Pharma uses press to attack cost regulations in UK
How pharma attacks
cost regulations UK through corporate media
Comments below and the article are illustrative
of how
pharma works the media to promote their cancer treatments.
As Prof. Ben Goldacre said, “The devil is
in the
details.” In this case 3 standard
practices by pharma are at the core of NICE (UK drug regulatory agency for
their managed healthcare service). All
are glossed over in the pro-pharma article. Pharma does marketing studies which
are designed to make to outcome of the clinical trial produce results that are
better than the real-world outcome. This
is accomplished in several ways: 1)
by
selecting a population who will respond better to the treatment than those in
the population that will be treated with a different drug. 2) In this heads-on-trial comparing to
another treatment, that other treatment is administered in a way that is less
than ideal to reduce its effectiveness.[1] 3) By under-reporting side effects. 4) By counting only cancer deaths rather than
total deaths (in this case Kadcyla increase heart attacks and liver failure). They then
work the press to promote their cause and pressure NICE to do what isn’t in the
public’s interest. For example
Roche
selects a breast cancer patient to give press interviews about how she have
been denied life-saving treatment by NICE (but it isn’t life-saving, only
extending by 4 months). This interview
is reinforced by a patient advocacy group such as the National Cancer
Association (which just so happens to receive over half it’s funding from
pharma). Finally the article does
indicate how this overpriced drug will cause pain in death by its impact upon a
limited budget. Most likely Roche
ghost
wrote the article and distributed to the press who does makes it seem like they
got it from a reporter assigned to write on Kadcyla.
It’s all scripted tobacco (marketing) science;
scripted to make NICE appear to cause great harm. So what is left out in the
scripted
article: The harm that comes from the
dozens of other drugs whose cost would entail cuts in budget for essential
health care. Would the patient wish to
live an extra 4 months with terminal cancer made all the worse by the Kadcyla’s
liver toxicity and anemia and at the expense of a patients immobilized by
arthritis and in pain while they wait years for a hip-replacement operation
(assuming that was the consequence of the budget adjustment for Kadcyla). Lives
are lost because cuts will come to
preventive care programs. Nice figured
that for each sick year
of life the cost is $278,963. Is
one year consisting of 4 months for 3 patients dying of cancer worth that? Second,
the drug is made to seem more
effective than the market trial reveals.
Compared to another treatment, patients lived 30.9 vs 25.1 months. This duration was longer than the typical
one-year survival for metastatic patents because they included in the clinical
trial those who had aggressive non-metastatic breast cancer. Third, that in
the trial 43% of patients had
severe toxic reaction to the drug. Since
Roche ran the trial and owns the results, Roche did not release figures on
other causes of death. So why is it
approved in the US and E.U.? It is time
that we pass a law against price gouging.
The press says NICE allows patient to die because of budget constraints;
but more people would die if NICE allowed Kadcyla to force budget cuts. Price
is a grievous issue in 3rd
world countries, for which like with NICE pharma demands their pound of
flesh. More government in the corporate
interest, and a press sides with pharma. Pharma should be equated with
Shylock.
[1] Common ways are select a drug for cancer
that is not very effective, to administer a low dose, to administer the drug in
a form that is less effective. A couple
of examples will suffice, low dose aspirin is used to show that as an
anticoagulant Warfarin and Plavix are more effective. CoQ10 is administered
in the crystalline form
which has only a 10% absorption rate, this was done in Parkinson trial. To administer
niacin in the day when it is
effectively only at night in lowering cholesterol and free fatty acids. Niacin
has a half-life of 20-45 minutes,
unlike the 14 hours of Lipitor statin. Half-life is how long ½ the drug will
remain
in the patient.
http://www.fiercepharma.com/story/nice-rejects-roches-hot-new-breast-cancer-drug-kadcyla-then-invites-negotia/2014-04-23?utm_medium=nl&utm_source=internal
NICE
rejects Roche's hot new breast cancer drug Kadcyla, then invites negotiations
Patient group says it
will pressure government to pay
April 23, 2014 |
By Eric Palmer
Let the games begin. More
precisely, let the price negotiations begin, the top executive for the U.K.
price watchdog suggested today after the agency nixed Roche's ($RHHBY)
pioneering breast cancer drug Kadcyla as too expensive.
This could get interesting. That
is because the antibody-drug conjugate for treating HER2-positive metastatic
breast cancer carries a price that the National Institute for Health and Care
Excellence (NICE) doesn't
want to pay but is a drug that patients and doctors very much want to use.
"A breast cancer treatment
that can cost more than £90,000 [$151,000] per patient is not effective enough
to justify the price the NHS is being asked to pay," NICE said in a
statement.
"We had hoped that Roche
would have recognized the challenge the NHS faces in managing the adoption of
expensive new treatments by reducing the cost of Kadcyla to the NHS," Sir
Andrew Dillon, NICE chief executive, reiterated.
Roche countered, dinging the
price protector by pointing out that Kadclya was the eighth consecutive
treatment for advanced breast cancer to be rejected by NICE since 2011.
"Roche is extremely disappointed that NICE has failed to safeguard the
interests of patients with this advanced stage of aggressive disease,"
said Jayson Dallas, general manager of Roche Products. Roche has
told Pharmafile that as a treatment until the disease progresses, trials
indicated an average use of 9.6 months at a cost of around £44,310
($74,405).
Kadcyla, the first armed-antibody
treatment for breast cancer, was only introduced into the U.K. in February, but
according to a recent report, in the first 9 months since its approval in the
U.S, it is being prescribed by more than 80% of oncologists. As Pharmafile points
out, the antibody,
trastuzumab, binds to the HER2-positive cancer cells and is believed to block
signals that spur the cancer cells' growth. After the cancer cells absorb the
drug, it releases the DM1 to destroy them.
And patients in the U.K. want access to it, giving Roche more leverage
on price. "Kadcyla is a very impressive drug that has been shown to extend
life by up to 6 months in HER2-positive secondary breast cancer patients, and
with more manageable side effects than alternative drugs," Dr. Caitlin
Palframan, senior policy manager for Breakthrough Breast Cancer, said in a
statement today. She said that the U.K.'s approval process is not keeping up
with the pace of drug development and suggested that the group would be putting
pressure on the government to do something about it.
The treatment is being paid for
already through the government's special Cancer Drugs Fund. It would get wider
use and generate more revenues for Roche, however, if it were approved by NICE
for use throughout the National Health System. NICE invited comments by May 19
and then will publish a second draft. Many companies do return with discounts,
but because those negotiations and the final price are not publicized, it is
never clear who caved the most on their position.
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