Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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"Abuse-Deterrent" Drugs Are Not the "Holy Grail" Pharma, i.e., Purdue, Claims It to Be

"Abuse-Deterrent" Drugs Are Not the "Holy Grail" Pharma, i.e., Purdue, Claims It to Be | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The pharmaceutical industry was listed as one of the “Contributors to the Current Crisis” in the final report of President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis. The report cites decades of aggressive marketing and industry-sponsored physician “conferences” aimed at expanding opioid use by minimizing the dangers of addiction. Lawsuits by state attorneys general, counties and local jurisdictions allege that the industry fostered the epidemic by overpromoting its products, while raking in billions as Americans became addicted and overdosed. “To this day,” the commission says, “the opioid pharmaceutical industry influences the nation’s response to the crisis.”

 

It sure does. In its response to an epidemic that now kills 50,000 Americans a year, the Trump administration wants to spend tens of millions of dollars in part to help the industry responsible sell ostensibly nonaddictive pain medications and “abuse deterrent” opioids that are as addictive as the original opioids.

 

Purdue executives call abuse-deterrent opioids, along with highly effective non-opioid pain products, the “holy grail” for the pharmaceutical industry.

 

“Abuse-deterrent is a marketing term used to mislead,” says Dr. Adriane Fugh-Berman, a pharmacology and physiology professor at Georgetown University who directs PharmedOut, a group that monitors pharmaceutical industry marketing efforts. “At least half of prescribers think that abuse-deterrent means less addictive.” It does not; abuse-deterrent pills are simply harder to crush or alter for injection or snorting. “It doesn’t prevent you from swallowing them, which is the most common way of abusing opioids,” Dr. Fugh-Berman said.

 

The N.I.H. began its public-private initiative this summer with a series of closed-door meetings with pharmaceutical companies and academics. An N.I.H. spokeswoman, Renate Myles, said the research would include work on non-pharmacological approaches, but “we need to develop new nonaddictive medications for pain. These medications can only be brought to market with the active participation of the pharmaceutical industry.”

 

Purdue participated in the N.I.H. initiative. In June, in response to a call for public comments, J. David Haddox, the company’s vice president for policy, sent a letter to the commission outlining Purdue’s proposed “policy options,” including recommending that the F.D.A. “convert” the opioid market to predominately abuse-deterrent formulations.

 

The commission’s report includes important recommendations like expanding Medicaid coverage for inpatient treatment; expanding treatment with buprenorphine, methadone and other medications, including some still being developed; establishing a national curriculum and standards for opioid prescribers; and expanding an alternative system of drug courts that encourage treatment. Those should be the immediate priorities, not channeling money for more meds to drug companies, from the pockets of Americans whose pain was the industry’s gain.

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johnmacknewtown's curator insight, November 11, 2017 9:04 AM
Pharmaceutical companies that produce and market opioids need to step up with funding for solutions to the opioid addiction crisis they "contributed to". I have some ideas regarding local programs that can benefit from such funding.
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The Pain in Maine = Purdue #Pharma, Doc Payments and Opiate Addiction

The Pain in Maine = Purdue #Pharma, Doc Payments and Opiate Addiction | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Today’s nationwide epidemic of opiate addiction was spawned in part by doctors who, with the best of intentions, wanted to help patients in pain, and by drug companies that said they had just the remedy – long-lasting, effective painkillers with none of the addictive qualities of their predecessors.

Hundreds of millions of prescriptions later, we know all three of those company claims to be false. Medications such as OxyContin have proved ineffective in treating the kind of chronic pain for which they are most often prescribed, and they have been widely successful at fostering addiction, setting the stage for the cheap and potent heroin that has devastated communities in every corner of the country.

Still, the companies that own these pain medications continue to push the old narrative, and still, they are finding friendly doctors to help them advance it.

And while it’s not surprising that companies are repeating what has worked when it comes to selling their products, it’s troubling that some doctors are so willing to go along.

Federal data analyzed by the Maine Sunday Telegram show that while policymakers and health and law enforcement officials were contending with an escalating opioid crisis, drug companies selling opioids were increasing payments and visits to doctors. Between August 2013 and December 2015, the bulk of all payments by prescription opioid manufacturers to doctors in Maine went to one physician, Doug Jorgensen of Manchester, who received $42,522. Another doctor received more than $13,000, while others received a few hundred dollars each.

These sorts of payments are legal, but they are discouraged by the Maine Medical Association and criticized by medical ethicists as a clear conflict of interest. Even small payments, they say, can affect – subconsciously even – what a doctor ultimately prescribes, a decision that should be guided by medical knowledge and patient needs, not whether a pharmaceutical company bought a doctor dinner.

The report follows a Los Angeles Times investigation showing how Purdue Pharma, the company behind OxyContin, is reacting to a 40 percent drop in prescriptions for that drug since 2010. Purdue, the Times reports, is trying to open new markets across the globe, using paid-off doctors to pitch the same script it used in the U.S., overselling the benefits and downplaying the risks of opiate medication (read "The Pain in Spain: OxyContin Sales Shrink in U.S., So Purdue #Pharma Goes Global!": http://sco.lt/8LFSuv).

Those countries will find out soon what most Americans know now.

 

Further Reading:

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The Pain in Spain: OxyContin Sales Shrink in U.S., So Purdue #Pharma Goes Global!

The Pain in Spain: OxyContin Sales Shrink in U.S., So Purdue #Pharma Goes Global! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

With the nation in the grip of an opioid epidemic that has claimed more than 200,000 lives, the U.S. medical establishment is turning away from painkillers. Top health officials are discouraging primary care doctors from prescribing them for chronic pain, saying there is no proof they work long-term and substantial evidence they put patients at risk.

 

Prescriptions for OxyContin have fallen nearly 40% since 2010, meaning billions in lost revenue for its Connecticut manufacturer, Purdue Pharma.

 

So the company’s owners, the Sackler family, are pursuing a new strategy: Put the painkiller that set off the U.S. opioid crisis into medicine cabinets around the world.

 

A network of international companies owned by the family is moving rapidly into Latin America, Asia, the Middle East, Africa and other regions, and pushing for broad use of painkillers in places ill-prepared to deal with the ravages of opioid abuse and addiction.

 

In this global drive, the companies, known as Mundipharma, are using some of the same controversial marketing practices that made OxyContin a pharmaceutical blockbuster in the U.S.

 

The Pain in Spain

Seeking new patients in Spain, Mundipharma chose ambassadors guaranteed to attract attention: Naked celebrities.

 

A string of topless actors, musicians and models looked into the camera and told fellow Spaniards to stop dismissing aches and pains as a normal part of life.

 

“Don’t resign yourself,” Maria Reyes, a model and former Miss Spain, said in the 2014 television spot.

 

“Chronic pain is an illness in and of itself,” the pop singer Conchita added.

 

The one-minute ad was part of a nationwide campaign developed and financed by Mundipharma to raise awareness of chronic pain — Rebélate contra el dolor (Rebel against the pain).

 

Further Reading:

  • “Purdue #Pharma Doesn't Want Court to Unseal Oxycontin Marketing Documents. What's It Hiding?”: http://sco.lt/6wb24f
  • “OxyContin's 12-hour Problem: Misrepresentation of Efficacy Leads to Addiction & Purdue Knew It”: http://sco.lt/8RfD5F
  • “The History of Purdue's Marketing of Oxycontin & Its Connection to the Opiate Epidemic”: http://sco.lt/6RajLd
Pharma Guy's insight:

I couldn't find the Spanish ad featuring topless celebrities mentioned in this article. :(

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Aimee Washington's curator insight, July 8, 5:16 PM
Ryan, Harriet, et al. “OxyContin Goes Global - ‘We're Only Just Getting Started.’” Los Angeles Times, Los Angeles Times, www.latimes.com/projects/la-me-oxycontin-part3/.

The graph shown above shows that Oxycontin sales increased and decreased over time. Family doctors have started to turn away from chronic pain medications. They have started to refer patients out to pain management doctors that can give the patient an injection in the site where the pain is, or give pain medications, but they monitor them closely. Oxycontin sales have dropped over time in the US so now Purdue Pharma has expanded globally to other countries. The countries are not prepared to deal with an opioid crisis, just like the US was not prepared. international companies named  Mundipharma has started targeting other regions globally.  Mundipharma is aggressively advertising pain medicine to  international places to make revenue since they are no longer making a substantial amount of money in America. Mundipharma developed an advertisement for pain medications with naked women and celebrities to bring in revenue. This is to promote chronic pain medications.  The target audience would be the general public for public knowledge on Oxycontin sales. The interest of the article would be geared towards pharmaceutical companies explaining that purdue is expanding internationally.
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Iraq War Veteran Lawmaker Calls for Scrutiny of Purdue Pharma's Role in Opioid Abuse Epidemic

Iraq War Veteran Lawmaker Calls for Scrutiny of Purdue Pharma's Role in Opioid Abuse Epidemic | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Congress showed bipartisan support for legislation to address the nation's opioid abuse epidemic, a lawmaker urged colleagues Thursday to look closely at the role of pharmaceutical companies, citing a Los Angeles Times investigation into the manufacturer of OxyContin.

 

In remarks on the House floor, Rep. Tulsi Gabbard (D-Hawaii) called the marketing of painkillers by drug companies "the root cause of the problems."

 

She pointed to The Times investigation, which found that OxyContin, sold as a 12-hour drug, wears off early in many patients, exposing them to increased risk of addiction. Drugmaker Purdue Pharma, which has reaped $31 billion from the painkiller, had evidence of the duration problem for decades, but continued telling doctors it lasted 12 hours, in part to preserve revenues, The Times found.

 

"The problems created by companies like Purdue are felt deeply by families all across our country," said Gabbard, an Iraq war veteran who has endorsed Democratic presidential candidate Bernie Sanders.

 

"Opioid abuse and addiction is one of our top national health challenges, and that's why for more than a decade Purdue Pharma has undertaken efforts to help address this crisis," the company said.

 

[Meanwhile, Purdue also said it “looks forward” to appealing a Kentucky court ruling to release secret documents about the marketing of the potent pain pill OxyContin (read “Judge Orders Release of Secret Purdue #Pharma OxyContin Marketing Documents - But Don't Hold Your Breath!”; http://sco.lt/4kfBNB)]

 

"We've seen for decades that major pharmaceutical companies have misled the FDA, doctors and patients about the safety and risks of opioid dependency … in their efforts to sell more drugs," Gabbard said.

 

Her remarks came as the House passed a bundle of bills to stem the opioid crisis. More than a dozen drug-related bills approved this week parallel similar legislation advanced in the Senate. In both chambers, the legislative effort has garnered bipartisan support. Congressional Republicans, particularly lawmakers facing tough reelection fights this fall, have trumpeted their response to the epidemic.

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OxyContin's 12-hour Problem: Misrepresentation of Efficacy Leads to Addiction & Purdue Knew It

OxyContin's 12-hour Problem: Misrepresentation of Efficacy Leads to Addiction & Purdue Knew It | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The drugmaker Purdue Pharma launched OxyContin two decades ago with a bold marketing claim: One dose relieves pain for 12 hours, more than twice as long as generic medications.

 

Patients would no longer have to wake up in the middle of the night to take their pills, Purdue told doctors. One OxyContin tablet in the morning and one before bed would provide “smooth and sustained pain control all day and all night.”

 

When Purdue unveiled OxyContin in 1996, it touted 12-hour duration.

 

On the strength of that promise, OxyContin became America’s bestselling painkiller, and Purdue reaped $31 billion in revenue.

But OxyContin’s stunning success masked a fundamental problem: The drug wears off hours early in many people, a Los Angeles Times investigation found. OxyContin is a chemical cousin of heroin, and when it doesn’t last, patients can experience excruciating symptoms of withdrawal, including an intense craving for the drug.

 

The problem offers new insight into why so many people have become addicted to OxyContin, one of the most abused pharmaceuticals in U.S. history.

 

The Times investigation, based on thousands of pages of confidential Purdue documents and other records, found that:

 

  • Purdue has known about the problem for decades. Even before OxyContin went on the market, clinical trials showed many patients weren’t getting 12 hours of relief. Since the drug’s debut in 1996, the company has been confronted with additional evidence, including complaints from doctors, reports from its own sales reps and independent research.
  • The company has held fast to the claim of 12-hour relief, in part to protect its revenue. OxyContin’s market dominance and its high price — up to hundreds of dollars per bottle — hinge on its 12-hour duration. Without that, it offers little advantage over less expensive painkillers.
  • When many doctors began prescribing OxyContin at shorter intervals in the late 1990s, Purdue executives mobilized hundreds of sales reps to “refocus” physicians on 12-hour dosing. Anything shorter “needs to be nipped in the bud. NOW!!” one manager wrote to her staff.
  • Purdue tells doctors to prescribe stronger doses, not more frequent ones, when patients complain that OxyContin doesn’t last 12 hours. That approach creates risks of its own. Research shows that the more potent the dose of an opioid such as OxyContin, the greater the possibility of overdose and death.
  • More than half of long-term OxyContin users are on doses that public health officials consider dangerously high, according to an analysis of nationwide prescription data conducted for The Times.
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The History of Purdue's Marketing of Oxycontin & Its Connection to the Opiate Epidemic

The History of Purdue's Marketing of Oxycontin & Its Connection to the Opiate Epidemic | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Between physician databases, incentive-happy sales reps, and an aggressive blitz package of promotional ephemera, Purdue's multifaceted marketing campaign pushed OxyContin out of the niche offices of oncologists and pain specialists and into the primary care bazaar, where prescriptions for the drug could be handed out to millions upon millions of Americans. The most scathing irony is that what allowed OxyContin to reach so many households and communities was the claim that it wasn't dangerous.


Whatever the gray areas on OxyContin's many paths to perdition, the statistics on the first decade of this century bear out a staggering epidemic. From 1999 to 2010, the sale of prescription painkillers to pharmacies and doctors' offices quadrupled. In the exact same time span, the number of overdose deaths from prescription painkillers also quadrupled, rising to almost 17,000.


To call this a coincidence would be analogous to declaring no connection between loosening enforcement on drunk driving laws and observing a sudden increase in deaths caused by drunk driving. It goes almost without saying that these figures dovetail seamlessly with the release of OxyContin and Purdue's marketing timeline, which hit hardest in the early 2000s.

Pharma Guy's insight:


Meanwhile, FDA, in its quest to approve more and more drugs and despite no votes from its advisory committee, continues to approve powerful addictive painkillers such as Zohydro, "an opioid so powerful that a single dose could kill a child," according to Public Citizen, is the most recent.

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Purdue Lawyers Up: Says Public "Has No Right Whatsoever" to See "Secret' Documents About Oxycontin Marketing

Purdue Lawyers Up: Says Public "Has No Right Whatsoever" to See "Secret' Documents About Oxycontin Marketing | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A state appeals court Monday heard arguments over whether secret records regarding the marketing of the powerful prescription opioid OxyContin should be released to the public.

A three-judge panel of the Kentucky Court of Appeals is considering a request from OxyContin maker Purdue Pharma to overturn a lower court ruling ordering the release of the documents — the result of a motion filed by STAT. The records include a deposition of Dr. Richard Sackler, a former president of Purdue and a member of the family that owns the privately held Connecticut company.

 

Lawyers for Purdue and STAT made their arguments during a 30-minute hearing, interrupted occasionally by questions from presiding Judge Glenn Acree. At the end, he said the panel would try to issue a ruling within 30 to 45 days.

 

Much of the hearing focused on a key question: Did Pikeville Circuit Court Judge Steven D. Combs, who ruled last year that the records should be unsealed, have discretion to release documents that the two parties to the case — Purdue and the state of Kentucky — had agreed to keep secret.
 

The records were filed as part of a lawsuit brought by the state against Purdue alleging that the marketing of OxyContin helped create a wave of addiction and related crime. That case was settled in December 2015, with Purdue making a $24 million payment to the state.

 

Jon Fleischaker, a Louisville lawyer representing STAT, said trial courts in Kentucky have great discretion to open their files. “This is more than a private dispute resolution,” he argued, noting that the public has a right to know what went into the settlement between the state and the drug company. “How did the court behave? How did the attorney general behave? Was it settled for too little or too much? You’re dealing with public offices and public trust in the system.”

 

His comment came in response to a question from Acree about the extent to which a trial judge is obligated to honor an agreement between lawyers that documents will be kept secret.

 

Purdue’s lawyer, Daniel Danford of Lexington, Ky., said there was no common right of law “to pry into affairs of individual litigants.” He added that “merely filing a document does not make it public.” The key, he said, was whether it’s a “judicial document” — one that the court relied on in making its rulings in the case. Most of the documents were filed in court by the Kentucky attorney general to support motions made before the suit was settled, and Purdue has argued that none of those motions were ruled on by the trial court.

 

“The public has no right of access to them whatsoever,” Danford said.

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The DEA-Pain Pill Pharma Revolving Door

The DEA-Pain Pill Pharma Revolving Door | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Pharmaceutical companies that manufacture or distribute highly addictive pain pills have hired dozens of officials from the top levels of the Drug Enforcement Administration during the past decade, according to a Washington Post investigation.

 

The hires came after the DEA launched an aggressive campaign to curb a rising opioid epidemic that has resulted in thousands of overdose deaths each year. In 2005, the DEA began to crack down on companies distributing inordinate numbers of pills such as oxycodone to pain-management clinics and pharmacies around the country.

 

Drug Enforcement Agency personnel arrest a suspect in San Diego, Calif. As the agency has expanded enforcement to address the nation's opioid epidemic, drug companies have been hiring away former top-level DEA officials for their expertise.

Drug Enforcement Agency personnel arrest a suspect in San Diego, Calif. As the agency has expanded enforcement to address the nation's opioid epidemic, drug companies have been hiring away former top-level DEA officials for their expertise. Reuters/Mike Blake

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Since then, the pharmaceutical companies and law firms that represent them have hired at least 42 officials from the DEA – 31 of them directly from the division responsible for regulating the industry, according to work histories compiled by The Washington Post and interviews with agency officials.

 

The number of hires has prompted some current and former government officials to question whether the companies raided the division to hire away DEA officials who were architects of the agency’s enforcement campaign or were most responsible for enforcing the laws the firms were accused of violating.

 

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Further Reading:

 

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Purdue #Pharma Doesn't Want Court to Unseal Oxycontin Marketing Documents. What's It Hiding?

The maker of the pain pill OxyContin filed an appeal on Monday of a Kentucky judge’s decision to unseal records related to how the drug was marketed and what company officials knew about the addictive properties of the potent opioid.

The notice of appeal by Purdue Pharma, filed in Pike Circuit Court in eastern Kentucky, triggered the beginning of the appeals process and did not contain any legal arguments challenging the judge’s decision. After a month to six weeks of procedural matters, it is expected both sides will begin arguing the case in briefings to the Kentucky Appeals Court. That process could take up to five months. The appeals court, consisting of three judges, will then decide to either conduct oral arguments on the case or rule on the matter based only on the briefings.

 

Meanwhile, “Secret Internal Sales Documents Reveal Abbott's Despicable ‘Crusade’ to Sell OxyContin”; http://sco.lt/71CKvZ

Pharma Guy's insight:

You might also like to read these:

 

Judge Orders Release of Secret Purdue #Pharma OxyContin Marketing Documents - But Don't Hold Your Breath!; http://sco.lt/4kfBNB

 

Iraq War Veteran Lawmaker Calls for Scrutiny of Purdue Pharma's Role in Opioid Abuse Epidemic; http://sco.lt/8HgsU5

 

OxyContin's 12-hour Problem: Misrepresentation of Efficacy Leads to Addiction & Purdue Knew It; http://sco.lt/8RfD5F

 

The History of Purdue's Marketing of Oxycontin & Its Connection to the Opiate Epidemic; http://sco.lt/6RajLd

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Judge Orders Release of Secret Purdue #Pharma OxyContin Marketing Documents - But Don't Hold Your Breath!

Judge Orders Release of Secret Purdue #Pharma OxyContin Marketing Documents - But Don't Hold Your Breath! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Secret documents about the marketing of the potent pain pill OxyContin will be unsealed next month under an order issued Wednesday by a Kentucky judge.

STAT filed a motion in March to unseal the records in Pike Circuit Court in Kentucky. They include the deposition of Dr. Richard Sackler, a former president of OxyContin maker Purdue Pharma and a member of the family that owns the privately held Connecticut company.

OxyContin has been blamed by many for helping to ignite the scourge of opioid abuse in the United States that began with prescription painkillers and has progressed to heroin and fentanyl.

“The court sees no higher value than the public (via the media) having access to these discovery materials so that the public can see the facts for themselves,” Judge Steven Combs said in his ruling.

He ordered that the documents be unsealed in 32 days, which would be June 12. He said he would stay the release of the records if any party files an appeal before then.

 

“The national opioid epidemic is killing 30,000 people a year, and we are pleased that the court moved so swiftly to bring to light records that can inform the public’s understanding of Purdue’s role in this crisis,” said Rick Berke, STAT’s executive editor. “We see pursuit of this story as integral to STAT’s central mission to hold institutions and individuals accountable.”

Purdue’s chief litigation counsel, Richard Silbert, said in a statement, “We look forward to appealing this ruling.”

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"What's Your Role in Preventing Opioid Abuse?," Asks Purdue Pharma

"What's Your Role in Preventing Opioid Abuse?," Asks Purdue Pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Purdue Pharma L.P. proudly introduces Team Against Opioid Abuse, a new website designed to help healthcare professionals and laypeople alike learn about different abuse-deterrent technologies and how they can help in the reduction of misuse and abuse of opioids. Combating misuse and intentional abuse of prescription pain relievers involves more than just the person holding the prescription pad. It is a team effort, including pharmacists, nurses, counselors, caregivers, patients, and payers, both public- and private-sector. Public health experts have stated that Opioids with Abuse-Deterrent Properties (OADP) are an essential component of a comprehensive, evidence-based strategy to reduce opioid abuse that requires coordinated and sustained efforts from the healthcare team along with multiple other players, such as manufacturers, policymakers, regulators, educators, and law enforcement.


"Education about the proper use of opioid analgesics is a top priority at Purdue Pharma. Everyone on the team should understand their role and responsibilities, so they can do their part in combating abuse of opioids, while ensuring their availability for appropriate purposes," said J. David Haddox, DDS, MD, Vice President, Health Policy, Purdue Pharma L.P. "Opioids with Abuse-Deterrent Properties are one tool to help the team in their efforts in fighting drug abuse. We developed this website to inform everyone who influences how drugs are prescribed, taken, stored, and destroyed, when no longer needed."

Pharma Guy's insight:

Also read "The History of Purdue's Marketing of Oxycontin & Its Connection to the Opiate Epidemic"; http://sco.lt/6RajLd 

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