Half of all clinical trial delays are a result of patient recruitment problems. Imagine the struggle faced by researchers of rare diseases. In addition to the normal recruitment problems, as well as the standard 20-30% post enrollment dropout rate, they are working with very limited patient populations.
To get viable results for rare disease studies you need adequate participation. The problem is people receiving Supplemental Social Security income are not allowed by US law to accept compensation for research. Doing so makes them ineligible to receive government medical benefits and prevents them from participating in clinical studies. Take that limited pool of participants and make it smaller. Now find a cure. Good luck.
As of the end of September, over 100 patient, academic and industry organizations have joined to support legislation that enables individuals with rare diseases to participate in clinical trials without losing their eligibility for government assisted healthcare benefits. Some of these include the Cystic Fibrosis Foundation, Johns Hopkins Hospital, the National Health Council, PhRMA and the Yale University Medical College.
According to Robert Beall, PhD., President and CEO of the Cystic Fibrosis Foundation, “Clinical trials are critical for developing effective therapies for cystic fibrosis and dozens of other rare diseases. Quick passage of this bill by Congress will support life-saving research for many people in need.” (Medical News Today 9/29/09)
The bill was introduced into the Senate September 16th and is called “The Improving Access to Clinical Trials Act.”
“This bill allows patients with a rare disease to disregard up to $2,000 of compensation received for participation in a clinical trial in their SSI and Medicaid income calculations,” said Senator Inhofe. “Though it will have a negligible impact on the federal budget, it will make a dramatic difference in the lives of those who will gain access to potentially life-saving treatments by enrolling in clinical trials as well as all those in the future whose lives will be improved by the medical advances that arise from this research.”
Over 30 million Americans are afflicted with one of the roughly 700 existing rare diseases and it is estimated two new pathologies are described every week in medical publications.
To track the current status of this bill, please click here: http://www.govtrack.us/congress/bill.xpd?bill=h111-2866
Please feel free to let your elected House and Senate representatives know you support this bill. Their contact information can be found here: http://www.usa.gov/Contact/Elected.shtml
You can even Tweet your support!
Monday, October 26, 2009
Thursday, October 15, 2009
Is the "Pink" Message Getting To You?
Pink is hot right now. In case you have missed the signs: from pink gloves and sneakers worn by NFL players to the barrage of ads on the TV and radio, October is Breast Cancer Awareness Month.
According to the American Cancer Society, 194,280 Americans will be diagnosed with breast cancer this year and 40,610 will die from the disease. Studies show that women who undergo reconstructive surgery after a mastectomy experience better quality of life. Reconstruction boosts self-esteem, body image and sexuality. Not all women choose reconstruction but all women should at least be presented with the option.
This is not always the case. A recent study, published in the Journal of Clinical Oncology, compared breast reconstruction among white women, African American women, Latina women who were highly acculturated (integrated into American society) and Latina women who were less acculturated. Of the 806 women studied, 41% of white women, 41% of highly acculturated Latinas and 34% of African American women underwent reconstruction; whereas, only 14% of less acculturated Latinas did.
Study researchers, from the University of Michigan Comprehensive Cancer Center, found the lower rate was not due to lack of interest. More than half of the less acculturated Latinas responded they would have liked more information about reconstructive surgery. They also claim this group was less likely to report their surgeon explained reconstruction to them or referred them to a plastic surgeon.
The study recommends better efforts be made to present breast reconstruction options to all patients, including those who do not speak English. They plan to do further research to understand how language and cultural issues affect a women’s choice to undergo reconstructive surgery post-mastectomy.
In addition to understanding their reconstructive options, targeted breast cancer awareness messages need to be directed at minority ethnic groups explaining symptoms, availability of screenings and insurance coverage. Women diagnosed with breast cancer in its earliest stage have a 9 out of 10 survival rate beyond five years. For cancer in its latest stage that has metastasized to other areas of the body, this rate drops to 1 out of 10. As you can see, early detection is key to survival.
This month is all about breast cancer awareness. For early detection and better survival, let’s make sure the “pink” message gets to everyone!
For more information about breast cancer in English and Spanish, including screening, prevention and treatment options, please visit the National Cancer Institute website:
http://www.cancer.gov/cancertopics/types/breast
According to the American Cancer Society, 194,280 Americans will be diagnosed with breast cancer this year and 40,610 will die from the disease. Studies show that women who undergo reconstructive surgery after a mastectomy experience better quality of life. Reconstruction boosts self-esteem, body image and sexuality. Not all women choose reconstruction but all women should at least be presented with the option.
This is not always the case. A recent study, published in the Journal of Clinical Oncology, compared breast reconstruction among white women, African American women, Latina women who were highly acculturated (integrated into American society) and Latina women who were less acculturated. Of the 806 women studied, 41% of white women, 41% of highly acculturated Latinas and 34% of African American women underwent reconstruction; whereas, only 14% of less acculturated Latinas did.
Study researchers, from the University of Michigan Comprehensive Cancer Center, found the lower rate was not due to lack of interest. More than half of the less acculturated Latinas responded they would have liked more information about reconstructive surgery. They also claim this group was less likely to report their surgeon explained reconstruction to them or referred them to a plastic surgeon.
The study recommends better efforts be made to present breast reconstruction options to all patients, including those who do not speak English. They plan to do further research to understand how language and cultural issues affect a women’s choice to undergo reconstructive surgery post-mastectomy.
In addition to understanding their reconstructive options, targeted breast cancer awareness messages need to be directed at minority ethnic groups explaining symptoms, availability of screenings and insurance coverage. Women diagnosed with breast cancer in its earliest stage have a 9 out of 10 survival rate beyond five years. For cancer in its latest stage that has metastasized to other areas of the body, this rate drops to 1 out of 10. As you can see, early detection is key to survival.
This month is all about breast cancer awareness. For early detection and better survival, let’s make sure the “pink” message gets to everyone!
For more information about breast cancer in English and Spanish, including screening, prevention and treatment options, please visit the National Cancer Institute website:
http://www.cancer.gov/cancertopics/types/breast
Monday, October 12, 2009
Ayudame...
In your day to day conversations, when the subject of human trafficking arises, images of young girls on the streets of Japan or India probably cross your mind. What you may not realize is that human trafficking is alive and well right here in the United States. Cases of human trafficking have been reported in all 50 states, Washington D.C. and some US territories.
According to the US Department of State, an estimated 14,500 to 17,500 foreign nationals are trafficked into the US annually for the purposes of commercial sex and/or labor exploitation or domestic servitude. Traffickers use force, fraud and coercion to compel women, men and children to engage in these activities.
Most sources agree, the covert nature of the crime, relative invisibility of its victims and the extreme amount of under reporting of the crime, mean these numbers are probably low estimates. Our melting pot identity sets up the US to be a trafficking magnet with people commonly trafficked from East Asia, Central & South America and Eastern Europe.
The greatest challenge lies in reaching and identifying victims. More needs to be done to reach victims in their native language and increased cross cultural and linguistic training activities need to be provided for social workers, health care professionals and law enforcement workers. It’s great that there is a 24-hour hotline you can call for assistance, but if you are petrified and only speak Korean, will the English speaking person on the other end be able to help you?
Victims need to understand information about their rights and translation services need to be made available. In the time period between, October of 2000 and fiscal year 2007, the Department of Health and Human Services (HHS) certified 1,379 foreign national victims of human trafficking. Despite the fact that over 10,000 people are trafficked into the US every year, only hundreds are assisted. Clearly more effort needs to be made to reach the people that need our help the most.
If you suspect a trafficking crime or need help, please call the national 24 hour toll-free Human Trafficking Resource Center at: 1-888-373-7888.
According to the US Department of State, an estimated 14,500 to 17,500 foreign nationals are trafficked into the US annually for the purposes of commercial sex and/or labor exploitation or domestic servitude. Traffickers use force, fraud and coercion to compel women, men and children to engage in these activities.
Most sources agree, the covert nature of the crime, relative invisibility of its victims and the extreme amount of under reporting of the crime, mean these numbers are probably low estimates. Our melting pot identity sets up the US to be a trafficking magnet with people commonly trafficked from East Asia, Central & South America and Eastern Europe.
The greatest challenge lies in reaching and identifying victims. More needs to be done to reach victims in their native language and increased cross cultural and linguistic training activities need to be provided for social workers, health care professionals and law enforcement workers. It’s great that there is a 24-hour hotline you can call for assistance, but if you are petrified and only speak Korean, will the English speaking person on the other end be able to help you?
Victims need to understand information about their rights and translation services need to be made available. In the time period between, October of 2000 and fiscal year 2007, the Department of Health and Human Services (HHS) certified 1,379 foreign national victims of human trafficking. Despite the fact that over 10,000 people are trafficked into the US every year, only hundreds are assisted. Clearly more effort needs to be made to reach the people that need our help the most.
If you suspect a trafficking crime or need help, please call the national 24 hour toll-free Human Trafficking Resource Center at: 1-888-373-7888.
Friday, October 2, 2009
I Am How I Feel
Our previous blog recounted a study that showed educational cues incited better vaccination habits in women versus emotional consumer ads or government mandates. In this study, education served to motivate better than emotion. Does that mean we should discount the effect emotion has on our identity and thus decisions we make about our health?
It’s true. Culture has a big impact on our perception of the world. However, can feeling emotionally good or bad make you act outside your cultural norms? Scientists decided to put this theory to the test and discovered that indeed, emotion has an effect on your cultural identity.
A journal article entitled, “Who I Am Depends on How I Feel: The Role of Affect in the Expression of Culture” outlines these results in Psychological Science. Scientists recruited volunteers from opposing cultural identities: Westerners, noted to value individuality and independence and East Asians who culturally value harmony and community. Then the unconscious tinkering began. To lift their mood they played upbeat music (Mozart), had them hold pens in their teeth (it force a smile). To bring them down they played Rachmaninov and had them hold the pen in their lips (forcing a frown).
Volunteers would then take a test to check for individualistic or group values: for example, given a choice of five pens, one red, the rest blue, which one would they pick? According to their stereotypical cultural values, the Western recruits should go for the red pen and the East Asian recruits should choose from the blue.
Their results were consistent in all the tests. Feeling good results in volunteers acting more exploratory and out of character whereas feeling badly reinforced cultural stereotypes and thought patterns. East Asians acted more independently and Westerners became more communal.
The researchers suggest “these experiments demonstrate a robust moderation of the expression of culture by affective state.” While past studies have shown culture can predict responses based on affect, this study shows it also works in reverse: affect can determine one’s expression of culture.
They also suggest, “Who one is-one’s behaviors, cognitions and self-construals-at any given point in time depends on the fundamental interplay between affect and culture.
Good to know.
By Sherry Dineen
It’s true. Culture has a big impact on our perception of the world. However, can feeling emotionally good or bad make you act outside your cultural norms? Scientists decided to put this theory to the test and discovered that indeed, emotion has an effect on your cultural identity.
A journal article entitled, “Who I Am Depends on How I Feel: The Role of Affect in the Expression of Culture” outlines these results in Psychological Science. Scientists recruited volunteers from opposing cultural identities: Westerners, noted to value individuality and independence and East Asians who culturally value harmony and community. Then the unconscious tinkering began. To lift their mood they played upbeat music (Mozart), had them hold pens in their teeth (it force a smile). To bring them down they played Rachmaninov and had them hold the pen in their lips (forcing a frown).
Volunteers would then take a test to check for individualistic or group values: for example, given a choice of five pens, one red, the rest blue, which one would they pick? According to their stereotypical cultural values, the Western recruits should go for the red pen and the East Asian recruits should choose from the blue.
Their results were consistent in all the tests. Feeling good results in volunteers acting more exploratory and out of character whereas feeling badly reinforced cultural stereotypes and thought patterns. East Asians acted more independently and Westerners became more communal.
The researchers suggest “these experiments demonstrate a robust moderation of the expression of culture by affective state.” While past studies have shown culture can predict responses based on affect, this study shows it also works in reverse: affect can determine one’s expression of culture.
They also suggest, “Who one is-one’s behaviors, cognitions and self-construals-at any given point in time depends on the fundamental interplay between affect and culture.
Good to know.
By Sherry Dineen
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