Tag Archives: pharmaceutical companies

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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Our Daily Meds

Debbie says:

I finished Our Daily Meds, by Melody Peterson, last week. Sometimes, I think I understand the scope of a social problem, until I read a detailed and well-researched account and realize that what I knew was just the tip of the iceberg. Usually, that’s because I just can’t be cynical enough to take in what’s actually happening.

book cover

This book is a perfect example: Peterson is writing about how the American pharmaceutical industry has intentionally transformed not just the country’s prescription drug habits, but our national health, our attitudes towards our health, and our real income levels.

Basically, Peterson convinced me that it isn’t possible to be cynical enough. Her basic premise is that, while the benefits of prescription medications are obvious and crucial, the concept of marketing them like toys or candy has done an incomprehensible amount of harm. Drug marketing is not only pretty advertisements in public media, it’s also hundreds of millions of dollars spent paying medical doctors and movie stars to convince other medical doctors to prescribe drugs without any scientific evidence for their use–and sometimes with significant scientific evidence that those drugs do harm. It’s taking over the medical journals with articles actually written by the drug companies and their affiliates, lying eloquently about what the drugs do. It’s packaging strong narcotics in berry-flavored lollipops, and writing “children’s books” about how a particular drug transformed an unhappy child’s life.

Peterson details how drug companies have literally (and consciously) invented “diseases,” (such as “overactive bladder”) because they had a drug (in this case for incontinence) that not enough people needed. She has a chapter on Neurontin: an epilepsy drug so ineffective that the FDA approved only as a second drug to supplement some other seizure drug. (Why was the approval so limited? Because it “had not reduced the number of seizures in most volunteers in the company’s clinical trials” and “5 to 10 percent of the epilepsy patients taking [it] actually got worse.”)

The small-time approved use didn’t fit the company’s bottom line. And the law says once a drug has been approved for any single use, doctors can prescribe it “off label” for other uses. So the company decided to sell Neurontin for profitable uses, “from children with attention deficit disorder to adults with sexual dysfunction,” as well as migraines and uncontrolled hiccups. This would be bad enough, if the company had not then gone on to mount a wide-ranging illegal campaign to bribe doctors to prescribe it for these uses … and to pay doctors to convince other doctors to prescribe it. They spent tens of millions of dollars on upscale events at expensive restaurants and country clubs, where paid doctors spoke about nonexistent benefits and drug company salespeople got huge commissions based on number of prescriptions written.

Peterson comes off as a sensible researcher, not a starry-eyed crusader. She never forgets that most of the drugs she is discussing actually do some good. One thing I thought the book might be when I bought it was a deep critique of “brain meds,” but instead she writes about psychoactive drugs as part of the greater pharmaceutical picture, which is much more useful.

She also discusses some hidden social issues: she estimates the number of drug-related deaths in the U.S. at more than 250 per day (!) and shows how these deaths are hidden in the statistics. (I understand that, because anorexia and bulimia deaths are hidden the same way; the cause is “pneumonia” or “heart failure,” and the underlying issues disappear.) She talks about the measurable presence of trace pharmaceuticals in urban water supply (a 2002 study found prescription drugs, fragrances, insect repellents, disinfectants, and other household chemicals in 80% of the streams sampled in 30 states). She discusses the thriving high-school and street-corner market in pretty pills, and the highway and military deaths caused by prescription drug misuse or overuse. She talks about the marketing of drugs to children and the elderly, despite no studies regarding those groups: this results in particular in overprescribing for the elderly, whose body systems often process drugs less efficiently.

I’m a critical reader: I always look for how the author might be slanting her data to make her points. I saw that occasionally in this book, but the vast bulk of the time, Peterson was either giving me statistics on something I already basically believed, or convincing me it was worse than I thought.

Why is this a body image issue? Because body image isn’t just about how we look; it’s also about how we feel. And one of the nastiest aspects of the whole slimy mess is that by promoting sweetness and light, the drug companies have made Americans perceive ourselves as sicker, more in need of help, and less powerful than people anywhere else in the world. (And America’s government and citizens have supported the effort.)

The U.S. is the only country that has let this madness run unchecked. Peterson’s last chapter is a prescription for how to fix this on a personal level and a social level. If your stomach is strong enough, this book is well worth your time.