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

Congress is working on a bill called 21^st 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 industry.  Unfortunately, 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

www.center4research.org

www.stopcancerfund.org

NCHR Twitter / NCHR Facebook

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 21^st 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 3^rd 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,

Social Media and Patient Activists: Read this!

510(k) Under Attack

Created 02/18/2015 - 17:36

Posted in Regulatory and Compliance [1] by MDDI Staff on February 18, 2015

Regulatory and Compliance

The most common pathway to market for medical devices is coming under fire from a social media campaign led by activists determined to get FDA to ban power morcellators used in hysterectomy procedures. 

Jim Dickinson

The main portal for admission of new medical devices to the market, Section 510(k) of the Food, Drug, and Cosmetic Act, is under attack again, this time from an unlikely quarter: an unconventional and social media-driven campaign led by Philadelphia cardiothoracic surgeon Hooman Noorchashm and his wife, anesthesiologist Amy Reed.

In February, the Philadelphia Inquirer published an article by Noorchashm in its Sunday health section headlined “A modern-day wolf in sheep’s clothing: FDA’s Center for Devices and Radiological Health (CDRH) [3]”—just the latest salvo in the couple’s 18-month multimedia efforts to ban power morcellation devices used to perform hysterectomy procedures. The article opened a new front in the couple’s fight: to repeal or radically alter Section 510(k).

Their campaign began after Reed’s hysterectomy with a Karl Storz power morcellator spread cancer throughout her abdomen, joining a general one-in-350 incidence rate in power morcellation, according to FDA.

Their efforts have been remarkably successful so far, attracting congressional as well as media support and culminating last November in an uncommonly rapid FDA “immediately in effect guidance [4]” urging manufacturer adoption of a boxed warning and two label contraindications. FDA guidances by definition are nonbinding, however.

Even this small step was swiftly denounced by the American Association of Gynecologic Laparoscopists, which has renamed itself simply AAGL, at its annual meeting in Vancouver, where it declared power morcellation “an effective, lifesaving tool in gynecologic surgery when used appropriately” that “should not be abandoned despite recent concerns about the dissemination of occult cancers.”

FDA’s modest, voluntarism-based action wasn’t enough for Noorchashm and Reed, whose campaign for an outright ban so far has attracted more than 87,000 signatures on a cyber petition [5] to end the devices’ use in all gynecological procedures.

They also want Section 510(k) itself repealed or amended to include a proof-of-safety requirement and a rigorous postmarketing surveillance requirement.

In February, their local Congressman, Republican Mike Fitzpatrick, was preparing a bill to do just that, according to Noorchashm (at press time, Fitzpatrick’s office had not responded to my request for confirmation).

FDA’s implementation of 510(k) has plenty of deficiencies. Five years ago, there was the memorable tumult over the collagen scaffold which, after two years of controversy and corrupt CDRH review allegations, the agency was forced to admit should never have been cleared for marketing [6].

As in the power morcellator case, a key and recurring theme is 510(k)’s gaping loophole on what “substantially equivalent” really means. Both devices were only vaguely similar to their predicates, and predicate-creep over years and even decades without any second look at safety documentation for new-technology products is a disconnect that should be obvious.

Not if there’s market millions to be made in that disconnect, and in user-fee funds (currently $5018 per submission) to be garnered at FDA. This combination understandably brings with it a certain degree of elasticity in “substantial equivalence” determinations by a CDRH that has come to regard product sponsors as “customers.”

When further combined with industry campaign support for candidates of both parties, this fiscal interdependency arguably enabled both Congress and FDA to ignore or dismiss a recommendation in the 2011 Institute of Medicine [7] report on 510(k) that the agency’s 510(k) program be scrapped.

In its place, the report said, should be a new regulatory framework for Class II devices that is not based on “substantial equivalence” but rather on an “integrated premarket and postmarket regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”

The collagen scaffold and power morcellator controversies haven’t been the only storms to rock FDA’s 510(k) boat, and they likely won’t be the last. The IoM report cited safety issues with an artificial hip, surgical mesh, and medical-tubing connectors, among others.

In Noorchashm’s opinion, and that of former FDA medical device compliance director and noted device attorney Larry R. Pilot—a fierce defender of 510(k) which he helped write—a major issue is the quality of CDRH’s management, processes, and culture.

Noorchashm and other critics fault the center for “being in bed” with industry, while Pilot and others fault it for “incompetence” and failure to use the tools available to it to resolve problems.

These are legitimate issues, but they’re unlikely to be easily eliminated because they are deeply rooted in the very nature of government, across the board, in the American political system. Stakeholders have to be heeded, and the more money they have, the more they have to be heeded.

This is a dynamic that may be about to undergo radical change—something that Noorchashm and others representing injured patients are counting on.

Social media have given them potent tools they never had before. People-power is evolving as a key factor in government decisionmaking. FDA’s timid action on power morcellators came as swiftly as it did largely because of the effectiveness of Noorchashm’s skillful, even adroit multi-media efforts, especially after the Wall Street Journal [8] promoted them. He also credits FDA associate commissioner for policy and planning Peter G. Lurie [9]’s active cooperation.

Social media are changing everything. As mainstream media struggle to adjust, print yields to digital, and Twitter and Facebook replace the evening news, health activists representing injured patients and their families will eventually truncate FDA’s fossilized internal processes, gain seats at the table, and counter the heavy, hidden hand of the influence peddlers.

It’s coming faster than you might think. President Barack Obama’s widely reported initiative on precision medicine [10] actually would enlist “a million or more Americans to volunteer to contribute their health data to improve health outcomes, fuel the development of new treatments, and catalyze a new era of data-based and more precise medical treatment.”

The million or more may be expected to become much more interested, if not activists, in patient care technologies and their governance.

The precision medicine initiative aims to recruit collaborative public and private efforts to “leverage advances in genomics, emerging methods for managing and analyzing large data sets while protecting privacy, and health information technology to accelerate biomedical discoveries.”

Whether or not a Republican-controlled Congress goes along with this initiative—and there are signs that it might—FDA and industry’s old ways of doing things in Washington, DC, and at grassroots are already undergoing seismic change.

A grassroots challenge to 510(k) could be just a beginning. For those with long memories, it was a gynecological device, the Dalkon Shield IUD, and injured patient activism that fueled much of the legal and public agitation that led to the 1976 Medical Device Amendments and the enactment of Section 510(k).

The new patient-powered insurgency could be at least that effective, this time around.

Jim Dickinson is MD+DI's contributing editor. 

ESSURE harmed women speak at FDA on January 14: Please donate!

UPDATE 1/12/2015  FiDA Highlight

http://www.youcaring.com/other/essure-problems-in-washington-dc/280452

$3,526

raised of $3,965 goal

ends

in a day

http://www.classaction.org/blog/the-case-against-essure

The Case Against Essure

Jan 9, 2015 Kevin Pflug
Defective Medical Devices

Normally, when a company sells a defective product, those who have been injured may file lawsuits seeking compensation for the harm they have suffered. For women who have experienced serious medical complications because of the birth control device Essure, the courthouse doors have been closed. A legal doctrine known as federal preemption has prevented injured patients from filing lawsuits against Bayer, the maker of the medical device.

Last year, a woman filed a lawsuit in Philadelphia challenging the application of federal preemption to Essure lawsuits, alleging that the doctrine should no longer apply to Essure. If the case is successful, it could pave the way for other Essure victims to file lawsuits seeking compensation for their injuries.

What Is Federal Preemption and What Does It Mean For Those Harmed by Essure?

Federal preemption is a legal doctrine derived from the Supremacy Clause of the United States Constitution. Under the Supremacy Clause, federal laws may supersede any inconsistent state laws or regulations. For a federal statute to preempt state law, however, Congress must draft the law to specifically state that it preempts state regulation.

While the federal law governing medical devices, the Medical Device Amendments Act of 1976, contains a preemption clause regarding state regulation of medical devices, the preemption provision does not expressly prohibit lawsuits based on state law tort claims, such as negligence or breach of warranty.  

In 2008, the Supreme Court ruled in the case of Riegel v. Medtronic that the preemption provision of the Medical Device Act prevents injured patients from filing lawsuits based on state law claims involving certain medical devices that have received premarket approval from the FDA. Thus, women who have been harmed by Essure have been unable to file lawsuits against Bayer. This prohibition seems particularly unfair and arbitrary, especially in light of the fact that there is no such limitation on lawsuits involving FDA-approved prescription drugs or other types of medical devices that are cleared by the FDA under its 510(k) program.

Following the Supreme Court’s decision in Riegel v. Medtronic, Inc., the New York Times published an editorial titled “No Recourse for the Injured” decrying the Court’s decision, observing that:

Justice Scalia’s faith in the F.D.A. far outstrips our own. The supposedly expert and rigorous reviewers at the F.D.A. are hardly infallible. They may approve marketing of a device based on questionable evidence and they are notoriously derelict about removing dangerous products once they are on the market.

Moreover, the New York Times reported that when Congress passed the Medical Device Amendments Act in 1976, it did not intend for the law to deprive injured patients of their right to sue medical devices makers:

When it passed the 1976 law, Congress almost certainly had no intention of removing the right to sue. Senator Edward Kennedy, the Senate sponsor of the law, and Representative Henry Waxman, who sat on the House panel that approved it, have both said that Congress had no intention of granting the manufacturers immunity from lawsuits over injuries caused by their devices.

Despite criticisms from the New York Times and others, federal preemption of lawsuits involving certain medical devices remains the law of the land. Unless a judge rules that FDA premarket approval of Essure should be invalidated, Essure victims will be unable to seek compensation from Bayer.

Bayer Failed to Report Essure Problems, Misled FDA

Although the Supreme Court’s ruling made it nearly impossible to successfully sue a manufacturer who made a defective product that the FDA approved, the Supreme Court also ruled that a medical device that has received premarket approval must be manufactured and marketed with almost no deviations from the specifications set forth in the FDA approval application.

In May of last year, a Florida woman filed a lawsuit against Bayer alleging that federal preemption should no longer apply to Essure lawsuits because the company misled the FDA about the safety and effectiveness of Essure and created a dubious marketing scheme that gives doctors a financial incentive to push the product on patients.

The lawsuit alleges that the FDA’s Conditional Premarket Approval (“CMPA”) of Essure became invalid because of Bayer’s failure to comply with the terms of the CPMA order. As a result, Bayer’s CPMA is “invalid and its adulterated product, Essure, should never have been marketed or sold.”

Under the FDA’s Premarket Approval Process, devices can either be “approved,” “conditionally approved,” or “not approved.” The FDA conditionally approved Essure, meaning that the device could be marketed and sold in the United States as long as Bayer complied with a specified list of conditions. One of those conditions requires Bayer to report to the FDA whenever it receives information that reasonably suggests that the device may have caused or contributed to a serious injury. In addition, the FDA conditional approval requires that Bayer’s representations and warranties regarding the safety and effectiveness of Essure must at all times be “truthful, accurate, and not misleading.”

According to the lawsuit, the FDA’s conditional premarket approval of Essure is invalid because Bayer has failed to comply with the conditions set forth in the premarket approval of the device by:

1. Failing to report and actively concealing perforations that occurred as a result of Essure
2. Erroneously using non-conforming materials in the manufacture of Essure
3. Manufacturing Essure at an unlicensed facility

As alleged in the lawsuit, Bayer “actively concealed these violations” and had the plaintiff known that Bayer “was concealing adverse reactions, not using conforming material approved by the FDA, not using sterile cages, operating out of an unlicensed facility, and manufacturing medical devices without a license to do the same, she never would have had Essure implanted.” Failure to comply with just one of the FDA’s conditions could invalidate the CPMA Order.

If the court agrees with the plaintiff’s allegations that Bayer has failed to comply with the FDA’s conditions, the company would no longer be able to claim that Essure lawsuits are preempted by federal law. 

Essure victims may also be able to allege that the FDA’s premarket approval of the device should be invalidated because Conceptus (the company that originally designed Essure and is now owned by Bayer) misled the FDA by failing to report the negative side effects of at least one woman who participated in a clinical trial that the FDA relied upon in approving Essure. The woman who participated in the Essure clinical trial told NBC News that she experienced severe pain that made it difficult to breath and have intercourse; however, the studies that Conceptus submitted to the FDA did not include reports of these adverse reactions. Instead, the company told the FDA that “comfort was rated as good to excellent by 99% of women.”

What Is Essure?

Essure is a permanent birth control device for women. Approved by the FDA in 2002, Essure has been implanted in more than 750,000 women worldwide. Its popularity can be attributed in part to Bayer’s aggressive advertising campaign, which touted the device as “the only non-surgical, permanent birth control available.”

The medical device is a four-centimeter, micro-insert that is placed in the fallopian tubes and prevents pregnancy by causing severe inflammation that is intended to create a total and permanent blockage of the fallopian tubes. Essure’s micro-inserts are comprised of an expanding coil made of a stainless steel inner coil, a nickel Titanium (nitinol) expanding outer coil and polyethylene (PET) fibers. After placement of the coils in the fallopian tubes by Bayer’s disposable delivery system, the micro-inserts expand upon release and anchor into the fallopian tubes. The PET fibers cause inflammation in the fallopian tubes, causing scar tissue to form over the coils, thus blocking fertilization.

On its website, Bayer claims that Essure “works with your body to create a natural barrier against pregnancy.” This statement would be true if your definition of “natural” included the use of plastic fibers to cause severe inflammation and the formation of scar tissue.

Many of the women who experience severe pain after being implanted with Essure may unknowingly be allergic to nickel, a metal used in the device. According to news reports, the FDA originally advised doctors to have their patients undergo a test to determine if they were allergic to nickel before being implanted with Essure, but Conceptus asked the FDA to remove this requirement several years ago. Recent studies have found that ten to twelve percent of women may be allergic to nickel.

Essure Can Cause Serious Medical Complications

Although Bayer claims that serious complications caused by Essure are “rare” and that the device is over “99 percent effective at preventing pregnancy,” these assertions are undermined by the actual experiences of thousands of women across the country who have either experienced debilitating chronic pain or became pregnant after being implanted with Essure. In fact, Bayer’s Essure celebrity spokesperson, Olympic skier and gold medalist Picabo Street, became pregnant after being implanted with Essure. She is no longer a spokesperson for Essure.

Two years after being implanted with Essure, the plaintiff who filed that lawsuit was hospitalized multiple times due to severe pain, fever and fainting spells. Eventually, a CT scan revealed that one of the micro-inserts had migrated from the fallopian tube and became lodged in or behind her colon. It was also discovered that there were three micro-inserts inside the plaintiff (instead of two) because the doctor attempted multiple times to successfully implant the device. The plaintiff eventually underwent a complete hysterectomy and an additional surgery to remove the coil lodged in her colon. According to the lawsuit, she now suffers from several autoimmune and adhesion disorders.

The lawsuit alleges that Bayer did not adequately train the plaintiff’s doctor on how to properly implant Essure. According to the lawsuit, the plaintiff’s physician told her that a representative from Bayer would be present to supervise the procedure. Bayer’s representative allegedly failed to attend and supervise the procedure and it took the implanting physician several attempts to successfully implant Essure in the plaintiff.

Furthermore, the lawsuit alleges that, “the skills needed to place the micro-inserts as recognized by the FDA panel are way beyond the usual gynecologist.” Bayer’s own experts in hysteroscopy (as compared to general gynecologists not on the same level as an expert) allegedly failed to place the micro-inserts in 1 out of 7 clinical participants.

Bayer Gave Doctors Financial Incentive to Push Essure

Doctors who want to implant Essure in patients must have specialized hysteroscopy equipment in their offices to insert the device. As part of Bayer’s Essure marketing program, Bayer provided this hysteroscopy equipment to doctors free of charge. In exchange, the doctors who receive the free equipment must agree to purchase two Essure kits a month from Bayer, regardless of whether he or she has patients that month who actually want the device.

According to the lawsuit, this marketing scheme is an “unreasonably dangerous distribution plan” that was “aimed at capitalizing on and monopolizing the birth control market at the expense of the plaintiff’s safety and well-being.” In addition, the lawsuit alleges that this distribution plan created an environment that “induced the implanting physician to push Essure to patients.”

Essure Victims Organize Online to Raise Awareness

If the court agrees with the plaintiff’s allegations and finds that Bayer has failed to comply with the conditions of the FDA’s premarket approval of Essure, the lawsuit may pave the way for thousands of other women to sue Bayer for their injuries.

In the meantime, thousands of women across the country have turned to social media to raise awareness of the controversy surrounding Essure. For example, a Facebook community page called “Essure Problems” has more than 4,500 likes and the “Essure Uncensored” page on Twitter has nearly 1,500 followers. 

In addition, environmental activist and consumer rights advocate Erin Brockovich has created a website to educate the public about the dangers of Essure. Ms. Brockovich recently appeared on HuffPost Live to speak out against Essure.

According to the Cincinnati Enquirer, Bayer has no comment regarding the social media campaign against Essure. In a thinly-veiled denial, a statement released by Bayer reads: “We are saddened to hear of any serious health condition affecting a patient using one of our products, regardless of the cause.”

Undeterred, Essure victims are taking their fight to the FDA. On January 14, several members of the online group Essure Problems will meet with FDA representatives in Washington, D.C. to urge the agency to rethink its approval of Essure. The group is currently seeking donations to fund its trip to Washington.

DONATE HERE!           FiDA highlight

This fundraiser is to help with expenses to send six Essure Problems group administrators to Washington, DC for meetings to address Essure, it's safety and effectiveness, the FDA's role in Essure, and ultimately to impress upon those there that Essure needs to be removed from the market.

$1,712raised of $3,182 goal with 5 days remaining   DONATE HERE!85 donors

Updates

12/31/2014

by Carrie Hirmer

From admin Amanda Dykeman: 

I just received a call from Ben Fisher, Director, Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation in the FDA.  WE LANDED OUR MEETING IN FRONT OF THE FDA LADIES!! We have 1 hour on the floor in front of the new CDRH ombudsman, staff that has prior experience with essure, and staff from the office of device evaluation and compliance!! On January 14, at 9:30 am tentatively we will finally have our time to shine!!!!  DONATE HERE!

12/30/2014

by Carrie Hirmer

With your help, we are almost 1/4 of the way to our goal!  Thank you for your faith and trust in us and for allowing us to be your voices!

We want to show key lawmakers and other decision-makers in DC the issues faced by not only the women with Essure, but also the impact it has on the family unit as a whole.  DONATE HERE!

Your generosity and support has been amazing so far, but we still have a long way to go.  Please continue to support our efforts and share with others you think might be interested in supporting us as well.  We will not rest until the facts about Essure are known and your voices are heard!

The FDA restricts harmed patient access to speak by limiting the number of meetings and locating the meetings far from hotels and public transportation.  These women are risking their health and stretching family finances to fight for something that the government promised to do:  only clear safe and effective medical devices.  Please donate to show your support for their mission.  Any amount will do that.  

Estimate of travel costs

Hotel: $160/night

Flight:  $200 RT

Transportation: $60

Food: $40

Total:  $460/pp per day

Apply for this Patient Advocate Scholarship by November 1

 Apply for a scholarship to the 2013Lown Conference!    FiDA highlight

We are excited to announce that we have scholarship funding to help bring  medical students, residents, nurses and nursing students, community organizers, civic leaders, patients, and patient advocates to the 2013 Lown Conference - apply now! 

The conference is happening on Boston on December 3rd and 4th. You should read the full program, but here’s a refresher on the major goals of this year’s conference:

•               Creating a new conversation among clinicians, patients, and civil society about the purpose of medicine and the health care system

•               Understanding overuse as a moral and spiritual problem

•               Recognizing that a better world is possible

•               Envisioning health and health care 25 years from now.

We will also have working group meetings on December 5, the day after the conference, covering Medical Education, Public Engagement, International Collaboration, the Choosing Wisely campaign, and Setting the Research Agenda. If you are interested in participating in one of these working groups, please email us for more information at info@lowninstitute.org, and watch this blog for more details on the different working group agendas!

If all of that sounds exciting and informative, but you’re unsure of how to pay for travel, this is your opportunity! The scholarships will provide reimbursement (up to $1200) to cover travel and lodging for the conference. We are committed to using these scholarships to bring a wide range of voices and perspectives to the conference, and we know it will be a better event with representation from all groups concerned with reducing overuse in medicine.

If you’re interested, apply here by 5pm Eastern time on November 1, 2013. (That’s only two weeks from tomorrow!) We are only able to offer a limited number of scholarships, but will accommodate as many applicants as possible. We will notify recipients by email.  

And finally, please share this information with your colleagues, students, and anyone else who you think would benefit from participation in what promises to be an incredible conference!

Mayo Social Media Residency discounts for Patients/Caregivers

Lee Aase (SMUG) presents! 

Posted on August 28th, 2013 by Farris Timimi

FiDA highlight

Patient/CaregiverDiscounts for Social Media Residency

The mission of the Mayo Clinic Center for Social Media is to lead the social media revolution in health care, contributing to health and well being for people everywhere.

Providing training for those interested in applying social media tools to promote health, fight disease and improve health care is essential to that mission. Our major training program is Social Media Residency, a 1.5-day in-depth course that offers practical, hands-on learning opportunities in a strategic context. The regular registration fee for Social Media Residency is $795, although members of the Social Media Health Network receive a 25 percent discount.

The course is primarily intended for those who want to use social media professionally and who need not only training in the tools but also assistance in clarifying a strategic plan and guidance in making the arguments for social media adoption within their organizations.

We want to give voice to patients and caregivers and help them in their use of social media, too, but we understand that most would have difficulty affording even the Network member rate for Social Media Residency.

To make this training more accessible and affordable, we have established a special discounted rate for patients and caregivers. Those who don’t work for health-related organizations (or for agencies with health care clients) are eligible to register for Social Media Residency for $195, saving $600 off the regular rate.

The discounted rate applies for Social Media Residency courses beginning with Sept. 10-11 in Dallas, and including Oct. 21-22 in Rochester, Minn. and Nov. 4-5 in Jacksonville, Fla.

To get this special rate, use the discount code PATIENT when registering for Dallas or Jacksonville.

We will be giving instructions for the Rochester session in a separate post, as we will have patient/caregiver discounts for all three events in Social Media Week.

We hope this special $195 rate for Social Media Residency will enable many more patients and caregivers to participate.

Farris Timimi, M.D., is the Medical Director for the Mayo Clinic Center for Social Media and the Social Media Health Network.

Follow-up:  my homework assignment was to post a blog and include a link

http://socialmediaresidencyblog.mayoclinic.org/discussion/patients-in-the-room

Patients in the Room

Patients historically were not present or were the minority in the room at medical conferences, but this is changing.  Many medical professionals are embracing this transition to "Patients Included"  for the benefits it brings to patient safety and improvement in the trust model between patients and providers.  This should be a natural for medical caregivers:  patients are the "customer" or "consumer" of services.  There is no middleman.  The discussions can be difficult and honest and will also expose the respect for care-taking professionals and commonality of experience.  Take ePatient Dave's recent post about "Ratty Boxers" asking for his/patient representative/patient advocate costs to be covered when serving as a Patient Advocate at medical conferences. His presence at conferences adds value and deserves to be valued by the medical system if it wishes to credibly maintain the moniker:  patient-centered.  Invite patients into the conversation and make sure they are not made to run around in Ratty Boxers!   Just ask!  It is part of the care-giving model.  Check out my blog for more discussion and you will see that patient engagement is not just about the bad food in the hospital . . .

Sunshine Act exemption is a missed opportunity to fund/include patients at medical conferences.

Doctors Face New Scrutiny Over Gifts

New Health Law Calls for Increased Disclosures

            By PETER LOFTUS CONNECT  Wall Street Journal

FiDA highlight added

U.S. doctors are bracing for increased public scrutiny of the payments and gifts they receive from pharmaceutical and medical-device companies as a result of the new health law.

Starting this month, companies must record nearly every transaction with doctors—from sales reps bearing pizza to compensation for expert advice on research—to comply with the so-called Sunshine Act provision of the U.S. health-care overhaul. The companies must report data on individual doctors and how much they received to a federal health agency, which will post it on a searchable, public website beginning September 2014.

Many doctors say the increased disclosures are making them rethink their relationships with industry, citing concerns about privacy and accuracy, and worry that the public will misinterpret the information. Some fear patients will view the payments as tainting their medical decisions, and will lump together compensation for research-related services with payments of a more promotional nature.

Drug companies collectively pay hundreds of millions of dollars in fees and gifts to doctors every year. In 2012, Pfizer Inc., PFE +0.64% the biggest drug maker by sales, paid $173.2 million to U.S. health-care professionals. Some companies including Pfizer have decreased these payments in recent years; Pfizer's total was $195.4 million for 2011.

Consulting and speaking fees are an important source of income for some physicians, who can be paid tens of thousands of dollars a year for such services. But now physicians say they will be much more selective about the work they do and what they will accept from industry representatives. Some are even restricting access to their offices by sales reps, or requiring forms that document the value of anything brought to the office, according to medical societies.

John Mandrola, a cardiologist in Louisville, Ky., said he has been paid a total of $1,500 to $2,000 this year by medical-device makers for speaking engagements. Knowing that such transactions will become public has caused him to be more cautious about what fees to accept, he said. He avoids industry reps visiting his office, believing he can get information on new drugs elsewhere.

"I'll continue to weigh the benefits and the negatives, and I think the Sunshine Act and the public reporting of all this stuff makes us think about that," said Dr. Mandrola. "And I think that's a good thing."

A benefit of transparency, Dr. Mandrola said, is that it will help doctors evaluate medical research from peers if they know whether the researchers receive payments from certain companies. Still, he worries that the disclosures could squelch legitimate interactions—for example, when doctors receive consulting fees to help companies develop drugs and determine their best use.

"I don't think all physician-industry interaction is bad," he said.

The push for greater transparency was driven by concerns that doctors' prescribing decisions are tainted by the payments and gifts, as well as allegations that drug companies have used payments to induce doctors to prescribe drugs for unapproved, "off-label" uses. Several drug companies have paid large penalties to settle government allegations of off-label marketing, and were required to disclose physician-payment data as conditions of the settlements.

"The idea is that transparency will encourage doctors to evaluate whether these are appropriate relationships with companies or not," said Daniel Carlat, a psychiatrist and director of the prescription project at the Pew Charitable Trusts, which supported the Sunshine Act. He expects patients won't have much of a problem if their doctors receive $200 worth of company-provided lunches, but may question doctors who receive tens or hundreds of thousands of dollars from the industry annually.

Several drug and device makers—including Pfizer and Eli Lilly LLY +0.30% & Co.—have been posting physician-payment data online for the past few years. Some U.S. states already require companies to report such information. But the Sunshine Act will significantly widen the scope because it applies to most companies—any company whose products are covered by Medicare—and the government's launch of the database could draw greater public attention.

Richard B. Aguilar, a diabetes-care specialist, received a total of $42,339 from Lilly for the first three months of 2013, according to Lilly's online payment database. Dr. Aguilar, who has a private practice in Downey, Calif., said he speaks about Lilly drugs at programs to teach other doctors, and the information is consistent with the FDA-approved prescribing labels. He says the payments are fair compensation for his expertise and travel.

Dr. Aguilar plans to continue serving as a paid speaker, but he says other doctors are increasingly opting out of attending or speaking at such programs for fear of what the public will think about the payment disclosures.

Dr. Aguilar said he hopes the public would see the value of physicians learning new information about drugs from an expert at speaker programs, rather than having to rely upon their own educational resources to keep current. "This, in essence, is reducing the number of valuable expert educational speakers who might otherwise have provided teaching and experience to many health-care providers," he said.

Some doctors fear the payment data will be inaccurate and could mislead the public about the nature of their relationships with the industry. Gary M. Cowan, an ophthalmologist in Fort Worth, Texas, said he has occasionally attended company-sponsored dinners to hear a lecture from an expert in his field. He plans to monitor the payments that companies report in his name.

"I think it behooves every physician to look and see what's said about him," he said.

Drug makers said they've been preparing for the new reporting requirements and have implemented technology systems to collect the data, but they will continue to work with physicians because the interactions improve science and medicine.

The Centers for Medicare & Medicaid Services, which is implementing the Sunshine Act, is advising doctors to keep records of all payments and transfers of value received from industry. Once the agency receives payment data from manufacturers, it will give doctors about two months to review the data and work with companies to make any corrections before it is made public.

CMS also will break down the payment data into more than a dozen categories—such as meals, travel, research or speaking fees—to give a clearer idea of the nature of a doctor's relationship with industry.

One key exemption: Companies won't have to report compensation to doctors who speak at certain accredited events where physicians receive continuing medical education—as long the sponsoring company doesn't select or directly pay the speaker, but rather delegates those duties to a third-party organization. CMS initially proposed to require that such payments be reported, but granted the exemption in its final rule issued earlier this year, saying industry support for accredited or certified continuing medical education is a "unique relationship." Continuing-medical education providers pushed for the exemption, arguing that industry support would dwindle if the payments had to be reported.

Stefanie A. Doebler, an attorney with Covington & Burling LLP who represents health-care companies, said the exemption for indirect payments to speakers at continuing-medical education events could help sustain industry support for such programs. However, companies will be required to report certain other expenses for these programs, such as meals provided to physician attendees if the cost of each meal is separately identifiable. Some companies have decided not to fund such meals, she said, which could cause program providers to charge attendees for the meals.

To ensure accuracy, CMS is required to conduct audits of the data submitted and levy civil monetary penalties against companies for failing to submit data, or for submitting inaccurate data. Companies that fail to report information in a timely, accurate or complete manner face penalties of at least $1,000 per transaction, with a total maximum annual penalty of up to $1.15 million per company, according to CMS.

CMS plans to publish the data each year on a public website starting in the fall of 2014. CMS says patients will be able to look up their doctors and see if they have any financial relationships with companies, which types of payments they receive and how much.

Some companies are taking steps to prepare the doctors with whom they do business. Later this year, Roche AG's RHHBY -0.06% Genentech unit, which sells the cancer drug Avastin, will launch an online portal called "Sunshine Track," which will allow doctors to review payment data before it is reported to CMS. "We have implemented extensive processes to validate all payment information we collect," said a spokeswoman.

Genentech also allows physicians to opt out of receiving meals from the company at speaker programs or during office visits by sales reps. Doctors opting out of meals at speaker programs must certify this on a sign-in sheet and can either pay for the meal themselves or not partake, the spokeswoman said.

Write to Peter Loftus at peter.loftus@dowjones.com

Joleen Chambers comment:

More empty talk about being patient-centered:  with the exemption allowing industry to support medical education through a third party, the legislation FAILS to include a % of the funding to go to consumer organization scholarships making participation in the conferences possible.  Treatment decision makers and healthcare system designers are notorious for ignoring the patient stakeholder!   Engaged patient advocates are otherwise unfunded and pay a big price to compete for conference slots competing with those with professional credentials and a sponsoring organization.