Posted on | November 23, 2015 | No Comments
The Man-made American Opioid Epidemic represents a supply chain failure and a management challenge if system flaws are to be corrected. In its simplest terms, the process involves approval, production, distribution, prescribing, dispensing, and consuming. For all pharmaceuticals, the goal should be to personalize and customize the prescription with the intent of maximizing benefit and minimizing risk. For opioids specifically, the goal should be to appropriately and wisely meet the requirements of patients with pain, while maintaining a series of safeguards to prevent, correct and treat misuse, abuse, disability and potential intentional or accidental death from overdose.
Process analysis and oversight require real time access to data. Up till now, the only ones who have had it, through a cooperative arrangement that has included the AMA, were the pharmaceutical companies. Clearly, the lack of coordinate access to information has been a well-known, and not infrequent, fatal flaw in America’s fiercely independent and dis-integrated health care system. This system has placed the highest value on professional autonomy, featuring largely self-regulating physicians, empowered to make independent decisions for, and sometimes with, patients. Since World War II, the profession’s most potent instrument, and most jealously guarded right, has been the license to prescribe medications.
This highly vaulted system has now allowed a level of abuse in consumption of opioids sufficient to bend the survival curve of white middle aged males in America. As laid out in Part 2 of this series, automated Prescription Drug Monitoring Programs (PDMPs), where utilized, as in Kentucky, have proven effective in stemming abuse, saving lives, and saving money.
The need for PDMPs, which rely on real time downloads from multiple databases, reflects existing deficiencies in the system of medical regulation and oversight. For example, large nationwide pharmacy chains electronically track and survey controlled substance prescriptions to detect prescriber or consumer abuse. But they only have access to those prescriptions filled in one of their own stores. Similarly, insurers or their agents, Pharmacy Benefit Management (PBM) companies, track claims data for abuse, but they can not detect prescriptions paid for with cash. Federal programs, like Medicaid, Medicare, VA, DOD, and Indian Health Service are unable to track purchases made in cash outside their benefits programs, and usually do not share data with the new PDMPs. Finally, state PDMP’s are not yet fully integrated with each other forming a seamless, reliable network nationally for analysis and oversight.
Though certainly imperfect and incomplete, PDMP’s, which exist in 49 states, as well as existing databases controlled by insurers, PBMs and pharmacy chains, maintain moderately effective programs to detect the most egregious opioid abusers. For example Oregon zeroed in on just 4% of the state’s prescribers because they were generating 60% of the prescriptions for controlled substances. And one national pharmacy chain uncovered 42 prescribers, each on average generating some 5000 scripts for controlled substances per month.
While criminal “pill mills” certainly do exists, the issues that have generated the current opioid crisis are far more systemic and involve long-standing, generalized, widespread, and inappropriate overprescribing of powerful pharmaceutical agents with and without high abuse potential. These insights, long suspected, will increasingly be revealed by newly established PDMPs, and shine a glaring light on the dysfunctional relationship between producers of pharmaceuticals and prescribers of pharmaceuticals.
A Johns Hopkins consensus paper revealed that proactive investigatory data analysis is now conducted by PDMPs in 26 states. Only four of those states are currently distributing algorithm driven analytics to prescribers, pharmacists, professional licensing boards and law enforcement agencies without request. But this aggressive approach is likely to spread rapidly to include most states within the next 12 to 24 months. In 32 states, some insurers are permitted to access PDMP databases, and licensing boards currently have unimpeded access in 46 states. Five states are analyzing Medicare prescribing data as well. A PDMP Center of Excellence has been established with joint funding from the CDC, FDA, and Justice Department.
While the careful tracking and analysis of prescription patterns is a relatively new capability among insurers, regulators, and law enforcement agencies, it is old hat to pharmaceutical companies. Some 60 years ago, the enterprising leadership of IMS Health began to collect raw data from pharmacies to spreadsheet and resell to pharmaceutical sales teams. The broad numbers of products sold in a region were valuable, but what the sales teams really needed was the number of scripts for each of their products written by each specific physician.
To achieve that level of granularity, the IMSs of the world needed identifier numbers for the physicians. As it turns out, the AMA possessed those numbers in what was termed the Physician Masterfile, and were willing to sell the database. The identifiers were controlled by the Liaison Committee on Medical Education (LCME) and the Accreditation Council for Graduate Medical Education (ACGME) which agreed to provide them to the AMA years ago. When physicians enter medical school or enroll in a residency program anywhere in the US, they receive a ME (medical education) number. That number is a lifelong tracker and the key to identifying future prescriptions written by those physicians in real time.
For the pharmaceutical industry, such information is a gold mine. That’s why, by 2005, as sales of Oxycontin (the premier prescriptive opioid at the center of this epidemic) exploded, IMS Health had revenues of $1.75 billion, and why the AMA charted a profit of $44 million that same year from the licensing of their Physician Masterfile to a wide range of interested parties. In the wake of criticism, the AMA created a set of voluntary guidelines for manufacturers and a process for physicians to opt-out of the Physician Masterfile on request.
The clear purpose of the pharmaceutical industry’s purchase of refined prescriber data from IMS Health and others was to inform their sales detailing, and sell more drugs. They have no vested interest in critiquing the appropriateness of prescribing practices. Over the past two decades, pharmaceutical prescribing has markedly liberalized with deliberate widening of indications, expanded use of pharmaceuticals in children, medicalization of behaviors to achieve “disease status”, and creation of pharma-funded medical research and CME organizations and patient advocacy groups who, in return for funding, willing support industry goals. These industry actions have had a single, consistent over-arching purpose – to sell more drugs.
What the PDMPs have revealed for opioids, and will soon reveal quite glaringly for a range of other agents, most notably psychiatric drugs, is that industry, in partnership with many physicians and medical institutions and member organizations, have been fabulously successful in expanding profitability and patient risk over benefit. In response, the PDMP empowered regulatory bodies will increasingly push back.
What might be expected policy wise, at minimum in the near future? Expansion of the scope of practice of pharmacists; elimination of DTC advertising which has little/no value in this modern era; the end of detailing and physician prescriber level data mining; and expanded strategies to disrupt the six decade old, self-enriching financial relationship within the Medical-Industrial complex in America.
In Part 4 of this 5-part series, I’ll explore the origins of this relationship in the immediate post-WWII period, and share the story of a single widely celebrated physician who was responsible for modern day pharmaceutical advertising tactics, facilitated drug reliance in behavioral health care, and created an addictive agent (by manipulating a WWI vintage generic product), which ignited the current opioid epidemic.
Posted on | November 19, 2015 | 2 Comments
In part 1 of this 5-part series, the focus was on responsibility, which is multiple and shared by pharmaceutical companies, physicians and their representative organizations, state legislators and state medical boards coerced to ease regulatory oversight, and criminal profiteers. The scope of the problem was also writ large: a 5-fold increase in opioid related overdose death rates since 1980; 2.1 million opioid addicts, and an additional 2.5 million pain patients “who may be suffering from an opioid use disorder”.
In a landmark effort by Johns Hopkins to assess the problem, it was clear at the outset that:
1. An overwhelming majority of the prescription drugs abuse in this opioid epidemic originate from legitimate physician prescriptions.
2. Prescription opioids are frequently diverted to others illegally.
3. 70% of those abusing prescription opioids accessed their most recent supply through a friend or family member.
Can we track the early movement of this “abuse trail”, from health prescriber to prescription to patient to acquaintance? If so, where do we start? Well, the good news is we are not starting from scratch. According to the Hopkins study, there are 51 Prescription Drug Monitoring Programs (PDMPs) in the US and territories. Almost every state (except Missouri) has one. State controlled and regulated, almost all collect precription data from state pharmacies and most also capture prescriptions drugs imported into the state through mail order outlets.
Health professional prescribers and pharmacists can access these state databases to check on a potential abusers activity (at least in that one state). Drug name, dose, quantity, and date. It’s all there in black and white. But studies show that about half of physicians have never accessed their state PDMP and over a quarter don’t even know it exists. Pharmacists are much more likely to access PDMPs. For example, a study of Indiana pharmacists found that 94% were aware of the program, and 71% had accessed it. What prevents prescribers and pharmacists from accessing PDMPs? Studies reveal a range of deterrents including time required, legal ramifications, and absence of reimbursement for the activity.
The value of PDMP’s is well-established, were they to be utilized properly. Here is a list of deliverables:
1. Reveals multiple doctor and pharmacy shopping.
2. Reveals prescription forgery.
3. Reveals risk of addiction or overdose.
4. Can quantify potential risk of overdose (7X normal for doctor shoppers; 13X normal for pharmacy shoppers; 9X normal for those with daily use 100mg morphine equivalents).
Faced with this well publicized crisis, and a potential (at least partial) solution, states have begun to catch up. A few examples from the recent Johns Hopkins study:
1. 36 states now allow precribers “delegates” to access PDMP information for them.
2. 16 states have grants to integrate PDMP databases with their ACA health information exchanges and EHR record system.
3. PDMP “Push Reporting” is beginning. Database managers push reports of potential abusers to prescribers, unsolicited, for their review. Early reports show prescriber acceptance and utilization of this technique.
4. Move toward real-time data collection. 22 states now require daily downloads. 27 others require weekly downloads.
5. 11 states have comprehensive mandates that PDMPs be accessed when opioids are prescribed. 16 other states mandate access under certain circumstances.
6. 28 states are experimenting with sharing of interstate PDMP data.
The Hopkins study reviews in detail the benefits that accrued to Kentucky, the first state to mandate prescribers comprehensive access of their PDMP. Their clinicians are required to check the PDMP before a patient’s first opioid prescription, and every three months after for continued refill. What happened?
1. Opioid prescriptions dropped 8.6% in the first year.
2. Opioid overdose hospitalizations decreased 26%.
3. Opioid related ER visits dropped 15%.
4. Prescription opioid deaths dropped 25%.
In Part 3 of this five part series, the role of pharmacists and Pharmacy Benefit Management organizations will be explored.
Posted on | November 18, 2015 | No Comments
As we learned last week, the opioid epidemic that we’ve been debating for a decade, which has been largely fueled by prescription drugs, has now managed to bend the survival curve for middle aged white males in America. And there’s plenty of blame to go around.
There’s the pharmaceutical companies that marketed products as addiction proof when they were not, and funded medical professional and consumer organizations to advance the cause of a pain free society at any cost. Their mantra: “pain” is the 5th vital sign.
There’s the medical community that endorsed new societies of pain specialists, with pharmaceutical employees on their boards, and published a stream of liberalizing pain management papers in their peer reviewed journals.
There’s the 20 state medical boards and state legislatures, which in response to active lobbying by the pharma-funded medical organizations, for the first time, lifted all regulatory prohibition on the use of opioids for non-cancer chronic pain management. As one state statute made clear in 1999,“no disciplinary action will be taken against a practitioner based solely on the quantity or frequency of opioids prescribed.”
There’s the lobbyists like Rudolph Guiliani, who went over the heads of federal prosecutors in 2002 and accessed friends in the Justice Department to shut down efforts to prosecute firms the were knowingly profiting from the drug trade.
There’s the countless primary care and specialty clinicians who drank the Kool-Aid presented by pharma-supported “pain specialists” and freely prescribed without question, reassuring some, and turning a blind eye to others.
There’s the unfortunate patients who got hooked, and the bad actors that crushed, repackaged, and pushed their wares in the secondary sale street market.
And there’s the heroin dealers, who came in on the back end, with new demand for opiates already well established, to fill in the gap when it became more difficult to find prescribed pills on the street.
But for the moment, let’s not dwell on who’s to blame. How big is the problem, and what can be done now that over 100,000 people have been lost in the past 15 years? That’s the philosophy embraced by a new Johns Hopkins report on the topic titled “The Prescription Opioid Epidemic: An Evidence Based Approach.”
It begins with a blistering critical assessment of the effectiveness of “pain specialists”, their societies, and their ambitious pharma-supported advocacy. Here’s what the report states:
“These systematic reviews concluded that the overall effectiveness of chronic opioid treatment for chronic non-cancer pain is limited, the effect on improved human function is very small and the safety profile of opioids is poor. Briefly stated, the evidence on efficacy and effectiveness of these drugs for chronic non-cancer pain has demonstrated:
1. A variety of adverse events associated with opioid use, including: hypogonadism and infertility; neonatal abstinence syndrome; sleep breathing disorders; cardiac arrhythmias; opioid-induced hyperalgesia; and falls and fractures among the elderly;
2. High rates of healthcare utilization associated with these adverse events, including emergency department visits and hospitalizations from non-fatal overdoses;
3. High rates of deaths from unintentional poisonings, especially at doses at or above 100–120 morphine milligram equivalents (MME) per day, which generally occur at home during sleep;
4. Minimal improvement in pain and function associated with long-term opioid use for chronic non-cancer pain; and
5. An overall unfavorable risk/benefit balance for many current opioid users.
….. position papers of expert groups differ, as does the soundness of their recommendations, including some recommendations under investigation by the U.S. Senate at the time of this writing.”
How big is this self-made problem? Again, Hopkins reports:
“Drug overdose death rates in the U.S. increased five-fold between 1980 and 2008, making drug overdose the leading cause of injury death. In 2013, opioid analgesics were involved in 16,235 deaths — far exceeding deaths from any other drug or drug class, licit or illicit. According to the National Survey on Drug Use and Health (NSDUH), in 2012 an estimated 2.1 million Americans were addicted to opioid pain relievers and 467,000 were addicted to heroin. These estimates do not include an additional 2.5 million or more pain patients who may be suffering from an opioid use disorder because the NSDUH excludes individuals receiving legitimate opioid prescriptions.”
What’s to be done? In the next four Health Commentary reports, I’ll address four active areas that show promise:
1. Prescription Drug Monitoring Programs linked with mandatory electronic prescribing for opiates.
2. Roll-backs on liberalizing statutes and regulations governing prescribing of controlled substances.
3. Active oversight involvement of Pharmacies and Pharmacy Benefit Managers in the prescription use and abuse of opioids.
4. New technologies that should help track the movement and impact negligent or criminal distribution of prescription opiods.
Posted on | November 13, 2015 | No Comments
The results of the recent 2014 CDC survey of childhood developmental diasabilities, on first glance last week, turned more than a few heads. The dramatic, but simplistic take-away was that lifetime prevalence of autism spectrum disorder (ASD) had jumped from 1.25% based on data from 2011 to 2013, to 2.24% based on 2014 data. But most of the headlines were far more nuanced, thanks to a careful and complete interpretation of the changes by the CDC.
It turns out that the methodology of the survey instrument had been fundamentally changed in order to bring the CDC survey and its’ wording more in line with other similar surveys by other branches of government including HHS and HRSA.
As the illustration above shows, the earlier study included autism spectrum disorder in a group of ten alternatives in a third level of questioning. In the more recent study, Autism spectrum disorder was isolated and featured on the second level of questioning. An elaborate analysis of the complete databases of both surveys led statisticians to the conclusion, “ The revised question ordering and new approach to asking about developmental disabilities in the 2014 NHIS likely affected the prevalence estimates of these conditions.”
The new estimate of 2.24% is now in line with other estimates in governmental surveys. In addition, the CDC will be using the 2014 methodology in future studies as a benchmark for assessing any future changes in incidence. The extreme interest in trend lines for ASD reflects the fact that the cause of this strange and tragic condition remains unknown.
1. The condition is diagnosed more often in boys than girls, but that is changing. The earlier study labeled 82% as male, while the 2014 study identified only 75% male.
2. Most of those diagnosed are white (60%). 13% are black and 16% hispanic.
3. Most of the kids come from two parent families (68%).
4. The wealthy are at least as likely to have a child with ASD as poor parents. 22% are below the poverty level; 25% at one to two times the poverty level; 32% at two to four times the poverty level; and 21% more than four times the poverty level.
5. Most of the kids come from well-educated households. Over 2/3 of the parents have at least one parent with more than a high school education.
6. Geographic distribution is relatively balanced: South, 31%; Midwest, 26%; West, 22%; Northeast, 21%.
7. Most experts believe that a combination of genetic and/or environmental factors before, during and immediately after birth will eventually be found to be responsible for ASD. Vaccines as causal have been repeatedly ruled out.
Posted on | November 9, 2015 | No Comments
In the November 10th issue of JAMA, devoted to cardiovascular disease, David Bluemke, NIH Director of Radiology and Imaging Sciences, and his team, revealed a set of findings certain to draw mixed reviews from health economists and policy professionals. It seems that quite a few more people than we had realized are walking around with scarred hearts (from myocardial infarctions in the past).
Now depending on whether you are generating a bill or paying for it, this is happy or sad news. But first a few facts from the study. The study involved 1,840 men and women, ages 45 to 84, from six US communities, and lasted a decade. The focus was on undiagnosed heart attacks. For these people, the symptoms were too mild or entirely absent to draw much attention. So they were ignored, and life fortunately went on.
Now this is not a new phenomenon. In fact, a group in 2002 checked out a population of heart attack patients, and reviewing their old ECG’s, determined that 20% had evidence that their previous heart attacks had gone undetected.
At the same time, experts have also been aware for some time that the ECG is not a perfectly sensitive test of heart muscle damage. In fact, smaller scars that result from limited episodes of ischemia caused by blocked cardiac arteries can be easily missed by the classic ECG. That is why, in this study, the NIH investigators turned up the dials and used enhanced MRI’s to look for scars – even small ones.
The group of patients all had one thing in common – they had complained of heart problems. And in response all received standard ECG’s and blood work during the ten year period. They appeared fine. Then, at the ten year mark, all received their MRI’s. The sensitive test found that 8% of them (146 people) had scarred hearts, and 78% of those weren’t aware of having ever had a heart attack. This included 13% of the males in the study and 2.5% of the females.
The incoming president of the American College of Cardiology, Richard Chazal, telegraphed a potential change in practice when he said of the study, “It’s almost like having looked at a petri dish with a magnifying glass, and then having the availability of a microscope. All of a sudden you can see things that you couldn’t see before.”
But the question is, Do we really want to know? Is this endpoint worth detecting? It’s pretty easy to predict what will happen next. Some doctors, including perhaps those with financial ties to imaging centers, will be doing many more enhanced cardiac MRI’s. Symptomless patients, especially those with great insurance or the financial means and an obsession about their own mentality, will be urgently requesting these exams. And at the end of the day, we will retrospectively, as with the PSA for prostate cancer, have to sort out whether knowing something adds or detracts from quality of life.
Posted on | October 27, 2015 | No Comments
JAMA Health Statistics 1969 vs. 2013 (death rates per 100,000)
On the positive side….
Death Rate Overall ⬇ 42.9%
Death from Stroke ⬇ 77.0%
Death from Heart Disease ⬇ 67.5%
Death from Cancer ⬇ 17.9%
Death from Diabetes ⬇ 16.5%
On the negative side….
Death from COPD ⬆ 100% (21 to 42/100,000)
Posted on | October 27, 2015 | 2 Comments
On September 23, 1988, I had my first experience with the pressures of a full blown press conference. I was the chief administrative physician at Baystate Medical Center in Springfield, Massachusetts. Our governor, Michael Dukakis, was running for President of the United States, at the same time (as it turns out) that his State Police Academy was running wild.
The cause for the press conference that Friday afternoon was a deadly combination of heat, overexercise, and physical abuse sanctioned and orchestrated by those in charge of the Massachusetts State Police Academy in Agawam, MA, on September 17, 1988. Our assessment a week later of the 51 victims, one of whom would eventually die of massive liver and kidney failure, was that this was the result of a lethal combination of heat, overexercise and dehydration. My public report on camera that afternoon was met with a stern reproach by leaders of our Health System, some politicians, and members of the Dukakis administration. A cover-up by the State Police, who originally suggested the possibility of contaminated water as the cause, was soon revealed. A month later, a full recounting in People magazine confirmed our initial diagnosis, and added as well documentation of extreme physical and verbal abuse that day.
In any case, from that day forward, I’ve been especially conscious of the danger of heat to humans. And so, yesterday, I read with interest on Discovery.com the dramatic headline, “Burning Hell Coming For Mideast Deserts”. The article, based on a recent report in the journal, Nature Climate Change, first exposed me to the term, “wet bulb temperature”. And then today, the New York Times followed up with an article focused on the term called “The Deadly Combination of Heat and Humidity”.
As it turns out, the proper term is “wet-bulb globe temperature” and it was first used in the 1950’s by the U.S. military. The Army and the Marines were attempting to limit the degree of trainee casualty due to heat stress. They had noted that heat measures alone were not an adequate predictor of problems. They sought a measure that would consider humidity as well. So they wrapped a thermometer in a wet cloth, and then took a measure. They then conducted epidemiologic studies and pegged the critical point where injuries began to appear. But, for some reason, wet-bulb temperature measurements and findings never quite made it onto our athletic fields or public health departments.
According to one emergency physician at George Washington Univesity School of Medicine, beyond a certain point, “your body doesn’t cool anymore” (from sweating). So what is that point? Well that depends on what you’re doing. If you are exercising, your body loses the ability to cool itself through sweat evaporation at a wet-bulb temperature of 80. That same person sitting quitely in the shade will first experience problems at a wet-bulb temperature of 92, and if he sadly falls asleep there, under the tree, at a wet-bulb temperature of 95, he’ll die in six hours. In the Nature Climate Change study, the authors demonstrated that the recent 1.5 degrees of global warming had already resulted in a quadrupling of the likelihood of experiencing exposure to deadly wet-bulb temperatures.
The number of days in danger per year has been averaging four, but if current global warming treads persist, we will experience on average 10 such days per year by 2030. That will seem mild compared to the 17 days in 2050, and even more so compared to the 35 days in 2090. To put some human terms to all this, consider the death rates with heat spells in our recent history: July, 1995 (Chicago) – 700 deaths; August, 2003 (Europe) – 45,000; July, 2010 (Russia) – 54,000. Not small numbers.
India hit a regular temperative of 118 degrees last week with 2500 casualties, which likely triggered the “Burning Hell Coming for Mideast Deserts” article. As one of the Nature Climate Change authors said, “People who have resources will live indoors.” Of course, generating the electricity for air conditioning carries with it a carbon footprint which could make global warming worse. And if you’re poor, you’re out of luck, and on the move to anyplace that’s cooler. Speaking of migration, cultural and historical events like the annual outdoor Muslim pilgrimage to Mecca, Saudi Arabia, could become untenable. The same may be true of oil exploration as equipment breaks down and mechanics can’t function in the extreme heat. If you believe the Middle East is unstable now, don’t expect relief any time soon.
The wet-bulb temperature sets the limits of human tolerance. And clearly human behavior is magnifying our population risks. If we begin to act rationally and adopt policies that lower carbon emissions, we will create for ourselves a range of options and greater freedom. If we persist as we have, expect change similar to what the Massachusetts police cadets experienced in 1988. And as a doctor with first hand exposure to that event, let me tell you, it was not a pretty picture.keep looking »