage pregnancy themselves. I suggest this survey (availability or not of "planB" to be submitted to the FDA as a reinforcing material? ...and I acknowledge Obama as the father of two daughters rather than the leader of the deluded society.
Grace Cai
I think President Obama did the right thing to overrule the decision. And I wonder if the person who wrote this article is hired by the pharmaceutical company to do so. Without morals, science may be utilized to gain profits or political power.
Robert Olinski
Totally agree with comments by Richard, Sammer and Grace. I think the author needs to ask one question: what is the age of as it is written for these "adolescents to can and do have sex". I think one needs to take a resposibility of their actions while making a life and also not making a sex a casuality among people who at the age of 15 or 17 are on their way to maturity but far from being mature.
Peter Borst
I think that the previous comments miss the essential point. Here is a president who declared support for science, decried the previous administration's willingness to override the findings of scientific experts in order to placate public opinion, and yet is guilty of the exact same thing.
The idea that birth control for teenagers promotes teen sex is nonsense. Teenagers have been making foolish decisions ever since time began, and this would have given them a viable option when faced with a life altering mistake.
Michael Hays
I think some decisions on issues, like this one, transcend science. Science is to be used as a guide in making the final decision. It isn't always, nor should it be, the only factor to be considered. Science did it's job in developing the drug and in validating its safety. The rest is up to us. While the availability of the drug itself may not produce the risky behavior; it may tip the scale under certain social conditions or circumstances. e.g., X tells Y about its availability after Y tells X about his/her potential for interaction with Z. At the very least, in my view, there should be communication between a medical professional and subject Y before a purchase.
M Henri Day
As the commentator points out, these decisions, both that made by Ms Sebelius and its support by Mr Obama, run directly counter to the latter's pledge to let «scientists like those here today do their jobs, free from manipulation or coercion, and listening to what they tell us, even when it's inconvenient ? especially when it's inconvenient». But given the manner in which this US administration has dealt with the rest of its pledges to the that part of the electorate which chose it, no can be surprised. Like its predecessor, the three main slogans the administration follows in practice (rather than rhetoric) seem to be «WAR IS PEACE», «FREEDOM IS SLAVERY», and «IGNORANCE IS STRENGTH»....
Henri
Kenneth Dormuth
The more complete quote from President Obama is, "The truth is that promoting science isn?t just about providing resources?it?s about protecting free and open inquiry, It?s about ensuring that facts and evidence are never twisted or obscured by politics or ideology. It?s about listening to what our scientists have to say, even when it?s inconvenient?especially when it?s inconvenient, because the highest purpose of science is the search for knowledge, truth and a greater understanding of the world around us." The memorandum referred to in the above article says that decisions should be informed by good science, not that scientists always make the decisions, nor that their decisions should not be challenged. The decision makers in this case did listen to the scientists and did not twist or obscure the findings. The President did not invoke political or ideological arguments in supporting the decision, nor did he question the findings of the scientists. In any case, the decision here was properly informed by science and was made by also taking into account other considerations.
Thomas Barends
Whether or not something is approved of by large numbers of scientists is, I think, entirely beside the point. Science can inform politicians, but it does not deal in "right" or "wrong". Once you start to use the natural sciences to pronounce judgements on what is good or bad, you're getting into very murky water indeed. The FDA can (I have no reason to assume otherwise) determine the relative benefits/risks of a certain type of medication, but I am pretty sure there isn't a lab experiment in the world that can tell me anything about the morality of any action at all. We call on our elected governments to make really difficult decisions like those ones (if we're lucky enough to live in a democracy).
CA P
It appears that stating that a leader "betrays his promised principles of scientific integrity" over an FDA ban is quite strong and maybe not representative of the American scientific community.
As a scientist I believe social context is a valid super-ceder of any scientific agency, on the subject of how to actually apply new discoveries to society – anyone disagreeing might have skipped the subjects revolving this centuries climate change issue. Take "Nature Climate Change" as a mere example. For instance, producing Biofuels might be a scientifically proven and 100% valid way to lower CO2/CO emissions and any research should not be hampered. Practically, considering social context (burning of sugar cane plantations, cutting down primary forest, etc) it is actually a terrible way. (see for instance Nature Climate Change 2, 53?57 (2012) doi:10.1038/nclimate1325). This is an example on why the editorial should be careful not to intertwine "inconvenient" science with "inconvenient" social policy. Biofuel research is (at this point) socially "inconvenient" but it is certainly not scientifically "inconvenient" and should be pursued. A Government's job is to decide whether or not socially "inconvenient" policies should be adopted and, ideally, not to taint any research as "inconvenient".
Strictly personally, agreeing with most comments in the current context, I believe Mr. Obama is 100% right. What he of course meant with "alongside bubble gum or batteries" is that Plan B WILL be used as bubble gum or batteries – which for today's teenagers it might aswell. It is much better to have first accessible over-the-counter long-term birth control than to risk, in a social context, having Plan B turning into Plan A – specially in a conservative America. Again this is strictly personal and social scientists should have an expert opinion.
In any case, I understand the frustration of investors. Researchers should, of course, not be frustrated since they have done their discoveries and safety assessments properly. Such discoveries transcend economy and time and await the proper time to do "more" better than worse.
Ben Towse
Those defending this decision are correct that the wider decision of whether to allow adolescents to use emergency contraceptives is a political, ethical one – not purely a scientific one. However, the proper way to make political/ethical decisions for society is honestly through the proper democratic process. That is not what happened here.
It is not the FDA's job to decide what is socially/politically/ethically permissible. Those are questions for the the legislature, the judiciary and (in the US) the constitution. If Obama or Sebelius wanted emergency contraceptives banned for minors, they should have worked to get a law doing that through Congress (for the record, I hope such an effort would fail). But that has not happened. Emergency contraceptives are legal for minors in the US, therefore it is the FDA's job to decide which ones are safe to sell. Not to enact a ban by dishonest means on grounds of safety against the work of their own scientists.
Plagiarized Grad Student
I like how you worded it Kenneth. As a scientist, and with a member with a rare disease, I have supported Obama and Sebelius in putting more controls on insurance companies who use terrible science to determine medical necessity. I struggled with him going against the scientists. You said it real well. He considered what they said. But they put it to a higher purpose. And it's not like anyone is harmed — these under 17 kids can ask their parents to buy it for them if needed.
Now I just need to find a way to publicize all the bad science I've discovered that insurance companies use to deny care.
T Andrews
I have to wonder at all the comments against Plan B for young people. How is Plan B any different than a condom? (except that the female does not need co-operation from the male partner, and it does not protect against STDs).
Both Plan B and condoms are safe and effective ways of preventing pregnancy that require little pre-planning to be used effectively (unlike the Pill). If you're going to ban Plan B for those reasons you should be banning condoms as well.
Preventing pregnancy does not encourage young children to have sex (bad parenting does, take responsibility for your own children as much as you want them to be responsible for themselves), and they will still have to talk to the pharmacist (a medical professional) to obtain it.
Modesta Ndejembi Njau
I am a scientist and I agree with President Obama's and Secretary Sebellius' decision. It is the right thing to do. Just because the science shows that the pill is safe for children, doesn't make it right to make it easily accessible to them.
Igor Mazin
Richard Clinnick said: Your point is well made re Mr. Obama's promises. However, you also missed the point, one which highly respected scientists have been making for years, just because it can be done doesn't in the least mean it should be done. Remember the atom bomb?
Yes, I do. So who said it should not have been made and millions, rather that thousands, of Japanese citizens should have been allowed to die from continuous conventional bombings (like Tokyo firestorm that cost more lives the Hiroshima), and from inevitable hunger in the coming winter, and of thousands of American and Russian troops forced to invade the islands? What about the cold war turning hot, which it could do a few times, without the deterring power of nuclear arsenals?
Things are by far not simple. There is not a single scientific discovery about which we can confidently say that the mankind would have been better without it.
Igor Mazin
As a father of two daughters, I agree with the article. Withholding a medicine from youngsters does not improve their moral attitudes. It is parental and societal upbringing that does. Depriving young girls for an option of preventing their life to go down the drain because of one false step is morally equivalent to cutting off their fingers if they are once found to squander their lunch money.
Deborah Kaska
Congratulations to Nature for their courage to criticize President Obama for his decision to ignore the recommendation of scientists at the FDA. The writer exposed the "inconvenient truth," that a desire for votes will trump honesty every time for a politician calcined within the crucible of Chicago.
maria reyes
I would also like to congratulate Nature for the reasons mentioned by Deborah Kaska above. You can read more for xristougenniatika
Max Johnston
What difference does it make? Just let people do what they want. If they want to just a private jet charter or some morning after pill, so be it.
Richard Clinnick
Your point is well made re Mr. Obama's promises. However, you also missed the point, one which highly respected scientists have been making for years, just because it can be done doesn't in the least mean it should be done. Remember the atom bomb?
Samer Helal Zaky
Despite the biochemical halo around the argument, I think it has more to do with morals and psychology (also scientifically approached). What do we expect from a teenager who is tempted for sex while securing a "plan B" at hand? I believe this would tremendously boost teenage affairs (highly undesirable at least by (her) parents and not by a crooked society) if not teenage pregnancy themselves. I suggest this survey (availability or not of "planB" to be submitted to the FDA as a reinforcing material? ...and I acknowledge Obama as the father of two daughters rather than the leader of the deluded society.
Grace Cai
I think President Obama did the right thing to overrule the decision. And I wonder if the person who wrote this article is hired by the pharmaceutical company to do so. Without morals, science may be utilized to gain profits or political power.
Robert Olinski
Totally agree with comments by Richard, Sammer and Grace. I think the author needs to ask one question: what is the age of as it is written for these "adolescents to can and do have sex". I think one needs to take a resposibility of their actions while making a life and also not making a sex a casuality among people who at the age of 15 or 17 are on their way to maturity but far from being mature.
Peter Borst
I think that the previous comments miss the essential point. Here is a president who declared support for science, decried the previous administration's willingness to override the findings of scientific experts in order to placate public opinion, and yet is guilty of the exact same thing.
The idea that birth control for teenagers promotes teen sex is nonsense. Teenagers have been making foolish decisions ever since time began, and this would have given them a viable option when faced with a life altering mistake.
Michael Hays
I think some decisions on issues, like this one, transcend science. Science is to be used as a guide in making the final decision. It isn't always, nor should it be, the only factor to be considered. Science did it's job in developing the drug and in validating its safety. The rest is up to us. While the availability of the drug itself may not produce the risky behavior; it may tip the scale under certain social conditions or circumstances. e.g., X tells Y about its availability after Y tells X about his/her potential for interaction with Z. At the very least, in my view, there should be communication between a medical professional and subject Y before a purchase.
M Henri Day
As the commentator points out, these decisions, both that made by Ms Sebelius and its support by Mr Obama, run directly counter to the latter's pledge to let «scientists like those here today do their jobs, free from manipulation or coercion, and listening to what they tell us, even when it's inconvenient ? especially when it's inconvenient». But given the manner in which this US administration has dealt with the rest of its pledges to the that part of the electorate which chose it, no can be surprised. Like its predecessor, the three main slogans the administration follows in practice (rather than rhetoric) seem to be «WAR IS PEACE», «FREEDOM IS SLAVERY», and «IGNORANCE IS STRENGTH»....
Henri
Kenneth Dormuth
The more complete quote from President Obama is, "The truth is that promoting science isn?t just about providing resources?it?s about protecting free and open inquiry, It?s about ensuring that facts and evidence are never twisted or obscured by politics or ideology. It?s about listening to what our scientists have to say, even when it?s inconvenient?especially when it?s inconvenient, because the highest purpose of science is the search for knowledge, truth and a greater understanding of the world around us." The memorandum referred to in the above article says that decisions should be informed by good science, not that scientists always make the decisions, nor that their decisions should not be challenged.
The decision makers in this case did listen to the scientists and did not twist or obscure the findings. The President did not invoke political or ideological arguments in supporting the decision, nor did he question the findings of the scientists. In any case, the decision here was properly informed by science and was made by also taking into account other considerations.
Thomas Barends
Whether or not something is approved of by large numbers of scientists is, I think, entirely beside the point. Science can inform politicians, but it does not deal in "right" or "wrong". Once you start to use the natural sciences to pronounce judgements on what is good or bad, you're getting into very murky water indeed.
The FDA can (I have no reason to assume otherwise) determine the relative benefits/risks of a certain type of medication, but I am pretty sure there isn't a lab experiment in the world that can tell me anything about the morality of any action at all. We call on our elected governments to make really difficult decisions like those ones (if we're lucky enough to live in a democracy).
CA P
It appears that stating that a leader "betrays his promised principles of scientific integrity" over an FDA ban is quite strong and maybe not representative of the American scientific community.
As a scientist I believe social context is a valid super-ceder of any scientific agency, on the subject of how to actually apply new discoveries to society – anyone disagreeing might have skipped the subjects revolving this centuries climate change issue. Take "Nature Climate Change" as a mere example. For instance, producing Biofuels might be a scientifically proven and 100% valid way to lower CO2/CO emissions and any research should not be hampered. Practically, considering social context (burning of sugar cane plantations, cutting down primary forest, etc) it is actually a terrible way. (see for instance Nature Climate Change 2, 53?57 (2012) doi:10.1038/nclimate1325). This is an example on why the editorial should be careful not to intertwine "inconvenient" science with "inconvenient" social policy. Biofuel research is (at this point) socially "inconvenient" but it is certainly not scientifically "inconvenient" and should be pursued. A Government's job is to decide whether or not socially "inconvenient" policies should be adopted and, ideally, not to taint any research as "inconvenient".
Strictly personally, agreeing with most comments in the current context, I believe Mr. Obama is 100% right. What he of course meant with "alongside bubble gum or batteries" is that Plan B WILL be used as bubble gum or batteries – which for today's teenagers it might aswell. It is much better to have first accessible over-the-counter long-term birth control than to risk, in a social context, having Plan B turning into Plan A – specially in a conservative America. Again this is strictly personal and social scientists should have an expert opinion.
In any case, I understand the frustration of investors. Researchers should, of course, not be frustrated since they have done their discoveries and safety assessments properly. Such discoveries transcend economy and time and await the proper time to do "more" better than worse.
Ben Towse
Those defending this decision are correct that the wider decision of whether to allow adolescents to use emergency contraceptives is a political, ethical one – not purely a scientific one. However, the proper way to make political/ethical decisions for society is honestly through the proper democratic process. That is not what happened here.
It is not the FDA's job to decide what is socially/politically/ethically permissible. Those are questions for the the legislature, the judiciary and (in the US) the constitution. If Obama or Sebelius wanted emergency contraceptives banned for minors, they should have worked to get a law doing that through Congress (for the record, I hope such an effort would fail). But that has not happened. Emergency contraceptives are legal for minors in the US, therefore it is the FDA's job to decide which ones are safe to sell. Not to enact a ban by dishonest means on grounds of safety against the work of their own scientists.
Plagiarized Grad Student
I like how you worded it Kenneth. As a scientist, and with a member with a rare disease, I have supported Obama and Sebelius in putting more controls on insurance companies who use terrible science to determine medical necessity. I struggled with him going against the scientists. You said it real well. He considered what they said. But they put it to a higher purpose. And it's not like anyone is harmed — these under 17 kids can ask their parents to buy it for them if needed.
Now I just need to find a way to publicize all the bad science I've discovered that insurance companies use to deny care.
T Andrews
I have to wonder at all the comments against Plan B for young people. How is Plan B any different than a condom? (except that the female does not need co-operation from the male partner, and it does not protect against STDs).
Both Plan B and condoms are safe and effective ways of preventing pregnancy that require little pre-planning to be used effectively (unlike the Pill). If you're going to ban Plan B for those reasons you should be banning condoms as well.
Preventing pregnancy does not encourage young children to have sex (bad parenting does, take responsibility for your own children as much as you want them to be responsible for themselves), and they will still have to talk to the pharmacist (a medical professional) to obtain it.
Modesta Ndejembi Njau
I am a scientist and I agree with President Obama's and Secretary Sebellius' decision. It is the right thing to do. Just because the science shows that the pill is safe for children, doesn't make it right to make it easily accessible to them.
Igor Mazin
Richard Clinnick said: Your point is well made re Mr. Obama's promises. However, you also missed the point, one which highly respected scientists have been making for years, just because it can be done doesn't in the least mean it should be done. Remember the atom bomb?
Yes, I do. So who said it should not have been made and millions, rather that thousands, of Japanese citizens should have been allowed to die from continuous conventional bombings (like Tokyo firestorm that cost more lives the Hiroshima), and from inevitable hunger in the coming winter, and of thousands of American and Russian troops forced to invade the islands? What about the cold war turning hot, which it could do a few times, without the deterring power of nuclear arsenals?
Things are by far not simple. There is not a single scientific discovery about which we can confidently say that the mankind would have been better without it.
Igor Mazin
As a father of two daughters, I agree with the article. Withholding a medicine from youngsters does not improve their moral attitudes. It is parental and societal upbringing that does. Depriving young girls for an option of preventing their life to go down the drain because of one false step is morally equivalent to cutting off their fingers if they are once found to squander their lunch money.
Deborah Kaska
Congratulations to Nature for their courage to criticize President Obama for his decision to ignore the recommendation of scientists at the FDA. The writer exposed the "inconvenient truth," that a desire for votes will trump honesty every time for a politician calcined within the crucible of Chicago.
maria reyes
I would also like to congratulate Nature for the reasons mentioned by Deborah Kaska above. You can read more for xristougenniatika
Max Johnston
What difference does it make? Just let people do what they want. If they want to just a private jet charter or some morning after pill, so be it.