Federal Government To Develop Its Own Drugs In Effort to Spur Pharmaceutical Industry
Faced with a diminished drug-development pipeline in the private sector, the Obama administration is starting a federal drug development center, aiming to spur the creation of new medicines.
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The new National Center for Advancing Translational Sciences will get $1 billion in funding to conduct drug research with the goal of attracting private investors. Federal scientists may go so far as to start human trials if necessary, the New York Times reports. Federal officials want the center to open as soon as October.
The National Institutes of Health usually focuses on basic research — like describing the structure of proteins, the Times points out. It’s up to pharmaceutical companies to translate those structures into drugs. But under the new translational sciences center, the institutes might take discovery a step further, such as testing a new chemical in animals or even in human trials — steps that have traditionally been taken by industry, the Times explains.
The Food and Drug Administration has approved fewer and fewer new compounds every year since 1995, the Times reports. Meanwhile, big pharma has been scaling back research spending, and drug giants like Merck and Pfizer have laid off thousands of scientists in the past year alone.
One of the biggest hurdles is cost — it’s really, really expensive to produce a new drug, with an average price tag (from discovery to commercialization) of $1.3 billion, according to a Jan. 5 report from Tufts University’s Center for the Study of Drug Development. It’s also difficult to predict whether a new compound will become popular enough to earn that money back, like, say, Viagra or Lipitor.
Given that uncertainty, and the regulatory hurdles inherent in developing a new drug, pharmaceutical companies have been reluctant to move forward with new compounds. Amazingly, this means promising drugs for the treatment of depression and illnesses like Parkinson’s disease are going untested, the Times says.
The pharmaceutical industry spent $45.8 billion on research last year, which easily dwarfs a $1 billion investment from Uncle Sam. What’s more, funding is still unclear, because Republicans in the House of Representatives have pledged to cut spending for discretionary programs like this. But an influx of funding could help spark new research in otherwise unprofitable areas, like drugs for mental illness, doctors say.
Pharma firms urged to refuse US capital punishment drug
Doctors are backing a call by Health Minister Philipp Rösler for German drug firms to refuse to supply a key agent used in lethal injection executions to the United States.
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The barbiturate anaesthetic sodium thiopental is used in – among other things – the cocktail of drugs given to inmates sentenced to death. The US will soon stop manufacturing the agent, meaning it will be forced to buy its sodium thiopental from other countries.
Rösler has called on the pharmaceutical industry not to supply drugs that include sodium thiopental – also known under the trade name Sodium Pentothal – to the US.
On Monday he received the support of the German Medical Association (BÄK).
“The German pharmaceutical industry can demonstrate that they trade ethically, if they join in here,” Frank Ulrich Montgomery, BÄK vice president, told the Passauer Neue Presse.
Daily Süddeutsche Zeitung recently reported that Rösler wrote to the drug industry asking them to ignore requests from the United States for supplies of the barbiturate.
“As far as your firm markets medical products containing sodium thiopental, I would like to ask you urgently not to meet such requests for supply,” Rösler wrote.
Montgomery described Rösler’s initiative as “a great idea.”
Sodium thiopental is included in drug mixture used in 35 US states in lethal injections to execute prisoners.
Sodium thiopental also has more mainstream uses as a general anaesthetic.
The American Medical Association has also decided not to co-operate with death sentence punishments.
Thiopental shortage to linger with Hospira’s exit
The highly anticipated Q1 2011 resumption of sodium thiopental manufacturing is no longer to be. Hospira is exiting the business and thus adding to the woes of surgeons and executioners alike.
The sole U.S. manufacturer of the anesthetic said Friday it will no longer produce the drug. But Pentothal is an older anesthetic, says Reuters, and doctors have moved on to other anesthetics during its shortage.
State penal systems are likewise turning to alternative drugs, as well as alternative sources. An Oklahoma execution last month relied on pentobarbital. And Arizona prison officials were able to obtain sodium thiopental from a non-U.S. supplier, while officials in Nebraska have found a source in India.
The Italian government is likely the straw that broke Hospira’s Pentothal back. The company had planned to produce the drug at its plant there. But the government stipulation that the drug be used for medical purposes only–and specifically not for executions–was more than the drugmaker could agree to. “We cannot take the risk that we will be held liable by the Italian authorities if the product is diverted for use in capital punishment,” the statement says. “Exposing our employees or facilities to liability is not a risk we are prepared to take.”