According to Nature, researchers are poised to meet with the FDA this month to discuss “medicines that delay ageing-related disease as legitimate drugs.” This makes sense, given that there are a number of scientific teams working on such compounds. Nir Barzilai of the Albert Einstein College of Medicine in New York is one of those scientists, and the compond he’s focused on is metformin, which has shown promise in previous studies.
From the WSJ:
“A Food and Drug Administration advisory panel has recommended the first drug to help combat female sexual dysfunction. And Sprout Pharmaceuticals, which owns the pill, hopes agency approval will occur in mid-August.”
“It’s well known to health policy types, but less so to consumers, that health care prices are utterly lacking in transparency and wildly variable.
If you’ve ever looked at a bill for a health care procedure — and been astounded by the numbers you see — or thought that you would like to find the best price on an elective procedure – and been astounded that there’s no easy way to compare prices — KQED is launching a new project for you.”
From MIT Tech Review:
“An infant delivered last week in California appears to be the first healthy person ever born in the U.S. with his entire genetic makeup deciphered in advance.
His father, Razib Khan, is a graduate student and professional blogger on genetics who says he worked out a rough draft of his son’s genome early this year in a do-it-yourself fashion after managing to obtain a tissue sample from the placenta.”
I was honored to be on a panel tonight with tissue engineering pioneer Dr. Anthony Atala, Patient advocate Katie Jackson, and science artist Kelly Milukas. It was a fun panel and a great discussion about how to get more community members involved in supporting life-saving advances in regenerative medicine. Our audience, mainly scientists, wowed me after the discussion with stories of their world-changing work.
When I got tested in 2011, I was the first to ask my doctor’s office about genetic results. Exasperated with the transition to electronic medical records, they weren’t eager to deal with yet another change. But the more patients ask, the more doctors are listening. That’s what the Internet has done in countless industries: Force old dogs to learn new tricks. It’s never pretty, but the results have been overwhelmingly positive.
The test has been on the market since 2007, and now the FDA says something? Allowing consumers to get direct access to their own data doesn’t seem like much of a safety issue. If 23andMe’s tests are not as accurate as others, let that be known. Indeed, it is good that the FDA has pointed out that the company has not proven its tech according to FDA standards. BUT, that’s not exactly cause to shut down the service either. Getting to the health revolution that we all know is right around the corner will also require dealing with the old regulatory structures that were set up before the information age. That makes it a bit of a tough road. The FDA needs to be updated for the times. Here’s the 23andMe story.
A similar treatment for humans has been curtailed by the FDA. If you’re a dog, this is fantastic news.
This is the latest in a series of studies to show that aging can be manipulated. If scientists were able to do for humans what these Mayo Clinic researchers did for mice, many more people would be in much better health at older ages. Now, why isn’t everyone who cares about the cost of health care rallying for more work in this area?
What would you do with another 75 years on this Earth? Not as a pain wracked wizened elder in a nursing home, but as a vibrant super-centenarian with the energy of a 30 year old? Sonia Arrison is here to tell you it’s not only possible, it’s coming soon. The author, journalist, futurist and Silicon Valley insider’s latest book, 100+, explores the science and the fallout of extending our lifespans. Easy to read, and easy to understand, 100+ walks you through the incredible achievements in regenerative medicine we’ve already seen, projects them forward, and discusses the changes in environment, economy, family, and religion that will follow.
Here’s the first part of my column on the recent Congressional investigation into the genomcs industry:
The genomics industry, which provides reports about disease risk, ancestry, and drug reactions based on one’s DNA, came under fire last week as a Congressional Committee held hearings and the Government Accountability Office (GAO) released an unscientific “study” of the sector.
According to undercover discussions with genomics firms, the GAO reports that “fictitious consumers received test results that are misleading and of little or no practical use.” The agency admits, however, that it “did not conduct a scientific study but instead documented observations that could be made by any consumer.”
The GAO’s “sting” operation on this nascent field looks more like a witch hunt, given that it lumped in legitimate testing companies with others that are not.
In one instance, a company representative said that it would be OK to send in someone else’s saliva to be tested. As the GAO points out, that practice is already restricted in 33 states, so this seems more like a matter of enforcement.
The GAO’s report is a tricky way of attempting to perturb the public about genetic testing, but it also raises a key question: Why haven’t government regulators disciplined the companies that are clearly breaking the already-established rules?
The GAO also blasts the genomics industry for providing different results for the same DNA, but when dealing with something as complicated as the human body, there often are valid scientific reasons for variation. As 23andMe points out on its blog, testing is not yet standardized, and some companies “employ different statistical models for making risk estimates; they establish different criteria for the inclusion of associations in their reports; and new associations are being discovered at a faster rate than companies’ development cycles.”
Read more here: http://www.technewsworld.com/story/70499.html
It’s been a tough week for the personal genomics testing marketplace. First there were two long days of FDA meetings, and then today an Energy and Commerce Committee held hearings where the GAO announced the results of a “sting” operation into direct to consumer (DTC) genomics companies. Below is the (brutal) GAO video. As Daniel MacArthur has pointed out, today there exist both legitimate and not-so-legitimate testing firms, but the GAO has lumped them all in together, which will make it easier for pro-regulatory forces to get their hooks into the industry. I urge you to read MacArthur’s entire analysis here, since he follows the industry closely and is saddened by the fact that:
The momentum seems to be well and truly in favour of the bureaucrats now. The prospect of increased regulation (specifically from the FDA) seemed to be enthusiastically received by the Committee today; there was explicit mention of increased money for the FDA to support such a move. The shape of this regulation is as yet unclear, but I’m now extremely pessimistic about the industry’s prospects of escaping excessive, innovation-crushing regulation in the US.
This is very bad news for those of us who wish to see personal medicine flourish.
Was a super-interesting discussion. Recordings of the sessions are up on the web already if you missed them.
During his homily this Easter, Pope Benedict argued that medical science, in trying to defeat death, is leading humanity toward likely condemnation. It’s a position at odds with the value of life, one that the Church will likely revise years from now, replaying the institution’s embarrassment over censoring Galileo.
“Let us reflect for a moment,” Pope Benedict urged, “what would it really be like if we were to succeed, perhaps not in excluding death totally, but in postponing it indefinitely, in reaching an age of several hundred years?” This is a big question, to be sure, but the Pope assumes the answer is obvious. “Humanity would become extraordinarily old,” he said, “there would be no more room for youth. Capacity for innovation would die, and endless life would be no paradise, if anything a condemnation.”
If scientists are successful in finding techniques to rebuild cartilage, repair organs, and cure cancer, people will indeed be living longer — but they will also be healthier, more energetic and youthful. Health-extension, when it happens, will allow people to live longer, better.
Consider that 60-year-olds today are not in the same shape as their counterparts were in the 1800s or 1900s. As humans discovered how to take better care of themselves, through improved nutrition, the use of antibiotics and other techniques, “chronological age” became less synonymous with “biological age.” That is, many of today’s 60-year-olds act and feel much younger than one might expect.
Read more here.
A gene that controls racism appears to exist. However, if you disable it, you get something called Williams syndrome, a disorder where people have problems identifying others with malevolent intentions. Here’s the story, which cites research from Andreas Meyer-Lindenberg of the University of Heidelberg in Germany.
In his Easter homily, Pope Benedict argues that attempting to prolong life is not a goal worthy of our efforts. Here’s how he put it:
Modern medical science strives, if not exactly to exclude death, at least to eliminate as many as possible of its causes, to postpone it further and further, to prolong life more and more. But let us reflect for a moment: what would it really be like if we were to succeed, perhaps not in excluding death totally, but in postponing it indefinitely, in reaching an age of several hundred years? Would that be a good thing? Humanity would become extraordinarily old, there would be no more room for youth. Capacity for innovation would die, and endless life would be no paradise, if anything a condemnation.
Perhaps he’ll change his mind once he reads my book on the subject (yes, it is almost done).
Here’s a rather disturbing article published by CNN today. Apparently, many “states mandate that newborns be tested for anywhere between 28 and 54 different conditions, and the DNA samples are stored in state labs for anywhere from three months to indefinitely, depending on the state.”
I live in California and we did have our baby tested for various genetic conditions before he was born. It wasn’t mandated by the state, but now I wonder what happened to the samples after they were collected.
Here’s more from the CNN article:
In many states, such as Florida, where Isabel was born, babies’ DNA is stored indefinitely, according to the resource center. Many parents don’t realize their baby’s DNA is being stored in a government lab, but sometimes when they find out, as the Browns did, they take action. Parents in Texas, and Minnesota have filed lawsuits, and these parents’ concerns are sparking a new debate about whether it’s appropriate for a baby’s genetic blueprint to be in the government’s possession.
From the NYT:
“The National Institutes of Health said Wednesday that it had approved 13 new human embryonic stem cell lines for use by federally financed researchers, with 96 more under review.”
“Researchers’ interest in human embryonic stem cells has abated since the discovery in 2007 by the Japanese biologist Dr. Shinya Yamanaka that the mature cells of the body can be reprogrammed to the embryonic state.
These induced embryonic cells are highly similar to the real thing but may not be exactly the same. One reason is that the mature cell may perceive the forced walk-back to embryonic state as unauthorized and switch on its anticancer defenses.
Because the reprogrammed cells and those derived from leftover human embryos may not be identical, researchers need to work with both kinds, Dr. Collins said.”
Another innovative idea from Ray Kurzweil. He proposes, “a collaborative technology incubator between Israel and Palestine.” According to reports, the proposal was widely met with enthusiasm and support in both public and private sessions.
Would it work? Maybe, and it probably wouldn’t hurt. It would be nice to see human energy in that part of the world directed at more productive endeavors.
What a weird story. Brings to light the problems that can occur if we start to think that genes explain everything. From the New Scientist:
“A judge’s decision to reduce a killer’s sentence because he has genetic mutations linked to violence raises a thorny question – can your genes ever absolve you of responsibility for a particular act?
In 2007, Abdelmalek Bayout admitted to stabbing and killing a man and received a sentenced of 9 years and 2 months. Last week, Nature reported that Pier Valerio Reinotti, an appeal court judge in Trieste, Italy, cut Bayout’s sentence by a year after finding out he has gene variants linked to aggression. Leaving aside the question of whether this link is well enough understood to justify Reinotti’s decision, should genes ever be considered a legitimate defence?”
Hat tip to Elissa Lynn for forwarding this story.