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It's In His DNA

Barack Obama may represent the first President who understands personalized medicine at more than a conceptual level.

BY DANIEL S. LEVINE
The Journal of Life Sciences

Several years ago, a friend of Robert Wells told him about a scientist who was conducting cutting-edge genetics research in the heart of Amish country. At the time, Wells was vice president for corporate affairs and international markets for the genetics tools company Affymetrix, which became connected with the researcher D. Holmes Morton.

Wells related this story earlier this week at The Annual Burrill Personalized Medicine Meeting, which is put on each year by Burrill & Company, the owner of The Journal of Life Sciences. The work, notes Wells, caught the attention of a reporter at The New York Times, and when the article appeared in November 2005, it caught the attention of a young senator from Illinois, who approached his health policy advisor and told her he wanted to do something to foster such work.

The result of that was Senator Barack Obama’s proposed Genomics and Personalized Medicine Act of 2007. (The comments he made when he introduced the legislation can be read on TJOLS. Though the bill did not make its way through the legislative process, Wells, who is a co-founder of the Washington, D.C.-based government relations firm HealthFutures, expects the legislation will be reintroduced by another senator after Obama takes office as President.

Wells told the story to emphasize a point that has him and others involved in the area of personalized medicine excited about the in coming commander-in-chief. “We have elected, from our own parochial perspective, the first President who understands personalized medicine at more than just a conceptual level,” said Wells. “And we’ve elected probably the first president who had a parent pass away from cancer at a very young age. And we elected a president who’s bringing with him a team of people who know these issues well.”

Wells said under normal times, this would put the “wind at your back,” but he acknowledges these are not normal times. The new administration comes into office with a long list of problems to solve, many of which are both complex and demanding. But, he adds, the new administration is “predisposed to understanding that innovation and new technologies and new approaches are key to changing this healthcare system.”

The transformative role personalized medicine can play in reshaping healthcare and addressing the problems caused by our current practice of medicine has not been lost on some members of the Bush administration. Both U.S. Department of Health and Human Services Secretary Mike Leavitt and National Institutes of Health Director Elias Zerhouni have been big proponents of it, and the FDA has pushed along its Critical Path initiative.

“There’s become this near perfect storm of people of various touch points along the policy chain that have really understood that the future is about not your grandfather's concept of medicine, but something that is very new and very different and very oriented to where the future is,” said Wells. “There’s not one way to do it. You can’t just wave a magic wand and say there is one way of doing this. It goes across all of the agencies, across the Congress, across, as I have said, multiple touch points, but all along that chain we see it happening. The challenge for the new administration is going to be to try and harness that energy to some degree and try to coordinate it.”

Let’s hope that it’s not only a move away from your grandfather’s concept of medicine, but his concept of presidents as well.

Hits and Misses

An analysis of pharma deals shows certain types are better predictors of success than others.

DANIEL S. LEVINE
The Journal Of Life Sciences

Michael Lewis’ Moneyball showed that major league baseball teams often focus on the wrong stats or rely too much on subjective measures in deciding what ballplayers would be valuable to have on their team. A guy who can belt one out of the park may seem a lot sexier than a selective hitter who walks a lot, but is he a better value?

A new study from the consulting firm Accenture tries to bring a little Billy Beane wisdom to pharmaceutical deal making. It pores over pharmaceutical deals to see whether there are good indicators of what will boost shareholder value and the likelihood that a drug acquired, licensed, or collaborated upon results in U.S. Food and Drug Administration approval.

The information is of no small consequence. Pharmaceutical companies have been aggressively making deals to fill gaps in their pipelines and combat lost revenue from competition from generics. But few studies have looked at what kinds of deals actually increase shareholder value or lead to approved products.

Some consultants have in recent years produced reports that suggested that in a period where there is great pressure to do deals, the most successful companies would be the ones able to buy a particular asset or company and move quickly to absorb it. By contrast, collaborations were seen as less attractive because of the complexity of such arrangements and the high cost of managing the relationship through the entire life of the deal. But Accenture’s new report “Making the Right Bets” finds collaborative deals actually have greater success at raising shareholder value (the change in price from five days prior to the deal’s announcement to five days after) and a greater chance of leading to an FDA approval.

“If a company wants to hold on to an asset, that suggests they have confidence in the asset—sure, but that’s not the way deals have been playing out in the past,” said Elizabeth Coulton, partner with the products strategy practice of Accenture in Atlanta. “It’s the moneyball analogy.”

Coulton points out that baseball scouts used to think that players who get walks weren’t valuable, but now with moneyball, the baseball establishment is coming to realize that people who walk a lot are some of the most valuable in players in the league.

“That’s the same way we’re seeing deals play out in the study,” she said. “More collaborative deals are more successful with respect to shareholder value and FDA approval.”

Accenture began by looking at more than 18,000 deals between 1997 and 2006. It then pared that list down to 355 by eliminating deals where the phase of development was ambiguous, the compounds were destined for commercialization in non-U.S. markets, the drugs involved were already approved, or the deals were for manufacturing or contract research organization services.

There were other surprises. The study showed that while the market does reward shareholders for deals struck in phase III, the greater the market response to a deal, the less likely the drug involved will win FDA approval.

“The truth is that the market reaction for phase III deals is inconsistent with the probability of success with the FDA,” said Coulton. “With phase II, the greater shareholder return, the greater the probability of success with the FDA.”

Coulton thinks the reason for that is that phase II deals were more likely than phase III deals to be collaborations.

Overall, Accenture found that the market rewards buyers of phase I and phase III drug deals, collaborations, and small molecule deals. With in disease areas, the market rewards phase I blood and oncology deals, and phase II and III allergy, pain and infection drug deals. It penalizes the buyer for simple licensing deals.

For sellers, the market rewards deals involving biologic molecules. The market is penalizing companies for sales of phase I and phase II allergy, pain and infection drugs, as well as blood and oncology drugs. It also penalizes sellers of phase I kidney, liver, and metabolic disease drugs.

Other findings were not considered statistically significant.

“For pharmaceutical companies now looking to fill revenue gaps in the near-term and pipeline gaps perpetually,” Coulton said, “this study—an analytical approach—can inform the types of deals companies are looking to do rather than relying on their deal scouting teams and their due diligence.”

Dishonor Roll

U.S. health system’s grade knocked down to a D.

BY ERIC WAHLGREN
The Journal Of Life Sciences

Whether it’s John or Barack, we’ll have our work cut out for us when it comes to fixing healthcare.

A new study from The Commonwealth Fund, a foundation focused on improving healthcare access, quality, and efficiency, downgrades the U.S. health system to a score of 65 out of 100. That compares to a 67 in 2006. At the public high school I attended at least, such results would be akin to slipping from a “D+” to “D” student—not exactly the kind of performance we want from the odd medical conglomerate we’ve built over the years to keep us alive and healthy.

The study compares national averages in five dimensions—healthcare outcomes, quality, access, efficiency, and equity—with U.S. and international performance benchmarks. Of greatest concern, says The Commonwealth Fund, is that access to health care has “significantly declined” in the last few years. As of 2007, some 42 percent of American adults (75 million adults) were either uninsured or underinsured during the year, up from 35 percent in 2003. “Overall, [the study] finds the U.S. is losing ground in providing access to care and has uneven healthcare quality,” group says.

Indeed, the report really makes the system out to be a real loser. The U.S. now is last out of 19 countries, after France, Japan, Ireland, and Portugal, among others, in terms of mortality that could be prevented through timely and effective healthcare. Two years ago, it was 15 on the list. That’s of course despite the fact that the U.S. is the world’s drunken sailor when it comes to healthcare spending, forking out twice per capita what other major industrialized countries spend on healthcare, according to the report.

Part of the explanation for the spending paradox is that the U.S. system gets an “F” (53) for efficiency when evaluated for the number of avoidable hospitalizations, the low use of information technology, and other factors. In the U.S., patients were up to four times more likely to have duplicate tests or medical records than in other countries. “The U.S. currently under-invests in the capacity of the health system to innovate and improve,” The Commonwealth Fund says.

There are a few brighter spots. The rates of control of high blood pressure among American adults increased to 41 percent in 2003-2004 from 31 percent in 1999-2000, according to the report. Control rates for diabetes rose to 88 percent from 79 percent in the same period, the group said.

Despite all the study’s doom and gloom, the U.S. remains a remarkable place for medical talent and innovation. Even if the system as a whole is a mess, the individual institutions and medical professionals that make up the system are often the envy of the world. What the system urgently needs, The Commonwealth Fund says, is national leadership “to yield greater value for the resources devoted to healthcare.” But with a war, mortgage crisis, global warming, and creeping inflation among the other problems facing whoever is the next president, helping healthcare get its grades up will be no cinch.

Whether The Couric Effect Is Real, It’s Not Enough

CDC says despite improvements colorectal cancer screening rate remain too low.

DANIEL S. LEVINE
The Journal of Life Sciences

I am not a regular viewer of morning television, but circumstances were such that early one day in March 2000, I watched Katie Couric get a colonoscopy on the Today show. Perhaps it is chance viewings like this that explains why I am not a regular viewer of morning television.

Couric, who lost her 42-year-old husband Jay Monahan to colon cancer, was a woman with a cause. She apparently was so successful at raising awareness about the importance of getting screened for colon cancer that researchers dubbed the 20 percent increase in colonoscopy rates in the months that followed the broadcast “The Katie Couric effect.”

But that clearly has not been enough. Researchers at The Centers for Disease Control and Prevention report in the July 2008 issue of the journal Cancer Epidemiology, Biomarkers and Prevention that only about half of U.S. men and women 50 and older receive the recommended tests. The CDC conducted a National Health Interview Survey in 2005. Although this was an improvement over the 43 percent of screened individuals reported in 2000, it is still far from optimal, researchers said.

CDC epidemiologist Jean Shapiro believes a major problem is insurance coverage. Among people without health insurance, researchers found the rate of colorectal cancer screening was 24.1 percent, compared to more than 50 percent of insured Americans, depending on the type of insurance. Among patients without a usual source of health care, the screening rate was 24.7 percent compared to 51.9 percent of patients with a usual source of healthcare.

“If we can increase the number of people who have health care coverage, we should be able to increase colorectal cancer screening rates,” said Shapiro.

As for the Katie Couric effect, Shapiro says the increase in colorectal cancer screening rates observed from 2000 to 2005 may have been due in part to increased media coverage of the importance of colonoscopy. However, Shapiro adds, the increase was probably also due to the fact that in 2001, Medicare expanded its coverage for colonoscopy screenings to a wider range of patients.