Thursday, March 1, 2012

News and Events - 02 Mar 2012




29.02.2012 0:58:00

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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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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.




NHS Choices
29.02.2012 21:00:00

Patients with a common type of metal hip implant should have annual health checks for as long as they have the implant, according to the UK body for regulating medical devices. The all-metal devices have been found to wear down at an accelerated rate in some patients, potentially causing damage and deterioration in the bone and tissue around the hip. There are also concerns that they could leak traces of metal into the bloodstream, which the annual medical checks will monitor.

Hours before critical coverage from the British Medical Journal and the BBC, the Medicines and Healthcare products Regulatory Agency (MHRA issued new guidelines on larger forms of ‘metal-on-metal’ (MoM hip implants. Advice on smaller metal devices or those featuring a plastic or ceramic head has not changed. Previously, guidelines suggested larger MoM implants should only be checked annually for five years after surgery. The agency now says the annual check-ups should be continued for the life of the implant. Check-ups, they say, are a precautionary measure to reduce the “small risk” of complications and the need for further surgery.

Together with the recent controversy over PIP breast implants, the news has caused some medical quarters to call for tighter regulation of medical devices, perhaps bringing the approval process into line with that of medicines, which must undergo several years of laboratory, animal and human testing before being approved for wider use.

What types of implants are involved?

There are numerous designs and materials used to make hip implants. In recent days the MHRA has issued major updates to its advice on a type of metal-on-metal (MoM hip replacement. As the name implies, MoM implants feature a joint made of two metal surfaces – a metal ‘ball’ that replaces the ball found at the top of the thigh bone (femur and a metal ‘cup’ that acts like the socket found in the pelvis.

The MHRA’s updated advice concerns the type of MoM implant in which the head of the femur is 36mm or greater. This is often referred to as a ‘large head’ implant. The agency now says that patients fitted with this type of implant should be monitored annually for the life of the implant, and that they should also have tests to measure levels of metal particles (ions in their blood. Patients with these implants who have symptoms should also have MRI or ultrasound scans, and patients without symptoms should have a scan if their blood levels of metal ions are rising. The previous guidance on this type of hip implant, issued in April 2010, advised that patients should be monitored annually for no fewer than five years.

What about other types of hip implants?

Advice on monitoring patients with other types of hip implants remains the same, and guidance has not changed on:

  • MoM hip resurfacing implants – where the socket and ball of the hip bone has a metal surface applied to it rather than being totally replaced.
  • Total MoM implants where the replacement ball is less than 36mm wide.
  • A particular range of hip replacements called DePuy ASR – these hip replacements were recalled by their manufacturer, DePuy, in 2010 because of high failure rates. The company made three types of ASR implant.
  • Implants featuring plastic or ceramic heads.

How many people are affected?

It is estimated that, in total, 49,000 people in the UK have been given metal-on-metal implants with a width of 36mm or above. This represents a minority of the patients given hip replacements, who mostly have devices featuring plastic, ceramics or smaller metal heads.

In 2010 there were 68,907 new hip replacements fitted, and approximately 1,300 of these surgeries used an MoM implant sized 36mm or above – a rate of around 2%.

What exactly is the problem with MoM implants?

All hip implants will wear down over time as the ball and cup slide against each other during walking and running. Although many people live the rest of their lives without needing their implant to be replaced, any implant may eventually need surgery to remove or replace its components. Surgery to remove or replace part of the implant is known as ‘revision’ and, of the 76,759 procedures performed in 2010, some 7,852 were revision surgeries.

However, data now suggest that large head MoM hip implants (those with a width of 36mm or greater wear down at a faster rate than other types of implants. As friction acts upon their surfaces it can cause tiny metal particles (medically referred to as ‘debris’ to break off and enter the space around the implant. Individuals are thought to react differently to the presence of these metal particles, but, in some people, they can trigger inflammation and discomfort in the area around the implant. Over time this can cause damage and deterioration in the bone and tissue surrounding the implant and joint. This, in turn, may cause the implant to become loose and cause painful symptoms, meaning that further surgery is required.

News coverage has also focused on the MHRA’s recommendation to check for the presence of metal ions in the bloodstream, potentially released either from debris or the implant itself. Ions are electrically charged molecules. Levels of ions in the bloodstream, particularly of the cobalt and chromium used in the surface of the implants, may, therefore, indicate how much wear there is to the artificial hip.

There has been no definitive link between ions from MoM implants and illness, although there has been a small number of cases in which high levels of metal ions in the bloodstream have been associated with symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system and thyroid gland.

The MHRA points out that most patients with MoM implants have well functioning hips and are thought to be at low risk of developing serious problems. However, a small number of patients with these hip implants develop soft tissue reactions to the debris associated with some MoM implants.

How are medical devices regulated?

In the UK, the MHRA is the government agency responsible for ensuring that medical devices work and are safe. The MHRA audits the performance of private sector organisations (called notified bodies that assess and approve medical devices. Once a product is on the market and in use, the MHRA has a system for receiving reports of problems with these products, and will issue warnings if these problems are confirmed through their investigations. It also inspects companies that manufacture products to ensure they comply with regulations.

This system differs greatly from that for testing and approving drugs. Drugs require several years of research testing and trials before they can be approved for clinical use.

What action have regulators taken?

The MHRA has convened an expert advisory group to look at the problems associated with MoM implants. This meets regularly to assess new scientific evidence and reports from doctors and medical staff treating patients. The agency says it is continuing to monitor closely all the latest evidence about these devices and may issue further advice in the future.

In the US, the Food and Drug Administration (FDA says it is gathering additional information about adverse events in patients with MoM implants. In the meantime, it advises patients with MoM hip implants who have no symptoms to attend follow-up appointments as normal with their surgeon. Patients who develop symptoms should see their surgeon promptly for further evaluation.

What actions have critics called for?

In light of the PIP breast implant controversy and this new information on hip implants, there is currently intense scrutiny on the way medical devices are regulated in the UK and Europe, with patient groups and the media arguing that medical devices should be regulated in a similar way to medicines.

Clearing a medicine for use in the UK is a lengthy process involving several stages of laboratory and animal testing, and then carefully controlled and monitored tests in humans. Only once there is enough evidence to suggest that a medicine is reasonably safe can it enter clinical use, and even then patients will be monitored to look at the longer-term effects of the drug.

However, medical devices are not required to go through human trials before entering use, and can currently be approved on the basis of mechanical tests and animal research. While certain devices, such as hip implants, have been monitored through systems such as the National Joint Registry, in light of the recent health concerns over PIP breast implants, patient groups are calling for more testing before devices are allowed into clinical use, and closer mandatory monitoring schemes to ensure their safety once they enter the market.

Links To The Headlines

Annual blood tests for hip patients over poison fears. The Daily Telegraph, February 29 2012

Hip replacement toxic risk could affect 50,000. The Independent, February 29 2012

MHRA: Metal hip implant patients need life-long checks. BBC News, February 29 2012

Metal scare over hip replacement joints. The Guardian, February 29 2012

Toxic metal hip implants 'could affect thousands more people than PIP breast scandal. Daily Mail, February 29 2012




2012-02-28 11:03:43
A new study finds that people who take certain commonly prescribed sleeping pills have a five-fold increased risk of death, even among those taking fewer than 18 doses a year. And these drugs are also linked to a significantly increased risk of cancer among those taking high doses, the study, published in the journal BMJ Open, shows. The study, analyzing 10,500 people who took a wide-range of sleeping pills including zolpidem, diazepam and tamazepam, found that the top third of sleeping pill users had a 5.3-fold higher death risk and also had a 35 percent higher risk of cancer. And people who were on higher doses of tamazepam were six times as likely to die in the next 30 months, the study found. “We are not certain. But it looks like sleeping pills could be as risky as smoking cigarettes. It looks much more dangerous to take these pills than to treat insomnia another way,” study leader Daniel F. Kripke, MD, told WebMD. The sleeping pills in question are known as hypnotics and include such brands as Ambien and Restoril. Hypnotic sleeping pills actually cause a person to fall asleep. This is in contrast to other sleeping aids, such as melatonin, which promote sleep through relaxation. Kripke and colleagues said other dangerous hypnotic sleeping aids include Lunesta, Sonata, Halcion, and Dalmane. Kripke, retired professor of psychiatry at the University of California, San Diego, began studying the effects sleeping pills have on the risk of death in 1975. Since then, he has co-published 18 studies finding links between the two. In the latest study, Kripke and colleagues analyzed data from a large Pennsylvania health system from between 2002 and 2007. They obtained medical records for 10,529 people who used prescribed hypnotic sleeping pills and for 23,676 matched patients who were never prescribed sleeping pills. Over an average of 2.5 years, the death rate for those who did not use sleeping pills was 1.2 percent. For those who were prescribed sleeping pills the death rate climbed to 6.1 percent. And after taking into account factors likely to influence the results - including age, sex, weight, lifestyle, ethnicity and previously diagnosed cancer - the study’s results pointed to a 3.6-fold higher death rate in those who only took 18 or fewer doses. Based on their findings, Kripke and colleagues estimate that sleeping pills are linked to between 320,000 and 507,000 US deaths each year. “We think these sleeping pills are very dangerous. We think they cause death. We think they cause cancers,” said Kripke. “It is possible but not proven that reducing the use of these pills would lower the U.S. death rate.” The associations of increased death risk was found in every age group, but were greatest among those aged 18 to 55. Supplemental material published alongside the paper showed that, although the overall numbers of deaths in each group were quite small, there were clear differences among them. For example, there were 265 deaths among 4,336 people taking zolpidem, compared with 295 deaths among the 23,671 people who had not taken sedatives or sleeping pills. Kripke pointed out that studies showing association do not necessarily prove cause and effect, however. But the findings do back up previous research showing an increased risk of death among sleeping pill users, he added. “The meager benefits of hypnotics [sleeping pills], as critically reviewed by groups without financial interest, would not justify substantial risks,” wrote Kripke. “A consensus is developing that cognitive-behavioral therapy of chronic insomnia may be more successful than hypnotics.” Sleeping pills are thought to also increase risk of depression and can impair driving skills. Kripke has passed the study findings on to the US Food and Drug Administration (FDA , the watchdog to the US pharmaceutical industry. The authors of the study said their findings, together with similar findings in previous studies, should be used by authorities to re-assess whether even modest doses of sleeping pills are safe. “Although the authors have not been able to prove that sleeping pills cause premature death, their analyses have ruled out a wide range of other possible causative factors,” wrote Dr Trish Groves, editor in chief of BMJ Open. “So these findings raise important concerns and questions about the safety of sedatives and sleeping pills.” National Health Service (NHS guidelines recommend zolpidem should only be used at the lowest possible dose and for a maximum of up to four weeks. Zaleplon should only be used at the lowest possible dose and for a maximum of up to two weeks, while temazepam should be taken for a maximum of four weeks. Most of those in Kripke’s study were taking Ambien or Restoril. Sanofi-Aventis, the maker of Ambien, noted that Kripke’s study had a number of faults. “Ambien has more than 17 years of real-world experience and is safe and effective when prescribed and taken according to its labeling,” Sanofi told WebMD in a statement. “Ambien should be prescribed in strict adherence to its labeling and patients should take their medication as prescribed. The Ambien labeling carries specific warnings against driving and against intake of alcohol together with Ambien.” And although experts note the Kripke study certainly raises concerns, they said it does not prove that sleeping pills kill. This “very provocative and interesting study raises a lot of questions,” Nancy Collop, MD, president of the American Academy of Sleep Medicine and director of the Sleep Center at Emory University School of Medicine, told WebMD. “You cannot assume, just because you find this kind of association, that hypnotics are killing people,” she said. “People who go on sleeping pills are a sicker population. I know they tried to control for that, but these people simply are not as healthy.” Michael Yurcheshen, MD, head of the sleep fellowship program and assistant professor of neurology at the University of Rochester, NY, noted that much can be missed in a study that looks back at medical records rather than at the patients themselves. “It is implausible to think that so many of these medications, spread across several different drug classes, could have the same biological effects,” Yurcheshen told WebMD. Yet, both Collop and Yurcheshen praise Kripke for raising the issue of sleeping pill dangers. “One part of the Kripke study I really did like is when they point out that part of the problem with hypnotics is they are really best for people with acute, short episodes of insomnia,” Yurcheshen said. “Very few insomnia drugs are approved for long-term daily use. And so it is fair to say that the long-term safety of these drugs has never been explored for use in that way.” Collop said she is torn on the issue of whether hypnotics are “good or bad.” She noted that it can be harmful to be dependent on hypnotic sleeping pills for a long period of time. But they can be very helpful to those who are having great difficulty in falling asleep for some specific reason. She noted that sleeping pills are mainly short-term use aids. “So the ideal patient would be someone with a very high stress level for some reason, such as the recent loss of loved one or a divorce, or for a traveler adjusting to a new time zone. This should be for a limited time period and only as needed, not on a nightly basis. In such situations these drugs are appropriate and effective,” she told WebMD. Kripke, colleagues and the experts all agree that a form of short-term psychotherapy -- cognitive behavioral therapy -- is surprisingly effective for people with chronic insomnia. Collop says it’s time to see a sleep specialist if you have tried sleeping pills and they don’t work anymore. Looking for another brand of sleeping pill will not work. Nina Barnett, spokesperson for the Royal Pharmaceutical Society told The Telegraph: “This is an important study and although it is unlikely to radically change prescribing in the immediate term, it should raise awareness and remind both patients and prescribers to the potential risks of sedative use for insomnia.” “The association between mortality and sedation is not new and this research tells us is that people who took these medicines were more likely to die than people who didn’t take them. However it does not mean that the deaths were caused by the medicine,” she added. “Patients should not stop taking any prescribed medicines straight away. If you are concerned about your medicines discuss this with your pharmacist or Doctor about other ways of getting help with sleep problems so you don’t have to use medicines.” --- 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-




01.03.2012 4:20:24
Christopher Scanlon

How would you feel if your local GP or specialist was pocketing money from a drug company to promote its products?

If your gut says tells you that this falls into the category of Very Bad Ideas then it turns out that you're out of step with most Australians - at least if you believe the PR efforts of drug companies.

A
recent press release trumpeted 'Majority support sponsorship between pharmaceutical companies and healthcare professionals if publicly declared'.

The press release was issued by GlaxoSmithKline, which manufactures everything from Panadol to the asthma medication Ventolin to the antidepressant Aropax.

This surprising claim was based on a questionnaire of over 1,000 Australians which asked how they felt about pharmaceutical companies paying fees to doctors. When asked, 90 per cent viewed it in a negative light. But opposition melted away when people were given - in the words of the press release - 'further information about the purpose of the funding'.

But what was this 'further information'?

Here's the text from the questionnaire:

The fees may be paid to help fund medical research, clinical education programs and provide payments for those that devote time to develop new medicines and advise how best to use them.

Seventy-nine per cent approved of pharmaceutical companies helping to fund medical research programs and 71 per cent agreed with money being used to fund clinical education programs.

On the face of it, that all sounds uncontroversial. After all, who could be opposed to research and education?

The devil though, as always, is in the details. For example, what exactly constitutes an education program? To most people, that sounds like a pharmaceutical company paying a doctor to undertake further training in new treatments or procedures.

Reality, however, can be a little different. In the world of the pharmaceutical industry, education can mean flying a medical 'opinion leader' business class to a company-sponsored symposium held at an attractive overseas venue to 'educate' GPs about a company's drugs. The purpose of these educational sessions is, of course, to influence doctors to prescribe the company's drugs over its competitors.

To be clear, it's not being suggested that GlaxoSmithKline engages in such activities. But such practices are common within the pharmaceuticals industry. They are also lucrative for the individual doctor's involved. As the ABC Radio National's Background Briefing program
reported in October last year, former pharmaceutical company representative Petra Helesic told of doctors - mainly specialists - being paid between $750 to $1,500 per presentation to deliver promotional presentations. The drug companies even dictated the topics and provided the PowerPoint slides to ensure the doctor stayed on message.

These 'education' sessions weren't always held in clinics, lecture halls or conference rooms. In some cases, they were held at Sydney's top restaurant where the assembled doctors were plied with free food and wine.

In Australia at least, pharmaceutical companies aren't obligated to report the amount spent on such activities. The Federal Government's most recent review of therapeutic goods regulations in 2011, which included promotional practices, concluded that pharmaceutical companies can regulate themselves when it comes to paying money to doctors.

This is despite a range of criticisms directed at self-regulation that have been presented to the Federal Government. In his submission to the Federal Government's review of the therapeutic goods regulatory framework, for example, Dr Ken Harvey, senior lecturer in the School of Public Health at La Trobe University and an expert on health promotion, criticised
self-regulation as 'self-serving'. (Full disclosure: I also work for La Trobe University.

Dr Harvey noted that the existing rules on public disclosure have gaps - targeting doctors, but not pharmacists, for example - and the penalties imposed are a fraction of their equivalents in the United States.

Drug companies in the United States have far stricter disclosure requirements than in Australia. Since 2010, US drug companies are compelled to report payments and in-kind support they give to individual doctors over a cumulative amount of $100.

GlaxoSmithKline, to its credit, has led the way in reporting the overall amount it spends on healthcare professional sponsorships. Since 2011, it has disclosed the total amount spent on sponsorship of health care professionals.

However, GlaxoSmithKline's own research indicates that an overwhelming majority of Australians want the pharmaceuticals industry to take the next step and disclose their relationship with each and every sponsored doctor.

The same questionnaire which asked how people felt about pharmaceutical company payments to doctors found that 65 per cent of respondents prefer drug companies to 'disclose each and every individual sponsorship of specific doctors and specialists'.

Perhaps unsurprisingly, this finding didn't make it into GlaxoSmithKline's press release.

There may be legitimate reasons for drug companies to pay doctors. But if that's the case, then it should be above board. Patients should be able to find out who's paying their GP or specialist - and possibly influencing their prescribing practices.

Christopher Scanlon teaches Journalism at La Trobe University and is co-founder of
www.upstart.net.au. View his full profile
here.




29.02.2012 22:34:00


Photo courtesy of Flickr user
Mr. T in DC.

Grab some chocolate, pop an aspirin and wash it all down with red wine. You're on your way to a heart-healthy life, right? Not so fast.

According to Dr. Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, much of the information Americans use as a guide for heart health is little more than folklore.

"It's appalling," he said. "And it's getting worse. These days, you can conduct an Internet search for any heart condition and get a lot of information. The problem is most of it is wrong. And a lot of the common mythology is wrong, too."

In a new book, "
Heart 411," Nissen and his colleague, cardiac surgeon Dr. Marc Gillinov, approach some of the more popular rumors "the way a jury would approach a trial": Is there evidence beyond a reasonable doubt that red wine is good for your heart or that red meat is bad?

On this final day of American Heart Month, Nissen shared some of their verdicts.

Myth 1: Red Wine

"It turns out that there's no information to suggest that red wine is better than any other form of alcohol for your heart," Nissen said. "But there is information to show that moderate alcohol intake of any kind -- red wine, white wine, beer or hard spirits -- benefits patients in preventing heart disease. It does so by raising the good cholesterol, or HDL.

"The myth about red wine came from the so-called French paradox -- that the French drink a lot of red wine and they have a relatively low instance of heart disease, despite the fact that they eat a lot of fat. People began to think maybe red wine was protecting them. And there was a little bit of research in animals showing that an element of red wine known as resveratrol seemed to be protective in mice. But what the public didn't get was that they gave thousands of times more resveratrol to the mice than humans would ever get from drinking red wine, and the research just didn't hold up in additional studies.

"At the end of the day, we don't recommend taking up drinking to benefit your heart. But if you do drink a glass or two of alcohol per day, depending on your body mass, it can be a heart-healthy activity."

Myth 2: Red Meat

"Red meat is a source of saturated fat, and all other things being equal, saturated fat does tend to raise the bad cholesterol, LDL. And so it's not a good thing," Nissen said.

"However, we stress the importance of a diet we call, 'no-fad.' One of the most disturbing current trends promises that if you eat no meat and virtually no fat, you'll become 'heart attack proof.' Our conclusions from the research out there is that this is just utter nonsense -- that there are no 'heart-attack-proof' diets, that completely eliminating fat, including meat, does not have a convincing health benefit, and that in fact a balanced diet is best.

"We advocate what is called the Mediterranean diet -- one that actually has quite a bit of fat -- good fat like olive oil and canola oil, fats that contain polyunsaturated fatty acids and not a lot of trans fats. If someone promises you that a diet will melt away the plaque in your coronary, run as fast away from those diets as you can.

"Eating red meat in moderation is not a problem. It's not good for your heart, but if you don't exceed reasonable quantities -- small amounts of red meat as part of a balanced diet -- it is not something people need to avoid."

Myth 3: Chocolate

"There is a little bit of evidence -- and it's not very strong -- that dark chocolate is probably an OK food for the heart," Nissen said. "There's even a small study that seems to indicate that dark chocolate might lower blood pressure a little bit. But the effects are very small, and all chocolate tends to have a fair amount of calories and a lot of sugar.

"And so to call any chocolate a heart-healthy food is a mistake. This is another example, because it's cutesy, because it's newsy: Whenever one of these poor-quality studies comes out, they get latched upon by the media. But the truth is there are no randomized control trials of any quality on this subject.

"In our book, we talk about the difference between an observational study and a randomized control trial. Most of the alcohol and chocolate studies do not come from randomized control trials, where you would give half the people these substances for five years and half of them would avoid it altogether and you find out who does better. In fact, they come from observational studies, which are inherently flawed. And so the solidity of the evidence is much more limited when you have only observational data."

Myth 4: Work-Related Stress

"It's not a huge factor, but it does appear to play some role in a minority of heart attacks," Nissen said. "We actually have some pretty good scientific data that extreme levels of stress can cause something called
Broken Heart Syndrome, which is caused by a sudden rush of stress.

"The best data comes from some interesting observations that during the Super Bowl, when a person is rooting for his or her team and their stress and anxiety goes up, there appears to be more heart attacks. But even better data comes from places like Israel, during the first Gulf War (and the Scud missile attacks. When people were under tremendous stress, there was a big bump in the rate of heart attacks.

"All of this shows that stress under some circumstances, particularly when it's extreme, can trigger a heart attack. But it is also important to note that we are pretty well-adapted as a species to handle stress. Our ancestors had lots of it. When we were swinging from the trees in the jungle, there were predators chasing after us. And so stress is not just a function of modern life. We don't think chronic stress is good for people. It does seem to raise levels of inflammation in the body. But people should not believe that if they've got some stress in their lives, it's going to make them have a heart attack. Stress is a factor, but it's certainly not the most important factor in heart disease."

Myth 5: Sex

"It's extremely rare, but you can have a heart attack from sex," Nissen said. "There is some data -- and this is perhaps comforting to some spouses in the country -- that sex with your regular partner does not raise the heart rate and blood pressure to levels that are strongly associated with having a heart attack.

"However, sex with a non-regular partner, particularly if you're in an extramarital relationship, does seem to have an association with an increased risk of a heart attack. And I think the reasons that most people have surmised is that there is more excitement involved. There may be a fear of being caught and there's maybe some guilt. For all of those reasons, heart rate and blood pressure go up and may act as a trigger for a heart attack.

"So it's one more reason to stay faithful to your spouse. On the opposite end of the spectrum, don't count on sex as your form of exercise for the day. For most of us, the duration of activity is insufficient to meet the aerobic needs of an exercise program."

Updated March 1: Here is the second set of myths as explained by Nissen:

Myth 6: Dietary Supplements

"Almost all of our patients come in taking dietary supplements, and they believe that it will help their heart health because it says right on the bottle, 'Promotes heart health.' These are products like fish oil, coenzyme Q, and the big rage now, Vitamin D. You know, if you go into the local pharmacy, you can find row after row after row of dietary supplements -- many I haven't even heard of. And none of these claims have been evaluated by the Food and Drug Administration.

"In fact, in a great national tragedy in 1993, Congress passed a law that barred the FDA from regulating dietary supplements. And so we don't even know whether most of the dietary supplements actually contain the ingredients they claim to contain. At the moment, everybody is taking Vitamin D, and there just isn't evidence that it protects the heart. More importantly, it diverts patients away from the real therapies that they need.

"Often when we go on a book signing, we will ask the audience how many people take fish oil. And lots of hands go up. And then we ask them, 'Do you think the fish oil lowers your cholesterol?' and most of the hands go up. Fish oil actually raises levels of LDL cholesterol -- it doesn't lower it, it raises it. But the problem is those claims cannot be regulated because the FDA is virtually powerless. Sooner or later there will be a major national catastrophe.

"We also warn people that these dietary supplements can even interact with their prescription medications, causing them to become toxic or ineffective. And so there are no dietary supplements that we recommend for patients."

Myth 7: An Aspirin a Day

"Another long-standing myth is that it's a good idea to take an aspirin a day for people who are at risk for heart disease. In fact, if you're at low enough risk -- if you're an otherwise healthy 40- or 50-year-old man or woman -- it actually increases your risk of adverse consequences, including bleeding into your brain and into your stomach. That's because aspirin is an anticoagulant, it prevents clotting of the blood. And that is, of course, a benefit but it's also a risk.

"In the stomach, it has been found to irritate the lining by affecting something known as the prostaglandins, which are protective in the stomach. When those prostaglandins are altered, the stomach is more vulnerable to the effects of acid, leading to erosion of the stomach and bleeding. And the second mechanism is that because aspirin is an anti-platelet agent, it actually prevents blood clotting. And so the combination of irritation to the gastro-intestinal tract plus the anti-coagulant effect is what leads to an increased risk of gastrointestinal bleeding, which is quite significant.

"As for the brain, people of certain ages have areas of weakness in the blood vessels of the brain, and if you get a little bit of a break in those blood vessels and your blood clots normally, nothing bad may happen. But if you have an anticoagulant on board, you may have a serious cranial bleed. When you add it all up, for people who are otherwise healthy, the risks exceed the benefits of taking an aspirin a day."

Myth 8: Stress Testing

"This is an often-unnecessary test in which a patient walks on a treadmill and has their electrocardiogram monitored so that the physician can look for changes that may be a consequence of not getting enough blood flow to the heart muscle. It's a test that's very commonly done in America millions of times each year, and many people are having them done who shouldn't. In fact, we strongly discourage it in most cases unless the patient is having chest pain symptoms.

"The problem with it is that there are too many false positives and no evidence that screening people with stress testing actually improves their health. These tests often lead to an angiogram and ultimately, to unnecessary coronary interventions, like a stent. Why is this being done so much? Well I hate to be so cynical, but one of the reasons is that are certainly economic incentives for doctors to over-test. Some people have the test done simply because they tell their doctor they want to start an exercise program and their doctor will say, 'OK, well let's do a stress test on you.' People should push back against those kinds of recommendations if they don't have any of the symptoms of heart disease."

Myth 9: Calcium Testing

"This is another test commonly performed and widely advocated that we don't recommend. People are put in a special kind of CT scan and their doctor looks for calcium in the coronaries of the heart. When you see calcium, it usually means there's plaque in the coronaries, and physicians can then try to prevent heart disease. The problem is that we should be preventing people with risk factors whether or not they have calcium in their coronaries. And so essentially it doesn't give us information that we can use productively to prevent people from dying or having a heart attack.

"Even though it may have some predictive value, it also can lead to more testing and some pretty significantly bad consequences. If a minor blockage is found, the temptation is often very high to do an angiography, to do a catheterization, and sometimes, even to put in a stent. There's no evidence that if you take somebody who doesn't have symptoms and do a heart catheterization, that anything you find will actually benefit the patient. And so it's driving up health care costs. America spends more on health care than any other country by a factor of about two, and this is one of the reasons why."

Myth 10: Women Don't Feel Chest Pain During Heart Attacks

"This one is just pervasive. After a recent article in JAMA (the Journal of the American Medical Association , this has been covered by the media a lot -- that many women who have heart attacks don't have chest pain. While that may be true for some women, it's important to understand that the principal symptom of a heart attack in both men and women is chest pain. About 12 percent of women are more likely not to have chest pain during a heart attack, but that's not a huge difference.

"Women may just have a shortness of breath or dizziness or pass out, but the same is true for a small percentage of men. Men and women are more alike than dissimilar. There are some differences, but they're not as big as people may think. For heart attacks, the same advices should be given to both genders: If you have chest pain, if you have a sudden onset of severe shortness of breath, if you get dizzy, light-headed and sweaty all of a sudden, take it seriously, call 911 and get to the hospital -- whether you're a man or a woman."






Pharma International's US Correspondent
01.03.2012 8:16:50

Certain leukaemia drug treatments might stop the Ebola virus developing in the body, according to new US research unveiled on 29 February 2012.

Fatal in all but 10 per cent of cases, Ebola was first identified in Africa around four decades ago. It's comparatively rare but, even so, has come to be regarded as a highly dangerous condition.

However, two leukaemia treatments drugs - imatinib and nilotinib - seem to be able to prevent reproduction of the Ebola virus, according to data released by the US National Institute of Allergy and Infectious Diseases and subsequently published by Science Translational Medicine.

Leukaemia Drug Ebola Treatment

The leukaemia drug Ebola treatment findings followed lab-based trials involving embryonic kidney cells, which revealed that the c-Abl1 tyrosine kinase protein was instrumental in the virus replication process. By putting the brakes on this protein's activity, the researchers were able to stop the Ebola from spreading.

Alongside this, the leukaemia drugs also prevented the Ebola-infected cells from releasing viral particles - a mechanism called ‘filovirus budding'.

‘Drugs that target filovirus budding would be expected to reduce the spread of infection, giving the immune system time to control the infection', the US National Institute of Allergy and Infectious Disease representatives explained in their report, adding: ‘Our results suggest that short-term administration of nilotinib or imatinib may be useful in treating Ebola virus infections.'

Ebola Virus Treatment Study

Imatinib has several trade names including Glivec and Gleevec and it's prescribed to chronic myelogenous leukaemia patients, while nilotinib, which is marketed as Tasigna, treats the same condition but in cases where imatinib hasn't helped.

Referring to both drugs, the Ebola virus treatment study's authors described their ‘safety profiles' as ‘reasonable' but added: ‘some cardiac toxicity has been reported with long-term administration in a small number of patients.'

Data release by WHO (the World Health Organization reveals that, over the past 36 years, there's been 1,200 fatal cases of Ebola recorded around the world.

At the very end of 2011, Pharma International reported on the development of a
long-lasting effective Ebola vaccine. Prior to that, we covered
MIT's DRACO drug - a product with the potential to kill almost every virus known to man, Ebola included.

Image copyright Public Library of Science - Courtesy Wikimedia Commons




29.02.2012 23:39:00

Education vital to curbing Saskatchewan’s rise in infections: doctor

News

Tannara Yelland — CUP Prairies & Northern Bureau Chief

SASKATOON (CUP — While the recent HIV epidemic in Saskatchewan has made headlines — the rate of annual new infections is at least twice that of anywhere else in Canada on a per capita basis — people on the front lines attribute the startling rate of infections to larger and more systemic problems such as poverty.

When Ken Ward was diagnosed with HIV in 1989, he initially told everyone that he had cancer because “it seemed a lot more acceptable.”

“Being an addict, we deal with loneliness no matter what,” said Ward, who is from the Enoch Cree Nation west of Edmonton, Alta. “But also being double-impacted with the diagnosis, I knew that I had to keep this secret quiet because of fear. Fear of not being accepted, or [of being] targeted... Trusting has always been a big issue with me, ever since I was molested in a residential school and raped at 13.”

However, after his mother accidentally leaked his HIV-positive status to organizers of a rally in 1990, Ward went public with his diagnosis. He has spent the last 20 years doing advocacy work for HIV and AIDS patients in Canada, and was one of the first aboriginal men in Canada to go public about his diagnosis.

Struggling with addiction for almost 20 years, as well as being molested and bouncing through various foster homes, Ward has lived through many of the experiences that are disturbingly common among Canada’s First Nations population.

“I think three quarters of my family were dysfunctional, mostly alcoholics,” Ward said.

As with so many others in Canada and especially in Saskatchewan, drug use led directly to Ward’s HIV diagnosis: he was infected by a shared needle. This is fairly typical of Saskatchewan’s infection trends, says Dr. Stephen Helliar, who has worked at the Westside Community Clinic in Saskatoon for 31 years.

“There is some sexual transmission,” he said, “but by far the largest number [of those infected] are injection drug users.”

Working among Saskatoon’s poor and homeless communities for three decades, Helliar has seen the current epidemic develop firsthand. And while he confirmed that the vast majority of new cases are among drug users, he says the larger community should be aware of the high infection rates around them.

“In 2007, we had roughly maybe 30 people who were HIV positive at the Westside [Clinic]; we now have somewhere around about 340 to 350,” he said. Helliar personally sees about 100 of those patients.

When asked about what he sees as the causes of Saskatchewan’s HIV problem, Helliar stressed the fact that HIV “has become a disease of poverty” and other similar social determinants of health, such as housing and addiction. Thus while it is true that there are a disproportionately high number of aboriginal people in Saskatchewan being infected, this is due to the fact that aboriginal people are disproportionately affected by poverty.

“I think the first thing [the government] needs to do is work on the whole issue of poverty and try to relieve that,” said Helliar, “and the housing situation and relieve that, as well as putting in more human resources to deal with HIV.”

The provincial government is in the process of implementing a four-year strategy to deal with HIV; its four focal points are education, prevention and harm reduction, research, and clinical management. The main goals of the strategy include improving life and housing for current HIV-positive people; working to prevent both addictions and new HIV cases; and to reduce the stigma and isolation HIV-positive people experience, both in life and, most importantly, in the medical community.

“They’ve certainly increased the number of health workers that are working with this issue,” Helliar said. “And so in that way it’s helped, but we are still being overwhelmed by this problem. Yes, there has been an improvement, but it’s certainly not enough.”

Both Ward and Helliar acknowledged the prejudice that many members of the medical community still hold toward HIV patients. Ward says loneliness and isolation are among the most difficult things for people to deal with when they are diagnosed.

“I’m really pleased that the nurses are now coming to the forefront and wanting to understand, because they’re usually the welcome mats [for] anybody who’s diagnosed,” said Ward.

Still, he says, more needs to be done. Child and family services, correctional workers and more medical professionals all need to receive thorough education to combat prejudice.

Helliar echoed Ward’s concerns. Many health care workers, he says, either don’t want to treat HIV-positive patients who are addicted to drugs or don’t put forth the effort to make the patients feel welcome.

“They’re certainly made to feel that they’re not wanted there.”

The key to changing this, Helliar says, is education.

“Try and get people [in the medical profession] to understand why people become addicted, and that people, even if they have an addiction problem, are human beings and need to be treated with the same respect that you would treat any person.”

Another key problem that goes hand in hand with both injection drug use and the over-arching problem of poverty is homelessness. Ward hinted at having led a very transient lifestyle earlier in his life, saying he had been “what you might call a ‘gypsy.’” From residential schools and foster homes to his younger adulthood, Ward “just migrated from city to city most of my life.”

Helliar says this is also typical of many patients he sees, and is a huge impediment to treating patients properly. Whether it be diabetes or HIV, chronic illnesses are significantly harder to treat when the patient does not have a stable, consistent home to return to.

“HIV in general has become a disease of poverty,” Helliar said, “and the vast majority of the people that live in poverty are more likely to get HIV. Our aboriginal community lives in poverty, and therefore First Nations people are certainly a large percentage of the people that we see that are HIV positive.”

-30-




29.02.2012 2:03:21




Screen_shot_2012-02-28_at_4.03.09_PM.png



Nassau, Bahamas - It has come to the attention of the Ministry of Health that some counterfeit drugs are being sold in The Bahamas.

As a result, the Ministry together with The Bahamas Pharmacy Council has appointed a Committee chaired by the Chief Medical Officer, Dr. Merceline Dahl-Regis, to investigate allegations of the importation and distribution of counterfeit drugs by at least one pharmacy in The Bahamas. 

The Committee will be assisted in its investigation by the Pan American Health Organisation (PAHO ...





01.03.2012 7:21:00

 

Lectures and promotion for  Pharmaggedon  and  RxISK.org.

Have updated my speaking calendar with some more details:

Date Time City   Location   Details
5 March 12-1pm Boston   Tufts University (Farnsworth 250 Conference Room   The Changing Face of Psychosis
8 March 9:30-10:30am

 

12-1pm

New Jersey   Rutgers (First Floor Conference Room, Institute for Health, Health Care Policy, and Aging Research Building, 112 Paterson St., New Brunswick   The Changing Face of Psychosis: Implications for Treatment

The Eclipse of Medical Care

9 March 6-9pm New York   City University of New York (365 Fifth Ave, The Graduate Center, Room 6304.01   The Psychology of Drugs and Risk
12 March 4-6pm Toronto   University of Toronto

Leslie Dan Faculty of Pharmacy (144 College St., Room B150
  The Eclipse of Medical Care
14 March 3:45-5pm Hamilton   University of McMaster  (Room HSC-4E20   The Eclipse of Medical Care
19 March 12-1pm San Francisco   Commonwealth Club   The Eclipse of Medical Care
20 March 2-4pm Los Angeles   Harbor UCLA   Hearts & Minds – Pregnancy and Antidepressants
20 March 8pm and 11pm (ET TV appearance   TV Ontario   The Agenda with Steve Paiken
22 March 12-1pm Los Angeles   VA Hospital   The Changing Face of Psychosis
23 March 12-2pm Los Angeles   Providence Tarzana Medical Center (LA   The Psychology of Drugs and Risk

     

-->

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2012-02-29 06:16:38
The U.S. Food and Drug Administration (FDA announced on Tuesday that they would be adding memory loss and diabetes warnings to the labels of cholesterol-lowering drugs known as statins. According to Reuters reporters Bill Berkrot and Ransdell Pierson, the label changes come after the agency learned of studies in which taking statins could lead to a small increased risk of cognitive issues such as memory loss or confusion, as well as a slight spike in blood sugar levels and the risk of developing type 2 diabetes. FDA spokesperson Erica Jefferson told Reuters that the changes were "part of our ongoing surveillance." The affected products include Lipitor (atorvastatin , Lescol (fluvastatin , Mevacor (lovastatin , Altoprev (lovastatin extended-release , Livalo (pitavastatin , Pravachol (pravastatin , Crestor (rosuvastatin , and Zocor (simvastatin . Combination products include: Advicor (lovastatin/niacin extended-release , Simcor (simvastatin/niacin extended-release , and Vytorin (simvastatin/ezetimibe , the FDA said in a statement reprinted by Tuesday. When asked about the changes, Cleveland Clinic Cardiology Chairman Steven Nissen told Forbes reporter Matthew Herper that the blood sugar warning is the result of "a very small uptick in blood sugar that makes a few more people cross the threshold we call diabetes." “This small increased risk of higher blood-sugar levels needs to be taken in the context of the very strong evidence of beneficial things that are provided by statins,” added Matthew Price, director of the cardiac catheterization laboratory at Scripps Clinic in La Jolla, California, in a telephone interview with Bloomberg's Anna Edney and Michelle Fay Cortez. “This doesn’t affect my prescribing of statins where it’s clinically indicated, though I will make sure I closely follow patients at risk for diabetes.” In terms of the cognitive issues, the FDA said that reports of memory loss and/or confusion were not series, and in most cases the symptoms were reversed after the patient stopped using the statin. The agency also noted that they would be removing a requirement for regular monitoring of liver enzymes for those using the cholesterol medication, after concluding that serious liver injury was "rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect." They did, however, warn patients to contact their doctors if they experienced any symptoms of liver-related ailments, including weakness or fatigue, loss of appetite, dark-hued urine, yellowing of the skin or the whites of the eyes, or upper abdominal pain. “We want health-care professionals and patients to have the most-current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol,” Mary Parks, director of FDA’s division of metabolism and endocrinology products, told Edney and Cortez. --- On the Net:



29.02.2012 11:00:00
WEDNESDAY, Feb. 29 (HealthDay News -- Federal laws requiring medical companies to conduct pediatric drug studies have helped provide guidance on whether it's safe or effective for children to use certain medications, a new U.S. report finds. The ...



01.03.2012 18:16:43
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: FDA Approves Four-Strain Flu Vaccine A new nasal-spray flu vaccine approved by the U.S. Food and Drug Administration protects against four...



28.02.2012 21:33:40

pig

The rise of antibiotic-resistant bacteria has got
many experts predicting a future in which currently tractable diseases, like tuberculosis, became untreatable again. The popularity of modern antibiotics, ironically, is what is leading to their downfall: antibiotics in consumer products, like soaps, as well as the excessive use of antibiotics by people who have no bacterial infections, help select for strains of bacteria that don’t respond to drugs. Factory-farmed livestock, which receive tremendous doses of antibiotics in their feed, are also a likely breeding ground for resistant bacteria that could potentially infect humans.

Proponents of factory farming have
scoffed at such claims [pdf], but now, scientists have
provided definitive evidence that this happens: through genetic analysis, they found that a strain of
MRSA, already resistant to one family of drugs, had hopped from people to farmed pigs, acquired resistance to another antibiotic being fed to the pigs, and then leapt back into humans, taking its new resistance with it. That strain, called MRSA ST398 or CC398, is now causing
1 out of 4 cases of MRSA in some regions of the Netherlands [pdf], where it arose, and it has also been found across ...




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01.03.2012 14:45:00

BRUSSELS (Dow Jones --The European Commission said Thursday it has closed an antitrust investigation into possible deals between pharmaceutical companies AstraZeneca PLC (AZN and Nycomed SCA after finding no wrongdoing.

"The investigation focused on suspected individual or joint action to delay the market entry of generic medicines," the commission, which has antitrust powers in the European Union, said in a statement. "Such behavior if established would have been contrary to EU antitrust rules that prohibit restrictive business practices and the abuse of a dominant market position," it said.

The commission's antitrust authorities have in recent years specifically targeted the pharmaceutical sector to ensure companies don't restrict competition from generic drugs to the detriment of patients. The efforts are part of governmental efforts in Europe and elsewhere to cut drug prices across the board to limit spiraling health-care costs.

Ensuring the free flow of generics is considered necessary to help bring down medication costs by as much as 80%, allowing governments and state health insurers to save billions of euros.

-By Alessandro Torello, Dow Jones Newswires; +32 2 741 14 88;
alessandro.torello@dowjones.com

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29.02.2012 1:20:07
AP - Federal health officials are adding new safety warnings about risks of memory loss and elevated blood sugar to statins, the most widely prescribed group of cholesterol-lowering medications.



29.02.2012 10:00:00
Title: Autoinjector Version of MS Drug Approved


Category: Health News


Created: 2/28/2012 6:06:00 PM


Last Editorial Review: 2/29/2012



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29.02.2012 9:00:00

With addictive painkiller OxyContin being phased out in Canada, health experts are calling for a national strategy to confront prescription painkiller abuse. OxyContin is the most well known form of the narcotic painkiller oxycodone (technically, oxycodone hydrochloride...

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