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METHAQUALONE: how drug companies profited

THE HISTORY OF LUDES:  A classic example of the supervisory body's failure to supervise a drug manufacture, and how this failure permitted millions in revenues.

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No college textbook on recreational drugs has come close to Drugs, Society, and Human Behavior.[1]  I was fortunate to have this as my textbook back in 1980 for a class interdisciplinary class on drugs.  I came to the class with extensive knowledge of the materials covered and so was quite qualified to evaluate this textbook.  I found scarce a statement for me to scribble in its margins overa thing I do habitually even over trifling. 


Since then I had checked several library collections and several university bookstores for their holdings and found them well below the standards of this book.  No gap between textbook have I ever observed so wide.  This explains its success, 3 editions, 300,000 copies, and used in more than 250 colleges and universities in the 11 years since its publication in 1972 (I got a second copy from a used bookstore).  Professor Oakley Ray has done well, and it is still in print!  Oh, and there is Audio Cassette and Audio CD versions.


I have included two pieces from the book, reversed their order.  The methaqualone section I put first because the purpose was to expose how drug companies for profits abuse their position.  However, I added as an afterthought, at the bottom the historical introduction on the first downers.  This book is simply good; it is hard for me to stop reading it again. 



Methaqualone. My daddy was right: If you miss a streetcar, dont worry, another one just like it will be along in a little while.  That seems also to be true of drug use crises.  Illegal use of methaqualone hit a peak in the early seventies and then declined.  From 1978 to 1979 it increased again and has per­sisted into the early 1980s.  New generations of drug users have to rediscover the wheel and see for themselves! In 1980 about 4 tons of methaqualone was made and distributed legally in the United States.  One guesstimate was that 100 million tons were smuggled in during that year.  And that must not be enough.  There may be honor among thieves, but there is none between an illegal drug producer and those who buy the product: there are an in­creasing number of tablets that look like legal methaqualone being sold on the street that contain OTC sedatives!  The legal but unethical distri­bution of methaqualone is under attack but difficult to stop.  Some believe the only step now is to make the drug Schedule Isince it really isnt a unique contribution to the therapeutic armamentarium.  Maybe we got ourselves into this mess because of sloppy thinking and action.


The methaqualone boom should make an inter­esting case study in future medical textbooks: How skillful public relations and advertising created a best sellerand helped cause a medical crisis in the process.[2]


The methaqualone story is one where every­one was wrongthe pharmaceutical industry, the FDA, the DEA, the press, the physicians.  No one can say he was without sin.  Methaqualone was orig­inally synthesized in India, tested, and found to be ineffective as an anti-malaria drug.  But it was a good sedative, so in 1959 it was introduced as a pre­scription drug in Great Britain.  It never sold well, but after the thalidomide disaster there was in­creased interest in a safe nonbarbiturate sleeping pill.  Mandrax, 250 mg methaqualone and 25 mg of an antihistamine, promised to be that when it was introduced in 1965 in a massive advertising cam­paign to physicians.  The campaign worked, and there were 2 million prescriptions issued for Man­drax in 1971 in Great Britain.  Even before that the drug had found its way into the street where it was widely abused: by heroin users, by high school students, by anyone who wanted a cheap but potent down.  Misuse was so great by 1968 that Great Britain tightened controls on it in 1979 and then again in 1973.  After that the methaqualone problems subsided as other drugs came to prominence. 


     Germany introduced methaqualone in 1960 as a nonprescription drug, had its first methaqualone suicide in 1962, and discovered that 10% to 22% of the drug overdoses treated in this period were a result of this drug.  In 1963 Germany reduced the problem by making methaqualone a prescription drug.  In this 1960-1964 period Japan experienced a major epidemic of methaqualone abuse, causing over 40% of all overdoses admitted to mental hos­pitals.  Japan tightened controls almost to the max­imum possible on methaqualone and stemmed the tide.  This happened even though they never took the final step of making it a prescription drug!


The same kinds of incidents followed around the world.  By 1965 both Germany and Japan had ex­perienced some very traumatic times with metha­qualone.  In 1965, after 3 years of testing, Quaalude and Sopors, brand names for methaqualone, were introduced in the United States as prescription drugs with the package insert, Addiction potential not established. Methaqualone was not a sched­uled drug: there were no monitoring rules or re­strictions on the number of times the prescription could be refilled.  In June 1966, the FDA Com­mittee on the Abuse Potential of Drugs decided that there was no need to monitor methaqualone, since there was no evidence of abuse potential! Thus, from 1967 to 1973, the package insert read, Physical dependence has not clearly been dem­onstrated, although by 1969 the evidence was very clear that methaqualone was an addicting drug.


In the early 1970s in this country, ludes and sopors (from Quaaludes and Sopors) were famil­iar terms in the drug culture and in drug treatment centers.  Physicians were over prescribing what they believed to be a drug that was safer than the bar­biturates as well as nonaddicting.  Most of the meth­aqualone sold on the street was legally manufac­tured and then either stolen or obtained through prescriptions.  At any rate, sales zoomed, and front-page reporting of its effects when misused helped build it as a drug of abuse.


Finally, 8 years after it was introduced into this country, 4 years after American scientists were say­ing it was addicting, 11 years after the first suicide, methaqualone was put on Schedule II October 4, 1973: quite a jump from not being scheduled to Schedule II.  Really stupid.  Maybe someday some­one will write a more comprehensive report on this tale of bureaucratic boondoggling, but the one pub­lished in 1975 by the Drug Abuse Council93 suffices for now.


 Addiction can develop to methaqualone as easily and rapidly as with the other barbiturates.  The high or down you get with methaqualone is very similar to that obtained with all other sedative-hypnotics.  There is, possibly, one difference: loss of motor coordination seems to be greater with this drug; the resulting loss of control, including walk­ing into walls, is why one of the slang terms for methaqualone is wallbanger. Methaqualone has had a better press than the other drugs in this class, and it was called heroin for lovers, an aphrodisiac.  Hardly.  As the director of Clinical Activities of the Haight-Ashbury Clinic[3] said in 1973:


What a drug to take.  It has all the possible dis­advantages a drug can have.  Its a garbage drug, a real drug of abuse.






As mentioned at the beginning of this chapter, Sedatives and hypnotics are both depressants of the central nervous system, but in one case the intention is to relieve anxiety or restlessness and in the other it is to induce sleep.  Many drugs may therefore be used in either capacity, depending upon the dose and the time of day that they are given.~ The most widely used drug in this general category is alcohol.  The second most commonly used depressant drugs are the barbiturates.



      There are three CNS depressants with a longer history than the barbiturates that are rarely prescribed today.  Chloral hydrate and paraldehyde have chemical and pharmacological characteristics much like alcohol, while the bromides are different.


     Chloral hydrate was synthesized in 1832 but was not used clinically until about 1870.  It is rapidly metabolized to trichioroethanol, which is the active hypnotic agent.  When taken orally, chloral hydrate has a short onset period (30 minutes), and 1 to 2 g will induce sleep in less than an hour.  This agent does not cause as much depression of the respi­ratory and cardiovascular systems as a comparable dose of the barbiturates and has fewer aftereffects.


In 1869 Dr. Benjamine Richardson introduced chloral hydrate to Great Britain. Ten years later he called it in one sense a beneficient, and in another sense a maleficient substance, I almost feel a regret that I took any part whatever in the introduction of the agent into the practice of healing.  He had learned that what man can misuse, some men will abuse.  As early as 1871 he referred to its non-therapeutic use as toxical luxury and lamented that chloral hydrate addicts had to be added to alcohol intemperants and opium-eaters.88 Chloral hydrate addiction is a tough way to go, since its major disadvantage is that it is a gastric irritant, and repeated use causes considerable stomach up­set. A solution of chloral hydrate was used before 1900 as the famous knockout drops or Mickey Finna few drops in a sailors drink, and before he woke up, he was shanghaied onto a boat at sea for a long trip to the Orient.


No such use ever occurred with paraldehyde, which was synthesized in 1829 and introduced clin­ically in 1882.  Paraldehyde would probably be in great use today because of its effectiveness as a CNS depressant with little respiratory depression and a wide safety margin, except for one characteristic.  It has a most noxious taste and odor that permeates the breath of the user.


The bromides are little used today, now that they have been removed from OTC sleep preparations.  Bromides accumulate in the body, and the depres­sion they cause builds up over several days of reg­ular use.  There are serious toxic effects with re­peated hypnotic doses of these agents.  Dermatitis and constipation are minor accompaniments; with increased intake, motor disturbances, delirium, and psychosis develop.






    A standard criticism of drug researchers who bioassay drugs is that they lose their objectivity.  That should be made of people of faith who translate works of their faith, of archaeologists who interpret finds, and of historians.  Only with science there is a long tradition of self-experimentation.  And usage of the drug, rather than being a hindrance (it can be if they have gotten caught up in its culture), can be quite insightful.


I have observed that the usage of stimulants (coke and amphetamines) rather has a short-term pleasurable dimension; it also has an equally compelling long-term vector; namely, the relief and prevention of boredom.  In fact I have observed that repeated usage of small amounts would produce this effect with producing the deleterious behavioral consequences.  I have known a number of people to use amphetamines in moderation for yearssupposedly for weight control. 





[1] Oakley Ray, Drugs, Society, & Human Behavior,  3rd Edition, C.V. Mosby Company, St. Louis, 1983, p. 312-314.

[2] Washington Post, November 12, 1972, p. B3.

[3]  Perry, C.:  Unconsciousness expansion:  the spoor story, Rolling Stone, P. 8, March 29, 1973.