Thursday, March 1, 2012

News and Events - 02 Mar 2012




28.02.2012 23:47:55
Chris Berg

It doesn't take more than a moment of thought to recognise that the rulings on which drugs are legal or illegal are governed by no particular logic.

No theory from medicine or philosophy or psychology demands alcohol, tobacco and caffeine must be legal while marijuana, cocaine, and heroin must be prohibited.

We cannot rely on distinctions about relative harm. Many experts have pointed out that marijuana is on balance less dangerous than alcohol. But this legal discord isn't unusual. One British police chief controversially stated a few years ago that ecstasy is safer than aspirin.

Nor is the distinction between recreational or medicinal use any help. There are legal and illegal drugs that fall on both sides of that artificial line.

The generally accepted definition of the word "drug" offers no guide to legality either: "any substance other than food which by its chemical nature affects the structure or function of the living organism".

Whether a drug is illegal is nothing more than an accident of history. Drug laws were not written dispassionately by a panel of the best medical and ethical minds in the world. The laws bear no relation to the damage those drugs could cause or their danger to society – they were not written to minimise harm or protect health.

Quite the opposite: the current schedule of drugs in the Western world has been driven by politics, expediency, prejudice, and sometimes outright racism.

Take, for instance, the prohibition that kicked it all off – the prohibition on opium.

In 19th century Britain, opium was so common as to be part of everyday life. It was an essential ingredient in tonics and pick-me-ups. One writer claimed in the 1870s that opium use "may indeed be said to have reached the height of Fashion".

Few British conceived of a drug "problem". Certainly, there were dramatic, gothic tales of addiction and vice. Thomas de Quincey's novel Confessions of an English Opium-Eater is the most well-known. And there were some distressing, but not representative stories of overdose. But, culturally, moderate drug use was normal.

And the medical establishment largely accepted this. When reporting on the Royal Commission on Opium in 1893, the iconic journal Lancet described it as a "crushing blow to the anti-opium faddists".

There was however, an "opium problem" in Australia and the United States. The difference was race. In both countries there was a significant Chinese minority who had brought their country's opium smoking habit with them. The first war on drugs was a proxy for racial politics, not public health.

"Who has not seen the slave of opium?," the Victorian minister of health asked parliament at the end of the 19th century: "a creature tottering down the street, with sunken yellow eyes, closely contracted pupils, and his skin hanging over his bones like dirty yellow paper."

The issue here, clearly, was not opium but the Chinese.

Unsurprisingly this attitude towards opium was hard to separate from the belief Chinese migrants were undercutting Australians in the employment market. The visceral hatred of opium-smoking was the manifestation of resentment about labour competition.

It was the same in the United States. As the British writer Christopher Snowdon points out in his excellent new book The Art of Suppression, "if the government could not get rid of opium-smoking, it would get rid of opium-smokers".

The 1862 Californian law
Protect Free White Labor Against Competition with Chinese Coolie Labor and Discourage the Immigration of the Chinese into California Act
is self-explanatory.

One of the most prominent American anti-opium campaigners, Dr Harry Hubbell Kane, openly argued that those concerned about job competition should focus their animosity on Chinese drug use.

It is easy to tell a parallel history of marijuana prohibition, which was overwhelmingly used by Hispanics and African-Americans.

And in his book, Snowdon details the tabloid hysteria of recent times which has led to laws against "designer" drugs – synthetic concoctions which are better described as second-rate substitutes for safer, purer, and already prohibited drugs.

Do the political origins of drug laws matter? Absolutely.

The first international treaty on drug control was signed in January 1912. The war on drugs is 100 years old this year.

This century-long war has definitively and undeniably failed. There is widespread belief in expert circles that the world needs to move towards decriminalisation (or even legalisation if we want to minimise the harm of drug abuse.

But the biggest cultural barrier to such reform is the current status illegal drugs have. In the sort of circular reasoning that only popular discourse can manage, the prohibition of drugs is mostly justified by their pre-existing legal status. Why are certain drugs prohibited? Because they are illicit drugs.

But that status has been set by politics and moral panics, not dispassionate evidence-based risk assessments. Drug prohibition carries the legacy of the ugly politics of the past. Once we realise that, we may start to rethink the justice of a war that is, in truth, not against drugs, but against drug users.

Chris Berg is a Research Fellow with the Institute of Public Affairs. Follow him on Twitter
@chrisberg. View his full profile
here.




29.02.2012 0:58:00

Media_https1reutersme_fqkpq

By Aleksandar Vasovic and Ben Hirschler
BELGRADE | Wed Feb 29, 2012 3:13am IST
(Reuters - According to a signal from the electronic tag around his ankle, Nenad Borojevic last left his apartment building at 6.25 p.m. on January 10. It was the festive season in Serbia; the capital was enjoying the lull between Orthodox Christmas and New Year.

Police said Borojevic, a doctor, headed to Kosutnjak park, a popular wooded area in Belgrade dotted with restaurants and criss-crossed by jogging paths.

Borojevic had been one of Serbia's most eminent doctors, a director of the Institute for Oncology and Radiology. Now he was due in court in five days to face charges brought by the public prosecutor that he had taken bribes from international drug companies as incentives to use their products. The electronic tag was a condition of his 500,000 euro ($660,000 bail.

The next day, around noon, a passer-by found Borojevic hanging from a tree on a nylon rope five millimeters thick. Police found a suicide note in the mailbox of his wife, from whom he was separated. It had been sent from a local post office. "I couldn't take it anymore," it said.

Borojevic's story, some of which emerges here for the first time, is a particularly gruesome example of what even people in the global drugs business concede is a growing problem: bribery and corruption in emerging markets. The 51-year-old cancer specialist was one of a group of 10 Serbia-based doctors and drug company officials charged in 2010 with taking, or offering, more than 500,000 euros in bribes to persuade the medics to use specific products. The doctors are alleged to have personally gained from the choice of medicines used; the drug company representatives with illegally offering the incentives.

In recent years, Big Pharma has forked out billions of dollars to settle scandals involving improper promotion of medicines in the United States. Now bribes paid to foreign doctors and other state employees are shaping up as the next major legal liability threat for the industry. A Reuters examination of U.S. Securities and Exchange Commission (SEC filings by the world's top 10 drug companies has found that eight of them recently warned of potential costs related to charges of corruption in overseas markets.

One factor driving the trend is a search for new business. Companies whose profit margins have been squeezed in the developed world are increasingly turning to thinly regulated emerging markets for growth. At the same time, U.S. and European governments are toughening up on bribes paid by companies overseas. The U.S. Foreign Corrupt Practices Act and Britain's new Bribery Act, which came into force last July, are both targeting drugs companies for special scrutiny, providing new impetus for the industry to clean up its act.

"There's clearly a legal risk from violating laws with the current drive into emerging markets, so mis-selling cases in these markets could become a significant legal threat for the industry," said Chris Stirling, European sector leader for pharmaceuticals at KPMG in London. "The business practices in these countries are very different from the sort you find in Western Europe and the United States."

Borojevic's suicide - police have ruled out foul play - means certain aspects of his case, which is being investigated at a national level, may never be known. The trial of the other men and women in the group is continuing. All the defendants have pleaded not guilty, though one of the six drug company representatives involved agreed a plea bargain and another turned witness for the prosecution.

Emerging markets to drive pharma growth: link.reuters.com/ryw76s

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OPERATION CRAB

The probe of Borojevic, which police called Operation Crab, started with a tip-off in March 2007, according to a police source involved in the investigation.

At a later point, police received information from a former mistress of one of the accused, the investigator said, declining to name her. "After they broke up, she came to us and recited everything - names, places, contacts, how they operated, how much everyone received and from whom, when and where," said the investigator. "She even gave us some concrete evidence which helped us a great deal."

Some of Serbia's tabloid media said the informant was a former Serbian model, Katarina Rebraca, who herself, in a separate case, had in April 2010 faced charges of embezzling funds at a breast cancer charity she ran. Borojevic, the doctor, had been called as a witness for the prosecution against her, although he died before testifying.

Rebraca declined to comment. Her lawyer, Dragan Mrakovic, said: "It is not in the best interest of my client to give any information whatsoever" about the Borojevic case. "This has nothing to do with my client's case, nor does my client have anything to do with the pharmaceutical corruption case."

The informant led police to a rented apartment in Medakovic, a neighborhood of communist-era apartment blocks and family homes in Belgrade. Here a group of doctors and drugs company sales representatives would allegedly meet and hold "raunchy, loud parties with Belgrade babes, three or four times a week," said the police investigator. It was not possible to confirm who had rented the apartment.

In June 2010 police arrested Borojevic: the charges against him and four colleagues included running a criminal conspiracy in cancer drugs from 2007 to 2009. The indictment said that the alleged scheme, whereby drug company representatives gave inducements to the doctors to use their companies' products, had increased sales of a number of generic chemotherapy medicines as well as branded cancer medicines including Roche Holding AG's Avastin and Erbitux, made by Merck KGaA of Germany.

For Borojevic, the alleged gains were significant, especially in a country whose GDP per capita the IMF puts at just $6,500 a year. In total, he was accused of receiving a total of 11.2 million dinars ($138,000 in kickbacks from drug companies.

Officials at drugs companies AstraZeneca Plc, Sanofi SA and Actavis confirmed they were served in July and August 2011 with criminal indictments related to allegedly improper payments to physicians including Borojevic at his state-run institute, and said they had filed certain procedural objections. Icelandic pharmaceutical company Actavis gave the most expansive statement: "The allegations include bribery of state officials in order to obtain preferential status when it comes to the sale of oncology products in Serbia," said the company, which moved its headquarters to Zug, Switzerland in 2011.

All declined further comment on the proceedings. Also charged with alleged bribery in the case were representatives of Roche, Merck KGaA and PharmaSwiss - a unit of Canada's Valeant Pharmaceuticals International Inc - all of whom declined to comment.

REPS TAKE THE RAP

In one instance, the police allege, Borojevic and his colleague Zoran Bekic, head of the Institute for Oncology and Radiology's pediatric oncology ward, received 95,000 euros from Goran Orlic, a representative for Actavis. Orlic allegedly paid the men for inside information about its business plans.

The Actavis representative received immunity from prosecution in exchange for his testimony ahead of the trial, the court said in a statement. Actavis said Orlic left the company in 2009. Neither Bekic, the pediatrician, or his lawyer would comment. Orlic could not be reached.

Another of those charged was Merck KGaA's representative, Jasmina Gutovic. She reached a plea bargain with prosecutors and admitted giving bribes, according to the judge who heard her case. While Gutovic was convicted, the court will not say what punishment she received while the rest of the case is being heard. Merck KGaA confirmed she left the company in June 2011 and she could not be reached for comment.

The indictment against Borojevic also states that he and colleagues did a deal with unnamed drug company sales staff to develop "new therapeutic applications" using their companies' drugs, as a way of further boosting sales of the products. In the months before his death, Borojevic was portrayed in Serbian media as a poisoner of children, based on suggestions in the media that he had overprescribed.

Borojevic was released on bail in November 2011. He repeatedly denied all the charges against him, saying he was the victim of a media witch hunt. "Nothing is true from the indictment," he said in a statement in May 2011.

His lawyer, Strahinja Kastratovic, said that the day before Borojevic killed himself, he had learned the apartment he had bought with his estranged wife would be seized by the court. "He said, 'I can't take this anymore, I don't know how to fight this or against whom I'm supposed to be fighting,'" said Kastratovic. He declined to elaborate.

TEMPTATIONS INCREASE

Corruption is rife in Serbia, which is ranked 86th out of 183 countries in Berlin-based Transparency International's corruption perceptions index. The drugs business is particularly exposed to corruption, Transparency International says: pharmaceuticals create vast opportunities for graft across both rich and poor countries. Its 2011 Bribe Payers' Index ranks pharmaceuticals and healthcare 13th out of 19 industries on probity - a lower ranking than defense firms, though above mining and construction.

"There are a number of classic red flags for bribery that indicate the pharma sector is particularly vulnerable," says Robert Barrington, TI's director of external affairs. These include a tradition of gifts and hospitality, a lack of transparency over pricing and the need for regulatory approval in everything.

In many parts of the world lavish gifts such as all-expenses-paid trips to resorts and golf days remain common, even though the industry has reined in such hospitality in the United States.

Temptations may increase as companies move into the developing world. IMS Health, which analyses pharmaceutical industry trends, says 17 key emerging markets will account for around 63 percent of worldwide growth in prescription drug sales between 2010 and 2015.

"It is almost guaranteed that every multinational pharmaceutical company is going to end up with these issues and is going to have to go through a painful experience," says one in-house lawyer at a major U.S. drugmaker. "Frankly, the odds are stacked against companies."

'NOT ETHICAL, BUT UNIVERSAL'

The Serbian charges and claims of corruption extend beyond Borojevic and his colleagues. In his defense, Borojevic always insisted that he could not approve drug purchases alone, but passed on recommendations to the state-run Department of Health Insurance. That itself is the target of other, unrelated corruption charges brought by the public prosecutor against its former head, Svetlana Vukajlovic, who has been in pre-trial detention since September 2011.

An example from another Balkan country, Greece, underlines how ingrained such practices can be. Earlier this month, London-based Smith & Nephew Plc, Europe's biggest maker of artificial knees and hips, agreed to pay $22 million to settle SEC allegations that it bribed doctors in Greece to use its products. Among documents the SEC released as part of the dossier was a note jotted down in 1999 by an unnamed in-house lawyer for the company.

"Pay surgeon to use prod(uct ," it read. "Not legal or ethic; but universal."

In that case, the company's Greek distributor sent an email to the firm's U.S.-based head of international sales seeking to maintain access to one of the slush funds used to pay doctors to buy S&N products: "I absolutely need this fund to promote my sales with surgeons, at a time when competition offers substantially higher rates," he wrote. The fund's "only reason for being is the need for cash incentives, a real pain in the neck but an unavoidable fact of Greek life."

S&N CEO Olivier Bohuon, who took office in 2011, long after the alleged bribery occurred, said the company had moved on but the episode showed the need to remain vigilant.

Over the past year eight of the world's top 10 drugmakers - Pfizer Inc, Novartis AG, Merck & Co Inc, Sanofi, AstraZeneca, GlaxoSmithKline Plc, Johnson & Johnson and Eli Lilly & Co - have all warned that they may face liabilities related to charges of corruption in numerous overseas markets.

Investigations into potential wrongdoing by pharmaceutical firms cover activities in countries including Argentina, Brazil, Canada, China, Germany, Italy, Poland, Russia and Saudi Arabia, according to company filings. They also involve possible improper conduct of clinical trials, which are increasingly being run in lower-cost Asian or East European countries.

(For a report, see link.reuters.com/kyp76s .

'JUST SAY NO'

One reason such cases are surfacing now is the renewed vigor with which U.S. officials have enforced its foreign corruption law since November 2009. That's when U.S. assistant attorney-general Lanny Breuer told a pharmaceutical conference: "We will be intensely focused on rooting out foreign bribery in your industry."

The 1977 Foreign Corrupt Practices Act makes it illegal for U.S. companies and foreign firms whose stock is traded in the United States to bribe government officials in foreign countries. Officials at the U.S. SEC and Department of Justice (DOJ declined to say if they planned to follow the Serbian probe with their own investigations.

Some drug firms have already started to come clean. In the first case of its kind, Johnson & Johnson settled for $78 million with U.S. and British authorities in April last year, after disclosing voluntarily to U.S. authorities back in 2007 that it had made payments to doctors in Poland, Romania and Greece who chose to use J&J medicines and surgical implants.

Pfizer, which in 2004 became the first pharmaceutical company to volunteer information about past wrongdoings to the DOJ and the SEC, is likely to be the next big firm to settle. The world's biggest drugmaker, it reached an agreement in principle with U.S. authorities towards the end of last year and is set to finalize a deal during the first half of 2012, according to people familiar with the discussions.

Under U.S. and British law, the onus is on a corporation to report improper behavior by either its own staff or outside contractors. In some cases, this has already meant radical change. AstraZeneca, for example, said last May it was ending all payments to doctors attending international scientific and medical congresses.

"I know that this is not easy," Chief Executive David Brennan told a conference at the time. "I know from my own experience as a sales representative, you will encounter people who will ask for gifts, or other inducements. And they will threaten to take their business elsewhere, if you don't acquiesce. But we have made it clear that our sales force have to say no."

(Aleksandar Vasovic reported from Belgrade, Ben Hirschler from London; Edited by Sara Ledwith and Simon Robinson

(For PDF: link.reuters.com/xaz76s

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01.03.2012 3:14:00

An analysis of synthetic marijuana samples obtained after the April 1 order by the N.J. State Police forensics labs showed street chemists quickly adapted to the ban, creating roughly 18 new variants of the drug


Gallery preview

TRENTON — New Jersey’s recent battle with designer drugs has been a game of cat and-mouse.

Last year the state banned methamphetamine-like powders known as "bath salts."

But users moved to a similar, still-legal drug called "2CE."

And when chemicals used to make synthetic marijuana were banned, dealers found new ways to create the substances and sidestep the law.

Faced with a evolving problem that many are struggling to understand, Attorney General Jeff Chiesa today announced what he described as a sweeping solution to the designer drug problem:

Ban first. Ask questions later.

"Backyard chemists have been playing a cat-and-mouse game with law enforcement. We ban a specific chemical or compound … and they slightly alter it," he said.

Designer drugs are commonly described as synthetic compounds that can mimic the effects of street-sold drugs such as marijuana or heroin. They skirt laws because they are made from chemicals that are unknown to authorities and not covered by law.

Under the new ban, Chiesa said, any chemicals that mimic the effects of marijuana are now illegal in New Jersey, according to an emergency order issued today by the state Division of Consumer Affairs.

The ban lists 10 classes of chemicals, outlawing hundreds of compounds that could be used to create synthetic marijuanas.

He said it also bars the sale of any substances that might be used to create the drug in the future, a provision to illegalize compounds not specified in the ban. No chemicals listed in the ban are used in other products, he said.

The order was the latest effort in New Jersey to combat designer drugs.

Despite state and federal bans, the use of synthetic marijuana, commonly referred to as K2, ballooned last year

There were 146 reported abuse cases in the state in 2011, compared to 18 in 2010, according to the state Poison Center.

Across the country, reports of K2 use skyrocketed from 2,906 in 2010 to 6,959 last year, according to the National Poison Data System. Since 2010, the drug has been linked to 15 deaths nationwide.


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In New Jersey, the surge came as K2’s side effects worsened. Users suffered from surging heart rates, seizures, paranoid delusions and suicidal thoughts, said officials. These symptoms had been associated with bath salts — meth-like powders that made designer drugs a talking point in the Garden State last year.

Last April, Consumer Affairs Director Thomas Calcagni banned five chemicals used to make synthetic marijuana. But 18 variants of the drug have since surfaced, and, Chiesa said, the change in ingredients may have led to new side effects.

"What happens is they tweak it a little bit, and it’s not like they’re testing it, it’s not like the FDA gets involved and does clinical trials," he said.

Most of the raw compounds come from other countries, making it even more difficult to control the drug’s spread, said Mark Ryan, a national expert on designer drugs.

"They are getting the base compounds for the most part out of China," said Ryan, director of the Louisiana Poison Control Center. "If you’ve got a chemist or a lab that knows what they’re doing, they literally can be creating new compounds every day."

The order will remain in effect for 270 days, but will require action from the state legislature after that, Chiesa said. Anyone in possession of synthetic marijuana must surrender the chemicals within 10 days, or face a drug possession charge punishable by up to five years in prison.

Following similar bans in three other states, Calcagni said, the order will help New Jersey "get ahead of the clever manufacturers and those backyard, basement chemists, and to stay ahead of them."

But Ryan warned that users and street dealers will move to newer chemicals and even new classes of drugs in search of their next legal high.

Related coverage:


N.J. police target dangers of synthetic marijuana being marketed as legal alternatives to pot


DEA bans K2 synthetic marijuana sold as incense


Complete coverage of the New Jersey medical marijuana legislation


Marijuana-crazed teen runs from Clinton Twp. home in pajamas, barefoot, prompting widespread search, police report


Easing of N.J. medical marijuana rules stalls in Senate from lack of support


Proposed medical marijuana rules again face scrutiny from N.J. lawmakers


N.J. doctors required to 'make reasonable efforts' to wean patients off medical marijuana




29.02.2012 19:01:33


EssayContest_1.jpg




Finalists to Participate in National Geographic’s Photo Camp on Cape Eleuthera




The United States Embassy in partnership with the Bahamas National Drug Council (BNDC is pleased to announce the launch of the first “Youth Express” Essay, Rap and Poetry Competition. The purpose of the contest is to encourage students throughout The Bahamas to consider the harmful impact of illegal drugs and to reflect on how they can resist negative peer pressure and act as leaders against drugs in their community.  This exciting program is part of a continuing partnership between the US Embassy, the Bahamas National Drug Council and the National Anti-Drug Secretariat to reduce the demand for illegal drugs and foster ...





29.02.2012 23:24:00

By Peter Loftus 
   Of DOW JONES NEWSWIRES

A U.S. judge has approved a legal settlement that requires Merck & Co.'s (MRK drug research arm to inform the company's board of directors of delays in reporting clinical trial results.

The settlement ends part of the litigation that followed the 2008 release of results of the "Enhance" clinical trial of Merck's cholesterol drug Vytorin, which raised questions about its efficacy, nearly two years after the study was completed in 2006. The data caused Vytorin sales to decline.

Merck and its cholesterol-drug partner at the time, Schering-Plough, were accused of delaying the release of the Enhance trial results to protect solid sales growth for Vytorin and a related drug, Zetia. The companies, which merged in 2009, said the delay was needed to analyze issues with data quality.

A shareholder derivative lawsuit was filed in federal court in New Jersey in 2008 against Schering and certain officers and directors, including its former chief executive, Fred Hassan, alleging the defendants withheld the Enhance results and made false and misleading statements about the study. Merck subsequently became a party to the lawsuit.

In December 2011, the parties agreed to a settlement that would terminate the litigation.

Under the terms of the settlement, Merck Research Laboratories will provide an annual report to the research committee of Merck's board, describing any clinical trials with results that haven't been reported within 12 months of completion, including the reasons for the delay and any corrective action taken.

The clinical trials subject to this policy are for Merck-sponsored studies of products marketed in the U.S., for which Merck is required to register and post results under federal law. The policy doesn't cover experimental drugs that aren't yet on the market.

Merck will retain this change in its corporate governance for at least three years, unless a majority of the independent directors deem it no longer in the best interest of Merck.

The settlement doesn't require Merck to make any monetary payments beyond attorneys' fees and expenses of no more than $5.1 million.

U.S. District Judge Dennis Cavanaugh approved the settlement Tuesday.

"We feel the settlement is an appropriate resolution of the case," said Merck spokesman Ron Rogers. He added that Merck has made no admission of wrongdoing or liability.

An attorney for the plaintiffs couldn't immediately be reached.

Merck has previously settled other lawsuits related to the Enhance trial, though some litigation continues.

Merck shares declined 2 cents to $38.36 in recent trading.

-By Peter Loftus, Dow Jones Newswires; +1-215-982-5581;
peter.loftus@dowjones.com

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28.02.2012 23:47:55
Melanie Poole

The emergence of 'Labor for Life', a group of Labor MPs, members and supporters who have mobilised to oppose abortion, among other issues, should deeply concern Australians who care about human rights and saving lives.

Members of 'Labor for Life', along with 'pro-life' Coalition MPs, have been key opponents of efforts to achieve reproductive choice for women in both Australia and developing countries.

As one example, MPs in both major parties have supported a ban on using Australian aid funding for a range of sexual and reproductive health services, including safe and legal abortion. In place from 1996-2009, the recent lifting of these restrictions has been a continued rallying call for anti-abortion campaigners from both major parties.

Anti-abortion campaigning prevents access to safe, legal abortion, which only increases the prevalence of unsafe, and deadly, abortion. Abortion is among the safest medical procedures in the world when conducted by trained professionals. But when skilled care is unavailable, as in many developing countries, abortion endangers women's lives.

Labelled by the World Health Organisation as the world's greatest 'preventable pandemic', unsafe abortion kills one woman every eight minutes, 99 per cent of these deaths occurring in developing countries. Globally, pregnancy is the greatest killer of girls aged 15-19, and, for girls aged 12-25, unsafe abortion is among the greatest – and most easily preventable – causes of maternal death.

These girls and young women die when, because of a mixture of legal restrictions, resource shortages and gender discrimination, they are forced to seek out untrained practitioners. Common methods include swallowing bleach or toxic levels of anti-malarial drugs or inserting sharp objects, such as sticks or wire, into the uterus to induce bleeding, often resulting in fatal infections. Women sometimes also risk serious physical injury.

In a case currently before the UN's Committee On The Elimination Of Discrimination Against Women, 'L.C', a 13-year-old Peruvian girl, was raped by an older man. Pregnant and denied access to abortion, L.C jumped from a rooftop. She is now a quadriplegic.

Despite the enormous risk involved in seeking an unsafe abortion, for some young girls it is the safest in a limited range of choices. In some developing countries, a girl has a higher chance of dying in childbirth than she does of attending school. Often forcibly impregnated as the result of sexual violence, young girls without access to safe medical care have up to a one in five chance of dying if they are forced to continue the pregnancy. A pregnancy often also guarantees an end to their schooling and consequently to even the most basic aspirations they may have for their lives. Their chances of ending up permanently disabled, for example by suffering from obstetric fistula, and the extreme stigma and rejection that follows, are high – as are the chances that they will deliver stillborn or extremely premature infants.

Who are we, privileged Australians whose own reproductive choice is protected, to judge the complex and unavoidable decisions that young girls and women across the world have to make? Have the ironically named 'Labor for Life' members really considered the human cost of opposing funding for safe and legal abortion in impoverished countries?

Unsafe abortion kills almost 70,000 women and girls every year. Millions more are permanently injured. Their lives would be saved, and the number of abortions would dramatically plummet, if contraception was made widely available and restrictive laws were removed.

Women access abortion for diverse, complex reasons. To do so is their human right, affirmed by multiple UN Committees including those who interpret Human Rights, the Rights of the Child, Economic, Social and Cultural Rights and the Convention Against Torture.

People are entitled to their private views about when life begins, but forcing those views onto others, and denying recognised human rights in the process, demonstrates a serious lack of empathy for the difficult choices that women face. It is also naive: regardless of legal restrictions, when women find themselves confronted with the extreme stress of an unwanted pregnancy they may seek whatever means possible to end it. For Alice, a 17-year-old who I knew while working at a refugee camp in Kenya, death was a less frightening prospect than bearing the child of the man who killed her father and raped her. Let those who would seek to end Australia's support for safe abortion cast their first stone at her.

Removing choice from teenage girls like Alice does not reduce abortions. The number of abortions performed in countries where abortion is illegal is actually higher than the number in countries where it is legal.

The reality is that anti-abortion campaigning does not save lives. What it does do is promote unsafe abortion. What it means is that desperate girls and women will continue to die, needlessly, every year. And after they die many of their orphaned children do too.

Australia has finally joined global efforts to make abortions rare, legal and safe.

Now that is a pro-life cause.

Melanie Poole is the Parliamentary Advocacy Coordinator at CARE Australia. The views expressed are her own. View her full profile
here.




01.03.2012 21:52:09

Three bellwether trials against drug manufacturer Merck & Co. are scheduled to take place this year. Opening statements for two consolidated
Fosamax lawsuits are expected to begin today in the New Jersey state court.

Two women, Jo Ann Sessner and Ameila Flores, claim they developed osteonecrosis of the jaw (ONJ after taking Fosamax. Osteonecrosis is a painful condition which causes the jaw bone to decay requiring surgery to remove portions of it.

Merck maintains that Fosamax did not cause Sessner and Flores to suffer jaw injuries. According to a statement released by the company’s legal counsel, “Unfortunately, both plaintiffs had medical problems that cause people to develop jaw problems regardless of whether they were taking Fosamax.”

Fosamax was introduced by Merck and approved by the Food and Drug Administration in October 1995 for the treatment of osteoporosis, a chronic condition which causes bones to become brittle and weak leading to possible breakage. It is included in a class of bone strengthening medications known as bisphosphonates. Prior to the release of a generic, Fosamax generated more than $3 billion in 2010.

An increased number of reported problems associated with bisphosphonate drugs such as Fosamax, Boniva®, and Reclast® caused the Food and Drug Administration to issue a bisphosphonate warning and later require manufacturers to update warning labels.

Currently Merck faces more than 1,000 Fosamax side effects lawsuits filed by women who have taken Fosamax for the treatment of osteoporosis. The lawsuits allege that Fosamax causes adverse side effects such as osteonecrosis of the jaw and atypical
femur fracture injuries when taken for long periods of time, usually 12 months or more.

All
femur fracture lawsuits have been consolidated in the U.S. District Court for the District of New Jersey while jaw decay lawsuits have been consolidated in the U.S. District Court for the Southern District of New York.

http://consumer-drug-report.com/content/fosamax-jaw-decay-lawsuits-opening-statements-be-heard#comments



29.02.2012 16:17:25

Campaigners have warned of a ‘disaster waiting to happen’ over a potentially harmful drug found in leaves that are on sale legally.

When chewed, Khat leaves produce a stimulant effect. It is widely used among Manchester’s Somali community.




2012-03-01 10:10:56
US District Judge Richard Leon sided with tobacco companies on Wednesday, ruling that regulations requiring large graphic health warnings on cigarette packaging and advertising violate free speech rights under the US Constitution, reports Wendy Koch for USA Today. Leon continued, writing that the requirement would “violate the First Amendment by unconstitutionally compelling speech.” The decision conflicts with a January 2010 ruling by US District Court Judge Joseph McKinley, that upheld the labels’ legality and is expected to end up at the steps of the US Supreme Court for a final decision. In 2009, Congress gave authority to the Food and Drug Administration (FDA to regulate tobacco and approved nine graphic warnings that tobacco makers could rotate on cigarette packs beginning in September. The tobacco products images would include prominent images of rotting teeth, diseased lungs and a corpse with chest staples on an autopsy table. The images, which would cover the top half of the front and back of each pack. In the 19-page ruling, Judge Leon argued that, while educating the public about the dangers of smoking, “might be compelling, an interest in simply advocating that the public not purchase a legal product is not.” Further, Leon said the government has numerous other tools at its disposal to deter smoking such as raising cigarette taxes or including simple factual information on the labels rather than gruesome images, Jeremy Pelofsky reported for Reuters. Matthew Myers of the Campaign for Tobacco-Free Kids said Leon’s ruling that the “graphic images are neither factual nor accurate” is “incomprehensible,” arguing that smoking causes fatal lung disease, cancer and heart disease. Reynolds American Inc’s R.J. Reynolds unit, Lorillard Inc, Liggett Group, Commonwealth Brands, which is owned by Britain’s Imperial Tobacco Group, and Santa Fe Natural Tobacco challenged the rule, arguing it would force them to engage in anti-smoking advocacy against their own legal products. “We believe governments, public health officials, tobacco manufacturers and others share a responsibility to provide tobacco consumers with accurate information about the various health risks associated with smoking,” said Martin Holton, general counsel for R.J. Reynolds. “However, the goal of informing the public about the risks of tobacco use can and should be accomplished consistent with the US Constitution,” Holton added in a company statement. --- On the Net:



01.03.2012 1:42:00

The state of abortion access in Canada

Features

Sarah Vitet — Capilano Courier (Capilano University

VANCOUVER, B.C. (CUP — In 1988, Dr. Henry Morgentaler challenged Canada’s abortion regulations in the Supreme Court of Canada, where they were struck down and found to be in violation of the Canadian Charter of Rights and Freedoms.

A year later, another case was brought to the Supreme Court in regards to fetal rights, after a man tried to get an injunction so that his ex-girlfriend could not have an abortion (Tremblay v. Daigle . The final ruling declared that a fetus has no legal status in Canada as a person, both in Canadian common law and Quebec civil law.

Since then, Canada has had no laws regulating abortion access. However, there continue to be multiple barriers for Canadian women faced with unwanted pregnancies, including societal perceptions and stigma and lack of access in rural and remote areas.

Access denied

In Prince Edward Island, the government does not provide any abortions at all on the island.

“P.E.I. does send some women to Halifax,” explains Joyce Arthur, executive director of the Abortion Rights Coalition of Canada. “They will pay for their abortion in Halifax, but it’s an onerous process for women to go through. Confidentiality is lost because of the paperwork, and they have to get approval from a doctor there, which adds to the delay.”

Women are required to travel off-island at their own expense, and the only other option for women facing an unwanted pregnancy in P.E.I. is to travel to the clinic in Fredericton and pay around $800 for the procedure. “So [abortion is] really just an option for women who can afford it,” says Arthur. “Which is discriminatory, because young women, or low-income women, can’t even afford to get off the island.”

The P.E.I government will only fund abortions that happen in a hospital, not a clinic, and the woman must have a referral from two doctors. In 2011, only 49 women from P.E.I. received an abortion at the hospital in Halifax, while 73 women went to the clinic in Fredericton and paid for the procedure themselves.

According to Arthur, this has resulted in women attempting self-administered abortions in P.E.I. Psychologist Colleen MacQuarrie,
as reported by the CBC, conducted interviews with women in PEI regarding abortion. She recalls talking to a “14-year-old who found herself pregnant and was desperate to not even tell anyone she was pregnant, and so engaged in two weeks of intense self-harm, ingesting different chemicals, just doing anything she could to bring on a period.”

The Health Minister in P.E.I., Doug Currie, says the status quo is acceptable and abortions are just one of a number of health services that the Island has chosen not to perform in order to save resources. "To me, it’s not about the political discussion, it’s more about another service," he
told the Charlottetown Guardian.

Arthur argues that this is a weak excuse and notes that all hospitals have the equipment to perform a miscarriage and other standard procedures. “So, it’s all set up and ready to go, they can do abortions. It’s a bad excuse, except they don’t have a doctor there to do it. The anti-choice movement in P.E.I is strong, and no doctor there is going to do abortions because of the harassment they would get,” says Arthur.

There are reportedly eight obstetricians in P.E.I., a profession in which abortion training is part of their instruction; however, the government claims that no doctor has ever applied for privileges to perform abortions on the Island and been refused.

“Keeping P.E.I. ‘Canada’s Own Life Sanctuary,’”
reads an advertisement by the Right to Life Association in P.E.I. The organization is one of many groups who disagree that abortion should be made available on the Island.

“We certainly made it clear to the minister that we’re really just beginning our campaign,” association spokeswoman Anne Marie Tomlins
told the
National Post
. “It’ll get as big as it has to get to make things go away.”

With no intention of implicating the Right to Life Association, it is worth mentioning that doctors do have reason to be nervous when deciding whether to become an abortion provider or not: Dr. Garson Romalis, a provider from Vancouver, was shot and seriously wounded in 1994, and then attacked again and stabbed in 2000; the Toronto Morgentaler clinic was fire-bombed in 1992; and two other Canadian doctors were shot between 1995–97.

Globally, abortion providers have been the victims of escalating acts of violence, including harassment, stalking and kidnapping, and even arson and murder. In the United States, the Christian terrorist anti-abortion group, called Army of God, are responsible for many of the above-mentioned acts, as well as bombings, the assassination of providers and anthrax threats.

Stigma and distance

Prince Edward Island is not the only province limiting abortion access. A 2003 study by the Canadian Abortion Rights Access League found that fewer than one in five Canadian hospitals provide abortion services, nationally, and those hospitals are located only in larger communities.

New Brunswick, like P.E.I., does not fund abortions unless they are performed at a hospital. As there are only two hospitals that can perform abortions in N.B., the demand is higher than can be met, so the rest of the abortions are performed at the unfunded Morgentaler clinic in Fredericton. This means women must pay for the procedure themselves.

The preliminary findings of a federally-funded study by Christabelle Sethna and Marion Doull indicated that “nearly 23 per cent of women who have obtained abortions in a freestanding clinic had to pay for it up front; 15 per cent travelled more than 100 kilometres from home.” Clinics perform roughly 45 per cent of all abortions in Canada.

Manitoba did not fund abortions done at clinics until 2004, when a non-profit clinic successfully sued the provincial government to pay for abortion procedures. Quebec had similar restrictions, but in 2008 ruled that all abortions would be funded, without any limitations. In the Yukon, the Northwest Territories, and Nunavut, abortions are accessible only in the capital cities, but the territorial governments do pay travel costs for women from remote areas.

Although access in B.C. is better than in other provinces, the public stigma regarding abortion continues to make the process difficult, and services are still limited to larger communities.

When Mary Scott tried to get an abortion in Penticton, B.C., she faced both geographical and societal barriers: “There’s no actual place in Penticton to get one [an abortion], so if you lived in Penticton, Summerland, etc., you had to go out to the one clinic in Kelowna," Scott explains. Penticton is a one-hour drive from Kelowna. "They only do abortions on Tuesdays and are incredibly hard to get a hold of."

Kelowna is well-known for being a community with active anti-abortion groups. As reported in the
Globe and Mail
, “protesters stage weekly vigils outside the Kelowna General Hospital, [and] a doctor has to be flown in from Vancouver to perform abortions.”

Scott says that due to protesters, the clinic did not have an answering machine, and every time she went past the clinic she was yelled at and called “a murderer.” When she went in for her ultrasound, Scott says that the nurse told her she was “wasting taxpayer dollars,” and she was given very little advice or guidance.

Globally

While Stephen Harper
has been popularly quoted as saying, “As long as I’m Prime Minister, we are not reopening the abortion debate,” Conservative backbenchers continue discussing the issue in the media, and in the past have brought forward private member’s bills in attempts to give personhood rights to fetuses, or ban coercion to have an abortion.

In April 2011, the federal government denied funding to the International Planned Parenthood Federation (IPPF , which had applied for an $18 million grant. Later in the year, the Canadian International Development Agency did grant IPPF with a $6 million grant over three years. The renewed funding has been criticized by anti-choice advocates such as Conservative MP Brad Trost,
who said that IPPF should not receive federal funding due to its support for abortion.

IPPF is an organization that promotes and advocates sexual and reproductive health and freedom internationally, as well as provides information and education, promotes access to services, and campaigns in order to improve legislation and remove barriers to services. Their website says they do provide "safe abortion services," including providing qualified practitioners in clean conditions.

The CIDA funding for IPPF is to go towards services in Afghanistan, Bangladesh, Mali, Sudan, and Tanzania.

In 2001, the United States, under then-president George Bush, reinstated a policy which prohibited funding to non-governmental organizations performing or promoting abortion. Once the policy took effect, the rates of induced abortion rose in sub-Saharan Africa, leading researchers to speculate over the connection. A study done at Stanford University in 2011 concluded that “reduced financial support for family planning may have led women to substitute abortion for contraception.”

A 2007 World Health Organization study indicated that 67,000 women die each year due to complications from unsafe abortions, primarily in countries where abortion is not permitted under the law.

Medically necessary

John Hof is the president of the Campaign Life Coalition of British Columbia, which he describes as “the political activist arm of the pro-life movement in B.C.” The CLC puts on various campaigns both nationally and in individual provinces, including the 40 Days for Life campaign, the Defund Abortion Rally, and the Pro-Life day of Silent Solidarity.

“Planned Parenthood,” says Hof, “should not receive a penny of federal funding.”

One of the goals that Hof and the CLC are working toward includes “defunding of abortion from the medical services plan.” However, this has been attempted previously, with little success.

In 1995, under pressure from the Committee to End Taxpayer-Funded Abortions, the Alberta government attempted to define “medically required” abortions as versus those that are not medically necessary in an effort to fund only those deemed required. The Alberta Medical Association and the College of Physicians and Surgeons were asked to clarify the distinction, but they refused.

“You have to leave it up to the doctor to decide, based on the patient’s best interest,” says Arthur. “We can’t distinguish between different types of abortion as to whether they are medically necessary or not, because that would require women having to state their reason and then someone having to decide whether their reasons are legitimate or not, and it just won’t work. You can’t have decisions being made around women’s health that are not related to what the woman needs herself.”

Arthur also notes that not funding abortion would be discriminatory, as women who are well-off could easily get an abortion, “but it’s the poor women and the disadvantaged women who are stuck, and that’s unjust,” she says.

The ARCC also emphasizes that defunding abortion or imposing restrictions would be a violation of women’s rights to life, liberty and security of person under the Charter of Rights and Freedoms.

“Abortion must be funded because it is not an elective procedure, any more than childbirth is,” Arthur writes. “Pregnancy outcomes are inescapable, meaning that a pregnant woman cannot simply cancel the outcome — once she is pregnant, she must decide to either give birth or have an abortion. To protect her health and rights, both outcomes need to be recognized as medically necessary and fully funded, on an equal basis.” This echoes the sentiment expressed by the Morgentaler Clinic, “Every mother a willing mother.”

According to Hof, “Eliminating the child should never be suggested as a solution with total disregard for subsequent effects on the mother and the child.” He believes that “in a civilized society it [abortion] should not be tolerated.”

In a 2010 online Angus Reid poll, 39 per cent of respondents responded positively to the statement, “The health care system should only fund abortions in the event of medical emergencies.” Another poll reported that 27 per cent of Canadians describe themselves as “pro-life.”

However, the ARCC warns that popular opinion polls are not a good way to make decisions regarding women’s health. “Voter opinion on this issue has been shaped by anti-choice misinformation, as well as lingering prejudice about women who have abortions,” they say.

Arthur also explains that 90 per cent of abortions happen by 12 weeks, the other eight per cent happen by 16 weeks, and one to two per cent are done by 20 weeks. Only roughly 0.3 per cent of abortions happen after 20 weeks, and in those cases there are major complications, such as serious fetal abnormalities, or extremely young women who were unaware of their condition.

“Late-term abortions are the ones that are the most desperately needed of all, done for medical reasons, and so it’s ridiculous to criminalize those,” says Arthur. “The idea of criminalizing abortion would just be from the myth of women having a lot of abortions, but that doesn’t happen,” she says.

Coercive forces

Hof explains that another goal of the CLC is to ensure “protection for women being coerced into abortion.”

In 2010, Bill C-510 was put forward in order to amend the Criminal Code, and would make it illegal to coerce a woman into having an abortion. It was put forward by Conservative MP Rod Bruinooge and was not supported by Stephen Harper. Threats and illegal acts, such as coercion, were already illegal under the Criminal Code, and the bill did not turn into law; but it did spark conversation in regards to various influences over women’s fertility.

A 2010 study by the Guttmacher Institute found that women in abusive relationships were often coerced into childbirth: “Pregnancy promotion involves male partner attempts to impregnate a woman, including verbal threats about getting her pregnant, unprotected forced sex, and contraceptive sabotage,” the study read. Seventy-four per cent of respondents reported experiencing this kind of coercion.

The concern over coercion in regards to pregnancy and abortion is evident from both pro-choice as well as anti-choice groups. Crisis pregnancy centres such as Birthright International advertise that they are “here to help you in making a decision about your pregnancy,” but critics suggest that they are misleading, and exist in order to coerce women out of having abortions.

“I have nothing against anti-choice places if they want to help women … [and] give them resources and support to have their babies,” says Arthur. “The problem with these hotlines and these crisis pregnancy centres is that they are very deceptive. You see, all the advertising [says], and they say, they will help you with all your options … but in fact, that’s not what they get … They engage in all the standard misinformation tactics, and scare them [women] and confuse them with really unprofessional counseling techniques.”

Prevention

A 2010 report by the Sex Information and Education Council of Canada showed that there has been a 36.9 per cent decline in Canada’s teen birth and abortion rate between 1996 and 2006, owing to an increase in contraception and birth control use.

In Canada, however, the Medical Services Plan does not universally fund birth control or contraceptives, though there are advocates that say they should.

In the United States, the Obama administration announced that all health insurance plans must cover birth control as preventative care for women, as it is also more cost-effective than dealing with unwanted pregnancies and births. Many Conservative and Republican leaders have spoken out against the requirements, although they do not officially come into effect until 2013.

Globally, countries with the best access to contraceptives and sex education have the lowest abortion rates. The Netherlands, for example, have one of the lowest abortion rates in the world, and they have fully funded birth control, as do many other European countries with similarly low abortion and teen pregnancy rates.

In regards to the Canadian government funding birth control, Hof does not believe we should add more costs to the health care system. “Birth control and contraception are life style choices. In no other situation do we facilitate choices by financially supporting them with tax dollars,” says Hof. “We don’t buy people cigarettes if they choose to smoke. We don’t use tax dollars to enable people who choose to do drugs to do so. The suggestion that people’s choice to use birth control should be paid for with tax dollars is wrong on so many levels,” he says.

However, Arthur counters that we give people free health care, regardless of why they need it, including smokers with lung cancer and people with addiction: “Ninety-eight per cent of women have used contraception at some point,” she says. “The main cause of abortion is unattended pregnancy, and the main cause of unattended pregnancy is no use or improper use of contraception.

"Women still have to pay for that, in most cases, and it’s expensive," she said. "Contraception is essential preventive health care for women — and all of society.”

-30-




29.02.2012 18:24:18

Orthopedics device maker Globus Medical and its CEO agree to pay a $1 million fine after an FDA inspection finds the company marketing bone graft products that the agency had denied for the U.S. market.

Globus Medical logo

Orthopedics device maker Globus Medical will pay $1 million, including a fine for its chief officer, to settle FDA charges that the company marketed bone graft products without getting the agency's approval.

The fine includes $550,000 in penalties and a $450,000 charge for Globus CEO David Paul.



read more

http://www.massdevice.com/news/fda-fines-globus-medical-and-ceo-1m-selling-rejected-bone-graft-products#comments



01.03.2012 11:00:00
A study led by Case Western Reserve University School of Medicine, in collaboration with the University of East London UK, and Swansea University UK, is the first to show the effects of the drug ecstasy on fetal and infant development. Ecstasy is a stimulant and hallucinogen, and is one of the most widely used illegal drugs among young people, with a range of damaging effects...



mrothschild@foodsafetynews.com (Mary Rothschild
29.02.2012 12:59:06
Late last year, Interpol-Europol agents seized hundreds of tons of counterfeit, fake and substandard food and beverages, including champagne, cheese, olive oil and tea, across 10 countries in Europe.
During Operation Opson (opson translates to "food" in ancient Greek , authorities confiscated more than 13,000 bottles of substandard olive oil, 30 tons of fake tomato sauce, about 77,000 kg. of counterfeit cheese, more than 12,000 bottles of substandard wine, five tons of substandard fish and seafood, nearly 30,000 counterfeit candy bars and investigated fake/substandard caviar being sold via the Internet.  
The one-week effort (from November 28 to December 4 involved police, customs agents, regulatory and food-industry officials in airports, seaports, shops and flea markets in Bulgaria, Denmark, France, Hungary, Italy, The Netherlands, Romania, Spain, Turkey and the United Kingdom.
At the time, Simone Di Meo, Criminal Intelligence Officer with Interpol's Intellectual Property Rights program and coordinator for Operation Opson,
said in a news release that counterfeit food is a threat most people are not even aware of, so "one of the main goals of this operation was to protect the public from potentially dangerous fake and substandard food and drinks."

This week in Brussels, food control authorities, police forces, judicial officials and other stakeholders from across the European Union met again to develop strategies for combating food-related crime -- to understand the nature of food counterfeit schemes, to improve detection of these illegal practices and to raise public awareness of the problem to prompt vigilance when shopping.
The conference, held Monday and Tuesday, was part of the EU's Better Training for Safer Food program.
Consumers buying counterfeit goods, either knowingly or unknowingly according to European authorities, put their health at risk because fraudulent foods and beverages are not subject to any manufacturing quality controls and are often transported or stored without regard to safe food-handling standards. 
The problem of counterfeit and substandard products is also a concern in the United States, most visible with fake pharmaceuticals, but also with food items. Cheaper types of fish have been passed off as more expensive, such as tilapia being marketed as red snapper or farm-raised salmon being labeled as wild-caught.
According to the U.S. Food and Drug Administration, olive oil is one of the most frequently counterfeited food products -- it is sometimes sold as "extra virgin" when it is actually mostly soybean oil.  Honey, maple syrup and vanilla counterfeits have also plagued the U.S. market.
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Photo from Interpol-Europol
 

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