Shhh! Baxter, Confidentiality & Public Health
9 CommentsBy Ed Silverman // March 10th, 2008 // 12:27 pm
Amid the ongoing scandal over contaminated Heparin came an interesting admission last week. You may recall the FDA failed to inspect a Chinese plant that supplied the key ingredient to Baxter International, which has recalled its supplies of Heparin, a blood thinner that was linked to hundreds of serious adverse events and 19 deaths.
The FDA has since inspected the plant and found numerous problems. As it turns out, Baxter conducted its own inspection of the China plant last fall, The New York Times reported. “A few of our observations touched on the same areas as FDA inspectional findings,” Ray Godlewski, vp for quality at Baxter’s medication delivery business, told the paper. But he refused to be more specific because of a confidentiality agreement with Scientific Protein, the Times wrote.
We understand issues of confidentiality and liability, but given the growing public health concerns, we found this to be curious reasoning. We’ve asked Baxter to explain, but so far, no reply. UPDATE: A Baxter spokeswoman wrote us to say that “it’s not unusual that two different audits many months apart would have different findings,” and that a few observations “touched on the same areas as FDA’s inspection findings. Based on the data currently available, it does not appear that those observations could be related to the root cause of the allergic reactions.” She did not provide details about the findings, how or why these may have differered, or an explanation for the lag time in disclosing the information.
Prior to her response, we asked Art Caplan, who heads the Center for BioEthics at the University of Pennsylvania, his thoughts on whether it was appropriate for Baxter to maintain confidentiality since its inspection. Here’s what he had to say…
Pharmalot: So you saw the comment from the Baxter exec about confidentality. What’s your reaction?
Caplan: Confidentiality is important, but sometimes has to yield when there’s a clear and present danger to public health and requires some corporate judgement about when to yield in the face of that threat. And this looks like a pretty clear case to me.
Pharmalot: Okay, but they do have a legal agreement that can be enforced. Why isn’t that a legitimate consideration?
Caplan: To say I have an obligation not to disclose sensitive information or the right to intellectual property, to use another example, doesn’t mean for all times and all places. Sometimes, organizations just wrap themselves on a lofty moral stance, but that’s just using ethics to protect you from the problem. It’s rare that you can think of a right or privilege that can’t be trumped. Confidentiality is a privilege, yes, but it’s not beyond trumping other, more important principles.
It’s similar to when a psychologist or mental health worker has a duty to warn. If I say in a therapy session that I’m going to kill someone, does the psychologist have to call you and tell you, or anyone? Yes, they do. If I plan to do harm, they have an obligation to break confidentiality and warn.
Pharmalot: But there’s a difference between a psychologist and a corporation and their obligations, isn’t there?
Caplan: The moral case is the same. Let’s say you have a product - a contaminated or tampered product - and it’s going to people and could really do harm. Sometimes, you have to override confidentiality when there’s a clear and present danger from your products. You need to warn. That’s corporate ethics. Hiding behind a confidentiality agreement, seems to me, at best disingenuous. And at worst, it’s cruelly indifferent. If you make a defective defribillator or you have a drug that’s been tampered with, you have to get on it and start warning. Don’t tell me about your confidentiality agreements.
Harry Lewis
Dr. Caplan’s analogy to the psychologist’s duty to warn of imminent danger does not make sense in this situation because Baxter has already recalled the product and, thus, has warned all impacted parties not to use heparin. While there may be other arguments to be made as to why disclosure might be appropriate, his assertions miss the mark.
Ed Silverman
Hi Harry,
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
Harry Lewis
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.
Ed Silverman
Hi Harry,
Understood. And I’ve fixed the intro to make that clearer. Apologies for any confusion.
ed
CMC guy
I agree with Harry that the slant here can be easily misinterpreted and without further details it smacks of 20/20 Hindsight. Would any of the observations of FDA or Baxter have prevented what happened? Did Baxter/supplier develop an action plan to address the problems that would have prevented and slow in implementing? Maybe in time we will be able to answer yet everything currently appears more speculative than concrete in knowing the cause and more so hows and whys. Trust that the investigations will work to determine solid answers and appropriate lessons learned even after the media and blogging frenzy cools.
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.
Ed Silverman
Hi CMC Guy,
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
Pat
To all of you/any of you:
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
911doc
pat,
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.
bob bertino
who would be responable about the hepperin tainted medicine