Tamiflu: Millions wasted on flu drug, claims major report
bbc.com
bbc.com
http://www.cochrane.org/cochrane-reviews/top
Note that these are abstracts of the full reviews (which they charge for access).
On a side note, meta-research deserves more funding!
http://blog.givewell.org/2013/06/06/meta-research-update/
edit: I linked to the wrong review before (not the one under discussion), so I edited that out. As gwern mentions in another comment, the link is broken in the BBC article. nairteashop found a different news release which seems to be the right link:
http://www.cochrane.org/features/tamiflu-relenza-how-effecti...
http://money.cnn.com/2005/10/31/news/newsmakers/fortune_rums...
...amongst other prominent Project for a New American Century warmongers.
- politicians control the media (more or less true).
- media create the panic
- people panic and ask for drugs
- politicians buy the drugs and take massive kick backs in the process (certainly not unheard of), working with a single pharma company
- people later discover it was all a scam
You can argue it was exploited but not that it never existed.
So the phenomenon around H1N1 and the commercial implications for the companies involved is very close to what we refer as a scam. The risk of global killer Pandemic was grossly exaggerated for the benefit of a few.
Citation needed...
The reason it was picked up by the WHO was based on statistical facts and evidence. It may have been promoted by news agencies and drug companies, but that was again based on statistics and what was researched in the early cases. If it was all total FUD and made sooo much money why aren't they doing this every year?
http://www.nybooks.com/articles/archives/2011/dec/22/world-b...
I say all this to suggest that it's not a waste of taxpayer money by uninformed politicians... no - the politicians are very well informed.
Take a look at Aspartame controversies. In essence the US Attorney charged with opening a grand jury into their research withdrew and took a job working for Searle, manufacturers of Aspartame. The Grand Jury never occurred. A few years later the FDA Commissioner who gave Aspartame the green light went on to work for their PR company. To this day people don't trust Aspartame even though (debatably) the research shows it's safe.
So even perceived conflicts of interest can adversely affect public perspectives on the objectivity of scientific research. That's not good in a democracy.
http://en.wikipedia.org/wiki/Aspartame#Safety_and_approval_c...
Aside from liver-damage-suicide-through-overdose, and accidental overdose, there are a common conditions where you'd want headache relief (hangover, dehydration, ...) where the liver-damage risk for a normal dose is substantial (and people commonly take 2-3x the normal dose if they have "a bad headache, as more is obviously better...).
Another huge sin of the US drug war is mixing likely-to-be-abused painkillers like codeine with acetaminophen to lower their "abuse potential" -- but, with junkies not being rational, it leads to abusers destroying their livers.
> Aspirin is usually a better option at low doses (as long as your stomach does not suffer too much from it, since it causes stomach bleeding).
This is excellent advice, but the scaremongering re Reye's is unnecessary. Many more lives & livers would be saved by people ceasing their use of acetaminophen than would be risked by people switching to aspirin.
(In fact, Reye's syndrome was used as an example of something with a "vanishing" baseline risk in a study in Epidemiology recently.)
But they may have kids.
Look, most of us don't need to be told that coffee is hot, and can burn you, but we're told anyway.
> Epidemiological studies have demonstrated an association between aspirin taken for viral illnesses and the development of Reye’s syndrome.[8] But no animal model of Reye’s syndrome has been developed in which aspirin causes the condition.[9]
It's tiring to repeat it, but correlation and causation are two very different things.
My point wasn't to say Aspirin is or isn't better than Tylenol.
My point is to say taking medical advice on internet forums, isn't a good idea.
Actually, in most cases, it seems many developed countries outside of the US think so, see my other post: https://news.ycombinator.com/item?id=7564311
It may not be a good idea but if it exists, it means there's a lack of information out there.
While this is a much lower risk for 20 year olds and up, which may in fact make Aspirin safer than acetaminophen it is not the case for pediatrics.
Considering this site has a not insignificant number of under-19s and many who have kids it is important not to spread misinformation and as always consult with a physician or pharmacist.
[1] http://www.aafp.org/afp/2009/1215/p1472.html [2] http://www.cdc.gov/ncidod/diseases/reye.htm [3] http://www.mayoclinic.org/diseases-conditions/reyes-syndrome...
That's only the position in the US, I believe. In France, as long as you are more than 30 kg (children from 9 to 15) you can take aspirin.
> http://www.doctissimo.fr/medicament-ASPIRINE-UPSA.htm
I seriously doubt North American kids are facing lethal dangers while kids in France would be safe at the same age, it's not like the populations are very genetically different or something.
EDIT: Confirmed in Japan as well, you can give aspirin to children and even babies in Japan - there are no particular contraindications except prior patient history, and the discretion of the HCP. Link : http://www.info.pmda.go.jp/go/pack/3399007H1021_1_15/@Generi...
So, because FDA decides something does not mean everyone agrees with it universally.
My experience in obtaining information via the Internet goes back over a quarter century, and I've got to disagree with your advice in both the specific (medical) and general case.
I'm not saying "believe everything you hear", but take the information under advisement and evaluate claims.
Among the first stories I came across via the Net were the Fleischman-Pons cold fusion story (1989), 25 years ago this year, and the Intel "FOOF" bug (1997) [1,2], both of which largely predated the widespread adoption of the World Wide Web.
The first story turned out to be unsubstantiated research, and highly critical responses appeared almost immediately. The FOOF bug turned up with proof-of-concept tests, and eventually even a Linux kernel boot-time check (which I fondly remember scrolling past many, many times). In both cases, dissemination of information online eventually arrived at the truth.
And that's pretty much the case for all information. Hoaxes, including scientific and medical hoaxes existed before the Internet and WWW, and continue after. Shortly after the the cold fusion story, I was receiving, via postal mail, information on a laetrile cancer treatment (utterly unsubstantiated) as a result of someone who'd suggested same to me, in person, and passed on the information. Much as a useful therapy would have benefited someone I love and miss to this day, the hoax information was anything but helpful. The hepotoxicity of acetominiphen / paracetemol (Tylenol) is something I also first learned of by direct personal contact, in this case from someone who'd worked on drug safety trials with the compound, and absolutely positively refused to touch the stuff or allow anyone in his family to do so. That turned out to be pretty well substantiated.
One of the benefits of information conveyed through open forums is that others can challenge and correct the information provided, and cite references and resources. No, it's not perfect, but it's pretty good.
________________________________
Notes:
1. http://partners.nytimes.com/library/national/science/050399s...
http://www.thisamericanlife.org/radio-archives/episode/505/u...
The same is true of dextromethorphan (DXM), the main active ingredient in cough syrup.
For many naive teenagers, cough syrup is their introduction to recreational drug use because it's available OTC. Unfortunately, most teenagers are also impulsive and can't be bothered to do much research beforehand. Threads like this one below, titled "6,276 mg acetaminophen...am I gonna die?", are unfortunately very common.
https://www.lef.org/protocols/appendix/otc_toxicity_01.htm
This might be paracetamol is preferred over ibuprofen et al in combination analgesics like Vicodin; if they just wanted to kill junkies they could do better.
Hydrocodone is schedule II, unless mixed with APAP at which point it drops to S III. I'm not sure there's any way to view that except as anti-human. And ironically enough, restrictions on pharmaceutical grade opiates makes the prices so high people end up using impure heroin instead. It's unlikely this is an unknown effect to regulators.
Agree that acetaminophen/tylenol/paracetamol is the safest OTC and non-OTC analgesic within the 'safe' dose limit <4000mg/24h (pills are typically 325/500/650mg)
Liver failure from tylenol toxicity that is not a suicide attempt is actually quite rare. People that intentionally overdose and die usually take large amounts, like 10-20gm AND don't come to the hospital until very late or when they are found by someone else. Smaller doses and arriving in hospital within a day can usually be treated quite successfully with N-acetylcysteine/NAC.
Tylenol + Alcohol = Lowers the dose needed for liver injury.
Alcohol causes orders of magnitude more damage to livers and to our society than tylenol does. More than half the liver transplants here are at least partially related to alcohol, and the rest are mostly hepatitis C, fatty liver, cancer, autoimmune, etc. People on the transplant list do tend to drink "a lot", such as 5-10 bottles of beer/day for 10-20 years
Tylenol is combined with opiates (eg. Tylenol#3, Percocet, Vicodin) because both work in the central nervous system (as opposed to NSAIDs that work peripherally), resulting in a synergistic effect.
Aspirin and other NSAIDs (ibuprofen/Advil, naproxen/Aleeve) are ok when used occasionally, but long-term chronic use has side effects as mentioned (eg. bleeding, kidney injury, can precipitate heart attacks in people with coronary disease, etc.)
http://www.bencollier.info/content/suffering-existential-ang...
I haven't seen a societal study to say it's better or worse as a group of individuals. I would be really interested in that.
"Questions about the accuracy of these claims and the efficacy of both preparations prompted an international team of researchers, led by Dr Tom Jefferson, a Cochrane Review author and independent epidemiologist based in Rome, Italy, to examine newly available evidence and amalgamate two previously published Cochrane Reviews focusing on the efficacy of these interventions into one comprehensive, updated review, published in the January 2012 issue of The Cochrane Library.
In carrying out this research, the Cochrane team was reluctant to focus their efforts on published trial reports available in scientific journals, because while many trials have been conducted around the world, only a few have been published.
“We identified that a large number of studies, including data from 60% of the people who have been involved in randomised, placebo-controlled phase III treatment trials of oseltamivir, have never been published. This includes the biggest treatment trial ever undertaken on oseltamivir that on its own included just over 1,400 people of all ages,” noted Jefferson. "We are concerned that these data remain unavailable for scrutiny by the scientific community."
Following a public pledge by the manufacturer of oseltamivir, Roche, to make full study reports available to scientific investigators, the Cochrane team decided to focus instead on manufacturers’ clinical study reports (typically submitted to regulators) and regulators’ comments. They called reports and comments “regulatory information”. Availability of documents generated by national and regional regulatory bodies during licensing processes in the UK, USA, continental Europe and Japan, along with partial trial reports from the manufacturer of oseltamivir, Roche, and from the European regulator European Medicines Agency (EMA), enabled the researchers to verify information from the trials.
When the team compared published data with the more complete unpublished trial records, they found apparent inaccuracies in the published record of the trials. For example, while unpublished trial reports mentioned serious adverse events (some even classified as possibly related to oseltamivir), one of the two most cited publications makes no mention of such effects, and the other states “... there were no drug-related serious adverse events”.
Having pieced together information from more than 16,000 pages of clinical trial data and documents used in the process of licensing oseltamivir, the Cochrane team raises critical questions about how well the drug works, as well as about its reported safety profile. While the drug did reduce the time to first alleviation of symptoms by an average of 21 hours, it did not reduce the number of people who went on to need hospital treatment. Results from the reanalysis of data also raise questions about how the drug works as an influenza virus inhibitor."
http://www.cochrane.org/features/tamiflu-relenza-how-effecti...
Not saying anything about Tamiflu's effectiveness, just that 2-3 days can be a lot.
This report is pretty damning, regardless.
Similarly, 3 years ago, both of my sons and my wife tested positive, all saw improvements within 24 hours of taking it. I took a prophylactic dose that time and did not get the flu.
Anecdotal, I guess, but I would take it again in similar circumstances.
Is this a common thing?
Possibly relevant: Australian.
http://www.cdc.gov/flu/professionals/diagnosis/clinician_gui...
[1] http://www.sciencebasedmedicine.org/new-evidence-same-conclu...
According to meta-analyses on the topic assessing doses of 200mg vitamin C or more, vitamin C has failed to reduce the frequency of colds in the normal population but was successful in reducing the duration of colds (on average 8-14%);[149][145] when looking at studies investigating extreme physical stress (marathoners and skiiers), the risk of getting a cold was halved (which has been noted in past meta-analyses[144])
Definitely not a marathoner/skiier but I work out about an hour a day and I never expect Vitamin-C to prevent colds. I only take it after 2 to 3 day of sensing an incoming cold.
Pharmaceutical companies don't use marketing budgets to drive demand among the general population?
However, I disagree that they use normal marketing strategies with governments. They play politics instead. In this case they had the backing of the World Health Organization, and media outlets screaming words like pandemics every ten seconds. We all know that dead bodies don't look good on a politicians resume willing to run for reelection.
I agree that those materials were not glossy brochures and adverts with smiling mother and happy children, but those information packs are very definitely marketing and not just a dump of all the data they have.
That's partly why Cochrane had to struggle for so long to get the full data.
If H1N1 or derivatives caused a serious pandemic I would much rather have some Tamiflu than not, even if it's effectiveness varied for patient to patient.
It's easy to say money was wasted with hindsight.
They're not saying that the money is wasted because we haven't had a flu outbreak. They are saying that, if there was one, Tamiflu would be as useful as paracetamol. It would be like (in your analogy) someone claiming that the snow clearing equipment bought was known to be faulty or not work in cold conditions. In that case, saying the money was wasted would be justifiable.
I don't have an answer, other than the observation that there are too many cases these days where public health and commerce don't work well together.
At the time Tamiflu was believed to work well, and must have had studies that backed this up (otherwise it wouldn't have got past NICE).
If it is in fact no better than paracetamol then with hindsight you could argue it was a mistake to stockpile, however I was reassured that my government had prepared, which in itself could have avoided some additional panic and bad press.
I think this is not the same exact drug as Tamiflu, but the parallels - mass vaccination etc - are worth drawing.
The scary thing about Pandemrix is that some people - mostly children and young adults - immediately got narcolepsy http://en.wikipedia.org/wiki/Narcolepsy
Now the various investigations have all said they can find no link between narcolepsy and Pandemrix, and yet they don't really explain the suddenness of it all. Seems a hell of a coincidence.
Narcolepsy is not some silly little "sleep disorder". This was really brought home to me - literally - by knowing someone who's child got it hours after their Pandemrix jab =(
The micro-problem here is the Swedish state trying to avoid paying for care (its untreatable, as I understand it) and all that wrangling about taking responsibility. I think most parents of suffers are really out to share around the burden of responsibility, rather than caring so much about the costs of care.
The macro-problem is convincing people that the next time we are told to go get a jab, we should :(
Here's Penn & Teller talking about Vaccines: https://www.youtube.com/watch?v=RfdZTZQvuCo
Science isn't going to win over my wife as easily as all that. And I am very divided myself, however rational I try and be.