Seeing Your Doctor for Prevention,
Treating On Your Own: A Report from the Field

First off, let me be clear: what I report below I am not recommending. My first obligation is to my readers. Also, I am grateful to Brooke Binkowski, a stellar journalist-friend, who spontaneously emailed me this story this morning. It arrived in my inbox amid a heated social-media discussion about who the real villains are in the failure to vaccinate. Also, why is it we can’t reach them. Are they the rich and entitled, the libertarians, the natural, organic folk, or who?

Sometimes, you hear a story and it makes you want to use it while it’s hot. This is a gem of a story, but it’s not really about vaccines very much. If you like it, you might want to follow Brooke at @brooklynmarie. She has a lot of great stories up her sleeve.

Here’s what Brooke wrote:

Because of who I am and where I live, I collect old hippies, you know, I feed them, talk to them, hang out with them… one of them stopped by yesterday, he’s about 70, an ex-drug runner, never has taken care of his health, has diabetes, and has had major heart surgery last year (I went to see him in the hospital.)

Anyway I said: “How have you been? He said, “Oh, I’ve been fine. I ran into complications recently, did something to my pinky toe, so I cut it off.” I said, “I’m sorry – you had it cut off?” He said “No, I cut it off myself, just nipped it off with a pair of pliers, wanna see?” (of course I did, I am one of those people)

So he’s showing it to me, it’s healing nicely, etc, and I say to him, well what happened? He said: “I’m diabetic, it was getting gangrenous, just wasn’t feeling it, so… also I decided to go off my heart meds, they were making me feel like crap.” So this guy, the ex-drug runner who cuts off his own toes and now lives out in a boat on the marina. He has a daughter. Guess what?  He got her vaccinated.

Man holds pliers to his toe. This is a likeness,  This toe is healthy and was left alone.

Man holds pliers to his toe. This is a likeness, not the toe or the man in the story.This toe is healthy and was left alone.

Health Disparities and Behavior Change:
A Plea to Stop the Attack Ads

The NYC Department of Health and Mental Hygiene takes on a poor, white, single-mom, smoker in a harsh black-and-white tv spot. An off-camera announcer essentially tells her to quit smoking or risk leaving her children without a parent. That’s the latest spot, viewable in the New York/NJ/Connecticut market. The NYC Department of Health and Mental Hygiene has been running these in-your-face ads that press for healthy behavior change for awhile, but what’s changing is that more places are pushing them as well. Proponents of the ads claim that shock gets people to pay attention and consider changing their ways. I am not addressing the ads that show diseased lungs or people on oxygen here.

I do not like this television spot at all. Yes, it’s eye-catching, but so what? I don’t think it is going to get poor, white, single-mom smokers to quit smoking. Besides, the spot is completely unsympathetic to the woman.

Fighting Smoking, Confronting Poor Single Moms

The television spot opens with a somber male authoritatively stating:

“Mrs. Wadley, I am sorry. You have cancer.” You see an obviously poor white mom who must smoke, facing a harsh light, having trouble focusing. [Perhaps a harsh flash was used.]

The off-camera voice bellows: “What’s worse than finding out you have cancer?” 

The camera shifts to the woman anxiously facing her children. Their backs are to us and in the foreground. Everyone is fidgety: the woman facing her two kids, and her children facing her.

[The answer] “Telling your children that you have cancer,” states the announcer, who we never see.

For a second, the spot flashes on a list of resources to help you quit–thankfully.  Information flashes on and off so fast that any viewer would have to wait for the next spot to copy the information down.

The announcer sounds like a pompous creep and the woman is made to look like a parasite — as if she warrants a push to care for her children and not leave them without a parent.

Disclosure: I never smoked, but I recognize that cigarette smoking causes lung cancer, and that smoking can kill. I’d like to see interventions that work.

Shock Tactics

I don’t know about you, but anyone who has tried to get me to change my lifestyle who attacks me, doesn’t get very far. Many years ago, a doctor made a snide remark about my weight. When I left the doctor’s office, I made a beeline for a hot fudge sundae. I had a neighbor once who was obese, who was bullied by neighborhood kids. As a result, he went on a crash diet, losing lots of weight. He told me that he was so mad that he wanted to show them he could do it. I wonder whether the weight loss was durable: it’s hard to imagine that bullying would lead to healthy behavior change and better health outcomes. If it works, it is not the kind of society that I want to live in.

An ad campaign by Children’s Health in Atlanta, Georgia,  featuring individual fat black and white kids, was yanked recently when the public objected to the strategy. I asked a few people for comment on these photos of 11-year-old children –isolated shots with each of them looking somewhat uncomfortable in their fat selves.

“At first, you look at it and you wonder if it is child abuse,” emailed one person, responding to the photos in the CNN story linked to in the preceding paragraph. She has an obese adult child and continued: “We probably should have started earlier. Now it is too late.” Another emailed me: “The ads are too harsh. If I were an obese child or youth, I would feel humiliated by them.  The ads also have the potential to give fodder to those who bully obese kids.”

An interesting footnote: in Georgia, more positive role models showing kids exercising and eating healthier are now being used to reduce childhood obesity in Georgia.

Another NYC Department of Health spot features an obese black model with a photoshopped, amputated leg to drive home the point that, if you eat supersize portions, you could end up with diabetes and a leg amputation.

Even though subsequent news coverage focused on the identity of the model, whether he knew he was photoshopped, and the ethics of using actors and photoshop, I’d like to see evidence that ads like this really work,  do not cause harm, or worse still, backfire, leading to even more distrust of health authorities.

In the meantime, I have seen another approach: Michelle Obama competing in push-up challenges and potato sack races on television talk shows and on the White House lawn. I’d like to see more concerted efforts to get the poor and minority regular access to healthy, affordable food. I’d like to see more sympathy regarding the barriers to quitting smoking, eating health food, and exercising when you are poor and you have few options.

Admittedly, my litany here is not scientific.

Many people may think whatever it takes to get people to stop smoking, lose weight, and maintain a normal weight, it is worth it. I disagree. I’d like to see the science that backs these kinds of ad campaigns before they are disseminated any more widely. I don’t think that shaming people who smoke or eat too much for their own good is an acceptable strategy. I can’t believe that a stimulus like this is durable either. If ads like this really work and they don’t harm, researchers ought to share the data. But so far, I just hear empty claims – no outcomes data, no follow-up. If people are motivated to quit smoking or adopt a healthier data as a result of the ads, where is the data?

Caveat Emptor: Direct-to-Consumer (DTC) Ads for Testosterone Replacement Therapy Soar

Sebastian Botero in the 2005 Tour de France. By J.P. Partland.

“Ted,” a 50-year-old bicycle racer from Philadelphia, saw his primary care doctor for the last time several months ago– when he was advised to start testosterone replacement therapy. “Your labs are excellent,” said Ted’s doctor. “I’d like to frame them.” The lab values included a normal range testosterone level. Ted was there for a regular check-up and he had no particular complaints, except that he was struggling through the after-effects of a motorcycle accident.

Ted’s doctor told him that even though his testosterone level was normal, with testosterone replacement, Ted might be able to build more muscle mass and go all night. It was not as if Ted indicated he was having any trouble on either of those fronts.

“Nah, that’s okay. I don’t think I need it.” Until this episode, Ted had no real complaints about his doctor and found him pretty knowledgeable. Yet the only pamphlets that Ted saw in his doctor’s office were about testosterone. Ted suspects that his doctor, a solo practitioner, may be trying to hit a volume target:  if his doctor prescribes a certain amount of testosterone replacement therapy, he may get rewarded financially by pharma in what Ted calls a “payola” type arrangement.

While the FDA has cracked down on some promotional activities, it’s still probable that doctors are rewarded for just talking up a product. The placards around the office can open a discussion that might never happen otherwise.

Ted became disgusted when he watched the front office staff ask his doctor what code to put testosterone replacement therapy under for an elderly man seen right before him. “My reaction was ‘the bucket must be pretty big if both of us are candidates for hormone replacement therapy’.”

Ad campaigns on television, newspapers, and the internet urging men age 45 and over to get screened for low testosterone and consider long-term testosterone replacement therapy (TRT) are everywhere. It is hardly surprising: hormone replacement therapy (HRT) for women was a blockbuster drug category long before randomized controlled trials went forward. It was not until the Women’s Health Initiative was stopped early because it showed a link between HRT and both cardiovascular disease and breast cancer that this trend reversed itself. The hypothesis that HRT might help avert dementia did not pan out. That marketing is far from over; journal supplements and continuing medical education programs are devoted to highlighting the limitations  of the  Women’s Health Initiative (for example, claiming that the women were not representative) and maximizing any studies suggesting that even a little hormone replacement therapy given with caution is not so bad after all. Now, as pharmaceutical companies take their turn with men, the marketing is proceeding ahead of rigorous scientific study.

Ads Tackle Aging, Low Libido,  and Low Energy

The ads use macho imagery: cars, computers, and racing prominently. Men look moderately overweight in many ads. Some of the information on testosterone replacement on the web targets men with high cholesterol, diabetes, COPD, and asthma, suggesting that testosterone replacement therapy could reverse low libido, a bummed mood, and low energy in men age 45 and over. The catch-phrase “is it low T” appears in several Abbott ads. Abbott makes the testosterone gel AndroGel and Auxilium the testosterone gel Testim. So far, these are the two products in the US market; more are in the pipeline.

Public opinion on these ad campaigns runs the gamut of people who view it as potentially harmful disease-mongering and medicalization of aging to the point of view that testosterone could confer positive anti-aging benefits.

In June, an event was held in New York City’s Times Square, on what is known as Military Island (a military recruiting station has been there for many years), asserting that men care more about cars than they do about their health.The event featured a young race car driver, a race car, and old vintage cars. Now on the Internet, the ad plainly says it is from Abbott. The Times Square event may have been unbranded. It states that the race car driver had his testosterone checked, that it was fine, and he was relieved. if you maintain a high testosterone, you can still drive fast cars and perform like you did 20 to 40 years ago. (Too bad that the event coincided with the Anthony Weiner twitter fiasco –-hardly the optimal time for a big splash for testosterone therapy.)

One television ad shows a robust man slamming a laptop shut, walking across the screen, with the message: “Stop living life in the shadows.” An ad in the Boston Globe ran a few months back showing a healthy looking man in his forties, reading: “Has he lost that loving feeling? He may have low testosterone (lowT).” Frequently men are shown with their female partners who want the guys upstairs in the sack. The men look distracted and disinterested in sex.

In May,  Pharmaceutical Executive gave Heartbeat and Auxilium Pharmaceuticals (Testim) top billing for “rich media ads that helped dispel common misunderstandings of low testosterone symptoms and increase awareness of the condition and its treatment, while keeping a sense of humor about the potentially sensitive medical issue. The unbranded ads were accompanied by the website and directed users to additional information on symptoms and treatment.

Some low testosterone awareness ads on the Internet that I viewed in May or June had links to the American Diabetes Association (ADA), implying that ADA must espouse the point of view that diabetes is associated with low libido, low energy, and low testosterone; hence, screening for low testosterone in men with diabetes is sensible and safe.  However, such links came up empty—just bringing you to the generic ADA website. This link has since been removed, perhaps because the implication that ADA has guidelines on testosterone screening for men with diabetes is indeed a stretch.

Around the world,  the United States and New Zealand are the  only countries that permit DTC drug marketing, according to Barbara Mintzes, PhD, assistant professor of anesthesiology, pharmacology and therapeutics initiative, University of British Columbia, Vancouver, Canada. If you turn on television during prime time in the US, you are bound to see ads for a multitude of drugs, so much so that it is daunting. In much of the world, DTC drug marketing is illegal. Although DTC drug marketing has been illegal in Canada, the law is not enforced in Canada, Mintzes explains. “This is in part because of the large influence of US media (nearly all Canadians can see US television), and partially because of specific steps that the Canadian government has taken to re-interpret existing laws in a more permissive way,” says Mintzes. Part of this involves the definition of ‘information’ versus ‘advertising,’ another part branded ‘reminder’ ads with no health claims,” said Mintzes. “In both cases Health Canada (federal regulator) has put out advertising policy briefing papers explaining the way the law is being interpreted, and advising industry of what would and would not be considered legal,”stated Mintzes in an email. “It’s a stretch in both cases to connect what’s in those policy papers with the actual words in the law or how it was interpreted previously.”

Canada has a self-regulatory Pharmaceutical Advertising Advisory Board, which can provide opinions on direct-to-consumer ads, and report back to Health Canada. Barbara Mintzes, University of British Columbia. However, as many as 30 percent of Canadians view American television through cable and satellite.

Testosterone Promotional Marketing Questioned

In June, Mintzes and 23 physicians, researchers, and ethicists around the world, including experts at Harvard, Oxford, in Germany, Australia, lodged a formal written complaint with the Pharmaceutical Advertising Advisory Board regarding an ad campaign by Abbott in the June 6 to July 12 Globe and Mail, accompanied by a promotion to physicians, and a Canadian-based website: The ad had been reviewed by PAAB and its logo appeared on the ad, according to Mintzes. The complaint concerns a Canadian ad. It is still pending.

The letter argues: “Not only is the message in this advertisement in contravention of the Food & Drugs Act, it has serious potential to lead to harm to public health, it provides misleading and inaccurate information that would not withstand any serious test of truth in advertising, and it is likely to lead to unjustified increases in health care costs, the latter by promoting testing of men unlikely to be suffering from hypogonadism [the technical term for having a low testosterone]. By redefining this condition to include signs of normal ageing, Abbott is promoting this product for an unapproved use – normal age-related changes in testosterone levels.”

The letter takes issue with promoting testosterone to treat lack of energy, low sex drive, loss of that loving feeling, and urging men to see their doctors for a testosterone test if they experience these things. The low T website also features a 10-question quiz that suggests complaints such as “falling asleep after dinner” or “deteriorating work performance” may be symptomatic of low testosterone.” The email to doctors suggests that 38 percent of men over age 45 could have low testosterone, which the authors contend is inflated.

Also at issue, the authors write, is targeting this to overweight men and those with diabetes, who may be at risk for heart disease. The authors point to a study in the New England Journal of Medicine of testosterone replacement therapy that was halted early because of excess cardiovascular events. (The letter did not address concerns that testosterone is ill-advised in men with prostate cancer or at elevated risk for it, but that has been a concern raised by many physicians.)

The authors of the letter to Canadian authorities also take issue with the “unbranded”campaign, which disguises that it is really from Abbott; this is not in alignment with the WHO Ethical Criteria for Medicinal Drug Promotion, signed onto by all UN Member states. The US ad campaign by Auxilium was similarly unbranded, as was the Times Square/Military Island event.

Testosterone replacement therapy could gain a foothold in markets around the world through aggressive direct to consumer drug advertising and physician incentive programs. Just like hormone replacement therapy for women, it seems to go be going forward with limited science to back broad use.

Later this week: The Science (or lack thereof) to Back Testosterone Replacement Therapy