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NCHR Comments on FDA’s Notice on the Modified Risk Tobacco Product Application for Copenhagen Snuff Fine Cut

National Center for Health Research, January 21, 2020


National Center for Health Research’s Public Comments on FDA’s Notice on the Modified Risk Tobacco Product Application for Copenhagen® Snuff Fine Cut

Thank you for the opportunity to comment on the FDA Notice on the Modified Risk Tobacco Product Application for Copenhagen Snuff Fine Cut.

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

We strongly oppose the approval of this modified risk application for Copenhagen Snuff Fine Cut with the claim “IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer” for the following reasons:

  • This safety claim could result in a higher number of dual users, and there is not sufficient evidence to suggest that dual use would reduce the risk of lung cancer. 
  • Even if an individual’s complete switch from combustible tobacco products to this product reduces a user’s risk of lung cancer, we agree with the FDA’s own website, which indicates that the use of smokeless tobacco products increases the risks of other types of cancers, such as oral, esophageal, and pancreatic cancer, as well as other diseases.
  • Because snuff has risks, data are needed to ensure that the marketing of this product as a modified risk product would not increase the number of non-smokers who would start using tobacco products. Increased use is likely, especially among teens and young adults, because, as with vaping, when people hear claims that a product is “safer,” they often misinterpret that to mean the product is “safe.”
  • Research has already shown that individuals who start using smokeless tobacco products, such as this product, are more likely to start using combustible tobacco products.
  • The modified risk statement could be interpreted as suggesting that Copenhagen Snuff Fine Cut can be used as a smoking cessation strategy. However, the sponsor has not provided scientific evidence that using this product helps people stop smoking. 
  • Although smoking and lung cancer deaths have both gone down in Sweden and Norway, the company has not provided evidence that these “favorable public health outcomes” are due to smokeless tobacco products. In addition, there is no evidence that additional reductions would occur in the U.S. market if this modified risk reduction application is approved, because the healthcare system, tobacco reduction campaigns, popular products and cultural influences are different than they are in Sweden and Norway.

In summary, a modified risk statement may encourage people who do not smoke to begin using this tobacco product and could lead to more dual usage, therefore, this product would not reduce the health risks for lung cancer.

For questions or more information, please contact Nina Zeldes, PhD at the National Center for Health Research at nz@center4research.org or at (202) 223-4000.

References

  1. US Food and Drug Administration. Executive Summary of USSTC MRTP Application for Copenhagen® Snuff Fine Cut. Silver Spring, MD: US Food and Drug Administration; 2020. https://digitalmedia.hhs.gov/tobacco/static/mrtpa/Copenhagen/2.3-executive%20summary%20_Redacted.pdf

Everything is designed for men, even drugs

Producers Kim Mas and Ranjani Chakraborty, Vox: January 16, 2020


This short video explains why designing medicine around the “average man” is so dangerous. Most things in society are built for, and designed around, a specific “reference man.” This “standard human” is usually a white male in his 30s who weighs around 155 pounds. When we design everything from cars, to air-conditioned offices, to city streets, reference man is the default user. And when it comes to healthcare, that can mean deadly effects for women.  Watch the video above to find out how dosages are determined with “reference man” in mind. After dozens of women got into car accidents under the influence of sleeping pills they’d taken the night before, the FDA had to tell women to cut their dose in half; it turned out, women metabolize Ambien’s active ingredient twice as slowly as men. What was supposed to be a “gender-neutral” dose was anything but. Diana Zuckerman, president of the National Center for Health Research, explains why we need more inclusivity in clinical trials — for women, for people over 65, and for people of color.

https://www.youtube.com/watch?v=CVdn-2KE2bs

Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound

David Lim, MedTech Dive: January 10, 2020


FDA warning letters to medical device manufacturers slid by nearly 90% between 2015 and 2019, but may be set to rebound upward in 2020, according to device center Associate Director for Compliance and Quality Erin Keith. Warning letters are used by FDA to alert a manufacturer it “has significantly violated FDA regulations,” such as misstating what a device is indicated for or having poor manufacturing practices, according to the agency.

Warning letters are used by FDA to alert a manufacturer it “has significantly violated FDA regulations,” such as misstating what a device is indicated for or having poor manufacturing practices, according to the agency.

The downturn in Center for Devices and Radiological Health warning letters from 81 in fiscal year 2015 to nine in 2019 comes amid a major effort to reorganize the FDA device center that proved “very disruptive to the compliance office,” Keith said.

“It is organized in a different way now than it was in the past, so the processes have had to be worked out,” Keith told the Food and Drug Law Institute’s annual compliance conference in December. “We can’t issue a warning letter if we don’t do it timely, according to the evidential requirements.”

[…]

Still, some patient safety advocates are concerned the drop in warning letters cannot be entirely attributed to the restructuring changes at the agency.

“I don’t think that downward trend can adequately be explained by the reorganization that is taking place,” Public Citizen Health Research Group Director Mike Carome said.

Diana Zuckerman, president of the National Center for Health Research, said the trend is emblematic of a regulator that is overly focused on pleasing industry.

“It could have several different causes, reorganization could be one. [Medical Device User Fee Amendments] regulations could be part of it, which requires more meetings. But there is this emphasis on customer service, which is defined as making life easier for the industry. Industry is an important customer, but so is the American taxpayer,” Zuckerman said.

Over the past decade, the device center has also focused on shifting how it communicates with manufacturers, focusing on pushing companies to prioritize making decisions that improve quality and patient outcomes rather than simply achieving compliance with regulatory requirements. The goal, Keith said, is to have companies address potential issues before they rise to the warning letter stage.

“We as a philosophy for the center don’t want to have to go to enforcement,” Keith said. “We want to get to problems when they are smaller and easier to fix.”

Another method FDA has utilized is increasing the number of alternative methods of disseminating information, such as issuing Letters to Health Care Providers and Safety Communications. For example, in April 2019, the agency issued a safety communication alerting patients and providers of mammography problems at a medical clinic in Ohio, noting the facility “was unable to meet the parameters for a key quality control test on the day of the 2018 annual inspection.” FDA noted in the safety communication quality problems at East Palestine Family Medical Clinic dated back to October 2017, and recommended patients screened at the facility receive an additional mammography.

“I think it’s important that we won’t wait to let people know that there is an issue patients and providers need to know about by letting a compliance process catch up to documentation,” Keith told MedTech Dive. “Sometimes we can get what we need, have the public know what’s going on and get a change by sharing information. When it’s more appropriate to use a more traditional compliance activity, we will do that.”

[…]

Read the original story here

Schools Seek Ways to Curb Vaping Among Students

Tawnell D. Hobbs, The Wall Street Journal: January 6, 2020


[…]

An estimated 5.4 million middle- and high-school students in the U.S. recently used e-cigarettes, a vaping device, according to a federal survey released in December. That is 20% of all students, far more than the 4.3% that used cigarettes.

The Centers for Disease Control and Prevention reported 2,561 cases of hospitalizations for lung injury involving e-cigarettes, and 55 deaths, as of Dec. 27. The majority of cases are linked to products containing THC, the psychoactive ingredient in marijuana.

School administrators say vaping is more challenging to tackle on campus than regular cigarettes. Vape devices are typically battery-powered and made to look like everyday items, such as pens, lipstick cases and USB drives.

They come in child-friendly flavors, from bubble gum to strawberry cheesecake, and have pleasant smells. Students can take quick whiffs undetected while sitting in class or walking down a hallway, with exhaled vapor dissolving quickly into the air or held in to be absorbed, unlike lingering smoke from lit cigarettes.

School resource officers in Chico, Calif., use 18-years-olds, under the nicotine purchasing age of 21, as decoys to bust businesses selling tobacco products used for vaping; officials said eight clerks have been cited. The officers also allow students to trade vape devices for coupons for pizza and smoothies, with no questions asked. In four weeks, about 50 vapes were turned in, said Sgt. Greg Rogers.

“We’re just trying something different,” Sgt. Rogers said. “We wanted it to not be punitive.”

Jupiter Community High School in Palm Beach County, Fla., in October banned students from using the restroom during class periods unless for emergencies and with an administrative escort. The rule has since been lifted.

“Parents were frustrated with the fact that their children weren’t just allowed to go to the restroom,” said June Eassa, a Palm Beach school assistant superintendent.

Plainwell Community Schools in Michigan is starting random nicotine testing of high-school students in extracurricular activities in January. Students testing positive are restricted in participating in their activity.

[…]

Juul Labs said that it has suspended broadcast, print and digital product advertising in the U.S. “We are focused on resetting the vapor category in the U.S. and earning the trust of society by working cooperatively with regulators, public health officials, and other stakeholders to combat underage use,” the company said.

According to Juul’s website, “one 5% strength JUUL pod is designed to replace one pack of cigarettes in nicotine strength,” and saves money.

Researchers are concerned that there doesn’t seem to be a standard of what should be a normal vape dose, leaving students to grossly overuse the product.

“There’s a certain understanding that you don’t smoke more than a pack a day,” said Diana Zuckerman, president of the National Center for Health Research. “With vaping, because it’s new and because all these products vary, there aren’t the sorts of standards that help people restrict what they’re doing.”

[…]

Read the original story here

Breast Implant Working Group’s Comments on FDA’s Draft Guidance to Improve Patient Communication on Breast Implants

Scot Glasberg, MD,  Diana Zuckerman, PhD,  Alan Matarasso, MD, Karuna Jagger, Raylene Hollrah, Jamee Cook, and Maria Gmitro, December 23, 2019


Download the comment here.

Comment to the FDA Docket on the FDA’s Draft Guidance to Improve Patient Communication on Breast Implants

A Working Group comprised of two former presidents of the American Society of Plastic Surgeons, the president of a national research center, and four nationally respected patient advocates came together to find common ground regarding the risks of breast implants.   As individuals (Dr. Scot Glasberg, Dr. Alan Matarasso, Dr. Diana Zuckerman, Ms. Karuna Jagger, Ms. Raylene Hollrah, Ms. Jamee Cook, and Ms. Maria Gmitro), we are urging that the FDA require a black box warning and Patient Informed Consent Check List that provides information about the risks of cancer, breast implant illness, and other serious health problems in explicit and easy-to-understand wording that all individuals considering breast implants can understand, regardless of educational level or stress that is inevitable when a person  is considering surgery.

Black Box Warning

The FDA’s draft Black Box warning is too vaguely worded on BIA-ALCL and breast implant illness, and includes jargon that will not be understood by all patients.  For example, it should specify that breast implants can cause ALCL, breast implants are not lifetime devices (instead of FDA’s proposed Black Box wording that they are “not considered lifetime devices), replace technical jargon, and be more explicit about the evidence regarding breast implant illness instead of making it sound like it is not a real risk.

The FDA draft Black Box states that “breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).”  Association implies correlation rather than causation.  In fact, the evidence is clear that breast implants can cause BIA-ALCL.

The FDA draft says that the rates of BIA-ALCL “are not well defined.”  Although correct, that terminology will not be understood by all patients.  Instead, it should state that the rates “are not known.”

We agree with the FDA draft that it is important to illustrate the seriousness of BIA-ALCL by stating that “Some patients have died from BIA-ALCL.”

The draft Black Box wording regarding symptoms of breast implant illness would be confusing to patients.  It refers to systemic symptoms, which is the correct term, but not one that all patients would understand.  It does not mention breast implant illness, which although not an established medical term, is one that is well understood by patients.  The FDA draft background paper and Black Box warning both state that “some” patients with breast implants “have reported a variety of systemic symptoms,” which implies that the numbers of women with these symptoms is small and that they reported the symptoms but that they haven’t been diagnosed.  That is incorrect.  The wording should be changed to “patients have experienced a variety of symptoms.”  The FDA proposed Black Box statement that “some patients report complete resolution of symptoms” again implies that these improvements are reported but not medically confirmed.

On the contrary, a review of several well-designed studies by De Boer et al. (2017) found that most women with breast implant illness who had their implants removed and not replaced were confirmed by physicians to have complete or substantial improvement in their symptoms and overall health.

In addition, the FDA draft Black Box does not mention the risk of autoimmune/connective tissue diseases.  The Black Box should specify that “several studies suggest that women with silicone gel or saline-filled breast implants have a small but significant increase in their chances of developing certain autoimmune or connective tissue diseases.” That statement is supported by the largest long-term study to date, by Watad et al. (2018), a retrospective analysis of 24,651 women with breast implants (confirmed by medical records) and 98,604 matched women who did not have breast implants. The strongest association with breast implants (OR>1.5, p<0.001) was recorded for Sjögren’s syndrome, systemic sclerosis (scleroderma) and sarcoidosis, based on new medical diagnoses made after the women received breast implants, which were included in medical records during a period of up to 20 years.  In addition, (Coroneos et al. 2019) reported that Allergan’s study of 60% of the almost 50,000 women they enrolled in their study submitted to the FDA, physicians’ diagnoses of their patients two years after their implant surgery found statistically significant increases in fibromyalgia, rheumatoid arthritis, and lupus compared to the general population.  Although the Mentor data reported in that study are very flawed, the Allergan data, which were provided to the FDA, seem solid.

Patient Informed Consent Checklist

The Breast Implant Working Group created a checklist that was provided to the FDA in October.  This checklist has been endorsed by the American Society of Plastic Surgeons, the National Center for Health Research, Breast Cancer Action, Our Bodies Ourselves, National Women’s Health Network, Jacobs Institute for Women’s Health, Breast Implant Victims Advocacy, Just Call Me Ray, and Breast Implant Safety Alliance.  It was also supported by more than 77,000 individuals who signed a petition that the Working Group provided to FDA officials on December 9, 2019

We agree with the FDA that the purpose of a patient checklist is to provide information for patients considering breast implants for augmentation or reconstruction, so that they can carefully weigh the risks and benefits of breast implants and make the decision that is right for them. Based on our experience with patients, we urge the FDA to ensure that the checklist is:

  • Brief and easy-to-understand, formatted with information on specific issues that are presented succinctly;
  • Jargon-free. Keep in mind that the average reading level in the U.S. is 6th
  • Organized to focus on the information that patients are less likely to obtain from other sources. It should not start with lengthy sections that are not especially interesting to patients.

Focus and Organization of the Checklist

The goal of the checklist should be to provide the most essential information that patients might not get from standard informed consent forms. It is therefore essential that the checklist provide information that thousands of implant patients have stated they were not warned about.  For that reason, the checklist should not focus on surgical and cosmetic risks, which are the types of risks that all patients are warned about in standard consent forms.  Instead of the almost full page of mostly surgical risks that are listed at the beginning of the FDA’s draft checklist, such risks should be summarized very briefly in one sentence, with the checklist focused on other risks that patients could otherwise not be aware of.  Similarly, cosmetic and local risks should be listed last in the checklist, since that information is more likely to be provided through other means.

The FDA draft checklist starts with “Considerations for a Candidate for Successful Breast Implantation,” cancer risk and a short section on “systemic illness.”  We suggest shorter, more focused headings and information to make the checklist more engaging and easy to read.

Who shouldn’t get breast implants?

The above heading should replace “Considerations for a Candidate for Successful Breast Implantation,’ since that latter heading implies that the patient characteristics listed are the only ones that would reduce the chances of complications or other problems.  In terms of content, the FDA draft wording on who should not get breast implants contains important information but is much too long and includes information that could be summarized.  The goal of the checklist should be to provide the most essential information that patients might not get from standard informed consent forms.  We recommend a short summary regarding active infections, cancer, or wound healing, and the following wording instead:

I understand that the safety of breast implants was never studied for people who have autoimmune symptoms or diseases, or a family history of those diseases. Breast implants may be more likely to cause serious health problems and symptoms for these people.  In addition, breast implants may not be safe for anyone with a weakened immune system or certain genetic risk factors that have not yet been identified.

Risk of Cancer: BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma)

We recommend that the FDA’s draft wording for BIA-ALCL could be improved as follows:

I understand that there is a small risk for me to develop BIA-ALCL, a cancer of the immune system. BIA-ALCL is a type of lymphoma that develops on or around the scar capsule that surrounds the breast implant. I understand that the symptoms of BIA-ALCL include breast swelling, lumps, pain, and asymmetry that develop after surgical incisions are completely healed, usually years after implant surgery.

Treatment for BIA-ALCL includes removal of the implant and scar capsule, and, if not treated early, may include chemotherapy and radiation. This diagnosis and treatment may be at my own expense and is not always covered by insurance. 

Systemic Symptoms:  Breast Implant Illness

As noted earlier, “Breast Implant Illness” should be the term used, since “systemic symptoms” is not a term that all patients would understand.  Also as noted earlier, the FDA draft guidance and draft checklist consistently imply that the number of women reporting symptoms of breast implant illness is small and that there is no research evidence that the symptoms are caused by their implants.  For example, the FDA’s draft wording that “some women report” implies that a small number of women are claiming an illness that isn’t real.  It is more accurate and meaningful to patients to say that several studies support the apparent causal link to breast implant illness symptoms (Watad et al 2017 and Colaris et al. 2017) and to symptom improvement after implants are removed (DeBoer et al. 2017), for example).  It should also state that the largest, long-term studies also indicate a statistically significant increase in certain autoimmune or connective tissue diseases, as summarized on page 2 of this document, citing Watad et al. 2018 and Coroneos et al. 2019). For that reason, ASPS, researchers, women’s health organizations, and patient groups endorse the following wording:

I understand that because of the lack of long-term safety data, we are still learning about the health problems that result from breast implants.  To date, thousands of women have reported to the FDA or to researchers that they have experienced serious health problems that several studies have linked to their breast implants. This may occur either immediately after getting implants or years later. These often include symptoms such as: joint and muscle pain or weakness, memory and concentration problems, chronic pain, depression, fatigue, chronic flu-like symptoms, migraines, or rashes and skin problems.

Several studies of women with breast implants have shown that they are significantly more likely to be diagnosed with one or more of the following diseases compared to other women:  Chronic Fatigue Syndrome; Multiple Sclerosis (MS); Rheumatoid Arthritis (RA); Sjögren’s syndrome; and Systemic Sclerosis/Scleroderma.

Although women who develop these symptoms or diseases can’t be certain that they were caused by breast implants, several studies indicate that most symptoms improve partially or completely after having their implants and capsules removed.

Breast-Implant Specific Risks

This heading in the FDA’s draft Checklist is misleading, since BIA-ALCL and many other risks of breast implants are specific to breast implants.  More important, this section is much too long and includes too many topic areas.

We therefore recommend the following shorter, more specific sections:

How long do breast implants last?

It’s essential that patients understand what it means when experts say that breast implants “don’t last a lifetime.”  Since many implant patients are young, some think that means they only last 30-50 years.  Even saying “the longer you have them, the more likely they are to break” can be misinterpreted to refer to 30 or 40 years later.  For that reason, the Working Group Checklist specifies “Implants may rupture or leak at any time, and that is more likely the longer you have them” and that “it is likely that I will need other surgeries related to my breast implants over the course of my life.”

The wording should be succinct, explicit, and easy to understand.  Augmentation patients are already aware that their insurance policy does not cover cosmetic surgery, but it is important for them to also know that insurance is unlikely to cover subsequent surgeries due to complications or breakage, since they might mistakenly assume that problems related to implants will be covered even if the initial cosmetic surgery is not.  We recommend the following wording:

I understand that breast implants are not expected to last for the rest of my life.  Implants may rupture or leak at any time, and that is more likely the longer you have them.  In addition, it is likely that I will need other surgeries related to my breast implants over the course of my life.  If I am a cosmetic surgery patient, my health insurance policy may refuse to cover these surgeries for removal, and probably would not cover replacement. These additional surgeries and procedures can include implant removal with or without replacement, muscle and tissue repair, scar revisions, MRI diagnostic exams, or other procedures. I understand that undergoing multiple surgeries may increase my chances of permanent breast deformity.

Chemicals and Metals in Breast Implants

Patients should be informed about the chemicals and metals in the specific make and model of breast implants they are considering.  Since the checklist is for all breast implant patients, it should include a brief, general statement about chemicals and heavy metals, but each patient should get separate, more detailed information about the specific model of implant they are considering.  We recommend the following wording for the checklist:

I understand that all breast implants contain chemicals and small amounts of heavy metals that may cause health problems. I understand that most of these chemicals are confined to the shell of the implant or stay inside the shell.  However, small quantities have been found to diffuse (bleed) from or through the implant shell, even if the implant is intact and not ruptured.

Rupture and Leakage

Patients would benefit from a section with a heading of “Rupture and Leakage.”  Although this overlaps with the issue of how long implants last, more specific information about silent rupture is important.  We recommend the following wording for the checklist, understanding that if FDA no longer recommends MRIs after 3 years, that wording should be revised, but the explicit information about the risks of silicone migration should be included:

I understand that the longer my breast implants are in place, the more likely they are to rupture, especially after the first few years. When a saline implant ruptures, it usually deflates quickly. When a silicone gel implant ruptures, I may not notice any changes and the rupture may not be detected by my doctor or by mammogram, MRI, or sonogram. I understand that an MRI is recommended for silicone gel breast implants 3 years following surgery and every 2 years after that to check for silent rupture, and that these MRIs often are not covered by health insurance. I understand that silicone may migrate from the implant into nearby tissues such as the chest wall, lymph nodes, upper abdominal wall, and into organs such as the liver or lungs where it cannot be removed. Since migrated silicone can cause health problems, it is currently recommended that any ruptured silicone implant should be removed as soon as possible. I understand that, if needed, treatment of these conditions may be at my own expense and not covered by insurance or a manufacturer warranty.

Capsular Contracture

Capsular Contracture is a common complication that therefore should have its own heading.  Our recommended wording is as follows:

I understand that one of the most common complications of breast implants is when the scar tissue capsule that forms around the implant hardens. In some cases, this can be quite painful, distort the shape of the breast, and can make mammography more painful and less accurate. Removing the implant and capsule without replacing the implant is the only recommended way to guarantee that this problem is corrected.

Breast Cancer

Breast cancer issues should be a separate heading in the checklist, not part of the section on ACLC, in order to avoid confusion.  Our recommended wording is as follows:

I understand that all breast implants can interfere with mammography and breast exams, possibly delaying the diagnosis of breast cancer. I understand that if I get breast implants, I should inform the mammography technologist about the implants and ask for additional views to improve the accuracy. I understand that mammography can also cause the breast implant to rupture or leak.

Interference with Breastfeeding

Since the data are lacking, our recommended wording is as follows:

I understand that breast implants and breast surgery may interfere with my ability to successfully breastfeed.  No long-term research has been conducted to determine the possible transmission of chemicals and heavy metals in the breast milk of women with implants.

Loss of Sensation to Breast or Nipple(s)

Many women do not understand that breast implant surgery can cause loss of sensation.  While more likely among reconstruction patients, it is important to note that augmentation patients can also experience loss of sensation or painful sensitivity.  We therefore recommend this wording:

I understand that breast implants and breast surgery may cause the nipple or breast to be painful, or to have decreased sensation. These changes may be temporary or permanent, and may affect sexual response or the ability to nurse a baby.

Cosmetic Complications

Cosmetic complications should be the last section of the checklist, because like surgical complications they are often included in standard informed consent documents.  We recommend the following brief, easy to understand, but explicit warnings, such as using the term “sag” instead of ptosis:

I understand that if my breasts had slightly different shapes before surgery, they may remain slightly different after surgery. I understand that the implants may cause the breasts to look slightly different in size or shape. I understand that the implant may move from the original placement location and that may result in asymmetry or other cosmetic problems. Breast implants can cause the breasts to sag over time due to the weight of the implants. I understand that if I am not happy with the results, I may need future surgeries to improve the appearance of my breasts.

 

FOOTNOTES:

Colaris MJ, de Boer M, van der Hulst RR, Cohen Tervaert JW. (2017) Two hundred cases of ASIA syndrome following silicone implants: a comparative study of 30 years and a review of current literature. Immunologic Research 65(1):120-128. doi: 10.1007/s12026-016-8821-y

Coroneos C, Selber J, Offodile A, et al. (2019) US FDA breast implant postapproval studies: Long-term outcomes in 99,993 patients. Annals of Surgery 269(1):30-36. doi: 10.1097/SLA.0000000000002990

De Boer M, Colaris M, van der Hulst RR, Cohen Tervaert JW (2017) Is explantation of silicone breast implants useful in patients with complaints? Immunologic Research 65(1):25-36. doi: 10.1007/s12026-016-8813-y

Watad A, Quaresma M, Brown S, et al (2017) Autoimmune/inflammatory syndrome induced by adjuvants (Shoenfeld’s syndrome)—an update. Lupus 26(7):675-681. doi:10.1177/0961203316686406

Watad A, Rosenberg V, Tiasano S. et al. (2018) Silicone breast implants and the risk of autoimmune/rheumatic disorders: A real-world analysis. International Journal of Epidemiology. 47(6):1846-1854. doi: 10.1093/ije/dyy217

 

 

Roundup 2019: Breast implants, mesh, paclitaxel-coated devices among hot topics at FDA expert panels

Maria Rachal, MedTech Dive: December 23, 2019


It was a busy year for FDA’s expert advisory committees, called on to tackle many of its biggest medical device questions in 2019, new and old.

The Circulatory System Devices Panel met in June in reaction to a concern that emerged in late 2018 after a meta-analysis found a late mortality signal in patients receiving paclitaxel-coated devices. Other topics, like the benefit-risk profile of transvaginal mesh, had been hashed out in numerous meetings over the past few decades.

​Repeated meetings aren’t necessarily a negative, said Diana Zuckerman, president at the National Center for Health Research since 1999.

“We can’t think of these public meetings as a bad outcome … We wish that people weren’t being harmed by breast implants, by mesh, by Essure, and so on. But if they are being harmed, then I’d much rather there be a public meeting about it then to have it covered up,” Zuckerman said. “For breast implants especially, it’s made an enormous difference in terms of public awareness.”​

Of all the device meetings this year, none seemed to draw as much attention as a March meeting on breast implant safety. It came amid growing recognition of a type of lymphoma that can develop around the devices called breast implant associated anaplastic large cell lymphoma, or BIA-ALCL, as well as a vast collection of potentially related symptoms called breast implant illness.

In one of the clearer impacts from an advisory panel this year, FDA followed up months later by asking Allergan to initiate a worldwide recall of certain textured implants, and issuing a draft guidance outlining a black box warning and patient safety informed consent checklist to be included with the implants.

Raylene Hollrah, a breast cancer and BIA-ALCL survivor who has advocated that FDA improve breast implant safety, said that while the advocacy community has made significant strides with regulators and plastic surgeons this year, language in FDA’s draft guidance regarding breast implants’ risks is “way too vague.” Comments on that proposal are due Monday.​

“I am definitely not anti-implant,” she said. “I want women to have a choice but I want it to be a safe one.”

Better transparency on the chemicals and metals contained in breast implants remain at the top of advocates’ list, Hollrah said.

Eight months after the breast implants meetingFDA asked its Immunology Devices Panel to weigh immunological responses to devices based on different metal elements in implants.

Zuckerman said that meeting represented the first time she’d heard high-level FDA scientists and officials link certain immunological responses to devices and vocalize a need to better understand what causes that link, and which patient and product factors increase risk.

“It was very interesting because it wasn’t specific to any particular product,” Zuckerman said. “[When] there’s an advisory committee on one product, there always seems to be a lot of caution about suggesting immunological responses to implants,” adding that panelists seemed “much more open-minded about these issues than they usually are.”

One undercurrent across many meetings was inadequacy of post-approval studies and spotty adverse event reporting, leading to incomplete data with which panelists could form opinions. Once a device is commercialized, it’s very difficult to complete postmarket studies, Zuckerman said.

Even if those postmarket studies and other forms of surveillance are happening, “it’s too late for the patients being harmed,” Zuckerman said. “Most of us would much rather know that some implant that’s going into our body was adequately tested before it was put in our body. Not that it might be tested a year or two later.”

[…]

Read original story here.

I Visited a ‘Private ER’ Where People Pay Up to $5,000 a Year to Skip the Hospital— Take a Look

Hilary Brueck, Insider: December 19, 2019


In the shadow of the World Trade Center in downtown Manhattan, right down the block from a Target store, there’s a secret emergency room, tucked away on the fifth floor of an office tower.

Here, Sollis Health is staffed 24/7 with doctors who are trained in emergency medicine. They’re on-call for an elite membership of hundreds of wealthy clients who pay to skip dealing with their local ERs, where staff say conditions are like a “war zone.”

“The ER system is broken, I think everybody agrees to that,” Diana Zuckerman, president of the National Center for Health Research, told Insider, saying the country’s emergency medicine system is misused, overused, and wildly expensive.

Patients often wait more than five hours to see a doctor in a regular New York City ER. But at Sollis Health, patients can spend as little or as long with their doctors as they want, and get most of the same type of emergency care they’d receive at a hospital in a fraction of the time.

[…]

On the Upper East Side Sollis also has an MRI machine on hand, but not here. (MRIs give more detailed images of organs and soft tissue than X-rays or CT scans can.)

“Those are very, very expensive,” Zuckerman said of the MRI, X-ray, and other imaging machines. “Unless you have a lot of patients, you’re going to have to charge an enormous amount of money for each one.”

In Tribeca, Sollis shares space with a few different health companies, including one that does “executive health exams” which include lots of testing, imaging, and blood work.

[…]

Concierge services can make managing healthcare easier for patients with chronic health issues, young children, and older people.

Estimates suggest there are about 10,000 concierge doctors at work across the country.

“We can give care in the sort of one-to-one fashion that we think we would want for ourselves or we would want for our parents, when they’re sick,” Olanow said. “Basically, have the entire experience led by a physician.”

Ranging between $250 and upwards of $400 a month, the price of this kind of private care (which is billed as out of network) isn’t exactly a bargain, nor is it a particularly fair solution to the nation’s ER crisis.

“I can’t imagine this is the best solution, because it’s obviously only for people who can afford it,” Zuckerman said. “If you’re willing to spend a few thousand dollars to participate in this program, you have the money to make sure that you don’t have to wait very long for whatever it is you need.” 

[…]

Medical Professors are Supposed to Share Their Outside Income With the University of California. But Many Don’t.


For nearly two decades, Dr. Neal Hermanowicz has led the movement disorders program at the University of California’s Irvine campus, where he earns more than $380,000 a year in salary and bonuses. The widely respected expert on Parkinson’s and Huntington’s diseases adds to his income by consulting for drug companies.

Since 2014, 11 pharmaceutical companies have paid him a total of at least $588,000 for consulting, speaking and honoraria, according to federal data. For example, he has received more than $225,000 in speaking and consulting fees from San Diego-based Acadia Pharmaceuticals, manufacturer of a controversial drug for Parkinson’s-related psychosis. In 2017, he was the company’s highest-paid physician consultant in the U.S. That year, he prescribed the drug more than 180 times, costing patients or their insurers more than $445,000.

Under University of California rules aimed at discouraging excessive moonlighting, Hermanowicz should not only have reported his outside income to UC Irvine; he should also have turned over more than $200,000 to the school from 2016 to 2018, according to UC Irvine policies. His academic department would then have decided how much to keep and how much to return to him. That didn’t happen. From 2014 to 2018, Hermanowicz didn’t report any payments from pharmaceutical companies on his annual “outside professional activity” forms, which ProPublica obtained through a public records request.

[…]

Approved in 2016, the drug, better known by its trade name, Nuplazid, has been associated with more than 2,000 patient deaths and 10,000 other adverse events, according to FDA data — figures that one expert has called an “important warning signal.” But for Hermanowicz, those concerns were overblown.

Nuplazid “got some attention in CNN recently with maybe an increasing risk of death, which I don’t think is valid,” he told the crowd. “They didn’t really do a careful analysis. They just said people took this medication and then they died.”

When Hermanowicz first connected with Acadia, as early as 2012, it was a relatively unknown firm, with no drugs on the market. But biotech insiders had high hopes for the company, which for over a decade had been developing Nuplazid to treat severe psychosis associated with Parkinson’s.

Hermanowicz became one of the drug’s primary advocates. Besides serving as an investigator in the trials, he also published several studies on its safety and efficacy.

In August 2015, he co-wrote an Acadia-funded study in the American Journal of Managed Care on how to manage the symptoms of Parkinson’s disease, emphasizing the need for effective treatment options. The next year, a study that he co-wrote called the drug “an important advancement” and a “first choice for treatment of Parkinson’s disease psychosis,” and he said it had a “better safety profile than current treatments.” In both studies, Hermanowicz disclosed his ties to Acadia.

The FDA’s clinical review reached a different conclusion. Conducted in 2016 by Dr. Paul Andreason, it found an increased risk of harm and death. Nuplazid failed two clinical trials, and patients experienced double the rate of adverse events of those on a placebo. Based on reviews of similar drugs, Andreason determined that Nuplazid’s safety profile was “not adequately safe” for treating Parkinson’s-related psychosis.

“We needed more controlled trial data to identify what the risk was,” said Andreason, who has since left the FDA.

When Nuplazid came before the FDA’s approval committee, Hermanowicz testified at the meeting, expressing the hope that the drug “will be available to me to provide to my patients.” In the company’s press release celebrating the approval, Hermanowicz said he was “delighted.” He was the only nonemployee quoted.

After Nuplazid hit the market, reports of deaths associated with the drug surged. “It’s a very high number” of deaths, said Diana Zuckerman, president of the National Center for Health Research. While it’s difficult to determine why there are so many fatalities, she said, the drug’s benefit isn’t worth the risk. In hundreds of cases, patients’ hallucinations, which are supposed to subside with the drug, were instead aggravated.

“This is not a particularly effective drug,” she said. “So what is the risk you are going to take?”

Last year, an FDA analysis found no “new or unexpected” safety risks related to Nuplazid. Acadia has maintained that the drug is safe for patients, and that the multitude of adverse events reflects its patient population, which is mostly elderly and in an advanced stage of Parkinson’s disease. “Our top priority is patient safety and we stand by the established efficacy and safety of Nuplazid,” said Maurissa Messier, a senior director for corporate communications at Acadia, in an emailed statement. Acadia is now seeking approval for Nuplazid to treat the millions of people who suffer from dementia-related psychosis, such as Alzheimer’s disease.

Hermanowicz has continued to publish studies supporting Nuplazid, lead medical education courses sponsored by Acadia and receive large consulting payments from the drugmaker without disclosing them to the university.

Some faculty members do take pains to comply with the university’s policy on outside income. Dr. Anjay Rastogi, a professor and clinical chief of nephrology at UCLA medical school, meticulously tracks all payments he receives from industry in a centralized spreadsheet — and remits the required portion, which he said funds academic enrichment, teaching or research.

“We need to disclose everything, I disclose more rather than less,” he said. “In my opinion, it’s fair that we help the university, and they help us as well.”

Read original story here.

Not Just Blowing Water — Vaping Presentation Will Sort Myth and Reality


“We keep calling it vaping, and calling it vapor,” Amy Osterman said. “But it’s an aerosol. It’s more like hairspray.”

That’s an image Osterman, youth marijuana and tobacco prevention coordinator for Walla Walla County’s Department of Community Health, likes to share with parents and teens.

Osterman is one of a trio of specialists presenting a vaping prevention and education night for parents and young adults on Monday.

[…]

Vaping, for anyone who has somehow missed all the talk, is equated with the electronic cigarette trend. According to the Centers for Disease Control and Prevention, a host of names are affiliated with the subject, including vape pens, vapes, tank systems and e-hookahs.

At their core, e-cigs produce an aerosol by heating a liquid that usually contains nicotine — the addictive drug in traditional cigarettes, cigars and other tobacco products — plus flavorings and other chemicals that help to make the aerosol.

Users inhale this aerosol into their lungs, but bystanders can also breathe in this aerosol when the user exhales into the air, according to the CDC.

Vaping is not safe for teens, kids and young adults, the federal agency has decreed.

School districts nationwide have been caught flat-footed and struggle to banish vaping on campuses, said Diana Zuckerman, author and president of the National Center for Health Research.

The devices used can be as small as a USB drive or a pen. Since there is no smoke, vaping at school can be virtually undetectable, Osterman said.

“That’s one of the challenges.”

Data is showing 31% of the teens who vape have transitioned to smoking regular cigarettes within six months, Zuckerman recently said in a session for education journalists.

CDC officials have been on the front lines of a sweeping, multi-state outbreak of lung injury associated with vaping.

As of Nov. 20, nearly 3,000 cases of e-cigarette, or vaping-associated lung injuries have been reported to CDC from 49 states (Alaska has not reported any cases), Washington, D.C., Puerto Rico and the U.S. Virgin Islands.

Forty-seven deaths have been confirmed, two of those in Oregon, and more are being investigated.

According to the CDC, analysis of fluid samples collected from the lungs of patients with e-cigarette or vaping-associated lung injury identified vitamin E acetate, an additive in some THC-containing vaping fluid.

Recent CDC laboratory test results of lung fluid samples from 29 patients from 10 states found vitamin E acetate in all of the samples, THC in 82% of the samples and nicotine in 62% of the samples.

Officials have said these findings are the first time they have detected a chemical of concern in biological samples from patients with these lung injuries, and that the latest national and state findings suggest THC-containing vaping products — particularly from informal sources like friends, family or dealers online or in-person — are linked to most of the cases and play a major role in the outbreak.

Those being hospitalized are often normally healthy kids, Zuckerman said, including the high school athletes “who will never be able to play their sport again.”

Even with awareness rising, 66% of teens believe vape fluid is simply flavoring, she said.

“We know (traditional) smoking is dangerous, but that’s 20, 30, 40 years down the road. But vaping is hospitalizing kids. It’s an unprecedented epidemic.”

Osterman agrees, noting Washington’s number of kids using vape products lines up with national rates. On the most recent Healthy Youth Survey taken by Washington’s Department of Health, 21% of 10th-graders and 30% of 12th-graders reporting vaping in the 30 days prior to the survey.

“Youth of all kinds are vaping. It’s not the troubled kids, but the kids on the honor roll at Wa-Hi,” she said.

Her department works with schools across the county, and none are immune to this issue.

[…]

Read original story here.

How Minnesota Schools are Doubling Down on Anti-vaping Efforts

Erin Hinrichs, MinnPost: December 2, 2019


As teen vaping rates continue to rise, Minnesota educators are monitoring their classrooms and hallways for well-disguised vaping devices.

Some are shaped like USB flash drives that students can charge by plugging them in to their laptop. Others double as pens and highlighters. Some are even less conspicuous: shaped like a smart watch, an ID badge attachment and even a replacement hoodie string.

What started out as a fad marketed to youth as a safer, healthier alternative to smoking cigarettes has ballooned into a health epidemic that public health officials and politicians are scrambling to rein in. As of Nov. 20, the Centers for Disease Control and Prevention (CDC) says 2,290 injuries and 47 deaths have been reported as a result of using e-cigarette or vaping products. Teens and young adults make up the bulk of those vaping-related hospitalizations resulting from serious lung damage, says Diana Zuckerman, president of the National Center for Health Research.

“I just want to emphasize how serious this is,” she told education reporters during a recent webinar hosted by the Education Writers Association. “When we think about smoking, we know it’s dangerous 20, 30, 40 years down the road. The fact that we already have so many kids hospitalized from vaping is just an unprecedented kind of epidemic.”

Armed with this new health information, administrators and educators at many metro area schools are doubling down on their anti-vaping efforts. While the bulk of their focus remains on getting information to students and parents, many are expanding the scope of their educational outreach and shifting from a punitive disciplinary approach to one that takes a more holistic approach.

[…]

A less punitive approach

Likewise, in the Rosemount-Apple Valley-Eagan district, health staff are looking at ways to build out a more holistic approach to dealing with vaping in schools — a less punitive approach that’s better fit to address any related mental health issues.

Deb Mehr, the district’s health services coordinator, says the district recently received a grant from the county that will be used to accomplish two key things: add vaping information to the curriculum and support diversion efforts that keeps kids in school and connect them with resources to make healthier decisions.

Addressing misperceptions about the health risks associated with vaping, she says, are paramount. And it’s hard to have engaging conversations with youth when they’re too fearful of disciplinary action to seek information or help.

Her sense of urgency around addressing vaping is spurred by two recent seizure episodes at two different school sites — once this year and once last year. In other instances, she’s found students who’ve been vaping experience very high blood pressure and pulse rates.

“I think part of the problem is kids don’t know what they’re vaping,” she said.

Health officials have linked recent vaping-related lung injuries to THC and vitamin E oil, mostly found in illegal vaping products. But even legal ingredients — like nicotine and formaldehyde — are “potential carcinogens and very toxic” says Zuckerman. And manufacturers aren’t required to list all of the ingredients, since they’re considered trade secrets.

Along these lines, teaching students to be more critical consumers is key to keeping them safe, says Leslie Stunkard, a licensed drug and alcohol counselor in the Minneapolis Public Schools district.

With more than 70 schools districtwide, she says the push from her team has really been to teach students, especially the older ones, to be “skeptical about the advertising they hear.” She likes to point out how these companies are trying to market themselves as a good thing — by offering scholarships and even selling vitamins.

Offering another example of how educators in her district are getting students to think more critically about vaping, she says a science teacher at Washburn High School has created a lesson on vaping that explains the how even the name “vaping” is deceiving.

“I think one of the things that slowed us down a bit is the staff are learning — just as we and the students are learning — just how dangerous it is,” she said.

Read the original article here