Jean,

To me, everything in this thread is very realistic and needs to be laid out on the table for change to happen. There is fear and lack of trust. There are physical and monetary problems that have to be acknowledged.

The goal is to increase and enable participation. Does it really surprise you to hear these concerns voiced? We can't just say everyone should be in a trial or don't line up for the medicine. The problems need to be talked about. I don't view it as a bad thing - it's productive.

The fear and distrust does not originate from this board. Pharmas have been creating it for years. This is about change.

paula

I'm on three trials and am looking for more. I believe in them.

Lloyd

WE HAVE A CHOICE -do we play simon says - an old childhood game,
Where Simon Says makes us do things we do not actually want to do?
or do we chose to think for ourselves?


Health
FDA runs protection racket for Big Pharma
By Evelyn Pringle
Online Journal Contributing Writer

Jan 11, 2007, 00:43


http://onlinejournal.com/artman/publ...ter_1626.shtml

Why would Americans trust the FDA to regulate the pharmaceutical industry? Since the Bush administration took office the FDA has become the industry's partner in crime.

The most notorious protection scheme put in place by the FDA and Big Pharma is the preemption policy that bans private lawsuits against drug companies in state courts once a drug and its label have been approved by the FDA.

On January 18, 2006, the FDA issued new rules for the labeling of prescription drugs, and in the preamble to the rules on page 43, the FDA says, State law actions “threaten FDA’s statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs,” requiring lay persons to second-guess its expert assessments of a drug’s risks and benefits.

So, after all of the concerns raised about the FDA's failure to protect consumers against dangerous products over the last several year, by top experts from all over the world, the FDA has hereby declared itself the sole authority on decisions regarding prescription drugs, including whether a drug's label contains adequate descriptions of indications for use, risks and benefits.

In an October 6, 2006, articled titled, "The Doctrine of Preemption," Stan Kaufman aptly refers to the new policy as the "Doctrine of Preemptive Crony Capitalism." When announcing this multi-billion dollar immunization gift to Big Pharma, the FDA told drug makers:

"We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge."

A statement saying the complete opposite was made in 1996, by the FDA's Chief Counsel in a speech that said the FDA had a "longstanding presumption against preemption" and that "FDA's view is that FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection."[

The preemption claim reverses a long-standing policy of permitting State actions intended to protect consumers and undermines the States' ability to protect their citizens, yet State and local entities were given no opportunity to object to it.

Under Executive Order 13132, issued first by President Reagan, and then reissued by President Clinton, the FDA is supposed to consult with State and local authorities about the effects of each regulation it issues that affects the States.

Nowhere in the proposed rule did the FDA provide notice or seek comment on the preemption provisions added to the preamble.

if you want to have your drug given approval -fund the study Merck does?

JAMA's Fosamax study funded by Merck
By Martha Rosenberg
Online Journal Contributing Writer

Jan 9, 2007, 00:46

Email this article
Printer friendly page


Let no one say the studies in JAMA are funded by hidden drug company money. The funding is right out in the open.

http://onlinejournal.com/artman/publ...cle_1615.shtml

"Effects of Continuing or Stopping Alendronate After 5 Years of Treatment," in the December 27, 2006, issue of JAMA was funded by Merck that manufactures alendronate, a bisphosphonate, under the patent name Fosamax.

Not only was the study "supported by contracts with Merck and Co.," according to JAMA, it "was designed jointly by the non-Merck investigators and Merck employees" and written "with editorial input from Merck throughout the process."

Want further transparency? "The final version of the manuscript was approved by all coauthors, including Merck authors," says JAMA.

The study's 11 non-Merck authors disclosed 40 research grants, consultancies and other financial relationships with drug companies including Eli Lilly, Pfizer, Roche, SmithGlaxoKline, Wyeth, Novartis, Procter & Gamble and, of course, Merck.

And the three Merck authors disclosed they "potentially own stock and/or stock options" -- as if working for Merck weren't enough of a conflict of interest.

Dr. Cathleen S. Colon-Emeric who wrote an accompanying editorial, "Ten Vs Five Years of Bisphosphonate Treatment for Postmenopausal Osteoporosis," and discloses she has received money from Novartis, even appears on an "Understanding Osteoporosis" Novartis web page.

It's a good thing Editor in Chief Dr. Catherine DeAngelis has cleaned things up since the scandals about JAMA authors taking undisclosed drug company money earlier in 2006.

Of course the osteoporosis market is big -- the malady "grew" from half a million to 3.6 million when bisphosphonates were introduced in the mid 1990s, says the Associated Press with tongue firmly in cheek -- and Fosamax is Merck's second biggest performer.

Merck even presciently went into the bone density measuring equipment business, says Maryann Napoli of the Center for Medical Consumers, so patients wouldn't have to go too far to be told they had osteopenia (which they all had) -- a term that also appeared when bisphosphonates did, meaning low bone mass or low rate of drug sign up, depending on whom you ask.

But there were a few wrinkles in the bone-anza.

U.S. wonders if Zyprexa drug data was accurate
By Alex Berenson

http://www.iht.com/articles/2007/04/...ess/25drug.php

Wednesday, April 25, 2007
The Food and Drug Administration is examining whether Eli Lilly & Company provided it with accurate data about the side effects of the antipsychotic drug Zyprexa, a potent medicine that has been linked to weight gain and diabetes.

The FDA has questions about a Lilly document from February 2000 in which the company found that patients taking Zyprexa in clinical trials were three and a half times as likely to develop high blood sugar as those who did not take the drug.

That document was not submitted to the agency. But a few months later, Lilly provided data to the FDA that showed almost no difference in blood sugar between patients who took Zyprexa and those who did not.

The FDA confirmed its inquiry in response to questions from The New York Times. The agency said it had not yet decided whether to take any action against Lilly.

"The FDA continues to explore the concerns raised recently regarding information provided to the FDA on Zyprexa's safety," Dr. Mitchell Mathis, a deputy director in the psychiatry division of the agency's center for drug evaluation and research, said.

A Lilly spokesman, Phil Belt, said the company had rechecked its database and found errors in the original statistics. The data submitted later was accurate, Belt said.

But the 2000 document said that its figures had already been checked for error. The Times disclosed the existence of the document in an article last December.

The discrepancy between Lilly's initial data and what it later submitted came at a time when Zyprexa's sales were soaring, even as some doctors and foreign regulatory agencies were questioning the drug's safety.

The FDA has never concluded that Zyprexa causes diabetes more than other widely used psychiatric drugs, although the American Diabetes Association has.

Zyprexa remains Lilly's top-selling drug, with $4 billion in worldwide annual sales. But prescriptions in the United States have fallen nearly 50 percent since 2003 amid the safety concerns.

Zyprexa and other antipsychotics are intended to quell the hallucinations and delusions associated with schizophrenia and to treat some cases of mania.

The document from 2000 and others were provided to The Times by James B. Gottstein, a lawyer who represents mentally ill people he says are forced to take psychiatric medications against their will.

Besides the FDA inquiry, Lilly is facing U.S. and state investigations into the way it marketed and promoted Zyprexa. The company has already agreed to pay $1.2 billion to settle 28,500 lawsuits from people who contend that they developed diabetes or other diseases after taking the drug. At least 1,200 more lawsuits are pending.

Belt, the Lilly spokesman, said in a statement that the company properly marketed Zyprexa and disclosed its side effects to the FDA and doctors.

"Lilly always cooperates fully with requests for information from the FDA," he said, "and that includes any requests regarding information on Zyprexa. Lilly is forthcoming with all relevant clinical data on all of our products."

Lawyers who represent drug companies said the FDA largely depended on the companies to be honest about the side effects of their drugs. With a staff of fewer than 3,000, including support personnel, the agency's drug division oversees more than 12,000 prescription medicines and 400 nonprescription drugs.

In most cases, said William Vodra, senior counsel at the law firm of Arnold & Porter and a former FDA associate chief counsel, it does not perform detailed audits of clinical trials or independently check the integrity of the data that companies send to it.

"There's no way they could police the system with the resources they have," Vodra said. Companies provide the agency's scientists with so much information that "there is a point at which you can't even think about what they've given you," he added, "let alone what's behind that stuff that they may not have given you."

Robert Dormer, a partner in the law firm of Hyman, Phelps & McNamara, who represents drug companies, said that the companies did not have to provide every analysis they performed to the FDA "Companies do lots of drafts of things," Dormer said.

The Zyprexa document that has aroused the most interest at the FDA is a Feb. 21, 2000, paper in which Lilly scientists discussed whether Zyprexa's label should be changed to alert doctors of the risk of hyperglycemia, or high blood sugar, associated with the drug.

The paper showed that 154 of 4,234 patients, or 3.6 percent, who took Zyprexa in clinical trials developed high blood sugar. Only 1.1 percent of patients who took a placebo developed the condition.

Doctors have said that difference is worrisome because most patients in the clinical trials were taking Zyprexa for only a few weeks or months. Untreated hyperglycemia can eventually lead to diabetes, a disease in which the body's insulin-producing cells die and patients lose the ability to regulate their blood sugar. Diabetes is the sixth-leading cause of death in the United States.

The data that Lilly provided to the FDA was notably different from the results discussed in the February 2000 paper, with the gap between the two patient groups much narrower. The company told the agency that patients taking Zyprexa developed high blood sugar at a 3.1 percent rate, while those taking the placebo had a 2.5 percent rate.

Belt said that after the February 2000 paper, Lilly performed a final quality check of the data and discovered that some patients had been incorrectly included in the analysis, while others had been excluded.

"The original data referred to in the memo was a preliminary analysis, not the final accurate analysis that was provided to the FDA, and is therefore very misleading," he said.

The Times reported in December on the existence of the February 2000 document, as well as other company documents and e-mail messages that contradicted public statements by Lilly about Zyprexa's risks.

Lilly has said that the documents and e-mail messages were taken out of context and do not present a balanced view of Zyprexa's risks and benefits. A U.S. judge has criticized The Times for violating a protective order that covered the documents.

Jean,

Everyone gains with an interest in research when they decide to unite and show big pharmaceutical industry that they will not do anything (research) to save their lives. We may be down but we aren't out. Some of us choose to let pharma industry demean us by letting research do "for profit" off of us and not let us know the full extent of what we are risking our lifes for. I do not support compensation for participating in research which is not designed for marketing purposes and will result in an open patent policy. An open patent policy would ensure that all the results will be shared within the industry so all may profit, pharmacertical industry, universities, and patients.

Change means suffering for a cause bigger than oneself. Sometimes not participating in the "status quo" will create a change that will benefit more people than to continue the "status quo." The people who are not participating in research are not doing it for selfish gain or for selfish reasons. Those who are refraining from participation in research, consciously, have used the American enterprise system to let the pharmaceutical industry learn that trust must be earned and not assume it as their right because they are in an industry in a position to help sick people. They are also in an industry operating on an open market policy where they have slammed the doors through patents and imports of cheaper drugs from other countries. The drug industry does not operate as a free market enterprise system. Many of the board of advisors of the FDA are also pharmaceutical or former pharmaceutical board members which would indicate a conflict of interest in the FDA.

I also hope my posts will cause a few folks to consider it.

Vicky

And the big pharmas have no one to blame but themselves on that. Without finding a way to regain that trust the problem will remain.

I would be tempted to participate in a system that incorporated patients from design forward, shared profit if thwas appropriate, and provided follow up care if things went wrong or access to the medication if it worked. In short, a fair collaboration between the parties that recognized our mutual needs for one another.

After talking at length with Paula (and I invite any of you to do the same), I think she is being grossly misunderstood in her earlier comments. Paula in no way is saying “do not get involved in clinical trials.” And she is not to be taken literally when she said drug sponsors should “buy the patients.”

For clarification (and I chose to answer here on my own – it was not Paula’s idea), Paula is a strong promoter of entering clinical trials. She has her daughter and 4-yr-old grandson living with her, and she is on disability retirement, so entering a trial isn’t exactly an easy task. Like many, she is holding out for a cllinical trial that meets her needs as well as one for which she feels will contribute to and/or address finding a cure. We all should select what trials we enter cautiously – the trial must be a reciprocal agreement between the sponsor and the patient. Risks must be carefully weighed against benefits. She uses “buy the patient” synonymously with “pay the patient” for trial participation. Who knows? This may be the answer to the trial recruitment deficit.

Obviously, Paula’s comments have been exploited here. There shouldn’t be any concern about her comments falling on the virgin ears of newly diagnosed and causing misrepresentation. She has cleared that up nicely. And one should not be judged by whether or not they have been trial participants. As a former educator, Paula knows the value of a healthy, multi-sided debate on an issue. She is simply exercising her right to choose what best fits her family and schedule .

Peggy

Sorry if my posts are causing you stress. Will stop posting. Sometimes someone starts to argue a view, and the person who starts the posting loses interest or the stamina to continue argueing their view, especially if she is on a first name basis with her oponents. She may not want to cause anger or lack of support for others. I will stop posting to stop any pressure on Paula or Jean or anyone else on this board.

Vicky

Vicky
I started to send you a private message, but I will do both to be sure that you receive it. I am NOT directing anything to your remarks. I believe the people know to whom I was addressing my remarks.

Enough said. Everyone is entitled to his/her opinion here - just be certain that when there are big concerns that he/she go directly to the source to question it.

Peggy