Medical Groups Critical of Proposed Tobacco Settlement

July 1, 1997

WASHINGTON--The Marlboro Man's long-anticipated final ride into the sunset will likely be delayed, as the proposed tobacco settlement that would ban his image appears to be headed for a long and heated debate.

WASHINGTON--The Marlboro Man's long-anticipated final ride into thesunset will likely be delayed, as the proposed tobacco settlement thatwould ban his image appears to be headed for a long and heated debate.

The provision in the settlement banning the use of humans and cartoonsin cigarette advertising may be noncon-troversial, but numerous other elementsof the settlement are receiving close scrutiny and criticism from medicaland public policy groups--a prologue to the contentious debate the agreementwill likely face in Congress.

The proposed settlement was negotiated by the tobacco industry, sevenattorneys general representing the 40 states that have sued the tobaccocompanies for reimbursement of Medicare funds spent on treatment of tobacco-relateddiseases, and a group of plaintiff's lawyers. The sole public health groupinvolved in the negotiations was the Campaign for Tobacco-Free Kids.

The agreement requires the tobacco industry to make concessions on advertising,labeling, and smoking in public places, and to pay $368.5 billion in thenext 25 years to compensate the states for medical care of smokers, financeanti-smoking programs, and pay for health care of uninsured children. Inreturn, the tobacco companies would get protection from class action lawsuitsand limits on punitive damages from individual suits.

Although medical groups are supportive of the document's general goalof reducing tobacco consumption, experts interviewed by Oncology News Internationalexpressed major concerns about many of the provisions.

Two important sticking points are the restraints the settlement wouldplace on the FDA's ability to regulate nicotine in cigarettes and the inadequacyof the penalties for failing to meet goals in reducing underage tobaccouse.

'Paralyzes the FDA'

"The agreement virtually paralyzes the FDA from regulating nicotinein cigarettes," said John F. Banzhaf III, executive director of Actionon Smoking and Health (ASH), a national nonprofit legal action and educationalorganization fighting for the rights of nonsmokers. Mr. Banzhaf led thesuccessful campaign to ban cigarette commercials on television and to limitsmoking in public places, restaurants, and airplanes.

The FDA currently has the right to regulate nicotine as a drug and cigarettesas a nicotine delivery system. A federal court decision last spring thatupheld this right is being appealed by the tobacco companies. Under thesettlement, the FDA could immediately reduce nicotine levels and couldban nicotine from cigarettes in 12 years, but with several significant,if not prohibitive, restrictions.

The FDA would have to prove that the action--lowering nicotine levelsor banning nicotine--would lead to measurable improvements in health, wouldbe technologically feasible, and would not create a substantial marketfor "contraband or other tobacco products that do not meet the productsafety standard," in other words, a black market.

The FDA's decision would then be reviewed by Congress, and the tobaccoindustry would have the right to judicial review of any such action, alegal process that could take years.

Pennies per Pack?

Critics of the agreement also think that the financial penalties wouldnot be enough to curb the industry. Although $368.5 billion sounds likea tidy sum, even divvied up over 25 years, critics speculate that the mostof the money could be raised by increasing cigarette prices. Furthermore,most of the sum would be tax deductible as a business expense.

As part of the settlement, the tobacco industry would have to take stepsto dissuade underage smoking, and if it does not decrease by 60% in 10years, the industry would be fined $80 million for each percentage pointshort of the goal, with a cap of $2 billion annually.

Critics say, however, that this penalty would amount to only a few penniesper cigarette pack. In addition, the agreement contains a loophole thatwould allow the companies up to a 75% abatement of the penalty if theycould prove to the FDA that they had complied in good faith with the provisionsof the settlement.

"The deal is basically a settlement for a few cents on the dollar,most of which will be paid by the public and by smokers themselves,"Mr. Banzhaf said.

Lowell Schnipper, MD, of Beth Israel Hospital, Boston, and chair ofASCO's public issues committee, also considers the penalties too modestin light of the industry's enormous profits. He said in an interview thatthe document is really a first draft and any legislation that comes outof Congress could be quite different.

Nothing to Stop Overseas Sales

Mr. Banzhaf noted that "there are no provisions in the settlementwhatsoever to protect 95% of smokers, that is, those who are outside ofthe United States."

Dr. Schnipper echoed this concern: "The agreement made no attemptto address the issue of the export of tobacco products to countries outsidethe United States, which to us at ASCO is a significant omission."

In a separate interview, Ernst Wynder, MD, executive director of theAmerican Health Foundation, also said that a more global viewpoint on tobaccocontrol is needed and that any settlement should benefit not just US childrenbut all the world's children. Dr. Wynder, with Evarts Graham, wrote thelandmark paper linking lung cancer and tobacco.

Action on Smoking and Health, the organization headed by Mr. Banzhaf,is one of some two dozen medical and health advocacy groups sitting ona panel that is reviewing the agreement for Congress and the White House.

The Koop-Kessler panel, named after its co-chairs, C. Everett Koop,MD, former US Surgeon general, and David Kessler, MD, former director ofthe FDA, does not appear to be in a mood to compromise on these issues.Dr. Koop has called the plan as it stands "absolutely unacceptable."