Five Things to Know About the Morning-After Pill on Its 20th Anniversary

Medication portion of PREVEN Emergency Contraceptive Kit. Photo: Smithsonian Institution

In 1993, the New York Times Magazine posited that the morning-after pill might be “the best-kept contraceptive secret in America.” Even many doctors had no idea there was a fallback contraceptive that could be used shortly after unprotected sex or cases of rape.

In many ways, the morning-after pill had been right in front of U.S. doctors for decades. In terms of chemical composition, it was not much different from standard birth control, using the same main ingredients — synthetic hormones — in higher doses. Moreover, many of their colleagues in Europe and Asia had already been prescribing morning-after pills for years.


In 1998, years of research and advocacy led to the first FDA-approved morning-after pill.


Here, however, the secret was still largely intact. A 1994 study by the Kaiser Family Foundation revealed that two-thirds of American women had never heard of the morning-after pill or other forms of emergency contraception (EC). Less than 1 percent had ever used them.

There was an information shortfall in large part because there was no contraceptive that was approved by the U.S. Food and Drug Administration (FDA) specifically for emergency use. Some providers worked around that absence by using the chemically similar estrogen and progestin medications that were approved for regular birth control. By upping the dosage, they created a suitable morning-after pill on their own. But drug makers couldn’t label or market those birth-control pills for emergency, post-coital use, since they weren’t FDA-approved for that purpose. It also spelled problems for federally funded clinics. Federal dollars couldn’t pay for an off-label medication hack, a makeshift morning-after pill that wasn’t officially approved. Continue reading

Morning-After Pill Still Strong

June 20 marks the fifth anniversary of the U.S. Food and Drug Administration’s (FDA) approval of over-the-counter Plan B One-Step, a type of “morning-after pill” (itself a type of emergency contraception), without age restrictions. The first morning-after pill was approved by the FDA in 1998, but political backlash prevented easy access to it for more than a decade.

In 2011, the FDA was poised to approve over-the-counter access for Plan B for people 17 and older. The Department of Health and Human Services intervened, raising concerns that young girls might not be able to use the drug safely — even though studies have shown that Plan B is safer than taking an aspirin. The Obama administration, however, claimed that younger people still needed a prescription to ensure they understood the proper use of Plan B.


Access to Plan B gives teenagers another chance to avoid unwanted pregnancy.


The wrangling continued. In early April 2013, a federal district court judge dismissed that claim, stating that the Obama administration’s restrictions were a “politically-motivated effort to avoid riling religious groups and others opposed to making birth control available to girls.” On April 30, the FDA announced that the morning-after pill would be available without prescription to users 15 years of age and older.

The fight to expand over-the-counter access for the morning-after pill wasn’t over. Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, stated that “over-the-counter access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States.” It wasn’t until June 2013 — five short years ago this week — that the FDA approved Plan B One-Step for over-the-counter sale without age restrictions, after the Department of Justice dropped its appeal. In February 2014, certain generic morning-after pills were similarly approved.

Today, let’s celebrate this expanded access to the morning-after pill by reviewing what we need to know about this important form of contraception. Continue reading

STD Awareness: Herpes in the Headlines

Two separate stories about herpes have popped up in recent headlines, and the news isn’t good. A “citizen-scientist” injected an untested herpes treatment live on Facebook, sidestepping preliminary studies on safety and effectiveness. Meanwhile, research into a promising herpes vaccine was shut down as the extent of one scientist’s severe ethics violations came to light. Both stories show that there is a strong demand for ways to prevent, treat, and cure herpes — and both are case studies in the wrong way to bring such therapies to market.


Unscrupulous researchers may take advantage of people with stigmatized infections like herpes.


Herpes is a sexually transmitted virus that can cause “outbreaks” of painful genital sores. Afterward, the virus goes dormant in the nerve cells, hiding from the immune system. In some people, the virus can “wake up” to cause temporary flare-ups of symptoms. Given how common this virus is, a preventive shot could help a lot of couples discuss their herpes status without as much fear of judgment and stigma.

While someday an effective herpes vaccine might be developed, recent headlines have been unfortunate examples of scientific experimentation gone horribly wrong.

Citizen-Scientists Doing it Wrong

On February 4, at a biohacking conference, Aaron Traywick took off his pants in front of an audience and injected his thigh with a syringe containing a never-before-tested herpes treatment — a type of gene therapy, a treatment that alters a patient’s DNA by inserting genes into their cells. Frustrated by the testing that pharmaceutical companies must do, and the regulations they’re saddled with, he thought his startup company could leapfrog over these steps and go straight from the lab to human testing, using himself as a guinea pig. In addition to the alleged herpes “cure” that Traywick injected himself with, his company makes a similar herpes vaccine, which they hope will prevent herpes infections in those who don’t have it. Continue reading

What’s in a Name? Frances Oldham Kelsey and the Power of Skepticism

If Dr. Frances Oldham Kelsey had been named Mary, Helen, or Dorothy, it’s possible that thousands of babies would have died or been born with debilitating birth defects.

In the mid-1930s, after earning a master’s degree in pharmacology in her native Canada, Frances Oldham wrote to Eugene Geiling, a researcher at the University of Chicago, asking to work in his lab and study for a doctorate. Assuming Frances was a man, Dr. Geiling replied with an offer of a scholarship, addressing the letter to “Mr. Oldham.”


Dr. Kelsey upends the stereotype of the government bureaucrat. She saved lives by being a stickler for details.


Reflecting on the incident in an autobiography, she remembered Dr. Geiling as a “very conservative and old-fashioned” man who “did not hold too much with women as scientists.” His assumption that Frances Oldham was male might have played a role in her scholarship and subsequent education, which prepared her for a career that touched every American.

From an Early Victory in Chicago to a New Career in Washington, D.C.

After moving to Chicago, Frances Oldham earned a doctorate in pharmacology in 1938 and a medical degree in 1950. Along the way, she got married, becoming Dr. Frances Oldham Kelsey, and gave birth to two daughters.

Her work in Dr. Geiling’s lab provided early experience in unraveling medical mysteries. In 1937, more than 100 people, including 34 children, died after taking a liquid sulfa drug formulated with an artificial fruit flavor. Dr. Geiling’s team of scientists soon identified the problem: The medicine was composed primarily of antifreeze — along with the active ingredient, coloring, and flavorings. It was sent to market with no testing. Public outrage led to the 1938 passage of the Food, Drug, and Cosmetic Act, which required manufacturers to provide evidence to the FDA that their drugs were safe. Continue reading

STD Awareness: “Sounding the Alarm” Over Another Antibiotic-Resistant STD

In 2012, the New England Journal of Medicine ominously stated, “It’s time to sound the alarm.” What followed was a description of the evolution of gonorrhea to all antibiotics we have used to treat it, including the last ones we had left. They closed the article with a warning: “The threat of untreatable gonorrhea is emerging rapidly.”

This summer, just five years after that alarm bell was sounded, the New England Journal of Medicine’s prediction came true. Reports of untreatable gonorrhea surfaced, shared in a World Health Organization press release: “Data from 77 countries show that antibiotic resistance is making gonorrhoea — a common sexually-transmitted infection — much harder, and sometimes impossible, to treat.”


An STD most people haven’t even heard of is rapidly evolving antibiotic resistance.


So maybe we should listen when a medical journal talks about the need to “sound the alarm.”

Sexually Transmitted Diseases, the medical journal of the American Sexually Transmitted Diseases Association, did just that in an editorial called “Mycoplasma genitalium on the Loose: Time to Sound the Alarm,” which accompanied two studies detailing antibiotic resistance in a little-known STD called mycoplasma genitalium, or MG for short.

“Let me get this straight,” you might be saying. “First you’re telling me there’s an STD called MG, which most people haven’t even heard of, and now you’re telling me I already need to worry about antibiotic resistance?” Continue reading

Some Good News About Three Sexually Transmitted Viruses

Scientists are hard at work finding ways to improve your health!

With so much bad news emblazoned across headlines in every newspaper you look at, the world might seem like a gloomy place. So let’s take one depressing subject — disease — and peel away the sad outer layer to find silver linings of optimism.

When it comes to infections, a lot of us blame one thing: germs, also known as “bugs” — “pathogens” if we’re fancy. Some people might not think of infectious diseases as being that big of a deal — after a round of antibiotics, you’ll be on the mend. Unfortunately, antibiotics only work for bacteria, but a lot of diseases are caused by other types of germs — for which antibiotics are no match. One type of germ is called a virus, and they can’t be cured. Sometimes they can be prevented with vaccines or treated with drugs. For example, the major strains of human papillomavirus (HPV) can be prevented with a vaccine called Gardasil, herpes simplex virus can be suppressed with antiviral drugs, and HIV can be controlled with antiretroviral drugs — but none of these infections can be cured. HPV is usually defeated by the immune system, but herpes and HIV are with you for life.

But it’s not all bad. Around the world, individual scientists have picked their “favorite” viruses and are devoting their lives to finding better prevention strategies, better treatments, and even cures. Let’s check in with some of the latest headlines touting the successes of science.

New Hope for a Herpes Vaccine

A herpes vaccine would be a blockbuster — given how common this sexually transmitted infection is, a preventive shot could help a lot of couples discuss their herpes status without as much fear of judgment and stigma.

Herpes might cause an “outbreak” — unpleasant symptoms that include genital sores — but afterward the virus goes dormant in the nerve cells, hiding from the immune system. In some people, the virus can come out of its dormancy to cause flare-ups of symptoms, but once it’s had its fun it retreats back to the nerve cells.

Earlier this year, media reported on a promising new candidate for a herpes vaccine. Using a completely different strategy than previous, failed herpes vaccines, the researchers behind this breakthrough targeted the part of the virus that allows it to hide from our immune systems. If this vaccine works as hoped, recipients will be able to mount an immune defense when exposed to the virus, blocking it from establishing a permanent home in nerve cells. It might even suppress outbreaks in people who already have herpes. Continue reading

Tom Price, Secretary Against Health and Human Services?

Protesters at Sen. McCain's Tucson office, December 20, 2016.

Protesters at Sen. McCain’s Tucson office, December 20, 2016.

On December 20, I took part in a demonstration opposing changes to Medicare, Medicaid, and the Affordable Care Act (ACA). We gathered outside Sen. John McCain’s Tucson office and told our health care stories. Almost all of us were women, but our stories included issues like the cost of diabetic testing supplies and insulin, the difficulties with employer-provided health plans that don’t allow specialized testing and care outside of their network, the prohibitive cost of medication for chronic conditions like AIDS, and my story of a CT scan (which I could only afford with government assistance) for something unrelated that found my kidney cancer. We were unable to meet with anyone from the office, but the written stories were given to staff and a later meeting was set up.


Tom Price is among those who could do the most harm to the greatest number of Americans.


I begin with this story because Tom Price, Donald Trump’s nominee for secretary of health and human services, doesn’t think the government has any place in our health care system. He fits very well among Mr. Trump’s choices to head government departments and agencies, a group of people who don’t believe in the work of their respective departments: Jeff Sessions for attorney general, who was denied a federal judgeship because of his racist comments and judicial overreach as Alabama’s attorney general; Scott Pruitt, who has sued the Environmental Protection Agency 13 times because he opposes regulations and doesn’t believe in climate science, to head that agency; Betsy DeVos for secretary of education, who has no background in education and has spent millions of dollars lobbying to get money away from public schools; and Rex Tillerson, who worked all his life for Exxon, which had a large deal with Russia put on hold by sanctions imposed after Russia annexed Crimea, as secretary of state, with the ability to lift those sanctions. And that’s just a sample.

Since 2009, Price, an orthopedic surgeon, has been a member of the American Association of Physicians and Surgeons (AAPS), a group whose members sign a “declaration of independence” renouncing payments from third-party payers, whether government or private insurers. Their journal has published articles opposing taxes on cigarettes, linking abortion and breast cancer, doubting whether HIV causes AIDS, and opposing mandatory vaccinations. They oppose regulating medical practice even as far as hospital peer reviews, and are fiercely for free-market medicine. Continue reading