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Americans Are New Guinea Pigs for $500 Billion Pharmaceutical Industry

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Published on Saturday, December 18, 2004 by Knight-Ridder

American Consumers Suffering as More New Drugs Debut in US, Analysis Shows

by Tony Pugh and Seth Borenstein

WASHINGTON - Thousands of Americans are getting sick and many are dying each
year from prescription drugs that were pushed onto the U.S. market ahead of
the rest of the world.

A Knight Ridder analysis shows that as the number of new drugs given first
to Americans has increased, the reports of drug-induced ailments have
soared. Yet, even as the deaths and damage have increased, the Food and Drug
Administration has never instituted an aggressive system to track the safety
of drugs once they're on the market.

On Friday, the makers of the painkiller Celebrex and the attention disorder
remedy Strattera warned consumers that health problems associated with the
drugs had surfaced, requiring changes in their use. Both were introduced
first in the United States, Celebrex in 1998, Strattera in 2002.

Nearly 60 percent of all the genuinely new drugs sold in the world in 2003
- those with active ingredients never before marketed - were first dispensed
in America. That's up from about 3 percent 20 years ago when most drugs were
first introduced abroad, where the approval process in many countries is
much more stringent than in the United States.

"We're the guinea pigs in the sense of extensive population exposure," said
Dr. Marcus Reidenberg, a professor of pharmacology, medicine and public
health at Cornell University Medical School in New York City.

FDA officials strongly deny that their safety monitoring system is broken
and say it's great that most new drugs make their debuts here.

"Lives are saved and suffering is reduced in the U.S." because drugs for
cancer, diabetes and other ailments are released here first, said Dr. Steve
Galson, the FDA's acting director of the Center for Drug Evaluation and
Research, which oversees drug safety.

Knight Ridder found that in 1992, just before Congress directed the FDA to
speed up drug approvals, there was an average of one adverse drug reaction
for every 16,300 prescriptions filled. In 2003, adverse reactions hit one in

While the FDA has no official estimate on the number of people killed by
these drugs, the agency says 106,000 people a year die from all types of
drug reactions. One new drug, the painkiller Vioxx, which was pulled from
the market this fall, may have caused 55,000 deaths, a top FDA scientist
said recently.

Prescription drug safety is under severe pressure because of several

? The 12-year-old law that cut drug approval time nearly in half.
? Price controls in many other countries that make the U.S. market,
the world's largest with sales of $216 billion in 2003, much more profitable
and attractive to drug makers.
? Widespread consumer advertising for prescription drugs in the
United States that puts public pressure on regulators and physicians.

These problems worry FDA scientists.

A FDA survey of agency scientists, released last week by a public interest
group, found that 66 percent of respondents were less than fully confident
in the FDA's ability to monitor the safety of drugs being given to

"We believe very strongly that, overall, the fact that drugs are (first
introduced here) is a very, very strong positive benefit for the public
health of America," the FDA's Galson said.

But on Friday, one of those drugs, Celebrex, was found in one study to
increase the risk of heart attack. FDA officials advised doctors to minimize
its use.

Vioxx and Celebrex are in a class of painkillers known as cox-2 inhibitors,
which are popular with arthritis patients because they are easier on the
stomach than previous pain medications. Consumer advocates have railed for
years that the FDA has failed to act aggressively after numerous studies
linked cox-2 drugs to heart problems.

Vioxx and Celebrex were sold in the United States before they were sold in

In 1998, the United States surpassed Europe and Japan as the world leader
in the introduction of unique medicines.

Knight Ridder's analysis found that 72 percent of unique new drugs approved
by the FDA in the last six years were sold in America before they were sold
in Europe. In the 1980s, most were launched in Europe.

Europeans adopted more aggressive ways to evaluate the safety of drugs
already on the market. Great Britain, for example, keeps track of all drugs
and how patients react to them and looks for emerging problems.

"You know their (monitoring) system would have picked up a problem earlier
than ours would have," said former FDA Commissioner and Stanford University
president emeritus Donald Kennedy. "Because (Europeans) are better than us -
way better."

That may help explain why the number of Americans reporting adverse drug
reactions is soaring. The 357,392 bad reactions reported to the FDA in 2003
is more than double 1995's figure and more than four times higher than those
reported in 1990.

The FDA's Galson said the increase may reflect the fact that more Americans
- roughly 44 percent - now take prescription drugs.

But the number of adverse drug reactions is growing more than twice as fast
as the number of prescriptions being filled in the United States. From 1994
to 2003, the number of bad drug reactions reported jumped 145 percent while
the number of prescriptions filled increased 59 percent, Knight Ridder

The FDA estimates that about 390,000 adverse reactions will be reported
this year. Yet the FDA cautions that the actual number is likely to be
between 10 and 100 times higher because of under-reporting.

The issue of drug reaction and monitoring is a simple case of numbers.
Before the FDA approves a drug as safe for sale, it's tested on a few
thousand people. It's enough of a sample to find big and obvious side
effects, the kind that hit maybe one out of every 100 users.

But when drugs are sold commercially and used by millions of patients, rare
side effects can show up, some with deadly consequences. A rare side effect
that would hurt maybe one person in 10,000 wouldn't show up in the initial
study, but it would in the mass marketplace. That's what happened with

"We launch into overuse of these drugs when we don't know their effects,"
said Dr. Brian Strom, a University of Pennsylvania public health and
preventive medicine professor.

That means consumers should be wary.

"If you don't want to be a guinea pig, don't take them for the first couple
of years after they've been approved," said Sean Hennessey, a University of
Pennsylvania professor of pharmacology and epidemiology. "It's a common
teaching in clinical pharmacology that it's never good to be the first
person to use a new drug."

Pat Peebles, a 60-year-old retiree in McDavid, Fla., started taking Vioxx
in 2001 for arthritis. She figured it was safe because the government
approved it.

Pat Peebles, a 60-year-old retiree in McDavid, Fla., started taking Vioxx
in 2001 for arthritis. She figured it was safe because the government
approved it.

But on the night of Sept. 23, 2003, Peebles began to sweat profusely. She
felt pain in her stomach, then fell to the floor. Her heart stopped, and
paramedics spent 45 minutes reviving her.

By then, experts knew something was amiss as studies and international
alerts linked the drug to heart problems. By 2001, Vioxx was the No. 1
prescription drug problem in the FDA's adverse effects reporting system.

"I'm more cautious because of that night that I died," said Peebles, who's
now on other medications. "... When (drug companies) come up with these new
drugs and say the government approved it, I wonder if it's going to be safe
down the road."

The United States became drug makers' choice for new drug debuts after
Congress passed the Prescription Drug User Fee Act in 1992. The law allowed
drug companies to fund most of the FDA's costs for approving new drugs. In
return, the FDA pledged to cut sharply drug approval times.

Faster approval of HIV drugs - the legislation's goal - was the first
result. Then came a rash of new U.S. drug applications that shifted from
Europe and Japan, where approval was relatively slow.

"There's more money here, a bigger market, less price regulation than
anywhere else in the world," said Stephen Schondelmeyer, a professor of
pharmacy at the University of Minnesota.

Maintaining drug safety while approving more drugs, according to the FDA's
Galson, "means that we have to have a robust post-approval program" to
detect problems once drugs are on the market.

That's not what the FDA has, says Dr. Wayne Ray, a professor of preventive
medicine at Vanderbilt University in Nashville, Tenn. The system, he said,
"is broken."

The system is designed to be passive: Doctors, drug companies and patients
report adverse reactions to the FDA, which keeps the records in a giant
database. What's needed - but not done - is active searching of these
records and other databases for patterns of problems and any side effects
from new drugs, said experts.

In fact, so few doctors or patients submit adverse reaction reports and
drug company submissions are so spotty that the database is little more than
a collection of anecdotes, said Pennsylvania's Hennessey.

In addition, most of the 300,000-plus adverse reaction reports that the FDA
receives annually are on paper, said Galson, and computerizing them is "a
very time-consuming process."

Complained Strom: "We shouldn't be relying on this 1950s system as our way
of discovering adverse reactions."

The FDA does offer doctors an electronic reporting system for adverse
effects, called Medwatch, but the agency does little to promote it, said Dr.
Mary Frank, president of the American Academy of Family Physicians. "I can
tell you as a physician in practice for 26 years that I have never heard
from the FDA about that."

The FDA's record-keeping problems even afflict the World Health
Organization's Uppsala Monitoring Centre in Sweden, which collects adverse
drug reaction reports from 75 countries to spot early signs of problem

FDA-provided reports make up nearly half of the agency's trove of 3.2
million, said Sten Olsson, head of external affairs at the Uppsala Centre.
But the reports arrive a year after they're filed, making it difficult to
spot problems with new drugs before they get out of hand.

"We got 30,000 to 50,000 reports from them last month that were a year old.
... It's very difficult to tell what problems we might have identified if
we'd had their data," in a timely manner, Olsson said.

The FDA could do a lot more, said Dr. Richard Platt, chairman of preventive
medicine at the Harvard School of Medicine in Boston. He recommended that
the agency scour private-sector databases of patient records for possible
side effects, just as Kaiser Permanente, a big U.S. health care manager, did
to discover cardiac problems with the painkiller Vioxx.

"Are we doing the obvious?" asked Lisa Herrinton, a research scientist at
Kaiser Permanente's Division of Research in Oakland, Calif. "No, we're not."

She and others say the FDA isn't investing enough in monitoring side

And how much is that? After two weeks of searching their budget records,
FDA officials said they still don't know.

However, the Bush administration has significantly increased the number of
FDA personnel involved in post-approval drug safety surveillance. It's up to
103 this year, from 77 three years ago. That comes to one FDA drug safety
monitor for every 31 million prescriptions filed in the United States.

More federal workers do maintenance and landscaping on Capitol Hill than
check for adverse drug reactions nationwide.

It's not a new problem. Twenty-five years ago next month, Congress' Joint
Commission on Prescription Drug Use offered this as its top recommendation:
"A systematic and comprehensive system of post-marketing drug surveillance
should be developed."

It still hasn't happened.


For more information on:

The FDA's adverse drug reporting system:

The FDA's safety-based drug withdrawal list 1997-2001:

A 2002 FDA look at preventable adverse drug reactions:

A 1999 FDA presentation about the need for better post approval drug safety

The FDA's 1999 plan to fix its drug safety:

The FDA advisory on Strattera:

The FDA advisory about Celebrex:

Knight Ridder researcher Tish Wells contributed to this report.

© Copyright 2004 Knight-Ridder