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ST. PETERSBURG, FLA (June 12, 2003) - At 4 years old, Logan Blevins was so disruptive that his mother took him out of preschool. He hit other children, ran into traffic and screamed at the top of his lungs. Logan has attention deficit hyperactivity disorder. Doctors prescribed Adderall, a stimulant. But the boy couldn't eat and needed Valium to get to sleep. Then doctors placed him on Strattera, a new drug approved by the Food and Drug Administration that went on the market in January. It is the first new drug approved for ADHD in three decades and is not a stimulant. |
 Tammy Blevins of St. Pete Beach folds laundry Wednesday with her triplets, from left, Louisa, Lucas and Logan. Blevins says a new drug that doctors prescribed for her sons has helped them battle ADHD and improved the grades of one son. "Within three days, my whole life turned around." |
Logan, now 7 years old, went from failing to passing first grade in three months.
"Within three days, my whole life turned around," said Logan's mother, Tammy Blevins, in an interview at her home in St. Pete Beach. "It was a miracle. Within three days, we were given this wonderful, sweet child."
But now Blevins can't get the state to pay for the drug, and she worries how she's going to pay for it after an initial supply of free samples runs out. The 35-year-old loan officer, who has no health insurance, pays $15 a month for her five children to be covered by the Florida Healthy Kids Corp. The state-subsidized program provides coverage for children who do not qualify for Medicaid.
The insurance company hired by Healthy Kids to provide coverage requires patients to try two stimulants, such as Ritalin or Metadate CD, before they try Strattera. The company, Amerigroup, covers 65,453 Healthy Kids clients in Pinellas, Hillsborough, Pasco, Orange, Osceola, Palm Beach, Polk and Seminole counties.
Healthy Kids is investigating the situation with the Blevins family. The nonprofit organization requires the 12 insurers it contracts with to follow Medicaid rules for coverage. Paula Kiger, Healthy Kids' director of operations, said it is not clear whether Amerigroup's rules are at odds with Medicaid's.
Doctors also prescribed Strattera for Logan's brother, Lucas. Amerigroup, which took over coverage of the Blevinses earlier this year, would not pay for the drug for Lucas. The brothers and a sister are triplets.
Blevins wonders why an insurer that serves mostly children would steer them to stimulants rather than the only drug on the market that is not a stimulant.
Amerigroup's vice president of pharmacy programs, Mike Medel, said a committee of outside doctors and pharmacists reviewed Strattera in February. The committee decided the drug would not go on the company's list of preferred drugs because the study group used to test the drug was not large enough.
"When it's rolled out to the general masses, you start to see how the drug is going to react, and the committee was concerned about putting this medication on, given the study population," Medel said.
Eli Lilly and Co., which developed Strattera, received FDA approval after submitting six clinical trials on 759 children and 536 adults for six to nine weeks, according to Strattera's label. It has not been studied in children younger than 6.
David Shaffer, a spokesman for Eli Lilly, said the drug has been tested on about 6,000 people, though he acknowledged that half of them have been tested since the FDA approved the drug, and 1,700 were tested for conditions other than ADHD. Since it went on the market, doctors have written about 700,000 prescriptions for Strattera.
"I think it's important to have open access for everyone to the medicines the FDA has determined are safe and effective and leave the prescription decisions in the hands of physicians," Shaffer said.
Strattera works by blocking the uptake of norepinephrine, a chemical in the brain that sends messages between nerve cells. It is estimated that 2 to 7 percent of school-age children suffer from ADHD, which is marked by inattention, hyperactivity and impulsive behavior. It is the most commonly diagnosed behavioral disorder among children.
Commonly used drugs for ADHD and attention deficit disorder are Ritalin, Concerta, Adderall and Metadate, which range in price from $50 to $95 for a 30-day supply. Strattera costs about $100 a month per child.
Strattera's side effects are similar to those of the stimulants. They include upset stomach, nausea or vomiting, diminished appetite, dizziness, tiredness and mood swings.
Dr. Jeffrey Alvaro, a child and adolescent psychiatrist at All Children's Hospital in St. Petersburg and a clinical professor of psychiatry at the University of South Florida, said the stimulant drugs are still the first-line defense against ADHD. But he said Strattera can be helpful for children who don't do well with the stimulants. He has prescribed it to about 80 children.
He said he has not had problems getting approvals from most insurance companies.
"Basically, we have to explain why we want to use a medicine other than what's recommended," Alvaro said. "Sometimes they're a little resistant, but for the most part we're able to get it approved. This often happens with new medications."
Larry Sasich, a pharmacist and research analyst at the Public Citizen Health Research Group in Washington, said Strattera has not been shown to be more effective than other drugs on the market for ADHD and much is still not known about it. He pointed out that the FDA has withdrawn 11 new drugs from the market since the mid 1990s.
Meanwhile, Blevins is running out of Strattera and may have to pay out of her pocket for the drug. She refuses to put Logan or Lucas on other drugs on the insurance company's preferred list because they are stimulants.
"I know in my heart," Blevins said of the insurers, "what they're doing is wrong."
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Source: St. Petersburg Times
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