CMC: I’m in agreement with all your points. Frankly, I don’t see how we could function efficiently without them. And, I certainly agree with your point about academic centers. Any loss of key or support personnel during a study can derail deadlines. I’ve also run into quite a few super egos.

I’m not overly negative on CROs, quite the contrary, but I have had my moments.

Chris, sorry I got the different Chris.

I was not sure in that discussion whether CRO was “contract clinical sites” where study is done (treat patients) or more the “administrative coordination” contractors who run trials (supervise, monitor collect data) as I have seen CRO refer to both.

My second hand observations in working/meetings with Clinical groups (CRO type 2 mostly) would generally support your comments on highly variable (drop off) in experience, inconsistent communications and (sucking up) with potential lack of engagement (usually if might rock the boat). However CROs can be an effective/necessary tool, particularly for small companies, but like any contractor (i.e. manufacturing) good ones requires sponsors to provide due diligence up front, clear objectives and expectations, monitoring and adjustments. Unfortunately many sponsors do not exercise these responsibilities (often because they are likewise inexperienced themselves).

The other side of this I have seen is that many of the issues are as bad or worse at academic clinical sites (more like the type 1 CRO) whose agenda seems more geared toward (hesitate to say) getting grants/payments and papers and where GCP appears to be an after thought. Again whether managed via CRO, or directly, the sponsor has to be proactive with all clinical sites with problems. As you suggest should not generalize but if you are going to point at CROs there must be recognition that sponsors and academics suffer similar failings.

CROs cultivate relationships with senior medical and clinical development people in a company and view them as the only client. That means if you want to raise concerns with them or explore data analyses unrelated to the direct purpose of the clinical trial, you tend to be blown off.

One has little control over what a CRO does on a daily basis. The flow of communications is not as consistent or as straighforward as either the contract requires. Getting info can be as difficult as pulling teeth.

Below the level of senior people in CROs you see a big drop off in quality and experience. That’s a rather damning statement to make but that’s my experience and its found across both CROs and consulting firms. In other words a lot of the people running the trials are inexperienced (to be kind) and think they know it all.

Some are better than others so I shouldn’t generalize my experiences to the entire sector.

Well — the thought, I gather, was that these Justices ought know better than anyone that the whole world watches their rulings — and they, as “the best of the best”, would be self-limiting on conflicts of interest. And I think that has proved generally true. But there are no rules to cite, as to SCOTUS recusals.

Now, on the Medtronic stock charting — first, Medtronic stick has had many problems of its own (confusing variables), but more importantly, I think most people viewed that case as Act II in a Four Act Play. The smart money knew the fat lady hadn’t cleared her throat yet. So, one can’t read too much into that one stock-pricing.

If, on the other hand, the Justices sweep aside damages for all drugs — I think we will see a reall effect. Though note that Rep. Waxman is already busily drafting legislation to nullify the result in the Medtronic case.

For what it is worth. . . .

Again, there are a lot of variables. It would be good to know relevant precedents and decision-rules on recusal, which were my own questions.

But just for curiosity, I checked in to see what happened with Medtronic stock before and after the Riegel decision. The chart I got was rather crude, and I didn’t dig for all the exact dates, but it looks like there was a significant sell-off in September - _possibly_ coinciding with when Court decided to hear case (but I don’t recall that). Stock abruptly dropped ten points or so.

Since then, it’s been up and down, but not much overall variation. Thus, still roughly where it was after drop-off.

So, as I read tea leaves, it _looks_ to me (all disclaimers apply) that the potential cost of a negative Court decision made more difference (perhaps via institutional dumps) than the benefits of a positive one - at least so far.

Thus, if one were looking closely at Justice COIs, the relevant moment might be when cert. is granted (case will be heard) rather than when/how it is decided.

Note also that Riegel was brought by Riegel _against_ Medtronic. The other major preemption cases - Kent, Levine, etc. - have been brought by company in the attempt to reverese lower court decisions in favor of plaintiffs. That would make a difference too.

Maybe I should open up a sideline….Moolah in Michigan

Justice,
I wasn’t assuming that you are a financial guru — I just figured that you had thought about it because it does have some significant implications to this conflict-of-interest issue. If the stock price wouldn’t change much based on the ruling, then there really isn’t much of a conflict of interest regardless of how much stock any of the justices own.

I know there was “talk” by some in Congress - particularly Kennedy, Pallone, and Waxman - about amending the MDA so that the impact of the Riegel v. Medtronic decision would be modulated. But my impression is that not much has happened. (Waxman’s hearing tomorrow is, of course, related.) Do you know if a bill has actually been introduced? And, if so, its number?

Re: Riegel, yes, Breyer did not recuse. Interesting example.

To Nathan’s question - Wow, no one has asked me about stock prices before, and my wife would suggest I’m not the one to go by! So the truth is I have no idea. Perhaps one could extrapolate from whatever happened with device company share price following Riegel (I have no idea of that either). My _guess_ is that whatever bump, if any, would be very small. There are too many other factors.

Also, it depends on how the cases are decided. There are scenarios in which Wyeth v. Levine could be decided fairly narrowly, and thus might not have the impact on the “big question” of preemption that most anticipate it will have.

Maybe this is a good question for Cramer? A big preemption Boo-ya.

I guess you and I will differ rather markedly on this point.

The imagined math (yours: 5% to 10%) seems to be lacking some real-world examples:

So, imagine, if you will, that Merck had NEVER faced liability for, say, a Vioxx fall-out. Add $4.2 billion in settlement proceeds back to 2008 NET-income; AND add back perhaps $700 million in “all-in” legal fees, expert witnesses, jury consultants, opinion studies, mediations, and post-event FDA submissions. . . . ALL of it falls directly to the NET INCOME line — deduct taxes, and it becomes whole dollars of NEW EPS!

Even for Merck, that would “move the needle”, and move it QUITE A BIT — that is one drug; one event; one year.

Consider the Prozac cases.

Consider (on implantable device side, now) mammary implant litigation — again, $4.1 billion global settlement funds — returned to Dow-Corning’s bottom line in 2008. And, perhaps, another billion in fees, etc. — or almost $5 billion — it would likely not have been placed in receivership.

THOSE are the stakes — and I submit to you, that (at least as to Justice Breyer’s holdings — see below) these sorts of increased profitablity — in perpetuity, now! — will make a BIG difference.

An onlder version of this would be the old blood-products-chield laws — which prevented suits against blood products producers. Look at how much that business has declined, since the appearance of Swiss-Cheese-like holes throughout that doctrine. . . . effectively dissolving the blood products “shields”.

Finally — and of lesser import, here, but worthy of note, nonetheless — Justice Breyer’s interests look to be well-north of $300,000, or 6 to 30 times the amounts you’ve originally suggested. See his actual 2006 Form on my site — PDF.