Showing posts with label Regulation. Show all posts
Showing posts with label Regulation. Show all posts

Sunday, November 18, 2012

Will we ever… have safe cigarettes?


Will we ever… have safe cigarettes?

Will we ever… have safe cigarettes?
(Copyright: Getty Images)
For decades the tobacco industry has tried to come up with alternatives that people would want to smoke, but this is much harder than you would think. 

There’s an old saying among people who work in public health: Tobacco is the only legal product that, when used as intended, will kill you. Decades of research have thoroughly documented the health problems that result from inhaling tobacco smoke – more than a dozen different types of cancer, heart disease, stroke, emphysema and other respiratory diseases, among others. Are these risks an inevitable part of smoking? Or is there a way of creating safe cigarettes without any of these hazards?
“I think it’s very unlikely,” says Stephen Hecht from the University of Minnesota Cancer Center, who studies tobacco carcinogens – substances that cause cancer. Tobacco smoke is a complex cocktail of at least 4,000 chemicals including at least 70 known carcinogens. No one has made a “cigarette that is significantly decreased in all of these [chemicals] and is still something people would want to smoke, even though the industry has worked on this for around 50 years,” says Hecht. “There’s no indication that it’s possible.”
As Hecht says, it’s not that the industry hasn’t tried. Journalist Will Storr recently documented a history of bungled attempts to create a safer cigarette, from one that passed the carcinogenic smoke through a filter made of another carcinogen – asbestos – to another that heated tobacco rather than burning it, but tasted of sulphur, charcoal, and burning plastic.
The problem is that no single step in the production or consumption process fills cigarette smoke with its dangerous constituents. Some constituents are in the tobacco leaves themselves at the point of harvesting. The plants can absorb metals and metalloids like arsenic and cadmium from fertilisers and the surrounding soil, while sticky hairs on their leaves can gather particles from the air, including radioactive elements like polonium-210.
When the harvested leaves are cured and dried, compounds within them are converted into tobacco-specific nitrosamines (TSNAs), a class of well-known and intensely studied carcinogens. And when the smoker lights up, chemical reactions in the burning leaves fill the smoke with carbon monoxide, hydrogen cyanide and a cocktail of carcinogens – the infamous polycyclic aromatic hydrocarbons (PAHs), and vapour-borne “volatiles” like formaldehyde and benzene. As long as you’re burning plant matter and inhaling the smoke, you’ll get a lungful of carcinogens. “There’s no getting around that fact,” says Neal Benowitz, a pharmacologist from the University of California, San Francisco.
Potent drug
As always with toxicology, it’s the dose that makes the poison, and a laundry list of ingredients is a poor way of assessing a product’s true risk. But it’s clear that many of the substances in cigarette smoke, particularly the well-studied TSNAs, PAHs and volatiles, are found at significant levels in both the smoke and the bodies of smokers who inhale it. And, they cause similar patterns of DNA damage to those seen in actual tumours.
The route of exposure also matters. Many of the chemicals in tobacco smoke are also found in other everyday sources, including foods. But there’s a big difference between taking these substances into your guts, where they pass through a soup of enzymes before being actively transported into the bloodstream, and sucking them directly into your lungs where they can passively diffuse into your blood.
There are some measures that could individually reduce the number of carcinogens in smoke: modifying the blend of tobacco; refining the curing process; including charcoal filters to absorb some of the volatiles; and so on. “But there’s no evidence that this does any good,” says Hecht. None of these measures completely deletes the full spectrum of carcinogens, and Hecht adds, “We tend to focus on the compounds that we know are dangerous, but that’s maybe only a few hundred of the 4,000 that are identified. There could be other things going on that we’re not aware of.”


And then there’s nicotine. This highly addictive drug isn’t a carcinogen, but it’s not entirely benign either. It increases heart rate, constricts blood vessels, and contributes to high levels of cholesterol. There’s some evidence that it could stop cancerous cells from self-destructing or promote the growth of blood vessels that bring oxygen and nutrients to tumours. But both of these claims come from studies in lab-grown cells. “It’s not clear if any of this works in a live animal,” says Hecht. “The big thing [about nicotine] is the addiction.” Nicotine is a potent drug – it’s the one chemical that keeps smokers inhaling all the rest.
Nicotine’s addictive properties have led to some spectacular backfires in attempts to create safer cigarettes. From the 60s and 70s, the tobacco industry marketed “low-tar” cigarettes as safer versions of their normal cousins. These so-called “mild”, “smooth” and “light” alternatives contained tiny vents in their filters, which were meant to allow fresh air to dilute the tar – the collective term for the chemical gunge in smoke.
These cigarettes were tested with machines that, sure enough, measured a lower concentration of tar in the ensuing smoke. But, surprise, people aren’t machines. As the smoke from these brands also contained less nicotine, smokers would get their fix by taking longer drags, smoking more frequently, or simply blocking the filters with their fingers. They ended up inhaling more smoke, and despite the industry’s claims, exposed themselves to the same level of carcinogens.
Safer options?
Smokeless tobacco products fare little better. Even though they are sucked, chewed and sniffed, and never set on fire, they still contain many of the same carcinogens as cigarettes, and have been linked to mouth, oesophageal and pancreatic cancers. The one possible exception is snus, a Swedish product that’s not unlike a “tobacco-stuffed teabag” that you stick under your lips. It’s manufactured according to rigorous standards that limit the amount of nitrosamines in the final product, while still retaining that craving-satisfying nicotine. Snus is billed as the reason for Sweden’s low rates of lung and oral cancers, compared to countries where cigarettes are the dominant tobacco product.
“It’s much safer [than smoked products] but not entirely safe, and there’s a possibility that it still poses a cancer risk,” says Benowitz. Indeed, some recent studies have suggested that snus users have a higher risk of pancreatic cancer, and a higher risk of dying from cancer. “If you simplistically said everyone stopped smoking and used snus, there’d be a tremendous health benefit, but the question is whether they would do that,” says Benowitz. His concerns are that snus could make it harder for active smokers to give up their habit by fuelling nicotine addiction, or act as a gateway drug that entices non-smokers to start. “It’s probably better than smoking, but you probably don’t want to put it in your mouth,” says Hecht.
The same arguments apply to e-cigarettes – battery-powered devices that look like cigarettes, and release a nicotine vapour without any of the accompanying carcinogens. At least, that’s the theory – there’s scant data on what they actually release, and how that varies from brand to brand. An analysis from the US Food and Drug Administration showed that some still contained detectable traces of nitrosamines. “In theory, they could be safer than snus,” says Benowitz. “But there’s been hesitation around them because they are unregulated, so who knows what you’re getting.”
The use of both snus and e-cigarettes will probably remain highly controversial, even after more data comes in. This reflects a tension in public health circles: given smoking is so addictive and damaging, is it acceptable or even ethical to reduce that harm by advocating products that are safer, but still not safe? “If we’d never heard of cigarettes, we’d look at a smokeless tobacco product and say, ‘This thing should be banned’,” says Hecht. In a world where tobacco never existed, these arguments would be moot. But that world does not exist; what do we do in this one?

Source

Thursday, February 23, 2012

10 radical solutions to binge drinking

10 radical solutions to binge drinking

Man drinks wine while cooking

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Pressure to address the UK's binge drinking grows ever stronger, with a number of radical solutions being put forward to try to help people cut down.

David Cameron last week called binge drinking a "scandal" that costs the NHS £2.7bn a year. He pledged to introduce drunk tanks and booze buses, and there are plans for a minimum price for alcohol.

So what are the most radical solutions to the problem?

Subtly make drinks weaker

Definition of binge drinking

  • For men, more than eight units of alcohol - or about three pints of strong beer
  • For women, more than six units of alcohol, equivalent to three small (175ml) glasses of wine

Food firms have recently moved to cut the amount of salt and saturated fat in their products, following government pressure. The British Medical Association wants to see the same thing happen in relation to beer. So, for example, a premium lager could gradually be reduced from 5.5% to 5%, while a bitter comes down from 4.5% to 4%.

But Roger Protz, editor of the Good Beer Guide, says beer in Britain is much weaker than in the rest of Europe. And to reduce it would affect its characteristic flavour. "London Pride [bitter] at 4.1% is a lovely malty, hoppy beer but if you reduce it to 3.5% it will be very different."

Another approach would be to use the tax system to target stronger drinks. The March 2011 budget saw a rise in the duty on strong beers (above 7.5% alcohol) of 25%, and the duty on weak beers (below 2.8%) cut by 50%. Alcohol Concern says this should be extended to wine, which is getting stronger.

The British Beer and Pub Association says the current focus on beer is wrong. "We should be encouraging people to drink more beer rather than stronger drinks, which have been gaining market share. Beer tax here is 12 times that of Germany."

Enforce a minimum price for alcohol

Man carrying recycling box full of empty wine and beer bottles Many find it cheaper to drink at home

A review of international research published last year by Bangor University found that pricing was the "key determinant" for how much people drank.

Alcohol Concern wants to see a minimum rate of 50p per unit of alcohol brought in. It would make a pint of beer at least £1.25 and a bottle of wine £5.

It would hit the low-cost retailers rather than bars and restaurants, says Andrew Misell, a spokesman for Alcohol Concern. "It won't affect pub prices. Where you will be hit hard is in the supermarkets where cider is on sale for as little as 13p a unit."

The drinks industry says such moves only encourage counterfeit and smuggled alcohol. And Tim Martin, founder of JD Wetherspoon, says consumers will simply go abroad. "It's an international industry. People can go to Calais and load up their car with as much alcohol as they want."

Jamie Bartlett, author of Under the Influence, a 2011 report on binge drinking for think tank Demos, says it would cut total alcohol consumption but not necessarily binges. "The problem is people going on benders and it's not clear it would have an impact on that."

Get people back into pubs

Barbara Windsor in a pub, 1963 Pubs are dying out but are they a safer place to drink?

One of the traditional roles of the pub landlord is to tell a drinker when they've had enough. No such authority figure exists in people's living rooms. And pubs are closing in great numbers across the country, as supermarket-bought booze now accounts for about half of what's being consumed.

So, one solution is to shift drinking back into the pub where it is typically more expensive, served in measurable quantities, and supervised by trained staff. Martin says this can be done by cutting VAT on food and alcohol in pubs to 5%, a proposal that has been successful in helping restaurants in France and Ireland. Supermarkets add no VAT on to the food they sell, whereas pubs have VAT of 20%. "Supermarkets are effectively cross subsidising alcohol sales with their food sales. It's a huge tax advantage that undermines pubs," Martin says.

The British Medical Association does not accept that pubs should be cheaper but agrees that shop-bought drink should be made more expensive - "thus encouraging alcohol to be consumed in pubs where there are more controls". Misell cautions against getting too nostalgic about a golden age of pub sobriety that never was. "Some people idolise the pub as this place where it's impossible to get drunk. And yet we all know it's perfectly possible to over-indulge there."

Raise the legal drinking age

Empties in a park

In the US, the legal drinking age is 21. And there's an argument that by raising the minimum age, it makes it easier for retailers to police under-age drinking - most 21-year-olds look like adults. While raising the minimum age is not official BMA policy, the doctors' body argues that it is something that could be explored. A spokeswoman suggests: "Evidence from America clearly demonstrates that raising the legal drinking age has a significant positive effect on alcohol-related problems." Alcohol Concern agrees but says it would be politically impossible to raise the drinking age.

Tim Martin says that teenagers are going to try to drink, regardless of the law. The key thing is that they start by drinking beer in pubs, under the "watchful eye" of the landlord rather than vodka somewhere else. It's time the government stopped trying to entrap landlords by hiring 15 and 16-year-olds to try to get served.

Off-licences are rarely prosecuted for selling to under 18s, as it is, says Bartlett. So to raise the age limit even higher would not make sense. "Last year I think only one off-licence was fined for selling alcohol to a minor," says Bartlett.

The drinks industry says the issue of under-age drinking is already taken seriously in shops. For instance, under the Challenge 25 scheme shoppers are warned that if they look under 25 they may have to show ID, says Richard Dodd, spokesman for the British Retail Consortium. It raises the question of why this is not rolled out everywhere, as happens in countries like Sweden.

Nationalise off-licences

In some places - most of Canada, certain US States and Sweden - only certain state-owned shops can sell alcohol. The most rigorous is Sweden.

To buy a bottle of wine in Sweden, it's necessary to visit one of the country's network of Systembolaget shops, which close on Saturday afternoons and do not open on Sundays. The approach prevents impulse buys in the supermarket and the products are displayed in an atmosphere more akin to a chemist's than an off-licence. The Swedish model is based on the idea that by keeping control of price and availability, alcohol consumption is reduced.

A study carried out by international alcohol researchers in 2010 concluded that scrapping Sweden's state shops would lead to a 14% rise if sales were limited to private liquor stores. And allowing any grocery store to sell alcohol would result in a 29% rise in alcohol consumption.

However, such a proposal is unlikely to go down well with voters. Even Alcohol Concern warns of the dangers of "stockpiling".

And Dodd says it is absurd to crack down on supermarkets which would be most influenced by the change. "Supermarkets are already the most responsible alcohol outlets that there are and I can't see that preventing them from selling alcohol would improve things."

Discourage rounds

Buying rounds can create a social pressure to keep buying drinks because it's your turn. Last year the Sun reported that Prof Richard Thaler, an adviser to David Cameron on "nudge" - a form of behavioural economics, said buying rounds makes people drink more. He recommended that large groups set up a tab to be split at the end of an evening's drinking.

However bizarre, the idea of forbidding rounds is not new. During World War I, buying rounds - "treating" as it was known - was banned after fears that the war effort was being damaged by drunkenness.

Misell says it would be impractical to institute such a ban. But he supports the idea of improving public awareness on the perils of rounds. "My experience of rounds on a night out is that you very easily drink more than intended. My one piece of advice is - don't drink in rounds."

Ban alcohol marketing

Critics of the drinks industry say that cut price deals and cheeky advertising makes people drink more than they otherwise would.

Research in 2008 by the Royal College of Physicians found a link between sports sponsorship by alcohol firms and binge drinking. At the time half of all Premier League football teams and all 12 of the Guinness Premier League rugby clubs had alcohol firms as a sponsor. Today, Everton has a brewer - Chang - as its shirt sponsor and, until recently, Liverpool shirts carried the name of Carlsberg.

Alcohol Concern wants to see alcohol advertising banned from sport, television, and in cinemas for films aimed at those under 18. In theory, advertising is forbidden from associating alcohol with social or sexual success.

Official advice on drinking

  • Introduced in 1987, updated in 1995
  • Men: 21 units a week max, with no more than three or four units a day
  • Women: 14 units a week max, with no more than two or three units a day
  • After heavy drinking, no alcohol for 48 hours to allow body to recover

"But in practice few ads don't include those two things," says Misell. By way of example he points to the beer advert featuring Holly Valance flirting with two Australian comedians. He is also in favour of renaming the large glass of wine (250ml) extra large - it equals a third of a bottle of wine. The small (175ml) glass could then be renamed medium, with a new small size(125ml) available.

Alcohol promotions such as three bottles of wine for £10, or trays of beer tied into the World Cup, are still common in England. However they've been banned in Scotland. Financial Times wine critic Jancis Robinson says banning such deals makes sense. "Cut price wine deals are killing wine suppliers, too."

But Sarah Hanratty, a spokeswoman for the Portman Group, which represents the drinks industry, says banning sports sponsorship and other forms of marketing would punish the sensible majority. "It's a competitive market and the role of marketing is to help consumers choose between brands based on their lifestyle."

Target middle-class professionals

Much of the media attention to do with binge drinking is focused on public drunkenness. But it's arguable that the greater problem is the health impact of drinking too much.

Liver disease is the only major cause of death in Britain that is on the increase. Hospital admissions for alcoholic liver disease among people in their early 30s in north-east England have increased by more than 400% in the past eight years.

“Start Quote

I was at the outer limit - stiff whisky or G&T before dinner, couple of glasses of wine or even half a bottle with it”

Tony Blair on his drinking habits in office

Alastair Campbell, Tony Blair's former spokesman, has recently pointed out that middle-class professionals are now the most frequent drinkers in the country. According to the Office for National Statistics 41% of professional men drink more than their daily limit at least once a week. But instead of targeting the Rioja-drinking classes, the focus of much rhetoric was on the damage done by public drunkenness. For many commentators, the government is pointing at the wrong group.

Nicholas Lezard wrote in the Guardian that Cameron is "trying to make us think of the proletariat getting smashed on cut-price lager". Rod Liddle in the Sunday Times agrees. "He [Cameron] doesn't mean someone who has spent the evening with a really nice Sancerre". He means the poor but "the poor, do not, on the whole, binge drink".

But is it really feasible to target the middle-class professional with their trusty gin and tonic or bottle of pinot noir? Jancis Robinson says it's all unworkable. "I really can't see how the government can effectively control what we drink in our own homes."

Not in front of the children

Child joining in a family toast When - and how - to introduce a child to alcohol?

Parents who drink a lot in front of their children may normalise the idea of heavy drinking. The Demos report, Under the Influence, argued that the government should consider issuing advice to parents about drinking in front of their children.

"This evidence, although limited, fits with what we know about behaviour - that steady exposure to norms and habits tacitly builds attitudes. Therefore more consideration needs to be given to advice that is given to parents about drinking in front of children."

Carrie Longton, co-founder of Mumsnet, says parents need to be aware how they're seen by the children. "You need to teach by example. What you drink is important." So careful about drinking that second glass of wine in front of the children.

Frank Furedi, author of Paranoid Parenting, agrees that parents have an important role to play. But far from avoiding alcohol in front of the kids, parents should allow teenagers to drink a little with a meal.

It removes the mystique of "an illegal drug" and makes it part of food culture, he argues. His view goes against official advice. In 2009, Sir Liam Donaldson, England's chief medical officer at the time, said that children aged under 15 should never drink alcohol.

Stop exaggerating the problem

Traditional social lubricant

The British believe alcohol is a disinhibitor, that it makes people amorous or aggressive.

But it is possible to change our drinking culture. Cultural shifts happen all the time, and there is extensive evidence to show it doesn't take much to effect dramatic changes in how people behave when they drink.

These show that even when people are very drunk, if they are given an incentive - either financial reward or social approval - they are perfectly capable of remaining in complete control of their behaviour.

Read the full article by Kate Fox from October 2011

Figures from 2006 show that the UK was not even among the top 10 per capita alcohol consumers in Europe. And alcohol consumption has been falling here for the past decade. Beer consumption has been declining for decades. And last year for the first time, wine sales fell. Even the worry about youth drinking may be overdone. 2010 NHS statistics showed that 55% of 11 to 15-year-olds have never drunk alcohol, an increase on previous years. Longton says these figures should give parents the confidence to be firm: "My children will say 'mummy everyone's doing it' but the statistics don't bear that out."

Bartlett says that exaggerating the problem can have negative effects. It leads to false "social norming" - people thinking that everyone else is binge drinking so why shouldn't they. "One reason university students go on a bender is because they overestimate the amount all their peers are drinking." But publishing the facts can challenge this. Some student unions have begun putting up posters giving the real drinking statistics for students, which are on average often far lower than expected. Once the true figure is displayed, students tailor their drinking accordingly. In other words, it doesn't do any good to hype up the problem.

Misell accepts that the UK is by no means at the top of the drinking league. But he argues that people are still drinking too much. "There's a big gap between the perception and reality of light drinking. For many it's three or four pints. But the advice from the Chief Medical officer is 3-4 units a day for a man and 2-3 for a woman. In some cases two pints would put you over the recommended limit."

Source

New York police 'spied on' New Jersey Muslims

New York police 'spied on' New Jersey Muslims

NYPD Police Commissioner  Ray Kelly speaks at a press conference 3 February 2012
New York's police commissioner has come under fire for appearing in a documentary about Muslims

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New York City police secretly collected information on Muslim communities in nearby Newark, New Jersey, police records have shown.

Newark Mayor Cory Booker said he was not informed of the surveillance, revealed by the Associated Press.

"This raises a number of concerns," Mr Booker said, promising to investigate. "It's just very, very sobering."

Earlier this week university officials in the US north-east protested against NYPD monitoring of Muslim students.

Administrators at Yale and Columbia protested about the police department's activities, which the NYPD said were justified in an effort to identify possible campus radicalisation.

Earlier this month, civic groups from around the US called for a legal investigation into intelligence-gathering on Shia Muslims in New York.

NYPD's demographic unit compiled information on mosques and Muslim-owned businesses in Newark in 2007, AP reported.

The secret police report obtained by the news agency mentions no evidence of terrorism or criminal behaviour.

"These locations provide the maximum ability to assess the general opinions and general activity of these communities," the report said.

Similar reports were prepared for two counties in Long Island, in New York state.

Jersey unsure

In a statement, the NYPD told the BBC that they had informed Newark officials of their operations.

Newark's former police director, Garry McCarthy, told the Associated Press that the NYPD had contacted his police department "as a courtesy" before sending the officers.

“Start Quote

The police department goes where there are allegations. Remind yourself when you turn out the light tonight”

No Newark police officers were involved in the surveillance, according to Mr McCarthy.

But New Jersey Governor Chris Christie said he had knowledge of the operation, which he called "disturbing".

Newark Mayor Cory Booker said the extent of the reported surveillance came as a surprise to him.

"If anyone in my police department had known this was a blanket investigation of individuals based on nothing but their religion, that strikes at the core of our beliefs and my beliefs very personally, and it would have merited a far sterner response,'' he said.

"We're going to get to the bottom of this."

The report notes Newark's large Portuguese and Brazilian communities, but says that only information about "Islamic religious centers" and Muslim-owned businesses were gathered.

However, polls show that most New Yorkers strongly support the NYPD's counter-terrorism efforts.

On Tuesday, New York City Mayor Michael Bloomberg strongly defended the city's police department after university leaders protested over campus monitoring.

"The police department goes where there are allegations," Mr Bloomberg said.

"And they look to see whether those allegations are true. That's what you'd expect them to do. That's what you'd want them to do. Remind yourself when you turn out the light tonight."

Source

Wednesday, February 22, 2012

FDA Sets Path for Biotech Drug Copies

FDA Sets Path for Biotech Drug Copies

The Food and Drug Administration on Thursday created the first shortcut to the U.S. market for "biosimilar" drugs—cheaper versions of expensive and complex medicines made from biological matter.

Examples of such blockbuster drugs are erythropoietin for anemia, Remicade for rheumatoid arthritis and the cancer drug Herceptin. Erythropoietin alone costs the federal medical system an estimated $4 billion, and the FDA's guidelines for cheaper knockoffs are designed to put a dent in such ballooning medical costs. Versions of erythropoietin are made by Amgen Inc. and Johnson & Johnson. J&J sells Remicade in the U.S., and Roche Holding AG makes Herceptin.

The FDA's release of guidelines for the cheaper drugs sets out a series of steps that companies must comply with. It will be "an abbreviated pathway that will depend on existing data" on the already-existing, more-expensive drug, said Rachel Sherman, FDA associate director for medical policy.

"Instead of starting from scratch, these companies will be starting in the middle of the process," said Dr. Sherman. The new guidelines add details to the original proposal for introducing biosimilar drugs, contained in President Barack Obama's 2010 health overhaul.

The FDA action lags those in the European Union, which already has more than a dozen biosimilar drugs on the market.

Biologics are among the biggest-selling medicines today. In 2010, seven out of the top 20 selling drugs in the U.S. were biologics, led by anemia fighter erythropoietin, which has $3.3 billion in U.S. sales, according to Morgan Stanley Research. Biologics with $30 billion in U.S. sales are expected to lose patent protection by 2020, according to Bernstein Research.

Given the stakes, drug makers including Merck & Co., Novartis SA and Pfizer Inc. have stepped up efforts to develop knockoffs and tap into the market. Most recently, biotechnology giant Amgen said it was partnering with generic drug maker Watson Pharmaceuticals Inc. to develop unspecified biosimilars treating cancer.

Biologics are far more complex than other drugs generally, and so producing a true generic version—one that is chemically identical to the brand drug—isn't possible with today's technology. Left unanswered in the FDA's latest guidelines is whether the bio-knockoffs can use the same name as the original brand drug.

Sales of the knockoffs could reach $8 billion by 2020, Bernstein Research estimates. And they might be more lucrative than generic versions of small-molecule drugs, if the complexity of developing these larger molecules limits competition. Payers who were surveyed by Bernstein said they expect biosimilars to cost 10% to 20% less than the brand products. (Traditional generics can be as much as 90% cheaper.)

Yet companies must overcome technical, financial and commercial challenges. Amgen sought a partner in Watson because it wanted to share the $150 million to $200 million cost of developing a biosimilar, and because it lacked the skills a traditional generic drug maker like Watson had selling lower-cost medicines to health plans and hospitals.

"There are so many unknowns commercially," said Scott Foraker, who heads Amgen's year-old biosimilars unit. "We don't know what the competitive environment will look like. We don't know what the pricing will be. And there still is regulatory uncertainty."

Many of the knockoffs will be classified as comparable to branded biologics, but not copies that a pharmacist could automatically substitute. As a result, manufacturers expect they will have to do more than sell the therapies based on price, as companies do with traditional generics. They will have to promote biosimilars to doctors, as they do for brand-name drugs.

"The essence is not going to be a typical generics business," said Michael Kamarck, who's heading Merck's biosimilars effort. He said the brief history of biosimilars in Europe, where the medicines are approved, showed the need for "actively promoting" the medicines in order to get them used.

The market share for biosimilar versions of anemia therapy erythropoietin is less than 13% in France, while in Germany it is 72%, according to IMS Health, a data firm.

Manufacturers will have to get doctors to overcome their comfort and experience with using branded biologics and persuade them to prescribe something comparable, said Gillian Woollett, a biosimilars expert at consulting firm Avalere Health.

Source

Tuesday, February 14, 2012

Google Motorola bid approved in EU and US

Google Motorola bid approved in EU and US

Google Xoom tablet Google aims to strengthen its patent portfolio with the Motorola takeover

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US regulators have approved Google's $12.5bn (£7.9bn) bid for phone maker Motorola Mobility, hours after it won clearance from European authorities.

The European Commission ruled the deal would not raise competition issues in the market for operating systems for devices like mobile phones or tablets.

Regulators in the US agreed, although both authorities vowed to monitor the company and rivals' use of patents.

Approval from China, Taiwan and Israel is needed before the deal is completed.

Motorola split in two last year, prompting Google to bid for the section that makes phones and tablet computers in a bid to gain access to more than 17,000 of Motorola Mobility's patents.

'Important milestone'

EU Competition Commissioner Joaquin Almunia said in a statement that regulators did not think the deal would diminish competition.

But he added: "The commission will continue to keep a close eye on the behaviour of all market players in the sector, particularly the increasingly strategic use of patents."

Last month, European regulators launched an investigation into whether Samsung was using some of its key patents to hinder competitors.

Google vice-president Don Harrison said in a blog post the EU approval was an "important milestone" which moved the company closer to closing the deal.

Android access

"As we outlined in August, the combination of Google and Motorola Mobility will help supercharge Android," he said.

"It will also enhance competition and offer consumers faster innovation, greater choice and wonderful user experiences."

The European Commission had originally intended to rule on the deal by 10 January but delayed its decision after requesting more information.

It wanted to examine whether Google might favour Motorola Mobility by making it harder for big-selling handset manufacturers, like Samsung or HTC, to use its Android operating system.

However, the commission concluded: "It is unlikely that Google would restrict the use of Android solely to Motorola, a minor player in the European Economic Area."

Source

Thursday, January 19, 2012

Can a company live forever?

Can a company live forever?

Stora Enso image
In 1288, Stora Enso issued the first share ever granted in a company, giving a bishop an eighth of a copper mountain

The past few years have seen previously unthinkable corporate behemoths - from financial firms such as Lehman Brothers to iconic car manufacturers such as Saab - felled by economic turmoil or by unforgiving customers and tough rivals.

And do not put away the black garb yet - the pace of corporate funerals is set to pick up.

The average lifespan of a company listed in the S&P 500 index of leading US companies has decreased by more than 50 years in the last century, from 67 years in the 1920s to just 15 years today, according to Professor Richard Foster from Yale University.

Today's rate of change "is at a faster pace than ever", he says.

Professor Foster estimates that by 2020, more than three-quarters of the S&P 500 will be companies that we have not heard of yet.

So in a world where former titan General Motors was brought to its knees a couple of years ago, requiring a government cash injection to escape bankruptcy, it seems apt to ask: How long can a company survive?

Looking eastward
Lehman Brothers headquarters in New York City The implications can be enormous when large companies go under

It is perhaps unsurprising that the country where people live the longest is also home to some of the oldest companies in the world.

In Japan, there are more than 20,000 companies that are more than 100 years old, with a handful that are more than 1,000 years old, according to credit rating agency Tokyo Shoko Research.

The list includes Nissiyama Onsen Keiunkan, a hotel founded in 705, which is thought to be the oldest company in the world.*

There is even a specific word for long-lived companies in Japanese: shinise.

So what is the key to their longevity?

"Japanese companies can survive for so long," according to Professor Makoto Kanda at Meiji Gakuin University, "because they are small, mostly family-run, and because they focus on a central belief or credo that is not tied solely to making a profit."

Local factors could be another key to their success, he says.

Shinise focus primarily on the Japanese market, from Kikkoman's products to small sake manufacturers, and they benefit from a corporate culture that has long avoided the mergers and acquisitions that are common among their Western counterparts.

"Those conditions must be sustained," says Professor Kanda. "Otherwise it will be a little bit difficult for them to continue live long."

Predicting the future

But, of course, conditions do change - and what then?

Nokia Galoscher poster from the 1920s Changing with the times is essential for companies that want to survive for a long time

Although there are exceptions to every rule, the most important factor for survival is an emphasis on innovation and reinvention.

Nokia was a pulp manufacturer before it got into electricity and then mobile phones; at some point its brand name was even used on galoshes. Or take Berkshire Hathaway, which began as a textile mill in Rhode Island.

However, innovation for the sake of it is not the goal, says Vicki TenHaken, a professor of management at Hope College.

It is a focus on "little bets" that helps companies grow and keep up with the competition, she says.

In fact, the world's oldest limited liability corporation, the Finnish paper and pulp manufacturer Stora Enso, first started out as a copper mining company in 1288.

Now the company is looking into expanding into bio-energy and green construction materials, areas that it has spent several years developing.

"The next 40 years look very different from the 700 years behind us," says Stora Enso spokesman Jonas Nordlund, emphasising the company's desire to expand outside Europe in Brazil, China and Uruguay, as well as its investment in cross-laminated timber, a building material that sequesters carbon dioxide.

Balancing act
DuPont scientist Research and development may be expensive, but it might help secure long-term survival

Innovation in general is not always easy, however, especially for publicly listed companies that must balance the concerns of capital markets and shareholders, who demand quarterly profits and who are not necessarily interested in decades-long research projects.

"Research and development is always a delicate balance between maintaining a long-term view and remaining sensitive to short-term financial objectives," observes Mark Vergnano, executive vice president of innovation at DuPont.

Mr Vergnano cites DuPont's trove of more than 37,000 patents and its early history as a gunpowder manufacturer as proof of its commitment to innovation - but acknowledges that inventions are not enough to keep the company operating from day to day.

DuPont implemented a new rule in 2010 that mandated that 30% of revenue must come from innovations the company has created in the last four years - a move that could help reassure investors who might balk at the company's $2bn research and development budget.

The problems of living forever

Yet even if a company can innovate and conditions do remain favourable, immortality does have its downsides.

For instance, there is no real proof that age makes a company any more profitable than younger companies. On the contrary, evidence from the stock market actually suggests that age could be a hindrance.

An advertisement for General Motors is displayed near the company's headquarters in Detroit, Michigan When GM filed for bankruptcy, the US government had to come to the rescue to prevent its downfall

Of the 74 or so companies that have stayed in the S&P 500 for more than 40 years, only a dozen or so have managed to beat the average, according to a study by consultancy McKinsey.

In fact, if the S&P 500 were made up of only the companies that were part of the index in 1957, overall performance would have been some 20% worse.

"When a company has run its course it gets bought," says Professor Foster.

"This is a good thing, because if the economy stops changing then productivity would go away.

"All companies would like to think that they're going to be the Methuselah, but they're not."

When to die?

Ms TenHaken agrees, although she also emphasises the toll that unplanned for or sudden deaths can have on surrounding communities - particularly her home of Michigan, which has seen its fair share of corporate funerals.

"I don't know that it's necessary to say that companies should live forever," she says.

"I think the tragedy is that companies die premature deaths. If a company dies too soon we have to ask what went wrong."

As more and more companies look set to take their final bow, the real question for those who are left may not be how to survive, but when to die.

*There is some debate over the oldest company designation. There is an older organisation, Ikenobo Kadokaia, which was founded in Kyoto in 587 AD. However, its stated purpose is the promotion of traditional floral arranging, which is not necessarily commercial in nature.

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The Big Winner of the Great Recession Is … Large Corporations

The Big Winner of the Great Recession Is …


Getty Images
Getty Images

The recent recession has been the most brutal since the Great Depression and has caused enormous hardship for many American families, as well as immense financial problems for governments around the world. As a result, it’s hard to see the downturn that began at the end of 2007 as anything but a catastrophe. With household incomes generally lower and poverty rates significantly higher than they were 10 years ago, it’s easy to feel that everything is falling apart. But amid the wreckage, there are some success stories that are vitally important for the recovery and the future prosperity of America.

The big winners of the recent Great Recession have been the largest U.S. corporations. This isn’t simply because they are greedy and rapacious, or because they can steamroller everything in their path. Rather, it reflects the fact that they are in a position to use the recession as a positive opportunity to restructure and become more efficient, while government, small businesses and most American households are forced by circumstances to play defense.

In every economic system, there have to be occasional corrective phases, where inefficient and uncompetitive businesses and services are eliminated, costs are lowered, and ground is cleared for new growth. But not every part of the economy is equally well positioned to do this. Government usually has to worry first about unemployment. It therefore tries to preserve current jobs and existing businesses, rather than focusing on restructuring government services to make them more effective or reforming social programs to lower their long-term costs. Most households and many small businesses give top priority to immediate concerns in a recession, because they have to respond to the short-term pain rather than the potential for long-term gain.

(More: What S&P’s Downgrades Mean for the Euro’s Future)

The organizations that have the resources to think about the future and position themselves accordingly are typically the largest corporations. Sure, some big companies have failed – most notably banks – but most have been able to take advantage of reduced labor costs and low interest rates to boost their productivity at the same time that they are strengthening their balance sheets. Consider the following:

Labor costs are down while productivity is up. The most recent data from the Bureau of Labor Statistics show that quarterly productivity in manufacturing rose 5%, while unit labor costs declined 5.1%. Basically, as companies shut down their least successful business operations, they are left with the most efficient and productive ones. Moreover, wages are not keeping pace with inflation right now. In fact, adjusted for inflation, they are down 2.3% from a year ago, the biggest such decline since 1948. The overall result is that companies are getting more from their workers without having to pay them more.

Top companies are able to refinance their debt at low interest rates. The Federal Reserve’s policy of quantitative easing has made plenty of money available at low interest rates. Giant corporations with excellent credit ratings can therefore restructure their balance sheets any way they want – boosting cash on hand or locking in long-term borrowing exceptionally cheaply. As a result, the value of corporate balance sheets has risen by 28% since late 2009. Much of the needed refinancing has now been completed, although some companies, such as GM and Ford, still have big bond offerings coming up.

(VIDEO: The 99ers: The Real Lives of the Long-Term Unemployed)

Money is rolling in. Higher productivity, moderate labor costs and restructured balance sheets combine to make companies more profitable. In fact, corporate profits are now at a peak in dollar terms and close to an all-time high as a percentage of GDP. Overall, profits have more than doubled since 2000, while stock prices are actually lower than they were 12 years ago. What that means is that lots of great stocks are now cheap by historical standards.

Corporate cash holdings are immense. Nonfinancial companies are taking in hundreds of billions of dollars more than they need to fund current operations. Total cash reserves at U.S. corporations total more than $2 trillion, close to a 50-year high in relative terms. Perhaps not surprisingly, some of the companies with lots more cash on hand than they need are paying ample dividends. Oil giant Chevron, with $20 billion in cash, now offers a 3.1% yield. Chipmaker Intel, with $15 billion, now pays 3.3%. And health-care conglomerate Johnson & Johnson, with $30 billion, yields 3.5%. (I give a longer list of companies that are likely to grow dividends here.)

In part, these huge cash reserves reflect the uncertainty corporate executives feel about whether to expand right now. Demand is still soft, government policy on taxes and regulations is confused, and risks of a currency collapse in Europe are impossible to gauge. As a result, many U.S. companies are simply hunkering down and hanging onto their money until the picture gets clearer.

There’s no guarantee, of course, that the U.S. economy will continue to get better. Recent small improvements could suddenly be reversed – for example, by upheaval in Europe that leads to a worldwide double-dip recession. But at least most U.S. businesses are in better shape than they were a couple of years ago. And once a sustainable recovery does get under way, the companies that have been able to make the most of the recession’s opportunities are likely to prosper in the years to come.

Andrew Sullivan Is Wrong About Obama's Liberal Critics

Andrew Sullivan Is Wrong About Obama's Liberal Critics



'Weak-Kneed' Obama Killed Public Option - New Book


Sunday, November 20, 2011

Snorting cocaine 'threatens Colombian national security'

Snorting cocaine 'threatens Colombian national security'

Colombia's president is calling on foreign governments to take more responsibility for illegal drug use in their countries.

President Santos, who is in the UK for a two-day visit, told the BBC that "as long as people in London, New York and Paris are sniffing cocaine, we will suffer".

He described it as a matter of national security for Colombia and said drug consumption overseas helped finance both local mafia and political groups involved in a decades-old violent struggle to overthrow the government.

Mr Santos claimed a victory earlier this month when the leader of the Revolutionary Forces of Colombia, or Farc, was killed.

He told the BBC's Alastair Leithead that it was an important step towards peace in his country.

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Friday, October 28, 2011

Why College Tuition Should Be Regulated

Why College Tuition Should Be Regulated

Forget about student loan repayment caps and tuition price calculators. It's time for the government to rein in the soaring costs of higher education

John Moore / Getty Images
John Moore / Getty Images
President Obama speaks at the University of Colorado, Denver campus on Oct. 26.

Goodman is the author of College Admissions Together: It Takes a Family.

Tuition at Stanford University in 1980-81 was $6,285. Thirty years later, Stanford’s tuition had risen to $38,700. Tuition in 2011-12 is $40,050. If the cost of milk had grown at the same rate, a gallon of milk would now cost approximately $15.

I haven’t yet purchased $15 gallons of milk, but as a college advisor I have counseled many students who are charged $50,000 per year for tuition, fees and campus housing. According to just released figures from the Commonfund Institute, the inflation rate for colleges and universities was 2.3% for fiscal year 2011, more than double the rate for 2010 and reversing a decelerating trend that began in 2008. Stanford, which estimates that 75% of its undergraduates receive financial aid, is not out of the norm. Drexel University, Carleton College and the Stevens Institute of Technology were among the 72 other schools that were more expensive than Stanford last year.

(MORE: The 24 Most and Least Affordable Colleges)

Since loans now comprise 70% of financial aid packages, the growing tuition burden falls squarely on student-borrowers who may have saved for college but who still can’t meet the high cost of attendance. Two-thirds of American undergraduates are in debt. This year, student loan debt will grow to more than a trillion dollars, outpacing credit card debt for the first time. As hundreds of thousands of high school seniors prepare their college applications, and their parents compile documents required for financial aid, Congress needs to seriously consider legislation that will rein in future tuition increases.

There are many reasons for the dramatic rise in tuition, including demand for better student residences, cutting-edge laboratories, IT improvements, cuts in state subsidies and administrative growth. Regardless of which factors are most significant, the fact remains that there has simply not been enough external pressure to force universities to contain costs. Ironically, the accessibility of student loans, while admirable at first glance, has contributed to tuition growth. And while President Obama’s recent proposal to cap student loan repayments depending on income is a step in the right direction, it doesn’t address the bigger problem of runaway tuition in the first place.

This is where government needs to firmly step in. The federal government contributes billions of dollars to research and development on campus and allows universities to function as tax-exempt institutions. Self-policing of college costs has not worked; government needs to tie its support of higher education to college costs.

(MORE: A New ‘Poor Students Need Not Apply’ Policy At College?)

If universities raise tuition more than the Consumer Price Index, they should be required by Congress to take money from their endowments to fully fund grants for the corresponding increase in need for students on financial aid. The 20 wealthiest universities alone are sitting on endowment funds worth $200 billion. Three-hundred and sixty-seven colleges and universities control tax-exempt endowments worth over $100 million.

To enforce the new guidelines, Congress and the Department of Education should create a commission that includes representatives of universities, Fortune 500 employers, consumer advocates and economists. Perhaps this could be a more expansive version of the 2005-06 Spellings Commission, which charted the future of higher education and suggested — but didn’t mandate — ways to better prepare students for the workplace. If universities don’t comply with the new guidelines, they will lose their 501(c)(3) status — a great incentive to control tuition costs rather than pay taxes on donations and endowment earnings and lose the ability to qualify for tax-exempt financing of infrastructure projects.

Admittedly, we need to strike a careful balance. We want to respect academic freedom and the ability of educational institutions to plan their own futures, but we can’t allow universities to continue offloading rising costs on to the backs of the vast majority of students and families. Congress urgently needs to pass legislation that will prevent university costs from bankrupting the next generation of today’s youth.


Grayson: It's Class Warfare vs. Class Surrender

Grayson: It's Class Warfare vs. Class Surrender

With A Stroke Of His Pen Obama Strikes Back At Citizens United

A little over a year ago the Supreme Court of the United States made a controversial ruling that says corporate funding of independent political broadcasts in candidate elections cannot be limited. The case known as Citizens United v Federal Election Commission allows corporations to use their general funds to buy campaign ads that was prohibited under federal law, and opened the door for unlimited contributions by corporations as well as unions. The high court cited the 1st Amendment’s guarantee of the right of free speech, and it was the first time a corporate entity was treated like a person. Detractors of the ruling cried foul and correctly pointed out that, “The Supreme Court has handed lobbyists a new weapon. A lobbyist can now tell any elected official: if you vote wrong, my company, labor union or interest group will spend unlimited sums explicitly advertising against your re-election.” The ruling also opened the door for foreign governments to affect the outcome of United States elections.

There was an attempt to assuage the damage from Citizens United in the form of the Disclose Act that passed in the Democratic controlled House last year but failed in the Senate because Democrats couldn’t muster the super majority needed to overcome Republican’s filibuster threat. The failed legislation provided tough new disclosure rules for groups that invest in the election process. President Obama summed up the necessity of the Disclose Act calling it “a critical piece of legislation to control the flood of special interest money into our elections,” and, “that it mandates unprecedented transparency in campaign spending, and it ensures that corporations who spend money on American elections are accountable first and foremost to the American people.” Since Republicans are enamored with the notion of unlimited special interest money without transparency or accountability, it was not surprising they threatened to filibuster the measure. The 2010 midterm elections confirmed Americans’ fears with money from special interest groups and corporations flooding the airwaves with fallacious assertions and inaccurate characterizations of everything from the health law to socialist tendencies of Democratic candidates. It appeared that since the Disclose Act failed, elections would be bought by the highest bidder for years to come, but a report today gives some hope that democracy is not dead in America; yet.

On Wednesday it was reported that President Obama was drafting an executive order that would require companies pursuing federal contracts to disclose political contributions that have been secret under the Citizen’s United ruling. A senior fellow at the Heritage Foundation, Hans A. von Spakovsky, lambasted the proposed executive order saying that, “The draft order tries to interfere with the First Amendment rights of contractors.” Mr. von Spakovsky dutifully made all the right-wing, neo-con arguments including bringing Planned Parenthood and unions into the discussion. The draft order did not exempt any entity from disclosure rules and presents a reasonable requirement on contractors seeking government contracts. Several states have similar “pay to play” laws to prevent businesses from using unlimited donations to buy lucrative state contracts from slimy legislators. Thus far the only legislator who has railed against the proposed order was Senate minority leader Mitch McConnell (R-KY). McConnell called the proposal an “outrageous and anti-Democratic abuse of executive branch authority,” and went on to say, “Just last year, the Senate rejected a cynical effort to muzzle critics of this administration and its allies in Congress.”

McConnell is working under the assumption that the draft order is an attempt to restrict free speech, but there is nothing in the order remotely resembling free speech violations. The exact wording of the president’s executive order says, “The Federal Government prohibits federal contractors from making certain contributions during the course of negotiation and performance of a contract.” There is no free speech issue and the order applies to union contractors as well as non-union contractors. There is no special dispensation of muzzles or prohibitions on political support; only certain contributions during negotiations and performance. Republicans must hate the idea of corporations like Halliburton or Koch Industries losing the ability to contribute unlimited money to legislators for special treatment in securing government contracts, especially no-bid contracts like the ones Dick Cheney’s company’s received in Iraq and Afghanistan. In lieu of veracity, McConnell accuses President Obama of muzzling critics and suppressing free speech when in fact, the order will bring increased transparency and accountability to the process of awarding contracts. Republicans made it their goal to increase transparency and accountability in government in the lead up to the midterm elections, so McConnell should be thrilled that President Obama is helping them achieve their goal.

The real objection Republicans and the Heritage Foundation have with the order is that it removes the possibility of corporate money influencing government more than it already does. The Citizens’ United ruling was a gift to Republicans who do the bidding of corporations in exchange for campaign contributions and it became obvious after reports that two Supreme Court Justices attended a secret Koch Industries strategy meeting prior to voting to extend free speech rights to corporations just in time for the 2010 midterm campaigns.

The midterm elections saw a record amount of campaign contributions from anonymous sources that were illegal for years until the high court broke with precedent and gave personhood to corporations. The rash of Republican governors’ victories and subsequent corporate favoritism and tax cuts at the expense of poor and working class Americans is evidence that there is a serious need for accountability and transparency in campaign financing.

The response from McConnell and the Heritage Foundation is not unexpected and is most likely the tip of the iceberg as far as criticism and false indignation are concerned. The screed from Hans A. von Spakovsky of the Heritage Foundation is a preview of the propaganda right-wing outlets like Fox News and their pundits will spew on an hourly basis once the order becomes common knowledge.

Conservatives are not known for their veracity, and based on von Spakovsky’s portrayal of the order, there is no telling how Fox, Limbaugh, Beck and myriad Republican presidential hopefuls will spin the story, or to what end their faux outrage will take. One thing is certain; Republicans will make the order tyrannical and un-Constitutional before the dust settles and that should be a signal that the president’s proposal is appropriate and in keeping with democratic principles of fairness. Of course, any attempt at ensuring fairness in government is contrary to Republican principles of corruption, fear mongering, and doing the bidding of the Heritage Foundation.

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Tuesday, October 25, 2011

The Narco-Killer's Tale: Confessions of a Justified Sinner

The Narco-Killer's Tale: Confessions of a Justified Sinner
By Ioan Grillo


In his comprehensive and compelling new book, El Narco: Inside Mexico's Criminal Insurgency, British correspondent Ioan Grillo, who also reports for TIME, narrates the Mexican underworld's "radical transformation from drug smugglers into paramilitary death squads ... a criminal insurgency that poses the biggest armed threat to Mexico since its 1910 revolution." Grillo outlines both the Mexican and American policy failures that fostered the crisis, which has produced 40,000 murders south of the border since 2006. More important, he offers a rare and unsettling look into the lives of ordinary Mexicans and other Latin Americans "sucked into [the drug war] or victimized by it." An excerpt:

It all seemed like a bad dream.

It may have been vivid and raw. But it felt somehow surreal, like Gonzalo was watching these terrible acts from above. Like it was someone else who had firefights with ski-masked federal police in broad daylight. Someone else who stormed into homes and dragged away men from crying wives and mothers. Someone else who duct-taped victims to chairs and starved and beat them for days. Someone else who clasped a machete and began to hack off their craniums while they were still living.(See photos of a siege in Cuidad Juárez.)

But it was all real.

He was a different man when he did those things, Gonzalo tells me. He had smoked crack cocaine and drunk whisky every day, had enjoyed power in a country where the poor are so powerless, had a latest model truck and could pay for houses in cash, had four wives and children scattered all over ... had no God.

"In those days, I had no fear. I felt nothing. I had no compassion for anybody," he says, speaking slowly, swallowing some words.

His voice is high and nasal after police smashed his teeth out until he confessed. His face betrays little emotion. I can't really take in the gravity of what he is saying — until I play back a video of the interview later and transcribe his words. And then as I wallow over the things he told me, I have to pause and shudder inside.(Read about how Mexico's drug war may become its Iraq.)

I talk to Gonzalo in a prison cell he shares with eight others on a sunny Tuesday morning in Ciudad Juárez, the most murderous city on the planet. We are less than seven miles from the U.S. and the Rio Grande that slices through North America like a line dividing a palm. Gonzalo sits on his bed in the corner clasping his hands together on his lap. He wears a simple white T-shirt that reveals a protruding belly under broad shoulders and bulging muscles that he built as a teenage American football star and are still in shape at his 38 years. Standing 6 ft. 2 in., he cuts an imposing figure and exhibits an air of authority over his cellmates. But as he talks to me, he is modest and forthcoming. He bears a goatee, divided between a curved black moustache and gray hairs on his chin. His eyes are focused and intense, looking ruthless and intimidating but also revealing an inner pain.

Gonzalo spent 17 years working as a soldier, kidnapper and murderer for Mexican drug gangs. In that time he took the lives of many, many more people than he can count. In most countries, he would be viewed as a dangerous serial killer and locked up in a top security prison. But Mexico today has thousands of serial murderers. Overwhelmed jails have themselves become scenes of bloody massacres: 20 slain in one riot; 21 murdered in another; 23 in yet another: all in penitentiaries close to this same cursed border.

Within these sanguine pens, we are in a kind of sanctuary — an entire wing of born-again Christians. This is the realm of Jesus, they tell me, a place where they abide by laws of their own "ecclesiastical government." Other wings in this jail are segregated between gangs: one controlled by the Barrio Azteca, which works for the Juárez Cartel; another controlled by their sworn enemies the Artist Assassins, who murder for the Sinaloa Cartel.

The 300 Christians try to live outside of this war. Baptized Libres en Cristo, or "Free Through Christ," the sect founded in the prison borrows some of the radical and rowdy elements of Southern U.S. Evangelicalism to save these souls. I visit a jail-block mass before I sit down with Gonzalo. The pastor, a convicted drug trafficker, mixes stories of ancient Jerusalem with his hard-core street experiences, using slang and addressing the flock as the "homies from the barrio." A live band blends rock, rap and norteño music into their hymns. And the sinners let it all out, slam-dancing wildly to the chorus, praying with eyes closed tight, teeth gritted, sweat pouring from foreheads, hands raised to the heavens — using all their spiritual power to exorcise their heinous demons.

Gonzalo has more demons than most. He was incarcerated in the prison a year before I met him, and bought his way into the Christian wing hoping it was a quiet place where he could escape the war. But when I listen carefully to his interview, he sounds like he really has given his heart to Christ, really does pray for redemption. And when he talks to me — a nosy British journalist prying into his past — he is really confessing to Jesus.

"You meet Christ and it is a totally different thing. You feel horror, and start thinking about the things you have done. Because it was bad. You think about the people. It could have been a brother of mine I was doing these things to. I did bad things to a lot of people. A lot of parents suffered."

Read about activists marching against Mexico's drug war.

"When you belong to organized crime you have to change. You could be the best person in the world, but the people you live with change you completely. You become somebody else. And then the drugs and liquor change you."

I have watched too many videos of the pain caused by killers like Gonzalo. I have seen a sobbing teenager tortured on a tape sent to his family; a bloodied old man confessing that he had talked to a rival cartel; a line of kneeling victims with bags over their heads being shot in the brain one by one. Does someone who has committed such crimes deserve redemption? Do they deserve a place in heaven?(Read about Mexico bracing for a deadlier drug war after a bombing.)

Yet, I see a human side to Gonzalo. He is friendly and well mannered. We chat about lighter issues. Perhaps in another time and place, he could have been a stand-up guy who worked hard and cared for his family — like his father, who, he says, was a lifelong electrician and union man.

I have known angry, violent men in my home country; hooligans who smash bottles into people's faces or stab people at soccer games. And on the surface, those men seem more hateful and intimidating than Gonzalo as he talks to me in the prison cell. Yet they have killed nobody. Gonzalo has helped turn Mexico at the dawn of the 21st century into a bloodbath that has shocked the world.

In his 17 years in the service of the mafia, Gonzalo witnessed extraordinary changes in the Mexican drug industry.

He began his career in Durango, the mountainous northern state that is the proud birthplace of Mexican revolutionary Pancho Villa. It is also near the heartland of smugglers who have taken drugs to America since Washington first made them illegal. After dropping out of high school and abandoning his hopes of becoming an NFL quarterback, Gonzalo did what many young tough nuts in his town did: he joined the police force. It was here he learned the highly marketable skills of kidnapping and torture.(Read to see if Mexico's narcos are fighting scared.)

The path from policeman to villain is alarmingly common in Mexico. Major drug lords, such as the 1980's "Boss of Bosses" Miguel Angel Felix Gallardo, began as officers of the law, as did notorious kidnapper Daniel Arizmendi, alias the Ear Lopper. Like them, Gonzalo left the police after a reasonably short stint, deserting when he was 20 years old to pursue a full-time criminal career.

He arrived in Ciudad Juárez and did dirty work for an empire of traffickers who smuggled drugs along a thousand miles of border from east of Juárez to the Pacific Ocean. The year was 1992, glorious days for Mexico's drug mafias. A year earlier, the Soviet Union had collapsed and governments across the world were globalizing their economies. A year later, Colombian police shot dead cocaine king Pablo Escobar, signaling the beginning of the demise of that country's cartels. As the 1990s went on, Mexican traffickers flourished, moving tons of narcotics north and pumping back billions of dollars amid the surge in free trade created by NAFTA. They replaced Colombians as the dominant mafia in the Americas. Gonzalo provided muscle for these gangster entrepreneurs, pressuring (or kidnapping and murdering) anyone who didn't pay their bills. And he became a rich man, earning hundreds of thousands of dollars.

But by the time of his arrest 17 years later, his job and his industry had changed drastically. He was leading heavily armed troops in urban warfare against rival gangs. He was carrying out mass kidnappings and controlling safe houses with dozens of victims bound and gagged. He was working with high-ranking city police officers, but fighting pitched battles against federal agents. And he was carrying out brutal terror, including countless decapitations. He had become, he tells me, a man he did not recognize when he stared in the mirror.

"You learn a lot of forms of torture. To a point you enjoy carrying them out. We laughed at people's pain — at the way we tortured them. There are many forms of torture. Cutting off arms, decapitating. This is a very strong thing. You decapitate someone and have no feeling, no fear."

Understanding the Mexican drug war is crucial not only because of morbid curiosity at heaps of severed-brain cases — but because the problems in Mexico are being played out across the world. We hear little about communist guerrillas in the Americas these days, but criminal uprisings are spreading like bushfire. In El Salvador, the Mara Salvatrucha forced bus drivers into a national strike over anti-gang laws; in Brazil, the First Command torched 82 buses, 17 banks and killed 42 policemen in one coordinated offensive; in Jamaica, police clashed with supporters of Christopher "Dudus" Coke, leaving 70 dead. Are pundits going to insist this is just cops and robbers? The Mexican drug war is a frightening warning of how bad things could get in these other countries; it is a case study in criminal insurgency.

Many Salvadoran gang bangers are the sons of communist guerrillas — and call themselves combatants just like their fathers. But they don't care about Che Guevara and socialism, just money and power. In a globalized world, mafia capitalists and criminal insurgents have become the new dictators and the new rebels. Welcome to the 21st century.

From El Narco: Inside Mexico's Criminal Insurgency. Copyright© 2011 by Ioan Grillo. Published by Bloomsbury Press.

See photos about coming to age in Ciudad Juarez.
Read about Mexico's lost generation.





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