$2.2 ☆ THE JOHNSON & JOHNSON RAP SHEET — WHO NEEDS TO SEE IT?
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      


THE JOHNSON & JOHNSON RAP SHEET —
WHO NEEDS TO SEE IT?
by Semmel Weis

First published 21Nov2017    Last edited 26Nov2017  01:05am


WHAT IS A DRUG MERCHANT REQUIRED TO DISCLOSE?

The International Council for Harmonisation-Good Clinical Practice (ICH-GCP) requires that candidates for participation in a clinical trial be informed of anything that might change their willingness to participate:

International Council For Harmonization-Good Clinical Practice logo
ICH.ORG

1.28  Informed Consent

A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate.  [...]

4.8.2  The written informed consent form and any other written information to be provided to subjects should be revised whenever important new information becomes available that may be relevant to the subject’s consent.  [...]  The subject or the subject’s legally acceptable representative should be informed in a timely manner if new information becomes available that may be relevant to the subject’s willingness to continue participation in the trial.  [...]

4.8.7  Before informed consent may be obtained, the investigator, or a person designated by the investigator, should provide the subject or the subject's legally acceptable representative ample time and opportunity to inquire about details of the trial and to decide whether or not to participate in the trial.  All questions about the trial should be answered to the satisfaction of the subject or the subject's legally acceptable representative.  [...]

4.8.10  Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include explanations of the following:  [...]

(p) That the subject or the subject's legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the subject's willingness to continue participation in the trial.

One of the things that might change willingness to participate is information concerning the integrity of the researchers.  Take for example the case of Johnson & Johnson's Risperdal.

ONE OF JOHNSON & JOHNSON'S DRUGS: RISPERDAL

FDA LOGO
November 4, 2013: Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations
FDA BADGE OFFICE OF CRIMINAL INVESTIGATIONS  

Food and Drug Administration
Office of Criminal Investigations


U.S. Department of Justice Press Release

United States Attorney
Office of Public Affairs

FDA

Allegations Include Off-label Marketing and Kickbacks to Doctors and Pharmacists

WASHINGTON — Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation's largest long-term care pharmacy provider.  The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.

"The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust," said Attorney General Eric Holder.  "This multibillion-dollar resolution demonstrates the Justice Department's firm commitment to preventing and combating all forms of health care fraud.  And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people."  [...]


Anyone considering participating in a Johnson & Johnson clinical trial might reasonably decide that the disregard Johnson & Johnson showed for subject safety in selling Risperdal is good enough reason to avoid participating in any Johnson & Johnson clinical trial staged thereafter.  And because this $2.2 billion FDA penalty is capable of influencing a candidate's willingness to participate, it is obligatory to bring to every candidate's attention the information expressed briefly in the RED BOX below, and accompanied by documentation such as the FDA report cited above:

FIRST VERSION
This unofficial RED BOX WARNING is not yet an official
FDA logo
BLACK BOX WARNING, but should be:

Anyone weighing the decision of whether or not to undergo any Johnson & Johnson medical treatment, whether within therapy or within a clinical trial, should bear in mind that in 2013 Johnson & Johnson was penalized US$2.2 billion for health care fraud which jeopordized the health and safety of patients, and which is one of the largest health care frauds in US history, as is most vividly exemplified in its marketing of Risperdal.


However, perhaps it can be argued that although presenting the information above is a step in the right direction, the information is incomplete.  For one thing, we are told that the Johnson & Johnson conduct "jeopardized" health and safety, but was anyone actually hurt, by the Risperdal (of the three drugs complained of by the FDA), and what was the nature of the injury?


ONE OF RISPERDAL'S SIDE EFFECTS: GYNECOMASTIA

Like every pharmaceutical, Risperdal has many side effects.  Among the most common is weight gain and obesity, which everybody can be expected to understand and visualize.  A slightly less common, but certainly more startling, side effect of Risperdal is "gynecomastia", a word almost nobody understands, and which if merely explained using words is capable of leaving only a vague and inaccurate impression.  It is only photographs that are able to leave an impression that is accurate and memorable, and that impression is that the two together — weight gain plus gynecomastia — are devastating:
FELDMAN/PINTO POSTER SHOWING RISPERDAL BOX AND TWO GYNECOMASTIA VICTIMS

The autism drug Risperdal can cause Gynecomastia: “female” breasts in boys and young men.  In some cases, the breasts grow to size 46DD.  (You may hear people refer to these breasts as “man boobs” or “moobs.”)  The medical malpractice lawyers at Feldman & Pinto sue doctors who fail to watch for this serious Risperdal side effect in their autistic patients.    feldmanpinto.com



DrugWatch logo PetaPixel logo PetaPixel logo
RISPERDAL OBESITY-GYNECOMASTIA VICTIM RISPERDAL OBESITY-GYNECOMASTIA Tampa portrait
RISPERDAL OBESITY GYNECOMASTIA Tampa portrait

"The degree of enlargement can vary from one individual to another, and while gynecomastia most often occurs in both breasts, it can affect just one.  When the condition strikes both breasts, each can be affected differently.  One breast can grow larger than the other, leaving the drug users with an even more uncomfortable social stigma.  In some cases of gynecomastia, males produce breast milk."    drugwatch.com

"[Photographer Richard] Johnson says that despite being slapped with a $1.2 billion fine in 2012 and a $2.2 billion fine in 2013, and despite the thousands of ongoing lawsuits, Johnson & Johnson still sold $800 million worth of Risperdal in 2016."   petapixel.com



CONSUMER NEWS WEEKLY LOGO
Before and after Risperdal-Gynecomastia surgery
Before and after corrective surgery.

"Federal officials said that JPI [Janssen Pharmaceuticals Incorporated, owned by Johnson & Johnson] also marketed Risperdal for use in children with behavior challenges, despite known health risks to children and adolescents."     ConsumerNewsWeekly.com

And so if it is the case that the information concerning two of the side effects of Risperdal, weight gain and gynecomastia, might influence a clinical-trial candidate's willingness to participate in any future Johnson & Johnson clinical trial, then Johnson & Johnson has an obligation to disclose that information.  And if adding photos influences willingness more, then it becomes obligatory to add the photos as well.

SECOND VERSION
This unofficial RED BOX WARNING is not yet an official
FDA logo
BLACK BOX WARNING, but should be:

Anyone weighing the decision of whether or not to undergo any Johnson & Johnson medical treatment, whether within therapy or within a clinical trial, should bear in mind that in 2013 Johnson & Johnson was penalized US$2.2 billion for health care fraud which jeopordized the health and safety of patients, and which is one of the largest health care frauds in US history, as is most vividly exemplified in its marketing of Risperdal, among whose side effects is weight gain and gynecomastia:

RISPERDAL OBESITY-GYNECOMASTIA VICTIM

And yet the information needed for the clinical-trial candidate to be considered informed enough to give informed consent is still incomplete.

RISPERDAL HAS SIDE EFFECTS IN ADDITION TO GYNECOMASTIA

As if weight gain together with gynecomastia wasn't suffering enough, see on the left below how many other afflictions Risperdal brings, and upon how many people.  The already-mentioned weight increase is represented at ordinal positions 2 and 5, in 2810+2211=5021 cases, though it's unclear whether the two numbers can be added, as their categories might overlap.  Diabetes appears in positions 3 and 7, in 2568+1782=4350 cases, same caution.  And can it be said that the picture of Johnson & Johnson irresponsibility is complete without pointing out also that Death=1216, Suicide Attempt=1118, Psychotic Disorder=1112, Fall=1072.

In sum, the possibility exists that a Risperdal user who develops obesity-gynecomastia might at the same time be plagued with a dozen other adverse reactions.  And the possibility exists as well that a Risperdal user who manages to avoid pronounced obesity-gynecomastia might nevertheless be devastated by a dozen of the other afflictions which Risperdal brings.

And what, by the way, do nine out of every ten of us, and probably more than that, learn when we read Hyperprolactinaemia=2474 or Galactorrhoea=1984?  We learn nothing, the vast majority of us, because we have no idea what the words mean.  According to Wikipedia, "Hyperprolactinaemia may cause galactorrhea (production and spontaneous flow of breast milk) and disruptions in the normal menstrual period in women and hypogonadism, infertility and erectile dysfunction in men".  A photo of galactorrhea (in this case unaccompanied by obvious gynecomastia) in a 17-year-old male: 
everydayebm.org

And the table on the right below — what can we conclude from it?  Given that psychiatric conditions are so loosely defined that any person can be stigmatized as harboring a large number of them, and given also that once government regulators have approved a drug for the treatment of specified conditions, every physician acquires the legal power to prescribe that drug for any conditions he chooses — then it becomes inevitable that that drug will come to be prescribed for just about every ailment imaginable, such unapproved-but-legal treatment bearing the name "off-label".

RISPERDAL ADVERSE REACTIONS AND REASONS FOR TAKING FROM AskAPatient AskPatient.com

Of course this further information concerning other adverse effects is capable of further influencing the candidate's willingness to participate, which obligates the trial sponsor to provide that further information to every candidate, somewhat like this:

TO BE ADDED TO THE RED BOX WARNING

Among other adverse reactions to Risperdal can be found diabetes, depression, anxiety, death, suicide, aggression, and psychotic disorder.



JOHNSON & JOHNSON INCREASES SALES BY GOING OFF-LABEL

Two references to J&J having wandered off label have already been encountered above.  First, the FDA decision faulted J&J for "promotion for uses not approved as safe and effective".  Second, ConsumerNewsWeekly said that Johnson & Johnson "also marketed Risperdal for use in children with behavior challenges, despite known health risks to children and adolescents".

A probability, perhaps even a certainty, that a candidate for any Johnson & Johnson treatment must keep in mind is that even if a drug were safe and effective, it would not be so for everybody, as perhaps not for the particularly young or the particularly old.  This is a concern regarding which Johnson & Johnson has shown itself to be particularly neglectful because its easiest way of making more money is to extend drug use to the vast number of people for whom the drug has not been approved.  In the case of the Risperdal misconduct addressed by the FDA in 2013, J&J selling Risperdal to unapproved age groups can be summarized as follows:

RISPERDAL MARKET IN 2000 RISPERDAL FORBIDDEN SALES IN 2000
Steven Brill, America's Most Admired Lawbreaker, Chapter 3, Huffington Post, 2015

And which therefore calls for something like the following elaboration:

TO BE ADDED TO THE RED BOX WARNING

Clinical-trial candidates might also keep in mind that as Johnson & Johnson has a history of pushing its drugs at people for whom use has not been approved, or even at people for whom use has been contraindicated, it becomes appropriate to wonder whether Johnson & Johnson would be acting just as recklessly in accepting you as a subject in the clinical trial for which it happens to be currently soliciting participation.



J&J DOES NOT SHUN THE MARKETING TOOL OF DATA FALSIFICATION

The following box quote describes destruction of files which Big Pharma did not want the FDA to see, possibly because those files would reveal that certain drugs are more dangerous and less effective than was being broadcast, or possibly also because they would reveal that tampering and fabrication have taken place, or possibly also because the data, in small or large part, had never been gathered and did not exist.  The Dr Scheiner examples refer to a destruction of Johnson & Johnson files, and the Dr Savery example describes destruction of Hoffman-La Roche files (bold emphasis in the excerpt below has been added).

CORPORATE CRIME IN THE PHARMACEUTICAL INDUSTRY CORPORATE CRIME IN THE PHARMACEUTICAL INDUSTRY
by John Braithwaite   1984

Some physicians have been the subject of terrible misfortunes on the eve of FDA investigations into the quality of the data they have collected for submission to the agency in support of new drug applications.  Dr James Scheiner, an orthopedic surgeon of Fairfax, Virginia, who had done several experiments for Johnson and Johnson, had his office vandalized the night before an FDA audit of his raw data.  The mindless vandals dumped all the records relating to the studies to be audited into a whirlpool bath.  Just before his next scheduled FDA audit Dr Scheiner had a fire in his office.  And the night before that inspection was rescheduled, Dr Scheiner was viciously mugged by an assailant who wielded a paperweight from his office.  Another doctor, Francois Savery, who had earned a fortune testing experimental drugs for Hoffman-La Roche and other leading companies, suffered the misfortune of accidentally dropping his data overboard while out in a row boat.  — John Braithwaite
Internet Archive logo  

This book is in the public domain and can be read or downloaded in several formats at  Internet Archive

The above evidence-destruction took place more than thirty years ago, but as data falsification is endemic at Johnson & Johnson, instances can be found at all times, as for example the manner in which J&J lowered the gynecomastia rate among boys on Risperdal from 4.5% to 0.8%, as explained in Steven Brill's display below.  The upper half of the display shows the proper computation of the 4.5% estimate.  Keep the following in mind as you regard the four boys in the denominator — the drawn-blue boys never developed gynecomastia, and the drawn-red boys evenutally did; the drawn-short boys are younger than 10, and the drawn-tall boys are at least 10.  In the denominator, then, are all the boys — older and younger, those who eventually developed gynecomastia and those who did not.  In the numerator are placed only the boys who got gynecomastia, some being older (17 of them) and some younger (5 of them), which is as it should be, given that we are calculating the proportion of boys who developed gynecomastia.

But as J&J found 4.5% unacceptably high, it proceeded to take both of the steps which are able to lower the value of a fraction — deflate the numerator, inflate the denominator.  Now look at the bottom half of Steven Brill's display to witness J&J performing this numerator deflation and denominator inflation, whose result was to replace the insufferable 4.5% with the more tolerable 0.8%.

To make the numerator smaller, J&J simply removed the 17 "Boys 10 and over with gynecomastia" from the numerator.  But as what was being computed was the gynecomastia rate for boys, there was no justification for removing the 17 gynecomastia boys from the numerator — once they have been admitted into the denominator, then they absolutely must be also allowed entry into the numerator.

And to make the denominator bigger, J&J simply added 103 "Girls (all ages) without gynecomastia" into the denominator.  But as what was being computed was the gynecomastia rate for boys, then there was no justification for admitting even a single girl into any part of the fraction, let alone 103 girls into the denominator.

J&J's ‘Re-Analysis’ of the Data
JOHNSON & JOHNSON FRACTION MAGIC
Steven Brill, America's Most Admired Lawbreaker, Chapter 5, Huffington Post, 2015

Steven Brill condemns the above trickery in blunt language:

You only need to have gotten past a third-grade math lesson to understand how scientists from the world’s leading health care company and its hired-hand doctors distorted complicated clinical findings.
Steven Brill, America's Most Admired Lawbreaker, Chapter 5, Huffington Post, 2015

But the defeat of the above J&J attempt to lower the at-that-time-accepted gynecomastia rate among boys from 4.5% to 0.8% cannot be taken to mean that the true rate of 4.5% now stands rescued from corruption.  Rather, if the above instances of two kinds of Johnson & Johnson data falsification form only the tip of an iceberg, then all data coming from J&J deserves to be regarded with suspicion, as for example by expecting that an estimate of the gynecomastia rate computed by a competent and impartial researcher might be considerably higher than 4.5%.

Beyond that, there’s the larger question of whether the honor system works to ensure that companies with Johnson & Johnson’s Risperdal record, run by the same people who created that record, tell the FDA everything, good and bad, about all of their clinical studies.  Every day we read another headline about [...] drug companies boasting potential new blockbusters whose tests so far look great.  Can we know that for sure?
Steven Brill, America's Most Admired Lawbreaker, Chapter 15, Huffington Post, 2015


TO BE ADDED TO THE RED BOX WARNING

As Johnson & Johnson is known to practice data falsification, J&J-sponsored-clinical-trial candidates need to greet all Johnson & Johnson claims and conclusions with a degree of skepticism.



JOHNSON & JOHNSON WAS NOT PUNISHED: IT WAS SLAPPED ON THE WRIST

For Johnson & Johnson, the $2.2 billion 2013 sanctions that were described by the FDA at the top of the instant page were an incidental expense on the road to riches.  In 2007 alone, and for Risperdal alone, J&J sales were $4.5 billion, and over its first two decades, and in the US alone, Risperdal brought in $18 billion in profits:
LOGO DrugWatch


Risperdal slap on the wrist

A Huge Moneymaker for J&J

Johnson & Johnson's Janssen Pharmaceuticals unit manufactures Risperdal.  The drug was a huge moneymaker for the company, with annual sales peaking at more than $4.5 billion in 2007.  Profits declined once J&J lost patent protection, and the company reported only $358 million in name-brand sales in 2012.

Still, it’s estimated that the company made $18 billion in profits on Risperdal during the roughly first two decades it was available in the U.S.  To get there, J&J allegedly engaged in illegal marketing practices, including marketing Risperdal to children, paying doctors to speak favorably of the drug and paying kickbacks to the country’s largest pharmacy for nursing homes for promoting Risperdal to doctors treating nursing home patients.      DrugWatch

And Johnson & Johnson personnel seem to have avoided punishment:
Johnson & Johnson has never come forward with any information that any of its employees was disciplined or fired for illegally promoting Risperdal.

Steven Brill, America's Most Admired Lawbreaker, Chapter 15, Huffington Post, 2015

And investors did not dump JNJ stock:
On the trading day before the settlement was announced, Johnson & Johnson stock closed at $93.37.  A week after the announcement, it closed at $94.29.  A year later, as thousands of Risperdal personal injury suits were pending, it would close at $108.62.

Steven Brill, America's Most Admired Lawbreaker, Chapter 11, Huffington Post, 2015

All in all, the punishment was small, the chastisement tolerable, and therefore Johnson & Johnson cannot be expected to have learned its lesson and to have mended its ways.
Moving Up

At Johnson & Johnson, everyone seems to have moved on.  And up.  [...]

All in all, in terms of the company’s fortunes and the career trajectories of the people responsible for its conduct, it is hard to argue that the system produced much of a deterrent when it comes to illegally promoting its powerful products.  It is equally hard not to wonder, considering the totality of the Johnson & Johnson Risperdal story, how much we can count on the integrity of a dominant industry whose most admired company admitted so little, promoted so many of those responsible and continues to thrive so mightily.

Steven Brill, America's Most Admired Lawbreaker, Chapter 15, Huffington Post, 2015


TO BE ADDED TO THE RED BOX WARNING

Seemingly-crushing penalties cannot be expected to have taught J&J its lesson and to have led it to mend its ways because these penalties have in fact been trivial when compared to the immense profits that have continued to flow into J&J coffers.  Thus it is that information concerning J&J misconduct of years ago continues to be relevant today because the deterrent to stop that misconduct has in fact been weak.



TWO THINGS ABOUT JOHNSON & JOHNSON CEO ALEX GORSKY

One thing about Alex Gorsky is that he seems remarkably cheery given that he, more than anybody else on earth, is responsible for the Risperdal catastrophe:

Alex Gorsky at Johnson & Johnson wall

Beginning in 1997, the sales manager of the J&J division responsible for Risperdal sales in the U.S. was Alex Gorsky, a West Point graduate and former army captain.

Steven Brill, America's Most Admired Lawbreaker, Chapter 2, Huffington Post, 2015


The documents also demonstrate that as head of Risperdal sales and then head of the Johnson & Johnson subsidiary that marketed Risperdal, Alex Gorsky, the current Johnson & Johnson chairman and chief executive, had a sustained, hands-on role in what the company has since admitted in a plea bargain (that nonetheless named no individuals) was illegal activity.  That raises significant questions about whether our legal system can, and will, ever hold the high-ranking people who run our largest corporations, rather than inert corporate entities, responsible for wrongdoing.

The Houdini act that enabled Gorsky, the then-Risperdal sales manager, not only to escape responsibility but also to be promoted to the top of his industry’s most admired company raises equally significant questions about the standards of conduct we can expect from those who run what is becoming the world’s most powerful industry, and about how much we can rely on the medicines they sell.

Steven Brill, America's Most Admired Lawbreaker, Chapter 1, Huffington Post, 2015


This was the first time any government document had tied Alex Gorsky to the Risperdal scandal.  It did so in unrelenting detail, with each point followed by a reference to a document that the government had obtained through subpoenas to Johnson & Johnson and Janssen:

  • "From October 1998 to October 2001, Mr. Gorsky was Janssen’s Vice President of Marketing, and from October 2001 to early 2003 he was President of Janssen."

  • "During all of that time he was responsible for selling Risperdal, a drug whose biggest customer was Omnicare."
Steven Brill, America's Most Admired Lawbreaker, Chapter 10, Huffington Post, 2015

The other thing about Alex Gorsky is how well he pays himself, given that he is responsible for the Risperdal catastrophe (and other catastrophes like it, as we will have opportunity to glimpse farther below).

And just how well does Alex Gorsky pay himself?  Salary.com estimates that in 2016, it was $21.2 million:



salary.com

Relevance to the theme of this essay, which is what it is obligatory to tell people who are considering clinical-trial participation?  It is obligatory to tell J&J clinical-trial candidates about Alex Gorsky's 2016 income of $21.2 million because that information might influence their willingness to participate.  How so?

Consider first a patient discussing with a doctor whether to take DRUG-A or DRUG-B or pursue a NO-DRUG-THERAPY or to LEAVE-UNTREATED.  The patient has the right to expect that the doctor's recommendations will be based entirely on estimated impact on health and longevity, and based not at all on consequences to anybody's wallet — and possibly most patients naively take this reasonable expectation to be an existing reality.  And so if the doctor were in truth going to pocket $100 of the daily $500 per pill which constitutes DRUG-A treatment, then the patient would have a right to know this, and the doctor would have an obligation to disclose it.

So then what might this patient think upon learning that this pill is sold by a CEO who rakes in $21.2 million a year?  The patient might suddenly realize that a chunk of that daily $500 is going to make its way into the pocket of that CEO, and that therefore that CEO has a powerful motive to urge consumption of that pill, and even to bend the truth a little here and there to convince people to take the pill, and might realize also that other chunks of that daily $500 are similarly destined to find paths into the pockets of other people thereby distracting them too from what should be their sole motive of patient welfare.

The disclosure, then, of a CEO's annual $21.2 million remuneration is capable of transforming perception from a scene of a patient surrounded by selfless professionals dedicated exclusively to patient health and survival to perception of an opposite scene of a cigar-chomping nabob, rumored to be raking in $21.2 million a year, who holds out a pill between thumb and forefinger, all the while swearing on his mother's grave that it's good for what ails you, and demands $500 for it.

The rule that is embedded in the ICH-GCP excerpts at the top of the instant page is that if information might affect willingness to undergo a therapy or to participate in a clinical trial, then it is obligatory to provide that information, both to a patient comparing alternative treatments, and to a clinical-trial candidate contemplating participation.  Alex Gorsky's annual $21.2 million might affect willingness to participate, therefore Alex Gorsky's annual $21.2 million must be disclosed to everybody considering participation in any Johnson & Johnson clinical trial.

TO BE ADDED TO THE RED BOX WARNING

The greater the cash flow from your pocket into the pockets of people you have to deal with, the more you have to consider the possibility that your relationship is largely economic, and may become so overwhelmingly economic as to altogether cast off being therapeutic.  Begin your economic analysis with the fact that Johnson & Johnson CEO-and-Chairman Alex Gorsky's remuneration in 2016 was $21.2 million, then place beside that the daily cost of the relevant J&J prescription, which in some cases will run to $500 per pill, and carry your analysis forward from there.



JOHNSON & JOHNSON IS BEING COMPLAINED OF FOR MORE THAN RISPERDAL

The relevant information needed for informed consent is incomplete so long as the clinical-trial candidate is able to imagine Risperdal as J&J's isolated mistake, and that whatever irresponsibility attaches to it is unlikely to accompany other J&J products.

However, the poster below suggests that Johnson & Johnson continues to this day to lead the pharmaceutical world in irresponsibility no matter what product it ventures to sell.

The verdicts in the six 2016 cases below, then, are for injuries suffered by six individuals.  Only one award is for Risperdal injury, which is the $70 million awarded Andrew Yount who was put on Risperdal at the age of five, and where the jury found that J&J's Janssen unit intentionally falsified, destroyed or concealed evidence.  Of the remaining five 2016 awards, two are for the J&J Pinnacle Hip Implant, and three are for J&J Talcum Powder.

The bottom of the same poster ventures beyond 2016 to two outstanding 2017 awards, adding another instance of a Talcum Powder award ($110 million), and adding a new cause of injury, the Johnson & Johnson Ethicon Pelvic Mesh ($20 million).

ALT=LOSSES

The poster below compares total penalties amassed during 2016 by the eight most-erring companies, with J&J heading the pack with $6.3 billion (gets to sit on the largest planet, Jupiter) and Takeda in second place with $6.0 billion (gets to sit on the second-largest planet, Saturn), these two companies being of particular interest to myeloma patients because of their shared responsibility for Bortezomib (Velcade):

Takeda Oncology, (originally Millennium Pharmaceuticals), is a biopharmaceutical company based in Cambridge, Massachusetts. It is a fully owned subsidary of Takeda Pharmaceutical.  [...]  It is particularly known for bringing bortezomib (marketed as Velcade) through clinical trials to approval for treatment of patients with multiple myeloma by the U.S. FDA, but has a growing clinical development pipeline of other product candidates.  [...]  Ortho Biotech and Janssen-Cilag, members of the Johnson & Johnson Family of Companies, are responsible for commercialization of VELCADE in Europe and the rest of the world.     Wikipedia

Pharma Criminal & Civil Settlement Planetary System 2016
pharma-mkting.com

TO BE ADDED TO THE RED BOX WARNING

Anyone contemplating use of any Johnson & Johnson health product, whether in therapy or during a clinical trial, should be aware that Johnson & Johnson is a world leader in manufacturing dangerous products whose use leads to record-setting awards for egregious injuries, as is reflected in two statistics covering the US in 2016: (1) 6 of the 7 largest verdicts faulted J&J products, and (2) J&J's criminal and civil settlements totalling $6.3 billion exceeded those of any other pharmaceutical company.



JOHNSON & JOHNSON'S CHEMICAL STRAITJACKET FOR CHILDREN

Johnson & Johnson's highest priority has been to deliver Risperdal to children whose teachers wish would shut up and stop fidgeting.  Better that children be drowsy rather than restless, is the attitude of teachers who thank Risperdal for its most valued effect — somnolence.

However, somnolence is incompatible with scholarship, as are other Risperdal side effects — like depression, anxiety, insomnia, suicide attempt, aggression, psychotic disorer — so that doping children with Risperdal puts obstacles in the way of their scholastic achievement.  In other words, let Johnson & Johnson at our kids, and we can expect an epidemic of failing grades.

Added to that may be that Risperdal side effects extend beyond the time that Risperdal is administered, sometimes years beyond, sometimes decades beyond, sometimes a lifetime beyond, and possible too that Risperdal shortens that lifetime.

These are very perilous risks that Johnson & Johnson feels it has a right to expose children to, given that the only offsetting benefit is fattened Johnson & Johnson wallets.

RISPERDAL LEGO BRICKS AIMING TO TURN CHILDREN INTO J&J ZOMBIES
Steven Brill, America's Most Admired Lawbreaker, Chapter 3, Huffington Post, 2015

"CONDUCT DISORDERS" IN CHILDREN

That was their posture on March 3, 2000, when about a dozen product development scientists and regulatory executives from Johnson & Johnson met to talk about Risperdal and children.  Once again, the J&J team’s goal was to get the label extended to include "conduct disorders" in children.  This would not only sanction the marketing that the company was already doing; it would also extend the overall Risperdal patent for six months under a law that gives pediatric drugs longer protection from generics.

According to minutes of the meeting recorded by someone on the J&J side of the table, the FDA officials wasted no time shooting down the premise of the proposal: "The FDA questioned the validity of conduct disorder (CD) as a diagnosis and even the concept of CD as a disorder," the minutes reported, "because it is just a list of behaviors, mainly aggressive behaviors that annoy others. … Their main concern is that Risperdal or any other product would be used as a chemical straitjacket."  [...]

By the fall of 2000, 21 percent of Risperdal being sold was going off-label to children and adolescents, and the sales teams had been told that expanding that market was the company’s highest priority.

Houston sales manager Tone Jones would later testify that "the message from headquarters" was that "hostility, aggression, agitation" was a "significant opportunity" for the company to achieve what was by then a target of nearly $3 billion in annual U.S. sales before the patent expired.

Steven Brill, America's Most Admired Lawbreaker, Chapter 3, Huffington Post, 2015    [bold emphasis added]

GETTING DRUGS FOR ACTING UP

The markets for kids and the elderly were called out as special priorities, Starr says, "because that’s where they saw all the growth.  With adults, you pretty much have to focus on the actual diseases — like schizophrenia — because adults don’t end up at the doctor getting drugs for acting up.  But kids, or the elderly with dementia, do."

Steven Brill, America's Most Admired Lawbreaker, Chapter 4, Huffington Post, 2015

JUST ABOUT ANY MENTAL HEALTH CONDITION

By the fall of 2003, Risperdal sales rep Vicki Starr was ready to quit.  She had been working for Janssen in the Northwest region for a little over two years.  During that time, her green manual full of sales material that at least devoted some attention to how the drug treated schizophrenia had been replaced, she says, by a "red binder full of material that directed the sales staff to sell to a full spectrum of symptoms that could be related to just about any mental health condition."

Steven Brill, America's Most Admired Lawbreaker, Chapter 6, Huffington Post, 2015

QUICKLY CONTROL CLASSROOM BEHAVIOR PROBLEMS

Back to School with Risperdal

Meanwhile, Johnson & Johnson was embarking on a 2003 "back to school" campaign (a district manager’s sales report actually called it that) to launch its M-tab version of the pill.  M-tabs would dissolve in a child’s mouth and, presumably, quickly control classroom behavior problems.  In San Antonio, a manager told his salespeople to hold ice cream parties in pediatricians’ offices to celebrate the launch.  Another manager told a rep to be sure to include "lollipops and small toys" in the sample packages she gave to the doctors she called on.

Steven Brill, America's Most Admired Lawbreaker, Chapter 6, Huffington Post, 2015

BEHAVIOR DISORDERS WERE MAYBE 3, 4 OR 5 PERCENT

Melsheimer asked the doctor what he meant.  "He walked me through," Melsheimer says, "how the market for which Risperdal had been approved — psychotic disorders like schizophrenia — affected maybe 1 percent of the population.  But behavior disorders were maybe 3, 4 or 5 percent."

Steven Brill, America's Most Admired Lawbreaker, Chapter 9, Huffington Post, 2015

PUSH ITS DRUG ON CHILDREN

"This is an interesting phrase," he began, reading from what he explained was the company’s 1994 marketing plan.  "The anticipated growth of the antipsychotic market does not create enough room for the Risperdal sales forecast. … In other words, there’s not enough schizophrenic people to sell Risperdal to get our sales forecast hit. … That meant that they were going to have to establish it as a broad-use product.  Again, this is in the fall of 1994.  And what does that mean?  A critical success factor for them in that market expansion — they identified this back in 1994 — was children.  Children.  Now, think about this.  The success they’re talking about here was not a medical breakthrough.  It was a financial breakthrough.  Janssen knew that if it could sell-push its drug on children, it could help make the drug financially successful."

Steven Brill, America's Most Admired Lawbreaker, Chapter 3, Huffington Post, 2015

DOCTORS WHO SPECIALIZED IN TREATING CHILDREN

The FDA could have pulled the same data Johnson & Johnson regularly bought, and seen that Risperdal prescriptions were being written disproportionately by doctors who specialized in treating children and the elderly.  But if someone there did, no one acted on it until the whistleblowers came forward.

Steven Brill, America's Most Admired Lawbreaker, Chapter 15, Huffington Post, 2015

Drug pusher says IT'S OK, I'M A DOCTOR

TO BE ADDED TO THE RED BOX WARNING

Ask yourself whether it is prudent to submit to any Johnson & Johnson treatment given the danger that you have seen J&J exposing children to in its heedless pursuit of profit.



IT'S UNINFORMED CONSENT THAT RAKES IN THE DOLLARS

The RED BOX WARNING below concerns itself with Johnson & Johnson misconduct, and which has already been described by others.  This RED BOX WARNING needs to be added to the many previous RED BOX WARNINGS that are under discussion on the pages of semmel-weis.org which focus on methodological gaffes which invalidate Johnson & Johnson research.

Of course it is inconceivable that this, or any other, RED BOX WARNING will ever be brought to the attention of those receiving any Johnson & Johnson treatment, whether as patients or as clinical-trial subjects — which is to say that it is inconceivable that J&J patients or subjects will ever be informed enough to be able to give their informed consent.

FINAL VERSION
This unofficial RED BOX WARNING is not yet an official
FDA logo
BLACK BOX WARNING, but should be:

Anyone weighing the decision of whether or not to undergo any Johnson & Johnson medical treatment, whether within therapy or within a clinical trial, should bear in mind that in 2013 Johnson & Johnson was penalized US$2.2 billion for health care fraud which jeopordized the health and safety of patients, and which is one of the largest health care frauds in US history, as is most vividly exemplified in its marketing of Risperdal, among whose side effects is weight gain and gynecomastia:

RISPERDAL OBESITY-GYNECOMASTIA VICTIM

Among other adverse reactions to Risperdal can be found diabetes, depression, anxiety, death, suicide, aggression, and psychotic disorder.

Clinical-trial candidates might also keep in mind that as Johnson & Johnson has a history of pushing its drugs at people for whom use has not been approved, or even at people for whom use has been contraindicated, it becomes appropriate to wonder whether Johnson & Johnson would be acting just as recklessly in accepting you as a subject in the clinical trial for which it happens to be currently soliciting participation.

As Johnson & Johnson is known to practice data falsification, J&J-sponsored-clinical-trial candidates need to greet all Johnson & Johnson claims and conclusions with a degree of skepticism.

Seemingly-crushing penalties cannot be expected to have taught J&J its lesson and to have led it to mend its ways because these penalties have in fact been trivial when compared to the immense profits that have continued to flow into J&J coffers.  Thus it is that information concerning J&J misconduct of years ago continues to be relevant today because the deterrent to stop that misconduct has in fact been weak.

The greater the cash flow from your pocket into the pockets of people you have to deal with, the more you have to consider the possibility that your relationship is largely economic, and may become so overwhelmingly economic as to altogether cast off being therapeutic.  Begin your economic analysis with the fact that Johnson & Johnson CEO-and-Chairman Alex Gorsky's remuneration in 2016 was $21.2 million, then place beside that the daily cost of the relevant J&J prescription, which in some cases will run to $500 per pill, and carry your analysis forward from there.

Anyone contemplating use of any Johnson & Johnson health product, whether in therapy or during a clinical trial, should be aware that Johnson & Johnson is a world leader in manufacturing dangerous products whose use leads to record-setting awards for egregious injuries, as is reflected in two statistics covering the US in 2016: (1) 6 of the 7 largest verdicts faulted J&J products, and (2) J&J's criminal and civil settlements totalling $6.3 billion exceeded those of any other pharmaceutical company.

Ask yourself whether it is prudent to submit to any Johnson & Johnson treatment given the danger that you have seen J&J exposing children to in its heedless pursuit of profit.

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