Putting Patients First to Keep Health Care in America the Best in the World Putting Patients First to Keep Health Care in America the Best in the World

Keynote Address Before The American Legislative Exchange Council Annual Dinner
August 2, 2005
Gaylord, Texas

Billy Tauzin
President and Chief Executive Officer
Pharmaceutical Research Manufacturers of America

Being here tonight is very special. It is a great honor, of course, to be asked to give this year’s keynote address to the American Legislative Exchange Council’s (ALEC) annual leadership dinner, and it is exciting to see such great bi-partisan support of Thomas Jefferson’s principles of trusting in the people and limited government. But being here in Texas – right next to Louisiana where I grew-up – is like coming home to a great meal with old friends and family. As some of you may know, Texas is now my home away from home, and it is where I come to recharge my batteries and keep my perspective on life.

The visions and values embodied by Thomas Jefferson and exemplified in the work of ALEC and its members are the values and vision that have inspired me throughout my political career.

First, as a proud member of the Louisiana State Legislature and then during my 25 year Congressional career, I have tried – from both sides of the political aisle -- to follow the convictions that I know I share with many of you: Individuals matter and government works best when it gets out of the way and lets people make their own choices and the free market work.

For me, politics has always been a simple matter of trust. As a legislator and Member of Congress, I not only asked for the people’s trust at election time, I let their values and their innate ability to make the right choices for themselves and their families be my guide.

Trusting people and letting the competition of the free-market place provide efficient and effective solutions is the lesson that I have taken with me in my new job as President and CEO of the Pharmaceutical Research and Manufacturers of America.

America’s research-based pharmaceutical companies are some of this country’s – indeed the globe’s – most dynamic, creative and innovative enterprises. Today, this country develops 60 to 70 percent of the world’s new medicines. These miracle medicines are both literally and figuratively revolutionizing health care in America and around the world.

Because of the spirit of innovation and creativity that drives the pharmaceutical industry, millions of patients with deadly diseases and who once had no hope now live longer, healthier and more productive lives. And, millions more still struggling with incurable conditions now can hope that a treatment or even a cure is on the horizon.

But America’s research-based pharmaceutical companies are unlike any other business. We don’t build cars or washing machines or make ice cream. We are not in the entertainment business.

We are in the business of health – and health is everyone’s business. We exist for one reason only: To create cures and treatments to help people keep or regain their health. But nothing we do matters if patients don’t trust in the safety and effectiveness of our products or can’t get the medicines they need.

In short, our business is built on keeping the trust of patients and health care providers. Patients and doctors must trust that we not only create great products but are forthright with them at all times. Keeping this trust, especially when you are dealing with a subject as sensitive as health, is how we survive. That is how it should be.

I say with pride that the medicines and treatments America’s pharmaceutical companies make are some of the most important and technologically advanced in the world today.

But I also say with sadness that too many patients and health care providers have lost trust in this industry. Without that trust we will not long be able to fend-off the interference of misguided policy makers and regulators who believe in government solutions to every health care problem.

Nothing highlights the work we have to do like the public debates now swirling around Direct to Consumer advertising (DTC).

Though DTC advertising has been proven to be very effective in raising patient awareness of disease and treatment options, it is also been a lightning rod for debate. Many in the public say they are bewildered by television ads that seem to talk about problems they don’t have or include messages that may not be appropriate for programs that children are watching.

Some doctors – already under enormous time pressures – complain they are besieged by patients asking questions about new medicines that the doctor feels unprepared to answer. And, there are also understandable concerns about whether DTC advertising helps patients understand not just a new medicine’s benefits but also its risks.
But this is one of the great things about the free market system. If you don’t listen to the public, you won’t be in business for long. The free market makes it possible for businesses willing and able to listen and learn to take quick and effective steps to better meet public needs and expectations.

America’s pharmaceutical companies have heard the concerns and recognize our obligation to act. It is an obligation that comes not only out of self-interest, but also out of the profound understanding that our business – the business of health -- is unlike any other business.

We also understand that informed, educated patients make the best patients. We can help improve the lives and options available to patients with the power of information.

That is why I am announcing tonight that PhRMA’s Board of Directors has adopted innovative and comprehensive voluntary “Guiding Principles” for direct-to-patient advertising and information.

Our goals are simple and straight-forward. We have long known that DTC communications – particularly television advertising – is a powerful tool for reaching and educating millions of people. As companies responsible for developing new and innovative medicines, we want patients and consumers to talk to their physicians about the medicines that may help them. We want them to have the information they need to improve their health. We also want them to better understand a medicine’s potential risks and side-effects.

DTC advertising of such important and powerful products as prescription drugs should and can be responsibly designed to achieve these goals and to encourage the appropriate use of these products.

PhRMA member companies already take their responsibility to fully comply with Food and Drug Administration (FDA) advertising regulations very seriously. Our advertising is already required to be accurate and not misleading; it can only make claims supported by substantial evidence; it must reflect the balance between risks and benefits; and it must be consistent with FDA approved labeling.

But we believe that we must, and can, go further. Patients and doctors expect us to do more than simply meet our legal obligations. More importantly, we know we can deliver messages that fundamentally educate patients and consumers and encourage them to seek guidance from their health care professionals. If we do our job right it will make the FDA’s job easier.

The Guiding Principles I am announcing tonight embrace patient education as the vital heart of our companies’ DTC communications efforts.

This means that DTC communications designed to market a medicine should also responsibly educate patients about a medicine and when it may be prescribed.

DTC television and print advertising should include useful information about other health care options for an advertised condition – like appropriate diet and lifestyle.

DTC advertising should also foster responsible communications between patients and doctors to help the patient achieve better health and a better appreciation of a medicine’s known benefits and risks.

Companies should spend appropriate time educating doctors about a new medicine before it is advertising it to patients. That way doctors will be prepared to discuss the appropriateness of a medicine with a patient.

Companies that sign-on to these Guiding Principles will submit all new DTC television advertisements to the FDA before airing them and companies are encouraged to promote health and disease awareness in their ads as well as to include information about how the uninsured and underinsured can get help getting the medicines the need.

In addition – and this is crucial – signatory companies are committed to establishing their own internal processes to ensure compliance with the guiding principles and to broadly distribute them internally and to advertisers. And, signatory companies commit to make public their intentions to comply with these principles.

For its part, PhRMA is establishing an accountability office to take all comments from the general public and health care professionals about signatory company’s DTC ads. PhRMA will provide the comments on compliance with the principles to signatory companies and it will also periodically issue reports to the FDA and the public about these comments and how signatory companies have responded.

The principles will go into effect in January 2006. One year after the effective date, the PhRMA accountability office will choose an independent panel to review that year’s reports. The panel will also track industry trends as they relate to the principles and make recommendations in accordance with the principles.

Again, the aggressive, positive steps we are taking to encourage meaningful direct to consumer education come out of the pharmaceutical industry’s renewed commitment to putting patients first and viewing all of our actions through the eyes of patients.

Proud as we are of these Guiding Principles, however, they are not an isolated public relations campaign. They are part of a larger effort that America’s pharmaceutical companies are taking to inspire public trust and to focus public attention on the real enemy in the health care battle – disease.

For example, we know that all of the innovative great medicines and treatments created by America’s pharmaceutical companies are useless if those who need them can’t get them. We also all know that a major source of public frustration and anger with our health care system is the fear that too many patients have that the miracle medicines they need won’t be there when they need them. They believe in our life-saving products but they worry that in order to save their lives they will have to bankrupt themselves or their children.

We can, and are, working hard to ease some of these worries.

For decades, PhRMA member companies have helped millions of patients with financial need get their medicines. Unfortunately, we just haven’t talked about it much – even though it is billions of dollars worth of medicine.

Well, we’re talking about it now. In fact, we’re down-right passionate about it. In April, we launched a new hotline for the Partnership for Prescription Assistance (PPA) to match uninsured and underinsured Americans with hundreds of private and public patient assistance programs. There are up to 400 programs, 150 of which are sponsored by PhRMA member companies. More than 1,200 different types of brand-name medicines are available from these programs for free or at a discount depending on financial need or insurance coverage. These programs also cover a wide array of generic drugs.

More than 60 national and local organizations are partnering with us to help tell patients about these programs include health care and patient advocates, medical professional societies, retail pharmacies, charities and community organization. We’re getting help from the National Grange, the United Way campaign, Easter Seals, the NAACP, the National Urban League and many, many more.

We are proud to work with them to promote PPA and to get information about the program into the hands of physicians and patients. Since April, nearly 700,000 patients have been matched to programs that can provide free or near free medicines. And we expect this number to keep growing.

However, as great as our PPA program is, it will never be enough to give everyone peace of mind that their medicines will be available when they need them.

That is why we want to work closely with ALEC, and all state legislatures and legislators to make sure that the new Medicare prescription drug benefit is a success. The prescription drug benefit will help seniors and the disabled get both the medicines they need and peace of mind. Our failure to act now and make this benefit a success will bring us one step closer to socialized medicine where bureaucrats – not doctors and patients – make critical health care decisions.

The new prescription drug benefit can help change that and ease those fears. It provides important savings on the cost of medicines, catastrophic protections and new preventive benefits.

This means that Medicare beneficiaries will get better health care and improved access. It means that seniors – for the first time – will have real choices among competing private plans. It also means that many seniors may stay healthier longer and may make fewer demands on the most expensive parts of our health care system – such as hospitalization, surgeries and long-term care.

In short, for many, it will mean the end of the worry over whether to take a medicine or pay for food, housing or other necessities of life. Patients will get the medicines they need and the medicines their doctors want them to have.
While our DTC Guiding Principles, PPA programs and the new Medicare prescription drug benefits are important, there is more that we must do.

When you view the world through the eyes and needs of patients, making sure that patients get the medicines they need is not enough. You also have to make sure that medicines and health care are available. This means working to eliminate impediments that can keep patients from their doctors or that stifle innovation and the development of new medicines and treatments.

Frivolous lawsuits and outrageous punitive awards are a prime example of such an impediment.

This is why PhRMA looks forward to continuing working with ALEC and state legislators across the country on real, substantive liability reform. Together, we have won some important victories.

In South Carolina – after a lot of hard work by the South Carolinians for Tort Reform and other groups – the state passed two major bills on medical malpractice and general tort reform. The medical malpractice reform bill capped non-economic damages, and the general tort reform included joint and several liability thresholds of 50%, venue reform, frivolous lawsuit sanctions and a reduction in the statue of repose.

In Georgia, a coalition came together to pass a comprehensive reform bill that includes venue reform, caps on non-economic damages in medical malpractice cases and the abolition of joint and several liability. The legislation also mandated that experts' affidavits are required to file a malpractice case.

We worked hard in Wyoming to pass HR 83 – the Medical Review Panel Act. It creates a medical review panel to stop frivolous lawsuits.

And, in Washington State, we are working with groups across the state in support of ballot initiative I-336 – which includes non-economic injury and attorney’s fee caps, periodic payment of damages, and eliminating joint and several liability in medical malpractice cases, making it several only.

There is so much more to do, yet I am confident that together we can – and we are – building a health care system in this country that puts patients first and creates an environment that inspires new, creative solutions to fighting disease. We also need to reward those who take the risks and develop innovative new cures and treatments.
As you can see, I am both a firm believer in the power of the free market and I have high expectations and hopes for the positive role America’s pharmaceutical companies play in the life and health of our great country.

My hopes and expectations are born of hard experience – experience that I share with millions of other Americans -- and probably with quite a few of you here tonight.

I am somebody who wouldn’t be walking around today if it wasn’t for ground-breaking pharmaceutical research. And I’m just one in 10 million – 10 million people -- alive today because of breakthrough treatments we didn’t have just a few short years ago.

My first-hand exposure to the value of drug research started one day in a New York hotel room. I suddenly started bleeding uncontrollably – losing about half my blood. I was suddenly in a battle for my life with intestinal cancer.
There’s a surgical treatment, but it’s a tough one: They have to rip all your parts out, put them back in, and hope it works. It was so tough that I asked my parish priest to come in to administer the last rites. I was such a bad case I ended up having to cheer him up.

Soon after surgery I met with my doctor at MD Anderson Cancer Center at the University of Texas – an excellent institution. But for me it was the site of bad news. “Billy,” he said, “you’ve got a lymph node in there and it’s cancerous.” Then he gave me the worse news. They didn’t have a protocol for dealing with it. They couldn’t go back in there, not without undoing all of the surgery. 

That was about as low as I had ever felt in my life – and I don’t mind telling you, about as scared. The first thing you think about is your family, and what you’re going to tell them. The next thing, you look for a life raft – for them as well as yourself. My doctor held one out. He explained there was this brand new drug called Avastin, and it might cure me. But it might also reverse the effect of the surgery. The drug had gone through three rounds of clinical trials involving thousands of people – like all FDA-approved drugs – but I would be the first person to take it post-surgery. It could cure me … or kill me.

I made the decision with my doctor … with my family – and not with any government official. I took the risk of going with a new drug on the market – and every day since I have thanked God I did. But make no mistake: If the cancer had gotten started before the FDA got done with Avastin – I wouldn’t be here today.

I thanked a few others, too. I got a chance to do something most people who benefit from medication don’t get to do – thank the people who developed it. Soon after I moved into this job, I paid a visit to the Roche plant in Nutley, New Jersey, and expressed my enormous gratitude to the people who saved my life. I looked them in the eye, and I shook their hands. And I can tell you – their commitment to saving lives is beyond question.

In conclusion, Irving Kristol was famous for giving two cheers to capitalism. Well, I’ll go him one better. But my three cheers for the free market come along with an asterisk – there’s a difference between offering cheers and being a cheerleader. Because if we’re going to seek the benefits of a free market, we must also meet the social obligations that come with it.

How do we fulfill it?

We are making a bold start with our DTC Guiding Principles, our PPA initiative and our work to make sure that seniors and disabled Americans take full advantage of the Medicare prescription drug plan, we’ve made a great start at putting patients at the heart of everything we do.

We also know that we cannot just talk about how we research and develop the medicines that matter to you and your families and not help make sure those drugs are actually available. It’s as simple as that.

Finally, I want to leave you tonight with three thoughts – three areas where those of us who believe in the power of the marketplace can work to make our case … and win converts to our cause:

One -- as I have said so many times we have to evaluate this issue from the patient’s point of view. They need access and affordability – but they also need innovation. They don’t just need the most affordable medication – they need the most effective medication. As you know here at ALEC, we can’t expect to eliminate the pull of incentive and expect the push for innovation to remain. Markets just don’t work that way.

Two, let us not fool ourselves into thinking that governments can control price without controlling a lot of other things – including choice, availability, and innovation. It does no long-term good to pass a law that forces an artificially low price, if all that does is dry up the pipeline for new and better medicines.
Three, when looking at drugs, let’s not become so fearful of risk that it clouds our minds to reward – the reward of a drug that can save lives and ease pain.

Friends, America has taken the lead in creating life-saving drugs for good reason. We are committed to life, we are supportive of innovation, and we have confidence in individuals and in the market system. Those are big assets – big advantages that will help us develop and produce the medications that will continue to make life longer, better and happier for generations to come.