The Medical Device Safety Act -- Track the progress at http://www.govtrack.us/congress/bill.xpd?bill=s111-540 Check out who supports and opposes this bill, and contact your representatives.
Synvisc is classified as a class III “medical device.” It received FDA approval through the Pre-market Approval process. This classification and means of approval by the FDA means that the pharmaceutical company, Genzyme, is protected from virtually any liability if something goes wrong with the injection. This leaves the door open for recklessness with NO accountability! And this includes ALL medical devices approved through this avenue. Not just Synvisc.
"This bill would overturn Riegel v. Medtronic, which held that the express preemption provision of Section 360k(a) of the Medical Device Amendment to the Food, Drug and Cosmetic Act preempts state-law claims seeking damages for injuries caused by medical devices that received pre-market approval from the FDA." [Read more about recent US Supreme Court decisions regarding Medical Devices.] Proposed Changes At FDA And Proposed Legislation Threaten Both Pharmaceutical And Medical Device Companies at http://www.mondaq.com/article.asp?articleid=76834Manufacturers of drugs are also seeking pre-emeptive protection based on "Riegel vs Medtronic." If you think prescription drugs are dangerous now, wait until their is NO legal recourse.
The Physicians Payment Sunshine Act 2009 would require transparency between pharmaceutical companies and physicians. YOU should know who "owns" you physician's decisions and opinions. Track it here http://www.govtrack.us/congress/bill.xpd?bill=s111-301 and contact your representatives to support this Act.
Showing posts with label Congress. Show all posts
Showing posts with label Congress. Show all posts
Thursday, September 3, 2009
Wednesday, July 15, 2009
A Synvisc Warning of a Different Kind
Things to consider if a third party insurance is paying for your Synvisc Injections, such as Worker's Compensation, Auto Insurance, Property Insurance, etc.
If you have an adverse reaction to this injection, the situation could get sticky.
One, the physician that you trusted to inject you could EASILY deny your adverse event because they are covering their own interests and possible ties to the company. [Hence the need for the Physician Payment Sunshine Act 2009 to pass!!! Contact your senator http://www.senate.gov/ ] The insurance company will JUMP at the chance to NOT pay for what could be a long lasting health issue...and very costly. None of the above will likely be invested in YOUR best interest, only their own. [unless you're really LUCKY]
Two, the insurance company will jump at ANY chance to NOT pay, even if your reaction fits the possible adverse reactions listed on Genzyme's information sheet for Synvisc. They will fight you, and unfortunately, most physicians you might be referred to don't have the balls to stand up for the patient or the TRUTH. The odds are in favor that the medical community will side with the pharmaceutical company. Odds are that they will say that you suffer from a psycological issue, or will cover it up by saying it's related to a pre-existing condition or another prescription you're taking, or that your adverse event is not related to the Synvisc injections.
Some of the above has happened to ME, and All of the above has happened to many others who have contacted me regarding their experience with Synvisc.
Do you get it?? You WILL be on your own!!!!
Again, Why take the risk?
????
If you have an adverse reaction to this injection, the situation could get sticky.
One, the physician that you trusted to inject you could EASILY deny your adverse event because they are covering their own interests and possible ties to the company. [Hence the need for the Physician Payment Sunshine Act 2009 to pass!!! Contact your senator http://www.senate.gov/ ] The insurance company will JUMP at the chance to NOT pay for what could be a long lasting health issue...and very costly. None of the above will likely be invested in YOUR best interest, only their own. [unless you're really LUCKY]
Two, the insurance company will jump at ANY chance to NOT pay, even if your reaction fits the possible adverse reactions listed on Genzyme's information sheet for Synvisc. They will fight you, and unfortunately, most physicians you might be referred to don't have the balls to stand up for the patient or the TRUTH. The odds are in favor that the medical community will side with the pharmaceutical company. Odds are that they will say that you suffer from a psycological issue, or will cover it up by saying it's related to a pre-existing condition or another prescription you're taking, or that your adverse event is not related to the Synvisc injections.
Some of the above has happened to ME, and All of the above has happened to many others who have contacted me regarding their experience with Synvisc.
Do you get it?? You WILL be on your own!!!!
Again, Why take the risk?
????
Thursday, July 9, 2009
Physicians Payment Sunshine Act 2009 Update
This act would require exposure of financial ties between physicians and pharmaceutical companies, medical supply companies and manufacturer of medical devices. This relationship should be transparent. If you've read this blog, you'll understand why I support the efforts of Sen Charles Grassley to pass the Physicians Payment Sunshine Act 2009.
This has currently reached the Senate Finance Committee which is made up of the following senators. Contact them and support transparency in our health care system. Decisions should be made in the best interest of the patient...not big business and your doctor. This act would expose the ties that could interfere with the best choice for each patient...for YOU.
www.govtrack.us/congress/committee.xpd?id=SSFI
Contact them today.
This has currently reached the Senate Finance Committee which is made up of the following senators. Contact them and support transparency in our health care system. Decisions should be made in the best interest of the patient...not big business and your doctor. This act would expose the ties that could interfere with the best choice for each patient...for YOU.
www.govtrack.us/congress/committee.xpd?id=SSFI
Contact them today.
Monday, June 15, 2009
Exposure of Pay-Offs--Physicians Payment Sunshine Act
I recently learned of the Physicians Payment Sunshine Act which wants to expose physicians who receive money and benefits from manufacturers of medical devices, medical supplies and pharmaceutical companies.
I applaud this effort as I firmly believe that when my orthopedic surgeon selected Synvisc as the viscosupplemtation for me, he did not consider my severe chemical sensitivities noted to him many times. Several studies printed in peer-review medical journals show that this viscosupplementation produces significantly more adverse events compared to others on the market. I believe my orthopedic surgeon considered the product over this patient, and I'm likely NOT the first, and saddly not the last. It would not surprise me to find a financial connection between the two parties.
This bill has not made if very far in prior congressional sessions, yet fortunately for patients, Senator Grassley of Iowa has not given up. It doesn't take much to realize why the Physicians Payment Sunshine Act has not passed to date. Follow the money. Pharmaceutical companies do not want this kind of exposure, and neither do the members of the American Medical Association. Both highly powerful groups with lobbyist...MONEY buys our laws unless we elect congressman who have ethics and who care.
Pressure your US Congressmen/women to support this into law. Do not be complacent. What do the physicians and drug companies have to hide if the exchange of money and benefits is not unethical?
Sen. Charles Grassley [R-IA] is the sponsor of this bill. To learn more about the status of this bill and co-sponsors, go to www.govtrack.us/congress/bill.xpd?bill=s111-301
Chairman Kohl said, “If these physicians are essentially putting their medical judgment up for sale, where does the patient’s well-being fit into the equation?” Check out report at http://aging.senate.gov/record.cfm?id=294092
Visit Dr Charles Rosen's site for more information on his fight to make this happen
http://www.ethicaldoctor.org/
Contact your senator today
http://www.senate.gov/
[Note: this is not meant to be a political statement, favoring one party over the other. This is meant to stimulate change in our government for our health's sake, no matter what side you're on.]
I applaud this effort as I firmly believe that when my orthopedic surgeon selected Synvisc as the viscosupplemtation for me, he did not consider my severe chemical sensitivities noted to him many times. Several studies printed in peer-review medical journals show that this viscosupplementation produces significantly more adverse events compared to others on the market. I believe my orthopedic surgeon considered the product over this patient, and I'm likely NOT the first, and saddly not the last. It would not surprise me to find a financial connection between the two parties.
This bill has not made if very far in prior congressional sessions, yet fortunately for patients, Senator Grassley of Iowa has not given up. It doesn't take much to realize why the Physicians Payment Sunshine Act has not passed to date. Follow the money. Pharmaceutical companies do not want this kind of exposure, and neither do the members of the American Medical Association. Both highly powerful groups with lobbyist...MONEY buys our laws unless we elect congressman who have ethics and who care.
Pressure your US Congressmen/women to support this into law. Do not be complacent. What do the physicians and drug companies have to hide if the exchange of money and benefits is not unethical?
Sen. Charles Grassley [R-IA] is the sponsor of this bill. To learn more about the status of this bill and co-sponsors, go to www.govtrack.us/congress/bill.xpd?bill=s111-301
Chairman Kohl said, “If these physicians are essentially putting their medical judgment up for sale, where does the patient’s well-being fit into the equation?” Check out report at http://aging.senate.gov/record.cfm?id=294092
Visit Dr Charles Rosen's site for more information on his fight to make this happen
http://www.ethicaldoctor.org/
Contact your senator today
http://www.senate.gov/
[Note: this is not meant to be a political statement, favoring one party over the other. This is meant to stimulate change in our government for our health's sake, no matter what side you're on.]
Wednesday, May 27, 2009
Medical Device Pre-emptive Protection by the US Supreme Court
Synvisc is classified as a class III “medical device.” It received FDA approval through the Pre-market Approval process. This classification and means of approval by the FDA means that the pharmaceutical company, Genzyme, is protected from virtually any liability if something goes wrong with the injection.
The “injected gel” that eventually ends up in your bloodstream DOES NOT have to follow the same stringent guidelines as a product classified as a “drug” by the FDA. Genzyme offers no data regarding the “systemic half-life” or the “metabolic pathway” or “how do you get this out of your system”…especially under life-threatening reactions.
We can thank the US Supreme Court whose decision on Feb 20, 2008 through RIEGEL v. MEDTRONIC, INC. which gave free range to the pharmaceutical industry to produce harmful medical devices with no accountability...oh, except through the FDA. The FDA has a history of approving many defective and deadly medical devices and drugs in recent years. Read
http://www.rd.com/your-america-inspiring-people-and-stories/fda-approves-harmful-antibiotic/article55526.html
The US Supreme court voted 8:1 to protect BIG MONEY (ie: manufacturer’s of medical devices) from any liability if the product causes harm to a patient.
http://www.supremecourtus.gov/opinions/07pdf/06-179.pdf
http://www.afj.org/check-the-facts/cases/medical-device-safety-act-2008.html
Contact your US Congressman regarding this ruling and support "The Medical Device Safety Act."
"This bill would overturn Riegel v. Medtronic, which held that the express preemption provision of Section 360k(a) of the Medical Device Amendment to the Food, Drug and Cosmetic Act preempts state-law claims seeking damages for injuries caused by medical devices that received pre-market approval from the FDA." [Read more about recent US Supreme Court decisions regarding Medical Devices.
Proposed Changes At FDA And Proposed Legislation Threaten Both Pharmaceutical And Medical Device Companies at http://www.mondaq.com/article.asp?articleid=76834
Manufacturers of drugs are also seeking pre-emeptive protection based on "Riegel vs Medtronic." If you think prescription drugs are dangerous now, wait until their is NO legal recourse.
The “injected gel” that eventually ends up in your bloodstream DOES NOT have to follow the same stringent guidelines as a product classified as a “drug” by the FDA. Genzyme offers no data regarding the “systemic half-life” or the “metabolic pathway” or “how do you get this out of your system”…especially under life-threatening reactions.
We can thank the US Supreme Court whose decision on Feb 20, 2008 through RIEGEL v. MEDTRONIC, INC. which gave free range to the pharmaceutical industry to produce harmful medical devices with no accountability...oh, except through the FDA. The FDA has a history of approving many defective and deadly medical devices and drugs in recent years. Read
http://www.rd.com/your-america-inspiring-people-and-stories/fda-approves-harmful-antibiotic/article55526.html
The US Supreme court voted 8:1 to protect BIG MONEY (ie: manufacturer’s of medical devices) from any liability if the product causes harm to a patient.
http://www.supremecourtus.gov/opinions/07pdf/06-179.pdf
http://www.afj.org/check-the-facts/cases/medical-device-safety-act-2008.html
Contact your US Congressman regarding this ruling and support "The Medical Device Safety Act."
"This bill would overturn Riegel v. Medtronic, which held that the express preemption provision of Section 360k(a) of the Medical Device Amendment to the Food, Drug and Cosmetic Act preempts state-law claims seeking damages for injuries caused by medical devices that received pre-market approval from the FDA." [Read more about recent US Supreme Court decisions regarding Medical Devices.
Proposed Changes At FDA And Proposed Legislation Threaten Both Pharmaceutical And Medical Device Companies at http://www.mondaq.com/article.asp?articleid=76834
Manufacturers of drugs are also seeking pre-emeptive protection based on "Riegel vs Medtronic." If you think prescription drugs are dangerous now, wait until their is NO legal recourse.
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