i too am curious as to the ‘contaminant’ in the heparin, but let me point out that there are orders of magnitude of difference in the amount of heparin in a flush (used to keep the IV line itself (about 4m piece of plastic or longer if indwelling) and the ‘drips’ we often use to treat cardiac patients or patients with blood clots. your interest in the ‘contaminant’ reaches the level of superstition.

secondly, i must take issue with your stand on immunizations as it is inconsistent with your initial inquiry. let me explain…

if you are concerned with what western medicine determines about a contaminant in a very western medicine (heparin) then why are you so concerned with immunizations?

i am truly sorry that you have an autistic daughter but goodness gracious, if, as i assume, you are referring to a reputed link between immunizations and autism then the cat’s already out of the bag with your daughter and all you are doing by failing to immunize her is putting her at risk for measles, mumps,polio, rubella, tetanus, varicella, hepatitis, flu and other diseases that, at best, would make her very ill, and at worst could kill her and any other non-immunized children with which she comes in contact.

i will believe the immunization and autism link one day, perhaps, when studies with enough statistical power are produced. however, i can assure you, if enough parents think as you do, that the ‘herd immunity’ of other immunized children, will act as a safety for your child, then there will come a time, when enough children go un-immunized, when we will once again deal with the ravages of polio and send folks into adulthood, if they survive, with an antalgic gait and handicaps that they never needed to have. you are sadly mistaken on this issue.

Disclosure and timing aside, gentlemen. What I want to know is what is the contaminant they found. My 9 year old has been treated for a brain tumor since she was 3. She’s had so many hepperin ‘flushes’, I couldn’t even beging to count. I want to know what the unknown ‘contaminant’ was.

I also have a 6 year old autistic daughter. Don’t worry, I’m not going to buff immunizations…..she didn’t/ won’t have any. However, at a large conference on autism, a very well know speaker mentioned (in disgust) that she learned that hepperin, some of the were grown or contained ‘pig guts’. At the time I rolled my eyes…..now I’m trying to reach her…..any comments….answers?
Thank you

You raise valid questions, although I would like to emphasize that there was no attempt to offer a slant, one way or the other. If the problem is a lack of information in which to judge the situation, the responsibility lies with the manufacturer. In Caplan’s view - and this is the view of one ethicist - the legal considerations you raised should take a back seat. That’s why I asked the question about contracts.

I don’t know whether any disclosures, had they been made earlier, would have prevented any adverse events. As you note, an investigation will hopefully ferret that out. But in the context of ethical behavior, Caplan is saying it should have been done sooner, if I understand him correctly. In any event, you see his response.

Thanks for stopping by,

ed

Confidentiality Agreements and Audits are key components of supplier relationships and direct Public disclosures risks lawsuits and/or a reputation for contact breech so could end up no vendors will deal with you. There are always clauses that override secrecy in dangerous situation however notification is direct to reg agencies first. The intention of Audits is to ID problems, and then (hopefully) fix them. Are pharma suppliers to become like celebs being chased by paparazzi where even normal activity can be portrayed negatively? Hard enough doing business as a contractor although both they and the sponsor do have inherent obligations in aim to heal and not harm end users.

Understood. And I’ve fixed the intro to make that clearer. Apologies for any confusion.

ed

I understand your point, but would submit that it was not clear from your Pharmalot posting that Caplan’s comments related to any delay in disclosure from the time of the Baxter audit. If you re-read the posting, it could be interpreted that his comments relate to Baxter’s current maintenance of confidentiality as opposed to what their duty may have been between the time they became aware of quality issues at the China plant and the announcement of the recall.

Caplan was referring to the fact that the Baxter inspection took place last fall, and so the company should have disclosed information at that time any issues or problems with the plant. Since then, of course, Baxter recalled Heparin.

Regards
ed