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The Dangerous Rebound of a Headache Drug

Jul 13, 1997 | ABC News

"You have to take the worst pain you've ever had," declares Dr. Katherine Fuller, "and imagine it doubled or tripled."

"The pain is like when you first get a traumatic injury," says Eric Phillips, "that first few seconds where you sprained the ankle, where you panicked because it hurt so much."

Nearly 25 million Americans suffer from the debilitating pain of migraine headaches. It can be excruciating, leaving sufferers desperate for relief. So when a painkiller called Stadol became available in an easy-to-use nasal spray, it provided many not only with relief, but with a sense of hope as well.

"First squirt I took," recalls Phillips, "my pain was completely gone. I thought, man, what a savior."

Stadol Nasal Spray, manufactured by Bristol-Myers Squibb, hit the market in 1992. It's a powerful drug, five times as potent at pain relief as morphine. At the time, the manufacturer told the U.S. Food and Drug Administration that Stadol had little of the addictive qualities of other narcotics.

Stadol, said Bristol-Myers Squibb, was a different kind of narcotic, "remarkably safe," with an "extremely low" potential for abuse. Their claims were backed by the FDA, which decided to allow doctors to prescribe Stadol without any government controls.

Only when one turns to the detailed language in the package insert for the nasal spray is there a warning. It reads: "Special care should be exercised in administering Stadol to emotionally unstable patients and to those with a history of drug misuse. When long-term therapy is necessary, such patients should be closely supervised."

"I tried honestly and very hard with the support of family around me that last month to get off of it and I couldn't," recalls Katherine Fuller, a Protestant minister from Michigan. Fuller required two hospitalizations to detoxify from the drug. To the many who have become addicted, getting off Stadol can be a nightmare.

Dr. Joel Saper has seen scores of patients addicted to Stadol. He's the director of the Michigan Head Pain and Neurological Institute and was one of the clinical investigators who studied the drug's effectiveness for Bristol-Myers Squibb. Saper conveyed his concerns about Stadol's addictive potential to the company nearly two years ago. He says he has yet to hear from them about a promised future study of the problem.

"We've seen people who have become so obsessive in their use of the medication that they would horde it," Saper says. "They would come with bottles in their suitcases and in their nightstands in the hospital, hiding it in various compartments."

He believes there is a place for drugs like Stadol, but he can't understand why it isn't carefully controlled like other powerful substances.

"Currently," Saper notes, "Stadol is being prescribed as any other drug that a doctor prescribes. Certainly, it's not being prescribed with the same cautions and prescriptions as we place on other narcotic and opioid medications."

Dr. Morris Fisher is a physician and professor of neurology at Loyola University in Chicago. He finds himself in the unlikely role of investigator, trying to find answers to questions about Stadol, not out of professional curiosity, but for deeply personal reasons.

"It's clear that using the drug was a problem," Fisher says, referring to his 24-year-old son, Bruce. "And it was clear that he had to get off it."

When Bruce came home to Evanston, Ill., for the summer after his first year of law school, he was having difficulty coping with migraines and had become heavily dependent on Stadol.

"It became clear we had even more of a problem than we thought," Fisher says. "He had really almost become nonfunctioning. And I think what happened there was just a moment of despair. I think he just gave up."

Bruce Fisher, although undergoing a supervised program of withdrawal, killed himself one August night in 1995, by placing a loaded shotgun in his mouth and pulling the trigger. It's impossible to know exactly why Bruce took his own life. But Fisher believes his son's addiction to Stadol —a $10,000 a year habit in the end —ultimately destroyed him.

A few weeks before Bruce died, Morris Fisher had called Bristol-Myers Squibb seeking help.

"I was really quite distraught," he remembers. "My son was in trouble, and I wasn't sure what to do about it, and I was looking for some advice. I spoke to a woman and basically she said my son was not addicted because he was not taking one or two vials a day."

Bristol-Myers Squibb refused to be interviewed for this report after initially agreeing to do so. It did provide us with a statement, which reads in part:

"Stadol Nasal Spray is an effective and well-tolerated pain relief medication … most patients who are prescribed Stadol Nasal Spray will not misuse or abuse the product. However, in some patients, misuse or abuse may become an issue. The medical community can minimize the risk of abuse with proper patient selection, prescribing limitations, and appropriate patient instructions."

Fisher and his wife, Natalie, contend their son was neither emotionally unstable nor had any history of drug misuse.

Recent advances in the study of migraine are driving intense competition among drug companies for the more than $2 billion spent annually by migraine sufferers. Last year, Stadol Nasal Spray hit nearly $140 million in sales in the United States alone.

Dr. Fred Sheftell is a headache specialist and adviser to Bristol-Myers Squibb about Stadol. It is his business to know how powerful a drug Stadol is.

"One spray of Stadol," explains Dr. Sheftell, "is equivalent to 37.5 milligrams of (the narcotic) Demerol. If that's not enough to alert anybody to the potency of the medication, I don't know what is. So you can't prescribe Stadol like water. Do I believe that this should be controlled? Absolutely."

But Stadol is not a controlled substance, and it's precisely because it isn't that most doctors are unaware of its dangers.

When a drug is scheduled—or classified as a controlled substance—by the government, it serves as a red flag to doctors, pharmacists and patients to be on guard about its addictive potential.

"Unscheduled drugs mean fewer controls on the pharmacist, fewer controls on the physician," says Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "A drug is much more likely to be a big seller or winner as a result."

When Fisher decided to find out why Stadol hit the market without any controls, he had to go back nearly 20 years, to 1978, when the FDA initially reviewed Stadol. The drug was then to be used in an injectable form, mainly in hospitals and typically for postoperative pain.

Fisher was surprised to find that the FDA's own advisory committee had voted overwhelmingly—12 to 2—to schedule the drug as a controlled substance. But in an unusual step, the FDA disregarded the advice of its own committee and allowed Stadol to be marketed as an unscheduled drug. (The FDA declined to be interviewed for this story.)

Some 12 years later, in December 1991, Bristol-Myers Squibb won FDA approval to sell Stadol in a new, much more accessible form: a nasal spray.

The company's application to the FDA stated that the nasal spray was not be used chronically—for a prolonged period. But it immediately began to market it aggressively for migraines, which are frequently a chronic condition, requiring repetitive use. For many migraines sufferers, the drug did provide relief, and sales began to soar, jumping 600 percent from 1992 to 1995.

"One Monday in 1992," recalls Dr. Larry Robbins, "it was horrific. We had patients calling, saying, 'Will you prescribe this Stadol? I read that it was a miracle for migraines.' "

Robbins remembers a "media blitz" in the Chicago area about the drug. He was concerned about high levels of adverse reactions he observed in patients using the nasal spray. But what most worried Robbins were the drug representatives from Bristol-Myers Squibb.

"The reps were coming in and saying that we could use it every half hour, one or two sprays, up to 18 sprays in a day," he says. "Eighteen sprays of this stuff would be enough to knock an elephant over. One or two sprays is a very big dose."

Robbins called Bristol-Myers Squibb about his concerns, and he wrote about them back in early 1993, calling for an investigation in the journal Headache. He says the company's drug reps stressed one thing above all.

"They emphasized that this drug is not regulated by the states and scheduled," he says, "which means to physicians, it's easier to prescribe. They were saying, basically, since the FDA decided not to schedule this drug, it must be safe and it must be relatively non-addicting."

But FDA documents indicate that within three years of the drug's release, there were reports of "widespread, significant abuse." Still, the FDA took no federal action to control the sale of Stadol.

Concern about the drug's addictive potential led pharmacist Drexel Douglas and his colleagues on the New Mexico Board of Pharmacy to act on their own, voting to control Stadol at the state level.

Bristol-Myers Squibb campaigned to fight controls sought by state authorities. In New Mexico, the company convinced the Board of Pharmacy to reconsider their earlier decision to schedule Stadol.

"I believe they were afraid of the domino effect," Douglas says. "Once we passed the rule to make it a controlled substance, then it would be easier for the next state to pass it.

"They came in with the sharpest lawyers they can find, the sharpest medical experts," says Douglas. "They tried to overpower the Board of Pharmacy and I was very impressed with the board in being able to stick by their guns."

But unlike New Mexico, many states have no mechanism at all to control drugs, and thus rely exclusively on the federal government to schedule them.

Still, the FDA failed to act, despite a growing number of reports of "drug dependence" submitted by physicians. Among other things, FDA documents obtained by Nightline document that "addiction appears to develop rapidly from Stadol and that abstinence from Stadol was very difficult."

In February 1995, Bristol-Myers Squibb itself wrote the FDA requesting that it schedule the nasal spray, because of a "modest number of reports of inappropriate use" of Stadol. Yet, at that same time, some of the company's marketing material aimed at patients contained no mention of Stadol's addictive properties.

"Every day of delay," asserts Dr. Wolfe, "that keeps the government from scheduling this drug means more sales. It's a game of how long can we wait until the curtain falls."

The FDA still refused to act. Instead, the agency sent a memo about Stadol to the states, suggesting "abuse problems would be best managed by the states."

More than two years after Bristol-Myers Squibb's request to the FDA, Stadol remains an uncontrolled substance. Nine months ago, the FDA did request that the federal Drug Enforcement Agency place controls on the drug.

Just yesterday the DEA finally began the process to have Stadol scheduled under the Controlled Substances Act. But it will be at least a month before it's official, and it could take even longer.

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