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Patients Injured and Killed As Doctors Prescribe Drugs for Unapproved Uses for DANGER by Alison Young and Chris Adams Knight Ridder Newspapers

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Patients Injured and Killed As Doctors Prescribe Drugs for Unapproved Uses for DANGER by Alison Young and Chris Adams Knight Ridder Newspapers Cyan Magenta Yellow Black BType A KNIGHT RIDDER SPECIAL REPORT CHIP SOMODEVILLA/DETROIT FREE PRESS Tammie Snyder holds Presley, one of her twin daughters, in New Baltimore, Mich. Snyder was prescribed an asthma drug to prevent premature labor. PRESCRIPTION Patients injured and killed as doctors prescribe drugs for unapproved uses FOR DANGER By Alison Young and Chris Adams Knight Ridder Newspapers NEW BALTIMORE, Mich. — For the last three standard studies backing an off-label use. But doctors routinely are phobia,” according to case notes from an office visit on Sept. 9, and a half months she was pregnant, Tammie Snyder choosing unapproved therapies that are questionable at best. 2002. had a small medical device strapped to her thigh. It The practice is perfectly legal, widely accepted and defended by The drug’s maker, Johnson & Johnson, has marketed Risperdal pumped a drug called terbutaline through her body to doctors and the American Medical Association — and it’s taking a toll. heavily to doctors who treat elderly patients. prevent her from going into labor too soon. Victims of off-label prescribing whom Knight Ridder interviewed In 1999 the FDA cited Johnson & Johnson for downplaying the On Sept. 17, 2002, Snyder gave birth to two have suffered heart attacks and strokes, had permanent nerve dam- drug’s risks to the elderly and making false and misleading claims healthy girls. Within days, however, her lungs filled age or lost their eyesight. Most said they never were told that the that it could be used not just to treat schizophrenia, but also “for psy- with fluid, her heart began to fail and she was told FDA hadn’t approved their treatments. chotic symptoms associated with a broad range of disorders.” she might need a heart transplant. She recovered, but Based on the FDA’s own data, Knight Ridder estimates that at While doctors are free to prescribe as they wish, the FDA pro- she’s been told she can never have a baby again. Her least 8,000 people became seriously ill last year after taking some of hibits drug-makers from marketing unapproved treatments. heart wouldn’t stand the strain. the nation’s most popular drugs off-label. The true number is likely Despite the FDA’s action, Risperdal has become a popular off- Terbutaline is an asthma drug, and the Food and Drug to be many times higher. label treatment for Alzheimer’s Administration hasn’t approved its use to prevent premature labor. “Sometimes it may help, disease and dementia. About The FDA has warned doctors that the treatment is “potentially dan- sometimes it may do more harm 670,000 such prescriptions were gerous” and may not be effective. Snyder said her doctor never told than good and sometimes it may Growth of off-label prescriptions written last year, up more than her about the warning or that the FDA had approved terbutaline only kill people,” said Arnold An analysis of prescriptions for the three 350 percent from 1998, the to treat asthma. Relman, a former editor of the best-selling drugs in 15 of the top drug classes Knight Ridder analysis found. A six-month Knight Ridder investigation has found that patients prestigious New England Journal shows significant growth in off-label prescribing. Sixty-five percent of Risperdal’s nationwide are being injured and killed as doctors routinely pre- of Medicine. Off-label drugs Drug sales prescriptions last year were for scribe drugs in ways the FDA never certified as safe and effective. Despite the rise in off-label unapproved treatments, generat- Prescriptions for a condition Total retail value of all Moreover, these unapproved prescriptions are soaring. Over the drug use, the FDA has done little not approved by the FDA ing $929 million in retail sales. 96% drug sales in analysis last year, 115 million such prescriptions were written, nearly double to discourage it, and is consider- increase Murphy had been a familiar the number of five years ago, an exclusive Knight Ridder analysis of ing whether to allow drug com- 1997-98 58.6 million $55.5 billion figure at his doctor’s office, prescriptions for the country’s top-selling drugs found. panies greater leeway in pushing 2002-03 115.1 million Off-label complaining of stomach pains, The practice, called off-label prescribing, often is driven by ques- unapproved therapies. $12.9 billion arthritis and the like, often con- tionable research, aggressive drug-company marketing and cavalier vinced that any pain was a sign I On-label drugs doctors, and condoned by tepid regulators. On-label that he was dying of cancer. Prescriptions for a condition $42.6 billion Doctors are giving their patients epilepsy drugs for depression George Murphy’s hands, approved by the FDA 84% But he was otherwise fit, his and hot flashes and to help them lose weight. They use antidepres- made strong by years of climb- increase Source: Knight Ridder analysis daughters said, enjoying family of prescribing data from Verispan’s sants to treat premature ejaculation and pain, and powerful antipsy- ing utility poles for Houston 1997-98 222.7 million Physician Drug and Diagnosis Audit dinners, a recent trip to an alli- and its Source Prescription Audit chotics for insomnia and attention deficit disorder. High blood-pres- Lighting & Power, shake with 2002-03 409.3 million for 12 months ending July 31 in gator festival and an active sure pills are prescribed for headaches and anxiety; antibiotics are tremors. His legs, now rigid, 1998 and 2003 social life at his independent used to treat viruses. shuffle as he pushes his walker © 2003 KRT Graphic: Judy Treible, Lee Hulteng living center. Some drugs, in fact, are sold mostly for unapproved purposes. through his studio apartment in The FDA hasn’t approved Eight out of 10 prescriptions for the epilepsy drug Topamax aren’t Deer Park, Texas. Risperdal for the treatment of hypochondria. But Murphy’s family for epilepsy. Thalidomide, the notorious morning-sickness drug that “I wish I didn’t have to use this thing,” he said as the walker members said they weren’t told this. Yaworski declined to be inter- caused horrible birth defects and ushered in today’s FDA drug-safe- snagged on his recliner while he was showing off his Army dog viewed. ty rules, today is on the market, and 99 percent of its prescriptions tags from World War II, a plaque for 40 years of service as a Within a month of starting the drug, Murphy had the first in a are off-label. Mason, his Shriner fez and the oil paintings his wife did a few years series of stroke-like events, called transient ischemic attacks, accord- Knight Ridder reviewed 15 top-selling classes of drugs and found before she died. ing to his family and hospital records. During the worst of them, on that some, such as cholesterol medicines, rarely are given as unap- Murphy, now 85, began having the tremors last year after he had Nov. 14, 2002, Murphy suddenly couldn’t walk, his speech became proved treatments. But three-quarters of anti-seizure medications are a series of stroke-like attacks while taking Risperdal, a powerful slurred and his face drooped. He became easily confused, and doc- prescribed off-label, as are nearly two-thirds of antipsychotics and antipsychotic drug that the FDA has approved only for treating tors at the hospital added dementia to his diagnoses. about one-quarter of antidepressants, the analysis found. schizophrenia. Attack followed attack, but Murphy kept taking his Risperdal. He For patients with rare, intractable or fatal illnesses, off-label pre- Murphy’s family practitioner in Pasadena, Texas, Dr. Dennis was still afraid of getting cancer, his family said. scribing is sometimes appropriate. In other cases, there may be gold- Yaworski, prescribed Risperdal for an off-label purpose: “cancer Then in April 2003, Johnson & Johnson sent a letter to U.S. doc- Cyan Magenta Yellow Black BType 5 25 50 75 100 three months at a time, but stud- ies have found that it’s frequent- What does ly prescribed improperly and that long-term use exposes ‘off-label’ mean? patients to unnecessary side When the FDA okays a new effects. drug, it also approves the One of the worst is tardive instructions, or label, for using dyskinesia, a condition that the drug based on data causes relentless body tremors submitted by the drug company. and facial tics. Baker, now 55, said she was never told about Off-label, or unapproved, uses this, so when she moved into her can include prescribing for: fourth month on the drug she Different diagnosis didn’t realize what was happen- Drug approved to treat one ing when she began to twitch condition, used for a different one every now and then. In her fifth month on Reglan, her symptoms worsened. Her Less severe disease primary care doctor quickly saw Drugs with risky side effects used to treat relatively minor conditions the connection. “It’s the Reglan,” she said he told her. “We have to get you Different length of treatment off it immediately.” Her special- Some drugs are safe when used ist, hearing the news, called for only a short time, but risky Baker at home, angry with her when used long-term for not alerting him to the oncoming symptoms. A patient of a different age “Don’t scream at me,” she Clinical trials often use middle- recalled saying during the June aged people, making many 2001 phone call. “You didn’t drugs off-label for children even warn me. You didn’t tell © 2003 KRT me.” Source: Knight Ridder Washington Bureau MICHAEL STRAVATO/KRT Graphic: Todd Lindeman, Judy Treible “Our father has been taken away from us.
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