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Results Of Many Clinical Trials Not Being Reported
http://www.npr.org/blogs/health/2015/03/11/392355433/results-of-many-clinical-trials-not-being-reported
"Many scientists are failing to live up to a 2007 law that requires them to report the results of their clinical trials to a public website, according to a study in Thursday's New England Journal of Medicine.
The website is clinicaltrials.gov, which draws 57,000 visitors a day, including people who are confronting serious diseases and looking for experimental treatments. A study from Duke University finds that five years after the reporting law took effect, only 13 percent of scientists running clinical trials had reported their results.
"We were really surprised to find that very few people are following the law," says Dr. Monique Anderson, a cardiologist and the study's first author.
There are many exceptions in the law, so many of those who have not reported results are at least temporarily exempt from doing so. But Dr. Anderson says researchers should also feel an ethical obligation to make data generated by human volunteers available promptly.
"Any patient who participates in clinical research should expect to see that their participation is going to be used effectively," she says.
People desperate for cures and treatments who are searching these results are also being shortchanged.
Larry Lightner found himself on clinicaltrials.gov after his then 9-year-old son, Glenn, developed a rare brain cancer in 2009.
Lightner, from Long Valley, N.J., says Glenn's initial radiation treatment worked for a while, but the treatment itself had a serious side effect. Glenn "developed a second cancer, which was far more aggressive than the first cancer. One of the oncologists at NYU suggested that we look into clinical trials, because they knew they had nothing to cure this cancer with."
Night After Night, Year After Year, 'No Results Posted'
Lightner is a transportation manager, not a scientist, but he spent four hours a night, every night, on clinicaltrials.gov, looking for something that could help Glenn.
"Every time I clicked on the results tab, it always said 'no results posted,' night after night, year after year."
That's only a mild overstatement, considering that the 13 percent reporting figure from the Duke study excludes many studies that don't fall under the reporting law. There's a complicated list of exemptions, and it's impossible to tell by looking at a study on clinicaltrials.gov whether the scientists have neglected to report their results or simply don't have to.
Anderson's study found that experiments sponsored by the pharmaceutical industry had a much better track record than university experiments funded by the National Institutes of Health or other agencies.
About half of the missing reports from industry-sponsored research were temporarily exempt. Companies are allowed to sit on their data at times to preserve a competitive advantage if they're trying to develop a new drug.
That is not the case for studies funded by the NIH or other agencies, "who are just lagging," Anderson says.
Even counting the late entries and allowable exceptions, only about 50 percent of taxpayer-funded research has been reported back to the taxpayers on clinicaltrials.gov, she says.
The study doesn't assess why universities are frequently failing to post their results. As it happens, Duke University is considered a good example of what a university needs to do to comply with the law.
"It was extremely difficult," says Dr. Mike Stacy, a neurologist and vice dean for clinical research at Duke. He says the university had a team working for months to develop a compliance system, and Duke has kept two full-time staffers to parse the complicated rules — and to remind and cajole Duke scientists to fill out the forms.
"These are very busy people and this represents a new step in workflow, and we don't always do well when we add a step in workflow," Stacy says.
Some Scientists Avoid Publishing Bad News
But one worry is that the scientists who aren't complying aren't simply busy. Dr. Mark Helfand, a professor of medicine at Oregon Health and Science University says scientists are generally more likely to publish good news and ignore bad news, which skews the scientific record. He's concerned that may be occurring on clinicaltrials.gov as well.
What's more, Dr. Helfand has found that what's published in medical journals doesn't necessarily match what was reported in clinicaltrials.gov.
"In a significant proportion of cases, the results on cliniclaltrials.gov were reported more thoroughly than the results in corresponding journal articles," he says.
Serious side-effects in particular were more likely to be reported online than in a published study.
Universities who don't report their studies on time can face fines of $10,000 a day. Scientists can even lose NIH research grants. But even though the law was passed in 2007, the government is still trying to finalize the precise rules. And in the meantime, no transgressors are being punished.
Larry Lightner, whose son had brain cancer, is rallying patient-advocates to support disclosure rules with no exceptions. He has put out the call both from his popular Facebook page and his website, FixCancerNow.
"There are a lot of parents who have asked for the results of a clinical trial that their child was in, and they will not get an answer," he says. The scientists "refuse to give them the results."
And as for Glenn: He died December 12, 2012. He was 14."
"Many scientists are failing to live up to a 2007 law that requires them to report the results of their clinical trials to a public website, according to a study in Thursday's New England Journal of Medicine.
The website is clinicaltrials.gov, which draws 57,000 visitors a day, including people who are confronting serious diseases and looking for experimental treatments. A study from Duke University finds that five years after the reporting law took effect, only 13 percent of scientists running clinical trials had reported their results.
"We were really surprised to find that very few people are following the law," says Dr. Monique Anderson, a cardiologist and the study's first author.
There are many exceptions in the law, so many of those who have not reported results are at least temporarily exempt from doing so. But Dr. Anderson says researchers should also feel an ethical obligation to make data generated by human volunteers available promptly.
"Any patient who participates in clinical research should expect to see that their participation is going to be used effectively," she says.
People desperate for cures and treatments who are searching these results are also being shortchanged.
Larry Lightner found himself on clinicaltrials.gov after his then 9-year-old son, Glenn, developed a rare brain cancer in 2009.
Lightner, from Long Valley, N.J., says Glenn's initial radiation treatment worked for a while, but the treatment itself had a serious side effect. Glenn "developed a second cancer, which was far more aggressive than the first cancer. One of the oncologists at NYU suggested that we look into clinical trials, because they knew they had nothing to cure this cancer with."
Night After Night, Year After Year, 'No Results Posted'
Lightner is a transportation manager, not a scientist, but he spent four hours a night, every night, on clinicaltrials.gov, looking for something that could help Glenn.
"Every time I clicked on the results tab, it always said 'no results posted,' night after night, year after year."
That's only a mild overstatement, considering that the 13 percent reporting figure from the Duke study excludes many studies that don't fall under the reporting law. There's a complicated list of exemptions, and it's impossible to tell by looking at a study on clinicaltrials.gov whether the scientists have neglected to report their results or simply don't have to.
Anderson's study found that experiments sponsored by the pharmaceutical industry had a much better track record than university experiments funded by the National Institutes of Health or other agencies.
About half of the missing reports from industry-sponsored research were temporarily exempt. Companies are allowed to sit on their data at times to preserve a competitive advantage if they're trying to develop a new drug.
That is not the case for studies funded by the NIH or other agencies, "who are just lagging," Anderson says.
Even counting the late entries and allowable exceptions, only about 50 percent of taxpayer-funded research has been reported back to the taxpayers on clinicaltrials.gov, she says.
The study doesn't assess why universities are frequently failing to post their results. As it happens, Duke University is considered a good example of what a university needs to do to comply with the law.
"It was extremely difficult," says Dr. Mike Stacy, a neurologist and vice dean for clinical research at Duke. He says the university had a team working for months to develop a compliance system, and Duke has kept two full-time staffers to parse the complicated rules — and to remind and cajole Duke scientists to fill out the forms.
"These are very busy people and this represents a new step in workflow, and we don't always do well when we add a step in workflow," Stacy says.
Some Scientists Avoid Publishing Bad News
But one worry is that the scientists who aren't complying aren't simply busy. Dr. Mark Helfand, a professor of medicine at Oregon Health and Science University says scientists are generally more likely to publish good news and ignore bad news, which skews the scientific record. He's concerned that may be occurring on clinicaltrials.gov as well.
What's more, Dr. Helfand has found that what's published in medical journals doesn't necessarily match what was reported in clinicaltrials.gov.
"In a significant proportion of cases, the results on cliniclaltrials.gov were reported more thoroughly than the results in corresponding journal articles," he says.
Serious side-effects in particular were more likely to be reported online than in a published study.
Universities who don't report their studies on time can face fines of $10,000 a day. Scientists can even lose NIH research grants. But even though the law was passed in 2007, the government is still trying to finalize the precise rules. And in the meantime, no transgressors are being punished.
Larry Lightner, whose son had brain cancer, is rallying patient-advocates to support disclosure rules with no exceptions. He has put out the call both from his popular Facebook page and his website, FixCancerNow.
"There are a lot of parents who have asked for the results of a clinical trial that their child was in, and they will not get an answer," he says. The scientists "refuse to give them the results."
And as for Glenn: He died December 12, 2012. He was 14."
That's interesting, I never could find results of Roche trial I was on. Other than finding it was stopped, two people died, lowered WBC too low.
I heard that auditors had to stop the trial.
Thank you
Dee
I heard that auditors had to stop the trial.
Thank you
Dee
Genetic Test Maker 23andMe Launches Drug R&D Effort
http://abcnews.go.com/Technology/wireStory/genetic-test-maker-23andme-launches-drug-effort-29577501
"Google-backed genetic testing company 23andMe is launching its own drug development unit, betting that it can translate its database of customer DNA information into novel medicines.
The Silicon Valley-based company announced Thursday that it hired Richard Scheller, a former Genentech executive, to become its chief scientist and lead the company's research and development efforts. Scheller recently retired from a 14-year career with South San Francisco, California-based Genentech, a pioneer of biotech cancer drugs.
23andMe is best known for its saliva-based test kits, which offer users the chance to peek into their genetic code for clues about their ancestral past. But drug research has always been at the foundation of its business model. Much the way social media websites sell advertisers access to their user networks, 23andMe licenses the raw data from its DNA database to researchers. The company has more than 20 partnerships with drug companies including Pfizer and Roche, as well as with government and academic researchers.
But now 23andMe plans to pursue its own drug R&D efforts. CEO Anne Wojcicki said the company's genetic insights could help streamline the time-consuming drug discovery process.
"Drug development has only become more expensive over the last 20 years," Wojcicki said in an interview with The Associated Press. "I think there is the potential that we could develop a faster, better approach to drug development."
It can take more than a decade and over $1 billion to bring a new drug to market, according to some industry estimates. That figure includes the cost of the many drug failures that never make it to the market.
Scheller says the drug industry could improve its track record by targeting research efforts toward patients with specific genetic markers.
"We can bring down the cost if we can have fewer failures," Scheller said in an interview. "This database that 23andMe has accumulated is by far the largest human genetic database in the world and it's a terrific resource."
More than 850,000 people have used 23andMe's test kit, a small plastic tube that customers fill with spit and return to the company for genetic processing. They receive a report analyzing their genetic code for clues about their ancestry and family history. About 680,000 of those customers have given 23andMe permission to use their data for research, including drug development.
Wojcicki says the company's new R&D efforts do not change its research consent policy.
"The business we have is built on a relationship with the consumer and that remains the core of the company," Wojcicki said.
Outside observers say it could still take significant time and money to translate 23andMe's genetic information into effective treatments.
"It's a tremendous amount of work to take a genetic finding and move it into a drug that will target that pathway," said Dr. Robert Green, a geneticist at Harvard Medical School and Brigham and Women's Hospital. Green has received federal funding to study genetic testing practices, including those of 23andMe, though he has no financial relationship with the company.
While starting up its own pharmaceutical unit would seem to put 23andMe into competition with the drugmakers that use its database, Wojcicki says those companies have been supportive. Rather than launching competing products, Wojcicki expects 23andMe to license many of its drug discoveries to larger, more established drugmakers."
http://abcnews.go.com/Technology/wireStory/genetic-test-maker-23andme-launches-drug-effort-29577501
"Google-backed genetic testing company 23andMe is launching its own drug development unit, betting that it can translate its database of customer DNA information into novel medicines.
The Silicon Valley-based company announced Thursday that it hired Richard Scheller, a former Genentech executive, to become its chief scientist and lead the company's research and development efforts. Scheller recently retired from a 14-year career with South San Francisco, California-based Genentech, a pioneer of biotech cancer drugs.
23andMe is best known for its saliva-based test kits, which offer users the chance to peek into their genetic code for clues about their ancestral past. But drug research has always been at the foundation of its business model. Much the way social media websites sell advertisers access to their user networks, 23andMe licenses the raw data from its DNA database to researchers. The company has more than 20 partnerships with drug companies including Pfizer and Roche, as well as with government and academic researchers.
But now 23andMe plans to pursue its own drug R&D efforts. CEO Anne Wojcicki said the company's genetic insights could help streamline the time-consuming drug discovery process.
"Drug development has only become more expensive over the last 20 years," Wojcicki said in an interview with The Associated Press. "I think there is the potential that we could develop a faster, better approach to drug development."
It can take more than a decade and over $1 billion to bring a new drug to market, according to some industry estimates. That figure includes the cost of the many drug failures that never make it to the market.
Scheller says the drug industry could improve its track record by targeting research efforts toward patients with specific genetic markers.
"We can bring down the cost if we can have fewer failures," Scheller said in an interview. "This database that 23andMe has accumulated is by far the largest human genetic database in the world and it's a terrific resource."
More than 850,000 people have used 23andMe's test kit, a small plastic tube that customers fill with spit and return to the company for genetic processing. They receive a report analyzing their genetic code for clues about their ancestry and family history. About 680,000 of those customers have given 23andMe permission to use their data for research, including drug development.
Wojcicki says the company's new R&D efforts do not change its research consent policy.
"The business we have is built on a relationship with the consumer and that remains the core of the company," Wojcicki said.
Outside observers say it could still take significant time and money to translate 23andMe's genetic information into effective treatments.
"It's a tremendous amount of work to take a genetic finding and move it into a drug that will target that pathway," said Dr. Robert Green, a geneticist at Harvard Medical School and Brigham and Women's Hospital. Green has received federal funding to study genetic testing practices, including those of 23andMe, though he has no financial relationship with the company.
While starting up its own pharmaceutical unit would seem to put 23andMe into competition with the drugmakers that use its database, Wojcicki says those companies have been supportive. Rather than launching competing products, Wojcicki expects 23andMe to license many of its drug discoveries to larger, more established drugmakers."
"Anderson's study found that experiments sponsored by the pharmaceutical industry had a much better track record than university experiments funded by the National Institutes of Health or other agencies"
That is the answer : for example If a cure for cancer were found, the pharmas would no longer be reaping billions from selling meds for cancer treatment.
That is the answer : for example If a cure for cancer were found, the pharmas would no longer be reaping billions from selling meds for cancer treatment.
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