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
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^>
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
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.
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
The DEA says the Lakeland distribution center posed a danger to public health. A DEA investigation found Cardinal shipped 50 times as much oxycodone to its four top pharmacies in Florida as to its other retail customers. In 2011, a CVS pharmacy in Sanford, Fla., purchased 1.8 million pills from Cardinal, DEA records show.
An average U.S. pharmacy dispenses 69,000 a year, the DEA said.
The amounts "were astounding — far above what I would expect from pharmacies of similar size in a city such as Sanford, Florida," DEA Administrator Michele Leonhart said in a sworn statement.
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."
Vincent Moellering heard a rumor in April 2009 that a local pharmacy was selling the powerful and addictive painkiller oxycodone by the pill for cash. So Moellering, an investigator for Cardinal Health, one of the nation’s largest distributors of pharmaceuticals, visited Gulf Coast Medical Pharmacy in Fort Myers, Fla.
Over the next two years, Moellering and other Cardinal employees visited that pharmacy at least four more times. Each time, they noted disturbing signs: Customers paid cash, oxycodone was the No. 1 seller, and young people came in groups to have their prescriptions filled.
On Oct. 5, 2010, Moellering’s fourth visit, pharmacy owner Jeffrey Green told him he wanted more oxycodone. The store had dispensed 462,776 pills over two months — nearly seven times what the average pharmacy dispenses in a year. Convinced something was off, Moellering asked Cardinal’s permission to contact the Drug Enforcement Administration, according to documents filed in federal court.
The DEA says the call never came. Cardinal would not make Moellering available for comment and declined to explain why he never made the call. Cardinal granted Green’s request for more oxycodone but stopped serving the pharmacy a year later.
This month, the DEA accused Cardinal Health, a Fortune 500 company with $103 billion in revenue, of endangering the public by selling excessive amounts of oxycodone to four Florida pharmacies. The charges came in an immediate suspension order served Feb. 3 when the agency suspended Cardinal’s license to distribute controlled substances from its Lakeland, Fla., hub, which serves four states.
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 B150The 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 -->
 |
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 ...
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
US Free Classifieds
Most Popular Online Classifieds in USA. No Sign up, No Email Required to Post.
Canada Free Ads
Free Online Classifieds in Canada.
UK Free Ads
United Kingdom Free Ads Website.
100% Free Ad Posting.Feel that you lost the fine tone and texture of your hair? Constant use of chemical shampoos might have spoilt your hair making it dull and dry. You now need a natural anti-bacterial shampoo for fine and weak hair which does not deprive you the natural nutrients i The Hair & Scalp Doctor - Antibacterial Shampoo is formulated to promote healthy, clean and lustrous hair on itchy and flaky scalps apart from providing deep but gentle cleansing for your hair. The major ingredient Sea buckthorn oil, gives your hair healthy nourishment and selective cleaning.
Our products are available at http://www.facedoctor.ca, Health Armour- http://www.facebook.com/pages/Health-Armour/210485905661974, Turner Drug Store Ltd.- http://www.facebook.com/turnerdrugstore,Simpsons Pharmacy- http://www.facebook.com/pages/Simpsons-Pharmacy/442598165000, and the given store:
Stouffville IDA, 6212 Main St., Stouffville, ON L4A 2S5, phone 905-640-3324, stouffvilleida@rogers.com
Drug companies have taken Oxycontin off pharmacies' shelves and replaced it with a harder alternative called OxyNeo, which is harder to crush or inject.
During Operation Opson (opson translates to "food" in ancient Greek , authorities confiscated more than 13,000 bottles of substandard olive oil, 30 tons of fake tomato sauce, about 77,000 kg. of counterfeit cheese, more than 12,000 bottles of substandard wine, five tons of substandard fish and seafood, nearly 30,000 counterfeit candy bars and investigated fake/substandard caviar being sold via the Internet.
The one-week effort (from November 28 to December 4 involved police, customs agents, regulatory and food-industry officials in airports, seaports, shops and flea markets in Bulgaria, Denmark, France, Hungary, Italy, The Netherlands, Romania, Spain, Turkey and the United Kingdom.
At the time, Simone Di Meo, Criminal Intelligence Officer with Interpol's Intellectual Property Rights program and coordinator for Operation Opson,
said in a news release that counterfeit food is a threat most people are not even aware of, so "one of the main goals of this operation was to protect the public from potentially dangerous fake and substandard food and drinks."
This week in Brussels, food control authorities, police forces, judicial officials and other stakeholders from across the European Union met again to develop strategies for combating food-related crime -- to understand the nature of food counterfeit schemes, to improve detection of these illegal practices and to raise public awareness of the problem to prompt vigilance when shopping.
The conference, held Monday and Tuesday, was part of the EU's Better Training for Safer Food program.
Consumers buying counterfeit goods, either knowingly or unknowingly according to European authorities, put their health at risk because fraudulent foods and beverages are not subject to any manufacturing quality controls and are often transported or stored without regard to safe food-handling standards.
The problem of counterfeit and substandard products is also a concern in the United States, most visible with fake pharmaceuticals, but also with food items. Cheaper types of fish have been passed off as more expensive, such as tilapia being marketed as red snapper or farm-raised salmon being labeled as wild-caught.
According to the U.S. Food and Drug Administration, olive oil is one of the most frequently counterfeited food products -- it is sometimes sold as "extra virgin" when it is actually mostly soybean oil. Honey, maple syrup and vanilla counterfeits have also plagued the U.S. market.
-----------------------
Photo from Interpol-Europol
No comments:
Post a Comment