Petrelis Files

Kramer, Bellman to Fauci, NIH: Release HIV Drug Panel Agendas & Minutes -- At No-Cost

(NIAID chief, Dr. Anthony Fauci.)

Here's the latest scoop on my continuing battle with the NIH/NIAID FOIA offices to pry loose almost 6,000-pages of agendas and minutes from the federal HIV drug advisory panel. Click here for the letter I sent to NIH asking fees to be waived.

The NIH has rejected my request for a fee waiver and is asking me to pay $600 to obtain records that should already be in the public domain, money I don't have and if I did, I would still appeal to the NIH, with its multibillion dollar budget in taxpayer dollars, to release the 6,000-pages for free. The issue here is much larger than the search and copy fees NIH wants me to pay, and that issue is the damn lack of full transparency of the NIH HIV drug advisory panel.

In its decade-plus years of existence, the panel has not held a single meeting open to the public, and PWAs, nor has it shared any agendas or deliberations. It's so secret it makes the old Soviet politburo conclaves seem like New England town meetings. And just like Soviet rulers, all the NIH HIV drug panel wants you to know only what their recommendations are for treating HIV, and they're not interested in not letting you know what clinical information, scientific arguments and decision-making were utilized to arrive at their guidelines.

Want to know when the HIV drug panel meets this year? It's not public information, comrade.

No public meetings, no transparency, no agendas and minutes already on the web, after more than a decade? Sorry, no $600 from me, if it were just lying around my bank account.

The HIV/AIDS leaders at the NIH, from top to bottom, must examine their policies on transparency for the entire AIDS research structure us taxpayers are paying for, with particular attention on the HIV drug panel.

Toward that end, I now share with you a letter from Larry Kramer to Tony Fauci, and another from Dr. Paul Bellman of NYC to NIH FOIA. Both advocate on my behalf to have the 6,000-pages released, at no cost, and I want to thank them again for doing this. You really learn who your friends are when you're demanding thousands of public records on HIV from the NIH.

Following the letters from Kramer and Bellman is the NIH FOIA officer's rejection letter to me.

Kramer's letter:

Date: 1/16/2007 8:17:45 P.M. Pacific Standard Time
From: Ned Weeks@aol.com
To: AFAUCI@niaid.nih.gov

tony, ms. cornell is evidently not aware how much additional time and energy and cost her turn-down of michael's request is eventually going to cost the US govt. michael is going to get those papers one way or another without paying for them and she could save america a lot of aggravation by just consenting to his request and stop making such picayune distinctions. honestly, that a mature woman, excuse me, person spent the amount of time dictating and writing this letter is remarkable. but just wait until michael will manage to usurp even more time of the bureaucrats down there until he gets this harmless stuff she appears to be defending so feverishly.

dont you just love bureaucracy! all this sounds like soviet russia. did you ever see or hear a menotti opera called the consul? it is a harrowing tragic story about helpless people in a communist country at the mercy of the susan cornells of this world.

we are shortly to be celebrating the 20th anniversary of ACT UP and the 25th anniversary of GMHC. amazing! i am going to make a speech at the gay center for the ACT UP anniversary. that is where we started. do you remember that room where we grilled you years ago when we were young?

xxxx
larry

This is Dr. Paul Bellman's letter to the NIH FOIA officer:

Susan Cornell
NIH FOIA Officer

Dear Ms. Cornell,

I feel it is important for me at the end of a long and busy day in my medical practice of HIV Medicine to let you know how I feel about the legal letter that you sent Michael Petrelis. In your letter you justified the DHHS's denial of his request for a waiver of a $600 fee which he cannot afford in order to obtain access to documents vital to his work as an HIV activist and journalist.

Michael is a leading and important activist for my HIV infected patient population in New York City. I don't think you understand, based upon my reading of your reply to Michaels FOIA request, the issues involved. I don't think you understand why he wants these documents and why he should be granted easy, speedy access to them.

Michael wants to know how clinical practice and research is shaped behind closed doors by government officials. He is worried that a possible lack of accountability, transparency and performance standards in the operations of government panels may be hindering the national and global fight against AIDS.

As a clinician and researcher in one of the epidemic's first epicenters in Greenwich Village, NYC, priveleged to care for many HIV infected individuals, I share what I believe to be his concern.

You may or may not know that many individuals serving in the DHHS including the DHHS guidelines people (who appear to have lifetime appointments) and the folks who serve on the AIDS Clinical Trials Optimization of Antiretrovirals Committee (OP ART) also receive outside consulting income from the very drug companies whose drugs they endorse to the medical profession and the public.

The powerful OP ART committee specifically decides what drugs to study in clinical research potentially leading to such endorsements. Although, the fees to these consultants may measure in the thousands to tens of thousands of dollars (the public doesn't know since the amounts are not disclosed) the amount of money drug companies spend on these consultants can be leveraged into literally hundreds of millions of dollars of revenue.

When questioned about these financial relationships these folks say that their disclosure of potential conflicts of interest is consistent with standard approved practices. I for one would like to know if there are such documents that make potential conflicts of interest okay as long as they are disclosed. The interest public certainly desrves to know if these potential conflicts of interest are ACTUALLY impairing the performance of these publicly funded panels.

Michael Petrelis, given his long history as an AIDS activist is uniquely equipped to be able to use the materials he requested and question whether the needs of the HIV infected community are being met and to report on his findings as a journalist and blogger.

I can disclose to you my belief here. The needs of the HIV community could be better met if there was more transparency, accountability and performance standards. Much of the critical progress made in the late 80's and early to mid 90's was due to a vibrant activist community including Michael Petrelis and a government, industry, and medical community that was interested and responsive to their needs and demands.

I questioned in a recent letter published in the Lancet why the head of the OPART committee (also a paid consultant to Glaxo Smith Kline), Dr. Joseph Eron, was also the principal investigator of a GSK sponsored study called of all things "The KLEAN study". The Klean study showed that GSK's drug Lexiva when boosted with Norvir was not inferior to Kaletra, which had received the DHHS guidelines panel's endorsement as a preferred treatment.

As a result of this expensive study that also utilized some of the infrastructure of the AACTG, GSK won an endorsement for its protease inhibitor Lexiva from the DHHS guidelines panel as a first-line treatment along with Kaletra. By placing GSK's drug into the elite preferred category, GSK stands to boost sales and profits by up to a hundred million dollars per year. Of note Lexiva/Norvir was not better than Kaletra just non inferior.

In my opinion, (not shared by Dr. Eron or GSK) this was a wasteful study that yielded results exactly in line with previously done studies. Of great importance is that Dr. Eron neglected to mention in his Lancet article, his presentation at the International AIDS Meeting in Toronto or even in his interview on AIDSmeds.com (a patient education website) that there was one key difference between GSK's treatment and its competitors. Lexiva when boosted with Norvir is $5400 dollars more per year than Kaletra.

My interpretation of this example is that our government supported research that increased its costs of care without improving its quality.

In his response letter to my Lancet letter, co-written with a GSK employee, Dr. Eron defended his work both for the NIH and GSK as properly disclosed according to current standards of disclosure for potential conflicts of interest.

At a time in which HIV patients on state ADAPS are dying on waiting lists while the same ADAP pays $5000 dollars more per year for GSK's non inferior drug, Michael Petrelis needs more info on the workings of these panels so that he can inform the public if there is something that needs investigation and real disclosure.

You should also know that many leaders in the medical and scientific profession including the current Editors in Chiefs of Nature and JAMA have taken a strong stand against expert panel members receiving consulting income from drug companies.

In addition two prestigious former Editors in Chiefs of the New England Journal of Medicine Doctors Jerome Kassirer and Marcia Angell have written books citing numerous examples of how this practice has led to tainted medical advice and inferior research. Because the HIV medical professionals who serve on the OP ART Committee and DHHS Panel have continued to reject the call by senior colleagues such as Doctors Angell and Kassirer, to stop the practice of outside consulting it is that much more important that the public get access to the workings of these panels.

I can't tell you how narrow the segment (your term) of the population that is be concerned about potential conflicts of interest, and transparency, accountability and performance of DHHS/NIH panels. I can tell you, however it includes my HIV infected patients in NYC and their families, employers, community organizations and friends.

Finally given what's at stake for the public health, the obstruction of Michael's efforts. because as a disabled HIV infected patient he can't afford the FOIA fee, is both ludicrous and cruel. It is also symbolic of an unfeeling and arrogant mentality, hardly I am sure what anyone involved in HIV work in the DHHS or NIH wants to convey to the HIV infected population. I hope you reverse your decision without creating more hoops for Mr. Petrelis to jump through.

Sincerely,
Dr. Paul Curtis Bellman
St. Vincents Hospital- Department of Medicine
Cornell Weill Medical College- Department of Immunology
99 University Place
New York NY 10003

And here is the rejection letter from the NIH FOIA officer:

January 4, 2007

Mr. Michael Petrelis
San Francisco, CA

RE: NIH FOI Case No. 32469

Dear Mr. Petrelis:

This is regarding your Freedom of Information Act (FOIA) request dated April 3, 2006, addressed to the FOIA Office, National Institutes of Health (NIH) and your follow-up letter dated December 18, 2006, addressed to Ms. Karin Lohman, National Institute of Allergy and Infectious Diseases (NIAID). In your FOIA request you requested various records related to the Panel on Clinical Practices for Treatment of HIV infection, which operates under the auspices of the NIH’s Office of AIDS Research Advisory Council. In both letters you asked that you be characterized as a member of the media for purposes of assessing FOIA fees and also that all fees associated with your request be waived. Your request for a fee waiver will be addressed first.

Department of Health and Human Services’s (DHHS) FOIA Regulations, 45 C.F.R. Part 5, set forth the standard for waiving fees associated with processing and responding to FOIA requests. It is the policy of DHHS to waive or reduce fees if disclosure of the requested information meets both of the following tests: 1) it is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government; and 2) it is not primarily in the commercial interest of the requester.

In analyzing the public interest, we consider the following factors:

1. How, if at all, do the records to be disclosed pertain to the operations or activities of the Federal government;

2. Would disclosure of the records reveal meaningful information about government operations or activities? Can one learn from these records anything about such operations that is not already public knowledge?

3. Will the disclosure advance the understanding of the general public as distinguished from a narrow segment of interested persons?

4. Will the contribution to public understanding be a significant one? Will the public’s understanding of the government’s operations be substantially greater as a result of the disclosure?

You have not demonstrated that disclosure of the requested information to you at no cost is in the public interest. You make a blanket statement that disclosure of the information will be of assistance to people with AIDS and their caregivers, but do not provide any further support for that statement. You further state that you should be awarded a fee waiver because you seek these records to share with your own physician and others regarding your personal situation. Such use is not the basis upon which a fee waiver can be granted.

Further, other than state that you maintain a blog and contribute to a monthly magazine, you have not demonstrated how you intend to disseminate the requested information to the public at large.

Finally, NIH and NIAID publish a great deal of information regarding AIDS and treatment options and you have not demonstrated how release of the requested information will add to the information already in the public domain or contribute significantly to public understanding of government operations.

Because you have not provided sufficient information to satisfy factors 1-4 above, I have determined that you are not entitled to a waiver of fees. Regarding your request to be characterized as a member of the media, you have not presented sufficient information to change our initial determination that you be charged for FOIA fees as a Category III or “other” requester. Simply maintaining a website or blog or writing opinion pieces does not qualify one as a representative of the news media. Rather, representatives of the news media use their editorial skills to turn raw materials into a distinct work. In addition, the language of your letter reveals that your primary purpose for requesting this information is to share it with your physician and others in order to make more informed decisions regarding your own health.

In conclusion, you have not demonstrated that you are entitled to a waiver of fees associated with responding to your request nor have you demonstrated that you should be characterized as a member of the news media. Therefore, we shall charge you for FOIA fees as a Category III requester. As such, you will be charged for duplication at 10-cents per page although the first 100 pages are free; 2 hours of search time are free and thereafter search time is charged at the hourly rate ($19.00, $38.00, $69.00) of the searcher; there is no charge for review time. At this time NIAID estimates the fee for responding to your request to be approximately $600.00. That estimate includes search time and duplication costs. If you agree to pay the fees associated with our response, please confirm that in writing to Ms. Karin Lohman, NIAID.

It is my understanding that you have amended your request, by breaking it into several requests each seeking two or three years of records. Please be assured that we are diligently processing -your request and will focus on making a response for documents from 1995-1997 as soon as possible after we resolve the fee issue.

You have a right to appeal this decision to deny you a waiver of fees and the determination that you are not a representative of the news media. Should you wish to do so, you must send your appeal within 30 days of receipt of this letter to the Deputy Assistant Secretary for Public Affairs, United States Department of Health and Human Services, Parklawn Building, Room 17A-46, 5600 Fishers Lane, Rockville, Maryland 20857, following the procedures outlined in Subpart C of the enclosed DHHS FOIA regulation, 45 CFR Part 5. Please mark both the envelope and appeal letter “FOIA Appeal.”

Sincerely,
Susan R. Cornell, J.D.
FOIA Officer, NIH
Building 31, Room 5B35
9000 Rockville Pike
Bethesda, MD 20892