We just left behind both a year and a decade, and punditscan't resist opining on what happened. For many of us, the kindest thought isthat our expectations were far from met. When we woke up on Jan. 1, 2000, wewere delighted to find out that the Y2K predictions of software-driven doom didnot occur. We still had power. Our computer networks still functioned. We hadfew good days early in this millennium, but we've got 990 years to make up forit.
What went very badly wrong: An acceleration of Islam-derivedterrorism in frequency, scale and geographic distribution that shows no signsof abating; a dot-com crisis on Wall Street; financial shenanigans at Enron,Tyco and Arthur Anderson that precipitated Sarbanes-Oxley legislation, whichlargely destroyed the IPO market for venture-backed firms in the USA; a war inAfghanistan; a war in Iraq; squabbles in Chechnya, Darfur, Georgia and Mexico;a global crisis in banking; revelations of various Ponzi schemes, Madoff beingthe largest; a total collapse of civility in Washington, D.C. as evidenced bymuch talking, but no listening; governors and athletes displayed the face ofmorality and ethics, then showed us an opposite reality as families weredestroyed by the peccadilloes of bad boys.
What did not go very right in our industry: Genomics andproteomics did not meet their heightened expectations; pharma R&D siteswere closed by the dozens and layoffs substantially exceeded hiring;megamergers demonstrated their lack of productivity for both R&D andshareholders; recalls of recently approved drugs were made worse by accusationsof cover-ups, conflicts in clinical trials management and documentation oftrials including a lack of transparency, exposure of e-mails and faked,improperly attributed publications; lawsuits and settlements with pharma overimproper marketing practices, federally and state-by-state, exceeded $3 billionin 2009 alone. In the first decade of the millennium, pharma legal settlementsand fines totaled approximately $10 billion, a number that could have fundedmuch research on unmet medical needs.
Science is properly under attack: Along with thepolarization and lack of balanced debate in politics, science has adapted thesame "if you are not with us, you are against us" stance. Predictions of thefuture related to stem cells, climate change, various viral pandemic threats,multiple drug targets, systems biology and pharmacogenomics are among thosewhere loud zealots were countered by loud skeptics. The fervor often took onevangelical elements, where evidence-based science was discarded in favor ofbelief, as in, "I believe in global warming, and if you do not, you are afool." Science is based on evidence that is to be challenged by more evidenceand new theory. When we mix science and marketing, whether to get grants, raiseequity or to sell product, we are asking for real trouble—and boy, did wereceive it in the last decade. The public and the political class doubt us morethan ever. We are perhaps thus regulating ourselves into oblivion, or at leastless efficiency.
Professors spend more than 35 percent of their timesearching for elusive grant funding and complying with grant regulations. Thenumber of submissions and the cost of research goes up faster than theavailable resources, and thus, the yield goes down. We talk translationalresearch, but have made the cost of doing it unsustainable and put the rewardsfor doing it into a tailspin.
We likewise regulated the IPO market for small companiesright out of existence. Could it be that we now lose more from regulating awayrisk then we would lose from those who cheat and steal? Because of the palpableand visible abuses that we all have felt, the incentives for innovation arebeing sapped away by government. Why else would dozens of pharma R&Dcenters be shuttered over the last decade, with thousands of scientists furloughed? Where is theappropriate balance? I have no idea, but I'm worried. If you are too, can wefind a solution?
While pharma was once a comfortable, if provincial, havenfor a very satisfactory lifetime employment, it is now a home for short-term,contract employees and much turmoil. Schumpeter's "creative destruction" isaccelerating. Change we can believe in has become change we have to live withand make work. We have 90 years left to make the 21st century into somethingreally good. We must try.
The good news is that weak cycles are followed by strongones. We've learned that pushing money around without generating wealth is notsustainable. The wealth of society comes from adding value with innovativeproducts and services. This new decade will see the $1,000 genome. Personalizedmedicine will expand from its rudimentary position today as more biomarkers arevalidated and assay costs come down. Pharmaceutical and diagnostics companieswill partner more.
During the next decade, the general public will finally becomeaware of the incredible work already accomplished by reproductive biologistsfunded 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 thissource of tissue available for human xenotransplantation, relieving the backlogof critically-ill people waiting for human-derived replacement organs and evenbroaching the possibility of personalized organs based on the patient's own DNAand grown in the pig, which would require no immunosuppressive drug therapy.
Swine-derived products are already approved to treat diabetic ulcers, repairhernias and even the dural membrane of the brain. Less far reaching, butalready coming into place, are genetic characterization of cancer biopsytissue, molecular imaging with mass spectrometry and even culturing cancercells ex vivo to explore which drug ismost likely to be effective for an individual patient. The debate over cost,risk and rationing care will continue, but medical science will nonethelessadvance.
The networking of discovery companies, contract researchorganizations, contract manufacturing organizations and traditional pharma willaccelerate. Universities will continue to be pushed to manage larger projectsacross disciplines, and a few will learn that efficiency counts. We will seenear-patient mass spectrometers. We will drive electric cars and see a rebirthof nuclear power with further acceleration of wind and solar power. It's agreat new decade for science and engineering. We're ready.