And the FDA does not have a big enough budget to monitor post marketing problems with approved meds.

Curious how you arrived at this...what is their budget, and how is it distributed?

Ex Biogen exec fined $3 million dollars to settle insider trading charges

http://www1.cchwallstreet.com/ws-por...sp?fn=01-17-06

Ex-Biogen Exec Fined $3M in Insider Trading Case By Jennifer McCandless
January 17, 2006

Thomas Bucknum, former general counsel for Biogen Idec, will pay $3 million to settle insider trading charges filed by the Securities and Exchange Commission.

According to the SEC, Bucknum sold thousands of company shares in the two weeks before the company’s multiple sclerosis drug, Tysabri, was withdrawn from the market in February 2005 because of safety concerns.

In settling with the SEC, Bucknum agreed to disgorge $1.9 million in stock gains from the trade, as well as a civil penalty of $969,000 and interest of $102,000. Bucknum is also barred from serving as an officer or director of a publicly traded company for five years.

Bucknum sold 89,700 shares before information became public that two patients taking its multiple sclerosis drug Tysabri had developed a rare brain disease. Once the information was released and the drug was pulled from the market, Biogen’s stock plunged 42%, according to the complaint released by the SEC.

On the morning of Feb. 18, 2005, Bucknum told his broker he wanted to exercise 89,700 stock options and sell the shares. At about noon, Bucknum attended a meeting in which he and other senior Biogen officers learned that a patient taking Tysabri had been diagnosed with a rare and fatal brain disease and that another patient may have contracted the illness.

Following the meeting, Bucknum called his broker's associate, who told him he had received legal clearance from Biogen for the stock sale, and Mr. Bucknum told the associate to sell the shares. Shortly after 2 p.m., the 87,900 shares were sold for an average price of $67.12 and a profit of $1.9 million.

On February 28, Biogen and Elan Corp., the company’s partner in marketing the drug, suspended Tysabri sales and Biogen’s stock price dropped to $38.65 from $67.28 the day before.

Bucknum resigned as general counsel of the Cambridge-based drug maker last March. In settling with the SEC, Bucknum neither admitted nor denied any wrongdoing.

FDA to create board to monitor drug safety
By Diedtra Henderson, Globe Staff |
February 16, 2005

ROCKVILLE, Md. -- The Food and Drug Administration said yesterday it will create an independent drug safety board -- as critics have demanded -- that would quickly direct the agency how to respond to drugs on the market that are suspected to be unsafe.

The board reflects a major shift in the FDA's approach. To date, most of the agency's focus has been on testing a drug's effectiveness and safety prior to its approval. But once a drug was on the market, the agency relied primarily on the drug industry to alert it to problems. Now the agency is pledging to look for safety problems on its own.

The new safety panel would be made up of agency experts who were not involved in approving the drug and other scientists inside and outside of government. While the drug would remain on the market during deliberations, the panel could act within days, instead of the weeks or months that the FDA has taken to respond to the recent spate of problems first with antidepressants and then with Vioxx, Celebrex, and other painkillers.

The launch of the safety board received both praise and criticism from Congress. It comes as the agency begins three days of hearings today on the risks and benefits of the painkillers, a session triggered by the withdrawal of Vioxx from the market last fall. Agency critics say the FDA is too closely tied to the drug industry it regulates. There also have been internal conflicts, with FDA employees who approve drugs having more clout than the side of the agency that reviews potential problems with the same products.

Meanwhile, the New England Journal of Medicine yesterday published studies showing Vioxx and Celebrex triggered heart problems much more quickly than previously known. One study, a completed review of the trial that led to the withdrawal of Vioxx, indicates that small doses of that drug began to harm hearts within just six months.

Another study indicates that larger doses of Celebrex caused excess deaths due to heart attack and stroke in as little as 12 months. The lead author of the study said the heart risk may actually be greater.

''Had we had more people, it's very possible we would have seen a risk earlier," said Dr. Scott Solomon, director of non-invasive cardiology at Brigham and Women's Hospital. ''So, to conclude from this that there is no risk before one year would be wrong."

Celebrex, Vioxx, and similar drugs in their class, called cox-2 inhibitors, were introduced with much fanfare at a time when drug advertising rules were relaxed. As safety concerns grew, prescriptions steadily dropped.

Solomon said his results do not suggest Celebrex should be withdrawn from the market, as the FDA has been pressured to do. He said that within several months, studies pointing to Celebrex's potential benefit in shrinking tumors are expected to be complete. For now, what's clear is that high doses of the painkiller more than tripled the risk of serious cardiovascular events.


more at: http://www.boston.com/business/globe...528539/?page=2

Thanks Pantos....Johnny on the spot..

Hi Rex,

It is unfortunate that we no longer have instant access to this information, but most of us here (at NT) have beat these issues to death previously on threads at OBT. I have links to it all, but the links don't work any more.

My MAIN concern, all the way through this Tysabri fiasco, has been whether the AVERAGE PwMS (not us computer/MS board savy people) are fully aware of what the potential risks are. I'm fairly confident now that the TOUCH program is ensuring that, so I'm not nearly as concerned as I used to be.

Ultimately, the conversation always seems to end up at us:

- having additional "choices"
- what "risks" we are willing to take to have another option available
- the potential for Tysabri to prove to be effective and safe for us in the long run.

It seems apparent that many people and Neuros are still continuing to proceed with caution, and given what we know/don't know at this point, I think that is prudent. However, I sincerely hope that Tysabri proves effective and safe in the long run, and I am very thankful there are people who are willing to step up to the plate to help prove it.

Cherie

http://www.latimes.com/news/nationwo...a-story-footer

Try this article kingrex. It isnt the one I had read before, but it looks like it has the info on FDA not having enough money to monitor drugs after marketing.

And thanks Pantos for providing the links about misbehavior amongst the Avonex folks. Luckily on this board, we can post links. Unlike other boards that do not allow posting links, this board allows us to back up assertions and talk on the basis of real data, and not just conjecture. That is a real strength to this board.