CHAPTER ELEVEN
CONGRESS AND THE PILL MAKERS
TO REGULATE OR NOT TO REGULATE...

"All of us should be aware of one danger," the drugmaker warned Congress. "In the emotional atmosphere which surrounds drugs today, there will undoubtedly be pressure from some for hastily conceived action which could produce more harm than good. The Congress and the administration must be careful not to let the pendulum swing too far." The year was 1962. The drugmaker: Eugene N. Beesley, president of pharmaceutical giant Eli Lilly Co. The issue: how far the federal government should go to protect Americans from drugs. Addicts, it seems, aren't the only ones with drug habits. During the past 70 years, Congress and corporations have fallen into habitual patterns when it comes to the amphetamine family, swinging alternately between the need for public safety and the demands of free enterprise. Like many other drugs now feared and stigmatized, methamphetamine began as a scientist's triumph. Now associated with toothless speed freaks and Mexican mafioso, meth had its money-making start in esteemed U.S. corporations. Its abuse, moreover, continues to molt beyond the ability of lawmakers to erect defenses. Amphetamines first were marketed in the United States by the Smith Kline & French Co. (now Smith Kline Beecham) in 1932 in the form of an inhaler called Benzedrine. It proved a boom product, and during the next 15 years, nearly 40 uses for amphetamine were found. "A feeling of exhilaration and sense of well-being was a consistent effect, and patients volunteered that there had been a definite increase in mental activity and efficiency," raved the American Medical Association's Council on Pharmacy and Chemistry in 1937. But if doctors were discovering the potency of amphetamines, so were assorted hipsters, low-lifes, students and the curious. They learned they could remove the Benzedrine-soaked strips of paper inside the inhalers and get high. Each inhaler, by one study, contained the equivalent of 56 amphetamine tablets. By 1949, the problem was great enough the company withdrew the inhaler before the Food and Drug Administration required it. Two years later, the first congressional amphetamine regulatory measure, sponsored by Minnesota Sen. Hubert Humphrey, limited the use of barbiturates (downers) and amphetamines (uppers) to prescription. In 1955, a House subcommittee held 14 days of hearings on amphetamine and barbiturate abuse. Then, as now, horror stories inflamed lawmakers. California Superior Court Judge Twain Michelsen warned Congress in November 1955 that amphetamines were part of the larger Red Menace: "We know . . . that Communist China has an avowed purpose to destroy certain Western countries through the use of narcotics," Michelsen warned a House subcommittee. "Now we have the Communist narcotic invasion that is addressing itself to American and other Western civilizations. . . . I think we are right at the front door of Communist China's effort to despoil this country and other Western countries." Michelsen's warnings notwithstanding, top federal health officials during the 1950s considered amphetamines relatively benign. "Amphetamine is a stimulant drug," Dr. Halsey Hunt, the nation's assistant surgeon general, told the House Ways and Means Committee in 1955, "and as far as I know, it is not addicting in the true sense of the word." To this, the chief narcotics consultant to the National Institute on Mental Health, Dr. Kenneth Chapman, added: "Amphetamine  does not cause physiological dependence." He noted, moreover, that amphetamines had socially beneficial uses. For instance, Chapman recalled, "amphetamine drugs were used in wartime to permit pilots to get enough mental stimulation to get home after they had been through a series of bombing ." In fact, doctors were so unalarmed by amphetamine use that at one point in the 1960s, federal officials estimated that some 8 billion legally manufactured amphetamine and barbiturate tablets were in circulation in the United States. "The theme that pops out most is that physicians were the major agents for overuse of amphetamines," says Dr. Lester Grinspoon, a professor of psychiatry at Harvard Medical School. "Just a couple of decades ago, this was being prescribed by the ton load . . . physicians really believed it was like a panacea and that there was no downside." As the problems caused by meth and other amphetamines became more obvious, the House Ways and Means Committee began recommending tighter controls. It took several years, however, for Congress to act. And when it did, loopholes abounded. Though Smith Kline & French had voluntarily stopped selling its Benzedrine inhaler in 1949, other companies continued selling over-the-counter inhalers that included amphetamines. The Food and Drug Administration in 1959 issued rules banning amphetamines from inhalers -- but the FDA permitted methamphetamine to remain in inhaler use. In 1962, President John F. Kennedy's administration urged legislation that would require new drug testing procedures, warning labels, manufacturing safety and tighter control of stimulants. But the politically powerful American Medical Association, like the pharmaceutical companies, warned lawmakers not to let "emotions" guide their legislating. "We do not believe that the necessity for, or appropriateness of, additional federal legislation has been adequately demonstrated at this time," the AMA advised Congress. More study, the AMA said, should be undertaken. The doctors won the fight. "There was some initial resistance because I don't really think the pharmaceutical industry or chemical manufacturers really saw the magnitude of the problem, and they saw this as just restrictions on their commerce," says Bill Ruzzamenti, a Drug Enforcement Administration special agent based in Fresno. An example of that resistance came in the mid-1960s, when the Food and Drug Administration tried to survey legal amphetamine-producing companies. "Unfortunately," then-FDA Commissioner George Larrick lamented to a House committee in 1965, "our survey of production figures was incomplete because records kept by several basic manufacturers were grossly inadequate and also because two of the nation's largest pharmaceutical companies declined . . . to provide the information requested." By the late 1960s, however, the growth of a "speed freak" culture was catching lawmakers' eyes. Congress began imposing more restrictions on legal, prescribed amphetamines. And according to some estimates, up to half of the legal production was being diverted to the illegal market. Congress acted in 1970 with the Controlled Substances Act. Pharmaceutical companies had resisted parts of the law, warning that overly strict regulations simply would increase the amount of illegal production. Lawmakers, nonetheless, required new registration and accounting procedures for some substances, including amphetamines. The perennial tension between aggressive regulation and corporate interest ignited again in August 1996 when the Drug Enforcement Administration imposed tough new rules regulating over-the-counter sales of allergy and cold drugs. The DEA -- chasing, as always, after the latest innovation of illegal meth producers -- wanted to make it much harder for meth cooks to buy "precursor" chemicals, the key ingredients in meth making. The rules required retail drugstores to monitor and report on sales of the over-the-counter medicines containing pseudoephedrine. Any sale of more than 48 grams had to be reported -- and retail clerks who failed to do so could face a $25,000 fine and possible jail time. Drug companies howled. "This kind of regulatory approach is simply unworkable in today's retail marketplace," John Scheels, government affairs director for the drugstore chain Eckerd Corp., told a House panel in 1996. "That would ultimately cause us greatly increased costs, as it would to our customers." Drug companies urged Congress to scrap the rules and establish a "safe harbor" so cough and cold medicines could be sold in so-called blister packs without prompting paperwork requirements. Blister packs (individual pills have to be popped out one at a time) are believed to be less prone to mass abuse than bottled pills because it takes thousands of pills to make meth and cooks can simply slice the bottoms off bottles and dump them into the batch en masse. Pharmaceutical companies speak loudly on Capitol Hill. The top 10 companies and pharmaceutical trade associations spent $40 million lobbying Congress in 1998, according to reports by the Center for Responsive Politics; the industry's political action committees contributed an additional $5.1 million to federal candidates during the same year. Congress heard the corporate concerns. In an unusual step, as part of the 1996 Comprehensive Methamphetamine Control Act, lawmakers overturned the DEA rules. Congress established a "safe harbor" to allow easier sale of drugs such as Sudafed and Actifed in blister packs. "Make no mistake about it," said Sen. Orrin Hatch, the Utah Republican who chairs the Senate Judiciary Committee, "without the blister-pack provision, many legitimate distributors of over-the-counter products would likely choose not to offer ." Hatch received more than $250,000 from health and pharmaceutical company interests between 1995 and 1998, according to records compiled by the Center for Responsive Politics. Next to lawyers, the health and pharmaceutical companies were the biggest contributors to his campaigns. At the last minute, Congress also dropped plans to pile on mandatory minimum sentences as part of the 1996 meth law. "There is no evidence that such penalties will have any impact on reducing drug use," said Rep. Robert Scott, a Harvard-educated Virginia Democrat who sits on the House Judiciary Committee. "All of the studies I've seen show that mandatory minimum sentences are the least effective means of reducing crime. But they're an effective means of getting a politician re-elected." Instead, the law ordered the U.S. Sentencing Commission to review the wisdom of increasing meth-related prison sentences. The law, chasing after the new problem of mail-order chemical sales, also imposed reporting requirements for companies selling meth chemicals through the mail. But the 1996 law was barely in place before lawmakers tried to stiffen it. Indeed, a constant ratcheting up of sentences has been one persistent theme of the federal meth response. In 1986, there were no mandatory minimum sentences for meth offenses. Two years later, though, Congress set five- and 10-year minimum sentences. Ten grams of meth would trigger a five-year sentence. By 1998, Congress went tougher still: It would take only 5 grams to trigger a five-year sentence and 50 grams to impose 10 years. The public appeal of such efforts was exemplified in the name senators initially gave their current bill: the "Determined and Full Engagement Against the Threat of Methamphetamine" bill. Spelled out, this was supposed to read the "DEFEAT Meth" bill. The new measures have been championed by Western lawmakers such as Democratic Sen. Dianne Feinstein of California because of the drug's deep roots in the West. But as the problem has spread to the Midwest, lawmakers there have mobilized. This latest anti-meth effort resorts to both old and new tactics. Stiffer mandatory minimum sentences are included, continuing the trend. But a new twist worries civil libertarians. The original bill sought controls on what people talked about. For the first time, legislation would have made it illegal to communicate, "by any means," information pertaining to the manufacture of a controlled drug -- if the person either has the intent of breaking anti-drug laws or knows that the person receiving the information "intends to use the teaching, demonstration or information" for illegal purposes. The measure was in response to the proliferation of Internet sites that provide meth-making information. "Posting" or "linking to" these sites would have been made illegal. One version of the new meth bill has been folded into otherwise unrelated bankruptcy reform legislation. It orders the U.S. Sentencing Commission to stiffen meth-dealing penalties. It also allows funds seized from suspected criminals to be used to help clean up meth labs and orders the DEA to provide meth-related training to state officials. Some lawmakers also want to make it easier for meth-hunting police to search property without immediately notifying the property owner. House and Senate negotiators haven't resolved their differences over this bill, and its fate is uncertain. In late July, a House committee removed the provisions restricting the posting of drug-making information on the Web from one version of the legislation, but proponents vowed to get it back in. What is all but certain is that the meth wars will not end with the passage of new laws. If history is any judge, lawmakers will continue closing loopholes while lawbreakers will look for ways to stay ahead. "It's like a balloon," says U.S. Attorney Paul Seave, whose Sacramento-based Eastern District covers 34 counties and the heart of California's meth industry. "You squeeze the balloon in one place, and it bulges somewhere else. You squeeze it at the bulge, and it bulges in a new place." RELATED LINKS WHITE HOUSE DRUG POLICY NATIONAL INSTITUTE ON DRUG ABUSE DRUG ENFORCEMENT ADMINISTRATION       -back to top- -Chapter 12-