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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Pennsylvania Launches Nacro Rx Database to Enable Physicians (Foxes) to Guard Against Abuse (the Hen House)

Pennsylvania Launches Nacro Rx Database to Enable Physicians (Foxes) to Guard Against Abuse (the Hen House) | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Narcotic addicts who bounce from doctor to doctor looking for prescriptions — so-called “doctor-shoppers” — are about to face a new barrier to their fix.

Starting today, Pennsylvania law demands that physicians review the prescription histories of their first-time patients before ordering them addictive opioid painkillers and many other controlled substances. Patients suspected of abusing or diverting the drugs will undergo the checks, too, part of a growing push to tame the state’s addiction and overdose epidemic.

 

Pennsylvania is the 49th nationwide to begin such a system, which centers on a statewide database to be maintained by pharmacists who fill the prescriptions. Doctors and their assistants can access the information through an internet-based interface, widely advocated by clinician and pharmacist groups.


Still, doctors and public health officials caution that preventing excessive prescriptions for the long run may worsen a related problem in the short term, nudging some prescription addicts to switch to cheaper heroin. The widespread street narcotic was a primary contributor to the state’s record tally of 3,383 drug overdose deaths last year, up more than 23 percent from 2014.

“We’re going to identify patients we didn’t know have addiction problems,” said Scott Shapiro, the Pennsylvania Medical Society president and a cardiologist outside Philadelphia. He said doctors will try to move those people swiftly into inpatient rehabilitation.


Pharma Guy's insight:

I doubt this plan would stop unscrupulous doctors from overprescribing opioids. for more on that, read “How a One Paragraph Letter to the Editor Launched the Opioid Epidemic”; http://sco.lt/5mYWrx and "How doctors wrote the script for an epidemic"; http://newsinteractive.post-gazette.com/overdosed/ 

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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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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 10:55 AM

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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AMA Takes Aim at Pfizer et al for Hiking Prices of Opioid Overdose Treatment Just When It's Most Needed!

AMA Takes Aim at Pfizer et al for Hiking Prices of Opioid Overdose Treatment Just When It's Most Needed! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO) sent five identical letters late last week to opioid overdose antidote manufacturers Pfizer, Amphastar Pharmaceuticals, Mylan, Kaléo Pharma and Adapt Pharmaceuticals with new questions on the companies’ price hikes of the life-saving drug naloxone, which has been marketed in the US for decades.

The letters, which did not cite any official figures on price increases or make any specific demands of the manufacturers, cited two recent articles, one from Politico, noting a 17-fold increase in the price of one version of naloxone, and one from Healthline, which highlighted drug shortage issues at hospitals.

Daniel Raymond, policy director at the Harm Reduction Coalition, explained to Focus that he’s heard that a few of his coalition’s programs have run out of funds a few months into 2016 because of naloxone purchases.

Raymond explained that a number of manufacturers of the sterile injectable version of naloxone dropped out of the market, leaving Pfizer’s Hospira as the sole provider. Since then, Mylan has joined in the mix, he said, but, “You need at least three or four competing generics to lower prices.”

Pfizer told Focus in a statement: "As other manufacturers have exited the Naloxone market over the years, Hospira worked hard for more than three decades to maintain the availability of this important, medically necessary product as part of our commitment to patients and physicians. We are reviewing the letter that we received late Friday afternoon from Senators Collins and McCaskill and look forward to working with the Committee on this issue."

The price of the off-patent drug in the US, despite being first approved by FDA in 1971, has steadily increased, from $1 per dose about a decade ago to between $30 per dose and $45 per dose at CVS pharmacies in 14 states, though the formulations of the drug have changed and made it easier to administer.

But what’s different about naloxone, which still isn’t offered as an over-the-counter drug in the US, as opposed to other generic drugs that have been on the market for decades and remain cheap because of competition, is that even as different versions of naloxone become more available, the price of the drug continues to rise.

Pharma Guy's insight:

On June 15, 2017, AMA "took aim at the sudden increase in cost of naloxone, the life-saving drug used to reverse the effects of opioid overdose. Community groups, schools, first responders and local governments rely on naloxone to save lives every day but are finding it increasingly costly. The AMA will raise awareness of the troubling conduct of the three manufacturers of naloxone that enlisted assistance of physician, community groups, and elected officials to raise awareness and coverage of naloxone only to precipitously and inexplicably dramatically increase prices as soon as public policy changed to increase access. The AMA also will support legislative, regulatory, and national advocacy efforts to increase access to affordable naloxone." 

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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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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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Lower Opioid Overdose Death Rates Associated with State Medical Marijuana Laws

Bottom Line: States that implemented medical marijuana laws appear to have lower annual opioid analgesic overdoses death rates (both from prescription pain killers and illicit drugs such as heroin) than states without such laws although the reason why is not clear.


Author: Marcus A. Bachhuber, M.D., of the Philadelphia Veterans Affairs Medical Center, and colleagues.


Background: Prescriptions for opioid painkillers for chronic pain have increased in the United States and so have overdose deaths. However, less attention has been focused on how the availability of alternative nonopioid treatment, such as medical marijuana, may affect overdose rates.


How the Study Was Conducted: The authors examined the implementation of state medical marijuana laws and opioid analgesic overdose deaths in the United States between 1999 and 2010. Three states had medical marijuana laws prior to 1999, 10 states implemented laws between 1999 and 2010 and nine states had laws that went into effect after 2010, which was beyond the study period. The authors also considered New Jersey’s law effective after the study period because it took effect in the last quarter of 2010. The authors analyzed state laws and death-certificate data.


Results: States with medical marijuana laws had a 24.8 percent lower average annual opioid overdose death rate compared to states without such laws. In 2010, that translated to about 1,729 fewer deaths than expected. The years after implementation of medical marijuana laws also were associated with lower overdose death rates that generally got stronger over time: year 1 (-19.9 percent), year 2 (-25.2 percent), year 3 (-23.6 percent), year 4 (-20.2 percent), year 5 (-33.7 percent) and year 6 (-33.3 percent).


Discussion: “In summary, although we found a lower mean annual rate of opioid analgesic mortality in states with medical cannabis laws, a direct causal link cannot be established. … If the relationship between medical cannabis laws and opioid analgesic overdose mortality is substantiated in further work, enactment of laws to allow for use of medical cannabis may be advocated as part of a comprehensive package of policies to reduce the population risk of opioid analgesics.”


(JAMA Intern Med. Published online August 25, 2014.doi:10.1001/jamainternmed.2014.4005. Available pre-embargo to the media at http://media.jamanetwork.com.)

Pharma Guy's insight:


Is this good news or bad news for pharma companies that market opioid drugs? Tell me your thoughts after reading this: Legalization of Marijuana. Will It Hurt Pharma?

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