Tag Archives: institutional review board

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 →

The Imaginarium of Doctor Delgado: The Make-Believe Medicine Behind SB 1318

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pillDr. George Delgado, a gynecologist based in San Diego, is probably not likely to win the Nobel Prize in Medicine any time soon — or ever. Delgado’s dubious medical claims have been one of the driving forces behind a piece of legislation, Arizona Senate Bill 1318, that pushes what physician and state Rep. Randall Friese calls “fringe medicine.”

Delgado runs a website called Abortion Pill Reversal, offering 24-hour medical advice to women who have taken the abortion drug mifepristone and regret their decision. “There is an effective process for reversing the abortion pill, called ABORTION PILL REVERSAL, so call today!” the website cheers. Most people have probably never heard that a medication abortion — that is, an abortion performed by administering two pills — can be reversed. If this medical breakthrough sounds new, it’s because it doesn’t exist — at least not within any kind of evidence-based, established medical practice.

So-called abortion reversal is untested for safety or effectiveness.

Unsafe abortions have always been the consequence of the anti-abortion movement. Now unsafe abortion reversals can likely be added to that, thanks to the procedure Delgado has performed and promoted — in spite of scant evidence of its safety and effectiveness. In the two-step process of a medication abortion, a provider first administers a dose of mifepristone and then follows it with a dose of misoprostol. Delgado claims he can intervene in a medication abortion so that the patient’s pregnancy can continue. If patients change their minds after the first step, Delgado claims, they can counteract the initial drug with a dose of progesterone.

For published medical literature, Delgado can claim a 2012 article he co-wrote in the Annals of Pharmacotherapy. The article describes six abortion reversal patients, four of whom, he claims, remained pregnant. Though published in a legitimate medical journal, Delgado’s findings were from a small sample of patients, none of whom were compared in a controlled study to patients who did not undergo the progesterone treatment. Moreover, not everything that’s published in medical journals is well received by the medical community. Dr. David A. Grimes, a physician formerly with the Centers for Disease Control and Prevention, calls the article “an incompletely documented collection of anecdotes.” Continue reading →