Archive for the ‘Drugs’ Category

The Wizard Behind The Curtain – Addendum To Drive Home The Point

Thursday, February 14th, 2019

Among other things, yesterday’s post made a point about the way the PBM system (if you can call it that) makes it difficult for uninsured Type 1 diabetics to buy insulin, because of price. To beat that horse even deader, here is an excerpt from a Kaiser Health News article, in partnership with NPR, published yesterday entitled, Insulin At A Fraction Of US Cost:

Almost one year to the day after her daughter’s diagnosis, Lija Greenseid and her family were visiting Quebec City, Canada, in July 2014. Her daughter’s blood sugar started spiking and Greenseid feared her insulin might have gone bad, so she went to a pharmacy. With no prescription and fearing that her daughter’s life was on the line, Greenseid was prepared to pay a fortune.

Instead the box of insulin pens that normally costs $700 in the U.S. was only around $65 or so.

“At that point I started tearing up. I could not believe how inexpensive it was and how easy it was,” Greenseid said.

“I said to [the pharmacist], ‘Do you have any idea what it’s like to get insulin in the United States? It’s just so much more expensive.’ And he turned to me and said, ‘Why would we want to make it difficult? You need insulin to live.’”

The more Greenseid traveled with her family, the more they realized how inexpensive insulin was everywhere except in the United States. In Nuremberg, Germany, she could get that $700 box of insulin pens for $73. The same box was $57 in Tel Aviv, Israel, $51 in Greece, $61 in Rome and $40 in Taiwan.

“We get so accustomed in the United States to thinking that health care has to be difficult and so expensive that people don’t even consider the fact that it could be so much easier and less expensive in other places,” Greenseid said. “In fact, that is the case in most countries.”

Take a moment out of your busy day and think about that. Please.

And answer this question: Do you  believe America’s 1.3 million Type 1 diabetics  who require insulin every day ─ just to stay alive ─ should be forced to pay hundreds, even thousands, of dollars a month for that medicine? Or are they not worthy enough to be treated like their fellow diabetics the world over?

The Wizard Behind The Curtain – Part 2

Wednesday, February 13th, 2019

Let me tell you a story.

The year is 2015, and a workers’ compensation consultant is sitting in a highly respected insurer’s plush conference room. The consultant is meeting with the insurer’s Senior Vice President of Claims to negotiate price for an innovative specialty medicine program. What kind of program? Doesn’t matter.

The consultant has come armed with pro formas showing all costs of the program. Down to the penny. The problem is the insurer and the program are miles apart on what the insurer will pay the program’s doctors for each patient encounter. The Senior Vice President says, “Look, this isn’t exactly in our fee schedule, but the closest we can come to what is in the fee schedule is to pay your folks $85 per visit.” Hearing this, the consultant once again begins to explain why the fee needs to be $150 per visit.

This goes on for another half hour. The Senior VP finally says, “Well, maybe we could go to $91 per visit, but it’s the best we can do. Take it or leave it.” The consultant offers $140, but won’t go lower, because to do so would torpedo the program, which has demonstrated far more success, accompanied by significant cost savings, than others of its kind.

And then, it happens. The Senior Vice President in that plush conference room of this highly respected insurer says, “Hang on a minute. I’ve got it. You’re a specialty program, so we have a little latitude there. Charge us $300. We’ll pay you $150, and save our insureds $150 in the process.”

And that was how it was done. And it’s perfectly legal.

I tell that story by way of analogy.

Now let’s dream a bit. Imagine for a moment you are a pharmaceutical company CEO. You produce drugs that help sick people be healthy. Trouble is, the great big US healthcare system in which you operate makes Rube Goldberg seem like Thomas Edison. And in the center of your part of it sit pharmacy benefit managers, PBMs.

As we saw in Part One, the PBM industry has evolved in a rather chaotic way since Pharmaceutical Card System, Inc., invented the plastic benefit card in 1968. Over the intervening years, pharmacies and PBMs have developed into sometimes incestuous relationships. Today, three PBMs, Express Scripts, CVS Caremark and Optum RX, control 78% of the market. They wield tremendous power in drug pricing in a system designed to be opaque.

Essentially, the PBM’s job is to negotiate with pharmacies and drug companies, like yours, on behalf of their insurer and health plan clients. They create formularies, negotiate prices down (you give them a big discount in return for your drug being listed in their formulary), return some of the savings, called rebates,  to the clients (nobody really knows how much), and keep some for themselves. Seems simple, right? Well, it’s not. It’s infinitely more complicated and complex. And because only a very few actually understand PBMs, they remind me of the shenanigans in The Wizard Of Oz. However, it is that way only because we have allowed it to happen over the last four decades.

But back to you, Here’s your issue as a drug company CEO: You know, regardless of what price you set for your super-duper drug, you’re going to have to give a lot of it back as a discount to the PBM so it can give rebates to its clients. What’s a busy CEO to do?

Well, one answer is to set the price, the list price, so high that you’ll be able to provide a generous discount and still make what your finance folks say you must have for a profit. Just like in my analogy from above.

In a weird sort of way, this works most of the time for patients, but only if they have health insurance. What happens if they don’t? This is where things get sticky. Uninsured people get stuck paying the full list price, the one you inflated in order to provide the discount that allows you to make a profit and PBMs to (kind of) save money for their customers. This has been especially difficult for some uninsured Type 1 diabetics, who, as we have written previously (here and here), have had great difficulty paying for the insulin they need to take every day ─  just to stay alive.

Many employers have had enough of this. According to the National Business Group on Health, 75% of surveyed employers believe the rebate system does not serve to lower prices for employees, and 91% believe an alternative, more simple approach is required. Then there is CMS’s Alex Azar, of Ely Lilly fame, who wants you to price your drugs like Europeans do, which is a water fall lower than prices in the US. And let us not forget the current occupant of 1600 Pennsylvania Avenue, who, as yet unable to fulfill a campaign promise about a wall, has an outside chance of fulfilling one about drug prices.

Neither the healthcare industry, nor the US Chamber of Commerce like any of this. I imagine it might also be a bit awkward for quite a few US legislators who have been significant beneficiaries of the healthcare industry’s largesse, largess of the campaign contribution variety.

Regardless, I’m an optimist, and I keep hoping that in some way the wizard behind the healthcare curtain will go ‘poof,’ and be gone. Silly me.

 

 

What Price Life? Part Two

Wednesday, December 12th, 2018

Part Two

“Insulin is my gift to mankind” – Frederick Banting

In Part One, we noted the critical need for daily insulin injections to keep Type 1 Diabetics (T1Ds) alive. We described how Frederick Banting’s team of himself, Charles Best and James Collip recovered and purified insulin from the fetal pancreases of cows and pigs in 1922, how they successfully tested it on humans, how Banting won the Nobel Prize the following year for his discovery, how the team sold the patent for the discovery to the University of Toronto for $3.00 and how they and the University agreed to license the manufacturing rights to pharmaceutical companies royalty-free, because, in Banting’s words, “Insulin is my gift to mankind.” The team and the university wanted to incentivise drug companies to improve on the Banting team’s discovery, so the University and Banting agreed to allow the companies to improve Banting’s formulation if they could and patent any new discoveries that arose. Their hope was that drug companies would share their vision of making it possible for T1Ds to live high-quality lives and to keep insulin prices low to help them do it.

Immediately after the sale of the patent to the University of Toronto, the University licensed the manufacturing rights for insulin to Eli Lilly and Company, located in Indianapolis, Indianna, and Nordisk Insulin laboratorium in Copenhagen. Meanwhile, a few kilometers away in Copenhagen, Novo Terapeutisk Laboratorium succeeded in producing a stable liquid insulin product which it called Insulin Novo. Decades later, in 1989, these two companies would merge to become Novo Nordisk.

In the beginning, the pharmaceutical companies had the best of intentions. After all, they were manufacturing and marketing the world’s first “life-saving” drug.

Over time, the “best intentions” became the quarterly bottom line and shareholder value. The emphasis was now on next generation patents, which would stifle competition and prevent the emergence of insulin generic drugs. To this day, there isn’t one.

It is not an exaggeration to say insulin made Eli Lilly and Company and Novo Nordisk two of the top pharmaceutical companies in the world. It also hasn’t hurt the bottom line of Sanofi, the company that rounds out the insulin producing triumvirate and is the world’s fifth largest pharma by sales.

In the last 20 years, these insulin producing companies have become swept up in the craziness of U.S. health care, where prices are on a rocket ride to the moon. During that time, the list price of insulin has increased more than 700%. Of course, T1Ds who have employer sponsored health insurance don’t pay list price. The price they pay, which is much lower, is  negotiated by their insurance company or Pharmacy Benefit Manager. This also applies to T1Ds who have secured insurance either through the expansion of the Affordable Care Act or some other means. They find their insulin relatively affordable, unless they have a prescription deductible which forces them to pay the full amount for insulin until they reach the deductible total. Finally, diabetics on Part D must pay 45% of list price when they fall into the infamous “donut hole.”

But children without insurance are in a very bad place, and there are a lot of them – 3.9 million in 2017 under the age of 19 (300 thousand more than 2016).

This situation is worse, twice as worse, in states that have not expanded Medicaid through the Affordable Care Act.

Kids with Type 1 Diabetes make up about .05%, of the uninsured group. That’s 195,000 children. And then there are the young, T1D adults who can no longer be on their parents insurance plan, because they are over the age of 26. Recently, we have learned of  T1Ds who have been forced to ration their insulin. This has resulted in tragic deaths. Parents and guardians have begun to protest at pharmaceutical company gates, some carrying the ashes of their dead children. Think about that.

So, here’s a question: Should anyone in the United States who requires a daily drug just to stay alive be forced to come up with the money to pay for it? Or, should that be a government-sponsored, health care right, as in the Declaration Of Independence’s “self-evident…unalienable right…to life.”

While you ponder that, I’ll leave you with this. Banting, Best and Collip would be tremendously gratified that their “gift to mankind” has enabled millions upon millions of Type 1 diabetics to lead productive, fulfilling lives. But they would be horrified that the drug’s price is now exacting a human price of obscene proportions.

 

 

What Price Life?

Thursday, November 29th, 2018

Part One

“Insulin is my gift to mankind” – Frederick Banting

A Quick Quiz

Question 1: Name a chronic disease requiring medication, which, if not taken every day, guarantees death within two weeks.
Answer: Type 1 Diabetes.

Question 2: Name the medication.
Answer: Insulin.

Question 3: What is the monthly cost of insulin for a Type 1 diabetic?
Answer: As we shall see, that depends.

Question 4: If Type 1 diabetics cannot afford the cost of insulin, without which they will surely die, what should they do?
Answer: This is happening at this moment, and people are dying.  In these two blog posts we’ll examine why and what can be done about it. But we need to first posit some truths about diabetes, and then describe how, in 1922, Canadian doctor Frederick Banting made the ground-breaking discovery that allowed Type 1 diabetics, for the first time in history, to live.

Ten Fast Facts

  1. Insulin is a hormone made by the pancreas that allows the body to use sugar (glucose) from carbohydrates in the food we eat for energy or to store glucose for future use. Insulin helps keeps blood sugar levels from getting too high (hyperglycemia) or too low (hypoglycemia). Type 1 diabetics, T1Ds, can no longer produce insulin. They have none of it. Although older adults can also contract Type 1 diabetes, it usually strikes children and young adults. Without insulin, whether old or young, they die.
  2. There are about 1.3 million T1Ds in the U.S. They comprise one half of one percent of the population. Currently, there is no cure for any of them. Without insulin, they will die.
  3. There are about 29 million Type 2 diabetics. T2Ds still make some insulin. In most, lifestyle changes will improve their health, sometimes to the point where they will no longer require insulin or any other medical prescriptions. Some will become insulin-dependent, and without it, they face life-changing complications.
  4. Diabetic Retinopathy is the leading cause of blindness.
  5. Diabetes is the leading cause of non-traumatic amputation.
  6. Diabetes is a leading cause of heart attack and stroke.
  7. Diabetes is the leading cause of kidney failure.
  8. Complications from diabetes sometimes cause workplace injuries and often exacerbate the severity and length of recovery.
  9. In 2017, the nation’s total direct medical costs due to diabetes were $237 billion. Average medical expenses for diabetics were 2.3 times higher than for non-diabetics. The extent to which diabetes added to workers’ compensation medical costs is unknown.
  10. Based on information found on death certificates, diabetes was the 7th leading cause of death in the United States in 2015, with 79,535 death certificates listing it as the underlying cause of death, and 252,806 listing diabetes as an underlying or contributing cause of death. However, diabetes is underreported as a cause of death; studies have found that only about 35% to 40% of people with diabetes who died had diabetes listed anywhere on the death certificate and only 10% to 15% had it listed as the underlying cause of death. An example of best practice would be, “Death caused by infection contracted from hemodialysis due to kidney failure, a complication of the patient’s diabetes.”

Banting and Insulin

Image result for photo of frederick banting

Frederick Banting is perhaps Canada’s greatest hero. Born in 1891, he graduated medical school with a surgical degree in 1915 and found himself in a French trench by the end of 1917. In December of that year, he was wounded during the Battle of Cambrai, the first great tank battle in history. He remained on the battlefield for 16 hours tending to other wounded soldiers until he had to be ordered to the rear to have his own wounds treated. For this action he won the British Military Cross, akin to America’s Silver Star. After returning to Canada, he continued his studies and, in 1920, secured a part time teaching post at Western Ontario University. While there, he began studying insulin Why? Serendipity. Someone had asked him to give a talk on the workings of the pancreas.

Banting became interested – and then obsessed – with trying to come up with a way to get insulin to people who couldn’t make any of their own. In November 1921, he hit on the idea of extracting insulin from fetal pancreases of cows and pigs. He discussed the approach with J. R. R. MacLeod, Professor of Physiology at the University of Toronto. MacLeod thought Banting’s idea was doomed to failure, but he allowed him to use his lab facilities while he was on a golfing holiday in Scotland. He also loaned him two assistants, Dr. Charles Best and biochemist James Collip. Collip devised a method to purify the insulin Banting and Best obtained from the fetal pancreases.

To MacLeod’s surprise, Banting’s procedure worked, and in 1922 Banting and Best successfully treated the daughter of US Secretary of State Charles Evans Hughes.

In 1923, one year later, Banting, at the age of 32, won the Nobel Prize, which, to his disgust, he had to share with MacLeod. To this day, Frederick Banting is the youngest person ever to win the Prize in Physiology or Medicine.

His discovery could have made Banting mind-numbingly rich, but he would have none of that. Along with Best and Collip, Banting patented his method and then the three of them sold the patent to the University of Toronto for the princely sum of $3.00. When asked why he didn’t cash in on his discovery, Banting said, “Insulin is my gift to mankind.” With Banting’s blessing, the University licensed insulin’s manufacturing to drug companies, royalty free. If drug companies didn’t have to pay royalties, Banting thought they would keep the price of insulin low.

And they did. For decades.

But patents expire, and capitalism being what it is, people get greedy, and greed is why we have no generic, low-cost insulin today and why, over the past 20 years, insulin prices have risen anywhere from 800% to 1,157%, depending on the variety and brand. It’s why, lacking health insurance, some Type 1 diabetics have recently been driven to ration their precious insulin. Some of them have died.

More about all that in Part Two.

 

 

 

Reactions To “Pharma’s Nine Words”

Monday, May 15th, 2017

We received a lot of thoughtful feedback to last week’s post on drug company Direct To Consumer (DTC) television advertising. I thought I’d share a couple that are representative of the whole.

This from a doctor in Florida:

You have acutely illustrated the challenge that allopathic physicians now battle with every day. In short, big Pharma has found a way to circumnavigate the drug salesperson and physician and go directly to the end consumer
Every physician feels significant pressure to satisfy their patients even when the request for certain pharmaceuticals is unreasonable; if the patient walks out of your office empty-handed chances are they won’t come back, so at the very least most patients have some prescription in hand upon their exit.

And this from a C-Suite Chief of Marketing:

I must confess upfront that I was one of those “DTC advertisers” in the early 2000s, having worked with Eli Lilly, Boehringer Ingelheim and Pfizer to name a few former clients.

Over the years I’ve read conflicting studies on DTC’s effectiveness and impact.  This said, there is typically a relationship between the largest category spender and market share.

You may also be interested in a dated survey from the FDA on the subject.  While there are definitely some “pro’s” associated with these efforts, including but not limited to patient empowerment (more prepared for doctor’s appointment, asking thoughtful questions, generally being more involved in one’s health, and better conversations about one’s condition and possible treatments). But there are also some “con’s,” including but not limited to:  overpromises/over statements of a drug’s potential benefits (and a corresponding downplay of possible side effects); pressure on physician’s part to prescribe a patient-requested drug, among others.  (But let’s not forget that there were physicians who were also in pharma’s pockets long before DTC, prescribing certain drugs based on lucrative relationships with companies.  Certainly not all of them… but unfortunately there were – and likely still are – some “bad apples.”)

It will be interesting to see how this debate evolves as baby boomers age.  Let’s hope that the patient is the ultimate winner here!

We can all agree with that last bit about hoping the “patient is the ultimate winner.”

We welcome responsible, thoughtful comments from our readers.

 

 

Pharma’s Nine Words

Thursday, May 11th, 2017

Any idea what the nine most frequently spoken words on US television are? How about:

My doctor said…

Tell your doctor…

Ask your doctor…

These words come at the beginning, “My doctor said,” the middle, “Tell your doctor,” and the end, “Ask your doctor,” of Direct To Consumer (DTC) television advertising with which Big Pharma bombards Americans every day. This is especially true during the morning network shows between 7:00 and 9:00 AM, the evening news hours and the occasionally funny prime time sitcoms that follow. The ads also feature a swell story with great looking actors and sweet music that plays as someone doing a voiceover tells us all about the 25, or so, ways the drug being pushed can kill us.

DTC ads come in many forms, but in 2015  69% of them were television ads with about a third of those coming from Pfizer. These ads have been allowed since the mid-1980s, but gained momentum in 1997 when the FDA relaxed the rules regarding television. Since then, it’s been Katy bar the door.

According to Pharmacy and Therapeutics (P&T), a peer reviewed journal for managed care and hospital formulary management:

The average American television viewer watches as many as nine drug ads a day, totaling 16 hours per year, which far exceeds the amount of time the average individual spends with a primary care physician.5,23,27

Since beginning the recovery from the Great Recession, television DTC has seen staggering growth:

 

 

According to Kantar Media, 72% of the commercial breaks in the CBS Evening News now have at least one pharmaceutical ad in them. These ads have a specific demographic target: Baby Boomers. Until 2012, they were mainly aimed at conditions such as dry eyes, erectile dysfunction, smoking cessation, chronic pain, constipation, heartburn, allergies and cholesterol. But in the last five years, they’ve made a deep dive into cancer, rheumatoid arthritis, and other illnesses to seniors. And, a reflection of our time, Opioid Induced Constipation hit the field during the 2015 Super Bowl. I can still hear the collective national gasp from that one.

Kantar Media reports Pharma spent $6.4 billion on DTC in 2016, with television garnering more than two-thirds of the spend. Since 2012, television spending is up 62%. During that time, the number of drug companies annually spending more than $50 million and the number spending more than $100 million has doubled. For example, last year, makers of Viagra and Cialis spent a combined $306 million convincing older (and increasingly younger) men that without those magic little pills their once prodigious sexual prowess, rapidly approaching Wooly Mammoth-like extinction, will never rise again, literally (but watch out for that 4-hour thing).

And when a new drug hits the market, first year spending can be breathtaking. Consider Opdivo, which debuted in 2015. The drug treats a certain kind of end-stage lung cancer (non-small cell lung cancer), which has a US patient population of less than 200,000. Yet Bristol-Myers Squibb, Opdivo’s maker, spent $93 million marketing it in its first year.

All this money begs an obvious question: Does it work? Well, even Pharma’s not sure, saying ROI is only one measure of a brand’s marketing success. Who is sure? The American Medical Association, which, in 2015, saying it was a colossal waste of money, called for an “outright ban” on Direct To Consumer advertising. The AMA also said doctors felt pressured by vulnerable patients who were looking for relief from one thing or another and that older drugs often work just as well, or even better, than the newer high-priced brands. Of course, it is preposterous to think we’ll ever return to to good old days of the 1980s before DTC advertising became more than a gleam in a marketer’s eye. The drug lobby is nearly omnipotent and there is the  little matter of commercial free speech. Moreover, drug makers claim they are providing valuable information with which consumers can make informed choices. Yet, according to the World Health Organization, “DTC is used to drive choice, not to inform it.”

America is one of only two countries in the world that allow Direct To Consumer drug advertising, the other being New Zealand, a country with a population of less than 4 million. The medical community doesn’t like it there, either.

Pharma has long had a wish to bring DTC to the European Union. That’s not going to be happening, however, as last year 22 of the 27 members rejected the idea.

The P&T white paper, mentioned above is presents an excellent analysis of DTC advertising, and ProCon.org has a nifty for-and-against page regarding DTC advertising. They’re both worth a look.

More on the opioid crisis and the fentanyl factor

Wednesday, May 4th, 2016

Here in the state where the world headquarters of Lynch Ryan is housed, we learn the unsettling news that Massachusetts has seen a 190% increase in opioid deaths in five years. Jessica Bartlett of Boston Business Journal notes:

“Despite Gov. Charlie Baker releasing a $27 million plan to address the opioid epidemic in June, opioid deaths have continued to rise, with recent data from the Department of Public Health showing a 12.5 percent increase in estimated deaths in 2015 compared to the year before.

Compared to just five years ago, the estimated 1,526 unintentional opioid-related deaths in 2015 represents a 190 percent increase.”

Things might have been even worse. In 2015, the “opioid antagonist” Naloxone was administered 12,982 times, so we can only guess what the tally might have been without such intervention. It doesn’t look like 2016 will bring much relief: An estimated 400 deaths have have already occurred in the first three months of the year.

Bartlett notes a disturbing trend:

“While the high number of deaths is nothing new, the state has for the first time released the number of deaths with a confirmed presence of fentanyl, a synthetic opioid 50 to 100 times more potent than morphine.

Of the 1,319 confirmed opioid deaths in 2015, 754 of them tested positive for fentanyl.”

Felice J. Freyer and J.D. Capelouto recently reported on this in the Boston Globe: Fentanyl factored in more than half of 2015 OD deaths, state reports

A Massachusetts law criminalizing fentanyl trafficking took effect in February, with sentences of up to 20 years in prison for selling more than 10 grams.

The health department data released Monday provide the most reliable portrait to date of the opioid crisis in 2015, confirming that 1,379 people died from overdoses. A deeper analysis of cases from 2014 raised the number of confirmed fatal overdoses for that year, to 1,282.

The state’s findings do not distinguish between heroin overdoses and those caused by prescription opioids. Health officials are unable to make that distinction because most prescription opioids, as well as heroin, break down into morphine in the bloodstream. But fentanyl, a synthetic drug, turns into a substance that can be detected by a test.

Southern California Public Radio features a story on Why it’s so hard to track the powerful opioid fentanyl. Rebecca Plevin reports:

First, doctors treating overdose victims are mainly looking for the better-known opioids, like Vicodin. And when they check for drugs, standard tests often miss fentanyl. A special lab analysis is often necessary, and doctors – especially in busy ER’s – don’t always think of that. Another problem is that not all hospitals are set up to conduct the special lab analysis.

All of this is complicated by the fact that illegally manufactured fentanyl may be mixed with heroin or counterfeit pills that look like normal prescription medications, so people may not be aware that they’re exposing themselves to the drug.

The rise in fentanyl use has health officials particularly worried, given its tremendous potency. To try to get a handle on the problem, the state has asked all local hospitals to report suspected fentanyl overdoses. State officials have also asked providers to test for fentanyl when ordering drug screening in cases of suspected overdose.

This is a disturbing news in the worsening opioid crisis. A simple search of Google news will show that officials in Ohio, Pennsylvania and other states are seeing surges in fentanyl overdoses.

In his post Opioids, spines, and dead people, Joe Paduda talks about physicians and prescribing, giving context to the issue:

In a related piece, Michael Van Korff ScD andGary Franklin MD MPH summarize the iatrogenic disaster driven by opioid over-prescribing. Over the last fifteen years, almost 200,000 prescription opioid overdose deaths have occurred in the US, with most deaths from medically-prescribed opioids.

Doctors prescribed opioids that killed well over a hundred thousand people.

Today, about 10 million Americans are using doctor-prescribed opioids; somewhere between 10% – 40% may have prescription opioid use disorder – they may well be addicted.

Van Korff and Franklin note that 60% of overdose fatalities were prescribed dosages greater than a 50 mg morphine equivalent.

In days gone by, drug deaths were primarily associated with illicit or street drugs, but today, it’s prescription drugs – and prescriptions are seen as the gateway to street drugs, rather than the reverse.  We now lose more people annually to drug overdoses than by car crashes or firearms.

In 2013, the most recent year for which data is available, 46,471 people in the United States died from drug overdoses, and more than half of those deaths were caused by prescription painkillers and heroin.

That compares with the 35,369 who died in motor vehicle crashes and 33,636 who died from firearms, as tallied by the federal Centers for Disease Control and Prevention.

Combating the public health scourge of prescription drug-related addiction and deaths will require a concerted effort on all fronts: physicians as prescribers; employers and insurers in the workplace; public health, elected officials and law enforcement in our communities. On that front, there have been some promising approaches in moving from a crime to a treatment approach: Connecticut Cops Consider ‘Angel’ Program to Combat Heroin Scourge

Another approach, pioneered in Gloucester, Massachusetts, shows promise and has been attracting increasing attention around the country. In Connecticut, Groton has adopted it and Manchester is considering a similar program.

Launched on June 1, the Gloucester Angel Initiative makes police the point agency in moving addicts directly into treatment. Addicts are allowed to surrender any drugs and needles they have with the understanding that they will not face arrest and that police and community volunteers called “angels” will help them toward recovery.

About 350 admitted addicts have sought help in Gloucester through the program, department spokesman John Guilfoil said on Jan. 8. As a side benefit, crime fueled by addiction, particularly thefts, dropped 33 percent last summer compared with the summer of 2014, Guilfoil said.

Fifty-three police agencies in the country have adopted similar programs, and two to three more join each week through a partnership called the Police Assisted Addiction and Recovery Initiative, Guilfoil said.

Prior related posts:

 

Studies: Opioid epidemic grows; Is obesity a smoking gun in rise of prescription drugs?

Wednesday, January 13th, 2016

You may have taken hope from studies that pointed to a decrease or leveling of the rate of deaths related to opioid and prescription drug use in 2012-2013. If so, the Centers for Disease Control wasted no time this year in throwing some cold water on those hopes.

On January 1, via the Morbidity and Mortality Weekly Report (MMWR), the CDC issued new data on Increases in Drug and Opioid Overdose Deaths — United States, 2000–2014.

                      Age-adjusted rate of drug overdose deaths and drug overdose deaths involving opioids: US 2000–2014

mmwr opioid trends

Here are some of the key findings:

  • During 2014, a total of 47,055 drug overdose deaths occurred in the United States, representing a 1-year increase of 6.5%, from 13.8 per 100,000 persons in 2013 to 14.7 per 100,000 persons in 2014.
  • Rates of opioid overdose deaths also increased significantly, from 7.9 per 100,000 in 2013 to 9.0 per 100,000 in 2014, a 14% increase.
  • In 2014, there were approximately one and a half times more drug overdose deaths in the United States than deaths from motor vehicle crashes
  • The 2014 data demonstrate that the United States’ opioid overdose epidemic includes two distinct but interrelated trends: a 15-year increase in overdose deaths involving prescription opioid pain relievers and a recent surge in illicit opioid overdose deaths, driven largely by heroin.
  • From 2000 to 2014 nearly half a million persons in the United States have died from drug overdoses.
  • The rate of deaths from drug overdoses has increased 137%, including a 200% increase in the rate of overdose deaths involving opioids (opioid pain relievers and heroin).

The 2013-2014 increase was geographically pervasive. In 2014, the five states with the highest rates of drug overdose deaths were:

  • West Virginia (35.5 deaths per 100,000)
  • New Mexico (27.3)
  • New Hampshire (26.2)
  • Kentucky (24.7)
  • Ohio (24.6).

States with statistically significant increases in the rate of drug overdose deaths from 2013 to 2014 included Alabama, Georgia, Illinois, Indiana, Maine, Maryland, Massachusetts, Michigan, New Hampshire, New Mexico, North Dakota, Ohio, Pennsylvania, and Virginia.

For more analysis of the data, see Kim Krisberg’s story at The Pump Handle.

Obesity: A Smoking Gun?

Is obesity a contributing factor to the opioid epidemic? That’s certainly an avenue worth further investigation. Recent research shows more evidence of the increase in prescription drug use and study authors suggest an obesity connection.

In November, researchers at Harvard’s T.H. Chan School of Public Health issued a report which was published in in JAMA, the journal of the American Medical Association: Trends in Prescription Drug Use Among Adults in the United States From 1999-2012

NPR’s Alison Kodjak reports on the study in Americans Are Using More Prescription Drugs; Is Obesity To Blame?

Two of the key findings:

  • 59% of adults used a prescription drug in a 30-day period, up from 50% a decade earlier.
  • The share of people taking more than five prescription drugs in a month doubled to 15%.

Lead author Elizabeth Kantor said that:

” … the rise in prescription drug use may have to do with the rise in obesity, since many of the most widely prescribed drugs treat obesity-related conditions such as diabetes, high blood pressure, and high cholesterol. The study found, for example, that the share of people using cholesterol-lowering agents, mostly statins, jumped from 7% to 17%.”

 

Related opioid reading matter:

Peter Rousmaniere Takes On The Opioid Controversy And Offers A Prescription For The Future

Monday, June 29th, 2015

Work Comp Central has published We’re Beating Back Opioids – Now What? written by columnist Peter Rousmaniere in cooperation with CompPharma, a consortium of workers’ compensation Pharmacy Benefit Managers.

To say the Mr. Rousmaniere is a “workers’ compensation thought leader” is a little like saying Ted Williams was a pretty good baseball player. In this provocative analysis he expertly  chronicles the increasingly alarming rise in opioid usage to treat work injuries from the early 1990s through the first decade of this century, what he calls “the twenty year crisis.” He describes how Purdue Pharma’s introduction and heavy-handed marketing of Oxycontin in 1996 lit the fuse of the opioid rocket ride to the moon, setting off a series of  cataclysmically destructive personal odysseys on a grand scale. Lives ruined, families torn apart. And he documents the myriad counterattacks mounted by responsible parties around the country, most notably Dr. Gary Franklin, the neurologist and medical director for the Washington State Department of Labor & Industries, who, by anyone’s standard has been a torchbearer in the battle.

Rousmaniere describes how the responsible physician community, recognizing that things were getting more than a little out of control, began to question the effectiveness of opioids in treating pain:

In 2013, the American Medical Association published a review of pain medications, in which it concluded that “Narcotics provide little to no benefit in acute back pain, they have no proven efficacy in chronic back pain, and 43% of patients have concurrent substance abuse disorders, with aberrant medication-taking disorders [in] as high as 24% of cases of chronic back pain.” The “no evidence” concept has been stretched to raise more questions, as in this conclusion published in early 2015: “There is no evidence that opioids improve return to work or reduce the use of other treatments. They may even limit the effectiveness of other treatments.”

Finally, he tells the story of how the federal government as well as almost all the states, the insurance industry, the American Medical Association and workers’ comp pharmacy benefit managers took definitive action to bend the opioid curve to the point where all of the leading indicators have been significantly slowed or reversed.

But Peter Rousmaniere’s report up to this point, the halfway mark, is merely preamble to the real thrust of We’re Beating Back Opioids – Now What? It’s the “Now What?” that concerns Mr. Rousmaniere. The “baby and the bathwater” question. He writes:

The workers’ comp industry was victimized by opioids and their well-resourced purveyors and ardent advocates. But it also made a costly, unforced strategic error. It paid more attention to wrestling with this flawed solution than to the underlying problem: chronic pain.

In short, Rousmaniere says, “We have equated pain management with drug use.” He isn’t shy about making his point:

Too much attention was diverted to fighting the opioid threat. For example, when states introduce hard hitting formularies, such as Texas did and others are doing, hardly any thought is given to making sure patients and physicians have access to a balanced array of non-opioid treatment. This needs to change – now.

Well, chronic pain is real. So, if not with opioids, how should the medical community be treating it?

Rousmaniere’s prescription is an elastic version of conservative care. He describes the approach of California’s second largest private employer, Albertsons / Safeway / Vons, who “learned through experience” that every injured person is a unique individual and that new ideas need to be brought to the recovery process.

For example, it’s almost a cliche  to say that chronic pain sufferers tend to depression as well as other mental and behavioral health issues. Consequently, Cognitive Behavioral Therapy, an underused treatment because of its perceived fuzziness, is gaining traction within the world of claims management.  As is the idea of treating injured workers in a biopsychosocial way. And, because opioid treatment is still an option, many in the medical community are saying that before any injured workers receive opioid prescriptions they should be screened for depression.

Rousmaniere argues persuasively that “one size fits all” treatment just doesn’t work for many people and that the solution to this thorniest of workers’ comp problems will take a heretofore unheard of level of cooperation and coordination among and between the industry’s disparate factions. He even goes so far as to compare the effort required to the largest single public infrastructure project in the nation’s history, Boston’s Big Dig. Although, having lived through the Big Dig and its daily remapping of Boston’s streets, that’s a bit of a long pull for me. But I get his point:

The goal of the Big Dig was to improve the livelihood of the Boston metropolis – more than reworking traffic flow. The goal of a chronic pain initiative is to keep workers productive – more than managing drugs.

Peter Rousmaniere’s  We’re Beating Back Opioids – Now What? is a compelling, stimulating and thought provoking work by a person with 30 years in the workers’ comp trenches and the scars to prove it. It should be required reading for anyone whose job it is to help injured workers return to the productive future each deserves.

 

 

An Opioid Call To Arms

Wednesday, April 30th, 2014

In October, 2013, the Food and Drug Administration (FDA) allowed the opiate Zohydro ER to come on the market despite its own Advisory Panel voting 11-2 against it because it was not tamper resistant. Twenty-nine state Attorneys General petitioned the FDA to reverse its decision, but the FDA declined to do so, saying that the drug is safe and effective if used as directed.
We chronicled Massachusetts Governor Deval Patrick’s Quixote to the Windmill charge as he attempted to ban the sale of the drug in the state. The windmill won when US District Judge Rya W. Zobel overturned the state’s ban. Shortly thereafter, just days before his ban was due to expire, Governor Patrick remounted Rocinante and made a less Quixotic charge: he followed the lead of governors in other states by imposing sweeping restrictions on how Massachusetts doctors prescribe the powerful pain killer, the first pure opiate.
The restrictions, which Zohydro ER’s maker, Zogenix, calls “draconian” and “unjstified,” require that doctors:

  • Evaluate a patient’s substance abuse history and other current medications;
  • Provide a “letter of medical necessity” to the pharmacy;
  • Enter a “pain management treatment agreement” with the patient; and,
  • Use the state’s online Prescription Monitoring Program, which tracks prescriptions of controlled substances, before prescribing drugs like Zohydro that are extended-release medications containing only hydrocodone and do not come in an “abuse-deterrent form.”

Zogenix is fighting back. On Monday, the San Diego-based company filed a federal lawsuit arguing that the Massachusetts new restrictions impose “draconian” mandates on doctors and “amount to an effective ban of the drug” that is unconstitutional.
The Suit asks that the Court vacate any restrictions imposed on the sale of Zohydro ER.
Governor Patrick says that his problem with Zohydro ER is that it does not come with “abuse deterrent” packaging. Zogenix responds with three assertions:

  • The active ingredient in Zohydro ER, hydrocodone bitartrate, is no more potent than most other opioids;
  • There are more than 30 extended-release opioids on the market, and only one has an FDA-approved label indicating it has abuse deterrent properties; and,
  • No product on the market today addresses the most prevalent form of abuse, taking an excessive number of tablets or capsules.

Yesterday, things got even hotter in the Bay State when drug abuse prevention groups, state lawmakers and organized labor leaders rallied outside the statehouse on Beacon Hill demanding even more restrictions.
The rally drew more than 150 demonstrators who, in addition to the call for greater restrictions, urged Congress and federal officials to reverse the FDA’s approval of Zohydro ER.
Those who attended the WCRI’s annual conference in Boston in April will recall the stemwinding luncheon speech of Steve Tolman, former Massachusetts state Senator and now President of the Massachusetts AFL-CIO. Tolman, who ardently and passionately does all he can to combat drug abuse in the Commonwealth, was in rare form at yesterday’s rally.
“We don’t need any more opiates! We don’t need any more addiction,” he shouted to the crowd. “Yes, we know that people need pain medication, but they need the right type of medication. And it needs to be monitored.”
Massachusetts Senate President Therese Murray promised the demonstrators that the legislature will take action and is now working on a comprehensive bill dealing with all aspects of addiction, from education to prevention to treatment.
But, with the exception of theft, the only way people get opioids is by doctors prescribing them, and, right now, doctors are cautious and, in some ways, befuddled. They know there’s a big opioid problem, which has prompted Governor Patrick to declare a state of emergency, but they don’t want government invading their patient examination rooms. Nonetheless, shortly after the Governor announced his restrictions, the Massachusetts Board of Registration passed emergency regulations adopting them.
Moreover, in this week’s New England Journal of Medicine, Doctors Yngvild Olsen and Joshua M. Sharfstein present a thoughtful op-ed focused on Zohydro ER and the greater issue of the intersection of chronic pain and pain management medication. They write:

Chronic pain, which affects tens of millions of people in the United States, is associated with functional loss and disability, reduced quality of life, high health care costs, and premature death. U.S. physicians are now more likely to recognize and treat chronic pain than they have been historically, with the number of prescriptions written for opioids having increased 10-fold since 1990.

Over the same period, however, the rate of overdose deaths in the United States has more than tripled. This is not a coincidence. Many doctors have prescribed opioids for chronic pain without following best practices, understanding the risk for the development of substance-use disorders, or recognizing the red flags that can emerge in clinical practice. There is now evidence from states including our own, Maryland, that some individuals whose path to addiction may have started with a prescription for pain are progressing to heroin.

It is becoming crystal clear that re-educating doctors regarding opioid usage is central to any attempt to fix this problem.
It is also clear that this crisis is not about Zohydro ER, although the drug may prove a catalyst for change. Rather, we are witnessing a growing countrywide realization that we are slipping into a public health crisis unlike anything we have ever seen.
In the workers comp field, there is a glimmer of hope. Progressive Medical and PMSI yesterday reported a slight drop in the number of opioid prescriptions written, as well as the costs of those prescriptions in 2013. Other PBMs are reporting similar moderate declines. But that is workers comp, the tiny caboose on the great big health-care train.
This issue demands more than the piecemeal approach it now is getting. Lives, careers and families are being destroyed, while too many constituencies operate alone, unable to achieve any kind of a cohesive and comprehensive solution. It is time for the FDA, the AMA, the US Congress and Big Phama to come together in serious purpose to address this public health emergency, which is rapidly spiraling out of control.
If not, more of America’s humanity will just continue to wither and die. We are better than that.