All posts by CPTFeditor

US Device Industry and FDA “Colluded” on Legislation to Weaken Regulatory Oversight

In the News, New Cancer Research
Jeanne Lenzer, THE BMJ: December 17, 2015

US Food and Drug Administration officials had multiple meetings with leaders of the medical device industry to craft legislation that critics say will severely weaken regulatory oversight of the industry, an investigation by the online news service Inside Health Policy has found.

The revelations, discovered in emails and documents obtained under the Freedom of Information Act, have led to renewed calls by professional and public interest watchdog groups to defeat companion legislation to the proposed 21st Century Cures Act, which has been referred to the Senate. They have also called to oppose the approval of Robert Califf as a nominee for the role of FDA commissioner because he took part in meetings with the Advanced Medical Technology Association (AdvaMed), a trade association for medical technology companies.

[…]

Michael Carome, director of the health research group at Public Citizen, a public interest organization, described as “unseemly and inappropriate” the meetings between the FDA and the device industry to craft the language in the act.

Carome said that Califf’s “participation in this collusion with industry” should, at a minimum, put Califf’s nomination as FDA commissioner on hold pending an investigation. Carome said, “The attitudes [Califf] has developed over his decades long history of extensive financial ties to pharmaceutical and medical device companies leave him all too willing to promote the interests of regulated industries over those of public health and patient safety.”

The National Physicians Alliance, together with Public Citizen and six other organizations, wrote a letter to the House of Representatives on 19 May, stating that the 21st Century Cures Act “fails to ensure a . . . scientifically based approach” to drug and device approval and that it will allow “unsafe and ineffective drugs and medical devices to enter the market.”

[…]

The FDA defended its meetings with the industry, telling The BMJ that “FDA officials routinely meet with a diverse group of stakeholders.” The agency said that it had met with 12 representatives of public interest and professional organizations who attended a meeting on 28 October, after the bill was referred to the Senate in July.

Diana Zuckerman, president of the National Center for Health Research, whose organization requested the October meeting, told The BMJ that none of the more than two dozen non-profit organizations that are members of the Patient, Consumer, and Public Health Coalition had been invited by the FDA to help develop any provisions of the 21st Century Cures Act or its Senate companion bill.

She said, “There’s a world of difference between talking about approval standards in general and crafting specific legislative language. It is outrageous that FDA officials and regulated industry are sitting down to craft legislative language to give to congressional staff.”

[…]

BMJ 2015; 351 Cite this as: BMJ 2015;351:h6820

To read the full article, click here.

Palliative Care and Pain Management for Lung Cancer and Other Serious Illness

Lung Cancer
Jessica Becker, Brandel France de Bravo, MPH, and Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund

Palliative care is often misunderstood as meaning a patient will not get “real treatment.”  That is not accurate.  In fact, patients who have palliative care often live longer as well as having a better quality of life.

A ground-breaking study published in the highly respected New England Journal of Medicine shows that palliative care, which helps manage symptoms and control pain, is a very effective addition to standard cancer treatment for people with metastatic non-small-cell lung cancer.[1] The patients who had palliative care, which was offered as soon as they were diagnosed, suffered less depression, were less likely to receive aggressive end-of-life care, and lived longer.

Non-small-cell lung cancer is the most common form of lung cancer, and metastatic lung cancer means that the cancer was caught very late (Stage 4) and has spread beyond the lungs and lymph nodes to other organs like the brain, bones, or heart. When lung cancer spreads like this, it is inoperable and incurable. Various treatments have been found to prolong life by months and in some cases years, but these treatments have many unpleasant/serious side effects, involve hours of chemotherapy or radiation treatment on a regular basis, and do not necessarily provide relief from the many debilitating and painful symptoms of late-stage lung cancer.

A different study, published in a medical journal in 2014 focused on patients with various serious diseases who were having trouble breathing.  Half the patients received “breathlessness support services” for 6 weeks and the other half did not.   The support services included palliative care, respiratory medicine, physiotherapy, and occupational therapy.  Six months later, the patients who had received the support services had less trouble breathing and were more likely to still be alive.  The services helped all patients breathe more easily but only improved survival for patients with COPD or non-cancerous lung disease, not for patients with cancer. [2]

A third study, which analyzed 16 studies of palliative care found that patients who had at least one consultation for palliative care spent an average of 4.4 fewer days in the intensive care unit. [3]

What Is Palliative Care?

Palliative care focuses on helping relieve the patient’s pain, offering psychological support to the patient and family, and providing the patient and family with information they may need to adapt to life with a serious illness and make relevant decisions. This kind of care enables patients with late-stage cancer and other debilitating diseases to live as comfortably as possible during the time they have left and spend meaningful time with their families.

Some people mistakenly equated end-of-life palliative care with ending people’s lives through so-called “death panels.”  However, this new research is an example of how palliative care can improve the quality of life and even prolong life for patients who are very ill.

Many doctors do not feel comfortable discussing end-of-life issues or advance care planning.  However, now that palliative care is often reimbursed by Medicare or private insurance, patients are more likely to consider it.

Patients Should Not Have to Choose Between Comfort and Treatment

The study of lung cancer patients published in the New England Journal of Medicine deserves special attention because of its implications for many patients with fatal diseases.

The study patients did not have to choose between cancer treatment and palliative care. Half of the 151 patients with non-small-cell lung cancer at Massachusetts General Hospital were randomly assigned to get cancer treatment and the other half were given palliative care in addition to cancer treatment. The patients that were assigned to receive cancer treatment and palliative care reported a better quality of life (measured by patient’s scores on three different quality-of-life gauges) while patients receiving cancer treatment alone experienced a decrease in their quality of life.

The patients who were offered palliative care plus cancer treatment had fewer symptoms of depression. Only 16% showed symptoms of depression while 38% of patients getting only standard cancer treatment had symptoms of depression.

More patients in the group assigned only to standard cancer treatments received aggressive end-of-life care, including chemotherapy, compared to patients who received palliative care plus cancer treatment.  Aggressive end-of-life care was defined as chemotherapy during the last two weeks of life; no hospice care; or hospice care for only the last few days of life. Hospice care is a form of palliative care for those who are terminally ill and near death, and can be provided at home or in a hospice. Aggressive end-of-life care can be very expensive. Even when health insurance covers a significant portion of the medical expenses, it can be very costly for a patient and the patient’s family.

Although the patients receiving palliative care plus standard treatment were less likely to continue with aggressive treatment, they lived about 2 months longer than the patients receiving only standard cancer treatment alone. In addition to showing that patients live longer and better when given palliative care, the study suggests that treatment that helps the whole patient and doesn’t just focus on fighting the cancer may also be more cost-effective.

The researchers explain their findings in several ways:

  • The improvements in quality of life, such as fewer symptoms of depression, may have helped patients live longer;
  • By pursuing less aggressive treatment, the patients enrolled in palliative care may have benefited from fewer toxic side effects which may have increased their will to live;
  • Palliative care patients got earlier referral to hospice programs, and preparing for death in a supportive environment may have helped prolong life.

While this specific study only focused on the use of palliative care in conjunction with standard cancer treatment for patients with metastatic non-small-cell lung cancer, the two other studies described in this article show that patients with other kinds of metastatic cancer or other terminal diseases might also benefit from palliative care plus standard treatment. This deserves further study.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References

  1. Temel J, Greer J, Muzikansky A, Gallagher E, Admane S, Jackson V, Dahlin C, Blinderman C, Jacobsen J, Pirl W, Billings J, Lynch T: Early Palliative Care for Patients with Metastatic Non-Small-Cell Lung Caner. New England Journal of Medicine 2010; 363:733-742.
  2. Higginson IJ,  Bausewein C, Reilly CC, Gao W, Gysels M, Dzingina M,  McCrone P, Booth S,  Jolley CJ, Moxham J: An integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness: a randomised controlled trial. Lancet Respiratory Medicine Journal 2014. 979-87. http://www.ncbi.nlm.nih.gov/pubmed/25465642?dopt=Abstract
  3. J. Brian Cassel, Kathleen Kerr, Steven Pantilat, Thomas Smith,  Donna McClish: Does Palliative Care Consultation Reduce ICU Length of Stay? Journal of Pain and Symptom Management 2011. 41, 191-192. http://www.jpsmjournal.com/article/S0885-3924%2810%2900752-9/fulltext

Senate Committee Approves Legislation to Speed Approval of Medical Devices

In the News, News Stories & Editorials
Thomas M. Burton, The Wall Street Journal: March 9, 2016

WASHINGTON—A Senate committee Wednesday approved a slate of bills that would relax requirements for approval of medical devices by the Food and Drug Administration, part of a larger effort aimed at speeding up the regulatory process and boosting medical research.

Most of the measures were approved with bipartisan support, but there are indications of discord on the package. Some patient-safety advocates said the legislation would weaken the FDA’s ability to ensure the dependability and safety of medical devices.

[…]

At issue is how aggressively the FDA will regulate medical products. The “breakthrough” [products] bill, for example, would allow the use of shorter or smaller clinical studies and quicker measures of success, and medical-device safety experts have already expressed concern that the standards for device approval are significantly lower than those for drugs.

[…]

The “breakthrough” bill “sets a low bar to qualify for ‘breakthrough’ status’ ” and “lowers standards for safety and effectiveness,” said Diana Zuckerman, president of the National Center for Health Research in Washington, a medical research and advocacy group.

[…]

“We are concerned that the focus of these bills is on getting medical products to market more quickly, instead of making sure that they are safe and effective,” Dr. Zuckerman wrote on behalf of her group and 13 other medical safety groups in a letter to the senators on the HELP committee.

To read the full article, click here.

Phrma: Easing Speech Limits Could Reduce Need for Subgroups in Trials

In the News
Joe Williams, Insidehealthpolicy.Com: March 7, 2016

As FDA faces pressure from consumer groups to mandate demographic subgroup participation in trials, the pharmaceutical industry argues a better solution is to let industry communicate real-world information about the safety and effectiveness of marketed products.

Attendees at a recent FDA public meeting on the implementation of a federal action plan to encourage greater use of demographic subgroup data in new drug and device applications urged the agency to mandate inclusion of specific populations in clinical trials as a contingency of approval.

A representative for the pharmaceutical lobby, however, said that such a requirement would prolong clinical trials, and instead said allowing drug companies to share truthful, non-misleading information that does not impact the risk-benefit profile of approved medications would allow industry to communicate data on safety and effectiveness in subgroups in the postapproval space.

[…]

Ulrich said it was necessary to balance getting the perfect answer with the need to provide medicines to those patients who need them.

Drug and device approvals over the past few years show a lack of representation by key subgroups in clinical trials. Tracy Rupp of the National Center for Health Research said that of the 15 premarket approval devices reviewed by advisory committees in 2014, 60 percent did not include at least 30 African Americans, three had less than 10 and some had zero represented. In the same year, Rupp said one-third did not specify whether any individuals 65 years of age or older participated.

“Most devices that would be used by both men and women did not include subgroup analysis to determine if the device was safe and effective for both sexes,” she said.

[…]

Better communication to inform potential clinical trial participants about the possible benefits to their own health, broader sharing of results and improved compensation were other strategies attendees said could encourage more subgroup involvement in studies.

To see original article, click here. 

Remedy for a Sick Industry

In the News, News Stories & Editorials
Peter Korn, Portland Tribune: March 3, 2016

If he were playing it safe, Dr. Vinay Prasad might be among the last to turn into a medical provocateur.

Prasad works at Oregon Health & Science University’s Knight Cancer Institute as a cancer physician, and OHSU has gone all-in trying to make it a flagship department.

[…]

Prasad’s outspokenness and willingness to criticize industrywide assumptions place him in the ranks of a small but influential group of physicians and researchers who are either having an impact on the way medicine is practiced in the United States, or tilting at windmills. That depends on whom you ask.

Prasad’s voice is starting to get noticed on a national stage, says Diana Zuckerman, president of the Washington, D.C.-based National Center for Health Research. When Prasad published a study last year showing new cancer drugs were no more effective than cheaper drugs already on the market, Zuckerman had the work distributed to members of Congress, the White House and science reporters around the country.

“To me, that’s huge news,” Zuckerman says of Prasad’s findings. “Why wasn’t that in every media outlet in the country? Why wasn’t it on every TV news program?”

Zuckerman says she knows why: “It’s not funded by the (pharmaceutical) industry.”

She calls Prasad an iconoclast, and says the work he and others perform detailing conflicts of interest is more important than ever, because there is more money involved today and more lives affected when bad drugs are put into the marketplace.

“It’s one thing when there’s only one cancer drug and it’s not very good, but maybe it’s better than nothing,” Zuckerman says. “But it’s another thing when there are 10 different cancer drugs for the same type of cancer and eight of them have exaggerated their effectiveness in the research, and the two that are perhaps the best are the oldest generic drugs that nobody is advertising or promoting because they don’t cost much.”

[…]

Many of the treatments Prasad assails turn out to have unintended consequences. Ironically, it is just such an impact that has him worried about his own advocacy work, something he calls “the third harm.”

If people lose trust in the medical system, he says, science suffers. He’s aware that fewer than 10 percent of adult cancer patients enroll in clinical trials designed to reveal the best therapies. Still, third harm or not, he says he has to speak out.

Zuckerman agrees.

“It’s hugely important that they’re doing this,” she says. “If they weren’t, nobody would have any idea of what’s going on.”

Read the full article here.

Patient, Consumer, and Public Health Coalition Senate Briefing: Innovation for Healthier Americans

Policy, Testimony & Briefings
March 4, 2016

Below are the materials from the Senate briefing we hosted with the Patient, Consumer, and Public Health Coalition titled “Innovation for Healthier Americans: The Impact of Proposed Health Bills on Patients & Consumers”.

Lab-Developed Tests (LDTs): A Critical Role for the FDA

Examples that illustrate the need for FDA regulation of LDTs

FDA and Medical Software

Lab-Developed Tests (LDTs): A Critical Role for the FDA

Laboratory developed tests (LDTs) serve an increasingly important role in health care today. Compared to just a few decades ago, the tests are more complex, and inaccurate results are much more likely to endanger patients. When the FDA was given the responsibility to regulate medical devices in 1976, LDTs were basic laboratory tests, such as a blood sugar test. For that reason, the FDA chose not to regulate most LDTs. But today’s diagnostic tests are more complicated and, for example, may be used to obtain a genetic analysis of a cancer cell to guide treatment decisions. FDA regulation of LDTs will ensure patients and physicians are relying on tests that are safe and effective.

CLIA Cannot Substitute for FDA Assurance of Safety and Effectiveness

The CMS CLIA program does not determine if a test is accurate (which is called clinical validity). It instead ensures quality control mechanisms are in place. In contrast, the FDA review process evaluates the clinical validity of a test before it is approved (premarket) and after it is on the market (post-market surveillance). Clinical validity is essential to understanding the risks and benefits of any test. For example, an ovarian cancer test with a high rate of false positives will result in women receiving unnecessary hysterectomies, whereas a high rate of false negatives will result in cancer going undetected.

Transparency Will Increase Physician and Patient Confidence in LDTs and Encourage Innovation

Faulty tests erode the confidence of physicians and patients, and put patients’ lives at risk. The American Society of Clinical Oncologists (ASCO) has expressed agreement with the FDA’s proposals to improve regulation of LDTs, stating that “a patient’s treatment options are increasingly driven by detection of molecular abnormalities in the tumor that drive treatment selection. ASCO believes that the tests used to detect those abnormalities must be of the highest quality and thoroughly validated before being offered to doctors and patients.” Requiring FDA review prior to allowing a test to be sold and giving FDA the authority to gather and publicly share information about adverse events will give patients and providers the information they need to make informed treatment decisions. Non-LDT in vitro diagnostics (IVDs) are already under FDA regulation. Using the same regulatory processes will ensure higher quality tests for patients. That will stimulate, not hamper, the kind of innovation that saves lives and improves the quality of patients’ lives.

FDA’s Plan Follows a Risk-Based, Phased-In Approach to Ensure Efficiency and Responsiveness

The FDA draft guidance on LDTs lays out a risk-based, phased-in approach that will proceed over several years. This approach allows ample time for laboratories to come into compliance and will also ensure that the highest-risk devices are regulated as quickly as possible. The guidance document also proposes a series of carve-outs, permitting manufacturers of LDTs for unmet needs or rare diseases to escape the most stringent pre-market review requirements. This type of regulatory framework will protect the public health while being flexible enough to encourage the development of new tests for serious conditions.

Conclusions

In response to the FDA’s proposed regulatory framework, NIH Director Dr. Francis Collins stated that “this is good news for all who are working to turn the dream of personalized medicine into a reality.”1 We agree. The FDA’s draft guidance displays the agency’s willingness to balance its goals regarding safety and efficacy with its concerns about innovation and patient access — and all parties should work together to move our regulatory framework for LDTs into the 21st century.

Examples that illustrate the need for FDA regulation of LDTs

OvaSure Ovarian Cancer Test

The OvaSure ovarian cancer test shows the importance of FDA oversight of LDTs in protecting patients’ lives.

  • In June 2008, the test was marketed to screen for early-stage ovarian cancer in high-risk women based on peer-reviewed published data showing it could detect ovarian cancer with a positive predictive value (PPV) of 99.3%.
  • It was later discovered that poor study design led to a falsely high predictive value. The actual PPV was only 6.5%, meaning that only 1 in 15 patients who tested positive actually had ovarian cancer.
  • OvaSure was pulled from the market by October 2008 after a warning letter from the FDA but not before many women underwent unnecessary hysterectomies because of a faulty test.

Oncotype DX HER2 Breast Cancer RT-PCR Test

FDA regulation will help ensure the validity of LDTs that detect genetic tumor markers and guide drug therapy decisions. These LDTs are critical to the success of the Precision Medicine Initiative. Patients and their providers must be able to trust them.

  • The Oncotype DX HER2 breast cancer RT-PCR test was intended to diagnose early stage HER2 receptor positive breast cancers so that the appropriate HER2 targeted drug could be used.
  • In 2011, a group of prominent pathologists from three independent laboratories found discrepancies between this HER2 RT-PCR and other tests that are FDA-approved. They discovered that the test has poor sensitivity, resulting in many false negatives and women not receiving life-saving treatment. Patients died as a result.

FDA and Medical Software

Jay G. Ronquillo, MD, MPH, MMSc, MEng

In a study of FDA reported recalls, completed in 2016, we found:

  • Over the last 5 years, more than 600 different software devices totaling over 1.4 million units were recalled for moderate or high risk patient safety issues.
  • Nearly 200,000 units were recalled for having the most serious (life-threatening) risk to patients. Although recalls are officially considered voluntary, few would take place without FDA regulatory authority.

If MEDTECH becomes law, the FDA would not be gathering adverse event reports and encouraging recalls of many stand-alone IT devices with life-threatening flaws. The results of this study show that software flaws affect millions of patients and removing medical software from FDA regulatory oversight would be dangerous. The Senate can do better.

Medical software represents an increasingly important aspect of medicine. The MEDTECH Act and related bills would remove some health IT entirely from FDA’s regulatory oversight (e.g. electronic health records, clinical decision support). For other types of software, the FDA would be limited in its ability to identify safety risks. Industry says that deregulation would foster the creation of innovative new medical devices. However, the data above indicate that medical software must remain regulated by the FDA in order to protect patients from harm.

Some examples of the devices that were recalled in recent years because of their potential to seriously harm or even kill patients due to software errors include:

  • Oncology electronic medical record systems: recalled because they calculated and recorded incorrect drug dosage treatment.
  • Clinical decision support systems used during surgery: recalled because they erroneously switched patient data and failed to warn physicians about dangerous drug reactions.

Software devices are re-used repeatedly for different patients. A conservative estimate is that millions of patients being treated by hundreds of physicians would have unknowingly been at risk for poor care, serious injury, and even death if the software had not been recalled.

Conclusion: If medical software is removed from FDA regulatory oversight, millions of patients would be at risk from defective software.

Prostate Cancer: Diet and Dietary Supplements

Diet, Habits, & Other Behaviors, Prevention, Prostate Cancer
Brandel France de Bravo, MPH, Caitlin Kennedy, PhD, Anna E. Mazzucco, PhD, and Laura Gottschalk, PhD, Cancer Prevention & Treatment Fund

Prostate cancer is the second most common cancer among American men, and the second leading cause of cancer deaths among them as well. The American Cancer Society estimates almost 192,000 new diagnoses of prostate cancer in 2020, and more than 33,000 prostate cancer related deaths.[1] 

Compared to most cancers, prostate cancer usually progresses very slowly, and many men live with it for years and even decades. Once diagnosed, some men decide to undergo treatment to halt the progression of the disease, and others refrain from treatment, preferring instead to closely monitor the cancer’s progression. Those who choose “active surveillance” do this because the medical and surgical treatments for prostate cancer often cause very undesirable side effects, and because most men with prostate cancer will die from something else. This strategy is especially likely for older men in the earliest stage of the disease.

At one time, it was unheard of to suggest that diet might have a role to play in battling prostate cancer. But there is now evidence that certain foods and dietary supplements have an impact on prostate health—both positive and negative. Some foods or supplements appear to promote prostate health and prevent cancer cells from developing, but others should not necessarily be taken by men who already have prostate cancer.

The role of diet drew researchers’ attention when they noticed that prostate cancer rates vary greatly from one country to another, with the highest rates appearing in countries where people tend to eat a lot of fat. Studies also show that men who are obese or have a high fat diet are more likely to have prostate cancer.[2] Diets high in saturated fats, such as the animal fats found in red meat, may pose the greatest risk. The lowest rates of prostate cancer are found in Asian countries where men eat a lot of soy foods, a rich source of naturally occurring phytoestrogens. It was hoped that by increasing men’s intake of phytoestrogens, they might reduce their risk of prostate cancer, slow its progression, or reduce the risk of prostate cancer recurring, but at least three studies have failed to find any protective benefit from phytoestrogens.[4][5][6]

Dietary Supplements

As more and more people take dietary supplements containing antioxidants, studies have been conducted to determine their effect on reducing the risk and growth of cancers, including prostate cancer. Three antioxidants that have received attention with regard to prostate health are vitamin E, selenium, and vitamin D.

Studies comparing men who live in areas of the country with high levels of selenium to men in areas with low levels suggest that this mineral protects against prostate cancer. Selenium was believed to reduce the risk of developing prostate cancer because it keeps cells from proliferating or dying off in a rapid or unusual way. An analysis in 2002 of the Nutritional Prevention of Cancer Trial revealed that the men who took selenium supplements daily were half as likely to be diagnosed with prostate cancer.[7] However, a 2014 report based on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) indicated that selenium supplements increased the risk of prostate cancer by 91% and taking vitamin E supplements increased the risk of prostate cancer by 17%.[8] This result led the researchers to discourage men over 55 from taking amounts of vitamin E higher than the recommended dietary allowance (RDA), which is 15 mg of alpha-tocopherol.  Moreover, a 2009 study found that higher selenium levels in the blood may worsen prostate cancer in many men who already have the disease.[9] As a result of this trial, the researchers have encouraged men over 55 to limit their intake of selenium to the recommended dietary allowance (RDA) of 55 mcgs.

The SELECT findings on selenium don’t mean that antioxidants have no role to play in preventing cancer or slowing its spread. Some antioxidants may be helpful but some may encourage small cancers to grow larger.  A 2014 study by researchers in the U.K. tested the effect of Pomi-T, a supplement that contains broccoli, pomegranate, green tea, and turmeric on the health of men with prostate cancer. After six months, they found that the men taking Pomi-T had a smaller increase in PSA, a protein that becomes elevated with prostate cancer, as compared to men with prostate cancer who didn’t take Pomi-T. The researchers suggest that the unique blend of polyphenols and antioxidants in the supplement had a beneficial effect on health of these prostate cancer patients.[10]

A study published in 2016 brought yet another antioxidant, vitamin D, into the prostate cancer discussion. Vitamin D is well known for its role in helping build strong bones and teeth, but it may also contribute to the fight against cancer (read more here AND here). The prostate cancer study looked at the levels of vitamin D in men who had their prostates removed due to cancer. They found that men who had the most aggressive forms of prostate cancer had lower levels of vitamin D in their blood compared to men with less aggressive forms of cancer.[11] It is not yet known whether higher levels of vitamin D prevent more aggressive forms of prostate cancer or if aggressive prostate cancer lowers levels of vitamin D. Since it is impossible to know if low levels of vitamin D is a cause or effect of aggressive prostate cancer, and since high levels of vitamin D can be dangerous, more research is needed before experts will know if men diagnosed with prostate cancer should try to take more vitamin D.

Bottom Line: We need studies to determine exactly how diet and dietary supplements can be used to prevent prostate cancer and slow its spread. Meanwhile, men should reduce saturated fats as much as possible. While the jury is still out on phytoestrogens, men may benefit from eating more soy products—especially if they are eating them in place of red meat!

For more on cancer and antioxidants, read here.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

  1. American Cancer Society. Key Statistics for Prostate Cancer. Cancer.org. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html. Updated 2020.
  2. Narita, S., Nara, T., Sato, H., Koizumi, A., Huang, M., Inoue, T., & Habuchi, T. (2019). Research evidence on high-fat diet-induced prostate cancer development and progression. Journal of clinical medicine, 8(5), 597.
  3. Ma R, Chapman K. A systematic review of the effect of diet in prostate cancer prevention and treatment. Journal of Human Nutrition and Dietetics. Vol (22)2009:187-199.
  4. Ganry O. Phytoestrogens and prostate cancer risk. Preventive Medicine. Vol (41) 2005:1-6.
  5. Ward H, Chapelais G, Kuhnle GC, Luben R, Khaw KT, Bingham S. Lack of Prospective Associations between Plasma and Urinary Phytoestrogens and Risk of Prostate or Colorectal Cancer in the European Prospective into Cancer-Norfolk Study. Cancer Epidemiology Biomarkers & Prevention Vol (17) 2008: 2891-2894.5
  6. Bosland MC, Kato I, Zeleniuch-Jacquotte A, Schmoll J, Rueter EE, Melamed J, Kong MX, Macias V, Kajdacsy-Balla A, Lumey LH, Xie H, Gao W, Walden P, Lepor H, Taneja SS, Randolph C, Schlicht MJ, Meserve-Watanabe H, Deaton RJ, & Davies JA. Effect of soy protein isolate supplementation on biochemical recurrence of prostate cancer after radical prostatectomy. JAMA 2013; 310(2): 170-178. doi: 10.1001/jama.2013.7842
  7. Duffield-Lillico AJ, et al. Baseline characteristics and the effect of selenium supplementation on cancer incidence in a randomized clinical trial: A summary report of the Nutritional Prevention of Cancer Trial.Cancer Epidemiology, Biomarkers, and Prevention. Vol (11) 2002: 630-639.
  8. Kristal AR, et al., Baseline Selenium Status and Effects of Selenium and Vitamin E Supplementation on Prostate Cancer Risk.  Journal of the National Cancer Institute, 2014.
  9. Chan JM et al. Plasma Selenium, Manganese Superoxide Dismutase, and Intermediate-or High-Risk Prostate Cancer. Journal of Clinical Oncology. Vol (27) 2009: 3577-3583.
  10. Thomas, R., Williams, M., Sharma, H., Chaudry, A., & Bellamy, P. (2014). A double-blind, placebo-controlled randomised trial evaluating the effect of a polyphenol-rich whole food supplement on PSA progression in men with prostate cancer—the UK NCRN Pomi-T study. Prostate Cancer and Prostatic Diseases, 17(2), 180-186.
  11. Nyame Ya, et al. Associations between serum vitamin D and adverse pathology in men undergoing radical prostatectomy. J Clin Oncol. 2016 Feb 22.

FDA Aims to Speed Clinical Trials, Improve Device Safety Through Post-Market Evaluation, but Funding a Hurdle

In the News, News Stories & Editorials
Joe Williams, Inside Health Policy: February 16, 2016

FDA’s device center chief Jeff Shuren, in an interview with Inside Health Policy, highlighted the benefit a robust National Device Evaluation System could have in bolstering the agency’s ability to monitor devices in real-time to better inform the risk-benefit profile of approved products. Such a system, he said, could also help in the premarket approval phase to reduce the clinical trial burden on manufacturers and get products to market faster.

The program is a high priority for the Center for Devices and Radiological Health within FDA. It was recently listed in CDRH’s 2016-2017 priority agenda, and FDA in the fiscal 2017 budget requested $1.8 million in funding to help establish the system as part of President Barack Obama’s Precision Medicine Initiative. The agency will hold a public workshop in March on the effort.

The goal for FDA, according to Shuren, is to move past the traditional scope of a national surveillance system and launch a program that would allow the agency to more accurately track and analyze the use of medical devices in a real-world setting and better understand the benefits and risks of specific products outside of the clinical trial setting. […]

“I think more money is problem number one and without more money the agency is never going to do a good job,” Diana Zuckerman, president of the National Center for Health Research, told IHP.

Stakeholders have suggested the medical device user fee process is more difficult to navigate than the sister program in the drug center, given the financial disparity in the medical device industry between the large corporations and smaller start-ups. Zuckerman, however, argued that no one is expecting a small device company to pay millions in user fees to cover something like postmarket surveillance.

“There are many small companies and, yes, small companies should have user fees that are affordable, but the medium, large and extra-large sized device companies could be paying a lot more,” she said.

Johnson & Johnson, for example, pays roughly $2.4 million in user fees for a new drug application, sources say, and only $5,000 for a 510(k) submission. A spokesperson for J&J did not respond to inquiries.

Increasing the amount of user fees for the large companies, sources say, could help fund FDA’s postmarket surveillance goals. Sources familiar with the user fee discussions tell IHP, however, that the medical device industry, in particular the Advanced Medical Technology Association, has rejected the notion that industry should have to pay more for faster approvals. […]

 

To read the full article, click here.

Cancer Moonshot Misses the Target

In the News, News Stories & Editorials
Tinker Ready, HealthLeaders Media: February 11, 2016

Hospitals don’t have much to gain from the moonshot, at least in the short run. There are lots of other pressing, fixable problems with cancer care that the Obama administration’s effort won’t address. […]

Let’s assume billions for research are well spent. Everyone is happy when we fund cancer research. Why be a buzz kill? Because, in reality, there are a whole lot of other problems with the way we develop and deliver the treatments we already have.

Prevention and Care Delivery

The Cancer Moonshot might do a lot more to improve the prospects for cancer patients by looking beyond cures and paying attention to problems with cancer care delivery, costs, access and prevention. With hospitals’ fortunes now tied to outcomes and population health, they should be looking for breakthroughs in those areas, not toward another marginally effective $100,000 drug.

Diana Zuckerman is a former Congressional aide and long-time DC-based women’s health advocate. She is one of the founders of the Cancer Prevention and Treatment Fund, a non-profit group that promotes cancer risk reduction and helps patients “in choosing the safest and most effective” treatments.

Zuckerman supports additional research funding. She’s just not sure the moonshot will change much.

“This administration has a year left,” she said “What are they going to accomplish? It takes more than a year. We’ve had so many wars on cancer and we’ve had a lot of progress. But If you want to make meaningful progress, you don’t [just] throw money at a problem for a year.”

Her wish list: Zuckerman would like to see more FDA scrutiny, both before and after approval, of marginally effective cancer drugs. Costs are another issue and one way to keep them down would be to prevent drug makers from charging so much for treatments made possible by publically funded NIH research. Like the moonshot. […]

To read the full article, click here.

 

Breast implants and mammography: what we know and what we don’t know

Breast Cancer, Prevention, Uncategorized, ,
Elizabeth Santoro, RN, MPH and Dr. Diana Zuckerman

There has been a lot of attention given to mammography screening in recent years. Some of this information has been confusing to women—at what age should I first have a mammogram, how frequently should I have repeat mammograms, and are mammograms even effective? These are questions that women both with and without breast implants have been trying to understand. Despite this confusion, the U.S. Preventive Services Task Force recommends screening every two years for women ages 50-74 who have an average risk of breast cancer. Women at high risk because of family history, BRCA gene mutations, or other reasons should discuss a screening schedule with their doctor.  But, what does this mean for women who have breast implants? Are women with breast implants faced with different risks when undergoing a mammography screening? Will women with implants require special considerations during the procedure?

Delayed Breast Cancer Detection

Breast implants can interfere with the detection of breast cancer, because the implants can obscure the mammography image of a tumor. Implants therefore have the potential to delay the diagnosis of breast cancer. Although mammography can be performed in ways that minimize the interference of the implants, as described below, Miglioretti and her colleagues found that even so, 55% of breast tumors were missed, compared to 33% of tumors for women without implants.2  They also found that among newly diagnosed breast cancer patients who did not have any symptoms, the augmented women had larger tumors than those who did not have implants.

What is the impact of this possible delay in diagnosis?  Research findings have been inconsistent, but a 2013 Canadian systematic review of 12 studies found that women with breast cancer who had breast implants are diagnosed with later-stage cancers than women with breast cancer who did not have implants.3

A delay in diagnosis could result in the woman needing more radical surgery or the delay could be fatal.  A 2013 Canadian meta-analysis of five studies found that if women who had breast augmentation later developed breast cancer, they were more likely to die from it than women diagnosed with breast cancer who did not have breast augmentation.3

These studies indicate that for an individual woman, a delay in diagnosis could potentially result in death, and more research is needed to determine how often that happens, and under what circumstances. From a public health perspective, delays in diagnosis could potentially necessitate more radical surgery: a cancer that could have been treated at an earlier stage with breast-sparing treatments, such as lumpectomy, may instead require a mastectomy.4,5

What are the other possible problems that implants can cause regarding mammography?

A study by FDA scientist Dr. S. Lori Brown and colleagues describes problems that were reported to the FDA related to breast implants and mammography screening.6 The authors found 66 adverse events that were reported as either occurring during the mammogram or involving breast implants interfering with the mammogram. Forty-one reports of either silicone or saline breast implants- – almost two out of three reports– pertained to ruptures that were suspected as happening during mammography. The other 25 reports included delayed breast cancer detection, inability to perform the mammogram due to capsular contracture or because of fear that the implant would rupture, and pain/soreness during and after the procedure.

Description of the FDA Study

This study examined data from the Manufacturer and User Facility Device Experience (MAUDE) database. This FDA database collects mandatory or voluntary reports of medical device adverse events from physicians, breast implant manufactures, consumers, and others. The reports were received between June 1992 and October 2002 for events that occurred between June 1972 and June 2002. The mean age of the implant was 14.5 years, and ranged from 2-29 years.

The use of the MAUDE database has limitations. The FDA does not verify the information that is provided. Therefore, the FDA cannot guarantee that the information is accurate and complete. In addition, in some cases, a doctor and a patient could potentially report the same problem.  On the other hand, most problems are not reported even once, since patient and physician reporting is voluntary. It is well-documented that the vast majority of problems arising from medical products are not reported to the FDA. As a result of these shortcomings, these data cannot be used to calculate the number of new adverse events expected for a given number of people in a defined time period.

Key Implications of the Studies on Implants and Mammograms

Potential Implant Rupture

The FDA warns that all implants will eventually break, and research shows that most women who have implants for ten years or longer will have at least one broken implant.7 The risk of breast implant rupture is known to increase as the implant ages. A study by Holmich and colleagues suggested that during the first ten years a woman has implants, most implants do not break, between 11-20 years most will break, and by the time they are more than 20 years almost all have broken.8 Women with implants have been told that mammography is safe for them, but the results of the Brown study suggest that the risk of rupture can be exacerbated by mammography.

Brown and her colleagues also reviewed the published research on implant rupture during mammography and found an additional 17 cases reported in medical journals. According to the American Society of Plastic Surgery, approximately half of the women who get breast implants are in their 20′s or early 30′s,9 which means that the implants are already broken or vulnerable by the time these women are old enough for screening mammograms.

Mammography may therefore increase the risk of a rupture earlier in the typical lifespan of implants, and the squeezing involved in mammography probably increases the risk of leakage in implants that are already ruptured. The potential risk of rupture or leakage needs to be weighed against the benefits of mammography by each individual woman. For women who are concerned about breast cancer, knowledge of mammography problems might discourage women from getting breast implants, or encourage them to have their implants removed and not replaced. Current guidelines encourage women with breast implants to have regular mammograms provided that the technician knows the woman has implants prior to the procedure and that special techniques are utilized.6 In light of this new research, those guidelines need to be reconsidered, especially for women with silicone gel breast implants, where leakage can cause permanent disfigurement and has unknown health risks.

Avoidance of Mammography

The Brown study also found that implants sometimes make it impossible to perform a mammogram. This can happen for two reasons. First, conditions such as capsular contracture, where the scar tissue around the implant tightens and causes the breast to become hard and misshapen, can make it very difficult or even impossible to perform the mammogram.10, 11 The compression of the breast that is required in order to perform the mammogram can be extremely painful if there is capsular contracture, and in some cases the hardness of the breast makes it impossible to compress the breast for the mammogram. Some women avoid getting mammograms because they are afraid of rupture and the latest research indicates that this is a reasonable concern.

Biomaterials testing of breast implants indicates that implants should only break under the most traumatic circumstances, and yet implants break for no apparent reason, as well as under pressure from mammograms.12 It is difficult to know how much risk a mammogram increases the risk of rupture since so little is understood about why implants break and under what circumstances.

What Does this Mean for Women?

Women considering breast implants and women with breast implants need to be informed consumers, and that includes knowing about the problems that arise from having mammograms with breast implants. This is true for all women, but especially breast cancer patients who may use implants on a healthy breast so that it will match the reconstructed breast after a mastectomy. (Detection of cancer in the reconstructed breast is unlikely to be a problem because mammography is not used after a mastectomy. Since breast cancer survivors are at greater risk for breast cancer in the breast that was not removed, compared to women who have not had breast cancer, survivors should have regular mammograms of the surviving breast, and need to know the risks.

Women with breast implants and those considering breast implants need to know that they will have a different mammography experience than women without implants, to try to improve the accuracy. The special techniques used will push the implant back to try to move it out of the way, and extra views will be taken. Even so, as reported earlier in this article, mammograms performed on women with implants will still miss more tumors than is typical of mammograms for women who do not have implants.7, 13 In addition, women with implants should expect that mammography will require more views and take longer, thus costing more and exposing them to increased levels of radiation. Unfortunately, the most common problem, capsular contracture, can make mammography more painful, less accurate, or even impossible to perform. In such cases other, more expensive tests, such as an MRI or ultrasound, may be required.

Women also need to understand that even if breast implants do not cause contracture or other problems, they will still interfere with mammography and mammograms might still cause rupture and leakage.

The bottom line is that women considering breast implants and those who already have them need to be informed about potential problems with mammography so that they can make the decisions that will help them reduce the risk of breast cancer and avoid the problems that arise with implant breakage and leakage.

For more information on breast implants, see www.breastimplantinfo.org.

Related Content:
What you need to know: Breast cancer, suicide, mastectomy, and breast implants
Summary of: Breast Implants, Self-Esteem, Quality of Life, and the Risk of Suicide
2016 Update: When should women start regular mammograms? 40? 50? And how often is “regular”?