I’m getting my medical news from the front page of The Washington Post where Christopher Rowland discusses the possiblity that embrel, an anti arthritis drug, reduces the risk of Alzheimer’s dementia.

The issue is clearly incredibly important. The article raises interesting ethical, economic, statistical, and biological questions.

Better to click the link, but I will attempt a quick summary. There is evidence from anonymized insurance claims records that people who take Embrel for arthritis are less likely to develop Alzheimer’s. This hypothesis could be tested against the null of no effect with a huge long lasting extremely costly clinical trial. The patent on Embrel is about to expire. Obviously the Pfizer executives decided not to fund the trial. They also didn’t publish the retrospective study (it seems someone leaked it to Rowland).

I am most interested in the biology. Pfizer claims that they decided this, because of scientific evidence that Embrel wouldn’t work. In particular it does not cross the blood brain barrier. The argument is that it can’t help the brain without entering the brain. This is nonsense.

Embrel binds the appealingly named but nasty protein hormone tumor necrosis factor alpha (TNF-alpha). TNF-alpha promotes inflamation. It has a role in fighting tumors. It also causes cachexia wasting away of cancer patients and tuberculosis patients. It was discovered two ways. One group was purifying the wonderful TNF, the other the evil cause of cachexia which they called Cachexin. Both were surprised to discover they had purified the exact same molecule.

embrel binds and blocks TNF-alpha. It is a soluble form of the TNF-alpha receptor which competes with actual receptors which send a signal to cells when they bind TNF-alpha. It is a very important treatment for rheumatoid arthritis.

I say it doesn’t matter than embrel doesn’t enter the brain, because TNF-alpha does. If embrel binds TNF-alpha the dimer doesn’t enter the brain. If TNF-alpha in the brain causes Alzheimer’s then Embrel can reduce the risk by inactivating TNF-alpha which would enter the brain (also keeping it out of the brain but that doesn’t matter).

Pfizer’s argument is like saying that strangling someone can’t cause brain damage, because the strangler’s hands don’t enter the brain. They block oxygenation of hemoglobin which does enter the brain. The argument is silly (and effectively refuted by Rowland and scientists he interviewed).

I mean it’s obvious that inflammation spreads. That’s why cold viruses in your nose make you feel aches and pains all over (that one is interferon not TNF-alpha but the logic is the same).

There is fairly extensive evidence that inflammation has a key role in Alzheimer’s.

Of course the economics is also very clear. A huge investment in finding a new use for a molecule whose patent is about to expire is absolutely inconsistent with any duty to shareholders. This is clearly a case in which the government should fund the trial.

The statistical or methodological issue is that doctors will not trust non experimental evidence. The FDA has very strict rules for approval of a new pharmaceutical and for advertizing a new use of a pharmaceutical. They do not have to be applied to the decision of whether to prescribe a pharmaceutical off label (not for the use for which it was approved) but they are. The idea is that prescribing something with known and very minor side effects without knowing it will work is irresponsible. The logic is completely different from maximizing the expected welfare of the patient (in this case the healthy adult).

The idea that non experimental evidence is highly suspect and to be used only to propose experiments is alien to me. The rules which are called medical ethics seem to me to have very little relationship with the actions which are, in fact, morally right and morally wrong.

I think everyone should take Embrel (as soon as it is off patent and affordable). I also think there really should be a publicly funded clinical trial (which will be possible because no one will take the advice I gave in the past paragraph).

update: pulled back from comments. My knowledge of US pharmaceutical regulation is out of date (30 months out of date, but that’s out of date). I said non experimental data should be considered. So did Congress and Barack Obama and their signed act is law.

Run75441
June 5, 2019 6:59 am
It became far easier to bring things to market under the recent passage of the 21st Century Cures Act.

“The 21st Century Cures Act modified the FDA Drug Approval process. It was intended to expedite the process by which new drugs and devices are approved by easing the requirements put on drug companies looking for FDA approval on new products or new indications on existing drugs. For instance, under certain conditions, the act allows companies to provide “data summaries” and “real world evidence” such as observational studies, insurance claims data, patient input, and anecdotal data rather than full clinical trial results.”

Pharma R&D is given the normal tax break also.

Someone is lying.

The 21st century cures act

Pfizer might have decided not to publish the data back before December 13 2916. In any case, they don’t need FDA approval to publish data (1st amendment and all that). They need approval to advertise a new use of Embrel, but they can publish the data.

It seems clear that their problem is that Embrel is going off patent and will soon just be competition for their newer still on patent drugs. The news is out (as of yesterday on the front page of the Washington Post).

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I have access to too many articles on a daily basis to the point of where I can not read them all much less write on each topic. This particular one emanates from SWI or Swiss Info High Pharma Margins Squeeze Health Systems by Jessica Davis Plüss. The topic? Cancer drug pricing is rising rapidly and margins are exceeding 80% of price according to Swiss Public Television known as RTS. I find it interesting the Swiss are discussing what to do with cancer drug companies, the pricing of the drugs, and still maintain a good relationship. This is also relevant to non-cancer related drugs.

As you must know by now, healthcare pricing is controlled in Europe. Pricing and costs are more of a complaint in the US and still not an actionable item where Congress takes notice and “actually does something.” Some examples include cancer drugs such as Rituxan, etc. and far more common drugs such as Humalog, Vimovo, and the more familiar one in EpiPens (epinephrine autoinjector).

What About costs?

EpiPen is a good example of out-of-control pricing. In 2007 Mylan acquired the EpiPen brand from Pfizer; however, Mylan did not acquire the Pfizer subsidiary which manufactures EpiPen. CEO Heather Bresch reported to a congressional committee Mylan pays $69 per two-pack to the Pfizer subsidiary Meridian Medical Technologies. The price of a two-pack of EpiPens is ~10 times its cost.

To calculate the costs of manufacturing a product, one does not need to be an engineer or a PhD. Knowledge of the overhead, process, materials, and labor allows an astute and experienced layman to calculate the cost. Even so in 2016, a Silicon Valley engineering consultancy did perform an analysis of an EpiPen components and estimated the manufacturing and packaging costs at about $10 for a two-pack.

Whether the cost is $10 for a two pack or $34.50 for one EpiPen as Mylan claims, the costs do not vindicate wholesale price increases going from $100 in 2009, to $265 in 2013, to $461 in 2015, and finally $609 in 2016. With insurance some still have a sizeable co-pay. The list price at a CVS pharmacy is $733 for a two-pack. In some cases, a manufacturer will issue a coupon to a buyer which can be used at the pharmacy and shuffles the costs to the insure company leaving the user with a smaller co-pay. In the end, someone is still paying an out-of-control price.

The costs reflected in the attached chart come from Heather Bresch’s testimony to Congress. $334 of the $608 is paid out to pharmacy benefit managers (third-party administrator of prescription-drug programs for end payers, such as private insurers, and Medicare Part D plans), insurance companies, wholesalers, and pharmacy retailers leaving Mylan with $274 after rebates and fees. Deduct the cost of $69 of a two-pack paid to Meridian, and supposedly Mylan is left with $205 for each two-unit injector. After the company deducts expenses for research and development, sales and marketing, regulatory compliance, distribution and various access programs, profit drops to $100 per two-pack. As stated Mylan proposed cost structure is being challenged when compared to the expected costs of manufacture. WSJ claimed Mylan improperly assigned a tax to the expected profit which decreased Mylan’s profit by $66.

“Can You Patent the Sun?”

Times have changed since Jonas Salk and Albert Sabin developed their polio vaccines and purposely did not patent them. As reported by a Forbes analysis, by not patenting their vaccines each inventor/researcher lost out on profits in the $billions.

Jonas Salk had a simple answer when asked why he did not patent his vaccine; “Can you patent the sun?” Salk was not called the “Father of Biophilosophy” without reason . . . a philosophy taking in epistemological, metaphysical, and ethical issues in the biological and biomedical sciences.

Before he died, Salk was attempting to create an AIDS vaccine which he would not have patented either. Times have changed since the Polio vaccine.

As one commenter said, Salk could have patented his discovery; but his research was federally funded and all of his profits would have gone to the Federal Government. Research as tied to business interests has gone in a different direction from where Jonas Salk began as the law has changed. In place of social responsibility, a profit motive has taken hold.

Value Analysis

Novartis CEO Vas Narasimhan: “Cell and gene therapies are bringing about a new era of cancer medicines going beyond ‘just improving lives and are saving them.'” continuing; The new therapies are challenging the traditional model for paying for medical treatment and the industry is divided on this approach. Pricing for these one-time usage therapies are to be based on four key measures of value – the improvements they offer to patients both clinically and in terms of their quality of life, and the resulting benefits to the health-care system and society. As pointed out in the Swiss Info article, based on value to the patient, pharmaceutical companies believe they are justified in getting back $14.50 for every dollar invested in bring a new drug to market.

Pharmaceutical companies have noted four industry determinants (page viii-ix) of setting pricing as detailed in WHO’s “Pricing of cancer medicines and its impacts to the setting of medicine prices” technical report.

(1) Costs of R&D; Prices must account for the R&D costs of the approved medicine and the expenditures from investigating drug candidates for which marketing approvals did not occur, failed attempts, and the cost of capital.

(2) Costs of production and expenditures relating to product commercialization; Costs of production are operating expenses related to commercialization support, regulatory compliance, manufacturing, distribution, marketing and sales, and general administration. The marginal costs of production refer to the added costs of producing an additional unit of product.

(3) Value of medicine to patients, health care system and society; Besides setting prices according to the value of medicines, pharmaceutical companies often place more emphasis on setting prices according to income expectations or they attempt to reach their profit goals by setting prices as high as the market will bear.

(4) Sufficient financial returns to incentivize future R&D programs. The industry justifies prices of medicine by stating the return on investment needs to be sufficient to incentivize the discovery of future medicines and notes 20% of its revenues were re-invested into R&D.

A little bit of a discussion. Point 1 is stating the industry must account for failures, as well as the successes, and changes to the initial product. Point 2 is a capacity remark to which I would say if properly planned the capacity would already be there and the increase in one additional unit is minimal. No one plans to 100% of capacity. Point 3 assesses the value of human life by assigning a price to it with regard to the medicine or “what would you pay for a drink of water in the desert when there is none available for hundreds of miles.” Point 4 is new research and states we need to be able to have revenue to invest in it after expenses. I would question how much is actually needed.

And the other 80% which is now attributed to profit margin?

Typically Pharma has defended new product pricing with a justification of large investments in research and development and numerous clinical trials which can be successful or failures. Indeed CEO Vas Narasimhan pretty much says the same in bringing a product to market and also calls on additional criteria as justification for the increased pricing.

As linked to by Swiss Info, the World Health Organization (WHO) in reviewing the high prices for cancer drugs found the pricing strategy resulted in margins multiple times higher than just the R&D costs and even so when Distribution and Manufacturing costs were included in the analysis. For example, a vial of the breast cancer drug Herceptin costs approximately CHF50 to produce. In 2018 a vial was sold for CHF2,095 in Switzerland or 42 times its manufacturing cost. According to the WHO report ; for every dollar invested in cancer research, pharmaceutical companies earned on average $14.50 (CHF 14.50) in revenue.

The calculations of the cost data (chart) for two specific cancer drugs showed the final pricing for the two top treatments bear little relationship to R&D and/or Manufacturing costs. Swiss TV station’s (RTS) exposé revealed the pricing for two of Roche’s top cancer treatments are far more than just a recovery of R&D, distribution, and manufacturing costs. Herceptin costs are approximately CHF50 ($50) to manufacture and sold for CHF2,095 in Switzerland in 2018 which is 42 times the manufacturing cost. In terms of cost recovery, Herceptin has earned Roche CHF82.8 billion (85% profit margin) over 20 years or more than enough to recoup an investment and provide for R&D. A study of Novartis’s Glivec by the University of Liverpool revealed similar margin excess.

Roche media relations team member Ulrike Engels in defending the pricing strategy suggested the RTS calculations based on just Cost plus Margin data shows a fundamental misunderstanding of how prices are determined. Similar to what was stated by Novartis CEO Vas Narasimhan, Roche/Engels pricing of certain drugs which are life saving are based on the benefits or improvements in the treatment of patients both clinically and in their quality of life afterwards and the resulting benefits to the health-care system and society. It is not just a cost to bring a product to market plus a respectable margin. Neither is it a realization by Roche of having recovered investment costs and gained sufficient funds for R&D, the Failures, the Trials, and the Capitalization, it can relax its pricing.

Older Drugs

Pharma companies are also using the “value-based” analysis to determine pricing for old drugs even without improvement. This is precisely what HHS Alex Azar did at Eli Lilly with Humalog a decades old drug used to treat diabetes. The six million diabetic Americans watched as insulin (Humalog) prices tripled under Azar’s watch at Eli Lilly from 2007 to 2017. During his tenure as president and vice president, Eli Lilly raised the price of Humalog by 345% from $2,657.88 per year to $9,172.80 per year. The resulting pricing shock forced some patients to attempt rationing their taking of the product which in some cases caused death.

According to a JAMA study in 2017, the rising cost of healthcare and “after accounting for inflation, healthcare expenditures increased $933.5 billion from 1996 to 2013.” 50% of the increase in healthcare costs during that period was simply due to higher prices. Be that as it may, different chronic diseases have different patterns of price increases. The biggest increase was seen in diabetes care and driven largely by the rising costs of pharmaceuticals. During that period of time, Diabetes care increased $66 billion in cost of which an approximate two thirds of it being solely due to the increased cost of the pharmaceuticals used in treatment.

To be redundant, value based analysis methodology considers the extra years of life gained, the quality of life during the time period lived, and the healthcare savings gained (an overall cost reduction in treatment), in addition to other benefits, to determine the value of the drug to a person and society in which to set a price. This is the argument being made. Roche’s Herceptin targets HER2-positive breast cancer, an aggressive cancer which occurs in younger women, and claims the benefits of treatment being particularly high thereby deserving of a higher price.

Novartis applied the same “value-based” analysis to justify pricing for Kymriah used to treat unresponsive b-cell acute lymphoblastic leukemia when there are no other options for them or their families. It is a one-time treatment with follow-up treatments far less frequent than traditional therapies.

The Institute for Clinical Economic Review — an independent expert body assessing cost effectiveness of medical treatments — assigned a cost effectiveness value of up to $1,688,000 for Kymriah for its use in children. The value this treatment offers considered the four key measures to set the Kymriah list price for pediatric use at $475,000, which is well below the cost effectiveness value set by ICER, and $373,000 for rapidly progressing adult cancers.

Social Responsibility Over Profits

The questions can be asked of whether it is morally responsible or acceptable for a company to set the valuation/pricing of a product used to save a life at a level tens of times higher than actual cost to bring it to market? Is it also morally responsible or acceptable to increase an older product’s pricing when the costs have been recovered many times over? Yet, this is what the corporate expectation is for cancer drugs with its pricing and also for older drugs such as Humalog, Vimovo, and EpiPen applications based upon a value analysis to patients.

Run75441 (Bill H)

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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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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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run75441: I have been fortunate to run across incredibly intelligent people here and other places who continue to impress me with their command on particular topics. Esmensetoo has an excellent knowledge of healthcare and healthcare insurance and how it has evolved. I was not expecting quite this much. It does cover all of the bases and there is still more to be had. I hope you enjoy reading it as much as I did.

In the 1980s when managed care was just coming into being in a substantial way, I worked with every major insurer in my region — Blue Cross, Blue Shield, Group Health (a Kaiser-type care provider that is now, in fact, owned by Kaiser), as a marketing professional. I also worked with several major regional health care providers, including the Sisters of Providence, who were the founders of the first hospitals in our region in the mid-19th Century. In the 80s they were trying, under the new deregulated environment, to create a health insurance vehicle too — that would use their hospital network. Ultimately, they were never able to worked out the details of a plan that both met what they saw as their responsibilities to the community and thought would be financially viable.

By the end of the 80s the late-1970s and later deregulation that led to “managed care” also encouraged insurers, at that time that primarily meant Blue Cross and Blue Shield, that had been founded as non-profits and had operated as such for all of their history, to become for profit (earning those in the executive suites HUGE paydays. It) was also bringing a lot of questionable new for-profit insurers into the health insurance market — many were little more than scams; adopting all the questionable practices we are all later became too familiar with — for instance, finding all kinds of clever ways to deny coverage when premium payers became ill. Also, as “managed care” which was supposed to control the cost of premiums and care that had started inflating in the 70s drove non profit insurance out of the market premiums began to really soar while what and who was covered was becoming more restricted. Small businesses started dropping insurance for workers and large insurers started offering lesser benefits at higher cost.

By the early 90s people were demanding reform, again. (Which, in my opinion, played an important role in Clinton’s election — and then the Democrats failure to pass anything in his first 2 years, along with other things like the bank scandal, contributed to their loss of the congressional majority for the first time in 40 years).

In my state, Washington, demand for reform was a really big issue for almost everyone, certainly including me. In 1992 I went to work for a local Democratic political consulting firm that was running the campaign of a reform candidate for Insurance Commissioner. She ran on setting standards to keep the scammers out of the state, setting up a system of state support for low cost insurance for the employees of small businesses, and developing community clinics that would treat people on a sliding scale. The insurance companies of course pushed back and demanded things that compromised her vision. But she still got most of what she ran on done. We ended up with system that was far from perfect but that did, did keep the scammers out of the market and the community clinics were an important resource. But the state supported small business insurance had too much paperwork and was especially unworkable for people whose work hours varied from quarter to quarter — which is common for low wage workers. And, unfortunately, by the time Obamacare passed, with similar reforms in terms of what insurers were required to provide, we only had one insurer left in the state who was offering Individual Insurance. It was excellent insurance but very expensive.

Thanks to those reforms we were in a good position for an easy transition to the ACA. We had a little technical difficulty right out the gate (embarrassing for state that sees itself as a tech leader) but mostly the transition was painless. The nonsense the Republicans and Trump have been indulging in has created problems though.

This is already too long — so I have no time to back up these three points but here are 4 things that many misunderstand about the history of our health care system that makes it difficult to have intelligent conversation about reform:

1. Our health care system was not created by the “free market.” Americans traditionally saw health care as a community responsibility. Community taxes, in addition to charity, and at times some non-profit insurance-like schemes, were used to help support community hospitals from colonial days on, often these hospitals were associated with religious denominations or orders but not always.

2. The Federal government also was involved in health care AND insurance very early — creating a hospital system for seaman in the late 18th century and requiring those using the system to purchase insurance to help cover the cost of care. In the 19th century that Marine Hospital Service also began to support medical research. The NIH, which has been very important in both funding research and doing research, was created out of the Marine Hospital Service.

3. Health insurance was not created by the “free market’ either. IT IS NOT RISK INSURANCE — and the commercial insurance industry avoided it like the plague for most of our history because they understood that it wa sn’t risk insurance but rather a way of socializing costs — and that it was unlikely to be profitable (while actually insuring care). Health insurance was created by the hospital industry and it was non-profit until “reformers ” de-regulateded it in order to make it easier for insurers to profit by choosing who and what would be covered and what providers would be paid (something, obviously, the AMA objected to).

4. The connection between employment and insurance was not created by FDR. From the very beginning hospitals identified employment groups — people who, like the seaman, and like the loggers in my state that the Sisters of Providence provided with a crude-insurance plan — $1 a month would insure they would have care in the very likely case that they were injure d — while allowing the Sisters to provide care to the poor too. Illness and injury deprived people of their ability to work and earn. So it made sense to ask the employed, especially those in dangerous occupations — to pay something while they were well and earning, so there would be resources available to care for them when they were not.

by run75441 (Bill H)

Tags: Esmensetoo, healthcare Comments (7) | Digg Facebook Twitter |

I had thought these types of treatment had gone by the wayside in treatment during the last year of life. According to an Medscape article they have not.

“‘Physicians should carefully consider whether the prescribed drugs are likely to achieve their benefit within the patient’s remaining lifetime,’ the authors concluded. The study included 151,201 patients ages 65 years and older who died in Sweden at a mean age of 81.3 years from 2007 to 2013. ‘The use and cost of preventive drugs during the last 12 months of life were the main study outcomes.’ The drugs of ‘questionable benefit’ assessed in the current study included antidiabetic drugs, antihypertensives, statins, and bisphosphonates medications for the treatment of chronic anemia and vitamin and mineral supplements.’

Receipt of these long term preventative drugs added 20% to the cost of treatment during the final year of life. ‘The median drug cost during the last year of life was $1,482 (interquartile range $700-$2,896).'”

By run75441 (Bill H)

Tags: cancer treatment, pharma Comments (8) | Digg Facebook Twitter |

Spoiler: It isn’t working. Charles Gaba at ACA Signups had this up.

In an excellent scoop by Dan Diamond and Adam Cancryn this morning, Politico reports CMS Administrator Seema Verma, the person in charge of Medicare/Medicaid and who takes great joy in trashing Medicare and Medicaid, has spent millions of dollars on partisan consulting firms to boost her image.

The Trump appointee who oversees Medicare, Medicaid and Obamacare quietly directed millions of taxpayer dollars in contracts to Republican communications consultants during her tenure atop the agency and including hiring one well-connected GOP media adviser to bolster her public profile.

The communications subcontracts approved by CMS Administrator Seema Verma was routed through a larger federal contract and described to POLITICO by three individuals with firsthand knowledge of the agreements. The move by the CMS Administrator represents a break from precedent at the agency. Managed by Verma’s deputies, the deals came over the objections of some CMS staffers who raised concerns about her push to use federal funds to pay GOP consultants to amplify coverage of her own work. CMS has a capable communications shop which includes about two dozen people who handle the press.

The good news is that Congress is finally on the case now that the Democrats have the reins.

On Friday, House Energy and Commerce Chairman Frank Pallone called for an HHS inspector general probe into CMS’ use of CMS funding for communications consultants, calling it a “highly questionable use of taxpayer dollars.”

IN a statement, the New Jersey Democrat said; I intend to ask the HHS OIG to immediately begin an investigation into how these contracts were approved, whether all regulations and ethical guidelines were followed, and why taxpayers are stuck paying for these unnecessary services.”

For the record, Seema Verma is also the one who slashed the HealthCare.Gov marketing and navigator program budgets by 90% and 80% respectively over the past year and a half, allegedly in the interest of . . . “providing more efficient, targeted outreach” (via one of her press releases from last year).

Charles; I’m not sure exactly what sort of “bolstering of her public profile” these taxpayer-funded GOP image consultants are doing, but I would imagine, it is crap and similar to sending out promotional mailers like this one which showed up in my in box yesterday . . . sent from the official CMS Press Office:

Click on image to enlarge it.

Tags: ACA Signups, Charles Gaba, CMS Comments (2) | Digg Facebook Twitter |

Brad DeLong got a huge amount of attention by saying it was time for neoliberals such as Brad DeLong to pass the baton to those to their left. Alarmingly, he seems to have written this first on twitter.

Zach Beuchamp rescued it from tawdry twitter to now very respectable blogosphere with an interview.

One interesting aspect is that Brad has very little criticism of 90s era Brad’s policy proposals. Basically, the argument is that Democrats must stick together, because Republicans are purely partisan and no compromise with them is possible. I absolutely agree with Brad on this.

But I also want to look at criticisms of Clinton/Obama center left policy as policy.

Brad tries to come up with 2 examples

I could be confident in 2005 that [recession] stabilization should be the responsibility of the Federal Reserve. That you look at something like laser-eye surgery or rapid technological progress in hearing aids, you can kind of think that keeping a market in the most innovative parts of health care would be a good thing. So something like an insurance-plus-exchange system would be a good thing to have in America as a whole.

It’s much harder to believe in those things now. That’s one part of it. The world appears to be more like what lefties thought it was than what I thought it was for the last 10 or 15 years.

Now monetary vs fiscal policy is only considered right vs left because of the prominence and fanaticism of Milton Friedman. Is see no connection between laser eye surgery, hearing aids, and private health insurance. Medicare for all is not a National Health Service (note I am not conceding that a national health service would be bad for medical innovation). Brad did not advocate insurance/plus/exchange system in 1993. He (and Bentson, Summers and Rubin) advocated a payroll tax financed system not the Clinton-Clinton and Magaziner mess. I think he is stretching to get a second example.

I think the first isn’t really left vs right and the second is and always was a bad political calculation. IIRC Obama certainly said that he thought single payer was better policy but politically impossible. That was the general line on the center left wonkosphere. I think the case for insurance-plus-exchange was at most a bad political argument disguised as a bad policy argument.

In another twitter thread (no not the one where he says twitter is a horrible medium for serious discussion) Paul Krugman comments

I want to focus on two of his tweets

Last point: wages. Here’s where research has convinced me and others that wages are much less determined by supply and demand, much more determined by market power, than we used to believe. This implies a much bigger role for “predistribution” policies like minimum wage hikes 10/

Pro-union policies, and more than we used to think. “Let the market do its thing, but spend more on education/training and a bigger EITC” no longer sounds like wisdom 11/

I listed this as the one economist’s mea culpa based on empirical evidence which came to my mind. A lot of center left economists used to oppose minimum wage increases and were convinced by empirical evidence (mostly by Card and Krueger) that this is actually good policy. But I don’t see any problem with the EITC. Rather, economics 101 based arguments against the minimum wage and unions have been undermined by evidence*.

I think Krugman’s problem with “a bigger EITC” is political. It appears on the Federal budget so deficit hawks won’t allow a really huge increase. In contrast, people can think firms pay the minimum wage, so increasing it sounds like a cheap way to help the working poor.

More generally, I don’t see any reason to abandone redistribution (like the EITC). In fact, I think that is both excellent policy and political dynamite. I note that Bill Clinton and Barack Obama campaigned promising to raise taxes on the rich and cut taxes on everyone else. Also they won. Other Democrats didn’t promise that and they lost. A more progressive income tax is a relatively market respecting policy long supported by left of center economists. Oh and also Alexandria Ocasio Cortez. I don’t think there is any evidence against the Clinton 1993 tax increase combined with EITC increase.

The fact that it is totally obvious that it is good politics (rejected absolutely by the Republican party and supported by most self identified Republicans) doesn’t mean that it is too obvious to stress. It means debating redistribution vs predistribution is a distraction (which one here is not like the others)?

I personally have criticisms of Bill Clinton type neoliberalism after the jump

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In parts of Livingston and Oakland counties, the people have been warned not to eat the fish from the Huron River and Kent, Strawberry, Zukey, Gallagher, Loon, Whitewood, Base Line and Portage lakes as well as Hubbell Pond due to the fish being contaminated with PFAS and similar chemicals coming from industries. In 2016, Michigan started to tell people about the impact of PFAS and how dangerous the PFAS and PFOAs are.

PFAS/PFOA are part of a class of man-made chemicals used in many industrial and consumer products to make the products resist heat, stains, water, and grease. Product Examples include: Teflon® cookware, waterproofing fabric and coating on fast food wrappers.

Former Army reservist Spc. Mark Favors, his relatives, and family have lived around Fort Carson and Peterson Air Force Base for years drinking and bathing-in base and off-base water for years. The level of PFAS and PFOA on base around Peterson Air Force Base has been established at 79 to 88,400 parts per trillion on-base wells and 79 to 7,910 parts per trillion in public and private drinking wells off base.

It was not until the EPA published its 70 parts per trillion guidelines did the DOD claim it began to understand how harmful exposure could be and voluntarily took action. Spc. Mark Favors does not buy the excuse. The issue has been explored in-depth by the Colorado Springs Gazette, which produced a timeline dating back to the first concerns about the foam used to fight fires in 1962. Fort Carson stopped using the firefighting foam in 1991 stating, “Firefighting operations that use AFFF must be replaced with nonhazardous substitutes.”

In Michigan, it will take a Flint-sized emergency before it begins to take aggressive action with businesses dumping contaminated water in company drainage pipes going to water reclamation plants. Then too, Livingston County is the richest in income in the state and is also 96% white, an advantage the county has over the City of Flint.

Fifty year old Mark Favors can count at least 16 relatives from around the area who have been diagnosed with cancer; 10 have died. Six of those relatives have died since 2012, including his father at age 69 and two cousins, ages 38 and 54.

“In my family alone, we have had five kidney cancer deaths,” Favors said. “And those people only lived in the contaminated area.”

Many of Favors’ relatives lived near Peterson Air Force Base, where scores of both on-base and off-base water sources have tested significantly above the Environmental Protection Agency’s recommended exposure of 70 parts per trillion of perfluorooctane sulfonate (PFAS) or perfluorooctanoic acid (PFOA). The compounds were part of the military’s firefighting foam until just last year. The same compounds in the foam have been linked to cancers and also developmental delays for fetuses and infants.

In a recent March 6, 2019 House subcommittee hearing, Mark Favors was among those in attendance as the subcommittee was questioning the actions of the Environmental Protection Agency and Department of Defense representatives over the decades long use of PFAS, the failure to regulate it’s usage, provide adequate protection from its usage, and monitor the safe disposal to prevent contamination of ground water and the environment. Knowing its dangers, a reasonable person would have found an alternative to its usage as demonstrated by Fort Carson in 1991. Obvious, some elements of the military were not of that mind.

With a large degree of politeness, House Oversight and Reform subcommittee on the environment chairman Rep. Harley Rouda, D-CA commented:

“To put it charitably, it is unclear why DoD feels justified in passing the buck to the EPA, particularly in light of the evidence suggesting DoD’s awareness of the toxicity of the chemicals since the early 1980s.”

If stationed at a military bases (and who has not been for some period of time?), this is a big issue as many of us were using the water supplied to us at places such as Camp Lejeune where we were drinking and showering in water contaminated with chemicals such as benzene. For those who were at Camp Lejeune for at least 30 days, there is now a list of disorders which the VHA will accept as being attributed to exposure to base water. Some of us have disorders on that list and some of us do not. There are many other military sites where former military and civilian personnel have complained of disorders and illness which they believe is attributed to the bases they were stationed during their enlistment or working as civilians.

In Michigan, there is a site where you can get an idea of how bad the issue is in and around your community. All known PFAS sites in Michigan and check your own area (at the bottom you scroll to find your county and township/community).

Many knowledgeable sources believe the 70 parts per trillion is still too high.

by run75441 (Bill H)

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