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How well is the safety of the American public assured today by the
system we have for approving and monitoring drugs?

In the 31 years that I've been monitoring the Food and Drug
Administration, what has gone on in the last five and six years is
unprecedented. There have been an unprecedented number and percentage
of drugs taken off the market; in many cases, drugs with known
problems before they came on the market.


There's an unprecedented turnover of top scientists and physicians at
the FDA. We now have three former FDA scientists on our staff. The
absence of congressional oversight to sort of hold the FDA accountable
has also been devastating. So the outcome of all of this is that we've
had more drug safety-related problems in the last four or five years
than really almost any comparable period of time.

The sad thing is these were preventable. They could have been avoided.
In most, if not all of the cases, there were strong danger signals
even before the drug came on the market that there was a problem. In
all cases, once they came on the market, there was a very dangerous
and reckless slowness to respond to the signals that came after
marketing -- signals in the terms of deaths and serious injuries to
people who took the drug once it was on the market. So I think the
combination of problems in the pre-approval phase, combined with a
very defective system for post-market safety surveillance have really
been devastating.

At one time, 10 years ago, I would have said -- and did say -- that
the FDA was the gold standard, that no country was doing a better job,
either in the approval of drugs in the first place, or, secondly, in
finding out as quickly as possible once they came on the market.
That's no longer the case. Other countries that formerly were looking
up to our gold standard are now outperforming us, and protecting
people in those countries much more than we are protecting Americans.


Among the most outspoken and vigilant critics of the FDA and the
pharmaceutical industry, Sidney Wolfe has been the director of Public
Citizen's Health Research Group -- an independent, nonprofit
consumer-advocacy organization -- since it was founded in 1971. He is
also an adjunct professor of internal medicine at Case Western Reserve
University School of Medicine. "Within the FDA," he tells FRONTLINE in
this interview, "there's a very dangerous, unhealthy tension that
results in drugs being approved that shouldn't be approved, and drugs
staying on the market much longer than they should." He goes on to
discuss the reforms that he thinks are needed. This interview was
conducted on Nov. 4, 2002.



What countries do it better now than the United States? What is it
that they're doing?

The caution that used to be exerted by the FDA at the front end before
a drug was approved has weakened. I think that countries such as the
United Kingdom, probably France, are doing a better job.

Once the drug is on the market, there's a system in France called
Pharmacovigilance, which is really vigilance on a drug once it comes
on the market. It's a very carefully, cleverly set up system, so that
every patient who gets a drug in certain parts of the country is
known. Any medical problem that arises with these patients is also
known.

In other words, you get a full accounting of what goes wrong for those
patients. Whereas, in this country, anywhere between 1 percent and 10
percent, at most, of the adverse reactions that occur are reported.
That's very important. If we had a better system, a more complete
system of reporting adverse reactions, it would take maybe six months
instead of a year, or a year instead of two years before we got enough
information to allow us to make a decision this drug should come off
the market, or this drug should have a black box warning.

We published a paper several months ago in the Journal of the American
Medical Association, showing that one out of every five drugs that
came on the market in the United States in a 25-year period ending in
2000 -- one out of every five -- had to either be taken off the market
or was subject to a black box warning.

Now, those decisions to remove from the market or to put a black box
warning on could be made sooner -- thereby sparing large numbers of
lives and bad health that are caused by the drugs -- if we had a more
effective system of reporting. FDA funded an experiment in Rhode
Island back 10-15 years ago, which showed that with an intervention,
they could increase 17-fold the amount of reports that were submitted
-- adverse reaction reports submitted by doctors. It worked well, but
then they stopped the intervention, and the reporting rate went back
down. There's no reason why we can't use this kind of knowledge to
greatly stimulate the amount of reports. But that's just the first
step.

The second step is in analyzing the reports and making a decision as
to what to do. For too long, the analyses that are done in the
post-market surveillance part of the FDA fall on deaf or hostile ears.
The people who are running the FDA, the people who are wedded to the
idea that when they approved a drug, it must have been OK or we
wouldn't have approved it, tend to take very, very negatively the
criticism that comes from those people that do the post-market
surveillance.

Often, usually, the battle is won by the people that want to leave it
on the market, the people who don't want to put a black box warning.
So within the FDA, there's a very dangerous, unhealthy tension that
results in drugs being approved that shouldn't be approved, and drugs
staying on the market much longer than they should.


It seems like, at the FDA, there's not room for people who say there
might be a problem with a drug. Is that the case? And if so, how do
you explain why that's the attitude there?

In the context of the large number of drugs that had to come off the
market in the late 1990s, we did a study of physicians at the FDA who
are in the drug approval division. We found that between them, they
had identified 27 drugs that they thought were too dangerous to come
on the market. But those drugs were approved over their objection.
They eventually signed off on the drugs, but they told us anonymously
in a survey that they thought the drugs should not be on the market.

Many of them also told us in the survey that they were silenced; they
were gagged; they were not allowed to speak out at a public FDA
advisory committee meeting to voice their concerns about the safety of
drugs, if it would interfere with the possibility that the drug might
get approved. ...

The FDA frequently reminds people that the decisions are based on the
best medicine and the best science. You have to have an open
atmosphere of scientific discussion and dispute if that's going to
happen. Despite saying that, FDA scientists have their views
overturned, even when they are saying a drug shouldn't be approved.
FDA scientists are silenced when they would otherwise like to speak up
at a public advisory committee meeting.

So the reality, as opposed to the rhetoric, is really squelching
dissension, putting down people who speak up.

As a result of this, a number of people have been killed or injured
because of decisions that went the wrong way. They went the
nonscientific way. They went the way that the industry would have
preferred. Unfortunately, as the British Medical Journal said in a
recent article, asking the question, "Who owns the FDA?" I think the
answer is too much of the FDA is owned by the views and attitudes and
what's good for the pharmaceutical industry.


How does that happen? How is the pharmaceutical industry making its
inroads into the FDA? Where is it exerting its influence?

The pharmaceutical industry's influence gets exerted in a number of
ways. One, starting 10 years ago [with the Prescription Drug User Fee
Act of 1992], the influence was exerted by their directly funding,
paying cash right up front for FDA review. So in many ways, the FDA
started looking upon the industry as their client, instead of the
public and the public health, which should be the client.

A second way in which the industry influence occurs is by having
leaders in the drug division who are spineless and gutless, and who
don't like controversy. I have heard over and over again, directly
from these people, "Why can't this be settled on a scientific and
medical basis?" They don't like to take on the very awesome forces of
the drug industry and a lot of its indentured servants, so to speak,
in academic medicine. So the attitude by the leaders there [is],
"Avoid conflict" -- and avoiding conflict means doing what the
industry wants.

A third way in which the industry's influence has been allowed to grow
considerably is the absence of congressional oversight. Up until 12
years ago, whenever the FDA would make a mistake -- such as the series
of mistakes they've made in the late 1990s -- there would be a
congressional hearing. They would have to explain to the legislative
branch of the government what went wrong. They would be -- properly,
and in the best public health sense -- on the defensive to try and
explain what went wrong.

No one is there in the Congress [now]. There have been essentially one
or two days of oversight hearings in 12 years, as opposed to maybe the
previous 12 years with dozens and dozens of oversights. So they're
getting away with no congressional oversight.

Those are some of the reasons. And the culture at the FDA has become,
"Please the industry. Avoid conflict. Look upon our role as getting
out as many drugs as possible."

If the mistakes that the FDA were making were in the area of
lifesaving drugs that there wasn't any substitute for, where you would
say, "Yes, there's a risk, but you've got a benefit that clearly
outweighs it," that would be a whole different thing. It turns out
that the FDA's done a very good job with drugs that are truly
breakthrough [lifesaving] drugs. They've put them on a faster track,
and there really haven't been problems there.

The problems have all been with drugs where we already have 10-20
drugs, painkillers, on the market; where we already have ten or more
drugs, diabetes drugs, on the market. The drug in question, from the
start, in many cases, is not really a breakthrough. ...

So the FDA has gotten in trouble and gotten the American public's
health in trouble by a series of mistakes involving drugs that we
already have many other examples on the market that are just as
effective, just as safe or, in fact, as it turns out, safer.

The reason that we advise people not to use any new drug for seven
years, until it's been on the market for seven years unless it's a
breakthrough drug, is that the more recent drugs are much more likely
to have to get taken off the market or to have box warnings. The drugs
that have been on the market for a while, we know more about. They're
more reliable. Often, they're generically available and much less
expensive.

So the FDA seems to have made a number of mistakes in the area of
drugs that we really didn't need. Twenty years ago, if any of these
drugs such as Duract, Posicor, Rezulin, and a number of other of them
came on the market or came up for consideration with the kinds of
questions they had, the FDA's response would have been, "We're not
going to approve this drug. We're going to take a better look at
it."...


Why is it that these similar or "me-too" drugs -- the third or fourth
or tenth drug in a category -- why is it going to get into more
trouble? Why is it not going to get as serious a review? Why are those
drugs coming up with more problems?

Once the industry realizes that painkillers or diabetes drugs or high
blood pressure drugs are a lucrative market -- which they've known for
a long time -- they try and slice out another piece of it. If you're a
company that doesn't have a drug in that category -- "Hey, it's a $1
billion or $2 billion or $3 billion market, if we can just get a drug
in there" -- they obviously have to introduce something that is new.
Therefore, they have to develop a molecule that is at least slightly
different -- different enough to get a patent -- from the existing
drugs. In terms of effectiveness, it may well be that the drug is no
more effective. But just changing one or two little molecules may
impose a safety risk that wasn't present in the other drugs.

So one reason why some of these newer drugs in the me-too category are
more dangerous is the companies were manipulating the basic molecular
structure, and adding something that turned out to be more dangerous,
even though no more effective. ...


Twenty years ago, if a question came up about safety, it was much more
likely that the FDA would say, "No. Let's wait a minute. Let's get
more information." More recently, the scrutiny over drug safety has
weakened. In the study that we conducted of FDA physicians, they told
us in 1998, compared with several years before, the standards were
lower for safety and for effectiveness. In other words, the decision
to approve a drug was more lax, more risky in a sense, in the late
1990s than it had been even three or four years before. We focused on
those people that had been around long enough to be able to compare
what was going on then with what was going on earlier.

So if you relax the standards and don't pay as much attention to early
warnings about safety as you should, and if you relax the
effectiveness standards and say, "Well, the drug is only this much
better. It's statistically significant. Even though it might not be
clinically important, we'll still approve it," that's a real relaxing
of the effectiveness standards. If you relax both the safety standards
and the effectiveness standards, you're looking for trouble. And
that's what's happened.


Maybe this is going to come as a surprise to people. But I would
imagine, as most people do, that if a new drug is coming on the
market, it's got to be better and safer than other things that are
already there.

For close to 30 years, we have supported legislation that would say a
new drug cannot be approved unless there's evidence that it's either
safer and/or more effective than an existing drug. Such legislation
was strongly fought by the industry, and it's never passed. So right
now, if you want to bring a new drug to the market, you don't have to
even do a study to compare it to the state-of-the-art drug. You don't
have to show, head to head, that it's as effective or more effective.
And you don't have to show head to head that it's as safe or more
safe.


Therefore, FDA doesn't have the legislative authority to say no to
me-too drugs just because, as it turns out, it isn't any better than
an existing drug, which is most often the case. Of course, it's going
to be worse statistically, because we don't know as much about it as
we should. The older drugs have been around for a longer time. We have
not only the experience prior to approval, but we have thousands or
millions of people who've used them. We have a much better idea of
what to expect. That's not the case with a drug that is just coming on
the market.


Just to follow up on that -- I was told this morning at the Food and
Drug Administration that it's good that we have choices, that new
drugs open up the possibility that they're going to be the best thing
for some people. It's responsible to approve them, it's better to
approve them, and allow doctors to choose.

The party line from the pharmaceutical industry has been, "Doctors
should have as many choices as possible. New drugs, even if in the
same category, may be of benefit." It is interesting that to support
the British Medical Journal's contention that maybe the pharmaceutical
industry owns the FDA, the FDA itself is now spouting the same kind of
rhetoric.

If this were true, it should be able to be demonstrated in some kinds
of clinical studies. If it's just left to a fantasy, to a possibility,
that's not good enough. You need to have some kind of evidence that
the tenth drug in a category is actually going to be better than --
not just as good or worse than -- an existing drug. If the FDA doesn't
have the authority to demand these head-to-head studies, we're not
going to find that out until it's too late, until the drug has come on
the market.

So for an FDA official to say it's OK to keep approving more and more
and more me-too drugs in various categories because they may benefit
someone, that's not good enough. That's an anti-scientific,
anti-intellectual kind of statement to make. ...

Imagine being a physician or a reviewer at the FDA and hearing, as
someone will, their boss say, "Well, it's OK to approve these drugs,
because they may benefit someone." It's very demoralizing.

I mean, the morale at the FDA is the lowest I've seen in 31 years now.
The turnovers -- the FDA did its own study, which you probably have
seen, the summer of 2001, trying to find out why so many people were
leaving. Like the results of our study, they found that a number of
people are complaining about having their opinions overturned. These
are scientists, pharmacologists, physicians, and so forth.


What evidence is there that it's the pharmaceutical industry influence
that is changing these attitudes in the upper levels of management at
the FDA, that's overruling the scientists, that's putting the business
interests first?

The FDA is an agency of the Public Health Service. Its primary mission
is to improve the public health. You have to be very cautious when --
through a combination of being funded directly by the industry, as
opposed to through the U.S. Treasury, and congressional influences
which are pro-industry, as opposed to pro-consumer -- it starts moving
in a way that is very favorable to the industry.

The positive opinions of the pharmaceutical industry of the FDA have
never been higher than they were at least from 1997 to 2001. The last
year, they've been complaining a little, because there's been a
smaller number of drugs approved.

But one way of gauging how favorable the FDA is acting towards the
pharmaceutical industry is just to ask the pharmaceutical industry
what they think of the new FDA, the FDA from, let's say, 1995-1996
through 2000-2001. They love it. They gave a former FDA commissioner
an award for doing a terrific job. You would not have seen these
things 10-15 years ago, when the FDA was in an appropriately vigilant
and appropriately adversarial attitude with industry.

The FDA, obviously, has to work with the industry, and that's good.
But when the FDA starts getting taken over in many ways by the
industry, that's not good. In response to the questionnaire that we
sent out to the physicians at the FDA, they themselves told us that,
many times, they believe that industry influence was operating on the
people above them, and getting their bosses to overturn some of the
decisions that they had made against approving a drug.

So there are lots of sources of evidence about the fact that the
pharmaceutical industry has an almost unprecedented finger or thumb on
the FDA in the last few years, compared with any time in the past.


What does your organization do? ... What is it that the Health
Research Group does? Why are you in business? ...

I decided to start this group [31 years ago], largely to monitor the
Food and Drug Administration and the pharmaceutical industry. That's
been about two-thirds of the work we do. We also monitor occupational
health, worker health, and OSHA, put out some things on questionable
doctors, and so forth.

But the imbalance of power between the pharmaceutical industry and the
FDA has always been a problem. It's gotten much worse the last five or
six or seven years. But even in the better days, there was a need for
someone outside the government -- and, obviously, outside the industry
-- to raise questions, collect information, analyze data, and try and
get drugs taken off the market.

We've succeeded in getting 12 prescription drugs taken off the market
over these 20 or 30 years. We don't often ask the FDA, "Take a drug
off the market." When we do, it's only because we think the
information is crystal clear. We asked for Rezulin to be taken off the
market way before it was taken off the market. We asked for it to be
taken off the market, I think, in the summer of 1999. It wasn't taken
off the market for another year and a half.

So our job is to collect information free of the influence of the
pharmaceutical industry, or free of the often-negative influences of
the Congress, which sometimes pushes the FDA in the direction of the
industry, and take appropriate action. [That] means filing a formal
petition with the FDA asking them to ban a drug, put a warning label
on, and if they don't respond, suing them. We have a litigation group
which has gone to court many times to ask the FDA to take a drug off
the market. In a number of instances, we have succeeded. Usually, the
cases are not litigated, because the FDA backs off.

But the question is, why is it necessary for there to be a force
outside of the FDA, when the FDA has all the legal authority they need
to protect the public health? I think the answer is they aren't using
their legal authority. They are a cop with all of the law behind them,
but often intimidated by the pharmaceutical industry, and not using
the law to protect the public from a series of well-documented health
hazards.


Well, is that actually true? ... Does the FDA really have the
authority to keep drugs that are maybe marginal off the market? Isn't
there a standard? If it's better than a placebo, do they have the
capability? Does Congress need to tell them to do a different job?

.... Under existing law and regulations, FDA has shown a number of
times in the past that if there's a safety question about a drug or a
dose of a drug, they can say no to it. The companies may not like it,
but they have the authority to do that. If the companies object, the
information can possibly be made public, and the side of the FDA will
more likely prevail.

Just as in the 1980s and up to the mid-1990s the FDA did, in fact,
turn down a number of drugs, because they weren't necessarily any more
effective, and there were questions about safety. They could still be
doing that. It's a matter of law enforcement. The fact is that,
despite advice to the contrary by physicians at the FDA,
pharmacologists, advisory committees, they have gone ahead recently
and approved a number of drugs.

One of the drugs we're trying to get off the market now is a weight
reduction drug called Meridia, sibutramine. The physician in charge of
that drug at the FDA said it was too dangerous, [that] it shouldn't be
approved. The FDA advisory committee on that drug voted against
approving it. It was approved despite that, because there was a big
push to replace a recently banned diet drug, Fen-Phen,
dexfenfluramine, or Redux, the drug there. The FDA felt, somehow,
"Well, we've taken one away. We have to give them another," even
though the doctor at the FDA thought it was too dangerous, even though
the FDA advisory committee thought it was too dangerous.

The FDA does have the authority to say no much more often than they
have in the last five or six or seven years. The FDA would be helped,
however, if they did have the authority to impose massive civil
penalties on drug companies. There's nothing a drug company can do, no
matter how horrendous, that the FDA will fine it, because the FDA
doesn't have the legal authority to fine drug companies for anything
at all.

Another thing that would improve FDA's authority is if they could
actually say, when a new drug came along, "You have to provide us
evidence that this drug is safer and/or more effective than the old
drug, or we're just going to turn it down." They don't have that
authority right now. ...

So although FDA doesn't have the authority to require head-to-head
safety and efficacy studies on a drug, if it turns out that there is
some evidence, prior to approval, that the drug is more dangerous,
they can -- and have in the past -- say no. They just aren't saying no
often enough in the present.


If there's a drug that has some problems -- if you're seeing some
drugs that are coming up with adverse effects that weren't expected
that are very serious -- is it a reasonable approach to try to manage
that problem, to try to figure out a safer way to use that drug, maybe
through warnings of the risk to people who use it, or who prescribe
it?

Two answers required. We would prefer the use of risk prevention, if
possible, to risk management. Here's why. If there's some evidence of
a risk for a drug before it comes on the market, what should be done
is not to approve it. Management is not really the concept. It's risk
prevention by not approving the drug.

Once a drug -- let's assume a drug that there wasn't any information
prior to approval -- comes on the market, problems start arising. The
question is, what can you do to "manage the risk," other than just
take it off the market? If it's a drug for a life-threatening medical
condition, you'd like to keep it on the market. You'd like to do
whatever you can to retain it on the market.

The drugs that have gotten in trouble are mainly not lifesaving drugs.
They're drugs with lots of other ones around. FDA has an almost
unblemished record of failing to use risk management techniques, such
as warning labels, letters to doctors, box warnings, to take care of
these problems. In instance after instance, after a failed -- and
dangerously so -- risk management program, the drug comes off the
market. The question is, now that we have so much evidence from drugs
like Rezulin, drugs like Duract, drugs like Posicor, of failed
FDA-industry risk management attempts -- why bother trying those
again, particularly if the drug is not a unique drug?

The answer, again, should be [that] once enough evidence occurs prior
to marketing or afterwards that there's a problem, don't even pretend
to think that you can manage it by putting warnings out. Both the FDA
and our organization did a study showing that fewer than 5 percent of
the people who were getting Rezulin were getting the supposedly
correct number of liver studies to make sure that they weren't getting
toxicity. So it just doesn't work.

The concept of risk management, if it also includes risk prevention by
bans either before a drug comes on the market or shortly afterwards,
if there were evidence that that worked -- labeling changes, warnings
-- it would be one thing. But FDA knows from its own experience --
with failed attempts to manage risk by warning labels and box warnings
-- not to go that route, especially if it's a drug that really doesn't
offer any unique advantage.

Six or seven years ago, they might have said, "It's worth trying."
It's been tried. As a result of trying it and failing to accomplish
it, large numbers of people have been killed or injured for drugs that
should have been taken off the market sooner rather than later, when
they were taken off the market.


So risk management -- it's not good for consumers at all? It's not
good to try to figure out how to make a drug that's got some problems,
used more safely?

If the drug has unique advantage and is really saving lives, it's
definitely worth trying to figure out what you can do to keep it on
the market. But if the drug, as is much more often the case, is not a
uniquely advantageous drug, when the problem arises, it should be
dealt with definitively, and the drug taken off the market, rather
than pretending, contrary to all of the evidence of the last five or
six years, that you can actually manage the risk without taking it off
the market. ...


So how many people are coming from the FDA to work here? Why are they
doing that?

In the first 24 or 25 years of this group's existence, no one from the
FDA ever called and said, "I'd rather be working with you." Because
they thought that at least they could get some things done in the FDA.
Sometimes they would give us leads on things that we could follow up
on, although most of the efforts to ban drugs really came from our own
surveillance.

However, unlike the first 24 or 25 years, [in] the last six or so
years, there have been an unprecedented number -- as in more than zero
-- of FDA employees who have asked to work here.

I would say that, as of now, there have been about ten physicians or
other scientists in the FDA who have called and said, "I really would
like to leave the FDA, and work here." We don't have the funds. We
have three working, all on a part-time basis. All came from the drug
part of the FDA, which is the most demoralized part of the FDA right
now, I believe. All of them said, "We aren't able to do what we would
like to do at the FDA, because we are being squelched. We're being
ridiculed. We're being overturned in terms of our decisions. We would
like to come here, because you are free of those kinds of influences."

As a matter of policy, we don't take any money from the government. We
don't take any money from industry or any associations at all. So
people know, from our record, that we tell it like it is. We do very
careful research. A lot of it published in medical journals, and so
forth.

So I think that one of the symptoms of the demise, or at least the
retrenchment of the FDA from what it used to be, is this large number
of people, including one very recently who sent a resume, and said,
"Can I come and work here? I'm going to take early retirement from the
FDA."


We were just talking about some numbers here. Should we be alarmed at
the number of drugs that have been coming off the market in the last
few years? Or is it really no different than it's always been?

The absolute number of drugs that's come off the market in the last
five or six years is really much higher than any period of time. The
industry and its increasing friend, the FDA, try and say, "Oh, no.
What you really should be looking at is what percentage of the drugs
that we approved came off the market." From a public health
perspective, what really matters is how much damage is being done. The
more drugs that come on the market, and then have to be taken off the
market only after a lot of people are killed or injured really is a
measure of the total damage. So the total damage is really much higher
than it's ever been.

A recent study by the GAO, done at the request of some members of
Congress, showed that even more recently, the percentage of drugs that
is coming off the market is higher than it's been before.

But whichever way you look at it, the FDA is doing the worst job in
the drug safety area than they've done anytime in the past 31 years.
You hear this from employees at the FDA, some of whom are coming to
work here. Others of whom are just taking early retirement. A much
larger number are sort of biting their tongues, staying at the FDA,
even though they are not at all satisfied with how weakened the
standards for safety and effectiveness have become over the last five
or six years.


You mentioned the French system of Pharmacovigilance. ... In the
United Kingdom, in Great Britain, is there a better system as well,
compared to what we have here? ... What's the system in England?

In the United Kingdom, they have a system called the Yellow Card
system, where physicians who have patients who they believe have had
adverse drug reactions will fill out a yellow card, and send it in to
the government.

An interesting contrast between the British system and the American
system is that most of the adverse drug reactions that get reported to
the FDA come from the industry. They are required by law to report
these. We believe that the completeness or accuracy of a lot of these
reports is tainted, because they come from the industry. In Britain,
the overwhelming proportion of the adverse reaction reports come
directly from physicians, who do not have the financial incentives to
tilt the data in a way to make it look more favorable to the drug
company.

But even in the United States, experiments that have been tried to
increase the amount of adverse drug reaction reporting have worked --
and then they've been abandoned. When I was a resident back 35 years
ago, the Residents' Fund would get $20 or something like that every
time an adverse reaction was reported. It encouraged a lot of young
residents to report things, when they might not have otherwise. ...

A number of things that have been tried and worked, but then they've
been abandoned. So the United States knows exactly what to do if they
want to increase the number or rate of adverse reaction reports.

But equally important is, what do you do when you get those reports in
there? Do you take them seriously? Do you take the obvious and legally
mandated action to take a drug off the market? Or warn about it once
those reports come in there? That's what is going wrong as much as
anything at the FDA. Once all the work is done on these reports, they
don't go anywhere too often, and people suffer.


Can you just give me a basic description of the user fees? What's that
concept? How does it work?

For the first 86 years of FDA's existence, from 1906-1992, all of
FDA's funding came through the U.S. Treasury. In other words, everyone
-- industry-- People paid their taxes and FDA got appropriations out
of the budget.

Starting in 1992, unfortunately, a law was passed that said, for a
large proportion of the work done by the FDA on looking on new drug
applications, the money's going to come directly, quid pro quo, from
the industry. If they want a drug reviewed, they pay directly to the
FDA to have the drug reviewed.


This system has created a very unhealthy relationship -- even more
unhealthy than it used to be -- between the industry and the FDA,
where the FDA says, "We have to be nice to these people, because they
are paying our bills." It's developed an unhealthy sort of client
relationship between the government and the industry which, I think,
has resulted in some drugs getting approved that shouldn't; drugs
being put on a faster track than they should have.

I think that, in general, it's been a very bad idea. We strongly favor
ending this experiment, which has had, in the10 years that it's been
in existence, some of the worst things happen in terms of drug safety
we've ever seen. I think that's not the only explanation. But direct
cash funding from the pharmaceutical industry to the FDA turns out to
be a very bad idea.


This may be a personal thing, but I've heard a lot of people say, "Sid
Wolfe never saw a drug that he liked. He's just too negative to
evaluate drugs." What do you say to that?

For anyone to say that we are just totally negative about drugs, and
that we've never met a drug that we actually do like, is ridiculous.
They are essentially ignoring a large proportion of the work that
we've done over the last 31 years. Because the thing that most people
know us for, other than our work at the FDA to try and get drugs taken
off the market, are books called "Worse Pills, Best Pills." Now three
editions, 2.2 million copies sold, where for every drug that we say,
"This is the worst pill. It's dangerous," we say, "But here is a safer
alternative." So that book and a newsletter we put out accompanying
the book in between editions clearly says we have a long list of drugs
that we think are good, effective, and safer. They're often older
kinds of drugs.

So we have a much longer list of safer alternatives than we do of
dangerous drugs. That's not surprising. That's why we try and guide
people, if they'd need to take a drug, to take one that has more
benefits and fewer risks, rather than the worst pill that has fewer
benefits and more risks.


~~~~~~~~~~~~

For the dangers of Breast Implants, which Dr. Wolfe has strongly
criticized, please visit:

www.BreastImplantAwareness.org

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