Tuesday, October 09, 2007

migraine news roundup 44

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This week the FDA said they will consider creating a new category of drugs to be sold behind the counter without a prescription, but rather after consultation with a pharmacist. The system would give pharmacists a bigger role in advising patients and may increase accessibility for uninsured patients.

FDA Explores Behind-the-Counter Drug Sales
The FDA will hold a public meeting on November 14 to hear feedback about the "behind the counter" concept, which could make some drugs now available by prescription more widely accessible to patients.

But the effort will meet resistance from heavyweights who market over-the-counter drugs. The Consumer Healthcare Products Association, which represents a wide range of companies from Kimberly-Clark Corp to Johnson & Johnson, opposes a three-tier system.

According to a study published in the journal Cephalagia, Botox injections for migraine prevention are no more successful than placebo. I know people who have had success with them and people who have not, but this study makes me even less likely than I already was to pursue it as an option again.

Botox and Placebo Similar for Preventing Migraines
Before treatment, the participants experienced about 4.5 migraine episodes every 30 days. After treatment, the frequency of migraine headaches in any 30-day period was reduced by about 1.6 episodes in the active treatment groups and by about 1.4 in the placebo group. This difference was not significant from a statistical standpoint.

According to the Archives of Internal Medicine, the number of deaths resulting from commonly used medications nearly tripled between 1998 and 2005.

Analysis: Deaths From Drug Reactions Up

A disproportionate number of complications occurred in elderly patients. Women were more often victims than men, 55.5 percent compared to 45.5 percent. Children were involved in 7.4 percent of the problems.

The FDA issued a statement saying it is aware of the growing number of reported problems and takes them seriously, but the reason for the increase "is not completely known."

"While some of this has to do with the increasing number of prescriptions, there are clearly other factors responsible for this increase, such as the increase in public attention to drug safety, and use of the Internet to make it easier for the public to submit," Dr. Gerald Dal Pan of the FDA's surveillance and epidemiology office said in the statement.

Sen. Charles Grassley, an Iowa Republican and frequent FDA critic, said the report is another indication that the FDA's review of drugs already on the market "must be rigorous and timely."

Contrary to what most of us have always believed, the generic version of a drug may not save you any money.

Why Generic Doesn't Always Mean Cheap

At a time when policy makers are searching for ways to cut health-care costs, generic drugs are often viewed as one of the most straightforward solutions. But as the situation with generic Zocor illustrates, prices can vary wildly, and may not be nearly as cheap as expected. Generics of a number of other notable drugs that came off patent recently -- including the antidepressant Zoloft, the antibiotic Zithromax and allergy drug Flonase -- have also so far failed to deliver big savings in many cases.

"We're not seeing that sharp a drop-off" in price among generic drugs that have come out in the past couple of years, says Jim Yocum, executive vice president of DestinationRx Inc., a Los Angeles pharmacy data and software company. "We're just not seeing it."

Well-known neurologist and author of Migraine, Oliver Sacks, has accepted a unique customized appointment at Columbia University.

Oliver Sacks Joins Columbia Faculty as "Artist"

Lily has added warnings to its drug Zyprexa about weight gain and other metabolic problems.

Lily Adds Label Warnings for Mental Illness Drugs

Internal Lilly documents disclosed by The Times last December indicated that Lilly was aware of Zyprexa’s tendency to cause weight gain and blood sugar changes by the late 1990’s but played down the drug’s risks.

Lilly said at the time of those disclosures that the drug’s risks were already reflected in the label. Ms. Lemons said the company had not delayed releasing information about Zyprexa’s side effects, and had made yesterday’s label change after a new review of clinical trials showed the drug’s potential risks.

The LA Times examines how therapists and patients determine when to end therapy.

At Therapy's End
The answers are not simple. Measuring depression is hampered because there's no physical marker that indicates whether a patient has it or does not. Information about that comes from behavior, thoughts and feelings, which can't be assessed as easily as, say, blood pressure.

Rating scales can show how far symptoms, such as trouble sleeping, have receded, but psychiatrists say they put even more stock in a patient's overall mood: whether he or she takes joy from life again and whether the person thinks he or she is back to a pre-depression emotional state. That too can be difficult to determine.

Now results from large, long-term studies are beginning to paint a clearer picture of the course of depression and are sharpening decisions about stopping treatment. If a person has had just one episode of depression, the chances of a long-lasting recovery are fairly good. But those chances go down with every subsequent episode.

Once people reach their third episode, Leuchter says, "then we need to discuss ongoing maintenance therapy, even if they are feeling better. I don't like to use the phrase 'lifetime treatment' with patients. But, essentially, that's what we're talking about."
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