Shooting War Gen-We Getting A Grip Wolves In Sheep's Clothing

B07473

Hopium
Profile

Liam

rank: Rebel
points: 145
occupation: Journalist
location: US
Info

Subscribe
Unsubscribe
Status
Info

biography:
Liam Scheff - Writer and Journalist on Politics, History, Race, Class and Culture.

In 2004, I broke open the NIH clinical trial scandal - government researchers testing New York City orphans with combinations of toxic, speculative drugs. My research was used as the basis for the 2004 BBC film "Guinea Pig Kids."

I've been published in city weeklies in New York, Los Angeles and Boston, in the book "Tutto In Ventita" (NewWorlds Media - Italy, 2005), and in other print and web journals.

website:
liamscheff.com/

photos: www.flickr.com/photos/liamsphoto/sets/

Email me:
liamscheff@yahoo.com

currently reading:

Too much at once, like the rest of you.

blog

Liam Scheff at GNN

NY Times To The Rescue!

B07473 / Sat, 16 Jul 2005 14:11:33 / Human Rights

Just when you thought that those poor folks at the NIH and Columbia University could find no one to stick up for them for using orphans in clinical trials….Here Comes The New York Times!

So, Are Columbia University and the NIH the good cops for offering AZT to orphans through no-chewing-required tubes?

Or, am I the bad cop for blowing the whistle on forced-surgery on orphans as part of AZT and Nevirapine Trials?

Read on and see….

Once you’ve figured it out, feel free to write me at liamscheff@yahoo.com

and/or write the New York Times, for making us all feel better about not worrying about it:

letters@nytimes.com

In response to NY Times article on ICC

Dear Editor,

Thanks for covering the Incarnation Children’s Center story.

You might have showed a little bias in your reporting, however.

If I didn’t know better, I’d say from reading what you wrote that I, Liam Scheff, independent journalist, somehow managed to get everyone who covered the story – the Alliance for Human Resource Protection, the New York Post, the UK Observer, the Associated Press and the BBC – all to dispense with their fact-checking and research departments and take my ‘word’ for what I discovered at ICC.

That’s quite a remarkable story.

I’m sure you’ll stick to it, but it’s far from true.

Your piece claimed that I presented no ‘official evidence’ in my reporting on Incarnation Children’s Center. In fact, I’ve presented piles of official evidence – NIH clinical trial documents, drug manufacturer’s package inserts and warning labels, multiple citations from the Physician’s Desk Reference, NIH and FDA policy papers on the use of wards of the state – to name a few.

You wrote that I made claims in my article about the death of two children at ICC. I was reporting from sources, one of whom I made available to the New York Times reporters after they interviewed me. I stand by that claim, and those sources.

You generously quoted Dr. Stephen Nicholas on the helpful nature of AZT in preventing mother-to-child transmission of AZT. You didn’t, however, bother to quote the medical literature.

There are several studies on AZT and transmission. The NIH study Nicholas quoted (ACTG 076) is the only one with a significantly favorable outcome. Other mainstream studies on AZT rate it similiar to or worse than placebo or no treatment regarding maternal HIV transmission (for a list of citations on AZT see http://www.aras.ab.ca/azt.html ).

You also omitted reporting on the consistent downgrading of AZT (also called Zidovudine) in the medical literature – from “life-saving AIDS drug” to a drug which actually increases the rate of disease progression and death in children born to mothers who were given AZT. (see below)

There are so many contraditions in the medical literature regarding AZT and other AIDS drugs, you have to work hard to ignore them.

Finally, you did not mention that I interviewed the medical director of ICC Dr. Catherine Painter, who told me, in no uncertain terms, how the medication regimen would be enforced if a child was unable to swallow pills which tend to cause abdominal distress (vomiting and diarrhea). The method, I was told, is a surgery to implant a gastric tube into the abdomen of these children, for the purpose of strict adherence to the drug regimen.

It’s one thing to say that AZT is a life-saving drug and that these orphans have been treated with the highest standard of care. It’s another to print it as fact in the pages of the New York Times, without reporting the significant evidence to the contrary. Instead of digging to the roots of this story, you have instead successfully colored it against further investigation in your pages. And that’s a shame for people who think you really are the paper of record.

Sincerely,

Liam Scheff
Independent Journalist
Seattle, Washington

Here are some examples of AZT in the med lit

“The probability of developing severe disease at 3 years of life was significantly higher in children born to ZDV+ [Zidovudine, AZT treated] mothers than in those born to ZDV- [no AZT] mothers…The same pattern was observed for severe immune suppression…

Finally, survival probability was lower in children born to ZDV+ [AZT treated] mothers compared with children born to ZDV- [no AZT] mothers.
Rapid disease progression in HIV-1 perinatally infected children born to mothers receiving zidovudine monotherapy during pregnancy. AIDS. 13(8):927-933, May 28, 1999.

“Children of study women who were prescribed ZDV [Zidovudine, AZT] had increased adjusted odds of any anomaly…[T]he lack of data on potential adverse effects of this therapy is still a concern….

Babies whose mothers had ZDV [AZT] exposure during pregnancy had a greater incidence of major malformations than those whose mothers did not.
Newschaffer CJ et al. Prenatal Zidovudine Use and Congenital Anomalies in a Medicaid Population. J Acquir Immune Defic Syndr. 2000 Jul 1; 24(3): 249-256.

“The study cohort included 92 HIV-1-infected and 439 uninfected children…Antiretroviral therapy (nonprotease inhibitor) was independently associated with FTT [Failure to Thrive] in our cohort…
ZDV [Zidovudine, AZT], in particular, alters mitochondrial metabolism and may have direct nutritional effects

Miller TL et al. Maternal and infant factors associated with failure to thrive in children with vertically transmitted Human Immunodeficiency Virus-1 infection: the prospective, P2C2 Human Immunodeficiency Virus Multicenter study. Pediatrics. 2001 Dec; 108(6): 1287-96.

terrible bad average good great Vote: vote   Avg: 4.05   Votes: 22   Comments: 17 [Add]

RECENT COMMENTS

MY GOD!

Does the NY Times have no shame?

It appears as if they never read your original report on this matter, or your follow-up report, or the Guardian report that confirmed your findings.

Why didn’t they mention that you investigated this by going under cover into ICC yourself?

Why don’t they mention that you interviewed the medical director of ICC, Dr. Catherine Painter? Why do they act as if you made up this entire story out of thin air and duped The NY Post, The BBC, and the Guardian of London?

Scheff, YOU EVIL GENIUS YOU!

I would have never guessed that those gigantic news organizations, with their large corporate budgets, would lack the capacity of fact-checking.

The NY Times will certainly receive a letter from me – on Monday – pointing out the mockery they have made of true, authentic, investigative journalism.

Their claims are so flawed it is laughable. Good job Liam!

mkane @ 07/16/05 21:42:44

Check this out.

No wonder the NIH can get mixed up in the forced drugging of orphans.

44 Violated Ethics Rules, NIH Director Tells Panel

Connections to big corporations.

in The NY Times as well

mkane @ 07/17/05 07:45:39

The Thimerosal parents and Robert Kennedy Jr. were just shafted by the NYTimes, So I did some checking and found out some of thier board of directors also sit on the board at Big Pharma.

NYTimes just did a huge story on thimerosal and neurodevelopmental disorders. I was shocked that they were not reporting facts about the dangers. So I looked up the Board members to see if there are any connections to Eli Lilly or other Big Pharma, Yes.. of course there is. I also am sending Robert Kennedy Jr’s web site on Thimerosal and the secret meeting between the CDC and big pharma… Kennedy goes into full detail. You want the truth about whats going on, please read Kennedys site! This is the WORST corporate crime known to human nature, Abuse of children, some who were left severe/profoundly disabled for life!

On Autism’s Cause, It’s Parents vs. Research http://www.nytimes.com/2005/06/25/science/25autism.html?hp&ex=1119758400&en=6e0\ 932b54736c849&ei=5094&partner=homepage\ 932b54736c849&ei=5094&partner=homepage

The board of directors at NYT;
Raul E. Cesan he became president of Schering Laboratories, the U.S. pharmaceutical marketing arm, and in 1994, became president of Schering-Plough Pharmaceuticals. (Im sure he still owns stock in pharmacuticals)

Ellen R. Marram
Ms. Marram also serves on the board of directors of the Ford Motor Company and Eli Lilly and Company. [Eli Lilly is the makers of thimerosal]

William E. Kennard
Mr. Kennard joined The Carlyle Group, a private equity firm, in May 2001 as a managing director in the global telecommunications and media group.

Henry B. Schacht
Mr. Schacht also serves on the boards of Alcoa (Aluminum Company of America), Johnson & Johnson and Lucent Technologies Inc.[Johnson & Johnson is one of the compaines that makes rhogam that injected pregnant women with mercury/thimerosal]

Cathy J. Sulzberger
She was also an editor of Consumer Drug: Digest: American Society of Hospital Pharmacists and Medication Teaching Manual: National Association of Retail Druggist, and a Consumer Editor of the Journal of the National Association of Retail Druggists.

http://www.nytco.com/company-directors.html

Executives Corporate Officers

Neal Roberts
Vice President, Organization Development
The New York Times Company

Previously, Mr. Roberts was vice president of global organization effectiveness with Hoechst Marion Roussel, the fifth largest global pharmaceutical company. There, he directed organization development consulting initiatives providing services to all commercial regions and global functions located in France, Germany and the U.S. in support of the execution of global strategies and the cultural integration of three merged pharmaceutical companies.
http://www.nytco.com/company-executives-nroberts.html

Robert Kennedy Jr, has been some what of an advocate about the dangers of thimerosal, Here is Robert Kennedy Jr’s website of the facts behind thimerosal, the cdc, big pharma cover up! Some of these children are severe/profoundly disabled from this, including my son. http://www.robertfkennedyjr.com/docs/AutismHgPolitics_6_23.pdf
Liam @ 07/17/05 13:03:50

Last comments on Robert Kennedy were received by email – not mine, but sent to me.

Liam @ 07/17/05 13:04:47

WOW! LIAM!

That’s what you look like?

For some reason, I always thought you had the mug of Condi Rice.

anyway, I said the NY Times would be hearing from me and now they have. My letter has been published at FTW, and is now undersigned by Mike Ruppert and Dr. Jamey Hecht.

Read it here

mkane @ 07/19/05 18:42:53

WOW! LIAM!

That’s what you look like?

For some reason, I always thought you had the mug of Condi Rice.

anyway, I said the NY Times would be hearing from me and now they have. My letter has been published at FTW, and is now undersigned by Mike Ruppert and Dr. Jamey Hecht.

Read it here

mkane @ 07/19/05 18:43:44

Well done, Liam.

Too bad they ultimately get the last word – being the Times and what not. You want to provide some contact info so we can all make sure that they make the correction?

Porktamer @ 07/22/05 07:19:45

You know, before I read Kennedy’s report, I had some doubts on this. Not any more; it’s obvious on the face of it that using mercury in a public health product is probably one of the stupidest things ever done. I don’t know how long it will take before this whole thing comes out in the national press; considering that the results of the Lancet study were only incompletely covered, and considering that there are Marines in the tri-border area in South America and I have yet to see a single story on it, I have to question whether it will ever make it into the mainstream. But keep on truckin, man! And thanks for your effort.

Schneibster @ 07/22/05 14:05:59

Seven Unpublished letters to the New York Times Re: AIDS drug / vaccine experiments on babies / children in NYC foster care
1. THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
www.ahrp.org
http://www.ahrp.org/children/NYTimes0705/UnpublishedLetters.php

July 22, 2005

Byron Calame
Public Editor
New York Times

Re: “Belated Charge Ignites Furor Over AIDS Drug Trial” (alternate title, “Reports on AIDS Tests on Foster Children Lead to Charges of Racism”), by Janny Scott and Leslie Kaufman Sunday, July 17, front page.
This article unfairly casts doubt on the motives and credibility of everyone who criticizes the morality of setting aside federal regulatory safeguards that restrict the enrollment of children in foster care – legal wards of the state or municipal government—in medical experiments. The article appears to be a slipshod effort to vindicate the New York City Administration of Children Services (ACS) and the medical institutions that approved the enrollment of foster children in experimental, phase I and II, AIDS drug and vaccine trials. Such trials are NOT designed to offer a potential direct benefit to the subjects who incur therein the highest level of risks. Federal regulations restrict the enrollment of foster children in any experiments involving greater than minimal risk to protect them from harm and exploitation (45 CFR 46.409).

When it is deemed necessary to include foster care children in research involving greater than minimal risk, Federal regulations require that the institutions who conduct such trials must provide each child with an independent advocate to “act in the best interests of the child..for the duration of the child’s participation in the research.” (45 CFR 46.409(b))

A complaint citing evidence of institutional failure to comply with federal research safeguards was filed by me on behalf of the ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) on March 10, 2003 with the Food and Drug Administration and the federal Office of Human Research Protections (OHRP) prompting investigations by both agencies. (See: http://www.ahrp.org/ahrpspeaks/HIVkids0304.php )

The complaint identified the regulatory restrictions, citing a series of Phase I and II drug and vaccine experiments in which foster children were subjected to risk, pain and discomfort. The facts that have been uncovered thus far – primarily by an Associated Press investigation – have validated our concerns and corroborated the information that we disseminated about the trials and the enrollment of foster care children.

The Associated Press reported that the experiments:

(1) “exposed a vulnerable population to the risks of medical research and drugs that were known to have serious side effects in adults and for which the safety for children was unknown.”

(2) “Several studies that enlisted foster children reported patients suffered side effects such as rashes, vomiting and sharp drops in infection-fighting blood cells as they tested antiretroviral drugs to suppress AIDS or other medicines to treat secondary infections.”

(3) “Some foster children died during studies, but state or city agencies said they could find no records that any deaths were directly caused by experimental treatments.”

(4)“In one study, researchers reported a “disturbing” higher death rate among children who took higher doses of a drug. That study was unable to determine a safe and effective dosage.”

(5) In the dapsone study, “overall mortality while receiving the study drug was significantly higher in the daily dapsone group. This finding remains unexplained.”

See: “Researchers Tested AIDS Drugs on Children” http://www.ahrp.org/infomail/05/05/04.php

AP’s investigative reporter, John Solomon, confronted ACS with his finding that 465 children in New York City’s foster care program had been enrolled in AIDS drug and vaccine tests – not 89, as ACS had maintained. Only then did ACS revise its claim, acknowledging that 465 children had been enrolled in the trials.

Solomon’s investigation further uncovered evidence that New York City “could find records showing 142 – less than one-third – of the 465 foster children in AIDS drug trials” received “independent advocates to monitor their well-being even though city policy required them.” Furthermore, Solomon found that these trials had been conducted in at least seven states – elevating the issue to one of national proportion.

A preliminary letter of findings by OHRP (May 23) further validated our concerns about the failure of the research centers involved to provide an independent advocate – as required under federal regulations. On June 16, AP reported:

“OHRP’s ruling is the first that federal research involving AIDS drugs and foster children violated federal protections. It was prompted by a complaint filed last year by the Alliance for Human Research Protection, an advocacy group in New York which raised concerns about a New York Post story documenting AIDS drug testing at a Catholic charity foster home in the city.”

“Columbia University Presbyterian Medical Center in New York, where several foster children were enrolled in drug studies in the 1990s, failed to obtain and evaluate whether it had proper consent, information and safeguards for the foster kids.” See: http://www.hhs.gov/ohrp/detrm_letrs/YR05/may05c.pdf

Scott and Kaufman failed to report the findings of Solomon’s investigative AP report or to cite it. Neither do they cite a single physician or ethicist who has criticized the experiments – as any balanced and fair news report should. The AP cited Arthur Caplan, Director of the Center for Bioethics, University of Pennsylvania, who said: “advocates should have been appointed for all foster children because researchers felt the pressure of a medical crisis and knew there was great uncertainty as to how children would react to AIDS medications that were often toxic for adults.”

“It is exactly that set of circumstances that made it absolutely mandatory to get those kids those advocates,” Caplan said. “It is inexcusable that they wouldn’t have an advocate for each one of those children.”

Instead, of examining the facts and the moral issues, Scott and Kaufman methodically attempted to discredit all of the various critics. The Times story served to lend the appearance of legitimacy to the self-serving claims made by those who broke the rules, who denied foster children the protection of an independent advocate. The ACS attorney who approved and was in charge of the project is quoted stating: “the agency had acted slowly and carefully, aware o the need to protect a particularly vulnerable population.”

The unsubstantiated claims of the physicians involved in the experiments are transcribed as if they were Gospel: “They say hundreds, perhaps thousands, of children benefited; many of those were children not in foster care..Because of what we did, we were able to keep them alive..” The Times article promotes the false claim that these foster children were receiving “lifesaving” treatments, when many were, in fact used to test experimental phase I and phase II drugs and vaccines. Contrary to the evidence uncovered by the AP, that children died in the experiments, the Times relied on hearsay: “Numerous doctors interviewed said they knew of no foster child who died as a result of the trials.”

A comparison between the solid journalism of the AP reports with the Scott / Kaufman article reveals shoddy, biased reporting by the latter.
See: AP report, May: http://www.ahrp.org/infomail/05/05/04.php and June: http://www.ahrp.org/infomail/05/06/16.php

It is particularly galling that the reporters, Scott and Kaufman, who approached me as a credible source of information and availed themselves of my expertise and guidance when they were assembling information about a subject with which they were entirely unfamiliar, should slant the report in an effort to discredit the information I provided – even as it has been borne out by independent investigations. They have attempted to marginalize me and to undermine my credibility for speaking truth to power.

Not only did I provide these reporters with information and contacts, but I literally had to instruct Janny Scott how to access and download documents from a government website (www.clinicaltrials.gov) containing the bare-bones information about the trials. Scott called numerous times to say she was unable to access the 36 trials that I had downloaded, suggesting that she come to my home to compare our disparate retrievals. She contacted me while I was traveling to help sort out how to proceed. When I alerted her about the OHRP letter of findings, she called to ask, “what does the letter mean?” Evidently, neither Scott nor Kaufman have had experience in deciphering linguistic soft-peddling by government agency bureaucrats when a powerful institution is found to have been non-compliant with regulations. Their NYT article refers to the OHRP letter as having been issued in June when it was, in fact, dated May 23.

This is an egregious example of journalists acting as public relations spokespersons in the attempt to deflect and whitewash transgressions by powerful institutions – government and academic. The article both failed to reveal the damaging evidence and to address the moral issues involved by casting aspersions on the handful of critics. For Scott to try to cast doubt on my credibility and to trivialize my professional services – which are used to assess and disseminate credible information about medical research abuses and conflicts of interest – is dishonest and a likely breach of journalism ethics. I am a law librarian by profession.

The following public policy questions were not addressed by the Times article:
1. Do local government agencies, medical centers, and physicians have the right to facilitate research by overriding federal safety requirements that were enacted for the protection of disadvantaged, vulnerable children who are wards of the state?

2. Are disadvantaged minority children in foster care entitled to the protections specified in federal regulations or are they fair game for enrollment in high risk drug trials whenever researchers are hard-pressed to fill a need for human subjects?

3. What prevented the institutions conducting the AIDS drug and vaccine trials from complying with federal regulations by appointing an independent advocate?

4. Did the interest of the research collide with the best interests of the children?

If these reporters are up to doing careful homework, they will find clues to answer these questions as set forth by the principles of the Nuremburg Code (www.cirp.org/library/ethics/nuremberg )

and the Declaration of Helsinki of the World Medical Association (www.cirp.org/library/ethics/helsinki ).

One would hope and pray that the moral values of NYT reporters and editors place a priority on protecting vulnerable children from those in positions of power and influence who would take liberties with their best interests.

If the Times cannot be relied upon to present a fair report relating to legitimate criticism about the conduct of medical research which put vulnerable, non-consenting human beings at high risk of injury or death, it will certainly lead the largely African-American population whose children were affected to conclude that the Times reflects an elitist culture.

The grossly inadequate, biased report about a case that is reverberating on both sides of the Atlantic requires immediate correction. The issues addressed require reporting that is wise and sensitive to a people whose often devalued existence has historically led to their use as guinea pigs in risky medical experiments going back at least to the infamous Tuskegee syphilis experiment and continuing to this day to EPA sanctioned lead-poisoning and pesticide experiments. Should not the Times seek accountability for public decisions that affect the life safety of vulnerable minority children?

Vera Hassner Sharav
President
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
New York City

Read the rest at: http://www.ahrp.org/children/NYTimes0705/UnpublishedLetters.php

Liam @ 08/12/05 19:31:58

Read the rest at: http://www.ahrp.org/children/NYTimes0705/UnpublishedLetters.php

cc: Victor Navasky and Michael Hoyt, Columbia Journalism Review Ann Pincus, Center for Public Integrity: Investigative Journalism in the Public Interest

~~~~~~~~~~~~~~~~~

2. David Crowe, President of Alberta Reappraising AIDS Society
Date: Mon, 18 Jul 2005
To: letters@nytimes
From: David Crowe
Subject: Letter to the editor…

Cc: janscott@nytimes, leslie@nytimes

Dear editors;

Please consider the following letter for publication in response to:

Scott J et al. Reports on AIDS drug tests on foster children lead to charges of racism. NY Times. 2005 Jul 17.

Regards,

David Crowe
President
Alberta Reappraising AIDS Society
Calgary, Alberta, Canada

Your July 17th article “Reports on AIDS drug tests on foster children lead to charges of racism” is essentially propaganda defending mainstream treatment of HIV/AIDS as the only option. Orphans should be grateful, it implies, that they are able to receive the experimental drugs normally reserved for the rich.

One of the serious problems with the article is its discussion of AZT (azidothymidine, also known as Retrovir, Zidovudine or ZDV). This drug is designed to substitute for one of the four building blocks of DNA (Thymidine) and was originally designed as a cancer drug because of its ability to interfere with cell division. Knowing this, it should not be surprising that some journalists, activists and scientists are sounding the alarm over its use by pregnant women and infants.

While doctors like Stephen Nicholas might laud clinical trial ACTG 076 [1] because it showed that children of HIV-positive mothers taking AZT were less likely to become HIV-positive, the trial also showed a significantly higher level of anemia in exposed infants. This is not surprising, as serious anemia is one of AZT’s most common side effects. Later studies of HIV transmission rates with AZT have been all over the map but accepting that the reduction of transmission from 25% without AZT to 8% with AZT is real, only 17% of infants will receive any benefit from AZT, but 100% will suffer the consequences of exposure to the drug.

The results of ACTG 076 provides little evidence that AZT will result in better health in exposed children. In fact, other studies indicate that fetal exposure to AZT results in the birth of children who are sicker and more likely to die. These include an Italian study that reported “Comparison of HIV-1-infected children whose mothers were treated with ZDV [AZT] with children whose mothers were not treated showed that the former group had a [1.8 times] higher probability of developing severe disease or severe immune suppression [2.4 times higher risk] and a lower survival (72.2% versus 81.0%).” [2]

A Brazilian study noted “The rate of RPD [rapid disease progression] was significantly higher among perinatally infected infants born to HIV-infected mothers treated with ZDV than among infected infants born to untreated mothers”. [3]

French researchers reported on rare and serious mitochondrial disorders in children fetally exposed to AZT (mitochondria are the essential energy-regulating organelles in most living cells with their their own DNA, making them vulnerable to AZT) [4]. Another study found that all but one child with mitochondrial dysfunction had been exposed to AZT and other antiretroviral drugs in the womb, during delivery and as an infant [5].

An American study, including mothers from New York City, found that “Zdv [AZT] exposure was associated with a 1.8-fold increased risk of progressing to AIDS or death after adjusting for year of birth, maternal CD4 cell count, maternal AIDS diagnosis, and subsequent antiretroviral therapy of the child.” [6]

Another American trial noted that “Children of study women who were prescribed ZDV [AZT] had increased adjusted odds of any anomaly (adjusted odds ratio [OR], 1.55) [i.e. more than one-and-one-half times the risk of a birth anomaly than the HIV+ population being studied in general]...the risk of a major anomaly in the study cohort was 2.79 times greater than the general population” [7]

Yet another concluded that “Other factors associated with lower cumulative survival included suppressed CD4 cell counts, a history of zidovudine [AZT] therapy…” [8]

Another study including New York City children found that “FTT [failure to thrive among children of HIV-positive women] was associated with a history of pneumonia, maternal use of cocaine, crack or heroin during pregnancy, infant CD4+ T-cell count and any antiretroviral therapy by 3 months of age…ZDV [AZT], in particular, alters mitochondrial metabolism and may have direct nutritional effects.” [9]

Doctors, who may be considered reliable sources for articles like this, actually have a serious bias in favor of drug therapy. For example, a study of the use of AZT in preemies claimed that “Zidovudine was generally well tolerated in this high-risk population” but also noted that “Slightly more than half of the subjects had anemia severe enough to require a transfusion.” [10]

A much more complete list of quotes from scientific papers and other sources on the danger and ineffectiveness of AZT is at http://aras.ab.ca/azt.html. I encourage New Yorkers to educate themselves on the drugs being used at the Incarnation Children’s Center and elsewhere. The information is out there, and not all of it is provided by organizations with financial incentives to put rose-colored filters between the raw (and sometimes ugly) data and its vieweres.

REFERENCES

[1] Connor EM et al. Reduction of Maternal-Infant Transmission of Human Immunodeficiency Virus Type 1 with Zidovudine Treatment. N Engl J Med. 1994 Nov 3; 331(18): 1173-1180.

[2] The Italian Register for HIV Infection in Children. Rapid disease progression in HIV-1 perinatally infected children born to mothers receiving zidovudine monotherapy during pregnancy. AIDS. 1999 May 28; 13: 927-33.

[3] de Souza RS et al. Effect of prenatal zidovudine on disease progression in perinatally HIV-1-infected infants. J Acquir Immune Defic Syndr. 2000 Jun 1; 24(2): 154-161.

[4] Blanche S et al. Persistent mitochondrial dysfunction and perinatal exposure to antiretroviral nucleoside analogues. Lancet. 1999 Sep 25; 354: 1084-9.

[5] Barret B et al. Persistent mitochondrial dysfunction in HIV-1-exposed but uninfected infants: clinical screening in a large prospective cohort. AIDS. 2003 Aug 15; 17(12): 1769-1785.

[6] Kuhn L et al. Disease Progression and Early Viral Dynamics in Human Immunodeficiency Virus Infected Children Exposed to Zidovudine during Prenatal and Perinatal Periods. J Infect Dis. 2000 Jul; 182(1): 104-11.

[7] Newschaffer CJ et al. Prenatal Zidovudine Use and Congenital Anomalies in a Medicaid Population. J Acquir Immune Defic Syndr. 2000 Jul 1; 24(3): 249-256.

[8] Lipshultz SE et al. Cardiac Dysfunction and Mortality in HIV-Infected Children. Circulation. 2000 Sep 26; 102(13): 1542-8.

[9] Miller TL et al. Maternal and infant factors associated with failure to thrive in children with vertically transmitted Human Immunodeficiency Virus-1 infection: the prospective, P2C2 Human Immunodeficiency Virus Multicenter study. Pediatrics. 2001 Dec; 108(6): 1287-96.

[10] Capparelli E et al. Pharmacokinetics and tolerance of zidovudine in preterm infants. J Pediatr. 2003 Jan; 142(1): 47-52.

~~~~~~~~~~~~~

Liam @ 08/12/05 19:34:24

Read the rest at: http://www.ahrp.org/children/NYTimes0705/UnpublishedLetters.php

3. EDWARD M. OPTON, JR.
1428 Cornell Avenue, Berkeley, CA 94702

1 August 2005

Mr. Byron Calame
Public Editor
The New York Times
229 West 43rd Street
New York, NY 10036

Re: “Belated Charge Ignites Furor Over AIDS Drug Trial” (7/17/05)

Dear Mr. Calame:

I am writing to call your attention to serious errors in the July 17 story, “Belated Charge Ignites Furor Over AIDS Drug Trial” (apparently also titled “Reports on AIDS Drug Tests on Foster Children Lead to Charges of Racism”) by J. Scott and L. Kaufman. The errors are all in a single direction, so it is not plausible that they are merely the inevitable inaccuracies that creep into daily journalism. The errors appear to be designed to advance an argument. The argument is: that recent criticism of the use of foster children in HIV/AIDS research at Incarnation Children’s Center is merely griping by a handful of cranks who have agendas unrelated to the protection of foster children. The agendas, as implied in the story, are, in the case of Liam Scheff, denial that the HIV virus causes AIDS, and, in the case of Omowale Clay and the December 12th Movement, a determination to agitate over racial issues. Mr. Liam and Mr. Clay, the story implies, have duped others, including the AP and the BBC, leading to the current investigations of Incarnation Children’s Center (“ICC”).

I know little about Mr. Scheff or Mr. Clay, but I am familiar with ICC’s main critic, the Alliance for Human Research Protection (“AHRP”) and its primary spokesperson, Vera Hassner Sharav. AHRP and Ms. Sharav have done their own research, as have the Associated Press and the federal Office of Human Research Protections (“OHRP”), which recently confirmed the main AHRP charges and demanded that Columbia University and New York Presbyterian Hospital, the research institutions affiliated with ICC, address their failures to comply with federal regulations. Ms. Sharav, AHRP, the AP, the BBC, and the OHRP have not been led by the nose into unwarranted agitation against the ICC, Columbia or New York Presbyterian Hospital.

A few hour’s research on the Internet has convinced me that the argument of the Times story is mistaken and that vital “facts” cited to support the argument of the story are not facts and would readily have been ascertained to be non-facts by fair-minded reporters.

For example:

The Times wrote: “Ms. Sharav forwarded Mr. Scheff’s article to the 3,500 people she said receive her e-mail ‘infomails’ daily. She then looked into Incarnation on the Internet.”

The implication is that Ms. Sharav, either na†ve or malicious, (a) disseminated an inflammatory screed by Mr. Scheff, the alarmist who denies that HIV causes AIDS, and (b) only then did she begin to look into the matter. If these “facts” were true, they would discredit Ms. Sharav and the AHRP and trivialize AHRP’s complaint against ICC.

Both (a) and (b) are false. (1) I am on the AHRP infomail list. I don’t recall ever hearing of Mr. Scheff until I saw his name in the Times article on July 17. (2) Not trusting my memory, I checked the AHRP Website, www.ahrp.org, which archives Ms. Sharav’s infomails. The website includes a full text search function. A search finds only two mentions of Mr. Scheff, neither of them by Ms. Sharav. They are contained in newspaper stories appended to two infomails in April 2005. (3) I checked with Ms. Sharav. She confirmed that she has never circulated Mr. Scheff’s writings, though she is well aware of his existence. AHRP complained to the federal Office for Human Research Protections only after Ms. Sharav conducted two months of research on the use of foster children at ICC in clinical trials.

AHRP filed its complaint with the Office for Human Research Protections and the Food and Drug Administration on March 10, 2004, as noted and documented in Ms. Sharav’s recent letter to you (See: http://www.ahrp.org/ahrpspeaks/HIVkids0304.php.) AHRP was aware of Mr. Scheff’s serious allegations, as he had published them in the New York Press in January 2004. (See http://nypress.com/print/cfm?content_id=101614.) But AHRP, after doing its independent investigation in January and February 2004, chose not to republish Mr. Scheff’s allegations. AHRP’s complaint focused on the ethical and legal implications of experimentation on foster children.

2. “They [unnamed “physicians and federal health officials”] say they obtained legal permission for the children’s participation, either from the biological parents or child welfare officials, in all but a small number of cases.”

The Times story does not name the physicians or officials, so one cannot determine independently what they said. But in the above quote the Times presents a response to the AHRP complaint that in no way addresses the complaint. In other words, the Times implies that AHRP complained that the ICC had experimented on foster children without permission, and that “they,” the unnamed physicians and officials, refuted the complaint, saying they had obtained permission, either from biological parents or from child welfare officials. The controversy is reduced to a “she said-they said” squabble: Ms. Sharav versus unnamed physicians and officials.

The error here is that the major theme of the AHRP complaint is not that New York’s child welfare officials did not approve experiments on their wards. The AHRP complaint is that child welfare officials DO NOT HAVE THE LEGAL AUTHORITY to consent to experiments such as those conducted at the ICC on foster children. The AHRP complaint alleges that the applicable federal regulations, such as 45 CFR 46.409, require an advocate for each individual foster child, not just the blanket sign-off by a city government agency that ICC and the researchers obtained. See , e.g., the federal Office for Human Research Protections letter to Dr. Harvey Colten and Dr. Laura Forese, which responded to AHRP’s complaint, sustained most of it, and withheld judgment on the crucial issue discussed here: whether the federal regulations required individual advocates for the foster children used in the ICC clinical trials. The OHRP letter was dated May 23, 2005, so it was available to your reporters.

In other words, the AHRP complaint alleges that the child welfare officials lacked legal authority to authorize experimentation on ICC’s foster children. The unnamed physicians and federal health officials responded that they obtained permission from child welfare officials. In politics, this is called a non-denial denial. If AHRP’s legal analysis is correct – an issue that OHRP has not yet decided – the physicians and federal health officials concede that the complaint is well founded. This is just the opposite of the implication of the Times story.

3. “A federal agency is investigating whether guidelines for including foster children in trials were violated.” This statement in the story’s third paragraph is a classic instance of disinformation by “spin.” The major outcome of the federal agency’s investigation is buried in the tenth paragraph: “the Office of Human Research Protections [OHRP], found in June [sic—actually May 23, 2005] that one New York hospital had approved four of the trials without gathering enough information . . . or [information] about the process for getting their parents’ or guardians’ permission.” And in the ninth paragraph: “‘We don’t believe we have all the permissions by any means,’ said Sharman Stein, director of communications . . . .” These major “failures” (the term OHRP used repeatedly in its May 23 letter to Columbia and to New York Presbyterian Hospital) are buried deep in the Times story, while the one item that the OHRP is still investigating is featured in the third paragraph.

4. The Times’s most serious unfairness to AHRP and Ms. Sharav is that it encourages readers to lump them with fringe elements—Mr. Scheff, who does not believe that HIV causes AIDS, and Mr. Clay of the December 12th Movement. The Times story ignores the substance of AHRP’s concern, which was very much available to the Times reporters: the concern that conflict of interest in medical research will lead to serious harm, as it has in the past (e.g., Tuskeegee (syphilis), Willowbrook (hepatitis)), as it may have done at Incarnation Children’s Center, and as it will in the future. (See, for example, http://www.micahbooks.com/readingroom/humanexperimentation.html; http://www.marcussternum.tripod.com/human.htm; http://serendip.brynmawr.edu/biiology/b103./101/web2/kiefer.html, especially the references cited there.)

The conflict of interest at Incarnation Children’s Center occurred because the New York City Agency for Children’s Services granted permission, carte blanche, for its foster children wards to be used as the subjects of medical experiments, entrusting the balancing of possible benefits and risks to the same researchers whose careers and budgets depended on a plentiful supply of subjects. Whether that abdication of responsibility (and violation of federal regulations) resulted in harm in this particular case is the subject of continuing controversy, a controversy complicated by the fact that Children’s Services maintained, until recently, that only 60 of its residents had been experimented on, then it admitted to 89, and most recently, in March 2005, it acknowledged that the true number was at least 465. Are the unidentified physicians’ conclusions that no one was harmed subject to revision on the same scale? But I digress. The Times story implies the same “logic” I heard so often when I lived in North Carolina in the ’60s: “Communists demand desegregation. These picketers and sit-inners [my friends and myself] demand desegregation. Therefore [sometimes voiced, sometimes implied] they are nothing but a bunch of Communist dupes.” The Times story’s attempt to paint Incarnation’s most serious critics as dupes of the dubiously credible is unworthy of your newspaper.

In my profession—I am a corporate lawyer specializing in labor and employment law—I have often been called on to review the work of my clients’ PR staffs. As a professional wordsmith-for-hire myself, I cannot but admire the well-crafted hit job. Best of all, from the client’s perspective, are the occasions when the client manages to put its spin under the bylines of insufficiently wary reporters. Flackery from an ostensibly neutral source is by far the most effective kind. It appears that that has happened here.

By way of full disclosure: I have been a student of research ethics issues ever since I co-authored a book, partly on that subject, with a law professor in 1978. I am on the AHRP “infomail” (e-mail) list, and I have met Ms. Sharav on two occasions. From 1974 through 2004 I was a member of an institutional review board, the State of California Health and Human Services Agency Committee for the Protection of Human Subjects, and in that capacity I have reviewed, and approved, hundreds of HIV/AIDS research proposals.

Yours sincerely,

Edward M. Opton, Jr., Ph.D., J.D.

~~~~~~~~~~~~~~~~~~~~~~~~

Liam @ 08/12/05 19:39:04

Read the rest at: http://www.ahrp.org/children/NYTimes0705/UnpublishedLetters.php

4. From The Wilderness
http://www.fromthewilderness.com/cgi-bin/MasterPFP.cgi?doc=http://64.239.13.64/free/ww3/071905_Liam_scheff.shtml

*WARNING: CONTAINS GRAPHIC IMAGES

[FTW can’t cover everything. But when we get wind of an especially egregious bit of journalistic villainy, we like to smack the bully in his smug face. Here, a brave investigative reporter named Liam Scheff went undercover in a clinic that houses orphans; he discovered extensive medical abuse and an embittering disregard for the wellbeing of the kids – including force-feeding of drugs whose toxic side effects were already acknowledged by the manufacturers. Anybody who knows the stories of authoritarian medicine from Tuskegee to Auschwitz will recognize the smell of moral death here. What you’re smelling is the perilous mixture of bureaucracy, technology, and racism that marks the nadir of human activity – it is the worst we can do.

If that sounds harsh, read Scheff’s original report, “The House That AIDS Built.”

But the Paper of Record prefers to swat the gadfly:

Whatever the outcome, the controversy has already demonstrated the power of a single person armed only with access to the Internet and an incendiary story to put major institutions on the defensive. The story taps a combustible mix of fears: the suspicions of some activists that AIDS is not necessarily caused by H.I.V. and that AIDS drugs do not necessarily help, and the belief of some black people that the medical establishment does not always have their interests at heart.

That will not do. AIDS activists do not merely “suspect,” and Black people do not merely “believe,” that there is something wrong with the “major institutions” of corporate pharmacology in the United States. Bona fide researchers and investigators like Christine Maggiore can be heard explaining this all the time. But these two NYT writers can’t hear it – maybe the roar of the gravy train is too loud. – FTW]

Another Attack on Authentic Investigative Journalism
An Open Letter to the New York Times in Defense of Liam Scheff
by
Michael Kane, Jamey Hecht, and Michael C. Ruppert

janscott@nytimes, leslie@nytimes, letters@nytimes

In the July 17, 2005, piece titled “Belated Charges Ignite Furor Over AIDS Drug Trial,” by Janny Scott and Leslie Kaufman, the New York Times seemingly accuses journalist Liam Scheff of having fabricated the findings of his report regarding the forced drugging of Black and Latino children at the Incarnation Children’s Center (ICC). Despite their multiple known and admitted toxicities, these drugs were administered through tubes surgically inserted in the children’s stomachs.

Your claim that there is no “official evidence” presented in Mr. Scheff’s reports is simply false.

First, Mr. Scheff shows that the drugs being given to these children have extremely toxic side effects, which are listed by the manufacturer on the packaging. For example, Nevirapine (Viramune), manufactured by Boeringer-Ingelheim, lists the following warnings:

“Patients should be informed of: the possibility of severe liver disease or skin reactions associated with Viramune that may result in death.”

“Severe, life-threatening and in some cases fatal hepatotoxicity [liver damage], including hepatic necrosis [liver death] and hepatic failure, has been reported in patients treated with Viramune.”

“Severe, life-threatening skin reactions, including fatal cases have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis [skin death]”

Nevirapine is a drug given to pregnant African women who test HIV positive. And here’s what toxic epidermal necrolysis actually looks like:


A baby with Steven-Johnsons Syndrome. SJS can be caused by Nevirapine.


Steven-Johnsons Syndrome or Toxic Epidermal Necrolysis related to Nevirapine.

Two related European studies on Nevirapine toxicity:
http://www.altheal.org/pdf/nevirapine1.pdf
http://www.altheal.org/pdf/nevirapine2.pdf

In fact, all of the drugs given at ICC have known toxicities which the manufacturers themselves admit. This is most certainly true for AZT, whose side effects are amply documented in the medical literature: they include liver swelling, severe anemia, muscle wasting, fat degeneration, and blood toxicity, all of which appear on the manufacturer’s label.

Mr. Scheff interviewed ICC’s medical director, Dr. Katherine Painter, where she stated that inserting a surgical tube into a child’s abdomen to force them to take drugs is done “when other interventions to help a child take a medicine by mouth have failed.”

So when the children don’t want to take drugs with known toxicities, a surgical tube forces them to ingest them against their will.

The Times states that Mr. Scheff “claims” children are being “force-fed” drugs. This is not a mere claim by Mr. Scheff; it is confirmed by the medical director of ICC. Tube-feeding drugs directly into the stomach is certainly a form of “force feeding,” especially if there is no parental consent.

In some cases, children were forced to stay at ICC if their guardian refused to administer the drugs. Such a guardian is deemed a “negligent parent.” This is the case with Mona Newberg who is no longer the legal guardian of her niece’s daughter Dana. At the time Mr. Scheff wrote the article, 16 year old Dana was removed from her aunt’s home into ICC. Her brother Sean had been remanded to ICC for refusing to take medications. Sean was interviewed in the BBC film “Guinea Pig Kids” in which he talked about his desire to quit the medication regimen:

http://news.bbc.co.uk/1/hi/programmes/this_world/4035345.stm

Mr. Scheff also interviewed Nurse Jacklyn Herger, who had worked at ICC throughout the 90’s. She adopted two HIV positive children from ICC and confirmed to Mr. Scheff that it wasn’t until she took the two children off the drugs that their health started to improve. Herger concluded that the drugs “not only weren’t helping the girls, they were making them ill.”

She also confirmed that ICC had been conducting clinical trials since the early 1990’s. ICC is always conducting multiple clinical trials, as was confirmed by Dr. Katherine Painter in an interview with Mr. Scheff.

Thanks to Mr. Scheff’s report, the Department of Health and Human Services Office of Human Research Protections investigating the clinical trials on Black and Hispanic orphans at ICC has found that the National Institutes of Health (NIH) and Columbia Presbyterian Hospital acted unethically.

In the Times article, you write:

All this is happening despite the fact that there is little evidence that the trials were anything but a medical success.
Oh really?

Where is the evidence that the trials were a success? The Times states:

By 2000, the number of children under 20 who died of AIDS in the city that year dropped to 13 from more than 100 per year less than a decade before.
However, the following is also admitted in your article:

In March, the child welfare agency handed its critics new ammunition. It revised its count of the number of children in the trials, to 465 from 89, saying it had discovered an additional box of documents in the basement.
If there were nearly 400 children at ICC who were ‘unknown’ because their documentation was “in the basement,” can it honestly be said that we know how many of them died in 2000 when the overwhelming majority didn’t even have an accessible file? Many of these children were orphans. If they died, few people outside of ICC would be likely to learn of it.

Would it be in ICC’s interest to cover up such deaths?

Still, you feel very safe in stating that, “many (at ICC) said they remembered no fatal reactions.” But a source told Mr. Scheff that two children at ICC did in fact die while Scheff was investigating the Center. He shared that source’s name with you so that the Times could follow up with due diligence, but that does not seem to have happened. Why no mention of this? To repeat: you were given the contact information for the source of Mr. Scheff’s claim regarding the two deaths. Did you attempt to contact that source?

Perhaps the Department of Health and Human Services Office of Human Research Protections will be able to conduct a proper investigation and determine once and for all who is telling the truth here and who has a hidden agenda.

It seems the position of the Times is that Black and Latino children were indeed forced to take drugs with known toxicities against their will, but that this was done for their own good.

In closing, one of the biggest bombshells put forth by Mr. Scheff comes from ICC’s own published history:

“Early in the [AIDS] epidemic, HIV disease of childhood was considered to be a downhill course leading to death. But in the late 1980’s, before AZT was available, many very ill children admitted to ICC got dramatically better with proper nurturing and high quality medical and nursing care.”
If ICC has documented this, then why in God’s name are they now forcing toxic drugs into the stomachs of Black and Latino children in Washington Heights, NY? Cui Bono?

Thank you for your time.

Sincerely,

Michael Kane
Jamey Hecht
Michael C. Ruppert

From The Wilderness Publications

~~~~~~~~~~~~~

Liam @ 08/12/05 19:39:58

6. Edward M. Opton, Jr., Ph.D., J.D.
——-Original Message——-

From: eopton@comcast
Sent: Thursday, August 04, 2005 8:10 PM
To: janscott@nytimes; leslie@nytimes; letters@nytimes
Subject: NYT Story re Incarnation Children’s Center and HIV/AIDS Clinical Trials

8/4/05

This letter supplements my earlier letter concerning the Times’s story on HIV/AIDS clinical trials at Incarnation Children’s Center.

I learned today of the letter to you on the same subject by Michael Kane, Jamey Hecht, and Michael C. Ruppert. I don’t know enough medicine to agree or disagree with their skepticism about the link between HIV and AIDS, though I know it is a position held by a small minority.

That point aside, I do know, because I have read the documents they cite, that the facts stated in the remainder of their letter are correct. Mr. Scheff did cite official documents concerning the anticipated adverse effects and well known toxicity of several drugs used to treat HIV infection. Mr. Scheff did write that he interviewed Incarnation’s medical director, Dr. Painter, and I haven’t seen any denial that he quoted or paraphrased her statements incorrectly. The same is true for Ms. Herger. I don’t recall whether Mr. Scheff cited these witnesses by name in his initial article, but I know that he did cite them by name in his subsequent ariticles, documents that were available to your reporters.

Finally, I want to add an important point to those made by Mr. Kane, Ms. Hecht and Mr. Ruppert. The Times story offers the following statement as evidence that the clinical trials at Incaration saved lives:

“By 2000, the number of children under 20 who died of AIDS in the city that year dropped to 13 from more than 100 per year less than a decade before.”

The quoted sentence in no way supports the conclusion that the clincial trials were effective in improving treatment of infants and children with HIV/AIDS. Documents (“offical” documents, not polemics) that I quickly found in Internet research on “Incarnation Children’s Center” and a few related keywords report that hundreds of HIV-infected babies were born each year in New York City in the early 1990’s. Vigorous efforts were made to reduce the number. Those efforts, directed to parents, not children, were spectacularly successful. In some recent years, the number of HIV-infected babies born in New York City has been reduced to single digits! That is a very important story, and it is one that, if it hasn’t been reported, should be.

The collapse in the incidence of HIV-infected newborns means that the population of children at risk for AIDS mortality in 2000, and today, is a small fraction of the number at risk in the early 1990s.

In short, in the early 1990’s hundreds of children were being born each year with HIV infection, and hundreds were dying at very early ages. I believe the figures were approximately 25% dead before age two and 50% by age four. By 2000, only a handful of HIV-infected babies were being born each year, so the population of infants and children at risk consisted of that handful plus the children, now much older, who had survived the high mortality of the early 1990s.

If Incarnation Children’s Center’s public relations people told your reporters that the decrease in AIDS mortality numbers was evidence of the clinical trials’ benefits, the PR people were providing a great deal less then the whole truth. The meaningful comparison is the percentage of infants and children in each age group dying in the earlier years and the later years. It is discouraging that the Times’s reporters did not focus on that. Surely they were aware that institutions accused of unethical conduct sometimes defend themselves with misleading statistics .

In any event, issues of institutional ethics, medical ethics and regulatory compliance are not decided by looking back at the results of treatment. It would be wrong for me to write a bad check regardless of whether the bank cashes it or not. If the federal regulations prohibited the experimentation on foster children at Incarnation Chidlren’s Center, the experiments violated the regulations regardless of the outcome.

The fundamental wrong in the Incarnation Children’s Center clinical trials was that all decisionmakers—the researchers, the Children’s Center administrators, the City’s child welfare bureaucrats, and the university hospitals—had serious conflicts of interest. The clinical trials were definitely good for them, for their careers and for their budgets. They were not in a position to make unbiased decisions as to whether possible benefits outweighed the risks of the clincial trials. That is why the federal regulations require advocates for foster children. And that is the important fact that the Times’s story suppressed.

Yours sincerely,

Edward M. Opton, Jr., Ph.D., J.D.

~~~~~~~~~~~~~~~~~~~~~~

Liam @ 08/12/05 19:40:55

6. Edward M. Opton, Jr., Ph.D., J.D.
——-Original Message——-

From: eopton@comcast
Sent: Thursday, August 04, 2005 8:10 PM
To: janscott@nytimes; leslie@nytimes; letters@nytimes
Subject: NYT Story re Incarnation Children’s Center and HIV/AIDS Clinical Trials

8/4/05

This letter supplements my earlier letter concerning the Times’s story on HIV/AIDS clinical trials at Incarnation Children’s Center.

I learned today of the letter to you on the same subject by Michael Kane, Jamey Hecht, and Michael C. Ruppert. I don’t know enough medicine to agree or disagree with their skepticism about the link between HIV and AIDS, though I know it is a position held by a small minority.

That point aside, I do know, because I have read the documents they cite, that the facts stated in the remainder of their letter are correct. Mr. Scheff did cite official documents concerning the anticipated adverse effects and well known toxicity of several drugs used to treat HIV infection. Mr. Scheff did write that he interviewed Incarnation’s medical director, Dr. Painter, and I haven’t seen any denial that he quoted or paraphrased her statements incorrectly. The same is true for Ms. Herger. I don’t recall whether Mr. Scheff cited these witnesses by name in his initial article, but I know that he did cite them by name in his subsequent ariticles, documents that were available to your reporters.

Finally, I want to add an important point to those made by Mr. Kane, Ms. Hecht and Mr. Ruppert. The Times story offers the following statement as evidence that the clinical trials at Incaration saved lives:

“By 2000, the number of children under 20 who died of AIDS in the city that year dropped to 13 from more than 100 per year less than a decade before.”

The quoted sentence in no way supports the conclusion that the clincial trials were effective in improving treatment of infants and children with HIV/AIDS. Documents (“offical” documents, not polemics) that I quickly found in Internet research on “Incarnation Children’s Center” and a few related keywords report that hundreds of HIV-infected babies were born each year in New York City in the early 1990’s. Vigorous efforts were made to reduce the number. Those efforts, directed to parents, not children, were spectacularly successful. In some recent years, the number of HIV-infected babies born in New York City has been reduced to single digits! That is a very important story, and it is one that, if it hasn’t been reported, should be.

The collapse in the incidence of HIV-infected newborns means that the population of children at risk for AIDS mortality in 2000, and today, is a small fraction of the number at risk in the early 1990s.

In short, in the early 1990’s hundreds of children were being born each year with HIV infection, and hundreds were dying at very early ages. I believe the figures were approximately 25% dead before age two and 50% by age four. By 2000, only a handful of HIV-infected babies were being born each year, so the population of infants and children at risk consisted of that handful plus the children, now much older, who had survived the high mortality of the early 1990s.

If Incarnation Children’s Center’s public relations people told your reporters that the decrease in AIDS mortality numbers was evidence of the clinical trials’ benefits, the PR people were providing a great deal less then the whole truth. The meaningful comparison is the percentage of infants and children in each age group dying in the earlier years and the later years. It is discouraging that the Times’s reporters did not focus on that. Surely they were aware that institutions accused of unethical conduct sometimes defend themselves with misleading statistics .

In any event, issues of institutional ethics, medical ethics and regulatory compliance are not decided by looking back at the results of treatment. It would be wrong for me to write a bad check regardless of whether the bank cashes it or not. If the federal regulations prohibited the experimentation on foster children at Incarnation Chidlren’s Center, the experiments violated the regulations regardless of the outcome.

The fundamental wrong in the Incarnation Children’s Center clinical trials was that all decisionmakers—the researchers, the Children’s Center administrators, the City’s child welfare bureaucrats, and the university hospitals—had serious conflicts of interest. The clinical trials were definitely good for them, for their careers and for their budgets. They were not in a position to make unbiased decisions as to whether possible benefits outweighed the risks of the clincial trials. That is why the federal regulations require advocates for foster children. And that is the important fact that the Times’s story suppressed.

Yours sincerely,

Edward M. Opton, Jr., Ph.D., J.D.

~~~~~~~~~~~~~~~~~~~~~~

Liam @ 08/12/05 19:40:57

Read the rest at: http://www.ahrp.org/children/NYTimes0705/UnpublishedLetters.php

7. Nathaniel S. Lehrman, M.D.
Sent: Monday, July 25, 2005 10:12 PM
To: public@nytimes; Vera Sharav; editor@cjr

Subject: More questions about July 17 story, “Furor Over AIDS Drug Trial”

To: Byron Calame, Public Editor, NYTimes

From the first word in its headline – “Belated” – the New York Times’ July 17 front page story, “Belated Charge Ignites Furor Over AIDS Drug Trial,” fell far short of journalistic standards of accuracy, completeness and objectivity. An important overall effect is subtly to discredit the motives and activities of the Alliance for Human Research Protection, and its president, Mrs. Vera Hassner Sharav, who have for several years, and with increasing success, been exposing serious ethical problems in the research on, and marketing of, many prescription drugs. Let me state here immediately and proudly that Mrs. Sharav is the co-author with me of “Ethical Problems in Psychiatric Research” (Journal of Mental Health Administration, 24 (2), 219 – 242, spring, 1997).

1. The word “belated” implies that an old, laid-to-rest issue is now being unnecessarily resurrected. The Times has, however, never properly addressed the morality of these AIDS drug tests on children, and the recent “discovery” that the trials involved 465 children, rather than 89 as originally claimed, is indeed news. Even though the outing of Valerie Plame Wilson is also hardly today’s news the Times’ very different attitude toward this “belated” news is worth noting.

2. The story is inaccurate in failing to make clear that the child-subjects were subjects of phase I and II trials, which merely determine possible toxicity and dosage levels, without offering any potential direct benefit to these subjects – a benefit which the law requires.

3. The story is grossly incomplete by omitting any mention of Associated Press reporter John Solomon’s detailed investigation of this case, which raised many of the questions about how the drug trials on these youngsters were carried out. All credit for raising these questions is instead given sneeringly to Liam Scheff, a self-described very independent journalist from the “go out and get the story, don’t let the slammed door get in your way school of journalism.” Mr. Scheff’s credibility – and therefore that of those he works with – is then further undermined by an irrelevant statement about his long time interest in what he calls ‘the other side of AIDS.’ Those questioning the dubious drug trials are thus implicitly tarred as loony.

4. The story falls far short of objectivity by failing to cite any physician or ethicist critical of the experiments – as a fair and balanced report should do. The AP story, for example, cited strong criticisms of the studies by Prof. Arthur Caplan, Director of the University of Pennsylvania’s Center for Bioethics.

Not only does the Times owe Mrs. Sharav, Mr. Scheff and AHRP an apology, but it should now present an unbiased story about their truly heroic work concernng the serious ethical problems with many drugs.

Nathaniel S. Lehrman, M.D.,
former Clinical Director, Kingsboro Psychiatric Center, Brooklyn NY;
former Assistant Clinical Professor of Psychiatry, Albert Einstein and SUNY Downstate Colleges of Medicine
Roslyn NY

Liam @ 08/12/05 19:44:20

Letter received Sunday Aug 4, 2005:

I just read your webpage and then I read the other where they are stating how great Incarnation is, both of these webpages are linked to each other, I am confused?

My sent response:

Hi Karen,

well, it’s confusing, isn’t it?

It is to me too. I’ve been investigating this situation for two years – it’s nice of the NYTimes to come to the rescue of the NIH....but it doesn’t mean it’s great for kids.

I’ll leave you with some reading. You can dig into it, if you want, at your leisure.

Here are some of my pieces on ICC:

Inside Incarnation – NY Press July 2005
http://www.nypress.com/18/30/news&columns/liamscheff.cfm

Orphans On Trial – NY Press:
http://nypress.com/print.cfm?content_id=10614

The same article with additional material, including some graphic photos from a bad drug trial:
http://www.altheal.org/toxicity/orphans.htm

Recent article – The House that AIDS Built
http://www.altheal.org/texts/house.htm

Here’s the BBC film:

BBC
http://news.bbc.co.uk/1/hi/programmes/this_world/4038375.stm

http://news.bbc.co.uk/go/pr/fr/-/1/hi/programmes/this_world/4035345.stm

Transcript:
http://news.bbc.co.uk/1/shared/spl/hi/programmes/this_world/transcripts/this_world_guinea_pig_kids.txt

and here’s my blog, where you can follow the week to week:

http://liam.gnn.tv

And here’s why I get into trouble:

http://www.gnn.tv/articles/article.php?id=1035

Why? I think it’s because I bother to report what I’m not supposed to report (b/c I think people have a right to know what’s out there and make up their own minds…)

That makes me a very bad person, for some people. Something I don’t really get, but… ours is not to reason why…

Here’s somebody saying I’m a very bad person:

http://nypress.com/18/25/news&columns/bergman.cfm

Here’s somebody trying to explain why we journalists need to report what’s in the medical journals:

http://nypress.com/18/25/news&columns/farber.cfm

Anyway, hope that helps.

Bests,

Liam Scheff

Liam @ 08/14/05 18:34:27

My letter sent to various AHRP letter writers:

————
Thank you for your spirited letters to the NY Times, regarding their recent attack on the investigation of the ICC/Columbia Presbyterian clinical trials story. They are appreciated.

I’d like to take this opportunity to introduce myself, and to perhaps lightly correct a few perceptions posited too easily by the NYT article.

I’m a journalist who has written about a variety of topics, politics, film, culture, oil and health/medicine.

And yes, ‘very independent’....Out of an hour’s interview on the technical aspects of AZT, Nevirapine, HIV testing and other drugs, [Janny] Scott decided (or pre-decided) to use only the half-joking, throw-away lines…bless her little (very little) heart.

I got into the field of AIDS because of an interest in what was not being reported in the papers, but what was clearly and continuously reported in the medical literature.

You can find examples of this in my article “Knowing is Beautiful.” I invite you to take a look, so you can better understand where my curiosity about the accuracy of the standard perceptions arises.

Hidden Face of HIV part 1 – Knowing is Beautiful (GNN):

http://gnn.tv/articles/article.php?id=1035

In my piece “The House That AIDS Built” (written and first pub’d in Dec.2003/Jan 2004, with some revisions to follow), I ascertained through interview that clinical trials were being conducted without parental knowledge or consent.

My first article came from interviewing a mother and her two children -residents of ICC; a former nurse, Jackie Hoerger; the executive director of ICC, Carolyn Castro (who quickly refused to interview; and the medical director, Catherine Painter, who spoke to me at length – as well as exhaustive review of the medical literature on drugs, tests and medical ethics in testing.

I ascertained through research that clinical trials were being conducted with a series of highly toxic molecules, mostly FDA black-box drugs, in dangerous combinations, as noted in the manufacturers package inserts, FDA-mandated warnings, and the Physician’s Desk Reference, as well as multiple – hundreds – of reviews in the medical literature.

I posited that the trials were in violation of the Nuremberg code, for reasons that I enumerated in the closing paragraphs.

The House that AIDS Built
http://www.altheal.org/texts/house.htm
the nurse’s story
http://www.altheal.org/toxicity/nurse.htm

Please note, that when I wrote the piece in 2003, I asked readers to contact various agencies to pursue the matter. AHRP was one of them.

I invite you to take a look, so that you don’t think that I presented only one argument, or story to the public. There is a perception, I think, in some of the letters published, that either Vera Sharav or John Solomon, whose work I do appreciate, did not use the leads I provided, or had to reinvent my work.

That is not the case.

They did good follow-through investigations, absolutely. But they didn’t originate the discussion of trial ethics.

They did choose to avoid, for political reasons, two issues that I presented (to my own peril, at times).

- The first is the primary of two sets of evidence that I have made room for in my reporting. This being about the quality and standardization of what we call HIV tests.

- The second is about the understanding, or lack thereof, of pathogenesis of HIV in persons we diagnose as HIV positive.

Talking about the published, mainstream contradictions of either of these topics is enough to get a reluctanct, recalcitrant and nearly hypnotized mainstream press to get away with ascribing certain “beliefs” or motives to you.

It doesn’t make those beliefs accurate or relevent.

Toward Open Research – Correction Letter to Nature Medicine

Response in Austin Chronicle – Welcomes Non-Partisan Critical Thinking

I should add that the reason I understood that these clinical trials were especially egregious is strictly because I had been writing about AIDS drugs and tests for a solid eight months prior, as part of a series on the topic in a Boston weekly.

But why contradict established scientific thought?

Because – I feel it is my job as a journalist serving the public’s right to information to report on the contradictions that are made available in the pages of mainstream medical journals:

Tests: http://www.aras.ab.ca/test.html

Drugs: http://www.aras.ab.ca/haart.html

Transmission: http://www.aras.ab.ca/transmission.html

In open debate at the British Medical Journal:
http://bmj.bmjjournals.com/cgi/eletters/326/7381/126/e

and

http://bmj.bmjjournals.com/cgi/eletters/326/7387/495#44654

I do share a question posited and reposited by researchers too slightly brave or politically unsavvy to know that asking a basic question is bad for their careers –

Does immune deficiency as described in persons we call AIDS patients actually have one and only one cause,

and are drugs that suppress immune function actually the one and only one cure for their immune defiency?

Who has asked this question? It has been put down to ‘a small minority.’

Maybe so, maybe not. In any case, here are some members of that unruly club, sharing their reasoning.

http://www.aras.ab.ca/aidsquotes.htm

Thanks again for your time and effort on behalf of the kids at ICC, and for your time and effort in correcting the NYT’s errors.

Sincerely,

Liam Scheff

P.S. This is my most recent, from the New York Press, July 2005.

An ICC insider tells her story, as do some of the former child residents.

See what you think:

Inside Incarnation – NY Press July 2005

http://www.nypress.com/18/30/news&columns/liamscheff.cfm

Liam @ 08/14/05 19:05:36

POST COMMENT

The Yard
content new pending
articles 1 280
headlines 1 2150
links 0 522
video 0 0
photos 0 0
promotions 0 0
Profile
Liam
Liam
Rebel
145pts
CMS
articles view add
headlines view add
blog view add
links view add
network view add
profile edit logout

Sign up for the GNN newsletter to get the first word on video premieres and breaking news. signup

Read the GNN FAQ for information about the site, forum rules and other GNN 2.0 information. faq

Optimized for FireFox
To download the Firefox web browser, visit mozilla.com Download Firefox

  • Advertise With GNN
  • SUPPORT GNN! Support GNN

    TEES/DVDS @ GNN STORE

    Buy Our Tees
  • Bloggers' Rights at EFF