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 +
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11/4/2013, Monday
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Johnson & Johnson (J&J) and Janssen
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complaint alleges J&J and Janssen were aware drug posed serious health risks, but companies downplayed these risks
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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
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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
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“[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.”
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complaint alleges Janssen knew patients taking drug had increased risk, but nonetheless promoted drug as “uncompromised by safety concerns
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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
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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
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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
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5/7/2012, Monday
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(2001 – 2006)
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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
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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
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funded 2 studies of use of drug
both failed to meet main goals established for the study
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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
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4/27/2010, Tuesday
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engaged doctors to conduct studies on unapproved uses of drug
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recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies doctors in question didn’t conduct
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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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Critiquing: Families run out of hope, money after cancer treatments (USA TODAY NEWS, NATION, Liz Szabo, USA TODAY)

USA TODAY
Liz Szabo
Michael Stravato
Jerry Mosemak
Robert Hanashiro

Before you write a Hack Piece
Check Your Facts Please

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The 3rd, and thankfully final segment of USA TODAY’s “hit-piece” of irresponsible yellow journalism about Dr. Stanislaw R. Burzynski [1], contains the following:
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“Patients stay in hotels while visiting him”
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Pete Cohen made this movie about his and
Hannah Bradley’s trip to the Burzynski Clinic

It does NOT look like they stayed in a hotel [2]
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The article continues:
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“If children deteriorate, they often end up in the closest emergency room, said physician Jeanine Graf, director of the pediatric intensive care unit at Texas Children’s Hospital in Houston, who says she has treated at least a dozen of Burzynski’s patients
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In the 2nd segment of USA TODAY’s yellow journalism “hit-piece,” the reader was advised that Burzynski had treated [3]:
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“ . . . more than 8,000 patients since 1977.”
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Physician Jeanine Graf, “says she has treated at least a dozen of Burzynski’smore than 8,000 patients,”

This means that Dr. Graf has treated LESS THAN 0.15% of Burzynski’s patients
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The article indicates that:
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“Typically, Graf sees Burzynski’s patients after they have become unresponsive, unable to open their eyes or breathe on their own”

“Graf says she’s never seen Burzynski attending to them”
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Why would she ?

Does she ride in the ambulance to and from the clinic ?

As the article makes clear:

“While Burzynski often meets patients on their first trip to the clinic, Jaffe said he is

“not the treating physician of the clinic’s patients”

“The doctors on Burzynski’s staff have admitting privileges at local hospitals and “attend to patients as needed,” Jaffe said”
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And she continues:
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“And describing her personal experience with Burzynski’s patients, Graf says,”

“I’ve never seen one survive long-term.”
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Are we supposed to believe that pediatric physician Jeanine Graf keeps track of the “more than 8,000 patients” that the article claims Burzynski has treated ?
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Continuing on, the article also claims:
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“The unlucky ones end up broke, spending everything on medicine, airfare, hotel rooms and meals while in Houston, Graf says

“Burzynski’s attorney, Richard Jaffe, notes that all cancer care is expensive”

“I think the clinic’s policies are a lot more charitable than the big institutions,” Jaffe says”
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6/25/2013 – Medical Bills Are the Biggest Cause of US Bankruptcies [4]

“Bankruptcies resulting from unpaid medical bills will affect nearly 2 million people this year—making health care the No. 1 cause of such filings . . . according to new data”

“. . . estimates that households containing 1.7 million people will file for bankruptcy protection this year

“Even outside of bankruptcy, about 56 million adultsmore than 20 percent of the population between the ages of 19 and 64—will still struggle with health-care-related bills this year . . .”

“Despite the anticipated 2013 dip, such bankruptcies represent about three out of every five filings
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2007 – How Many Americans Go Bankrupt Due to Medical Purposes Each Year? [5]

“2007, a Harvard study shows that at least 60% of bankruptcies are related to medical bills

“Even people with health insurance are filing bankruptcy”

“Insurance premiums, deductibles, co-pay, and out of pocket expenses cause medical bills to drown individuals and families in medical debt”

“Harvard also discovered that 75% of those filing bankruptcy for medical reasons had health insurance

“It is clear that having health insurance is no guarantee against carrying debt related to health care”
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Burzynski has treated more than 8,000 patients since 1977

8,000 divided by 36 years equals an average of:

222 patients per year

Burzynski is obviously NOT the problem
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Liz Szabo, Michael Stravato, Jerry Mosemak, and Robert Hanashiro

Don’t quit your day jobs

USA TODAY needs to generate readership somehow !!!
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Sarcasm . . . deal with it
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REFERENCES:
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[1] – 11/15/2013
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http://www.usatoday.com/story/news/nation/2013/11/15/jeanine-graf-cancer-children/2994675/
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[2]Hannah’s Anectdote:
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[3] – 11/16/2013 – Critiquing: Doctor accused of selling false hope to families (USA TODAY NEWS, NATION, Liz Szabo, USA TODAY):
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https://stanislawrajmundburzynski.wordpress.com/2013/11/16/httpwww-usatoday-comstorynewsnation20131115stanislaw-burzynski-cancer-controversy2994561/
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[4] – 06/25/13 2:29 PM ET—By CNBC’s Dan Mangan @danpostman
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http://www.cnbc.com/id/100840148
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[5] – 2007 – Written by James Hirby | Fact checked by The Law Dictionary staff
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http://thelawdictionary.org/article/how-many-americans-go-bankrupt-due-to-medical-purposes-each-year/
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