A Clinical Trial Database On The Internet?
61 CommentsBy Ed Silverman // September 18th, 2007 // 3:05 pm
As the Sept. 21 deadline for renewing PDUFA draws ever closer - and with it, the threat of layoffs of nearly 2,000 FDA employees - the behind-the-scenes squabble over creating a clinical trial database apparently remains unresolved. The White House opposes the House version of the FDA reform bill, because it claims the FDA and NIH wouldn’t be able to validate the accuracy of the trial results posted; results data is too technical, and lay summaries may have too much bias.
The House bill would require a public technical trial results database, as well a lay summary of a drug trials, on the Internet. Negotiations are under way over other issues as well, such as preemption. The White House opposition, however, comes after a stretch in which various drugmakers have been accused of hiding data. The push for the House proposal follows the logic that more information is better than less. But would that be true in this case? What do you think?
Should Garino have disclosed the payments to the patient?
- Yes (91%, 102 Votes)
- No (10%, 11 Votes)
Total Voters: 112
Loading ...
Doug
There is no good reason not to have any information that pertains to the drugs that are out there available to us.
DGHarrison
There is one issue for me that needs to be addressed. If U.S. pharmaceuticals companies release all their drug trial information on the Internet, how does that help or hinder them vis a vis foreign competitors? I hate to think any “trade or process secrets” might be revealed to the competition, allowing them to take advantage by allowing U.S. drugmakers to do all the hard research (i.e., expensive research) just so they can step in and get to the market first. A great deal of industrial intelligence is stolen by foreign agents, and I’d like to make sure that we’re not just handing them information for free.
For those who think this a trivial matter, I want to emphasize that the risk takers deserve to profit from their labors, and that any expectation that profits will not materialize will naturally be met with a void in product development. In other words, if one cannot expect to protect the profits that would cover the cost of the research, that research will likely not be done, and we will not have the new drug at all. So, if you think that the competitors would bring to market a cheaper drug and you don’t care that “Big Pharma” got screwed its competition, think again — there won’t be any such new drug.
Donna
Yes is my answer
C. Lepone
Full disclosure is key. Clinical trial participants agree to become test subjects on an “informed consent” basis. No less should apply to future candidates for those drugs or “therapies”. As more information becomes available, it should be made public in a very broad manner.
Daphne Olson
Definitely and unequivocally YES! So far as the White House’s concerns that the FDA and HIH wouldn’t be able to validate the results posted or that they’d be too technical . . . the public isn’t dumb. We’ve been separating truth from lies in the media for many years . . . and we do have access to technical and medical dictionaries. Believe me, for something this important, we’ll figure it out.
mike creech
In response to DG Harrison. It is a valid point that those who risk should have the reward. There is however no real reason not to post the results once a product has a patent. Once a product is on the open market anyone can do a chem. study and come up with the product, thus the patient.
Now lets consider the benefit beyond the product. If this information is available and indicates a real danger to society. Isn’t it a bit more prudent to prevent a drug release in that situation than to allow mass distribution? After all aren’t we finding now that the pharma has mislead the authorities and public with profit only as the driving force? Then after the harm is done is the real disclosure brought to light.
As valid as profit return on effort matters, we do also need to either have a very ethical pharma or some better control. Based on vote count so far it would appear there is a great deal of agreement. I suspect because of the pharma’s prior un-ethical approach to providing needed or wanted products. Would’nt any sane rational person want to know what the trial results are?
Lori
To DG Harrison -
> Foreign competitors?
To Mike:
> There is however no real reason not to post the results once a product has a patent
Are you kidding? The reality is that there is the small matter of competition between pharmaceutical companies and different products. This information is competitive information. If I can show my drug has a better side effect profile or some other competitive advantage (either using my own my data or my competitors clinical trial) then this is worth $$$$. For good or bad, full information changes the competitive landscape. Take Xyprexa for example.
paula
Yes. Lets take Zyprexa and diabetes.
ZY1 00378054 for example.
Robert W Baker To: Thomas M Broclie/AMJILLY(at)LILLY
10109/2000 03:28 PM cc: Christopher C BombafAM/LLY(at) LILLY, Jack E Jordan/AM/LLY@ Lilly,
Paula T Trzepacz1AM/LLY(at)LILLY
Subject: Re: meeting with endocrinologic consultants
Thanks Tom. I appreciate your generosity with your board’s time Although obviously concerning, it was helpful to see their reaction. My take was that they remained skeptical because of the number of reported adverse events and by the substantial weight increase with olanzapine. Moreover, like this group we believer that definitive research has not yet been done and may not be readily doable. In light of these facts, the finding that olanzapine did not seem worse than haloperidol in terms of inducing hyperglycemia likely appeared counterintuitive, provoking questions about whether methodlology of analysis is hiding real treatment difference. I don’t think that that is the case, but did suggest to the product team members working on analysis that they are fair criticisms that should be addressed. Meanwhile, Chris and I agee that we in the US will benefit by continuing to work with endocrine moving forward.
Best, P
Thomas M Brodie 10/09/2000 03:10 PM
To: Robert W Baker/AM/1+Y(at)Lilly
cc: Eugene H Thiern/AM/LLY(at)LILLY
Subiect: Re: meeting with endocrinologic consultants
Robert clearly, this group of Endocririologists (who spoke up and I would rate those who did speak up as the leaders of the pack) are very concerned with the approach Lilly is taking towards the issue that Zyprexia leads to diabetes. I can only hope that you and all of the team who attended the NADAB meeting are gaining the ear of senior leadership and articulating this finding. Although the boards recommendation is probably not the way Lilly typically does business, I do believe they made a very strong point that
unless we come clean on this, it could get much more serious than we might anticipate.
Gene, John and I were very glad to provide you with time in front of this group and it you should need additional time at future meetings (next one is Feb. 2001) please let me know. It was great meeting you as well.
Regards,
Tom
Robert W Baker
To: Charles M Beasley JrIAM/LLY(at)LiIly, Alan Breier lAM/LLY(at)Lilly 10/09/2000 0342 PM cc: Christopher C Bomba IAM/LLY(at)LILLY, Patrizia CavazzoniIAMILLY(at)Lilly, Suni KeelingIAM/1..LY(at) LILLY
Subject: Re: meeting with endocrinologic consultants
FYI. My take was that this board of academic endocrinologists was impressed enough by magnitude of weight gain and number of reports in the spontaneous adverse event database that they were predisposed toward skepticism to any analysis that did not find higher hyperglycemia rates on olanzapine than comparators.
Charles - do you think it appropriate to look at secondary analysis that does not exclude baseline abnormals and another looking at mean changes in glucose?
Alan - I believe that what Tom is referring to as “not the way Lilly typically does business†are suggestions to more vocally assert that olanzapine may have a problem on the glucose issue and, rather than moving forward with our analyses, turning all info over to an independent board for review, conclusions, and dissemination. Neither strikes me as the appropriate step, but this alarmed the Lilly attendees when linked to the Rezulon comparison. Charles did let them know that already we have sent several volumes with all our info to FDA, but I’m not sure that they fully appreciated this.
Thanks,
R
Patrick Valtin - Defender of Human Rights » Blog Archive » Does A Clinical Trial Database Belong On The Internet?
[...] Trials on a public database which would be available to you on the net.  Vote YES now here: http://www.pharmalot.com/2007/09/does-a-clinical-trial-database-belong-on-the-internet/   and pass this on to all you know so it can be forwarded to [...]
J Via
The arguments FOR are concerned with the supposition that helpful honest products are being researched and produced and information about their trials would hinder their profits. But that is the problem. We are not dealinyg with honest products or help but only the last - profits. The pharmaceuticals industry is and has been betraying us and lives in high numbers aree being lost - choldren’s lives, adult’s lives, celebrities’ lives (Richard Jenni, Anna Nicole Smith to name a few recently) - by drugs that kill, drugs that now have black box warnings that they cause suicidality and homicidality. Why are these drugs even on the market except for propaganda that they are “helpful”, that they are based on a “chemical imbalance in the brain” - yet there is no science but only opinion and a vote at a psychiatric convention. Why aren’t we demanding TRANSPARENCY! The ONE THING that will bring the TRUTH out of their own mouths! Honest people DO deserve protection of privacy - but when you smell a rat - and by now you SHOULD - the rat deserves NO such priviledge to hide amongst the honest.. It deserves to ANSWER UP and account for dead and murdered men women and children.
Amy Philo
As an informed activist I know that the trial data has been hidden per the drug companies’ whims. The only fair thing to do is to give the public access to the information. So what if a few people don’t get it? You can always look into the studies and read the results and figure out when and if conclusions have been written in a biased way.
When drug companies are permitted to hide NEGATIVE trials then the public is not safe. It’s the government’s job to protect us from someone out to harm us. If a drug is dangerous, and we’re being lied to, then the government should step in and protect us.
I would say let’s go a step further. Not only should all the information be released, but we need to reevaluate what we consider “safe” and ban the killer drugs.
We need to have large studies conducted and rewrite the labels on drugs based on ACTUAL facts and not just the few examples the drug companies fixed and fabricated and twisted and lied about to make themselves look good.
The only reason this bill has any opposition is because some people put profit over safety, and they are raking in huge amounts of cash for THEMSELVES when we fill more of these EXPENSIVE, often patent-protected prescriptions.
Randy Smith
Yes on full disclosure and perhaps the website could contain some simple definitions of more specialized terms. After all, the consumer is the end target of the endeavor. If I were on the development end I would want others to know my intentions and help educate them in the process!
Randy Smith
Yes on full disclosure and perhpas the website could contain some simple definitions of more specialized terms. after all, the consumer is the end target of the endeavor. If I were on the development end of this opportunity I would want others to know my intentions and help educate them in the process.
abraham gomez
yes
Alan
Ignorance is a peculiar thing: once it has been disspelled, it cannot be reconstituted.
Thomas Paine: The Rights of Man
In these days of “choices”, what right does any form of free government hold to deny individuals information with regards to their personal health choices? The claim that ‘biases’ MAY exist is a relatively moot issue. At the core is the consumer’s right to be informed regarding not only on WHICH PRODUCT to choose, but the effectiveness (or lack there of) and whether or not they wish to spend THEIR MONEY on that product.
The avarege consumer holds dear that right to be informed of options, durability, or risks with virtually every product which they choose to consider. As an example, look to the side-label of any household paint can: warnings abound of the potential hazards. Yet there are those who believe we Americans are too ignorant to make the choice in our medications. Balderdash!
Americans should demand that an online version of a PDR be made available in a language which is understandable by the public… ut then again, the opposition would argue that this information is provided by the pharmacy at the point of purchase. What lacks then, is informed consent BEFORE the decision is made to purchase. RE:, Big Pharma’s loss of advantages, should they been better stewards of their industry and used reasonable approaches in finding cures - rather than selling with profit and volume in mind - we Americans would not be calling for the remedy as such as it is.
Eddie Allen
What does it say about the manufacturers that are opposed to scrutiny? If a product proves unsafe, what responsible individual would want it sold to the public?
Looking at the free market system we aspire to in America, doesn’t it benefit an automobile manufacturer that can tout it’s positive crash test rating? If that data were hidden from the public, what would be the benefit? Does the data drawn from crash tests hinder the manufacturer’s ability to compete? Is this an equitable analogy or can you think of a more accurate one? What industry discloses their safety testing?
Sally A
I think it is high time that the drug trials are published. The public should not only know what the results are, but should be informed on the way the tests were done. That way, the short period of testing a drug on someone off the street (not necessarily having the condition supposedly handled by the drug) could be made public.
Larry Monroe
Full disclosure, full transparency is the only sane option. If the world had been told honestly of all the side-effects that surfaced on Prozac, it might not have been bought by millions of unsuspecting public. And it might have become infamous in the annals of FDA history as having more public complaints logged against it than almost any drug of its sort around.
Of course - when bright lights are shown into the darker corners of our culture - the rats and cockroaches are extremely uncomfortable and must run away.
The public needs this Trials Database - Big Pharma fears it.
Sandy C.
Yes, this data is needed. All the data on the drugs and their side effects are must be available to the public so that we can know the actual risks involved in taking some drug. As another person said, defining the more complex terms simply would also be a good benefit.
BigPharma should not be allowed to continue to trick and cheat the public in the name of more money for the drug companies.
Marc Torres
If there is nothing to hide by the BifPharma. All information should be available and in the open for everybody
cindy
Can you tell me about prozac?
Jeff
Since many physicians dispense scrips irresponsibly, often because they cannot and do not fully understand the underlying medical issues with which their patients present, an educated consumer is the best defense against the use of contraindicated medication and otherwise toxic pharmaceuticals. Big Pharma deserve a fair return on investment, but that does not require that they operate in the dark.
Jill Walker
It’s important to be open about the liabilities of drugs & be able to know the results & outcomes that can occur from their use. If there’s been specific negative trials that have proven a drug unsafe, it is the consumers right to be informed about it.
Leigh
It’s time to put ethics over profits. These unethical individuals are actually not too smart because they do not realize that what they are doing is hurting their family and friends and ultimately themselves, too.
It’s time to stop following these idiots!
KLCarlson
I worked in the pharmaceutical industry. The public is not aware that clinical trials with negative results are not submitted to the FDA when drug approval is sought by drug companies. Clinical trial data does not give any information about drug development away. Trial data provides the type of people that were included in the trial, their health conditions, ages, and gender. The reason it is important for the public to have access to ALL clinical trial data is because it includes the types and percentages of adverse events (side effects). As I report in my soon to be released book, Diary of a Legal Drug Dealer, the FDA has often approved drugs that they knew had extremely dangerous side effects and did not offer improved benefits over older drugs already on the market. The various psychiatric drugs are excellent examples. The public pays - with their health, lives, and tax dollars.
Mary Cetan, Dr. Oriental Medicine
Yes, education is the key, people deserve to make an educated choice. The public must have access to all clinical trial data from the drug companies. We don’t need the onslaught of drug therapies with so many dangerous side effects. Nature has provided us with safe herbal therapies that are not dangerous nor expensive and work to assist the body to heal.
Ruthanne
Yes - this should be available on the internet
PatR
I believe in Knowledge. Truth. Full Disclosure. If Big Pharma is fighting this, that can only mean they are hiding something or don’t want the effects of their drugs known to the public.
Debbie
Yes, there should be full disclosure about something so important. I agree with PatR. If they are trying to stop it, they are must have something to hide.
Songbd
When you are considering taking a drug or have a friend or family member considering taking a drug in order to take responsibility for your decisions you have to have ALL OF THE DATA.
That way, if something goes wrong but you had all of the data and it was easily understood and not in pharma jargon that would prevent easy understanding then no one is blamed. And the responsibility is fully with the person who KNOWING ALL OF THE DATA still decided to take the drug.
This is the only way that everyone wins.
BUT, look at any drug ad in any magazine and you will see streams of words written so close together and in such volume that the average person even the average very very literate person can’t easily confront and read AND FULLY UNDERSTAND.
Brian Dawson
I vote yes on this issue! Let the truth be told.
Cecilia J. Shook
The public needs to know just what these drugs are capable of doing. What is the real end product of using them?
Margaret Addison
The public has an ABSOLUTE right to full disclosure. Had it been known what the side effects of prozac were, such vast suffering, not to speak of actual loss of life, could have been averted. We’re taking about real people here who DIED.
As usual BigPharma wants to hide the truth; let’s for God’s sake be rational and sane and give the people what is their right and have FULL DISCLOSURE AND FULL ACCESS TO ALL THE DATA. Anything less is just taking us back to the of the Middle Ages.
I vote that the TRUTH BE TOLD.
Stardancer
All you need to do is follow the money and you’ll have your answer. When it’s to someone’s advantage to hide something under false pretenses (like the public is too stupid to understand the data) we’re in big trouble. I want the information posted.
Jerry Langenfeld
I vote yes. The truth must be presented.
Jim
I vote yes, full disclosure. No secrets please.
Edie Bartell
I vote yes. Edie
Reality
This is a copy and paste of my response to the previous post on this subject:
I guess I’m a little confused. PhRMA began hosting clinicalstudyresults.org in 2004, in which companies reported results on any study not published (or submitted to a journal within the year of study end), with companies backfilling results to studies completed as of October 2002.
Granted, this is different than the FDA hosting one, but I think it’s quite misleading of consumersunion.org to say that the pharmaceutical industry isn’t/doesn’t want to disclose results.
Moreover, from the article, it seems that the administration isn’t opposed to an FDA database, but rather, are opposed to the 2 areas mentioned in the bill: the FDA can’t confirm the accuracy, and that the lay summaries may be biased.
Angie
I VOTE YES.
Barbara Dennis
My 40+ years in the medical proffesion says to me ,Yes for more reasons than I have time to respond to. When are you going to stop your legal distruction to those that are in need of a trustworthy government? I know the answere to my question, but I’m always praying for a change in this sick Social System.
David
I vote yes.
Dr. Jan
The idea here isn’t to give away trade secrets. It is to inform potential consumers of any and all risks and side effects. Doctors often don’t have or take the time to go over all these despite the law requiring them to get informed consent on procedures and drugs. The drug companies in their ads state only the most common side effects and then make it sound like it isn’t a big deal. They say it in soft spoken words with pictures of happy people on the TV. Let’s get real. All drugs have side effects and they aren’t something to smile over, and some of them are very serious. People need a way to get the unbiased truth and an internet database would allow that to occur.
Louis
Yes
Dotti Thomas
In favor of full disclosure. My reasons have already been stated by previous voters.
pamela taylor
I vote yes as full disclosure requires someone to be accountable and ditto on other responses.
Jenny
The second poster made an interesting point about drug makers not being able to protect their profits by not releasing clinical trial data. However, it is not market hijacking they should be afraid of. It is the fact that no one’s going to buy a drug that has been proven to be dangerous. They will no longer want to spend millions on research to find expensive TREATMENTS when the cures are already known through alternative medicine, and cost little to nothing. There is no money in cures for big pharma, and so their “research” is without any purpose but profits.
michael scheuermann
we need a reform in psychiatric treatment which turns into
a treatment which helps the people and doesn´t kill them.
Alberto
Definitely YES!!!
edson Jeffs
I vote yes
Teresa
I find it to be very discusting and shameful when the health
and well being of a countrys people is ignored and placed second to profits. Its time for the people to stand against this
atrocity and make it about the health of people NOT MONEY!
I definatly vote yes and it is about time. Amen
pauline
Healthcare must be independent and not be allowed by law to recieve any money or benefit from pharmaceutical companies. It must be clear ,when resaerch results are published who has payed for it.
Cheryl-Anne
The only obstacles we have to curing disease are the ones we put in place ourselves.
As a cancer patient myself I have both benefited and been harmed by clinical trial data. When the information is not easily accessible to the buying public (the patient) then companies can “spin” data anyway they want. This is very harmful to the patient and interferes with the patients ability to be fully informed about their condition and treatment. It therefore interferes with patients autonomy.
Furthermore, it impedes the entire research process and I would even argue that it derails research to the point where time, effort, energy and resources are wasted on worthless “make work” projects. This adds artificial costs to the system which in turn drives up the costs of drugs in the process.
It should be completely embarrassing to some of the dimwits driving these arrogant attempts at cover ups and lies to remember that the truth always outs.
So, yeah, bring on the full disclosure. The only person I want to decipher my clinic trial data with is my doctor - he is the only one who is as vested in my wellbeing as I am.
The “us” versus “them” needs to stop, it is all “we”.
What a wicked web we weave, when OURSELVES we wish to deceive…
Aa'Ishah Salaam
I get tired of the large pharmaconglomerates hiding information that can cost lives. Full disclosure should definitely be mandated.
Bhanuprakash Panchanahalli
An Absolute YES!
Charlene
An Absolute YES
K. Sweigart
Of course YES! The TRUTH needs to be known — whatever that truth may be. The question should be: why are the pharmacological companies, FDA, government officials and others NOT interested in ALL the data and ensuring the full truth is known? Perhaps there are some vested interests here?
Lee
I help children who have been told that they have ADD/ADHD. I work with parents, educators and health care professionals, providing information so they are able to make the best decisions for the health and well being of these children.
I ask them several simple questions. “Do you believe your son/daughter has a Mental Disorder?” Over 90% respond “NO.” They are told that ADD/ADHD is a Learning Disability or a Learning Disorder, when in fact ADHD is a Mental Disorder (314 of the Diagnostic and Statistical Manual of Mental Disorders).
The public needs to know the truth.
thunderrun
No company has the right to put the lives and sanity of people at risk to “turn a buck”. People have the right to full disclosure of all information regarding any form of treatment. These drugs are no exception.
Grazia
YESSSSS!!!!!!!!!!!!!!!!
mike mikowski
I know this will sound unbelievable but if you read and apply
the simple scientifically proven techniques in the book, “A Cure
for All Diseases” you will experience that almost all pharma-
ceuticals are unnecessary. Remove disease causing industrial
age chemicals from your body instead of taking drugs whose
side effects cause more harm.Cure yourself,
Carolyn K
Yes, of course there shhould be ALL information available.