A drug to treat cocaine addiction?

Structure of cocaine (Photo credit: Wikipedia)

A recent study on the use of topiramate for cocaine addiction has been getting a lot of attention. Most of the coverage draws only from the researchers press release.

“Using an intent-to-treat analysis, the researchers found that topiramate was more efficacious than placebo at increasing the participants’ weekly proportion of cocaine nonuse days and in increasing the likelihood that participants would have cocaine-free weeks,” the university said Friday in a statement.

Similarly, Johnson’s team found a significant association between topiramate and both a decrease in craving for the drug and an improvement in the subjects’ overall level of functioning in comparison to a placebo.

Here are a few things you should know.

1. What does “more efficacious than placebo” mean? It means that the number of days subjects did not use cocaine increased to 13.3% or 8.9%. (Depending on how you calculate it.) So, subjects still used cocaine 86.7% or 91.1% of days.
2.  There a history of concerns about the manufacturer of the drug promoting off-label use of the drug.
3. The lead researcher left his last post after losing a whistleblower lawsuit. One of his projects had been accused improperly charging the federal government for time spent on a study. He also attacked the character of the whistleblower.
4. The lead researcher has a financial interest in topiramate.

I’m sure we’ll come up with effective drugs some day, but I’m skeptical that this is one of them.

a “selfish” and “untrusted” professional attitude*

Bankole Johnson, who was featured in HBO’s Addiction documentary touting the use of Topiramate and wrote an anti-treatment screed years ago (my response here), has left his post after losing a whistleblower lawsuit.

A University of Virginia department chairman nationally known for his addiction research has resigned less than 10 months after a subordinate won an $820,000 whistleblower lawsuit filed against the school, officials said Friday.

…

Featured in the 2007 HBO documentary “Addiction,” Johnson is known for his advocacy of medication, rather than 12-step programs or rehabilitation, to treat addiction.

He was named in a lawsuit filed in 2011 by Weihua Huang, a UVa researcher who lost his job after charging that his supervisor altered a grant awarded him by the National Institutes of Health.

Huang claimed Johnson fired him after he reported that Ming Li, a scientist who works in the university’s Center for Addiction Research and Education, misrepresented the amount of time each researcher was spending on a project. The time spent on projects determines how much money each researcher is paid.

Johnson is leaving for a post at the University of Maryland Medical Center.

In short, it appears that Huang reported that the Ming Li and the University of Virginia’s Center for Addiction Research and Education were charging NIH for research that was not performed and was terminated by Johnson for reporting this fraud and had his character assassinated in the process.

Apparently, Johnson also works with Li at ADial Pharmaceuticals and had to declare a conflict of interest for research related to Topiramate:

Earlier this year, Johnson declared a potential conflict of interest in one of his research projects. That led the NIH to put a temporary hold on funding for the work until UVa could come up with an oversight plan, officials said.

“The idea here … is to ensure that whatever the outcome is, it’s based on science and research,” Eric Swensen, a spokesman for the UVa Health System, said when asked about the issue earlier this week.

Johnson cited the potential conflict involving his company, ADial Pharmaceuticals, located in the UVa Research Park off Fontaine Avenue in Charlottesville. ADial’s website lists Li on the company’s seven-member Board of Directors, headed by Johnson as CEO.

The project cited in the potential conflict seeks to examine the effects of Topiramate on people with different genetic makeups, Swensen said. According to ADial’s website, the company is developing two drugs to help treat alcoholism. Topiramate is listed as an ingredient in one of the drugs.

Titled “Pharmacogenetic Treatments for Alcoholism,” the project received $543,690 in NIH funding in 2012. It was supposed to receive $417,578 by the end of this year.

Interestingly, Johnson’s interest is ADial is not new—he founded the company in 2007. And, ADial’s investment in Topiramate is not new—they’ve been working on drugs with Topiramate since at least 2008.

 

* These are the words Ming Li used to describe Weihua Huang to justify his termination