NICOTINE WARS--Part VII--Feds, Pharms & the FDA

No other governmental bureau under the U.S. Public Health Service has such a long and documented history of abuse and corruption as the Food and Drug Administration. And none has as intimate a relationship with the pharmaceutical industry. The FDA has absolute power to determine which drugs and medical devices can be marketed in the United States, how these products may be marketed, how they are labeled, how they may be used, and whether they are available over the counter or by prescription only. It is judge, jury, acquitter or executioner, and enforcer for every product manufactured for sale in the United States by the pharmaceutical, medical device, food and cosmetic industries.

Approval of its drug by the FDA can mean hundreds of millions of dollars in profits for a pharmaceutical company; FDA rejection of a promising drug can financially ruin a small company and deliver a multimillion-dollar hit to a big one. Given this kind of power and the huge amounts of money involved, it is not surprising that the agency has often been rocked by corruption scandals and that individuals in the agency have been found to be on the take.

"Several FDA reviewers were accepting bribes to hasten the approval of certain companies' applications and derail those submitted by competing companies. Eventually 42 persons and 10 companies were found guilty of criminal acts."
Robert Higgs, "An FDA Fable," Reason Magazine, October 1994. This describes a generic drug scandal that climaxed in 1989. Beginning in 1990, when David Kessler was appointed head of the FDA, and for three years after that, the FDA exacted revenge on Barr Laboratories for blowing the whistle on the agency's corruption. With or without his knowledge, Kessler's FDA reportedly tried to put the company out of business by repeatedly inspecting its facilities and delaying approvals of its products.

"Warner-Lambert [purchased by Pfizer in 2000] played down the potentially fatal risks associated with troglitazone during the [FDA] approval process and received help from federal drug regulators in pushing the drug towards marketing approval, an article published in the Los Angeles Times has claimed."

"The newspaper based its report on company and government documents, some secretly obtained, as well as email communications, which shows that officials from Warner-Lambert had collaborated closely with certain senior officials in the US Food and Drug Administration (FDA) during the approval process and later, when the company was being pressured to take the drug off the market."
Reported in The British Medical Journal, 322; 696, March 24, 2001. This scandal took place between 1994 and 1996, during David Kessler's reign as head of the FDA.

The agency has been investigated for corruption by the U.S. Congress and Congress has tried to "reform" the FDA. In 1997 a congressional FDA reformation effort went nowhere because it was reportedly sabotaged by Sen. Edward Kennedy (D., Mass.).

In 1990 David Kessler was appointed head of the FDA. The hope was that Kessler, a "dedicated activist" who was also an attorney and physician, would clean up the FDA, but what actually happened was that corruption at the FDA continued while Kessler focused on such things as food labeling, further politicized the agency, and instituted a reign of terror.

Armed with virtually unlimited power, Kessler promoted the image of the FDA "protecting" the public with the implacable sword of justice. However, Kessler's sword tended to swing at some companies and some industries more than others.

In 1991, FDA storm troopers raided a Florida orange juice producer and poured 24,000 half-gallons of Citrus Hill 'fresh choice' juice down the drain because the agency objected to the label. There was nothing wrong with the juice, but the FDA said the phrase 'fresh choice' on the label was misleading since the product was not "fresh" but was made from concentrate.

In 1992, the FDA headed a guns-drawn raid on a Tahoma, Washington medical clinic because the physician in charge of the clinic had promoted nutrition and vitamins as an alternative to some traditional medical treatments.
In 1993, the FDA fined start-up company Lexicor $1,580,000 (twice the company's total 1993 revenues) for promoting its electroencephalographs which measure brain waves, even though the company had received FDA approval for the device, which it was selling under a different brand name.

On the other hand, Summit Technologies, a Massachusetts manufacturer of laser eye surgery devices, was supported by the FDA in selling a $40,000 device for $400,000. The FDA was aware that Summit may have been violating federal law by pre-selling an unapproved device along with an already-approved device, but the company's political connections apparently influenced the FDA decision not to prosecute. The company had collected nearly $500,000 in campaign contributions for Sen. Edward Kennedy, and according to a whistle-blower the chairman of Summit discussed a potential payment of more than $1 million to Kennedy's reelection campaign.

Then there is the case of Ethicon and the contaminated sutures. Ethicon, a subsidiary of Johnson & Johnson, manufactures 80 percent of all medical sutures used in operations. The company accidentally distributed at least 3.6 million packages of contaminated sutures to medical supply distributors, hospitals and physicians between December 1993 and September 1994. According to class-action attorney Wendy York, the contaminated sutures were unknowingly used by surgeons and physicians all over the country, and their use resulted in raging infections, disfigurement and even death in patients who had been stitched with the medical sutures [Geoff Metcalf, worldnetdaily Sunday Q & A, Interview with Wendy York].

Did the FDA conduct an armed raid or levy a multimillion-dollar fine on Ethicon? No. According to attorney York, the FDA did issue a stern warning letter to Ethicon in 1994, but the company assured the FDA it would take care of the problem, and no further action has been pursued by the government agency.

One would gather that Ethicon and Summit "maintained positive relationships" with Kessler's FDA, while other food companies, drug companies, and medical clinics did not.

During Kessler's reign at the FDA, the agency initiated at least two new policies which would result in increased profits for at least the major pharmaceutical companies.

In May 1995, the FDA ruled that a new federal law extended drug patents for up to an additional three years. This news was welcomed enthusiastically by the big drug companies. Glaxo Wellcome's Nancy Pekarek said, "This is very good news, not just for Glaxo but for upholding the patent rights of innovative companies" (Miami Herald, 5/26/95). But consumer advocates said this windfall for the pharmaceutical companies could cost U.S. consumers as much as $6 billion.

Then in 1997 the FDA relaxed the restrictions on TV ads for prescription drugs. This gave the big pharmaceutical companies a big new marketing tool because they could promote their prescription drugs directly to the consumer. Obviously the smaller companies are without the means to pay for glossy professional television spots, but the big drug companies were quick to take advantage of television marketing for prescription drugs. Sales of these drugs soared as people began pressuring their physicians for prescriptions for the products they had heard so glowingly described in primetime TV ads.

And, of course, David Kessler also gave a big boost to the sales of the big pharmaceuticals' "nicotine replacement" products for smoking cessation when he went after the tobacco companies.

In 1991, Kessler's FDA approved the Nicotrol and Nicoderm patches as prescription drugs for smoking cessation (Nicorette gum had been approved for such use in 1984). In 1992, the patch was introduced to the American public. In 1993, the FDA prohibited the sale of existing over-the-counter smoking-cessation products because the agency said they had not been demonstrated to be effective. This, of course, had the effect of eliminating all competition to Johnson & Johnson's Nicotrol patch and SmithKline Beecham's Nicoderm patch and Nicorette gum. Then in 1996 the FDA approved the gum and the two patches for over-the-counter sale. It all worked out extremely well for Johnson & Johnson and SmithKline Beecham.

But by far the biggest boost for the pharmaceuticals in the nicotine war was David Kessler's attempt to regulate tobacco products as "nicotine delivery devices" under FDA jurisdiction.
Kessler first publicly expressed his interest in regulating tobacco when he went before Congress in 1994 and asked for "guidance" and "direction" before his agency took any action to regulate tobacco. Prior to Kessler, the FDA had never expressed an interest in extending its regulatory empire to tobacco. Tobacco products were not considered to be food, cosmetics, drugs or medical devices, which meant they did not fall under the scope of the FDA's regulatory apparatus.

However, the anti-regulatory mood of the Republican-led Congress meant there was no legislative enthusiasm for giving the FDA authority to regulate tobacco products.

Kessler then by-passed Congress altogether. In 1995 he declared tobacco to be a "pediatric disease" and submitted to the very receptive Clinton White House a list of proposed FDA tobacco regulations ostensibly intended to protect the children from tobacco.

Meanwhile, the Robert Wood Johnson Foundation was funding policy studies to support FDA regulation of tobacco products. In 1994 the RWJF awarded a $142,600 contract to Mathematica Policy Research for a "National Tobacco Survey" which would assess public attitudes "toward various government policy measures designed to limit youth access to tobacco products and make those products less attractive." David Kessler later said the findings from the survey "played a critical role in winning the necessary support for the FDA's tobacco control policy."

Joseph DiFranza was given a $99,999 RWJF grant for "Investigating the Scientific and Legal Basis for Regulations Requiring the Generic Packaging of Tobacco Products," and Alan Morrison and David Vladeck of the Public Citizen Foundation were awarded a $50,608 RWJF grant for a legal analysis of the proposed FDA regulations on tobacco.

By August 1996, the Clinton administration was set to approve new FDA regulation of tobacco products. Tobacco products would be considered "drug delivery devices," and thus would be subject to FDA regulation with regard to advertising, marketing, and packaging. Cigarette vending machines would be outlawed, tobacco advertising would be banned from magazines with high youth readership, advertising on billboards would be limited to black and white text and prohibited within 1,000 feet of schools. Furthermore, the tobacco companies would be forced to fund a $150 million annual anti-smoking education campaign. And if all these measures did not cut underage smoking in half within seven years, the FDA would be empowered to employ even harsher measures, including the banning of cigarettes as a "nicotine delivery system."

The newly formed, RWJF-funded Campaign for Tobacco-Free Kids beat the drum for the proposed FDA rules. "This is the first national policy in history that will stop tobacco companies from marketing to kids," said TFK's Brian Ruberry (quoted in Brian McGrory, "New FDA rules would declare nicotine a drug," The Boston Globe, 8/22/96).

Not only would the proposed FDA regulation of tobacco products expand the agency's already wide scope of regulatory power, but it would increase its budget by 30 percent or more since the agency would get considerable extra funding to cover the cost of implementing and enforcing these regulations.

The tobacco companies immediately filed suit against the FDA to stop the new regulations. After a protracted legal battle, the case reached the U.S. Supreme Court. In March 2000, nearly three years after David Kessler resigned as head of the FDA, the Supreme Court ruled that the FDA lacked congressional authority to regulate tobacco.

But the battle over FDA regulation of tobacco products isn't over. The Robert Wood Johnson Foundation and organizations it funds are still working to convince Congress to empower the FDA to regulate tobacco products as nicotine delivery devices and shift the market advantage to the pharmaceuticals' own nicotine delivery devices. And David Kessler is touring the world to promote his new book, "A Question of Intent: A Great American Battle With a Deadly Industry," about his "heroic" battle to destroy demon tobacco.

Speaking of David Kessler: Here is an article he did that appeared in the Bangor Daily News on the 31 July 01.

Ex-FDA chief describes tobacco wars

By Misty Edgecomb, Of the NEWS Staff

BAR HARBOR — Less addictive than a horror movie, and more addictive than cocaine — depending who you ask — tobacco isn’t easy to define.

But that’s precisely what Dr. David Kessler set out to do during his tenure from 1990 to 1997 as commissioner of the U.S. Food and Drug Administration.

Within days of his confirmation, Kessler was approached with the idea of investigating a single, simple question — if the FDA regulates food and drugs and everything that comes in contact with the body, why couldn’t the agency regulate tobacco products?

That meeting started Kessler on a seven-year odyssey that some say led to the downfall of big tobacco and its closely guarded secrets. “No one had ever been inside before, and no one knew what we would find,” Kessler said. “That started us on a real-life detective story.”

In fact, reviewers have described Kessler’s recently published account of his seven years at the FDA, “A Question of Intent,” as a mystery — not the typical description for a work of nonfiction chronicling a government bureaucracy.

Monday night, Kessler shared his story during the 6th Annual Leonard Silk Memorial Lecture at the Mount Desert Island Biological Laboratory in Salisbury Cove.

When he began to fight what he terns the “tobacco wars,” Kessler was discouraged on every front. Congress, lawyers, lobbyists and fellow regulators all advised him that the quest was a “fool’s errand” and “political suicide,” he said.

“I totally misjudged the power of the industry — they got Congress to investigate us, to cut our budget. They could buy almost anyone they wanted,” Kessler said.

In part, because of the brick walls at every turn, it took two full years for Kessler to refine his investigation to whether nicotine was a drug under the law, specifically whether tobacco manufacturers intended nicotine to produce its proven pharmacological effects.

“Not proven, not proven, not proven — that was a mantra for 50 years,” he said. “They created just enough doubt in people’s minds. It was probably the greatest deception ever to put the nation’s health at risk.”

Kessler’s department found industry informants, like researcher Jeffery Wigand, whose part in the investigation was portrayed in the film, “The Insider.”

But the investigators weren’t fluent in the lingo or the procedures of the highly secretive world of big tobacco. They didn’t even know what they were looking for, Kessler said.

“I didn’t even know there were secrets there when we started off. I could almost promise you that we still don’t know everything,” he said.

From their anonymous whistleblowers, FDA officials heard stories of super-tobacco with double the nicotine content. They saw chemical additives permitting smokers to free-base nicotine, and deceptions in labeling and advertising as blatant as blending the highest nicotine levels into “light” cigarette brands. They saw intentional marketing campaigns to hook women and children.

“Documents started begetting documents, and they started flowing,” Kessler said.

All in all, hundreds of internal documents revealed a half-century-long cover-up. “We are, then, in the business of selling nicotine, an addictive drug,” reads one 1963 report.

“When we started getting our hands on hundreds of documents, in their own words, I knew,” he said.

Kessler first rode a wave of success, testifying before Congress and exposing the skeletons that littered every closet. Finally, tobacco executives admitted nicotine’s addictive properties, and they are now actively seeking regulation.

He resigned from the agency in 1997 with a sense of a job completed.

Last year, the FDA suffered a discouraging setback when their proposed regulatory structure was shot down by the Supreme Court in appeal.

But Kessler didn’t realize his truest success until after he left the administration. The FDA may have the court, but it won the public mind.

“We were aiming at the heart of the industry and we didn’t know it,” he said. “It’s all about public perception.”

With Kessler’s passionate testimony on nicotine addiction as a pediatric disease — he’s been likened to a revival preacher — the public began to see smoking not as a sign of personal freedom but as evidence of manipulation, Kessler said.

“Once you realize that it’s a child who’s making that choice at 11 or 12 — it’s no longer a choice,” he said. “Three thousand children begin smoking every day; 1,000 die prematurely.” “If you speak to people who’ve been addicted to heroin and cocaine and cigarettes, they say it’s easier to give up the cocaine and the heroin,” he said.

Today, as dean of the Yale University School of Medicine, Kessler has turned down an invitation to take part in negotiations between the government and tobacco executives, but he isn’t shy about making his opinions on the controversial issue known.

“I have concerns about which side the current administration is on,” Kessler said.

“Contributions have flowed to the president, and on some of the international issues he has sided more with industries than with public health.”

Current efforts at public relations advertising, lauding the “We Card” program and tobacco companies’ humanitarian efforts, have no chance, nor any intention, of convincing people not to smoke, he said.

“That’s to influence jury pools,” he said, asserting a belief that the tables have turned. The infallible big tobacco teeters at the brink of bankruptcy, he said.

“This is about survival,” Kessler said.

Ex-FDA chief describes tobacco wars

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