Nailed it!

Three weeks ago I wrote No, the Meuller report ***DID NOT*** “find no collusion!” in which I lambasted and parsed Barr’s conclusory snippet of the Mueller report, to wit, that “[T]he investigation did not establish that members of the Trump Campaign conspired or coordinated with the Russian government in its election interference activities.”

I pointed out that:

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Married male with children, who was asked to write on three different subjects concerning women’s healthcare by the ConsumerSafety.Org . Although I have worked in the healthcare product industry, I am not a doctor.

All three of the healthcare issues I discuss scream for solutions as to what has been done, what should have been done, and how they impact women. I have no doubt if these problems impacted men as much as they do women, a Congress made up mostly of men would have addressed each issue far sooner.

Clinical Trials

Fact: Women make up over half of the U.S. population.

As reported by the GAO, women have been underrepresented in NIH supported clinical research which lead to unidentified differences in treatment results between men and women when incurring a disease. There have been instances of women experiencing different and also adverse effects to medications and treatments than what was experienced by men in NIH Clinical trials. It is thought the NIH’s Inclusion Policy established requirements governing women’s inclusion in its clinical research may have led to this issue.

Some study examples:

The Baltimore Longitudinal Study of Aging started in 1958 did not include women until 1978 in its study even though women lived 6 years longer than men. 1000 men were initially in the study and no women. Another study, the Physicians Health Study concluded in 1989, the taking of low-dose aspirin might lower your risk for heart disease. It included 22,000 men and zero women. A study investigating the possible interactions between the libido-boosting drug Flibanserin (also known as “female Viagra”) and alcohol used a study group of 25 participants which included twenty-three men. It raises the question, why and how would we ever know the impact of drugs on women if only men are used in trials?

Why the Under Representation?

The driving factor for the lack of women in tests is not necessarily driven by bias as much as a lack of knowledge of the biological differences determining how disease symptoms may present in each gender. A broad-based assumption was made of the test findings of men, the results of which could also apply to women, and the testing of men was simpler as men are not subject to the hormonal fluctuations of women. As sound(?) as this reasoning may be in minimizing the number of trials, this appears to be more of a financial decision without considering the biological differences between the genders.

Reports of birth defects from the use of Thalidomide during the 1950s and 60s lead to FDA guidelines excluding potential child bearing women from participation in Phase 1 and 2 clinical studies until reproductive toxicity studies were conducted and evidence of effectiveness and safety was available. The FDA guide lines were misinterpreted and applied to all clinical study phases even though it was not intended to exclude women.

Dangers of Under Representation

Assumptions from an 11 year NIH study on moral development in children using only boys concluded little girls are morally inferior to little boys. Females are simply different and arrive at conclusions different than men and just as moral. Eight of 10 approved drugs were pulled from the market due to health risks for women which were not risky for men. More women than men used four of the drugs and for 4 other drugs women and men used them equally. The differences in men and women between the two sets revealed itself in the later set of 4 with women experiencing serious side effects more often than men. Hence, emphasizing the need to have women equally represented in clinical studies. “Excluding women makes a difference: If women had been included before 1978, the link between osteoporosis-calcium-estrogen and progesterone would have been discovered in time to help their mothers”.

Resolution

In 1993 the Health Revitalization Act was passed which incorporated the use of women and minorities in NIH clinical studies. In 2000, Congress asked the GAO to assess the progress of the NIH. While progress was made to include women and minorities in trials, the GAO recommended the NIH to improve reporting format. Later years the GAO again assessed the NIH recommending the NIH improve the consistency of reporting by sex so as to allow researchers to “identify potentially important sex differences that may ultimately affect patient care.”

Globally the representation in 43% women and 57% men in clinical trial representation. In the US, the representation has improved to 49% women and 51% men. There is still work to be done. Most recently, the 21st Century Cure Act was passed with one of its intents being to move new drugs to market faster through testing in the public sector. “Without detailed clinical trials and studies, there is effectively no way to determine the extent of potential side effects and other issues the current detailed trials and studies provide.” Numbers predicting probability versus clinical trial experience, we will have to see how this plays out.

Essure

In November 2016, the FDA issued a “boxed warning” for the permanent female sterilization device Essure device after reports of it causing perforation, abdominal pain, and serious complications. A “boxed warning” is a type of warning appearing on the package insert for certain prescription drugs or devices. The Food and Drug Administration specifies the warning be formatted with a box or border around the text and is done when there is reasonable evidence of a serious hazard when used. It is the strongest warning the FDA requires.

Essure is a permanent female sterilization device consisting of metal coils which eventually embed into a woman’s fallopian tubes creating scar tissue blocking sperm access to a woman’s eggs. It is reversible only through surgery. In February 2016, the FDA designated Essure to have a “boxed warning” which is meant to alert doctors as to hazards of the device.

In February 2018, a group of women calling themselves the E-Sisters met with former FDA Commissioner Scott Gottlieb. The E-sisters believe Essure has caused themselves and tens of thousands of others health problems, from bleeding, bloating, and pelvic pain to more obscure symptoms such as rashes, tooth loss, joint pain and fatigue associated with an allergic or autoimmune reaction. They brought with them a photo album of other E-Sisters who had suffered because of Essure and also Madris Tomes, a former FDA analyst. Ms. Tomes’s software company tracks adverse medical events reported to the FDA and had logged 26,000 events caused by Essure.

Asking whether a ban might be possible, Commissioner Gottlieb confirmed anything is possible. On March 7, 2018, Gottlieb confirmed Essure would remain on the market. In its history, the FDA has only banned two products.

The original manufacturer Conceptus put Essure through a Level III approval process and presented its data to a FDA advisory committee “touting its near-perfect effectiveness in preventing pregnancy and its high levels of satisfaction among women.” Later studies challenged the initial studies and effectiveness. A Yale study challenged the rigor of the Level III process. a JAMA study reported 5% of all women using these devices required follow up surgery, and a third study claimed women using Essure were 10 times more likely to require surgery.

After November 2017, the U.S. was the only country in the world where Essure was still available after new owners Bayer removed Essure from every other market for “commercial reasons” and not because of safety. Bayer announced in July 2018, it would also remove the device from the US market after December 31st, 2018 due to declining sales.

Maternal Mortality

Healthcare for women and maternal mortality is an important indicator of a nation’s overall quality of healthcare.

Even though maternal mortality worldwide dropped 44% between 1990 and 2015; 830 women die every day from causes related to pregnancy and while giving birth of which much is preventable. 99% of all those maternal deaths occur in developing countries. WHO has launched an initiative to meet the needs of women in developing countries by addressing access to and the quality of reproductive, maternal, and newborn healthcare services. Everyone would agree the effort is necessary in developing countries.

One would think the maternal rate of death in a highly developed nation such as the US would be lower when compared to other and similar nations. Why not? With the advent of the PPACA, many preventative healthcare measures were put in place for women and Medicaid was expanded in many states. US citizens spend far more for healthcare and have greater or similar access to healthcare. And yet every year in the U.S, 700 to 900 women die from pregnancy, or birth-related causes, and an approximate 65,000 almost die due to complications. Contrary to what healthcare should be, the US ranks low in providing maternal healthcare in the developed world.

Even with the PPACA, expanded Medicaid in place; and when compared to their Canadian sisters, American women are three times more likely to die from the start of a pregnancy up till one year after the birth of a child (defined by the Centers for Disease Control). The death rate for American women is 26.4 deaths per 100,000 as opposed to 7.3 deaths per 100,000 in Canada (Chart). The ratio worsens when compared to Scandinavia countries as American women are six times as likely to die as Scandinavian women.

There are two stories, one for economically secure women and another for minority, native American, rural, and lower income women. The statistics worsens for women of color with their being more likely to die in pregnancy or childbirth and are nearly four times more likely to die from pregnancy-related causes than white women. In high-risk pregnancies, African-American women are 5.6 times more likely to die than white women. Amongst women diagnosed with pregnancy-induced hypertension (eclampsia and pre-eclampsia), African-American and Latina women were 9.9 and 7.9 times in danger of dying than white women with the same complications. Native American and Alaskan Native women experience similar discriminatory care. Half of all U.S. births are covered by Medicaid and covers women up to two months past delivery leaving a substantial gap after child birth when other issues can arise.

Barbara Levy, vice president for health policy/advocacy at the American Congress of Obstetricians and Gynecologists; “We worry a lot about vulnerable little babies and we don’t pay enough attention to those things catastrophic for women.”

The emphasis has been on safe baby care and safe birthing which lead to a significant decline in baby mortality. As reported in a Propublica, NPR report, the difference in “maternal mortality numbers contrast sharply with the impressive progress in saving babies’ lives.” Maternal death rates while giving birth and up to one year later has increased by an approximate 10 deaths per 100,000 since 2000 till 2015 or greater than the 9.2 deaths per 100,000 in the U.K, (Chart).

The problems occur before, during, and after delivery.

Mary D’Alton, chair of ob/gyn at Columbia University Medical Center and author of papers on disparities in care for mothers and infants. “The training was quite variable across the U.S., there were some fellows that could finish their maternal-fetal medicine training without ever being in a labor and delivery unit. When I had my own child I realized, ‘Oh my goodness. That was completely insufficient information.'”

And doctors fail to heed the warning signs a women or her symptoms are alerting them too.

Elizabeth Howell, professor of obstetrics and gynecology at the Icahn School of Medicine, Mount Sinai Hospital; “The way that we’ve been trained, we do not give women enough information for them to manage their health postpartum. The focus had always been on babies and not on mothers.”

With 39 weeks of a good pregnancy, the expectant mother went to the hospital to induce labor. Inducing typically ends up with a cesarean delivery. 23 hours later, the mother delivered normally, a healthy baby girl with the only occurrence being sharp pains in the kidney area which was alleviated with more epidural. In 20 hours, a healthy mother before the birth of her daughter died after the birth.

The pain came back 90 minutes after the birth. Upon her doctor husband questioning the ob/gyn, he was told it was acid reflux, which is a common reaction after birthing. The pain increased, her blood pressure spiked at 169/108, and her husband asked the OB whether this could be preeclampsia (which he suspected).

Her blood pressure upon admission was 147/99, she experienced similar readings during labor, and for one period of 8 hours no readings were made. All eyes were on the health of the baby, not on the mother, and what could be coming to pass. For a woman with normal blood pressure such as this young mother, a blood pressure reading of 140/90 could be indicative of preeclampsia.

Her husband reached out to another doctor, he anxiously relayed the symptoms, and she quickly diagnosed what the young mother was suffering from . . . a disorder called HELLP syndrome or Hemolysis, (a breakdown of red blood cells); Elevated Liver enzymes; and Low Platelet count. A disorder if not treated quickly leads to death. The doctor emphasized the need for a quick response to the symptoms told to her.

This is only a brief recital of the tragedy which befell Lauren Bloomstein and her husband Larry. With additional delays in finding a surgeon, Lauren began to experience bleeding in her brain which would lead to paralysis. She knew she was dying before her husband’s eyes. A neurosurgeon was called in to relieve the pressure and stop the bleeding. Since her platelets were low he could not operate, the hospital did not have an adequate supply, and by the time additional supply arrived it was too late. She was brain dead and was allowed to pass on after her daughter was placed next to her one last time.

The warning signs of life-endangering problems were there and were missed (pain in the kidney area) or ignored (abnormal high blood pressure for Lauren), excuses for pain (reflux) were made, and pain killers administered to dull the pain and other symptoms (blood pressure) not explored while she deteriorated in front of her husband who suspected preeclampsia. The missing part of this was the protocol to diagnose early on and prevent Lauren from slipping into late stages of preeclampsia. This is not an isolated incidence as the deaths of women giving birth keep increasing as evidenced in the attached chart.

This is but one story as told by NPR and Propublica. There are many more stories of tragedy which go untold.

by run75441 (Bill H)

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This is a follow up on my post on joy and sorrow. I feel great joy at having found the ultimate abyss of idiocy, but I fear Monday, October 30, 2017 Mysterious Ways

The competition for worst possible argument was provoked by the fact that former White House counsel Don McGahn told Mueller’s team that (sadly) current President Donald Trump twice told him to get Mueller fired and then told him to deny that “fake news” when it was reported.

Rudolf Giuliani attempted to surpass his previous accomplishments in dishonesty and idiocy by quibbling about an immaterial difference in wording

“I would ask, which of the three versions is McGahn standing by?” Giuliani told CNN’s Jake Tapper in response to McGahn’s lawyer’s statement, before listing several versions of the story.

[skip]

For example, while The New York Times used the word “fire” in its January 2018 report on the initial conversations between Trump and McGahn, McGahn himself did not use that word in interviews with Mueller’s team. Yet, Giuliani implied to Tapper that McGahn had used the word, citing the page number of Mueller’s report on which the New York Times article is described and saying: “The first version that he says is, ‘The President told me to fire him because he’s upset about conflicts of interest, and I told him I’d resign.’”

But there’s no such quote credited to McGahn in the redacted Mueller report.

It is impressive idiocy to base one’s case on the inconsistency between saying “Mueller has conflicts and can’t be the Special Counsel.” and “‘The President told me to fire him because he’s upset about conflicts of interest,” but it is truly outstanding idiocy to notice the difference in wording between McGahn’s testimony and a New York Times paraphrase of a leak.

One might expect that Giuliani’s denouncing someone for an immaterial difference between the words Giuliani put in his mouth and the words which actually came out of it would stand as the nadir of dishonest idiocy forever, or at least one day.

I put the following words in Kellyanne Conway’s mouth “hold my beer”.

She argued that we can tell that McGahn committed perjury for no compelling reason because

Don McGahn is an honorable attorney who stayed on the job 18 months after this alleged incident took place, and that if he were being asked to obstruct justice or violate the Constitution, or commit a crime, help to commit a crime by the President of the United States, he wouldn’t have stayed,”

Yes she said we know he is a felon who broke the law for no good reason, because we know he is honorable.

I really can’t even imagine dishonest idiocy which could top that, so I guess I will have to wait at least a day for Trump to outdo his minions.

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Josh Marshall explains it very well here. Mueller definitely did not write that he did not find proof without reasonable doubt that the President is a criminal.

I want to explain it in a way which is not so good, in fact bad, basically malicious, too petty to be evil.

Mueller clearly wrote that he accepted DOJ policy that he could not ask a grand jury to indict Trump *while Trump is President*
He added that he would not write that he would have sought an indictment except for that policy, because it would be unfair to accuse Trump yet not have a trial where Trump could present a defence, confront accusers and subpoena witnesses.

This means he clearly wrote that no matter how strong the evidence, a priori he had decided neither to seek an indictment nor to write that he would have done so except for the policy of not indicting serving presidents.

But Mueller didn’t stop there. He wrote that he wouldn’t write that Trump is clearly guilty of obstruction of justice. Then he noted that there are things he could, in principle, write which happen to be inconsistent with the assertion that Trump is clearly guilty. Finally he noted that he can’t honestly write any of them.

So he wrote to this effect “I won’t say that there is proof beyond reasonable doubt that the President is a criminal. I won’t say anything which contradicts the assertion (which I won’t make) that there is proof beyond doubt that the President is a crminal, because all such statements are false. All statements which contradict the assertion that there is proof beyond reasonable doubt that the President is a criminal are inconsistent with the available evidence. I stress again that I have not written that there is proof beyond reasonable doubt that the President is a criminal. Wink Wink. Nudge.”

Trump better hope that a majority of people can’t handle simple logic. I think he does hope that. I think he is right to hope that. But Mueller really made it very clear that he believes he has found proof beyond reasonable doubt that the President is a criminal and also he isn’t going to write that he found proof beyond reasonable doubt that the President is a criminal.

I’m not a prosecutor and I can write that the Mueller report clearly contains proof beyond reasonable doubt that the President is a criminal.

But Mueller didn’t (quite) write that.

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What would it take to save a scab industry from leaving the market place? The sorcerous of Grand Rapids Betsy DeVos has the answer.

Betsy DeVos’s Department of Education reversed the Obama-era crackdown on vocational and career schools thereby allowing new and inexperienced entrants into the field and alleviating pressure on old participants to have meaningful programs leading to “gainful employment in a recognized position” for which they were trained. Making the words “gainful employment in a recognized position” disappear is what made prior scammers nervous when the government would take action and refunded the fees paid and loans alleviated.

Redundancy alert . . . precisely, the Western Michigan sorceress of charter schools removed the one regulation for “non-profit” and for-profit schools offering programs leading to careers and which allowed the Department of Education to crack down on fraudulent educational programs or programs which did not result in those meaningful words “gainful employment in a recognized occupation.” Ms. DeVos made this one requirement disappear because she did not want to “target schools simply by their tax status” such as “for-profit.” Her assumption was in error as the regulation covered “all” schools whether for-profit or nonprofit and was looking at the offered programs. Our current president even had to ante up when his real estate school did not produce results in gainful employment in a recognized occupation.”

Upon knowing this exclusion by DeVos, I would think even Joe Biden might change his message to Millennials telling them to “tough it out” and he may begin to have some empathy for them after campaigning for Republican Congressional Representative Fred Upton in Betsy’s backyard of Grand Rapids. But then he has been in the pocket of MBNA and Delaware Incorporated banks forever and has made it impossible to discharge student loans through bankruptcy. Maybe???

Now if these six words “gainful employment in a recognized occupation” magically disappeared (psst and they did), what would it take for a career education program to lose its eligibility for federal student aid under DeVos? . . . a for-profit institution could not lose its financial lifeline or federal student aid no matter how poorly it performed its mission as spelled out in a statute to prepare students for “gainful employment in a recognized occupation” resulting from that education as stipulated previously.

One hundred percent of students could be dropped from their career program with all of them deeply in debt, or perhaps no single graduate landing a job in their field of training, and still . . . still the federal government would keep the pipeline of guaranteed federal student loans and Pell Grants flowing in to the school.

With DeVos’s reversal, the NYT surmised: “Executives in the for-profit education industry would be sleeping better, secure in the knowledge that even the worst schools and programs were no longer at risk of “magically” being thrown off the taxpayer-backed gravy train, no matter how epically they failed and robbed their students.” This AB author took liberty and added words to make his point.

Under Obama, “the Job Training industry was on its heels. Under DeVos, they had been given a magical new life, a second chance by the department,” said Eileen Connor, the director of litigation at Harvard Law School’s Project on Predatory Student Lending.

Ms. DeVos, who invested in companies with ties to for-profit colleges before taking office, has made it an agency priority to unfetter schools offering training in professional jobs and trades by eliminating restrictions on them and also nonprofits. She also allowed a growing number of for-profit schools to magically evade those loosened rules by converting to nonprofits.

That is what the Los Angeles Pentecostal megachurch’s affiliate Dream Center wanted to do in 2017 when it asked to buy the remains of Education Management Corporation . . . change it from for-profit to nonprofit and use the profits to fund its other programs. One year after taking over a chain of for-profit schools, dozens of Dream Center schools are near bankruptcy and others have been sold with a hope they can survive.

Collectively Argosy University, South University and the Art Institutes have ~26,000 students in programs resulting in associate degrees in dental hygiene and doctoral programs in law and psychology. Fourteen campuses of mostly Art Institute schools have a new owner after an arranged transfer involving private equity. Another 40 or so others are now under the control of a court-appointed receiver who has accused school officials of trying to keep the doors open by taking millions of dollars earmarked for students to pay operating expenses.

Federal funding for Argosy ceased from the Department of Education when the court-appointed receiver discovered school officials had taken about $13 million owed to students at 22 campuses and used it for payroll expenses, etc. Lauren Jackson seeking a doctorate at Argosy’s Illinois School of Professional Psychology in Chicago did not receive the $10,000 she was due in January. She was paying expenses for herself and her 6-year-old daughter with borrowed money and GoFundMe donations.

26,000 students being defrauded by schools offering programs meant to teach them a skill leading to “gainful employment in a recognized occupation” is only a start to which DeVos has failed to account for in the Department of Education. DeVos does profit by this failure due to her own dabbling in areas feeding off of these failures. There is money to be made in preying on defrauded students, so many of them, and larger than the baby boomer generation. The most tragic consequence of conservatives’ abandonment of federal accountability of career programs is just that and the devastating personal toll it will take on hundreds of thousands of hopelessly indebted students” for whom there is no relief.

Millions in Student Loan Cash Disappears, Tejas Sachdeva, “Tasks”

Inside the Financial Holdings of Billionaire Betsy DeVos

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This tidbit was reported in an October 13, 1989 Los Angeles Times. In a June 21 (1989) legal opinion requested by Atty. Gen. Dick Thornburgh, Assistant Atty. Gen. William P. Barr reversed a ruling dating back to the Carter Administration denying the FBI authority to take unilateral action overseas in what was then referred to as the President’s snatch authority. The earlier Carter ruling had also warned federal agents could face kidnaping charges abroad if they used such tactics.

The ruling was made with regard to bringing Panama’s Noriega to trial for drug- trafficking. Assistant Atty. Gen. William P. Barr refused to discuss the broad new grant of power, the legal grounds used to justify it, or even to acknowledge its existence even though the earlier ruling in 1980 was made public.

When Congress asked to see the full legal opinion; Barr refused and said he would provide an account that “summarizes the principal conclusions.”

Yale law school professor Harold Koh wrote that Barr’s position was “particularly egregious.”

Congress had no appetite for Barr’s stance and issued a subpoena to acquire the full OLC opinion out of the Justice Department.

Koh posits:

“Barr’s continuing refusal to release the 1989 opinion left outsiders with no way to tell whether it rested on factual assumptions that did not apply to the earlier situation, which part of the earlier opinion had not been overruled, or whether the overruling opinion contained nuances, subtleties, or exceptions that Barr’s summary in testimony simply omitted.”

In 1991, Congress obtained a copy of Barr’s 1989 opinion which was later published by the Clinton Administration. What Barr did not disclose and which can be reviewed in Just Security’s Ryan Goodman’s “Barr’s Playbook: He Misled Congress When Omitting Parts of Justice Dep’t Memo in 1989” was:

• The 1989 opinion asserted that the President could violate the United Nations Charter because such actions are “fundamentally political questions.”
• The Presumption of acts of Congress comply with international law.
• A failure to report to Congress the opinion discussed international law on abduction in foreign countries.

While not the principal conclusions of the opinion and whether wrong or right, Barr “represented to Congress in his written and oral testimony that the OLC opinion did not address these legal issues, even though it did.”

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A President Falsely Charging ‘Treason.’

The Constitution: “Treason against the United States, shall consist only in levying war against them, or in adhering to their enemies, giving them aid and comfort.”

Article III; Section 3: Treason against the United States, shall consist only in levying war against them, or in adhering to their enemies, giving them aid and comfort. No person shall be convicted of treason unless on the testimony of two witnesses to the same overt act, or on confession in open court.

The Congress shall have power to declare the punishment of treason, but no attainder of treason shall work corruption of blood, or forfeiture except during the life of the person attainted.

Trump: “I think what the Democrats are doing with the Border is TREASONOUS. Their Open Border mindset is putting our Country at risk. Will not let this happen!”

Conor Friedersdorf, The Atlantic: “’As having an ‘open border mindset’ is not levying war against America nor giving aid and comfort to its enemies, Trump is guilty of levying a false accusation of unsurpassed gravity and additionally guilty of violating his oath to protect and defend Article III, which defines treason as ‘only’ those offenses.’”

I find it difficult to take Trump seriously although I should take him seriously, we all should do so, and we all should work our hardest to make him a private citizen again with the potential of him going to prison afterwards. If two women doing bribes to get their kids into name-brand schools can be charged, then why not Trump for his past frauds? Trump the master dealer maker of fraud and lies. It is not over.

Having Ms. Pelosi as the Speaker of the House was fortuitous for this nation. She knows how to deal with those who have the mindset of a child. Please note the mini-clap of hers after Trump gave his SOTU address to Congress.

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When Jackasses reign.

John Kerry answers a Congressman.

“Kerry delivered his rebuke of the GOP’s inaction on the environment to Rep. James Comer (R-K.Y.). Comer questioned whether there was a reasonable way for the U.S. to afford the ideas entailed in the resolution, which was introduced by Ocasio-Cortez and Sen. Ed Markey (D-Mass.) in February.

Kerry: ‘There are a lot of different proposals about how to proceed. I don’t know that any of them are coming from your party or your side of the aisle.’

Kerry added: (his) ‘focus is on how we’re going to move forward despite varying positions on legislation, adding that regardless of differences among politicians, Ocasio-Cortez has in fact offered more leadership in one day or in one week than President Trump has in his lifetime on the subject.’”

Cincinnati Enquirer

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Just this morning I read this article by The Guardian;

Doctor Who Was Paid by Purdue to Push Opioids to Testify Against Drugmaker

“In a newly released statement to an Ohio court hearing a combined lawsuit of more than 1,600 cases, Doctor Portenoy accuses drugmakers of underplaying the dangers of opioids and of pushing them on patients who did not need them. The doctor said the industry overstated the benefits of narcotics painkillers and ‘understated the risks of opioids, particularly the risk of abuse, addiction and overdose’”.

Apparently Doctor Portenoy was the hired gun for Purdue Pharma and others to promote the use of Opioids. Dr. Portenoy “did a study of only 38 patients and the results were mixed with more than one-third failing to benefit from the drugs. It also lacked the standard scientific rigor of control groups.

But the paper had a significant impact and tapped into a frustration among a group of younger pain doctors at their inability to offer anything more than superficial relief to patients whose lives were dominated by debilitating pain.”

Even though Portenoy’s study lacked the numbers that the Jick and Porter study had in their study, I am sure it had a tremendous impact on subsequent sales. It was a more recent study than the 1980 letter detailing the impact of Opioids in a hospital setting.

In the text of my post on April 7th;

The cause of the Opioid epidemic up till recently can be partially blamed on the misuse of a 1980 Jick and Porter letter to the NEJM. The letter cited the risk of addiction from the “use of Opioids in a hospital setting is rare.” Except when cited by people using this letter 608 times, 80.8% (491) of the citations to promote Opioids failed to mention the use of Opioids was in a hospital setting. Purdue Pharma, other companies, and doctors used this letter to promote the use of Opioids.

In 1996 with the introduction of OxyContin by Purdue Pharma, the use and abuse of the letter almost tripled. If we go back to the charts again, we can see that upon introduction of OxyContin in 1996 a year or so later the death rate per 100,000 doubles and continues to increase yearly. “The aggressive sales pitch led to a spike in prescriptions for OxyContin of which many were for things not requiring a strong painkiller. In 1998, an OxyContin marketing video called ‘I got My life Back,’ targeted doctors. In the promotional, a doctor explains opioid painkillers such as OxyContin as being the best pain medicine available, have few if any side effects, and less than 1% of people using them become addicted.” Increases in drug poisoning deaths involving prescription Opioids increases with 37% of all drug-poisoning deaths in 2013 being attributed to Opioids a 4-fold increase from 1999.

In the 2017 letter to the NEJM, The Jick and Porter Letter is cited in the Supplemental Appendix. The bibliometric analysis of the increased numbers of citations of this letter aligns with the introduction of OxyContin in 1995/96.

“the authors of 439 (72.2%) cited it as evidence that addiction was rare in patients treated with opioids. Of the 608 articles, the authors of 491 articles (80.8%) did not note that the patients who were described in the letter were hospitalized at the time they received the prescription”

The increased numbers of deaths due to Opioid use, as shown in the Joint Commission charts, occurred shortly after the introduction of Oxycontin.

The Guardian article affirms what many of us have been thinking over the last couple of years.

There a pretty detailed discussion of the impact of pharmaceutical companies on the use of Opioids at Naked Capitalism as written by Yves Smith; New York Sues Big Pharma for Opioid Crisis Bill Black, Marc Steiner, Letita James, discuss the study and how Purdue and other Pharma companies influenced the market.

By run75441 (Bill H)

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In writing about the increase in Opioid abuse since 1980 and looking around for additional information for Robert Waldmann, I ran across this information as developed by the US Senate Joint Economic Committee. The committee is majority led by Republicans with Democrats being a part. The committee had added additional yearly data pre-1980, when the Jick and Porter letter had been written to the NEJM on the rarity of addiction from the use of Opioids, to 1968.

The bar chart on the left represents 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 of population from Overdoses solely from Opioids and Overdoses from all drugs during the time period of 1968 to 2015. To be redundant, from both of those charts you can see the increase in the total numbers of deaths by the numbers per 100,000 and the increasing number of deaths per year from 1968 to 2015. During this time period, there were several coincidental things going on which helped to increase the increased deaths. To point out the obvious, drug overdoses really did not start to increase until about 1997.

The Supporting Facts Leading to the Cause

1) This particular bar chart details the citation of a letter sent to the NEJM in 1980 by Doctors Jane Porter and Herschel Jick about a Boston Collaborative Drug Surveillance Program at Boston University Medical Center, Waltham, MA. The verbiage of this letter can be found in the Supplemental Appendix (scroll down). The published letter detail:

“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.”

The letter says, we used Opioids in a “hospital” setting and there was no evidence of addition by patients except for one. From 1980 onward till 2015 the letter was cited 5 to 28 (1996) times per year affirming Opioids do not cause addition. The median number of citations of a letter in the NEJM is 11 times in total. There is nothing to indicate this letter had an impact until about 1997 when the numbers and rates of death due to Opioids doubled (see charts).

The bibliometric analysis of the citations and subsequent chart of the findings related to the Jick and Porter letter can be found in a subsequent 2017 letter to the NEJM entitled “A 1980 Letter on the Risk of Opioid Addiction,” dated June 1, 2017 authored by Doctors Leung, Macdonald, Dhalla, and Juurlink. The appearing and disappearing Supplemental Appendix which has the Jick and Porter Letter (cited) is a part of this article.

2) “In Prescription Painkiller Addiction: A Gateway to Heroin Addiction,” Recall Report organization documents the start of the explosion in opioid use tying it to the introduction of OxyContin by Purdue Pharma in 1995/96. Initially introduced here: Fighting Opioid and Painkiller Addiction Angry Bear September 2018. The increase in the citations of the Jick and Porter letter increases about the same time.

“An early manifestation of the opioid abuse, addiction, and overdose problem occurred largely in rural regions of Kentucky and other parts of Appalachia. OxyContin, a brand name for oxycodone, was introduced by manufacturer Purdue Pharma in 1996 and pushed hard to sell it to doctors. The company sold it as a less-addictive alternative to other painkillers because it was made in a time-release form, meaning users would get a slow onset of the drug, not a hit all at once which is more likely to lead to abuse.”

If a person wanted to abuse OxyContin, they would just grind it up and get the hit all at once.

3) In 2015, the US National Library of Medicine / American Health and Drug Benefits published the “New Perspectives in the Treatment of Opioid-Induced Respiratory Depression.”

“Overall, 44 individuals in the United States die from a prescription opioid overdose daily. In 2013 alone, an alarming 16,235 deaths were attributed to an opioid overdose, accounting for 37% of all drug-poisoning deaths in 2013 and a 4-fold increase from 1999. In addition, nearly 60% of all drug-poisoning deaths in 2013 involved prescription opioids and/or heroin. Furthermore, among individuals aged 25 to 64 years, deaths from a drug overdose—the majority of which were opioid-related—exceeded motor vehicle collisions as the leading cause of accidental death in 2013.”

4) Purdue Pharma pleads guilty in a DOJ lawsuit. In 2007 Purdue Pharma pled guilty in a lawsuit brought against the company by the Department of Justice. The charge was misleading doctors and consumers about how addictive OxyContin was. Purdue ended up paying over $600 million and three executives pled guilty to criminal charges.

5) People switched to Heroin to replace opioids as prescriptions for Opioids are reduced. The deaths from Heroin surpass the deaths by gun homicides. “OxyContin and other prescription opioids caused huge amounts of abuse, addiction, and overdoses. When doctors pulled back on prescriptions, a new epidemic began to arise. In 2015 heroin overdose deaths in the U.S. surpassed the number of deaths by gun homicide for the first time ever. In addiction treatment facilities around the country, heroin addiction is becoming the most common reason to enter treatment, surpassing even alcohol addiction.”

Summation

Robert brings forth a flawed argument made by Tom Nichols or Radio Free Tom; “‘A decaying country mired in poverty and addiction’. I am sorry you seem to have us confused with 1980, but with a positive message like this, you are a shoo-in Mike.” Robert argues back, “But Nichols really demonstrates his contempt for data and expertise by asserting that ‘poverty’ and ‘1980’ go together.” Of course Robert is correct in his facts. There is also no legitimate correlation between Opioids and poverty either. There is a lot of data to support Robert’s contention. The deaths from Opioids were less than one per 100,000 from 1968 until 1997 and from all drugs up till 1987. This can be seen in the charts at the top of the page.

The cause of the Opioid epidemic up till recently can be partially blamed on the misuse of a 1980 Jick and Porter letter to the NEJM. The letter cited the risk of addiction from the “use of Opioids in a hospital setting is rare.” Except when cited by people using this letter 608 times, 80.8% (491) of the citations to promote Opioids failed to mention the use of Opioids was in a hospital setting. Purdue Pharma, other companies, and doctors used this letter to promote the use of Opioids.

In 1996 with the introduction of OxyContin by Purdue Pharma, the use and abuse of the letter almost tripled. If we go back to the charts again, we can see that upon introduction of OxyContin in 1996 a year or so later the death rate per 100,000 doubles and continues to increase yearly. “The aggressive sales pitch led to a spike in prescriptions for OxyContin of which many were for things not requiring a strong painkiller. In 1998, an OxyContin marketing video called ‘I got My life Back,’targeted doctors. In the promotional, a doctor explains opioid painkillers such as OxyContin as being the best pain medicine available, have few if any side effects, and less than 1% of people using them become addicted.” Increases in drug poisoning deaths involving prescription Opioids increases with 37% of all drug-poisoning deaths in 2013 being attributed to Opioids a 4-fold increase from 1999.

The party began to end after Purdue Executives plead guilty in 2007 and Purdue Pharma paid an $800 million penalty. People began to switch to Heroin as the supply of Opioids diminished and prescriptions were for 7 days or less.

In 1980, the country barely knew what Opioids were and the death rate from Opioids was less than 1 per 100,000. Poverty was low then also. The Opioid and Heroin crisis can be traced back to the healthcare industry; its misinformation, lies, and misuse of drugs; and its abuse of people’s trust.

by run75441 (Bill H)

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