The Four Rights

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  • 08/19/2008

Yes. I read Reader’s Digest.

And I’m honored to be included in their September story, “Prescription Medicines New and Old; What to consider when your doctor prescribes a new drug.”

Here’s the teaser blurb from the Digest’s website:

All things being equal, it's prudent to take older drugs whose side effects are known instead of new drugs that have less data.

"It has always been unfortunate but unavoidable that some adverse effects may not become apparent until a drug has been in wide use," says Peter J. Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner for the FDA. Sometimes it takes years and millions of users for a pattern to emerge.

When you get a prescription for a new drug, ask your doctor why the new drug is a better choice for you than something long on the market. Also ask about any known serious side effects. And read any printouts from the pharmacy before you take a new medication.

Speak up. Trust your instincts. If you experience any new physical or mental symptoms, consult your pharmacist or physician as soon as possible. Report any adverse side effects to the FDA (www.fda.gov/medwatch or 800-332-1088) and the pharmaceutical manufacturer.

I haven’t seen the complete article yet, but during my interview I spoke at length about the importance of (1) avoiding the Precautionary Principle -- the luddite tenet that preaches that we do nothing until we know everything, and (2) moving towards personalized medicine – and why molecular diagnostics is the key to providing “the four rights” -- the right medicine in the right dose at the right time to the right patient.

So it’s exciting to hear that Medco Health Solutions (the large U.S. manager of prescription drug benefits) has agreed to work with the FDA to research the role of genetics in the safety and effectiveness of drugs.

Medco, will help the FDA assess obstacles to the use of existing genetic tests as they relate to the prescribing of medicines, as well as new opportunities for such tests.

Medco will deliver a series of reports to the FDA under the agreement, which runs until Aug. 31, 2010. Areas of study include the safety of prescription drugs, physician participation in pharmacogenomic testing, and the usefulness of such tests in prescribing.

The first projects will likely be determined this fall and that the initial areas of study may be oncology and HIV/AIDS. The company has two other research collaborations involving pharmacogenomics. One, with the Mayo Clinic, is studying the use of warfarin, a difficult to use blood thinner that can cause serious bleeding in some patients and the other with Laboratory Corp of America Holdings is studying the use of the breast cancer treatment tamoxifen.

According to Reuters, "Medco seeks to lower drug spending for its clients, which include health plans and large.employers, and sees pharmacogenomics as a potential way to control costs and improve quality of care."

That’s the way to lower costs the right way. Rather than denying care, we need to focus on the four rights. That will lead to better care more swiftly and reduce adverse events.

The complete Reuters story can be found here.

In the Reuters story, Medco Chief Medical Officer Robert Epstein said, "The big-picture goal is to facilitate the uptake of appropriate pharmacogenetic testing in the marketplace. It can't really happen if you don't have good information about both the science but also the practice of medicine."

Epstein added that a more comprehensive understanding and use of genetic testing "should take trial and error out" of prescribing and "make people feel more confidence in the drugs they're being placed on because they know for them personally that drug should work.”

And that’s something that’s important not just to us healthcare policy wonks – but to the readership of Reader’s Digest. The real America.

It's time for America to stand up and demand that our elected representatives allow the FDA to aggressively pursue a well-funded Critical Path program. It's time for America to stand up and demand its rights-- "the four rights" -- to personalized medicine.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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