TORONTO (Reuters) – Canada‘s main stock index tumbled to a three-month low on Thursday, dragged down by the materials and financial sectors, as soft U.S. and European economic data dampened sentiment.
The Toronto Stock Exchange‘s S&P/TSX composite index <.GSPTSE> was down 143.03 points, or 1.20 percent, at 11,786.76 after the open. Earlier it had fallen to 11,761.34, its lowest since August 7.
(Reporting by John Tilak; Editing by James Dalgleish)
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TORONTO (Reuters) – Interest rate hikes have become less imminent than the Bank of Canada once expected, although rates are still likely to rise, central bank Governor Mark Carney said in an interview published on Saturday.
“Over time, rates are likely to increase somewhat, but over time, so a less imminent timing relative to our expectation,” Carney said in an interview with the National Post newspaper.
Canada’s economy rebounded better than most from the global economic recession, and the Bank of Canada is the only central bank in the Group of Seven leading industrialized nations that is currently hinting at higher interest rates.
But Carney has also made clear that there will be no rate rise for a while, despite high domestic borrowing rates that he sees as a major risk to a still fragile economy.
“We’ve been very clear in terms of lines of defense in addressing financial vulnerabilities,” he said in the interview. “And the most prominent one, obviously, in Canada, is household debt.”
He said the bank was monitoring the impact of four successive government moves to tighten mortgage lending, which aimed to take the froth out of a hot housing market without causing a damaging crash in prices.
A Reuters poll published on Friday showed the majority of 20 forecasters believe the government has done enough to rein in runaway prices, preventing the type of crash that devastated the U.S. market.
The experts expect Canadian housing prices to fall 10 percent over the next several years, but they do not expect the recent property boom to end in a U.S.-style collapse.
(Reporting by Janet Guttsman; Editing by Vicki Allen)
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LONDON (AP) — One teenager made offensive comments about a murdered child on Twitter. Another young man wrote on Facebook that British soldiers should “go to hell.” A third posted a picture of a burning paper poppy, symbol of remembrance of war dead.
All were arrested, two convicted, and one jailed — and they’re not the only ones. In Britain, hundreds of people are prosecuted each year for posts, tweets, texts and emails deemed menacing, indecent, offensive or obscene, and the number is growing as our online lives expand.
Lawyers say the mounting tally shows the problems of a legal system trying to regulate 21st century communications with 20th century laws. Civil libertarians say it is a threat to free speech in an age when the Internet gives everyone the power to be heard around the world.
“Fifty years ago someone would have made a really offensive comment in a public space and it would have been heard by relatively few people,” said Mike Harris of free-speech group Index on Censorship. “Now someone posts a picture of a burning poppy on Facebook and potentially hundreds of thousands of people can see it.
“People take it upon themselves to report this offensive material to police, and suddenly you’ve got the criminalization of offensive speech.”
Figures obtained by The Associated Press through a freedom of information request show a steadily rising tally of prosecutions in Britain for electronic communications — phone calls, emails and social media posts — that are “grossly offensive or of an indecent, obscene or menacing character — from 1,263 in 2009 to 1,843 in 2011. The number of convictions grew from 873 in 2009 to 1,286 last year.
Behind the figures are people — mostly young, many teenagers — who find that a glib online remark can have life-altering consequences.
No one knows this better than Paul Chambers, who in January 2010, worried that snow would stop him catching a flight to visit his girlfriend, tweeted: “Crap! Robin Hood airport is closed. You’ve got a week and a bit to get your (expletive) together otherwise I’m blowing the airport sky high.”
A week later, anti-terrorist police showed up at the office where he worked as a financial supervisor.
Chambers was arrested, questioned for eight hours, charged, tried, convicted and fined. He lost his job, amassed thousands of pounds (dollars) in legal costs and was, he says, “essentially unemployable” because of his criminal record.
But Chambers, now 28, was lucky. His case garnered attention online, generating its own hashtag — (hash)twitterjoketrial — and bringing high-profile Twitter users, including actor and comedian Stephen Fry, to his defense.
In July, two and half years after Chambers’ arrest, the High Court overturned his conviction. Justice Igor Judge said in his judgment that the law should not prevent “satirical or iconoclastic or rude comment, the expression of unpopular or unfashionable opinion about serious or trivial matters, banter or humor, even if distasteful to some or painful to those subjected to it.”
But the cases are coming thick and fast. Last month, 19-year-old Matthew Woods was sentenced to 12 weeks in jail for making offensive tweets about a missing 5-year-old girl, April Jones.
The same month Azhar Ahmed, 20, was sentenced to 240 hours of community service for writing on Facebook that soldiers “should die and go to hell” after six British troops were killed in Afghanistan. Ahmed had quickly deleted the post, which he said was written in anger, but was convicted anyway.
On Sunday — Remembrance Day — a 19-year-old man was arrested in southern England after police received a complaint about a photo on Facebook showing the burning of a paper poppy. He was held for 24 hours before being released on bail and could face charges.
For civil libertarians, this was the most painfully ironic arrest of all. Poppies are traditionally worn to commemorate the sacrifice of those who died for Britain and its freedoms.
“What was the point of winning either World War if, in 2012, someone can be casually arrested by Kent Police for burning a poppy?” tweeted David Allen Green, a lawyer with London firm Preiskel who worked on the Paul Chambers case.
Critics of the existing laws say they are both inadequate and inconsistent.
Many of the charges come under a section of the 2003 Electronic Communications Act, an update of a 1930s statute intended to protect telephone operators from harassment. The law was drafted before Facebook and Twitter were born, and some lawyers say is not suited to policing social media, where users often have little control over who reads their words.
It and related laws were intended to deal with hate mail or menacing phone calls to individuals, but they are being used to prosecute in cases where there seems to be no individual victim — and often no direct threat.
And the Internet is so vast that policing it — even if desirable — is a hit-and-miss affair. For every offensive remark that draws attention, hundreds are ignored. Conversely, comments that people thought were made only to their Facebook friends or Twitter followers can flash around the world.
While the U.S. Supreme Court has ruled that First Amendment protections of freedom of speech apply to the Internet, restrictions on online expression in other Western democracies vary widely.
In Germany, where it is an offense to deny the Holocaust, a neo-Nazi group has had its Twitter account blocked. Twitter has said it also could agree to block content in other countries at the request of their authorities.
There’s no doubt many people in Britain have genuinely felt offended or even threatened by online messages. The Sun tabloid has launched a campaign calling for tougher penalties for online “trolls” who bully people on the Web. But others in a country with a cherished image as a bastion of free speech are sensitive to signs of a clampdown.
In September Britain’s chief prosecutor, Keir Starmer, announced plans to draw up new guidelines for social media prosecutions. Starmer said he recognized that too many prosecutions “will have a chilling effect on free speech.”
“I think the threshold for prosecution has to be high,” he told the BBC.
Starmer is due to publish the new guidelines in the next few weeks. But Chambers — reluctant poster boy of online free speech — is worried nothing will change.
“For a couple of weeks after the appeal, we got word of judges actually quoting the case in similar instances and the charges being dropped,” said Chambers, who today works for his brother’s warehouse company. “We thought, ‘Fantastic! That’s exactly what we fought for.’ But since then we’ve had cases in the opposite direction. So I don’t know if lessons have been learned, really.”
___
Jill Lawless can be reached at http://Twitter.com/JillLawless
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LOS ANGELES (TheWrap.com) – Is it time for Uncle Sam to go Hollywood?
With the exodus of film and TV production to foreign shores – and with the states’ incentives plans frequently out-gunned by countries outside the U.S. – there is some thought that it may be time for the federal government to step in.
The idea of the federal government helping out Hollywood while it is drowning in red ink is sure to raise hackles in some quarters. But filmmaker Michael Moore, for one, thinks it’s an idea whose time has come. And he’s not alone.
“That is one good thing the government can do in terms of being helpful and supportive, whether it’s filmmaking or other artistic endeavors,” Moore told TheWrap.
And he added, it’s also time for the states to stop fighting each other with differing tax-incentive plans. “I’ve always opposed New Mexico against North Carolina, or Michigan against L.A. I don’t like that. It’s not right. We’re Americans.”
Moore is not alone.
There are reasons to keep TV and film production from going abroad. The industry provides more than 2.4 million American jobs and adds nearly $ 180 billion to the U.S. economy annually and $ 15 billion in federal and state taxes, according to the Motion Picture Association of America.
Joe Chianese, executive VP at showbiz payroll giant Entertainment Partners Financial Solutions, believes the idea of getting the feds involved makes sense.
“You watched the debates and heard both President Obama and Gov. Romney talking about how it’s all about jobs, and they talked about how the manufacturing industry has basically been lost to overseas,” Chianese told TheWrap. “Well, we’re looking at the same sort of situation with the TV and film industry if something isn’t done.”
As he spoke to TheWrap, Chianese was about to set off for Japan, where government and film-industry officials were considering an incentive program that would align them with the more than 30 foreign countries trying to lure U.S. entertainment productions.
“You can’t blame filmmakers for taking their business elsewhere,” he said. “They’re taking their work overseas for the same reasons manufacturers are: It’s cheaper.”
Until recently, the federal government provided some help. Section 181 of the current tax code lowered the cost of capital for domestic film and TV production by providing immediate expensing on the first $ 15 million of production costs. To be eligible, 75 percent of the production had to occur in the U.S.
But it expired at the end of 2011.
California Republican Congressmen David Dreier has co-authored legislation to bring 181 back for another two years, but it is mired in Congress, along with a number of other tax-law extensions.
“Jobs are our No. 1 priority, and this bill will help more people find good jobs in California and across the U.S.,” said Dreier, who represents much of the San Gabriel Valley. “We need to create an environment that will keep entertainment productions here so that caterers, makeup artists and other small businesses that support them can create jobs too.”
Amy Lemistch, executive director of the California Film Commission, shares the world view on keeping show business here.
“We see California’s runaway production problem as a global issue,” she told TheWrap “not a state vs. state issue. People are going to the U.K. and Canada as much as they are going to other states.”
Smaller nations like Sri Lanka have begun offering breaks, and others like New Zealand have ramped up state-of-the-art production infrastructures. Even Iceland recently lured the HBO series “Game of Thrones” and the feature films “Noah” and “Prometheus.”
Particularly galling to California Film Commission officials is when productions set in the state are lured overseas. Recent examples would be the now-canceled Fox TV series “Alcratraz” and the L.A.-set movie “This Means War,” both of which shot in Vancouver.
Unlike Moore, Chianese, a tax specialist who worked with the commission when it was crafting its credits program, sees the federal incentives coming on top of state credits, rather than replacing them.
“You add, say, a 15 percent jobs credit, where companies would get 15 percent of the salary of every hire they make,” he said. “Add that on top of, say, the 25 percent credit California offers, and you’re up to 40 percent credit. That would make a real difference when it comes to keeping entertainment jobs here.”
Chianese said he’d be willing to see Section 181 go away in favor of more direct and immediate incentives. But with Obama and Congress focused on cutbacks and new taxes to pare down the national debt before the end of the year, the timing’s not good now.
It will always be an uphill fight, particularly with the House of Representatives controlled by the budget-conscious GOP.
“You’d face the same question you always do with incentives, which is: Why favor one industry over another?” Chianese said.
Not to mention major blowback from the segments of the right, which see liberal politicians as too tied to Hollywood already.
As for state credits, Hollywood breathed a sigh of relief in late September when California Gov. Jerry Brown signed a two-year extension of the state’s film and TV production-tax credit program. But no one expects it to be a game-changer when it comes to California’s fight to remain the world’s production capital.
New York, for example, is offering 30 percent tax credits, has $ 420 million available and recently added a 25 to 30 percent credit for post-production work. By comparison, California offers a 25 percent credit, has just $ 100 million available and has tougher eligibility rules.
Still, Lemisch said, the extension was critical.
“It sends a signal to the production community that California is committed in the short and long term,” she said. That’s vital, she pointed out, especially for the producers of TV dramas, which are the most desirable shows to land because they’re typically an hour long and shoot multiple episodes.
California’s output of TV dramas fell more than 11 percent last year, while While New York was hitting record production levels.
California does have some built-in advantages that aren’t going away. If you’re based in Hollywood, staying here can be cheaper than going out of state even with incentives, because you’re not paying to ship equipment and transport crews. The state’s infrastructure of studios and post-production facilities is still the most extensive.
But that doesn’t mean other states aren’t beating California to the production punch.
North Carolina – which made headlines when it enticed the feature film “Battlefield Los Angeles” to shoot there instead of in L.A. – is very busy these days. The first “Hunger Games” was filmed there, as was “Iron Man 3.’ NBC’s new drama “Revolution” and Showtime’s “Homeland” are in production there now.
Georgia, too, has seen a recent surge in feature filming. Paramount’s “Flight,” Fox’s “Parental Guidance” and Warner Bros.’ “Trouble With the Curve” all shot there.
(Steve Pond contributed to this report)
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(Reuters) – Johnson & Johnson, Merck & Co Inc and Eli Lilly & Co, plan to launch a one-stop database of global clinical trial sites aimed at streamlining paperwork and speeding the process for testing new drugs.
The partners have begun securing approval from as many as 100,000 clinical investigators to enter their details into the database, Andreas Koester, head of clinical trial innovation/external alliances at J&J’s Janssen unit, said in a telephone interview.
“The feedback we have gotten so far is … they can’t wait to get rid of the administrative burden and red tape,” he said.
The initiative was limited to three companies while the kinks are ironed out, but the goal is for additional pharmaceutical companies to join in.
Ten drugmakers – J&J, Lilly, Abbott Laboratories Inc, AstraZeneca Plc, Boehringer Ingelheim, Bristol-Myers Squibb Co, GlaxoSmithKline Plc, Pfizer Inc, Roche Holding AG and Sanofi SA – announced in September the formation of the nonprofit TransCelerate BioPharma with the wider goal of simplifying and standardizing trial practices.
The clinical investigator database will contain key information such as infrastructure details and good clinical practice (GCP) training records.
“GCP doesn’t get any better if the investigator takes it repeatedly,” Koester said. “We wouldn’t have to ask each site – do you have a centrifuge, or do you have a minus 70 degrees freezer?”
J&J estimated that the investigator databank will be operational by the end of the year.
(This story corrects spelling of Lilly in headline and throughout story)
(Reporting By Deena Beasley; Editing by Bob Burgdorfer)
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In October 2003, the Senate Committee on Health, Education, Labor, and Pensions assembled for hearings on compounding pharmacies. These state-licensed retail businesses mix and sell medications, but without the federal safety approval required for mass-produced drugs. Then-Senator Christopher Bond (R-Mo.) convened the hearing by warning of “a significant number of very real problems caused by compounded drugs.” The committee, he said, had “received reports of non-sterile eye drops causing blindness; spinal injections contaminated with bacteria and/or fungus, resulting in hospitalizations and, in some cases, death; and children poisoned as a result of pharmacy compounding errors.” In one case, a pharmacist in Bond’s home state had been convicted in 2002 and sent to prison for diluting more than 4,000 doses of chemotherapy drugs.
Expert witnesses testified that to address such dangers, Congress should give the Food and Drug Administration authority over compounders. Not everyone agreed. Senator Pat Roberts (R-Kan.) commented from the dais that he’d met privately with a physician named Steven Hotze, who was “eager to provide the committee with his input on this important topic.” That input bore the stamp of Hotze’s free-market philosophy. “Regulatory agencies,” he asserted in written testimony, “cannot prevent an individual from committing a criminal act. However, regulatory agencies can, and often do, adversely affect the efficient, safe, and productive practice of business.”
The impresario of a nationally prominent alternative-medicine practice in Houston, Hotze has helped popularize what he calls the Wellness Revolution and what others call the anti-aging movement. With roots in the timeless quest for rejuvenation, the disparate products and treatments associated with anti-aging became a booming business in the mid-1990s. Defined expansively to include everything from dietary supplements such as resveratrol to hormone-replacement capsules and creams, the anti-aging industry generates annual sales of $ 80 billion, according to the research firm Global Industry Analysts.
Photograph by Daniel SheaPharmacist Sarah Sellers quit compounding over inadequate sterilization and other practices. The influence of anti-aging compounders, she says, “has been surprising and not well-understood”
Hotze promotes an eight-step regime emphasizing “bio-identical” estrogen, testosterone, and other plant-derived hormones, which are made and sold at the Hotze Pharmacy, an arm of the 90-employee Hotze Health & Wellness Center, which resembles not a Walgreens (WAG) but a high-end spa in a suburban Houston neighborhood. Suzanne Somers, the former Three’s Company sitcom actress, Thigh Master marketer, and best-selling health-tips author, sings Hotze’s praises. So do patients who appear in his advertising videos or on his four-day-a-week Houston radio show. A conservative activist, Hotze has gone to court and coordinated online campaigns to thwart federal oversight of compounding pharmacies, many of which resemble conventional drug-dispensing stores. He and other anti-aging advocates are a vital subset of the compounding industry. Indeed, compounders continue to operate in a regulatory gray zone, in part because of Hotze and his anti-aging colleagues, according to Sarah Sellers, a pharmacist who has advised the FDA. “Their influence,” she says, “has been surprising and not well-understood.”
Congress didn’t act on compounding after the Senate hearings nine years ago. Legislation surfaced in 2007, but again, it didn’t get far. Now, in the wake of a meningitis outbreak linked to a compound pharmacy in Framingham, Mass., bills are being introduced once more. Eclipsed temporarily by the lethal hurricane in the Northeast and the presidential election, the New England Compounding Center (NECC) scandal has forced the issue. In October, NECC recalled more than 17,000 vials of a back-pain steroid after tainted doses were linked to cases of fungal meningitis. So far, 438 people nationwide have suffered infections, leading in many cases to strokes and to swelling of the membranes covering the brain or spinal column; 32 patients have died.
Neither Hotze nor other anti-aging practitioners are implicated in the meningitis outbreak. Many mainstream physicians and researchers question the efficacy and potential side effects of certain anti-aging treatments, but that’s a separate issue from whether compounding needs better oversight. This is the story of the little-noticed role Hotze and other wellness entrepreneurs play in the compounding industry—and, in particular, how they’ve helped compounders avoid more stringent federal regulation.
Hotze, 62, holds proudly defiant views on many issues, none stronger than his hostility to what he sees as government overreaching. On compounding, he says: “They want to regulate us to death. That’s what we’ve fought against.”
A 1976 graduate of the University of Texas Medical School, Hotze began his career conventionally, as an emergency room physician and then general practitioner. Mainstream medicine, though, left him frustrated. Many patients seemed not to respond to FDA-approved drugs he prescribed. In 1988 he had an awakening. An elderly woman told him: “Ever since I threw away all the medications you gave me, I feel like a million dollars.” He shared this revelation with his wife, Janie. They “knelt before God,” according to his center’s website, “and asked Him to give them a way that they could help their patients get well, and at the same time build a practice that could support their eight children.”
Photograph by Daniel SheaThe Wellness Guru: “They want to regulate us to death. That’s what we’ve fought against”
Their prayers were answered. Hotze became a leading evangelist of alternative treatment aimed at correcting hormonal imbalances rather than “masking” symptoms with what he disparages as “anti drugs”—antibiotics, antihistamines, antidepressants, and so forth. “We are able to help you regain and prolong your quality of life by utilizing bio-identical hormones, vitamins, and minerals, and an optimal eating regime, all of which restore hormones to optimal levels, strengthen the immune system, and increase energy levels,” he promises in promotional literature. “Get back your life” is the slogan at the Hotze center. The nattily attired proprietor refers to his patients as “guests,” adding: “I’m in the hospitality business, and in that context, we provide health care.”
By the early 2000s, enterprising pharmacists all across the country were benefiting from the spreading popularity of anti-aging therapies. A central tenet of this movement is that patients ought to seek natural remedies whenever possible and avoid at all costs what Hotze calls “counterfeit” hormones manufactured under patent by large FDA-regulated corporations. He points to mainstream research showing that these drugs increase the risk of breast cancer and heart attack. He advocates instead unpatented mixtures made by compounding pharmacies—like his. His bio-identicals are formulated from yams and, he says, “fit perfectly into the hormone receptors found in the cells of the body.”
Although compounding may conjure images of cloaked apothecaries hunched over mortar and pestle, the practice was widespread until big manufacturers systematized drug production 60 to 70 years ago. Even after the FDA began regulating the safety of new drugs in 1938, state-chartered pharmacies continued to provide specialty medications that weren’t otherwise commercially available: a syrup with a flavor added to appeal to a sick child, a pill reformulated to remove an allergen, a customized intravenous solution for a cancer sufferer. Viewing compounders as a disappearing breed operating on a small scale, the FDA didn’t require that their one-off mixtures receive federal approval as new drugs.
Meanwhile, the advent of compounded wellness remedies proved a godsend for struggling mom-and-pop pharmacies competing against discount retailers, in part because most chains didn’t bother with hormones, which often aren’t covered by health insurance. In her 2010 book Selling the Fountain of Youth, author and former Businessweek senior writer Arlene Weintraub recounts how pharmacists “could go into a back room, mix up hormones according to a doctor’s instructions, and sell them straight to patients.” By 2003 more than 30 million prescriptions for compounded drugs were being written every year. Today about 3 percent of all prescriptions call for compounded drugs, according to the International Academy of Compounding Pharmacists (IACP), a trade group.
Not all pharmacists were gung-ho about the revival of compounding, which was also spurred by compounders’ ability to provide versions of drugs that large companies ceased to manufacture. As a rookie pharmacist in Florida in the early 1990s, Sellers, the former FDA adviser, observed what she considered inadequate sterilization of compounded spinal injections and a lack of potency testing. She suggested switching exclusively to patented, FDA-approved products. Her employer refused, telling her that doing so would reduce profits. Sellers quit and began doing broader research on sterile compounding. In 1998 the FDA invited her to serve on its Advisory Committee on Pharmacy Compounding. The panel was charged with helping to implement a federal law enacted in 1997 to clarify the rules that applied to compounders.
The FDA had grown concerned that some compounding pharmacies were going beyond the one-patient, one-prescription model to become, essentially, drug manufacturers. The agency took this anxiety to Congress, which, as part of the 1997 FDA Modernization Act, said compounding could remain exempt from federal safety review, but only in its traditional prescription-by-prescription form. If they produced drugs in bulk and not to fill individual patient scripts, pharmacists would be considered manufacturers. In a provision that would prove fateful, Congress sought to deter mass production by prohibiting pharmacists from advertising compounded drugs.
Some doctors and pharmacists viewed the federal action as an intrusion. “We’re regulated as it is,” Hotze says. “We have state regulation that is thorough and sufficient.” David Miller concurs. The chief executive of the IACP, to whose political action committee Hotze contributes, Miller notes that “doctors, nurses, and hospitals are all state-regulated. The FDA’s repeated efforts to oversee us—that is just an attempt to do something without jurisdictional authority. We have made our voice heard in opposition.”
That they did. In 1998, before the Modernization Act had even been enforced, pharmacists in six states (although not Hotze) filed suit in federal court in Nevada claiming their constitutional rights were endangered. When the litigation reached the Supreme Court four years later, the IACP filed a brief pointing out that compounding enjoyed a storied tradition in America: John Winthrop (1606-76), son of the first governor of Massachusetts, was one of the country’s first pharmacists in an era when compounding was the entire game. The ban on ads for compounded drugs, industry lawyers argued, infringed pharmacists’ First Amendment right to free speech. The argument worked. By a 5-4 vote, the justices ruled that preventing large-scale compounding was an insufficient rationale to justify compromising “commercial speech.”
In the years that followed, Hotze and another group of pharmacists stayed on the offensive. In 2004, nine months after he personally lobbied the Senate committee, Hotze was back on Capitol Hill, telling a House subcommittee not to trust federal drug regulators. “The drugs that the FDA approves kill Americans every day,” he said. Later that year he helped organize a group of compounding pharmacists to sue the FDA again, this time in Texas. The suit aimed to settle once and for all whether the agency had authority over the drug mixers. Instead, it added to the muddle.
A federal trial judge initially ruled for the pharmacists, but in 2008 a three-judge appellate panel said the Supreme Court’s decision six years earlier should be read narrowly to allow compounding with a modicum of FDA oversight. The upshot was that the federal agency claimed it still had some authority while compounders insisted it had almost none.
Simultaneously, Hotze spearheaded a lobbying campaign to block a bill introduced in 2007 by the late Senator Edward Kennedy of Massachusetts that would have given the FDA the unmistakable clout to inspect and regulate compounding pharmacists. A Hotze-sponsored online group called Project: FANS (Freedom for Access to Natural Solutions) organized telephone and e-mail campaigns to urge members of Congress to oppose the Kennedy bill. FANS warned that “the bureaucrats at the FDA would determine which pharmaceutical company drug is best for you.”
Compounders know how to mobilize. During the 2007 Compounders on Capitol Hill campaign, the IACP dispatched 404 members to pay in-person visits to 285 congressional offices. Since 2000 the IACP has spent $ 1.1 million on lobbying in Washington, according to the nonpartisan Center for Responsive Politics. That money has purchased the services of such engineers of influence as Parry, Romani, DeConcini & Symms and Arnold & Porter. Never a top priority for either party, the Kennedy bill died. The FDA continued to write the occasional warning letter about compounders whose conduct resembled that of an interstate manufacturer; lacking clear authority, however, the agency mostly stayed on the sidelines.
Hotze’s personal brand is familiar to many Houstonians whether or not they partake of the Wellness Revolution. On one recent morning he arrived at the health center after an appearance on Great Day Houston on the local CBS affiliate, during which he puckishly recommended that middle-aged men seek testosterone replacement therapy to “put a tiger back in your tank.” Clad in a camera-friendly cerulean blazer and paisley pocket square, the doctor hustled to his office, where a film crew from out of town was set to shoot a video for his website. “It’s all about marketing,” Hotze says. “That’s where the leads come from.”
Still life art direction by Morgan Brill
Over the past 15 years, Hotze estimates, the 20,000-square-foot center has served 25,000 guests. Hotze says 20 percent of his patients come from out of state, some because they’ve seen his ads in airline magazines. His elegantly appointed second-floor waiting area resembles a luxury hotel lounge. The mostly female staff of nurses, medical assistants, and telemarketers with headsets wear identical, trimly cut black pantsuits. In the spotless compounding lab, technicians in protective hats, tunics, and booties weigh and mix the powders and creams purchased by guests. The Hotze Pharmacy handles about 450 prescriptions a day. As many insurance companies won’t cover the remedies Hotze prescribes, customers pay out of their own pockets.
The doctor’s interests extend beyond medicine. According to the Houston Chronicle, Hotze has been “a powerhouse” in local Republican primaries. Opposing gay causes and candidates has been one of his main missions, although he hasn’t always been as successful on that score as he has in thwarting federal pharmacy regulation. In a 1990 video titled “Restoring America: How You Can Impact Civil Government,” Hotze told viewers: “There is no neutrality. Civil government will either reflect biblical Christianity, or it will reflect anti-Christian positions. You can make the difference.”
Hotze merged several of his concerns into a campaign in 2010 against President Barack Obama’s health overhaul bill. The FANS website urged citizens to lobby members of Congress to kill the legislation. “Do we want to kiss goodbye to medical innovation, like possible cures for cancer and other life-saving medical treatments?” FANS asked. “Keep the government out of medical care and let the free market work its magic.”
The NECC scandal—which, to repeat, did not involve Hotze or anti-aging therapies—has restarted the debate about whether state-level regulation is sufficient to ensure the safety of compounded drugs, or if it’s time to reconsider the type of oversight Hotze and the IACP have frustrated so far. (“What went on up there in Massachusetts, I can’t say,” Hotze notes. “I don’t know the facts.”)
In an Oct. 29 survey of pharmacy board records from all 50 states, the office of Representative Edward Markey (D-Mass.) concluded that the agencies “do not, as a general rule, appear to undertake enforcement actions that relate to the safety or scope of compounding pharmacy practices.” Rather, the states “focus more on compliance with traditional pharmacy licensing, controlled substances, and other requirements.” Massachusetts health officials have fired the director of the state’s pharmacy board for failing to investigate a complaint about NECC. Markey, in whose district NECC operated until October, has introduced a bill that would authorize the FDA to inspect and oversee compounding pharmacies.
In addition to the recent meningitis outbreak, Markey’s staff has found records documenting 23 deaths and at least 86 serious illnesses or injuries since 2001 associated with improper compounding practices. “These totals should be considered to be conservative,” the staff concluded, “since in many cases the reviewed documents noted the existence of adverse events but did not specify the type or quantity.”
Hotze and IACP note the FDA had a chance to crack down on NECC and missed it. Because of hints that the business was compounding on a large scale, the federal agency inspected NECC and in 2006 issued a warning letter. “The FDA suspected this was a drug manufacturer, not a legitimate compounding pharmacy, and they had jurisdiction to close down a drug manufacturer but did not,” Miller of the IACP says. “It seems facile,” he adds, to propose giving the FDA more power when the agency already has the ability to shut rogue drug factories. “It’s a frustration for our profession,” Miller says, “that the FDA seems intent on insinuating itself into the day-to-day practice of pharmacy.”
The FDA wants Congress to expand and clarify its authority. In anticipation of a new round of Capitol hearings on Nov. 14 and 15, the agency issued a statement asking lawmakers to strengthen federal oversight. FDA Commissioner Margaret Hamburg was scheduled to testify before separate House and Senate committees. While lawmakers debate the future of compounding, Hotze himself was back in Washington to monitor the hearings and meet privately with several members of Congress. “The last thing we need,” he says, referring to the NECC case, “is for Washington to overreact to one bad actor.”
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SAN FRANCISCO (Reuters) – Shares of Facebook Inc jumped 10 percent in early trading on Wednesday, even as the biggest block of shares held by insiders became eligible for sale for the first time since the social media company’s disappointing debut in May.
In heavy morning trading, Facebook gained $ 2.02 to $ 21.89.
“While the lock-up is expiring, there is nothing requiring anybody to sell,” said Tim Ghriskey, chief investment officer at Solaris Group in Bedford Hills, New York. “Given the low price, these long-term holders are deciding to hold the stock and that is lifting it here as the fear of the expiration subsides.”
Roughly 800 million Facebook shares could begin trading on Wednesday after restrictions on insider selling were lifted on the biggest block of shares since the May initial public offering.
The lock-up expiration greatly expanded the 921 million-share “float” available for trading on the market until now.
Facebook, the world’s No. 1 online social network, became the only U.S. company to debut with a market value of more than $ 100 billion. But its value has dropped nearly 50 percent since the IPO on concerns about its long-term money-making prospects.
Insider trading lock-up provisions started to expire in August, and the rolling expirations have added to the pressure on Facebook’s stock.
Pivotal Research Group analyst Brian Wieser said he didn’t expect Facebook insiders to sell all of their shares as the lock-ups expired.
“I would expect heavy volumes over the next few weeks, but not undigestible volumes,” said Wieser. By his estimates, roughly 486 million of the nearly 800 million newly freed Facebook shares will be sold.
There is some evidence that the heavy interest in shorting the stock was dissipating, given the poor performance since it first sold shares in May.
According to Markit’s Data Explorers, about 28 percent of the shares available for short-selling were being borrowed for that purpose, down from a high of more than 80 percent in early August.
Similarly, SunGard’s Astec Analytics, which also tracks interest in shorting, noted in a comment on Tuesday that the cost of borrowing Facebook shares is down more than 50 percent since the beginning of the month.
“Everything would seem to indicate the market is losing its appetite to short Facebook,” wrote Karl Loomes, market analyst at Astec.
Several members of Facebook’s senior management have sold millions of dollars worth of shares in recent weeks through pre-arranged stock trading plans as lock-up restrictions expired.
Chief Operating Officer Sheryl Sandberg has sold roughly 530 million shares this month, netting just over $ 11 million, though she still owns roughly 20 million vested shares in Facebook.
In August, Facebook board member Peter Thiel sold roughly $ 400 million worth of Facebook stock, the majority of his stake, when an earlier phase of lock-up restrictions expired.
Facebook’s 28-year-old chief executive, Mark Zuckerberg, has committed to not sell any shares before September 2013.
(Reporting by Alexei Oreskovic; Editing by Jeffrey Benkoe)
Internet News Headlines – Yahoo! News
NEW YORK (Reuters) – Actor Channing Tatum, who set female hearts fluttering in the summer movie hit “Magic Mike”, was named the sexiest man alive by People magazine on Wednesday.
“My first thought was, ‘Y’all are messing with me,” Tatum told the magazine after hearing the news.
The 32-year-old actor, who is married to actress Jenna Dewan-Tatum, is training to play an Olympic athlete in his upcoming film, “Foxcatcher”.
The couple, who have been married since 2009, are ready to start a family, according to People.
“The first number that pops into my head is three, but I just want one to be healthy and then we’ll see where we go after that,” he told the magazine.
Tatum joins a long list of Hollywood heartthrobs who also have also received the “sexiest man” title from the magazine including Brad Pitt, Johnny Depp, Ryan Reynolds, George Clooney and Matt Damon.
(Reporting by Patricia Reaney; Editing by Maureen Bavdek)
Celebrity News Headlines – Yahoo! News
Pamela Costa has never known a day without agonizing pain in her legs and feet.
At age 11, the Seattle native was diagnosed with inherited erythromelalgia, a genetic condition that causes such severe pain and redness some call it “Man on Fire Syndrome.”
“Think of the feeling that you get when you come in from the cold and your hands and feet are rewarming too fast,” said Costa, 47. “I have that feeling all of the time.”
Inherited erythromelalgia is a disease of small nerves and blood vessels that causes severe pain in response to heat, pressure, exertion or stress.
“These people feel excruciating, scalding pain while putting on shoes or putting on a sweater,” said Dr. Stephen Waxman, a neuroscientist at Yale University and the West Haven Veterans Affairs Hospital. “They will keep their feet on ice to the point of getting gangrene, just to relieve the sensation.”
When Costa was growing up, playing outside would trigger the unbearable burning sensation.
“I used to come in from recess and just hold my hands on the cool metal of my school desk,” said Costa, who has more than two dozen relatives with the same affliction. “I have had cousins suffer devastating injuries from over-cooling themselves.”
Although the disease is rare, researchers are searching for clues to its cause with hopes of uncovering treatments for chronic pain of all kinds. The story starts at the molecular level within tiny nerves that conduct pain signals.
An Overactive Channel Protein
Pain comes in different forms, depending on the type of nerve that senses it. And for chronic pain patients, the pain is not quick and specific, but instead slow and sharp.
This slow pain is transmitted from the limbs and body to the brain along small nerves in the spinal cord called C-fibers. Messages move along these nerve fibers due to the action of special proteins in their membranes called channels. One specific type of channel is the Nav1.7 sodium channel, which is present in great numbers in the C-fibers of the spinal cord.
Work by Waxman and others has shown that patients with inherited erythromelalgia have a defect in their Nav1.7 channels that allows too many sodium ions to enter the C-fibers, causing an increase in the sensitivity of the nerves.
The specific atomic structure of the Nav1.7 channel has been modeled by Waxman’s lab, and the results are detailed in the current issue of Nature Communications. Armed with this new model of the Nav1.7 channel, the lab has been able to show why some patients with inherited erythromelalgia respond well to an anti-epileptic drug called Carbamazepine.
Furthermore, in studying the channel structure in many different people, Waxman and colleagues have found variations in the channel from person to person. These variations may cause some people to be more likely to experience chronic pain than others.
A New Drug Target
Patients with a completely defective Nav1.7 suffer from the opposite condition, known as congenital indifference to pain. These people do not experience pain at all, with case reports of being able to walk on hot coals without pain.
As the role of Nav1.7 in the mechanism for pain sensation becomes clearer, biotechnology and pharmaceutical companies will likely take notice, according to Waxman.
“I anticipate a race to develop Nav1.7 specific blockers,” he said.
Current drug therapies for pain include medicines like morphine, as well as aspirin and ibuprofen. While all of these decrease the sensation of pain, they also interact with other tissues such as the brain, heart and stomach, causing side effects.
Nav1.7 does not appear to be present in large quantities outside of the C-fibers of the spinal cord. As such, new drugs targeting this protein could herald a new class of pain treatments with many fewer side effects than our current drugs for pain.
Costa said she hopes to see a day where such a medicine would be available to her, providing her with full relief for the first time in her life.
Also Read
Medications/Drugs News Headlines – Yahoo! News
13 November 2012 Last updated at 06:29 ET
Phil Gooding, Office for National Statistics: “There are two main drivers behind the event, that comes from education and food”
The UK’s inflation rate rose sharply last month following an increase in tuition fees and food prices.
The Office for National Statistics (ONS) said the rate of Consumer Prices Index (CPI) inflation rose to 2.7% in October, up from 2.2% the month before.
The ONS said education costs rose by 19.1% last month after the government lifted the cap on university fees.
Food prices, especially vegetables, also rose after record wet weather earlier this year affected crop yields.
Confectionery prices also increased. The ONS said this was because a number of confectionery products had been reduced in size.
It said it treated this as a price increase in the inflation measures, as consumers were getting less for their money.
The Retail Prices Index (RPI) measure of inflation – which includes housing costs – rose to 3.2% from 2.6%.
The Treasury said the figures were “disappointing”.
Labour’s Shadow Treasury minister, Catherine McKinnell, said the increase was “worrying”.
When the Bank of England decided last week not to create more money to support the recovery, some of us wondered why they didn’t offer an explanation”
End Quote
The ONS also announced it would be introducing a new way of measuring inflation next March, the CPIH, which will include housing costs, something that is not reflected significantly in the currently favoured measure.
Energy prices
September’s CPI inflation rate was the lowest for almost three years, and was significant as it is the month on which rises in many benefits is based.
However, inflation had been expected to pick up from that point, partly because of a recently announced round of energy price rises that are expected to affect inflation figures in the coming months.
The ONS said SSE’s price rise of about 9%, which came into effect last month, was not included in the October inflation figures.
Ross Walker, UK economist at RBS, said the latest figures were slightly worse than predicted.
“They are a little bit disappointing, higher than expected, above the range,” he said. “Ironically, we had the tuition fee increases that are roughly what we expected and the surprise for us was the extent of the food price increase.”
The cap on charges for tuition fees was raised by the government from £3,375 to £9,000 a year.
The Bank of England is charged with keeping inflation close to 2%, something it has struggled to do in recent years, as the standard way of suppressing prices is to raise interest rates, which it does not want to risk during this period of weak economic activity.
Alan Clarke, economist at Scotia Bank, said that target remained elusive: “Where do we go from here? Onwards and upwards. Utility bill increases are on their way. We’ve also got the effect of the US drought and increased food prices to factor in.
“I don’t think we’re going to get anything like the 2% inflation target.”
The Bank of England’s quarterly inflation report will be published on Wednesday.
The rise in inflation may make it less likely that the Bank will provide further stimulus to the economy in the form of quantitative easing.
BBC News – Business
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