"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

courtesy http://science.nationalgeographic.com/science/photos/aids/#/aids-patient_801_600x450.jpg

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

courtesy http://www.stanford.edu/group/virus/flavi/2004gallo/hepatitisc.html 

     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

ALL THE GAB ABOUT GABA: NATURE'S TRANQUILIZER BY REV BARBARA SEXTON "The Biblical Biochemist-Where Science Meets the Cross" www.DearOnesHealingMinistry.blogspot.com

Dear Ones:
     With all the uncertainty in the world today no doubt many patients are feeling a great deal of anxiety and I would like to start recommending some natural, safe supplements for you!
     For generalized anxiety, take 750 mg per day of GABA (gamma- Aminobutyric acid). Don't bother taking more than 750 mg of GABA per day, because more will not work better, due to the biochemistry of the way GABA is metabolized. GABA is what is known as an 'inhibitory neurotransmitter' (a major one, in fact) in humans and other mammals.
     Pharmaceutical 'versions' (analogues) of GABA-like compounds include Gabapentin (brand name Neurontin) and Pregabalin (brand name Lyrica). Both of these are anticonvulsant drugs used for neuropathic pain.
     You may ask why biologically active GABA, itself, is not regularly used by the medical profession, especially since it is safer and cheaper than both Neurontin and Pregabalin? You might ask why physicians don't even give GABA a try, before prescribing a more toxic, perhaps 'stronger' pharmaceutical knockoff?
     Well, when you consult your physician about my recommendation here, as I always advise, please do inquire and let me know what answer you get!  To date, I've none that I can believe at all.
     You may want to experiment with GABA a couple of hours before bedtime when first starting. However, it is my experience that people who are over-stressed can even take GABA in the morning and get day-long stress relief without tranquilizers, etc.
     I hope this information helps you. Stay tuned for additional anti-anxiety recommendations for you with all the stress we are exposed to these days. I promise that you will get safe, effective relief by using what I recommend.
     Remember to consult your physician before taking anything, of course. I pray that your healthcare provider is enlightened and has some knowledge of natural methods and is willing to work with you to protect and improve you health.  As with all new foods and new medications, health supplements (vitamins, minerals, herbs, amino acids, etc) must be experimented with carefully at first, before maximum dosages are taken. 
     My rule of thumb is always: LISTEN TO YOUR BODY!  If whatever you put into your body doesn't 'feel right' to you or if it disagrees with you in any way, stop taking/applying/exposing yourself to that substance immediately and consult your healthcare advisor.  No matter what your doctor or other healthcare advisor tells you, you know your body best.  You know when something is or isn't agreeing with you, so don't let anyone tell you otherwise.  No two persons are exactly, 'exactly' alike.
     When it comes to the supplemental vitamins, minerals, herbs, amino acids, etc that I recommend, I can assure you that I keep a weather eye to any and all potential side-effects (if any).  I will tell you when something (such as the temporary peppery sensation kava kava gives to the tongue and mouth) is likely to give you a given sensation or reaction.  In most cases, this will be evidence that you have a potent formulation which is actually working for you... unlike the microdoses in some RDA formulations, barely better than nothing I guess you could say. 
     Another factor I always consider is potential allergenicity.  I always attempt to recommend the most hypoallergenic form of everything and will alert you if there is any 'cross-over allergy' potential. 
     It is my policy to--literally--do no harm in a quest for treatment and cure of any illness or disease.  I reject the construct, so often seen in traditional medicine,  that a fair amount of negative side-affects are off-set by potential benefits of some drug, procedure, test or treatment. 
     For example, I find unacceptable the fact that some anti-cancer regimens 'cure' one type of cancer while assuring that that same patient will almost certainly succumb to another type of cancer x number of years down the road--from the initial regimen itself!  Worse still, patients are either not told this or the fact is 'dumbed down', so the clinician can more readily achieve patient compliance from the start.  A few days/weeks here or there with something like cancer will not likely make a great deal of difference in one's overall outcome,  if that time is used to study and compare the best of both traditional and alternative medicine. 
     If a clinician puts the major rush on you, go elsewhere for your treatments.  There is almost never a need for an oncologist  or any other doctor to give you the bum's rush...Well, not unless you're at a national public DMV-like clinic as proposed under Obamacare, where the docs will have zero profit incentive to serve you better, in which case, good luck with that one.
     In my world, my least  favorite pharmaceuticals of all are the ones that are known carcinogens and whose major side effects include things like "stroke, heart attack, sudden death and other fatal events".  Are they kidding? No, they're not....talk about stress! 
     But with your daily 750 mg of GABA (gamma-Aminobutyric acid), expect to feel more calm after taking it.  And if you take it before bedtime, be sure to put your jammies on and brush first, so that you can drift off into a healthful, carefree sleep.
God Keep you well,
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross'
http://www.dearoneshealingministry.blogspot.com/
REV BARBARA RECOMMENDS:
1 GABA 750 MG TAB AT BEDTIME OR DURING THE DAY, IF SUITABLE
2-3 CHELATED CAL-MAG 500-250 MG TABS PER DAY, DEPENDING UPON DIET INTAKE
2 CAPS KAVA KAVA EXTRACT 250/50 MG (Extract/Whole Herb) UP TO 3 TIMES PER DAY (MAX SIX CAPS PER DAY)