Posts Tagged ‘Europe’

New Orleans king cake, and the French kind

In its traditional presentation, the celebrated Mardi-Gras-season New Orleans King Cake contains a small concealed figurine of a baby which someone gets as part of their slice; the lucky recipient then has to throw the next party or buy the next cake. Back in Feb. 2002 we ran an item, quoting columnist James Lileks, on how purveyors of some store-bought King Cakes no longer were willing to conceal such a figurine, tradition or no. For a discussion of King Cakes, including a picture of what one looks like, check Blawg Review #90, just published the other week at Minor Wisdom.

Now the New York Times introduces us to what is apparently the original French version of the cake, a flat round galette, also served during Carnival and also concealing a good-luck figurine. Don’t expect to encounter this delicacy in American stores, however, for reasons readers of this site will easily anticipate:

Alexandre Colas recalled that he once met a baker from Syracuse, N.Y., at a trade show in Paris, who at first showed interest in buying porcelain favors for his baked goods but later backed off. “He said there were too many legal issues,” he said.

(John Taglibue, “3 Lands of Orient Compete With French Holiday Favors”, New York Times, Jan. 17).

GAO Report: “Science, Business, Regulatory and Intellectual Property Issues Cited as Hampering Drug Development Efforts”

A new report from Congress’s Government Accountability Office — am I the only one who didn’t notice that it changed its name from "General Accounting Office" over two years ago? — attempts to determine why the number of actual applications for approval of new drugs has increased at a much slower rate than the increase in pharmaceutical industry research and development expenditures.

Per the GAO panelists, "conflicting pressures of avoiding risk and producing a high return on investment" combine to curtail the development of the most innovative new drugs:

[C]ompanies prefer to produce drugs that require little risk taking but still offer the potential for high revenues.  This strategy has created an emphasis on producing ‘me too’ drugs — drugs which have a very similar chemical formulation to drugs already on the market.  These drugs are less risky to develop because the safety and efficacy of the drugs on which they are based have already been studied.  According to one panelist, an industry representative, because the length, complexity, and expense of developing a single drug have all increased dramatically over the last 10 to 15 years, companies must choose fewer drugs to develop.  As a result, they will often follow a business model that involves choosing drugs that are easy to develop, with a large market that will produce a large return on investment.

Another factor cited is "sponsors’ uncertainty over how they are to implement requirements for the safety and efficacy of new drugs."  The report notes

general agreement that the lack of precise FDA regulatory standards that outline what constitutes a safe and effective drug is a factor when making drug development decisions — weighing the safety of drugs against their potential therapeutic benefits.  Panelists generally agreed that because there are no precise standards for making these decisions, sponsors and FDA must address them on a case-by-case basis.  As a result, it was indicated that this uncertainty may lead a drug sponsor to abandon a drug rather than risk significant development expenditures.

While product liability litigation is not mentioned in the report by name, it clearly factors in to the industry’s aversion to "risk."  Moreover, at least some of the uncertainty and extra-cautious attitudes within the FDA can be traced to highly publicized — and heavily litigated — withdrawals of drugs based on safety concerns:

* * * Some analysts have reported that safety concerns during the 1990s — which led FDA to request that manufacturers withdraw pharmaceuticals including fenfluramine and dexfenfluramine (known as Fen-Phen) in 1997, Propulsid and Rezulin in 2000, and Baycol in 2001 — impacted FDA’s review requirements.  For example, a 2004 report completed for the European Commission — the executive body of the European Union — found that the withdrawals of these pharmaceuticals from the market affected FDA’s implementation of its regulatory standards.  According to this study, FDA began to demand more complex clinical trials that called for more testing on: (1) how drugs interact with each other, (2) the effect of drugs on liver toxicity, and (3) the relationship of drugs to cardiac risk. In addition, according to several drug development experts and some industry analysts, FDA has been requiring more lengthy and complex clinical trials, which call for more patients and increased costs. . . .

Commenting on the GAO report, Ronald Bailey (Reason Magazine, Hit & Run, "What’s to Blame for Fewer New Pharmaceuticals?," Dec. 20) summarizes:

Why have FDA regulators become more cautious?  Because, as Harvard Business School professor Regina Herzlinger explains in her May, 2006 article, Why Innovation in Health Care is So Hard (not online): ‘Officials know they will be punished by the public and politicians more for underregulating — approving a harmful drug, say — than for tightening the approval process, even if so doing so delays a useful innovation.’

I will venture to suggest that the FDA’s increased obsession with safety may be killing more people than it saves.  How about a GAO study on that question?  After all, if it takes the FDA ten years to approve a drug that saves 20,000 lives per year that means that 200,000 people died in the meantime.

The full GAO report, "New Drug Development: Science, Business, Regulatory and Intellectual Property Issues Cited as Hampering Drug Development Efforts," is available for viewing and download here [PDF].

Yet another Borat suit

This one threatened on behalf of villagers from Glod, Romania, (a stand-in for Kazakhstan in the movie) who say they weren’t paid or given releases for their participation in the film, an assertion denied by the studio. The Los Angeles Times gives a largely sympathetic platform to their lawyer, Ed Fagan, without managing to mention the disciplinary trouble he found himself in (Nov. 26; Aug. 27, 2005 and links therein). Fagan shamelessly admits that he will simultaneously file suits in California, Florida, and Germany; international judge-shopping at its finest. (Bojan Pancevski, “Villagers to sue `Borat'”, Los Angeles Times, Nov. 19).

October 31 roundup

  • A WSJ Law Blog commenter thinks I’m too restrained in criticizing the plaintiffs’ bar. [WSJ Law Blog]
  • The Bush administration just might accomplish something else reform-related in its last two years. [Point of Law; Ideoblog]
  • 12-year-old California boy tries to jump over five-foot-long Halloween decoration that has chicken wire sticking out, hurts himself, 2-1 court decision says he can sue school district for failing to supervise him. [Los Angeles Daily News]
  • Jaycees may be forced to disband over haunted house lawsuit; they’ve stopped running the haunted house already. [Quad City Times]
  • Judge Easterbrook: “Gobs of judicial (and law-firm) time have been squandered by the combination of sloppy drafting, repeated violations of Rule 65(d), and inattention to all sources of subject-matter jurisdiction. If these lawyers were physicians, their patients would be dead.” [Blue Cross and Blue Shield Assoc. v. American Express Co. via Bashman]
  • Britons vandalize speed cameras. [NY Times]
  • Roger Pilon on California Prop 90. [LA Times via Bashman]
  • How to use a condom optimally, and save $13.5 million a year to boot. [Marginal Revolution]
  • You like me! You really, really like me! Or, if not “like,” a small fraction of you tolerate me enough to download my writings off of SSRN. [Torts Prof Blog]

“EU to regulate video blogs?”

A new European Commission proposal would require Web sites and mobile phone services that feature video images to conform to standards set by that body, the Times of London reports. …

Shaun Woodward, the U.K. broadcasting minister, described the draft proposal as catastrophic, saying it could end up forcing someone to get a license to post videos of an amateur rugby team.

(CNet Blogma, Oct. 18). And here’s the Times Online:

Personal websites would have to be licensed as a “television-like service”.

Viviane Reding, the Media Commissioner, argues that the purpose is simply to set minimum standards on areas such as advertising, hate speech and the protection of children.

(Adam Sherwin, “Amateur ‘video bloggers’ under threat from EU broadcast rules”, Times Online, Oct. 17). However, there are some indications that the EU bureaucracy itself intends a less sweeping definition of the law’s application than that: Nate Anderson, ArsTechnica, Oct. 18.

UK: Fugitive spy entitled to damages from gov’t

George Blake, a fugitive from British justice and MI6 double agent who escaped from Wormwood Scrubs prison 40 years ago and fled to Russia, has been awarded £3,350 in damages by the European Court of Human Rights because British authorities delayed too long in resolving a dispute over whether he could collect royalties for his autobiography. Blake, who is now 84 and still on the lam, is believed to have betrayed more than 40 MI6 agents, many of whom were killed, during his career as a double agent. The British government objected to his obtaining royalties on the grounds that he had violated confidentiality by publishing the memoir, but the ECHR accepted the arguments of Blake’s lawyers that it was a violation of his rights for the dispute to have dragged on for nine years in British courts. (Richard Norton Taylor, “MI6 double agent Blake wins damages from government”, The Guardian (UK), Sept. 27; Joshua Rozenberg, “Britain must pay traitor Blake for breaching his human rights”, Daily Telegraph, Sept. 27; Dave Zincavage, Sept. 27).

Great moments in diversity training

“In a strange twist to Britain’s newest terrorism scare, a regional police force admitted Monday that it had sent officers for ‘diversity training’ to an Islamic school that the police searched Sunday as part of a crackdown on jihadist recruiters and trainers. In a statement, the Sussex police said the Jameah Islameah school south of London ‘has been used by officers and staff undergoing advanced training for their role as diversity trainers to the rest of the work force.'” (Alan Cowell, “British School, Searched in Inquiry, Was Used to Train Police”, New York Times, Sept. 5).

Paternalism and Your Money — Part Two

In Part One, I proposed the following heuristic regarding paternalism:

To summarize, although it is not a proper function of government to proscribe “bad” decision making, perhaps a few isolated, objectively defensible carve-outs can be allowed in which the government makes it just a little bit harder to make a bad decision. Perhaps. Stated differently, a paternalist exception that actually proves the libertarian rule should probably be embraced and not shunned.

But does this qualify as such an exception?

In a payday loan transaction, the lender makes a small advance (typically $100-$500) to its customer, agreeing to hold a personal check for the loan amount plus a fee until the customer’s next payday. … The borrower receives cash immediately. Fees charged can range from $15 to $30 on each $100 advanced, although the typical fee is at the lower end of that range.

The fee may seem modest when presented as a dollar amount, but when calculated as an annual percentage rate (APR), the cost is relatively high. A charge of $15 to borrow $100 for 14 days amounts to an APR of 391%. A survey by consumer advocates found APRs on 14-day payday loans ranging from 390% to 871%.

No fewer than five separate bills were introduced in this session of Congress to limit or even ban payday loans. No fewer than four federal financial regulatory agencies, including the Federal Reserve, have launched investigations of the practice. Not to mention the states.

Read On…