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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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."






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:



02.03.2011 19:31:34


PATIENTS THINK THAT DOCTORS STAND IN THE WAY OF THEIR RECEIVING THE BEST TREATMENT AND CARE





A 400-page report, What do patients think of doctors?, published in early-March 2011 by UK research organisation PatientView, finds that over half (53% of the 2,500 respondent patient groups think patients believe doctors are standing in the way of their receipt of the correct diagnosis, treatment and and/or support—and are making patients ‘fight the system’ to obtain the care they need.

The situation is at its worst in five countries—Canada, Germany, Italy, New Zealand and the UK—where 60% or more of patient groups say that health professionals need to improve their relationships with patients by not making patients fight the system for their medical needs. 70% of patient groups representing the interests of patients with gastrointestinal problems, 60% representing the interests of patients with multiple sclerosis, and 60% rare diseases, feel that health professionals need to stop forcing patients to ‘fight the system’ to get the care they need.




Poor doctor-patient relationships have a negative effect on patient health


What do patients think of doctors?

focuses on the current state of doctor-patient relationships, and offers numerous insights into how they can be improved. The report finds that less than a third of groups representing patients believe GPs and consultants remain traditional and patriarchal in their attitudes to patients. On the other hand, only 15% believe that doctors treat patients as equals (and act on that belief —the rest believe that the situation varies from doctor to doctor, or that doctors may intend to take a partnering role, but fail to live up to it. Relationships between doctors and patients are undoubtedly in need of considerable improvement, especially in some of the less well-performing countries. The state of doctor-patient relations has an important bearing on how well patients respond to treatment. In the report, patient groups are quoted as saying that poor doctor-patient relationships prevent patients from coming forward for medical treatment and care—even when treatment and care is needed.


Doctors need to listen more to the patient

When asked what single intervention would most improve doctor-patient relationships, the groups cite “enhancing the communication-and-understanding skills of the healthcare professional” as their main choice, second only to “the provision of treatment and care that improves quality of life”. In Australia, Italy, New Zealand and the UK, improving doctors’ communication-and-understanding skills is ranked first, as the most important way of improving doctor-patient relations. Groups representing the interests of patients with cancer and HIV/AIDS also see such a development as the favoured way of improving doctor-patient relations among the patients in their disease specialties.


About the survey




What do patients think of doctors?

is based on the results of a November 2010 PatientView survey of 2,500 patient groups from around the world. The survey asked the respondent groups what they think of current doctor-patient relationships, and how they believe those relationships might be improved.

The report covers most subject areas in which patients would like doctor-patient relations to be improved, including:

l

Access to health professionals



l

Access and choice during diagnosis and treatment

l

Patient information provided by health professionals

l

Doctor-patient communication

l

Gaining patient trust

l

Respecting patients’ valuable time

l

Accountability of health professionals

l

Improving prevention practices

l

Which single action do patients want from government and payers to improve doctor-patient relationships?

l

Which pharmaceutical companies are having a positive effect on doctor-patient relationships?

l

Why pharma can have a negative impact on doctor-patient relationships.

The report analyses doctor-patient relations in 11 countries and one region of the world: Australia [
number of completed responses = 60
]; Canada [
138

]; Eastern Europe [
105

]; France [
80

]; Germany [
100

]; Italy [
110

]; the Netherlands [
30

]; New Zealand [
55

]; Spain [
80

]; Sweden [
56

]; the UK [
566

]; and the USA [
292

]. Doctor-patient relations are also analysed for the following 12 specialties: cancer
[160
]; diabetes [
55

]; gastro-intestinal [
40

]; heart and circulatory conditions [
70

]; HIV/AIDS [
72

]; mental health [
170

]; multiple sclerosis [
35

]; neurological [
195

]; Parkinson’s disease [
30

]; rare diseases [
70

]; respiratory [
35

]; and rheumatological conditions [
55

]
.

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29.02.2012 5:48:21

North Eastern Region

Biotechnology
Progeamme Management Cell (NER-BPMC

NER-BPMC has been set up by the Department of

Biotechnology
, Ministry of Science & Technology, Government of India through Biotech Consortium India Limited (BCIL for development, coordination and monitoring of

Biotechnology
programmes in the North Eastern States of India. Applications under NER-BPMC are invited for the posts of four Senior consultants one each in the area of Healthcare / Medical

Biotechnology
,

Agriculture
, Animal Sciences / Livestocks, HRD.

Post : Senior Consultant

  • No of Posts : Four
  • Stream : Healthcare / Medical

    Biotechnology
    ,

    Agriculture
    , Animal Sciences / Livestocks
  • Essential Qualification : Candidates having master's degree in the respective areas ie

    Life Sciences
    ,

    Biotechnology
    , Pharma,

    Agriculture
    , Animal Sciences, Livestocks from a recognized Unversity with a minimum of 10 years of relevant experience in the respective areas preferably in implementing major research programmes.
  • Desirable : Candidates having

    PhD
    in respective areas with experience in handling projects in North Eastern Region of India and recently superannuated would be preferred.
  • Emoluments : Rs 60000/- pm with conveyance allowance of Rs 30000/- pm


The above full time consultancy assignments are contractual for a period of aone year with a scope of further extension. Please apply latest by 12th March 2012 with detailed resume (Soft copy only strictly in the format given at
www.bcil.nic.in by email to :
The Managing Director
Biotech Consortium India Limited (BCIL
Anuvrat Bhawan, 5th Floor, 210
Deen Dayal Upadhyaya Marg
New

Delhi
- 110002
Tel : 011-23219064; Fax : 011-23219063
Email :
career@biotech.co.in

Deadline : 12.03.12

View Original Notification



http://www.biotecnika.org/content/february-2012/north-eastern-region-biotechnology-progeamme-management-cell-ner-bpmc-bcil#comments

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