Tuesday, March 15, 2005

Dear Ms. Mathis:

Thanks for the rapid reply. I stand corrected and will post your email on my blog.

Regards,
Michael Petrelis


In a message dated 3/14/2005 12:36:32 PM Pacific Standard Time, mathis@nytimes.com writes:
Dear Mr. Petrelis,

The initial article on David Ho's defensin discovery, in Sept. 2002,
noted that Ciphergen and Aaron Diamond would be applying for patents
on the discovery, with royalties going to Aaron Diamond. The point of
the 2004 article was that the previous conclusions about defensins
were wrong. The issue of patents was simply irrelevant, and in any
case, those patents were presumably rendered worthless.

Sincerely,

Catherine Mathis
VP, Corporate Communications
The New York Times Company
212-556-1981 (office)
917-593-7425 (cell)
mathis@nytimes.com
Dear Friends:

The San Francisco Superior Court judge who issued a ruling yesterday supportive of gay marriages, Richard A. Kramer, has made some rather interesting political donations over the past four years.

At the federal level, Kramer has made no donations, according to the PoliticalMoneyLine's web site tray.com.

In California races Kramer gave $500 in 2002 to openly lesbian Superior Court candidate Nancy L. Davis for her successful run.

In 2003 Kramer donated $500 to Californians for Schwarzenegger, according to the Secretary of State's database.

At the local level, during 2002 he wrote a check for $100 to openly gay Board of Supervisors candidate Bevan Dufty, who won his seat to represent the Castro district.

Kramer in 2003 also contributed $750 to Gavin Newsom's campaign for mayor of San Francisco.

He donated $500 that year to Newsom's opponent, former Supervisor Matt Gonzalez.

Kramer most recent donation, made in 2004, was a $500 donation to a former colleague, Lillian Sing, in her losing bid for a Board of Supervisors' seat.

You can find information on Kramer's donations to Judge Davis and Gov. Schwarzenegger at http://dbsearch.ss.ca.gov/ContributorSearch.aspx.

To verify Kramer's giving to San Francisco candidates, visit http://sunset.ci.sf.ca.us/olfspublish300.nsf.

Michael Petrelis
San Francisco, CA

Monday, March 14, 2005

March 11, 2005
From: gyamey@plos.org
Dear Michael,


As promised, I am writing to let you know about our competing interests policy as it applies to David Ho’s commentary that discusses the scientific reasons why he thinks an HIV vaccine could be developed.

We discussed this issue with David Ho, and also at our editorial meeting today.

As you know, we ask authors to declare financial ties that may be relevant to the specific article that they are writing. We ask all authors to look at our competing interests policy (http://www.plosjournals.org/perlserv/?request=get-static&name=interests) and declare any competing interests. So, for example, if an author in his/her article discusses a particular treatment, it would obviously be extremely important for that author to declare any ties to the manufacturer of that treatment.


In discussing the scientific reasons why he is optimistic that an HIV vaccine could be developed, Professor Ho did not believe that his financial ties had any specific relevance to the issue of the science behind HIV vaccine development (his ties are to manufacturers of antiretroviral therapies, and these manufacturers arguably stand to lose financially if a vaccine is developed).


As I mentioned before, we are constantly revisiting our competing interests policies (we are a new journal, and or policies are still evolving). We have had two examples now where readers have written in to say they felt that an author should have declared all their sources of funding (whether or not they were connected with the piece). This has prompted us to consider whether to ask all authors simply to declare all their sources of funding (leaving it up to readers to decide what is and is not relevant). This is one question that we will put to our external advisory group on competing interests once it is up and running.


I am sure that we do not have the perfect policy, but we are trying to come up with the one that works best (i.e. that allows readers to know whether financial ties could have biased the article). As we evolve, I will be sure to keep you informed. It is valuable for us to have feedback from our readers on how we are doing. Many—perhaps even most—journals still don’t have any policy at all about asking authors to declare competing interests. We have launched our journal with a policy that we realize may need revision.


Finally, please do look at our editorial that comes out at the end of this month (written by the PLoS Medicine editors). As with all articles, it will be freely available at http://www.plosmedicine.org/. It discusses our first steps towards adopting competing interests policies that can help to protect the probity of the journal’s content.


With thanks again for your interest in PLoS Medicine,


Best wishes


Gavin Yamey MD, MRCP

Magazine Editor, PLoS Medicine

Public Library of Science

- -

March 14, 2005

Dear Gavin:

Thanks for getting back to me, explaining more details about your journal's evolving policies on competing interests and what Dr. Ho had to say about why he didn't declare any in his recent article about AIDS vaccine research.

You wrote: "In discussing the scientific reasons why he is optimistic that an HIV vaccine could be developed, Professor Ho did not believe that his financial ties had any specific relevance to the issue of the science behind HIV vaccine development (his ties are to manufacturers of antiretroviral therapies, and these manufacturers arguably stand to lose financially if a vaccine is developed)."

My response is that Dr. Ho does have financial ties to AIDS vaccines.

According to the US Patent and Trade Office, filed papers in 2002 for HIV vaccine related invention. This is excerpt from the very long patent, where Dr. Ho is listed as the lead inventor:

"Vaccination of hiv infected persons following highly active antiretrovial therapy

"Abstract
"The present invention provides a method of permitting cessation of antiviral therapy on HIV-infected subjects without virus rebound or with at least a delayed virus rebound or a decreased post rebound set-point. The method comprises the re-induction of HIV-specific immune responses using a vaccination strategy to induce both humoral and cell-mediated immunity. The present invention achieves an immunological control of persistent infectious virus after discontinuation of antiviral therapy. The vaccine strategy according to the invention is both safe and immunogenic in the subject HIV-infected patient population.

"Inventors: Ho, David; (New York, NY) ; Markowitz, Martin; (New York, NY) ; KLEIN, MICHEL; (LYON CEDEX, FR) ; HABIB, RAPHAELLE EL; (LYON CEDEX, FR)
"Correspondence Name and Address: MCDONNELL BOEHNEN HULBERT & BERGHOFF
300 SOUTH WACKER DRIVE
SUITE 3200
CHICAGO
IL
60606
US


Serial No.: 182067
Series Code: 10
Filed: October 9, 2002"

I still think your journal should print an explanation for readers, detailing Dr. Ho's patent listed above, along with his other HIV-related patents.

Attached is a list of Dr. Ho's six patents, along with the four patents held by the Aaron Diamond AIDS Research Center.

Best,
Michael Petrelis

Sunday, March 13, 2005

March 14, 2005

Catherine Mathis
The New York Times
Corporate Communication

Dear Ms. Mathis:

I've sifted through the U.S. Patent and Trade Office's search engines and learned Dr. David Ho, director of the Aaron Diamond AIDS Research Center, is listed below as the inventor of six HIV tests, herbal extracts or agents.

Of particular interest to me, which I want the Times to pay attention to, is item number five on my list, "Defensins: as an antiviral agent," on the list below.

Dr. Ho's abstract to the patent office stated: "The invention further relates to methods for identifying and using agents, including small molecule chemical compositions, antibodies, peptides, nucleic acids, antisense nucleic acids, and ribozymes, that increase naturally occurring defensin expression or activity, thereby inhibiting HIV in a cell; as well as to the use of expression profiles and compositions in diagnosis and prophylaxis, and therapy related to HIV infection and related disease states such as AIDS."

Ho and his co-inventors filed the patent claim on May 30, 2003.

In a January 23, 2004, story by Andrew Pollack, headlined "AIDS Researcher Partly Retracts Study that Caused Stir," the Times reported how Ho and his colleagues made mistakes in an experiment with defensins.

However, the Times did not report that the test involved in the experiment is partly patented by Ho. I believe the paper should have informed readers of Ho's competing interests in this matter.

Now would be a good time to revisit what Pollack wrote, especially his omission of public information about the patent owners of the test used in the failed experiment.

If the Times feels it could have done a better job of delivering all the facts to the reader in this AIDS-specific story, a note to readers about Ho possessing the patent on the test would be appropriate.

Furthermore, as you see below, I've attached information from the patent office on all six of the patents that list Ho as an inventor, and four patents listing his laboratory, the Aaron Diamond AIDS Research Center, as the assignee for an invention.

Some of the inventions may have been used in analyzing specimens from the gay male patient in New York with a drug-resistant strain of HIV, extensively reported on in the Times. I say may have been used because I am not sure how many tests and of what sort were performed on the patient, or if Ho or his research center has patents on any of the tests.

If any of the tests used in the New York mutant HIV strain case are patented by either Ho or his laboratory, then I think the Times has a responsibility to tell readers these facts.

I suggest you determine if any Ho or Aaron Diamond AIDS Research Center patented tests were used in that case, to make sure the Times' coverage was as fully informed and accurate about transparency as possible.

I respectfully request a reply.

Sincerely,
Michael Petrelis
San Francisco, CA


^^^

U.S. PATENT AND TRADE OFFICE
http://www.uspto.gov/patft/index.html

SIX PATENTS THAT LIST DR. DAVID HO AS AN INVENTOR

1.
Chinese herbal extracts in the treatment of HIV related disease in vitro

Abstract
The invention features herbal extracts from ten (10) Chinese Herbal Medicines demonstrating significant in vitro and ex vivo anti-HIV activity and their use for the diagnosis and treatment of HIV and HIV-related disease.

Inventors: Ho; David D. (Chapqua, NY); Li; Xiling S. (Alhambra, CA)

Assignee: Cedars-Sinai Medical Center (Los Angeles, CA)

Appl. No.: 712062

Filed: June 7, 1991


2.
Immunoreagents reactive with a conserved epitope of human immunodeficiency virus type I (HIV-1) gp120 and methods of use

Abstract
The invention features immunoreagents which neutralize the Human Immunodeficiency Virus Type 1 (HIV-1) by binding to a novel conserved epitope of the HIV-1 gp120. These immunoreagents exhibit a broad neutralizing effect upon HIV attachment to host cells, and are therefore useful in the detection, prevention, amelioration and treatment of HIV disease, primarily AIDS (Acquired Immunodeficiency Syndrome) and ARC (AIDS Related Complex). More particularly, the invention relates to novel human monoclonal antibodies selectively reactive to a conserved conformation dependent determinant of the HIV-1 gp120, derivatives thereof, cell lines that produce these antibodies, and the use of the monoclonal antibodies and their derivatives for the detection, prevention, amelioration and treatment of HIV related disease.

Inventors: Ho; David D. (Capaqua, NY); Robinson; James E. (New Orleans, LA)

Assignee: Cedars-Sinai Medical Center (Los Angeles, CA); Louisiana State University and Agricultural and Mechanical College (New Orleans, LA)

Appl. No.: 870531

Filed: June 6, 1997


3.
Methods for identifying genomic equivalent markers and their use in quantitating cells and polynucleotide sequences therein


Abstract
Methods for identifying genetic sequences useful as genomic equivalent markers for organisms are described. The method involves determining the ratio of the absolute number of copies of wild type and mutant amplicons in a number of samples from organisms heterozygous for the mutation. After establishing the number of copies of a particular genetic sequence per genome, the sequence may be used as a measure of the number of genomes per sample, in order to normalize the analysis of another target sequence to abundance per cell. By way of example, the CCR5 gene was shown to be present at 2 copies per genome.

Inventors: Zhang; Linqi (New York, NY); Lewin; Sharon R. (Armadale, AU); Kostrikis; Leondios (New York, NY); Ho; David D. (Chappaqua, NY)
Assignee: The Rockefeller University (New York, NY)
Appl. No.: 481288
Filed: January 11, 2000



4.
Vaccination of hiv infected persons following highly active antiretrovial therapy

Abstract
The present invention provides a method of permitting cessation of antiviral therapy on HIV-infected subjects without virus rebound or with at least a delayed virus rebound or a decreased post rebound set-point. The method comprises the re-induction of HIV-specific immune responses using a vaccination strategy to induce both humoral and cell-mediated immunity. The present invention achieves an immunological control of persistent infectious virus after discontinuation of antiviral therapy. The vaccine strategy according to the invention is both safe and immunogenic in the subject HIV-infected patient population.

Inventors: Ho, David; (New York, NY) ; Markowitz, Martin; (New York, NY) ; KLEIN, MICHEL; (LYON CEDEX, FR) ; HABIB, RAPHAELLE EL; (LYON CEDEX, FR)
Correspondence Name and Address: MCDONNELL BOEHNEN HULBERT & BERGHOFF
300 SOUTH WACKER DRIVE
SUITE 3200
CHICAGO
IL
60606
US


Serial No.: 182067
Series Code: 10
Filed: October 9, 2002


5.
Defensins: use as antiviral agents


Abstract
The present invention relates to inhibition of viruses, e.g., HIV, using defensins. The invention further relates to methods for identifying and using agents, including small molecule chemical compositions, antibodies, peptides, nucleic acids, antisense nucleic acids, and ribozymes, that increase naturally occurring defensin expression or activity, thereby inhibiting HIV in a cell; as well as to the use of expression profiles and compositions in diagnosis and prophylaxis, and therapy related to HIV infection and related disease states such as AIDS.

Inventors: Zhang, Linqi; (Rochelle Park, NJ) ; Ho, David D.; (Chappaqua, NY) ; Caffrey, Rebecca E.; (Redwood City, CA) ; Dalmasso, Enrique A.; (Fremont, CA) ; Mei, Jianfeng; (Guilford, CT)
Correspondence Name and Address: TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US


Assignee Name and Adress: Aaron Diamond AIDS Research Center
New York
NY

The Rockefeller University
Fremont
CA

Ciphergen Biosystems, Inc.
Serial No.: 452763
Series Code: 10
Filed: May 30, 2003




6.

Comparative proteomics of progressor and nonprogressor populations

Abstract
The invention identifies polypeptide biomarkers of disease progression or nonprogression by comparative protein profiling of samples from progressors and nonprogressors subpopulations of a population exposed to the pathogen or sharing a risk facto causing the disease. The polypeptides, their ligands, and modulators find use as diagnostic, prognostic, and therapeutic agents.

Inventors: Rich, William E.; (Redwood Shores, CA) ; Ho, David D.; (Chappaqua, NY) ; Zhang, Linqi; (Rochelle Park, NJ)
Correspondence Name and Address: TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US


Assignee Name and Adress: Ciphergen Biosystems, Inc.
Fremont
CA

Aaron Diamond AIDS Research Center
New York
NY

The Rockefeller University
New York
NY
Serial No.: 452666
Series Code: 10
Filed: May 30, 2003




FOUR PATENTS THAT LIST THE AARON DIAMOND AIDS RESEARCH CENTER AS THE ASSIGNEE

1.
G-coupled receptors associated with macrophage-trophic HIV, and diagnostic and therapeutic uses thereof


Abstract
Entry of HIV-1 into target cells requires cell surface CD4 as well as additional host cell cofactors. A cofactor required for infection with virus adapted for growth in transformed T cell lines was recently identified and named fusin. Fusin, however, does not promote entry of macrophage-tropic viruses that are believed to be the key pathogenic strains in vivo. It has now been determined that the principal cofactor for entry mediated by the envelope glycoproteins of primary macrophage-tropic strains of HIV-1 is CC-CKR5, a receptor for the .beta.-chemokines RANTES, MIP-1.alpha., and MIP-1.beta..


Assignee: New York University (New York, NY); The Aaron Diamond Aids Research Center (New York, NY)
Appl. No.: 666020
Filed: June 19, 1996



2.
Sulfated CCR5 peptides for HIV-1 infection


Abstract
This invention provides a compound comprising the structure: .theta..alpha.YDINYYTSE.beta..lambda. wherein each T represents a threonine, each S represents a serine, each E represents a glutamic acid, each Y represents a tyrosine; each D represents an aspartic acid, each I represents an isoleucine; and each N represents an asparagine; wherein .alpha. represents from 0 to 9 amino acids, with the proviso that if there are more than 2 amino acids, they are joined by peptide bonds in consecutive order and have a sequence identical to the sequence set forth in SEQ ID.

Inventors: Dragic; Tatjana (Scarsdale, NY); Olson; William C. (Ossining, NY)
Assignee: Progenics Pharmaceuticals, Inc. (Tarrytown, NY); Aaron Diamond AIDS Research Centre (New York, NY)
Appl. No.: 796202
Filed: February 28, 2001




3.

Uses of a chemokine receptor for inhibiting HIV-1 infection

Abstract
This invention provides a polypeptide comprising a fragment of a chemokine receptor capable of inhibiting HIV-1 infection. In an embodiment, the chemokine receptor is C--C CKR-5. In another embodiment, the fragment comprises at least one extracellular domain of the chemokine receptor C--C CKR-5. This invention further provides different uses of the chemokine receptor for inhibiting HIV-1 infection.

Correspondence Name and Address: John P. White
Cooper & Dunham LLP
1185 Avenue of the Americas
New York
NY
10036
US


Assignee Name and Adress: Progenics Pharmaceuticals, Inc.

Aaron Diamond AIDS Research Centre (ADARC)


Serial No.: 852238
Series Code: 09
Filed: May 9, 2001



4.
Stabilized viral envelope proteins and uses thereof


Abstract
This invention provides an isolated nucleic acid which comprises a nucleotide segment having a sequence encoding a viral envelope protein comprising a viral surface protein and a corresponding viral transmembrane protein wherein the viral envelope protein contains one or more mutations in amino acid sequence that enhance the stability of the complex formed between the viral surface protein and transmembrane protein. This invention also provides a viral envelope protein comprising a viral surface protein and a corresponding viral transmembrane protein wherein the viral envelope protein contains one or more mutations in amino acid sequence that enhance the stability of the complex formed between the viral surface protein and transmembrane protein. This invention further provides methods of treating HIV-1 infection.

Correspondence Name and Address:

John P. White
Cooper & Dunham LLP
1185 Avenue of the Americas
New York
NY
10036
US

Assignee Name and Adress: Progenics Pharmaceuticals, Inc.

Aaron Diamond AIDS Research Centre

Serial No.: 780993

Series Code: 10

Filed: February 18, 2004

Friday, March 11, 2005

Subj: Your Query about Competing Interests
Date: 3/11/2005 3:23:52 PM Pacific Standard Time
From: gyamey@plos.org
To: mpetrelis@aol.com
CC: vbarbour@plos.org, pocampo@plos.org
Sent from the Internet (Details)


Dear Michael,

As promised, I am writing to let you know about our competing interests policy as it applies to David Ho’s commentary that discusses the scientific reasons why he thinks an HIV vaccine could be developed.

We discussed this issue with David Ho, and also at our editorial meeting today.

As you know, we ask authors to declare financial ties that may be relevant to the specific article that they are writing. We ask all authors to look at our competing interests policy (http://www.plosjournals.org/perlserv/?request=get-static&name=interests) and declare any competing interests. So, for example, if an author in his/her article discusses a particular treatment, it would obviously be extremely important for that author to declare any ties to the manufacturer of that treatment.

In discussing the scientific reasons why he is optimistic that an HIV vaccine could be developed, Professor Ho did not believe that his financial ties had any specific relevance to the issue of the science behind HIV vaccine development (his ties are to manufacturers of antiretroviral therapies, and these manufacturers arguably stand to lose financially if a vaccine is developed).

As I mentioned before, we are constantly revisiting our competing interests policies (we are a new journal, and or policies are still evolving). We have had two examples now where readers have written in to say they felt that an author should have declared all their sources of funding (whether or not they were connected with the piece). This has prompted us to consider whether to ask all authors simply to declare all their sources of funding (leaving it up to readers to decide what is and is not relevant). This is one question that we will put to our external advisory group on competing interests once it is up and running.

I am sure that we do not have the perfect policy, but we are trying to come up with the one that works best (i.e. that allows readers to know whether financial ties could have biased the article). As we evolve, I will be sure to keep you informed. It is valuable for us to have feedback from our readers on how we are doing. Many—perhaps even most—journals still don’t have any policy at all about asking authors to declare competing interests. We have launched our journal with a policy that we realize may need revision.

Finally, please do look at our editorial that comes out at the end of this month (written by the PLoS Medicine editors). As with all articles, it will be freely available at http://www.plosmedicine.org/. It discusses our first steps towards adopting competing interests policies that can help to protect the probity of the journal’s content.

With thanks again for your interest in PLoS Medicine,

Best wishes

Gavin Yamey MD, MRCP
Magazine Editor, PLoS Medicine
Public Library of Science
185 Berry St, Ste. 1300
San Francisco, CA 94107 USA
tel (+1) 415-624-1221
fax (+1) 415-546-4090
http://www.plos.org
Subj: Your query about David Ho's financial ties
Date: 3/11/2005 12:15:09 PM Pacific Standard Time
From: gyamey@plos.org
To: mpetrelis@aol.com
CC: vbarbour@plos.org, pocampo@plos.org
Sent from the Internet (Details)


Dear Michael,

Many thanks indeed for your call about this issue, which we are looking into, and which we are also discussing at our next editorial meeting. I'll keep you informed.

Incidentally, the issue of competing interests is one that we're taking seriously at PLoS Medicine. In fact, we're in the process of establishing an external, advisory group on competing interests (that includes a lay member). We will ask the group to help guide us on our policies, and we will also ask them about individual cases that arise.

As you know, we do ask all authors to look at our competing interests policy and ask them to declare ties that may be important for that particular article. We will certainly ask the advisory group to look at our policy.

Thanks for bringing this issue to our attention.

Best wishes,

Gavin Yamey
Magazine Editor

Thursday, March 10, 2005

January 20, 2005
Bay Area Reporter
(Not online. To respond, send email to BARpaper@aol.com or Matthewsbajko@aol.com )

San Francisco HIV cases continue to plateau
by Matthew S. Bajko

San Francisco's HIV epidemic has stabilized, and health officials reported this month they expect the trend to continue through at least 2007, if not longer. The leveling off is a turnaround from the late 1990s through 2001, when HIV incidence had a resurgence.

It also makes San Francisco unique, in that the country as a whole saw new HIV/AIDS diagnoses increase by 3.2 percent between 2001 and 2002. While health officials reported a slight increase among heterosexual cases and a decrease among injection 2002 numbers, San Francisco ranked 12th, falling behind Washington D.C. and Memphis.

"San Francisco has gone from being one of the most severely affected cities in terms of AIDS incidence to population to now having fallen to 12th. The leading cities have more injection drug users and heterosexual infections," explained Dr. Willi McFarland, director of the HIV/AIDS statistics, epidemiology, and intervention research section at the city's Department of Public Health. "It's not all good news, it's mixed. HIV incidence has leveled off, but at a rate that will continue to increase the number of MSM living with HIV."

As the city prepares to conduct its HIV consensus estimate this year ñ the last one was conducted in 2001 ñ the number of people living with HIV or AIDS is expected to stay about the same at 12,786. The number of new annual HIV infections, which had been 748, is expected to be "a little lower" said McFarland.

The numbers are a double-edged sword for the numerous AIDS agencies that work to maintain the successes San Francisco has achieved in battling the disease over the last two decades. Federal dollars that support AIDS and HIV care follow the epidemic, meaning San Francisco's piece of the funding pie is likely to continue to shrink.
America's AIDS epidemic is moving into the South, what some health officials are dubbing the "AIDS belt."

Among the top 10 cities for AIDS incidence in 2002, Miami ranked second, Baton Rouge ranked third, West Palm Beach came in fifth, Fort Lauderdale sixth, New Orleans seventh, and Columbia, South Carolina placed eighth.
Sitting in first place was New York City, an 800-pound gorilla when it comes to federal AIDS funds. Last spring, when San Francisco lost nearly $4 million in Ryan White CARE Act funding, local health officials said the drop was partly due to New York securing more funds than in years past.

In what has become a yearly report for the city's HIV Prevention Planning Council, McFarland presented the latest data and his predictions for where the city's AIDS epidemic is headed at the group's first meeting of the new year on January 13. He offered several reasons as to why health officials' fears in recent years of a resurgence in HIV have not panned out.

Their fears stemmed from rises in other sexually transmitted diseases, including syphilis and male rectal gonorrhea, both of which spiked upwards in 2000 and have continued to climb ever since. Both STDs can be a predictor for rises in HIV, for carriers are more susceptible to contracting the virus. But McFarland said that has yet to happen in San Francisco due to serosorting.

"We have seen an increase in STDs and unprotected anal sex and not have had HIV go up. This is due to networks of only positive men having sex with positive men and negative men only being with negative men," said McFarland. "If you separate out positive men, risk behavior has gone down since 2001."

The number of both positive and negative MSM reporting unprotected anal sex with a partner of the opposite serostatus has fallen in the last three years. But among men of the same HIV status, the number reporting unprotected anal sex has shot up since 2002. However, McFarland cautioned that serosorting might not be a viable HIV prevention strategy.

"It may not be a strategy over the long term that may be stable. How long will people choose someone of the same status?" he said.
Dear Friends:

Take a look at this excerpt from an article published by the Centers for Disease Control and Prevention:

>>The inadvertent use of Bicillin C-R, which contains only half the recommended dose of BPG for syphilis, was discovered after a patient treated for syphilis read the product insert, which stated that the medication was not indicated for treatment of syphilis.<<

This story from today's issue of the CDC's Weekly Morbidity and Mortality Report is disturbing for two reasons:

1. For five long years, the wrong treatment for syphilis was given to gay men at the LA Gay Community Center's and no one noticed. Considering the lengthy period of time involved in this situation, I wonder why the many health officials in LA, at the gay center and from the CDC were unaware of the problem. If these officials are not paying attention to proper treatments for STDs, and it takes such a long time for a problem like this to be uncovered, it does not instill much confidence in the oversight capabilities of these people.

2. Praise for uncovering the use of the wrong medicine must go to the patient cited in this report for doing what all of the health officials failed to do -- read the damn package insert!

Okay, it must be assumed it was too much trouble or took far too long to read the package insert and the health authorities, for five years, simply operated on blind faith.

Let's give a medal and job to the patient who uncovered what the health officials and all their degrees ignored.

Michael Petrelis
^^^



http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5409a1.htm

March 11, 2005
Inadvertent Use of Bicillin® C-R to Treat Syphilis Infection --- Los Angeles, California, 1999--2004

In March 2004, the Los Angeles County Department of Health Services (LACDHS) was notified that a large nonprofit clinic serving the gay and lesbian community in Los Angeles used a nonrecommended preparation of penicillin to treat syphilis patients during January 1999--March 2004. The clinic had inadvertently used Bicillin® C-R, a mixture of 1.2 million units (MU) benzathine penicillin G (BPG) and 1.2 MU procaine penicillin G, rather than Bicillin® L-A, a preparation that contains the 2.4 MU BPG per dose recommended by CDC (1). Bicillin L-A is recommended for treating syphilis and upper respiratory tract infections caused by susceptible streptococci (2). Bicillin C-R is indicated for streptococcal infections of the skin and respiratory tract; however, its efficacy in treating syphilis is unknown.

The inadvertent use of Bicillin C-R, which contains only half the recommended dose of BPG for syphilis, was discovered after a patient treated for syphilis read the product insert, which stated that the medication was not indicated for treatment of syphilis.

Review of clinic pharmacy records revealed that it received a shipment of Bicillin C-R in lieu of an unfilled order for Bicillin L-A in late 1998 and that the pharmacy subsequently ordered Bicillin C-R until March 2004. The clinic used Bicillin C-R as its exclusive formulation of injectable penicillin during January 1999--March 2004. This report summarizes the investigation of the misuse of Bicillin C-R at the Los Angeles clinic, which represents the largest occurrence of inadvertent treatment with Bicillin C-R to date. The investigation led to discussions among CDC, the Food and Drug Administration (FDA), and King Pharmaceuticals, Inc. (Bristol, Tennessee), whose Monarch Pharmaceuticals subsidiary markets Bicillin products. As a result, King Pharmaceuticals agreed to institute packaging and labeling changes to Bicillin products to prevent inadvertent treatment of syphilis with Bicillin C-R.

Five BPG-containing products are marketed by Monarch: Bicillin L-A, Bicillin® L-A Pediatric (0.6 MU BPG), Bicillin C-R, Bicillin® C-R Pediatric (a mixture of 0.3 MU BPG and 0.3 MU procaine penicillin G), and Bicillin® C-R 900/300 (a mixture of 0.9 MU BPG and 0.3 MU procaine penicillin G). Despite a change in package color in 2002 to distinguish Bicillin C-R from Bicillin L-A (3), the proprietary names and package appearances remained similar for the two formulations (Figure). The product insert sheet included a warning against the use of Bicillin C-R for treatment of syphilis.

Investigators reviewed databases from the clinic and from the LACDHS Sexually Transmitted Disease (STD) Program to identify patients who were treated during January 1999--March 2004 for confirmed syphilis infection or because of contact with a person known or suspected to have syphilis. All available data on treatment were evaluated.

During January 1999--March 2004, a total of 429 patients were treated with Bicillin C-R for confirmed syphilis infection at the clinic. An additional 234 patients were treated with Bicillin C-R at the clinic for reported sexual contact with someone who was known or suspected to be infected with syphilis (contacts). Of persons with confirmed syphilis, none were female, and 215 (50%) were known to be infected with human immunodeficiency virus (HIV). Five (2%) contacts were female, and 10 (4%) contacts were known to be infected with HIV. No female patients were pregnant during or after treatment with Bicillin C-R.

Clinic staff attempted to reach syphilis patients and contacts treated with Bicillin C-R by letter, up to three telephone calls, and, if necessary, telephone calls to emergency contacts listed on medical records. In addition, the clinic and LACDHS issued press releases to inform potentially affected patients and local health-care providers. LACDHS public health investigators attempted to reach patients whom the clinic was unable to locate or contact.

A standard protocol was developed to retest and retreat all patients and contacts who had been treated with Bicillin C-R for syphilis. All patients were offered retreatment regardless of retesting results. Patients with a confirmed syphilis diagnosis were evaluated by clinic medical staff, retested with quantitative rapid plasma reagin (RPR) tests, and advised to undergo lumbar puncture for cerebrospinal fluid analysis if they had either clinical manifestations suggestive of neurosyphilis or evidence of treatment failure (e.g., less than a fourfold decline in RPR titer since initial treatment). Contacts were tested with a specific treponemal test, and those with a reactive test were managed in the same way as those with a confirmed syphilis diagnosis. Patients were offered retreatment with a CDC-recommended regimen appropriate for their stage of infection.

As of January 26, 2005, of the 429 patients with confirmed syphilis, 282 (66%) were successfully contacted; 255 (59%) were retreated, 19 (4%) refused retreatment, and eight (2%) are pending evaluation. Of those who were retreated, 19 (4%) underwent lumbar puncture for suspected treatment failure. One patient treated for syphilis with Bicillin C-R subsequently had neurosyphilis diagnosed. Of the 234 contacts, 116 (50%) were successfully contacted, 98 (42%) were retested, and 15 (6%) are pending evaluation. Of the 98 contacts who were retested, 22 (22%) had serologic evidence of previous syphilis infection, and 19 (19%) were retreated; three (3%) refused retreatment.

Operations at the clinic were disrupted for approximately 6 months. The clinic reassigned professional and clerical staff to the evaluation and retreatment effort, and some clinic activities were postponed or canceled. In addition, LACDHS dedicated two public health investigators to this effort for nearly 4 months.

Reported by: R Bolan, MD, P Amezola, MPH, Los Angeles Gay and Lesbian Center; P Kerndt, MD, Los Angeles County Dept of Health Svcs, California. J Soreth, MD, Food and Drug Admin. M Taylor, MD, J Heffelfinger, MD, H Weinstock, MD, Div of STD Prevention, National Center for HIV, STD, and TB Prevention; M Greenberg, MD, M Janowski, MD, EIS officers, CDC.

Editorial Note:

Inadvertent use of Bicillin C-R for treatment of syphilis was documented in several STD programs during 1993--1998 (4). However, its misuse in treating approximately 660 persons in a Los Angeles clinic during January 1999--March 2004 is the largest reported occurrence to date and posed considerable clinical and programmatic challenges.

Compared with procaine penicillin G, use of BPG results in detectable serum concentrations that are prolonged (up to 30 days for BPG, compared with up to 7 days for procaine penicillin G). Prolonged serum concentration is considered essential for treating syphilis effectively because sustained spirocheticidal levels are required to treat the slowly reproducing agent of syphilis, Treponema pallidum. Treatment of syphilis with half the recommended dose of BPG might have increased the risk for syphilis treatment failure and neurosyphilis, particularly among those infected with HIV (5--7). However, treatment failure and neurosyphilis can occur even with recommended penicillin regimens in persons with and without HIV infection (8). Therefore, whether treatment failures that occurred among those treated with Bicillin C-R represent an excess over what would be expected had they been treated with Bicillin L-A cannot be determined without additional data. An investigation by CDC and state and local health departments is assessing whether treatment failure was more common in patients treated with Bicillin C-R than in a similar population treated with Bicillin L-A. Such inadvertent use entails discomfort and inconvenience to patients because it requires retesting and possible retreatment for syphilis. In addition, inadequate treatment of syphilis might have contributed to an increase in the local transmission of the disease.

In May 2004, CDC contacted FDA about the inadvertent use of Bicillin C-R. FDA worked with CDC and King Pharmaceuticals to design and implement changes to the product labeling, including more easily visible carton-color changes to distinguish L-A and C-R formulations, and the warning, "not for the treatment of syphilis," printed directly on syringes and cartons of Bicillin C-R. In November 2004, King Pharmaceuticals distributed a letter to clinicians, professional societies, and STD programs throughout the United States, alerting them to the potential for confusing Bicillin C-R with Bicillin L-A, the appropriate use of each formulation, changes in product labels, and mechanisms for reporting inadvertent use of Bicillin C-R for treatment of syphilis.

Education of clinic managers, pharmacists, and providers in the proper use of different penicillin preparations might help reduce the inappropriate use of Bicillin products. Providers, STD clinics, and pharmacies should review their product records and tracking systems for ordering and delivering penicillin treatments for syphilis.

References

CDC. Sexually transmitted diseases treatment guidelines 2002. MMWR 2002;51(No. RR-6).
Bisno AL, Gerber MA, Gwaltney JM Jr, Kaplan EL, Schwartz RH. Diagnosis and management of group A streptococcal pharyngitis: a practice guideline. Clin Infect Dis 1997;25:574--83.
Food and Drug Administration. Office of Drug Safety annual report FY 2002. Bethesda, MD: Food and Drug Administration; 2004.
CDC. Inadvertent use of Bicillin® C-R for treatment of syphilis---Maryland, 1998. MMWR 1999;48:777--9.
Rompalo AM, Joesoef MR, O'Donnell JA, et al. Clinical manifestations of early syphilis by HIV status and gender: results of the syphilis and HIV study. Sex Transm Dis 2001;28:158--65.
Lynn WA, Lightman S. Syphilis and HIV: a dangerous combination. Lancet Infect Dis 2004;4:456--66.
Collis TK, Celum CL. The clinical manifestations and treatment of sexually transmitted diseases in human immunodeficiency virus-positive men. Clin Infect Dis 2001;32:611--22.
Rolfs RT, Joesoef MR, Hendershot EF, et al. A randomized trial of enhanced therapy for early syphilis in patients with and without human immunodeficiency virus infection. N Engl J Med 1997;337:307--14.

Wednesday, March 09, 2005

Dear Friends:

In looking over the Federal Election Commission records of Joseph Solmonese, the Human Rights Campaign's new leader, I wasn't the least bit surprised that all of his donations since 1992 have been to Democratic candidates and PACs closely affiliated with the Democratic Party.

But what was amusing was seeing that Solmonese had donated twice to his predecessor at HRC -- Cheryl Jacques!

Maybe he should call her up and ask for advice on how to avoid becoming a failed executive director of a gay and lesbian political action group.

Considering his strong Democratic leanings and donations, it will be fascinating to watch Solmonese reach out to work with the GOP, Greens and independent voters and politicians.

Michael Petrelis
^^^

www.tray.com

SOLMONESE, JOSEPH
3/3/1992 $300.00
WASHINGTON, DC 20009
-[Contribution]
HUMAN RIGHTS CAMPAIGN FUND POLITICAL ACTION COMMITTEE


SOLMONESE, JOSEPH
5/8/1996 $200.00
WASHINGTON, DC 20009
-[Contribution]
FRIENDS OF ROSA DELAURO


SOLMONESE, JOSEPH
6/23/2001 $500.00
WASHINGTON, DC 20009
EMILY'S LIST -[Contribution]
CANTWELL 2006

Solmonese, Joseph R.
8/17/2001 $250.00
Washington, DC 20009
-[Contribution]
CHERYL JACQUES FOR CONGRESS COMMITTEE

Solmonese, Joseph
8/27/2001 $250.00
Washington, DC 20009
EMILY's List/Executive Director -[Contribution]
JULIA CARSON FOR CONGRESS COMMITTEE


Solmonese, Joseph R.
9/7/2001 $250.00
Washington, DC 20009
EMILY's List/Executive Director -[Contribution]
CHERYL JACQUES FOR CONGRESS COMMITTEE



Solmonese, Joseph
2/7/2002 $200.00
Washington, DC 20005
Emily's List/Executive Director -[Contribution]
FRIENDS OF NANCY KASZAK

Solmonese, Joseph
3/10/2002 $250.00
Washington, DC 20005
Emily's List/Executive Director -[Contribution]
FRIENDS OF NANCY KASZAK



Solmonese, Joseph R.
3/11/2002 $1,000.00
Washington, DC 20009
EMILY's List/Chief of Staff -[Contribution]
RIVERS FOR CONGRESS



Solmonese, Joseph
1/30/2003 $250.00
Washington, DC 20009
Emily's List/Development Director -[Contribution]
GAY AND LESBIAN VICTORY FUND



Solmonese, Jospeh
3/27/2003 $1,000.00
Washington, DC 20009
Emily's List/Chief of Staff -[Contribution]
JOHN KERRY FOR PRESIDENT INC

Solmonese, Joseph R
12/14/2003 $250.00
Washington, DC 20009
Emily's List/Development Director -[Contribution]
LISA QUIGLEY FOR CONGRESS

SOLMONESE, JOE
8/12/2004 $500.00
WASHINGTON, DC 20036
EMILY'S LIST -[Contribution]
CAMPAIGN FOR FLORIDA'S FUTURE FKA BETTY CASTOR FOR U S SENATE

SOLMONESE, JOE
9/29/2004 $500.00
WASHINGTON, DC 20036
EMILY'S LIST -[Contribution]
CAMPAIGN FOR FLORIDA'S FUTURE FKA BETTY CASTOR FOR U S SENATE

Solmonese, Joe R Mr.
7/21/2004 $1,000.00
Washington, DC 20009
EMILY's List/Chief of Staff -[Contribution]
EMILY'S LIST

Tuesday, March 08, 2005

March 8, 2005

Ms. Barbara Cohen
Senior Editor
PLoS Medicine
San Francisco, CA

Dear Ms. Cohen:

The February 2005 issue of your medical journal ran an article by Dr. David Ho of the Aaron Diamond AIDS Research Center, A Shot in the Arm for AIDS Vaccine Research.

Dr. Ho, in his competing interests statement, claimed he had no competing interests, which is simply not the truth on his part.

I have sent Dr. Ho the attached letter about his many ties to competing interests, including his relationship with
ViroLogic, where he sits on the firm's scientific advisory board and has stock options in the company, and to GlaxoSmithKline, where he advises the drug giant on awarding annual grants in AIDS drug research.

As you well know, such information is explicitly required for all authors who publish in your journal and your strict policy on what must be declared as a real or perceived conflict of interest is clearly stated. (Source: http://www.plosjournals.org/perlserv/?request=get-static&name=interests)

For many people with AIDS, including myself, we need more transparency from Dr. Ho and all AIDS researchers, so we can make informed choices with our doctors about the best course of treatment to fight AIDS and its many opportunistic infections.

In the interests of AIDS transparency, I ask you to immediately issue a correction to the press about Dr. Ho omitting his various competing interests in your February 2005 issue, that the correction quickly appear on your web site attached to his original article and print the correction in your next edition.

A prompt reply is respectfully requested and appreciated.

Sincerely,
Michael Petrelis
San Francisco, CA