This and the next two blogs are about
the newest statins in the PCSK9 class and put on limited use by the
FDA.
Amgen and Sanofi/Regeneron, the makers
of the two newly approved cholesterol drugs, evolocumab (Repatha) and
alirocumab (Praluent), are fueling an explosion of new programs to
identify large numbers of new patients who are candidates for the
expensive drugs.
An example is a $120 million
partnership between Regeneron and Geisinger Health System to broaden
the search for genes and drug targets well beyond familial
hypercholesterolemia, which is the main indication for PCSK9
inhibitors right now.
By comparing "genetic
information against medical histories, Geisinger and Regeneron hope
to eventually develop new means of diagnosing, preventing and/or
treating medical conditions -- before they cause significant harm.
Some participants may also receive information that could be useful
in their own medical care."
Peter Berger, MD, who recently became
the senior vice president of clinical research at the North
Shore-Long Island Jewish Health Care System made comments about the
two expensive drugs. Before that, he was at Geisinger, where he was
involved in the Regeneron negotiations, though he emphasized that he
was not speaking for Geisinger and he was not involved with the final
deal. Berger said that at North Shore-LIJ, his main concern is to
identify untreated patients who can benefit from treatment, patients
who's LDL is way too high on a statin.
Berger then stated, "Most
health care institutions, including my own, have too many patients
with very high LDLs (for example, greater than 400 mg/dl untreated,
or greater than 250 mg/dl on the maximal dose of a potent statin),
and do a poor job of screening the family members of such patients."
While it may not matter to the patient
what the actual cause of the high LDL is, all the medical people are
concerned about at this point is whether they can earn money for
getting these patients on the expensive drug. They will bypass any
nutritional help and recommend the drug.
“Berger said he reached out to the
companies to see if they would help explore the novel use of
informatics to help identify such high-risk patients and get them to
goal. He said he hopes to establish a program at North Shore-LIJ with
industry support to identify such high-risk and insufficiently
treated patients. Berger is keenly aware of the potential economic
impact of the PCSK9 inhibitors and said that the study he is
proposing contains an analysis of the economic impact of the drugs.
In fact, he said that the drug companies readily agreed that such an
analysis be a part of any study they fund.”
“Berger admitted, he was extremely
concerned about the price of drugs in general, including the PCSK9
inhibitors. The pricing of drugs in this country is obscene. In the
case of the PCSK9 inhibitors, I hope a third or a fourth PCSK9
inhibitor hits the market and drives the price down."
“But, he said, he's "not
concerned at all that by identifying and screening more patients we
will be expanding the pool for these drugs," as long as the
patients receiving such therapy are appropriately selected."
Berger emphasized that all such patients should be counseled about
the role of diet and exercise, but did acknowledge, however, that
intensive lipid lowering drug therapy is virtually always needed for
patients with LDLs in the 400 range.”
All I would add to this is that as long
as there is money flowing into his pocket, he will say and advocate
for anything.
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