All posts by CPTFeditor

House GOP proposes changes for NIH, FDA

News Stories & Editorials
By John Fritze, The Baltimore Sun. January 27, 2015.

House Republicans are considering significant changes to the way billions of dollars in National Institutes of Health grants are awarded to research institutions under a proposal intended to speed medical breakthroughs.

The proposal, which Republican lawmakers unveiled Tuesday, would require the Bethesda-based NIH to set aside more money for high-risk research and young, emerging scientists while also giving the director more power to shape the agency’s direction.

Nearly a year in the making, the proposal from the House Energy and Commerce Committee represents a political shift from the Republican Party’s persistent effort to undercut the Affordable Care Act toward a focus on medical research that might ultimately draw bipartisan support.

The 393-page document has implications for major research institutions such as the Johns Hopkins University and the University of Maryland, Baltimore, which are among the largest recipients of NIH money in the nation.

“If we want to achieve great things at the NIH, one of the things we have to do is empower younger investigators,” said Rep. Andy Harris, a Maryland Republican and Hopkins-trained anesthesiologist whom the panel gave credit for several provisions. “I don’t think these are Democrat or Republican ideas.”

The proposal also calls for changes at the Food and Drug Administration, such as the speeding of clinical trials and extending patents for drugmakers who develop therapies for complex diseases such as Alzheimer’s. Debate over those proposals is sure to set off a flurry of lobbying by universities, drug companies and medical device manufacturers.

Yet the draft drew a tepid response from some Democrats, including one of the lawmakers who has been most closely associated with its development. Colorado Rep. Diana DeGette said in a statement Tuesday that while she appreciated the public airing of ideas, she does not endorse the proposal.

Others said they were wary of significant new requirements for the National Institutes of Health, particularly since there islittle discussion of additional funding for the agency. Research groups have complained that federal money for research has been inconsistent and has not kept pace with medical inflation.

“The problem has been Congress,” said Diana Zuckerman, president of the National Center for Health Research. “When Congress tells the NIH to do something — when it tells any federal agency to do something, there are a lot of unforeseen consequences.”

Sen. Barbara A. Mikulski, a Maryland Democrat long considered a champion of the National Institutes of Health, said she is reviewing the proposal.

“Maintaining America’s innovation edge is a subject worthy of national discussion and debate,” she said.

Dr. Francis Collins, whom President Barack Obama named as NIH director in 2009, has frequently lamented the difficulty young scientists have in securing grants. The average age of first-time recipients of the agency’s most sought-after funding is 42, even as studies suggest that scientists are likely to come up with their best ideas in their mid- to late 30s.

The House proposal includes an idea pushed by Harris to dedicate an NIH fund specifically for young researchers.

Republicans also want the leaders of individual centers and institutes, such as the National Cancer Institute, to report to the NIH director instead of the secretary of health and human services. And they would give NIH leadership more power to transfer money from one institute to another and would require the head of each institute to personally sign off on research grants.

The proposal also includes a program to dedicate an unspecified amount to high-risk research, in which unexpected breakthroughs are often developed.

An NIH spokeswoman said that officials are reviewing the draft and that the agency urges Congress “to work in a bipartisan way to more rapidly translate scientific discoveries into therapies that will improve patient outcomes.”

Neither Hopkins nor the University of Maryland responded to requests for comment Tuesday. Hopkins President Ronald Daniels used an article in a scientific journal this month to call for reforms to increase opportunities for young researchers.

Several medical research groups applauded the announcement.

“The initiative could be a game-changer for the medical innovation ecosystem,” Research!America President and CEO Mary Woolley said in a statement.

The proposal also represents something of a political victory for Harris, Maryland’s only Republican in Congress, who has been expanding his reach on medical issues in recent years. Harris, who conducted NIH-funded research on cerebral blood flow during childbirth, influenced several provisions of the bill despite not serving on the Energy and Commerce Committee.

There is little discussion in the draft about overall funding for the National Institutes of Health, which has hovered around $30 billion for the past several years. Harris, a member of the House Appropriations subcommittee that approves health agency spending, said he believes the changes could make it easier for the new Republican majorities in both chambers to consider allocating more money for NIH.

“I’m not averse to increasing NIH funding,” Harris said. “If they’re willing to listen to some of these reforms … then I think Congress is going to be willing to consider an increase in funding.”

Does abortion cause breast cancer?

Breast Cancer, Medical Treatments with Cancer Risks

No. Although there has been a great deal of controversy on this topic, scientists have agreed that abortion does not cause breast cancer.

The world’s leading experts, including epidemiologists, clinical researchers, and basic scientists, have discussed the scientific data on reproductive events in a woman’s life that could affect her risk of developing breast cancer. They evaluated the research that has been done on this topic and concluded that abortion and miscarriage do not increase a woman’s risk of breast cancer.

Breast cancer is related to reproductive experiences such as age of puberty and age of motherhood, and for years anti-abortion activists have cited research showing a link between abortion and breast cancer. That research has been quoted by some politicians as evidence that should be provided to women to discourage abortions. A workshop was held in 2003 (during the Bush Administration) at the National Cancer Institute (NCI) as a result of this controversy, and despite political pressures it concluded that the research linking breast cancer and abortion is flawed and not as credible as research indicating that there is no link between breast cancer and either abortion or miscarriage.

A medical journal article published in 20151 evaluated 15 studies on this issue, which included 31,816 women with breast cancer from seven studies in the U.S., seven studies in Europe, and one in China, conducted between 1986 and 2013. The scientists only evaluated studies which used the most reliable research design (what is known as a “prospective study”) and concluded that the evidence does not show a link between cancer and abortion.

The fact that abortion does not increase the risk of breast cancer is also supported by, among others, the World Health Organization (WHO), the National Cancer Institute and the American Cancer Society, as well as many women’s health advocacy organizations, including the National Breast Cancer Coalition, the National Women’s Health Network and Our Bodies Ourselves.

For more information on the NCI workshop and early reproductive events and breast cancer, please see: http://cancer.gov/cancerinfo/ere.

 

Congress is up to something and only you can stop them

news-you-can-use
January 23 Update

After this blog was written, Sen. Orrin Hatch (R-UT) introduced S. 160, which would repeal the tax described below. No need to look at the facts – just bow to special interests while trying to kill Obamacare! To see which 5 Democrats and 23 other Republicans who support a bill that would help destroy Obamacare, scroll below this blog. And make sure they hear from you!

Congress is Up to Something | The Huffington Post

by guest blogger Diana Zuckerman, PhD, National Center for Health Research

If you think health insurance should be affordable and you didn’t get a 65 percent raise over the last two years, keep reading!

Congress is up to something, and only you can prevent it from happening. Even though the upcoming Supreme Court decision about the Affordable Care Act could drastically curtail it, that may not be the greatest threat to the millions of Americans who don’t want to lose their health insurance.

A greater threat comes from certain U.S. companies and from hundreds of members of Congress, and the culprits might surprise you.
The senators and representatives you need to worry about include some of the most conservative Republicans, but also some Democrats that are usually strong supporters of patients and consumers–including Elizabeth Warren, Chuck Schumer, and Barbara Mikulski.

And they’re bowing to pressure from companies that advertise on NPR, your favorite TV shows, and other media, touting how they save lives every day. In truth, these companies do save lives. But they also make billions of dollars and don’t feel like giving any of it to help pay for the Affordable Care Act, as the legislation requires. And that could be fatal to countless Americans.

This is what happened: The three industries that would benefit from millions more insured Americans were asked to make small financial compromises to help pay the cost of subsidies that would make health insurance affordable to millions more Americans. The compromises included lowering certain prices, limiting profits, or paying a small excise tax on products sold.

Two of the industries kept their agreements, but the third immediately tried to repeal the part of the law that affected it.

No, it’s not Big Pharma that is the problem. Those companies understand how the Affordable Care Act helps their bottom line and their patients.

It’s not the insurance companies, either. They fought the Affordable Care Act but eventually agreed to the terms that have helped keep prices under control. They haven’t reneged, and they even lined up in greater numbers to sell policies at lower costs through the state exchanges this year.

The problem includes companies that make lifesaving heart valves and stents, hip and knee replacements, PT scanners and mammography machines, and the contact lenses that millions of us rely on.

The medical device companies selling these and other products spent more than $150 million to try to repeal a 2.3 percent tax on the devices they sell in the U.S. These include implants that cost $20 to make but that sell for $500, as well as devices that sell for half a million dollars but are as obsolete as your iPhone 2 after a few years.

They’re complaining to Congress that the tax is killing jobs and cutting funds for the research and development needed to create the innovative products that patients deserve. If they get their way and the tax is repealed, there will be $29 billion less to pay for health insurance over the next decade, and we can expect Pharma and the insurance companies to try to get out of their contributions, as well.

I’m a scientist, so I decided to examine the evidence for the “job killing” and other claims made by the device companies.

First we looked at stock prices–all publicly available online. Not all device companies have publicly traded stock, but the ones complaining the loudest about the device tax do. We looked at the 12 largest U.S.-based companies that sell nothing but devices (not ones that also sell pharmaceuticals or appliances). In the two years since the tax started, their stock went up a whopping 65 percent on average–much more than the NY Stock Exchange (25 percent) or the largest U.S.-based pharmaceutical companies (54 percent).

Then we looked at sales. Sales steadily increased over the last decade, including after the device tax was implemented. So, there would seem to be no reason to cut jobs and every reason to hire more workers.

What about R & D costs to develop new products and possibly hire new workers? Again, a steady increase over the decade, and after the tax went into effect.
What about profit margins? These were stable over the decade for most companies, despite the 2008 economic meltdown and despite the device tax. Again, no reason to cut jobs or raise a ruckus about the tax.

And yet, the House of Representatives has passed several bills that include repealing the tax, and the Senate passed a bipartisan resolution declaring its opposition to the tax. Fortunately, the resolution specified support for repeal only if another source is designated to make up for the $29 billion in revenues that the tax would provide.

Finding another $29 billion seems unlikely, yet congressional leaders keep saying there is overwhelming support to repeal the tax, and journalists repeatedly report that “widespread bipartisan opposition” to the tax will inevitably result in a repeal.

If that happens, the dominoes start to fall and the Affordable Care Act would become unaffordable.

Don’t let that happen. Here’s more information and the Senate voting record on repealing the tax. Let your voice be heard.

Diana Zuckerman is the president of the National Center for Health Research. She received her PhD from Ohio State University and was a post-doctoral fellow in epidemiology and public health at Yale Medical School. After serving on the faculty of Vassar and Yale and as a researcher at Harvard, Dr. Zuckerman spent a dozen years as a health policy expert in the U.S. Congress and a senior policy adviser in the Clinton White House. She is the author of five books, several book chapters, and dozens of articles in medical and academic journals, newspapers, and websites.

Around the same time this blog went online, 29 Senators co-sponsored a new bill to repeal the medical device excise tax: 5 Democrats and 23 Republicans. Contact the senators who haven’t co-sponsored S. 149, to urge them to reject this bill.
And if any of your senators have signed on, let them know how you feel:
S.149: Medical Device Access and Innovation Protection Act
Sponsor: Sen Hatch, Orrin G. [UT] (introduced 1/13/2015) Cosponsors (28)
Related Bills: H.R.160
Latest Major Action: 1/13/2015 Referred to Senate committee. Status: Read twice and referred to the Committee on Finance.
________________________________________
COSPONSORS(28), ALPHABETICAL:
Sen Alexander, Lamar [TN] – 1/13/2015
Sen Ayotte, Kelly [NH] – 1/13/2015
Sen Barrasso, John [WY] – 1/20/2015
Sen Blunt, Roy [MO] – 1/21/2015
Sen Burr, Richard [NC] – 1/13/2015
Sen Capito, Shelley Moore [WV] – 1/21/2015
Sen Casey, Robert P., Jr. [PA] – 1/13/2015
Sen Cassidy, Bill [LA] – 1/13/2015
Sen Coats, Daniel [IN] – 1/13/2015
Sen Collins, Susan M. [ME] – 1/20/2015
Sen Crapo, Mike [ID] – 1/20/2015
Sen Donnelly, Joe [IN] – 1/13/2015
Sen Flake, Jeff [AZ] – 1/22/2015
Sen Franken, Al [MN] – 1/13/2015
Sen Gardner, Cory [CO] – 1/20/2015
Sen Inhofe, James M. [OK] – 1/20/2015
Sen Isakson, Johnny [GA] – 1/13/2015
Sen Kirk, Mark Steven [IL] – 1/20/2015
Sen Klobuchar, Amy [MN] – 1/13/2015
Sen Lankford, James [OK] – 1/21/2015
Sen Moran, Jerry [KS] – 1/20/2015
Sen Murkowski, Lisa [AK] – 1/13/2015
Sen Portman, Rob [OH] – 1/13/2015
Sen Roberts, Pat [KS] – 1/20/2015
Sen Scott, Tim [SC] – 1/13/2015
Sen Shaheen, Jeanne [NH] – 1/13/2015
Sen Toomey, Pat [PA] – 1/13/2015
Sen Wicker, Roger F. [MS] – 1/13/2015

Mastectomy v. Lumpectomy: Who Decides?

Breast Cancer
Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund

Approximately 230,000 women in the U.S. will be diagnosed with breast cancer this year. Over the last two decades, research has regularly provided new evidence that breast cancer patients can live just as long – or even longer – with less radical treatment.

In the 1990s, research indicated that for most early-stage breast cancer (stage 0, 1, 2, or 3a), lumpectomy was just as safe as mastectomy, if the lumpectomy was followed by radiation treatment.1,2,3  At a 1990 Conference sponsored by the National Institutes of Health, experts agreed that since survival rates were the same, lumpectomy followed by radiation is the preferable treatment for most women with early-stage breast cancer.4   However, by 2013, a study indicated that lumpectomy patients live longer than mastectomy patients5 and in 2021, an enormous study that followed almost 49,000 breast cancer patients for a median of 6 years confirmed that women undergoing lumpectomy with radiation were less likely to die of breast cancer or any other cause than women undergoing mastectomy, whether or not they underwent radiation.6 The benefit of lumpectomy was maintained regardless of tumor characteristics, treatment, demographics, other health issues, and socioeconomic background.  And in 2023, a study was published indicating that for women over 65, women who choose lumpectomy lived just as long whether or not they had radiation.7

Half of the U.S. women that are eligible for lumpectomy, however, will undergo mastectomy instead. Why remove the entire breast in a mastectomy if it is safer to just remove the cancer and a “margin” of tissue around it?  Why are so many women undergoing medically unnecessary mastectomies? We’ve known since 2013 that lumpectomy is preferable because women live even longer than mastectomy patients with the same diagnosis. Could it be that many women eligible for breast-conserving surgery are getting mastectomies because they do not understand that lumpectomies are a safer option?

More Mastectomies Related to Poverty, Doctors’ Preferences, Women’s Fear

One reason is economic — surprisingly, it is less expensive to perform a mastectomy than a lumpectomy. In addition to a more time-consuming surgery, radiation adds to the cost of lumpectomy but is rarely required for mastectomy. Moreover, some insurance plans do not cover all the expenses of the lumpectomy or the radiation therapy, because they are usually outpatient procedures. According to a study of one large urban hospital in Texas serving mostly indigent women, 84% of the women with early-stage breast cancer had mastectomies and only 16% had lumpectomies.8 Similarly, a study of 20,000 breast cancer patients in North Carolina reported lower lumpectomy rates among patients who did not have private insurance.9 In some hospitals, all breast cancer patients have mastectomies, regardless of their diagnosis. Now that research shows that radiation is not necessary for many older lumpectomy patients, that should make lumpectomies more affordable, convenient, and desirable for many women.

For years, older doctors were more likely to recommend mastectomies, since that used to be the standard treatment for breast cancer at any stage. A study of 157 hospitals in North Carolina found that patients were more likely to undergo breast-conserving surgery if their surgeons were trained after 1981.10 One logical explanation is that doctors trained after 1981 were trained to do lumpectomies and are more knowledgeable about the research showing the safety of lumpectomy.  Researchers also believe that physician knowledge and attitudes are a likely explanation for the dramatic regional differences they have documented in breast-conserving surgery.

Another factor is fear. Some women are very afraid of recurrence and choose mastectomy because the chances of recurrence in the same breast are reduced when the breast is removed, even though that does not affect how long women will live. Some women are afraid of radiation therapy, which can cause fatigue or cosmetic side effects such as skin irritation or more permanent dimpling. Very infrequently radiation therapy can cause long-lasting problems. And, there is the issue of access to radiation. In rural areas, patients sometimes must travel hundreds of miles five days each week for 5-8 weeks to get radiation treatment after lumpectomy.  As noted earlier, now that research shows that many older lumpectomy patients do not need radiation, that could reduce the number of unnecessary mastectomies.

Breast cancer is still relatively rare among women in their 20’s and 30’s, but there is some evidence that women diagnosed with breast cancer at an early age tend to have more aggressive cancers. Survival rates are lower.11,12,13 This does not mean, however, that young women always need mastectomies, and each patient should receive the medical treatment that is best for her, based on her own diagnosis and preferences.

Surgical Treatment Disparities for Early-Stage Breast Cancer

These are a few examples of the studies of thousands of patients, published in major medical journals, which indicate that:

  • Mastectomies are especially likely to be unnecessary for most non-invasive breast cancers, such as ductal carcinoma in situ, yet many women with those cancers undergo mastectomies.14,15,
  • Breast-conserving surgery with radiation is somewhat more expensive than mastectomy in the short run, but breast-conserving therapy is less expensive than mastectomy after 5 years.16 Breast-conserving therapy is much less expensive than mastectomy with reconstruction.17
  • Low-income women and those who are less educated are less likely to have breast-conserving surgery. Patients without private insurance are also less likely to have breast-conserving surgery.18

References:

  1. Fisher B, Anderson S, Redmond CK, Wolmark N, Wickerham DL, Cronin WM. Reanalysis and Results After 12 Years of Follow-up in a Randomized Clinical Trial Composing Total Mastectomy With Lumpectomy With or Without Irradiation in the Treatment of Breast Cancer. N Engl J Med 1995 Nov 30;333(22):1456-61.
  2. Gangi, A et al.Breast-Conserving Therapy for Triple-Negative Breast Cancer. JAMA Surg. 2014;149(3):252-258.
  3. Agarwal, S et al.  Effect of Breast Conservation Therapy vs Mastectomy on Disease-Specific Survival for Early-Stage Breast Cancer. JAMA Surg. 2014;149(3):267-274.
  4. Abrams JS, Phillips PH, Friedman MA. Commentary: Meeting Highlights: a Reappraisal of Research Results for the Local Treatment of Early Stage Breast Cancer. J Nat’l Cancer Institute, 1995 Vol. 87. No. 24, Dec 20.
  5. Hwang ES, et al “Survival after lumpectomy and mastectomy for early stage invasive breast cancer: The effect of age and hormone receptor status” Cancer 2013 April 1; 119(7); DOI: 10.1002/cncr.27795.
  6. de Boniface J, Szulkin R, Johansson ALV. Survival After Breast Conservation vs Mastectomy Adjusted for Comorbidity and Socioeconomic Status: A Swedish National 6-Year Follow-up of 48 986 Women. JAMA Surg. Published online May 05, 2021. doi:10.1001/jamasurg.2021.1438.
  7. Kunkler, I. H., Williams, L. J., Jack, W. J. L., Cameron, D. A., & Dixon, J. M. (2023). Breast-conserving surgery with or without irradiation in early breast cancer. New England Journal of Medicine, 388(7), 585–594. https://doi.org/10.1056/nejmoa2207586
  8. Dolan JT, Granchi TS. Low Rate of Breast Conservation Surgery in Large Urban Hospital Serving the Medically Indigent. Am J Surgery 1998 Dec;176(6):520-4.
  9. Kotwall CA, Covington DI, Rutledge R, Churchill MP, Meyer AA. Patient, Hospital, and Surgeon Factors Associated with Breast Conservation Surgery. A Statewide Analysis in North Carolina. Ann Surg 1996 Oct;224(4):419-26.
  10. Kotwall, CA, Covington D, Churchill P, Brinker C, Weintritt D, Maxwell JG. Breast Conservation Surgery for Breast Cancer at a Regional Medical Center. Am J Surg 1998 Dec;176(6):510-4.
  11. Xiong Q, Valero V, Kau V, Kau SW, Taylor S, Smith TL, Buzdar AU, Hortobagyi GN, Theriault RL. Female Patients with Breast Carcinoma age 30 Years and Younger Have a Poor Prognosis: the M.D. Anderson Cancer Center Experience. Cancer 2001 Nov 15;92(10):2523-8.
  12. Carey K. Anders et al., “Breast Carcinomas Arising at a Young Age: Unique Biology or a Surrogate for Aggressive Intrinsic Subtypes?,” Journal of Clinical Oncology 29, no. 1 (2011): e18-e20.
  13. Carey K. Anders et al., “Young Age at Diagnosis Correlates With Worse Prognosis and Defines a Subset of Breast Cancers With Shared Patterns of Gene Expression,” Journal of Clinical Oncology 26, no. 10 (2008): 3324-3330.
  14. Katz SJ, Lantz PM, Zemencuk JK. Correlates of Surgical Treatment Type for Women with Noninvasive and Invasive Breast Cancer. J Womens Health Gend Based Med 2001 Sep;10(7):659-70.
  15. Gomez SL, et al. Increasing mastectomy rates for early-stage breast cancer? Population-based trends from California.  J Clin Oncol. 2010 Apr 1;28(10):e155-7.
  16. Barlow WE, Taplin SH, Yoshida CK, et al. Cost Comparison of Mastectomy versus Breast-conserving Therapy for Early-stage Breast Cancer. J Natl Cancer Inst 2001 Mar 21;93(6):447-55.
  17. Desch CE, Penberthy LT, Hillner BE, et al. A Sociodemographic and Economic Comparison of Breast Reconstruction, Mastectomy, and Conservative Surgery. Surgery 1999 Apr;125(4):441-7.
  18. Roetzheim RG, Gonzalez EC, Ferrante JM, et al. Effects of Health Insurance and Race on Breast Carcinoma Treatments and Outcomes. Cancer 2000 Dec 1;89(11):2202-13

Are Bisphenol A (BPA) plastic products safe for infants and children?

Environmental Exposures, Prevention
By Diana Zuckerman, PhD, Paul Brown, Laura Walls, and Anna E. Mazzucco, PhD

Bisphenol A (BPA) is a chemical used to make plastics. It is widely used in sports equipment, water bottles, medical devices, and as a coating in food and beverage cans. The Centers for Disease Control and Prevention found measurable amounts of BPA in the bodies of more than 90 percent of the U.S. population studied.2 The highest estimated daily intakes of BPA occur in infants and children.3

BPA is more likely to leach out of plastic when its temperature is increased, as when one warms up food in the microwave or warms up a baby bottle.2  In 2012, the Food and Drug Administration (FDA) banned the use of BPA in baby bottles—after several large manufacturers had already voluntarily removed it. Before the ban, most plastic baby bottles contained BPA.

How BPA affects our bodies

BPA mimics and interferes with the action of estrogen–a hormone that helps us develop when we’re young and eventually reproduce.4   BPA has been widely detected in blood, urine, amniotic fluid and breast milk, and has been found in nearly all adults and children who have been tested 5  For that reason, scientists are concerned about BPA’s  effects on fetuses, infants, and children at current exposure levels, and whether it can affect the prostate, brain, testicles, breasts, and behavior.2   Studies suggest that the more a baby is exposed to estrogen while in the womb, the greater the risk of breast, testicular and prostate cancer later in life.6,7,8

BPA’s effects on Animals and Human Cells

A study published in October 2008 also found that cancer cells exposed to low levels of BPA were more resistant to chemotherapy.9  Studies have also linked the hormonal effects of BPA from canned cat food to the epidemic of hyperthyroidism in cats, especially females.10 After studies of rats and mice linked BPA to hyperactivity and brain activity, the first study of nonhuman primates found that BPA levels were associated with cognitive problems that could affect learning and memory.11  BPA experiments on rats linked the chemical to precancerous lesions in the prostate and mammary glands, and to early puberty in females at BPA dosages similar to human exposures, according to a 2008 report on BPA by the National Institutes of Health’s National Toxicology Program.2 A 2014 study that  used mice to model prostate cancer in humans showed that a baby’s BPA exposure in the womb may increase risk of prostate cancer later in life 12  Another similar study in mice is creating concern about liver cancer risks as well.13  While early concerns were based primarily on animal studies and research on cells, there is increasing evidence from human studies that BPA causes serious harm. For instance, researchers have discovered possible links between BPA exposure and insulin resistance (a risk factor for Type II diabetes), increased formation and growth of fat cells (which can lead to obesity), and reproductive health problems for both men and women.4

The evidence so far is based on links scientists have observed between high levels in the body and health problems. Studies in which some people are intentionally exposed to BPA and others aren’t (randomized, controlled trials) have never been done because it could be dangerous and therefore is unethical.

Health Effects in Girls and Women

There is concern about the impact of BPA on early puberty in girls. Studies have also linked BPA to frequent miscarriages.4

In addition, several studies have found a connection between high levels of BPA and decreased fertility in women, including less success with in vitro fertilization treatments.14

Health Effects in Boys and Men

A 2009 research article reported that men who were exposed to very high levels of BPA at work had less sexual desire and were four times as likely to have problems getting and maintaining an erection than men who did not work with BPA.15 BPA-exposed workers were also seven times as likely to have problems with ejaculation. Although the men in this study had much higher levels of BPA exposure than the average man, this study demonstrates that BPA can harm men’s sexual health and that workers need to be protected. Research is needed to study the effects of more typical BPA exposures on men’s sexual health.  Unfortunately, several other studies have also linked high BPA levels to poorer sperm quality in men as well.16

Earlier Responses to BPA Concerns

The National Toxicology Program 2008 report recommended that more studies be conducted on BPA’s health effects on humans, and the report stated: “The possibility that bisphenol A may alter human development cannot be dismissed.”2

Also in 2008, based primarily on two chemical industry-funded studies, the Food and Drug Administration (FDA) claimed that BPA is safe.3 However, according to a publication of the American Chemical Society, the national professional association for chemists, 153 government-funded BPA experiments on lab animals and tissues found adverse effects while only 14 did not.1

After the 2008 National Toxicology report and FDA report, new studies of humans added greatly to concerns about the health risks of BPA.

In the fall of 2008, a major study was published in the Journal of the American Medical Association indicating that adults with higher levels of BPA in their bodies were more likely to be diagnosed with diabetes or heart disease.17 Adults with higher BPA were also more likely to be obese, but diabetes and heart disease were correlated with BPA levels even when obesity was statistically controlled.

Is it possible that BPA is contributing to the obesity epidemic and diabetes epidemic among children and adults? Wouldn’t it be ironic if the most popular water bottles for athletes contributed to obesity and diabetes?

Even before these more recent studies, the FDA Science Board, which consists of independent scientists who do not work for the FDA, disagreed with the FDA’s safety claims. The Science Board recommended in October 2008 that the FDA analyze the research literature again, relying less on the two industry-funded studies and taking into account the best independent studies. It also recommended that new research be conducted to examine BPA safety concerns. Government funding for that research was announced in late 2009.

What has actually been done to limit the potentially harmful effects of BPA?

In July 2013, the FDA responded to a petition from Representative Markey and comments from consumer groups by banning the use of BPA in packaging for infant formula, following on their 2012 ban of BPA from baby bottles.  But further action from FDA to eliminate BPA from cans and other food containers still has not happened.  Prior to the FDA ban, bills had been introduced in several states, cities, and in the U.S. Senate and House of Representatives (S. 593/H.R. 1523) to ban BPA in children’s products. Suffolk County in New York became the first in the U.S. to ban BPA in baby bottles and sippy cups, in March, 2009.   In March 2009, the six major manufacturers of baby bottles in the United States announced that they would no longer sell baby bottles made with BPA in the U.S.18 A few days later, SUNOCO, a BPA manufacturer, announced that it would require customers to confirm that no BPA would be used in food or water containers for children under 3 years of age.19  In 2008, manufacturers such as Playtex and Nalgene and retailers such as Wal-Mart pledged to remove BPA from their products and stores by the end of the year.20

Despite these efforts, BPA still remains in many canned food and beverages sold to people and pets in the U.S. and other countries.  But at least two producers of canned foods in the U.S. have BPA-free cans: Eden Foods began using BPA-free cans in 1999 and now uses BFA-free cans for everything except highly acidic tomato products, and Vital Choice introduced new cans and pouches for its fish products at the end of 2008.21,22  According to Eden, it costs the company $300,000 more a year to produce BPA-free cans, which are 14% more expensive than industry standard cans; this translates into about 2 cents more per can.23  In 2012, Campbell’s also announced that it would phase out BPA from its canned foods, although this has not yet happened.

What you can do to lower your family’s exposure to BPA

While we wait for more research to be conducted, you may want to avoid BPA. Is that possible? A 2011 study from the Silent Spring Institute showed that you can lower your BPA levels significantly by avoiding pre-packaged food and keeping your food from coming into contact with plastic containers, plastic utensils, and non-stick pans during preparation, eating and storage.24

BPA is found in polycarbonate (PC) plastics, which are typically clear and hard, marked with the recycle symbol “7″ or may contain the letters “PC” near the recycle symbol.

To avoid warming up food in plastic containers with these or other chemicals, use stoneware, china, or glass dishes and containers in your microwave. In 2012, the FDA banned BPA in baby bottles and children’s drinking cups, after several large manufacturers had already voluntarily removed it. However, bottles from before 2012 may still contain BPA.  Another problem is that manufacturers are replacing BPA in plastic bottles with other chemicals that experts believe have many of the same effects as BPA but that we know even less about. For that reason, parents may want to include safer alternatives such as glass baby bottles, particularly for use at home.

Testimony of Dr. Anna Mazzucco before the EPA Scientific Advisory Panel

Testimony & Briefings
December 3, 2014
Dr. Anna E. Mazzucco

Thank you for the opportunity to participate in this meeting.  My name is Dr. Anna Mazzucco, and I am speaking on behalf of the Cancer Prevention and Treatment Fund.  I received my Ph.D. in cell biology from Harvard Medical School, and I conducted post-doctoral research at the National Cancer Institute.  Those are the perspectives I speak from today.

Our organization conducts research and shares information with health professionals, patients, and consumers.

We applaud the efforts of the EPA to protect the public from harmful chemicals in their food, water, air and products they use every day.  We strongly support the agency’s efforts to test chemicals more efficiently, and with the best possible scientific methods.  Research has implicated endocrine-disrupting chemicals in cancer, infertility, and other health problems.  We must be able to quickly identify such agents in order to prevent them from entering our food and environment, and from affecting our health for generations to come.

Use of high-throughput technologies is critical to expediting chemical screening, and we support the agency in these efforts.  However, we have several concerns regarding the high-throughput screening approach as described in the EPA White Paper.  Specifically,

  • The EPA needs to spell out more clearly how prioritizing will be decided using this screening approach. The program should explicitly prioritize compounds based on risk contexts, such as those with widespread and persistent exposure profiles, and those with the most serious potential health effects.
  • We know that chemical exposures during sensitive periods such as prenatal and adolescent development can greatly impact health in adulthood. These critical windows should be prioritized in bio-monitoring and population-based studies.  This approach would protect the most vulnerable among us, and also ensure the greatest public health benefits for everyone.
  • Other stakeholders have expressed concern over lack of clarity regarding the relationship between the area-under-the-curve model and potency as indicated by traditional assays. We are also concerned that the model has not been tested on a sufficiently diverse set of chemical structures.  The agency needs to address these issues and provide additional evidence to support use of the current methodology, as opposed to other possible models.
  • These screening assays must be relevant to real world exposures in order to be meaningful. Broad bio-monitoring and exposure studies are vital to informing extrapolation modeling in order to reap the benefits offered by high-throughput screening.
  • As these high-throughput assays are further developed, the most orthogonal assays with the most downstream read-outs possible should be used, in order to capture the broadest possible range of mechanisms-of-actions.
  • We agree with the EPA that metabolites could be missed using in vitro studies alone, and therefore some in vivo studies will be needed.
  • We strongly urge the EPA to make the computational model fully accessible for independent assessment. That would increase transparency and stakeholder participation in this project.

 

Lastly, we share the concerns expressed in the Inspector General’s 2011 report that this process has not progressed as quickly as it should have.  We strongly urge that adequate resources be dedicated to these efforts, in order that the agency may meet its goals in a timely fashion.

Thank you for the opportunity to address the panel today.

Morcellation devices: a surgical tool that can spread cancer? What you need to know

In the News, Medical Treatments with Cancer Risks, Other Cancers
By Anna E. Mazzucco, Ph.D.
2014

If you have uterine fibroids and are considering treatment or if you’ve heard about uterine morcellation in the news, this article will help you understand the issue.

What are power morcellation devices?

A power morcellation device is a small surgical tool which cut tissue into smaller pieces.  This allows organs or other tissues to be removed through smaller incisions, making surgery shorter and leaving smaller scars behind.  The front end of a power morcellator has a spinning blade that cuts the tissue into tiny pieces (pulverizes it), and the back end is connected to a tube which sucks the tissue through the device (see image below).

morcellator

Power morcellation devices were originally designed for removal of the uterus (or the womb), but are currently used for many different types of surgical procedures because they make it easier for a physician to perform surgery using smaller incisions.

What is the controversy about morcellation devices?

In 2012, two Harvard doctors had their lives tragically affected by these devices.  Dr. Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center, which is affiliated with Harvard Medical School, had surgery in the fall of 2013 to remove her uterus due to fibroids.  After the surgery she was diagnosed with advanced (stage IV) uterine cancer, spread by the use of power morcellation during her surgery.  The morcellation left behind tiny pieces of tumor throughout her pelvic cavity, which allowed the cancer to spread.  While morcellation devices are sometimes used with a bag to contain the fibroid or tissue so that it won’t spread, the bags can be difficult to use so not all surgeons use them.   Dr. Reed was never told that morcellation would be performed during her surgery, or about the potential risks.

As a result of this surgical procedure with morcellation, a small cancer that could have been easily and completely removed through surgery has been spread and is now considered fatal.

Dr. Reed, who is now undergoing aggressive treatment for her metastasized uterine cancer, and her husband, Dr. Hooman Noorchashm, who was a surgeon at nearby Brigham and Women’s Hospital (also affiliated with Harvard), began a campaign to raise awareness of this issue and prevent other patients from being harmed.  As a result, Brigham and Women’s Hospital has since changed its policies on use of morcellation.  Since their story came out, other similar stories have surfaced, confirming that cancer has been spread by these devices, that it is not a rare event, and that it can have fatal results.  Moreover, many of these patients had not been told about these potential risks before their surgeries, and in some cases weren’t even told that morcellation would be used.  In May 2015, the Wall Street Journalreported that the FBI is investigating whether information about the risks of morcellation was not reported by hospitals, doctors, and device makers, as required by law.

What are uterine fibroids?

Uterine fibroids are non-cancerous (benign) growths on the uterus.  They are very common among women, especially during and after the reproductive years.  In many women, they do not cause any noticeable symptoms or problems.  But in some women, uterine fibroids can cause pain, discomfort during sex, and heavy bleeding.  To read more about fibroids and treatment options for them, read our in-depth article here.

What are the risks and benefits of using power morcellators?

Morcellation can allow surgeons to do shorter, less invasive surgeries.  This can reduce the chances of excessive blood loss and infection, and can reduce the amount of time spent in the hospital and result in an easier recovery afterwards.  However, in the case of fibroids, there is no way to rule out the chance of hidden cancer which could be spread by morcellation.  The Food and Drug Administration (FDA) estimates that 1 in 350 women receiving surgery for uterine fibroids has a hidden cancer that could be spread by morcellation. This is why the FDA released a warning in April 2014 recommending against morcellation for uterine fibroids.

On July 10-11, 2014, the FDA held a public meeting to discuss the risks and benefits of these devices.  Our testimony before the FDA panel on uterine morcellation, is here.

On November 24, 2014 the FDA announced that they were issuing an immediate change in the label for power morcellation devices, which will now include a black box warning as follows:

“Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”

These tragic events involving power morcellation devices raise questions about how medical devices are approved and monitored, and how a tragedy like this can be prevented in the future.  If larger studies had been done before the FDA allowed these devices to be used, and if cases of cancer being spread by morcellation had been reported to the FDA by doctors and companies, the FDA could have warned doctors and patients much earlier and prevented women from being exposed to these risks.

What do patients need to know?

If you are considering surgical treatment for uterine fibroids, be sure to discuss morcellation with your surgeon and make your wishes clearly known.  Depending on your particular situation, there are alternative surgical procedures, such as vaginal hysterectomy, which can be done without morcellation.  For any surgical procedure, make sure you have a clear and thorough discussion with your doctor about exactly how the procedure will be done, what choices you have, and what the risks and benefits of different options are.   If you feel that you are not getting enough information from your doctor, consider getting a second opinion.  Be sure to ask your doctor how often they perform the procedure you will have, because patients usually have a better outcome from surgery if the doctor performs the exact same surgery frequently.  If the physician does not have many years of frequent experience with the surgery, seek out a doctor who does.  For more tips on how to make smart decisions about medical treatments, especially use of medical devices, read our article here.

Gene Therapy May Provide Hope for Patients with Advanced Leukemia

Other Cancers
Margaret Dayhoff-Brannigan, Cancer Prevention and Treatment Fund

Acute Lymphoblastic Leukemia (ALL) is difficult to treat in children and adults. The most effective treatment is a stem cell transplant, but for patients whose cancer comes back after stem cell treatments, or who cannot be treated with a stem cell transplant, there are very few other options.

A study published in the prestigious New England Journal of Medicine in October 2014 tested a new treatment on terminally ill patients, 78% of whom survived at least 6 months.25

What is Acute Lymphoblastic Leukemia?

ALL is a cancer of the blood and bone marrow. It is the most common form of leukemia in children. In a healthy person, blood consists of red blood cells which carry oxygen and nutrients, platelets that help wounds to heal, and white blood cells which help the body fight infection. These different types of cells are made from stems cells in the bone marrow. In a patient with ALL, there are too many abnormal white blood cells that do not work properly to fight infections. These patients do not have enough red blood cells and platelets, and that can cause anemia or excessive bleeding. 26

Treatment Options

Currently there are four treatment options for ALL patients. Chemotherapy is a common cancer treatment that uses drugs to kill cancer cells. Radiation therapy is a treatment for cancer that uses x-rays or other forms of radiation to kill cancer cells. Targeted therapy uses very specific drugs or substances to identify and attack only cancer cells without causing harm to normal cells. Chemotherapy with stem cell transplant combines chemotherapy (and sometimes radiation) to kill cancer causing stem cells in the body, and then replaces them with a donors stem cells.2 How successful the treatment is usually depends on how old the person is when they are diagnosed and the amount of white blood cells the person has. ALL has a cure rate of 80-90% in childhood cases, but only about 40% in adults. Approximately 1,170 adults and 270 children die of ALL each year.27

Two Promising New Treatment for Patients with Relapsed ALL

There are two promising new treatments, but more research is needed before doctors will know more about which patients are most likely to benefit and before these treatments will be widely available.

Researchers at two hospitals in Philadelphia used an experimental treatment for ALL on 25 children and 5 adults.1 The children were seen at Children’s Hospital of Philadelphia by Dr. Shannon Maude and Dr. Stephan Grupp and their colleagues. The adult patients were treated at the University of Pennsylvania School of Medicine under the care of Dr. Noelle Frey. These patients all had relapsed several times or had failed to respond to any treatment. All had only a few weeks or months to live. The scientists took blood from each patient and separated out the white blood cells. These cancerous white blood cells were then genetically modified so that they could recognize and attack the diseased cells that cause the leukemia. The genetically modified cells were then put back in the patient using a blood transfusion.

One month after the treatment, 27 of the 30 patients were in remission. However, as the study continued, 7 of the 27 had a relapse, anywhere from 6 weeks to 8.5 months after treatment. More relapses are expected as the study continues.

Overall, 78% of the patients in the study were still alive 6 months after treatment, which was much longer than would have been expected without the gene therapy.1 When the results were written up for publication, one patient had survived two years after therapy. However, approximately half the patients had received the treatment less than 7 months earlier (some as little as 1-2 months earlier), making it impossible to calculate the average number of months of survival for the 30 patients.

Although patients were selected for the study if they were not eligible for stem cell transplant, several became eligible after gene therapy improved their health, and successfully underwent stem cell transplants or another treatment. However, the patient who has survived for two years did so without additional treatment.

We expect that a subsequent publication will give 2-year follow-up data for all 30 patients.

A different and also successful treatment for patients with relapsed or untreatable ALL was published recently by a different group of scientists at the Memorial Sloan-Kettering Cancer Center in New York City. They used a similar method to modify the genes in the patients’ white blood cells. However, this treatment was only effective at giving patients a short period of remission while they were waiting for a stem cell transplant. None of the patients in this study could be cured without also receiving a stem cell transplant.28 In contrast, the treatment studied by doctors in Philadelphia is the first to offer the possibility of a long reprieve or even possibly a cure in patients who had very little time left to live.

 

Statement of Dr. Diana Zuckerman at FDA Joint Public Advisory Committee Meeting on Chantix

Testimony & Briefings
October 16, 2014

Thank you for the opportunity to speak today.  I’m Dr. Diana Zuckerman, president of the National Center for Health Research.  I’m trained in psychiatric epidemiology at Yale Medical School, I’m a former faculty member at Vassar and Yale and a researcher at Harvard , and I’ve taught Research Methods courses, and those are the perspectives I bring with me today.  Our Center has no financial ties to Chantix or its competitors or to Chantix lawsuits.

We all know that smoking kills thousands of Americans and it is very difficult to quit.  That’s why we believe that Chantix should be available as an option for those who can use it safely.

At the same time, patients and their physicians need a clear black box warning for Chantix so they know to stop taking it when necessary

The challenge today is: which data should the FDA believe?  Mark Twain once said there are 3 kinds of lies: Lies, damn lies, and statistics.  I am a scientist and I believe in statistics, but I also know they can be easily manipulated to support a particular point of view.

Your task today is to make sense of conflicting data and decide which to believe.  They include:

  • Meta-analysis
  • Observation Studies based on hospital records
  • Adverse Reaction Reports from physicians
  • Reports from Patients

Meta Analysis is a valuable tool but its accuracy depends on the quality of each study and whether they fit together.  Meta analysis results can be useful or inaccurate depending on which studies you include and exclude.  No justification was given of why most studies on Chantix were excluded and only 5 were included in the meta analysis, including one study of schizophrenics, one study of depressed patients, and 3 studies of mentally healthy patients.  It is important to study schizophrenics and depressed patients, but those data should not be mixed together with 3 studies that exclude such patients.  No justification was given for that decision, but you heard from the FDA that most psychiatric events were in those two groups of mentally ill patients, clearly biasing the results.

To consider the studies showing no association between Chantix and psychiatric side effects, it is important to understand what happens to people with acute psychiatric events related to medication.  As the FDA speakers pointed out, most do not end up in hospitals or the ER.  Many of these psychiatric side effects are not reported in medical records.  Because psychiatric commitment laws depend on acts of violence, not threats of violence, many people with dramatic psychiatric symptoms end up in jail, not in hospitals.  In fact, some studies show that there are more mentally ill individuals in the criminal justice system than in psychiatric facilities — certainly those who suddenly behave violently toward others are likely to be put in jail, not in a hospital or ER.

There’s another, more positive reason why these psychiatric side effects might not be measured in a large study.  Fortunately, many stop quickly because patients or their doctors realize they should stop taking the drug, thanks to the black box.

For all these reasons, most of the studies that Pfizer is relying on are fatally flawed.

How can we make sense of the studies showing no impact in light of the thousands of reports of psychiatric side effects?

  • The studies cited did not evaluate all psychiatric side effects, they focused on depression and suicidal thoughts and behaviors
  • Those studies did not interview patients – a shortcoming of many large databases
  • They relied on hospital records, which research shows missed 82% of adverse psychiatric events
  • Some also relied on ER or medical records – which is better than hospital records, but will still miss a lot of data 

What about studies showing a significant increase in psychiatric events?  We all know that adverse reaction reports are the tip of the iceberg – it’s a voluntary system of reporting.  Compared to medical records, they can have a richness of information.  And while they are far from perfect, the sheer volume of thousands of reports – many more than for other drugs – is very compelling.

I’ve spoken with some patients who took Chantix, and their reactions are distinctly different from many other drug side effects, and don’t fit neatly into the categories that most of the Pfizer studies evaluated.  For example, I spoke to a man who was so besieged with uncontrollable thoughts that he locked his door at work and wouldn’t let anyone in.  His thoughts were so terrible that he just couldn’t deal with anyone.  That psychiatric reaction would be unlikely to fit into any of the studies.  Or a man who was so frightened that he hid in the corner of his bedroom under a blanket, trying to escape the uncontrollable thoughts by being as small as possible – trying to feel safe.  What study would accurate evaluate that?

If this Advisory Committee ignores the compelling psychiatric adverse reactions that have been reported, it would discredit thousands of doctors who made thousands of reports.  It would also discredit thousands of patients who reported them.  And it would send the message to the FDA to stop their Adverse Event Reporting systems, because what is the point of having such systems in place if you ignore thousand of such reports?

We need better studies, and I hope the post-market study underway will be better.  Based on previous research, we know that such studies must include very large numbers of patients, and must follow patients for a long enough time – not all reactions are within 30 days.  And, the studies must include patients’ reports of their side effects

In conclusion:

  • The studies Pfizer is citing are fatally flawed because they omit most psychiatric adverse reactions
  • Deleting the black box would send the message that thousands of doctors’ reports don’t count, including suicides and homicides

We strongly urge you to urge the FDA to keep the black box warning to protect patients and that you strengthen rather than weaken that boxed warning.  And, since the meta analyses are fatally flawed, as I and others have pointed out, the FDA should delete the misleading meta-analyses info from the Chantix label.

 

Comments on “Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting”

Testimony & Briefings
October 9, 2014

Division of Docket Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Comments of the Cancer Prevention and Treatment Fund on
“Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting”
Docket No. FDA-2014-N-0731

The Cancer Prevention and Treatment Fund appreciates the opportunity to comment on Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting.

Challenges

Due to its biological complexity and often long latency, cancer represents a challenge for monitoring in the pre-approval or postapproval setting.  Pre-market studies are usually too short-term or too small to adequately evaluate cancer as an adverse event.  Unfortunately, many postapproval studies are also too short-term, too small, or have too many patients lost to follow-up to accurately evaluate cancer as an adverse event.

Existing voluntary databases for adverse event reporting in the post-market setting are known to greatly under-report and often do not contain sufficient information.  Postapproval studies with pre-specified endpoints often have poor patient retention or are not completed.  While cancer registries can provide another source of information they often do not contain detailed drug history and are not nationwide.  Therefore, comprehensive systems for monitoring cancer as an adverse event for drugs and biologics do not exist at this time.

Long-term surveillance is critical

Cancer development is a multi-step biological process that can occur over several years, making long-term surveillance critical to identifying a cancer safety signal.  Short pre-market studies that are not specifically designed to assess cancer outcomes are unlikely to identify this potential hazard.  In addition, patient subgroups that may be particularly susceptible to cancer risks, such as children, adolescents and elderly adults taking multiple medications, are typically under-represented in pre-market studies, further decreasing the likelihood of detecting a cancer risk.

Post-market surveillance should consider all cancer types           

While concerns over specific cancer types may arise from pre-market studies, post-market surveillance should include consideration of all cancer types.  As any cancer signal can be difficult to detect pre-market, post-market surveillance needs to account for all possibilities.  As mechanisms of carcinogenesis are often shared across different tissues of origin, the possibility of cancer at multiple sites cannot be ruled out.

In 2006, the Government Accountability Office issued a report stating that the FDA needs to address weaknesses in its post-market surveillance system, including the need for larger and more diverse datasets using uniform systems such as electronic health record information.  That same year, the Institute of Medicine recommended that the FDA should take action to partner with other federal agencies and use all available resources to bolster its post-market surveillance efforts.  We strongly agree.  We recommend that the Sentinel System be used to mine specific data on the possible increased cancer risk due to the effects of non-oncological prescription medications and biological products, but Sentinel should not replace postapproval studies designed to evaluate those risks.

Concerns about cancer risks in pre-market development

If concern over a potential cancer risk arises during pre-market development, well-designed preclinical and clinical studies to directly examine this possibility need to definitively address this issue.  Specifically, sponsors need to have a clear understanding of the biological mechanism of action of their product, and perform comprehensive carcinogenicity testing.  This should include sensitized animal model systems as appropriate, and should also address non-genotoxic mechanisms of carcinogenicity, such as hormonal effects, which may display non-traditional pharmacological behavior, i.e. non-monotonic dose responses.  Any cancer concerns identified in pre-market studies should also be adequately addressed in labeling information, special warnings, and post-market studies as needed, if the product is approved.

Conclusions

To better evaluate the challenges in designing postapproval studies to determine whether a non-oncological drug causes or influences cancer, the FDA should develop long-term studies that include susceptible subgroups such as children, adolescents and the elderly.  The post-market surveillance should consider all types of cancer, and include large and diverse data sets utilizing electronic health records and the Sentinel System.  However, Sentinel should not be used as a replacement for postapproval studies.  Also, if pre-market studies flag a cancer concern, it should be addressed in the label of the drug with a special warning.

Cancer Prevention and Treatment Fund

The Cancer Prevention and Treatment Fund can be reached through Paul Brown at (202) 223-4000 or at pb@center4research.org