Narcotics research, rehabilitation, and treatment. Hearings, Ninety ...

'402How many would you say are being treated with other drugs?Dr. Gardner. At this point in time, a very small number. Theonly other drugs that are really being studied A\dth any kind of intensityare the derivative of methadone, acetyl-methadol, and some blockingagents as Dr. Edwards mentioned, cyclazocine and naloxone. Thestudies involving cyclazocine and naloxone do not include more thana few hundred patients.Chairman Pepper. So if there are 200,000 or 300,000 heroin addictsin the United States, your opinion is that probably less than 50,000are receiving treatment with some approved drug?Dr. Edwards. On some apjjroved drug, that is correct; j'^es.Chairman Pepper. Well, now. Doctor, I would like to have therecord show clearly what the function of the Food and Drug Administrationis. You are not charged with trying to solve the herohiproblem in the country, are you, in the sense of having responsibilityfor developing a drug that will block heroin addiction, heroin euphoria?Dr. Edwards. No; but we do have the responsibility of workingwith and encouraging research in this area.Chairma!! Pepper. Does your agency carry on any research ofits own in this field, to try to find a drug that would be a blockage orimmunizing drug?Dr. Edwards. No. We are not doing any immediate work ourselves.Chairman Pepper. That is what I was getthig at. You are notcharged with the responsibility by law of furnishing the funds to carryon independent research to try to find a drug that will be a blockageor an immunizing drug for heroin?Dr. Edwards. We are supplying funds to the Committee on DrugDe])endence.Chairman Pepper. You are more or less a policing agency toexamine drugs that are projiosed to you and to see whether or notafter projier inquiry is made, they are efficacious and/or safe drugs?Dr. Edwards. That is correct. Our responsibility is to evaluatethe scientific data obtained from these various programs and to evaluatethe safety and efficacy of the drugs.Chairman Pepper. And since submissions to your agency mightbe made by another Government agency, or almost anybody whowants to use a drug, private pharmaceuticals or NIMH, and tryingto carry on an inquiry, trying to develoji a particular type of dnig.Dr. Edwards. Yes, sir; that is correct.Chairman Pepper. Does NIMH in your opinion generallyhave responsibility in this field as the initiating agency to try and dosomething about the drug i)roblem?Dr. Edwards. I think it has the })rime responsibility in the FederalEstablishment for initiating and stimulating r(>search in this area;yes.Chairman Pepper. Well, now, has NIMH submitted to the Foodand Drug Administration any drug and asked for your evaluation ofthose di-ugs with res])ect to the treatment of heroin addiction?Dr. Edwards. For the specifics I would have to ask Dr. Gardnerto answer.Dr. Gardner. They submitted a|)plications for investigational newdrug status for not only methadone, but for some other drugs, particularl}^those that are being studied in the Lexington Research Center,