February 2010 Archives

Yesterday's seven hour bipartisan extravaganza televised live on CSPAN gave viewers the opportunity to see first-hand why health reform has been stalled in Congress since January.  Despite President Obama's efforts to highlight areas where Democrats and Republicans agree, the party-line talking points triumphed for most of the day.

Through all the talking, those of us who still believe reform needs to be comprehensive and not just about insurance coverage found small glimmers of hope. Senator Tom Coburn (R-OK), a physician, spoke most eloquently of the need to better coordinate care and tackle chronic diseases by focusing on prevention. These ideas are central to controlling healthcare costs. Chronic diseases account for three-quarters of healthcare spending. Congress and the Administration must make every attempt to enact legislation that--at a minimum--includes prevention and wellness provisions to help drive down costs for chronic disease, thus driving down costs in the entire system.  No matter which side of the aisle holds a majority, this is some common ground where we all can agree.

Read GSK's full position on healthcare reform

GSK is proud to announce that this week were named one of MIT Technology Review's 2010 TR50--the magazine's first annual list of the 50 most innovative companies in the world.  Along with 49 of our peers spanning energy, computing, biomedicine, materials, and the Internet, GSK was evaluated based on our business model, strategies for deploying and scaling up technologies, and the likelihood of success.

Our scientists are working hard to discover new ways of treating and preventing diseases.  We recognize that we must improve our ability to deliver medical innovations to address unmet medical needs such as cancer, Alzheimer's and chronic diseases that threaten to overwhelm our healthcare system as our nation's population ages. 

Our success depends on a vibrant and productive R&D function. To this end, we have established an innovative R&D structure that encourages creativity and facilitates the accelerated discovery and development of new medicines.  We also build collaborations and links with other research groups, biotechnology companies and academic institutions to help develop transformative scientific concepts.

This award acknowledges our work to discover and develop medicines to achieve our mission of helping patients do more, feel better and live longer. 

We are honored by the recognition. 

For more on the 2010 TR50 visit http://www.technologyreview.com/companywatch/tr50/.  

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.

I've often joked that not a day goes by when I don't receive an email reminding me that we're missing the boat on how to "Use Facebook Effectively" to reach our customers, or "Master Twitter for Media Relations" or "Communicate Effectively in the Social Media Age."   You know what I'm talking about.  The white papers, conferences and tele-seminars built around so-called social media "best practices" have become a cottage industry.

We recognize that some may see us only taking baby steps in this still very-much unfolding milieu,  and we've publicly confirmed this is indeed terra incognita.  We're constantly exploring and hopefully learning.

One thing we've found with this blog is that while readership is pretty good, we ain't getting many comments.  And we're not the only one who's noticed. 

Should this relative paucity of comments be taken as a signal that we aren't fully "engaging?"  We'd certainly like to have more ongoing back-and-forth dialogue with our readers on the blog (btw: we seem to have much more "engagement" on Twitter), but perhaps it is unfair to use the amount of comments as a bell-weather of success.  Based on readership it seems we've been able to provide company information and perspective on a range of issues here that was never available to us before.

So the jury is still very much out on "the right" way to do this I think.  But we will continue to try and improve and engage until we indeed get caught doing it right.

A brief update on our company's efforts to help the people of Haiti:

The first wave of our donated medicines have been utilized rapidly for first-line treatment.  These have been provided from stocks held in the warehouses of our non-profit partners, such as AmeriCares, Direct Relief International, Health Partners International of Canada, IMA (International Medical Assistance), MAP International and  Project Hope. 

Following specific requests to support primary healthcare needs in the medium- to longer-term, GSK has donated significant volumes of antibiotics, as well as respiratory and diabetes treatments, valued at $10 million.  Additionally, GSK's consumer division has provided a range of consumer products, including toothpastes, antacids, pain relievers and vitamins.

Last week, we made a cash donation of approximately $408,000 to the British Red Cross to help meet the water and sanitation needs of those affected by the disaster.  A Mass Sanitation Unit has arrived in Haiti with the British Red Cross emergency team.  This will support up to 20,000 displaced people by constructing 200 emergency latrines and distribution of essential hygiene kits. The provision of water and sanitation facilities can significantly reduce infections and mortality rates following a disaster.   See Red Cross worker Sharon Reader's blog for more details.

In addition to providing product donations and financial support, we are proud of the contributions of our GSK employees currently working in the PULSE program, who have taken on additional responsibilities to support emergency response partners working on the front line of the relief efforts.

Our colleague Maria has written about her local church's efforts through Christian Haitian Outreach (CHO).  There is some good news in her latest report:

"One of our board members who spent a week in Haiti reports that for blocks in every direction outside our compound, almost everything is destroyed. CHO is like a beacon of hope in the midst of much devastation. Activity on the compound is quite orderly as everyone settles in to a "new normal" for the next several months. The children are sleeping in tents, and hundreds of local people have erected a tent city at the back of the property.  Fortunately, not a single child or adult on the CHO compound was killed or seriously injured.

Also:

• Supplies were low after the quake, but the children never went a day without food.
• A 24/7 security plan is functioning well; the walls are intact except for one small area.
• Deliveries of fuel for the generator are in place, so they have power to pump water.
• Sufficient food is now on hand; a plan to ensure a regular supply is being arranged."

GSK is committed to providing whatever we can in response to the huge needs emerging in Haiti and will continue to review requests from our established partners.

This week, Science published a policy paper I wrote on the legal framework that governs patent protection for pharmaceuticals in the United States.  

In the last 25 years, the cost of drug development has skyrocketed--from about $230 million to more than $1.2 billion.  Pharmaceutical companies like GSK protect this huge investment with two kinds of protection: the exclusive ownership of our own clinical research and patents. 

Intellectual property is undeniably vital to our industry.  However, US law allows generic competition in some circumstances as early as five years after a product is introduced, leaving little time to recoup investment in innovative R&D.  Further, US courts sometimes retroactively change standards for patent protection long after large R&D efforts have been started, which increases the risk to defend and rely on patent protection.

We believe it is time to update our legal system to take into account the rapidly increasing cost and time involved for drug development. Amendments to the Hatch Waxman Act, which dictates patent protection law for pharmaceuticals, could substantially increase the number of drugs in the R&D pipeline.  Additionally, patent protection should be predictable and secure.  Basing the patent system on a consistent set of laws will allow us to protect our investment and innovation over the long period of pharmaceutical R&D. 

GSK supports reform of US patent laws, which we believe will encourage more research and, ultimately, result in more medications for patients.

It may sound like a cliché, but as I have progressed during my 17 years here at GSK, determined to add value, I continue to wonder what it takes to be a great leader here in our company.  Certainly I have met many on my journey here, through my job opportunities and rotations, both in the field and in Philadelphia, but what else should I be doing to be considered a GSK leader?

Last fall, I was honored to be included as one of 20 people chosen to have a private lunch with our CEO, Andrew Witty.  Like many good leaders, he was genuinely interested in our feedback and asked us to speak our minds.  Career development and advancement challenges were the most popular issues discussed.  When Andrew asked us about those challenges, we felt that it came down to determining which career path to take and what jobs were considered appropriate to becoming a successful leader at GSK.

Andrew shared with us his own experiences of holding several positions within his first 5 years--learning many facets of the organization, but not necessarily becoming an expert in any one.  He discussed our company's culture and described the type of leaders he would like to see at GSK.  After a couple of hours, we ended as Andrew needed to get to his next appointment.  That is when an idea popped into my head.  I had nothing to lose, so I asked Andrew a question.  "Would you ever consider letting me shadow you for a day, to witness first-hand what the top leader of our company does?"  To my surprise, he thought it sounded like fun.  He wrote a note to himself and said he would follow up with me when he got back to the UK.

A couple of months later, the date set, I would have the opportunity while Andrew was in the US to deliver a speech to the Council on Foreign Relations in New York.  Appropriately, the topic would be on how GSK was going to be a leader through innovation and development of medicines to battle neglected diseases in under-developed countries.  Of course I prepared myself by reading everything I could get my hands on about Andrew and some of the more global challenges our company faces.  What I could not have prepared for was the whirlwind of a day I was about to be a part of.  (Including an interview with the New York Times--the profile was published today!)

We met at 6:30AM and off we went.  Honestly, I was pretty nervous at first.  I mean--what an opportunity!  A million things ran through my head and I also felt responsible to properly represent the US portion of our company well.  Andrew and his staff did a great job, making me feel at ease and a welcomed member of the entourage that would hustle from place to place that day.  Off we went for the first event of the day; the speech with Q&A to the Council kicked things off.  Immediately after the event, Andrew was interviewed by a reporter from the Financial Times, followed by a phone interview with the BBC.  We were back into the car to go to Forbes for another interview and then to the New York Academy of Sciences to meet and answer questions from a blogger group.  This was all before lunch!

Of course it would be a working lunch followed by a meeting with the Wall Street Journal.  We took a short walk to a café across from Rockefeller Center to meet with a journalist from Management Today.  Beyond the brisk pace of the day, it amazed me that no matter what question was asked of Andrew--the announcement about GSK opening up our patents, technology, and lab in Tres Cantos, Spain to help drug development for neglected diseases; the industry trends; the impact and fate of the proposed healthcare reform; or how he was bringing the GSK culture to life, he answered with thoughtful transparency, integrity and respect for our company and always with a focus on the patient. 

During the day, Andrew shared with me that he wanted people at GSK to be "restless" and not get complacent about bringing great innovation and ultimately new medicines to patients we are trying to help.  "If we are restless, we will work with a sense of urgency and challenge each other to be better and be more focused on our customers (patients)," he said.  I asked him for an example of what I could do as one of those many thousand to demonstrate restlessness and help GSK be a better company.  He suggested that "if each of us gives 10% more to our jobs, imagine what we could accomplish each and every day."

Our whirlwind of a day was done, but my learning continued while I reflected on what an honor and privilege it was to spend a day with Andrew and his staff.  I learned much about our company and the man who leads it and have a renewed pride about what each and every one of us does every day to improve the lives of so many.  Through the entirety of the experience, I also think I have a better idea about what we need to do to be leaders at GSK.

To some degree, we must be fearless.  Had I not taken the opportunity and assumed some risk by asking for the opportunity to shadow, I would never have had such an enriching experience.  If you are a sales person, you have to ask for business.  If you are a scientist, you have to ask--why not?  We have to push beyond our comfort zone to take on the new challenges of today and innovate.  As Andrew explained, we need to also be restless. We need to work with a "sense of urgency" and feel comfortable challenging each other to improve and not stagnate--not just with the intent to be recognized and moved up in the organization, but to broaden our experiences laterally in other areas to improve.

Finally, as exampled by Andrew himself on my shadow day, leaders need to be both prepared and hard-working.  Andrew worked full-court press the entire day and in every situation he and his staff were fully prepared to meet the challenges each experience offered.  Without that preparation, we are ill equipped to take advantage of opportunities when they do present themselves.  And, if we each as leaders give 10% more every day as Andrew suggested, we will also increase our chances that something great can happen.  The shadow day with Andrew Witty, for me, was just a start.