July 2010 Archives

As consumers, we made best-selling  brands out of foods and beverages that have descriptors like: "light," "diet," "low [insert noun here]." I often respond to these terms because of my desire to be healthier. These products make me feel like I'm doing what I can to cut down on hollow calories and unnecessary artificial additives.

In many cases, the "light" or "low-something" food or beverage claims to taste the same and smell the same, but, importantly, it's better for consumers than the regular product with the high carb count and  additional calories. When it comes to cigarettes however, the health benefits of a "light" cigarette are nonexistent.

Recent findings from a survey conducted by GSK show that more than one-third of smokers misunderstand the health impact of "light" or "mild" cigarettes. An equal number of smokers believe that smoking light cigarettes as a way to ultimately quit smoking is as safe--or safer--, as compared to nicotine replacement therapies.  As you likely know, nicotine replacement therapies are proven safe and effective, since their labeling and claims are regulated by the FDA. There is no scientifically recognized evidence that any type of light, low-tar, or mild cigarette is less harmful or any easier to quit than regular cigarettes.

Fortunately, one of the recent mandates of the historic legislation giving the FDA regulatory authority over tobacco has banned the use of words such as "light," "low," and "mild" on all packaging and advertising of cigarettes and smokeless products.  While some tobacco consumers will, unfortunately, still believe the years of misleading labeling and promotion of  "light" cigarettes at least there won't be any wording on the packaging to reinforce the misperception that  smokers are somehow doing a favor to their health and bodies by using these products. Those of us in the business of helping people quit smoking have won an important battle with this legislation.  However,  we haven't won the war.

To counteract, tobacco companies are using a highly-publicized marketing loophole to get around the new law - lighter colors in their packaging to indicate light or low-tar varieties of cigarettes.

Of the 66 percent of smokers in the earlier mentioned  survey considering a serious attempt to quit in the next six months, only 42 percent thought they could quit on their own. Many (40 percent) incorrectly believed they could switch to smoking a lighter-colored pack of cigarettes which would somehow make quitting easier.

As research and experience continues to prove, the best way to quit, is to stop smoking completely  using proven tools like nicotine replacement therapy and behavioral support programs. GSK will continue to help smokers realize that it's time to skip the "light" middle man and quit for good.

Today's inflammatory New York Times story, "Diabetes Drug Maker Hid Test Data on Risks, Files Indicate," is based on selected documents provided to plaintiffs' attorneys in litigation which were then also provided to the Senate Finance Committee.  Selectively making public a cherry-picked few documents from over 14 million pages in litigation presents an incomplete and misleading picture of the safety of Avandia and company conduct.

The New York Times focuses on one small study that did not involve Avandia.  GSK conducted this study on a competitor drug looking at its effects on LDL cholesterol and triglycerides; it was not a head-to-head study directly comparing Avandia and the competitor, pioglitazone, as reported by the New York Times.  GSK conducted the study to help inform a decision of whether or not to do a head-to-head trial between Avandia and the competitor.  The results of this competitor drug study were consistent with the FDA-approved drug label for pioglitazone, and therefore did not contribute any clinically significant new information.  Because the study offered no new clinically relevant information and did not involve a GSK drug, GSK did not publish the data. 

Two studies comparing Avandia and another drug, glyburide, are referenced by the New York Times; it's important to note that GSK submitted this data to the FDA in 1999 and made those data available publicly on the company's Clinical Study Register.

GSK has worked consistently--before and after Avandia was approved in 1999 by the FDA--to add to our understanding of the cardiovascular safety of the medicine.  As far back as late 2001, as part of the company's ongoing pharmacovigilance program, GSK conducted a review of Avandia and heart attack.  At that time, the data identified no signal of an increased risk for heart attacks associated with Avandia.  GSK informed the FDA of this internal review and described its results in a Periodic Safety Update Report. 

Subsequently and to date, over 200 studies and protocols on Avandia--including those that contain data on heart attack--have been made publicly available on the company's clinical trial register.  In fact, Avandia is the most widely studied oral anti-diabetic medicine for type 2 diabetes, which means we know more about both the safety and the efficacy of this medicine than any other oral drug for diabetes.  When you look at all of the clinical trial data available, we believe the data show that Avandia has an ischemic cardiovascular safety profile comparable to the most widely prescribed oral diabetes medicines.  GSK has been--and remains--committed to and diligent in providing its safety data on Avandia to the FDA, and in publishing its clinical trial data in peer-reviewed journals or on its clinical trial website.

Here is our statement on the Senate Finance Committee press release issued today.

And here is our legally required fair balance.

Important Safety Information

AVANDIA can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart) you cannot be started on AVANDIA. AVANDIA is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling) even if these symptoms are not severe.

AVANDIA may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin.

If you have chest pain or a feeling of chest pressure, you should seek immediate medical attention, regardless of what diabetes medicines you are taking. If you take AVANDIA, tell your doctor right away if you: have swollen legs or ankles, a rapid increase in weight or difficulty breathing, or unusual tiredness; experience changes in vision; become pregnant.

Before taking AVANDIA, review your medical history and tell your doctor if you:

• Have heart failure or other heart problems, or are on any medicines for high blood pressure, high cholesterol or heart failure, or for prevention of heart disease or stroke.

• Take insulin or nitrate medicines.

• Have a type of diabetic eye disease called macular edema.

• Have liver problems or had liver problems while taking REZULIN® (troglitazone).

• Are pregnant or planning to become pregnant.

• Are breastfeeding or planning to breastfeed.

Women taking AVANDIA should know that AVANDIA may increase the risk of pregnancy. More fractures have been observed in women taking AVANDIA. Other possible side effects of AVANDIA include anemia and hypoglycemia. Your doctor should do blood tests to check your liver before you start AVANDIA and during treatment as needed.

Prescription AVANDIA, along with diet and exercise, helps improve blood sugar control in adults with type 2 diabetes.

For more information about AVANDIA, please see Medication Guide

(http://www.avandia.com/type-2-diabetes-medication-guide.html) and full Prescribing Information, including Boxed WARNING (http://us.gsk.com/products/assets/us_avandia.pdf).

During some of my vacations I have volunteered with a group of physicians to set up free clinics in places like rural India and Malaysia. The people I saw there often had to walk miles to the nearest hospital and therefore couldn't easily access healthcare. We educated parents about the importance of vaccinating their children, recognizing symptoms of the disease (severe diarrhea, vomiting and fever that lead to dehydration), and the urgency of taking their child to the hospital if they suspect rotavirus infection. We also addressed misconceptions about caring for infected children. For example, some mothers stop breastfeeding since their babies have a hard time keeping food down, but it is crucial to continue feeding to keep the child hydrated. We also distributed and educated on the use of oral rehydration solution which is critical in helping address dehydration.  There is still a lot of work to be done in developing countries, but efforts like these help increase understanding of the disease, which is a key first step.

In developing countries, severe dehydration caused by rotavirus disease can frequently lead to death.  In the U.S., access to hospitals greatly reduces this risk, and it is rare that children in the US die from rotavirus disease.  However, rotavirus is not a passing infection; it can be severe and may cause diarrhea and vomiting and other symptoms that continue for a week to 10 days. Before rotavirus vaccines were available in the U.S., an estimated 2.7 million children younger than five years of age got rotavirus disease every year. Since 2005 Rotavirus immunization has been one of the routine, recommended vaccines. Vaccination has significantly reduced incidence of the disease and related hospitalizations.

In addition to my professional work, I have had personal experience with Rotavirus illness as a parent. When my kids were babies, rotavirus vaccines were not yet available. My son was infected with rotavirus when he was a little over a year old. It was distressing to be unable to do anything other than treat his symptoms and give supportive care by keeping him hydrated. 

As a parent and a physician, I think it is important what we all understand the burden of Rotavirus disease and the role vaccines play in prevention.

Born and raised in Philadelphia, I'm always happy to see the City doing something positive when it comes to health initiatives and fighting its obesity issues.  This week, the Philadelphia Inquirer highlighted the outcomes in a national health study in which six Philadelphia schools implemented changes in the physical education programs as well as lunch menus, even going so far as to limit beverage options to water only.  See the full article on the New Enjoy Journal of Medicine's website. 

Clearly the city has much work to do, as it is ranked the 20^th fattest city according to Men's Health (right behind Raleigh, by the way).  Regardless, the City is taking steps and addressing the issue and with the stimulus funds it has received important programs such as the Healthy Corner Stores Initiative which works to get fresh fruits and vegetables into corner stores, will get the funding they need to be successful.

It's a good start, let's keep it up.