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Device firms back latest MDUFA deal, while patients want more postmarket safety

The latest agreement includes higher fees for overseas firms, hiring transparency requirements and greater use of real-world evidence.

Elise Reuter, MedTech DiveAugust 10, 2026


U.S. companies will see few changes from the latest Medical Device User Fee Amendments, but overseas firms will face higher costs than under the current five-year pact.

The MDUFA negotiation process between the Food and Drug Administration and the medtech industry determines how much the agency can raise in medical device fees between 2028 and 2032.

In a public meeting Wednesday, industry leaders broadly supported the latest agreement, MDUFA VI, while patient groups called for more of an emphasis on postmarket safety.

Michelle Tarver, director of the Center for Devices and Radiological Health, said the reauthorization process was collaborative, with the draft agreement focusing on themes such as clearer communication, more consistent reviews and transparency.

The FDA will take feedback through the end of the year, with plans to submit the final package to Congress in January and for the government to pass the new budget by September 2027.

User fees increase for overseas firms

The amount medical device companies will need to pay in user fees per year will remain relatively flat, or even decrease for certain U.S. firms, said acting FDA Commissioner Kyle Diamantas.

This is offset by increases to overseas firms. Small business fee waivers will be limited to U.S. firms, and the FDA’s Center for Devices and Radiological Health is proposing higher establishment registration fees for foreign companies to account for higher expenses with inspections and imports.

[….]

Medtech lobbyist Advamed spoke in favor of the new agreement.

[….]

No hiring requirements, but more transparency

The latest agreement forgoes the current hiring targets of MDUFA V, but will include regular reporting on the number of employees and new hires at the CDRH. The reporting requirement follows a year in which the Trump administration cut thousands of workers across the FDA with little notice or explanation.

Mark Leahey, CEO of the Medical Device Manufacturers Association, said the trade group hoped to have more people doing pre-market reviews at this point in time.

[….]

TAP program becomes permanent

The total product lifecycle advisory program, or TAP, which started as a pilot under MDUFA V, will become a full-fledged program with a refined scope. The program is intended to provide access to early and frequent communications with the FDA for innovative medical devices. It also involves help designing studies so that device firms can provide the evidence that payers, such as Medicare, are seeking.

Diana Zuckerman, president of the National Center for Health Research, emphasized the importance of representation in clinical trials, adding that people with chronic disabilities often aren’t represented.

“We know that many device companies have been unhappy when their devices aren’t automatically covered by Medicare, but we also know that if a device doesn’t have clinical trials, or if it has clinical trials that don’t include people over the age of 65, it is very hard for Medicare to justify that device as reasonable and necessary,” she said.

Real-world evidence and representative data

The new agreement expands the use of real-world evidence, which can include data collected from insurance claims, health records and wearable devices. The FDA also intends to support the use of technology to recruit patients representative of a device’s intended use for clinical trials.

Patient groups and digital health advocates said the use of real-world evidence should be considered for review of devices after they have entered the market, not just premarket review.

“The best data on real-world evidence is going to be after the fact, not prior to it,” Zuckerman said, calling for the FDA to reconsider this measure. 

Benjamin Vandendriessche, chief scientific officer of Digital Medicine Society, also called for the use of real-world data postmarket.

To read the entire article, click here https://www.medtechdive.com/news/device-firms-back-latest-mdufa-deal-while-patients-want-more-postmarket-sa/827452/

Public Comment of Generation Patient, National Center for Health Research, Patient Safety Action Network, and USA Patient Network in response to the Medical Device User Fees Amendments (MDUFA) VI Stakeholders Process and Commitment Letter

August 7, 2026

Re: Docket No. FDA-2026-N-6655 for “Medical Device User Fee Amendments; Public Meeting; Request for Comments.”

We appreciated the opportunity to participate in the MDUFA Stakeholders meetings. As representatives of patient, consumer, health, and public interest organizations that do not receive funding from medical device companies, we are providing this comment to reiterate the mutual priorities that we expressed at the Stakeholders meetings in light of the MDUFA Commitment letter.

We appreciated the many presentations by FDA staff but were disappointed with the limited time allotted to ask clarifying questions and to discuss our priorities and concerns. The minutes of FDA’s meetings with industry were not detailed and generally did not reflect successful negotiations regarding our strong recommendations that, similar to the arrangement for PDUFA, user fees be available to improve post-market surveillance and that performance goals include metrics that reflect safety and efficacy goals. The fact that negotiations between CDRH and industry were apparently completed in record time and specifically rejects the proposal to support some post-market surveillance is consistent with our views that CDRH did not adequately represent our concerns. At one of the Stakeholder meetings we were told by the FDA staff that Industry said they would not allow user fees to be used for post-market surveillance, and that is consistent with the Commitment letter, which supports the use of real-world evidence (RWE) but only for premarket review. We point out that this makes no sense since almost all RWE is available after devices are cleared, classified, or approved for market.

At the MDUFA Public meeting held on August 4, 2025, invited speaker Dr. Diana Zuckerman of the National Center for Health Research reported that in the previous commitment letter, statements starting with “FDA will do x” or “FDA’s response letter will include y” were made more than 200 times, whereas there were just a few statements starting with FDA and industry will ___” and even fewer saying what industry needs to do.  We note that the new Commitment letter similarly states what FDA will do well more than 200 times, and again rarely specifies what industry must do.  Given that the FDA is a regulatory agency, the medical device industry should not be making almost all the decisions about what the FDA should do in order to get user fee funding.

Similarly, throughout the Stakeholders meetings for MDUFA VI, we heard that the patient and public health needs of members of our nonprofit organizations either were not acceptable to the Industry negotiators (such as supporting post-market safety reviews noted above and to support regulation of chatbots that provide inaccurate or misleading health or mental health advice rather than innocuous “wellness information”) or not under the jurisdiction of MDUFA negotiations because they were considered to represent policy issues. In contrast, it seemed that industry demands (such as harmonization with foreign regulatory agencies, U.S. device companies maintaining its leadership position, and not regulating widely used AI devices) and HHS demands (such as higher fees for foreign companies) were seriously negotiated regardless of whether they seemed to fit typical user fee topics of staffing levels in exchange for fees.

Public health indicators/measures 

During our MDUFA Stakeholder meetings, we were among many participants who urged that MDUFA Commitment Letter performance measures should include quality measures that evaluate the public health impact of the MDUFA program. We were also among the many that urged that user fees should also support staff that improve the quality of FDA reviews, not just the speed. We are disappointed to see that the Commitment letter does not include any such safety or effectiveness performance goals. Here are several examples of information that should be provided under MDUFA VI:

  1. How many of the recently considered PMA approvals were based on the gold standard of at least independent, randomized, blinded, controlled trials;
  2. What percentage of PMA applications is denied? What percentage is withdrawn prior to denial?
  3. What percentage of 510(k) applications is denied? What percentage is withdrawn prior to denial?
  4. How many trials submitted through the PMA pathway included a sufficient number of representative demographic subgroups (and statistical power) to evaluate whether benefits outweigh the risks for males and females; racial and ethnic minorities; and younger age groups that are still developing and more fragile patients (of any age, but especially young children and adults over 65);
  5. How many clearances, DeNovo classifications, and PMA approvals resulted in recalls, warnings, withdrawals, safety inspections, or other key safety issues within the following 10 years after approval?  Including project codes would add important safety information.
  6. How many devices cleared through the 510(k) pathway included any meaningful clinical evidence of safety or effectivenessas described explicitly in publicly available documents? How many of those were cleared through 3rd party reviewers rather than FDA staff?
  7. Other than the NEST pilot projects, provide metrics indicating full UDI compliance delineated by product code.

Other performance measures that should be considered

  1. What proportion of devices that the FDA approved or rejected through the PMA process or classified for market under the DeNovo process were reviewed by an FDA Advisory panel?
  2. How many (number and proportion) of devices given breakthrough device designation provided data on demographic information, safety, and effectiveness results that were reported in clinicaltrials.gov and other publicly available databases or documents?
  3. Clarify the distribution of all CDRH FTEs and contractors assigned to pre-market and post-market safety and effectiveness issues, including subject matter experts. What percentage of  these funds for review of MDRs, recalls, and post-approval studies are supported by MDUFA fees?

Transparency

At Stakeholder meetings, we repeatedly requested but failed to receive specific information about financial/staffing resources needed by CDRH to achieve its mission. We also asked how much of those resources have been from user fees and from appropriations. We were not given information about which activities the Centers consider the highest priorities, so were unable to share our views of those priorities.  We are pleased to see there will be efforts to increase software and AI subject matter experts but have no information about the specific numbers of those experts now or specified under MDUFA VI. This lack of transparency is unfair to Stakeholders. Here are examples of the types of information that we requested that were not made available during Stakeholder meetings:

  1. How many subject matter experts (FTE) has CDRH had on staff in January of each of 2024, 2025, and 2026, and how many of these were software experts, including AI.  How many of these positions were staffed by user fees?
  2. How many staff supported by user fees vs. appropriation funding conduct facility inspections and what proportion of inspections are done as frequently as required?
  3. How many staff paid by user fees vs. appropriations review Direct-to-Consumer ads?

Other Issues

Stakeholders raised the issue of clinical representation and lack of age-specific post-market data of underrepresented age populations, including young adults (>18) and patients over 65. FDA should ensure data collected from clinical trials and post-market surveillance is properly disaggregated by age subgroups and publicly reported (including on the Adverse Event Monitoring System (AEMS).

Concerns about New Commitment Letter Requirements for FDA

At MDUFA Stakeholder meetings, we repeatedly emphasized the patients’, consumers’ and public health experts’ lack of a voice in the MDUFA process because Stakeholders are not included in the FDA-Industry MDUFA meetings or at least be able to watch the meetings remotely in real time or videos of those meetings. Stakeholder organizations should have the opportunity to directly share their views in meetings with the FDA and industry. Instead, CDRH staff have told us that Stakeholder meetings with the FDA intended to provide us with sufficient input.

Unfortunately, despite hours spent sharing our views at this meeting, the Commitment letter does not reflect the priorities we discussed at our Stakeholder meetings, and minutes of the FDA-Industry negotiation meetings provide no evidence that most were discussed. This letter is an additional effort to seek meaningful input prior to the commitment letter being finalized.

As noted above, we are pleased that the Commitment letter includes increases in subject matter experts, but it unfortunately includes numerous examples that directly conflict with the concerns we expressed at Stakeholders meetings.  For example:

Real World Evidence

Real world evidence for medical devices relies on patients in clinical practice who use those devices and whose billing records or electronic health records can be used to provide information about the safety or effectiveness of those devices. The best use of RWE by the FDA requires that the devices be legally on the market in the U.S. and that they be studied on U.S. patients for the indications specified on the label, since non-U.S. patients, or patients using products illegally or off label could not be assumed to be representative of U.S. patients using a product that is legally on the U.S. market for the studied indication. Any RWE used to support FDA regulatory decisions should be demonstrated to be fit for purpose, relevant to the specific regulatory question, and sufficiently reliable to support valid conclusions about a device’s safety and effectiveness. It is therefore inappropriate that the Commitment letter specifies that:

  1. “The Agency will use user fee revenue for the continued development of Real-World Data (RWD) and RWE methods and policies to advance regulatory acceptance for premarket submissions, including expanded indications for use of market authorized products, market authorization of new devices and market authorization of modifications or new features for market authorized devices” and that “User fee revenue intended for RWE shall be devoted solely to advancement of premarket uses.”
  2. “By December 31, 2027, in collaboration with National Evaluation System for health Technology (NEST), FDA will update stakeholders on how the “NEST Mark: Real-World Data Sources” (hereinafter “NEST Mark”) and its application to NEST RWD/RWE contained in Data Sources can be used to support premarket submissions.”
  3. FDA will continue to advance CDRH’s RWD/RWE Training program for FDA review teams including the medical review staff. Topics will include best practices for RWE review, differences in conduct and scientific methodology between prospective clinical trials and RWE studies, and when to engage with CDRH RWE subject matter experts.

As stated earlier in this letter, we were among the many MDUFA Stakeholders that strongly recommended that user fees be used for post-market surveillance, given the lower standards for getting devices on the market, compared to prescription drugs and biologics. Claims data and electronic health records may not capture device-related adverse events, patient-reported symptoms, complications when patients receive treatment at a different hospital, clinic, or health system from where the device was implanted or prescribed, particularly when those records are not linked. In fact, patient testimony at numerous CDRH Advisory Committee meetings clearly shows that patients’ adverse events are often not captured on either claims data or EHR. While we would support the use of appropriately evaluated RWE for post-market surveillance, we find the staff time needed for the Commitment letter focus on RWE for premarket applications to be illogical and not scientifically valid, for the reasons specified above.

Deficiency Letters

We understand that it is appropriate for industry to have clear information about deficiencies in their applications, so that they can improve their submissions in the future. However, the new requirements in the MDUFA VI Commitment letter require considerable extra work for FDA staff, requiring additional specificity in the deficiency letters, allowing companies more opportunity to challenge deficiency letters without reapplying, requiring FDA to provide additional training to FDA staff regarding deficiency letters, requiring an annual audit, and requiring the FDA to develop a well-designed survey that the FDA must distribute and analyze annually. This will require a great deal of time from FDA staff  that would be likely to take them away from other important review efforts. For example, the FDA must provide:

  1. Detailed explanations of application deficiencies in writing: “FDA will provide a statement of the basis for the deficiency, consistent with the current guidance, in deficiency letters for 95% of deficiencies each fiscal year for Original PMA, Panel-Track Supplement, 510(k) and De Novo request submissions. Performance will be determined by means of annual audit conducted by QMOE.”
  2. An annual survey “for recipients of deficiency letters to gather feedback and a review of each fiscal year’s deficiency audit results and improvement subject to the MDUFA goal by September 30, 2029. The purpose of the survey will be to gather feedback on deficiency communication. When developing the survey, FDA will seek input from and discuss with industry the planned sampling methodology.’
  3. “FDA will review each fiscal year’s deficiency audit results and improvement activities with industry no later than the first quarterly meeting of the following fiscal year.” In addition to the amount of staff time required that would take away from other important staff responsibilities, these additional requirements regarding deficiency letters could serve as a disincentive to reject deficient applications, since doing so would be much more time-consuming than approving and clearing products for market despite deficient applications.

Thank you for the opportunity to share our views

NCHR Public Comment on FDA Medical Device User Fee Amendments (MDUFA) VI for 2027-2032

August 7, 2026

Re: Docket No. FDA-2026-N-6655 for “Medical Device User Fee Amendments; Public Meeting; Request for Comments.”

We appreciated the opportunity for Dr. Diana Zuckerman, President, National Center for Health Research, to serve on the patient and consumer panel at the MDUFA VI meeting on August 5, 2026, and want to more fully explain some of the issues she raised regarding the Commitment Letter. As she noted, we greatly appreciate that Dr. Tarver and the FDA staff who negotiated have made clear their commitment to patients’ voices and patient safety, but the Commitment Letter does not reflect that commitment. Instead, the MDUFA VI Commitment Letter specifies well more than 200 requirements that the FDA must do, a few dozen that medical device companies must do (including some that are joint responsibilities of industry and CDRH), and just a handful of vague mentions of safety or effectiveness.

Deficiency letters:

This section of the Commitment letter requires a great deal of staff time that is clearly disproportionate to the sponsors’ responsibilities. Over the years, we’ve seen numerous examples of where medical device companies provided obviously inadequate or flawed evidence of substantial equivalence or clinical benefit. In some cases, the sponsor did not follow CDRH published guidance or other clear suggestions of the type of evidence that would be most likely to result in approval, clearance, or certification. In those cases, it should be sufficient for a deficiency letter to briefly explain why the application was deficient (perhaps just a checklist) and not be required to justify the decision in detail, let alone have to be included in an audit and an annual survey designed to obtain feedback from the companies receiving those letters. The responsibility should not fall primarily on FDA reviewers to repeatedly explain deficiencies that could have been avoided if sponsors had followed existing FDA guidance and recommendations. Instead, MDUFA should place greater responsibility on sponsors to submit complete and scientifically adequate applications and not waste FDA staff time defending clear shortcomings in those applications, creating a disincentive for FDA staff to require appropriately high standards. For straightforward deficiencies, a concise citation to the applicable regulation, guidance, recognized standard, or other previously communicated FDA recommendation should be sufficient. This would allow FDA reviewers to devote more of their limited time to thorough reviews aimed at determining whether medical devices are safe and effective.

Clinicaltrials.gov

As part of industry’s responsibilities, the Commitment letter should state that companies will register any relevant clinical trials on clinicaltrials.gov at the time the studies are initiated, and provide meaningful, detailed data about benefits and adverse events when the study is completed. This should be included in clinicaltrials.gov before the product can be marketed. It is unfair to patients and to competitors to sell medical devices without providing their detailed clinical trial data on clinicaltrials.gov. As we stated at the MDUFA meeting on August 5, our analysis of breakthrough devices found that several clinical trials that were described in application materials to CDRH were not registered in clinicaltrials.gov, and numerous breakthrough devices that were already on the market and that had been registered on clinicaltrials.gov did not include the results of the trial or trials, even though the breakthrough devices were already on the market. Unfortunately, many of those that did have results included on clinicaltrials.gov had summarized the results in rather general terms rather than providing data on benefits and adverse events. Moreover, many results did not provide demographic information such as ages, sex, and race.

These shortcomings in publicly available information make it much more difficult for patients, physicians, researchers, and other device companies to evaluate the evidence supporting devices that are already being used in clinical practice. The MDUFA Commitment letter should therefore make timely and complete clinical trial registration and results reporting an explicit industry responsibility. At a minimum, reported results should provide enough information to evaluate benefits and adverse events and to determine whether outcomes differ among the types of patients (such as age and sex) who were studied.

Post-market data support from user fees

We were pleased that the panel members agreed about the importance of post-market data and evidence, which remains a major shortcoming of MDUFA VI. Stakeholder recommendations that MDUFA include post-market support was a major theme of the MDUFA VI Stakeholder meetings. We have worked with thousands of patients in our 27 years as a nonprofit research center, and the lack of clear, objective information about evidence regarding benefits and adverse events is patients’ greatest frustration. Patients (and their doctors) want and deserve information that can help them make informed decisions prior to using a medical device and help them determine the best medical solution if adverse events occur or if an implanted device is likely to fail in the future. Patients desperately need post-market evidence, whether from FAERS, AEMS, registries, or other RWE, and the medical device industry should show their commitment to patients and physicians by agreeing that user fees should support staff to add to post-market surveillance resources provided by federal appropriations. Instead, MDUFA VI only mentions post-market activities when it explicitly states that user fee revenue intended for RWE “shall be devoted solely to advancement of premarket uses.” We strongly recommend removing that restriction and allowing a meaningful portion of user fee funding to strengthen post-market evidence and surveillance.

Since premarket device applications provide much less evidence than those for CDER and CBER, post-market systems are essential for identifying problems that were not apparent when a device went on the market and for providing patients and physicians with evidence of safety and effectiveness over the device’s lifetime.

In addition, as part of MDUFA, industry should work with CDRH to help ensure that registry data are available to CDRH, and not controlled by medical societies or other entities that receive funding from device companies. CDRH access to those data should not depend on the cooperation of outside organizations or entities. CDRH should have timely access to sufficiently detailed registry data needed to independently evaluate device performance, adverse events, and emerging safety concerns and should make this important information available to the public. In these ways, the MDUFA Commitment letter would reflect the commitment of CDRH and the medical device industry to helping patients and physicians make informed decisions and maximize the benefits of medical devices.

Conclusions

We urge FDA and industry to revise the MDUFA VI Commitment Letter so that its requirements better reflect the shared responsibility for ensuring that medical devices are safe, effective, and supported by transparent evidence. User fees have succeeded in reducing review times dramatically and should now also focus on ensuring that FDA staff have the resources needed to ensure the quality of medical devices on the market and making essential information available to patients and medical professionals. The changes we recommend would help ensure that CDRH has the resources and support needed to carry out its essential responsibilities to patients while MDUFA also serves the needs of medical device companies.

Respectfully submitted,
National Center for Health Research,
Washington, D.C.

Thyroid Cancer: What Patients Need to Know About a Common but Often Overdiagnosed Disease

Farmin Shahabuddin, MPH and Akashleena Mallick, MD, MPH, Cancer Prevention and Treatment Fund


A Small Gland with a Big Job

Your thyroid is a small, butterfly-shaped gland at the front of your neck. If you have a noticeable Adam’s apple, it is just below that. Your thyroid makes hormones that help control your metabolism, heart rate, blood pressure, and body temperature. Thyroid cancer happens when cells in this gland begin to grow out of control. Sometimes these cells form a lump called a nodule, but most nodules are not cancerous, and not every thyroid cancer shows up as a nodule. In fact, only about 5% of thyroid nodules are cancerous. Many early thyroid cancers cause no symptoms and are found by chance, when a doctor feels a lump during a routine checkup or notices something on imaging that was done for another reason.

Thyroid cancer can develop at any age, though it is usually found in adults. Fortunately, it is less dangerous than other cancers, and about 98% of people diagnosed with thyroid cancer are alive 5 years later.1 Survival rates vary by the type and stage of the cancer, but the outlook is very good for most patients.

The Four Main Types

It’s important to know that the different types of thyroid cancer behave differently:

  • Papillary thyroid cancer is by far the most common — about 80% of patients. It usually grows slowly and responds very well to treatment.2
  • Follicular thyroid cancer accounts for about 10% of cases. It also tends to grow slowly, but it can sometimes spread to the lungs or bones.2
  • Medullary thyroid cancer is only about 4% of patients, and it can run in families through a gene change called RET.3
  • Anaplastic thyroid cancer is only about 2% of cases and is the most aggressive and fastest growing.2

Radiation and Thyroid Cancer

One known cause of thyroid cancer is exposure to radiation, especially during childhood and adolescence, when the thyroid gland is most sensitive.4 The main causes are radiation therapy to the head or neck and radiation from nuclear accidents. The good news is that most medical imaging is not a major concern, since tests like dental X-rays expose the thyroid to very small amounts of radiation. However, repeated higher-dose scans, such as CT scans of the head, neck, or chest done many times over the years, can cause thyroid cancer.4 For a closer look at how different types of radiation can affect the thyroid, see our article on Radiation and Thyroid Cancer.

Why Thyroid Cancer Is Often Overdiagnosed

Overdiagnosis in thyroid cancer occurs when very small, slow-growing tumors are correctly diagnosed as cancer but are so unlikely to grow or spread that they would never have caused symptoms, harmed a person’s health, or shortened their life if they are not treated.5 This is not a wrong diagnosis, which would be if someone is told they have cancer when they actually do not. However, not all thyroid cancers grow slowly, so any thyroid nodule or cancer diagnosis needs to be carefully evaluated by a doctor.

About 44,000 people in the United States are expected to be diagnosed with thyroid cancer every year, and about 2,300 people will die from it each year. Diagnoses have increased over the past few decades, yet the number of people dying from thyroid cancer has remained relatively stable.6 About 75% of people diagnosed with thyroid cancer are women, particularly with small papillary thyroid cancer (2 cm or less).7 One reason for this sex difference is that women use health care more often than men, increasing the chances that thyroid nodules will be found.6 Biological reasons for the difference are still being studied.6 Men may be diagnosed later because thyroid cancer is lower on the list of conditions doctors think to check for in men.6

Higher dose imaging tests, such as CT scans of the head, neck, or chest, and repeated radiation exposure over time, have also resulted in an increase in thyroid cancer diagnoses.8 These scans can spot tiny nodules that doctors may not be able to feel during a physical exam. Many scans are ordered for completely unrelated reasons, such as neck pain, dental problems, car accident injuries, or checkups for heart and lung conditions, so small thyroid nodules can be found accidentally. Once a nodule is seen on a scan, it usually leads to more tests, such as a biopsy, and sometimes to surgery. This happens because doctors cannot always predict which nodules will become dangerous and which ones never will, so they often choose to treat it just to be safe.8

Signs to Watch For

Many thyroid cancers cause no symptoms at all, especially in the early stages. When symptoms do appear, they can include a lump or swelling in the neck, hoarseness or other voice changes, trouble swallowing, pain in the front of the neck, or a cough that does not go away.9 However, these same symptoms are rarely caused by cancer, and instead due to a cold or a benign nodule, but if any of them last more than a couple of weeks, it is a good idea to go to your doctor to check.

How Thyroid Cancer Is Treated

Treatment depends on the type and stage of the cancer, as well as the person’s age and overall health.10 For a long time, surgery to remove part or all of the thyroid gland was the standard treatment for almost everyone.¹¹ That is now changing. For people with very small, slow-growing papillary cancers, many doctors now recommend active surveillance instead. This means the cancer is carefully watched with regular ultrasounds, and treatment is started only if it begins to grow or change.14 Studies have shown that many of these small cancers grow very slowly, if at all, so surgery can often be safely delayed or avoided altogether.14

Surgery is usually recommended for larger tumors, cancers that have spread beyond the thyroid, or the more aggressive types, such as medullary or anaplastic thyroid cancer.10 When surgery is needed, it can cause harm. The nerves that control the vocal cords can sometimes be bruised or injured, leading to a weaker voice or, in rare cases, trouble breathing.¹¹ The parathyroid glands, four tiny glands on the back of the thyroid that control calcium levels, can also be accidentally damaged, leaving some people with muscle cramps or tingling in the hands and feet. When these glands are injured, the body can no longer keep calcium at a healthy level on its own, so some people will need to take calcium and vitamin D pills for the rest of their lives.¹¹ People who have their whole thyroid removed also need a daily hormone replacement pill for the rest of their lives, and determining the right dose can take months or even years.¹³ Too low a dose can cause tiredness, weight gain, and trouble concentrating, while too high a dose can cause a fast heartbeat, anxiety, trouble sleeping, and weaker bones over time.¹³

Surgery is not always the only treatment. Some patients also receive radioactive iodine therapy, which uses radioactive iodine to destroy any leftover thyroid cells, and this can cause side effects such as dry mouth, changes in taste, and a temporary drop in the body’s ability to fight infection.¹² For advanced or aggressive cancers, doctors may also recommend external beam radiation, targeted drug therapy, or, in rare cases, chemotherapy.15  On top of the physical effects, many survivors report lasting fatigue, anxiety, depression, and a sense of uncertainty about the future, even years after treatment ends.16

Some physicians still tend to recommend surgery even when active surveillance would be a reasonable option, often because they or their patients feel more at ease knowing the cancer has been removed.17  But peace of mind can come at a real cost when the treatment itself causes harm that the cancer never would have. That is why many thyroid cancer specialists now encourage a more cautious, individualized approach for small, slow-growing tumors.

Questions Worth Asking Your Doctor

If you or a loved one has been diagnosed with thyroid cancer, it is a good idea to come to appointments prepared.  We agree with the American Cancer Society’s recommended questions:18

  • Is my cancer the slow-growing kind, or is it more aggressive?
  • Do I need treatment right away, or could active surveillance be an option for me?
  • What are the risks and benefits of treating this cancer now versus monitoring it?
  • What are the possible short-term and long-term effects of each treatment?
  • How will treatment affect my daily life, my voice, and my energy? And what does recovery usually look like?

The Bottom Line

Thyroid cancer is common and is rarely life-threatening, so most patients do not need surgery. For many people, especially those with small, slow-growing papillary cancers, careful monitoring may enable you to live just as long as you would with surgery while avoiding the side effects described above. The best decisions come from honest conversations between patients, families, and doctors, based on the most up-to-date evidence and guided by what matters most to you.

References

  1. National Cancer Institute. (2024). SEER cancer stat facts: Thyroid cancer. Surveillance, Epidemiology, and End Results Program. https://seer.cancer.gov/statfacts/html/thyro.html
  2. American Cancer Society. (2024). Survival rates for thyroid cancer. https://www.cancer.org/cancer/types/thyroid-cancer/detection-diagnosis-staging/survival-rates.html
  3. Mathiesen, J. S., Effraimidis, G., Rossing, M., Rasmussen, Å. K., Hoejberg, L., Bastholt, L., Godballe, C., Oturai, P., & Feldt-Rasmussen, U. (2023). Multiple endocrine neoplasia type 2 and medullary thyroid carcinoma. The Journal of Clinical Endocrinology & Metabolism, 108(2), 271–282. https://academic.oup.com/jcem/article/108/2/271/6795262
  4. Smith-Bindman, R., Chu, P. W., Azman Firdaus, H., Stewart, C., Malekhedayat, M., Alber, S., Bolch, W. E., Mahendra, M., Berrington de González, A., & Miglioretti, D. L. (2025). Projected lifetime cancer risks from current computed tomography imaging. JAMA Internal Medicine, 185(6), 710–719. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2832778
  5. Papaleontiou, M., & Haymart, M. R. (2020). Too much of a good thing? A cautionary tale of thyroid cancer overdiagnosis and overtreatment. Thyroid, 30(5), 651–652. https://doi.org/10.1089/thy.2020.0080
  6. LeClair, K., Bell, K. J. L., Furuya-Kanamori, L., Doi, S. A., Francis, D. O., & Davies, L. (2021). Evaluation of gender inequity in thyroid cancer diagnosis: Differences by sex in US thyroid cancer incidence compared with a meta-analysis of subclinical thyroid cancer rates at autopsy. JAMA Internal Medicine, 181(10), 1351–1358. https://doi.org/10.1001/jamainternmed.2021.4804
  7. Chen, D. W., Lang, B. H. H., McLeod, D. S. A., Newbold, K., & Haymart, M. R. (2023). Thyroid cancer. The Lancet, 401(10387), 1531–1544. https://doi.org/10.1016/S0140-6736(23)00020-X
  8. Li, M., Dal Maso, L., Pizzato, M., & Vaccarella, S. (2024). Evolving epidemiological patterns of thyroid cancer and estimates of overdiagnosis in 2013–2017 in selected countries. JAMA Network Open, 7(8), e2429045. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2845450
  9. American Cancer Society. (2024). Signs and symptoms of thyroid cancer. https://www.cancer.org/cancer/types/thyroid-cancer/detection-diagnosis-staging/signs-symptoms.html
  10. American Cancer Society. (2024). Treatment of thyroid cancer, by type and stage. https://www.cancer.org/cancer/types/thyroid-cancer/treating/by-stage.html
  11. American Cancer Society. (2024). Surgery for thyroid cancer. https://www.cancer.org/cancer/types/thyroid-cancer/treating/surgery.html
  12. American Cancer Society. (2024). Radioactive iodine (radioiodine) therapy for thyroid cancer. https://www.cancer.org/cancer/types/thyroid-cancer/treating/radioactive-iodine.html
  13. American Cancer Society. (2024). Thyroid hormone therapy. https://www.cancer.org/cancer/types/thyroid-cancer/treating/thyroid-hormone-therapy.html
  14. Tuttle, R. M., Fagin, J. A., Minkowitz, G., Wong, R. J., Roman, B., Patel, S., Untch, B., Ganly, I., Shaha, A. R., Shah, J. P., Pace, M., Li, D., Bach, A., Lin, O., Whiting, A., Ghossein, R., Landa, I., Sabra, M., Boucai, L., … Sherman, E. (2022). Active surveillance of papillary thyroid cancer: Frequency and time course of the six most common tumor volume kinetic patterns. JAMA Oncology, 8(11), 1588–1596. https://jamanetwork.com/journals/jamaoncology/fullarticle/2796440
  15. American Cancer Society. (2024). Targeted drug therapy for thyroid cancer. https://www.cancer.org/cancer/types/thyroid-cancer/treating/targeted-therapy.html
  16. Applewhite, M. K., James, B. C., Kaplan, S. P., Angelos, P., Kaplan, E. L., Grogan, R. H., & Aschebrook-Kilfoy, B. (2016). Quality of life in thyroid cancer survivors: A systematic review. Thyroid, 26(11), 1533–1541. https://journals.sagepub.com/doi/10.1089/thy.2015.0098
  17. Haymart, M. R., Miller, D. C., & Hawley, S. T. (2021). Physician perspectives on the treatment of low-risk thyroid cancer. JAMA Network Open, 4(12), e2140841. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2791285
  18. American Cancer Society. (2024). Questions to ask your doctor about thyroid cancer. https://www.cancer.org/cancer/types/thyroid-cancer/detection-diagnosis-staging/talking-with-doctor.html

 

Radiation and Thyroid Cancer: What Every Patient Should Know Before the Next Scan

Farmin Shahabuddin, MPH and Akashleena Mallick, MD, MPH, Cancer Prevention and Treatment Fund


Thyroid cancer diagnoses have increased dramatically in recent years, and experts are asking why. The good news is that doctors now use better imaging tests that can find very small thyroid tumors. The bad news is that some of these very small tumors might never cause health problems even if they are not treated.

Another possible reason for the increase in thyroid cancer could be because radiation was commonly used for minor childhood issues decades ago, such as swollen tonsils and acne. This resulted in a surge of thyroid cancer when those children became adults. More recently, experts have looked at whether repeated exposure to medical imaging tests that use radiation, such as CT scans, dental X-rays, and other scans, might also increase the chance of thyroid cancer over time. Fortunately, medical imaging today uses less radiation than it did in the past due to improved technology1, and the use of lead aprons and other protections has further reduced exposure.

In this article, we will let you know what the most recent research shows and what you can do to reduce any added chance of thyroid cancer caused by X-rays, CT scans, or other medical scans, or other radiation, while still getting the care you need.

The thyroid is a small, butterfly-shaped gland in the front of the neck. It is just below your Adam’s apple, although the latter may not be visible. The thyroid makes hormones that help regulate metabolism, heart rate, blood pressure, and body temperature. Since the thyroid sits close to the surface of the skin, it is sensitive to radiation.2 For more on the gland and how cancer develops there, see our thyroid cancer article here.

What Is Radiation in Medical Imaging?

Radiation can come from sunlight or from human-made sources like medical imaging. Thyroid cancer can develop from many sources of radiation, such as past cancer treatment to the head or neck, nuclear accidents, and workplaces that use radioactive materials. For more information, see Everything You Ever Wanted to Know About Radiation and Cancer but Were Afraid to Ask.

In medicine, X-rays are the most common form of radiation used to take pictures inside the body. Other tests using radiation that we will discuss in this article include X-rays of the head and neck, CT scans, dental X-rays, dental CT scans, and mammography. Each test uses a different amount of radiation, and some tests expose the thyroid to more radiation than others. When imaging is done close to the thyroid (as described later in this article), patients can ask for a ‘thyroid shield’ as described below, which is a lead cover placed over the neck to keep radiation from reaching the thyroid.

Radiation and Thyroid Cancer in Children and Women

In 2023, about 2.5 million CT scans were performed on children in the U.S. A study projected that the radiation from these scans would eventually lead to about 3,500 cases of thyroid cancer in those children.3 The thyroid is particularly sensitive to radiation during childhood and adolescence, when the gland is most active. Cells in the thyroid divide more rapidly in younger patients, and children have more years ahead in which a cancer could develop.1 For these reasons, parents and caregivers may want to ask their doctors whether a test without radiation could be used instead.

Women are also more sensitive to radiation from imaging, which may help explain why thyroid cancer is diagnosed three times more often in women than men.4 The reasons are not yet completely understood. For more on women and thyroid cancer, see our thyroid cancer article here.

X-rays

Regular X-rays of the head, neck, chest, or upper spine deliver a small amount of radiation to the thyroid, though usually much less than a CT scan. For most patients, a single X-ray carries a small added chance of thyroid cancer.1 Repeated X-rays of the same body part over many years can increase the chance of thyroid cancer over time.

Before an X-ray, it is reasonable to ask whether a recent image on file, or a test without radiation, could give the same information. For X-rays of areas close to the neck, a thyroid shield can be requested to help reduce exposure to the thyroid.1

CT scans

A CT scan takes many X-ray pictures from different angles to combine them into a detailed image. As a result, a CT scan delivers more radiation than a regular X-ray. CT scans of the head, neck, chest, and upper spine expose the thyroid to the most radiation since the thyroid gland is located close to those areas of the body.2

When a CT scan does not include the neck itself, a thyroid shield can be helpful in lowering exposure to the thyroid, and patients can ask their healthcare professional whether one can be used.1

Before a CT scan, it is reasonable to ask your healthcare professional:

  • Is the scan truly needed?
  • Could a test without radiation, such as an MRI or ultrasound, give the same or better information?
  • Can a thyroid shield be used to protect the thyroid when the scan does not include the neck?

Dental CT scans

Cone beam CT (CBCT), also known as a dental CT scan, is a newer scan that uses X-rays to take 3-D pictures of the teeth, jaw, and sinuses. Dentists may use it before braces, dental implants, or jaw surgery. CBCT delivers much less radiation than a medical CT scan, but more than a regular dental X-ray. Some of this radiation can reach the thyroid when the scan includes the lower jaw.5

In February 2024, the American Dental Association (ADA) updated its guidance to no longer recommend the routine use of thyroid shields during dental imaging, including CBCT, because the shield can block part of the image and lead to a repeat scan, which means more radiation overall.7 The ADA notes that modern equipment and restricting the size of the X-ray beam protect patients more effectively than a shield does. A patient who prefers a shield can still request one, and the dentist should consider whether using one would increase the chance of needing a repeat scan.7

Dental X-rays

Previous concerns about dental X-rays mostly came from studies of machines used before 1970, when the equipment delivered more radiation than today’s machines. Today, dental X-ray technology has improved, and many dental offices use digital sensors that lower radiation exposure even further. Due to these changes, a 2025 review found that current evidence does not clearly show that modern dental X-rays increase a person’s chance of developing thyroid cancer. ⁷ However, dental X-rays should still be used only when they are needed for diagnosis or treatment.

Mammograms

A mammogram is an X-ray of the breast.8 Since breasts are far from the thyroid gland, the chance of a 40-year-old woman developing thyroid cancer from one mammogram is about 6 in 1 billion. Even with yearly mammograms from age 40 to age 80 (which is more frequently than is recommended), the chance of developing thyroid cancer remains extremely low, about 1 in 18 million.9   That is why thyroid shields are not recommended during a mammogram.

The Bottom Line

CT scans expose the thyroid to more radiation than dental X-rays, dental CT scans, mammograms, and X-rays. However, the chance of thyroid cancer increases with the number of scans. Children, adolescents, and women are more sensitive to medical imaging radiation, so extra care is needed. For medical X-rays and CT scans of areas close to the neck, a thyroid shield can be requested. For dental X-rays, dental CT scans, and mammograms, current guidance does not recommend a thyroid shield for routine use, since it can interfere with the image and require a repeat scan. However, to reduce exposure to radiation, it makes sense to ask your doctor whether a scan is truly needed and weigh the benefits against the harms.

References

  1. American Cancer Society. (2026, April 23). Understanding radiation risk from imaging tests. https://www.cancer.org/cancer/diagnosis-staging/tests/imaging-tests/understanding-radiation-risk-from-imaging-tests.html
  2. Saenko, V., & Mitsutake, N. (2024). Radiation-related thyroid cancer. Endocrine Reviews, 45(1), 1–29. https://doi.org/10.1210/endrev/bnad022
  3. American Thyroid Association. (2025, September). Do CT scans increase the risk of thyroid cancer? Clinical Thyroidology for the Public, 18(9), 5. https://www.thyroid.org/patient-thyroid-information/ct-for-patients/september-2025/vol-18-issue-9-p-5/
  4. Cao, C.-F., Ma, K.-L., Shan, H., Liu, T.-F., Zhao, S.-Q., Wan, Y., Zhang, J., & Wang, H.-Q. (2022). CT scans and cancer risks: A systematic review and dose-response meta-analysis. BMC Cancer, 22, 1238. https://doi.org/10.1186/s12885-022-10310-2
  5. Lai, S. T. T., & Bauer, A. J. (2025). Approach to the pediatric patient with thyroid nodules. The Journal of Clinical Endocrinology & Metabolism, 110(8), 2339–2352. https://doi.org/10.1210/clinem/dgaf090
  6. Yeom, H. G., Kim, J. E., Huh, K. H., Yi, W. J., Heo, M. S., & Lee, S. S. (2022). Impact of thyroid gland shielding on radiation doses in dental cone beam computed tomography. Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology, 134(6), 801–812. https://doi.org/10.1016/j.oooo.2022.05.005
  7. Holmström, L., Tranæus, S., Hultin, M., Mejare, I., Kadesjö, N., & Shi, X.‑Q. (2025). Negative health effects of dental x‑rays: A systematic review. Acta Odontologica Scandinavica, 84, 328–340. https://doi.org/10.2340/aos.v84.43673
  8. Centers for Disease Control and Prevention. (n.d.). About mammograms. U.S. Department of Health and Human Services. Retrieved April 28, 2026, from https://www.cdc.gov/breast-cancer/about/mammograms.html
  9. Stempniak, M. (2022, February 10). Misinformation on mammography thyroid shielding goes viral, presenting opportunity for radiologist clarification. Radiology Business. https://radiologybusiness.com/topics/medical-practice-management/mammography-thyroid-shielding-radiologist

Exercise, Reducing Your Likelihood of Cancer, and Life After Treatment

Farmin Shahabuddin, MPH, Cancer Prevention and Treatment Fund


Most people know that exercise is good for your heart and overall health. What many people do not know is that exercise may also reduce the likelihood of developing cancer and help cancer survivors live longer after treatment ends. Whether you have never had cancer or finished treatment and want to lower your chances of it coming back, physical activity is one of the most important things you can do.

Can Exercise Reduce Your Likelihood of Getting Cancer?

Research shows that people who are physically active are less likely to develop many types of cancer. A study of 1.4 million people found that those who exercised regularly were less likely to develop 13 types of cancer, including breast, colon, liver, kidney, stomach, and bladder cancer.1

A 2025 study tracked activity of more than 85,000 adults using wearable devices. The most active people were about 26% less likely to develop cancer than the least active.2 Even light activities such as errands and household chores made a difference. Taking more steps each day also helped. For example, people who took 9,000 steps a day were about 16% less likely to develop cancer than those who took 5,000.

Cancer usually is growing before it is diagnosed, and being active in the year before a diagnosis is also beneficial according to a 2025 study of more than 28,000 people with stage 1 cancers who had activity records for the year before their diagnosis.3 Those who exercised as little as 60 minutes per week were 27% less likely to have their cancer progress to a more advanced stage  and were 47% less likely to die, compared to those who were not active.3 Five years after diagnosis, about 91% of the most active people were still alive, compared to about 84% of those who had not been active.3

Why Does Exercise Lower the Likelihood of Cancer?

Exercise may lower the likelihood of cancer in several ways. It lowers hormones such as estrogen and insulin that can encourage cancer cells to grow.4,5,6 It helps the immune system spot and destroy abnormal cells.6 It also helps people maintain a healthy weight, which matters because being overweight contributes to an estimated 14% to 20% of cancer deaths in the U.S.6 Exercise also helps move food through the digestive system faster, which reduces the time that the lining of the intestines is exposed to potentially harmful substances.

Scientists are still learning more about why exercise can prevent cancer. A 2026 lab study found that even 10 minutes of exercise changed the blood in ways that helped colon cancer cells repair damaged DNA.7 While more research is needed, this adds to the evidence that exercise sends signals throughout the body that may help fight cancer.

How Much Exercise Do You Need?

The U.S Department of Health and Human Services physical activity guidelines recommend that all adults get 150 to 300 minutes per week of moderate activity such as brisk walking, or 75 to 150 minutes of vigorous activity such as running. Adults should also do muscle strengthening exercises at least 2 days per week.6 These guidelines are not specific to cancer prevention. Of course, any amount of physical activity is better than none. The key is to start where you are and gradually build up.

Exercise for Cancer Survivors After Treatment

Exercise does not just matter before a cancer diagnosis. It can also be helpful during cancer treatment (see this link for our article on that). Regular exercise after you have finished cancer treatment, can also help you live longer and feel better, with fewer side effects from treatment, including less fatigue.8,9 Survivors who exercise regularly are less likely to die from cancer and are more likely to live longer than those who do not exercise.[10-14] It does not matter if you were fit before you got diagnosed. What matters is that you start exercising now.

Since exercise improves the immune system, cancer survivors who exercise regularly lower their chances of the cancer returning. A large 2026 study followed more than 17,000 cancer survivors for an average of about 11 years. 15 The survivors had bladder, endometrial, lung, oral cavity, ovarian, or rectal cancer. The activities studied included brisk walking, cycling, and swimming.      The study compared survivors at different activity levels to those who did no physical activity at all. It found that even small amounts of exercise that were considerably less than the recommended physical activity guidelines, were linked to longer survival. Bladder cancer survivors who did relatively low levels of exercise were 33% less likely to die from their cancer, endometrial cancer survivors were 38% less likely, and lung cancer survivors were 44% less likely, compared to those who did no physical activity.

Survivors who met or exceeded the recommended guidelines saw even greater benefits. Endometrial cancer survivors who met the guidelines were 60% less likely to die from their cancer, and lung cancer survivors were 62% less likely, compared to those who did no exercise. Oral and rectal cancer survivors who doubled the recommended amount of activity were 61% less likely to die of oral cancer and 43% less likely to die of rectal cancer.

Sitting Less Matters Too

Along with exercising more, sitting less can also make a difference. A 2022 study followed over 1,500 cancer survivors ages 40 and over for an average of 4.5 years. Survivors who exercised at least 150 minutes per week were less likely to die than those who did not exercise. 16  Survivors who sat for more than 8 hours a day were also more likely to die than those who sat less than 4 hours per day. Those who both did not exercise and sat more than 8 hours per day had the worst outcomes of all.”

A 2020 study followed 8,000 adults aged 45 and older for about 5 years. People who sat the most were more likely to die from cancer than those who sat the least.17 Replacing just 30 minutes of sitting per day with moderate to vigorous activity was linked to a 31% lower chance of dying from cancer. Even replacing that sitting time with light activity like standing or gentle walking was linked to an 8% lower chance of dying.

What Kind of Exercise Should I Do?

Aerobic activity of light to moderate intensity was the most common type of exercise studied in cancer patients. Combining aerobic exercise with walking and resistance training, such as lifting weights or resistance bands, led to greater health benefits than aerobic activity alone.11,13 Lifting weights refers to any weights, even just a few pounds. Do not assume you need barbells and large muscles.

Walking is the easiest way to start. The greatest benefit comes from walking at an average speed, about a 20-minute mile, for 3 to 5 hours per week.8 Even walking just 1 hour per week showed improvements over no physical activity at all.

The most important thing is to make it a habit. Start small by taking the stairs instead of the elevator or walking after dinner each evening. It is better to start small and keep it up than to try to do too much and give up. Do not miss the chance to get at least some benefit from this easy, free way to fight cancer.

The Bottom Line

Exercise is a powerful, free tool. For people who have never had cancer, regular physical activity is linked to a lower likelihood of developing many types of cancer. For survivors who have finished treatment, exercise lowers the chances of cancer coming back and helps people live longer. Being active before a diagnosis also improves outcomes if cancer does occur. Even if you were not active before, starting to exercise afterward still helps. Try to walk 3 to 5 hours a week at an average pace, about 1 mile per 20 minutes. Try to sit less and move more throughout the day. Even a little exercise is better than none. It is never too late to begin.

To read about the benefits of exercise during cancer treatment, click here: https://stopcancerfund.org/pz-diet-habits-behaviors/exercise-cancer-treatment-benefits/

References

  1. Moore, S. C., Lee, I. M., Weiderpass, E., Campbell, P. T., Sampson, J. N., Kitahara, C. M., Keadle, S. K., Arem, H., Berrington de Gonzalez, A., Hartge, P., Adami, H. O., Blair, C. K., Borch, K. B., Boyd, E., Check, D. P., Fournier, A., Freedman, N. D., Gunter, M., Johansson, M., & Patel, A. V. (2016). Association of leisure-time physical activity with risk of 26 types of cancer in 1.44 million adults. JAMA Internal Medicine, 176(6), 816–825. https://doi.org/10.1001/jamainternmed.2016.1548
  2. National Cancer Institute. (2025, March 26). Cancer risk decreases with more physical activity [Press release]. https://www.cancer.gov/news-events/press-releases/2025/light-intensity-physical-activity-cancer-risk
  3. Patricios, J., Constantinou, D., Goff, P., Kolbe-Alexander, T., Capostagno, B., Gossage, S., & van Rensburg, D. C. J. (2025). Regular physical activity before cancer diagnosis may lower progression and death risks. British Journal of Sports Medicine. https://doi.org/10.1136/bjsports-2024-108699
  4. Key, T., Appleby, P., Barnes, I., & Reeves, G. (2002). Endogenous sex hormones and breast cancer in postmenopausal women: Reanalysis of nine prospective studies. Journal of the National Cancer Institute, 94(8), 606–616. https://doi.org/10.1093/jnci/94.8.606
  5. McTiernan, A., Tworoger, S. S., Ulrich, C. M., Yasui, Y., Irwin, M. L., Rajan, K. B., Sorensen, B., Rudolph, R. E., Bowen, D., Stanczyk, F. Z., Potter, J. D., & Schwartz, R. S. (2004). Effect of exercise on serum estrogens in postmenopausal women: A 12-month randomized clinical trial. Cancer Research, 64(8), 2923–2928. https://doi.org/10.1158/0008-5472.CAN-03-3393
  6. National Cancer Institute. (n.d.). Physical activity and cancer fact sheet. U.S. Department of Health and Human Services. https://www.cancer.gov/about-cancer/causes-prevention/risk/obesity/physical-activity-fact-sheet
  7. Orange, S. T., Dodd, E., Nath, S., Bowden, H., Jordan, A. R., Tweddle, H., Hedley, A., Chukwuma, I., Hickson, I., & Sharma Saha, S. (2025). Exercise serum promotes DNA damage repair and remodels gene expression in colon cancer cells. International Journal of Cancer. https://doi.org/10.1002/ijc.70271
  8. Holmes, M. D., Chen, W. Y., Feskanich, D., Kroenke, C. H., & Colditz, G. A. (2005). Physical activity and survival after breast cancer diagnosis. JAMA, 293(20), 2479–2486. https://doi.org/10.1001/jama.293.20.2479
  9. McNeely, M. L., Campbell, K. L., Rowe, B. H., Klassen, T. P., Mackey, J. R., & Courneya, K. S. (2006). Effects of exercise on breast cancer patients and survivors: A systematic review and meta-analysis. Canadian Medical Association Journal, 175(1), 34–41. https://doi.org/10.1503/cmaj.051073
  10. Meyerhardt, J. A., Heseltine, D., Niedzwiecki, D., Hollis, D., Saltz, L. B., Mayer, R. J., Thomas, J., Nelson, H., Whittom, R., Hantel, A., Schilsky, R. L., & Fuchs, C. S. (2006). Impact of physical activity on cancer recurrence and survival in patients with stage III colon cancer: Findings from CALGB 89803. Journal of Clinical Oncology, 24(22), 3535–3541. https://doi.org/10.1200/JCO.2006.06.0863
  11. Fong, D. Y. T., Ho, J. W. C., Hui, B. P. H., Lee, A. M., Macfarlane, D. J., Leung, S. S. K., Cerin, E., Chan, W. Y. Y., Leung, I. P. F., Lam, S. H. S., Taylor, A. J., & Cheng, K. K. (2012). Physical activity for cancer survivors: Meta-analysis of randomized controlled trials. BMJ, 344, e70. https://doi.org/10.1136/bmj.e70
  12. Meyerhardt, J. A., Giovannucci, E. L., Holmes, M. D., Chan, A. T., Chan, J. A., Colditz, G. A., & Fuchs, C. S. (2006). Physical activity and survival after colorectal cancer diagnosis. Journal of Clinical Oncology, 24(22), 3527–3534. https://doi.org/10.1200/JCO.2006.06.0855
  13. Spence, R. R., Heesch, K. C., & Brown, W. J. (2010). Exercise and cancer rehabilitation: A systematic review. Cancer Treatment Reviews, 36(2), 185–194. https://doi.org/10.1016/j.ctrv.2009.11.003
  14. Sternfeld, B., Weltzien, E., Quesenberry, C. P., Jr., Castillo, A. L., Kwan, M., Slattery, M. L., & Caan, B. J. (2009). Physical activity and risk of recurrence and mortality in breast cancer survivors: Findings from the LACE study. Cancer Epidemiology, Biomarkers & Prevention, 18(1), 87–95. https://doi.org/10.1158/1055-9965.EPI-08-0595
  15. Rees-Punia, E., Teras, L. R., Newton, C. C., Gapstur, S. M., Patel, A. V., Gaudet, M. M., Islami, F., Campbell, P. T., & McCullough, M. L. (2026). Leisure-time physical activity and cancer mortality among cancer survivors. JAMA Network Open, 9(2), e2556971. https://doi.org/10.1001/jamanetworkopen.2025.56971
  16. Cao, C., Friedenreich, C. M., & Yang, L. (2022). Association of daily sitting time and leisure-time physical activity with survival among US cancer survivors. JAMA Oncology, 8(3), 395–403. https://doi.org/10.1001/jamaoncol.2021.6590
  17. Gilchrist, S. C., Howard, V. J., Akinyemiju, T., Judd, S. E., Cushman, M., Hooker, S. P., & Diaz, K. M. (2020). Association of sedentary behavior with cancer mortality in middle-aged and older US adults. JAMA Oncology, 6(8), 1210–1217. https://doi.org/10.1001/jamaoncol.2020.2045

The Benefits of Exercise During Cancer Treatment

Farmin Shahabuddin, MPH, Cancer Prevention and Treatment Fund


You may have heard that regular exercise can reduce your likelihood of developing cancer, but did you know it is also good for cancer patients who are going through treatment?

Is Exercise Good for Everyone with Cancer?

If you or someone you love is going through cancer treatment, you may wonder whether exercise is safe or even possible. The answer, according to a growing body of research, is yes. In 2022, the American Society of Clinical Oncology (ASCO) formally recommended that cancer doctors encourage their patients to do regular physical activity during treatment.1

Until recently, most of the research on exercise and cancer focused on patients with breast or colon cancer. However, newer studies have shown that exercise benefits people with many different types of cancer.2,3 A large 2025 review combined data from 151 studies involving nearly 1.5 million cancer patients with breast, prostate, lung, colorectal, and skin cancers. Across all these cancer types, patients who were physically active were less likely to die from their cancer than those who were not active.4

Of course, exercising during treatment can feel difficult. Cancer and its treatments can cause fatigue, pain, and other symptoms that make physical activity challenging. But exercise does not have to be intense to be helpful. Even gentle stretching, short walks, or light movement throughout the day can make a difference. A 2022 review of 15 clinical trials found that even patients with advanced cancers who participated in exercise programs at a low level of effort saw improvements in fatigue, independence, quality of life, and sleep.5

How Does Exercise Help Cancer Patients?

You may be wondering why exercise helps during cancer treatment. Researchers have found that it works in several ways. Exercise lowers levels of certain hormones, such as estrogen, that can fuel the growth of some cancers, and it reduces inflammation throughout the body, which is believed to play a role in how cancer develops and spreads.⁶ A 2026 clinical trial also found that patients who followed a simple home-based walking and resistance band program had a healthier immune response during chemotherapy, which may explain why they experienced fewer side effects like mental fatigue and difficulty thinking.⁷

Physical Benefits of Exercise During Treatment

The ASCO review found that exercise during cancer treatment led to improvements in heart and lung fitness, muscle strength, and energy levels.1 Other studies have found that cancer patients who exercise during treatment have lower body fat, lower blood pressure, and stronger bones, which means fewer fractures.8,9 Patients who exercised also reported less nausea and better sleep.8 The most commonly reported improvement was reduced fatigue, which is one of the most challenging side effects of cancer treatment.8,9

Beyond helping reduce side effects, exercise may also help cancer patients live longer. A 2025 review that followed nearly 1.5 million cancer patients for 6 months to several years after their diagnosis found that those who were physically active were less likely to die from their cancer than those who were not active. The benefit was seen across several types of cancer. Breast cancer patients who exercised were 31% less likely to die from their cancer, followed by colorectal cancer patients at 29%, prostate cancer patients at 27%, and lung cancer patients at 24%, compared to patients with those cancers who did not exercise.

Mental and Emotional Benefits

Cancer patients who exercised during treatment also reported improved mental and emotional well-being.2 They frequently reported a higher quality of life, less anxiety, and felt more motivated.8 Cancer patients over the age of 80 who exercised regularly during their weeks or months of treatment reported fewer memory problems.10 A review of studies that was published in 2025 noted that exercise during treatment can help improve emotional health, reduce symptoms of depression, and support overall psychological well-being across many cancer types.6

Exercise May Help Relieve “Chemo Brain”

“Chemo brain” (also known as chemo fog) is a common side effect of chemotherapy that affects many cancer patients receiving chemotherapy. Common symptoms include having trouble learning new tasks, remembering names, paying attention, and concentrating. Chemo brain can be upsetting and make everyday life much harder.

Fortunately, research suggests that exercise can help. A 2021 study found that patients who averaged  2.5 to 5 hours of moderate exercise (like brisk walking) per week or 1.5 to 2.5 hours of vigorous exercise (such as running) per week before, during, and after chemotherapy for breast cancer were less likely to report chemo brain symptoms than patients who did not exercise.11

A 2026 clinical trial tested a home-based exercise program in 687 cancer patients at 20 cancer centers across the United States.7 All patients were about to start chemotherapy. They were randomly assigned to either follow the exercise program or receive their usual care. The exercise program included daily walking and resistance band exercises at a light to moderate level of effort for 6 weeks. Before starting chemotherapy, patients in both groups were walking about 4,000 to 5,000 steps a day from their normal daily activities. After 6 weeks, patients who did not follow the exercise program were walking about half as many steps, while patients on the exercise program kept up their usual amount of walking.

Among patients receiving chemotherapy in 2-week cycles, those on the exercise program reported less overall cognitive impairment and less mental fatigue compared to those who did not exercise.7 In the exercise group, 92% of patients said they had a more positive view of exercise after the study, and 97% said they would recommend the program to other patients receiving chemotherapy.⁷

What Kind of Exercise Should I Do?

Light to moderate physical activity was the most common type of exercise studied in cancer patients.1,2 Combining activities that get your heart rate up, like walking or swimming, with activities that build muscle strength, like using light weights or resistance bands, led to greater health benefits than either type alone.2,9 The 2026 clinical trial described above found that a simple program of daily walking plus resistance band exercises, done at home without a gym or special equipment, was enough to make a meaningful difference during chemotherapy.7 Walking is the easiest way to start. Studies show that walking 3 to 5 hours per week provides the greatest benefit, but even 1 hour of walking per week showed improvements over no activity at all.3

The most important thing is to make exercise a habit. Start small by taking the stairs instead of the elevator or taking a walk during the day if you can. It is better to start small and keep it up than to try to do too much and give up. Do not miss the chance to get at least some benefit from this easy, free way to fight cancer.

The Bottom Line

Cancer patients who engage in even light or moderate physical activity regularly during treatment can expect fewer side effects, including less fatigue, fewer problems with concentration and memory, and better overall fitness and health. A home-based program of walking and resistance band exercises has been shown to reduce chemo brain and mental fatigue during chemotherapy. Exercise benefits people with all types of cancer, including those with advanced disease. Even a little exercise is better than none, and it is never too late to begin.

References

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  2. Fong, D. Y. T., Ho, J. W. C., Hui, B. P. H., Lee, A. M., Macfarlane, D. J., Leung, S. S. K., Cerin, E., Chan, W. Y. Y., Leung, I. P. F., Lam, S. H. S., Taylor, A. J., & Cheng, K.-K. (2012). Physical activity for cancer survivors: Meta-analysis of randomised controlled trials. BMJ, 344, e70. https://doi.org/10.1136/bmj.e70
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  4. Ungvari, Z., Fekete, M., Varga, P., Munkácsy, G., Fekete, J. T., Lehoczki, A., Buda, A., Kiss, C., Ungvari, A., & Győrffy, B. (2025). Exercise and survival benefit in cancer patients: Evidence from a comprehensive meta-analysis. GeroScience, 47(3), 5235–5255. https://doi.org/10.1007/s11357-025-01647-0
  5. Rodríguez-Cañamero, S., Cobo-Cuenca, A. I., Carmona-Torres, J. M., Pozuelo-Carrascosa, D. P., Santacruz-Salas, E., Rabanales-Sotos, J. A., Cuesta-Mateos, T., & Laredo-Aguilera, J. A. (2022). Impact of physical exercise in advanced-stage cancer patients: Systematic review and meta-analysis. Cancer Medicine, 11(19), 3714–3727. https://doi.org/10.1002/cam4.4746
  6. Albini, A., La Vecchia, C., Magnoni, F., Garrone, O., Morelli, D., Janssens, J. Ph., Maskens, A., Rennert, G., Galimberti, V., & Corso, G. (2025). Physical activity and exercise health benefits: Cancer prevention, interception, and survival. European Journal of Cancer Prevention, 34(1), 24–39. https://doi.org/10.1097/CEJ.0000000000000898
  7. Mustian, K. M., Lin, P.-J., Chakrabarti, A., Mattick, L. J., Samuel, S., Gada, U., Altman, B. J., Vertino, P. M., Kleckner, A. S., Kleckner, I. R., Guido, J. J., Li, C.-S., Peppone, L. J., Kamen, C. S., Loh, K. P., Rousey, S. R., Onitilo, A. A., Melnik, M., Mohile, S. G., & Janelsins, M. C. (2026). Effects of exercise on cognitive impairment in patients receiving chemotherapy: A multicenter phase III randomized controlled trial. Journal of the National Comprehensive Cancer Network, 24(3), 91–99. https://doi.org/10.6004/jnccn.2025.7118
  8. Knols, R., Aaronson, N. K., Uebelhart, D., Fransen, J., & Aufdemkampe, G. (2005). Physical exercise in cancer patients during and after medical treatment: A systematic review of randomized and controlled clinical trials. Journal of Clinical Oncology, 23(16), 3830–3842. https://doi.org/10.1200/JCO.2005.02.148
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  10. Sprod, L. K., Mohile, S. G., Demark-Wahnefried, W., Janelsins, M. C., Peppone, L. J., Morrow, G. R., Lord, R., Gross, H., & Mustian, K. M. (2012). Exercise and cancer treatment symptoms in 408 newly diagnosed older cancer patients. Journal of Geriatric Oncology, 3(2), 90–97. https://doi.org/10.1016/j.jgo.2012.01.002
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Two AstraZeneca Drugs To Be Scrutinized in First FDA Cancer Advisory Panel in 9 Months

Tristan Manalac, BioSpace, March 9, 2026


The FDA’s cancer advisors will discuss AstraZeneca’s application for the oral SERD camizestrant in breast cancer and the AKT inhibitor Truqap in prostate cancer.

The FDA’s Oncologic Drugs Advisory Committee will meet at the end of April to discuss two of AstraZeneca’s cancer drug applications—one seeking approval in breast cancer and another requesting a label expansion in prostate cancer.

The panel of outside experts is scheduled to convene on April 30, according to a Federal Registry posting, breaking what will be more than nine months of silence for the Committee. The ODAC, as the board is more commonly known, last met in July 2025.

The April meeting will be a whole-day affair, according to the registry notice. The morning session will focus on AstraZeneca’s new drug application for the oral SERD drug camizestrant, in combination with a CDK4/6 blocker such as Pfizer’s Ibrance or Novartis’ Kisqali, for HR-positive, HER2-negative breast cancer in the first-line setting.

[….]

Despite acing its target outcomes, analysts at Leerink Partners expressed concerns about how SERENA-6 was designed. “Importantly, the trial does not answer if intervening earlier, leveraging serial diagnostics to detect the early emergence of [ESR1 mutations], provides a longer-term benefit to patients rather than front-loading a benefit that could have eventually occurred in a later line,” they wrote in a note to investors on Friday.

In addition, while oral SERDs have become the standard of care for second-line therapy in ESR1m breast cancer patients, SERENA-6 “did not have an oral SERD widely used in the 2L and crossover to [camizestrant] was not permitted.”

[….]

During the afternoon session on April 30, the FDA’s cancer committee will discuss AstraZeneca’s bid to expand its AKT inhibitor Truqap to treat metastatic hormone-sensitive prostate cancer. Data from the Phase 3 CAPItello-281 trial showed that the drug plus abiraterone significantly improved radiographic progression-free survival versus placebo plus abiraterone.

The Phase 3 CAPItello-280 study of Truqap was halted in April 2025, however, as an independent data monitoring committee concluded that a combination regimen of the drug with docetaxel and androgen-deprivation therapy would miss its primary endpoints of overall survival and progression-free survival in patients with metastatic castration-resistant prostate cancer.

The ODAC meeting in April comes amid mounting criticism of FDA panels, which according to experts, have grown increasingly unbalanced and devoid of nuance.

In a September 2025 interview with BioSpace, for instance, Diana Zuckerman, president of the nonprofit National Center for Health Research, blasted a July 2025 expert panel on the use of selective serotonin reuptake inhibitors in pregnancy, which she said put too much emphasis on the potential harms of these drugs and not enough on their benefits.

“They didn’t want any nuance. It seemed they didn’t want any real difference of opinion,” she said.

To read the entire article, click here Two AstraZeneca Drugs To Be Scrutinized in First FDA Cancer Advisory Panel in 9 Months – BioSpace

Prasad Out At FDA, Turning Critics’ Focus Back To Makary


FDA’s polarizing and high-profile biologics chief Vinay Prasad is leaving the agency for the second time since his tenure began a year ago, and this time his departure may be permanent, after yet another controversy over rare disease approvals spilled into public view and cast new doubts on Prasad and Commissioner Marty Makary’s leadership. Makary’s next pick to run the biologics center is viewed as a make-or-break decision for his commissionership.

A House Energy & Commerce Committee Democrat who is vocal on FDA issues told Inside Health Policy the next goal for the agency’s critics could be ousting the commissioner. “Prasad is Makary’s man and Makary’s failure. Makary’s seat is hot and now we need a hearing to make it hotter,” Rep. Jake Auchincloss (MA) said.

In a social media post, Makary spun the departure as a planned return to Prasad’s family and academic committees after a one-year leave of absence from the University of California San Francisco, saying he has accomplished lasting reforms at the agency. Prasad had not previously mentioned plans to spend only a year at FDA.

The latest controversy for the Center for Biologics Evaluation and Research was its decision not to approve a Huntington’s disease gene therapy from UniQure, followed by anonymous statements from FDA officials to the media that left industry fuming. But that was one in a string of rare disease decisions under Prasad that angered industry and other FDA stakeholders. He also made several decisions on vaccines that were unpopular with regulated industry and public health stakeholders, including refusing to review Moderna’s mRNA influenza vaccine. He made headlines for claiming FDA had linked COVID-19 vaccines to multiple pediatric deaths, then never publicized promised data.

[….]

Many members of Congress have already criticized the agency under Makary’s leadership for what they see as inconsistent or inappropriate demands placed on rare disease drugmakers. Auchincloss said at an event earlier this week that Makary and Prasad should both be fired.

The dispute with UniQure centers around FDA asking the company to do a follow-up trial of its gene therapy that would require placebo surgery. FDA officials say the surgery isn’t risky or invasive; but UniQure and many Huntington’s disease patient advocates say it is. The anonymous FDA official said on the call with press UniQure’s original trial offered a “distorted or manipulated comparison,” and an HHS spokesperson told the Washington Post UniQure “lied” about what FDA wants from a second trial.

[….]

The dispute was viewed as not boding well for Prasad’s leadership at the biologics center. He had already left FDA for a short period once, amid controversy over a different gene therapy, before rejoining the agency. Another Makary appointee, George Tidmarsh, was accused of using his position to pursue a “bizarre personal vendetta” against a regulated company and left the agency permanently.

The backlash to the UniQure situation from rare disease stakeholders also isn’t a good sign for buy-in to FDA’s plausible mechanism pathway, which Makary has touted as evidence of a flexible regulatory flexibility but appears to offer more flexibility in theory than the agency is offering in practice.

Diana Zuckerman, president of the National Center for Health Research, told IHP Prasad’s departure from CBER represents a setback for efforts to strengthen scientific rigor in the agency’s regulatory decisions. She said Prasad brought a focus on scientific evidence that many researchers and policy experts have long argued has been missing at senior levels of FDA.

Zuckerman said that across several administrations, the agency has increasingly emphasized “customer service,” with industry too often treated as the primary customer rather than patients and public health. While she acknowledged that Prasad’s decisions and outspoken criticism of the agency drew opposition from industry groups, some rare disease advocates and even FDA staff, she said independent researchers have repeatedly raised concerns that FDA has approved costly medical products that are ineffective or unsafe.

In her view, the agency’s reliance on more “flexible” approval standards for products that lack clear evidence of benefit is contributing to rising health care costs and straining federal programs such as Medicare and Medicaid. “I think Dr. Prasad leaving is a loss for the FDA, for patients, and for Medicare and Medicaid,” Zuckerman said. 

To read the entire article, click here: https://insidehealthpolicy.com/inside-drug-pricing-daily-news/prasad-out-fda-turning-critics-focus-back-makary