Absolutely not Vicky - this is what a forum is all about. Peg thanks for the vote of confidence. Dottie your reason for participating is about as real as it gets...Rick......i suggest you read more of the pipeline site. you are starting to talk like one.


paula

Excerpts From Overdosed America

http://www.overdosedamerica.com/pages.php?pageid=31
Chapter 14:
written by Harvard Dr. John Abramson


This is the mother of all sleights of hand: the transformation of medical science from a public good whose purpose is to improve health into a commodity whose primary function is to maximize financial returns. As a result of this sleight of hand, the gap is widening between the scientific evidence that impartial experts (not paid or threatened by the medical industry, not biased by other personal concerns, and granted unrestricted access to all of the evidence) would agree upon and the perceptions that actually drive American health care. This growing gap is at the core of the crisis in American medicine. And why are we surprised? The drug companies have no more responsibility to oversee the public's health than the fast-food industry has to oversee the public's diet.

The substitution of narrow corporate interests for medical progress has produced some dramatic excesses. When the manufacturer of Paxil performs nine clinical studies on the treatment of adolescents for depression and finds that Paxil is no more effective than placebos and, in fact, significantly increases the frequency of "emotional lability� (including suicidal thoughts and attempts), it's no problem. The company publishes one study that shows a benefit, fails to publish the other eight, and markets away. When British drug authorities spill the beans? No problem. A task force of the American College of Neuropsychopharmacolgy is convened, and concludes that the new antidepressants are safe for adolescents after all. Too bad the task force didn't have access to some of the information that was available to the British drug authorities. But perhaps that didn't seem like so much of a problem, because, according to the New York Times, "Critics of the medicines noted that 9 of the 10 task force members had significant financial ties to the pharmaceutical industry. . . .� (However, the task force insisted that no industry money financed their report.) What to do when the FDA epidemiologist in charge of analyzing all the antidepressant studies involving children concludes, just like the British drug authorities, that twice as many children treated with the new drugs (except Prozac, which is available as an inexpensive generic) became suicidal, and that the FDA should therefore discourage doctors from treating children with these drugs? Just bar the expert from testifying at the FDA's public hearing. Then don't make him available for an interview with the New York Times, which reported the story on April 16, 2004

You don't like the way the study of an expensive drug for blood pressure is going? A nonissue -- just stop the study before the results reach statistical significance.

Endovascular Technologies (a wholly owned subsidiary of Guidant, the company that manufactures implantable defibrillators) manufactured a $10,000 device to repair aortic aneurysms that dangerously malfunctioned in a third of the 7600 patients in whom it had been used. Did this frequency of malfunction stop Endovascular Technologies? No. The company reported 7 percent of these events to the FDA and sold on. According to a plea agreement entered into with the United States government in 2003, the company belatedly disclosed another 2628 serious malfunctions and 12 deaths. No problem. It agreed to pay $92 million to cover criminal and civil penalties and then picked up with business as usual on other products.

Your drug company just received an official warning letter from the FDA for the "false and misleading� marketing of Celebrex, Vioxx, Pravachol, or OxyContin? No problem. The FDA's corrective action is unlikely to displace the false information already firmly planted in the public's mind.

And the list goes on. Controlling medical costs in this near free-for all commercial grab is not just impossible, it is a contradiction in terms. Does it make sense to talk about reducing national expenditures for cars or clothes or beer? Medical care, by far the largest consumer commodity in the United States, is now no different.

Peg,

Working with you on the Parkinson’s Pipeline Project for the last several years, I came to respect your intelligence, integrity, and work ethic. It was with great sadness that I recently left the group to pursue my own areas of interest. I had no idea how this would fracture our relationship and jeopardize causes far bigger than either of us.

Your efforts to defend Paula’s posts on this thread misrepresent clinical trial recruitment issues, and have silenced those who disagree by falsely accusing them (although not by name, but including me) of “exploiting” Paula’s comments.

You say Paula is being “grossly misunderstood” when she uses “buy the patient” synonymously with “pay the patient” for trial participation (above and beyond out of pocket costs). Who knows? This may be the answer to the trial recruitment deficit.
Based on all that you have read on this topic, do you really believe that this is even among the top five reasons for patients’ reluctance to participate in clinical trials?

If, as you say, Paula “knows the value of a healthy, multi-sided debate on an issue,” how is it that communication has broken down to the point that you jumped in to mediate ane Carolyn and Jean removed all remnants of their posts from this thread? We must “police ourselves,” seeing to it that everyone feels safe and comfortable expressing their own opinions on key issues facing the larger Parkinson’s community.

As patient advocates are starting to make real headway in “gaining a seat at the table,” this is the time to pull together, not split apart.

Sheryl

Sheryl,

Enough. This is a forum, a forum is a place to exchange ideas.

If I need an editor or any more lectures on what words to use, I'll call someone who doesn't twist and manipulate them.

paula

Sheryl said: As patient advocates are starting to make real headway in “gaining a seat at the table,” this is the time to pull together, not split apart.

I could not agree more. And as far as I am concerned, our relationship is the same - not fractured. I also respect you for your opinion, although it is sometimes stronger than comfortable for me. You are an extremely talented writer. We worked on a project together (the infamous "article") and did so quite harmoniously.

It is not my nature to lash out, except when backed into a corner . I dont know why comments in this thread were removed - I suppose it was individual choice. But this thread is closed as far as I am concerned.

Now, let's see who is truly dedicated to getting on with the challenge of finding better treatments (see - I'm even settling for less than a cure!) lol

Peggy

Peg,

I'm with you on getting on with the challenge of finding better treatments and did not mean to direct my anger at you.

In a show of good faith, I will not answer Paula's last post. Her words make my point.

Sheryl

please read your private email -

rules of parkie spellin' ettiquette -if ya please!
do not shoot our spelling or grammer down... okie dokie!
we are blessed to crawl to the pc some daze...
anywho - I believe it is a parkies perogative to spell -or spell words artistically...
peace,
tenalouise

Should have done this sooner:

http://www.fda.gov/oashi/clinicaltri...ntrialdoc.html

Other considerations:
Payment/compensation:

• Subjects are sometimes paid for their participation in research, especially in the early phases of investigational drug, biologic or device development. Payment to research subjects for participation in studies is considered a a recruitment incentive. Financial incentives are most often used when health benefits to subjects are remote or nonexistent. Volunteers may be offered compensation in certain trials for their time, and for discomfort that may be experienced during the trial. The amount of compensation is determined by the amount of time you will be required to dedicate to the trial, and to the level of discomfort that might be associated with medical or surgical procedures related directly to the study. Payment information, including the amount and schedule of payment(s), as well as any possible costs to volunteers who participate in a study, are discussed with potential participants during the informed consent process, and documented in the informed consent form.

please hold the stirring the pot up again accusations... especially if you are not going to acknowledge why I posted this. I would have done it yesterday if I had thought of it. One thing this thread did NOT lack was transparency.

the end,
paula

Hi Paula,

I and my husband both received $50.00 compensation for participating in a focus group regarding ethics and DBS surgery. It is already practiced by some research.

Vicky

Paula, you've made it very clear you believe people should be paid for participating in trials. As you say - transparency!

Thanks for posting.