Concern over findings
Analysis Indicates the Findings in Most Modern Medical Studies are Probably False
Date Published: August 31, 2005
Source: Newsinferno.com News Staff
According to an analysis published in the medical journal PLoS Medicine (Public Library of Science), the concern is growing, that in modern research, findings made in many (or even the majority of) scientific studies may be false.
Researcher John Ioannidis of the University of Ioannina School of Medicine, Greece, and Tufts University School of Medicine, identified a number of reasons for these potentially erroneous, or misleading findings.
One reason is that many of the studies conducted are quite small and therefore less likely to be accurate. In addition, in many scientific fields, the "effect sizes" or the measure of how much an external factor (such as smoking) impacts the development or treatment of a disease are simply too small to amount to a significant difference.
Results are more reliable in scientific fields with large effects for example the implication of smoking on cancer. In fields where the effects are small, such as genetic risk factors for diseases which could be caused by many different genes, results are considerably less reliable.
Finally, biases including financial interests and other prejudices of the researchers can skew results. This, Ioannidis suggests, explains why popular fields of scientist in which there is a lot of research activity often begin produce disappointing results after a flurry of interest.
The editors of PLoS , an open access, freely available international medical journal which publishes original research on human health as well as an analysis of important global health issues, evaluated Ioannidis’ article.
Their editorial argued that many scientific findings are not intended to be conclusive but to stimulate further research. However, the editorialists did "encourage authors to discuss biases, study limitations, and potential confounding factors."
The article can be accessed at http://www.plosmedicine.org. For more information on The Public Library of Science a non-profit organization of scientists and physicians who want to make scientific information accessible to the public visit http://www.plos.org.
A related problem which the research staff at newsinferno.com has found to be quite prevalent is that of the regularity and ease with which scientific research is tampered with, falsified, and manipulated. Pharmaceutical companies have also engaged in highly questionable practices in order to influence the creation of and conclusions reached in reports and studies involving their own (or even competitor’s) products. This is by far one of the most disconcerting and frightening practices occurring in the medical profession.
Chester Douglass, a professor at the Harvard School of Dental Medicine was accused of covering up data that suggested a link between fluoridated tap water and osteosarcoma, a rare form of bone cancer, in adolescent boys. He is currently being investigated for claiming that there is no correlation between fluoride and osteosarcoma when previous research and data suggests otherwise.
In fact, his own doctoral student came forward with data from Douglass’s study which concluded that: “Among males, exposure to fluoride at or above the target level was associated with an increased risk of developing osteosarcoma. The association was most apparent between ages 5-10 with a peak at six to eight years of age.”
Douglass’ attempt to falsify and cover-up his data is an incredible breach of the public trust. In addition, Douglass was editing a newsletter funded by Colgate-Palmolive Co. which creates a serious conflict of interest since Colgate-Palmolive manufactures toothpaste with fluoride.
In 1996, Dr. Andrew Friedman was caught faking data in some of his studies that had been published in medical journals. Investigators found that he had been making up information relating to hormonal treatment for gynecological conditions and this information had passed through peer reviews to become published data. He agreed to be excluded from working on federally funded research for three years.
This past year, Eric Poehlman, a professor at the University Of Vermont College Of Medicine, was charged with falsifying research data on issues like menopause, aging, and hormone supplements in order to receive millions of dollars in grant money from the federal government.
In November 2004, Dr. Ali Sultan was discovered to have plagiarized tests and data in his malaria study but substituting results from one type of malaria for another. When charged, he placed all the blame on a postdoctoral student. He later resigned and became a faculty member at the Cornell Medical College in Qatar.
Anne Butkovitz, a coordinator at a pediatric practice involved in an FDA approved clinical study, has been charged with falsifying data with respect to follow up contact information she was supposed to obtain directly from the parents of children vaccinated with an experimental rotavirus vaccine. Rotavirus causes severe diarrhea in infants. The purpose of the follow-ups was to determine if there had been any serious adverse experiences (SAEs).
It is alleged that Ms. Butkovitz did not make the required contacts and yet claimed that she had on report forms. In one case, she is accused of having actually falsified information with respect to the SAEs of a patient enrolled in the clinical study. As a result of Ms. Butkovitz’s actions, the pharmaceutical company involved removed the pediatric practice she was employed by from the study and disregarded the data it had generated.
A survey involving 3,247 scientists who were based in the United States and who had received funding from the National Institutes of Health revealed that about 33% of the participants stated that, within the previous three years, they had engaged in at least one practice that could get them into trouble.
The types of questionable conduct included circumventing minor aspect of rules for doing research on people (8%) and ignoring another researcher’s use of flawed data or questionable interpretation of data (about 13%). Less than 2% admitted falsifying data, plagiarism, or ignoring major aspects of rules governing studies with human subjects. Surprisingly (or maybe not so surprisingly), almost 16% admitted they had changed the designs, methods, or results of a study “in response to pressure from a funding source.”
The National Institutes of Health (NIH) is conducting an internal review with respect to consulting payments from pharmaceutical companies to scientists employed by the agency. Of the sample, more than half (44 of 81) admitted to conduct which violated one or more NIH rules. Of those, 36 are still employed by the agency and were referred for possible disciplinary action. Nine of those 36 have also been referred to the HHS Office of Inspector general for further investigation. The 8 who left the agency are not subject to administrative action.
The House Energy and Commerce Committee requested the review after comparing NIH records to consulting agreements maintained by 20 pharmaceutical companies. The Committee found 81 cases between 1999 and 2004 where the agreements were not listed in the NIH records provided to the committee.
Excerpts from the findings of the investigation, provided by NIH Director Elias A. Zerhouni to three members of Congress included the following statement: "We discovered cases of employees who consulted with research entities without seeking required approval, consulted in areas that appeared to conflict with their official duties, or consulted in situations where the main benefit was the ability of the employer to invoke the name of NIH as an affiliation.” Although Zerhouni requested the release to Congress to be treated as confidential, Committee leaders released it as a matter of compelling public interest.
Clearly, if the results of the analysis done by John Ioannidis are accurate and the above examples of unethical, dangerous, and criminal conduct are also considered, there is reason for there to be concern on the part of the public, governmental agencies, and medical professionals when it comes to being able to trust information which should be scientifically accurate as well as above reproach.
Date Published: August 31, 2005
Source: Newsinferno.com News Staff
According to an analysis published in the medical journal PLoS Medicine (Public Library of Science), the concern is growing, that in modern research, findings made in many (or even the majority of) scientific studies may be false.
Researcher John Ioannidis of the University of Ioannina School of Medicine, Greece, and Tufts University School of Medicine, identified a number of reasons for these potentially erroneous, or misleading findings.
One reason is that many of the studies conducted are quite small and therefore less likely to be accurate. In addition, in many scientific fields, the "effect sizes" or the measure of how much an external factor (such as smoking) impacts the development or treatment of a disease are simply too small to amount to a significant difference.
Results are more reliable in scientific fields with large effects for example the implication of smoking on cancer. In fields where the effects are small, such as genetic risk factors for diseases which could be caused by many different genes, results are considerably less reliable.
Finally, biases including financial interests and other prejudices of the researchers can skew results. This, Ioannidis suggests, explains why popular fields of scientist in which there is a lot of research activity often begin produce disappointing results after a flurry of interest.
The editors of PLoS , an open access, freely available international medical journal which publishes original research on human health as well as an analysis of important global health issues, evaluated Ioannidis’ article.
Their editorial argued that many scientific findings are not intended to be conclusive but to stimulate further research. However, the editorialists did "encourage authors to discuss biases, study limitations, and potential confounding factors."
The article can be accessed at http://www.plosmedicine.org. For more information on The Public Library of Science a non-profit organization of scientists and physicians who want to make scientific information accessible to the public visit http://www.plos.org.
A related problem which the research staff at newsinferno.com has found to be quite prevalent is that of the regularity and ease with which scientific research is tampered with, falsified, and manipulated. Pharmaceutical companies have also engaged in highly questionable practices in order to influence the creation of and conclusions reached in reports and studies involving their own (or even competitor’s) products. This is by far one of the most disconcerting and frightening practices occurring in the medical profession.
Chester Douglass, a professor at the Harvard School of Dental Medicine was accused of covering up data that suggested a link between fluoridated tap water and osteosarcoma, a rare form of bone cancer, in adolescent boys. He is currently being investigated for claiming that there is no correlation between fluoride and osteosarcoma when previous research and data suggests otherwise.
In fact, his own doctoral student came forward with data from Douglass’s study which concluded that: “Among males, exposure to fluoride at or above the target level was associated with an increased risk of developing osteosarcoma. The association was most apparent between ages 5-10 with a peak at six to eight years of age.”
Douglass’ attempt to falsify and cover-up his data is an incredible breach of the public trust. In addition, Douglass was editing a newsletter funded by Colgate-Palmolive Co. which creates a serious conflict of interest since Colgate-Palmolive manufactures toothpaste with fluoride.
In 1996, Dr. Andrew Friedman was caught faking data in some of his studies that had been published in medical journals. Investigators found that he had been making up information relating to hormonal treatment for gynecological conditions and this information had passed through peer reviews to become published data. He agreed to be excluded from working on federally funded research for three years.
This past year, Eric Poehlman, a professor at the University Of Vermont College Of Medicine, was charged with falsifying research data on issues like menopause, aging, and hormone supplements in order to receive millions of dollars in grant money from the federal government.
In November 2004, Dr. Ali Sultan was discovered to have plagiarized tests and data in his malaria study but substituting results from one type of malaria for another. When charged, he placed all the blame on a postdoctoral student. He later resigned and became a faculty member at the Cornell Medical College in Qatar.
Anne Butkovitz, a coordinator at a pediatric practice involved in an FDA approved clinical study, has been charged with falsifying data with respect to follow up contact information she was supposed to obtain directly from the parents of children vaccinated with an experimental rotavirus vaccine. Rotavirus causes severe diarrhea in infants. The purpose of the follow-ups was to determine if there had been any serious adverse experiences (SAEs).
It is alleged that Ms. Butkovitz did not make the required contacts and yet claimed that she had on report forms. In one case, she is accused of having actually falsified information with respect to the SAEs of a patient enrolled in the clinical study. As a result of Ms. Butkovitz’s actions, the pharmaceutical company involved removed the pediatric practice she was employed by from the study and disregarded the data it had generated.
A survey involving 3,247 scientists who were based in the United States and who had received funding from the National Institutes of Health revealed that about 33% of the participants stated that, within the previous three years, they had engaged in at least one practice that could get them into trouble.
The types of questionable conduct included circumventing minor aspect of rules for doing research on people (8%) and ignoring another researcher’s use of flawed data or questionable interpretation of data (about 13%). Less than 2% admitted falsifying data, plagiarism, or ignoring major aspects of rules governing studies with human subjects. Surprisingly (or maybe not so surprisingly), almost 16% admitted they had changed the designs, methods, or results of a study “in response to pressure from a funding source.”
The National Institutes of Health (NIH) is conducting an internal review with respect to consulting payments from pharmaceutical companies to scientists employed by the agency. Of the sample, more than half (44 of 81) admitted to conduct which violated one or more NIH rules. Of those, 36 are still employed by the agency and were referred for possible disciplinary action. Nine of those 36 have also been referred to the HHS Office of Inspector general for further investigation. The 8 who left the agency are not subject to administrative action.
The House Energy and Commerce Committee requested the review after comparing NIH records to consulting agreements maintained by 20 pharmaceutical companies. The Committee found 81 cases between 1999 and 2004 where the agreements were not listed in the NIH records provided to the committee.
Excerpts from the findings of the investigation, provided by NIH Director Elias A. Zerhouni to three members of Congress included the following statement: "We discovered cases of employees who consulted with research entities without seeking required approval, consulted in areas that appeared to conflict with their official duties, or consulted in situations where the main benefit was the ability of the employer to invoke the name of NIH as an affiliation.” Although Zerhouni requested the release to Congress to be treated as confidential, Committee leaders released it as a matter of compelling public interest.
Clearly, if the results of the analysis done by John Ioannidis are accurate and the above examples of unethical, dangerous, and criminal conduct are also considered, there is reason for there to be concern on the part of the public, governmental agencies, and medical professionals when it comes to being able to trust information which should be scientifically accurate as well as above reproach.
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