Category Archives: Published Newspaper or Magazine Articles

Can California’s public universities mandate COVID-19 vaccines?

Robert M. Kaplan and Diana Zuckerman, Ph.D., Monterey Herald: April 26, 2021


Last week, the University of California and the California State University system proposed mandating COVID-19 vaccines for faculty, staff, and students beginning in the fall.  Only those with medical conditions aggravated by vaccination or those with legitimate religious objections would be excused.  The policy is consequential: Public university students, faculty and staff include nearly 1,000,000 Californians. But is the mandate feasible? And, should the California universities dive headfirst into what promises to be a complicated controversy?

With waning competition for shots, public health officials now worry about vaccine hesitancy. Lower vaccination rates give more opportunities for variants to develop and could make the pandemic last longer. We all benefit when more people are vaccinated.  Yet, national polls by Stanford and YouGov show that about 20% of Americans will refuse to be vaccinated, and one in three estimate their likelihood of getting vaccinated is below 50%. Only 20% strongly agree that vaccines should be mandated and 45% report that vaccinations should be strictly voluntary.

Requiring vaccinations may be legal. Since 1905, courts have consistently upheld vaccination mandates, but with some exemptions.  Although 50 states and Washington D.C. can require vaccines for primary schools, all states allow medical exemptions.  Further, 45 states permit religious exemptions and 15 recognize philosophical objections.  Only 16 states allow post-secondary institutions to require vaccinations for influenza or hepatitis B.

Despite these precedents, the UC/CSU proposal could be derailed because current CDC policy only allows mandates for vaccines approved by the Food and Drug Administration. Technically, no COVID vaccine is currently approved. Instead, the three vaccines have been authorized under a different vetting mechanism called Emergency Use Authorization.  Unlike FDA approval, EUA is a temporary agreement that allows medical products to be used in emergency situations based on FDA’s determination that the benefits “may” outweigh the risks.  That requires a less rigorous standard of evidence than FDA approval. Before the pandemic, EUAs were only used to speed emergency treatments to a relatively small number of people threatened by Ebola, Zika, and anthrax.

To be fair, each of the three authorized (but unapproved) COVID vaccines underwent rigorous testing in large studies. However, the FDA had announced that full approval of these vaccines would require following study participants for “at least one to two years.”  For the EUA’s,  FDA permitted just two months of follow-up and stated that while two months was the minimum to determine safety, it wasn’t sufficient to determine how long the vaccines would be effective.

With the EUAs in hand and bolstered by promising early results and extremely high demand for vaccines, companies had no incentive to continue the trials. Despite advice by scientists to continue studies with the inclusion of a control group, all three companies provided the vaccine to participants who had received a placebo. The ethical reasons for this are obvious; however, the consequence is that a rigorous evaluation of the long-term benefits and side effects is no longer possible in the absence of a placebo control group.

What do we know about safety?  137 million Americans have had at least one dose of the vaccine.  Although at least half have experienced bothersome reactions, very few have reported serious side effects that resulted in permanent damage or death. The FDA and CDC have two systems to track real-world reactions. V-SAFE is an app that regularly asks vaccinated individuals to report any health problems. Unfortunately, very few individuals use it.  The other system, the Vaccine Adverse Event Reporting System (VAERS) is designed for health care providers to report bad reactions to vaccines.   As with V-SAFE, reporting is not enforced and therefore reactions are under-reported.  The current systems are limited because they were not designed to accurately determine how many people experience adverse events.

UC/CSU should be commended for proposing a bold strategy to address a serious problem.  A mandate to vaccinate university communities could turn the campuses into COVID safe zones. However, it is likely to encounter serious legal challenges if none of the vaccines are FDA approved before the mandate is implemented. Instead of waiting for the FDA to deny approval for insufficient evidence, the UC and CSU systems could use their exceptional creativity and research capability to produce better evidence that would inform the FDA about the long-term scientific safety and effectiveness of the vaccines.

Robert M. Kaplan is a faculty member at Stanford University’s Clinical Excellence Research Center and a former Associate Director of the National Institutes of Health. Diana M. Zuckerman is the President of the Washington DC-based National Center for Health Research. She is an expert on the safety and effectiveness of medical products. You can view the original article here

Some textured implants have a cancer risk. Here’s why women are told not to remove them

Joce Sterman and Alex Brauer, WJLA: September 16, 2019.


WASHINGTON (SBG) – We’ve all heard of recalls on cars and dangerous toys, but a global recall of a device that’s surgically implanted inside your body has thousands of women on alert. The recall of Allergan’s textured BIOCELL breast implants was prompted by a government analysis that showed an increased risk of cancer. Still, women who have them are generally being told not to have them removed from their chests.

For the last two months, Raylene Hollrah’s email and phone have been blowing up, with hundreds of women contacting her non-profit, dedicated to raising awareness about the emerging cancer. It’s called Breast implant-associated anaplastic large cell lymphoma, also known as BIA-ALCL.

The fear women are dealing with comes following the August global recall of Allergan’s BIOCELL textured implants due to the increased the risk of lymphoma, a cancer of the immune system that Raylene now knows all too well.

When she was diagnosed with BIA-ALCL in 2013, it was a brutal double whammy. Hollrah had survived breast cancer and a mastectomy. During reconstructive surgery in 2008, she got the textured implants that eventually gave her cancer a second time, making her just the 25th documented case of BIA-ALCL in the United States at that time. Her treatment and the research that preceded it came courtesy of Dr. Mark Clemens, who is a pioneer when it comes to researching the disease at MD Anderson Cancer Center in Texas.

In 2017, our Sinclair station in Washington, WJLA/ABC7 was one of the first in the country to tell Raylene’s story and highlight the link between textured breast implants and lymphoma. In that report, reporter Kimberly Suiters pointed out the Food and Drug Administration was aware of 258 confirmed cases of BIA-ALCL. But she said the warnings were not making it to women who might be at risk.

When she was diagnosed with BIA-ALCL in 2013, it was a brutal double whammy. Hollrah had survived breast cancer and a mastectomy. During reconstructive surgery in 2008, she got the textured implants that eventually gave her cancer a second time, making her just the 25th documented case of BIA-ALCL in the United States at that time. Her treatment and the research that preceded it came courtesy of Dr. Mark Clemens, who is a pioneer when it comes to researching the disease at MD Anderson Cancer Center in Texas.

In 2017, our Sinclair station in Washington, WJLA/ABC7 was one of the first in the country to tell Raylene’s story and highlight the link between textured breast implants and lymphoma. In that report, reporter Kimberly Suiters pointed out the Food and Drug Administration was aware of 258 confirmed cases of BIA-ALCL. But she said the warnings were not making it to women who might be at risk.

Allergan voluntarily pulled the implants as well as its related tissue expanders from the market, but they remain in thousands of women, many of them breast cancer survivors. And while a letter obtained by Spotlight on America shows the company is offering free replacement implants, it won’t pay for revision surgery.

The letter explains the decision not to cover surgical fees is in line with an FDA recommendation that textured implants not be removed in patients who have shown no symptoms of BIA-ALCL. The FDA is telling doctors to stop using the implants but has told women they can keep the implants if they’re not symptomatic.

Diana Zuckerman with the National Center for Health Research says, “Some of the women are going to say I don’t care what the FDA says, I’m getting them out.”

Zuckerman explained the FDA’s advice to keep the implants balances the risks of surgery with the chances of getting this type of lymphoma, which is rare. BIA-ALCL is also highly treatable and Zuckerman says removing the implants before a woman is diagnosed with BIA-ALCL is not a 100% guarantee that she won’t develop the disease.

And there’s another big question following the recall: exactly who has these implants? Zuckerman says many women don’t know and may struggle to find out as doctors don’t have to keep these records permanently.

That’s a big deal considering it could take years for this kind of cancer to develop. For Raylene Hollrah, her BIA-ALCL diagnosis came five years after she had her implants placed. After cancer a second time, she had them removed permanently. Now Hollrah has become an advocate for women in this same situation, making sure they know about BIA-ALCL.

So far no one has firmly pinpointed why these implants are a cancer risk, although many theories exist. And while the recall right now is only for Allergan’s BIOCELL textured implants, the FDA said it, “will continue to evaluate any new information and may, as a result, take action regarding other breast implants, if warranted.”

[…]

Read the full article here.

Why Are So Many American Women Having Mastectomies?

Diana Zuckerman, PhD, and Megan Polanin, PhD, National Center for Health Research, Our Bodies Ourselves: June 15, 2017

When Angelina Jolie publicly announced her double mastectomy four years ago, she was praised for possibly saving many women’s lives. But we know more today than we did then and experts now agree that too many women are undergoing unnecessary mastectomies – even some women with the “breast cancer genes.”  You’ll be surprised by what we’ve learned.

A 2007 review of 10 studies found that the risk of getting breast cancer for an average woman with BRCA1 is 57%. The risk is 49% for a woman with BRCA2. Although frightening, this is far from the inevitable breast cancer diagnosis that many women expect. And, keep in mind that the lifetime risk of breast cancer is very different from the risk of getting breast cancer in the next 10 years or even 20 years. According to experts, a 40-year-old woman with the BRCA1 gene has a 14% chance of getting breast cancer before she turns 50. We’re willing to bet that is a much lower risk than most women assume. 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.

Most women are diagnosed with breast cancer at early stages, making it safe to undergo a lumpectomy (which removes just the cancer) rather than a mastectomy (which removes the entire breast). Yet American women are undergoing mastectomies at a higher rate than women in other countries, including prophylactic mastectomies. Breast cancer experts believe that many women undergoing mastectomies do not need them and are getting them out of fear, not because of the actual risks.

For many years, experts have known that women who undergo mastectomies for the non-invasive condition called ductal carcinoma in situ (DCIS) or for early-stage breast cancer do not live longer than women undergoing lumpectomies. However, the latest research goes a step further:  A 2016 study of more than 37,000 women with early-stage breast cancer found that the women undergoing lumpectomies were more likely to be alive 10 years later than women with the same diagnosis who underwent a single or bilateral (double) mastectomy. They were also less likely to have died of breast cancer. In 2016, Harvard cancer surgeon Dr. Mehra Golshan reported that of almost half a million women with breast cancer in one breast, those undergoing double mastectomies did not live longer than women undergoing a mastectomy in only one breast. These are just the latest studies – for more information about the years of consistent evidence that less radical surgery is better, see this article.

And yet, an increasing number of U.S. women with early-stage breast cancer are choosing to have both their breasts removed “just to be safe.” A 2015 study conducted by researchers at Vanderbilt University reported that, for women diagnosed with early-stage breast cancer in one breast, the rates of double mastectomy increased from 2% to 11% from 1998 to 2011. Researchers found that decisions to have a double mastectomy increased more for two groups of women: 1) Women with ductal carcinoma in situ (DCIS) where there are abnormal cells inside a milk duct in the breast that won’t spread and aren’t dangerous unless breast cancer develops later; and 2) Women with cancer only in one breast that has not spread to the lymph nodes. This year, researchers from Emory University reported that the percentage of women over 45 getting double mastectomies for early-stage breast cancer in one breast increased from 4% to 10% in less than a decade. For women ages 20-44, the percentage tripled from 11% to 33%. To some extent, geography was destiny: in five Midwestern states (Nebraska, Missouri, Colorado, Iowa, and South Dakota), 42% of the women who got surgery had a double mastectomy.

The bottom line is that women with DCIS or early-stage breast cancer have more effective and less radical treatment options than mastectomy. Even women with BRCA1 or BRCA2 may never develop breast cancer, and if they do, they may not need a mastectomy. 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.

So, the good news for women newly diagnosed with cancer is that mastectomies are not the best choice for most women if they want to live longer. Women should be aware of treatment choices for breast cancer and encouraged to make decisions based on their own unique situations. For each woman, it is 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. Each woman should make the decision that is best for her, based on information, not on fear.

Read the original article here.

Breast Implants Linked to Rare Cancer

Diana Zuckerman, PhD, National Center for Health Research, Our Bodies Ourselves: March 28, 2017

Last week the media discovered that breast implants can cause cancer. Rather than causing breast cancer, experts now say that breast implants can cause a type of lymphoma (cancer of the immune system) called anaplastic large cell lymphoma (ALCL).

You’ll be excused for thinking this is news. The truth is that experts have known that breast implants cause ALCL since at least 2013, and some of the foremost plastic surgeons in the country were discussing it behind closed doors since at least 2010.

The U.S. Food and Drug Administration (FDA), which is responsible for making public information about the risks of medical devices, including breast implants, first published a report on its website about ALCL and breast implants in 2011. At that time, they said there was evidence that implants might possibly cause ALCL. The FDA’s report came months after an article published in Allure magazine stated that plastic surgeons and their medical societies were studying the possible link between breast implants and ALCL.

Articles subsequently published in medical journals concluded that breast implants cause ALCL. But despite the growing evidence, the FDA didn’t update its website to officially report that breast implants really can cause ALCL until last week. That’s when the media realized it was a real story.

If you think women should have been told this sooner, here’s what you need to know:

In May 2016, the World Health Organization published a report that included the term breast implant associated ALCL (BIA-ALCL). A few months later, the National Comprehensive Cancer Network (NCCN) released the first worldwide oncology standard for the disease. The guidelines (you need to sign up for a free account to see them) include a guided algorithm for surgeons and oncologists to test for and diagnose the disease. The authors conclude that any abnormal accumulation of fluid or a mass that develops near the breasts months after breast implants are implanted must be evaluated.

They also state that even if the BIA-ALCL is confined to the scar capsule that surrounds the implant and even if that capsule is totally removed through proper explant surgery, the patient must be followed for 2 years to make sure the ALCL is eliminated.

Why didn’t plastic surgeons or the FDA make that information more widely available? I’m sure there are women and their doctors who would have benefited from that information in the last few months.

In 2015, plastic surgeons who had denied any link between breast implants and cancer for more than two decades published an article in a plastic surgery journal about 173 women with ALCL that was caused by their breast implants.

However, plastic surgeons across the country focused on reassuring women that BIA-ALCL is “very rare” and the FDA echoed that mantra.  But, although rare, it seems that BIA-ALCL is not “very rare.”  In Australia, which can track medical problems from any kind of implants better than the tracking of implants in the U.S., the Australian Department of Health estimates that BIA-ALCL affects as many as one in 1,000 women with breast implants.

The estimates of plastic surgeons and the FDA are much lower in the U.S., but there is no reason to think BIA-ALCL is less likely to develop in women in the U.S. than in Australia. Given the dramatic increase in BIA-ALCL diagnoses in recent years, it is clear that BIA-ALCL was under-diagnosed and under-reported for many years.

For women with ALCL, it doesn’t matter how rare it is. The sooner it is diagnosed, the more likely it can be cured easily by removing the implants and scar capsule surrounding it. At later stages, women will need chemotherapy and are less likely to survive, according to research conducted at the MD Anderson Cancer Center that was published in 2013.

The study followed women for 5 years and found that ALCL related to breast implants sometimes requires chemotherapy, and approximately 25% of the implant patients with the more serious type of ALCL died during the 5 years following their diagnosis. You can read more about the study here.

ALCL caused by breast implants can result in swelling, which is often mistaken for an infection and treated with antibiotics. Antibiotics are ineffective against ALCL and the delay in timely and appropriate treatment for ALCL is dangerous.

A published response in the same medical journal urged physicians to respond quickly and to check patients who have swelling near their implants for ALCL. This would require cytology testing rather than testing for bacteria.

This news is especially important to women who undergo mastectomies to prevent cancer or for DCIS or very early breast cancer, either of which is equally likely to be cured with a lumpectomy instead. Women trying to beat cancer by undergoing a radical surgery they don’t need are unlikely to do so if breast implants will put them at risk of developing a different type of cancer.

The news is equally frightening to cosmetic surgery patients. Many health insurance companies refuse to cover the cost of medical tests or treatment for women with breast problems related to cosmetic breast implants. We now know this can result in undetected ALCL, which can be fatal. In addition, delays in treatment for ALCL can be extremely expensive for patients and their insurance companies; the companies would be required to pay for treatment for ALCL when it is eventually diagnosed at a later stage.

Women deserve to know the facts.  And they deserved to know them years ago.

Read the original article here

Angelina Jolie’s Decision

Diana Zuckerman, PhD, National Center for Health Research, 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.

Read the original article here.

Breast Implants as Therapy? Not So Much

Diana Zuckerman, PhD, National Center for Health Research, Fem2.0: April 11, 2013

Cross-posted from Fem2.0 with permission.

More than 300,000 teens and women in the U.S. decide to get breast implants every year.  To hear them talk about it, you’d think they were getting therapy instead of surgery.  They almost never say “I want larger breasts” (or even “I want better boobs.”)

What they say is “I don’t like my body and I want to feel better about myself.”  And plastic surgeons will tell their patients “this will really improve your self-esteem.” But their advertisements seemed designed to make us feel insecure about our bodies, not better about ourselves.

Unfortunately, breast implants don’t deliver on that promise of feeling more self-confident. 

On the contrary, the breast implant companies’ own studies prove it.  There are 2 major breast implant companies in the U.S., Allergan and Mentor.  Both tried to prove to the FDA that breast implants helped women’s self-esteem and both failed miserably.  Allergan used 12 different quality of life measures to compare augmentation patients before surgery and 2 years later.  Nine of the 12 (75%) were worse after the women got their breast implants, including self-esteem. 

The results were similar for women getting Mentor breast implants.  The women got worse in their self-reported physical health and mental health, with most showing no difference in their self-concept or how they felt about their body.

Why do they feel worse?  For some women, it is the disappointment that even after plastic surgery they are still not beautiful enough.  And for some women, the complications from breast augmentation — numb nipples, hard or painful breasts, and for some women chronic fatigue or other problems – make them feel physically messed up and guilty because they “made a stupid decision and now I’m paying for it.”

Choosing breast implants

Myth and Reality

Where does the myth of breast augmentation as therapy come from?   Wouldn’t you think that any cosmetic surgery would make women feel better about themselves?

If you ask women (or men) who had plastic surgery how it influenced them, many will say that they feel better about themselves.  But, memory can play tricks on us.  For example, some of us have mostly wonderful memories of our childhood and others have mostly sad memories, but those memories aren’t always accurate.  The best way to find out what the impact of breast augmentation – or any cosmetic surgery – is to interview the people before the surgery and again after they have completely recovered from surgery and gotten used to the “new me.”

Study after study shows that men and women who get plastic surgery usually feel better about the body part that was “fixed” but they don’t feel better about themselves and they don’t feel better about their relationships or their lives.  How we feel about ourselves is a central part of who we are.  It doesn’t change easily. For example, a “good hair day” or a great outfit can help us feel more attractive, at least for a while, and can help us have a good day, but it doesn’t make us feel more worthwhile as people or happier in our lives in general.

Psychologists explain that this is the difference between a “state of mind” (feeling good because I’m having a good hair day) and a personality trait (how I feel about myself because of my high or low self-esteem).

Plastic surgeons like to believe that they make magic by making people feel better about themselves.  And the “beauty industry” helps convince us that if we just buy the right product (whether it is a cosmetic, an outfit, or a surgery) will make all the difference.  For example, “makeovers” – whether in magazines or on TV – work by making the women feel awful about themselves at first and then “curing” their shortcomings.

Teenagers are the most vulnerable

Teenagers are especially likely to feel bad about how they look.  But every year throughout the teen years, boys and girls tend to feel better about how they look.  By the time they are 18, they feel much better than they did at 13 or 14, for instance.  If they get plastic surgery as teens, they think that’s the reason they feel better, but the truth is that even teens who don’t get plastic surgery and don’t necessarily look better than they used to, still feel more comfortable with how they look as they get a few years older.

One more thing to keep in mind: women who get plastic surgery once tend to want more plastic surgeries.  In other words, after fixing one perceived flaw, they find other flaws that bother them and that they want to fix.  That’s another sign that breast augmentation and plastic surgery are not the way to improve self-esteem.

Therapy vs. Plastic Surgery

Why are so many women so unhappy with how they look, and especially with their bodies?  The standards seem to be getting more unattainable.  Let’s face it: thin bodies with very large breasts don’t happen in nature very often.

I’ve talked to actresses about this and I call it the trickle down insecurity effect.  Beautiful women are more likely to become actresses or models than plain Janes, but as they struggle to make it in Hollywood or the beauty industry, they are told they are not quite beautiful enough.  They try extreme diets, personal trainers, professional make-up artists, the best hairdressers, and the most gorgeous outfits.  When even that isn’t enough, they get plastic surgery.  Then regular girls and women see them and feel inadequate as they think “Why can’t I look like that?”

Of course, even movie stars don’t always look as good as they do in magazines or movies.  In real life, there is no photoshopping, airbrushing, or flattering lighting to fix the imperfections.

But the bottom line is: if you want very large breasts, breast implants can help.  If you want to feel better about yourself, breast augmentation isn’t the answer.  Therapy might be.  And, it can also help to stop comparing yourself to women whose images aren’t real, but have instead been manufactured into unattainable ideals of beauty.

Perfecting Bodies Through Chemistry?

Diana Zuckerman, PhD, National Center for Health Research, Fem2.0: February 22, 2013

Cross-posted from Fem2.0 with permission.

Do you like your body?   If there was a simple way to change it, with no risks, would you do it?

If making that change meant you would put your health at risk and have multiple surgeries for the rest of your life, would you hesitate?

Most women say they don’t like their bodies, and research shows that dissatisfaction usually starts during the middle school years and may never go away.  For many of us, it eases up a little in young adulthood as we come to appreciate our attributes and accept any “flaws,” but insecurities rev up again as aging takes its toll.  It seems ironic that we long to regain the body that seemed so imperfect when we were younger.

Breast-Implant-gel

In the U.S., there are thousands of products and procedures that feed on women’s insecurities.  Most are ineffective – the pills and products that promise to melt fat away without diet or exercise, or to make cellulite or wrinkles disappear.  But only a few are actually dangerous to our health.  Breast implants are one of those.

The FDA just approved a new kind of breast implant, which many plastic surgeons promise will be safer and better than other kinds of breast implants.  It is made of thick silicone gel (nicknamed “gummy bear implants” for its consistency), which is supposed to prevent it from breaking, leaking, or wrecking havoc with your body.

What’s the proof that this product is safer, or even safe at all?  Apparently, that’s a secret.

When breast implants were first sold in the U.S. in the 1960s, no testing was required to make sure they were safe.  For the next 30 years, more than a million women in the U.S. got breast implants, not realizing that studies on women had never been done to prove they were safe or to determine how many months or years they would last.

In 1990, I was working as an investigator in the U.S. House of Representatives when a Senate staffer called me.  She told me that her mom had gotten breast implants after a mastectomy, which had resulted in terrible problems including silicone leaking out of her nipples.  Her mom was cured of cancer but the implants had put her through hell.  I was sure that the FDA had very strict rules about safety testing, but I promised I’d look into it.

I found out that I was wrong: the FDA had never required clinical trials for breast implants.  We held a Congressional hearing, I continued my investigation, and soon my office – and the media – was full of horror stories about women whose health had been ruined by breast implants.

Thanks to Congressional and media pressure, the FDA changed their policies.  They eventually required breast implant companies to conduct studies on hundreds of women with breast implants, to find out how safe their products were.  Public meetings were held so that women could testify about their experiences, scientists could openly discuss the research, and the media could report what was said.  Some companies failed to do the newly required research and their implants were no longer allowed to be sold in the U.S.  And, although all breast implants were found to have high complication rates, the FDA, under tremendous pressure from implant companies and plastic surgeons, decided that women were capable of making an informed choice about the risks they were willing to take.

I have no doubt that women are capable of making an informed choice.  But the FDA is still not providing the full information that women need to make an informed choice, and neither are the plastic surgeons.

In a giant step backwards, some FDA officials are reverting to their old ways.  They approved “gummy bear” implants with no public meeting and they have not made the study findings public.  Instead, in a press release that the agency quietly released on February 20, they report that the new breast implants have the same kind of complications as other types of implants – such as hard, painful, or lopsided breasts and the need for additional surgery – but don’t say how often those complications occur.  They also reported a new complication: the silicone gel in these new implants can crack.  What happens to women when that happens?  The FDA isn’t saying.

Since I did my investigation in 1990, I have been one of the FDA’s strongest critics and biggest fans.  I have often been horrified by some of the decisions FDA makes to approve unsafe or inadequately tested medical products, but I also know that when the FDA does its job well, it can save millions of lives.

When I did the Congressional hearing on breast implants, I was 7 months pregnant.  My son is now a college senior.  In those 22 years, the FDA regained and is now again at risk of weakening its public health focus, as Congressional pressure on the FDA to protect patients has been replaced by Congressional pressure to get products to market as quickly as possible and thus “create jobs.”  Whether it is breast implants, riskier birth control pills, TB drugs that do more harm than good, or sleeping pills with questionable benefits, the FDA is allowing drugs to be sold that do a lot of harm.  And when the FDA fails to hold medical products to a high standard, it is women – the consumers of most medical products – who are harmed the most.

Read the original article here

Safe Enough?

Diana Zuckerman, PhD, The Washington Times: August 28, 2005

How safe need an implant be before the Food and Drug Administration decides it is “safe enough” for a surgeon to put it in your body? The answer may surprise you.

Congressional leaders from both parties continue their scathing criticism of FDA for failing to protect consumers from unsafe medical products. Vioxx is the most obvious example but far from the only one.

The problem is not just prescription drugs. In just the last few weeks, the FDA announced the potentially fatal risks of heart valves and defibrillators. And, the FDA now seems poised to make another blooper, recently announcing their intention to approve silicone gel breast implants for the first time.

Pundits have had a field day, castigating women’s organizations for expressing concerns about a product that implant makers and plastic surgeons assure us is perfectly safe. They trot out flawed research and old reports to back up their claim, conveniently ignoring evidence that conflicts with their conclusions.

A cardinal rule of medical research is some products that seem safe at first may be found harmful years later. When the National Academy of Sciences first published a report on Agent Orange in 1974, for example, it concluded there was no clear evidence Agent Orange harmed Vietnam veterans. Years later, scientists concluded it causes birth defects and several types of cancer. Similarly, the first Institute of Medicine (IOM) reports of “Gulf War Syndrome” concluded war exposures had not caused health problems. Scientists now agree Gulf war veterans are at increased risk of ALS (Lou Gehrig’s disease), and possibly other fatal diseases.

In 1999, the IOM concluded there was no evidence implants caused diseases. Instead, they were concerned implants could break or interfere with mammograms, cause pain, or require additional surgery. They reviewed all the studies published, but many were of animals or cells. There were very few clinical trials or epidemiological studies of women with implants, and almost all were funded by Dow Corning, the company that makes silicone and commissioned the studies to avoid losing billions of dollars in legal settlements with implant patients who became ill.

As an epidemiologist, I realized the Dow studies were scientifically flawed. Since most cancers or autoimmune diseases take many years to develop and be diagnosed, the studies should have focused only on women who had implants for at least seven to 10 years. Instead, they included many women who had implants for only a few months or years. The studies also included small numbers of women who had implants for 25 years or more — but those “silly putty” breast implants were much thicker and more durable than the implants sold after 1980. It would not have mattered who paid for the research if it was well designed — but it wasn’t. That is why scientists wonder if the studies were designed to prove implants safe, rather than determine if they were safe.

In contrast, in studies funded by the National Cancer Institute or the FDA rather than implant makers, findings were dramatically different. By studying women who had breast implants for at least seven years, they included many women whose implants were possibly leaking. The results showed statistically significant increases in several cancers and autoimmune diseases. They also found a doubling of deaths from brain cancer and a tripling of deaths from lung cancer when women with implants were compared to other plastic surgery patients, even though the two groups are very similar in access to health care, smoking and other health habits that could influence disease.

When symptoms are studied instead of diseases, even short-term research reveals implant problems. In 2003 and 2005, the FDA scrutinized two breast implant makers’ research. A surprising number of patients were found to have pain, broken implants or other problems that required surgical removal of their implants within the first three years. Even more surprising, women were more likely to report autoimmune symptoms, such as joint pain and fatigue after having these implants for two years, compared to how they felt just before getting implants. Statisticians note these differences were not caused by aging.

In a recent rant in this newspaper, Steve Milloy accused me of frightening people about the risks of breast implants, and accused other women’s organizations of ignoring scientific evidence of the safety of implants. I would be happy to sit down with him and together examine every single study. Unfortunately, accurately describing research results sometimes frightens people. But what really frightens people is learning too late they can’t trust FDA-approved medical products, whether painkillers or implants.

Why are so many Americans harmed by FDA-approved products? It has been suggested companies sold products they knew were unsafe. In some cases, the FDA has been accused of ignoring the allegations or even actively helping to conceal them. For example, when the FDA closed its criminal investigation of Mentor, an implant maker, the agency compliance officer resigned in disgust and complained to the FDA commissioner. A congressional investigation continues into the matter, but FDA officials seem ready to approve breast implants before the ongoing congressional investigations are completed.

Are silicone breast implants safe enough for breast cancer patients? Are they safe enough for people you care about? Implant makers have flooded medical journals with articles claiming they are. The few government studies raise important, never-answered questions about long-term safety. The key question here is what does the FDA mean by “safe enough?”

 

Breast Implants: A Woman’s Choice, But a Safe Choice?

Diana Zuckerman, PhD, National Center for Health Research, Fox News: April 25, 2005

Women have the right to buy products that will make them look better or feel better about themselves. Are silicone breast implants part of that inalienable right to choose?

The companies that make silicone breast implants, the plastic surgeons who use them, and the women who want them are all focused on that right, and angry that it has been restricted for the last 13 years. They question the motives of government officials, women’s organizations, and health advocates that question that right.

On the other side of the debate, consumer groups, public health advocates and others remind us that the Food and Drug Administration has the responsibility of approving medical products only if they are proven safe and effective. Implants are especially worrisome because it costs thousands of dollars to have them removed. If these products are risky or can break inside the body, that risk should outweigh the benefits.

Breast implants have become such a hot topic that pundits who otherwise wouldn’t talk about the FDA or women’s issues have gravitated toward the topic. Many pundits have become instant experts on the subject, even if they have never spoken to any woman about her implant experiences and never read any of the safety studies they quote.

But like most hot topics, this one is complicated. If you talk to women, read the research, and try to figure out why there are such strong opinions on both sides of the issue, you’ll find out why the controversy has continued for 15 years and is not yet resolved.

This is what we already know about breast implants:

Dozens of studies of women who had implants for a short time find no significant increase in diseases. Most of these studies are funded by companies with a financial interest in breast implants. Studies conducted by implant makers and analyzed by the FDA found that more than one in three patients report complications such as breast pain and hardness and the need for additional surgery within the first three years.

Only two studies have been conducted on the health of women with leaking silicone implants. One, conducted by FDA scientists, found a significant increase in fibromyalgia and other autoimmune diseases. A study funded by a silicone manufacturer found an increase in autoimmune symptoms such as fatigue and mental confusion but not in diagnosed diseases.

Studies conducted by the National Cancer Institute are the best-designed because they compare women who had implants for at least seven years to other plastic surgery patients and to women in the general population. They found that all plastic surgery patients, including breast augmentation patients, tend to be healthier and wealthier than women of the same age in the general population. Plastic surgery patients also have similar health habits.

However, compared to other plastic surgery patients, breast augmentation patients are twice as likely to die of brain cancer, three times as likely to die of lung cancer, and four times as likely to commit suicide. They are more likely to report autoimmune diseases, but their medical records indicate that patients are not always accurate in their reporting (for example, many women who report having rheumatoid arthritis actually have osteo-arthritis instead). These government scientists concluded that the results were inconclusive and more research was needed.

The testimony of women with breast implants was surprisingly consistent with these research studies. Many of the women praising their implants had them for just a year or two. The women who were testifying against implants usually had them for 10 years or more. Many spoke of being happy with their implants for years, and then slowly becoming disabled from chronic fatigue, mental confusion, and aches and pains at the ripe old age of 32. After years of being told that their illness was unrelated to their implants, they eventually had their implants removed, and only then learned that the implants had ruptured and were leaking.

Ed Brent, a widower from Atlanta, described his wife, P.J., as very happy with her implants for years. When she became ill, she sought medical treatment but none of the doctors were able to help her. Frustrated by the lack of effective medical care and feeling guilty because her children became seriously ill after she breastfed them with implants, P.J. Brent committed suicide.

Ed testified that after her death, doctors found exceptionally high levels of platinum in her blood, and in the blood of the children she breastfed after implants (but not those breastfed before). Platinum is a potentially toxic substance that is used to make breast implants. Research published last year found high levels in the breast milk, blood and urine of women with implants, compared to other women.

This is what we don’t know about breast implants:

We don’t know how long they last, although many studies suggest that 10-15 years is likely.

We don’t know how often they leak silicone outside the implant area, but the FDA estimates one in four women with leaking implants have such leakage. Will that eventually become 100 percent if a woman doesn’t have her implants removed? Nobody knows.

We don’t know what percentage of women will get sick from breast implants that are intact and what percentage will get sick from breast implants that are leaking. No studies have been done to examine that over time.

We don’t know if breast implants make most women feel better about themselves. According to the companies’ own studies, women who got breast implants two years earlier tend to feel worse about their lives and themselves, not better, than they felt before getting their implants.

Can women make an informed choice about breast implants? Most women who make a decision about breast implants get their information from their plastic surgeon, the implant maker’s patient booklet, or the Internet. The plastic surgeons tend to be very positive, the company brochures tend to be confusing, and the Internet has information ranging from extremely positive to extremely negative and everything in-between.

The bottom line: men and women have a right to choose safe medical products, and it is the FDA’s job to determine if a medical product is safe. Whether the product is a painkiller, an anti-depressant, or a breast implant, FDA approval should be made on science, not wishful thinking or philosophical musings about choice.

Read the original article here

 

A Split Decision on Breast Implants

Diana Zuckerman, PhD, National Center for Health Research, The Washington Times: October 26, 2003

Breast implants are back in the headlines, with two equally passionate sides to the story. Both claim the science is on their side. Who is right?

In a split decision on October 15, advisers to the Food and Drug Administration voted to recommend that silicone gel breast implants are safe enough to have the FDA ‘seal of approval.’

The 9-6 vote for approval was orchestrated by the six plastic surgeons and breast surgeons on the panel who voted in lock-step. In contrast, most of the other doctors and scientists voted against approving the implants, citing the lack of safety information. To add to the drama, a panel member who seemed ready to vote against approval mysteriously disappeared before the vote. And the panel chairman, who only votes when there is a tie, said he would have voted against and was flabbergasted by the lack of safety information.

The spin machines are already working overtime. Plastic surgeons and implant manufacturers (and the lobbying and PR firms they generously support) remind us that women like silicone gel breast implants. They tell us that there is “no scientific evidence” that breast implants cause disease and that it is time to make them widely available again. They often back up this statement with a 4-year old Institute of Medicine report, which they claim proves that implants are safe.

On the other side, patients testified about the pain and deformity of having leaked silicone scraped from their chest wall– a problem that is considered a “local complication” rather than a “health risk.” Their testimony is the heartbreaking illustration of the Institute of Medicine report’s concerns that breast implants can break, leaking silicone inside the body. Although the Institute concluded that research did not prove implants cause disease, their report was only a review of the research available four years ago, most of it of women with implants for just a few months or years.

Most diseases — lung cancer for example — take more than a few years to develop. Implants tend to break after eight years or more, and the health risks of leaking silicone implants aren’t known. When scientists from the National Cancer Institute and the FDA recently conducted several studies on women who had implants for at least seven years, their results were frightening: Women with breast implants were twice as likely to die from brain cancer, 3 times as likely to die from lung diseases, and 4 times as likely to commit suicide, compared to other plastic surgery patients. Women with leaking implants were more likely to have fibromyalgia and several other autoimmune diseases.

The FDA advisors who voted against approval included a toxicologist, epidemiologist, radiologist, statistician, dermatologist, and cancer surgeon. They understood diseases take time to develop, especially since breast implants tend to break after 10 years, not two years. Their vote against approval was based on their concerns about long-term safety, and their criticisms that the company didn’t bother to study women who had implants for more than three years.

There’s even a divided opinion among our government health officials about the safety of breast implants. At the very moment when the FDA is considering lifting restrictions on silicone gel implants, the Medicare program has successfully sued implant manufacturers for tens of millions of dollars. Why? Because the government claims that women who became sick from their silicone implants have cost Medicare a lot of money in medical care.

You might wonder why the FDA would consider making a product more available when scientists question their safety and when government experts believe that it has cost our already-strapped healthcare system millions of dollars. This is a health question where it doesn’t help to ask your doctor –but you might try the lobbyists on Washington’s K Street. The companies that were successfully sued for billions of dollars by breast implant patients — such as Dow Corning, 3M, and Bristol Myers Squibb — are among the most powerful companies in the country. Perhaps their lobbyists are more effective than the women with implants who are coping with leaking silicone in their bodies.

The FDA’s mission is to safeguard all of us when we eat, use medical products, or are vaccinated. The division of opinion among FDA advisers reflects a frequent split — between those who are selling a product or procedure and think it is safe based on personal clinical experience, and those who believe research is necessary to prove such safety

There is passion (often called hysteria when it’s the “other side”) and science on both sides of this issue. The short-term research shows most women with breast implants don’t get diseases in the first few years. But there is little long-term research, and those studies raises serious questions about leaking silicone, illness, and death related to implants. In the meantime, research also shows extremely high complication rates — including the need for repeated surgeries. The bottom line is: Will the FDA demand a company prove its product is safe before “approving” it, or decide a company can experiment on millions of women while we wait for research to be completed?

We’ll find out soon.