Chapter 2 Rule Revision Stakeholder Meeting

To: all Health Facilities

From: HFEMSD

Meetings are open to the public.

When: April 4, 2019 from 10:30 a.m. – 12:30 p.m. 
Where: Colorado Department of Public Health and Environment
4300 Cherry Creek Dr. South
Denver, CO 80246
Conference room C1E
(visitors, please check in at the front desk in building A, doors near the flag pole) 

UPDATED Audio line: 669-900-6833, conference code: 882 201 285 
UPDATED Webinar: Zoom meeting (https://zoom.us/j/882201285

To view the Chapter 2 meeting agenda go to:
https://drive.google.com/open?id=16ThL8KksZdFk6v9LGbQKmoM2RsIpNFSQ

Meeting documents, schedules and archived agendas are available on the department website : 
https://drive.google.com/open?id=1_PKQ45sRhtHZiYfwSmoPozsBgyOIoNvw

To sign up to receive email communications regarding Chapter 2 go to:
https://goo.gl/forms/eWns4V9OU0pXkSsp2

For further info:

Email crystal.cortes@state.co.us

Despite Public Protestations of of Bipartisanship, Many CEOs of the Largest US Health Care Corporations Appear Partisan, and Mainly Republican

Leaders of big health care organizations clearly are interested in
influencing public policy and government regulation in ways that favor
their organizations, and often indirectly themselves. On the other hand, big health care organizations have traditionally been non-partisan. 
While their leaders certainly may have political views, they used to
keep them very quiet.

In this sense, the leaders of big health care organizations have seemed similar to the leaders of large businesses in general.  For example, a recent New York Times article noted,

The Business Roundtable, the top lobbying organization for industry in Washington, is often characterized as a nonpartisan or bipartisan organization.

Yet,  recently, especially in the US, we have seen evidence that some health
care organizations have become partisan, albeit stealthily, throwing
their support behind political candidates, parties and organizations
that may support their policy and regulatory goals, even while they may
also support positions that go against the health care and public health
mission, or even may be frankly anti-democratic.  In the US,
organizations and their leaders now may support partisan aims with dark money, funds whose origin is disguised.

The recent NYT article noted above summarized some newly released research showing how corporate leaders in general have become more partisan, and more partisan in a particular sense. 

Based on Disclosed Personal Contributions, Since 2000 Most Top Corporate Executives Became Very Republican

The NYT article summarized a study of disclosed personal political contributions made by S&P 1500 executives from 2000 to 2017.

To be counted a supporter of Republicans or Democrats, executives had to direct at least two-thirds of their donations to candidates affiliated with one party.

They only released aggregate data, not data on particular industries, much less particular companies.  The main findings were:

More than a quarter of the executives studied gave enough to both parties to be classified as ‘neutral.’

But,

just 18.4 percent of the executives studied were designated as Democrats. The clear majority — 57.7 percent — demonstrated their affiliation through donations to the Republican Party. Indeed, 75 percent of donations from the median chief executive were directed to Republicans.

That strongly contrasts with the notion that big business and its leaders are non-partisan, although perhaps eager to be popular with people, particularly customers and politicians, with all sorts of political affiliations.

The study disclosed no information on any particular executive or company other than Tim Cook of Apple, one of the minority of apparently studiously bipartisan corporate leaders.

However, another article from October, 2018 in MarketWatch provided some particular information on how partisan leaders of health care corporations have become.

Many CEOs of Big Health Care Corporations are Very Republican

The MarketWatch article, which reported the journalists’ own study, also opened with the notion that corporate executives have been known for being non- or bi-partisan,

Company executives often steer clear of any appearance of partisanship, in large part because they don’t want to alienate customers and investors who back the other side.

Their study focused on disclosed political contributions from CEOs of S&P 500 companies, the largest publicly traded companies in the US, from 2017 through August 31, 2018, that is, those relevant to the most recent US national election, the 2018 mid-term election.

They also found that many executives were heavily partisan based on their personal political donations.

MarketWatch’s analysis found that among the CEOs who did contribute to party-affiliated committees, nearly all leaned heavily blue or red, with few donating equally to the two main parties. More than 84% of the 261 CEOs who contributed to partisan committees donated 70% or more of their money to one party or the other. And about 100 of the CEOs spent above the median amount and contributed 75% of their money to one party.

Overall,

The chief executives contributed a total of $7.4 million to Republican
groups, almost triple the $2.6 million contributed to Democratic
committees
.

The article presented a graphic showing the CEOs who were most partisan and contributed the most money.  It included several CEOs of big health care corporations.

The article included a database of CEOs ranked by amount contributed.  The amounts and proportions spent by the health care CEOs among the top 100 spenders were:

9. Timothy Wentworth, Express Scripts Holding: total contributions: $262,594, to Democrats, $10,000; to Republicans, $244,722

10. Robert A Bradway, Amgen: $235,800; D $41,000; R $194,800

13. Kenneth C Frazier, Merck: $196,961; D $48,500; R $140,000

14. Mark J Alles, Celgene; $195,682; D $15,000; R $173,600

16 Ian C Read, Pfizer; $181,833; D $25,800; R $145,400

23. David A Ricks, Eli Lilly; $128,020; D $23,300; R $89,500

25. Leonard S Schliefer, Regeneron Pharmaceuticals; $125,000; D $120,000; R $ 0

28. Marc N Casper, Thermo Scientific; $118,100; D $2,700; R $105,400

29. Brenton L Saunders, Allergan; $115,100; D $ 0; R $105,100

32 Michael F Nieidorff, Centene; $105,994; D $60,794; R $35,200

38 Miles D White, Abbott Laboratories; $90,400; D $ 0; R $90,400

39. Kent J Thiry, DaVita; $86,500; D $ 29,300; R $42,200

57. Clifford W Illig, Cerner; $47,000; D $0; R $42,100

70. Steven H Collis, Amerisource Bergen; $39,784; D $2,800; R $28, 100

85. Dow R Wilson, Varian Medical Systems; $30,800; D $0; R $15,800

88. Giovanni Caforio MD, Bristol-Myers Squib; $30,184; D $5,000 ; R $17,300

90. John F Milligan, Gilead Sciences; $30,000; D $0; R $20,000

92. Larry J Merlo, CVS;  $28, 733; D $0; R $15,400

93. Vincent A Forlenz, Becton-Dickinson; $28,700; D $11,500; R $0

100. George S Barrett, Cardinal Health; $27,168; D $13,900; R $5,000

So, there were 19 health care corporate CEOs among the top 100 of those giving disclosed political donations for the 2018 election.  Of those, 15 gave most of their donations to Republicans, 4 to Democrats.  Furthermore, note that many of the companies represented on the list have been Health Care Renewal “frequent fliers,” often discussed because of problems with leadership, governance and/or ethics.  

Discussion

While publicly often non–partisan, it appears that the top leaders of the biggest US health care corporations (and other corporations) have become increasingly partisan, and and increasingly supporters of one US political party, the Republican.  This is important since, as the NYT article noted:

The opinions held by executives have always resonated beyond their own industries, but their importance is more pronounced today. Mr. Trump, for example, has not hesitated to equate economic policy with foreign policy.

Also, the authors of the research paper summarized by the article wrote:

Especially since the Supreme Court’s decision in Citizens United, which allowed corporations to make unlimited independent political expenditures, corporate political spending can substantially affect politics and policymaking

In particular,

These executives wield enormous influence over not just policy, but the inclinations of their own employees. One of the most fascinating revelations of the study was that it also looked at the conduct of the businesses themselves, and in the process discovered that disclosures of political donations were highly correlated with the political leaning of its chief executive.

Political contributions by public companies do not have to be disclosed to shareholders, although some of companies do it. So the researchers looked instead at the which companies disclosed the donations to shareholders. Using an index developed by the Center for Political Accountability, the professors found that there was’“a statistically significant association between having a Republican C.E.O. and a lower’ disclosure score.

Also, in the era of Trump, the heavily Republican partisanship of top corporate CEOs seems at variance with how their corporations’ claim to be socially responsible, and

given the outspoken positions a number of executives have taken in recent years on social issues like climate change, guns and immigration policies.

Furthermore, the heavily Republican partisanship of  CEOs of big health care corporations seems at particular variance with the health care missions espoused by these corporations. 

For example, in 2018 we discussed the case of CVS, which boasts a code of ethics including respecting the covenantal relationship between pharmacists and patients,
promoting “the good of every patient,” acting with “honesty and
integrity,” and serving “individual, community and social needs.” It also has a social responsibility policy including “keeping the planet in balance,” and making “quality health
care more affordable, more accessible and more sustainable.”  However, CVS was revealed to have been contributing to a “dark money” organization called America First Policies, ostensibly a “social welfare” charity, but actually an organization devoted to promoting the Trump agenda.  While CVS said its support for AFP was related to the organization’s tax reform agenda, it also promoted various policies that seemed to contradict the CVS ethics and social responsibility policies.  In addition, the relationship between CVS and AFP only came to light after some AFP leaders were found to have made racist and pro-Nazi proclamations.  Whether CVS made is making contributions to other such groups was unknown.  At the time, we speculated whether the contributions to AFP reflected the self-interest of CVS leadership.

Now we find out that CVS CEO Larry Merlo gave $15,400 to Republicans in the run-up to the 2018 election, but nothing to Democrats.  This increases suspicion that CVS corporate political action is more about its CEO’s ideology than its professed mission. 

This anecdote, coupled with recent findings that big health care corporations’ policies about political activities are lax at best (look here), and the evidence above, should prompt concern about the political actions of other big health care corporations, and their intent. 

Thus not only is more investigation needed, at the very least, “public”
corporations ought to fully disclose all donations made to outside
groups with political agendas.  This should be demanded by at least the
corporations’ employees and shareholders, but also by patients, health
care professionals, and the public at large.

Meanwhile we are left with the suspicion that top health care corporate
management is increasingly merging with the current administration in
one giant corporatist entity which is not in the interests of health care, much less government by the people, of the people, and for the people.

Is Your Stem Cell Treatment Safe-Addressing the Proliferation of Unapproved Stem Cell Products

Proliferation of
Unapproved Stem Cell Therapy as a Cure-all
Stem cell therapy, drawn from infant umbilical cord blood or
from an adults’s own cells is the new snake oil cure-all. In the United States
the only FDA approved use of stem cell therapy is for treatment of blood
disorders like leukemia or hemophilia. (US Food and Drug Administration,
n.d.)

Here is the link to approved stem cell products in the US. https://www.fda.gov/biologicsbloodvaccines/cellulargenetherapyproducts/approvedproducts/default.htm
 Any other use is experimental and has
not received the rigor of the Federal Drug Agency investigation for patient
safety and efficacy. Unfortunately, thanks to unscrupulous direct-to-consumer
marketing, stem cell therapy is nearly as ubiquitous as Botox treatment. This article
highlights some of the dangers of unapproved treatment, what the FDA has done
to protect consumers, and resources for further investigation.
Are Stem Cell
Treatments Drugs?
The FDA considers stem cell treatment to be an injectable
drug therapy and as such is under the purview of the agency. Many of these high
profit stem cell clinics offering the treatment disagree with the FDA
classification and have been flouting the rules.

Risks of Stem Cell
Treatment

  1.  Stem cell products are being manufactured in
    facilities that are not inspected or run by FDA patient safety standards.
    Injectables that are created in an unsterile environment run a high risk of
    infection for patients. Timothy Lunceford of Texas was injected with stem cells
    for joint pain and was hospitalized for 58 days with a blood infection and E.
    coli.
     (McGinley, 2019)
  2.  Nonscientists are creating stem cell products which
    means they do not assess, test, or control for unintended consequences the way
    a controlled scientific experiment does. Three people lost their sight after
    being injected with stem cells as a treatment for macular degeneration.
     (alpha1.org,
    2018)
  3.  Umbilical cord blood containing stem cells, billed
    as the miracle of life, can have different reactions in people. At least 17
    people have been hospitalized after being injected with products containing
    umbilical cord blood.
    (McGinley, 2019)
  4.  Site infections from injection of stem cell
    products is also common and can require hospitalization. John Herzog, MD
    injected himself as a test of safety before he would recommend the product to
    his patients and he ended up in the hospital with a bone infection and a blood
    clot.
    (McGinley, 2019)
  5.  People promoting stem cell treatments often have
    no scientific or medical background and their only motive is to make money. Liveyon
    products sold as stem cell therapy were tested by Lisa Fortier, a Cornell
    University regenerative medicine researcher and she found that nine of the
    products did not contain stem cells or even a single live cell.
    (McGinley, 2019)
  6.  Two people died in Florida after receiving stem
    cell injections in 2012.
     (McGinley, 2019)

Regulatory Actions
Taken By the US

Centers for Disease Control and Prevention tested and found
that bacterial contamination occurred at the manufacturing level prior to
clinical use of the stem cell products distributed by Liveyon of Yorba Linda,
California. A product recall for Liveyon ReGen treatment vials occurred 4
months after the company’s product tested positive for e coli. Most worrisome
is Liveyon has opened an operation in Cancun, Mexico so American patients can
receive treatment without the oversight of the FDA. (McGinley,
2019)
The FDA has the authority to regulate drug, cosmetic, and
scientific treatments in the US. New drugs or treatments are supposed to apply
for an Investigational New Drug (IND)application. The agency has reviewed 5,322
stem cell products in clinical trials. To learn more about stem cell products
which have been reviewed in a clinical trial follow this link: https://clinicaltrials.gov/ct2/results?term=stem+cell+therapies

The FDA sued the US Stem Cell Clinic, LLC in Florida for failure to respond to their inspection concerns. The agency also took action against StemImmune, Inc in California to prevent the use of a dangerous and unproven treatment. In 2017, US marshals seized vials of smallpox which were being used to create stem cells and given to cancer patients in California. In November 2017, the FDA published 4 guidance documents on risk and regulatory compliance for regenerative medicine products. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585345.htm


So, it’s quite simple
you should not be using any stem cell therapy which has not been in a clinical
trial under the auspices of the FDA. And you should definitely avoid companies
which promote stem cell treatments despite being found to have contaminated
products by the CDC. These opportunists do not sign a hypocritic oath like
physicians for patient care.
This is the healthpolicymaven signing off encouraging you
not to sign blanket release forms when you check into a treatment center. Do
specify that for why you consent and that for which you decline.
Roberta Winter is a freelance journalist and health policy
analyst whom has published under the trademark healthpolicymaven since 2007.
This article does not give medical advice, but is an advisory on health policy.
She is the author of Unraveling U.S. Healthcare-A Personal Guide, published in
2013.


alpha1.org. (2018, May 16). FDA Files Lawsuits to
Stop Unapproved Stem Cell Therapies. alpha1.org. Retrieved March 24,
2019, from
https://www.alpha1.org/Alphas-Friends-Family/Resources/News/ArtMID/5952/ArticleID/7860/FDA-files-lawsuits-to-stop-unapproved-stem-cell-therapies
McGinley, W. W. (2019, February 27). Miraculous Stem
Cell Therapy Has Sickened People in Five States. The Washington Post,
pp. 1-10. Retrieved March 9, 2019, from
https://www.washingtonpost.com/national/health-science/miraculous-stem-cell-therapy-has-sickened-people-in-five-states/2019/02/26/c04b23a4-3539-11e9-854a-7a14d7fec96a_story.html?utm_term=.0a2ea7b69b72
US Food and Drug Administration. (n.d.). FDA
Consumer Updates
. doi:ucm286155

The Transparency International 2018 Corporate Political Engagement Index- Pharma Appears All Too Comfortable with the Revolving Door and Making Opaque Political Contributions

Introduction: Big Organizations, Government Policy and Regulation, and Politics

Leaders of big health care organizations clearly are interested in influencing public policy and government regulation in ways that favor their organizations, and often indirectly themselves.  We expect such leaders and organizations to make their policy preferences known.  However, increasingly we have found that they take shadowy routes to their policy goals.

We have frequently discussed how large health care organizations may use less than transparent methods to advocate for their policy and regulatory objectives.  Their public relations departments may fund patient advocacy organizations and medical societies that support these objectives, so-called third-party strategies.  They may fund distinguished professionals and academics as key opinion leaders for the same purposes.  Often they do this in systematic ways so that there efforts amount to stealth advocacy or stealth lobbying campaigns.

Even more concerning is organizational support of the revolving door.  Top organizational leaders may move into government policy and/or regulatory positions relevant to the organizations’ goals.  Government policy and regulatory leaders may know that lucrative positions in these organizations are available when they leave government.  The revolving door is certainly a serious type of conflict of interest, and some deem it corrupt.

Big health care organizations have traditionally been non-partisan.  While their leaders certainly may have political views, they used to keep them very quiet.  Recently, especially in the US, we have seen evidence that some health care organizations have become partisan, albeit stealthily, throwing their support behind political candidates, parties and organizations that may support their policy and regulatory goals, even while they may also support positions that go against the health care and public health mission, or even may be frankly anti-democratic.  In the US, organizations and their leaders now may support partisan aims with dark money, funds whose origin is disguised. 

The Transparency International 2018 Corporate Political Engagement Index

A recent report by Transparency International was made public, with little fanfare, in late 2018 that was meant to throw a little light on corporate “engagement” in politics.  It included some interesting information on a few multinartional pharmaceutical companies.

The report introduction stated:

For companies, corporate political engagement carries clear risks of bribery and corruption, conflicts of interest and reputational damage. Any interactions with the political process need careful management to avoid falling foul of anti-bribery and corruption legislation. The risks are increased by the fact that companies are vulnerable to mistakes or abuse by employees and third parties acting
on their behalf such as agents, advisers and consultant lobbyists.

Methods

The study on which the report was based concentrated on 104 large corporations that are active in the UK.  These included the following large multinational pharmaceutical companies:

AstraZeneca
– EISAI
GlaxoSmithKline
Johnson & Johnson
Novartis
Pfizer
Roche
Shire

The study was based on 20 questions divided in 5 areas.

Three areas were basically about transparency of  and accountablity for political activities.  These included
– Control Environment, including having transparent policies, methods for ensuring their enforcement, and oversight of same by the board of directors
– Responsible Lobbying, including adequate policies and transparency
– Transparency in Reporting

One was about the Revolving Door, and included whether the company has a “cooling-off period” for people going through the revolving door back to the company.  However, it did not directly mention people going directly from leadership positions within the company to government.

One was about Political Contributions, and included whether the company bans them (perhaps the strongest question of the group.)

Each question in each area was scored from 2 for meeting expectations to 0 for failing to do so.  Scores were normalized on a scale going from 100 (best) to 0 (worst), and and summarized in “bands” from A (83.3 – 100) down to F (0 – 16.6)

Results

For the three areas regarding transparency and accountablity the results per company were:

Control Environment
 
– AstraZeneca            C
– EISAI                      C
– GlaxoSmithKline    A
– Johnson & Johnson C
– Novartis                   F
– Pfizer                       C
– Roche                      E
– Shire                        C

Responsible Lobbying

– AstraZeneca            E
– EISAI                      F
– GlaxoSmithKline    B
– Johnson & Johnson E
– Novartis                   E
– Pfizer                       F
– Roche                      C
– Shire                        E

Transparency in Reporting

– AstraZeneca            C
– EISAI                      C
– GlaxoSmithKline    A
– Johnson & Johnson C
– Novartis                   C
– Pfizer                       C
– Roche                      C
– Shire                        C

For the Revolving Door

– AstraZeneca            F
– EISAI                      F
– GlaxoSmithKline    A
– Johnson & Johnson F
– Novartis                   D
– Pfizer                       F
– Roche                      E
– Shire                        F

For Political Contributions

– AstraZeneca            F
– EISAI                      F
– GlaxoSmithKline    B
– Johnson & Johnson C
– Novartis                   F
– Pfizer                       E
– Roche                      E
– Shire                        E

Summary and Discussion

Note that the pharmaceutical companies did not do too badly on the measures of transparency and accountablity, but except for GSK did quite badly on minimizing the revolving door, and again with the partial exception of GSK did very badly on avoiding political contributions.

This suggests that at least some big multinational pharmaceutical corporations that do business in the UK, but also in the US and many other developed countries, have worrisome attitudes towards and likely practices affecting their use of political influence.

The Revolving Door

The majority of companies did not show any real concern about the problem of the revolving door

In the US, this problem seems to be getting worse.  In particular under the Trump regime we see more instances of the  incoming revolving door, that is, people moving directly from corporate leadership positions to government policy and regulatory positions in which they could potentially make decisions affecting the corporations from which they came.  This is potentially a more serious problem than the outgoing door, yet it was not even discussed in the TI study.

We have repeatedly said,  most recently a few days ago, …

The revolving door is a species of conflict of interest. Worse, some
experts have suggested that the revolving door is in fact corruption. 
As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

The ongoing parade of people transiting the revolving door from industry
to the Trump regime once again suggests how the revolving door
may enable certain of those
with private vested interests to have disproportionate influence on how the government works.  The country
is increasingly being run by a cozy group of insiders with ties to
both
government and industry. This has been termed crony capitalism. The latest cohort of revolving door transits
suggests that regulatory capture is likely to become much worse in the near future.

Corporate Partisanship, Political Contributions, and Dark Money

Given the increasing evidence that large corporations have become partisan in the US, it is particularly worrisome that at least the pharmaceutical corporations in the TI study have not taken a clear stand against making direct political contributions, or even in favor of making such contributions transparent.

Note that the TI report included the directive “do not make political contributions” among its “principles for responsible political engagement,” adding:

Corporate political contributions should not be made on behalf of the company other than in exceptional  circumstances where they provide general support for a genuine democratic process, with full transparency and full explanation.

On the other hand, as we said last year,…

 Health care corporations recent and current funding of dark money groups
seems to openly conflict with the corporations’ promises of social
responsibility.  The slanting of these efforts towards one end of the
political spectrum, one party, and now the current president suggest
that these corporations may have partisan agendas.

Furthermore, the increasing knowledge of these corporate actions raises a big question: cui bono? who benefits?

It is obvious why a pharmaceutical company, for example, might want to defeat legislation that would lower its prices.

It is not obvious why it would want to consistenly support actions by
one party, or by people at one end of the political spectrum, even if
some such people seem “anti-business.”  After all, for years big
corporations and their executives openly gave money to both US parties
and their candidates, apparently in the belief that this would at least
allow more visibility for the corporations’ priorities no matter who was
in power.

Now, the most obvious theory is that the new practice of secret
donations only in right-wing, Republican, and/or pro-Trump directions,
which must be
orchestrated by top corporate management, and which are not disclosed to
employees or smaller corporate shareholders, are likely made to support
the top managers’ self interest more than the broad priorities of the
corporations and their various constitutencies.

Thus not only is more investigation needed, at the very least, “public”
corporations ought to fully disclose all donations made to outside
groups with political agendas.  This should be demanded by at least the
corporations’ employees and shareholders, but also by patients, health
care professionals, and the public at large.

Meanwhile we are left with the suspicion that top health care corporate
management is increasingly merging with the current administration in
one giant corporatist entity which is not in the interests of health care, much less government by the people, of the people, and for the people.

OASIS Submissions Failing due to Wellsky Error

To: Federally Certified Skilled Home Health Facilities Administrators, Directors of Nursing, OASIS Coordinators, Billing and Coding Personnel, Licensed Home Health Facilities Administrators

From: The Education and Technical Assistance (ETA) Branch of the Health Facilities and Emergency Medical Services Division (HFEMSD)

There is a known error with Kinsser/Wellsky OASIS submissions. Users will see reports from Wellsky indicating OASIS batches submitted properly. However, the CMS validation reports from CASPER cites Fatal Error -5050 Inconsistent M1033 Values: If M1033-10 is equal to 0, then at least one item M1033-1 through M1033-9 must equal 1. This means that particular assessment is not yet successfully submitted and RAP requests will fail.

The QTSO Help Desk at 800-339-9313 has identified this as an error with the .xml packaging of files by Kinsser/Wellsky since 3/10/19. Please contact your vendor representative for more information.

This is thought to be a software-specific failure, not affecting other vendors.

Questions?: Please email betty.metz@state.co.us

OASIS D Classes *FREE*

To: Federally Certified Skilled Home Health Facilities Administrators, Directors of Nursing, OASIS Coordinators, Billing and Coding Personnel, Licensed Home Health Facilities Administrators

From: The Education and Technical Assistance (ETA) Branch of the Health Facilities and Emergency Medical Services Division (HFEMSD)

ETA will offer classes on specific OASIS topics in La Junta, Denver, Grand Junction, Boulder, Craig and Pueblo featuring OASIS D items and guidance. You may choose to take sessions all at once or individually as your interest and needs dictate. All registration is first-come, first-served, even for sessions within a specific facility.

ETA reserves the right to cancel classes with low registration. This is a possibility for some Denver sessions. Early registration is helpful.

OASIS D Basics (One Session): Course ID 1082008
This beginning three-hour class is how to get started with OASIS D.

OASIS D Item-by-Item (2 Sessions): Course ID 1082009
This practical application class reviews item-by-item data set completion. We will follow Mrs. Green’s assessment, which will require two sessions to complete. Attendance at both sessions is required to complete this class.

OASIS Quality Measures (One Session): Course ID 1066910
This course assumes familiarity with the OASIS D Item Set, covering more advanced content and application.

To see additional session details and register for on-site attendance for one of these offerings:

  1. Go to: http://www.train.org

  2. Log in to your existing TRAIN account, or new users click “Create an Account”

  3. Once you’ve logged in, or created an account, Search (top right) for the appropriate Course ID. (See above for desired training)

  4. Click link for desired course.

  5. Click the “Registration” tab.

  6. Click the “Register” button for the session you wish to attend.

  7. Remember to register separately for each desired course.


Click for a detailed example of the above process (if needed)

Questions?: Please email:betty.metz@state.co.us

TB Update and Skin Testing Practicum for Health Care Providers

To: Medical Directors and Directors of Nursing

From: The Denver Metro TB Clinic and CDPHE Tuberculosis Program 

SPACE STILL AVAILABLE!!!

The Denver Metro TB Clinic invite nurses and other health care providers from home health agencies, clinics, and long-term care facilities to attend a tuberculosis update and skin testing practicum on Thursday, March 28th, 2019 from 12:30pm – 5:00pm in the Public Health Auditorium, 2nd floor at Denver Public Health (605 Bannock Street, Denver). 

Course Objectives are: 
– Express an increased and updated knowledge of TB infection and TB disease
– Demonstrate their skill in placing and reading the TST

Who Should attend?: Health care providers working in hospitals, home health care agencies, jails and other long-term care facilities, occupation health, Civil Surgeon’s offices, and local public health agencies.

For more details and a link to register go to: http://denverpublichealth.org/home/clinics-and-services/tuberculosis-clinic/for-providers/tb-education 

Registration cost is $60 
Space is very limited so please register early. 

For more information please contact Carolyn Bargman at 303-602-7243 cbargman@dhha.org with any questions. 

For Whom the Door Revolves: Founder and Director of Multiple Biotechnology Companies Became Director of the NCI and Now Nominated to be Acting Commissioner of the FDA

Dr Scott Gottlieb, the first commissioner of the US Food and Drug Administration (FDA) appointed by President Trump, has announced his plans to depart.  At the time of his nomination, Dr Gottlieb’s many conflicts of interest were well known (see this NY Times article, for example), as were his exceedingly friendly views of the pharmaceutical/ biotechnology industry (see this long ago post, for example).

President Trump’s regime just announced a new acting commissioner, Dr Norman (“Ned”) E Sharpless, another industry fan.

Founder and Director of Several Biotechnology Companies

G1 Therapeutics

As StatNews just reported, Sharpless “founded two biotech companies.”  His fans cited as proof of the “breadth of his experience,”

the $105 million that G1 Therapeutics, a company Sharpless co-founded, raised in 2017 while developing the lung and breast cancer drug trilaciclib.

Apparently, his work in industry has made Dr Sharpless rich

According to public records, founding these companies may have paid off.  Sharpless reported selling more than 400,000 shares of G1 Therapeutics in October 2017 – which, at the time, were worth more than $9 million.

So far, I have seen no other recent reporting that goes into any detail about Dr Sharpless’ connections to the pharmaceutical and biotechnology industry.  Nor did I see much reporting about these relationships from the time Dr Sharpless was appointed to head the National Cancer Institute in October, 2017, again by the Trump regime.

A little digging provided a bit more detail about his relationship to G1 Therapeutics.Crunchbase revealed that Dr Sharpless was a Co-Founder of G1 Therapeutics, a member of its Scientific Advisory Board, and a member of its board of directors.  A  press release from the UNC Lineberger Comprehensive Cancer Center did gush a bit about his ability to raise capital for G1 Therapeutics in May, 2017, a few months before he was appointed to head the NCI.

G1 Therapeutics, Inc., a clinical-stage oncology company in Research Triangle Park with ties to the University of North Carolina Lineberger Comprehensive Cancer Center, has raised approximately $108.6 million in an initial public offering of its stock. The company began trading on the NASDAQ Global Market under the ticker symbol ‘GTHX’ on May 17.

Furthermore,

Founded in 2008 with support from KickStart Venture Services, a UNC-Chapel Hill program that works to turn University research into new companies, G1 is developing novel therapeutics based on discoveries made by UNC Lineberger Director Norman E. Sharpless, MD, and Kwok-Kin Wong, MD, PhD, then at Dana-Farber Cancer Institute and now at the Perlmutter Cancer Center, NYU Langone Medical Center. The early research that led to the formation of G1 was supported by the University Cancer Research Fund.

Congratulations to Dr. Sharpless and the entire G1 Therapeutics team for achieving this major milestone, making an impressive market debut and accelerating important advances in cancer therapies,’ said Judith Cone, Vice Chancellor for Innovation, Entrepreneurship and Economic Development at UNC-Chapel Hill.

It was an advance in raising capital, although the eventual clinical value of the venture may not yet be clear.  Trilaciclib is apparently still under development and has not been yet subject to big randomized clinical trials.

Sapere Bio

StatNews also reported,

The second company that Sharpless-directed science helped spawn is Sapere Bio, also based in North Carolina

which is

developing a diagnostic text to measure a patient’s ‘molecular age.’

whatever that may be, and whatever use it may turn out to have, or not.

There is not much more information about Dr Sharpless’ relationship with Sapere Bio.  In February, 2019, the WRAL Tech Wire stated,

Physician Norman ‘Ned’ Sharpless and Natalia Mitin, Ph.D., founded Sapere Bio in 2013. It was originally called HealthSpan Diagnostics, a reference to the period in your life when you’re healthy. The company grew out of the research of Sharpless, who at the time was director of the Lineberger Cancer Center at the University of North Carolina at Chapel Hill.

Apparently, by the time this article was written, he was “no longer involved” with the company.

Consulting and Other Financial Relationships

Further web searching revealed that Dr Sharpless had to disclose other financial relationships with health care corporations in the past.  In 2017, he was one of multiple authors on a paper in The Oncologist (Patel NM et al. Enhancing next-generation sequencing-guided cancer care through cognitive computing. Oncologist 2017; 22: 1-7.)

Norman E. Sharpless: G1 Therapeutics, Unity Biotechnology, HealthSpan Diagnostics (C/A, IP,SAB, OI), Pfizer (H)

Where

(C/A) Consulting/advisory relationship; (RF) Research funding; (E) Employment; (ET) Expert testimony; (H) Honoraria received; (OI) Ownership interests; (IP) Intellectual property rights/ inventor/patent holder; (SAB) Scientific advisory board

The ProPublica Trump Town database also stated that Dr Sharpless was a former consultant to Unity Biotechnology and that

Compensation to be an advisor to Unity is solely through an option to purchase up to 50,000 shares of their stock. Roughly half of these options are unvested.

I cannot find anything more about Dr Sharpless’ relationship to Unity Biotechnology, which is apparently yet another start-up biotechnology corporation with drugs in the development pipeline.
 
Again, it appears that Dr Sharpless may have ended these relationships when he became NCI director.  A disclosure in December, 2018, for a talk he gave at the American Society of Hematology included

Sharpless: Pfizer(relationship ended): Honoraria; G1 Therapeutics (relationship ended): Membership on an entity’s Board of Directors or advisory committees; G1 Therapeutics (divested): Equity Ownership; Healthspan Diagnostics (relationship ended): Membership on an entity’s Board of Directors or advisory committees; Healthspan Diagnostics (divested): Equity Ownership; Unity Biotechnology (divested): Equity Ownership; Unity Biotechnology (relationship ended): Membership on an entity’s Board of Directors or advisory committees; Unity Biotechnology (relinquished)

Summary

Dr Norman “Ned” E Sharpless is clearly an experienced academic physician, and hence is a welcome contrast with the many ill-informed ideologues lacking any experience or expertise in biomedical research, medicine, health care or public health recently appointed to important US government health care related positions (for the most recent example, look here).

However, while he held a major academic leadership position, Dr Sharpless had multiple important conflicts of interest, including founding and serving on the boards of directors of several for-profit biotechnology companies, as well as having other financial relationships with health care corporations.  He apparently had already become rich via these relationships before he became director of the US National Cancer Institute (NCI), although he apparently ended the relationships when he assumed the directorship.  As the head of the NCI, he was in a position to have some influence over US health care research policy affecting the pharmaceutical and biotechnology industry.  Hence his appointment to that position was an example of the revolving door.

Now about one and one-half year later, his position as acting commissioner of the FDA will give him much more influence over pharma and biotech.  This appointment is an even more strking example of the revolving door.

Both examples seem to have so far gotten lost in the continuing chaos generated by the Trump regime.

Yet, as we have said until blue in the face, and most recently less than a month ago

The revolving door is a species of conflict of interest. Worse, some
experts have suggested that the revolving door is in fact corruption. 
As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

The ongoing parade of people transiting the revolving door from industry
to the Trump regime once again suggests how the revolving door
may enable certain of those
with private vested interests to have disproportionate influence on how the government works.  The country
is increasingly being run by a cozy group of insiders with ties to
both
government and industry. This has been termed crony capitalism. The latest cohort of revolving door transits
suggests that regulatory capture is likely to become much worse in the near future.

Remember to ask: cui bono? Who benefits? The net results are that big
health care corporations increasingly control the governmental
regulatory and policy apparatus.  This will doubtless first benefit the
top leadership and owners/ stockholders (when applicable) of these
organizations, who are sometimes the same people, due to detriment of
patients’ and the public’s health, the pocketbooks of tax-payers, and
the values and ideals of health care professionals.  

 The continuing egregiousness of the revolving door in health care shows
how health care leadership can play mutually beneficial games,
regardless of the their effects on patients’ and the public’s health. 
Once again, true health care reform would cut the ties between
government and corporate leaders and their cronies that have lead to government of, for
and by corporate executives rather than the people at large.