The following links are just news items and opinions that pass my desk throughout the week. I don’t necessarily support or advocate any of the items, they are just interesting reads.
Taxing Services: A Step In The Right Direction – Much noise has been made over the years about California’s unfriendly tax environment. But an ongoing mantra at Beacon Economics is that California is not so much a ‘high’ tax state as a ‘dumb’ tax state. In other words, it is the structure of revenues that creates the problem, not simply the quantity being collected. This is important because it suggests that if we make certain logical changes to the structure of taxes in the state, it could simultaneously make California more business friendly while helping to cure the long-term deficit issues we still face – despite the current ‘balanced’ budget.
What constitutes a ‘smart’ revenue system? We would start with three basic principals:
- Non-Distortionary: Taxes should be focused in places where they have a minimum possible impact on the functioning of markets. From this perspective the rule of thumb is small taxes on wide bases. It also means that taxes should be easy to collect.
- Fairness: By this we mean that taxes should, in general, be progressively structured. But it also means that the tax burden is spread equally across individuals with roughly similar means.
- Predictability: Governments need to plan ahead, and having steady revenue sources are a huge help in such a planning process. It also helps to limit the pain that is felt in years when the economy slows or contracts.
California fails miserably on all three of these tests. Read More > at Beacon Economics
Armour: He’s 12 years old, not the next Tom Bardy – His profile on a top recruiting website touts him as a “pro-style quarterback.” His blog breathlessly recounts his accomplishments and the rave reviews of those who’ve seen him play.
All-American. MVP. “Future Tom Brady in action!” “Daron is the man fa real. Accurate, good technique, can take a hit.” “Daron is my fav QB in the nation.”
Impressive accolades if Daron Bryden is a top college prospect — but he’s a sixth-grader. A 5-2, 105-pound wisp of a kid whose only concern at this age should be where to have his next birthday party, not trying to impress scouts and coaches for a scholarship or career that might or might not materialize.
Yet Daron is hardly unique. In every sport, in every community, youth sports for some families have become a junior farm system with travel teams, single-sport specialization and heightened expectations that no kid should have to shoulder before he gets his driver’s license.
…Treating kids as if they’re on the fast track to a scholarship or the pros won’t make it a reality any more than buying a Powerball ticket will make you a millionaire. If they’re as gifted as you think they are at 9 or 12, that will still be the case when they’re 16.
What’s the harm in letting kids be kids for a little while longer? It doesn’t cost anything. In fact, it’s priceless. Read More > in USA Today
Did El Cerrito officials deceptively use public funds for tax-hike campaign? – Officials in the city of El Cerrito deceptively used public funds to push for a hike in the city sales tax. That is the charge being made by local newspaper columnist Daniel Borenstein.
Last year, city voters approved a measure that increased the local sales tax to the top rate in the state. But Borenstein alleges the city aided the campaign in a deceptive, if not illegal way.
…In addition to using city staff time, El Cerrito spent $76,000 on legal advice, consultants, pollsters and mailers. Governments can legally spend public money on informational campaigns, but they cannot ask someone to vote yes or no. Documents show that city officials and consultants took care not to cross that line. But they weren’t balanced and transparent. Read More > at California City News
The 7 Best Facebook Alternatives You Didn’t Know About – People are connecting on more than just Facebook, LinkedIn, and Twitter
Your Facebook friends are boring. Your Twitter followers sound like a bunch of parrots. And your LinkedIn contacts, well, who wants to talk about work all day, anyway? Amazingly, in 2015, it’s still possible to feel like you’ve reached the end of the Internet, especially if you rely on your social networks for news and amusement.
But there are more ways to connect with people online than the three most popular social networks. In fact, smaller networks are some of the best places to dig into topics you care more deeply about. So sign up and check out at one of these great alternative social networks:
App.net: Two of the largest complaints about Facebook are how the company gives your data to third party applications, and the way the company manipulates its News Feed to show things that aren’t necessarily updates from your friends.
BeMyEyes: Technically speaking, BeMyEyes is not a social network. That said, it provides one of the most intimate interactions you’ll ever have with another person via technology. Designed to help blind people to solve everyday problems, the iPhone app connects the vision-impaired with fully-sighted users via video chat. Read More > at TIME
Supreme Court to hear religious freedom case – Samantha Elauf was apprehensive to interview for a sales job at retailer Abercrombie & Fitch in 2008 because the 17 year old wore a headscarf in accordance with her Muslim faith. But a friend of hers, who worked at the store, said he didn’t think it would be a problem as long as the headscarf wasn’t black because the store doesn’t sell black clothes.
Ultimately Elauf failed to get the job, and her story has triggered a religious freedom debate regarding when an employer can be held liable under civil rights laws. The Supreme Court heard arguments in the case on Wednesday.
Like many retailers Abercrombie has a “look policy” aimed to promote what it calls its “classic East Coast collegiate style of clothing.”
When Elauf sat down with assistant manager Heather Cooke to formally interview for the job, neither the headscarf nor religion ever came up. Cooke did refer to the policy, however, telling Elauf that employees shouldn’t wear a lot of make up, black clothing or nail polish.
Cooke thought Elauf was qualified for the job, but after the interview sought approval from her district manager regarding the headscarf. She says she told the manager that she assumed Elauf was Muslim and figured she wore the headscarf for religious reasons. The manager told her that Elauf should not be hired because the scarf was inconsistent with the “look policy.”
A federal agency, the Equal Employment Opportunity Commission sued on Elauf’s behalf saying the store had discriminated on the basis of religion in violation of Title VII of the Civil Rights Act of 1964. Read More > at CNN
First human head transplant could happen in two years – A radical plan for transplanting a head onto someone else’s body is set to be announced. But is such ethically sensitive surgery even feasible?
IT’S heady stuff. The world’s first attempt to transplant a human head will be launched this year at a surgical conference in the US. The move is a call to arms to get interested parties together to work towards the surgery.
The idea was first proposed in 2013 by Sergio Canavero of the Turin Advanced Neuromodulation Group in Italy. He wants to use the surgery to extend the lives of people whose muscles and nerves have degenerated or whose organs are riddled with cancer. Now he claims the major hurdles, such as fusing the spinal cord and preventing the body’s immune system from rejecting the head, are surmountable, and the surgery could be ready as early as 2017. Read More > at New Scientist
Assembly Democrats Want Real Estate Fees, Tax Credits for Affordable Housing – The leader of the state Assembly is unveiling an ambitious affordable housing proposal, one that could pump more than $600 million a year into development at the local level.
Assembly Speaker Toni Atkins (D-San Diego) was joined Wednesday afternoon by a wide range of prominent Democrats in Los Angeles, including state Treasurer John Chiang and Los Angeles Mayor Eric Garcetti, to announce her plan. At its center: A proposal to institute a new transfer fee on real estate transactions, one Atkins’ staff characterizes as small; and expanding legislation proposed by Assemblyman David Chiu (D-San Francisco) to increase the tax credit that real estate developers can claim when they build affordable housing.
…As we reported this morning, local officials have been scrambling to plug the $1 billion annual hole left by Gov. Jerry Brown’s dissolution of redevelopment agencies four years ago.
They aren’t new ideas. In 2013, former Bay Area state Sen. Mark DeSaulnier, now a member of Congress, first floated the idea of a $75 transfer tax to fund affordable housing. SB391 died in the Assembly, but early estimates projected it could raise $300 million to $700 million a year at the $75 rate. Many business groups backed the proposal. Read More > at KQED
San Francisco’s version of the war on drugs – I can’t tell you how many times I’ve had out-of-towners tell me they think San Francisco is a breathtakingly beautiful city — so why is it that City Hall hasn’t done more about baseball pitchers chewing tobacco at city ballparks? No wait, I can tell you. I’ve never heard that. I have heard countless complaints from tourists and locals about homeless people sprawled on sidewalks, the stink of the city and the creepiness of walking downtown while navigating around urine puddles, feces and used hypodermic needles.
Given those very real assaults on the city’s quality of life, Supervisor Mark Farrell’s plan to introduce an ordinance banning the use of chewing tobacco at every ballpark in town comes across as a veritable trivial pursuit.
Farrell admits that his proposed ban is groundbreaking, as tobacco chewers pose no health risk to others. Smoking foes have cited the health threat of secondhand smoke to justify smoking bans — but secondhand saliva?
…Farrell’s ordinance qualifies as a nanny state law because: (a) like other City Hall busybody schemes, it targets a small group of people who do something politically unpopular, as in chew tobacco or drink too much soda, and (b) unlike drug injectors and public defecaters, practitioners tend to be law-abiding. In other words, Farrell and Assemblyman Tony Thurmond, D-Richmond, who has a state bill to ban smokeless tobacco at ballparks, are picking on easy, law-abiding targets who cannot count on the powerful homeless lobby to safeguard their interests.
Governments should not use their heavy hand to outlaw behavior simply because elected officials can get away with it. Farrell says ballplayers who chew tobacco set a bad example. Does City Hall really want to sic law enforcement on citizens for setting a bad example? Where does that end? Read More > in the San Francisco Chronicle
Cybergeddon: Why the Internet could be the next “failed state” – In the New York City of the late 1970s, things looked bad. The city government was bankrupt, urban blight was rampant, and crime was high. But people still went to the city every day because that was where everything was happening. And despite the foreboding feelings hanging over New York at the time, the vast majority of those people had at most minor brushes with crime.
Today, we all dabble in some place that looks a lot like 1970s New York City—the Internet. (For those needing a more recent simile, think the Baltimore of The Wire). Low-level crime remains rampant, while increasingly sophisticated crime syndicates go after big scores. There is a cacophony of hateful speech, vice of every kind (see Rule 34), and policemen of various sorts trying to keep a lid on all of it—or at least, trying to keep the chaos away from most law-abiding citizens. But people still use the Internet every day, though the ones who consider themselves “street smart” do so with varying levels of defenses installed. Things sort of work.
Just like 1970s New York, however, there’s a pervasive feeling that everything could go completely to hell with the slightest push—into a place to be escaped from with the aid of a digital Snake Plissken. In other words, the Internet might soon look less like 1970s New York and more like 1990s Mogadishu: warring factions destroying the most fundamental of services, “security zones” reducing or eliminating free movement, and security costs making it prohibitive for anyone but the most well-funded operations to do business without becoming a “soft target” for political or economic gain.
That day is not yet nigh, but logic suggests the status quo can’t continue forever. The recent rash of major breaches of corporate networks, including the theft of personal information from the health insurer Anthem and the theft of as much as a billion dollars from over 100 banks are symptoms of a much larger trend of cybercrime and espionage. And while the issue has been once again raised to national importance by the White House, it could be argued that governments have done more to exacerbate the problem than address it. Fears of digital warfare and crime are shifting budget priorities, funding the rapid expansion of the security industry and being used as a reason for proposals for new laws and policy that could reshape the Internet. Read More > at ars technica
Obama’s Oil-by-Rail Boom – …A business that barely existed when he took office now moves an impressive million barrels a day. The oil pouring forth from America’s resurgent fields, after all, has to reach market somehow. And as the Journal explained in December, political opposition to the Keystone XL pipeline has “emboldened resistance to at least 10 other pipeline projects across North America. . . . The groups coordinate their moves in regular conference calls and at meetings in Washington, D.C., and elsewhere.”
The publication Energy Monitor Worldwide elaborated in September: “Environmentalists and governments are making it more and more difficult to get approval to build pipelines, so producers are increasingly using rail to get their oil to refineries for processing into products that the American public needs. . . . If all the railcars carrying crude oil on a single day were hitched together to a single locomotive, that train would be about 17 miles long.”
…All the more newsy, then, is Mr. Obama’s unsurprising veto of bipartisan legislation that would have authorized the Keystone XL pipeline. Opposing Keystone, it goes without saying, will not make the slightest difference to things opponents claim to care about. It will not alter by an infinitesimal fraction of a degree mankind’s reliance on fossil fuels or the continued development of hydrocarbon resources.
It will, however, give fresh impetus to America’s oil-by-rail boom. Read More > in The Wall Street Journal
Bill to ban BART strikes is introduced by Republican lawmaker – A freshman state lawmaker from the East Bay has introduced a bill to ban BART strikes such as the two walkouts that caused commuter chaos for eight days in 2013.
The bill faces a steep uphill struggle in a Democratic-controlled Legislature.
Assemblywoman Catharine Baker, R-Dublin, is not deterred, saying she believes she can get the bill passed by focusing on how damaging BART strikes are to commuters, traffic congestion and the economy.
“When something is this important, I believe we have to act,” Baker said Tuesday in announcing her bill. “I made it my first piece of legislation to introduce.”
Assembly Bill 528 would bar BART workers from striking after their contracts expire as long as they continue to get wages and benefits. Read More > at Inside Bay Area News
Ticking clock: California redistricting in SCOTUS’ hands – A case before the U.S. Supreme Court, with arguments set to be heard on March 2, could reduce the role of the State Redistricting Commission, invalidate the 2011 Congressional lines, and hand to the legislature the immediate responsibility of redrawing 53 valuable seats.
The case, born out of the Arizona Legislature’s frustration with their own commission, will decide if the U.S. Constitution’s requirement that the state legislators draw congressional districts can be given to an independent commission through a ballot measure. If the commission is ruled unconstitutional, Arizona and each state with a similar commission, such as California, would have to perform a mid-decade redraw of their Congressional Districts, while legislative and other offices would not be impacted.
Mid-decade redistrictings are rare and generally very contentious. Read More > in Capitol Weekly
California’s plastic-bag ban suspended by ballot referendum – Setting up a grand environmental showdown, a referendum initiated by the plastic-bag industry to overturn California’s first-in-the-nation law that bans supermarkets and other businesses from handing out single-use plastic bags has qualified for next year’s ballot.
The immediate impact of Tuesday’s announcement by Secretary of State Alex Padilla is that the law, signed by Gov. Jerry Brown in September, will be suspended until the voters decide its fate in the November 2016 election.
The statewide ban, hailed by environmental groups as a way to reduce litter and ocean pollution, had been scheduled to go into effect in July. But large companies that manufacture plastic grocery bags, led by Hilex Poly of South Carolina, said the measure would harm the state’s economy and that it unfairly allowed grocers to charge customers 10 cents per paper bag. Read More > in the Associated Press
Superfish and the Sordid History of Selling Customers’ Online Privacy Out From Under Them – About the nicest thing you can say about Lenovo shipping some of its computers with Superfish adware that fatally compromised its online security is this: It wasn’t the first.
There’s a rich history of manufacturers who tried to eke out a few advertising bucks from products their customers had already paid for.
Lenovo merely failed at this ambition more catastrophically than most.
The Superfish flop
Superfish, if you missed the first round of stories, uses image-recognition software to identify pictures you’re looking at online and then presents ads for the same things. That alone might sound sketchy, and usually a browser would block this kind of snooping. Superfish got around this by using a security certificate it signed itself to fool your browser into letting it watch secure Web traffic.
The Department of Homeland Security’s Computer Emergency Readiness Team (CERT) labeled this tactic “a classic man-in-the-middle attack” that an attacker could easily exploit for eavesdropping.
That CERT alert warns that you’d get no warning from your browser if somebody tapped into Superfish and started peeking at your e-mail or online banking. It urges a prompt removal of Superfish. If you have a Lenovo laptop, you can check your computer for this vulnerability at https://filippo.io/Badfish/. Read More > at Yahoo! Tech
Thompson: Take emotion out of Raiders stadium issue – …New Oakland Mayor Libby Schaaf and local government officials might be tempted to put up taxpayer money, disguised in jargon. Who wants to lose the Raiders on their watch? But everyone involved needs to come to grips with this new reality of big sports business.
Prices have gotten way too high for municipalities to kick in. These games now can be played only by members of the billionaires club, those who have access to ridiculous dough and lose millions in their couch cushions. This is not a game for politicians beholden to constituents and school systems and firefighters.
Especially not for financially strapped cities such as Oakland, laden with core problems that take precedence over the Raiders’ need for a new porch.
…It’s doubtful, after all these years, that locals leaders can come up with a better plan for the Raiders. The city is already paying $20 million a year for the Coliseum renovation when the Raiders came back in 1995. And Schaaf is on the record saying the public will pay for the infrastructural improvements to make the area fit for a new stadium. That’s a price tag that could be upward of $300 million. Already too much.
On top of that, local officials have to find $600 million, to combine with Davis’ share, to fund the actual stadium.
Perhaps the funding would be possible if not for the inept politicians in the way. That wouldn’t be the least bit surprising. But that is only further proof this process is too big for these local officials and that Davis needs to make this happen on his own.
If that means the Raiders need to go, so be it. Read More > in the San Jose Mercury News
How to Tell if You’re a Jerk at Work – …If self-awareness is so important, why do so many people lack it? One reason is because other people often don’t serve up clear signals. Some of this reflects politeness and white lies (“Your presentation looks great!”). Other skewed signals stem from tactical motives, like ingratiation (“Of course you’re the best manager in the division, boss”).
This warped and ambiguous feedback then runs up against two of our own internal tendencies: We often make self-flattering assumptions, and we expect others will agree with us: “I think I’m a good, effective, talented person…and so others must see me that way, too.” Repeat something like that enough times and it can become a force field, deflecting the occasional true signal that does head your way.
Drawing on the insights of social scientists, and our own research, we offer four suggestions that can help people become more self-aware.
Ask People to Fire Away
One effective way to raise self-awareness is to gather anonymous assessments from peers and colleagues, with the results collected into an overall report that doesn’t identify who said what.
Ratings can be revealing—but try to ask open-ended questions as well. Give people a chance to write extended answers, instead of just choosing a response on a rating scale. To avoid mushy and ambiguous remarks, ask people to discuss concrete behaviors, and separate out open-ended questions seeking input on effective behaviors from those aiming for comments about problematic behaviors or development areas. Read More > in The Wall Street Journal
Early exposure to peanuts helps prevent allergies in kids – For years, parents of babies who seem likely to develop a peanut allergy have gone to extremes to keep them away from peanut-based foods. Now a major study suggests that is exactly the wrong thing to do.
Exposing infants like these to peanuts before age 1 actually helped prevent a peanut allergy, lowering that risk by as much as 81 percent, doctors found. Instead of provoking an allergy, early exposure seemed to help build tolerance.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, called the results “without precedent” and said in a statement that they “have the potential to transform how we approach food allergy prevention.”
A big warning, though: The babies in the study were checked to make sure they didn’t already have a peanut allergy before they were fed foods that included peanuts, so parents of babies thought to be at risk for an allergy should not try this on their own. Read More > in the Associated Press
Lawmakers want probe of SF archdiocese’s 4 high schools – Two California lawmakers who called the San Francisco archbishop’s morality clauses discriminatory are asking for a probe of working conditions at four San Francisco Bay Area Catholic high schools.
Democratic Assemblymen Phil Ting of San Francisco and Kevin Mullin of San Mateo say the clauses set a dangerous precedent for workers’ rights.
On Monday, they urged the Assembly’s Labor and Employment and Judiciary Committees to conduct the probe.
The request follows an exchange of letters between the assemblymen and San Francisco Archbishop Salvatore Cordileone.
The lawmakers asked the archbishop to remove the “divisive and discriminatory” clauses from a teachers’ handbook.
Cordileone answered they need to respect his right to hire people who uphold Catholic teachings. Read More > from the Associated Press
Disney raises ticket prices for U.S. theme parks – how far off will $100 a day be for Disneyland? – Visiting the Happiest Place on Earth just got more expensive.
With record attendance at its theme parks, Disney said starting Sunday it would raise ticket prices across the board for the Disneyland Resort here and at Walt Disney World in Florida.
An adult one-day ticket to Disneyland or Disney California Adventure will rise from $96 to $99. A one-day park hopper add-on will increase from $54 to $56.
Tickets for children ages 3 to 9 will climb from $90 to $93. A price for a Premium annual pass with parking and no blackout dates will go up 11 percent, from $699 to $779.
Some parkgoers were frustrated, even outraged, at the news, taking to social media to sound off. Read More > in the Orange County Register
Imagining ‘Prostitution 3.0’ – Adam Ozimek of Modeled Behavior asks: Why is there no Uber for prostitution? “Customers could receive ratings, so could prostitutes, and payments could be done in a safer way that does not involve cash,” he writes. The short answer to why this doesn’t exist, of course, is because prostitution remains illegal in most of the United States, as does promoting or aiding prostitution—a designation that could ensnare anyone inclined to launch or run an Uber-like sex-trade app.
In a new Iowa Law Review article, “Prostitution 3.0,” University of Colorado law professor Scott Peppet explores the issue in more depth, laying out the myriad benefits of a “technology-enabled sex market” as well as the legal barriers that “inhibit prostitution-related innovation” in America. First, the benefits of better apps and screening tools:
“It could help prostitutes by deterring “no shows” and non-paying customers. It could reduce illegal trafficking and coerced prostitution by screening prostitutes for age and legal status, and by using biometric identification to confirm that the prostitute the client hired online was in fact the same individual who appeared in person. It could enable and encourage prostitutes and clients to find and engage each other off the streets and out of view. It could preserve anonymity for both prostitutes and customers, allowing them to avoid social stigma and maintain privacy. It could be conducted by a private (perhaps non-profit) firm, not the government, greatly reducing the risk to either party that the state might in some way exploit the information provided.” Read More > at Reason.com
They Gave an Election in LA and Almost Nobody Came – It seems Los Angeles County is testing the old philosophical question: What if they gave an election and nobody came? The most populous county in the state had the lowest percentage turnout in last November’s election. While 42% of state voters turned out for the general election, Los Angeles County turnout was only 31%. The last mayoral city election in Los Angeles saw a turnout of a mere 23%.
The Senate and Assembly election committees chaired by Senator Ben Allen and Assemblymember Sebastian Ridley-Thomas called a joint oversight committee hearing to look for the reasons and solutions of the extremely low turnout in L.A. County. The answer just might be a feeling of powerlessness amongst the voters.
…Still, Professor Raphael Sonenshein, Executive Director of the Pat Brown Institute at Cal State, Los Angeles, may have touched on the reason citizens don’t engage in local elections. He argued that people believe the only election that really leads to change is the presidential election.
If that is so, then many of the suggestions made to increase the vote will probably only do so on the margins. Even if voting is made as convenient as possible — as Jessica Levinson suggested the time might come when everyone can simply vote by pressing some button on their iPhone — an important question remains: Do voters think those votes for local candidates create change? – Read More > at Fox and Hounds
FBI Joins Fraud Investigation of Bay Area Public Housing Agency – A government probe into allegations of nepotism and fraud at the Richmond Housing Authority has expanded, with local police now joined by a team of FBI agents, federal housing investigators and county prosecutors.
Capt. Mark Gagan of the Richmond Police Department said the focus of their investigation is Debra Holter, the agency’s asset specialist, who heads the maintenance department for the East Bay city’s dilapidated public housing.
“They’re looking into how the housing authority approved contracts and the accounting of assets and resources at the Hacienda housing complex,” Gagan said.
Last year, The Center for Investigative Reporting revealed squalid conditions for the more than 100 seniors and disabled residents of the Hacienda housing complex. For years, residents complained that their persistent struggles with mice, mold and plumbing leaks were ignored by the housing agency. Read More > at Reveal News
From Internet to Obamanet – Critics of President Obama’s “net neutrality” plan call it ObamaCare for the Internet.
That’s unfair to ObamaCare.
Both ObamaCare and “Obamanet” submit huge industries to complex regulations. Their supporters say the new rules had to be passed before anyone could read them. But at least ObamaCare claimed it would solve long-standing problems. Obamanet promises to fix an Internet that isn’t broken.
The permissionless Internet, which allows anyone to introduce a website, app or device without government review, ends this week. On Thursday the three Democrats among the five commissioners on the Federal Communications Commission will vote to regulate the Internet under rules written for monopoly utilities.
…The more than 300 pages of new regulations are secret, but Mr. Wheeler says they will subject the Internet to the key provisions of Title II of the Communications Act of 1934, under which the FCC oversaw Ma Bell.
Title II authorizes the commission to decide what “charges” and “practices” are “just and reasonable”—an enormous amount of discretion. Former FCC Commissioner Robert McDowell has found 290 federal appeals court opinions on this section and more than 1,700 FCC administrative interpretations. Read More > in The Wall Street Journal
Patient, Heal Thyself – Personalized medicine” has become a familiar term that refers to the process of fitting drugs to patient molecular profiles that make it likely that the drugs will perform effectively and safely. Now emerging is literally personal medicine: treatments derived entirely from a patient’s own cells, or almost so, and largely controlled by the nimble and powerful biochemical know-how already embedded in those cells.
Unlike conventional drugs, these cell therapies are created from scratch, one patient at a time, and many of the tools used to create them are simple, compact, and cheap enough to land in laboratories that serve hospitals, small clinics, and doctors in private practice. They have been landing there in growing numbers in the last decade, and Washington has been trying to keep pace. The Food and Drug Administration (FDA) has taken the position—upheld in February 2014 by a federal appellate court—that a patient’s cells become a “drug” when extracted and manipulated in a laboratory, and may not be used to treat the patient without FDA approval. But it is far from clear how the agency should set about approving a custom-made drug that will be prescribed to only one patient, in whom its safety and efficacy will be largely determined by how the patient’s molecular biology interacts with itself.
The widespread interest in human-cell therapies—together with the still-blurry lines between the broad statutory definition of “drugs,” which require FDA approval, and the “practice of medicine,” which does not—has set the stage for an extended and fractious struggle for control, pitting many doctors and patients against Washington. At stake are extremely versatile treatment methodologies that can regenerate damaged tissues and organs and have the potential to cure many currently incurable diseases. Read More > at City Journal