One of the major expenses
of an IVF cycle is the cost of the gonadotropin injections
(menotropins) which are used for superovulation. Since
gonadotropins are natural hormones, they were formerly
manufactured by extracting and purifying them from the
menopausal women (urinary-gonadotropins), a relatively
inexpensive process. These urinary gonadotropins were
manufactured by 2 large multinational companies, Serono
and Organon, and these were marketed as Pergonal and
Humegon. Hundreds of thousands of babies were born with
the use of these medicines which were safe, effective
and inexpensive.
However, given the ever-increasing demand for these
products, these companies then decided to use modern
recombinant DNA technology to manufacture gonadotropin
injections (rec-gonadotropins). The products they market
are Gonal-F and Follistim.
While the good news was that this technology allowed
them to manufacture large quantities of pure HMG, the
bad news is that they became greedy. First, they withdrew
their inexpensive urinary gonadotropins from the market.
They did not do this to help infertile patients, but
to preserve their profits. They were worried that doctors
would continue to prescribe the older less expensive
effective products, as a result of which the market
share of their newer recombinant products (which were
much more profitable for them) would be much less!
To add insult to injury, they doubled the price of
the new gonadotropins. Even though the newer recombinant
products are no better than the older, tried and tested,
urinary products (as proven by many research studies
sponsored by the pharmaceutical companies themselves),
since this was an oligopoly, they could get away with
this.
Instead of looking after the interests of infertile
patients, they then spent millions of dollars marketing
the "new and improved" versions to doctors,
most of whom have now been brainwashed by clever advertising.
But aren't the recombinant products better
than the urinary products?
Better for whom ? Not for the patient, definitely !
I would be the first to agree that the recombinant products
are as good in clinical practise as the older products.
However, there is absolutely no evidence to show that
they are any better.
In fact, if you stop to think about it, it would be
very surprising if they were better. They were developed
as alternatives to the older products, and have been
shown to be as effective as them, which is what one
would expect. They are definitely better for the pharmaceutical
companies manufacturing them, because they are far more
profitable , since they have been over-priced.
What about the clinical studies?
All the studies have simply shown that they are as effective
as the older urinary products. In fact, this is what
the studies were designed to do, so that they could
get permission from the FDA to market the rec products.
Unfortunately, some marketing whiz seems to have got
the brainwave that the newer products should be presented
as being better - not just as being as good! They then
massaged all the data to try to show this - but have
failed to do so.
How cost-effective are the recombinant products?
If you calculate the dollar cost per baby born, since
the products are much more expensive as the older products,
they are much less cost-effective. They just represent
an unnecessary additional cost burden to infertile patients
- a burden most can ill afford to incur.
But the new products are pure FSH! Doesn't
this make them better?
The recombinant products contain only pure FSH, while
the urinary gonadotropins contain equal amounts of the
two gonadotropins, FSH and LH. However, there is no
evidence that using only pure FSH ( as compared to using
a mixture of FSH and LH) affects pregnancy rates. The
combination products have stood the test of time.
What about the studies which show a higher
pregnancy rate with the rec products?
It is true that pregnancy rates with IVF are now better
than they were in the past, and the manufacturers of
these products are happy to take the credit for this
improvement in pregnancy rates. However, this improvement
has been because of the improved lab conditions we now
provide in the IVF lab, not the medicines. Controlled
prospective studies which have compared the urinary
products with the rec products do not show any difference
in pregnancy rates.
What do you have against the recombinant products?
Nothing ! My only criticism is that the manufacturers
have become greedy, and are charging exorbitantly for
their products. This is a very unfair burden on infertile
couples. If they priced their rec products at the same
level at which they price their urinary products, I
would be very happy to prescribe them.
What can patients do?
Given the fact that the urinary products are as effective
as the recombinant products, request your doctor to
prescribe these for you. Even though Organon and Serono
have stopped manufacturing urinary gonadotropins, the
good news is that they are still being manufactured
by other multinational companies, such as Ferring. Ferring
manufactures Repronex , which sells for only US $ 30
in India ( versus US $ 55 in the USA)
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