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FDA pledges better communication on drug safety: AMNews interviews Andrew von Eschenbach, MD

March 31, 2008 on 11:44 pm | In Uncategorized | Comments Off Washington -- Muscle provided by Congress last fall was intended to allow the Food and Drug Administration to police drugs already on the market. Findings from this effort could enhance physicians' understanding of a medication's potential for harm or their ability to identify patients at risk for adverse events.

Now the issue is how to get word of these findings to physicians quickly. Current methods, such as the FDA's "Dear Doctor" letters, don't always reach physicians. Figuring out which new communication approaches and technologies will work is one of the challenges the agency faces.

The FDA Amendments Act of 2007 provided more funds to monitor drugs through their life cycles as well as authority to require warnings or studies when risks are first suspected.

In the lead-up to this change, the agency's reputation as drug safety watchdog took major hits when drugs such as the pain reliever Vioxx and the diabetes drug Avandia were pulled from the market.

FDA Commissioner Andrew von Eschenbach, MD, has vowed to improve the agency's record.

AMNews: Should doctors be looking for more messages from the FDA?

Dr. von Eschenbach: We feel strongly communications need to be timely. It is something we have to look at from both sides of the equation.

We have to be careful about saturation and overload. We don't want to be Chicken Little, but we want doctors and care providers to know what we know as early as we know it and then participate in it. But we want to put it in context. We'll tell you when it is something that demands your attention and immediate action, and we'll tell you when it is something we are concerned about but are still gathering information on. And we hope you will help us with that. It will take a little time to get there.

AMNews: How will you do this?

Dr. von Eschenbach: What the FDA wants to do is collaborate and cooperate with the AMA, with nurses, with pharmacists, with the media disseminating information and with the pharmaceutical and biotech industry that also disseminates information. What we want to do is to try to get it right.

We all grew up with the Physicians' Desk Reference, which is a great tool, but in the 21st century it is not the appropriate tool. We are going to move to communications that are not paper-based but electronic-based. It won't depend on one thing, but it will depend on our ability to put in place a variety of strategies, and we will have to do it in collaboration with those who are partnering with us so they know what we know when we know it, in real time.

AMNews: Are physicians reporting their observations on drug effects to the FDA?

Dr. von Eschenbach: No. We don't have all the tools in place yet for them to do this. One of the most effective communication tools today is the Web, and the FDA is doing a complete revision of its Web site. We started a year ago revising it for consumers. It is now far more user-friendly than it was before. It is written in styles appropriate to patients and to physicians, who will have a separate entry portal.

AMNews:MedWatch is already in place. Isn't that effective?

Dr. von Eschenbach: MedWatch isn't going away. We are trying to enhance it.

AMNews:What kind of feedback will you want from physicians?

Dr. von Eschenbach: It's a spectrum. First of all, I think it's important for them to feed back to us whether the information we are providing to them -- whether it's a patient label, medication guide or a public health advisory -- is effective, useful and whether it is accessible in a way that is helping them in their practices.

We have to engage in a dialogue that respects the fact we have to make regulatory decisions about these products. We have to determine whether products should or should not be on the market and whether the way they are being utilized is being framed properly by the label. And we can't do that without physicians telling us what is happening, because they are on the front lines.

We need to ask them to share medical information and data. I know as a physician it is a burden in a very busy practice, in time, energy and effort. And I know, for many, it is a burden financially to put their practice information on an electronic medical record database. But that's what has to be done. It's not just so it's more efficient for them in office management, but so they can use and process that information in a way they can learn from the experience. And if they can share that information with us and contribute to a larger pool, we will know so much more.

AMNews: What about the solo physician in a rural practice?

Dr. von Eschenbach: They may not have the scale and scope, but they do have the experience. On a case-by-case basis, their experience may be more insightful than others' experiences. Sometimes, even in a small practice, encountering a very unusual outcome may lead to discoveries you can't even imagine.

AMNews:When you were in practice six years ago, did you find it difficult to keep up with FDA information?

Dr. von Eschenbach: It's a problem across the board for physicians trying to keep up. You go from reading every journal article, to reading every abstract, to the abstracts in your area of interest. You have to hone down.

Also a challenge was how other people are using information. Patients would come in with information they had gotten off the Web. It's not an absence of information but an abundance of information, and you need to define good information. For patients, that's confusing.

A challenge for both the AMA and the FDA is to be seen as the source of accurate and reliable information. We want the physicians and the consumer to see us as the source of the most accurate, most insightful and most complete information about medical products, drugs, biologics and devices. Because we are at the epicenter, we know more about those products than anyone else, including the person who discovered it or is making it, because we are gathering information across the spectrum.

AMNews:Does the FDA have enough money to do its job?

Dr. von Eschenbach: We've seen increases in 2007 and 2008, and we hope to see increases in 2009. But to do more, we need more. I hope the American people, through their representatives, will see this as a crucial and absolutely worthwhile investment.

Ibuprofen may lessen benefit of daily aspirin

March 31, 2008 on 11:44 pm | In Uncategorized | Comments Off Patients taking ibuprofen for pain and aspirin to reduce their chances of a second stroke may not be receiving the full benefit of their prevention efforts, according to a study in The Journal of Clinical Pharmacology in January.

Researchers assessed the combined effect of these two drugs on 10 healthy volunteers and 18 others who were using the medications for pain relief and stroke risk reduction. The blood-thinning effect of the aspirin was blunted in the healthy participants, while those who were attempting to prevent a stroke appeared to be resistant to the effects of aspirin until ibuprofen was discontinued. Also, 13 people in the latter group experienced a stroke while taking these two drugs together over a 27-month period.

"Those strokes were preventable," said Francis M. Gengo, PharmD, lead author and associate professor of pharmacy practice and neurology at University at Buffalo in New York.

Several studies have suggested that ibuprofen may interfere with the vascular benefits of aspirin. It's unclear how clinically relevant this phenomenon may be, but the Food and Drug Administration issued a statement in September 2006 calling for physicians to be aware of this interaction. The authors of this latest piece are calling for greater awareness of the possibility regarding stroke prevention.

"This interaction between aspirin and ibuprofen or prescription NSAIDs is one of the best-known but well-kept secrets in stroke medicine," said Dr. Gengo.

Physicians treating patients at high risk for a stroke or myocardial infarction responded that those taking daily aspirin should be cautioned against also taking ibuprofen regularly. This study, however, was too small to be conclusive, although it did make sense in light of findings by others who have investigated the issue.

"The only limitation is the very limited sample size, but this fits very well with previously published studies," said Tobias Kurth, MD, ScD, an epidemiologist at Brigham and Women's Hospital and assistant professor of medicine at Harvard Medical School in Boston.

Cardiologists also expressed reservations about this paper's conclusions because, although aspirin reduces the risk of stroke, it does not cut it to zero. The strokes seen during the study may have occurred with or without the use of ibuprofen.

Sweetener scrutiny: Are sugar substitutes a helpful tool or an ineffective crutch?

March 31, 2008 on 11:44 pm | In Uncategorized | Comments Off The rats in the West Lafayette, Ind., laboratory of Susan Swithers, PhD, don't lose weight when they eat artificially sweetened food. They eat more, and gain more. "Rather than these kind of products making it automatically easier to lose weight, they might make it automatically harder," said Dr. Swithers, a Purdue University associate professor of psychological sciences.

Her study documenting this phenomenon, in the February Behavioral Neuroscience, is the latest flare-up in the decades-long debate regarding the safety of artificial sweeteners and whether they aid weight loss. Cancer fears related to these products may have faded, but the theory they might trigger overeating lives on.

New evidence from some epidemiological studies supports that view. A paper in the Feb. 12 Circulation, for instance, associated drinking one can of diet soda per day with a 34% increased risk of developing metabolic syndrome compared with those who did not drink any carbonated beverages. People who drank the sugar-sweetened versions had a 10% increase in risk.

"I'm wondering if maybe the artificial sweetener makes you feel hungrier somehow," said Lyn Steffen, MPH, PhD, one of the authors and associate professor at the University of Minnesota in Minneapolis. "You drink this artificially sweetened drink, and you might feel satisfied for a short time. At the end of the day, it actually makes you eat more."

It's not clear why artificial sweeteners somehow might make weight gain more likely, but preliminary data suggest that it could be how the brain reacts. A study in the Feb. 15 Neuroimage compared the brain activity of 12 healthy women fed sugar or the artificial sweetener sucralose. Both substances activated areas of the brain associated with pleasant taste, but sugar had a stronger effect in those areas that played a role in expectation and satisfaction. The authors suggest that this finding indicates sugar may turn off the desire for more sweetness, but artificial sweeteners do not. Additional calories are needed to get it to stop.

"If you eat a pound of chocolate, you're done with it. At least for most people, your brain says, 'That's enough.' This is hypothetical and needs to be tested, but maybe the sucralose sets the sweet taste response in motion but it might not turn the brain response off," said Dr. Guido Frank, lead author on that paper and assistant professor of child and adolescent psychiatry at the University of Colorado, Denver.

Artificial sweeteners really to blame?

Despite two decades of suggestive studies like these, the theory that artificial sweeteners may lead to weight gain rather than loss has never been proven. Manufacturers and the Food and Drug Administration, which regulates the sugar substitutes as food additives, say they are safe.

"The causes of obesity are multifactorial. Although surveys have shown that there has been an increase in the use of 'sugar-free' foods over the years, portion sizes of foods have also increased, physical activity has decreased and overall calorie intake has increased," said Beth Hubrich, a registered dietician with the Calorie Control Council, a nonprofit that represents the industry.

194 million Americans consumed low-calorie or sugar-free products in 2007, up from 78 million in 1986.

And these more recent studies are hardly definitive. Critics of the rat study point out that it may not translate to humans. The number of rats, 27, was small, and the sweetener used was saccharin, which is not the most common human-consumed, noncaloric sweetener.

"They were relatively short-term studies, and there were not a lot of rats," said Keith Ayoob, EdD, director of the nutrition clinic at the children's evaluation and rehabilitation center at Albert Einstein College of Medicine, New York.

Others say the brain studies are too preliminary. The epidemiological studies, for example, don't necessarily prove that diet soda causes obesity instead of being something those who carry excess weight are more likely to choose to consume.

"It's not that drinks with zero calories cause obesity but that people who are overweight or obese are trying to do things to lower their calorie intake, including consuming low-calorie alternatives to sodas," said J. Michael Gonzalez-Campoy, MD, PhD, chief executive officer of the Minnesota Center for Obesity, Metabolism and Endocrinology in Eagan. He also is a Minority Affairs Consortium delegate to the American Medical Association and frequently speaks on obesity-related issues.

Several other studies suggest that artificial sweeteners can play a role in weight loss. Reviews such as one in the June 2007 European Journal of Clinical Nutrition concluded that humans were not that good at regulating food intake when dealing with artificial or real sweeteners.

The policy of the American Dietetic Assn. is that full and reduced-calorie products can be consumed safely. "Using [artificial sweeteners] judiciously can fit into a healthy diet," said Christine Gerbstadt, MD, a registered dietician and ADA spokeswoman.

Still, the doubt continues. Every so often, a paper seems to support this theory, and some experts suggest that persistence may have less to do with science than human nature.

"Whenever people talk about artificial, people have this strange feeling about it. Also, we're all trying to attribute blame on something. This is an easy target," said Michael Tordoff, PhD, a researcher at the Monell Chemical Senses Center in Philadelphia. He investigated this question in the late 1980s and early 1990s, and concluded that artificial sweeteners did not play a role in weight gain.

And their role in weight loss remains an open question for some physicians who advocate reducing the use of all sweeteners in favor of a more natural diet.

"I don't know if I have any science behind my recommendations, but if you asked me to recommend diet soda or water, I think every physician in the world is going to recommend water," said James Cunnar, MD, a family physician and medical director of DuPage Family Medicine in Naperville, Ill. "Personally, I have two cups of coffee every morning, and I use one teaspoon of sugar. It's a total of 30 calories, and in the grand scheme of the day, I would much rather use something more natural than a chemical to give that sweet taste."

More guidance needed

What is clear is that artificial sweeteners are very popular and that patients are unlikely to give them up. When the FDA threatened to pull saccharin from the market in the 1970s and 1980s, the backlash was significant. Gilda Radner sang songs about it on "Saturday Night Live." And according to the Calorie Control Council, that popularity of these products has not ebbed.

In 2007, 194 million Americans consumed low-calorie or sugar-free products -- a significant increase from the 78 million who did so in 1986.

Because the science is so mixed, some physicians faced with an increasingly obese population feel the need for more guidance.

For instance, Abraham Jelin, MD, a pediatric gastroenterologist in Brooklyn, N.Y., proposed at the American Academy of Pediatrics's Annual Leadership Forum last month that the organization issue a report on the appropriate use of artificial sweeteners by children. This issue now has been added to the AAP's agenda as the possible subject of a policy statement or clinical guideline.

"Kids like to have soda and sweet things, and if it's safe to give them food that's artificially sweetened, then I think we shouldn't restrict them," said Dr. Jelin, who is also vice president of his local AAP chapter as well as the head of its youth advocacy committee. "It's important that we have good studies that clearly show they're safe or show that they're not safe or they're safe in moderation."

Current AAP policy advocates limiting the intake of sweetened drinks and increasing consumption of fruits and vegetables.

"There's no official recommendation about using [artificial sweeteners] or not using them," said Ronald Kleinman, MD, chair of the pediatrics department at Massachusetts General Hospital in Boston and editor of the AAP's Pediatric Nutrition Handbook. "I tell parents I don't have any concerns about bad effects of artificial sweeteners, but at the same time, the carbonated beverages that are usually the source of artificial sweeteners are not the best things for kids to be drinking in the first place."

Many physicians also say consuming artificial sweeteners is not the only thing needed to lose weight. The real problem may be that too many patients rely on this to achieve the overarching goal. Weight-loss experts say consuming a diet soda rather than one with sugar or high fructose corn syrup is one of numerous possible choices patients can make.

"Many, many people lose weight by eating artificially sweetened foods as part of their weight-loss plan. There's years of clinical experience demonstrating that," said Mary Vernon, MD, board chair of the American Society of Bariatric Physicians and one of the authors of the Atkins Diabetes Revolution. "But we don't usually counsel people to eat unlimited quantities of artificially sweetened things."

Also, unlike rats, which subconsciously may be eating more, humans may be doing so with awareness.

"Diet soda is one of those interesting quandaries that people use to almost feel better about their other bad behaviors. People order a Double Quarter Pounder and a diet soda. How often do we all observe that happening?" Dr. Cunnar asked.

To answer the question of what role artificial sweeteners may play in weight, researchers plan to continue several lines of study. Dr. Swithers is looking for the physiological mechanisms that may link artificial sweeteners with increased food intake. Dr. Frank will investigate how artificial sweeteners affect the brain development of children and adolescents, and Dr. Steffen will dig into observational studies to determine if an association between diet soda and the development of insulin resistance and other metabolic issues emerges.

Poll Results- What do You miss the Most Since Baby?

March 28, 2008 on 10:42 pm | In Uncategorized | Comments Off

I did a poll on my facebook group “Ahhhhhhh for New Moms” http://www.facebook.com/group.php?gid=2385934019 to find out what they missed the most after baby.  The number one answer…drum roll please… was “time to self”, close behind was “sleep”, and the third most popular vote was “time with husband”.  We give up a lot when we have children, but the reward at least in my eyes, makes it all worth it.  What do you miss the most since baby?

More Veggies, Less Alcohol

March 27, 2008 on 3:49 pm | In Uncategorized | Comments Off

A new report by the World Cancer Research Fund has found that dietary changes are essential to reduce the risk of cancer.  Here are the recommendations based on the Food, Nutrition, Physical Activity and the Prevention of Cancer: A Global Perspective (2007) report.

• Be as lean as possible without becoming underweight.
• Be physically active for at least 30 minutes every day.
• Limit consumption of energy dense food (foods high in fats and/or added sugars and/or low in fiber) and avoid sugary drinks.
• Eat more of a variety of vegetables, fruits, whole grains and pulses (the edible seeds of legumes—peas, beans and lentils).
• Limit consumption of red meats (such as beef, pork and lamb) and avoid processed meats.
• If consumed at all, limit alcoholic drinks to two for men and one for women per day.
• Limit consumption of salty foods and foods processed with salt (sodium).
• Don’t use supplements to protect against cancer.
• It is best for mothers to breastfeed exclusively for up to six months and then add other liquids and foods.
• After treatment, cancer survivors should follow the recommendations for cancer prevention.
• Do not smoke or chew tobacco.