In the early 1960s,
the pharmaceutical company behind the drug thalidomide
tried to convince Dr. Frances Kelsey,
a scientist from the Food and Drugs Administration
to approve their drug.
A stubborn stickler of a medical officer
in the Food and Drug Administration, Dr. Frances Kelsey.
She refused to approve sale of the drug in the United States.
Thalidomide was eventually blamed
for causing birth defects in tens of thousands of children
around the world,
with many more dying at birth.
Thanks to the diligence of Dr. Kelsey and the FDA,
children in the US were spared.
The FDA has a tough job:
it needs to ensure that drugs are safe.
The decisions it makes are life-altering,
in most cases for the best.
But not always.
FDA failures have been blamed for contributing to the opioid epidemic
and giving false hope to Alzheimer’s patients
by approving a costly and unproven drug.
This is, in fact, a tremendous controversy
in the scientific and medical world.
Unlike the time when Dr. Kelsey worked at the FDA,
the federal agency is now much cozier
with the industry it is supposed to regulate—
pharmaceutical companies with lots of money
and questionable practices,
from lobbying...
Drug companies and the insurance companies
have spent $4.5 billion
on lobbying and campaign contributions.
to advertising...
Ask your doctor if Myrbetriq is right for you.
and price gouging.
Everybody’s doing it.
In capitalism, you try to get the highest price
that you can for a product.
Today, the FDA’s mission is more critical than ever.
I’m still not completely 100 percent sold on the inoculation.
Wake up, New York!
So why is the FDA making these costly mistakes,
endangering public trust?
We will not comply!
This is how the FDA
needs to do a better job at protecting Americans
from the greed of some pharmaceutical companies.
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In 1995,
Purdue Pharma released a powerful pain medication called OxyContin,
downplaying the drug's addictive properties.
Less than 1 percent of patients taking opioids
actually become addicted.
Since then...
more than half a million people
have died of opioid-related overdoses in the US.
Can you breathe? Can you hear me, honey?
Miss, wake up.
Thousands of lawsuits have been filed against Purdue Pharma
and other opioid makers.
The global settlement, announced today,
involves the company pleading guilty to three felony counts
for defrauding the United States.
But the FDA has escaped much of the blame.
Had the Food and Drug Administration done its job properly,
I don’t believe that the United States
would be in the midst of an epidemic of opioid addiction.
OxyContin’s misleading label, which downplayed the risk of abuse,
was approved by the FDA.
Purdue Pharma used this seal of approval
to aggressively market the drug as safe and effective for chronic pain.
I had a daughter who was prescribed OxyContin,
and she died as a result.
She had a backache, and her doctor prescribed it.
Had FDA enforced the law,
Purdue never would have been allowed to promote its products
for these conditions.
Since I’ve been on this new pain medication,
I have not missed one day of work,
and my boss really appreciates that.
As a result, opioid prescriptions surged.
Why didn’t the FDA do a better job at safeguarding American lives?
Why the FDA failed is difficult to say.
You know, doctors across the country
were hearing that patients are suffering needlessly
because of an overblown fear of addiction,
and the compassionate thing to do
is to prescribe opioids more aggressively.
They don't wear out. They go on working.
They do not have serious medical side effects.
It’s possible that some of the FDA officials
were influenced by this same campaign,
a campaign promoted by the pharmaceutical industry,
so maybe you could give some of these officials the benefit of the doubt.
In 2002, as the dangers of OxyContin became clearer...
Eventually, it stopped working.
It was probably the most...
unbelievable, excruciating, horrible time in my life.
a meeting was held at the FDA to review the labeling of opioids.
And at that meeting, the FDA really could have taken the right steps.
But instead we saw FDA go in the opposite direction—
it began approving a steady stream of new opioids.
It’s really hard to give FDA the benefit of the doubt
because it was very clear that we had an emerging public health crisis
caused by these drugs.
The majority of advisors at this meeting
had ties to pharmaceutical companies,
including Purdue Pharma.
Unlike Dr. Kelsey, some FDA officials
had allowed themselves to be swayed
by the industry it was supposed to be regulating.
The relationship between the FDA
and the regulated pharmaceutical industry changed
with the introduction of the Prescription Drug User Fee Act
back in 1992,
a law passed by our Congress
in which the industry started funding the agency that reviews this drug.
FDA went from an agency
that was supposed to really police this industry
to an agency that would need to provide the industry
with good customer service.
One FDA official who helped approve OxyContin
went on to work for Purdue Pharma on a $400,000 a year contract,
and he hasn't been the only one.
I think we do need to do something about the revolving door.
In other countries,
regulators are not able to go from a regulatory agency
to working for the same regulated entities.
This summer,
the FDA gave the green light to a new Alzheimer’s drug.
To the potential breakthrough in the battle against Alzheimer’s.
On the market at $56,000 a year,
there is little evidence the drug, Aduhelm, actually works.
Well, I’m a former chair
and current member of the FDA Advisory Committee
that reviewed this product.
When we looked at all of the information,
we simply felt that there was not sufficient evidence
to get this product across the line.
While the FDA usually rules in line with its advisory committee,
in this instance, it didn’t.
And the next news I heard was that the FDA decided to approve it.
It's an historic day for the company,
and I want to applaud the amazing job made by all my colleagues.
Biogen staff had worked hard to get this drug approved.
In 2019, a number of Biogen’s clinical trials were aborted.
The clinical trials failed to show that the drug works
in terms of improving cognitive benefit,
and that really should have ended it.
But it didn’t.
Some Biogen staff began to organize unofficial meetings with the FDA.
In June, July, and August of 2019,
the FDA team and the Biogen team met or communicated almost daily.
The interactions were just inappropriately close.
And with that effort, they resurrected the drug
and submitted it to the FDA for approval.
Once again, the pharmaceutical industry
had succeeded in winning over FDA officials.
Essentially, the FDA rescued this product from the jaws of defeat.
Close interactions between the FDA and the companies it regulates
are allowed.
But despite growing concerns,
politicians haven’t taken steps to limit these.
Congress has encouraged those interactions,
again through various laws passed over the last three decades.
The problem is
the pharmaceutical industry is a big gorilla.
We’re not taking it on because of the political muscle of Pharma
and the pharmaceutical companies.
So FDA isn’t alone in responsibility for where we are.
Today, there are three pharmaceutical and healthcare lobbyists
for every member of Congress.
Since 1998, big drug companies spent nearly $4 billion on lobbying.
On behalf of Big Pharma,
these lobbyists have successfully weakened the FDA.
Members of Congress who pass legislation
at the behest of industry lobbyists that weaken the agency.
One night I got home from work,
and someone from the FDA called me.
He was very angry with me
because I was sending these emails to the FDA Attorney General.
And he yelled into the phone,
“We don’t have the manpower to police Purdue Pharma.”
That’s when I started realizing
Purdue Pharma had overwhelmed the FDA.
Shame on Sackler!
Attempts have been made to hold Big Pharma to account.
In 2007, Purdue Pharma pleaded guilty to federal criminal charges
for downplaying OxyContin’s addictive properties.
We hope that Purdue’s guilty plea will send a message
that the Department of Justice will not allow Big Pharma
to engage in illegal conduct
that corrupts the doctor-patient relationship.
But unlike those who sell drugs on the street,
money has kept the Sackler family, who own Purdue Pharma, out of jail.
They hired the Giuliani firm.
Guess what? They didn’t go to jail.
Just paid some fines.
Purdue Pharma was recently dissolved in a bankruptcy settlement.
Purdue has declared bankruptcy, but the Sackler family has not.
They took $10 billion out of the company
before it declared bankruptcy.
Purdue Pharma and the Sacklers
aren’t the only ones in the industry driven by greed.
How did the drug improve?
If I were to look at a pill and analyze it from 2005,
when it cost $215,
and if I looked today when it costs $763,
would that pill be the same?
The pill, the manufacturing for it would be the same.
It makes me feel really bad
because I’d hate for my daughter
to have to hear about her mom dying from an overdose.
Millions of families continue to be devastated by the opioid epidemic.
I would challenge anyone right now
to say that they do not know a friend, neighbor, or family member
who has not been affected.
And many more are worried about
the impacts of the FDA’s approval of Aduhelm.
Approval of a drug like this that hasn’t been shown to work
is going to raise false hopes for millions.
I see patients with Alzheimer’s disease,
and I feel palpably the urgency that patients and their caregivers have
to have new products on the market.
But that unmet need shouldn’t drive reductions
in the evidence bar required to get to market.
Many also fear knock-on implications.
One reason that that some people say they’re hesitant for the vaccine
is they don’t trust the FDA in doing its job,
which is really unfortunate in the case of COVID-19 vaccines
because there, in contrast to Aduhelm,
we have an enormous amount of evidence
that the drugs are highly effective and are very safe.
And we will not be forced to take your deadly vaccine!
Yeah!
Today, American distrust of pharmaceutical companies
is at an all-time high.
It’s more important than ever
for the public to feel that the agency is on their side.
The FDA has an important but tough job.
There’s an enormous volume of evidence
that the FDA has to wade through.
And I have the privilege to work with the FDA,
and I know how hard they work on behalf of the American people.
But some of the FDA’s decisions
are upsetting those working within the agency, too.
A third FDA advisor has now resigned
after the approval of Biogen’s Alzheimer’s drug.
In July, the FDA called for a federal investigation
into the way that Aduhelm was approved.
Many individuals who work at FDA today
who truly believe in the agency’s public health mission
are frustrated by an agency
that too often puts the pharmaceutical industry’s interests
ahead of public health.
Today, the FDA is at a crossroad
as President Biden is due to name a new head for the agency.
We need a new commissioner,
a new leader at the head of the organization,
that is pro-public health.