Agency Lags Behind Private Sector in Guideline Development

LONG BEACH, Calif--The Office of Technology Assessment recentlygave a rather harsh assessment of the performance of the Agencyfor Health Care Policy and Research (AHCPR), stating in its reportthat the agency has been largely unsuccessful in evaluating treatments,in preparing practice guidelines, and in saving significant health-caredollars, said Samuel Turner, an attorney with Fox, Bennett &Turner, Washington, DC.

Physicians are seeking protection from medical malpractice claimsthrough the use of practice guidelines, and, in fact, some stateshave established affirmative defenses against malpractice claimsfor physicians who are able to show that they followed approvedguidelines, Mr. Turner said at the 1995 Quality of Life Symposium,sponsored by St. Mary Medical Center.

The question arises whether outcomes assessment and practice guidelinesshould emanate from the Federal government through the AHCPR orfrom private sources such as medical societies, he said.

In its 5 years of existence, the agency has completed only 15practice guidelines, at a cost of roughly $1 million per guideline.In contrast, the private sector has completed more than 1,500practice guidelines at an average cost of $100,000 or less.

The combination of seeming inefficiency and high cost of the agency'sperformance makes it a primary target for budget cuts. "Andso I think we're in an environment where the private sector ispoised to pick up the cudgel and do the job of health servicesresearch where perhaps AHCPR has fallen short," he said.

He feels that the only area of legal concern to the private sectorin drawing up guidelines is the Federal antitrust law, which,in general, forbids competing entities from colluding to developcollective policies that might impact on how they do business.

A guidance issued last year by the Federal Trade Commission andthe Department of Justice, which share antitrust jurisdiction,created, in effect, a safe harbor for practice guidelines, hesaid.

"If you simply collect and share outcomes data, or if youdevelop standards for patient management to assist health-careproviders in clinical decision making, then you are not violatingthe antitrust law," Mr. Turner commented. "It is onlywhen you use that information in a coercive way or in a way thatputs pressure on competitors that you may run afoul of the antitrustlaw."

An important point, he said, is that the guidelines should bevoluntary: "They should have enough force of science andmedicine behind them so that people will want to adhere to them,but every effort should be made to avoid coercion."

He also said that medical societies can look to the AHCPR as apossible source of funding for development of guidelines, citinga $676,000 grant the agency gave to the American GastroenterologyAssociation to prepare guidelines for colorectal screening.

The FDA and the First Amendment

A related issue, Mr. Turner said, is the dissemination of researchresults, especially outcomes data and cost-effectiveness research,both of which are essential to the development of practice guidelines."This is especially true in cancer care, where survival isoften not an appropriate endpoint," he said.

Pharmaceutical companies are eager to get reliable outcomes assessmentsand cost-effectiveness data as a means of differentiating theirproducts in a competitive marketplace, while managed care planswant this information to help keep costs down.

But FDA policies regarding drug labeling may inhibit the disseminationof such data by the drug industry. "The problem is that theFDA views any kind of data associated with drug marketing in thesame way it does drug labeling," Mr. Turner said. "So,to use any of these data in its marketing, the drug company wouldhave to show that the research meets the same standards that theFDA imposes for the approval of a new drug application."

Since drug companies are unable to determine in advance whetherthe FDA will regard the data as consistent with the FDA labeling,they are hindered from distributing the information to physicians.The FDA also refuses to provide guidance in advance as to themethodology that might be used in designing cost-effectivenessstudies to make them acceptable to the agency.

Furthermore, the FDA prohibits the pharmaceutical industry fromdisseminating information about unlabeled uses of their products,including even the distribution of articles from peer-reviewedjournals.

Restrictions also apply to physicians who discuss off-label usesin their talks at medical education programs sponsored by pharmaceuticalcompanies. Speakers must meet standards of balance and objectivitydetermined not by the academic institution or the physician himselfbut by the FDA, Mr. Turner said.

He pointed out that the American Society of Clinical Oncologyand a number of cancer patient advocacy groups have actively opposedthis policy.

Mr. Turner also noted that these policies could change, pendingthe outcome of a lawsuit in Washington, DC. The suit was filedon behalf of physicians who claim a right under the First Amendmentto be free of this kind of interference by the FDA.

The lawsuit also claims that the FDA lacks the statutory authorityto construe drug labeling in so broad a manner as to prohibitdrug companies from disseminating research data.