News Contraception

Fourteen Senators Ask Sebelius for Data Justifying Administration’s Decision Denying Teens Access to Plan B

Jodi Jacobson

Today, 14 Senators, 13 Democrats and one independent, wrote HHS Secretary Kathleen Sebelius asking her to provide them with the scientific evidence and rationale for her decision to deny access to Plan B to teens over the counter

See all our coverage of the Administration’s 2011 Emergency Contraception Reversal here.

An error in this article was corrected at 9:17 pm on Tuesday, December 13th.  The earlier version incorrectly stated 14 Democrats signed the letter to Sebelius. The actual tally is 13 Democrats and one Independent, Senator Bernie Sanders from Vermont.

Last week, both President Obama and Secretary of Health and Human Services Kathleen Sebelius overruled the U.S. Food and Drug Administration (FDA) by refusing to allow emergency contraceptives to be sold over the counter (OTC), despite the FDA’s recommendation to do so. They suggested their decision to deny vulnerable teens access to emergency contraception was based on the lack of evidence on whether young teens would understand how to use the method and whether there might be unknown risks.  These statements came despite a wealth of evidence–ten years worth–supporting OTC access to all females of reproductive age, and despite the fact that untold numbers of OTC drugs have far more dangerous potential side effects than any potential adverse effects of Plan B. 

This was poilitics clear and simple. 

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Today, 14 Senators, 13 Democrats and one independent, have written to Sebelius asking her to provide them with the scientific evidence and rationale for her decision.

The letter is as follows:

The Honorable Kathleen Sebelius

US Department of Health and Human Services

200 Independence Avenue, SW Washington, DC 20201

Dear Secretary Sebelius,

We are writing to express our disappointment with your December 7, 2011 decision to block the Food and Drug Administration’s (FDA) recommendation to make Plan B One-Step available over-the-counter. We feel strongly that FDA regulations should be based on science.  We write to you today to ask that you provide us with the rationale for this decision.

As numerous medical societies and patient advocates have argued, improved access to birth control, including emergency contraception, has been proven to reduce unintended pregnancies.  Nearly half of all pregnancies that occur in the United States each year are unintended. Keeping Plan B behind the counter makes it harder for all women to obtain a safe and effective product they may need to prevent an unintended pregnancy.

We ask that you share with us your specific rationale and the scientific data you relied on for the decision to overrule the FDA recommendation. On behalf of the millions of women we represent, we want to be assured that this and future decisions affecting women’s health will be based on medical and scientific evidence.

The letter was signed by Senators Patty Murray (D-WA), Kirsten Gillibrand (D-NY), Barbara Boxer (D-CA), Richard Blumenthal (D-CT), Daniel Akaka (D-HI), Carl Levin (D-MI), John Kerry (D-MA), Tom Harkin (D-IA), Al Franken (D-MN), Frank Lautenberg (D-NJ), Bernie Sanders (I-VT), Ron Wyden (D-OR), Maria Cantwell (D-WA), and Jeff Merkley (D-OR).

Commentary Abortion

Why Is Obama Afraid to Embrace Reproductive Rights?

Erin Matson

On June 14, the White House will host the United State of Women Summit to "celebrate the progress we've made on behalf of women and girls and to talk about how we're taking action moving forward." Yet abortion is nowhere on the agenda.

On June 14, the White House will host the United State of Women Summit to, as its website explains, “celebrate the progress we’ve made on behalf of women and girls and to talk about how we’re taking action moving forward.” Yet reproductive rights are scarcely included.

Six themes are on the agenda: economic empowerment; educational opportunity; violence against women; entrepreneurship and innovation; leadership and civic engagement; and health and wellness—”looking at health coverage, preventative care, pregnancy and more.” Speakers will discuss a number of topics to “inspire all of us to take action on June 14th and well after.” The audience is to be made up of advocates and leaders hand-selected by the White House.

Prenatal care is highlighted in the programming descriptions. Contraceptive coverage is mentioned as part of the Affordable Care Act. Maternal mortality and HIV prevention is discussed as an issue of global health, although these issues remain urgent within the United States as well, with women of color experiencing unconscionable disparities in care. Yet the word “abortion” is nowhere to be found.

This, despite the fact that in the last five years, states put upwards of 288 new abortion restrictions on the books, which is more than a quarter of the total such laws adopted since Roe v. Wade. It’s not stopping. In the first three months of 2016, states introduced 411 new abortion restrictions. The “pro-life” dream is coming true: Clinics are closing, specific methods of abortion are being banned, and those women who take matters into their own hands are starting to trickle into jails under fetal homicide laws that backers swore wouldn’t be used to prosecute women.

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President Obama is well aware of these issues. He knows that Congress has established a select investigative panel for the purpose of harassing Planned Parenthood, even after the sting videos created by David Daleiden to bring the organization down were thoroughly debunked. He knows that the incendiary rhetoric used by the activists and politicians colluding with Daleiden sadly and predictably erupted into a terrorist act, leading to the murder of three people in a Colorado Springs Planned Parenthood health center late last year. He knows that five men and three women in Supreme Court robes are considering Whole Woman’s Health v. Hellerstedt, a challenge to Texas’ abortion clinic closure law and the biggest abortion access case in a generation.

In this environment, there is no acceptable excuse for leaving abortion out of a policy agenda for women. Abortion is an inextricable part of the struggle for women’s equality, and as I’ve covered for Rewire previously, you simply can’t do feminism—a commitment to the social and political equality of all people, especially women and girls—and set the controversy of abortion off to the side.

The strategy of trying to make things better for women by talking about everything but reproductive rights doesn’t work. Hushing up about abortion has not magically ended the domestic violence crisis, produced the votes for paycheck fairness, or mandated paid family leave. Leaving abortion to the side has certainly failed to help women parent their children in safe and healthy communities, free of state or systemic violence.

And yet the current plan for the United State of Women Summit is silence. As a time for women’s advocates to gather and outline strategies for moving forward, abortion should be included, period. Obama has nothing to lose politically by taking a more robust stand on reproductive rights during the sunset days of his administration. In fact, embracing abortion and sexual health for women would serve to strengthen his legacy toward women and girls.

Since that history-making day in 2009 when he took office, Obama has mistakenly treated reproductive rights as playing second fiddle to the women’s movement, and to his broader legacy toward dignity, equality, and justice for all. Yes, Cecile Richards has visited his White House 42 times and yes, public actions such as including the birth control benefit in the health-care law and refusing to allow shutdown-happy Republicans in Congress to defund Planned Parenthood show a level of access, commitment, and support.

But when this president convenes a big table, even a women’s summit, abortion is lucky to get a folding chair in the back. Women who have sex are placed in a silo on purpose.

If we’re honest about it, abortion is controversial because affirming a woman’s inherent right to dignity, power, and sexual pleasure is the controversy. This is about gender roles, sexuality, and control—especially over people born into bodies of color and families without wealth.

Either we believe that women are people and deserve dignity, or we don’t. There is no such thing as equality for women if the precondition of equality is that women shut their legs. Justice doesn’t come with behavioral preconditions targeting the very people experiencing injustice.

An advocate for reproductive health, rights, or justice could, on a level, sympathize with Obama for not wanting to have his presidency and even his legacy-minded women’s summit flanked by bloody fetus posters and buses full of Troy Newmans. But the threat of a sideshow shouldn’t stand in the way of justice. On other issues, this president and his administration have proven capable of growing and changing, as with Obama’s journey to embrace marriage equality. Or, more recently, consider the administration’s clear and firm stance for equality in the face of outrageous discrimination and lies peddled by the right wing, as when it filed suit against North Carolina’s bathroom discrimination law as Attorney General Loretta Lynch told the transgender community, “We see you.”

Not so with reproductive rights. Even the signature accomplishment of the Affordable Care Act—the birth control benefit—was tarnished by new restrictions on abortion funding, and contraceptive coverage exemptions that continue to grow and fail to placate the opposition. President Obama traded away Washington, D.C.’s right to local abortion funding in 2011. His administration attempted to overrule the Food and Drug Administration’s decision to make emergency contraception available over-the-counter without age restriction, an issue that had to be resolved by force of a court order. To date he has failed to take action to correct a ridiculous interpretation of the Helms Amendment, which bars funding in foreign assistance for abortion “as a method of family planning,” and surely was meant to include customary exceptions for rape, incest, and life endangerment. The president has the sole power to fix this—no congressional action required. An executive order on Helms that stands up for rape victims in war zones and women who can’t live through a pregnancy should be a no-brainer.

In any case, this issue can and should be corrected now. Abortion should not be censored out of Obama’s big party for feminism, nor from feminism in general. A webmaster can add reproductive rights to the United State of Women Summit website, and the programming can be updated. President Obama can, for that matter, sign a life-saving executive order on Helms. And his legacy toward women that he cares so much about will be vastly improved.

CORRECTION: This piece has been updated to reflect the correct number of themes on the agenda at the summit.

News Health Systems

HIV Drug Price Increase Brings ‘Price Gouging’ to the Forefront

Martha Kempner

Reports that a drug that treats toxoplasmosis went from $13.50 to $750 per pill caused outrage among medical experts, politicians, and the public.

Pharmaceutical company Turing came under fire last week after the New York Times reported Turing had raised by about 5,000 percent the price of an old drug used to treat an infection that can be life-threatening in those with HIV or AIDS or with otherwise compromised immune systems.

The founder and CEO of the company, Martin Shkreli, initially defended its decision by saying Turing needed to make the drug profitable and planned to use the profits to make a newer, better drug. After being vilified in the press, however, Shkreli said on September 23 that Turing would lower the cost of Daraprim, though he did not say by how much. The controversy gave both medical professionals and politicians an opportunity to discuss the rising prices for drugs that treat myriad conditions.

Daraprim was approved by the Food and Drug Administration (FDA) in 1953 to treat toxoplasmosis, a parasitic infection that can come from eating undercooked meat or unwashed fruits and vegetables. It can also be contracted from cat feces when cleaning litter boxes. The parasite is common and most people never get symptoms, but it can be very dangerous to pregnant women and those with compromised immune systems, such as the elderly, infants, certain cancer patients, and people with HIV or AIDS.

The Centers for Disease Control and Prevention (CDC) estimates that about 4,400 people are hospitalized with the infection and more than 300 die each year. Most people who get sick from toxoplasmosis can be cured with a six-week dose of Daraprim. Those who are immunosuppressed, however, may have to take the drug continually.

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Not long ago, Daraprim cost about $1 per pill. But after GlaxoSmithKline sold the drug in 2010, its price has steadily increased. That year there were about 12,700 outpatient prescriptions for total sales of $667,000. In 2014, however, the number of outpatient prescriptions for the drug dropped to 8,821, but sales of the drug totaled $9.9 million.

There is some disagreement over the exact price of the drug in August when it was sold to Turing. Most reports say it cost about $13.50 per pill, but Shkreli told the Washington Post that each pill was $18 at the time. Either way, the price hike was alarming as Turing began to sell the drug for $750 per pill; an increase of at least 4,000 percent.

This meant that the standard six-week, two-pill-a-day course of treatment went from $1,130 to $63,000. For patients over 132 pounds who have to stay on Daraprim, the drug could cost as much as $634,500 every year.

The medical community called this move unconscionable and pointed out that making the drug so expensive might mean hospitals could not keep it in stock, which would, at the very least, delay treatment for some patients. The Infectious Diseases Society of America and the HIV Medicine Association sent a joint letter to Turing calling the move “unjustifiable for a medically vulnerable patient population” and “unsustainable for the health care system.”

Shkreli defended his company’s price hike saying that the previous manufacturer was practically giving the drug away and that his company couldn’t afford to do that. He argued that the drug is so rarely used that the new price would not impact the health-care system and promised that Turing would put a lot of its profits into researching newer and better drugs to treat toxoplasmosis. He told the Los Angeles Times: “We’re not going to take this money and put it in our pocket or pay ourselves a dividend. We’re not going to stop until we’ve eliminated toxoplasmosis.”

But this rationale was not satisfactory, as research into toxoplasmosis does not appear necessary. Dr. Carlos del Rio, an HIV and AIDS specialist at Emory University, told NBC News: “This is a drug that has no major side effects … it’s usually very well tolerated. It’s not a patient population that is clamoring for a better drug.”

Politicians got in on the outrage. Democratic Presidential candidate Hillary Clinton called the move “price gouging” and “outrageous” and used the story as a hook for releasing her drug pricing plan. Sen. Bernie Sanders (I-VT), who is also vying to be the Democratic candidate for president, and Rep. Elijah Cummings (D-MD) announced that they were requesting information from Turning on the “astronomical price increase.”

The two have spearheaded congressional investigations into drug prices. “The enormous, overnight price increase for Daraprim is just the latest in a long list of skyrocketing price increases for certain critical medications,” Sanders and Cummings said in a statement. “Americans should not have to live in fear that they will die or go bankrupt because they cannot afford to take the life-saving medication they need.”

There are many other examples of companies raising drug prices for no apparent reason other than bolstering the profit margin.

Doxycycline, a common antibiotic used to treat everything from urinary tract infections and chlamydia to Lyme disease and anthrax exposure, went from $20 a bottle in 2013 to $1,849 in 2014. When Rodelis Therapeutics acquired the rights to manufacture Cycloserine, which treats multidrug-resistant tuberculosis, the cost went from $500 a bottle to $10,800. When Valeant Pharmaceuticals bought two heart medications from Marathon Pharmaceuticals, it raised the price of one by 212 percent and the other by 525 percent. This was particularly startling because Marathon had already quintupled the price of the drugs when it acquired them.

Those price hikes are part of the congressional investigations. Those increases did not, however, capture the public’s attention as much the story of Daraprim. Much of the anger seemed to be directed as Shkreli, a 32-year-old former hedge fund manager, who initially said he would not consider lowering the price and called a journalist who questioned his decision “a moron” on Twitter.

Journalists pointed out that this was not the first time Shkreli drastically raised prices on a medication. His former company, Retrophin, bought the rights to a drug called Thiola, which can prevent or reduce the frequency of kidney stones in some patients who are prone to them. When Retrophin acquired the drug, it raised the price from $1.50 per pill to more than $30, meaning that annual treatment for patients who have to stay on the drug went from $2,700 to $54,750.

Urologist Benjamin Davies of the University of Pittsburgh accused Shkreli of having “grabbed an old drug, made no changes to it at all, and hiked the price exorbitantly.”

Shkreli was ousted from and is currently being sued by Retrophin for unrelated issues.

The public pressure seems to have forced Shkreli to reconsider.

“Yes it is absolutely a reaction—there were mistakes made with respect to helping people understand why we took this action, I think that it makes sense to lower the price in response to the anger that was felt by people,” he told NBC News.