Flu vaccine efficacy (CIDRAP study findings)

[Master Shake]

Executive summary here

http://www.cidrap.umn.edu/cidrap/fil...ec_summary.pdf

The money quotes? (Note TIV is trivalent inactivated influenza vaccine (shot), LAIV is live attenuated influenza vaccine (mist))

"We reviewed all studies that evaluated influenza
vaccine efficacy and effectiveness published from 1967
to 2012 and summarized those that used rigorous
methodology and had specific infection outcome end
points.

For TIV, results demonstrated: (1) evidence of
moderate protection (pooled estimate of 59%) for
healthy adults 18 to 64 years of age, (2) inconsistent
evidence of protection in children age 2 to 17 years,
and (3) a paucity of evidence for protection in adults 65
years of age and older.

For LAIV, results demonstrated:
(1) evidence of high protection (pooled estimate of
83%) for young children 6 months to 7 years of age,
(2) inconsistent evidence of protection in adults 60
years of age and older, and (3) a lack of evidence for
protection in individuals between 8 and 59 years of
age."

Interpretation

Flu mist is effective for young (0.5 - 7 years) children. Mist and shots are slightly better than coin flips, if that, for other sub-popuations.

[shiny!]

Re: Flu vaccine efficacy (CIDRAP study findings)

Interesting article.

Since I started taking Vitamin D about six years ago, I stopped getting flu shots and haven't gotten the flu even once. I used to get the flu almost every year. I take 8000-10,000 IU of D3 daily. Some people believe that catching the flu is actually a symptom of vitamin D deficiency, like scurvy comes from vitamin C deficiency.

[mooncliff]

Re: Flu vaccine efficacy (CIDRAP study findings)

I have been taking vitamin D at around 5,000 iu per day, and I also seem to have many fewer colds and have not had the flu since. I also try to go outside and pull weeds for 10 minutes a day and walk on the sunny side of the street in the winter.

That kind of efficacy for vaccines is fairly typical. 50% of people vaccinated may avoid getting the flu. 25% of people may have reduced symptoms. No effect for 25%.
Even the highest realistic targets for vaccines is 70%.
However, while not everyone will be immune, if half of people are resistant, it acts like a firebreak and will prevent the disease from becoming epidemic.
In the best cases, we can actually eliminate the disease from the wild, as was done with small pox, and we are close to doing it with polio, but political problems are getting in the way.
It may possibly in the future to produce vaccines that are 99% effective by 1) injecting the vaccine in many small short needles in a patch so that the vaccine is delivered near the epidermis where most of the white blood cells are instead of injecting the vaccine deeply, and 2) mixing very small amounts of diabetes medication with the vaccine, thereby activating white blood cells. It seems fasting before getting a vaccination may also make the vaccine more effective.
There were times when flu vaccine was given to children in Japan, and the death rate plummeted. Children carry the flu home give it to their parents and the elderly, so it might be more effective to vaccinate children rather than the elderly, who tend to have poor response to vaccines. So, if you are in your 50s, it might be worth considering all the vaccines you need, like shingles, pneumonia, etc., and getting them sooner rather than later.

[Chris Coles]

Re: Flu vaccine efficacy (CIDRAP study findings)

I am like Shiny! and Mooncliff, I take my Vitamin D3 and do not get the flu any more.

[EJ]

Re: Flu vaccine efficacy (CIDRAP study findings)

I have been taking vitamin D at around 5,000 iu per day, and I also seem to have many fewer colds and have not had the flu since. I also try to go outside and pull weeds for 10 minutes a day and walk on the sunny side of the street in the winter.

That kind of efficacy for vaccines is fairly typical. 50% of people vaccinated may avoid getting the flu. 25% of people may have reduced symptoms. No effect for 25%.
Even the highest realistic targets for vaccines is 70%.
However, while not everyone will be immune, if half of people are resistant, it acts like a firebreak and will prevent the disease from becoming epidemic.
In the best cases, we can actually eliminate the disease from the wild, as was done with small pox, and we are close to doing it with polio, but political problems are getting in the way.
It may possibly in the future to produce vaccines that are 99% effective by 1) injecting the vaccine in many small short needles in a patch so that the vaccine is delivered near the epidermis where most of the white blood cells are instead of injecting the vaccine deeply, and 2) mixing very small amounts of diabetes medication with the vaccine, thereby activating white blood cells. It seems fasting before getting a vaccination may also make the vaccine more effective.
There were times when flu vaccine was given to children in Japan, and the death rate plummeted. Children carry the flu home give it to their parents and the elderly, so it might be more effective to vaccinate children rather than the elderly, who tend to have poor response to vaccines. So, if you are in your 50s, it might be worth considering all the vaccines you need, like shingles, pneumonia, etc., and getting them sooner rather than later.

My Uncle Herbert was a doctor for the VA system in Texas and Oklahoma for over 40 years. He lived out his final years until age 89 in a home in San Antonio where I visited him every chance I got. On one visit he noted the number of his contemporaries had died of the flu that year. I asked if he took flu shots. He said had had religiously every year since he was in his 50s and owed his avoidance of flu to it. He explained that while the formula for any one year's vaccine may or may not be a close match the actual flu strain for that year, over many years you accumulate a vast array of influenza antibodies. One of them is bound to be close enough to any one year's strain that worst case you only get slightly ill and best case you never get sick at all, as was his experience.

Another story. My friend David has been getting a flu shot every year since he turned 50 when he caught the flu and got so sick that at one point his fingertips turned blue. He'd always been healthy and the severity of the illness shocked him.

Flu hits you harder as you get older. By the time you're in your 70s it's no joke. I plan to keep building my influenza antibody collection one shot at a time.

[shiny!]

Re: Flu vaccine efficacy (CIDRAP study findings)

I plan to keep building my influenza antibody collection one shot at a time.

Try to avoid the shots that use mercury-containing Thimerosal as a preservative. The last time I got a flu shot they gave me the option of getting a mercury-free shot.

[wayiwalk]

Re: Flu vaccine efficacy (CIDRAP study findings)

I had viral pneumonia when I was a teen, and through my twenties, every 3rd year it seemed like I'd get a flu that turned into bronchitis.

Since turning 40, I get a flu shot every year. I always get a little sick, what could be best described as flu-like symptoms, I need to be careful I don't over exert myself for the 3 - 5 days after getting the shot, but it is a much better alternative to getting a full blown flu.

Completely effective in the sense I don't get a minor flu like reaction? No.

Completely effective in that I haven't had a full blown flu in almost 10 years? Yes.

All for the price of feeling under the weather one week of the year? I'll take it!

[jiimbergin]

Re: Flu vaccine efficacy (CIDRAP study findings)

I have been deathly sick 4 times, 1956,1969 and 2001, 2010. The first 3 I had flu shots and the last a pneumonia shot. I too take vitamin D3. I will never take another flu shot.

[llanlad2]

Re: Flu vaccine efficacy (CIDRAP study findings)

That kind of efficacy for vaccines is fairly typical. 50% of people vaccinated may avoid getting the flu. 25% of people may have reduced symptoms. No effect for 25%.
Even the highest realistic targets for vaccines is 70%.

I apologise for going off-topic but one thing I learned recently is not to trust pharmaceutical statistics. Within the report attached by Mastershake it mentions that studies are "supoptimal with poorly defined endpoints" Proper studies do not show "the level of protection attributed to the vaccines." The article below is a real eye-opener for those interested in how pharma companies twist research and that even supposedly objective academic research is anything but. Well worth reading.

Reboxetine is a drug I have prescribed. Other drugs had done nothing for my patient, so we wanted to try something new. I'd read the trial data before I wrote the prescription, and found only well-designed, fair tests, with overwhelmingly positive results. Reboxetine was better than a placebo, and as good as any other antidepressant in head-to-head comparisons. It's approved for use by the Medicines and Healthcare products Regulatory Agency (the MHRA), which governs all drugs in the UK. Millions of doses are prescribed every year, around the world. Reboxetine was clearly a safe and effective treatment. The patient and I discussed the evidence briefly, and agreed it was the right treatment to try next. I signed a prescription.

But we had both been misled. In October 2010, a group of researchers was finally able to bring together all the data that had ever been collected on reboxetine, both from trials that were published and from those that had never appeared in academic papers. When all this trial data was put together, it produced a shocking picture. Seven trials had been conducted comparing reboxetine against a placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal, for doctorsand researchers to read. But six more trials were conducted, in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials was published. I had no idea they existed.
It got worse. The trials comparing reboxetine against other drugs showed exactly the same picture: three small studies, 507 patients in total, showed that reboxetine was just as good as any other drug. They were all published. But 1,657 patients' worth of data was left unpublished, and this unpublished data showed that patients on reboxetine did worse than those on other drugs. If all this wasn't bad enough, there was also the side-effects data. The drug looked fine in the trials that appeared in the academic literature; but when we saw the unpublished studies, it turned out that patients were more likely to have side-effects, more likely to drop out of taking the drug and more likely to withdraw from the trial because of side-effects, if they were taking reboxetine rather than one of its competitors.
I did everything a doctor is supposed to do. I read all the papers, I critically appraised them, I understood them, I discussed them with the patient and we made a decision together, based on the evidence. In the published data, reboxetine was a safe and effective drug. In reality, it was no better than a sugar pill and, worse, it does more harm than good. As a doctor, I did something that, on the balance of all the evidence, harmed my patient, simply because unflattering data was left unpublished.
Nobody broke any law in that situation, reboxetine is still on the market and the system that allowed all this to happen is still in play, for all drugs, in all countries in the world. Negative data goes missing, for all treatments, in all areas of science. The regulators and professional bodies we would reasonably expect to stamp out such practices have failed us. These problems have been protected from public scrutiny because they're too complex to capture in a soundbite. This is why they've gone unfixed by politicians, at least to some extent; but it's also why it takes detail to explain. The people you should have been able to trust to fix these problems have failed you, and because you have to understand a problem properly in order to fix it, there are some things you need to know.
Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don't like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug's true effects. Regulators see most of the trial data, but only from early on in a drug's life, and even then they don't give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion.
In their 40 years of practice after leaving medical school, doctors hear about what works ad hoc, from sales reps, colleagues and journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are, too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it's not in anyone's financial interest to conduct any trials at all.
Now, on to the details.
In 2010, researchers from Harvard and Toronto found all the trials looking at five major classes of drug – antidepressants, ulcer drugs and so on – then measured two key features: were they positive, and were they funded by industry? They found more than 500 trials in total: 85% of the industry-funded studies were positive, but only 50% of the government-funded trials were. In 2007, researchers looked at every published trial that set out to explore the benefits of a statin. These cholesterol-lowering drugs reduce your risk of having a heart attack and are prescribed in very large quantities. This study found 192 trials in total, either comparing one statin against another, or comparing a statin against a different kind of treatment. They found that industry-funded trials were 20 times more likely to give results favouring the test drug.
These are frightening results, but they come from individual studies. So let's consider systematic reviews into this area. In 2003, two were published. They took all the studies ever published that looked at whether industry funding is associated with pro-industry results, and both found that industry-funded trials were, overall, about four times more likely to report positive results. A further review in 2007 looked at the new studies in the intervening four years: it found 20 more pieces of work, and all but two showed that industry-sponsored trials were more likely to report flattering results.
It turns out that this pattern persists even when you move away from published academic papers and look instead at trial reports from academic conferences. James Fries and Eswar Krishnan, at the Stanford University School of Medicine in California, studied all the research abstracts presented at the 2001 American College of Rheumatology meetings which reported any kind of trial and acknowledged industry sponsorship, in order to find out what proportion had results that favoured the sponsor's drug.
In general, the results section of an academic paper is extensive: the raw numbers are given for each outcome, and for each possible causal factor, but not just as raw figures. The "ranges" are given, subgroups are explored, statistical tests conducted, and each detail is described in table form, and in shorter narrative form in the text. This lengthy process is usually spread over several pages. In Fries and Krishnan (2004), this level of detail was unnecessary. The results section is a single, simple and – I like to imagine – fairly passive-aggressive sentence:
"The results from every randomised controlled trial (45 out of 45) favoured the drug of the sponsor."
How does this happen? How do industry-sponsored trials almost always manage to get a positive result? Sometimes trials are flawed by design. You can compare your new drug with something you know to be rubbish – an existing drug at an inadequate dose, perhaps, or a placebo sugar pill that does almost nothing. You can choose your patients very carefully, so they are more likely to get better on your treatment. You can peek at the results halfway through, and stop your trial early if they look good. But after all these methodological quirks comes one very simple insult to the integrity of the data. Sometimes, drug companies conduct lots of trials, and when they see that the results are unflattering, they simply fail to publish them.
Because researchers are free to bury any result they please, patients are exposed to harm on a staggering scale throughout the whole of medicine. Doctors can have no idea about the true effects of the treatments they give. Does this drug really work best, or have I simply been deprived of half the data? No one can tell. Is this expensive drug worth the money, or has the data simply been massaged? No one can tell. Will this drug kill patients? Is there any evidence that it's dangerous? No one can tell. This is a bizarre situation to arise in medicine, a discipline in which everything is supposed to be based on evidence.
And this data is withheld from everyone in medicine, from top to bottom. Nice, for example, is the National Institute for Health and Clinical Excellence, created by the British government to conduct careful, unbiased summaries of all the evidence on new treatments. It is unable either to identify or to access data on a drug's effectiveness that's been withheld by researchers or companies: Nice has no more legal right to that data than you or I do, even though it is making decisions about effectiveness, and cost-effectiveness, on behalf of the NHS, for millions of people.
In any sensible world, when researchers are conducting trials on a new tablet for a drug company, for example, we'd expect universal contracts, making it clear that all researchers are obliged to publish their results, and that industry sponsors – which have a huge interest in positive results – must have no control over the data. But, despite everything we know about industry-funded research being systematically biased, this does not happen. In fact, the opposite is true: it is entirely normal for researchers and academics conducting industry-funded trials to sign contracts subjecting them to gagging clauses that forbid them to publish, discuss or analyse data from their trials without the permission of the funder.
This is such a secretive and shameful situation that even trying to document it in public can be a fraught business. In 2006, a paper was published in the Journal of the American Medical Association (Jama), one of the biggest medical journals in the world, describing how common it was for researchers doing industry-funded trials to have these kinds of constraints placed on their right to publish the results. The study was conducted by the Nordic Cochrane Centre and it looked at all the trials given approval to go ahead in Copenhagen and Frederiksberg. (If you're wondering why these two cities were chosen, it was simply a matter of practicality: the researchers applied elsewhere without success, and were specifically refused access to data in the UK.) These trials were overwhelmingly sponsored by the pharmaceutical industry (98%) and the rules governing the management of the results tell a story that walks the now familiar line between frightening and absurd.
For 16 of the 44 trials, the sponsoring company got to see the data as it accumulated, and in a further 16 it had the right to stop the trial at any time, for any reason. This means that a company can see if a trial is going against it, and can interfere as it progresses, distorting the results. Even if the study was allowed to finish, the data could still be suppressed: there were constraints on publication rights in 40 of the 44 trials, and in half of them the contracts specifically stated that the sponsor either owned the data outright (what about the patients, you might say?), or needed to approve the final publication, or both. None of these restrictions was mentioned in any of the published papers.
When the paper describing this situation was published in Jama, Lif, the Danish pharmaceutical industry association, responded by announcing, in the Journal of the Danish Medical Association, that it was "both shaken and enraged about the criticism, that could not be recognised". It demanded an investigation of the scientists, though it failed to say by whom or of what. Lif then wrote to the Danish Committee on Scientific Dishonesty, accusing the Cochrane researchers of scientific misconduct. We can't see the letter, but the researchers say the allegations were extremely serious – they were accused of deliberately distorting the data – but vague, and without documents or evidence to back them up.
Nonetheless, the investigation went on for a year. Peter Gøtzsche, director of the Cochrane Centre, told the British Medical Journal that only Lif's third letter, 10 months into this process, made specific allegations that could be investigated by the committee. Two months after that, the charges were dismissed. The Cochrane researchers had done nothing wrong. But before they were cleared, Lif copied the letters alleging scientific dishonesty to the hospital where four of them worked, and to the management organisation running that hospital, and sent similar letters to the Danish medical association, the ministry of health, the ministry of science and so on. Gøtzsche and his colleagues felt "intimidated and harassed" by Lif's behaviour. Lif continued to insist that the researchers were guilty of misconduct even after the investigation was completed.
Paroxetine is a commonly used antidepressant, from the class of drugs known as selective serotonin reuptake inhibitors or SSRIs. It's also a good example of how companies have exploited our long-standing permissiveness about missing trials, and found loopholes in our inadequate regulations on trial disclosure.
To understand why, we first need to go through a quirk of the licensing process. Drugs do not simply come on to the market for use in all medical conditions: for any specific use of any drug, in any specific disease, you need a separate marketing authorisation. So a drug might be licensed to treat ovarian cancer, for example, but not breast cancer. That doesn't mean the drug doesn't work in breast cancer. There might well be some evidence that it's great for treating that disease, too, but maybe the company hasn't gone to the trouble and expense of getting a formal marketing authorisation for that specific use. Doctors can still go ahead and prescribe it for breast cancer, if they want, because the drug is available for prescription, it probably works, and there are boxes of it sitting in pharmacies waiting to go out. In this situation, the doctor will be prescribing the drug legally, but "off-label".
Now, it turns out that the use of a drug in children is treated as a separate marketing authorisation from its use in adults. This makes sense in many cases, because children can respond to drugs in very different ways and so research needs to be done in children separately. But getting a licence for a specific use is an arduous business, requiring lots of paperwork and some specific studies. Often, this will be so expensive that companies will not bother to get a licence specifically to market a drug for use in children, because that market is usually much smaller.
So it is not unusual for a drug to be licensed for use in adults but then prescribed for children. Regulators have recognised that this is a problem, so recently they have started to offer incentives for companies to conduct more research and formally seek these licences.
When GlaxoSmithKline applied for a marketing authorisation in children for paroxetine, an extraordinary situation came to light, triggering the longest investigation in the history of UK drugs regulation. Between 1994 and 2002, GSK conducted nine trials of paroxetine in children. The first two failed to show any benefit, but the company made no attempt to inform anyone of this by changing the "drug label" that is sent to all doctors and patients. In fact, after these trials were completed, an internal company management document stated: "It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine." In the year after this secret internal memo, 32,000 prescriptions were issued to children for paroxetine in the UK alone: so, while the company knew the drug didn't work in children, it was in no hurry to tell doctors that, despite knowing that large numbers of children were taking it. More trials were conducted over the coming years – nine in total – and none showed that the drug was effective at treating depression in children.
It gets much worse than that. These children weren't simply receiving a drug that the company knew to be ineffective for them; they were also being exposed to side-effects. This should be self-evident, since any effective treatment will have some side-effects, and doctors factor this in, alongside the benefits (which in this case were nonexistent). But nobody knew how bad these side-effects were, because the company didn't tell doctors, or patients, or even the regulator about the worrying safety data from its trials. This was because of a loophole: you have to tell the regulator only about side-effects reported in studies looking at the specific uses for which the drug has a marketing authorisation. Because the use of paroxetine in children was "off-label", GSK had no legal obligation to tell anyone about what it had found.
People had worried for a long time that paroxetine might increase the risk of suicide, though that is quite a difficult side-effect to detect in an antidepressant. In February 2003, GSK spontaneously sent the MHRA a package of information on the risk of suicide on paroxetine, containing some analyses done in 2002 from adverse-event data in trials the company had held, going back a decade. This analysis showed that there was no increased risk of suicide. But it was misleading: although it was unclear at the time, data from trials in children had been mixed in with data from trials in adults, which had vastly greater numbers of participants. As a result, any sign of increased suicide risk among children on paroxetine had been completely diluted away.
Later in 2003, GSK had a meeting with the MHRA to discuss another issue involving paroxetine. At the end of this meeting, the GSK representatives gave out a briefing document, explaining that the company was planning to apply later that year for a specific marketing authorisation to use paroxetine in children. They mentioned, while handing out the document, that the MHRA might wish to bear in mind a safety concern the company had noted: an increased risk of suicide among children with depression who received paroxetine, compared with those on dummy placebo pills.
This was vitally important side-effect data, being presented, after an astonishing delay, casually, through an entirely inappropriate and unofficial channel. Although the data was given to completely the wrong team, the MHRA staff present at this meeting had the wit to spot that this was an important new problem. A flurry of activity followed: analyses were done, and within one month a letter was sent to all doctors advising them not to prescribe paroxetine to patients under the age of 18.
How is it possible that our systems for getting data from companies are so poor, they can simply withhold vitally important information showing that a drug is not only ineffective, but actively dangerous? Because the regulations contain ridiculous loopholes, and it's dismal to see how GSK cheerfully exploited them: when the investigation was published in 2008, it concluded that what the company had done – withholding important data about safety and effectiveness that doctors and patients clearly needed to see – was plainly unethical, and put children around the world at risk; but our laws are so weak that GSK could not be charged with any crime.
After this episode, the MHRA and EU changed some of their regulations, though not adequately. They created an obligation for companies to hand over safety data for uses of a drug outside its marketing authorisation; but ridiculously, for example, trials conducted outside the EU were still exempt. Some of the trials GSK conducted were published in part, but that is obviously not enough: we already know that if we see only a biased sample of the data, we are misled. But we also need all the data for the more simple reason that we need lots of data: safety signals are often weak, subtle and difficult to detect. In the case of paroxetine, the dangers became apparent only when the adverse events from all of the trials were pooled and analysed together.
That leads us to the second obvious flaw in the current system: the results of these trials are given in secret to the regulator, which then sits and quietly makes a decision. This is the opposite of science, which is reliable only because everyone shows their working, explains how they know that something is effective or safe, shares their methods and results, and allows others to decide if they agree with the way in which the data was processed and analysed. Yet for the safety and efficacy of drugs, we allow it to happen behind closed doors, because drug companies have decided that they want to share their trial results discretely with the regulators. So the most important job in evidence-based medicine is carried out alone and in secret. And regulators are not infallible, as we shall see.
Rosiglitazone was first marketed in 1999. In that first year, Dr John Buse from the University of North Carolina discussed an increased risk of heart problems at a pair of academic meetings. The drug's manufacturer, GSK, made direct contact in an attempt to silence him, then moved on to his head of department. Buse felt pressured to sign various legal documents. To cut a long story short, after wading through documents for several months, in 2007 the US Senate committee on finance released a report describing the treatment of Buse as "intimidation".
But we are more concerned with the safety and efficacy data. In 2003 theUppsala drug monitoring group of the World Health Organisation contacted GSK about an unusually large number of spontaneous reports associating rosiglitazone with heart problems. GSK conducted two internal meta-analyses of its own data on this, in 2005 and 2006. These showed that the risk was real, but although both GSK and the FDA had these results, neither made any public statement about them, and they were not published until 2008.
During this delay, vast numbers of patients were exposed to the drug, but doctors and patients learned about this serious problem only in 2007, when cardiologist Professor Steve Nissen and colleagues published a landmark meta-analysis. This showed a 43% increase in the risk of heart problems in patients on rosiglitazone. Since people with diabetes are already at increased risk of heart problems, and the whole point of treating diabetes is to reduce this risk, that finding was big potatoes. Nissen's findings were confirmed in later work, and in 2010 the drug was either taken off the market or restricted, all around the world.
Now, my argument is not that this drug should have been banned sooner because, as perverse as it sounds, doctors do often need inferior drugs for use as a last resort. For example, a patient may develop idiosyncratic side-effects on the most effective pills and be unable to take them any longer. Once this has happened, it may be worth trying a less effective drug if it is at least better than nothing.
The concern is that these discussions happened with the data locked behind closed doors, visible only to regulators. In fact, Nissen's analysis could only be done at all because of a very unusual court judgment. In 2004, when GSK was caught out withholding data showing evidence of serious side-effects from paroxetine in children, their bad behaviour resulted in a US court case over allegations of fraud, the settlement of which, alongside a significant payout, required GSK to commit to posting clinical trial results on a public website.
Nissen used the rosiglitazone data, when it became available, and found worrying signs of harm, which they then published to doctors – something the regulators had never done, despite having the information years earlier. If this information had all been freely available from the start, regulators might have felt a little more anxious about their decisions but, crucially, doctors and patients could have disagreed with them and made informed choices. This is why we need wider access to all trial reports, for all medicines.
Missing data poisons the well for everybody. If proper trials are never done, if trials with negative results are withheld, then we simply cannot know the true effects of the treatments we use. Evidence in medicine is not an abstract academic preoccupation. When we are fed bad data, we make the wrong decisions, inflicting unnecessary pain and suffering, and death, on people just like us.

[mooncliff]

Re: Flu vaccine efficacy (CIDRAP study findings)

That is a very good point. There are many problems with the pharmaceutical industry because it is excessively profit motivated, or more exactly, instead of making legitimate profits to support the horrendous research costs, as in everything done by flawed humans, in the end they wind up juking the system and becoming extractive instead of producing the best goods and services they can. Will start another post about how ridiculous many drug trails are: If you get the result you want, you publish; if you dont get the result you want, the study never sees the light of day. Attempts to solve this problem by registering every trial that is started and demanding that every study be published? Take a guess at how well that is working...

[mooncliff]

Re: Flu vaccine efficacy (CIDRAP study findings)

Yes, the flu can be really bad, and often fatal to the elderly.
I have also read that, for example, the swine flu vaccine that I had all those years ago may still confer some resistance to a new strain of swine flu when it appears.

One thing about vaccines, though. I would avoid getting multiple vaccines at one time (I dont mean a combination vaccine, I mean not getting one in your left arm, another in your right arm, another in your right butt, another in your left. This is because your lymph system is more or less divided into the four limbs, so you can get a vaccine in each limb). Vaccines, even killed ones, can have serious side effects. My doctor once gave me four vaccines at once... hmm, maybe tetanus, hepatitis A, flu, and something else I cant remember, one in each arm and each buttock, and I asked him if that was OK to get that many at once, and he said yes. Well, that triggered arthritis in my knees that lasted 6 months! It fortunately went away completely after a couple of years, but it was really really bad... difficult to get up out of a chair to go to the bathroom. I jokingly told him I was going to sue him... but he knew I was joking and shrugged sheepishly... I certainly did not think he thought that was going to happen.

Hand washing seems to reduce the number if viruses on your hands, reducing risk of transmission.
http://www.public.health.wa.gov.au/c...RISK%20(2).pdf
Every year, I spend $20 bucks on really good Biore hand soap from Costco for the office. People think I am just being nice, and of course I am worried about the pregnant women in the office because an infection can cause serious problems even decades later, but from pure self-interest (since many people think if there is no obvious direct self-interest that I am strange), I essentially bet $20 bucks per year that I will reduce my risk of a cold or flu by half, and missing even a day of work will cost much more than $20.

My rules are:
If I think I have the flu or a very bad cold, because my job is fairly flexible, I do not go to work no matter what.
If the cold is not so bad, I wear a mask. This freaks out visitors to Japan to see people wearing masks, but they are just trying to avoid infecting other people, or they are suffering from hayfever and trying to block the pollen.
I wash my hands often.
I do not touch elevator buttons with my fingertips. I use a knuckle or an elbow. If there is a door handle, I try to grab it where other people will not. I hold on to the pipe on the subway rather than the strap (no one holds on to the pipe, as evidenced by the soot on my hand when I let go). Many viruses are spread by touching an object and then touching your mouth, nose, or eyes.

[Chris Coles]

Re: Flu vaccine efficacy (CIDRAP study findings)

I apologise for going off-topic but one thing I learned recently is not to trust pharmaceutical statistics. Within the report attached by Mastershake it mentions that studies are "supoptimal with poorly defined endpoints" Proper studies do not show "the level of protection attributed to the vaccines." The article below is a real eye-opener for those interested in how pharma companies twist research and that even supposedly objective academic research is anything but. Well worth reading.

Can you please provide a link to it.... thank you.

[nedtheguy]

Re: Flu vaccine efficacy (CIDRAP study findings)

redacted

[mooncliff]

Re: Flu vaccine efficacy (CIDRAP study findings)

Ha ha! You read my mind. That is exactly what I am going to post. He has a TED talk, etc., so was going to look up all the information for a new post.

[Master Shake]

Re: Flu vaccine efficacy (CIDRAP study findings)

Good point on hand hygiene. Unless you are within 6 feet of an infected person when they sneeze, airborne transmission is not a risk for colds and flu. People often forget the basics, something that's true even in hospitals among doctors and nurses.