Generic Drug Plans Focus on Wrong Problem

The Obama Administration plan to put new generic drugs on the street faster is another example of how Washington healthcare reformers just don't get it. While it is true that more generic drugs will reduce healthcare costs, it also is true that health risks will increase for many individuals sensitive to even the slightest changes in their medications.

The Obama drug plan imposes $10 billion in fees over ten years on the brand-name pharmaceutical industry, to be parceled out among big drug makers to eliminate the so-called donut hole, or gap, in Medicare prescription drug coverage. The idea is to help patients continue taking their original drugs instead of switching to cheaper generic versions, or going off their meds entirely.

The plan's second part prohibits pay-for-delay deals, where brand-name drug makers pay generic drug companies to drop patent challenges. Proponents of this idea say pay-for-delay costs Americans up to $3.5 billion each year.

Generic drugs account for more than 70 percent of all prescriptions filled each year in the U.S. at a savings to patients of about $8 billion a year. A different, and insidious, cost to patients comes from the leeway given by the Food and Drug Administration in the manufacture of generic drugs.

The FDA requires a generic drug to be the same as the original in dosage, safety, strength, performance, intended use, and the way it's taken. The rules, however, allow for a 20-percent variation in the active ingredient. In other words, the good stuff may be 80 percent less than, or 20 percent more than, what's in the real deal. This broad range may work for antibiotics, but it creates nasty reactions among patients with heightened sensitivities to their medications.

Internet discussion boards teem with anecdotal evidence. One person tells how his symptoms went away during the year he took the real drug, but returned after three months on the generic version, forcing him to go back to the original that cost seven times more, but with "tremendous results."

A mother describes how her 11-year- old son, who takes several generic anti-seizure drugs, received a different generic for one prescription that made him extremely sedated and "drool like a faucet," which put him at risk for drowning in his own saliva. She calls this another example of why the FDA should tighten its regulations and monitoring of generic drugs.

I don't have to go to the Internet to know about the dirty little secret of generic drugs. My wife has temporal lobe epilepsy, in addition to being very sensitive to generics. We knew generic over-the-counter drugs may include inactive ingredients that cause bad side effects, but we assumed generic drugs were the same as real ones. We discovered the difference when she received a generic anti-seizure drug because our insurance company wouldn't pay for the original. The doctor and pharmacist insisted there was no difference, but a quick search of epilepsy forums turned up person after person with horror stories similar to hers.

Doctors and federal agencies many times require more than a patient's story, which makes you wonder why the people charged with watching out for our health apparently ignore a study by Giuseppe Borheini published in the 2003 issue of Clinical Therapeutics. Borgheini's team looked at available data going back to 1975 that compared the effectiveness of brand-name psychoactive drugs and their generic counterparts.

One of Borgheini's more disturbing discoveries was of a study that showed plasma levels of phenytoin were 31 percent lower after a switch from the original anticonvulsant Dilantin. He also learned that when the FDA investigated the sudden recurrence of seizures on the generic valproic acid substituted for Depakote, it found a difference in how the drug gets to where it supposed to go.

Other data showed statistically significant differences in favor of Valium over the generic diazepam in terms of the body's absorption and distribution.

Borgheini's research led him to conclude the FDA's " essential-similarity requirement should be extended to include more rigorous analyses of tolerability and efficacy in actual patients as well as in healthy subjects."

This would mean the FDA would have to reconsider its formula variation requirement, demand realistic trials of different formulations, and make sure the active ingredient in the generic drug delivers its bullet to the same target as the original drug.

The FDA will say, however, that it doesn't have the resources to guarantee generic drugs do no harm. FDA Commissioner Margaret Hamburg recently told attendees of the annual meeting of the Generic Pharmaceutical Association her agency needs more people to review the 2,000 applications for new generic drugs, a number that's doubled in five years.

Her plan is not to take more time to ensure a generic drug doesn't harm the patient. No, her plan is to charge generic manufacturers an application fee that will fund additional staff to push out more potentially harmful drugs as part of the Obama Administration's effort to make medication affordable to everyone, regardless of the cost to health.