Feds Cancel Study Comparing Breast Cancer Drugs
- From: J <nexsw@nvalid,anon>
- Date: Sat, 04 Aug 2007 15:57:31 -0400
<
http://blogs.wsj.com/health/2007/06/20/feds-cancel-study-comparing-breast-cancer-drugs/
June 20, 2007, 8:21 am
Feds Cancel Study Comparing Breast Cancer Drugs
Posted by Jacob Goldstein
The National Cancer Institute pulled the plug yesterday on a planned $100
million breast cancer study it initially endorsed, the Washington Post
reports. The study would have compared the effectiveness of two drugs ?
Eli Lilly?s Evista (known generically as raloxifene) and Novartis?s Femara
(letrozole) ? in preventing breast cancer in women at high risk for the
disease.
Evista, which is similar to the generic drug tamoxifen, has been shown to
reduce the risk of cancer in high-risk women. But it hasn?t been widely
used, partly because it can cause menopause-like symptoms, the Post
writes. Femara is a member of a newer class of drugs known as aromatase
inhibitors, which may be more effective at reducing the risk of breast
cancer.
An NCI committee reviewing the study came down against the trial, because
of its high cost and because two large studies comparing aromatase
inhibitors against placebo are already under way. The committee also
suggested that many women might choose not to use aromatase inhibitors
even if they were shown to be effective, because they carry risks of their
own, including causing brittle bones in some women.
Supporters of the canceled study faulted the decision. They argued it
would have been an important tool in determining the best drugs to prevent
breast cancer. ?We feel this trial is scientifically valid and one that
has the potential to impact the health of thousands of women in this
country and around the world,? said D. Lawrence Wickerham of the National
Surgical Adjuvant Breast and Bowel Project in Pittsburgh, which was
organizing the study.
Permalink | Trackback URL:
http://blogs.wsj.com/health/2007/06/20/feds-cancel-study-comparing-breast-cancer-drugs/trackback/
Save & Share: Share on Facebook | Del.icio.us | Digg this | Email This |
Comments
Kudos to NCI decision makers for asking the key question: Will results of
the research have a significant impact on decision-making? Looks like they
decided that if competing products each prove effective vs. placebo, then
there is room in the market for both, based on other patient factors?and
relative efficacy won?t be as important as those other factors often
enough to make the study worthwhile.
Comment by CR - June 20, 2007 at 10:30 am
With the amount of our tax dollars wasted on pointless studies, why not
fund something like this that COULD actually do some good?
Really, who cares about the mating habits of field mice, or age of the
earth when we have people dying from (hopefully) preventable or curable
diseases?
Comment by EEJ - June 20, 2007 at 11:45 am
$100 million is the amount which can help any African country to stand on
its feet.
$100 million can save thousands of poor with already determined and proven
medicines.
I think this is only one of the positive step that NCI has taken. There
are numerous high cost studies of similar nature that NCI should be giving
a second thought. There are numerous studies out there , which can
definitely help human kind in much larger number, that are waiting
funding.
Comment by JZ - June 20, 2007 at 12:07 pm
I have had breast cancer. My mother died of breast cancer. My sisters, my
nieces, and my granddaughters need a reliable way to reduce their risk of
breast cancer. Is $100 million dollars too much to help us decide which
drug is most effective in preventing breast cancer with the fewest side
effects? We set priorities every day, spend government dollars every day.
To me and to many other women who face breast cancer the P-4 prevention
study is a valuable use of those dollars.
Comment by Kate Murphy - June 20, 2007 at 12:20 pm
More chemotherapy is given for breast cancer than for any other form of
cancer and there have been more published reports of clinical trials for
breast cancer than for any other form of cancer.
According to the National Cancer Institute?s official cancer information
website on ?state of the art? chemotherapy for recurrent or metastatic
breast cancer, it is unclear whether single-agent chemotherapy or
combination chemotherapy is preferable for first-line treatment.
At this time, no data support the superiority of any particular regimen.
So it would appear that published reports of clinical trials provide
precious little in the way of guidance.
Comment by Gregory D. Pawelski - June 20, 2007 at 12:34 pm
As a woman who was a participant in the first two breast cancer
chemoprevention trials I feel extremely qualified to voice my opinion of
the cancelation of the STELLER Trial. This can only be described as a
travisty, nothing short of a national disgrace. The first trial proved the
usefulness of tamoxifen with a 48% reduction rate in the expected number
of breast cancer in the more then 13,000 high risk participants. The
second trial proved that raloxifene had an equal preventative effect with
fewer side effects. Given these findings, the NCI is signing the death
warrents of millions of women. My materal grandmother, my grandmother, my
mother and all three of her sisters died from breast cancer. My sister and
two cousins have by the grace of God survived it. What answers does the
NCI have for me???? NCI should be deeply ashamed of itself.
Comment by Olga Lois Wexler, Proud Participant - June 20, 2007 at 1:05 pm
I?m happy for your survival, Olga, but your experience as a survivor does
not qualify you to judge the merits of research which a panel of experts
have had the courage to name as ?not worth it.? It is certain that their
decision was made in context of knowing they would get flack, which makes
it all the more reasonable to assume that they are certain about the
uncertain value of the results.
It is important to note, that NOT following through with the study is NOT
going to keep anyone from being treated. Rather, the point was to
determine if one or the other treatments was so superior that it should be
given favor. Ultimately, NCI decided that the trial wouldn?t add
substantially to the knowledge already available through
placebo-controlled studies. That is it.
Comment by CR - June 20, 2007 at 2:14 pm
I would suggest the CR re-read my posting. I am NOT a survivor nor did I
claim to be. I have not had breast cancer. I said I was a participant in
the first two trials. That said, who better then me to judge the merits. I
have directly benefited from the trials. I have made a contribution.
Having taken part, having put my life on the line is an act that requirers
courage.
Comment by Olga Wexler - June 20, 2007 at 3:02 pm
Good move on the NCI. Big Pharma will fund and pay for the research if
they believe it is worth it and effective. How do you prove something
prevents any cancer when those who participate in the study don?t get
cancer (breast, prostate, colon, etc.) Just becuase they are in high risk,
the may not have gotten the disease any way. Also people in these kind of
studies get continual followup and monitored much more closely than the
general public, so precancerous or abnormalities are managed much earlier
on.
$100 Million would go a long way to providing mammograms, MRI, etc to
women who need them and can?t afford them. While these tests do not
prevent cancer, done on a regular basis for the right reason find it much
earlier, make it much more survivable and have proven to be an effective
use of federal funds.When the government spends billions on drug research
funding, the big pharma groups get the positive results and positive
revenue to the tune of $billions for little out of pocket expense.
As a wise old pharma CEO once told me, ?It is a proven fact that cancer is
the leading cause of research?
Comment by JT - June 20, 2007 at 3:22 pm
Sorry for misinterpreting your trial participation for something else,
Olga. Your participation still does not qualify you any more than driving
a car qualifies me to judge the merits of road construction projects.
My bigger point here is that testimonials are powerful, and powerfully
mis-used. Individual examples of miraculous cures or incredible suffering
are important to impart the human element on the analysis of data, but we
cannot be ruled by sentiment, no matter how compelling?not when it comes
to the investment of public health dollars, for which there is a
substantial opportunity cost every time.
Comment by CR - June 20, 2007 at 3:31 pm
CR
So true. I can sleep in the garage but that will not make me a 1967
Mustang Classic.
Comment by JT - June 20, 2007 at 4:02 pm
Well JT and CR both of you should read the Cancer Letter. It seems the
head of the NCI, Dr. Neiderhuber did exactly that. He depended upon a
breast cancer survivor organization to judge the merits of STELLAR! The
science of this trial is sound, live with it. It was peer reviewed and
approved and Dr.
Neiderhuber revoked the approval in an unprecedented, never before move.
Sound familiar? He is the great decider not unlike another person in the
DC area who bends the truth to fit his cause. The NSABP is the same
research organization that proved a woman could opt for breast conserving
surgery instead of a mastectomy. They have many, many years of quality
ethical research in their history; go ahead and check them out at
www.nsabp.pitt.edu Saving women?s breasts from a research study! What a
heresy! Would that you went after tobacco lobbyists the way you attack
clinical trial research.
Comment by Olga Wexler - June 20, 2007 at 4:44 pm
I?m sure the NSABP is a capable organization. And, I?m sure that NSABP?s
researchers were counting on the cancelled project to answer what they
believe to be very interesting questions. I?m also sure that the
cancellation of the research has NSABP?s CFO and member organizations
scratching their heads and wondering how they?ll adjust for the reduction
in revenue.
The core question that you seem to refuse to address is: Is the money
better spent on research that is clearly marginal at best?and apparently
not a good enough value to deserve funding? Or, should that money be spent
on other research that is of clearer value?perhaps research to prove the
efficacy of a new drug, or to substantiate off-lable use of an existing
treatment for another cancer to improve survival.
There is not bottomless bucket of research money. I?m glad NCI is
demonstrating an ability to make tough calls with what we do have.
Comment by CR - June 20, 2007 at 5:01 pm
I am a nurse who enrolled patients in the STAR study who were very
relieved that they were doing something to reduce their breast cancer
risk. I am also a breast cancer survivor - dxd at age 39. Granted, nobody
wants a premature menopause but absolutely nobody wants breast cancer
either. I would much rather deal with hot flashes and bone density tests
than to develop breast cancer if I had not already had breast cancer. The
more options women of all ages have to reduce their risk, the better.
Comment by RVG - June 21, 2007 at 4:28 pm
Great comments by great people on this page but I do have to say CR is a
wise person with some wise knowledge among all others on this blog. CR?s
points make sense than any other?s points. Few of the ladies here are
thinking that NCI has forgotten about women & breast cancer prevention and
has moved in a completely different direction. Well my dear ladies thats
not true ? NCI is always one step ahead in looking for better usage of
money. CR is right that NCI board gave a deep thought before making this
decision and the thought was given by the best in this field. We should
all understand if NCI had million of millions extra in hand they might
have not stopped this trial even if it was giving way less output benefit
but when the budget is limited than the wise decision makers in NCI board
has to find the best use of money for the benefit of all the nation ? and
preventing breast cancer is always their first priority. NCI board is all
specialized doctors and they know that Prevention is better than cure. I
trust NCI and I believe they made this decision for our benefit and we
should all trust and respect their decision.
Comment by JZ - June 25, 2007 at 12:57 am
.
- Prev by Date: Testicular cancer with bone metastasis
- Next by Date: Czech therapy - "devitalisation"
- Previous by thread: Testicular cancer with bone metastasis
- Next by thread: Czech therapy - "devitalisation"
- Index(es):
Relevant Pages
|
