Archive for May, 2007

The Truth Of The Avandia Scare…

May 31, 2007

imagestel.jpgMy phone never stopped ringing …literally!  Apparently the NEJM publication caught the media in a frenzy mood!  The headline noting the increased risk of heart attack with the use of Avandia brought about the public scare and the panic.   This is one case to point where everything written in a well respected journal should be studied, scrutinized and reviewed before offering to the media to be sensationalized!

The real inside story however was never told as to why there was a need to rush the publication coupled with a sensationalized editorial.  Below is The  Wall Street Journal Commentary which I want to share with the readers and my patients as well…. 

As medical information is exploding and becoming more accessible, all of us, particularly physicians, need objective sources to interpret data and present a balanced view. Unfortunately, major medical journals that should be filling this role often put more weight on pushing political agendas.

Their editorial prejudice has left a troubling void for rigorous and unbiased arbiters of medical evidence who can guide sound medical practice decisions.  The behavior of the New England Journal of Medicine (NEJM) is a case in   point, when it rushed onto its Web site a limited and flawed analysis of safety concerns around the diabetes drug Avandia. The publication was timed to get ahead of the Food and Drug Administration’s more careful evaluation of the same issues. The journal seemed bent on beating the FDA to the punch. The goal? Painting the FDA as impotent, in order to argue for legislation winding through Congress that would increase regulatory hurdles for drug approvals. The journal’s motives were made bare by its own editorial on the matter.    

While there are “questions” whether Avandia is associated with certain heart risks — so far unsupported by more rigorous, randomized studies   and  extensive review by the FDA and other authorities around the world — the NEJM study doesn’t add much new insight into those issues because of its own limitations.   But you wouldn’t know that from the way the Journal hyped its analysis to the media or opined about the study’s significance. These facts weren’t lost on clinicians and even NEJMs competitors. The Lancet,  NEJM’s British sister-publication, said of the study, “Alarmist headlines and confident declarations help nobody.” A top American medical researcher  told WebMD, “I can’t help but wonder if the NEJM is functioning more like the mainstream press than a scientific journal at this point.”
      
 The paper which re-analyzed the results of 42 earlier studies of the drug found on the Internet, revealed that Avandia might cause a small increase in the absolute risk of a heart attack. But the study that the authors did, called a”meta-analysis” because it aggregates results from lots of studies to generate a larger sample, contained a number of serious limitations.
 

Among other things, the authors of the NEJM study based their conclusions that Avandia caused a higher heart risk on just a handful of cardiac events, none of which they could go back and verify, because, unlike the  FDA, the authors didn’t have access to confidential patient records

Dr Goetlleib who wrote the commentary further noted that….Absent was any discussion by NEJM of the drug’s benefits, or advice  from  diabetes experts on how doctors should counsel their patients based on the  information.

So Better Be informed Before We Judge!

Advertisements

Do You Need To Stop AVANDIA?

May 28, 2007

images.jpgMy email alerted me on this headline regarding the alarming news on a most commonly prescribed drug for diabetes called rosiglitazone or Avandia manufactured by GSK and the apparent increased risk of heart attack among those taking the drug! 

The problem is: New England Journal of Medicine article was only a meta-analysis of different articles that studied the drug but not with cardiovascular diseases as a primary endpoin.  The RECORD trial which will be available in 2009 is the ONE that we have to wait to fully answer the question of avandia and the risk of heart disease.

The comments of different societies complement my thoughts of the safety of this drug…meaning for me…the benefits continue to outweigh the risks.  I am a prescriber of this drug because it really helps my patients get into control, lower the rquirements for insulin with beneficial effects in protecting and preserving beta cells and therefore delays the progression of the disease.  This for me is important if we want to prevent long term complications.

1. Lancet‘s response to the NEJM article (23rd May) entitled “Rosiglitazone: seeking a balanced perspective.”

The editorial
criticises the NEJM publication
– states that the’ two most reliable studies to inform decision-making’ currently available are ADOPT and DREAM
– acknowledges that, although the recent NEJM meta-analysis (based on a small no of events) raise a signal of concern, before the results of RECORD are available it would be premature to overinterpret a meta-analysis

The editorial concludes by saying

To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of rosiglitazone is needed. Alarmist headlines and confident declarations help nobody

2.The European Medical Association (US FDA counterpart in EU) recommends that, in EU markets, ‘patients are advised not to stop treatment with rosiglitazone and to discuss the medication with their doctor at their next regular visit’. societies:

Statement from US organisations
http://diabetes.org/diabetesnewsarticle.jsp?storyId=15115339&filename=20070521/comtex20070521pr00004113diabetesavandiariskEDIT.xml

Statement from Canadian Diabetes Association
http://www.diabetes.ca/section_main/newsreleases.asp?ID=194

Statement from Diabetes Australia
http://www.diabetesaustralia.com.au/notice_board/mediacentre.htm#NEJM

Statement from Diabetes UK
http://www.diabetes.org.uk/About_us/News_Landing_Page/Rosiglitazone-heart-attack-risk-not-cause-for-alarm/

Lastly, a fellow blogger Kevin MD had his thoughts on this and pointed out Dr Steven Haffners comments in his post:

Dr Steven Haffner (University of Texas Health Science Center, San Antonio), who was involved in the ADOPT study of rosiglitazone, said the paper needed to be published, but it should have undergone a more extensive review, and there should have been a different editorial with more emphasis on the flaws of the study. “The NEJM was irresponsible to go to [Drs Bruce] Psaty and [Curt] Furberg for the editorial–they were always going to emphasize concerns about drug safety; that’s what they do,” he commented. “But I’m not surprised this paper was published like this. The three major medical journals are becoming more like British tabloid newspapers–all they lack is a bare-chested woman on page 3,” he jibed.

For me….I will continue to believe in this drug as one helpful arm in my quest for a better treatment regimen for my patients with diabetes. The NEJM article is not the perfect study we look for to answer the questions of safety.  A Meta-analysis has its flaws which will be corrected by future proscpective studies with cardiovascular disease as a primary endpoint.

If you have your doubts… talk to your doctor.

If you believe in the drug and your doctor asked you to stop it based on NEJM article and its editorial …talk to a Specialist!

The Editorial of the well respected Lancet says it all:

Alarmist Headlines and Confident Declarations Help Nobody

Knowing Your BMI Means Taking Action To Be Healthy….

May 23, 2007

ca_fatheart_car.gif

This is an important chart for everyone to keep just to trace where our BMI is going! Up or Down! 

The International Obesity Task Force also came up with standards to follow for the Asia Pacific Region which calculates a lower BMI for the Asian population as overweight and obese

Why do we need to know our BMI? Because it calculates your health risk.  And more importantly, this tracks your progress in losing weight and therefore for every one point drop in BMI translates to a concomitant reduction for its associated disease risk especially early mortality….  Studies have shown that: if you’re obese your risk to die early is high! 

Remember…

Knowing the Numbers Means Wellness…

Read My Other Related Posts:

The Health Benefits of Visiting The Beach….

May 21, 2007

boracay-at-night.jpgWe all heard of Boracay… we all heard of the pleasures of going to a beach, enjoy the breath of fresh air, the crystal clear waters, the white sands and the fun!  Indeed… these things are true with Boracay.  Ive been to different resorts and I agree that nothing beats the beach of Boracay!  Except probably for El Nido in Palawan, the beauty of Boracay stems not only from the white sand beach but more so… the people, the view, the sunset and whole of what the place brings…

another-castle.jpgNo pollution, no factories, no litter ( or else you’re fined) and literally you feel so safe strolling down the stretch of white sand beach up to dusk!  People know that tourists are their means of livelihood so everybody tries to protect them from getting harmed! You just feel so relaxed and so free from all the hassles of everyday life in the city.  For me, this brings to what we doctors always recommend to our patients to explore a a stress free environment especially to people who have no time to sleep, think a while about themselves and their families and just take time to sit down, enjoy the view, the sun and have fun!  This whole experience can really rejuvenate oneself and help boost one’s immune system to help help fight long term chronic diseases like cancer, depression and infections.

I however recommend to visit the place in times where there are not much crowd.  If you want to explore Boracayand enjoy the benefits of what relaxation can bring, then avoid going there in December or in April.

sunset.jpgMy visit to Boracay this weekend was perfect.  Not only was I able to share some tips on how to manage Diabetes to fellow doctors coming from Bacolod and Iloilo but also had time to explore the place and relax with my family who enjoyed every minute of the experience.  I enjoy teaching so I welcome sharing what I know to fellow doctors all over the country because not only am I able to live my advocacy of sharing my expertise in the field of endocrinology but also the chance to visit places in our country far better than in other parts of the world! ( Click on the pictures that I took during my visit to see how beautiful this place is.)

Lastly…Dont ever miss the beautiful SUNSET of Boracay!  It’s worth the visit and time!  Truly this place can work wonders to help us feel better and healthier!

A Breath of Fresh Air Is Worth A Thousand Cure!

New Guidelines for Obesity

May 18, 2007

2504513455.jpgObesity is becoming a pandemic.  Worldwide, different health institutions are trying to formulate plans to hopefully and successfully combat this problem.  I often ask my patients to check the degree of obesity becoming a reality in our surroundings.  Since it’s summer, if you go to a pool or a beach, check the number of children you see as obese and you”ll really come to realize the increasing prevalence in our local setting.  I thought of this as a screening test for the growing number of obese people…because I’ll definitely do this thing when my family will enjoy the beach of Boracay this weekend! Nope I’ll not be doing this because I have other plans for my eyes to feast on ….

Recently, published in the April 10 issue of the Canadian Medical Association Journal is the fhe first-ever Canadian Clinical Practice Guidelines (CPG) on the Management and Prevention of Obesity in Adults and Children.   The group specifically recommends that waist circumference be measured along with height and weight.  Furthermore the guidelines also recommend that:

* First-line treatment for overweight and obese adults should consist of diet changes and regular exercise, supported by behaviour change; if unsuccessful, treatment with medications or bariatric surgery should be considered;

* Starting at 10 years of age, overweight or obese Canadians should undergo screening that would include tests measuring levels of fasting glucose, HDL (the good) and LDL (the bad) cholesterol, and triglycerides (a form of fat in the blood) levels. Furthermore, they should be monitored at regular intervals;

* Patients participating in weight management programs should be provided with education and support in behaviour modification techniques as an add-on to other lifestyle modifications;

* Programs to promote healthy, active living and to prevent overweight and obesity should be implemented in schools to reduce the risk of childhood obesity; these include interventions to increase daily physical activity through physical education class-time and opportunities for active recreation;

* “Screen time” (e.g. television watching, and video or computer games) should be limited to less than two hours per day to encourage increased activity and less food consumption, and to limit exposure to food advertising.

We all know them to exist.  I have written about them in previous posts.  But the problem is the implementation of the guidelines.  Unless our government helps in implementing them, and more marketing strategies by private and public entities that promote healthy lifestyle, these guidelines will remain as guidelines meant to inform and never practiced!

The American Association of Clinical Endocrinologists, Philippine Chapter of which I am a Board Member will definitely make this thrust an active part of our advocacy in promoting healthy lifestyle among the school children.  So watch out for us in some private schools nationwide as we will really be actively involved in this Fight!  For those interested, please contact me through this post and inform me of your interest for the group to make your school be part of this program.

Be Involved … Be Our Partners in Our Fight Against Obesity! 

Can Fruits Cause Obesity?

May 15, 2007

imagesfrd1.jpgWe love fruits.  Being a natural source of sugar, we believe it is harmless in most ways. In fact you may have heard friends who tell you that they lose weight because they are on a fruit diet!  But too much of a good thing can turn out bad especially if over-consumption becomes a habit rather than an exception.

Recently though, the notion that fruits is generally okay has been challenge especially in the field of obesity.  Apparently, in animal studies, researchers from the University of Florida have found that fructose tricks your brain into thinking that you are hungrier than you truly are, causing you to eat more to feel satiated. The pathway at which fructose may be responsible for the rising epidemic of obesity is published in Nature Clinical Practice: Nephrology.

While it is common knowledge that the common causes of obesity includes the intake of high-fat, high-calorie foods and forgoing exercise, the concept of fructose as one culprit has never been on top of the list to determine if this sugar is in fact an underlying cause of metabolic syndrome, a condition that is linked to type 2 diabetes and obesity.

Fructose is present in many foods that we eat including the high fructose corn syrup to soft drinks, the jellies our children love , the pastries,  the tomato or banana ketchup and other commonly used products.  It is estimated that fructose consumption has risen more than 30 percent since the 1970s which coincided with the rise in the rate of metabolic syndrome and obesity worldwide.

But can fruits cause obesity? No link of that yet but again… eating a balanced meal with a fruit serving per meal should not make one gain weight MORE than the benefits of fruit consumption you’ll get!  But the general rule on fruits is: The Sweeter…The More Fructose…The More Calories!One Fruit Per Meal Is The Deal!

How Much Caffeine is In Our Drinks?

May 10, 2007

2333326284.jpgWe know caffeine is a stimulant.  Therefore we tend to grab a cup of coffee everytime we feel we need a jolt out of our daily routine resulting in exhaustion or just mere tiredness.  But researchers have warned us about too much caffeine because of its health dangers including the effect of caffeine on the heart and bones as well as our ability to take a good sleep.  Likewise studies have shown too much caffeine can lead to stomach problems like ulcer or esophagitis.  People who likewise drink Energy drinks should also be cautioned because all they contain are sugars and caffeine.

Students trying to cram for an exam should be warned of the palpitations and jitteriness that they will feel if their body is loaded with caffeine.  On the other hand, those wanting to have a good sleep or the insomniacs should limit caffeine during the 4 to 6 hours before bedtime.  It is estimated that approximately 50% of the caffeine consumed at 7 PM remains in the body at 11 PM…the time frame that we want to go to bed!

One may actually be avoiding coffee per se to avoid problems with sleeping but remember that caffeine can be present in many different foods, beverages and medications.

Coffee (5 oz. cup)
Brewed, drip method 60 – 180 mg caffeine
Instant 30 – 120 mg caffeine
Decaffeinated 1 – 5 mg caffeine
Tea (5 oz. cup)
Brewed 60 – 180 mg caffeine
Instant 25 – 50 mg caffeine
Iced (12 oz. Cup) 67 – 76 mg caffeine
Chocolate
dark/semisweet 1 oz. – 5 – 35 mg caffeine
Soft drinks
cola (12 oz.) 36 – 47 mg caffeine
Non-prescription drugs
Dexatrim 200 mg caffeine
No Doz 100 mg caffeine
Excedrin 65 mg caffeine

But drinking coffee per se has many health benefits including the possibility of preventing diabetes and liver and other ailments as well as help us lose weight.  And therefore…Just as always…we recommend drinking or taking anything or even doing things in Moderation is the key to prevent dangers because…

Too Much Of A Godd Thing Can Turn Out BAD!

Read My Other Related Posts:

The DANGER of Taking Antioxidants…BEWARE!

May 8, 2007

23349167291.jpgScience is ever-changing. One study should not make one take a pill just because it shows the drug to be beneficial. Any research should be carefully done and reviewed and if published in a reputable peer reviewed journal then its worth a second look!

The story about antioxidants and their benefits is one controversy. You may have heard a lot already about the benefits and side effects of Vitamins E and C but what is really the real score?  So before grabbing these vitamins… take to consider the facts below: 

The results of this study came from a meta-analysis of 68 randomized trials with a total of 232,606 patients published in the February 28 issue of JAMA.

  • Vitamin C does not appear to be detrimental but it is not beneficial either.  It likewise did not decrease or increase  mortality.
  • Trials of selenium showed it to be neither of benefit nor harm.

But the most striking results that I want readers to take note is that:

…. Vitamins A and E actually increased the risk for mortality whether it is used alone or in combination….

These data only point to one thing:

…That people should NOT take these over the counter supplements marketed as anti-oxidant vitamins in an effort to prevent illness…because…THEY DON’T!

…And as the usual cliche… we should instead” eat a balanced diet and take regular exercise“… as full proof to healthy living with NO SHORTCUTS…because…

Being Healthy Requires No Shortcuts!

Tips To Eat Less

May 4, 2007

imagesl.jpgThe main obstacle in losing weight is FOOD. The availability of tasty high caloric foods  in a glance within minutes within our sight anytime and anywhere tempts us to eat, savor the taste and enjoy! That’s how man was born to live! To work hard and enjoy the fruits of ones labor by eating a satisfying meal after a hard days work.  Unfortunately… we enjoy the food so much and its overabundance has lead to a lot of suffering instead! 

BUT…by eating well and balancing the kinds of food and taking time to consider what to eat and how much during each meal should make a difference long term. 

I found this interesting  article on tips on how to eat small from the April issue of the Mayo Clinic Health Letter which I want to share: 

  • Select smaller bowls, plates and spoons for serving and eating. Research has shown that people eat more when food is served in or eaten from larger dishes.
  • Get rid of high-calorie leftovers; store them in inconvenient locations or in opaque containers. — Seeing a calorie-laden goody can trigger the desire to eat. Food in the basement pantry is less tempting than leftovers on the kitchen counter. Weight loss is easier when healthy, low-calorie foods are within sight and easy reach.
  • Buy small packages and serve or order small quantities. Larger packages or larger portions often lead people to eat more than they would if the serving or package were smaller. After serving appropriate portions, put leftovers away immediately or, at a minimum, keep the serving dishes off the dining table.

Actually, we know these tips exist but constant reminder may help us follow these tips if we are really serious in our quest for…

Better Health Through Healthy Weight!

Are Eggs Healthy To Eat?

May 2, 2007

4069335754.jpgI just received a comment from Nick regarding my post on ” Can I Eat Eggs Everyday” (My most popular post!) and I guess based on the many comments I received, we continue to have mixed beliefs on whether to eat eggs daily or its unsafe to do so because of the risk of heart disease.

So far, I agree with Nick that not a lot of prospective studies have been done to look at eggs per se and heart disease but rather its the relationship between the amount of saturated fat and cholesterol and heart disease that we all know exists.

Here’s a timely article from the Harvard Medical Letter  on the Myths and Facts of Egg Nutrition and Health:

Fact: Eggs are a good source of nutrients. One egg contains 6 grams of protein and some healthful unsaturated fats. Eggs are also a good source of choline, which has been linked with preserving memory, and lutein and zeaxanthin, which may protect against vision loss.

Fact: Eggs have a lot of cholesterol. The average large egg contains 212 milligrams of cholesterol. As foods go, that’s quite a bit, rivaled only by single servings of liver, shrimp, and duck meat.

Myth: All that cholesterol goes straight to your bloodstream and then into your arteries. Not so. For most people, only a small amount of the cholesterol in food passes into the blood. Saturated and trans fats have much bigger effects on blood cholesterol levels.

Myth: Eating eggs is bad for your heart. The only large study to look at the impact of egg consumption on heart disease—not on cholesterol levels or other intermediaries—found no connection between the two.

In people with diabetes, though, egg-a-day eaters were a bit more likely to have developed heart disease than those who rarely ate eggs.If you like eggs, eating one a day should be okay, especially if you cut back on saturated and trans fats. Other ways to enjoy eggs without worrying about cholesterol include not eating the yolk, which contains all the cholesterol, or using pourable egg whites or yolk-free egg substitutes.

There you go: if you want to eat eggs daily: cut back on other sources of fat. It’s the yolk that’s rich in cholestrol so use it sparingly and instead enjoy the egg whites!

The Controversy Continues…..

Read My Other Related Posts: