Healthy Policy

Better pharmaceutical safety

Commenter Martin has started his own blog, and I want to be sure to link to it before I end my tenure here.  He's got an interesting post up about a recent NEJM series debating the various conduits to improved drug safety.  What's clear from his post, and the expert's writings he excerpts, is that there's no easy answer for reforming the FDA.

In my mind, a few things need to happen.  Last year the NIH introduced a strict set of new ethics requirements.  These rules were not extended to the FDA, to its detriment, as former commissioner Lester Crawford proves quite well.

But we do have to think seriously about the question of improving drug safety in practical ways.  Many have called for more extensive/longer clinical trials.  That will delay necessary treatments for years.  A better method of ensuring safety is to simply forbid the pharmaceutical companies from operating their own clinical trials.  Study after study has shown that when corporations run their own trials the drug is much more likely to come out positively. 

These results should be public as well; it's ridiculous that we let these corporations put potentially dangerous products on the market but keep questionable safety information to themselves. 

Stop lookin over my shoulder!

There are 90,000 drug reps in this country. 

That, and other interesting tidbits in today's New York Times article. 

Aspirin, Pharma, and You

The Wall Street Journal took a gander at the number of "aspirin resistance" papers in the last few years and found some peculiar trends.  Namely, that there's been a lot of talk all the sudden about aspirin resistance.

For my fellow non-health care practitioners, aspirin resistance basically means aspirin doesn't lower your blood pressure or prevent clotting like it should, and therefore you must need some other expensive prescription medication.

A dozen papers were published in 2002 alone examining this condition, and many more have followed.  Besides confusion over the correct way to identify patients with aspirin resistance, researchers don't know if these people can actually be helped by other medications either.  And most experts agree that the number of people with such resistance is quite small.

The pharmaceutical industry doesn't see it that way, and has seized the opportunity to promote sales of prescription products like Plavix along with the tests that measure aspirin resistance.  Their efforts, propelled by publicization in medical and trade journals, are working.  Producers of laboratory tests that measure aspirin resistance have seen their sales grow in double digits.  And Medicare ordered 43,000 such tests, twice as many as it did only two years ago. 

Aspirin resistance could be potentially devastating for those it affects, and heart surgery and hospitalization is certainly much more expensive than these tests.  But a doubling of tests for this rare condition in two years is troubling, and points to physician pressuring (and caving), non-disclosure of conflicts of interest, and plain old improper focus of research dollars (see my previous post for a better location). 

190 subpoenas for pharma

Bad news for pharma:

The Federal Trade Commission on Wednesday announced that it plans to subpoena 190 drug companies in an investigation of possible anti-competitive practices in the pharmaceutical industry, the AP/Los Angeles Times reports. The subpoenas, which require approval from the Office of Management and Budget, would be part of a probe into whether pharmaceutical companies are suppressing competition by releasing authorized generic versions of their own brand-name drugs to coincide with the introduction of products from generic drug makers. Under federal law, after a generic pharmaceutical company successfully challenges a patent held by a brand-name manufacturer, it has six months of exclusivity to sell the drug in the generic market by itself. However, a loophole allows brand-name manufacturers to authorize their own generic versions, which increasingly are entering the market at the beginning of the six-month exclusivity period. Generic drug manufacturers depend on that exclusivity period to recover their costs and make a profit, but with authorized generics entering the generic market sooner, profit margins are falling for generic manufacturers.

If definitely appears that this is an industry-wide practice, given that such a large number of firms are receiving subpoenas.

What I meant was...

Go read this.

Hungry?

So that sleeping medicine Ambien?  Apparently it does funny things to you:

The sleeping pill Ambien seems to unlock a primitive desire to eat in some patients, according to emerging medical case studies that describe how the drug's users sometimes sleepwalk into their kitchens, claw through their refrigerators like animals and consume calories ranging into the thousands.

The next morning, the night eaters remember nothing about their foraging. But they wake up to find telltale clues: mouthfuls of peanut butter, Tostitos in their beds, kitchen counters overflowing with flour, missing food, and even lighted ovens and stoves. Some are so embarrassed, they delay telling anyone, even as they gain weight.

The reactions range from fairly benign sleepwalking episodes to hallucinations, violent outbursts and, most troubling of all, driving while asleep

Pharma and medication compliance

This article from the New York Times is a good read.  Drug companies have realized that non-compliance with medication regimens represents billions in lost profits every year as prescriptions aren't refilled on a regular schedule (if they're refilled at all).

Two things come to mind:

It really is better for patients to take their medication as prescribed.  The article cites a blood pressure med commercial that urges patients to take their med as directed.  And they should -- it's tough on your heart and downright dangerous to let your blood pressure skip around.

But the recent reduction in health spending came, in large part, from less utilization of prescription drugs.  If drug company informational campaigns are successful, we can expect to see those savings reversed. 

Two sides to every coin, indeed. 

Unsales reps

One of the proposals from Jerry Avorn's book Powerful Medicines is coming into existence:

The Wall Street Journal on Monday examined a state-funded program in Pennsylvania that sends "unsales representatives" to physician offices to encourage the use of generic and other medications that cost less than brand-name treatments. The program is based on the research of Jerry Avorn, a professor of medicine at Harvard University, who has established a system called "academic detailing," which seeks to encourage physicians to make prescription decisions based on scientific evidence rather than promotions from pharmaceutical company sales representatives. In Pennsylvania, the state Department of Aging through a contractor will pay $3 million to a foundation led by Avorn over three years to implement an "unsales" force to counter promotions by pharmaceutical companies and reduce medication costs for the state. Members of the unsales force visit physician offices and discuss alternatives to brand-name medications, such as generic and over-the-counter treatments or behavioral modifications (Hensley, Wall Street Journal, 3/13).

The key thing here will be if this program can help enact systematic changes.  It doesn't work very well for the state to keep sending "unsales reps" year after year at a hefty price tag.  But if the practice can help change prescribing culture after a few years, it will pay for itself. 

Not keeping promises

65% of Promised Drug Studies Pending

At first glance, that headline gives the impression that 65% of studies are in existence.  That seems pretty pitiful.  But if you read it closely, you see the word "pending", and realize that only 35% of said studies are given life.

Drug companies have launched barely a third of the follow-up studies they agreed to undertake once their new medications were on the market, the government said yesterday.

Often the drugs received expedited approval from federal regulators on the condition that the studies be carried out.

The FDA said it relies on the so-called Phase 4 studies to gather additional information about a drug's safety, efficacy or use. The outcome of those studies can lead to changes in how a drug is made, prescribed and used. The FDA also can require the studies after it has approved a drug.

The pharmaceutical industry does this because we let them.  The extent to which they've been able to game the FDA is almost laughable.  Laughable that the FDA is still able to claim independence and authority at all.

These behaviors won't change without tough rule shifts at the FDA.  The most effective way to do that may be to start a new organization from scratch, with a new crop of officials, ethics rules, and procedures. 

WSJ vs. NEJM

Via Health Care Renewal, the Wall Street Journal goes after the New England Journal of Medicine:

The New England Journal is joining the ranks of academic publications risking their reputations as non-partisan arbiters of good science in order to rumble in the political tarpits.

The facts and timing of the Merck ambush certainly suggest as much. Late last year the New England Journal published an 'Expression of Concern' about a Vioxx study it carried in 2000, baldly accusing researchers of omitting key data to make the painkiller appear more safe.

What has Dr. Curfman [Executive Editor of the New England Journal] in a dither is the fact that three more participants [in the group treated with Vioxx] also suffered heart attacks - although only after the cutoff date that had been determined by an outside safety panel for the study.

In fact, as prominent scientists have since attested, the authors were simply following the rules of science. 'If the outcomes truly occurred after the close of the study, then they don't belong in the study,' Brian Strom, an epidemiologist at the University of Pennsylvania, told Nature magazine. . .

Unfortunately, the attack on Merck isn't isolated, but is part of a growing trend among scientific journals that have joined business-bashing and other liberal campaigns.

To the untrained eye, 3 more heart attacks doesn't sound like a big deal.  But in the context of the study, 3 additional heart attacks increased the rate of heart attacks from 17 to 20.  We call that statistically significant, my friends.  If an organization is supposed to stand up for science, doesn't that mean reporting it?  Not hiding it?  Pharmaceutical companies are the ones keeping science for the sake of science off the table.  That's through multiple efforts, most recently the realization that companies are excluding both the name of the drug studied and final results in several trials on the new clinical trial registry. 

WSJ's "anonymous" (read: pharma lobbyist) op-ed contributor doesn't like the negative press for pharmaceutical companies and decided to nit-pick on one unspoken rule of trial reporting.  But shame on the person arguing that severe events like heart attacks shouldn't be considered because they occurred after the study.  This isn't a game about when adverse events should "count" -- it's health.  Merck seriously paid for hiding their results -- billions of dollars in lost revenue and even more tarnished image. 

Even so, this is a curious op-ed from the WSJ, mostly because the NEJM basically pushed through this new clinical trial reporting system which is now aiding pharmaceutical companies.  NEJM is also chock full of multi-page bright colored pharmaceutical ads.  And historically, if the journal has had any bent at all, it's been to the right.  If anything, NEJM's "expression of concern" was an assertion of power, a declaration from that it won't be used as a pawn in pharma's games and be dragged down in the dirt of public opinion as well.