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ImClone Doc May Rat On Martha Stewart, Accept Jail in Plea Deal
NY Sun ^ | 26 jul 02 | COLIN MINER

Posted on 07/26/2002 6:32:48 PM PDT by white trash redneck

- Federal prosecutors believe Ms. Stewart and Dr. Waksal, close friends who share a stockbroker, also shared information about ImClone, the company Dr. Waksal ran before stepping down and being arrested on insider trading charges.

Prosecutors allege Dr. Waksal told his father and one of his two daughters they should sell stock in the company because the Food and Drug Administration would be announcing they were denying an application by ImClone to proceed with the cancer drug Erbitux.

Prosecutors planned to indict Dr. Waksal last week but changed course at the last minute when Dr. Waksal’s lawyers reportedly said their client was willing to discuss a possible plea bargain.

Sources said Dr. Waksal — who had maintained that he is innocent and any evidence against him is circumstantial at best — made the decision after prosecutors told his daughter, Aliza, they had enough evidence to indict her as well.

The sources added that Dr. Waksal — concerned that his father and other daughter would also face charges — sent a message that he would be willing to plead guilty to insider-trading related crimes if the government was willing not to pursue charges against the other members of his family.

Despite his willingness to discuss cooperation, Dr. Waksal, according to these sources, was concerned that federal sentencing guidelines would require him to spend a minimum of seven years in prison. The only way he could plead guilty and see his sentence reduced would be to offer the government information it could use.

As a result, according to sources familiar with negotiations, Dr. Waksal sent word to investigators that he would tell all he knows.

“He wants to protect his family,” one source familiar with the negotiations said. “He doesn’t want to see them hurt any more.”

Sources cautioned that the talks could fall apart.

But if Dr. Waskal is able to reach a plea agreement it could spell trouble for Ms. Stewart, who has maintained she did nothing wrong.

Prosecutors are particularly interested in what Dr. Waksal can say about the actions of Ms. Stewart, their broker Peter Bacanovic, and his assistant, Douglas Faneuil.

Federal investigators are trying to determine if Ms. Stewart was acting on information provided by Dr. Waksal when she sold her 4,000 shares in ImClone on December 27 — the day before the FDA rejected the Erbitux application.

Prosecutors expect that if Dr. Waksal cooperates, he will explain what Ms. Stewart and Mr. Bacanovic knew about the problems of ImClone and when they knew it.

Prosecutors say they know there was communication be- tween the three that day concerning the stock.

Federal law enforcement sources said prosecutors are trying to determine whether Ms. Stewart obstructed justice or lied to investigators.

Prosecutors believe that Mr. Bacanovic may be the key. And they’re not the only ones.

Congressional investigators yesterday received Mr. Bacanovic’s home and cell phone records.

They previously received his office phone records and trading logs.

A lawyer involved with the investigation said Dr. Waksal’s willingness to cooperate will put pressure on the others to step up to the plate.

“It’s almost like musical chairs,” the lawyer said. “There’s a certain amount of potential defendants all trying to get cooperation agreements. Eventually, the music will stop and someone will be left standing.”

Representatives of Dr. Waksal, Ms. Stewart, Mr. Bacanovic, and Mr. Faneuil had no comment on the negotiations.

A spokesman for the United States Attorney for the Southern District of New York also declined to comment on the talks.


TOPICS: Business/Economy; Crime/Corruption; Culture/Society; Front Page News; News/Current Events
KEYWORDS: imclone; marthastewart
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To: Common Tator
"Nearly 5 years ago I was diagnosed with terminal lung cancer."

I am very pleased that you won that battle. There will be many more battles in the future. We need your cool headed wisdom and ability to write.

21 posted on 07/26/2002 9:00:08 PM PDT by Buffalo Head
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To: Common Tator
With all respect, Common Tator, I don't think the world's leading oncologists consider Erbitux a "fake cancer drug". Leonard Salz and John Mendelson obviously don't. I haven't seen anyone call it a fake, and the FDA certainly has made no such allegation. The FDA rejected the Erbitux application (not the drug), because the it was poorly prepared, poorly documented, and it did not respond to specific direction from the FDA. As Richard Pazdur, an FDA heavy and an expert on colorectal cancer, famously put it during the recent Congressional inquiry, "Good drug, bad application." Sorry, I don't remember Dr. Pazdur's exact title; believe he's the director of the division for oncology drugs. I've seen him touted as a candidate for head of the agency.

Adam Feuerstein, of TheStreet.Com, has been one of Imclone's harshest critics. He said in a column today, "By almost all accounts, Erbitux is a promising cancer drug, but for reasons still unexplained, ImClone executives blew it. Instead of nearing the FDA finish line, the company and its drug are just getting to the starting gate."

http://www.thestreet.com/tech/adamfeuerstein/10010676.html

What Sam Waksal is accused of is insider trading. It's alleged (and sadly, I'm inclined to believe) that he got an early heads-up from a Bristol Myers Squibb executive that Imclone was about to receive a Refusal to File (RTF) letter from the FDA for the Erbitux application. Dr. Pazdur has admitted that he inadvertently leaked word of the RTF letter to the BMS guy. I understand that Dr. Waksal allegedly sold shares of his own before the news was made public, and tipped offed others as well.

Erbitux is not dead. As Adam Feuerstein mentioned in today's article, Imclone is working with the FDA to re-apply for approval. The great significance of the RTF letter is that assuming that the drug is eventually approved (and most seem to expect is will be), Erbitux is expected to be at least a year late to market, and competing products may win approval first. "First to market" is a huge advantage in the drug business, as physicians are reluctant to switch to a new product if they already have experience with one with the same basic mechanism of action that they're comfortable with.

22 posted on 07/26/2002 9:11:47 PM PDT by solzhenitsyn
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To: Common Tator
"No one files not being certain that a the drug will be approved. If it does what is claimed it will be approved."

No one can be that naive.

There is so much corruption at the FDA that it boggles description. For anyone to say the above with a straight face is frightening.

The fact that even major pharmas have drugs rejected right and left on "technicalities" should by itself be all the evidence anyone needs to cut through your "logic".

But I'll wrap up by saying that I'd be interested to see if you extend your polyanna admiration of the ethics of that agency to the ATF, who has quite a track record of nailing "paperwork techicalities" too. I hope that you're at least consistent in your naivete.

23 posted on 07/26/2002 9:50:11 PM PDT by Don Joe
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To: Vidalia
Martha surely will have a special cooking episode titled, ... "EATING YOUR OWN"...

Nice turn of phrase

24 posted on 07/26/2002 10:05:50 PM PDT by crusher999
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To: Vidalia
Martha surely will have a special cooking episode titled, ... "EATING YOUR OWN"...

It may be entitled......"EATING YOUR OWN CROW".... or ...."EATING YOUR OWN HUMBLE PIE"...or even "EATING IN THE BIG HOUSE"..

25 posted on 07/27/2002 4:40:27 AM PDT by Redhd2
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To: Common Tator
Very insightful CT. Thanks for your expertise. As usual
right on the money.
26 posted on 07/27/2002 4:49:37 AM PDT by Redhd2
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To: Dog
FYI
27 posted on 07/27/2002 4:59:57 AM PDT by Miss Marple
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To: Miss Marple
"She is a soldier in the army of the left, and I feel no pity.

Me either

28 posted on 07/27/2002 5:07:10 AM PDT by DeaconRed
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To: white trash redneck

Where is that wascally Waksal?

29 posted on 07/27/2002 5:21:11 AM PDT by TruthShallSetYouFree
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To: Common Tator
I don't believe she is dumb or smart. She is just full of arrogance and acts like royalty which putd her above us common peasants.
30 posted on 07/27/2002 5:30:52 AM PDT by jwin
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To: Common Tator
Erratum:

The Feuerstein article I cited was not hot off the press, it was from back in February. Came across it while doing some fact-checking on Google for the bit I was writing. I misread "2/27/02" as "7/27/02".

By the way, Common Tator, while I respectfully disagree about the apparent merits of Erbitux, I surely appreciate your concern about medical scams. When I was a young enlisted kid in the Navy, I sold 60 days' accumulated leave to buy stock in what turned out to be a medical scam. That still hurts.

31 posted on 07/27/2002 6:26:45 AM PDT by solzhenitsyn
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To: Common Tator; Don Joe
I think the real tragedy is that Imclone's apparent mismanagement of the application process has caused a substantial delay in patients getting the drug. Colorectal cancer kills about 57,000 Americans per year, and the last I heard, there were 10,000 pts. on the waiting list for Erbitux. Erbitux would probably help a fraction of them. It's not a miracle drug, but it appears to be an incremental improvement over existing drugs, which is generally the best you get w/ a new cancer med. At any rate, the delay in getting Erbitux to market is probably costing thousands of lives.

Imclone's defenders say that the FDA's guidance re the application was confusing and changed with time. I wonder if the FDA couldn't have just gone ahead and given the drug conditional approval and required Phase IV (post-approval) studies to address their concerns.

The FDA has been unusually difficult to deal with lately, which is the principal reason Biotech stocks are in the pits. Nearly every "large molecule" drug application in the past year has resulted in the FDA asking for more data, which generally results in about a year's delay, and occasionally, new trials. The FDA has been without a director throughout President Bush's tenure, and everyone there is afraid of making mistakes. Loath as I am to criticize this President, I wish he'd at least make a nomination, because things are badly bogged down at the FDA, and they need someone to get them moving. I've become so impatient that I'd be pleased for just about anyone to get the job, as long as Teddy Kennedy doesn't like him.

32 posted on 07/27/2002 7:07:04 AM PDT by solzhenitsyn
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To: jackbill
"It's a good thing to let off a whole damned corrupt family in a trade for Martha Stewart? I don't think so".

You are absolutely right. No plea negotiations. Let everyone involved swing gently in the wind. We can expect further revelations and investigations into corporate malfeasence as this plays out. These "elitists" will turn on each other in an attempt to save their greedy selves. They must go down before individual investor confidence can be restored to the marketplace.

33 posted on 07/27/2002 7:32:35 AM PDT by fuzzthatwuz
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To: Drango
She'll also look good in wide pin stripes!

I think you meant to say "pen stripes", didn't you?

34 posted on 07/27/2002 9:00:18 AM PDT by teletech
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To: Mad_Tom_Rackham
Of course, it will be tastefully appointed with accessories made from paper plates from the prison cafeteria.

I can see it now.... A whole new line of Martha Stewert prison ware. BWAHAHAHAHA!

35 posted on 07/27/2002 9:04:39 AM PDT by teletech
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To: solzhenitsyn; Common Tator
If you want to talk about colon cancer and FDA scandals, do some research on Cell Pathways (in Horsham PA) and their drug "Aptosyn".

People are dying daily that could be saved by their cheap, safe, effective drug -- a metabolite of a drug that's been on the market for decades -- but, too many Big Pharma bucks would be lost if it was approved.

I'll give you one tidbit: at the FDA ODAC hearing for Celebrex (for FAP label), they had a witness testify about the investigational drug she was given, and how it miraculously saved her life. After she presented her story, the drug was approved.

The ODAC committee was not told, however, that the drug she was talking about was not Celebrex. And she was not told that the ODAC committee was not meeting to discuss the drug she had taken.

What drug had she taken?

Aptosyn.

The word "scandal" doesn't do justice to the sh*t that goes on in that world.
36 posted on 07/27/2002 9:58:54 AM PDT by Don Joe
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