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Disease Sufferers Lobby at Biotech Conference
Disease Sufferers Lobby at Biotech Conference
Posted on: Friday, 11 May 2007, 21:00 CDT http://www.redorbit.com:80/news/heal...ource=r_health BOSTON _ Patients offer poignant reminders of the high stakes involved in connecting the biotechnology dots. After all, for them it's a matter of life and death. Carrie Smith was a country singer in Nashville, Tenn., with a new baby and a promising career when doctors told her in 2002 that multiple sclerosis was causing her excruciating leg pains, severe dizzy spells and other symptoms. "I wasn't able to sing. I wasn't able to be a good wife. And I wasn't able to care for my daughter," Smith said. Smith eventually began treatment with Rebif, a medication marketed by EMD Serono Inc. and Pfizer Inc. The results were dramatic, she said, adding that she felt confident enough to carry her child again and resume playing music. "I feel like my life was given back to me," Smith said. Celebrating breakthroughs in basic research and chasing big business deals are the usual focus of the nation's largest biotechnology conference. But people suffering devastating diseases sought to use BIO 2007 this week to lobby for quicker access to cures. Indeed, they were invited. Actor Michael J. Fox, who started a foundation that funds research after he was stricken with Parkinson's disease, challenged the industry to remove obstacles slowing or even blocking new cures. He argued that more progress should be expected from an enterprise driven by brilliant minds and backed with billions of dollars. "American taxpayers are funding the greatest discovery engine in the world, yet we fail to provide incentives for our scientists to convert their relevant findings into improvements in human health," said Fox, who lives with recurring tremors, in a keynote address at BIO 2007. Lori Lober, a Kansas City, Mo., cancer survivor, echoed Fox. Seven years ago doctors told Lober she had an advanced case of breast cancer that had spread. Chances of survival, they said, were slim. Lober overcame the odds thanks to treatment that included a drug produced by biotechnology industry pioneer Genentech Inc. "The traditional therapy offered me no hope," said Lober, who later founded the Touched by Cancer Foundation. It remains to be seen how well the words of Smith, Fox and Lober will be heeded. The BIO conference caters to companies touting biotech breakthroughs with hopes of attracting investor cash and state officials pitching incentives with hopes of landing economy-boosting prospects. This year was no exception. BIO 2007 drew more than 22,000 officials from around the world. Missouri Gov. Matt Blunt and U.S. Sen. Pat Roberts of Kansas were among those representing 48 states and numerous foreign countries that jostled for attention on a sprawling convention floor. Making the biggest economic-development splash was Gov. Deval Patrick of Massachusetts, a state already rich with top universities, a bustling base of venture-capital firms and a powerful hub of biotech companies. Patrick announced a plan to channel $1 billion over 10 years to build new life sciences centers, provide research grants and distribute new batches of stem cells to scientists. Kansas officials, meanwhile, drew attention to their $588 million initiative. Blunt met with company officials and talked up his plans to channel more money toward higher education and research. Such efforts are expected to help the economy. But it is also important to remember the ultimate aim of many biotechnology endeavors, Blunt said in an interview at Missouri's pavilion playing up a "Built for Biotechnology" theme. "The benefits for mankind with this technology are so tremendous," he said. "That is something we should never lose sight of. To help patients, that is what this is really about." Cracking the genetic code with the Human Genome Project and other biotech advances have spawned an era of previously unimaginable possibilities, said Greg Simon, president of advocacy organization FasterCures. Cancer, amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease), Parkinson's and cystic fibrosis are among the maladies that innovations emerging from medical research labs are likely to fell, Simon said. "In the lifetime of my generation, most of the diseases we are dealing with, if not cured, should be turned into treatable chronic diseases," Simon said. But while the science is promising, Simon said, other factors were worrisome: _Researchers must do a better job of collaborating. _More money must be directed to translating discoveries into therapies. _Greater attention must be paid to filling gaps in a system that can require 17 years to take an idea for a treatment to a new drug. "The system we have won't get there," Simon said. "We have to have a new system." Leaders at the Ewing Marion Kauffman Foundation in Kansas City also have identified the same roadblocks. They are joining Simon and others in campaigns to remove them. The federal government has been the dominant source of funding for medical research. But new organizations are emerging with the power to force changes, said Lesa Mitchell, a Kauffman Foundation vice president who helped organize and moderate a panel discussion at the conference. The Bill & Melinda Gates Foundation, The Michael J. Fox Foundation, the Stowers Institute for Medical Research in Kansas City and various initiatives of former Wall Street financier Michael Milken are among the philanthropic ventures pumping major money into medical research. Some projections, Mitchell said, indicate these private sources could soon surpass federal funding. Put simply, those who write the checks can write new rules. With federal money more challenging to obtain, scientists will respond to foundation requirements such as discoveries being announced more quickly and widely. Foundations also are demanding focus on cutting-edge areas rather than well-trod paths likely to produce successful experiments but few major advances. "We are seeing the philanthropists pushing the envelope," Mitchell said. Both patients and philanthropists are getting more attention from the industry. Jim Greenwood, chief executive of the Biotechnology Industry Organization, made sure foundations and patients had prominent slots at this year's conference. He also included them in forums aimed at matching companies with investors and peers who might work on new projects. "We are giving people the opportunity to custom-make deals in a way I don't think is happening right now," Greenwood said in a recent interview. Foundations want to pay for cures, disease groups need help and biotech companies must pursue the most lucrative projects if they hope to survive. Mixing the three groups can provide new solutions to the problems they all face. "Put all those things together and you get some really interesting combinations," Greenwood said. Darren Baker suddenly saw the significance of his life's work in a new light when he became a patient. A researcher at Biogen Idec, a Cambridge, Mass., biotechnology company, Baker was diagnosed with non-Hodgkin's lymphoma after seeing his doctor in 2003 about a pain in his chest. Baker received treatment with Rituxan, a drug developed by his employer. He described his time as a patient as a "quite eye-opening" experience and the source of a newfound motivation for his own scientific work. "Nothing drives a researcher more than to see a drug in the clinic helping people," Baker said. "I hope biotechnology continues to deliver on the promise." |
What an interesting and factual article. Thank you for sharing this, Carolyn. Being among those 22,000 at the BIO meeting this week, I agree that the CEO (Greenwood) made a real effort to include patient groups and orgs in this year's meeting.
The Parkinson's Disease Foundation's program - PDTrials - and the Parkinson Pipeline Project were exhibiting on the front end of the advocacy groups. We were flooded with visitors, and our website's hits skyrocketed as a result of us giving out cards and fact sheets. We should all be doing our part to speed up the drug & treatment approval process: 1. By considering participation in a clinical trial 2. By spreading the awareness about living with PD 3. By demanding your rights to information on research 4. By helping raise funding for research . . . and the list goes on. Have a heart - do your part! Peg |
dear peggy
I would never allow "them" to put me in a drug study - or a clinical trial
because, I do not trust what they have done to many people under the guise of medicine, look at all the lawsuits! medicine and doctors kill more people than they help, read the real stat's. they need us to be ill, I really know you have tried very hard, but money will never be enough to buy a cure, we have cures already, but the drug lords, who control most of the government aka big pharma is not going to allow cures, never forget the gdnf tradgedy!!. Death by Medicine By Gary Null, PhD; Carolyn Dean MD, ND; Martin Feldman, MD; Debora Rasio, MD; and Dorothy Smith, PhD Something is wrong when regulatory agencies pretend that vitamins are dangerous, yet ignore published statistics showing that government-sanctioned medicine is the real hazard. Until now, Life Extension could cite only isolated statistics to make its case about the dangers of conventional medicine. No one had ever analyzed and combined ALL of the published literature dealing with injuries and deaths caused by government-protected medicine. That has now changed. A group of researchers meticulously reviewed the statistical evidence and their findings are absolutely shocking.4 These researchers have authored a paper titled “Death by Medicine” that presents compelling evidence that today’s system frequently causes more harm than good. This fully referenced report shows the number of people having in-hospital, adverse reactions to prescribed drugs to be 2.2 million per year. The number of unnecessary antibiotics prescribed annually for viral infections is 20 million per year. The number of unnecessary medical and surgical procedures performed annually is 7.5 million per year. The number of people exposed to unnecessary hospitalization annually is 8.9 million per year. The most stunning statistic, however, is that the total number of deaths caused by conventional medicine is an astounding 783,936 per year. It is now evident that the American medical system is the leading cause of death and injury in the US. (By contrast, the number of deaths attributable to heart disease in 2001 was 699,697, while the number of deaths attributable to cancer was 553,251.5) We placed this article on our website to memorialize the failure of the American medical system. By exposing these gruesome statistics in painstaking detail, we provide a basis for competent and compassionate medical professionals to recognize the inadequacies of today’s system and at least attempt to institute meaningful reforms. Continued on Page 2 of 6 Medical Ethics and Conflict of Interest in Scientific Medicine Jonathan Quick, director of essential drugs and medicines policy for the World Health Organization (WHO), wrote in a recent WHO bulletin: "If clinical trials become a commercial venture in which self-interest overrules public interest and desire overrules science, then the social contract which allows research on human subjects in return for medical advances is broken."(19) As former editor of the New England Journal of Medicine , Dr. Marcia Angell struggled to bring greater attention to the problem of commercializing scientific research. In her outgoing editorial entitled “ Is Academic Medicine for Sale?” Angell said that growing conflicts of interest are tainting science and called for stronger restrictions on pharmaceutical stock ownership and other financial incentives for researchers:(20) “When the boundaries between industry and academic medicine become as blurred as they are now, the business goals of industry influence the mission of medical schools in multiple ways.” She did not discount the benefits of research but said a Faustian bargain now existed between medical schools and the pharmaceutical industry. Angell left the New England Journal in June 2000. In June 2002, the New England Journal of Medicine announced that it would accept journalists who accept money from drug companies because it was too difficult to find ones who have no ties. Another former editor of the journal, Dr. Jerome Kassirer, said that was not the case and that plenty of researchers are available who do not work for drug companies.(21) According to an ABC news report, pharmaceutical companies spend over $2 billion a year on over 314,000 events attended by doctors. The ABC news report also noted that a survey of clinical trials revealed that when a drug company funds a study, there is a 90% chance that the drug will be perceived as effective whereas a non-drug-company-funded study will show favorable results only 50% of the time. It appears that money can't buy you love but it can buy any "scientific" result desired. Cynthia Crossen, a staffer for the Wall Street Journal. -------------------------------------------------------------------------------- http://www.lef.org/magazine/mag2004/...i_death_01.htm |
Women please read!
continued from
Death by Medicine WOMEN'S EXPERIENCE IN MEDICINE Dr. Martin Charcot (1825-1893) was world-renowned, the most celebrated doctor of his time. He practiced in the Paris hospital La Salpetriere. He became an expert in hysteria, diagnosing an average of 10 hysterical women each day, transforming them into “iatrogenic monsters” and turning simple “neurosis” into hysteria.(96) The number of women diagnosed with hysteria and hospitalized rose from 1% in 1841 to 17% in 1883. Hysteria is derived from the Latin “hystera” meaning uterus. According to Dr. Adriane Fugh-Berman, US medicine has a tradition of excessive medical and surgical interventions on women. Only 100 years ago, male doctors believed that female psychological imbalance originated in the uterus. When surgery to remove the uterus was perfected, it became the “cure” for mental instability, effecting a physical and psychological castration. Fugh-Berman notes that US doctors eventually disabused themselves of that notion but have continued to treat women very differently than they treat men.(97) She cites the following statistics: Thousands of prophylactic mastectomies are performed annually. One-third of US women have had a hysterectomy before menopause. Women are prescribed drugs more frequently than are men. Women are given potent drugs for disease prevention, which results in disease substitution due to side effects. Fetal monitoring is unsupported by studies and not recommended by the CDC.(98) It confines women to a hospital bed and may result in a higher incidence of cesarean section.(99) Normal processes such as menopause and childbirth have been heavily “medicalized.” Synthetic hormone replacement therapy (HRT) does not prevent heart disease or dementia, but does increase the risk of breast cancer, heart disease, stroke, and gall bladder attack.(100) As many as one-third of postmenopausal women use HRT.(101,102) This number is important in light of the much-publicized Women's Health Initiative Study, which was halted before its completion because of a higher death rate in the synthetic estrogen-progestin (HRT) group. does this make anyone feel safe? |
CTenaLouise,
I only got formally dxd PD because I volunteered for a nerve function trial, although I'd known something was wrong with my left side for many yrs. I'll volunteer for any PD related trial I can get on to if I believe it will forward treatment - I don't believe there is a 'cure' as such. Following another thread - my L side symptoms included frozen shoulder, elbow, knee & ankle all attributed to osteo arthritis. My heart is fine. |
dear jean~ truth or consequences
Quote:
I will make this very clear There should be consequences for every script a doctor gives out. Definition: importance, significance. "Do no harm" doesn't mean the opposite Antonyms: insignificance, unimportance, worthlessness WE ARE HUMAN BEINGS not lab animals. even though I should have known this - I have put my life on the line, my only childs life on the line by trusting doctors -that are not trustworthy. I have been on drug trials - we all have - I will make this very clear I will never sign a paper stating: I will give my life and my rights to liberty up so that I may never be able to hold the BIG PHARMA responsible! If in fact they break the contract by not allowing my own body to be mine solely. and that if I have their drug in my body it then belongs to me and the pharma company -and if they put mechanical implaments in my body they become mine because they are in fact on my land / body. and they have no rights to pull the plug! I will have my rights to pull or not to pull the contract! monsanto stold a farmers land because he used their chemical he bought and paid for called - roundup and where he sprayed the roundup. the farmers crops showed they had become genetically identical to monsanto owned seed. [patented] therefore monsanto stole his land - :Demonstration: if the big pharma puts their patented chemical/ in my body it is mine -and they must be held to that contract or be sued, even if I decide to continue the use of the drug -it is now mine! even if I choose to die, it is mine! For anyone a doctor prescribes a medicine to that we have never had enter our own bodily systems - we have been put on trial for drugs! and if we get addicted to oxycontin or whatever they want to change the name to cotton candy?, and the doctors refuse to acknowlege, the doc and the pharma company are very much responsible to "DO NO HARM" and by using this drug - we wind up behind bars for buying it on the street --- because the doctors will not be held responsible to titrate us down then the doctors should be arrested as well! I took MIRAPEX - bad bad results for me! the first time I was given Sinemet - I vomited and vomitted! :confused: so I had to get another drug called domperindone to ease the extreme nausea! Every drug we take we have a chance that it will help us/ or harm us! then next step more drugs! the depression and the anxiety meds!!! Why dont we just slap a sticker on our backs that says - SUCKER HERE! Well asfar as I am concerned - they should pay us! They should be responsible for life insurance policies, if in fact we die... All professionals in the medicine world have a responsibility to "do no harm"... some actual stats from - Death by Medicine. What you are about to read is a stunning compilation of facts that documents that those who seek to abolish consumer access to natural therapies are misleading the public. Over 700,000 Americans die each year at the hands of government-sanctioned medicine, while the FDA and other government agencies pretend to protect the public by harassing those who offer safe alternatives. A definitive review of medical peer-reviewed journals and government health statistics shows that American medicine frequently causes more harm than good. Each year approximately 2.2 million US hospital patients experience adverse drug reactions (ADRs) to prescribed medications.(1) In 1995, Dr. Richard Besser of the federal Centers for Disease Control and Prevention (CDC) estimated the number of unnecessary antibiotics prescribed annually for viral infections to be 20 million; in 2003, Dr. Besser spoke in terms of tens of millions of unnecessary antibiotics prescribed annually.(2, 2a) Approximately 7.5 million unnecessary medical and surgical procedures are performed annually in the US,(3) while approximately 8.9 million Americans are hospitalized unnecessarily.(4) As shown in the following table, the estimated total number of iatrogenic (Induced in a patient by a physician's activity, manner, or therapy) deaths— that is, deaths induced inadvertently by a physician or surgeon or by medical treatment or diagnostic procedures— in the US annually is 783,936. It is evident that the American medical system is itself the leading cause of death and injury in the US . By comparison, approximately 699,697 Americans died of heart in 2001, while 553,251 died of cancer.(5) Table 1: Estimated Annual Mortality and Economic Cost of Medical Intervention Condition Deaths Cost Author Adverse Drug Reactions: to look at the charts follow this link -and go to page 2- and 3 of 6 in DEATH BY MEDICINE... http://www.lef.org/magazine/mag2004/...i_death_02.htm goodday dear jeanb. |
I am so sorry!
Quote:
dearest JackM, I am so so sorry they hurt you! :hug: I have heard this too many times, and it is very unconscionable. |
TenaLouise
I dont want to get into an all out argument, because I believe that anyone is entitled to his or her opinion. But I do want to bring some interesting information to the surface about the author of the report you quoted. Gary Null, PhD can be found in the reliable Quackwatch information. I will just show you an excerpt here - you can read the entire report on your own: Null is prone to see conspiracies behind many of the things he is concerned about. One of his targets has been the pharmaceutical industry, which, he says, "cannot afford to have an alternative therapy accepted." He promotes hundreds of ideas that are inaccurate, unscientific, and/or unproven. He calls fluoridation "deadly" and has spoken out against immunization, food irradiation, amalgam fillings, and many forms of proven medical treatment. His series on "The Politics of Cancer," which was published in Penthouse magazine in 1979 and 1980, promoted unproven methods that he said were being "suppressed" by the medical establishment. His lengthy series, "Medical Genocide," began appearing in Penthouse in 1985 with an article calling our medical care system a "prescription for disaster" and claiming that modern medicine has had virtually no effect on heart disease, cancer, and arthritis [1]. Other articles in the series promoted chiropractic and homeopathy, claimed that effective nutritional methods for treating AIDS were being suppressed, claimed that chelation therapy was safe and effective for treating heart disease, and endorsed several treatments for cancer that the American Cancer Society recommends against. His Web site contains a huge amount of misinformation and bad advice. source: http://www.quackwatch.org/04ConsumerEducation/null.html I was speaking to a patient group in Germany this past summer about the trial I participated in. There was a neurologist in the crowd who made the comment that "this trial requires invasive surgery, so entering it is risky." I was quick to respond, "Living with Parkinson's is risky, too." We have used levadopa (L-dopa - with carbidopa - Sinemet brand name) as the gold standard for 40+ years now. Yes, it works well - but it has major side effects when used as long-term therapy. I have had PD for 12 years - and I can still function pretty well. But my clock is ticking. And I guess what motivates me to help find better treatments is knowing that my children or grandchildren may get this disease. True, the clinical trial process has flaws, but it's still safer than some of these foreign countries where anything is allowed and may end up costing the participant a load of money. It is up to us to monitor the trial process and keep things on the up and up. This is one of the functions of the Parkinson Pipeline Project. Instead of boycotting the drug and treatment approval process, why not work with those responsible to improve it? Peggy |
peggy -quakwatch is like watching FOX TV
Quakwatch is not acceptable!
they are the nay sayers to everything!! not acceptable excuse... it rates right up ther with FOX TV... :rolleyes: I am not arguing with you peg, I am stating my humble opinion. here is quakwatch on the subject of mercury! we know mercury is deadly -and should not be put in vaccines Quakwatch says: The "Mercury Toxicity" Scam: How Anti-Amalgamists Swindle People Stephen Barrett, M.D. http://quackwatch.org/01QuackeryRela...s/mercury.html Quackwatch sued pdf http://www.courtinfo.ca.gov/opinions...ve/S122953.PDF |
incentives
Incentives must be provided. This includes incentives for the patient. Most don't live near a clinical trial center and know nothing about them. If physicians are paid to recommend them, patients should be paid for participating in them. Regulation is required and parameters set.
Patients should no longer accept being treated like second class citizens who should blindly follow a doctor. Housing is needed and it would be very helpful to open care centers at research universities. Even if there aren't that many clinical trials, the med students and researchers could observe and get to know PD before they start their research. Would a teacher go through a degree without ever working with a kid? paula |
Not supporting either side the fence...just the facts...although this may be considered simplistic thinking.
In the CERE-120 trail, I live 2-1/2 hours from the trial site. Ceregene is to pay all my travel expenses and room/board expenses. There is no compensation. So, is the problem with trial participation how much money is the pharmaceutical company willing to pay, or whether harm will befall me if I participate?? If both, then medical science should be halted altogether. Well, that is if human beings are going to have to participate to allow new therapies or modes of testing to continue to evolve. Also, when a new therapy becomes available are not the recipients...you and me...in a sort of clinical trial for the first 10 years or more. After all, the therapy has no long term study notes to reveal what the long term effect will be. So, I shouldn't take the new therapy until it has been scripted for at least ten years? |
Carolyn
you are exactly right about the first 10 years of therapy being a "trial" period. Think about Sinemet (carbidopa/levadopa) - it took 10 years to realize that the dyskinesias and on/off phenomena were a result of using the medication. BUT I still say that in my opinion they are better than no movement at all! Sinemet is a miracle! I can be a blob - unable to move my arms or legs, having difficulty talkiing, swallowing and turning my head, be bent over like a 90 year old - and take a Sinemet . . . 30 min. + later, I am totally "normal." If somethingn today were to work like that, we would be endorsing it all over the place! Very few times do people look at what it causes "down the road," unless it's lethal (heart problems, cancer, etc.) Then and only then do we take real note. Jean - it was wise of you to ask about transportation. This is where the patient input could have helped this trial. Sponsors should build providing transportation into their trial budget, along with providing travel for a campanion. Recruitment and retaining recruits will be faster and will stay with the program longer. Most always these guys have the money. Did you know that the estimated cost of bringing a treatment/drug from lab to market is $83 million?? (and that may be more as I havent checked the stats lately) . This includes scientisits salaries, advertising (recruitment, etc) and travel for patients, staff, etc. It averages about 18 years for a treatment discovered in the lab to reach the sales arena. We need human involvement - I dont want to rely on the reaction of a drug in primates alone (although I was the first human after successful trials in primates with Spheramine - I guess they didn't see all that much difference between us! LOL) :) Here are some questions to ask about entering a clinical trial (from the PDTrials website) Before participating in a clinical trial, talk to your doctor, family and friends. Make a list of any questions or concerns that develop in these conversations, and take these to a trial coordinator to answer. Here is a list of suggested questions that will help you to understand more about the trial you are considering: Source: http://www.pdtrials.org/front/about_...al_trials.php# What is the purpose of the study? What information is available about the treatment? What are the known side effects and what is the risk of new side effects emerging? What tests will I be required to undergo? Will I have to stop taking any medications? Will the study staff keep my doctor informed about my care? Can I drop out at any time? How will the study results be used and will they be shared with me when the study is finished? Is there a chance that I will be assigned to the control group and might not receive the treatment (might I receive a placebo)? If I respond favorably to the treatment, will I have access to it when the trial ends? How much time do I need to commit? Will I have to travel? Are there any costs associated with participating in this study? Will insurance cover medical costs if there are any? Will I be reimbursed for any expenses that I incur while participating in the trial, such as parking? Does the study include follow-up care? Other Suggestions Bring a friend or relative along to hear the discussion when you meet with the trial coordinator. Be prepared to take notes or tape record the discussion. |
it's asking too much
No, the risk is yours to take, but I do think compensation is only fair. If a paid venture, patients may be viewed as more than experiments, and patients may also be more responsible and willing to participate. Everyone else gets a cut....except the one with the most to lose.
It all goes along with the thinking that we are valuable, which has been largely missing except when we are worth $$$ to an attorney in a lawsuit. I haven't done this in any trial; haven't been in one yet. I'm interested in the duodopa trial. If I had to drive alone 2 and a half hours, I couldn't do it. So send drivers...they have the money. Unless you have someone to help, you can't easily participate. It's very very hard to travel the worse the illness gets. I'm paying big time right now for Bio, and probably won't recuperate for weeks. Clinical trials are for people with caregivers who can provide transportation and take off work, unless you are ok to drive long distances on a regular basis, or are in a trial for something early on in the course of the disease. If this doesn't change, participation won't either IMO. Once again, only an advanced PD patient really understands what clinical trials are asking of them. Carolyn if I drove as much as you do, I'd be frozen at the wheel, they'd have to pry me out of the car. paula |
Oops!
I forgot to inccude this info:
A 2003 Harris Poll Survey reported, “helping to advance science” as the most common reason for patient participation (54%), followed by “helping others with the same disease condition” (46%). Obtaining better treatment, which ranked first (56%) in the original 2001 survey, dropped to fourth (40%) in the 2003 follow up survey. source:http://www.bcm.edu/edict/PDF/Post-trial_Benefit.pdf Harris Survey, Health Care News Vol 3, Issue 10, June 16, 2003. The Many Reasons Why People Do (and would) Participate in Clinical Trials and about compensation for trial participation, sponsors need to be very careful about being accused of "buying the patient - thus inflating the success of trial results," so compensation isn't often included as part of the package. Peg |
I thought of that Peg, but it's just an excuse IMO. If they regulate the price within a range of what is reasonable according to the invasivness of the procedure, patients could adjust to the idea that just because they are being paid doesn't mean the treatment works.
I think they should have to buy the patients. They buy the animals don't they? I don't believe that patients do it first and foremost to advance treatments for mankind. They have been told to buy into that thinking. I don't mean to say there is nothing altruistic about it; but advanced patients are hoping to relieve their suffering. I think a practical, honest approach, in which patients are compensated and made able to participate would be exactly what would help mankind. Waiting for the few that have the means and the help obviously isn't. paula |
Paula
We don't disagree often, but this is one time we do. (Maybe I am misunderstanding). You are saying (I think) that if you are being asked in a clinical trial to take a pill, you would get less compensation than if you were asked to have something implanted into your brain - right? What ifi that pill was radioactive, or what if it contained live viruses, or 100 other possibilities th at could be just as risk as surgery? We don't know what will happen when we take an unknown substance within our bodies - that's why the numbers of participants gradually build as trials advance. We have enough trouble withh inflation of the placebo effect; can you imagine how that would be skewed by "buying" th e patient??? Perhaps a set cost for compensating trial participants would work, but I don't see it in the near future. For now let's make certain participants are paid for their expenses (to include time taken from work). Peg |
Second time around - lost the first one. Disagreement is more food for thought. Perhaps a pill is the same assurgery; it's not like I have this alll thought out. Placebo gets paid like everyone else in the trial of course.
Remember what the cancer survivor we had lunch with, who now advocates for child cancer patients, said about trials? He said there is no problem recruiting child cancer patients. The parents are desperate to save their children. It's the adult trials that go unfilled. Perhaps this is because there is no one to help an older disabled patient be in a clinical trial. When they can't fill the trials, they pay the doctors to recruit. That doesn't help the patient get there. Why not help the patient through monetary compensation? ok not going to belabor it.....finishing with this thought. it's not the patients that withhold data, push for higher doses for more money, take years to reveal results, bribe, I mean employ for consulting, study investigators. It's the paid stakeholders who break their own rules. With the help of patient advocates and paid participants, the ante could be raised to the professional level of expectation all around. paula |
as a business venture...
...i would consider it reasonable to approach it as such. If a for profit company is asking for my help and if such help is in short supply and also essential to the project and if there is some personal risk, then the almighty laws of the market place say compensation. And i mean stock and options for more as well as a driver and ice cream on the way home! :D
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Treating patients like animals
[QUOTE=paula_w;99286]
I think they should have to buy the patients. They buy the animals don't they? Many interesing ideas have been discussed on this thread, but sometimes passion overcomes logic. Paula, I am sure you are not really advocating that patients go backwards in time and accept being treated like animals or subjects. We can't win a seat at the table where critical decisions are made or win support for a clinical trail participants' Bill of Rights if we don't teach scientists, etc. to treat us wih respect. Sheryl |
why not ?
they big pharm -should perhaps the term "buy" is not what you want to hear?
maybe the word - EMPLOY the patients, pay them salaried wages, we aint monkeys -you can't pay them off in money -they have no use for money -rhesus monkeys like marshmallows and captain crunch according to my friend dr. greg gerhardt... :p but if we are doing life saving research, then employ us with research wages!! why not? it is very ethical, especially to the young onset patient to whom if they die -from the drug trials of which I was told, they have died -many have died. this leaves children with no parent, payment has now -become a nescessity! if they have good results I would even bargain for stock options in that pharma company... or http://www.bmj.com/cgi/content/full/330/7502/1262 BMJ 2005;330:1262-1264 (28 May), doi:10.1136/bmj.330.7502.1262 Education and debate No cure, no pay Claus Møldrup, associate professor1 |
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 |
Pharma's must prove themselves trustworthy.
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 |
trust
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_ scroll down paula |
Paula, Parkinson's Disease Association?
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 |
Vicki
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 |
words matter
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 |
1 Attachment(s)
There is tons of information about clinical trials at your fingertips, developed by PWPs with the PD community in mind:
and TONS more information...check it all out! Consider getting involved. Attachment 1276 |
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 ----------------- 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 |
Gdnf
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 |
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 |
PD Trials
I'm on three trials and am looking for more. I believe in them.
Lloyd |
FDA protects Big Pharma?
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? :rolleyes: 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. |
JAMA's Fosamax study funded by Merck!?
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. |
The US is wondering?
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. |
Quote:
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 |
Trust is a big part of the problem
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 Paula and Peg
Quote:
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 |
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