HOME PAGE OF SEMMEL-WEIS.ORG Semmel Weis in Landeck, Austria with Die Silberspitze (SilverPeak) in the background Ignaz Semmelweis on Hungarian postage stamp Frodo Ring introduces RED BOX WARNING AGAINST KAPLAN-MEIER Grim Reaper introduces the SAN MIGUEL (2008) TRILOGY IS THERE AN ALTERNATIVE TO INFOMERCIALS? THESE FOUR RATS GAVE THEIR LIVES DEMONSTRATING THAT THERE IS AN ALTERNATIVE. Chinese woman holding giant, bamboo-eating rat Bright future for Johnson&Johnson DARZALEX
FDA Agent Badge gets you into THE JOHNSON & JOHNSON RAP SHEEP Dr ROBERT Z ORLOWSKI, one of the MAGNIFICENT EIGHT represented here as a SUPERMAN in the area of multiple myeloma 83% survival at Months=30 is the inflated survival indicated in a misleading Kaplan-Meier graph Dr Paul Richardson wearing the recommended badge which reflects that Big Pharma's power over him has the strength of $19.6 million Best Hospitals ranking by USNews HOW MANY SUBJECTS PER GROUP? Dr SAGAR LONIAL debates Dr Paul Richardson Meletios Dimopoulos
A VERY SPECIAL INTEREST HERE TO SEE YOU William James Mayo Dr Matt Kalaycio unable to dispute payment Incongruity arrow ODOMZO may exhibit a Kalaycio-Boom in a Mayo Clinic Rochester clinical trial having Dr Francis Buadi as Principal Investigator      

Dr. John H. Noseworthy,
President and CEO, Mayo Clinic,
noseworthy.john@mayo.edu

12Sep2018 Dear Dr. Noseworthy:

I apologize for my tardiness in replying to your email request of 27Apr2018 for feedback on our Mayo Clinic visit during April 2018:

Mayo Survey request

I delayed because I needed time to gather my thoughts, which I have now begun to do, and finding the survey format too limiting, I offer a first installment of my reply in the form of an open letter.

Generally speaking, we were often greatly impressed at the superior quality of Mayo services, but these instances will be described at a later time, as what needs to be repaired is so urgent that it demands to be dealt with first.

Yours truly,
Semmel Weis



OUR VISIT TO MAYO

PART 1

CONFLICT OF INTEREST
by Semmel Weis
First published 12Sep2018  Last edited 18Sep2018  04:33pm Pacific Time


IN A NUTSHELL

Captured in an Economist cartoon below is what this letter is about.  Deliberately outsizing "The Economist" logo intends to render vivid the message that where a description of our visit to Mayo should have been medical, the evidence coerces the description into being economic.  What at first glance may appear to be medical relationships, closer examination suggests can be understood primarily as a flow of dollars.

The Economist logo

The Economist cartoon showing a drug salesman masquerading as a doctor
Let the sunshine in    New efforts to reveal the ties between doctors and drug firms    economist.com



ONE EXCEPTIONAL MAYO DOCTOR

On our visit to the Rochester Mayo Clinic in April 2018, we communicated with five doctors, the only one of whom administered treatment being Dr Francis Buadi.

When we consulted the CMS.gov OpenPayments web site to find the drug-company (and sometimes the medical-device-company) payments that our five Mayo doctors had some involvement in, we were astonished to discover that the only doctor who administered our treatment seemed to be an OpenPayments outlier:

OpenPayments logo

Each OpenPayments total at the base of each doctor's column is the sum of the payments displayed in that column.  "N/A", standing for "Not Available", possibly means zero payments.  Doctors are sorted from largest to smallest OpenPayments totals, with alphabetic ordering by surname taking over in case of a tie.  Date of data retrieval from OpenPayments is included because CMS.gov numbers are occasionally "refreshed", meaning adjusted slightly, as corrections are made or straggling information is included, or differences resolved, and which will serve to explain why some numbers might be slightly different upon the reader's attempt to verify them.  Although 2017 OpenPayments have been released, they were not available at the time of our Mayo-Clinic visit in April 2018 and if included would not alter any conclusions drawn.

CAUTION!

"The transparency display of transactions from applicable manufacturers and group purchasing organizations to physicians and teaching hospitals does not necessarily mean any of the reported financial relationships are improper."  openpaymentsdata.cms.gov

"Sharing information about financial relationships alone is not enough to decide whether they’re beneficial or improper.  Just because there are financial ties doesn’t mean that anyone is doing anything wrong."  cms.gov/OpenPayments

"If you are a physician who served as a principal investigator on a research study, you may see the payments associated with that research study listed under your name.  This does not necessarily mean the payments are attributed to you."  FAQ #12224  cms.gov/OpenPayments

Dr FRANCIS K BUADI of the Mayo Clinic, Rochester MN
Dr FRANCIS K BUADI
Mayo Clinic, Rochester MN
Dr JAMIE VANGOMPEL of the Mayo Clinic, Rochester MN
Dr JAMIE J VANGOMPEL
Mayo Clinic, Rochester MN
Dr SCOTT STAFFORD of the Mayo Clinic, Rochester MN
Dr SCOTT L STAFFORD
Mayo Clinic, Rochester MN
2016
General Payments            N/A
Research Payments          N/A
Associated Research   $2,954,824
2016
General Payments         $233
Research Payments         N/A
Associated Research        N/A
2016
General Payments          $44
Research Payments        N/A
Associated Research       N/A
2015
General Payments          $1,087
Research Payments           N/A
Associated Research   $1,130,765
2015
General Payments        $688
Research Payments        N/A
Associated Research       N/A
2015
General Payments          N/A
Research Payments        N/A
Associated Research       N/A
2014
General Payments        $2,482
Research Payments        $725
Associated Research    $79,511
2014
General Payments        $334
Research Payments        N/A
Associated Research       N/A
2014
General Payments          N/A
Research Payments        N/A
Associated Research       N/A
2013 (Aug-Dec)
General Payments          $471
Research Payments         N/A
Associated Research    $27,705
2013 (Aug-Dec)
General Payments           N/A
Research Payments         N/A
Associated Research        N/A
2013 (Aug-Dec)
General Payments          N/A
Research Payments        N/A
Associated Research       N/A
Dr Francis K Buadi had some involvement in drug-company payments
covering Aug2013-Dec2016
and totalling

$4,197,570
as downloaded on 16May2018 from
OpenPaymentsData.CMS.gov
Dr Jamie J Vangompel had some involvement in medical-device-company payments
covering Aug2013-Dec2016
and totalling

$1,255
as downloaded on 16May2018 from
OpenPaymentsData.CMS.gov
Dr Scott L Stafford had some involvement in medical-device-company payments
covering Aug2013-Dec2016
and totalling

$44
as downloaded on 16May2018 from
OpenPaymentsData.CMS.gov

Dr ESAYAS B KEBEDE of the Mayo Clinic, Rochester MN
Dr ESAYAS B KEBEDE
Mayo Clinic, Rochester MN
Dr JAMES A MARTENSON of the Mayo Clinic, Rochester MN
Dr JAMES A MARTENSON
Mayo Clinic, Rochester MN
Dr Esayas B Kebede had ZERO involvement
in any OpenPayments, as indicated on 16May2018 by the absence of his name in

OpenPaymentsData.CMS.gov
Dr James A Martenson had ZERO involvement
in any OpenPayments, as indicated on 16May2018 by the absence of his name in

OpenPaymentsData.CMS.gov

With respect to the large payment amounts that Dr Buadi has had some involvement in, it seems reasonable for his patients to wish to know whether any portion of them went directly into his own pocket, as some believe to be a commonplace occurrence in the drug business:

BMJ logo

Key opinion leaders: independent experts
or drug representatives in disguise?


Ray Moynihan, visiting editor, BMJ      19Jun2008     ncbi.nlm.nih.gov

Ray Moynihan examines the role of the influential experts paid by industry to help "educate" the profession and the public


In the world of medicine, "key opinion leader" is the somewhat Orwellian term used to describe the senior doctors who help drug companies sell drugs.  These influential doctors are engaged by industry to advise on marketing and help boost sales of new medicines.  Across all specialties, in hospitals and universities everywhere, many leading specialists are being paid generous fees to peddle influence on behalf of the world’s biggest drug companies.

Kimberly Elliott, who was a drug company sales representative for almost two decades in the United States, puts it directly.  "Key opinion leaders were salespeople for us, and we would routinely measure the return on our investment, by tracking prescriptions before and after their presentations," she said.  "If that speaker didn’t make the impact the company was looking for, then you wouldn’t invite them back."  [...]

"These people are paid a lot of money to say what they say," she said.  "I’m not saying the key opinion leaders are bad, but they are salespeople just like the sales representatives are."  [...]


If Dr Buadi has been keeping for his personal use any portion of the payment dollars that he has had some involvement in, then this might be in violation of the core principles upon which the Mayo Clinic was founded, principles like those declared on the three pages reproduced below from a document titled Faculty Compensation, The Mayo Clinic Model, 2014:

Page 1:  If "Honey, we fooled them again!" is an in-joke, then it means what?  One hopes nothing as cynical as — "The rote recital of lofty ideals has little correspondence to reality"?

01


Page 5:  Of particular relevance is the Mayo Clinic Bylaws 2013 paragraph in the lower-right corner.

05


Page 10:  Of particular relevance are the Guiding Principles attached to the cluster of five bullets on the left.

10

However, if the above guiding principles aim to restrict only the salaries coming from Mayo, but do not intend to limit income from outside sources like drug companies, then today's Mayo administration might judge Dr Buadi to be in compliance with founding principles even if he had pocketed the entire $4.2 million of the Drug-Company payments that OpenPayments reports him having some involvement in.

In any case, ambiguous though the OpenPayments totals at present are, it can be argued that they should be disclosed to patients because of patients' overriding need to have all pieces of evidence concerning the question of whether the gentleman standing before them with the stethoscope in a white coat is a doctor committed to protecting his patients' health, or a drug salesman committed to promoting his company's products.  The 2016 Mayo Clinic Conflict of Interest Policy would seem to be on the side of exactly such full disclosure:

William James Mayo (1861-1939)
William James Mayo (1861-1939)
One of the seven founders of the Mayo Clinic
Photograph by J.K. Stevens & Son Co.  wellcomeimages.org


LOGO Mayo Clinic

Conflict of Interest Policy

Approved May 2016
Mayo Clinic Board of Governors
mayo.edu


Guiding principles

"I would admonish you, above all other considerations, to be honest.  I mean honesty in every conception of the word: let it enter into all the details of your work; in the treatment of your patients and in your association with your brother practitioners."  —  Dr. Will Mayo
[...]
The first step to managing any conflict of interest is thorough disclosure.
    [...]

Showing Buadi patients his $4.2 million OpenPayments total may qualify as disclosure, but perhaps it is only the beginning of what might be considered thorough disclosure, where the next step toward thorough disclosure requires delving into who exactly it was who made those payments.


BUADI-INVOLVED PAYMENTS CAME PRIMARILY FROM NOVARTIS

We are able to calculate from the raw data in the same OpenPayments source that the payments that Dr Buadi has been involved in Aug2013-Dec2016 came from six drug companies, but mostly Novartis:

Novartis 4,081,284
GlaxoSmithKline    $ 72,293
Amgen (+ Onyx) $ 40,426
Millenium $ 1,857
Pfizer $ 1,274
Celgene $ 437
TOTAL $ 4,197,571

CAUTION!
"The transparency display of transactions from applicable manufacturers and group purchasing organizations to physicians and teaching hospitals does not necessarily mean any of the reported financial relationships are improper."  openpaymentsdata.cms.gov
"Sharing information about financial relationships alone is not enough to decide whether they’re beneficial or improper.  Just because there are financial ties doesn’t mean that anyone is doing anything wrong."  cms.gov/OpenPayments
"If you are a physician who served as a principal investigator on a research study, you may see the payments associated with that research study listed under your name.  This does not necessarily mean the payments are attributed to you."  FAQ #12224  cms.gov/OpenPayments

And perhaps the still further step toward understanding the $4.2 million would be to examine the characteristics of the above drug companies which have been involving Dr Buadi in their payments — starting with the mega-donor Novartis.


Novartis is #1 of the six Buadi-Involved Drug Companies

  Novartis logo
You are here

From the very beginning of researching Novartis, it becomes evident that it is a criminal enterprise which blankets the globe, as for example in the seven countries: (1) United States, (2) China, (3) Greece, (4) Italy, (5) Japan, (6) Korea, and (7) Turkey (the list starting with the United States because it is most relevant, and continuing through the six other countries in alphabetical order).

Click flag to read more.

1
United States
Flag United States
New York Times




CNN politics



France24.com
30Sep2010




10May2018



16May2018
Novartis Pays $422.5 Million in Settlement
The government accused Novartis of paying illegal kickbacks to health care professionals through speaker programs, advisory boards, entertainment, travel and meals.
Senator calls for investigation of Novartis
I have rarely seen something this gross.  Something like this didn't happen in either the Bush or the Obama administrations.
Novartis lawyer steps down over Trump lawyer payment
On May 9, Novartis said it had signed a one-year contract for $100,000 a month with the firm in February 2017, seeking advice on the new administration's public health policy.
2
China
Flag China
Ropes & Gray 04Apr2016 Novartis Agrees to Settle Bribery Charges Against
Chinese Subsidiaries for $25 Million

According to the SEC administrative order, these Chinese-based business units obscured corrupt payments by instead identifying them as legitimate expenses for conferences, lecture fees, marketing events, education seminars, and medical studies.
3
Greece
Flag Greece
The BMJ





The Guardian
09Jan2017





22Feb2018
Novartis is under investigation for allegedly bribing
thousands of Greek doctors

Greece’s investigation, ordered by the country’s supreme court prosecutor, was announced by the government after intense media speculation following a public suicide attempt on New Year’s Day by a Greek Novartis executive.
Novartis Bribery Claims: Greek MPs Vote to
Investigate Top Politicians

Officials in Tsipras’ leftist-led administration have described the alleged bribery scandal as the worst since the creation of the modern Greek state almost 200 years ago.
4
Italy
Flag Italy
APMHealthEurope 01Dec2017 Novartis, Roche CEOs in Italy facing prosecution over
secret pact to prevent Avastin use in ophthalmology

Pesci has decided to proceed with the case on the grounds that there is evidence of a secret agreement to ensure Lucentis (ranibizumab), which cost 900 euros, was bought rather than Avastin (bevacizumab) whose off-label use in ophthalmology cost just 80 euros.
5
Japan
Flag Japan
AAPS 08Jul2014 Novartis Faces Criminal Charges in Japan Diovan Scandal
Last month, Shirahashi was detained for questioning and then recently re-arrested only days ago as more evidence emerged to link him to the falsified test results.
6
Korea
Flag Korea
Ropes & Gray 01May2017 South Korea Fines Prominent Pharmaceutical
Manufacturer in Latest Anti-Corruption Enforcement Efforts

Korean authorities allege that between 2011 and 2016, Novartis paid around $2.3 million in bribes to physicians, in the guise of funding of academic events, whereby Novartis would arrange for a scientific journal to host medical symposia and then would make cash "travel expense" payments to participating doctors.
7
Turkey
Flag Turkey
Reuters 29Mar2016 Exclusive: Novartis investigating $85 million bribery
allegations in Turkey

The biggest gain of $50 million, according to the whistleblower’s email, came from Turkish officials allowing Novartis to rename its drugs Ilaris and Gilenya as Ibecta and Fingya. This meant they dropped out of international pricing comparisons, since such cross-referencing is based on commercial names.

Although the remaining five Buadi-involved drug companies beyond Novartis account for a much smaller proportion of the total OpenPayments in which he is involved, it might nevertheless prove informative to see if any of them exhibit a predisposition toward lawbreaking as strong as that of Novartis.  In view of the weaker relevance of the remaining five drug companies, evidence will be limited to one usually-short excerpt describing a single scandal per drug company, though many scandals could be cited as was done for Novartis immediately above.


GlaxoSmithKline is #2 of the six Buadi-Involved Drug Companies

US Department of Justice Seal
Department of Justice      Office of Public Affairs      02Jul2012      justice.gov

GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data

Largest Health Care Fraud Settlement in U.S. History

Global health care giant GlaxoSmithKline LLC (GSK) agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices, the Justice Department announced today.  The resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.  [...]

"Today’s multi-billion dollar settlement is unprecedented in both size and scope.  It underscores the Administration’s firm commitment to protecting the American people and holding accountable those who commit health care fraud," said James M. Cole, Deputy Attorney General.  "At every level, we are determined to stop practices that jeopardize patients’ health, harm taxpayers, and violate the public trust — and this historic action is a clear warning to any company that chooses to break the law."  [...]



Amgen is #3 of the six Buadi-Involved Drug Companies

US Department of Justice seal
19Dec2012       justice.gov

Amgen Inc. Pleads Guilty to Federal Charge in Brooklyn, NY;  Pays $762 Million to Resolve Criminal Liability and False Claims Act Allegations

Biotech Giant Pleads Guilty to Illegally Introducing Drug into Market for Uses That the FDA Declined to Approve;  Will Pay $612 Million to Resolve False Claims Act Suits and $150 Million in Criminal Penalties and Forfeiture Amerisourcebergen

Earlier today, at the federal courthouse in Brooklyn, New York, U.S. District Judge Sterling Johnson, Jr. accepted a guilty plea by American biotechnology giant Amgen Inc. (Amgen) for illegally introducing a misbranded drug into interstate commerce.  The plea is part of a global settlement with the United States in which Amgen agreed to pay $762 million to resolve criminal and civil liability arising from its sale and promotion of certain drugs.  The settlement represents the single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history.  [...]

As part of the plea agreement and criminal settlement, Amgen entered a guilty plea yesterday before U.S. District Judge Sterling Johnson of the Eastern District of New York to a criminal information charging the company with illegally introducing a misbranded drug, Aranesp, into interstate commerce.  [...]  In order to increase sales of Aranesp and reap the resulting profits, Amgen illegally sold the drug with the intention that it be used at off-label doses that the FDA had specifically considered and rejected, and for an off-label treatment that the FDA had never approved.  Under the terms of the criminal plea agreement, Amgen will pay a criminal fine of $136 million and criminal forfeiture in the amount of $14 million.

As part of the civil settlement, Amgen has agreed to pay $612 million [...] to resolve claims that it caused false claims to be submitted to Medicare, Medicaid and other government insurance programs.  The federal civil settlement agreement encompasses allegations that Amgen: (1) promoted Aranesp and two other drugs that it manufactured, Enbrel and Neulasta, for off-label uses and doses that were not approved by the FDA and not properly reimbursable by federal insurance programs; (2) offered illegal kickbacks to a wide range of entities in an effort to influence health care providers to select its products for use, regardless of whether they were reimbursable by federal health care programs or were medically necessary; and (3) engaged in false price reporting practices involving several of its drugs.  [...]

"Today’s resolution reinforces the Department of Justice’s commitment to cracking down on unlawful conduct by pharmaceutical companies," said Civil Division Principal Deputy Assistant Attorney General Delery.  "When drug companies improperly misbrand their products, they not only could put individual patients at risk, but they also undermine the federal health care system that protects all of us."

"Instead of working to extend and enhance human lives, Amgen illegally pursued corporate profits while jeopardizing the safety of vulnerable consumers suffering from disease.  Americans expect — and the law requires — much more [...]," said Acting U.S. Attorney of the Eastern District of New York Miller.  [...]

"Promoting drugs for unapproved purposes is beyond wrong; it jeopardizes the health and safety of the public," said FBI Assistant Director Venizelos.  "Preserving the integrity of the pharmaceutical industry is important work, and the FBI will continue working with our colleagues in law enforcement to investigate and charge those who inappropriately market drugs for scurrilous profits."  [...]



Millenium is #4 of the six Buadi-Involved Drug Companies

US Department of Justice Seal
Department of Justice      Office of Public Affairs      19Oct2015      justice.gov

Millennium Health Agrees to Pay $256 Million to Resolve Allegations of Unnecessary Drug and Genetic Testing and Illegal Remuneration to Physicians

Millennium Health, formerly Millennium Laboratories, has agreed to pay $256 million to resolve alleged violations of the False Claims Act for billing Medicare, Medicaid and other federal health care programs for medically unnecessary urine drug and genetic testing and for providing free items to physicians who agreed to refer expensive laboratory testing business to Millennium, the Justice Department announced today.  Millennium, headquartered in San Diego, is one of the largest urine drug testing laboratories in the United States and conducts business nationwide.

"The Department of Justice is committed to ensuring that laboratory tests, including drug and genetic tests, are ordered based on each patient’s medical needs and not just to increase physician and laboratory profits," said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division.  "We will not tolerate practices such as the ordering of excessive, non-patient specific tests and the provision of inducements to physicians that lead to unnecessary costs being imposed upon our nation’s health care programs."  [...]



Pfizer is #5 of the six Buadi-Involved Drug Companies

New York Times label
Pfizer Pays $2.3 Billion to Settle Marketing Case
By GARDINER HARRIS       02Sep2009       nytimes.com

WASHINGTON — The pharmaceutical giant Pfizer agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed its painkiller Bextra, which has been withdrawn.

It was the largest health care fraud settlement and the largest criminal fine of any kind ever.  [...]

"Among the factors we considered in calibrating this severe punishment was Pfizer’s recidivism," said Michael K. Loucks, acting United States attorney for the Massachusetts district.

Amy W. Schulman, Pfizer’s general counsel, said that Pfizer had reformed — again.  [...]

The government charged that executives and sales representatives throughout Pfizer’s ranks planned and executed schemes to illegally market not only Bextra but also Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, which treats nerve pain.  While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales.  [...]



Celgene is #6 of the six Buadi-Involved Drug Companies

USA Today logo

Celgene settles whistleblower suit for $280M over fraudulent use of Thalomid

Brian Melley, The Associated Press    26Jul2017    usatoday.com

LOS ANGELES — Celgene Corp. has agreed to pay $280 million to settle a whistleblower lawsuit alleging the pharmaceutical company committed fraud promoting a drug with a notorious history that was re-purposed to treat leprosy and another therapy for unapproved cancer treatments, federal prosecutors announced Tuesday.  [...]

Thalomid, another name for thalidomide, a drug prescribed for morning sickness in the 1950s and 1960s that caused severe birth defects, was approved by the agency in 1998 for treating leprosy.

Because Thalomid would only be useful to a fraction of the few hundred leprosy cases diagnosed in the U.S. each year, the company developed a plan to promote the drug for cancer, the lawsuit said.  [...]

The FDA contacted Celgene and sent letters warning about its promotional efforts and for failing to warn about potential fatal risks from the toxic drugs, the lawsuit said.

"Their use in off-label indications was tantamount to human experimentation," Brown's lawyers wrote in one court filing.  "Celgene compounded this by instructing its sales representatives to conceal the drugs' risks, including most notably the potential for lethal blood clots."  [...]

To sum up, what we have learned about Dr Buadi so far is that he has some involvement in OpenPayments approaching $4.2 million, and that all six of the drug companies who make Buadi-involving payments seem deeply mired in all manner of lawbreaking.


Dr Buadi is Not Alone

Dr Buadi is not alone in that many other Mayo physicians enjoy involvement in OpenPayments totalling in the millions, as for example the three additional physicians below who were stumbled upon rather than being products of a search for physicians involved in particularly-high OpenPayments.  A dedicated search for physicians with high OpenPayments Totals would certainly turn up a much larger number of physicians.

My limited resources do not allow me to investigate all the drug companies whose OpenPayments involved the three new doctors below, but I can perform that investigation for each of the three new physicians for their highest-paying top two drug companies, and which, as in Dr Buadi's case, can be expected to cover the vast majority of each doctor's OpenPayments.

Four Mayo Physicians involved in
Multi-Million-Dollar OpenPayments Totals

Aug2013-Dec2016

Clicking a Drug-Company-Wrongdoing Icon Icon by Freepik www.flaticon.com below takes the reader to evidence of the wrongdoing of that Icon's accompanying drug company, to return from which evidence takes only a click of your browser's Back-To-Previous-View button.  The Wrongdoing-Icon is by Freepik www.flaticon.com.

MAYO
PHYSICIAN
OPENPAYMENTS
TOTAL
BIGGEST
DONOR
2nd-BIGGEST
DONOR
3rd-BIGGEST
DONOR
4th-BIGGEST
DONOR
5th-BIGGEST
DONOR
6th-BIGGEST
DONOR
Francis Buadi
Mayo Clinic
Rochester MN
$   4,197,570 Novartis
Icon by Freepik www.flaticon.com
GlaxoSmithKline
Icon by Freepik www.flaticon.com
Amgen
Icon by Freepik www.flaticon.com
Millenium
Icon by Freepik www.flaticon.com
Pfizer
Icon by Freepik www.flaticon.com
Celgene
Icon by Freepik www.flaticon.com
Axel Grothey
Mayo Clinic
Rochester MN
$   4,497,465 Bayer
Icon by Freepik www.flaticon.com
AstraZeneca
Icon by Freepik www.flaticon.com
       
Sikander Ailawadhi
Mayo Clinic
Jacksonville FL
$   9,796,512 Amgen
Icon by Freepik www.flaticon.com
Novartis
Icon by Freepik www.flaticon.com
       
Shaji Kumar
Mayo Clinic
Rochester MN
$ 11,198,849 Novartis
Icon by Freepik www.flaticon.com
Millenium
Icon by Freepik www.flaticon.com
       

The only Drug Companies in the table above whose misconduct has not yet been illustrated are the two which involve Dr Axel Grothey — Bayer and AstraZeneca — so let's take a quick look at them right now, limiting ourselves in each case to a short excerpt concerning a single scandal.


Bayer is #1 of the two top-paying Grothey-Involved Drug Companies

Bad Blood Cautionary Tale  
PBS logo  

"A haunting film.  Our entire public health system failed the hemophiliac community.  It is unconscionable when we had the science we failed to protect our fellow citizens."   Donna E. Shalala, Former Secretary of Health and Human Services

What if your life-saving medicine contained deadly viruses — and the drug manufacturers, the government, and your own doctors knew, but failed to warn you?

In the 1960s, a new treatment derived from human blood transformed the often-fatal genetic disease hemophilia into a treatable chronic condition.  This "miracle" product was approved by the FDA despite the known risk of viral contamination — including hepatitis.  Even as AIDS breached the nation's blood supply in the early 1980s, hemophiliacs were advised by their doctors to keep using the drug believing the benefits outweighed the risks.  By the time the medication was pulled from the market in 1985, 10,000 hemophiliacs had been infected with HIV, and 15,000 with hepatitis, causing the worst medical disaster in U.S. history.     Trailer for PBS documentary

Remember the hemophilia holocaust



AstraZeneca is #2 of the two top-paying Grothey-Involved Drug Companies

ABC News logo

Drug Giant AstraZeneca to Pay $520 Million to Settle Fraud Case
By HUMA KHAN and PIERRE THOMAS       27Apr2010       abcnews.go.com

Pharmaceutical giant AstraZeneca will pay $520 million in fines to settle charges by the federal government that it illegally marketed the anti-psychotic drug Seroquel to children and elderly patients for uses not approved by the Food and Drug Administration.

AstraZeneca, one of the country's biggest drug firms, allegedly pulled in hundreds of millions of taxpayer dollars through Medicare and Medicaid kickbacks and scams.  Seroquel is used to treat schizophrenia in patients older than 13, and bipolar disorder in patients older than 10.

The FDA approved Seroquel to treat only psychotic disorders, specifically short-term treatments of schizophrenia, bipolar mania and bipolar depression.  The government claims that AstraZeneca intentionally marketed the drugs — by paying kickbacks to doctors — for a variety of illnesses for which it had never been tested, including aggression, Alzheimer's, anger management, anxiety, attention-deficit hyperactivity disorder, dementia, depression, mood disorder, post-traumatic stress disorder and sleeplessness.  It was given to the elderly, children, veterans and inmates, who were treated as "guinea pigs," according to the acting U.S. attorney for the Eastern District of Pennsylvania.  [...]

This is not the first case of such abuse and it's unlikely to be the last because the settlements are usually "chump change" for such firms, said John Abramson, clinical instructor at Harvard Medical School and author of "Overdo$ed America:  The Broken Promise of American Medicine."  [...]

To sum up the evidence on the four Mayo physicians (Buadi, Grothey, Ailawadhi, and Kumar) who have been noticed involving themselves in millions of dollars of drug-company payments:  all six of the drug-companies which involve Dr Buadi in their payments, and the top two drug companies of each of the remaining three OpenPayments-involved physicians are profoundly scofflaw.

As there is overlap in the drug companies examined so far, they number only eight: Amgen, AstraZeneca, Bayer, Celgene, GlaxoSmithKline, Millenium, Novartis, and Pfizer.


THE MAYO CLINIC ITSELF IS INVOLVED IN
DRUG-INDUSTRY AND MEDICAL-DEVICE INDUSTRY
PAYMENTS


And what about OpenPayments involving not only individual doctors at the Mayo Clinic, but involving the Clinic itself?  The data immediately below speaks for itself, and incidentally brings to our attention the startling discovery that two of the physicians that we have noted above — Sikander Ailawadhi and Shaji Kumar — are involved in larger sums of OpenPayment money transfers than is the entire Mayo Clinic Rochester (Saint Marys Hospital and Rochester Methodist Hospital combined).

Mayo Clinic logo
Mayo Clinic, Saint Marys Campus Mayo Clinic Methodist Hospital
MAYO CLINIC
SAINT MARYS HOSPITAL
1216 Second Street SW
Rochester, MN 55905
MAYO CLINIC
METHODIST HOSPITAL
201 West Center Street
Rochester, MN 55902
2016
General Pay    $1,116,664
Research Pay   $4,100,396
2016
General Pay    $191,654
Research Pay   $161,962
2015
General Pay    $474,454
Research Pay   $144,277
2015
General Pay    $591,131
Research Pay   $219,571
2014
General Pay    $462,412
Research Pay   $107,835
2014
General Pay    $352,607
Research Pay   $115,313
2013 (Aug-Dec)
General Pay      $18,353
Research Pay   $302,822
2013 (Aug-Dec)
General Pay    $579,646
Research Pay   $176,758
Saint Marys Hospital had some involvement in
medicinal-company payments
Aug2013-Dec2016
and totalling

$6,727,213
as downloaded 25Dec2017 from
openpaymentsdata.cms
Rochester Methodist Hospital had some involvement in
medicinal-company payments
Aug2013-Dec2016
and totalling

$2,388,642
as downloaded 25Dec2017 from
openpaymentsdata.cms
OpenPayments Total
involving The Mayo Clinic
Aug2013-Dec2016
and totalling

$9,115,855
as downloaded 25Dec2017
Caution!
The transparency display of transactions from applicable manufacturers and group purchasing organizations to physicians and teaching hospitals does not necessarily mean any of the reported financial relationships are improper.  openpaymentsdata.cms.gov/
Sharing information about financial relationships alone is not enough to decide whether they’re beneficial or improper. Just because there are financial ties doesn’t mean that anyone is doing anything wrong.  cms.gov/OpenPayments
If you are a physician who served as a principal investigator on a research study, you may see the payments associated with that research study listed under your name.  This does not necessarily mean the payments are attributed to you.  FAQ #12224  cms.gov/OpenPayments

Furthermore, during Aug2013-Dec2016 the top two drug companies involving the Mayo Clinic in payment transfers are ones we haven't yet encountered:

#1     First, E.R. Squibb & Sons (a completely-owned subsidiary of Bristol-Myers Squibb) whose OpenPayments involving the Mayo Clinic total  $2,189,547.45
Bristol-Myers Squibb logo
#2     Second, Merck whose OpenPayments involving the Mayo Clinic total  $1,682,284.64    Merck logo

And it behooves us to now ask about Squibb and Merck what we have already asked about the eight other drug companies that we have encountered above — whether they are principled or scofflaw, truthful or mendacious, beneficial or harmful, focussed on patient welfare or on company profits?


Squibb is #1 of the two top-paying Mayo-Clinic-Involved Drug Companies

  Bristol-Myers Squibb logo
You are here

In answer to which questions concerning Squibb can be offered the seven descriptions below.



Click icons below to see more.

1
SEC.GOV
US Securities and Exchange Commission seal
SEC.GOV 04Aug2004 Bristol-Myers Squibb Company Agrees to Pay $150 Million to Settle Fraud Charges
Stephen M. Cutler, Director of the SEC's Division of Enforcement, said, "Bristol-Myers' earnings management scheme distorted the true performance of the company and its medicines business on a massive scale and caused significant harm to the company's shareholders".
2
USDOJ
US Department of Justice seal
USDOJ 28Sep2007 Bristol-Myers Squibb to Pay More Than $515 Million to Resolve Allegations of Illegal Drug Marketing and Pricing
"Kickbacks are especially nefarious when they are used as part of a marketing effort to convince physicians to prescribe drugs for uses that the Food and Drug Administration has not determined to be safe and effective."
3
USDOJ
US Department of Justice seal
USDOJ 06Apr2009 Former Bristol-Myers Squibb Senior Executive Pleads Guilty for Role in Dishonest Dealings with the Federal Government
"Those who attempt to mislead the federal government or undermine the integrity of its functions should expect to face criminal prosecution."
4
20 Years
Community Catalyst logo
Community
Catalyst
21Feb2014 Crime Pays for Drug Companies
To put an end to illegal off-label marketing, we need to make the drug company executives feel the same pain as the patients they’re afflicting.
5
volkovlaw.com
VOLKOVLAW.COM logo
VOLKOV 11Oct2015 Four Clear Messages from Bristol-Myers Squibb FCPA Enforcement Action
Healthcare professionals ("HCPs") demand gifts, cash, gift cards, conference sponsorships, speaking fees, and other benefits in exchange for prescriptions.
6
statnews.com
STAT 19Jul2016 Bristol-Myers pays $30 million to settle kickback charges
Last month, two former sales employees at Insys Therapeutics were indicted for allegedly paying doctors to participate in sham educational programs designed to boost prescriptions of Subsys, an addictive opioid painkiller.
7
mass.gov
Attorney General Massachusetts seal
Attorney General
Massachusetts
08Dec2016 Bristol-Myers Squibb to Pay $19.5 Million for Alleged Improper Drug Marketing to Encourage Prescriptions to Children, Elderly
BMS promoted Abilify for use in elderly patients with symptoms consistent with dementia and Alzheimer’s disease, despite the lack of FDA approval for these uses, and without first establishing the drug’s safety and efficacy for those uses.


Merck is #2 of the two top-paying Mayo-Clinic-involved Drug Companies

  MERC logo
You are here

In answer to which questions concerning Merck can be offered excerpts from the two articles below.  The punch that may be lost by citing only two instances is more than compensated by the number of fatalities attributed.

Click icons below to see more.

1
CBS News
CBS
NEWS
19Apr2011 At Merck, an Undercover Video and 40 Deaths Plague Nuvaring Birth Control Brand
About 40 women have died using Merck (MRK)'s Nuvaring contraceptive device, according to a Swiss report, as the company faces 730 lawsuits in U.S. courts.
2
The Week
THE
WEEK
27Apr2012 When half a million Americans died and nobody noticed
Perhaps 500,000 or more premature American deaths may have resulted from Vioxx. The inescapable conclusion is that in today's world and in the opinion of our own media, American lives are quite cheap, unlike those in China.


THREE PATHS FOR MAYO TO CHOOSE FROM


Path #1.  No Response From Mayo:  Business As Usual

Continuing to pursue profit at the expense of patient welfare is in the interests neither of patients nor of the Mayo Clinic.


Path #2.  A Weak Response From Mayo:  Full Disclosure To All Patients

Full disclosure is the minimum that patients have a right to expect; however, it is too little.  The scene to be feared is doctors accepting drug-company payments, but when forced to disclose would allay their patients' apprehensions by telling them that the money had gone toward education and research.  This would not be progress, it would be a barely-discernible variation of business as usual.


Path #3.  A Strong Response From Mayo:  Weaning Off The Big Pharma Udder

I had noticed in Dec2017 that five of the USNews top ten adult cancer centers (Mayo ranked #3) were thriving despite receiving zero drug-company payments (during Aug2013-Dec2016).  The five abstainers are shown below, and of course Mayo is not among them.  However, it may be the case that Mayo joining this group of rather elite abstainers, will not stop it from continuing to thrive, just as it does not stop the five from continuing to thrive.  It might be expected, rather, that patients will seek Mayo treatment all the more because they will have assurance that Mayo doctors have been purged of bias.

U.S.News & World Report logo
#1 
adult cancer hospital

Best Hospitals ranking by US News
#2 
adult cancer hospital

Best Hospitals ranking by US News
#5 
adult cancer hospital

Best Hospitals ranking by US News
#6 
adult cancer hospital

Best Hospitals ranking by US News
#9 
adult cancer hospital

Best Hospitals ranking by US News

MD Anderson logo

Memorial Sloan Kettering logo


Seattle Cancer Care Alliance logo
Johns Hopkins Hospital logo Moffit Cancer Center logo
University of Texas
MD Anderson Cancer Center

Houston, TX 77030-4000
Memorial Sloan Kettering
Cancer Center

New York, NY 10065-6007
Seattle Cancer Alliance/University of Washington Medical Center
Seattle, WA 98109-4405
Johns Hopkins Hospital


Baltimore, MD 21205-1832
Moffitt Cancer Center and Research Institute

Tampa, FL 33612-9497
Big Pharma disclosure of payments to MD Anderson Cancer Center Zero

Big Pharma disclosure of payments to Memorial Sloane Kettering Zero

Big Pharma disclosure of payments to Seattle Cancer Alliance Zero

Big Pharma disclosure of payments to Johns Hopkins Hospital Zero

Big Pharma disclosure of payments to MOFFITT CANCER CENTER Zero



WRAP-UP PART 1

So far, then, we have encountered four Mayo physicians each involved (in some arcane way impossible to fathom) in millions of dollars of drug company payments which we are able to glimpse in OpenPayments.

And we have noticed that the Mayo Clinic itself is similarly involved.

And among the drug companies making these payments, the ten shown below stand out.

And when we began to read about these ten drug companies, we discovered that every one of them had been guilty of egregious and repeated malpractice — so egregious and so repeated as to invoke a penalty of $3 billion in one instance, or so as to cost half a million American lives in another.

William James Mayo (1861-1939) 1  Amgen Paid $762 million to resolve criminal liability
2  AstraZeneca Paid $520 million to settle fraud case
3  Bayer Caused worst medical disaster in U.S. history
4  Celgene Paid $280M over fraudulent use of Thalomid
5  GlaxoSmithKline   Paid $3 billion to resolve fraud allegations
6  Merck Half a million Americans died
7  Millenium Paid $256 million for unnecessary testing and bribery
8  Novartis Paid $422.5 million for illegal kickbacks
9  Pfizer Paid $2.3 billion for illegal marketing
  10  Squibb Paid $515 million for illegal drug marketing

But, it may be argued, however odious the drug companies may be, and however indiscreet it may be for the Mayo Clinic or for Mayo doctors to have entered into such close collaboration with drug company money transfers, no wrongdoing has been proven on the part of Mayo — not on the part of its leadership and not on the part of its physicians.  Most of those millions of dollars which flow from the drug companies — argues this defense — support solid and invaluable medical research, and scientific understanding is advanced whether supported by clean money or by money that some may choose to consider tainted.

This defense may be valid, and needs to be tested, as will be done in OUR VISIT TO MAYO, PART 2, THE TWO-STEP QUICK QUALITY QUIZ.

But in the meantime, does anyone doubt what Dr William James Mayo would do were he to reappear in Rochester and see what goes on in the clinic which bears his family's name?

Jesus drives the money changers out of the temple

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