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the FDA failed to heed a key piece of research indicating tramadol had the potential to be abused when it first appeared on the U.S. market in 1995. The drug was not placed under the Controlled Substance Act.
Despite recent research affirming its abuse potential, restrictions on prescribing it are no more stringent than for Lipitor or Viagra.
The Controlled Substance Act places drugs into five progressively restrictive categories based on their abuse potential. At the top of the list are drugs such as heroin. At the other end are cough medicines with limited amounts of codeine.
In deciding tramadol need not be on the list, the FDA based its decision largely on research in which the drug was injected as well as reports from Europe, where it had been on the market for years, that showed very little abuse.
However, the agency also had unpublished research showing that when given to opioid abusers orally in high doses, rather than being injected, it produced opiate-like effects that were similar to those from oxycodone, the narcotic in OxyContin, one of the most abused drugs in America.
Tramadol was first introduced in Germany in 1977.
Data from Germany had suggested it was only about one-tenth as potent as morphine when injected. Other data showed that after years of use in Germany and other countries there was very little abuse of the drug.
However, in the early 1990s, researchers at Johns Hopkins University did a study in which high doses of the drug were given orally to opioid abusers. Taken that way, tramadol acted much differently than when injected.
At very high doses it produced opiate-like effects that were similar to high-dose oxycodone.
Taken by mouth, the drug is transformed in the liver to a metabolite known as M1, which is able to attach to and activate opioid receptors in the brain. It is M1 that is believed to produce the desirable, opiate-like effect.
In 1994, Ortho-McNeil, part of the R.W. Johnson Pharmaceutical Research Institute of Johnson & Johnson, sought approval from the FDA to sell its brand-name version of the drug, Ultram, in the United States.
The Johns Hopkins study never was published, but the company said it was provided to the FDA.
That was when the FDA allowed Ortho-McNeil to fund its own committee, separate from the FDA, that would monitor the country for problems with the drug.
While it was called an 'independent steering committee,' Ortho-McNeil paid for the group's work and also paid consulting fees to its members.
Sidney Schnoll, a former member of the committee, said he could not remember how much the committee members were paid. In total, the program cost Ortho-McNeil about $15 million a year, said Schnoll, now an executive with Pinney Associates, a Bethesda, Md., company that works with drug and opioid companies.
'There was absolutely nothing independent about this group,' said Andrew Kolodny, a New York addiction specialist and advocate of tighter controls on opioids.
From early on, Ortho-McNeil's marketing plan for tramadol meant keeping it off the list of controlled substances where it would have difficulty competing against other narcotic painkillers such as Tylenol 3 and Tylenol 4, Schnoll said in a 2009 interview. Both Tylenol products contain codeine and are schedule 3 drugs.
The Schnoll interview was done by two professors, one from the University of Florida and one from Rensselaer Polytechnic Institute in New York, as part of a project at University of Michigan Substance Abuse Center.
'There were equally good products that were cheaper on the market,' Schnoll said, according to a transcript of the interview. 'So they really wouldn't have much of the market. They wanted to see if it would be possible to get the drug onto the market as a non-controlled substance.'
After a decade, the eight-member Ortho-McNeil committee dissolved itself in December 2005, without ever having recommended that tramadol be put under the Controlled Substances Act.
An analysis by the Journal Sentinel and MedPage Today found that tramadol use is up dramatically since 2008, the earliest year for which data is available. It rose from 25 million prescriptions that year to nearly 40 million in 2012, according to data from IMS Health, a market research firm.
In 2011, the drug was linked to 20,000 emergency department visits around the country. In Florida alone, there were 379 overdose deaths involving tramadol that year, up from 106 in 2003, according to the DEA.
In Milwaukee County, 20 people died of a drug overdose involving tramadol from 2010 through October 2013, according records from the Medical Examiner's Office. In most of those cases, tramadol was one of several opioids that had been taken.
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