Category: Pharmaceuticals


Earth Watch Report  –  Biological Hazards

File:Neutrophil and Methicillin-resistant Staphylococccus aureus (MRSA) Bacteria.jpg

 

Scanning electron micrograph of neutrophil ingesting methicillin-resistant Staphylococcus aureus bacteria. Credit: NIAID   National Institutes of Health.

NIAID/NIH

Wikimedia.org

 

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May 13 2014 03:04 AM Biological Hazard Denmark [The area was not defined.] Damage level Details

 

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RSOE EDIS

Biological Hazard in Denmark on Tuesday, 13 May, 2014 at 03:04 (03:04 AM) UTC.

Description
A troubling and also kind of odd story came out of Denmark this weekend. In a court proceeding, a microbiologist has disclosed that three residents of the country who had no known connection to farming died of MRSA infections caused by ST398, the livestock-associated strain of drug-resistant staph that first appeared among pig farmers in the Netherlands in 2004 and has since moved through Europe, Canada and the United States. If the report is correct – and sources have told me it is, but I’ve seen no data to confirm it – it reinforces the concern that bacteria which become resistant because of antibiotic use on farms can move off farms and affect the health of people who have no connection to farming. Livestock MRSA has always one of the best cases for establishing that, because the drug to which it showed the greatest resistance, tetracycline, wasn’t used against human MRSA in the Netherlands, but was used routinely on farms – so the only place the strain could have picked up its unique resistance pattern was in pigs. (Here’s my long archive of posts on pig MRSA, dating back to my book Superbug where the story was told for the first time.) Just to get them high up, here are some Danish news sources; this sees to have been a widely covered story. Danish isn’t one of my languages, so I’ve relied on Google Translate – not the best practice, but there’s enough agreement among the stories that I am comfortable with it in this case.
Biohazard name: MRSA (pig, human)
Biohazard level: 3/4 Hight
Biohazard desc.: Bacteria and viruses that can cause severe to fatal disease in humans, but for which vaccines or other treatments exist, such as anthrax, West Nile virus, Venezuelan equine encephalitis, SARS virus, variola virus (smallpox), tuberculosis, typhus, Rift Valley fever, Rocky Mountain spotted fever, yellow fever, and malaria. Among parasites Plasmodium falciparum, which causes Malaria, and Trypanosoma cruzi, which causes trypanosomiasis, also come under this level.
Symptoms:
Status: confirmed

 

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Denmark: Three Deaths from Drug-Resistant “Pig MRSA”

ICStefanescu (CC), Flickr

A troubling and also kind of odd story came out of Denmark this weekend. In a court proceeding, a microbiologist has disclosed that three residents of the country who had no known connection to farming died of MRSA infections caused by ST398, the livestock-associated strain of drug-resistant staph that first appeared among pig farmers in the Netherlands in 2004 and has since moved through Europe, Canada and the United States.

If the report is correct — and sources have told me it is, but I’ve seen no data to confirm it — it reinforces the concern that bacteria which become resistant because of antibiotic use on farms can move off farms and affect the health of people who have no connection to farming.

Livestock MRSA has always one of the best cases for establishing that, because the drug to which it showed the greatest resistance, tetracycline, wasn’t used against human MRSA in the Netherlands, but was used routinely on farms — so the only place the strain could have picked up its unique resistance pattern was in pigs. (Here’s my long archive of posts on pig MRSA, dating back to my book Superbug where the story was told for the first time.)

Just to get them high up, here are some Danish news sources; this sees to have been a widely covered story. Danish isn’t one of my languages, so I’ve relied on Google Translate — not the best practice, but there’s enough agreement among the stories that I am comfortable with it in this case.

  • The Information: “Filthy use of antibiotics”
  • Kvalls Posten: “Resistant swine bacterium has killed three Danes”
  • DR DK: “Politicians are worried about swine bacteria”
  • Avisen: “Three Danes die of swine bacteria”
  • Ekstra Bladet: “Three died from killer bacteria from pigs”
  • Fyens: “University hospital physician: Three died of swine bacteria”

 

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Antibiotic resistance now ‘global threat’, WHO warns

Lab research into new antibiotics WHO called for more preventative measures against infection

It analysed data from 114 countries and said resistance was happening now “in every region of the world”.

It described a “post-antibiotic era”, where people die from simple infections that have been treatable for decades.

There were likely to be “devastating” implications unless “significant” action was taken urgently, it added.

The report focused on seven different bacteria responsible for common serious diseases such as pneumonia, diarrhoea and blood infections.

It suggested two key antibiotics no longer work in more than half of people being treated in some countries.

What we urgently need is a solid global plan of action which provides for the rational use of antibiotics”

Dr Jennifer Cohn Medecins sans Frontiers

One of them – carbapenem – is a so-called “last-resort” drug used to treat people with life-threatening infections such as pneumonia, bloodstream infections, and infections in newborns, caused by the bacteria K.pneumoniae.

Bacteria naturally mutate to eventually become immune to antibiotics, but the misuse of these drugs – such as doctors over-prescribing them and patients failing to finish courses – means it is happening much faster than expected.

The WHO says more new antibiotics need to be developed, while governments and individuals should take steps to slow the process of growing resistance.

In its report, it said resistance to antibiotics for E.coli urinary tract infections had increased from “virtually zero” in the 1980s to being ineffective in more than half of cases today.

In some countries, it said, resistance to antibiotics used to treat the bacteria “would not work in more than half of people treated”.

 

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Antibiotic resistance: 6 diseases that may come back to haunt us

Still think of TB, typhoid and gonorrhoea as infections from the past? WHO’s terrifying report will make you think again
Neisseria gonorrhoeae, the bacteria that causes the sexually transmitted disease gonorrhoea

Neisseria gonorrhoeae, the bacteria that causes the sexually transmitted disease gonorrhoea. Photograph: Dr. David M. Phillips/Getty Images/Visuals Unlimited

Diseases we thought were long gone, nothing to worry about, or easy to treat could come back with a vengeance, according to the recent World Health Organisation report on global antibiotic resistance. Concern at this serious threat to public health has been growing; complacency could result in a crisis with the potential to affect everyone, not just those in poor countries or without access to advanced healthcare. Already diseases that were treatable in the past, such as tuberculosis, are often fatal now, and others are moving in the same direction. And the really terrifying thing is that the problem is already with us: this is not science fiction, but contemporary reality. So what are some of the infections that could come back to haunt us?

Tuberculosis

TB ought to be treatable within six months once people are prescribed a course of drugs including the once potent antibiotics isoniazid and rifampicin. But today, resistance has emerged not only to these medicines, but to the wider range of pharmaceuticals used to treat the disease. This has led to the emergence of multi-drug-resistant TB, the still less treatable extensively drug-resistant TB (XDR-TB), and even to total drug-resistant TB, which has only officially been confirmed in India. Countries such as South Africa have run out of treatment options for many of their patients and are having to discharge them from hospital. Resistance to TB has reached a global scale with XDR-TB now reported in 92 countries.

Gonorrhoea

The sexually transmitted nature of this infection makes it something many are reluctant to talk about or admit to having. However, it’s long been thought of as easily treatable and nothing much to fear. Once fixable with penicillin and tetracycline, the bacteria behind the disease have developed such high levels of resistance that there is only one drug left that can treat it. Even this antibiotic, ceftriaxone, is becoming less effective. With last-resort drugs losing their impact, this sexually transmitted infection (STI) could spread throughout the population.

Klebsiella

It’s likely that you’ve never heard of this common bacterium, which can cause a wide range of conditions including pneumonia, urinary tract infections, septicaemia, meningitis and diarrhoea. It fits into a wider group of bacteria with the apt acronym of Eskape owing to their ability to avoid the effects of the antibiotics used against them. The acronym stands for the names of the bacterial group members: Enterococcus faecium; Staphylococcus aureus; Klebsiella pneumoniae; Acinetobacter baumannii; Pseudomonas aeruginosa; and Enterobacter. Klebsiella and the rest of this group are increasingly being acquired in hospitals. While we fear MRSA, it is in fact a declining threat in hospitals; at the same time Eskape pathogens are causing more and more problems. As the WHO report highlighted, routine hospital visits or treatments could result in these previously treatable bacteria having fatal consequences.

 

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Food Poisoning Bulletin

lifefit-recallLifeFit dietary supplement is being recalled because it contains an undeclared controlled substance that was banned in 2010 for safety reasons. Consumers who have purchased this product should not use it as it poses a serious health threat.

Bacai, LifeFit’s distrbuter, is voluntarily recalling the product sold in plastic bottles of 30 softgels with the lot number 13165. The lot number is located next to the expiration date May 2017. It was distributed worldwide to wholesalers, retailers, and through the internet.

An analysis by the U.S. Food and Drug Administration (FDA) found that the product contains sibutramine, which causes substantial increase in blood pressure and/or pulse rate. This can pose a  in significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. The drug can also cause a life-threatening situation if taken with other medications.

 

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Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events

[Posted 10/08/2010]

AUDIENCE: Primary Care, Consumers

ISSUE: Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary withdrawal of Meridia (sibutramine), an obesity drug, from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.

BACKGROUND: Meridia was approved November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone. FDA has now requested market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT is part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of the drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared with another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.

RECOMMENDATION: Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.

 

[10/08/2010 – Drug Safety Communication – FDA]
[10/08/2010 – Questions and Answers – FDA]
[10/08/2010 – News Release – FDA]

Previous MedWatch Alert:

[01/21/2010 – Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review]

 

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Lives ‘left in ruin’ by rising tide of depression drugs

More people are being put on the pills but some experts are now warning they do more harm than good. Julia Llewellyn Smith reports

Jo Thompson

Jo Thompson ended up in hospital on anti-anxiety pills, and wanted to die when she stopped them  Photo: Geoff Pugh/Telegraph

Twenty years ago, Henry was living a fulfilled life. A happily married father from the Home Counties, his sales career was going well, he had a wide social circle and played football and golf regularly. “I was a conservative, head-down, career-minded person who enjoyed my life,” he says.

But in 1995, a bout of flu left Henry, then 31, exhausted and lethargic. He visited his GP, who told him he was depressed, and prescribed the world’s most popular antidepressant, Prozac. “Everything appeared completely benign — he said depression was a common complaint, the drugs would fix it and then I’d stop taking them.”

More than a decade later, Henry was far from cured and still taking antidepressants. “None of the drugs I was prescribed made me feel better, and most made me considerably worse. But every time I stopped them, the symptoms of what I thought was depression — but now know were of withdrawal — returned even more strongly, so I went back to the pills.”

By 2009, he was so unwell that he had to give up work. Finally, suspecting the drugs were the cause of his problems, he quit them, only to enter a new hell.

“It was torture. I thought I was going to die, and I didn’t care. For two years, I was in severe physical pain and so weak I lay all day on the sofa. My cognition was severely affected, I was dizzy, with blurred vision, I couldn’t read a bedtime story to my son and couldn’t remember things that had happened just a few seconds previously.”

Henry — who does not want to reveal his last name because of pending legal action against the drugs manufacturers — is just one of an estimated four million people in Britain taking antidepressants, a number that is rising sharply.

Last year, 53 million prescriptions were issued for antidepressants in England alone, nearly double the number prescribed a decade ago, and a six per cent increase in the past year. According to recent research, one in three British women and one in 10 men now take the medication, including popular brands such as Prozac, Cipramil and Seroxat, at some point in their lives.

But a growing number of experts now believe depression is vastly overdiagnosed and the drugs can cause far more harm than good.

This week, a new organisation, the Council for Evidence-Based Psychiatry (CEP), whose members include psychiatrists, academics and withdrawal charities, is launching, to educate the public about the risks of antidepressants. A keynote speech will be given by Prof Peter Gøtzsche, co-founder of the Cochrane Collaboration, an international, non-profit organisation that examines vast amounts of medical data to help doctors and patients reach informed conclusions about health.

 

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Over 250 million Americans are addicted to ‘food drugs’ and suffering the consequences

Monday, April 21, 2014 by: S. D. Wells

 

food

(NaturalNews) What? — Food drugs? What on Earth are you talking about? Do you mean “they,” as in “Big Food,” are putting prescription drugs inside food and drinks? Do you mean that scientists are working in labs right now figuring out how to make humans addicted to certain food additives and agents? Is that what you mean by food drugs? Health enthusiasts everywhere want to know.

The Health Ranger is studying this phenomenon in the Natural News Forensic Food Lab — using microscopy and other high-tech scientific equipment for measuring chemical levels in foods, including toxic heavy metals like lead, cadmium and aluminum. Do you ever wonder how many chemicals are in foods? Try about 70,000 different ones that are allowed by the FDA! How can you even start to filter them out of your daily intake? That’s easy. You just have to prioritize. Start with identifying and eliminating toxic heavy metals and pesticides, the two largest contributors to disease and disorder in the U.S. of A. (http://www.organicconsumers.org)

Junk Science Addicts Galore

What is junk science? Who invests in it? Who is responsible for this insidious development?
(http://www.naturalnews.com)

Why does the Biotech Industry and the late great healthcare scam of Obamacare want you addicted to junk food? What is the big picture and what is the grand connection here? Do they bioengineer aspartame (central nervous system disruptor) and MSG (another CNS disruptor) to make you hungrier and make you gain weight? Yes. They do. And do they bioengineer bug killer and weed killer to ruin your good gut bacteria, your flora? Yes.

How can you become addicted to McDonald’s and Taco Bell for life? How are GMO potato chips and HFCS (high fructose corn syrup) subsidized by the Government, and why would they subsidize sickness? These questions and more are all answered, and all you have to do to learn is keep your mind open about your own health.

Over 250 million Americans are addicted right now to FOOD DRUGS and suffering health consequences — heading directly toward cancer, diabetes, Alzheimer’s and arthritis. Let’s face it, Big Food invests mainly in one area, and that is Big Pharma. Conventional food (90% of all food) is processed and cooked DEAD and then labeled as “fortified” to fool the public that it contains any nutritional value at all, when it doesn’t.

Plus, since about 1990, the holiness of natural food has been devastated by genetic modification — to contain weed killer and bug killer, so on top of being dead food, for two decades it has been contaminated with poison on the inside. The seeds and plants now contain chemicals that kill pests, and guess what the human beings are who consume them? — Dying “pests!” Ca-ching! — Big money for the pink-ribbon-washing cancer-industrial complex. Don’t be a fool. Stop getting fooled. It’s okay to admit when you are wrong. Go on, open the doors of your pantry and look. Open that refrigerator and freezer. Open your medicine cabinet. It’s time to throw away everything that Big Food and Big Pharma have “sold you” through false advertising and marketing schemes.

 

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ScienceDaily: Your source for the latest research news

Hepatitis C treatment cures over 90 percent of patients who also have cirrhosis

Date:
April 12, 2014
Source:
University of Texas Health Science Center at San Antonio
Summary:
Twelve weeks of an investigational oral therapy cured hepatitis C infection in more than 90 percent of patients with liver cirrhosis and was well tolerated by these patients, according to a new study.

Twelve weeks of an investigational oral therapy cured hepatitis C infection in more than 90 percent of patients with liver cirrhosis and was well tolerated by these patients, according to an international study that included researchers from UT Medicine San Antonio and the Texas Liver Institute. Historically, hepatitis C cure rates in patients with cirrhosis (liver scarring) have been lower than 50 percent and the treatment was not safe for many of these patients.

Hepatitis C virus is the No. 1 driver of cirrhosis, liver transplants and liver cancer in the United States, noted Fred Poordad, M.D., lead author on the study, which was released Saturday by The New England Journal of Medicine in conjunction with Dr. Poordad’s presentation of the data at the International Liver Congress in London. UT Medicine is the clinical practice of the School of Medicine at The University of Texas Health Science Center at San Antonio, where Dr. Poordad is a professor of medicine. He is vice president of the Texas Liver Institute in San Antonio.

Interferon previously was the only agent to show effectiveness against hepatitis C, but patients often relapsed and the therapy caused multiple side effects. The new regimen is interferon-free and consists of several agents — ABT-450/ritonavir, ombitasvir, dasabuvir and ribavirin. Twelve weeks after the last dose, no hepatitis C virus was detected in the bloodstream of 91.8 percent of patients who took the pills for 12 weeks. Among patients treated for 24 weeks, 95.9 percent were virus-free 12 weeks after the end of therapy.

 

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 Combination Drug Therapy Amazingly Effective In Tackling Hepatitis C

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ScienceDaily: Your source for the latest research news

 

New combination drug therapy proves very effective in hepatitis C treatments

Date:
April 12, 2014
Source:
Beth Israel Deaconess Medical Center
Summary:
Treatment options for the 170 million people worldwide with chronic Hepatitis C Virus (HCV) are evolving rapidly, although the available regimens often come with significant side effects. Two multi-center clinical trials show promise for a new option that could help lead to both an increase in patients cured with a much more simple and tolerable all oral therapy.

Treatment options for the 170 million people worldwide with chronic Hepatitis C Virus (HCV) are evolving rapidly, although the available regimens often come with significant side effects. Two multi-center clinical trials led by Beth Israel Deaconess Medical Center show promise for a new option that could help lead to both an increase in patients cured with a much more simple and tolerable all oral therapy.

A new 12-week single tablet regimen of ledipasvir and sofosbuvir have proven to be highly effective in treating a broad range of patients with HCV genotype 1, a form of the virus found in up to 75 percent of infections, according to results unveiled today at the European Association for the Study of the Liver and published simultaneously online by the New England Journal of Medicine.

Between 94 percent and 99 percent of patients were cured of hepatitis C and results were similar in patients who have never been treated and for those who had previously been treated with a combination of peginterferon and ribavirin, the current course that carries sometimes significant side effects.

“Eliminating interferon and ribavirin from treatment regimens is expected to reduce the incidence and severity of adverse events, to simplify the treatment of patients with HCV infection and to provide an option for patients who are ineligible for the current interferon-based treatments,” said Nezam Afdhal, MD, the senior author of the studies, Director of the Liver Center at Beth Israel Deaconess Medical Center and a Professor of Medicine at Harvard Medical School.

Hepatitis C is an infectious disease primarily affecting the liver and which can lead to scarring and cirrhosis and is transmitted primarily through blood transfusions (prior to 1991), intravenous drug use, poorly sterilized medical equipment and sexual transmission.. After exposure 80 percent of patients develop a chronic hepatitis which can lead to cirrhosis, liver failure and liver cancer and hepatitis C is the most common cause for liver transplantation in the US.

Prior treatments have been with interferon which is an injectable cytokine released in response to viral infections. Interferon is combined with other antiviral agents and needs to be used for up to 48 weeks to cure hepatitis C. but is associated with number of side effects, including influenza-like symptoms depression and anemia. Many patients are ineligible for these interferon-based therapies.

“The real advances seen in the Ion trials is that the sofosbuvir-ledipasvir combination tablet enables us to treat almost all genotype 1 patients with a short duration of 8-12 weeks of treatment expanding the treatment pool and increasing the overall cure rate,” said Afdhal.

Recent recommendations by the CDC and endorsed by the USPHS Task force have recommended screening of baby boomers (persons born between 1945 and 1965) for hepatitis C since up to3 percent may have silent infection without symptoms.
“Screening for HCV needs to be associated with a safe and effective treatment for these “baby boomers” with newly identified HCV and the ION trials clearly give an exciting new option for these patients” stated Afdhal.

 

 

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What the Tamiflu saga tells us about drug trials and big pharma

We now know the government’s Tamiflu stockpile wouldn’t have done us much good in the event of a flu epidemic. But the secrecy surrounding clinical trials means there’s a lot we don’t know about other medicines we take

Tamiflu capsules

Tamiflu capsules. Photograph: Per Lindgren/REX

Today we found out that Tamiflu doesn’t work so well after all. Roche, the drug company behind it, withheld vital information on its clinical trials for half a decade, but the Cochrane Collaboration, a global not-for-profit organisation of 14,000 academics, finally obtained all the information. Putting the evidence together, it has found that Tamiflu has little or no impact on complications of flu infection, such as pneumonia.

That is a scandal because the UK government spent £0.5bn stockpiling this drug in the hope that it would help prevent serious side-effects from flu infection. But the bigger scandal is that Roche broke no law by withholding vital information on how well its drug works. In fact, the methods and results of clinical trials on the drugs we use today are still routinely and legally being withheld from doctors, researchers and patients. It is simple bad luck for Roche that Tamiflu became, arbitrarily, the poster child for the missing-data story.

And it is a great poster child. The battle over Tamiflu perfectly illustrates the need for full transparency around clinical trials, the importance of access to obscure documentation, and the failure of the regulatory system. Crucially, it is also an illustration of how science, at its best, is built on transparency and openness to criticism, because the saga of the Cochrane Tamiflu review began with a simple online comment.

In 2009, there was widespread concern about a new flu pandemic, and billions were being spent stockpiling Tamiflu around the world. Because of this, the UK and Australian governments specifically asked the Cochrane Collaboration to update its earlier reviews on the drug. Cochrane reviews are the gold-standard in medicine: they summarise all the data on a given treatment, and they are in a constant review cycle, because evidence changes over time as new trials are published. This should have been a pretty everyday piece of work: the previous review, in 2008, had found some evidence that Tamiflu does, indeed, reduce the rate of complications such as pneumonia. But then a Japanese paediatrician called Keiji Hayashi left a comment that would trigger a revolution in our understanding of how evidence-based medicine should work. This wasn’t in a publication, or even a letter: it was a simple online comment, posted informally underneath the Tamiflu review on the Cochrane website, almost like a blog comment.

Tamiflu being made by Roche The UK government spent £0.5bn stockpiling Tamiflu. Photograph: Hanodut/EPA

Cochrane had summarised the data from all the trials, explained Hayashi, but its positive conclusion was driven by data from just one of the papers it cited: an industry-funded summary of 10 previous trials, led by an author called Kaiser. From these 10 trials, only two had ever been published in the scientific literature. For the remaining eight, the only available information on the methods used came from the brief summary in this secondary source, created by industry. That’s not reliable enough.

This is science at its best. The Cochrane review is readily accessible online; it explains transparently the methods by which it looked for trials, and then analysed them, so any informed reader can pull the review apart, and understand where the conclusions came from. Cochrane provides an easy way for readers to raise criticisms. And, crucially, these criticisms did not fall on deaf ears. Dr Tom Jefferson is the head of the Cochrane respiratory group, and the lead author on the 2008 review. He realised immediately that he had made a mistake in blindly trusting the Kaiser data. He said so, without defensiveness, and then set about getting the information needed.

First, the Cochrane researchers wrote to the authors of the Kaiser paper. By reply, they were told that this team no longer had the files: they should contact Roche. Here the problems began. Roche said it would hand over some information, but the Cochrane reviewers would need to sign a confidentiality agreement. This was tricky: Cochrane reviews are built around showing their working, but Roche’s proposed contract would require them to keep the information behind their reasoning secret from readers. More than this, the contract said they were not allowed to discuss the terms of their secrecy agreement, or publicly acknowledge that it even existed. Roche was demanding a secret contract, with secret terms, requiring secrecy about the methods and results of trials, in a discussion about the safety and efficacy of a drug that has been taken by hundreds of thousands of people around the world, and on which governments had spent billions. Roche’s demand, worryingly, is not unusual. At this point, many in medicine would either acquiesce, or give up. Jefferson asked Roche for clarification about why the contract was necessary. He never received a reply.

Then, in October 2009, the company changed tack. It would like to hand over the data, it explained, but another academic review on Tamiflu was being conducted elsewhere. Roche had given this other group the study reports, so Cochrane couldn’t have them. This was a non-sequitur: there is no reason why many groups should not all work on the same question. In fact, since replication is the cornerstone of good science, this would be actively desirable.

Then, one week later, unannounced, Roche sent seven documents, each around a dozen pages long. These contained excerpts of internal company documents on each of the clinical trials in the Kaiser meta-analysis. It was a start, but nothing like the information Cochrane needed to assess the benefits, or the rate of adverse events, or fully to understand the design of the trials.

Packets of Tamiflu Packets of Tamiflu in a drawer at a German pharmacy. Photograph: Wolfgang Rattay/Reuters At the same time, it was rapidly becoming clear that there were odd inconsistencies in the information on this drug. Crucially, different organisations around the world had drawn vastly different conclusions about its effectiveness. The US Food and Drug Administration (FDA) said it gave no benefits on complications such as pneumonia, while the US Centers for Disease Control and Prevention said it did. The Japanese regulator made no claim for complications, but the European Medicines Agency (EMA) said there was a benefit. There are only two explanations for this, and both can only be resolved by full transparency. Either these organisations saw different data, in which case we need to build a collective list, add up all the trials, and work out the effects of the drug overall. Or this is a close call, and there is reasonable disagreement on how to interpret the trials, in which case we need full access to their methods and results, for an informed public debate in the medical academic community.

This is particularly important, since there can often be shortcomings in the design of a clinical trial, which mean it is no longer a fair test of which treatment is best. We now know this was the case in many of the Tamiflu trials, where, for example, participants were sometimes very unrepresentative of real-world patients. Similarly, in trials described as “double blinded” – where neither doctor nor patient should be able to tell whether they’re getting a placebo or the real drug – the active and placebo pills were different colours. Even more oddly, in almost all Tamiflu trials, it seems a diagnosis of pneumonia was measured by patients’ self-reporting: many researchers would have expected a clear diagnostic algorithm, perhaps a chest x-ray, at least.

Since the Cochrane team were still being denied the information needed to spot these flaws, they decided to exclude all this data from their analysis, leaving the review in limbo. It was published in December 2009, with a note explaining their reasoning, and a small flurry of activity followed. Roche posted their brief excerpts online, and committed to make full study reports available. For four years, they then failed to do so.

 

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Row erupts over influenza drug Tamiflu

Tamiflu is on the World Health Organisation's 'essential medicines' list (Flickr: kanonn)

Tamiflu is on the World Health Organisation’s ‘essential medicines’ list (Flickr: kanonn)

Governments who stockpile the anti-flu medicine Tamiflu are wasting billions of dollars on a drug whose effectiveness is in doubt, according to a new study.

The row has drawn in the drugmaker Roche, as well as industry regulators and independent scientists. Supporters of Tamiflu says the review’s conclusions are flawed and insiste the drug is both safe and effective.

The dispute over the benefits of Tamiflu, and to a lesser extent of GlaxoSmithKline’s flu drug Relenza, blew up with the joint publication by the respected Cochrane Review research network and the British Medical Journal of an analysis of trial data, which found no good evidence behind claims the drugs cut hospital admissions or reduce flu complications.

The review’s main findings were that the medicines had few if any beneficial effects, but did have adverse side effects that were previously dismissed or overlooked.

“Remember, the idea of a drug is that the benefits should exceed the harms,” says Carl Heneghan, one of the lead investigators of the Cochrane review and a professor of evidence-based medicine at Britain’s Oxford University. “So if you can’t find any benefits, that accentuates the harms.”

But Roche, which has been under fire for several years over its refusal to allow the Cochrane team unrestricted access to Tamiflu data, rejected the findings, saying it “fundamentally disagrees with the overall conclusions” of their study.

“We firmly stand by the quality and integrity of our data, reflected in decisions reached by 100 regulators across the world and subsequent real-world evidence demonstrating that Tamiflu is an effective medicine in the treatment and prevention of influenza,” it says in a statement.

Tamiflu sales hit almost $3 billion in 2009 — mostly due to its use in the H1N1 flu pandemic — but they have since declined.

The drug, one of a class of medicines known as neuraminidase inhibitors, is approved by regulators worldwide and is stockpiled in preparation for a potential global flu outbreak. It is also on the World Health Organisation’s “essential medicines” list.

 

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young sick Americans Living Sick and Dying Young in Rich America

 

Health Impact News Editor Comments

When I read an article in The Atlantic recently with the title: Living Sick and Dying Young in Rich America – Chronic illness is the new first-world problem – it caught my attention. This is the kind of topic we cover on a regular basis here at Health Impact News, but seldom do you read about it in the mainstream media.

There are 3 things that are rather astonishing about the sad state of health in America today:

1. We’re sicker than previous generations, and most of us know it.

2. We don’t seem to care about it too much. It is not headline news.

3. There doesn’t seem to be much motivation to change this fact: it seems to have been accepted as the new “norm.”

Last year, we reported about a study funded by the government and your tax dollars which clearly showed that the United States ranks #1 on healthcare spending, but last in life expectancy among wealthy nations (See: U.S. Ranks First in Healthcare Spending – Last in Life Expectancy). The mainstream media barely even covered this story, and even here at Health Impact News it was probably not even in the top 100 stories read from everything we published last year.

The sad fact seems to be that most Americans have adopted an attitude that the current health situation in the U.S. cannot be changed.

For those few of you who have not drunk the Kool Aid, and still believe you do have control over your health and have choices you can make to live a healthier life, then this article by John Thomas identifying the problems and solutions is for you.

Please understand that if enough Americans understand that the healthcare system (which is not really a “healthcare” system at all but a MEDICAL system) is the primary problem and take measures to avoid it, that it would absolutely destroy our economy, since so much of it is dependent on sick people. But maybe our economy is heading for destruction anyway, so don’t let that threat stop you from making healthy choices today.

Is it Normal to be Sick?

by John P. Thomas

Is it normal to be sick? Many people think so, but it hasn’t always been this way. What was life like before we became dependent on modern pharmaceutical drugs, major medical centers, and health insurance? If we turn back the clock a hundred and fifty years, we will hardly find anything that looks like the modern medical system. Did previous generations live in the dark ages of medicine, or is the modern age of chronic degenerative illness and modern pharmaceutical drugs actually a dark age of medicine?

I remember overhearing a conversation while waiting for a table in a restaurant some 25 years ago. A grandmother was talking to her 10 year old grandson. She must not have seen him for a while, so she began by asking one of those general types of questions to get the conversation started. “How are you feeling?” Without hesitation, her grandson started discussing his various health problems, which included allergies, asthma, fatigue, etc. In a grandmotherly voice filled with sympathy and concern, she gave a reply that sticks in my mind to this day.  She said, “I understand — we all have something wrong with us.” She went on to tell him that we are all sick and we have to learn to live with it. I don’t know if her words were entirely true then, but they are most certainly true today! We are sick and getting sicker, and we are all being taught to live with it.

Here we are 25 years later and despite all the medical and pharmaceutical advances that have taken place in the United States, we are sicker than ever. How many people do you know who are not taking one or more prescription medications? How many people do you know who do not have a medical diagnosis for some chronic illness? How many people do you know who are not being treated for some condition that requires periodic trips to the doctor to monitor disease progression and to adjust medications? How many people do you know who struggle with paying for medications? If I count the people I know, who do not fall into the groups I just mentioned, I can count them on the fingers of one hand. How about the people you know?

The purpose of this article is to examine how we respond to our illnesses and to questions whether our pharmaceutical drugs and system of healthcare is making us sicker than we need to be.

Does the Healthcare System in the United States Lead the World?

We certainly lead the world in the amount of dollars spent on healthcare. We spend 2.5 times more per person per year than is spent in any other country on Earth for healthcare.1

Does the Money we Spend for Healthcare Make Us the Healthiest people in the World?

The New York Times recently revealed how our healthcare system compares to other countries.

“In the Social Progress Index, the United States excels in access to advanced education but ranks 70th in health, 69th in ecosystem sustainability, 39th in basic education, 34th in access to water and sanitation and 31st in personal safety.”2

The United States is sitting in the 70th position down from the top of the list for the category of health when compared to other countries. Let’s look at the details of how we compare to other wealthy countries.

The Panel on Understanding Cross-National Health Differences Among High-Income Countries, compared the health of people living in the United States with people living in other high income countries, which included Australia, Austria, Canada, Denmark, Finland, France, Germany, Italy, Japan, Norway, Portugal, Spain, Sweden, Switzerland, the Netherlands, and the United Kingdom. They reported:

Over this time period, we uncovered a strikingly consistent and pervasive pattern of higher mortality and inferior health in the United States, beginning at birth: … For many years, Americans have had a shorter life expectancy than people in almost all of the peer countries. For example, as of 2007, U.S. males lived 3.7 fewer years than Swiss males and U.S. females lived 5.2 fewer years than Japanese females.3

We have the most expensive healthcare system in the world, which should make us the healthiest people on Earth, but this is not the case.

Why are We so Sick?….

 

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Expensive pills
March 29, 2014

There is a little known bill in the works which would force people in crisis into forced psychiatric treatment. Mad in America reported on March 28, 2014 that mental health advocates are urging protest against a forced treatment addition to a new Medicare bill. Many national mental health and disability advocacy groups have joined together to urge people to contact their senators in order to protest a section of a bill which was rushed through the House of Representatives by voice vote this week. This bill, Section 224 of HR4302, is up for a vote in the Senate on Monday.

Raymond Bridge, public policy director of the National Coalition for Mental Health Recovery has said: “In its rush to fix a problem with Medicare, the House passed a bill including a highly controversial program, involuntary outpatient commitment, with no debate and no roll call vote.” It appears to Bridge that the Senate may pass a version of the House bill which includes this troublesome provision on Monday. Daniel Fisher, M.D., Ph.D. has commented about this bill, saying: “It would bring America back to the dark ages before de-institutionalization, when people with mental health conditions languished in institutions, sometimes for life.”

Read More Here

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Mental Health Advocates Decry Forced Treatment Provision in “Doc Fix” Bill

 

WASHINGTON, March 28, 2014 /PRNewswire-USNewswire/ — The bill rushed through the House of Representatives by voice vote yesterday to patch Medicare regulations includes a highly controversial provision that has nothing to do with Medicare, and that would subject people in crisis to forced treatment. Studies have shown that such force causes trauma and drives people away from treatment, mental health advocates warned.

Today, an array of national mental health and disability advocacy groups joined together to decry this provision, which they view as a regressive attack on hundreds of thousands of Americans with serious mental health conditions.

“In its rush to fix a problem with Medicare, the House passed a bill including a highly controversial program, involuntary outpatient commitment, with no debate and no roll call vote,” said Raymond Bridge, public policy director of the National Coalition for Mental Health Recovery (NCMHR), a coalition of 32 statewide organizations and others representing individuals with mental illnesses. “And it seems that the Senate may pass a version of the House bill including this troubling provision on Monday,” Bridge added.

The 123-page Protecting Access to Medicare Act of 2014, H.R. 4302, includes a four-year, $60 million grant program (Sec. 224) to expand involuntary outpatient commitment (IOC) – also called Assisted Outpatient Treatment (AOT) – in states that have laws authorizing IOC. The laws allow courts to mandate someone with a serious mental illness to follow a specific treatment plan, usually requiring medication. The facts show that involuntary outpatient commitment is not effective, involves high costs with minimal returns, is not likely to reduce violence, and that there are more effective alternatives.

Assisted Outpatient Treatment is central to the controversial Helping Families in Mental Health Crisis Act (H.R. 3717), proposed by Rep. Tim Murphy in December 2013.

“This legislation would eliminate initiatives that use evidence-based, voluntary, peer-run services and family supports to help people diagnosed with serious mental illnesses to recover,” said Daniel Fisher, M.D., Ph.D., a psychiatrist and an NCMHR founder. “It would bring America back to the dark ages before de-institutionalization, when people with mental health conditions languished in institutions, sometimes for life.”

The provisions of H.R. 3717 would exchange low-cost, community-based services with good outcomes for high-cost yet ineffective interventions, according to the NCMHR; the National Disability Rights Network (NDRN), the non-profit membership organization for the federally mandated Protection and Advocacy (P&A) Systems and Client Assistance Programs (CAP) for individuals with disabilities; and the National Council on Independent Living (NCIL), which advances independent living and the rights of people with disabilities through consumer-driven advocacy.

 

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