Tag Archives: clinical trials

STD Awareness: Searching for an HIV Vaccine

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Ever since the dawn of the AIDS era, researchers have worked nonstop to develop an HIV vaccine. In 1984, Margaret Heckler of the U.S. Department of Health and Human Services famously (over)promised that a vaccine would be ready for testing in two years. But it’s taken much, much longer. This Saturday, May 18, is HIV Vaccine Awareness Day, a celebration of the patients, community members, and scientists who are hard at work bringing this vaccine into existence.

Only one vaccine — still in the experimental stage — has shown any effectiveness against HIV.

Hiding from the Immune System

Vaccines are inspired by our own bodies’ ability to fight disease. Usually, when our immune system encounters a threat, it takes note of the viral “antigens,” which are like facial features — a button nose, say, or dramatically arched eyebrows — that make it instantly recognizable. It creates “antibodies,” weapons that can target those antigens like guided missiles. Often, the immune system can remember the distinguishing facial features so it’s ready to attack if the enemy ever returns — giving us immunity, possibly for life.

Vaccines take advantage of our natural ability to create these immune memories by exposing our immune systems to antigens without actually exposing us to infectious viruses. Think of it as a “wanted” poster that helps the immune system recognize “bad guys” before it actually sees them on the street, enabling it to attack and destroy them before they cause disease. Continue reading →

STD Awareness: The Good, the Bad, and the Ugly

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Sexually transmitted diseases (STDs) have been with us since the dawn of time — or at least since the dawn of sex. And, as we continue to hone our approach to preventing and treating them, STDs will always grab headlines, whether the news is bad or good.

The Good

Can the HIV epidemic be stopped?

For more than a decade, AIDS, the illness caused by HIV, was seen as a death sentence. It wasn’t until the mid-’90s that antiretroviral drugs kept the virus in check, prolonging lifespans for people with access to these medications and transforming the infection into a chronic disease. Now, those dreaming of an end to HIV are seeing reasons for optimism. No, a cure isn’t in the works — but many researchers believe we can end the epidemic through prevention.

Ending HIV transmission will take money and an efficient health care infrastructure, but we have the tools to do it. It starts with expanding access to HIV testing — an estimated 15 percent of Americans with HIV are unaware of their status. The next step is to ensure that everyone testing positive has access to antiretroviral drugs. When used correctly, these medications keep viral levels so low that the chances of transmission are virtually nonexistent. More recently, medications called PrEP — pre-exposure prophylaxis — enable people without HIV to protect themselves from infection. Condoms, of course, are a time-tested prevention tool. Gathered together, we have a pretty mighty arsenal. Here in the United States, we could stop HIV transmission in its tracks in just a handful of years. Of course, people all around the world will need access to testing and treatment to halt this scourge on a global level. 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 →

The History of the Birth Control Pill, Part 5: Clinical Trials

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Gregory Pincus, Min-Chueh Chang, and John Rock, three scientists employed by Margaret Sanger and Katharine McCormick to develop the birth control pill.

Gregory Pincus, Min-Chueh Chang, and John Rock were hired by Margaret Sanger and Katharine McCormick to develop the birth control pill.

Welcome to the fifth installment of our series chronicling the history of the birth control pill. In the previous installment, Margaret Sanger and Katharine McCormick envisioned and bankrolled the development of the birth control pill. Now it had to be tested in large-scale trials.

John Rock, Gregory Pincus, and Min-Chueh Chang had collaborated in the Pill’s development; now it was time to conduct clinical trials. The first study observed 60 women, some of whom were infertility patients while others were nurses. These small trials involved daily temperature readings, vaginal smears, and urine samples, as well as monthly endometrial biopsies. Although the initial results seemed promising, the sample size was small and few of the subjects complied with the protocol.

The approval of the Pill in 1960 marked a turning point in our history.

More test subjects were needed. At this point, historians’ accounts differ. Elaine Tyler May claims that, unable to locate an acceptable pool of volunteers, the researchers tested the Pill on subjects who could not give their consent, such as psychiatric patients. According to Bernard Asbell, however, Rock was scrupulous when it came to informed consent, despite it not being a legal requirement — or even much of a concept at all at this time in history.

Willing participants notwithstanding, conducting such trials in the United States posed a challenge, due to laws against contraception. So the first large-scale clinical trials were conducted in Puerto Rico in 1956. Puerto Rico was densely populated and there was a high demand for alternatives to permanent sterilization, which was widespread on the island due to funding from a wealthy eugenicist named Clarence Gamble, who advocated sterilization for the world’s poor. The clinical trials in Puerto Rico were conducted by Drs. Edris Rice-Wray and Adaline Sattherthwaite; the brand of birth control pill tested was named Enovid. Volunteers were so easy to come by that some clinics had waiting lists. Continue reading →

Let’s Talk Contraception: What’s the Difference Between Generic and Brand-Name Birth Control?

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Oral contraceptives (birth control pills) have been around for decades, and many are now available as generics. In general, generics cost less than brand-name medications. Despite saving money, some users question whether generic birth control pills are as “good” as brand-name pills. To confuse the situation, new brand-name birth control pills have been developed that specifically claim other benefits in addition to protection from pregnancy, such as treatment of acne. The cost of these brand-name pills is much higher. To understand the generic vs. brand-name debate, it is first important to understand how drugs are developed.

Clinical evidence doesn’t support the idea that generic birth control pills have different failure rates or side effects than their name-brand counterparts.

When a drug is first discovered and developed it goes through a drug review process. This involves many steps: chemistry experiments to discover the active chemical structure of the drug, manufacturing and testing the chemical drug product, inspections of the manufacturing process, and many other developmental studies. Then there are animal studies to check safety and efficacy — and if the drug works without major side effects. Finally, clinical studies are conducted in people; these studies test to assure bioavailability (the amount of time it takes for the body to absorb the drug). These last tests, in animals and people, show bioequivalence. Bioequivalence means the drug must enter the body, be absorbed in the same time frame, and work in the body the same way consistently.

When a new drug is finally approved by the FDA, it has met strict standards regarding its strength, purity, quality, potency, safety, and clinical effectiveness. New drugs are awarded patents for 20 years, but by the time they come to market, much of that time has run out due to all of the testing requirements. Generics are usually less expensive — manufacturers do not need to repeat discovering the drug, nor must they redo animal and human studies to assure the drug is safe and works as intended. The generic companies also do not need to spend as much money on advertising, marketing, and promotion. Continue reading →

Expanding Options for Male Contraception

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Condoms are the only contraceptive device that does double duty in preventing pregnancy and STD transmission. But will men’s birth-control options expand?

Many have wondered why there is not a male equivalent to the Pill. The short answer to this question is that the release of one egg is easier to prevent than the flow of millions of sperm. The longer answer to that question includes a litany of failures in the search for such technology. Currently, however, there are some interesting developments in male birth control.

The condom, of course, is the only birth-control method to do double duty in reducing risk for both pregnancy and STD transmission, but many heterosexually active males would like more options than the tried-and-true rubber, and their female partners, despite having expanded contraceptive options — including the Pill, the patch, and the IUD — might prefer for the men in their lives to help shoulder the birth-control burden.

One method under investigation is ultrasound, a technology that has been around for quite some time. Though scientists have been aware of its contraceptive potential since at least the 1970s, most studies have been conducted on nonhuman animals (though human trials could be on the horizon). Ultrasound involves the application of high-frequency sound waves to animal tissue, which can absorb the sound waves’ energy as heat. The possibility for ultrasound’s use for contraception operates on the idea that briefly heating the testes, which in mammals are normally kept a few degrees below core body temperature, can halt sperm production, leading to temporary infertility for about six months. Additionally, ultrasound could affect cells’ absorption rates of ions, which itself could create an environment unfavorable to spermatogenesis. Its extremely localized effects on animal tissues make ultrasound an attractive candidate for research.

One small study conducted on five dogs applied ultrasound to the canine testicles three times over a period of a few days. The researchers compared sperm count before the procedure to two weeks after the procedure. After the ultrasound treatments none of the canine sperm samples contained sperm. Side effects included tender testicles that had been reduced in volume. Continue reading →

Pro-Choice Book Club: Histories of Oral Contraceptives

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Hormonal birth control has an incredible history that stretches back almost a century, when Margaret Sanger wrote of her dream of a “magic pill” in 1912. In the ensuing decades, scientists were busy piecing together the complex system of the body’s “chemical messengers,” hormones, and when they learned how to synthesize them in the ’40s, Sanger’s dream was but a few steps away from being fulfilled. Three engaging accounts of the Pill’s development — The Pill: A Biography of the Drug That Changed the World by Bernard Asbell (1995), America and the Pill: A History of Promise, Peril, and Liberation by Elaine Tyler May (2010), and Jungle Laboratories: Mexican Peasants, National Projects, and the Making of the Pill by Gabriela Soto Laveaga (2009) — contain some overlap, while offering different perspectives.

Each author tells the inspiring story of Russell Marker, the chemist who first finagled progesterone from a wild-growing Mexican yam. Despite a near lack of support from pharmaceutical companies and the scientific community, he traveled to rural Mexico on a hunch — and ended up co-founding a laboratory that became the world’s top hormone supplier for the next few decades. Before Marker formulated a way to synthesize hormones in abundance, they were derived from slaughterhouse byproducts and were prohibitively expensive. Marker’s experiments enabled further medical research in hormones, and progesterone was soon used not only in oral contraceptives, but as a precursor for other medications such as cortisone.

While Carl Djerassi is often credited as the “father of the Pill,” both Asbell and May tip their hats to Margaret Sanger and Katharine McCormick, the Pill’s “mothers.” These two women also have fascinating biographies. As a nurse in the early twentieth century, Sanger was acquainted with the horrors that arose when women did not have control over their fertility. Many of her patients became infected or even died as the result of illegal or self-induced abortions, which motivated Sanger to become an activist for contraception’s legalization — an avocation that saw her illegally smuggling diaphragms into the country and serving time in jail after opening a family-planning clinic in Brooklyn. Continue reading →