Category Archives: Testimony & Briefings

Our Written Testimony in Support of HB 457 for the Maryland House of Delegates Environment and Transportation Committee

Bill Title: Environment – Synthetic Turf- Chain of Custody

February 16, 2024

I am writing in enthusiastic support of HB457 on behalf of the National Center for Health Research (NCHR), as the president of the Center and as a long-time resident of Maryland’s District 16. The bill would establish a simple chain of custody for synthetic turf. NCHR is a nonprofit think tank the conducts, scrutinizes, and explains research with important public health implications for adults and children. We are nationally respected as a source of unbiased information and do not accept funding from entities with a financial interest in our work.

This is an important bill to the public health of Maryland residents because it would require transparency regarding synthetic turf and turf infill.  By enabling the public to be informed about the chain of custody from the time of installation; use; possible reuse; recycling; and disposal, the bill would ensure that individuals, policy makers, and communities could make informed decisions that are essential to the health of adults and children in Maryland.  The National Center for Health Research is not an environmental organization, but we are very knowledgeable about the scientific issues pertaining to synthetic turf and infill and how inappropriate disposal of those products can affect the health of Maryland residents.

We urge the immediate passage of this bill, because the lack of transparency regarding the chain of custody of synthetic turf and infill has made it impossible for families, communities, and government officials to make informed decisions that affect the health of adults and children.  I speak from experience on this matter: synthetic turf became popular locally while my children were playing soccer while growing up in Maryland, and like most parents I was unaware of the environmental or health issues involved.  As I became knowledgeable, I was shocked by the widespread misinformation regarding the disposal of these materials.

As the legislators representing our families, you can improve transparency and help communities, families, and government officials determine how synthetic turf and infill are being used and what happens to those products when they are removed.  We strongly urge your favorable report on HB457.

Respectfully submitted,

Dr. Diana Zuckerman
President

Testimony of Diana Zuckerman at FDA Advisory Panel on Blood Irradiators

November 7, 2023


I’m Dr. Diana Zuckerman, president of the National Center for Health Research. We scrutinize the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products. So I have no conflicts of interest.

In addition to my current work, my perspective reflects my post-doctoral training in epidemiology and public health, my training in bioethics, previous policy positions at HHS and a Congressional Committee with oversight over FDA, and as a faculty member and researcher at Yale and Harvard. I am also a founding board member of the Alliance for a Stronger FDA, which is a coalition of industry and nonprofit organizations that work to ensure that the FDA has sufficient appropriations to fulfill its important mission.

Thanks for the opportunity to speak today. Since you have such impressive medical expertise on this panel, I will focus on policy issues that have important implications for patients – a goal that we all share.

The FDA has spelled out their concerns about these devices in their written summary and will talk about them today, so I will focus on the big picture.

  1. These devices have been treated as 510k devices since 1976 and that has resulted in limited scientific data — in fact, FDA found very few studies of either safety or effectiveness, none of which were randomized controlled trials and none that evaluated a specific device used to prevent cancer metastasis.
  2. Most importantly, no studies indicate that the use of blood irradiators improves patient outcomes.

So given the lack of evidence of benefits, what are the risks?

  • There are few adverse event (AE) reports to FDA’s Medical Device Reporting (MDR) system. But that may be because the devices aren’t used frequently and MDR reports are voluntary and everyone agrees that AEs are under-reported. We all know that surgeons are very busy and do not have strong incentives to report AEs, especially when it isn’t clear if a problem was caused by the device vs. human error.
  • Even so, the FDA has identified numerous potential serious risks, including incorrect or improper dose of radiation, damage to blood components caused by the radiation, and radiation causing an immune response that is harmful to cancer patients. Device malfunction or poor design could result in unintended radiation exposure of the operator or the public, or electrical shock or burn.
  • Several papers reported that blood irradiation took additional time, 15-20 minutes, and that can sometimes be harmful.
  • Perhaps most important, most patients and surgeons assume that these products are proven safe and effective. Would they choose to use them if they knew how little scientific evidence there is regarding safety or effectiveness?

THE BOTTOM LINE: These devices fit FDA’s definition of Class III

  1. “Insufficient information exists to determine that general and special controls are sufficient to provide reasonable assurance of its safety and effectiveness.”
  2. “The device is for a use which is of substantial importance in preventing impairment of human health.”

The FDA is asking if special controls would be sufficient instead of a PMA.  They don’t specify which special controls, but the problem here is we don’t know if the products have any benefits regardless of how they are used.

Would FDA impose special controls requiring evidence of effectiveness, and if so, why not require a PMA instead? We don’t know if either of the current products are safe and effective, and we don’t know if one is better than the other. That is why I encourage you to urge the FDA to categorize these as Class III and require a PMA, so that we will finally have well designed clinical trials to determine safety and effectiveness.

Would registries be as good as clinical trials to study blood irradiators that are already on the market? Registries can collect important information.  But registries do not provide a control group, and this is especially problematic for a device that is not widely used, since those who use blood irradiation to prevent metastasis may differ in important ways from those who do not.

Testimony of Dr. Diana Zuckerman About I-omburtamab FDA Advisory Committee Meeting

October 28, 2022


I’m Dr. Diana Zuckerman, president of the National Center for Health Research. We scrutinize the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products.  

My expertise is based on post-doc training in epidemiology and public health, my previous policy positions at Congressional Committees with oversight over FDA, my previous position at the US Department of Health and Human Services, and as a faculty member and researcher at Harvard and Yale. 

This is a terrible disease and the personal stories are very important.  What is the evidence that this treatment actually works?

The sponsor has provided data from 2 studies:

  1. A single center, single arm trial (Study 03-133) included 94 pediatric patients ages 0.9 to 13 years with CNS/LM relapsed neuroblastoma who received intracerebroventricular infusions.  Three doses were used: 25 mCi, 33.5 mCi, or 50 mCi, based on age. The Primary Endpoint was overall survival and the results showed 45% alive at 3 year.
  2. The second study is not completed yet.  The Interim report of this multi-center single arm study (Study 101) shows 20 patients with imaging evidence of CNS/LM disease.  The Sponsor reports 7 responders, but 3 of these are not confirmed.  That matters because transient responses are not necessarily meaningful, and therefore can’t be considered evidence.  The Primary Endpoint is 3-year overall survival, but those data are not yet available.

Safety

It is important to note that 19% of patients permanently discontinued using the drug due to an adverse reaction in Study 03-133 and 28% of patients in Study 101.  Most were due to myelosuppression.  However, 3% were due to chemical meningitis (3 cases in 03-133 and 1 case in Study 101), and there was one case of fatal intracranial hemorrhage

Shortcomings of the Studies

Only one study was completed and it wasn’t randomized or blinded or controlled.  The external control group was very small and they differed from the patients receiving the treatment, because the latter had more intensive prior treatment.  There were significant population differences as well as treatment differences between the treatment group and the external controls.  In addition, overall survival for this condition has improved since the control data sample was collected.

Therefore, we agree with FDA’s conclusion that differences in overall survival can’t be “reliably attributed” to the drug.  We also agree that “the application does not include reliable response rate data to provide supportive evidence.”

In Study 101, no patient demonstrated a response that can be unequivocally   attributed to the drug.  And there was no overall response rate calculated for Study 03-133  and only very limited overall response rate data in Study 101.

FDA has been the Gold Standard?  Do these data meet that standard?

The FDA Summary states: The comparator is too dissimilar to the treatment group.  There is no reliable information on tumor response rate.  Therefore, the submitted study cannot be considered an adequate and well-controlled trial necessary to establish effectiveness. That’s the standard that the law requires for FDA approval.

On the other hand, there is an unmet need. These children need treatment.  Should FDA be flexible even though the data are clearly inadequate?  Why isn’t this an accelerated approval application instead of a regular application? Are the data even good enough for accelerated approval?

Are FDA Decisions Perpetuating Poor Studies?

Why didn’t the sponsor conduct a randomized, double blind controlled trial?  This isn’t a rhetorical question.  What’s the incentive for any company to conduct a well-designed study if a poorly conducted study with questionable findings results in approval?  Those controversial decisions set a dangerous precedent.

Unfortunately, when FDA approves a drug based on inadequate data, all companies lose the incentive to conduct well-designed studies.  Not just the company whose product is approved, but all other companies as well.

Patients Deserve Better

We do patients and their families no favors by approving treatments that aren’t proven to work. 

FDA’s Expanded access program is the way to give patients access to experimental drugs, because it provides free treatments in a well monitored situation where the patients and families know that they are taking a risk using an experimental drug.  Why should patients pay to take an experimental drug, thinking it is proven safe because it is FDA approved?

I can’t believe I have to say this: Without an appropriate control group, it is not possible to provide evidence that patients and doctors need to make informed decisions.  Even a small study with a small well matched control group is better than nothing.

Unfortunately, the preponderance of evidence doesn’t support approval for this drug.

The Advisory Committee agreed with our assessment and voted 16-0 that the studies did not prove the drug improved overall survival. The FDA subsequently rejected the application.

NCHR Testimony at FDA Advisory Panel on Wound Dressings

October 26, 2022


I’m Dr. Diana Zuckerman, president of the National Center for Health Research. We scrutinize the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products. So I have no conflicts of interest. 

My expertise is based on post-doctoral training in epidemiology and public health, my previous policy positions at Congressional Committees with oversight over FDA, my previous position at the U.S. Department of Health and Human Services, and as a faculty member and researcher at Harvard and Yale. 

There are unique issues for the different types of wound dressings you are considering today, but they have some issues in common:

  1. They have been treated as 510k devices despite not being categorized as Class II or any other Class
  2. They have been used for years but FDA found very few studies pertaining to safety or effectiveness, and some were specific to particular types of surgery, such as diabetic foot ulcer care.  
  3. The information from FDA’s AEs reporting on the MDR system is  limited but the FDA has identified several potentially serious AEs, including toxicity, infections, and delays in wound healing.  These are important because they clearly can interfere with the success of surgery. 
  4. Most patients and surgeons assume that these products are proven safe and effective.  They would be surprised to know how little scientific evidence there is regarding safety and effectiveness.

You heard testimony from Madris Kinard from Device Events this morning, and saw her excellent analyses of adverse events based on information from the FDA database.  At our request, she also provided an analysis of wound dressings to our research center, based on the FDA total product life cycle database.  The results indicated thousands of reports of contamination and problems with non-sterile packaging of wound devices on the FDA.  Most were from the last 4 years. For the animal derived wound dressings, which are collagen dressings, there are 126 MDRs and 12 recalls.

FDA and other experts agree that MDRs are under-reported. It is a voluntary system, and as panel members mentioned this morning, it is difficult to distinguish between adverse events caused by the device vs. the procedure.  We all know that surgeons are very busy and do not strong incentives to report adverse events if the causes are unclear.  Keep in mind, for example, if a patient’s wound becomes infected, surgeons would not necessarily report it as an MDR for the wound dressing.

The FDA has delineated some very clear special controls for these devices if they are considered Class II and continue to be cleared through the 510k process.  These are good efforts that would improve upon the current regulatory policies for these devices.

But the special controls have 2 major shortcomings:

#1: They don’t include inspections, which could reduce harm caused by contamination and non-sterile packaging.

#2:  None of those controls will provide scientific data on the safety and effectiveness of any of these wound dressing products.   And that is the one crucial type of information that is missing. Insufficient information is currently available, especially regarding which specific products are safest and most effective for which indications.  The issue isn’t just different types of wound dressings, but the products made by different companies.  It is likely that some are better than others.  That is why I encourage you to urge the FDA to categorize wound dressings as Class III, so that we will finally have well designed clinical trials to determine safety and effectiveness. 

What about registries?  Registries can collect important information.  But as you consider all the medical devices being discussed today and tomorrow,  please remember that registries are controlled by medical societies and as such the data from them are not available to the public or the FDA, except for the information that those medical societies choose to make public.  So unfortunately, we can’t rely on registries to provide objective, comprehensive information about safety or effectiveness to the FDA or the public.

Testimony of Diana Zuckerman at the Meeting of EPA’s National Environmental Justice Advisory Council on September 28, 2022

I’m Dr. Diana Zuckerman, president of the National Center for Health Research. We scrutinize the safety and effectiveness of medical and consumer products, and we don’t accept funding from companies that make those products.  Our largest program is focused on cancer prevention and treatment.  My expertise is based on post-doc training in epidemiology and public health, and my previous positions at HHS and as a faculty member and researcher at Harvard and Yale.

 Thank you all for the important work you’ve been doing and will be doing on this Advisory Council.  As a public health person, I’ve always been surprised at the lack of other public health advocates who are active on environmental issues and environmental justice issues, and I want to offer to be helpful in any way that would be useful to all of you.  We all know that lives are at stake.

I want to comment very briefly on the PFAS recommendations, since that’s an issue we’ve worked on for years.  Let me add that we are very concerned about all endocrine disrupting chemicals not just PFAS.

Everything I heard about PFAS this afternoon was inspiring and important.  I would just suggest that it’s a huge task, and I encourage you to start a little smaller in order to succeed in educating the public and especially environmental justice communities and at the same time focus on actions that are doable, that will inspire others, and that will make change happen.

Testimony of Dr. Diana Zuckerman About COPIKTRA FDA Advisory Committee Meeting on September 23, 2022

I’m Dr. Diana Zuckerman, president of the National Center for Health Research. We scrutinize the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products. Our largest program is focused on cancer. My expertise is based on post-doc training in epidemiology and public health, and my previous positions at HHS and as a faculty member and researcher at Harvard and Yale.

In April this same Committee examined 6 randomized trials of Pi3K inhibitors used for hematologic malignancies and found that all reduced overall survival –despite potential benefit for PFS. FDA says that these consistent findings across multiple randomized trials within the same drug class is unprecedented in oncology.
That’s a shocking finding that we need to take seriously. And that’s the context for today’s meeting.

The sponsor did a 5-year randomized controlled post-market study – 3 years longer than the data that resulted in initial approval. They found the median OS was 11 months shorter than the comparison drug. In fact, 50% of the patients died during those 5 years, compared to 44% taking the other treatment – a treatment that is no longer considered effective and so is rarely used.

Then they analyzed patients with 2 or more prior therapies, since that was the indication. Those Copiktra patients lived about 3 months shorter – not as bad as the larger sample, but still worrisome. Especially since 56% died during the 5 years of the study, compared to 49% assigned to the other treatment.

Adverse events caused the deaths of 15% of the Copiktra patients compared to only 3% of the other treatment group. And the percentage of Grade 3 or greater AEs was 91%, and 78% had Serious AEs–about twice as high as the comparison group. This has clear implications for quality of life, in addition to the patients not living as long.

The FDA did the right thing by requesting this post-market study. And the sponsor did the right thing by completing the study. Now is the time to listen to the results. We urge this Advisory Committee and the FDA to make it clear that approvals will be rescinded when evidence indicates that promising short-term results are reversed based on longer term data from post-market studies.

Patients and oncologists want as many treatment options as possible, but we do patients no favors by maintaining approval for a drug that does more harm than good. As was true yesterday for other cancer treatments, the preponderance of evidence is clear today.

As a cancer survivor myself, I understand the need for treatment options. I thank this committee and the FDA for its objective, scientific analysis of the data presented yesterday and today. I hope it will help everyone understand that an individual patient may seem to do well on a specific treatment, but that treatment may not be the REASON the patient did well. There are other individual differences that cause some patients to do better than others, and to live longer than others. As FDA stated, these diseases are often indolent. That’s why large, long-term randomized controlled trials are so important – to help us understand which treatments are better for which patients.

There are so many problems with the data, including the very substantial changes in treatment standards that have occurred since this study was designed, the low number of US patients, and the dearth of nonwhite patients – all these support rescinding approval for this indication.

It takes years for FDA to rescind approval unless the sponsor does the right thing by voluntarily doing so. But your vote today will be very influential.

I hope that the sponsor will conduct new research to determine if a subgroup of patients can benefit from this drug under current treatment standards, and if a lower dose is safer as well as effective, and if so FDA should of course consider approval for a different indication. But that isn’t where we are today.

Testimony of Dr. Diana Zuckerman About PEPAXTO FDA Advisory Committee Meeting on September 22, 2022

I’m Dr. Diana Zuckerman, president of the National Center for Health Research. We scrutinize the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products.  Our largest program is focused on cancer.  My expertise is based on post-doc training in epidemiology and public health, and previous positions at HHS and faculty member and researcher at Yale and Harvard.

All of us want more treatment options for refractory cancers, but we want patients to be able to have confidence that FDA approval means a product is proven safe and effective.  The OCEAN study of 495 multiple myeloma patients has important information that was not available when the drug received accelerated approval. Even if some patients taking Pepaxto do well, it is only with a randomized controlled trial that we can determine if Pepaxto is helpful or if the patients would do better without it.

Our Center’s analyses support the FDA findings that the data do not confirm the indication.  In the randomized trial comparing Pepaxto to another treatment option, median survival was 5.3 months shorter, and the death rate was slightly higher.

The Sponsor says some patients do better but we agree with FDA that “Results from subgroup analyses cannot be used to conclude benefit in a subset of patients, when the overall patient population has shown a detrimental treatment effect.”

We also agree with the FDA that PFS is not improved and that “An anti-cancer therapy that prolongs PFS is not considered safe and effective if the therapy results in a detrimental effect on OS”

Public trust in the FDA has been weakened in recent years.  FDA standards matter to all of us.  Would you want your loved one to take Pepaxto rather than a superior treatment option?  Not all oncologists will be as knowledgeable about the data as those serving on this panel.

It concerns us that the sponsor continues to ignore FDA concerns, rely on shortcuts instead of better research, and that the company withdrew the drug in October but then rescinded the withdrawal.  Was this just a delaying tactic?  We agree with the FDA that the sponsor did not provide new data, and with Dr. Pazdur that FDA approval relies on solid information about appropriate dosage, which is lacking here.

Maybe Pepaxto would benefit some types of patients and better research is needed to prove that.  As FDA states, the preponderance of evidence from the prespecified analysis and in all other subgroups suggests an increased risk of death in patients and a potential for harm.”

We were pleased that the Committee voted 14-2 that the evidence does not support that the benefits outweigh the risks.

The FDA followed through and rescinded Pepaxto approval in December, 2022.

Diana Zuckerman Statement on the Role of FDA in Health Inequities Meeting of the National Academy of Medicine

July 26, 2022

Thank you for the opportunity to speak today on how current FDA policies contribute to health inequities.

The National Center for Health Research is a nonprofit think tank founded in 1999 that conducts research and scrutinizes research conducted by others to evaluate medical products, procedures, and policies. We do not accept funding from companies whose products we evaluate.

There are many reasons for health inequities in the U.S., but today I will focus on one that usually gets no attention: Federal laws regarding diversity in clinical trials.

The U.S. Department of Health and Human Services requires research studies to include people representing diverse racial and ethnic backgrounds. This is not always enforced, but the requirement is in the law and NIH, CDC, SAMHSA and other agencies make an effort to abide by this law.

The one exception among federal public health agencies is the FDA, which encourages but does not require diversity in clinical trials. They justify this because the agency doesn’t pay for the studies – the companies that make the products pay for the studies. However, taxpayers do pay for FDA staff that regulate these products, and taxpayers also pay for the products themselves.

Our NCHR Study of Racial Diversity

To see the impact of the lack of a requirement for FDA, we examined 22 of the highest risk medical devices reviewed by the FDA Advisory Panels for 4 recent years. We found:

  • The number of nonwhite patients in key trials ranged from 4 (3%) to 6,788 (17%).
  • Of 19 treatment devices, only 7 had analyses for racial groups for effectiveness and only 3 for safety.
  • 69% to 99% of the patients in the studies were White. The number of nonwhites was as low as 4; 1 for Hispanics.
  • There were too few patients in most racial or ethnic groups to draw meaningful conclusions.
  • Even when subgroup analyses were conducted, their conclusions were often discredited by the FDA, blamed on chance differences due to small sample size. If there was a lack of diversity or even when racial or ethnic differences were significant, that information was were often not included on the label, which is the main source of information for physicians and patients.

    Recent Examples from the FDA

    When the FDA reviewed the data on Aduhelm for Alzheimer’s Disease, they focused on 2 studies comparing placebo to high and low dosage:

    Study 301: 8 Black patients (half of 1%) and 37 Hispanic patients (2%)
    Study 302: 11 Black patients (less than 1%) and 67 Hispanic patients (4%)

    When the FDA reviewed data on the Reducer circulatory system device for angina, they found that there were no Black or Hispanic patients, and more than 80% of the patients were White or male, or both. And yet, most patients with angina are not White males.

    Why is Diversity Important in Clinical Trials?

    Response to treatment can vary due to genetics, health habits, metabolism, body part size/shape and other factors. If you exclude certain groups, you don’t know what works best for them. Keep in mind that you need enough patients to study safety and effectiveness for patients in each group.

    Example – Lutonix drug-coated balloon catheter to open blocked arteries

    You can see on this graph that the device seemed effective compared to the control group when men and women were combined. However, you can also see that the device was only effective for men, not for women. In fact, women did better with placebo. This is an example of how evaluating safety and effectiveness for a specific demographic group can provide information that is completely different from an analysis of a diverse group as a whole.

    Shortcomings of Very Small Samples

    When the racial or ethnic group is very small, the results may not be generalizable to the larger population that those patients represent. A few outliers can have an outsized effect on the outcomes – resulting in significant differences where they do not exist. Or, real differences may be apparent but not be statistically significant because the sample lacks statistical power.

    If an analysis is conducted on a small number of patients of a particular ethnic group, any differences could easily be due to chance. For example, the graphic below shows that the new drug seems to be more effective than an older drug (40% effective compared to 30% effective) , but that difference is not statistically significant. However, if the same difference was based on a much larger sample, it would be statistically significant.

    In conclusion, when the FDA approves a medical product that has not been evaluated on a relatively large number of patients in a specific racial or ethnic group, it is not possible to conclude whether the product is safe or effective for members of that group. If the FDA does not require adequate diversity in clinical trials used as the basis for FDA approval, then the agency should only approve those products for the types of individuals studied. That precision in approval decisions would create the incentive needed for companies to improve diversity in their trials and conduct appropriate subgroup analyses.

    Reference
    1. Fox-Rawlings SR, Gottschalk LB, Doamekpor LA & Zuckerman DM. (2018) Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients? Milbank Quarterly, Vol 96 (3) 499-529.

    Dr. Diana Zuckerman Statement to CDC Advisory Committee On Breast Cancer in Young Women

    August 23, 2022

    I’m pleased to have the opportunity to provide this statement on behalf of the National Center for Health Research. We are a nonprofit research center, and our largest program is focused on cancer prevention and treatment. I previously worked at the White House office of Science and Technology Policy, the U.S. Department of Health and Human Services, the U.S. House and Senate, Harvard, and Yale. I am also a breast cancer survivor.

    Today I want to mention an issue that hasn’t been talked about: fear. Research shows that many young women are disproportionately afraid of breast cancer and that young breast cancer survivors are more afraid of recurrence than older survivors. I encourage you to think of what we can do together to help reduce that fear so that young women don’t let their fear overwhelm them as they become aware of and educated about their risks as well as their prevention and treatment options.

    Despite their fear, few women of any age know that diet and exercise help prevent breast cancer. You’ve heard today that alcohol increases the risk of breast cancer, but did you know that drinking more than 3 alcoholic beverages per week can raise the risk of breast cancer? We all know young women who drink much more than that. We should also educate young women about the link between cancer and ultra-processed foods – I’m not just talking about the usual culprits, I’m talking about sauces and many other prepared foods that we assume are healthy when we buy them at the supermarket. In addition, being overweight or obese also increases the risk of breast cancer and of recurrence, because fat cells make more estrogen. We should be educating young women about these strategies for reducing their risks, since these are changes they can control.

    Research shows that more women undergo mastectomies and bilateral mastectomies in the U.S. than most comparable countries. And yet, research shows that early-stage breast cancer patients who undergo lumpectomy (BCT) and radiation live longer with better quality of life than early-stage mastectomy patients, and a study of more than 23,000 young women with early-stage breast cancer found that the 10-year survival rate was at least as good for BCT plus radiation as for mastectomy. Research is needed to see how outcomes vary among women with specific demographic traits and risk factors, but the research available thus far is reassuring. On a personal note, as a professional in the field, I was shocked when my breast surgeon repeatedly urged me to consider a bilateral mastectomy for Stage 1 breast cancer. I had heard from many other women who had similar experiences. I am sure women who aren’t experts in the field, and especially young women, are being influenced by that kind of pressure.

    In addition to all the other important issues raised by this committee today, I want to add that we should make sure that young women understand the difference between lifetime risk of breast cancer and their annual risk of developing breast cancer. And the difference between DCIS and invasive breast cancer. Educating young women can help reduce their fear and help enable them to take the time they need to advocate for themselves based on the information needed to make the treatment decisions that are best for them.

    One last suggestion: We’ve heard many great ideas today about the information that primary care physicians, OB/GYNs, and the public need to know about young women and breast cancer, as well as prevention and treatment strategies. Wouldn’t it be great if CDC put together an education campaign on some of these key issues, to be shown on TV so it reaches a large audience?

    Who Should You Believe? A critique of the Aesthetic Society’s view of Breast Implant Illness

    By Diana Zuckerman, PhD.


    An article entitled “A Practical Guide to Managing Patients With Systemic Symptoms and Breast Implants” was published in the  Aesthetic Surgery Journal, (Volume 42, Issue 4, April 2022, Pages 397–407). This is a journal of the Aesthetic Society, which is the second largest association of plastic surgeons.  The authors are Patricia McGuire, MD, Daniel J Clauw, MD, Jason Hammer, MD, Melinda Haws, MD, and William P Adams, Jr, MD

    There are many outrageous articles denying the existence of breast implant illness, but this may be the worst since it was published after major studies documented that breast implant illness exists.  The authors are prominent plastic surgeons who are members of the Aesthetic Society and/or the American Society of Plastic Surgeons (ASPS), which are the two major associations for plastic surgeons.  All but one of the authors have financial ties to companies that make breast implants.

    The theme of the article is clearly stated in the summary: “Numerous studies have explored the possibility of an association between breast implants and systemic symptoms potentially linked to exposure to silicone. Some studies show no direct association whereas others provide insufficient scientific evidence to prove or disprove an association. Nonetheless, some patients with breast implants remain concerned about the possible role of their implants in systemic symptoms they may be experiencing. This paper provides a practical approach for plastic surgeons in managing patients with breast implants who present with systemic symptoms, including recommendations for patient counseling, clinical and laboratory assessment of symptoms, and/or referral. Integral components of patient counseling include listening attentively, providing unbiased information, and discussing the risks and benefits of options for evaluation and treatment.”

    In reality, there are numerous studies in major medical journals that show a “direct association” between breast implant illness and diagnosed diseases with similar symptoms.  But the plastic surgeons who wrote the article are saying there is no evidence.  They are also saying that since patients mistakenly think BII is real, surgeons should assure them that although BII it is not proven, research is underway to study the issue.  That gaslighting is intended to show the patients that their surgeon is open-minded.

    You might ask what is the evidence that the authors use to conclude that BII is not real?  To me as a researcher, this is the most mind-boggling part.  In addition to misquoting a 22-year old report from the Institute of Medicine – a report that is extremely outdated — and including a few individual case studies that just happen to all illustrate the authors’ view that breast implant illness isn’t real — the authors made several major errors:

    #1.  They state that “In 2019, an FDA advisory panel on breast implant safety determined that there is currently insufficient evidence of a causal relationship between breast implants and the diagnosis of rheumatologic disease or [connective tissue disease].” They footnote this statement with a document that was written by the FDA before the FDA advisory panel met in 2019 and which did not draw any such conclusions.

    #2. They state that “a number of epidemiological studies taken together are felt by many experts in the field to represent convincing evidence that there is no link between SBIs and auto-immune diseases.” The authors support that statement by listing 9 articles that they do not discuss. Almost all of the articles were funded by implant manufacturers and/or plastic surgeons, and 3 were published more than 20 years ago, based on poorly designed studies. One study was described as a study of 55,000 women, but in reality a large percentage of the patients dropped out before the study was completed.  Most outrageous of all, the last 2 studies listed actually concluded the opposite to what the plastic surgeons claimed:  The Israeli study and the Baylor study that both concluded that several autoimmune diseases with symptoms similar to BII are significantly increased after women get breast  implants.

    #3.  They mistakenly conclude that since women with saline breast implants also report BII symptoms, the symptoms are not related to the silicone shell.  This is a ridiculous statement since all breast implants have silicone shells.

    #4.  In contrast to their uncritical acceptance of poorly designed and biased studies funded by implant manufacturers and surgeons with financial ties to those implant makers, when the authors briefly mention studies showing that women with BII symptoms that improve after their implants are removed, they speculate (without evidence) that such improvement might be temporary.  It is notable that they didn’t even mention the 2021 study by Dr. Feng and her colleagues, which showed significant improvement in lung function after explant surgery.  That is no accident, since this Aesthetic Society article was published many months later.

    There are too many other careless errors in the article to list them all.  I can’t help but wonder if the authors read any of the studies they were supposedly quoting.  While urging plastic surgeons to pretend to be open-minded, the authors are anything but.  They repeatedly misrepresent research findings in order to support their biased view that the symptoms of breast implant illness are not caused by breast implants.

    In summary: This article makes it clear that the Aesthetic Society is encouraging their members to “gaslight” patients with BII, rather than help them get explanted.  Women who are seeking well-informed plastic surgeons should avoid the authors and think twice before believing anything they hear from plastic surgeons that belong to the Aesthetic Society, since the journal is published by that medical group.