WASHINGTON _ The controversy surrounding Genentech Inc.and its marketing of recombinant growth hormone emerged inCongress Wednesday but a key witness _ the company itself _declined to appear.Genentech, of South San Francisco, chose instead to supply Rep.Ron Wyden, (D-Ore.), chairman of the House Committee on SmallBusiness subcommittee on technology, with a statement defendingits marketing practices. But the company's reluctance to appearindicates how tangled Genentech's affairs have become.Genentech's spokeswoman Laura Leber said: "We declined toappear because of the ongoing investigations."Paramount among the company's troubles is a 51-count federalindictment handed down in August. The indictment alleges that thecompany's vice president of sales and marketing, Edmon Jennings,and Caremark Inc., of Northbrook, Ill., Protropin's majordistributor, violated Medicare anti-kickback laws.To add to the company's woes, Wyden in August asked the FDA toconduct its own probe into the marketing of growth hormone. TheFDA's inquiry has not yielded any results, officials said. It hasbarely begun.A Wyden staffer, who agreed to speak on the condition that hername be withheld, said the congressman's examination ofGenentech essentially arose out of a broader effort to examine"illegal marketing practices and scams to boost sales."Genentech, however, has not been accused of any illegal activity,despite the indictment of a top-ranking executive. Indeed, thecompany has scurried to Jennings' defense. "We're supportive ofhim and will assist him in vindicating himself," Leber said.Last week, the company bowed to pressure and ended anothercontroversy by deciding to suspend its financial support for a heightand weight screening program in public schools. Although thecompany argued that the program was designed to identify childrenwith treatable growth disorders, critics have described it as amarketing tool to boost sales of the hormone.Genentech has said it will ask the Institute of Medicine, anindependent research branch of the National Academy of Sciences,to study the benefits and potential drawbacks of public healthscreening programs sponsored by the pharmaceutical industry. Theinstitute also would be charged with developing standards for suchscreenings.But the testimony of a doctor at Wednesday's hearing illustratedwhy Genentech's screening program may have raised critics'hackles. An endocrinologist from Charlotte, N.C., Mark Parker saidhe prescribes growth hormone for children _ but only whenmedically necessary."I have never recommended growth hormone therapy for any childbefore a proper medical evaluation," he said.Parker's wife, Susan Parker, a nurse, received $36,000 fromGenentech for three years, as part of a consulting agreement toscreen children in the Charlotte- Mecklenburg School System.Parker asserted that his prescribing practices were not affected bythe study. "No children were referred to me," he said.Wyden, in his opening statement at the hearing, said he believesthat "such practices, when so closely linked to a manufacturer, andin some cases to local prescribing physicians, represent a marketingeffort." He praised Genentech and Caremark for halting thescreening and "direct research grants to clinicians."He said both companies have agreed to "cease providing officeoverhead support to doctors in the form of nurses and officeequipment."Despite Genentech's action, the company continues to defend thepractice _ and Susan Parker's grant. "We don't believe there is aconflict of interest," Leber said. "Susan Parker is a decoratedpediatric endocrinology nurse. The work she did for us, we believe,was a very valuable contribution to public health."In Genentech's defense, she cited a study published in the July issueof the Journal of Pediatrics by a team of Utah endocrinologistsindicating that one of every 3,480 children _ about 20,000 a year_ produce deficient quantities of natural growth hormone, and thathalf of those go undiagnosed and untreated.Leber said screening programs could benefit not only those childrenwho might benefit from hormone treatment but also many morewhose lack of growth velocity is caused by some other undiagnosedcondition such as malnutrition or brain tumors.While some children with bona fide hormone deficiencies gountreated, another broader controversy surrounds the use of growthhormone to treat children who are not hormone-deficient. Twostudies, by teams of researchers in Israel and Rome, published inthe August issue of the same journal suggest that while growthhormone is beneficial in children who do not produce naturalgrowth hormone, its effectiveness falls off in children who haveadequate _ if not abundant _ endogenous supplies of thehormone. "The drug is approved only for growth-hormone deficiency andthat is how we promote it," Leber said. n
-- Steve Sternberg Special To BioWorld Today
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