Review of the Therapeutics Goods Administration Public Disclosure Arrangements

Submission from health journalist Melissa Sweet and other contributors to the health blog, Croakey.

This submission aims to include the views of journalists and others with a concern for disclosure in the public interest (For more details on contributors see Appendices).

It represents a compilation of views. All contributors do not necessarily agree with all statements or recommendations in this submission.

The submission has been drafted with limited resources and in haste, and is intended to raise issues and questions that the review panel may wish to pursue further.

Context

The review should be considered within the wider context of increasing expectations internationally that public agencies should become more open and transparent. This reflects widespread frustration with a culture of secrecy and information-control that has infected many governments and bureaucracies, perhaps as a result of "corpora tis at ion" of government processes and cultures, and no doubt also in response to the demanding nature of the 2417 media cycle. The push for greater openness is also being driven and fed by online developments.

This extract from _new book, "WikiLeaks and the Age of Transparency" is relevant:

" . . . here's why the anti-WikiLeaks backlash is futile. The transparency movement is not going away.

Today, the wall between powerful elected officials and the people they want to represent has started to come down. In America, political campaigns at every level make strenuous efforts to engage in direct and open dialogue with their supporters. They hold special conference calls for political bloggers, they do live chats on Facebook, they respond to direct questions on Twitter, and they engage in video question-and­answer forums on Y ouTube. Much of this interactivity is aimed at showing that the candidate is "listening to the public" in the same way that a photo-op supposedly shows that a candidate cares about some

issue, but sometimes they even give supporters tools to organize themselves on behalf of the campaign and invite them to help shape their agenda. This behavior has become so commonplace in politics that we've forgotten how big a cultural shift it represents.

The change isn't only coming from campaigns and other organizations or figures opening themselves up from the top down. It's also being created from the bottom up, as we literally carry in our pockets and on our laps the ability to connect and collaborate directly with each other, without requiring permission from the people formerly known as the authorities. And when you combine connectivity with transparency--the ability for· more people to see, share, and shape what is going on around them--the result is a huge increase in social energy, which is being channeled in all kinds of directions.

Transparency-is the fuel; connectivity is the engine; a sense of oneself as a more effective participant in the democratic process (personal democracy, if you will) is the journey. What is emerging was a greatly expanded notion of the role of citizen not just as a passive consumer of political information and occasional voter, but as an active player, monitoring what government and politicians were doing, demanding a seat at the table and a view ofthe proceedings, sharing self-generated news of what was important, and participating in problem solving . . . . .

The explosion of capacity means that old practices of hoarding or hiding information, done sometimes for pragmatic reasons (it was too costly to make lots of copies) and other times to maintain a position of privilege, now seem like artificial barriers to access. In this new context, a political campaign that refuses to engage

· supporters in an interactive manner is .

now seen as overly controlling. A legislature that makes public documents available solely by printing them in binders and making people come to a basement office in the Capitol, rather than posting them online in searchable, downloadable form, is seen as being ridiculously secretive. Charging exorbitant fees to access public information, or preventing people from contributing their own knowledge, is seen as hopelessly behind the times. And a government body that monopolizes control of public data not only risks undermining trust in its actions. It also stands to lose out in the burgeoning new world of participatory democracy known as "we-government," where citizens are using connective technologies and public data to create whole new ways of identifying and solving civic problems."

(source: http://www.huffingtonpost.coml20 11 /02/09/wikileaks-assange­transparency _ n _ 820348.html)

Commenting on this excerpt, CEO of Lateral Economics, who chaired the Australian Government's Web 2.0 taskforce, added:

"And if these things seem principally 'rights based' one should never forget the economic contribution that can be made by people who are engaged and who can convey information from particular perspectives and with particular knowledge - sometimes high level scientific or practical knowledge that may not be available within an agency."

Cultural issues

The TGA, as other submissions have noted, is perceived as being closed, secretive and unwilling to engage in the public arena.

This was the general feedback from a number of journalists in response to a recent Croakey post calling for input to this submission 9http://blogs.crikey.com.au/croakey/2011/02/04/help-a-call-for­journalists-gov-2-0-experts-to-contribute-to-review-of-tga/).

The picture is of an organisation that hides behind its PR minders.

One Croakey contributor noted: "I have often said that the culture of the organisation is reflected in the building. In its isolated location it could be easily be mistaken for the nearby ACT prison! After you have passed the TGA perimeter fence, you have to cross the bridge over the moat to get to the high security entrance. (Of course, being Australia the moat is dry, but there are warning signs about the snakes which live in it!)"

To be fair to the TGA, similar criticisms are also made of federal, state and territory health departments. And as comments in the appendices from North American journalists and journalism organisations indicate, agencies such as the FDA are also criticised for not being sufficiently open and accountable.

The most fundamental recommendation of this submission is that there needs to be a cultural shift at all levels of the organisation to ensure that public engagement is valued and seen as core business, rather than being seen as something to be avoided.

Recommendation: The TGA engage with change management consultants and Gov2.0 i=ovators to revise organisational objectives and to foster cultural change. Perhaps senior executives' KPIs should include

some measure of their own and the organisation's engagement in the public arena, for example.

Process issues

Many journalists complain that they do not have access to TGA officials with the relevant expertise for stories they are researching. All requests must be put in email fo a PR consultant, who typically then provides a response in writing. This does not allow the to-and-fro questioning that helps inform constructive journalistic research. It also eliminates the possibility for journalists and TGA officials to develop effective relationships that can foster a useful exchange of information. There are many journalists who specialise in covering health, in both the mainstream and specialist media. Many have been covering the round for more than a decade and have a commitment to covering the round. It is to the TGA's detriment not to engage with these journalists, in particular.

There are also concerns of potential for conflict of interest, as the same PR consultancy has been covering the TGA as the Federal Department of Health. There is a sense among journalists that the politicallbureaucratic objectives of the department take priority.

The TGA has been criticised for a lack of transparency about who is involved in making what decisions.

Recommendations:

The TGA develop in-house media team that is committed to open engagement and helping to develop constructive relationships between key TGA officials and journalists. The TGA website should include the contact details of which TGA officials are responsible for which areas and who are able to take media calls.

The TGA should seek to proactively engage in public debate when issues related to therapeutic goods are in the news. A model to consider is the Behind the Headlines web-based analysis of news stories provided by the NHS.

Members of advisory groups and committees should be publicly disclosed on the website. Their declarations about conflicts of interest should be published. Details of meetings and meeting agendas should be published. Wherever possible, meetings should be streamed.

More specific recommendations come from an emergency physician in Canada, a professor in the School of Health Policy & Management at York University, and an advisor to many agencies and governments on medicines policy. He made these suggestions:

1. Drugs of concern (used by high-risk populations, potential for serious side effects, etc) should go to advisory committees that meet in public and all the material that the committee members see should also be public. (FDA does this)

2. Make public the names of all drugs that are being considered for approval.

3. If a drug is denied approval identify the drug and give reasons for not approving it. (EMA does this.) (Two reasons for doing this: first, the drug may be resubmitted later and it would be good to know what has changed; second, the drug may be related to one already on the market &

if the new one has problems then the one on the market may have some of those same problems)

4. Make public all clinical material submitted in the drug approval process plus the TGA reviewers' comments about that material within a reasonable time (say 3-6 months) after a final decision has been made. (FDA does this more or less but it often takes a while to get things posted.)

5. Make it mandatory to register all clinical trials (Phases I - III) on a publicly accessible database before the trials begin. In addition, make it mandatory to post the results of all trials on a publicly accessible database within a reasonable period after the trials have finished. (Already being done in the US except for Phase I trials)

6. Make public all Periodic Safety Update Reports that the companies submit.

Meanwhile, Clinical Associate Professor from Brown University Department of Family Medicine referred the review to this article that he co-authored in Archives of Internal Medicine (April 9, 2007), titled: "Avoiding the Regulatory Capture of the Food and Drug Administration" .

added:

"All results of all studies (raw data) should go up on the web after publication. There is plenty of hard drive space. All FDA reviews of approved nda's should go on the web. See rosenheck

Phase four trials should be run by a permanent data collecting network of HMO's and academic health centers. This will allow for permanent monitoring and specific nested case control studies."

Former FDA Commissioner, submitted (via Twitter): Important that TGA let the public know about products' risks, even when the TGA doesn't have the full answer.

Innovation and online engagement

It seems odd that a review of the TGA's website is being conducted separately to this review. Surely the website should be central to the disclosure of information and public deliberation about TGA policies.

Recommendations:

The TGA scope best practice internationally - whether from the public or private sectors, from health sector or beyond - in the online disclosure of information. It should include but not confine itself to investigating what other drug regulatory agencies are doing. One Croakey contributor suggested this FDA site as a useful starting place: http://www.fda.govlNewsEventslInteractiveMedia/default.htm

However, other contributors, particularly journalists in the US (see Appendices) raised many concerns about FDA culture and processes around transparency.

The TGA should convene a roundtable meeting to bring together TGA officials, Govt 2 and social media innovators, journalists, journalism academics, experts in the quality use of medicines, and others with an interest in public interest disclosure to canvass possibilities for innovation.

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Appendices

Contributors to this submission included:

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----------- -- ----- - - - - - -

A number of Australian journalists and Croakey contributors who wished to remain anonymous

The Australian newspaper

FDA Webview & FDA Review

Clinical Associate Professor from Brown University Department of Family Medicine referred the review to this article that he co-authored in Archives of Internal Medicine (April 9, 2007), titled: Avoiding the Regulatory Capture of the Food and Drug Administration.

a freelance reporter, who write for publications includingMedscape, Drug Topics, Contemporary Pediatrics and the American Journal of Public Health. She has covered the Washington health scene as a reporter/editor for specialized publications for over 30 years. Among other positions she was editor of The Nation's Health, the newspaper of the American Public Health Association for 14 years.

US health journalist, member Association of Health Care Journalists

•••• CEO of Lateral Economics, Web 2.0 commentator, and who chaired the Australian Government's Web 2.0 taskforce

former FDA Commissioner

an emergency physician in Canada, a professor in the School of Health Policy & Management at York University

••••• Globe and Mail health reporter, Canada, member Association of Health Care Journalists

Melissa Sweet, freelance health journalist and moderator of the health bl�g, Croakey

December 2009 statement from 11 major journalism organisations, including Association of Health Care Journalists, demanding greater transparency from US FDA. http://www .healthjournalism.orglabout -news-detail.php ?id=81

A report on research showing that more than two-thirds of health care reporters taking part in a First Amendment survey l1ave had stories held or left unpublished because the Food and Drug Administration did not respond to FOrA requests.in a timely manner. http://www .healthj ournalism.orglabout -news-detail. php?id=50

1. Comments from a newspaper health reporter

This person did not want to be identified (but can be contacted via Melissa Sweet if you would like to speak privately with this person)

(Note these comments are not for publication at Croakey)

- Meetings and committees seem completely opaque. It is not easy to find out who is on the TGA committees that make decisions, what their biographical history is, and what their potential conflict of interest is in terms of drug industry funding etc. This is out-of-step with best practice in the medical community Gournals etc).

- Meetings are not open, either through transcripts/minutes or streaming, meaning the decision-making behind decisions is not clear.

- Answers do not often address questions asked. We have to address all questions to the media unit at the DOH, rarely get to actually talk to the people involved, and instead get short, written responses that sometimes do not address all the questions asked.

- The web system for figuring out what devices/drugs are registered with the TGA is confusing and difficult to use. You need specific nameslbrands rather than just a type of thing (for example you cant search "baby pillow", you need the actual brand) which makes searching inefficient.

- The website is clunky and difficult to use.

- The TGA is not often proactive. Often issues are raised by the FDA or researchers in Australia and the TGA doesn't seem have anything to say about them. The FDA regularly sends out warnings/information

- It is slow. Often requests are made at lOam and we don't receive anything back until just before our deadline, which makes it very difficult to properly digest and include information.

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LJ£(lit(]lr, Weekend Health, The Australian

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· . .it would be extremely useful for the TGA to have its own media unit -as opposed t� and the health Dept - that's sufficiently staffed with people able to respond quickly to media requests for info or interviews with TGA experts. Ideally, the unit would encourage - not actively discourage, as is now the case -journalists to contact TGA experts directly.

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3. US health journalist, member Association of Health Care Journalists

The winning formula is simply an attitude that favors the free flow of information and believes reporters should talk to the people who know what's going on. I don't think it's merely an organizational matter. It's what they believe, what they're told their job is. Too often, they're told to keep reporters at bay and to control the message. This is a huge problem throughout the Obama administration, one that belies all the promises of transparency.

There are so many public agencies in the US, at the federal, state and local levels, it's hard to make generalizations about openness. But, based on your description, I don't think many are as secretive as your TGA. The idea of a public agency holding all its meetings behind closed doors would be shocking to most Americans. But we still face many obstacles to public access.

Each state and the federal government have laws promising access to public meetings and documents. These laws vary, but the general idea is that the public's business must be conducted openly. There are a few exceptions, such as personnel decisions and union negotiations. The Reporters Committee for Freedom of the Press has a lot of good information about these laws: http://www.rcfp.orglindex.php One of the ways that agencies skirt public-records laws is by taking so long to answer requests for documents - sometimes years -- that the information . sought is outdated or irrelevant by the time it arrives.

As you can tell from reading ABCl's Right to Know page (http://www .healthj ournalism.orgll stAmend-resources.php), our big struggle concerns access to federal officials. This is more a matter of practice and philosophy than law. We feel that federal media officers are often - though not always -- overly controlling and intrusive, and slow to respond to inquiries. Reporters have a hard time getting to talk with "subject matter experts." Even if they know the expert and he or she is

happy to talk, the expert has to get "clearance" from a public information officer, who can delay or prevent the conversation. Oftentimes reporters don't know whom to speak to, and that makes us dependent on the media offices, which can be highly bureaucratic and dismissive of regional media outlets. Some of them do what the TGA does - insist on written questions and provide written answers. Written responses are rarely adequate because they don't allow for follow-up questions and the two­way conversation that is essential for good reporting.

The federal government does do something that we like - holding telephone press conferences when there is a major announcement or development. This allows everyone, even the smallest outlets, to get information firsthand and to pose at least one question to top officials. The feds also have been building very informative web sites. The FDA sends out e-mail alerts to anyone who subscribes (so you can scare yourself silly hearing about every food recall). These are positive developments, but they don't substitute for enabling reporters to get all their questions ·answered.

One thing that worked really well for us was the meeting we had with state and local health officials; there's a link to a report about it on the

. Right to Know page. This meeting focused on public communication in a crisis, but the approach might work for other media issues as well. We talked about the reasons why public health officials are sometimes reluctant to give out information, and in so doing found a way to address each of those concerns. It was very helpful to just hash it out, to understand each other's motivations and reach some common ground. The guidelines that emerged from this meeting still haven't been formally approved by anyone, and may face further rewrites, but I'd be happy to send you a copy if you're interested.

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4. and Mail health reporter, Canada, member Association of .U."."lLll Care Journalists

Canada has an organization similar to the TGA called the PMPRB (Patented Medicines Prices Review Board).

We have similar issues such as lack of access to meetings, too much information deemed proprietary in reports, etc. But, in terms of media

relations they are not too bad. You might want to check out their Web site:

http://www.pmprb-cepmb.gc.ca <http://www.pmprb-cepmb.gc.ca/>

director of communications,

An organization that could serve as a model for good media relations is CIHI (Canadian Institute for Health Information). They provide all their material to journalists under embargo and CIHI officials are always available for comment, even on short notice.

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5. .DIUU,., FDA Webview & FDA Review (www.fdaweb.com) .

. . . .I emigrated from Australia in 1 974 precisely to savor the fruits of the world's only fully free press, especially so far as government agency reporting was concerned. In Australia it was a felony for a government employee to give information to a member of the press, with stiff jail terms the worst sanction. All government information had to come exclusively from the Minister, who was a politician whose primary concerns in this regard was to reflect credit on the Government and to make himself or herselflook good to the electorate back home.

What I found on arrival was exhilarating. Government employees at FDA (my area of primary interest) were only too pleased to talk with me about anything, and all knew their legal limits as to legitimate government secrets. It was amazing! Over the following 20 years I wrote literally thousands of stories about the inner workings and controversies at FDA for, at my peak, 14 different client publications around the world (Australia, New Zealand, Great Britain, Spain) and nearly 30 others in the USA (most state pharmacy journals, Drug Topics, Pharmaceutical Executive, Pharmaceutical Technology, Medical Device & Diagnostic Industry, Medical Marketing & Media). I eventually rose in the eyes of my confidential sources in the agency to the informal rank of "FDA' s unofficial journalist."

After the Oklahoma City bombing in 1995, tight security came to all federal buildings, and my access began withering away - not because I was a security risk, but because FDA management chafed at having so little control over me and other trade media reporters who had for so long

strolled their hallways unhindered. They refused to issue us press passes, as other federal agencies had. They relished the control over us that was falling into their laps.

By the 9/11 catastrophe, they had the perfect excuse to close any access loophole that might have survived - and they did, swiftly. We were the proverbial "dead ducks"! Since then it has gotten much worse. I am today working on an important story that the Press Office has been withholding information since last Thursday. They've seen a first draft, and have no incentive to answer my questions because it obviously would not reflect credit on FDA. So much for the free press guarantee in the First Amendment!

At least on the government reporting front, I might as well be back in Australia. Indeed I hope my Australian counterparts are able to at least make enough headway to mitke the land of my birth better than America in this respect. If! were not trapped by my age (70), I would go home and work there instead.

You may share this with anyone you think might be interested.

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6. health journalist in the US

Actually news gathering as it relates to the federal government agencies here is heavily censored.

Sotnetime between 10 and 20 years ago, depending on the agency, the government put the system of "minders" or "PR guards" in place.·

In contrast to administration prior to the early 1990s, agency employees are strictly forbidden to speak to any journalist without going through the agency's PR office.

Agencies give a string of justifications for this, but actual purpose is to stop any employee from telling us anything that deviates from the official story.

And, frequently, employees would tell us many things that deviate considerably from the official story AND are verifiable and important, if we could just get them away from the PR guards.

The system is driven in huge part by the desire of agency officials to look good and by the need of the political layers of government to manipulate public information for political gain.

Built on top of these restrictions are a host of barriers that are mind­blowing in a nation that considers itself a model for democracy, free speech, etc.

The PR guards don't answer our calls. Or they just refuse permission for any contact. Sometimes that's probably because they don't have enough guards for all the requests. And sometimes it's likely that officials don't want the questions answered.

These days in the Food and Drug Administration and other agencies, the PR guards almost always monitor every word of every phone call. They interrupt conversations to tell staff members what they can say and tell reporters what they can't ask.

Every conversation has to be pre-approved through layers of bureaucracy, including up through the political appointees. Staff members are given "talking points," before they are allowed on the phone, making sure they know what they may or may not say.

I estimate that the PR guard system has reduced contact between journalists and FDA staff by at least 90 percent from a few years ago, and much the same is true of other agencies.

Worse than that, perhaps, is the fact that when we are allowed to have contact, the information is likely so manipulated and sterilized, that --as with propaganda everywhere -- it's questionable whether it's a service or disservice to the public. Are we putting the endorsement of journalism on something so selective, spun or "fixed" that it is deceptive?

Journalists' vision has been so massively narrowed, so much of our perspective has been eliminated, that we have much less capacity for knowing or suspecting when something is deceptive.

Somehow we don't see this as censorship, because it doesn't reach into the actual publication process to stop information flow. I don't know. Maybe this system of stopping information -- and journalists' education-­at the source is even more effective.

2008, Testimony to FDA Risk Communication Committee

My name a freelance reporter. I write for publications including Medscape, Drug Topics, Contemporary Pediatrics and the American Journal of Public Health. I've covered the Washington health scene as a reporter/editor for specialized publications for over 30 years. Among other positions I was editor of The Nation's Health, the newspaper of the American Public Health Association for 14 years.

The way it used to be

Not too long ago a host of reporters reported on federal agencies in standard reporting fashion. We talked to people in the agencies. We got to know staff members. We developed source people. We called people and got 2-minute educations that vastly improved our stories. A very quick interview often turned a story from an empty shell, or something that might be misleading, to a solid piece that meant a great deal to readers.

Some specialized newsletter reporters regularly walked a beat in the halls of agencies, in the time-honored manner of local reporters.

Communication with agencies was almost constant for some specialized reporters.

And the process was absolutely vibrant. We got story ideas faster than we could scribble them down. We got a good understanding of what was happening. The experts in the agencies were like our graduate schools.

Nobody ever quantified or even studied those communications. Usually they were just a routine part of a staff member's day.

Then, about 12-14 years ago agencies began instituting a control mechanism:

Staff members in some agencies are strictly, emphatically forbidden from speaking to any press or media reporter, unless the reporter makes application with the public relations office and is tracked by that office. FDA is one of the worst agencies in the use of this control.

What happens now

This permission-to-speak system is simply the most horrible thing I have seen happen to governmental process in my time in Washington. It is severe censorship and very effective censorship. Agencies track, monitor, control and chill our conversations with staff.

We are prohibited from talking without government monitors overseeing every word. If this " government monitor" system sounds something from North Korea or China, I think it should.

Burdensome

This permission"to-speak mandate has probably killed over 90 percent of the communication that previously took place and should take place now.

It goes like this. A reporter who wants talk to a staff person - whether it's for 5 minutes or 2 hours - must call the public relations office. An assistant in that office tells the reporter someone will call back. The reporter waits. The public relations officer calls back, maybe in two hours, maybe a day, maybe not ever.

When the public relations officers get back, they want to know what the questions are, when your deadline is, etc. Then they often try to answer the questions themselves, without allowing you to talk to the source person. Sometimes they just say you can't talk to the person, because of reasons like the agency doesn't answer questions like that.

If the process goes forward, the public relations officer says he or she will get back to you, again, and then hangs up. What happens in the meantime, we don't know. Does someone else have to bless the conversation? Is there some process where insiders decide whether the communication is a good thing?

The public relations officer then gets back in two hours, three days, or never. There is no set time.

I have sat at my desk all afternoon while a physician expert sat at his desk, after he had already told me he would love to talk to me about technical medical provisions of a Federal Register notice. But our permission-to-speak never came.

If the reporter gets permission-to-speak, many times the public relations officer mandates that he or she will listen in on the conversation. So the officer goes away, again, to set up a time when all three parties can be on the phone.

And, increasingly, the public relations officers -those people whose job it is to make the organization look good-listen in on every word.

I don't see how this can be seen as anything but a cynical attempt to control reporting. It's burdensome to the point of all but killing the process. The education, the source building, the casual conversations that led to great stories, they are all eliminated now.

Usually, reporters don't call because they can't hold a story that long and they can't devote the absurd amount of effort to the application process, for a short discussion.

But it doesn't take a reporter to understand this. What business or other endeavor could survive a mandate of a multi-day, permission-to-speak application with a third party for every 5-minute conversation? What would that do to anybody's work?

The Monitoring

The burden of the process, by itself, is severe censorship. But that is not the worst of it.

The chill of the fact of the public relations officials tracking and/or listening in on every conversation is nearly universal and it is devastating. The communication a reporter has with a staff member is nearly always very different -less fluid, less informative- from what it is if we can ever get people away from the monitors.

Most Communication Is Benign

Ironically, the permission-to-speak system is also very counter­productive for public relations.

The great majority of the communication that has now ceased was benign, useful, and non adversarial from the agencies' own point of view. It was exactly the kind of information an agency wants to get to the public, including specialized publics like health professions.

Reporters, having to work very quickly, wanted to know: Does this rule apply to this population? What does this term mean in the context of this Federal Register notice? Can you give me any further background specific for my pediatricians? Is this the same program that came out last year or is it different? Can you tell me what this is about, in English?

Countless times agency staff members turned a story into something much more meaningful, by just talking to me for a short time.

However, Viva the Adversarial Press

On the other hand, there is a critical need for those conversations that some agency officials --or the political administrations -- are not comfortable with.

And, frankly, a number of reporters think it's those conversations that these rules were meant to control.

Uncensored, untracked conversations are necessary to prevent us all from being fed malarkey.

Remember, among other factors, the agencies will always want to look good and they will always be working for a political administration.

In addition to "untracked" conversations, "off-the-record" conversations are often absolutely indispensable to preventing the press and the public from being treated like stooges. If the current permission-to-speak rules had been in effect and adhered to in the early 1970s Watergate could not have been reported.

This is not a theoretical proposition for reporters, at all.

For example: Before the permission-to-speak system, one day I was on the phone with an agency staffer--an expert, the head of a program--for 30 minutes. The interview was not great but I had gotten my obligatory quotes and I was about to hang up. Then, just on a chance, I said, "Dr. XYZ, is there something you could tell me if your name weren't attached to it?" At that point Dr. XYZ exploded with information. It was as if a klieg light had come on in a totally dark cave.

And everything he told me was "public information." And it was confirmable. But not in a hundred years would a reporter or members of Congress have understood it without the help of an insider.

But that kind of guidance can be inconvenient or "not on-message" for the agency or the administration. Staffers have a keen sense of what the public message is and what they shouldn't talk about when the agency is listening.

When I finally got off the phone with Dr. XYZ, I was shaken at the thought of the story I would have written had I not gone off the record. It would have been sterilized to the point of deception. And I was shaken at the question of whether my profession is worthy of any public trust at all. Is what I spew out so misleading that it's worse than nothing at all? Does it just serve to lull the public into thinking that the official story has been confirmed and there's no need to question further?

But this is not just about an occasional event, or uncovering dramatic scandals. It's a constant, ongoing situation. Everyday, the conversations are more telling, vastly more educational when they happen away from the agency censorship process.

Something happened a couple years back that illustrated to me how much trouble we are in. An agency held a major media event to announce an initiative. But there was no initiative because there was nothing new, no new funding or new activity. This most certainly had to do with politics.

The media covered the event and gave it major play. No reporter understood the inside workings to question things that should have been obvious. No reporter could call staff without being tracked by the agency. And of the numerous staff people who understood the situation, no one tipped off a reporter, because they are forbidden to talk to us off the record and because staff people and reporters don't know each other any more.

That story went unquestioned in the mainstream media.

The important thing to notice here is how confident agencies seem to be that they can just put out a story, control the information and nobody will talk to each other, even though dozens of people know better. The press is flying blind and full advantage is taken of that.

Dangerous to let people communicate?

Officials say you can't allow just anybody to talk to the press. That's dangerous. That's not the official story.

It's against most reporters' standards and motivations to just talk to somebody or other and not confirm facts, not look elsewhere, not find out if they really have a story. Most of us are scared of looking like idiots when a better reporter gets the story straight.

Nevertheless, in an uncensored environment, bad things will happen. Some irresponsible reporters will talk to irresponsible staff members and irresponsible stories will come out.

Free speech, like democracy itself, is one of the messiest things ever thought of. The only reason we ever allow it, is that censorship. is thousands of times worse.

Rather than allowing only a few insiders to understand what is going on, free press and free news gathering are the only chance the system has to correct itself.

FDA News Recently

Many of the news stories about FDA recently have not been good. The reports often are about part of the agency not working well, so that the public is endangered, or that the agency does not have the resources to work properly.

Having been around Washington for so long, there are a couple of things I know. For most stories like that, there were a number of staffers who understood the problem for years. And, some of those staffers would have laid out a map of the situation for a reporter, if they could have talked without the monitors listening. And from there, the reporter could have gotten a fair, balanced story by talking to a number of other people.

In this country, reporting is a major part of accountability for the whole system. And that's been killed in these agencies.

And agencies are getting bolder about using this blockage. Recently an FDA public relations officer told me, "I decide if you can talk to him." (I never got to talk to him.)

This committee's charge is to look at FDA's communication to the public. If the agency controls who the press can talk to and what the press is allowed to know, it's keeping the public out.

The agency can spit out advisories, web materials, press releases and all kinds of materials. But if the press can't freely make calls and be there to have "unofficialized" conversations, then the trust in the information, whether it's about risk or about the agency itself, must be very limited.

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7. December 2009 statement from Association of Health Care Journalists

http://www .healthj ournalism. orglabout -news-detail. php ?id=81 .

Major journalism groups demand agency end newsgathering constraints

COLUMBIA, Mo. - Eleven major journalism organizations, representing thousands of journalists, are demanding the U.S. Food and Drug Administration end requirements that journalists and FDA employees notify or obtain permission from an agency official in order to conduct an interview.

The Association of Health Care Journalists, the Society of Professional Journalists, the National Newspaper Association, the Radio Television Digital News Association and several other journalism groups were joined by more than two dozen individual journalists in signing the letter sent to the agency's Transparency Task Force this week.

"These relatively new practices hinder reporters' ability to learn the truth by inhibiting and sometimes barring employees from providing essential information," says the letter.

The journalists also object to public information officers listening in on interviews.

"These restrictions have become increasingly widespread in federal agencies and other organizations," said president of the Association of Health Care Journalists. Reporters are forced to make an application, usually through the public relations office, for each conversation, however brief, and often must wait days for permission to speak to a staff member, he said. Even then, they sometimes have their requests ignored or denied entirely, he added.

More seriously, agencies insist on tracking, controlling and monitoring interviews. "That practice chills communication and inhibits public servants from sharing information with reporters," Ornstein said. "And it limits what the public is allowed to know about its government."

The groups wrote to the FDA's Transparency Task Force, which was created under the new administration, asking that it end these restrictions and set an example for other parts of the federal government.

The letter emphasized that although these restrictions have increased greatly in recent years, nearly all prior administrations allowed open, unfettered communication between agency employees and the media.

It has been during approximately the last two administrations that the rules have been implemented and grown steadily more constraining, according to journalists who have been reporting over that period.

"We are tremendously heartened by pledge to create an unprecedented level of government openness. It's in that spirit we want to tell the administration that it's not possible to do that and maintain these inherited constraints which did not exist under most administrations," said president of the Society of Professional Journalists.

The letter also stressed that public information officers can play an important role in answering questions and facilitating interviews, when requested to do so.

"But when they forbid, delay or monitor contact between reporters and employees, they interfere with the public's right to know," the letter said.

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8. Report on research of FDA handling of FOI requests

hUp:llwww.healthjournalism.org/about-news-detail.php?id=50 COLUMBIA, Mo. - More than two-thirds of health care reporters taking part in a First Amendment survey have had stories held or left unpublished because the Food and Drug Administration did not respond to FOIA requests in a timely manner.

Only a third of reporters said they received a response within the required 20 days called for in the federal Freedom of Information Act. Many waited months or years - or never received requested data, according to the survey and analysis conducted for the Association of Health Care Journalists by graduate students at Northwestern University's Medill School of Journalis

Nearly half of the reporters completing the survey said they were "very dissatisfied" with the FDA's processing of FOI requests, although only 15 percent ever filed complaints. Many said they were satisfied with the information they received, with a quarter of them saying the information resulted in major stories.

AHCJ is an independent, nonprofit organization of more than 1,000 health journalists dedicated to advancing public understanding of health care issues. Its mission is to improve the quality, accuracy and visibility of health care reporting, writing and editing. The survey is part of AHCJ's ongoing effort to track the responsiveness of federal health agencies to data requests from journalists.

Medill's graduate students, who conducted the research, were part of the journalism school's Washington, D.C., reporting program.

A student team traveled to FDA headquarters in Rockville, Md., to request documents from the reading room. Documents requested included a list of all FOIA requests made by journalists over the past 10 years.

Surveys and interviews were conducted with these journalists, as well as members of ARCJ. The survey received 169 responses, including 44 from reporters who had filed FOIA requests in the past five years.

The FDA fared poorly in this survey even in comparison to other federal agencies. Nearly three-quarters of those surveyed said their experiences were better with other agencies and about half said FDA officials contacted for help in fulfilling requests were unhelpful.

"As pressure mounts to increase funding and institute structural reforms at the FDA, increasing the agency's responsiveness to journalists must be made a top priority. Short of that, the agency cannot effectively be held' accountable to the public it serves," s

"aid ARCJ board member_

••••• chair of the association's Right to Know Committee.

While some reporters believe FDA understaffing is a problem, FDA officers said the number of requests made to the FDA annually has dropped significantly as more information is placed on the government Web site.

ENDS

• For more information about this submission, please contact Melissa

Melissa@sweetcommunication.com.au