The American Spectator

January, 1995

LENGTH: 8667 words

HEADLINE: Double-Crossing to Safety
The reign of Bush backstabber Dr. David Kessler at the Food and Drug
Administration has been marked by hunger for regulations and addiction to power.
Here's why he's about to become the Republicans' juiciest target.

BYLINE: James Bovard is the author of Lost Rights: The Destruction of American
Liberty [St. Martin's Press].

Over the crest of the hill on Fishers Lane in suburban Rockville, Maryland,
there it was: the 18-story, ugly-enough-for-government-work building that houses
perhaps the most powerful regulatory agency on earth. A throng of humanity stood
in front of the building, as if milling about after a fire drill. Only up
close did it become clear that they were actually engaging in an activity
frowned upon by the building's higher-ups, sucking on cigarettes as a wino pulls
on his last slug of Ripple. It's a fitting welcome to the fiefdom of Food and
Drug Administration Commissioner David Kessler, Washington's most powerful
bureaucratic czar, with regulatory control over a trillion dollars worth of the
nation's GNP and an agenda that would criminalize everything from the
manufacture of shower commode chairs to the voluntary use of dread tobacco.

One of the clearest test cases of whether a Republican Congress can begin to
rein in big government will be the forthcoming battle over the future of the
FDA. Newt Gingrich has denounced the FDA as "the leading job killer in America,"
and floated a plan to replace it within five years with an agency staffed with
biomedical entrepreneurs, not career bureaucrats. But Gingrich is surely in for
a hell of a fight.

Kessler has overseen an unprecedented expansion of regulatory interference
and meddling by the agency. A former agency official describes him as a
"zealot," but zealotry seems a weak term for the intrusive and deadly
bureaucracy of Kessler's FDA. It has confiscated millions of dollars of
inventory from pharmaceutical and other companies, and destroyed thousands of
private-sector jobs. It has set grim records with its absurd delays of the
approvals for new medical devices. It has "knowingly submitted false
information to Congress," according to an investigation of the agency by the
staff of Sen. Orrin Hatch.

The FDA has strangled the free exchange of information about new and
innovative uses for medicines. Newsletters, books, and television programs that
disseminated the latest in treatments and therapies have been stifled or closed
down. The Food and Drug Administration under David Kessler has become a
self-perpetuating bureaucracy that, in an effort to protect its own
prerogatives, costs the lives of people it is supposed to protect.

Kessler Saves His Skin

Power, rather than safer and better foods and medicines, seems to have been
David Kessler's chief concern ever since arriving at the FDA in 1990. Kessler
was tapped for the agency by President Bush, largely to unsnarl a bureaucratic
labyrinth that was delaying the approval of new drugs. Instead, he did the
opposite: He twisted federal law to dramatically increase the FDA's power and
dramatically expand its bureaucracy. "Since Kessler has been here," says one
high-ranking FDA staffer, "we are turning out regulations faster than ever
before. And they are more intrusive than ever before."

Kessler--who refused many requests for an interview for this article--would
not have disagreed; a month after Clinton won the 1992 election, Kessler cited
the increase in FDA regulations on his watch during a speech in Washington that
was an open audition for the Clinton administration. The commissioner had been
actively campaigning to keep his job for months, "working furiously behind the
scenes," as a Bush official told Forbes. "Even during the campaign, he tried to
schedule dinner with Al Gore." Kessler's speech, given at the annual Food and
Drug Law Institute conference, was as overtly political as possible, even
blatantly co-opting the rhetoric of the president-elect.

"I am here today to talk about change," he crowed, "and while the national
dialogue for change has been in vogue during this election year, it is fair to
say that on this one the Food and Drug Administration has been ahead of the
curve. We're getting new regulations out faster than ever before." He even
boasted about creating a new Office of Criminal Investigations, and observed,
"We rely much less on voluntary agreements, and much more on court-enforceable
consent decrees." Kessler is in many ways an archetype of Washington in the
Bush-Clinton years, a perfect example of the blind faith in government power and
the contempt for private ingenuity that has permeated the last two
administrations.

When Clinton sent the White House the names of a handful of Bush appointees
he wished to retain, Kessler was on the list. But Kessler had already been so
adamant about keeping the post that, after Bush ordered all political
appointees to submit their resignations, he refused. Kessler reportedly wouldn't
sign the form letter sent to him for that purpose until a special White House
courier was sent to his office to pick it up. When Bush received Clinton's list,
he agreed not to accept Kessler's resignation--compounding the original mistake
of hiring him in the first place. That meant that Clinton would not have to
renominate the commissioner, thereby averting a bloody confirmation hearing at
the hands of Republicans irate over what one called "disloyal, traitorous"
conduct. Kessler had retained control of his powerful fiefdom, and soon enough
was playing Hillary Clinton's tune by denouncing the greed of the pharmaceutical
companies--even while she was selling them short on the New York Stock Exchange.

Orange Crush

Shortly after taking power, Kessler discovered an excellent means of
toughening the agency's image--and turning himself into an anti-capitalist folk
hero. In early 1991, the FDA threatened Procter & Gamble on the grounds that the
company might be guilty of misleading consumers with its use of the word
"fresh." Makers of a reconstituted juice called Citrus Hill Fresh Choice,
Procter & Gamble responded by filing a request for an "urgent FDA rulemaking,"
arguing that there were currently seventy-nine different uses of the word
"fresh" by food processors; the company also pointed to consumer surveys that
showed people did not think "Fresh Choice" meant fresh-squeezed.

Kessler's FDA responded with a Federal Register notice announcing that it was
"reviewing the statements that it has made on the use of the term 'fresh' on
food labels," and requesting "that industry not make use of this term pending
adoption of a final rule on this subject." Such rule changes often take a decade
or more, and the FDA's request would have required every food company that used
"fresh" on its labels to abandon its labeling immediately--in other words, to
take a suicide leap off the shelves of America's grocery stores.

Procter & Gamble lawyers argued that their client's labeling was not
misleading because "Made from Concentrate" was also on the label; FDA officials
retorted that it should have been in larger print. Kessler then took sweeping
action: He ordered U.S. marshals to seize the juice--12,000 gallons, as it
turned out--and destroy it. Federal law declares that a "misbranded" or
"mislabeled" product is automatically unsafe, and provides FDA with the
authority to confiscate the merchandise. As Kessler later told the New York
Times Magazine: "The law says that a false and misleading claim adulterates the
food. I don't need anything more than that."

Maybe not, but there was nothing unsafe about the orange juice at all; the
seizure was purely a political ploy for power, which is why Kessler timed the
raid to coincide with a speech he was giving in Florida at the annual convention
of food-and-drug lawyers. He began the speech by articulating his aspirations
for the agency: "To restore the FDA to its former position of preeminence in
matters involving food." Weeks later, associate FDA Commissioner Jeff Nesbitt
announced, "The agency expects any and every company to make sure that its
labeling is consistent with FDA policy, which has been in place for several
decades. And if they don't, and if the FDA finds out about it, then those
companies can expect similar action."

In fact, the rules for the labeling of food products were more in flux than
ever before. Congress had just passed the Nutrition Labeling and Education Act,
and the FDA would later issue over 4,000 pages of regulations and commentary on
the new rules. With regulatory confusion in the air, Kessler's get-tough policy
couldn't fail to strike terror in the boardrooms of food companies nationwide;
just a simple change in labeling requirements could cost a company its entire
system of brand-name identification. But as Kessler expanded the reach of the
FDA, he had far more on his mind than merely the labels on orange juice cartons.
He wanted major attention from the press, and he was going to get it.

Vitamin Villains

Rep. Henry Waxman, chairman of the House Subcommittee on Health and the
Environment and a longtime Kessler confidant, was holding a hearing on dietary
supplements on July 29, 1993. The hearing was to be televised, and to prepare
for the publicity barrage, the FDA sent an unusual, "not for public
distribution" memorandum--dated July 8--to all of its district offices, which
began as follows:

In preparation for Congressman Waxman's July 29, 1993, hearing on dietary
supplements, Dr. Kessler is eager to collect information on dietary supplement
products currently on the market and the claims being made for them.
Consequently, we are requesting the district offices to conduct an undercover
survey of dietary supplements. Due to the sensitive nature of the subject the
assignment should not be discussed outside of the office.

Each district office was required to assign three inspectors to make six site
visits to local health-food stores. FDA undercover agents went into the stores
and baited employees into making health claims about products in the store.
According to the FDA's interpretation of its own rules, if an employee makes a
claim about a product, the product is automatically "mislabeled"--and thus
subject to confiscation. At the subcommittee hearing, Kessler claimed that
health-food stores routinely made outlandish statements about their products. He
waved a 105-page report before the cameras that his staff had written on the
supposed crimes of the industry. Kessler thundered: "We are slipping back to the
turn of the century, when snake-oil salesmen roamed about. Never has there been
a systematic evaluation of vitamins. The marketplace is awash in unsubstantiated
claims. It is time to do what needs to be done."

While Kessler was denouncing the supplements industry for deceptive
practices, he himself was pulling off a scam of enormous proportions. The report
he waved for the benefit of his audience was a hastily cobbled together prop
that was, to be generous, slipshod and marred with errors. An evaluation of the
report by Sen. Orrin Hatch's staff was less kind: "This false and misleading
document is so riddled with inaccuracies that it lacks any evidentiary value,
and raises serious questions about the motives of those who are responsible for
its preparation. The FDA has knowingly submitted false information to Congress
and it has willfully violated the presumption of accuracy and impartiality
traditionally granted the agency."

Hatch staffers examined the actual reports of the undercover agents and
discovered that Kessler had grossly misrepresented many of the incidents. In
several cases, a health-food clerk's handing an undercover agent a reference
book that described a certain product was characterized as a "false claim." Of
the report's list of 528 products with unsubstantiated claims of health
benefits, 142 were not manufactured, sold, or distributed by the company to
which the FDA attributed them. One of the offending items was a paperback book.
Thirty-four of the "products" did not even exist.

Kessler's report claimed the products "all have one thing in common: Not one
of the claims has been substantiated by the FDA before their appearance in the
marketplace." This was blatant disingenuousness: The FDA refuses to accept
practically any of the evidence of medical journals, clinical studies, and other
valid sources on the benefits of vitamins and supplements. Thus, because the FDA
refused to approve the private companies' claims, Kessler declared they must all
be presumed to be liars.

"Freedom of choice," said Kessler, "means little unless consumers have
meaningful and accurate information on safety and effectiveness in deciding
whether to purchase these products." It was a final bit of phony bluster for the
cameras--in fact, the FDA has not acted on even one of the 528 alleged false
claims in the report.

Meanwhile, the number of FDA employees assigned full time to regulating the
vitamin and supplement industry has increased fourfold since 1992. Just as it
did with Citrus Hill orange juice, the FDA is also confiscating extraordinary
quantities of vitamins and dietary supplements. On May 6, 1992, a platoon of
sixteen FDA inspectors and local police in flak jackets carried out a no-knock
raid, smashing in the door of the Tahoma Clinic in Kent, Washington. They held
the staff at gunpoint, ostensibly so that nobody could try to hide the vitamins.
The raiders seized more than $100,000 in products and office supplies--including
address books and diaries--and spent 14 hours cleaning out the office; they even
tore the phones out of the wall. FDA agents were supposedly concerned about
the clinic's use of injected B-vitamins, which have been widely used in Germany
with no adverse health problems. Though the FDA claimed that Dr. Jonathan
Wright--the founder of the clinic and a highly visible critic of the agency--was
engaged in dangerous health practices, it has not filed any charges against him
in court. More than two years later, the FDA has yet to return any of the office
records or other material it seized from Wright.

More than 100 million Americans currently take dietary supplements to bolster
diets, enhance "well-being," or combat illness. In late 1993, the FDA issued
regulations that prevented vitamin producers from making any health benefit
claims for their products. Yet the consensus in the scientific community on the
benefits of vitamins--based on hundreds of articles in medical journals--has
become stronger than ever. The FDA is thus issuing regulations that impede the
public's right to know which substances might make them healthier and stronger.
Congress passed an act in October to rein in the FDA's oversight of the vitamin
industry, but, as attorney Jonathan Emord observes, the new law is full of vague
phrases that could be invoked to expand the agency's arbitrary power.

But that's just vitamins. With medicines, David Kessler's FDA is doing
something far worse: It is costing Americans their lives.

No New Pills

For almost twenty years, pharmaceutical manufacturers, consumer advocates,
and policy wonks have been complaining about the FDA's unconscionable delays in
approving life-saving new drugs. The complaints are well-founded. A recent study
by Tufts University found that it took an average of almost nine years for new
drugs to receive final approval. Tufts also found that most of the new drugs
that the FDA approved were already on the shelves in foreign countries by the
time the FDA made them available to Americans.

Those delays have meant thousands of deaths. Sam Kazman of the Competitive
Enterprise Institute estimates that as many as fifteen thousand people died
during the FDA's review of misoprostol, which reduces gastric ulcers. Kazman
surmises that twenty-two thousand may have died while the FDA approved
streptokinase, which dissolves blood clots in heart-attack victims. And while
patients die because they cannot gain access to potentially life-saving drugs,
the FDA is devoting its resources instead to cracking down on drugs already on
the market. By enforcing arcane regulations about alternate uses of
already-approved drugs, the FDA has stifled free access to information about
other uses of available medicines.

Pharmaceutical manufacturers must get FDA approval for each recommended use
of their drug, but researchers often discover that a drug is effective at
treating other types of disease than the ones for which it was originally
developed. These findings are written up in medical journals, newsletters, and
other publications. Pharmaceutical companies have routinely publicized the
results of further research on their drugs after FDA approval, thereby alerting
physicians to other possible ways to save lives. American Medical Association
Vice President Roy Schwarz estimates that "off-label" uses of drugs may
constitute up to 60 percent of all drug prescriptions. Indeed, says Schwarz, "In
some cases, if you didn't use the drugs in the off-label way, you'd be guilty of
malpractice."

But Kessler has waged war on the dissemination of information about off-label
uses of drugs. In 1991, he prohibited pharmaceutical companies from informing
doctors of new uses for approved drugs, and indicated that the FDA would enforce
the ban with seizures, injunctions, and prosecutions. The results, as former FTC
official John Calfee noted, were these:

Cancer newsletters have been shut down. Symposiums have nearly been brought to
a halt . . . Press conferences announcing new applications [usually from
controlled clinical trials] are for the most part eliminated. . . . A leading
support group for cancer patients has strongly objected that the new policy will
keep patients from receiving the best therapies. Oncologists have declared that
patients will die because physicians will not learn of efficacious treatments.

A 1988 study showed that the risk of heart attacks for males over 50 was
reduced by 50 percent by taking an aspirin each day. In July 1989, however, the
FDA forbade manufacturers from advertising the benefits, on the grounds that
aspirin was not labeled as heart medicine. According to the British Medical
Journal, wider publicity of the "aspirin-a-day" preventative medicine practice
could save ten thousand American lives each year.

In 1991, researchers at the National Heart, Lung and Blood Institute reported
that Vasotec, a hypertension drug made by Merck & Co., sharply cut the number of
cardiovascular deaths in people suffering from chronic congestive heart failure,
and curbed heart failure among people with damaged hearts. But, as Business Week
noted, Merck's sales force "couldn't give doctors copies of published studies
about the new research or similar earlier studies. In fact, doctors can call the
Food and Drug Administration toll-free to inform on companies giving out such
information." Research at the National Heart, Lung and Blood Institute is
federally funded; thus we have the bizarre spectacle of one federal agency
prohibiting the dissemination of another agency's research.

The FDA has also been suppressing the sale and distribution of medical
textbooks to enforce its ban on information it does not want disseminated.
Medical textbooks often discuss the latest developments in pharmaceutical use,
including uses not yet ordained by the FDA. Pharmaceutical companies often
distribute free copies of textbooks to physicians, both as a courtesy and a
sales device. The FDA has now decreed that when a drug company gives free
textbooks to doctors that mention an off-label use of that company's products,
the FDA can confiscate all of the drugs. The rationale? The mention of the
off-label use in the textbook supposedly makes all the drugs "misbranded"--and
thus unsafe for the public.

Perhaps most importantly, the FDA's tactics are intimidating textbook
publishers, who fear that including the latest information on drug uses may
result in the FDA restricting sales of their books. According to Kim Pearson, a
colleague of Kessler's on the Senate Labor and Human Resources Committee in the
early 1980s and publisher of Food and Drug Insider Report, "Several companies
have abandoned plans to include the most up-to-date drug use information
disclosed by medical journals for fear that the FDA will restrict distribution
of their texts in retaliation." If the texts have too much information on
off-label use for the FDA's taste, the publisher could lose one of the most
lucrative outlets for its books.

The FDA prohibition on mentioning new uses of approved drugs effectively
turns back the clock five years on the advancement of medical science, and
imposes a "cost of truth" test that requires spending millions of dollars and
the loss of countless lives.

Disabling Medical Devices

Kessler's FDA has further retarded the progress of treatments by drastically
increasing the approval times for medical devices--a category that includes such
products as mint-flavored dental floss and wheelchair cushions. From mid-1992 to
early 1994, the backlog of requests for minor improvement modifications of
existing medical devices increased from only twelve applications to over a
thousand. The FDA review time for major new medical devices has increased from
337 days in 1988 to almost 800 days now, according to the Biomedical Market
Newsletter. In 1989, the FDA approved fifty-nine new breakthrough medical
devices; in 1992, it approved only twelve such devices.

A survey last summer by the Minneapolis Star-Tribune found that Minnesota
firms planned to create 1,700 jobs in foreign countries during the next five
years--largely because of FDA delays in approving medical devices stateside. The
survey also found that Minnesota medical-device firms in recent years have
increased their foreign hiring almost three times faster than their U.S. hiring.
More incredibly, the FDA in many cases will ban the export of medical devices
made in the U.S. even when a foreign government has already approved the
device--simply because the FDA has not given its approval. A survey by the
American Electronics Association found that "40 percent (of device companies)
reduced the number of U.S. employees because of FDA delays, 29 percent
increased their investment in foreign operations, and 22 percent moved U.S. jobs
overseas." Whereas in Germany it would require four months and $10,000 to get a
new medical device approved, the FDA requires four years and $8 million,
according to one medical executive.

A June 1993 congressional report noted that forty-nine American-made medical
devices bogged down in FDA review have already been approved for sale in Europe,
Japan, and other countries. The report concluded, "Many of the small companies
that populate the industry may be driven out of business altogether by
regulatory delays. The process also means that Americans are denied health-care
options that could be safer, more effective or less costly than those on the
market today." Chicago lawyer Robert Pristave observed that the FDA's approval
process for major new medical devices "has become so laborious that leading FDA
legal specialists are now regularly advising their device manufacturing clients
to manufacture and sell their products only outside the U.S."

The pettiness of some FDA enforcement efforts is nearly incomprehensible.
Last June 14, agents swooped down on the headquarters of the Seattle-based
Synetic Systems to seize a device the agency thought posed serious risks to the
American people. The device? The "Sharper Image Relaxation System" machine. The
crime? FDA compliance officer Darryl Thompson claimed the machines come under
the agency's purview because they are intended to "affect the structure or
function" of users, and that since the company did not gain FDA approval, its
machines were automatically--like food--"adulterated." The FDA considers the
machine so dangerous that it placed the machine in the same category as heart
pacemakers--even though there have been no injuries reported from its use.
Synetic surrendered to the FDA because it could not afford to spend hundreds of
thousands of dollars fighting the federal government in court.

Christopher Conway, CEO of a California medical device firm, observed: "We
are no longer surprised at anything the FDA does. Under the present
administration, the FDA's actions have been arbitrary and unpredictable, and it
has become virtually impossible to bring a new medical product to the public."

Kicking the Habit When It's Down

Kessler's most celebrated grab for power came during recent controversy
surrounding the tobacco industry. Late last year, the ABC News tabloid
newsmagazine "Day One" began contacting Kessler to make comments for a program
they were preparing accusing tobacco companies of manipulating the nicotine
level in cigarettes to addict smokers. Kessler demurred, while his staff
repeatedly requested to see what evidence the tabloid program had gathered. When
Kessler's staff heard a rumor that the program was about to air, an FDA staffer
called ABC to verify the air date, baiting them with the possibility that
Kessler might finally do the interview.

On Thursday, February 24, 1994, ABC confirmed that the program--with its
headline-making accusations--would air the following Monday. Kessler used the
information provided by ABC to scoop the network, announcing the next day--three
days before the show aired--that he was launching an investigation into whether
tobacco companies were manipulating nicotine in cigarettes. Rep. James Clyburn
observed a few weeks later, "It appears that Dr. Kessler rushed to accuse the
cigarette manufacturers of misconduct to avoid being beaten to the punch by a
tabloid news program."

Since then, Kessler, himself a former pipe-smoker, has made false accusations
while keeping the press in a frenzy over allegations. In his statement of
February 25--a letter to the group Coalition on Smoking or Health--Kessler
announced, "It is our understanding that manufacturers commonly add nicotine to
cigarettes to deliver specific amounts of nicotine," and accused cigarette
manufacturers of putting nicotine in cigarettes "to satisfy an addiction on the
part of some of their customers." According to the New England Journal of
Medicine, however, the average level of nicotine in cigarettes has fallen by
more than 50 percent since 1955. The level of nicotine in cigarettes is
significantly lower than it is in natural tobacco.

Kessler, however, was not about to let truth interfere with his assault on
the tobacco industry. Kessler told a congressional hearing the following
month that since manufacturers have the technology to remove nicotine from
cigarettes, the fact that cigarettes have any nicotine at all might prove that
manufacturers intend to addict smokers. Cigarettes, he declared, may simply be
"high-tech drug delivery devices."

In June, Kessler returned to Capitol Hill and accused the Brown & Williamson
Tobacco Company--makers of Kool, Viceroy, and Raleigh--of secretly and deviously
creating a type of tobacco in Brazil with double the normal nicotine amount in
order to make its cigarettes more addictive. Doubling the amount of nicotine in
a type of tobacco simply allows a manufacturer to blend the high-nicotine
tobacco with lower-nicotine tobacco to achieve any desired level of nicotine per
cigarette. Since the Federal Trade Commission regulates and mandates that
nicotine levels be published on cigarette packs, manufacturers cannot use new
types of tobacco to covertly turn smokers into helpless zombies.

Kessler gravely concluded that these facts "lay to rest any notion that there
is no manipulation and control of nicotine." The New York Times printed
Kessler's allegations on its front page--and then, the following day, printed a
highly publicized correction admitting a stunning error. The cigarettes that
Kessler accused Brown & Williamson of making with the super-high nicotine
tobacco actually had only average nicotine levels. Brown & Williamson blended
the new tobacco type with other tobacco parts to create a
normal-nicotine-level cigarette. The media hailed Kessler anyway; after his
error-filled testimony, ABC World News Tonight named Kessler the "Person of the
Week." ABC's Peter Jennings gushed that Kessler "is an activist, no doubt, in a
job which has often been burdened by bureaucrats. He conducts himself as the
people's guardian in matters of food and drugs with the utmost conviction."

Kessler ordered the FDA's Drug Abuse Advisory Committee to meet and decide
whether nicotine is addictive. The panel held two days of meetings in early
August; the testimony was so stacked in favor of Kessler's position that the
tobacco industry was given only one hour to argue. The Washington Times derided
the process as a "hastily organized show trial." When the panel voted nicotine
was indeed addictive, Kessler publicly announced: "This was a very significant
finding. It is a clear answer to the tobacco industry rhetoric about freedom of
choice."

Kessler is seeking to portray greatly increased restrictions over tobacco as
the equivalent of a war to free the slaves. But his attack is based largely on a
gross exaggeration of the power of cigarettes. Over 40 million adults have quit
smoking in recent decades; there are now more ex-smokers than smokers in the
U.S. The percentage of Americans who smoke has fallen sharply since the Surgeon
General's landmark 1964 report on the dangers of smoking. Kessler had declared
in June, "Everyone knows that cigarettes are not good for you. But I'm not
sure that everybody really understands how bad they really are." In fact,
according to a study by Duke professor Kip Viscusi, smokers significantly
overestimatetheir chances of dying from cigarettes: While almost half of the
surveyed smokers said they expect to die from the lung, throat, or heart
problems caused by smoking, the surgeon general in 1991 estimated that only
18-36 percent of smokers would die as a result of smoking.

Watch Out, Arlen Specter

At staff meetings, Kessler has recently cultivated the egotist's habit of
referring to himself in the third person, in sentences like, "The Commissioner
of the Food and Drug Administration cannot tell the American people that the
government will not help them." One former high-ranking FDA official observed
that he thought Kessler has always acted like he is planning to run for the
Senate. Remarkably, Kessler and friends are reportedly discussing the
possibility of his running for president. Either way, it would be out of
character for Kessler to seek people's permission to represent them.