William Weldon's Speech at the PhRMA Annual Meeting

CHAIRMAN WELDON: Thanks. And good afternoon. Welcome to PhRMA's annual meeting.

If it's possible to be both humbled and proud at the same time, then I am, humbled by the courage of patients and doctors and by the commitment of the scientists in our labs and in academia to find cures and proud of the role we play as an industry in improving the health of patients around the world.

Today we are going to hear from policy makers, doctors, business leaders, and academics about their perspectives on health care. But the most important perspective, the lens through which we will be seen and judged as an industry, is the perspective of the patient.

As important as anything we have done this year out of PhRMA is our renewed commitment to orient all of our thinking and everything we do toward the patient. That is because every decision we make, large and small, has an effect on patients.

So I would like to thank each of you for the tremendous accomplishments we have made this past year. I would also like to challenge each of us to look at what we are doing every day and ask ourselves, "How can I do this better? How can I make a difference? How, in short, can I put patients first?"

When I spoke here a year ago, I talked about four challenges and opportunities facing our industry: enhancing access to our medicines and to health care on a broad basis, providing understandable information for patients and consumers, improving the quality of health care, and continuing to innovate on behalf of patients everywhere.

In every case, we have risen to the challenge. And I particularly want to thank the employees of our companies; the Board of PhRMA; our president, Billy Tauzin; and the PhRMA staff for all that has been accomplished.

We know that we can't rest on last year's accomplishments. On access, we are approaching the one year anniversary of the Partnership for Prescription Assistance. In just that short time, we have helped nearly two million low income Americans get access to assistance programs that provide medicine for free or nearly for free. And that's a staggering achievement.

We've heard from so many people helped by the PPA. Mary Holliman of Lafayette, Tennessee told us and I'm going to quote her "Without PPA, I don't know if I'd still be here today. Each time I fill my medicines, I say thank you. The PPA truly saved my life." It's just great to hear we're making a big difference.

In creating the PPA, we forged partnerships with organizations ranging from the NAACP to Easter Seals to the American Heart Association to the American Academy of Family Physicians. And we did all of this to get the word out to patients.

We now have more than 1,200 patient, physician, and community groups working with us, including organizations that have never before been willing to work with PhRMA.

As Billy has said many times, we have no enemies. We're willing to work with anyone on behalf of patients. And we have sent the PPA to virtually every corner of America from Mobile, Alabama to Modesto, California. And this is to help spread the word about our patient assistance programs.

In the face of this effort, it's hard for anyone, even our seasoned critics, to deny that we are serious about helping patients get the medicines they need.

In addition to making our patient assistance programs more accessible, we also worked hard, along with many others, to make this critical Medicare drug benefit a reality. It's worth reflecting for a moment on the journey to this important benefit. It was a long road, and it wasn't very easy. But in the end, this industry can be proud that we stood up as part of a broad coalition to help support passage of a meaningful drug benefit that also modernizes the Medicare system.

Despite the years it took to get here, the work is only just beginning. As an industry, we are fully committed to making this program work for Medicare beneficiaries across America. We know that change this dramatic and far reaching is not easy and that transitioning seniors has been a challenge. But CMS is addressing the issues. And we are helping seniors by partnering with many others in health care, such as the AARP, the National Coalition on Aging, the National Health Care Leadership Council, and the National Alliance for Hispanic Health.

Side by side with these and many other groups, we are helping seniors learn more about the new benefit. Of course, we're also contributing to this effort through the Partnership for Prescription Assistance, making sure that as seniors and other beneficiaries come to us, we make them aware of the drug benefit and provide the information they need to make a good decision for themselves.

We have made great strides with Medicare and PPA. And we need to stay the course in making both of those programs successful for the long term. Our goal going forward must be to make access to our medicines faster and easier for people who need them.

As we do so, we are mindful of another perhaps even larger challenge before us. And that is ensuring that every American, including people under 65, have access to health insurance. Patients first means the issue of the uninsured must be a top priority for this industry. Failure here should not be an option.

America's uninsured are not all alike. Some are unemployed. Many are in working families. Some are young adults. Some are immigrants. Some are very poor adults without children. And some are middle and upper class income people who choose to go without coverage.

Finding a solution that will help all of these people will require a more than one size fits all approach to policy. As a first step towards contributing to thoughtful reform, this year PhRMA developed a framework for addressing the issue of the uninsured. And we began working with the Health Care Leadership Council on legislative and practical approaches.

One effort is focused on helping small businesses in some markets identify insurance options for their employees. Many other approaches can help as well, such as tax credits for low wage earners and small business owners. At the same time, more is being done to enroll people who are eligible for public programs that serve as a safety net.

In the spirit of cooperation in putting the patient first, members of our industry are also working closely with many organizations, including some of those same seasoned critics I alluded to earlier, to find ways to get affordable health insurance to more people.

We recognize, however, that arriving at a long term policy solution will take time. And that progress in terms of policy means little to uninsured patients, who need medicines today.

So let's be proud of what we have achieved, but let's also be humbled by the struggle of millions of uninsured Americans to access health care for themselves and their loved ones.

The success of the PPA should be a constant reminder to us of the failure of the health care system to provide for millions of Americans. These Americans are coming to us through our patient assistance programs because there is nowhere else for them to turn, because they can't live without medicines and because they have no other way to get them. So let's not let these individuals down. Let's use what influence we have as an industry to press for better policy solutions for the uninsured.

Over the next year, we will be adding our support to states that are moving to help cover the uninsured. From these experiments will come innovative approaches to address this need.

Further from our shores, our industry has made a substantial commitment to the developing world, a commitment that even our staunchest critics cannot help but to notice.

A recent IFPMA study estimates that the industry has contributed more than $4.4 billion worth of medical donations to low income countries over the past 5 years. And a London School of Economics audit suggests it is much more than that.

We know that free or low cost medicines alone cannot solve these problems. And many of our member companies are actively working with governments and others in civil society to address the significant infrastructure issues in these countries.

While we are focused on expanding access to health care here and around the world, we need to remember that not all health care is created equal. Putting patients first means we're working to ensure that the health care that is provided around the world is of high quality, that it reflects today's science and today's technology.

It turns out that quality is a surprisingly complicated idea. If we were in the automobile business, it might be easier to figure out what quality is.

An average consumer has a pretty good idea of whether or not the car they bought is of good quality. Does it rattle? Does it feel solid? Does it perform well?

But asking the consumer to evaluate the quality of their health care is far more complicated because health care is a much more intimate, varied, and complex set of interactions. Simply put, quality in health care means providing the right intervention at the right time in the right setting in the right way for the right person and realizing the best possible result in terms of health and well being.

Getting all of that to happen is not so simple. It involves the cooperation of hospital administrators, physicians, nurses, pharmacists, innovator companies, employers, policy makers, payers, patients, and patients' families, just to name a few. It also involves all stakeholders seeing themselves as working together for patients.

Complicating all of this, another word has crept into the discussion about quality. And that word is cost, a word that really has no place in a discussion about quality. Does that mean we should not address cost? Of course not. We live in the real world. And the cost of treatment and the value of innovation that innovation delivers is an important consideration.

Let's make sure we distinguish between cost and value. Terms like "evidence based medicine" are being used by some to, in effect, ration health care, to balance cost versus benefit. And that's a flawed idea because it ignores some basic questions. Costs for whom? Benefit for whom?

Evidence based medicine can be a great thing if evidence based medicine means gathering the best evidence to make decisions for the individual patient. It's a terrible idea if it means that we are substituting economic judgments for clinical judgments because economic judgments usually put populations or hypothetical average patients ahead of real individual beings treated. And that is a mistake.

Patients don't care if a medicine works well for most people but not for them or their loved ones. So I would suggest that as we continue to speak about quality, we need to embrace two important but distinct ideas. And we need to work hard to keep those ideas separate.

First, quality health care is about patients. It's about getting the whole of any health care system here or in other parts of the world to work the best it can to get individuals patients well.

That means preventing disease when we can, detecting and treating it early, and helping patients live with illness. We need to do everything we can to make health care systems deliver all of that for patients. Let's be as innovative as we can. Let's work in partnership with everyone we can to achieve those goals.

Second, innovation needs to deliver value to those who are underwriting it. I believe that it does. You believe that it does. And we should not be afraid to honestly and openly examine those questions.

Of course, an indispensable part of quality health care is the ability and accessibility of good information for patients, physicians, and all others in health care.

In the past year, we have made great progress on this front in the United States. Our new voluntary code for directed consumer education went into force in January. And the PhRMA Office of Accountability is reporting our progress in meeting with principles we articulated.

But in many parts of the world, health care information is simply not available to patients. And there is work to be done to improve this. Patients benefit from reliable information that educates and advances health.

On another information front, we have become more transparent than ever before about our clinical trials with clinicalstudyresults.org. This is a great start, but often the information that is available is too difficult for consumers to access and understand.

We need to work in partnership with government, health care providers, and patient advocacies to educate the public about clinical trials and to make the information useful and relevant to each audience.

While we are at it, we should also help the public understand how we actually do conduct our science. There is a good deal of misunderstanding on this point. We need to do more along with other stakeholders to educate the public that the benefits of medicine do come with risks and that the art of medicine is in balancing the benefits and the risks within the context of an individual patient.

Based on our work this year, I am also pleased that our industry is taking a more active role in leading disease prevention efforts. Certainly each of our companies has been involved in prevention for a long time, but taking leadership as an industry to demonstrate that our first priority is health, not just treating disease but preventing it as well, this is a critical part of fulfilling our mandate to put patients first.

The 5 and 5 healthy town program we are piloting is an excellent first step in that direction. We know what patients need and what the public expects of us. And we should keep building momentum in those areas.

One aspect of information where I would challenge us to be even more active is in communicating about the safety of our products. I think there is an assumption on the part of some in the public and even some policy makers that this industry is not interested in the safety of our medicines. Nothing could be further from the truth or from the reality of what we do every day to help ensure patient safety.

As an industry, we have every incentive to make the safest products possible while still producing medicines that are effective in treating disease, but our medicines are not taken in a laboratory setting with strict controls. Our medicines are taken in the real world, where people may not tell their doctors about other drugs they are taking or they may forget a pill and then double up on a dose.

We should not be defensive about the issue of safety but, rather, lead in talking about ways that taking medicines can be made immediately safer by educating consumers about how to take their medicines properly, not overusing, misusing, or under using them. The 5 and 5 pilot will advance this dialogue with the public.

We are also taking a leadership role in advocating for health system improvements, such as health information technology and e medical records, approaches that can dramatically reduce the incidence of drug related injuries.

But of the topics that I have discussed this afternoon, the thing that patients want most from us and expect from us is innovation. Innovation is our most important job. Patients depend on us. They expect us to create new treatments and new cures. Without innovation, we simply cease to exist.

Perhaps that is one reason why industry investment in innovation is at an all time high. But, to be blunt, patients are simply waiting too long for new medications.

We can do better, but we cannot do it alone. Society has to want and believe in innovation if we are to have the systems that will allow us to deliver it.

Robert Wood Johnson said and this was in 1947, but it still holds true today "Institutions, both public and private, exist because the people want them, believe in them, or are willing to tolerate them."

The day has passed when business was a private matter. The resources our companies invest in innovation won't matter if our system doesn't encourage it. By encouraging innovation, I mean more than having the financial incentives in place to allow us to innovate. It also means having a regulatory framework that is itself innovative and that facilitates innovation.

The FDA is working to improve this process, but they are under funded and understaffed to do it. And without the support of policy makers and the public for a more patient centric approval process, they won't be able to get there.

Speeding the process of development and approval does not mean cutting corners or compromising safety. It means taking advantage of the newest knowledge and the latest technology. Perhaps it means using biological markers earlier in the development process or in silicone technologies to gain information that otherwise would take years of clinical trial follow up.

In the process, we could spare some suffering, help people get effective medicines faster, and enhance lives. Our goals in this very important area of innovation are achievable. Patients struggling with disease want us to keep pressing to bring new medicines to them. It is what we must do. And I know it is what we will all do in the years ahead.

Putting patients first means all of the things I discussed today: enabling access, providing information, supporting quality, and delivering innovation that adds years of life to patients around the world.

In closing, I am looking forward to continuing to work with all of you and to offering any support that I can to Peter as he assumes the chairmanship. The issues we are tackling as an industry are enormous, but the promise of what we do is even greater. And that promise must sustain us as we drive forward. Only by working together with others in health care, as we have done this year, will we find solutions and realize the promise of our science.

If there is any industry that can find innovative solutions, I am confident it is this one. We have achieved far more this year than anyone would have imagined. And I am truly grateful for each of you for making that happen.

And we should really be proud of what has been done. At the same time, we should be very humbled by what is left undone by the challenges that remain and by the debt that each of us owes to the patients, who are the reason for our very being.

I would like to thank each of you for allowing me the honor of serving as your chairman this year. Thank you very much.