Healthy Skepticism Library item: 16222

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Gross J
Hope, With a Deductible
The New York Times 2009 08 05
http://newoldage.blogs.nytimes.com/2009/08/05/hope-with-a-deductible/

Full text:

At a certain hour of the night, the television airwaves are back-to-back-to-back with pharmaceutical advertisements directed at baby boomers.

Us? With erectile dysfunction? Overactive bladders? Brittle bones? Postmenopausal insomnia? Why, just yesterday we were doing the sex-drugs-and-rock-and-roll thing. Surely there’s a fix for what ails us. And so there is, right on the screen: Cialis or Enablex or AmbienCR or Boniva or Crestor or Restasis or FloMax.

Apparently there are even pills and patches to give us back our parents when they are falling down the rabbit hole of Alzheimer’s disease, disappearing before our very eyes. Want a little more time with Mom before confusion and oblivion overtake her? Before she can’t care for herself anymore and no longer knows your name? For that, we have Aricept and four other F.D.A.-approved acetylcholinesterase inhibitors, which increase the level of a chemical messenger in the brain that is involved in memory.

“Don’t wait,’’ urges a television ad for Aricept. “Alzheimer’s isn’t waiting.’’

Nobody seems to know how much of our spending on prescription drugs is inspired directly by what we see on TV. But according to the trade publication Drug Topics, the total retail dollars spent on Aricept was $1.15 billion in 2008. My hunch is that much of it was spent by helpless, heartbroken adult daughters like the one featured in the current three-hanky TV commercial for Aricept.

It makes me cry – and I never even had a parent with dementia. But I know if I had, I’d have been sucked in.

“Every Sunday,’’ the daughter says, “lasagna at Mom’s was a family tradition.’’ She is entering her mother’s house, husband and children in tow. Mom is in the living room, looking frail and addled. The dining room table is bare, and no sauce simmers on the old stove.

“What a nice surprise!’’ the mother says with forced cheerfulness, trying to mask her confusion, as is common in the early stages of dementia when its victims struggle to pass for normal. “Mom, it’s Sunday!’’ the daughter says.

Then comes her moment of epiphany: “That’s when I knew I couldn’t wait.’’

The scene shifts to an outdoor market, where grandmother and granddaughter are choosing the perfect tomatoes. The old woman is bright-eyed, perky, transformed. She could be 10 years younger. Then we see her preparing a meal, sending a linen cloth flaring like a sail over the dining room table. The family gathers for dinner. Lasagna at Mom’s, with her dabbing a bit of sauce from her daughter’s chin, just like it’s always been.

What adult daughter could resist this wouldn’t-it-be-lovely scenario?

Alas, even advocates of the controversial drug are considerably more measured in their assessment of its effectiveness. Eisai Co., Aricept’s manufacturer, and Pfizer, which markets it in the U.S., make modest claims in the prescribing information (PDF). “There is no question we need better therapies,” said Dr. Steve Romano, head of medical affairs for primary care at Pfizer.

Instead of looking for unlikely cures, he said, drug makers are looking for therapies that are more “robust,” whose effects are longer-lasting. “This is a devastating disease to the person going through it, the loved ones and the caregivers,” he added, “and this is the best we have.”

An array of randomized controlled studies, many considered flawed because of their limited duration and high dropout rate, show a slight improvement in cognitive test scores. A study subject might name 11 fruits instead of 10, Dr. Thomas Finucane of Johns Hopkins University told The New York Times’s Denise Grady in a 2004 story, but that doesn’t necessarily translate into improved real-life functioning. What difference does it make if Mom can name 100 fruits when she’s also asking you the same question every five minutes?

And improvement on these tests is seen in only a small percentage of users – 10 to 20 percent, compared to placebo groups, though study results vary – and the effect is usually brief, three to 12 months. Britain’s National Institute for Health and Clinical Excellence (N.I.C.E.), which decides on treatments to be reimbursed by the country’s National Health Service, originally kept Aricept off its formulary. Following a lawsuit by patient advocates, N.I.C.E. now permits Aricept and similar drugs, but its report on the drug’s value remains skeptical.

Aricept and its analogues are in no way curative and may slow, but do not prevent, progression of the disease from mild to moderate to severe stages. The side effects are so difficult for many users and study subjects that they quit the drug. Most common are diarrhea and nausea; others include insomnia, muscle cramps, abnormal dreams, slowed heart rate and dizziness. University of British Columbia researchers concluded, “Trial reports tend to exaggerate beneficial effects and underestimate adverse side effects.’’

The median retail price for Aricept is about $2,220 a year, according to Thomas Lackner, a professor of pharmacology at the University of Minnesota. Some Medicare drug plans pay for it and some don’t, with wide-ranging deductibles and co-pays. Most people using Aricept take many other medications as well and thus have considerable drug costs, even with the latest Medicare benefit.

Consumer Reports placed Aricept at the top of its list of recommended Alzheimer’s drugs, but also said, “The burden of cost for other medicines may be too great to justify another drug with a high co-payment if there is only a marginal chance the drug will bring them any benefit.’’

Dr. Jerry Winakur and Dr. Cheryl Woodson, both geriatricians and the adult children of parents who died of Alzheimer’s disease, say that neither as clinicians nor as caregivers are they impressed by Aricept and its ilk. Dr. Winakur, who wrote of his dual experience first in an essay in the journal “Health Affairs,” worried of the dangers of side effects to patients with dementia caused by something other than Alzheimer’s disease, which can only be conclusively diagnosed at autopsy. Dr. Woodson said that even if drugs like Aricept slightly improved function and mood and decreased agitation, they do not “really decrease overall caregiver burden,’’ as some claim.

An Alzheimer’s patient doing well on Aricept may call out for a caregiver 60 rather than 80 times a day. In her Chicago suburb, Dr. Woodson wrote in an e-mail, the cost of one month of Aricept would pay for one day a week in adult day care. Wouldn’t a caregiver be better off with total peace and quiet for one day a week?

Dr. Finucane told my colleague Denise Grady that he understood the helplessness of anyone watching this “slow-motion disaster.’’ “There is an overwhelming desire to do something,’’ Dr. Finucane said, “even if it’s to buy a useless pill everyday.’’

These are the caregivers to whom the advertising speaks. In 2005, direct-to-consumer advertising cost drug companies $4.2 billion, or $11 million a day, according to an editorial in the New England Journal of Medicine published in August 2007. Many critics say these ads should be on the health reform hit list. “Start by reversing the F.D.A. ruling and banning DTC advertising,’’ a recent editorial in the Los Angeles Times said.

Ethicist Daniel Callahan of the Hastings Institute asked yesterday in a blog post whether drugs like Aricept are worth the money spent on them: “That question seems to me appropriate and necessary, but our culture and our health care system all conspire to reject it for serious consideration.”

Dr. John Abramson, an instructor in primary care at Harvard Medical School and the author of “Overdosed America,” said in an e-mail exchange, “Unless health care reform adds this issue it will fail – except to transfer more money into the coffers of the medical industry.’’

For now, though, what’s to stop a daughter from hoping and spending when all she wants is lasagna at Mom’s?