Example of a patient whom was given bogus Lupron (confirmed by leading onco-doc whom found it out)

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zufus
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Date Joined Dec 2008
Total Posts : 3149
   Posted 2/15/2009 1:35 PM (GMT -6)   
 At the PCRI-Prostate Cancer Research Institute 2006 meeting, leading onco-docs attending (Sartor, Myers, Tucker, Vogelzang?, another) and Dr. Chodak a urologist, too. Like a town hall meeting and symposium together, questions sometimes directed from the moderator(then it was Harry Pinchot) or audience/patients.
 
A patient was on Lupron via his docs treatments and then suddenly his psa rose (unexpectantly). Luckily this patient consulted with one of these oncologists (Dr. Tucker) for confirmation on psa rise. Onco-docs not only run blood tests, they also test your urine, and  testostorone levels to see if LHRH (like Lupron) is still working as it should to near castrate levels (a uro-doc does not usually do these types of tests, urine maybe). Well testostorone was way high for a guy whom is 'taking' Lupron, so the wise onco-doc traced back the sale of the merchandise.....they are given 'Lot' numbers and such.....this one had a bogus number and was actually a counterfit drug. Was not mentioned as to whom was respondsible or if anyone got caught. Surely is suspecious. devil idea
 
The moral is there can even be bogus and counterfit drugs out there, who knows who slipped it into the mix, delivery guy, sales-rep, at manufacturer level, an ingenious thief whom stole the real stuff and sold it elsewhere while dropping off his counterfit look alike, or maybe even the doc pulling off such a thing (just conjecture on these).
 
Probably this is a rare event, it might not have been caught without the knowledge of an onco-doc.
 
 


 

Post Edited (zufus) : 2/17/2009 7:12:12 PM (GMT-7)


Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25380
   Posted 2/15/2009 1:46 PM (GMT -6)   
Isn't this the very reason the FDA doesn't want, and strongly encourages people not to buy mail order drugs from outside the US? I am aware of the massive cost savings on certain drugs, but the fear of getting bogus or polluted drugs would worry me. Contanimated drugs could kill you, or if you were getting fake drugs, then it could hinder or worsen your condition. Just my thought.

David
Age 56, 56 at DX, PSA 7/7 5.8, 7/8 12.3
3rd Biopsy 9/8 Positive 7 of 7 cores pos, 40-90%, Gleason 7
Open RP surgery 11/14/8, Right nerves saved, 4 days hospital, staples out 11/24/8, 5th cath out on 1/19/9
Post-surgery Pathlogy Report:Gleason 3+4=7, pT2c, 42 grm, tumor 20%, Contained in capsular, clear margins, clear lymph nodes 
First PSA Post Surgery   2/9 .05
 
 


zufus
Veteran Member


Date Joined Dec 2008
Total Posts : 3149
   Posted 2/15/2009 2:33 PM (GMT -6)   
Right on David nobody needs fake or less than righteous drugs put into them. Even with herbal generic things they can get around the FDA and have been caught slipping in Rx or unknown drugs, that might be effective and.or harmful, but because they can get better sales, profits etc.
PC Spec from years ago was found to have estrogen drug within it, and done illegally, it got caught and banned. This will probably be revisited on another drug before to long. Mail order would be the easiest way to sell bogus stuff and get away with it, so buyer beware on such. caveat emptor
 


Tony Crispino
Veteran Member


Date Joined Dec 2006
Total Posts : 8128
   Posted 2/15/2009 7:26 PM (GMT -6)   
I may ask Gerry Chodak his thoughts about this in May as I will meet him personally. I have already had some internet exchanges with him and I included his video site in the Videos link I maintain here. On May 9th I will be in Miami with him at an open discussion for prostate cancer. I was invited to co-host with Rhonda Fine one of the breakout sessions by the Prostate Cancer Mission to give a patients perspective of the effects of prostate cancer treatment. I understand I will also be on the board with Dr. Chodak and as other well known doctors and consultants (Mike Scott) for a town hall QA session from the audience at the end of the seminar. These sessions will be video recorded and should be available on the net sometime this summer. http://pcmission.org/ is a HW approved site.

I am very honored by the request.  In some ways it's a shame to be considered qualified.

Tony


Age 46 (44 when Dx)
Pre-op PSA was 19.8 : Surgery at The City of Hope on February 15, 2007
Geason 4+3=7, Stage pT3b, N0, Mx
Positive Margins (PM), Extra Prostatic Extension (EPE) : Bilateral Seminal vesicle invasion (SVI)
HT began in May, '07 with Lupron and Casodex 50mg (2 Year ADT)
IMRT radiation for 38 Treatments ending August 3, '07
Current PSA (January 13, 2009): <0.1
 
My Journal is at Tony's Blog  
 
STAY POSITIVE!


zufus
Veteran Member


Date Joined Dec 2008
Total Posts : 3149
   Posted 2/16/2009 7:07 AM (GMT -6)   
That is great Tony, you are walkin in Harry Pinchots shoes, which would be no doubt humbling in the PCa world. Hey if we can get the video or get access or even buy it, some of us herein would be no doubt be interested. After seeing the videos on the 2006 & 2008 conferences of PCRI, I would say it is like being a fly on the wall amongest the most knowledgable onco and other docs, and their discussions and even possible disagreements on PCa issues. This shows people what is really going on out there in the PCa world. Lots of protocols and therapies for the patients whom failed first treatments.
 


Tony Crispino
Veteran Member


Date Joined Dec 2006
Total Posts : 8128
   Posted 2/16/2009 11:19 PM (GMT -6)   
Bob,
Those are kind words my friend. By I certainly am no Harry Pinchot...may he rest in peace. For those who don't know, Harry was a true fighter and advocate. So much so thet Us Too created an award in his name after he died from prostate cancer. Th eaward is meant to be presented annualy to a person who has dedicated their efforts in the cause of prostate cancer support and advocacy. The first winner last year was Ralph Valle. Well deserved.

Thank you Bob. That was very kind.

Tony
Age 46 (44 when Dx)
Pre-op PSA was 19.8 : Surgery at The City of Hope on February 15, 2007
Geason 4+3=7, Stage pT3b, N0, Mx
Positive Margins (PM), Extra Prostatic Extension (EPE) : Bilateral Seminal vesicle invasion (SVI)
HT began in May, '07 with Lupron and Casodex 50mg (2 Year ADT)
IMRT radiation for 38 Treatments ending August 3, '07
Current PSA (January 13, 2009): <0.1
 
My Journal is at Tony's Blog  
 
STAY POSITIVE!


Steve n Dallas
Veteran Member


Date Joined Mar 2008
Total Posts : 4831
   Posted 2/17/2009 6:29 AM (GMT -6)   
I have a Canadian friend that happens to be a surgeon and was born in India. I asked him about ordering on-line...His comments:
 
"Hey Steve .. hmm .. that's a reallllly slippery slope. Firstly, I dont trust foreign pharmacs at all .. particular given the pathetic condition Indian healthcare is at (I say this as a person from that country .. the truth is the truth .. and I'd rather be truthful to a friend than keep quiet) . It is a country that is mired in issues with spurious drugs, fake doctors (relax, my education was in Canada VIEW IMAGE) and doctors that make butchers look like gardeners (organ harvesting et al.) .. so in that sense . .I would rather stay away from meds from there. Look to Canada or Europe if you must go abroad."
I know most people swear by AllDayChemists....But I went with the "when in doubt - don't do it route."

Age 53   - 5'11"   205lbs
Overall Heath Condition - Good
PSA - July 2007 & Jan 2008 -> 1.3
Biopsy - 03/04/08 -> Gleason 6 
 
06/25/08 - Da Vinci robotic laparoscopy
Catheter in for five weeks.
Dry after 3 months.
 
10/03/08 - 1st Quarter PSA -> less then .01
01/16/09 - 2nd Quarter PSA -> less then .01
Surgeon - Keith A. Waguespack, M.D.
 


Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25380
   Posted 2/17/2009 8:28 AM (GMT -6)   
I fully agree with Steve on this one
Age 56, 56 at DX, PSA 7/7 5.8, 7/8 12.3
3rd Biopsy 9/8 Positive 7 of 7 cores pos, 40-90%, Gleason 7
Open RP surgery 11/14/8, Right nerves saved, 4 days hospital, staples out 11/24/8, 5th cath out on 1/19/9
Post-surgery Pathlogy Report:Gleason 3+4=7, pT2c, 42 grm, tumor 20%, Contained in capsular, clear margins, clear lymph nodes 
First PSA Post Surgery   2/9 .05
 
 


Steve n Dallas
Veteran Member


Date Joined Mar 2008
Total Posts : 4831
   Posted 2/17/2009 8:51 AM (GMT -6)   
It is a tough call...I was paying $12 each times 5 pills for Viagra each month...Would have loved to get a 100 pills for the next to nothing on-line prices..
Age 53   - 5'11"   205lbs
Overall Heath Condition - Good
PSA - July 2007 & Jan 2008 -> 1.3
Biopsy - 03/04/08 -> Gleason 6 
 
06/25/08 - Da Vinci robotic laparoscopy
Catheter in for five weeks.
Dry after 3 months.
 
10/03/08 - 1st Quarter PSA -> less then .01
01/16/09 - 2nd Quarter PSA -> less then .01
Surgeon - Keith A. Waguespack, M.D.
 


James C.
Veteran Member


Date Joined Aug 2007
Total Posts : 4462
   Posted 2/17/2009 11:00 AM (GMT -6)   
I've been using them for generic Viagra for 17 months now, 3 different orders, no problems whatsoever. Their manufacturers requirements are world-class, and they belong to and are accrediated by most, if not all the world accrediation agencies, except the FDA. The rest of the world seems able to survive safely using these accrediated agencies to safeguard their prescription drugs.
James C. Age 62
Co-Moderator- Prostate Cancer Forum
4/07 PSA 7.6, referred to Urologist, recheck 6.7
7/07 Biopsy: 3 of 16 PCa, 5% involved, left lobe, GS 3/3=6
9/07 Nerve sparing open RRP- Path Report: GS 3+3=6 Stg. pT2c, 110gms, margins clear
16 mts: ED- 50 mg Viagra 3X week, pump daily,Trimix .35ml 2X week continues
PSA's: .04 each 3 months


zufus
Veteran Member


Date Joined Dec 2008
Total Posts : 3149
   Posted 2/17/2009 12:02 PM (GMT -6)   
So for someone paying directly out of pocket especially, you might like saving $5000+- a year by doing the Canadian connection!  It is crazy stuff out there.

 


BillyMac
Veteran Member


Date Joined Feb 2008
Total Posts : 1858
   Posted 2/17/2009 8:48 PM (GMT -6)   
James C. said...
I've been using them for generic Viagra for 17 months now, 3 different orders, no problems whatsoever. Their manufacturers requirements are world-class, and they belong to and are accrediated by most, if not all the world accrediation agencies, except the FDA. The rest of the world seems able to survive safely using these accrediated agencies to safeguard their prescription drugs.


James C,
Re. the FDA approval issue,
Alldaychemist is a supplier of drugs manufactured by reputable and well known Indian pharmaceutical companies such as Ranbaxy, Cipla and Ajunta. Ranbaxy, one of the Indian manufactures of the generic ED drugs supplied by Alldaychemist , actually does have FDA approval to supply many various generic drugs into the U.S. There was a kerfuffle some time back when Ranbaxy was cautioned by the FDA over a couple of its plants. It was not about the quality of the drugs but rather some of their plant protocols thst were not up to scratch. It may well be that the Canadian generics are manufactured, if not in packaged form, then in bulk in India. I tried to put the link up but for some reason it does not go to the article.
Essentially it begins

The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India.

The Warning Letters identify the agency's concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy's manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India. Because of the extent and nature of the violations, FDA today issued an Import alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients (API) (the primary therapeutic component of a finished drug product) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.

The problems at these two Ranbaxy plants relate to deficiencies in the company's drug manufacturing process. These actions are proactive measures that the FDA is taking in order to assure that all drugs that reach the American public are manufactured according to cGMP requirements. While this action does not involve removing products from the market, FDA has no evidence to date that Ranbaxy has shipped defective products. We will continue to monitor the situation.

Today's announcement does not impact products from Ranbaxy's otherplants which are not affected by today's actions. FDA has inspected those facilities and, to date, they have met U.S. cGMP requirements for drug manufacturing.

The FDA recommends that consumers continue taking their medications manufactured by Ranbaxyand not disrupt their drug therapy, which could jeopardize their health. Patients who are concerned about their medications should discuss their concerns with their health care professional.

Bill
1/05 PSA----2.9 3/06-----3.2 3/07-------4.1 5/07------3.9 All negative DREs
Aged 59 when diagnosed
Biopsy 6/07
4 of 10 cores positive for Adenocarcinoma-------bummer!
Core 1 <5%, core 2----50%, core 3----60%, core 4----50%
Biopsy Pathologist's comment:
Gleason 4+3=7 (80% grade 4) Stage T2c
Neither extracapsular nor perineural invasion is identified
CT scan and Bone scan show no evidence of metastases
Da Vinci RP Aug 10th 2007
Post-op pathology:
Positive for perineural invasion and 1 small focal extension
Negative at surgical margins, negative node and negative vesicle involvement
Some 4+4=8 identified ........upgraded to Gleason 8
PSA Oct 07 <0.1 undetectable
PSA Jan 08 <0.1 undetectable
PSA April 08 <0.001 undetectable (disregarded due to lab "misreporting")
PSA August 08 <0.001 undetectable (disregarded due to lab "misreporting")
Post-op pathology rechecked by new lab:
Gleason downgraded to 4+3=7
Focal extension comprised of grade 3 cells
PSA September 08 <0.01 (new lab)

Post Edited (BillyMac) : 2/17/2009 7:00:00 PM (GMT-7)

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