Giant Pharma Company Claims Releasing Data On Drug Safety Is Illegal As It's Confidential And 'Commercially Sensitive'

from the nothing-to-fear? dept

Mon, Mar 18th 2013 8:51am — Glyn Moody

One of the initiatives gaining momentum around the world is open data -- the idea that, for example, non-personal data affecting the public should be made freely available. That's partly to improve transparency, so that citizens are more informed about what is happening, and partly to stimulate new kinds of business that build products and services based on that data.

An important category of open data that boosts transparency concerns basic drug safety information. Last month, Techdirt wrote about the AllTrials initiative that seeks to have key information about clinical trials placed in the public domain. As part of a wider move towards greater openness, the European Medicines Agency, the main body that licenses drugs in Europe, is starting to make available information that has hitherto been withheld.

Although doctors and patients are rejoicing at this greater transparency, not everyone is pleased by the move. AbbVie, the pharma company spun out of the Abbott Laboratories at the beginning of this year, for example, is taking legal action to stop it:

AbbVie, a pharmaceutical company has sought an injunction to block Europe's medicines regulator from releasing "confidential" and "commercially-sensitive" information on its blockbuster rheumatoid arthritis drug, a spokeswoman for the U.S. drugmaker confirmed on Sunday.

The Chicago-based company had taken legal action against the European Medicines Agency to stop it from releasing data on the effects in individual patients in clinical trials for its drug Humira, the Financial Times reported earlier on Sunday.

Except, of course, this isn't "confidential" and "commercially-sensitive" information: it's just basic data about its safety and efficacy. Doctors and patients surely have a right to know this before using products that could potentially have serious, even fatal, side-effects.

Another EU body, the European Food Safety Authority (EFSA), is also opening up:

The project is part of EFSA's continuing commitment to openness and addresses recommendations made by an independent evaluation report of the Authority's performance to further enhance transparency in its decision-making processes. EFSA's Science Strategy also highlights the importance of the Authority playing a leading role in making relevant scientific data more accessible to all interested parties.

Here's one particular set of data that it has now released: Given the level of public interest, EFSA will make all data on genetically modified (GM) maize NK603 publicly available on its website today (14 January).
Once more, that seems reasonable, since the public ought to be able to find about what is going into the food chain whose end-products it will consume. But some disagree: according to a story on Bakeryandsnacks.com, Monsanto is threatening to sue the EFSA over the release of this data.

What makes this a little confusing is that the company is quoted in that article as saying that it "firmly supports transparency" -- and yet here it is fighting tooth and nail against precisely that. Apparently, Monsanto also wants the regulatory environment in Europe to be "science-based". Modern science requires experimental data to be made available so that anyone can check the validity of the conclusions that have been drawn from it. If it can't be scrutinized, the conclusions can't be confirmed, and it's not science. So, given its call for "science-based" regulation, why does the company want to keep that data hidden? A cynic might almost suspect that Monsanto and AbbVie have something to hide.

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Filed Under: data, drug safety, information, pharmaceuticals, safety
Companies: abbott labs, abbvie

55 Comments

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Ninja (profile), 18 Mar 2013 @ 7:25am

A cynic might almost suspect that Monsanto and AbbVie have something to hide.

Anybody might almost suspect that Monsanto and AbbVie have something to hide.

FTFY
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Josh in CharlotteNC (profile), 18 Mar 2013 @ 7:32am

Re:
Everbody might almost suspect that Monsanto and AbbVie have something to hide.

FTFY
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artp (profile), 18 Mar 2013 @ 9:08am

They shouldn't have to release their data
The FDA shouldn't have to approve their drugs, either.

Tit for tat.

Former corporate FDA Validation Manager for computing
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artp (profile), 18 Mar 2013 @ 9:13am

Re: They shouldn't have to release their data
Self-reply - Sorry!

There are whistleblowers everywhere.

Bradley Manning is paying a huge price for letting citizens know what their government is doing in military areas.

Others have released data from banking, legislative actions, international trade agreements, even material about the **AAs.

So when is somebody going to pony up and release data from the FDA?
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Michael, 18 Mar 2013 @ 9:16am

Transparency
Apparently the new definition of transparency is:

Everyone else sharing information with us.

They must have gotten this from the US government.
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Anonymous Coward, 18 Mar 2013 @ 9:17am

Companies practice the politicians art, saying what the public wish to hear to gain popularity. However they misuse words so for instance transparency means we will tell you what we want you to know.
Obviously drug safety data can be commercially sensitive, as it might cause sales of the drug to end.
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jjmsan (profile), 18 Mar 2013 @ 9:22am

Re: Transparency
So I just have to accept that the medication the doctor proscribes for my condition will not cause me side effects. How about whether or not a resturant has passed a health inspection? It is commercially sensitive. Or is it only large companies with lots of lawyers who do not have to share their information?
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artp (profile), 18 Mar 2013 @ 9:35am

Release of GM trial data
AFAIK, this would be the FIRST release of ANY data on GM trials ANYWHERE in the world.

That is why Monsanto is so concerned about it. They definitely have something to hide there. They have patented their GM products as being new and nonobvious. They have gotten FDA approval based on the assertion that their GM products are substantially equivalent to existing products.

Of course they have something to hide. They have been able to keep one side of the equation secret until now. And those of us who have pointed out the apparent contradiction have been called kooks because we can't show the data.

Expect a huge fight on this matter.
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Wally (profile), 18 Mar 2013 @ 9:39am

What is really scary about these claims is that it puts human lives in very great danger. The transparency the AbbVie is fighting against prevents doctors from making sure that some of the medications a patient is using can safely be used with others. This transparency allows doctors to make sure that certain medications do not interfere with the functionality of other medications.

From My Wife:
"Not all prescriptions for birth control are used in contraception. They can be used in lower doses to treat PMDD and cases where a menstrual flow is abnormally high due to abnormally high hormonal levels of estrogen. You loose so much blood in these cases that you become dizzy and anemic during your monthly cycle to the point of fainting and blacking out. Without treatment, your period can last up to two or three weeks if you have either condition."

Thanks Hun :-)

The point is that not having transparency in the chemical reactions of different prescription drugs is dangerous and life threatening.

As an example, the effectiveness of a birth control pill can be negated with the use of Prozac, Celexa, and Zoloft. If there was no transparency, and you suffered from Seasonal Affective Disorder, or other forms of depression that would constitute the use of Prozac, Celexa, or Zoloft, you would run the risk of literally bleeding to death if you are a female in her monthly cycle while prescribed for said antidepressants.
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Anonymous Coward, 18 Mar 2013 @ 9:45am

Re:
Indeed.

"Transparency" to companies and governments, is a new buzzword they like to throw around because people seem to like to hear the word. They don't in fact know what it means at all, and the rare few that do usually use the term in the very loosest of senses: "throwing you a bone in the form of useless information, so hopefully someone thinks they are being honest" or possibly "getting access to everyone else's information."

Give it a few years and "transparency" will hold as much meaning as "cyber".
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Anonymous Coward, 18 Mar 2013 @ 9:48am

List of key phrase, and what they actually mean
"We're doing this because we fear a cyber-attack could cause World War Three!" - "I'm doing this because I like a fearful populace."

"We're doing this for the children." - "We want to erode your right in a palatable way."

"We want to be more transparent" - "Send the Delta teams to erase the hard drives of incriminating evidence."
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Anonymous Coward, 18 Mar 2013 @ 9:49am

The GM corn thing is all about money, GM corn is only better at yield when the proper chemicals are used to grow it.
It's also under patent so you have to go back to Monsanto to get seeds year after year.
Unlike in olden days when the farmer would let some of the crop go to seed to use in the following years.
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Michael, 18 Mar 2013 @ 9:53am

Re: Re: Transparency
the second one.
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mischab1, 18 Mar 2013 @ 9:55am

commercially-sensitive
Businesses only worry about "commercially-sensitive" info if they think it will reduce their sales.
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Anonymous Coward, 18 Mar 2013 @ 9:55am

typical attitude, particularly with any and all USA companies/industries, once the stupid politicians have granted them a monopoly, they want to keep it, fighting with all they can for everything to remain in their control. this is a typical 'the entertainment industries are doing it, then so can we' scenario! the worse thing is, those same stupid politicians will do whatever they can to help the monopolies be maintained! how can any company purport to support openness, then sue whoever they can to keep their monopoly?
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DannyB (profile), 18 Mar 2013 @ 10:14am

I shouldn't have to disclose how much I pollute
Disclosing how much I pollute the air, land and water with radioactive sludge is illegal, confidential and "commercially embarrassing".
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Ninja (profile), 18 Mar 2013 @ 10:21am

Re:
Collateral damage, no need to worry.

Signed: big pharma companies.
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Anonymous Coward, 18 Mar 2013 @ 10:22am

Re: Re: Transparency
There are already very strict rules in Europe about what information has to be included with the product, or the company will get asswooped. Therefore the inlay note always include cautious estimates about the sideeffects they have tested for!

Where this matters is mostly in the future when new ways of testing can show the dangers involved with the drug. Also, there may be several problems with timing patents with release of the information.

Most of all those are miniscule problems, but if a drug gets denied and the data are released, the administration can cost a company the invention when another company gets an improved version accepted first. It is not inconcievable that EU companies will get a little more leevay in that procedure and that is unfortunate. Earlier preferential treatment cost a company some money, now it can cost them a patent!
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DH's Love Child (profile), 18 Mar 2013 @ 10:23am

Re: Transparency
I wish there were a sad but true button.
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Anonymous Coward, 18 Mar 2013 @ 10:37am

Oh you can't find out how safe our product is. How silly that would violate patent laws.
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Wally (profile), 18 Mar 2013 @ 10:45am

Re: Re:
What we might call collateral damage, my wife calls the bloodbath of the century...
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Anonymous Coward, 18 Mar 2013 @ 10:46am

So bob, out_of_the_lube and that idiot copy-pasting staff would rather have another thalidomide incident occur than the sanctity of patent laws be possibly infringed upon. Well, I'm sold by that sheer logic.
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gorehound (profile), 18 Mar 2013 @ 10:59am

Re: They shouldn't have to release their data
If Big Pharma wants to argue about opening up the Studies so people can see only safety and efficiency Data then I say it only says you got something to hide.
And if this Data can not be released surely it can be Wikileaked by someone out there.

And I also would love to know more of the FDA Practices.I am still waiting to be able to have Proscribed the new Hep-C Treatment without Interferon/Ribavirin.Held up by the FDA or whatever.I have waited over ten years for a chance to not have to take a useless Interferon/Ribavirin Treatment.
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AndyD273 (profile), 18 Mar 2013 @ 11:19am

Isn't this stuff already disclosed somewhat?
At least in the US, you see a medicine commercial, and at the end they go over the possible side effects. "If you take this pill for your low back pain you could have swelling of the hand, dry mouth, and an oozing rash. In some rare cases people grew extra limbs, then died."

Is this a different type of disclosure?
I guess it could be the actual numbers of how many people actually grew a 3rd arm and then were strangled when it had a mind of it's own.
Or, at least how bad the rash oozed.
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PRMan, 18 Mar 2013 @ 11:21am

Re: Re: They shouldn't have to release their data
It's already out there.

The Amazing Revolving Door -
Monsanto, FDA & EPA

http://rense.com/general33/fd.htm
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Wally (profile), 18 Mar 2013 @ 11:31am

Re: I shouldn't have to disclose how much I pollute
It has a bit more to do with medications and how the react when mixed with others more than anything else. They want to make it easier for pharmaceutical technicians to screw up doses and for them not to be able to countermand a prescription if a doctor mistakenly prescribes medications that don't mix well. The pharma. tech's job in a drug store is to make sure that the information they see on medical labels is accurate. These labels tell them everything from chemical composition to the combined atomic weight of the compounds the pill carries. The pharmaceutical tech at a drug store has a background in Biochemistry and should know by looking at labels and diagrams of molecules what can and cannot mix.

More fun examples:
Sildenafil Citrate (generic name of Viagra) mixing with Nitrate-based heart medications because both are designed to lower blood pressure. Both relax the muscles surrounding the veins and blood vessels and open up more blood flow through the body. Too little blood pressure and you die.
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Anonymous Coward, 18 Mar 2013 @ 11:37am

How denying people the right to make, create, and take some substance that directly effects their health unless they can pay the racketeers and get their blessing or approval is not considered to be a violation of the individual's right to life still confounds me.
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Bergman (profile), 18 Mar 2013 @ 11:52am

There's a simple solution to this.
Pass a law that automatically classifies any drug that the company refuses to release safety data on as Schedule I.

They want to keep their secrets? Let them. But they won't be doing any business in the United States.
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Anonymous Coward, 18 Mar 2013 @ 11:54am

Re:
Patent law is based on revealing the invention in a patent. The only possible effect of transparency on patents is as prior art to invalidate a latter patent, in which case in was not a new invention.
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Anonymous Coward, 18 Mar 2013 @ 11:58am

Re: Re:
Only cyber has never meant anything...
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Anonymous Coward, 18 Mar 2013 @ 12:05pm

Except, of course, this isn't "confidential" and "commercially-sensitive" information: it's just basic data about its safety and efficacy.

Apparently this is an area with which you have limited familiarity. Perhaps the following (one of many) will help you understand why disclosure of such information to third parties can be quite problematic:

http://www.law.harvard.edu/programs/petrie-flom/workshop/pdf/epstein.pdf
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That One Guy (profile), 18 Mar 2013 @ 12:07pm

I can't be the only one thinking this...
But if they are going to claim that safety information is 'commercially sensitive', the only way that argument makes sense is if releasing the information would cause people to stop using the drugs, and doctors to stop prescribing them, due to how unsafe they were.
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special-interesting (profile), 18 Mar 2013 @ 12:10pm

A patient seeing a doctor is different from a subject in a clinical trial. Complicating that what were the conditions of the contract when they signed consent for testing a new drug? Privacy issues for each case are different. Even in publicly funded trials many wold not sign up without at least some level of privacy. They might have to pay more. A difficult sensitive issue.

You mentioned �key� information. You give your age, DOB, sex, and two of your prescriptions and thats enough to find your name.

On the side; the individual patient should have awesome privacy rights. An average patient visiting their local practitioner should have never entered into the database of the pharmaceutical firm at all. I hope privacy law starts to respect such sensitive areas with harsh treatment when violating the trust we share with our local doctors.

Claims of "firmly supports transparency"? Hahaha. -no bite-

More specifically; lets examine other aspects (imminent rant)

What do I care what drug firms say to me? It is my understanding that the big pharmaceutical firms would let people suffer and die because some over paid exec decided they could maximize profits. Take a modern stomach acid drug and charge $230 a month?

How does anyone trust a firm that has such a great marketing department that they can take two different products frequently prescribed together (saayy a decongestant and an ok antihistamine that together cost $6usd) and re-brand them and sell it for $90usd at your local pharmacy for 15 years. 1000s of people die every year because of high cost.

Of course they get away with it. Am I cynical? Yes! Very.

How do I express to my local congress-idiot that these people are not to be trusted and any augment from them thrown out. Just schmoozing with them is a no vote. These guys are the industry model for the **AA's anyway.
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art guerrilla (profile), 18 Mar 2013 @ 12:24pm

Re: Re:
Everybody knows for certain that Big Agra and Big Pharma have a LOT to hide.

FTFY
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nasch (profile), 18 Mar 2013 @ 6:49pm

Re: Re: They shouldn't have to release their data
I am still waiting to be able to have Proscribed the new Hep-C Treatment without Interferon/Ribavirin.

Side note, that's prescribed, which is almost the opposite of proscribed.
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nasch (profile), 18 Mar 2013 @ 6:55pm

Re:
You loose so much blood in these cases that you become dizzy and anemic during your monthly cycle to the point of fainting and blacking out.

One of the rare cases where either "lose" or "loose" works fine. :-)
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nasch (profile), 18 Mar 2013 @ 7:00pm

Re:
The GM corn thing is all about money, GM corn is only better at yield when the proper chemicals are used to grow it.

I wonder who sells those chemicals...
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Wally (profile), 18 Mar 2013 @ 9:41pm

Re:
You've never seen non-GM corn. Before genetically modified corn. Corn was the basic size as a blade of wheat. You know in Big, where Tom Hanks eats a "cocktail" corn? That my friend is non-GM corn. Corn was crossbred with Maze to get what we have today.

GM foods don't always have to be chemical based...it only means they modified the genetic code of a plant to enhance the size of the growth (tomatoes), or crossbred two different plants to make a new one (apricots are made from pare tree branches being grafted to an apple tree).

The problem is that companies are stupid enough to label these as patentable products when the latter of the methods has been around for hundreds of years.
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Wally (profile), 18 Mar 2013 @ 9:55pm

Re:
"On the side; the individual patient should have awesome privacy rights. An average patient visiting their local practitioner should have never entered into the database of the pharmaceutical firm at all. I hope privacy law starts to respect such sensitive areas with harsh treatment when violating the trust we share with our local doctors."

It's called HIPAA in the US....the Health Insurance Portablility and Accountability Act. That's the only data that needs protection...personal information about the patient. A lack of transparency concerning the patient in an emergency situation is extremely dangerous. Even in a clinical trial of a medication or procedure, a lack of transparency is strictly prohibited.

If a hospital had access to your insurance information from another hospital without your knowledge or consent, they would be violating the transparency laws provided in HIPAA.

Clinical trials need transparency, but not at the expense of the personal privacy of patients. Abbot Labratories is using that argument as a crutch to try to not pass on vital information to its rivals. HIPPA allows for your side effects to be reported in clinical studies, but people studying how you react are not, under any circumstance, allowed to disclose your personal information.
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Wally (profile), 18 Mar 2013 @ 10:02pm

Re: Re:
Admittedly that was a happy accidental spelling :-)
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Wally (profile), 18 Mar 2013 @ 10:08pm

Stoner
This whole situation is likened to a pair of stoners where one overdoses and the other is so tripped out that he can't tell the medics what they took because it interferes with his and his friend's buzz if they treat them.
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G Thompson (profile), 18 Mar 2013 @ 10:43pm

Re: Re:
latter of the methods has been around for hundreds of years

Thousands Wally, Thousands..

Cross-breeding/pollination/grafting of both plants and animals to create a better variant/hybrid has been around for thousands of years, though admittedly was more of a hit-or-miss situation.

it wasn't until Mendel (a monk) looked at pea's that people figured out.. Oh wow we actually have been doing things right but there is a better way too. Even kids in GOOD secular schools learn about Mendel's pea experiments.

It always amazes me when people think REAL carrots are actually long straight and orange, or that potatoes are actually the size of your fist (or bigger) and smooth oval shapes. Nothing could be further from the truth.
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G Thompson (profile), 18 Mar 2013 @ 10:45pm

Re: Re: I shouldn't have to disclose how much I pollute
I always thought the generic name of Viagra was Mycoxafailin

the things ya learn ;)
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G Thompson (profile), 18 Mar 2013 @ 10:52pm

Re:
Ah there's your problem. You're looking at a workshp paper that is called "The Constitutional Protection of Trade Secrets and Patents under the Biologics Price Competition and Innovation Act of 2009" [emphasis added] with it's first introduction line saying "Under federal law".

This is NOT occurring in the USA, this is occurring and about to happen in the EU.. USA statutes and/or constitution is absolutely irrelevant and more to the point moot.

Apparently international jurisdiction and that the USA is not the only place on Earth is an area with which you have limited familiarity - this is called parochial thinking.
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Wally (profile), 19 Mar 2013 @ 12:25am

Re: Re: Re: I shouldn't have to disclose how much I pollute
For the more pharmaceutical name:

Myacoxafallin

;-)
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Wally (profile), 19 Mar 2013 @ 12:27am

Re: Re:
Unfortunately this has nothing to do with patents and everything to do with Abbot Laboratories collaterally lobbying against patient safety concerning HIPPA laws.
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Wally (profile), 19 Mar 2013 @ 12:45am

Re: Re: Re:
I'm not sure, but I think potatoes are like pumpkins...size depend on where and how you grow them. Idaho potatoes grow as big as one's fist and generally look like asteroids without all the crags and craters here in the US.

Grafting was invented by the Chinese if I recall. Apricots anyone?

:-)
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NOT APPLICABLE, 19 Mar 2013 @ 6:25am

Re: Re:
My mum won't suspect that Monsanto and AbbVie have something to hide, because she is dead
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NOT APPLICABLE, 19 Mar 2013 @ 6:28am

What would Jesus say?
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nasch (profile), 19 Mar 2013 @ 7:34am

Re: Re:
Corn was crossbred with Maze to get what we have today.

Corn wasn't bred with maize, it's descended from maize. The word "corn" meant whatever the native grain is. In the new world, that was maize (which is closer to modern corn in size than baby corn), which they called corn, and now that's how we use the word.

GM foods don't always have to be chemical based...it only means they modified the genetic code of a plant to enhance the size of the growth (tomatoes), or crossbred two different plants to make a new one (apricots are made from pare tree branches being grafted to an apple tree).

GM does not include crossbreeding.

http://en.wikipedia.org/wiki/Genetically_modified_crops
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Anonymous Coward, 19 Mar 2013 @ 8:08am

Re: Re:
US requirements, quite similar to EU requirements, are relevant in addressing those who promote the mistaken notion that required disclosures do not include anything of business importance such as trade secrets and the like. This is simply not the case.
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G Thompson (profile), 19 Mar 2013 @ 10:24am

Re: Re: Re:
Let me put this in a way that you will understand.

The European Food Safety Authority (EFSA) is an independent legislative body established by the European Parliament (Regulation No178/2002)

basically they are the same as the US's FDA though with a lot more power to actual do what is in the best interests of consumers (since they are independent).

To have a food product authorised for use within the EU you have to submit to EFSA all your data. Due to EU data laws that data is PUBLIC ergo the data is public information that comes under the transparency regime that the EU has now put in place.

If there were secret confidential information in that data that the company did not want given to the public then they should not of included in in the files given. Its easy!

See the companies have a choice, either submit to the legislation or don't. Believe it or not the only winners in either scenario are the consumers, something that American law sadly seems to leave by the wayside.

Oh and as for US requirements being similar to EU requirements (or any other countries either) you are sadly mistaken especially when it comes to consumer and privacy laws.
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fred, 19 Mar 2013 @ 10:57am

Well yes, but to play devils advocate, the general public is not likely to approach risk factors in 'big pharma' products in an equally science based manner. Rather, such data could provide ammunition for commercial and ideological opponents inside and outside of the pharmaceutical industry, which monsanto et al. would be understandably reticent about providing. While the pharmaceutical companies clearly don't have our best interests in mind 100% of the time, that doesn't immediately mean that they just want to sell us poison. Indeed, it cant be said that we, as a whole, have our own best interests at heart.
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Wally (profile), 19 Mar 2013 @ 12:08pm

Re: Re: Re:
"Cisgenic plants are made using genes found within the same species or a closely related one, where conventional plant breeding can occur. Some breeders and scientists argue that cisgenic modification is useful for plants that are difficult to crossbreed by conventional means (such as potatoes), and that plants in the cisgenic category should not require the same level of legal regulation as other genetically modified organisms."

I think it would be best if you did not focus on entomology and semantics of words.
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nasch (profile), 19 Mar 2013 @ 1:12pm

Re: Re: Re: Re:
"Cisgenesis (from "same" and "beginning") is one term for organisms that have been engineered using a process in which genes are artificially transferred between organisms that could otherwise be conventionally bred."

Genes are artificially transferred... sure doesn't sound like crossbreeding to me.

I think it would be best if you did not focus on entomology and semantics of words.

That is rich coming from you.
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