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Experts Say Medical Device Review System Flawed

In the News, News Stories & Editorials
The Miami Herald: July 29, 2011

The government should abandon a 35-year-old system for approving most medical devices in the U.S. because it offers little to no assurance of safety for patients, a panel of medical experts concludes in a report Friday.

The surprise recommendation from the Institute of Medicine panel calls for a massive reworking of how the government regulates medical devices, a $350 billion industry that encompasses everything from pacemakers to X-ray scanners to contact lenses.

The 12-member group’s advice, commissioned by the Food and Drug Administration, is not binding. But it could signal a new era of tighter standards for medical device manufacturers, who have long benefited from less safety scrutiny than their peers in the drug industry.

FDA requires that most new prescription drugs go through clinical trials to prove that patients fare better after receiving medication. Most devices only have to show that they are similar to devices already on the market. Truly new devices have to undergo more scrutiny.

In a highly unusual move, the FDA said Thursday evening that it disagreed with the group’s recommendations, but would hold a public meeting to discuss them.

The report arrives as the FDA fends off pointed criticism from manufacturers who say the agency has become too slow and bureaucratic in clearing new devices, driving up costs for companies and forcing some out of business. They point out that some devices reach the market two years earlier in Europe, where safety standards are lower. In the past year, companies have taken their arguments to Capitol Hill, where lawmakers have grilled FDA officials over device reviews.

But the Institute of Medicine panelists, mostly doctors and researchers, appear to overwhelmingly side with public safety advocates who have argued for years that devices used to treat and detect illnesses must undergo real medical testing.

The FDA sought the group’s advice as it updates the system used to clear more than 90 percent of devices in the U.S. The so-called 510(k) system was created by Congress in 1976 to grant speedy approval to devices that are similar to products already on the market. The pathway was originally intended as a temporary method to grandfather in devices that had been used for decades. Instead it has become the standard tool to launch new medical implants.

The IOM generally recommends ways to improve or modify government programs, but in an unexpected move the panel said 510(k) approvals are “flawed” and should be eliminated completely.

“A system was put in place 35 years ago that does not really assess safety and effectiveness,” said panel chair David Challoner, former vice president of health affairs at University of Florida. “We need something different for the next 35 years. We’re dealing with a whole new world: new technology, new materials and new data.”

Challoner and the other panelists recommend the FDA develop a new system based on safety metrics and tracking device failure rates in the real world. He said better tracking of device complications could take the place of premarket testing, which would be financially unfeasible if applied to all new devices.

The group stresses that medical devices cleared through the pathway are not inherently unsafe – most probably are safe – but the system used to clear them provides little assurance to doctors and patients.

The 510(k) system is popular among manufacturers because it is a faster, cheaper path to market than the review process for first-of-a-kind devices, which must undergo rigorous medical testing. Hip replacements, CT scanners and drug pumps are among the devices cleared by 510(k).

As generations of devices have been cleared year after year, FDA critics say dangerous devices that pose real risks to patients have slipped through because they vaguely resemble products approved decades ago.

“Originally there was this idea that the 510k would wither away and over time more and more new devices would go through the more onerous path. But instead there are more devices cleared this way than ever,” Dr. Diana Zuckerman, director of the nonprofit National Research Center for Women & Families, said in an interview Thursday.

Earlier this month Zuckerman and other safety advocates critics seized on new reports of painful complications with pelvic surgical mesh as the latest example of the shortcomings of the abbreviated review system. Reports of pain, bleeding and infection with the implants are up 500 percent since 2008 among women who’ve had surgery to support the pelvic wall. The FDA cleared the device for that use in 2002 via 510(k). Similar safety issues have plagued metal-on-metal hip implants in recent years. […]

 

Report: Medical Devices Lack Evidence of Safety and Effectiveness

Legislation, Policy
July 29, 2011

FDA Should Scrap Current Fast-Track Approval Process

The prestigious Institute of Medicine (IOM) recently released a report on the Food and Drug Administration’s 510(k) medical device clearance process, which is the short-cut used to review more than 90% of all medical devices.

Medical Devices and the Public’s Health, released in late July 2011, concludes that:

  • “The current 510(k) process is flawed” and should be scrapped. The FDA needs to develop a new system “that provides a reasonable assurance of safety and effectiveness.”
  • Information that the 510(k) clearance process promotes or hinders innovation “does not exist.”

In 2010, an FDA task force recommended numerous changes to strengthen the 510(k) process, but device companies strongly opposed the changes and enlisted the opposition of numerous Members of Congress.  As a result, the FDA delayed implementing the changes intended to protect the public health, with officials explaining that they would wait until the IOM reported on their findings.  Agency officials did not expect the IOM to come out so strongly against the current system.

The IOM report points out that the 510(k) process can’t ensure that devices are safe or effective because it bases FDA approval on a new device’s similarities to devices that are already on the market.  The IOM report determined that the system needs to require evidence of safety and effectiveness in order to protect the public health.  The report recommended that rather than spend scarce resources trying to improve the 5010(k) system, the FDA needs to create a new system that focuses on safety and effectiveness, although it can differ from the Premarket Approval (PMA) standards that are used for the highest risk devices.

“Too many patients have been injured or killed by medical devices cleared through this very flawed short-cut known as the 510(k) process,” said Dr. Diana Zuckerman, president of the National Research Center for Women & Families and the Cancer Prevention and Treatment Fund.  “Patients have been harmed by millions of devices, including defective hips, heart devices, diagnostic tests, and implanted mesh products that haven’t been tested on people. All devices that are implanted and life-sustaining should be held to a much higher standard.”  Dr. Zuckerman has advocated for stronger medical device safety regulations for years, testifying about this in the House of Representatives in 2006 and at a Senate hearing in 2011.

The IOM report is a major setback to the powerful medical device industry, which has spent a king’s ransom lobbying Senators and Congressmen to weaken medical device clearance regulations under the guise of promoting device innovation.

The report echoes the National Research Center for Women & Families’ concerns about the lack of evidence that these devices actually work and are safe. We found that millions of unsafe medical devices are recalled every year that were originally cleared through the 510(k) process.  See our study in the prestigious peer-reviewed journal, Archives of Internal Medicine,”Medical Device Recalls and the FDA Approval Process.”

NRC for Women & Families urges the FDA to immediately strengthen the device approval process by incorporating safety and efficacy standards into the current 510(k) review.  And it calls on the Congress to prioritize public health safety over industry demands to support the status quo.

Procrit, Aranesp, and Epogen-all risk and no benefit of Erythopoiesis-Stimulating Agents (ESAs) for patients with anemia due to chemotherapy?

Medical Treatments with Cancer Risks
Caroline Novas, Cancer Prevention and Treatment Fund

Anemia drugs are widely used by patients undergoing chemotherapy and patients with chronic kidney disease, but there is growing evidence that the misuse of these drugs is harming many patients. The FDA issued a “safety communication” on June 24, 2011 recommending lower doses of anemia drugs for patients with chronic kidney disease. This warning was based on studies showing increased risk of stroke, blood clots, other cardiac problems, and death for patients with chronic kidney disease.1

Procrit, Aransep, and Epogen are Erythopoiesis-Stimulating Agents (ESAs), which refers to synthetic versions of a protein that increases the production of red blood cells. By increasing red blood cells, these drugs reduce the need for blood transfusions.

The latest FDA “communication” again raises concerns about the safety of these drugs for any use, including patients with anemia due to chemotherapy. Studies show that cancer patients who receive ESAs have worse outcomes than patients who do not, because of higher mortality rates as well as faster cancer progression. In addition, evidence presented at a 2008 FDA meeting showed that only one in three cancer patients benefit from taking ESAs.2 The FDA requires this information on the labels for these drugs, but they continue to be widely used.

Procrit, Aranesp, and Epogen are multibillion dollar sellers manufactured by Amgen Inc.3 These drugs were approved by the FDA to treat anemia caused by chronic kidney condition in 1989 and chemotherapy in 1993.4

What is the connection between chemotherapy and anemia? Chemotherapy eliminates cancer cells but also attack healthy red blood cells. When a person’s red blood cell count falls very low, anemia is the result.3 In fact, seven out of ten chemotherapy patients develop anemia.5

In 2007, the FDA required warning labels for ESAs to treat patients with cancer and chronic kidney disease. The labels emphasize the risk of tumor growth and shortened survival when prescribed at a high dosage. Additionally, the warning label states that “symptoms of anemia, fatigue, and quality of life have not been shown to improve in patients with cancer who are treated by ESAs.”6

In 2010, the FDA finally responded to the studies showing increased tumor growth and shortened survival time.  Although the FDA did not take the drugs off the market, they did issue a drug safety recommendation to recommend a risk management strategy program to improve safety for patients who have anemia due to chronic kidney disease and chemotherapy. Oncologists treating cancer patients must now undergo training before prescribing the drug. It also required that patients sign a written acknowledgment stating that the doctor has explained the risk of taking the drug.2

Given the FDA statement that ESA drugs do “not improve fatigue, patient well-being, or quality of life” and that the drugs only benefit one in three cancer patients,2 why does the agency allow cancer patients to continue taking the drug? They do so because there is no doubt that ESAs can reduce the need for blood transfusions. In addition, some patients respond very well to the drugs, and do not experience the side effects of increased tumor growth.7 As a result, for many patients the benefits of reduced blood transfusions outweigh the risks of tumor growth and increased mortality rates.  The problem is that it often isn’t possible to determine which patients are likely to benefit and which are more at risk. In other words, for many patients, ESAs are a gamble.

If you are taking any of these drugs because of either chronic kidney disease or chemotherapy, talk to your doctor to see if the benefits of staying on the drug are likely to outweigh the risks.  Make sure your doctor is aware of the FDA’s latest concerns and the research evidence of serious risks.  You might consider asking your doctor about going off the drug to see if you are better off without it.

References:

1The Food and Drug Administration. FDA News Release: FDA modifies dosing recommendations for Erythropoiesis-Stimulating Agents. (June 2011) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm260670.htm

2Lowes, Robert. FDA to Require Oncologist Training for ESA Use in Cancer Patients. MedScape News Today.  February 16, 2010.

3FDA recommends lower doses of anemia drugs. USA Today. June 6, 2011. http://yourlife.usatoday.com/health/medical/story/2011/06/FDA-recommends-lower-doses-of-anemia-drugs/48815974/1

4Centers for Disease Control and Prevention. National Chronic Kidney Disease Fact Sheet: General Information and National Estimates on Chronic Kidney Disease in the United States, 2010. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2010.

5Patient Advocate Foundation. Chemotherapy-Related Anemia Guide. http://www.patientadvocate.org/help.php?p=194

6The Food and Drug Administration. News Release: FDA Strengthens Boxed Warnings, Approves Other Safety Labeling Changes for Erythropoiesis-Stimulating Agents (ESAs). November 8, 2007. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109024.htm

7The Food and Drug Administration. Questions and Answers for Erythropoiesis-stimulating Agents (ESAs) Labeling Changes. November 8, 2007. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110280.htm

Lowering the Cost of Cancer Treatment

Cervical Cancer & HPV, Cost, General Treatment Issues
Krista Brooks, Cancer Prevention and Treatment Fund

The number of new cases of the four most common types of cancers (prostate, breast, lung, and colorectal) have been declining since 1998, but Americans are still spending billions in cancer care costs.[1] In 2006, cancer care accounted for an estimated $104.1 billion in medical care spending in the United States and that number will continue to increase in the upcoming years.[1] The National Cancer Institute found that if incidence (which means the number of new cases), survival, and treatment costs stay the same, cancer costs in 2020 will show a 27% increase from 2010 solely based on the growing and aging population in the U.S.[2] As cancer treatment becomes more effective, the increasing number of cancer survivors will require additional care, which will also contribute to overall cost increases.[2] While these trends reflect a changing U.S. population and the increase in cancer survivors, they do not explain why each individual must pay so much for cancer care and treatment.

A survey conducted by the Kaiser Family Foundation found that one in four families affected by cancer say the experience used up all or most of the patient’s  savings, and one in eight say they borrowed money from relatives.[3] For the uninsured, the burden was even higher: “one in four delayed or decided not to get treatment because of its cost.”[3] These treatments are often essential, but the high costs are often not sustainable for individuals, families, or for the U.S. healthcare system.

Why do Cancer Treatment Costs Continue to Rise at Astronomical Rates?

Pharmaceutical companies, physician practices, and cancer screenings all play a role in the rising costs of treating cancer patients.  The treatment costs could be reduced, however.  Fortunately, there are now a variety of treatment options from which most patients can choose.  One problem is that pharmaceutical companies tend to charge higher prices for their new drugs; for example, Provenge, used to fight prostate cancer, is $93,000 for just one course of treatment.[4] Avastin typically costs stage 4 breast cancer patients more than $80,000, but the latest research indicates that for most patients it does not increase survival and is likely to harm quality of life.[5,6] Some cancer medications range from $5,000 to $10,000 per month, which over several years really adds up.[7] Many of these new drugs work for relatively few people, while most patients pay thousands of dollars and do not benefit or may even be harmed.  The companies have no incentive to determine which patients are most likely to benefit, if they can instead sell the drugs to most patients, including those who won’t benefit.  That leaves doctors and patients trying many expensive treatments until they find one that works for each individual.  Insurance companies, Medicare, and sometimes the individual must pay these exorbitant costs during this trial and error treatment.

Another factor that contributes to the high cost of cancer treatments can be a physician’s own treatment recommendations.  Physicians are there to help their patients, but research has shown that physicians who have financial ties to specific companies tend to recommend medical products made by those companies.[8,9] Many patients also rely on Medicare, which is not allowed to deny or limit cancer treatment based on cost.  As a result, Medicare patients and their doctors often have no incentive to choose equally effective but less expensive medications and treatments.[10,11] Doctors and patients also have little incentive to question high-priced treatments.[12] Unfortunately, physicians frequently do not adhere to evidence-based guidelines, leading them to sometimes prescribe and perform tests that may be more expensive than beneficial to patients.[13]

Cancer costs can add up-even before cancer is actually diagnosed.  Cancer screenings are designed to increase the number of patients who are diagnosed early, before they have any symptoms. When performed according to recommended guidelines, screening can help patients get a much earlier start on treatment. However, cancer screening tests often identify abnormalities that may or may not be cancer, which can result in expensive testing, unnecessary treatment, and added costs.  These costs can’t always be avoided, but they are increased when screening guidelines are not followed.  For example, a 2011 study found that a large number of elderly men were being screened for prostate cancer even though they were beyond the target age range for testing.[14] Prostate cancer screening tests can cause serious harm, exposing men to unnecessary treatments as well as unnecessary costs.  Similar results have been found for cervical cancer screening in women.  Certain types of HPV (Human Papillomavirus) have been linked to cervical cancer, so physicians like to determine the type of HPV as a method to screen for cervical cancer.  Unfortunately, a Center for Disease Control (CDC) study found that physicians are performing unnecessary and expensive routine HPV tests.[15] When HPV tests were initially developed, two types of tests were run together: one to detect HPVs that can cause cancer, and one for HPVs that don’t cause cancer.  However, now that an HPV test that focuses only on cancer-causing HPV has been available, that is the only HPV test recommended for physicians to use.  This recommended test should only be done for women over 21 who have inconclusive pap smear results, or women over 30 who are undergoing pap smears. The problem is that many physicians and clinics are using the cervical cancer HPV test routinely for all patients, or are using both the recommended HPV test and the non-recommended test for non-cancerous HPV; either of these inappropriate uses results in a doubling of medical bills, without any additional benefit to the patient.[16] Screening mammograms for women above or below the recommended age range, or given more frequently than recommended, also result in unnecessary anxiety, treatment, and medical expenses, which outweigh the benefits for most women.[17]

Is There Any Way to Reduce These Costs?

The skyrocketing cost of cancer treatments has brought the issue to public attention, as politicians, doctors, and organizations speak out about ways that we can work together to reduce these costs   Dr. Howard Brody’s “Call to Action” in the New England Journal of Medicine challenged physicians to name five high-priced treatments that are commonly used in practice, but have not been shown to be highly effective in patients.  He pointed out that if physicians can exchange these practices for low-cost, more effective treatments, a small dent could be made in rising healthcare costs.[18] Two oncologists responded to Brody’s request with five ways to reduce costs for cancer treatments.  They include using imaging and tests only where benefits to patients have been shown, limiting chemotherapy for people that are very weak and would not benefit from this additional treatment, and a greater coordination of care.  Additionally, they suggest an increased focus on palliative care, which has been found to make patients more comfortable, have better health outcomes, and reduce the number of costly and often ineffective treatments tried during the patient’s final months.[19,20]

To combat the rising costs of medications and medical devices, the 2010 health care reform law encourages more comparative effectiveness research through the formation of a non-profit Patient Centered Outcomes Research Institute.[21] This institute will help ensure that new medical treatments are studied to determine if they are better or worse than ones already on the market.  Similarly, two researchers are proposing a new type of regulation called “reference pricing” to ensure that patients are getting more out of these new treatments.  Reference pricing would require that medical products paid for by Medicare be tested to compare them to similar products that are already on the market. The companies would have 3 years to prove that their new product is better than the ones already on the market. If tests do not show that the product is safer or more effective, it could not be sold at a higher price than the older products on the market.  While reference pricing is not required as part of the health care reform law, it could be used as a strategy under the law to encourage medical product manufacturers to finance comparative effectiveness research.[22]

Changing physician and pharmaceutical company practices might seem like a daunting task, but there are some small steps that you as an individual can do to help lower costs associated with cancer treatments.  It is important that you discuss your financial and medical situation with your doctor. Make sure that you fully understand your illness and make sure your doctor fully understands your financial situation.  In some cases, your doctor may be able to prescribe less expensive, but just as effective, drug treatments that could save you money.[23] Additionally, it is important to talk to your doctor about regular cancer screenings and your family’s history of certain cancers or diseases.  You might be in the target age-range or at risk for other reasons that meet the standards of some screenings, but not for others.  This will help to maximize the benefits you will receive from these health screenings and help to eliminate unnecessary costs or treatments.[24]

Patients deserve a high standard of quality of care. Fortunately, it is possible to lower costs while maintaining or even improving the quality of care. We can do this with unbiased research to determine which treatments are most effective and by creating regulatory methods to ensure that the cost of medications must reflect their effectiveness.

If you or a loved one has been diagnosed with cancer and would like to learn about financial assistance options, please visit The National Cancer Institute (NCI) web site https://www.cancer.gov/about-cancer/managing-care/track-care-costs.  They offer a wide variety of resources to help with cancer treatment costs for those with and without health insurance.

References:

  1. National Cancer Institute, NIH, DHHS (2010) Cancer Trends Progress Report – 2009/2010 Update, Bethesda, MD, http://progressreport.cancer.gov.
  2. Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, and Brown ML. (2011). Projections of the Cost of Cancer Care in the United States: 2010-2020., Journal of the National Cancer Institute 103(2). Retrieved from http://jnci.oxfordjournals.org/content/103/2/NP.2.full
  3. USA Today/Kaiser Family Foundation/Harvard School of Public Health National Survey of Households Affected by Cancer. November 20, 2009.http://www.kff.org/kaiserpolls/pomr112006pkg.cfm. Accessed February 10, 2010
  4.  No Author, (2011) The costly war on cancer. The Economist. Retrieved from http://www.economist.com/node/18743951
  5. Twombly, R. (2011). Avastin’s uncertain future in breast cancer treatment . Journal of the National Cancer Institute, 103(6), Retrieved from http://jnci.oxfordjournals.org/content/103/6/458.full
  6. Ranpura, V, Hapani, S, and Wu, S. (2011). Treatment-related mortality with bevacizumab in cancer patients. The Journal of the American Medical Association, 305(5), Retrieved from http://jama.ama-assn.org/content/305/5/487.full
  7. Goozner, M. (2011) Health care reform: Prove it works and CMS will pay. The Fiscal Times. Retrieved from http://www.thefiscaltimes.com/Articles/2010/10/05/Health-Care-Reform-CMS-Wants-Proof-to-Pay.aspx
  8. Elkin EB and Bach PB (2010). Cancer’s next frontier: Addressing high and increasing costs. The Journal of the American Medical Association, 303(24). Retrieved from http://jama.ama-assn.org/content/303/11/1086.short?home
  9. Jost, TS. (2010). Oversight of marketing relationships between physicians and the drug and device industry: a comparative study. American Journal of Law and Medicine, 36. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/20726399
  10. Weight, CJ, Klien, EA, and Jones, JS. (2008). Androgen deprivation falls as orchiectomy rates rise after changes in reimbursement in the U.S. Medicare population. Cancer, 112(10), Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/18393326
  11. Goozner, M. (2011) Health care reform: Prove it works and CMS will pay. The Fiscal Times. Retrieved from http://www.thefiscaltimes.com/Articles/2010/10/05/Health-Care-Reform-CMS-Wants-Proof-to-Pay.aspx
  12. No Author, (2011) The costly war on cancer. The Economist. Retrieved from http://www.economist.com/node/18743951
  13. Brody, H. (2009). Medicine’s ethical responsibility for health care reform – the top five list. New England Journal of Medicine. Retrieved from http://healthpolicyandreform.nejm.org/?p=2616
  14. American Society of Clinical Oncology (2011). Many elderly men are undergoing unnecessary PSA screenings, researchers find. ScienceDaily. Retrieved June 20, 2011, from http://www.sciencedaily.com­/releases/2011/03/110328161848.htm
  15. Lee, JW, Berkowitz, Z, and Saraiya, M. (2011). Low-risk human papillomavirus testing and other nonrecommended human papillomavirus testing practices among U.S. health care providers. Obstetrics & Gynecology, 118(1), doi: 10.1097/AOG.0b013e3182210034
  16. Lee, JW, Berkowitz, Z, and Saraiya, M. (2011). Low-risk human papillomavirus testing and other nonrecommended human papillomavirus testing practices among U.S. health care providers. Obstetrics & Gynecology, 118(1), doi: 10.1097/AOG.0b013e3182210034
  17. Quanstrum, KH and Hayward, RA. (2010). Lessons from the mammography wars. New England Journal of Medicine, 363. Retrieved from http://www.nejm.org/doi/full/10.1056/NEJMsb1002538
  18. Brody, H. (2009). Medicine’s ethical responsibility for health care reform – the top five list. New England Journal of Medicine. Retrieved from http://healthpolicyandreform.nejm.org/?p=2616
  19. Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, and Brown ML. (2011). Projections of the Cost of Cancer Care in the United States: 2010-2020., Journal of the National Cancer Institute 103(2). Retrieved from http://jnci.oxfordjournals.org/content/103/2/NP.2.full
  20. Smith TJ and Hillner BE. (2011). Bending the cost curve in cancer care. New England Journal of Medicine. Retrieved from http://healthpolicyandreform.nejm.org/?p=14541&query=home
  21. Kaiser Family Foundation. (2011, April 19). Summary of new health reform law. Retrieved from http://www.kff.org/healthreform/8061.cfm
  22. Goozner, M. (2011) Health care reform: Prove it works and CMS will pay. The Fiscal Times. Retrieved from http://www.thefiscaltimes.com/Articles/2010/10/05/Health-Care-Reform-CMS-Wants-Proof-to-Pay.aspx
  23. Consumers Union of U.S. (2009, March). 10 ways to reduce your drug costs. Retrieved from http://www.consumerreports.org/health/prescription-drugs/10-ways-to-reduce-your-drug-costs/overview/10-ways-to-reduce-your-drug-costs.htm
  24. Quanstrum, KH, and Hayward, RA. (2010). Lessons from the mammography wars. New England Journal of Medicine, 363. Retrieved from http://www.nejm.org/doi/full/10.1056/NEJMsb1002538

Breast Thermography Cannot Replace Mammograms

Breast Cancer, Prevention
Dana Casciotti, PhD, Cancer Prevention and Treatment Fund

In June 2011 the Food and Drug Administration (FDA) issued a warning to women who undergo breast cancer screening:  Do not replace mammograms with thermograms.

Thermograms are pictures of the breast made with a special type of camera (an infrared camera) that shows patterns of heat and blood flow near the surface of the breast.  Supporters of thermography say that these pictures can help doctors see new blood vessel growth, the very earliest sign that a tumor could develop.  Supporters also claim the pictures help identify very early tumors that are not big enough to find with other screening tests.  Thermograms are less painful than mammograms because they do not require squeezing the breast, and they also don’t expose the breast to radiation.  This sounds great, but does it really work?

Early detection of breast cancer is very important because it can save lives and reduce the need for mastectomy (surgery to remove the breast) or chemotherapy.  However, the FDA said there is currently not any “valid scientific data to show that thermographic devices, when used on their own, are an effective screening tool for any medical condition including the early detection of breast cancer or other breast disease.”[1]

Some research shows that thermography might be useful in combination with mammography, especially for women with dense breasts.[2,3] With mammography, dense breast tissue looks white and so does a cancerous tumor, so it is often hard to detect cancer.  Younger women tend to have denser breasts, so mammography in combination with thermography might be more accurate, especially for young women at high risk of breast cancer because of close relatives with breast cancer. Breast cancer screening is not recommended for young women with an average risk of breast cancer.[1]

More research on thermography should be done to determine whether it is truly useful for early detection.  As mentioned above, thermography can identify the earliest signs of tumor growth.  However, these early signs do not necessarily mean breast cancer will develop and they are generally too early to require treatment. Even though it is an easy procedure that simply takes a picture of the breast, its risks might outweigh the benefits if it results in unnecessary follow-up and treatment. That’s why more research is needed to determine if thermography can replace mammography for breast cancer screening.

The FDA is worried that ads for thermography facilities, web sites, and mobile units are misleading women. For example, here is an ad that calls breast thermography “the safe alternative to mammography.” That is not true. Thermography may be a safer test since it does not expose women to radiation, but there is not enough evidence that it is effective and can be used alone for breast cancer screening.

References:

  1. U.S. Food and Drug Administration. Thermographic Imaging Systems for Breast Cancer Screening: FDA Safety Communication. June 2, 2011.  Accessed on 6/8/11 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257707.htm.
  2. Arora N, Martins D, Ruggerio D, et al. (2008).  Effectiveness of a noninvasive digital infrared thermal imaging system in the detection of breast cancer. Am J Surg. Oct;196(4):523-6.
  3. Kennedy DA, Lee T, Seely D (2009). A comparative review of thermography as a breast cancer screening technique. Integr Cancer Ther. Mar;8(1):9-16.

Testimony of Diana Zuckerman, PhD, President of the Cancer Prevention and Treatment Fund, Before the FDA, June 28, 2011

Testimony & Briefings

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

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

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

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

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

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

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

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

Most Women with Silicone Breast Implants Need More Surgery

News Stories & Editorials
Rita Rubin, MSNBC: June 22, 2011

More than one in five women who had silicone breast implants for cosmetic purposes and half of those who got the implants after a mastectomy needed surgery to remove the implants within a decade, according to a Food and Drug Administration report out Wednesday.

“Recognize that breast implants are not lifetime devices,” says the FDA report on the longest studies on the implant to date. “The longer you have your implants, the more likely it will be for you to have them removed.”

In 2010, U.S. surgeons performed nearly 400,000 breast implant procedures. About three-quarters were for breast augmentation, while the rest were for breast reconstruction. About half the surgeries used silicone gel implants; the other half used implants filled with saline.

Silicone implants were pulled off the market in 1992, after concerns were raised about lack of safety data and worries that leaking silicone was linked to immune-system disease.

But the FDA returned the implants to the market in November 2006 after clinical trials didn’t find a link to feared diseases. Plastic surgeons and some women were clamoring for the return of the silicone versions because they say they look and feel more real than saline, which can ripple because it’s essentially a sack of salt water.

The approval required implant makers Allergan and Mentor to conduct large 10-year studies following up on patient experiences, and Wednesday’s report is the first glimpse at how the breast implants held up.

The FDA says 20 to 40 percent of patients who get silicone implants for cosmetic reasons will need another operation to modify or remove them within 10 years. For women with implants for breast reconstruction, the number is even higher, at 40 to 70 percent. The biggest issue was scar tissue hardening around the implant.

Other complications include implant rupture, wrinkling, asymmetry, pain and infection, the report said. Women with breast implants are also slightly more likely to be diagnosed with anaplastic large cell lymphoma, a rare form of cancer.

Despite the risk of complications, the FDA believes that silicone implants are reasonably safe, the report said.

But women in the studies had a high dropout rate and so other complications or long-term safety issues might be missed, the agency’s report says.

Mentor has three-year data for only one out of every five women in its study, while Allergan has two-year data for three out of every five, according to the FDA’s safety update.

“Low follow-up rates and other study limitations may limit interpretation of the data and preclude the detection of very rare complications,” the agency concluded.

Without knowing why patients have dropped out of the studies, it’s impossible to reach any conclusions about implant safety, says Diana Zuckerman, president of the nonprofit National Research Center for Women & Families in Washington, D.C.

“Did they stop going to the doctor because their implants were removed?” Zuckerman says. “Did they stop going because they died or got very sick? Or are they so happy with their implants that they skipped follow-up visits?”

The FDA has been working with the companies to improve patients’ participation in the studies and will convene a meeting of outside experts to discuss the issue later this summer, says William Maisel, deputy director for science and chief scientist at the agency’s Center for Devices and Radiological Health.

Most women who get breast implants are in their 20s and 30s, and may mistakenly consider breast implants a one-time investment.

“They need to understand they’re going to need many removals and replacements for the rest of their lives,” Zuckerman says.

Women as Guinea Pigs: Tungsten in Breast Cancer Patients

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

A medical device that was never tested in human studies has been recalled because it left hundreds of tungsten particles in the breasts of women being treated for breast cancer. See Riddled With Metal by Mistake in The New York Times.

The Axxent FlexiShield Mini, made of silicone and tungsten, was intended to protect healthy breast tissue from radiation during a new radiation technique for women undergoing lumpectomies to treat breast cancer.

Rather than requiring clinical trials and inspections, as is done for prescription drugs and less than 5% of medical devices, the FDA allowed the shield to be sold after reviewing it through the less stringent 510(k) process.  FDA spokesperson Karen Riley referred to this decision as appropriate in order to avoid “reinventing the wheel” for devices that are similar to those already on the market.  The shield was deemed by the FDA as “substantially equivalent” to an older shield made with lead; the new shield is made with tungsten and silicone, and left hundreds of tiny tungsten particles in the women’s breasts.

No one knows the health risks of tungsten in breasts, but at the very least, the particles interfere with the accuracy of mammograms because they show up on mammograms as white specks, which look just like small specks of cancer.  If the doctor assumes the specks are tungsten, not cancer, the women could have undiagnosed and untreated cancer, which could be deadly.  If the doctor assumes the specks are cancer, but they are actually tungsten, the women will have surgery that is not necessary.

This is a great example of why potentially dangerous medical devices should be subject to clinical trials and inspections (Medical Device Recalls and the FDA Approval Process).  Without those safeguards, it can take years to discover that a device is defective; meanwhile, thousands of patients can be harmed.  The tungsten problem was noticed quickly only because the patients were participating in a clinical trial of a new radiation technique-there were no clinical trials of the tungsten device.   Because the women were in a study of the radiation technique, the doctors did a 6-month follow-up with mammograms for all their patients, and that’s when they discovered the tungsten particles in the women’s breasts.

What if the women hadn’t been in that study?  The tungsten shield was cleared by the FDA in June 2009, and when we checked on March 21, 2011, there was only one report of the tungsten particles on the public reporting system for medical device defects.  That report referred to four different patients with tungsten particles in their breasts, and was made by an unnamed nurse in June 2010 but not “received” by the FDA until January 2011. We don’t know what the delay was in reporting, but we know that more than four patients have already been diagnosed as having tungsten particles in their breasts due to the shield.  If the patients hadn’t been participating in a clinical trial of the new radiation technique, it could easily have taken many additional years before health professionals reported the problem for so many patients that the FDA noticed the reports.  FDA receives too many reports of medical device serious adverse reactions to study all of them so it can take a long time to come to their attention.

The breast cancer patients who had been exposed to the tungsten shield had undergone lumpectomies.  The surgeon therefore had removed the cancer but not the women’s breasts.  Now, a year later, those same women must consider mastectomies to rid their bodies of tungsten, not cancer–a problem that would not have happened if the device had been carefully tested in either animals or humans, and the manufacturing plant had been inspected, before the device was sold.

This is an example of what happens when FDA allows medical devices to be sold without solid scientific evidence.  When a medical device could cause this kind of damage, it should be carefully tested first to make sure it is safe before thousands of patients use it.  Before studying it on even one woman, the shield could have been tested on animals or perhaps in excised tissue.  Instead, patients paid for this dangerous device without it ever being tested-even on them.

Eating Habits that Improve Health and Lower Body Mass Index

Diet, Habits, & Other Behaviors
Susan Dudley, PhD and Sarah Pedersen, Cancer Prevention and Treatment Fund

More and more research studies are confirming the importance of keeping body mass index (BMI) and waistline measurements under control in order to reduce the risk of cancer, other serious diseases, and premature death. But sticking to a healthy diet – especially when we’re trying to lose weight – can be hard for lots of reasons. Keeping track of calories and fat percentages can be confusing, and the nutrition labels on the foods we buy aren’t always that helpful. How are consumers supposed to figure out which diet advice is just hype – that ultimately don’t contribute to better health – and which advice offers good, medically sound information?

Here are some basic guidelines to keep in mind:

  • Calories matter
  • Serving size matters
  • Fats and cholesterol matter
  • Fruits, vegetables and whole grains matter
  • Exercise matters
  • Sticking to it matters

The Only Way to Lose Weight is to Eat Fewer Calories Than You Burn in a Day

Simply increasing your activity level might be enough if you only need to lose a few pounds to get your BMI into a healthy range.  Most of the time, however, eating fewer calories is also going to be needed.  The calories and fat in the foods we eat add up quickly!  For example, have you eaten at a fast food chain recently?  To work off the calories from a double cheeseburger, extra large fries and a 24 ounce soft drink – about 1500 calories – you would have to run for two and half hours at a ten minute mile pace! (For more information, see Fast Food Facts: Calories and Fats).

Eating Fewer Calories Doesn’t Necessarily Mean Eating Less Food

The trick to dieting without being hungry is to choose foods that contain fewer calories and also fill you up. An example of this would be having a piece of fruit instead of fries with lunch.  It helps to remember that not all foods are created equal!  Some foods, such as nuts, are high in nutrients and essential vitamins, while others lack nutritional substance, such as products containing added sugars. “Nutrient-dense food” provides substantial amounts of vitamins and minerals and relatively few calories, but leaves you feeling fuller while also supplying valuable fuel for your body.  A person is more likely to stick to a diet-while feeling better and healthier-if calories are nutrition-dense.  Empty calories from simple carbohydrates found in foods with processed and refined sugars, such as candy, pasta and bread made from white flour, and foods with corn syrup, leave you hungry again soon after, craving more food.  This is because simple carbohydrates quickly turn into useless sugar, whereas complex carbohydrates, such as vegetables, whole-grain breads and cereals, and low-fat yogurt and milk, provide long-lasting nutrients, improve digestion, help stabilize blood sugar, and keep your energy at an even level.  Although foods such as fruit are also considered simple carbohydrates, they contain vitamins and nutrients that occur naturally, unlike those found in processed and refined foods.

A 2011 study in the respected New England Journal of Medicine found that certain foods were linked to weight change more than others. After following participants for an average of 17 years, researchers found that weight increase was most strongly linked to foods such as potato chips, sugar-sweetened beverages, and unprocessed red meats.  Foods such as vegetables, whole grains, nuts, fruits, and yogurts were closely linked to preventing weight-gain.

Eating 5 Smaller Meals Might Work Better Than Eating 3 Larger Ones

Most people are surprised to learn that eating 5 or 6 times a day can be a better way to lose weight than eating only 3 times a day! This only works, however, if you take care to control not only the calorie content but also the amount of food you’re eating.  The goal is to eat a small amount of food – like a cup of no-fat yoghurt, for example – every 3 hours or so.  Eat only enough so that you don’t feel hungry, but never so much that you feel stuffed. Some people recommend eating your meals off of smaller plates, because research has shown that people have a tendency to try to eat all of what is served to them. Unfortunately, portion sizes for restaurant meals and other prepared foods, and even in our homes – everything from breakfast muffins to a plate of spaghetti – have grown to very unhealthy proportions in the last two decades.

Eat Less Cholesterol and Less Fat – Especially Less Saturated Fat, and Almost No Trans-Fat

Most people have heard that cholesterol is bad, and eating less of it is important.  But our bodies also make cholesterol from the fats that we eat. Fats are also very high in calories. So cutting down on total fat intake is helpful.

All fats, however, are not alike, and that’s why it’s important to check food labels to be sure that you’re eating the smallest amount of saturated fat and of trans fat possible. These tend to be the kinds of fat that are found in milk and milk products, those that are solid at room temperature – like the fat in meat products, butter, margarine, shortening and lard – and the fats that come from baked goods and fried foods. The fats you do eat should be mostly “unsaturated” or “polyunsaturated” fats. Although there are some exceptions, these tend to be liquid at room temperature, like canola oil, olive oil and some of the other vegetable oils.

Eat More Fruits, Vegetables, Whole Grains, and Low- or No-Fat Dairy Products Every Day

There are many good resources to help you learn about healthy eating. For example, the US Department of Agriculture website at My Plate helps you tailor the government’s dietary recommendations to your nutritional needs. Nutritionists at the Harvard School of Public Health have similar (but not identical) healthy food guidelines. What these diets have in common includes recommendations to:

  • Aim for at least five servings of fruits and vegetables a day. Usually, the more colorful the fruit or vegetable, the more nutritious. For example, dark green spinach has more nutrients than light green iceberg lettuce.
  • Try and choose whole grain cereal, pasta, rice, and bread. Many foods that claim “whole wheat” or “whole grain” on the front of the package are really made with mostly white, processed flour – which isn’t nearly as nutritious. Always check the ingredients to see if “whole wheat” or “whole grain” is thefirstingredient listed. And don’t be fooled by how a food looks. For example, some dark brown breads are colored with coffee or other dyes, not whole grains. And remember, whole grain rice is brown, not white rice.
  • Avoid food that is high in sugar, like pastries, sweetened cereal, and soda or fruit-flavored drinks.
  • Reduced-fat or no-fat (skim) milk, reduced-fat cheese, and low-fat or no-fat yoghurt are good sources of the protein and calcium we need. Try to eat 2-4 servings of low-fat or no-fat dairy products each day.

Exercise Does More Than Burn Calories

Increasing the amount of exercise you do each day means you burn more calories to help you lose weight.  And, research has shown very clearly that 30 minutes of moderately strenuous daily exercise is also one of the most important requirements for disease prevention – even for people who are already at an ideal weight.  The exercise you choose doesn’t need to be elaborate, or to take place in a gym.  Walking, biking, swimming, or gardening can do the trick, and getting a friend or family member to exercise with you can turn this into a valued part of your daily routine.  Learn more about the health benefits of physical activity and how to get started from the CDC.

Staying Healthy is a Life-Long Proposition

When we think about dieting, most of us think about setting a weight-loss goal that will determine how long we watch what we’re eating.  A better way to think about it might be to ask yourself the question: How long do I want to try to avoid developing chronic disease? Put in those terms, it’s easy to see that getting control of BMI and eating foods that contribute to continuing good health (or that don’t directly contribute to the development of dangerous disease conditions) is not a short-term goal.  For many of us, doing what it takes to get our BMI into a healthy range and to keep it there means learning to live our lives in a new way. Scientists have found that one of the keys to success is to think about these goals every day. For example, people who get on a scale and check their weight daily are more successful at keeping their weight under control than people who don’t.

Don’t Waste Your Time, Energy, and Money on “Quick Fix” Solutions

For some people, there may be faster ways to lose weight than following the diet suggestions listed here.  But the important thing to remember is that weight loss is not the only goal.  The more important goal is to keep your risk of developing chronic disease and dying younger as low as possible.  Fad diets, diet pills, protein powders, liposuction, and even intestinal or gastric bypass surgery might provide a leaner profile, but they don’t provide the nutrients needed to keep you as healthy as you could be.

For more information about BMI and how it is calculated, see Obesity in America: Are You Part of the Problem? Mozaffarian D, Hao T, Rimm, EB, et al. Changes in Diet and Lifestyle and Long-Term Weight Gain in Women and Men. The New England Journal of Medicine. 2001;364:2392-404.

A very useful demonstration of the trend toward larger portion sizes can be found in the two “Portion Distortion” slide sets that you can view at http://hp2010.nhlbihin.net/portion/.

Some fats that are liquid at room temperature, like coconut oil, are still high in saturated fats. Check the nutrition label before you buy, to be sure that you’re choosing the product with the lowest possible saturated fat content.

Will Acai Help Me Lose Weight?

Diet, Habits, & Other Behaviors
Emily Hartman, Cancer Prevention and Treatment Fund

If you are trying to lose weight to prevent cancer, you may notice that there are claims that the acai (AH-sah-EE) berry will help you lose weight. Dieters beware: these claims are false. Ads promising weight loss have been spotted on popular social networking sites and search engines. Before you give out your credit card number, read on!

The acai palm produces a very small berry that is found in South and Central America. It has become popular in the United States over the last few years. While there are plenty of good things about the fruit, make no mistake-there are no special properties that make you suddenly or quickly lose weight. Acai does have antioxidants-a substance our bodies need-but no more than cranberries or cherries, and less than blueberries, pomegranate, and grapes.[1]

Here are some tips that have been scientifically proven to help you lose weight:

  • Exercise on a regular basis-most days of the week
  • Eat well-balanced, nutritious meals
  • Start each day off with breakfast
  • Get enough sleep (at least 7-9 hours)

It is important to remember that if a product claims fast weight loss, either the product is risky or the claims are false. Healthy, safe weight loss consists of losing no more than two pounds per week-that’s 7,000 fewer calories consumed than burned off each week, since one pound equals 3,500 calories. Weight loss at the rate of .5 to 2 pounds per week is more likely to be permanent. If acai really were a miracle weight loss product, there would be no obesity epidemic in the United States! So please, use your better judgment next time you are tempted to buy an acai weight loss product.

Reference:

  1. Navindra P. Seeram, Michael Aviram, Yanjun Zhang, Susanne M. Henning, Lydia Feng, Mark Dreher, David Heber. Comparison of Antioxidant Potency of Commonly Consumed Polyphenol-Rich Beverages in the United States. Journal of Agricultural and Food Chemistry 2008 56 (4), 1415-1422.