Diana Zuckerman, PhD, October 6, 2011

Conclusion of Post-Approval Studies: Many of these rates are too low to provide useful data for augmentation patients.

Rupture Rate: The FDA mistakenly reported the rupture rate per implant as if it were per patient. Previous data shows that the price per implant is approximately twice as high as per implant.

Why the Poor Follow-up?

Once company did a much better job than other. There is no excuse for Mentor’s poor performance because their patients and studies are like Allergan’s.

Plastic surgeons tell women that complaints are so safe that the women aren’t concerned about follow-up. Does the contribute to patient’s lack of interest in participating in these studies? Or are incentives poor? In addition, women are being “fired” by their plastic surgeons.

Cumulative Complications

Cumulative complication rates are decreasing in data the FDA has presented now compared to a few years ago! That’s impossible. They should stay the same or increase from 4 years to 10 years. (Allergan: swelling decreased from 23% to 9%)

Since come complication rates are going down there is a problem with the data. Either the company is not reporting complications correctly or the sample is changing in ways that reduce complications.

Cumulative Complications

Mentor seems to have stopped reporting certain complication rates. For example, asymmetry. For example, asymmetry and ptosis, 2 complications for reconstruction patients, are simply not reported at 8 years.

What else might Mentor have decided not to report?

Given these problems, it is difficult to have faith in the integrity of the Mentor data.

Conclusions:

Incentives are lacking for companies or surgeons to do post-market research correctly. Enforcement is needed to provide incentives.

Data are not capturing the problems many implant patients report-especially Mentor.

Literature is funded by silicone and implant companies, and medical foundations with conflicts of interest.

Pam Noonan-Saraceni

I was diagnosed with breast cancer and had a mastectomy at the age of 25.

I waited 5 years before I decided to have reconstructive surgery. I played tennis, jogged, and taught aerobics.  But the prosthesis often shifted or fell out of my bra when I perspired.  So, as a well-educated woman, I did my homework on breast implants prior to choosing the plastic surgeon to perform my reconstructive surgery. However, I was told that they would “last a lifetime” and “complication were rare”.

Within 3 months of the initial reconstruction, I was back on the operating table. My body had formed a capsule around the implant and the implant had shifted up under my collarbone. The searing pain at that time was causing my shoulder to become immobile.

My symptoms began slowly. At first I attributed the fatigue, aches, and pains to just getting older. (I was only 36 years old!) This was 6 years after I had been implanted.

Then I got a severe case of the flu, and 6 weeks later I was still so fatigued that my life was being drastically effected. I had GI problems, sleep disorders, night sweats, chronic fatigue, myalgias, and joint pain.

Before I had the implant removed  (10 years after the initial reconstruction), I was again wearing a partial prosthesis over the implant. Capsular contracture had again become a problem and I was misshapen and lopsided. The explantation was the 5th surgery at my breast site.

I never fully recovered.  I have gone to various doctors and specialists and have been given a list of various possible diagnoses. Atypical Connective Tissue Disease is number one, but that diagnosis was made quite a bit later, not within the first 10 years.

To date, my out of pocket medical expenses exceed $40,000. My husband and I are self-insured. The insurance policy that we took out carried an exclusion. I was not covered for any illness or disability related to the reconstructive surgery. Apparently the insurance companies understood that there are health risks associated with breast implants and they are not willing to bear the financial costs.

There is not a miracle cure for me. But I hope that by telling you what happened to me, you will understand why better research on breast implants is so important.

Kathleen Van Fossen Nye

My name is Kathleen Van Fossen Nye and I am from Reading PA. I am not well enough to travel to this meeting so I thank you for the opportunity to have my words read before this panel.

I first got breast implants after undergoing a bilateral mastectomy at the age of 22 at the U.S. Naval Hospital in Portsmouth, VA.

My experience with implants is like a history book on breast implants, because I started with some of the early implants and those were repeatedly replaced as newer models became available.

I beseach you to make sure that well-designed and implemented long-term studies are conducted on all breast implants that are sold. Then make these studies available to the public on the internet so women can read them for full disclosure.

When I was 22, the doctor claimed I was lucky to live when reconstruction was available with silicone breast implants. He said before the implants I would have walked around with a sunken chest. He also said they would never sag, that I would be the sexist old lady in the nursing home. In addition, they would self-seal if I was stabbed in the breast.

I wasn’t so lucky, after all.  My original breast implants had to be cut off my chest wall, because the mesh backing from the implants grew into the chest wall. The implants had become as hard as rocks.

I was told that the new silicone gel implants were greatly improved and would not get hard. In addition, if for any reason they do get hard, all the doctor had to do was squeeze the breast until they break the scar tissue capsule.

Claims of being able to break the scar capsule were not true. After 5 years of squeezing the hardened breast, I could no longer take the pain. My doctor told me it was my fault because I had no breast tissue. However, he told me that the new Meme implants were covered with polyurethane foam that would stay soft and never get hard, so he was going to use these new and improved implants.

When asked about the safety of the foam, I was told to trust the doctor because he knew what was best for me.

And yet, the new implants also got hard.  The old Meme implants were removed and I had surgery to get a new set of Meme implants.

For 3 years I was weak and sick and after visiting three different doctors complaining of pain and lumps on the edge of the implant, two doctors told me it was scar tissue. The third doctor said to give me peace of mind he would remove the lumps. The implants were removed and the 3 lumps were biopsied.

Foreign material was found in two of the masses.  The mass that was sandwiched between the other two was cancer.

After chemo and radiations treatments I had two expanders and I was implanted once again, against my wishes.

Within 3 months, I developed necrosis and the implant pushed itself up and out through my skin.

My physical health has suffered greatly. I have had over 25 breast related surgeries, including 6 sets of implants and 4 single silicone implants, 2 expanders, and 4 individual saline for the left breast.

I now have lupus and many other health problems.

I have given my history to show you that there is always great optimism about the newly designed implants, but as the years go by, the optimism gives way to reality and those old implants are always replaced with new ones, until those new ones become the bad old implants that need to be replaced.

It is 49 years and about 3 generations of women since Drs Cronin and Gerow implanted the first breast implants. If the manufactures’ make safety claims, they should back them up with studies that really provide accurate long-term data, not biased samples where half of the patients are missing and we don’t know if the half that are missing are healthy or terribly sick.

Anne Stansell

My name is Anne Stansell and I live in New Mexico.  I wish I could be there today, but I hope you will listen to my story.

I am a breast cancer survivor. I was diagnosed at the age of 39. The doctor said I needed mastectomies, radiation therapy, and breast implants. Implants were just part of the treatment, no discussion. I trusted the doctors who I felt had just saved my life.

I was fine for the first five years. Then I became very ill. I was diagnosed with Graves Disease and fibromyalgia. My eyes were so dry that my retina tore.

My implants were taken out about two years later. I had to fight with my insurance company to get them to cover the removal.

Half of one of my implants was gone. Where did the silicone go? I don’t know.  Here is a photo of me with my half empty implants.

They couldn’t remove all the silicone from my body, but even so I began to get better almost immediately. My family noticed the difference even before I did.

I’m still recovering, and I can work some now.

When I heard about the new post-market studies, I saw that the complication rate was high, but was surprised that the complication rate wasn’t even higher.  I had many of the same local complications. I can’t even remember how many surgeries I needed. Silicone was found in my side, when it migrated from the broken implant.

At a previous meeting, the data indicated that cancer patients and augmentation patients also had an increase in some autoimmune symptoms during the first two years after getting implants. I think my symptoms started in the third year, so it is likely that those signs and symptoms will increase over time, just like mine did.  But it doesn’t seem that the post-market studies measured symptoms.  It seems that they just measured diagnosed diseases.

When the FDA approved breast implants, they demanded post-market studies to find out how often these debilitating complications occur.  But based on the women I’ve talked to with breast implants, it seems that the women with implant problems tend to stop going to their plastic surgeons and are therefore dropping out – or being intentionally dropped out – of the studies.

I didn’t have informed consent as a cancer patient, and from what I hear from other patients, that is still true today.

This meeting is focused on research but to do the right research, you need to listen to the patients who were harmed by implants.  We illustrate the data. We are the examples of what can – and has – happened to tens of thousands of women across the country.

Carolyn Wolf

My name is Carolyn Wolf; I live in Virginia. I have paid my expenses to be here and I have no conflicts of interest.

At 41, I had subcutaneous mastectomies due to fibrocystic disease.  Reconstruction was with Dow Corning silicone implants (1972).

Seven years later, small burning blisters formed on my neck. I stopped wearing neck jewelry, though allergy tests were negative. I wear no makeup.   I continue to develop these blisters, and other implants report they have similar blisters.

By the 15^th year, my implants had become very hard; after 17 years I was hospitalized for 3 days with all the  symptoms of a heart attack, but tests showed no heart problems. I asked the internist “could the implants have caused this?” and was told “no”. In hindsight, I think this episode was the result of silicone leaking from my left implant.

Three years later, I had developed joint problems on my left side,  my shoulder, elbow, knee, ankle and foot. Gradually my fingers and toes became numb.

I went for checkups every year at Walter Reed. No suggestion was ever made for an MRI until a bubble appeared on top of my right breast, about 26 years after getting implants. Because there was a long wait to get an MRI, a radiologist did an ultrasound. The report was “no cancer, everything okay”.

About a year later, I started feeling burning in my scalp; it felt like a red hot worm crawling along the part line.  I also had three episodes when long strings of silicone came out of my ear.

Twenty-eight years after implantation, the left breast collapsed fully.  I finally had my firstMRI, which showed both implants extensively ruptured. When the implants were  surgically removed in 2000, the total material that came out would not have filled a small sized Styrofoam coffee cup.  Obviously the rest had leaked or deteriorated into my body.

Because of continuing dizziness and brain fog, a brain MRI was performed in 2001.  This showed more than 20 lesions on my brain.  EMG tests showed much damage to my left eye, to my left arm and hand, and extensive neuropathy in the extremities. The neurologist studied a Mayo –he was no charlatan.

Three years ago I was hospitalized with Giant Cell Temporal Arteritis, with the same pain in my scalp.  I have been able to control the inflammation with high doses of Prednisone.

I am diagnosed with connective tissue disease, multi-nodal thyroid chronic fatigue; fibromyalgia, PMR, asthma and COPD; MS-like syndrome with neuropathy; platinum poisoning (my platinum lever is 140, 35 times normal by CDC/OSHA standards), and Irritable Bowel Syndrome.

I am not the only woman with these kids of experiences.  There are still thousands of women who have had leaking silicone breast implants in their bodies for decades.  Many cannot afford surgery to remove them. Others, like me, had doctors who told them that their health problems are unrelated to their implants.  In recent years, many of those doctors are saying “the FDA says they are safe and leaking silicone does not cause problems.”  And many women believe the doctors, and just get sicker and sicker.  Many of them just “give up” and even commit suicide – and it is NOT because they don’t have knobs on their chests.

I ask the Advisory Committee to think about how your recommendations will affect these women.  Why is there no research focused on the women with leaking silicone implants and what happens to them??  The FDA did such a study 10 years ago, but the manufacturers say the newer implants are safer.  But there are not studies to PROVE whether that is true, because the studies required by the FDA follow women for only 10 years.

Is the FDA willing to publicly state that silicone and platinum leaking into women’s bodies, year after year,  is “perfectly safe”?

So far, the FDA keeps requiring the companies to do research, but the research if NOT getting done properly.  Women are being terribly harmed as a result.

Please make sure that these research requirements are enforced.

Conclusions of Pam, Kathleen, and Anne in their Joint Testimony

So far, the post-market studies have all started studying women from the time they got implants for the next 10 years — although many women dropped out of the studies before 10 years had passed.  In our experience, many women with implant problems have told us that they no longer felt welcome in their plastic surgeon’s office, so they sought health care from other doctors.  We are concerned those are the women who dropped out of the post-market studies.  If they are, then the complication rate is much higher than the studies are reporting.

We have heard on the news where plastic surgeons say that breast implants have been studied more than any other medical device.  We don’t know if that is true, but if it is true, that is an indictment of research on other medical devices.  The studies of breast implants aren’t asking the right questions.  You need independent researchers, not the implant companies, to do this research.

We may not be your typical breast cancer reconstruction patients, but we have talked to a lot of women who have stories just like ours.  The FDA needs to interview women like us, and ask questions about our kinds of symptoms.  Then, include those symptoms in the studies that are done.

And why not find the women who were in the implant studies that started 10 years ago, and follow them for the next 10 years?  Complications are much more rare at first and increase over time.  So, starting with women who had implants put in 10 years ago would provide much more useful safety information than starting with women who got implants 2 years ago.

Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, June 28, 2011

Thank you for the opportunity to testify today.  I am Dr. Diana Zuckerman, president of the National Research Center for Women & Families and our Cancer Prevention and Treatment Fund.  I am also a fellow at the University of Pennsylvania Center for Bioethics.

My perspective is as a scientist trained in epidemiology at Yale Medical School, a former faculty member at Yale and Vassar, and a researcher at Harvard.  I am also speaking as someone who has lost dear friends to breast cancer.

I strongly support the FDA’s decision to rescind approval of Avastin for Stage 4 breast cancer.  I also want to be respectful and supportive of breast cancer patients who are currently on Avastin and seem to be benefiting.

The FDA took a risk when it provided an accelerated approval for Avastin based on preliminary data.  The data now support reversing that decision and I believe it would having a chilling effect on the FDA if it were politically impossible for them to do that.  It would make it much less likely for the FDA to take a chance on promising new drugs in the future if they knew that they couldn’t reverse their decision if better studies indicated that a product’s risks outweigh the benefits.

We’ve heard wonderful stories today from women who have had very good experiences after taking Avastin.  But, the research tells us that for each woman who had a wonderful experience, there was at least one and perhaps two women who had a very bad experience – who died or suffered from stroke or other painful or debilitating adverse reactions to the drugs.  I am here to testify on their behalf as well.

That’s why the FDA needs to rescind approval for Avastin – because on average, women do not benefit in terms of living longer or having a better quality of life.  In fact, women taking Avastin tend to live less long and have a poor quality of life because of adverse reactions.  However, women who are currently on Avastin and seem to be benefiting deserve our attention.  Since the company has made a great deal of money selling Avastin to breast cancer patients and others, Genentech should make Avastin available for free to breast cancer patients who are currently taking it and are doing well.  Genentech should study those women and other women so that the company can determine why some breast cancer patients benefit from Avastin while others are harmed by it.  Genentech should then re-submit an application to the FDA to ask for approval for the subgroup of breast cancer patients who are most likely to benefit from the drug and much less likely to be harmed by it.

It’s unfortunate that Genentech hasn’t yet focused their attention on figuring out which patients will benefit and which will be harmed.  That’s the reason why the FDA needs to rescind approval at this time.  Of course, Avastin would should be available to breast cancer patients who need it.  If Genentech does its part, breast cancer patients who are currently benefiting from Avastin will be able to stay on the drug.

Brandel France de Bravo, Cancer Prevention and Treatment Fund, December 7, 2010

I am pleased to have the opportunity to testify on behalf of the National Research Center for Women & Families, and our Cancer Prevention and Treatment Fund.  I have a Master’s in Public Health and am here today to comment on Gardasil.

Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research to determine what is known and not known about specific treatments and prevention strategies. We do not accept contributions from companies that make medical products.

Guillain-Barré syndrome is one of the “conditions of special interest” being closely monitored among individuals vaccinated with Gardasil. In the general population, GBS has an average weekly incidence of 0.65-2.57 cases per week per ten million people. As those numbers indicate, this sometimes fatal condition causing temporary and even permanent paralysis is, thankfully, exceedingly rare. It is, however, one of the known neurological sequelae of vaccination. The question is: Is GBS more prevalent among people receiving Gardasil?

In a new study to be published in Vaccine, Nizar Souayah and co-authors looked at the VAERS database between June 2006 and September 2009 and compared the occurrence of Guillain-Barré syndrome after vaccination with Gardasil to the occurrence after vaccination with Menactra and influenza. The researchers concluded that the average weekly reporting rate of GBS for the six weeks after vaccination was 6.6 events per week per 10 million subjects, which is double what it was for Menactra (also administered to children 11 and up), and about five times the weekly reporting rate for flu vaccine. When limited to the first two weeks after vaccination, the average weekly reporting rate of GBS jumped to 14.5 cases per week per 10 million subjects vaccinated with Gardasil as compared to 5.7 cases among subjects vaccinated with Menactra.

Three CDC researchers appropriately point out that the VAERS database has numerous shortcomings and that the authors used as their denominator the number of doses distributed, divided by 3, even though not everyone receives all three doses. They also maintain that being a new vaccine, adverse reactions to Gardasil were over-reported. We disagree. While the authors may have worked with too small a denominator, we believe they also worked with too small a numerator. Because VAERS is a passive system that depends on voluntary reporting, adverse reactions are always under-reported. Most parents don’t know how to report problems or don’t find the time to do so, and many doctors under-report as well.

Should we be concerned about the safety of Gardasil?

All of us are here today because we care about the safety of pediatric medications and vaccines. Moreover, as public health professionals we all recognize that a certain amount of individual risk is acceptable for the public good. This is why we can’t talk about Gardasil’s safety without discussing its efficacy.  We must ask what level of protection does it offer and for how long? We must weigh the vaccine’s risks and costs against its benefits, knowing that the balance sheet will look different in each country and even in different communities.

Gardasil’s use continues to expand in the U.S, even though cervical cancer screening is affordable and widely available, and penile cancer and vulvar cancer, for instance, are extremely rare. Here in the U.S., Gardarsil’s main benefit is a reduction in abnormal PAP tests and excisional therapies for CIN2 and 3 lesions. Will Gardasil prevent cervical cancer? We still don’t have the long-term data to determine that. Similarly, we don’t know how long this vaccine-one of the most expensive vaccines and the most expensive routine vaccination ever-lasts. Without that information, vaccinated girls and women, as well as boys and men, could become complacent and fail to take proper precautions.

The modeling analysis done by Ruanne Barnabas shows that a cervical cancer vaccine must last at least 15 years in order to prevent cancer and not just postpone it. According to the data we have on Gardasil so far, its protection is expected to last at least five years. While no one understands or can agree on the level of antibody titers necessary to have protection from HPV, there are data indicating that a significant percentage of vaccinated girls lose their antibody response within five years. Are they still protected? What about 8 years after being vaccinated? What about 10 years after? If we find out that booster shots are needed, will young adults who were vaccinated as children actually get them? What if the booster is expensive and they don’t have coverage for it?

Unless the long-term data prove that Gardasil’s protection lasts significantly longer than five years, we may find that girls and boys vaccinated as pre-teens are losing their immunity when they are most sexually active.

Although Gardasil is safe for most people, Souayah’s study found that girls and young women vaccinated with Gardasil were 8.5 times more likely to visit the ER, 12.5 times more likely to be hospitalized, 10 times more likely to have a life-threatening event, and 26.5 times more likely to have a disability than young people vaccinated with Menactra.

Those numbers would be acceptable if Gardasil saves lives, but we don’t yet know if it will.

In summary, the FDA approved Gardasil on the basis of short-term research, and we don’t yet know how long Gardasil provides protection or when a booster shot will be needed. We also don’t know whether vaccinated girls will grow up to be women who are less likely to undergo PAP smears or HPV testing because they think they are guaranteed to be “one less” woman with cervical cancer, as the ad campaigns have promised. There are a lot of unanswered questions, and we hope you will recommend that the FDA regularly re-evaluate Gardasil’s use as new research data on safety and efficacy become available.

Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, July 20, 2010

I am Paul Brown, and I am glad to present the testimony of Dr. Diana Zuckerman, president of the National Research Center for Women & Families and our Cancer Prevention and Treatment Fund.

Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research.  We do not accept contributions from companies that make medical products, so we have no conflicts of interest.

Dr. Zuckerman is also a fellow at the University of Pennsylvania Center for Bioethics.  Her perspective is as a researcher who was previously on the faculty at Yale and Vassar, was trained in epidemiology at Yale Medical School; conducted research at Harvard, and worked on health issues in Congress, at the Institute of Medicine, and for nonprofit organizations.

We had hoped that new research would support the FDA’s decision to give Avastin accelerated approval for first line breast cancer treatment in 2008.  The drug showed promise in an open-label trial, in terms of progression free survival but not overall survival.

As you can see in FDA’s summary, these two new placebo controlled trials indicate that the drug has a much more modest effect on progression free survival than was claimed in 2007, and no improvement in overall survival.  In fact, the placebo patients tend to do better in overall survival.

Simply put, the patients are dying of other causes related to serious adverse reactions such as heart attacks, strokes, and gastro-intestinal perforation.  Even when these are not fatal, it has a terrible impact on the cancer patient’s quality of life.

Metastatic breast cancer is not curable and most people live less than 2 years, so if treatment can’t prolong survival then the focus on treating these stage 4 breast cancer patients needs to be quality of life.

Avastin does not improve either the quantity or quality of life of breast cancer patients, according to these two studies.  It may shorten survival and it certainly harms the quality of life.

In 2007, this Advisory Committee recommended against approval for Avastin but FDA approved it anyway.

We urge you to set the record straight – send the FDA a clear message that this Committee is putting public health first. It is clear that the benefits do not outweigh the risks and that the indication for treatment of metastic breast cancer should be REMOVED from the Avastin label.

Brandel France de Bravo, MPH, Cancer Prevention and Treatment Fund, March 31, 2010

I am pleased to have the opportunity to testify on behalf of the National Research Center for Women & Families, and its Cancer Prevention and Treatment Fund.  I have a Master’s in Public Health from Columbia University, and in addition to my position at the National Research Center for Women & Families, I am an Associate of the Johns Hopkins Bloomberg School of Public Health in the Department of Health, Behavior & Society.

Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research to determine what is known and not known about specific treatments and prevention strategies.  We do not accept contributions from companies that make medical products or from the tobacco industry.

I should disclose that my mother has stage IV lung cancer but she was never a smoker of menthol cigarettes.

Like most smokers, she began smoking as a teenager. We know from what we heard yesterday that adolescents are more likely to smoke menthol cigarettes than adult smokers. We also know that while smoking is declining among adults and adolescents, menthol cigarettes are becoming more popular among both adults and kids ages 12-17.

Anything that makes smoking more attractive or tolerable in adolescence-whether it’s a flavor or the perception that the models in ads for menthol cigarettes are younger- will only add to our country’s burden of addiction and lung disease, including lung cancer. We know that if kids can get through adolescence without smoking, they stand an excellent chance of never smoking. Dr. Rising shared with us yesterday these facts:  about 90% of smokers tried their first cigarette before 18, and about 70% were smoking daily by age 18.

We also learned yesterday from Dr. Hoffman that menthol smokers-young and old-appear more dependent on cigarettes by many measures than non-menthol smokers. Among 2,000 secondary school kids surveyed in 2006, Black youth scored highest on all the measures of dependence, which included number of cigarettes smoked in their lifetime, number of days per month they smoke; shortest time since last cigarette; and likelihood of being a daily smoker.

We know that African Americans are more likely to smoke menthol cigarettes than any other racial or ethnic group, and that magazines and billboards targeted to African Americans are far more likely to advertise menthol cigarettes than non-menthol cigarettes.

The literature review presented yesterday raised as many questions as it answered. It’s clear that more research needs to be carried out, and members of this committee have suggested many worthwhile topics. As scientists, we’re primed to ask questions and ask that research be done to answer them.  As public health experts, however, I think we can agree on a few things without doing any additional research. Some of our most vulnerable populations, including communities with huge health disparities, appear to be the most susceptible to menthol’s appeal: adolescents, Blacks, Hispanics, and women. And as a result, they will develop lifelong habits that will lead to disease and disability.

As their overall U.S. market declines, cigarette manufacturers have seized on menthol’s competitive advantage, introducing light menthol brands for new and young smokers who prefer that, and stronger menthol cigarettes for the more experienced and older smokers who crave that. Now that all flavors other than menthol have been banned, menthol has become the industry’s last holdout and last hope for disguising the taste of tobacco.

Several studies cited by Dr. Hoffman suggest that part of the problem with menthol is that it masks problems: smokers of menthol cigarettes may not be able to perceive changes in health as readily. A spoonful of sugar makes the medicine go down, but cigarettes aren’t medicine. They are the main cause of lung cancer, the #1 cause of cancer deaths, and they are poisonous to our health. We should not allow companies to sweeten the poison. Industry will try to convince us that the research on the dangers of menthol cigarettes isn’t convincing; there will be pressure to study and stall, but I am here today to beg you: don’t drink the Kool-Aid. Just because it’s cool and refreshing, doesn’t mean it won’t kill you.

We urge you to advise banning menthol cigarettes just as other flavored cigarettes have been banned.

Brandel France de Bravo, MPH, Cancer Prevention and Treatment Fund, March 25, 2010

I am pleased to have the opportunity to testify on behalf of the National Research Center for Women & Families, and its Cancer Prevention and Treatment Fund.  I have a Master’s in Public Health from Columbia University and am an Associate of the Johns Hopkins Bloomberg School of Public Health in the Department of Health, Behavior & Society.

Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research to determine what is known and not known about specific treatments and prevention strategies.  We do not accept contributions from companies that make medical products.

One in ten Americans, including teenagers, visit indoor tanning facilities where they are exposed to UVA and sometimes UVB rays. Both types of UV exposure are known to increase the risk of various types of skin cancer, and last year the World Health Organization’s International Agency for Research on Cancer (IARC) declared tanning beds “carcinogenic to humans.”

Of the 30 million Americans who use tanning devices each year, approximately 2 million are adolescents between the ages of 11 and 18 (Cokkinides et al, Cancer 2009). Adolescent girls are particularly heavy users, with one study reporting that by age 17, as many as 35% of adolescent girls are tanning using FDA-cleared devices (AC Geller et al, Pediatrics, 2002). Research shows that almost all people who use tanning devices use them more often than the FDA’s recommended limits.  So, it’s not surprising that 58% of the teenagers surveyed by Cokkinides et al. reported burns from indoor tanning. And we know that burns, especially when you are young, greatly increase the risk of skin cancer.

Although the FDA’s executive summary mentions how many people are employed in companies that make indoor tanning devices or sell them, those numbers should not influence this advisory committee.  It is irrelevant to your job today, and should be irrelevant to the FDA’s decision.

Currently tanning devices that are not used for dermatologic disorders-the kind of devices used at the tanning salon in the mall-are considered Class I devices. These are devices classified as having the lowest risk to the consumer and include bandages and tongue depressors. Given that tanning devices emit UV radiation and have been labeled carcinogenic by IARC and other leading scientific bodies, it is time that the FDA re-classify these devices.

The question you will need to answer today is:  Should tanning devices be Class II or Class III?  The Patient, Consumer, and Public Health Coalition, of which my organization is a member, recently wrote to Commissioner Hamburg recommending that tanning devices be considered Class III because a device that increases the likelihood of developing the most serious type of skin cancer and that has no real health benefits should be given the highest level of scrutiny by the FDA.  I have brought a copy of that letter for this meeting record. Although UV radiation-regardless of the source-stimulates the skin to synthesize Vitamin D, there are far safer ways to increase your Vitamin D, such as through supplements.

We recommend that the FDA regulate indoor tanning devices as Class III devices and require that they go through the PMA process. Admittedly, it’s difficult to figure out how to conclude that these devices are safe and effective.  They clearly aren’t safe…and what are they effective at? The U.S. does not need innovative new tanning devices unless they are safer than current devices.  The only way to ensure that is through the PMA process.  Clearing tanning devices through the 510(k) process as substantially equivalent to other, equally unsafe tanning devices is not in the interest of public health in the U.S.

Over 250,000 people are diagnosed with non-melanoma skin cancers in the U.S. every year and over 68,000 are diagnosed with melanoma, with 8,000 dying from it every year. The costs of these cancers to our health care system are enormous.  I hope you will advise the FDA not to contribute to this epidemic of cancers by pretending that indoor tanning is risk-free.

In addition to reclassifying tanning devices, we ask that today’s panel consider the following:

1. While tanning facilities tend to rely heavily on UVA rays, many use varying proportions of UVB rays to speed the tanning process (93% to 99% UVA and 7% to 1% UVB). We recommend that a standard be set for the UVA/UVB mix that is the least dangerous, based on the science, while recognizing that NO mix is justifiably safe for a product that has no real benefits. This should apply to all such devices, whether for use by a dermatologist, or use by a tanning salon.

2. Tanning facilities should be required to screen people for skin type and people with a family history of skin cancer.  Fair-skinned people with Skin Type I (unfortunately, these are the  people most likely to use tanning beds) or people with a family history of skin cancer should be told that tanning devices are not approved by FDA for their use.

3. Tanning salons should be required to exclude anyone under 21, as recommended by the American Association of Pediatrics.  If this is not done, we would agree with the American Academy of Dermatology recommendation banning tanning devices for minors.  At the very least, parents should be required to sign an informed consent form in person at the time that the minor is using the tanning facility. Otherwise, these parental consent forms will be forged by the teenagers and will serve no function.

4. Indoor tanning facilities should be required to post prominently displayed, large “black box” warnings in waiting/reception areas and also on or next to the machine itself. These warnings would briefly describe risks and mandated limits on use (time per exposure, amount of UV radiation per exposure, and number of exposures per year).  Customers should be limited to a certain number of visits per year to the same tanning facility or chain of tanning salons.  (It would be preferable but clearly impossible to limit the total number of visits to all salons, since they are unlikely to share customer lists with one another.)

5. Patients should have to sign something indicating that they have read a patient disclosure or a “note of understanding.” This would include the number of tanning sessions per year that is the FDA approved limit, and patients should be able to take home with them an easy-to-understand brochure, written at the 6^th grade reading level, that explains all the risks of indoor tanning as well as skin cancer warning signs.

More than half of all states have passed some type of restriction on the use of tanning beds, particularly when it comes to minors using them. It’s time for the FDA to take the lead and reclassify all tanning devices as Class III devices, requiring approval through the PMA process. It took our country until 1985 to get explicit warnings on cigarette packages about the risk of lung cancer and other diseases. Let’s put prominent warnings on tanning beds before we cost the U.S. more lives and healthcare dollars.

Update 5/29/2014: FDA has new warnings about indoor tanning risks.

Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, February 25, 2010

I am pleased to have the opportunity to testify as president of the National Research Center for Women & Families and our Cancer Prevention and Treatment Fund.

Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research to determine what is known and not known about specific treatments and prevention strategies.  We then translate that complicated information into plain language so that patients, consumers, media, and policy makers will understand it.

We do not accept contributions from companies that make medical products.

In addition, I am a fellow at the University of Pennsylvania Center for Bioethics. Previously, I was on the faculty at Yale and Vassar and conducted research at Harvard, and I was trained in epidemiology at Yale Medical School.  I tell you this because my perspective is as a scientist but my work consists of explaining science to people who don’t have the training I have.  In fact, when we train interns and new staff, the hardest part is getting very smart, well-educated people to write so that the general public understands the health information they need.

The FDA materials we were asked to review look like homework assignments.  They seem as if they were written by people with graduate degrees for people with graduate degrees–or at least smart college grads.  But many Americans don’t go to college, and even high school grads often don’t read at the 12^th grade level.  A lot of people don’t like to read at all, or don’t read well, and you need to make sure they can understand what they need to know.  That’s why it is important to communicate risk information at the 5^th grade or 8^th grade level instead.

Even educated people don’t want to read long, complicated materials–except possibly the most highly motivated people, and even they want to get the meat of the matter, not the extraneous information.  And, also remember that most medications in this country are taken by the elderly, and even those who are highly educated may not be able to read or concentrate as well as they did when they were younger.

Graphics are important, as you know. When the companies you regulate want to get people’s attention, they use TV ads and attractive graphics on print ads.  But whether or not you use great graphics, you can make the materials easier to read by using bold fonts, different size fonts, and more white space.  You can make the materials look more inviting, and less like work.

Overall, the FDA communications you provided to us use:

• sentences that are too long,
• words that are too technical or difficult for many readers, and
• include too many unnecessary details

For example, it isn’t really necessary to include the date when a drug was approved by the FDA, because it doesn’t matter to the patient whether it was November 2004, January 2004, or 2006.  If you think that there are details that might be important to some patients, include it last or in a link.

Here‘s a booklet for breast cancer patients that we wrote with the National Cancer Institute and NIH.

It is geared to an 8^th grade reading level.  Compare that to the materials that the FDA is using, such as the patient booklet that the FDA requires for women who are getting breast implants to help them understand the risks..  That booklet is about 45 pages long, 8.5 x 11″, unattractive and uninviting.  You have to get through half of it to get to some of the crucial risk information.  It’s so long that most women are not going to get past the first page or two.  I think we can all agree that breast implants are not more important or more complicated than breast cancer.  So why the difference between the two booklets?  There is a clear disconnect between what NIH is giving patients and what FDA is giving them, and the NIH is usually doing a better job.  I agree with the panel member who pointed out that the Office of Women’s Health at the FDA is also doing a better job at providing user-friendly information to patients and consumers.

The risk information for LASIK patients is similarly overly long and technical.  It has lots of great information but many patients are just not going to get that far into the booklet.  If we want them to get that information, the materials need to be shortened and made less technical.

I want to take a few minutes to make a few specific comments about the examples you provided for this meeting.  I will focus on the ones for patients.

I agree with what was said about the titles being too long.  “FDA Drug Safety Communication” should not be the beginning of the title.  Shorten that to “FDA Drug Safety Alert,” and make that a separate line, perhaps a logo on the top of the page.

The title “Risk of Progressive Multifocal Leukoencephalopathy (PML) with the Use of Tysabri (natalizumab)” is too long and too hard to read.  Why not call it “Risks of Tysabri (natalizumab)”?  That will get and keep people’s attention so they will want to read it, if they are on the drug or prescribed the drug.

FDA also needs to avoid phrases like “this medication has been associated with this risk.”  Most people don’t know what “has been associated” means.  I understand you can’t or might not want to say “causes this risk,” but you need a verb that has meaning to people.  Perhaps “increases the risk of” or “may cause in some people.”

Regarding the flu vaccine information you provided, why not just call it a “flu vaccine” not an “inactivated Influenza vaccine” or “attenuated influenza vaccine” or a “monovalent vaccine.”  People say “flu” and so should FDA, and most people will not understand or need to know exactly what kind of vaccine it is.

On the vaccine fact sheet that was apparently meant to reassure patients, here’s a typical sentence “Aluminum salts are incorporated into some vaccine formulations as an adjuvant to enhance the immune response in the vaccinated individual.” Who talks like that?  How about: “Aluminum salts are in some vaccines to make them more effective.”

That makes the point in a way that is much easier to understand.

In your previous discussion, there were some concerns about making sure patients know that there is a risk of death, when there is one, but also putting that in the context of other risks in their lives.  I think that numbers, such as “there have been 13 deaths reported in the last 12 years” is not always helpful, because the number of reported deaths may not represent the deaths caused by the product-it could be higher or lower.  And, when people ask their doctors about those numbers, there seems to be a tendency to down play them, especially if the physician hasn’t had a patient who died from that product.  And, for some people, x number of deaths might seem very high and for another it might seem very low.  So, it’s difficult to know how to present that information.

However, when there is a serious risk from a medical product, whether that risk is death or serious harm, I don’t think comparing that to other risks-getting hit by lightening or dying in a car accident, for example-is helpful for most people.  Unfortunately, these risks are cumulative.  All of us who use cars run the risk of having a car accident, for example, and we can lower that risk by driving more carefully, but that risk is always going to be there whether or not we use a medical product with additional risks.  It seems to me the comparison of risk should be to other medical products with the same benefits, or to no treatment at all.  That’s the additional risk posed by that particular medical product, and patients should know if the risk is rare, very rare, or as high as 1 in 100, or 1 out of 10, or whatever it is.

Thank you for the opportunity to share our thoughts with this distinguished panel, and the FDA staff who are working hard to improve FDA’s ability to inform patients and consumers.