Analysis: Meet the opioid wholesalers who became middlemen for the heroin epidemic

http://www.wcpo.com/news/opinion/analysis-cities-counties-states-target-opioid-wholesalers-over-the-heroin-epidemic

This article is part of the WCPO.com project “Heroin: How Do We Respond?”

You can view the I-Team story tonight on WCPO 9 On Your Side at 6 p.m.

As the nation’s opioid addiction grew out of control in the five years between 2007 and 2012, one Cincinnati company sold more than 4 million doses of highly addictive prescription pain pills to one county.

A county of only 200,000 people.

Omnicare, a big supplier of drugs to pharmacies, hospitals and nursing homes, is one of at least five Cincinnati-area companies now in the sights of states and counties fighting back against the opioid epidemic that is killing their residents, draining their budgets and stretching their resources to the breaking point

These companies played a key role in the epidemic, shipping millions of doses of addictive narcotics around the country, including to doctors’ offices and pain clinics that became known as “pill mills,” the lawsuits say.

Omnicare and other pharmaceutical wholesalers typically conducted business behind the scenes, supplying retail drug stores, hospitals and nursing homes with the pharmaceuticals they order for their patients and customers. But the tsunami of pain pills that washed over the country and, in particular, here in the nation’s heartland, would not have happened without their participation.

They are, essentially, drug dealers, selling prescription narcotics that are chemically akin to heroin and doing it on a massive scale. Whether they did so legally or not is the question.

A growing number of cities, counties and states claim they haven’t and are suing these drug middlemen, saying they precipitated the heroin and opioid epidemic that has cost so many lives and damaged so many others.

Many people began their journey into addiction with pain pills such as Oxycontin and Vicodin, which they often acquired from disreputable doctors or pain clinics. But when the street price of the pills became too high and states cracked down on the pill mills, many of the addicted turned to heroin, which was cheaper and even easier to get.

Five Cincinnati-area companies sued

On Tuesday, the city of Cincinnati became the latest jurisdiction to sue pain pill wholesalers when it targeted three major ones — Cardinal Health, McKesson Corp. and AmerisourceBergen. A day later, Hamilton County agreed to join that lawsuit.

In July, Clermont County declared the opioid epidemic a public nuisance and sued the same three wholesalers. Five other Southern Ohio counties, including Brown and Adams, have joined that lawsuit.

The state of Kentucky says it plans to sue distributors, and the state of Ohio is considering doing the same.

The Omnicare sales figures come from a lawsuit filed in March by the commissioners of Kanawha County, West Virginia, the home of that state’s capitol, Charleston.

It names 16 distributors, including five from the Cincinnati region: Omnicare, Kroger, Springboro-based Miami-Luken, Masters Pharmaceutical Inc. and Blue Ash-based Keysource Medical Inc.

All the companies are part of a previously obscure link in the chain that supplied doctor’s offices and consumers with pain medicine, and led — many experts agree — to addiction and heroin.

Carol Wagner’s son, Chad, died of a heroin overdose at the age of 37. His addiction started with the painkillers Oxycontin and Vicodin, which a doctor prescribed for his carpal tunnel syndrome.

“He was a wonderful kid,” said Carol, who lives in Fort Mitchell. “He went to the University of Kentucky, he played ice hockey for the university. He was handsome, he was charismatic, he was hard-working. He was all the things you would want in a child.”

By the time he overdosed and died in a Cincinnati halfway house on May 20, 2005, he had lost his marriage, his home and had filed for bankruptcy because of his addiction.

His mother says drug wholesalers and others should answer for the drug epidemic.

“We are in an opioid crisis,” she said. “People are dying. They need to be held accountable.”

But holding them accountable is not always easy.

At least two local wholesalers years ago attracted the attention of the U.S. Drug Enforcement Administration, which tried to shut them down.

One, Masters Pharmaceutical, has been under investigation by the DEA for nearly 10 years.

In 2008, the agency threatened to revoke the company’s license to sell controlled substances such as pain pills, saying it violated the law by selling the powerful narcotic hydrocodone to “rogue Internet pharmacies.”

Masters employees should have known that those orders were suspicious, the DEA said.

The company reached a settlement with the DEA, but by 2013, the feds again threatened to revoke its license. Employees were still failing to detect and report suspicious orders of oxycodone, better known by brand names Oxycontin and Percocet, it said. The company had filled orders of millions of doses of those drugs to eight “illegitimate pharmacies” in Florida and Nevada, the DEA argued.

Federal regulations require wholesalers to report to the DEA suspicious orders of narcotics. These can include orders that are unusually large or are made too often. The agency requires the wholesaler to investigate suspicious orders and refuse to fill them if they are suspect.

But “Masters employees frequently simply brushed suspicion under the rug by deleting orders or paring them down and shipping them without reporting them to DEA,” federal judge Susan Dlott ruled in a 2011 lawsuit.

Masters employees also accepted “half-baked or implausible explanations its customers supplied,” the judge wrote.

Still selling, even as DEA investigates

Masters has fought the DEA’s enforcement at every step and continued to sell opiates while its case has been under appeal. The company operates distribution centers in Fairfield and Forest Park. Last week, a federal appeals court judge in Washington, D.C. ruled against the company, clearing the way for the DEA to suspend its license.

But the company will stay in business because the DEA approved a license for a new Masters facility in Mason in December 2016, even as the previous case worked its way through appeals.

Keysource Medical is a relatively small, independent drug supplier operating out of just one facility in Blue Ash. But DEA investigators paint a portrait of a company that played an outsized role in the pain pill wave that inundated the country.

Keysource specialized in generic hydrocodone and oxycodone, which the DEA calls the most widely abused pills in the country. Although it is a relatively small supplier, Keysource became one of the top wholesalers of pain pills to Florida pharmacies, the DEA said.

In a two-year period, Keysource sold more than 59 million doses of oxycodone to customers in 40 states, the DEA said. The vast majority of that — 78 percent — was sold to pharmacies in Florida, which was known as a haven for pill mills, the DEA said.

Some of those pills made their way back to Ohio and Kentucky via what DEA officials called the “Florida Pipeline” or the “Oxycontin Express.” Drug traffickers would hire people to drive to pill mills in Florida every two weeks or so, buy oxycodone for $40 a bottle, drive it back to Ohio or Kentucky and sell it on the black market for $1,500 a bottle, according to a DEA narrative.

In 2011, the DEA raided Keysource’s Blue Ash office and seized sales records, emails and letters. It suspended the company’s license to sell narcotics “to stop KMI from adding any more fuel to the flame of what is an imminent and serious public health problem.”

Keysource “was sending tens of millions of pills of oxycodone into Florida, the national epicenter of the pill problem,” a DEA investigator said in court documents.

The company “was the number one independent distributor in the country for sales of oxycodone in 2010 and in the first three months of 2011,” the investigator said. “No other single-facility distributor distributed more oxycodone during that period.”

Like Masters Pharmaceutical, Keysource and its employees are accused of manipulating records to hide unusually large orders from pill mills.

Keysource Medical in Blue Ash Wholesaler-supplied pill mills were the drug dealers for many like Amy Parker, who got addicted and then turned to heroin after first being prescribed narcotics by a doctor.

 

More than 10 years ago, Amy saw a doctor in Hamilton for back and knee pain. After waiting hours to see him — a line of patients stretched down Route 4, she says — he prescribed her the powerful painkillers Opana and Oxycontin in an appointment that lasted just minutes. She ended up addicted, and when she could no longer get the pills, she turned to heroin.

Amy, who lives in West Chester now, survived pain pills and heroin and has been in recovery for nearly five years.

 

Amy Parker

Many more have not survived.nIn Ohio alone, at least 19,449 people died from drug overdoses between 2005 and 2015.

 

Who is ‘financially responsible’?

Now, cities, counties and states in need of money to clean up the ongoing carnage are suing these companies, accusing them of knowingly fostering the gross overprescription of painkillers. And they are seeking compensation.

“These community-based problems require community-based solutions which have been limited by budgetary constraints at the state and federal levels,” the West Virginia lawsuit says. Cincinnati wants to hold the distributors “financially responsible for … the hazards to public health and safety” they caused.

Both Cincinnati and Clermont County officials are seeking damages to compensate for the costs of medical care for overdose patients, the costs for treatment and rehab, costs for babies born addicted and increased costs of law enforcement. They’re also seeking punitive damages.

The Cincinnati-area distributors had little to say about the lawsuits or the DEA actions.

Keysource Medical’s CEO, Todd Szewc, would not comment on the lawsuit or the DEA action.

An attorney for Masters Pharmaceutical did not comment on the charges, but emailed briefs filed by three pharmaceutical trade associations that said the DEA changed its reporting requirements without enough notice.

Omnicare is now owned by pharmacy giant CVS. An official there said, “We believe the allegations have no merit.” She also emailed a general statement that said “CVS Health is committed to the highest standards of ethics and business practices, including complying with all federal and state laws governing the dispensing of controlled substance prescriptions, and is dedicated to reducing prescription drug abuse and diversion.”

Kroger would not comment or even provide information about its affiliates that supplied its pharmacies.

Miami-Luken declined to comment.

Although these lawsuits have the potential to bring milions to budget-strapped communities, it’s unlikely they will be settled anytime soon. Attorneys expect such cases to last about two years.

.This is a good example of a author writing and not researching accurate background information. This author is claiming that OMNICARE is part of the opiate epidemic, however, Omnicare only services institutional pts ( Nursing homes and the like) where if medication are not sent to the facility to conform to the prescriber’s orders… the nursing home is at risk of being cited by the state for failing to follow prescriber’s orders and PT NEGLECT.

Pts in these facilities DO NOT have access to their medication. They are provided to the pt per the prescriber’s medication orders.

Many of the pts in these facilities are in “skilled beds” which means that they are “high acuity pts” and require care similar to what is found/provided in a hospital.  They tend to be very sick and require multiple medications.

The end of my pharmacy career was working in a Omnicare pharmacy… for about 6 yrs.  I am very familiar with the LTC pharmacy operation.

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A Medicaid patient lost the care he’d received for 20 years. 3 months later, he was dead.

http://www.desmoinesregister.com/story/news/investigations/2017/08/13/medicaid-patient-lost-care-hed-received-20-years-3-months-later-he-dead/488367001/

ORANGE CITY, Ia. — Thirty-two years ago, a vehicle accident left Todd Mouw a quadriplegic, unable to feed himself and needing a ventilator to breathe.

Yet for decades he was able to live at home with the help of family, aided by medical staff who visited him daily to help provide 24-hour care.

That care abruptly ended when a for-profit company that Iowa hired last year to manage the state’s Medicaid program announced that some of the staffers who had attended to Mouw all those years weren’t qualified, and it wouldn’t pay for the cost.

As he and his wife Cyndi futilely searched for qualified help, Todd’s health dissipated. He had to leave his home for care, and on July 8 he died at age 53. 

Now, Cyndi Mouw is speaking out, blaming her husband’s death on Iowa’s decision to turn over its Medicaid program to for-profit companies she believes are unilaterally denying or revoking medical services to potentially thousands of other disabled or elderly Iowans.

“If they’re trying to do this because they need to save money? Well, find other places,” Cyndi Mouw said. “And, yeah, I’m sure he’s not the only one.”

Her criticisms have echoed those of other families who complain that the private companies now managing the state’s Medicaid program are denying care that the state once approved.

And the state’s long-term care ombudsman said she has received hundreds of complaints from Medicaid recipients who are appealing decisions of the private managers hired by the state.

A lack of care

Todd Mouw’s problems began in March.

That’s when Amerigroup, one of three companies hired in 2016 to manage Iowa’s Medicaid program, notified the family that it was terminating a longtime waiver that allowed some of Mouw’s in-home workers to assist in such tasks as tracheostomy care.

Although some of the health provider firms and their employees had for nearly two decades provided Mouw’s care and equipment, Amerigroup said they no longer considered the workers qualified.

Amerigroup instead required registered nurses to provide some of the services that had for years been provided by home-health aides.

The requirement for higher-qualified staffing left the family scrambling for months to find workers Amerigroup would approve for payment.

When Cyndi Mouw thought she had identified potentially qualified workers, she said weeks of administrative delays resulted in repeated missed care for her husband.

In the months that followed, Todd Mouw would sometimes go unsupervised because no staff had been approved to provide care for him, Cyndi Mouw said.

When she had to go to work, she would monitor her cellphone in case her husband alerted her to an emergency care issue.

Several times, she said, she found her husband nearly unresponsive because the passageway of his trachea tubes needed to be cleared of mucus buildup. 

“When I got the calls, I’d put on my hazard lights and I’d fly home,” she said, describing calls where all she could hear were the background sounds of his vent alarm system blaring warnings about her husband’s dropping oxygen levels.

“There were a couple times when he was blue when I got home. But we had no other option.”

In May, Todd Mouw developed pneumonia and was hospitalized.

Although he initially improved, he was never able to return home for lack of in-home workers.

Instead, he was sent to a facility in Sioux Falls, S.D., that specialized in respiratory ailments. He died at the facility about six weeks after he arrived.

Cyndi Mouw said her husband was happier at home. She believes he was provided better care there because his longtime workers were acutely aware of his needs.

“I do believe with all my heart this could have been prevented,” Cyndi Mouw said of Todd’s death.

Complaints, lawsuit follow Iowa’s money-saving plan 

Iowa’s government for decades had managed the state’s Medicaid program, which serves more than 568,000 poor or elderly Iowans. 

That changed last year when then-Gov. Terry Branstad decided to move the state’s Medicaid management to three private companies, saying health care would improve and the state would save tens of millions of dollars each year. The companies help decide which health procedures Medicaid will pay for.

Three companies — AmeriHealth, UnitedHealthcare and Amerigroup — began managing the program in April 2016. The three companies were paid $1,041 to $3,313 a month for each Medicaid patient they oversaw.

Since then, hundreds of Iowans have logged complaints, many saying the companies have unfairly denied access to care.

In June, six Iowans with disabilities filed a federal lawsuit against Gov. Kim Reynolds, accusing the state of depriving thousands of Iowans that are part of the $4 billion program the legal right to live safely outside of care facilities.

Iowa’s Medicaid system had for years granted hundreds of “exceptions to policy” that allowed people like Todd Mouw flexibility to hire specialized care and — in some cases — spend more money than is allowed for a standard Medicaid patient. 

But under management by the for-profit companies, those exceptions disappeared.

Medicaid recipients can challenge the companies’ decisions. And in hundreds of cases, recipients have sought help to resolve the disputes from the state’s long-term care ombudsman — an independent agency within the Iowa Department on Aging that investigates complaints. 

Todd Mouw’s death is significant because he is an example of a disabled Iowan who had to be institutionalized following a for-profit company’s decision, said Deanna Clingan-Fischer, the state’s long-term care ombudsman. Mouw had contacted her office weeks before his death.

Clingan-Fischer said her office doesn’t know the number of people it has helped who were institutionalized because of a decision by one of the private companies. It’s part of a larger issue of reported service deficiencies that her staff finds concerning.

“It’s unfortunate they couldn’t maintain his level of care,” Clingan-Fischer said of Mouw, noting her office is no longer reviewing the case because of his death.

Serious claims have also been made against the companies in other states.

Multiple health providers claim in a lawsuit filed in Los Angeles federal court that WellPoint, which is a part of Amerigroup, orchestrated a scheme to reduce reimbursement payments. Portions of the lawsuit, first filed in 2009, have been dismissed, but others are still being litigated.

Among the plaintiffs are medical groups from California, Connecticut and Georgia.

UnitedHealthcare, in turn, is accused of using illegal and deceptive practices to deny or limit treatment for patients with mental illness, according to a class-action lawsuit filed by the New York State Psychiatric Association.

A Des Moines Register investigation in 2015 found that each of the three managed-care companies operating in Iowa has been accused in other states of serious service and administrative errors, including denial of medical services to poor residents.

The Register documented hundreds of millions of dollars in fines or settlements and more than 1,500 individual sanctions in the past five years against the companies.

Companies say they’re helping people

Starting in July, the Register made multiple attempts to ask Amerigroup representatives questions about Todd Mouw’s case. 

Cyndi Mouw signed waiver forms requested by Amerigroup to allow the company to speak about her husband’s care.

But on July 31, Amerigroup said it additionally needed records showing Cyndi Mouw as the executor of her husband’s estate. Cyndi Mouw said she had no need to be appointed executor, since her husband had no assets, and she couldn’t afford the court costs.

Amerigroup spokeswoman Denise Malecki said other members would testify that they wouldn’t have been able to obtain the health services they needed if it wasn’t for her company.

“It has seemed as if distaste for the new Iowa Medicaid managed-care program is the popular opinion, but we are seeing otherwise,” Malecki said. “There are a lot of people who have been helped and willing to share their stories to let others know that help is available.”

The Register requested the names and contact information of the people Malecki referenced. She did not respond.

Earlier this month, Gov. Reynolds released a statement noting Iowa Medicaid patients’ satisfaction was ranked among the highest in the nation, according to a J.D. Power survey conducted in July.

“Medicaid modernization improves access, gives patients more choices and brings accountability to the program,” Reynolds said in her statement.

J.D. Power declined to identify who paid the company to use its survey results. Brenna Smith, a spokeswoman for Reynolds, said it wasn’t the state.

Community living vs. institutions

Department of Human Services spokeswoman Amy McCoy said she couldn’t speak to specifics about Mouw’s case, partly because of the pending class-action litigation filed against the state by the advocacy group Disability Rights Iowa.

But McCoy said “cost neutrality” plays a part in Medicaid care decisions.

The term is used to describe federal rules that say the aggregate cost of providing healthcare to a Medicaid member will not exceed the cost of an institutional placement.  

In other words: If it’s cheaper to institutionalize a person, that’s generally the care that must be provided.

“Our goal is to successfully and appropriately serve Iowans with mental health and disability needs in the least restrictive setting possible while remaining good stewards of taxpayer resources,” McCoy said.

Cyndy Miller, an attorney for Disability Rights Iowa, said McCoy’s response does not consider federal laws such as the Americans with Disabilities Act and the Olmstead mandate.

That’s a law and a court ruling that have determined that people with disabilities have a right to live in the community, rather than in institutions.

Miller said there are questions about data the state uses to calculate “average aggregate costs,” specifically whether the data is too old to properly set rates.

“Institutionalization has been increasingly disfavored by the courts, giving states a greater incentive to pursue waivers and keep individuals with disabilities in their communities,” Miller said.

Cyndi Mouw hasn’t reviewed all their bills, but she said she’s confident her husband’s care was far cheaper at home than in the long-term hospitalized setting he lived in during the last weeks of his life.

Mouw said her goal is not to file a lawsuit or make Amerigroup and the state look bad. Rather, she said, she wants her husband’s death to serve as a wake-up call about serious problems in Iowa’s privately managed Medicaid system.

She recalled her husband’s “food ministry,” in which he planned meals and directed his family to regularly cook and serve needy families in his community.

“Don’t get me wrong, his death was inevitable,” Mouw said. “But I do believe with all my heart this could have been prevented and he would have lived longer.”

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A Record Number of Americans Have Tried Marijuana, New Survey Shows

https://www.fool.com/investing/2017/08/20/a-record-number-of-americans-have-tried-marijuana.aspx

Marijuana: it was once a taboo topic, but is no longer.

According to a newly released study from national pollster Gallup, more Americans than ever have tried marijuana.

Gallup has been sporadically asking Americans if they had tried cannabis over the past 48 years. Back in 1969, just 4% of respondents claimed to have tried the drug. By 1999, just a few years after California became the first state to legalize medical cannabis for compassionate use, about a third (34%) of respondents had claimed to have tried marijuana before. However, between the mid-1980s and 2010, this figure was essentially static, give or take a few percent. According to Gallup’s July 2017 survey, 45% of Americans have now tried marijuana, an all-time high. If Gallup’s profile is consistent with that of America, then, utilizing data from the U.S. Census Bureau in 2016, more than 112 million adults have tried marijuana at least once in their lives.

Along those same lines, Gallup also asked its respondents if they were current marijuana users. In 2013, just 7% affirmed that they used marijuana on a somewhat regular basis. However, in the 2017 poll, 12%, or roughly one out of eight Americans, admitted to regularly smoking cannabis. Interestingly, this was down 1% from 2016, albeit still well within the standard margins for error in polling.

Five likely reasons why more Americans than ever are trying marijuana

So, this begets the question: Why are more people experimenting with marijuana than ever before? The answer probably lies with a confluence of factors.

For starters, we’ve witnessed a notable shift in the way the American public views marijuana over the past two decades. Gallup, which has also polled Americans on their views regarding legalization for the past 48 years, has shown that favorability toward legalization has soared recently. After just 25% of the public favored its nationwide legalization in 1995, 60% were in support of such a move in its 2016 survey, an all-time high. 

The expansion of medical cannabis and recreational weed in select U.S. states, along with the end of the war on drugs, has also likely encouraged experimentation with the drug. Since 1996, 29 states have legalized medical cannabis, including Ohio and Pennsylvania last year, which did so entirely through the legislative process (i.e., without putting the measure on a ballot for residents to vote on). Eight states have legalized recreational weed since November 2012. Expansion gives Americans a legal means to try pot or, in rarer instances, become a regular legal consumer.

Select state governments could also be behind higher experimentation rates. It’s no secret that certain states struggle to balance their budgets, thusly legal cannabis acts as a new stream of tax revenue and fees that can help close or ebb budget deficits. States like Nevada, which only recently opened their doors to recreational marijuana, are counting on tax revenue from the sale of legal weed in order to make ends meet.

We can probably also point to politicians for increasing the experimentation rate. Even though marijuana is entirely illegal at the federal level, this past November was the first presidential election cycle where marijuana was a mainstream topic for the candidates. It cemented the idea that pot was no longer a taboo topic that could be avoided by our nation’s lawmakers.

Lastly, the advancement of medical cannabis and cannabinoid-based drugs in clinical trials has probably cast a more favorable view on marijuana. GW Pharmaceuticals (NASDAQ:GWPH) is attempting to bring the very first cannabis-derived drug to market next year. The cannabidiol-based oral drug, known as Epidiolex, breezed through multiple pivotal-stage studies in two rare types of childhood-onset epilepsy, Dravet syndrome and Lennox-Gastaut syndrome. Clinical studies from GW Pharmaceuticals, along with more informal research studies from universities, have painted a picture that suggests marijuana could be helpful, not harmful, in treating certain diseases.

Despite weed’s growing popularity, the federal government has dug in its heels

However, it’s also worth pointing out that in spite of more Americans than ever having tried marijuana, any chance for change in the federal government’s scheduling of the drug still seems to be a ways off.

One issue is Attorney General Jeff Sessions, who is among the most ardent opponents of marijuana. It was uncovered in June that Sessions had sent congressional leaders a letter in May requesting that they repeal the Rohrabacher-Farr Amendment, which protects legally operating cannabis businesses in legal states. In other words, Sessions requested permission from Congress to trample states’ rights and go after medical marijuana businesses.

Another issue is that Congress has far too much on its plate to concern itself with marijuana legislation. Republicans have been working on healthcare reform for more than five months, while tax reform talks have been progressing at a snail’s pace. Of the multitude of things that President Trump wants to accomplish as president, legalizing marijuana isn’t remotely on the list as of now.

The U.S. Drug Enforcement Agency (DEA) is probably of little help, too. Last year, the DEA had an opportunity to review two petitions that requested the scheduling for marijuana be changed. The DEA declined to do so, citing a lack of clinical evidence on the benefits and risks of the drug, as well as a lack of proper usage oversight. 

There’s a Catch-22 as well. Most lawmakers, along with the DEA, want more clinical data to pore over in order to make an educated decision about weed’s scheduling. Unfortunately, its restrictive scheduling also makes running the studies that are needed very difficult. You could almost say that red tape is ensuring that marijuana remains an illegal substance.

Investing in marijuana is a highly risky venture

Even with a record number of people experimenting with pot, and legal sales expected to grow by a double-digit percentage for the next five to 10 years, investing in marijuana stocks will remain a risky venture at best.

There are a number of concerns with marijuana companies that simply aren’t going away anytime soon. For example, weed companies have little or no access to basic banking services, such as a line of credit or even a checking account. This forces marijuana companies to deal solely with cash, which is a big security risk and an inhibitor of growth.

Also, the Internal Revenue Service doesn’t look too kindly on profitable pot companies. U.S. tax code 280E disallows businesses that sell an illegal substance, like marijuana, from taking normal corporate income tax deductions. Thus, if a weed business does turn a profit, it’s likely handing over far more in taxes than a “normal” business.

The result for most marijuana stocks is steady losses with no chance of really thriving until the federal government changes its stance on pot. Unfortunately, it’s unclear when, if ever, that’s going to happen.

 

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Financial Investigator Supporting the DEA at Forfeiture Support Associates

Portland, OR 97204

http://job-openings.monster.com/Financial-Investigator-Supporting-the-DEA-Portland-OR-US-Forfeiture-Support-Associates/11/187550335

About the Job

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In her own words: a woman with constant pain is denied her meds

http://www.ktuu.com/content/news/In-her-own-words-a-woman-with-cronic-pain-is-denied-her-meds-441051633.html

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FDA’s Standards for Device Approvals Under Scrutiny

Studies often low quality — or missing entirely when it comes to post-market surveillance

https://www.medpagetoday.com/publichealthpolicy/fdageneral/67300?xid=nl_mpt_WeeklyVideos_2017-08-19&eun=g578717d0r

A study appearing in the Journal of the American Medical Association documents the occasionally poor quality of clinical studies used to expand FDA approvals for high-risk medical devices. But as F. Perry Wilson, MD, discusses in this 150-second analysis, adequate post-marketing surveillance may help to balance regulation with access to improved devices.

This week, we take a walk along the rocky path of medical device regulation with this study, appearing in the Journal of the American Medical Association.

Devices are regulated in a different way than drugs. Once approved, a drug doesn’t really get changed. Indications may be expanded, but the drug is still the drug. But devices get modified frequently – think different pacemaker leads.

The FDA does not require a clinical trial demonstrating proof of safety and efficacy for all those changes – far from it. In fact, in the vast majority of cases the FDA requires no clinical data at all for approval.

One exception to that rule is for high-risk devices, which include things like cardiac stents. Modifications of these devices need to utilize the most rigorous standard, known as the “panel track.”

But, as the JAMA paper suggests, the panel track is not really that rigorous. There have only been 78 panel-track approvals between 2006 and 2016, underscoring how rare it is for a manufacturer to use this pathway. In contrast, from 1979 through 2012 there have been 5,800 non-panel track supplements for cardiac implantable electronic devices alone.

According to the study, the data supporting the changes rarely measure up to the quality we might expect. Of 83 studies supporting these approvals, only 45% were randomized. Only 30% were blinded.

Almost a quarter didn’t specify a primary endpoint. And shockingly, only 87% reported the number of patients enrolled. Only 84% reported the mean age of enrollees. These are pretty basic stats, folks.

Obviously, we could spin this data to make it look like the FDA is asleep at the wheel — but before we grab our pitchforks, let me ask this question: Why were some studies randomized, and some not?

 

The reason is that there are civil servants at the FDA whose job it is to interface with manufacturers to decide how these studies should be conducted. They are charged with determining the “least burdensome” standard of data. That’s the law. In other words, sometimes a blinded, randomized trial is the least burdensome thing you can do to make sure the device is still safe and effective. But not always. We’d need to review each of these 78 approvals separately to determine if we, as a medical community, think the data presented was inadequate.

I’m actually OK with this system, with one caveat. Rigorous post-approval research must be conducted to ensure safety, especially as indications are expanded. And here the FDA has not done a great job. The FDA has been lax about enforcing post-marketing surveillance. According to the study authors, only 13% of post-marketing safety studies are completed between 3 and 5 years after FDA approval, and the FDA has never issued a warning letter, penalty, or fine against a manufacturer for noncompliance.

Getting these products to patients quickly may be laudable, but once they are in the wild manufacturers should not be left entirely to their own devices.

Postscript

After making this video, I heard from lead author Rita Redberg concerning some questions I had with the manuscript.

I was curious about the “denominator” for these approvals. The study looks at 78 device supplement approvals, but we are not told how many rejected applications there are. Her response: “FDA does not make available the number of applications they receive and do not approve … Anecdotally, I have heard it is about 80% approved.”

Dr. Redberg also stated that she feels the current standard for approvals is relatively lax, citing a recent cluster of deaths associated with a rapidly-approved gastric balloon. She suggests that high-risk devices should face the same standard as drugs, where two preferably randomized clinical trials with meaningful endpoints are necessary for approval. Finally, she notes that post-marketing surveillance may not be the best solution to this problem (as I had suggested), as while drugs can be quickly pulled from the market, many devices are not easily removed from patients.

F. Perry Wilson, MD, MSCE, is an assistant professor of medicine at the Yale School of Medicine. He is a MedPage Today reviewer, and in addition to his video analyses, he authors a blog, The Methods Man. You can follow @methodsmanmd on Twitter.

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Did Marijuana Kill This Young Marijuana Advocate? Um, Nope

www.thefreshtoast.com/cannabis/did-marijuana-kill-this-young-marijuana-advocate-um-nope/

The headline from TODAY.com was alarming. It was equally odious. “Did marijuana kill this young man? Doctors may never know for sure” screamed the NBC-owned website known for its clumsy muchie jokes and outdated Cheech and Chong references.

The story details the death of Michael Ziobro, a 22-year-old New Jersey marijuana advocate. The story shares that Michael’s parents found medical-grade marijuana in his room, and the medical examiner found evidence of cannabis in his blood. Kristina and her husband are convinced the highly active marijuana caused Michael’s heart to go into arrhythmia and killed him.

‘He was such an advocate,’ Kristina Ziobro told TODAY.com. ‘He thought it was wonderful. He thought it was safe. He just thought it was natural and organic and it ended up killing him.”

Ending up killing him? There is no doubt that the parents are upset and grieving over the tragic loss of their son and they are grappling to understand how it could happen.

The 1,600-word story is chock full of somber quotes and cherry-picked studies, but nowhere in the story does the reporter provide these helpful informational nuggets:

• Earlier this year, the DEA published its 2017 resource guide Drugs of Abuse. The report states: “No deaths from overdose of marijuana have been reported.” The guide goes on to warn that cannabis may cause “merriment,” “happiness,” “enhanced sensory perception,” “increased appreciation of music, art and touch,” and “heightened imagination.”
• In 1988, a DEA judge wrote that a user would have to ingest somewhere between 20,000 to 40,000 times the amount of THC contained in a single joint to approach lethal toxicity. “A smoker would theoretically have to consume nearly 1,500 pounds of marijuana within about fifteen minutes to induce a lethal response,” wrote Judge Francis Young.
• Every single day, the opioid epidemic kills 146 Americans.
• Every single day, alcohol poisoning kills 6 people every day. This does not include alcohol deaths due to accident or disease. Just alcohol poisoning.

The click-baiting headline does not match the facts in the story. Nowhere in the story is there any data that would suggest that the young man died from cannabis.

Even the medical examiner says so:

Michael Ziobro’s death certificate does not list cannabis as the cause of death and Union County Medical Examiner Dr. Junaid Shaikh said he cannot say what caused the young man’s heart to start beating so erratically that it stopped.

Victor and Kristina Ziobro are unhappy with the explanation and asked state legislators, as well as the police, to investigate.

“Although there is scarce research that indicates smoking cannabis can evoke cardiovascular complications, one is unable to attribute the ‘Cause of Death’ was due to smoking cannabis,” Shaikh wrote in a letter to New Jersey state senator Thomas Kean after an inquiry.

“In my opinion, it is highly warranted that family members consult a geneticist and possibly consider cardiovascular genetic testing for hereditary causes of cardiac arrhythmia,” Shaikh added in the letter, which the Ziobros provided to NBC News. His office did not immediately respond to NBC’s request for further comment.

In this case, the alarming headline simply does not jibe with the 1,600 words below it. Perhaps a more accurate headline would read: “Did marijuana kill this young man? Grieving parents say yes, but science says no.”

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State seeks bids for real-time access to medical marijuana facility cameras

http://www.cleveland.com/open/index.ssf/2017/08/state_seeks_bids_for_real-time.html

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FDA acknowledges benefits of CBD in public comment request

https://www.csindy.com/coloradosprings/fda-acknowledges-benefits-of-cbd-in-public-comment-request/Content?oid=6759370

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Most People Who Misuse Opioids Don’t Have a Prescription

http://time.com/4881191/mmost-people-who-misuse-opioids-dont-have-a-prescription/

In the latest National Survey on Drug Use and Health, government researchers documented the extent of the opioid epidemic in the U.S., providing details on which groups are most vulnerable to abuse and addiction, and the factors that drive misuse.

More than 51,000 people completed an hour long survey conducted in person by public health officials. Using those responses as a representative sample, the researchers calculated national rates of opioid use and abuse. Nearly 92 million people, or 40% of the adult U.S. population that isn’t institutionalized, reported using prescription opioids. Among them, nearly 5% said they misused them, which included everything from using opioids without a prescription to relying on the drugs for something other than the reason they were prescribed by the physician, or taking them in larger doses or more often than prescribed. Among people who misused opioids, nearly two million were addicted to the drugs or had some type of abuse disorder.

About 40% of these people accessed opioids free from friends or relatives. Among people who developed addiction or other abuse disorders, 14% said they bought them from drug dealers or strangers.

The researchers note that over prescribing of opioids can lead to excess medications that can then be passed on, intentionally or unintentionally, to others who might abuse them. Prescribing the powerful pain killers for less serious conditions can also lead to such diversion and abuse.

People said the main reason they turned to opioids was to relieve pain, which the researchers say suggests that the drugs aren’t effective in addressing pain, or are too addictive to be useful as pain relievers.

People who were uninsured or unemployed were more likely than people with health coverage or jobs to misuse and abuse opioids. Those who said their health was poor were also more likely to both use and abuse opioids than people who were healthy. Having other addictions, to drugs like heroin, cocaine, sedatives or tranquilizers, also put people at higher risk of abusing opioids, as did having behavioral conditions such as depression. Programs to reduce opioid addiction should consider people’s history of mental illness and behavioral disorders and include close monitoring of their response to opioids, say the researchers.

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