Health Business Blog

Listened to Prozac. Should not have.

See Prozac, used by 40m people, does not work say scientists.

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Perfume makers are moving toward purer ingredients for their products. The main motivations seem to be the opportunity to patent individual odorants and the ability to enhance the allure of their scents. But there are some side benefits, the most important of which is making progress toward perfumes that don’t trigger asthma.

From the New York Times (Ahhh, the Seductive Fragrance of Molecules Under Patent)

Jean Jacques, Takasago perfumer, put Thesaron in Altitude, for example, because it solved three problems: Thesaron has the fruity/rosy note of a very expensive class of molecules called rose ketones, but it costs far less and can be used in unlimited amounts (rose ketones are restricted because they set off allergic reactions at high doses)…

Each year, Givaudan scientists develop over 2,000 new molecules. After scent evaluation, synthesis studies and toxicity testing,”only three or four per year are selected for launch,” Ms. Greene said…

The bulk of I.F.F.’s fundamental research spending goes to new molecules, and I.F.F. supports a large interdisciplinary scientific team…

Each molecule is assessed for potential commercial value and each must pass toxicology tests…

If all this effort leads to asthma-safe perfumes, a lot of people will be relieved.

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Have you heard about Not Quite What I Was Planning: Six-Word Memoirs by Writers Famous and Obscure? SMITH magazine asked readers to write their memoirs in six words, then published the results. I’ve seen a sampling and they’re not bad.

For kicks I may try my hand at converting some of my blog posts to that format. Here’s the first:

Patient safety: more than washing hands.

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The press is giving plenty of attention this week to a study suggesting a connection between childrens’ salt intake and obesity. Two years ago on this blog, Mickey hypothesized much the same.
Here’s what we wrote in 2006 (Can blogging boost the rate of progress in medicine?):

A few times in the past year I’ve eaten meats or baked goods that turned out to have a lot of salt in them. Since I usually don’t have much salt, the events are noticeable. Not surprisingly I get a taste of salt in my mouth, but interestingly I get a huge craving for sweet things.

I’m wondering if such an effect occurs chronically in people who eat a much higher salt diet than I do. The prediction would be that people with higher salt consumption would have a higher consumption of free sugars and therefore have other consequences such as obesity and dental problems.

One could imagine that the high amount of salt in ready-to-eat foods is one of the factors underlying the high rate of obesity.

And here’s the new study, as reported in the Daily Telegraph (Cut children’s salt intake to fight obesity):

Children who eat a lot of salt also consume more sugary drinks, increasing their risk of obesity, scientists have warned.

British researchers claim that cutting a child’s salt intake by half can lead to a drop in the number of cans of fizzy drink they consume.

Children who halved their consumption of salt to 3g per day also cut out two cans of fizzy drinks a week, reducing their total calories by 250 a week.

Salt is well known to increase thirst but because children are more likely to drink sugary cola and pop than water to quench their thirst, those who have a diet high in salt are also more likely to be overweight.

Scientists predict a quarter of children will be obese by 2050, leading to an big rise in the number of cases of type 2 diabetes, heart disease, stroke and cancer. The research, published last night in Hypertension, the journal of the American Heart Association, found lowering salt consumption by 1g a day would reduce consumption of sugary drinks by 27g a day.

The study postulates that children drank sweet soda because they were thirsty, but Mickey suggests they may have craved both liquid and sweetness.

It was the intent of our original post to provoke inquiry into this connection, and while we don’t know if we had anything to do with this study we’ll declare victory anyway!

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The latest edition of the Health Wonk Review is up at GoozNews.

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Change of Shift, the nursing blog carnival, is up at CRZEGRL.NET.

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Most people know that off-label use of drugs is rampant, but not everyone may know its extent or history. In the WSJ article U.S. FDA gives boost to off-label drug use, the authors discuss the proposed FDA guidance which would allow drug and device companies to disseminate articles that discuss unapproved uses.

“The regulator is stepping into a high-stakes business issue, because off-label uses of prescription drugs are a mainstay of the industry — an estimated 21% of drug use overall, according to a 2006 analysis published in the Archives of Internal Medicine.  Drug makers are generally expected to welcome the proposal because it clarifies a blurry legal area. At least under certain conditions, it promises a haven for a controversial promotional practice. It also contains an argument from the agency that may help the companies in court cases about marketing practices.”

Interestingly, the authors failed to mention that this really isn’t a new guideline at all.  In fact, in the FDA press release and draft guidance, they gave the history and context for this proposed guideline which was enacted in 1997 and expired in 2006:

“Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of such materials was not viewed by the FDA as evidence of an intent to promote the product for an “off-label” use. However, Section 401 expired on Sept. 30, 2006.”

Furthermore, it gives very specific conditions that must be met, including detailed descriptions of the “types of reprints/articles/reference publications and the manner in which to disseminate scientific and medical information.” For example,

“Some of the principles include ensuring that the article or reference be published by an organization that has an editorial board. The organization also should fully disclose any conflicts of interest or biases for all authors, contributors or editors associated with the journal article. Articles should be peer-reviewed and published in accordance with specific procedures.”

However, the new guidelines omit some previously outlined safeguards. According to a Modern Healthcare article,

“[The previous FDA guidance] had required companies to submit medical journal articles in advance to the FDA and agree to file within three years a supplemental new drug application for the off-label use it wanted to promote. Yet, these important safeguards are nowhere to be found in the new proposed guidance, said Sidney Wolfe, director of Public Citizen’s Health Research Group, in a written statement.”

I believe that this is an important guideline that should be closely examined.  The intent is to provide physicians with “truthful and non-misleading” information that can be used for evidence-based decision making.  I would support this guideline with the appropriate safeguards in place to ensure patient safety and promote public health.

Feel free to send your own comments and suggestions to the FDA by April 15, 2008 to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.

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A couple of letters and an op-ed in today’s USA Today got me thinking, just how much should we expect patients to take responsibility for?

A series of letters addressed an earlier article on fill errors at retail pharmacy. Such errors are actually very rare, but they can have serious consequences and are easier for patients to document than errors that occur in a physician’s office or hospital. Two of the letters suggested reasonable roles for patients.

Steve Giroux, president of the National Community Pharmacists Association wrote:

…[A]s patients, we must insist on a relationship with our pharmacist, as well as with our physician…

As health care continues to evolve, the only way we can be assured high quality care is by asking questions and remaining informed. Don’t let a busy pharmacy discourage you. Wait to speak directly to the pharmacist or come back later. As a pharmacist, I do my best to counsel my patients, and I encourage all my colleagues to insist upon the same standard.

Giroux’s group represents community pharmacists, i.e., those not in the big chains. Traditionally those pharmacists pride themselves on doing more counseling than their chain store equivalents. However in recent years the distinction has become more blurred as the larger chains have realized the importance of counseling. The automation they’ve put in place (ironically cited as a driver of medication errors in the original article) actually allows the pharmacist to spend more time with patients.

I agreed only partially with Dr. Vicki Rackner, who wrote:

If you went to a drugstore and the clerk grabbed the wrong developed photos or gave you the wrong change, you would recognize the error and speak up. Why do we not invite the same customer contribution when it comes to prescription medication? After all, the patient has the most to lose with medication errors.

Rackner goes on to describe the importance of inviting the patient into the practice of medicine, and I think that’s generally right, but there are some problems with the example above. It’s easy to recognize when pictures are not of your family, and counting change is something that’s an everyday experience and taught in school. Photo clerks and cashiers don’t have major educational requirements. Meanwhile, patients are unaware of the names of prescription drugs –many of which are confusing, similar sounding, come in different formulations, and are referred to by both their brand and generic names– and pharmacists usually have six years of post-secondary training and are highly regulated.

Robert Lipsyte, in an op-ed piece on practical concerns for patients, repeats the now-common suggestion that patients ask their physicians if they’ve washed their hands. He acknowledges that it’s hard to do:

I think the toughest question to ask a health care provider about to touch your body is, “Did you wash you hands?”

…It is well-known that thousands of Americans die every year from diseases contracted in hospitals. But most patients don’t ask the toughest question because they are not comfortable enough with their doctors or the medical environment to do it in a friendly, non-challenging way, and they are afraid of causing antagonism. We need to be made equal partners in the system so we can talk freely.

I agree with Lipsyte that it’s hard to do this. I personally have a hard time asking a doctor if he’s washed his hands and generally don’t. It probably is worth doing –just because of the dangers potentially avoided– but I also think it’s completely outrageous to think it’s a reasonable responsibility for the patient.

As I’ve said before (Where’s defensive medicine when we need it?), we don’t ask our pilot if the plan has fuel, if he’s closed the door, or if the runway’s long enough. We don’t remind fire dispatchers to send trucks that have ladders if we’re on the 3rd floor, to put air in the tanks, or to make sure to write down our address. We don’t ask lawyers if their advice is based on the law, and so on. We shouldn’t have to remind physicians of the most basic safety issues.

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The CDC reports that suicide rates are up significantly for the 45-54 population. See Midlife Suicide Rises, Puzzling Researchers in the New York Times. Could this group’s success in reducing cholesterol levels have something to do with it?

A new five-year analysis of the nation’s death rates recently released by the federal Centers for Disease Control and Prevention found that the suicide rate among 45-to-54-year-olds increased nearly 20 percent from 1999 to 2004, the latest year studied, far outpacing changes in nearly every other age group.

The lack of concrete research has given rise to all kinds of theories, including a sudden drop in the use of hormone-replacement therapy by menopausal women after health warnings in 2002, higher rates of depression among baby boomers or a simple statistical fluke.

At the moment, the prime suspect is the skyrocketing use  –and abuse– of prescription drugs. During the same five-year period included in the study, there was a staggering increase in the total number of drug overdoses, both intentional and accidental, like the one that recently killed the 28-year-old actor Heath Ledger. Illicit drugs also increase risky behaviors, C.D.C. officials point out, noting that users’ rates of suicide can be 15 to 25 times as great as the general population.

Jeffrey Smith, a vigorous fisherman and hunter, began ordering prescription drugs like Ambien and Viagra over the Internet when he was in his late 40s and the prospect of growing older began to gnaw at him, said his daughter, Michelle Ray Smith, who appears on the television soap “Guiding Light.” Five days before his 50th birthday, he sat in his S.U.V. in Bloomfield Hills, Mich., letting carbon monoxide fill his car.

When the first papers to document the efficacy of anti-cholesterol medications came out, it was surprising to discover that the studies being cited for benefits in reducing heart disease also showed an increase in total deaths. The deaths were from diverse causes, including car accidents and suicides. It later turned out that many of these medications interfered with sleep, perhaps explaining the car accidents. I wonder if there is also an effect to make suicide more likely. The timing fits well with the increase in suicides described in this article.

Subsequent studies have shown some linkage between low and declining cholesterol levels and suicide. For example, see Serum cholesterol concentration and death from suicide in men: Paris prospective study I in the BMJ.

This is highly speculative but as long as we’re looking for suspects (beyond “a simple statistical fluke”) it’s probably worth looking into.

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Check out the latest edition of Grand Rounds at DailyInterview.com.

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