Dispense As Written

Reuters recently reported on a new study put out by the American Journal of Medicine in which they post the following:

“Patients are less likely to fill prescriptions when their doctors specify that brand name drugs can’t be substituted with generics, according to a new study. Along with leaving patients without their medications, the practice could be costing the health system almost $8 billion a year, the authors of the study in the American Journal of Medicine calculated. (bit.ly/eZZjHh)”

First off, the article makes no attempt to educate readers as to whether generics are as effective as brand alternatives in all cases. This is a material factor as to whether a patient is going to be willing to opt for a generic drug option. Second, the underlying statistical math seems very loose. The study extrapolates a possible $8B a year savings from a 4% variance between prescriptions being filled when a generic option is given versus not. How they get to $8B in savings is as murky as it gets. The detail underlying the math is left vague and the implication is that physicians are the root cause of this bloated industry cost.

Moreover, they gloss over an odd finding in the study: “But even when patients were the ones who had requested a brand name drug, they were less likely to fill the prescription when they couldn’t substitute generics.” There was no attempt to explain this or how it factored into the math.

I asked Dr. Jeffrey Atkins of St. Louis about his thoughts on the issue. He responded:

“For the most part generic medications are worth a try. There are many categories of medications (hypertension and cholesterol for example) where the medications can be judged by specific tests/numbers – blood pressure readings and cholesterol numbers in these cases.

[However] physicians should insist on brand names for certain illnesses – for example, thyroid disease and seizure disorders. The reason is that there are many companies making generics, and the acceptable range of generics matching brands is too broad. Depending on the pharmacy, they may be switching generics every month.

The government, if they are going to address healthcare, needs to address medications. Stricter regulations are needed so that all generics are closer to the brand version. The problem is that it will cost more.”

I am certainly advocating against generics, but instead using articles like this to highlight the reports and fuzzy math that can lead to very poor personal and/or policy decisions.

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The FDA Kills Innovation

According to a post in FiercePharma, the Obama administration is proposing to shorten the length of biologics exclusivity to seven years from 12 years. This push to get drugs to the less expensive generic market is short-sighted and dangerous.

I went back to a post from Fierce just two years ago as they asked “What can we expect from Obama’s FDA?” Here was the answer:

“The principal question facing President Obama’s FDA will not revolve around drug safety or transparency, says Robert Goldberg, Co-founder and vice president of the Center for Medicines in the Public Interest. Obama’s FDA will have to answer the question, ‘Who lost innovation?’”

The answer is simple: THE FDA IS KILLING INNOVATION!

As Steve Forbes correctly writes in his recent article “How the FDA May Be Killing Us”:

“FDA’s behavior is no surprise to the organization’s watchers: Approve a medication that has an unintended side effect and congressional headline-seekers will be giving officials the third degree. Better to let people die by depriving them of new medicines than to be excoriated by the likes of McCarthyite demagogues such as Representative Henry Waxman (D-Calif.).”

Forbes goes on to quote the recent book by David Shlaes Antibiotics: The Perfect Storm:

“Regulatory agencies like the FDA are contributing to the problem with a constant barrage of clinical trial requirements that make it harder, slower and more costly to develop antibiotics.” Another bad guy: “The National Institutes of Health was for many years [biased] against funding antibiotic research.”

Federal bureaucrats need to stop the bloviating and recognize government is not the answer to innovation it is the antithesis of innovation.

Get out of the way! The new Congress has a lot of work to do, but nothing could have a bigger impact on rejuvenating an innovating environment for drug and device makers than a total overhaul of the FDA.

Do you have a nightmare story of lengthy trials or burdensome regulatory hurdles getting a drug or device to market? Send me your story.