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By Evelyn Pringle (about the author) Page 2 of 12 page(s)
In the summer of 2002, Mr Jones discovered an off-the-books account where drug companies were depositing "educational grants" from which state officials and policy makers involved in developing Pennsylvania's drug list were receiving payments.
"We had state officials accepting $2,000 honorariums," he noted, "and physicians who were taking trips, perks and gratuities."
One of the officials Mr Jones named in his investigation was the state pharmacist, Steven Fiorello. In April 2005, the State Ethics Commission fined Fiorello over $27,000 after finding that he repeatedly took money from drug makers, Pfizer and Janssen, while serving on the panel that decided which drugs could be given at 9 state mental hospitals. The commission's report cited repeated failures to disclose his income from the drug companies.
On June 10, 2005, Senators Chuck Grassley and Max Baucus announced the beginning of an investigation by the Senate Finance Committee, which has oversight responsibility for government health care programs, into the practice where drug companies give money to state governments.
"The drug companies call the awards educational grants," their press release said, "but the senators are concerned that the dollars are more focused on product promotion than education."
The Senators said their inquiry was based on reports that companies have awarded grants as inducements to prescribe medications the companies produce.
In some cases, they said, "such grants to state agencies may have prompted those agencies to develop programs leading to over-medication of patients at the expense of patient health or to unnecessary expense for taxpayers."
"We need to know how this behind-the-scenes funneling of money is influencing decision makers," Senator Grassley said. "The decisions result in the government spending billions of dollars on drugs."
In recent years, investigations into the prescribing patterns for people on Medicaid and Medicare has led to the discovery of a drastic increase in off-label prescribing to children and the elderly of drugs never approved for use with children and the elderly.
One class of drugs found to be prescribed off-label most often without scientific support are psychiatric medications. In 96% of the psychiatric drugs prescribed off-label, the Archive study found support was lacking.
According to the report, Death by Medicine (2003), by Gary Null, PhD; Carolyn Dean MD, ND; Martin Feldman, MD; Debora Rasio, MD; and Dorothy Smith, PhD, a study on prescription drug use by the elderly conducted by Medco Health Solutions found that 6.3 million senior citizens received more than 160 million prescriptions and a total of 7.9 million medical alerts were triggered by off-label prescribing, with 2.2 million alerts indicating excessive dosages unsuitable for seniors, and about 2.4 million indicating clinically inappropriate drugs for the elderly.
Drug companies have promoted the off-label use of psychiatric drugs with children even after their own studies have shown the drugs to be dangerous. In 2004, New York attorney general, Eliot Spitzer, filed a lawsuit against GlaxoSmithKline for withholding studies that raised doubts about the effectiveness and safety of Paxil in treating children and revealed that more than 2 million prescriptions for Paxil were written off-label to treat children in 2002.
In late 2004 the FDA ordered black box warnings on all SSRI antidepressants after it was discovered that drug makers had suppressed studies that showed the drugs were linked to an increased risk of suicide in children.
Documents that have surfaced during litigation reveal that drug makers knew about this risk before the SSRI antidepressants arrived on the market but continued to find ways to get doctors to prescribe the drugs to kids. A report by Express Scripts, Inc, a pharmacy benefit manager, titled "Trends in the Use of Antidepressants in a National Sample of Commercially Insured Pediatric Patients," shows that between1998 and 2002, the overall use of antidepressants among children increased from 160 children per 10,000 in 1998, to 240 per 10,000 in 2003.
Tom Woodward's daughter Julie hung herself after being prescribed the antidepressant, Zoloft, off-label. He is angry at the Bush administration and the FDA for failing to protect the public against drug companies who hide studies that show drugs are dangerous when given to children.
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