Perhaps more so than most years to date, 2009 has repeatedly raised the specter of misdeeds in research -- both in academia and industry.
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New year's celebrations in Taipei Image: Wikimedia Commons |
With more and more academic research
funded by industry and few universities having consistent policies on how their researchers must report their financial ties, Senator Charles Grassley (R-IA) this year
continued his probe into researchers' and physicians' conflicts of interest. In response to the increasing pressure, the National Institutes of Health finally conceded that it may need to do some
conflict of interest monitoring of its own, rather than relying on voluntary reporting by researchers and their institutions. Meanwhile, top medical journals have adopted
a standard conflict-of-interest disclosure policy that probes deep into the financial and nonfinancial interests of authors publishing in their pages.
It's also been a boom year for lawsuits accusing companies of improprieties like misrepresenting data, pulling marketing tricks, and engaging in ghostwriting. Details from one such lawsuit, a civil suit filed in Australia against Merck and its withdrawn anti-inflammatory drug Vioxx, spurred
The Scientist to report that Merck and science publishing giant Elsevier
produced six fake journals between 2000 and 2005 -- publications sponsored by Merck without disclosure and made to look like peer-reviewed medical journals.
Adding to the uncertainty, the economy has also left its mark on the life sciences this year -- with mass lay-offs in the pharma industry,
trouble in
biotech, and extreme cost-saving measures in academia including
forced furloughs at universities across the country.
But apart from some turbulence, it's been a lively year for life science. Here's a month-by -month timeline of some key events affecting US life science in 2009:
January
The US Food and Drug Administration
approves the first-ever clinical trial of a human embryonic stem cell-based therapy on January 23. But not so fast with the kudos -- the FDA
placed a hold on the trial in August due to cysts that seemed to form in animals receiving the experimental treatment. The company says it's likely to resume the trial in 2010.
February
Congress on February 13
approves a $789 billion economic recovery bill, which includes a
$10.4 billion bolus for the NIH and $3 billion for the National Science Foundation. The bill led to a storm of activity to disburse the one-time boost, with about 20,000 researchers applying for 200 stimulus-funded NIH Challenge grants.
March
On March 9, US President Barack Obama
lifts restrictions on federal funding for embryonic stem cell research put into place by the previous administration. Obama charged the NIH with coming up with a new set of guidelines for determining which embryonic stem cell lines were ethically derived and approved for use. The new rules
appeared in draft form in April and
were finalized in July. Early this month, the
NIH announced the first 40
approved lines.
April
The
H1N1 influenza virus,
dubbed swine flu, makes its presence known in the US and around the world, with World Health Organization director-general Margaret Chan declaring swine flu a "public health emergency of international concern" on April 25.
May
Researchers in Japan create the first
transgenic primates able to pass on the transgenic DNA to their offspring.
June
A national faculty organization launches a
formal investigation into the mass termination of tenured and tenure-track professors at the University of Texas System and its Medical Branch in Galveston. The university had said last year's firings were justified on grounds of financial exigency in the wake of Hurricane Ike, but faculty members
appealed the action.
Officials in New York make a quiet announcement that the Empire State will allow women to be
paid for oocytes donated for research, becoming the first and only state to date to enact such a policy.
July
After much whispering in the rumor mill, geneticist Francis Collins, who directed the National Human Genome Research Institute until last year, is nominated on July 8 by Obama to
head the NIH, taking over for Raynard Kington, who had served as the agency's acting director since last year. Collins's nomination is
confirmed by the Senate on August 7.
August
The
FDA's chief drug approver is hit with allegations of a conflict of interest, and the head of the agency's division on medical devices is resigning amid claims that he was making decisions that betrayed close ties to industry.
September
Researchers
announce that an experimental HIV vaccine candidate confers modest protection against the virus in a trial of 16,000 Thai volunteers on September 24. The preliminary results, released in a press conference a month before their publication,
raise concerns that the vaccine's effects may be a statistical anomaly. The
published data confirmed the positive effect; researchers say the vaccine is not potent enough to be used on its own, but can shed light on future vaccine development efforts.
October
The US Department of Agriculture announces the launch of
a new federal funding agency for academic agricultural research, the National Institute of Food and Agriculture, on October 8.
The Nobel Prize in
Physiology or Medicine (October 5) and in
Chemistry (October 7) goes to research on telomeres and ribosomes, respectively. Three women are among this year's awardees.
November
Icelandic genomics company deCODE, which has produced at least 30 top-tier genetics papers in the past two years alone,
files for bankruptcy on November 17, after a long financial struggle. Company CEO Kari Stefansson, who cofounded deCODE in 1996, says that for the most part operations will continue as usual.
Results of two promising gene therapy trials, on top of a handful of recent successes,
suggest the field is beginning to put its troubled past behind it.