I never get tired of hearing about Doug's success.
By Anthony Brino, BDN Staff
Posted April 23, 2016
https://bangordailynews.com/2016/04/23/news/aroostook/after-regaining-sight-presque-isle-native-touts-stem-cell-treatments/
Doug Oliver says that he knows what it’s like to go blind and see again, and he wants others to have the same chance.
“I’m seeing very well and am likely to enjoy this vision for the remainder of my lifetime,” said Oliver, a 1980 Presque Isle High School graduate who was diagnosed with a rare form of blindness 11 years ago.
The degenerative disease, malattia leventinese, affects some 10,000 Americans, and it upended and reshaped Oliver’s life. He was working as a social services director in New Hampshire when, after almost driving into four pedestrians in two different crosswalks one day, he realized he was having trouble seeing. In 2008, he said he stopped driving after being diagnosed as legally blind, which in the U.S. constitutes a visual acuity of 20/200 or worse.
He said he gave up his job, and went from earning $90,000 to less than $30,000, working part-time at Walgreens and qualifying for Social Security Disability Income. In 2010, he moved to Nashville, Tennessee, for its warmer climate, its public transit and an open position at a Walgreens, and he soon met his second wife, Ann, who also would be his guide.
With measured vision of 20/400 in his better eye, he said he could walk, sometimes needing a cane, and read in short bursts using heavy magnification. “I had no depth perception, and couldn’t tell what the terrain was like underneath my feet.”
At the advice of a doctor at the Vanderbilt Eye Institute, Oliver started to search for clinical trials, and in February 2015, he learned of the Stem Cell Ophthalmology Treatment Study, a privately funded trial registered with the National Institutes of Health evaluating the use of bone marrow-derived stem cells in people with lost vision from retinal or optic nerve conditions.
By August of last year, he had raised more than $21,000 and traveled to Retina Associates of South Florida in Margate, where the doctors running the trial are based. The procedure took stem cells — precursor cells that can develop into other cells and organs — from his bone marrow and injected them into his eyes, with the aim of helping regrow healthy retinal cells. Gradually, in the two months after the operation, Oliver said his sight returned, and in December he got his driver’s license back — with his measured vision at 20/30 and 20/40.
“I have found that it’s almost as much an emotional adjustment to be regaining sight as to be losing it. My wife has never known me as a sighted person,” Oliver said.
“The most important thing to me is being able to see faces. I saw my grandchildren’s faces in South Portland. I can count the leaves on trees. I went to a grocery store after surgery when it was kicking in, and just looked at the prices. I walked around the aisles just looking at the price tags.”
Oliver said he emerged from the surgery with his sight as well as a vision for the benefits of adult stem cell treatments, which in the U.S. are offered selectively through research trials as well as through private clinics that are not covered by insurance or even fully regulated.
The Food and Drug Administration has not approved any stem cell-based treatments, only therapies using umbilical cord-derived stem cells in treatment of blood cancers and genetic metabolic and immune disorders. Adult stem cells from a patient or a donor are used through bone marrow transplants in treating certain cancers and are considered surgical procedures — as are the outpatient stem cell treatments being promoted for a range of ailments without the support of long-term studies or FDA approval.
Recently the FDA has warned consumers about unapproved stem cell treatments and also has considered the possibility of declaring oversight of the procedures as biological products.
Although Oliver admits there are some for-profit clinics selling stem cell treatments that aren’t supported by research, he and other patient advocates are worried that if the FDA regulates stem cells as drugs, it will curtail their access.
He’s now trying to rally support for the REGROW Act, legislation that would create a new pathway for the FDA to approve regenerative medical treatments like stem cells. Coincidently co-sponsored by U.S. Sen. Susan Collins, it would streamline the approval process and offer the opportunity for insurance coverage. While there is still a lot of skepticism about stem cells, Oliver said he believes stem cells should have their own regulatory category that is flexible enough to offer patients access to treatments that remain quasi-experimental.
“The idea that cellular therapy can be regulated as drugs is not seen as possible because it’s totally unique.”
A lot of research examining the use of stem cells to treat everything from blindness to multiple sclerosis to stroke damage is still in the early and middle stages, being done by private outfits as well as university-affiliated scientists. The trial Oliver participated in will likely conclude by the end of 2017, after treating about 300 patients, and so far the outcomes are mixed, said Dr. Steven Levy, an opthamologist who’s directing the study.
“We have had very dramatic improvements such as with Mr. Oliver and patients with moderate, small and no improvements,” Levy wrote in an email. “Unfortunately it is not predictable at this time.”
The FDA has for the time being withdrawn its proposal to consider regulations for stem cells, and the REGROW Act is now an amendment tacked onto a larger bill aimed at modernizing the workforce of the FDA and the National Institutes of Health.
Among others, Oliver has successfully lobbied U.S. Sen. Lamar Alexander of Tennessee to support the new approval process, and as he approaches his first full summer of sight in more than a decade, he is considering his future. He’s thinking of returning to social services or starting an organization focusing on stem cell research and access.
Oliver said he’s optimistic about the possibility of stem cell treatments helping people with disabilities re-enter the workforce.
“In stem cell research, it’s not a battle to be won,” Oliver said. “It’s a symphony to be played, and there is a lot still to be discovered.”
By Anthony Brino, BDN Staff
Posted April 23, 2016
https://bangordailynews.com/2016/04/23/news/aroostook/after-regaining-sight-presque-isle-native-touts-stem-cell-treatments/
Doug Oliver says that he knows what it’s like to go blind and see again, and he wants others to have the same chance.
“I’m seeing very well and am likely to enjoy this vision for the remainder of my lifetime,” said Oliver, a 1980 Presque Isle High School graduate who was diagnosed with a rare form of blindness 11 years ago.
The degenerative disease, malattia leventinese, affects some 10,000 Americans, and it upended and reshaped Oliver’s life. He was working as a social services director in New Hampshire when, after almost driving into four pedestrians in two different crosswalks one day, he realized he was having trouble seeing. In 2008, he said he stopped driving after being diagnosed as legally blind, which in the U.S. constitutes a visual acuity of 20/200 or worse.
He said he gave up his job, and went from earning $90,000 to less than $30,000, working part-time at Walgreens and qualifying for Social Security Disability Income. In 2010, he moved to Nashville, Tennessee, for its warmer climate, its public transit and an open position at a Walgreens, and he soon met his second wife, Ann, who also would be his guide.
With measured vision of 20/400 in his better eye, he said he could walk, sometimes needing a cane, and read in short bursts using heavy magnification. “I had no depth perception, and couldn’t tell what the terrain was like underneath my feet.”
At the advice of a doctor at the Vanderbilt Eye Institute, Oliver started to search for clinical trials, and in February 2015, he learned of the Stem Cell Ophthalmology Treatment Study, a privately funded trial registered with the National Institutes of Health evaluating the use of bone marrow-derived stem cells in people with lost vision from retinal or optic nerve conditions.
By August of last year, he had raised more than $21,000 and traveled to Retina Associates of South Florida in Margate, where the doctors running the trial are based. The procedure took stem cells — precursor cells that can develop into other cells and organs — from his bone marrow and injected them into his eyes, with the aim of helping regrow healthy retinal cells. Gradually, in the two months after the operation, Oliver said his sight returned, and in December he got his driver’s license back — with his measured vision at 20/30 and 20/40.
“I have found that it’s almost as much an emotional adjustment to be regaining sight as to be losing it. My wife has never known me as a sighted person,” Oliver said.
“The most important thing to me is being able to see faces. I saw my grandchildren’s faces in South Portland. I can count the leaves on trees. I went to a grocery store after surgery when it was kicking in, and just looked at the prices. I walked around the aisles just looking at the price tags.”
Oliver said he emerged from the surgery with his sight as well as a vision for the benefits of adult stem cell treatments, which in the U.S. are offered selectively through research trials as well as through private clinics that are not covered by insurance or even fully regulated.
The Food and Drug Administration has not approved any stem cell-based treatments, only therapies using umbilical cord-derived stem cells in treatment of blood cancers and genetic metabolic and immune disorders. Adult stem cells from a patient or a donor are used through bone marrow transplants in treating certain cancers and are considered surgical procedures — as are the outpatient stem cell treatments being promoted for a range of ailments without the support of long-term studies or FDA approval.
Recently the FDA has warned consumers about unapproved stem cell treatments and also has considered the possibility of declaring oversight of the procedures as biological products.
Although Oliver admits there are some for-profit clinics selling stem cell treatments that aren’t supported by research, he and other patient advocates are worried that if the FDA regulates stem cells as drugs, it will curtail their access.
He’s now trying to rally support for the REGROW Act, legislation that would create a new pathway for the FDA to approve regenerative medical treatments like stem cells. Coincidently co-sponsored by U.S. Sen. Susan Collins, it would streamline the approval process and offer the opportunity for insurance coverage. While there is still a lot of skepticism about stem cells, Oliver said he believes stem cells should have their own regulatory category that is flexible enough to offer patients access to treatments that remain quasi-experimental.
“The idea that cellular therapy can be regulated as drugs is not seen as possible because it’s totally unique.”
A lot of research examining the use of stem cells to treat everything from blindness to multiple sclerosis to stroke damage is still in the early and middle stages, being done by private outfits as well as university-affiliated scientists. The trial Oliver participated in will likely conclude by the end of 2017, after treating about 300 patients, and so far the outcomes are mixed, said Dr. Steven Levy, an opthamologist who’s directing the study.
“We have had very dramatic improvements such as with Mr. Oliver and patients with moderate, small and no improvements,” Levy wrote in an email. “Unfortunately it is not predictable at this time.”
The FDA has for the time being withdrawn its proposal to consider regulations for stem cells, and the REGROW Act is now an amendment tacked onto a larger bill aimed at modernizing the workforce of the FDA and the National Institutes of Health.
Among others, Oliver has successfully lobbied U.S. Sen. Lamar Alexander of Tennessee to support the new approval process, and as he approaches his first full summer of sight in more than a decade, he is considering his future. He’s thinking of returning to social services or starting an organization focusing on stem cell research and access.
Oliver said he’s optimistic about the possibility of stem cell treatments helping people with disabilities re-enter the workforce.
“In stem cell research, it’s not a battle to be won,” Oliver said. “It’s a symphony to be played, and there is a lot still to be discovered.”