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Patient Advocacy Workshop 2016

Patient Advocates Wanted!

Researchers in government and at universities are listening to patients’ perspectives on the risks and benefits of treatments. They need to hear from patients like you! That’s why we are holding several free workshops for individuals who want to be advocates for patients. The Workshops will train patients and family members to understand research that evaluates the safety and effectiveness of treatments and prevention strategies, and teach them about opportunities to share their own views and perspectives in ways that will most benefit patients.

Most patient advocates help a small number of individual patients. Our goal is different. Our workshops and training are designed to help patient advocates get the information, skills, ad confidence they would need to help patients on a national level by influencing the development and evaluation of treatments used by patients across the country.

You might be surprised to learn that many studies of new treatments measure changes that do not necessarily improve patients’ health or quality of life. For example, it is faster and less expensive to study whether a cancer drug shrinks tumors than to study whether that same drug helps a patient live longer or have a better quality of life. Some patients might be fine with taking a chance on a drug that is not proven to help them live longer, because they have run out of options. Others only want to try a new drug if it is likely to help them live longer or have fewer side effects. Those kinds of patient perspectives are very important to researchers and to health professionals, and we will help patients have the expertise they need to share their views with researchers and opinion leaders.

Our next workshop will be held on Friday October 14 and Saturday October 15, 2016. The 2-day workshop will be free, and meals will also be included. Hotel rooms and travel scholarships to Washington, DC will be available for those who live at least 40 miles away.

Anyone can apply, but we are especially interested in adults who have previously been involved in patient advocacy, either as an individual or as a member, volunteer, or staff for a nonprofit organization or government agency.

Please complete our application at http://goo.gl/forms/CxFrg61Qk15pxvyw1. Preference will be given to applications received by July 31, 2016. And feel free to share with other patients who are well enough to advocate for themselves and others.

Make your voice heard! 

Find out more about this year’s Patient Advocacy Workshop HERE.

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Patient advocate Diana Levine discusses her experiences, at the June 12, 2014 Workshop

Is bigger better? Mentor receives FDA approval to conduct clinical trials for larger breast implants

Farzana Akkas, MSc. and Diana Zuckerman, PhD

Recently, Mentor, a company that makes breast implants, received FDA approval to initiate clinical trials to study the safety and effectiveness of their new and larger memory gel breast implants. Mentor’s memory gel implants are made of an outer silicone shell, filled with clear silicone gel. The largest implants currently available in the U.S. are 800cc, which is about the size of a cantaloupe. The study is enrolling mastectomy patients starting in April 2016 and will evaluate the safety of implants that range in size from 750cc to 1,445cc.

Although silicone gel breast implants have been sold in the U.S. since the 1960’s, they were not approved by the FDA until 20061, after taking them off the market for cosmetic patients in 1992 due to safety concerns. The approval in 2006 was based on research done by breast implant manufacturers such as Mentor and INAMED (a company that was sold to Allergan). Since the approval, all breast implants have been found to increase the chances of developing a rare form of lymphoma (cancer of the immune system) known as anaplastic large cell lymphoma (ALCL). 2

Although research linking systemic health consequences and silicone breast implants gives conflicting results, local complications such as rupture, pain, capsular contracture, disfigurement and infection are an obvious complication from breast implants.  Capsular contracture is the most common complication of breast implant surgery, followed by hematoma (blood clot), infection and pain.3, 4 Rupture is considered inevitable if the woman doesn’t replace aging implants.5 The FDA advises women to undergo breast coil MRI tests to check for rupture of silicone gel breast implants starting 3 years after surgery and every 2 years after that.6 This is because most silicone gel breast implants do not show any signs of rupture for several years (this is also known as silent rupture). However, breast coil MRIs are expensive and not usually covered by health insurance.7, 8

The concern about larger silicone gel breast implants, such as the ones being tested by Mentor, is that an enormous amount of silicone could leak into the woman’s body if the implant ruptures. Mentor justifies that larger implants are necessary because larger breasted women who have been diagnosed with breast cancer need them to be consistent with their normal breast size.

As obesity has become more common, more mastectomy patients have requested larger breast implants  It is particularly likely because women who are overweight are more likely to develop breast cancer. However, they are also more likely to have a recurrence of breast cancer.  For that reason, obese women who have had breast cancer should be helped to lose weight in order to lower their chances of breast cancer coming back after the surgery.  Replacing a woman’s breast with a very large implant could encourage her to remain overweight, rather than to lose weight.

If these larger breast implants are approved, however, some women who have never had a mastectomy might choose them for cosmetic reasons.  This would be especially dangerous because research shows that breast implants can interfere with breast cancer screening mammography and mammography can cause breast implants to rupture.9

The bottom line is that there are still many unanswered questions and conflicting studies on the safety of breast implants. Being able to offer a better size range to larger breasted mastectomy patients certainly does not adequately justify the need for larger breast implants when the negative health consequences are considered. It is important to continue conducting unbiased research to study the complications of breast implants and how implant manufacturers can improve the integrity of their implants to avoid or decrease incidents of complications.

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 •??? ????? ????? ?????? ??? ???????? ?? ??? ???? ???? ?? ??? ???? ???? ????? ???? ????? ???? ?? ??­????? ?? ????? ??????? ? ????? 20 ????? ????? ????. ???????? ??????? ?? ?? ????? ??? ??­???? ?? ????? ?????? ???? ?????? ?????? ???? ??? ???? ?????? ?? ????? ????.

 

 • ??????? ????? ???????????? ?? ?????­??? ?????? ?? ???? ????? ? ????? ???? ??? ???????­??? ???? ? ?????? ????????? ?? ??? ??????? ??? 18 ??? ???? ?????? ???????? ????? ?????­ ???????? ?????.

 

 • ????? ?????? ?????? ??? ? ????? ?????? (FDA) ???????­??? ???? ?? ???????? ?? ???? ???? ????­??? 21 ???? ? ??? ?? ? ? ???????­??? ???? ?????? ?? ???? ????­??? 18 ???? ? ??? ??  ????? ???? ???? ??????? ??????? ?????? ???? ??? ????? ???? ????? .?????­? ?????? ??????? ?????? ?? ???? ???? ?? ????? ???? ???? ???? ???? ???? ?????? ??? 18 ??? ????? ??? ?? ??? ??? ??? ???? ???? ?????? ?? ???? ?????. ?????­? ?????? ?????? ??? ???? ???? ???? ?? ???? ?????? ?????? ??????? ?? ???? ???? ???? ???? ???? ???????? ????? ????? ???.

 

 •??????? ???? ???? ?? ?? ???? ???? ????­??? ???????? ??????? ????? ???????? ?? ?? ??? ? ????? ??? ?????- ? ??? ???????? ?? ?????? ?? ???? ??­????. ?? ????? ?????? ??? ????? ??? ?? ??? ?????? ? ????? 11 ?? 18 ???? ???? ???? ?? ????? ?? ????? ???? ??? ?? 18 ????? ???? ???? ???? ?????? ? ????? ?????? ???.?? ????? ????? ???????? ?????? ?? ?????? ?? ????­ ?????  ????? ????? ???? ?? ??? ??? ?????. ??? ????? ?????? ???? ???? ?? ????? ???????? ???? ??????? ?? ???? ?????­??? ????? ?? ???? ????? ???? ?????­??? ?????? ?? ??? ????? ??? ?? ??????? ????? ?? ? ??????? ??­???.

 

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??? ???­?????? ?? ????? ????? ???????­??? ???? ?? ????? ????. ????? ?? ???????­??? ???? ?????? ????? 7 ?? 10 ??? ???? ??­?????? ??­?????? ????? ????? ?? ?? ???? ????? ????. ??? ??? ?? ????­?? ?? ?? ??? ?????? ???? ????? ?? ??? ??? ?????? ??? ?????? ????? ?????? ??? ??????? ?? ?? ????? ???? ?????? ?????? ????? ? ?? ???? ???? ????? ???.explanted

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?????? ?????? ??? ? ????? ?????? FDA ???????­??? ???? ?? ???????? ?? ????? ???? ??? ??? ???? ???? ????­???? ?? 22 ??? ? ????? ?? ????? ? ????? ??????­??? ??? ?? ???? ????? ?????FDA ?? ???? ?????? ?? ??? ???? ??????? ???? ?? ????? ??­???? ?????? ??? ?? ?? ??? ??? ?? 80000 ????? ?? ?????? ???? ????? ??? ?? ??? 10 ??? ????? ????

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??? ???? ???? ??? ?? ????? ????? ?? ? ??? ???? ? ???? ?????? ????.

FDA ???????­??? ???? ????? ??? ???? 2 ???????­? Inamed(?????? McGhon ?? Allegan ??? ?????? ?????)?Mentor ?? ????? ???? ???.?? ????? ?? ???????­??? ???????? ??? FDA ????? ?? ?? ???? ??? ????? Silimed ?? ????? ???? ???.???? ???????­??? ???? ???????? ???? ????? ???????? ???????­??? ???? ????? ??? ???? ?????? ???? ????? ?????? ???? ?????? ???? ? ???? ???? ?? ????? ????? ??? ?????? ???.??? ??? ???????­??? ???? ???? ????­?? ?? ????­??? ????? ?? ?????­?????????? ????? ???? ? ?????? ??????? ????? ????? ???

FDA ????? ???? ?? ???????­??? ???? ???? ???? ????­?? “???? ????? ???” ????? ??? ?? ???? ???? ?? ????? ?? ????? ???? ???? ??????? ???? ???.

“???? ????? ???”?? ???? ??? ???? ????? ???? .FDA ??? ???? ?? ?? ???? ??????? ???? ???????­ ???? ??? ??? 3 ??? ??? ?? ???? ???????­ ?????? ?? ???????? ????? ?? ?????­? ??? ?? ???? ??? ?? ???? ???? ????.

??? ??????? 10 ?????????? ????? ?????? ?????? ?? ?????? ?? ???? ??? ?? ??? 10 ??? ???? ?? ?? ???? ???????­ ???? ??????? ????? ?????.???????? ????? ????? ????? ???? ???? ???? ?? ??????? ?? ???? ?? ??? ???? ? ???? ??? ?? ??? ?????? ??????

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??? ????????? ???????­??? ??? ???? ? ???? ?? ????? ?????? ????? ?? ???? ??? ???? ????? ???? ?????? ? ?????? ????? ?????.???????? ?????Capsular Contraction ?? ?????? ?????? ??? ?? ????? ????? ????? ?? ???? ??? ???? ??? ??? ???? ???????­ ??? ?????.??? ??­????? ???? ??? ???????­ ?? ????? ??? ? ?????? ????? ???? ?? ??? ???? ?? ??? ????? ???? ???.????? ?? ?? ??? ?? ??? ??? ???? ? ??? ????? ?????.

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?????? ?? ??????? ????? ?????? ???? ?? ??? 5 ??? ??? ?? ?????? ???????­??? ???? ??????? ?? ????? ????? ?????.?? ??? 10 ?? 12 ??? ????? ?????? ?? ????? ?? ????? ????? ? ???? ?? 2 ????? ????? ?? ????? ?????? ?????? ????.

????? ??? ?? ??? ??????? ?? ??? ?? ????????(??????? ???? ?? ????? ?? ??) ???????­ ???? ????? ??? ?????????.?? ?? 10 ???? ????? ??? ?? ???????­ ???? ?4??? ?? ?? ????? ????? ?? ??? 3 ??? ?????? ?????.

??? ??? ?? ????? ??? ?? ????? ??? ?????? ??????? ??? ???? ?? ???????­ ???? ???? ??? ?? ??????? ??? ???? ????? ??? ?????? ????? ??????? ???.??? ???? ?????? ??? ???? ?????? ?????? ???? ??? ??? ??????? ???? ???????­ ???? ?? ?? ????? ?? ?? ????? ?? ?????? ??? ????? ???? ?? ????? ????????.

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??????????? ?? ???????? ???????­?? ?????? ?????? ????.?? ????? ???? ????????? FDA ??? ???? ?? ?? ?? ??? ?????????? ?? ???? ??? 10 ??? ?? ????? ???? ???????­ ???? ??????????? ??? ?? ???? ????? ??? ?? ????? ???? ???.

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???? ???????­?? ?? ????? ???? ????? ?????. ???????­?? ?? ?? ???? ????????  ????? ???­??? ?? ???? ??(??????? ???? ??????? ?? ?????) ?? ??????.????? ??? ?????????? ???????­?? ???????? ?? ????? ?? ????? ?? ????? ????.?? ?? ????? ?? ????? ???? ???? ?? ??????? ???? ?????? ?????.

????­?? ???????? ?? ????? ?? ???? ?? ??? ???????­ ?? ????? ???? ???? ?? ???? ?? ???? ????? ???? ?????­??? ?? ?? ????? ????? ?? ????.?????­?? ? ?????­?? ??­?????? ????? ??? ?? ???????­?? ???? ?????? ?????? ????? ????? ?????? ???????? ??? ?? ????? ?? ???? ?? ??? ???? ???? ??? ????­? ??? ??? ?? ?????? ???????­?? ?? ????.

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Angelina Jolie’s Decision

by Diana Zuckerman, PhD, president of the Cancer Prevention and Treatment Fund

Huffington Post, May 16, 2013

 

When I read about Angelina Jolie’s announcement this week, I cringed.

I have greatly admired her willingness to speak out on important issues over the years. Her public announcement about her mastectomies will certainly reassure some women that losing a breast to breast cancer isn’t quite as frightening as it had once seemed. But Ms. Jolie is a powerful role model to millions of women. What are the unintended consequences of the role she is modeling regarding breast cancer?

Is breast cancer so frightening that it is better for a woman to remove her breasts before she is even diagnosed? Obviously, that isn’t what Ms. Jolie is saying. She has one of the breast cancer genes (BRCA1), and that greatly increases her chances of getting breast cancer.

However, the extremely high risk that she quoted from her doctor (87 percent chance of getting breast cancer) was based on old, small studies. Newer studies have found that the risk of getting breast cancer for an average woman with BRCA1 is 65 percent. Since being overweight and smoking increase the risk and exercising and breastfeeding lower the risk, Ms. Jolie’s risk of breast cancer, even with the BRCA1 gene, could be considerably lower.

Of course, the lifetime risk of breast cancer would still be high, but it wouldn’t be nearly as high a risk during the next 10 years or even 20 years. According to experts, a 40-year-old woman with the BRCA1 gene has a 16 percent chance of getting breast cancer before she turns 50. That’s not nearly as frightening, and with regular screening and all the progress in breast cancer treatments, the survival rate from breast cancer is higher than ever. Many breast cancer patients live long and healthy lives. And, it is possible that by the time Ms. Jolie (or any other woman with BRCA1) got breast cancer in the future–if she ever did–the treatments available would be even more effective than they are today.

Thanks to mammograms, women are getting diagnosed with breast cancer at much earlier stages, making it safe to undergo a lumpectomy (which removes just the cancer) rather than a mastectomy (which removes the entire breast). And yet, American women are undergoing mastectomies at a higher rate than women in other countries–many of them medically unnecessary. Breast cancer experts believe that many women undergoing mastectomies don’t need them and are getting them out of fear, not because of the real risks.

As an actress whose appeal has focused on her beauty, surgically removing both her breasts when she didn’t have cancer was a very gutsy thing to do. But if we care about women’s health, we need to stop thinking of mastectomy as the “brave” choice and understand that the risks and benefits of mastectomy are different for every woman with cancer or the risk of cancer. In breast cancer, any reasonable treatment choice is the brave choice.

Nobody can second-guess Angelina Jolie’s choice–it’s hers alone to make. Fortunately for her, she has access to the best reconstructive surgeons in the country, and they will keep her breasts looking as natural and beautiful as possible, an advantage that most implant patients don’t have. If she has any of the common problems with her breast implants, she can afford to get those problems surgically fixed whenever she wants to. She can also afford breast MRIs every other year ($2,000 each), which the Food and Drug Administration recommends as a way to make sure that the silicone from the implants is not leaking into the lymph nodes.

Angelina Jolie is not in any way an average woman, and what felt right for Angelina Jolie might not be right for most women who are afraid of getting breast cancer, and not even for most women with the BRCA1 or BRCA2 gene.

I thank Ms. Jolie for speaking up about her decision, and I thank the many cancer experts who are doing their best this week to explain why double mastectomies are not the best choice for most women. Let’s use this teachable moment to have a frank discussion of the treatment choices for breast cancer and to encourage women to make decisions based on their own situations, not on the choice of a celebrity, however admirable she is. For each woman, it’s important to weigh her own risk of cancer–in the next few years, and not just over her lifetime–and the risks of various treatments, and to make the decision that is best for her.

Public Health Implications of Differences in US and European Union Regulatory Policies for Breast Implants

Reproductive Health Matters, December 2012
By Diana Zuckerman, PhD, Nyedra Booker, PharmD, MPH, and Sonia Nagda, MD, MPH

Tens of thousands of defective silicone breast implants were recalled in Europe in 2011–12 soon after the FDA’s unrelated announcement that a rare cancer of the immune system was associated with all saline and silicone gel breast implants. These developments raised questions about whether U.S. and European regulations were protecting patients from unsafe medical implants.

In the US, breast implants are regulated as high-risk medical devices that must be proven reasonably safe and effective in clinical trials and subject to government inspection before they can be sold. In contrast, clinical trials and inspections have not been required for breast implants or other implanted devices in Europe. As a result of these differing standards, the PIP breast implants that were recalled across Europe had been removed from the market years earlier in the US. Nevertheless, the FDA track record on breast implants indicates that studies have provided limited information about safety.

The authors conclude that neither the European Union nor the US has used their regulatory authority to ensure the long-term safety of breast implants. However, in 2012 the EU announced regulatory changes that could improve that situation.

To see the official summary: http://www.ncbi.nlm.nih.gov/pubmed/23245415