The oncologist who works for a tobacco company -- a rare combination, to be sure -- was in a rush to get back to his hotel room in Washington. Dr. Lars-Erik Rutqvist needed to cram for a landmark hearing on tobacco before the U.S. Food and Drug Administration, where he was sure he'd be quizzed intently.
Rutqvist is an executive with Swedish Match, the Stockholm-based maker of a smokeless tobacco known as snus. And his company has asked federal regulators to find that its product is less dangerous than cigarettes. It’s a tall task. And a controversial one.
Swedish Match wants to soften the warning labels printed on its snus cans, stripping away dire mentions of mouth cancer, gum disease and tooth loss that the U.S. requires on all smokeless tobacco. The company says it has science to support its case. It points to what it calls the "Swedish Experience," where high rates of tobacco use hasn't translated into high rates of cancer. And with Rutqvist’s help, the company filed a 120,000-page report ahead of the first-of-its-kind FDA hearing set for Thursday and Friday.
It can all sound a bit mad, given that tobacco is considered public health enemy No. 1. Rutqvist, a cancer doctor, understood that.
“It has divided even the tobacco control community,” he said during a brief break from his preparations.
“But it’s pragmatic,” Rutqvist added. “And I like that.”
Swedish Match’s unusual campaign strikes at the heart of a bitter debate over how we think about tobacco. Most public health officials view tobacco in any form as dangerous. It’s why even electronic cigarettes are so contentious.
But some public health officials – including prominent scientists -- question whether the “all tobacco is bad” approach is actually smart medicine. They argue that smoking tobacco poses the greatest risk by far, and anything that reduces the number of smokers is a positive. In their eyes, that means giving snus a boost by altering the warning label. They advocate for what’s known as “harm reduction.”
But many tobacco researchers are dismissive of this practice.
“Their ideas have not caught on because they are not very good ideas,” said Dr. Stanton Glantz, a professor of tobacco control at the University of California, San Francisco, who wrote a letter strongly opposing Swedish Match’s FDA application.
The two camps of public health researchers agree on little, noted Dr. Kenneth Warner, a public health professor at the University of Michigan.
“Right now, it’s not a civilized debate," said Warner, an advocate of harm reduction. "There’s a lot of animosity.”
Rutqvist, 60, didn’t start out believing in harm reduction.
For more than two decades, he studied different cancers at the major research Karolinska Hospital in Stockholm. He published reams of studies. And for years, he held the traditional view that all tobacco was bad. Then, in the late 1980s, he worked on the largest study of oral cancer in Scandinavia. The study found disease risk increased with smoking and drinking, but not with using snus.
“I was surprised,” Rutqvist recalled.
The study had hit upon what today is widely accepted as “the Swedish Experience.” It describes the paradox that Sweden posts one of the highest tobacco-use rates in Europe, yet it has the lowest rates for smoking-related deaths, including lung cancer. The difference is that relatively few Swedes smoke. Instead, they consume snus. Nearly 20 percent of Swedish men and 3 percent of Swedish women use it.
In 2001, as evidence accumulated, the Swedish government even removed the oral cancer warning from snus sold in that country and replaced it with a message about damaging health.
About the same time, Rutqvist grew disenchanted with the medical community’s prevailing attitude toward tobacco.
“The message is, all tobacco is bad for you: Quit or die,” he said. “But the tobacco harm reduction message is something different.”
In 2006, he took a job with Swedish Match, rising to his current position as senior vice president for scientific affairs. He braced for a backlash from his former oncology colleagues. It never came.
“Everyone in Sweden knows that snus doesn’t have anything to do with cancer,” Rutqvist said.
Swedish Match’s corporate slogan is, “A world without cigarettes.” Nearly half of the company’s $15 billion in annual sales come from snus. But the firm also sells cigars and, in the United States, chewing tobacco under brands such as Redman.
Its General Swedish snus brand has only about 4 percent of the U.S. smokeless tobacco market, which is dominated by traditional chewing tobaccos such as Copenhagen.
But Swedish snus is different than American chewing tobacco -- or even American-made snus. The finely-ground, moist tobacco comes in tiny packets that are traditionally inserted in the upper lip. Users don’t spit. And Swedish snus contains fewer cancer-causing agents than most chewing tobaccos, perhaps because of the way it’s manufactured. Supporters of harm reduction argue that snus is safer than other smokeless tobaccos -- and poses significantly fewer health risks than smoking.
“Can you make the claim that a product is safer when it’s not perfectly safe? Yes, I think you can,” said Lynn Kozlowski, a University of Buffalo professor who studies tobacco use policy. “But there are some who think their job is satisfied only when they say nothing is safe.”
The path that Swedish Match is pursuing was created under the 2009 Tobacco Control Act, the landmark law that gave the FDA authority over tobacco. The act banned the use of “light” and “low-tar” to describe cigarettes because those words could give consumers the false impression that these cigarettes were somehow safer than regular ones. The act also set standards for tobacco warning labels.
The 2009 act also allowed tobacco firms to petition the FDA if they wanted to prove that one tobacco product was safer than another.
Swedish Match filed its voluminous application last June. Later this week, the company will plead its case before the FDA’s Tobacco Products Scientific Advisory Committee, which will make a recommendation to the FDA. A final decision is expected this summer.
In its application, the company contends snus can produce a public health benefit by reducing the risk of tobacco-related diseases.
Swedish Match’s case is based on what’s happened in Sweden and the results from six studies, including two double-blind, randomized trials that compared snus to a placebo for people trying to quit smoking. The company said there’s no evidence that snus users graduated into cigarette smokers. And lab studies of Swedish snus show the product “is associated with considerably lower, if any, carcinogenic potential when compared with cigarettes,” according to the company’s FDA filing.
The FDA, in a preliminary assessment of the application, sounded skeptical of some of Swedish Match's contentions, questioning whether the Swedish Experience could be replicated in the United States.
Glantz, the University of California professor, also worried that a change in snus’ warning label could be interpreted as an FDA product endorsement.
“When you put these things into the market, the market changes,” Glantz said. “It’s hard to convey risk to the public.”
Last week, Rutqvist and a team of Swedish Match officials made a visit to Georgetown Tobacco in Washington. The store has been around since 1964, long enough to see attitudes toward its main product line harden considerably.
Rutqvist strolled past the rows of cigars and cigarettes until he reached a small refrigerator that contained round cans of General Swedish snus.
Rutqvist pulled one out. Printed on the front was a standard FDA-mandated warning: “This product can cause mouth cancer.”
Other cans read “This product is not a safe alternative to cigarettes.”
If Rutqvist and Swedish Match get their wish, the FDA would do away with these warnings, replacing them with “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.” A current warning about smokeless tobacco being addictive would be retained.
David Berkebile watched as Rutqvist and the others huddled around the Swedish snus display. Berkebile, owner of Georgetown Tobacco, smoked a cigar and listened as Rutqvist gave a quick explanation of why he was in town.
“Good luck,” Berkebile said with a laugh.
But Rutqvist said he was optimistic. Yes, there was social and political resistance to his firm’s FDA request they needed to overcome. But, he said, the evidence is so compelling. He is an oncologist, after all. He trusts in the science.