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.