Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Monday, May 18, 2015

Take Action Now! Tell Congress NO on 21st Century Cures bill.

Congress is working on a bill called 21st Century Cures that would lower the standards for approving drugs and medical devices.  They say it will benefit patients, but it was written primarily by industryUnfortunately, a key vote will be tomorrow  morning 5/19/2015!

The National Center for Health Research has drafted a letter to the House of Representatives for individuals to sign with their name and city/state/zip code.  Please spread the word to friends and relatives that care about safe medical products!   
I can’t emphasize enough how important it is that Congress hear from as many individuals as possible NOW!

Diana Zuckerman, Ph.D.
President
National Center for Health Research
Cancer Prevention and Treatment Fund
1001 Connecticut Ave, NW, Ste. 1100
Washington, DC 20036
(202) 223-4000

CONSUMER VERSION
Dear Representative XXX,
As patients and consumers from across the country, we are writing to share our very strong opposition to several sections of the 21st Century Cures legislation.  A few of the issues of particular concern to us follow.  We are not lobbyists, we are American taxpayers, and we hope you will improve the bill to better reflect the needs of regular people like us. 
Subtitle D: Modern Clinical Design, Section 2062 and 2063
FDA standards have developed over the last 100 years so that Americans could trust that medical products are proven safe and effective in scientific studies on humans.  Randomized clinical trials are the gold standard to make sure that a new drug, device, or vaccine is safe and effective.  This section encourages the FDA to lower its standards to even include anecdotes that the bill calls “clinical experience.”  Please remember that clinical experience resulted in tragedies such as thalidomide and the Dalkon shield.  
Whether the FDA is reviewing a drug for a new use, for long-term studies after a drug is already approved, or for a new drug, the FDA should compare the drug to make sure its benefits are greater than its risks for most patients.  That means it needs to be studied on hundreds of men and women, of different ages and different races.  
In medicine, physicians are looking for “evidence-based medicine” not the opinions of a few doctors.  That’s why this section is so dangerous for patients: it would allow the use of individual experiences or summaries of studies (instead of the details of the studies)
 Sections 2121: Approval of Drugs for a Limited Population of Patients
We all worry about antibiotic resistance, but this section tries and fails to address it.  It discourages the FDA from relying on randomized clinical trials that evaluate the impact of a drug on real patients, and instead encourages the FDA to rely on preliminary data.  That might be justifies for patients who would otherwise die without an experimental drug, but unfortunately there is no way for the FDA to prevent these drugs from being promoted and prescribed for all patients.  Millions of patients could die as a result.
4.      Section 2123: Encouraging the Development and Use of New Antimicrobial drugs
This section would pay a bonus to hospitals to prescribe new antibiotics and anti-fungals.  But, these drugs should be used only when needed, to preserve their effectiveness as long as possible.  Many frail elderly patients are put on antibiotics whenever they get sick, in order to prevent pneumonia.  If Congress encourages hospitals to prescribe these new drugs, it encourages overuse and inappropriate use.  The result: fewer effective antibiotics and a Medicare system that goes broke even sooner than many have predicted.
5. Subtitle L, M, and N:  Medical Devices:  
FDA standards for medical devices are lower than for drugs, resulting in patients harmed from artificial hips, unsafe stents, contact lens solution, surgical mesh, and many other common devices.  The device sections in this proposed legislation would lower the standards even more.  How does that make sense? 
Section 2221, Third-party Assessment:  When a company wants to make changes to a medical device that is already on the market, FDA scientists should decide if the changes will change the safety and effectiveness of that product.  Companies should not be allowed to choose to pay a 3rd party to decide if FDA needs to review those changes.  That is just common sense.
Section 2222,  Medical Device Approvals: This section lowers the standards FDA uses to approve high-risk medical devices such as heart, brain, and spinal implants.  It would allow approval based on case studies, which include only one or two patients.  But the experience of a small number of patients is not necessarily typical of what will happen to most patients, especially patients of the opposite sex or different age.  It would also allow evidence from peer reviewed medical journals instead of evidence from the actual patient data.  Unfortunately, studies in medical journals can be inaccurate, incomplete, or biased.
Health Software: Electronic medical records and other health software help doctors make medical decisions about their patients.  That’s why it is important that the software works well and won’t crash when the patients’ lives are at stake.  FDA should evaluate these devices at least as carefully as they evaluate hip and knee implants, for example.
6.   Section 3041:  Reducing Transparency in the Sunshine Act for Physicians Payments
We are glad that Congress previously required companies to make public their payments to physicians.  That law helps patients know if their doctors have a financial relationship with a company that makes a drug or device that the physician is recommending.  So we are very disappointed that Congress has already proposed a loophole for fees or gifts to doctors that are intended for “continuing medical education” purposes at fancy resorts or other meetings. It also would exempt expensive gifts such as medical textbooks and journals. Although we want doctors to be up-to-date in their education, we believe doctors make enough money to buy these themselves.  
As patients and consumers from across the country, we ask you to pause before passing this bill.  You’re moving too fast on a law that will affect every single person in this country.  We deserve a better bill and a more careful review of the fine print that could save lives if done correctly, and cost many lives if it isn’t very carefully evaluated and revised.

Sincerely,

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