Dana-Farber Cancer Board Member discusses Dr. Burzynski, Antineoplastons, & Industry

Dana-Farber Cancer Institute Board of Directors Member James Rappaport discusses Dr. Burzynski and The Cancer Industry
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“When you look at what is going on and how Dr. Burzynski’s being handled, it is clearly a function of, (?), anytime you have big business, big government, big labor, Big Pharma, Big Cancer Industry, whatever, they become so, wrapped up in protecting the institution; whatever it is, that they forget what their fundamental job is, you know, and what’s happened with Big Pharma and, and Big Cancer, is they kinda, you know, they’ve forgotten to be curious that there might be other op, opportunities and options out there, and they’re focused on protecting their turf”
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00:41 – Peer-review chauvinism
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“Most of the stuff is peer-reviewed, in order to get into, the starting gate, of their process”

“Well, if you’re all of the peers, are vested in one piece of the business, something new, is frightening, and is not going to be given the same shot, as something that’s within the construct of what they’re used to”

“That’s the problem, uh, and the idea that something different; less catastrophic to the body, um, could possibly, uh, work, would upset all of their training, all of their thinking, and, it, it’s very hard for them to, to to do that”
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01:24 – The anointed Evangelical Guardians of the Status Quo
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“The doctors I know and, and the clinicians I know, and, and these people are evangelical”

“I mean, they are hugely, vested and invested, in doing what they believe is very important and good work”

“It helps them get up in the morning, to go to work”

“So, folks who are, invested that kind of, uh, you know, zealous way, you know, are going to look at anything that isn’t within that, that, that, that vision, you know, they’re going to look askance at it”

“They’re going to look at, say that, that, that’s really weird, or, that’s a charlatan”

“What they were in essence saying is, that if you do, the Burzynski treatment regimen, you are foregoing the treatments that we know and understand, and thus we can’t, guarantee that you’re going to have a success”

“Well, you can’t guarantee that you’re going to have a success with chemotherapy, or the normal regimens of chemotherapy

“So, they came from a place of saying: ‘We are protecting you from going down and taking a, uh, the placebo approach,’ which is the way they look at it”

“The fact that it’s been effective, and the fact that, uh, you know, when you go through the numbers, uh, and the analysis, and you go through, uh, that if you’ve not gone through chemotherapy, and you go through the Burzynski’s treatment your odds are 2 or 3 times as high, even if you have gone through chemotherapy it’s 1 or 2 times as high”

“You know, those are, un, those are high enough numbers to push the needle, and, oh by the way, it’s less expensive, than Big Pharma
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02:56 – Protecting the business at all costs
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“Which is another big piece”

Big Pharma is protecting a huge, multi-billion dollar business, and they’re going to protect it to the death, even, to the adverse impact of patient outcomes”

“They won’t say it that way, and, but that fact of the matter is, if you’ve got an approach out here which could be significantly, less costly, and significantly less adversely impact-full, to the patient, um, then you’re gonna, um, you, you, you can understand why they’re, to doing”

“You don’t have to agree with it, but you can at least understand why they’re taking the position that they’re taking”
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03:34 – The fiber of an innovator’s background
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“I think that what is amazing is that Dr. Burzynski has had a vision, and a passion, and a zeal, for 40-odd years, put up with being called everything, short of, and probably even including ‘Witch Doctor,’ um, because of his firm belief that he can save people’s lives, and, and what that says about his character and his just his, the fiber of his backbone, to, um, to be willing to take that on”

“You know, you’re talking about a man who spent the last 40 years, um, you know, working on, on a different form of treatment that is more patient friendly, than chemotherapy

“You know, I explain to people about, you know, what chemotherapy is”

“What chemotherapy is, is putting poison in your body”

“Killing everything that is fast-growing in your body”

“Starting first with cancer cells”

“Then next with white-blood cells”

“Then with your hair”

“Then with your, you know, the inside lining of your mouth”

“Um, then your fingernails”

“I mean, you know, that, that’s what it’s meant to do, and what you essentially do is you give this chemotherapy to, as much as a person can take, uh, uh, uh, in order to, you know, in, in, in order to get out the other end where’ve you’ve killed cancer and hopeful not everybody else or the patient”

“That’s what it is”

“So, if you’ve got a different approach, which is, essentially is saying, well, you know, we’re not, we’re gonna go in and stop the cancer cells from growing and we’re going to actually, and, uh and work on shrinking them, without the ancillary effects, is pretty powerful, you know, and, uh, and you would think that, that, that, the Big Cancer Industry would say: ‘That’s something we outta be looking at'”

Burzynski needs to be given the right to prove the efficacy of his treatment, and if he can, uh, show that his treatments are as or more effective, and / or, significantly better for the patient, with better patient outcomes and, and limited side effects, he’s gotta be given that opportunity to compete out in the marketplace”

“That’s what America’s about”
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12/4/2013Jim Rappaport, Board Member of Dana-Farber Cancer Institute discusses Dr. Burzynski and the obstacles he faces within a Cancer Ind (5:49)
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http://www.dana-farber.org/uploadedFiles/Library/modules/IRS_990_Form/dana-farber-board-of-trustees.pdf
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http://www.rappaportfoundation.org/about/board.html
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http://www.specialtyhospitalsofamerica.com/jim-rappaport/
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http://www.petangelworldservices.com/board.php?bio=rappaport
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http://www.newbostonfund.com/Company-Overview/Executive-Team/James-Rappaport.asp
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Turkey Lurkey Thanksgiving Title

Traditionally, Thanksgiving is best known as the Holiday that the Detroit Lions get the “stuffing” knocked out of them

However, this year, it’s time to tender the tainted twisted trophy of Thanksgiving Turkey-Lurkey to Detroit’s toasted triumvirate treat of two-faced twerk-salad troll turpitude, and I have the temerity to tinker and tamper until I pay tribute with therapeutic levels of Thoreauness in response to GorskGeek’s misinformation, disinformation, and MisDisInformation (Missed ‘Dis Information)

Wednesday, 12/21/2005, Indianapolis, Indiana-based Eli Lilly and Company was treated to truthification, in connection with their illegal promotion (misbranding) of pharmaceutical drug EVISTA; (FDA approved for prevention and treatment of osteoporosis in post-menopausal women), in the:

a. prevention in risk of breast cancer

b. reduction in risk of breast cancer

Alleged in information, promoted drug as effective for reducing risk of breast cancer EVEN AFTER PROPOSED LABELING FOR THIS USE SPECIFICALLY REJECTED by FDA [1]

GorskGeek, being the breast cancer oncology specialist he claims to be, and so concerned about breast cancer patients that he is that “guy” who speaks out passionately about issues like the 10-year American Cancer Society Cancer Facts & Figures, “Estimated Breast Cancer Deaths for Women”, which reflect that in 2002, 39,600 (15%) women were estimated to die from breast cancer, and this year, 2013, the estimate is 39,620 (14%), which is 20 women MORE than 10-years ago, and who rails tirelessly about the ACS’s “Estimated New Breast Cancer cases in Women”, which 10-years ago was 203,500 (31%) in 2002, and now, in 2013 is 232,340 (29%), which is ONLY
28,840 MORE
than 10-years ago [2]

Now THAT’s progress !

GorskGeek, of course, must accomplish all this under his breath

But I’m sure you’re wondering, dear reader, what was GorskGeek’s outraged blog about this American pharmaceutical manufacturer coughing up $36 MILLION ?

Well, let me tell you … just as soon as I find it

Wait for it

Wait for it

Wait for it

GorskGeek was unable to bring himself to blog about Evista until exactly one year later, on 12/21/2006, and even then, he was “mum’s the word” about the breast cancer claims [3]

Perhaps GorskGeek just “knew” that eventually Evista would finally be approved by the FDA for Eli Lilly’s preventing or reducing risk of breast cancer claims on 9/13/2007, and who were those paper-pushing FDA apparatchiks to prevent Lilly from implementing their “Internal business plan” ? [4-9]

GorskGeek wouldn’t want to damage his slim and non-existent chance of getting some Eli Lilly money for research, by blogging anything that might in any way be possibly construed as him saying anything negatory about the BIG Pharma teat he longs to suck off of

After all, Bob ‘n’ Weave Blaskiewicz (who sees every molehill as a mountain), did say about GorskGeek, 9/28/2013 [10]:
——————————————————————
1:58:04
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“But he is a, the thing is, the thing is, you thing you have to understand is Gorski, Gorski is a genuine expert, in matters re re regarding on oncology studies

“I mean, he has a”

“He, He’s able to convince people, he’s able to convince people, on the strength of his record, to give him money to carry out research

“People who know what they’re talking about”

“To give him money to carry out his research”

“Right ?”
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1:59:00
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Yeah, right

Bobby 🙂

GorskGeek is hoping for a Happy Thanksgiving Golden Parachute; which is where he helps whistleblow about illegal BIG Pharma activity regarding some drug(s), which leaves him as the beneficiary of some funds like Mr. H. Dean Steinke, former Merck employee and his $68,190,000 MILLION from the federal government and states share of settlement amounts:
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$44,690,000 MILLIONMr. H. Dean Steinke, former Merck employee from federal share of settlement amount (1997 – 2001)
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$23.5 MILLIONMr. H. Dean Steinke, former Merck employee from the states share of settlement amount (1997 – 2001)
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Next, GorskGeek goes off on his fave autism prescription antipsychotic drug Risperdal, and the 11/4/2013, Monday, allegations concerning Global health care giant Johnson & Johnson (J&J) and its subsidiaries, $2.2 BILLION + fine regarding J&J Subsidiary Janssen (1999 – 2005) actions [11]
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REFERENCES:
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[1] – 12/21/2005
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EVISTA (FDA approved for prevention and treatment of osteoporosis in post-menopausal women)
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Eli Lilly and Company, Indianapolis, Indiana-based company
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12/21/2005, Wednesday
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$36 MILLION
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In connection with illegal promotion of pharmaceutical drug
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Pleading guilty to criminal count of violating Food, Drug, and Cosmetic Act by misbranding drug
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In addition to criminal plea
agreed to settle civil Food, Drug, and Cosmetic Act liabilities by entering into consent decree of permanent injunction
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Charged in criminal information filed with violation of Food, Drug, and Cosmetic Act, following investigation by Food and Drug Administration’s (FDA) Office of Criminal Investigations
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Plea agreement signed by Lilly and United States

Complaint for permanent injunction

Consent decree of permanent injunction signed by company and United States
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Information alleges 1st year’s sales of drug in U.S. were disappointing compared to original forecast
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According to information
10/1998 – company reduced forecast of drug’s 1st year’s sales in U.S. from $401 million to $120 million
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Internal business plan noted:

“Disappointing year versus original forecast.”
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Information alleges in order to expand sales of drug, Lilly sought to broaden market for drug by promoting it for unapproved uses
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Information alleges strategic marketing plans and promotion touted drug as effective in preventing and reducing risk of diseases for which drug’s labeling lacked adequate directions for use
——————————————————————
According to information: Evista
1. brand team
2. sales representatives
promoted drug for:
a. prevention in risk of breast cancer
b. reduction in risk of breast cancer
c. reduction in risk of cardiovascular disease
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Under provisions of Food, Drug, and Cosmetic Act, drug misbranded when labeling didn’t bear adequate directions for each of intended uses
——————————————————————
Alleged in information, promoted drug as effective for reducing risk of breast cancer even after proposed labeling for this use specifically rejected by FDA
——————————————————————
Information alleges executed illegal conduct using number of tactics, including:

1. One-on-one sales pitches by sales representatives promoting drug to physicians about off-label uses of drug

2. Sales representatives trained to prompt or bait questions by doctors in order to promote drug for unapproved uses

3. Encouraging sales representatives promoting drug to send unsolicited medical letters to promote drug for unapproved use to doctors on their sales routes

4. Organizing “market research summit’ during which drug was discussed with physicians for unapproved uses, including reducing risk of breast cancer

5.
a. Creating
b. distributing
to sales representatives “Evista Best Practices” videotape, in which sales representative states “Evista truly is the best drug for the prevention of all these diseases” referring to:

1). osteoporosis
2). breast cancer
3). cardiovascular disease
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Complaint for permanent injunction alleges executed illegal conduct using number of tactics, including:

1. Training sales representatives to promote drug for prevention and reduction in risk of breast cancer by use of medical reprint in way that highlighted key results of drug and thereby promoted drug to doctors for unapproved use

2. Some sales representatives were instructed to hide disclosure page of reprint which noted:

a. “All of the authors were either employees or paid consultants of Eli Lilly at the time this article was written,”

b. “The prescribing information provides that “The effectiveness of [Evista] in reducing the risk of breast cancer has not yet been established.””

3. Organizing “consultant meetings” for physicians who prescribed drug during which unapproved uses of drug discussed

4. Calculating incremental new prescriptions for doctors who attended Evista advisory board meetings in 1998

5. advisory board meetings included discussion of unapproved uses for drug

6. By measuring and analyzing incremental new prescriptions for doctors who attended advisory board meetings, Lilly was using this intervention as tool to promote and sell drug
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In addition to agreeing to plead guilty to criminal information and plea agreement signed by Lilly, settlement with United States includes following components:

(a) agreed to settle civil Food, Drug, and Cosmetic Act liabilities by entering into consent decree of permanent injunction

(1). As part of consent decree, agreed to comply with terms of permanent injunction, which will require company to implement effective training and supervision of marketing and sales staff for drug, and ensure any future off-label marketing conduct is detected and corrected

(2). agreed to be permanently enjoined from directly or indirectly promoting drug for use in:

a. preventing or reducing risk of breast cancer

b. reducing risk of cardiovascular disease

c. or for any other unapproved use in manner that violates Food, Drug, and Cosmetic Act unless and until FDA approves drug for additional use or uses
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(b) as part of consent decree, agreed to hire and utilize independent organization to conduct reviews to assist Lilly in assessing and evaluating Lilly’s

1. systems
2. processes
3. policies
4. procedures
relating to promotion of drug and company’s compliance with consent decree
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FDA made following announcement to postmenopausal women who have taken drug for prevention or treatment of osteoporosis:
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“No postmenopausal woman who has taken Evista for the prevention or treatment of osteoporosis is affected by this action, as this matter today relates only to unapproved uses of Evista.”
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Defendant agreed to plead guilty to charge in information
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Defendant agreed to resolve complaint for permanent injunction by agreeing to consent decree of permanent injunction
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http://www.justice.gov/opa/pr/2005/December/05_civ_685.html
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[2] – 11/13/2013 – The War on Cancer (I don’t think it means, what you think it says it means) #Winning?:
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https://stanislawrajmundburzynski.wordpress.com/2013/11/13/httpcancer-orgacsgroupscontentepidemiologysurveilancedocumentsdocumentacspc-036845-pdf/
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[3] – 12/21/2006 – On the messiness of evidence-based medicine
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http://scienceblogs.com/insolence/2006/12/21/the-messiness-of-evidencebased-medicine/
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[4] – 9/13/2007FDA Approval for Raloxifene Hydrochloride (Brand name(s): Evista®): Approved for breast cancer risk reduction:
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http://www.cancer.gov/cancertopics/druginfo/fda-raloxifene-hydrochloride
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[5] – 9/14/2007FDA Approves New Uses for Evista: Drug Reduces Risk of Invasive Breast Cancer in Postmenopausal Women:
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http://www.fda.gov/newsevents/newsroom/pressannouncements/2007/ucm108981.htm
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[6] – 9/17/2007Evista Approved for Reducing Breast Cancer Risk:
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http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048474.htm
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[7] – 2007
——————————————————————
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020815s018lbl.pdf
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[8]
——————————————————————
http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088593.pdf
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[9] – 2007
——————————————————————
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022042lbl.pdf
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[10] – 10/18/2013 – Deconstructing Dr. David H. (Orac) Gorski – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/18/deconstructing-dr-david-h-orac-gorski-september-28-2013-the-skeptics-burzynski-discussion-by-bob-blaskiewicz-21951/
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[11] – 11/4/2013
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http://www.justice.gov/opa/pr/2013/November/13-ag-1170.html
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All’s fair in Drugs and War

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GlaxoSmithKline
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$3 BILLION
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7/2/2012
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(4/1998 – 8/2003)
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United States alleges GSK participated in
preparing
publishing
distributing

misleading medical journal article that misreported that clinical trial of drug demonstrated efficacy in treatment when study failed to demonstrate efficacy
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At same time, United States alleges, GSK didn’t make available data from 2 other studies in which drug also failed to demonstrate efficacy
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(2001 – 2007)
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United States alleges GSK failed to include certain safety data about drug in reports to FDA meant to allow FDA to determine if drug continues to be safe for approved indications and to spot drug safety trends
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missing information included data regarding certain post-marketing studies
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data regarding 2 studies undertaken in response to European regulators’ concerns about safety of drug
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United States alleges GSK stated drug had positive cholesterol profile despite having no well-controlled studies to support that message
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Johnson & Johnson (J&J) and subsidiaries, Janssen Pharmaceuticals Inc. and Scios Inc.
Janssen Pharmaceutica Products, L.P.
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$2.2 BILLION +
——————————————————————
11/4/2013, Monday
——————————————————————
Johnson & Johnson (J&J) and Janssen
——————————————————————
complaint alleges J&J and Janssen were aware drug posed serious health risks, but companies downplayed these risks
——————————————————————
For example, when J&J study of drug showed significant risk of strokes and other adverse events in patients, complaint alleges Janssen combined study data with other studies to make it appear there was lower overall risk of adverse events
——————————————————————
year after J&J received results of 2nd study confirming increased safety risk for patients taking drug, but hadn’t published data, one physician who worked on study cautioned Janssen
——————————————————————
“[a]t this point, so long after [the study] has been completedwe must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”
——————————————————————
complaint alleges Janssen knew patients taking drug had increased risk, but nonetheless promoted drug as “uncompromised by safety concerns
——————————————————————
When Janssen received initial results of studies indicating drug posed same risk as other antipsychotics, complaint alleges company retained outside consultants to re-analyze study results and ultimately published articles stating drug was actually associated with lower risk
——————————————————————
J&J and another of its subsidiaries, Scios Inc.
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8/2001 – FDA approved drug to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity
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approval based on study involving hospitalized patients experiencing severe heart failure who received infusions of drug over average 36-hour period
——————————————————————
complaint alleged Scios had no sound scientific evidence supporting medical necessity of outpatient infusions and misleadingly used small pilot study to encourage serial outpatient use of drug
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Abbott Laboratories Inc.
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$1.5 BILLION
——————————————————————
5/7/2012, Monday
——————————————————————
(2001 – 2006)
——————————————————————
company marketed drug in combination with atypical antipsychotic drugs even after its clinical trials failed to demonstrate adding drug was any more effective than atypical antipsychotic alone for that use
——————————————————————
1999 – forced to discontinue clinical trial of drug due to increased incidence of adverse events, including
somnolence
dehydration
anorexia
experienced by study participants administered drug
——————————————————————
funded 2 studies of use of drug
both failed to meet main goals established for the study
——————————————————————
When 2nd study failed to show statistically significant treatment difference between antipsychotic drugs used in combination with drug and antipsychotic drugs alone, waited nearly 2 years to notify sales force about study results and another 2 years to publish results
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AstraZeneca LP / AstraZeneca Pharmaceuticals LP
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$520 MILLION
——————————————————————
4/27/2010, Tuesday
——————————————————————
engaged doctors to conduct studies on unapproved uses of drug
——————————————————————
recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies doctors in question didn’t conduct
——————————————————————
then used
studies
articles

as basis for promotional messages about unapproved uses of drug
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REFERENCE:
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11/26/2013 – United States Department of Justice (DOJ) versus BIG Pharma: BIG Pharma fought the law, and the law won ?:
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https://stanislawrajmundburzynski.wordpress.com/2013/11/26/united-states-department-of-justice-versus-big-pharma-big-pharma-fought-the-law-and-the-law-won/
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