But conference participants concluded that liquid methadone from drug-treatment clinics was not the culprit � pain pills were.
Therefore, changing the label or sending out a warning to the public would do little good, they said.
�At the time, it didn�t seem like physicians and patients were the problem,� Winchell said. �It seemed like it was people who got ahold of the drug who weren�t patients.�
The conference report did say that doctors and legitimate patients were part of the problem. One of three likely scenarios for a methadone overdose death was �in the context of legitimate patient care, methadone accumulates to harmful serum levels during the first few days of treatment for addiction or pain.�
�Radical� dose change
In June, the Sunday Gazette-Mail investigation revealed for the first time that the increasingly popular painkiller methadone is a factor in the deaths of more people nationwide than any other prescription narcotic � 2,992 people in 2003.
The investigation also found that some people took their methadone exactly as prescribed and died anyway. It found that the �usual adult dosage� on the package insert patients got with their bottles of methadone pills could kill. It found that despite knowing about methadone�s dangers, federal officials had not strengthened warnings on the pain pills.
The findings alarmed Dr. Robert Newman, director of the International Center for Advancement of Addiction Treatment, Baron Edmond de Rothschild Chemical Dependency Institute of Beth Israel Medical Center in New York.
He had assumed pain patients got the same low, safer starting methadone doses that addiction patients get.
�The first public reference [to the dosing discrepancy] I have seen came from your article in the Gazette,� said Newman, who has spent his career advocating access to methadone treatment for addiction. �If I had known, I would have been on the warpath ....
�There is nobody in this field, going back 25 years, that would say there was any question: If you exceed 30 to 40 milligrams on day one for a methadone maintenance patient, you are risking an overdose situation.�
The Compliance Office, the branch of the FDA that knew about the difference, dealt with methadone clinics in the 1980s. It is not the same branch that deals with painkiller safety, said Winchell of the FDA.
Newman worries doctors and pharmacists won�t notice that the FDA has cut its maximum dosing recommendation for pain methadone in half.
The new �usual dose� is mentioned once, on page 15 of a 17-page �prescribing information� document.
�I think the real story is the usual dosage has changed radically,� Newman said. �It�s not even mentioned in the [public health] advisory. It�s not even mentioned in the patient information sheet.
�How is a physician, reading the press or reading the advisory, going to be tipped off that there has been a radical change? How is the pharmacist going to know?�
The FDA believes any doctor who reads the public health advisory will check the dosing recommendations, Rappaport said.
Newman said he would like to see the FDA send every Drug Enforcement Agency-registered physician � all of them can prescribe methadone � �a separate, strongly worded advisory saying, �This is the change in dosage.��
Otherwise, he said, doctors might not realize they could be part of the overdose problem.
�Reading the advisory, the only conclusion a reasonable person can make is, �Gee, I guess patients have just been taking this stuff the wrong way.��
To contact staff writers Scott Finn or Tara Tuckwiller, use e-mail or call 357-4323 or 348-5189.