provided the authority for us to audit the books of all firms, not only manufacturers but wholesalers. We are also required to check pharmacies. Now, that is a tremendous undertaking. There are 55,000 pharmacies in the U.S.A. alone and, to audit their recordkeeping practices, we have asked the States to assist us and we have effected contracts with 18 States to date to have the State board of pharmacies audit prescription practices, the recordkeeping practices of local pharmacies. So the program is proceeding and we think the main thrust of it is at those who divert, illegally produce, or legally produce and supply to those who are not in the normal channels of distribution these drugs that can be abused.

Mr. GROSSMAN. Dr. Goddard, getting back to your purported comments, I am particularly concerned about this marihuana question. I wonder if I could read to you from the task force report on drug abuse from the President's Commission on Law Enforcement and Administration of Justice. It says:

The inadequate data available today—

on marihuana—

indicate that risk of crime, accidents, and suicide... are not likely to be greater than those associated with alcohol and may be less. If the equivalence between alcohol and marijuana is to be accepted as the operating assumption until more facts are at hand-and we think that is a prudent position to take it follows that a public debate is in order with regard to the best regulation of marijuana.

Would you care to comment on that?

Dr. GODDARD. Well, I have commented a number of times as to the dangers of comparing these two. They are different drugs. One is a depressant, by and large. The other, marihuana, is primarily a hullucinogen, although it does have certain depressing properties depending on the dosage level and the individual availability. Now, I hestitate to draw these comparisons, but I am asked to do so. So I say, well, it's dangerous for people under the influence of alcohol or marihuana to operate heavy equipment or drive a vehicle. The latter distorts your perception of time and the former dulls your ability to handle this heavy equipment, which calls for fine coordination at low speeds. Even beyond that there are certain circumstances under which a drug is used, whether it be alcohol or marihuana, the amount one consumes, the amount one drinks or smokes, the personality of a user is a factor. The user's previous experience with either alcohol or marihuana is important. The inexperienced drinker does not know the signs and can go too far, just as, I am told, the inexperienced user of marihuana can go too far and get into a panic state. Now, these are some of the comparisons that can be made between these two.

If you are talking about comparisons with respect to a health problem, I think there is no question we have more clearly defined the health problem that exists with respect to alcohol: 11,000 deaths a year attributed to cirrhosis; the fatalities that occur as a result of highway accidents caused by people who have ingested too freely, the number of estimated alcoholics in our society-four and a half to five million; the number of heavy drinkers, that many more again, another four and a half or five million. There are approximately 70 million users of alcohol in society. We know the social costs in gross terms of alcohol. We do not have these kinds of data for marihuana.

I can give you a reference if you wish, a more precise pharmacological description of these drugs that are misused in our society. But those are the general comparisons I would draw.

Mr. GROSSMAN. As far as you are concerned, is there any social or medical value for marihuana?

Dr. GODDARD. I certainly know of no medical value at the present time. As I have mentioned before, the recent synthesis of the most active ingredient of marihuana, the tetraphdrocanabenols-THC-is rather interesting. The pharmacologists familiar with this have indicated that it may be helpful to have some of these data available with the mechanism of sleep, possibly the study of euphoria, as a mild euphoriant, the active ingredient may have some merit. So I would not preclude or close the door to the possibility of some useful pharmaceutical agent being developed from one of the synthetic things. But there is no medical purpose in our society for marihuana today and for practical purposes, there has not been since 1937. Now, social, it is hard to comment on, because it apparently does have some social use. People are using it quite widely.

Mr. GROSSMAN. In your testimony you discuss the inconsistencies between the laws relating to LSD and to marihuana. Have you specifically recommended to Congress any changes in the laws relating to marihuana?

Dr. GODDARD. No, sir; I am suggesting that they examine them. I have not, for example, recommended the removal of penalties for personal possession. I am not talking now about possession for sale, but personal possession. I am saying let's look at them. It may be executive seizure is indicated here. There is a whole spectrum of penalties one could consider. I am saying, look, the usage seems to be increasing. The major complaint we hear is about the inconsistency of the penalties and the question keeps coming up, time and time again. I am simply saying, is it not desirable to reexamine it?

Mr. GROSSMAN. Do you feel at all inhibited, perhaps, by law enforcement problems? For example, in this task force report, there is another statement which says:

In any event, it must be recognized that if the law does outlaw sale, but does not allow arrest for possession, whether this be for LSD, marihuana or any other drug, the work of the police will be long and hard and the public must not expect large numbers of arrests. As a corollary it is quite possible that such a policy would, as many law enforcement persons might fear, result in less suppression of illicit drug traffic and subsequent greater use.

Now, my question is, basically, do you feel that you have one point of view and that the law enforcement people are pushing against your making any changes in these laws?

Dr. GODDARD. Well, reading under the drug abuse control amendments, where we do not have a Federal penalty for personal possession but we do have the privilege of executive seizure, we have not found this to be a handicap. Our position has been that we want to concentrate our efforts on the sellers, the manufacturers, the distributors. Now, we do not condone the possession of LSD and these drugs, nor would I condone the possession of marihuana. It should be seized and taken away. I want to make that clear. Certainly there is room for discussion on this point as to how effective and how needed is the personal possession thing.

No, in our society, if we have these young people who are, for whatever their reason, flaunting the law, this is symptomatic of something deeper. Do we not need to examine what the underlying cause is and get at those problems?

We are also concerned about the turning point in people's lives. Let me explain that by saying, if you have a 17-year-old who has never been arrested, has no record, and is suddenly arrested for possession of drugs, whatever it may be, he then can have a criminal record. He then can be thrown into close association with others who have already committed themselves to a certain way of life. This may be the turning point in this person's life. What I think our department is concerned with is these people. We see the social cost as a very great one. We are trying to say, let us at all points along the line constantly reexamine what it is we are doing to people.

Mr. GROSSMAN. That is my point. Do you feel that, all the way along, you have enough influence with the police and the investigative authorities and that your point of view is put across?

Dr. GODDARD. Well, we are trying in our educational program and seminars directed toward local and State enforcement agencies to find them a broad understanding of the sociological phenomenon. Now, we certainly are not soft on enforcement. I must say I find it anomalous even to be accused in editorials of being a soft enforcer of the Food, Drug, and Cosmetic Act, because most have accused me of being quite the opposite in the past year and a half.

We think our bureau of drug abuse control has been a hard-hitting group. But the emphasis has been somewhat different, primarily on the trafficker. That is where we think we have to place our emphasis. Mr. GROSSMAN. If I may, just one further question on another area, with regard to LSD.

Following, I think, your testimony in 1966 before the Government Operations Committee, there were some problems with the loopholes, you might say, in the law or in your regulations. I would like to ask you-this is something from one of the committee reports in 1966"it would appear possible for the amateur chemist and even the qualified inventor or the unqualified to manufacture the drug for personal use without filing any application with FDA. Such a person might argue that he qualifies as a bona fide experimenter in the absence of any standard qualifications for such an experimenter, that he manufactured the drug for personal use only and not for sale, delivery, or other disposition, and is not obligated to file an application with FDA. Moreover, it would appear that this category of person is not required to register with the FDA as a manufacturer under section 510." In other words, can I just go home to my little lab and take care of this without any problem?

Dr. GODDARD. I think you might have a few problems, even if you were a good chemist, because we have placed under control most of the precursors that would be used to manufacture LSD. This does not mean to say that LSD is not being manufactured. We are really still up against it. As fast as we get at one source of manufacture, it seems that another one springs up.

Mr. GROSSMAN. Where have you been finding these sources?
Dr. GODDARD. On the west coast, the east coast.

Mr. GROSSMAN. I mean not where, but by whom, particularly?

Dr. GODDARD. These are individuals who are skilled chemists, let us say, moonlighting.

Mr. GORDON. Commissioner, I notice you referred to the east coast and the west coast. How about the middle?

Dr. GODDARD. We have them in the Middle West, too. They are not devoid of skilled chemists.

Mr. GORDON. I have a couple of questions not related to marihuana but to the FDA.

Next week, some people are going to come to testify before our committee, and in one of the statements I found the following:

Quality firms are well organized to recall with precision-this deals with precision from all commercial channels-any particular lot of a suspected drug product at any time or to provide emergency advice as to where a particular drug product can be obtained when needed.

Now, we have had, in fact we put into the record, considerable information about recalls and I notice that the recovery, especially from the large companies, has been extremely small. For example, we listed a recall from Ayerst Laboratories of 15 million tablets, of which only 30 percent was recovered. Squibb had a recall of Mycostatin. Only 20 percent of the 18 million tablets was recovered. Here is one recalled with 10 percent recovered, another with only 7.9 percent recovered, yet another with only 4 percent recovered.

Now, would you comment on the statement I read in view of the material on recalls that we got from the FDA?

Dr. GODDARD. Let me point out that you want to be careful. A drug company that only recovered 10 percent, this does not necessarily reflect upon their effectiveness in a given recall, but it may more accurately reflect the time period that elapsed between the production and distribution of the drug and the identification of the problem that required the recall. You see what I am driving at?

Mr. GORDON. No.

Dr. GODDARD. If a drug were subpotent, let us say, and batch No. 2,452 was produced on January 5, 1967, and the subpotency was not discovered until September 10, 1967, most of that batch may have been used by the time the recall is identified as being necessary. So there are several things that operate here. One is the elapsed time. Two is the effectiveness of the firm in getting at the batches at the wholesalers and the retailers level. Now, they have control numbers on product. All companies are required to do this. So they do have a precise way of identifying the drug to those who are in the system.

Now, this does not mean that it is not a lot of effort. It is. The wholesalers in meeting with them have expressed their concern about the cost and the effort that they are put to in helping in these recalls, and the local pharmacist is as well. So effectiveness of recall is again a function of several things. You are hard put at times to know just how effective a recall may have been unless there has been a very short period of time between the date of production and its entrance into the system.

Mr. Goodrich may wish to elaborate on this.

Mr. GOODRICH. Simply to say that our good manufacturing practice regulations require that all companies have the capability of recalling from the market drugs that turn out to be subpotent or otherwise in violation. The mechanisms of action are applicable to all drugs. A

trade-name drug may have to be recalled just as rapidly as a generic name drug and vice versa. We hope that, we think we have the mechanism for getting the drug back off the market on signs of danger. Mr. GORDON. But the size of the company has nothing to do with the efficiency of recall, then?

Dr. GODDARD. Nothing. They may have a more expensive computer system that will turn out the identification of the invoices, but we require that all companies, large and small, have that capability.

Senator NELSON. From your experience with recalls, do you find any significant difference between the efficiency and the effectiveness of the recall between or among the various companies?

Dr. GODDARD. We find differences; yes.

But we insist that, depending upon the nature of the hazard that calls for the recall, that steps be taken to get the drug back in the most expeditious way. If it happens to be a small firm that cannot do the job, then we have to use our own resources to get it back. But we do have, as I have said, under our requirements for good manufacturing practice, a provision to require this capability.

Senator NELSON. You mean that if a company does not have the capability, FDA will do it for them?

Dr. GODDARD. We had an instance, Senator, in which a company put on the market a-it was not a drug, but a highly flammable, explosive waterproof compound, "X-33". It was necessary that that come off the market and come off the market promptly. The company did not have the money or the ability to get the product back, so we had to make hundreds of seizures throughout the United States in the interest of lifesaving from accidents that could have occurred. Now, the same could happen with a drug. But we expect to have as a part of our good manufacturing requirements a provision that before a person can deal in drugs, he will have the capability of getting the product back, which does not mean that Food and Drug will never be called on to use its facilities. We frequently are.

Senator NELSON. Do you find differences in either frequency or efficiency on the recalls based upon the size of the company?

In other words, the point I am getting at here is whether small companies are less effective than big ones?

Dr. GODDARD. In general, the larger the company, the more responsesthey can afford and have available to devote to the problem; yes. So there are differences.

Do not forget, we have a well-defined system in which these takeplace, namely, the pharmaceutical wholesalers and the retailers, the drug store. These are well identified, whereas if you are dealing with other commercial products such as a solvent or a cleaner, it may be in a host of outlets of different kinds. So you have a much tougherproblem.

We had an oven cleaner recently that posed a threat. It was very difficult. The effectiveness of that company's recall-and we worked with them on this was at a very low level because of the diversity of the kinds of outlets, you see. So the drug business is truly unique in many respects, and this is one of them.

Senator NELSON. A few moments ago, you were discussing LSD and marihuana. I understood you to say that they are used socially; there

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