Recently, The House Energy and Commerce Committee of the U.S House of Representatives unanimously passed the 21st Century Cures Act in a 51-0 vote, essentially putting pharmaceutical companies before patient safety. The U.S Senate is working on similar legislation.
Unfortunately, the 21st Century Cures Act has several provisions that are especially worrisome and would weaken consumer safety, leaving patients exposed to potentially unsafe medications.
The bill weakens an already flawed system and would lower the standards by which the FDA approves antibiotics, putting patients at risk and giving companies big shortcuts when it comes to clinical testing of high-risk antibiotics like fluoroquinolones.
If enacted into law, the 21st Century Cures Act would allow for more fast-tracking of medications, and eliminate Phase III clinical trials as a requirement for drug approval. Phase III is when the drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Eliminating this important phase would mean that the FDA would be able to approve drugs based on smaller phase II studies alone. Many medications, especially fluoroquinolone antibiotics, come with adverse reactions that are not known until long after the drug is approved. Bypassing critical safety protocols by fast-tracking medications means that more patients will not find out how dangerous they are until years later. Post-market surveillance relies on human subjects to provide the data to prove safety and effectiveness of a medication after it has been approved by the FDA. Alarmingly, there are no provisions in the 21st Century Cures Act to fund the FDA's examination of post market data.
The current version of the 21st Century Cures Act would allow consideration of drug approvals based on case studies and medical journals alone, rather than making considerations on evidence-based science and data. The legislation seems backward rather than forward-looking, contrary to what its name suggests. In an era of big data and high tech breakthroughs in medicine, institutional acceptance of non-scientific approaches sends the wrong message about the FDA's role in protecting the public. It risks losing the respect and support of the scientific community and the public. In effect, the FDA would give no more assurance than a patient's favorite health magazine which, however reputable, is not based on controlled experimental evidence, but is a collection of opinions from conflicting sources with potentially varying agendas. Patients would surely wonder whether their tax dollars are being spent wisely.
Additionally, the 21st Century Cures Act will encourage the production of new antibiotics, regardless of their safety profile or mechanism of action. The legislation includes incentives to prescribe newly developed antibiotics. Hospitals would receive a bonus for using new antibiotics, that would lead to more over-use and antibiotic resistance, which undermines one of the issues the legislation is supposed to address. Antibiotic resistance is a rapidly growing epidemic. The answer to antibiotic resistance is not the development of new antibiotics. It is the over-prescribing and over-use of existing antibiotics that caused it in the first place. Instead of using fluoroquinolone antibiotics as a last resort for life-threatening infections such as anthrax, doctors are prescribing them for routine, simple infections for which there are safer alternatives. Encouraging the production of new, more powerful antibiotics will only compound the problem, and disable and kill people more than fluoroquinolones already are. But if the 21st Century Cures Act passes, removing regulatory and procedural requirements from the drug approval process is exactly what will be allowed to happen. Instead of protecting patients from already dangerous antibiotics, this will only encourage even more dangerous antibiotics to enter the market and put more patients at risk.
A preventable problem is a fixable problem and we can fix the flaws so patients are protected with improved treatments that are safe and effective without compromising patient safety.
The bill has already passed in the House of Representatives, but it has not in the Senate. It is up to us to voice our concerns about this legislation and let our elected officials know that patient safety should be of paramount importance and that the loopholes in this legislation must be closed. There is still time to amend legislation before more lives are destroyed.
Contact the primary authors of the bill- Congressman Fred Upton and Congresswoman Diana DeGette- and let them know how you feel about this legislation and how it will lead to more preventable harm. Also contact your Senators. The Quinolone Vigilance Foundation has already sent letters, which you may use as an example, or write your own. Please join us and demand that the Senate puts patients first. It is not too late to get this bill amended by the Senate before it becomes law.
Letter from the Quinolone Vigilance Foundation to North Carolina United States Senators Richard Burr and Thom Tillis:
Dear Senators Burr and Tillis,
I am writing to express my concern over a bill recently passed by the U.S. House of Representatives that would lower the Food and Drug Administration's standards for approving drugs and medical devices. As you consider legislation intended to promote medical innovation, I strongly urge you to reject provisions that would undermine the FDA's ability to make sure treatments are safe and effective.
In 2006, I became disabled after suffering severe adverse reactions to the fluoroquinolone antibiotic Levaquin. To date, I have ruptured ten (10) tendons, and endured over a dozen other adverse reactions including a neurodegenerative disorder, from which I will never recover.
If enacted into law, the 21st Century Cures Act would allow for more fast-tracking of medications, and eliminate Phase III clinical trials as a requirement for drug approval. Many medications, especially fluoroquinolone antibiotics, come with adverse reactions that are not known until long after the drug is approved. Bypassing critical safety protocols by fast-tracking medications means that more patients will not find out how dangerous they are until years later. Post-market surveillance relies on human subjects to provide the data to prove safety and effectiveness of a medication after it has been approved by the FDA. Alarmingly, there are no provisions in the 21st Century Cures Act to fund the FDA's examination of post market data.
The current version of the 21st Century Cures Act would allow consideration of drug approvals based on case studies and medical journals alone, rather than making considerations on evidence-based science and data. This seems backward rather than forward-looking, contrary to what its name suggests. In an era of big data and high tech breakthroughs in medicine, institutional acceptance of non-scientific approaches sends the wrong message about the FDA's role in protecting the public. In effect, this would give no more assurance than a patient's favorite health magazine which, however reputable, is not based on controlled experimental evidence, but is a collection of opinions from conflicting sources with potentially varying agendas. Patients would surely wonder whether their tax dollars are being spent wisely.
Additionally, the 21st Century Cures Act will encourage the production of new antibiotics, regardless of their safety profile or mechanism of action and includes incentives to prescribe newly developed antibiotics. That would lead to more over-use and antibiotic resistance, which undermines one of the issues the legislation is supposed to address. Antibiotic resistance is a rapidly growing epidemic. The answer to antibiotic resistance is not the development of new antibiotics. It is the over-prescribing and over-use of existing antibiotics that caused it in the first place. Encouraging the production of new, more powerful antibiotics will only injure, disable, and kill more patients instead of protecting them from already dangerous antibiotics.
But if the 21st Century Cures Act passes, removing regulatory and procedural requirements from the drug approval process is exactly what will be allowed to happen.
A preventable problem is a fixable problem and we can fix the flaws so patients are protected with improved treatments that are safe and effective without compromising patient safety.
The bill has already passed in the House of Representatives, but it has not in the Senate. Going forward, the Senate must amend the serious mistakes made by the House. I strongly urge you to put consumers first in the medical marketplace, and keep treatments safe, effective and affordable.
Please take measures to balance the 21st Century Cures Act to ensure that patient safety and consumer protection are not overlooked and adverse reactions to medications and medical devices are taken into consideration.
Thank you for your time and consideration.
Rachel Brummert
Executive Director
Quinolone Vigilance Foundation
Charlotte, NC
Response from Senator Thom Tillis on December 15, 2015
Response from Senator Richard Burr:
Response from Senator Richard Burr:
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