Monthly Archives: April 2006

Clinical Trials: Patients’ Right to Know Results

It has been a quiet week on the cancer news front, which gives me an opportunity to discuss a question that has been on my mind since I first read an opinion piece in our journal Cancer recently.


 


The question is simple: Do patients and their families have the right to know the outcomes of clinical trials in which they participate?


 


According to a highly regarded cancer researcher, the answer is not so simple, and is essentially “no.”


 


I don’t agree.


 


Actually, to be honest, it is a position that has never crossed my mind.  My assumption has always been that, for most clinical trials, if you agree to participate you should know the results.  Short, simple and to the point.


 


There are different types of clinical trials underway in cancer treatment.  Some are prevention trials with fairly safe, well known drugs (although the recent Vioxx situation has many folks wondering how safe is safe).  Other trials are treatment trials, perhaps where two known accepted treatment regimens are compared to each other.  Other trials may compare a new drug or treatment program to an accepted, standard therapy.  The most … Continue reading →

A New Era for Breast Cancer Prevention?

This has turned out to be a more interesting day than initially planned.


 


We received notification late Friday afternoon that the National Cancer Institute and the National Surgical Adjuvant Breast and Bowel Project were going to release the results of their Study of Tamoxifen and Raloxifene (STAR) trial that had started in July 1999 and included almost 20,000 women.


 


The results were released at a news conference at 2PM this afternoon.  According to the presenters at the press event, raloxifene was the superior medication to prevent breast cancer in women at high risk.  I was quoted by one reporter as suggesting that I did not agree completely with that assessment.


 


The trial was designed to answer the question whether raloxifene (commonly known as Evista, which is in wide use for the treatment of osteoporosis in post-menopausal women) was as effective as an older drug called tamoxifen in reducing the risk of developing breast cancer in post-menopausal women at high risk.


 


Tamoxifen and raloxifene are both drugs which belong to a class of medicines called SERMS.  These drugs have both estrogen and anti-estrogen like effects in the body.


 


While raloxifene is effective … Continue reading →

Estrogen and Breast Cancer: Not What We Expected

You can’t always get what you want
But if you try sometimes you just might find
You get what you need
 
                                                –Rolling Stones

 


For years, we have had many studies that implicated hormone replacement therapy (HRT) with estrogens in increasing the risk of breast cancer in post-menopausal women who took them for relief of menopausal symptoms and other medical problems facing older women.

 

The Women’s Health Initiative, which has been the topic of several of my blogs including one I have posted recently, put to rest many of the myths about the medical values of HRT. 

 

The initial report of the portion of the study that treated some women with combination therapy with the hormones estrogen and progestin clearly showed an increased risk of breast cancer.  It also demonstrated increased difficulty in detecting those cancers at an early stage due to increased breast density which interfered with the interpretation of mammograms.

 

At the same time, there was a parallel study underway which was evaluating the use of estrogen treatment alone for women who had a prior hysterectomy (combination therapy is used in women who still have their uterus in place, since the progestin has
Continue reading →

Hormone Therapy, Race, and Breast Cancer Risk

One of the serious problems we have to confront in medical research is the fact that much medical research and investigation has been focused predominantly on white men. 


 


Over the past several years, as recognition of this problem has increased, more attention has been paid to including women and people of color in various clinical research programs.


 


The implications are significant, because we are now have less confidence that something discovered to work in white males or white men and women applies to other ethnic groups the same way.


 


One recent study that has received wide attention and has had significant impact is the Women’s Health Initiative (WHI).   This study, which reported several years ago on the significant medical risks of hormone replacement therapy in women, resulted in a significant decrease in the use of hormone pills in post-menopausal women. 


 


One key observation from the WHI study was that women who took combination hormone replacement therapy with estrogen and progestin had a higher incidence of breast cancer, especially if they had taken it recently over a long duration.  Subsequent reports indicated that in women who had a prior hysterectomy and only took estrogen as … Continue reading →

It’s Springtime, So Let’s Discuss Vitamin D

Springtime is here, and so once again is Vitamin D.


 


You may remember it was about a year ago when a lecture given at the American Association of Cancer Research annual meeting stirred considerable interest when the story was picked up by an astute Associated Press reporter.


 


By May, the newswires, television, and other media were awash with stories that we needed to get more sun to increase our stores of Vitamin D, and reduce our risk of cancer among many other maladies.


 


The fear among many of us was that the story would get muddled, and that a considerable amount of effort that has gone into cancer prevention relative to excess sun exposure would go by the wayside as everyone headed to the beach to increase their vitamin D, their tans, and their sunburns.


 


The main problem was that aside from a handful of advocates, there weren’t many in the scientific and medical community who were prepared to respond to these proclamations, some of which came from recognized and highly regarded researchers.


 


In short, we didn’t have a very clear and cohesive message to tell you what to do, how to do it safely, … Continue reading →