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taffylinden

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An article in last month’s New England Journal of Medicine revealed that 83% of the larger patient advocacy groups are funded in part by major pharmaceutical companies. What’s wrong with that? 

“If you’re a policymaker and you want to hear from patients, there’s a danger if there’s an undisclosed or underdisclosed conflict of interest,” said Matthew McCoy, the paper's primary author. “The ‘patient’ voice is speaking with a pharma accent…These possible conflicts of interest are troubling, experts say, because while patients and drugmakers both want better treatments, they often have opposing goals…

 “Patients want cheaper medicine; the pharmaceutical industry wants to maximize revenue. Patients want information about the efficacy of certain drugs; the industry often seeks faster approvals for drugs — at which point the incentive to collect information about a drug has diminished, according to Vinay Prasad, assistant professor of medicine at the Oregon Health and Science University…

“Who is setting the narrative of what patients want?” he said.

https://www.usatoday.com/story/news/2017/03/01/patient-advocacy-groups-pharmaceutical-dollars/98593458

Is the LFA one of that 83%? Yes. I can’t access the list of 104 patient advocacy groups, but I only had to go to the LFA site. (The LFA consistently rates highly in terms of transparency.) All four of the “$100,000 +” donors listed on the LFA site are pharmaceutical companies, as were many of those in the other ranges.


I'm grateful to the LFA for many things, including these message boards, but I want to know how it plans to ensure Big Pharma doesn't influence research or policy and doesn't speak for us patients or determine how our voices are heard.

 

 

lupuscommunity

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As Taffylinden has noted, the Lupus Foundation of America is very transparent in acknowledging support from industry.  There are many reasons that industry supports the Foundation.  First, we have a program that provides training to clinical investigators on the use of instruments used in clinical trials of potential new therapies for lupus.  The online resource, http://www.lfa-point.org provides training for clinical investigators who are participating in a clinical trial on the consistent use of these instruments used to measure disease activity and response to treatment.  These instruments are necessary to provide evidence to the US Food and Drug Administration that a potential treatment is safe and effective for use.  

The Foundation also has been engaged in a multi-year study to develop a new instrument that would be more sensitive to the changes in disease activity.  This instrument, The LFA-REAL System, has both a physician and patient component.  Industry has been helping the Foundation to fund development of this new instrument that could have a profound impact on the outcome of future trials of potential new lupus therapies.  

To date, only one drug within the past 60 years has been approved that was specifically developed for lupus.  One drug will never be enough to manage a disease as complicated as lupus.  The Foundation has been working to improve the design of clinical trials in lupus as a way to help speed development and approval of new treatments that would provide a more effective and more tolerable alternative to steroids and immunosuppressant agents that today make up the main arsenal to manage this disease.  

The Foundation also has a program to educate people with lupus on everything they need to know about participating in a lupus clinical trial.  The Foundation has established the Center for Clinical Trials Education, http://www.lupus.org/clinicaltrials  that not only provides important information that is necessary when considering whether to participate in a clinical trial, it also provides information about trials that are looking for patient volunteers.  Right now, their are dozens of clinical trials that are in need of patient volunteers.  Without volunteers, these trials cannot begin and their would be no way to test the effectiveness and safety of potential new treatments.  Industry has helped underwrite some of the costs to provide this service to our patient constituents.  

In addition, for the past several years the Foundation has been conducting a study of data from past lupus clinical trials to better understand the impact of background therapies on trial outcomes.  These background medications, the drugs that patients are on when they enter a clinical, have masked the effect of the study medication, skewing the results of trials of potential new treatments and in many cases prevented the trials from reaching their primary endpoints, thus failing to obtain FDA approval.  Industry has been helping to support these studies.  You can read more about this effort on our website

Also, the Foundation leads a coalition of more than 50 nonprofit health organizations that are working in other chronic disease areas to address issues with the Medicare Part D prescription drug benefit.  This effort is to ensure that people with lupus and other chronic conditions have access to all of the medications that their doctor prescribes and that access is not arbitrarily removed by omitting certain medications on approved formulary lists offered by health insurance providers.  Again, industry helps to support this effort.  

The Foundation also supports a global coalition of lupus groups, the World Lupus Federation.  There are approximately 180 lupus groups around the world and the LFA leads the World Lupus Federation to advance the capacity of lupus groups to serve their constituents, provide services, raise awareness and advocate on behalf of people with lupus in their countries.  Industry provides some of the funding to support the activities of the Federation.  

Industry also partners with the Foundation to conduct research.  For example, industry helped to support the Foundation's efforts to conduct a global patient needs assessment that identified and prioritized patient information and service needs.  We have partnered on a number of patient needs assessments and the data from several of these studies have been presented at major scientific conferences and shared with clinicians and scientists working in the field.

The Foundation also has a industry council that identifies and addresses scientific and regulatory issues that are standing in the way of development and approval of new treatments for lupus.  For example, the Foundation is working with officials of the U.S. Food and Drug Administration to develop new designs for clinical trials that would enable trials to be smaller and shorter in duration so more compounds can be tested without significant delay or expense.  This effort can help stimulate more biotechnology companies, that often do not have the resources to conduct large trials required for lupus, to enter the field of lupus drug development.  Right now, trials of potential lupus drugs must be very large and can last years to go through all of the required phases necessary to meet current regulatory requirements.  

The Foundation has a very strict policy regarding the independence of any program or activity that receives industry support.  For example, we don't allow industry members to sit on our board, or serve on program committees, so they cannot influence policy, program agendas or strategic priorities. We also have in place an industry disclosure policy that requires the Foundation to publish industry donations of $5000 or more on our website.  The Foundation has been very open and transparent of its industry support.  

As you can learn from everything listed above, Industry is an important partner with the Foundation in advancing lupus drug development.  Creating an arsenal of new treatments for lupus is one of the Foundation's most important strategic outcomes. Patients and their doctors will need a number of different therapies to treat all of the many manifestations of this diverse and complex disease.  

While advancing lupus drug development is an important priority of the Foundation, support from industry represents only a very small portion of our very diverse revenue streams needed to conduct our programs of research, education and advocacy.  Our focus has always been on serving the needs of the patients.  In fact, the LFA is part of an effort this fall to conduct a public meeting with the FDA as part of its patient-focused drug development program.  This event will ensure that the patient voice is heard loudly and clearly by policy makers and other FDA officials regarding the needs and priorities of lupus patients for development of new safe, effective and tolerable therapies for this disease.

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taffylinden

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Thank you much for the information. 
Robinj

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It would be nice to think that if a non-pharmaceutical treatment showed promise, the LFA would support it. My guess is that it is unlikely given the huge profit that would be lost. I get that to a degree., we need to pay those big salaries. But, show me where the LFA took the time and/or cash-ola to research things like UVA1.......
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Sky

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Lupuscommunity?
Thanks for the information. My concern is the "new instrument that would be more sensitive to the changes in disease activity. And you mentioning that "while advancing lupus Drug development is an important priority...my question is related to genetic testing. As we know lupus can be difficult to diagnose. There are so many autoimmune diseases out there and it concerns me that some are dx with lupus and put on medications that they may not need or dx is not quite confirmed. And there goes the circle, one pill may help but then you have side effects so your prescribed another pill and on and on
I have not entered into any clinical trials and I don't know that much about them To risky for me and I don't want to be either on a placebo versus a drug. Blind study. There are lupus patients who can benefit from this and are willing to try it. They are the hero's. Not only are they trying to get better but helping in the research of this horrible disease for others
My question is; what is the cost of genetic testing versus the pharmaceutical companies? Pharmaceuticals have control over us and are filling their pockets or should I say their banks. . Since some patients are struggling to get some answers to their symptoms, should it not be put on the table to push this as well? Would that be cheaper?
And with genetic testing, you have a definitive answer. But then there's the medical insurance and I'll leave it at that.
Thanks again
lupuscommunity

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>>> It would be nice to think that if a non-pharmaceutical treatment showed promise, the LFA would support it. My guess is that it is unlikely given the huge profit that would be lost. I get that to a degree., we need to pay those big salaries. But, show me where the LFA took the time and/or cash-ola to research things like UVA1....... <<<

Robyn,

When there is more than anecdotal evidence that non-phamra treatments are safe and effective, then perhaps you might see more information on those alternatives.  But the evidence is just not there.  There has to be a documented scientific opportunity and an identified pathway before investigators are going to invest time and institutions invest money in that area.  All of the studies that Anthony et al provided were mostly a decade old with very mixed results that did not offer too much incentive to continue down those pathways.  

Phama has invested millions if not billions of dollars in developing new safe and effective and more tolerable treatments for lupus and thus far only one drug has managed to make it through to approval.  Lupus is a very complex disease, and many investigators now believe lupus is not one disease but a spectrum of similar diseases.   One drug or one therapeutic option is not going to be sufficient for managing a disease that is this diverse and complicated.   There are dozens of clinical trials underway, most still looking for patient volunteers. Getting these trials fully enrolled and underway will greatly advance the opportunity to people with lupus to have better and more tolerable treatments that can bring the disease under control and provide for a better quality of life.   

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Robinj

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All of the studies that Anthony et al provided were mostly a decade old with very mixed results that did not offer too much incentive to continue down those pathways.  

Incentive=profit???

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lupuscommunity

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>>>what is the cost of genetic testing versus the pharmaceutical companies? Pharmaceuticals have control over us and are filling their pockets or should I say their banks. . Since some patients are struggling to get some answers to their symptoms, should it not be put on the table to push this as well? Would that be cheaper?  
And with genetic testing, you have a definitive answer. But then there's the medical insurance and I'll leave it at that. <<

Sky,

The cause of lupus is not fully understood.  We believe lupus has an underlying basis and that other factors such as environmental factors and hormones are also involved.  There  have been many genes identified that may play a role in lupus but none have been confirmed for having a definite relationship to the disease.  And there is still no specific genetic testing available.  

What you are referring to is customized medicine, where the therapy can be selected based on the genetic make up of the patient.  This procedure is beginning to be employed in other diseases.  But lupus is not a single gene condition.  There may be many genes involved in lupus and in many different combinations.  Researchers are working toward that outcome where therapies can be tailored to the patient but that opportunity is still a long way off, given the genetic complexity of lupus. 

In order to factor out the well-documented 'placebo effect' clinical trials are double-blinded, meaning neither the patient nor the doctor know which trial participant is receiving the study medication and which is receiving placebo.   However, no patients are taken off their normal background medications, the therapies that they are on when they enter the study.  In lupus trials, the patients will continue to receive their medications.  Some will also receive a dose of the study medications added to their regular therapies, and others will also receive an inactive agent (placebo) added to their regular therapies.  

The role of these 'background therapies' as we call them, the medications that patients are on when they enter the study, is one of the reasons that lupus clinical trials have to be so large, and so long.  Because the background medications, often steroids or immunosuppressant agents, are effective in controlling the disease in most patients.  But that also makes it much harder to show the effect of the study medications.    That has been a problem in many of the past clinical trials that have failed over the past 20+ years with previous experimental therapies for lupus.  It's not that the drugs may not have worked, it's that the trial sponsors couldn't prove that they were working better than the background meds, even though the experimental medication may have been much safer, more tolerable with less toxicity.  There have been many 'failed' trials of agents that didn't reach their primary endpoints.  If industry keeps running into dead ends they may opt not to invest the millions of dollars required to develop new safer and tolerable treatments for lupus, considering it too risky of an investment for what is a rather small market, compared to other conditions that might have tens of millions of potential patients.  It would be nice to believe that pharma is altruistic and will invest in lupus simply because it's an unmet need.  But the reality is that stockholders demand a reasonable return.  And if you want to have better medicines, industry must see a pathway forward. 

This is the reason that the Lupus Foundation of America has focused on identifying and overcoming 
the critical barriers to developing and testing new therapies for lupus.  As noted previously, one therapy will never be enough for this diverse disease.  So we have embarked on a comprehensive effort to advance the development of new treatments for lupus.  These initiatives seek to address the barriers, beginning with commissioning a study that identified the barriers and developed a pathway forward.  The Lewin Report was the first comprehensive assessment of lupus drug development issues that provided a roadmap to advance lupus clinical research.  The Foundation has been investing in implementing these recommendations since the report was issued in 2009. 

That is the reason we invested in the Collective Data Analysis Initiative to understand the role that the background medications are having on the outcomes of lupus clinical trials, and developing a new instrument that will be more sensitive in measuring disease activity and the effects of treatment.  We also worked with investigators worldwide to develop the first accepted definition of a lupus flare.  Up to this point, there was no agreement on what actually was considered a flare for use in a clinical trial, where 'time to flare' and 'number and severity of flares, were primary or secondary endpoints.  We also are working with the FDA to find alternatives to the way lupus clinical trials are presently conducted so they can be smaller, shorter, and with less background medications.  All of these initiatives are designed to speed development of new treatments for lupus.  Nobody was doing this work previously.  If these barriers were left to remain, all the research in the world would not have resulted in better treatments for lupus because there would be no way to get them through the regulatory and approval process.  

I guess we could opt to invest solely in basic research and identify still one more gene believed to be responsible for lupus.  But that would not advance the ball very quickly.  Our approach to research has been to focus on the areas that will have the greatest, most immediate impact on developing new treatments for lupus that will help patients improve their quality of life.  

Our research effort is multidimensional with direct funding of investigators, scientific initiatives led by the Foundation, and advocacy efforts to stimulate millions of dollars in federal funding for research as well as changes to regulations and public policies that advance lupus research and treatment. We are very proud of our accomplishments which have had a profound impact over our past 40 years on the field.  



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Sky

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Lupuscommunity, i understand the frustration with your argument with non-pharmaceuticals not being safe and effective. But, what's being done to investigate or has been done in randomized studies with UVA-1 versus a "drug"? Why is that when you see people who are trying to get a dx for years and they are not getting a true dx. The physicians sometimes put a stamp on their forehead and a script for a drug. What are the alternative medicines that you have addressed at the table. If lupus is not just one disease but a spectrum of similar diseases as you mentioned; Then I would suggest that you fight for genetic testing. Wouldn't that solve this mysterious disease. And treat the patient per their dx. I can only hope that you fight for genetic testing. Get the message to the physicians, board members etc. Its nothing new in past history; that me and others have been struggling to get a dx, get the correct treatment and have confidence in knowing what their dx is. It's our bodies and for me, I really want to know what is my genetic makeup so I can share this with my family members and for future generations in my family. And for my very close cousins who have passed away from kidney failure and possible Lupus/autoimmune disease, etc. Hope you will take this advice as well as the others on this message board.
I've had lupus nephritis per biopsy for 35-years; without going into details I can only express the frustration I'm dealing with now. Per U of M rheumatologist, he does not think I have lupus and is going to contact the professor who is ahead of the lupus "clinic" to see if I can get genetic testing. This is the second time around for me. I went to U of M approximately 16-years ago and had mixed diagnoses. But the rheumatologists I've seen in my area and am currently seeing are treating me for Lupus. Please fight for genetic testing and please fight for alternative medicines when appropriate per dx.
Cakelady

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The problem I see with generic testing is to many people will get the dx of lupus. Lupus is not a dx you want. We have a lot of people who come on this forum and say if I am dx with lupus then I get SSDI right ? And that's not the message that we or I want to send.

People with lupus can work can go on vacation etc. you just need to do things differently.


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Cakelady

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Oh one last thing our moderator DOES fight for us. He fights for better treatment, more funding, getting the message out about lupus and he fights for this forum.
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Sky

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I'm sure the moderators work hard behind the scenes. Yes to get the word out, more funding and so much more. I'm sure it's a tough job to be on the forefront.
Sky

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Lupuscommunity, I just read your feedback addressed to me. Thank you for taking the time to do so. I'm sure it is not easy to get your voice out there and to be taken seriously. And, I thank you for your role in speaking out for Lupus/autoimmune diseases. As well focusing on having the greatest and immediate impact in improving patients quality of life. I get the statement that there are many genes that play a role in identifying the role of Lupus. I still think money needs to be spent on more research regarding genetic testing regardless of how many genes are identified. I would want to know what's going on with my body, what on the carriers I have. Why my body is reacting this way and etcetera. . The only thing I've heard/read for a some time is that the possible causes of Lupus are Environmental and hormone factors.
It takes time and much more research to continue this fight. It's all politics and who can benefit. Not just with Lupus but with many other diseases.

taffylinden

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It's so good to see this dialogue happening. I think it's badly needed.

I'm confused about one thing, however, that seems like a catch-22: we won't see more interest in nontraditional treatments because there's only anecdotal evidence, yet there's little interest and therefore little funding for conducting double-blind wide-scale clinical trials. 

Lupus patients are especially vulnerable to every nontraditional remedy out there because lupus is a disease that flares and improves, so if Patient A reads on online about the wonders of Herb X and tries it and her symptoms improve, she's likely to ascribe it to Herb X instead of realizing the flare was ending then anyway--or that it's simply the placebo effect. Big Herba has no incentive to do clinical trials because desperate people buy their products anyway. Big Pharma has no incentive because those substances are already available OTC, so no profit awaits.

The UVA1 situation was/is similar. 

So how would we EVER know with certainty whether nontrad treatments work? With relatively few treatment options available, and with so little known about lupus itself, seems to me like an important question.
Cakelady

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I kinda think it's up to the patient and their doctors. I have been having real bad migraines to the point I can't move. My neurologist hesitanted to put me on more meds so we are trying vitemins and migraine meds when they get really bad.
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