Perry's explanation of the project is very thorough of course, but I'd like to try to clarify what it is we are doing. I'm seeing too many assumptions, misunderstandings, and hopefully, this forum may turn out to be a good thing.

The purpose of the pipeline site and database is for patients to manage their own course with the help of their doctors of course. You will possibly discover that you are more current than your neurologist about some things. That's not a bad thing....and hopefully your neurologist won't be threatened by it. They are busy in the trenches with what treatments we've got.

When a discussion goes on about a topic, it should not be assumed that anyone is for or against anything. A discussion or debate, is supposed to be beneficial, not adversarial, and we are not going to always agree.

On the topic of sham surgery, the issue isn't whether or not I believe in it; it's being presented for you to make your own decisions. IT's one of the issues that patients are bringing to the table for discussion. In another thread, it was mentioned in a context that sounded like we were against it; when actually it would be more accurate to say we are questioning it in the context of not only being risky but also to save time. An article is coming out soon explaining this and as you'll see, people have different opinions.

So I think the less we view things as his way or my way, or for and against, and instead look at the validity of patient issues that come up with an open mind, the purpose of forums like these will be fully and best served.

This is not a criticism; repeat- this is not a criticism. There are no wolves in the forum.....a few grumpy bears from time to time but no wolves.

sincerely,
paula

As I was reading the Forbes article, I was thinking -why are we taking all these risks?

I don't understand why people are lining up for drug trials that will give them heart attacks -
here is what I was reading...Keep thinking outside of the box, it will save many lives...dear Paula.






Avandia
Open-Source Drug Safety?
Matthew Herper 05.22.07, 6:00 AM ET

In fall 2005 and again in August 2006, GlaxoSmithKline shared shocking news with the Food and Drug Administration. When 42 different studies of its diabetes drug Avandia were combined, the drug appeared to raise patients' chances of having a heart attack by 30%.

More than a million Americans take Avandia every year; the risk Glaxo had found would mean thousands of extra heart attacks. But the company argued that the risk only occurred in patients who already had serious heart problems, and that it didn't show up in long-term clinical trials. The FDA made no decision, and no public statement.

Monday morning the New England Journal of Medicine released a study by Steven Nissen, chairman of cardiology at the Cleveland Clinic. Without knowing about Glaxo's own analysis, he had plowed forward with his own evaluation. Using Google, he found a Web site on which Glaxo listed all of its clinical trial results. He looked at 42 clinical trials, and counted the number of patients who had heart attacks.

The patients who got the medicine were 43% more likely to have a heart attack, and 64% more likely to die. Nissen's conclusion mirrored the one Glaxo had found in its own study. While he admits that there are problems with smashing different studies together, he is concerned. "It really is very serious," he says.

Nissen sent the results to the New England Journal of Medicine, which rushed to publish them. The FDA said in a statement that it didn't know if there the data should change the way patients are treated, but would convene a panel of experts to weigh the risks and benefits of the drug. Timothy Anderson, an analyst at Prudential Equity Group, predicts the result will at the least hurt Avandia sales as patients switch to competing medicines from Merck and Takeda.

This story has repeated again and again over the past six years. An independent doctor assembles all the available data on a drug or medical device, and finds it dangerous. Vioxx was among the first drugs felled this way (Nissen co-wrote that analysis.) J&J's Natrecor, for heart failure, saw its sales plummet after to cardiologists called its safety into question. Pargluva, from Bristol-Myers Squibb, was never approved after such an analysis. It was an analysis of published clinical trials that raised the first big questions about drug-coated stents causing heart attacks in rare cases.

Now, this kind of pharmaceutical vigilantism is set to become the order of the day. Both houses of Congress are expected to pass laws that tweak the way the FDA monitors the safety of new medicines after they are approved. Many of the most radical changes, like a proposal to restrict TV ads and a push from Grassley to set up a separate FDA division to monitor side effects, didn't make it into the Senate version. But the bill would compel drug firms to make all of their data available on public Web sites. That, in turn, would let academic watchdogs like Nissen troll for side effects more easily.

It's an open source approach to drug safety.

Some doctors already say that the safety conclusions drawn from such analyses don't necessarily help them decide how to treat their patients. "It's great that they're identifying a potential problem, but to have it as a lead article in the New England Journal is not sensitive to the consequences" for patients who might stop taking their medicine, says Stuart Weiss, an NYU endocrinologist. James Underberg, an NYU cardiologist, complains that drug safety experts are too eager to use studies to answer questions they were not designed to answer.

But drug safety experts say that the problem is that this is the best data available--and that the FDA, because of lack of authority to force drug firms to do anything, has not been able to mandate large studies that would answer safety questions. "This is the best data we have right now," says Bruce Psaty, a drug safety expert at the University of Washington.

The FDA's ability to track drug side effects is "a joke," says David Nathan, a diabetes drug expert at Harvard Medical School who reviewed Nissen's paper. " What Steve Nissen did was appropriate and clever." Adds Curt Furberg, from Wake Forest University: "In the U.S., we don't take action. Drugs are approved and then we discover problems down the road."

GlaxoSmithKline says it disagrees strongly with Nissen's analysis, and with the criticisms being leveled by Grassley and other legislators. It points out that it did share its meta-analysis with regulators both in the U.S. and in Europe--although it declines to comment on the timing of those meetings. And the company says big clinical trials it conducted show no cardiovascular risk.

But the very clinical studies Glaxo is using as its defense are the ones that Nissen says inspired him to look into Avandia's heart side effects in the first place. He also argues that it is not clear all this secrecy is actually helping drug makers in the long run.

Avandia works by hitting a drug target called the peroxisome proliferator-activated receptor (PPAR) gamma. PPAR gamma is one of three PPAR receptors, master switches on the cell surface that control muscle growth, metabolism and the processing of fat and sugar. The first of these PPAR receptors was discovered 17 years ago, and for a long time many researchers, including Steve Nissen, thought drugs designed to hit them might prevent heart attacks.

But a drug that trips a PPAR switch fires up dozens of genes, and side effects for these medicines have proved unpredictable. The first PPAR drug, Rezulin from Pfizer, was pulled from the market in 2000 because of liver side effects. More recent entrants from Bristol-Myers and Eli Lilly have also failed because of side effects. (Nissen did the analysis that showed problems with the first, and the clinical trial of the second.)

Over the past six years, Nissen says, drug firms have started testing 50 drugs that work much like Avandia. Not one has made it to market. If the results of all those failures had been shared, not buried, it's possible that drug companies would have spent a lot less time, brainpower and money on experimental medicines that were never going to work.