Category Archives: news-you-can-use

A Shocking Diagnosis: Breast Implants “Gave Me Cancer”

Medical Treatments with Cancer Risks, News Stories & Editorials, news-you-can-use
Denise Grady, The New York Times: May 14, 2017

Raylene Hollrah was 33, with a young daughter, when she learned she had breast cancer. She made a difficult decision, one she hoped would save her life: She had her breasts removed, underwent grueling chemotherapy and then had reconstructive surgery.

In 2013, six years after her first diagnosis, cancer struck again — not breast cancer, but a rare malignancy of the immune system — caused by the implants used to rebuild her chest.

“My whole world came crumbling down again,” said Ms. Hollrah, now 43, who owns an insurance agency in Hermann, Mo. “I had spent the past six years going to the oncologist every three months trying to keep cancer away, and here was something I had put in my body to try to help me feel more like a woman, and it gave me cancer. I thought, ‘I’m not going to see my kids grow up.’”

Her disease — breast implant-associated anaplastic large-cell lymphoma — is a mysterious cancer that has affected a tiny proportion of the more than 10 million women worldwide who have received implants. Nearly all the cases have been linked to implants with a textured or slightly roughened surface, rather than a smooth covering. Texturing may cause inflammation that leads to cancer. If detected early, the lymphoma is often curable.

The Food and Drug Administration first reported a link between implants and the disease in 2011, and information was added to the products’ labeling. But the added warnings are deeply embedded in a dense list of complications, and no implants have been recalled. The F.D.A. advises women only “to follow their doctor’s recommended actions for monitoring their breast implants,” a spokeswoman said in an email this month.

 Until recently, many doctors had never heard of the disease, and little was known about the women who suddenly received the shocking diagnosis of cancer brought on by implants.

An F.D.A. update in March that linked nine deaths to the implants has helped raise awareness. The agency had received 359 reports of implant-associated lymphoma from around the world, although the actual tally of cases is unknown because the F.D.A.’s monitoring system relies on voluntary reports from doctors or patients. The number is expected to rise as more doctors and pathologists recognize the connection between the implants and the disease.

Women who have had the lymphoma say that the attention is long overdue, that too few women have been informed of the risk and that those with symptoms often face delays and mistakes in diagnosis, and difficulties in receiving proper care. Some have become severely ill.

Implants have become increasingly popular. From 2000 to 2016, the number of breast augmentations in the United States rose 37 percent, and reconstructions after mastectomy rose 39 percent. Annually, nearly 400,000 women in the United States get breast implants, about 300,000 for cosmetic enlargement and about 100,000 for reconstruction after cancer, according to the American Society of Plastic Surgeons. Allergan and Mentor are the major manufacturers. Worldwide, an estimated 1.4 million women got implants in 2015.

As late as 2015, only about 30 percent of plastic surgeons were routinely discussing the cancer with patients, according to Dr. Mark W. Clemens II, a plastic surgeon and an expert on the disease at the University of Texas MD Anderson Cancer Center in Houston.

“I’d like to think that since then we’ve made progress on that,” Dr. Clemens said.

Late last year, an alliance of cancer centers, the National Comprehensive Cancer Network, issued treatment guidelines. Experts agree that the essential first step is to remove the implant and the entire capsule of scar tissue around it. Otherwise, the disease is likely to recur, and the prognosis to worsen.

Not all women have been able to get the recommended treatment. Kimra Rogers, 50, a nursing assistant in Caldwell, Idaho, learned last May that she had lymphoma, from textured implants she had for more than 10 years. But instead of removing the implants and capsules immediately, her doctor prescribed six rounds of chemotherapy and 25 rounds of radiation. A year later, she still has the implants.

“Unfortunately, my doctor didn’t know the first line of defense,” Ms. Rogers said.

She learned about the importance of having the implants removed only from other women in a Facebook group for those with the disease.

Her health insurer, Blue Cross Blue Shield of Montana, covered the chemotherapy and radiation but has refused to pay for removal of the implants, and told her that her appeal rights were “exhausted.” In a statement sent to The New York Times, a spokesman said, “Cosmetic breast implants are a contract exclusion, as are any services related to complications of the cosmetic breast implants, including implant removal and reconstruction.”

Physicians dispute that reasoning, saying the surgery is needed to treat cancer. Her lawyer, Graham Newman, from Columbia, S.C., said he was planning a lawsuit against the implant makers, and had about 20 other clients with breast-implant lymphoma from Australia, Canada, England and the United States.

Ms. Rogers has been unable to work for a year. If she has to pay to have the implants removed, it will mean taking out a $12,000 loan.

“But it’s worth my life,” she said.

Insurers generally cover implants after a mastectomy, but not for cosmetic enlargement, which costs $7,500 or more. Repeat operations for complications are also common, and usually cost more than the original surgery.

Diagnosis and Treatment

Most of the cancers have developed from two to 28 years after implant surgery, with a median of eight. A vast majority occurred with textured implants.

Most implants in the United States are smooth. But for some, including those with teardrop shapes that would look odd if they rotated, texturing is preferable, because tissue can grow into the rough surface and help anchor the implant.

Researchers estimate that in Europe and the United States, one in 30,000 women with textured implants will develop the disease. But in Australia the estimate is higher: one in 10,000 to one in 1,000. No one knows why there is such a discrepancy.

What’s inside the implant — silicone or saline — seems to make no difference: Case numbers have been similar for the two types. The reason for the implants — cosmetic breast enlargement or reconstruction after a mastectomy — makes no difference, either.

Symptoms of the lymphoma usually include painful swelling and fluid buildup around the implant. Sometimes there are lumps in the breast or armpit.

To make a diagnosis, doctors drain fluid from the breast and test it for a substance called CD30, which indicates lymphoma.

The disease is usually treatable and not often fatal. Removing the implant and the entire capsule of scar tissue around it often eliminates the lymphoma. But if the cancer has spread, women need chemotherapy and sometimes radiation.

“In the cases where we have seen bad outcomes, it was usually because they were not treated or there was a major delay in treatment, on the level of years,” Dr. Clemens said. Doctors at MD Anderson have treated 38 cases and have a laboratory dedicated to studying the disease.

About 85 percent of cases can be cured with surgery alone, he said. But he added that in the past, before doctors understood how well surgery worked, many women were given chemotherapy that they probably did not need.

Case reports on the F.D.A. website vary from sketchy to somewhat detailed and rarely include long-term follow-up. Some describe initial diagnoses that were apparently mistaken, including infection and other types of cancer. In some cases, symptoms lasted or recurred for years before the right diagnosis was made.

What exactly causes the disease is not known. One theory is that bacteria may cling to textured implants and form a coating called a biofilm that stirs up the immune system and causes persistent inflammation, which may eventually lead to lymphoma. The idea is medically plausible, because other types of lymphoma stem from certain chronic infections. Professional societies for plastic surgeons recommend special techniques to avoid contamination in the operating room when implants are inserted.

“It could also just be the immune system response to some component of the texturing,” Dr. Clemens said. The rough surface may be irritating or abrasive. Allergan implants seem to be associated with more cases than other types, possibly because they are more deeply textured and have more surface area for bacteria to stick to, he said. Allergan uses a “lost-salt” method that involves rolling an implant in salt to create texture and then washing the salt away. Other makers use a sponge to imprint texturing onto the implant surface.

Allergan is studying bacterial biofilms, and immune and inflammatory responses to breast implants, a spokesman said in an email. He said the company took the disease seriously and was working with professional societies to distribute educational materials about it.

Another possible cause is that some women have a genetic trait that somehow, in the presence of implants, predisposes them to lymphoma. Dr. Clemens said researchers were genetically sequencing 50 patients to look for mutations that might contribute to the disease.

Dr. Clemens was a paid consultant for Allergan from 2013 to 2015, but not for breast implants, and no longer consults for any company, he said.

A spokeswoman for Mentor said the company was monitoring reports about the lymphoma, and stood behind the safety of its implants.

[…]

Read the full article here.

What If Ryan Gets His Wish and Trumpcare Becomes Law

news-you-can-use
Shannon Firth, Washington Correspondent, MedPage Today: March 14, 2017

WASHINGTON — The Republican’s repeal and replace bill, American Health Care Act, cleared two congressional committees and the Congressional Budget Office released its scoring report, Speaker of the House Paul Ryan (R-Wisc) says passing the GOP plan is a make or break issue Congress.

So it is time to ask the pundits: what will happen if this bill becomes law?

MedPage Today asked policy experts on both sides of the great healthcare divide to answer that question and this is what they told us.

From the Pro Repeal and Replace Camp:

Douglas Holtz-Eakin, PhD, president of the American Action Forum touted the bill because it allows people to make their own choice. He predicts that eliminating the individual mandate will mean 5 million fewer uninsured in 2018.

“The bill basically says we respect your decision to not purchase insurance. There’s a public policy decision about how much we respect people’s decisions and clearly we know where the bill comes down on that,” he said. […]

And Now the Loyal Opposition:

Under the Affordable Care Act, the reason everyone pays for all of the various benefits was because doing so lowered costs, explained, Diana Zuckerman, PhD of the National Center for Health Research.

In the same way that car insurance lowers the cost of having an accident when everyone buys it, under this philosophy healthcare also protects everyone who buys it, Zuckerman said.

“Under [the AHCA] it’s a different view. It’s not that view of ‘We’re all in this together,’ and if we all share the cost, we’ll all get good insurance. Instead the view of this plan is every person for themselves. Everybody should get what seems best for them, even though that could result in 24 million not getting any insurance.” […]

Read the full article here.

Trump’s FDA Nominee Spurs Concerns About Drug Approvals, Off-Label Promotion

In the News, News Stories & Editorials, news-you-can-use
Bronwyn Mixter, Bloomberg BNA: March 14, 2017

President Donald Trump’s pick to head the FDA is spurring concerns about drug approvals and off-label promotion.

Trump March 10 nominated Scott Gottlieb to be the commissioner of the Food and Drug Administration. The nomination was widely praised by drug and device industry groups, but a consumer group and other stakeholders told Bloomberg BNA they are concerned that Gottlieb, who is a resident fellow at the American Enterprise Institute and previously worked at the agency as a deputy commissioner, has advocated for quicker drug approvals with less evidence and wants to loosen restrictions on off-label promotion of drugs and medical devices. Critics of the nomination also are concerned that Gottlieb is too closely tied to industry. […]

Gottlieb “is someone who is entangled in an incredible, unprecedented web of ties to industry spanning his professional career,” Public Citizen’s Carome told Bloomberg BNA.

Carome said Gottlieb has been both a venture capitalist and sat on the boards of several drug companies. Gottlieb also “accepted large amounts of money for the period 2012 to 2015, at least $400,000, in speaking fees and consulting fees from several companies and we think it’s just impossible for him to really fully disengage from those ties to industry,” Carome said.

“Like many of President Trump’s other nominees, Scott Gottlieb has extensive financial ties to the industries he’d be in charge of regulating and has shown more interest in reducing regulations rather than enforcing them,” Diana Zuckerman, president of the National Center for Health Research, told Bloomberg BNA in an email.

Zuckerman said “when FDA focuses too heavily on easing the burdens on industry, that shifts the burden to patients, consumers, and physicians” and “none of us can make informed decisions about medical treatments, diagnostics, or prevention strategies when the FDA doesn’t require clear scientific evidence and isn’t transparent about its decisions.”

“If he becomes Commissioner, I hope Dr. Gottlieb will enforce the law and focus on fulfilling the FDA’s essential public health mission,” Zuckerman said. “I expect that industry will strongly support Dr. Gottlieb’s nomination but divesting could potentially be complicated and therefore could delay his confirmation.” […]

Read the full article here.

Less Radical Surgery Is a Healthier Choice for Women with Breast Cancer

Breast Cancer, news-you-can-use,
Brandel France de Bravo, MPH and Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund

Experts have long advised that lumpectomy patients live as long as mastectomy patients.  But the latest research, based on hundreds of thousands of women, indicates that women with DCIS or early-stage breast cancer are more likely to live longer, healthier lives if they choose less radical surgery. And their quality of life will also be better.

Five enormous studies indicate that lumpectomy patients live longer.

In a 2021 study of almost 49,000 Swedish women followed for 6 years after surgery for early-stage breast cancer, the women who underwent lumpectomy with radiation therapy lived longer on average than those who underwent mastectomy with or without radiation therapy. The benefit of lumpectomy was true when diagnosis, other medical problems, social class, and other demographic factors were statistically controlled. [1]

In a study of almost half a million women with breast cancer in one breast, Harvard cancer surgeon Dr Mehra Golshan reported in 2016 that those undergoing double mastectomies did not live longer than women undergoing a mastectomy in only one breast.[2] On average, women who underwent a lumpectomy instead of mastectomy lived longer than women undergoing either a single or double mastectomy for cancer in only one breast.

Similarly, a study of more than 37,000 women, also published in 2016, women with early-stage breast cancer who underwent lumpectomy with radiation were more likely to be alive 10 years later, compared to women who underwent mastectomies.[3] They were also less likely to have died of breast cancer or of other causes. This was true even when age and factors that could influence survival were taken into account.

Dr. Shelly Hwang and her colleagues found similar results in a 2013 study of more than 112,000 California women who had lumpectomies to remove their early-stage breast cancer were more likely to be alive and free of breast cancer 5 years after surgery than women who had mastectomies.[4] The women had been diagnosed between 1990 and 2004 with either Stage 1 or 2 breast cancer. All of them had either a lumpectomy with radiation or a mastectomy. After surgery, their health was monitored for an average of 9 years (the women were all studied for 5-14 years). The women who had a lumpectomy and radiation tended to live longer than the women who had mastectomies, when controlling for age at diagnosis, race, income, education levels, tumor grade or the number of lymph nodes with cancer. Lumpectomy with radiation was especially effective for women who were 50 years and older with hormone-receptor positive tumors: they were 19% less likely to die of any cause during the study than women just like them who had mastectomies. Perhaps more surprising, they were 13% less likely to die of breast cancer than women just like them who had mastectomies.

What about bilateral mastectomies rather than single mastectomies? In a study published in 2014, Dr Allison Kurian and her colleagues at Stanford studied 189,734 California patients diagnosed from 1998 to 2011 with early-stage breast cancer in one breast, ranging from Stage 0 (DCIS) to Stage 3.[5] The study showed that the percentage of women having both breasts when only one breast had cancer (called bilateral mastectomies) increased dramatically, but there was no advantage to that more radical approach.  Instead, the women who underwent lumpectomies (removing only the cancer, not the entire breast) lived longer and were more likely to be alive 10 years after diagnosis compared to women undergoing a mastectomy.  Women who had both breasts surgically removed did not live longer than those undergoing a mastectomy on one breast.

Compared to women in other countries, women in the U.S. who are diagnosed with early-stage breast cancer are more likely to remove both breasts even if only one has cancer. It is not known why bilateral mastectomy provides no medical advantage, but a study of more than 4,000 cancer patients by Dr. Fahima Osman at the University of Toronto indicates that having a healthy breast removed in addition to the breast with cancer increases the chances of medical complications.[7] Removing the healthy breast (“contralateral breast”) doubled the chances of having wound complications in the first month after surgery: from about 3% for women who had only the breast with cancer removed to about 6% for women who also had the healthy breast removed. About 4% of women who had a single mastectomy experienced some kind of complication (not necessarily wound-related) in the 30 days after surgery, compared to 8% of women who had both breasts removed. The risk of cancer in that healthy breast was already less than 1% per year unless the woman has a BRCA gene or some other very high risk factor.[7] Hormone therapy that blocks estrogen, such as aromatase inhibitors or other pills, can further reduce that already low risk.

Quality of Life

The above studies show that women undergoing lumpectomy live longer than those undergoing mastectomy.  But what about their quality of life?  A study of 560 young women with early-stage (stage 0-3) breast cancer published in JAMA Surgery in 2021, found that women who underwent lumpectomies had a better quality of life than women who underwent mastectomies, regardless of whether they had reconstructive surgery. The women were all 40 years old or younger when they were diagnosed, and their quality of life was evaluated an average of 5-6 years after surgery.  Women’s quality of life tended to be lowest for women who had undergone mastectomy with radiation therapy. [6]

Women who are diagnosed with breast cancer sometimes choose more radical treatments than they need in an effort to “do everything possible” to fight the cancer. It is important to know that research on hundreds of thousands of breast cancer patients who completed their treatment show that being physically active, eating healthy foods, and maintaining a healthy weight all are effective ways to help breast cancer patients live longer. [9]

The Bottom Line: These enormous studies of women in the U.S. and other countries make it clear that women with DCIS or early-stage breast cancer (stages 1-3) should undergo surgery to remove only the DCIS lesion or the cancer, not the entire breast. The women who undergo lumpectomy with radiation usually live longer than those who undergo single mastectomy or bilateral mastectomy, with or without radiation. The one study of young women with breast cancer found that although many undergo mastectomy with reconstruction, their quality of life would be better if they underwent lumpectomy instead. In addition, mastectomy patients who have breast implants are more likely to kill themselves compared to mastectomy patients without implants. Unfortunately, the fear of breast cancer and desire to “get rid of the problem” has resulted in too many women undergoing medically unnecessary mastectomies that do more harm than good. Physicians and breast cancer advocacy groups need to make sure that patients understand why lumpectomy with radiation is a better idea.

For a free booklet on treatment options for DCIS, click here.  For a free booklet on treatment options for early-stage breast cancer, click here.

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

References 

    1. de Boniface J, Szulkin R, Johansson ALV. Survival After Breast Conservation vs Mastectomy Adjusted for Comorbidity and Socioeconomic Status: A Swedish National 6-Year Follow-up of 48 986 Women. JAMA Surg. 2021;156(7):628–637. doi:10.1001/jamasurg.2021.1438
    2. Wong, S., Freedman, R., Sagara, Y., Aydogan, F., Barry, W., & Golshan, M. Growing Use of Contralateral Prophylactic Mastectomy Despite no Improvement in Long-term Survival for Invasive Breast Cancer. Annals of Surgery. 2016 March; doi:10.1097/SLA.0000000000001698
    3. Marissa C. van Maaren, et al, “10 year survival after breast-conserving surgery plus radiotherapy compared with mastectomy in early breast cancer in the Netherlands: a population-based study”. Lancet Oncol. 2016 Aug; 17(8): 1158–1170. Published online 2016 Jun 22. doi: 10.1016/S1470-2045(16)30067-5
    4. Hwang ES, et al “Survival after lumpectomy and mastectomy for early stage invasive breast cancer: The effect of age and hormone receptor status” Cancer2013 April 1; 119(7); DOI: 10.1002/cncr.27795.
    5. Kurian, Allison W., Daphne Y. Lichtensztajn, Theresa H. M. Keegan, David O. Nelson, Christina A. Clarke, and Scarlett L. Gomez. “Use of and Mortality After Bilateral Mastectomy Compared With Other Surgical Treatments for Breast Cancer in California, 1998-2011.” The Journal of the American Medical Association2014; 312(9): 902-914. DOI:10.1001/jama.2014.10707
    6. Dominici L, Hu J, Zheng Y, et al. Association of Local Therapy With Quality-of-Life Outcomes in Young Women With Breast Cancer. JAMA Surg. Published online September 01, 2021. doi:10.1001/jamasurg.2021.3758
    7. Osman, Fahima, et al “Increased postoperative complications in bilateral mastectomy patients compared to unilateral mastectomy: an analysis of the NSQIP database.” 2013 Oct; 20(10): 3212–3217. Published online 2013 Jul 12. doi: 10.1245/s10434-013-3116-1
    8. National Cancer Institute. Breast Cancer Treatment (PDQ®). http://www.cancer.gov/cancertopics/pdq/treatment/breast/healthprofessional/page1
    9. Brooks, M (2022) “Lifestyle changes can reduce risk of death after breast cancer.” Medscape. https://www.medscape.com/viewarticle/983131?src=mkm_ret_221113_mscpmrk_BC_monthly&uac=140425SY&impID=4853207

Prophylactic or optional mastectomies

Breast Cancer, Breast Cancer, news-you-can-use
Diana Zuckerman, PhD, and Brandel France de Bravo, MPH

Every year, thousands of women choose to undergo a mastectomy (surgery to remove the breast tissue) when lumpectomy (removal of only a small part of the breast) would be an equally effective option for them. Some women choose a bilateral mastectomy (removal of both breasts, also called a double mastectomy) when there is cancer in only one breast. Even women who do not have breast cancer may undergo mastectomies as a preventive measure because of their high risk of breast cancer, as was the situation with Angelina Jolie. If either one or two breasts without cancer are removed, the surgery is called a “prophylactic mastectomy.”

Helping patients make an informed decision about whether to have a mastectomy is an important aspect of the physician-patient relationship. Unfortunately, many patients are not able to get the information they need from their physicians. A patient who is seriously considering a mastectomy or bilateral mastectomy that is not medically necessary may be basing her decision more on fear than on information. They may benefit from unbiased information, counseling, or from a second opinion before making a final decision.

The purpose of this article is to provide information that patients and family members can use to help them discuss their options with their physicians.

Should I remove one breast or both?

 Women in the U.S. who are diagnosed with early-stage breast cancer sometimes remove both breasts even if only one has cancer.  However, new research indicates that having a healthy breast removed in addition to the breast with cancer increases the chances of medical complications.  Even though removing a healthy breast lowers the risk of getting cancer in that breast in the future, the risk of cancer in that healthy breast was already less than 1% per year unless the woman has a BRCA gene or some other very high risk factor.1 Hormone pills such as tamoxifen or aromatase inhibitors can further reduce that already low risk. In a study of more than 4,000 women, removing the healthy breast (“contralateral breast”) doubled the chances of having wound complications in the first month after surgery: from about 3% for women who had only the breast with cancer removed to about 6% for women who also had the healthy breast removed. About 4% of women who had a single mastectomy experienced some kind of complication (not necessarily wound-related) in the 30 days after surgery, compared to 8% of women who had both breasts removed. Dr. Fahima Osman of the University of Toronto presented these findings at the 2013 meeting of the American Society of Breast Surgeons.2

What if I have a breast cancer gene (BRCA1 and BRCA2)?

Women with known mutations in the BRCA1 and BRCA2 genes have a lifetime risk of breast cancer ranging from 40% to 65% on average, compared to 12% for women in the general population. Women with BRCA1 or BRCA2 mutations often develop breast cancer before age 50 and have a high risk of bilateral breast cancer and ovarian cancer.3 Removing breasts with no sign of cancer is called a prophylactic (preventive) mastectomy. Prophylactic mastectomy and prophylactic oophorectomy (removal of the ovaries) have both been shown to greatly reduce – but not eliminate – the risk of breast cancer in BRCA mutation carriers.3  Among women with strong family histories of breast cancer, individuals of Ashkenazi Jewish descent have an 8 times greater frequency of carrying these mutations in BRCA1 or BRCA2 compared with other women.4

Lumpectomy with radiation therapy is just as effective for preventing same-breast tumor recurrence in breast cancer patients with BRCA mutations as it is for other women. Questions remain, however, about how other adjuvant treatments (such as chemotherapy) affect survival of women with these gene mutations.4

For women with the BRCA1 or BRCA2 genes, it is important to remember that the risk of breast cancer in the next 5 or 10 years is much lower than the lifetime risk of breast cancer. For example, the risk of breast cancer in her 20s is very low, even with BRCA1 (less than 3%) or BRCA2 (approximately 1%). For a 30-year old woman, the risk by age 39 is higher (10% for women with BRCA1 and 8% for BRCA2). For a 40-year-old woman, the risk by age 49 is 16% for women with BRCA1 and 13% for women with BRCA2.4 Although these 10-year risk levels are much higher than for most women, they are much lower than the life-time risk that is so frightening. It is also important to remember that cancer treatments and prevention strategies are improving, so the risks of cancer may decrease and the survival rates are improving.

Is there something I can do other than Prophylactic Mastectomies?

Prophylactic mastectomies can prevent breast cancer, but many women who undergo prophylactic mastectomies would never have developed breast cancer, even without the surgery.  To make an informed decision about whether to undergo a prophylactic mastectomy, women need a clear understanding of the risks and benefits as well as other strategies that also reduce risk.

Tamoxifen and raloxifene have both been shown to reduce the risk of breast cancer for women who have not had cancer but are at greater risk. These drugs can also reduce the risk of breast cancer for women with BRCA1 or BRCA2 mutations.

For women at high risk of breast cancer for any reason, routine screening starting at a young age can be an alternative to prophylactic mastectomy. Options include clinical breast exams, mammograms, ultrasounds, and MRIs. MRIs are much more accurate than mammograms for young women and women with dense breast tissue, and avoid the additional risks associated with radiation — risks that should be avoided by women who already are susceptible to breast cancer. A 2012 study of women with BRCA1/2 mutations who were under 30 years old showed that the increased radiation they were exposed to from early, frequent mammograms increased their risk of breast cancer. Women with the most radiation exposure had the highest risk of breast cancer, compared to other women with the same gene mutations.5 Those risks can be avoided by replacing early mammograms with MRIs instead. However, it is important to note that MRIs used for screening tend to result in overtreatment, including unnecessary biopsies and mastectomies.6

Research indicates that a low-fat diet, weight control, and exercise may reduce the risk of breast cancer for all women, including women at high risk and women who previously were treated for breast cancer.78

What do stakeholders think of FDA’s latest effort to get patients timelier access to devices?

News Stories & Editorials, news-you-can-use
By Michael Williamson, Bloomberg BNA

The FDA April 8 released two final guidance documents that will help provide timely patient access to high-quality, safe and effective medical devices for unmet medical needs, Jeffrey Shuren, the director of the agency’s Center for Devices and Radiological Health, said in a blog posting.

Reaction to the two documents is mixed – pitting industry against some patient advocates.

One guidance document describes the FDA’s Expedited Access Program (EAP), which should “speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions” without compromising the agency’s high standards for safety and effectiveness, Shuren’s blog posting said. The other guidance document outlines the agency’s current policy on balancing premarket and postmarket data collection during FDA review of premarket approval (PMA) applications. In addition, the document addresses whether or not the circumstances when postmarket data collection is appropriate for PMAs meet the criteria for the EAP.

Two stakeholders seemed pleased with the EAP document. The Advanced Medical Technology Association (AdvaMed), “commends the agency for its efforts to explore supplementary review pathways to provide more timely patient access to new technologies for life-threatening or irreversibly debilitating diseases or conditions that addresses an unmet medical need,” Janet Trunzo, the association’s senior executive vice president for technology and regulatory affairs, told me in a April 9 e-mail.

In addition, Ben Moscovitch, officer with the medical device project of the Pew Charitable Trusts, a nonproft policy organization, told me April 9 many of the recommendations his group made on the draft version of the EAP document were included in the final document. For example, he told me that the EAP final guidance document reflects a Pew suggestion from 2014 that the FDA should require the initiation of postmarket trials and completion of those studies within a certain timeframe.

Not everyone is pleased with the guidance, however. The EAP final guidance “is part of a larger problem where the FDA is bowing to pressure from Congress to weaken safeguards that are intended to protect patients from unsafe medical products,” Diana Zuckerman, president of the National Center for Health Research, told me in an April 9 e-mail. She is also president of the Cancer Prevention and Treatment Fund.

See the original article here.

Medicare panel voices doubts about genetic cancer tests

News Stories & Editorials, news-you-can-use
By Virgil Dickson, Modern Healthcare

The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) has expressed little confidence in genetic tests that supposedly predict common cancers. The decision raises doubts about whether the CMS will authorize Medicare coverage for such tests.

“This is such a promising and exciting field, but the excitement is far ahead of the data,” said Diana Zuckerman, a panel member and president of the National Center for Health Research, an advocacy organization. These tests “could be so helpful if only we knew more.”

Specifically, there was a concern among committee members who met Tuesday about the lack of data regarding clinical utility, which indicates if a test result was actually helpful to a consumer.

“The evidence got very thin, very quickly,” said Dr. Beverly Guadagnolo, a panelist and associate professor in the radiation oncology department at the University of Texas.

Industry stakeholders present at the meeting disagreed. “Two hundred-plus labs around the country wouldn’t be doing these tests if they didn’t have clinical utility,” Dr. Jan Nowak, medical director of molecular diagnostics and cytogenetics at NorthShore University HealthSystem, Evanston, Ill., said during public comments.

Another leading concern was to ensure people did not undergo unnecessary chemotherapy. “We need to be on the side of the angels and minimize access to drugs that don’t necessarily need to be given,” said Dr. Josef Fischer, a panelist and professor in the surgery department at Harvard Medical School and Beth Israel Deaconess Medical Center.

The eight-member panel was asked to vote on a scale of 1 to 5 on how confident members were that the tests they were reviewing would actually benefit Medicare beneficiaries by bettering quality of life, helping them avoid inappropriate anti-cancer treatments or death. The tests that were up for consideration claim they help predict the chances of colon, rectum, breast and lung cancers.

Panel member votes were collected and averaged. Most of the tests received an average score under 3, though a test related to breast cancer rated higher at 3.8. Another test meant to find cancerous lung cancer genes scored the lowest at 1.375.

The panelists also were asked to discuss if they would feel more comfortable with a test being used by beneficiaries if it were a laboratory-developed test from a facility certified under the Clinical Laboratory Improvement Amendments or a test that received Food and Drug Administration approval or clearance. Members seemed more comfortable with an FDA-approved test.

It’s unclear what direction the CMS will take moving forward. MEDCAC is generally considered influential, but the agency recently decided to not concur with a committee vote to not recommend Medicare coverage of annual CT scans to detect lung cancer in heavy smokers.

During the meeting, CMS liaison Dr. James Rollins indicated that any future coverage given to these type of tests would need to prove clinical utility. Today, most entities developing these tests focus on proving analytical validity, how accurately a test detects a specific genetic variant, or clinical validity, how well the genetic variant is being analyzed.

See original article here.

Breast implants in France to carry cancer warning: researchers find a ‘clearly established link’

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By Dana Dovey, Medical Daily
March 18, 2015

Following France’s National Cancer Institute finding a “clearly established link” between breast implants and a specific type of cancer, the country will now order all breast implants to come with a cancer warning. This announcement came after 18 cases of anaplastic large cell lymphoma were directly linked to women with silicone breast implants since 2011.

Anaplastic large cell lymphoma (ALCL) is a type of non-Hodgkin’s lymphoma that affects the blood. The link between breast implants and this form of cancer is extremely rare, so French officials have urged women who already have the implants not to remove them, the Daily Mail reported. Given the severity of the cancer in the few women who do develop it, French officials felt it necessary to inform women of all the possible risks associated with the surgery.

ALCL is extremely rare, affecting around one to six in every three million women who undergo breast augmentation, Medical News Today reported. However, a study conducted by researchers from Cambridge University in the UK found that nearly all cases of ALCL in breasts occurred in patients who had undergone breast augmentation, suggesting a link between the two. Although it’s not clear why silicone breast implants can sometimes cause cancer, the Cambridge investigation did shed some light on the mystery.

“It’s becoming clear that implant-related ALCL is a distinct clinical entity in itself,” Dr. Suzanne Turner, lead researcher of the Cambridge study, told Medical News Today. “There are still unanswered questions and only by getting to the bottom of this very rare disease will we be able to find alternative ways to treat it.”

Breast implants are a very popular surgery, with Dr. Diana Zukerman, president of the National Center for Health Research, explaining that in 2013 alone 300,000 American women opted for the operation. Of these women, around 80 percent undergo breast enhancement for cosmetic reasons while a further 20 percent have breast implants following breast cancer.

This is far from the first time that breast implants have been implicated in causing a health hazard. In 2011, French firm PIP caused global hysteria when plastic surgeons reported an abnormal amount of the implants rupture, the Daily Mail reported. It was later found that the firm had been manufacturing these breast implants using industrial grade silicone intended for use in mattresses.

The implants were subsequently found faulty and banned from use. Women who had already received the implants were advised to have them removed, although European health officials found no medical or toxicological evidence to back this advice.

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Candidate to lead FDA has close ties to big pharma

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By Massimo Calabresi, Time

Duke’s Dr. Robert Califf sees closer collaboration between government and industry

Dr. Robert CaliffLast May, Duke University’s Vice Chancellor for clinical research, Dr. Robert Califf, told an audience of executives that the American system for developing drugs and medical devices was in crisis. Using slides [pdf] developed by Duke’s business school, he said the system was too slow and too expensive, and required disruption and transformation. Towards the end of his talk, he put up a slide that identified a key barrier to change: regulation.

Such views are not uncommon in industry, academic research and on Capitol Hill, but they are noteworthy coming from Califf because he could soon be America’s top regulator overseeing the safety and efficacy of the country’s drugs and medical devices. Califf is already set to become deputy commissioner at the Food and Drug Administration (FDA) next month. Now sources familiar with the process tell TIME he is on President Barack Obama’s short list to run the agency following this month’s announcement that its long-serving commissioner, Margaret Hamburg, will step down in March.

The White House declined to comment on pending personnel decisions, but word that Califf is in contention for the top spot at the FDA comes at a key moment. The agency faces potentially dramatic changes this year as Congress prepares to rewrite many of the rules for how drugs and medical devices are reviewed and tested for safety and efficacy. Califf is widely respected in the public and private sectors, but his candidacy is seen by some as a threat to the independence and authority of the FDA, thanks to his views on the need to accelerate change and his deep financial and intellectual ties to the pharmaceutical and medical device industries.

Califf says his salary is contractually underwritten in part by several large pharmaceutical companies, including Merck, Bristol-Myers Squibb, Eli Lilly and Novartis. He also receives as much as $100,000 a year in consulting fees from some of those companies, and from others, according to his 2014 conflict of interest disclosure [pdf]. In an interview with TIME, Califf estimates that less than half of his annual income comes from research money provided by the pharmaceutical industry, though he says he is not certain because he doesn’t tend to distinguish between industry and government research funding. He says he is divesting his holdings in two privately-held pharmaceutical companies he helped get off the ground.

Califf says such collaboration, not just between industry and academia, but with government, too, is the way of the future. “The greatest progress almost certainly will be made by breaking out of insular knowledge bases and collaborating across the different sectors,” Califf says. He says there is “a tension which cannot be avoided between regulating an industry and creating the conditions where the industry can thrive, and the FDA’s got to do both.” He says it would be “useful to have someone [leading the FDA] who understands how companies operate because you’re interacting with them all the time.”

Diana Zuckerman, President of the National Center for Health Research, which advocates for FDA regulatory authority, says such ties “should be of great concern.” Dr. Califf is “a very accomplished, smart physician who’s been an important name in the field,” Zuckerman says, but his “interdependent relationships” raise questions about his “objectivity and distance.” She cites several studiessuggesting the medical products industry uses such ties to influence the behavior and decision making of doctors and researchers, even when the scientists don’t realize it.

The tension over Califf’s collaboration with industry gets to the heart of the future of the FDA at a pivotal moment. While FDA defenders see the collaboration as a threat to its independence, others see close relationships between government, industry and academia as the model for the future. Califf heads a successful and powerful clinical research program, the Duke Translational Medicine Institute, which brings together industry drug researchers, academic scientists and federal regulators to speed drug development and approval. Califf estimates 50-60% of its $320 million in annual research funding comes from industry.

Capitol Hill is considering codifying parts of that collaborative model for the FDA. The powerful Energy and Commerce Committee in the U.S. House of Representatives recently introduced a draft bill called 21stCentury Cures, which would loosen the drug approval and post-market oversight process. Califf says because the bill is still in draft it is too early to pass an overall judgment on it but he says, “I support a lot of the concepts in the bill.”

In the Senate, the Health, Education, Labor and Pensions (HELP) committee has begun work on its own bill, with committee chairman Lamar Alexander declaring, “It takes too long and costs too much to develop medical products.” In a report paving the way for his legislation, Alexander concluded the FDA has grown too large, has fallen behind scientific innovation and threatens American leadership in biomedical innovation. Reform efforts in the Senate may be aided by the support of liberals like Elizabeth Warren who back looser regulations on the medical device industry.

The FDA uses a model for drug testing and oversight largely developed in the early 1960s, with phased trials before drugs and devices are approved for sale to ensure they are safe and effective, and “post-market” studies afterwards to monitor them. Over time, the agency has come to rely on the medical product industry for more than 60% of its budget for post-market monitoring.Accused of regulatory capture by those who see undue industry influence, the FDA has faced attacks from both sides.

That means the FDA has few defenders and will rely heavily on its next commissioner to stand up for it in public and on Capitol Hill. “This is a very dangerous time for the agency,” says Zuckerman of the National Center for Health Research, “It’s under fire in a way that is unprecedented in the last 20 years.”

Califf’s supporters point out that he is among the ten most cited medical authors in America, and that he has spent his career as a clinician helping patients. Regarding the danger of regulators being “captured” by their interactions with industry, Califf says, “The difference between capture and collaboration towards improving human health is a pretty big difference.”

The White House has set no time frame for its decision on Hamburg’s replacement. It has announced the acting commissioner will be Dr. Stephen Ostroff, a scientist and long-time official at the Health and Human Services department, when she steps down in March.

Link to original article here.

Letter to the Editor: "Keep the Medical Device Tax"

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THE NEW YORK TIMES, FEBRUARY 13, 2015

Our research strongly supports your Jan. 30 editorial “No Case for Killing the Medical Device Tax”: Repealing the tax is indeed “a terrible idea” that solves a nonexistent problem. It could result in cutting health care programs that patients rely on.

Thanks to the Affordable Care Act, millions more Americans can now afford medical care that relies on devices like CT scans, cardiac implants or joint replacements. Our nonpartisan research center just released a report indicating that the device industry is thriving in the two years since the tax went into effect.

Stock prices increased an average of 66 percent for the largest United States-based device companies and even more for the smaller ones, much higher than the pharmaceutical companies, Nasdaq or the New York Stock Exchange.

Device companies’ sales and research and development also increased, and profit margins remained very strong. These data are consistent with the Congressional Research Service report that said the benefits of the health care law would help make up for the minimally negative effect of the tax.

Congress intended for industries that would benefit from the health law to help pay for it. The $29 billion raised from the device industry is far less than the amounts raised from other industries that benefit from the law, like drug makers and insurance companies. Why should those industries pay if the device tax is repealed?

Paul Brown, Washington

The writer is government relations manager at the National Center for Health Research.

See original letter here.