July 7, 1990

Dear Mr. Trebach:

My wife and I are having a terrible time obtain-ing methadone from the state of Vermont., even the neighboring states. We have recently asked nine Vermont physicians if they would apply for a license to dispense methadone to my wife and I. They all seem to be discouraged by the legislation and regulations associated with it.

At the present time we are being forced to drive into Harlem, New York every week to buy our medicine on the street. We are spending 50 cents on the dollar just to keep from being sick. Last week we bought some methadone not realizing it had been cut with clonidine and darvocet-n 100 because the color matches the disks when they are dissolved.

After nine years of reporting to methadone clinics for my daily medicine, I decided to try my hand at detoxification. So five months ago I checked into the well known McLean Hospital in Boston, Mass. I was shocked when I found out that a famous drug hospital like McLean was unable to locate another person who was on methadone maintenance for a few years, who was able to successfully detoxify (being clean for at least three years). In 30 days, my insurance ran out, so I came home from the hospital unable to eat, sleep, work, etc., etc. The physiological pain was so severe, and the treatment so ineffective for this drug, that I have been buying narcotics on the street ever since.

My inability to obtain our medicine legally has been conscience-shocking. Never in my wildest dreams did I think that sick people in America would be so inhumanely treated, forced to buy medicine on street corners.

Lastly, we are enclosing copies of some letters that began when we wrote to Dr. Ian McDonald, assistant to President Reagan. We would be very grateful if you could write something in the next Drug Policy Letter about this problem. Also would you or the Foundation know of an associate in the Vermont area that would consider treating my wife and I?

Thank you very kindly,

Lawrence K. Cushing

August 8, 1988

Dr. Ian McDonald The White House

Dear Dr. Ian McDonald:

I am writing this letter to you in an effort to seek medical relief. I have exhausted every local, state, and federal agency in an attempt to purchase medicine for myself, and my fiancee without success.

I have been chemically dependent on methadone hydrochloride for the past 7-8 years. I have never missed a day without taking my medicine. We are originally from the state of Massachusetts where our treatment on methadone started. However, we now live in the state of Vermont, and there are no doctors in the state licensed to treat people with a methadone dependency. As a result of this we are forced to drive from central Vermont to Manhattan, N.Y, every week to purchase our medicine from a private clinic at a cost of $150 a week. The trip is a 630-mile drive, so that means another $50 for gasoline and tolls. However, the doctor has been kind enough to let us drink one dose there and take six days' supply home with us.

Nevertheless, it's just not enough. We have been making this trip for about a year now, and as a result of the distance we have to drive every week, and the loss of time on my job I am financially, mentally and physically drained.

I feel that I am a responsible person. I am 39 years old with two teenage daughters. And my fiancee is 35 years of age with two teenage children of which we do our best to support. I have worked as a welder, building power plants for the past 20 years. However, we are dependent on this medicine every day of our life.

To charge this kind of money for a few dollars worth of medicine is clearly taking advantage of the law. This doctor knows that there are no doctors in Vermont that we can turn to. At the writing of this letter, we have fallen behind on all our bills, including our payment to the doctor in New York. He told us if we can't afford his fee, he can't treat us.

We would appreciate anything you could do in assisting us to obtain our medicine more locally.

Thank you for your anticipated help with this medical problem.

Very Truly Yours,

Lawrence K. Cushing

Alcohol, Drug Abuse and Mental Health Administration
Rockville, Maryland 20857

September 19, 1988

Dear Mr. Cushing:

I am responding to your letter, dated Aug. 8, 1988, to Dr. Donald Ian MacDonald, Deputy Assistant to the President and Director, Drug Abuse Policy Office. I apologize for the delay in responding.

I sympathize with the difficulties you are having as a result of traveling 630 miles a week in order to get the methadone you apparently need. Nevertheless, I think it is clear that the federal government is constrained by Federal regulations at 21 C.F.R. Part 291 from granting you relief at this time.

As you know, the Food and Drug Administra-tion is responsible under those regulations for overseeing methadone treatment to assure its appropriateness. The regulations stipulate that any federally-approved methadone treatment program must meet all state requirements. That stipulation is consistent with long-standing federal policy to leave the practice of medicine to states and professional societies.

I understand that Mr. Gerald R. Hajarian of the Food and Drug Administration has indicated to you that his agency would consider any request from a physician for approval to administer you methadone, including a request that would reduce the number of visits you needed to make to the physician's office.

As you may know, Massachusetts, unlike Vermont and other neighboring states, does have federally approved methadone programs available to out-of-staters. Mr. Lennie Kepsc, President, Habit Management, 648 Beacon St., Third Floor, Boston, Mass., 02215 has clinics that may permit you to take home a week's supply or more of methadone. One of those clinics is in Lowell, another is scheduled to open soon in Springfield. In order to ex-plore those options, please call Mr. Kupsc at (617) 267-3488.

If you want to explore other options in Massachusetts, please contact Mr. Paul J. Tierney, Manager, Licensing and Regulations, Division of Drug Rehabilitation, Commonwealth of Massachusetts, 150 Tremont St, Boston, Mass., 02111. Mr. Tierney also can be reached at (617) 727-1960.

Finally, please understand that federal regulations, including those at 21 C.F.R. Part 291, generally are published only after review of public comment on proposed rules. Thus, they cannot be changed without a lengthy formal process involving further public comment.

Sincerely yours,

Frederick K. Goodwin, M.D. Administrator

February 4, 1989

Frederick K. Goodwin, M.D.

Department of Health and Human Services Rockville, Maryland 20857

Dear Dr. Goodwin:

I am writing this letter in reference to your letter dated Sept. 19, 1989, regarding federal regu-lations that control methadone prescribing for the treatment of narcotic addiction. I apologize for my delay in responding, However, when I received your letter I was very pleased to find that someone in government is knowledgeable with this subject matter.

You state in your letter that the federal government is constrained by federal regulations at 21 C.F.R. part 291 from granting me relief at this time. I think it is clear for you to say that I am constrained from obtaining medial relief as a result of federal regulations that seem to be experimental in nature.

I am now into my ninth year of reporting to a doctor's office every day, seven days a week, for the first six years so that a nurse can put a pill into a plastic cup, and mix a little bit of hot water to it in order to dissolve the pill, and then allowing me to drink my medicine as if I were a five-year-old child. For this service, a doctor charges me $75 a week. The best part is if I don't have the money, I don't get my medicine.

I realize that these regulations create thousands of jobs for people that would probably have trouble obtaining a real job. These regulations turn the patient into a slave for the doctor that owns the clinic, and enslaves the patients to his entire staff.

If you read my previous letter you know that I am 39 years old, I have two daughters, the oldest being 19 years of age, and the younger is 14. I have always played a responsible role in society. When I lived in Massachusetts I worked as a real estate broker for 10 years selling and building hundreds of homes to many happy families. In addition to this I am an engineer. I am presently working in the Vermont Atomic Nuclear power plant as a machinery engineer with top security clearance allowing me to work on equipment as sensitive as a nuclear reactor. I am adding this in order to give you some knowledge of my employment background.

These regulations were put into effect back in 1971. Keep in mind, we had no AIDS problem at that time. Prior to this, a local physician was able to prescribe this medicine to anyone in need of treatment. However, these federal regulations controlling the distribution of methadone have complicated treatment so much that it is almost impossible to obtain, unless you live and work next door to a clinic.

You say in your letter that Mr. Lennie Kupsc may permit me to take home a week's supply of medicine. Do you realize that 20 years ago when a drug addict robbed a drug store, they would flush the methadone down the toilet, because it destroys the effect of a real narcotic? Now, because it is so difficult to obtain, it is being sold for more money than heroin on the street. The federal government has turned the one chemical that truly works for opiate addiction into another valuable substance by simply implementing 21 C.F.R. part 291.

When these regulations were put into effect in 1971, they never took into consideration that a patient may need this drug for 10, 20 or 30 years or maybe forever. These regulations are clearly experimental in nature. From most patients' point of view, these rules are cruel and unusual medical treatment.

Lastly, I can only request that you would be kind enough to furnish me with the name of the legislators responsible for constructing these rules so that I could write to them. Or the government branch that I could appeal to for exemption for these regulations. If I need to appeal to the Department of Justice would you give me some guidance in this direction. Also, how does one obtain a review of public comment on these rules, because I for one would want to be present at these formal hearings.

This is not a problem of drug abuse; I suffer from a chemical imbalance of which the only relief I get involves being dependent on dolophine hydrochloride. 'Without this medicine I suffer from chronic pain and depression.

Thank you for your anticipated cooperation,

Lawrence Cushing

Office of the Administrator

Alcohol, Drug Abuse and Mental Health AdministrationRockville, Maryland 20857

March 21, 1989

Dear Mr. Cushing:

Thank you for your letter dated Feb. 4, 1989. I apologize for the delay in responding.

I understand that after I wrote you on Sept. 19, 1988, you received a letter from Ms. Betty Jones of the Food and Drug Administration indicating that FDA has already provided you the assistance it can under methadone regulations published jointly by FDA and this Agency's National Institute on Drug Abuse (NIDA).

I regret that I cannot offer you any assistance beyond that which I have already offered regard-ing your specific problem with availability of methadone at a convenient location. If you have not already done so, you may want to take up the suggestion in my previous letter that you contact Mr. Lennie Kupsc in Boston. Mr. Kupsc had indicated a willingness to provide you methadone at various sites in Massachusetts that are closer to home than the one you indicated you are using.

As you may know, federal methadone regulations were published pursuant to the comprehensive Drug Abuse Prevention and Control Act of 1970 and the Narcotic Addict Treatment Act of 1974. An objective of these laws was to improve the quality of treatment by encouraging private physicians to treat narcotic addicts and to do so in an appropriate manner. Prior to 1970, there were relatively few physicians in the United States treating narcotic addicts because of confusion over the legality of dispensing addictive and potentially dangerous drugs. After 1970, diversion of methadone and other abuses prompted passage of the 1974 legislation. Thus, these two laws and implementing regulations were designed to provide a safe environment for the treatment of narcotic addicts.

Contrary to your assertion, these regulations are not experimental. Working closely with FDA, NIDA had established sound standards for treatment of narcotic addicts with methadone under the regulations.

FDA and NIDA may, from time to time, jointly publish revisions to the regulations. In fact, on March 2, 1989, they published in the Federal Register such a revision, extending from 21 to 128 days the maximum permitted detoxification period. However, the regulations continue to stipulate that narcotic treatment programs must meet all state requirements. Consistent with this stipulation, it is and always has been our policy to avoid interfering in the practice of medicine. Thus, FDA, which is responsible for compliance monitoring, would consider a request from a physician to reduce the frequency of visits you need to make in order to obtain methadone. We see no cause, however, for attempting to mandate that your state or any &her state provide methadone treatment, or for dictat-ing unnecessary operational details of such treatment

I continue to believe the regulations are fair and workable. You indicate that methadone treatment you have received under these regulations has enabled you to avoid chronic pain and depression. You further indicate that you are holding down an important and responsible job. I trust and hope that our regulations may have provided you some small assistance in what you have accomplished and that you continue to function successfully.

In response to your request on how to seek changes to the regulations, you may want to contact your local representatives in Congress. Finally, in response to your question on review of public comment on any regulatory change that is proposed, such comments are available for public inspection. In order to review comments on past or future NIDA/FDA methadone regulations, please contact Docket Management Branch HFA-305, Food and Drug Administration, Room 4-62, 5600 Fishers Lane, Rockville, Maryland 20857. In addition, you and other members of the public are free to comment on any proposed regulations. Proposed regulations are published daily in the Federal Register.

Sincerely yours,

Frederick K. Goodwin, M.D. Administrator

April 8, 1989

Dear Dr. Goodwin:

This letter is in response to your March 21, 1989, letter concerning methadone maintenance treatment.

Firstly, I want to say that the FDA has not provided any assistance to us whatsoever, other than the location of clinics that we are already aware of and have been for nine years.

Secondly, as for Mr. Lennie Kupsc, I was thrown off his clinic in Boston in 1987 without even the benefit of a detox. All because I asked the clinic if they would give me a one-week, take-home supply of medicine, so I could visit my family in Vermont. They refused after I had been in treatrnent for six years without any problems. Then, the director had the nerve to ask me how I felt about it? I was paying this clinic $80 a week, for $2 worth of pills.

Fortunately, a doctor took me in for treatment the very next day, in New York. Otherwise, I would be back out on the street.

Thirdly, as for holding down a responsible job, you have very much misrepresented my previous letter. I am forced to seek new employment every 60 days as a result of your strict methadone rules.

Fourthly, you state in your letter that it has always been your policy not to interfere in the practice of medicine. However, we both know that you would waste no time interfering if a doctor tried to truly help me by providing our family with a simple 30-day supply of medicine, would you not?

You also state in your letter that the methadone treatment I have received has enabled me to avoid chronic pain. Honestly, the underworld offers a more realistic treatment plan for less money.

As for this treatment being experimental, never in American history have we had a drug problem like we do under current federal policy. So let's just let nature take its course on the question of controls for desperately needed medicine. The only reason methadone patients are not flooding your office with letters is because 90 percent of them are forced to break the law to survive the bureaucracy.

Obviously all my efforts of writing to your office for help have been a total waste. Either you lack the desire, or you haven't the ability to pick up the phone and ask a Vermont physician to help me and my wife with methadone treatment, as it could only be achieved with the influence of your office.

I sincerely regret ever asking for help,

Lawrence Cushing