More than Medicine

PharmaMom: This is nuts.

2009-11-20T15:43:13Z

A fairly regular post from a busy mom concerned about raising healthy children.

A month or so ago we received an email from our kid's preschool advising us that due to the amount of children with food allergies, nut products would be restricted. This meant PB&J, PB & banana, and PB & raisin sandwiches (lunch staples for our kids!) would need to be replaced with an alternative. This rule applies the youngest children, 18- 36 months; the ones who can't list off their food restriction or ask you if the brownies are gluten-free.

This week Pediatrics released a study stating that '4% of U.S. children have food allergies.' We are well aware that more kids are showing food allergies--but why? The study offered a few theories for the increase, one being that our kids are not exposed enough to germs, which doesn't allow their immune systems to build up protection. Theories are helpful; but the study noted that more research would need to be done to determine the root cause.

There is an 'allergy table' at our preschool and now a nut-free environment for the littlest ones. We are pretty fortunate, our kids haven't shown any food allergies (yet?) and we want to protect our kids but we need answers, Let's hope we get them before all those seats fill up.

There's no time like the present to quit smoking.

2009-11-19T18:12:45Z

After losing my father to smoking at a very young age, I am fully aware of the devastating impact that premature death from smoking can have on a family. As the leading cause of preventable death and disease in the U.S., tobacco use shortens the life span of a smoker by more than ten years, according to CDC statistics. What's more, 1,000 children become regular smokers each day, adding to this horrible statistic.

As we approach the Great American Smokeout, sponsored by the American Cancer Society, and the quit season that continues through the arrival of the New Year, we are reminded that nearly 70 percent of smokers nationwide want to quit. We know that quitting is not an easy task and few smokers are successful on the first try. It often takes several times for a smoker to quit for good and many don't realize they are battling both a physical and psychological addiction. There is no time like the present to address their needs and focus on helping those interested in overcoming their addiction to cigarettes.

Highlighting access and availability to resources and tools that help smokers quit needs to be a primary focus for the tobacco control community. Luckily, tools do exist including state quit lines, online services, telephone counseling, and over-the-counter cessation medications, such as therapeutic nicotine, available at retail outlets across the country. Smokers should seek help from products, programs, and services that are proven to boost one's chances of succeeding. It is also beneficial for smokers to talk with their doctor to track their progress and develop a personalized plan. Finally, it is up to us to continue to expand and develop new, innovative ways that are safe and effective in helping smokers quit.

Friends and family play such a crucial role in helping a loved one quit. It is important for smokers to find a support system in their lives - people who provide encouragement and praise along the journey, and people to celebrate with when they have successfully quit.

There is not a day that goes by that I don't regret the lost years with my father. But, in my current role, I am privileged to help in this fight against the tobacco epidemic each day. There is much that we can do for those who want to quit and it is my hope that we can achieve the goal of reducing and eventually eliminating the death and disease that is caused by tobacco in this country.

Today is World COPD Day

2009-11-18T16:31:09Z

Today is World COPD Day and though many people may not know what COPD is, more than 12 million people in the U.S. have been diagnosed with the disease and it is the fourth leading cause of death. COPD stands for Chronic Obstructive Pulmonary Disease--a progressive, life-threatening lung disease that includes chronic bronchitis and emphysema.

People with COPD have airflow obstruction, which leads to the hallmark symptoms of COPD:

· Chronic cough

· Chest tightness

· Shortness of breath

· Increased effort to breathe

· Increased mucus production

Over time patients with COPD suffer from shortness of breath so severe that it interferes with their most basic daily activities including sleeping, talking, and even dressing.

The gradual loss of lung function, coupled with other symptoms and exacerbations, which are episodes when a patient's symptoms are markedly worse, often leads to hospitalization and can be disabling and life-threatening.

COPD can be treated. While there is no cure for COPD, there are treatments available that help patients reduce symptoms of the disease. By enabling better management of COPD symptoms, treatments can improve lung function, increase quality of life, reduce exacerbations and slow disease progression. The earlier a diagnosis is made, the more effective the treatment will be.

Doctors generally advocate lifestyle changes first to slow the progression of COPD. If you are a smoker, quitting smoking is the best way to prevent COPD or stop its progression. It is never too late to quit smoking!

Many people have COPD and have not been diagnosed--it's estimated that another 12 million people have the disease and don't even know it. Yet, it is a life-threatening disease that will get worse if not treated. A simple breathing test called spirometry can help diagnose COPD. The test is quick, painless, and can often be performed in your doctor's office.

GSK is proud to support World COPD day helping raise awareness of COPD and the need for better patient care. For helpful resources on COPD visit the National Heart, Lung and Blood Institute's website or the >American Lung Association website.

Setting the Record Straight

2009-11-16T20:41:43Z

We were surprised to read a Dow Jones story last week reporting that GlaxoSmithKline had "refused" to sell some of its medicines to a generic manufacturer. We were surprised because, in fact, we have offered in writing to sell the medicines and have outlined the steps necessary--primarily confirmation that FDA would allow the sale and approve the generic company's planned research.

"After FDA has considered the issues...GSK would be pleased to work with (the generic company) consistent with FDA's conditions to address GSK's business and liability concerns," conclude the GSK letters, which the reporter had obtained. The generic company has not responded to GSK.

The Merriam-Webster Dictionary defines "refuse" as "show or express unwillingness to do." The characterization does not fit this situation and the Dow Jones story did not accurately report our position.

We wanted to share these facts and set the record straight.

Thoughts on the FDA Meeting

2009-11-16T17:52:35Z

As most of this blog's readers are aware, last Thursday and Friday the FDA held an important meeting on social media and internet marketing. For two-full days, representatives of the industry (click here for PhRMA's testimony), agencies and patients presented to FDA's Division of Drug Marketing, Advertising and Communications on how technology and Web 2.0 have dramatically changed the way health information is exchanged.

For those of us who have been deeply involved in this space, most of the testimony did not cover new ground but it did demonstrate how extraordinary are both the opportunity and challenges presented by the explosion of digital communications and user-generated content. A central question is how best to ensure patients have truthful, balanced information about treatments--in our case, prescription medications--in such an expansive, and ever-evolving medium. A corollary question is what our proper role should be in making this happen.

FDA should be applauded for holding this meeting--and listening patiently to some 76 presentations! It is clear the agency will need time to digest all that has been presented (the docket is open for comments through February 28, 2010). The meeting was a great time to connect with friends and colleagues from across healthcare who share our excitement with how new media is transforming health care communications. We look forward to working together with all of them and FDA toward developing a framework that results in the absolute best outcomes for patients and their caregivers.

(PS: Our friend Bob Pearson has posted a very comprehensive overview of the meeting here.)

When is the last time you thought about your skin?

2009-11-16T15:38:16Z

Those of you outside of the dermatology community may not know that November is National Healthy Skin Month. But for those of us who think about skin on a daily basis as part of our jobs, this is an opportunity to spotlight broadly the importance of skin.

Skin is our largest organ. It protects our bodies, serves as a barrier against infections, and helps us maintain our body temperature. Healthy skin is one important measure of our overall health, but is an often forgotten and neglected part of our overall healthcare regime.

National Healthy Skin Month is a great time to focus on our own skin health, and I encourage everyone to take a few moments this month to consider ways to improve and maintain your skin health, such as:

· Get regular skin health screenings with a dermatologist.

· Regularly inspect your own skin, and make note of any changes, such as moles, redness, bumps, etc.

· Ensure that your skin is getting enough moisture--especially as some climates are entering the colder, dryer winter months--by drinking plenty of water and applying moisturizer to your skin daily.

· Apply SPF daily. Even in the winter months, the sun's rays can have damaging effects on our skin.

Healthy skin should not be a concern just this month, but on an ongoing basis, and here at Stiefel we spend 365 days a year focused on helping patients worldwide achieve healthy beautiful skin through the products and programs we put forth. So how is your skin health today?

(Image courtesy of Stiefel.)

Talking Politics with Your Doctor

2009-11-11T18:19:59Z

I've ended up on the email distribution list of seemingly every marketing/communications vendor and market research outfit around. I have chosen to stay on many of these lists mainly because, when I have time read their emails, they sometimes contain interesting or even provocative information.

This morning is a case in point.

One firm has issued a brief report, Doctor-Patient Discussions About Healthcare Reform. Pulling from its collection of physician-patient interactions recorded during the first nine months of the year, the firm discovered that "Physicians are more likely than patients to initiate discussions about healthcare reform during in-office visits." Their data also shows:

Physicians are far more likely to use the term "socialized medicine" than any other term, such as "universal health care," "national healthcare," or even "healthcare reform"
Both physician and patient attitudes toward healthcare reform were overwhelmingly negative
The prevailing fear is that proposed reforms would increase costs and decrease the quality of healthcare by limiting physician and patient options
Interestingly, physicians and patients were also likely to express frustration with insurance company intervention in healthcare delivery, with a sizeable number of physicians confiding in patients that frustration from insurer intervention makes them regret becoming healthcare practitioners

Curiously, physician-patient dialogue on healthcare reform peaked back in February, according to this data, but September and October are not accounted for, and one would expect this discussion would have significantly ramped up (I know my Dr. brought up the issue, unprompted, in my last visit).

From the information provided, there is no way to know details about the underlying data. But if their information is correct, it is certainly concerning. Healthcare reform ultimately is about the patients and their doctors. For reform to be successful, they've got to believe it will work.

To screen or Not to screen...

2009-11-11T13:29:31Z

That is the question: At least when it comes to regularly screening men for prostate cancer, a disease that strikes one in six US men. Some critics of screenings argue that too many men are being diagnosed with less than life-threatening cancers that are being treated as if they are a mortal threat; overtreatment, in turn, may unnecessarily lead to some serious side effects.

But let's not lose sight in this debate that far too many men--some 27,000 in the US this year alone - will die from prostate cancer. That's why we agree with the American Urological Association, which recommends education, risk assessment and detection of prostate cancer be offered to men 40 years of age or older. It's true that not all medical bodies are this proactive when it comes to prostate cancer. Where most do agree, however, is that men should talk to their doctors about the appropriateness of prostate-cancer screening and that they have access to such screening.

GSK has an ongoing focus on men's health concerns, and we're proud to support a new prostate-cancer education collaboration of five major advocacy organizations. Because when it comes to cancer, the importance of continued research and education are beyond debate.

Shutting off the Spigot?

2009-11-09T20:31:07Z

A piece in this weekend's New York Post ("Shutting off the miracle-drug spigot") reminds us of the extraordinary stakes at play in the current healthcare debate, particularly when it comes to continued investment in pharmaceutical innovation.

Suggesting that some in Washington "are out to cut health-care costs at the expense of the research-intensive (as opposed to generic) pharmaceutical industry," it rightly points out:

.... Yet drugs often improve the span and quality of life in a remarkably cost-effective way. Innovative new drugs have helped many patients avoid costly hospitalization, for example. From 1980 to 2000, the number of days in the hospital per 100 people fell from 129.7 to 56.6, a drop of 56 percent--so that Americans avoided 206 million days of hospital care in 2000 alone, according to Medtap International, which provides health economics and outcomes-research services.

Our industry's promise to provide patients with the best care and therapies possible is built on a huge investment in innovation--$65 billion in 2008. We recognize that this innovation is meaningless unless we are equally committed to ensuring access to our medicines. So just as health care reform must broaden that access, it must also reflect the fact that our medicines help people 'do more, feel better and live longer,' as echoed in our corporate mission. That is, they are implicitly part of the solution, and that critical piece is only made available through continued investment in cutting edge scientific research.

The article continues, "even after drugs are approved for marketing, only about three in 10 now recoup their development costs." This means, we make a lot of bets--smart, informed bets, but there is risk nonetheless. As the Senate takes up consideration of their healthcare reform legislation, when it comes to innovation, patients deserve the best. We cannot afford to roll the dice.

(Image courtesy of Wikipedia.)

What a relief effort!

2009-11-05T18:59:03Z

We all fill a number of interesting and very important roles here at GSK as we discover and develop life-saving medicines, and make sure these medicines end up in the hands of the people who need them. I love my job!

That being said, I envy what some of my colleagues do on a day-to-day basis, like my friend Sue who coordinates our product donations.

Sue never has any two days that look alike. She has the opportunity and challenge of her workday being turned completely upside down by events in the news--in a way international news rarely affects mine.

When a humanitarian disaster occurs, Sue is one of the first people to respond to the call. We are prepared to respond to disasters, along with our five main US partners: AmeriCares, Direct Relief, InterChurch Medical Assistance, MAP International and Project HOPE, because of the excellent internal management of people like Sue.

Though there are similar programs out there, our product donation program is unique. A few differences set our program apart. For example, we commit to donating products with a shelf-life of a year or more. We also include our product donations in the same production plan as our for-profit stock. We account for these donations at the production price as opposed to wholesale costs.

Ethical Performance magazine recently highlighted Sue and the Product Donations Program. Click to read more.

PharmaMom: Like Mother, Like Daughter

2009-11-04T15:41:55Z

A weekly* post from a busy mom concerned about raising healthy children.

More than 40,000 people gathered in New York this past weekend all with the same goal: to run the ING NYC Marathon. I'm inspired when I read about the amount of people who participate in these types of events--but my initial inspiration came a year and half ago when I watched the 38-year Constantina Tomescu-Dita win an Olympic gold medal for the marathon.

The next day I started running. I was inspired by her accomplishment. It's not that I suddenly had a burning desire to run a marathon in less than 3 hours or run a marathon at all for that matter--I just wanted to get moving, start a routine. I did, and still am.

What I didn't expect is how this would influence my daughter. Her teachers once told me how she walked around all day with her pants rolled up talking about going for a run. I embraced this excitement--and when she asks to run with me I say yes, even if it is a quick spin around the block.

We are really excited this year since my daughter can participate in Kids Fun Run sponsored by the Philadelphia Marathon. We are counting down the days for her run--marking off the calendar and 'training.' I love watching my daughter get excited for her run and I'm pretty pumped for myself too as this event marks a year of running for me. Last year it was the 8K, this year I'm tackling the half marathon.

I couldn't have asked for anything better--I want my kids to be excited to exercise and would prefer not to force it. We all know how hard it is to fit in exercise but the importance of it outweighs the annoyance--even if it is a run around the block!

*Editor's note: Well, we're trying for weekly. It's a balancing act, and Rose is doing her best. Good luck in the half marathon, Rose!

Looking Back as RTS,S Moves Forward

2009-11-03T16:25:05Z

Seated from left: Salim Abdulla, Tanzanian PI; Joe Cohen (at microphone); Christian Loucq, PATH MVI; Regina Rabinovitch, Bill & Melinda Gates Foundation

Looking out at the packed room full of reporters this afternoon, ready to announce the progress we have made with the RTS,S Phase III trial, I could not help but think about the past. One moment in particular comes to mind.

It was five years ago, in 2004, in a cramped room in Mozambique. The walls were sweating and so were we as we waited for the results of the very first RTS,S safety and efficacy trial in children. What would be revealed during that unblinding could make or break the vaccine. We were literally at the edge of our seats.

Those early results, later published in The Lancet, were proof that this vaccine could work in children.

Fast forward five years to today; this time we were the ones giving the good news. From Nairobi, we told the world that more than 5,000 children had been enrolled in the pivotal efficacy trial in just six months. No one person could have done this alone, and I am so grateful to every member of the RTS,S team, which has evolved and grown over the years. It has been my honor to work with them.

Today represented a turning point of sorts. It felt like I, along with all the scientists who have worked on this vaccine over the past two decades, was passing the baton to Africa. The future of this vaccine is now in the capable hands of Salim and Patricia, the two African Principal Investigators who joined me at the briefing today, and all of the other talented researchers leading the trial across Africa. As we head into the last part of this journey, they will usher RTS,S into the future on the ground.

For years, people have questioned whether this vaccine would ever see the light of day. And doubts still linger. But today we showed the world that our dream can become a reality in just a few short years. Looking into the future of RTS,S, I cannot help but echo the words of Kenya's most famous son: "Yes We Can." Indeed we must.

ViiV Healthcare--A New Type of HIV Company

2009-11-03T15:13:31Z

I'm particularly excited because today we're launching ViiV Healthcare, a worldwide HIV specialist company resulting from a combined effort by GSK and Pfizer.

In my various roles at GSK, I've had some very interesting windows through which I've been able to view our HIV business. In the beginning--before I worked in HIV--I looked at the disease as so many people do. I only knew what I read in newspapers and had a very third-person, far removed perspective.

But that changed a year ago when I joined GSK's HIV communications team and learned about the real impact of this disease. I became much more passionate about disease prevention, awareness, education, and treatment. Soon I was attending HIV congresses and meetings, and learning more directly about how this disease affects people.

I could see the sense of urgency in their eyes when they talked about HIV treatments, and their hopes for ever-better treatments in the future. Suddenly, HIV was a whole lot more real to me, and I was more passionate than ever about working in this arena.

Now GSK and Pfizer are launching ViiV Healthcare, which seeks to address important issues such as the need for innovative research and improved access for patients.

The central proposition behind ViiV Healthcare is extremely exciting: a robust HIV company with a solid pipeline and deep expertise, but structured to be a smaller and more nimble organization that can respond faster to the changing needs of HIV patients.

I wish everyone at ViiV Healthcare the very best in their new venture. They're doing something that I believe will have a significant impact on how we deal with HIV across the globe. And how can you not be excited by something like that?

More from MIM

2009-11-02T21:26:41Z

Hello from the Kenyatta International Conference Center in Nairobi, Kenya!

It is a privilege to be here among the world's leading malaria researchers. I've had a busy first day already--connecting with colleagues old and new and attending plenaries, symposiums and scientific sessions.

I am really looking forward to tomorrow since we'll have a chance to update the media and many African journalists about RTS,S.

It's great to see the awareness grow about the vaccine--including an important commentary piece in The Lancet by the conference organizers. How few people would have imagined this historic milestone a few years ago?

Tomorrow, joining me at the media briefing, will be two African Principal Investigators who can explain what goes on to make this possible. Salim Abdulla and Patricia Njuguna are just two of the world-class African scientists in Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania who are spearheading this effort. In the months leading up to Phase III, they have coordinated an incredible amount of training and capacity building just to get the trial off the ground. Their leadership has been extraordinary and just another reason why there is so much excitement here.

Will report back again after tomorrow's briefing...

Malaria Vaccine in Final Stretch

2009-10-30T20:00:46Z

The excitement at GSK's Belgium-based vaccine research center is palpable as we make our last preparations to leave for Nairobi, Kenya, for next week's MIM Pan-African Malaria Conference. MIM stands for Multilateral Initiative on Malaria and it is the world's largest malaria meeting.

The conference brings together malaria researchers and control experts from malaria-endemic countries as well as malaria researchers, science administrators, and representatives from other countries, private foundations, governments and international organizations throughout the world.

We'll be giving a progress report on RTS,S, the world's most clinically advanced malaria vaccine candidate. A pivotal Phase III efficacy trial that will involve up to 16,000 children is underway in Africa.

This moment has special relevance to me because I helped invent RTS,S in the late 1980's and I have been working on it ever since. This is truly a shared endeavor, and we've enlisted such great partners as the Walter Reed Army Institute of Research, PATH's Malaria Vaccine Initiative, the Bill & Melinda Gates Foundation, and research centers in the U.S., Europe and Africa.

Malaria kills about 800,000 African children every year and this vaccine has the potential to save hundreds of thousands of lives. I'm proud that the company I work for has not shied away from this technological and commercial challenge, and has invested over $300 million of its own resources in this project.

(To learn more, watch this story on CNBC.)