US drug firm to be quizzed over growth hormone

BMJ 1994; 309 doi: (Published 03 September 1994) Cite this as: BMJ 1994;309:559
  1. J Roberts

    Government agencies in the US are to investigate whether the drug firm, Genentech, has been inducing doctors to prescribe its recombinant human growth hormone to normal children with short stature. The Food and Drug Administration and the Federal Trade Commission will conduct the inquiry.

    The drug, marketed as Protropin, is approved for use in children with growth hormone deficiency and chronic renal insufficiency but not in those with short stature that does not have a hormonal cause. But once a drug is on the market doctors can prescribe it for conditions for which it has not been approved if they think that it can help. It has not been proved that the drug is successful in children with short stature.

    In August a federal grand jury indicted a Minneapolis doctor for allegedly accepting payment to prescribe Protropin. The doctor admits to having treated 350 children with the drug, and he is accused of having accepted about $1.1m (£720 000) since 1985. The grand jury also named a Genentech executive and Caremark, the distributor that has sole rights to provide Protropin to American doctors. The doctor, the executive, and Caremark have denied any wrongdoing. And, even though Genentech was not accused, the indictment cast suspicions on the Californian company. Protropin costs patients on average $30 000 (£20 000) a year. According to the Human Growth Foundation, about 20 000 children in the US (about 1 in 2500) are “medically eligible” to take the drug. Genentech says that it provides Protropin to about 15 000 children. The drug's annual sales of $217m (£140m) represent about a third of Genentech's income. Eli Lilly produces a similar drug, Humantrope, but its sales are smaller even though it is cheaper than Protropin.

    Congress has asked the Food and Drug Administration and the trade commission to look further into the relationship between Genentech and the Human Growth Foundation, which is based in Virginia. Congressional critics say they believe that Genentech has supported the foundation's work and may have directly profited from it. The foundation and Genentech worked on a campaign to identify children with short stature and to persuade them to see paediatricians. What the foundation called “health screening” the government is calling “product marketing.” Tax records show Genentech provided about 53% of the foundation's revenues in 1991 and 1992.

    “Our height screenings no more drum up business for growth hormone than eye screenings drum up business for ophthalmologists,” said a spokesman for the foundation.

    A representative of Genentech said that its behaviour would be illegal only if the company influenced the foundation's public health programme, which he denied.

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