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Feds refuse to limit production of deadly Oxycodone

An epidemic of Oxycodone abuse has struck America in the last decade. The number of emergency room visits stemming from nonmedical abuse of the narcotic prescription painkiller drug rose by 256 percent between 2004 and 2009, according to the U.S. government's Drug Abuse Warning Network.

In Florida, the Medical Examiners Commission found more than 1,500 people died of Oxycodone overdose in 2010, a four-fold increase over the 350 who died in 2005. The supply of Oxycodone, says Jim Hall, director of the Center for the Study and Prevention of Substance Abuse at Nova Southeastern University, went "far beyond the legitimate medical need of the state."

The epidemic is not likely to abate soon. The explosion of pain management clinics in Florida, dubbed "pill mills," prompted the state Legislature last year to close a loophole that had allowed physicians to fill Oxy prescriptions on the spot. Authorities say a half-billion doses of Oxycodone and its generic equivalents were distributed in the state during 2009 alone. An unknown number wound up in the hands of "patients" who had come from out of state to have prescriptions filled by multiple pill mills, before driving home to resell the pills on the black market.

Florida is not the only state where Oxycodone is being over-prescribed. The number of pills prescribed in Ohio has risen by 900 percent since 1997, a powerful indicator that the market for pills has become oversaturated.

"There's just no way that there's been a 900 percent increase in pain," says Stacey Frohnapfel-Hasson, chief of communications for Ohio's Department of Alcohol and Drug Addiction Services.

1,200 percent increase

One of the most disturbing things about the prescription pain pill abuse epidemic is that it could have been avoided, or at least mitigated, if the Drug Enforcement Administration had fulfilled the responsibilities vested in it under federal law.

That's the view of Gene Haislip, who, until his retirement in 1997, spent 17 years as the head of one of the least publicized law enforcement entities in Washington: the DEA's Office of Diversion Control.

"For those of us who devoted our careers to the DEA and drug enforcement, we really love the agency, but you can't love them when they screw up," Haislip said. "You've got to have some kind of principles."

It's well known that narcotic prescription drugs sold in the United States must first be approved by U.S. Food and Drug Administration before they can be legally mass produced and marketed. Less known is that the DEA — and specifically, the Office of Diversion Control — has the power and responsibility to decide how much of a particular drug can be legally manufactured and sent to market each year.

The pharmaceutical companies that make Oxycodone and its two dozen generic equivalents — such as Endocodone, Oxyfast and Percocet — are required by law to present an annual application to the Office of Diversion Control seeking approval for a quota of the drug's annual production. Should a company desire to manufacture more than the previous year, it must request an increase — and the DEA must approve.

The DEA declined to respond to my request for the names of the companies that have been granted the biggest manufacturing quota increases in recent years. But information gleaned from the agency's website, combined with statistics provided by Haislip, show the aggregate increase granted to all companies making the potent painkiller has been staggering.

In 1997, a year after prescription drug maker Purdue Pharma first brought oxyContin (the first branded version of Oxycodone) to market, the total production quota approved by the Office of Diversion Control was 8.3 tons. By 2011, it had risen to 105 tons, an officially sanctioned 1,200 percent increase over the same period that saw Oxycodone emerge as what Haislip calls "the Cadillac of America's prescription drug abuse crisis."

That the DEA allowed for the increases in the face of widespread illegal and nonmedical use shows a "serious lack of accountability and oversight," says Haislip.

"The DEA is the lone federal agency with the power to decide how much of the drug gets made and put out there; it alone has had all the responsibility to do something about this problem," he said. "The way I did it for 17 years, which was basically the way it had always been done even before the DEA was the DEA, is that when a significant diversion problem occurred, the quota increase requests would come under greater scrutiny."

"With Oxy," said Haislip, "there has been a significant diversion problem since the late 1990s, so the requests should have come under greater scrutiny." That apparently didn't happen, he says.

Past successes ignored

What's particularly disturbing, Haislip asserts, is that the DEA has failed to draw wisdom from two clear-cut examples over the past 40 years in which manufacturing quotas were cut as a means of reducing widespread abuse.

The first occurred in the early 1970s when pill-based amphetamines became a staple of America's black market drug trade. In 1973, the DEA enforced a 90 percent reduction in domestic amphetamine production over two years, resulting in what John E. Ingersoll, director of the DEA's predecessor agency, the Bureau of Narcotics and Dangerous Drugs, told Congress was "a sharp reduction" in the illicit market.

A second example occurred during the early 1980s, when Haislip had first taken over the DEA's newly minted Office of Diversion Control. Between 1980 and 1982, the office enforced a 74-percent cut in the manufacturing quota for Methaqualone, the core ingredient of the sedative-hypnotic drugs known as Quaaludes. The quota cuts, coupled with a coordinated effort to block illegal international flows of the drug into the United States, had effectively erased the problem of Methaqualone abuse.

The DEA's unwillingness to embrace such a strategy toward Oxycodone perplexes those now battling the abuse crisis at the state and local level.

"If containing the number of prescription opiates is as simple as just the DEA limiting quotas, it's really kind of tragic that loss of life and the carnage associated with this could have been prevented," Orman Hall, director of Ohio's Department of Alcohol and Drug Addiction Services, told me.

The Obama administration, meanwhile, is neutral toward the quota increases. My request to interview officials within the White House Office of National Drug Control Policy (ONDCP) was ignored. Perhaps most disconcerting was ONDCP's response to my question about DEA approval of manufacturing quotas for narcotic opioids:

"DEA and FDA work together to establish the quotas for controlled substances," the spokesman wrote. "Our data show that dispensed prescriptions for opioids between 2008 and 2009 did not increase. This stabilization in dispensed prescriptions was then followed by a period of flattening in the total production quota for oxycodone, hydrocodone, methadone, morphine, and oxymorphone in both 2010 and 2011. This suggests a leveling off in production."

The realm of secrecy

The ONDCP response did not address the question of whether the prescription painkiller market had been oversaturated by production increase over the last decade. And given the massive production increases approved in the secretive decision-making process, the claim that the FDA and the DEA "work together" is less than reassuring.

"We protect the data regarding the quantity that we give to individual companies so that they don't know what each other is doing and get an unfair marketing advantage," said Gary Boggs, a DEA supervisory special agent, in an interview.

When asked why such significant increases in Oxycodone manufacturing have been allowed in the last decade, Boggs asserted that the DEA is required by statute to set the quotas at a level that ensures "an uninterrupted supply for the legitimate medical and scientific research needs of the United States" and that those needs are "always changing as the population grows and as medical science finds different needs for products."

"I can assure you that there's no collusion between the drug companies and the DEA," he said. "We battle quite regularly with the pharmaceutical industry on how much quota they ask for and how much they receive. On many instances, we do not give companies the amounts that they ask for."

But wouldn't the widespread abuse and diversion of a drug in recent years warrant cutting the quota? I asked.

"What you have to understand," Boggs replied, "is that you do have legitimate patients and they're fishing from the same pond that the illegitimate patients are fishing from, so you have to be cautious not to restrict the quota to the point that when the legitimate parties go to the pool, all the fish haven't been taken out by the illegitimate parties."

The U.S. government has adopted a position on prescription painkillers that differs from its policy toward other controlled substances such as cocaine, heroin and marijuana: Unlike those drugs, the DEA says limiting the supply of the prescription painkillers will not reduce abuse.

So while the Justice Department's 2010 National Drug Threat Assessment blames the staggering growth of prescription painkiller abuse on the "rapidly increasing distribution" of prescription opioids, it includes an inconspicuous footnote defending the DEA's role in approving the rapidly increasing production of the drugs at the same time.

Contributing factors to quota increases include: more aggressive pain treatment, new and different indications for legitimate medical use, the increase in the average age of the citizenry, new delivery methods and formulations for opioid pain relievers, new product development, and exportation. Thus, decreased production is not viewed as a realistic means to reduce diversion.

The role of the FDA in the approval of manufacturing more prescription painkillers is also shrouded in secrecy. The FDA, said spokesman Shelly Burgess, supplies the DEA with annual reports "summarizing drug usage and shortage data, prescribing trends and estimates of futures needs." But the FDA reports cannot be released publicly, she said, because they contain "commercial confidential information."

'Devious means'

To understand why the FDA and DEA so protect the interests of certain companies, it's worth remembering what Marcia Angell, former editor of the New England Journal of Medicine, pointed out in her 2004 book, The Truth About the Drug Companies. The Pharmaceutical Researchers and Manufacturers of America (PhRMA) employs more lobbyists in Washington than there are members of Congress.

Since 2007, the group has spent more than $20 million annually on lobbying in Washington to see that its interests are protected.

That influence is felt in the offices of the DEA, says Haislip.

"For a DEA official to put his or her neck on the line to block a company's requested quota increase takes an awful lot of guts and a lot of hard work, particularly if that company is supporting members of Congress who have the power to block the agency's funding," he said.

All the big-name pharmaceutical companies that make Oxycodone products — including, but not limited to, Pfizer, Purdue Pharma and Endo Pharmaceuticals — are members of PhRMA. They also spend additional millions lobbying annually for their own specific interests. And they are the biggest donors to a national nonprofit organization known as the American Pain Foundation. According to the organization's most recent annual report, the American Pain Foundation had a budget of roughly $5 million for 2010. Endo Pharmaceuticals, the maker of a variety of Oxycodone-based painkillers including Percocet, gave more than $1 million. Pfizer and Purdue donated between $100,000 and $500,000 last year.

The organization and others like it push the message, both publicly and in Congress, that "there is this supposed untreated pain epidemic in America," says Philip Prior, a consultant to the Ohio Department of Alcohol and Drug Addiction Services. "They've launched this massive lobbying effort to promote prescription narcotics to treat everything. What the pharmaceutical companies have managed to do with narcotics over the last 20 years is essentially addict a large portion of our population through devious means."

Captives to Big Pharma

The drug companies also benefit from a proverbial "revolving door" between government and special interests.

In the early 2000s, the West Virginia attorney general brought a civil case against Purdue Pharma, accusing the company of engaging in coercive and deceptive marketing techniques. The lawsuit was resolved in 2004 when Purdue Pharma agreed to pay $10 million over four years into drug abuse and education programs in the state. The settlement was negotiated on Purdue Pharma's behalf by Eric Holder Jr., then a private attorney, who five years later became the chief of the Justice Department, which oversees DEA.

There is also a revolving door between the DEA's Office of Diversion Control and the pharmaceutical industry. For example, Mark W. Caverly served as chief of the Liaison and Policy Section within the Office of Diversion Control at DEA until early this year. It was his job to work with DEA-regulated industries and associations, providing interpretations of federal law and regulations to congressional staff, DEA registrants and the general public. In May, Cegedim Relationship Management, a consulting firm based in New Jersey and owned by a French multinational, announced it had hired Caverly. The firm specializes in facilitating "compliance" with DEA regulations.

Cegedim's chief compliance officer, Ron W. Buzzeo, is himself a DEA retiree who served as a deputy director of the Office of Diversion Control from 1982 through 1990. In an interview, Buzzeo dismissed the suggestion that there might be a conflict of interest. "To help somebody meet the regulatory requirements? Why would that be a conflict of interest? I don't understand the question," he said.

Frances Hughes, chief deputy to West Virginia's attorney general, said the fact that people working in the Office of Diversion control know that they might get lucrative work with drug companies upon retirement constitutes a conflict of interest that prevents DEA officials from doing their duty.

"Are you really going to strike out and be on the front lines against an industry that you might depend on for a job after you retire from the DEA?" she asked. "No. Are you going to offer an opinion or do something that's going to cut off your flow of money? No."

"It's insidious and the result is that you have agencies that become captive to the regulated industry," Hughes added. "In this case, it would be terrible if we had the DEA being a captive of the pharmaceutical industry."

Guy Taylor is an investigative journalist and filmmaker who lives on Cape Cod, in Massachusetts. He received a 2011 grant from the Fund for Investigative Journalism to pursue this story.

Feds refuse to limit production of deadly Oxycodone 11/01/11 [Last modified: Tuesday, November 1, 2011 4:55pm]

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