Tuesday, January 31, 2006

Part D transition bills in the Senate

More or less competing Senate bills relating to the transitioning of dual-eligible clients to Medicare Part D prescription drug benefits have been filed. S. 2181 (by Lautenberg) and S. 2183 (by Rockefeller) were both introduced on January 20. Judging by the list of co-sponsors, both seem to be primarily Democratic bills. S.2181 is a fairly straightforward reduction of the clawback (reimbursement) required form states to pay Medicare for dual-eligible clients. The bill would reduce the clawback to compensate states for taking care of these clients during the transition period. S. 2183 looks to provide similar compensation, but it makes a few more substantive changes to the prescription drug program regarding staffing levels for prescription drug plans, 30- or 90-day supplies of medications for patients leaving Medicaid for Medicare, and so on. Both have been referred to committee.

Citizen Joe

Could be lack of sleep, could be lack of news, could be the distraction of all the deadlines that seem to fall in January, but I was having a hard time finding something to write about today until I ran across Citizen Joe. This is another resource for talking points and factoids that you can use when you are getting ready to talk to your representatives about your issues. Articles on health care, prescription drugs, and mental health include information that can be turned into persuasive arguments in favor of increased support for HIV/AIDS prevention and treatment and better public policies. The article on public health looks like it will address the issues of obesity, smoking, and AIDS, but, right now, only provides specific information on obesity.

I'd say that Citizen Joe is worth a bookmark and the occasional "dink-around" to see what they've updated or added to the site.

Friday, January 27, 2006

Disproportionate impact on women of color

The Kaiser Family Foundation web site has an archived copy of the webcast of "HIV/AIDS: The Disproportionate Impact of Women of Color in the U.S." (originally broadcast 1/10/2006).

Panel members of this briefing, sponsored by amfAR, Society for Women's Health Research and Women's Policy, Inc., discuss the disproportionate impact of HIV/AIDS on women of color, share experiences relevant to understanding this major health disparity and devise strategies to address the issue.

The page also includes a transcript of the event and downloadable files of the panelists' support slides. Among the gems in the slides is Cynthia Gomez' recommendations for "needed changes":

  • Improved education and sexual education
  • Universal/accessible healthcare, including coverage for immigrants in U.S. <>
  • Specific economic options for women
  • Stronger enforcement against domestic and sexual violence
  • Culturally and linguistically tailored services
  • Unlinking HIV, immigration, and citizenship
  • More alternatives such as microbicides
  • More programs that target heterosexual men
While some of these are familiar themes in the discussion of HIV, some are not--and yet they relate to factors that help drive the epidemic. There is more new thinking in the webcast. Give it a listen.

Thursday, January 26, 2006

More on the PrEP study

The Houston Chronicle's MedBlog, by Leigh Hopper, has an interesting dialogue going on about the tenofovir-as-HIV-prophylaxis study that we mentioned yesterday. Read Hopper's post and then read the comments. Kelly McCann from AIDS Foundation Houston gives an excellent assessment of concerns about the study.

Plenty of blame to spread around

Today's news summary from Kaiser points us to an op-ed by Flavia Colgan, who is apparently a commentator on MSNBC and former chief of staff to a Pennsylvania Lt. Governor. Her thesis according to the Kaiser summary is that there's plenty of blame to go around in the continuing spread of HIV/AIDS in the US. Colgan certainly does spread that blame around: Bush, Congress, gay men who continue to practice risky sex, people who complacently believe that cure is just around the corner and therefore practice risky sex, the media. It's a fairly feisty piece and well worth the read.

What it lacks, probably because of the space constraints of an op-ed, is any solution or call to action. Perhaps we can deduce that all of the things that she says are part of the problem could, if reversed, be part of the solution. We just aren't told how Colgan thinks we should go about getting them reversed. Then again, perhaps this is merely a starting point for Colgan:

Though these times often revolve around some hot button issues, more can be accomplished by settling down, leaning in, and having a serious conversation rather than by yelling. Such it is with the issue of AIDS. And though it is somewhat antithetical to my nature, I'm going to try to lean in, and ask you to do the same.

We look forward to hearing more.

Texas renews Medicaid coverage for Medicare dual-eligibles

Texas has joined at least 20 other states by stepping in to pick up the slack in the Medicare Part D prescription drug program. Press release here. I can't help but notice that the press release indicates that Texas waited to step in until there was assurance of federal reimbursement.

Wednesday, January 25, 2006

Viread and PreP

Hat tip to Reader "C" for the reference to this article on Viread: "Protect or Disinhibit?" from the New York Times. Jon Cohen writes about Project T, an international research project being underwritten by the CDC, NIH, and Bill and Melinda Gates Foundation. Project T is investigating whether tenofovir (brand name Viread) will work as pre-exposure prophylaxis (PreP) for HIV. If so, we will have yet another tool in our belt to prevent HIV.

Sounds good enough, but there are some additional concerns. "Disinhibition" is a new term for me, but it may become a favorite, along with "disinformation." Both terms apply, in this context, to something that leads folks away from the use of condoms to prevent the spread of HIV. Disinformation, in this context, would be false information that some folks are spreading about the effectiveness of condoms. Disinhibition, in this case, would be reliance on a pill for prophylaxis to the exclusion of barrier protection. An assumption of the research, it would seem, is that tenofovir would be used in tandem with condoms. A concern with the research project is that condoms would be abandoned for tenofovir.

Walgreens.com: tenofovir - condoms. I would say "You do the math," but, Cohen has further added to my education by introducing me to the 3 V's. [sigh]

Tuesday, January 24, 2006

Young people like abstinence

At least that's what the Washington Times is reporting about a Harris Poll on public opinion regarding whether abstinence-only sexuality education is effective in preventing preganancy and disease. The poll reports that the majority of Americans think that these programs don't work. However, when the survey group is broken down by age, the younger groups are more inclined to believe that abstinence-only education is effective. The older the surveyed group, the less likely they were to believe in that effectiveness.

The Times seems to think that this is surely proof that such programs are effective, since those who are the targets of the programs think they are. As the original source for their article, the Harris Poll, points out:

In reviewing these poll results, one should bear in mind that these results only measure perceptions. They do not provide any measures of the actual effectiveness of these programs. Furthermore, even a modest reduction in HIV/AIDS or unwanted pregnancies could reasonably be counted as a success. What this survey reveals is that most adults are skeptical about the effectiveness of these programs.

National (Medicaid) Call-In Week

HIV Medicaid/Medicare Working Group Alert

Last month, the House of Representatives voted for a budget bill that includes $4.8 billion in Medicaid cuts. The vote happened in the middle of the night, after having only a few hours to read the nearly 800-page bill. A few days later, Vice-President Cheney cast the tie-breaking vote in the Senate.

Because the Senate made some small changes to the bill, it must go back to the House of Representatives for a vote on February 1st. This gives us one more opportunity to tell our Representatives to vote NO on this mean-spirited attack on people who depend on Medicaid for lifesaving healthcare and treatment.

Join healthcare and low-income advocates around the country and help flood Congress with calls!

Take Action:

Starting January 23rd, call your U.S. Representative and tell whoever answers the phone: "My name is __________ and I live in (your town/city). I urge Representative (name) to vote NO on the budget bill. Cuts to Medicaid is a life or death issue for people with HIV and other vulnerable people."

You can call your Representative toll-free at 800-426-8073. You will get the Capitol switchboard. Ask to be connected to your Representative's office.

Please forward this Alert to your families, friends, and networks, and ask them to take action!

The HIV Medicaid/Medicare Working Group is a national coalition of advocates working to protect and expand Medicaid and Medicare for people living with HIV/AIDS. For more information about the working group, please write to leichou AT aol.com.

For more information about this Alert, contact:
Ryan Clary
Senior Policy Advocate
Project Inform
205-13th Street #2001
San Francisco, CA 94103
415-558-8669 x224
415-558-0684 fax
rclary AT projectinform.org

Widespread ED

Well, I just couldn't resist checking out this article when I got an email from the Archives of Internal Medicine: "Predictors and Prevalence of Erectile Dysfunction in a Racially Diverse Population." From the number of products available to deal with the issue, the amount of advertising that we are bombarded with, and the level of spam that shows up in my inbox, one can deduce that there is a lot of interest in the issue. The question that kept popping up in my mind (and I assume that of the researchers for this article) is whether ED was that significant a problem.

Problem or issue, the availability of ED drugs as party drugs is a concern to the HIV/AIDS community. One can't help but let that color one's thinking about all this advertising.

In step the reseachers (Christopher S. Saigal, MD, MPH; Hunter Wessells, MD; Jennifer Pace, BS; Matt Schonlau, PhD; Timothy J. Wilt, MD, MPH), and this is what they did:

Background To our knowledge, the burden of disease attributed to erectile dysfunction (ED) has not been adequately quantified across a complete spectrum of age and race using a global disease definition, as recommended by the National Institutes of Health consensus statement. To obtain a better understanding of the national estimates of prevalence and risk factors for ED, we analyzed data from the 2001-2002 National Health and Nutrition Examination Survey.

Methods The National Health and Nutrition Examination Survey collects data by household interview. The sample design is a stratified, multistage, probability sample of clusters of persons representing the civilian noninstitutionalized population. Data include medical histories in which specific queries are made regarding urological symptoms (including ED). These items were selected for analysis in 3566 men, 20 years and older.

Results In men 20 years and older, ED affected almost 1 in 5 respondents. Hispanic men were more likely to report ED (odds ratio [OR], 1.89), after controlling for other factors. The prevalence of ED increased dramatically with advanced age; 77.5% of men 75 years and older were affected. In addition, there were several modifiable risk factors that were independently associated with ED, including diabetes mellitus (OR, 2.69), obesity (OR, 1.60), current smoking (OR, 1.74), and hypertension (OR, 1.56).

Conclusions The burden of ED on the US population is significant. Hispanic men had an elevated risk for ED, a finding that requires confirmation in prospective studies. Obesity, hypertension, smoking, and diabetes mellitus are significantly associated with ED risk. Mitigation of these risk factors may ameliorate the burden of ED.

No doubt the manufacturers had an inkling of this when they were developing the drugs, and the FDA figured it out when it approved them. The contributing factors are widely studied as serious health issues in the nation, pointing us all more or less directly to the same conclusion that these scientists reached. The availability of this medication to treat a symptom of these serious conditions does not deserve to be the butt of jokes on late night TV.

This still leaves us with the question of how these drugs get to the street, where they triple in value and then get abused to reverse the effects of other abused drugs or simply to satisfy a male fantasy of superpotence. In the former case, impaired judgement can lead to the unsafe behaviors that promote the transmission of HIV. That's where our concern lies.

Arch Intern Med. 2006;166:207-212.

Monday, January 23, 2006

Fraud brochures now on Texas AIDS Net

The Texas AIDS Health Fraud Information Network published a brochure, "Don't Gamble with Your Health," a while back. (The brochure is also available in Spanish, "No juegue con su vida!") The task force uses the brochures to help folks recognize the red flags that pop up in advertising for products that often turn out to be fraudulent.

Now and then, the task force gets a request to have a brochure mailed out. In talking (well, emailing back and forth) about a recent request, someone said that we ought to have the brochures available for downloading. Several folks agreed. While having that all-important first cup of coffee, I decided to scan the brochures and convert them to PDF files. (It will take more than one cup of coffee to get more creativity here.)

Eventually, these files may show up on the TAHFIN web site. In the meantime, I've posted them on Texas AIDS Network's website in the Health Fraud section (scroll down to "Resources" and don't forget that these are about 500K PDF files).

(Drat! I lost one of the sidebars again! There are days when I want to beat FrontPage with a stick!)

Friday, January 20, 2006

Condom choice vs condom use

As we get closer to my favorite awareness week of the year (National Condom Week, of course), here's an interesting bit of research:

JAMAICA: "Does a Choice of Condoms Impact Sexually Transmitted Infection Incidence? A Randomized, Controlled Trial" Sexually Transmitted Diseases Vol. 33; No. 1: P. 31-35 (01.06.06):: Markus J. Steiner, PhD; Tina Hylton-Kong, MD; J. Peter Figueroa, MD; Marcia M. Hobbs, PhD; Freida Behets, PhD; Monica Smikle, PhD; Katie Tweedy, MPH; Sharon Powell; Linda McNeil, MPH; Alfred Brathwaite, MD

The authors investigated whether providing a choice of condoms would increase condom acceptability and self-reported use and decrease incident STD infection. The researchers randomized 414 men in Jamaica who presented with urethral discharge: Some men received the standard clinic condom, while others were given their choice of four different types of condoms. The men were presumptively treated at enrollment, and they were followed up at one, two, four, and six months.

Although participants in the choice group had a strong preference (P<0.01) for the most popular condom available in the nation, this did not equate to higher condom use (P=0.16). The six-month cumulative probability of first incidence of gonorrhea, chlamydia, or trichomoniasis was slightly greater in the choice group (21 percent; 95 percent confidence interval (CI), 15-28 percent) versus the control group (17 percent, 95 percent CI, 11-23 percent). The difference in survival curves was not significant.

The researchers concluded, "A choice of condoms may increase perceived acceptability but not lead to increased condom use and subsequently lower sexually transmitted infection rates." [emphasis added]

That implies, to me, that it takes a bit more than the mere availability of condoms to promote their acceptance and use. Active instruction on use and purpose is also needed with, perhaps, some new approaches to enhancing the understanding of condoms' importance to disease prevention.

Thursday, January 19, 2006

Skip the drug holiday

Lotsa news stories out now about the cancellation of the "drug holiday" study. For more detailed information about the study and why it was cancelled, see the NAIAD page that presents the information in Q&A format (with way too many acronyms). Says NAIAD:

How might these new findings affect the management of HIV disease?

The current U.S. Department of Health and Human Services (DHHS) Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents (Oct. 6, 2005) state: “Several clinical trials have been conducted to better understand the role of treatment interruption in these patients, yielding conflicting results. The Panel [the Panel on Clinical Practices for Treatment of HIV Infection convened by DHHS] notes that partial virologic suppression from combination therapy has been associated with clinical benefits, thus interruption is generally not recommended unless it is done in a clinical trial setting.”

The data from the SMART trial provide evidence that episodic use of ART based on CD4+ cell levels as used in the study is inferior to use of continuous therapy for treatment-experienced patients and thus should not be routinely recommended. [emphasis added]

New package labels for HIV meds (and others)

From the FDA:

The U.S. Food and Drug Administration (FDA) today (January 18, 2006) unveiled a major revision to the format of prescription drug information, including drugs to treat HIV/AIDS, commonly called the package insert or drug label, to make information for healthcare professionals clear and concise to help ensure safe and optimal use of drugs. Part of an effort to manage the risks of medication use and reduce medical errors, the newly designed package insert will provide the most up-to-date information in an easy-to-read format that draws attention to the most important pieces of drug information, thus reducing the complexity of information on prescription drug labels. The new format will also make prescription information more accessible for use with electronic prescribing tools and other electronic information resources.

The new drug labeling requirements will be phased in gradually, and initially will apply to newly and recently approved prescription drugs and drugs that receive approval for new uses. The agency is encouraging drug makers to consider complying with the new labeling requirements earlier on a voluntary basis. All drugs approved within the past five years are included, and they will gradually be converted to the new prescribing information format.
The new format requires that the prescription information for newly approved products and those approved within the last five years, meet specific graphical requirements, including the reorganization of critical information so physicians can find the information they need quickly. Some of the most significant changes include:
  • A new section called Highlights to provide immediate access to the most important prescribing information about benefits and risks.
  • A Table of Contents for easy reference to detailed safety and efficacy information.
  • The date of initial product approval, making it easier to determine how long a product has been on the market.
  • A toll-free number and Internet reporting information for suspected adverse events to encourage more widespread reporting of suspected side effects.

The most notable change is the addition of a summary, outlining the most important information about a product, prominently displayed at the top of the page to help healthcare professionals find the information they need quickly. This summary, called Highlights, will typically be half a page in length and will provide a concise summary of information about specific areas including: Boxed Warning, Indications and Usage, and Dosage and Administration; and will refer the healthcare professional to the appropriate section of the Full Prescribing Information. In addition, drug makers will be required to include a list of all substantive recent changes made within the year, to ensure healthcare professionals have immediate access to the most up-to-date information about the product before prescribing it.

A new Table of Contents will refer readers to detailed information located in the label. The Full Prescribing Information is reorganized to give greater prominence to the most important and most commonly referenced information. As a result of feedback from two national physician surveys, the Indications and Usage and the Dosage and Administration sections are moved to the beginning of the Full Prescribing Information.

The addition, a new Patient Counseling Information section places greater emphasis on the importance of communication between professionals and patients. This new section is designed to help doctors advise their patients about important uses and limitations of medications. It will also serve as a guide for discussions about the potential risks involved in taking a specific treatment and steps for managing those risks. If FDA has approved patient information for a prescription drug, it will be printed at the end of the label immediately following the Patient Counseling Information section or will accompany the label so it can be easily shared.

As prescription information is updated in this new format it will be added to a new online health information clearinghouse called DailyMed that will provide up-to-date medication information free to consumers, healthcare professionals and healthcare information providers. This information can be accessed through the National Library of Medicine at http://dailymed.nlm.nih.gov . Only one example is available at this time.

In the future, this new information will also be provided through a website called facts@fda, a comprehensive Internet resource designed to give one-stop access for information about all FDA-regulated products.

Comment: So now all they'll have to do is add a magnifying glass so you can read it.

Global health facts

The Kaiser Family Foundation has created a new website--Global Health Facts--to aggregate health data in a useable format. According to their press release:


The site provides access to detailed information on HIV/AIDS, tuberculosis, malaria, as well as data on demographic and economic indicators, other emerging health problems and program funding, and financing. New and updated data will be added regularly, and users can sign up for free email alerts with updates at www.GlobalHealthReporting.org/email.

I dinked around the site and found a table that listed the number of people living with HIV/AIDS in each country around the world and the global total (est. 40,300,000). By clicking on the column that showed the ordinal rank of each country, the data resorted to show that information. Eaither I didn't know or I had forgotten that the United States was in the top 10 among the nations for people living with HIV/AIDS. All the rest were in Africa, except #2, India.

I'd do my usual spiel about our needs here at home, except that I have a visual image somewhere in my memory bank of the continental US being overlaid on a map of Africa three times; Kenya (#8) is slightly smaller than Texas but has more than 300,000 more people living with HIV/AIDS. With numbers like these, let's just skip the spiel and file this one as a resource for the 25th Anniversary Score Card. (Preview: AIDS deaths - 3,100,000; Cures - 0.)

FDA to change herpes test classification

Following up on last week's post on this subject, I have tracked down the specific proposal at the FDA regarding changes to the guidelines for herpes tests.

The specific rule change is published in the January 9 issue of the Federal Register, pp. 1399-1403. The rule change places some herpes tests under less restrictive requirements with some special controls. The Federal Register notice outlines the history of the issue and provides reasons for the change. Comments are due by April 10. (See the notice for the specifics of where to comment--and remember that your comments will be available to the public, including any personal information that you submit.)

A draft of the guidance document for the special controls which will accompany reclassification are published in the same issue of the Federal Register and also on the FDA's web page: "Draft Guidance for Industry and FDA Staff--Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays" (also available in PDF). This document is also open for public comment.

Wednesday, January 18, 2006

Homelessness, Mental Illness, HIV: Missing links

A post in the Burnt Orange Report (BOR) caught my eye last Friday, partly because it touched on a topic of interest (homelessness) but also because there was an active discussion of the issue, which allowed for the airing of some interesting perspectives. I was particularly pleased to see the acknowledgement that homelessness is all too often linked with mental illness and the self-medication that leads to substance abuse. One link that was missing in the discussion was the role of HIV.

According to SAMSHA:

Epidemiological estimates indicate that about one-third of all homeless, single adults have severe and persistent mental illness and have marked neuropsychological impairments in attention, executive functioning, verbal memory, and general intellectual functioning. Substance use and abuse estimates are extremely high for homeless adolescents and adults, including alcohol and injection drug use (ranging from 20-80%). Available data suggest that in major urban areas, 10-20% of homeless persons who suffer from chronic mental illnesses are infected with HIV.
AIDS Housing of Washington explains why:

People with serious mental illnesses may be at increased risk for HIV infection. Reasons include higher rates of drug and alcohol use associated with high risk behaviors, a lack of safer sex education designed for people with major mental illnesses, and the increased vulnerability of people with mental illnesses to sexual assault and abuse, including in institutional settings. A study released in 2001 found that nearly half of people receiving care for HIV had a psychiatric disorder. Studies have also shown that depression is two to three times more common in people receiving HIV care than in the general population, affecting 22% to 32% of the total.
BOR points out that the National Coalition for the Homeless ranks Houston and Dallas among the top 10 meanest cities in the country if you're homeless. (Go read it.) Sounds like some city fathers (and mothers) are also missing the link. Dallas bulldozes homeless "housing" when it's too visible; Houston has a thing about BO (the smelly kind, not BOR) and bans sitting on the sidewalk. Meh.

Sunday, January 15, 2006

TagCloud

Look! I have a tagcloud!

I'm just having my first cup of coffee (yes, I slept in this morning) and am checking out a couple of sites from my Favorites list. One of them is complaining about Blogger being broken, so I just had to see for myself.

So what to my wondering eyes doth appear but a tagcloud! That's the odd list of words in blue and orange in the side bar. All of the words represent some level of frequency in the posts on Texas AIDS Blog. The larger and more orange the word, the more frequently it has been used.

The tagcloud is a free utility provided by TagCloud.com. I was just sure that I had installed it incorrectly or else lack something on the site (like tags, for instance). And now, exactly as advertised, it works! (Well, not exactly. I did think it would be faster. [reminding self to get some patience on the next shopping trip])

That being said, I am really surprised by the words that are showing up for frequencies. In a blog about HIV/AIDS in Texas, it's no surprise that those words show up with some frequency, but some of the others are puzzling. There are at least 10 articles that talk about concoms here, but only one shows up on the tagcloud search and that in the context of National Condom Week (well, it is my favorite awareness week). It would appear that the cloud only covers the past few days and not the whole site.

Even so, there is now a fourth option for getting access to information on Texas AIDS Blog: Blogger search button (upper left), Technorati search button (sidebar), Table of Contents (2004 and 2005), and the tagcloud. Now, if Blogger works . . .

Friday, January 13, 2006

Medicare Part D: Don't mess with Texas (HIV Medication Program)

Just had a chat with Dwayne Haught, director of the Texas HIV Medication Program, about how Medicare Part D transitions were progressing over there. The good news is that, while there are glitches all over the place, all THMP clients do and will remain on the program until their transition to Medicare Part D is settled. This means not only that they are signed up for an appropriate pharmacy benefit program but that they receive their meds and get the proper subsidy for their income level.

I suspected that this was the case, since the staff at THMP have been doing a lot of work to plan for the transition. They predicted many of the very challenges that are confronting other states and programs--long waits for information, conflicting information, errors in formularies, general foul ups in reimbursement, and so on. The decision to actually be a safety net in this transition is no surprise. It certainly is another reason to be proud of the commitment that Dwayne and other THMP staff members have to serving clients of the program.

Yoohoo! Over here!

Jamie McGeever writes for Reuters:

NEW YORK (Reuters) - Former U.S. President Bill Clinton announced on Thursday an initiative with nine drug companies he said would cut the cost of HIV/AIDS testing and treatment in 50 developing countries and help save hundreds of thousands of lives.

It's an admirable effort, and the companies that have stepped forward to participate share in the kudos that should be spread around on this.

Four companies - Chembio Diagnostics Inc, Orgenics, a subsidiary of Inverness Medical Innovations, Qualpro Diagnostics and Shanghai Kehua - will offer rapid HIV/AIDS testing at half the current cost and provide results within 20 minutes.
. . .
Another four companies - Cipla, Ranbaxy, Strides Arcolab and Aspen Pharmacare - will offer the first-line drug Efavirenz, with ingredients supplied by Matrix Laboratories, at below-market rates. Cipla will also provide the second-line drug Abacavir at lower cost.

What McGeever--and the many other news outlets that have picked up the story--has missed is that the U.S. is falling behind in its own approach to the epidemic.

  • The newly passed FY 2006 federal Labor/HHS appropriations bill includes a mere $10 million increase in funding for medications with cuts in prevention and services.
  • NASTAD reports that "of the 850,000 to 950,000 people estimated to be living with HIV/AIDS in the U.S., 42%-59% are not yet in the care system, including those who should be receiving highly active antiretroviral therapy (HAART) and other HIV-related medications.
  • In addition, NASTAD reports that "[a]s of March 2005, 21 ADAPs reported having one or more cost containment measures in place, including 11 with waiting lists representing a total of 627 individuals.
  • NASTAD's report did not include the waiting list for Fuzeon at the Texas HIV Medication Program (THMP)--62 today.
  • THMP added nearly 200 new clients because of the dislocations caused by Hurricane Katrina; reimbursement for the unbudgeted costs to the program from federal disaster relief is still uncertain.
  • Even without the Katrina factor, THMP was already projecting a shortfall in funds in the current biennium, placing the program at risk for instituting additional cost containment measures (current estimate: $6 - 7 million).
  • The uncertainties caused by the implementation of Medicare Part D and the still-reauthorized Ryan White CARE Act compound the difficulty of making even conservative budget forecasts for the future.

As pleased as we are by President Clinton's efforts on behalf of the developing world, it's still hard not to want to stick our head out the window and shout: "Yoohoo! Over here! We could use some help, too!" Still, if Mr. Clinton is busy taking care of the rest of the world, there's no reason not to do a little noodging of the U.S. press. There's plenty to write about here at home besides celebrity hairdos and sports scores. So maybe we should stick our heads out our windows and give our press a shout: "Here's a story that needs covering!"

National Minority Campaign for Ryan White Reauthorization

The National Minority Health Month Foundation (NMHMF) today announces a broad-based national campaign aimed at encouraging the U.S. Congress to support the reauthorization and modernization of the Ryan White Comprehensive AIDS
Resources Emergency (CARE) Act in 2006.


According the NMHMF press statement from January 10, the concerns are disparities in care for minority communities per se and within the geographic regions of the country.

I inquired about additional information about the specifics of the campaign. I am told that they are in the process of updating their web site, and new information should be available shortly.

Thursday, January 12, 2006

Teleconference on Fair Housing Laws

PATH Teleconference on Fair Housing Laws Thursday, January 19, 2006 from 2:00 - 3:30 pm EST [1:00 - 2:30 CST]

. . . a teleconference on the Fair Housing Act and other disability rights laws that affect you, your clients, and the housing and service providers with whom you work.

Bonnie Milstein will be the featured presenter and will explain why you need to know the basics of the Fair Housing Act, the ADA and Section 504; where to find answers to your questions; and how the laws can help your clients hold onto their housing. Bonnie is an attorney and founding partner of Magar and Milstein, a civil rights advocacy, law, and consulting firm in San Francisco, California. The firm specializes in affordable housing and disability rights issues.

Send Bonnie any questions that you would like her to answer and she will include them in the teleconference. Her email is bmilstein AT sbcglobal.net.

This audio conference will be broadcast over the PATH website, www.pathprogram.samhsa.gov. The link to the call will be "live" at 1:30 pm EDT [12:30 CST] on Thursday, January 19th.

If you have any questions, please contact me Margaret Lassiter, MA at 518-439-7415 ext. 230.

I'm guessing that China and Texas

. . . have a lot in common on this one. And I don't mean Chinese-Texans.

CHINA: "Relation of Sexual Risks and Prevention Practices with Individuals' Stigmatising Beliefs Towards HIV Infected Individuals: An Exploratory Study" Sexually Transmitted Infections Vol. 81: P. 511-516 (12..05):: H. Liu; X. Li; B. Stanton; X. Fang; R. Mao; X. Chen; H. Yang

In the current study, the authors sought to investigate how a person's stigmatizing beliefs toward HIV-infected individuals are related to his or her own sexual risk and protective behaviors. To assess HIV-related stigmatizing beliefs, risky sexual behaviors, and preventative practices, the researchers conducted a cross-sectional survey on sexually experienced rural to urban migrants ages 18-30 in Beijing and Nanjing in 2002.

Of the 2,153 migrants surveyed, 7.2 percent reported having had more than one sexual partner in the previous month; 9.9 percent had commercial sex partners; and 12.5 percent reported an episode of an STD. Just 18 percent reported frequently or always using condoms, with 20 percent sometimes or occasionally using them. Fifty-seven percent of the migrants were willing to take a voluntary HIV test, and 65 percent reported HIV-related stigmatizing beliefs towards HIV-infected individuals.

Multiple logistic regression analysis found that migrants with stigmatizing beliefs toward people living with HIV were positively associated with having multiple sex partners, having had a STD episode, or having had commercial sex partners, and were negatively associated with condom use and willingness to take an HIV test.

"The finding that one's own stigmatising belief is a potential barrier to HIV related preventive practices highlights the difficulties and challenges in implementing behavioural interventions," the authors concluded. [Emphasis added, of course]

[CDC News]



FDA to ease rules on herpes tests

UNITED STATES: "US Government Proposes Easing Rules on Making, Administering Herpes Tests" Associated Press (01.06.06)

In a proposed rule released Jan. 6 but dated Dec. 21, the Food and Drug Administration said it may change how it classifies tests for herpes simplex virus types 1 and 2, reducing the regulatory burdens associated with the tests. Julie Zawisza, FDA spokesperson, said the change could make the tests easier and more available. The modified policy would lower the entry barrier for companies seeking to develop and market these tests and relax training requirements for labs and medical offices that offer them, she said. As far back as 1980, FDA was considering reclassifying the tests but balked at doing so because of concerns over the health of newborns. At the time, FDA found the tests presented a "potential unreasonable risk of illness or injury." A false positive on an older test could lead to unnecessary treatment with antivirals or unnecessary Caesarean delivery, while a false negative could lead to a potentially fatal herpes infection in the newborn. In explaining its reasoning for proposing the reclassification, FDA said the reliability and performance of the tests have improved in the past 25 years. The agency will accept comments on the proposed change through April 10. For more information, visit www.fda.gov.

[CDC News]
Note: I haven't seen the rules, but will try to find a more specific reference for review and comment.

HBV blood tests recalled

UNITED STATES: "Blood Tests for Hepatitis B Recalled" Reuters (01.10.06)

On Monday, Johnson & Johnson and US regulators said the company has recalled some blood tests for hepatitis B virus because they may give false negative results. The affected products, which were distributed in the United States and Europe, have been replaced, said Mary Richardson, spokesperson for the Johnson & Johnson's Ortho-Clinical Diagnostics unit. The problem has been discovered in three lots of the Vitros Immunodiagnostic HBsAG Confirmatory Kit, Richardson said. An unknown component in the diluting solution may produce a false negative result for samples that initially tested positive. Johnson & Johnson is not aware of any cases in which an incorrect result was given to a patient, said Richardson. The company is asking health care facilities and agencies that received the recalled tests to review previous results. For more information, visit www.fda.gov/medwatch/safety/2006/safety06.htm#vitros.

[CDC News]

Wednesday, January 11, 2006

More Katrina resources

Austin Free-Net, also a member of Another Way Texas Shares, has notified us of a web-based resource that they have developed for case managers who are working with Katrina evacuees. The site includes links to forms and resources for assisting evacuees with Medicaid, housing and other services.

As a reminder, clients who would like assistance from the Texas HIV Medication Program must now get a waiver from Texas Medicaid. Their notice:

As of November 2005, all Katrina evacuees applying for assistance to the THMP ust FIRST apply for a Texas Medicaid waiver, which will be available to all evacuees through January 31, 2006. You can call either 2-1-1 or the Hurricane Evacuation Hotline at 1-888-312-4567 for information and referral to your local Texas Medicaid office. Please note that the THMP is required to be the payer of last resort AFTER you have exhausted your prescriptions through Louisiana or Texas Medicaid. Louisiana Medicaid recipients can use a mail order pharmacy in Louisiana such as Avita Drugs to obtain their medications; you can call Jerry Purcell with Avita Drugs at 1-800-299-0547 for additional information.

See THMP's news page and scroll down to the September 1 (updated November 30) news story for more information. (Sorry, they don't have bookmarks for a more specific link.)

HCV in HIV-infected patients

Medscape (sub. req.) article:

Clinical Presentation and Course of Acute Hepatitis C Infection in HIV-Infected Patients.
Annie Luetkemeyer, MD; C Bradley Hare, MD; John Stansell, MD; Phyllis C Tien, MD; Edwin Charlesbois, MPH, PhD; Paula Lum, MD, MPH; Diane Havlir, MD; Marion Peters, MD
J Acquir Immune Defic Syndr. 2006;41(1):31-36.

Summary:

Hepatitis C virus (HCV) has become a significant source of morbidity and mortality in HIV-infected patients. However, little is known about the clinical presentation and course of acute HCV infection in this population. This study reports the outcomes of acute HCV infection in 9 HIV-infected men. Sex with men was the only reported risk factor for HCV infection in 6 of the subjects. Clinical presentation of acute HCV ranged from incidentally discovered elevated transaminases to severe liver dysfunction requiring hospitalization. At the time of HCV diagnosis, 8 of 9 patients had CD4+ counts >250 cells/mm3, and 6 had HIV viral loads of ≤5000 copies/mL. Eight patients were receiving antiretroviral therapy. Outcome of these acute HCV infections varied. Five patients experienced virologic clearance, 2 in whom virus cleared spontaneously and 3 who were treated with pegylated interferon and ribavirin. Four patients developed chronic infection, one of whom had a relapse during HCV treatment and 3 of whom were untreated. All 4 patients to whom HCV therapy was administered experienced significant anemia or neutropenia, necessitating dose reduction or support with growth factors. Prompt recognition of acute HCV infection may minimize antiretroviral treatment interruption and will allow early treatment, which may improve virologic clearance. Unexplained transaminase elevations in HIV-infected patients, including men who have sex with men, should trigger an evaluation for acute HCV infection.

Tuesday, January 10, 2006

What (the other) Marsha said

There must be something about gal's named Marsha. I do like what they say. This time it's Marsha Hurst from a blog called The Health Advocate, talking about the frustrations of selecting a plan for Medicare Part D:

Yes, most of us who are in the health professions could probably do what Lisa Doggett did, but first, as my mother always told me, time is money. I was already appalled at how long it took to compare plans on the Medicare site: you can only do three at a time. What is that all about? And some plans have no donut hole, so you really have to look carefully to do the comparison because premiums are deceptive. And then, if you are not an MD with some prior knowledge of these drugs, the research it would take to take the next steps Doggett advises is daunting: check to see if there are OTC equivalents, find the formularies, make reasonable judgments about substitutions, contact the various doctors and get approval for these changes. No, it is frankly an outrage that this kind of research is required in order to make the best decision about a Medicare “benefit” plan. Certainly this is a new kind of elitism: the small group of older people who have younger relatives who are doctors willing to spend this kind of time (primary care probably) form the elite group who will be able to make the smartest shopping decisions. [emphasis added]

The whole article is worth a read, not merely because Ms. Hurst gives vent to the frustrations that many of us are feeling right now as we try to figure out those Part D formularies. Some folks that I know are making their own spreadsheets, very tediously, by making small searches on the Medicare database and trying to come up with the comparisons that will make it simpler for Texans with HIV to make plan decisions.

This evening, I did manage to find a source that purports to have all of the formularies in one place for easy downloading. Now all I have to do is buy a PDA to read it. [sigh] Without a computer or a PDA or a physician in the family, one does have to wonder how ordinary folks manage this. Oh right, the legacy version of spam--junk mail.

All snark aside, there really are some good things to be found in the Medicare Part D benefit, not the least of which is the advantage for people living at 150 percent or less of Federal Poverty Guidelines. But for the rest of the folks who are eligible for Medicare, the wrong decision can be costly.

Google Video for HIV/AIDS Discussions

Google has introduced a new service, Google Video, which makes commercial and private films and videos available, sometimes for free, often for a fee. I checked out the service with searches for "HIV" and "AIDS." The mix of videos available is eclectic, to say the least: some promos, some amateur productions, some clips from longer television programs, some academic presentations, some policy presentations, a lot of city council meetings. If you have time to check some of them out, you may even find something useful.

I didn't understand the point of this.
I may understand this, but I had to work at it.
I liked the image of the balloons in the sky in this.
Phil Donahue moved me to tears in his discussion of PFLAG, although he barely mentioned AIDS.

National Healthcare Disparities Report

The National Alliance for Hispanic Health calls our attention to the newly issued National Healthcare Disparities Report prepared for the U.S. Department of Health and Human Services (highlights here). According to the Alliance's press release:


Among the worsening disparities for Hispanics (compared to non-Hispanic whites) reported by DHHS today were:
• Declines in diabetes care quality (at the same time it improved for non-Hispanic whites);
• Higher rates of new HIV/AIDS cases experienced by Hispanics;
• Disparities in access to mental health treatment for serious mental illness;
• Longer and more frequent delays in illness/injury care for Hispanic patients; and
• Lack of smoking cessation counseling for hospitalized Hispanic smokers.
The report documents disparities for other groups, including Asians vs. whites, Native Americans vs. whites, African-Americans vs. whites, and poor vs. rich. For African-Americans vs. whites, for example, an even higher rate of new HIV/AIDS cases is documented. The report itself makes no proposals for remedying the healthcare disparities that it documents. However, the Alliance has issued a 5-point plan for remedying the healthcare disparities documented for Hispanics.
  • Point 1. Working within the already agreed funding set for CDC by Congress for Fiscal Year 2006, reconfigure funds to achieve a doubling of the budget for Hispanic community based services with the majority of funds supporting an expansion of Hispanic services within the National Center for Chronic Disease Prevention and Health Promotion.
  • Point 2. Establish an adequate budget within the Centers for Medicare and Medicaid Services (CMS) to deliver counseling and outreach services through Hispanic community based agencies and achieve 100% sign-up of Hispanic children and adults eligible for either Medicaid or the Children’s Health Insurance Program but not signed up for the program.
  • Point 3. Issue a report on the costs and authorities required to expand eligibility under the Children’s Health Insurance Program to the parents of eligible children up to 150% of the Federal Poverty Level.
  • Point 4. Establish a model for a specific billing code for private insurers to reimburse certified medical interpreters and issue a report on the costs and authorities needed to implement the billing code under federally supported programs (Medicare, Medicaid, CHIP).
  • Point 5. Release National Institutes of Health (NIH) data on the number of supported Hispanic principal investigators (PIs), the budget for Hispanic community education programs, and a plan for doubling the budget for Hispanic community education by the next fiscal year in each Institute and Center.

Where are the 5 (or 7) Point Plans for the other groups?

Monday, January 09, 2006

Change in federal grant submission requirements

Two federal web sites for grant applications have now been consolidated. Both are now under the umbrella of the Grants.gov e-government project. The merger eliminated Fedgrants.gov.

In addition, HRSA will no longer accept applications for grant opportunities in paper form for grant opportunities posted after January 1, 2006. Specific instructions are available in the grant announcement posted on http://grants.gov/. According to the HIV/AIDS Bureau,

Applicants submitting new and competing continuations and a selected number of non-competing continuation applications will be required to submit electronically through Grants.gov for all opportunities posted after January 1, 2006. All applicants must submit in this manner unless the applicant is granted a written exemption from this requirement in advance by the Director of HRSA's Division of Grants Policy. Grantees must request an exemption in writing from DGPClearances AT hrsa.gov and provide details as to why they are not able to submit electronically though the Grants.gov portal.

HRSA recommends that current grantees and applicants register on the Grants.gov site and familiarize themselves with the application process through that site. Help is available on the site, by email (support AT grants.gov), or by calling 800-518-4726.

Article: HIV seroconversion among IDUs

"The Impact of Sex Partners' HIV Status on HIV Seroconversion in a Prospective Cohort of Injection Drug Users" Journal of Acquired Immune Deficiency Syndromes Vol. 41; No. 1: P. 119-123 (01.01.06):: Thomas Kerr, PhD; Jo-Anne Stoltz, PhD; Steffanie Strathdee, PhD; Evan Wood, PhD

The identification of persons at highest risk for HIV infection is crucial for targeting prevention strategies, the authors noted. In this study, researchers evaluated the HIV status of injection drug users' (IDUs) sex partners and rates of subsequent seroconversion among participants of the prospective Vancouver Injection Drug Users Study.

Of 1,013 IDUs who were HIV-negative at baseline, 4.8 percent reported having an HIV-positive sex partner. Kaplan-Meier methods were used to estimate cumulative HIV incidence. After 18 months, the cumulative HIV incidence rate was significantly elevated among those reporting having an HIV-positive sex partner (23.4 percent vs. 8.1 percent; log-rank P less than 0.001). In a Cox regression model adjusting for all variables associated with time to HIV infection in univariate analyses, including drug use characteristics, having an HIV-positive partner was independently associated with time to seroconversion (relative hazard=2.42 [95 percent confidence interval: 1.30 to 4.60]; P=0.005).

"Having an HIV-positive sex partner was strongly and independently associated with seroconversion after adjustment for risk factors related to drug use," concluded researchers. "Our findings may aid public health workers in their efforts to identify IDUs who should be targeted with education and prevention efforts and indicate the need for ongoing development of prevention interventions for IDU sex partners who are HIV discordant."

[from CDC news]

Getting our feet wet in the blogosphere

Over the past few weeks, we've been working to find ways to make Texas AIDS Blog more accessible to the community.

One problem was internal navigation: How do you find information that interests you on this site when there are only so many posts on the front page and the archive list is fairly inscrutable?
  • One solution to that is noted in the previous post regarding tables of contents.
  • Another solution was to add Texas AIDS Blog to Technorati's database and post their search button on the sidebar. I've tested the search function with several key words and find it much more efficient than the Google search function provided by Blogger.
  • Yet a third solution, the tag cloud, doesn't seem to be working out, so we'll have to study that one a bit more.

Another problem was just simply knowing that Texas AIDS Blog exists and finding it. We have quite a ways to go in promoting the blog as a service for the Texas HIV/AIDS community, but we made a start by adding the blog to several blogging indices recently. Little "bugs" for these indices are starting to pop up in the side bar. If you use Technorati, Blog Digger, ReadABlog, BlogStreet, Globe of Blogs, BlogHop, BlogWise, Bloogz, BlogPulse, or PubSub, we've submitted the blog to those sites, and we should be showing up there soon, if not already.

A further issue is how to make Texas AIDS Blog accessible as a regular source of information for the community. We've already talked about adding email subscriptions via FeedBlitz [nodding "hello" to our subscribers there] or subscribing through Feedburner. As elegant as those solutions are, that doesn't quite get us to other feed services. That apparently requires an RSS feed, which I understand but don't quite know how to do yet.

One final note. I mentioned that I had tinkered with some settings last week and somehow managed to mess up the feed that was coming through Feedblitz. Almost as soon as that post went out, a fellow from Feedblitz' support section contacted me by email to tell me what the problem was. Notice that I didn't mention asking for help--but still the help came. Is that service or what? Thanks, Phil!

Thanks for coping with my learning curve. I think this will be the last of the "technical" posts until I learn more about that RSS feed thingie. Now for the news . . .

Table of Contents for Texas AIDS Blog

Announcing the Texas AIDS Blog Table of Contents: 2004 and Table of Contents:2005 now available on Texas AIDS Net. You can browse the entire list of blog posts for 2004 and 2005, click on the titles that interest you, and read past, but not so old, news and information for the Texas HIV/AIDS community.

Calendar irony

I just updated the calendar of Important Dates over on Texas AIDS Net with a reminder that February 13 is the deadline for commenting on the new condom rules being proposed by the FDA. The very next day marks the beginning of the annual National Condom Week. Do you think someone at the FDA has a sense of humor?

Saturday, January 07, 2006

Saturday fun time

I was so not intending to post today. It's Saturday, for garden seed! But I sometimes do that dink around thing on the Internet and find interesting stuff. Today's "Dink Around" netted some real goodies.

This commercial for glow-in-the-dark condoms made me laugh out loud. Somehow I doubt we'll ever see this on U.S. TV.

A Colorado couple bought filbert nuts from a WalMart Supercenter. They were somewhat surprised to find a bright yellow condom inside. The police decided that no law had been broken, but WalMart was seriously chapped about the food tampering issue. The incident got fairly wide coverage in odd places. Is a filbert like a hazelnut?

Allafrica.com reports on "sewage sociology": lots of condoms showing up in the new sewage treatment plant near Manzini, Swaziland. Good news that in a country with 40 percent of the adult population HIV-positive. Unfortunately, there aren't enough sewage treatment plants to tell how widespread condom use might be in other areas of the country.

Betcha can't guess what my search term was!

Friday, January 06, 2006

Template issues?

I don't know why today's feed via FeedBlitz (the email notification of new posts) showed up with only post titles instead of the usual snippet of text. I did tinker with the some of the options in Feedburner (the software that sends out the feed) so that you could start emailing this baby all over the world. (One always allows oneself to dream.) Today's notification came with just that: a post title and an option to email. [sigh]

I also tinkered with the template last night. I continue to try to find ways for readers to dig into the blog. The front page only shows a few posts, the most recent ones, and the rest scroll off into "archives." The archives are all nice and tidy, but how do you know what you're going to get when you click on, say, "March 2005"? The little Google search function didn't actually work for me when I tested it with the word "condoms." Given how many rants I've posted about the War on Condoms, I expected more results. No joy.

To enhance access to the site, I've been working on a couple of things. One is, of course, still in the works, since it involves a lot of manual effort. Another was the TagCloud thingie. I found a tagcloud generator that would search for keywords in my posts and added it last night. The intention was to have at least a box where you could see the most common 30 or 40 keywords and click on one to find all of the posts that contained that key word. Right now, the darned thing is just sitting there, telling me to be patient. Hmph! Maybe I put something in the wrong place on the template. (Fools rush in . . .)

I'll keep tinkering with it, but apologies in the meantime for the anemic feed.

HRSA explains Medicare Part D

The following item came via yesterday's email from the HIV/AIDS Bureau at HRSA:

*** HRSACAREAction Addresses Medicare Part D Drug Coverage Programs***
The latest issue of the HRSACAREAction newsletter addresses the new Medicare Part D Drug Coverage Programs. Included in this issue is: the new Medicare Drug Plan's implications for people living with HIV/AIDS; an overview of the Medicare Part D Drug Coverage Program; what counts toward true out-of-pocket costs; special requirements for formulary inclusion of antiretrovirals; the CARE Act and Part D Policies; and Federal resources. - To view this issue go to: <http://hab.hrsa.gov/publications/october2005/>.

The page is all that it is said to be and more--quite a useful reference tool. However, one does have to wonder why the "latest issue" is dated October 2005 and is only now being announced by HAB. Worse, from the standpoint of my tired eyes, the site is presented in little tiny type which can't be increased in size via my browser. Perhaps your eyes/browser will work better. It's definitely worth a read if you are concerned about the impact of Medicare Part D on persons living with HIV/AIDS.

Thursday, January 05, 2006

More on abstinence (only) education

A couple of new articles, one a review article and the other a position paper, in the January 2006 Journal of Adolescent Health tackle abstinence education for adolescents and the harmful effects thereof. While abstinence, as we have said, can be a good thing, there is a human rights issue to be raised when young people, highly at risk for STDs, pregnancy, and predator/exploitive sex, are not only given incomplete information but fed inaccurate information.

From the position paper:


Abstinence from sexual intercourse represents a healthy choice for teenagers, as teenagers face considerable risk to their reproductive health from unintended pregnancy and sexually transmitted infections (STIs) including infection with the human immunodeficiency virus (HIV). Remaining abstinent, at least through high school, is strongly supported by parents and even by adolescents themselves. However, few Americans remain abstinent until marriage, many do not or cannot marry, and most initiate sexual intercourse and other sexual behaviors as adolescents. Abstinence as a behavioral goal is not the same as abstinence-only
education programs. Abstinence from sexual intercourse, while theoretically fully protective, often fails to protect against pregnancy and disease in actual practice because abstinence is not maintained.

There's more where that came from. While the journal site provides abstracts of these articles, the full version in only available for a fee. As it happens, we can send a PDF version of the articles via email upon request: tan AT texasaids DOT net.

New toys!

Busy days, these. Not the least of my efforts has been focused on fiddling with the blog (you are here) and the web site (you can go there).

One new thing that you can see to the right is my shiny new donation button. With some trial and error, I figured out how to get it into the sidebar. Now you can click on it and make a secure donation to Texas AIDS Network. Tell your friends! ;)

The donation site is provided by the National Alliance for Choice in Giving. They will take a 5 percent cut of your donation (charge cards cost those who accept them for payment), and send the rest to us. We'll do good things with it!

The other new thing is a set of calendars for our web site. They can be found through the link to Important Dates. Right now, the calendars include HIV awareness events, office-closed holidays (some of us like to know these things), and election events. The latter are provided because registering to vote and voting matter a lot these days. As the information becomes available, we will also add Texas HIV conferences, Meet the Need campaign events, and anything else that looks like an Important Date.

If you are aware of an event of importance to the Texas HIV/AIDS community, please let us know via email (tan AT texasaids DOT net). We'll post as many of them as we can.

Wednesday, January 04, 2006

FEMA housing deadline extended

Via email:

The FEMA registration deadline for potentially eligible KDHAP [Katrina Disaster Housing Assistance Program] families has been extended from December 31, 2005 to March 11, 2006. The information concerning this deadline in Section 4(b) of Notice PIH 2005-36 is outdated.

This notice extends the deadline for FEMA registration as outlined in the KDHAP operating instructions. More information may be found at http://www.hud.gov/offices/pih/.

Save the date: Women and HIV conference

The Texas/Oklahoma AETC has announced the dates of the Women and HIV International Clinical Conference (formerly known as the Women and HIV Symposium): April 28-29, 2006. The day-and-a-half conference will be held at the Wyndham Dallas North by the Galleria.



This symposium allows providers serving women, including physicians, physician assistants, nurse practitioners, nurses, social workers, and other healthcare professionals to obtain state-of-the-art, evidence-based, multi disciplinary information regarding HIV/AIDS in women.
Information regarding submittal of abstracts is available at http://www.aidseducation.org (look for the conference logo on the right). Additional information about registration and the program will be posted there.

Tuesday, January 03, 2006

Partying like there's a cure

AIDS Healthcare Foundation, everybody's granny in the HIV/AIDS community, tore into Pfizer for its New Year's Eve ads for Viagra. I myself am a wee bit tired of all the ads for all the drugs for ED, most especially when they show up in my email inbox. Even so, I'm thinking that Pfizer is less the problem than the continuing complacency of the general public in the face of HIV and other STDs, which are epidemic in the U.S., not to mention that same public's willingness to abuse prescription drugs.

I checked the AHF web site to see if their original press release were available, since the Reuter's story didn't provide much more information than that AHF didn't like the ads. No joy. However, the Associated Press provided a little more detail. In that story, the phrase "party drug" showed up. This at least got more to the heart of the issue. While AHF's concerns are more strongly presented by AP (and Pfizer's defense equally well presented), the central issue (in my mind) got a little more coverage.

The news story for both news bureaus is, of course, the conflict between two major players in HIV/AIDS, and that's my point. The conflict is less important than the underlying issues, which were never addressed in the Reuter's story and only scantly attended to in the AP story. Pfizer can't be blamed for the unintended purchasers of their product (although I do wish they'd sue the spam marketers to kingdom come), and they are to be commended for adding STD prevention messages to their ads. AHF at least made an effort to raise the real issues. But we still have the twin problems of complacency and drug abuse sitting out there, needing some real attention.

FDA approves generic nevarapine (oral)

News from the FDA:

The Food and Drug Administration (FDA), on December 27, 2005, granted tentative approval, through an expedited procedure, to generic Nevirapine Oral Suspension, 50 mg/5 mL, manufactured by Aurobindo Pharma LTD., of Hyderabad, India. This product is a generic version of the approved product, Viramune Oral Suspension, 50 mg/5 mL, manufactured by Boehringer Ingelheim Pharmaceuticals. It is indicated for use in pediatric patients with HIV.

Nevirapine is active against the human immunodeficiency virus (HIV) that causes AIDS. It is in the class of drugs called nonnucleoside reverse transcriptase inhibitors (NNRTIs), which helps keep the AIDS virus from reproducing. It is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

FDA tentative approval means that although existing patents and/or exclusivity prevent marketing of this product in the U.S., it meets all of FDA's manufacturing quality and clinical safety and efficacy standards required for marketing in the U.S. As with all generic application assessments, FDA conducts an on-site inspection of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to these applications to assess the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.

Tentative approval by FDA means that this product will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).

Anniversaries

The U.S. Food and Drug Administration is celebrating its centennial anniversary this year. To mark this anniversary, the agency has launched a centennial web page that includes several items of interest for the trivia enthusiast. The FDA sponsors health fraud task forces in several states, including Texas; Texas AIDS Network participates in the Texas AIDS Health Fraud Information Network.

Another anniversary coming up this year is the 25th anniversary of (when we recognized) the AIDS epidemic. On June 5, 1981, the CDC published its first official report on the epidemic.

Both occasions matter to the AIDS community. The latter may seem an obvious matter of import, but it is more than a milestone. After 25 years, we've come a long way in our understanding of the disease, its causes, and how to prevent it. Regrettably, we still have neither vaccine nor cure. Worse, we seem to be locked in a time warp when it comes to preventing the further spread of the epidemic. This year would be a good year to knock down some of the barriers to stemming the epidemic. A couple of thoughts on that:

  • AIDS is not a gay disease, but the public still seems to think of HIV in those terms. This affects not only the willingness of individuals to think of themselves in terms of risk but also allows the not-always-hidden homophobia of policy makers to make AIDS funding a grudging priority and AIDS policy a tool for oppression. In 2006, we should address both parts of this mythology. We should reawaken the public to the risks of infection and the needs of those affected at the same time we need to be more open about the harsh impact that homophobia has had on our ability to fight the epidemic.
  • We don't have a cure, and yet the party goes on as if there were a cure. The complacency that has come with the availability of powerful new medications to treat HIV is entirely misplaced. Those medications, as wonderful as they are, are terribly expensive, have harsh side effects, and represent a lifelong commitment to an exacting regimen. We cannot afford to be complacent in either our commitment to preventing the transmission of HIV nor to dealing with the epidemic as it presents itself. That means, I would think, increased efforts to remind the public, especially young people, that prevention is ever so much better than hauling around a trash bag full of pills and listening for the little alarm that says it's time to take more. It would also mean addressing the complacency of donors and funders. Their job is not done as long as we have so many people without insurance, runaway medical costs, and a public safety net that has more holes than net.

No doubt there are more things that we should be talking about and working on for this anniversary "party," but this will surely keep me busy!

As for the FDA's centennial, I do urge you to check out that web site and tickle your trivia fancies. I would also point out that the FDA is an important part of our public safety net, which leads (surprise, surprise) to a couple of thoughts on that subject:

  • We don't have a commissioner. Again. Wouldn't it be nice to have a commissioner who has both the qualifications and the will to focus on the agency's mission?
  • The FDA is not a political plum. Without crossing the line into the politics of Washington, D.C., I think I can still say that we should so not be playing politics with this agency. This is an agency which, like so many other federal agencies, needs to be above the politics of whatever administration is in office and all over the science of the matters that they are dealing with.
  • The FDA is not a chamber of commerce. While I wouldn't think that their job is to get in the way of business, I also don't think that their job is to help business make a profit. The FDA should do its thing in a timely manner, but thoroughly, with public safety as its primary concern.

What we as citizens can do about these issues is far less than we might hope, but there is nonetheless work that can be done. Our congressional representatives need to know that the FDA needs stable leadership with solid professional qualifications and a commitment to mission (not politics). Our congressional representatives also need to know that political interference in the work of the agency is not acceptable. They need to know as well that the FDA can't do its job without adequate staff and funding. And we each should be participating, wherever possible, in the work of the FDA when it touches on HIV/AIDS. Commenting on the proposed rules for condom labels would be a good place to start.

A hundred years, twenty-five years. Time flies, does it not? Texas AIDS Network will celebrate its twentieth anniversary next year. Stay tuned.