Gay patients sometimes excluded from clinical health trials

A portion of the population could have health issues that are being ignored.

There are, unfortunately, many corners of our society that still exclude people who are gay. In most states, gay couples cannot marry; gay people cannot serve openly in the military, and some states even go as far as excluding gays from being able to adopt children. But scientists and doctors are now fearing that another type of exclusion is taking place - one that could have effects on those people’s health and wellness: clinical trials that examine diseases, drugs and medical treatments.

A letter published recently in the New England Journal of Medicine showed that 37 of 243 clinical trials studied that dealt with couples and sexual function barred people who were in same-sex relationships. Researchers at the Fox Chase Cancer Center in Pennsylvania who conducted the study worry that gay patients are routinely excluded from other studies as well, such as ones that study depression [http://www.justmeans.com/Is-Optimism-in-Young-Adults-Harmful-Mental-Health/7945.html] or cancer.

Doctors hoping to create a clinical trial to study a drug often develop a target demographic of people who are a certain age, have a certain disease, or participate in a certain kind of behavior associated with the drug in order to narrow down those who’d be most likely to use, and benefit from, the drug. It’s a vital element to creating a clinical trial. But if doctors, for whatever reason, universally exclude gay participants, then a whole segment of the population will inevitably have health issues that aren’t addressed or uncovered in such trials.

Brian Egleston, Michael J. Hall, and Roland Dunbrack wrote that not all clinical trials use exclusionary language, and that often, gay and lesbian patients might not even be aware that they’re missing out on certain trials:

“To ensure that we did not miss a general pattern of exclusionary language, we also examined eligibility criteria in 1019 studies that we identified by using the search term ‘asthma.’ Exploratory searches indicated that such studies did not have high rates of exclusionary language, and indeed, no asthma trials were found to exclude lesbians and gay men. However, we incidentally found a clinical trial of attention deficit–hyperactivity disorder that required that participants be ‘in a reciprocal relationship with a person of the opposite sex.’

Our results indicate that exclusion of lesbians and gay men from clinical trials in the United States is not uncommon, particularly in studies with sexual function as an end point. It is likely that most gay and lesbian patients are unaware that their sexual orientation is being used as a screening factor for participation in clinical trials. Researchers should be held to careful scientific reasoning when they develop exclusion criteria that are based on sexual orientation.”

Photo credit: Tom Varco

Punishing the overweight into slimness

A recent article I read about opposition to healthcare reform from the “fat pride” movement proved to be a learning moment. And it wasn’t from the story, but my reaction to it. Plus-size advocacy groups, such as the National Association to Advance Fat Acceptance, and the Council on Size and Weight Discrimination oppose proposed provisions that would penalize them for their increased health risks. Responding in part to a societal tendency to view the overweight and obese as being lazy and glutinous, these advocacy groups push the argument that you can be healthy at any size.

To a certain degree the health literature supports this idea: You can be heavier for your height than an ideal body-mass scale would suggest is healthy, but have no increased risk for disease. And there are lots of slender folks with high blood pressure, clogged arteries, and cancers. Smoking, perhaps the single riskiest health behavior, kills the skinny with as much fervor as the large. Beyond a certain size, however, evidence is indisputable: Excess weight increases the risk for conditions varying from arthritis to heart disease, diabetes to cancer.

Initially I responded with scorn: It was the “its all about me” attitude of fringe advocacy groups. I mean, “weight diversity”? “Fat pride”? Give me a break. Then it dawned on me: One of the key proposals of current health reform is the abolishment of pre-existing condition exemptions. Those exemptions currently allow insurers to refuse coverage to people who need it most: These who already have chronic, difficult to manage health conditions. There is relatively little opposition to the abolishment of pre-existing clauses as they apply to bio-medically defined diseases such as cancer or Parkinson’s. So why is being overweight any different? If we agree that it increases disease risk, how is being overweight different from cancer? Even if you argue that the causes of obesity are behavioral rather than genetic, it still pre-disposes you to increased disease risk, plain and simple. And risk factors for many conditions such as cancer and heart disease, which most people are comfortable giving pre-existing condition status, are heavily influenced by behavior.

Perhaps most importantly, lifestyle causes for obesity are socially constructed: Economic incentives to over-produce fattening high fructose corn syrup; mass advertising of nutritionally poor, high calorie fast foods; housing, transportation and workplace trends that discourage exercise; all of these are designed to make us fat. People don’t arrive at fatness by choice, they are led there by following social signs and trends. Finally, punishing people for unhealthy behaviors that are socially promoted may not be the best way to induce healthier choices. It’d be more acceptable to do this with overweight folks than those with cancer, but no less unjust, and no more effective. How does making it more difficult to get healthcare help people improve their health? Would you argue that obesity is a lifestyle choice that warrants punishment? Do you suppose that approach would slim down our epidemic of fatness?

Online drug pushers

Prescription pharmaceuticals are a booming market. In 2008 an estimated $735 billion US was spent globally, with the fastest growth among the merging market places of China, Turkey, Russia, Brazil, Mexico and South Korea. Prescription drugs are important, and contribute greatly to disease reduction and increased quality of life. There is no question that many areas of the planet need greater access to more drugs to improve population health. But it is also increasingly clear that in the more developed areas of the world, prescription drugs are being over used. This is a problem because not only does it waste resources that could be spent on necessary treatment and prevention activities, but they also present health risks.

The pharmaceutical industry portrays itself as an industry motivated by innovation and discovery, and that the research and development costs associated with new drug development warrants the high costs of new products. Unfortunately, in many cases they lack credibility on two fronts: 1. They don’t disclose how much they actually spend on research and development or on marketing, and 2. There is a growing tendency for the largest manufacturers to simply buy the discoveries of smaller innovator biotech companies, reducing Big Pharma to the role of marketer and manufacturer.

Huge strides have been made in the sophistication of drug marketing, with direct-to-consumer (DTC) advertising being among the most controversial. Technically this type of advertising is only legal in the US and New Zealand, but the internet extends the reach of DTC ads to anyone with an internet connection, regardless of prohibitions in their country of residence. Think of any drug name, and add “.com” and you are likely to land on a consumer-focused advertising site that promotes the drug’s virtues. Like any advertising the data presentation is not balanced, and is aimed at selling you a product, not truly educating you about the drug’s merits, dangers, or the condition it is intended to treat.

Traditional advertising is an active process: Marketers intrude their messaging into the magazine, television show, radio station, or subway car where you happen to be, attract your eyes and attention, and deliver a quick, targeted story. The passive online advertising of prescription drugs is different once you venture out of the US market. Pharma needs to deliver two things: Name recognition, and access to information. Companies cannot paste their messages on the sides of busses, so the name recognition is delivered through media stories and product placement in popular culture. Websites provide the access to targeted marketing messages. Certainly not as elegant as a full scale advertising campaign, but likely effective anyway. The genius is that your drug name is being broadcast to customers by sources they truest: A BBC story about swine flu, for example, may mention Tamiflu several times. That’s free advertising for Roche, Tamiflu’s manufacturer. Go to tamiflu.com, and the messaging strategy succeeded.

Is this type of passive marketing unethical? Inevitable? Does it even matter? Let us know what you think!

A little bit of a bad thing (is still a bad thing)

If you have ever wondered what sound a medical organization makes when it loses credibility, or what words best capture the moral failing of a physician selling-out, look no further than the statement by the American Academy of Family Physicians as they partnered with Coca-Cola to “educate” Americans about sugary beverages. AAFP President-elect Lori Heim, M.D., characterizes the partnership as “a way of working with interested companies to develop educational materials to help consumers make informed decisions so they can include the products they love in a balanced diet and healthy lifestyle."

I’m not a food puritan, and I’m not trying to beat up on Coca-Cola. They produce a popular product in high demand around the world. They provide profitable returns to their shareholders, and generally conduct themselves with the propriety expected of the corporate world. But their cola-beverages are not healthy. They never have been healthy. Drink 1 to 2 cans of soda a day and you increase your risk of becoming obese or developing diabetes by about 25%.

This partnership amounts to a shameful nadir in the trend of compromising health advice with the myth that in sufficiently small doses, a bad thing can become good. Or OK. Or at least less bad. Big tobacco tried this with the myth of “light” cigarettes and thankfully failed. It’s not necessary to have every choice you make be a healthy one, but giving the impression that something is healthy when it clearly is not amounts to deception. Being a doctor sponsored to do so by the sugar-beverage industry is conflict of interest.

The problem with this partnership is that it appears to put soda pop into its own nutritional category, with its own “recommended daily allowance” just like any other food. AAFP is essentially conceding that there is an amount that is “healthy” for consumption. But whether you drink one sip or a barrel, coca-cola will never be healthy. Drinking just a little bit doesn’t make it healthy. Just a little probably won’t cause harm, but neither will a sufficiently small amount of the neurotoxin mercury. Think about it. Everything could be considered “OK” in the right amount. Toxicologists say that “the dose makes the poison,” in other words, even a little bit of poison won’t kill you. Conversely too much of anything can be harmful: It’s possible to overdose on vitamin E, and people have died from drinking too much water.

We should all do ourselves the healthy favor of avoiding the “if I eat only a bit of a bad thing, it’ll be OK” mindset. Don’t fool yourself: If something is unhealthy, that’s what it is. Full stop. You can still choose to eat it in moderation, and probably won’t suffer any ill effects. But at least be honest to yourself and understand that some food choices are healthy, others are not. You don’t need a doctor or Coca-Cola to educate you about that.

That’s my rant on the subject. Am I over reacting?

Pandemic con-flu-sion

Public health could learn a lot from Madison Avenue about telling people what to do. Advertising for designer jeans, sports cars or chocolate sells a product and even a life-style with a single image and a couple of words. The same cannot be said for public health communication about the flu.

One simple decision illustrates the confusion: Should my kids get the H1N1 vaccine? Every year my children and I get the flu shot, primarily to avoid transmitting it to those more susceptible to complications. This year the health department says every case of flu currently being experienced is H1N1. Since there is little if any laboratory confirmation, anyone with “flu-like symptoms” is considered infected with H1N1. These include fever, runny nose, muscle aches, and other classic “upper-respiratory” symptoms caused by many viruses, including the common cold. Recommendations call for all school-aged children to receive H1N1 vaccine. But pediatricians were told not to vaccinate anyone 6 or older, since schools have been supplied with vaccine for those kids. So our pediatrician wouldn’t vaccinate my 6-year old son. No problem, he can get it at school right?

Wrong. Last week the school nurse at a local high school officially dispelled a circulating myth that 20% of students had the flu. Unfortunately, the following morning that “myth” ran on the front-page of the local paper. Now those promised doses of vaccine are not being delivered, so schools have begun to cancel or postpone vaccination clinics for children 6 and older.

I’ve suggested earlier that every flu season amounts to a pandemic, but how much worse is H1N1? Its clear that student absences from school are much higher than normal this year. But it’s likely that every kid with the common cold is being diagnosed with swine flu and kept home. On any normal year such kids may have trudged off to school, stuffy nose and all. H1N1’s death toll among school-aged children is close to 90 in the US, higher than we typically see during an entire flu season. But it’s not clear if these children have some risk factor in common that made them especially susceptible. And if it is true that up to 20% of school-aged kids have H1N1, 90 deaths would amount to an exceedingly low death rate.

Despite the media and public health communication frenzy built around the flu this year, no one anticipated the increased demand for regular flu vaccine which has depleted many stockpiles. It will be interesting to see how vaccination rates are affected next year. I anticipate regression to the normal rate, or lower as people decide not to worry about regular flu after surviving the promised plague of H1N1.

Personally I’ve given up on the regular flu shot this year. My doctor has run out, and a flu clinic I was scheduled to attend was canceled. We’ll take our chances with H1N1. How has vaccine communication been in your community: Clear as Madison Avenue or muddy as chocolate?