Testimony Before Maryland Senate Regarding the Dangers of Artificial Turf

Testimony Before the Maryland Senate
Budget and Taxation Committee

March 7, 2018

I am Jack Mitchell, speaking on behalf of members of the Patient, Consumer, and Public Health Coalition, which represents millions of patients, consumers, and public health advocates across the country.

We strongly support SB 0763, which would prohibit the use of state funds for artificial turf fields and playgrounds. At the House hearing on the companion bill, HB 505, I heard testimony from individuals who misrepresented the evidence regarding the safety of recycled tire material, other synthetic rubber, and other synthetic materials on playing fields and playgrounds.

The bottom line is that these products have never been proven to be safe and there is no federal agency – not EPA, not Consumer Product Safety Commission, etc, who has ever concluded that they are safe. On the contrary, federal agencies have either ignored the issue or have reviewed existing research and found it to be inconclusive.

When our children’s health is involved, should we be saying artificial turf is OK as long as it hasn’t yet been proven to cause serious harms? Should the state of Maryland spend millions of dollars to install artificial turf fields and playgrounds that could be causing cancer, obesity, early puberty, asthma, and attention deficit disorder? I don’t think so.

These products are not proven safe.

If anyone tells you these products are safe, please ask if they have any financial or personal ties to companies that make or install artificial turf.

One of our members is the National Center for Health Research, and they have reviewed all the published studies and concluded that none of these products have been declared safe for constant exposures – in fact, there are no state or federal laws that require evidence of safety for long-term use.

The EPA and the Consumer Product Safety Commission have been studying the risks, Unfortunately, their work has been delayed and limited by the lack of unbiased research about the risks of the products being sold. Independent researchers at Yale, Columbia University, and California’s environmental health agency have conducted excellent studies. This has resulted in some clear evidence of the harms of crumb rubber, but less information about other materials used in artificial turf.

During the Trump Administration, we can’t expect that any federal agencies will produce an unbiased report on the topic. However, we know that artificial turf is made from chemicals that disrupt hormones, and some of those types of chemicals are banned by Federal law from toys and other products for young children.

Chemicals banned from rubber duckies, teething toys, waterproof books, and other products used for a relatively short period of time by children should not be allowed in playing fields and playgrounds where children are exposed day after day, week after week, and year after year.

Overview of Proven Risks

The artificial turf industry and those who listen to them will tell you that there is no clear evidence that their fields caused any child to develop cancer. That is true, but keep in mind that it took decades to prove that smoking causes cancer, and that most people start smoking as teenagers but don’t get lung cancer until 40+ years later. Even when a smoker develops lung cancer, that doesn’t necessarily mean that the smoking caused the lung cancer – it only means it increased the chances of the smoker developing lunch cancer.

With artificial turf, it could be decades before we can conclude what the exact risks are to children, but the weight of the evidence can be clear, even when the specific cause and effect can’t be proven.

In addition to artificial grass fields, rubber playground materials used to cover the ground near slides, swings, and other playground equipment are made with the same kind of tire crumb and “virgin rubber” as athletic fields and have many of the same risks. Engineered wood fiber is a much safer alternative, which is also ADA-compliant, is as effective at softening any falls and has no dangerous chemicals.

Coalition Letter to Member of Congress Regarding Regulatory Accountability Act of 2017

May 24, 2017

Dear Senator:

As members of the Patient, Consumer and Public Health Coalition, we are writing to strongly urge you to oppose S. 951, the Regulatory Accountability Act of 2017 (RAA). This legislation, which covers guidance documents and well as rule-making, has dangerous implications for the health of all Americans. The current rule-making process is much too slow as well as unduly influenced by the special interests and court challenges of regulated industries. The RAA will make this situation worse, jeopardizing public health by threatening the safeguards needed to ensure clear air and water, safe workplaces, untainted food and effective medical products, and safe toys and consumer goods.

Rather than improve the current regulatory process, the legislation would instead weaken regulations that protect the public. While we can all agree that rules should be cost-effective, that term can be defined in many different ways. Years of litigation would result. Unfortunately, the bill’s “savings clause” does not clarify who authorizing statutes would be affected by the bill’s many requirements, and so is likely to result in years of wasteful litigation.

The RAA reintroduces “formal rule-making” which involves the use of adversarial, trial-type hearings to resolve complex policy questions. Any individual could petition an agency to hold a hearing on any “genuinely disputed “scientific or factual conclusions underlying the proposed rule. This would obviously not be in the public interest. The bill would also expand the scope of judicial review. While federal agencies have technical and scientific expertise, judges who are generalists would lack the expertise required to fully understand the need for or impact of a rule. Against, years of litigation are the likely result.

We are particularly concerned that agency guidance documents would be weakened and delayed under the RAA. For example, FDA guidance documents are often needed to keep up with innovations in medical treatment. Under RAA, these guidance documents would be greatly delayed, resulting in uncertainty for companies trying to get their medical products approved, and potentially putting patients’ health or lives at risk.

In conclusion, the RAA would do more harm than good by undermining life-saving safeguards that protect the public. We strongly urge you to consider the impact on your constituent and oppose the Regulatory Accountability Act of 2017.

Sincerely,

Association for Medical Ethics

American Medical Women’s Association (AMWA)

Connecticut Center for Patient Safety

Jacobs Institute

Kids in Danger

MRSA Survivors’ Network

MISSD

National Center for Health Research

National Consumers League

National Organization for Women

National Women’s Health Network

Our Bodies, Our Selves

TMJ Foundation

Washington Advocates for patient Safety (WAPS)

WoodyMatters

The Patient, Consumer, and Public Health Coalition is an informal coalition of nonprofit organizations representing the interests of millions of patients, consumers, health-care professionals, scientists, and public health experts. The coalition can be reached through Paul Brown at (202) 223-4000 or at pb@center4research.org.

Coalition Letter to FDA Regarding UDI Numbers on Medical Devices

December 12, 2019

Ms. Jan Welsh
Office of Medical Device and Radiological Health Operations
U.S. Food & Drug Administration
Silver Spring, Maryland

Ms. Welsh:

We are writing on behalf of our nonprofit medical, public health, and patient advocacy organizations to request that the FDA reverse its policy to exempt many implantable medical devices from directly displaying a UDI number on the implant, and to institute a policy of improved record keeping and record retention. The current FDA Regulations are based largely on comments summarized in a 2013 Federal Register report (1) on this issue. Events which have transpired in the ensuing years have negated many of the comments that the implantable medical device UDI exemption were based upon.

Major subsequent developments are as follows:
• The lack of portability and transferability of electronic medical data.
• The large number of failures requiring explantation for certain classes of medical devices, such as prosthetic hip implants, breast implants and Implantable Cardioverter Defibrillators.
• The delayed failure rate that sometimes can be many years for certain classes of implants.
• The increased emergence of counterfeit implants, which have increased failure and complication rates.
• Technology for placement of an UDI on implantable devices.
Because of these critical safety issues, we have serious concerns about the current exemption policy as well as concerns about the integrity and retention of UDI records. We make the following recommendations to improve post-market surveillance on medical devices.

1. Evidence that conflicts with one of the basic assumptions that underlay the exemption policy.

It was stated as follows in the 2013 Federal Register: “We also acknowledge the common practice of recording information about implanted devices both in the patient’s health record, and on a card provided to the patient, and we expect health care providers will incorporate UDIs into both of these types of records.”

However, at the time when many implants fail, patients have moved or transferred their care to a different provider, making access to their past medical record problematic. The lack of portability of electronic medical record data from one healthcare provider to another produces a significant roadblock in locating an implant’s UDI. In addition, in our experience the majority of patients are not given written material which identifies the implant device, with or without a UDI.

Recommendation #1: Require that manufacturers provide the patient with a card containing information regarding the implant, including the implant’s name, manufacturer and UDI, become a regulatory requirement.

Patient engagement in healthcare is of utmost importance, but healthcare literacy can vary among patients and informational cards can be misplaced. Thus, other records of an implant’s UDI must also exist.

2. Varying State Requirements for Record Retention
Of the 50 states, District of Columbia and Puerto Rico, only two have mandates to preserve records for 30 years or greater the remainder are 11 years or less. Seven states having no mandates.(2) See figure below.

Because of lack of EMR portability a facility’s contracting with a new EMR provider may require considerable resources to transfer records and old records may become lost.

State mandates for Physician record retention are even less rigorous. Federal record retention requirements (Title 21, Part 821.60 Subpart D) applies only to manufactures and distributors (Title 21, Part 821.25 and Part 821.30 Subpart B). There is not a requirement of manufacturers and distributors to collect patient or facility data, only data regarding the physician.

Recommendation #2: To overcome this problem, manufacturers and distributors record and maintain information of the facility in which a device is implanted in a patient; and that facility (surgery centers, hospitals, etc.) should retain records of all UDI’s for implanted devices for as long as a device is in use, or for 10 years after it is explanted, returned to the manufacturer or the patient dies.

3. Deletion of Records After an Adverse Event

Unlike other medical records, it appears that Sec 821.60, Subpart D allows “persons” to erase UDI records after a severe adverse event takes place. The regulation reads: “For example, a record may be retired if the person maintaining the record becomes aware of the fact that the device is no longer in use, has been explanted, returned to the manufacturer, or the patient has died.” Although “person” is not defined in the Definition Section 821.3. In Section 821.3, manufacturers are referred to as a “person” and this provision could also apply to distributors, facilities and physicians.

Recommendation #3: We strongly recommend that Sec 821.60, Subpart D, should be amended in a similar manner for record retention 10 years after an implant is explanted, returned to the manufacturer or patient death. Otherwise these is no requirement for the retention of a failed implant, a loss of information that will have an adverse impact on effective post market monitoring of implant safety.

4. Direct Marking of Implants is Crucial
In the 2013 Federal Register, it was noted “that direct marking of an implant would be useful only if the device was explanted; that the proposal is ‘‘substantially redundant in effect’’”… However, the UDI and model of an explant may not be readily available because of current shortcomings of electronic medical records. An increase in explantations of breast implants, hip implants, and other implants has shown the importance of including UDI markings on the implant itself.
The assertion that having the markings on an explant is not very useful conflicts with the evidence from the large failure rate and revisions which require removal of the implant for some classes of implants. In addition, this information is crucial for research centers, such as Dartmouth Biomedical Engineering Center for Orthopaedics, that study the etiology of explant failures. Although it is correct that a UDI on the implant would not help in recalls, it is of utmost importance in post-market surveillance.

5. Problem of Counterfeit Devices

Compounding this issue are counterfeit devices: A UDI on an explant could readily serve as a means of differentiating a counterfeit verses an authentic device, potentially saving the manufacturer from liability.

6. Improved Technology

For many large metal devices (e.g. joint implants) there is an inexpensive technology for placing a UDI on them (see enclosed picture). In addition, electrical or complex implants which have a casing can have an UDI placed safely inside the casing.

Conclusions

In the original UDI regulations, placing the UDI directly on the implant was considered the norm. Unfortunately, that requirement has been waived in response to manufacturers’ requests, failing to take into account the public health.
We strongly urge that the FDA require placement of the UDI directly on an implantable device unless the manufacturer can demonstrate that it will affect the safety or functioning of the implant, or if the size of the implant precludes such placement. Finally, there needs to be improved record keeping and record retention by hospitals and manufacturers, along with implant identifiable information given to the patient.

If you have any questions, please contact Dr. Kevin Kavanagh, Health Watch USAsm, at healthwatchusa@gmail.com

Thank you for this consideration,

Health Watch USAsm
Advocating Safety in Healthcare E-Sisters (ASHES)
Breast Cancer Action,
Jacobs Institute for Women’s Health
Just Call Me Ray
Medical Device Problems
The Medication-Induced Suicide Prevention and Education Foundation (MISSD)
National Center for Health Research
National Women’s Health Network
Our Bodies Ourselves
Patient Safety Action Network
Patient Safety America
TMJ Association
USA Patient Network
Washington Advocates for Patient Safety

CC: The Honorable Mitch McConnell, The Honorable Rand Paul, The Honorable Lamar Alexander, The Honorable Patty Murray, The Honorable Frank Pallone, The Honorable Greg Walden, The Honorable Rosa DeLauro

References:

1) Unique Device Identification System. 21 CFR Parts 16, 801, 803, 806, 810,
814, 820, 821, 822, and 830. Federal Register. Sept. 24, 2013 https://www.federalregister.gov/documents/2013/09/24/2013-23059/unique-device-identification-system https://www.govinfo.gov/content/pkg/FR-2013-09-24/pdf/2013-23059.pdf

2) State Medical Record Laws: Minimum Medical Record Retention Periods for Records Held by Medical Doctors and Hospitals. Healthit.Gov https://www.healthit.gov/sites/default/files/appa7-1.pdf

Comments of Members of the Patient, Consumer and Public Health Coalition on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products”

January 6, 2017
Division of Dockets Management
5630 Fishers Lane
Room 1061
Rockville, MD 20852

Comments of Members of the Patient, Consumer and Public Health Coalition on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products”

(Docket No. FDA-2016-1149)

Members of the Patient, Consumer and Public Health Coalition strongly oppose the off-label promotion of approved or cleared medical products.  There are valid reasons for doctors to consider off-label treatments, and some off-label use is common practice. However, doctors and patients should discuss the use of these off-label treatments with a clear understanding of the lack of clinical evidence, the doctor’s reasoning for choosing off-label treatment, and the risks.  Patients should have informed consent, which includes signing a piece of paper that explains the product is not approved by the FDA for the indication that the product is being prescribed for, and it also should include a discussion of what that means regarding the lack of objective evidence that the benefits outweigh the risks for most patients. 

We are very concerned that the FDA does not have the resources to adequately monitor such promotion and patients will be harmed.   Off-label promotion has one overriding goal:  to increase the use of medical products for patients and for conditions for which the product is not approved by the FDA.  It is not approved because the sponsor has not proven to the FDA that the product is safe and effective for that indication.  Without that evidence, the product can harm patients in several ways. First, patients will be more likely to be prescribed treatments that are not effective for their specific condition.  Second, patients are more likely to be prescribed treatments that are not safe for their specific condition.  And third, patients are more likely to be prescribed treatments that are more likely to harm than to help them.

It is impossible for FDA or any other agency to ensure that off-label communications are truthful and scientifically sound.  That would be a very resource-intensive task far beyond the resource capabilities that FDA possesses.     

Limiting what a company can say to only published clinical trials is not sufficient.  It would not guarantee that the information is truthful and non-misleading.  Clinical trials can be biased by design, execution, or selective reporting.  They can be published in journals without peer review or minimal standards.  Unfortunately, some journals will publish almost anything submitted.  Numerous Coalition members serve as peer reviewers, and have reported that even publication in a peer-reviewed journal does not guarantee that the clinical trial results and interpretation are unbiased and accurate.

Some medical products which look promising initially later appear less so when FDA reviewers identify major concerns with the study or data.  That critical check and balance process is why we believe in the importance of FDA and why we oppose the promotion of medical products for off-label uses.

Increasingly, FDA is approving drugs and devices on small, preliminary studies.  In the case of devices, more than 95% are not required to do any clinical trials.  Frequently, the apparently promising results of small exploratory studies or clinical experiences fail to be confirmed when tested with a larger, controlled trial.  That means that even the use approved by FDA may be less safe or less effective than was thought, making off-label promotion even riskier.

To make the situation worse, companies have few, if any, incentives to robustly test their product once it is on the market, either for its approved indication or other indications.  The companies and the lawyers they hired to speak at the FDA public meeting want to promote their products for unapproved uses so that they can sell more products. Moreover, the companies have said that they believe promotion of their products is protected as free speech.  If the medical product sponsors value free speech so dearly, why do firms that settle with patients who have been harmed by such products insist on non-disclosure agreements that make it impossible for those patients to exercise their own free speech and share information with other patients and their physicians? 

There is little incentive for medical product sponsors to disseminate research results which show that their products do not work, so that information rarely sees the light of day.  It’s not difficult to find cases on the Internet where a product worked for at least one patient. However, conversely, it’s not easy to find where patients were harmed, because that information is rarely published or disclosed.

Medical product manufacturers have a history of using misleading information to promote off-label uses.  These practices are rampant in the pharmaceutical industry. Almost all of the major drug manufacturers have been involved in lawsuits for improper off-label marketing tactics.  Collectively, they’ve been fined hundreds of millions of dollars. These hefty fines and legal settlements have apparently not discouraged off-label promotional violations, and neither the FDA nor the Justice Department have been able to curtail these abusive practices.  Legitimizing off-label promotion in the medical device arena will make these abuses even worse.

Some argue that FDA should allow off-label promotion, as long as the agency ensures that the information is “scientifically sound, responsibly presented, and provides as full an understanding as possible about the limitations of available evidence.”  That sounds good, but apparently assumes that the research results that the sponsor is distributing are truthful and accurate, and not distorted by selectively reporting information, or has serious flaws that may not be made clear to readers. That is not a safe assumption to make.  

In summary, we strongly oppose allowing companies to promote medical device products for off-label uses.  There are not adequate safeguards to allow such promotion to be limited to only scientifically sound, complete and unbiased data.  While some patients are helped by off-label uses, many also are harmed by the same poorly-regulated practices. Our concern is that expanding off-label promotion to medical devices will increase the number of those patients harmed.

When companies submit data to the FDA, agency reviewers have the expertise and responsibility to review those data.  That is an essential part of the process. Allowing off-label promotion conflicts with that process at the same time it removes an important incentive for companies to complete high quality clinical trials for new indications.

Thank you for the opportunity to present the views of the Coalition.  The under-signed member organizations of the Coalition represent many thousands of physicians, medical experts, patients, and advocates.

American Medical Student Association

American Medical Women’s Association

ASHES (Advocating Safety in Healthcare E-Sisters)

Association for Medical Ethics (AME)

Association for Pelvic Prolapse Support

Breast Cancer Action

Center for Medical Consumers

Community  Catalyst (MA)

Connecticut  Center for Patient Safety

Consumer Federation of America

Consumer Reports

Consumers Union of Texas

Consumers Union of Washington, DC

CUE

Essure Issues

Institute for Ethics and Emerging Technologies

Jacobs Institute of Women’s Health

Kids in Danger

Medshadow Foundation

MISSD (Medication-Induced Suicide Prevention & Eduction Fund in Memory of Stewart Dolin)

Mothers Against Medical Error

MRSA Survivors’ Network

National Alliance for Hispanic Health

National Breast Cancer Coalition

National Center for Health Research (NCHR)

National Committee to Preserve Social Security and Medicare

National Consumers’ League

National Organization for Women

National Physicians Alliance (NPA)

National Women’s Health Network

Our Bodies Ourselves

Project on Government Oversight (POGO)

Quinolone Vigilance Foundation

The TMJ Association

Union of Concerned Scientists

Washington Advocates for Patient Safety (WASPS)

Women Heart

WoodyMatters

Statement on Behalf of Members of the Patient, Consumer, and Public Health Coalition at the FDA Advisory Committee on Vaginal Mesh

Varuna Srinivasan, MBBS, MPH, National Center for Health Research: February 12, 2019


Thank you for the opportunity to speak today. My name is Dr. Varuna Srinivasan and I am speaking on behalf of members of the Patient, Consumer, and Public Health Coalition. The Coalition includes non-profit organizations representing millions of patients, consumers, researchers, and doctors united to ensure that medical treatments are safe and effective.  The Coalition does not have paid staff and does not accept funding from any outside sources, so I have no conflicts of interest.

Our Coalition strongly supports FDA’s decision to require a pre-market approval review, including clinical trials, to determine the long-term safety and effectiveness of trans-vaginal mesh for pelvic organ prolapse repair.  These products were initially allowed on to the market as substantially equivalent to mesh used in other parts of the body, under the 510(k) approval pathway that does not usually require clinical trials or direct scientific evidence of safety or effectiveness.

Mesh devices used in the repair of pelvic organ prolapse (POP) are permanent and are made out of synthetic material that has been proven to sometimes incite a foreign body response.  It is likely to shrink over time, which can result in it degrading into the surrounding tissue making it painful as well as impossible to fix. As a result, thousands of women have reported serious injury to the FDA from surgical mesh implanted as part of POP surgeries using either the anterior or posterior vaginal compartment.

Almost 100 submissions by mesh manufacturers between 2008 and 2013 were cleared by the FDA through 510(k) processes for pelvic organ prolapse repair. Despite those decisions as well as thousands of MAUDE adverse events reports, the FDA has concluded that “the risk/benefit profile of mesh has not been well established.”[i]

Research studies included in the recent FDA literature review were designed to compare POP surgery with mesh over native tissue repair but almost all of the studies used a range of primary effectiveness endpoints, most of which followed patients for only 1-3 years and many of which did not include quality of life indicators. When comparing the safety and effectiveness of these surgeries with or without mesh, most showed that on average mesh surgeries were less safe than native tissue repair. Although the initial surgery with native tissue was somewhat less effective than initial surgery with mesh, many complications occurred within the initial months of surgery with mesh for which very little data are available on the long-term risks. The studies included in the FDA review focused on either anterior compartment repair or a combination of anterior and posterior compartment repair and because the review was not limited to studies of anterior procedures, the FDA review could not conclude whether POP surgery with mesh was safe and effective specifically for anterior compartment repair.

The data the FDA provided are not sufficient to predict whether there are some women for whom the benefits of anterior mesh POP procedures are likely to outweigh the risks.  The effectiveness summary suggests that “mesh may have ‘some’ advantage over native tissue repair for anatomic POP evaluation and reoperation”,1 but this possible advantage comes with significant risks: women who undergo POP surgery with mesh are more likely to have numerous reoperations due to serious complications such as mesh erosion and exposure.

A Cochrane review published in 2016 concluded that anterior POP surgery with mesh was not a better option than native tissue repair. They examined data on the use of different types of mesh in surgical repair of pelvic organ prolapse. The review looked exclusively at 33 randomized controlled trials that included more than 3000 surgeries, comparing traditional native tissue anterior repair versus other surgical options. Sixteen of those studies compared native repair to permanent polypropylene mesh.  They concluded that “Biological graft repair or absorbable mesh provides minimal advantage compared with native tissue repair.”[ii] The Cochrane scientists pointed out that although women who had native tissue repair had more repeated surgeries for prolapse rectification; they had a much-reduced risk of bladder injury, mesh exposure, and erosion. In summary, they concluded that the evidence does not support the use of mesh for anterior vaginal compartment repair in pelvic organ prolapse.

Concurrently, other regulatory agencies such as Health Canada concluded that POP procedures have a higher risk of complications compared to native tissue repair and mesh placed abdominally.  In December 2017, Australia removed all POP mesh products from the market after concluding that the “benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients.” 1  In 2018, the UK and Ireland placed a pause on the use of all surgical mesh placed transvaginally for POP and stress incontinence.

Meanwhile, we are still hearing from many women who have been terribly harmed by POP surgery with mesh. Many have experienced terrible, debilitating pain as a result of their initial surgery, and have undergone many additional surgeries to try to reduce the pain and regain some of their quality of life.  Due to the lack of good data, we don’t know how often that happens, but it is a very terrible outcome for those women.

The American College of Obstetrics (ACOG) and Urogynecological Society (AUGS) have stated that restricting the use of mesh would be detrimental to women for whom no other options exist.  However, they have failed to provide clear scientific evidence that for most women the benefits of the use of mesh in this surgery outweighs the risks.

We want to be clear that we are on the side of evidence-based medicine.  If specific companies can provide irrefutable scientific evidence that the benefits outweigh the risks of using mesh for POP surgery, then we will support POP mesh surgeries if patients are provided with informed consent ensuring that they know that the adverse events can result in chronic, life-changing pain.

While the FDA is focusing on how to evaluate and review post market surveillance from the 3 companies, we urge the FDA to ensure that POP mesh research must include long-term studies which have reliable and validated quality of life indicators.  Studies should include quantitative data such as number of surgeries, as well as more subjective data regarding pain, activities of daily living, and quality of life.  Studies should be randomized and potential confounding variables should be statistically controlled.  The companies should also conduct subgroup analyses aimed at determining whether certain types of patients are most likely to have benefits that outweigh the harms, or vice versa.

As a doctor, I strongly believe that doctors owe it to their patients to ensure that the devices being implanted in their bodies are safe and that adequate prior pre-clinical testing has been conducted.  I hope you will agree.

[i] US Food and Drug Administration. FDA report: Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse in the Anterior Vaginal Compartment FDA Executive Summary.Silver Spring, MD: US Food and Drug Administration; 2019. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM630949.pdf

[ii] Maher  C, Feiner  B, Baessler  K, Christmann‐Schmid  C, Haya  N, Brown  J. Surgery for women with anterior compartment prolapse. Cochrane Database of Systematic Reviews 2016, Issue 11. Art. No.: CD004014. DOI: 10.1002/14651858.CD004014.pub6.


The advisory committee panel deliberated and provided input on specific questions prepared by the FDA on effectiveness, safety and patient population for the evaluation of the surgical mesh currently available on the market used for trans-vaginal POP repair in the anterior and anterior/apical compartment. The FDA 24 hour summary of the meeting and questions can be found here

Statement on Behalf of Members of the Patient, Consumer, and Public Health Coalition at the FDA Advisory Committee on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and Informed Consent

Varuna Srinivasan, MBBS, MPH, National Center for Health Research: March 26, 2019


I am Dr. Varuna Srinivasan, a physician with an MPH from Johns Hopkins, speaking on behalf of members of the Patient, Consumer, and Public Health Coalition, a group of nonprofit organizations representing millions of Americans.  We have no conflicts of interest.

FDA has been slow to recognize the full impact of BIA-ACL and needs to do more to protect women from it.

Dutch scientists first reported the association between breast implants and ALCL in 2008, but patients didn’t hear about it. It was another 3 years before FDA and the media first acknowledged the possible association between breast implants and ALCL.

The link was strengthened in 2013 with the MD Anderson Cancer Center study of 60 women with BIA-ALCL.   The next year, the NCCN released a worldwide oncology standard for physicians to test and diagnose BIA-ALCL. In 2016, the World Health Organization added BIA-ALCL to its classification of lymphoid neoplasms.

The FDA website did not acknowledge that implants sometimes cause ALCL until 2017. Before that, the vast majority of women considering breast implants were not informed about the risk of ALCL from implants, especially textured implants.

We now know that BIA-ALCL is more common than first believed.  Australia’s superior surveillance system has estimated it as high as 1 in 1,000 women with breast implants.

The delayed intervention of the FDA and surgeons everywhere on this matter is too serious to ignore.  For those women who were barely informed of these severe risks, it has had terrible and sometimes fatal consequences.

What should FDA do to help protect women from ALCL?

#1 Research indicates that at least some textured implants should be banned because they are most likely to cause ALCL.  FDA should conduct or require research to determine if the benefits outweigh the risks for any textured implants.

#2. FDA should require training for physicians and informed consent studies with breast implant patients to evaluate its success in explaining the risks. As a condition of approval, FDA should mandate that a 2-page checklist explain all the local complications, adverse outcomes, and frequently reported symptoms associated with implants in an unbiased manner at least a week before surgery. This checklist should be written by ALCL patients, researchers, and plastic surgeons. Doctors should also monitor their patients regularly for signs of ALCL.

#3 The ASPS registry should include UDI numbers, and to maximize useful information the FDA should require UDIs be printed on breast implants. In addition to reoperations and ALCL, the registry should also include information about other adverse events provided by patients, oncologists, and other physicians.

Cancer patients and augmentation patients deserve to know the risks of breast implants, the and FDA needs to ensure that happens.

Coalition Letter Opposing the “Right to Try” Law

July 31, 2017

Dear Senator:

The time is at hand for a momentous decision in the Senate which could greatly affect how patients get access to experimental drugs.  We are writing as members of the Patient, Consumer, and Public Health Coalition, representing millions of Americans, because we are very concerned about the controversial legislative measure that Senator Ron Johnson (R-WI) is trying to insert as an amendment to the Senate version of the FDA’s user fee legislation.  The User Fee bill must pass soon to avoid mandatory layoffs at the agency.

This bill, S. 204, the Trickett Wendler Right To Try Act of 2017, purports to help dying patients gain access to experimental treatments that can save their lives.  However, patients already have access to the FDA’s Expanded Access Program, which gives patients compassionate access to experimental drugs if their doctor believes it is appropriate and the company which makes the drug agrees to provide it for that use.

The Expanded Access program is not a restrictive program; FDA grants these requests more than 98% of the time.  A recent GAO report affirmed the FDA’s appropriate handling of their Expanded Access Program and outlined agency efforts to improve it and streamline its requirements for eligibility.  Also, please keep in mind that the experimental drugs provided through the FDA program are almost always free.  In contrast, Sen, Johnson’s proposal would remove FDA from the process, allow companies to charge whatever they want, not allow FDA to consider any harm that the experimental drug causes when used under the Right To Try auspices, and thus eliminate the safeguards and monitoring that otherwise are done to determine whether the patient has been helped or harmed by the experimental drug.

We strongly support the need for terminally ill patients to receive the best medical treatments as quickly as possible.  Unfortunately, the right to try approach of this legislation would have the following dangerous outcomes:

➢     Hinder patients from obtaining the experimental drugs that are more likely to help them.

➢     Enable companies to charge extremely high prices for experimental drugs, instead of providing them for free in clinical trials.

➢     Reduce or eliminate the incentive of pharmaceutical companies to perform scientific studies to prove that their experimental medications are safe and effective, and for whom.  Why would drug companies agree to spend time and money researching their product when they can instead spend that money on marketing to desperate patients?

➢     The resulting lack of patients participating in clinical trials for these experimental drugs could make it difficult, if not impossible to determine if the medication will make the patient feel better or live longer, and what dosage the patient should take.

➢     Make it nearly impossible to prove if the risk outweigh the benefits for these drugs dispensed without any oversight.

new study published last week in BioMed Central found that 76% of the drugs provided through FDA’s current compassionate use program eventually received FDA approval.  This indicates that while 3 out of 4 experimental drugs being made available through the current program have benefits that outweigh their risks for many (though not all) patients, one out of every four is not.  Since the loosening of safeguards in the proposed Right to Try law would lower those odds, probably substantially, study authors bioethicist Dr. Arthur Caplan and his colleagues concluded, “allow the FDA to retain its oversight and approval role for these programs, in order to help mitigate safety risks for patients.”

There is no scientific evidence that Right To Try programs already operating in a number of states are helping patients survive longer or have a better quality of life.  Nobody has studied how many patients were harmed by these programs, and the proposed legislation would not allow such studies either.  Desperate patients will be vulnerable to false or misleading promises.  Drug companies which now agree to supply free experimental drugs under FDA’s Expanded Access Program may refuse to do so when there is no oversight.

The proposed law would potentially harm many patients and family members, including seriously ill patients who could be harmed by scam artists or unconventional medical practitioners who will take advantage of them. This legislation could open the floodgates to undermine the scientific and carefully-monitored medical requirements that made FDA approval the gold standard for the world.  Please oppose this amendment or any other efforts to have this legislation become law.

Sincerely,

National Center for Health Research
Breast Cancer Action
Breast Cancer Consortium
Jacobs Institute of Women’s Health
MedShadow
MRSA Survivors’ Network
National Consumers League (NCL)
National Organization for Women (NOW)
National Physicians Alliance (NPA)
National Women’s Health Network (NWHN)
Our Bodies Ourselves
Treatment Action Group (TAG)
Washington Advocates for Patient Safety (WAPS)
Woodymatters
For more information, please contact Jack Mitchell at jm@center4research.org.

Letter of Opposition to Trickett Wendler Right to Try Act of 2017 (S. 204)

clip_image002February 24, 2017
United States Senate
Washington, DC 20510

Dear Senator:

As members of the Patient, Consumer, and Public Health Coalition, we are writing to thank you for not co-sponsoring the Trickett Wendler Right to Try Act of 2017 (S. 204), introduced by Sen. Ron Johnson (R-WI).  We urge you to strongly oppose this measure.

This bill purports to help dying patients gain access to experimental treatments that can save their lives.  However, patients already have this access through the FDA’s Expanded Access Program, which gives patients access to experimental drugs if their doctor believes it is appropriate and the company making the drug agrees to provide it for that use.  The bill instead does something much more dangerous: It would remove the FDA’s role in protecting many millions of patients from unsafe or ineffective treatment options – patients who already have safe and effective treatment options.

While we all greatly sympathize with the need for terminally ill patients to receive the best medical treatments as quickly as possible, the right-to-try approach of this legislation would:

➢    Hinder patients’ ability to obtain the experimental drugs that are more likely to help them.

➢    Enable companies to charge for experimental drugs, instead of providing them for free in clinical trials.

➢    Reduce or eliminate the incentive of pharmaceutical companies to do scientific studies to prove that their medications are safe or effective, and for whom.  Why would companies agree to spend time and money researching their product when the company can spend that money on marketing it instead?

➢    Due to the lack of incentive to conduct clinical trials, could make it impossible to scientifically prove if a medication will make the patient feel better or live longer, and what dosage the patient should take.

➢    For the same reason as above, could make it impossible to scientifically prove if the side effects are so debilitating or dangerous that they outweigh the risks for most patients.

This scenario would take us back to the early twentieth century, when “snake oil salesman” peddled untested home remedies and “cures” to patients who had no access to information about whether the product would help or harm them.  Indeed, tragedies arising from those “right to try” laissez faire and harmful medical policies were the very reason that the FDA was created.

While this Senate and House legislation calls for access to experimental drugs which have completed Phase 1 clinical trials, and remain under investigation in a clinical trial approved by FDA, Phase 1 trials are conducted with only small groups of healthy volunteers or patients to determine safe dosage range and identify relatively frequent, short-term side effects.  These very preliminary trials are only the beginning of safety testing, and do not test for effectiveness.

As noted above, the FDA already has a program in place to expedite access to experimental and unapproved drugs for which there is some evidence of safety and efficacy and some knowledge about the appropriate dosage.  The FDA Expanded Access Program routinely utilizes what the agency terms “compassionate use” for patients when doctors request such access.  As would also be the case under all Right-to-Try laws, access to the treatment is determined by the company; if the company doesn’t want to provide the experimental treatment to the individual patient, it does not have to do so.  Under current law, when the company agrees to provide the drug to the patient, the FDA quickly agrees to allow the patient access more than 95% of the time.  Moreover, in urgent circumstances, the FDA had made such a decision within 1 or 2 days.

Currently, the most difficult part of the process is for doctors to obtain permission from the company.  The FDA is working to facilitate access by ensuring that companies make it easier for doctors and patients to quickly identify the contact person or persons at each company who is in charge of the Expanded Access Program.  The drug companies are also asked to make their policies regarding access to specific experimental drugs easily available to the public.

It is important to note that insurance companies generally do not pay for experimental treatments.  This is not a problem in clinical trials or under the FDA’s Expanded Access Program, because in those cases, treatment is almost always free.  However, there is reason to be concerned that pharmaceutical officials will be unwilling to make experimental treatments available for free if they are more frequently requested under the proposed Right to Try Act.

No Evidence that Lives Will Be Saved

In addition to other problems with the legislation, it does not clearly define “terminally ill” patient, or who makes that determination.  How many patients with cancer or heart disease would be considered terminally ill, since those serious illnesses can cause death?  It is not always possible to predict how long a seriously ill person will live, and patients could be easily manipulated by scam artists and others who are motivated by financial gain to convince patients to “try” the “latest” experimental treatment.  Such problems have long been documented regarding unproven treatments sold at outrageously high prices in Mexico, where patients have been irreparably harmed by such treatments.

Bioethics experts and many physicians also point to the following problems with the law:

✓    Desperate patients will be vulnerable to false or misleading promises about likely benefits and failed to be warned about the risks, which may include dying earlier and more painfully than they would without the experimental treatment.

✓    Despite patients’ hopes, there is no evidence that access to experimental treatments through humanitarian exemptions helps more patients than it harms.

✓    There is no evidence that various state right–to-try laws have saved lives or improved patient outcomes.

✓    A survey conducted by Modern Healthcare in late 2015 found no evidence of patients receiving an experimental therapy as a result of state right-to-try laws, despite the fact that more than 20 states already had such laws in place.

✓    If a federal Right to Try Act were to become law, even small companies that make prescription drugs would need to develop complex policies to make such treatments available.

We urge you to strongly oppose S. 204 because it would undermine the successful program already in place to enable patients to have access to experimental drugs for free or at cost.  The proposed law would potentially harm many patients and family members, including seriously ill patients who could be harmed by scam artists in a treatment environment with no checks and balances. This legislation could open the floodgates to undermine the scientific requirements that made FDA approval the gold standard for the world.

Sincerely,

National Center for Health Research
American Medical Women’s Association (AMWA)
Association for Medical Ethics (AME)
Breast Cancer Action (BCA)
Breast Cancer Consortium
Breast Implant Victim Advocacy
Center for Medical Consumers
DES Action
Jacob’s Institute of Women’s Health
MedShadow
MISSD
Mothers Against Medical Error (MAME)
MRSA Survivors Network
National Consumers League (NCL)
National Physicians Alliance (NPA)
National Women’s Health Network (NWHN)
Our Bodies Ourselves
Quinolone Vigilance Foundation
TMJ Association
Washington Advocates for Patient Safety
WoodyMatters
For more information, please contact Jack Mitchell at jm@center4research.org.

Coalition comments to the FDA on voluntary sodium reduction goals

October 17, 2016

 

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

 

 

Comments of members of the Patient, Consumer, and Public Health Coalition on Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations or Sodium in Commercially Processed, Packaged, and Prepared Foods

[Docket No. FDA-2014-D-0055]

 

 

As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Food and Drug Administration’s voluntary sodium reduction goals.  We agree that high sodium consumption “is a contributory factor in the development of hypertension, which is a leading cause of heart disease and stroke.”[1]

 

We support FDA’s approach to lowering sodium content by avoiding “large, abrupt changes to individual products that might result in noticeably altered taste, greatly reduced shelf life, or other undesirable product outcomes.”[2]

 

We also support FDA’s “plan to monitor the levels of other nutrients (e.g., added sugars and saturated fat) … to ensure that no broad trends emerge that negatively affect the nutritional quality of the foods.” [3] This has happened in the past when processed food manufacturers lowered the fat content of products such as cereals, yogurts, and snacks but then spiked the sugar levels to improve taste.[4]

 

The overall goal of this guidance is to reduce sodium intake in the general population to 2,300 mg/day from the current average adult level of 3,400 mg/day.[5] More than three-quarters of sodium that Americans consume is added when the food is manufactured or commercially prepared. By encouraging manufactures, retailers and food service to reduce sodium, consumers have more access to healthier choices.

 

Research provides important information that should be used to help determine how best to reduce salt intake. A recent study by the U.S. Department of Agriculture found wide variation in the amount of sodium in similar types of products, which suggests that current food manufacturing practices and food preferences vary enough that sodium levels could be reduced in some types of foods relatively easily, and without reducing consumers’ enthusiasm for those products.[6] Others have examined the amount of sodium in the same or similar items from the same fast food restaurants in different countries or in the US over time. Again there were wide variations in the amount of sodium, suggesting that gradual changes in salt levels would not have a negative impact on consumer preferences.[7] [8]

 

We support the FDA’s approach of using mg/ 100g as a standard way to monitor changes in the sodium in various foods independent of changes in serving size or other nutrient levels. However, it would be helpful for consumers and health professionals to also see what these changes mean in units that are found in the marketplace. This would increase transparency and allow outside monitoring.

 

We also want to encourage caution with the development of new or expanded use of food additives and other substances for food preservation or salty flavor. Any such chemicals or substances should be sufficiently studied to ensure that they do not have a negative impact on health in the short-term or long-term.

 

By making healthier options more available, consumers are able to choose foods based on what is important to them. We believe that many consumers will choose healthier options when they become available and as lower sodium levels become the norm. Current initiatives by individual companies, New York City, and the United Kingdom have shown that large reductions in sodium content are attainable and attractive to consumers.

 

We reject the claim that some target levels for sodium might be low enough to be unhealthy. “More than 75 percent of the sodium in the average American Diet comes from salt added to processed foods,” according to the American Heart Association.[9] Consumers can continue to add salt to their food, if they choose to do so, since  able salt is plentiful and inexpensive in the United States. Currently, it is difficult for individuals to lower the sodium in their diet because the salt is added before the consumer purchases it. Reducing the sodium in processed and restaurant foods gives individuals greater control over the amount of sodium that they consume.

 

In summary, we strongly support the FDA’s effort to reduce sodium levels in foods, while monitoring foods to ensure that sodium reductions are not offset by unhealthy changes in nutrients such as increased saturated fat or sugar. The FDA must also ensure that methods to compensate for the reduction do not include substances that could harm consumers. Reducing sodium levels in processed and prepared food would provide consumers with more control over the amount of sodium they consume and thus make it easier for individuals to choose a lower sodium diet and lower the risk for hypertension, heart disease, and stroke.

American Medical Student Association

American Medical Women’s Association

Jacobs Institute of Women’s Health

MRSA Survivors Network

National Center for Health Research

National Physicians Alliance

Washington Advocates for Patient Safety

WomenHeart: The National Coalition for Women with Heart Disease

WoodyMatters

 

[1] FDA DG (June 2016).

[2] Food and Drug Administration (June 2016). Draft guidance, Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations or Sodium in Commercially Processed, Packaged, and Prepared Foods [Docket NO. FDA-2014-D-0055].

[3] FDA DG (June 2016).

[4] Nguyen PK et al  (2016) A systematic comparison of sugar content in low-fat vs regular versions of food. Nutrition & Diabetes 6:e193.

[5] FDA DG (June 2016).

[6] Ahuja, JKC et al (2015) Sodium content of popular commercially processed and restaurant foods in the United States. Preventive Medicine Reports 2:962-967.

[7] Dunford E et al (2012) The variability of reported salt levels in fast foods across six countries: opportunities for salt reduction. CMAJ 184(9):1023-1028.

[8] Rudelt A et al (2012) Fourteen-year trends in sodium content of menu offerings at eight leading fast food restaurants in the USA. Public Health Nutrition 17(8):1682-1688.

[9] American Heart Association (December 8, 2015). Processed Foods: Where is all that salt coming from?

Coalition Letter Protesting 21st Century Cures

November 29, 2016

The Honorable ________
United States House of Representatives
Washington, DC 20515

Dear Senator/Congressman ____:

The undersigned nonprofit organizations represent members of the Patient, Consumer and Public Health Coalition, which includes more than 6 million healthcare providers, public health experts, and consumer and patient advocates.  We are writing to urgently express our strong opposition to the newly revised 21st Century Cures Act, both in terms of the process of trying to pass a bill without adequate time for public debate, and for specific provisions in the bill that would harm patient safety.  Passing a complicated health bill in the rush of a lame-duck session is always problematic.  Passing a 996-page bill that was negotiated behind closed doors and includes provisions that were never voted on before represents the kind of legislative sausage that Congress should reject.

While the bill includes some positive measures, the most important ones – funding for the National Institutes of Health (NIH) and the Opioid bill that previously passed – are not guaranteed in this legislation.  Unlike the earlier version of the 21st Century Cures Act that was passed in 2015, the funding is not mandated in the new version.  In exchange for the hope of additional funding, the bill contains dangerous measures that would lower safety and approval standards for drugs and medical devices at the Food and Drug Administration (FDA).  This would put all patients and consumers at risk.

For example, the bill would allow antibiotics to be approved based on minimal evidence of safety and effectiveness through a “limited population” approval pathway.  The bill would not require that the antibiotics be studied on the target population that the new drugs would be approved for.  In other words, it is possible that the antibiotics would not meet the urgent need that they are intended for.  Unfortunately, these antibiotics could then be widely advertised and used by patients who are not likely to benefit, and could be seriously harmed by them.  In the long run, that would contribute to antibiotic resistance.  While the Senate version had several restrictions designed to help protect patients, the 21st Century Cures version released this past weekend does not.

The MEDTECH section of the bill would deregulate electronic medical records and decision support software.  A study by the National Center of Health Research (NCHR) found that these types of health IT devices can cause life-threatening problems when they miscalculate incorrect drug dosages for chemotherapy drugs and other treatments.  The Breakthrough Devices (Sec. 3051) encourages shorter and smaller clinical trials for medical devices. These smaller studies make it impossible to include sufficient numbers of women, men, seniors, and racial and ethnic minorities.  Moreover, a recent study of high-risk medical devices found that the median number of participants is currently only 65 patients, which is already too small a cohort to adequately evaluate safety and effectiveness for both men and women, let alone for elderly men and women compared to young adults, or for minority populations.

The bill would also drastically lower standards by allowing companies to provide FDA with summaries of their data, instead of the data itself, as now required, when they want to sell drugs for new indications (treatments).  It also encourages the FDA to make approval decisions based on “real world evidence” that is not necessarily scientifically sound.  The FDA currently reviews and scrutinizes scientific data provided by companies, which is necessary to make sure the benefits outweigh the risks for any approved indication.  Providing summaries would also reduce information about the possible risks to particular demographic groups, such as women or patients over 65.

The Accelerated Approval for Regenerative Advanced Therapies (Sec. 3033), creates an expedited review pathway for ‘regenerative medicine.’  This section has been promoted by extensive campaign contributions, was not in any previous version of the Cures legislation, and should not be rushed through without adequate discussion and debate.

The bill also allows off-label promotion of medical products under certain circumstances, which reduces the incentive for companies to conduct scientific research to prove that their products are safe and effective for new indications.

By lowering standards for approval of drugs and devices, and in some cases eliminating them, the bill would increase the cost of healthcare and pharmaceuticals at a time when such costs have become a grave threat to affordability of health insurance and to the survival of Medicare.  The implications for patients’ health and the affordability of medical care can’t be overstated.  Researchers at the best medical schools in the country already have shown that many ineffective and unsafe drugs have already been approved by FDA on the basis of the kind of preliminary data encouraged by 21st Century Cures.

This situation would worsen under the bill.  For example, the National Center for Health Research assessed the cost of new, ineffective cancer drugs and found that they cost the same or more as cancer drugs that are proven to work.  In addition, the bill would continue the existing pediatric priority review voucher program, even though a recent GAO review of the program concluded that the program has questionable benefit.  This increases the cost of medications and undermines FDA’s ability to set its work priorities based on public health needs.

The extensive and expensive lobbying efforts in favor of 21st Century Cures have been designed to make every aspect of the bill seem bipartisan and non-controversial.  If that were true, however, the bill would not have been negotiated behind closed doors and released during the Thanksgiving holiday weekend.  That is why dozens of patient, consumer, physician, labor, and public interest groups, as well as former Members of Congress, have asked the Congress to delay consideration of the bill.

Thank you for your consideration of our views on this legislation.  We must ensure that patients can trust their drugs and medical devices to improve their health rather than harm it.

Sincerely,

National Center for Health Research
American Medical Student Association
American Medical Women’s Association
Annie Appleseed
Association for Medical Ethics (AME)
Advocating Safety in Healthcare E-Sisters (ASHES)
Breast Cancer Action
Center for Medical Consumers
Connecticut Center for Patient Safety
ISMP
Jacobs Institute
Mothers Against Medical Errors
MISSD
MRSA Survivors Network
National Physicians Alliance
National Women’s Health Network
Our Bodies, Ourselves
Quinolone Vigilance Foundation
TMJ Association
Treatment Action Group
Union of Concerned Scientists
Washington Advocates for Patient Safety (WAPS)
WomenHeart: The National Coalition for Women with Heart Disease
WoodyMatters

 

For more information, please contact Jack Mitchell at jm@center4research.org.