Irmhild, as you know due to the question I posted earlier that I support your question here. May you/we find the answer to any organizations or agencies that are trying to solve this issue.

My concerns are:

1. Affordability to those who need the drugs no matter if they are in developing or developed countries,

2. without losing patent protection for pharma/drug manufacture's and continue to make a profit to pay for their research expenses, workers, etc.,

3 so that pharma/mfg's will continue to have incentive to do research and produce the drugs that are needed globally.

I am seeking global regulation to do this, so that drug producers/researchers continue to make profit, therefore incentive to continue to do research YET so that all may benefit from access to the drugs they desperately need. 

I do not know of any organization that may be doing this. But I suspect there are 'talks' due to the fact that India wants to produce drugs that are considered under patent and UK questions high priced drugs as well, so that drugs that are needed can be affordable.

Thank you again for posting this question.

I do believe someone in our RG community will have the answers!

Respectfully,

Jeanetta Mastron

There is harmonisation work ongoing all the time through the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (http://www.ich.org/home.html). For developing countries the WHO-EMA deal where EMA gives "approval" after scientific evaluation for drugs to be used outside EU (such as the malaria vaccine just announced) certainly helps countries without the capacity to evaluate the benefit-risk of new drugs to quickly get a drug out in use.

The problem of availability is slightly different I believe, the issue of high regulatory demands for licencing running up the costs are only a small part of it. The incentives to do research (that will always be very expensive, even if the regulatory part was relaxed) is related to patents, pricing and the need to prioritise what to research since companies do not have unlimited resources, both in terms of scientists and money and fail rates in developing compounds to drugs are very high.

Licensing / market authorisation is strictly guided to ensure that the drug effective and safe. There is a lot of guidance to what is needed, but there is also the possibility for drugs showing very good results to get approval under exceptional circumstances faster and with less data, the same goes for drugs for orphan diseases. 

The problem could be if different countries want completely different data to approve a drug, but I have never heard of this being a problem in developing countries? I might have missed it but I would think a US or EU or JP dossier would be sufficient in most developing countries? Probably less data as well but then you are back to the size of the market and the ability to pay.

Dear Mr. Svendsen,

Thank you very much for providing your comprehensive information.

You mentioned the fail rates of research and component development and optimizing causing high costs and requiring much time. This is one more new piece in our puzzle that really needs to be considered, you are absolutely right. Research results and intellectual property must be protected, but only under judicious and acceptable consensus, which is hard to achieve..

As far as I'm informed, esp. India has some regulations, which aggravate the licensing of already approved pharmaceutical in EU and USA (see links). Both publications are from 2014, so it's possible some changes have appeared meanwhile. The main reason are the high prices for instance of sofosbuvir of Gilead.Nearly the same in China with the possibility of compulsory licenses (see second link). Nevertheless there has been some improvement of business of the German Bayer company as well in China recently.

The so called BRIC nations with their legislation authorities, policy and pharmaceutical industry are making progress in harmonization, this is evident. Thanks to ICH among others for this approach!

Very positive and relieving to know, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use is undertaking so many global improvements constantly. I appreciate!

This is the right step and hopefully some more improvements will be taking place soon.

Respectfully,

Irmhild Rueter

http://www.forbes.com/sites/theapothecary/2014/09/09/indian-patients-suffer-from-indias-weak-pharmaceutical-patents/

http://www.reuters.com/article/2012/06/08/us-china-medicines-patents-idUSBRE8570TY20120608

Have a look at Pogge's 'Health Impact Fund'?

Dear Mr. Cockbain, dear All,

Thank you very much indeed, Mr. Cockbain! Very interesting.

For all who are interested in the "Health Impact Fund" to find out more about it, have a look at the link below. Sounds very positive and acceptable and could help finding ways to improve the situation of the pharmaceutical market and the global licensing system. I don't think they can make it on their own, if official organizations are not involved. But this fund performs very remarkable actions indeed.

One more interesting item is included in the upcoming trade contract the EU and USA are intending to negotiate as soon as possible, the TTIP. One chapter is also dealing with harmonizing and standardizing the licensing procedures for pharmaceuticals. It sounds very promising too and is a step in the right direction, I think ( see file below).

What is the opinion of  everyone? Do you think TTIP will be beneficial?

Most Respectfully,

Irmhild Rueter

http://healthimpactfund.org/

Dr. Rueter,

There seems to be a sharp difference of opinion between industry protagonists and some critics. This one is critical: http://www.atlantic-community.org/-/ttip-it-s-not-about-trade. Some are opposing the US Trans-Pacific Partnership (TPP) agreement on the basis of the secrecy surrounding its provisions as well as the negative impact on US workers of past international trade agreements. http://www.bbc.com/news/world-us-canada-32355086.

Without greater transparency about specifics, it is hard to form an opinion either way about TTIP. I worry that industry will be able to sue individual countries, e.g., India, on the basis of the TPP agreement for efforts to produce more affordable generic drugs for internal distribution or impose price controls on patent drugs.

The lobbying efforts and influence of Pharma in the US and elsewhere are well known. http://www.publicintegrity.org/2013/02/11/12175/opinion-big-pharmas-stranglehold-washington.

Thank you Dr. Cockbain, 

I listened to Thomas Pogge's 'Health Impact Fund' Reimagining pharmaceutical innovation | Thomas Pogge at TEDxCanberra, Uploaded on Oct 29, 2011

https://www.youtube.com/watch?v=rTMqGbTNkNg

Yes very interesting indeed!

KEY: Sustainability!

THE HIF rewards the innovator on the basis of the health impact it yields, over ten years. The innovator could select to do the traditional Patent-Proected mark ups or the HIF with each drug they make.

The above is a short summary of HIF option. 

This reminds me of the new way that the medicare [and to some extent some insurances] are starting to reimburse doctors based upon outcomes of prescriptions, compliance/adherence, procedures etc instead of flat rates of procedures etc. So if the patient is not getting better than the insurance does not pay as well or pay at all. Most MD's do not like this method. It is in infancy and for that reason I can not make a rational comment about it. 

Below is a short description of what I learned:

So there is incentive to treat with positive outcomes. No money for sales, but money for health improvement. This yields and incentive to make the drug accessible to those with low to no money! This means the drug companies may want to have MORE people using the drug which yields more being treated.

Brilliant! To get this started I think drug companies would keep more of their drugs on the traditional, but try a few drugs on the HIF to see how this works for 5 - 10 years. If this works well, we would find more drug companies going to HIF and therefore all people would have access at low price. 

This keeps innovations going. The HIF is voluntary and needs to be funded by governments. 

This was in 2011. I wonder how it is going trying to get a pilot drug company ! I think this could work, but it would take time to 'prove' to drug companies that they will be prosperous and to give it a try.

Respectfully,

Jeanetta Mastron

Dear Mr. Noble,

First of all thank you, that you have been cooperative on this very controversially discussed topic of  TTIP.  The first of your links with the article of the Atlantic Community resp. Mr. Baker, which is really very critical is a good example of the main opinion most of the people have about TTIP. There are a lot of doubts resulting in reservations. Mostly, people are mislead or uninformed, even though all information is available online. I can not agree with the article of the Atlantic Community. TTIP is desperately needed to boost and improve both economies of the EU and the USA  to make them more competitive vs. the Asian economy (China, Taiwan, Singapore, Korea). No regulations are added, they will only be harmonized and standardized, no jobs or incomes will be cut because of TTIP. In fact the jobs in production of consumers products are already gone for many years with the BIG leading industry displacing many jobs to Asia. That's the reason China is not involved in TPP (Trans Pacific Partnership), because China doesn't need such a contract and is one of the reasons it's necessary. I agree with the first comment on the article by Mr. Baker. Regulatory issues will be solved with TTIP.  What is wrong, if some concerns, among them pharmaceutical manufacturers, will benefit? TTIP is created to improve economic possibilities and development on all fields. The US economy is struggling for many years now, so is the EU economy. I don't know, if  TPP really such disclosed deal, but TTIP is not at all. This topic is really "a hot potato" I don't want to continue discussing about. For my opinion  TTIP is an important step forward improving not only trading conditions.

The third link to "Opinion" was no surprise. We all know the strong influence of the BIG dealers, esp. the pharmaceutical industry, in every country. Lobbyists are also very active for the automotive industry, insurances and ecological energy/products. The 5th chapter raises the question, what the Congress is seeking in return to huge sums of money they receive from the pharmaceutical companies. What the US Congress is intending with it's attitude I think is firstly: No one has ever proved this sums of money are really existing and if they are  that high; secondly: pharmaceutical companies are secret carriers in many and special ways; third: the pharmaceutical concerns are global players; fourth: they provide many jobs; fifth: they are important tax payers; sixth: they are quoted on stock exchanges and seventh: the government is trying to protect the US manufacturers in order to protect the US economy and intellectual property as well as protecting the jobs. The Congress is trying to keep the production of medical equipment and drugs in the USA, which is not easy. It's the same in Germany. It's not entirely true, that US citizens are paying the most for medicines, prices are mostly higher here in Germany. Health insurances in Germany are not permitted to negotiate drug pricing either. It's easy to figure out the reason for this: corruption and arrangements. Together  the pharmaceutical industry and the insurances  would have too much power to dictate the prices much stronger than it yet happens. I'm considering this article of "OPINION" very critically. It's a bit too much unilateral criticizing the US government and Obamacare. I agree with the second comment of Mr. Anthony and the fifth comment of "PharmacyChecker", the online pharmacies need to be taken in consideration as well. In Germany the situation is not much better, even though we have health insurances for everyone, they don't pay most of the "better" medical treatment and pharmaceuticals as well. Our physicians have a very low limit for prescription drugs and can not provide enough, if a patient is seriously ill. However our health- and social insurances are very expensive and much of our salary is consumed for them. More people than 20 years ago have a low income as well and many pensioners are living near to poverty level.

From all this it's evident once more, an improvement of pharmaceutical drugs availability and pricing is desperately needed. We have many good basic approaches with the WHO, the ICH, the BfARM in Germany (see link below) and the  "Health Impact Fund" in USA (see link second link below). Have in mind, that all this organizations, resp. their staff, are receiving a lot of money as well and all are NOT cooperating directly unfortunately.

A lot of communication is already going on, here on RG as well.

Thank you again for your suggestions, very interesting.

Most Respectfully,

Irmhild Rueter

http://www.bfarm.de/EN/BfArM/_node.html

http://healthimpactfund.org/origin/

dear jeanetta - they have found a trial candidate, a j+j drug in india. nonetheless, as i said to thomas, there are too many ways for pharma to game the hif scheme if it isn't watertight. j

Dr. Reuter,

Thank you for your insights. I have no "suggestions" only concerns in face of well-known pharmaceutical industry practices here in the US. If the U.S. Congress were to rescind its ban on state-imposed drug cost controls, which many recognize was the quid pro quo to obtain pharmaceutical industry support for so-called ObamaCare , I would alter my opinion about the influence of industry money on members of the U.S. Congress. Until Donald Trump began bragging about how, as a businessman, he routinely responded to politicians who came begging for his monetary support by making a "donation" . . . with expectation that his interests would be served. Before Donald Trump, there had always been the plausible deniability by politicians that such linkage didn't exist. Donald Trump reinforces the belief of many voters in the U.S. that their single vote count for nothing against the contributions of big businesses, such as the pharmaceutical companies, to politicians. There is also evidence of how these industries routinely use money to influence the prescription choices of physicians, the results of studies by researchers, and the creation of medical treatment guidelines. (If interested, I will be happy to provide links to studies in this regard). Reluctantly, I conclude that universal licensing laws for the production and distribution of  pharmaceutical products are important but maybe secondary to the more basic needed reforms. Licensing a product which is based on shoddy if not fraudulent research doesn't advance the greater good of society, IMHO. 

Thank you Dr. Cockbain for the J&J info on a trial drug in India!

Great! someone/pharma had to give it a try, and it had to be BIG pharma in order to cut their losses if they have any.

Please keep us all posted.

Thank you,

Jeanetta Mastron

Dr. Reuter,

In my response to your thank you note, I stated:

"There is also evidence of how these industries routinely use money to influence the prescription choices of physicians, the results of studies by researchers, and the creation of medical treatment guidelines. (If interested, I will be happy to provide links to studies in this regard)."

Today, I came across an excellent article in PLOS that contains analysis of the problem of the corrupting influence of industry on physicians, research organizations, and researchers. It provides many links to sources of evidence in this regard. See: http://blogs.plos.org/biologue/2015/08/13/the-fight-over-transparency-round-two/.

Scarey, isn't it, the extent to which the products which regulatory agencies approve and license for production and distribution depend on claims which reflect corrupt practices?

Hopefully, the regulatory agencies will embrace transparency as the best way to combat exaggerated or false claims. The PLOS article describes the struggle over transparency that has divided the scientific community and government regulatory agencies. U.S. Congressman Raul Grijalva is seeking to tighten congressional disclosure policies so that witnesses giving testimony will find it harder to hide their industry ties.

Dear Mr. Noble,

I totally agree with your remarks. Your reamrks are mentioning very important aspects.

For many years I'm watching some of  these incidents and I'm pretty aware of all the influence lobbyists and industry are using in the right places to succeed in reaching their aims. Just today I came across one more of these incidents (please check the link below).

All branches of trading are obliged to provide transparency as much as possible today, especially in foods we have very detailed specifications in the EU, which is self-evident for pharmaceutical products. But it seems to me, that the same regulations and application requirements for licensing processes for drugs are causing these corrupt methods in some way, because competition seems to be very tough in this global market of pharmaceutical products. This leads to the question why this competition is that fierce and adamant. Possibly because there are too many manufacturers and too many developing projects of  similar active substances are running at the same time, causing serious contests and expenses. For companies loosing the race high expenses are made for substances which will never succeed, because an other company was faster in developing and applying for license. Additionally all the generics available are causing a serious price competition, that's good on the one side to cut prices for patients, but bad on the other, because it's leading to a dilemma for the manufacturers. Of course they can dispose their licensed patents as pricey as possible, but that's the last opportunity if nothing else works for them, I think.

Additionally all the money spend by industries for influencing policy, physicians and research projects and so on must be compensated in profits, causing high prices additive to all other factors. But who or which authority could be able to stop such actions of influence by industries? I know one agency, that is BfRAM in Germany: http://www.bfarm.de/EN/Home/home_node.html 

But I'm not sure if there are also possibilities of any influence, which would be not surprising.

There are many reasons transparency is essential for regulatory agencies and authorities, it won't work out without. To work on such essential processes like licensing and price policy, resp. price fixing for pharmaceutical products (drugs), staff of high reputation and excellent education from all nations is mandatory needed. Nevertheless no guarantee for incorruptibility and plain dealing will ever exist. In our time money talks and the welfare of humans is hardly ever considered. This is scary! Fatally the pharmaceutical market for itself is handled in the same way as the petrol market or real estate for instance, even though the life, health and  well being of everyone is dependent on good and high quality drugs and new developments. All this is of deep concern for me, just as Mrs. Mastron is expressing in her question too (see second link).

Finally I must mention that I'm very interested in studies regarding influence of  pharmaceutical industries on physicians and studies of researchers which you mentioned. Thank you very much for your kind offer. If you find some time, could you please give me some examples? I'd be very grateful.

Most Respectfully,

Irmhild Rueter

http://www.aol.com/article/2015/08/18/fda-approves-female-sex-pill-but-with-safety-restrictions/21224387/?icid=maing-grid7|main5|dl26|sec1_lnk2%26pLid%3D1559838485

https://www.researchgate.net/post/Dear_All_Do_you_see_a_trend_here_Where_is_drug_research_going_How_can_we_get_more_drugs_to_those_who_need_them_but_who_cannot_afford_them#view=55cc26c160614bcda08b46ee

Dr. Rueter,

Here are the references that were listed in the PLOS blog I cited earlier:

References

[i] Wilson RF (14 March 2012) The Death of Jesse Gelsinger: New Evidence of the Influence of Money and Prestige in Human Research. 36 American Journal of Law & Medicine 295 (2010), Washington & Lee Legal Studies Paper No. 2012-19. Available: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2022128

[ii] Harris G (25 February 2005) 10 Voters on Panel Backing Pain Pills Had Industry Ties. New York Times. Available: http://www.nytimes.com/2005/02/25/politics/10-voters-on-panel-backing-pain-pills-had-industry-ties.html?_r=2

[iii] Deer B (06 January 2011) How the case against the MMR vaccine was fixed. British Medical Journal. 342 doi: http://dx.doi.org/10.1136/bmj.c5347

[iv] Thacker PD (20 February 2013) The Slow Pace of Success in a “Do Something Congress” Edmond J. Safra Center for Ethics Harvard University. Available: http://ethics.harvard.edu/blog/slow-pace-success-do-something-congress

[v] Kesselheim A (20 Sept 2012) A Randomized Study of How Physicians Interpret Research Funding Disclosures. New England Journal of Medicine. 367:1119-1127 DOI: 10.1056/NEJMsa1202397

[vi] Rosenbaum L (7 May 2015) Reconnecting the Dots — Reinterpreting Industry–Physician Relations. New England Journal of Medicine 372:1860-1864 DOI: 10.1056/NEJMms1502493

[vii] Steinbrook R (2 June 2015) Justifying conflicts of interest in medical journals: a very bad idea. British Medical Journal. 350:h2942 DOI: http://dx.doi.org/10.1136/bmj.h2942

[viii] Shulma S (March 2004) Scientific Integrity in Policymaking: An Investigation into the Bush Administration’s Misuse of Science. Union of Concerned Scientists. Available:       http://www.ucsusa.org/sites/default/files/legacy/assets/documents/scientific_integrity/rsi_final_fullreport_1.pdf

[ix] Grifo F (February 2012) Heads They Win, Tails We Lose: How Corporations Corrupt Science at the Public’s Expense. The Scientific Integrity Program of the Union of Concerned Scientists. Available: http://www.ucsusa.org/sites/default/files/legacy/assets/documents/scientific_integrity/how-corporations-corrupt-science.pdf

[x] Halpern M (February 215) Freedom to Bully: How Laws Intended to Free Information Are Used to Harass Researchers. Center for Science and Democracy at The Union of Concerned Scientists. Available: http://www.ucsusa.org/sites/default/files/attach/2015/02/freedom-to-bully-ucs-2015_0.pdf

[xi] Wihbey J (20 February 2014) Strange Bedfellows … and Fear of Broad Impacts of Mann/UVa Court Ruling. Yale Climate Connections. Available: http://www.yaleclimateconnections.org/2014/02/strange-bedfellows-and-fear-of-broad-impacts-of-mann-uva-court-ruling/

[xii] Clark A (25 February 2015) Why scientists often hate records requests. The shadow side of sunlight laws. Columbia Journalism Review. Available: http://www.cjr.org/the_observatory/why_scientists_often_hate_reco.php

[xiii] Kloor K (11 February 2015) Updated: Agricultural researchers rattled by demands for documents from group opposed to GM foods. Science Available: http://news.sciencemag.org/scientific-community/2015/02/agricultural-researchers-rattled-demands-documents-group-opposed-gm

[xiv] Kloor K (11 February 2015) Updated: Agricultural researchers rattled by demands for documents from group opposed to GM foods. Science. Available: http://news.sciencemag.org/scientific-community/2015/02/agricultural-researchers-rattled-demands-documents-group-opposed-gm

[xv] Flynn D (20 March 2014) Plant Biotechnology Industry Rolls Out Site to Address Top Consumer Questions. Food Safety News. Available: http://www.foodsafetynews.com/2014/03/plant-biotechnology-industry-wants-to-engage-with-consumer-with-answers-to-their-questions/#.VclrS3i1qUJ

[xvi] Hsu S (29 November 2010) Greenpeace accuses Dow Chemical, Sasol and P.R. allies of corporate spying. Washington Post. Available: http://www.washingtonpost.com/wp-dyn/content/article/2010/11/29/AR2010112903764.html

[xvii] Goldman G (20 February 2015) No Scientist Should Face Harassment. Period. Union of Concerned Scientists. Available: http://blog.ucsusa.org/no-scientist-should-face-harassment-period-637

[xviii] Hasemyer D (4 March 2015) A Weak Link to Harvard-Smithsonian Gave Star Power to Climate Contrarian Willie Soon. Inside Climate News. Available: http://insideclimatenews.org/news/04032015/weak-link-harvard-smithsonian-gave-star-power-climate-contrarian-willie-soon

[xix] Gillis J (21 February 2015) Deeper Ties to Corporate Cash for Doubtful Climate Researcher. New York Times. Available: http://www.nytimes.com/2015/02/22/us/ties-to-corporate-cash-for-climate-change-researcher-Wei-Hock-Soon.html

[xx] Emails released under the Freedom of Information Act by Harvard-Smithsonian Center for Astrophysics.

[xxi] Harris G (19 March 2009) Drug Maker Told Studies Would Aid It, Papers Say. New York Times. Available: http://www.nytimes.com/2009/03/20/us/20psych.html?_r=0

[xxii] Thomas K (4 November 2013) J.&J. to Pay $2.2 Billion in Risperdal Settlement. New York Times. Available: http://www.nytimes.com/2013/11/05/business/johnson-johnson-to-settle-risperdal-improper-marketing-case.html

http://www.nytimes.com/2008/01/31/business/31censure.html

http://www.nytimes.com/2008/01/31/business/31censure.html

[xxiv] Meier B (25 Oct 2012) Panel Says Medtronic Edited Product Studies. New York Times. Available: http://www.nytimes.com/2012/10/25/business/senate-panel-says-medtronic-edited-studies.html

[xxv] http://www.medscape.com/viewarticle/773376

[xxvi] Project On Government Oversight (Updated 10 August 2011) Frequently Asked Questions about Medical Ghostwriting. Available: http://www.pogo.org/our-work/articles/2011/ph-iis-20110620.html#sthash.DP4y9uLN.dpuf

[xxvii] Warrick J (24 February 2015) House Dems: Did Big Oil seek to sway scientists in climate debate? The Washington Post. Available: http://www.washingtonpost.com/news/energy-environment/wp/2015/02/24/house-dems-did-big-oil-seek-to-sway-scientists-in-climate-debate/

[xxviii] Huertas A (24 February 2015) Willie Soon’s Failure to Disclose Industry Funding for Contrarian Climate Research is Another Reason to Support Transparency. Union of Concerned Scientists. Available: http://blog.ucsusa.org/willie-soon-climate-research-disinformation-637

[xxix] Halpern M (24 February 2015) What Kinds of Scrutiny of Scientists are Legitimate? Union of Concerned Scientists. Available: http://blog.ucsusa.org/what-kinds-of-scrutiny-of-scientists-are-legitimate-638

[xxx] Guillen A (27 February 2015) Democrats’ climate probe brings ‘witch hunt’ accusations. Politico. Available: http://www.politico.com/story/2015/02/climate-change-study-funding-raul-grijalva-115568.html

[xxxi] Grifo F (February 2012) Heads They Win, Tails We Lose: How Corporations Corrupt Science at the Public’s Expense. The Scientific Integrity Program of the Union of Concerned Scientists. Available: http://www.ucsusa.org/sites/default/files/legacy/assets/documents/scientific_integrity/how-corporations-corrupt-science.pdf

[xxxii] Center for Science and Democracy: Union of Concerned Scientists (Undated) Federal Agency Fails to Protect Children from Lead Lunches Available: http://www.ucsusa.org/our-work/center-science-and-democracy/promoting-scientific-integrity/federal-agency-fails-to.html#.VaWa3pNVikr

[xxxiii] Union of Concerned Scientists (Undated File) Political Interference in Endangered Species Science: A Systemic Problem at the U.S. Fish and Wildlife Service. Available: http://www.ucsusa.org/sites/default/files/legacy/assets/documents/scientific_integrity/gunnison-s-prairie-dog.pdf

[xxxiv] Campbell EG (17 October 2007) Institutional academic industry relationships. Journal of the American Medical Association. 298(15):1779-1786. doi:10.1001/jama.298.15.1779.

[xxxv] Campbell EG (26 April 2007) A national survey of physician-industry relationships. New England Journal of Medicine. 356(17):1742-50. DOI: 10.1056/NEJMsa064508

[xxxvi] Moses H (13 January 2015) The Anatomy of Medical Research: US and International Comparisons. The Journal of the American Medical Association. 313(2):174-189. doi:10.1001/jama.2014.15939.

[xxxvii] Daniels J (29 February 2014) A generation at risk: Young investigators and the future of the biomedical workforce. Proceeding of the National Academy of Sciences. vol. 112 no. 2, 313–318, doi: 10.1073/pnas.1418761112

[xxxviii] Lexchin J (29 May 2003) Pharmaceutical industry sponsorship and research outcome and quality: systematic review. British Medical Journal. 326(7400): 1167-1170. doi: http://dx.doi.org/10.1136/bmj.326.7400.1167

[xxxix] Lexchin J (15 February 2011). Those Who Have the Gold Make the Evidence: How the Pharmaceutical Industry Biases the Outcomes of Clinical Trials of Medications. Science and Engineering Ethics 18(2): 247-261. DOI 10.1007/s11948-011-9265-3

[xl] Stamatakis E (2013) Undue industry influences that distort healthcare research, strategy, expenditure and practice: a review. European Journal of Clinical Investigations. 43(5): 469-475. DOI: 10.1111/eci.12074

[xli] Full House Committee on Oversight and Government Reform (2 June 2015) Full House Committee on Oversight and Government Reform. Available: https://oversight.house.gov/hearing/ensuring-transparency-through-the-freedom-of-information-act-foia/

[xlii] Jones N (2 June 2015) Statement of Nate Jones, Director of the Freedom of Information Act Project of the National Security Archive, George Washington University. Available: https://oversight.house.gov/wp-content/uploads/2015/06/Jones-GW-Statement-6-2-FOIA.pdf

[xliii] Cohen J (7 August 2015) U. of I. Officials Used Personal Email to Hide Discussions. Chicago Tribune. Available: http://www.chicagotribune.com/news/ct-university-of-illinois-private-emails-20150807-story.html#page=1

[xliv] Kloor K (6 August 2015) GM-crop opponents expand probe into ties between scientists and industry. Nature. Available: http://www.nature.com/news/gm-crop-opponents-expand-probe-into-ties-between-scientists-and-industry-1.18146

[xlv] Folta M (19 July 2012) Thoughts From A “Shill For Monsanto”. Science 2.0. Available: http://www.science20.com/kevin_folta/thoughts_shill_monsanto-92265

[xlvi] Joe Rogan Experience #655 – Kevin Folta. Available: https://www.youtube.com/watch?v=vW8U8ZAhGW8&feature=youtu.be&t=3m5s

[xlvii] Folta K (12 September 2011) Email titled: CONFIDENTIAL: Coalition Update.

[xlviii] Halpern M (6 August 2015) Twitter @halpsci. Available: https://twitter.com/halpsci/status/629409781397233664

[xlix] McCraw D (2 June 2015) Statement by David McCraw on Behalf of the New York Times. Available: https://oversight.house.gov/wp-content/uploads/2015/06/McCraw-NYT-Statement-6-2-FOIA.pdf

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