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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Crisis in $12B U.S. Opioids Market? From Cannabis?

 

The U.S. opioids market was valued at US$ 12,046.3 million in 2015 and is expected to witness a moderate CAGR of 5.2% during the forecast period (2016–2024).

 

According to the New York Times analysis of state data, in 2016, drug overuse led to death of 59,000 to 65,000 people in the U.S. and majority (about two-third) of death were due to opioids overuse and this number is witnessing an increase. According to a survey of National Institute of Drug Abuse (NIDA), deaths due to the overdose prescription of opioid pain relievers have more than tripled in the past 20 years, escalating to 16,651 deaths in the U.S. in 2010. It can be concluded from the analysis of the data (data from the survey and New York Times data), that death due to opioids have more than doubled in the past six years.

 

In October 2016, though the Government of the U.S. declared opioids crisis as an emergency. The declaration is expected to help in increasing awareness among the public about overuse of opioids. It would also make doctors and pharmacy stores hesitant to over-prescribe or overstock opioids. The government has approached leading pharmacy chains, insurance companies, and others, for cooperation. For instance, Attorney General of over 35 states sent a letter to the America’s Health Insurance Plans, national association whose members provide coverage for health care and related services, urging its members to reconsider coverage policies that may be fueling the opioid crisis in October 2017. Such measures can ensure proper usage of opioids and favors the market players in the U.S. opioids market.

 

 

Increasing incidences of chronic pain is expected to drive growth of the U.S. opioids market

According to the American Academy of Pain Medicine (AAPM), 2011, around 1.8 billion people suffered from chronic pain. Moreover, according to the National Institute of Health (NIH) estimates in 2015, one in 10 people in the U.S. suffered from chronic pain. Increasing prevalence of chronic pain is expected to result in high prescription of opioids pain relievers, which in turn is expected to fuel the market growth. Easy availability and favorable insurance policy are other major drivers for growth of the U.S. opioids market.

 

The analysis of Medicare prescription drug plans, which covers 35.7 million people in the second quarter of 2017, by ProPublica — an investigative journal and The New York Times — a leading U.S. newspaper, revealed that only one-third of the covered people had any access to other types of pain killer and less-risky opioids. This was attributed to low cost of opioids drugs. The scenario might change, however, due to strict monitoring from government and regulatory bodies. 

 

Cannabis as potential alternative for pain relief can be a threat to the U.S. opioids market

Cannabis could be the alternative therapy for opioids. Currently, medical marijuana is legal in 28 states and the District of Columbia even though it is illegal under federal law. According to a research published in Annals of Internal Medicine, in majority of cases, between 45% and 85%, medical marijuana is used for pain management. However, there is some ambiguity about medical marijuana effectiveness in pain management. Cannabis could be used as effective therapy after establishment of clinical trials. 

Some major players operating in the U.S. opioids market include Purdue Pharma L.P., Titan Pharmaceuticals, Inc., Boehringer Ingelheim GmbH, Janssen Pharmaceuticals, Inc., Sanofi S.A., Sun Pharmaceuticals Industries Limited, Mallinckrodt Pharmaceuticals, Egalet Corporation, Endo Pharmaceuticals plc, Allergan, plc, and Pfizer Inc.

 

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Heads Up! Migraine Drug Ads Soon May Give Millions Headaches!

Heads Up! Migraine Drug Ads Soon May Give Millions Headaches! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Four major pharmaceutical companies are in a race to be the first to offer a drug that may rapidly reduce—and even prevent—migraines to the more than 38 million Americans affected by the debilitating illness each year.

Alder Biopharmaceuticals, Eli Lilly, Amgen and Teva Pharmaceutical have all developed migraine drugs which have completed or are currently undergoing Phase 3 clinical trials using a compound called calcitonin gene-related peptide (or CGRP) that contains antibodies that attack the protein in the brain that causes the severe headaches.

“All four anti-CGRP trials currently underway by the separate companies are positive, showing very promising efficacy for patients and good safety profiles so far. In terms of timing, Amgen’s drug is currently on track to be the first available to patients,” Carl Cincinnato, director of Quantified Health and The Migraine World Summit, told FOX Business.

According to the Migraine Research Foundation, the illness is the 3rd most prevalent—and the 6th most disabling—in the world and affects 12% of the U.S. population, including children. Women and children are impacted the most at 18% and 10%, respectively, while men make up just 6% of the population.

Pharma Guy's insight:

First, If all 4 of these biological drugs hit the market at the same time, there is sure to be a barrage of DTC ads competing to gain market share.

 

Second, these drugs are sure to be super expensive!

 

Third, if only 6% of men suffer from Migraines vs. 18% of women, why did this news report show the image of a man suffering from Migraine - I'm sure the image was picked up from a PR packet supplied by one of the four companies mentioned.

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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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Pain Pill Advocates Defend Opioid-Induced Constipation Super Bowl Ad. We're Not Junkies!

Pain Pill Advocates Defend Opioid-Induced Constipation Super Bowl Ad. We're Not Junkies! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Next to the game itself, probably the one thing people talk about the most to day after the Super Bowl are the TV commercials. 


One commercial that is making quite a few lists as one of the worst is by drug maker AstraZeneca promoting its opioid induced constipation (OIC) drug. The black and white commercial features a constipated man envious of others (even a dog) who can easily go to the bathroom.


“The Super Bowl is known for inspiring lots of eating and lavish spreads of food. So why would advertisers pay millions to air ads focusing on constipation?” asked Eric Deggans of National Public Radio.  “There may never be a great time to air ads like this, but to broadcast such spots in an event where viewers are eating stuff like guacamole dip and pizza surely is the worst.”


“Nothing livens up a Super Bowl like a commercial about opioid-induced constipation,” said ESPN’s Dan Graziano on Twitter. 

“Opioid Induced Constipation commercial during the Superbowl? Should have aired that during the Pro Bowl. Nobody gives a sh** about it,” wrote Don on Twitter. 


Most of the Tweets aimed for laughs, but one by comedian and talk show host Bill Maherquickly went viral – and not because most people thought it was funny.


“Was that really an ad for junkies who can’t sh**? America, I luv ya but I just can’t keep up,” wrote Maher.


The depiction of opioid patients as “junkies” really got under the skin of pain sufferers and patient advocacy groups, some of whom are sponsored by AstraZeneca.

Pharma Guy's insight:

I also got this email from Paul Gileno, Founder & President, U.S. Pain Foundation:


Bill Maher single-handedly labeled all people with pain as junkies. I take extreme offense to this statement. It is this ignorant mindset that is harming the 100 million Americans living with pain from receiving the adequate care they need as well as the support they deserve. In the current health care landscape, chronic pain patients are continually forced to "prove" their pain. They face backlash and ridicule instead of compassion and help.
 
U.S. Pain Foundation collaborated on this ad with other organizations to spread awareness and information. The intention was to provide hope and resources to those facing a serious condition brought on by following a legitimate treatment program. The goal - for all involved on this project - was to make sure people living with OIC do not feel embarrassed or alone. It therefore saddens and angers me that those with high profiles would choose to increase the stigma associated with chronic pain without researching the pain care crisis in America.
 
Mr. Maher, let me inform you:
  • According to the 2011 IOM Report, 100 million Americans live with chronic pain caused by many different illnesses, conditions or injuries.
  • Chronic pain affects all races, religions, sexes and ages. 
  • In 2015, The National Pain Strategy incorporated these four core beliefs from the Consumer Pain Advocacy Task Force into their plan.
    1. Chronic pain is a real and complex disease that may exist by itself or be linked with other medical conditions.
    2. Chronic pain is both an under-recognized and under-resourced public health crisis with devastating personal and economic impact.
    3. Effective chronic pain care requires access to a wide range of treatment options, including biomedical, behavioral health and complementary treatment.
    4. Denying appropriate care to people with chronic pain is unethical and can lead to unnecessary suffering, depression, disability and even suicide.
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Opioid Epidemic Getting Worse Due to FDA, Which Now Says It Will Change Its Ways

Opioid Epidemic Getting Worse Due to FDA, Which Now Says It Will Change Its Ways | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Under pressure to stop the US epidemic of opioid abuse and related deaths, the Food and Drug Administration on Thursday launched a plan to toughen warning labels, improve treatment of both addiction and pain, and expand the use of abuse-deterrent medications.


“We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” said Dr. Robert Califf, the FDA’s Deputy Commissioner for Medical Products and Tobacco, in a statement.


“Things are getting worse, not better [Duh!], with the epidemic of opioid misuse, abuse, and dependence. It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”


The timing may be fortuitous for Califf. The former Duke University physician-scientist was nominated by President Barack Obama to head the FDA last September, but his confirmation has run into roadblocks in the Senate.


Two of the four senators vowing to block or filibuster a confirmation vote have expressed concern over the FDA’s policies on opioids. Both Edward Markey of Massachusetts and his Democratic colleague Joe Manchin of West Virginia have criticized the agency for not doing more to address the nationwide epidemic. 


Last month, Markey, said he was especially troubled that the FDA approved OxyContin for children in 2015 without first convening an expert advisory panel, as the agency often does, while Manchin took issue with Califf’s ties to the drug industry, including companies that make opioids.


Pharma Guy's insight:

Some pain specialists, which FDA plans to consult on a solution, and most drug makers, say the solution is not necessarily fewer drugs but better ones — a new generation of opioids with physical or chemical features to drive down improper consumption. Read "Pharma Challenged to Develop Better Pills for Pain, But 'Beyond the Pill' is Bigger Challenge"; http://sco.lt/5By5Mf and "FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics"; http://1.usa.gov/1LSI6Yd

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Pharma Guy's curator insight, March 31, 2016 7:49 AM

Some pain specialists, which FDA plans to consult on a solution, and most drug makers, say the solution is not necessarily fewer drugs but better ones — a new generation of opioids with physical or chemical features to drive down improper consumption. Read "Pharma Challenged to Develop Better Pills for Pain, But 'Beyond the Pill' is Bigger Challenge"; http://sco.lt/5By5Mf and "FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics"; http://1.usa.gov/1LSI6Yd

Behavioral Health Network Resources's comment, May 28, 2016 12:35 PM
Did Political Agenda Plant Seed for Opioid Addiction Epidemic https://www.linkedin.com/pulse/did-political-agenda-plant-seed-opioid-addiction-epidemic-davis?published=t Pls Share
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Pharma Challenged to Develop Better Pills for Pain, But "Beyond the Pill" is Bigger Challenge

Pharma Challenged to Develop Better Pills for Pain, But "Beyond the Pill" is Bigger Challenge | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Increasing abuse of painkillers in the US is putting the industry under pressure to make the drugs tamper-proof


The US drugs watchdog recently declared opioid abuse in America to be a national epidemic, claiming an average of 45 lives through overdose each day. Eighty per cent of heroin addicts say they first became addicted to opioid prescription painkillers, both of which are cleaved from the “joy plant”.


Dealing with the crisis has become the subject of a fierce debate in the American medical establishment. On one side are those doctors who believe their profession has spent decades overprescribing opioids, helping patients pursue zero pain while unwittingly pushing many of them to addiction. In supporting their case for sharp curbs on prescriptions, this group points to statistics showing that US opioid distribution on a measure known as “morphine equivalent milligrams” soared from 25.3 per person per year in 1980 to 550.7 by 2012.


“It can be traced to a period of over-prescribing of opioid analgesics by providers and physicians,” argues Adrienne Abbate, who runs a charity to tackle opioid abuse in New York. “Pharmaceutical companies aggressively marketed to physicians, and made it seem as if it would be a safe and non-addictive form of pain treatment.”


Others in the medical establishment, including some pain specialists and most drug makers, say the solution is not necessarily fewer drugs but better ones — a new generation of opioids with physical or chemical features to drive down improper consumption.


Pharma Guy's insight:

But the solution goes "beyond the pill" in that physicians must be re-educated about the dangers of pain medications. Read, for example, 

"FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics"; http://1.usa.gov/1LSI6Yd 

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Is There a Role for Medical Cannabis in Combating the Opioid Epidemic?

Is There a Role for Medical Cannabis in Combating the Opioid Epidemic? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The current opioid epidemic is forcing many physicians to reevaluate their use of prescription opioids for pain control and to consider alternative pain management strategies. There is an emerging body of evidence that suggest that medical cannabis (smoked, vaporized or ingested) can effectively manage and control chronic non-cancer pain, reduce opioid consumption and help to lower opioid overdose deaths.

While cannabis is not approved as a treatment for pain in the US, there is a growing body of evidence from states where medical cannabis is legal that cannabis reduces opioid consumption in chronic pain patients. Several studies in the US and around the world showed that opioid use dropped by as much as 50% among chronic pain patients when they were given access to cannabis.

 

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Pharma Guy's insight:

Guest post by Cliff Mintz who writes for Cannabis Science Blog.

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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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Wow! #Pharma Sales Rep & Paid Physician Paramour‎ Hatch Pain Med Kickback Scheme

Wow! #Pharma Sales Rep & Paid Physician Paramour‎ Hatch Pain Med Kickback Scheme | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A former sales manager for Insys Pharmaceuticals, which manufactures a highly addictive painkiller (Sunsys Fentanyl - 100X more powerful than morphine) and is under investigation in multiple U.S. states, has pleaded guilty to charges of fraud.


Former Insys sales manager Natalie Reed Perhacs recently pleaded guilty to conspiracy to commit health care fraud including engaging in kickback schemes in the United States District Court for the Southern District of Alabama (Southern Division). 


Insys was the subject of a CNBC investigation in November which revealed that two physicians in Mobile, Alabama, Dr. Xiulu Ruan and Dr. John Couch, partners at a practice, received over $210,000 from Insys Therapuetics in 2013 and 2014 for things like speaking fees, travel and meals.


The agreement with the Insys sales rep, filed on Feb. 17 and obtained by CNBC, states that Perhacs was hired by Insys as a kickback to Dr. Ruan, who became fond of her and "went out of his way" to try to get her hired as a sales representative with a pharmaceutical company. 


In an e-mail sent on November 7, 2012, Dr. Ruan asked Perhacs,"Well, I want to ask you a personal question and hopefully you would not be offended. Are you involved with someone now? . . . You don't have to answer any of these if you do not feel comfortable."


The plea agreement states that Perhacs was not hired because of her knowledge or experience working with controlled substances like Subsys; but rather, she was hired to "induce, and in exchange for, Dr. Ruan continuing to prescribe Subsys."


"Perhacs had a strong financial incentive to do so, and to turn a blind eye to illegal kickbacks being paid by Company A [Insys] to Dr. Ruan and Dr. Couch. Despite earning a base salary of only $40,000.00 per year, commissions from off-label prescriptions written by Dr. Ruan and Dr. Couch resulted in Perhacs making over $700,000.00 between April 2013 and the doctors' arrests on May 20,2015."

Pharma Guy's insight:

Of course, this is not typical of mainstream Big Pharma.

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Senator Scrutinizes #Pharma Links on Government Pain Panel

A high-ranking Senate Democrat is scrutinizing links between pharmaceutical companies and government advisers who recently criticized efforts to reduce painkiller prescribing.


Sen. Ron Wyden says he has "a number of concerns" about how panelists were selected and screened for an advisory panel on pain issues that includes government experts, outside academics and patient advocates. Wyden's inquiry follows a recent Associated Press story that found nearly a third of panelists at a December meeting of the Interagency Pain Research Coordinating Committee had apparent financial ties to painkiller manufacturers, including the maker of OxyContin.


"These financial and professional relationships raise serious concerns about the objectivity of the panel's members that deserve additional review," Wyden writes in a letter Monday to the head of the Department of Health and Human Services.


The panel attracted attention late last year after several members bashed a federal plan to recommend doctors reduce their prescribing of painkillers for chronic pain. The draft guidelines by the Centers for Disease Control and Prevention are intended to curb deadly overdoses tied to powerful but highly-addictive opioid drugs, including Percocet and Vicodin. Opioid painkillers and heroin — which is also part of the opioid family — caused 28,650 fatal overdoses in 2014, the highest number ever in the U.S.


Since coming under criticism from the panel, the CDC has re-opened its guidelines to additional public comment and review.

In his letter, Wyden states that the law creating the federal pain panel "makes no provision that representatives of the pharmaceutical industry are included on the panel."


Yet several non-federal members — through their organizations or directly — have received funding from painkiller makers, Wyden notes.

Pharma Guy's insight:

Also read: "Federal Pain Panel That Bashed Anti-Oxycontin Over Rx Plan, Rife with Links to #pharma"; http://sco.lt/4i76mn

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Drug Overdose Death Epidemic Near 80's H.I.V. Peak Death Level!

Drug Overdose Death Epidemic Near 80's H.I.V. Peak Death Level! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Deaths from drug overdoses have jumped in nearly every county across the United States, driven largely by an explosion in addiction to prescription painkillers and heroin.

Some of the largest concentrations of overdose deaths were in Appalachia and the Southwest, according to new county-level estimates released by the Centers for Disease Control and Prevention.

The number of these deaths reached a new peak in 2014: 47,055 people, or the equivalent of about 125 Americans every day.

The death rate from drug overdoses is climbing at a much faster pace than other causes of death, jumping to an average of 15 per 100,000 in 2014 from nine per 100,000 in 2003.

The trend is now similar to that of the human immunodeficiency virus, or H.I.V., epidemic in the late 1980s and early 1990s, said Robert Anderson, the C.D.C.’s chief of mortality statistics.

Pharma Guy's insight:

It's clear the so-called "War on Drugs" has been lost - except for municipalities collecting millions in fines and legal fees and federal funds to incarcerate people. At least one municipality - Goucester, MA - has a different approach. For more on that, read "Perfect Storm: Gloucester Police Targets #Pharma as Next Step Against 'War on Drugs'"; http://sco.lt/90L66j 

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Rahm Emanuel's War on Drugs

Rahm Emanuel's War on Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Seven years ago, the maker of OxyContin pleaded guilty to criminal charges that it had promoted the painkiller for off-label uses and played down its risk of addiction. The settlement, which cost Purdue Pharma $600 million, was supposed to stem the dramatic rise of prescription painkiller abuse that has swept the U.S. since OxyContin hit the market in 1996.


In the years since the settlement, America’s opioid problem has only gotten worse. Deaths involving prescription painkillers tripled in the first decade of the 21st century to more than 40 per day, according to the Centers for Disease Control, which called the problem an epidemic in 2011.


State and local officials have asked the Food and Drug Administration to stop opioid makers from marketing the drugs for long-term pain management, but the FDA hasn’t acted and neither have the drugs’ manufacturers. So local governments are taking pharmaceutical companies to court. Civil lawsuits filed in the past month by Chicago and California’s Santa Clara and Orange counties accuse Purdue and four other drugmakers of soft-pedaling the risks of the medications. Both suits seek to force “defendants to cease their unlawful promotion of opioids and to correct their misrepresentations” as well as pay unspecified damages.


Emanuel says he’s fed up with FDA officials and industry executives who try to shift blame for the problem. “Everybody at the top wants somebody else to be accountable,” he says. “They want to act like they bear no responsibility for what’s happened.” The aim of the lawsuits, he says, is to force that accountability. The goal isn’t to punish drugmakers, says Orange County District Attorney Tony Rackauckas. “What we’re after here is to change [their] conduct, not to break companies.”

Pharma Guy's insight:


Meanwhile, former New York City mayor Rudy Giuliani earned millions of dollars defending Purdue Pharma against charges of illegal promotion of its pain drug, OxyContin, the abuse of which DEA claims has killed hundreds of people -- mostly teenagers.

Giuliani's OxyContin (and PhRMA) Money
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