Results for “fda” 461 found
Assorted links
1. Book preview for 2015. Good stuff, including volume four of Knausgaard, a new Stephenson, a new Gaiman, a new Ishiguro, a Philip Glass memoir, perhaps the Niall Ferguson book on Kissinger will be interesting too. Here is another preview list. And who was nominated for a literary Nobel Prize in 1964.
2. The pick-up culture that is Chinese.
3. Another (right-wing?) view on why the leading public intellectual economists are left-wing. And more from Krugman.
4. Voodoo and Haitian mental health. And the culture that is Singapore.
Printing Cancer Killing Viruses
Cell biologist Andrew Hessel of Autodesk is designing viruses in software to attack a specific individual’s cancer and then using DNA Printers to create the viruses as a drug. Here from an interview with New Scientist (gated).
It’s really about making a specific medicine tailored to one person–“N-of-1” medicine–rather than try to make it a best fit for a whole population. My vision is to create a personalized treatment that can be made in a day by printing bespoke cancer-fighting viruses.
I’m not fully convinced by his economic model but it may be useful as a vision-goal:
I see the business model shifting away from the blockbuster-drug model of the pharma industry–getting the best product for the most people and charging the most for it–to more of a Netflix model, in which you might purchase a subscription for all-that-you-need medicine to manage your cancer.
…I’m pretty sure I can get the virus printing costs down to a dollar a dose. The virus itself is designed by algorithms using diagnostic data from the patient. That info is put into a program that will design the cancer-fighting virus, so the cost of design is cheap. Then there’s testing, and there is no simpler test than on the patient’s own cancer cells in a dish. So that whole process should cost less than $100 end-to-end. If you are on a cancer subscription model paying $100 a month, I see that as ultimately profitable.
Hessel is also far too sanguine about the FDA who he thinks will allow this under “compassionate use.” No way – not today when the FDA prohibits 23andMe from even providing information about DNA and its probable consequences, see my post Our DNA, Our Selves. To make this a reality we will need scientific breakthroughs and also A New FDA for the Age of Personalized Medicine.
Pharmaceutical regulation is getting tougher
From Diana Carew at the Progressive Policy Institute:
…the number of ‘restrictions’ on drug companies increased by 767, or 40% since 2000. This represents a substantial rise in the overall regulatory burden of pharmaceutical companies, which must allocate resources to ensure regulatory compliance. The word “restriction” refers to command clauses such as “shall” and “must,” as contained in sections of the Code of Federal Regulations related to the FDA.
The full study is here (pdf).
Assorted links
1. How Facebook is shaping the news.
2. 1959 Isaac Asimov short essay on how to stimulate creativity.
3. “The Army is conducting a reverse auction for Catholic priest services.”
4. Another superb Michael Hoffman review, this time of Martin Amis on Auschwitz.
5. Ryan Avent on how bad is Amazon? And Joshua Gans on Krugman on Amazon.
6. Richard Preston on Ebola. And David Brooks on why Ebola has taken over our minds.
The new Obama plan to combat antibiotic overuse
The Obama administration on Thursday announced measures to tackle the growing threat of antibiotic resistance, outlining a national strategy that includes incentives to spur the development of new drugs, tighter stewardship of existing ones and a national tracking system for antibiotic-resistant illness. The actions are part of the first major federal effort to confront a public health crisis that takes at least 23,000 lives a year.
The full story is here.
The Hill has more detail. It is an executive order:
The president’s directive creates the Task Force for Combating Antibiotic-Resistant Bacteria, co-chaired by the secretaries of Defense, Agriculture and Health and Human Services.
The group is charged with implementing a plan to track and prevent the spread of antibiotic-resistant bacteria, promote better practices for the use of current drugs and push for a new generation of antibiotic medications.
To that end, the White House on Thursday announced a $20 million prize “to facilitate the development of rapid, point-of-care diagnostic tests for healthcare providers to identify highly resistant bacterial infections.”
The added incentive and the timeframe given to the task force indicate the urgency with which the administration is acting, said Dr. Eric Lander, who co-chairs the President’s Council of Advisors on Science and Technology.
“This is a pretty tight timeline to now come up with a national game plan,” Lander said.
There is also this:
In December, the Food and Drug Administration (FDA) unveiled a plan to phase out the use of antimicrobials for the purpose of fattening chickens, pigs or other animals destined for human consumption. But the plan relies in part on voluntary industry cooperation, and advocates argue the government’s efforts are lagging behind even some industry players.
Here is the new full 78 pp. report to the President on antibiotic resistance (pdf).
This initiative — or its failure — is potentially a more important health issue than Obamacare, yet it will not receive 1/1000th of the attention. Without reliable antibiotics, a lot of now-routine operations would become a kind of lottery.
Here are previous MR posts on antibiotic resistance. I would note it is difficult to judge such a plan at the current level of detail. It is better than nothing, but any initial plan is going to be not nearly enough, relative to an ideal. By the way, Alex tells me there is also a British prize, discussed here.
Co-opting Regulation for Profit
Regulations often increase monopoly power. Indeed, increasing monopoly power is often why regulations are enacted. In other cases, however, ostensibly neutral regulations are co-opted by entrepreneurs who spot an opportunity to leverage the regulation for profit. Derek Lowe points us to an interesting case of the latter involving drug pricing and the FDA.
Retrophin recently purchased the marketing rights to the drug Thiola and they are increasing the price from $1.50 per pill to over $30 per pill. Surprisingly, Thiola is off-patent. Ordinarily, we would expect such a large price increase to be met with entry and price pushed to marginal cost. To enter into the market, however, a generic producer must prove bio-equivalence which requires that the generic producer obtain a small quantity of the branded drug. Branded drug firms don’t like competition from generics and they try to impede the process but it’s typically not a big deal for a generic producer to obtain some of the branded drug for their bio-equivalence trials.
In 2007, however, the FDA was officially authorized to approve drugs conditional on the firm implementing a Risk Evaluation and Mitigation Strategy (REMS). The FDA approved thalidomide, for example, only if physicians signed a patient-physician agreement and enrolled each of their patient’s directly with the producer. Indeed, a unique prescription authorization number was required for each prescription which could be filled only at specially authorized pharmacies. The idea, of course, was to prevent anyone from taking thalidomide during pregnancy. The purpose of the regulation was probably not to create monopoly power but it didn’t take firms long to realize that REMS regulations could be co-opted. Simply put, a REMS agreement can make it illegal for generic firms to obtain a sample of the branded drug through ordinary channels. In the thalidomide agreement, for example, it’s even the case that all unused thalidomide must be returned to the producer! Retrophin is hoping to use a similar REMS strategy to keep generic competitors out of the market for Thiola.
Addendum: Derek’s post aroused the ire of the CEO of Retrophin and may have gotten him banned from reddit.
The decline of the week-long vacation (America fact of the day)
Nine million Americans took a week off in July 1976, the peak month each year for summer travel. Yet in July 2014, just seven million did. Keeping in mind that 60 million more Americans have jobs today than in 1976, that adds up to a huge decline in the share of workers taking vacations.
Some rough calculations show, in fact, that about 80 percent of workers once took an annual weeklong vacation — and now, just 56 percent do.
That is from Evan Soltas, there is more here. And Evan offers a bit more here.
Innovation Breakdown
From my review today in the WSJ of Innovation Breakdown by Joseph Gulfo:
Yo is a smartphone app. MelaFind is a medical device. Yo sends one meaningless message: “Yo!” MelaFind tells you: “biopsy this and don’t biopsy that.” MelaFind saves lives. Yo does not. Guess which firm found it easier to put their product in consumers hands? Oy.
In “Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances,” Joseph Gulfo tells the tumultuous history of MELA Sciences, the company that invented MelaFind. When Dr. Gulfo joined the firm as president and CEO in 2004, the company’s brilliant team of scientists had spent many years and tens of millions of dollars to develop MelaFind, a “camera with a brain”—optical technology that would scan potential melanomas in multiple spectra and then, using sophisticated algorithms and large datasets, diagnose which were most likely to be cancerous.
MELA Sciences conducts an extensive clinical trial according to a protocol agreed on by the FDA and all looks good. After the clinical trial is completed, however, the FDA backs away from the protocol and comes out against MelaFind.
…The title of Dr. Gulfo’s book is “Innovation Breakdown” but “Innovator’s Breakdown” might have been more apt. The letter sent the author into survival mode. He battled the FDA, calmed investors, and defended against the lawsuit all while trying to keep the company afloat. Under stress, Dr. Gulfo’s health began to decline: He lost 29 pounds, his hair began to fall out, and the pain in his gut became so intense he needed an endoscopy. When his wife begged him to quit, he refused. They turned into roommates. “We were nothing more than cordial. I basically shut my wife out of my life,” he writes.
…The climax to this medical thriller comes when, in “the greatest 15 minutes of [his] life,” Dr. Gulfo delivers an impassioned speech, à la “Twelve Angry Men,” to the FDA’s advisory committee. The committee voted for approval, 8 to 7, and, perhaps with the congressional hearing in mind, the FDA approved MelaFind in September 2011.
It was a major triumph for the company, but Dr. Gulfo was beat. He retired from the company in June 2013—just in time to save his marriage.
Yet remarkably, given his experience, Mr. Gulfo writes that he still believes in a strong FDA. He argues in the book that better “leadership” and a few tweaks to existing rules can fix the problem. He’s wrong.
Compare MelaFind’s experience in the U.S. with its reception in Europe: MelaFind was submitted for marketing approval in Europe in May 2011. It was approved just five months later. One key reason for Europe’s efficient approval process is that European governments don’t review medical devices directly. Instead they certify independent “notified bodies” that specialize and compete to review new products. The European system works more quickly than the U.S. system, and there is no evidence that it results in reduced patient safety. Rather than tweak the current system, why doesn’t the U.S. just adopt the European model and call it a day? Our health and our economy would be better off for it.
Google’s Sergey Brin recently said that he didn’t want to be a health entrepreneur because “It’s just a painful business to be in . . . the regulatory burden in the U.S. is so high that I think it would dissuade a lot of entrepreneurs.” Mr. Brin won’t find anything in Dr. Gulfo’s book to persuade him otherwise. Until we get our regulatory system in order, expect a lot more Yo’s and not enough life-saving innovations.
The FT summer book reading list
War: What is it Good for? The Role of Conflict in Civilisation, from Primates to Robots, by Ian Morris, Profile, RRP£25/ Farrar, Straus and Giroux, RRP$30
In this remarkable book, historian Morris argues not only that war is a source of technological advance but that it brings peace. Through war, more powerful and effective states emerge and these in turn do not merely offer the blessings of peace, but impose it. The thesis is disturbingly persuasive. But, in a nuclear age, the great powers will have to try something else.
The full list is here, possibly gated. They also recommend the Adam Tooze book on the post WWI era, which I now have finished and really like and also find to be quite Sumnerian. Adam Minter’s Junkyard Planet is an excellent read as well.
All hail Khan!
Congratulations to Razib Khan, the noted genetics blogger, on the birth of his son. Born just last week, Razib’s son is already making the news:
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.
Razib, a graduate student at a lab at UC Davis in California, had some genetic material from his in-womb son from a fairly standard CVS test.
When Khan got the DNA earlier this year, he could have ordered simple tests for specific genes he was curious about. But why not get all the data? “At that point, I realized it was just easier to do the whole genome,” he says. So Khan got a lab mate to place his son’s genetic material in a free slot in a high-speed sequencing machine used to study the DNA of various animal species. “It’s mostly metazoans, fish, and plants. He was just one of the samples in there,” he says.
The raw data occupied about 43 gigabytes of disk space, and Khan set to work organizing and interpreting it. He did so using free online software called Promethease, which crunches DNA data to build reports—noting genetic variants of interest and their medical meaning. “I popped him through Promethease and got 7,000 results,” says Khan.
Promethease is part of an emerging do-it-yourself toolkit for people eager to explore DNA without a prescription. It’s not easy to use, but it’s become an alternative since the FDA cracked down on 23andMe.
Craig Venter was the first person to have his genome sequenced, that was in 2007. Now, just seven years later, costs have fallen by a factor of 10,000. Personal genome sequencing is going to become routine regardless of the FDA.
Why Vampires Live So Long
NYTimes: Two teams of scientists published studies on Sunday showing that blood from young mice reverses aging in old mice, rejuvenating their muscles and brains. As ghoulish as the research may sound, experts said that it could lead to treatments for disorders like Alzheimer’s disease and heart disease.
The key papers are here and here and here. Some of the papers are pointing to a specific protein but the last paper suggests that simple transfusions also work and that raises a number of issues of public policy. As Derek Lowe notes:
Since blood plasma is given uncounted thousands of times a day in every medical center in the country, this route should have a pretty easy time of it from the FDA. But I’d guess that Alkahest is still going to have to identify specific aging-related disease states for its trials, because aging, just by itself, has no regulatory framework for treatment, since it’s not considered a disease per se.
…You also have to wonder what something like this would do to the current model of blood donation and banking, if it turns out that plasma from an 18-year-old is worth a great deal more than plasma from a fifty-year-old. I hope that the folks at the Red Cross are keeping up with the literature.
Gunshot Victims to be Put into Suspended Animation
A hospital in Pennsylvania will soon begin clinical trials to put gunshot or other accident victims into a state of suspended animation while their organs are repaired. By all measures the people suspended will be dead for hours but with luck many will be brought back to life.
The first step is to flush cold saline through the heart and up to the brain – the areas most vulnerable to low oxygen. To do this, the lower region of their heart must be clamped and a catheter placed into the aorta – the largest artery in the body – to carry the saline. The clamp is later removed so the saline can be artificially pumped around the whole body. It takes about 15 minutes for the patient’s temperature to drop to 10 °C. At this point they will have no blood in their body, no breathing, and no brain activity. They will be clinically dead.
In this state, almost no metabolic reactions happen in the body, so cells can survive without oxygen. Instead, they may be producing energy through what’s called anaerobic glycolysis. At normal body temperatures this can sustain cells for about 2 minutes. At low temperatures, however, glycolysis rates are so low that cells can survive for hours. The patient will be disconnected from all machinery and taken to an operating room where surgeons have up to 2 hours to fix the injury. The saline is then replaced with blood. If the heart does not restart by itself, as it did in the pig trial, the patient is resuscitated. The new blood will heat the body slowly, which should help prevent any reperfusion injuries.
The technique will be tested on 10 people, and the outcome compared with another 10 who met the criteria but who weren’t treated this way because the team wasn’t on hand. The technique will be refined then tested on another 10, says Tisherman, until there are enough results to analyse.
No one knows how long people can be maintained in suspended animation before revival is impossible. We know from accidents where people drown in icy lakes that suspended animation can work for at least half an hour and experiments on pigs suggest no cognitive defects from revived animals suspended for up to an hour, mice have been suspended for up to six hours and roundworms for up to 24 hours. If the initial trials are successful, further experiments will likely discover ways to lengthen the period of suspended animation in humans and perhaps suggest improvements to current cryonic techniques.
Hat tip: Noah Smith.
Most Popular MR Posts of 2013
Here is my annual round-up of the most popular MR posts of 2013 as measured, somewhat eclectically, using the number of links, tweets, shares, comments and so forth. Sadly, the post that was most linked to this year was by neither Tyler nor myself but by… Tyrone.
- Tyrone on why the government shutdown and the debt ceiling crisis were brilliant Republican strategy
Look people, I have explained this before. Tyrone is a bad man. Do Not Encourage Tyrone. Fortunately for us Tyrone doesn’t like it when people like him.
Second most highly linked was my post No One Is Innocent. I was also pleased that a related post, Did Obama Spy on Mitt Romney?, was also highly linked although I think that the question raised in this post about the potential for NSA tools to be abused for political purposes hasn’t been truly addressed in the main stream media. Conor Friedersdorf at The Atlantic in The Surveillance State Puts U.S. Elections at Risk of Manipulation was one of the few people to pick up on this important question.
Also highly linked were my post The Great Canadian Sperm Shortage and a few less substantive items drawn mostly from elsewhere such as Equal Population US States and What is the Most Intellectual Joke You Know.
If you followed Tyler’s timely advice in another highly linked post, China, and the soaring price of Bitcoin, you would have saved yourself from a big loss (albeit you would have made an even bigger profit by ignoring Tyler’s earlier advice).
The most shared post was Tyler’s Stereotyping in Europe with over seven thousand shares, followed by Nobody dislikes inflation more than strippers. I was pleased that a bunch of my substantive posts were highly shared including:
- My letter to my son’s high school principal, High School Safety in Northern Virginia
- Sinister Statistics: Do Left Hand People Die Young, a neat piece of statistical reasoning and
- The Animals are also Getting Fat.
Another highly shared and commented upon post was Our DNA, Our Selves on the FDA and 23andMe. Mark my words, when this or similar case goes to court the FDA will eventually lose on free speech grounds.
Gun posts get lots of comments including The Culture of Guns, The Culture of Alcohol, Guns, Suicide and Natural Experiments, Firearms and Suicides and How Japan Does Gun Control.
Question posts such as Who is the Worst Philosopher? and Who is the most influential public intellectual of the last twenty-five years? get lots of comments as did Who is Juan Galt?
There is overlap between most linked, shared, and commented so some of the above would fit in several categories but it’s surprisingly weak. Posts with a lot of comments, for example, often do not draw lots of links.
What were your favorite posts of 2013? And what requests do you have for 2014?
Assorted links
1. Eurozone industrial production: the recovery?
2. Are Chinese provinces picking up the stimulus slack?
3. Yuval Levin has a good analysis of the sequester redo.
4. Fama and Shiller, on each other.
5. Average is Over in farming. And the FDA restricts antibiotic use in livestock.
Why I didn’t do 23andMe
I had a free voucher from the summer, but decided not to go ahead with a saliva test. Here are my reasons:
1. I thought there is option value and I can always do a test later, for a better and more accurate service. (I hadn’t thought of the FDA shutting the whole thing down, but still I expect the service will return in some manner, if only under another corporate banner or from overseas.)
2. I thought the “worry cost” of negative information would exceed the benefit of whatever specific preventive measures I might take. Most useful ex ante preventive measures, such as diet and exercise, are fairly general in their application and I didn’t think there was likely much to be learned about specific measures for specific potential maladies. And here is an interesting short piece on the likelihood of false negatives.
3. One might take more preventive measures with one’s ex ante and more uncertain knowledge than with one’s ex post and more certain knowledge. For instance an absence of negative information might have encouraged me to slack on exercise, to the detriment of my eventual health outcomes.
4. I wouldn’t describe privacy concerns as my major worry, but at the margin still they counted for something. I felt eventually this service would prove equivalent to making my genome public information, via something called GenomeLeaks or the like. Why do that without having a better sense of its longer-run implications?
I’m glad I didn’t do it, glad I had the choice to decline to do it, and I am still feeling no temptation to do it in the future. I do feel a slight amount of guilt for not contributing to a future “Big Data” project, but so be it. I also am glad I am not contributing to some of the inevitably unethical uses to which eugenics will be put, and that is more than a counterbalance, given that I expect no practical benefit from reading my own test results.