All posts by CPTFeditor

Bacteria: the good, the bad, and the ugly

Diet, Habits, & Other Behaviors
Jennifer Yttri, PhD

Bacteria are everywhere, including your entire body. The bacteria in our body weighs as much as our brain–3 lbs! Bacteria can be harmful, but some species of bacteria are needed to keep us healthy. The bacteria on our skin, in our airways, and in our digestive system are the first line of defense against foreign “invaders” (pathogens) that can cause infection and other problems.

Bacteria also act as “tuning forks” for our body’s immune system, making sure it’s pitched just right. The immune system shouldn’t be too sensitive or too sluggish: it needs to respond quickly to an infection but it shouldn’t over-react. (If it does over-react and attacks the body itself, the result is an autoimmune disease, such as rheumatoid arthritis, lupus, or MS). Each person has a personalized collection of bacteria, called the microbiome.1 We acquire our first bacteria while being born, and every day our environment exposes us to more. Some of these bacteria will take up residence inside the body and help develop a robust immune system.

The Good

The species of bacteria that colonize our respiratory and digestive systems help set up checks and balances in the immune system. White blood cells police the body, looking for infections, but they also limit the amount of bacteria that grow there. Likewise, bacteria keep white blood cells from using too much force. Bacteria also help out by doing things cells are ill-equipped to do. For instance, bacteria break down carbohydrates (sugars) and toxins, and they help us absorb the fatty acids which cells need to grow. 2 Bacteria help protect the cells in your intestines from invading pathogens and also promote repair of damaged tissue. Most importantly, by having good bacteria in your body, bad bacteria don’t get a chance to grow and cause disease.

The Bad

Of course, some species of bacteria in your body can result in diseases, such as cancer, diabetes, cardiovascular disease, and obesity. 3  Usually, these diseases happen only when the normal microbiome is disrupted, but that can occur even from antibiotics. Antibiotics kill bacteria, and some of those will be good bacteria that we need to protect our health. When that happens, the bad bacteria that normally are kept in check have room to grow, creating an environment ripe for disease.

Bad bacteria can exist at low levels in your body without causing harm or can grow too much and wreak havoc. Staphylococcus aureus can cause something as simple as a pimple or as serious as pneumonia or toxic shock syndrome. P. gingivalis can cause gum disease, and was recently linked to pancreatic cancer (read our article find out more). Similarly, when not suppressed by good bacteria, Klebsiella pneumonia can cause colitis, and subsequently lead to colorectal cancer. 4

The Ugly

In addition to allowing disease-causing bacteria to flourish, the elimination of good bacteria throws  the immune system out of whack. The result can be simple allergies or very debilitating autoimmune diseases. Without the right balance of bacteria, your body might suffer from constant inflammation.

Inflammation is the body’s alarm system, which calls white blood cells to heal a wound or to get rid of infection. Chronic inflammation, however, can make the body more susceptible to autoimmune diseases and cancer, such as causing inflammatory bowel disease which if uncontrolled can cause colon cancer. 5

The Future

Research suggests that efforts to make a cleaner environment, free from bacteria, are contributing to the rise in obesity, cancer, and heart disease. 6 Experts are trying to figure out how “probiotics” (foods like yogurt with active cultures and dietary supplements that contain live bacteria) can improve our health. Research is underway so  that in the future, specific bacteria may be prescribed as individually tailored treatments for patients.

Our immune system needs the right combination of bacteria so we can stay healthy and rely less on medications. Antibiotics remain a powerful tool to keep us healthy but shouldn’t be used when they aren’t needed. The more we learn, the more we appreciate the power of the bugs inside of us—to heal and not just to do harm.

Related Content:
Pancreatic cancer: could bacteria in our mouth help us detect this deadly cancer sooner?
Fat moms and fat babies? Weight gain during pregnancy
Ten easy tips to get your family eating healthy

Treatment options for cervical cancer

Cervical Cancer and HPV
This article is from the National Cancer Institute website
Updated 2013

There are different types of treatment for patients with cervical cancer.

Different types of treatment are available for patients with cervical cancer. Some treatments are standard (the currently used treatment), and some are being tested in clinical trials. The purpose of clinical trials are to see if the treatment being tested is better, worse, or equally safe and effective compared to other treatments.* Some clinical trials are open only to patients who have not started treatment. Some clinical trials are open only to patients who have not started treatment.

Three types of standard treatment are used:

Surgery

Surgery (removing the cancer in an operation) is sometimes used to treat cervical cancer. The following surgical procedures may be used:

  • Conization: A procedure to remove a cone-shaped piece of tissue from the cervix and cervical canal. A pathologist views the tissue under a microscope to look for cancer cells. Conization may be used to diagnose or treat a cervical condition. This procedure is also called a cone biopsy.
  • Total hysterectomy: Surgery to remove the uterus, including the cervix. If the uterus and cervix are taken out through the vagina, the operation is called a vaginal hysterectomy. If the uterus and cervix are taken out through a large incision (cut) in the abdomen, the operation is called a total abdominal hysterectomy. If the uterus and cervix are taken out through a small incision in the abdomen using a laparoscope, the operation is called a total laparoscopic hysterectomy.
  • Radical hysterectomy: Surgery to remove the uterus, cervix, part of the vagina, and a wide area of ligaments and tissues around these organs. The ovaries, fallopian tubes, or nearby lymph nodes may also be removed.
  • Modified radical hysterectomy: Surgery to remove the uterus, cervix, upper part of the vagina, and ligaments and tissues that closely surround these organs. Nearby lymph nodes may also be removed. In this type of surgery, not as many tissues and/or organs are removed as in a radical hysterectomy.
  • Bilateral salpingo-oophorectomy: Surgery to remove both ovaries and both fallopian tubes.
  • Pelvic exenteration: Surgery to remove the lower colon, rectum, and bladder. In women, the cervix, vagina, ovaries, and nearby lymph nodes are also removed. Artificial openings (stoma) are made for urine and stool to flow from the body to a collection bag. Plastic surgery may be needed to make an artificial vagina after this operation.
  • Cryosurgery: A treatment that uses an instrument to freeze and destroy abnormal tissue, such as carcinoma in situ. This type of treatment is also called cryotherapy.
  • Laser surgery: A surgical procedure that uses a laser beam (a narrow beam of intense light) as a knife to make bloodless cuts in tissue or to remove a surface lesion such as a tumor.
  • Loop electrosurgical excision procedure (LEEP): A treatment that uses electrical current passed through a thin wire loop as a knife to remove abnormal tissue or cancer.

Radiation therapy

Radiation therapy is a cancer treatment that uses high-energy x-rays or other types of radiation to kill cancer cells or keep them from growing. There are two types of radiation therapy. External radiation therapy uses a machine outside the body to send radiation toward the cancer. Internal radiation therapy uses a radioactive substance sealed in needles, seeds, wires, or catheters that are placed directly into or near the cancer. The way the radiation therapy is given depends on the type and stage of the cancer being treated.

Chemotherapy

Chemotherapy is a cancer treatment that uses drugs to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. When chemotherapy is taken by mouth or injected into a vein or muscle, the drugs enter the bloodstream and can reach cancer cells throughout the body (systemic chemotherapy). When chemotherapy is placed directly into the spinal column, an organ, or a body cavity such as the abdomen, the drugs mainly affect cancer cells in those areas (regional chemotherapy). The way the chemotherapy is given depends on the type and stage of the cancer being treated.

Clinical Trials

New types of treatment are being tested in clinical trials.

Information about clinical trials is available from the NCI Web site.

Patients may want to think about taking part in a clinical trial.

For some patients, taking part in a clinical trial may be the best treatment choice. Clinical trials are part of the cancer research process. Clinical trials are done to find out if new cancer treatments are safe and effective or better than the standard treatment.

Many of today’s standard treatments for cancer are based on earlier clinical trials. Patients who take part in a clinical trial may receive the standard treatment or be among the first to receive a new treatment.

Patients who take part in clinical trials also help improve the way cancer will be treated in the future. Even when clinical trials do not lead to effective new treatments, they often answer important questions and help move research forward.

Patients can enter clinical trials before, during, or after starting their cancer treatment.

Some clinical trials only include patients who have not yet received treatment. Other trials test treatments for patients whose cancer has not gotten better. There are also clinical trials that test new ways to stop cancer from recurring (coming back) or reduce the side effects of cancer treatment.

Clinical trials are taking place in many parts of the country. See the Treatment Options section that follows for links to current treatment clinical trials. These have been retrieved from NCI’s clinical trials database.

Follow-up tests may be needed.

Some of the tests that were done to diagnose the cancer or to find out the stage of the cancer may be repeated. Some tests will be repeated in order to see how well the treatment is working. Decisions about whether to continue, change, or stop treatment may be based on the results of these tests. This is sometimes called re-staging.

Some of the tests will continue to be done from time to time after treatment has ended. The results of these tests can show if your condition has changed or if the cancer has recurred (come back). These tests are sometimes called follow-up tests or check-ups.

This article is from the National Cancer Institute web site.

*Addition by Cancer Prevention and Treatment Fund

October surprise

News Stories & Editorials,
by Diana Zuckerman, PhD
October 2, 2013

In politics, an October surprise is when a candidate has dirt on his or her opponent that is saved for just a few weeks before the election, so that the opponent’s media coverage will be negative just as people are deciding who to vote for.

This year’s October surprise was different, since there are very few elections. This year, the October surprise will be:

  1.  How long will the government be shut down?
  2. Will millions of Americans lose the opportunity to buy affordable health insurance in a bargain to re-open the government or pass the debt ceiling bill?

We live in a Democracy, but the decision about this October’s surprise is going to be made by a very small group of Congressman. How did 2-3 dozen Tea Party Members in the House of Representatives get that power in a Congress of 535 people, and should they be applauded for their principles or shunned for their bullying?

And let’s remember what’s at stake:

  • While the government is closed down, some essential services will continue (such as Social Security checks) but approximately a million workers won’t be paid (a blow to the economy) and services will be curtailed (national parks closed, Social Security, disability, food programs for poor families, and passport services delayed, etc.)
  • U.S. healthcare is the most expensive in the world, and Americans don’t live as long in the U.S. as they do in 16 other countries, including Canada, Portugal, and Japan. The purpose of the Affordable Care Act is to save lives by providing affordable health insurance to millions of Americans.

For those who (understandably) have tried not to think about the crisis, here’s a short “October Surprise for Dummies” version.

  •  The federal government and the services it funds (military, Social Security, cancer research, veterans’ health care, grants to public schools, etc.) is funded for one year at a time, starting Oct. 1 every year. This year, none of the funding bills have passed for the coming year, so the government closed down on October 1.
  • The funding bill for the year starting October 1, 2013 did not pass when it was supposed to (months ago) because 2-3 dozen Tea Party Republicans have refused to vote to support a budget unless it specifically removes funding for the Affordable Care Act, which they derisively call Obamacare.
  • You might ask: don’t we live in a Democracy where a bill in the House of Representatives needs a simple majority (218 votes) of the 435 Members to pass? How can even a few dozen people stop a bill if more than 218 want that law to pass? The answer is that Speaker of the House John Boehner is going by a different set of rules. Instead of allowing a vote for the entire House of Representatives, which would certainly pass a budget that the Senate and President would agree to, the Speaker won’t allow a vote on a bill unless it has the support of a majority of just the Republican Members of Congress – not including the Democrats. For hundreds of years, laws have passed only because of bipartisan cooperation, but that is not even possible now. Without support from enough Tea Party Members, the Republicans can’t get 218 votes to prevent the government from shutting down unless the bill cuts funding for Obamacare.
  • Hence, no bill yet, and a shutdown of most government activities. For example, the Congress made an exception at the last minute for pay for our military, but not disability payments for our veterans. The irony is that even as the government shuts down October 1, the new health care law will continue. In fact, on October 1, millions of people went online or in health centers to figure out which policies to sign up for. Those patients were from all over the country, including the red states that have officially opposed Obamacare.
  • If Congress can come to an agreement to fund the government, the next crisis date is October 17, when our country’s debt ceiling is reached. Our government borrows money every year, because we spend more than our taxes can pay for. Congress then votes for a new amount of debt that it considers acceptable. Like the annual budget, the debt ceiling has been held hostage by the same Tea Party Congressmen (and women) who refuse to vote for it unless – you guessed it – Obamacare is repealed, or at least loses the funding it needs to provide health insurance for people who can’t afford it.
  • And, if Congress comes to a compromise to fund the government temporarily (for 6 weeks, for example), then we will still need to go through this again when the temporary bill expires. That’s why the Democrats have told the Republicans that they want to meet to discuss a compromise for a 1-year funding bill, not a 6-week funding bill.

Is this any way to run a country?

Some people believe that the Tea Party opponents of the 2013 funding bill should be applauded for their principled stand. After all, they ran for office promising to gut the health care legislation. But, what is it about “Obamacare” that’s so terrible that it is worth shutting down the government or letting our country default on the money it owes.

Under Obamacare, health insurance plans now must provide:

  • Prescription discounts for seniors
  • Family insurance policies must cover all children under 26, even if they don’t live at home
  • Starting in January, insurance policies must cover all pre-existing conditions, such as cancer and heart disease. And they can’t stop paying for coverage when a disease gets very expensive (no yearly limits or lifetime limits on coverage, which in the past have bankrupted many families)

Starting in January:

  • States can get free Medicaid coverage for adults and children up to 133% of the poverty level (about $30,000 for a family of 4)
  • People who don’t have insurance through their employer or Medicaid will be able to go to state “Insurance Exchanges” that offer affordable health insurance. The federal government will help pay the annual cost of insurance for people earning up to 400% of the poverty level.

Sounds good, doesn’t it? There is a catch, though. The “mandate” in the law requires every American to buy health insurance, starting in January. The Tea Party hates the mandate, but the penalty if someone doesn’t comply is only $95 for the entire year. That means that those who don’t like the law and don’t want to buy health insurance would get away with the equivalent of a depressingly large parking ticket.

Is a mandate requiring insurance coverage (as is done with car insurance) fair? Unfortunately, it is the only way to keep prices down, because now that pre-existing conditions are covered for health insurance policies, a person could otherwise delay buying health insurance until they know they will have major medical expenses. (That would be like buying retroactive flood insurance to pay for flooding damage that already occurred a major saving for you, but untenable for insurance companies).

And, let’s not forget that Obamacare became law because of the affirmative votes of most Members of Congress, and that the numerous efforts to pass a law repealing it have been unsuccessful, because it does, in fact, benefit millions of Americans.

What will this year’s October Surprise be? Let’s hope it will be a pleasant surprise–a Congress that respects its citizens enough to preserve majority rule–the linchpin of our democracy.

 

This article appeared on the Huffington Post on October 2, 2013.

Choosing wisely: tests and treatments cancer patients usually DON’T need

Medical Treatments with Cancer Risks, , , ,
By Jennifer Yttri, PhD
2013

The thought of cancer is so frightening that many patients depend on their physicians to make all the decisions about screening, prevention, and treatment.  Or they may ask for whatever “new cure” they have heard about.  That can result in too many tests or treatments that do more harm than good.  Not every test, procedure, or medication is appropriate for every patient, and many are over-used. What is beneficial for one person isn’t worth the risks for another.

The best health decisions can be made when physicians take the time to talk with their patients and patients ask questions rather than just assuming the doctor always knows best.

The ABIM Foundation and Consumer Reports collaborated with specialty medical societies to create lists of “5 Things Physicians and Patients Should Question” as part of a national effort called Choosing Wisely (www.choosingwisely.org). These medical groups represent more than 500,000 physicians. The lists contain evidence-based recommendations made by experts. Here is the list of their recommendations on cancer.

Breast cancer screening

Breast cancer screening is done through mammograms, which are like x-rays.  A breast cancer diagnosis involves giving the cancer a stage (0 through 4, with 4 being the most advanced) based on the size of the tumor, how advanced it is, and how likely it is to spread. Other imaging tests, like PET, CT, and bone scans are not recommended for screening early stage breast cancer (stages 0-3), patients newly diagnosed with Ductal Carcinoma In Situ (DCIS), or people without symptoms. This testing does not benefit patients, and false-positives (test results that indicate cancer when no cancer is present) can lead to unnecessary procedures and misdiagnosis. For anyone who has been treated for early-stage breast cancer and is symptom free, mammograms and regular clinical exams are the best ways to check that the cancer has not come back.  Advanced imaging tests and tumor marker tests should only be used for patients with later-stage breast cancer.

Cancer therapy

The first round of cancer therapy works best at reducing or eliminating a tumor. Multiple treatments, including chemotherapy, will not always help get rid of cancer, especially more advanced cancers or tumors that return. After three different treatments, another round is unlikely to improve quality or length of life. It is better to stop therapy and not suffer through the side effects of treatment.  (In fact, there is some evidence that patients live longer, with better quality of life, if they stop aggressive treatments earlier.)

Cervical cancer screening

Women over 65 should stop being screened for cervical cancer if they have not previously shown risk for disease. Women under 30 should not have HPV tests to screen for cervical cancer. Women with mild dysplasia or cervical intraepithelial neoplasia (CIN1) for less than two years should not be treated for cervical cancer, as CIN1 is usually caused by a short-term HPV infection and goes away within a year.   See below for information about HPV testing. Pap smears should be used to screen for cervical cancer.

Colon cancer screening

For people who are at an average risk for developing colon cancer, tests such as stool tests and sigmoidoscopy can be used instead of colonoscopy to screen for colon cancer. Abnormal results from these tests require follow-up with a colonoscopy. The plasma test named methylated Septin 9 (SEPT9) is an alternative screening test but it is not recommended unless the more conventional tests and colonoscopy are not feasible.

HPV testing

HPV testing is not recommended for low risk infections, such as for HPV associated with genital warts. HPV testing should be used to identify high risk infections in patients with abnormal Pap smears or other clinical symptoms associated with high risk HPV infections.

Ovarian cancer screening

Women at average risk who do not have symptoms should not be screened for ovarian cancer. Screening using ultrasound or blood serum testing might detect early signs of cancer, but ovarian cancer is uncommon in women of average risk without symptoms. An abnormal result that isn’t cancer might require invasive follow-up, and those risks outweigh the benefit of early detection.

Ovarian cysts

Small, simple cysts are common in women and usually won’t affect their health. If one is found, the doctor will schedule an ultrasound to determine if the cyst is benign (not cancer). If the cyst is not cancerous, a follow up ultrasound and surgery is not recommended unless the cyst causes symptoms, like pelvic pain. If the cyst is suspected to be cancerous, a follow up ultrasound is not recommended because the cyst should just be surgically removed.  A second ultrasound is only recommended for larger cysts that the doctor could not be sure about.

Palliative care for bone metastasis

Cancers that spread to bones are often very painful. Local radiation is sometimes used to treat patients with one or a few bone metastases, but some doctors question if the increased risk of cancer warrants radiation as treatment for pain. The American Society for Radiation Oncology recommends using one dose of radiation to relieve pain from any bone metastasis. While another dose might be needed in the future, starting with one dose makes sense, since patients with bone cancer have a short life expectancy.

Prostate cancer screening

Men who do not have symptoms generally should not be screened for prostate cancer using a prostate-specific antigen (PSA) test or digital rectal exam as it can lead to treatments that may do more harm than good. Gleason and prostate-specific antigen (PSA) tests are used to measure how aggressive prostate cancer is and how likely it is to spread. Imaging tests can then be performed to identify exactly where cancer has spread. These imaging tests, such as bone scans, PET, and CT, are not recommended for detecting disease in men who are newly diagnosed with low-grade prostate cancer. Imaging tests are expensive, can expose men to high levels of radiation, and are unlikely to provide more information about early prostate cancer. Only men with Gleason scores above 7 and PSA levels above 10 nanograms/mL should consider imaging tests.

Prostate specific antigen (PSA)

High PSA levels may be a sign of prostate cancer. However, having a low PSA level does not prevent prostate cancer nor does it mean there is no cancer. It was thought that antibiotics might lower PSA and protect men from prostate cancer. This has not been proven in clinical tests and is not recommended as an alternative preventive therapy.

Stage 1 non-small cell lung cancer (NSCLC)

Lung cancer is the most common type of cancer to spread to the brain. However, the chance of patients with Stage 1 lung cancer developing brain metastasis is very low. Because of the rate of false positives is much higher than the actual rate of brain metastasis, brain imaging by MRI or CT is not recommended for patients with stage 1 NSCLC unless they have neurologic symptoms.

Thyroid scans

Radioactive iodine is absorbed by the thyroid and can be used to give doctors a picture of what the thyroid looks like, how it is functioning, and if there are any nodules in the area. Imaging with radioactive iodine is not recommended for determining whether thyroid nodules are benign or cancerous unless the patient is hyperthyroid. Nodules should be biopsied if the thyroid functions normally.

2013 Stop Cancer Now 5K Run/Walk and 1-Mile Fun Run on Sunday, September 22 at 10 a.m.

5K, Events

Early Packet Pick-up is Saturday September 21: Get your T-shirts and Bibs ahead of time and receive a 20% coupon off all REI products – @ Georgetown Running Company, Saturday 9/21, 12pm-4pm
Georgetown Running Company Address: 3401 M St. NW
Washington, DC 20007 (in Georgetown)

Race Registration/Start/Finish: At the corner of Potomac St. NW and Grace St. NW in Georgetown, Washington, DC on the Potomac River side of the Canal. Start/Finish is on the C&O Canal Trail near the end of 33rd St. NW access road.

Potomac St NW & Grace St NW
Washington, D.C., DC 20007

Note: If you are using GPS, closest street address is: 1000 Potomac Street NW, Washington, DC 20007. (This will get you to the access street where registration is, but park before turning onto Potomac Street):

Check-in and Same Day Registration/Packet Pick-up: On the brick area at Potomac St. NW & Grace St. NW (access off of K St. NW if driving OR can access via foot bridge from M St. NW directly behind Dean and Deluca). Race day check-in is from 8:45 a.m.-9:45 a.m. Bag check will be next to the check-in/registration tables. IMPORTANT: Arrive early for good parking! (Parking is free!)

Pre-Race Warm Up: At 9:30 a.m. led by Fitness Together (near the check-in area). Look for Fitness Together sign, and warm up will be announced 5 minutes before.

Race Day Food and Fun: The North Face will be providing their Demo Shoe program during the race along with free reusable water bottles. Try on a pair of their running shoes, run or walk the 5K, then return! There will be North Face representatives there to help with sizing or questions about purchasing.

Food and coffee provided by Starbucks, Harris Teeter, and Trader Joe’s

Stroller Policy: Strollers allowed on race day!

For Everyone’s Safety: Competitive runners please make your way to the start line at 9:45 a.m. Anyone with strollers or children, please line up behind.

Pace: This is a flat and fast course. Although there will be plenty of space along the canal (with some narrow spots along the course), please be mindful of your fellow runners and walkers and stay to the right side of the trail.

Age Divisions: 14 and under, 15-19, 20-24, 25-34, 35-44, 45-54, 55-64, 65+

Prizes: The top female and male runners in each age category will receive a prize. All children 13 and under registered for the race will receive a blue ribbon.

Metro details (Orange and Blue lines): Rosslyn Metro opens at 7a.m. It is a 15 minute walk from the Rosslyn Metro across the Key Bridge into Georgetown to get to the start of the race.

Bus Details: DC Circulator, Metrobus lines: 31, 32, 36, 38B, D1, D2, D3, D5, D6, G2. Circulator opens at 7 a.m.
Visit Trip Planner on www.wmata.com to find the fastest and easiest route.

Testimony of Brandel France de Bravo, MPH, at the Gastroenterology-Urology Devices Panel on Computed Tomography Colonography (Virtual Colonoscopy)

Policy, Testimony & Briefings,
September 9, 2013

I am Brandel France de Bravo, and I am speaking on behalf of the Cancer Prevention and Treatment Fund of the National Research Center for Women & Families. Our non-profit research center scrutinizes medical data, evaluating scientific evidence of benefits and risks for patients.  We analyze and review research and provide objective and understandable health information to patients, health care providers, and policy makers.  Our organization does not accept funding from companies that make medical products, and therefore I have no conflict of interest.

The research presented in the FDA summary makes clear five points that are essential in considering the benefits and safety of Computed Tomography Colonography or CTC:

1)      There is NO ONE method of screening asymptomatic patients for colon cancer that meets the three necessary criteria for increasing compliance with screening guidelines: that the method be highly accurate; very low risk; and involve little to no discomfort—either physical or psychological – including the “yuck”  factor. Optical colonoscopy has not been as widely embraced as many health experts would have liked, except perhaps by unscrupulous surgical centers, which The New York Times reports are charging insurance companies as much as $6,000.   The Times noted that colonoscopies “are the most expensive screening test that healthy Americans routinely undergo — and often cost more than childbirth or an appendectomy in most other developed countries.” While traditional colonoscopy has downsides, it at least offers a “two-for”: it screens patients for colon cancer and removes potentially pre-cancerous polyps all in the same procedure.

2)      Virtual colonoscopies don’t screen and treat; they just screen, which is why the term “virtual colonoscopy” is a misnomer. It is, however, a great marketing tool as it implies a clean, no-muss-no-fuss approach. In fact, patients still have to go through the grueling process of bowel preparation.

3)      CTC is not as good as optical colonoscopy at detecting polyps or lesions of 10 mm or smaller. This, however, may not be so important given that polyps under 10mm are less likely to be suspicious and in need of removal. Smaller polyps grow slowly, and some will even shrink and disappear on their own.

4)      While CTC is less sensitive for smaller lesions and exposes patients to relatively high doses of radiation, it does offer one major benefit over colonoscopy: it reduces the risk of major bleeding and disease transmission—both of which are of particular concern in older patients.

5)      Besides exposing patients to radiation and missing smaller polyps, CTC opens a Pandora’s box of “extra-colonic findings”—suspicious findings in nearby organs. These findings can lead to more diagnostic tests, some of which may be invasive or harmful, but they also sometimes save lives.

While radiologists often dismiss worries about excessive exposure to radiation, our Center continues to be concerned because so many patients are being exposed to radiation from so many different medical tests, as discussed today by Dr. Berrington de González. Two pieces of information or safeguards that would help make the decision about CTC easier are missing:

  • We need to know if patients in the U.S. are more likely to undergo regular screening with so-called virtual colonoscopies than regular ones. This is the purpose of patient-centered outcomes research—how do real patients in the real world respond to these two options, and what are the benefits of each in attracting patients who should get screened?Dr. Summers shared data on patient acceptance, showing a preference for CTC, but that data was based on answers to questionnaires—given either after the procedure or about a hypothetical screening.  To date there are no studies in the U.S. where asymptomatic patients who have never before been screened are given a choice between CTC and regular colonoscopy and then actually undergo their preferred screening.
  • When is a professional society or government agency going to address the health threat of increased lifelong exposure to radiation from medical tests and treatments? The advent of electronic medical records provides the opportunity to implement a plan to reduce patients’ total exposure to radiation. It wouldn’t cap exposure but rather allow providers to make informed decisions: by enabling them to review a patient’s previous radiation exposure before choosing what kind of screening to recommend.  For example, a heavy smoker undergoing regular CT scans for her lungs should probably be screened with colonoscopy rather than CTC, since the latter also exposes part of the lungs to radiation.

There are no easy answers, but we trust the US Preventive Services Task Force to stay on top of this important issue, providing unbiased information on the risks and benefits as new data become available.  We agree with the Task Force that at this point, there is no reason to recommend virtual colonoscopies for most patients who need screening.  We would add, however, that if specific patients are unwilling to undergo regular colonoscopies, then a virtual colonoscopy is a reasonable alternative.

 

New concerns on robotic surgeries

News Stories & Editorials
by Rani Caryn Rabin, The New York Times
September 9, 2013

In early March 2009, Erin Izumi, a woman in her 30s from Tacoma, Wash., underwent robotically assisted surgery to treat endometriosis. The operation at St. Joseph Medical Center dragged on for nearly 11 hours.

Ten days later, Ms. Izumi was rushed to an emergency room, where doctors discovered that her colon and rectum had been torn during the operation. She was hospitalized for five weeks, undergoing a series of procedures to repair the damage, including a temporary colostomy, according to her attorney Chris Otorowski.

But even though medical device manufacturers and hospitals are required to report every device-related death and serious injury to a database maintained by the Food and Drug Administration within 30 days of learning about an incident, no report about the case was made in 2009. Hospital officials declined to comment, and a spokeswoman for the manufacturer said it became aware of the incident only when Ms. Izumi filed a lawsuit. It disputed the claim and settled the case in May 2012.

That was not the only lapse in reporting problems with robotic surgical equipment, a new study has found.

The equipment, called the da Vinci system, is made by Intuitive Surgical Inc. of Sunnyvale, Calif. It has been on the market for more than a decade; more than a million procedures have been performed with it. Between January 2000 and August 2012, thousands of mishaps were reported to the F.D.A. In the vast majority of cases, the patient was not harmed, but among the reports were 174 injuries and 71 deaths related to da Vinci surgery, according to a study published last week in The Journal for Healthcare Quality.

Yet by combing news reports and court records, researchers at Johns Hopkins were able to find examples of botched operations that were not reported to the agency. They concluded that adverse events associated with the da Vinci were “vastly underreported.”

It is fairly well known that reports made to the F.D.A. represent only “the tip of the iceberg” of surgical complications and adverse drug reactions, said Diana Zuckerman, the president of the National Research Center for Women and Families and an expert on the safety of medical devices, who was not involved in the study. The consequence is that little is known of the real disadvantages of the equipment, and the injuries and deaths it may cause, even as robotic surgery is widely marketed to consumers, Dr. Zuckerman said.

In a statement, Angela Wonson, vice president of corporate communications at Intuitive, said that the new study “gives the misleading impression that Intuitive Surgical has systematically failed in its obligation to timely report known adverse events to the F.D.A.” On the contrary, she said, “We take this requirement very seriously and make every effort to account for all reportable events — even those from several years prior.”

The new study follows a series of reports critical of robotically assisted surgery. Documents surfacing in the course of legal action against Intuitive have outlined the aggressive tactics used to market the equipment and raised questions about the quality of training provided to surgeons, as well as the pressure on doctors and hospitals to use it — even in cases where it is not the physician’s first choice and she has little hands-on experience.

Nevertheless, robotic surgery has grown dramatically, increasing more than 400 percent in the United States between 2007 and 2011. About 1,400 da Vinci systems, which cost $1.5 million to $2.5 million, have been purchased by hospitals, according to Intuitive’s investor reports.

The expansion has occurred without proper evaluation and monitoring of the benefits, said Dr. Martin A. Makary, an associate professor of surgery at Johns Hopkins and the senior author of the paper.

“This whole issue is symbolic of a larger problem in American health care, which is the lack of proper evaluation of what we do,” Dr. Makary said. “We adopt expensive new technologies, but we don’t even know what we’re getting for our money — if it’s of good value or harmful.”

Part of the problem is that the reporting mandate “has no teeth,” Dr. Makary added. “In health care, one fifth of the economy, we have this haphazard smattering of reports that relies on voluntary self-reporting with no oversight, no enforcement and no consequences.”

F.D.A. officials said in a statement that the agency has issued warning letters in the past when facilities have failed to report, and that the agency can take further regulatory actions like injunctions or imposing civil financial penalties.

A 2010 study found that 56.8 percent of surgeons surveyed anonymously said they had experienced irrecoverable operative malfunctions while using the da Vinci system, Dr. Makary noted.

Women were more likely to be harmed during the robotic procedures, Dr. Makary and his colleagues found. Nearly one-third of deaths that were reported to the F.D.A. database occurred during gynecologic procedures, and 43 percent of the injuries were associated with hysterectomies.

“Any time there is a serious problem with the da Vinci, it should be reported,” Dr. Zuckerman said. “It’s the F.D.A.’s job to figure out whether this is a problem related to the device or a doctor error.”

Click here to view the original article on nytimes.com.

Comments of the Patient, Consumer, and Public Health Coalition on Proposed Order “General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products”

Testimony & Briefings, ,
August 7, 2013
[Docket No. FDA-2013-N-0461]

As members of the Patient, Consumer, and Public Health Coalition, we urge you to finally follow the recommendations made by FDA classification panels[end The General and Plastic Surgery Device Classification Panel and the Physical Medicine Device Classification Panel.] in 1977 and upclassify sunlamp products. All sunlamps should be reclassified as Class III devices because of their known risks, especially the increased likelihood of developing the most serious type of skin cancer.

By law, high-risk devices that can cause substantial harm or even death are Class III.  Clearly, sunlamps satisfy those criteria.

Over 30 million Americans, including 2 million adolescents between age 11 and 18, use tanning devices each year. Those who began using tanning beds before age 30 are 75 percent more likely to develop cutaneous melanoma, a potentially fatal cancer. There are virtually no medical benefits to using sunlamp products.  Despite claims, there is no clear evidence that sunlamp products are safe and effective for treating depression, seasonal affective disorder, or vitamin D deficiency. A device that has only minor cosmetic benefits and that the World Health Organization’s International Agency for Research on Cancer has called “carcinogenic to humans” is a threat to public health and should be more strictly regulated.

While we agree with the FDA that sunlamp products should be reclassified, we do not agree that the proposed special controls will adequately protect consumers from the harms associated with indoor tanning. We strongly urge the FDA to require the following safeguards:

  1. Sunlamp products currently are allowed to use a mix of UVA and UVB rays. FDA should set a standard for the UVA/UVB mix that is based on scientific research. Performance testing should disclose the percent of UVA and UVB rays used and this information should be included in labeling.
  2. Because of how sunlamps are used, even the best labeling would not be sufficient to inform consumers of the risks of using sunlamp products. Patients should have to read and sign a patient disclosure form prior to a tanning session. This disclosure form, written at a 6th grade reading level,  should briefly describe the risks of indoor tanning, skin cancer warning signs, and recommended limits on using sunlamps for tanning. Copies of the disclosure form should be given to consumers to take home.
  3. Tanning facilities should be required to post very visible warning information about cancer risks in waiting/reception areas and also on or near the machine itself.
  4. The American Academy of Pediatrics and American Academy of Dermatology both recommend banning minors from tanning salons. We strongly agree.  If no ban is imposed, parents should be required to sign informed consent forms in person at the time a minor is using the tanning facility.
  5. The FDA should consult with scientific advisors to create a recommended limit on sunlamp use for tanning. The limits should include time per exposure, amount of UV radiation per exposure, and number of exposures per year. Customers should be limited to a number of minutes per year that the FDA advisors consider safe. Recommended limits should be included on labels, posted warnings, and patient disclosure forms. Safety and performance testing of sunlamp products should meet the limits.

The classification of sunlamp products should reflect the known safety risks and lack of medical benefits of these devices. Skin cancer is preventable, and requiring higher safety standards for unsafe devices will reduce healthcare costs and save millions of Americans from developing this disease.

 

American Medical Women’s Association
American Public Health Association
Cancer Prevention and Treatment Fund
Connecticut Center for Patient Safety
National Consumers League
National Physicians Alliance
National Women’s Health Network
Our Bodies Ourselves
Center for Science and Democracy, Union of Concerned Scientists
WoodyMatters

 

For more information, contact Paul Brown at (202) 223-4000 or pb@center4research.org

Letter to the editor: Still working to understand cancer

News Stories & Editorials
Diana Zuckerman, PhD
August 5, 2013

Originally published in The Washington Post

The Post article on the overdiagnosis of cancer clearly reported the need to reduce patients’ fear and confusion about “cancers” that many experts now agree are not really cancer, because they don’t spread and aren’t harmful [“Panel addresses overdiagnosis of cancer,” news, July 30]. The major obstacle has been uncertainty about how likely these conditions are to predict cancer or change into an invasive cancer in the future. That is part of the reason many patients are choosing overtreatment, such as bilateral mastectomies that are not recommended and are not medically necessary.

In 2003, our center brought together nationally respected experts to the National Cancer Institute to address these issues. There were substantial disagreements, but for the sake of women across the country, none of us gave up. Let’s hope we make more progress in the coming months and years than we have in the past decade.