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Letter to House Appopriations Chairman and Ranking Member on opposition to cigar exemption

Legislation

To view as a PDF, click here.

May 27, 2014

The Honorable Harold Rogers
Chairman
Committee on Appropriations
United States House of Representatives
Washington, DC 20515

The Honorable Nita Lowey
Ranking Member
Committee on Appropriations
United States House of Representatives
Washington, DC 20515

Dear Chairman Rogers and Ranking Member Lowey:

We are writing to express our strong opposition to any amendment that would exempt any type of cigar from regulation under the Family Smoking Prevention and Tobacco Control Act, P.L. 111-31, or would impede the current rulemaking process the Food and Drug Administration (FDA) has initiated to determine the appropriate level of oversight for tobacco products not currently regulated by the agency. We believe the FDA should retain the authority to regulate all tobacco products, including cigars, and should be permitted to use a science-based process for determining those regulations. Products containing tobacco cause disease and should not be exempted from oversight by the agency.

While the health risks of cigar smoking are not the same as cigarette smoking, cigar smoke is composed of the same toxic and carcinogenic constituents found in cigarette smoke. According to the National Cancer Institute, cigar smoking causes cancer of the oral cavity, larynx, esophagus and lung, and cigar smokers are at increased risk for an aortic aneurysm. Daily cigar smokers, particularly those who inhale, have an increased risk of heart disease and chronic obstructive pulmonary disease (COPD). Cigar smoking is not limited to adults; it is the second most common form of tobacco use among youth. According to national surveys, 17.8 percent of high school boys currently smoke cigars (i.e., large cigars, cigarillos, and small cigars),1 and each day more than 2,700 youth under 18 years old try cigar smoking for the first time. 2 Young adults (e.g., 15.9 percent of 18 to 24 year olds) are also much more likely to be cigar smokers than older adults (e.g., 4.9 percent of 45 to 64 year olds). 3 FDA has just issued a proposed rule to regulate cigars and other unregulated tobacco products. FDA is seeking public comment about whether all cigars should be regulated by FDA or whether “premium cigars” should be exempted from FDA oversight. During this rulemaking process, FDA will need to assess the available science concerning the health risks of smoking cigars and who smokes different kinds of cigars.

We oppose any amendment that would interfere with the current rulemaking process, prevent a science-based decision-making process, and place a broad category of cigars beyond the reach of FDA. An amendment to exclude certain types of cigars would prevent FDA from implementing even basic common-sense rules such as requiring manufacturers to report what ingredients are contained in their products.

With strong bipartisan support, in 2009 Congress gave FDA authority over the manufacture, sale and marketing of all tobacco products. Congress gave the FDA the flexibility to determine the type of regulation that is appropriate for different tobacco products. While the Act immediately applied all of FDA’s new authorities to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, it established a process for the Secretary of Health and Human Services to assert jurisdiction over other tobacco products, including cigars, and determine which requirements are appropriate for the protection of public health. Maintaining FDA’s current authority will ensure that any proposal about cigars is based on science and will be open to participation by all interested parties through Notice and Comment rulemaking.

Our organizations strongly urge you to oppose any amendment to exempt a type of cigar from regulation or impede the current rulemaking process for establishing oversight of currently unregulated tobacco products.

 

Sincerely,

American Academy of Family Physicians
American Academy of Pediatrics
American Association for Cancer Research
American Association for Respiratory Care
American Academy of Otolaryngology—Head and Neck Surgery
American Cancer Society Cancer Action Network
American College of Cardiology
American College of Physicians
American College of Preventive Medicine
American Congress of Obstetricians and Gynecologists
American Dental Association
American Heart Association
American Lung Association
American Medical Association
American Psychological Association
American Public Health Association
American Society of Clinical Oncology
American Thoracic Society
Association of State and Territorial Health Officials
Association of Women’s Health, Obstetric and Neonatal Nurses
Campaign for Tobacco-Free Kids
Cancer Prevention and Treatment Fund
Lung Cancer Alliance
National African American Tobacco Prevention Network
National Association of City and County Health Officials
National Hispanic Medical Association
National Latino Alliance for Health Equity
National Physicians Alliance
Partnership for Prevention
Society for Public Health Education
Society for Research on Nicotine and Tobacco
United Methodist Church, General Board of Church and Society

Alternative to Pap test is approved by F.D.A.

News Stories & Editorials
ANDREW POLLACK, New York Times

APRIL 24, 2014
The Food and Drug Administration on Thursday approved the first alternative to the long-used Pap test as a primary screening method for cervical cancer, in the face of opposition from some women’s groups and health organizations.

The new test, developed by Roche, detects the DNA of the human papilloma virus, which causes almost all cases of cervical cancer, in a sample taken from the cervix. Pap testing involves examining the cervical sample under a microscope to detect abnormalities.

A committee of outside advisers to the F.D.A. unanimously endorsed the Roche test in a meeting last month.

But a coalition of 17 consumer, women’s and health groups opposed the approval, arguing that the new screening method had not been adequately tested and could upend a practice that has successfully prevented cervical cancer for decades.

“This proposed indication for the HPV test would represent an unprecedented and significant shift in clinical practice that would affect millions of women for the majority of their adult lives,” the coalition said in a letter to the F.D.A. earlier this month.

The letter was organized by the Cancer Prevention and Treatment Fund, a research and patient education organization, and signed by the American Public Health Association, Consumers Union, the National Organization for Women and the women’s health education group Our Bodies Ourselves, among others.

A separate letter making similar arguments was sent to the agency earlier this week by a group of doctors and professors.

The F.D.A. said, however, that the evidence was sufficient.

“Roche Diagnostics conducted a well-designed study that provided the F.D.A. with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer,” Alberto Gutierrez, the agency official who oversees diagnostic testing, said in a statement.

In a letter he sent on Thursday to the coalition of opponents, Dr. Gutierrez noted that the agency merely decided if a test was safe and effective for its intended use. It is up to medical societies and other organizations to decide whether and how to use the test. The approval does not mandate use of the HPV test, just makes it another option.

The Society of Gynecologic Oncology, in a statement on Thursday, said it and other organizations were developing an interim guidance document on incorporating primary HPV testing into cervical cancer screening.

Although the group said HPV testing “will provide doctors one more tool to use in cervical cancer screening,” it also acknowledged that the “approval has raised a number of questions.” It said that it was “extremely unlikely that doctors will stop using the Pap any time soon.”

Roche’s Cobas HPV test and HPV tests sold by other companies have been used until now as a follow-up test to help resolve ambiguous Pap results, or together with Pap testing as a primary screening tool.

The new approval would allow the HPV test to be used alone as an initial screen for women 25 and older. Pap testing would be used only in certain cases as a follow-up test.

Studies have shown that HPV testing can result in detection of more precancerous lesions than Pap testing.

However, the virus test could also conceivably lead to more false alarms because presence of the virus does not necessarily mean cancer. Most young women get infected with HPV after they become sexually active, though in many cases their immune systems can clear the virus.

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That is why HPV testing has generally not been used until now in women younger than 30. Opponents of the F.D.A.’s action said approval of HPV testing for women as young as 25 could lead to more young women being sent for unnecessary cervical examinations and biopsies, which in some cases can lead to preterm births or other problems.

Roche has said that it got around that problem because its test specifically detected the two types of the virus that account for 70 percent of the cancers.

Under its proposal, a women testing positive for one of those two types would then go for a cervical examination known as colposcopy. If a woman tested negative for genotypes 16 and 18 but positive for one or more of the other 12 types the test can detect, she would then get a Pap test to see if a colposcopy was warranted.

HPV tests generally cost $80 to $100 while Pap testing costs only $20 to $40, according to Diana Zuckerman, president of the Cancer Prevention and Treatment Fund. Roche said that Medicare paid only about $48 for an HPV test and that when all factors were considered, the difference in cost between HPV and Pap testing was not significant. Pap testing, begun about 60 years ago, has led to a sharp decline in cervical cancer in the United States. But there are still about 12,000 new cases and 4,000 deaths a year, according to the American Cancer Society.

Letter to the Editor: “FDA’s compassionate-use program offers early access without compromising drug trials”

In the News, News Stories & Editorials
WASHINGTON POST, APRIL 24, 2014

The April 22 front-page article “FDA relents in battle against a cruel disease,” about parents urging the Food and Drug Administration to approve a promising drug for Duchenne muscular dystrophy, pulled on the heartstrings. However, there is a better way to get an experimental drug to patients than lowering approval standards.

If the pharmaceutical company is willing, parents who are understandably desperate to help their children can utilize the FDA’s compassionate-use program, which allows a patient with a life-threatening disease to receive an unapproved drug from the company. This provides patients with early access to drugs. If the patients do well, that early access can help products obtain FDA approval.

Paul Brown, Washington

The writer is government relations manager at the National Center for Health Research, Cancer Prevention and Treatment Fund

FDA OKs first-ever DNA alternative to Pap smear

In the News, News Stories & Editorials
BY MATTHEW PERRONE
AP HEALTH WRITER
April 24, 2014

WASHINGTON (AP) — Federal health regulators have cleared a genetic test from Roche as a first-choice screening option for cervical cancer. It was a role previously reserved for the Pap smear, the decades-old mainstay of women’s health.

The Food and Drug Administration approved Roche’s cobas HPV test to detect the human Papillomavirus, or HPV, in women 25 and up. HPV causes nearly all cases of cervical cancer.

Doctors already use such DNA-based tools as a follow-up to confirm Pap test results. But Thursday’s decision means Roche can now market its test as a first-choice option for cervical cancer screening, ahead of the Pap test.

Currently no major medical guidelines recommend HPV testing alone for cervical cancer screening. Dr. David Chelmow of Virginia Commonwealth University said physicians should hold off on using the test until medical societies can provide guidance on some key questions, including how frequently it should be used. Chelmow spoke on behalf of the American College of Obstetrics and Gynecology at the FDA’s meeting to review the test last month.

Roche supported its bid for expanded marketing with study results suggesting genetic testing is more accurate and objective at identifying cancerous growths than the Pap smear, which requires doctors to examine cervical cells under a microscope for signs of cancer. The test detects 14 high-risk forms of HPV that can lead to cervical cancer.

The FDA approval comes despite pushback from public health advocates, who warned regulators that approving the DNA test as an alternative to Pap could lead to confusion, higher costs and overtreatment. More than a dozen patient groups raised those concerns in a letter to the FDA last week. Specifically, they said HPV-only testing could lead to overtreatment of younger women who carry the virus but have little risk of developing actual cancer. Most sexually active young people contract HPV, though their bodies usually eliminate the virus within a few months. Only yearslong infections develop into cancer.

FDA officials said in a statement Thursday that they approved the test because “Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness.” The trial included over 47,000 women who underwent cervical screening using either Pap or HPV screening. The test results were then checked for accuracy against final biopsy results that confirmed whether they actually had cancer.

For decades the Pap test was the only screening option for cervical cancer – and it’s had a remarkably successful track record. The number of cervical cancer cases reported in the U.S. has decreased more than 50 percent in the past 30 years, primarily due to increased Pap screening. Still, an estimated 12,000 cases of cervical cancer are expected to be diagnosed this year, a fact that has spurred development of HPV tests like those from Roche, Qiagen and other test makers. HPV test costs generally cost between $80 and $100, about twice as much as a $40 Pap.

Medical guidelines have been evolving rapidly to try and incorporate both techniques. Under the latest guidelines from the American Cancer Society, a Pap test is recommended every three years for women 21 to 29 years old. Women 30 and older should have both a Pap test and an HPV test every five years, or a Pap test alone every three years. HPV screening is not recommended for women in their 20s because it increases the odds of more invasive testing that can leave the cervix less able to handle pregnancy later in life.

But the FDA approval allows Roche to market its test for women as young as 25. Women who test positive for the most high-risk strains of HPV should be referred for a colposcopy, an invasive test in which doctors view the cervix with a magnifying device and often collect a tissue sample for testing.

Groups including the Cancer Prevention and Treatment Fund, American Medical Women’s Association and Our Bodies Ourselves questioned why the FDA would approve labeling that goes against medical society recommendations.

In its statement approving the test, the FDA staff suggested its decision would not change how doctors use HPV screening.

“It does not change current medical practice guidelines for cervical cancer screening. These guidelines are developed, reviewed and modified by groups other than the FDA,” said Dr. Alberto Gutierrez, who oversees the FDA’s medical testing office.

But patient advocates rejected that reasoning.

“They imply that the FDA approval decision isn’t that important in deciding how this test will be used,” said Diana Zuckerman, president of the Cancer Prevention and Treatment Fund. “By claiming to pass the buck to the experts in the field, FDA is not taking responsibility for the agency’s influential decision to approve the test as a replacement of the Pap smear for women over 25.”

Switzerland-based Roche said in a statement that the FDA approval “is recognition for the value the cobas HPV test provides to physicians and women to make more informed decisions.”

 

DNA alternative to Pap smear sparks medical debate

News Stories & Editorials
Matthew Perrone, AP Health Writer
April 15th, 2014

WASHINGTON (AP) – A high-tech screening tool for cervical cancer is facing pushback from more than a dozen patient groups, who warn that the genetic test could displace a simpler, cheaper and more established mainstay of women’s health: the Pap smear.

The new test from Roche uses DNA to detect the human papillomavirus, or HPV, which causes nearly all cases of cervical cancer. While such technology has been available for years, Roche now wants the FDA to approve its test as a first-choice option for cervical cancer screening, bypassing the decades-old Pap test.

But a number of women’s groups – including the American Medical Women’s Association and Our Bodies Ourselves – warn that moving to a DNA-based testing model would be a “radical shift” in medical practice that could lead to confusion, higher costs and overtreatment.

“It replaces a safe and effective well-established screening tool and regimen that has prevented cervical cancer successfully in the U.S. with a new tool and regimen not proven to work in a large U.S. population,” state the groups in a letter to FDA Commissioner Dr. Margaret Hamburg. The letter, dated Monday, is signed by 17 patient advocacy groups, including Consumers Union, the Cancer Prevention and Treatment Fund and the National Alliance for Hispanic Health.

Chief among the advocates’ concerns is that HPV-only testing could lead to overtreatment of younger women who carry the virus but have little risk of developing actual cancer. Most sexually active young people will contract HPV, though their bodies usually eliminate the virus within a few months. Only years-long infections develop into cancer.

“Unfortunately the HPV test by itself isn’t very useful because so many young women have HPV that will disappear without any treatment,” said Diana Zuckerman of the Cancer Prevention and Treatment Fund. “Having an HPV test without also getting a Pap smear to check for problems is going to scare a lot of women who are not developing cervical cancer.”

An FDA spokeswoman said the agency could not comment on the letter since it deals with a product under review.

For decades the Pap test was the only screening option for cervical cancer – and it’s had a remarkably successful track record. The number of cervical cancer cases reported in the U.S. has decreased more than 50 percent in the past 30 years, primarily due to increased Pap screening. Still, an estimated 12,000 cases of cervical cancer are expected to be diagnosed this year, a fact that has spurred development of genetic tests like the one from Roche and other test makers.

Medical guidelines have been evolving rapidly to try and incorporate both techniques. Under the latest guidelines from the American Cancer Society, a Pap test is recommended every three years for women 21 to 29 years old. Women 30 and older should have both a Pap test and an HPV test every five years, or a Pap test alone every three years. Women who have had an HPV vaccine should still follow screening guidelines.

HPV screening is not recommended for women in their 20s because it increases the odds of more invasive testing that can leave the cervix less able to handle pregnancy later in life.

But Roche is seeking FDA approval to market its test to women age 25 and up.

That approach was endorsed unanimously last month by a panel of FDA advisers who voted 13-0 that Roche’s cobas HPV test appears safe and effective as a first-choice screening tool. The FDA is weighing that recommendation as it considers approval the company’s application.

Despite the overwhelming endorsement, patient advocates say FDA approval would fly in the face of current medical guidelines, none of which recommend testing with HPV alone for younger women. They point out that the U.S. Preventive Services Task Force, which sets federal medical guidelines, gave HPV testing a “D” rating in women under age 30, warning that testing could lead to “unnecessary treatment and the potential for adverse pregnancy outcomes.”

Even physicians who support HPV testing as an important option warn that introducing a DNA-only testing regimen may lead to confusion that disrupts care. The American College of Obstetricians and Gynecologists says many physicians are already confused by the two existing testing options: Pap alone or Pap with HPV testing.

“Introducing a third screening alternative will likely further increase confusion, and the risk to women of getting either over or under screened,” the group said in comments at the FDA meeting last month. The group, which represents 57,000 U.S. obstetricians and gynecologists, did not sign the letter sent to FDA this week.

Finally there is the cost. An HPV test costs between $80 and $100, at least twice as much as a $40 Pap. And under Roche’s proposal, women who test positive for HPV would be referred for colposcopy, a more invasive testing procedure that can cost up to $500.

All these factors have consumer advocates urging the FDA to break from its advisers and deny first-choice status to the Roche test.

“Sometimes the FDA overrules the advisory committee and it’s OK,” said Dr. Susan Wood, a former FDA official who now directors the Jacobs Institute of Women’s Health.

 Article also appears in The Washington Post, ABC News, NBC News, Star Tribune, Business Week, The Washington Times

No more Pap smears?

Cervical Cancer & HPV, In the News, News Stories & Editorials, , ,
By Diana Zuckerman, PhD
2014

If you’re a woman over 21, that headline probably got your attention. After all, who likes Pap smears? Wouldn’t it be great to never need one again?

Well, don’t get too excited because the alternative could be worse, if a Food and Drug Administration (FDA) advisory committee gets its way. The committee proposes replacing Pap smears with an equally invasive but less conclusive test, the HPV test, when women reach the age of 25. And then, if the HPV test indicates the presence of HPV (or human papillomavirus, which is very common in sexually active young women and usually goes away by itself), the committee proposes following up the test with an even more invasive procedure called a colposcopy. Patients describe a colposcopy as being like a Pap smear that takes 20 minutes instead of a few seconds.

The purpose of a Pap smear is to test for abnormal cells in your cervix that could eventually turn into cervical cancer. Two strains of HPV virus are responsible for 70 percent of cervical cancers. It’s very common for sexually active women to be infected with HPV, but usually the body gets rid of the virus within a year or two all on its own. HPV can only cause cancer when it lingers in the body for several years and starts to damage the cervix.

Even if a woman has had an HPV vaccine, she could still potentially develop cervical cancer, so experts advise women to get a Pap smear every three years, starting at age 21 and ending at age 65.  Starting at age 30, women are given the option of asking their doctor to use the same sample for a Pap smear and the test for HPV. If nothing suspicious is found, they can get screened using both tests every five years instead of every three for the Pap smear alone.

Current guidelines recommend that if a woman has an abnormal Pap smear and an HPV test indicating that she has the types of HPV that can cause cervical cancer, she should undergo a colposcopy to see if she needs surgery. Most women get Pap smears to screen for problems, and typically only get an HPV test if their Pap results indicate abnormal cells.

That’s why not many women currently get the HPV test. The company that makes HPV tests would like to sell more of them. So it’s asked the FDA to change the agency’s instructions for using the HPV test to screen healthy women. Instead of an optional use with Pap smears, it wants FDA approval to use the HPV test on its own to screen all healthy women starting at age 25.

Unfortunately, the HPV test by itself isn’t very useful because so many young women have HPV that will disappear without any treatment. Having an HPV test without also getting a Pap smear to check for problems is going to scare a lot of women who are not developing cervical cancer.  Instead of waiting a few months to see if the HPV goes away by itself (which it typically does), the company wants those women to get a colposcopy, which is as painful as a Pap smear but the pain lasts longer and the procedure costs more. And like a Pap smear, the test isn’t always accurate.

Otherwise, it’s a great idea.

We’re not the only ones who believe that the current guidelines should not be changed. The unbiased experts at the U.S. Preventive Services Task Force recommend that the HPV test only be used on women 30 and over, and only in combination with a Pap smear. They point out that if the HPV test is used on younger women, the results can’t distinguish between HPV that would go away on its own and HPV that could cause cancer. This would lead to unnecessary worry for young women and many unnecessary colposcopies.

At an FDA Advisory Committee meeting this month, Anna Mazzucco, PhD, from our staff expressed her concerns about replacing Pap smears with HPV tests. She pointed out that Pap smears provide inexpensive and and effective screening. In fact, the women who get cervical cancer are usually women who did not regularly get Pap smears or follow-up.

Research indicates that the way to save lives is to help women get screened with Pap smears, not to put them through unnecessary follow-up procedures. The American College of Gynecologists—the doctors who do Pap smears, HPV tests, and colposcopies—also expressed concerns about changing current policies, since there is no evidence that the proposed changes would save as many lives.

In addition, we believe that the more expensive and painful procedures would discourage women from getting screened or following up after receiving suspicious results.

What is going on at the FDA? Why are they choosing advisors who ignore the research evidence in favor of a new, unproven screening strategy? The FDA needs advisors who focus on scientific evidence and who make recommendations based on facts, rather than embracing every new “innovation” in health care, regardless of whether it will work.

When the “old ways” are effective, let’s not throw them out unless there is proof that the new, more expensive way is better.

 

A version of this post appeared in Huffington Post and Maria’s Country Kitchen.

FDA warns against procedure to remove uterine fibroids; says it could spread hidden cancer

News Stories & Editorials
BRADY DENNIS, THE WASHINGTON POST
April 17, 2014

The Food and Drug Administration on Thursday took the rare step of urging doctors to stop performing a surgical procedure used on tens of thousands of women each year to remove uterine growths, saying the practice risks spreading hidden cancers within a woman’s body.

The procedure, known as power morcellation, has long been used in laparoscopic operations to remove fibroid tumors from the uterus, or to remove the uterus itself. It involves inserting an electric device into the abdomen and slicing tissue in order to remove it through a small incision. The surgery is far less invasive than traditional abdominal operations.

But the FDA on Thursday agreed with a growing chorus of researchers and clinicians who oppose the procedure, saying that it can recklessly spread undetected cancers throughout the body and make the disease more lethal in the process. The agency is not seeking to ban the practice or the roughly two dozen FDA-approved devices used to perform it, but hospitals and gynecologists are likely to abandon the procedure because of potential liabilities.

The FDA said its analysis determined that an estimated 1 in 350 women who undergo morcellation have an unsuspected form of uterine cancer called uterine sarcoma.

“The existence of the risk is not new,” said William Maisel, chief scientist at the FDA’s Center for Devices and Radiological Health. “What is new is that the magnitude of the risk appears to be higher than was appreciated by the clinical community.”

Maisel acknowledged that the agency was spurred to action — or at least moved more quickly — because of a high-profile campaign waged in recent months by a Massachusetts couple, both doctors, for a moratorium on the practice.

Anesthesiologist Amy Reed, a mother of six who last spring treated Boston Marathon bombing victims as well as one of the suspected bombers, underwent what was supposed to be a routine procedure last fall to end bleeding from fibroids. The procedure spread undetected, cancerous tumor fragments throughout her abdomen. Now she is battling stage-four leiomyosarcoma, a rare and aggressive form of uterine cancer.

Her husband, Hooman Noorchashm, a Harvard-affiliated cardiothoracic surgeon, responded by launching a campaign to ban the widely used procedure. He has e-mailed numerous regulators, doctors and lawmakers, written to medical journals and lobbied hospitals. The couple started a Change.org petition to end the practice.

Noorchashm said Thursday that he appreciated the FDA’s relative speed in addressing the problem. “You don’t even have to be a doctor to recognize that if tissue or a tumor has malignant potential, you should not mince it up inside someone’s body,” he said. “That’s just bad medicine.”

Many women develop uterine fibroids — benign growths that originate in the muscle tissue in the wall of the uterus. Although many fibroids do not cause problems, others can result in frequent urination, prolonged menstrual bleeding and pelvic pain.

Of the more than 500,000 hysterectomies performed in the United States each year, about 11 percent, or more than 50,000, involve morcellation, according to the American Congress of Obstetricians and Gynecologists. Some doctors advocate performing a morcellation only when using an “isolation bag” in an effort to minimize the spread of tissues, but that method is not foolproof, as the bags can break.

“When you consider what the benefit is, which is a shorter hospital stay and less pain, then consider what the risk is — this could kill you — most women would not choose that risk if they really understood what is at stake,” said Diana Zuckerman, president of the Cancer Prevention and Treatment Fund.

Even before Thursday’s announcement by the FDA, the push to limit uterine morcellations had gained traction.

In February, Temple University Hospital issued guidelines instructing surgeons not to perform the procedure on fibroids over a certain size. Doctors may use the procedure for smaller fibroids only after informing patients about the risks and, in most cases, using isolation bags. Even before that, prompted by Noorchashm’s campaign, Massachusetts General Hospital and Brigham and Women’s Hospital in Boston took similar measures.

On Thursday, the heads of obstetrics and gynecology at both Boston hospitals promptly notified their staffs to suspend use of power morcellation until further notice.
Margaret Jacobson, the medical director of Whatcom Hospice in Bellingham, Wash., cried upon hearing of FDA’s action on Thursday.

In March 2012, her sister, Elizabeth Jacobson, had a hysterectomy by morcellation. Elizabeth Jacobson did not want to miss much work, and the promise of a minimally invasive procedure appealed to her.

But inside the large fibroid that a doctor shredded lurked malignant cells that spread throughout her abdomen, her sister said. Soon, Elizabeth Jacobson was diagnosed with aggressive uterine cancer. She then had a second surgery, rounds of chemotherapy and long stretches of misery. She died Jan. 8, 2013.

“She suffered terribly,” Margaret Jacobson said. “It devastated our family.”
Thursday’s news brought a measure of relief, she said, that other women might avoid the same fate, especially given that safer surgical alternatives already exist.
“It’s a victory ,” Jacobson said. “It’s not okay to tolerate these deaths. . . . My sister’s life was extraordinary; she was beautiful and loving. She does not deserve to be an easily dismissed statistic.”

FDA advises halt of common uterine fibroid procedure citing cancer risks, overseer urges stop in use of morcellators to remove uterine growths

News Stories & Editorials
JON KAMP AND JENNIFER LEVITZ, WALL STREET JOURNAL
April 17, 2014
The U.S. Food and Drug Administration on Thursday advised doctors to stop using power morcellators in women’s abdomens to remove uterine growths called fibroids, citing the risk of spreading cancer.The popular devices—which typically use a tube-shaped blade to grind up and remove fibroids or the entire uterus to avoid the long surgical scars associated with traditional, open surgery—can also spread an often undetectable cancer known as a uterine sarcoma. In a rare safety alert for medical devices, the FDA cited estimates that this cancer affects one in 350 women undergoing such procedures and can significantly worsen the odds of long-term survival.”For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids,” the agency said in a safety communication posted on its website Thursday. Myomectomy is the removal of just fibroids.”In general, the procedure should not be performed,” Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said Thursday at a media briefing.If doctors do perform such procedures, the FDA said, they should advise patients of the cancer-spreading risk.The safety alert was addressed to doctors, medical associations, hospitals, women, device manufacturers and advocacy groups. The FDA’s alert follows a series of Wall Street Journal articles, starting in December, which documented the risk of spreading cancer and a campaign by two Boston-area physicians to halt the procedures.

Amy Reed, a 41-year-old mother of six and anesthesiologist at Boston’s Beth Israel Deaconess Medical Center, developed advanced uterine cancer shortly after a routine hysterectomy in October. The hospital where she was treated, Brigham and Women’s Hospital, acknowledge that use of morcellation worsened her cancer.

The FDA began its review in December, “when some high-profile cases covered in the media came to our attention,” Dr. Maisel said.

The FDA’s alert triggered immediate action on Thursday. Dr. Isaac Schiff, the chief of the Department of Obstetrics & Gynecology at Massachusetts General Hospital, said, “I have asked our doctors to stop the procedure immediately until we have more information.”

The FDA’s move could change the way many women are treated for symptomatic fibroids, which are common but often painful growths that spur about 40% of the roughly half-million hysterectomies performed in the U.S. each year, by some estimates.

Morcellators, first introduced in the 1990s, have helped gynecologists perform about 50,000 of these procedures each year through tiny holes, rather than longer incisions that can lead to bigger scars and a longer recovery.

Diana Zuckerman, president of the nonprofit National Research Center for Women & Families, and an advocate for stiffer medical device regulations, said the FDA’s statement should have a major impact. Going against the FDA’s recommendation could increase doctor’s liability if there are mishaps, she said.

“What surgeon is going to take the chance of using this device if they FDA has made such a strong warning?” she said. The FDA’s action “is going to save a lot of lives.”

Dr. Maisel said the clinical community has been aware of the risk of cancer since the advent of the procedure, although he said the rate of that risk is only now coming into focus. He also said it’s conceivable that some patients may believe the risks of alternative procedures outweigh the risks of laparoscopic surgery with morcellation. They should be explicitly told of the risks, he said.

With the issue gaining steam since December, gynecological societies had already been doing their own reviews of power morcellation. Commenting on the FDA move on Thursday, the American College of Obstetricians and Gynecologists said its own review, which includes an assessment of risks for various groups of patients, is ongoing. “We greatly appreciate the urgency behind the issue,” the group said.

Dr. Maisel said older women have a higher risk of having a hidden sarcoma than younger women.

Many gynecologists have argued there are other ways to perform these procedures without cutting up tissue in the open abdomen, including performing vaginal procedures or cutting tissue manually and inside protective bags.

Gynecologists have acknowledged they seldom used these bags during hysterectomies and fibroid procedures previously. But a number of top hospitals, including Brigham and Women’s and Massachusetts General, have recently told their doctors to only morcellate inside such bags for added protection.

The FDA noted these changes, although Dr. Maisel also said bags have some downside, including obscuring surgeons’ view during procedures, and are “not a panacea.”

The FDA on Thursday said it will convene a public advisory committee meeting this summer to discuss whether such bags can enhance the effective use of morcellators, amid other issues. The agency instructed manufacturers “to review their current product labeling for accurate risk information for patients and providers.”

The FDA recommended “routine follow-up” with physicians for women who have already had hysterectomies or myomectomies, don’t have symptoms and were told post-surgery tests were normal. Tissue is commonly checked for cancer afterward. But women with “persistent or recurrent symptoms or questions should consult their health-care provider,” the agency said.

Statement of Dr. Diana Zuckerman, President, Cancer Prevention and Treatment Fund, regarding FDA’s announcement about power morcellation devices for uterine fibroids and other uterine surgery

In the News, Press Releases
April 17, 2014

The FDA has saved lives today by announcing that they discourage surgeons using an FDA-approved device called a power morcellation device to remove the uterus or uterine fibroids.

This announcement is the result of excellent media coverage explaining that when uterine fibroids contain undiagnosed cancer, the use of power morcellation during laproscopic surgery  can spread the cancer.  The result is that a small contained cancer can spread and become a stage 4, fatal cancer.

This example indicates several major flaws in the system intended to protect patients from unsafe medical products and procedures:

  1. FDA standards for approving medical devices is much too low, resulting in unsafe devices such as the power morcellation.
  2. While many patients have been irreparably harmed by power morcellation devices that spread their undiagnosed cancer, surgeons and other health professionals rarely reported when that happened.  The voluntary system of reporting serious medical harm from devices, including deaths, is not working because most physicians are not reporting most incidents, regardless of how serious they are.
  3. The FDA apparently hardly noticed the problems with power morcellation until two Boston physicians, Amy J. Reed and her husband, Dr. Hooman Noorchashm, became outspoken advocates against it in the media.  Dr. Reed was diagnosed with a rare uterine cancer as a result of morcellation of what was thought to be a benign fibroid, and she and her husband have used their medical connections and the media to try to prevent that from happening to any other women.  We thank them for their courage in speaking out and our prayers are with them.

The FDA needs to do more to prevent these and similar tragedies due to inadequately tested medical products that too often are used by physicians who are inadequately trained to use them safely.  And patients need to be better informed of the risks of medical procedures, not just of the possible benefits.

To read a recent medical journal article on power morcellation, see http://jama.jamanetwork.com/article.aspx?articleid=1828692

BRCA1 and BRCA2 mutations: when your genes increase your cancer risk

Breast Cancer, Breast Cancer, Ovarian Cancer, Prevention
Laurén A. Doamekpor, MPH

When Angelina Jolie announced that she had removed both of her healthy breasts to reduce her risk of breast cancer, she explained that she had inherited the BRCA1 gene mutation, which increases her chances of someday developing breast cancer. This is why she decided to have a preventive (or prophylactic) double mastectomy. Angelina’s public decision drew attention to women with BRCA1 and BRCA2 mutations and the choices they make. Click here to read our response to Angelina’s double mastectomy, published in the Huffington Post.

BRCA1 and BRCA2 gene mutations also increase a woman’s chances of having ovarian cancer. Ms. Jolie has not yet had her ovaries removed.

What are BRCA1 and BRCA2?

BRCA1 and BRCA2 are human genes that produce proteins that suppress tumors and repair damage to our DNA. If there is a mutation in one of these genes and they do not work properly, DNA damage may not be repaired. This can eventually cause cancer.

If you have a BRCA1 or BRCA2 mutation, what are the chances of getting breast or ovarian cancer?

Women who have no family history of breast cancer and don’t carry the BRCA1 or 2 gene mutation, have only a 12% chance of getting breast cancer in their lifetime.4 But women with BRCA1 have about a 55% to 65% chance of developing it by the time they turn 70; the likelihood is a little lower for women with BRCA2 at 45%.5 6

Even though women with BRCA1 or BRCA2 are about 5 times more likely to get breast cancer than the average woman, women with these mutations make up only 5% to 10% of all breast cancer cases. In other words, fewer than 1 in 10 women with breast cancer have either BRCA1 or BRCA2.7

Ovarian cancer is less common than breast cancer. Fewer than 2% of women who have neither BRCA1 or BRCA2, nor a family history of ovarian cancer, will develop ovarian cancer. But, 39% of women with BRCA1 will develop ovarian cancer by age 70, and approximately 11%-17% with BRCA2 will develop ovarian cancer by 70.2 3

Doctors will often suggest testing for the BRCA1 and BRCA2 genes in women with family members diagnosed with breast or ovarian cancer before age 50, family members with cancer in both breasts or multiple breast cancers, and women who come from Ashkenazi Jewish backgrounds.

If you have BRCA1 and BRCA2, what can you do to lower your risk for breast or ovarian cancer?

If you find out that you have the BRCA1 or BRCA2 mutation, it doesn’t mean you will definitely get breast or ovarian cancer.

There are a few ways you can lower your risk of breast cancer:

1) More frequent breast exams to detect cancer as early as possible. Some experts recommend that women with BRCA1 or BRCA2 begin breast cancer screening as early as age 25 4, but that doesn’t mean mammograms should start at such an early age. Young women with BRCA mutations should get screened using magnetic resonance imaging (MRI). MRIs are more accurate than mammograms for young women and do not expose breasts to as much radiation as mammograms do. While early screening can be helpful, if a woman’s genes place her at higher risk, she needs to realize that regular radiation to the breasts at an early age could increase her risk of cancer.

2) Take an estrogen-blocking pill such as tamoxifen. Many breast cancers feed off the estrogen produced naturally by a woman’s body so interrupting the production and flow of estrogen can reduce a woman’s risk of getting breast cancer. Taking tamoxifen after being treated for breast cancer, for instance, usually cuts the risk of breast cancer recurring by about half. However, the effectiveness of raloxifene or tamoxifen in women with BRCA1 and BRCA2 has not been studied specifically yet. 4

3) Preventive mastectomy (removal of the breasts). When a woman with BRCA1 or BRCA2 gets both of her breasts surgically removed, she reduces her chances of getting breast cancer by as much as 95%.8 Why is there still some risk? Because some breast tissue is left behind after surgery, and cancer can develop in that tissue or on the nearby chest wall.9

4) The removal of both ovaries and the fallopian tubes, called salpingo-oophorectomy. The ovaries produce estrogen which make the more common breast cancers more likely to grow, so removing the ovaries and fallopian tubes works much like tamoxifen. Research shows that women with BRCA1 or BRCA2 can reduce their breast cancer risk up to 50% by removing just their ovaries. 5 Removing the ovaries and fallopian tubes is the only known method of reducing the risk of ovarian cancer.

What about having children? While having children reduces the chances of developing the most common types of breast cancer, research published in 2014 found that women with BRCA1 or BRCA2 mutations who decide not to have children are no more likely to develop breast cancer than women with the mutations who do have children. For women with BRCA1 who want to have children, it’s helpful to know waiting until after 30 to have a child and breastfeeding longer—for at least 1-2 years—seems to lower their risk of breast cancer. Delayed childbearing and longer breastfeeding did nothing to lower breast cancer risk among women with BRCA2, however.10

Maintaining a healthy weight and exercising regularly can reduce the chances of breast and ovarian cancer. For women with BRCA1 or BRCA2, some studies show that women who were overweight (BMI>25) at age 18 and lose at least 10 lbs between age 18 and 30 are less likely to develop early-onset breast cancers.11

What women with BRCA 1 and BRCA2 can do to reduce their risk of ovarian cancer

Other than getting a salpingo—oophorectomy (removing the ovaries and fallopian tubes), which can reduce a woman’s risk of ovarian cancer by 90% 12, there is little else a woman with BRCA mutations can do to lower her risk of ovarian cancer. Even after having her ovaries removed, a woman with BRCA mutations will still have a small chance of getting ovarian cancer in the peritoneum (a thin layer of tissue that lines the inside of the abdomen). This can happen if some ovarian tissue is left behind after surgery or if ovarian cancer cells have already spread to that part of the body before surgery.13

The drawback to getting your ovaries and fallopian tubes surgically removed is that you won’t be able to have children naturally and will have to adopt or use some form of assisted reproductive technology like IVF with frozen embryos or frozen eggs. Moreover, studies show that women who have had their ovaries removed are more likely to suffer heart disease, stroke, lung cancer, and depression or anxiety disorders. And the risk of these illnesses is higher the younger the woman is when her ovaries are taken out. Also, if a woman has her ovaries removed before going through menopause, the surgery will cause a sudden drop in estrogen and bring on early menopause.14

There is no widely accepted screening to detect ovarian cancer early. In fact, the U.S Preventative Services Tasks Force recommends against yearly screenings for ovarian cancer in women except those with BRCA1, BRCA2 or a family history of ovarian cancer. Some medical groups recommend transvaginal ultrasound examinations and the CA-125 blood test. But research shows that these screening tools are not very accurate and do not reduce a woman’s chances of dying from ovarian cancer.

Bottom Line

For any woman—whether she is a BRCA carrier or not–maintaining a healthy weight and exercising regularly can reduce the chances of breast and ovarian cancer. You can learn more about ovarian cancer here and more about the risks and benefits of preventive mastectomies to reduce the risk of breast cancer here.

There are other ways women with BRCA1 or BRCA2 mutations can lower their risk of breast and ovarian cancer, such as screening to detect cancer early, surgery to remove breasts, ovaries, and fallopian tubes, estrogen-blocking drugs, and losing weight if they are overweight. While screening regularly for breast cancer with MRIs is safe, surgery and drugs have side effects and risks. Women with the BRCA mutations will want to consult with several different doctors to discuss what is important to them at each phase of their reproductive lives, and weigh the risks and benefits of each prevention strategy.