It is becoming more common for clinical trials to be conducted outside of the United States and for the subsequently approved medications to be used in the United States.
As a practicing physician in the United States, I believe medical care in this country is superior to anywhere else in the world. Of course, if you look at statistics such as infant death rates at birth, we continuously rank lower than some countries in Western Europe. But, on the other hand, if we were to just compare ourselves to our northern neighbor, Canada, and consider how long prostate cancer and breast cancer patients have to wait for their surgeries or imaging studies in that country, we are still providing our patients with excellent care.
Moreover, we have always been proud of our research and development (R&D) efforts in this country, and we still have the most advanced R&D programs in the world. Having been involved with clinical research day to day for more than 10 years, I certainly enjoyed the privileges of practicing with the most advanced treatments in dermatology, such as biologics, oncology treatments, even lasers and other medical devices.
Trials Conducted Outside the United States
I recently noticed that outsourcing clinical research to mostly Eastern European countries is happening, where the regulations are much looser and there is a lack of oversight. According to the Inspector General’s report, 80% of the applications submitted to the FDA for a new drug application in 2008 had been from trials in foreign countries. We are witnessing more and more clinical trial data from overseas.1
The best example of this in dermatology is calcipotriene 0.005% betamethasone dipropionate 0.064% (Taclonex). This ointment is approved by the FDA for use in the US, with 100% of the data that led to its approval coming from foreign countries.2 We all know it is cheaper to run studies where the local population lives under difficult conditions. It is easy to recruit patients in poor countries compared to the US.
Regulations are easier to handle, not heavily enforced and certainly beyond the reach of FDA monitoring outside of the United States. The FDA visited only 45 of the 6,485 locations where foreign drug studies were being conducted.1
Dangers Associated with A Lack of Oversight
Finally, malpractice and litigation concerns are not as much of an issue when conducting clinical trials outside of the United States. The potential exploitation of research subjects is a reminder of what happened in this country during the infamous Tuskegee syphilis experiment, where subjects were neither told they had syphilis nor were they ever treated for it.3 This led to the 1979 Belmont report and the establishment of the Office for Human Research Protections.4,5 In 2007, in a similar occurrence, homeless subjects were given money to take part in a flu vaccine experiment in Poland. While they thought they were getting a regular flu shot, they were not, and 20 of the participants died.
The clinical development program has been the basis of the excellent medical care we provide in this country. Unfortunately, it is difficult for me not to think about how Taclonex ointment was developed each time I prescribe it. I am afraid this impetus of shifting clinical trials overseas may lead to us losing the foundation of our superior medicine.
Dr. Kircik is an Associate Clinical Professor of Dermatology at Indiana University Medical Center. His is also the Medical Director of Derm Research, PLLC, and Physicians Skin Care, PLLC, in Louisville, KY.
Disclosure: Dr. Kircik has no conflicts of interest to report in relation to the content of this column.
References
1. Bartlett DL, Steele JB. Deadly medicine. Vanity Fair. January 2011.
2. Kragballe K, van de Kerkhof PC. Consistency of data in six phase III clinical studies of a two-compound product containing calcipitriol and betamethasone dipropionate ointment for the treatment of psoriasis. J Eur Acad Dermatol Venereol. 2006;20(1):39-44.
3. Centers for Disease Control and Prevention. The Tuskegee timeline. https://www.cdc.gov/tuskegee/timeline.htm. Accessed April 24, 2013.
4. Katz RV, Kegeles SS, Kressin NR, et al. The Tuskegee legacy project: Willingness of minorities to participate in biomedical research. J Health Care Poor Underserved. 2006;17(4):698-715.
5. US Department of Health and Human Services. Information on protection of human subjects in research funded or regulated by U.S. government. https://www.hhs.gov/1946inoculationstudy/protection.html. Accessed April 24, 2013.
It is becoming more common for clinical trials to be conducted outside of the United States and for the subsequently approved medications to be used in the United States.
As a practicing physician in the United States, I believe medical care in this country is superior to anywhere else in the world. Of course, if you look at statistics such as infant death rates at birth, we continuously rank lower than some countries in Western Europe. But, on the other hand, if we were to just compare ourselves to our northern neighbor, Canada, and consider how long prostate cancer and breast cancer patients have to wait for their surgeries or imaging studies in that country, we are still providing our patients with excellent care.
Moreover, we have always been proud of our research and development (R&D) efforts in this country, and we still have the most advanced R&D programs in the world. Having been involved with clinical research day to day for more than 10 years, I certainly enjoyed the privileges of practicing with the most advanced treatments in dermatology, such as biologics, oncology treatments, even lasers and other medical devices.
Trials Conducted Outside the United States
I recently noticed that outsourcing clinical research to mostly Eastern European countries is happening, where the regulations are much looser and there is a lack of oversight. According to the Inspector General’s report, 80% of the applications submitted to the FDA for a new drug application in 2008 had been from trials in foreign countries. We are witnessing more and more clinical trial data from overseas.1
The best example of this in dermatology is calcipotriene 0.005% betamethasone dipropionate 0.064% (Taclonex). This ointment is approved by the FDA for use in the US, with 100% of the data that led to its approval coming from foreign countries.2 We all know it is cheaper to run studies where the local population lives under difficult conditions. It is easy to recruit patients in poor countries compared to the US.
Regulations are easier to handle, not heavily enforced and certainly beyond the reach of FDA monitoring outside of the United States. The FDA visited only 45 of the 6,485 locations where foreign drug studies were being conducted.1
Dangers Associated with A Lack of Oversight
Finally, malpractice and litigation concerns are not as much of an issue when conducting clinical trials outside of the United States. The potential exploitation of research subjects is a reminder of what happened in this country during the infamous Tuskegee syphilis experiment, where subjects were neither told they had syphilis nor were they ever treated for it.3 This led to the 1979 Belmont report and the establishment of the Office for Human Research Protections.4,5 In 2007, in a similar occurrence, homeless subjects were given money to take part in a flu vaccine experiment in Poland. While they thought they were getting a regular flu shot, they were not, and 20 of the participants died.
The clinical development program has been the basis of the excellent medical care we provide in this country. Unfortunately, it is difficult for me not to think about how Taclonex ointment was developed each time I prescribe it. I am afraid this impetus of shifting clinical trials overseas may lead to us losing the foundation of our superior medicine.
Dr. Kircik is an Associate Clinical Professor of Dermatology at Indiana University Medical Center. His is also the Medical Director of Derm Research, PLLC, and Physicians Skin Care, PLLC, in Louisville, KY.
Disclosure: Dr. Kircik has no conflicts of interest to report in relation to the content of this column.
References
1. Bartlett DL, Steele JB. Deadly medicine. Vanity Fair. January 2011.
2. Kragballe K, van de Kerkhof PC. Consistency of data in six phase III clinical studies of a two-compound product containing calcipitriol and betamethasone dipropionate ointment for the treatment of psoriasis. J Eur Acad Dermatol Venereol. 2006;20(1):39-44.
3. Centers for Disease Control and Prevention. The Tuskegee timeline. https://www.cdc.gov/tuskegee/timeline.htm. Accessed April 24, 2013.
4. Katz RV, Kegeles SS, Kressin NR, et al. The Tuskegee legacy project: Willingness of minorities to participate in biomedical research. J Health Care Poor Underserved. 2006;17(4):698-715.
5. US Department of Health and Human Services. Information on protection of human subjects in research funded or regulated by U.S. government. https://www.hhs.gov/1946inoculationstudy/protection.html. Accessed April 24, 2013.
It is becoming more common for clinical trials to be conducted outside of the United States and for the subsequently approved medications to be used in the United States.
As a practicing physician in the United States, I believe medical care in this country is superior to anywhere else in the world. Of course, if you look at statistics such as infant death rates at birth, we continuously rank lower than some countries in Western Europe. But, on the other hand, if we were to just compare ourselves to our northern neighbor, Canada, and consider how long prostate cancer and breast cancer patients have to wait for their surgeries or imaging studies in that country, we are still providing our patients with excellent care.
Moreover, we have always been proud of our research and development (R&D) efforts in this country, and we still have the most advanced R&D programs in the world. Having been involved with clinical research day to day for more than 10 years, I certainly enjoyed the privileges of practicing with the most advanced treatments in dermatology, such as biologics, oncology treatments, even lasers and other medical devices.
Trials Conducted Outside the United States
I recently noticed that outsourcing clinical research to mostly Eastern European countries is happening, where the regulations are much looser and there is a lack of oversight. According to the Inspector General’s report, 80% of the applications submitted to the FDA for a new drug application in 2008 had been from trials in foreign countries. We are witnessing more and more clinical trial data from overseas.1
The best example of this in dermatology is calcipotriene 0.005% betamethasone dipropionate 0.064% (Taclonex). This ointment is approved by the FDA for use in the US, with 100% of the data that led to its approval coming from foreign countries.2 We all know it is cheaper to run studies where the local population lives under difficult conditions. It is easy to recruit patients in poor countries compared to the US.
Regulations are easier to handle, not heavily enforced and certainly beyond the reach of FDA monitoring outside of the United States. The FDA visited only 45 of the 6,485 locations where foreign drug studies were being conducted.1
Dangers Associated with A Lack of Oversight
Finally, malpractice and litigation concerns are not as much of an issue when conducting clinical trials outside of the United States. The potential exploitation of research subjects is a reminder of what happened in this country during the infamous Tuskegee syphilis experiment, where subjects were neither told they had syphilis nor were they ever treated for it.3 This led to the 1979 Belmont report and the establishment of the Office for Human Research Protections.4,5 In 2007, in a similar occurrence, homeless subjects were given money to take part in a flu vaccine experiment in Poland. While they thought they were getting a regular flu shot, they were not, and 20 of the participants died.
The clinical development program has been the basis of the excellent medical care we provide in this country. Unfortunately, it is difficult for me not to think about how Taclonex ointment was developed each time I prescribe it. I am afraid this impetus of shifting clinical trials overseas may lead to us losing the foundation of our superior medicine.
Dr. Kircik is an Associate Clinical Professor of Dermatology at Indiana University Medical Center. His is also the Medical Director of Derm Research, PLLC, and Physicians Skin Care, PLLC, in Louisville, KY.
Disclosure: Dr. Kircik has no conflicts of interest to report in relation to the content of this column.
References
1. Bartlett DL, Steele JB. Deadly medicine. Vanity Fair. January 2011.
2. Kragballe K, van de Kerkhof PC. Consistency of data in six phase III clinical studies of a two-compound product containing calcipitriol and betamethasone dipropionate ointment for the treatment of psoriasis. J Eur Acad Dermatol Venereol. 2006;20(1):39-44.
3. Centers for Disease Control and Prevention. The Tuskegee timeline. https://www.cdc.gov/tuskegee/timeline.htm. Accessed April 24, 2013.
4. Katz RV, Kegeles SS, Kressin NR, et al. The Tuskegee legacy project: Willingness of minorities to participate in biomedical research. J Health Care Poor Underserved. 2006;17(4):698-715.
5. US Department of Health and Human Services. Information on protection of human subjects in research funded or regulated by U.S. government. https://www.hhs.gov/1946inoculationstudy/protection.html. Accessed April 24, 2013.
