Tag Archives: FDA

Alzheimers, Imperfect Drugs, and Medical Equity

Debbie says:

In June of 2021, the US Food and Drug Administration (FDA) approved the first drug treatment for Alzheimer’s Disease, a leading cause of dementia in (mostly) older adults. The approval was highly controversial, and resulted in the resignation of three members of the FDA board that voted against approval.  More recently, the Centers for Medicare and Medicaid Services (CMS) chose to make the drug available only for patients in clinical trials, although the FDA approval is not limited. Rachel Sachs, writing at Health Affairs this past January, has a cogent summary of the approval issues and what’s behind them. Basically, the drug has been demonstrated convincingly to reduce plaques in the brains of people with Alzheimer’s but that does not correlate to statistically reliable evidence of actual health improvement.

I had been following this very casually, until I happened to see Isadore Hall’s op-ed piece in my local Black press. Hall feels strongly about the CMS decision:

I know that CMS is fully aware that Alzheimer’s disease is a devastating disease that affects more than 6 million Americans, 80% of whom are Medicare beneficiaries. Among Americans 65 and older, Blacks have the highest percentage of Alzheimer’s disease, 13.8%, according to the Centers of Disease Control and Prevention (CDC). In fact, the Alzheimer’s Association reports that older Blacks are twice as likely to have Alzheimer’s disease than whites.

African Americans are also mostly likely to be undiagnosed for Alzheimer’s Disease, according to the National Institutes of Health. Therefore, we are also most likely to be untreated.

He goes on to explain how personal the issue is for him, as it is for so many millions of people in the United States.

Intellectually, I can understand the CMS decision; in fact, from what little I have in the way of details, it sounds like a scientifically sensible and justifiable decision.

But …

Not everything about this issue is about the science. Having Alzheimer’s in your family is devastating (often more to the family members than the person affected, particularly as the disease progresses). Aduhelm represents hope, even if that hope is tenuous. And the last thing we need as a country right now is a message that says “this particular hope, like so many others, is only available to rich people.” Add in the fact that Black people suffer more from Alzheimers and are vastly less statistically likely to be rich enough to afford it on their own. What’s more, clinical trials (where the drug will be available) are predominantly available to White patients (some estimates put it at 85% of clinical trial patients are White). The FDA is putting together guidance on how to make the trials more equitable–as of this month, that guidance is in draft and not being implemented.

CMS is legally not allowed to consider cost in their decision-making. And it’s no accident that the big insurers have been publicly thrilled with the decision, which gives them cover to refuse to make it available to their customers (of all races).

So, while Aduhelm’s effectiveness and appropriateness is important, so is the availability of hope to all, not to mention even-handed access to resources.

I’m 100% in favor of a better FDA, with a less politicized decision-making process. I would like to see the FDA revisit this approval. Meanwhile, taking this position against the CMS ruling aligns me with some uncomfortable allies, including the Wall Street Journal and many Republican politicians. But in the end I was moved by Isidore Hall. (“My grandmother lost her fight to Alzheimer’s Disease in 2017. I often watched her feeling helpless as she suffered from this horrifying and painful disease.”) I believe this medication should either  be available to everyone or to no one.

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Sex-Linked Links

Debbie says:

Last time I set out to do a links round-up, I wound up with a themed post on penises. This time, I’m finding a set of themed links on human sexuality. One day, we’ll have a real wide-ranging links round-up … but not today.

299px-Sperm-egg

Diane Kelly at Throb shares an interesting insight into why more babies are boys than girls … and why what we’ve always believed about that is wrong.

For nearly two centuries, experts have assumed that the skew came from a higher rate of male conceptions. In an article at Nautilus, David Steinsaltz, J. W. Stubblefield, and J. E. Zuckerman explain that an early, 19th-century guess that more males were conceived to compensate for greater losses in utero–the so-called “fragile male” hypothesis–snowballed into a rarely-questioned “truth. …

In fact, new methods of looking at the sex ratio during development have shown that … X and Y sperm are equally likely to fertilize any given egg. The skew comes instead from differences in survival rates during embryonic development. There’s a complex shift in miscarriage ratios over time, from more males to more females at different moments in gestation. In the end, more female embryos are lost to miscarriage, skewing the birth ratio slightly to males.

I will forbear from making jokes about the “fragile male” hypothesis. Really I will.

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In other news, the FDA has approved Addyi, a libido-enhancing drug for women. This sounds like good news, but Sarah Boseley at The Guardian is viewing it with alarm, and I think she makes sense.

[Cynthia] Graham, [professor in sexual and reproductive health at the University of Southampton] and other critics believe the FDA was pressured and half-shamed into approving Addyi (generic name flibanserin) by a campaign headed by a vocal group called Even the Score, which pitched the absence of drugs to help women with low libido as a gender inequality issue. It describes itself as a campaign for women’s sexual health equality which was “created to serve as a voice for American women who believe that it’s time to level the playing field when it comes to the treatment of women’s sexual dysfunction”. On the front page of its website now runs a banner saying “Thank you, FDA”. Sprout Pharmaceuticals, which owns Addyi, is one of the funders, as is Trimel, another company in the same field.

Nothing makes me more nervous than “grassroots” political groups which turn out to be funded by corporations with a financial interest in their activism. And learning that Addyi is “only moderately effective, should not be taken with alcohol, and has potentially serious side-effects” doesn’t calm my nerves.  I also appreciate the comments by Dr. Petra Boynton, an extremely smart and sensible analyst of sexual issues, who said:

“People have a perception that everybody else is having fantastic sex all the time with exotic positions.” There is, Boynton said, “anxiety brought about by misinformation about sex”, which is perpetuated by the media and especially men’s and women’s magazines. “The cultural wallpaper is telling you that to keep someone and be desirable and not left alone, which is a huge fear, you must be having and providing frequent sex.”

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In a related vein, Mona Chalabi at 538 is talking about “the gender orgasm gap” from her point of view as a data analyst:

In 2009, the National Survey of Sexual Health and Behavior (NSSHB) asked 1,931 U.S. adults ages 18 to 59 about their most recent sexual experience. The topline findings show that men are more likely to orgasm than women — 91 percent of men said they climaxed during their last sexual encounter, compared with 64 percent of women.

But there seems to be a perception gap, too — at least among men. Eighty-five percent of men said their partners in that recent sexual encounter had reached climax, far higher than the percentage of women who said they orgasmed. That can’t simply be explained away by saying that the men were referring to different sexual partners. Most of these sexual encounters were heterosexual — 92 percent of men and 98 percent of women said their last sexual encounter was with someone of the opposite sex. So it seems like some of those men were wrong when they said their partners had orgasmed — either their egos are causing them to overestimate, or some of those women are faking it.

Nothing surprising here (and it’s six-year-old data); nonetheless, 538 is always refreshing because of its focus on data. Chalabi has a lot more to say about which sexual acts, done with whom (including alone), etc.  And who can resist a chart about what acts lead to orgasm entitled “How Come?”

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Finally, Liz Prato at Hippocampus has a rich, nuanced article about female masseuses, male clients, and erections.

Massage school was the first to teach me that there were two types of erections: hostile and benign. My instructors taught me how to deal with each erectile happenstance, ranging from saying nothing at all, to having a clinical discussion with the engorged client about what’s appropriate behavior during a massage. I was confident that, by the time I graduated from massage school, I would have no problems dealing with erections, hostile or otherwise. After all, I’d seen a few in my private life without eliciting trauma, and (thought) I had a clear concept of professional boundaries. This would be no big deal.

My first encounter with a hostile erection popped up a lot sooner than I expected. … My school was a blond brick office building with bleached linoleum floors and industrial-grade carpet (in other words, not a bordello), and my student uniform was khaki pants and a green polo shirt (not a mini skirt and knee-high fuck me boots). My client was in his mid-twenties, with dark hair and a cheesy mustache. The massage began with him lying on his stomach, so if there was an erection, I didn’t see it. Sure, he moaned and groaned a little, but, Hey, some people are expressive, I reasoned. But when he turned over, there it was, pitching a tent under the thin white sheet.

Okay, ignore it, was my tactic. I figured bringing attention to the erection was always the wrong way to go, and just massaged his shoulders. That’s when his moaning turning into loud groaning. “Oh, God, oh, yes! It feels so good!”

Prato goes on to discuss the relationship between massage and sexuality, between touch and sexuality, and the complexities this entails. She looks at the issues with directness and compassion:

I used to have a forty-something client named Tom who saw me weekly. He was referred by a psychotherapist who treats sex addicts. It’s not as creepy as it sounds. I’ve worked with several recovering sex addicts, and they’re no more interested in a Happy Ending than anyone else who lies on my table. These folks have a pretty good idea of where to go for sex and don’t want to waste my time and theirs if that’s what they’re looking for. What they are looking for is touch that’s not a futile attempt to mask their emotional pain. See, for them, sex isn’t about pleasure, and it sure as hell isn’t about intimacy. It’s usually about trying to cover up some horrible wound inside of them, but that’s like trying to douse a flame with kerosene. All it does is create a firestorm of emptiness and shame. When they come to me they want touch that isn’t sexual. They want intimacy with boundaries. They want – and they get – no self-hatred.

When I lay my hands against their skin, it might very well be the first time that touch hasn’t been manipulative or degrading. So they come back. Each time I touch them, they relax a bit more. They feel a little more pleasure. They get a little less scared. It reminds me of how we all walk around carrying fear and self-doubt and weeping wounds, and we’re just doing the best we can to dance around all that pain. I wish I didn’t need to be reminded of that, but I’m so glad I am.

Read the rest; Prato is a fascinating writer.

Thanks to oursin for the Addyi link; the others are from my regular reading