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Should I Get the Flu Shot?

Diet, Habits, & Other Behaviors
Lauren Goldbeck, Alex Pew, Arista Jhanjee, and Kousha Mohseni, MS, Cancer Prevention & Treatment Fund

Everyone 6 months or older who has no restrictive health conditions is encouraged by the Centers for Disease Control and Prevention (CDC) to get the vaccine every year.1

Flu season usually starts as early as October and can last all the way until May. The flu usually peaks between December and March. The CDC recommends getting vaccinated by the end of October. Even if you don’t get your vaccine by then, it’s good to get vaccinated anytime during the flu season.

Check if your office, school, or local government is giving free flu vaccines first. If not, don’t worry!  Most (if not all) pharmacies and doctors’ offices have the vaccine available and it is free (no co-pay at all) under nearly every insurance plan. Just call first to make sure the vaccine is available.

Thanks to the Affordable Care Act (Obamacare), health insurance companies have to provide free preventive services like the flu shot.2 However, insurance companies can require you to go to certain places to get the shot. You should check with your insurance company first before getting your shot.

What’s New for 2019-2020?

As parents are getting their kids ready for flu season, they need to decide whether their children (or they themselves) should get a flu shot or a flu vaccine that comes in the form of a nasal spray. This spray, known as FluMist, sprays a live virus up your nose via mist and is an alternative for those who don’t like the idea of a flu shot. The CDC did not recommend FluMist for the 2016-2017 and 2017-2018 seasons because they rated the spray as ineffective during those years. However, flu vaccines are revised every year, and the CDC expects that FluMist will be effective in 2019-2020 for healthy non-pregnant patients between the ages of 2 to 49.1 Similarly, The American Academy of Pediatrics (AAP) guidelines express no preference for the shot or the nasal spray this season.

How Effective Is the Flu Vaccine in 2019-2020?

The most common flu viruses change every year. Since the new seasonal vaccine requires about 6 months to make, scientists change the flu vaccine every year. Vaccines are made with either three or four viral strains.3 This year, all flu vaccines have four strains.  Scientists change the flu vaccine every year to try to make it as effective as possible against the new flu strains that are most common that year, but that can be difficult to predict.4

For this flu season, current evidence shows that the vaccine will reduce your risk of getting the flu by 40 to 60%.5 Although it’s far from perfect, it’s definitely worth getting.

If I Have Cancer or Am a Cancer Survivor, Should I Get the Flu Shot?

Yes, getting a flu shot is recommended for people with cancer and cancer survivors. It is also important for family members and close friends to get the shot as well. People with cancer or a history of cancer can get more severe flu symptoms that can result in hospitalization and serious conditions if they get the flu. In some cases, patients with certain cancers like leukemia, lymphoma, and myeloma as well as patients who have recently been treated with chemotherapy should preemptively take medication to treat the flu if friends and family around them show signs of the virus.6

The most important thing to know is that people with cancer should get the flu shot and not the nasal sprays like FluMist. This is because the shot uses dead or “inactivated” virus while the nasal sprays use live virus. Make sure to ask your physician any questions you have.6

Can the Flu Shot Give Me the Flu?

No, the flu shot can’t give you the flu. The flu shot is made of proteins that come from dead viruses, so you can’t get infected. However, the flu shot can cause soreness, redness, or swelling around the injection site. It can also cause a low-grade fever or body aches.7

Things to Remember for Young Children

  • Children aged 6 months to 8 years who have never received a flu vaccine should get two doses of the vaccine. The two doses should be separated by at least 4 weeks.
  • Children aged 6 months to 8 years who have previously received 2 or more vaccine doses only need one dose this year.

If I’m Over 65, Is There Anything Different for Me?

As we age, the flu can be more dangerous and vaccines are less effective because our immune systems are not as strong. You may have seen a “high-dose flu vaccine” advertised for people over the age of 65. Should you consider it?

The high-dose vaccine has four times as many flu proteins than the usual flu shot, and so it is expected to be more effective. Studies comparing the high-dose and standard-dose vaccines found that those who received the high-dose version (IIV3-HD) were better protected against the flu during the 2012-2013 flu season.8,9 While studies show that the high-dose flu vaccine (Fluzone) might be more protective than the standard flu shot, the CDC is still reviewing data to see how effective Fluzone is in the 2019-2020 flu season.1 And, individuals receiving the high-dose version also had more of the common side-effects from the flu shot, like a low-grade fever and soreness. Since there is no clear evidence that the high-dose vaccine has benefits that outweigh the risks, the CDC doesn’t have a recommendation for getting one vaccine over the other. However, facilities that offer flu shots may administer the high-dose shot without asking patients what they prefer. If you are 65 or older and don’t want the high-dose shot, you should say so when requesting a shot.

What Should I Do If I Have an Egg Allergy?

Flu injection options are very similar for individuals with and without egg allergies.

  • If your only reaction to eating eggs is hives, you can receive any flu vaccine.
  • If you have a severe reaction to eggs, including nausea/vomiting, changes in blood pressure, respiratory issues, and/or any reaction requiring medication or emergency medical attention (ex. anaphylaxis shock)…
    • You can receive any flu vaccine.
    • You should receive the vaccine in a medical setting and under the supervision of a provider who is trained to address allergic reactions.10

Can I Still Get the Flu Even After Getting the Flu Shot?

 Yes, you can still get the flu after getting the flu shot. There are many strains of the flu that could possibly infect you, and the shot doesn’t protect you against all strains. And as we said, it works better on people with stronger immune systems. Even if you do get the flu, it might be less severe if you’ve had the vaccine.

All articles on our website have been approved by Dr. Diana Zuckerman and other senior staff.

References

  1. Grohskopf LA, Sokolow LZ, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2019–20 Influenza Season. MMWR Recomm Rep 2019;68(No. RR-3):1–21. Retrieved from https://www.cdc.gov/mmwr/volumes/68/rr/rr6803a1.htm. Accessed on April 8, 2020.
  2. Will the Affordable Care Act cover my flu shot? U.S. Department of Health and Human Service. Retrieved from https://www.hhs.gov/answers/affordable-care-act/will-the-aca-cover-my-flu-shot/index.html.  Accessed on September 21, 2018.
  3. American Academy of Pediatrics. Recommendations for Prevention and Control of Influenza in Children, 2019-2020. AAP.org. https://www.aap.org/en-us/about-the-aap/aap-press-room/Pages/Recommendations-for-Prevention-and-Control-of-Influenza-in-Children-2019-2020.aspx. September 2, 2019. Accessed April 8, 2020.
  4. Selecting Viruses for the Seasonal Influenza Vaccine. (2018). Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases. Retrieved from https://www.cdc.gov/flu/about/season/vaccine-selection.htm. Accessed on September 21, 2018.
  5. Frequently Asked Influenza (Flu) Questions: 2019-2020 Season. Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/flu/season/faq-flu-season-2019-2020.htm. Accessed on April 8, 2020.
  6. Should People With Cancer Get a Flu Shot? (2020). Retrieved from https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/low-blood-counts/infections/vaccination-during-cancer-treatment.html. Accessed on April 8, 2020.
  7. Key Facts About Seasonal Flu Vaccine. Centers for Disease Control and Prevention. (2019). Retrieved from https://www.cdc.gov/flu/protect/keyfacts.htm. Accessed on April 8, 2020.
  8. Diaz Granadanos, C. A. et al. (2014). Efficacy of high-dose versus standard-dose influenza vaccine in older adults. N Engl J Med. 2014 Aug 14;371(7):635-45. doi: 10.1056/NEJMoa1315727. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/25119609. Accessed on September 21, 2018.
  9. Shay, D., Chillarige, Y., Kelman, J., et al. (2017). Comparative Effectiveness of High-Dose Versus Standard-Dose Influenza Vaccines Among US Medicare Beneficiaries in Preventing Postinfluenza Deaths During 2012-2013 and 2013-2014. The Journal of Infectious Diseases; 215(4): 510-517. Retrieved from https://academic.oup.com/jid/article/3058746. Accessed on September 21, 2018.
  10. Flu Vaccine and People with Egg Allergies (2019). Centers for Disease Control and Prevention,  National Center for Immunization and Respiratory Diseases. Retrieved from https://www.cdc.gov/flu/prevent/egg-allergies.htm. Accessed on April 8, 2020.

NCHR Statement on Right To Try Legislation before the House Energy and Commerce Subcommittee on Health

Legislation, Policy
Diana Zuckerman, PhD, National Center for Health Research: October 3, 2017

Chairman Burgess, Ranking Member Pallone, and distinguished Subcommittee Members:  Thank you for the opportunity to submit hearing testimony for the record.  The National Center for Health Research is a non-profit organization which analyzes medical and scientific data and produces original health-related research to inform patients, the general public, and policymakers.  We advocate for patients and consumers to have access to safe, effective, and affordable drugs and medical devices.  We accept no funding from the pharmaceutical or medical device industries.

We all agree that terminally ill patients should receive the best medical treatment as quickly as possible.  Some terminally ill patients are willing to take big risks to have a chance to live longer.  Unfortunately, many of us know desperate patients whose efforts to “try anything” made their remaining days miserable and left their families even more devastated.  What can and should Congress do to make sure that desperate patients won’t be exploited, or suffer even more painful deaths as a result of legislation?  That is the key question before you today.

It is essential that all Members of Congress understand what the various Right to Try bills would do.  A key issue is to understand what it means to give access to any experimental treatment that has been in at least one clinical trial. The earliest clinical trials (known as Phase I) often don’t include even one patient.  Instead Phase I trials can include “healthy volunteers” that are much less likely to be harmed by an experimental drug or device than a terminally ill patient would.

In addition, these first (Phase I) clinical trials study very small numbers of people, and do not study whether or not a product works.  They are designed to determine the immediate risks on just a few healthy volunteers or patients.  Since so few people are studied, even if a treatment is immediately and painfully fatal to 10% of patients, for example, these first clinical trials probably would not be able to provide that crucial information.

The Right to Try bill introduced by Representatives Griffith and Brat do not even require that a first clinical trial be completed – it can have just started.  In other words, there is no way that a patient could be warned about any terrible risks of those treatments.

The Johnson Right to Try bill (S 204) requires that a Phase I clinical trial be completed.  That is an improvement over the Griffith and Brat bill, but it is important to know that 85% of drugs that successfully complete Phase I clinical trials are later found to be unsafe or ineffective and are therefore never approved by the FDA.  So neither version would help most patients.

In contrast, the FDA’s current expanded Access Program requires at least some evidence that an experimental treatment might possibly be helpful.  That’s not a very restrictive safeguard, but it is helps protect many patients. The FDA routinely utilizes what the agency terms “compassionate waivers” for very ill patients when doctors request them, and FDA grants such requests 99% of the time.

Another important issue for Congress to consider is whether these bills would exploit patients financially. The experimental drugs provided through the current FDA Expanded Access program are provided for free most of the time, or “at cost.”  The same is true for clinical trials.  The Johnson bill also protects patients from financial exploitation by limiting what experimental treatments can cost.  The Griffith and Brat bill allows companies to charge whatever they want to dying patients desperate for access to any experimental drug or device – even one that has absolutely no evidence that it is either safe or effective.  That means that desperate patients could be required to pay exorbitant fees for the “Right to Try” to be treated like guinea pigs.  Many families would feel tremendous guilt if they could not afford to do so.

FDA’s compassionate use program could be improved, and improvements are already underway thanks to the Navigator program that the FDA has recently initiated with the Reagan Udall Foundation.  Other access issues are inherent in the situation where patients want drugs that are not yet being manufactured in large numbers or when the companies are reluctant to provide drugs that they fear will be harmful to patients who are too ill to benefit.  The GAO’s July 2017 report was generally supportive, with a few recommendations for improvement. And, GAO pointed out that most experimental drugs distributed under Expanded Access eventually obtain FDA approval.  In other words, the program is doing what was intended – giving patients earlier (usually free) access to experimental drugs that will eventually be proven safe and effective.

In addition to harming individual patients, making unsafe treatments available for sale harms our entire drug development enterprise, by eliminating the incentive for patients to participate in clinical trials that would help millions of patients in the future.  If HR 1020 was to become law, then it is likely that the richest patients will buy access to experimental treatments and only the middle-class and low-income patients will participate in clinical trials.  Reputable companies would continue to study new drugs and devices in clinical trials, but progress would be slowed because of difficulty attracting enough patients to participate in clinical trials.  Meanwhile, scam artists and fly-by-night companies would be motivated to make as much money as possible on dangerous or worthless experimental drugs for as long as they are available, and HR 1020 and would make it impossible to gather information about how dangerous their products are.

Such problems have long been documented regarding unproven treatments sold at outrageously high prices in Mexico and elsewhere, where some patients have been irreparably harmed or killed because they sought unproven treatments that were marketed dishonestly.  Indeed, tragedies arising from the “right to try” unregulated medical sales of the 19th Century and early 20th Century were the reason FDA was created, to protect patients and consumers.

To improve Right to Try legislation, Congress should:

  1. Ensure that experimental treatments cannot be sold at a profit by companies or medical professionals;
  2. Ensure that all experimental treatments have been proven safe in completed Phase I or Phase II trials conducted on a reasonable number of patients (not healthy volunteers);
  3. All experimental drugs and devices available through RTT should be studied as part of FDA’s regulatory process;
  4. Information about harmful side effects and adverse events should be required to be reported to the FDA by the physicians.

We strongly urge this Committee to reject the Right To Try legislation that is currently under consideration, because it would undermine the successful FDA compassionate waiver program already in place to enable patients to have access to experimental drugs for free or at cost.

Thank you for the opportunity to present our views.

NCHR Comments to CPSC on the Organohalogen Flame Retardant Petition

Legislation, Policy
National Center for Health Research: September 14, 2017

Thank you for the opportunity to speak today. The National Center for Health Research is an independent nonprofit organization that conducts research and scrutinizes research conducted by others. We often compare conflicting scientific and medical conclusions to determine which are more scientifically sound. We do not accept funding from chemical companies and pharmaceutical companies, in order to avoid conflicts of interest.

We have been very impressed with the Consumer Product Safety Commission’s careful review of children’s products that contain numerous phthalates and we urge the Commission to play a similarly important role regarding organohalogen flame retardants.

The EPA website clearly states that organohalogens “are highly persistent, bioaccumulative, and cause adverse effects in humans and wildlife. Because of the widespread use of these organohalogens in household items and consumer products, indoor contamination may be a significant source of human exposure, especially for children. One significant concern with regard to health effects associated with exposure to organohalogens is endocrine disruption.”[1]

All organohalogen flame retardants are semi-volatile organic compounds (SVOCs), and when they are in products that are indoors, OFRs migrate into air, dust, and films on surfaces such as walls and fabrics. They will also get on the skin, and although they can be washed off, OFRs in the air and surfaces will once again find their way onto the skin. The bottom line is that once OFRs are indoors, they will stay indoors and that means humans will be exposed day after day.

We were not involved in the petition, but note that it included footnotes of numerous relevant studies that we found persuasive. However, the scientific evidence is even stronger today, indicating that exposure from indoor sources can occur by:

1. Ingestion of dust containing OFRs,
2. Hand-to- mouth transfer of OFR-containing dust on hands or direct hand contact with a OFR-containing product,
3. Skin exposure from air or from clothing exposed to OFRs from indoor air and dust, and
4. Inhalation of OFRs found in indoor air.

Unfortunately, many children’s products contain OFRs and children are also exposed due to common household products such as sofas, mattresses, pillows, and electronics. For example, Dr Julie Herbstman from Columbia has conducted research indicating that pregnant women and children are exposed in their homes to detectable levels of PBDE as well as their halogenated replacements. She points out that children, infants, and fetuses are more vulnerable to health effects resulting from exposure to a variety of environmental chemicals, including halogenated flame retardants.

I hope you will carefully review her footnoted testimony, which clearly documents that OFRs in products are causing OFRs in air and dust: Concentrations of organohalogen flame retardants in dust are higher the closer the dust is to the OFR products;

  • The presence and number of products are statistically significantly associated with contamination levels of OFRs in air or dust; this means the association has at least a 95% probability of being proven, and did NOT occur by chance;
  • When one removes such a product from a room, the level of OFRs in air and dust decreases, and vice versa;
  • Organohalogen flame retardants are directly emitted from products when products are placed in an experimental chamber and the emissions measured. In an actual indoor environment, such emissions would result in flame retardant chemical contamination of the room’s air and dust.

In conclusion, flame retardants used in upholstered furniture, children’s products, mattresses and casings for electronics contribute significantly to the levels of indoor air and dust contamination, and subsequent to human exposures.

We agree with CPSC staff that there are likely to be variations in the impact of specific OFRs on human health. In the ideal world, it would make sense that each specific OFR proposed for use as flame retardants in consumer goods should undergo a risk assessment to determine whether it is safe to use. I understand the desire to be very precise and to determine whether some OFRs are safer than others, but in the meanwhile, we know as scientists that these exposures can be extremely harmful. If we look at all the scientific evidence on the toxicity of organohalogens, the risks are clear. As the Director of the National Institute of Environmental Health Sciences noted, it is not possible to study all OFRs, but so far all of them that have been studied are known to pose risks to human health, and especially prenatally and to children. We also know that the combination of exposures from these various chemicals can be much greater than is demonstrated in the study of just one OFR. In order to keep our children safe, it is essential to regulate OFRs collectively as a class unless and until there is scientific evidence that one or more particular OFRs is proven to be safe, and then treat that specific OFR differently.

Reference

  1. Kodavanti, P.S. and Curras-Collazo M. C. (2010). Neuroendocrine Actions of Organohalogens: Thyroid Hormones, Arginine Vasopressin, and Neuroplasticity. Retrieved from https://cfpub.epa.gov/si/si_public_record_report.cfm?dirEntryId=225204.

NCHR Testimony at the FDA on Shingles Vaccine, Shingrix

Policy, Testimony & Briefings
Megan Polanin, PhD, National Center for Health Research: September 13, 2017

Thank you for the opportunity to speak today. My name is Dr. Megan Polanin. I am a Senior Fellow at the National Center for Health Research. Our research center analyzes scientific and medical data and provides objective health information to patients, providers, and policymakers. We do not accept funding from industry, so I have no conflicts of interest.

An effective shingles vaccine is important for public health. As patients get older, they are more likely to develop long-term pain, or post-herpetic neuralgia (PHN), as a complication of shingles. This pain can be severe and chronic. There is no cure, and treatments do not reliably relieve pain for all patients. The only way to reduce the risk of developing shingles and PHN is to get vaccinated.

Like any public health strategy, a vaccine’s benefits must outweigh its risks. Based on available research, Shingrix has displayed significant benefits compared with the current shingles vaccine on the market, Zostavax:

1) Shingrix showed much higher levels of vaccine efficacy (e.g. 97% for 50+ and 90% in 70+) ​ than the current shingles vaccine. Zostavax only reduces the occurrence of shingles by about half for patients 60 and older, and its effectiveness declines as patients age.  For patients 80 and older, Zostavax is only 18% effective.

2) Shingrix has displayed efficacy in preventing ​PHN​ in patients 50 years and older by preventing shingles. Zostavax is less effective in preventing PHN because it is less effective at preventing shingles. For people who were vaccinated and still developed shingles, Zostavax helped to reduce the duration of PHN, but not the severity of pain.

3) Shingrix can potentially be administered to vulnerable patients with ​weakened​ immune systems. Zostavax is a live attenuated vaccine, and therefore is not safe for people with weakened immune systems, such as patients who have had radiation or chemotherapy and those with HIV.

Shingrix requires two doses while Zostavax is a one-time injection. However, that is a small price to pay for a much more effective vaccine.

Post-licensure studies are critical as we need long-term data to evaluate Shingrix’s long-term efficacy for patients 50 years and older. This is especially relevant since Zostavax may no longer be effective 8 to 11 years after vaccination. The company’s proposed long-term follow-up studies will help to determine whether Shingrix is able to protect older adults from contracting shingles as they age. It is essential that those studies be completed in a timely matter and that the company provide adequate incentives to patients to stay in the study.

We do have some concerns about risks. Patients treated with Shingrix had a higher rate of common adverse reactions (e.g. 74% vs. 9% for placebo group), such as pain, swelling, and fatigue. In addition, one serious adverse event, supraventricular tachycardia, was reported more frequently for patients vaccinated with Shingrix compared with patients who had not during the 30-day post-vaccination period. We are also concerned about optic ischemic neuropathy, which was reported within 30 days by 2 patients, within 2 months by another patient, and not reported at all in the placebo group. These issues warrant further attention.

For that reason, we agree with the company and FDA reviewers that continued pharmacovigilance is critical to evaluate adverse events for patients vaccinated with Shingrix compared to those vaccinated with Zostavax and those with placebo. This should include uncommon adverse events observed soon after vaccination and any other adverse events that may arise with larger sample sizes in longer-term studies.

We concur with the FDA’s requests that the company specifically address risks of inflammation from the vaccine, which can lead to the some of the adverse events reported during pre-licensure studies (e.g. optic ischemic neuropathy, gout).

We urge this Advisory Committee to recommend that the FDA require critical post-approval long-term studies to further evaluate the efficacy and safety of Shingrix. We also strongly recommend that the company conduct subgroup analyses to ensure that the vaccine is safe and effective for both women and men and also people of color.

Thank you for the opportunity to share our perspective.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 11-0, that the available data are adequate to support the efficacy and safety of Shingrix when administered to adults 50 years of age and older. 

Streamlined FDA Reviews Fail to Catch Dangerous Glitches in Health Software, Study Finds

In the News, News Stories & Editorials
Casey Ross, STAT News: September 12, 2017

The Food and Drug Administration carefully polices many categories of drugs and devices. But when it comes to software, the agency’s oversight is scanty at best — something that a new study finds is resulting in failure to detect dangerous glitches in software-enabled medical equipment.

The study comes amid ongoing debate over the FDA’s role in reviewing the booming number of software-enabled products in health care.

The study, published in Milbank Quarterly, found that 11 of the 12 software devices subjected to the highest-risk recalls between 2011 and 2015 went through a streamlined review process, known as 501(k), that didn’t require testing for safety and efficacy. The other one was completely exempted from review.

Those recalls included life-sustaining equipment such as ventilators and infusion pumps, as well as a clinical decision support software used to flag adverse drug events during surgery.

“The FDA is allowing many of these products on the market with relatively loose criteria of what is acceptable, and those are the ones that are most likely to end up causing harm,” said Diana Zuckerman, a co-author of the study and president of the National Center for Health Research.

In a response to STAT questions, a spokeswoman for the FDA acknowledged that its review process needs to be updated to reflect issues posed by software-enabled devices.

“FDA’s traditional approach to medical devices is not well-suited to these products,” the spokeswoman, Stephanie Caccomo, wrote in an emailed statement. “A new pragmatic approach must recognize the unique characteristics of digital health technology and the marketplace for these tools, so we can continue to promote innovation of high-quality, safe, and effective digital health devices.” […]

Errors and Glitches

The study examined 627 software devices recalled over the five-year period between 2011 and 2015. Most of the recalled devices (592) were classified as presenting moderate risk; 23 were classified as low risk; and 12 were deemed high risk.

The high-risk recalls involved equipment used in several different settings. Six of the devices were used in anesthesiology, including five ventilators and one decision support tool. The study reported that the software glitches in the ventilators could cause them to stop working prematurely. The decision support tool, used to flag adverse drug events in surgery, could lead to the use of the wrong patient’s data during a procedure. […]

The Impact of Cures Act

The debate over the FDA’s scrutiny of medical software and digital health products is also being played out through implementation of the 21st Century Cures Act, which includes a provision that exempts certain software devices from the agency’s jurisdiction. Zuckerman said the exemption is a step in the wrong direction at the worst possible time, when rapid innovation is producing increasingly complex devices that require deeper scrutiny.

“Our Congress should not have passed a law lowering standards in a way that could be so harmful to patients,” she said. […]

Read the original article here.

Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health

In the News, New Cancer Research
Jay G. Ronquillo and Diana M. Zuckerman, Milbank Quarterly: September 12, 2017

Policy Points:

  • Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial.
  • No studies of medical devices and software assess the impact on patient safety of the FDA’s current regulatory safeguards and new legislative changes to those standards.
  • Our analysis indicates that current regulations are necessary but not sufficient for ensuring patient safety
  • New laws will reduce safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients.

Context: Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. To understand which policies might best protect patients, we examined the impact of the US Food and Drug Administration’s (FDA’s) regulatory safeguards on software-related technologies in recent years and the implications for newly passed legislative changes in regulatory policy.

Methods: Using FDA databases, we identified all medical devices that were recalled from 2011 through 2015 primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall of electronic medical records to determine the manufacturer, device classification, submission type, number of units, and product details.

Findings: A total of 627 software devices (1.4 million units) were subject to recalls, with 12 of these devices (190,596 units) subject to the highest-risk recalls. Eleven of the devices recalled as high risk had entered the market through the FDA review process that does not require evidence of safety or effectiveness, and one device was completely exempt from regulatory review. The largest high-risk recall categories were anesthesiology and general hospital, with one each in cardiovascular and neurology. Five electronic medical record systems (9,347 units) were recalled for software defects classified as posing a moderate risk to patient safety.

Conclusions: Software problems in medical devices are not rare and have the potential to negatively influence medical care. Premarket regulation has not captured all the software issues that could harm patients, evidenced by the potentially large number of patients exposed to software products later subject to high-risk and moderate-risk recalls. Provisions of the 21st Century Cures Act that became law in late 2016 will reduce safeguards further. Absent stronger regulations and implementation to create robust risk assessment and adverse event reporting, physicians and their patients are likely to be at risk from medical errors caused by software-related problems in medical devices.

Read at: https://www.milbank.org/quarterly/articles/software-related-recalls-health-information-technology-medical-devices-implications-fda-regulation-digital-health/

Statement of Dr. Diana Zuckerman in Honor of Dr. Vivian Pinn

In the News, Press Releases
September 8, 2017

I am going to Charlottesville on September 13 to honor Dr. Vivian Pinn, our 2013 Foremother Awards honoree, as a major research facility at UVA’s School of Medicine is named in her honor.  Dr. Pinn received her medical degree from the University of Virginia in 1967, where she was the only woman and only African American in her graduating class. In 2005, she returned to UVA as the University’s first African-American woman commencement speaker, and UVA’s School of Medicine named one of its 4 student advisory colleges as the “Pinn College” in her honor. UVA’s School of Medicine honored her by establishing the “Vivian W. Pinn Distinguished Lecture Series in Health Disparities.”  And now she is the first African American to have a building named in her honor at UVA’s School of Medicine.

We honored Dr. Pinn with our Foremother Award in 2013.  As the first director of the National Institute of Health’s Office of Research on Women’s Health, Dr. Pinn has had many accomplishments.  But one of her most important was her support for the Women’s Health Initiative, which was the first study to determine that women’s  hormones do not need to be “replaced” after menopause, because combined hormone therapy actually increased the risk of heart attack, stroke, and breast cancer in postmenopausal women.  This study resulted in a drop in breast cancer among women for the first time, and has saved thousands of lives.


L to R: Former NIH Director Dr. Bernadine Healy, actor Pierce Brosnan, and
Dr. Vivian Pinn at a Congressional Briefing on Women’s Health Research in 1992.

Will Controversial Bill Cure or Kill Patients?

In the News, News Stories & Editorials
Celia Wexler, Who What Why: September 7, 2017

In 2016, 10-year-old Joshua Hardy lost his long battle with cancer, in part because of a viral infection that resulted from a bone marrow transplant. Hardy’s family tried to get access to a new experimental antiviral drug from Chimerix, the company developing it. The company refused, not wanting to divert time and resources from its efforts to gain FDA approval for the drug. It agreed to make the drug available only after a social media campaign.

Hardy responded well to the drug, but it was too late.

Hardy’s story is one of those featured in the lobbying campaign for a federal Right to Try (RTT) bill, which passed the Senate in August and may soon get a vote in the House.

But the Senate-passed bill would not require drug companies to provide dying patients access to their experimental drugs. Instead, it largely goes after the Food and Drug Administration, and would remove FDA oversight from the process, while insulating the pharmaceutical industry and doctors from virtually any liability if patients are harmed.

RTT pits some desperate patients, along with libertarians and conservative and anti-regulation Republicans, including President Donald Trump and Vice President Mike Pence, against public health advocates, medical ethicists, and some national patient-advocacy groups.

The bill’s supporters frame the legislation as striking a blow for the rights of patients to try any drug without government interference. They predict that more pharmaceutical companies would give patients access to their unproven drugs if they weren’t worried about the FDA looking over their shoulders.

The bill’s opponents contend that any possible expansion of access comes at the cost of eliminating crucial protections for the most vulnerable patients, potentially hastening their deaths and making their end more painful.

Opponents are circulating a letter to the House this week charging that RTT should actually be called the “False Hope” bill. Indeed, given the philosophical bent of its strongest supporters, and their connection to free-market crusaders Charles and David Koch, RTT may be more about advancing a conservative, anti-government ideology than helping the terminally ill. […]

Diana Zuckerman, president of the National Center for Health Research, points out that drug companies rely on a three-phase clinical trial process to gain FDA approval for their products. If RTT siphoned off patients with life-threatening illnesses from clinical trials, particularly for trials of medications serving limited populations with rare diseases, drug companies might find it even harder to enroll enough patients to complete them. And health insurers will not pay for drugs that lack FDA approval. […]

RTT’s true beneficiaries may be new drug startups that are neither “patient-oriented nor compassionate, trying to create buzz for their product,” Zuckerman said. A biotech startup, she speculated, might be struggling with the high costs of making its product, and be happy to find wealthy, desperate patients willing to pay the freight. This might be particularly attractive since RTT gives patients only limited rights to sue, even if they are seriously harmed by defective products.

Unscrupulous doctors also might benefit, she added, since the law does not place any restrictions on the fees they may charge patients to administer the drug and monitor their progress. […]

Read the original article here.

Why Are Celebrities Removing Their Breast Implants?

Other Cancers
Amelia Murphy, Cancer Prevention & Treatment Fund

Every now and then, a new celebrity is in the news after announcing her decision to remove her breast implants. They speak out about the importance of loving yourself the way you are, they post some Instagram pictures of “the new me,” and the public eagerly reads the related articles in tabloid magazines.

But most of these women aren’t just talking about body image; they are getting their implants removed because of their health. Breast implants can make some women so sick that removal is their best hope for feeling like themselves again.  Several celebrities are trying to spread this information to the general public.

Crystal Hefner, Hugh Hefner’s wife, opened up about her breast implant horror story on Facebook. She announced her implants had been slowly poisoning her and causing unexplained back pain, cognitive problems, constant neck and shoulder pain, recurring infections, and many other symptoms. Once she removed her breast implants, she instantly felt an improvement and continues to feel better. [Read more about her story in this Forbes article]

Yolanda Foster, of Real Housewives fame, removed her breast implants when she found out her silicone implants had ruptured and were leaking into her body. The silicone was making the symptoms of her Lyme disease even worse. She felt much better once she removed her implants.

Linda Blair, actress in the horror movie The Exorcist, described her experience with breast implants as a nightmare. After removing her implants, she advocated for the FDA to make sure breast implants are actually studied to be safe.

Mary McDonough, a child star in The Waltons who appeared as an adult in shows such as ER and Will and Grace, attributes her autoimmune disease (lupus) to her breast implants. She was healthy before getting implants, and it was only after her implants were removed that she immediately started to feel better. She has been one of the most outspoken celebrities on the risks of breast implants.

Karen McDougal is a former Playboy Playmate and current model who made the decision to have her implants removed after months of feeling sick. She has spoken out about the risks of breast implants in USA Today and People Magazine.

Mariel Hemingway, Sharon Osbourne, and Stevie Nicks are just a few of the other celebrities who chose to remove their breast implants because of serious health problems.

Celebrities are bringing attention to the health problems that thousands of women with implants have suffered from for decades.

First, a little history:

Women have been getting breast implants since the 1960’s, and although silicone gel implants were drastically restricted for many years during the mid-1990’s through 2005 because of safety concerns, the FDA approved them again in 2006 based on short-term studies done by breast implant manufacturers. FDA also required the manufacturers to do larger, longer-term studies after that, in order to make sure they were safe (these are called post-market studies).

These longer-term studies had a lot of problems, and most women did not stay in the studies long enough to provide useful scientific information.  However, studies have shown that the longer women have silicone breast implants, the more likely they are to experience problems with them.  FDA reported that the studies found that as many as 1 out of every 5 women who get silicone breast implants for cosmetic reasons need to remove their implants within 10 years.[1] This number rises to 1 out of every 2 women if they got reconstruction after a mastectomy.[1]  Were the women who dropped out of the studies the ones that were more likely to have health problems, or less likely?  You can read more about the unanswered questions from these studies here.

Breast implants were approved by the FDA even though research showed that between 15% and 20% of first-time augmentation patients will need additional surgery to fix implant problems within 3 years, whether the implants are filled with silicone gel or saline. [2][3] The chances of needing additional surgery increases as time goes on — 28% of women are on the second set of implants after 3 years, and this number doubles when the women have their implants for 6 years. The percentage is even higher than that for mastectomy patients whose implants were for reconstruction.

What usually goes wrong?

  • Rupture: All breast implants will eventually break, sometimes within a few months or years, and usually within 10 years.
  • Capsular Contracture: This is when the breasts get firm, then hard, and they can be very painful. Breast implants are a “foreign body” and the natural response for most women is that their body forms scar tissue around the implant, inside their body, to protect their body from this “foreign invader.”  This is a natural process. However, it’s called capsular contracture when the scar tissue tightens or hardens around the implants and causes abnormal firmness, hardness, or pain.
  • Pain: Besides pain caused from capsular contracture (see above), breast implants can cause back, neck, and shoulder pain because of their weight. Leaking silicone gel can also cause a painful burning sensation.
  • Autoimmune issues:  Experts disagree on whether breast implants cause specific autoimmune diseases.  However, the fact that implants can cause cancer of the immune system (ALCL) certainly makes it more likely that implants can cause other autoimmune problems.  FDA scientists found that women with ruptured and leaking silicone gel breast implants were more likely to have fibromyalgia, a painful autoimmune disease.[5]  Many women have reported suffering from autoimmune symptoms such as joint pain, hair loss, dry eyes, or mental confusion after getting breast implants, and have also reported that these symptoms often improve or disappear after removing the implants. One study even showed the autoimmune symptoms got better for 3 out of 4 women after they removed their implants.[6]
  • Constant flu-like symptoms: Many women report feeling constantly tired or like they’re trying to get over the flu.
  • Learn more about complications from breast implants in FDA’s consumer handbook.

Besides health problems, some celebrities decide to remove their implants simply because they were annoying or embarrassing. Just to name a few, Heather Morris, Heidi Montag, Pamela Anderson, Victoria Beckham, and Jane Fonda all removed their implants for this reason.

Plastic surgeons refer to breast augmentation as a very simple surgical procedure, and as a result many people think of breast implants as an insignificant surgery with few health risks.  Hearing about celebrities who removed their breast implants sometimes makes women think twice about getting them in the first place.  It helps remind all of us to do careful research before making any decision about putting something inside your body.

 

ALCL Update: In March 2017, the U.S. Food and Drug Administration (FA) updated its website to report that breast implants could cause a type of cancer of the immune system called Anaplastic Large Cell Lymphoma (ALCL). [4]  No celebrities have reported ALCL from their breast implants. .

 

Are you considering breast implants? Find out more information here.

Are you thinking about removing your breast implants? Find out more information here.

Are Breast Implants Safe for Cancer Patients?

Breast Cancer
Diana Zuckerman, PhD and Patricia B. Lieberman, PhD, Cancer Prevention & Treatment Fund

Although the Institute of Medicine’s report on breast implants is now very outdated, there are still plastic surgeons and other breast implant advocates that quote it.  The purpose of this article is to explain what that report did and did not include.

At the time the Institute of Medicine report was published in 1999, the major controversy about breast implants was whether it could cause connective-tissue diseases or autoimmune diseases.  There were only 17 studies on the subject at the time, but the conventional wisdom was that these studies proved that breast implants are safe.  However, a careful review of the results paints a different picture.

    • These studies do not provide a comprehensive evaluation of diseases among breast implant patients. Most evaluate a few connective-tissue diseases, including such rare diseases as scleroderma and lupus. The studies would have to be much larger to determine whether implants cause these diseases. They would have to include a wider range of health information, including cancer, breast pain, need for additional surgery, and other questions, to conclusively determine if implants are safe.
    • Even for the illnesses that they evaluate, the studies have limitations. In order to conduct an accurate study of implant patients’ health, patients should undergo a comprehensive medical exam. In contrast, most of these studies relied on medical records, which are likely to omit symptoms that the doctor considers less important. A few of the studies relied on self-reported illness, which were criticized because patients might exaggerate their health problems. However, the least meaningful studies were probably those that relied on hospital records; few implant patients would have been hospitalized for their symptoms, since connective-tissue disease, breast pain, and most other health problems that implant patients have reported do not require hospitalization.
    • The studies included women who had implants for a short period of time, such as a few months or years. If implants cause connective-tissue diseases, it would be expected that the disease would develop over a period of years. Diseases might also be more likely after an implant breaks. Therefore, a well-designed study would include women who had implants for at least 7-10 years, not an average of 7-10 years.
    • Most of the studies do not evaluate saline implants. Only one of the studies specifically evaluated the health of women with saline implants.
    • Many of the studies do not evaluate the safety of implants for breast cancer patients.

Mastectomy Patients and Implants

The studies are particularly unpersuasive regarding the health of mastectomy patients. Of the cohort studies, only eight included an analysis of mastectomy patients. Four of the eight studies showed higher rates of diagnosis or symptoms of connective-tissue diseases among women with implants, but in one the difference did not reach statistical significance. The remaining studies may have been too small or may not have followed implant patients long enough to detect significant increases in disease. The case-control studies contained too few breast cancer patients to be meaningful.

Cohort Studies

Cohort studies compare women with breast implants to a group of women who are similar in terms of age, race, and health who did not have breast implants.

Edworthy et al., 1998

  • Does the study include mastectomy patients receiving implants? NO

Friis et al., 1997

  • Does the study include mastectomy patients receiving implants? YES
  • If so, how many? 1,435 of 2,570
  • Diseases studied: Any classic connective-tissue disease, including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma. Also looked at “other and ill-defined” rheumatic conditions.
  • Were mastectomy patients analyzed separately from augmentation patients? YES
  • Minimum length of time with implants included in study: To be in this study a woman could have had implants for less than one year.
  • Average length of time with implants: 7.2 years for reconstruction group, 8.4 years for augmentation group.
  • Additional notes: Rates of scleroderma, lupus, and Sjogren’s syndrome in mastectomy patients receiving implants was 30% higher than expected. According to the authors, the study had only limited power to detect an increased risk of any specific connective-tissue disease. Only women who were hospitalized were categorized as ill, not outpatients.

Gabriel et al., 1994, “Mayo Clinic Study”

  • Does the study include mastectomy patients receiving implants? YES
  • If so, how many? 125 of 749
  • Diseases studied: Any classic connective-tissue disease, including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma. Also looked at other disorders such as Hashimoto’s thyroiditis, cirrhosis, sarcoidosis, and cancer.
  • Were mastectomy patients analyzed separately from augmentation patients? YES
  • Minimum length of time with implants included in study: To be in this study a woman could have had implants for less than one year.
  • Average length of time with implants: 7.8 + 5.5 years
  • Additional notes: Women with breast implants had a 35% higher rate of arthritis, which was not statistically significant (relative risk: 1.35). Morning stiffness was 81% higher for implant patients, which was significantly higher than in women without implants (relative risk: 1.81). The authors estimated that they would need to have studied 62,000 women with implants for an average of 10 years to detect a 100% increase (or less) in rare diseases such as scleroderma.

Giltay et al., 1994

  • Does the study include mastectomy patients receiving implants? YES
  • If so, how many? Approximately 56 of 235
  • Diseases studied: Rheumatic complaints, use of anti-rheumatic drugs, and medical consultations regarding rheumatic symptoms. For those reporting rheumatic symptoms, a rheumatologist made an assessment of the likelihood of a rheumatic disease.
  • Were mastectomy patients analyzed separately from augmentation patients? NO
  • Minimum length of time with implants included in study: Two years
  • Average length of time with implants: 6.5 years with a range of two to 14 years
  • Additional notes: Women with silicone breast implants reported significantly more rheumatic complaints than controls, but there was no evidence of increased prevalence of common rheumatic diseases, such as fibromyalgia, rheumatoid arthritis, or Sjogren’s disease. If mastectomy patients are more vulnerable to diseases than augmentation patients, the results may not accurately describe the health risks for mastectomy patients, since they were a small minority of the women in the study.

Hennekens et al., 1996, “Harvard Women’s Health Cohort Study”

  • Does the study include mastectomy patients receiving implants? YES
  • If so, how many? 18% of 10,830
  • Diseases studied: Any classic connective-tissue disease including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma. Also included mixed connective-tissue disease.
  • Were mastectomy patients analyzed separately from augmentation patients? YES
  • Minimum length of time with implants included in study: To be in this study, a women could have had implants for one year.
  • Average length of time with implants: Not stated, but the authors analyzed the women in three groups; up to four years, five to nine years, and 10 or more years after receiving implants and showed no increased risk with increased duration of exposure.
  • Additional notes: Implant patients had a 25% higher rate of connective-tissue disease, whether they were reconstruction or augmentation patients (relative risk: 1.25). This was statistically significant and the researchers concluded that there is a small increased risk of connective-tissue disease among women with implants.

Nyren et al., 1998

  • Does the study include mastectomy patients receiving implants? YES
  • If so, how many? 3,942 of 7,442
  • Diseases studied: Hospitalizations for classic connective-tissue disease including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma. Also studied hospitalizations for related diseases.
  • Were mastectomy patients analyzed separately from augmentation patients? YES
  • Minimum length of time with implants included in study: One month
  • Average length of time with implants: Six years for reconstruction patients, 10.3 years for augmentation patients.
  • Additional notes: Only women who were hospitalized for connective-tissue disease were categorized as ill, not outpatients. The authors acknowledge that the sample size was too small to draw conclusions about links between breast implants and rare diseases they studied, such as scleroderma.

Park et al., 1998

  • Does the study include mastectomy patients receiving implants? YES
  • If so, how many? 207 of 317 implanted women
  • Diseases studied: Signs and symptoms of connective-tissue disease, such as a antinuclear antibodies, rheumatoid factor, joint pain, fatigue, Raynaud’s syndrome, etc.
  • Were mastectomy patients analyzed separately from augmentation patients? YES
  • Minimum length of time with implants included in study: Not specified
  • Average length of time with implants: Six years for reconstruction patients, five years for augmentation patients.
  • Additional notes: Because the sample size was so small, a health risk would have to exceed 320% for reconstruction patients and 1600% for augmentation patients in order to be statistically significant. In addition, approximately half of the women had implants for less than six years. Because of these shortcomings, this study does not provide useful information.

Sanchez-Guerrero et al., 1995, “The Harvard Nurses’ Health Study”

  • Does the study include mastectomy patients receiving implants? YES
  • If so, how many? 525 of 1183 for cancer or prophylaxis
  • Diseases studied: Any classic connective-tissue disease, including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma. Excluded women with milder or atypical cases of connective-tissue disease.
  • Were mastectomy patients analyzed separately from augmentation patients? NO
  • Minimum length of time with implants included in study: One month
  • Average length of time with implants: 9.9 + 6.4 years
  • Additional notes: According to the authors, the study does not exclude small health risks of implants that would be of public health importance. The study was designed to minimize “reporting bias” of health problems by implant patients by excluding any health problems diagnosed after May 1990, which was six months before the major media coverage of implant problems. They did not minimize bias in the opposite direction; for example, they included women who only had implants for one month. Also, they should have excluded women who reported receiving breast implants from 1952 to 1961, prior to the invention of implants. Including these women and their inaccurate statements increased the average years of implantation.

Schusterman et al., 1993

  • Does the study include mastectomy patients receiving implants? YES, all were mastectomy patients.
  • If so, how many? 250 implanted compared to 353 who had autogenous tissue transplants.
  • Diseases studied: Patients were considered to have rheumatic disease if they had been seen by a physician who made the diagnosis on clinical grounds with corroborating laboratory evidence and had prescribed therapy.
  • Minimum length of time with implants included in study: 10 months
  • Average length of time with implants: Less than 2.5 years
  • Additional notes: Length of follow up was too short to be meaningful. The authors state that the report must be considered preliminary because the onset of autoimmune disorders could occur 2-21 years after implantation.

Weisman et al., 1988

  • Does the study include mastectomy patients receiving implants? NO

Wells et al., 1994

  • Does the study include mastectomy patients receiving implants? NO

Case-Control Studies

Of the six case-control studies, only two specified that they included any women with mastectomies, and each included only one woman. Therefore, these studies are not useful for evaluating whether implants are safe for mastectomy patients.

Burns et al., 1996

  • Design: Case-control study of women with scleroderma.
  • Does the study include mastectomy patients receiving implants? YES, but only one

Englert et al., 1994

  • Design: Case-control study of women with scleroderma.
  • Does the study include mastectomy patients receiving implants? YES, but only one

Goldman et al., 1995

  • Design: Case-control study of women with rheumatoid arthritis and other connective-tissue disease.
  • Does the study include mastectomy patients receiving implants? Doesn’t specify

Hochberg et al., 1996

  • Design: Case-control study of women with scleroderma.
  • Does the study include mastectomy patients receiving implants? NO

Strom et al., 1994

  • Design: Case-control study of women with lupus.
  • Does the study include mastectomy patients receiving implants? NO

Williams et al., 1997

  • Design: Case-control study of women with connective-tissue disease.
  • Does the study include mastectomy patients receiving implants? NO

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