Post by kilg0retr0ut on Jan 1, 2014 9:15:50 GMT -8
Whats the alternative? Do you have a better working model? While reading the article I was thinking about a book I read about Carl Sagan. Would he be considered an IP? It's easy to show how things are broken, much more difficult to fix them. How can we make things more transparent? I agree that a great deal of money is being wasted.
Whats the alternative? Do you have a better working model? While reading the article I was thinking about a book I read about Carl Sagan. Would he be considered an IP? It's easy to show how things are broken, much more difficult to fix them. How can we make things more transparent? I agree that a great deal of money is being wasted.
Would be good to hear some feedback and opinion from the OP but i agree with your points kilg0retr0ut
Here is another article from Bill Frezza. Here he talks about the FDA:
"A report recently released by the Milken Institute—“The Global Biomedical Industry: Preserving US Leadership”—documents how the wheels of progress have been slowly grinding to a halt as the FDA raises the bar for drug approval. The length of time required to complete clinical trials over the past decade is up 70%. The median number of procedures required per trial is up 50%, as is the total work burden per protocol. Meanwhile, volunteer enrollment and retention has been driven down by 21% and 30% respectively. And, of course, new drug approvals are down 50%. " ... "Is there an alternative?
While wholesale FDA reform is needed, doing it right would entail a monumental effort that could take years. But there are modest steps we can take in the meantime. How about carving out one or more FDA-free Enterprise Zones where doctors, scientists, and volunteer patients can make their own decisions unfettered by the heavy hand of regulators? Imagine an experimental terminal-illness wing of the Cleveland Clinic where informed consent was the only law. How hard would it be to draft enabling legislation?"
There are other possible alternative models to medical research.. I'll dig out of my PC few articles on the issue in the next few days and post it here.
I'm not surprised with that at all though, the FDA is pure politics and as far as I can see has nothing to do with the concern & safety of the drug consumers
"Medicine's Missing Measure" ... "The FDA's mission is to protect the consumer. They are the white hats, the good guys who are perennially untroubled by imposing additional trials or larger patient population samples on manufacturers, or meticulous and lengthy decision making processes within universities and federal agencies. Why should they be? According to ex-FDA commissioner Alexander M. Schmidt: "In all of FDA's history, I am unable to find a single instance where a congressional committee investigated the failure of the FDA to approve a new drug. But, the times when hearings have been held to criticize our approval of new drugs have been so frequent that we aren't able to count them....The message to FDA staff could not be clearer."
Imagine if we approached automotive safety in the same way that we approach drug and..." ... "If the cost and investment required to bring a new drug to market gets above a certain level, then no company will invest in a discovery"...
Whats the alternative? Do you have a better working model? While reading the article I was thinking about a book I read about Carl Sagan. Would he be considered an IP? It's easy to show how things are broken, much more difficult to fix them. How can we make things more transparent? I agree that a great deal of money is being wasted.
Here is a sistemic alternative approach to medical research as proposed by Joseph E. Stiglitz, a Nobel laureate in economics and University Professor at Columbia University, was Chairman of President Bill Clinton’s Council of Economic Advisers...
"Prizes, Not Patents"
"Part of modern medicine’s success is built on new drugs, in which pharmaceutical companies invest billions of dollars on research. The companies can recover their expenses thanks to patents, which give them a temporary monopoly.." Read more at www.project-syndicate.org/commentary/prizes--not-patents#6RAyCaOkQuL1JRKm.99
Here is another article from Bill Frezza. Here he talks about the FDA:
"A report recently released by the Milken Institute—“The Global Biomedical Industry: Preserving US Leadership”—documents how the wheels of progress have been slowly grinding to a halt as the FDA raises the bar for drug approval. The length of time required to complete clinical trials over the past decade is up 70%. The median number of procedures required per trial is up 50%, as is the total work burden per protocol. Meanwhile, volunteer enrollment and retention has been driven down by 21% and 30% respectively. And, of course, new drug approvals are down 50%. " ... "Is there an alternative?
While wholesale FDA reform is needed, doing it right would entail a monumental effort that could take years. But there are modest steps we can take in the meantime. How about carving out one or more FDA-free Enterprise Zones where doctors, scientists, and volunteer patients can make their own decisions unfettered by the heavy hand of regulators? Imagine an experimental terminal-illness wing of the Cleveland Clinic where informed consent was the only law. How hard would it be to draft enabling legislation?"
There are other possible alternative models to medical research.. I'll dig out of my PC few articles on the issue in the next few days and post it here.
Paolo
Thanks for putting this up Paolo. I think it it is a worthy discussion to have especially if we consider what can really be done for SCI curative therapies. I have been searching around the internet since yesterday and have found some interesting information.
I agree with the fact that the FDA is demanding more and more for approval and maybe the FDA also thinks the same. I also agree with part of the Competitive Enterprise Institute (more about this group later) Mr. Frezza's statement that, "While wholesale FDA reform is needed, doing it right would entail a monumental effort that could take years. But there are modest steps we can take in the meantime."
The idea that modest steps can be taken in the meantime is something completely plausible and is something that the FDA itself may be interested in exploring. In February of last year the FDA held public hearings under the title Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need; Public Hearing You can see the notice here. I have a lot more reading to do about the outcome and would love to hear from anyone who was involved. I am also trying to read through the google search materials that came up when I typed in the title of the hearing.
The explanation of the public hearing is as follows: The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on a potential new pathway to expedite the development of drugs, including biological products, for serious or life-threatening conditions that would address an unmet medical need. The drug's safety and effectiveness would be studied in a smaller subpopulation of patients with more serious manifestations of a condition. Such a pathway could involve smaller and more rapid clinical trials than would occur if the drug were studied in a broader group of patients with a wide range of clinical manifestations.
I think that based on what we know about SCI it falls under the serious or life-threatening conditions. This is the area that we in the SCI community, especially our American friends could have an impact on.
Mr. Frezza's idea that, "carving out one or more FDA-free Enterprise Zones where doctors, scientists, and volunteer patients can make their own decisions unfettered by the heavy hand of regulators," is something that it is not going to happen in America and if it did, I would consider to be a scary proposition.
He paints a beautiful picture of doctors, scientists, and volunteer patients all making their own decision, but it will just end up leading us back to the reason why we have drug approval processes in the first place. In short order it will end up dominated by big pharma because all research needs money and the most promising research will be financed by those who want to make more money. As many of us do, I've always had my nervous feeling about big pharma and after reading this article on their out and out fraud (a list of real fines that big pharma pays because of fraud not an emotional appeal), I am even more opposed to Mr. Frezza's idea.
I'm surprised that someone like Mr. Frezza would even suggest such a simplistic idea and because he offers no more than the "invisible hand of free research" as an answer, comes off sounding rather naive (Paolo, this is not aimed at you because I know you're raising it just as one idea as opposed to the idea).
But of course Mr. Frezza is going to say things like this. A fellow at the Competitive Enterprise Institute whose byline is "free markets and limited government" is not going to say anything different, is he? We all have bias so it's important to be clear on what it is and recognize it. This institute says that it is "dedicated to advancing the principles of limited government, free enterprise, and individual liberty," which sounds just like an ad for the Tea Party. Mr. Frezza didn't come to this conclusion after looking at all the options and information; he started with this conclusion already in mind and just fit in a few facts about the problems with the FDA's process. Thank the Lord that it ain't never ever going to happen.
Therefore, if we want to have a real discussion, it needs to be based on how we can impact the FDA's process regarding trials for SCI.
So, does anyone know if this process is still going on? The public hearings were on 4 and 5 February 2013, but is it done? Has anyone participated? Does anyone know how you deal with public hearings in America after the public hearing part is finished?
I'll also look. ______________________________________
Below is the information on the scope of the public hearings and the discussion points AND here are the transcripts (which I haven't read yet).
FDA is holding this public hearing to seek input from interested members of the public including patients and consumers, practitioners and other members of the medical community, regulated industry, insurers, and managed care organizations on a potential new pathway to approve drugs shown to be safe and effective in a subpopulation of patients with serious or life-threatening conditions in which an unmet medical need exists. FDA is interested in obtaining information and public comment on the following issues:
1. Considering existing processes to expedite drug development and review of important new therapies (i.e., accelerated approval, fast-track designation), would this new pathway increase the therapeutic options for serious or life-threatening conditions for which an unmet medical need exists? If not, what might be some alternative approaches?
2. Can you identify specific serious or life-threatening conditions for which an unmet medical need exists and for which this approval pathway may benefit subpopulations of patients?
3. What approaches could be undertaken (by FDA or by people or organizations other than FDA) to monitor use of drugs approved under this pathway to determine whether they are being used inconsistent with the terms of approval? What approaches could be undertaken to prevent, manage, or monitor use in a broader population where safety and efficacy has not been demonstrated? For example, if this pathway were adopted to approve new antibacterial drugs when limited use was needed (e.g., to prevent the emergence of further antimicrobial resistance), what other measures (by FDA or by people or organizations other than FDA) might ensure that these products are used appropriately only in the indicated subpopulations?
4. Would this pathway help to address some of the current challenges in antibacterial drug development, particularly for serious or life-threatening infections for which there is an unmet medical need?
5. This potential pathway could be used to approve drugs for a limited subpopulation based upon smaller clinical trials, when benefit-risk is appropriate for the limited population but safety and efficacy have not been demonstrated for use in a broader population of patients or patients with less severe manifestations of the condition. For the serious or life-threatening conditions you identified in question 2, what benefit-risk considerations need to be taken into account before and after marketing and how should they be addressed?
6. Would the use of a formal designation and logo to reflect approval under this pathway, with clear labeling of clinical information that only supports use in the indicated subpopulation, but without other constraints from FDA be effective in limiting use to the indicated subpopulation? Why or why not?
Dennis Tesolat
www.StemCellsandAtomBombs.org ______________
"Change does not roll in on the wheels of inevitability, but comes through continuous struggle. And so we must straighten our backs and work for our freedom."
Martin Luther King
Whats the alternative? Do you have a better working model? While reading the article I was thinking about a book I read about Carl Sagan. Would he be considered an IP? It's easy to show how things are broken, much more difficult to fix them. How can we make things more transparent? I agree that a great deal of money is being wasted.
Here is a sistemic alternative approach to medical research as proposed by Joseph E. Stiglitz, a Nobel laureate in economics and University Professor at Columbia University, was Chairman of President Bill Clinton’s Council of Economic Advisers...
"Prizes, Not Patents"
"Part of modern medicine’s success is built on new drugs, in which pharmaceutical companies invest billions of dollars on research. The companies can recover their expenses thanks to patents, which give them a temporary monopoly.." Read more at www.project-syndicate.org/commentary/prizes--not-patents#6RAyCaOkQuL1JRKm.99
Paolo
Yes, typing in "prizes not patents" on google will bring you to a load of articles. In America the Socialist Junior Senator for Vermont had raised a bill in the Senate a few years back. Sadly, he was the only sponsor, but lately, there has been some more interest.
Unfortunately, even though I like the idea a lot, I don't think that it will change the FDA requirements as it deals more with the topic of reducing America's drug costs by stopping the monopoly that patent holders have over drug prices. But I also feel that both topics are a package that unless addressed together will not work. Awarding prizes when FDA over zealousness adds to the cost of getting approval may make the prize fund more than can be afforded as it is a one off payment as opposed to government and consumer payments over the life of the patent.
Dennis Tesolat
www.StemCellsandAtomBombs.org ______________
"Change does not roll in on the wheels of inevitability, but comes through continuous struggle. And so we must straighten our backs and work for our freedom."
Martin Luther King