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Concerns That Public Hearings on Breast Implants Will Favor Implant Manufacturers

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

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

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.”  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

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

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.”

In April, the F.D.A. announced it was investigating Juul’s marketing practices to determine if the company deliberately targeted youths. The agency requested reams of documents from the company, including focus group reports and toxicology studies. Juul has submitted thousands of pages of records to the agency, but neither the F.D.A. nor Juul have made them public. Dr. Gottlieb said the agency’s tobacco division is still poring through them.

While the actions against the industry are alarming to the e-cigarette companies, they are also problematic for the F.D.A.

In July 2017, as part of a broad plan to reduce tobacco deaths in the United States, the F.D.A. extended the deadline for e-cigarette makers to comply with new tough federal guidelines, which, among other things, require companies to prove the e-cigarettes are beneficial to public health. In granting the five-year extension till 2022, Dr. Gottlieb said he would also force manufacturers to cut nicotine levels in traditional cigarettes, to render them nonaddictive. For that to work, he said, smokers needed more and better cigarette substitutes.

But in an interview, Dr. Gottlieb said the immense popularity of vaping among teens and the growing addiction among young people was not something he foresaw last summer, and the agency must rethink its policy — perhaps moving the deadline closer and requiring companies to gain F.D.A. approval to stay on the shelves.

Risa Robinson, a professor of mechanical engineering at Rochester Institute of Technology, began studying e-cigarettes six years ago for the F.D.A. The early products did not have enough nicotine to cause concern, she said. But later products, like Juul, had more nicotine and, she said, can become even stronger depending on how deeply a user puffs.

“I’m highly concerned now,” Dr. Robinson said. Beyond nicotine, the addition of heat to the e-liquid flavors generates chemicals that have not yet been studied in depth, she added.

The attorney general of Massachusetts, Maura Healey, who recently began an investigation into the marketing and sale of e-cigarettes to minors, praised the F.D.A.’s action.

“We’ve worked too hard over the past 50 years to reduce smoking rates among young people to let these companies profit off of getting them hooked on nicotine,” Ms. Healey said. “This move by the F.D.A. is a good first step to shut down companies targeting minors.”

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)

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. 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]

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.  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.

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

FDA Rarely Uses Its Power to Recall Dangerous Medical Devices. Why Not?

Meg Bryant, MedTech Dive: August 31, 2018.


The FDA has the authority to recall dangerous and risky medical devices, but it has rarely done so, largely relying on manufacturers to take necessary actions when a product defect or spike in serious adverse incidents occurs.

Since Congress passed the medical device amendments to the Food, Drug & Cosmetics Act in 1976, the agency has used its 518(e) mandatory recall authority just a handful of times. In 1991, the FDA ordered Medline to recall its Dynafeed enteral pump due to design flaws and failure to comply with good manufacturing practices. The agency issued three mandatory recall notices the following year and in 2008, recalled Nebion’s MRI device, citing lack of FDA approval and safety and effectiveness data, as well as noncompliance with GMPs.

There have been some recalls under federal consent orders, and the FDA has in four cases taken the unusual step of banning a medical device. The first time was in 1983 when it banned prosthetic hair fibers used to treat baldness because of serious risks including infections. Then in 2016, the agency simultaneously banned powdered surgeon gloves, powdered patient examination gloves and absorbable power used for lubricating surgeons’ gloves. The danger: Residue from the powder could be left behind in the body cavity, causing inflammation and scarring that could lead to complications later on. In addition, bits of latex from the gloves could bind the powder and be inhaled, putting people with latex allergies at risk.

Given Bayer’s recent decision to stop selling the Essure birth control device, following years of unmitigated safety concerns and mounting patient lawsuits, and the release of the Netflix documentary, The Bleeding Edge, many are questioning why the FDA seems so reluctant to wield its recall authority.

“The FDA has not taken them off the market, has not rescinded approval for specific uses, has not done a mandatory recall and has tried to put out [a] warning that the agency knows is not going to be effective,” said Diana Zuckerman, president of the National Center for Health Research. “They do that all the time.”

‘Insurmountable threshold’

“Once products are on the market, it’s almost an insurmountable threshold to get the agency to take action to pull them from the market,” said Michael Carome, director of Public Citizen’s Health Research Group. “In the case of [Bayer’s] Essure, had the company not voluntarily acted, I suspect FDA would not have pushed them to pull it from the market, based on statements they made over the last few years in the face of concerns.”

Approved in 2002, Essure was associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes and migration of the device into the pelvis or abdomen. The FDA required the addition of a boxed warning and patient decision checklist to the product’s labeling and in April restricted sales of Essure, but did not call for its withdrawal from the market.

That’s not unusual, says Jodi Scott, partner in Hogan Lovells’ Denver office and former FDA counsel. “By and large companies are pretty responsive to a very direct FDA request to take action,” she tol MedTech Dive. “And while I’m sure it doesn’t work in 100% of the cases, I will tell you it probably works 99% of the time.”

Mandatory recalls are also costly for FDA to take. According to the agency, the estimated annual reporting burden associated with section 518 actions is 1,098 hours.

As a last resort, FDA will order a recall, but it’s a lot easier to “look the company in the eye and tell them we think you need to do a recall and have them do it voluntarily,” Scott said. “And it happens much faster. To go to court and get an order takes a lot of time.”

It can also take time to sort out signals detected through the agency’s MDR reporting and Sentinel systems. If officials think there is an imminent risk of harm, they will do an analysis to determine whether the company needs to take some field action, which may or may not involve a recall. “You have to balance the risk and benefits,” Scott said, noting implants are often left in place and monitored when issues arise because of the risks associated with taking them out.

Still, she insists FDA “is not shy” about telling companies when reparative actions fall short and they need to do more. “But it’s all sort of informal, not invoking the mandatory recall authority,” she added.

Problem begins in premarket process

Critics say the real problem precedes FDA’s failure to act once a device is on the market and lies with the process used to bring most moderate and high-risk devices to market. Under the 510(k) premarket notification, companies need only to demonstrate that a device is substantially similar to another product in the market in terms of its intended uses and technological features. In most cases, no clinical trials are required.

Even when clinical trials are required for novel devices subject to premarket approval, they aren’t always randomized. And in cases where devices are given conditional approval and required to undergo postmark testing, the FDA is often lax about seeing that companies complete studies in a timely manner, they argue.

“They allow these studies to drag on for years and years and years, and by the time the studies are done, or if they are ever done, nobody needs the information anyway anymore because the product’s not on the market anymore or the product has changed so much that the information you have about the product that was being sold three years ago is not relevant to the product being sold today,” Zuckerman said.

Zuckerman pointed to the case of breast implants. The FDA approved two silicone gel-filled breast implants in 2006, with the proviso the manufacturers — Johnson & Johnson’s Mentor and Allergan — each would study 40,000 women for 10 years. Neither completed the studies, which involved cumbersome online questionnaires and did not provide any incentives for women to complete them. 

Too close to industry?

“Ultimately, the agency is too industry-friendly,” Carome told MedTech Dive. “They view the industry as a partner rather than a regulated entity.” He believes the adoption of user fees has made the situation worse by allowing industry to negotiate benchmarks for FDA product reviews and other activities in return for payments for reviewing product submissions and other services.

Meanwhile, a 2016 proposal to ban electrical stimulation devices intended to treat people with mental or behavioral disorder that who exhibit self-injurious or aggressive behavior has yet to be finalized.

At the time of the proposed ban, only one facility in the U.S. was using the devices: the Judge Rotenberg Educational Center in Canton, Massachusetts. “Our primary concern is the safety and well-being of the individuals who are exposed to these devices,” William Maisel, chief scientist and deputy director science at CDRH, said at the time. “These devices are dangerous and a risk to the public health — and we believe they should not be used.”

No one is arguing the FDA should recall or ban every device that poses an imminent risk of harm, Zuckerman said. But in cases where FDA opts to keep a product on the market despite well-known risks, it should use the powers it has to require timely and well-designed studies that demonstrate safety and effectiveness versus available alternatives. The agency should “use the teeth it has,” she argued. […]

Read original article here.

Does Infrared Light Therapy Work for Weight Reduction?

Danielle Pavliv, Sandy Wang and Varuna Srinivasan, National Center for Health Research


Wouldn’t it be great if we could each shed a couple of inches off our waist without having to diet or exercise?  For years, millions of Americans have tried pills, injections, “natural” herbs, and even berries that are supposed to help us shed pounds.  Unfortunately, these usually don’t work.

The latest magical way to lose weight is infrared light, also known as “red light therapy” or “low light therapy”

Infrared therapy is also suggested for pain management, jaundice, eczema, wrinkles, scars, improved blood circulation, and to help wound and burns heal faster. That doesn’t mean it actually works for any of those things. But in this article, we’re focusing on whether it works to help you look thinner. 1

Light therapy uses near infrared light, usually from lasers, lamps, or tanning bed-like devices. The patient is told to either lie down or sit in front of the light for a specific amount of time on a regular basis (usually once a day). One popular device is the infrared body wrap, consisting of large silicone bandages or pads that emit infrared light around the legs, torso and arms. In addition, patients are told that red light therapy is supposed to improve the appearance of cellulite and help shape the body.

If it sounds too good to be true, it probably is. There is little scientific evidence supporting the claims that infrared light, whether administered by lamp, laser or while in a body wrap, can help people lose weight or shape their body. Nevertheless, in 2010, the FDA cleared a laser called Zerona, manufactured by Erchonia Medical Inc., which uses red light therapy to remove “unwanted” fat without surgical procedures. This device is not approved by the FDA – it is “cleared for market”, which is a different process that does not require that a device be proven safe or effective.  Since 2010, several devices using the same technology have been cleared for marketing in the U.S. for body contouring and fat reduction. 2

Light therapy has been tested in clinical trials of patients, but these studies were not as scientific as they would need to be to prove safety or effectiveness. Most studies have few patients who have very similar demographics. Since the patients and clinicians know that the patient is being treated, and in most studies the patients getting treatment weren’t compared to patients getting a different treatment, this could result in a type of “placebo effect.” The placebo effect is when patients believe in a treatment and for that reason it seems to help even if the treatment isn’t actually effective. Also, the companies that make the light therapy devices provided funding to conduct the studies, which can result in overly optimistic results.

Despite all these substantial shortcomings, the studies showed only a small benefit from the light therapy.  So, even if the treatment has some benefit, which is doubtful, the benefit may not be substantial enough to be worth the time and money for the treatment.

In addition, all of the studies were short – none were more than 4 months long, and none followed up with the patients for more than a few weeks after treatment. So, we cannot know how long even small changes might last or what might happen if patients continued the treatment for years.

And what about the risks? Almost all of the studies did not provide any information about potential side effects of the therapy. However, one study done in Poland looked at the effects of LLLT used in close contact with the skin.  They found that patients developed skin ulcers as a result of certain types of lasers. 3

What exactly do the studies show?

A study funded by Erchonia (the company that makes Zerona) included 54 overweight or obese patients.4 Most of the patients were Caucasian men which is odd, since most weight loss patients are women. The patients were treated weekly for 6 weeks. The study found a significant reduction in the combined circumference of hips, waist, thighs, and upper abdomen by 13 cm (about 5 inches) after 6 weeks. Two weeks after the final treatment, patients lost another 2 cm (about 0.8 inches). However, patients knew that they were getting this treatment and may have changed their diet or exercise in an effort to succeed. These patients were not compared to a control group, so we can’t tell how much patients would have changed without the treatment. Also, patients were only studied for two weeks after their last treatment, so we do know how long this reduction lasted.

Whether or not infrared therapy is effective on its own, some scientists are studying whether it can potentially boost the benefits of exercise. To do this, they study obese patients all of whom are in an exercise program. Half the patients also get light therapy and the other half don’t. Results in these studies show us that it is possible that infrared therapy boosts the effect of exercise on weight loss. However, the studies were not well designed so it is impossible to know.

 A study in Brazil tested whether LLLT and aerobic exercise could reduce the chances of obese women developing heart disease.5 It was a well-designed study: 62 women were given an exercise regimen and randomly assigned to either be exposed to LLLT or a placebo for 4 months. LLLT increased the effectiveness of aerobic exercise to improve the women’s heart health. The scientists reported that LLLT reduced the abdominal fat and the women’s total body fat as measured by waist circumference and other measures. However, the study did not follow the women after their 4 months of treatment, so we don’t know how long the effect lasted.

Another device using Water Filtered Infrared Radiation (known as wIRA) is currently being studied to see if it helps patients lose weight.6 In this study, all 40 patients engaged in aerobic exercise 3 times a week for 4 weeks, with some patients also treated with wIRA while exercising. Although they were able to show a statistical difference in weight loss between the two groups (p<0.001), there were so few people in the study to be certain, and not enough information about any benefits lasting more than 4 weeks.

The uses of wIRA are currently being studied for a variety of medical conditions.7,8 However, there are currently not enough studies to conclude how effective it is for weight loss.

Bottom Line

Light therapy may possibly reduce fat in the short term, but studies are small and only follow patients for a few weeks or months. We don’t know if any likely benefit is large enough to be meaningful or how long it might last.  So, if you want to lose weight, sustain weight loss, and get fit, we suggest exercise and dieting in a healthy manner. These tried and tested methods are also shown to decrease the overall risk for heart disease and some cancers in the long term.

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

References:

  1. LED light therapy accelerated healing pain reduction red near infrared. (2015). Retrieved fromhttps://www.elixa.com/light/healing.htm
  2. Accessdata.fda.gov. (2018). 510(k) Premarket Notification. [online] Available at:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
  3. Jankowski M, Gawrych M, Adamska U, Ciescinski J, Serafin Z, Czajkowski R. Low-level laser therapy (LLLT) does not reduce subcutaneous adipose tissue by local adipocyte injury but rather by modulation of systemic lipid metabolism. Lasers in Medical Science. 2017;32(2):475-479. doi:10.1007/s10103-016-2021-9.
  4. Thornfeldt CR, Thaxton PM, Hornfeldt CS. A Six-week Low-level Laser Therapy Protocol is Effective for Reducing Waist, Hip, Thigh, and Upper Abdomen Circumference. The Journal of Clinical and Aesthetic Dermatology. 2016;9(6):31-35.
  5. Duarte FO, Sene-Fiorese M, de Aquino Junior AE et al (2015) Can low-level laser therapy (LLLT) associated with an aerobic plus resistance training change the cardiometabolic risk in obese women? A placebo-controlled clinical trial. J Photochem Photobiol B 153:103–110. https://doi.org/10.1016/j.jphotobiol.2015.08.026
  6. Möckel F, Hoffmann G, Obermüller R, Drobnik W, Schmitz G. Influence of water-filtered infrared-A (wIRA) on reduction of local fat and body weight by physical exercise. GMS German Medical Science. 2006;4:Doc05.
  7. Hoffmann G. Principles and working mechanisms of water-filtered infrared-A (wIRA) in relation to wound healing. GMS Krankenhaushygiene Interdisziplinar. 2007;2(2):Doc54.
  8. Al-Ahmad A, Bucher M, Anderson AC, et al. Antimicrobial Photoinactivation Using Visible Light Plus Water-Filtered Infrared-A (VIS + wIRA) Alters In Situ Oral Biofilms. Hamblin M, ed. PLoS ONE. 2015;10(7):e0132107. doi:10.1371/journal.pone.0132107.

New Drugs So Pricey They Need New Payment Plans

Sarah Owermogle, Politico: August 13, 2018.


[…] FDA LOOKS TO MODERNIZE CANCER TRIALS — The FDA issued guidance on Friday intended to speed up certain early and mid-stage clinical trials for oncology drugs by merging elements typically found in phase 1 and phase 2 trials. Studying multiple patient groups separately for criteria like safety and efficacy has the potential to lower costs and add efficiency, Commissioner Scott Gottlieb said in a statement.

Initial reviews were positive: “There is no tablet that got handed down from God to Moses that said drug trials must be conducted in three conventional phases,” said Dana-Farber’s George Demetri, who chairs the American Association for Cancer Research’s government affairs committee. The new approach, known as expanded cohort trials, could allow researchers to be more nimble, Demetri said — more easily spotting a drug’s effect on specific cancers or realizing earlier that it isn’t working.

Vanessa Lucey said the Cancer Research Institute, where she directs the venture fund and clinical accelerator, has itself moved toward these kinds of studies.

The costs: But while the proposed changes could streamline certain cancer trials — the guidance is limited to cases in which a drug’s benefits justify an increased risk, like for cancers that have no cure — there still could be additional costs. In the guidance, the FDA warned that trial sponsors would need to streamline logistics and data collection, and incorporate plans to assess data in real time.

“What’s important about this guidance is it’s trying to come to some kind of political compromise,” said Diana Zuckerman, president of the National Center for Health Research. “It’s trying to do two things that usually conflict — speed and safety don’t go together, usually.” She added: “It’s OK to say they’re going to do this to speed up drug development, but some patients are definitely going to get harmed.” […]

Read the full story here.

NCHR Testimony of TIRF REMS

Stephanie Fox-Rawlings, National Center for Health Research: August 3, 2018


Thank you for the opportunity 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.

Our Center worked with Congress to create the REMS [risk evaluation and mitigation strategy] program in legislation that became law quite a few years ago.  The goal always was to enable FDA to approve effective drugs even if they had worrisome risks. The REMS were intended to lower those risks as much as possible, so that patients taking the drug were most likely to be helped and least likely to be harmed.

A major shortcoming of these risk mitigation strategies has always been ensuring that they are effective in lowering risks.  It is difficult to evaluate the effects of the REMS on prescribers, pharmacists, patients, and others who accidentally or intentionally misuse the drugs.

The data before you today that evaluated these REMS are limited.  However, we commend the efforts of TRIG [TIRF REMS Industry Group] and the FDA to assess these REMS and to improve the data as well as the effectiveness of these REMS. We strongly urge that TRIG implements the FDA recommendations in a timely and complete manner to more fully understand to what extent the REMS are or are not working, so that they can increase the benefit to risk ratio of their products.

The data are especially limited regarding the proportion of prescriptions for cancer pain or other indications.  That is a big problem since this product is only approved for cancer pain.

And, also like the FDA reviewers, we are very concerned about the increased rate of adverse events after implementing REMS.  Even though the reports are voluntary and therefore could be biased, the increase after REMS is very disturbing. The quality of the REMS data are also low because only a subset of potential events are evaluated.  This makes the data very difficult to interpret. However, other sources of data also suggest that there are concerning numbers of therapeutic errors, misuse and exposures with severe consequences.

Congress supported REMS because they were intended to reduce the risk of serious harms, while continuing to make the product available to those who need it. The data indicate that these REMS need improvements. For example:

  • 42% of new users were not opioid-tolerant. That is not the indication, so that means at least 42% are prescribed off label.  This increases the risk for central nervous system and breathing problems.
  • Relatively high proportion of survey respondents did not know the correct indication or that TIRFs need to be stopped if around-the-clock opioid medication is stopped.  They learned this in the training, but could not remember it when surveyed later.

Changes to the REMS should be designed to make them more effective at protecting patients. Changes in REMS should not be aimed primarily at increasing the number of prescriptions.  An increase in prescriptions without ensuring appropriate prescribing, dispensing, use, and disposal increases the risk that more patients will be harmed, and that the drugs will be used accidentally or misused by individuals who were not prescribed the drug.

Bottom line: TIRFs [transmucosal immediate-release fentanyl] provide important options for cancer patients dealing with pain. However, we all know that they carry very serious risks and that’s why we need REMS that protect patients’ these risks.  These REMS are not working as well as the should to protect patients and need to be improved.