Burzynski: Responses to January 7th to March 15th, 2013 (FDA-483) Inspectional Observations (20 pages)

FDA 483 inspection observations, as redacted by the FDA, which are based on recent inspections and the corresponding responses to those FDA 483 observations
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Responses to January 7th to March 15th, 2013 (FDA-483) Inspectional Observations (20 pages)
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Burzynski_Clinic_redacted_483_response.pdf
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http://www.burzynskiclinic.com/images/stories/Burzynski_Clinic_redacted_483_response.pdf
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http://www.burzynskiclinic.com/
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Burzynski: obviously we knew that the FDA inspectors will always find something wrong

“Of course, in order to be, eh, in, eh, in order to do what I was doing, it was necessary for me to have inspection, by the inspectors, approved by the FDA, who check our manufacturing facility, and, ah, certify that what ever we do, we do right, and there are no discrepancies”

“So this was obviously something, very difficult, because obviously we knew that the FDA inspectors will always find something wrong, you know”
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12/2011Pete Cohen chats with Dr. Stanislaw Burzynski
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https://stanislawrajmundburzynski.wordpress.com/2013/11/09/pete-cohen-chats-with-dr-stanislaw-burzynski/
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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 +
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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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Marsha Bauman Shaw, your “15 seconds of Fame” about your Burzynski “allegations” on USA TODAY’s Facebook comments page, starts NOW

20131123-224729.jpg
Marsha Bauman Shaw “claims” on USA TODAY’s “Doctor accused of selling false hope to families” article’s Facebook comments, that she worked for Burzynski 17 years ago (1996):

“I know first hand fraud perpetrated when he was being investigated by the FDA and taken to court while I worked there”

Marsha
Marsha
Marsha

I do NOT find your name anywhere, associated with testifying for the U.S. Gubment in Burzynski’s 1997 criminal case

Is that because you’re no Edward Snowden, and so you put your “money-making concern” before your concern for your country ?

Marsha
Marsha
Marsha

Your “15 seconds of Fame” starts NOW