Lynda Lee was recuperating in her Texas home following back surgery one day in November 2004. The 59-year-old nurse took the pain medicine her doctor had prescribed ? methadone ? then lay down on the couch in front of the television.
Her son found her there several hours later, dead. She had stopped breathing. The medical examiner said the cause of death was acute methadone intoxication.
?The coroner said there wasn?t much in her system. It could have just been two pills,? her daughter, Alisha Regan, told the Gazette.
Across the nation, the number of people methadone helped to kill tripled in just four years, from 790 in 1999 to 2,992 in 2003, according to an analysis of death certificates conducted by the Centers for Disease Control and Prevention?s National Center for Health Statistics at the Gazette?s request.
Regan wonders why so many doctors are prescribing methadone.
?There have been many deaths from methadone, and it?s still a top seller,? she said.
The reason, doctors and researchers say, is that methadone is cheap and effective in treating pain.
Insurance companies and state health plans are pressuring doctors to consider methadone as an alternative to more expensive painkillers, said several physicians contacted by the Gazette.
Many doctors don?t know how to prescribe methadone safely, said Howard Heit, a physician from Fairfax, Va., who specializes in treating pain and addiction.
?Insurance companies are forcing certain doctors to prescribe medications they don?t understand,? Heit said in a telephone interview. ?The companies are looking more to their bottom lines as opposed to being advocates for patients.?
Americans are consuming more methadone than ever before ? almost 10 times more last year than a decade before, according to data obtained from the federal Drug Enforcement Administration.
The companies that make methadone have seen their revenues rise, also. They have spent some of those millions on Washington, D.C., lobbyists.
One company, Tyco/Mallinckrodt, also provides grants to fund two Web sites edited by Stewart Leavitt, a methadone advocate and researcher who helped write the government?s response to methadone overdose deaths (see accompanying story).
A Tyco spokeswoman referred a reporter to Leavitt when asked about methadone?s safety.
Leavitt said the responsibility for methadone overdose deaths lies not with the companies that make it or the government that regulates it, but with doctors and patients.
?Ultimately, this is the individual responsibility of the citizen,? he said. ?At some point, people have to stand up and take responsibility for their actions.?
Yanked in the ?70s
Lynda Lee was a drug rehabilitation nurse for 25 years before her back pain forced her into temporary disability. Regan said her mother was more likely to try to battle through pain without taking her painkiller than to double up on a dose.
?She was one that would never even take an aspirin,? Regan said.
Lee had been taking morphine before her doctor switched her to methadone. Regan said she doesn?t know why her mother was switched because the morphine was working well, except that methadone was considerably cheaper.
After her mother died, Regan started looking for information on the drug.
?I never searched methadone online until Mom passed away,? she said. ?I couldn?t believe all the deaths I found.?
Methadone has been a controversial drug from its very beginning. At one point in the 1970s, the federal government was so worried about its safety that it yanked methadone from retail pharmacy shelves.
At the time, methadone wasn?t prescribed much for pain. German researchers had invented methadone during World War II, and the U.S. Food and Drug Administration approved it as a painkiller in 1947.
It gained a reputation as toxic and addictive soon after it hit the market and fell into disuse.
By the 1960s, researchers discovered methadone was good for something else: subduing heroin cravings. The FDA approved that new use in 1972 ? but it simultaneously decided that methadone should no longer be given for pain outside of a hospital, saying there was ?a lack of substantial evidence that methadone is safe and effective? as it was being used.
The American Pharmaceutical Association filed a federal lawsuit, and by July 1976 the FDA was forced to reverse its rule. Methadone was back on pharmacy shelves as a painkiller.
But methadone was not used widely for pain until the 1990s. Pain doctors and the drug industry argued that untold millions of Americans suffered from untreated pain. Doctors should be less afraid to prescribe powerful painkillers to subdue their agony, they said.
One of the most popular narcotic painkillers was OxyContin, which was extremely effective and powerful. But in the hollows of West Virginia and elsewhere, drug abusers discovered it could be crushed and snorted or dissolved in water and injected for a heroin-like high.
Soon, ?hillbilly heroin? earned its own bad reputation. Doctors and insurance companies looked around for alternatives. Methadone, relatively cheap and harder to abuse, became a fallback drug of choice.
Pressure to prescribe
Methadone is much cheaper than other narcotics. A one-month supply (90 pills of five milligrams each) costs about $8, compared with $80 for generic morphine or $100 for OxyContin, according to First DataBank, a national reference of prescription drug prices.
Insurance companies, workers? compensation programs and state health programs like Medicaid all are pushing methadone over more expensive alternatives, said Lynn Webster, a pain researcher and physician from Utah.
Webster told the Gazette he feels pressured to prescribe methadone by insurers.
?I?ve had insurance companies deny payments for OxyContin because they feel it is not indicated. Or they say they aren?t going to pay for enough of the drug to be effective, so we can?t control pain at the amount they authorize,? Webster said. ?We can either prescribe methadone or nothing at all.?
Several states, including West Virginia, have added methadone to their preferred drug lists. That makes it easier for doctors to prescribe than other drugs that require prior approval from the state.
Federal programs are asking doctors to prescribe methadone, too.
?If there are two medications out there that are equally effective, the Veterans Administration will choose the less expensive alternative every time,? said James Toombs, a pain researcher and physician at a VA hospital in Columbia, Mo., in a telephone interview.
Sales soar for manufacturers
The companies that make methadone have seen huge increases in sales as the drug?s popularity has risen.
One of the world?s largest makers of opioid pain drugs is Tyco, the same company whose top executives were jailed for looting millions from the company. Company officials agreed to pay a $50 million fine to settle allegations of inflated company earnings.
Tyco also employed Republican lobbyist Jack Abramoff to help it avoid taxes and get government contracts, according to published reports. In January, Abramoff pleaded guilty to federal charges of fraud, tax evasion and conspiracy to bribe public officials.
Tyco got into the methadone-making business in 2000, when it bought a company called Mallinckrodt Inc.
The revenues generated by Tyco/Mallinckrodt increased 22 percent between 2001 and 2005, according to U.S. Securities and Exchange Commission filings, from $7 billion to $9.5 billion.
The company makes many drugs, mostly generic. In several SEC filings, company officials credit some of their increased profits to the sale of narcotics like methadone.
In just one year, the amount of methadone and other narcotics the company sold jumped 30 percent, according to a 2000 company report.
Another large manufacturer of methadone, Roxane Laboratories of Columbus, Ohio, has helped boost sales for its owner, a German conglomerate called Boehringer Ingelheim Inc.
The German company?s net revenues grew by 42 percent between 2001 and 2005, from about $8.6 billion to $12.2 billion, according to company reports.
Those companies are investing some of that money in Washington, D.C., lobbyists. Between 1998 and 2004, Tyco paid lobbyists $4.1 million and Boehringer Ingelheim paid lobbyists $860,000, according to the non-partisan Center for Public Integrity.
Tyco/Mallinckrodt sponsors continuing education courses and information sessions at industry conferences to provide doctors and pharmacists with up-to-date information about methadone, company spokeswoman JoAnna Schooler told the Gazette.
Mallinckrodt has supported the Addiction Treatment Forum, which Leavitt edits, since 1992, and Leavitt?s other Web site, Pain Treatment Topix, since before it went online in January.
Leavitt said he is afraid bad publicity about methadone will scare doctors and patients who need to use it. He said educational efforts such as his Web site are the best way to reduce accidental overdose deaths.
Some family members of methadone overdose victims want to go further. Some say they want the drug locked up in secure boxes. They want the warnings on the drug?s package insert, which the FDA approved, to be stronger.
Regan said the drug shouldn?t be given outside of hospitals, if at all.
?If they could take it off the market, I?d be all for it. I think they could come up with something else for the drug rehab centers,? she said. ?Because I know it?s taken a lot of loved ones from families that didn?t deserve it.?
Regan?s mother had four children, four grandchildren and a great-grandchild.
?She was a wonderful person,? Regan said. ?She would give anyone the shirt off her back or everything in the refrigerator ... I don?t know, everybody seemed to love her.
?I just wish she was still here.?
To contact staff writers Scott Finn and Tara Tuckwiller, use e-mail or call 357-4323 or 348-5189.