A Plague of Diseases That Won’t Go Away

I was at least a little alarmed at a report this week that the National Park Service has closed a campground in Yellowstone National Park because of the plague. As you may recall from a class in world history, the plague is spread by insects, usually fleas, and the most common host for these fleas is the nearest available rodent. In this case the culprit appears to be squirrels, so the Park Service is going to spray all the squirrel burrows they can find for fleas.

While the plague may seems like a relic, many diseases that we think of as eradicated are still very much with us. Our CDC puts out a publication called Morbidity and Mortality Weekly Report (MMWR) that tracks 50 or so diseases. Some of them are what you’d expect: flu, tuberculosis, food poisoning, and sexually transmitted diseases. But others seem transported from another place or another time: yellow fever, leprosy (now called Hansen’s disease), and, yes, the plague.

So far this year there have been 2 confirmed cases of plague in the US, after 10 last year. Most cases arise in the mountain West and far West: Nevada, Colorado, California, etc. The last true outbreak of plague in this country was in 1924 in Los Angeles, in which 30 people died. Before that outbreaks had occurred in San Francisco and Oakland that killed more than 100 people.

Making Sense of the Numbers

Here are the MMWR disease tables for the most recent week. When you scan through them, some really interesting (to me, anyway) things pop up. For example:

  • Of the diseases addressed by the MMR and DPT vaccines that create so much controversy, only whooping cough seems to have regained a hold in this country, with more than 19,000 cases last year. In 2014 for mumps the total was under 1,000; for measles 667; and for diphtheria, rubella (German measles), and tetanus combined only 22 cases.
  • Leprosy seems to be holding steady at 80–100 cases a year over the last several years.
  • Tropical diseases are still with us: yellow fever, Q fever, malaria, etc.
  • Only 12 cases of human rabies in 2010 through 2014 combined.
  • Diseases that make the news—think anthrax, ebola, and West Nile virus—come and go. The last confirmed case of anthrax was in 2011, only 6 cases of ebola, and West Nile fell to 414 in 2014 down from nearly 10,000 cases at the peak in 2003.

I don’t think there’s much profound here, but the numbers do help me make sense of what I see in the news.

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Sexual Desire in Women

I admit it, I’m a guy. Not quite a bro, but I have been blessed/afflicted with the Y chromosome. So read what’s here with that in mind.

Yesterday’s post was about the approval of the drug flibanserin, aka “Viagra for women.” From my perspective it doesn’t seem like a good idea, and I laid out my reasoning in that post. Today I want to get into what was behind the FDA’s OK of flibanserin, after two failed attempts at approval.

The Politics of Drug Approval

Flibanserin didn’t all of a sudden get any safer. Three events have changed on the political landscape since the drug was first turned down in 2010.

  • Low libido in women has been medicalized—along with so much else—so now they have a condition that needs to be treated: Hypoactive Sexual Desire Disorder.* (This is close to what used to be called “frigidity” in women, with all its pejorative baggage.)
  • The FDA has placed female sexual dysfunction its list of top 20 unmet needs.
  • An advocacy group has formed around the issue. Even the Score is an association of 26 organizations, ranging from the Red Hot Mamas to the National Association of Clinical Nurse Specialists.

Throwing everything in the basket, the environment was ripe for approval.

Research Into Women’s Sexual Health

The viewpoint of Even the Score is that, since there are now more than 20 prescription treatments for low sexual functioning in men, there should be some for women too. The video on the Even the Score website makes the point. The group blames the difference on indifference to women’s interests. Or maybe on actual antipathy to women’s sexual health—both physical and mental.

Here’s where my being a guy comes in. I want my partner (that’s my wife) to be more interested in sexual relations. Just about anything that will do that gets my support. Put 5 guys together in a room, and they’ll tell you the same thing. Unfortunately, put 35 guys in a room, call them an FDA advisory panel (which used to be all male), and the topic of women’s health in general got pushed to the end of the agenda. As a result, research into almost all areas of women’s health lags behind. Fortunately that’s changing, but there’s still a long way to go to catch up.

So I partly agree and partly disagree that the discrepancy is a result of ignoring a women’s issue. It’s true that we’re still wandering in the weeds of pharmacology when it comes to women’s sexual drive, but it’s pretty much the same for men.

Desire Is a Mystery

The simple fact is that we know very about what triggers sexual desire. The search for Love Potion No. 9 has been going on for millennia. But Spanish fly doesn’t work. Powdered rhino horn doesn’t work. Sorry, not even chocolate works. In some older men, higher levels of testosterone can help. But for most of us, the hunt goes on.

We do have a good idea of what kills libido. Depression, stress, and anxiety will all depress your sex drive. Keep in mind that flibanserin was first developed as an antidepressant. My view is that if you can take care of other aspects of your mental and emotional health, your sex drive will take care of itself.

*At least that’s what it was called at the time the New Drug Application was put together for the FDA. Now, with the release of the updated DSM-5 (Diagnostic and Statistical Manual, the medical Bible for mental and emotional health practitioners), HSDD has been split into male and female versions: Male HSDD and Female Sexual Arousal/Interest Disorder.

Drug Disapproval—Flibanserin

The FDA’s approval of “Viagra for women” was all over the news this morning. Sigh. This is just wrong in so many ways. Let’s dive right in.

First, the characterization is completely off. Viagra treats a physical response, while flibanserin (brand name Addyi; and how do you say that?) treats libido, the mental aspect. The makers of Viagra and other meds for erectile dysfunction (ED) have said that if the desire’s not there, their med won’t help. And flibanserin won’t help with a woman’s physical response to sex.

Second, flibanserin is flat-out dangerous. The FDA had already denied approval twice over safety concerns, primarily nausea, dizziness, and headaches. This might not seem like much, but given the level of benefits the adverse effects were enough to kill the application twice. The makers did more studies, as asked. This time around the dangers were even more severe than first thought—but the benefits were no greater. Still, our FDA said “Yes.”

Just Say “No” to Flibanserin

Flibanserin is intended to treat a newly defined condition called Hypoactive Sexual Desire Disorder—in essence, low libido in premenopausal women. How low is “low”? Your guess is as good as mine. The makers of flibanserin define “low” as in the bottom 10% of desire. With more than 75 million women in the US between the ages of 20 and 54, 10% of that number is a nice population of new “patients.”

But what may seem low to one woman may be just fine for another. Measuring any aspect of mental or emotional functioning is a tricky business to begin with. Even in conditions such as depression and anxiety, which have been studied extensively for decades, assessment tools are notoriously imprecise. In physical conditions, part of a doctor’s job is to determine the cause behind your symptoms. Why is your blood pressure so high? What’s causing those headaches? Leaving treatment of a mental or emotional condition to your MD, though, is just asking for the symptom-treatment approach

The makers have said that they’ll require physicians to undergo training before being able to prescribe the drug, and it will be available only through “certified” pharmacists. I’ve taken some of these online training courses: two pages of text then 10 questions at the end, and voila! you’re certified. The seller has also agreed not to conduct any direct-to-consumer promotions for 18 months. Beginning in month 19, though, watch out for ads that could make your mom blush—and maybe your daughter too.

What’s Wrong About Flibanserin

As I said above, the perils of taking this drug are many and great.

  • Flibanserin tends to make you sleepy, so directions will say to take it before bedtime. There were reports in the trials of auto accidents and falls because women were getting sleepy.
  • Flibanserin makes you sleepy because it messes with your brain chemistry. Flibanserin affects receptors for serotonin and dopamine, and was first developed as an antidepressant. When researchers heard about an increase in libido from some participants, the light bulb went on.
  • Flibanserin doesn’t play nice with alcohol. So not nice, in fact, that there’s a “black-box” warning (the most serious kind) in the prescribing instructions, cautioning users not to consume alcohol while taking the drug. Umm… you want to feel like having sex more often, and no alcohol? How realistic is that for most people?
  • Flibanserin doesn’t play nice with contraceptives either. Typical hormonal contraceptives increase the frequency and severity of adverse effects, without improving the benefits. So have more sex but don’t use the Pill (or any other form of hormonal contraceptive).
  • It’s pink. Really? That’s the best marketing device you could come up with?

By the way, I don’t want to come across here as being against women’s sexuality—or even alarmed by it like some Victorian-era patriarch. I’ll go into that aspect of this drug tomorrow.

PS I came across this little tidbit about flibanserin on Friday. Take it in the spirit it’s offered.

Enjoying the Summer Sun

(Be aware that this post is longer than what you’ll usually see here. There’s just lots to say about the topic.)

I’m just back from a vacation in the Caribbean. (That’s why I’ve been away from this blog.) There’s a tree native to the region called the papelillo. It’s also called the “gringo tree,” because the bark turns red and peels off—just like the skin of gringos who come down and get too much sun too fast. And sure enough, I saw plenty of people who had overdone their sunning and were suffering the effects.

Lots of other people had gone overboard the other way, too—after days in the sun they were just as pasty as when they stepped off the plane. While obviously those who had been burned hadn’t done things right, those who didn’t get any color were wrong, too. I’ll talk about why you need sun in another post. In the meantime, here’s why you do need to be sensible about sun exposure.

The big fear of sun exposure is the development of skin cancer. There’s no question that ultraviolet radiation from the sun can cause changes in skin cells. The most common is a non-cancerous form known as actinic keratosis. This is an area of brown or reddish skin that may feel rough. Over time it can turn into the most common form of skin cancer, squamous cell carcinoma. The next most common form is basal cell carcinoma. These two forms make up more than 90 percent of cases of skin cancer. The third kind is melanoma, considered much more serious. The two types of carcinoma, if left untreated, can eventually grow large enough to be disfiguring—and in rare cases can actually be fatal. The real worry is melanoma, though, because this form has a much greater chance of spreading throughout the body and eventually doing you in.

What’s the Real Story on Sun and Skin Cancer?

More than 30 years ago the Australian health authorities developed a public awareness campaign they called “Slip, Slop, Slap”—Slip on a shirt, Slop on sunscreen, and Slap on a hat. At the time the rate of skin cancer there was alarmingly high—nearly three times that in the US—and climbing. Some studies claimed to show a link between the amount of sun exposure and the risk of developing skin cancer, so it seemed to make sense to reduce exposure to the sun.

In spite of this effort, the net effect on skin cancer in Australia has been minimal. While the rate of the carcinomas has dropped significantly, the incidence of the dangerous melanoma has actually risen by about 60 percent since the beginning of the campaign. Supporters of the campaign point to the first fact as proof of success. But they ignore the second fact, that the number of deaths from skin cancer has been rising steadily.

And the story isn’t any better in this country. The rate of skin carcinomas has been falling, while melanoma is the only one among the more common types of cancer whose rate has been rising—nearly tripling between 1972 and 2006.

With the increased attention to sun exposure, and so much use of sunscreen with higher and higher SPF levels, something’s clearly out of whack. Either sunscreen itself is a problem (I’m not going there, at least not today) or the entire premise of “more sun = increased risk” is wrong.

We’re built to deal with sun exposure just fine. People who spend much of their lives outdoors (farmers, construction workers, etc.) have very low rates of skin cancer compared to the general population. And, curiously, when the more dangerous melanoma form of skin cancer does develop in these people, it tends to appear in areas not exposed to the sun, such as the buttocks and the inner side of the upper arms. So be sensible about your sun exposure—an increased number of bad sunburns in your life increases your risk of developing some form of skin cancer—but don’t worry too much about regular time in the sun.

What to Watch For

You probably already know this, but it’s helpful to include the signs to watch for. The useful mnemonic is ABCDE.

  • Asymmetry—Moles are almost always round or nearly so. If you have a spot that’s irregularly shaped, or that has changed shape, get it checked out.
  • Border—Moles typically have a clearly defined border.
  • Color—Moles are almost always brown or black. If you have something that’s a different color, or more than one color, or that has changed color, that’s a bad sign.
  • Diameter—Moles are most often less than ½ inch (that’s about 1 cm) in diameter. If it’s larger than that, or if it’s been growing, it needs to be looked into.
  • Elevation—Moles are flush with the surface of skin. Anything that’s elevated, especially if it has a rough texture, is worth further inspection. (Sometimes you’ll see the E as standing for “Evolving,” but that’s pretty much taken care of under the other headings.)

The Future Of Prostate Cancer Testing

For years, men “of a certain age” were advised by their doctors to get tested for levels of a compound called PSA (prostate-specific antigen). The theory was that a diseased prostate would produce more of this compound, so by finding men with elevated levels of PSA we could improve early detection of prostate cancer and save lives.

Oh, the holes in this theory.

  • First, levels of PSA rise naturally over time. PSA levels are also naturally higher in African-American men, and in men whose prostate is just larger.
  • Second, elevated levels of PSA could also indicate a benign condition called BPH (benign prostatic hypertrophy–though it may not feel like it’s so benign if you have it).
  • Third, PSA levels don’t distinguish between an aggressive prostate cancer and one that’s growing more slowly.

The American Urological Association predicts that there will be 28,000 deaths from prostate cancer this year. But there’s a big difference between dying “from” prostate cancer and dying “with” prostate cancer. In the AUA’s view, if you died, and you had prostate cancer, you died “from” the disease. And it’s just not so.

Back in 2009 the man who developed a reliable test for PSA, Dr. Thomas Stamey, reversed his position based on the points above, and on the results of a large clinical trial that showed testing for PSA levels made no difference in overall death rates or the death rate from prostate cancer.Add to that the fact that treatment for prostate cancer can leave a man with a “poorer quality of life” (read: impotent), and the rationale for testing goes out the window.

Following that reversal, the US Preventive Services Task Force (not part of the US Government) made final recommendations, giving a D grade to evidence for testing PSA levels. Then in 2013 came revised AUA recommendations for annual PSA testing, which said:

  • Under age 40, no screening;
  • Ages 40-54, no testing for men of average risk;
  • Ages 55-69, regular testing only if you’re at higher risk (say, a family history of prostate cancer); and
  • In men age 70 and up the potential for harm outweighed the benefits, so no testing at all for them.

Now, if you have prostate symptoms, then by all means get tested. Pain or blood on urination, difficulty passing urine, and incomplete emptying of the bladder are all indications that something is going on with your prostate. Even there it’s not the cancer that’s causing problems, though. Instead, it’s that something is causing the prostate to block the passage of urine through the urethra. It could be from a tumor, or from swelling due to BPH. Nevertheless, get checked.

But for you men with ordinary risk levels, and no prostate symptoms, skip the blood test.

The Vaccine Controversy–A Measles Update

The Washington State Health Department announced this week that a women there died after contracting measles. According to the CDC, it’s the first confirmed death in the US due to measles since 2003.

As you can imagine, the press release about this death included a call for more comprehensive vaccination. Public figures, on the other hand, took the opportunity to tweet their opposition to the recent California vaccine legislation, which was signed by Governor Jerry Brown.

In the health department report, the authors say that the woman who died contracted measles while she was in a health care facility. They also say that she already had several other health conditions that compromised her immune system. At no time did she display any symptoms of the disease, such as the characteristic measles rash.

The advice from the Department of Health is confusing, if not contradictory. They say

  1. The patient had a compromised immune system;
  2. People with compromised immune systems often cannot receive vaccinations;
  3. People with compromised immune systems may have poor immune response even when vaccinated; so
  4. You should get vaccinated.

I really don’t understand their logic, if there’s any logic there at all.

The Vaccine Controversy That Won’t Go Away

(Part 1 of 2)
Yesterday (Monday) the California State Senate passed a bill that would require all school-age children to have received a comprehensive vaccination regimen by the time they begin attending school or day care, whether public or private. There would be no exceptions for religious or personal beliefs. Governor Jerry Brown has indicated he will sign the bill.

Opponents of mandatory vaccination say this bill tramples their rights as parents to make healthcare decisions for their children. Supporters point to the Disneyland measles outbreak from earlier this year as evidence that there’s a problem. Most of those infected in the outbreak had not been inoculated, either because they were too young or because their parents had chosen not to provide the vaccine.

The vaccine controversy won’t go away just because of some study or piece of legislation. Much of the opposition comes from a British study published in 1998 that linked early childhood vaccination to autism.

Now, there’s no question that the incidence of autism has been growing alarmingly, and the rise began at roughly the same time as the increase in childhood vaccinations. But Lancet, the journal that published the British study, retracted the vaccine article after investigating further, and a much larger Danish study actually raised the possibility that vaccines protect against autism.

Still, the media picked up on the sensational story. Public figures have said they won’t have their children vaccinated. And now ordinary moms and dads refuse to protect their children. Interestingly, resistance to vaccination tends to be higher among the privileged. Areas of low vaccination rates in California include Silicon Valley, Beverly Hills, and the tonier areas of Orange County.

When I was a lad the MMR (measles/mumps/rubella, or German measles) vaccine hadn’t been developed yet. No surprise, I came down with both types of measles in quick succession. My younger sister developed both types, plus the mumps. My grandmother stayed with our family for nearly a month caring for one or the other of us. Somehow, we survived.

In tomorrow’s post, I’ll talk more about how vaccines work (or don’t) and why the vaccine controversy rumbles on.