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A disappointing end to a disappointing decade
January 2010
by Peter T. Kissinger  |  Email the author
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We just left behind both a year and a decade, and pundits can't resist opining on what happened. For many of us, the kindest thought is that our expectations were far from met. When we woke up on Jan. 1, 2000, we were delighted to find out that the Y2K predictions of software-driven doom did not occur. We still had power. Our computer networks still functioned. We had few good days early in this millennium, but we've got 990 years to make up for it.  
 
What went very badly wrong: An acceleration of Islam-derived terrorism in frequency, scale and geographic distribution that shows no signs of abating; a dot-com crisis on Wall Street; financial shenanigans at Enron, Tyco and Arthur Anderson that precipitated Sarbanes-Oxley legislation, which largely destroyed the IPO market for venture-backed firms in the USA; a war in Afghanistan; a war in Iraq; squabbles in Chechnya, Darfur, Georgia and Mexico; a global crisis in banking; revelations of various Ponzi schemes, Madoff being the largest; a total collapse of civility in Washington, D.C. as evidenced by much talking, but no listening; governors and athletes displayed the face of morality and ethics, then showed us an opposite reality as families were destroyed by the peccadilloes of bad boys.   
 
What did not go very right in our industry: Genomics and proteomics did not meet their heightened expectations; pharma R&D sites were closed by the dozens and layoffs substantially exceeded hiring; megamergers demonstrated their lack of productivity for both R&D and shareholders; recalls of recently approved drugs were made worse by accusations of cover-ups, conflicts in clinical trials management and documentation of trials including a lack of transparency, exposure of e-mails and faked, improperly attributed publications; lawsuits and settlements with pharma over improper marketing practices, federally and state-by-state, exceeded $3 billion in 2009 alone. In the first decade of the millennium, pharma legal settlements and fines totaled approximately $10 billion, a number that could have funded much research on unmet medical needs.  
 
Science is properly under attack: Along with the polarization and lack of balanced debate in politics, science has adapted the same "if you are not with us, you are against us" stance. Predictions of the future related to stem cells, climate change, various viral pandemic threats, multiple drug targets, systems biology and pharmacogenomics are among those where loud zealots were countered by loud skeptics. The fervor often took on evangelical elements, where evidence-based science was discarded in favor of belief, as in, "I believe in global warming, and if you do not, you are a fool." Science is based on evidence that is to be challenged by more evidence and new theory. When we mix science and marketing, whether to get grants, raise equity or to sell product, we are asking for real trouble—and boy, did we receive it in the last decade. The public and the political class doubt us more than ever. We are perhaps thus regulating ourselves into oblivion, or at least less efficiency.   
 
Professors spend more than 35 percent of their time searching for elusive grant funding and complying with grant regulations. The number of submissions and the cost of research goes up faster than the available resources, and thus, the yield goes down. We talk translational research, but have made the cost of doing it unsustainable and put the rewards for doing it into a tailspin.
 
We likewise regulated the IPO market for small companies right out of existence. Could it be that we now lose more from regulating away risk then we would lose from those who cheat and steal? Because of the palpable and visible abuses that we all have felt, the incentives for innovation are being sapped away by government. Why else would dozens of pharma R&D centers be shuttered over the last decade, with thousands  of scientists furloughed? Where is the appropriate balance? I have no idea, but I'm worried. If you are too, can we find a solution? 
 
While pharma was once a comfortable, if provincial, haven for a very satisfactory lifetime employment, it is now a home for short-term, contract employees and much turmoil. Schumpeter's "creative destruction" is accelerating. Change we can believe in has become change we have to live with and make work. We have 90 years left to make the 21st century into something really good. We must try.  
 
The good news is that weak cycles are followed by strong ones. We've learned that pushing money around without generating wealth is not sustainable. The wealth of society comes from adding value with innovative products and services. This new decade will see the $1,000 genome. Personalized medicine will expand from its rudimentary position today as more biomarkers are validated and assay costs come down. Pharmaceutical and diagnostics companies will partner more.    
 
During the next decade, the general public will finally become aware of the incredible work already accomplished by reproductive biologists funded by NIH/NCRR at the National Swine Resource and Research Center (NSRRC), which has created pigs that have human-compatible livers, retinas and other organs. The culmination of this effort will make this source of tissue available for human xenotransplantation, relieving the backlog of critically-ill people waiting for human-derived replacement organs and even broaching the possibility of personalized organs based on the patient's own DNA and grown in the pig, which would require no immunosuppressive drug therapy.
 
Swine-derived products are already approved to treat diabetic ulcers, repair hernias and even the dural membrane of the brain. Less far reaching, but already coming into place, are genetic characterization of cancer biopsy tissue, molecular imaging with mass spectrometry and even culturing cancer cells ex vivo to explore which drug is most likely to be effective for an individual patient. The debate over cost, risk and rationing care will continue, but medical science will nonetheless advance.  
 
The networking of discovery companies, contract research organizations, contract manufacturing organizations and traditional pharma will accelerate. Universities will continue to be pushed to manage larger projects across disciplines, and a few will learn that efficiency counts. We will see near-patient mass spectrometers. We will drive electric cars and see a rebirth of nuclear power with further acceleration of wind and solar power. It's a great new decade for science and engineering. We're ready.  
 
Peter Kissinger is chairman emeritus of BASi, CEO of Prosolia in Indianapolis and a professor of chemistry at Purdue University.

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