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Fast Food Facts: Calories and Fat

Blossom Paravattil, Cancer Prevention and Treatment Fund

Fast Food Facts

Let’s face it: With so much to do, it’s hard to eat right on the go.  And no matter how compelling you found the movies Fast Food Nation or Super Size Me, you sometimes find yourself making the occasional purchase at the nearest Wendy’s. While avoiding fast food may be the wisest and most health-conscious option, it may not be the most realistic.

With so many Americans being obese, President Obama signed a new law into the health care reform bill that requires every big restaurant chain (more than 20 stores) to post calorie information on every menu and drive-thru sign, as well as the amount of calories a healthy person should eat. The bill went into effect in this year.  The law also requires vending machines to have nutritional information on them

How Many Calories Should I be Consuming in a Day?

The United States Department of Agriculture (USDA) has recommended dietary guidelines that include the number of calories you should consume a day, depending on your age, level of activity, and whether you are a man or woman. The chart below will help you find out how many calories you should be getting. If you regularly consume more than the recommended amount, you will gain weight.

Recommended Daily Calorie Intake by Gender and Age based on Activity Level

Activity Level

Gender

Age (years)

Sedentary

Moderately Active

Active

Child

2-3

1,000

1,000-1,400

1,000-1,400

Female

4-8
9-13
14-18
19-30
31-50
51+

1,200
1,600
1,800
2,000
1,800
1,600

1,400-1,600
1,600-2,000
2,000
2,000-2,200
2,000
1,800

1,400-1,800
1,800-2,200
2,400
2,400
2,200
2,000-2,200

Male

4-8
9-13
14-18
19-30
31-50
51+

1,400
1,800
2,200
2,400
2,200
2,000

1,400-1,600
1,800-2,200
2,400-2,800
2,600-2,800
2,400-2,600
2,200-2,400

1,600-2,000
2,000-2,600
2,800-3,200
3,000
2,800-3,000
2,400-2,800

Source: HHS/USDA Dietary Guidelines for Americans, 2005 

Sedentary means a lifestyle that includes only the light physical activity associated with typical day-to-day life. Moderately active means a lifestyle that includes physical activity equivalent to walking about 1.5 to 3 miles per day at 3 to 4 miles per hour, in addition to the light physical activity associated with typical day-to-day life.  Active means a lifestyle that includes physical activity equivalent to waling more than 3 miles per day at 3 to 4 miles per hour, in addition to the light physical activity associated with typical day-to-day life. The calorie ranges shown are to accommodate needs of different ages within the group. For children and adolescents, more calories are needed at older ages. For adults, fewer calories are needed at older ages. So we at the Cancer Prevention and Treatment Fund give you the skinny on a variety of menu choices offered by some of the most popular fast food chains. Take a look–you may be surprised!

Fast Foods by Category

Pizza: Calories Fat
California Pizza Kitchen Original BBQ Chicken (whole pizza) 1136 19 grams
Domino’s Medium Ultimate Deep Dish EXtravaganZZa Feast, 1 slice 12″ 320 16 grams
Domino’s Cheese, 1 slice 12″ 210 8 grams
Papa John’s Garden Fresh on Original Crust, 1 slice 12″ 200 7 grams
Papa John’s Spinach Alfredo on Original Crust, 1 slice 12″ 210 8 grams
Pizza Hut Thin n’ Crispy, Pepperoni, 1 slice 12′ 200 9 grams
Pizza Hut Fit n’ Delicious Pizzawith Green Pepper, Red Onion, and Diced Tomato, 1 slice 150 4 grams
Hamburgers: Calories Fat
Burger King Whopper (with cheese) 770 48 grams
Five Guys (with cheese) 610 34 grams
McDonald’s Quarter Pound with cheese 510 26 grams
Wendy’s ¼ Pound Single Hamburger 470 21 grams
Chicken Strips: Calories Fat
Burger King 8 Piece Chicken Tenders 360 21 grams
McDonalds Chicken Selects Premium Breast Strips (5) 660 40 grams
Wendy’s 10 Piece Chicken Nuggets 450 29 grams
French Fries: Calories Fat
Burger King Medium Fries 440 22 grams
Five Guys 310 15 grams
McDonald’s Medium Fries 380 19 grams
Wendy’s Medium Fries 410 19 grams
Burritos: Calories Fat
Baja Fresh Chicken Burrito Ultimo 880 36 grams
Baja Fresh Bean and Cheese Burrito 840 33 grams
Chipotle Chicken (with rice, beans, sour cream and cheese) 950 37 grams
Taco Bell Burrito Supreme, Chicken 390 12 grams
Sandwiches: Calories Fat
Burger King Tender Grill Chicken (no mayo) 410 7 grams
McDonald’s Premium Grilled Chicken Classic 420 10 grams
Panera Turkey Artichoke Panini 750 24 grams
Panera Bacon Turkey Bravo 830 29 grams
Quiznos Honey Mustard Chicken Sub, Regular 830 41 grams
Quiznos Tuna Melt, Regular 1220 94 grams
Subway Turkey, 6 inch (no mayo) 280 3.5 grams
Wendy’s Ultimate Chicken Grill 370 7 grams
Salads (no dressing): Calories Fat
Burger King Tendergrill Chicken Garden 300 10 grams
McDonald’s Premium Southwest Salad with Grilled Chicken 320 9 grams
Panera Greek Salad 380 34 grams
Panera Strawberry and Poppyseed Chicken Salad 280 8 grams
Quiznos Chicken Caesar, Regular 440 16.5 grams
Quiznos Raspberry Chipotle Chicken, Regular 520 25 grams
Subway Oven Roasted Chicken, Fat-Free Italian dressing 130 2.5 grams
Wendy’s Mandarin Chicken Salad 390 16 grams
Muffins: Calories Fat Sugar
Au Bon Pain Cranberry Walnut 540 25 grams 28 g
Dunkin Donuts Blueberry 510 16 grams 51 g
Dunkin Donuts Honey Bran Raisin 500 14 grams 48 g
Starbuck’s Blueberry 470 24 grams 23 g
Starbuck’s Lowfat Blueberry 430 2.5 grams 57 g
Donuts: Calories Fat Sugar
Dunkin Donuts Glazed Donut 220 9 grams 12 g
Krispy Kreme Original Glazed Donut 200 12 grams 10 g
Starbuck’s Old-fashioned Glazed Donut 420 21 grams 34 g
Bagels: Calories Fat
Dunkin Donuts Everything 350 4.5 grams
Einstein’s Asiago Cheese Bagel 310 5 grams
Einstein Everything 270 2 grams
Starbuck’s Plain 300 1 gram
Other Breakfast: Calories Fat
Burger King Sausage, Egg, and Cheese Biscuit 550 37 grams
Dunkin Donuts Egg and Cheese Bagel 510 6 grams
McDonald’s Sausage McMuffin with Egg 450 27 grams
Starbuck’s Cheese Danish 420 25 grams
Starbuck’s Banana Walnut Loaf 350 16 grams
Coffee: Calories Fat Sugar
Dunkin Donuts Mocha Swirl Latte (10 oz) 220 6 grams 32 g
Dunkin Donuts Coolatta with Skim Milk (16 oz) 210 0 grams 49 g
Dunkin Donuts Latte (10oz) 120 6 grams 10 g
Dunkin Donuts Coffee (14oz), (no milk or sugar) 10 0 grams 0 g
Starbuck’s Caramel Frappuccino, Grande with Whip 390 15 grams 59 g
Starbuck’s Caffè Mocha, Grande 2% Milk, no Whip 260 8 grams 31 g
Starbuck’s Caffè Latte, Grande 2% Milk 190 7 grams 17 g
Starbuck’s Coffee Frappuccino Light 110 0 grams 23 g
Starbuck’s Caramel Macchiato, Grande 240 7 grams 31 g
Where to find this information?

Several fast food chains and restaurants have their nutrition information on their websites. If your favorite foods are not listed above, go to the chain’s website and look for the calorie information. You may be shocked…or pleasantly surprised! Remember: knowledge is power. Knowing how many calories are in your favorite snack or meal-on-the-go can help you watch your weight and stay health.
Reference:

1http://healthreform.gov/documents/title_iv_prevention_of_chronic_disease.pdf

2 USDA. (2008). Dietary Guidelines for Americans 2005.

What’s a Woman to Eat?

Susan Dudley, PhD and Jacqueline Britz, Cancer Prevention and Treatment Fund

The Women’s Health Initiative (WHI) began in 1992 as a long term national health research effort focused on disease prevention among postmenopausal women.  Over 161,000 women have participated in this research, which has provided information that has saved lives of women across the country.  The original study, lasting 15 years, was aimed at finding evidence-based strategies for prevention of many health conditions, including heart disease, breast and colorectal cancer, and fracture in postmenopausal women.  The WHI Extension Study, carried out from 2005 to 2010, followed up with 115,400 participants from the original study to gather more data and answer additional questions.

Many experts were disappointed when a 2006 dietary trial that was part of the original WHI study showed that a low-fat diet did not reduce women’s risks of heart attacks, strokes, breast cancer, or colon cancer.  Since then, other studies have come out, including subsequent diet trials with women enrolled in the WHI.  The results have been inconsistent: some positive and some negative.

So, what’s a woman to eat?  Is there, in fact, a right combination of fats, carbohydrates, proteins, and other nutrients?  Studying and understanding the effects of diet and changes to diet is always complicated.  Consider the following:

  • Any time we limit our intake of one type or category of food, we tend to fill the gap by eating more of another type of food.  In the WHI, women were not encouraged to cut calories or lose weight.
  • Our bodies have an astonishingly efficient “thermostat” that works hard all our lives to return us to whatever body weight and body composition it has been set at, based on what has been normal for us over the long-term.  That is why keeping weight off after just about any kind of crash diet is so hard to do.

The Women’s Health Initiative: Diet Trials

The main goal of the initial WHI dietary trial was to determine whether low-fat diets could reduce the risk of developing breast cancer, colon cancer, stoke, and heart disease.

The 19,541 women participating in the low-fat diet trial were divided into two groups: one group was encouraged to continue eating as they always had, while study participants in the other group were encouraged (through participation in a series of training sessions) to modify their diets by reducing fat and increasing their consumption of fruits, vegetables, and grains.  By later comparing the rates of health problems, including breast and colon cancer and cardiovascular disease, between the two groups of women, scientists hoped to see whether the training sessions would work and whether the low-fat diet would improve women’s health.

The results, reported in 2006, were not encouraging, since few differences emerged in the health status of the women in the two groups.  However, there were a number of weaknesses in the investigation that made the results difficult to interpret.  Two are especially important:

  • All dietary fat is not alike. For example, we now know that saturated fats and trans-fats can have particularly negative health effects and that certain fats-like those found in walnuts or some fish oils-can actually be beneficial. However, the trial did not attempt to influence which types of fats the women were eating.
  • The women who were in the group that was trained to improve their diet didn’t improve their diet as dramatically as the researchers hoped. The “low-fat” group for this study averaged 29% calories from fat instead of the targeted 20%. The 29% finding is not much different from the average adult in the U.S. who gets 32.7% or more of his or her calories from fat. The study participants’ reported consumption of fruits and vegetables was only slightly raised, and their consumption of grains did not change. It’s impossible to know if there would have been a bigger difference in the incidence of cancer, stroke, and cardiovascular disease in the two groups if the “low-fat” group had improved their eating habits more dramatically.

When the researchers studied the women in the diet modification group whose total fat intake was reduced the most, they found that they didsignificantly lower their risk for invasive breast cancer.  And those who consumed less saturated fat and ate more fruits and vegetables reduced their blood pressure, cholesterol and other problems that may eventually reduce their risk of heart attack, stroke, and heart disease.

Results from More Recent Studies

Since the publication of the initial results in 2006, subsequent diet trials with women enrolled in the WHI have shown a mix of positive and discouraging results.  Below are descriptions of four additional trials. While these studies also have limitations, their findings have implications for disease prevention among women.

Low-Fat dietary pattern and Cancer incidence (2007):

The same group of women from the original WHI study was followed for 8 years for a trial that investigated low fat dietary patterns and their effect on cancer incidence.  Despite the discouraging results from the first published investigation on the effects of a low-fat diet, this study found lower rates of ovarian cancer among the group of women who followed a low-fat diet.  For every 100,000 participants on a modified low-fat diet per year, there were 36 cases of ovarian cancer diagnosed, compared to 43 cases of ovarian cancer among the women who did not modify their diet.  This difference in ovarian cancer rates between the two groups was statistically significant, meaning that it was unlikely to have happened by chance.  So, while a low-fat diet was not associated with a reduced risk of breast cancer, colorectal cancer, or cardiovascular disease, it was associated with a lower risk of ovarian cancer.

Low-Fat dietary pattern and risk of treated Diabetes Mellitus in postmenopausal women (2008):

The same participants from the original 2006 trial were also subjects of an 8 year long investigation looking at the relationship between a low-fat diet and diabetes.  Just as was true in the initial trial, the group of women following a low-fat diet did not appear to have substantial health gains over the group of women who did not follow the low-fat diet.  The participants with a modified diet had only a 4% reduced risk of developing diabetes as compared with the participants in the usual diet group.  While that may not seem very impressive, the participants in the low-fat diet group maintained a lower weight, on average, than participants in the usual diet group.  The researchers noted that the participants with the biggest reduction of fat in their diets did have a lower diabetes risk that was statistically significant.  Based on this study, they concluded that losing weight is more important for reducing one’s chances for developing diabetes than the quantity of fat, carbohydrates or other nutrients consumed.  The women in the study who followed a low-fat diet were more likely to maintain a lower weight and, therefore, indirectly may have a reduced their risk of diabetes.

Calcium/Vitamin D supplementation may help prevent weight gain in postmenopausal women (2007):

A large portion of the participants from the initial 2006 trial were used for another study published in 2007 to determine the influence of calcium and vitamin D on weight gain.  Research suggests that these two nutrients may be able to initiate the decline of fat cells, reduce the generation of new fat cells, and consequently decrease the amount of weight gain.  For 7 years, researchers monitored a group of women taking pills with active calcium plus vitamin D, and others taking placebos.  The women taking pills with active calcium plus vitamin D gained on average about a quarter of a pound less than women in the placebo group.  Although this tiny difference was statistically significant, it isn’t a meaningful difference.   More important, the women in this first group were less likely to gain weight at all during the trial.  The women who benefited the most were those who, prior to the start of the study, consumed less than the recommended 1,200 mgs per day of calcium (this is the amount recommended for women in the age range of 50-79). Therefore, while taking active calcium and vitamin D may help women maintain their weight, its benefits are likely to be more substantial in women who lack sufficient calcium and vitamin D.

Multivitamin use and risk of Cancer and Cardiovascular Disease (2009):

Finally, a 2009 study used data collected from all participants in the Women’s Health Initiative throughout the hormone trials, observational study, and dietary study (a total of 161,808 participants).  Study enrollment took place between 1993 and 2008, with follow up conducted through 2005.  Data were collected for a median of 8 years in the clinical trials and 7.9 years in the observational study.  Participants using multivitamins (41.5%) were compared to participants not taking multivitamins to see which group had higher rates of breast, colorectal, endometrial, renal, bladder, stomach, lung, and ovarian cancer.  Researchers were also interested in seeing if there was a difference between the two groups in terms of cardiovascular events such as stroke or heart attack.  The women who took a daily multivitamin were no less likely to develop or die from cancer or cardiovascular disease than the women who did not take a multivitamin.

What We Have Learned from These Studies

Don’t let the negative headlines of some of these studies fool you.  Although these studies provide conflicting results, with only some supporting the relationship between certain diets and disease prevention, and others proving inconclusive, the studies taken altogether still provide a lot of important information:

  • Women whose fat intake was lowered the most had better health outcomes.
  • The women in the WHI were not encouraged to reduce their calories.  That may have been a mistake.  Research now clearly shows that being overweight increases the risk of breast cancer, heart disease, arthritis, and many other diseases, so more targeted dietary modifications that include emphasis on achieving and maintaining healthy body weight might be more effective.
  • Even when evidence does not conclusively show that a particular kind of diet, such as low-fat, can prevent or reduce the risk of disease, the dietary change may still improve health by lowering or controlling weight.  Excess weight and obesity increase the risk for many diseases and cancer.
  • There is no way to know whether the dietary intervention in this study would have been more effective if it had been started earlier in the women’s lives-when the women were in their 20’s, 30’s, or 40s, rather than at 50-79 years of age.
  • We know that many cancers and other health conditions take 15-20 years to develop and usually show up among older individuals.  We still don’t know what impact dietary modifications will have on the women’s health 10 years after the study’s end.
  • One of the most important messages is that dietary changes are easier to talk about than to do something about.  The participants in the dietary modification groups probably started out with very good intentions about following the recommended diet, but that turned out to be impossible for many of them.  Whether this is because of pressure to join the family for dessert, the endless temptation created by advertisements for foods that were not compatible with the diet, or other causes, it is important for us to take such real-world obstacles into account.  It doesn’t make sense to measure the effectiveness of dietary change by focusing on women in a “diet modification group” if the women didn’t substantially modify their diet.   It makes more sense to study the women who succeeded in modifying their diet compared to those who didn’t. Those are the women whose health tended to benefit most.

Maintaining moderation and balance

So, given the findings of these various studies, are there changes in our diet that we should make?  Even though the results are mixed, it’s clear that most people will benefit from a well-balanced diet that is low in sodium, added sugars, and saturated- and trans-fats, and a diet that is high in fresh fruits, vegetables, whole grains, and heart-healthy unsaturated fats, with moderate amounts of dairy products and meat protein.  The USDA Dietary Guidelines for Americans gives specific recommendations for dietary intake, suggesting that women should strive to consume between 1.5 and 2 cups of fruit each day, between 2 and 2.5 cups of vegetables, and 3 cups of low fat milk products.  Women should eat approximately 6 oz. of grains each day (with a minimum of 3 oz. coming from whole grains), and between 5 and 5.5 oz. of meat/beans.  “Good” fats, found in fatty types of fish (i.e. salmon, herring, sardines), plant oils like extra-virgin olive oil, avocados, seeds, and nuts, are also an essential part of a healthy diet and have been found to help prevent incidence of disease.

General guidelines for healthy eating may need to be modified to accommodate specific health problems or disease risks.  For example, people with high cholesterol may need to reduce the amount of fat and food they consume each day that comes from animals (red meats, eggs, and dairy products).  Helpful nutritional guidelines are available at: http://www.mypyramid.gov/index.html.

Also, do not forget to watch calories, because excess weight can cause or complicate so many health problems.  Reaching and maintaining a healthy body weight is important.  In order to lose weight, it is important to make sure that a person burns more calories than he or she consumes.  As a result it is essential to find a healthy balance between food consumption and physical activity.

Remember that serving size and portion size are not the same thing. Serving size is a standardized quantity of food that we use to measure nutrients.Portion size is the amount we pile on our plates.  Keep in mind that one serving of cooked vegetables is usually about one-half cup (about a hand-full!) and a serving of meat is about the size of a deck of cards.  This means that most people can fit in all those recommended servings of fruits and vegetables every day while still reducing their total calorie intake and losing weight.  But it also means that the portions you serve yourself may be much higher in calories than the standard serving size would be.

And don’t forget that beverages have calories too!  Try to limit your intake of high calorie or sugary drinks, as well as alcoholic drinks.  They should be consumed in moderation, or not at all.  It is recommended that women limit alcoholic intake to a maximum of one drink per day (i.e. 12 fl. oz. beer, 5 fl. oz. wine, or 1.5 fl. oz. 80-proof distilled spirits).  More resources regarding a healthy diet for women can be found at http://womenshealth.gov/FitnessNutrition/eatinghealthy/.

Lastly, women over 50 may want to take calcium and vitamin D supplements. There appears to be little risk in taking them and many potential benefits, including help in maintaining weight-particularly if their diet and indoor lifestyles are causing them to have low levels of these essential nutrients.

References:

  1. The original reports of the WHI findings on low-fat diet can be found in the Journal of the American Medical Association, February 8, 2006 – Vol 295, No. 6, pages 629, 643, and 655.
  2. This report, in addition to the other reports cited in this article, can be accessed online through the Women’s Health Initiative website: http://www.nhlbi.nih.gov/whi/index.html.
  3. Dietary Guidelines for Americans [Current Guidelines – 2005 Dietary Guidelines]. (n.d.). Retrieved from USDA Center for Nutrition Policy and Promotion website: http://www.cnpp.usda.gov/DGAs2005Guidelines.htm
  4. Vitamin D [Dietary Supplement Fact Sheet]. (n.d.). Retrieved from National Institutes of Health – Office of Dietary Supplements website: http://ods.od.nih.gov/factsheets/VitaminD-QuickFacts/
  5. Calcium [Dietary Supplement Fact Sheet]. (n.d.). Retrieved from National Institutes of Health – Office of Dietary Supplements website: http://ods.od.nih.gov/factsheets/Calcium-Consumer/

Most Recalled Medical Devices Received Speedy FDA Review

Andrew Zajac, Los Angeles Times: February 15, 2011

A disproportionate number of medical devices recalled because of possible links to serious health problems or deaths — including external defibrillators and insulin infusion pumps — were approved under an abbreviated process that did not require advance testing on patients, according to a five-year study of such recalls.

More than 70% of the 113 recalled devices were cleared for market under a shorter Food and Drug Administration review because they were deemed similar to products already on the market, the study found.

Cardiovascular devices, chiefly external defibrillators, made up nearly a third of the recalled medical products from 2005 through 2009, the time covered by the review. A 2006 study linked defibrillator failure to more than 300 deaths over a 10-year period.

Only 21 of the recalls in the new study involved products approved after clinical trials. Eighty had been approved under the shorter process. Eight were exempt from FDA regulations, and four were counterfeit or categorized as “other.”

The findings, published Monday in the Archives of Internal Medicine, showed that a recent update of the FDA’s abbreviated review process, known as 510(k), was inadequate, said Diana Zuckerman, one of the study’s coauthors.

Medical device companies have stretched the notion of “similar” far beyond regulators’ intention when the law went on the books in 1976, said Zuckerman, president of the National Research Center for Women & Families. “The law has gotten looser and looser over time.”

The FDA should increase the number of devices subject to the stricter review, known as pre-market approval, or devise an intermediate category with more rigor than the 510(k) process, said Steven Nissen, a Cleveland Clinic cardiologist and a study coauthor.

The findings buttress a 2009 Government Accountability Office report that dozens of high-risk devices did not meet the legal standard for abbreviated review, Nissen said.

The FDA is evaluating high-risk products approved through its abbreviated process to see whether they should be subject to more rigorous oversight, agency spokeswoman Karen Riley said in a statement.

The study is the latest chapter in a bitter debate between device makers and public health advocates. In August, the FDA released a draft of new rules that added stricter requirements to the shorter process. […]

 

Zuckerman said she was hopeful the study would influence regulators to tighten standards.

“The process should be more stringent,” she said. “It doesn’t have to be slower.”

Read the original article here.

Device Review Process Faulted

Alicia Mundy and Jon Kamp, Wall Street Journal: February 15, 2011

Most of the medical devices recalled in recent years because of serious or life-threatening hazards were initially cleared for market through an abbreviated approval system that doesn’t require testing on patients, according to a study in the Archives of Internal Medicine.

The study by a Washington health-research group and the Cleveland Clinic’s Steven Nissen comes after the Food and Drug Administration proposed changes to tighten the faster approval system, known as 510(k), but put off some of its toughest proposals for further study under pressure from device makers.

Of 113 medical devices that were subject to recalls between 2005 and 2009, 80 were allowed on the market through the 510(k) program, the study found. About a third of the recalled devices were cardiovascular products, including several brands of external defibrillators.

“These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices,” said the authors. The lead author, Diana Zuckerman, heads the National Research Center for Women & Families, a group that has advocated stiffer approval standards for medical devices.

The 510(k) process is popular with the industry because it can save time and money in regulatory reviews, and industry lobbyists have been campaigning on Capitol Hill against radical revisions to the program.

The process requires that the proposed device be similar to a product already marketed, and is intended for low and moderate-risk devices.

The industry’s lobbying group, the Advanced Medical Technology Association, or AdvaMed, said the study is flawed because it looks at the number of recalls without comparing that to the number of devices that didn’t have problems. AdvaMed-supported studies say that more than 99% of the devices cleared through 510(k) don’t face recalls.

Overall, the 510(k) program has a “remarkable safety record with extremely low recall rates,” AdvaMed said. […]

 

A 510(k) costs the FDA an average of about $20,000 per application compared to more than $800,000 for a full device review by the agency, according to the report. A full review includes evaluation of safety-and-efficacy clinical trials. […]

Read the original article here.

 

Recalled Devices Mostly Untested, New Study Says

Barry Meier, New York Times: February 14, 2011

Most medical devices recalled in recent years by the Food and Drug Administration because they posed a high risk to patients were not rigorously studied before being cleared for sale, according to a study in a medical journal released Monday.

The study, which was posted on the Web site of The Archives of Internal Medicine, found that most medical devices that were the subject of high-risk recalls from 2005 to 2009 had been cleared through a regulatory pathway that requires little, if any, testing. The devices included external heart defibrillators, hospital infusion pumps and mechanical ventilators.

The F.D.A. described the study’s findings as unoriginal, and a trade group representing medical device makers called the research flawed. Still, the report is coming out at a time when the Obama administration appears to be stepping back from what initially appeared to be a more aggressive approach to the regulation of medical devices.

The study was written by Diana M. Zuckerman and Paul Brown, two officials from the consumer group the National Research Center for Women and Families, and Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic, who was among the first physicians to raise questions about the drug Vioxx.

In a telephone interview, Dr. Nissen said that he was concerned that the administration had failed to take a more aggressive posture toward tightening the regulation of medical devices. In recent years, thousands of patients have been injured and some have died because of failed medical devices that were cleared for sale with little testing.

“This is an area where the F.D.A. has failed the public,” Dr. Nissen said.

In a statement, the F.D.A. said that the data was not new and reflected a similar analysis that had been presented last year at a public meeting held at the Institute of Medicine. Ms. Zuckerman said she was the one who presented data at that meeting.

Recently, the agency announced a series of steps that it said would “strengthen” device regulation, though it deferred decisions on some other major proposals pending recommendations later this year from the Institute of Medicine.

The F.D.A. uses two pathways to review medical devices. In one pathway, typically used for critical, life-sustaining products like implanted heart defibrillators, manufacturers must often run clinical trials to show that a product is safe and effective.

But there is a less rigorous route, known as the 510K process, through which a manufacturer need only show that a new product is equivalent to one already on the market. Some devices implanted in the body like artificial hips and knees fall into this category, as do dozens of other products, including external defibrillators and infusion pumps.

The study focused on these 510K devices. It reported that of the 113 high-priority recalls initiated by the F.D.A. from 2005 to 2009, 80 of the recalls, or 71 percent, involved devices cleared through the 510K process.

In a statement, an industry trade group, the Advanced Medical Technology Association, described the findings as misleading. Among other things, the group said that it was not surprising that 510K devices accounted for the most recalls since most devices that F.D.A. allowed for sale went through that process.

Recalled Medical Devices Undergo Little Testing, Study Finds

John Fauber, Milwaukee Journal Sentinel: February 14, 2011

More than 80% of medical device recalls between 2005 and 2009  involved products that did not undergo a rigorous, clinical trial testing program prior to approval by the FDA, a new study found.

Among the 113 recalls of devices involving serious health problems or death, only 19% went through a pre-market approval process requiring proof of safety and effectiveness. The vast majority of the devices were approved by the FDA using a less stringent process known as 510 (k).

“The excessive use of the abbreviated approval process has allowed too many devices intended for life-preserving indications to reach the market without adequate clinical testing,” said co-author Steve Nissen.  “Unless this system is reformed promptly, we fear that public health will be jeopardized by medical device recalls for life-threatening defects.”

Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, noted that many of the recalls (31%) were cardiac devices, including automatic external defibrillators involved in hundreds of deaths.

Co-author Diana Zuckerman said the FDA is using the less-stringent 510 (k) process to approve 98% of medical devices, including heart valves, glucose meters and artificial hips and knees.

“We think patients will be shocked to learn how often new medical products, using different materials, made by a different manufacturer, are not scientifically tested in humans to see how well they work,” said Zuckerman, of the National Research Center for Women & Families. “Our study shows that as a result, many devices fail and more than 112 million products were recalled in just five years.”

The study was published in the Archives of Internal Medicine.

Study of Recalled Medical Devices Faults Lax FDA Testing Methods

Rob Stein, Washington Post: February 14, 2011

A new analysis is raising questions about how good a job the Food and Drug Administration is doing at protecting Americans from faulty medical devices.

Researchers examined the 113 devices that the FDA recalled between 2005 and 2009 for posing serious health risks, including endangering patients’ lives. Most of the devices – 71 percent – had been approved without undergoing testing in people, the researchers reported Monday in the Archives of Internal Medicine.

That’s because under a process designed to get products on the market as soon as possible, they were deemed to be similar to another product already being sold. Only 19 percent underwent more stringent review.

“Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy,” wrote Diana M. Zuckerman of the National Research Center for Women & Families in Washington, D.C., and Steven E. Nissen of the Cleveland Clinic in Cleveland.

One-third of the recalled devices were for heart disease, including automatic external defibrillators, or AEDs. Those are the gadgets that have been increasingly showing up in airports, office buildings and other public places that shock the hearts of people who suffer sudden cardiac arrest. Defective AEDs reportedly have resulted in hundreds of patient deaths, the researchers said.

The findings indicate that the agency is allowing too many medical devices onto the market using the less stringent approval process, the researchers said.

“The FDA is now using the . . . process for 98 percent of the medical devices that they review, including heart valves, glucose meters and artificial hips and knees,” Zuckerman said in a statement released with the report. “We think patients will be shocked to learn how often new medical products using different materials, made by a different manufacturers, are not scientifically tested in humans to see how well they work.”

Nissen said the findings should be a “wake-up call” to the agency and doctors.

Officials at the FDA, however, dismissed the findings, saying that it was not surprising that most of the recalls involved devices approved through the accelerated process since most of the devices on the market were approved that way.

“Even one recall is too many,” said FDA spokeswoman Karen Riley in an e-mail. “But, considering that more than 19,000 devices were cleared via the … process between 2005 and 2009, it’s important to keep the 80 recalls in perspective. They represent a small numbers of the devices cleared via this program and don’t reflect the thousands of people who have benefited from these devices.”

Riley noted that the agency had recently completed a review of the program and was making 25 changes designed to make the approval process even safer. […]

 

Read the original article here.

Report Blames Speedy FDA Clearance for Medical Device Recalls

Alan Mozes, U.S. News: February 14, 2011

Most medical devices recently recalled by the U.S. Food and Drug Administration for posing life-threatening or serious safety risks were initially approved for use by that same agency through an expedited approval process, new research reveals.

The findings call out for an overhaul of the regulatory process, to keep unsafe products from reaching the market in the first place, said the study team, led by Diana M. Zuckerman of the National Research Center for Women & Families, based in Washington D.C.

About one-third of the recalled devices were related to cardiovascular concerns, although the speedy approval process is supposedly reserved for products posing only a low or moderate safety risk, the study authors noted.

Their report is published online Feb. 14 in advance of print publication June 14 in the Archives of Internal Medicine.

“The standards used to determine whether a medical device is a high-risk or life-sustaining medical product prior to approval are clearly very different from the standards used to recall a medical device as life-threatening,” the authors noted in a journal news release. “Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either Congressional action or major changes in regulatory policy.”

The FDA, however, has already taken steps to strengthen its approval process, according to an agency spokeswoman who noted these findings are not new. […]

 

Read the original article here.

Risky Medical Devices Untested In Patients Account For Many Recalls

Richard Knox, National Public Radio: February 14, 2011

You’d think medical devices that get implanted in the body or are used to keep someone alive would have gone through studies in actual humans before being allowed on the market.

But that’s usually not the case. A study in the Archives of Internal Medicine notes that many of the most critical medical devices are allowed on the market without their makers being required to submit results of clinical studies before approval.

And, the analysis finds, most of the Food and Drug Administration’s most urgent recalls in recent years have involved “high-risk” devices that had gone to market that way.

“We found to our surprise that the vast majority of devices later recalled as high-risk and potentially deadly had never gone through clinical trials or inspections,” study author Diana Zuckerman tells Shots.

Of the 113 recalls of “high-risk” devices between 2005 and 2009, Zuckerman and her colleagues found that 80 had been approved through a process called 510(k) that doesn’t specifically require any human trials. The largest percentage of these recalls, around a third, involved cardiovascular devices such as defibrillators and stents.

And another eight of the urgently recalled devices went on the market without any FDA oversight at all, because the agency considered them to pose no risk.

The Stabilet Infant Warmer was one of devices cleared for marketing through the 510(k) process without human studies or safety  inspections, Zuckerman says.

It was marketed to “provide a controlled environment for the care and protection of infants.” In 2009, the FDA told the manufacturer to pull back 6,000 such devices under a Class I recall – the most serious kind — because the faulty device could cause serious injury or death. At least one infant was seriously injured after the device caught on fire.

The new study paid particular attention to recalls of Class III devices — those that “support or sustain human life, are of substantial importance in preventing impairment of human health, or…present a potential, unreasonable risk of illness or injury.”

By law, Class III devices are supposed to go through a process called pre-market approval that requires good clinical trials, just as the drug process does. But in the 20 years that the law has been on the books, only one percent of all medical devices has gone through this stringent process, write Dr. Rita Redberg, the journal’s editor, and Dr. Sanket Dhruva of the University of California San Francisco, in an accompanying editorial.

The reason so many devices get waved through the 510(k) process is clear enough. The FDA doesn’t have the staff or budget to do pre-market reviews on the vast majority of new devices submitted each year.

FDA charges companies a “user fee” of just over $200,000 to do a thorough review — less than a quarter of the $870,000 it costs the agency, on average, to do a pre-market approval. By contrast, pharmaceutical companies pay up to $1.4 million for pre-market approval of a drug.

The price tag for a 510(k) review: only $4,007.

The medical device industry trade group AdvaMed got out ahead of Zuckerman’s study last fall with its own evaluation of device recalls. It noted that of nearly 50,000 devices approved under the loose 510(k) process since 1998, only 77 types have been subject to Class I, or highest-risk, recalls.

“It’s hard to imagine any other regulatory process with as good a record as this,” David Nexon of AdvaMed told the Minneapolis Star-Tribune after the group released that report, which it commissioned from the Battelle Memorial Institute.

Asked how she squares her study with AdvaMed’s, Zuckerman says she agrees most devices haven’t been recalled. “But I’m taking the public health perspective,” she says. “How many people have been harmed by these products? We know that 112.6 million devices have been recalled in the last five years. That’s a lot of products. We know thousands of people have died. And those are deaths that did not have to happen.”

The backdrop to this back-and-forth is a big-deal revamping of medical device regulation that the FDA has proposed.

Zuckerman, who heads a nonprofit consumer advocacy group called the National Research Center for Women and Families, applauds some of the FDA’s proposed reforms. But she says they were watered down from the original form last summer.

Meanwhile, the Institute of Medicine is working on a comprehensive report, commissioned by the FDA, on what’s wrong with medical device regulation. That’s due later this year.