Letter to the head of the Drug Enforcement Administration, Demanding an End to Restrictions on Prescriptions of Stimulants to Children with ADHD

DEA Diversion Control Division
Attn: Liaison and Policy Section
8701 Morrissette Drive
Springfield, VA 22152

    RE: Prescribing of Stimulants in Children

Dear Madam or Sir,
I am requesting a waiver from your rules and oversight for doctors with child psychiatry training, for pediatricians, and for family doctors prescribing stimulants to children with attention deficit disorder, some with hyperactivity (ADHD), some without it (ADD). These rules include the prohibition of refills, the filling of scripts within days of their date, the limiting of post dated prescriptions to a total of three, oppressive tracking of prescribers, disruptive  harassment of legitimate prescribers.

Your statutory purpose is to reduce addiction in the United States. In the case of children and adolescents on stimulants, the majority must be forced to take them. Most resist doing so to avoid getting slowed down. Untreated ADHD is as silly, goofy, disruptive as any intoxication you care to name. They do not want to come down off this innate “high.”

This resistance to taking stimulants is despite tremendous resulting success, the ending of harassment for impulsive behavior, winning academic and conduct awards, the pressure of their families. The majority also have concomitant oppositional defiant disorder, where they engage in pointless opposition to adult instruction for no advantage to them. It comes as a package with ADHD.

This reaction and their features are the polar opposite of addiction. Your restrictions on these prescribers represent regulatory quackery. They violate the American with Disabilities Act Amendment, now covering mental conditions. They are against good policy by restricting access to care. They are cruel and stupid. Let me know your decision and any analysis by your legal counsel. If you decline this request, I will sue you in federal court for the above violations of law and of policy.

Hat Tip to Prof. Douglas Berman for information on this Hearing on Synthetic Drugs. Hat Tip to one of my Patients for the Insider Glimpse into this Massive Unexplored World of Synthetic Drugs.

The listing has links to submitted testimony. The hearing lost an opportunity to hear from the players in this world. That would have been far more edifying than the standard establishment cliches.

Difficult subject.

1) All substances and likely all remedies have a dose response curve. When diluted, the strongest poison on earth, botulinum toxin, has 753 medical benefits. When consumed too much, water causes seizures and death among dozens of healthy athletes. So, all claims of benefit or of harm should specify the dose, and provide a dose response curve. Judgment is therefore very difficult and requires data that is always missing.

2) Massive synthetic chemistry entrepreneurship is ongoing out there. Some of it has the potential to help people with medical problems, some normal people to enhance performance and to reduce risk, such as of car crashes from inattention or from sleepiness. It is not a simple utilitarian calculation.
3) Changing body functions is lucrative when reliable and effective, so could boost the economy, and tax revenues.

4) There is a massive grey and black market for these products, driven by consumer satisfaction with them. Chat rooms on alternative Internets, with lively intellectual discussions, ratings, and marketing of these synthetic products are really busy. The internet approach of ratings rather than prohibition or draconian regulation is likely far more effective. Compare nearly worthless contract law to disappointing an Ebay user and getting a low rating. The latter makes zero difference to our economy, the latter is devastating to a business. This grey territory is massive public self help alternative to the legal system, and 10 times more effective. It should be encouraged and brought out of shadows into the light. Doctors should get into it as a source of medical advances at nearly no cost. The legal system should get out of its way but tax it and promote consumer powers.

5) This do it yourself culture and territory is a threat to highly over regulated and very expensive pharmacology business. I would support shutting down the FDA, repealing all its enabling statutes. Let all out competition and ratings replace its worthless rent seeking with useful and safer methodology of drug regulation.

6) With all this synthetic chemistry talent in stir, Prison Industries should get into the drug making business, to make death penalty drugs which are a joke to make for these guys, following 19th Century recipes. Then instead of manufacturing prison clothes for $10, manufacture generic and synthetic drugs for $100 or $1000 a batch. Do it responsibly, and put the profits into improving the lives of the prisoners and into compensating their victims.

Did any of the speakers convey this level of complexity, and this great potential for both harm and benefit?

DEA to Chronic Pain Patients: Suffer.

But the paper work always comes first. I would like to see organized medicine protect clinical care from these heartless lawyers setting sick DEA managing pain and interfering with care. They should join in a massive class action lawsuit, with a Section 1983 claim against the DEA. First, the DEA should be enjoined from enforcing its arbitrary and lawyerized rules. Second, the DEA should be made to pay for the damages in pain caused by their arbitrary delay. To deter. 

A Battle Against Prescription Drugs Causes Pain

By JOHN LELAND

Roland Lorenz has surgical screws in his back and neck and a pin in his upper leg, and when his pain reared up one recent weekend, he knew he needed something strong. He had just been to a pain clinic, where the doctor ordered an increase in his dosage of Percocet, a narcotic.
It took two days to get the painkiller.
Mr. Lorenz, 75, lives in a nursing home in St. Louis. Until recently, the nurses would have sent an order to the pharmacy for the Percocet, based on instructions phoned in from the clinic — a longstanding practice for nursing homes, which typically do not have a full-time doctor on staff.
But now that practice has come under the scrutiny of the Drug Enforcement Administration. Last November, the pharmacy serving Mr. Lorenz’s nursing home announced that it would no longer dispense certain narcotics without a written or faxed prescription from a doctor.
For Mr. Lorenz, this meant a weekend of pain. The doctor at the pain clinic was not available, and the nursing home’s doctor on call would not write a prescription without examining Mr. Lorenz in person. For the next two days, Mr. Lorenz said, “I was miserable. I needed it to get straightened out. It was killing me.”
Staff members assured him that the drug was on its way at least six or seven times, said Mr. Lorenz, a former Marine and police officer.
“It’ll be there by midnight. It’ll be there by 2 a.m. The pharmacist kept saying he needed to talk to the doctor. It was real, real rough.”
Nursing homes and doctors say patients like Mr. Lorenz have become unintended casualties in the war on drugs because of a new level of enforcement intended to prevent narcotics from getting into the wrong hands. About 1.4 million Americans live in nursing homes.
The D.E.A. is investigating pharmacists in “about five states” for dispensing the drugs to nursing homes without direct written orders from a doctor, said Gary L. Boggs, an executive assistant in the agency’s Office of Diversion Control.
Earlier this year, the Senate’s Special Committee on Aging heard testimony from long-term-care professionals describing delays in delivering pain medications to patients. Two Democratic committee members, Senators Herb Kohl of Wisconsin and Sheldon Whitehouse of Rhode Island, have urged Attorney General Eric H. Holder Jr. to find a solution.
“We keep hearing the right things from the D.E.A. on this issue, but we haven’t seen any action,” Mr. Kohl said through an aide.
Mr. Boggs said the agency was just trying to protect patients. “This isn’t a matter of us being bureaucratic pencil pushers,” he said. “What we see is nurses unilaterally calling in prescriptions, or pharmacists dispensing controlled substances without a prescription, then trying to get a doctor to sign a prescription for a patient he never saw.”
In the meantime, doctors say, their patients suffer — sometimes for half an hour, sometimes for several days.
“There’s just a lot of potential for error in the process,” said Dr. Jonathan Musher, a geriatrician and past president of the American Medical Directors Association, a trade group of long-term-care doctors and administrators, which has sought a change in the requirements.
The problems are most common when patients first arrive at nursing homes from hospitals, Dr. Musher said.
For example, he recently had a patient move to a nursing home after a hip fracture. At the time, she was not on narcotic pain medication. That night the nurse called Dr. Musher to say that the woman was in pain. “I was told I had to call the pharmacist,” he said. “O.K., what’s the pharmacist’s number? The nurse has to call me back, she wasn’t sure. I get a call back with the number. I call the 800 number and leave a message. I get a call back a half hour later.
“So now there’s been a 45-minute delay. Now he tells me I have to fax in a prescription. I’m not home, so I say I will do it in 15 minutes. After I fax it, I call the nursing home, and they haven’t heard anything from the pharmacist. Finally I told them to send the patient to the hospital.”
She got her medication, “but that’s something we don’t want to do,” Dr. Musher said. “There are health issues with transfer, as well as the costs of transfer.”
Critics of the nursing home industry say the bigger problem is that facilities are not providing adequate medical care to their patients.

DOJ Responds to Freedom of Information Act Request for Suboxone Inspection Material

Looking forward to receiving it in electronic form, not in the form of a massive amount of paper.

DEA Opens Campaign to Intimidate and Deter Doctors Prescribing Buprenorphine (Suboxone), Then Hypocritically Plays Innocent

The real reason for this campaign?

The Congress wanted more buprenorphine used. The DEA does not want this expensive, brand name medication used in poorer, dark skinned patients. They want the latter on cheap methadone. Even the inspectors may have no awareness of the real motivation.

Doctors feel intimidated. There is an infinite number of deficiencies to be found in every record on earth. There is no evidence that record keeping correlates with quality of care, with patient outcomes, with the prevention of diversion, with fewer overdose deaths.

I filed Freedom of Information Act requests for all buprenorphine related training materials, communications and policy discussions.