Tag Archives: Food and Drug Administration

STD Awareness: Winning One War on Cancer

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Cancer starts with the uncontrolled division of cells.

The developed world is in the midst of a huge nosedive in genital warts and cervical “precancer” — all thanks to the human papillomavirus (HPV) vaccine. This simple shot trains the immune system to defend itself against HPV, a virus that causes genital warts and several types of cancer. Most sexually active people will be exposed to it in their lifetimes — it’s even been nicknamed the “common cold” of sexually transmitted infections.

Gardasil 9 protects against seven strains of HPV that collectively cause 90% of cervical cancers and anal cancers, plus the two HPV strains that are jointly responsible for 90% of genital warts. Vaccination also reduces the frequency of “precancers,” which are cellular abnormalities that can be treated before progressing into full-fledged cancer — meaning less time, money, and anxiety spent dealing with follow-up procedures and treatments.

The HPV vaccine is an anti-cancer vaccine.

The vaccine is safe and effective — and when we say “effective,” we mean it could lead to the eradication of HPV, and with it the cancers it causes. A recent analysis of 66 million vaccine recipients published in The Lancet points to plummeting rates of genital warts and precancer. Among teenage girls, there was an 83% drop in HPV-16 and HPV-18 infections (the two strains of HPV that together cause 70% of cervical cancers) — and cervical precancers were cut in half.

The most dramatic gains were made in countries that offered the HPV vaccine to both boys and girls. Additionally, there were even decreases in the HPV strains that aren’t covered by the vaccine — evidence of “cross-protection,” the phenomenon in which the immune system recognizes close relatives of the viruses it has been trained to attack. Even people who did not receive the vaccine were less likely to catch the virus, simply because their risk was reduced if their partners were vaccinated. Continue reading →

STD Awareness: Can Older Adults Receive the HPV Vaccine?

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female-patient-with-female-doctorWhen the human papillomavirus (HPV) vaccines were introduced, a lot of people were excited about protection from a sexually transmitted virus that could cause cancers, including cervical cancer, anal cancer, and head-and-neck cancer. It wasn’t just any old vaccine, it was a shot that could prevent cancer. Cancer!

In fact, a lot of people were disappointed they were too old to take advantage of an anti-cancer vaccine, which was initially approved for people as old as 26. We were given a lot of reasons why people above that age were “too old,” such as the assumption that anyone older than 26 has probably been sexually active for years and would have already contracted the most common strains of HPV.

While getting vaccinated before becoming sexually active is optimal, the HPV vaccine can still benefit people who have already had sex.

But there are compelling reasons to vaccinate people in their late 20s and beyond. In fact, Gardasil 9 was recently approved for people as old as 45. That’s great news for those of us who missed out on the HPV vaccine the first time around. We might never have had any sexual contact, and therefore were never at risk for catching the sexually transmitted virus. We might have found ourselves widowed or divorced after years or decades of monogamy. We might have been sexually active with multiple partners during that time. Whatever our circumstances, those of us who are 45 or younger can now consider HPV vaccination.

HPV and the “Older” Individual

When Cervarix and Gardasil, the first HPV vaccines, were released, they only protected against two cancer-causing HPV strains, HPV-16 and HPV-18, which are responsible for 70 percent of cervical cancers (Gardasil protects against two additional wart-causing HPV strains). A few years ago, Gardasil 9 hit the market, targeting five additional cancer-causing HPV strains — increasing the chances that even sexually active recipients could be protected from HPV strains they hadn’t encountered. Continue reading →

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

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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

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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

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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

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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

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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 →