Relevant and even prescient commentary on news, politics and the economy.

Opioids, the Quiet Killer

There are no loud guns shots in the middle of the night. No screams for help or sounds of cars speeding away. No police sirens or flashing lights. It is pretty quiet when someone ODs on Opioids unless someone finds them before it is too late.

As I wrote earlier; “From 2006 to 2015, pharmaceutical companies spent $880 million in lobbying state and federal legislatures and contributing to campaigns to prevent laws restricting Opioid prescriptions. Opioid manufacturer lobbying expenditures has outstripped those such as STOPPNow advocating for greater controls on Opioids and prescriptions by 200 times at the state level.”

In comparison, only the NRA and its gun lobbying efforts in legislatures displays a similar capability to oppose and defeat any and all laws for bullet-spewing-weapons laws the same as the Opioid industry efforts to block legislation. Legislators pay attention when either industry or lobby calls on them.

Any particular article advocating greater regulation of Opioids or reporting of Opioid dangers on medical blogs such as Medscape, centers such as Public Integrity, news agencies such as Associated Press are met with a resistance (if they still have a comments section) the same as what is found on sites when they advocate for greater “gun control.” The evidence is overwhelming that there is an opioid epidemic in the nation resulting from usage and is similar to the epidemic of injury and deaths resulting from guns. Quietly, the industry and their lobbyists work the legislatures to stymie any effort to control opioids.

Latest Findings by the CDC

Today, Medscape reported:

Emergency department (ED) visits for suspected opioid overdoses rose by 30% throughout the U.S. in a year, according to the CDC.

“All five regions of the U.S. saw significant increases during this time period,” said Anne Schuchat, MD, acting CDC director, in a CDC tele-briefing Tuesday.

If you come back later to Medscape article, you will see the comments section flooded with what appears to be an organized opposition to what supported facts MedScape presents and consequently any and all suggested Opioid control. Many of the posters appear to be the same ones time and time again. It is pretty apparent the pharma industry is attuned to any medical backed article going up advocating for Opioid control.

The analysis backing the increase in Opioid ER visits can be found in a new CDC Vital Signs report. The basis of its findings are from ~91 million ED visits in 52 jurisdictions in 45 states from July 2016 to September 2017. The data is reported in the CDC’s National Syndromic Surveillance Program (NSSP) Biosense Platform. The 142,557 visits to the ER reported as suspected opioid overdose cases equate to a 29.7% increase from the previous 1-year period.

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1000% increase in Drug Addicted Babies in Florida – 2016

Janet Colbert of Stop The Organized Pill Pushers Blog:

“The death rate from Opioids continues to escalate year over year due to Florida ignoring the opiate epidemic for so long. Since STOPPNow (Stop The Organized Pill Pushers) started posting, the death rate went from 7/day in Florida. to 14/day. To keep the pressure on the legislature, I (Janet Colbert) will keep the Stoppnow.com site updated when we have bills that will need support to become law.”

Janet Colbert is a Neonatal Nurse in a Florida hospital caring for newborns who are addicted to opioids at birth.

Sun Sentinel; Gov. Rick Scott has called for $50 million and new legislation to fight the opioid abuse epidemic that has killed hundreds and overwhelmed morgues in South Florida.”

Click on the picture to enlarge it.

If you recall my way-to-long post: How Pharma Influences . . .

The first line of the post:

From 2006 to 2015, pharmaceutical companies spent $880 million in lobbying state and federal legislatures and contributing to campaigns to prevent laws restricting Opioid prescriptions. Their lobbying expenditures has outstripped those advocating for greater controls on prescriptions by 200 times giving them greater influence at the state level.

Pharmaceutical companies spend almost twice as much every year as compared to what Florida will spend to fight the Opioid epidemic in Florida over a period of time.

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Big Pharma Influence in State, Federal Government, and Everyday Life

How Pharma Influences Legislation They Do Not Like

From 2006 to 2015, pharmaceutical companies spent $880 million in lobbying state and federal legislatures and contributing to campaigns to prevent laws restricting Opioid prescriptions. Their lobbying expenditures has outstripped those advocating for greater controls on prescriptions by 200 times giving them greater influence at the state level.

In 2015, 227 million prescriptions were written for opioids such as OxyContin, Vicodin, and Fentanyl. This was enough prescriptions to give nine of ten adults a bottle of pills. With its aggressive lobbying, the pharmaceutical industry maintains the “status quo of aggressive prescribing of opioids and reaping enormous profits” according to Dr. Andrew Kolodny of Physicians for Responsible Opioid Prescribing.

Opioids are used to interact with the receptors (protein molecule that receive chemical signals from outside a cell causing a cellular/tissue response) in the body. They work with sites in the brain and nervous system known as opioid receptors to stop pain messages from reaching the brain effectively telling you to not feel pain. Opioids are used to counter pain from injuries, surgery, and chronic pain.

While campaigning for a law limiting the initial prescription quantity of an Opioid, Jennifer Weiss-Burke came to realize the strength of the pharmaceutical lobby in New Mexico. Her son Cameron was sent home with a bottle of Percocet to combat and dull the pain from a broken collar bone. A few years later, Cameron died of a heroin over dose.

Jennifer Weiss-Burke had lobbied the New Mexico legislature to limit “initial” pain-killing opioid prescriptions to seven days outside of the needs of chronic pain patients. The bill died in the New Mexico legislature. There was no open discussion of its merits, suggested improvements, proposed compromises, or discussed safeguards to protect those using Opioids for chronic pain. Instead, the Pharmaceutical Lobbyists privately called on each legislator to discuss why they should oppose the bill Weiss-Burke was advocating.

One of the manifestations of substance abuse in New Mexico was prescription drug overdose death. It was not a significant problem ten years before; but, it was developing and unidentified as a significant problem. In 2011, Cameron Weiss Burke died of a heroin overdose. Between 1992 and 2013, New Mexico was at or near the top for drug overdose deaths nationwide. In 2013, New Mexico had a drug overdose death rate of ~ 22 per 100,000 ranking third nationally behind West Virginia and Kentucky (CDC). Yet, the New Mexico legislature chose not to react to this plague and take action?

The pharmaceutical industry is profitable and wields influence across both sides of the aisle in
Congress and at the state level. In the past its lobbying efforts paid off with Congress blocking Medicare, Part D, and the ACA from negotiating directly with Pharma on pricing. Just how strong and profitable is pharmaceuticals? As Dr. Perry Wilson explains; “Different chronic diseases have different patterns of price increases. The biggest increase was seen in diabetes care (1993 – 2013) and driven largely by the rising prices of pharmaceuticals” of which the cost of manufacturing did not increase. Now Secretary of HHS, Alex Azar as the CEO of Eli Lilly raised the price of the century old drug Humalog used to treat diabetes by 345% taking it from $2,657.88 per year to $9,172.80 per year.

With greater profitability comes the ability to employ lobbyists who can call on state and congressional legislators. The Opioid industry, associated companies, and their allies have contributed to many candidates at state-level offices and employ an army of lobbyists covering the 50 state legislatures. From 2006 to 2015, the Pain Care Forum, a loose coalition of drugmakers, trade groups and dozens of nonprofits supported by industry funding, spent $740 million to stop laws governing the prescription of opioids. Up from 2016, the pharmaceutical and health products industry spent a record $78 million in 2016.

Because of their lobbying strength in Congress and states, laws and regulations are skewed to benefit the pharmaceutical industry. Medicare, Part D, and the ACA are blocked from negotiating directly with Pharma while insurance companies are too small to take on Pharma and often resort to using Medicare pricing plus a markup. With the appointment of nominee for HHS secretary Alex Azar, the environment for lower pharmaceutical costs by allowing Part D, Medicare, and the ACA to negotiate directly looks dim.

What If They Like a Piece of Legislation?

The pharmaceutical industry can block state legislation by lobbying. If they like a piece of legislation, they can also lobby for it. Fifty-eight pharmaceutical and 26 biotech companies spent $192 million to push the 21st Century Cures Act bill through Congress in 2016. The bill potentially saves drug and device companies $billions in bringing products to market. The Food and Drug Administration will have new authority and tools to speed up approvals and shortcut the process.

– Medical schools, hospitals, and doctors will see increased research dollars coming from a $4.8 billion windfall to the NIH biomedical research organization subject to annual appropriations. “60 schools, 36 hospitals, and several dozen groups representing physician organizations” spent $120 million in lobbying efforts.

– Over two years, $1 billion in state grants will be spent to address Opioid abuse and addiction most of it going to treatment. Mental health and Research got a boost with $millions for old and new programs. Mental health, psychology, and psychiatry groups spent $1.8 million in lobbying disclosures including the 21st Century Cures bill.

– Specialty disease and patient advocacy groups supported the legislation and lobbied Congress. Many of these groups get a portion of their funding from drug and device companies. The bill includes more patient input in the drug development and approval process. The passage of the bill shows off the clout of such groups in their spending of $6.4 million in lobbying.

– More than a dozen computer, software and telecom companies also kicked in for Cures Act lobbying totaling $35 Million in lobbying on the Cures Act as well as other legislation. It will benefit hospitals and groups requiring new technology and programs.

– Funding for the giveaways? The ACA lost $3.5 billion or 30% of its funding taken from its Prevention and Public Health Fund established to promote the prevention of Alzheimer’s disease, hospital acquired infections, chronic illnesses and other ailments.

The bill does nothing to address the rising cost of pharmaceuticals. It promotes unproven and unsafe drug and device approvals which groups such as Public Citizen, Consumer Safety Org., The Associated Press, The Center for Public Integrity, and the National Center for Health Research fought against. The bill leaves the FDA under funded with a miserly boost of $500 million through 2026 to take care of the additional priorities imposed upon the FDA.

And The Politics?

Michigan Representative Fred Upton’s sponsored 21st Century Cures which will save drug and device companies $billions in bringing products to market by short circuiting FDA testing. The Food and Drug Administration will have new authority and tools to bypass studies and speed up approvals. Translated what this means is; the bill allows the FDA to approve new uses, or indications, for existing drugs without rigorous clinical trials and tests now being conducted following proven practices. This would include not taking randomized samples to prove the new drugs are safe and effective. Instead, the FDA could rely on “real world evidence,” which includes observations, safety and side-effect claims, and other data not subject to rigorous analysis. According to Public Citizen’s Michael Carome this a much lower level of evidenced and proven usage.

No friend to the ACA, Michigan Representative Fred Upton sabotaged the ACA Rick Corridor Program and continues to weaken it by taking $3.5 billion or 30 percent of the funding from the Prevention and Public Health Fund to fund the 21st Century Cures Act, a continuation of the Republican attack on the ACA. Since 2000, Representative Fred Upton has received pharmaceutical contributions in excess of $1 million according to Open Secrets Org.

Besides weakening the testing of new pharmaceuticals, the 21st Century Cures does “nothing” to fight the rising cost of pharmaceuticals. Henry Azar took Eli Lilly’s Humalog diabetes drug and increased the pricing of it from $2,657.88 per year to $9,172.80 per year. After acquiring Vimovo, Horizon Pharma increased the price of it from $138 to $2,979 per 60-pill bottle. This is not the end of the story with Horizon. They will sell to customers at a much lower price and bill insurance at the higher price. Turing Pharmaceuticals Martin Shkreli bought the rights to the 62 year old drug Daraprim and immediately increased the price for it from $13.50 to $750 a pill. The same as other drugs, EpiPens will also rise and fall in price at the discretion of its manufacturer with little regard for actual cost.

In the December 15, 2015 JAMA publication, an article (Industry-financed Clinical Trials on the Rise as the Number of NIH-funded Trials Falls) by Stephan Ehrhardt, MD, MPH1; Lawrence J. Appel, MD, MPH2; Curtis L. Meinert, PhD suggests a growing influence of clinical trials conducted by companies with a vested interest in the outcome and a dilution of the impact of government-funded trials. “The number of newly registered trials doubled from 9,321 in 2006 to 18,400 in 2014 (Table 1). The number of industry-funded trials increased by 1965 (43%). Concurrently, the number of NIH-funded trials decreased by 328 (24%).”

While results from NIH-funded clinical trials are more apt to provide the basis for prevention and treatment recommendations; industry-backed studies can produce biased results leading to an increased concern for patient safety. Such was the case with Johnson & Johnson and Bayer’s anticoagulant Xarelto. Data was withheld during its industry-sponsored trial that would have deemed it less safe than traditional warfarin. It was approved without an antidote to bleeding complications in 2011. Thousands of Xarelto lawsuits have been filed against the manufacturer because of the medication’s severe internal bleeding complications.

NIH trials are down by 24% and commercial trials are up 43% many (71%) of which were also foreign funded. Funding for the NIH has fallen 14% since 2006 when adjusted for inflation and will decrease more as adequate funding has not been provided for the 21st Century Cures Act.

In a letter to Democrats Reid and Pelosi from various organizations, it was asked the 21st Century Cure Act be delayed until such time as rising prescription prices are addressed. “ Moving forward with this legislation now would be a missed opportunity to address unaffordable prescription drug prices. There is no justification for moving forward with legislation providing substantial benefits to the drug industry without achieving something in return.”

Again, pharmaceutical company lobbying Congress plus efforts by people such as Michigan’s Representative Fred Upton, has helped the industry reap substantial government sponsored benefits with little reciprocation in lower pricing. Michigan Representative Fred Upton was also the recipient of $597,000 from the Pharmaceutical/Healthcare Industry from 2014 into 2018. The initial bill was started in 2014.

With the 21st Century Cures Act underfunding of the NIH, increased commercial funding of clinical trials, and the relaxing of the need for clinical trials; can the pharmaceutical industry be counted on to be diligent in its testing of new products using “a lower level of evidence than the gold standard, which is randomized controlled trials” (Public Citizen’s Michael Carome)?

It appears the provisions of the 21st Century Cures Act are another stepping stone leading to the erosion of the ability of the FDA to certify the safety of new drugs and their manufacture which began in 1992 with the Prescription Drug User Fee Act (PDUFA). This allowed pharmaceutical companies to pay user fees to the agency in exchange for speedier reviews of their products. The new fees comprise 42% of the FDA’s budget today having grown from 8.5% in 1997. Companies would not be paying these fees if there were not a return for the cost in the market.

One might not think this would increase the danger the safety of new drugs; however, the 10-month time limit assessed does have its negative results. “For every 10 month of reduced review time, there is a correlated 18% increase in serious adverse reactions, 11% increase in hospitalizations, and 7% increase in deaths related to an approved drug.”

How Pharma Avoids Following the Law and the Penalties

The cost of doing business in pharmaceuticals includes paying the fines resulting from getting caught promoting drugs improperly or illegally. There are many prescriptions being written for Opioids for which there are alternate treatment strategies. When challenged, the industry and spokes people are quick to react to any calling for different strategies or limitations of usage.

For example, in 2001 Pfizer’s was ready to put Bextra on the market as a new class of painkillers known as Cox-2 inhibitors, supposedly safer than generic drugs, many times more expensive as ibuprofen, and translating into higher profits. Late in 2001, the FDA placed a qualifier on the use of Bextra for patients with extreme pain. The FDA found it was not safe for people with a risk of heart attacks or strokes and limited the usage of Bextra to people with arthritis and menstrual cramps.

This did not stop Pfizer and its partner Pharmacia from marketing Bextra as safe to use up to a 40 mg dosage. The same as what many healthcare insurance companies do with using doctors for approval of prescription, the companies hired expert doctors. Except these doctors in sales were to call on and convince other doctors (customers) of the safety of Bextra. After all, who argues with a doctor of medicine? Pfizer and its soon to be owned partner pushed the envelope with their claims of safe usage.

In the end what prevented Pfizer from a severe punishment was its size and the many other Pfizer drugs sold to and used by Medicare, Medicaid, and more then likely the VA. “Any company convicted of a major health care fraud is automatically excluded from Medicare and Medicaid. Convicting Pfizer on Bextra would prevent the company from billing federal health programs for any of its products. It would be a corporate death sentence.” The punishment stopped at fines for the illegal selling of a dangerous drug with Pfizer, again a TBTF or Too Big To Ban scenario? To comply with the law; the newly incorporated Pfizer subsidiary Pharmacia & Upjohn Co. Inc., on the same day prosecutors and Pfizer agreed Pharmacia would plead guilty, was banned from billing Medicare or Medicaid. Pfizer continued to do business as normal. Pharmacia & Upjohn Co. Inc. took the fall not once for Pfizer but twice and Pfizer walked away unscathed except for a fine.

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Competition Is for Losers

The Wall St. Journal quoted Peter Thiel’s business plans. It is mostly behind a paywall.

Competition is for Losers

If you want to create and canpture lasting value, look to build a monopoly, writes Peter Thiel

What valuable company is nobody building? This question is harder than it looks, because your company could create a lot of value without becoming very valuable itself. Creating value isn’t enough—you also need to capture some of the value you create.

New Republic points us to the politics of Democrats of monopoly:

What drives monopolization is not business know-how or technological innovation, but public policy—a political environment that permits or even enables an investor like Jeff Bezos to engage in a massive accumulation of economic power. Not that long ago in America, no company as large and destructive as Amazon would have been allowed to exist. Preventing and breaking up such corporate behemoths, in fact, was at the very center of the Democratic Party’s agenda. “Private monopolies are indefensible and intolerable,” the party’s platform declared in 1900. “They are the most efficient means yet devised for appropriating the fruits of industry to the benefit of the few at the expense of the many.”

In the late 1970s, however, the Democrats began to abandon the idea that big is bad. Over the past four decades, the party has stood by as giant supermarket chains replaced local grocery stores and Too Big to Fail banks replaced local lenders. As monopolies broke up unions and drove down wages, Democrats increasingly came to rely on campaign contributions from the very corporations that were consolidating their control over the American economy. The Obama administration, like the Bush administration before it, declined to bring a single major monopolization suit against U.S. companies. Even The Washington Post, that exemplar of political opposition to Donald Trump, is now owned by Jeff Bezos. Dissent, brought to you by monopolists.

But with Republicans in control of all three branches of government, and with the big business ethos espoused by Hillary Clinton in tatters, Democrats may finally be returning to their anti-monopoly roots. Leaders within the party are once again looking to the aggressive antitrust movement launched during the Progressive era and extended through the New Deal, which propelled America into three of its greatest decades of rising prosperity and economic equality. The question now is: Can Democrats find a way to rechannel the popular outrage unleashed by Trump, and to repurpose the party’s traditional opposition to monopoly in the age of Amazon?

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Healthcare Notes

National Health Spending at $3.5 Trillion in 2017, CMS Says:

CMS is reporting healthcare spending was $3.5 trillion in 2017. National healthcare spending grew by 4.6%, up 3 tenths of 1% from 2016. The increase was blamed on increased spending for Medicare and higher premiums for healthcare insurance. The increase in healthcare premiums can be partially attributed to Republicans blocking the Risk Corridor – Reissuances Programs which eliminated competition through withdrawal of insurance companies and bankruptcy of Coops.

Some contributing factors:

• Spending on physician, clinical care increased 5%, to $698 billion. This is a decline from 5.4% in 2016. High deductible plans have more than likely caused this reduction. Price increases for both were 2.4% and expected to increase in 2018.
• Healthcare spending as a portion of GDP is expected to grow from 17.9% to 19.7% between 2018 and 2026. Much of this will be the result of increased prices for medical supplies and services, income growth, and increased enrollment in Medicare.
• The insured portion of the population is expected to drop to 89.3% from 91.1%.
• Private healthcare insurance spending is expected to have grown at 4.7% in 2017 due to higher deductible plans, employer management of their plans, and an aging baby boomer population.
• Hospital Care is expected to grow at 5.5% annually over the decade. It is expected to be at $1.1 trillion in 2017 or a 4.6% increase over 2016 and similar in growth. Private healthcare insurance payments to hospitals is expected to slow by almost 1%.
• Pharmaceutical spending is expected to increase at a rate of 6.6% annually from 2017 to 2026. “Growth in pharmaceuticals is expected to take a bit of a jump soon, from an estimated 2.9% increase in 2017 to a 6.6% increase in 2018.”

Report: Use, Not Price, Drives State Health Costs

“In healthcare, costs of individual services and products make less of a difference in state-level spending than the overall use of those products and services, a new report indicated.” A report of rising costs at the state level being attributed to use as opposed to the rising cost of healthcare products/pharma, hospital/clinal care, and a service for fees cost model impact cost. As I wrote in answer to this perspective:

“If this is leading to people being the cause of higher costs, this is certainly the first time it is being raised in such a manner. One of the much-maligned factors in the ACA was having, as Congress called it, “skin-in-the game” which spells out in the form of higher copays, deductibles, and no discount to charge master and other pricing till the deductible is paid. It is a drag on usage by those with lower income and not qualifying for Medicaid.

Speaking of which (Medicaid) was expanded in 33 states with 18 states abstaining. Dependent upon what time period this study covers, the increased usage and state costs could be the result of such. Maryland is in a unique situation in that it uses an all payer system to control costs. I do not believe the other states intrude upon healthcare costs the same as there.

So what is the direction of this study, lower usage to control cost? It is already being done with the deductibles, copays, and payment schemes. Limit healthcare to those who can pay? If the current administration has its way, the Medicaid experiment will end. I need to see more of the detail. The article cites 3 years of data which would mean from 2014. Are we going to base rising costs upon the implementation of Medicaid and not look at time periods before 2010?

Healthcare costs are still rising at a faster rate than inflation with only the cost of getting an education beating it out from time to time. Pharma is able to raise pricing whenever they choose with little interference other than the media. Services for fees business model still exists. Hospitals and clinics are in a mad dash to consolidate to bargain better. Non-profit hospitals disappeared a long time ago.

Caring for Ms. L. — Overcoming My Fear of Treating Opioid Use Disorder

New England Journal of Medicine had an article on the human side treatment of opioid addiction by a PCP. This story does not end well for the patient. Feeling normal again is what many work towards and never quite get there. Intermingled are the political interests protecting the commercial interests who spend inordinate amounts of money to influence decisions. Pharmaceutical companies have spent $880 million in lobbying all 50 state legislatures and in state campaign contributions to influence politicians to prevent laws restricting Opioid prescriptions. Their spending has outstripped those advocating for greater controls on prescriptions by 200 times giving them greater influence at the state level.

“Ms. L. always showed up 10 minutes early for her appointments, even though I always ran late. Her granddaughter would rest her cheek against Ms. L.’s chest, squishing one eye shut, and scroll through Ms. L.’s phone while they waited. After reviewing her blood sugars, which Ms. L. recorded assiduously in a dog-eared blue diary, we’d talk about smoking cessation. That was a work in progress. ‘There’s just nothing like a cigarette,’ she’d sigh. “Don’t you ever start,” she’d admonish her granddaughter, kissing the top of her head.

One day, I knew something was wrong the moment I opened the door. Ms. L. was alone. Sweat dotted her lip and forehead. She closed her eyes and looked away, and tears fell onto her lap. ‘I need help,’ she whispered, and it all came out: she had taken a few of the oxycodone pills prescribed for her husband after a leg injury, then a few more from a friend. And like a swimmer pulled into the undertow, she was dragged back into the cold, dark brine of addiction. I tried to hide my shock. I’d known she was in recovery from opioid use disorder (OUD), but it had simply never come up. She hadn’t used in decades.

‘No one can know that I relapsed,’ she said. ‘If my kids find out, they won’t let me see my granddaughter.’ She wanted to try buprenorphine and was frustrated to hear that I could not prescribe it. ‘Why not?’ Annoyed, she rocked in her chair. ‘I just want to feel normal again, and I know you. I don’t want to tell anyone else.’”

Just a few short notes on what I have been reading as of late. If you have some time, please click on the links and read the articles. They are not lengthy. More to come as I finish up.

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The Risk of Opioid Addiction

I have been writing on healthcare for a while now and started to look at various topics with regard to pharmaceuticals. In my researching other topics, I found this particular correspondence to the Editor of the New England Journal of Medicine. Illuminating, if one might call it such? “A 1980 Letter on the Risk of Opioid Addiction

The NEJM published 1980 letter:

Addiction Rare in Patients Treated with Narcotics

Recently, we examined our current files to determine the incidence of narcotic addiction in 39,946 hospitalized medical patients who were monitored consecutively. Although there were 11,882 patients who received at least one narcotic preparation, there were only four cases of reasonably well documented addiction in patients who had no history of addiction. The addiction was considered major in only one instance. The drugs implicated were meperidine in two patients, Percodan in one, and hydromorphone in one. We conclude that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction. Jane Porter; Herschel Jick; MD Boston Collaborative Drug Surveillance Program, Boston University Medical Center, Waltham, MA.

In a more recent June 1, 2017 letter to the NEJM editor, the authors dealt with the broad based and undocumented assumption in the 1980 letter of Addiction Rare in Patients Treated with Narcotics and the realization of the addiction and deaths of many people using Opioids. “from 1999 through 2015, more than 183,000 deaths from prescription opioids were reported in the United States and millions of Americans are now addicted to opioids.” Signed by four researchers exploring the reasons why Opioid addiction and deaths have risen, one of the conclusions reached was doctors being told “the risk of addiction was low when opioids were prescribed for chronic pain.” Supplementary Appendix.

From the 2017 correspondence to the Editor entitled; “A 1980 Letter on the Risk of Opioid Addiction,” the authors, by utilized bibliometric analysis of data derived from the number of citations of the 1980 letter from the date of its publication until March 30, 2017. The authors analyzed the relationship between the 1980 letter and it’s conclusion(s) with other document’s conclusions citing the 1980 letter. The analysis can be seen in Figure 1.

608 citations of the 1980 letter were identified (Figure 1) of the index publication. Also noted was a sizable increase in citations after the introduction of OxyContin (a long-acting formulation of oxycodone) in 1995. 439 (72.2%) authors of articles cited the 1980 letter as evidence addiction was rare in patients treated with opioids. 491 (80.8%) authors of articles did not note the patients described in the letter were hospitalized at the time they received the prescription and left readers to assume these were out-patients. As an aside to the citation of the letter, some authors grossly misrepresented the 1980 letter’s conclusion(s) in various comments as shown in Section 3, Supplementary Appendix. In comparison to the 1980 letter citations, the researchers also compared the number of times other letters published in the NEJM were cited: “11 other stand-alone letters taken from the same time period were cited at a median of 11 times.” To be redundant, the 1980 letter was cited 608 times.

The researchers concluded:

a five-sentence letter published in the Journal in 1980 was heavily and uncritically cited as evidence that ‘addiction was rare with long-term opioid therapy.’ Furthermore, they believed the citation pattern contributed to the North American opioid crisis by helping to shape a narrative lessening prescribers’ concerns about the risk of addiction associated with long-term opioid therapy. In 2007, the manufacturer of OxyContin and three senior executives pleaded guilty to federal criminal charges they had misled regulators, doctors, and patients about the risk of addiction associated with the drug. Our findings highlight the potential consequences of inaccurate citation and underscores the need for diligence when citing previously published studies.”

As I have been doing my research on another piece to which this is almost a prelude to it, I have found an overwhelming resistance to any type of control being placed on prescriptions for Opioids of which there are limitations on the number of days a prescription is given for short term pain. The naysayers always go back to the issue of chronic pain.

Whereas one perspective written in the NEJM Reducing the Risks of Relief — The CDC Opioid-Prescribing Guidline comes right out and states; “The few randomized trials to evaluate opioid efficacy for longer than 6 weeks had consistently poor results. In fact, several studies have showed that use of opioids for chronic pain may actually worsen pain and functioning, possibly by potentiating pain perception. A 3-year prospective observational study of more than 69,000 postmenopausal women with recurrent pain conditions showed that patients who had received opioid therapy were less likely to have improvement in pain (odds ratio, 0.42; 95% confidence interval [CI], 0.36 to 0.49) and had worsened function (odds ratio, 1.25; 95% CI, 1.04 to 1.51).”

The resistance to quantity limitations of Opioid prescriptions for non-chronic pain can be felt strongly in both state and federal legislatures by pharmaceutical companies lobbying. In a ten-year period from 2006 to 2015 Pharmaceutical companies have spent $880 million in lobbying all 50 state legislatures and in making campaign contributions in an effort to prevent laws restricting Opioid prescription quantities. In the end, it is just a matter of profits disguised as concern for chronic patient pain care.

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David Dayen reminds us opioid emergency ends in a couple weeks

Lest we forget:

Politico notes today that the 90-day emergency declared actually ends in a couple weeks, and we’re in essentially the same place that we were before the declaration.
Trump has not formally proposed any new resources or spending, typically the starting point for any emergency response. He promised to roll out a “really tough, really big, really great” advertising campaign to spread awareness about addiction, but that has yet to take shape. And key public health and drug posts in the administration remain vacant, so it’s not clear who has the authority to get new programs moving.

A senior White House official said that the president has used the “bully pulpit” to bring urgency to the crisis, and if there’s one thing you want for your cause these days, it’s Donald Trump talking about it. Also it’s the equivalent of thoughts and prayers. By the way, Congress hasn’t really appropriated anything either, so this is a whole-of-government neglect.

Meanwhile, there’s a class divide among those suffering. Those with the means can get better treatment, in New York City and likely nationwide. The poor have to line up for their methadone treatment every day, putting extreme hassle into their lives.

The story is that an epidemic affecting white people would lead to a far more robust response than one that only affects minorities. With the opioid epidemic that’s only partially true.

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The Pro and the Con of Obamacare

I’ve been trying to learn a bit more about PPACA (aka, Obamacare) and its effects. It hasn’t been something that has interested me a great deal until the last week or so, so I am approaching this from a position of ignorance. But I have been reading through as much material as I can find.

Basically, I think the biggest factor in favor of PPACA is the big reduction in the number of uninsured. 14.7% of Americans were uninsured in 2008, the last year before Mr. Obama became President. As shown in the graph below, by 2016, that figure had dropped to 9%. (All figures from table 1.1.b in this CDC report.)

(Click to embiggen)

In terms of actual numbers of people – according table table 1.1.a of the aforementioned report – we went from 43.8 million uninsured people to 28.6 million uninsured people in 2016. This was a huge increase in the number of people with health insurance, and a tremendous benefit for a lot of people.

The biggest factor against PPACA is its cost. According to the Department of Health and Human Services:

Comparing the average premiums found in 2013 MLR data and 2017 CMS MIDAS data shows average exchange premiums were 105% higher in the 39 states using Healthcare.gov in 2017 than average individual market premiums in 2013. Average monthly premiums increased from $232 in 2013 to $476 in 2017, and 62% of those states had 2017 exchange premiums at least double the 2013 average.

As a backdrop to all of this, two additional things are worth noting. The US was already an outlier when it came to healthcare spending as a share of GDP even before the Obamacare provisions kicked in. That despite the fact that many countries that spend a lot less than we do already had something like universal coverage by then.

And speaking of universal coverage and costs, Mr. Obama, in his speech accepting the Democratic nomination for President of the United States in 2008, said this:

Now is the time to finally keep the promise of affordable, accessible health care for every single American. If you have health care, my plan will lower your premiums.

Of course, this didn’t quite happen… more Americans have access to health care, though there are still over 28 million uninsured. And of course, for quite a few (just about all?) of us, this promise of lowered premiums hasn’t happened. Quite the opposite, in fact.

So what is the end state? Why does the system we have fail so many people? How can we make it better?

 

Update…  The graph at the bottom of this article from the Washington Post is quite informative.

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From Employer Coverage to Single Payer Health Insurance

From Employer Coverage to Single Payer Health Insurance

This holiday season I’ve heard several tales of woe from working class acquaintances, mostly self-employed, about Obamacare: how they are just above the subsidy cutoff and would rather pay the fine than buy expensive individual policies, or how they are just below and can’t afford to put in more hours per week. I can understand why there is a lot of disappointment with the Democrats.

So what about single payer? Along with free public higher ed, it’s supposed to be the leitmotif of the resurgence of the left, with even moderate politicians signing on, or claiming to, to save their skins. And I’m all for it too.

But a big political obstacle is widespread employer-based health coverage, a benefit that would disappear under a universal system. As a public employee, I have coverage of this sort myself, and it’s a big part of my overall compensation. How do we fold the millions with adequate-to-good health plans into a new system financed through taxes?

I have an idea. As single payer goes into effect, require every employer to publicly report how much it pays in the form of contributions to employee health insurance, documented by its payment record over the past twelve months. The health care law would then mandate that this sum be returned as added wage payments to employees for some transitional period (such as six months) or the term of the employment contract, whichever is greater. Ideally the law would specify a reasonably progressive apportionment of this payment across the workforce, such as equal lump sums. At the end of the transition, wages increases and decreases would fall under the same employment law rules, such as they are, as before.

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FCC Just Repealed Net Neutrality

The FCC voted 3-2 Thursday to repeal net neutrality rules, ending Obama-era regulations that prohibited Internet providers from blocking or slowing web content.

Whereas all Internet traffic previously shared same ‘lane,’ it can now be split among different lanes with different speeds.

Those differing speeds could hurt telemedicine since it requires a ‘pretty robust connection,’ said Mei Kwong, interim executive director and policy advisor for the Center for Connected Health Policy. ‘The last thing you want is for the interaction to suddenly freeze or the audio to go out or for the picture to be pixelated.'” Modern Healthcare

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