ImClone Doc May Rat On Martha Stewart, Accept Jail in Plea Deal

NY Sun ^ | 26 jul 02 | COLIN MINER

[Buffalo Head]

"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.

[solzhenitsyn]

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.

[Don Joe]

"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.

[crusher999]

Martha surely will have a special cooking episode titled, ... "EATING YOUR OWN"...

Nice turn of phrase

[Redhd2]

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"..

[Redhd2]

Very insightful CT. Thanks for your expertise. As usual
right on the money.

[Miss Marple]

FYI

[DeaconRed]

"She is a soldier in the army of the left, and I feel no pity.

Me either

[TruthShallSetYouFree]

Where is that wascally Waksal?

[jwin]

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.

[solzhenitsyn]

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.

[solzhenitsyn]

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.

[fuzzthatwuz]

"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.

[teletech]

She'll also look good in wide pin stripes!

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

[teletech]

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!

[Don Joe]

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.