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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Alkermes - Maker of Powerful Opioid Zohydro - Lobbies Hard for Its Expensive Treatment for Addiction!

Alkermes - Maker of Powerful Opioid Zohydro - Lobbies Hard for Its Expensive Treatment for Addiction! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The [reminder ads] have been popping up on billboards, buses and subways and in glossy magazines, with portraits of attractive men and women and a simple question in bold letters: What is Vivitrol?

 

Five years ago, Vivitrol was a treatment for opioid addiction that was struggling to find a market. Now, its sales and profile are rising fast, thanks to its manufacturers’ shrewd use of political connections, and despite scant science to prove the drug’s efficacy.

 

Last month, the health and human services secretary, Tom Price, praised it as the future of opioid addiction treatment after visiting the company’s plant in Ohio. He set off a furor among substance abuse specialists by criticizing its less expensive and more widely used and rigorously studied competitors, buprenorphine and methadone, as medications that “simply substitute” for illicit drugs.

 

It was the kind of plug that Vivitrol’s maker, Alkermes (the producer of a powerful new opioid called Zohydro), has spent years coaxing, with a deft lobbying strategy that has targeted lawmakers and law enforcement officials. The company has spent millions of dollars on contributions to officials struggling to stem the epidemic of opioid abuse. It has also provided thousands of free doses to encourage the use of Vivitrol in jails and prisons, which have by default become major detox centers.

 

The company’s strategy highlights the profit opportunities that drug companies and investors see in an opioid epidemic that killed 91 Americans every day in 2015 and is growing worse. But some of its marketing tactics, and Mr. Price’s comments, ignore widely accepted science, as nearly 700 experts in the field wrote the health secretary in a letter.

 

Not a single study has been completed comparing Vivitrol with its less expensive competitors. Some studies have shown high dropout rates, or found that many participants returned to opioid use while taking Vivitrol or after going off it. In one study that the company used to secure the Food and Drug Administration’s approval of Vivitrol for opioid addiction treatment, conducted with 250 patients in Russia, nearly half of those who got Vivitrol failed to stay abstinent over a six-month period, although they stayed abstinent and in treatment longer than those who got a placebo.

 

Further Reading:

 

Pharma Guy's insight:

Note the ad in the photo – it’s a “reminder ad,” which is forbidden by PhRMA for its members. Unfortunately, only reminder ads on TV are forbidden and only "signatories" of PhRMA's DTC Guidelines abide by the rules. Alkermes is a member of PhRMA and Richard Pops, Chairman and CEO of Alkermes, is on the board of directors of PhRMA! but Alkermes is NOT a signatory!

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Doctors Are the Primary Opium Pushers of the 21st Century: Gateway to Heroin

Doctors Are the Primary Opium Pushers of the 21st Century: Gateway to Heroin | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Heroin deaths have increased by 45 percent -- an increase blamed on the use of addictive prescription painkillers.


According to a study published in JAMA Internal Medicine,7 while most opioid drug abusers obtain the drug from a friend or relative, (23 percent pay for them; 26 percent get them for free), individuals who are at greatest risk for drug abuse are just as likely to get theirs from a doctor's prescription.


Previous drug abuse prevention programs have primarily focused on those who get their hands on opioids without a prescription. You may recall ads from previous years promoting the safe storage and disposal of prescription medication.


But such efforts have completely missed those at greatest risk for a drug overdose, i.e. those who use such drugs per doctor's orders. Twenty-seven percent of the highest-risk users get their drugs from their doctor even when they're using the drug nonmedically for 200 or more days per year... CDC Director Tom Frieden M.D., M.P.H recently echoed the study's authors when he said that:


"Many abusers of opioid pain relievers are going directly to doctors for their drugs. Health care providers need to screen for abuse risk and prescribe judiciously by checking past records in state prescription drug monitoring programs. It's time we stop the source and treat the troubled."


Another JAMA study notes that, of the drug overdose deaths occurring in Tennessee between 2003 and 2010, more were caused by prescription drugs than heroin and cocaine combined. Incredibly, between 2007 and 2011, one-third of the population of Tennessee filled at least one prescription for an opioid each year... According to the authors:


"High-risk use of prescription opioids is frequent and increasing in Tennessee and is associated with increased overdose mortality. Use of prescription drug–monitoring program data to direct risk-reduction measures to the types of patients overrepresented among overdose deaths might reduce mortality associated with opioid abuse."

Pharma Guy's insight:


FDA is also part of the problem. For more on that, read: Why the FDA Approved Zohydro


Some highlights:


More than 40 consumer organizations, health care agencies, addiction treatment providers, and community-based drug and alcohol prevention programs called on the FDA to revoke its approval of Zohydro, "an opioid so powerful that a single dose could kill a child," according to Public Citizen (seehere).

In addition, "a group of more than 40 doctors is hoping to preempt its release by urging the FDA to reconsider its decision," reports Regulatory Focus (see "Docs v. Zohydro"). "According to the letter penned by the doctors, Zohydro is five to 10 times stronger than its nearest equivalent, Vicodin, and has the potential to cause a severe rise in overdose deaths."


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Kacey Townsend's curator insight, April 6, 2016 3:55 PM

Many abusers of opioid pain relievers are going directly to doctors for their drugs. Twenty-seven percent of high-risk users get their drigs from their doctor even when they're using the drug nonmedically for 200 days or more. Heroin deaths have increased by 45 percent- an increase blamed on the use of addictive prescription painkillers.

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Anti-addiction advocates call for outster of FDA chief

Anti-addiction advocates call for outster of FDA chief | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Anti-addiction activists are calling for the Food and Drug Administration’s top official to step down, saying the agency’s policies have contributed to a national epidemic of prescription painkiller abuse.


In a letter released Wednesday, more than a dozen groups ask the Obama administration’s top health official to replace FDA Commissioner Dr. Margaret Hamburg, who has led the agency since 2009. The FDA has been under fire from public health advocates, politicians and law enforcement officials since last October, when it approved a powerful new painkiller called Zohydro against the recommendation of its own medical advisers.


The new letter is the first formal call for new leadership at the agency over the issue.


“We are especially frustrated by the FDA’s continued approval of new, dangerous, high-dose opioid analgesics that are fueling high rates of addiction and overdose deaths,” states the letter, which is addressed to Health and Human Services Secretary Sylvia Burwell, who oversees the FDA and other health agencies. The groups signing the letter include Physicians for Responsible Opioid Prescribing, a 900-member advocacy group that petitioned the FDA to drastically restrict opioid use. The FDA rejected that petition last year.


Pharma Guy's insight:


The opiate Zohydro was approved by the FDA although that decision went against the recommendation of the agency’s own advisory panel, which voted 11 to 2 against approving the drug because of its potential for abuse.

More than 40 consumer organizations, health care agencies, addiction treatment providers, and community-based drug and alcohol prevention programs called on the FDA to revoke its approval of Zohydro, "an opioid so powerful that a single dose could kill a child," according to Public Citizen.


For more on this, read 

Why the FDA Approved Zohydro

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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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FDA Fires Back At Critics of its Zohydro Policy

FDA Fires Back At Critics of its Zohydro Policy | Pharmaguy's Insights Into Drug Industry News | Scoop.it
After months of intensifying criticism over its decision to approve the Zohydro ER prescription painkiller, the FDA is trying to push back.


“The problem of opioid overdose demands well-informed policies. The actions taken by FDA may help to reverse the epidemic,” they write in JAMA. “…Policies that focus on a single drug can divert focus from broader, further-reaching interventions… The concerns over Zohydro ER should be seen in the greater context of the opioid epidemic. Singling out one drug for restrictions is not likely to be successful.”


The opinion piece, which was co-authored by Janet Woodcock, who heads the FDA Center for Drug Evaluation and Review, was published online one week after more than a dozen patient advocacy groups called for FDA commissioner Margaret Hamburg to resign. In their view, the agency has been “putting the interests of analgesic makers ahead of the public’s health.”

Pharma Guy's insight:


"The actions taken by FDA may help to reverse the epidemic..." Whaaa?!

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Governors (& Docs) Urge HHS to Rescind FDA Approval of the Zohydro Painkiller

Governors (& Docs) Urge HHS to Rescind FDA Approval of the Zohydro Painkiller | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In the latest bid to squelch availability of the Zohydro ER painkiller, a handful of governors from New England have asked the U.S. Department of Health and Human Services to rescind approval of the controversial drug.


The governors – from Massachusetts, Vermont, New Hampshire, Rhode Island and Connecticut – argue that the prescription painkiller should be yanked because of an “epidemic” of opioid addiction that is spreading through their states.


The request, which was conveyed in an Aug. 28 letter to HHS Secretary Sylvia Mathews Burwell, reflects ongoing concern that the abuse and misuse of opioid painkillers is fueling not only a spate of addiction and crime, but is also serving as a bridge to a growing heroin trade.


***************ADDENDUM***************

The opiate Zohydro was approved by the FDA although that decision went against the recommendation of the agency’s own advisory panel, which voted 11 to 2 against approving the drug because of its potential for abuse. Read:  Why the FDA Approved Zohydro

*******************************************


As noted previously, the pill is the only opioid painkiller to contain nothing but hydrocodone; unlike other opiates, Zohydro ER does not contain acetaminophen, which can cause liver damage. This feature is seen as a plus. But while the drug is designed to be released slowly over a 12-hour period, it lacks abuse-deterrent features – the pill can be crushed, chewed or mixed with alcohol to provide a kick.


The FDA has defended its decision to approve Zohydro ER by explaining that patientsneed an option for treating pain, since other opioids containing hydrocodone also contain acetaminophen. As the agency sees it, providing as many treatment options as possible is an important goal.


But the governors noted that an FDA advisory panel had actually recommended the agency should not approve Zohydro ER. And they add that the manufacturer, Zogenix, plans to seek approval next month to sell a version of the drug that contains abuse-deterrent features.


“As our federal partner, we urge you to overturn the FDA’s erroneous decision,” the governors wrote to the HHS. “The likelihood of abuse as well as the anticipated availability of an alternative [drug] are reasonable grounds for the FDA to rescind its approval. Our states do not need another high risk drug that will only contribute to the current epidemic of prescription drug abuse.”

Pharma Guy's insight:


In addition, "a group of more than 40 doctors is hoping to preempt its release by urging the FDA to reconsider its decision," reports Regulatory Focus (see "Docs v. Zohydro"). "According to the letter penned by the doctors, Zohydro is five to 10 times stronger than its nearest equivalent, Vicodin, and has the potential to cause a severe rise in overdose deaths."

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