Rosenberg writes: "The drug companies have outsourced all their operations from drug development and testing to clinical trials to scientific and academic writing so that they have become nothing but marketing organizations at their core."
David Healy works to raise awareness of how pharmaceutical companies have turned into marketing organizations. (photo: ShockMD.com)
Pharmageddon: The Drug Industry's Grip on Our Health and Lives
24 June 12
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An interview with David Healy, an expert witness in homicide, suicide and birth defect legal actions involving psychotropic drugs.
avid Healy is a Professor of Psychiatry at Bangor University. He is a former Secretary of the British Association for Psychopharmacology, and author of over 175 peer reviewed articles, 200 other pieces and 20 books, including The Antidepressant Era, and The Creation of Psychopharmacology from Harvard University Press,The Psychopharmacologists Volumes 1-3, Let Them Eat Prozac, Mania, & Pharmageddon. He has been involved as an expert witness in homicide, suicide and birth defect legal actions involving psychotropic drugs, and in bringing problems with these drugs to the attention of American and British regulators, as well raising awareness of how pharmaceutical companies sell drugs by marketing diseases and co-opting academic opinion-leaders, ghostwriting their articles.
Rosenberg: Your new book, Pharmageddon, gives a bleak picture of the doctored data, skewed drug trials and rigged treatment guidelines that characterize today's pharmaceutical industry. Many people will be shocked to learn the abuses are not limited to the US, where direct-to-consumer advertising is legal, but found in Europe.
Healy: The situation is identical. Pharma actually finds socialized health care systems easier to exploit. And despite direct-to-consumer advertising, more money is spent on marketing to doctors who are the real consumers. They are also pressured by the treatment guidelines process which is based on "evidence" that Pharma makes sure to keep secret so they are really in the dark, though they may not realize it.
Rosenberg: One example you give of Pharma's reach and power is the eerie symmetry between the Texas Medication Algorithm Project (TMAP), conceptualized and funded by US Pharma, and Britain's National Institute for Health and Clinical Excellence (NICE).
Healy: Despite their public/private differences, both organizations recommend the use of branded antipsychotics like Risperdal, Zyprexa and Seroquel before the use of older, affordable antipsychotics which of course enriches Pharma. One of the otherissues is this-there is a new bill aimed at speeding up the FDA approval process yet again-and also getting regulators to take into account the jobs that come with a strong pharmaceutical sector. Both America and Europe have been keen to keep their companies happy and have turned a blind eye to the outsourcing of clinical trials to Asia and Eastern Europe.
Rosenberg: In Pharmageddon, you chronicle how clinical trial oversight has gone from a hospital and university-based system to a for-profit system run by clinical research organizations or CROs.
Healy: The drug companies have outsourced all their operations from drug development and testing to clinical trials to scientific and academic writing so that they have become nothing but marketing organizations at their core. At each juncture where they have spun off a traditional responsibility, no one has objected and so it continues.
Rosenberg: There have been reports of risks to human subjects in overseas trials as well as bribes and protocol irregularities. Who oversees the ethics of outsourced trials and the quality of their data?
Healy: Clinical trials are overseen by private Institutional Review Boards, which are funded by the organizations they regulate-
Rosenberg: Like Moody's and Standard & Poor's are funded by their clients?
Healy: Yes. A recent large trial for the antipsychotic Abilify demonstrates the danger with outsourced clinical trials. On the basis of about 28 trials in the US, Abilify did not prophylactically stabilize mood as the manufacturer wants to claim. But when data from just two trials from Mexico were mixed in, it did.
Rosenberg: Most of Pharma's power to mislead and harm comes from such opaque and distorted data, you charge in Pharmageddon.
Healy: Without access to the raw drug data, medical professionals cannot practice responsible medicine and guidelines cannot be written. Yet Pharma, with very few exceptions, refuses to publish the data and share them with practitioners. This result is guidelines that are fictions and doctors who lack critical information they need to prescribe and treat.
Rosenberg: Pharma's stonewalling of data and use of ghostwriters has resulted in articles in major medical journals that made Vioxx, hormone therapy and Neurontin look safe when they weren't. Another example you give is a paper in the Journal of the American Association of Child and Adolescent Psychiatry in which GlaxoSmithKline (GSK) has made the antidepressant Paxil look safe by hiding raw data. Then editor, Mina Dulcan, says about the missing data, which hid Paxil's suicidal side effect in children, "I can't control the authors. No, I don't have regrets."
Healy: If we were getting our drug information from the New York Times instead of medical journals, we would all be a lot safer. When theTimes reporter Jayson Blair was found to have fabricated stories, he was history. But the editors and writers involved with journal fraud still have their jobs and the articles are not even retracted. In fact, Liz Wager, the chair of the Committee on Publication Ethics (COPE) is herself Pharma linked.
[Ed note. The COPE site says, "Liz provides writing, editing, training and consultancy services for various pharmaceutical companies (most recently Astra Zeneca, Cephalon, Cordis, GlaxoSmithKline, Eli Lilly, Janssen-Cilag, Merck Serono, Mundipharma, Norgine, Novo Nordisk, Sanofi Pasteur and Vifor). ]
Rosenberg: Many conflicts of interest in your book, including COPE's leadership, are structural and create a closed loop of misinformation, especially because of the money that Pharma wields. How can sunlight and transparency ever break through?
Healy: Some colleagues and I are in the process of fine-tuning a free web site that offers FDA MedWatch data with other crucial dug information but gets people affected by treatment to report in detail for perhaps the first time. The site, called RxISK.org, also helps patients file an adverse event report to US and Canadian authorities, with other countries to follow. For too long, patients, doctors and pharmacists have been isolated from each other when they encounter adverse drug events and only Pharma's messages get out. This will help them communicate directly.
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Just in time for the campaign season, I think our President has just discovered his cojones!!!!
Hold onto your woohoos, Risa - the title of this article is purposefully misleading. O didn't "reject" the pipeline -- he simply postponed the issuance of the permit until after February 21. Like all our corporate owned politicians, O doesn't give a damn about your letters and petitions.
Nay sayers do nothing and expect everything...ti me is coming when you will need a vest and there will be none left. We are leaving those who are against, those who careless, those who do nothing where they belong....in the Past
Better yet, it's an election year. He was told that it would be politically beneficial to "push back" on this pipeline til after the election. Believe me, it will be pushed back through and approved this time next year after he win.
Why does anyone here still trust Obama? He only does things like this ( ie things that seem progressive and "good" ) when his panel of experts tell him and his financial supporters ( the lobbyist ) that the political gain will be worth the temporary set back in collecting profits from ( insert anti-progressiv e agenda) and that they will make more after as a result.
Side note:
Obama doesn't care about us, and he's certainly not a liberal. Is he better than Newt Gingrich if it comes down to it? I ask this in theory, regarding the idea of a second term version of Obama. I would imagine no. They would be equal. Who knows though. I do know, however, that he won't have to be re-elected and can focus on his corporatist agenda single handedly just like Bush did in his second term. They have to at least pretend during the their first term.
NEVER VOTE REPUBLICAN !!
our future depends on it
WE need leadership and governance which protects "The People," the environments, and the commons, and regulates corporate interests so that there WILL be a livable future.
Money and profits are NOT wealth OR security.
Healthy community and healthy environments ARE real wealth and security folks.
Please define "the lower class" and perhaps your source for insight on what that group of people may be thinking.
It I$ up to us to take the whirled back, and remove a lot of spin and bullshit, until we get a world back.
As far as I can tell, we have 2 choices before us, continue with business as usual and rush quickly into oblivion, or change and demand/create a livable future.
Join me in being a N.O.O.P.
NOT ON OUR PLANET! No more war, nukes, gmos, or corporate bullshit.
It IS up to us, and we have NOTHING to lose, and a livable future to gain.
We are allowing the inmates and loony nutjobs to run things, while really, we ARE the power. N.O.O.P! No more.
But with momentum and that is what we must keep up, the pipeline could be stopped permanently. This Country and he knows it, does not have the money or resources to undo the mess, the havoc, the poisons that come with it.
Also WOrld Environmental council is fining Canada for its emissions and these tar pits are keeping Canada in its hole. Time Canada is made to clean up. I do not care if they ship it to whomever wants it, but we do not get any of it. Profits will not benefit the USA in anyway, I do not see the rich corporations paying their fair share yet...show that to the noecons and their inbreds.
I believe if we are to keep this out, we must continue to show why, and we must show Ms O and the kids why. She is an important person, cares about children and families. I do not believe she would want to see children poisoned, do you?
Never vote Republican
They said it is not feasible to transport to Vancouver but it is okay for us to transport it 5 times further. Love ya Canada but this is your Mess, clean it up once and for all.
If this was such a good money maker, Canada could have built the refineries needed decades ago and been done...nope, they figured someone would jump in...well, time they do the jumping.
The US already has almost 800,000 km of oil pipelines. Much of it old. I'm astonished that all your water has not been ruined already since such a tiny increase in the kilometers of new pipeline is such a threat while vastly longer old pipelines are out there.
Gee what will use the roads... Tourists by chance? I guess you have not read that many companies who left the USA are not making a profit. It costs too much between boats, trains, trucks, so many are rethinking coming back to .....
By the way, many of us are buying American, guess what, that means that if we continue to do so we will continue to see the American Companies grow. Mexicoe, South America, Canada all need to ship to us and each other, I said ship by truck is actually correct. Then of course we do have building materials from unfortunaltely the Koch Bros, Georgia Pacific that comes east so we can remodel, build. So what will cross those bridges, trucks for food, clothes, building materials, and safer on better roads. Hopefully people going to Jobs DUH
Pretty short-sighted and suggestive of a true stick-in-the-mu d. Give us some forward looking ideas or go back to sleep.
But then again what they're doing to Alberta is insanity.
BUT the railroads are heavily regulated, regularly inspected, reasonably efficient and accountable (I've looked at the rail inspector's certification requirements), and use less fuel per mile traveled than any other means of transport (I just wish that the country would see the sense and go to mass rail transit) unlike any hastily constructed and open to corruption and shortcutting pipeline, with it's additional land-rape, very much like the Nuclear industry -which we also HAVE to get Obama away from!
Pretty negative sort o' dude, ain't ya!
It doesnot bother me the transporstation by rail, for sheer availability of our rails, and I trust it there than on a road in front of me, having a tractor trailer jack knife and spill. But train wrecks happen are just as unsafe for communities, water and wildlife. Canada made this mess and could have kept up with it, chose not to so as not to dip into profit margin. Wow does that sound like Cement Plants, Bethlehem Steel etc? Why yes and this mode of stupidity continues today..Profits before Safety...blame the worker/Union not the Corporation
Canada vetoed this because of safe environment but Canada is on a rock in a hard place because their emission and environmental score card is costing them for decades.
We do not realize just how much contaminated, hazardous, nuclear waste is being transported daily in any situation because GW took placards off if you all go back. Many of us fought against it but GW did what he was told. Ask Sierra Club and other Environmental Org. Many sleeping for many years...time to wake up.
NEVER EVER vote GOP/TP but do VOTE 2012.
The planet finally gets a break -and O'b doesn't fold.
Gimmerings of light at last. I hope this a sign of a tougher more resolute leader who can see which way at least one of the winds is blowin'.
And does anyone have any idea why Canada can't refine their own oil? Do they ship all their oil out for refining then re-import it?
The pacific pipeline is due to go to Kitimat which is ice free. There is a lot of available land and it's on Canada largest West Coast Fjord with lots of room for big ships to anchor in a sheltered location.
Did you know the USA already has almost 800,000 km of oil pipelines more than any other nation.
Now they are fined and in red in environmental points in World Council. So they decided to put a vote up to transport this material to Vancouver. Experts showed that it would not be adviable as the tar sand would not go thru modern pipes (we have since put this in front of OB thru Engineers, EPA etc.) This is very heavy, concentrated stuff that doesnot exactly flow. So Costs to have pumping done for 1300 plus miles would be costly. Issues of pipe failure, spills etc Cost was not in any win situation, would cost more, insurance thru roof, failure/clean up They could not afford it. There are transcripts. Most Canadians were glad but now Alberta is living with greed leftovers...contamination.
So someone talked to someone who talked to someone and the GOP told th4e Plains states to go and dig up the prairie, move plant species, and creatures because the pipes were coming. We started this in the West before anyone knew there was a plan. Then the Stated decided there would be NO Public Forum because this is the USA and we do not take Public Input seriously.
Tar is tar, this is beyond crude...few refine.
Which world council is this? Is the USA a member? How do they collect these fines?
If I had actual time I could give you many facts, councils and world organizations however, you seem to have more time than I so look them up for yourself.
No one is bashing Canada, if you read half my answers to people, my friends live there. But your tar sands pits could have been dealt with from day one.
if you also notice I do hammer some corporations of america there are just too many and not enough time to bore all.
So grow up, get on web and start a research. We would love to help you. You all can organize, you did already...but your mess in Alberta is yours to clean up, that is Responsibility for Actions. Your Corporations made lots of money and spent it ... they should have been prepared to clean up, they knew what was going to happen. Many of you did also, and you allowed it to happen. Same here and around the world. Now I have a meeting to go to on Fracking Adios I actually do things, tonight I have classes in disaster incident system of planning. I am older, with handicaps, yet I am able to read, research and work at making this planet better, and getting Problems fined if not shut down.
Am glad he is saying no for right now.
Got to do homework.
I saw engineers on TV decade ago say not way, then within two years our own say this is a no go, pipes cannot take it.
Personally if Texas wants it, fine let them have it but they can go pick it up by boat pay the costs, permits etc, Environmental Fees but I do not know who will allow it going out thru their port.
Again it is not oil or crude, you all have misconception. If it was oil, Canada would be refining. It is the lowest sluggish crap, it is too thick for pipes. Get some background, then perhaps your answers will be in front of you.
From the US State Dept.'s draft environmental impact statement:
"Construction of the proposed Project, including the pipeline and pump stations, would result in hiring approximately 5,000 to 6,000 workers over the 3 year construction period. As indicated above, it is expected that roughly 10 to 15 percent of the construction workforce would be hired from local labor markets, thus 500 to 900 local workers throughout the entire region of influence would be hired."
Of course Boehner and his GOP colleagues are not the least concerned about the greenhouse gas emissions from Canadian oil sands crude oil which will be more than 80% greater than oil refined in the U.S. Moreover, this translates into three times more global warming pollution than conventional oil.
Another perfect example of how the GOP puts profits above all else, regardless the damage and destruction to the environment and the planet.
GOP have no brains, no less conscience.
Most Canadians would prefer to refine the oil and keep the jobs here but we are told refineries are multi-billion dollar projects and the US has the free capacity.
I assume that those who object to the minute fraction of world CO2 production due to the oil sands will be closing down all your coal fired power plants that produce vastly more CO2?
Most of us would love an alternative to coal fired power plants here in the U.S. We'd love to shut those down, too. Anything to reduce global warming..... because the stakes are extremely high for life on planet earth.
And for anybody who isn't up on this pipeline, it's an export pipeline only, i.e., all of it is expected to go to Europe and Latin America. In other words, this pipeline will do nothing to reduce dependence on foreign oil! In fact, it will actually INCREASE gas prices for Americans!
1. You do understand that most of the CO2 due to oil comes when you burn it not when you refine it.
2. Less than 1/1000 is in my book a minute fraction.
3. Why the big fear of climate change. Not that long ago much of Europe and North America was covered by a thick ice sheet. A return to that worries me far more than the prospect of the earth returning to the incredibly rich biological state it was in when palm trees grew along Canada's arctic coast and much of our coal and oil was being created.
http://www.scientificamerican.com/article.cfm?id=seven-answers-to-climate-contrarian-nonsense&page=6
I believe you are in Jr HS, please take some extra classes, you do need it.
Republican mentality is everywhere!
Spouse said if you look at our own needs at power companies, solution/tar is that thick the lines will have to heated up. Will have to have access points to run check pigs to check thickness of pipe walls and do clean out. Some point these pipes will be above ground where this happens.
Got to work in the field and we are not engineers. My spouse is in Contracting Field/Union. I am an Environmental Activist. Both of us are taking classes on disaster management which is available to all online thru FEMA.
Lots of studies have been done, no one wanted to listen decades ago, now everyone wants everyone else to clean up after them.
there is something we are not being told as a fish tale. If this is profitable after all the mechanics, pipes, equipment needed...I want stock. Jobs will be couple years, then done, just like other pipeline. Nice while it lasts.
Most of the jobs will be to Public Officials Relatives, Friends, couple nice nice to military to make Mrs OB happy but this is a joke. I have seen it before. Later I will get some info but most of us know where to look
Do some research yourself. I may have to clean up puppies, help change baby and senior diapers but you can do your own work.
We know all about our Corporations and if you would actually be able to read you would see we are fighting the Congress on many issues right now.
I personally have gotten more people fined for dumping, fires, emissions than you ever will because you are probably a snitch for some company. Your Tar Sands are not Minute or else you would have cleaned them up...in fact if there is not problem...why don't you get some shovels and clean up Alberta. Low emissions, there is no room anymore for any emissions.
We the People have beaten more things than you could count I am giving you consideration you can count. Do not be too sure this will be allowed .... Canada has to take control of their mess and clean it up as they should have when they started. Wouldnot be having problem if they would have invested time and money to refine there and then.
They've effectively put off a final decision by punting it down the road until after the election in 2013. One can only hope they'll kill it then, but that's not a given by any stretch. If Obama fails to win reelection, it's going to get an immediate green light.
Republicans are screaming about the loss of jobs. Clean renewable energy and energy conservation are cheaper than new, unconventional fossil fuels. Moreover, dollar for dollar they produce far more jobs!
Time to build a fight, time to get good information, time to keep things quiet so as not to hear their engineers tell us how safe it is to drink without taking the first plunge at drinking.
Thinking about the pumping stations should be one subject many of you and friends could research. How large they would have to be, and now they hyave to come thru Canada...there environmental people said no once...now if we contacted them and got a think tank of the pipes, the couplings needed, sizes, pumping stations...Nois e, emissions...the y are a problem in areas for sewage and water, costly to run...Alberta to Texas there is something goin on here, as I do not see money in these tar oil, moving it thru pipes... At what force, what is that going to move at, this is not crude, this is something that can be investigated. There is something fishy in this scenario and you are all missing it.
What are you alluding to: "something fishy in this scenario?"
He just said he wouldn't sign it until a month from now. Then he'll probably sign it.
Don't celebrate the battle until you've won the war. There's a long, long way to go.
It can be stopped, and I have enough info on all the blogs for you all to get some brain power together to perhaps call for a referendum esp out west. Where are all these big time Environmental states who love tourism and love the big sky, fishing, colorado river etc?
This was political - sadly like every single piece of slightly liberal legislature he signs or for which he pretends to stand. I wish it wasn't true, but unfortunately it's reality. He is merely putting off allowing the pipeline until after the election. That simple.
I voted for Obama but sadly he is "Bush Part Two". Obama was just a P.R. change for the corporatocracy. The only difference if you really dig deep is that Obama fights for and sometimes passes liberal gestures once in a while to keep his base just content enough. This is the the same way Bush would push to ban gay marriage or some other right wing gesture, and sometimes let it pass. In the end, they don't care about these things. They just want to keep their bases happy, so they carry on their real business - making things work for their corporate sponsors, oops, i mean donors.
Get involved nice to critique OB but look in mirror..you can do something and make a difference
Did you not see Obama go to Boehner's and MConnell's district to point out bridges that needed to be reinforced??
He went to Eric Cantor's distrct too.
BUT THE REPUGS ONLY WANT TO OBSTRUCT
I am 53, going to classes, fighting for rights, marching, petitioning, researching
If everyone here got a group together and did some homework on what this entails and there is data, since there has been engineers giving testimony that this will not work, time we get it together and stop it.
Get a referedum on ballot. Get Canadian Organization that fought it to help but don't sit there and blame others...this Country is ours, so let';s start showing the Government who they work for!
I have fought so many things and even temporary good news, is relief, let's us breathe so we can start anew.
This is not going away, the Nits who want Mitt will rerun this and no matter what he or public want, if Mitt gets in, this travesty will continue. It is already in the works so this Permit shutdown is a good thing. States have already destroyed wilderness/plai ns and creatures without any permission or permits. Let's watch them try to make that up, cause no one will pay them until it goes thru...perhaps they will learn a lesson, hopefully people will keep up the pressure.
Canada the tar in in your Pit, you deal with this big time money maker, you transfer it to the Pacific Ocean for all that money and all those pretend jobs. You made the mess, now it is time it is cleaned up. WHO, Environmental Council wants this cleaned up, time you clean up your backyard. I love ya, but this is your mess not ours.
Thanks Obama, You must continue to remember that we must leave the Children a Future, not more of our Past.
I think I am going to jump up and down, then get back to cleaning up fracking once and for all.
The land that has been mined has to be reclaimed and replanted. (Millions of trees already.) That is the law. Did you know that.
Since they have been producing this oil for years and shipping much of it to the USA by pipeline could it be that the only fishy thing here is your grasp of the facts. I suggest you do your homework.
I am hoping we work with Canadians and stop this. We must show Canadians how to get the Shills who did this, clean it up.
We have Palmerton Superfund Site, they formed an Action Group who is working to make Palmerton better today. It is a lot of washover but the Community has Grants, and investments in them. Where repsonsible people came together, we got action. Even from Republicans but todays slumlords do not care about what happens to us, they do not see the future only now.
My friends live in Canada, they love their Country and fight for it. Now they have to unite and make those who made money and left them this mess, clean it up. There was a way to have done this better, but greed was all they saw.
Why should we hurt American Prairies, Deserts, Farms, Water, Indian Reservations, Families, Wildlife so more Corporations make more money on a Project that is not Safe. We know it is not safe. Federal Engineers of the Government, not ours, Testified.
I'm sure there was a back room conversation with Obama and some Oil and Bank execs that went something like this:
OBAMA:: "Let me clear. This is just temporary. As soon as I get re-elected, we will re-present the pipeline bill and I will green light it. This is just a temporary bump".
BIG OIL/ BANKER: (winks at obama). "Sounds Good Mr. President".
( Banker writes another campaign bribe, oops, i mean donation ).