Who’s guarding the hen house?

money-pillsFrom the NY Times:

Addiction experts protested loudly when the Food and Drug Administration approved a powerful new opioid painkiller last month, saying that it would set off a wave of abuse much as OxyContin did when it first appeared.

An F.D.A. panel had earlier voted, 11 to 2, against approval of the drug, Zohydro, in part because unlike current versions of OxyContin, it is not made in a formulation designed to deter abuse.

Now a new issue is being raised about Zohydro. The drug will be manufactured by the same company, Alkermes, that makes a popular medication called Vivitrol, used to treat patients addicted to painkillers or alcohol.

In addition, the company provides financial support to a leading professional group that represents substance abuse experts, the American Society of Addiction Medicine.

Hmm. Let’s see,

  • they profit from a drug that will produce addiction;
  • they profit from a drug to treat addiction;
  • they manage to get their drug approved over a very lop-sided FDA panel objections;
  • they fund the American Society of Addiction Medicine (ASAM);
  • they funded the publication of a portion of the ASAM Patient Placement Criteria, which is the dominant framework for treatment placement decisions;
  • another of ASAM’s sponsors makes billions off of a medication with “near universal relapse” when they try to taper patients off it (It’s worth noting that the feds have also invested heavily in promoting Suboxone.);
  • ASAM engages in advocacy for the products these companies produce;
  • ASAM’s professional status and power places it in the position of conferring legitimacy and illegitimacy to treatments and policies;
  • people who questions these treatments and policies are dismissed as crackpots who reject empiricism.

Who makes policy?

[hat tip: Love First]

Addiction diagnoses to rise

I’ve posted before about problems with the proposed approach to addiction in the DSM-5.

These changes were intended to clear up language problems, specifically the conflation of dependence and addiction leading to “false positives” for addiction. Looks like the DSM-5 is causing its own language problems before it’s even adopted. [emphasis mine]

Many scholars believe that the new manual will increase addiction rates. A study by Australian researchers found, for example, that about 60 percent more people would be considered addicted to alcohol under the new manual’s standards. Association officials expressed doubt, however, that the expanded addiction definitions would sharply increase the number of new patients, and they said that identifying abusers sooner could prevent serious complications and expensive hospitalizations.

Further, I’m pretty skeptical of the suggestion that the current abuse diagnostic category constitutes a medical illness requiring any kind of medical treatment, and they are looking forward to the new criteria being more inclusive and being classified as having form of addiction?

The article demonstrates that the inevitable slide into viewing low-severity AOD problems as the first stage of addiction:

“We can treat them earlier,” said Dr. Charles P. O’Brien, a professor of psychiatry at the University of Pennsylvania and the head of the group of researchers devising the manual’s new addiction standards. “And we can stop them from getting to the point where they’re going to need really expensive stuff like liver transplants.”

On top of this, conflicts of interest are being exposed. It’s pretty clear that this would be a major boon for drug companies, particularly with the Affordable Care Act simultaneously increasing access to healthcare for people with AOD problems and increasing physician responsibility to treat AOD problems that they are poorly equipped to address.

Some critics of the new manual have said that it has been tainted by researchers’ ties to pharmaceutical companies.

“The ties between the D.S.M. panel members and the pharmaceutical industry are so extensive that there is the real risk of corrupting the public health mission of the manual,” said Dr. Lisa Cosgrove, a fellow at the Edmond J. Safra Center for Ethics at Harvard, who published a study in March that said two-thirds of the manual’s advisory task force members reported ties to the pharmaceutical industry or other financial conflicts of interest.

Dr. Scully, the association’s chief, said the group had required researchers involved with writing the manual to disclose more about financial conflicts of interest than was previously required.

Dr. O’Brien, who led the addiction working group, has been a consultant for several pharmaceutical companies, including Pfizer, GlaxoSmithKline and Sanofi-Aventis, all of which make drugs marketed to combat addiction.

He has also worked extensively as a paid consultant for Alkermes, a pharmaceutical company, studying a drug, Vivitrol, that combats alcohol and heroin addiction by preventing craving. He was the driving force behind adding “craving” to the new manual’s list of recognized symptoms of addiction.

“I’m quite proud to have played a role, because I know that craving plays such an important role in addiction,” Dr. O’Brien said, adding that he had never made any money from the sale of drugs that treat craving.

Dr. Howard B. Moss, associate director for clinical and translational research at the National Institute on Alcohol Abuse and Alcoholism, in Bethesda, Md., described opposition from many researchers to adding “craving” as a symptom of addiction. He added that he quit the group working on the addiction chapter partly out of frustration with what he described as a lack of scientific basis in the decision making.

“The more people diagnosed with cravings,” Dr. Moss said, “the more sales of anticraving drugs like Vivitrol or naltrexone.”