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Hillary's Mental Health Plan Needs Work

It's silent on two initiatives: Industry corruption and minors with disabilities

Nobody can be against the many worthy initiatives proposed in Hillary Clinton's new Mental Health Plan, just released yesterday (August 29). Better care for vets with PTSD, suicide prevention, getting the mentally ill out of jails: What enlightened person could possibly oppose any of these ideas?

Yet the Clinton proposal is silent on two badly needed initiatives that really would make a difference:

One, dismantling the state legislation that makes access to convulsive therapy (ECT) for those under 18 difficult, if not impossible. With well-meaning intentions, but in a way that was totally misguided, state legislators in California, Texas, and several other states have ring-fenced ECT for under 18-year-olds so that desperate parents are unable to arrange care for their children without expensive and time-consuming out of state travel.

The idea was to "protect" helpless children from their psychiatrists. Don't worry, folks, Old Tex from Abilene is gonna look after the kids.

Autistic and intellectually disabled children who, for example, have Self-Injurious Behavior (SIB) hit themselves continuously. They are at risk of detaching their retinas (and thus going blind) and of cerebral hemorrhages. This is actually quite common. These patients respond to proven treatments, such as benzodiazepines (lorazepam), and, if that fails, ECT, which almost always brings the SIB to an end and gives the children (and their parents) their lives back. Self-injuring children in New York State, for example, may be readily treated.

Children with SIB in California and Texas may not be treated with convulsive therapy. When parents ask psychiatrists, what are we supposed to do? Clinicians merely shrug. "Can't be done here. Have to go out of state."

Of course, the federal government cannot directly intervene in state legislation, but it can exercise leadership. The White House can direct the NIMH to launch publicity campaigns, approach the press, take an advocacy role. The way the White House led on developmental disabilities in the 1960s, beginning with John F Kennedy, and the Congress in the 1970s, with many initiatives launched by Senator Ted Kennedy, was exemplary.

There is a great vat of unmet need in the autism-intellectual disabilities area, most acutely surrounding SIB, and here Hillary can help.

Two, the White House could undertake initiatives to break up the toxic alliance between clinicians known as KOLs and the pharmaceutical industry. Clinicians who perform for the industry's dime are called in the companies' internal memos "KOLs: Key Opinion Leaders." The term has now become an embarrassment to academics who cash in from industry because it identifies them as sell-outs.

Yet there are many KOLs who agree to their names being used on papers reporting clinical trial results without ever having seen the paper, let alone have a hand in writing it. These glowing reports are written by public-relations companies and are called "ghost-written" papers. The practice is very common.

Another ploy: KOLs appear at industry-sponsored meetings to, um, hype the company's products?

No, they are not that crude. More successful is the tactic of discussing, say, antidepressants, and then pointing to the (unacceptable) side effects in each of the competing products, while not mentioning the sponsor's product at all. No sell-out here, just science, right? Not exactly.

The companies are not at all bashful about corrupting drug trials. There are lots of ways to do this: high doses of a comparator drug (in a trial comparing two drugs plus placebo). The patients on the comparator will have lots of side effects; the industry can suppress bad news in the trials because in a multi-center trial only the company has access to all the data.

In the hands of a clever editor, it is amazing how much bad news can be suppressed, and the trial—that found the drug basically useless—made to seem like a stunning success. (Those who want chapter-and-verse here should consult recent issues of the blog 1boringoldman.com).

At the moment there is no good way to break up this kind of industry cheating and this alliance with sell-out KOLs. The FDA, which has to approve drugs, sets the bar quite low (two successful trials, but you conducted 20, and 18 of them failed), side effects not too alarming. At least those reported were not too alarming.

The whole alliance between KOL-academics and the pharmaceutical industry has been corrupted, to the detriment of mental health. Useless, indeed dangerous drugs come onto the market; promising compounds are suppressed on the grounds of not being potential blockbusters; and the entire toxic stew means that science is abandoned in favor of commerce.

Hillary, do you want to make improvements in mental health? Better care for vets with PTSD is fine, but here are some real issues where you can make a real difference.

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