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Old 05-19-2013, 03:11 PM   #1
Lamplighter
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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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Old 05-19-2013, 07:08 PM   #2
JBKlyde
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I'm a lab rat I do Lab Rat addition... I don't like having to be on pills, but if it's necessary I guess I just don't have much of a choice... I'm not a doctor so I'm just gonna let the doc do his job... you want to talk about making the star wars program work and see if we can open up a path to enlightenment by using the force I might have a few Ideas about that.
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Old 06-28-2013, 06:35 PM   #3
Lamplighter
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This article has nothing to do with $ (yet), but it is medical ethics and public opinion...

CBS News
Michelle Castillo
June 28, 2013
Philadelphia girl recovering after second lung transplant
Quote:
A Philadelphia girl who successfully sued in order to be put on the adult
lung transplant list is now recovering after receiving a second lung transplant.

It's unclear at this time if the second donor was a juvenile or an adult.
<snip>

Sarah's case isn't over yet though.
On Monday, she'll have diaphragm placation surgery to flatten
the dome her of diaphragm so her lungs will be able to expand further.
Currently, her diaphragm has been partially paralyzed because of lung transplant surgery,
and she was unable to have her breathing tube removed earlier this week as a result.
I'm not posting this as any sort of argument against any (lung or other organ) transplants.
But instead because the public Comments to this CBS News article are quite vehement and telling...
Quote:
Two potentially life savings (adult) lungs, potentially down the drain,
and two more adults waiting or dead because of it.
I am not insensitive to the situation and am thankful
I am not in the mothers shoes, but this hardly seems fair.
Also, this little girl has a progressive disease and a dim chance of living a long, productive life.
Quote:
So the doctors were right in the first place.
The first set of lungs were wasted and most likely these two will not work either.
Then when the options finally run out or the politicians finally stay out of it
or this little girl dies in the OR, the parents will sue.

Maybe instead they need to read When Bad Things Happen To Good People and learn to accept reality.
These people have been asking for prayers and insist they have faith.
Maybe they need to understand their prayers were answered and the answer was no!
Quote:
Starting to have a hard time rooting for this family.
Maybe the courts and approved physicians who declared the law
they fought so hard to beat to get the lung had a good reason
for putting the law into effect in the first place.
My own feelings are closer to this one...
Quote:
Arthur L. Caplan, director of the division of medical ethics at NYU Langone Medical Center,
previously added that while the judge's decision was a "reasonable compromise,"
not every medical case should be decided by the courts.
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Old 07-03-2015, 12:12 AM   #4
Lamplighter
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Quote:
Originally Posted by Lamplighter View Post
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

So now comes the second chapter in this saga....

Are risks worth the rewards when nonprofits act like venture capitalists?
The Washington Post - Brady Dennis - July 2,2015
Quote:
By the late 1990s, the Bethesda-based Cystic Fibrosis Foundation had spent decades
searching for ways to alter the course of the deadly lung disease. Ö

But frustrated that no game-changing treatments were in sight,
the groupís leaders in 1999 placed what many considered a risky bet,
deciding to invest millions of dollars in a small California biotech firm.

Robert J. Beall, the foundationís president, believed that putting money into drug companies directly,
rather than merely making grants to academic investigators,
might persuade the industry to focus on the disease and turn research into real-world treatmentsÖ

That initial bet, which over time grew into a $150 million investment, has paid off in a big way.

And last fall, the CF Foundation sold its rights to future royalties from the drugs for $3.3 billion,
the largest windfall of its kind for a charitable organization.<snip>

Venture philanthropy has its skeptics, who argue that patient groups risk harming their reputations
and their bank accounts by forming partnerships with the drug industry.
Some experts worry that the relationships create inherent conflicts of interest
and that nonprofits could allow financial motives to undermine their primary mission of putting patients first.

[Examples are:]
Multiple Myeloma Research Foundation<snip>
The Leukemia & Lymphoma Society <snip>
Juvenile Diabetes Research Foundation<snip>

Some bets donít pay off.
The CF Foundation has invested nearly $450 million in several dozen companies
over time as part of its venture philanthropy efforts.
Some projects have ended in disappointment, and others probably will, too, Beall said.
But to him, the risks are worth the potential rewards.
<snip>
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Old 07-03-2015, 09:49 AM   #5
xoxoxoBruce
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Quote:
And last fall, the CF Foundation sold its rights to future royalties from the drugs for $3.3 billion, the largest windfall of its kind for a charitable organization.
How does that contribute to affordable treatment for patients? Sounds to me like the foundation is just another piece of the big fuck you that is health care in this country.
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