WASHINGTON _ FDA commissioner David Kessler, along withother agency officials, has singled out three objectionable drugmarketing techniques: "seeding" trials, unsubstantiated claims ofsuperiority over competing products and "switch" campaigns.

An article in today's New England Journal of Medicine by Kesslerand his peers acknowledges that the prescription drug marketplacehas grown increasingly competitive, partly due to the proliferation of"me too" drugs. The competition has led some companies to engagein highly questionable practices, according to the FDA authors.

Company-sponsored clinical trials of approved drugs that have littleor no scientific purpose, also known as "seeding" trials, are "thinlyveiled" marketing attempts, according to the article. Features thatmark such trials include recruitment of investigators who are leadingprescribers of competing drugs rather than experts or leadingresearchers, sponsorship of the studies by the company's sales andmarketing division rather than its research department, and thecollection of data that are of little or no value to the company.

In addition, the FDA authors said that some clinical trials testingapproved drugs for unapproved indications are poorly disguisedpromotional efforts. The agency has authority to discontinue suchstudies since off-label promotion by drug companies violates FDAregulations.

Cost-Effectiveness Studies Scrutinized

The article also highlights an age-old practice in the history ofcommerce _ the use of "false and misleading claims." But here, in anew twist, the FDA promises extra scrutiny for cost-effectivenessstudies, a newly favorite tool of sales and marketing departments inthe era of managed care. Indeed, some pharmaceutical andbiotechnology company executives expressed fears during the recenthealth care reform debate that the FDA may one day attempt toexpand its review of new products to include validation of cost-effectiveness studies.

"Promotional materials making claims of cost effectiveness andcomparative effectiveness have become more and more common,"the article states. "Although traditionally the FDA has not beeninvolved in cost-effectiveness issues, its responsibility formonitoring prescription-drug advertising has required it to evaluatecost-effectiveness studies that are used to support advertisingclaims."

The authors point out that there is no scientific consensus on how toconduct cost-effectiveness studies and assert that any cost claimsmust be based on "sound clinical data." They conclude that"prescribing decisions based on inadequate data on comparativeefficacy and cost-effectiveness could result in increased, rather thandecreased, costs for health care."

Finally, the article criticizes "switch" campaigns, in which drugcompanies pay physicians and/or pharmacists directly or indirectly tochange patients' prescriptions from one drug to a competing product.

Many of the FDA's warnings about marketing techniques appeartangential to the biotechnology industry with its focus onbreakthrough rather than "me too" drugs and its preoccupation withearly-stage, pre-approval research challenges. But the recentindictment of a Genentech Inc. executive suggested that maturebiotechnology companies may ultimately face some of the marketingproblems seen in the pharmaceutical industry.

Last August, Edmon Jennings of South San Francisco-basedGenentech was indicted by a federal grand jury in Minneapolis oncharges that he, executives from Caremark Inc. and a Minneapolisdoctor named David Brown engaged in an illegal kickback schemewhereby Brown was paid $1.1 million to promote sales of Protropin,Genentech's recombinant form of human growth hormone. Jennings,Brown and Caremark have denied the allegations.

Part of the indictment centered around a "research grant" program inwhich Jennings authorized payments to Brown via Caremark totaling$254,500 over five years. The indictment alleges that Brown neverproduced research papers or results during that time. In one 15-month period, Brown received $100,00 worth of research grantsfrom Caremark while Caremark received about $4.4 million in"patient referral revenue" generated by Brown, according to theindictment. On the Genentech side, the research grant program wasallegedly approved and managed by Jennings, vice president of salesand marketing, rather than a clinical research executive.

The indictment of Jennings, Caremark and Brown was theculmination of a joint investigation by the Department of Health andHuman Services Office of the Inspector General, the Federal Bureauof Investigation and the Minnesota Health Care Fraud Task Force.Under Congressional pressure, federal agencies have been targetingdoctors, drug companies and health care providers suspected ofviolating Medicare/Medicaid anti-kickback laws and other criminalstatutes.

The FDA does not have the authority to review advertising andpromotional materials before they are introduced. As a result, theagency can take action or impose penalties or corrective actions onlyafter the fact. The FDA's first line of defense against false ormisleading claims made by a company is to write a letter requestingthat the claims be corrected. When violations continue, the FDA mayissue a more serious "warning letter" or initiate legal action throughan injunction, a product seizure or criminal prosecution. In extremecases, the FDA may withdraw its approval of a drug. However, thatoption is rarely chosen since it can harm patients. n

-- Lisa Piercey Washington Editor

(c) 1997 American Health Consultants. All rights reserved.

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