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

“Great Drug Companies Out There”

About the time I finished up my post on Biden, I get this article from Dan discussing how Biden is kissing the butts of drug companies to more-than-likely get campaign donations. Everyone else has been concentrating on individual (you know people of lesser means) donations and many candidates have refused to take corporate donations. Biden is not ashamed to take money from corporations. Gee, whata surprise!

Candidate Joe Biden: “By the way, great drug companies out there — except a couple of opioid outfits,” the former vice president told donors at the Dallas home of David Genecov, a craniofacial surgeon.

Biden’s comment came during a discussion of medical research and the cancer “moonshot” initiative he launched during the Obama administration following the death of his son, Beau Biden, in 2015. That effort included his push for companies to collaborate more on research.

While praising the research of pharmaceutical companies, Biden also complained, complained about the high drug prices being experienced by people. Such issues had not stopped him before in supporting Republican candidates for Congress in the last election.

In 2018, Joe Biden came to Michigan’s 6th Congressional District to give a speech to the Economic Club of Southwestern Michigan and pivoted to the topic of Republican Fred Upton at the expense of the Democrat candidate Matt Longjohn. Matt came the closest to beating Upton and Biden gave Fred the boost he needed. Upton had won the district by 20% in previous elections and won it this time by less than 5%.

Biden was paid $200,000 to give a speech to a Republican business crowd supported by Fred Upton in Benton Harbor, Michigan during which he praised GOP Congressman Fred Upton even as Democrats were close to winning Upton’s seat in the gerrymandered Michigan 6th District during the midterms.

It was said Biden came to the 6th District to campaign for Fred Upton because Fred helped to push the 21st Century Cures Act through Congress in support of Biden’s moonshot plan. There is no confirmation of this. The Economic Club of Southwestern Michigan is heavily sponsored by Republican interests and also in one form or another by the Uptons. You would think with Repubs owning the House and the Senate back then, there would be a few issues of making this happen?

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Affordable Housing

The other night, ten Democratic presidential, hopeful, nominees took stage and debated their plans for America’s future. There never was a mention beyond a few garbled words hastily thrown together about an issue which is plaguing many young voters ing to raise families and one which has surfaced in my community, the shortage of affordable homes. Senator Elizabeth Warren knows of the issue as she has discussed it in one of her talks, “The Two Income Family.”

Moderators have bypassed the issue and not asked the question of a candidate’s plan for Affordable Housing which is a growing problem for many people in the US especially young people. In lieu of their not asking, here is a site 2020 Because Housing is Built with Ballots from which you can read each of the candidate’s plans.

The housing crisis has hit urban, suburban, and rural areas with some states being worst(see chart above) than others with regard to supply. Nationally, there is a shortage of 7 million homes affordable and available to the lowest-income renters. Rents have risen faster than renters’ incomes over the last two decades, more people are renting than ever, and the supply of apartments they can afford has lagged. Fewer than four affordable and available rental homes exist for every 10 of the lowest-income renter households nationwide. People of color are disproportionately impacted. Racial segregation persists and concentrated poverty is growing.

Meanwhile, policy makers have disinvested in the nation’s public housing infrastructure, leaving families living in unsafe, unhealthy, and unacceptable conditions. After almost a decade of decline, homelessness is back on the rise, and is in the news in an adversarial manner. The same as with immigrants, people do not want to provide solutions and they want the homeless to disappear. Where they should go has not been determined.

Jumping on this bandwagon pre – election, the one man who has a history of discrimination as learned from a father who was depicted by in song by Woodie Guthrie, President Donald Trump has signaled his intentions to address California’s homeless crisis in a harmful, unjust, and unlawful manner. Involving criminalization, sweeps of unsheltered people living on the streets, they will (potentially?) be moved to federal homeless camps.

Affordable housing and homelessness has been in the news across the country and debate moderators have yet to ask the question of what can be done or what are your solutions to the crisis.

While providing good and affordable healthcare is important; housing, besides a cardboard box, is one of the prerequisites to having good health. One way or another, we will be paying for it.

The Question the Presidential Candidates Don’t Get Asked, City Lab, Diane Yentel

The GAP, A Shortage of Affordable Homes March 2018

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Joe Biden: “How Are We to Pay for Single Payer Healthcare Alias Medicare for All?”

Joe knows the answer to this question and he is baiting the other candidates. Joe has a history of supporting big business interests as witnessed by his aggressive support of the banking industry with bankruptcy laws favoring banking against the needs of citizens and with a special intended harshness when it comes to student loans. Joe has sponsored or cosponsored every bankruptcy bill since 1997. With his question and his healthcare bill, I believe Joe  is courting the healthcare industry and the healthcare insurance industry’s support. Other candidates need to call Joe out on this.

Before moving to Medicare4All or a form of it, we need to attack the costs of healthcare which are rising at a clip greater than inflation.

Much of the payment for improved healthcare will come from negotiating with pharmaceutical companies, reducing the increasing cost of hospital inpatient and outpatient care, rolling back unnecessary pricing increases, reducing costs to 120% of Medicare costs today, etc. There are enough cost targets to attack which should provide a wealth of lower costs and funding for expansion. Healthcare Cost Drivers Pharma, Doctors, and Hospitals

Kocher and Berwick gave an outstanding recital of how we will get from Medicare and Commercial Insurance to just Single Payer Medicare4All. “While Considering Medicare For All: Policies For Making Health Care In The United States Better.” It is unlikely, Congress will move on Medicare4All in the beginning. It will take time. Today’s Medicare is not free from issues.

As the Director of Medicare and Medicaid and upon departing the position, Donald Berwick made this observation of today’s Medicare:

“20 to 30 percent of health spending is ‘waste’ that yields no benefit to patients, and that some of the needless spending is a result of onerous, archaic regulations enforced by Medicare and Medicaid.

He listed five reasons for what he described as the ‘extremely high level of waste.’ They are overtreatment of patients, the failure to coordinate care, the administrative complexity of the health care system, burdensome rules and fraud.

Much is done that does not help patients at all and many physicians know it.”

Within the PPACA, the issues with ACOs must be fixed. The initial PPACA ACO strategy has given hospitals the ability to exploit the market through consolidation, eliminating or minimizing competition in regions, leading to increased pricing, and enabling the employment of specialist doctors, making them “must haves” in insurance networks. As planned, the ACOs should have generated administrative cost synergy and quality benefits instead of enabling ACOs to consolidate and control prices.

Single payer does not use ACOs. In single payer, the government will pay hospitals, healthcare professionals, pharmaceutical and healthcare supply companies. The government will also set the budgets for hospitals and healthcare. Single Payer in Vermont was going to fail and failed due to cost because it used 3 ACOs to manage its plan. Bernie Sanders is also using ACOs in his plan. “Why the Bernie Sanders Bill Is Not Single Payer” The only fear I have of this type of arrangement is the influence of the healthcare industry on those determining pricing and accepting costs. The healthcare industry is attempting to establish a methodology using value brought to the patient clinically and in quality of life with resulting benefits to the health-care system and society also. It is an argument on the issue of the morality of higher prices. Single Payer will have to contend with this as much of the pricing argument is not justified.

The plan should be to gradually move from insurance administered healthcare (what Kocher and Berwick propose) to a single payer system similar to what Sanders proposes but minus ACOs. As I explained, there are enough cost targets to pay for much of the implementation to be derived from reducing costs in the present healthcare system.

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Why Are There More Uninsured Kids?

Ms. Seema Verma is the Administrator of the Centers for Medicare & Medicaid Services. She is the over seer of Trump’s attempts to repeal the ACA. She is smiling now as there has been a reduction in the numbers of people enrolled in public healthcare such as Medicaid and CHIPS. Why did this occur? States having work requirements for Medicaid, adding more red tape to the application process, cutbacks in in outreach and enrollment funds by the Administration, and instill fear, a chilling purposeful effect, to cause immigrant and mixed-status families to not enroll and even withdraw their children from Medicaid/CHIP. The fear of being deported or given a lower status because you are dependent upon Medicaid and other government programs does much to keep them away and in hiding.

Georgetown University Health Policy Institute, Center for Children and Families sorts through the data provided by the Census Bureau in one of its Current Population Surveys. The Bureau actually released a mini-special report focusing on children, “Uninsured Rate for Children Increases To 5.5% in 2018.” The percentage represents a loss of  ~425,000 insured by these programs or 0.6 percentage points decrease from the previous year. A job well done by Administrator Verma.

Joan Alker: What do we know about the kids who have higher uninsured rates?

  • Hispanic children saw a large jump of 1 percentage point from 7.7% to 8.7%. White children were the other racial category to see a statistically significant increase, clear evidence of impact of the Administration’s ongoing campaign of hostility and intimidation directed at immigrant families and the recent issuance of the public charge rule will only make this worse. Many of the children are born in America citizens who have immigrant parents.
  • Young children (age 0-5) saw a large increase as well with their uninsured rate jumping from 4.5% to 5.3%. Without healthcare, a young child’s health care needs are less likely to be met and this is especially troubling when they are in this critical time period when a child’s brain develops rapidly and is building a foundation for future educational and economic success.  Regular visits to a pediatrician for checkups helps children in being healthy and disease and disorders are caught early on in the development.
  • Children in the South are the worst off regionally and saw the highest increases in uninsured jumping from 6.5% as a region to 7.7%. As can be expected, southern states such as Texas, Florida, and Georgia have some of the highest rates of uninsured children in the country already.

More data on the impact of the new polices will be available month end when more American Community Survey looks at the state specific changes for children.

Three main Causes for the increased uninsured:

  •  As I mentioned earlier, mixed families with parents being legal or illegal immigrants and the children citizens. People are afraid of being deported or having their children snatched from them. No prior modern administration has ever separated children from their parents unless their was an overwhelming need to do so such as healthcare.
  •  The administration and Congress’s cuts in outreach and enrollment funding to undermine ACA, one of Barack Obama’s achievements and Trump’s failure to repeal.  Outreach grants for CHIP were delayed significantly by the purposeful congressional funding CHIP till the end of 2017. CHIP was not accepting new enrollments due to a lack of funding and some states cut back. People missed the deadlines as a result. Another purposeful ploy.
  •  Besides ignoring the problems on the increased uninsured rates for children, Seema Verma and CMS are supporting state efforts to tighten up eligibility in CHIP and put in place  stricter verification procedures causing eligible children to lose coverage.

More to Come on What Can be Done.

Why are There More Uninsured Kids and What Can We Do About It?,” Center for Children and Families, Joan Alker, September 12, 2019.

Children’s Public Health Insurance Coverage Lower Than in 2017,” US Census Bureau, Edward R. Berchick and Laryssa Mykyta, September 10, 2019.

Bill H – run75441

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Healthcare News PBM Profits, Expensive Drug(s), Food Protein, and the Opioid Scam

Cigna gets major boost from Express Scripts in Q2,” Robert King, FierceHealthcare, August 1, 2019

And some claim PBMs do not matter in the cost of healthcare? Cigna healthcare insurance generated ~ $38 billion in revenue the second quarter 2019 and a major increase due mostly to a merger with pharmacy benefit manager (PBM) Express Scripts.

According to company financial results released Thursday, Cigna’s pharmacy services business generated $23.5 billion in revenue in the second quarter which represents a massive increase compared to the $1.1 billion generated in the second quarter of 2018. The company reported $1.41 billion in net income.

The major reason for the spike is the gain from the membership and resources achieved from the deal for Express Scripts. Cigna completed the $67 billion merger with the PBM giant late last year.

More Plant-Based Protein in Diet May Add Years,” Nicole Lou, MedPageToday, August 27, 2019

“Significant reductions were found (specifically) in mortalities related to cardiovascular disease. Norie Sawada, MD, PhD, of Japan’s National Cancer Center in Tokyo reported and colleagues reported a positive result in a prospective cohort study of plant protein being substituted for meat protein. It was reported in recent JAMA Internal Medicine study, “Association of Animal and Plant Protein Intake With All-Cause and Cause-Specific Mortality.”

The JAMA study (Association of Animal and Plant Protein Intake With All-Cause and Cause-Specific Mortality) suggests diets with higher plant-based protein intake may contribute to long-term health and longevity. In this cohort study; 70,696 Japanese adults were followed up on for a mean period of 18 years. The outcome associated a higher intake of plant protein resulted in lower total mortality. Moreover, the substitution of plant protein for animal protein, mainly for red or processed meat protein, was associated with lower risk of total, cancer-related, and cardiovascular disease–related mortality.

Furthermore, switching out 3% of daily calories from red meat to plant protein — approximately 260 g of a soy-based food for the average person eating 2,000 calories per day — was linked in statistical models (not through analysis of individuals who actually changed their diets) to reductions in mortality risk.

It is no secret retail drives the meat processing market where large manufacturers and meat packers are big enough to control the market and can drive the pricing down or up per each of cattle. Smaller cattle producers can be driven out of the market as they do not have the massive volume ability to lower their costs of production past a certain point. The criticisms of the plant based protein study I have read are similar to the criticism I have read limiting opioid prescriptions in which they advocate do not limit opioid at all. We could all do with less red meat in our diets which still remains a reality.

The $6 Million Drug Claim, Katie Thomas and Reed Abelson, NYT, August 25, 2019

The link should take you to a different site other than the NYT where you can read the article.

Alexion Pharmaceuticals manufactures Strensiq a drug used to treat a rare bone disease perinatal/infantile and juvenile – onset hypophosphatasia. Adult Dawn Patterson also suffers from the same disease, the excruciating pain from it, which leaves her struggling to work or care for her family. It is a rare disease found more often in children and even rarer in adults.

Dawns husband’s union covers the cost of the drug. The union is suffering sticker shock from the mounting bills for treatments of her and her two of her children who also have the disease. In 2018, the union faced a potential $6 million bill for the Patterson household with an estimated a lifetime cost of $60 million to treat the family over 10 years.

The cost of Strensig as well as other drugs is coming under increased scrutiny and debate over whether any drug should cost $millions of dollars after cost of R&D and start up are recovered. Americans are being priced out of lifesaving treatments as drug companies maximize their profits well beyond start up costs. It has been found, the investment of $1 invested in R&D has provided $14.50 in revenue for cancer drugs (World Health Organization).

As I reported in “Cigna gets major boost from Express Scripts in Q2” (above), Pharmacy Benefit Managers are taking a hefty cut in the process in representing insurance companies with manufacturers. In an earlier post “Can you Patent the Sun,” I had talked more on the topic of costs and company reasoning to set higher prices. Manufacturers are pricing new and older drugs higher and establishing a pseudo morality to maximize their profits.

The US is more vulnerable than is European countries only because Europe sets pricing rather than allow the market to do so.

Opioid Maker Turned Blind Eye to Diversion, Kristina Fiore, MedPage Today, August 28, 2019

In newly unsealed documents, Mallinckrodt employees were worried the existing programs to prevent opioid diversion were not working. One former employee testified about Mallinckrodt not having a computerized system from 2008 to 2009 for tracking unusual orders. Employees had to use their judgment to identify suspicious sales. U.S. Drug Enforcement Agents met with Mallinckrodt PLC and informed the company the agency viewed it “as the kingpin within the prescription drug cartel.”

Superior Court for the State of Alaska Third Judicial District in Anchorage, State of Alaska, Plaintiff vs. Mallinckrodt PLC, Mallinckrodt LLC, and SPECGX LLC.

“In reality, however Mallinckrodt shipped opioids into Alaska without an adequate system in place to prevent diversion of its opioids and to investigate, report, and refuse to fill orders that it knew or should have known were suspicious, breaching both its common law duties and its statutory duties under Alaska law. Despite its legal and ethical duty to report “suspicious orders” of its drugs, and, upon information and belief, ample red flags of potential diversion, Mallinckrodt has never once reported a single prescriber to state law enforcement or the Alaska State Medical Board. Instead, Mallinckrodt incentivized distributors to flood the State with opioids beyond even what the expanded market for chronic pain market could bear.”

Mallinckrodt Was Required to and Failed to Maintain Effective Controls Against Diversion and to Report Suspicious Prescribers. , Page 35, B

There are multiple state lawsuits being filed federal courts nationwide claiming pharmaceutical companies misled people as to the safety of opioid usage.

Opioid settlement would divide money based on local impact, Geoff Mulvihill and Andrew Welsh-Huggins, AP, August 30, 2019

Purdue the maker of OxyContin is negotiating a multi-billion-dollar settlement to resolve a crush of lawsuits over the nation’s opioid crisis. The settlement contains formulas for dividing up the money amongst state and local governments across the country.

The formulas would take into account several factors; opioid distribution in a given jurisdiction, the number of people who misuse opioids, and the number of overdose deaths.

Spelling out the way the settlement is to be split is meant to prevent squabbles over the money avoiding the mistakes experienced with the hundreds of billions of dollars received under the nationwide settlement with Big Tobacco during the 1990s.

September 8; States Attorneys and Purdue have reached an impasse and it is expected Purdue will now file for bankruptcy. It is not clear what the breakdown is over. One of the four states attorneys negotiating with Purdue, Pennsylvania’s Josh Shapiro said Saturday he intends to sue the Sackler family as other states have.

“I think they are a group of sanctimonious billionaires who lied and cheated so they could make a handsome profit. I truly believe that they have blood on their hands.”

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Labor Day

I was doing my usual reading in the internet world and ran across this comment to another commenter who claimed Labor Day is a made up holiday. A lot of history in this reply:

“‘A made-up holiday that never had a great basis for its existence?’

How about the Ludlow Massacre where 57 miners were killed by Rockefeller guards that set fire to miners tents even though they were on private property? Their union leader was held by two militia members and shot in the back by a third. All they wanted was mine safety, their own doctor instead of a company doctor, an eight-hour day, fair pay and a union. Or how about the five workers shot in the back at McCormick Iron Works as they ran from armed guards. They too were just demonstrating for an eight-hour day and better working conditions generally. How about the women who died in a shirt manufacturing factory in New York? They died because they were deliberately locked in a room with no way out when the building caught on fire. How about the workers hung in Chicago after the Haymarket Riot because the Chicago Tribune just about sealed their fate with a horrific attack on them? The Governor of Illinois pardoned others scheduled to be hung because of what he thought was shaky evidence. What about the five marchers shot by police in a Hunger march in Detroit in the middle of the Depression? Or what about the Battle of the Overpass, where UAW organizers were beaten and bloodied by Ford thugs while the Dearborn police stood by and watched. That is except for one time when they stopped the Ford goons from further beating on a lady unionist. The police thought Fords thugs were going to kill the lady. What about Walter Reuther, who was picked up an thrown down again over three flights of stairs, probably avoided being killed because some reporters saw what was happening, picked Reuther up and threw him in their car, then drove away. Then there was the Homestead strike at Carnegie’s steel mill in Pennsylvania—more unionists killed.

How about the practice of blackballing workers if they gave management any grief? It was common practice for owners to put the word out about a worker to other businesses if that worker was deemed a problem or in favor of a union. A blackball meant that a worker would not be hired by other businesses. Indeed, the leader of the Homestead union, nicknamed Lucky by the way, was blackballed and could not find work in this country. He was last seen working in a mine in Mexico.

Closer to home, the accepted narrative is that Henry Ford was a generous man. He wanted his employees to be able to purchase the cars that they were manufacturing. So he started the five dollar day pay rate. Ford deserves his elevated place in history because he was a pioneer in the standardization of parts necessary for mass production. That being said, the five dollar a day came about, not because Ford cared about his employees, but because the annual employee turnover rate was 309%. Work conditions were so bad in Ford’s factory that nobody would stick around. Ford had to replace his entire workforce three times a year. He had to pay five dollars a day to keep the workforce in his shop. Even then Ford’s Sociology Department could enter your home for inspection. If your lifestyle dissatisfied Ford, you did not get five dollars a day.

Let’s touch briefly on the law and government, starting with the Clayton and Sherman Anti-Trust laws. Inspired by the great trust-buster Teddy Roosevelt, those laws were clearly intended to hinder a monopoly condition by business interests, Unfortunately President Grover Cleveland and his Attorney General, Richard Olney, thought differently. When union members went on strike during Cleveland’s administration, they turned the Clayton and Sherman laws on their respective heads, claiming that unions, as monopoly’s, were in restraint of trade, Clearly, that was not the intent of the legislature that created Clayton and Sherman. That’s just one of a ton of examples.

More recently, the Republican legislature and Governor in Michigan passed an anti-union Right to Work bill. Then they attached a financial appropriation to the bill, in affect disallowing Michigan citizens from putting the issue on the ballot through a referendum procedure,

From the Republican’s point of view, that’s probably a good thing as a recent poll shows 64% of Americans favoring unions.

>>> never a great basis for its existence? Aside from the people of color among us, I doubt that any group in this country has so been so hammered and consistently beaten down as America’s workforce. Let’s not forget that today the top 1% are in possession of 40% of the country’s total wealth while wages have been stagnant for forty years. The CEO of Disney makes 1100 times what the average worker makes. If I have read Adam Smith correctly, there is no economic theory that justifies either being the case. Let’s also not forget that our current President has put a corporate lawyer that has spent a lifetime litigating against unions and employees generally at the head of the federal Department of Labor.

Those among us that have grabbed a cup of coffee and a piece of toast on the way to work as employees have earned a special day and much more respect than Matt is able to give us.

I know. I walked on a picket line with one of the brightest, most imaginative, man this country has ever produced — ‘Walter Reuther.'”

Al Churchill’s Comment

Bridge Magazine, “Labor Day has lost some luster, as partisanship pulls us apart,” Phil Power, August 30, 2019

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Purdue Offers Up $10 – 12 Billion to Settle All Lawsuits – MedPage Update

Just revealed:

The opioid/OxyContin maker Purdue and members of the billionaire Sackler family owning the company have offered to settle thousands of lawsuits against the company for $10 to $12 billion. according to people briefed on the offer. More than 2,000 states, cities, and counties across America are pursuing the OxyContin maker over the large bills for cleaning up the opioid crisis — and are deciding whether to accept the offer by Friday. The Financial Times is reporting on this offer from the Sacklers and Purdue.

On August 26, Purdue paid $270 million to Oklahoma and Teva Pharmaceuticals paid $75 million also to Oklahoma.

From the Financial Times: “Purdue said it believes a ‘constructive global resolution is the best way forward’ and is working with state attorneys-general and other plaintiffs to achieve it. While Purdue Pharma is prepared to defend itself vigorously in the opioid litigation, the company has made clear that it sees little good coming from years of wasteful litigation and appeals”.

For all the harm done to this nation due to purposeful deceit and lies on the use of opioids claiming it was not addictive, someone needs to go to prison from the Sackler family.

Purdue Exposed

Medpage Today, Kristina Fiore, August 28,2019

I suspect with the new information being available, Purdue finally threw in the towel and offered a settlement. I also suspect this will impact other companies decisions to appeal as J & J is doing.

STAT News Wins Legal Fight Over Purdue Documents

A trove of documents detailing Purdue Pharma’s role in the opioid epidemic will be made public, STAT News reported, as the Kentucky Supreme Court denied the company’s request to review lower courts’ decisions to release them.

STAT waged a 3.5-year legal battle to make those records public. While some remain under seal, the outlet posted a sought-after video deposition of Richard Sackler. It had obtained a transcript of that deposition in February, which gained further attention when comedian John Oliver hired famous actors including Bryan Cranston and Michael Keaton to re-enact it.

The documents promise new information on how Purdue promoted its oxycodone product OxyContin and what, exactly, its executives knew about its risk of addiction. Among those documents are depositions of other Purdue executives; physician testimony; emails and memos about marketing strategies; internal reports on clinical trials; and communications about earlier legal cases.

All of the documents were part of Kentucky’s lawsuit against Purdue over its alleged illegal marketing of OxyContin. That suit was settled in 2015, with Purdue shelling out $24 million.

Purdue may soon be paying a far higher bill, with media including NBC News reporting that the company has pitched a $10 to $12-billion settlement in the consolidated cases set to go to trial before a federal judge in Ohio in October.

This does not bode well for Purdue, its settlement, or threat of years of litigation. The smoking gun was always there and pieces of it can be found in previous posts of mine. Relating the US Senate Joint Committee numbers to when Oxycontin was introduced after 1995 and the incremental increase in deaths from opioids, the use of a part of the Porter and Jink letter to the NEJM which said opioids were not addictive “minus the part where it said when used in a hospital setting,” the abuse of the Porter and Jink letter in the number of citations, the millions spent in lobbying state legislatures to block new laws, etc.

John Oliver uses Keaton and Cranston to portray Richard Sackler in this 20 minute Clip. It is worth watching. “the launch (Oxycontin) would be followed by a blizzard of prescriptions that will bury the competition. The blizzard will be so deep, dense, and white,.”

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J & J and It’s Subsidiary Janssen’s Actions “Created a Public Nuisance”

“The court found that Johnson & Johnson’s actions had created a “public nuisance,” which Oklahoma law defines to mean an act (or failure to act) that ‘annoys, injures or endangers’ the health and safety of an ‘entire community.’

In a 42-page opinion, Oklahoma State Judge Thad Balkman details how Johnson & Johnson’s sales and marketing assured doctors the appearance of addiction in patients due to the use of J & J opioid products was actually evidence of ‘under-treated pain’ and required the prescribing of more opioids. Sales representatives used these aggressive marketing tactics to target prescription-happy doctors referred to as ‘Key Customers’ in internal correspondence.”

I can not help but feel there comes a time when one must look at the continuing misuse of opioids under a doctor’s care and wonder what the doctors were thinking.

Multiple times I have written on the deadliness of opioids. To market and promote the use of opioids, the pharmaceutical industry deliberately took one sentence of a letter written by Doctors Porter and Jink to the NEJM in 1980 and claimed the use of opioids as safe in all environments and not mentioning Porters and Jink’s study was done in a hospital setting.

Addition Rare in Patients Treated with Narcotics, NEJM 1980: “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.” Boston Collaborative Surveillance Drug Program, Boston University Medical Center, Waltham NA 02154

From 1980 till 2015 the letter was cited 491 of 608 times affirming the use of opioids does not cause addiction. There was a significant increase in citation after the introduction of OxyContin in 1995. The “median number” of citations of a NEJM letter was 11 times in total. The citation of one sentence in whole or partially was many times more.

In Prescription Painkiller Addiction: A Gateway to Heroin Addiction,” Recall Report documents the start of the explosion in opioid use tying it to the introduction of OxyContin by Purdue Pharma in 1995/96.

The United States Congress Joint Economic Committee provides two charts detailing the total “number” of deaths per year from overdoses solely from opioids and Overdoses from all drugs during the time period of 1968 to 2015. The bar chart on the right represents the “numbers” of deaths per 100,000 (rate) of population from Overdoses solely from opioids and Overdoses from all drugs during the time period of 1968 to 2015. There has been arguments made there is no discernable evidence showing the impact of prescription opioids on the numbers of deaths. These two charts certainly points in a direction of the impact of prescribed opioids on the death rate.

Up till seeing the Joint Committee data, I had not seen earlier data. In these charts can be seen the additional yearly data predating 1980 when the Jick and Porter letter had been written to the NEJM going back as 1968. This data is important to see the magnitude of the introduction of prescribed opioids such as Oxycontin and the influence of them and the pharmaceutical industry on the usage of opioids said to be a safe drug to use outside of supervision.

State Judge Thad Balkman’s verdict will be appealed in higher state courts. If upheld, it will go to the federal courts. J & J is not a company without financial resource and they will contest this verdict as far as they can take it. The importance of the verdict is in holding a company, a citizen amongst us as declared by SCOTUS responsible for the abuse of opioids as shown in the numbers presented in this post, in earlier posts, and in the related documentation presented in all of my posts on opioids.

Reference Data

What the Oklahoma Johnson & Johnson Verdict Means for the Future of Opioid Litigation, Jay Willis, Microsoft News, August 27, 2019

Opioid Use since 1968 and Why It’s Abuse Increased, run75441 (Bill H), April 7, 2019

The Rise in Opioid Overdose Deaths, US Senate Joint Economic Committee, August 01 2017

Prescription Painkiller Addiction: A Gateway to Heroin Addiction, Recall Report

run75441 (Bill H)

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“pruning the tree when spring starts”

End of month July and Pfizer is spinning off Upjohn to generic drug/device company Mylan NV. Pfizer bought 57% of the unnamed (mid – 2020) new company. This move comes under Pfizer CEO Albert Bourla who took over the reins from Ian Read in January, 2019. Bourla has been with Pfizer for 25 years. Before becoming the CEO, Bourla was the Chief Operating Officer (COO) overseeing the company’s commercial strategy, manufacturing, and global product development functions.

CEO Bourla has been making strategic moves following what he has called a “pruning the tree when spring starts and Pfizer is in the spring of high growth” strategy. What caught my eye is this one comment in the Wall Street Journal about remaking Pfizer into a company focused on patent-protected prescription medicines with the potential for significant sales growth from a more diversified but slower-growing player. To me, this translate into a; “hey the Mylan EpiPen strategy worked, lets do the same with other products” strategy.

To date, he has overseen a restructuring at the company and made smaller deals to boost Pfizer’s pipeline of cancer and other drugs under development. Still not the biggest deal which would make Pfizer a giant. He has been guiding the combining of a division selling Advil, vitamins, bathroom found meds with GlaxoSmithKline PLC’s own consumer-health business to be spun off in a joint venture. Nothing earth-shattering there.

CEO Bourla focus for Pfizer on higher profit, exclusive, prescription drugs while moving the rest of its lower profit operations into other ventures. Off-patent drugs such as Lipitor and Viagra having lower profit margins would be targeted for joint ventures and Pfizer would still retain sizeable amounts of cash flow from these drugs to fund R&D. Pfizer is shifting the declining brands to Upjohn. The intent is to consolidate this business with Upjohn and merge Upjohn with the EpiPen company Mylan and rename the two.

The new Pittsburgh – based unnamed company is expected to be among the world’s largest sellers of generic and off-patent medicines with more than $19 billion in yearly sales. Pfizer Shareholders will own 57% of the new company and Mylan shareholders would the rest. Pfizer would be paid $12 billion raised from new debt acquired from the joint venture. Upjohn would return to the US from its corporate base in Shanghai, a reversal of its earlier inversion.

To me, this is a strategic move along the lines of Pfizer selling off the marketing of EpiPen to Mylan and keeping the manufacturing of it. Pfizer owned Meridian Medical Technologies manufactured EpiPen for Mylan and it will now be a part of the sale to Mylan. EpiPen was a huge success story for Mylan. A quadrant strategy of milking of a cash cow to fund new ventures.

Including EpiPen, “Mylan’s operating profit for its Specialty segment grew from about 35% in 2012 to roughly 60% in the second quarter of 2016.” Most of this can be traced back to the change in design of the EpiPen (cap) , exclusivity of it due to design changes which was covered by patents, and the rejection of Teva’s generic by the FDA due to a difference in application.

Add to this strategy story, Eli Lilly’s Alex Azar’s success profiteering off of the decades old diabetes drug Humalog and one can begin is imagine what the new “unnamed” company’s role will be under CEO Albert Bourla’s direction . . . more of the same.

In its analysis, World Health Organization determined the expenditure of one dollar in R&D being covered by $14.50 profit for cancer pharmaceuticals or more than enough to recoup expenditures for R&D and provide a healthy return for investors. The generics Upjohn will acquire have more than paid back the costs of R&D and are more than likely to be in a decline in producing profits. The question then becomes how to enhance the return on these generics.

Mylan changed Pfizer’s EpiPen design to achieve patented exclusivity. Teva could not duplicate it as a generic because patients could not use the Mylan instructions in applying the Teva generic. According to FDA’a rules, the Teva product could not be cast as a generic for the Mylan EpiPen in the marketplace as it could “not” be used in the same manner..

EIi Lilly’s Humalog, same formulation as what was made decades ago. The list price for one vial of Humalog has nearly tripled over the last decade. No new and improved or patent changes. Lilly appears to be taking increased profits from the price changes and passing on a larger slice to Pharmaceutical Benefit Managers to gain preference by healthcare insurance plans represented by the PBMs.

The same at the other diabetes med manufacturers Sanofi and Novo. Sanofi, a diabetes drug manufacturer and competitor to Eli Lilly gave insurers and pharmacy benefit managers rebates totaling more than half of its gross sales in the U.S. last year, resulting in net price declines across its portfolio despite list price hikes taken on dozens of its prescription products.

What is occurring is “shadow pricing” increases where one company raises pricing and the others follow.

A lawsuit filed in 2017 alleged three companies (Eli Lilly, Novo Nordisk, and Sanofi) intentionally raised the list prices on their drugs to gain favorable treatment from pharmacy benefit managers, who work with health insurers and drug makers and help decide how a drug will be covered on a list of approved drugs. Insurance companies do not pay manufacturer list pricing. The PBMs negotiate a rebate to the insurance companies from which they take a portion of it for themselves. The insured gets the net price after Rebates are paid to insurance company minus the PBM bonus for negotiated price.

It is in this circus of net profits after rebates and bonuses, I believe the Upjohn/Mylan “nameless” new company battle will be fought to increase Pfizer’s profit. This is not like the EpiPen medical device where a change in design of the pen can be made and a new patent secured. Some drugs may be changed which would result in a new patent. I suspect much of Upjohn/Mylan product profit improvement will be fought by getting preference from Pharmacy Benefit Managers.

CEO Albert Bourla will be watching the new company to see how successful they are in creating preference with PBMs and the resulting profit.

Why are our drugs so Costly? Watch the YouTube Presentation to Understand why Drugs are so Expensive to You.

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Denmark Offers to Buy the US

Andy Borowitz, The Borowitz Report, COPENHAGEN: After rebuffing Donald J. Trump’s hypothetical proposal to purchase Greenland, the government of Denmark has announced that it would be interested in buying the United States instead.

“As we have stated, Greenland is not for sale,” a spokesperson for the Danish government said on Friday. “We have noted, however, that during the Trump regime pretty much everything in the United States, including its government, has most definitely been for sale.”

“Denmark would be interested in purchasing the United States in its entirety, with the exception of its government,” the spokesperson added.

A key provision of the purchase offer, the spokesperson said, would be the relocation of Donald Trump to another country “to be determined,” with Russia and North Korea cited as possible destinations.

If Denmark’s bid for the United States is accepted, the Scandinavian nation has ambitious plans for its new acquisition. “We believe that, by giving the U.S. an educational system and national health care, it could be transformed from a vast land mass into a great nation,” the spokesperson said.

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