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 PAUL RICHARDSON:
WHO CAN A CANCER PATIENT TRUST?

by Semmel Weis
First published 31Jan2018  Last edited 11Sep2018  12:34pm



TRUST EXPERTS, CLINICS, SOCIETIES?

Searching for help following a diagnosis of myeloma turns up much material, such as the following, inviting trust in leading experts, in the prestigious hospitals/clinics in which they practice, and in cancer societies:

Dr. Joseph Mikhael Joins the International Myeloma Foundation as Chief Medical Officer
World-renowned myeloma expert to contribute to leading myeloma organization
International Myeloma Foundation logo

NORTH HOLLYWOOD, Calif., Jan. 22, 2018   PRNewswire-USNewswire
The International Myeloma Foundation (IMF) — improving the quality of life of myeloma patients while working toward prevention and a cure — is pleased to announce that myeloma expert Dr. Joseph Mikhael has joined the IMF as Chief Medical Officer.  He will be working closely with the IMF's Chair of the Board, Dr. Brian Durie, to advance the mission of the organization in research, education, advocacy and patient care to improve lives of patients with multiple myeloma.  [...]

Having been a professor of medicine at Mayo Clinic and a world-renowned expert in myeloma, Dr. Mikhael brings a wealth of this experience to this new role.  He has conducted dozens of clinical trials in the field of myeloma and has contributed to the development of many novel drugs.  He also served as the Associate Dean of Graduate Medical Education and the Deputy Director of the Mayo Clinic Comprehensive Cancer Center.  [...]


Joseph Mikhael is Chief Medical Officer of the International Myeloma Foundation
Joseph Mikhael, MD, MEd, FRCPC, FACP,
Chief Medical Officer,
International Myeloma Foundation

However, looking up in OpenPayments the doctors mentioned above (Drs Brian Durie and Joseph Mikhael), along with the hospitals/clinics in which they practice or recently practiced (Cedars-Sinai Medical Center and Mayo Clinic Arizona), discovers that both experts and medical facilities have been involved in drug-company dollar transfers:

Brian Durie, Chair of Board of the International Myeloma Foundation (IMF)
Dr BRIAN DURIE
Cedars-Sinai Medical Center
Los Angeles CA
Cedars-Sinai Medical Center logo


CEDARS-SINAI MEDICAL CENTER

Los Angeles CA
Dr Joseph Mikhael of the Mayo Clinic Phoenix
Dr JOSEPH MIKHAEL
Mayo Clinic Arizona
Phoenix AZ
Mayo Clinic logo
MAYO CLINIC ARIZONA

Phoenix AZ
2016
General Payments     $27,977
Research Payments     $3,986
Associated Research  $44,541
2016
General Payments  $26,475,576 Research Payments  $8,911,243
2016
General Payments         $93,472
Research Payments       $27,768
Associated Research  $1,139,566
2016
General Payments    $1,073,570
Research Payments  $4,979,402
2015
General Payments       $17,001
Research Payments       $3,342
Associated Research  $369,699
2015
General Payments    $5,757,686
Research Payments  $8,920,398
2015
General Payments       $25,762
Research Payments       $5,861
Associated Research  $783,159
2015
General Payments    $1,044,730
Research Payments  $7,649,477
2014
General Payments       $13,711
Research Payments     $10,831
Associated Research  $193,479
2014
General Payments      $7,467,511
Research Payments  $10,169,085
2014
General Payments       $13,399
Research Payments       $2,562
Associated Research  $278,158
2014
General Payments    $1,108,564
Research Payments  $5,052,395
2013 (Aug-Dec)
General Payments         $2,027
Research Payments         N/A
Associated Research  $772,520
2013 (Aug-Dec)
General Payments    $4,076,495
Research Payments  $4,816,038
2013 (Aug-Dec)
General Payments       $10,058
Research Payments       $2,270
Associated Research  $209,512
2013 (Aug-Dec)
General Payments       $300,907
Research Payments  $2,762,687
Each involvement total below is the sum of dollar amounts in the column above
Dr Brian Durie
has been involved
in drug-company
OpenPayments
covering Aug2013-Dec2016
and totalling

$1,459,114
as downloaded Jan2018 from
openpaymentsdata.cms.gov
Cedars-Sinai Medical Center
has been involved
in drug-company
OpenPayments
covering Aug2013-Dec2016
and totalling

$76,594,032
as downloaded Jan2018 from
openpaymentsdata.cms.gov
Dr Joseph Mikhael
has been involved
in drug-company
OpenPayments
covering Aug2013-Dec2016
and totalling

$2,591,547
as downloaded Jan2018 from
openpaymentsdata.cms.gov
Mayo Clinic Arizona
has been involved
in drug-company
OpenPayments
covering Aug2013-Dec2016
and totalling

$23,971,732
as downloaded Jan2018 from
openpaymentsdata.cms.gov
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

OpenPayments does not monitor payments to societies such as the International Myeloma Foundation (IMF), but from the expression of gratitude on the IMF web site, it looks like payments are being made, and perhaps are indispensable to IMF survival:

We would like to thank:

Amgen, Astellas Pharma, Binding Site, Bristol-Myers Squibb, Celgene, Diplomat Pharmacy, Genentech, Hoffman-La Roche, Janssen, Karyopharm Therapeutics, Merck, Novartis, Oncopeptides, Sanofi-Genzyme, Takeda Oncology

International Myeloma Foundation

The cancer patient may be excused if he begins to feel that where he expects to hear expert medical advice, what he gets instead, and from all directions, is nothing better that a sales pitch scripted at a drug-company head office.  Such fear is not allayed by the pseudo-disclosure immediately above consisting of the IMF publicly thanking drug companies, but without disclosing the value of their receipts, or what reciprocity the gifts entailed — as if such considerations were a private matter between drug companies and IMF, and as if conflict of interest were not a legitimate concern of someone with cancer being advised to undergo the chemotherapy being sold by the drug company writing the checks.

A more general statement on drug-company infiltration of patient-advocacy groups is made by Georgetown University's Dr Adriane Fugh-Berman of PharmedOUT.ORG:

Bloomberg BNA logo            PharmedOUT.ORG

Very Few Patient Groups Don’t Take Pharma Money

by Dana Elfin     Dana Elfin    20Oct2017     bna.com

Most patient and consumer advocacy groups receive funds from the pharmaceutical industry, according to a new study released by the group PharmedOut.

Only a handful out of 7,685 health advocacy groups in the U.S. are completely independent of pharmaceutical industry money, according to a list the group released Oct. 13.  PharmedOut is a Georgetown University Medical Center project that advances evidence-based prescribing and educates health-care professionals about pharmaceutical marketing practices.

And industry funding of patient groups, including websites and informational materials, is often not apparent to the average consumer, which could mislead consumers into believing they’re getting unbiased health advice.

"Industry funding is often not disclosed on websites or informational materials or is hidden," PharmedOut Director Adriane Fugh-Berman told me in an Oct. 16 phone call.  Funding and sponsorship is often very subtle and difficult to identify, she said.

In addition, she said, industry sponsorship can affect the stands patient and consumer groups are willing to take, she said.

Groups that accept industry funding are affected by that money, regardless of whether they think they are, she said.

"Look at the stands taken and not taken," she said. “For example, where is the anger and outrage about drug costs?"

Fugh-Berman is an associate professor in the Department of Pharmacology and Physiology and in the Department of Family Medicine at Georgetown University Medical Center.  [...]



TRUST FACULTY MEMBERS AT UNIVERSITIES, THEN?

The following is not a recent report, but perhaps the picture it paints has not changed much because the corrective measures implemented or contemplated in the report seem more likely to drive the flow of payments into the shadows than to stop them.

New York Times logo Harvard Medical School in Ethics Quandary

Group of Harvard Medical Students object to drug companies interfering in medical education
Harvard Medical School students like (from the left) Kirsten Austad, Lekshmi Santhosh, Kim Sue and David Tian, members of the American Medical Student Association, object to the influence of drug companies in the school’s educational curriculum.

By DUFF WILSON
Published: March 2, 2009    NYTIMES

BOSTON — In a first-year pharmacology class at Harvard Medical School, Matt Zerden grew wary as the professor promoted the benefits of cholesterol drugs and seemed to belittle a student who asked about side effects.

Mr. Zerden later discovered something by searching online that he began sharing with his classmates.  The professor was not only a full-time member of the Harvard Medical faculty, but a paid consultant to 10 drug companies, including five makers of cholesterol treatments.

"I felt really violated," Mr. Zerden, now a fourth-year student, recently recalled.  "Here we have 160 open minds trying to learn the basics in a protected space, and the information he was giving wasn’t as pure as I think it should be."

Mr. Zerden’s minor stir four years ago has lately grown into a full-blown movement by more than 200 Harvard Medical School students and sympathetic faculty, intent on exposing and curtailing the industry influence in their classrooms and laboratories, as well as in Harvard’s 17 affiliated teaching hospitals and institutes.

They say they are concerned that the same money that helped build the school’s world-class status may in fact be hurting its reputation and affecting its teaching.

The students argue, for example, that Harvard should be embarrassed by the F grade it recently received from the American Medical Student Association, a national group that rates how well medical schools monitor and control drug industry money.

Harvard Medical School’s peers received much higher grades, ranging from the A for the University of Pennsylvania, to B’s received by Stanford, Columbia and New York University, to the C for Yale.

Harvard has fallen behind, some faculty and administrators say, because its teaching hospitals are not owned by the university, complicating reform; because the dean is fairly new and his predecessor was such an industry booster that he served on a pharmaceutical company board; and because a crackdown, simply put, could cost it money or faculty.  [...]

The Harvard students have already secured a requirement that all professors and lecturers disclose their industry ties in class — a blanket policy that has been adopted by no other leading medical school.  (One Harvard professor’s disclosure in class listed 47 company affiliations.)

"Harvard needs to live up to its name," said Kirsten Austad, 24, a first-year Harvard Medical student who is one of the movement’s leaders.  "We are really being indoctrinated into a field of medicine that is becoming more and more commercialized."

David Tian, 24, a first-year Harvard Medical student, said: "Before coming here, I had no idea how much influence companies had on medical education.  And it’s something that’s purposely meant to be under the table, providing information under the guise of education when that information is also presented for marketing purposes."

The students say they worry that pharmaceutical industry scandals in recent years — including some criminal convictions, billions of dollars in fines, proof of bias in research and publishing and false marketing claims — have cast a bad light on the medical profession.  And they criticize Harvard as being less vigilant than other leading medical schools in monitoring potential financial conflicts by faculty members.

Dr. Flier says that the Harvard Medical faculty may lead the nation in receiving money from industry, as well as government and charities, and he does not want to tighten the spigot.  [...]

But no one disputes that many individual Harvard Medical faculty members receive tens [of thousands] or even hundreds of thousands of dollars a year through industry consulting and speaking fees.  Under the school’s disclosure rules, about 1,600 of 8,900 professors and lecturers have reported to the dean that they or a family member had a financial interest in a business related to their teaching, research or clinical care.  The reports show 149 with financial ties to Pfizer and 130 with Merck.  [...]

Other blandishments include industry-endowed chairs like the three Harvard created with $8 million from sleep research companies; faculty prizes like the $50,000 award named after Bristol-Myers Squibb, and sponsorships like Pfizer’s $1 million annual subsidy for 20 new M.D.’s in a two-year program to learn clinical investigation and pursue Harvard Master of Medical Science degrees, including classes taught by Pfizer scientists.

Dr. Flier, who became dean 17 months ago, previously received a $500,000 research grant from Bristol-Myers Squibb.  He also consulted for three Cambridge biotechnology companies, but says that those relationships have ended and that he has accepted no new industry affiliations.

That is in contrast to his predecessor as dean, Dr. Joseph B. Martin.  Harvard’s rules allowed Dr. Martin to sit on the board of the medical products company Baxter International for 5 of the 10 years he led the medical school, supplementing his university salary with up to $197,000 a year from Baxter, according to company filings.  [...]

But Dr. Marcia Angell, a faculty member and former editor in chief of The New England Journal of Medicine, is among the professors who argue that industry profit motives do not correspond to the scientific aims of academic medicine and that much of the financing needs to be not only disclosed, but banned.  Too many medical schools, she says, have struck a "Faustian bargain" with pharmaceutical companies.

"If a school like Harvard can’t behave itself," Dr. Angell said, "who can?"


  Detail of Pharma payments to Dr Joseph Mikhael

Real progress in reducing conflict-of-interest in academia will be made when OpenPayments adds faculty members to the people it reports taking Pharma money, so that students can review a professor's pharma-payment income even before attending the first lecture, and can even try to correlate dates of individual payments with the professor's merchandizing activities.

Opposite is an example of the sort of detail that is available right now on the OpenPayments web site, this particular example being a breakdown of the $1,139,566 that is marked in yellow in the Dr JOSEPH MIKHAEL column in the OpenPayments table above, which is the total funding paid him in the category Associated Research in 2016, and which we now learn is the sum of the four dollar amounts opposite, starting with $817,357.23 which had been received from SANOFI US SERVICES INC.  In the lower-half of the image opposite can be seen the $1,139,566 beginning to be broken down into individual payments — specifically, the ten most recent 2016 individual payments in the Associated Research category.  In the bottom line of the image opposite can be seen that there are a total of six such pages, all six pages devoted to itemizing the individual payments which total $1,139,566.

This level of detail which OpenPayments presently publishes concerning practicing physicians needs to be extended to academicians, whether they have MDs or not.

Brings to mind the possibility that the reason doctors have poor training in scientific method is that Big Pharma prevents this subject from being taught except cursorily and superficially, in order to prevent doctors from acquiring the skill to recognize that many Big Pharma clinical trials are not scientific research but infomercials.  One way to prevent scientific method from being taught is to hand it over to Pharma to teach it, as seems to be alluded to in the New York Times article above where reference is made to "sponsorships like Pfizer’s $1 million annual subsidy for 20 new M.D.’s in a two-year program to learn clinical investigation and pursue Harvard Master of Medical Science degrees, including classes taught by Pfizer scientists."


TRUST THE PEER-REVIEWED PROFESSIONAL JOURNALS?

But if the cancer sufferer can't trust the eminent experts, or the acclaimed clinics in which they practice, or the patient-support cancer agencies, or the professors who teach at medical schools — then who is there left to trust?  Perhaps the researchers who publish in professional journals because they have to meet the high standards set by editors and peer reviewers?

However, with this approach there arises the same problem — that drug companies have co-opted the editorial leadership, as is detailed by Liu et al (2017) relying on the same OpenPayments source of data that has been relied on above.

Money for editors from Liu (2017)

BMJ logo
 

Payments by US pharmaceutical and medical device manufacturers to US medical journal editors: retrospective observational study

Jessica J Liu, Chaim M Bell, John J Matelski, Allan S Detsky, Peter Cram

BMJ 2017;359:j4619 at  doi.org/10.1136/bmj.j4619  and  www.bmj.com/content/359/bmj.j4619
Accepted 18 September 2017, Published 26 October 2017
Correspondence to: J J Liu Department of Medicine, Division of General Internal Medicine, University Health Network and Sinai Health System, Toronto, Ontario, Canada  jessica.liu@uhn.ca

Introduction

Journal editors play a crucial role in scientific discourse.  Editors triage new manuscript submissions and decide on those that warrant external review.  For manuscripts that undergo external assessment, editors typically synthesise comments and decide which papers will be published.  Based on concerns about lapses in integrity and unintentional bias associated with industry funding, authors are now required to comprehensively report financial relations with industry to editors early in the publication process.  However, compared with author conflict of interest, editorial conflict of interest has been infrequently studied.

For authors, publication in top tier journals plays a crucial role in obtaining grant funding and career advancement.  For industry, publication in high impact journals bestows academic prestige and global attention to research and may speed regulatory approval, boost sales, and increase stock price.  Journal editors wield enormous power; they are the individuals who determine a substantial amount of the content and conclusions of what appears in their journals, including article selection, article content, and which articles have accompanying editorials.  [...]

It is well recognised that pharmaceutical and medical device makers target physician "thought leaders" for lucrative consulting and advisory roles.  The rationale for such a strategy is that these leaders can influence both their physician peers and trainees to boost sales of products.  [...]

An internet search of one editor who received general payments of $10,981,153 in 2014 revealed that this individual founded a private company that was subsequently sold to an international medical device corporation in 2012.  Many of the key publications for this device were published in the same journal where the company physician founder served as an editor.  [...]  [W]e wonder whether such entrepreneurs should be allowed to serve as editors.  [...]

In summary, we found that a substantial percentage of journal editors received personal payments from industry and these payments were often large.  Journal editors should reconsider their conflict of interest policies and the impact that editor relations with industry may have on public trust in the research enterprise.

Liu (2017) collected data on 713 editors working on 52 influential medical journals based in the US, falling into 26 categories, some of her Table 2 data being presented below.  The Liu-presented payments are not directly comparable to the OpenPayments Totals presented at the top of the instant page, and elsewhere on semmel-weis.org, because our OpenPayments Totals cover three-years-five-months (whereas Liu covers only 2014), and because OpenPayments Totals include all three categories of payments (General Payments, Research Payments, and Associated Research Funding, the latter often by far the biggest), whereas Liu covers only General Payments.

General Payments To Individual Editors in 2014 (US$)
from Liu, Bell, Matelski, Detsky, and Cram (2017)
Journal specialty Top of
bottom quarter
(Q1)
Top of
bottom half
(Q2=Median)
Bottom of
top quarter
(Q3)
Top of
top quarter
(Highest payment
to individual editor)
Pathology 0 0 0 80
General internal medicine 0 0 18 795
Surgery 0 27 105 1,922
Paediatrics 0 0 0 2,600
Obstetrics and gynaecology 0 0 50 8,038
Geriatrics 0 0 30 11, 409
Family medicine 0 0 0 13,733
Psychiatry 0 0 6,394 20,600
Neurology 0 11 2,346 20, 887
Urology 90 490 669 26, 389
Nephrology 86 359 6,086 36, 479
Otolaryngology 42 172 2,204 50, 203
Oncology 0 11 811 57, 282
Radiology 0 0 178 77,366
High impact general medicine 0 0 14 78,617
Anaesthesiology 0 0 4,469 97,529
Dermatology 6 176 5,541 108, 590
Ophthalmology 0 115 4,392 119, 331
Emergency medicine 0 0 16 127,922
Critical care 0 55 9,093 207, 414
Gastroenterology 0 696 20, 002 214,053
Rheumatology 0 515 14, 280 355, 923
Infectious diseases 0 0 2,522 512, 421
Endocrinology 0 7,207 85, 816 554, 162
Orthopaedics 8 121 29, 344 1, 263, 234
Cardiology 0 2,664 12, 912 10,981,153

Drug companies control medical journals also by means of their advertising payments, as for example:

In January 1976 the New York Times ran a series of articles on medical incompetence, including the misuse of prescription drugs.  Retaliation in the form of cancellation of half a million dollars' worth of advertising in Modern Medicine, a journal owned by the Times company, was said to have been exacted.  The newspaper quoted an officer of the medical journal as saying that the companies cancelled their advertisements because they felt "you don't feed people who beat you up".     John Braithwaite, Corporate Crime in the Pharmaceutical Industry, Routledge Revivals, New York, 1984, p. 221.


TRUST POLITICIANS TO SET THINGS RIGHT?

The numbers speak for themselves:

OpenSecrets.org logo
OpenSecrets.org

OpenSecrets top pharmaceutical contributors to politicians

President Trump's nominating former Eli Lilly president Alex Azar for the job of top US health chief ignited opposition:

But in the end Azar was confirmed, raising the question whether Big Pharma's control of American politics has reached a historic high:

CNBC logo

Senate confirms former drug exec Alex Azar as Trump's health chief
Dan Mangan    24Jan2018    CNBC


The Senate confirmed the nomination of former drug company executive Alex Azar as head of the U.S. Health and Human Services Department on Wednesday.

Azar's long-expected approval as HHS secretary puts him in a charge of a department with a trillion-dollar budget that oversees the massive Medicare and Medicaid health coverage systems, drug regulatory bodies, disease-fighting agencies and the ever-controversial Obamacare health reform law.

The Senate voted 55-43 in favor of Azar's appointment.  [...]

In 2017, the Yale Law grad ended a five-year stint as president of the U.S. division of pharmaceuticals giant Eli Lilly and Co.

Democratic senators during Azar's recent confirmation hearings highlighted the price increases of Lily's drugs while he was at the company, and given that history were skeptical of his claims to intend to fight rising drug costs as HHS chief.

Azar is the first person with a pharmaceutical industry background to lead the health agency.  [...]


Cartoon: A Very Special Interest



OBLIGATION TO ADVISE — TRUST NO ONE?

It would appear that Big Pharma has metastasized to every organ of the health-care system.  Whoever a cancer patient turns to for help may well be a Pharma salesman in disguise.

If awareness of this conclusion, and of the information reported above which supports it, might influence a patient's willingness to undergo a therapy, then I think we are agreed that it is the obligation of the therapist to bring this information to his patients' attention.  And, of course, the researcher has the same obligation to his clinical-trial subjects.

Are you then ready, Dr Richardson, to begin warning your patients and your subjects that everybody they deal with in connection with their cancer may be involved in money-transfers related to the treatment being recommended?  Everybody including yourself?  Everybody especially yourself, it should be said, in view of your three-year-five-month $19.6 million OpenPayments involvement.

If you are not ready to make this disclosure to your patients and your subjects, then perhaps you are under an obligation to explain why?


BACKLOG BUILDING UP

In closing, I bring to your attention that the questions that you have been asked, but have not yet begun to answer, are piling up:

Most Recent
Index finger points down at most recent article
  31Jan2018  DR PAUL RICHARDSON: WHO CAN A CANCER PATIENT TRUST?
  25Jan2018  DR PAUL RICHARDSON: DOES THE DISCLOSURE OF EIGHTEEN NUMBERS CLARIFY KAPLAN-MEIER?
  11Jan2018  DR PAUL RICHARDSON: DOES PSEUDO-DISCLOSURE LEAD TO MISINFORMED CONSENT?
  05Jan2018  DR PAUL RICHARDSON: HOW MANY SUBJECTS PER GROUP?
  31Dec2017  DR PAUL RICHARDSON: DOES A CANCER PATIENT HAVE TO WORRY ABOUT HOSPITAL CORRUPTION AS WELL?
  21Dec2017  DR PAUL RICHARDSON: WILL YOU WEAR A PHARMA-POWER-DISCLOSURE BADGE?
  17Dec2017  DR PAUL RICHARDSON: PLEASE JUSTIFY KAPLAN-MEIER



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