Sheryl and Jean,

Peg used the words buy the patients and i reitereated them, actually meaning "compensate the patients" and added that they pay for the animals.

I think my meaning has been pretty clear. I'm talking about enabling more people to participate. It was also stated that i thought we were of value and deserve to be compensated.

I don't understand your point; perhaps you misunderstood mine.

paula

I must agree with Tina. Alot of research is for marketing purposes only and the patient is unaware of the purpose of the research. Many times researchers are using patients, who believe they are making a difference for the future patients with their same illness, to prove their product is better than a different companies product used for the same purpose, ie., lower cholesteral, sleep aids, arthritis sufferers, etc. If patients are to be used in this way, they should also receive a portion of the increase of income received by the researchers for the hosting pharmaceutical company.

What about patents? Phaarmaceutical companies say they need them to be able to pay for the reseach money spent to gather the information. But if the company is allowed to withold information about a patient's test results that the patient could use to make educational desicions of how to treat their illness, are the researchers putting the patient or their profits first by witholding the information?

Pharmaceutical companies claim to live by the free enterprise system are not being truthful. By heavily lobbying to keep import drugs out of the US, they are only competing with each other. Which explains why Americans pay the highest prices for drugs. All the other countries pharmaceutical companies are policed by their governments.

I am not suggesting anyone should stop participating in research trials. I am saying that patient's rights and health should be considered by the pharmaceutical Industry to take priority over profits. Pharmaceutical companies have alot of work to do to prove they are trustworthy. The traditional "you will be helping to find a cure for future patients with ___________." Fill in the blank with the name of your illness just won't cut it anymore.

Vicky

Vicky and Tena,

Trust is the issue, you hit it right on the head. We are working on it and welcome suggestions.

Marshall Loeb wrote this summary of the first round table conducted by PDF and Pipeline. He is the former editor of Fortune magazine and is now a PWP and FDA patient consultant.

http://pdpipeline.org/advocacy/anewe...linical_Trials_

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paula

I am a patient of a National Parkinson's disease Foundation Center of Excellance. I have received excellant care from them. My experience with a PDA group was most unpleasant.

What does a FDA patient consultant do? I have never heard of the title. What power does he have in deciding how the pharmaceutical companies do research? Also, why does the pipeline proposal not include explaining clearly to the patient the goal of the research, for example, is it a study of a drug already patented by the company and the study intention is to prove their patent is superior to a copycat drug by a different phamacy company?

Will the pharmaceutical industry be allowed to peddle their products directly to the consumer through TV commercials? This practice leads to the creation of consumers believing they need drugs for shyness, overweight, wondering if they have ADD, and other problems that were not treated by drugs. America is the only company that allows this practice. Pharmaceutical companies call it educating the public and freedom of speech. Freedom of speech comes with the responsibility of speaking out for the good of the American public. The pharmaceutical industry should not selectively edit out anyresearch results which would make their drug look weaker Pharmaceuticaal Industry should also compare also compare apples to apples. They should use equal amounts off each ingrediant of the drugs.

Clariton was compared to another allergy product and had TV ads claiming that Claiton did not leave patients sleepy. This was only true because the dose of Clariton was a much smaller dose.

I am going to bed as I can hardly keep my eyes open. Hope all of you have a good nights sleep.

Vicky

Vicky
You haven't heard of an FDA consultant because there has never been one! This is a new wave of thinking - get the patient involved in the drug approval process. Perry C. holds one of these seats at present. He can explain it better than I.

I am working on a short, clear explanation of various ways that patients can bring their expertise to the approval process. I will post it here when it's finished. Of course helping spread the word about trials available and helping with recruitment are obvious ways to help.

And I'm not a big promoter of advertising (direct-to-consumer) on TV either. However, that is the only way that some brand names are known for some patients. Their doctors don't keep them informed of what's new.

More when it's available.
Peggy

Paula,

As a writer, I am a person who believes words matter. I know you didn't intend to equate human trial participants with animals. Both of us have been in the trenches long enough to know what it's taken to change this attitude, and we surely don't want to give back any ground.

In our writings, we must remember that many newbies lurk here (as we once did) hoping to come across information that will help them better cope with Parkinson's. They don't bring the same experience to the discussion as we do and can easily misinterpret things if we don't choose our words carefully.

Though I used your words as an example, my cautionary reminder extends to all of us veteran posters. I hope this clears the air between us.

Sheryl

There is tons of information about clinical trials at your fingertips, developed by PWPs with the PD community in mind:

Facts About Clinical Trials: answers to 12 basic questions

Recruitment and Retention:

• Clinical Trial Facts
• Recruitment and Retention of Clinical Trial Participants
• More effective recruitment can stem rising costs
• Advocates positively impact clinical trials
• Involving participants improves retention

Risks and Benefits Tradeoffs

• Medical Progress Requires Calculated Risks
• Risks and benefits vary with trial type, phase
• FDA: Managing risks of clinical trials
• Securing approval for public use of new treatment

Informed Consent and Participants’ Safety

• Who/What Ensures Clinical Trial Participants’ Safety?
• Investigational New Drug Application (IND)
• Institutional Review Boards (IRBs) approve protocol
• Informed consent process

To Participate or Not to Participate in Clinical Trials


Placebo Effect in Parkinson’s Disease


Outsourcing Clinical Trials Gaining Popularity

Better Reporting of Clinical Trial Results Will Speed Development of New Trials,
Enhance Safety of Research Participants, and Promote Practice of Evidence-Based Medicine

Carolyn,

It is a personal choice and your explanation is appreciated. Clinical trials are coming to the forefront like never before , but they don't have a very good reputation. I'm sure compensation hasn't occured to most people, but then we are looking for increased participation are we not?

For a change to take place, something has to be changed. Sharing your experiences is very important but in the end it is a personal decision not to participate as well. We have been striving to keep people informed; but bottom line is clinical trials involve taking risks and people need assistance.

In other words, you may be stronger than many typical pwp with as many years of PD under their belt, which is a good thing. I'm not trying to take away from what you are going thru to get there....it makes me tired by just reading it. I truly admire your determination and hope we all benefit from it.

Vicky,

PDF (Parkinson Disease Foundation) does not have groups. Could it have been some other group? Both the FDA consultants and the FDA are feeling their way at how best to use the patient advisors. There are many regulations that must be navigated but they were recently included in the meeting about pulling Permax off the market.

Here is the Pipeline Project Strategic Plan, which is ever changing with events and time. We are supported by the Parkinson Disease Foundation.

http://pdpipeline.org/aboutus/stategicplan.htm
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In all these situations, I think one of the main things to keep in mind is that we are all different. With any form of advocacy, we all bring our personal stories to the table but they are not at the forefront. Striving for changes that will benefit all should be the goal. The more 'me' in the process, the less successful you might be.

People can't be forced, nor should they feel inferior if they do not participate in clinical trials. But we can try to make this a better process, a more successful experience for those who do and that is what we are striving to do. We want patients to be informed enough to manage their own course with the help of their physicians.

paula

Paula and Carolyn,

The patients who participated in the GDNF trials, as I understand it, were told they were testing GDNF as a potential treatment for Parkinson's disease patients. The pharmaceutical company later claimed they were testing not GDNF but the delivery system. When the test was showing that GDNF was showing positive results, the patients' considered the test to be successful and felt since they took the risk they earned the right to be the first beneficiaries of the drug.

The pharmceutical industry chose not to tell the patients the entire truth of what the research was for. After GDNF was prooven to be successful, the Pharmaceutical industry pulled the plug of funding and now claimed they were doing research on the delivery system to see if it would be adequate to deliver the GDNF in the right amount to prevent it from causing tumors or to quick growth of dopamine neurons.

The pharmaceutical industry has lost its trustworthyness. They lied to the patients convincing they were doing something for the benefit of humanity and left out the danger the participants would be in. Perhaps the pharmaceutical industry decided that since the patients were close to dying anyway, they may as well make themselves available for dangerous research.

No, the pharmaceutical industry has blatently proven themselves as untrustworthy. Does the needs of the many outweigh the needs of the one? Does the pharmaceutical companies "right to know" come before the value of a human life? An individual choice indeed. What of the family members who love that human life and will not agree with the assessment that the individual should sacrifice their life over the family who values the patient's life to the very end. Does the patient blindly trust the pharmaceutical Industry and risk removing themselves from family that loves them for who they are and not the term of their life?

What a difficult discussion.

Vicky

Vicky,

I have never heard it stated that Amgen was actually testing the delivery system. They do now say that the delivery system is the problem. Not to rehash, I'll simply say that a different pump was recommended; but not FDA approved. But for some of the participants, even that pump worked miracles.

paula