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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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Confessions of a Late to the Party Russiagate Non-Skeptic

I don’t think this is worth your time, but when I post only at rjwaldmann.blogspot.com Dan pulls the post over here so I might as well.

Like many many (too many) people I am irritated by this article by Blake Hounshell.

Hounshell claims to have “doubts about whether Donald Trump colluded with Russia” I have a couple of questions. One is: Which word in “Trump colluded with Russia” didn’t you understand ? The answer is “colluded” which is repeatedly redefined in the article so it can dodge a hail of facts and remain unproven. The other (which I actually asked him) is:if in 2014, I had described the Trump tower meeting & preceeding e-mails (without inventing names) and asked “would you call this ‘collusion'” what would you say ?

There would be a follow up question if his answer were “no”: OK now describe an imaginary scenario which you would call collusion.

I think it is not possible for a mainstream journalist to note that we know that Trump jr colluded with Russians. The rules of journalism can’t all be followed in the present case in which the President regularly asserts things which are demonstrably false. There has to be a debate about whether collusion will be detected, even though it has been detected.

I think Hounshell’s interest is in whether there is a story out there. The fact that the story has already been told right in here where we all heard it is irrelevant. The question is whether there is a big scoop to be made. Another important question (which Hounshell barely addresses) is whether the collusion constitutes the crime of conspiracy and whether the colluders will be prosecuted.

I decided to write this post to point out an amusing contradiction in the article. Hounshell argues that, if there had been collusion, Trump would have openly blabbed about it since he has no self control & also that Donald Trump’s open collusion on TV isn’t collusion because it was open blabbing. I quote

Then there’s the Trump factor to consider. Here’s a man who seems to share every thought that enters his head, almost as soon as he enters it. He loves nothing more than to brag about himself, and he’s proven remarkably indiscreet in the phone calls he makes with “friends” during his Executive Time—friends who promptly share the contents of those conversations with D.C. reporters. If Trump had cooked up a scheme to provide some favor to Putin in exchange for his election, wouldn’t he be tempted to boast about it to someone?

[Biiig skip]

There is, of course, plenty of public evidence that Trump was all too happy to collude with Putin. “Russia, if you’re listening, I hope you’re able to find the 30,000 emails that are missing,” springs to mind …

The fact (noted six (6) paragraphs later) burns Hounshell’s argument to the ground, scatters its ashes to the nameless howling winds and sows salt where once it stood.

(I am quoting Noah Smith quoting someone else).

Hounshell’s argument rests on Catch 22 — Trump can’t collude without discussing the collusion in public and public requests can’t be collusion themselves or correspond to private collusion because they are public.

It may be true that Trump couldn’t conspire with Russia without talking about it in public, but it is certainly true that he talked about it in public. Again the question, can Hounshell imagine a scenario less devastating for his argument. Hmm well collusion typically involves a quid pro quo not just a request. Lets run the tape

“Russia, if you’re listening, I hope you’re able to find the 30,000 emails that are missing. I think you will probably be rewarded mightily by our press.” He said this after Papadopoulos was informed by the Russians that they possessed Clinton-related emails.

Hmm “rewarded mightily”. Note the “by our press” makes no sense. Respectable newspapers don’t pay for stories and disreputable ones don’t have access to sums which would seem mighty to the Russian government. I think the “by our press” locked the door after the horse had escaped the horses mouth.

So what’s going on ?
1) Maybe Hounshell is Fukayaming
2) Someone suspects he is stuck in the pose of a cynical sophisticate who has seen worse before and is amused by how excited the non-cognoscenti are.
3) He is thinking of whether a journalist should invest in an effort to find another smoking gun. It would be very hard to top the two which have been smoking away for months. So there is no professional gain there — only crimes against democracy.

I think point 3 is the important one. There will be no dramatic proof that Trump is a crook for the same reason that there will be no dramatic proof that water is wet.

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Mueller et al Declared that there Was Collusion

The post entitled “Trump’s Claim Mueller Found ‘NO COLLUSION’ Is Literal Nonsense” is not up to Jon Chait’s usual standard. Trump’s claim is, of course, nonsense. Chait accurately described Trump’s typical pathetic rhetorical trick “One of President Trump’s favorite methods to defend his innocence in the Russia investigation is to claim that any piece of evidence that does not explicitly assert his guilt is in fact evidence of his innocence.” and added some high quality snark “It is exactly like saying Trump was cleared by the Warren Commission because the Warren Commission report makes no conclusion about Trump and Russia.” However, he misread the indictment.

Chait (and many many others) concedes that the indictment didn’t declare that collusion has been detected “this particular indictment probably has nothing to do with collusion. ” In fact the indictment declared that collusion has been detected. it didn’t name all of the conspirators, but the grand jury did definitely claim to know of conspirators who were not named in the indictment.

I quote (with a pdf warning and my emphasis)

From in or around 2014 to the present, Defendants knowingly and intentionally conspired with each other (and with persons known and unknown to the Grand Jury) to defraud the United States by impairing, obstructing, and defeating the lawful functions of the government through fraud and deceit for the purpose of interfering with the U.S. political and electoral processes, including the presidential election of 2016.

The indictment explicitly states that only some of the “known” conspirators have been indicted. It doesn’t say whether any of the unindicted conspirators worked for the Trump campaign, but it definitely also doesn’t say that no crimes Trump campaign workers have been detected in the investigation into internet trolling (let alone the broader investigation).

The indictment explicitly states that there are known unindicted co-conspirators. It does not address the question of whether one is, say, named Donald Trump, even within the narrow limits of the investigation of “INTERNET RESEARCH AGENCY LLC” and its employees.

I mean which word in “conspired with … persons known … to the grand jury” didn’t he understand ?

update: This post by Marcy Wheeler is incomparably better than my little post. Read it.

One point from Wheeler– a US citizen conspirator who was not indicted has been named. Richard Pinedo was not indcted because he pleaeded guilty on February 7th. The indictment can’t be construed as stating that the Grand Jury does not have probable cause to believe Americans were wittingly involved in the conspiracy. At least one definitely is known. He wasn’t indicted because he confessed.

Wheeler wrote

In the wake of that indictment, the court unsealed a February 7 plea agreement with Californian Richard Pinedo, for identity theft (basically, selling bank account numbers; the information doesn’t identify the users who purchased the bank account numbers as IRA personnel who used them to set up “American” identities, but that is clearly what happened).

update 2: I have a thought. Wheeler wrote

Plus, Mueller likely obtained cooperation from one IRA employee, the unnamed person who traveled to Atlanta in November 2014 for reconnaissance. Had that person not cooperated, he or she would have been named in the indictment.

This is probably true, but I think that I have thought of another possibility. It is possible that Atlanta traveller wasn’t indicted because he or she didn’t commit a crime. Two women were indicted for lying on their visa applications saying they were in the USA for tourism not reconnaissance. But reconnaissance isn’t a crime. It sometimes called journalism and sometimes called market research. If Atlanta traveller claimed to be a journalist, he or she is in the clear. The US government can’t decide who is and who isn’t a real journalist (just as it can’t decide who is a real clergyperson) because everyone has a first amendment right to claim to be a journalist (the first amendment doesn’t say anything about citizenship — foreigners have free press rights too). IRA wasn’t seeking classified information — they wanted to know what Americans were saying about the election. The reconnaissance was journalism which is legal except for people who lied claiming to be tourists.

So maybe someone did something totally legal, can’t be indicted and wasn’t named because he or she has a right to some privacy while observing us.

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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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Watch Out for Charlie Kirk’s Treacle Tart

“There’s many a fly got stuck in there.”

Who is Charlie Kirk? He is the 24-year old executive director and founder of Turning Point USA. Jane Meyer profiled the organization in the New Yorker in December:

Based outside of Chicago, Turning Point’s aim is to foment a political revolution on America’s college campuses, in part by funneling money into student government elections across the country to elect right-leaning candidates. But it is secretive about its funding and its donors, raising the prospect that “dark money” may now be shaping not just state and federal races but ones on campus.

A couple of weeks ago in The Baffler, Maximillian Alvarez described the tactics employed by TPUSA to harass and silence opposition to their “free market” totalitarianism. If you like Tomi Lahren, Sebastian Gorka, Donald Trump Jr. and Sean Hannity, you’ll love Charlie Kirk.

Charlie Kirk is a Charlatan.

Last Friday, the Sandwichman posted Is the “Invisible Hand” a lump of labor? to EconoSpeak and Angry Bear. It received a little over 300 views on EconoSpeak and a total of three comments on both blogs. Charlie Kirk’s twitter video on the “socialist myth of the ‘fixed pie'” was tweeted three days earlier. It has so far received 3,300 “likes” and 1,688 comments.

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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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GOP’s “I See “Secret Societies” Meme

The line in the movie The Sixth Sense, “I see dead people. They don’t know they’re dead.” Repubs; “I see Secret Societies, others do not know they exist. They are everywhere.”

Daily Beast’s Rick Wilson; “The story was falling apart even before the Moron Caucus beclowned themselves with the ‘Secret Society’ meme (my addition), because the memo obviously hadn’t done enough to reduce the Republicans in stature and seriousness. Seizing on a single, obviously joking text message, Sen. Ron Johnson took to the microphones to describe the FBI’s alleged ‘Secret Society’ as if he had watched Eyes Wide Shut enough times to memorize it. Fidelio, Ron. Fidelio.

When confronted with the risible absurdity of his claim, Johnson said ‘informants’ had told them about the dark, satanic orgies of the FBI. Within hours, he denied all of it in an embarrassingly clumsy walk back. From the Trump-right obsession with ‘Q-Anon’ as a source of Deep State gibberish to the uncritical acceptance of even the most outrageously absurd rumors, the GOP is becoming defined as a party of conspiracy. It’s is a bad look for a governing party, and it’s getting worse by the day.”

This is what the Koch Bros poured $millions into Wisconsin in support of Ron Johnson and Wisconsin Republicans, a cultural divide to hide behind and defend one’s self no matter how ridiculous. Hopefully, the adults in the room can maintain . . .

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Glenn Greenwald & the Nunes memo

I’m not sure this is of general interest, but I would like to argue (again) with Glenn Greenwald. In this tweet, he asks an interesting and important question

The FBI, and many Democrats, insisted vehemently that release of the Nunes Memo would endanger national security. Now that we’ve all read it, is there anyone who believes that this argument was even remotely true or honest?

Yes. This has been another episode of simple answers to simple questions. Now I will bore you by explaining at length.

1) One can’t conclude that something wasn’t endangered because, it the end, it wasn’t harmed. It is reckless to drive 150 mph drunk even if some people have done so and arrived alive. I don’t recall anyone saying that releasing the memo would certainly harm national security.

2) Importantly, the expressions of alarm (including the DOJ not FBI use of “extremely reckless”) came from people who had not seen the memo, who had requested a chance to examine it and whose requests had been denied by the committee. They didn’t know what was in the memo, but they knew it had been written by people who had access to classified information, that they didn’t know what was in the memo, and that it was proposed that it be released so everyone knew as soon as they did.

The argument that this violates normal procedures which are required to protect national security is clearly conventional — almost so conventional that it goes without saying. The procedures are followed not because every deviation has catastrophic consequences. That’t the way standard procedures are.

I don’t recall all the alarmed statements by Democrats, but many were made by Senators and such who had not been allowed to see the memo.

3) Finally releasing the memo clearly harmed US National Security. I get the impression that almost everyone but I has the impression that the memo didn’t contain information which was supposed to be kept secret (according to normal rules which are enforced on people who aren’t President or the majority of a House committee by the threat of prison).

There are two data in the memo which had been secret and which were kept secret for excellent reasons
a) October 21 2016 — the date of the application for a FISA warrant to surveil Carter Page. This was not a request for a renewal. Now, but not last week, I can infer that Page was not under FISA surveilance say in September 2016. I didn’t know that before. If I had conspired with Page on the phone during September 2016, was asked about it by the FBI and had to decide whether to lie to them, this information would be very useful to me. it is discussed only as proof that the fall 2016 FISA surveillance of Page was *not* surveillance of the Trump-Pence 2016 campaign, since he had severed all formal links with the campaign in September. But it would also be useful if there were someone who really wants to know that the FBI knows about his or her communications with Carter Page before October 21 2016.

b) The warrant was renewed at least three times. This is discussed becuase one of the requests for renewal was approved by Rod Rosenstein and because the fact that four requests were approved is strong evidence that the surveillance revealed Page’s participation in foreign intelligence efforts. But the information would be very useful to me if I had conspired on the phone with Page in December 2016. I would know that they know about it, so I would risk prison were I to lie and deny the activity.

In spy vs spy intelligence and counter-intelligence hiding all sorts of information from the other side is key. Who is being wiretapped is a closely held secret for obvious reasons. My point is that there are similar reasons to hide who has been wiretapped (including Page as was known before the memo was released) and when they were wiretapped, If one is under investigation, it very important to know what the investigators know. If one is not supposed to obstruct justice, one should not make that information public in the name of transparency.

OK so what is going on ? I think that Greenwald has become a knee jerk critique of Democrats. Also he has long had a very sincere extremely negative view of the FBI. I think his reflexive opposition to state surveillance has caused him to automatically reject arguments based on the idea that FBI investigations are sometimes in some ways socially useful.

He isn’t a consistent anarchist, but he seems to automatically oppose state power. Thus he seems to actually support complete trasnparency in investigations. This would make wire taps worthless. I think Greenwald automatically opposes them.

On the other hand, he is a brilliant lawyer. He should understand why the facts revealed in the memo had been kept secret. Almost everyone agrees with him that no secrets were revealed by the memo. I’d guess most people just don’t understand the issue. But I guess that he understands it and is so opposed to serveillance of any kind that he genuinely can’t see how anyone would see any disadvantage in hampering it.

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Distractions, Distractions

Distractions,  Distractions

Wow!  We have a great controversy!  A squib of a memo by the House Intel Comm has completely devoured the media.  A constitutional crisis!  Egad!  In two weeks, or maybe two months, it will be nothing.  But for now, well, very very very serious. At a minimum it has distracted everybody from Trump’s gloriously successful State of the Union speech, which was so well received until this distraction that he thinks will bring about the end of that nasty Mueller investigation.

However, it now appears that this follows an older pattern.  When really serious stuff shows up in Trump World, the world is easily distracted by some much more minor scandal that gobbles up media and public attention.  So, during the campaign there was an important moment when it was reported that emails of the DNC had been hacked by Russians and handed over to Julian Assange and publicly leaked, with these memos being drip drip drip leaked day by day through the campaign.  But did this rather serious report get any public attention?  No no no. We had a much more important scandal to distract us with its outstanding shockingness.  It was the Grab ’em by the Pussy tapes, that, shock! were supposedly going to completely upend and end Trump’s campaign.  Within a few weeks again it was no big deal, distracted by further scandals, but in the meantime the more serious matter of Russian serious intervention in the US election barely ever made it to any public attention at all, although we have been living with that attention to it ever since.

So what might this soon-to-be-forgotten memo be distracting us from (and I recognize that it is more serious than the grab ’em distraction)?  Well, buried on the inner pages of WaPo yesterday and scattered across secondary parts of the internet is a curious story that looks a lot more important than this nothing memo. Not only did Trump on the day befor his SOTU speech violate the Constitution by failing to obey a 515-5 vote in Congress to impose further sanctions on Russia for interfering in the US 2016 presidential election, but this astounding action was preceded by an apparently historically unprecedented event, the visit to Washington by the directors of all three of the top Russian intel agencies prior to his decision to ignore the mandate of the Congress.  Is anybody paying attention to this ultimate payoff to Putin for all the barely hidden Russian money in his unreleased tax returns?  Not with this wonderful distraction of this squib memo.

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