Drop by Drop Page #5

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and begin sublingual

immunotherapy

if it isn't covered

by insurance.

So you have each side not

wanting to take the first step,

because of their own issues,

both being in a sense,

somewhat financial.

Sublingual immunotherapy

has never really been

gone through some of

the rigorous studies.

There are more

studies being done.

The US

government looked into

which works better,

drops or shots.

And, like pretty much everything

that the government does,

they say, okay, we need

to continue to study this.

What's important is they found

almost the same level of

effectiveness for both of them.

They couldn't decide.

What's really important here

is that they couldn't say

that drops doesn't work

and that shots work.

They say, well, they

both seem to work.

Over the years, the

sublingual immunotherapy,

some of the problems have been

in the scientific studies,

you couldn't see the

biological markers

as we knew more about

what immunotherapy did,

but I think as we

move into another era,

you're gonna see that some

of that will be validated.

Oftentimes,

an insurance company's

not gonna cover

the allergy drops,

and one of the big

reasons for that,

probably the biggest

reason for that,

is because a lot of

insurance companies

base what they reimburse

on Medicare rules,

and back in the

1990's, Medicare ruled

that drops are not safe

and they're not effective.

- We have shared our protocol.

You know, we have an

extensive 130 page protocol

that explains

where it came from,

how the mechanism

works, everything,

with the FDA, with the leaders,

with the presidents

of the college

and academy and

whatnot, and yeah,

all of that information

that we've provided

has really gone without

really being looked at,

at least to our knowledge,

and we're not quite sure why

but there's been research

studies that have been started

and whatnot and the

invitations that we've had

to be involved in those have

been few and far between,

but we've initiated a lot of

our own research to do that.

Now, there's so much

scientific evidence

that shows this works.

The older doctors

seem to be hesitant

to make any changes

in how they do things,

but I'm seeing a real change

in the younger doctors.

They're still at a

stage in their lives

where they can

look for themselves

and say, oh, well, indeed

this is safe and effective.

Why aren't we doing this?

So I think part of it

is we have to just hope

the older people are not

in positions of power.

So we did a Freedom

Of Information request

to find out what is the basis

that the FDA has

allowed allergy shots.

We wanna know how do

they know that they work,

why are they FDA approved

and drops aren't,

and what we ended up finding is

it's called the Summary

Basis of Approval,

or why they approved

it in the first place.

I did this for all five major

pharmaceutical companies

that have allergy extracts,

and all the Summary Basis of

Approvals said the same thing.

Because there are no adequate,

well-controlled trials

with this product

to prove efficacy,

efficacy means does it

work, the optimal treatment

must be based on the clinical

response of each patient.

So, what they're saying is it's

based on patient to patient.

None of them have had to

do the types of studies

that the FDA now

demands of drops.

We then turned to

the FDA and asked,

okay, why did you

approve something

that there was no well-controlled

study to approve?

And their response

made total sense.

Allergy shots were proved

back in the 1920's,

and you didn't

actually have to prove

how well any of

your products worked

to the federal

government until 1962,

and after that got

passed, the FDA has since

been trying to make the shots

meet their current standards

and they've done study

after study in the 80's,

some shots are not

available anymore,

but you can actually still watch

the advisory committee hearings

where all these allergists

get together and talk

about whether or not

the FDA should approve

stuff, and they're seeing

that the shots don't meet

the current standards

but they know the shots work.

Once these are

taken off the market,

the road back is very difficult.

It's not gonna be

the same standards,

and I think once our extract

is removed from the market,

it will be years, likely,

before we have that

available again

and I think there's

a real possibility

of taking a step

backward in terms of

our clinical care

that we can offer

to patients and to the public.

And it's just like,

you know, drops work

but they aren't even in

the discussion really

for FDA approval, and you

can hear them talk about

how they don't wanna

get rid of these shots

because they know

these extracts work,

but they also know

that they don't meet

the current FDA standards, so

there's a lot of nuances here.

You can actually even

hear one guy ask,

so, since sublingual drops

are the same thing as shots,

can companies also just

get grandfathered in

and we can start using that?

Quite a few clinical

studies now evaluating rules

for certain various aspects of

sublingual and oral therapy.

As one of these studies actually

verifies an extract

as showing efficacy.

I hate to simplify

it, but essentially,

what they say is they have

to start from the ground up

and do these well-controlled

studies and meet the standards

since it's a different way

of taking the treatment.

I don't know what the FDA

approves or doesn't approve.

I do know that this

is the same stuff

that they approved for

giving it to me in the arm,

so I don't see

why they can't say

sublingual is just

another alternative way

of delivering the same product.

For our

investigation, we asked

three of the pharmaceutical

companies that make extracts,

if they ever wanted

to get approval

for their stuff to

be used as drops.

You know, did they ever

try and it just failed?

We wanted to know, and

Allergies Laboratory, Inc. said

they have never pursued it.

Greer said they are

planning to do it,

and ALK totally

ignored the question

and responded by telling us

about their brand new pill

that you can put

under your tongue

if you're allergic

to grass or ragweed.

- This was recently approved

through the FDA in this country.

It's been approved in

Europe for about 10 years.

These sublingual

tablets, they're actually

a form of immunotherapy,

right now approved

for only grass and

ragweed in this country,

and they've been show to

be effective for those two

if you have patients who are

only sensitized to those two

so that's kind of our

treatment options we have.

The most important

development has been

the release of the grass

and ragweed tablets

that treat a single allergen,

allergy, if you will,

and that has really

kind of awakened

the notion and

interest in sublingual,

even more than was there before.

For my patients as a whole,

it really doesn't matter

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