Name: Podcast: How Effective Is Chemotherapy?
Uploaded: 2022-11-10T19:47:35.000Z
Duration: 13 min 27 s
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Well, today we're going to give you more power

Did you know that most chemotherapy drugs

are approved by the FDA without evidence of benefit

on survival or quality of life? Here's our first story.

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

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

this despite the introduction of hundreds of new anticancer drugs.

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

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,

one must always consider the collateral damage.

The toxicity from cancer therapy can be debilitating,

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

Patented anticancer drugs are priced at up to

Even with health insurance, the average cost to patients

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

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.

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

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

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

A large proportion of cancer patients reported their willingness

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

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

treatments offer significant benefits to patients?

But you may be shocked to find out that many

FDA-approved cancer drugs may lack clinical benefit.

Well, then how did they become FDA-approved?

Most approvals of cancer drugs are based on flimsy

and postmarketing studies rarely validate the efficacy and safety

of these drugs on patient centered endpoints.

New chemo drugs are increasingly approved just based on

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

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

drugs based on things like response rate, tumor shrinkage.

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

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

on a CT scan or MRI is not necessarily correlated

with improvements in survival or symptoms.

In fact, most studies that have actually followed people out

The most recent comprehensive analysis found 90% of studies

of such validation trials found little correlation with overall survival.

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

of surrogate endpoints, once they were actually

only 1 in 7 was actually shown to extend life,

and the rest remain untested, revealing that most cancer drug

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

Exorbitant drug prices are bad enough for treatments that work,

but charging vulnerable patients for drugs without evidence that

they actually improve patients survival and quality of life

Why doesn't the FDA require proof that chemo drugs

actually benefit patients before approving them?

Drug companies say that requiring randomized, controlled trials

with meaningful measures would take too long,

but the study time reduction using surrogate endpoints

rather than overall survival is estimated at just 11 months.

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

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

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

Do cancer drugs improve survival or quality of life?

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

And things aren't much better over in Europe.

A systematic evaluation of chemo drug approvals showed

that most entered the market without evidence of benefit

And even years later, there was still no conclusive evidence

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

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

National Cancer Institute referencing Hans Christian Andersen,

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

The studies all converge on a singular conclusion:

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

regulatory authorities in recent years deliver clinically meaningful benefits

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

or even caused, by the toxic effects of chemotherapy

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.

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

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

"How Much Does Chemotherapy Improve Survival?"

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Podcast: How Effective Is Chemotherapy?

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