Saturday, April 14, 2012

Drug Innovation 2: Sustaining Innovation via Competition

I noticed today on twitter a number of messages on the annual meeting of the Pharmaceutical Research and Manufacturers of America (PhRMA) Annual Meeting in Boston, so I checked their website,

Saw this photo there, good theme. Medicines, whether innovator or generics, so long as they are the real ones (ie, non-fake, non-substandard) and have passed stringent requirements for safety and efficacy by the drug regulatory agencies, and are regularly monitored via pharmaco-vigilance, should be useful to people and communities.

There should be no debate on the delineation of service and usefulness between innovator drugs and generic drugs because most, if not all, generic manufacturers recognize the high risks and huge costs of inventing new medicines against various diseases -- old, emerging, mutating/evolving new ones. Thus, intellectual property rights (IPR) schemes like patents are generally recognized.

But there are certain sectors and ideological interests, political groups and politician interests, that do not want to respect IPR schemes by which innovator companies abide by existing rules. And various debates and new government regulations that tend to demonize innovator companies while silently praising their newly invented drugs have cropped up.

I believe that patients and public interest will be maximized if we have more, not less, innovator companies around, competing with each other in giving us more powerful treatment and medications. After their new drugs' patent have expired, a new round of competition, more fierce competition in fact, comes in with the entry of many generic manufacturers. And public interest is further advanced with more choices, more options for patients and health professionals.

Anyway, I am posting below four short articles from the PhRMA website that are related to medicine innovation and their Boston meeting, below. Enjoy.

Opportunities Abound, Say Viehbacher and Lechleiter

In their moderated discussion this morning, outgoing PhRMA Chairman Christopher Viehbacher (from Sanofi) and incoming PhRMA Chairman John Lechleiter (from Eli Lilly and Company) discussed ways that companies can maximize different types of opportunities.
Of course, in the biopharmaceutical sector, science is key. As Viechbacher said, the promise of the research happening now is built on knowledge we’ve developed in the past: “Most of our success in the 1990s was based on targets that came out of research in the1970s and 1980s. Now we’ve got new targets coming out of NIH and it’s opening up opportunities everywhere. If we can come up with new models, we can capitalize on these opportunities.”
Lechleiter concurred: “There’s a sense in the room today of much more optimism than pessimism. People critical of how much R&D we’ve spent in a last decade with what they call diminished returns are looking in the rear-view mirror. I’m encouraged by the way that large companies, small companies, government and academia can work together.”
He also highlighted the President’s Council of Advisors on Science and Technology, which is working with many PhRMA members as well as other stakeholders, as an opportunity to improve the way that we get medicines to patients.
Both agreed that increased collaboration with patients can also help open doors to both research and access, as well.
As Viehbacher said generally, but significantly: “There are enough opportunities to go around.”

Inspiration for Advancing Medical Innovation

This is a guest post from John C. Lechleiter, PhD, who is Chairman, President and CEO of Eli Lilly and Company. Starting today, Mr. Lechleiter is also the Chairman of the Board of Directors of PhRMA.
The biopharmaceutical industry is all about medical innovation. It’s our lifeblood. Yet, too often we talk about medical innovation without making it hit home for people outside the industry.
Rewind to three decades ago, when HIV first became a major public health concern. Not only were we on the verge of a human disaster, but public health officials worried that we wouldn’t have enough hospitals to treat an approaching avalanche of AIDS patients. Thanks to medical innovation, it didn’t happen (AIDS deaths have dropped by 70 percent since 1995). Similarly, thanks to a two-thirds drop in the death rate from coronary heart disease in the U.S. since the 1960s, 1 million more Americans are alive each year. Anti-hypertensive treatments alone account for 800,000 fewer hospitalizations each year – and 86,000 fewer deaths.
These are impressive and important success stories, but our work is far from over. Fast-forward to today: too many people still die from cancer. Diabetes is growing at epidemic rates. And Alzheimer’s disease represents an imminent crisis. The Alzheimer’s Association says that by 2050, more than 13 million Americans will have the disease – at a cost of more than $1 trillion annually – unless better treatments are found.
Sustaining our advances in medical innovation is priority one -- and it’s incumbent upon all those in our industry to make it happen. The ongoing revolution in the life sciences, with all its promise, will mean little without public policies that foster innovation. We have to get our story out in compelling and meaningful ways. Our industry must also continue to build trust with our various stakeholders. By telling the stories of our mothers and brothers and children who’ve been saved by new medical treatments – and by upholding the highest standards of integrity and ethical behavior in everything we do – the fruits of our efforts can be fully realized.
I’m proud to chair PhRMA’s board for the next 12 months – and it’s an honor to be part of an industry that focuses on saving lives. But let’s not look at our past successes as some sort of historical footnote. Let’s use them as inspiration to find new innovative treatments for the next generation of patients. They’re waiting.

What April 12 Means to PhRMA’s Chairman

New PhRMA Chairman John Lechleiter, President and CEO of Eli Lilly and Company, continued the vein of optimism in his comments this morning. He urged those of us in the room “to stand up for policies that support innovation, to continue to build trust with our stakeholders, and to get our powerful story out.”
We must do so, he said, to continue the “heroic work of healing and saving lives well into the future.”
Yesterday’s date, April 12, is “famous in the annals of innovation.” On that date in 1961, the first human flew in space. Twenty years later to the date was the launch of the space shuttle program. Around the world, these moments in space exploration have been held up as examples of true innovation.
However, Lechleiter said, there is a much more important April 12. On that date in 1955, it was announced that Jonas Salk’s polio vaccine worked: “That vaccine turned a disease that once horrified America into a memory, and over time would do so for most of the world.”
He added: “Medical innovation over the past century transformed the basic expectations of human life that had prevailed since the dawn of civilization.”
Lechleiter continued, discussing the overall value of prescription medicines. And he discussed medical need. And he discussed increases in generic utilization rates.
But after the last day and a half of conversation about innovation, collaboration and development, it feels good to focus on the aspirational, because all of us here in Boston certainly share that optimism: “I believe that the juxtaposition of new insights into human biology, coupled with the application of new tools and advancements in technology, has the potential to revolutionize our business more in the next ten years than in the past 50.”
He closed urging us all to “preserve the innovation that is at the heart of what we do and that people are counting on us for.”

PhRMA Member Companies Invested $49.5 Billion In Research and Development in 2011

2012 Industry Profile and Updated Chart Pack Resource Now Available
Washington, D.C. (April 12, 2012) — Investment in research and development by members of the Pharmaceutical Research and Manufacturers of America remained strong at $49.5 billion in 2011, as the sector adapts to meet the challenges of evolving science, a changing marketplace and a difficult economic environment.
Biopharmaceutical research companies are continuing to explore the possibilities associated with more targeted therapies and personalized medicines, and are building on the benefits associated with partnerships among experts throughout the research ecosystem.
These efforts are reflected in PhRMA’s new 2012 Industry Profile as well as an updated version of its informational chart pack resource, “Biopharmaceuticals in Perspective,” both released today. Both sets of materials are available for public use and are intended to provide  timely, relevant information about the biopharmaceutical research sector, which includes both pharmaceutical and biotechnology companies.
The 2011 R&D investment figures reflect the biopharmaceutical sector’s standing as America’s most research-intensive industry. According to a recent report by the National Science Board of the National Science Foundation, the U.S. biopharmaceutical sector accounts for the single largest share of all U.S. business R&D, representing nearly 20 percent of all domestic R&D funded by U.S. businesses. In the U.S., R&D expenditures among PhRMA members represented a remarkable 21.1 percent of domestic sales....

See also:
Drug Innovation 1: On Cancer, Bioequivalence and Clinical Trials, March 28, 2012
IPR and Medicines 16: Wikileaks and the Cheaper Medicines Law, November 08, 2011

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