Tag Archives: death

“Instrument of Torture”: The Dalkon Shield Disaster

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This Dalkon Shield is archived at the Dittrick Medical History Center and Museum at Case Western Reserve University. Photo: Jamie Chung

This Dalkon Shield is archived at Case Western Reserve University. Photo: Jamie Chung

These days, IUDs, or intrauterine devices, have stellar reputations as highly effective contraceptives. Along with implants, IUDs can be more effective than permanent sterilization, and their safety record is fantastic. We also have powerful regulations in place to keep dangerous medical devices off the market, and the FTC can keep manufacturers from making false claims in advertising.

But a previous generation of birth-control users might associate IUDs with dangerous pelvic infections and miscarriages. That’s because a single device, called the Dalkon Shield, almost single-handedly destroyed an entire generation’s trust in IUDs. At the time of its debut, there were dozens of IUDs on the market — but the Dalkon Shield unfairly tainted the reputation of all of them. With no FDA or FTC regulations reining in untested devices or false advertising, women in the late 1960s and early 1970s didn’t enjoy the protections that we take for granted today. And it was actually the Dalkon Shield’s string, which was made with a material and by a method that hasn’t been used in IUDs before or since, that made it dangerous.

Today, IUDs are the most popular form of contraception among physicians wishing to avoid pregnancy.

We’ve known about IUDs for more than a century, and have made them out of ebony, ivory, glass, gold, pewter, wood, wool, and even diamond-studded platinum. These days, IUDs release hormones or spermicidal copper ions, but these older devices were simply objects inserted into the uterus that acted as irritants, possibly enlisting the immune system to kill sperm. They were not as effective as modern-day IUDs.

The Dalkon Shield was invented in 1968, was made primarily of plastic, and had “feet” — four or five on each side — to prevent expulsion. In 1970, after being marketed independently, it was sold to family-owned pharmaceutical giant A.H. Robins Company, of Robitussin fame. It was manufactured in the same factory where ChapStick was produced, and retailed for $4.35.

Dr. Hugh J. Davis, the Dalkon Shield’s primary inventor, claimed that users of his device had a 1.1 percent pregnancy rate — but that number was based on a small, methodologically flawed study conducted over eight months. In fact, the Dalkon Shield had a 5.5 percent failure rate over the course of a year. The fact that the Shield didn’t provide high protection against pregnancy was a huge problem, but its design also dramatically increased risk for pregnancy complications. Of the tens of thousands of users who became pregnant while wearing the Dalkon Shield, 60 percent of them had miscarriages. Continue reading →

STD Awareness: Does Gardasil Have Side Effects?

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Teen_GroupIn 2006, a vaccine called Gardasil made its debut. Its ability to protect against two of the most widespread strains of human papillomavirus (HPV) means that it doesn’t just protect against an infectious disease — it protects against cancer, too. A persistent HPV infection can trigger cell changes that could lead to cancers of the mouth, throat, cervix, vulva, anus, or penis. Gardasil also protects against two additional strains of HPV that cause most genital warts.

The most common Gardasil side effects are fainting, dizziness, nausea, headache, fever, and hives, as well as possible pain, redness, or swelling at the injection site.

Cervical cancer is not as common in the developed world as it once was, thanks to an effective screening test. The Pap test catches “precancerous” cell changes, allowing the precancer to be treated before it develops into full-fledged cancer. So, while HPV vaccines have the potential to save hundreds of thousands of lives if they can be distributed in countries without widespread access to Pap testing, they have utility in the United States, too. Gardasil has spurred declines in high-risk HPV infections and genital wart incidence among American girls — which means less “precancer” and all the invasive, possibly expensive or painful, treatments that they entail, and a lot fewer genital warts. What’s not to like about that?

Despite this, a lot of people are curious about Gardasil’s side effects. If you enter a few key search terms into Google, you can easily find all kinds of websites warning you of Gardasil’s alleged dangers. So, you might be wondering: Is Gardasil safe?

What are Gardasil’s side effects?

Despite Gardasil’s relatively recent debut, many studies have already been conducted to evaluate its safety — and research continues so that we can consistently reassess its risks and benefits. So far, the consensus is that Gardasil is safe, with very few side effects. According to the Centers for Disease Control and Prevention, the most common Gardasil side effects are fainting, dizziness, nausea, headache, fever, and hives, as well as possible pain, redness, or swelling at the injection site. These reactions are not considered to be serious, some people don’t experience any of them, and they are only temporary. Continue reading →

Gardasil and Mortality

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womenVaccination is one of public health’s greatest achievements, but today’s sociopolitical climate promotes unfounded fears. In turn, this fear-mongering has led to outbreaks of otherwise rare infectious diseases, such as measles and whooping cough. Human papillomavirus (HPV) vaccines protect against two HPV strains that cause 70 percent of cervical cancers, which itself is the second-most common type of cancer in women worldwide. Immunization has the potential to eliminate these viral strains, which would save lives and reduce health care costs — but, unfortunately, vaccine horror stories are a dime a dozen on the Internet, and HPV vaccines like Gardasil are popular targets for vaccine opponents.

Of 57 million Gardasil doses given in the United States, 40 confirmed deaths have occurred in recipients. However, these deaths were not caused by vaccination.

There are many claims flying around that Gardasil causes serious side effects, including death. However, claims that Gardasil can lead to death aren’t supported by good evidence. Generally speaking, people who make these accusations obtain their information from a publicly accessible database called the Vaccine Adverse Event Reporting System (VAERS), which collects claims of adverse events from anyone — including health care providers, patients, or family members.

What is an adverse event?

Most people don’t realize that the phrase “adverse event” cannot be used interchangeably with the term “side effect.” An adverse event is something that occurs after a vaccination — such as a headache, seizure, depression, or death. It could happen one second after being injected with a vaccine or more than a year afterward. It could be a coincidence, or it might be caused by vaccination. For example, if two weeks after receiving a flu shot I get a headache, I could legitimately claim it is an “adverse event,” even if my headache had nothing to do with the shot. An adverse event is only called a side effect if it is found to have been caused by vaccination.

What is VAERS?

Despite its occasional misrepresentation in print media, social media, and the blogosphere, VAERS is not a source of information about verified side effects — it is a database of adverse events that have been self-reported by the public. Anyone can submit a report to VAERS — heck, I could claim that the flu shot gave me telekinetic powers in addition to that headache, and it would be recorded in the database. That doesn’t mean that you should worry about coming down with a nasty case of telekinesis after getting a flu shot at the corner drug store. Continue reading →

STD Awareness: Will Gonorrhea Be Worse Than AIDS?

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A scanning electron micrograph of a colony of Neisseria gonorrhoeae, the bacteria that cause gonorrhea. Image: Portland State University

If you’ve been reading the news lately, you might have noticed an odd piece of reportage from CNBC, in which a naturopath claimed that antibiotic-resistant gonorrhea “might be a lot worse than AIDS” and might cause cases of sepsis that could kill “in a matter of days.” This quotation, uttered by a single naturopath, was then exaggerated in sources such as the United Kingdom’s Daily Mail, which ran the headline “Doctors warn that antibiotic-resistant strain of gonorrhea could be ‘worse than AIDS.'” In fact, the only person making this claim was one naturopath, not a doctor, and certainly not plural “doctors.”

There’s a lot to unpack here. First is the alarmism in the original CNBC article, and its dependence on an unreliable source. Second is the issue of antibiotic-resistant gonorrhea itself, which is a very serious public health problem. Thirdly, let’s look at the naturopath’s claim, which is that antibiotic-resistant gonorrhea could unleash a plague worse than AIDS and kill its victims in a matter of days.

Claims that antibiotic-resistant gonorrhea will be “worse than AIDS” are greatly exaggerated.

Alan Christianson, the naturopath behind the hyperbolic claims of super-virulent gonorrhea, does not seem to be an actual expert in infectious disease (his website lists “natural endocrinology” and “male menopause” among his specialties), nor is he a medical doctor. The article identifies him as a “doctor of naturopathic medicine,” but what does that mean?

Naturopaths are not medical doctors, and degrees in naturopathic medicine aren’t awarded by institutions accredited by the Association of Medical Colleges, the body that accredits medical schools. Naturopathy is a philosophy that is not generally supported by scientific evidence, but rather is based in “a belief in the healing power of nature,” according to the National Center for Complementary and Alternative Medicine. It was developed in the 1800s and today encompasses many modalities of alternative medicine, including homeopathy and herbalism. For these reasons, it is odd that a journalist quoted a naturopath on the potential of antibiotic-resistant gonorrhea rather than someone more qualified, such as a microbiologist or epidemiologist. Continue reading →