The Double Edged Sword
Or you may want to use the metaphor of the apple of the tree of knowledge. Whatever metaphor you use, knowledge can be wonderful, liberating, life saving and search for knowledge is the best part of the human spirit. Search for knowledge can also be devastating, destructive, and in the wrong hands it can be downright criminal.
Clinical Trials and the Search for Answers
I am a big fan of clinical trials – well thought out, well conducted and ethical clinical trials. Without clinical trials and their hard won knowledge, we will never be able to change the word “incurable” in front of CLL.
Sometimes our members get all excited about some breathless “miracle of the month” story in the lay-press, talking about how “leukemia” (which one? There are dozens of different leukemias, each of them distinct and needing different therapy approaches) is now cured – in the lab test tube. Typically, this is how the story goes: some CLL cells in a glass dish are treated with the new miracle drug candidate and the cells died. Heck, I can do that with mouthwash! The alcohol in it would kill most cells, including CLL cells. But no one would seriously consider mouthwash is a cure for CLL. The amount of time it takes to go from the “Aha!!” moment in a lab test to a clinically viable therapy option that patients can use to live longer and healthier lives can be 10 years or more – if everything goes exactly right.
How many “Aha!!” moments make it all the way? Less than a fraction of 1%. Somewhere along the line, as the research goes from glassware experiments through mice and other animals and finally to human clinical trials, the “miracle” generally loses its shine. Adverse effects start showing up, sometimes they are so many or so dangerous that research with the concept drug comes to a grinding halt. Sometimes, the drug that killed CLL cells in such large numbers in the lab does very little when injected into the human body. Sometimes money runs out before the drug can be completely tested and its sponsors walk away. And sometimes, more often than you would think, the human studies go no where fast because recruitment of volunteers becomes a huge hurdle. Time is money. The longer it takes to recruit patients, the more the study will cost.
Not all Clinical Trials are Created Equal
Everyone talks about the need for clinical trials, how we need them. There are a couple of vocal patients out there that want better patient participation in clinical trials, all clinical trials. That is almost a motherhood and apple-pie statement. But I strongly believe a few well chosen caveats are in order. We need well-researched, well-designed clinical trials. We need clinical trials that are run to increase understanding of this disease and thereby find potential therapies (dare I say CURE?) for CLL. We need clinical trials whose designs take patient safety and quality of life into account. And above all, we need clinical trials that pay attention to the concept of “informed consent” – the spirit of it and not just legal wording to protect the researcher and his institution from lawsuits.
It saddens me that so many clinical trials are done with an eye on corporate profits rather than patient welfare. Consider trial design where patients are randomized into two groups, one group gets the experimental drug, the other group (the “control group”) gets conventional therapy. If the group that got the experimental drug does better than the control group, the new drug is welcomed as an addition to our available therapy choices. This is the “gold standard” of clinical trial design, two well matched groups of patients randomized into the experimental and control groups in order to eliminate researcher bias, one-on-one comparison where we hope to get clear answers. And if the groups are sufficiently large, the answers we get will be statistically significant.
Aha. But the devil is in the details my friends. Very few large scale and double arm, randomized studies are done anymore, they cost too much money. Most often, research institutions do single arm studies where everyone gets the experimental drug and the results are then compared against historical norms. Sounds good, right?
Only problem is human bias and human nature. Ever heard of cherry-picking? CLL lends itself particularly well to flawed results on account of researchers gilding the lily. If you pick subtly biased group of patients for your single arm study, patients with just slightly better than average prognostic indicators, slightly better overall health, just a tad younger, just a tad less entrenched disease than “historical norms”, who can tell the difference? In an apples to carrots comparison, how can we tell the difference between different therapy options? Several of you asked about FCR statistics, why they are so different in the various studies we reported in our recent articles. Fortunately, there have been enough studies (some of them well conducted double arm studies) that we can feel comfortable about the overall perspective of FCR therapy – even if we don’t quite buy the hyped up statistics in some of the trials. Even with all the caveats, all the warts that we wish were not there, we are lucky to have had this research done. FCR is a very powerful drug combination and there is emerging consensus that CLL patients will live longer in future because of it.
Many things contribute to faulty results and fake conclusions: researcher bias; cherry-picking of trial participants. small scale studies that are almost anecdotal and without statistical significance; subset analysis (where the researchers look at smaller subsets of people in their study, looking until they find the result that ‘proves’ their theory); out and out fraud where companies / researchers deep-six results they do not like or want and publicize selected results that help their profits or careers.
Apples to Carrots Comparisons
A recent clinical trial of Treanda (bendamustine) has been discussed on this site and elsewhere. This was a two arm trial. The results of this trial were pivotal in getting Treanda FDA approval as a CLL drug. Here is my problem with this trial in a nutshell. One group of patients got Treanda. The control group got less than optimum therapy with chlorambucil. Tada! To no one’s surprise, this straw-man comparison showed Treanda worked better than a sub-par regimen of chlorambucil. Don’t get me wrong. Treanda is another drug that works in CLL and I am glad to have more options available to our patients. But this particular trial obeyed the letter of the law and flouted the spirit of it to a large degree.
How would you like to have been one of the volunteers for this trial, randomized to the straw-man control group? What did it cost the patients in terms of time, window of opportunity and unnecessary toxicity without sufficient benefit to be in this control group? Would you say they were suckered in order to make Treanda look good? I am just asking. And I am not the only one. Several well known and respected CLL experts felt uncomfortable about this trial. One or two of them would even acknowledge it in public. It is hard to get these guys to go on the record. Who wants to rock the boat?
The Bigger Picture
Each and every time an individual patient considers participation in a clinical trial, there is a chance for altruism, optimism, greatness – or unfair tactics. Patient consent forms are written by researchers, but overseen by lawyers whose only aim is to protect the researcher and institution from getting sued – that is the sad truth of it. Internal ethics and oversight committees are staffed by research and industry folks – none of whom are particularly interested in totaling their careers by rocking the boat. The few “patient advocates” on these boards often have no science background, totally blown away by the jargon and intimidated into being little more than rubber stamps. True, there are some stellar exceptions to this and I salute them.
But by and large, there are valid reasons why patients are not volunteering in droves to participate in clinical trials. The system is broken; it does not play fair; there are too many vested interests; too much money controlling the results to the detriment of good science; last but by no means least, it does not really respect patients and their rights. I really mean that word, RESPECT. Few clinical trial designs truly consider the individual patient being recruited, that he is not just a number in a data base, he is an individuals with a life to live, family that loves him and depends on him. A while ago a large drug company asked my help in understanding why their clinical trial had so much trouble recruiting patients. Besides the obvious toxicity of their very immune suppressive drug combination, the company failed to see that patients are not lab rats, they would not want to be subjected to a bone marrow biopsy after each cycle of therapy. The researchers thought the data would be nice to have – the patients rightly thought otherwise.
The Bad Old Days
So, what caused me to have this particular brain melt-down on the whole business of medical research, why we need it so desperately and what can go terribly wrong with it? Below is a link to a news story that you should read in full, I have a few quotes from it for your convenience. The incidents it reports happened in the lifetime of most of our patients. It happened after the World War II and the well documented atrocities of the Nazi medical experiments on helpless victims in concentration camps. This story is not about war, not about concentration camps. It is about doctors that truly forgot their oath to do no harm. It is about one group of people treating another group of people as less than human, as so much garbage to be abused in any fashion they chose. And who was the perpetrator of this inhuman medical atrocity? The American medical establishment.
Those were the bad old days. I am pretty sure such horrific experiments are not conducted anymore, and I most sincerely hope my tax dollars do not pay for such things. Now we need to worry about more subtle nuances. When is informed consent truly informed? When does it become a crime to recruit patients without disclosing all the facts and conflicts of interest, or gloss them over with a wink and a nod? Or buried under deliberately confusing jargon? When does the profit motive totally overwhelm good science? When are our voices heard, when do our advocates get a seat at the table where decisions are made? When do we get the respect we deserve, as we put our lives on the line and participate in clinical trials?
It is a hard road to travel. But travel it we must, with our eyes wide open. Do it for the fat lady.
U.S. Apologizes for Syphilis Experiment in Guatemala
By DONALD G. McNEIL Jr.
October 1, 2010, New York Times.
From 1946 to 1948, American public health doctors deliberately infected nearly 700 Guatemalans — prison inmates, mental patients and soldiers — with venereal diseases in what was meant as an effort to test the effectiveness of penicillin. American tax dollars, through the National Institutes of Health, even paid for syphilis-infected prostitutes to sleep with prisoners, since Guatemalan prisons allowed such visits. When the prostitutes did not succeed in infecting the men, some prisoners had the bacteria poured onto scrapes made on their penises, faces or arms, and in some cases it was injected by spinal puncture.
If the subjects contracted the disease, they were given antibiotics. “However, whether everyone was then cured is not clear,” said Susan M. Reverby, the professor at Wellesley College who brought the experiments to light in a research paper that prompted American health officials to investigate.
The revelations were made public on Friday, when Secretary of State Hillary Rodham Clinton and Health and Human Services Secretary Kathleen Sebelius apologized to the government of Guatemala and the survivors and descendants of those infected. They called the experiments “clearly unethical.”
In a twist to the revelation, the public health doctor who led the experiment, John C. Cutler, would later have an important role in the Tuskegee study in which black American men with syphilis were deliberately left untreated for decades. Late in his own life, Dr. Cutler continued to defend the Tuskegee work. In 1972, it was revealed that, even when early antibiotics were invented, doctors hid that fact from the men in order to keep studying them. Dr. Cutler, who died in 2003, defended the Tuskegee experiment in a 1993 documentary.
The Nuremberg trials of Nazi doctors who experimented on concentration camp inmates and prisoners led to a code of ethics, though it had no force of law. In the 1964 Helsinki Declaration, the medical associations of many countries adopted a code. The Tuskegee scandal and the hearings into it conducted by Senator Edward M. Kennedy became the basis for the 1981 American laws governing research on human subjects. It was preceded by other domestic scandals. From 1963 to 1966, researchers at the Willowbrook State School on Staten Island infected retarded children with hepatitis to test gamma globulin against it. And in 1963, elderly patients at the Brooklyn Jewish Chronic Disease Hospital were injected with live cancer cells to see if they caused tumors.
33 comments on "Clinical Trials and the “Bad Old Days”"
Dr. Mengele would be proud.
Very interesting, insightful, and thought provoking article. Thank you. Mark
Morning, Chaya…
Haven’t commented in awhile, but my first thought is how your above comments would apply to the EGCG trial at Mayo clinic that Drs. Kay and Shanafelt are involved in?
And, as long as I’m on the topic, how is phase three of that study coming? Still on target? I read that phase two showed that 69% of the participants exhibited a biological response producing at least a 20% reduction in lymphocyte count.
(www.mayoclinic.org/news2010-rst/5833.html)
Harley
The green tea EGCG trial was a very interesting case study. It is still a unique experiment in how an active patient community can drive research that benefits them.
Based on many population based studies that suggested green tea extracts may have anti-cancer properties, there was a lot of interest in the patient community. Does it work or is it yet another old wives’ tale that falls apart on close scrutiny? We knew only a credible and well conducted clinical trial would answer the questions.
Back then CLL Topics was a non-profit organization. PC and I were in the early years of our fight against CLL, full of optimism and energy. We knew that it was going to be next to impossible to get any big drug company interested in this trial. Even if they proved the point and green tea extracts were valuable anti-cancer medication, what would they gain? Patients can then turn around and buy the stuff from their supermarket or health food stores. It is not possible to patent and control green tea or its extracts.
To my lasting admiration, Dr. Neil Kay of Mayo Clinic in ROchester MN responded to our email query – one of a very few CLL experts that did. He and Mayo took us seriously. We raised $70,000 – no small sum – from patient donations. Many of these were $10 or $20 donations from people setting aside the money from their Social security checks. Mayo got some financial help from the NCI, as well as some internal funds and the trial was launched.
So far, they have completed modest size Phase II trial that proves the concept. We wrote about the results extensively on http://www.clltopics.org and I will not go into it again here. I advise you to look them up if you are interested. Just type EGCG or green tea in the search box at the top right hand corner.
Green tea extract does not cure CLL. But its extract EGCG does seem to help a percentage of the CLL population keep the disease at bay, reduce the rate of progression. The side effects were marginal (stomach upset, especially if taken at high dose and on an empty stomach; liver issues at very high doses. Possible reduction in platelet counts in some patients) and reversible by the simple act of stopping the supplement.
Where do we go from here? Mayo needs to do a larger scale Phase III trial to nail down these results. Large scale phase III trials cost money. Also unfortunately the manufacturer of the high purity pharamceutical grade EGCG that Mayo used in their study is no longer interested in making the stuff. Road blocks. Life sucks.
Before anyone asks me, let me be upfront about our situation. CLL Topics is no longer a non-profit organization. The amount of paperwork and organization needed to run a squeaky clean non-profit is quite a bit. PC was good at that sort of thing. It is not in my skill set. With him gone, our staffing has decreased by 50%. Running a non-profit, raising money for clinical trial is no longer something I can do.
Will anyone else take up this crusade, get the money together and fund the Phase III clinical trial? I hope so. It is a bit more complex than just writing a check for a couple of thousand dollars. We are talking of a hundred or more thousands of dollars. We are talking of an organization that can take responsibility for overseeing the project, making sure patients’ interests are not forgotten in the process. I have learned a long time ago that it does not work to just throw money at a problem without spending the human effort of managing the process.
I wish I still had that early fire in the belly when no job was too big, no project too difficult and “no” was not a word in my vocabulary. PC is gone, this ship runs at half mast, now and forever. I sometimes wonder if I should retire gracefully – make room for new faces and new ideas, new advocates that bring more optimism and energy to the debate.
Is there an advisory board for CLL topics? I still think you have alot of fire left in your belly because you probably stared out with more than most of us .To use the term from Ayurveda, the system of medicine that began in your country of origen, I have a feeling you started out with more “agni” (fire) in your belly.
Well written and provovative report you shared. Thank you
Nancy Moran
Tulsa
Thank you Chaya
Your article is so true. As I went through my trial, and just after the first chemo treatment had shortness of breath, and was in the hospital for a week with everyone trying to figure out why. No one thought about the chemo, and it was not on any of the drugs side effects sheets that were a part of the informed consent. Yet, finally four years after the chemo, they admitted that it was a side effect of the drugs. It is a continual problem, and one that needs to be determined prior to my next protocol.
The issue was that they never put my problems with the protocol into their review of the chemo trial. It should have been there.
Keep up the good work,
Anne
Chaya,
Articulate, accurate and informative as usual. My dear, you will always have fire in the belly.
Re: green tea. My story. I was drinking a substantial amount of green tea when I was diagnosed with CLL over 16 years ago.
Blessings,
Rita
I totally understand your statement about new faces, new ideas, more optimism. Sometimes CLL can beat one down after years of looking for the cure. I seem to be seeing that line in myself also. Sigh. As you know, Tom is a trial rat at MDAnderson. We are now going for QOL. He is on the Phase I Btk inhibitor trial that he started last week. So far, really good stuff seen as his nodes melt away without the horrible fatigue, rash, etc. of Revlimid.
Stay hopeful and I will do the same.
JLOU
I had a friend with a slow lung cancer. She was in her late 70’s (not a spring chicken) and I gave her the run down on phases of clinical trials. Phase one is for toxicity and who wants to be in that one with really toxic drugs at that age. She lived about 7 years with lung cancer and NOT the most toxic drugs.
Maybe I have a bias against drug companies but are they really interested in the patient or profits?
When I consider statistics, I am always reminded about what Ralph Moss said about them. That in the hospital where he worked, they actually rolled people out to the hallway from intensive care when they were going to die so statistically they DID NOT DIE in ICU.
Chaya here is a question and I know it is a cynical one that I always wanted to ask. Medicine applauds 2 months of extended life but at what price? Are they extending life or death? I have serious trust issues with big pharm.
Who would tell us the unvarnished truth if you were to retire?
I’ve been all over the web for years and years and this is the only website that thoroughly, honestly & unpatronizingly explains in plain English the benefits and disadvantages of various treatments, and always, always, always with an eye toward the quality of life of each and every CLL patient.
You have the heart of a lion (or mamma grizzly) and the soul of a warrior, in addition to a fine mind. You are irreplaceable. You can’t leave now, Chaya.
We have all been created for a purpose that may or may not be clear to us until we’ve passed to the “other side”. Your life obviously has meaning to your biological family. Additionally, you’ve “adopted” this huge extended cll family. While offering wise counsel to us, you’re surely keeping a heck of a lot of hematologists on their toes as well.
Chaya,
Your exhaustion is understandable; your long-standing dedication is remarkable. So many of us depend on you. How can we support you, who have given us so much support, so you can continue without feeling overburdened? Is there a way, within the present (not-nonprofit) structure of CLL Topics, for us to organize a fund-raising campaign for EGCG Phase III trial? I don’t understand the legal issues of that. Could some of us help relieve the burden? Nancy asks about an advisory board. What about that? and/or a group to publicize the patient-funded trials and promising results, to raise money to take it to the next stage?
Thank you Chaya,for a very informative article.
Stay well,
Monique
Chaya — I think there is NO One out there that can take your place – You have become a friend as well as an advisor over the years. Someone that is respected throughout the medical community.
Let us known what we can do as your friends to lesson the burden. Since this is no longer a non-profit organization – you need to let us know what you need financially to keep the fire going – (besides your willing heart to help us) Maybe a finacial ‘goal’ that lets us known how the donations are doing? We donate but then perhaps stop, thinking you have reached what you need. We all have to pull together to keep the information flowing –
Besides, you would be bored without us ………..wouldn’t you? ~~~~
Darlene
Chaya:
You still are an amazing, valuable resource/advocate, but like you tell us, you too need to take care of yourself and do the things you enjoy and make you happy.
As a recent member of the CLL club, your site(s) has provided me with the information necessary to become an informed patient. The fact that you answered my e-mails and offered your personal assistance is even more amazing.
I think Darlene is on target when she asks “Let us know what we can do… to lesson your burden”.
dan
It is amazing what people can rationalize. Did aanyone else see the study on dateline (I think) where scientists told people they needed to give drugs to people up to lethal doses and many people did it with enthusiasm?
In my medical ethics class, taught by a data faking scientist, we were asked who would construct a trial that cured cancer but would result in at least 1 death. Over half the class chose to kill someone to cure cancer. I was appalled and amazed. There is no way a trial should be coducted with a certain death.
The ethics of the NIH have not improved that much in the last 60 years. They only find scientists guilty of misconduct in less than 5% of cases. Given the stigma and danger to someeone’s career in blowing the whistle on corruption, it is impossible to believe 95% of the cases are without merit. The NIH and department of human services which oversees them are run by poltiicians who shuffle in and out with each administration. Even with the best intentions, by the time they realize how the lifetime pencil pushers have manipulated them, it is time to go.
Dear Chaya,
I have been a faithful reader and fan of yours for years. I cannot tell you how much your informed articles have helped me to become a more informed patient. There is still so much to know for the individual patient and such hard decisions to make relative to treatment. I am in my fifth treatment, three traditional and two clinical trials, the latter did nothing for me. I still have hope.
Be well and I hope that you still share your desire to improve the lot of us with CLL/SLL.
Heartfelt thanks.
Murre
Hello Chaya,
I have not commented for a long time, which does not mean that I don’t follow and appreciate your sterling work.
Of course you must think of yourself; however I get a feeling that the advocacy and the CLL Topics Site have become part of your being; and we rely on you to decipher the jargon.
I also send all your articles to the haematologist! Keeps him better informed he says.
Great article, unfortunately only too true. Thanks again.
Mette
Chaya,
Isn’t it amazing the things we sometimes convince ourselves it is acceptable to do to fellow human beings. Actually, I suppose it isn’t amazing. While we often disagree about what causes Sociopaths — Evolution, Environment, Evil — I think most of us agree they exist. So our value systems will occasionally reflect their influence.
On a much brighter note, I thought the NIH did a very thorough job of explaining possible risks involved in any procedures I might encounter in the CLL Natural History study. I realize this study does not fully represent the circumstances of many clinical trials since researchers are not saddled with the additional burden of proving a new drug in this instance.
Thanks & Be Well,
Jim
Great column Chaya. I have been dealing and learning about CLL for 8 years now including participating in one trial. In my humble opinion because of the long chronic nature of CLL and because there are so many variables from patient to patient, a large double arm trial will probably never be properly conducted nor should it. Large double arm trials are great for some diseases but not CLL. In the last 10 years as more prognostic tests (FISH, ZAP70, Hemscan, mutation status, etc) have been developed and have become more accurate and cheaper- the body of historic evidence and norms for individual disease courses is becoming more refined and should offer us accurate historic norms to breakdown and compare single arm trials against. The bean counters at Big Pharma will never invest in the basic research to “cure” CLL; there is more money in Viagra and “restless-leg syndrome” promoted by expensive endless TV commercials. It is the nature of the beast and I accept that. We have to hope venture capitalists backing individual researchers doing small single-arm trials can make breakthroughs and then get bought out & promoted by Big Pharma. The NIH, universities with public & private grant money, philanthropists, and scientists with great integrity are our best hope. There is plenty in the pipeline- lets hope some of it makes it through. My thinking is so stubborn that I don’t have near the faith in FCR for truly improving OS that you and most others do. CLL can be a scary disease with so many unknowns that patients can be easily talked into premature, expensive, ineffective, “standard” treatments with serious side effects and believe they are effectively “fighting” their disease. May god bless all who came before us for participating in trials. Anyway…great column.
Big Dad
Thanks for your excellent articles Chaya.
I am a physician with CLL, now retired. Some comments on clinical trials.
1. I was scheduled to have a fourth experimental agent added to my proposed PCR- similar to FCR, but with Pentostatin. A week before the chemo was scheduled to begin I had pneumonia. The chemo was postponed a month and the trial participation cancelled by the doctor. I guess that is an example of some sort of bias.
2. I just had a cardiac ablation for an arrythmia and participated in a trial, which basically was a new fancy way to burn the inside of the heart where the pulmonary veins enter. So far I am doing OK.
3. The article about the penicillin experiments in Guatemala reek of “I know all the answers” hypocrites. This was the era when the U.S. dropped two A-bombs on Japan to stop a war that had already killed 80 Million people. Before the first antibiotics were discovered infections killed half of children by age 8 and most of the older people. The public health workers who paved the way for all of us -especially those with CLL- to enjoy the miraculous benefits of antibiotics, should be praised and not spat upon. Do you know people who are still alive because of antibiotic research? The doctors who did this work were selfless good guys who lived at a different time. Turning it now into a political circus is selfish.
4. I beleive that patients who particpate in clinical trails are moral, ethical and serve future generations. Those who don’t, may not be.
Be well, DBS
Bigdad:
I cannot disagree with you more strongly. No, these guys were not selfless good guys. They had no right to kill people in the name of science. They were murderers and no different than the Dr. Mengele someone mentioned earlier on. Ends do not justify the means.
Spit on them? I would like to have seen them brought to justice and tried for murder. A patena of science does not give anyone the right to kill and maime others.
I am sort of speechless!!! I hope some of you out there speak up on this point.
MarilynHL above quotes Ralph Moss. I recommend his books on the cancer industry, both classic and CAM. I also bought his specific Binder on CLL, which I find quite useful. It by the strongly recommends this site.
Dr. Moss also happens to be on the advisory board of Life Extension Foundation (LEF). This is an outfit that sells well researched supplements and uses the profits to fund research, including some clinical trials on substances that are not profitable enough for drug companies to conduct. They among many others also sell green tea extracts. Perhaps they are a candidate to help fund the completion of the EGCG trial…along with donations from our “club”. I am optimistic that we could raise $50k here towards this if we had a committee to help add to Chaya’s energy. We would first need a concrete proposal from the people able and willing to conduct the phase 3 trial, including a realistic estimate of the costs.
The last I looked the head of determining funding projects for LEF is a semi-retired oncologist in Ashland OR, a Dr. Jacobs. I have talked to both Dr. Jacobs and Dr. Moss in the past and would be willing to contact them on the EGCG trial if we first had our ducks lined up and Chaya’s leadership a committee that could herd the ducks.
tsvieps:
I am afraid I have no desire to herd ducks, most definitely not if it involves working with the likes of LEF or Ralph Moss.
By the way, LEF makes over the counter supplements – lots and lots of them, many of them of of questionable value in my opinion. They seem to have reasonably good quality control, but the dosages they recommend (of the supplements they sell, of course, at a stiff price) are awfully high and in combination they could be down right dangerous. LEF is not what I would consider a fit partner for a patient group. Too much of a profit motive involved in everything they do, including bending the science if it suits them. If the only data we had regarding green tea extracts was a clinical trial of EGCG sponsored by LEF (using capsules manufactured and sold by LEF, of course), I would be concerned about the credibility of the results.
Of course, people who believe in alternative medical practices would disagree with my take on them. But as our ground rules spell out quite clearly, this website deals with evidence based medicine reported in well regarded professional journals.
I regret to tell you I also do not share your enthusiasm for Ralph Moss. Sensationalized reporting and not always good science. One more “Cancer Guru” making big bucks selling sound bites to scared patients. Sensational reporting sells newsletters, and as some wit once said, there is a sucker born every minute.
You clearly have a different perspective on this and other issues we have discussed in our earlier email exchange – and you are welcome to your opinions. This is a free country. Nothing stops you or anyone else from building your own organization, website, soap-box – whatever – and doing what you think is the right thing to do. I have no illusions about being able to satisfy all the needs of this patient community. I do what I can, but on my terms.
Dear Chaya,
Your ‘terms’ are why we are here and why we need you to battle on for us. We cannot fail to appreciate what this costs you, loss of family time and emotional wear and tear as you try to answer our questions while remaining an irreplaceable source of understandable CLL science.
No one could criticize you for tiring of the burden but know that you have earned respect, gratitude and support for as long as you can continue.
No problem. I like dealing with people who have clear boundaries.
Was just an idea for partial sponsorship with no indication that LEF would even be interested. My thinking was that the same group to did the phase 2 trial would work out the plan for the phase 3 trial and run it. True, I was thinking maybe LEF might be interested in manufacturing the EGCG in the formulation that was in the last trial that the old manufacture no longer wants to supply…also only part of my imagination. Not sure why LEF’s profit motive would be worse than the previous EGCG manufacture…or any other pharm outfit that sponsors a clinical trial on their own drug.
Does not seem, though, like Chaya wants any more discussion here.
On Moss, I do see that his news letters can be self promoting and perhaps he is making big bucks, but I have not noticed sensationalization or scare techniques. Again, Chaya does not seem to be inviting any more discussion here…but, Chaya, if you have the time or inclination, I would welcome an email on some specifics from him that raise red or yellow flags for you. I also would be happy to send you my binder by him on CLL if you have not yet seen one of his reports…seems well documented to me, even if a bit expensive. Like all the other users of this site, I am trying to navigate the safest path possible though waters I did not intend to be in. I may need to sort through contrary advice and may even take a less traveled path, but I cannot afford to be too pig-headed and want to hear and weigh other opinions.
I have no talent or energy to build my own website or whatever and value what you do…even if I sometimes have a different perspective. Please forgive me if I have treaded outside the boundaries you have drawn…this was not my intention. I was trying to be creative about a problem you presented.
Chaya
Wow! first it is amazing that the Guatamala trial even occured with people that think they are so civilized especially after what Hilter did to experiment on humans the way he did and that no one even questioned him but just did it. Like sheep just following one another.
It is good to hear your comments regarding Ralph Moss. I think it is great that you take a stand and inform us like you do. I find it sad when good people sit back and do nothing and let bad things happen to others. I see it in all things in life. Thank you for standing up.
I hate it when people try to get others to do things by promising great things but don’t tell people the truth. Especially, when it is for their profit. How easily we could get involved with people like this promising us the cure when it only means their profit. I call it the witch Drs, even some of these people selling live blood testing and selling their name brand herbal remedies. Buyer be ware!!!!!
I am in utter shock to BigDad’s remarks — especially since they were coming from a retired physician. The Hippocratic Oath was shredded and spat upon in the experimentation on the prisoners and patients in Guatamala and on the poor black men in Tuskegee.
Excerpt from the Original Hippocratic Oath: “I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone.”
Excerpt from Classic Hippocratic Oath: “I will apply dietic measures for the benefit of the sick according to my ability and judgment; I will keep them from harm and injustice.”
Excerpt from Declaration of Geneva: “I will practice my profession with conscience and dignity;
The health and life of my patient will be my first consideration”
What those researchers did in Guatamala, Tuskegee and the other institutions was unethical and deplorable. Human experimentation without consent and then failure to treat the horrific medical conditions created was barbaric. Not ifs, ands or buts. There’s no way to defend those researchers’ actions. Period.
A clinical trial HAS to be conducted with total informed consent. We, as patients, are often willing to participate in trials because we are hoping to be part of the cure. But we certainly don’t deserve to be duped into the receiving end of a trial that is conducted with less than scrupulous treatment design and consent forms that make the legalease paperwork for mortgages look like kindgarten reading. Because we’re often putting our lives on the line, we deserve respect and honesty. If that respect and honesty isn’t there, I’m afraid that researchers are going to find it even more difficult to find volunteers for their trials.
Madmurphy:
Thanks for your comment. Lack of consent in human trials makes it a crime, murder if the patient dies. Coerced consent or consent obtained by tricking the patient is not much better either.
But when it is truly informed consent, then it is something that I can applaud with all my heart.
We all want to see a cure for what ails us, whether it is CLL or something else. But is it really worth extending our own lives if the information was obtained at the expense of murder of hundreds of other human beings? What else can you call these so-called medical experiments?
All of us will die some day – that is a fact of life. Perhaps it is worth remembering that how we live the time we do have on this earth is just as important as how long we live. Some lines cannot / must not be crossed, no matter what it costs. Human experimentation without consent is one such line.
Dear Mocha,
Chaya said she is not a fan of Ralph Moss. This is her site and out of respect for her I have no intention of debating her conclusion, even if I found his information useful to me. However you have come out with what seems like very serious assault on his character, saying in effect that he lies for profit and promises false cures. I cannot let this stand unchallenged. It is not clear to me that you have any 1st hand knowledge of what he does. Not only does he not offer false cures, he offers no medical advice whatsoever. He does sell reports on work that researchers are doing all over the world and lists reference papers. His report on CLL includes much of what is also available on this site, what clinical trials are in progress, etc. He also reports on what is called CAM and what science is behind it and when he finds little behind it. Chaya does not want this site to discuss CAM. So be it. She also said she does not put much trust in his conclusions and that she thinks he sensationalizes his books to sell more. She respectfully allows that I can have a different perspective. I ask you not to make caustic accusations about anyone unless you have clear evidence to back it up. If you do please send it to me via Chaya. If not, you are guilty of public malicious gossip…a very serious thing. Not at all the same as saying you do not like his books…thats fair game.
Mocha, tsvieps:
Please take this discussion offline. This topic is closed. Send me a personal email if you are interested in contacting each other and I will be happy to make the introductions. You are both grown-ups.
Once again for the record, this site caters to people interested in evidence based mainstream medicine – published in credible journals and preferably peer reviewed.
I have been a scientist all my life. It is only honest to admit my personal bias, part of my personality as well as my educational training. I believe in sticking to what I know best. I have neither interest or any real understanding of CAM or what drives peoples’ interest in it. I will stay the heck away from it for all of those reasons.
But advocating for patients’ rights means exactly that. Your rights. Your right to read what you want to, learn as much as you want to, make the decisions that are right for you. I don’t believe in CAM, I am all for evidence based and rational mainstream medicine, But I will defend your right to make your own healthcare decisions. That is your right and your prerogative and I fully support that.
My father considered himself a very cool and westernized man, a new convert to the concept of equal rights for women. My mom is quiet, long-suffering. I remember my dad yelling at my mom, scolding her and threatening to give her hell unless she too embraced feminism. It sort of defeated the whole point I thought, even back then. My best advice to all of you, take the time to learn and make the decisions that are right for you, then never put yourself through the hell of post purchase regrets.
“Updates” is a labor of love for me and my family. I will not let this site be used to proselytize opinions that I cannot support, or glowing testimonials of individuals and organizations that spread clearly profit motivated and subverted science. If that is your gig, do it in your own space and on your own dime. Fair enough?
I think I have been misunderstood. Did not mean as it was taken sorry. Many times emails are misunderstood and obviously I was or did not come clear. I totally agree with you and everything you said.
Chaya,
I sincerely want to thank you for all that you do and have done for our CLL community. Thank you for being a constant advocate for us. Thank you for being a voice of reason in this sea of confusion and uncertainty, a glimmering light that shines in the darkness. Thank you for your hard work, your encouragement, your honesty, and your integrity. Thank you for your gracious heart, which we all know has been forever scared by the loss of PC. Though we cannot feel the depths of your own pain, we can all empathize from our own experiences of loss. It is all the more special to us to know that you have fought the battle that we fight and even in the face of your own loss, you have not given up the fight for the rest of us. Thank you for continuing to carry and wave our flag.
Thank you,
Glenn
My english is not so good enough to express myself as I wanted. I would like to say that I am totally agree with Glenn. This site is Superb and help all of us with the most complete and recent information about CLL. We don’t find another disease with such scientific and fully information. We must be gratefully to Chaya for give us her energy,knowledge and intelligence explaining difficult things with a clear and simple language.Chaya owns our admiration,because nevertheless P.C. lost that miss forever, is always with open arms to help, inform and guide us in this battle.Thanks for your courage,honesty and integrity.
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