Peer Review – Not Worth The Paper

Amazing:

The present investigation was an attempt to study the peer-review process directly, in the natural setting of actual journal referee evaluations of submitted manuscripts. As test materials we selected 12 already published research articles by investigators from prestigious and highly productive American psychology departments, one article from each of 12 highly regarded and widely read American psychology journals with high rejection rates (80%) and nonblind refereeing practices.

With fictitious names and institutions substituted for the original ones (e.g., Tri-Valley Center for Human Potential), the altered manuscripts were formally resubmitted to the journals that had originally refereed and published them 18 to 32 months earlier. Of the sample of 38 editors and reviewers, only three (8%) detected the resubmissions. This result allowed nine of the 12 articles to continue through the review process to receive an actual evaluation: eight of the nine were rejected. Sixteen of the 18 referees (89%) recommended against publication and the editors concurred. The grounds for rejection were in many cases described as “serious methodological flaws.” A number of possible interpretations of these data are reviewed and evaluated.

(via WUWT)

Atopic Dermatitis ("Neurodermitis") Caused By Dairy and Eggs?

Another chronic skin condition which is possibly caused by (pasteurized) milk and dairy: Atopic Dermatitis ("Neurodermitis").

The German weekly "Der Spiegel" had this to report in August 2011 (translation mine):

… After Nina Meier's odyssey through doctors offices and many treatments, the turn came with a few words: "Abstain from cow's milk and eggs," advised a general practitioner. "I said to myself, shit, I'll simply try it," says Meier. "It can't get any worse." For one week the symptoms got worse - but then came the turning point. "I could rub off my skin like scabs, underneath new skin came to light. After the old skin had gradually peeled off, it was fine."

Since then she has never been in treatment for their eczema again. With regards to dermatologists she is now skeptical. Nina Meier says she had trusted doctors too much and "ignored nutrition during the search for the cause, because the doctors said nutrition did not play a role". Meanwhile, she can tolerate even a little bit of cow's milk or egg. "And even if my body reacts, I won't get no stressed anymore. Because I now know the cause." …

http://www.spiegel.de/panorama/gesellschaft/jahrelange-fehltherapie-gefangen-in-der-eigenen-haut-a-780722.html

The entire article in "Der Spiegel" is a truly horror story of her various treatments by "evidence based" medical industry – at least it has an happy end for her. What about the countless others who are stuck in this ordeal?

So after Acne, Aphthous Ulcers, Behçet's and Psoriasis, I can add this to my growing list. Why is it the skin, that is the "target"? What is the common mechanism here? I'm sure it will be fascinating to read the mechanism, once medical science will find it out in a couple of decades… I sure hope I live that long.

90% Of Preclinical Cancer Research Is Not Reproducable

Oh my:

In their Comment article 'Raise standards for preclinical cancer research', C. Glenn Begley and Lee Ellis (Nature 483, 531–533; 2012) refer to scientists at Amgen who were able to reproduce findings in only 11% of 53 published papers. Several correspondents have asked for details of these studies, which were not provided in the article.

The Amgen scientists approached the papers' original authors to discuss findings and sometimes borrowed materials to repeat the experiments. In some cases, those authors required them to sign an agreement that they would not disclose their findings about specific papers. Begley and Ellis were therefore not free to identify the irreproducible papers — a fact that the Comment should have mentioned.

Nature, like most journals, requires authors of research papers to make their data available on request. In this less formal Comment, we chose not to enforce this requirement so that Begley and Ellis could abide by the legal agreements.

The scientists at Amgen could not have implemented their study had they reserved the right to reveal the outcome for individual papers. The Comment highlights important systemic problems in preclinical cancer research, which we felt appropriate to communicate to our readers, even though the authors could not disclose the studies in question.

"Safety And Efficency"

For all those who think that the FDA will help solve ME/CFS, that the pharmaceutical industry will help solve ME/CFS, that "we, the patients" should lobby the FDA and doctors to help the pharmaceutical industry:
You are deluded.



BBC Panorama - "Paxil Study 329"


(Via 1 Boring Old Man)

Translational Medicine Has Failed

1 Boring Old Man (emphasis mine):

One reason that I suggest you read the whole article is that in his thinking, the perspectives of the pharmaceutical industry, psychiatry, and the NIMH are discussed as if they are the same thing. For example, he discusses academic research and pharmaceutical research as if they are in synergy with different strengths and weaknesses, an unbroken chain:
…
Here’s the thing about that argument – I can’t think of any examples. The drugs that have characterized the post-DSM-III era are all me-too drugs developed by pharma. What the academics have done is sign on to the industry’s papers as KOLs, involve themselves as sites for drug trials, and traveled around on speaker’s bureaus. If the academics are doing what he described, I missed it. Dr. Hyman, Fibiger, and Insel should be in a better position than I am to know about such things – but I think that this scheme, at least over the last quarter century, is more their shared delusion fantasy than some hard reality.

So while it seems a cynical thing to say, I can’t think of any accomplishments by the Translational Medicine era to mention other than to produce a lot of articles and a few new journals. So how could it be stalled? It never took flight in the first place except as a monotonous rhetorical device and a name for a bunch of centers that haven’t produced very much. The Translational Medicine rallying cry "from bench to bedside" has lacked in productivity from the bench side of the equation.

It seems "Translational Medicine" is nothing but a fancy buzzword to get funds for research, and to hide the fact by how much medical science has been stalled in the last couple of decades…

Marvellous

David Healy:

Companies don’t engage in conspiracies, we are being told, they are masters of the cock-up, and if given a choice of feet to shoot themselves in will opt for both feet.

Truly marvellous.

If Pharma made cars…

David Healy:

If Pharma made cars..

Companies are legally obliged to answer the question “Can cars kill?” with a “Yes”. They can usually evade this by answering instead the question “Will this car kill me?” or “Did it kill him?” with a “No – absolutely not – if things went wrong it was the Dr’s fault”. But ultimately they depend on their professors (who are carefully managed independent contractors under no legal obligation) to deliver the message “Cars Cannot Kill”.

If Philip Morris made drugs..

If Philip Morris made medicines, all available drugs would come with prominent Black Box warnings that this product can kill consistent with the traditional medical view that Every Drug is a Poison, and the Art of Medicine lies in finding the right dose.

There would be a ban on all advertising including Direct to Consumer Adverts. The use of drugs for children would be severely restricted, and exceptional rather than common.

As company products are available over-the-counter rather than on prescription-only, doctors would be openly skeptical of the claimed benefits and would fully support ongoing research to demonstrate the risks. Somewhat more puritanically perhaps some doctors might be expected to attempt to get Philip Morris sponsorship of university activities banned.
…

Bioinformatics

Someone whose blog I read linked to the following rant:

A farewell to bioinformatics

I’m leaving bioinformatics to go work at a software company with more technically ept people and for a lot more money. This seems like an opportune time to set forth my accumulated wisdom and thoughts on bioinformatics.

My attitude towards the subject after all my work in it can probably be best summarized thus: “Fuck you, bioinformatics. Eat shit and die.”

Bioinformatics is an attempt to make molecular biology relevant to reality. All the molecular biologists, devoid of skills beyond those of a laboratory technician, cried out for the mathematicians and programmers to magically extract science from their mountain of shitty results.

And so the programmers descended and built giant databases where huge numbers of shitty results could be searched quickly. They wrote algorithms to organize shitty results into trees and make pretty graphs of them, and the molecular biologists carefully avoided telling the programmers the actual quality of the results. When it became obvious to everyone involved that a class of results was worthless, such as microarray data, there was a rush of handwaving about “not really quantitative, but we can draw qualitative conclusions” followed by a hasty switch to a new technique that had not yet been proved worthless.
…

I know next to nothing about bioinformatics. I know nothing about the author. But it resonates with me because of what I have seen with researchers trying to "extract science" from cytokine studies in ME/CFS.

Yes, it is plausible that cytokines are involved in ME/CFS. But considering that we know next to nothing about the possibly many disease that constitute ME/CFS, and considering that any disease is probably not a simple "this or that cytokine is too high or too low" case, I will keep on saying: Cytokine studies should be attempted, but we any "results" need to be rechecked in another cohort, and the results may turn out to be underwhelming or worthless.

Fuck That.

David Healy - Time to abandon evidence based medicine?

• You can't trust trial data
• You can't trust reviews (not even Cochrane Reviews)
• Real significant problems (e.g. increased suicides on Prozac) can be "statistically not significant"
• Data is hidden
• Evidence vs. Evident: Large controlled trials are needed to weed out the drugs that don't work – drugs that "really" work show their effects in small trials. If you need 10,000 people to show an effect, something is fishy.
• If alcohol were a novel substance, a (hypothetical) trial could be made that would show that alcohol works as an anti-depressant drug
• In this (hypothetical) "alcohol as anti-depressant drug" example, one could even get alcohol as drug to be included in the NICE-guidelines
• One (hypothetical) 6 week (!) trial alone (!) could "prove" that the economy would save lots of money by putting people on alcohol for depression
• And this (hypothetical) one 6 week trial would be enough "prove" that doctors would insist that patients should take this drug for life(!), because the condition is life-long
• If a drug causes symptoms (e.g. more suicides), which the disease can also produce, then a control trial can not answer that question for you
• Clinical trials are not the answer:
  1. If both the illness & the drug cause a problem
  2. If the clinical population is heterogenous (if the underlying condition is unknown)
  3. If the researchers don't know what they are doing
  4. Clinical trials cannot provide patient level answers
  5. Clinical trials do not reveal cause and effect
• Doctors will defend prescription drugs – and hereby delay investigation into adverse effects by 15 or more years

And all that is not even including the carnage done by quacks…

Fuck that.

We have all these amazing medical, technological and scientific advances, which should put us in a position to fight diseases in a way that would make all the Pasteurs and all the Enders' and all the Salks and all the Sabins of past times green with envy. Where is the evolution in medicine? Why does it seem to me that we are stuck in a dead end?

The medical profession does well with clearly defined illness – say HIV/AIDS – that, if left untreated, lead to clearly measurable, visible adverse outcomes. But things like depression? MS? T2DM? In all likelihood, the treatment may lead to worse outcomes than if the illness is left untreated.

And this hits me at the moment. My doctor is willing to try out medication for my ME/CFS and therefore I'm currently looking into what agonist drugs are available to stimulate the alfa 2A receptor which is shown to be involved in at least subgroup of patients. Besides

• the almost total lack of scientific interest in ME/CFS by the medical commuity that leads to a situation where every person with ME/CFS is going from one "personal drug trial" to the next because guiding trial data is non-existent,
• besides not having any certainty whatsoever what actually the pathology is in my case (besides some personal indication that the alfa 2A receptor might be involved for me as well),
• besides not knowing if a stimulation with an Ad2A agonist is actually the right thing to do, if it is the Ad2A in my case,
• and besides not knowing what the actual (vs. claimed) spectrum of adverse reactions of these drugs is,

besides that I am totally at loss whether the supposed alfa 2a agonists actually do what the pharmaceutical industry claims they do.

Should I give Guanfacine a try? Or rather Tizanidine? Maybe Xylazine? What about Lofexidine?  Is Brimonidine only for occular hypertension?

I know, let's play guinea pig! And if one doesn't work, or makes me awful, then we try the next! Oh boy, what fun.

I feel like I might go to a pharmacists, and at gun point take any random medication and try that – and not be worse off…

But it sure is nice to see a psychologist like David Healy sharing his good insight into the problems of his profession and giving his best to address them properly.

(Health) Research Expenditures

Labrigger on (health) research expenditures.

Cervantes on the Medical-Pharmaceutical-Industry

Cervantes on the Medical-Pharmaceutical-Industry:

The Senate finance committee has found that [the Medtronic corporation] paid -- get this, it's not a typo or an extra zero -- hundreds of millions of dollars to doctors to pretend to be the authors of articles they drafted, edited and approved praising its product InFuse. Senator Max Baucus says, "Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has." Indeed. The editors of Spine Journal weigh in: "If surgeons had known that the lead authors of the 13 original studies on InFuse had received payments ranging from $1.7 million to $64 million [sic!] from Medtronic and that its marketing employees were co-authors and co-editors, would they have been as eager to use InFuse on their patients?"

That's all well and good but BMJ fails to name the names of those "physicians." They are all cruising along with high powered appointments and continuing to publish.

Look AHEAD trial stopped

Look AHEAD trial stopped
Eat less, move more, have your heart attack on time!

With apologies for lack of any attention to the blog recently (which may be set to continue for some time) but this snippet just had to get passed on. This link from Karl:

http://www.theheart.org/article/1458351.do

More info here

http://www.nih.gov/news/health/oct2012/niddk-19.htm

And the glowing anticipation of success here from the planning stage:

https://www.lookaheadtrial.org/public/home.cfm

Pubmed gives a series of genuine success stories from the early days on all sorts of parameters. But the cardiovascular end points show how utterly useless these interventions are long term.

However the massive omission, from the quick look I've managed, is of any intention to report the all cause mortality. It seems very likely to me that more people died in the intervention group than in the usual care group, but p was > 0.05.

Call me a cynic, but I think they stopped the trial because they could see where that p number was heading. Has anyone seen a body count from anywhere in the trial?

Also, what might the outcome have been if the intervention group had been repeatedly bullied, harassed and indoctrinated to maintain a normoglycaemic, low grade ketogenic diet for 13.5 years? Say to an HbA1c of around 5%?

Ha ha ha bloody ha.

Peter

[Update]: And Seth Roberts on the topic.

“Actually, it’s worse than you know…”

The life of frauds and whistleblowers in the medical sciences:

…
I travelled to Telford last month to hear Wilmshurst give a lecture to the Royal Statistical Society on libel and other barriers to exposing research misconduct. It took me back to 1996 when we invited him to come to the BMJ and give a talk—behind closed doors—to our staff and advisers and colleagues from the Lancet. He reeled off case after case of misconduct, many of them involving prominent people. The audience listed intently, but I was unsure of the reaction. Might somebody leap up and say “How dare you accuse x of misconduct. He is one of the great men of British medicine”? In fact in my memory the reaction was the opposite. People said things like “Actually, it’s worse than you know…”
…
Now 16 years later Wilmshurst has a longer and updated list, and somebody in the audience asked if he thought things are getting better or worse. He thinks probably worse: he’s had seven whistleblowers contact him in the last two months.
…

Lot's and lot's and lot's of anecdotes and case studies, but when will there be more research as to causes and mechanisms, and when will there be real consequences to prevent this in the future?

Perhaps strangely it was his first story that best captured the corruption that Wilmshurst has been fighting all his professional life. It was the early 80s at St Thomas’ Hospital in London, and Wilmshurst was doing research into amrinone, a new drug for heart failure manufactured by Sterling Winthrop, a company since taken over. The drug was supposed to increase myocardial contractility, but Wilmshurst found that it didn’t. Worse, it had serious side effects. Wilmshurst and his boss prepared to publish, but Sterling Winthrop, the manufacturers of the drug, threatened legal action. The company also asked if Wilmshurst and his boss would be willing to meet with their experts. They agreed. The message was that St Thomas’ was getting very different results from everybody else and that their lab would be discredited if they were to publish.

And by the way, the next person who ignores the countless lifes of patients that have been endangered by medical fraud and says "Well, but science is self correcting" will be diagnosed with a mental disorder, pumped full of fraudulently tested pharmaceuticals and put into a lunatic asylum for the rest of his life.

One of the things that seems to make Wilmshurst so cheerful is the black humour of his stories. Many of them involve doctors who are guilty of misdemeanours but who sit in judgement on others. He told the story of Peter Richards who decided to bury the fact that Clive Handler, a doctor, at Northwick Park Hospital, was found guilty of using NHS research funds to subsidise his private practice at a time when Richards was medical director of the hospital and chair of the professional conduct committee of the GMC. Previously he had been dean of St Mary’s Medical School, prorector for medical education at Imperial College, and chair of the Council of Deans of UK Medical School and Faculties. When Handler eventually appeared before the GMC, the GMC’s lawyers ask that Richards stand down from chairing the committee. As Wilmshurst said, it’s as if a judge at the Old Bailey were to say “I’ll have to excuse myself from hearing this case as I helped the accused bury the body.” After having to stand down from this committee Richards continued to chair other conduct committees. Wilmshurst told several stories of doctors who had been found guilty of research misconduct but gone on to be deans and others in charge of researchers.

Like we have independent investigation, prosecution and courts for criminal cases, we need a similar criminal law with similar independent institutions for medical fraud.

"Mental health care: designed for evil"

Mental health care: designed for evil

The following is a storified version of events that led up to the way mental health care is organised in the UK today. It should be familiar to all mental health professionals, and shows, I hope, just how evil - and I do not use the word lightly - care provision truly has become.

Institutional care brings to mind horrific scenes. Whether it's the iatrogenic madness of Crispina at the end of The Magdalene Sisters, gossip about the Rosenhan experiment, Broadmoor, or a fondness for Foucault, mental health institutions bring to most people's minds padded walls, straitjackets, isolation, forced injections and unheard screams.

The truth, in some institutions, was certainly not very different from this, and many were the rich families who felt it too cruel to let relatives rot there as if imprisoned. Their alternative though, was the provision of private nurses working in the home, and as this was expensive it was the privilege of a select few. Institutions were expensive, too, for the state - more so even than prisons. And so the dream of mental health care outside internment grew as the number of institutions grew, in some circles because of love, in others because of profit.

Enter Roy Griffiths. Griffiths made his bones in Monsanto (director, 1964-68) and then Sainsbury’s (1968-91), and naturally, this gave him uniquely brilliant insight into mental healthcare. Thatcher had commissioned Griffiths in 1983 to write a diagnosis of the problems of the NHS. What he decided the NHS really needed was more managerialism and internal markets (ask anybody that works in the NHS today what the biggest problem and waste of money is, and they'll all tell you, too many managers and markets), and this seemed to set him up as the best possible person to respond to the media crisis brewing around the terrible quality of institutional care in the UK.

…

Haven't read it all yet, but it might be an interesting and different view on affairs.

I have read it now and it is a interesting and more general view on affairs and the general use of CBT on the general public in the UK, including two interesting links about CBT.

Reported average costs for clinical trials per drug: $22.4 million

And estimated median, net, corporate cost to develop a new drug: $56 million.

Our own estimate of pharmaceutical R&D is often misquoted as an average of $43 million per new drug, which commentators reject as being absurd. However, we make clear this estimate for the year 2000 does not include the cost of discovery (because it varies greatly and no one has accurate figures), nor the "cost of capital" (for reasons explained in our article which can be read here). Our estimate is the net cost to major companies after taxpayers cover about 50% of their R&D expenses. We use the median cost because the average cost gets inflated by a few costly R&D projects.
In sum, we estimate that the median, net, corporate cost to develop a new drug, based on the confidential cost data that companies reported to their policy research center at Tufts University, is $56 million in 2011, plus the unknown company costs of discovery and the artificial estimate of profits foregone, if you think it should be added. We also show that R&D costs for in-house new active ingredients are much higher, and costs for me-too variations are much lower than this single figure.
Our estimate is almost double the only solid corporate report of R&D costs, which can be found in audited tax returns from the late 1990s. Here companies reported average costs for clinical trials per drug of only $22.4 million. Not $224 million but $22.4 million
...
if the Forbes figures and business arguments are correct, then nearly all of the global pharmaceutical companies listed in their article would have gone bankrupt between 1997 and 2011.

So much for the claims that "a new drug costs over a billion dollars".

(via denialism)

A psychiatrist that is a pharma shill?

Just one link, there is more where this came from…

A prominent Emory University psychiatrist failed to tell the school about $500,000 he received from drug maker GlaxoSmithKline PLC while heading a government-funded research project studying Glaxo drugs, Sen. Charles Grassley alleged.

The payments to Charles Nemeroff, chairman of the Atlanta university's psychiatry department, compensated him for making presentations to doctors about Glaxo drugs, including its big-selling antidepressant Paxil, according to records Sen. Grassley obtained from Emory and Glaxo. The senator made the allegations in a letter to Emory President James W. Wagner dated Thursday.

In correspondence with Emory officials who police conflict-of-interest issues, Dr. Nemeroff repeatedly denied having a significant financial relationship with Glaxo, according to the records cited by Sen. Grassley, an Iowa Republican who has been investigating ties between academic researchers and the medical industry.

…

Statins: "Funding from the test drug company was associated with results (OR=20) and conclusions (OR=35) that favor the test drug."

In this 20 minutes lecture by Beatrice Golomb, she mentions (among others) a interesting study:


So funding from the industry can skew research results? Who would have though that!?

Study weaknesses included:

• Inadequate blinding
• Lack of concealment of allocation
• Poor follow-up
• Lack of intention-to-treat analyses

It is always the same: Blinding, blinding, blinding and proper controls – at least they got the last one right. A study that was not properly blinded may be helpful to explore association ("Could it be?") or safety at a phase I stage, but to draw definite conclusions one needs properly blinded and controlled studies.

Here's the abstract:

Factors Associated with Findings of Published Trials of Drug–Drug Comparisons: Why Some Statins Appear More Efficacious than Others
Lisa Bero, Fieke Oostvogel, Peter Bacchetti, and Kirby Lee

Abstract


Background
Published pharmaceutical industry–sponsored trials are more likely than non-industry-sponsored trials to report results and conclusions that favor drug over placebo. Little is known about potential biases in drug–drug comparisons. This study examined associations between research funding source, study design characteristics aimed at reducing bias, and other factors that potentially influence results and conclusions in randomized controlled trials (RCTs) of statin–drug comparisons.

Methods and Findings
This is a cross-sectional study of 192 published RCTs comparing a statin drug to another statin drug or non-statin drug.

Data on concealment of allocation, selection bias, blinding, sample size, disclosed funding source, financial ties of authors, results for primary outcomes, and author conclusions were extracted by two coders (weighted kappa 0.80 to 0.97). Univariate and multivariate logistic regression identified associations between independent variables and favorable results and conclusions. Of the RCTs, 50% (95/192) were funded by industry, and 37% (70/192) did not disclose any funding source.

Looking at the totality of available evidence, we found that almost all studies (98%, 189/192) used only surrogate outcome measures. Moreover, study design weaknesses common to published statin–drug comparisons included inadequate blinding, lack of concealment of allocation, poor follow-up, and lack of intention-to-treat analyses.

In multivariate analysis of the full sample, trials with adequate blinding were less likely to report results favoring the test drug, and sample size was associated with favorable conclusions when controlling for other factors.

In multivariate analysis of industry-funded RCTs, funding from the test drug company was associated with results (odds ratio = 20.16 [95% confidence interval 4.37–92.98], p < 0.001) and conclusions (odds ratio = 34.55 [95% confidence interval 7.09–168.4], p < 0.001) that favor the test drug when controlling for other factors. Studies with adequate blinding were less likely to report statistically significant results favoring the test drug.


Conclusions
RCTs of head-to-head comparisons of statins with other drugs are more likely to report results and conclusions favoring the sponsor's product compared to the comparator drug. This bias in drug–drug comparison trials should be considered when making decisions regarding drug choice.

Resveratrolgate: Dipak Who? Never heard of him.

Retraction Watch: So how peripheral was Dipak Das’ resveratrol work, really?

So when we uncovered a link showing that Das and Sinclair served together on the scientific committee of the “first international scientific conference of Resveratrol and Health” in Denmark in 2010, we figured we’d ask Sinclair whether he had misspoken. He responded:

I apologize. I did not expect my off-the-cuff comments to be printed. I will be more careful.

We appreciate Sinclair’s candor, although we feel obligated to note that he is hardly media-naive, having been quoted in countless articles about resveratrol over the years. He co-founded Sirtris, later sold to GlaxoSmithKline for $720 million, based on his early work on resveratrol

720 WHAT? For selling people resveratrol? Oh my, oh my, and these hypocrites complained that Atkins made money selling his book.

But yes, compared with hundreds (!) of millions, that guy Dipak Das was small fish.

(via)

Evidence based medicine vs. observational data

Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials

Abstract
Objectives To determine whether parachutes are effective in preventing major trauma related to gravitational challenge.

Design Systematic review of randomised controlled trials.

Data sources: Medline, Web of Science, Embase, and the Cochrane Library databases; appropriate internet sites and citation lists.

Study selection: Studies showing the effects of using a parachute during free fall.

Main outcome measure Death or major trauma, defined as an injury severity score > 15.

Results We were unable to identify any randomised controlled trials of parachute intervention.

Conclusions As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomised controlled trials. Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data. We think that everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute.

… The relevance to parachute use is that individuals jumping from aircraft without the help of a parachute are likely to have a high prevalence of pre-existing psychiatric morbidity. Individuals who use parachutes are likely to have less psychiatric morbidity and may also differ in key demographic factors, such as income and cigarette use. It follows, therefore, that the apparent protective effect of parachutes may be merely an example of the “healthy cohort” effect.

(via)

23 new drug applications in the US in 2008

Consider two numbers: 800,000 and 21.

The first is the number of medical research papers that were published in 2008. The second is the number of new drugs that were approved by the Food and Drug Administration last year.
…
And before anyone jumps to pin the blame on the F.D.A., it’s important to note that it’s not just new drug approvals that have declined — new drug applications have, too. Last year the F.D.A. received just 23.

Here are the conditions treated for those 23 drugs:

•  Diabetes Mellitus Type II (about 25 million people in the US)
•  Breast Cancer (1.35 million people in the US)
•  Rheumatoid Arthritis, Juvenile Idiopathic Arthritis (about 1 million people in the US)
•  Prostate Cancer (965,000 people in the US)
•  Schizophrenia (430,000 people in the US)
•  Allergic Conjunctivitis (425,000 people in the US)
•  Osteoporosis (416,000 people in the US)
•  Gout (385,000 people in the US)
•  Multiple Sclerosis (384,000 people in the US)
•  Cervical Dystonia, Blepharospasm, Glabellar Lines (about 30,000 people in the US)
•  Dupuytren’s Contracture (21,100 people in the US have this)
•  Gaucher Disease (10,600 people in the US)
•  Reduction of Excess Abdominal Fat in HIV-Infected Patients with Lipodystrophy (5000 people in the US)
•  NAGS Deficiency Hyperammonemia (320 patients per year diagnosed)
•  Pompe disease (90 patients in the US have this)

•  Contraception
•  Prevention of Thromboembolism in Atrial Fibrillation
•  Varicose Vein
•  Pneumonia, Skin and Structure Infection
•  Postcoital Contraception