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National Organization for Rare Diseases "NORD" supports comprehensive healthcare reform
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masguy said:
on November 21, 2009 02:52 PM ET
edited on November 21, 2009 02:56 PM ET Twenty-two percent of our healthcare dollars are spent on 1 percent of the population. Many of those people have rare diseases. I know, I'm one of them. I have a rare cancer and just one of medications costs more than $90,000 a year. When I here people making claims about rationing it makes my blood boil, because I know that most of the advances in treatment and diagnosis for my disease have come from countries with what the scaremongers call "socialized medicine." I know over a dozen people who went to Europe to get treatments with proven effectiveness that are still not available in the U.S. It is no surprise to me then that the National Organization for Rare Diseases has endorsed comprehensive healthcare reform.
People with rare, expensive to treat diseases would be the most likely to suffer if rationing was a real possibility. If we do not fear that reform would lead to rationing, then neither should anyone else. |
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edited on November 22, 2009 07:55 AM ET
The FDA did approve the various vaccines for the swine flu, the vaccines did go through clinical trials. You certainly have it in for the FDA, but like your latest post, every one of your criticisms has been factually incorrect. First you say they don't approve life-saving drugs with known harms fast enough and then you say they move too fast in approving drugs that only have potential to harm (every vaccine harms some people) - it really can't be had both ways.
FDA NEWS RELEASE
For Immediate Release: Sept. 15, 2009
Media Inquiries: Pat El-Hinnawy, 301-796-4763, patricia.el-hinnawy@fda.hhs.gov; Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 1-888-INFO-FDA
FDA Approves Vaccines for 2009 H1N1 Influenza Virus
Approval Provides Important Tool to Fight Pandemic
The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.
“Today's approval is good news for our nation's response to the 2009 H1N1 influenza virus,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “This vaccine will help protect individuals from serious illness and death from influenza.”
The vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc. All four firms manufacture the H1N1 vaccines using the same processes, which have a long record of producing safe seasonal influenza vaccines.
”The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines,” said Jesse Goodman, M.D., FDA acting chief scientist.
Based on preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine.
Clinical studies under way will provide additional information about the optimal dose in children. The recommendations for dosing will be updated if indicated by findings from those studies. The findings are expected in the near future.
As with the seasonal influenza vaccines, the 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative, and in formulations that do not contain thimerosal.
People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.
In the ongoing clinical studies, the vaccines have been well tolerated. Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines.
For the injected vaccine, the most common side effect is soreness at the injection site. Other side effects may include mild fever, body aches, and fatigue for a few days after the inoculation. For the nasal spray vaccine, the most common side effects include runny nose or nasal congestion for all ages, sore throats in adults, and -- in children 2 to 6 years old -- fever.
As with any medical product, unexpected or rare serious adverse events may occur. The FDA is working closely with governmental and nongovernmental organizations to enhance the capacity for adverse event monitoring, information sharing and analysis during and after the 2009 H1N1 vaccination program. In the U.S. Department of Health and Human Services, these agencies include the Centers for Disease Control and Prevention.
Vaccines against three seasonal virus strains are already available and should be used (see information on the seasonal flu). However, they do not protect against the 2009 H1N1 virus (see information on H1N1 flu).
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Kind of like a drug that the FDA didn't approve but was still released, the Swine Flu Vaccine which has ingredients that has caused people to become paralyzed over time, but Obama called a "National Emergency", implying that it was the first time its been around. And, the Swine Flu Vaccine that is being targeted towards mostly the young and given through the nostril. Its an airborne disease that was never approved by the FDA.
That's the requirement of scientific investigation too. We're talking about a drug that can cause your spleen to burst, its not like it just makes you barf or your hair fall out, it can kill you. If we didn't have FDA oversight, we'd be totally at the mercy of the drug companies. And them ain't tender mercies at all.
Yep, the FDA requires that, when it could have been available much sooner. The FDA holds all of them back.
edited on November 21, 2009 09:27 PM ET
Here's a link to an article from 2007 which says that AMD3100 was still in Phase III clinical trials at that time. I found an article from 2005 which stated the drug was in Phase II at the time. One of he reasons why it may have taken so long to go from phase-to-phase is that the drug is used for people with non-Hodgkins Lymphona and Multiple Myelomas who are undergoing bone- marrow transplants after chemotherapy. You don't find folks like that hanging around on every street corner. I don't think you can blame the FDA for that.
Also there could have been problems during the phase II trial trying to find the right balance between effectiveness and safety. If you look at the package insert (it's available online), it has a very firm instruction about not exceeding the approved amount.
Nor do I think that there's anything wrong or suspicious about the fact that you can't find information about the phase II trials at the FDA. Drug makers don't submit applications until they have completed phase III trials - and the phase III data is what the drug approval/denial is based on. I hope you didn't learn about this drug because of someone you care about, but I do think your accusation is not accurate.
Yes, and it doesn't include the letters as early as 2005 which is when I first new of the drug. Amazing that I knew about this in 2005, huh?
If you check the link I used, It takes you directly to the FDA approval letter, which uses the June 2008 submission date.
My first question, out of curiosity, what happens when these Americans return home?
They have to carry a letter with them when they fly because they remain radioactive for a week or so after the treatment and they set-off the radiation detectors in the airport. Most folks do a series of treatments about two months apart. They coordinate with their local docs for follow up scans and blood tests. One of my friends was in pain for a year and half because of he location of one of her tumors - a couple of months afterwards her pain was gone.
My second question, is the $90,000 a year covered under your current health insurance?
Yes, even though is is an off-label use. After 8 years, I had become desensitized to the drug most people with my disease use. It cost about $30,000 a year more in part because it had to be administered by an oncology nurse. I can give the new drug to myself. Do you think my insurance would pay if it was the other way around?
