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

Democratic Presidential Candidates Addressing Maternal Healthcare

Back in April, I finished up an article for ConsumerSafety.Org called A Woman’s Right to Safe Healthcare Outcomes. The topics covered in this as given to me by ConsumerSafety.Org were Clinical Trials, Essure, and Maternal Mortality. All of the topics dealt with women’s healthcare. Of the three issues addressed, I found Maternal Mortality to be the most compelling.

I told the story of a white upper middle class couple, Lauren Bloomstein a nurse and her husband Larry a surgeon. They went to the hospital to have their first baby. Lauren was a healthy young woman who did everything right. Unfortunately Lauren’s OB before and during her delivery missed many of the signs she was suffering from preeclampsia or high blood pressure. Lauren died after giving birth to a healthy baby girl. It is not unusual for doctors failing to heed the warning signs a women or her symptoms are alerting them too.

The warning signs of life-endangering problems were there, were missed (pain in the kidney area), or ignored (abnormal high blood pressure for Lauren). Excuses for other causes of the 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 chart.

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).

In my email account, I found my usual Health Affairs article with a lead off title “The Maternal Health Crisis: Policies of 2020 Candidates

“Many of the Democratic presidential candidates met in Columbia, SC at the Planned Parenthood Women’s Health Forum to share their reproductive health proposals, including plans for maternity care. On Thursday, June 26th, they will engage in their first debate. Donald Trump launched his re-election bid on June 18th, 2019. While his campaign website does not include any specific reference to maternal mortality, members of his administration have recently brought attention to rural maternal health challenges.

This renewed focus on maternity care is desperately needed: U.S. rates of maternal mortality are the highest in the developed world and have been rising since the 1990s, with women giving birth today more likely to die in childbirth than their mothers. These adverse outcomes are also marked by significant racial disparities, with non-Hispanic black and American Indian/Alaska Native women at least 3 times as likely as non-Hispanic white women to die around the time of childbirth.”

About time.

run75441 (Bill H)

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Supreme Court to hear cases over ACA risk-corridor funds

Supreme Court to hear cases over ACA risk-corridor funds

“The U.S. Supreme Court said Monday it will take up cases over whether the federal government must pay billions of dollars to health insurers that sold coverage on the Affordable Care Act exchanges.

Letter to The Editor – Modern Healthcare Alert

If you are going to report on this particular incident with the Cromnibus Act which passed December 11, 2014, why not give the complete history of how the Risk Corridor Program was stymied?

Initially, then Budget Committee Republican Ranking Member Senator Sessions wrote a letter to the GAO asking whether the Risk Corridor payments were being appropriated correctly. In a letter back to Sessions the GAO said Agencies can only appropriate funds at the discretion of Congress. Funding had not been properly secured for the Risk Corridor Program. This effectively stopped any new funding from being used for the Risk Corridor Program; however, funding could be transferred from other healthcare programs.

With the aid of House Energy and Commerce Chair Fred Upton and House Appropriations Chair Jack Kingston, Section 227 was inserted into the Cromnibus Act.

“None of the funds made available by this act from the Federal Hospital Insurance Trust Fund or the Federal Supplemental Medical Insurance Trust Fund, or transferred from other accounts funded by this act to the “Centers for Medicare and Medicaid Services – Program Management “ account may be used for payments under section 1342(b)(1) of Public Law 111-148 (relating to risk corridors).”

This was far more nefarious than Congress as a whole making this budget neutral and its hides what Republican Senator Sessions, and House Representatives Upton, and Kingston did to sabotage the ACA, drive up premiums, bankrupt Coops, cause companies to leave the healthcare exchanges, and cause constituents to lose coverage.

Yes indeed, Congress did vote for the Cromnibus Act in the waning day(s) left before a government shut down. Section 227 was inserted during those last few days and more than likely overlooked in the process of passing a budget bill so the government would not shut down.

run75441 (Bill H)

Should these companies win at SCOTUS review, the costs and blame should be assigned to these three as their motives were “solely” party politics over country thereby penalizing citizens.

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Does President Trump Read “JAMA Network Open?”

It is doubtful Trump reads much beyond his own signature on Executive Orders and Twitter commentary. Someone is attempting to align him with current thinking creating a persona of his being a thoughtful and reasoning president as opposed to . . . ?

In “Again, Healthcare Cost Drivers Pharma, Doctors, and Hospitals ,” I had posted stats from a 2016 JAMA paper covering the period from 1996 to 2013. Healthcare costs had increased $1 trillion of which 50% was due solely to pricing. One significant factor in the JAMA report was the $66 billion increase in costs for diabetes treatment of which $44 billion was due to pharmaceuticals pricing. One impact to diabetes treatment was Eli Lilly’s increases for Humalog which was $21 per vial in 1996. By 2017, the price increased to $275 (700%) for a vial, a one-month supply. Humalog is a decades old drug and the manufacturing has not changed significantly.

“JAMA Network Open” has issued an end of May 2018 paper on pharmaceutical pricing trends covering the years from the period 2012 – 2017, “Trends in Prices of Popular Brand-Name Prescription Drugs in the United States.” The question it asks:

• What are the prices of top-selling brand-name prescription drugs in the United States and how have these prices changed in recent years?

answer:

• In this evaluation of 49 common top-selling brand-name drugs; 78% of the drugs have been available since 2012, have seen an increase in insurer and out-of-pocket costs by more than 50%, and 44% have more than doubled in price.

and concludes:

• Brand-name drug pricing associated with government-protected market exclusivity is likely to continue to increase and warrants greater price transparency.

Similar to what President Trump has proposed which “still” does not empower constituents to seek alternatives and typically the alternatives are just as costly.

Study Methodology

Data was obtained of 35 million individuals from the Blue Cross Shield Axis (data base) for the time period of January 2012 through December 2017. The researchers reviewed prescribed drugs exceeding $500 million in US sales or $1 billion in worldwide sales.

Within the identified parameters of 2012-2017 sales, 132 brand-name prescription drugs were identified. 49 of the 132 top-selling drugs exceeded 100 000 pharmacy claims, substantial cost increases among these drugs was experienced within the inclusion parameters with a 76% median cost increase, and 48 of the drugs had regular annual or biannual price increases.

Thirty-six of the 49 drugs were available since 2012. Twenty-eight had experienced an increase in insurer and out-of-pocket costs exceeding 50% and 16 more than doubled in price. Insulins such as Novolog, Humalog, and Lantus and tumor necrosis factor inhibitors such as Humira and Enbrel experienced highly correlated price increases coinciding with some of the largest growth in drug costs.

The results of the study revealed the median sum of out-of-pocket and insurance costs paid by patients or insurers for common prescriptions and presented both annually and monthly.
Pricing increases for 13 new drugs from January 2015 through December 2017) and entering the market in the last 3 to 6 years was not different than those (36) having been on the market longer, a 29% increase [median] from January 2015 through December 2017.

Nor did the study differentiate between drugs with or without a FDA approved therapeutic equivalent (number of drugs, 17 vs 32; median, 79% vs 73% price change).

Changes in prices paid were highly correlated with third-party estimates of changes in drug net prices (ρ = 0.55; P = 3.8 × 10−5), suggesting that the current rebate system incentivizes high list prices and greater reliance on rebates resulting in increased overall costs.

“The study concludes the growth of drug spending in the United States associated with government-protected market exclusivity is likely to continue. Greater price transparency is warranted.”

Interpretation? Pharmaceutical companies (and I will include companies such as Mylan [EpiPens]) are using the patent drug laws and resulting exclusivity time period to maximize profit margins ($14.50 for every $1 invested [WHO]) protecting their products from competition. A similar exclusivity holds true for generic products also (time periods for the introduction for a similar generic product). “Can You Patent The Sun (Jonas Salk)?

I sat over dinner with one Exec. VP from a major pharmaceutical company who confirmed what I had said in an earlier post (Can You Patent The Sun?) and here. A new pricing strategy is being used by pharmaceutical companies which maximizes return based upon benefits achieved in treatment, life, healthcare system, and in society. It is a well thought out reasoning being delivered by intelligent purveyors of healthcare supplies portraying a modicum of caring or concern for societal welfare while pursuing the profit motive. Novartis CEO Vas Narasimhan (not the one I talked to);

“Cell and gene therapies are bringing about a new era of cancer medicines going beyond ‘just improving lives and are saving them.’ 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.”

The pricing application is not limited to new drugs, cancer meds and gene/cell therapies; it is also being applied to older drugs and also generic replacements.

Findings:

Between 2012 – 2017, the study reveals an industry wide increase in costs for top-selling brand-name prescription drugs and less costly generic replacements. The increase in costs, biannual, and annually for 36 pharmaceuticals since 2012 can also be seen in newer drugs coming on the market after 2012. A pattern or practice of pricing determination based upon 4 values in the pharmaceutical market which will continue into the foreseeable future.

This particular chart depicts annual net price and annual paid price increases showing the percentage increases. This becomes more interesting where I cover “rebates” and whether the reduce costs.

Given median cost increases of 9.5% annually, the yearly increases will result in a doubling of costs for brand name drugs in this study every 7 to 8 years.

New and old brand-name competition does little to control rising costs of products which can be used interchangeably (hence this shoots transparency in the foot for constituents talking to pharmacists) such as Humira and Enbrel or diabetes drugs such as Humalog, Humulin, and Novolog. “Relative cost changes are highly synchronized” resulting in large increases over the last 6 years. As mentioned there appears to be a pattern or practice of pharmaceutical companies acting in concert.

There is little evidence of price changes associated with the existence of therapeutic equivalents such as generics, biosimilar drugs, or drugs entering the market later.

Legislated pricing transparency may lead patients to seek alternative drugs if available which may result in different pricing trends than what was observed over the six years of when the study was done. The impact of such is unknown as is the likelihood of those trends as they may already be in progress due to volume changes or speculation of volume changes due to expiration of exclusivity.

Neither was there evidence of products entering the market 3 to 6 years ago having different trends compared with other drugs in the first years of availability.

Transparency is need in the costing of drugs and the setting of prices by manufacturers. Only in the US, does the manufacturers of the product set the pricing. In Europe, pricing is influenced by governments.

Research and Development

There is a balancing act between reasonable pricing for consumers and the costs for bringing innovative drugs to market. The United States does provides strong patent laws globally. However, legal strategies by the pharmaceutical industry such as patenting the peripheral aspects of a drug (think EpiPen and its cap) extend protections beyond the original patent and delay generic and biosimilar versions. Furthermore, if a generic version brought to market by one company can not be used in the same manner by following the instructions of the brand name version; the company of the patented version can ask the FDA to block the generic version (again think Mylan’s Brand EpiPens and the TEVA generic [See; “Can You Patent The Sun?“]).

Healthcare and pharmaceutical companies can maintain exclusivity and pricing as set by the manufacturer much longer and well beyond the original patent limits with a range of new innovations. In similar countries as the US as found in western Europe, governments set pricing. The end result is a large discrepancy in pricing between the US and European countries for the same drug.

It is near impossible for private insurers to negotiate pharma pricing and Medicare is forbidden to do so. The Institute for Clinical and Economic Review’s value-based price benchmark is one approach to establish appropriate pricing. Using the four key measures the ICER assigned a cost effectiveness value of up to $1,688,000 for Kymriah for its use in children. This analysis takes into account all of the R&D cost in developing a drug, bringing it to market, and the cost save as measured against other therapies. Using the same ICER 4-point value-based analysis and understanding the range effectiveness determined by the ICER, Novartis set Kymriah list price for pediatric use at $475,000, well below the ICER’ cost effectiveness value, and $373,000 for adult cancers.

So, how is this drug paid for by the less financially endowed patients? Coupons by the manufacturer and rebates to the insurance payor set a net price for the patient which is price and profit neutral.

Rebates

Several points; Transparency of how rebates occur and affect net pricing is limited as to the impact of them on the pharmaceutical industry and healthcare insurance, rebates on list prices set by manufacturers are given by the manufacturers to commercial healthcare insurance and some government programs not including Medicare, and the rebates will vary by drug, by payer, and constitute “16% of all private insurer-branded drug spending returned as rebates in 2016.”

Whether rebates lower or increase costs is debated due to the lack of transparency of their application.

Due to the lack of data, this particular JAMA study used third party information or estimates of net price data on each drug. The observations did reveal a high correlation between increases in the rates of insurer and out-of-pocket costs paid for each drug and the net prices (ρ=0.55). The association suggests the offered industry supposition of higher list prices and greater reliance on rebates reducing costs may not be true.

Instead and a bit redundant by me, the paper offers an opposing supposition of increases in list prices, and the resulting increases in insurer and out-of-pocket costs paid, may coincide with increases in net prices, which in turn make these drugs more expensive overall. Seemingly biannual price increases should not be considered benign pricing strategies to offset paid against net price discrepancies in the current rebate system.

If true, this would be a façade making it appear rebates have an impact on final costs to the healthcare system and pricing to the patient. Rebates may only be a shuffling $dollars around.

Greater transparency of the process is needed to determine what is and what is not a cost save. The transparency is not for the purpose of patients deciding what to buy or pharmacists to recommend alternatives; although, it could be used by constituents to support healthcare proposals to bring prices down.

A healthcare system and its coverage without a foundation or mechanisms to control or account for costs is simply a blanket to pricing and hides its impact.

Run75441 (Bill H)

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Two articles to think about, one on opioids, the other billing for hospital care

Via Naked Capitalism:

Place based economic conditions and the geography of the opioid overdose crisis

By Shannon Monnat, Associate Professor, Syracuse University. Originally published at the Institute for New Economic Thinking website

Over 400,000 people in the U.S. have died from opioid overdoses since 2000. However, there is widespread geographic variation in fatal opioid overdose rates, and the contributions of prescription opioids, heroin, and synthetic opioids (e.g., fentanyl) to the crisis vary substantially across different parts of the U.S. In a studypublished today in the American Journal of Public Health, we classified U.S. counties into six different opioid classes, based on their overall rates and rates of growth in fatal overdoses from specific types of opioids between 2002-04 and 2014-16 (see Figure 1). We then examined how various economic, labor market, and demographic characteristics vary across these different opioid classes. We show that various economic factors, including concentrations of specific occupations and industries, are important to explaining the geography of the U.S. opioid overdose crisis.

 

1 in 6 hospital patients get a surprise bill for out of network care

By Rachel Bluth, Kaiser Health News reporter. Originally published at Kaiser Health News.

About 1 in 6 Americans were surprised by a medical bill after treatment in a hospital in 2017 despite having insurance, according to a study published Thursday.

On average, 16% of inpatient stays and 18% of emergency visits left a patient with at least one out-of-network charge. Most of those came from doctors offering treatment at the hospital, even when the patients chose an in-network hospital, according to researchers from the Kaiser Family Foundation. Its study was based on large employer insurance claims. (Kaiser Health News is an editorially independent program of the foundation.)

The research also found that when a patient is admitted to the hospital from the emergency room, there’s a higher likelihood of an out-of-network charge. As many as 26% of admissions from the emergency room resulted in a surprise medical bill.

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Technology and Productivity. What went wrong?

Kevin Drum wrote a typically brilliant post on absurdly high estimates of the growth of the number of health care administrators. I was very interested in one little passage. My comment.

Dear Kevin

You used to work for a tech company and IIRC in public relations. Now your day job is as a blogger-journalist. Don’t quit your day job.

you wrote “Once you take into account the growth in health care generally, the share devoted to administration has gone up by 50-100 percent. That’s a lot! But it’s also not that surprising. In 1970, the health care industry spent approximately $0 on IT management. Today they spend a bundle, and all of that is admin overhead. ”

You are saying a huge improvement in information technology explains part of the increase in administrative costs. Better technology is supposed to be more efficient not less efficient. If IT weren’t a waste of money, it would cause lower not higher costs (I’m embarrassed to type a tautology but there it is).

You think it is obvious that IT is a waste of money. This might be excellent work for a blogger journalist (I wouldn’t be surprised if you are right). But it sure suggests you have more of a past than of a future in tech pr.

I am being sarcastic and am also totally serious. In fact, I am quite confident that you are right that IT has caused an increase in administrative costs, and that the use of IT in business administration has been a total waste of money. The reason is the 4th law of thermodynamics — work expands to fill the allowed space. Also known as Parkinson’s law.

I’m sure the number of administrative tasks which can be performed per person hour has increased enormously (this is counting the information techs’ hours too). But I think the amount of the cost of each unit of product which goes to pay salaries of administrators has gone up. The reason is that the number of administrative tasks which are assigned or required is not equal to the number which are necessary or even useful (which I would guess is a low number). Rather it is the number which can be done without hiring more people who have old job descriptions. So the non info techie administrators are kept and given more tasks. This means that the newly hired info techies are an added expense, unless the new tasks given to other administrators are actually useful in some way.

I am fairly sure that they aren’t useful.

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Interesting Healthcare Outcomes . . .

Opioid Overdose Now Provides 1 in 6 Donor Hearts,” Ashley Lyles, MedPage Today

Overdose-death donors have accounted for a rapidly growing proportion of cardiac allografts, with a 14-fold increase from about 1% in 2000 to now 16.9%, “consistent with the rising opioid epidemic,” reported Nader Moazami, MD, of New York University Langone Health in New York City, and colleagues in The Annals of Thoracic Surgery. Earlier findings:

A total of 1,710 of 15,904 (10.8%) cardiac transplantations were from ODDs, approximately a 10-fold increase from 2000 (1.2%). ODDs were more frequently older than 40 years of age (87.2% vs 70.1%; p < 0.001), had higher rates of substance abuse, were more likely hepatitis C positive (1.3% vs 0.2%; p < 0.001), and less frequently required inotropic support at the time of procurement (38.4% vs 44.8%; p < 0.001). Overall survival was not different between the groups (p = 0.066). Discarded ODD allografts were more likely to be hepatitis C positive (30.8% vs 5.3%; p < 0.001) and to be identified as conveying increased risk by the Public Health Services (63.3% vs 13.2%; p < 0.001), but they were less likely to be discarded because of a diseased organ state (28.2% vs 36.1%; p < 0.001).

In many states, overdose-death donors comprised greater than 25% of cardiac allograft donors in 2018, with a high of 50% in Delaware.

While there have been concerns regarding allograft function and infectious risk, the researchers noted overall survival was the same between recipients of overdose-death and non-overdose-death donor organs (P= 0.066).

The discard analysis of donors who had at least one organ transplanted but not the cardiac allograft showed overdose-death donor hearts (7.4% of all discards) were: less likely to be discarded due to being in a diseased organ condition than those donors who died of other causes (28.2% vs 36.1%; P less 0.001), more likely deemed higher risk by Public Health Services (63.3% vs 13.2%; P less 0.001), and more likely to be hepatitis C positive (30.8% vs 5.3%; P less 0.001).

Even with the hazards of using a heart from an opioid abuse donor, survival outcomes of recipients of hearts that come from donors that have died from opioid overdose are equivalent to ones that we have traditionally been using, and because of this we believe that there are more donors out there that can be utilized.

STIs: ‘Hidden, Silent, Dangerous’ Global Epidemic, Molly Walker, MedPage Today

World Health Organization (WHO): “no substantial decline in global STI prevalence since 2012”

An approximate one in 25 people worldwide had at least one curable, sexually transmitted nonviral infection in 2016.

The incidence of gonorrhea, chlamydia, trichomoniasis and syphilis amounts to about one million new infections each day, and more than 376 million new cases annually. Additionally as Melanie Taylor MD and medical epidemiologist at the WHO Department of Reproductive Health and Research (and colleagues noted), “there has been no substantial decline in the number of new infections since the data was last updated in 2012.”

Also of the WHO Department of Reproductive Health and Research Teodora Wi MD; “We cannot sweep [sexually transmitted infections] under the carpet and pretend they don’t exist while we continue to stigmatize people living with STIs, neglect their care. and fail in prevention.”

STIs are a “hidden, silent, dangerous” epidemic, and are still “persistent” globally, despite an increase in education about the dangers of sexually transmitted infections. Dr. Taylor added that it’s not just stigma and shame that keep people from treatment — many patients do not realize they are infected.

In my first week of 4, the Grey’s Anatomy bunch swarmed my half of a hospital room and gayly announced, you do not have HIV, Hepatitis C, or any STD/STIs. Puzzled look on my face, “when am I getting out of here?”

Dropped From Health Insurance Without Warning: Was It Legal? , Julie Appleby, KHN

Those who qualify for a subsidy due to income being less than 400% of the federal poverty level (roughly $50,000 for an individual) have a 90-day grace period to make payment after missing a payment. The law requires insurers to notify those policyholders they have fallen behind and face cancellation. If a payment is made in full before the end of the 90-day grace period, they are reinstated. If not they are canceled and medical costs incurred in the second and third months of the grace period fall on the consumer.

This policy keeps federal subsidy dollars flowing to insurers during the grace period, even if a consumer has a financial wobble.

It’s different for people who are a part of the ACA; but, their income is above 400% and do not qualify for a subsidy. They are subject to state laws and they can be dropped much more abruptly. Most states have a 30 day Grace Period for payment; however, Prior Notification law differs state to state.

Run75441 (Bill H)

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“While Considering Medicare For All: Policies For Making Health Care In The United States Better”

Robert Kocher and Donald M. BerwickWhile Considering Medicare For All: Policies For Making Health Care In The United States Better,” Health Affairs

Dr. Donald Berwick is the former Director of Medicare and Medicaid who talked about waste in Medicare and Doctors knowing such waste exists.

“It is unlikely that the United States will move quickly to a full publicly financed health insurance when Congress next considers health policy after the 2020 presidential election. Despite its theoretical advantages, passage of Medicare for All would require a massive political battle to make feasible the shift from private to public funding, to develop enough public trust to expand an entitlement program for all Americans, and to mitigate the disruption for many of substituting public insurance for familiar, existing health insurance policies. The transition will take time.”

Improving Affordability

Donald Berwick’s direction on Medicare was this: While US health care can and should be made more affordable by attacking waste, innovating in delivery system design, and improving productivity, these mechanisms are unlikely to achieve affordability quickly. He comes back with other comments which can be quicker in implementing.

• Lower the cost of health insurance for more Americans: Two types of financial assistance were implemented in the form of premium and cost-sharing subsidies. Sliding-scale premium subsidies reduced the monthly cost of insurance substantially when they phase in for people with incomes at 133 percent of the federal poverty level up till 300% FPL and phased out at 400 percent of poverty. 400% of income was $100,400 for a family of four in 2019. With an average silver-level insurance plan, the costs for healthcare insurance were $15,855 or 16 percent of income. It is recommended, no American should spend more than 10 percent of income on insurance premiums.

Cost-sharing subsidies were available to those with incomes up to 250% of poverty, average deductibles have risen to $3,000, and total out-of-pocket costs are capped at $7,900. The deductibles and out-of-pockets was done so as to give patients some skin-in-the-game and not abuse insurance. “Skin-in-the-game,” are regressive actions which disproportionately penalize people with chronic diseases. The authors recommend eliminating all cost sharing for people with incomes below 250% of poverty. For people with incomes from 251 percent to 1,000% of poverty, the authors suggest a sliding-scale of subsidies similar to the current program. Instead of annual appropriations, we would make these subsidies mandatory expenditures to replace annual appropriations and prevent an Executive Branch from using the funding of these benefits as a political weapon.

• Reduce insurance premium growth rates by limiting hospital prices. As I wrote in Again, Healthcare Cost Drivers Pharma, Doctors, and Hospitals, the biggest driver of healthcare cost is simply “pricing” increases reflected in hospitals and pharmaceuticals. These increases are reflected in insurance premiums. As the authors also point out, the biggest driver of premium increases has been in hospital price increases which have risen 42% between 2007 to 2014 and far greater than physician prices.

The ACO strategy has allowed hospitals to exploit the market through consolidation thereby eliminating competition to raise prices and enabling the employment of specialist doctors, making them “must haves” in insurance networks. As planned, the consolidation should have generated administrative cost synergy and quality benefits instead of enabling healthcare to consolidate and control prices. The authors believe no hospital should be able to charge prices that equal more than Medicare prices plus 20 percent, which is far less than many charge today (plus 89% on average) also far, far less than the 200 to 240% for hospitals in Michigan for catastrophic automobile accidents recently signed into law. The authors claim the plus 20% is enough revenue to offset Medicaid underpayments and provide incentive to be more productive. Indexing hospital prices to the Consumer Price Index rather than medical inflation, hospitals are not perversely rewarded for lower levels of productivity improvement than the rest of the economy. It is recommended, hospitals with greater than 40% market share in a given area would be required to contract with all health plans so that they cannot limit choice and competition.

• Make medications more affordable. As I noted in “ Again, Healthcare Cost Drivers Pharma, Doctors, and Hospitals,” from 1996 to 2013 in one JAMA study, healthcare costs increased by ~$1 trillion of which 50% was due solely to pricing increases. The big issue is the change in pricing for in and out patient hospital stays/care and pharmaceuticals. Hospital/clinic consolidations leads to the former even though insurance has been fighting for a reduction in stays. Pharmaceutical has instituted new pricing strategies which we have all read about in the news. Old drugs such as Humalog, Vimovo, and the infamous EpiPens as well as others are now vastly more expensive. This study points to pricing for pharma and service as one of the issues.

The authors recommend; a ban on rebates to all insurance markets and not just Medicare; reducing the period of market exclusivity for biologic drugs from 13 years to 7 years to enable generic competition sooner since biologic drugs are the most expensive drugs accounting for 70 percent of spending growth from 2010 to 2015; and adopting the Trump administration’s proposed international market basket pricing approach to set the upper limit for drug prices.

Improving Access

Improve the risk pool of people buying coverage and make Medicaid more universal.

• Create larger, lower-cost, healthier risk pools to reduce premiums. Reimpose the Individual Mandate to create larger, lower-cost, and healthier risk pools thereby reducing premiums. Since subsidies would be more generous, the penalty for not buying insurance would be larger. Short-term three-year plans would be eliminated. Reinstate the coverage of essential health benefits in all plans.

• Expand the use of reinsurance. Reinsurance lowers premiums by reimbursing plans for medical expenses for the most expensive patients These expenses do not have to be offset by premium increases from healthier patients.

• Improve Medicaid access. Medicaid provides comprehensive insurance for 74 million Americans and in some states, coverage is dropping as a result of work requirements besides other barriers to enrollment and reenrollment. The authors would eliminate Medicaid cost sharing as even small amounts of cost sharing can reduce the use of necessary services and increase wait times for enrolling in Medicaid coverage after losing commercial insurance. We would encourage the 14 states that have not expanded Medicaid to accept federal funds to expand their programs and urge the administration to accept waivers from these states, with the exception of work requirements, cost sharing, or other policies that undercut the core mission of Medicaid.

Improve Health Care Quality

The provisions in the ACA were designed to switch “volume” (fee for service) to “value” (getting paid for better outcomes). Accountable care organizations and bundled payments were two such innovations put in place to do such. They appear to have had mild and directionally desirable impact on both quality and cost. There is still more to learn.

The Institute of Medicine has categorized six defects in the quality of care resulting in excess cost. Problems in patient safety, unscientific variations in care leading to ineffective treatment, lack of patient-focus, unwarranted delays due to poor system designs, excessive prices due to lack of transparency and open competition, and fraud all of which lead to wasted resource, bad patient outcomes, and decreased value. The switch from volume to value will alleviate these defects.

The authors endorse the creations of the Center for Medicare and Medicaid Innovation to sponsor tests of new payment models and delivery system designs such as home and community-based alternatives to hospitalization, telemedicine, and the integration of behavioral health into the care mainstream. Renewed efforts to improve patient safety through innovations in training, equipment, and job roles.

Stakeholders have become enthusiastic in spending health care dollars to mitigate the power of “social determinants of health” such as housing, food availability, exercise patterns, precursors of substance abuse, early childhood trauma, and more. The authors strongly favor action and funding in that direction.

Other Issues

• Reform medical malpractice policy. Eliminate the excuse medical malpractice necessitates wasteful extra tests and treatments encouraging doctors to adopt risk-based payment models and more parsimonious approaches to care. I do have a problem with this as many states have put in place limits to malpractice. The authors have suggested a safe-harbor when doctors adhere to clinical guidelines and evidence-based care. Is malpractice a big issue? Public Citizen’s “ The Medical Malpractice Scapegoat;” details the data from 2015, (most recent full year for available data) the medical malpractice payments on behalf of doctors amounted to about 0.2 percent of costs for hospital and physician services and about 0.1 percent of all healthcare costs. The number of payments on behalf of doctors in 2015 was the lowest on record and is lower than what it was during Clinton or Bush.

• Protect Americans from surprise bills. The authors would require all doctors who provide care at in-network hospitals or outpatient facilities to bill patients at average in-network prices.

The authors believe this portfolio represents a set of policies that could be supported at least somewhat on a bipartisan basis and believe are likely to be effective and in the short term more politically viable than Medicare for All.

Run75441 (Bill H)

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Pfizer, Embrel, and Alzheimer’s

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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“Can You Patent the Sun?”

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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A Woman’s Right to Safe Healthcare Outcomes

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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