Cautionary tale of science commercialisation

The blood of a two-week-old baby being collected for a phenylketonuria (PKU) screening. The screening test was invented in 1960 by microbiologist Dr Robert Guthrie.
Photo by US Air Force/Staff Sgt Eric T Sheler.
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Thursday, 29 August 2013

The inventor of one of the most widely used health screening tests for newborn babies would have found today's attitudes to the commercialisation of science "distasteful", according to international research involving the University of Adelaide.

In a paper published today in the New England Journal of Medicine, Dr Diane Paul (Harvard University and University of Massachusetts Boston) and Associate Professor Rachel Ankeny (University of Adelaide) detail the commercialisation-gone-wrong story of the Guthrie test, also known as the newborn heel prick test.

Invented in 1960 by microbiologist Dr Robert Guthrie, the heel prick test takes blood from newborn infants to screen for the genetic condition phenylketonuria (PKU) which, if left untreated, can lead to mental retardation, seizures, and other health problems in children.

"Efforts to patent and license the Guthrie test generated controversy at the time but it is not as well known today as it should be. This episode in history can be seen as a cautionary tale for the current debates about commercialisation of research, such as the gene patenting debate," says Associate Professor Ankeny, from the University of Adelaide's School of History and Politics.

Guthrie believed that commercial production of testing kits would be the most efficient way to rapidly screen more than 400,000 babies across the United States. He filed a patent application and signed an exclusive licensing agreement with a commercial laboratory, handing over his percentage of the profits to groups dedicated to helping children.

When the company couldn't produce enough test kits, Guthrie started making them himself at home, for a cost of $6 a kit. He later discovered that the company planned to charge $262 for their kits.

"Guthrie was appalled by this, and when the company ignored his appeal to drop the price, he alerted public health authorities who had funded most of the research," Associate Professor Ankeny says.

The surgeon general of the Public Health Service later repealed the licensing agreement.

"This whole episode was painful for Guthrie, who realised he'd made a serious mistake in signing the licensing agreement," Associate Professor Ankeny says. "He had a commitment to universal screening and to public health.

"Although attitudes towards commercialisation, and laws, have swung in the opposite direction since the Guthrie case, this story from our recent history still has great relevance.

"The key principles debated in the Guthrie case underlie the the conflicts that remain today: between political and economic imperatives to commercialise research, and the social and moral imperatives to promote public health."

The full paper can be found at the New England Journal of Medicine's website.

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