Senator calls for investigation of Purdue Pharma following Times story on OxyContin
May 27, 2016
A U.S. senator on Friday called for federal investigations of OxyContin’s manufacturer in response to a Los Angeles Times report that found the bestselling painkiller wears off early in many patients, exposing them to increased risk of addiction.
Sen. Edward J. Markey, a Massachusetts Democrat whose state has been hit hard by prescription drug abuse, urged the Justice Department, the Food and Drug Administration and the Federal Trade Commission to launch probes of drugmaker Purdue Pharma.
OxyContin’s main selling point is that it lasts 12 hours. The Times investigation published this month found that when the effects don’t last, patients can suffer symptoms of narcotic withdrawal, including intense craving for the drug, and experience a cycle of agony and relief that experts say promotes addiction.
The newspaper found that Purdue had evidence of the problem for more than two decades, but continued to insist the drug lasted 12 hours, in part, to protect its revenue. OxyContin’s market dominance and premium price hinge on its 12-hour duration. Purdue instructed doctors who complained about the drug’s duration to prescribe stronger, but not more frequent, doses. Research shows that patients taking high doses of opioids are at greater risk of an overdose and death.
“These are serious allegations,” Markey wrote of The Times’ findings in a letter to Atty. Gen. Loretta Lynch. “They raise questions about ongoing deception by Purdue, harm to the public, continued costs to the United States, and the availability of further judicial recourse against Purdue…”
In a separate letter to the heads of the FDA and FTC, Markey called OxyContin “a leading culprit in the current opioid and heroin overdose epidemic.” More than 194,000 people have died from overdoses involving opioid painkillers since 1999 and abuse of those drugs is blamed for the resurgence in heroin addiction in the U.S. Markey said the agencies should “proactively warn prescribers, patients, and the general public” about problems the newspaper identified with OxyContin.
Purdue, a family-owned Connecticut company that has collected more than $31 billion from OxyContin sales, rejected The Times’ findings. In a statement, the company said Purdue shared Markey’s concerns about the opioid epidemic, but noted that the FDA approved OxyContin as a 12-hour drug.
“We promote our medicines only within the parameters approved by FDA and, given FDA has not approved OxyContin for eight-hour use, we do not recommend that dosing to prescribers,” the statement said.
A Justice Department spokesman said the department was reviewing the letter and an FTC spokesman confirmed the agency had received the letter, but declined comment.
An FDA spokeswoman said the agency was reviewing the letter and would respond directly to Markey. Previously, the agency spokeswoman told The Times the FDA “will revise labeling as necessary to improve proper prescribing and treatment,” but also placed responsibility with doctors.
“It should be well understood by physicians that there will be some individual variability in the length of time that patients respond to this drug,” the spokeswoman said.
Dr. Lewis Nelson, a New York University professor of emergency medicine who has advised the FDA on risks of prescription opioids, said that in his experience teaching physicians around the nation, many doctors have forgotten their medical school training about how opioids work in individuals.
“I don’t think the average doctor would recall the difference between changing a dose to q8,” medical shorthand for every 8 hours, “or increasing the dose,” Nelson said.
He said the Times findings were credible and the FDA “should change the label.”
“It would seem like this is a very fixable problem,” Nelson said.
OxyContin’s history is inextricably linked with the prescription drug epidemic. Purdue launched the drug in 1996 with an aggressive marketing campaign to primary care doctors that presented the painkiller as appropriate treatment for back aches and knee pain. Purdue and three company executives pleaded guilty in 2007 to federal charges of drug misbranding for what the company acknowledged was an attempt to downplay OxyContin’s risk of addiction. They were ordered to pay $635 million.
Markey has been an outspoken critic of the role of pharmaceutical companies and the FDA in the opioid crisis. In January, he temporarily blocked the nomination of Dr. Robert Califf as FDA commissioner to protest the agency’s approval process for opioids, including its August decision to approve OxyContin for use in children as young as 11. Califf was later confirmed.
“OxyContin is the original sin of the current opioid epidemic," Markey said in a statement to The Times. "For years, Purdue Pharma lied to federal regulators and the public about the addictiveness of OxyContin and countless patients got hooked on this deadly painkiller. We need to know if Purdue once again lied about the longevity of OxyContin’s pain-relieving properties and hold Purdue accountable."
Markey’s focus on opioids reflects Massachusetts’ severe problem with painkillers and heroin, which has been embraced by many prescription drug addicts as a cheaper alternative to pills. The death rate from opioid overdoses is more than twice the national average – and climbing. More than 1,300 people died from opioid-related causes last year, according to the Massachusetts Department of Public Health.
“Four people die every day and we haven’t been able to bend the trend,” said Marylou Sudders, the commonwealth’s secretary of health and human services. “That’s not a problem. That is a crisis.”
Sudders attributed the problem, in part, to doctors over-prescribing opioids. A state law passed in March requires doctors to receive additional training and limits first-time opioid prescriptions to seven days.
The Times report concerned an issue that went largely unnoticed in the scrutiny of OxyContin: the drug’s duration. Purdue’s clinical trials demonstrated the problem. In the first test on patients, for example, OxyContin wore off early in about half of participants.
After the drug hit the market, the company was confronted with additional evidence, including complaints from doctors and research by outside scientists.
In his letter to Lynch, Markey wrote that “if warranted” the Justice Department should try to recoup “taxpayer dollars that federal healthcare programs may have needlessly and unnecessarily spent on OxyContin prescriptions.”
UPDATES:
12:52 p.m.: This post has been updated to include statements from the FTC and statistics about opioid deaths in the U.S.
10:33 a.m.: This post has been updated to include statements from Purdue.
9:46 a.m.: This post was updated to include responses from the Justice Department and the FDA.
Purdue Pharma rejects request from New Hampshire attorney general for information on suspected diversion of OxyContin
August 26, 2016
The top law enforcement official in New Hampshire, a state ravaged by the opioid epidemic, accused the manufacturer of OxyContin on Friday of stonewalling demands for information the company collects about suspected criminal trafficking of its painkiller.
“They are just refusing to turn over documents,” state Atty. Gen. Joseph Foster said of drugmaker Purdue Pharma in an interview. “On one hand, they tell us they have nothing to hide and they are doing everything appropriately, but then why are they fighting so hard not to turn over this information?”
After a Times investigation last month exposed the extensive evidence Purdue’s internal security team gathers, and in many cases, does not share with law enforcement, state lawyers sent a subpoena directing the company to turn over any records related to New Hampshire. The Times found that the company’s confidential files include field reports, witness statements, prescribing data and surveillance photos on doctors and pharmacists across the nation suspected of catering to addicts and drug dealers.
In refusing to comply with the New Hampshire subpoena, Purdue cited longstanding objections to the state’s use of a private law firm in an ongoing investigation of the company and other opioid makers.
In court documents, company lawyers have said Purdue is willing to provide records to the attorney general and his lawyers, but on the condition they not share them with the private attorneys, who they have suggested have a financial incentive to wrest multimillion-dollar judgments from the company in civil suits.
“The Attorney General has repeatedly refused to accept the information we’ve offered to provide,” the company said in a statement.
James Boffetti, the senior assistant attorney general negotiating with Purdue, said he had agreed to limit access to the materials to government lawyers and investigators unless there was court approval of the use of private lawyers. But, he said, the company still declined. The conversations were “very frustrating,” he said, arguing that the information the state sought could help police identify criminal activity and stop prescription drugs from getting into the wrong hands.
“It’s just a knee-jerk response that doesn’t look at the bigger issue of public safety and harm,” Boffetti said.
New Hampshire, with a population of 1.3 million, has one of the nation’s highest rates of opioid prescribing and addiction, according to public health officials. Many addicted to painkillers have transitioned to abusing heroin, which is cheaper than pills, and overdoses and deaths have skyrocketed in recent years. A state report this summer called the opioid problem “one of the most significant public health crises” in the state’s history. There were 666 emergency room visits for opioid-related causes last month and, on average, nine people fatally overdose on drugs each week, according to state figures.
Government officials are fighting the crisis on many fronts, from outfitting police officers with naloxone, an anti-overdose drug, to starting new educational programs that begin warning children in kindergarten about the dangers of drugs. Foster said that after he took office in 2013, he was struck by the number of pills seized in raids on rural drug rings and decided to launch an investigation into whether fraudulent marketing of the drugs was contributing to their abuse.
The state has just a handful of attorneys to handle all consumer protection cases — from mortgage fraud to charity scams — and those lawyers are so busy that they rely on volunteers to take complaints. Foster decided to get outside help in the opioid investigation from a Washington, D.C., law firm, Cohen Milstein Sellers & Toll, that was already assisting the city of Chicago and two California counties sue drugmakers over the costs of the epidemic.
With the firm’s help, the attorney general’s office subpoenaed records from Purdue and four other drug companies related to the marketing of painkillers. But the companies fought the subpoenas, with their lawyers arguing that Cohen Milstein had “prejudged the merits of the investigation” and was “unduly influenced by the huge financial incentives” in a contingency arrangement that gave the firm 27% of a monetary judgment.
The companies repeatedly said they would produce the documents — potentially millions of pages — if they weren’t shared with the outside lawyers. The attorney general’s office saw this as an empty offer.
Courts have ruled that public agencies may use outside lawyers on a contingency basis as long as there are safeguards to ensure government officials remain in charge of the cases. Still, corporations have continued challenging their role. In New Hampshire, the legal wrangling over the private lawyers has gone on for a year. This spring, the state replaced the contingency agreement with the law firm with a flat-fee arrangement and decided to focus its investigation, at least initially, solely on Purdue. A Superior Court judge ruled earlier this month that the arrangement is permissible, but Purdue is currently appealing to the state Supreme Court.
David Vicinanzo, an attorney for Purdue, said in a statement that the state’s hiring of an outside firm raised “a very serious issue about whether it is proper for government enforcement powers to be privatized to outside counsel with a special financial interest.”
In July, The Times reported on the cache of evidence Purdue has about suspected criminal activity, using as an example an L.A. drug ring that the company did not report to authorities for years. The ring sent 1.1 million pills onto the black market. State lawyers in New Hampshire quickly sent a subpoena to Purdue.
“If we have those kind of things in our state, we would like to be able to take action on them,” Foster said.
Lawyers for Purdue filed a motion this month asking a judge to throw out the subpoena on several grounds, including the involvement of Cohen Milstein.
Citing The Times’ report, Foster and District of Columbia Atty. Gen. Karl Racine also asked the Drug Enforcement Administration last week to reduce national production quotas for oxycodone, the active ingredient in OxyContin, by a quarter. Under federal law, the DEA sets the amount of a controlled substance a manufacturer is allowed to produce.
“It makes little sense to entrust a manufacturer, such as Purdue, with an authorization to produce, and profit from, a narcotic drug when, seemingly, it is not meeting its legal obligations to report” abuse, they wrote.
A DEA spokeswoman said the agency “appreciates their concern on this vital subject. We take the quota-setting process very seriously and strive to provide for the country’s legitimate needs while also preventing the diversion of these potentially harmful medications.”
Purdue declined to comment on the letter.
California representatives call for congressional investigation into Purdue Pharma and other opioid makers
August 29, 2016
Two California representatives called Monday for a congressional investigation of opioid manufacturers, citing a Los Angeles Times investigation that found that the maker of OxyContin collected extensive evidence of criminal trafficking of its drug but in many cases did not alert law enforcement.
Rep. Mark DeSaulnier (D-Concord) and Rep. Ted Lieu (D-Torrance), both members of the House Oversight and Government Reform Committee, said in a letter to the committee chairs that an immediate investigation was necessary “to fully understand the implications and consequences of pharmaceutical companies that do not fulfill their legal and ethical requirements to restrict the sale of opioids in circumstances that raise suspicion regarding inappropriate prescribing practices.”
The congressmen added, “There appears to be a pervasive disregard for patient safety and public health by some within the pharmaceutical industry.”
The Times’ report last month concerned the workings of the internal security department of Purdue Pharma, a private Connecticut company that has reaped more than $31 billion from OxyContin, the nation's top-selling opioid painkiller. The newspaper found that, for a decade, company lawyers, investigators and other employees have used prescribing data, field reports, sales records and their own surveillance operations to identify doctors and pharmacies they suspected of catering to addicts and drug dealers. In many cases, the company did not share its information with the Drug Enforcement Administration or police or ensure its distributors cut off the supply of pills.
In one case highlighted by The Times, a criminal ring monitored by Purdue used a phony MacArthur Park clinic, elderly physicians and corrupt pharmacies to pump more than 1 million OxyContin tablets into the hands of gang members and other criminals. Purdue did not go to law enforcement until years later, when the ring was out of business and its leaders under indictment.
A spokesman for Purdue declined to comment. The company has said it complied with the law.
Since 1999, nearly 200,000 people in the U.S. have died of overdoses involving prescription painkillers. Stopping the crisis has attracted bipartisan support in Congress, including the recent passage of a law that would improve treatment programs and curb overdoses.
DeSaulnier, who is in his first term, has worked to address California’s prescription drug problem for several years. While serving in the state Senate in 2013, he wrote a law that improved the prescription monitoring program to allow authorities to better flag doctor-shopping patients and overprescribing physicians.
He said he was concerned that Purdue seemed to have escaped any repercussions for the way it handled the information it collected on suspect doctors and pharmacies.
“How do you get people to do the right thing when there are no consequences?” he said in an interview.
A U.S. senator on Friday called for federal investigations of OxyContin’s manufacturer in response to a Los Angeles Times report that found the bestselling painkiller wears off early in many patients, exposing them to increased risk of addiction.
Sen. Edward J. Markey, a Massachusetts Democrat whose state has been hit hard by prescription drug abuse, urged the Justice Department, the Food and Drug Administration and the Federal Trade Commission to launch probes of drugmaker Purdue Pharma.
OxyContin’s main selling point is that it lasts 12 hours. The Times investigation published this month found that when the effects don’t last, patients can suffer symptoms of narcotic withdrawal, including intense craving for the drug, and experience a cycle of agony and relief that experts say promotes addiction.
The newspaper found that Purdue had evidence of the problem for more than two decades, but continued to insist the drug lasted 12 hours, in part, to protect its revenue. OxyContin’s market dominance and premium price hinge on its 12-hour duration. Purdue instructed doctors who complained about the drug’s duration to prescribe stronger, but not more frequent, doses. Research shows that patients taking high doses of opioids are at greater risk of an overdose and death.
“These are serious allegations,” Markey wrote of The Times’ findings in a letter to Atty. Gen. Loretta Lynch. “They raise questions about ongoing deception by Purdue, harm to the public, continued costs to the United States, and the availability of further judicial recourse against Purdue…”
In a separate letter to the heads of the FDA and FTC, Markey called OxyContin “a leading culprit in the current opioid and heroin overdose epidemic.” More than 194,000 people have died from overdoses involving opioid painkillers since 1999 and abuse of those drugs is blamed for the resurgence in heroin addiction in the U.S. Markey said the agencies should “proactively warn prescribers, patients, and the general public” about problems the newspaper identified with OxyContin.
Purdue, a family-owned Connecticut company that has collected more than $31 billion from OxyContin sales, rejected The Times’ findings. In a statement, the company said Purdue shared Markey’s concerns about the opioid epidemic, but noted that the FDA approved OxyContin as a 12-hour drug.
“We promote our medicines only within the parameters approved by FDA and, given FDA has not approved OxyContin for eight-hour use, we do not recommend that dosing to prescribers,” the statement said.
A Justice Department spokesman said the department was reviewing the letter and an FTC spokesman confirmed the agency had received the letter, but declined comment.
An FDA spokeswoman said the agency was reviewing the letter and would respond directly to Markey. Previously, the agency spokeswoman told The Times the FDA “will revise labeling as necessary to improve proper prescribing and treatment,” but also placed responsibility with doctors.
“It should be well understood by physicians that there will be some individual variability in the length of time that patients respond to this drug,” the spokeswoman said.
Dr. Lewis Nelson, a New York University professor of emergency medicine who has advised the FDA on risks of prescription opioids, said that in his experience teaching physicians around the nation, many doctors have forgotten their medical school training about how opioids work in individuals.
“I don’t think the average doctor would recall the difference between changing a dose to q8,” medical shorthand for every 8 hours, “or increasing the dose,” Nelson said.
He said the Times findings were credible and the FDA “should change the label.”
“It would seem like this is a very fixable problem,” Nelson said.
OxyContin’s history is inextricably linked with the prescription drug epidemic. Purdue launched the drug in 1996 with an aggressive marketing campaign to primary care doctors that presented the painkiller as appropriate treatment for back aches and knee pain. Purdue and three company executives pleaded guilty in 2007 to federal charges of drug misbranding for what the company acknowledged was an attempt to downplay OxyContin’s risk of addiction. They were ordered to pay $635 million.
Markey has been an outspoken critic of the role of pharmaceutical companies and the FDA in the opioid crisis. In January, he temporarily blocked the nomination of Dr. Robert Califf as FDA commissioner to protest the agency’s approval process for opioids, including its August decision to approve OxyContin for use in children as young as 11. Califf was later confirmed.
“OxyContin is the original sin of the current opioid epidemic," Markey said in a statement to The Times. "For years, Purdue Pharma lied to federal regulators and the public about the addictiveness of OxyContin and countless patients got hooked on this deadly painkiller. We need to know if Purdue once again lied about the longevity of OxyContin’s pain-relieving properties and hold Purdue accountable."
Markey’s focus on opioids reflects Massachusetts’ severe problem with painkillers and heroin, which has been embraced by many prescription drug addicts as a cheaper alternative to pills. The death rate from opioid overdoses is more than twice the national average – and climbing. More than 1,300 people died from opioid-related causes last year, according to the Massachusetts Department of Public Health.
“Four people die every day and we haven’t been able to bend the trend,” said Marylou Sudders, the commonwealth’s secretary of health and human services. “That’s not a problem. That is a crisis.”
Sudders attributed the problem, in part, to doctors over-prescribing opioids. A state law passed in March requires doctors to receive additional training and limits first-time opioid prescriptions to seven days.
The Times report concerned an issue that went largely unnoticed in the scrutiny of OxyContin: the drug’s duration. Purdue’s clinical trials demonstrated the problem. In the first test on patients, for example, OxyContin wore off early in about half of participants.
After the drug hit the market, the company was confronted with additional evidence, including complaints from doctors and research by outside scientists.
In his letter to Lynch, Markey wrote that “if warranted” the Justice Department should try to recoup “taxpayer dollars that federal healthcare programs may have needlessly and unnecessarily spent on OxyContin prescriptions.”
U.S. surgeon general issues ‘a new call to action’ on addiction
Nov 17, 2016
When Dr. Vivek Murthy left his Massachusetts hospital to become U.S. surgeon general, the nurses who had known him since he was a resident had a parting plea: Do something about addiction.
On Thursday, Murthy tried to make good on that request with the release of a first-of-its-kind report calling for “a cultural shift in how we think about addiction.”
“For far too long, too many in our country have viewed addiction as a moral failing,” Murthy said in the report. “It is a chronic illness that we must approach with the same skill and compassion with which we approach heart disease, diabetes and cancer.”
The report comes at a time of great concern about addiction and uncertainty about how the Trump administration will respond to it. Drug overdoses have surpassed car accidents as a cause of death in recent years, a surge driven by the opioid epidemic. Prescription painkillers have killed more than 200,000 people since 1999 and their abuse has led to a resurgence in heroin addiction.
The 426-page report, titled “Facing Addiction in America,” was modeled on the 1964 surgeon general’s report on smoking and health, which first linked cigarettes to cancer and led to a successful national campaign against tobacco use.
Murthy described the report as “a new call to action.” It lays out recommendations for elected officials, the medical community, law enforcement and the public to improve the way addiction is treated.
More than 20 million Americans suffer from substance abuse disorders, far more than are diagnosed with cancer, but only about 10% receive treatment, according to the report. Murthy said that stigma surrounding addiction dissuades people from getting help and the report repeatedly referred to addiction as “a chronic brain disease.”
At a forum to highlight the report at the Studios at Paramount in Los Angeles, Murthy said that stigma surrounding addiction dissuades people from getting help. Some of the top government scientists studying addiction showed an audience of advocates, recovering addicts and family members brain scans that they said made clear addicts were suffering from a legitimate illness rather than moral weakness.
“Science tells us clearly that addiction is a disease of the brain,” Murthy said.
Many advocates had pinned their hopes on
“There’s no question we missed our best chance to revolutionize this space when Hillary Clinton lost,” said former Rep.
He said he was trying to give Trump the benefit of the doubt on addiction issues, noting that the president-elect lost his brother to alcoholism and that many voters who supported him come from states devastated by abuse.
“The hardest-hit sections of the country in the opiate crisis are red states,” Kennedy said.
In the run-up to the presidential primaries in New Hampshire and Iowa, areas reeling from opioid abuse, addiction was a central campaign issue with candidates sharing stories about family members and friends who were affected. The deeply divided Congress passed rare bipartisan legislation to address the opioid epidemic last year, but Republicans ultimately balked at President Obama’s request for a billion dollars of funding to implement the measures and the issue faded in the general election.
“We were really disappointed that the issue didn’t come up in any of the debates,” said Greg Williams, the co-founder of the nonprofit Facing Addiction, which is working with the surgeon general’s office.
He said Murthy’s report offers a road map for solving the problem and “the challenge is we have to find the public will to implement what we know can work.”
Contact the reporter | @latimesharriet
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