A State of Wisconsin drug researcher was casually looking over some computer data he had requested from the U.S. Drug Enforcement Administration when he began to notice some strange patterns in the sale of amphetamines.
Looking over the 1975 sales figures for a drug called Biphetamine 20, manufactured by the spennwalt Co., and known on the street as "Black Cadillacs" or "Black Beauties," Wisconsin Controlled Substances Board staffer David Joranson saw some startling statistics.
The discovery has led to a state law banning the use of amphetamines for anything but certain accepted medical applications of amphetamines are the treatment of narcolepsy (uncontrollable sleeping), hyperkinesis, brain disfunctions and certain psychiatric ailments. The ban is one of the first of its kind in the nation and went into effect last week.
But perhaps even more important, the state ban may have another role in the overall picture of drug regulation around the nation. On Dec. 2, the Food and Drug Administration will begin hearings on amphetamines, and FDA officials say the testimony of Wisconsin officials should go a long way toward aiding the development of stronger federal sanctions on the use of speed.
Of approximately 1 million doses of Biphetamine 20 sold in 1975 in Wisconsin, more than 118,000 were dispensed by only 26 practitioners, the federal figures revealed to Joranson. And while 20 of those practitioners were physicians, 3 were osteopaths, 2 were dentists, and 1 was a podiatrist. The 6 non-physicians were responsible for more than 20,000 dosage units being dispensed.
Considering the fact that there are more than 6,000 physicians alone in Wisconsin, the high concentration of sales in such a small portion of the medical community seemed suspicious to Joranson, a former social worker who developed a drug abuse program while he was at the University of Wisconsin in Madison getting his master's degree.
"We couldn't believe those figures," Joranson said in an interview. "And we knew we had to do something about it."
One doctor alone had purchased more 33,000 pills, while a second was responsible for 28,000 and a third for 8,200, the study revealed. Then there was a significant drop in the amounts purchased by the remaining practitioners.
Another surprising figure revealed that almost half of the 118,000 pills sold by the top 26 were sold in Milwaukee County, while an equal number were sold in sparsely populated Dodge County, which has a large German community, a state prison, "and probably a lot of fat women," according to Joranson.
The odd patterns of distribution of amphetamines around the state were not caused by medical quirks, Joranson said. "Basically, practitioners had found a way of making a lot of money."
So Joranson began a more intensive study to establish the patterns for sale of all emphetamines around the state. More federal computer data was summoned. And in discussions with the state police, Joranson learned that most of the amphetamines sold throughout the state were of the prescription-type that had to come through traditional medical channels.
Then Joranson scheduled a symposium in Madison for last June in order to release his new data and to announce that the state Department of Health & Social Services, in response to Joranson's first report, no longer would allow amphetamine products to be paid for under Medicaid.
"It became pretty clear that many of those Milwaukee doctors were prescribing large doses of amphetamines to Mediciad recipients," Joranson said. "And sales of Bifetamine 20 dropped off precipitously right after the Medicaid funding was cut off."
The average sale of amphetamines by the big drug distributors in Wisconsin was about 25,000 dosage units per month until the Medicaid cutoff, Joranson said. After the cutoff, sales dropped to 2,200 a month. Although they have come back up to the 10,000 range for unknown reasons, there has been a leveling in the past few months.
At the June symposium, high-level representatives of several state agencies, including the Attorney General's office, Justice Department, Pharmeceutical Examination Board, Medical Examination Board, State Medical Society, and others, gathered to discuss the findings of Joranson's study, and to hear the results of his second study.
"We found in the second study that Bifetamine 20 wasn't the biggest seller in the amphetamine field," Joranson said. "Dexedrine was selling even more, and Benzedrine (settle back and let 'Benny' do the driving, goes the old truckers' tale) and Desoxyn were also big sellers."
In a startling development, the second study revealed that six pharmacies in small Sheboygan county had purchased more than 5,000 units each in 1976, for a total of 56,000 units. When that information was released, the local newsaper, the Sheboygan Press, had banner headlines exclaiming: "Sheboygan: State Speed Capital."
"The day after that story appeared, we found out that all of those pills were being prescribed by one doctor up there, and after seeing the headlines he stopped prescribing them for good," Joranson remembers. "The pharmacies up there were in a mad scramble to unload all the pills they had in stock back to the drug companies last I heard."
It was also at the symposium that Irving Ansfield of the Medical Examiners Board stated the board's intention of issuing an administrative rule that would accuse a doctor of "unprofessional conduct" if he or she prescribed amphetamines for weight control.
The Medical Examiners' Board ruling had a chilling effect: The board is the only group sanctioned to remove the license of a doctor practicing in that state - even the FDA does not have that power - and the board said it would enforce this rule. That rule eventually was passed and went into effect the first of this month.
"Really," says Joranson, "the rule is a message to the federal government to support us, and compliment this kind of activity. We are dealing with doctors who are making a living on this sort of thing, and lightweight regulations are just not enough."
"We see ourselves at the vanguard of getting the other states and the federal government to look at this problem," Joranson says. "To see that there are other just as serious problems besides Schedule One drugs like heroin. These other drugs, like amphetamines, which are used regularly can pose a greater problem because of their availability."
It appears that the federal government agrees strongly with Joranson, and is anxious to hear his testimony next month.
"When we found out what was going on in Wisconsin, it was a pleasant surprise," says FDA official Stuart Nightingale, who is putting together the upcoming hearings. "Only the states have the power to take away a doctor's license or take other disciplinary action. We can't stop a physician, but we can take other actions that are consistent with what has happened in Wisconsin."
"What they have is the power to move further than the federal government," Nightingale said. "We think it's a good idea for a state-level action like this to take place. It is much more effective than what we can do."
But Nightingale said his hearings are aimed at getting the FDA to propose labeling changes on the amphetamines that are sold. He pointed out that the rule passed in Wisconsin - and similer restrictions in Maryland - will be highlighted by the hearings.
In Maryland, the state medical society five years ago passed a ruling similer to Wisconsin's, but dealing with a smaller group of drugs. While the Wisconsin rule covers hundreds of different drugs, the Maryland regulation deals with only hard-core amphetamines. And the only two medical applications acceptable in Maryland, with certain special exceptions, are hyperkinesis and narcolepsy.
After Maryland instituted its regulation, and after every doctor had to report every time he prescribed an amphetamine - even for legitimate reasons - "we began to see a sharp decline in the use of amphetamines throughout the state," said Dr. Ken Yaffe, chairman of the Maryland drug abuse subcommittee of the state medical society.
"This hearing is going to act as a showcase for how the best states have approached the problem of abuse," FDA's Nightingale said.
The FDA regulations can also affect how many doses of any particular drug are sold. According to Nightingale, the FDA, through the Justice Department, already has a national quota for the number of amphetamines that can be produced and sold here, "but the quota has apparently not reduced the problems of abuse."
There are also indications that the administration will support FDA efforts to further control abuse of certain drugs like amphetamines. In his August address to Congress, President Carter said:
"I am recommending a conscious and deliberate increase in attention throughout the federal government to the problems related to the abuse of drugs that come originally from legitimate medical sources."
He also called for "a concerted drive," by the Attorney General and state authorities to identify and prosecute physicians who overprescribe "a wide variety of drugs."
Wisconsin officials hope their message at the hearings will be heard.
"A large number of states don't even know what information is available to them," said Joranson. "If they know what is available, they will ask for it and use the information."
Pointing out that the states have the responsibility to monitor such activities, Joranson said there is a need "to re-evaluate the role of the states in monitoring the retail distribution of controlled drugs. There is a definite need for additional legislation, or a revision of the uniformed controlled substances act that many states have adopted."
The fact that many states are unsure of their role in drug regulation, and unaware of the data available to them, only creates a situation "that serves to shield overprescribing doctors and legal pushers," Joranson said.
According to Deanna Zychowski, executive secretary of the Wisconsin State Medical Examiners' Board, there were no protesters when the ban was proposed and public hearings held.
"But we have heard from a few drug companies who think we may have made the ban too broad, and should exclude some of the milder drugs they produce," she said.
Zychowski says that the board fully intends to follow up on its threat to revoke the license of any physician found abusing the use of certain drugs. She said new provisions in the state Medical Practices Act, revised a year ago, gave the board the broadened powers it needed to crack down on physicians who the board feels are acting unprofessionally.
"The one thing I would like to stress," Zychowski said, "is that this is not a problem unique to Wisconsin. We hope we can cause some action on the federal level. We have already talked with many states who are planning to take similer actions."