| Lamplighter |
05-19-2013 03:11 PM |
Thoughts about $ and medical ethics
Here's an article filled with potential conflicts of interest and medical ethics
So put on your ethics hat and try to figure out what you think.
It's a rather long article and I have not tried to post all the issues,
but it involves:
* multiple for-profit pharmaceutical corporations,
* a well known not-for-profit (tax exempt) foundation,
* NIH grants of tax-payer $ for prior research and
* special grants of tax-payer $ for orphan diseases
* insider/private (?) employee stock trades
* foundation committees writing treatment guidelines for marketing
etc.
Milwaukee Journal Sentinel
MedPage Today
John Fauber, Reporter,
May 19, 2013
Cystic Fibrosis: Charity and Industry Partner for Profit
Quote:
When a disease-related charity becomes a venture capitalist,
count the pharmaceutical industry among the winners.
To illustrate, consider the 'breakthrough' cystic fibrosis drug
Kalydeco (ivacaftor), which is marketed by Vertex Pharmaceuticals.
Vertex developed the drug with the help of a $75 million investment from the Cystic Fibrosis Foundation
-- as well as a hefty investment from taxpayers through grants from the National Institutes of Health,
which underwrote the cost of early research, which identified the gene that the drug targets.
The Platinum Drug
When Kalydeco came on the market last year, it carried
one of the most expensive price tags of any medicine on the planet.
Then, thanks to some well-timed stock sales tied to two separate developments
involving the drug, executives of the company grossed more than $100 million
by cashing in stocks and stock options. At one point, the value of company's stock
increased more $6 billion in a single day.
Vertex Pharmaceuticals now is charging $307,000 per year per patient, for the drug.
Since it is based on a rare genetic mutation, the drug only helps 4% of those
who have cystic fibrosis, or about 1,200 people in the U.S.
<snip>
But David Cornfield, MD, a professor of pulmonary medicine
at Stanford University School of Medicine, said the financial arrangement
between the foundation and Vertex was "fraught with peril."
He said the foundation should not be financially benefiting at the expense of patients
Lisa Schwartz, MD, a professor of medicine at Dartmouth Medical School,
applauded the organization's work in funding development of the drug.
Ideally, she said, the money the foundation gets should be used to help
cystic fibrosis patients pay for their medications and manage their disease.
"It is concerning that the organization now stands to profit
when patients choose to use the drug," Schwartz said.
"Financial entanglement with industry, even with the best of intentions,
creates a conflict of interest."
<snip>
One highly effective "marketing" tool for therapeutics is to
have them recommended in a guideline.
Last month, new treatment guidelines for doctors treating cystic fibrosis patients
strongly recommended use of Kalydeco
-- the Cystic Fibrosis Foundation funded those guidelines.
Three of the 10 authors of the guidelines were employees of the Foundation
and four others worked for institutions that received grants from the Foundation,
according to CFF spokeswoman Laurie Fink.
She said the foundation routinely makes research and training grants to institutions.
"It is definitely a conflict of interest," said Eric Campbell, PhD,
an associate professor at Harvard Medical School who has researched
conflicts of interest in treatment guidelines.
In the past, drug companies have been criticized for funding treatment guidelines
that recommend their drugs. It is no different if the guidelines are funded by
a foundation that gets royalties from drug sales, Campbell said.
<snip>
Pfizer, the world's largest drug company, will be getting $58 million from the foundation
-- part of its royalty money from Vertex -- to help it develop other cystic fibrosis drugs.
Another $75 million will be going be going back to Vertex and
about $10 million to Genzyme, which is part of the global drug giant, sanofi-aventis.
<snip, snip, snip>
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