Friday, January 21, 2011

"GENENTECH:Injectables Boniva, Fuzeon, Nutropin, Pegasys, and TNKase-Products Affected by Triad Alcohol Prep Products, Now A BAYER PRODUCT TOO (Betaseron)" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

HIV AIDS
Dear Ones:
     Here is an immediate follow-up to my yesterday's article about the huge recall of Triad 70% alcohol prep pads and swabs for use with injectable drugs.
     Triad pads are marketed in the US, Canada and Europe under the following brand names: Triad, Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin...and perhaps 'others'.
LINK: http://dearoneshealingministry.blogspot.com/2011/01/contaminated-alcohol-swabs-recalled-in.html
     Unfortunately for consumers of injectable drugs on the consumer level, a number of pharmaceutical companies are now being 'forced' to issue what are known as 'voluntary recalls' of their products which are 'co-packaged' with Triad-manufactured alcohol prep-pads and/or swabs.
     In the world of 'FDA-speak', the term 'voluntary recall' means that a manufacturer acknowledges a problem of some sort. They are 'agreeing' to act 'preemptively' (presumably for the benefit of the medical consumer) so as not to be FORCED to do so through the use of legal action on the part of the FDA.
     Typically, it benefits a manufacturer to 'cooperate' with the FDA (and other regulatory agencies).
     In the case here, Genentech has chosen to include alcohol pads/swabs from a subcontractor and therein lies the conundrum for Genetech and doubtless other companies like it.
     The conundrum is this: While the medical consumer 'reads' that Genetech assures them that the drugs they manufacture themselves are SAFE, they DO acknowledge that the 'alcohol prep pads and swabs' packaged with those drugs MAY NOT BE.
     This, of course, raises the following questions:


1--Why in Heaven's name didn't Genentech DO THEIR OWN INDEPENDENT STERILITY AND STABILITY STUDIES ON THE TRIAD PRODUCTS THEY PACKAGED WITH THEIR PRODUCTS? Or...

2--If Genetech DID DO the above studies on the Triad pads they chose to include in their packaging...WHAT WERE THE RESULTS REGARDING THE EFFICIENCY AND EFFICACY OF THE TRIAD PRODUCTS TO PERFORM ACCORDING TO INDUSTRY STANDARDS?


3...In other words, did anyone at Genentech check to 'see' if the Triad pads they packaged with Genentech's Boniva Injection, Fuzeon, Nutropin A.Q. Pen, Pegasys, and TNKase were actually capable of DOING the job they are meant to do, i.e. to 'work' as a suitable antiseptic on the skin?


4--Perhaps Genentech chose to 'farm out' the Triad Product STERILITY and STABILITY studies to an outside, INDEPENDENT lab. If so, what were the results? Was the testing comprehensive and conclusive? Has this independent lab been 'tested and certified' as meeting the standards for independent testing facilities, which includes maintaining qualified employees?
     I sound like a task-master here and there's a reason for it.
     Much of what I am writing about here is not 'common knowledge'. Consumers need to know these things in order to preserve and maintain their good health.

hepatic cirrhosis/Hepatits C

     These comments stem from my own personal experience working with federal regulatory agencies in the fields of drug and cosmetic manufacturing.
     One thing I constantly emphasize is that we ALL must advocate for ourselves and others in this day and age of 'mixed-messages' and 'signals' on the subjects of Health Care reform and medical coverage and treatment.
     No one will disagree that things can get 'confusing', so please read on and empower yourself.
     First of all, the FDA really does try to protect the consumer, if not literally, in theory at least.
LINK: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm
     Secondly, company executives and chief R & D and QC/QA 'officers' are held PERSONALLY ACCOUNTABLE for each and every thing they 'sign off' on. We in the 'scientific community' know that our 'reputations' with the various government alphabet agencies is of the 'cradle-to-grave' type of responsibility.
     This means that the quality and integrity of your work in the lab as far as the feds are concerned travels 'with you' over the course of your career and then some.
     I know, having been interviewed, deposed and 'asked to testify' in cases from years gone past.
     To all young researchers, I say, "Don't sign off on ANYTHING that you are not prepared to vigorously defend at any time in the future. KNOW your stuff and be upstanding and accountable."
     Being a 'chief chemist' as I was is all well and good and calls for a great deal of accountability since I was the one who drafted, tested and 'justified' the 'protocols' our company used for testing in-house.
     Because of that and the fact that we were constantly developing new products, I got to know the FDA (and v.v.) pretty well.
     Eventually, I grew quite 'used' to being 'shadowed' at work and almost enjoyed the 'challenge' of working under such pressure.
     But I was also the LAB SUPERVISOR, which meant that I had to 'sign off' on not just the chemistry part of things, but on the microbiology and hard components (packaging, wound pad material, etc) departments' work, as well.
     My strong micro and biology background served me well and I was capable of understanding what I was called to 'sign-off' on before it got to the 'administration', after which point things were pretty much out of 'the lab's hands'.
     The reason for this is that a company V.P. as well as the President had the power to 'approve' of and 'release' anything at all they chose, no matter what the 'lab' had to say about things.
     I am sure that you, dear Readers, understand that manufacturing is MONEY and that there is a natural 'temptation' to 'okay' product with minor defects.
     Human nature being what it is, unscrupulous manufacturers will do the same even in cases of 'severe defect', for such is the sorry state of our species.
     Not surprisingly, some manufacturers play a game of 'cat and mouse' with the FDA with the hope that no defective product and/or packaging will be detected.
      In most cases, no harm is done and we have all been the victims of purchasing less-than perfect products.
     But there are very real 'cut-off points' where a major health and well-being concern comes into focus. Such is the case where an ALLEGEDLY contaminated alcohol prep pad or swab intended to CLEANSE AN AREA OF SKIN is in circulation.
     I say 'allegedly' because it is unknown at this time whether the Bacillus cereus contamination is widespread through-out all the Triad-manufactured alcohol pads and swabs.
     If so, this means that every pharmaceutical company who 'uses' these Triad pads with their injectables has a major, major recall problem, no matter how much they try to 'tone it down' and I'll tell you why.
     The very fact that 'bad wipes' are packaged with some injectables will make the average consumer wary of the injectable, as well.
     It may be true that all of Genetech's products are, indeed, sterile...but it begs the fact that the accompanying antiseptic pads/swabs may not be. Just what does that say about Genentech's Quality Control over-all?
     In cases like this, I'll tell you what's going on 'behind the scenes'. Genentech is having to inform consumers and keep them up-to-date on the status of their recall situation.
     And the FDA likely is asking about the independent testing of the Triad pads, as in 'did Genentech do any at all, either in-house or by a third party or both?
     The FDA is likely asking Genentech to 'pull their retains' (retained samples) of the following drugs they manufacture:

--Boniva Injection (ibandronate sodium)-used to treat osteoporosis

LINK: http://www.gene.com/gene/products/information/boniva/pdf/Injection_pi.pdf

--Fuzeon (enfuvirtide)-for treatment of HIV-1 infection
LINK: http://www.gene.com/gene/products/information/fuzeon/pdf/pi.pdf

--Nutropin A.Q. Pen (somatropin (rDNA origin)-used to treatment of growth hormone deficiency in children and adults, growth failure associated with chronic renal insufficiency prior to kidney transplantation, short stature associated with Turner syndrome, and long-term treatment of idiopathic short stature.
LINK: http://www.gene.com/gene/products/information/opportunistic/nutropin-aq/insert.jsp

--Pegasys ((Peginterferon alfa-2a)-an 'alpha-interferon' used to treat Hepatitis C
LINK: http://www.gene.com/gene/products/information/pegasys/pdf/pi.pdf

--TNKase ( Tenecteplase)-a 'thrombolytic' or clot-busting agent used in cases of acute myocardial infarction ('heart attack'). TNKase is which is a synthetic form of the well-known naturally derived 't-PA' (tissue plasminogen activator)
LINK: http://www.gene.com/gene/products/information/pdf/tnkase-prescribing.pdf
      
     Genentech will also be asked to retest and provide samples of the raw materials...and especially the WATER...used in then manufacture of the injectables above.
     The FDA will want full micro and chem panels done on these, not so much, perhaps, because the FDA thinks the injectables are contaminated with B. cereus or some other microbe, but because in it's 'voluntary recall notice', Genentech IS STATING THAT 'THEIR PRODUCTS ARE SAFE'....even as they state the Triad pads accompanying their products may not be!
     THE FEDS WILL TELL GENETECH TO 'PROVE IT'.
     Genentech, like Triad, will have to 'prove' they are utilizing 'GMP's--Good Manufacturing Practices, et. al.
     As I've said previously, we don't know of the extent and origin of the Bacillus cereus contamination of Triad-manufactured alcohol prep pads and swabs, but I'm following up on it.
     Perhaps it will 'sizzle out' as a low-grade incident.
     And perhaps not.
     But as it stands today, yet a THIRD recall notice has gone out to a company besides Genentech and that is for Bayer HealthCare Pharmaceutical for it's Betaseron. Also known as interferon beta 1-b), this is ALSO packaged with Triad's 'potentially contaminated' alcohol prep products.
LINK: http://www.fda.gov/Safety/Recalls/ucm240558.htm 
     Betaseron is used for cases of 'relapsing multiple sclerosis'. By definition, the patients needing Betaseron are ALREADY suffering from improperly functioning immune systems.
      The last thing they need is to contract a cutaneous, subcutaneous or even systemic INFECTION courtesy of contaminated alcohol pads.
     I pray that all parties involved work fairly, swiftly and expediently to remediate this situation so that none are hurt. I pray that the 'best scientific minds' are on this.
     Most of all, I pray that Genentech and Bayer will for once discard their industry's incessant consideration of the bottom-line and 'do right' by the souls who use their products.
     If that requires total product replacement so that patients are comfortable using their injectables, may these drug manufacturers be of good conscience and see to those replacements at no cost to the patients.
     Please be sure to seek the advice of your personal Health care provider with any questions you may have specific to you and your loved ones!*
God Bless & Keep you as strong and healthy as you can be!
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
http://www.dearoneshealingministry.blogspot.com  
*DISCLAIMER FOR HEALTHCARE PROFESSIONALS & THEIR PATIENTS
Please understand that I am a biochemist and alternative healthcare provider with several decades of experience in the field of biomedical science. The information provided at http://www.dearoneshealingministry.blogspot.com/ and in any emails sent out by BarbaraKSexton@aol.com is for educational and entertainment purposes only and is in no way intended to replace the advice of your regular medical doctor or healthcare provider and you are urged to follow his/her advice. You are encouraged to share the contents at http://www.dearoneshealingministry.blogspot.com/ and of any e-mails specifically sent to you by Reverend Barbara Sexton, M.Sc. with your medical doctor and/or other healthcare providers with the understanding that all Intellectual Property Rights belong to Reverend Barbara Sexton, M.Sc. As such, this intellectual property may not be copied, transferred, transmitted, utilized or distributed by or for anyone else without my express permission and in accordance with all applicable laws. Any case-specific e-mails sent out by Reverend Barbara Sexton, M.Sc. are for the individuals for whom they are intended only and are subject to the Intellectual Property Rights restrictions above. Healthcare professionals may contact BarbaraKSexton@aol.com for terms, restrictions and fees (if any) if they wish to utilize this intellectual property for themselves or in their practices. Exceptions: FREE NEWSLETTER RECIPIENTS may share their copies with friends and family. Healthcare Professionals may sign up for the SAME FREE Dear Ones Healing Ministry NEWSLETTER by sending their name, address and email address to Reverend Barbara Sexton, M/Sc. at BarbaraKSexton@aol.com Public Domain: This disclaimer published 3/8/10 on http://www.dearonesministry.blogspot.com


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