Category Archives: Pharmaceutical

Disease Mongering By Way of Restless Legs

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Yesterday during lunch I saw an ad for Mirapex, a “prescription medicine used in
the treatment of moderate to severe primary restless legs syndrome (RLS).” The
fact that there was such thing as a restless leg syndrome seemed odd to me, so
I did some sleuthing. (Maggie, who has in fact discussed RLS over at the Health Care Blog, has some great
thoughts on the issue as well.)

 RLS is a “medical condition that is described as an urge to
move the legs”—simple enough. The Mirapex website offers a list of question
designed to help you diagnose yourself:

  • Do you feel a strong desire to move your legs from time to time, often when they make you uncomfortable?
  • Do those sensations in your legs occur or get stronger when you are inactive?
  • Does moving around or stretching help ease those uncomfortable sensations in your legs?
  • Do those uncomfortable sensations feel their worst at night?

Boehringer
Ingelheim Pharmaceuticals, the manufacturer of Mirapex, is considerate enough
to translate these symptoms into layman’s terms:

People often use words like
"burning," "creeping," "crawling,"
"aching," "tingling," and/or "tugging" to try and
describe their symptoms. Many people with restless legs syndrome have
difficulty explaining the odd sensations they feel, even when talking to their
doctor.

So far it seems that I may have RLS if my (1) legs get uncomfortable after
sitting for a while and (2) I have trouble articulating this sensation. By
these criteria, most anyone who has uttered the phrase “my leg feels weird”
qualifies as an RLS sufferer.

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Do You Want to Know That You Will Be an Alzheimer Patient in Two to Six years?

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Yesterday The New York Times reported a medical breakthrough: “the development of a blood test that can  accurately  diagnose Alzheimer’s disease, and even do so years before truly debilitating memory loss.”

Well, “accurately” may be a bit of a stretch. As the Times explained, the test is about “90 percent accurate in distinguishing the blood of people with Alzheimer’s from the blood of those without the disease” and “about 80 percent accurate in predicting which patients with mild memory loss would go on to develop Alzheimer’s disease two to six years later.”

Then, the Times acknowledged, there is one other problem with the test:  “At present, treatments for Alzheimer’s disease are not very effective.”

So why exactly would I want an early warning that would give me two to six years to contemplate what it will be like to observe my mind dissolving? (Of course I could comfort myself with the fact that the test is only 80 percent accurate, but somehow I suspect that would only compound my anxieties.)

“There are people who want to know what their future holds so they can plan their estates and lives,” Dr. Sam Gandy, a professor at Mount Sinai School of Medicine in New York who is chairman of the medical and scientific advisory council of the Alzheimer’s Association, told the Times.

Right, this is an estate planning tool.

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Inside the FDA

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I was speaking to a source inside the FDA recently and he explained that since the FDA has committed to reviewing applications for approval of a new drug within 10 months, drug-makers have been submitting “shabbier” applications that contain less evidence about risks and benefits.

“For the drug-maker it’s a gamble. The company is betting that, because we want to make the 10-month deadline, we won’t send the application back,” said the source. And often, he acknowledged, the drug-maker is right. “If you find a problem or there is something missing and it doesn’t seem terribly material, there is a tendency to overlook it. Because if you don’t it will just delay the whole process.”

In the past, he adds, a company submitting an application knew that if the application wasn’t up to snuff, the FDA would send it back. But those standards have fallen: “Now we send it back [only] if it’s really crappy.”

We also talked about direct-to-consumer advertising and why many in the pharmaceutical industry resisted the suggestion that they wait two years before trying to sell a new drug directly to the public. “There is a saying in the industry,” he confided, “[that] you want to get doctors accustomed to using a new drug while it still ‘works’—while it’s still the latest and the greatest.”

In other words, drug-makers want doctors to begin using the drug before everyone discovers that it is not quite the miracle cure that some hoped it would be. Knowing that it takes time to discover the risks of a drug, doctors might not be so quick to take up the absolute newest thing on their own. That’s why companies like to go to consumers who they hope will push their doctors into trying the new products before all the risks are known.

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Drug-Maker’s Direct-to-Consumer Advertising—“Half-True”?

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Earlier this month the FDA announced that the direct-to-consumer ads Merck has been using peddle its new cervical cancer vaccine, Gardasil, are “half-true . . .  information currently being advertised could mislead the public.”

But “don’t get too excited that the U.S. Food & Drug Administration has regained its sanity,” says blogger Bill Sardi.

“This is the FDA in Thailand,” he explained. (Sardi picked up the news in the Bangkok Post)

Before taking a closer look at precisely why Thailand’s health officials  are concerned about Merck’s ads—and why our own FDA isn’t raising a red flag– let’s step back and review our own government’s policy on drug ads that are beamed directly to you and me.

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