Wisdom from Ken McKim

Purdue Pharma has to help pay for treatment of abuse of ILLEGAL SUBSTANCES ?

Pharma company settles lawsuit in Canada preventing further action on opioid crisis

www.rumblenews.net/pharma-companies-lawsuits-opioid-crisis/

Pharmaceutical company Purdue, which produces the prescription drug OxyContin that is causing widespread overdoses in Canada and the US, are on the verge of a settlement with provincial governments which could bar any further action from being taken against them in combating the opioid crisis.

As the Globe and Mail reported on Monday:

Purdue Pharma, maker of the prescription painkiller OxyContin, has agreed to pay $20-million, including $2-million to provincial health insurers, to settle the long-standing class-action suit. An Ontario court judge approved the proposed national settlement two weeks ago.

On Tuesday the settlement was approved by Nova Scotia, one of the last provinces that had yet to accept the terms of the agreement.

The lawsuit was the result of a class action on the part of up to 1,500 Canadians who suffered from addiction. But some are opposed to the decision as an acceptance of the funds would prevent any further legal action from being brought against the company as a condition of the settlement.

The settlement says class members and provincial health insurers are barred from “initiating, asserting or prosecuting any claim, action, litigation, investigation or other proceeding in any court of law…or any other forum.”

According to the most recent numbers from the Canadian Institute for Health Information, the settlement accounts for only a fraction of the money that is spent to combat addiction. as the Globe pointed out:

The provinces’ public drug plans spent $423.3-million over a five-year period on medications used for addiction to prescription painkillers and illicit opioids.

The National Post reported on Tuesday, a few provinces have yet to accept the settlement which does not find the drug company liable for the addictions its drugs caused.

Purdue did not admit liability in the national settlement, which still must be approved by courts in Saskatchewan and Quebec before individual payments that the judge estimated to average between $13,000 and $18,000 begin to flow.

Similar lawsuits have taken place in the United States which is dealing with a similar opioid problem fueled by the same pharmaceutical drugs.

In early July the Washington Post reported that the Justice Department had reached its first settlement in a slew of lawsuits that have been brought against several companies including Purdue.

Mallinckrodt Pharmaceuticals reached a $35 million settlement Tuesday to resolve allegations that the company failed to report signs that large quantities of its highly addictive oxycodone pills were diverted to the black market in Florida, where they helped stoke the opioid epidemic.

In 2007, Purdue and its top executives were found guilty of criminal violations in the companies branding which mislead doctors and patients on OxyContin’s addictive qualities. Then president of the company Michael Friedman, and others, pleaded guilty to the charges and were fined $34.5 million. According to a New York Times report on the suit:

To resolve criminal and civil charges related to the drug’s “misbranding,” the parent of Purdue Pharma, the company that markets OxyContin, agreed to pay some $600 million in fines and other payments, one of the largest amounts ever paid by a drug company in such a case.

The most recent numbers from a Canadian government report, which only recently began to collect data on opioid deaths, found that in 2016:

there were 2,458 apparent opioid-related deaths in Canada, although this figure may change as more updated data become available.

Even with the epidemic, sales of prescription opioids have continued to increase in Canada according to data from QuintilesIMS reported on by the Globe and Mail in March of 2017:

Retail pharmacies across Canada dispensed 19 million prescriptions for opioids in 2016, up slightly from 18.9 million in 2015…Prescriptions climbed six per cent over the past five years.

Blue Cross determines ADDICTION by the number of LEGAL RXS beneficiaries filled ?

Opioid addiction quintupled since 2010 and 10 other findings in new study

http://www.mlive.com/news/index.ssf/2017/07/opioid_addiction_rate_has_quin.html

2017 NATIONAL PHARMACY TECHNICIAN REGULATION SCORECARDS

2017 NATIONAL PHARMACY TECHNICIAN REGULATION SCORECARDS

https://emilyjerryfoundation.org/

 

The map on the hyperlink page is interactive…

Pharmacists are required more and more to rely on the support of technicians. But some states have seemingly placed very little necessity that the “technicians” who is assisting the Pharmacists to have any education or proper training.  Only FIVE states got a “A” while THREE states got a “ZERO”.  The primary function/charge of the Boards of Pharmacies is to protect the public’s health and safety.  You can judge from this map what states care about making sure that the technicians assisting Pharmacists are really qualified.  All states have limits on the number of technicians one Pharmacist can oversee… some states limits are TWO technicians per Pharmacists other states the ratio is UNLIMITED.  Kentucky is one of those with UNLIMITED and they received a “D” on this scorecard.

 

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Opioid Commission: Declare a State of Emergency, Mr President

Image result for Folktale the Sky Is Falling

Opioid Commission: Declare a State of Emergency, Mr President

http://www.medscape.com/viewarticle/883627#vp_1

 

The White House commission charged with advising the Trump administration on the country’s opioid epidemic is calling on President Donald J. Trump to declare a state of emergency to quickly and aggressively address this crisis.Some 142 Americans die every day from a drug overdose, said Chris Christie, chairman of the President’s Commission on Combating Drug Addiction and the Opioid Crisis, in a press briefing.

The declaration of a national emergency is “the single-most important recommendation,” Christie said.

The commission’s interim report, addressed to President Trump, said such a declaration would “empower your cabinet to take bold steps and would force Congress to focus on funding and empowering the Executive Branch even further to deal with this loss of life.”

 The report, released July 31, had been expected earlier, but Christie said it was delayed by the need to sift through some 8000 comments that were received after the commission held its first public meeting in mid-June.

The report made a number of recommendations, including some that would mandate physician education. Others would encourage and boost medication-assisted treatment (MAT) and increase availability of the overdose reversal agent naloxone.

The commission also urged an immediate change in Medicaid policy — one that would essentially require the federal government to pay for more addiction treatment, at a time when Congress has been looking at paring back Medicaid.

The healthcare community will play an increasingly crucial role in addressing the opioid epidemic, commission member Bertha Madras, PhD, told reporters.

“We are going to need an evolution or even a revolution in how the health care system addresses substance use issues,” said Dr Madras,  professor of psychobiology at Harvard Medical School, Boston, Massachusetts.

“Revolutionary” Approach Needed

Physicians need much more training in identifying people with substance use issues and to learn how to manage those individuals, she said. The healthcare system also frequently overlooks the fact that mental health problems are what she called a “massive contributor” to substance use disorders.

“If there isn’t an integration of mental and physical health in a revolutionary new way, we aren’t going to be able to address the entirety of the problem in a systematic and coordinated fashion,” Dr Madras said.

 The report’s recommendations call for mandatory training for those who prescribe opioids, which includes understanding risk factors for substance use disorders. This, the commission says, could be accomplished by amending the Controlled Substances Act to require all Drug Enforcement Administration (DEA) registrants to take a course in “the proper treatment of pain.”
 
The report urged adoption of the American Society of Addiction Medicine’s (ASAM) suggestion that all clinicians who apply for DEA registration to prescribe controlled substances be required to demonstrate competency in safe prescribing, pain management, and substance use identification.
 
Christie said the commissioners agree with the ASAM proposal and that it should also be applied to clinicians who seek renewal of their DEA registration.
 
The American Medical Association has repeatedly said that prescriber education should be voluntary, not mandatory.

The President’s commission is also recommending that states allow naloxone dispensing via standing orders and that clinicians be required to prescribe the overdose antidote along with high-risk opioid prescriptions.

 The commission further recommends the US Department of Health and Human Services (HHS) Secretary be granted the ability to negotiate reduced pricing on naloxone so that the drug is available to all governmental agencies and law enforcement.
 In addition, it directed HHS and other federal agencies to find a way to identify individuals who have overdosed and been revived with naloxone, so that their primary care or other healthcare providers can be identified.
 

Mandatory Use of PDMPs

Christie said the Commission also believes clinicians should be required to check a state’s prescription drug monitoring database before prescribing an opioid.

 Currently, 49 states have prescription drug monitoring programs (PDMPs). But the information in those databases is of no use if doctors aren’t required to use them, Christie said.
 The commission also recognizes that databases are not as useful as they could be because currently states share information. The report urges the president to direct Veterans Affairs and HHS to lead an effort to have all state and federal PDMPs share information by July 1, 2018.
 Information should also be shared among clinicians and families, the commission said. It recommended that patient privacy laws be amended to ensure that a patient’s substance use history can be shared by clinicians with other healthcare providers and family members. 
 “Sharing this information is appropriate in light of the crisis we are suffering,” Christie said.
 One of the Commission’s top recommendations was to rapidly expand treatment capacity, by allowing states to immediately seek waivers from a regulation that prohibits Medicaid reimbursement for services provided in inpatient facilities that have more than 16 beds.
 “This is the single fastest way to increase treatment availability across the nation,” the report said.
 The report also urges the Trump administration to find a way to create a federal incentive to boost access to MAT. All FDA-approved modes of MAT should be offered at every licensed MAT facility, and the decision should be based on what’s best for the individual, “not on what is best for the provider,” the report notes.
 The commission called for the federal government to find a way to reduce reimbursement hurdles for MAT.
 The commission’s other recommendations include:
 * That President Trump direct the Department of Labor to aggressively enforce the Mental Health Parity and Addiction Equity Act. Penalties should be levied on violators.
 * That more funding and manpower be provided to Customs and Border Protection, the Federal Bureau of Investigation, and the DEA to quickly develop ways to detect fentanyl, and that legislation be supported to stop opioids from being trafficked through the United States mail.
 The five-member commission was established by executive order and signed by President Trump on March 29. The panel is due to issue a final report in October.
 That report will focus on creating addiction prevention strategies and will take a close look at patients’ “satisfaction with pain” measure, which the federal government currently uses as a means of evaluating physicians.
 
“We believe this may very well have proven to be a driver for the incredible amount of prescribing of opioids,” said Christie.
 
He noted that in 2015 enough opioids were prescribed so that every American could be medicated for three weeks. “It’s an outrage,” said Christie.

gives the Attorney General of the United States unchecked authority to outlaw any substance

Image result for graphic state of emergency Escalating The War On Drugs – The SITSA Act is Approved in Committee

www.nationalpainreport.com/escalating-the-war-on-drugs-the-sitsa-act-is-approved-in-committee-8834122.html

This month, the House Judiciary Committee quietly approved a bill that would amend the Controlled Substance Act and give the Attorney General of the United States unchecked authority to outlaw any substance that meets a broad set of new criteria. As the opioid crisis in the United States rages on, lawmakers and the Trump Administration are eager to pass new legislation they believe will combat the epidemic and reduce the number of Americans that die each year due to an opioid overdose (In 2015, the CDC estimates 33,000 deaths were attributed to opioid overdoses).

The Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 (SITSA) would create a new scheduling category under the Controlled Substances Act, known as schedule A, for substances that “resemble currently scheduled substances” and have an “actual or predicted stimulant, depressant, or hallucinogenic effect on the central nervous system similar or greater to that of currently scheduled substances.” Under this new schedule, the DEA and the Attorney General will have the authority to circumvent existing procedures required to schedule any new substance.

Under current drug laws, the DEA must provide real and objective evidence to justify the scheduling of a substance. They must consult with Health and Human Services and complete an 8-factor analysis of the substance that evaluates the potential for abuse and the risk to public safety amongst other things. The DEA has complained this is an “arduous and time-consuming process” that hamstrings their ability to crack down on newly created synthetic substances.

Critics of the bill are concerned about the broad powers that would be granted to the Attorney General to escalate the war on drugs and infringe on civil liberties.

 

Many in the kratom community believe that the passage of this legislation would eventually result in the scheduling of kratom, an unregulated plant from Southeast Asia that is considered by many to be one of the best tools known to ease opiate withdrawal symptoms. The DEA attempted to make kratom a schedule 1 substance in September of last year only to withdraw their plans after huge public backlash of the decision. The independent 8 factor analysis that the DEA had to request from Health and Human Services concluded that kratom should not be scheduled. If the SITSA Act is signed into law, Attorney Jeff Sessions would have the power to outlaw substances like kratom without consulting with Health and Human Services and without performing the due diligence that is required of the DEA today, effectively expanding the power of the federal government and reducing its accountability to science and the public’s wishes.

About Author

Andrew is a libertarian and the owner of The Kratom Connection.

Sources

https://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM180870.pdf

https://judiciary.house.gov/wp-content/uploads/2017/06/DEA-Ashley-Synthetics-Testimony-HJC-Crime-Subcommittee-27June2017.pdf

http://reason.com/blog/2017/07/13/house-advances-bill-that-would-broaden-t

https://www.washingtonpost.com/news/wonk/wp/2017/06/16/congress-is-considering-a-bill-that-would-expand-jeff-sessions-power-to-escalate-the-war-on-drugs/?utm_term=.d0f89255c545

Missouri’s PDMPs, doesn’t make information available to doctors and other prescribers

There’s Something Strange About Missouri’s New Opioid Law

www.motherjones.com/politics/2017/07/theres-something-strange-about-missouris-new-opioid-law/

It’s the only state where doctors can’t see which patients are “shopping around” for opioid prescriptions.

Calling opioid addiction a “modern plague,” Missouri Governor Eric Greitens signed an executive order on Monday establishing a statewide prescription drug monitoring program, ending Missouri’s holdout as the only state without such a program. 

But Missouri’s latest legislation is very different from other PDMPs, because it doesn’t make information available to doctors and other prescribers. In every other state, the programs provide databases that allow healthcare practitioners to make sure that patients aren’t “doctor-shopping,” or getting opioid prescriptions from multiple providers. 

The databases have a mixed reputation, in part because their use is limited: One study found that only about half of primary care doctors use the programs; another found that that only a third of prescribers are registered in the systems. Critics also say that the databases alone won’t solve the problem, particularly as drug users often transition from prescription pills to illicit drugs like heroin and fentanyl. Still, the Centers for Disease Control and Prevention calls PDMPs “among the most promising state-level interventions to improve painkiller prescribing” and advocates for states to adopt mandatory prescriber participation.

Missouri has long been the single state without such a program, despite repeated attempts to pass legislation authorizing a PDMP. That’s because of a small but vocal group of state legislators, led by State Senator Rob Schaaf, who argue that making such databases available to prescribers violates patient privacy. (Schaaf also once said of drug users, “If they overdose and kill themselves, it just removes them from the gene pool,” after filibustering a 2012 version of the bill.) In the meantime, counties covering more than half the state’s population have implemented their own monitoring programs.  

After efforts to implement a monitoring program repeatedly died in the legislature, Greitens took another tack. The executive order authorizes the state to contract with private pharmacy benefit management organizations, which amass and analyze data from insurers on which doctors are prescribing what medications. The organizations will provide data on the healthcare practitioners who stand out for over-prescribing opioids to the state’s Department of Health and Senior Services (DHSS), which will in turn refer cases to law enforcement and state licensing boards. The state has already entered a $250,000 contract with Express Scripts, a benefits manager, says state DHSS director Dr. Randall Williams. Talks with other such managers, like CVS and UnitedHealth, are in the works, he added.

“When we identify those doctors through the data analytics, we can either turn them over to law enforcement if we think it’s egregious—they’re selling or prescribing drugs for profit,” said Williams. “Or we can turn them over to the Missouri healing arts board for remediation or suspension or revocation.”

The announcement immediately drew criticism from public health advocates who contend that a PDMP will not succeed without doctors on board and addiction treatment targeted at those patients abusing prescription drugs. 

“While I certainly welcome the Governor’s attention to this crisis, I have serious questions about how meaningful this action will be if doctors writing prescriptions—and pharmacists filling those prescriptions—don’t have access to this database,” said Sen. Claire McCaskill (D-Mo.) in a statement. “The welcome mat is still out for drug dealers to shop for prescriptions in our state.”

“A PDMP that providers can’t access is much less likely to be effective because you lose all the eyes and ears on the front line (e.g., doctors) and instead just have your central team looking for anomalies in a database,” wrote Keith Humphreys, a Stanford University psychiatry professor who advised the Obama administration on drug policy, in an email.

The contract with Express Scripts—and Greitens’ announcement of the executive order at the Express Scripts office—also raised some eyebrows, as the company supported Greitens’ inauguration festivities. Asked if the decision to contract with Express Scripts was influenced by the company’s financial support, Williams said, “Absolutely not.” After so many failed attempts to pass PDMP legislation, he said, the governor was looking for an alternative way to track prescription data. 

Pelosi: Healthcare is a right, not a privilege – who are you going to believe ?

https://youtu.be/VmbbvlrnXsQ?t=14m

Pelosi is minority leader of the House.. so does her statement reflect all the Democrats in the House or the whole Democratic party ?  Even with Obamacare, we have abt 10% of the population  ( 30 million) without insurance and we still spend 3.8 TRILLION on healthcare. 

Does she really mean that everyone has the right to have access to healthcare ?  But wait a minute, the DEA has stated that anyone paying CASH for healthcare is a RED FLAG ?

Our previous Surgeon General stated that addiction(s) is a mental health disease and not a moral failing http://www.huffingtonpost.com/entry/vivek-murthy-report-on-drugs-and-alcohol_us_582dce19e4b099512f812e9c

But wait a minute,  the DEA/judicial system treats opiate addiction as a CRIME… are substance abusers/addicts also have the right to have access to medical care for their mental health issues ?

Should those in the chronic pain community contact their members of Congress to ask what their position is on a person’s right to have access to medical care ?

Many politicians at both the State and Federal level are trying to limit the number of days of opiate therapy for acute pain and many/most are allowing chronic pain pts to remain on their long term opiate therapy… BUT.. if there is a limit on treating acute pain to 3-5-7 days and maybe one additional prescription for an additional 3-5-7 days.. does this mean that there is no mechanism in place for newly diagnosed chronic pain pts to receive long term opiate therapy ?  Maybe legislatures intent is to just “legislate” chronic pain away ?

BUT… Dr. Steven Severyn, director of the Pain Services and Pain Medicine Fellowship at Ohio State University Wexner Medical Center. Believes that new standard involves helping a patient improve function, not necessarily eliminating pain.. https://www.pharmaciststeve.com/?p=21495

But wait a minute… pain is a sign that something is wrong and pain usually LIMITS FUNCTION…  what is going to happen if pts are forced to push thru the pain and keeping “functioning” and causes more damage and increases pain ?

If Congress comes down on the side that everyone is entitled to ACCESS TO MEDICAL CARE… where will this leave the DEA.. going back to their original charge — chasing drug cartels that are flooding our streets with illegal opiates ?

 

But a new standard involves helping a patient improve function, not necessarily eliminating pain

Doctors prescribe fewer opioid pain killers, but experts say it’s not enough

http://www.dispatch.com/news/20170729/doctors-prescribe-fewer-opioid-pain-killers-but-experts-say-its-not-enough

The amount of opioid pain killers prescribed in Franklin County dropped by 41 percent from 2010 to 2015, but doctors still were prescribing the equivalent of a 14-day supply of the drugs for every person in the county, according to federal data.

Across Ohio, prescriptions for opioids decreased by at least 10 percent in all but 13 of 88 counties. In nine counties, the rate remained relatively stable. In four others — Hocking, Morrow, Ottawa and Van Wert — prescriptions for opioids increased by at least 10 percent, according to the Centers for Disease Control and Prevention (CDC).

Ohio Attorney General Mike DeWine said the numbers are consistent with what he sees when he travels the state.

“We have started to turn this around, but it’s tough to change the culture, and the culture in this case I’m talking about is the culture of prescribing,” he said. “We’re moving in the right direction, but we still have a ways to go.”

Across the country, the amount of opioids prescribed dropped by 18 percent. Prescriptions hit a high of what would be the equivalent to 782 milligrams of morphine per person in 2010, falling to 640 by 2015. That’s still three times higher than it was in 1999, said Dr. Anne Schuchat, principal deputy director of the CDC.

While nearly half of all U.S. counties saw a significant decrease in prescriptions from 2010 to 2015, nearly 23 percent saw an increase of at least 10 percent, according to the numbers, based on raw prescription data obtained from QuintilesIMS, a pharmaceutical analytics company.

A crackdown on the unnecessary prescription of drugs has gone on for years as law enforcement officers and state legislatures seek to curb the deadliest drug overdose epidemic in U.S. history. Users of the drugs often become addicted to the prescription pills and then move on to opioid-based street drugs, DeWine said. Three-fourths of people addicted to heroin or the far more powerful fentanyl and carfentanil started with pain medications, he added.

Doctors have become increasingly aware of the opioid problem with the knowledge that 15 to 18 percent of people are susceptible to developing a chemical dependency, said Dr. Steven Severyn, director of the Pain Services and Pain Medicine Fellowship at Ohio State University Wexner Medical Center.

As such, they have come to think not only about clinical risks when prescribing the drugs but also about risks to the community and society at large.

“Prescription narcotic medication really is the dominant form of narcotic use, at least early in drug addiction,” Severyn said. “Physicians are responding to that understanding by being certain that the use of medications for the treatment of pain is appropriate in dosing and frequency and, especially, escalation.”

In Ohio, Jackson County topped the 2015 list, with doctors prescribing 1,582 morphine milligram equivalents per person, representing a 33-day supply of the drug for each resident. Others at the top were Jefferson, Washington, Pike and Ross counties.

Vinton County (pop 13,000) saw a 98 percent decrease from 2010 to 2015, dropping to 6 morphine milligram equivalents per person, the lowest in Ohio. Also at the bottom were Holmes, Noble, Paulding and Mercer counties.

In central Ohio, decreases were seen in Delaware (30 percent), Fairfield (28 percent), Licking (19 percent), Pickaway (24 percent) and Union (15 percent) counties. Madison County remained relatively stable, with an increase of just 2 percent. Still, the counties each prescribed the equivalent of at least a 10-day supply of the drugs for every person in those counties in 2015.

Severyn noted that pain medications are still being prescribed because they are the only option for some people who are suffering.

“The other side of the argument, and the difficulty with pain medication, is that often it is the only tool that we really have for the treatment of painful conditions,” he said. “They’re very necessary.”

But a new standard involves helping a patient improve function, not necessarily eliminating pain. Severyn said his program prescribes as few opioids as possible, using other pain management techniques, including surgeries, psychological support, physical therapy, injections, nerve ablation and device implantation.

Physicians have taken a lead and become accountable in addressing the opioid problem, but more needs to be done, especially when it comes to the amount of attention and resources focused on treating people who are addicted, said Reginald Fields, Ohio State Medical Association spokesman.

He said the association assists doctors by offering Smart Rx, an online training program that helps health-care providers stay up to date on rules and regulations regarding opioids. It also gives them best practices for treating pain and offers tips on how to educate patients about the opioid problem.

Also addressing the problem is the Ohio Board of Pharmacy, which has developed prescription guidelines targeted to emergency departments and to physicians who handle chronic or acute pain, said spokesman Cameron McNamee. The board also offers education on best practices, encouraging doctors to look at alternatives before prescribing drugs.

McNamee said the board also focuses on regulations. He pointed to 2014 Ohio legislation that requires doctors to use a prescription-drug monitoring program, which allows them to track whether a patient has received prescriptions from other health-care providers. A proposal going before the legislature’s Joint Committee on Agency Rule Review this week would limit the amount of opioids that can be prescribed for acute pain, he said.

“A vast majority of people that develop addiction and move on to heroin or fentanyl use start with prescription opioids,” McNamee said. “As we make progress in reducing the amount of legal opioids prescribed, we will start seeing an impact in the amount of people dying of heroin and fentanyl overdoses.”

1,582 morphine milligram equivalents per person, representing a 33-day supply of the drug for each resident.

This calculates to 48 mg/day morphine.. and that is what some BUREAUCRATS considers a typical appropriate number of mg of Morphine to treat chronic pain pts.  Giving a pt a Morphine ER 15 mg every 8 hours – MIGHT – help the pt deal with mild-moderate pain.

It would appear that those chronic pain pts suffering from mod-severe pain would have to deal with a new standard involves helping a patient improve function, not necessarily eliminating pain..

Trump’s FDA Chief Takes Wide Aim at Opioid Addiction Crisis

Trump’s FDA Chief Takes Wide Aim at Opioid Addiction Crisis

https://www.bloomberg.com/news/articles/2017-07-24/trump-s-fda-chief-takes-wide-aim-at-opioid-addiction-crisis

The Food and Drug Administration, as part of a sweeping overhaul in how it regulates opioid painkillers, plans to look to some unusual allies to limit the flood of the addictive pills — health insurers and companies that manage prescription drug benefits.

Food and Drug Administration Commissioner Scott Gottlieb plans to meet in September with the benefit payers and insurance administrators, groups the FDA hasn’t typically worked with in its role as a drug regulator. The plan, Gottlieb said, is to stem the tide of addiction to the pills by limiting the number of people exposed to them in the first place.

Most people who become addicted to opioids are medically addicted,” Gottlieb said in a wide-ranging interview with Bloomberg in New York. “The way to reduce the rate of new addiction is to reduce the rate of exposure, and the way to reduce the rate of exposure is to make sure people are receiving prescriptions when it’s only medically appropriate.”

Gottlieb, who was picked by President Donald Trump earlier this year to lead the agency, said he views it as part of his mandate to tackle the opioid crisis, as well as other issues such as drug costs. The sessions with insurers and pharmacy managers will be his first official meetings with health-care companies, he said. The agency doesn’t have regulatory authority over insurance companies, which are largely overseen by state regulators or other departments within the Health and Human Services Department.

Millions of Pills

More than 240 million opioid prescriptions were dispensed in the U.S. in 2014, according to the Department of Health and Human Services. Deaths from opioid pain pill overdoses in 2015 totaled almost 23,000 in the U.S., double the number a decade ago, according to the National Institute on Drug Abuse.

Gottlieb said he wants to examine whether insurers and pharmacy benefit managers, or PBMs, can reduce the number of pills dispensed. That could involve changing drug labels or requiring doctor education for longer prescriptions.

“There shouldn’t be 30-day prescriptions for a tooth extraction, or 30-day prescriptions for a hernia repair,” Gottlieb said.

Gottlieb, 45, served in several senior positions at the FDA during the George W. Bush administration. He’s also worked as an adviser to investment firms and as a fellow at the conservative-leaning American Enterprise Institute, a Washington think tank.

“I’m looking at different models that could potentially be less burdensome but be more effective at achieving the goal of making sure that prescribing conforms more closely with clinical guidelines,” Gottlieb said. “They’re not in there right now. There’s no information in the drug label about what the appropriate dispensing should be.”

Opioid Mandate

Gottlieb said that he’s altered the FDA’s focus on certain issues since he was confirmed as commissioner in May, but the agency’s opioids policy has been the biggest change in focus.

“Coming out of the confirmation process, I had a mandate to try to steer the agency in a little bit of a different philosophical direction,” he said. “I talked to 65 senators who all wanted to see the agency act differently.”

In a first, the FDA in June asked Endo International Plc to pull its opioid Opana ER from the market. Endo has since agreed to stop sales of the painkiller that became a favorite of people abusing such drugs and led to a serious outbreak of HIV and hepatitis C linked to shared needles used to inject crushed versions of the drug.

The move marked a shift in FDA policy to consider how opioids are used not just by appropriate patients but also by people addicted to the pills.

“We’re constantly looking retrospectively to what’s on the market and making sure that it still makes sense relative to today’s marketplace and what’s available,” he said.

Gottlieb said the agency will keep looking at how drugs that are already on the market are used, in both medical settings and also illicit ones.

“It’s like I said on the drug pricing thing, there’s no silver bullet,” he said. “There’s not going to be one thing that we’re going to do. We’re going to be doing a long list of things.”

https://en.wikipedia.org/wiki/Scott_Gottlieb

If you read Dr Gottlieb work experiences… it would appear that once he completed his internal medicine residency.. he did little/no further “practicing medicine”.  Since the FDA is going in the direction of overseeing/influencing the utilization/treatment of subjective diseases ( pain, anxiety, depression, ADD/ADHD, mental health) having someone “at the helm” of the agency… that has little hands-on experience and must depend on their “book smarts” which can be biased by the author of the academic books and/or the biases of professors/instructors… which could have been developed in the “vacuum” of little/no hands-on clinical experience.

Just look at the numbers in this particular article… 240 million opiate prescriptions and 100+ million chronic pain pts would suggest that each chronic pain pts.. could now be getting TWO PRESCRIPTIONS PER YEAR ???

240 million opiate prescriptions and a total of 4.5 billion total prescriptions/yr… suggests that abt 5% of all prescriptions are for OPIATES ?

Dr Gottlieb  in the above wikipedia link … The nominee testified before Committee on Health, Education, Labor and Pensions (HELP).[24] There, Gottlieb equated the spread of opioid addiction with the previous epidemics of Ebola and Zika virus.  So apparently Dr Gottlieb believes that addiction/substance abuse should be considered the same as a EPIDEMIC from a  CONTAGIOUS DISEASE(s) ?

Apparently Dr Gottlieb has not made himself familiar with the statement from our previous Surgeon General that addiction(s) is a mental health disease and not a moral failing http://www.huffingtonpost.com/entry/vivek-murthy-report-on-drugs-and-alcohol_us_582dce19e4b099512f812e9c    It would be nice for the head of the FDA to be “up to date” on current beliefs on the real cause of addiction