HAS THE FDA LEARNED ANYTHING FROM THE OPIOID CRISIS THEY HELPED CREATE?
Mark A. York (November 6, 2018)
Just The Opioid Facts
(Mass Tort Nexus Media) More than 175 Americans will die today of drug overdoses, which equals a 737 crashing and killing all the passengers on board every single day. But it’s not a plane crash. It is America’s opioid epidemic, one that unchecked could claim 1 million lives by 2020.
See also: Briefcases/Drugs/254/OPIOID-National-Prescription-Litigation-MDL-2804-USDC-ND-Ohio-(Eastern-Division) by Mass Tort Nexus
Who’s Minding The FDA?
A new opioid tablet that is 1,000 times more potent than morphine and 10 times stronger than fentanyl was approved by the Food and Drug Administration Friday as a fast-acting alternative to IV painkillers used in hospitals.
The painkiller Dsuvia will be restricted to limited use only in health care settings, such as hospitals, surgery centers and emergency rooms, but critics worry the opioid will fuel an already grim opioid epidemic.
Also on Friday, the Drug Enforcement Administration released a report showing that prescription drugs were responsible for the most overdose deaths of any illicit drugs since 2001.
Democratic Senator Ed Markey of Massachusetts urged the FDA to not approve Dsuvia last month, saying “an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill.”
To that, FDA Commissioner Scott Gottlieb said in a statement that “very tight restrictions” will be placed on Dsuvia. This statement flies in the face of reality as proven by assigned federal agencies to monitor and enforce rules on the already existing opiates that have flooded the US marketplace and killed hundreds of thousands of Americans.
So why should we think that anything is different with a new drug that basically comes under the same oversight umbrella as fentanyl, oxycontin and all the other prescription opiates? The DEA, FDA and anyone else assigned to monitor narcotic drug use, prescribing practices as well as marketing have failed miserably again and again.
FDA Claims Restricted Access
Dsuvia will not be available at retail pharmacies or for any home use, Gottlieb said. The medication, which comes in a single-use package, also should not be used for more than 72 hours. The medicine comes in a tablet that can dissolve under the tongue. Side effects of the potent drug include extreme tiredness, breathing problems, coma and death.
Gottlieb said military use of the drug was “carefully considered in this case” as the FDA wants to “make sure our soldiers have access to treatments that meet the unique needs of the battlefield.”
Combined with the increase in overdoses, the fact that opioids are less effective than presumed creates a substantial public health problem. We are throwing large sums of public and private money at treating opioid addiction and related issues caused by a problem that could have been completely avoided by using more effective (and less habit-forming) medications.
In the midst of a national opioid crisis, the federal agency that monitors drug ads has issued a record low number of warning letters to pharmaceutical companies caught lying about their products.
The Food and Drug Administration has sent just three notice letters to drug makers busted for false marketing their medications to unknowing consumers, the lowest ever since the FDA historic decision to ease strict rules for drug ads in 1997. “It certainly raises questions,” said Dr. David Kessler, head of the FDA from late 1990 through 1996, who’s industry credentials would add weight to the issue of why the FDA is not doing more to monitor false marketing campaigns by Big Pharma and Opioid Drug makers in particular.
The FDA’s Office of Prescription Drug Promotion monitors all ads drug companies issue to make sure patients aren’t being scammed by false assertions or misleading marketing campaigns. This now seems to be the norm, based on the hundreds of lawsuits filed against Opioid Drug Makers in the last 3 months, and recently consolidated into Opiate Prescription MDL 2804 see Opioid Crisis Briefcase-Mass Tort Nexus, where Big Pharma is being sued by states, cities and counties across the country. The primary claim in almost every suit is long-term boardroom coordinated false marketing campaigns designed to push opioid drug prescriptions at any cost.
FDA Told Not to Approve Dsuvia
Drug overdose deaths hit the highest level ever recorded in the United States last year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration. Most of that was the result of a record number of opioid-related deaths.
How Big Pharma got into opiates: In 1898, Bayer released heroin to treat coughs and other health woes. Soon, people became addicted to heroin, a narcotic and precursor to the current Opioid Crisis.
Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country. About a week ago, U.S. Health and Human Services Secretary Alex Azar said overdose deaths, while still slowly rising, were beginning to level off, citing figures from late last year and early this year.
The DEA’s National Drug Threat Assessment, which was recently released, shows that heroin, fentanyl and other opioids continue to be the highest drug threat in the nation. But federal officials are concerned that methamphetamine and cocaine are being seen at much higher levels in areas that haven’t historically been hotspots for those drugs. The DEA is also worried that people are exploiting marijuana legalization to traffic cannabis into the illicit market or to states that don’t have medicinal or recreational-use marijuana laws, according to the report.
The preliminary data also showed 49,060 people died from opioid-related overdose deaths, a rise from the reported 42,249 opioid overdose deaths in 2016.
Fatal heroin overdoses rose nationwide between 2015 and 2016, with a nearly 25 percent increase in the Northeast and more than 22 percent in the South. Most of the heroin sold in the U.S. is being trafficked from Mexico, and U.S. Customs and Border Protection officers seize the most amount of heroin along the Mexico border, near San Diego, California, the report said.
Fentanyl and other related opioids, which tend to be cheaper and much more potent than heroin, remain one of the biggest concerns for federal drug agents.
The DEA has said China is a main source of fentanyl and other synthetic opioids that have been flooding the U.S. market. China has pushed back against the characterization, and U.S. officials have stressed they work closely with their Chinese counterparts as they try to stem the flow of drugs.
Legislation that Trump signed last week will add treatment options and force the U.S. Postal Service to screen overseas packages for fentanyl.
Azar said in a speech last week that toward the end of 2017 and through the beginning of this year, the number of drug overdose deaths “has begun to plateau.” However, he was not indicating that deaths were going down, but that they appear to be rising at a slower rate than previously seen.
Pot Vs. Pills for Pain Relief
Last month, the Centers for Disease Control and Prevention released preliminary figures that appear to show a slowdown in overdose deaths from December to March. In that period, the figures show that the pace of the increase over the previous 12 months has slowed from 10 percent to 3 percent, according to the preliminary CDC figures.
Even if a slowdown is underway, no one is questioning the fact that the nation is dealing with the deadliest drug overdose epidemic in its history. While prescription opioid and heroin deaths appear to be leveling off, deaths involving fentanyl, cocaine and methamphetamines are on the rise, according to CDC data.
The DEA’s report also noted that methamphetamine is making its way into communities where the drug normally wasn’t heavily used, the report said. Chronic use of meth, a highly addictive stimulant, can cause paranoia, visual and auditory hallucinations and delusions, studies have shown.
As the government enacted laws that limited access to cold medicines containing pseudoephedrine — the ingredient used to cook meth with other household chemicals — or required the medications to be placed behind pharmacy counters, officials discovered the number of meth labs began to drop.
But the DEA has found the gap is being filled by Mexican and Latin American drug cartels that had primarily dabbled in heroin and cocaine trafficking. A saturated market on the West Coast is now driving the cartels to peddle methamphetamine into the Northeast, using the same routes they use for heroin and other drugs.
Officials also warn that because of more cocaine production in South American countries including Colombia, they expect to see larger shipments at the Mexican border.
Who Said “Pain Was The Fifth Vital Sign?”
“Pain as the fifth vital sign” became policy at VA clinics as well as VA hospitals across the U.S.
It seemed odd to equate pain with something like breathing, but doctors were advised by Purdue Pharma and other opiate makers to understand the need to “dignify” and take care of pain.
Across the country doctors seemed too willing to prescribe these opioid pills for chronic pain, patients seemed too willing to take them, and insurers seemed too willing to pay.
The Joint Commission began requiring hospitals to assess all patients for pain on a scale of 1 to 10, which some claimed caused more doctors to prescribe opioids.
Purdue gave the commission a grant to produce a pain assessment and management manual.
Officials from the commission and Purdue denied the company had anything to do with the content of the manual, co-written by Dr. June Dahl, who served on the speakers bureau for Purdue.
The manual told health care facilities the side effects of opioids had been exaggerated and that physical dependence had been wrongly confused with addiction. “There is no evidence that addiction is a significant issue when persons are given opioids for pain control,” the manual said.
Paid Endorsements In Studies
Purdue officials explained that studies on opioid addiction depended on many factors, including mental health. They cited a 2008 article by Dr. David Fishbain of the University of Miami, who analyzed 79 published studies, saying he concluded the prevalence of abuse or addiction was 3.27 percent, or 0.19 percent for those with no past addiction.
Fishbain responded that his study was misinterpreted and that addiction could be anywhere between 3.27 and 20.4 percent.
Commission officials denied its new standards encouraged doctors to prescribe more opioids, blaming drug trafficking as well as diversion and abuse by individuals.
At that time, the “evidence was broadly supported by experts across the spectrum that pain was undertreated and a serious problem leading to poor clinical outcomes,” the commission said.
The commission concluded that “millions of people in the United States suffer from pain, and failure to treat their pain is inhumane.”
The Painkiller Market
Since 1987, Purdue Pharma had been selling a timed-release drug named MS Contin, the company’s version of morphine. Seven years later, annual sales topped $88 million — the best performing painkiller Purdue officials had — but they faced problems.
Doctors knew how addictive morphine could be, and most were reluctant to prescribe MS Contin to patients suffering from chronic pain.
The even bigger problem? MS Contin’s patent would expire soon.
That meant generic drug manufacturers could make their own versions of MS Contin and eat into Purdue’s share of the painkiller market.
A generation earlier, Arthur Sackler, the brother of Purdue’s owners, had marketed Valium and other tranquilizers to women experiencing anxiety, tension or countless other symptoms. The drug broke all sales records, turning many women into addicts and Sackler into a multimillionaire.
The Sackler family planned to repeat that success with a timed-release version of OxyContin, the company’s version of oxycodone.
In internal Purdue documents obtained by the USA TODAY NETWORK, company officials gushed that OxyContin could become a hit in “the $462 million Class II opioid marketplace.”
These documents detail their strategy: They would first market OxyContin strictly for cancer pain, where doctors were familiar with oxycodone.
Then the company would pivot to the lucrative market of chronic pain, which afflicted at least 25 million Americans.
Purdue’s plan included targeting primary care physicians, surgeons, obstetricians and dentists. The company even targeted home care and hospice care nurses who would “rate the patients’ pain and make a recommendation on the type of opioid and dosage for pain control.”
The plan also included targeting patients and caregivers through Purdue’s “Partners Against Pain” program. “You are the pain authority,” the website reassured patients. “You are the expert on your own pain.”
The website declared that “there are 75 million Americans living with pain, although pain management experts say they don’t have to,” reassuring patients that doctors could control their pain “through the relatively simple means of pain medications” and that the risk of addiction to opioids “very rarely occurs when under medical supervision to relieve pain.”
To ensure that OxyContin became a hit, Purdue sponsored more than 20,000 educational programs to encourage health care providers to prescribe the new drug and sent videos to 15,000 doctors.
The company also hosted dozens of all-expenses-paid national pain management conferences, where more than 5,000 physicians, pharmacists and nurses were trained for the company’s national speakers bureau.
By 2001, Purdue was spending $200 million on marketing and promotion and had doubled its sales force to 671. Before the year ended, sales bonuses reached $40 million.
No Addiction Knowledge
Dr. Fannin, who practices in West Virginia remembers sales reps from Purdue flooding doctors’ offices in Appalachia, where poverty and pain are constant realities.
The reps gave away fishing hats, stuffed toys and music CDs titled “Get in the Swing with OxyContin.”
“Every time you turned around, you saw their faces,” Fannin said. “We had a population of doctors with very little grounding in pain, and I think Purdue took advantage of that.”
Many doctors knew about oxycodone from Percocet, which combined a small dosage of the potent opioid with 325 mg of acetaminophen.
What many of those doctors didn’t realize was that oxycodone was nearly twice as powerful as morphine, delivering a powerful high to those who use the drug.
“It’s more like heroin,” explained Dr. Andrew Kolodny, co-director of the Opioid Policy Research Collaborative at Brandeis University. “It crosses the blood-brain barrier more quickly.”
But the sales reps never mentioned that. Instead, they said OxyContin didn’t create highs like other opioids and was less likely to get people addicted.
Fannin recalled sales reps calling OxyContin “a revolution in pain care” and “much more effective” than the old drugs.
They also talked of studies, citing one that found only four of 11,882 patients — less than 1 percent — became addicted after using opioids. Portenoy and others repeatedly cited this research, with some calling it a “landmark study.”
The truth is it wasn’t even a study. It was a five-sentence letter to the editor that a doctor wrote the New England Journal of Medicine.
For the most part, Fannin believed what the sales reps were telling him, and so did other doctors in the region.
“Our knowledge about addiction,” he said, “was about zip.”
So they spread the opioid with their prescription pads, and it settled into the Appalachian mountains like the ever-present morning fog.
OxyContin, which some hailed as a “miracle drug,” became the blockbuster in 2001 that Purdue officials dreamed of, with more than 7 million prescriptions written and nearly $3 billion in revenue.
By 2015, the Sackler family, who owned Purdue, had made $14 billion, joining Forbes’ 2015 list of America’s richest families, edging out the Rockefellers.
MIDWEST AMERICA WAS TARGETED
According to sources at all levels from police and fire first responders to emergency room physicians across the country and analysts at the CDC, there’s been no slowdown in opiate based medical emergencies in the US over the last 2 years. Emergency response and ER visits for opioid overdoses went way up, with a 30 percent increase in the single year period of June of 2016 to June of 2017, according to the Centers for Disease Control and Prevention.
The increased emergency room visits also include more young children aged 3 to 14 years old, which truly reflects on the unknown number of who have access to still available opiates. These young children being able to readily find opiates at that age, shows that anyone who has an interest in getting opiates can find them. This often results in the inadvertent and tragic risks associated with younger victims who somehow are exposed and now being swept up in the opioid crisis.
Center for Disease Control’s Acting Director Dr. Anne Schuchat said overall the most dramatic increases were in the Midwest, where emergency visits went up 70 percent in all ages over 25. This is a figure that’s is comparative to prior medical emergency spikes during pandemic healthcare
Recently two important medical reports on opiate abuse have emerged indicating that the opioid crisis may be at its worst point ever.
The first study comes from the Centers for Disease Control and Prevention (CDC), a federal agency tasked with studying – and stopping – the spread of diseases, including everything from viral infections like the flu to mental health issues including drug addiction. Published in the agency’s monthly Vital Signs report, the study demonstrates that the number of opioid overdoses increased by 30% in a little more than one year from July 2016 to September 2017.
The second study comes from a group of VA medical personnel and public health researchers publishing in the Journal of the American Medical Association (JAMA), who wanted to learn how effective opioid prescription drugs were at managing long-term and chronic pain. As it turns out, opioid drugs showed less efficacy than non-opioid pain medications over a 12-month period – and in fact, over time opioids became worse for patients who had to deal with side effects that patients taking non-opioid medications did not have to deal with. Taken together, these two studies show that current opioid drug policies, procedures, prescription practices and standards of patient care clearly need to be rethought.
For Information on Opiate Litigation and other mass torts:
Kevin Thompson will speak on the Opiate NAS Addicted Infant MDL 2872 litigation as well as the status of opioid litigation and related issues at the upcoming Mass Tort Nexus “CLE Immersion Course”
November 9-12, 2018 at The Riverside Hotel in Fort Lauderdale , FL.
For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@masstortnexus.com.
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