Secrets of the FDA Revealed
by Top Insider Doctor
According to the Journal of the
American Medical Association (JAMA), "Adverse drug reactions are the
fourth leading cause of death in America. Reactions to prescription and
over-the-counter medications kill far more people annually than all
illegal drug use combined."
Annually, drug companies spend
billions on TV commercials and print media. They spend over $12 billion a
year handing out drug samples and employing sales forces to influence
doctors to promote specifically branded drugs. The drug industry employs
over 1,200 lobbyists, including 40 former members of Congress. Drug
companies have spent close to a billion dollars since 1998 on lobbying. In
2004, drug companies and their officials contributed at least $17 million
to federal election campaigns.
To get a full diagnosis of this
provocative story, highly acclaimed health guru Gary Null sent his lead
investigator and director of operations, Manette Loudon, to Washington,
D.C. to interview Food and Drug Administration (FDA) employee and Vioxx
whistleblower Dr. David Graham. What you are about to read may leave you
questioning the safety of all drugs, but it is a story that must be told.
Unless Congress steps up to the plate and changes policy at the FDA,
millions more will become unwitting victims of adverse drug reactions from
Graham, it's truly a pleasure to have the opportunity to interview you.
Let me begin by asking you how long you've been with the FDA and what your
current position is?
Dr. David Graham:
I've been with the FDA for 20 years. I'm currently the Associate
Director for Science and Medicine in the Office of Drug Safety. That's my
official job. But when I'm here today I'm speaking in my private capacity
on my own time, and I do not represent the FDA.
We can be pretty certain that
the FDA would not agree with most of what I have to say. So with those
disclaimers, you know everything is OK.
November 23, 2004 (during the) PBS Online News Hour Program, you were
quoted as making the following statement: "I would argue that the FDA as
currently configured is incapable of protecting America against another
Vioxx. Simply put, FDA and the Center for Drug Evaluation Research (CDER)
are broken." Since you've made that statement, has anything changed within
the FDA to fix what's broken and, if not, how serious is the problem that
we're dealing with here?
Since November, when I appeared before the Senate Finance Committee and
announced to the world that the FDA was incapable of protecting America
from unsafe drugs or from another Vioxx, very little has changed on the
surface and substantively nothing has changed.
The structural problems that
exist within the FDA, where the people who approve the drugs are also the
ones who oversee the post marketing regulation of the drug, remain
unchanged. The people who approve a drug when they see that there is a
safety problem with it are very reluctant to do anything about it because
it will reflect badly on them. They continue to let the damage occur.
America is just as at risk now as it was in November, as it was two years
ago, and as it was five years ago.
that same PBS program, you were also quoted saying, "The organizational
structure within the CDER is currently geared towards the review and
approval of new drugs. When a serious safety issue arises at post
marketing, the immediate reaction is almost always one of denial,
rejection and heat. They approved the drugs, so there can't possibly be
anything wrong with it. This is an inherent conflict of interest."
Based on what you're saying it
appears that the FDA is responsible for protecting the interests of
pharmaceutical companies and not the American people. Do you believe the
FDA can protect the public from dangerous drugs?
Dr. Graham: As
currently configured, the FDA is not able to adequately protect the
American public. It's more interested in protecting the interests of
industry. It views industry as its client, and the client is someone whose
interest you represent. Unfortunately, that is the way the FDA is
Within the Center for Drug
Evaluation and Research, about 80 percent of the resources are geared
towards the approval of new drugs and 20 percent is for everything else.
Drug safety is about 5 percent. The "gorilla in the living room" is new
drugs and approval. Congress has not only created that structure, they
have also worsened that structure through the PDUFA, the Prescription Drug
User Fee Act, by which drug companies pay money to the FDA so they will
review and approve its drug. So you have that conflict as well.
did that go into effect?
The Prescription Drug User Fee Act came into play in 1992. It was passed
by Congress as a way of providing the FDA with more funds so that it could
hire more physicians and other scientists to review drug applications so
that drugs would be approved more quickly.
For industry, every day a drug
is held up from being marketed, represents a loss of 1 million to 2
million dollars of profit. The incentive is to review and approve the
drugs as quickly as possible, and not stand in the way of profit-making.
The FDA cooperates with that mandate.
what about those new drugs? Are they any better than what already exists
on the market?
It's a myth that is promulgated not only by industry but also by the FDA
itself. It's a misperception that our lawmakers in Congress have as well
and they've been fed this line by industry.
Industry is saying there are
all these lifesaving drugs that the FDA is slow to approve and people are
dying in the streets because of it. The fact is that probably about
two-thirds to three-quarters of the drugs that the FDA reviews are already
on the market and are being reviewed for another indication.
So, for example, if I've got a
drug that can treat bronchitis and now it's going to be used to treat a
urinary tract infection, well, that's a new indication. But it's the same
drug and we already know about the safety of the drug. There is nothing
life-saving there. There is nothing new. There is nothing innovative.
A very small proportion of
drugs represent a new drug that hasn't been marketed before. Most of those
drugs are no better than the ones that exist. If you want to talk about
breakthrough drugs -- the ones that really make a difference in patients'
lives and represent a revolution in pharmacology -- we're talking about
maybe one or two drugs a year. Most of them aren't breakthroughs and most
of them aren't life-saving, but they get treated as if they were.
you at liberty to discuss some of the problems your colleagues are finding
with other drugs and if so, how widespread is the problem?
I'm really not at liberty to talk about things that pertain to my official
duties at the FDA. I can talk in my private capacity, but I can't talk
about material that would be confidential.
What I can say is that there
are a number of other scientists within the FDA who have also worked with
drugs that they know are not safe, even though the FDA has approved or
allowed them to remain on the market. They face some of the same
difficulties that I do. The difference is that either the problem isn't as
serious in terms of the numbers of people that were injured or that it's a
fatal reaction -- they're not willing to expose themselves to retaliation
by the FDA -- and retaliation would surely follow