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What Health Care Coverage Under the Affordable Care Act Means to You

Cost, news-you-can-use

What Health Care Coverage Under the Affordable Care Act Means to You

If you are thinking about enrolling for health care coverage for 2019, you have from November 1-December 15, 2018 to apply through Open Enrollment.  Here’s what you need to know about what it will pay for:

  •  Doctor’s visits—Doctor’s visits and outpatient surgery or procedures that do not take place in a hospital;
  • Trips to the emergency room—the average cost can be more than an average month’s rent;
  • Treatment in the hospital for inpatient care.  If not insured, an average three-day stay can cost $30,000;
  • Care before and after a baby is born— prenatal care, labor and delivery costs tens of thousands of dollars.  A C-section alone can cost $50,000;
  • Mental health and substance use disorder services, which include treatment, counseling, and psychotherapy;
  • Your prescription drugs—almost half of all Americans took at least one prescription drug in the last 30 days;
  • Services and devices to help you recover from injury or to help with disabilities or chronic conditions. This includes physical and occupational therapy, speech therapy, and psychiatric rehabilitation;
  • Lab tests, whether complicated or simple blood tests;
  • Preventive services can include counseling, cancer screenings, and vaccines to keep you healthy; and
  • Pediatric services including dental care and vision care for children.

 

For more information about how to sign up for health insurance through Open Enrollment under the ACA, see our article here.

NCHR Testimony to the FDA Patient Engagement Advisory Committee on Medical Devices

Policy, Testimony & Briefings

National Center for Health Research: November 15, 2018.

Good morning.  I’m Jack Mitchell, and while I’m with the National Center for Health Research, today I’m speaking on behalf of members of the Patient, Consumer and Public Health Coalition, an informal consortium of about two dozen public health and non-profit organizations which work together on policy and legislative issues.  I have no financial conflicts of interest.

We thank FDA for holding this meeting and for exploring these important patient-centric issues.  We appreciate Dr. Shuren and senior CDRH officials giving presentations on their latest efforts to enhance patient engagement and post-market surveillance and safety, which are primary areas of concern for our non-profit organizations.

As we’ve heard, social media, when utilized properly, can be a highly useful source of shared information for patients.  The independent USA Patient Network has reported to us that their members regularly use social media to communicate about drug and medical device safety and treatment issues; and to report device-related adverse events to FDA

However, concerns remain, especially when social media are used to collect data.  Patients have reported to us that industry-sponsored social media patient platforms can influence discussions in ways that are not always in patients’ interest.  For example, a recent news story in Stat News of the Boston Globe revealed how patients and non-patients alike can earn money as so-called “influencers”, to provide opinions or promotions on the Internet about medical devices and drugs.  In fact, there are a few companies which act as talent recruiters for such influencers, and facilitate their communications with device and drug companies.

These influencers can be paid for posting about a device or drug, or for bringing opinions of people like them to the companies which are developing these medical products.  Industry companies have paid fees and travel expenses for some of these influencers to sit in on sponsored patient engagement meetings. The companies also gain insights into the patients from these interactions.

Some regard this activity as a form of relatively inexpensive advertising for industry, and often there is not much, if any, transparency concerning exactly who the influencer might be representing or being paid by.  The Federal Trade Commission has cited influencers who fail to reveal that they are being paid for an endorsement of a device or drug. There are a lot of confusing ethical thickets to wade through with these kinds of social media influencing.

There’s certainly nothing wrong with the industry trying to gain insights into its potential patients and customers.  But members of our Coalition, and the USA Patient Network, represent independent, non-sponsored patient voices who wish to gain helpful information on their conditions from FDA and other legitimate medical sources, and that is why we are concerned about hidden commercial influences on social media.  The patient groups which we work with also would prefer a balanced approach to reporting: adverse events should be clearly reported in social media, not just positive experiences.

Along those lines, USA Patient Network members have told us that the very helpful MedWatcher app has recently not been functioning properly, a complaint you have also heard from another speaker today.  When the MedWatcher app was functioning properly, patients were able to report and edit their adverse events to FDA.

These same patients have used Facebook, Twitter, Instagram, and other social media to report problems with the birth control device Essure, vaginal mesh, hip implants, breast implants, and other medical device issues.  That type of interactive communication, which was not technologically possible a decade or so ago, is a critically important tool for patients who sometimes mistakenly feel they are the only person with their particular type of medical condition.  On social media they learn that there is a community of patients just like them who can share information, do research, and suggest qualified medical professionals to consult.

Social media can serve as an invaluable, interactive forum both for patients and the FDA, provided that some of the financial and ethical conflicts that can arise from their use does not interfere with patients’ ability to access accurate and unbiased medical information.

Thanks to the Committee for the opportunity to speak today.

NCHR Testimony on the Opioid Buprenorphine/Samidorphan for Depression

Policy, Testimony & Briefings

Stephanie Fox-Rawlings, PhD, National Center for Health Research: November 1, 2018

Thank you for the chance to speak today on behalf of the National Center for Health Research. I am Dr. Stephanie Fox-Rawlings. Our Center analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug and medical device companies, so I have no conflicts of interest.

As we’ve heard today, depression is a serious health issue. However, FDA approval requires proof that new drugs are safe and effective. New drugs have to work to help patients.

I’ll focus on efficacy first. The evidence presented for buprenorphine/samidorphan (BUP/SAM) does not provide adequate evidence that it reduces depression more than placebo.

Two of the three trials designed to provide evidence of efficacy did not find any statistical benefit of the drug compared to placebo. The third trial, study 207, had a statistically significant reduction in depression on the MADRS for the 2mg/2mg dose. However, this trial also has major shortcomings. For example, it used the MADRS-6, which lacks important aspects of depression and therefore can’t prove efficacy.

Using the full MADRS, the only time the drug is more effective than placebo is for just a few weeks in the middle of a short trial. By the end of the trial, the placebo group was doing as well as the treatment group. This does not demonstrate a meaningful benefit for patients. And though statistically significant for that short time, treated patients improved less than 2 points more than placebo on a 60 point scale. This difference seems too small to be clinically meaningful for patients.

MADRS has clear standards for improvement. “Responders” are defined as those whose symptoms improve by at least 50%. Remission is defined by those scores are 10 or below on MADRS. Patients taking the drug were not more likely to be a responder or go into remission than patients taking placebo for any of the efficacy trials. This again raises questions about whether the benefit in study 207 is clinically meaningful compared to studies of other antidepressants. These trials may just be too short, but there needs to be confirmatory evidence that the statistically significant result is real.

Study 202 was designed as a proof of concept study and FDA points out that it can’t prove efficacy because it lacks the statistical controls to make sure that the difference did not occur by chance. Also, the relatively high dropout rate for patients in the drug arms could have a large effect on the results. We agree with the FDA reviewers that the lack of a dose response also raises red flags. If the drug is effective, the high dose (8mg/8mg) should at least show a statistical trend toward significance. It doesn’t.

As we all know, in studies of depression the placebo groups often do quite well. Placebo controls are essential because they help control for the natural ebb and flow of depression episodes. Instead, the sponsor tries to eliminate evidence of the placebo effect. Without the trial-long comparison of the placebo to drug arms, it is not possible to determine whether natural fluctuations in depression or the treatment are affecting the results.

There are concerns about safety.

The clinical trials included very few older patients. Older patients metabolize drugs more slowly and are more likely to have adverse reactions. They are also likely to be taking many other drugs that could interact with this drug.

Like all opioids, even ones with abuse-deterrent properties, this drug has the potential for misuse and abuse. This is a major concern because depressed patients are more likely to have substance abuse disorders and are at increased risk for opioid overdose.

In summary, the clinical trial data do not provide adequate evidence that BUP/SAM reduces the symptoms of depression. There are concerns about it potential for long-term harms to patients and others who might misuse or abuse it. BUP/SAM needs to provide strong evidence of efficacy before approval.

Although refractory depression is a serious condition, prescribing a treatment with unproven benefits and unknown risks is very dangerous. And, as you know, new drugs for depression tend to be more widely prescribed than the narrow indications that FDA approves. Approving this drug even for refractory depression could easily contribute greatly to our current opioid epidemic.

 

The joint Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted against approval (21 against and 2 for).

NCHR Testimony on the Opioid Sufentanil

Policy, Testimony & Briefings

Varuna Srinivasan MBBS MPH, National Center for Health Research: October 12, 2018

Thank you for the opportunity to speak today. My name is Dr. Varuna Srinivasan. I am a physician with a Master of Public Health from Johns Hopkins University. I am a Senior Fellow at the National Center for Health Research, which analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug and medical device companies, so I have no conflicts of interest.

We have strong concerns about the safety of the drug in question today: Sufentanil.

First, we are concerned that the level of pain relief provided by sufentanil is not clinically meaningful. Patients taking the drug had statistically lower levels of pain than patients taking placebo based on their SPID score, but this difference was so small I would not consider it helpful to my patients. Just as important, there was no difference in how long it took for patients to experience “meaningful pain relief” between placebo and this drug that is supposedly five times more potent than fentanyl! If it was really more effective than placebo, surely it would work more quickly to relieve pain.

The weak results are even more problematic because there was only one pivotal phase 3 clinical trial. We have an opioid epidemic and it is crucial that the FDA not approve opioids that are not proven to work.

There is limited diversity in the clinical trials. Most of the study patients were white and younger. We would assume that a wide variety of patients visit the ER or undergo surgery, but that diversity of demographic background is not reflected in the study population. In fact, the FDA memorandum provides is no information on any racial and ethnic subgroups. They combined trials where they gave 15mcg and 30 mcg to different patients. These have different profiles but they controlled by the study sites and FDA finds it to be relevant. While there are no older patients in the trial with 30mcg, they are extrapolating the safety data as a whole and the mean age for the trial with 15 mcg is 58 so keeping this in mind, how do I phrase this sentence – The sponsor also failed to look at older patients, even though we know that pain tends to increase with age..

In summary, this drug is not proven to have a meaningful impact on reducing pain in post-operative settings. I respectfully urge you to let the FDA know that the agency should require better evidence of the efficacy of this drug. The sponsor should submit more conclusive data to this advisory committee before it can consider recommending approval for sufentanil.

On October 12th, the advisory committee voted 10-3 in favor of approving Sufentanil

 

Concerns That Public Hearings on Breast Implants Will Favor Implant Manufacturers

In the News, News Stories & Editorials

Kris Pickel, CBS News: October 4, 2018.

PHOENIX (3TV/CBS 5) — The Food and Drug Administration has agreed to hold a public hearing on Breast Implant Illness. It’s a victory for women who petitioned the FDA but CBS 5 is investigating concerns the hearings will be stacked to favor implant manufacturers.

Breast Implant Illness (BII) is not recognized as a medical condition.

It is a term used by thousands of women to describe a wide range of unexplained symptoms experienced by women who believe their implants made them sick.

Symptoms of Implant Illness

 

 

 

 

 

 

 

 

 

 

CBS 5 has been investigating BII for almost two years and has seen the number of women coming forward increase by the tens of thousands.

When our first investigation aired, the Facebook group Breast Implant Illness and Healing with Nicole, had 17,000 members. It now has more than 51,000.

News reports and social media are connecting women who believe they suffer from BII.

They are finding strength in numbers.

More than 21,000 women signed an online petition demanding the FDA hold public hearings.

The FDA agreed to meet privately with a small group of women who believe they suffer from BII.

Among the women who traveled to the District of Columbia for the September meeting at FDA headquarters were breast cancer survivors, women who believe implants made them sick, experts on breast implants and women who recently played a role in having the birth-control device Essure pulled off the market.

Women in the group say the FDA set the terms for the meeting: No cameras, no recording, no reporters allowed.

Following the September meeting, the FDA released a statementdisputing a study linking implants to illnesses.

Buried at the end of the statement, the FDA announced they would hold a public hearing on breast implants next year.

Nicole Daruda founded the website HealingBreastImplantIllness.com and the closed Facebook group Breast Implant Illness and Healing with Nicole.

Daruda say some of the issues they want to address include taking textured implants the FDA has said might be linked to the potential for a rare cancer off the market, comprehensive studies and requiring surgeons to give women a checklist of potential risks at least a week before surgery.

In the FDA’s public hearing, an advisory panel will hear from industry representatives, experts, women who believe their implants made them sick and members from the public.

Following the public hearing, that advisory panel will vote on recommendations to make to the FDA. The panel does not have the power to make changes. It will only make recommendations.

Dr. Diana Zuckerman on CBS News

Dr. Diana Zuckerman is president of the National Center for Health Research in D.C. and is responsible for a dozen Congressional investigations on a various health issues.

Zuckerman says in the past, the FDA has stacked the panels with plastic surgeons who have a financial interest in protecting breast implants. 

“Having surgeons whose entire livelihood, or almost entire livelihood, is based on breast surgery, with breast implants, can’t possibly be objective,” Zuckerman said.

She says she has witnessed multiple times where plastic surgeons advocate for implants and dominate the hearings.

“I’ve seen situations where a statistician, for example, says, ‘Look at how unsafe these products are,’ and the plastic surgeon says, ‘No. No. No. We put these in all the time and they are very safe.'”

We contacted the FDA a several times during this investigation and asked if they would be looking at the panel to eliminate possible conflicts of interest.

They responded with a link to their application for panel members, which includes a section that addresses conflict of interest.

Conflict of Interest

The FDA website lists the core group of eight voting members on the advisory panel.

CBS 5 was able to confirm at least two of the doctors perform breast implant surgeries and a regulatory expert who previously worked for Johnson & Johnson, which owns implant manufacturer Mentor.

Zuckerman says in the interest of ensuring an unbiased panel, people should contact their elected officials in Washington and ask them to  pressure the FDA to make sure no one with financial ties to the implant industry sits on the advisory panel.

One Woman’s Story

Robin Towt shares her story

Cancer survivor Robyn Towt was in the group of women who met with the FDA.

When diagnosed with breast cancer, Towt immediately opted for a double mastectomy.

She says her health issues, including anxiety and insomnia, started the day her implants were put in.

Having survived cancer before, radiation was not an option.

Towt chose not to do chemotherapy, leaving no explanation as to why she was getting sicker.

“I have been never been that miserable in my entire life and in that dark a place,” she said. “I feel horrible because my family suffered. My husband suffered. I was not a happy person. I was not a healthy person. I had no quality of life. I was desperate. I was sleep deprived.”

Towt says a friend in a cancer support group suggested she look into her implants as a source for her health problems.

After connecting with women on social media, Towt had her implants removed just four months after having them put in.

She says her symptoms disappeared within 48 hours.

CBS 5 Investigates has uncovered that while implant manufacturers are required to publish informational booklets that include warnings on potential risks of implants, plastic surgeons are not required to give the booklets to women.

Towt says after her implants were removed, she went back and asked her surgeon for the booklet so she could compare the warnings to the consent forms she signed.

Towt says the warnings in the booklet were stronger when it came to certain risks, including cancer associated with breast implants.

“I kind of felt duped when I was comparing them because if I had read the information in that booklet to start with, I would have never ever considered it,” she said.

Towt’s plastic surgeon did not return calls to CBS 5 inquiring when the booklets are provided to patients.

A date for the FDA’s public hearing has not been set.

The FDA says it will happen sometime in 2019.

 

Read the original article and watch the news segment here.

How to Report Problems With Medical Products to the FDA

General Treatment Issues, Quality Of LIfe, Treatment & Management

National Center for Health Research.

Every year, tens of thousands of consumers suspect that their medicines or medical devices might be causing unexpected side effects. Side effects – also called adverse reactions – can be quite minor, such as a rash or stomach upset, or very serious, such as mental confusion, heart damage or an autoimmune reaction. It is sometimes difficult to tell if the health problem is caused by the medical product or is merely a coincidence. That is why serious problems that are possibly related to a medical product should be reported to your physician and to the Food and Drug Administration (FDA). You do not have to be certain that the health problem is caused by the medical product – the purpose of a tracking program is to figure out if there is a problem by looking for a pattern in the reports. By tracking these reports, the FDA can determine if there is a pattern that may indicate the need to warn consumers or even to withdraw a product from the market.

The FDA has a program called MedWatch for reporting serious reactions and problems with medical products, including drugs and implanted devices.

The process is relatively simple and is outlined on the MedWatch website. You may ask your doctor to fill out a MedWatch form detailing the problem you have been experiencing. The MedWatch form is available online or you or your doctor can request a copy of the form by calling the FDA toll free at 1-888-INFO-FDA (1-888-463-6332).

If for some reason you do not wish to have the form filled out by your doctor or your doctor refuses to fill out the form (doctors are not required by law to complete a report to the FDA), then you can complete the form yourself. MedWatch provides a set of instructions for completing the form on their website, as well as an online form that you can submit on the website.

If you prefer to report your problem over the telephone, you can do that by calling the at 1-800-FDA-1088.

If you have questions or comments about a specific drug or medical device, you can call the FDA toll free information number at 1-888-INFO-FDA (1-888-463-6332), press 2, followed by 1 for information, then:

  • for dietary supplements, press 2
  • for drug products, press 3
  • for medical devices, press 4
  • for biologics, including human cells, tissues and cellular and tissue-based products, press 6

Reporting problems helps fix them and ensure that other patients do not experience the same unexpected side effects or reactions.

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

Summary of Published Study by MD Anderson Physicians on the Increase in Rare Diseases Among Women with Breast Implants

Breast Cancer, Breast Cancer, New Cancer Research

National Center for Health Research: September 17, 2018.

A study published in September 2018 in the medical journal Annals of Surgery, entitled US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients, concluded that “silicone implants are associated with an increased risk of certain rare harms” and that further study is needed “to inform patient and surgeon decision-making.” Also, the study was published on social networks and became more visible with many subscribers and comments which were provided by The Marketing Heaven. The study is important because it is largest study to date, but it has limitations because it is based on data from flawed studies conducted by two implant companies, Mentor and Allergan.

The data collected from the two studies were supposed to be very similar, but because of how poorly the studies were conducted, they are not comparable.  Mentor’s data are focused on patients’ self-reporting on questionnaires, primarily on data of only 20% of the patients collected 7 years after the study was started. Allergan’s data are based on physicians’ diagnoses during the first two years after the patients had implant surgery.  Since patients’ self-reports at 7 years would be expected to include more complications than physicians’ diagnoses after 2 years, it is impossible to make meaningful comparisons between the two manufacturers. Nevertheless, it is important to note that the MD Anderson researchers found that the risks of certain autoimmune diseases increased by 800% (Sjogren syndrome), 700% (scleroderma), and 600% (arthritis) for the women with Mentor silicone gel breast implants compared to the general population of women of the same age and demographics.  Stillbirths increased by 450% in the women who became pregnant.  Other autoimmune and rare diseases were also significantly higher among women with Mentor silicone gel implants.  These diagnoses were also statistically significantly higher (although not as dramatically increased) for women with Allergan implants compared to the general population of women of similar demographics. Given the large percentage of women who were not in the study for more than 1 year, it is not possible to know how representative these findings are. However, these results certainly deserve careful attention.

It is also important to note that the women with saline breast implants who were in the Mentor and Allergan studies were not analyzed in the MD Anderson study.

FDA Response

In response to this important study, Dr. Binita Ashar of the FDA published an editorial in the same issue of the same medical journal, claiming that the MD Anderson study “failed to account for methodologic differences between studies, inconsistencies in the data, differential loss to follow-up, confound and other potential sources of bias.”  That is true.  However, Dr. Ashar did not mention that the FDA should take responsibility for all the shortcomings of the data that MD Anderson analyzed.  She did not mention that the flawed data were based on studies that were required by the FDA as a condition of approval for the breast implants made by Allergan and Mentor.  The data were flawed because women soon disappeared from the study, and the FDA did not require the companies to finish the studies, as they should have,

As a result of the FDA’s failure to enforce the study requirements, the large Allergan and Mentor studies used as the basis of the MD Anderson analyses were very flawed short-term studies rather than the 10-year studies that FDA had proudly said they were requiring.  Whereas the companies blamed the study shortcomings on the enormous number of women who “dropped out” of the study shortly after enrolling (including 80% of the women with Mentor implants after only 1 year), we have interviewed women who were enrolled in those studies who told us that they did not drop out of the studies – rather they were “dropped” from the study by the researchers without their consent.  They never heard from the researchers and hence had no opportunity to tell the researchers how sick they had become after getting breast implants.   Instead, several of those women went to the FDA this month to explain to FDA scientists what happened.  They told Dr. Ashar and other FDA officials that they were dropped from the studies.  They told Dr. Ashar and other FDA officials that they had suffered from autoimmune and connective tissue symptoms such as the ones reported in the MD Anderson study.  They told Dr. Ashar and the other FDA officials that despite being sick for years, they were unaware that breast implants could be the cause because neither the FDA nor their plastic surgeons had warned them of the risks.  When they finally found each other on social media (on Facebook pages joined by more than 50,000 women harmed by breast implants), they realized that removing their implants might help.  Much to their surprise, they experienced almost miraculous recoveries after their implants were removed by experienced explant surgeons.   The women told Dr. Ashar and other FDA officials that their symptoms disappeared entirely or improved by 85%.

The FDA editorial was written before Dr. Ashar met with the former implant patients this month, but she had previously met with several of the same women who had reported these same problems and recoveries after explant surgery.  So it is very discouraging that FDA staff have been and continue to be so close-minded about the risk of breast implants despite the MD Anderson analyses.

What Have we Learned from the MD Anderson Study?

We agree with the FDA and the MD Anderson researchers that these results can’t be considered conclusive, but the FDA needs to look at the data more carefully and require better studies so that they can reconsider their repeated claim that breast implants are only proven to cause local complications, such as leaking and painful implants.  Although the FDA admits that breast implants can cause a cancer of the immune system known as ALCL, they continue to quote industry-funded studies claiming that implants do not cause other systemic illnesses.  It should be obvious to open-minded scientists that if breast implants can cause cancer of the immune system, they can probably cause other serious immune system diseases and symptoms.  Moreover, the results of the MD Anderson study supports those concerns about autoimmune symptoms and diseases.

What should be the key information of importance to women considering breast implants or women who have them in their bodies? Clearly, these studies indicate that patients should report any new symptoms that develop after getting their implants, whether involving their breasts or other parts of their body.  Breast implant patients should know that the FDA recommends MRI imaging of silicone breast implants 3 years after the augmentation or reconstructive surgery and every 2 years thereafter.

  

Statement of Dr. Diana Zuckerman, President of the National Center for Health Research Regarding the New Study of 100,000 Women with Breast Implants

Breast Cancer, Breast Cancer, In the News, Press Releases

Dr. Diana Zuckerman, President of the NCHR: September 17, 2018.

In the largest study ever conducted of long-term health risks for patients with breast implants, researchers at The University of Texas MD Anderson Cancer Center have reported that women with silicone implants are more likely to be diagnosed with several rare diseases, autoimmune disorders, and other conditions.  These results are consistent with numerous previously published studies, but contradict the conclusions of studies funded by implant manufacturers or plastic surgery medical societies.

The study, published in the medical journal Annals of Surgery, is by researchers in MD Anderson’s Department of Plastic Surgery and is based on analyses of almost 100,000 patients with either saline or silicone implants. The information was derived from the FDA’s database dating back to 2005.  When the FDA approved silicone gel breast implants made by two manufacturers in 2006, the agency required that each of the manufacturers study at least 40,000 women for 10 years.  Those studies were started but never completed, making it impossible to determine the long-term risks of breast implants.  In the absence of such crucial studies, patients report that they were not warned about the risks when they decided to get breast implants.

We thank Mark W. Clemens, M.D., associate professor, Plastic Surgery, the senior investigator of this very important study.  The findings are consistent with what thousands of women with breast implants have reported in Facebook groups and other social media, and directly challenge the FDA’s claims that breast implants do not cause such diseases.  We urge the FDA to be more patient-centered and finally require independent studies be conducted of women before and after their breast implants are removed.  Many women have reported that their debilitating autoimmune symptoms decreased or disappeared after their breast implants were removed, but scientific data is needed to establish the rate of recovery.

F.D.A. Targets Vaping, Alarmed by Teenage Use

In the News, News Stories & Editorials

Sheila Kaplan and Jan Hoffman, The New York Times: September 12, 2018.

WASHINGTON — The Food and Drug Administration on Wednesday declared that teenage use of electronic cigarettes has reached “an epidemic proportion,” and it put makers of the most popular devices on notice that they have just 60 days to prove they can keep their devices away from minors.

The order was part of a sweeping government action that targeted both makers and sellers of e-cigarettes. If Juul Labs and four other major manufacturers fail to halt sales to minors, the agency said, it could remove their flavored products from the market. It also raised the possibility of civil or criminal charges if companies are allowing bulk sales through their websites.

The agency said it was sending warning letters to 1,100 retailers — including 7-Eleven stores, Walgreens, Circle K convenience shops and Shell gas stations — and issued another 131 fines, ranging from $279 to $11,182, for selling e-cigarettes to minors.

Federal law prohibits selling e-cigarettes to anyone under 18. In a briefing with reporters, the F.D.A. commissioner, Dr. Scott Gottlieb, said that more than two million middle and high school students were regular users of e-cigarettes last year.

The government’s tactics underscore a dilemma in the public health community: In addressing one public health problem — cigarette smoking, which kills 480,000 people in the United States each year — e-cigarettes are creating another — hooking teenagers who have never smoked on nicotine.

E-cigarette users inhale far fewer toxic chemicals than do smokers of traditional cigarettes. But they can take in higher levels of nicotine, which is addictive.

“The developing adolescent brain is particularly vulnerable to addiction,” the F.D.A. said in its statement announcing the actions.

In particular, the agency has been watching the wildly popular Juul, which offers especially potent nicotine hits. Juul Labs launched the sleek device, which looks like a flash drive, in 2015. It comes with “pods” in eight flavors, among them mango, menthol and creme. In a short time, Juul has become the dominant seller of e-cigarettes and a fad among students. According to Nielsen data, Juul controls 72 percent of the market, and is valued by investors at $16 billion.

In an emailed statement, a Juul spokeswoman said: “Juul Labs will work proactively with F.D.A. in response to its request. We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people.”

Dr. Gottlieb said the F.D.A. would look closely at whether Juul and the other manufacturers were allowing bulk purchases of products through their own websites — a practice where the buyer could then sell to minors.

If such “straw sales” are happening, it should be readily apparent to the manufacturers, he said. “If the companies don’t know, or if they don’t want to know, we’ll now be helping to identify it for them.”

The other four products facing the 60-day deadline are RJR Vapor Co.’s Vuse, Imperial Brands’ blu and devices made by Logic. They said they were working with the F.D.A. as well.

RJR, Imperial and Altria are all major tobacco companies. As smoking rates have declined, the industry sees e-cigarettes as an important piece of its survival, a fact that makes some in public health mistrustful.

“They say they’ve changed from the days of Joe Camel,” Dr. Gottlieb said. “But look at what’s happening right now, on our watch and on their watch. They must demonstrate that they’re truly committed to keeping these new products out of the hands of kids.”

Dr. Gottlieb has said many times he believes that e-cigarettes and similar products known as electronic nicotine delivery systems may be effective options for adults who want to stop smoking but still crave nicotine. But he said teenage vaping has become so concerning that regulators may have to curb the availability of the devices to keep them out of the hands of youths.

“Inevitably what we are going to have to contemplate are actions that may narrow the off-ramp for adults who see e-cigarettes as a viable alternative to combustible tobacco in order to close the on ramp for kids,” Dr. Gottlieb said. “It’s an unfortunate trade-off.”

Dr. Gottlieb’s aggressive approach against private industry is unusual for an official in the business-friendly Trump administration which has sought to roll back numerous environmental and health regulations. But critics said that his decision last summer to extend a deadline for e-cigarette manufacturers to demonstrate that their products comply with public health concerns helped perpetuate the current problem.

“It’s nice they want to do something but realistically, what are they going to accomplish this way when they could be so much more effective by following the regulatory plan that had been ready to put into place and that the commissioner postponed?” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit health policy group.

She also pointed to the popularity of vaping among young adults. Researchers generally believe that the adolescent brain continues to develop through age 26. “It’s a big epidemic among people ages 18 to 30, too,” she said.

And while the F.D.A.’s announcement struck many as tough, legal experts said the agency could face a protracted legal fight if it follows through on its threats to ban flavors and curtail marketing.

Marc J. Scheineson, a health care lawyer and a former associate F.D.A. commissioner, said that the agency was relying on public opinion and its own bully pulpit to push the targeted manufacturers into “voluntary compliance.”

Some antismoking groups, while encouraged by the F.D.A.’s actions, expressed caution: “Asking the tobacco industry to come up with solutions is the proverbial case of asking the fox to guard the hen house,” said Robin Koval, the president and chief executive of Truth Initiative. “After decades, there is no evidence that the tobacco industry is able to regulate itself.” […]

A Juul spokeswoman, Victoria Davis, said recently that the company had already stepped up its own patrol of retailers who advertise to youths or who don’t enforce age requirements, as well as social media posts. But it’s not always easy.

From Jan. 1 through July 28, Ms. Davis said, Juul asked Instagram to remove over 5,500 posts, and the social media company complied on 4,562. Facebook Marketplace was less agreeable. The company agreed to remove 45 of 144 posts. Amazon took down 13 of 33.

Dr. Gottlieb said he was not impressed by the measures Juul and the other companies have taken.

“It didn’t have the intended impact or I wouldn’t be viewing the statistics I’m now seeing,” he said.

 

Read the original article here.

Radiation Therapy for Ductal Carcinoma In Situ (DCIS)

Breast Cancer, Breast Cancer, General Treatment Issues, Treatments that Cause Cancer

Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund.

In recent years, ductal carcinoma in situ (DCIS) has become one of the most commonly diagnosed breast conditions. It is often referred to as “stage zero breast cancer” or a “pre-cancer.” It is a non-invasive breast condition that is usually diagnosed on a mammogram when it is so small that it has not formed a lump. In DCIS, some of the cells lining the ducts (the parts of the breast that secrete milk) have developed abnormally, but the abnormality has not spread to other breast cells.

DCIS is not painful or dangerous, but it sometimes develops into breast cancer in the future if it is not treated. If it develops into breast cancer, it can spread.  If that happens, it is called invasive breast cancer. The goal of treating invasive cancer is to prevent it from spreading to the lungs, bones, brain, or other parts of the body, where it can be fatal. Since DCIS is not an invasive cancer, it is even less of a threat than Stage 1 or Stage 2 breast cancer, which are the earliest types of invasive cancer.1  For more information, see our free DCIS booklet, and our other articles on DCIS.

Most women with DCIS will never develop invasive cancer whether they are treated or not.  Unfortunately, it is impossible to predict which women with DCIS will develop cancer and which ones won’t. That’s why treatment is recommended. A woman with DCIS does not need all the same treatments as a woman diagnosed with invasive breast cancer, but surgery is almost always recommended, as is hormonal therapy (such as tamoxifen) if the DCIS is estrogen-receptor positive. Most DCIS patients will choose a lumpectomy (which removes the DCIS but does not remove the entire breast), and radiation therapy is usually recommended for those women to destroy any stray abnormal cells in the same breast.1  However recommendations for radiation therapy are changing.

Is Radiation Necessary?

Doctors usually recommend radiation therapy for lumpectomy patients, but since it is inconvenient and has some side effects, many women prefer to avoid it.  In fact, some DCIS patients decide to have a mastectomy because they do not want to undergo radiation.  However, mastectomy is a much more radical surgery and is very rarely a good idea for DCIS patients. That’s because almost all women with DCIS live long lives, and undergoing radiation does not affect whether DCIS patients live a long life or not.

Instead, the main advantage of radiation for DCIS is to prevent recurrence of DCIS in the breast where the DCIS was removed. A study of more than 1,700 women with DCIS who underwent a lumpectomy evaluated different treatment options.4  The women were randomly assigned either to radiation, tamoxifen, radiation plus tamoxifen, or no treatment after surgery.  Undergoing radiation had a very small benefit for women in general, and has little impact on your chances of living a cancer-free life.

In women treated with radiation, about 10% developed DCIS or breast cancer within the next 10 years after surgery, and it made no difference whether these women took tamoxifen or not. And while the vast majority of women were alive 10 years later, their chances of survival were no different whether they were treated with radiation, tamoxifen, both, or neither.4  

For women who did not have radiation therapy, tamoxifen reduced the chances of developing DCIS within 10 years in the same breast by about 3% and the chances of developing DCIS in the other breast by about 1%. Tamoxifen did not significantly decrease the chances of developing invasive breast cancer in the same breast, and only reduced the chances of developing invasive cancer in the opposite breast by about 1%.4

So why do doctors so strongly recommend radiation and hormone therapy for DCIS?  Doctors tend to focus on reducing “relative risk” rather than actual risk. So, if a  treatment decreases the chances of recurrence by about 50% that sounds impressive — but 50% of a 16% chance is 8%, for example, and that isn’t much of a difference. And 50% of a 6% chance of recurrence is even less meaningful.  Most important, it doesn’t affect survival so women can skip radiation now and choose it later if they have a recurrence. In contrast, if a woman has radiation after a lumpectomy and later has a recurrence anyway, she can’t undergo radiation again.

When is radiation most important for DCIS?  It is more likely to benefit younger women (especially women diagnosed before age 40), women with more serious types of DCIS (a high grade DCIS called comedo), and women with a family history of breast cancer.

The Van Nuys Prognostic Index incorporates four independent factors that predict local tumor recurrence (tumor sizes, margin width, pathology grade and necrosis, and patient age). Experts recommend that women with DCIS with a low score (4–6) on this Index should undergo a lumpectomy alone without radiotherapy since the chances of recurrence are low, and there is no evidence that radiation would reduce the chances of dying from breast cancer. 5

What is the benefit of hormone therapy for women also undergoing radiation therapy?

Tamoxifen blocks the effects of estrogen on breast cells, which can stop the growth of cancer cells that are sensitive to estrogen. A study of more than 1,800 pre-menopausal and post-menopausal women with DCIS evaluated the benefits of tamoxifen for women who had lumpectomy and radiation treatment. These women were randomly assigned to take tamoxifen for 5 years or a placebo (sugar pill). The study found that after 5 years, women who took tamoxifen were about 5% less likely to develop either DCIS or cancer in the same breast, cancer in the opposite breast, or distant cancer spread.  The difference was 8 of women taking tamoxifen compared to 13% of women taking placebo. However, the vast majority of women survived and they did not live any longer whether they took tamoxifen or not.1

For postmenopausal women, aromatase inhibitors may be used instead of tamoxifen. Aromatase inhibitors block the body’s ability to make estrogen. A study of more than 3,000 post-menopausal women with DCIS evaluated the benefits of hormone treatment for women who had lumpectomy and radiation treatment. These women were randomly assigned to take tamoxifen or anastrozole for 5 years. The study found that after 5 years, compared to women taking tamoxifen, the women taking anastrozole were 2% less likely to develop either DCIS or cancer in the same breast, cancer in the opposite breast, or distant cancer spread.  The difference was about 8% of women taking tamoxifen compared to 6% taking anastrozole.  As in the previous study, the vast majority of women survived and those taking anastrozole did not live any longer than women taking tamoxifen.2

That was a very small benefit for anastrozole compared to tamoxifen, and another study of post-menopausal women with DCIS found no difference between the two hormone treatments.3

Bottom Line:  Radiation and hormone therapy both have benefits for most women who undergo lumpectomy, because they decrease the chances of DCIS returning after surgery.  However, the benefits are quite modest and neither of these treatments affect how long women live, because almost all women diagnosed with DCIS are still alive 20 years later.

References:

  1. National Cancer Institute. Breast Cancer Treatment PDQ. (Feb. 2018). Available online: https://www.cancer.gov/types/breast/hp/breast-treatment-pdq#link/_1576_toc
  2. Margolese, Richard G et al. Anastrozole versus tamoxifen in postmenopausal women with ductal carcinoma in situ undergoing lumpectomy plus radiotherapy (NSABP B-35): a randomised, double-blind, phase 3 clinical trial.The Lancet. 2016;387(10021): 849 – 856.
  3. Forbes, John F et al. Anastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): a double-blind, randomised controlled trial. The Lancet.2016;387(10021): 866 – 873.
  4. Cuzick, Jack et al. Effect of tamoxifen and radiotherapy in women with locally excised ductal carcinoma in situ: long-term results from the UK/ANZ DCIS trial. The Lancet Oncology. 2011; 12(1): 21 – 29
  5. Wong JS, Kaelin CM, Troyan SL, et al. Prospective study of wide excision alone for ductal carcinoma in situ of the breast. J Clin Oncol. 2006;24:1031–1036.