Only Trump Can Go To Single-Payer

There is an old Vulcan proverb saying that only Nixon could go to China. Only a man who used to work for Joseph McCarthy could set America on a path to better relations with a virulently Communist country. A few years after Nixon went to China, Menachem Begin, the Israeli Prime Minister who represented people believing that the state of Israel should stretch from the Nile to the Euphrates, gave Egypt back all the lands conquered in a recent war and made a lasting peace with Israel’s largest enemy. They said back then that only Begin could make peace with the Arabs.

Today, I want to submit to you that only Trump can make single-payer health care happen in this country. Only a billionaire, surrounded by a cabinet of billionaires, representing a party partial to billionaires, can make that hazardous 180 degrees political turn and better the lives of the American people, and perhaps the entire world as a result. Oh, I know it’s too soon to make this observation, but note that both Mr. Nixon and Mr. Begin were deeply resented (to put it mildly) in their times, by the same type of people who find Mr. Trump distasteful today. The liberal intelligentsia back then did not have the bona fides required to cross the political chasm between one nation and its ideological enemies, or as real as death immediate foes. The liberal intelligentsia today lost all credibility in this country when it comes to providing a universal solution to our health care woes.

Free health care (and free college) are not solutions. These are rabble rousing slogans to gin up the vote, slogans that end up in overflowing trashcans left in ballrooms littered with red white and blue balloons after everybody goes home to get some sleep before the next round of calls to solicit funds from wealthy donors for the next campaign. Providing proper medical care to the American people is a monumental enterprise that engages tens of millions of workers from all walks of life, every second of every day, in every square mile of habitable land, littered with the hopes and fears of hundreds of millions of invisible men, women and children who call this great country their home. This is not something that can be made free. Nothing is free in our times, not even sunshine and fresh air.

For the jaded, the cynically inclined, and those who are simply too afraid to jump off this cliff, and therefore argue that single-payer is not politically feasible, I have a simple question. Did you all think a couple of years ago, that a President Trump is politically feasible?  Okay then. Here is what I believe could be a relatively plausible scenario enabling this one-of-a-kind administration to use its unconventional political capital (if you can even call it that) to get us on the road to making health care great again, greater than ever before.

Step 1: Disaster

The current system, held together with string and duct tape must undergo a seismic shock, preferably a moderate shock and one that does not involve war and famine. The way things look now, the most likely implosion will be the Obamacare individual market. If the Trump administration holds back ransom money from insurance companies (a.k.a. CSRs), or engages in other mischievous behavior, and the individual mandate is not enforced, we may very well have a minor disaster on our hands. In addition, the President’s Commission on Combating Drug Addiction and the Opioid Crisis is requesting that the President declare the opioid epidemic a national public health emergency. Put these two together and you see how lots of people are, or will shortly be, in dire need of medical services not currently available to them via existing “insurance” channels.

Step 2: Relief

The opioid crisis will need much more than providing care for its current victims, but we will need a coordinated effort to provide all necessary medical services to people addicted to opioids who are uninsured, or whose insurer is refusing to pay for the extensive programs needed for recovery. People who were able to afford insurance under Obamacare without, or with minimal, subsidies and are now left hanging to dry will also need a solution, and if they are sick, they will need immediate relief. This would be the perfect time to cut through the red tape and institute the Disaster Relief and Emergency Access to Medicare (DREAM) program. The DREAM will open Medicare to the victims of Obamacare and the victims of the opioid epidemic. This will be put in place as a temporary disaster response program, subject to extension of course, until a more permanent solution can be found. I doubt too many people in Congress could vote against such measure.

Step 3: The DREAM

No matter how short lived, all government programs including temporary ones need rules and regulations to execute now, and to be replicated in future emergencies as needed. Besides, any respectable bill needs more than just a title. How do we define opioid addiction? How do we define Obamacare victim? How do they sign up? What do they get? How much will it cost?

Opioid Crisis

  • Congress will appropriate $45 billion for this program for a period of five years to cover administrative costs, medical costs and program analysis costs.
  • Emergency funding will be provided to Federally Qualified Community Centers (FQHCs) to set up a process for opioid addiction screening. FQHCs are non-profit clinics, funded by the Federal government to serve low income populations regardless of ability to pay. All physicians and staff are salaried. The funding will be administered by the Health Resources and Services Administration (HRSA) and defined by the Secretary of Health and Human Services (HHS).
  • Any American citizen or lawful permanent resident will be eligible to access any FQHC and undergo opioid screening as specified by the Secretary at no cost. Individuals eligible for relief, based solely on clinical criteria, will need to provide information about their insurance status. Upon receipt of consent from the individual or legal guardian if the screened individual is a minor, eligibility results and insurance information will be sent from the FQHC to CMS for enrollment in the DREAM program.
  • If the eligible person (EP) is currently covered by commercial insurance, CMS will contact the EP’s insurance plan and require that the plan contacts the EP or legal guardian and obtains proper consent to transfer the EP’s coverage to the DREAM program. Following EP consent, Medicare will become the primary payer for the EP. Medicare at its sole discretion may discontinue eligibility for the EP and the commercial plan must reinstate coverage for the EP at that time. All subsidies paid by the Federal government to the insurance plan, if any, will be paid into the Medicare trust fund for the duration of DREAM participation.
  • The EP will pay to Medicare premiums equal to the last monthly amount the EP paid to the commercial plan. Medicare will cover all opioid related services with zero deductible and zero copay. For other services the EP deductible and copays will be equal to those of traditional Medicare beneficiaries (parts A, B and D). Medicare will end DREAM eligibility for an EP who missed 3 consecutive monthly payments.
  • If the EP is insured, or eligible to be insured, through Medicaid or any other public program, Medicaid or any other public program, will transfer into the Medicare trust fund estimated monthly premiums as calculated by the Secretary for the duration of DREAM participation. Medicaid will become the secondary payer for EPs previously enrolled, or eligible to be enrolled, in Medicaid.
  • If the EP is uninsured and not eligible for public insurance, the EP will be enrolled in Medicare (parts A, B and D), under the same terms as beneficiaries 65 years or older for the duration of DREAM eligibility, except that all opioid related services will be covered with zero deductible and zero copay.

Obamacare Crisis

  • Congress will appropriate $45 million for this program for a period of five years to cover program administration, evaluation and analysis. All other program costs, if any, will be absorbed by CMS budgets.
  • Any American citizen or lawful permanent resident who is not offered employer sponsored insurance, and is not eligible for Medicaid or another public insurance plan, and is not eligible for Federal subsidies on the Obamacare exchanges equal to at least 50% of total costs of the current benchmark plan, or resides in a county where no Obamacare plans are available on the exchange on the first day of the open enrollment period, will be eligible to enroll in Medicare parts A, B and D, at an annual rate of average Medicare spending per beneficiary (MSPB), adjusted for EP age.
  • The Secretary shall publish a list of DREAM premiums for three age bands, 0-21, 22-45, 46-64, no later than one month before the first day of open enrollment for the Obamacare exchanges. All DREAM rates will be assessed and billed for each individual EP. No family rates will be available and no Federal subsidies will be given to DREAM enrollees.
  • The EP, or a legal guardian if the EP is a minor, is responsible for premium payments to Medicare. EP deductible and copays will be equal to those of traditional Medicare beneficiaries (parts A, B and D). Medicare will end DREAM eligibility for an EP who missed 3 consecutive monthly payments.
  • For each program year the Secretary shall conduct and publish comparative analyses of Federal spending on Obamacare exchange enrollees and DREAM program enrollees to inform Congress and the public on the merits of each program.

Step 4: Consequences

See? Wasn’t that bad now, was it? Defining the program is relatively easy and the above is just an abbreviated example. Other details will need to be added, removed or changed, but the main idea here is to open Medicare in the short term to people who are hurting and are underserved by the commercial health insurance markets. There will of course be consequences. First, the Obamacare exchanges will most likely go bust, and we will have to expand the DREAM to allow enrollment of people who will bring their subsidies with them. Second, employers may decide to fund Medicare premiums instead of dealing with health insurance in house. Third, the folks who don’t qualify for the DREAM program may start chomping at the bit, seeing how DREAMers get to choose pretty much everything without breaking the bank. 

Yes, yes, I know. I’m being too clever by half, but surely someone who professes to be the voice of the forgotten men and women, could see his way clear to make this happen. It will, after all, lead to a complete repeal and replace of Obamacare. And for all timid liberals enamored with the poetry inscribed at the feet of Lady Liberty, let’s help the President erect a statue of liberty at the gates to Medicare.

Health Care and Java

Your Best Health Care: Health Care and Java

Health Care and Java

How do you
feel about coffee–that java that makes you jump, that black elixir of silky
goodness, the cuppa joe for the morning wakeup call? Well, believe it or not,
adding coffee to your daily diet can help with your health. If you already
drink it, you’ll be glad to know that in addition to providing a boost to get
you going, and the taste that may make you happy, coffee has some remarkable
powers to help your body and brain.
According
to this website,
http://coffeeandhealth.org/ , a new
study examined the relationships between coffee (total, caffeinated or
decaffeinated) and tea consumption and risk of melanoma in the European
Prospective Investigation into Cancer and Nutrition (EPIC). EPIC is a
multi-centre prospective study that enrolled over 500,000 participants aged
25-70 years from ten European countries in 1992-2000.
Consumption
of caffeinated coffee was inversely (i.e. favorably) associated with melanoma
risk among versus non-consumers, but not among women. There were no
statistically significant associations between consumption of decaffeinated
coffee or tea and the risk of melanoma among both men and women. The authors
suggest further investigations are warranted to confirm their findings and
clarify the possible role of caffeine and other coffee compounds in reducing
the risk of melanoma.
According
to the Harvard School of Public Health, more than half of American adults drink
coffee every day. Recent scientific studies suggest moderate consumption may
help reduce some disease risks. These studies are observational, meaning that
researchers draw conclusions based on differences between the number of disease
cases in coffee drinkers versus non-drinkers. More information is located at
this site: https://www.hsph.harvard.edu/news/multimedia-article/benefits/
.
Not only
is this information good news, but this article by blogger Jenn Miller shows
that there are many health care pluses for coffee consumption:  https://www.jenreviews.com/coffee/
.
You may
wonder when you see various reports over the past few years about the efficacy
of drinking coffee and its health affects on you. The verdict is thumbs up,
according to CNN, with study after study extolling the merits of three to five
cups of black coffee a day in reducing risk for everything from melanoma to
heart disease, multiple sclerosis, type 2 diabetes, Parkinson’s disease, liver
disease, prostate cancer, Alzheimer’s, computer-related back pain and more.
To stay
completely healthy with your coffee consumption, you’ll want to avoid packing
it with calorie laden creams, sugars and flavors, per the CNN article. And be
aware that a cup of coffee in these studies is only 8 ounces; the standard
“grande” cup at the coffee shop is double that at 16 ounces.  And how you brew it has health consequences.
Unlike filter coffee makers, the French press, Turkish coffee or the boiled
coffee popular in Scandinavian countries fail to catch a compound called
cafestol in the oily part of coffee that can increase your bad cholesterol or
LDL.
Finally,
people with sleep issues or uncontrolled diabetes should check with a doctor
before adding caffeine to their diets, as should pregnant women, as there is
some concern about caffeine’s effect on fetal growth and miscarriage. And some
of the latest research seems to say that our genes may be responsible for how
we react to coffee, explaining why some of us need several cups to get a boost
while others get the jitters on only one. For much more detailed information on
this subject, visit this website: http://www.cnn.com/2015/08/14/health/coffee-health/
.
Caffeine, the most widely consumed psychoactive
substance in the world, is the best known ingredient of coffee, according to
Warrior Coffee. Its beneficial effects on the human body have been researched quite
well, but coffee as a whole is a complex beverage with a thousand different
substances. Some studies argue that decaf and caffeinated coffee may have the
same health effects and suggest that it’s not the caffeine that is responsible
for most of coffee’s health benefits. This company has put together a list
of  Pro’s and Con’s about coffee drinking
and is well worth reading to give you both sides of the story:
https://www.warriorcoffee.com/news/2/12-health-benefits-and-6-disadvantages-of-coffee-smashing-it
.
For those on the healthy side of coffee consumption, this
website, https://www.healthambition.com/negative-effects-of-coffee/
, has some negative aspects listed about this liquid:
In small, occasional cups there is
possibly a case to be made for some benefits to coffee. If it’s fresh,
high-quality and ideally organic (regular coffee is one of the most
pesticide-intensive crops in the world) then a raft of studies have shown that
it can improve alertness and long term it may reduce the risk of developing
Parkinson’s disease, gallstones, kidney stones and liver cirrhosis for heavy
drinkers.
Conversely,
in the longer term it has been associated with an increased risk of high
cholesterol, heart disease, and osteoporosis. Good-quality ground coffee is a
source of antioxidants like chlorogenic acid that may help with weight loss and
Green Coffee Bean Extract, particularly high in this antioxidant, are the
latest popular supplement for body fat reduction. While there is evidence one
way and another about drinking coffee, a case can be made for either side of
the java wars.
Is coffee associated with the risk of death from all
causes? According to a report in the New York Times, there have been two
meta-analyses published within the last year or so. The first reviewed 20
studies, including almost a million people, and the second included 17 studies
containing more than a million people. Both found that drinking coffee was
associated with a significantly reduced chance of death. There’s possibly no
other product that has this much positive epidemiologic evidence going for it.
For more details on this product, read this article: https://www.nytimes.com/2015/05/12/upshot/more-consensus-on-coffees-benefits-than-you-might-think.html?_r=0
.
But, you
need to be careful about how you drink your coffee. According to the Atlantic
Monthly magazine a few years ago,
there were no major differences in risk reduction between
regular and decaf coffee suggests there’s something in it, aside from its
caffeine content, that could be contributing to these observed benefits. It
also demonstrates that caffeine was in no way mitigating coffee’s therapeutic
effects.
Of course, what you choose to add to coffee can just as
easily negate the benefits — various sugar-sweetened beverages were all
significantly associated with an increased risk of diabetes. A learned taste
for cream and sugar (made all the more enticing when they’re designed to smell
like seasonal celebrations) is likely one of the reasons why we associate
coffee more with decadence than prudence. More details are available at this
site: https://www.theatlantic.com/health/archive/2012/11/the-case-for-drinking-as-much-coffee-as-you-like/265693/
So, should you drink that little black cup of java that
so eagerly calls your name every day, or give it up for what may be considered
healthier beverages like water, fruit juices, or other non-caffeinated types of
liquid? That is a personal choice, and one that needs to be evaluated by you
and your family doctor if you have mitigating health circumstances.

"Hey Alex, I Don’t Feel Well. Find A Physician Near Me." Hospital Marketer, Is Your Website Optimized for Voice Search?

How does this grab you? Thirty-eight percent of all internet
searches are now by voice using a digital assistant like Siri, Alexa, Echo, and others on a smartphone or home voice internet
connected device. Additionally, most voices activated
searches are using the term “near me” sometimes combined with the term “near me
today.” 

Putting it another way, will the healthcare consumer and
potential patient voice searching for a physician, find the hospital via your “Find-A-Physician”
portal on your website?

I ask the question about finding a physician because I don’t think people are going
to voice-search the hospital, except
maybe to get directions. And the other reason is that no matter the payment system,
the hospital still needs a physician’s order for any diagnostic testing or
treatment.

What to do?

Now that I have your attention and it very well could be an
OMG moment, with now I have something else to worry about, optimizing the hospital
or health system website is possible in short order. The following seven steps should
enable you to start optimizing for voice searches. 

1.      
Ditch the old fashion search keywords like hospital
Plainfield or Cardiovascular Service Line. Nobody talks like that conversationally.
Searches are in the natural language of
the person. 

2.      
Move to long-tail keywords. Long-tail keywords
generally run from three to five words. Long-tail keywords are important due to
the preference of digital assistants to use natural language for processing
requests. If you use a digital assistant for shopping, think about how you speak to Siri or Alex for example, you speak conversationally
and naturally to the devices whether you realize it or not. 

3.      
Exploit the power of near me searches. Voice searches
are local. All healthcare is local. That’s the connection for you. The
healthcare consumer isn’t looking for an exotic specialty; they are searching “near me” for the solution to
their problem. 

4.      
Make sure it’s
easy for bots and spiders to crawl your site and know what the hospital business
is.
Make sure you submit your sitemap to
Google and Bing. Start incorporating microdata, schema, rich snippets and so
on. These little pieces of code give the search engines even more information
about what your business is all about. 

5.      
You also want to
make sure that your online business directories (aka citation sites) are
accurate as well. For example, if one address is
on Yelp, and another is on Citysearch, the search engines won’t know
which address is the correct one and will be less likely to pull your hospital
up in voice search results. 

6.      
Take a look at
your analytics. Google’s Search Console reports show you what queries are
bringing people to your site. Now that being said, you can’t tell if the search
query came from voice search or the good old-fashioned way. You can get some
good ideas based on how people are finding you right now. 

7.      
Since most voice
searches take place on mobile devices,
you must have a mobile-friendly site. If a person does a voice search, goes to
your site and has a bad experience, it’s over. This
not only impacts that individual searcher
but a high bounce rate because your site is difficult to use on a smartphone
can also negatively affect your rankings on Google.

“Hey Siri, find a hospital near me that has the best satisfaction
and experience ratings.”  
Michael is a
healthcare business, marketing, communications strategist and
thought-leader.  As an internationally followed healthcare strategy
blogger, his blog, Healthcare Marketing Matters is read in  52 countries
and listed on the 
100 Top Healthcare
Marketing Blogs, and Websites
 ranked
at No. 3 on the list by Feedspot.com. Michael is a Life Fellow, American
College of Healthcare Executives, and a Professional Certified Marketer,
American Marketing Association. An expert
in healthcare marketing strategy, digital marketing & social media, Michael
is in the top 10 percent of social media experts nationwide and is considered
an established influencer. For inquiries regarding strategic consulting
engagements, call Michael at 815-351-0671. Opinions expressed are my
own.

Curing Type 1 Diabetes

Type 1 Diabetes is an autoimmune disease where the pancreas
cease producing insulin, which is essential for the body to process hormones
for regulating bodily fuel or sugar. Without insulin Type 1
Diabetics will die. At present there is no cure for diabetes, but the
administration of insulin allows most diabetics to function normally. However,
the disease is fraught with all kinds of comorbidities or side affects such as
failing vision, circulatory problems, nerve damage, and increased risk of infections
frequently leading to amputations. Diabetics often end up on kidney dialysis,
which reduces life expectancy and increases the risk of infections even more. According to the Centers for Disease Control and Prevention (CDC) 50% of patients with chronic kidney disease are diabetic.



Approaches to Curing Diabetes

Scientific studies for potential cures for Type 1-Diabetes
include:
  1.  Cellular manipulation
    by removing the attacking mutation to restore normal pancreatic
    function
  2. Possible vaccines to prevent diabetes
  3. Increased public
    health surveillance to screen for those at risk of diabetes before they lose
    their pancreatic function

 All approaches are
focused on preventing damage and intervening before diabetes has ravaged the
pancreas. Once a person ceases to create insulin the only way to change that is
through a transplant, which must come from a deceased donor, as a pancreas is
an essential organ.

Current Research to Detect Those at Higher Risk for Diabetes
The T-1 study through Benaroya Research Institute examines tissue samples from people with increased risk of diabetes, which is based on a screen for the presence of islet autoantiboides and the genetic risk for diabetes. Through the application of scientific methods Dr. Marika Bogdani, MD, PhD and her research team at BRI have identified cellular behaviors indicating which individual human samples likely represent early and advanced stages of damage in insulin making tissue inside the pancreas. Her team is researching this cellular behavior with the goal of blocking the agent which damages the pancreas in high-risk individuals. Dr. Bogdani’s research shows that people with Type 1 Diabetes have a modified islet cell which produces more Hvaluronan (HA). Her research recently showed these cells are modified earlier before the onset of diabetes in individuals whom have these hostile islet autoantibodies. The very presence of these antibodies is an indication of cellar damage for insulin producing cells. In scientific terms, possessing two or more of these antibodies and the presence of the observed genotype is an indication of increased risk for developing Type 1 Diabetes. There are stages of diabetes before someone requires insulin and the first stage of the disease is the presence of these antibodies. The second stage is called dysglycemia and the third stage is insulin dependency.
Next Steps in Research and Clinical Application

Dr. Bogdani’s group is now studying how the timing of this cellular modification impacts insulin cell function and survival, which will illuminate how to effectively minimize pancreatic damage. Current study of islet cells will also reveal which cells, such as endocrine or mesenchymal, are creating the HA growth and what causes the cells to make HA. This will lead to further refinements in potential clinical interventions.  

Current Clinical Applications at the Patient Level
Scientifically there is enough information to be able assess
individual risk for diabetes through blood samples. The increased presence of
HA in the islet cells is an indication of Type 1 Diabetes at a very early stage
and the Trialnet study screens for these antibodies. For more information on
participating in the Trialnet study go to Benaroya Research Institute’s site:
Next Steps in A Public Health Intervention
 Primary healthcare
should include diabetic screening tests, not just for adults, but for children
as well, as Type 1-Diabetes primarily strikes children and young adults. Screenings
could be done by individual clinicians during the annual wellness exams.

 

A more comprehensive approach would be to screen all
school-age children. Since many diabetics do not realize they have the disease
until quite late in its gestation, this would provide greater population
surveillance of this costly disease. The earlier a person is screened for
diabetes the less damage the antibodies can cause to pancreatic function. It is
possible to intervene while an individual still has pancreatic function.
Earlier diagnosis in disease progression is best.

The author rode from Washington State to Napa,
California in eight days, to raise awareness about the plight of diabetics, and raised $5,000 for the Benaroya Research Institute, to fund medical research to cure Type 1 Diabetes. She is the author of a guidebook to the U.S.
healthcare system, which was published by Rowman and Littlefield in 2013.
 https://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972
This column has been continuously published since November 2007, the year her brother, Russell died from complications of Type 1 Diabetes.
This is the healthpolicymaven signing off, encouraging you not to sign blanket releases, but do specify that for which you consent and that for which you do not before you undergo a medical procedure.

Johnson and Johnson’s Latest Ethical Misadventures: Settled Kickback Allegations, Reportedly Concealed Knowledge of Adverse Effects of a "Sacred Cow" Product


Giant pharmaceutical/ biotechnology/ device company Johnson & Johnson has its famous “credo” which starts with

We believe our first responsibility is to the doctors, nurses and
patients, to mothers and fathers and all others who use our products and
services.  In meeting their needs everything we do must be of high quality..

Nonetheless, the company has a long history of ethical misadventures (look here, and see appendix below).  Now late in 2018,  we note two more Johnson & Johnson misadventures. In chronological order,

$360 Million Settlement of Allegations of Kickbacks to Medicare/ Medicaid Patients to Support Use of Extremely Expensive Drug

The story, per the New York Times, was that Actelion, a drug maker purchased by Johnson & Johnson in 2017, in 2014-2015 had

raised the price of its main drug, Tracleer, by nearly 30 times the rate of inflation. Tracleer, which is prescribed to treat pulmonary arterial hypertension, sells in pharmacies for an average cash price of about $14,500 for 60 tablets, according to the website GoodRx.

But to facilitate charging such high prices, pharmaceutical companies

often help patients pay their out-of-pocket costs through coupons or other financial assistance. These payments are not just about benevolence — they also help blunt the outrage over rising drug prices by limiting how much patients have to pay. Insurers then cover most of the cost.

But federal anti-kickback laws prohibit companies from giving such financial assistance to Medicare and Medicaid beneficiaries because doing so is considered an inducement to buy their drugs. For years, drug makers have skirted those laws by instead donating to nonprofit charities, which then give the money to Medicare patients. Such arrangements are legal as long as there is no direct coordination between the pharmaceutical company and the nonprofit organization.

However,

Federal prosecutors said Actelion violated the law by collecting detailed data in 2014 and 2015 about the patients receiving help from a nonprofit, the Caring Voice Coalition, and using the data to budget for future donations. As a result, Actelion ensured that the money it donated would be used only to assist patients who used its drugs, and not competing companies’ treatments for the pulmonary condition.

Prosecutors said Actelion kept up the practice even after the charity itself warned the company against it.

Actelion also steered Medicare patients to the Caring Voice Coalition who would have otherwise qualified financially for the company’s free drug program. By directing them to the nonprofit, the company avoided having to provide the drug to eligible patients and left Medicare to cover the cost instead, prosecutors said.

So,

Actelion Pharmaceuticals has agreed to a $360 million settlement stemming from an investigation into whether the company illegally funneled kickbacks through a patient-assistance charity, federal prosecutors said Thursday.

But keep in mind that Actelion is now a Johnson & Johnson subsidiary, and by buying it, Johnson & Johnson bought its financial, and ethical and legal liabilities.. So ultimately it will be Johnson & Johnson which pays the settlement.

Johnson & Johnson Alleged to Have Concealed Knowledge that its Baby Powder Contains Asbestos

The first reporting on this story was a lengthy investigative report from Reuters published December 14, 2018, based on newly released documents produced during a variety of lawsuits.  The report stated

that from at least 1971 to the early 2000s, the company’s raw talc and finished powders sometimes tested positive for small amounts of asbestos, and that company executives, mine managers, scientists, doctors and lawyers fretted over the problem and how to address it while failing to disclose it to regulators or the public.

The documents also depict successful efforts to influence U.S. regulators’ plans to limit asbestos in cosmetic talc products and scientific research on the health effects of talc.

Note that since the 1970s, exposure to asbestos has been recognized as an
important health hazard.  In 1972, the US agency OSHA limited
occupational exposure to asbestos.  Also,

The World Health Organization and other authorities recognize no safe level of exposure to asbestos.

Johnson & Johnson has been sued by

11,700 plaintiffs now claiming that the company’s talc caused their cancers — including thousands of women with ovarian cancer.

After three major jury verdicts that found Johnson & Johnson liable for cancers caused by asbestos in its baby power,

J&J
has said it will appeal the recent verdicts against it. It has
maintained in public statements that its talc is safe, as shown for
years by the best tests available, and that the information it has been
required to divulge in recent litigation shows the care the company
takes to ensure its products are asbestos-free. It has blamed its losses
on juror confusion, ‘junk’ science, unfair court rules and overzealous
lawyers looking for a fresh pool of asbestos plaintiffs

However, there now seems to be substantial evidence that the company’s public posturing is a smokescreen. While in the past Johnson & Johnson internal documents about its management decision making related to talc and asbestos were used in litigation,

Many were shielded from public view by court orders that allowed J&J to turn over thousands of documents it designated as confidential. [But] Much of their contents is reported here for the first time.

These showed,

The earliest mentions of tainted J&J talc that Reuters found come from 1957 and 1958 reports by a consulting lab. They describe contaminants in talc from J&J’s Italian supplier as fibrous and ‘acicular,’ or needle-like, tremolite. That’s one of the six minerals that in their naturally occurring fibrous form are classified as asbestos.

At various times from then into the early 2000s, reports by scientists at J&J, outside labs and J&J’s supplier yielded similar findings. The reports identify contaminants in talc and finished powder products as asbestos or describe them in terms typically applied to asbestos, such as ‘fiberform’ and ‘rods.’

In 1976, as the U.S. Food and Drug Administration (FDA) was weighing limits on asbestos in cosmetic talc products, J&J assured the regulator that no asbestos was ‘detected in any sample’ of talc produced between December 1972 and October 1973. It didn’t tell the agency that at least three tests by three different labs from 1972 to 1975 had found asbestos in its talc – in one case at levels reported as ‘rather high.’

The article shows that the company repeatedly found evidence that asbestos was present in the raw talc that went into its baby powder, first in 1957, and could be found at times in samples of the finished product since 1971.  Since the 1970s, Johnson & Johnson managers realized that the asbestos was a problem.  For example,

J&J research director DeWitt Petterson visited the company’s Vermont mining operation. ‘Occasionally, sub-trace quantities of tremolite or actinolite are identifiable,’ he wrote in an April 1973 report on the visit. ‘And these might be classified as asbestos fiber.’

J&J should ‘protect our powder franchise’ by eliminating as many tiny fibers that can be inhaled in airborne talc dust as possible, Petterson wrote. He warned, however, that ‘no final product will ever be made which will be totally free from respirable particles.’ Introducing a cornstarch version of Baby Powder, he noted, ‘is obviously another answer.’

Slightly later on December 14, 2018, the New York Times published its own story on asbestos in Johnson & Johnson talcum powder.  It corroborated the Reuters report while adding informative detail.  It started with:

An executive at Johnson & Johnson said the main ingredient in its best-selling baby powder could potentially be contaminated by asbestos, the dangerous mineral that can cause cancer. He recommended to senior staff in 1971 that the company ‘upgrade’ its quality control of talc.

Two years later, another executive raised a red flag, saying the company should no longer assume that its talc mines were asbestos-free. The powder, he said, sometimes contained materials that “might be classified as asbestos fiber.”

The carcinogen, which often appears underground near talc, has been a concern inside the company for decades. In hundreds of pages of memos, executives worried about a potential government ban of talc, the safety of the product and a public backlash over Johnson’s Baby Powder, a brand built on a reputation for trustworthiness and health.

Executives proposed new testing procedures or replacing talc outright, while trying to discredit research suggesting that the powder could be contaminated with asbestos, according to corporate documents unearthed by litigation, government records obtained by The New York Times through the Freedom of Information Act, and interviews with scientists and lawyers.

In one instance, Johnson & Johnson demanded that the government block unfavorable findings from being made public. An executive ultimately won assurances from an official at the Food and Drug Administration that the findings would be issued only ‘over my dead body,’ a memo summarizing the meeting said.

Thus, despite these warnings of asbestos in talcum powder, Johnson & Johnson continued to sell it.  There is certainly now strong reason to suspect that for decades Johnson & Johnson management has been denying its own fears about asbestos contamination of its baby powder, and doing its best to hide evidence of its hazards, thus benefiting the corporate bottom line, but allowing continued exposure of large number of people to a potentially hazardous, even fatal product.

The Business World Tries to Shrug It Off

Responding to the Reuters and New York Times story, many business pundits stated their confidence in Johnson & Johnson as an investment.  For example, Charley Grant wrote in the Wall Street Journal,

But while investors should be wary, they needn’t panic. J&J’s strong finances and diverse revenue base are good coping mechanisms.

Wells Fargo, per CNBC, opined

the selling based purely on the outcomes of any talc litigation is likely overstated.

But does Johnson & Johnson’s management really act on its belief that
its “first responsibility is to “doctors, nurses, and patients, to
mothers and fathers?” On CNBC,  Bill George wrote,

It is not plausible that these leaders knew nearly five decades ago that their iconic baby powder caused cancer and continued to market the product. This is a company whose leaders consistently try to do the right thing, admit their mistakes, and continue to develop life-saving products that restore the health of millions of people around the world.

While the plaintiffs’ attorneys may continue to pursue their cases, I feel confident that J&J will be shown to put the interests of its customers first, and maintain its reputation for the highest integrity.

I wonder if Mr George’s confidence was boosted by his previous work as a paid speaker for Johnson & Johnson, and former chairman and CEO of Medtronic, a company which has had its own share of ethical misadventures (look here)?  In any case, some recent history calls into question Johnson & Johnson’s “reputation for the highest integrity.”

Johnson & Johnson’s Long History of Ethical Misadventures

So, recent reports suggested that Johnson & Johnson willfully acquired a company that appears to have provided kickbacks to patients in apparent violation of US law in an effort to support high drug prices.  Furthermore, Johnson& Johnson appears to have concealed considerable evidence that one of its primary products might be dangerous in order to support the sales of a “‘sacred cow,’ as one internal email put it (per the Reuters report).

These are but  the latest in a long string of misadventures by the company, as we have been documenting over years.  (Our collected posts on Johnson & Johnson are here
An updated version of their legal record since 2010 is at the end of
this post.)

Perusing the list suggests that this giant company (with about $70
billion in yearly revenue) is a poster child for bad behavior by health
care organizations.  It has faced a multitude of allegations leading to
settlements, and sometimes findings of guilt.  The charges included many instances of deceptive and unethical marketing, some that promoted drugs or devices for use in situations in which they may have had harms outweighing their benefit, some that involved concealing knowledge of their risks, and some of selling adulterated drugs or defective products. 

So the new allegations of deceptive marketing meant to conceal a hazardous product are just the latest in the series.

What is striking is that the company and its management have not faced more consequences for this sorry track record.

Although the company has paid multiple fines and made numerous monetary settlements over the years, none have been big enough to affect its immense revenues.  Furthermore, ultimately the monies used to pay them came from all Johnson & Johnson employees in the form of smaller paychecks; customers, patients and the public at large in the form of higher prices; and only to some extent by investors in the form of slightly lower profits.  Meanwhile, it appears that the company’s top managers made an awful lot of money, possibly in part as rewards for the revenues produced by the misadeventures.

Former Johnson & Johnson CEO William Weldon, upon his
retirement in 2014, was to receive a retirement package estimated to be
worth from $143 to $197 million (look here).  In 2010, his total compensation was $29 million (look here).   According to the 2012 Johnson and Johnson proxy statement,
his 2011 total compensation was greater than $26 million. As far as I
can tell, Mr Weldon never suffered any negative consequences for his
company’s sorry record, and retired a very rich man. (look here).

Current CEO Alex Gorsky received  $25 million total compensation in 2014 (look here).  More recently, the New York Times reported his 2017 total pay was $22.8 million, making him the seventh highest paid health care executive in that year, by their accounting. 

While management made so much money, very rarely has anyone at the company who was involved in authorizing, directing, or implementing any of the bad behavior had to suffer any negative consequences, therefore appearing to enjoy impunity.

So what was to deter management from embarking on further misadventures, as long as the results might be enlarging management’s personal wealth?  

This is all in line with what we have been discussing for years.  In general, we have seen many legal settlements made by health care organizations of alllegations like fraud, bribery, and kickbacks
Despite the unsavory nature of the behaviors revealed by most
settlements, which often appeared to risk patient harms, the companies
involved usually have had to pay fines that were tiny
relative to their multi-billion dollar revenues.  They companies only
seldom have had to admit responsibility, and almost never did a
settlement cause company managers and leaders to 
suffer any negative consequences for enabling, authorizing, directing or
implementing the bad behavior.

This adds to the evidence suggesting that US health care is
rigged to benefit top insiders and their cronies, and as such, is part of a
larger rigged system.  We have previously discussed how market fundamentalism (or
neoliberalism) led to deregulation, which enabled deception, fraud,
bribery, and intimidation to become standard business
practices, and allowed increasing concentration of power by large
corporations. Managerialism allowed the top leaders of these
corporations and their insider cronies to amass increasing power and
money. Everyone else, other employees, stockholders of public
corporations, customers, vendors and suppliers, and the public at large
lost out.   In health care, these changes led to an increasingly
costly system which produced increasingly bad results for patients
and the public. 

We have called for true health care
reform to derig the system. Unfortunately, despite our hopes,
perceptions of a rigged
system may not always inspire honest reform. Instead, they can
enable the rise of demagogues and wouldbe dictators who promise only
they can solve the problem.  Donald Trump cried out that only he could
fix our problems and drain our swamps.  However, at least in terms of
policing white-collar crime, particularly in health care, he seems to be
letting the swamp waters rise.  And now he seems to have had his own record of impunity (look here).  

While we thus have bigger problems to solve than the impunity of health
care leaders, let us remember the need for wholesale, real health care
reform that would make health care
leaders accountable for what their organizations do, particularly when
these organizations misbehave.

Appendix – Johnson and Johnson Legal Record since 2010

 2010
– Convictions in two different states for misleading marketing of Risperdal
– A guilty plea for misbranding Topamax

2011
– Guilty pleas to bribery in Europe  by Johnson and Johnson’s DePuy subsidiary
– A guilty plea for marketing Risperdal for unapproved uses  (see this link for all of the above)
– A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post here)

2012 
 
– Testimony in a trial of allegations of
unethical marketing of the drug Risperdal (risperidone) by the Janssen
subsidiary revealed a systemic, deceptive stealth marketing campaign
that fostered suppression of research whose results were unfavorable to
the company, ghostwriting, the use of key opinion leaders as marketers
in the guise of academics and professionals, and intimidation of
whistleblowers. After these revelations, the company abruptly settled
the case (see post here).
–  Johnson & Johnson was fined $1.1 billion by a judge in Arkansas for
deceiving patients and physicians again about Risperdal (look here).
–  Johnson & Johnson announced it would pay $181
million to resolve claims of deceptive advertising again about Risperdal
(see this post).

2013
–  Johnson &
Johnson settled case by shareholders alleging that management made
misleading statements and withheld material information about
manufacturing problems (see this post)
–  Johnson &
Johnson Janssen subsidiary pleaded guilty to a charge of misbranding
Risperdal, and settled for a total of $2.2 billion allegations that it
promoted the drug for elderly demented patients and adolescents without
an indication, and despite evidence of its harms (see this post).
 –  Johnson &
Johnson DePuy subsidiary agreed to settle with multiple plaintiffs for
$2.5 billion allegations that it sold defective mental-on-metal
artificial hip, and hid evidence of its harms .
– Johnson &
Johnsonn Janssen subsidiary was found by two juries to have concealed
harms of its drug Topamax (see this post for this and above case).
– Johnson &
Johnson Ethicon subsidiary’s Advanced Surgical Products and two of its
executives agreed to settle charges by US FDA that is sold mislabeled
products used to sterilize equipment such as endoscopes (see this post).
– Johnson &
Johnson fined by European Commission for anticompetitive practices, that
is, collusion with Novartis to delay marketing generic version of
Fentanyl (see this post).

2014 
– Johnson & Johnson DePuy subsidiary settled Oregan state charges
that it marketed the ASR XL metal-on-metal hip joint prosthesis without
disclosing its high failure rate (see this post).

2015
–  Johnson & Johnson found by jury to have concealed harms of Risperdal.
–  Johnson & Johnson Ethicon subsidiary found by jury to have concealed harms of its vaginal mesh device.
–  Johnson & Johnson McNeil subsidiary pleaded guilty to marketing adulterated Tylenol. (see this post for three items above.)

2016
– Johnson & Johnson subsidiary Aclarent settled allegations that it
sold its Stratus device for unapproved uses.  Two former executives of
that subsidiary also were found guilty of distributing misbranded and
adulterated devices (see this post

Review of Longevity Decoded


Longevity Decoded by Dr.
Stephen Schimpff is an engaging discourse on the issues facing seniors
today.  The title itself draws the reader into a personal search for ways
to age gracefully.  

And it is a tone of lightness and
good humor employed by Dr. Schimpff that immediately underscores his central
thesis for healthy aging:  a positive attitude; calm acceptance of one’s
mortality; and “living in the moment.”

In presenting a common-sense,
practical prescription for the aging process, Dr. Schimpff details medical information
– including recent medical breakthroughs – with clarity and incisiveness. 
His “seven keys” are punctuated with suggestions and tips for the senior. 
In one section, he outlines the major elements of the “Mediterranean diet”; in
another he notes ways to improve and maintain one’s balance.

Above all, Dr. Schimpff seems to be
urging seniors to embrace life toward the end of achieving a sense of mental,
emotional, and physical well-being.

Reviewed by Frank Haight, retired pubic school teacher

Standards – Case and Types


The purpose of the post is to reinforce the need for standards and help classify standards

Case for Standards

The idea that Healthcare continuum (using information systems) extends not just across the departments in a healthcare enterprise, but across healthcare enterprises in different care settings (necessitating information exchange) has accelerated the adoption of standards. The other fact that the best of breed systems for different departments are now the preferred option to a single monolithic system for a single enterprise (requiring information and data exchange within the organisation to function as single entity) has again brought the notion of standards to the forefront. Even for organisations which have single enterprise wide system, healthcare standards are relevant as they need to standardise the entry and capture of healthcare data.

In summary standards are needed for representing and exchanging information to

  • Not compromise the safety of patients by preventing exchange of incorrect, insufficient and not understandable information , e.g. allergies , adverse reactions
  • Provide access to data for patients from different providers in uniform fashion
  • Allow aggregation of data for performance measurements and monitoring
  • Provide access in disparate systems for a longitudinal view of the patients medical history
  • Lower IT support costs by reducing need for data cleansing and data quality

Types of Standards

In general the implementation of standards fall in the following areas of categories

Voluntary Standards: These standards are usually developed in voluntary consensus by industry bodies or market groups associated with the industry. As these standards are developed by industry or someone associated with industry the standards are usually well regarded. The voluntary nature of standards will allow the implementers of standards to innovate on the base standards.

However the voluntary natures of standards ensure no enforcement mechanism, ambiguous interpretation and absence of mechanism for conflict resolution.

E.g. HL7V2.x standards developed by HL7 Inc which is a voluntary organisation

Regulatory Standards: These standards are usually legally binding contracts, laws or authority enforced regulations. Everyone must adhere to these standards and non-compliance is recognisable. There usually will be regulatory who ensure the compliance and assess the compliance.

However the regulatory standards encourage no innovation and sometimes do not cover all possible situations. Any conflicts on interpretation lead to long legal wrangles and the need for compliance assessment and inspection leads to large regulatory inspection teams

E.g. Usage of READ standards in UK NHS primary health care

Implementation and Conceptual Standards: Implementation standards are those have are dominant and wide usage and reinforce existing patterns. Conceptual standards are those which are developed to bring in new ways of thinking and working in the industry

E.g. Usage of XML, SOAP-WS

Product Standards: There are some standards which prescribe and recommend products or services. This can lead to better design of existing products and services or future products and services. This lead to a consistent and uniform feel to users of different products across the industry.

E.g. standards recommending common CUI (Clinical user interface)

Process Standards: A process is usually defined as a series of activities and logic that form a repeatable pattern. Process standards are those that focus on bringing efficiencies to the industry by developing repeatable processes.

E.g. Standard pathways for treating patients based on NICE guidelines

PS: Thanks to a friend who kept asking me for my next blog post and helping me revive my interest



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The Truth About Ovarian Cancer Screening – book excerpt


The New York Times editorial “False Promises on Ovarian Cancer” says it all. What is most concerning is that a third of doctors recommend what medical science shows not to be true: screening for ovarian cancer does NOT work.
Enjoy the excerpt from my book – The Thrifty Patient – Vital Insider Tips to Staying Healthy and Saving Money – and be smarter than 1/3 of doctors! Simple to read and incredibly informative.

Enjoy!

Ovarian Cancer Screening

One of the most feared cancers for many women is ovarian cancer, which occurs in one out of sixty-eight women. Unfortunately, like many cancers (lung, pancreatic), there is no screening test that has been helpful to detect the illness early and reliably proven to save lives.

Until organizations like the American Cancer Society (ACS) recommend certain tests or examinations, everything you may hear on the news or from friends about breakthroughs in screenings is inaccurate.

In the latest update by the American Cancer Society, women are urged to seek medical care if they have had the following symptoms, which could be early signs of ovarian cancer:

  • Abdominal swelling or bloating (due to a mass or accumulation of fluid)
  • Pelvic pressure or abdominal pain
  • Difficulty eating, or a feeling of being full quickly
  • Urinary symptoms (having to go urgently or often)

Certainly many benign causes also can cause similar symptoms. If you have these symptoms, they are not typical for you, and you aren’t sure what the cause might be, check with your doctor. The ACS acknowledges that two tests often used to “screen” for ovarian cancer are the blood test CA-125, a tumor marker, and/or a transvaginal ultrasound, an ultrasound probe placed in the vagina to evaluate the ovaries. The update correctly notes that in women at high risk for ovarian cancer and those with no risk, neither test has been shown to save lives.

Unfortunately, until medical researchers find a better and more precise test, women will need to be observant about their bodies. This is the best medical science has in trying to detect ovarian cancer early.

Even a Little Overweight, Inactivity Hurts the Heart

(HealthDay News) — Even a few extra pounds and just a little inactivity increased the risk of heart failure in a major study of American doctors.

“What this study shows is that even overweight men who are not obese have an increase in heart failure risk,” said Dr. Satish Kenchaiah, lead author of a report on the finding in the Dec. 23 issue of Circulation.

As for exercise, “even a little amount of physical activity appears to decrease the risk of heart failure,” said Kenchaiah, who did the research as a epidemiologist at Brigham and Women’s Hospital in Boston and is now at the U.S. National Heart, Lung, and Blood Institute.

The study has followed more than 21,000 doctors for two decades, measuring among other factors the influence of overweight and physical activity on development of heart failure, the progressive loss of ability to pump blood, which is often a prelude to major coronary events. Read more…

Cardiofy Heart Care Supplement