Category Archives: News Stories & Editorials

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.

F.D.A. panel recommends replacement for the Pap test

In the News, News Stories & Editorials
BY ANDREW POLLACK, THE NEW YORK TIMES
MARCH 12, 2014

The Pap test, a ritual for women that has been the mainstay of cervical cancer prevention for 60 years, may be about to play a less crucial role.

A federal advisory committee recommended unanimously on Wednesday that a DNA test developed by Roche be approved for use as a primary screening tool.

“Has our Pap, as we know it, outlived its time?” Dr. Dorothy Rosenthal, a professor at Johns Hopkins University, testified to the committee, which advises the Food and Drug Administration. She said deaths from cervical cancer in the United States had stopped declining and that there would be “a tremendous gain” by moving to the new test.

The Roche test detects the DNA of human papillomavirus, or HPV, which causes almost all cases of cervical cancer. Pap testing involves examining a cervical sample under the microscope looking for abnormalities.

Until now HPV testing has been used mainly as a follow-up test when the Pap results were ambiguous, or used jointly with Pap testing.

Wednesday’s 13-to-0 vote — by a committee mainly of academic pathologists, microbiologists and gynecologists — would allow Roche’s test to be used alone as the initial test for women 25 and older.

The Roche test is seen as better than Pap tests in finding precancerous lesions.

The Pap test, which is well entrenched and has been highly successful, will not go away quickly, if at all, however.

Assuming the F.D.A. itself agrees with its advisory committee and approves the new use of Roche’s test, it would become just another option, not a replacement for the older testing regimens. And many doctors will not adopt the new test unless professional societies recommend it in guidelines, which could take years.

Use as a primary screening tool could mean much wider sales of HPV tests. The United States market for such tests is more than $200 million, according to DeciBio, a market research firm.

Qiagen is the leading seller of such tests, with Roche and Hologic and BD also participating. Various laboratories also offer their own tests. But the approval as a primary screening tool would be only for Roche’s Cobas test, which could help it gain market share.

Current United States guidelines recommend that women 30 to 65 undergo either co-testing with both HPV and Pap every five years, or Pap testing alone every three years. Women 21 to 30 are supposed to have Pap testing every three years.

The American Cancer Society estimates that about 12,360 new cases of invasive cervical cancer will be diagnosed in 2014 and about 4,020 women will die from the disease. Between 1955 and 1992, the cervical cancer death rate declined by almost 70 percent, mainly because of Pap testing. The death rate has remained stable in recent years.

HPV testing has advantages over the Pap test. Studies have shown it is much more sensitive in detecting precancerous lesions. Proponents say it is more objective, its results varying less from lab to lab than those of the Pap tests, which rely on the judgments of people viewing slides under a microscope.

The main drawback of HPV testing is that most people get infected with the virus after they become sexually active, although in most cases their immune systems can clear the virus. So many women, particularly young women, would be sent for additional examinations or biopsies that might not be necessary. That is why co-testing with both HPV and Pap is recommended only for women 30 and over.

Roche says it sidesteps that problem because its test specifically detects two subtypes of the virus, known as genotypes 16 and 18, that account for 70 percent of the cancer cases.

In its study, Roche showed that its test outperformed Pap testing alone in various measures, like the ability to detect precancerous lesions. A negative result on the HPV test was also a better predictor than a negative Pap test that a woman would remain free of lesions for the next three years.

Most people who testified to the committee, which met in College Park, Md., urged approval, some saying it was time to move to modern molecular science.

“George Papanicolaou did not know about HPV,” said Lee Shulman, a professor at Northwestern University, referring to the initial developer of the Pap test. He compared replacing Pap smears with HPV testing to the transition from the horse to the automobile.

But there were objectors who said the data was not sufficient to justify such a change.

“The proposed indication represents a radical shift in clinical practice which would affect millions of women for most of their adult lives,” said Anna E. Mazzucco of the Cancer Prevention and Treatment Fund, a patient support and advocacy group.

She said that most cases of cervical cancer were in women who did not undergo screening, not in those whose disease was missed by screening.

While the committee vote was unanimous, some members had reservations about using HPV testing for women under 30. Some said that HPV testing may not be much better, if at all, than the currently recommended use of both tests.

“I think women are going to be well served by having more choices, but it’s going to be very interesting to watch over the next several years as this rolls out,” said Dr. Alan G. Waxman, a professor of obstetrics and gynecology at the University of New Mexico.

The worst new drug of 2014

In the News, News Stories & Editorials, , , ,
DIANA ZUCKERMAN, PHD, PRESIDENT OF The Cancer Prevention & Treatment Fund 

It’s only February, so it may seem early to be talking about one of the Food and Drug Administration’s (FDA’s) worst decisions of 2014. Yes, the year just started, but the FDA has already made a decision that could potentially harm thousands of patients.

The agency just approved a new diabetes medication that doesn’t noticeably improve health but may in fact cause cancer.

It’s called Farxiga (Dapagliflozin) and it will be available—and probably widely advertised—very soon. The good news is that the drug lowers blood sugar, which is a major symptom of type 2 diabetes. However, lowering blood sugar is not necessarily a way to improve health. The new drug is meant to reduce medical problems such as heart disease or kidney damage. Unfortunately, there is no evidence that it actually improves health—in fact, quite the opposite.

The FDA reports that the most common side effects of Farxiga are genital fungal infections and urinary tract infections. Not fun, but those aren’t its most serious side effects. If a patient has moderate or severe kidney damage (as many diabetics do), the drug is not beneficial and could cause further damage, possibly even renal failure.

But the more frightening news is that patients taking Farxiga in studies done for the FDA were more than five times more likely to contract bladder cancer than the patients who took an older diabetes drug. Based on the findings of the companies making and selling Farxiga, FDA scientists concluded that the drug might stimulate bladder cancer in patients already at risk. The fear is that patients take diabetes drugs for years, and the longer someone takes this drug, the greater their risk of cancer.

Bladder cancer can be fatal, and is especially dangerous in people who have diabetes.

The companies’ studies also found that patients taking the drug were more than twice as likely to get breast cancer as diabetics not taking the drug, but they say this could have happened by chance.

It’s important to mention that only a small number of African Americans were studied. Because African Americans are more likely to have diabetes than Caucasians, these studies should have included greater numbers of them to find out if the drug is safe or effective for them.

With so many other diabetes drugs already on the market, why would anyone want to take this drug, and why would FDA approve it?  Here’s the scorecard, based on information provided by FDA scientists and available on the FDA website:

  1. Is the drug new? Yes.
  2. Does it reduce the medical problems caused by type 2 diabetes, such as blindness, heart disease, kidney damage, or amputations? No.
  3. Can it cause kidney damage or make it worse? Yes.
  4. Does research show that patients taking it are more likely to get bladder cancer. Probably.
  5. Does research show that patients taking it are more likely to develop breast cancer? Maybe.
  6. Does research show it is more effective than most diabetes drugs on the market? No.
  7. Will it cost more than most other diabetes drugs on the market? No information on cost yet, but new drugs usually do cost more.

The FDA is requiring that the label for the drug warn patients with bladder cancer that they shouldn’t take Farxiga because it might make their cancer worse. Ya think? And, the agency is requiring the companies to study 17,000 diabetes patients for at least four years to determine whether and how often patients taking Farxiga are diagnosed with cancer, liver problems, or heart disease when the drug is taken for a longer period of time.

The FDA rejected this drug two years ago because of these cancer concerns and questions about how well the drug prevents the major risks of diabetes. But the FDA has been beaten up by many complaining congressmen since then, and by some patient groups, pushing it to approve more new drugs quickly rather than waiting for safety studies to be completed. Also, the pharmaceutical companies don’t like to take no for an answer, they spend lots of money on lobbying, and they are very effective at pushing FDA to reconsider rejections. Because of that, the FDA selected an advisory committee to review the data in December, and those doctors and scientists also expressed concerns about risks and benefits. I was at the meeting and pointed out that there were too many serious unanswered questions.

Despite my concerns, the concerns of FDA scientists and other experts, and the concerns of the advisory committee members themselves, the committee recommended that if the companies continued to study the drug after it was approved, in order to figure out what the actual risks are, the company could sell it now.

It’s too early to say whether this will be the worst decision the FDA makes in 2014. Maybe the diabetes patients who take it will be lucky and not be harmed by the drug. Or maybe only a few patients will develop cancer or kidney failure as a result of taking it. Or the FDA scientists who expressed their concerns could be wrong, and I could have made a mistake when I agreed with them. But regardless of what happens with this drug, it still would be a bad decision to allow the sale of a drug with such serious (potentially fatal) unanswered questions.

Given the epidemic of diabetes in this country, the risks are huge. For that reason, this drug worries me even more than some of FDA’s similarly mind-boggling decisions of 2013, such as:

  • A drug for hot flashes that has no meaningful benefits but can increase the risk of suicide among women who weren’t depressed
  • An antibiotic for pneumonia that seems to kill more patients than other antibiotics

I’ve always respected the scientists at the FDA for working so hard to try to keep all of us safe. I still do. But decisions are being made at the agency that seem to ignore scientists and science, and that is dangerous for all of us. Whether we have diabetes, hot flashes, pneumonia, cancer, or any other disease, we deserve better.

 

A version of this post appeared in The Huffington Post, Maria’s Farm Country Kitchen

 In 2018, the U.S. Food and Drug Administration (FDA) announced a new warning on Farxiga and other SGLT2 inhibitors because they can cause a rare but life-threatening infection of the genitals and area around the genitals. The infection is called necrotizing fasciitis of the perineum or Fournier’s gangrene.  

Clinical evidence in FDA drug approvals varies widely, study finds

News Stories & Editorials,
by Sabriya Rice, Modern Healthcare
January 21, 2014

Not every new drug approved by the U.S. Food and Drug Administration has undergone the rigorous clinical testing that physicians and their patients might expect, according to new research.

A study published Tuesday in the Journal of the American Medical Association finds that the FDA has “flexible standards” for approving of new therapies. Using publicly available information from the FDA drug database, investigators identified 188 novel therapies for treating 206 conditions approved between 2005 and 2012. Of these, 37% were approved on the basis of a single clinical trial, 38% on the basis of two trials and 25% had been tested in three or more trials.

Although most therapies were supported by at least one randomized, double-blind trial—the gold standard for clinical research—there was wide variation in the duration, size and completion rates. Comparative-effectiveness data was available for less than half of the indications.The purpose of the study, according to its authors, was not to suggest that the FDA is not rigorous in its approach to drug reviews. The regulatory flexibility allows for a customized approach, and the agency can rapidly approve potentially effective therapies for life-threatening diseases and those for which there is no existing, effective treatment, such as orphan diseases, said Dr. Joseph Ross, assistant professor of general internal medicine at Yale University School of Medicine and one of the study authors.

According to Ross, the drug approval variability is problematic in the sense that both patients and physicians feel the research is the same across all drugs approved.

The FDA, in a statement responding to the findings, explained that drugs may be tested in clinical trials that enroll hundreds of participants, while others, particularly those seeking to treat rare diseases, may be tested in trials that enroll only a handful of participants. “In all cases, however, the statutory standards of safety and efficacy must be met in order for the drugs to be marketed in the United States,” the agency said.

Whether or not the process has become too lenient has become a topic of debate among advocates.

The Progressive Policy Institute, a center-left think tank, acknowledged in a policy brief (PDF) that the FDA must strike a difficult balance. “If it is too lenient, (the FDA) will allow the sale of drugs and medical technology that could harm vulnerable Americans. Too tight, and the U.S. is being deprived of key innovations that could cut costs, increase health, and create jobs.”

Some argue, however, that physicians don’t have time to sift through statistical data on every new drug approved, and when they do, there is little information to choose from as they make decisions about the safety of new therapies.

“With new drugs, there is often an exaggeration of the benefits and underreporting of the risks,” said Diana Zuckerman, president of the National Research Center for Women & Families, who has testified at several hearings on drug safety. “There’s so much emphasis on drugs being the latest, the most innovative and novel—but unfortunately this usually means it’s just new, not necessarily better,” she said.

Zuckerman conceded that it’s a given that the FDA should have the flexibility to provide access to new treatments when there are no available options. “But the FDA shouldn’t be rushing studies for diseases that have good alternatives. It’s better to have an old treatment that is proven to be safe and effective than a new treatment that we don’t know is safe and may not improve health.”

“I think we can all agree that if you have a disease for which there are no available treatment options, that is the time to be flexible, although you’d still want the best possible research,” she said.

Ross, the Yale researcher who worked on the study, encourages physicians to be more nuanced with how new treatments are presented to patients. When prescribing newly approved drugs that have limited trial data, he said physicians should be clearer with patients about what the research shows. The physician should say, “There are not a lot of options, this drug was just approved, but we don’t know if it extends your life,” rather than giving the patient the impression the drug does things for which it has not been tested.

To view the original article in Modern Healthcare, click here.