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The Dolan Company-Dolan Media Newswire Story – December 14, 2010
NEW ORLEANS, LA — Deplin is something of a wonder drug when it comes to treating addiction and depression, said Dr. Howard Wetsman.
So it came as a surprise when many of his patients reported back to him after being prescribed the drug that their symptoms had returned in force and their conditions worsened.
It didn’t make sense, said Wetsman, an addiction medicine physician in New Orleans.
“I ask them if anything has changed and they say, ‘Nope. I’m taking the same medicine.'”
Wetsman pressed further and learned the truth.
When his patients took their Deplin prescriptions to the drugstore, many times the pharmacists informed them there was a more affordable, generic version available.
Not surprisingly, given the harsh reality of the economy, Wetsman’s patients opted for the cheaper version.
And there’s nothing wrong with that, said Jim Currie, director of communications and marketing for Covington-based PamLab, the manufacturer of Deplin. That’s what generics are for, to provide more affordable versions of brand name products and increase competition within the industry.
But this isn’t about generic drugs, he said. It’s about impostor products pretending to be generic versions of brand names and a loophole in the federal system that allows this to happen.
In October, PamLab scored a victory against one of the reported impostors when Manasquan, N.J.-based Seton Pharmaceuticals agreed to change the labeling on Duleek, a dietary supplement mistaken to be the generic version of Deplin.
The label on Duleek now informs consumers it does not contain the same ingredients as PamLab’s product and is not a therapeutic equivalent.
PamLab is also suing Acella Pharmaceuticals based in Alpharetta, Ga., claiming it falsely sold one of its products, Folast, as a generic equivalent of PamLab’s Metanx, a treatment for diabetic neuropathy.
The Louisiana Attorney General’s office is investigating Acella on behalf of PamLab but declined to comment.
Acella and Seton are said to have claimed their products contained L-methylfolate, the active ingredient found in Deplin and Metanx.
All generic drugs must undergo a rigorous testing and approval process conducted by the U.S. Food and Drug Administration to ensure they have the same ingredients as their brand name equivalents. The problem is that L-methylfolate is classified as a “medical food,” a dietary supplement that manages diseases caused by nutritional deficiencies.
Because medical foods are based on active ingredients naturally consumed and processed by the body, they are not subject to same FDA approval process as the majority of pharmaceuticals. That has created a loophole for dishonest generics to crawl through, Currie said.
“They just show up on their own, declare themselves an appropriate generic and no one asks them for the science to verify their claims. They just take them on face value and put them on the market.”
PamLab recently asked the FDA to revise its medical food testing process and eliminate the loophole, Currie said.
“I think ultimately they will fix this but the FDA works very slowly,” he said.
The pharmacists who suggest patients use false generics are not to blame, Currie said. They rely on national drug database systems Medi-Span and First Data Bank to inform them about the availability of generics for name brand pharmaceuticals.
Since medical foods are not subjected to the typical FDA approval process, the database systems make their own determinations about appropriate generic substitutes. It is a subjective and unscientific process, Currie said. If a company like Acella asks to have its product classified as a generic to Metanx, chances are Medi-Span and First Data Bank, who did not respond to requests for comment, will comply.
“We asked them why you linked (the false generics) to our products. They said they were like the Yellow Pages. They said they just link products and don’t make a decision on what is what.”
PamLab has kicked off a campaign called Read First, encouraging pharmacists to read the labels on medical food generics to make sure they are what they claim.
“Pharmacists have been stunned to learn these products listed as generics are not FDA-approved generics,” Currie said.
Now when Wetsman prescribes Deplin, he includes instructions that generics are not to be substituted. Insurance companies do not cover medical foods, making the false generics an attractive option. But the decreased cost is not worth the risk, Wetsman said.
“These products may be listed as medical foods but in the case of Deplin, it certainly has acted more like a medicine than a milkshake.”
When patients are given false generics after experiencing success with the brand name products, the results can be disastrous, Wetsman said.
“People think they’re getting the best care, that everyone from the doctor to the pharmacist is right, but the medicine that worked before is no longer working. So they feel hopeless, that there’s something wrong with them that can’t be fixed. It doesn’t take much to go from there to, ‘I might as well check out.'”
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