Are the National Institute on Drug Abuse and Big Pharma in Bed

Nora Volkow, M.D.

At the annual meeting of the American Psychiatric Association (APA) in San Francisco in May, Nora Volkow, the director of the National Institute on Drug Abuse (NIDA) was just brimming with a lot 'o news about the square of the hypotenuse. No, I'm sorry, I mean about how much more we know about drug abuse because of brain imagining techniques. This new knowledge she spoke of was summarized in the Psychiatric News, the newspaper of the APA, in the June 21 issue.

The gist of the story was that the drugs themselves impair certain brain circuits, which must then be somehow strengthened through treatment.

One of the points she raised is that drugs like methamphetamine cause dopamine receptor signaling to be decreased in the pre-frontal cortex - the part of the brain known to be crucial in executive control (decision making). Thus, the normal brakes on someone indulging in something are supposedly damaged.

If this be true, one might think that she would be up in arms about the widespread, indiscriminate use of amphethamines like Adderall in children. At the very least, a high percentage of ADHD diagnoses are given to kids suffering from the effects of living in a chaotic environments of one sort or another, and for whom family therapy would be the most important treatment. Perhaps there are some cases of ADHD that are due to neurotoxin exposure or something like that in which the benefits of the use of stimulants outweigh the risks - a questionable assertion itself since the average academic gain for ADHD-diagnosed kids on stimulants is all of about three whole months.

For some reason, however, while she acknowledges in other venues that prescription drug abuse, including that of stimulants, is a major problem, she continues to maintain that stimulants are safe and effective when used for ADHD.

She does admit in one article that ritalin basically works the same way in the brain as cocaine! So is she saying that there is some point at which the alleged adverse affects on executive functioning she was going on and on about at the APA magically become inconsequential?

And yet, she also spends some of her time exaggerating the adverse effects of the devil weed , marijuana, in a campaign to keep it illegal.  It seems there is a double standard she has towards the risks of the drugs sold by Pharma compared to those that are not.

How much worse than the physiological effects of pot, one might ask, are the adverse effects on potheads of jailing them and turning them into felons for the rest of their lives. Or the risks to black kids? They are no more likely than white kids to smoke pot, but are four times more likely to be arrested for it. These are not adverse effects?

"Think about it: Do you want a nation where your young people are stoned?" she was quoted as asking.  I hate to break this to her, but any kid who wants to get marijuana already can. It's like one of the biggest cash crops in several states.

I don't think she has come out in favor of prohibition against alcohol or tobacco, two substances with far more potential adverse physiological effects than pot ever thought about having, so that she might at least be consistent. Does she think that young people aren't already getting "stoned" on booze? As mentioned, she does not seem to be all that concerned about the adverse effects of the stimulants - that she herself describes - when used for legal and "proper" uses. More on that in a sec. Nor does she mention that prescribed stimulants are diverted to "non-medical" uses far more often than even opiates!

It seems almost like she thinks the risks of drugs are entirely dependent on whether or not drug companies make money from them.

I am not surprised by any of this. Many years ago I listened to a talk from someone from NIDA about the horrible effects of dopamine depletion in the brains of regular amphetamine users.  I thought about getting up and asking a question, but someone beat me to it. "Doesn't this happen in kids taking stimulants for ADHD?" the fellow asked. 

The answer? "But the drugs work so well!" As if that were an answer. Now I don't know if NIDA and Big Pharma are in bed together, but that answer sure made me wonder about it.

Another truely breathtakingly bizarre point Volkow made at the APA, as reported in the newspaper (unless the journalist got it wrong):

"Among both lab animals and humans, voluntary initiation of drug use leads to subsequent loss of control and development of addiction among 10% of subjects. The lab rats and mice are uesful for refuting old stereotypes.

Some people still consider addiction moral turpitude, she said. 'But how can you develop the same phenotype in a rat, who have no moral precepts?'"

This argument is a bit of a straw man, since thoughtful mental health professionals these days are not so much concerned with the issue of sin, but more with the question of whether or not drug abuse is due to deliberate and purposeful self-destructiveness. The fact that the 10% figure applies to both rats and people seems to argue for some sort of genetic cause, does it not?

But rats having the same phenotype as human beings? Really?!? I personally have never met any rat that understands the negative effects that a drug might be having on it, or that is able to anticipate the future consequences of continuing to imbibe. People do have these abilities. Furthermore, as I have already pointed out in various venues, scientists still have yet to locate any rats that hide bottles of alcohol.

And now back to that whole executive functioning thing. Methinks she is grossly exaggerating certain of the risks from drugs used entirely to get high. (Anyone remember the scourge of "crack babies?"  Turns out that was all one big - and racist - lie).

Seems to me the supposed "impairments" in executive functioning in addicts that she talks about are awfully specific and limited. In the past, a lot of cocaine addicts, for example, used to burglarize houses and fence the goods to support their habits without even getting caught. It would seem to me that quite a bit of executive functioning is being exhibited in that endeavor. Imagine what master criminals they might be if they had unimpaired executive functioning. It boggles the mind!

And if addicts do have a sort of brain damage, how can some of them suddenly just stop using after attending just one meeting of a 12 step program, and then stay sober by continuing to be in the program? Not as many as we'd like, but still many do. The 12 steps were based originally on techniques used by Protestants to get others to adopt their religious beliefs, not treat brain dysfunction. So how is it that what is essentially a change in cognitive beliefs can fix a brain overnight?

I have argued that many of the brain changes observed in MRI studies are actually conditioned responses due to neural plastic changes in brain structure and function in response to the social environment (No, not all of the observed changes. Some can indeed be due to drug effects, trauma, or disease. Duh). The conditioned changes can indeed happen in relatively short time frames. But literally overnight? Please.

States Pick up Where Feds Left Off in Fining Drug Companies for Deceptive Advertising

After the Feds did their job, the states are now getting into the action.  Pharmaceutical companies are now starting to be fined in state courts for fraudulent promotion of their psychiatric medications.

Anyone who is still wondering why there has been an explosive increase over the last two decades in the use of two classes of psychiatric medications  - so-called “atypical” antipsychotic medication and anti-convulsants - for the treatment of a variety of diagnoses for which they are not indicated need look no further than to my previous posts about U.S. Department of Justice fines levied against pharmaceutical companies for said fraudulent promotion. (2/17/10, 3/22,10, 3/27/10, 4/28/10, 4/30/10, 10/1/10, 12/20/10).  

This blog has also focused on how, with an enthusiastic assist from pharmaceutical companies, the definitions of the psychiatric disorders for which the drugs actually are indicated have been expanded to the point where they are in danger of becoming FUBAR’S (F***’d up beyond all recognition).

To summarize what the US Department of Justice previously found:

May, 04. American pharmaceutical manufacturer Warner-Lambert agreed to plead guilty and pay more than $430 million to resolve criminal charges and civil liabilities in connection with its Parke-Davis division’s illegal and fraudulent promotion of Neurontin.  One of these uses was for bipolar disorder.  Studies later indicated the drug was ineffective for bipolar disorder.

January, 2009. Eli Lilly pays a settlement to the DOJ of $1.4 billion for concealing side effects and off-label marketing of Zyprexa just as their biggest seller, Prozac was about to go off patent in 2001.

September, 2009. Pfizer agrees to a settlement for $2.3 billion for off label marketing of several drugs including the atypical anti-psychotic Geodon

April 2010 - AstraZeneca fined $520 million – off label marketing of Seroquel.

April 2010 - Ortho-McNeil-Janssen Pharmaceuticals Inc., fined $81 - off label marketing of Topamax.

September 2010 - Novartis Pharmaceuticals Corporation fined $422.5 million off label marketing of Trileptal.

December 2010 – Elan Pharmaceuticals fined $203 million – off label marketing of Zonegran.

Now the states of South Carolina and Arkansas have fined Ortho-McNeil-Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson, for overstating the effectiveness and minimizing the risks of their antipsychotic medication Risperdal.

The following summaries of what happened are paraphrased without permission from the American Psychiatric Association’s Psychiatric News.  These legal actions were also widely reported by the press throughout the country.

First was South Carolina, from January of 2012:

A South Carolina judge upheld a $327 million civil penalty against Johnson & Johnson for overstating the safety and effectiveness of Risperdal.  A  jury had decided that they violated consumer protection laws by sending doctors a misleading letter in 2003 about this. The jurors also determined that the warning-label information was deceptive.  They found that the company had falsely claimed that Risperdal was better than competing drugs in a letter was sent to some 700,000 doctors nationwide,. The Food and Drug Administration (FDA) issued the company a warning letter about false and misleading claims that minimized risks such as diabetes and overstated the drug’s benefits. South Carolina’s law allows a judge to decide whether the company can be fined as much as $5,000 for each letter sent to South Carolina doctors.

Arkansas got involved just recently:

Johnson & Johnson "lied to patients and doctors" in its claims about Risperdal, said Arkansas Attorney General Dustin McDaniel, after a jury found the company guilty.  This is the latest case regarding fraudulent claims about the company's second-generation antipsychotic). The jury determined that the company downplayed and hid risks associated with the drug, which has been linked to increased risk of stroke and death in elderly dementia patients and to seizures, weight gain, and diabetes. After the jury's decision, Arkansas Circuit Court Judge Tim Fox, issued a penalty of $1.19 billion for the nearly 240,000 violations of the state's Medicaid fraud law. The New York Times reported that he also fined the company $11 million for violations of the state's deceptive practices act. 

Like the title to one of my previous posts, the hits just keep on coming.  Unfortunately, the companies are treating these fines as a cost of doing business and are still making huge profits on these medications.  They know quite well that the damage has already been done.

With Rispiridal, it’s kind of a shame, since in my clinical experience its side effect profile in some ways actually does compare somewhat favorably with two of its main competitors -  for patients who are actually psychotic, of course.

Yet Another Drug Company Fined for Off Label Marketing of Psych Medication

Since I started this blog way back in March of 2010, I have posted several times about big Pharma companies being fined for the off-label marketing of various psychiatric medications. Well, the hits just keep on coming.

The Consumerist was one of several news sources to recently report that: 

"New York Attorney General Eric Schneiderman announced the settlement Thursday resolving allegations that Bristol-Myers Squibb improperly marketed and promoted the drug Abilify.

Abilify — the brand name for the prescription drug aripiprazole – is a second-generation antipsychotic prescription drug, commonly, commonly referred to as “atypical antipsychotics,” that were originally used to treat schizophrenia.

According to the states’ complaint, which was also filed today, BMS engaged in off-label marketing, which is the promotion of drugs for uses that are not FDA-approved.

For example, the complaint claims that BMS improperly promoted Ability for pediatric use and for use in elderly patients with symptoms consistent with dementia and Alzheimer’s disease.

This, despite the fact that in 2006, Abilify received a “black box” warning stating that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death.

Additionally, the complaint alleges that BMS violated state consumer protection laws by misrepresenting and minimizing the risks of the drug including metabolic and weight gain side effects and by misrepresenting the findings of scientific studies.

Under the proposed agreement, BMS is prohibited from promoting Ability from off-label uses; making false or misleading claims about the drug; compensating health care providers for attended promotional activities; using grant funds to promote Ability; and providing samples of the medication to health care providers who do not intend to use it for labeled purposes."

Bristol-Myers Squibb settled the claims with 43 states for a total of 19.5 million dollars. That sounds like a lot of money, but for big drug companies, it is actually a paltry sum. Fines like that are considered a cost of doing business

As readers know, I am rabidly against the use of antipsychotic medications in non-psychotic children, which is unfortunately becoming more and more common. However, I must admit I have negative feelings about that black box warning regarding the use of any (not just Abilify) antipsychotic medication in patients in nursing homes with advanced dementia due to Alzheimer's disease or other severe brain conditions. 

Things have gotten to the point where docs are afraid to prescribe these medications even in such patients who are actively psychotic with hallucinations and/or paranoid delusions, for which there are no other effective treatments.

Even in non-psychotic demented patients, antipsychotic meds are often the best agents for controlling assaultive behavior in this population. Unlike other sedatives, they do so while only minimally exacerbating memory and cognitive deficits in these people. Our society seems to want to pay nursing assistants only the minimum wage to take care of our impaired family members as they age. Long-term facilities are very expensive as it is. Not only that, but we under-staff them as well. While there may be psychosocial interventions which would reduce assaultive patients with dementia, we do not want to pay people to provide them.

Given those conditions, what is left? Medications, that's what. Do we really want to expose underpaid and overworked caretakers to dangerous aggressive behavior from patients who basically have no life anyway - just to prevent a tiny percentage of them from dying a little sooner due to the medications' cardiovascular side effects? Time to either pay up or shut up.