Here come the lawsuits

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Postby OddDuck » Thu Mar 10, 2005 5:44 am

http://www.reuters.com/newsArticle.jhtm ... ID=7857472

...."Obviously the SEC and the company are going to go back and closely scrutinize stock sales leading up to such a disclosure," said Geoff Porges, an analyst with Sanford Bernstein.

"Clearly this guy did something very dumb. You would have thought a general counsel would know better," added Porges.

The Cambridge, Massachusetts-based company declined to comment on the resignation or offer any reason for Bucknum's sudden departure.

A Biogen spokesman at the time the stock sale was revealed said that Bucknum had no knowledge of the safety concerns with Tysabri when he sold his shares. ....


Yes, I'd say he DID know better. Pardon me, but that's hard to swallow (i.e. that he had "no knowledge"). And does any of this really come as a surprise to us?

From various November postings of mine here on thisisms:

....But then again, man..............how in the world can you weed out all of the overwhelming probable "influence" ploys (marketing, investor relations, etc.) that is being spread around right now, as opposed to the actual clinical efficacy?...

Still................how much of these built-up "reveal" strategies are to influence stock prices? ...

This almost feels like an "all or nothing" move on their part. Either they are thinking of a quick "strike and make it rich" short-term viewpoint, or they have something else up their sleeve. Is Antegren just a "take off" point? Man.........still.........risky business they are up to.....

I could be wrong, but I've seen this "quick strike" tactic used before. In order to infuse funds quickly. ...

Getting interesting, huh? As far as from a patient's viewpoint? There is way too much business maneuvering behind the scenes in connection with Antegren for it to feel real "secure" to me. ...

EDIT: Oh, yea, and their big-wigs have been moving around stock like crazy. That much inside stock activity doesn't bode well. Whenever you see that, you can bet there's a hidden agenda going on. Check out the amount of SEC form 4 filings they've been doing lately. ...

...Get this - from the management team of Biogen Idec:

"Thomas J. Bucknum, Esq., Executive Vice President and General Counsel

Thomas J. Bucknum was previously Executive Vice President and General Counsel at Biogen. He joined Biogen in 1996 as Chief Corporate Counsel and was appointed Vice President and General Counsel in 1999. Previously, he was Senior Vice President and General Counsel for DuPont Merck Pharmaceutical Company from 1990-95, responsible for Legal, Government and Public Affairs. Mr. Bucknum held a number of positions with E.I. DuPont de Nemours and Company, including Director of Regulatory Affairs and Quality Assurance for Medical Products; Marketing Director for Agricultural Products, Europe, Middle East and Africa; European Counsel; and Patent Counsel for Pharmaceuticals and Agricultural Products. He holds a B.S. in Pharmacy, an M.S. in Pharmacology, and a J.D. from Temple University."

Small world, isn't it? I have no comment, of course.


...Ok...........regarding VLA-4 antagonists. Are they an interesting and potentially highly beneficial find? Absolutely. But, is playing around with VCAM-1 and VLA-4 fairly complex? Absolutely.

Originally, (and HARRY and ROBIN, you're going to find this sort of interesting), our friends at Merck have been looking into VLA-4 antagonists - for quite a while. (Remember our person who migrated from Merck to Biogen? No insinuations there, but can't help but notice the coincidence.) Anyway, we all know that Merck is a fairly gutsy risk taker when it comes to manufacturing pharmaceuticals (i.e. Vioxx). Well, even they slowed down and backed off just a bit on VLA-4 antagonists. That "may" or "may not" say a thing, though. You decide. ....


Given all of the above, no...........personally I don't think Bucknum was "dumb" at all. He knew..........I would speculate that he knew everything. (That is just my personal opinion, of course, based on what little information I have.)

Deb

EDIT: And why would he be the first to resign? My guess? Because he's the one most likely to have criminal charges brought against him, at least at first. But, again, that is just speculation on my part.
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Re: Biogen Idec Announces Management Change

Postby HarryZ » Thu Mar 10, 2005 7:02 am

Better,

Your information is correct:


Isn't it usually? :D :D

Take care.

Harry
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Postby OddDuck » Thu Mar 10, 2005 8:16 am

Hi, Harry!

You know what? My gut tells me there is still a big piece of the puzzle missing here.

I wonder............was Biogen in any merger talks with a bigger pharma?

If so, due to confidentiality agreements between two corporations during "negotiations", nothing would have been published about it anywhere nor would the SEC necessarily have been really notified yet.

Deb
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"Like most MS drugs............"

Postby SlowI » Thu Mar 10, 2005 9:21 pm

Wow Flora,
What a catch on that original post. Your comment made me pull out the folded fine print that comes with my Avonex injections to see if PML is mentioned anywhere.
I couldn't find it mentioned, but maybe someone else with a longer attention span might see it. I have to say, I was encouraged when I DIDN'T see it mentioned, but that's probably false hope based on the notion that for someone to make this statement MUST have more information that we have.

I'd love to hear more about the "Like most MS drugs" part.

Thanks,

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Postby Arron » Thu Mar 10, 2005 10:19 pm

IMO the "like other MS drugs" comment is an ill-informed, sensationalist comment made to lure in members of the class (investors), who likely have little clue what the other meds even are, not to mention their side effect profile. Don't pay heed to it as PML has never been commonly associated with MS therapies.
Disclaimer: Any information you find on this site should not be considered medical advice. All decisions should be made with the consent of your doctor, otherwise you are at your own risk.
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Postby Ptwo » Fri Mar 11, 2005 4:16 am

Biogen took 11 days to act on MS drug warning
By Richard Irving



SENIOR executives at Biogen Idec are to face fresh questions over share dealings and bonus awards after a senior doctor working on a crucial trial of Tysabri warned the drug developer that a patient had suffered adverse side-effects as early as February 7.
Daniel Pelletier, who was running the trial among 24 patients at the University of California, San Francisco, notified Biogen that a patient had been admitted to hospital 11 days before the company notified US regulators of a potential problem and 20 days before tests on the multiple sclerosis treatment were halted.



The disclosure will be of interest to the US Securities and Exchange Commission, the stock market regulator that is understood to be looking into the timetable of events surrounding the company’s share price collapse. Biogen shares fell 43 per cent on February 28 after the firm said the drug might be linked to a rare but often-fatal brain disease.

Biogen executives first notified the US Food and Drug Administration of potential problems with Tysabri on February 18. The same day Thomas Bucknum, Biogen’s general counsel, exercised stock options and sold 89,700 shares, netting $1.9 million (£990,000) in profits. The lawyer abruptly resigned from Biogen on Tuesday night without severance pay. Mr Bucknum denies any wrongdoing.

During February 14 and 15 a number of other senior Biogen executives including William Rastetter, the executive chairman, Robert Pangia, a director, and Craig Schneier, executive vice-president for human resources, also sold shares.

A Biogen spokesman insisted yesterday that all three transactions were in line with company policy. He declined to comment on Mr Bucknum’s dealings. On February 17 the company’s senior executives were granted $4.6 million in bonuses.
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Postby OddDuck » Fri Mar 11, 2005 5:18 am

Arron,

I'm not trying to argue about semantics here, but in law, you have to read every single word EXACTLY.

What they say in the Complaint is:

that TYSABRI, like other MS drugs, made patients susceptible to progressive multifocal leukoencephalopathy ("PML")...


The way you are interpreting that statement is that it says "causes" PML.

No, that is not what they are saying. Any MS drug (just exactly like Novantrone, as I showed everybody specifically) that increases the "risk of infection" in any manner, shape or form, thereby makes patients "susceptible" to PML. PML is an "infection". It's just a part of "critical thinking". The "if, then" philosophy. It's even used in math.

For instance "IF other MS drugs make patients susceptible to infection (they do, it's written in their enclosed pamphlets, but remember it doesn't say "all" other MS drugs), and IF it was known that Tysabri could contribute to an increase in infection [which even Biogen told people, they just didn't specify WHICH infection(s) - whether they were known or unknown at the time - and lo and behold an infection DID arise, plus there is plenty of research that proves same], and IF PML is an infection, THEN Tysabri, like other MS drugs, made patients susceptible to PML. They teach that method now in high school. No wait, in middle school. My eighth grader was just recently learning it. Therefore, that above would be a true statement in and of itself. You see? In law, you cannot put more "meaning" nor can you put ANY "emotion" into any statement, etc. than is there. Every single word in a sentence has to be read and interpreted as was intended and according to its actual definition. EVERY word.

Now, if the sentence had said ..."that Tysabri, like other MS drugs, caused PML...." your objection would be valid. Otherwise, it is not.

I realize it sounds silly, but truly, to be good in law, you MUST be very detailed and your statements and/or allegations must be worded extremely specifically.

Trust me, they could even be sanctioned in court, if they could not provide any supporting substantive evidence for everything that is put in a Complaint. In law, you cannot get away with saying the same things you can get away with saying in the press (and even then, what you say to the press can come back to haunt you). Not if you don't want to risk not only the court's time for non-meritorious allegations (and possible sanctions), but your own legal reputation and possibly eventually, your very bar license itself.

Any chemotherapy drug, which a couple of other ones are also being tried and used off-label by some neurologists, due to immunosuppression, has the risk of infection connected with it. That is nothing that everyone doesn't know (or should). So, will that particular allegation be easy to prove? Yes. I just did it myself above, Arron. That's all that would basically be required to show the truth of that statement. I just showed it to you myself. Add to that all the research and expert witnesses they can call in to testify that drugs that suppress the immune system run the high risk of infection, and it's a done deal. It's common knowledge in medicine.

Remember, folks, when you are reading a legal document as opposed to a press release, an attorney doesn't just write any old thing off the top of his head. It is a very "detailed" career. If you do not have an eye for extreme minute detail, you would never make it in law or in front of a Judge. :wink:

Deb

EDIT: Think of it this way. When drafting any court pleading, an attorney has to know how to separate his emotions TOTALLY from it. That's how and why attorneys can represent criminals, whom they even KNOW are guilty. You can't be a lawyer (or even work in law very effectively) if you cannot separate your emotions from your work and be able to totally turn your emotions completely off at times. You have to. If you can't do that, you won't make it as an attorney. There are times when those of us in law, behave and sound like robots. And any "emotion" that you see in court coming from an attorney has been totally "strategized". I realize it makes those of us in the legal profession sound like robots, but well.............sometimes we are.

SECOND EDIT: Oops, I need to clarify myself here. Above when I said "which even Biogen told people", I meant that they told people via their previous published research on VLA-4 antagonists, NOT in their press releases.
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Postby Arron » Fri Mar 11, 2005 12:24 pm

Deb, your points are of course well taken, (and I neither appreciate nor see the need for your insinuation that I don't understand middle school logic; I have multiple advanced degrees in the sciences and understand FOL quite well, thank you) but I think you very well know that that sentence, and in fact this whole press release, was purposely crafted to catch people's attention in a particular manner, and make them jump to a particular conclusion. Don't believe me? How's this sentence:

thereby allowing PML, a normally dormant virus, to run rampant within the human body;


That's not emotional? "run rampant within the human body"?!? Is "rampant" a common term whose use is necessitated in this legal brief? And if we're mincing words here, technically, the virus did not run rampant throughout the body, it went from the kidneys to the CNS (stop rolling your eyes!-- e.g., The legs were not affected! ;) ) In any case, they could just have easily used the equally effective, yet not as visceral "activates" or "proliferate" e.g., "thereby allowing PML, a normally dormant virus, to proliferate," and not have frightened the heck out of people. IMO "running rampant" is a hackneyed, scare-mongering phrase used to describe murderous criminals or rioters ( = scary). Is it technically wrong? No. Is it critical to get the point across? No. Using their logic ON THIS ONE POINT, you could say that Tylenol, which I believe is a mild immunosuppresant (someone check me?) increases the risk of PML.

They have a mission with this PR, and that is to get people motivated to join the class. I'm not saying that the word-for-word meaning is technically incorrect, but the implied meaning to a non-legal reader is very clear, in my opinion, and it leads to the incorrect assumption that other MS drugs make one a candidate for PML (not a single case ever seen to my knowledge with the CRABs or Novantrone).

I have no argument with you that the case has legal merit, I absolutely agree that the ethics/scientific people behind the trial who decided that it would be OK to put together two immunomodulating drugs (one experimental) AND allow the use of a third (steroids) should have their heads examined (and cross-examined, eh?). I'm just making sure people are aware of the motivations behind this filing (money money money!!! This is for the investors-- NOT the patients!) and don't fall trap to the sensationalist PR/advertising tactics used therein.



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Postby OddDuck » Fri Mar 11, 2005 12:49 pm

Arron,

and I neither appreciate nor see the need for your insinuation that I don't understand middle school logic; I have multiple advanced degrees in the sciences and understand FOL quite well, thank you)


Well, I'm sorry you read way too much into that. That wasn't what I was doing at all. I wasn't attempting to imply or insinuate anything of the sort! Again, don't put any emotion into my words that just isn't there nor was ever intended to be there in the first place.

Also, those words came directly out of a legal pleading that has already been filed with the Federal Court, it is not "PR" or "advertising" whatsoever. It is simply what has been filed in a legal pleading with the court.

Whether or not people join the class action is irrelevant. They already have a Plaintiff. It is just more convenient to combine the cases into one, is all. There are five different law firms (I believe it is five so far - you can double-check that with the Stanford Securities Class Action Clearinghouse website that we use to keep track of things such as this). I believe it is at: http://securities.stanford.edu/

Truly, Arron, please don't get upset or offended. And please don't put any "tone" in my words than was intended. I am speaking totally calmly and slowly, in something similar to that of the "teaching" tone I use when I teach.

Sorry if you took it wrong. Remember, my emotions were not a part of that prior post at all.

Deb

EDIT: If you re-read that statement more carefully, you might see another perspective. My intent for saying that was purely to relay information. It wasn't until I was OUT of high school that I was taught anything about critical thinking, etc., so it was simply a statement that they NOW teach critical thinking very early. That's it.

Oh, and yes......the term "running rampant" is an intellectual term that the medical profession itself uses. Again, it truly is NOT a term used in order to elicit emotion. It is just common terminology.

SECOND EDIT:
This is for the investors-- NOT the patients!)


Again, I ask that we agree to disagree. If medical corporations are held accountable for their actions in THEIR pursuit and attempts to make money (at the expense of the patients), no matter how they are held accountable, they might be less likely to be so careless in the future, thereby benefiting patients greatly.
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Postby HarryZ » Fri Mar 11, 2005 2:37 pm

Arron,

I'm just making sure people are aware of the motivations behind this filing (money money money!!! This is for the investors-- NOT the patients!) and don't fall trap to the sensationalist PR/advertising tactics used therein.



I'm not taking sides here and see the varied points of view that are being expressed. But the above quote could just as easily be placed next to Biogen's name in how they marketed Tysabri. Now this same tactic is being used against them and it indeed is all about the money!!

Harry
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Postby OddDuck » Fri Mar 11, 2005 2:43 pm

Touche, Harry! :wink:

What is the saying? "Money is the root of all evil" :?:

Deb
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delayed releasing news until options cashed in?

Postby batpere » Sun Mar 13, 2005 5:24 am

OddDuck wrote:What is the saying? "Money is the root of all evil" ?


Trading in options for Biogen Idec stock spiked on Feb. 9, two days after a doctor reportedly informed company officials that a patient taking Tysabri had developed an unexpected complication.

<shortened url>

Hopefully nobody else developed PML because of the delay.
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Biogen Idec probe grows

Postby better2gether » Wed Mar 23, 2005 5:56 am

.
Milken ex-exec trades set off alarms: Biogen Idec probe grows

By Brett Arends and John Strahinich

Wednesday, March 23, 2005 -

Federal investigators have widened their probe into stock sales at Biogen Idec to include outside director Robert Pangia, sources told the Herald.
Pangia cashed in $1.4 million worth of stock options last month, just days before the Cambridge biotech notified the Food and Drug Administration of problems with its blockbuster multiple sclerosis drug, Tysabri.

Pangia made the trade Feb. 14. That was just four days before Biogen concluded there was a problem with Tysabri and told the FDA. But it was seven days after the company was alerted there might be a problem.
The Securities and Exchange Commission wants to know: What did he know, and when did he know it?

Investigators are already shining the lamp on Thomas Bucknum, the company's former general counsel, who dumped stock for a $1.9 million profit on Feb. 18, the day Biogen warned the FDA of a problem.
Bucknum has since left the company, without getting severance, and hired former SEC Boston boss Juan Marcelino to represent him. He denies any wrongdoing.

There is at the moment no reason to conclude Pangia is guilty of any malfeasance. But Pangia's trade did not follow earlier notification, stripping him of the first line of legal defense.
Two other executives, including Chairman Bill Rastetter, also sold stock that week, but they had put the trades in the pipeline a long time in advance.

Pangia, who is also a partner at financial firm Ivy Capital, could not be reached last night for comment.
Pangia has an intriguing past that has attracted the eye of investigators. His 20-year career as an investment banker included two years at junk bond shop Drexel Burnham Lambert in 1986-87.

Remember Drexel?
Think Michael Milken. He was Drexel's ``junk bond king,'' later sent to prison for stock manipulation and other crimes.
Pangia was Drexel's managing director of investment banking when Milken was riding high.

``It doesn't mean he's guilty of anything,'' stressed one source familiar with the investigation into Biogen. ``There were plenty of good people at Drexel, even then. But it's interesting, isn't it?''

Biogen Idec stock has collapsed to just $38.10 from $67 since the company revealed the problems with Tysabri. Two patients developed a rare condition, and one has since died. The drug, which analysts expected to achieve $3 billion in annual sales, has been pulled from the market pending further study.

Executives and directors made $32 million cashing in stock and options over the months when the going was good. The sales, which were perfectly legal, were made between August last year and last month. During that time the stock price was usually over $65 as investors anticipated success from Tysabri's launch.

http://business.bostonherald.com/busine ... leid=74666
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Thanks

Postby tysabriuser » Mon Jul 25, 2005 11:06 am

Thanks
Last edited by tysabriuser on Thu Aug 04, 2005 6:14 am, edited 2 times in total.
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Postby Arron » Mon Jul 25, 2005 11:30 am

Dear TysabriUser... without sharing more information as to your interests in contacting Tysabri patients, I am not comfortable letting your post stand. The fact that you posted the exact same message on four different threads, and that your e-mail address has -law- in it makes me think you are merely trolling for lawsuits. If so, make your intentions clear and do not use monikers that insinuate you yourself are a Tysabri patient. You and your views are welcome to our community, but if my hunch is correct, please have enough respect for us not to use our community to gather business.
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