Prions in hcg

[nuclear]

There are a couple of studies that have identified the presence of prion proteins in urinary derived hcg. I'd like to know your thoughts on the risks of using uHCG. Links are below.

Detection of prion protein in urine-derived injectable fertility products by a targeted proteomic approach - PubMed

JRM Featrue Article

 

[Nelson Vergel]

Shaun Noorian will be answering your question since he is our compounding expert

 

[Gene Devine]

This concern came up some time ago on another forum I moderated; it's not a threat in legally compounded HCG here in the USA.

 

[nuclear]

This concern came up some time ago on another forum I moderated; it's not a threat in legally compounded HCG here in the USA.

I spoke with a manufacturer and they told me that they source the urine via a sourcing company that does their best to screen the patients. They also assured purification processes are followed as per their NDA. They can offer no guarantees that the product is prion free. I imagine the risk is low. At least, I hope so.

 

[EmpowerPharmacy]

We've been dispensing hCG for years and have never been asked this question or come across any papers or data about prions in hCG. Every prescription medication in the US has to be sourced from FDA Registered sources. That means that unless the FDA has visited a facility and approved it using its cGMP (current Good Manufacturing Practices) standards then it is not allowed to manufacture or distribute active ingredients that will ultimately be used in the US market.

HCG, being an FDA approved and monographed drug, has to meet certain standards to be accepted for use in the US. That means that the manufacturer of the hCG has to run tests on the chemical to verify it meets a high standard of quality in order for that chemical to be introduced into the US. For hCG these tests, which are shown on its Certificate of Analysis, include verification of solubility, endotoxin levels, potency, water content, transmissivity, estrogenic activity, HBV DNA, HCV RNA, and HIV RNA. Unless the chemical passes all of these specifications then it cannot be used in drug products destined for the US. Nowhere on hCG's monograph does it ask for testing of prions.

Nuclear is correct in that in order to be granted NDA (New Drug Application) through the FDA the manufacturing facility has to be FDA Registered and meet the standards required for that drug's monograph. Not only do the chemical's sources have to been of the highest grade, but the manufacturing process has to be as well. Currently, under USP (United States Pharmacopoeia) and EP (European Pharmacopoeia) standards testing for prions is not a requirement for hCG.

 

[tomas]

Sorry to bring up this old topic but I was doing a bit of research on Prions and came upon the thread.
Prion transmission in blood and urine: what are the implications for recombinant and urinary-derived gonadotrophins?
DEFINE_ME

Total cases of iatrogenic CJD world-wide



n

[TH="bgcolor: #F2F5F9, align: left"]Mode[/TH] [TH="bgcolor: #F2F5F9, align: left"]Cases (	)[/TH] [TH="bgcolor: #F2F5F9, align: left"]Mean incubation period (years)[/TH] [TH="bgcolor: #F2F5F9, align: left"]Clinical[/TH]
Neurosurgery	4	1.6	Visual/cerebellar/dementia
Depth electrodes	2	1.5	Dementia
Corneal transplant	3	15.5a	Dementia
Dura mater	136	6b	Visual/cerebellar/dementia
Human growth hormone	162	12b	Cerebellar
Human gonadotrophin	5	13	Cerebellar

Acquired prion disease: iatrogenic CJD, variant CJD, kuru

In the case of HGH
Since 1985, urea-treated cadaveric hGH or recombinant hGH produced in Escherichia coli has been used in place of native pituitary-derived hGH. With urea-treated or recombinant hGH, no cases of iCJD have been identified. iCJD cases begin with a cerebellar syndrome without signs of dementia.