Recently in Safety Category

Some time ago, our CEO, Andrew Witty, issued an innovation challenge to IT: find new ways that technology can help the business. Our IT team started doing research on how to reach doctors in developing worlds, where the geography is vast, through the internet and mobile devices. We kept coming across news unrelated to our project--devastating news about counterfeit medicines and the harm they bring patients.

Counterfeit medicines are a big problem in Africa; an estimated 10-30% of the products sold are counterfeit. The counterfeit products, often sold in open markets, vary from toothpaste to medications for life-threatening conditions. There's no way to know what is real and what is fake.

Last summer, I read an interesting article about mobile phone use and technology in Africa. A man from Ghana had started a small start-up company in the US using SMS texting to protect consumers from counterfeit products.  My team and I called the company to learn more, and we liked what we heard.

We talked to the General Manager in Nigeria and then made the connections between the various GSK groups in Nigeria, Manufacturing, IT and Corporate.  Manufacturing, as it turns out, was already doing a serialization project to assign individual numerical identifiers to products. We decided to launch a pilot in Nigeria.

The way it works is simple. Every package of our antibiotic (1.7 million units in all) has a unique, scratch-off code. Consumers send the code via a SMS text message to a central, toll-free phone number for verification. The mobile service looks up the code and sends a verification text back to the consumer. Consumers can also call a toll-free phone number if they have any questions.

In February 2011, when the codes began to appear on the packaging, consumers immediately began to text. The initial numbers were so high, reaching 1,000 texts per day within the first few weeks, we almost didn't believe them. This month, GSK and the Nigerian regulatory agency will launch an awareness campaign, and we expect the numbers to climb.  If the pilot shows continued success, we'll plan to expand the program to other products and other countries.

Consumers now have the power to detect fake drugs. That's an innovation we can all be proud of.

On August 20, we blogged about our July 28 communications with clinical trial investigators in TIDE, a prospective, cardiovascular outcome study comparing Avandia  (rosiglitazone) to Actos  (pioglitazone) as mandated by the U.S. Food and Drug Administration (FDA).  That July 28 communication summarized the two-day FDA Advisory Committee meeting (July 13-14) on the cardiovascular safety of Avandia. There is an update from FDA regarding the TIDE trial which we felt should be shared for the sake of transparency.

Since the post was published, GSK has received a request from the FDA that the company inform the TIDE Steering Committee to "re-issue a letter"  for trial participants that was sent prior to GSK's July 28, 2010 summary for investigators, Institutional Review Boards and Ethics Commitees  involved in the TIDE trial. 

The FDA wrote GSK that the July 16 letter to trial participants did "not accurately capture the results on all the voting questions posed to the advisory committee panel at this meeting. There is an overemphasis on the mortality findings that appears to dismiss the risk of ischemic cardiovascular events, particularly between rosiglitazone and pioglitazone.  Consequently, this information does not fully inform participants of the potential risks of the different treatments in the TIDE trial."

GSK is complying with this recent FDA request.

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).

There has been continued focus today in the healthcare news media, on health blogs and Twitter on the US Senate Finance Committee's report regarding GSK and our diabetes medicine Avandia.   Patients, doctors, media and others are asking questions about our company and the safety of our medicine.  Looking at a lot of the content and commentary, it is clear that many people are only getting part of the story--or worse, the wrong message entirely.

In particular, misleading headlines stating that "FDA Report Advises Avandia be Pulled from the Market," were re-Tweeted dozens of times; other commentary we found to be more balanced including this piece in Forbes gained less attention.   According to their own statement this afternoon, "FDA is now reviewing the primary data from the completed RECORD study, conducting follow-up audits, and reviewing additional studies. This work is ongoing and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time."  FDA further advised doctors:

When prescribing rosiglitazone, healthcare professionals should follow the recommendations in the drug label. Patients should continue taking rosiglitazone unless told by their healthcare professional to stop. Patients who are concerned about the possible risks associated with using rosiglitazone should talk to their healthcare professional.

FDA has called for a public advisory panel meeting this July and we look forward to working with FDA and the panel to provide any further information they request.

In addition to the FDA's advice patients and their doctors may be interested in the perspective of organizations including the Endocrine Society and the American Heart Association. 

We will continue to post new information and clarifications regarding this issue as we believe necessary, but hope to get back to using this space to focus on "More than Medicine."

We issued a statement strongly challenging the characterization of our medicine and our company.  And while it remains our pledge not to promote GSK products on this blog, we do want to address the accusation that our company has somehow acted inappropriately, and worse, endangered patients' health.  We also want to provide some important information that media reports do not include.

First, let's address this idea that the FDA is calling for withdrawal of Avandia.

The FDA itself has not issued new data or called for withdrawal. Instead, the document referenced in the media is a report from 2008 by two doctors who work at the FDA, resurrecting a call they made the year before--employing statistics they used at that  time (e.g. 83,000 excess heart attacks between 1999 and 2007)--to say that Avandia has harmed patients. But importantly, these same claims and the call for withdrawal were considered--with all the scientific data available at that time--by an independent panel of scientific experts in 2007.  That independent panel voted 22-1 to recommend that Avandia remain available to patients for the treatment of Type 2 diabetes.  The FDA considered this recommendation and also decided, based on its own review of the science, that Avandia remain available to patients for the treatment of Type 2 diabetes. In the years since the FDA made its decision to keep Avandia on the market, seven clinical studies do not show an increased risk.

If we talk numbers, we need to talk about those clinical trials. Those seven large, prospective, randomized, clinical trials have completed and reported data on the cardiovascular safety of Avandia.  These types of scientific trials are the gold standard for gathering and evaluating scientific data.  None of these randomized clinical trials showed a statistically significant association between Avandia and heart attack or other ischemic cardiovascular events, like angina.

Second, let's address the idea that GSK did not share information the company had about the medicine's safety. 

Again, we disagree with that assertion.  Any fair examination of the company's record will show that GSK has been transparent in its efforts to thoroughly study the safety and effectiveness of Avandia, and to widely communicate that information to governments, regulatory authorities, scientific peers, physicians and others in a variety of ways. 

At the time Avandia was approved by the FDA to be used along with diet and exercise by type 2 diabetes patients, GSK and regulatory agencies agreed it was important to develop the highest level of scientific evidence to assess the medicine's benefit-to-risk profile for type 2 diabetes, a chronic disease. Accordingly, GSK has followed a rigorous program of scientific analysis to research both the safety and benefits of Avandia. GSK promptly started the clinical studies it promised the FDA it would do.

GSK has reported its study findings to regulatory agencies, including the FDA, based on emerging clinical trial results and other data regarding the safety profile of Avandia. GSK gave its meta-analyses to the FDA and posted them on its web.  Dr. Nissen, however, told Congress at the June 6, 2007 hearing that he gave his analysis to members of Congress rather than the FDA.

GSK also made studies and other data regarding Avandia available to scientists in the public domain in a variety of ways, including publication and posting data on the company's Clinical Trial Register. Dr. Nissen gathered data for his analysis from GSK's Clinical Trial Register, so the GSK data was obviously available publicly.

In addition, GSK has updated the product information for Avandia over the years to add cardiovascular and other safety information as new data has become available.

Third, let's address the idea that GSK intimidates scientists to squelch scientific debate.

GSK welcomes and supports open and independent scientific debate about its medicines.  GSK does not condone any effort to silence such debate.  As part of the process of scientific debate about medicines, we engage with scientists and physicians around the world in many forums, including academic journals, scientific and medical conventions, and other meetings. 

Occasionally, GSK believes that statements made by others are not fully accurate or don't correctly present information on our medicines.  For example, one Continuing Medical Education presentation contained inaccuracies about data on Avandia soon after the medicine became available to patients. GSK believed it was very important to seek a correction to ensure that the data on Avandia were accurately presented to physicians.  In such situations, it's appropriate for the company to address and try to correct such inaccuracies or misstatements--in fact, we have a responsibility to do that so physicians have the most accurate information available to make the best choice of medicine for their patients.

The health and safety of patients who rely on our medicines is our priority.  Our concern is that inaccuracies in the media will fuel fear and scare diabetic patients into stopping their medicines, with potentially serious health consequences.  GSK stands by the safety and efficacy of Avandia when used appropriately according to its labeling and maintains this is an important medicine for the treatment of Type 2 diabetes. 

Important Safety Information about AVANDIA^® (rosiglitazone maleate)

Prescription AVANDIA, along with diet and exercise, helps improve blood sugar control in adults with type 2 diabetes. Taking AVANDIA with insulin or nitrates is not recommended.

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.

For more information about AVANDIA, please see Medication Guide. For further information on AVANDIA, please see full Prescribing Information.

Today GSK alerted consumers to a potential health risk from long-term excessive use of zinc-containing denture adhesives Super Poligrip 'Original', 'Ultra Fresh' and 'Extra Care'.

While zinc is an essential part of the diet, recent publications suggest that an excessive intake of zinc-containing denture adhesives over several years may lead to the development of neurological symptoms and blood problems such as anemia. Neurological symptoms may include numbness, tingling or weakness in the arms and legs and difficulties with walking and balance.

Super Poligrip is safe to use as directed in the product label. The majority of consumers follow these directions. However, some consumers apply more adhesive than directed and use it more than once per day. Therefore, as a precautionary measure to minimize any potential risks to these consumers, GSK has voluntarily stopped the manufacture, distribution and advertising of these products.  GSK has discussed this situation with the FDA and no further action is required.

What consumers should do

If you have been using zinc-containing Super Poligrip 'Original', 'Ultra Fresh' or 'Extra Care' for several years in greater amounts than directed on the package or more than once per day, or have concerns about your health, you must:

1.     Stop using the product.

2.     Talk to your doctor.

3.     Use a zinc-free alternative such as Super Poligrip 'Free,' Super Poligrip 'Comfort Seal Strips', or Super Poligrip 'Powder'.

People with ill-fitting dentures should seek help from their dental care professional, rather than compensate for poorly fitting dentures by using excessive adhesive. 

Polident Denture Cleanser tablets contain no zinc and are not affected by this announcement.

GSK will soon be introducing zinc-free versions of Super Poligrip 'Original', 'Ultra Fresh' and 'Extra Care'. Zinc Free Formula will be clearly shown on the new packaging.

Consumers with questions may call GSK toll free on 1-866-640-1017.

Much of the healthcare reform debate in the Senate over the last week has focused on the possibility of importing pharmaceutical products into the United States from other countries. Both the FDA and Secretaries of Health and Human Services (HHS) in Democratic and Republican administrations have warned that allowing importation could open our borders to counterfeit drugs, cheap foreign copies of FDA-approved medicines, expired and contaminated drugs, and drugs stored under inappropriate or unsafe conditions. If these drugs are allowed to enter the American medical supply stream, patients could be given medicines that at best are ineffective and at worst are harmful or even deadly. 

A recent Washington Post story highlighted these risks. A worldwide raid involving Interpol officers in Europe and drug agents in the US uncovered almost 800 alleged packages of fake or suspicious prescription drugs and shut down 68 alleged rogue online pharmacies.  The Post story noted, "[d]rywall material, antifreeze and yellow highway paint have been found in counterfeit pills."

If the safety risks were not enough, there is no guarantee that importing medicines will actually save consumers money. There is nothing in any piece of importation legislation that guarantees or requires that any potential cost savings from importation will actually be passed onto consumers. Experience with "parallel trading" of pharmaceuticals within the European Union suggests that profit- taking by middlemen (importing and exporting wholesalers and retail pharmacies) will substantially erode any savings potentially available to patients.

Given the increased safety risks and small potential for consumer cost savings, importation of pharmaceuticals is a risk we cannot afford to take.