Chemotherapy is one of the most common treatments for cancer.
Chemotherapy is one of the most common treatments for cancer.

How effective exactly is it for improving survival and quality of life?
How effective exactly is it for improving survival and quality of life?

This video, and the next, will answer those questions.
This video, and the next, will answer those questions.

"How Effective Is Chemotherapy?"
"How Effective Is Chemotherapy?"

Over the next few decades, the number of new cancer cases
Over the next few decades, the number of new cancer cases

will continue to skyrocket. Are we winning the war on cancer?
will continue to skyrocket. Are we winning the war on cancer?

Sadly, in general, no,
Sadly, in general, no,

this despite the introduction of hundreds of new anticancer drugs.
this despite the introduction of hundreds of new anticancer drugs.

The war on cancer has been likened to the war on terror.
The war on cancer has been likened to the war on terror.

No matter how many drone strikes you do, it's nearly impossible
No matter how many drone strikes you do, it's nearly impossible

to kill all the bad guys, and no matter how precise the bombing,
to kill all the bad guys, and no matter how precise the bombing,

one must always consider the collateral damage.
one must always consider the collateral damage.

The toxicity from cancer therapy can be debilitating,
The toxicity from cancer therapy can be debilitating,

and not just health-wise. There's also the "financial toxicity."
and not just health-wise. There's also the "financial toxicity."

Patented anticancer drugs are priced at up to
Patented anticancer drugs are priced at up to

nearly a thousand dollars a day.
nearly a thousand dollars a day.

Even with health insurance, the average cost to patients
Even with health insurance, the average cost to patients

for stage IV breast cancer, for example, can run $190,000.
for stage IV breast cancer, for example, can run $190,000.

It's bad enough to be fighting for your life without bankrupting
It's bad enough to be fighting for your life without bankrupting

your family at the same time – a problem still common to this day.
your family at the same time – a problem still common to this day.

Who can forget the apocryphal story of Walter White, working two jobs
Who can forget the apocryphal story of Walter White, working two jobs

with health insurance and still could not afford the cancer care?
with health insurance and still could not afford the cancer care?

Now, not everyone is willing to start their own meth lab,
Now, not everyone is willing to start their own meth lab,

but many are willing to go for broke.
but many are willing to go for broke.

A large proportion of cancer patients reported their willingness
A large proportion of cancer patients reported their willingness

to declare bankruptcy or sell their homes to pay for treatment.
to declare bankruptcy or sell their homes to pay for treatment.

I mean, look, aren't the high prices justified if new and innovative
I mean, look, aren't the high prices justified if new and innovative

treatments offer significant benefits to patients?
treatments offer significant benefits to patients?

But you may be shocked to find out that many
But you may be shocked to find out that many

FDA-approved cancer drugs may lack clinical benefit.
FDA-approved cancer drugs may lack clinical benefit.

Well, then how did they become FDA-approved?
Well, then how did they become FDA-approved?

Most approvals of cancer drugs are based on flimsy
Most approvals of cancer drugs are based on flimsy

or untested surrogate endpoints,
or untested surrogate endpoints,

and postmarketing studies rarely validate the efficacy and safety
and postmarketing studies rarely validate the efficacy and safety

of these drugs on patient centered endpoints.
of these drugs on patient centered endpoints.

Let me explain what that means.
Let me explain what that means.

New chemo drugs are increasingly approved just based on
New chemo drugs are increasingly approved just based on

so-called surrogate endpoints, which means instead of looking at what
so-called surrogate endpoints, which means instead of looking at what

we really care about — survival or quality of life — they approve
we really care about — survival or quality of life — they approve

drugs based on things like response rate, tumor shrinkage.
drugs based on things like response rate, tumor shrinkage.

But who cares if a tumor shrinks if it doesn't actually extend
But who cares if a tumor shrinks if it doesn't actually extend

your quantity or quality of life?
your quantity or quality of life?

It's kind of counterintuitive, but just seeing a tumor shrink
It's kind of counterintuitive, but just seeing a tumor shrink

on a CT scan or MRI is not necessarily correlated
on a CT scan or MRI is not necessarily correlated

with improvements in survival or symptoms.
with improvements in survival or symptoms.

In fact, most studies that have actually followed people out
In fact, most studies that have actually followed people out

found low correlations with survival.
found low correlations with survival.

The most recent comprehensive analysis found 90% of studies
The most recent comprehensive analysis found 90% of studies

of such validation trials found little correlation with overall survival.
of such validation trials found little correlation with overall survival.

Of 36 new chemo drugs approved by the FDA based on these kind
Of 36 new chemo drugs approved by the FDA based on these kind

of surrogate endpoints, once they were actually
of surrogate endpoints, once they were actually

put to the test in the real world,
put to the test in the real world,

only 1 in 7 was actually shown to extend life,
only 1 in 7 was actually shown to extend life,

and half explicitly flopped,
and half explicitly flopped,

and the rest remain untested, revealing that most cancer drug
and the rest remain untested, revealing that most cancer drug

approvals have not been shown to, or do not, improve
approvals have not been shown to, or do not, improve

clinically relevant endpoints.
clinically relevant endpoints.

Exorbitant drug prices are bad enough for treatments that work,
Exorbitant drug prices are bad enough for treatments that work,

but charging vulnerable patients for drugs without evidence that
but charging vulnerable patients for drugs without evidence that

they actually improve patients survival and quality of life
they actually improve patients survival and quality of life

is unconscionable.
is unconscionable.

Why doesn't the FDA require proof that chemo drugs
Why doesn't the FDA require proof that chemo drugs

actually benefit patients before approving them?
actually benefit patients before approving them?

Drug companies say that requiring randomized, controlled trials
Drug companies say that requiring randomized, controlled trials

with meaningful measures would take too long,
with meaningful measures would take too long,

but the study time reduction using surrogate endpoints
but the study time reduction using surrogate endpoints

rather than overall survival is estimated at just 11 months.
rather than overall survival is estimated at just 11 months.

So instead of it taking 7.3 years to come to market on average,
So instead of it taking 7.3 years to come to market on average,

it would take 8.2 years.
it would take 8.2 years.

Yes, look, we want to get these drugs out as soon as possible,
Yes, look, we want to get these drugs out as soon as possible,

but only if they're actually going to help people.
but only if they're actually going to help people.

Do cancer drugs improve survival or quality of life?
Do cancer drugs improve survival or quality of life?

You don't need to know, according to our broken regulatory system.
You don't need to know, according to our broken regulatory system.

And things aren't much better over in Europe.
And things aren't much better over in Europe.

A systematic evaluation of chemo drug approvals showed
A systematic evaluation of chemo drug approvals showed

that most entered the market without evidence of benefit
that most entered the market without evidence of benefit

on survival or quality of life.
on survival or quality of life.

And even years later, there was still no conclusive evidence
And even years later, there was still no conclusive evidence

that these drugs offered any benefit, and when they did,
that these drugs offered any benefit, and when they did,

the gains were often marginal.
the gains were often marginal.

That's why you see editorials in the Journal of the
That's why you see editorials in the Journal of the

National Cancer Institute referencing Hans Christian Andersen,
National Cancer Institute referencing Hans Christian Andersen,

the author of the tale of "The Emperor's New Clothes."
the author of the tale of "The Emperor's New Clothes."

The studies all converge on a singular conclusion:
The studies all converge on a singular conclusion:

only a minority of new cancer drugs approved by US and European
only a minority of new cancer drugs approved by US and European

regulatory authorities in recent years deliver clinically meaningful benefits
regulatory authorities in recent years deliver clinically meaningful benefits

to patients. In fact, some cancer- related deaths may be hastened,
to patients. In fact, some cancer- related deaths may be hastened,

or even caused, by the toxic effects of chemotherapy
or even caused, by the toxic effects of chemotherapy

rather than the cancer itself.
rather than the cancer itself.

Based on a review of tens of thousands of cancer patients, in as many as 27%
Based on a review of tens of thousands of cancer patients, in as many as 27%

of cases the cancer treatment itself caused or hastened death.
of cases the cancer treatment itself caused or hastened death.

Okay, but it might be worth that risk if the potential benefit
Okay, but it might be worth that risk if the potential benefit

is large enough. And that's the subject of my next video,
is large enough. And that's the subject of my next video,

"How Much Does Chemotherapy Improve Survival?"
"How Much Does Chemotherapy Improve Survival?"