Tag: overdoses

The FDA Bends Over Backwards To Get Drug Makers To Ask Them To Make Naloxone OTC

Press reports have created the impression that the opioid overdose antidote naloxone is now available over the counter. But in fact, the drug is still classified in the US as prescription only, so states have developed workarounds to make it easier for patients to obtain it without going to a doctor for a prescription. In most states, patients can get naloxone by going up to the counter and asking the pharmacist, who is legally authorized by the state to dispense it. 

But some states prohibit third parties from obtaining a prescription for another person, so people in those states who wish to have the antidote available because they have a friend or relative who uses opioids cannot obtain it. And experience shows that many pharmacists choose to not stock naloxone or participate in any distribution program. Furthermore, the stigma now attached to opioid use has deterred many patients from going up to the pharmacy counter and explaining to a pharmacist why they need naloxone.

To get around such obstacles, Australia and Italy have designated naloxone as a truly over-the-counter drug. People can discreetly buy it off the shelf and check out at the cash register.

The Food and Drug Administration is on record since at least 2016 as believing that it is probably appropriate for naloxone to be rescheduled as OTC and has encouraged manufacturers to petition the FDA to that end. Yesterday  FDA Commissioner Gottlieb announced the FDA has even gone to the trouble of designing Drug Facts Labels (DFL) required of manufactures for their products to be sold over the counter, and has even tested these labels for “consumer comprehension” in front of focus groups. The Commissioner stated in the announcement that this represents an unprecedented effort to facilitate and speed up the reclassification of naloxone from prescription-only to OTC.

This is commendable. But as I have written herehere, and here, the Commissioner does not have to wait for manufacturers, who may lack the incentive, to request the move to OTC. Under FDA regulations, the FDA can undertake reclassification review at the request of “any interested person,” or the Commissioner himself. States may petition the FDA for reclassification. Finally, if all else fails, Congress can order the reclassification.

The FDA should no longer wait for manufacturers to ask them to make this lifesaving drug more accessible to those in need.

No Let Up On The Bad News About Overdose Deaths

The National Center for Health Statistics (NCHS) just issued Data Brief Number 329, entitled “Drug Overdose Deaths in the United States, 1999-2017.” Drug overdose deaths reached a new record high, exceeding 70,000 deaths in 2017, a 9.6 percent increase over 2016. That figure includes all drug overdoses, including those due to cocaine, methamphetamines, and benzodiazepines. The actual breakdown according to drug category will be reported in mid-December. However, estimates are opioid-related deaths will account for roughly 49,000 of the total overdose deaths. 

The big takeaways, quoting the report:

- The rate of drug overdose deaths involving synthetic opioids other than methadone, which include drugs such as fentanyl, fentanyl analogs, and tramadol, increased from 0.3 per 100,000 in 1999 to 1.0 in 2013, 1.8 in 2014, 3.1 in 2015, 6.2 in 2016, and 9.0 in 2017.The rate increased on average by 8% per year from 1999 through 2013 and by 71% per year from 2013 through 2017.

-The rate of drug overdose deaths involving heroin increased from 0.7 in 1999 to 1.0 in 2008 to 4.9 in 2016. The rate in 2017 was the same as in 2016 (4.9).

-The rate of drug overdose deaths involving natural and semisynthetic opioids, which include drugs such as oxycodone and hydrocodone, increased from 1.0 in 1999 to 4.4 in 2016. The rate in 2017 was the same as in 2016 (4.4).

-The rate of drug overdose deaths involving methadone increased from 0.3 in 1999 to 1.8 in 2006, then declined to 1.0 in 2016. The rate in 2017 was the same as in 2016 (1.0).

Despite the fact that overdose deaths from prescription opioids—and even heroin—have stabilized, the overdose rate continues to climb due to the surge in fentanyl deaths. 

This has happened despite policies in place aimed at curtailing doctors from prescribing opioids to their patients in pain. Prescription surveillance boards and government-mandated prescribing limits have pushed prescribing down dramatically. High-dose prescriptions were down 41 percent between 2010 and 2016, another 16.1 percent in 2017, and another 12 percent this year.

Policies aimed at curbing prescribing are based on the false narrative that the overdose crisis is primarily the result of greedy drug makers manipulating gullible doctors into overtreating patients in pain and hooking them on drugs. But as I have written in the past, , the overdose crisis has always been primarily the result of non-medical users accessing drugs in the dangerous black market that results from prohibition. As the supply of prescription opioids diverted to the underground gets harder to come by, the efficient black market fills the void with other, more dangerous drugs. Lately, the synthetic opioid fentanyl has emerged as the number one killer.

In a New York Times report on the matter today, Josh Katz and Margot Sanger-Katz hint that policymakers are aiming at the wrong target by stating, “Recent federal public policy responses to the opioid epidemic have focused on opioid prescriptions. But several public health researchers say that the rise of fentanyls requires different tools. Opioid prescriptions have been falling, even as the death rates from overdoses are rising.”

Prescription opioids are not the cause of the overdose death crisis. Neither is fentanyl, despite the fact that it is now the primary driver of the rising death rate. The ultimate cause of the drug overdose crisis is prohibition. US policymakers should drop the false narrative and face reality, like Portuguese health authorities did 17 years ago.

Portugal, in 2001, recognized that prohibition was driving the death rate. At the time it had the highest overdose rate in Western Europe. It decriminalized all drugs and redirected efforts towards treatment and harm reduction. Portugal saw its population of heroin addicts drop 75 percent, and now has the lowest overdose rate in Europe. It has been so successful that Norway is about to take the same route.

At a minimum, policymakers in the U.S. should turn to harm reduction. They should expand syringe exchange and supervised injection facilities, lighten the regulatory burden on health care practitioners wishing to treat addicts with medication-assisted treatments such as methadoneand buprenorphine, and reschedule the overdose antidote naloxone to a truly over-the-counter drug.

Unless this happens, we should expect more discouraging news from the NCHS in the years ahead.

 

FDA Commissioner Gottlieb’s Sunday “Tweetorial” Is Both Encouraging and Frustrating

A fair reading of Food and Drug Administration Commissioner Scott Gottlieb’s “Sunday Tweetorial” on the opioid overdose crisis leaves one simultaneously encouraged and frustrated. 

First the encouraging news. The Commissioner admits that the so-called epidemic of opioid overdoses has “evolved” from one “mostly involving [diverted] prescription drugs to one that’s increasingly fueled by illicit substances being purchased online or off the street.” Most encouraging was this passage:

Even as lawful prescribing of opioids is declining, we’re seeing large increases in deaths from accidental drug overdoses as people turn to dangerous street drugs like heroin and synthetic opioids like fentanyl. Illegal online pharmacies, drug dealers and other bad actors are increasingly using the Internet to further their illicit distribution of opioids, where their risk of detection and the likelihood of repercussions are seen by criminals as significantly reduced.

As I have written here and here, the overdose crisis has always been primarily caused by non-medical users accessing drugs in a dangerous black market fueled by drug prohibition. As government interventions have made it more expensive and difficult to obtain diverted prescription opioids for non-medical use, the black market responds efficiently by filling the void with heroin, illicit fentanyl (there is a difference) and fentanyl analogs. So policies aimed at curtailing doctors’ prescriptions of opioids to patients only serve to drive up deaths from these more dangerous substitutes, while causing patients to suffer needlessly, sometimes desperately, in pain. Gottlieb validates my argument in his “tweetorial,” providing data from the Centers for Disease Control and Prevention and the Drug Enforcement Administration.

Now for the frustrating news. Gottlieb next reminds us, “No controlled substances, including opioids, can be lawfully sold or offered to be sold online. There is no gray area here.” He provides evidence of rampant illegal internet marketing of prescription opioids, with 95 percent of internet pharmacy websites selling opioids without a prescription, often conducting transactions with cryptocurrencies, and shipping these orders “virtually anywhere in the US.” This is also the way illicit fentanyl is flooding the market.

While Politicians Cut Opioid Prescriptions, Fentanyl—With Help From the “Dark Web” and the USPS— Becomes the Number One Killer

A May 22 story in Bloomberg News describes with painstaking detail the underground pipeline through which the powerful synthetic opioid fentanyl floods the US market. According to the Drug Enforcement Administration, while the Mexican cartel plays a role by using its well-established heroin and methamphetamine distribution networks, most of the fentanyl comes in to the US from China. 

The raw materials to make the synthetic opioids are cheap and they can be manufactured rather quickly in small laboratories. The laboratories are constantly creating new variations so as to skirt restrictions the Chinese government places on existing fentanyl analogs. Online distributors throughout China sell these products, making their transactions over the “dark web,” often paid with cryptocurrency, and frequently ship the products to the US via the US Postal Service or United Parcel Service. 

Many dealers purchase and use pill presses to make counterfeit OxyContin or Vicodin pills and trick non-medical users into thinking they are buying the real thing. That’s how Prince died. He preferred to abuse Vicodin (hydrocodone). Records show he never got prescriptions from doctors. He died from ingesting counterfeit Vicodin pills he obtained on the black market that turned out to be fentanyl.

The DEA reports this is the way most fentanyl makes its way to the street. As we doctors know, most pharmaceutical-grade fentanyl made for medical use does not get diverted on to the streets. In fact, the forms usually prescribed to outpatients—skin patches, lozenges, buccal films—are not very suitable for non-medical use.

The Centers for Disease Control and Prevention reports that fentanyl was responsible for 26,000 overdose deaths in 2017. But already in 2016 fentanyl accounted for more than 20,000 of the roughly 64,000 total overdose deaths (which include cocaine, methamphetamine, and benzodiazepines). Heroin came in second with more than 15,000. In fact, for a few years now, fentanyl and heroin have accounted for the majority of overdose deaths. And a great majority of those deaths had multiple other drugs on board. In New York City in 2016, three-quarters of overdose deaths were from fentanyl and heroin, and 97 percent of overdoses had multiple other drugs on board—46 percent of the time it was cocaine.

Fentanyl overdoses in the US have been rising at a rate of 88 percent per year since 2013. Heroin overdoses have been increasing at a rate of 19 percent per year since 2014 after climbing 33 percent per year from 2010-2014. Meanwhile, overdose deaths from prescription-type opioids have been increasing at a stable rate of 3 percent per year since 2009.

The National Survey on Drug Use and Health reports non-medical use of prescription opioids peaked in 2012, and total prescription opioid use in 2014 was lower than in 2012. And the survey repeatedly reports less than 25 percent of non-medical users see a doctor in order to get a prescription. Three-quarters obtain their drugs through a friend or family member or a drug dealer.

Meanwhile, while all this is going on, policymakers in Washington and in state capitals seem intent on getting the opioid prescription rate down further. State-based prescription drug monitoring programs have succeeded in reducing the prescription of high-dose opioids by over 41 percent since 2010, the peak year of opioid prescribing. And opioid production quotas, set by the DEA, were reduced 25 percent last year and another 20 percent this year, generating acute shortages of injectables in hospitals across the nation that is harming patients.

With all the evidence that the majority of non-medical users are not patients—with all the evidence that prescription rates have come down while overdose rates keep going up—with all the evidence of fentanyl and heroin flooding the black market and causing those deaths, it is time for policymakers to disabuse themselves of the false narrative to which they’ve been stubbornly clinging. This narrative blames the overdose problem on doctors prescribing pain relievers to their patients. The overdose problem has always been primarily caused by non-medical users accessing drugs in the dangerous black market created by drug prohibition. And our current restrictive policy is only driving up the death rate by pushing these users to more dangerous drugs while making patients suffer in the process.

What’s the definition of insanity?

Is FDA Commissioner Realizing That America’s War on Opioids Has Become a War on Patients?

In a May 14 blog post, Food and Drug Commissioner Scott Gottlieb expressed concern about the effect the nation’s restrictive policy towards the manufacture and prescription of opioids is having on patients with chronic pain conditions. This is one of the first signs that someone in the administration has taken note of the unintended consequences of this misguided policy—a policy that is based upon the false narrative that the overdose crisis is primarily the result of doctors prescribing opioids to patients in pain.

In response to a wide range of public input solicited by the FDA beginning in September 2017, Commissioner Gottlieb stated:

We’ve heard the concerns expressed by these individuals about having continued access to necessary pain medication, the fear of being stigmatized as an addict, challenges in finding health care professionals willing to work with or even prescribe opioids, and sadly, for some patients, increased thoughts of or actual suicide because crushing pain was resulting in a loss of quality of life.

Pointing out that, “In some medical circumstances, opioids are the only drugs that work for some patients,” Dr. Gottlieb announced that a public meeting will be held on July 9 on “Patient-Focused Drug Development for Chronic Pain,” and invited pain patients to offer their perspectives.

Hinting at his dissatisfaction with the 2016 one-size-fits-all opioid prescription guidelines published by the Centers for Disease Control and Prevention that have greatly influenced state and federal opioid policymakers, he signaled that the FDA is considering proposing its own set of guidelines. Unlike the CDC guidelines, which are not evidence-based and were never intended to be prescriptive, Gottlieb stated:

In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren’t over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments. We will take the first steps toward developing this framework in the coming months, with the goal of providing standards that could inform the development of evidence based guidelines.

Opioid prescriptions peaked in 2010, and high-dose opioid prescriptions are down more than 41 percent since then. Yet the overdose rate continues to climb year after year, with fentanyl and heroin being the major culprits while overdoses from prescription type opioids have stabilized and have even slightly receded. The overdose problem was never really primarily caused by doctors treating patients in pain. It has always been principally due to nonmedical users accessing opioids in the illegal market. And as prescription opioids have become less accessible to them, they are migrating over to more dangerous drugs. The present policy towards the problem is making patients suffer while, at the same time, driving up the death rate. 

This is the first indication that a significant member of the Administration might be coming to that realization.

Multiple Distinguished Health Care Practitioners Speak Out Against Misguided Opioid Policy

On March 30, Sally Satel, a psychiatrist specializing in substance abuse at Yale University School of Medicine, co-authored an article with addiction medicine specialist Stefan Kertesz of the University of Alabama Birmingham School of Medicine condemning the plans of the Center for Medicare and Medicaid Services to place limits on the amount of opioids Medicare patients can receive. The agency will decide in April if it will limit the number of opioids it will cover to 90 morphine milligram equivalents (MME) per day. Any opioids beyond that amount will not be paid for by Medicare. One year earlier, Dr. Kertesz made similar condemnations in a column for The Hill. While 90 MME is considered a high dose, they point out that many patients with chronic severe pain have required such doses or higher for prolonged periods of time to control their pain. Promoting the rapid reduction of opioid doses in such people will return many to a life of anguish and desperation.

CMS’s plan to limit opioid prescriptions mimics similar limitations put into effect in more than half of the states and is not evidence-based. These restrictions are rooted in the false narrative that the opioid overdose problem is mostly the result of doctors over-prescribing opioids to patients in pain, even though it is primarily the result of non-medical opioid users accessing drugs in the illicit market. Policymakers are implementing these restrictions based upon a flawed interpretation of opioid prescribing guidelines published by the Centers for Disease Control and Prevention in 2016.

Drs. Satel and Kertesz point out that research has yet to show a distinct correlation between the overdose rate and the dosages on which patients are maintained, and that the data show a majority of overdoses involve multiple drugs. (2016 data from New York City show 97 percent involved multiple drugs, and 46 percent of the time one of them was cocaine.)

Not only are the Medicare opioid reduction proposals without scientific foundation, but they run counter to the recommendations of CMS in its 2016 guidelines. As Dr. Kertesz stated in 2017:

“In its 7th recommendation, the CDC urged that care of patients already receiving opioids be based not on the number of milligrams, but on the balance of risks and benefits for that patient. That two major agencies have chosen to defy the CDC ignores lessons we should have learned from prior episodes in American medicine, where the appeal of management by easy numbers overwhelmed patient-centered considerations.”

In an effort to dissuade the agency, Dr. Kertesz sent a letter to CMS in early March signed by 220 health professionals, including eight who had official roles in formulating the 2016 CDC guidelines. The letter called attention to the flaws in the proposal and to its great potential to cause unintentional harm. CMS will render its verdict as early as today.

Until policymakers cast off their misguided notions about the forces behind the overdose crisis, patients will suffer needlessly and overdose rates will continue to climb. 

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Politicians Cannot Stop Punishing Patients for the Unintended Consequences of Drug Prohibition

It seems no amount of evidence can make political leaders disabuse themselves of the misguided notion that the nation’s opioid overdose crisis is caused by doctors getting patients hooked on prescription opioids. A group of eight senators unveiled the CARA(Comprehensive Addiction and Recovery Act) 2.0 Act on February 27, targeting the opioid crisis. It would impose a 3-day limit on all opioid prescribing for patients in acute and outpatient postoperative pain.

But the movement to restrict prescriptions is not evidence-based, as prominent experts have pointed out. The politicians base their proposal on the 2016 opioid guidelines put out by the Centers for Disease Control and Prevention. The guidelines stated:

When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.

The guidelines pointed out that the above recommendations were based on “Type 4” evidence:

Type 4 evidence indicates that one has very little confidence in the effect estimate, and the true effect is likely to be substantially different from the estimate of the effect.

It further described Type 4 evidence as being based upon “clinical experience and observations, observational studies with important limitations, or randomized clinical trials with several major limitations.”

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