New CME on HAART in 2005 from Medscape

Medscape has posted a new medical education module on Highly Active AntiRetroviral Therapy in 2005, with emphasis on changes from the last 18 months:

Changes in the approach to treatment of HIV infection evolve rapidly, fueled by the approval of new antiretroviral agents (ARVs) and new information on how best to use both new and old agents. For over a decade, the International AIDS Society-USA (IAS-USA) and others have recognized the need for expert recommendations to address 4 key questions: (1) When should antiretroviral therapy be started? (2) What regimen(s) should be used for initial therapy? (3) When should therapy be changed? and (4) What should it be changed to? The IAS-USA consensus guidelines are updated as needed, with the last recommendations published in 2004.[1] The purpose of this review is to consider the developments in antiretroviral therapy over the past 18 months and to examine how new data and new agents affect the treatment of patients with HIV infection.

While technical, the article is clear enough for the knowledgeable layperson to understand. Charts and tables augment the text. Some of the conclusions include:

• When should we start therapy? We know that there is a continuum of risk associated with viral replication and immune dysfunction. Although the optimum time for initiating therapy remains elusive, it is clear that treatment should be started before irreversible immune dysfunction occurs. As regimens improve with respect to potency and toxicity, earlier therapy will likely become the rule.
• What should we start with?Not all regimens are equal, and a few are emerging as preferable for initial therapy. Efficacy, toxicity, and long-term strategies remain key considerations in guiding the choice of initial regimens.
• When should therapy be switched?Switching regimens should be considered for virologic failure or toxicity, and toxicity monitoring should be rigorous.
• What should therapy be changed to?Drug resistance testing should be incorporated into routine clinical management, and follow-up regimens should be determined on the basis of expected potency, likelihood of adherence, and toxicity concerns. The concept of structured treatment interruptions has not been validated.

Bristol-Myers, Baylor Plan AIDS Initiative

The Bristol-Myers Squibb pharmaceutical company and Houston's Baylor College of Medicine are teaming up to work on pediatric AIDS in Africa.

Bristol-Myers Squibb Co. and the Baylor College of Medicine are launching a $40 million initiative to treat children with AIDS in the developing world, an effort that includes a "pediatric AID corps" to send doctors to Africa to treat about 80,000 children over the next five years.

Under the plan, BCM will put up $10m for medical student loans; BMS will put up $30m for physician stipends. The news report includes some criticism of the effort and additional news about BMS' intention to not enforce it patents in Africa.

We are almost 25 years into the epidemic--at least as far as we are aware of the epidemic. AIDS was certainly a factor in Africa before we in the West understood the threat. Sadly, it's only in the past five years or so that the world's--and the U.S.'--attention has turned in any productive way to dealing with the issue in Africa. It's very easy, in that context, to think of anything less than total commitment as "too little, too late."

Nevertheless, it is good to see the efforts that BMS is putting forth in Africa. Not enforcing its patents is no small thing. Building 4 clinics is small in terms of the continent's needs, but will make a big difference in the communities that they serve.

While it's also good to see that BCM is devoting some attention to pediatric AIDS in Africa, it would be encouraging to see that more HIV education were included in the curriculum for all of the physicians that it trains. We could still stand to build more AIDS savvy among physicians in Texas.

Press Conference on Prescriptions from Canadian Pharmacy

We received this message from Rep. Hochberg's staff member, Rachel McClure:

Rep. Scott Hochberg and Sen. Rodney Ellis are holding a joint press conference in Houston this Wed. to urge Governor Perry to sign SB 410 which includes the Canadian pharmacy legislation. The Governor has until Sunday, June 19 to sign or veto the legislation.

Please tell your Houston membership about the press conference. It is open to the
public.

In addition, if your organization would like to help or any of your members - please write Governor Perry and urge him to sign the TX Board of Pharmacy sunset bill (SB 410). Send your letters of support to:

Governor Rick Perry
P.O. Box 12428
Austin, TX 78711

Here's the press release:

Hochberg, Ellis to Hold Press Conference on Reducing Costs on Prescription
Drugs
---

(Austin)// Representative Scott Hochberg (D-Houston) and Senator Rodney Ellis (D-Houston) will hold a press conference in Houston on June 8, 2005, at 11 a.m. to urge Governor Perry to sign the Canadian pharmacy legislation. The legislation will allow the Texas Board of Pharmacy to inspect Canadian pharmacies so that Texans will have safe options for less expensive prescription drugs.

Last month, Representative Hochberg amended SB 410 to establish a program that allows the Texas State Board of Pharmacy to inspect Canadian pharmacies which can later sell and ship prescription drugs directly to Texans once they pass inspection.
Participating Canadian pharmacies would be required to meet the same safety standard as any other pharmacy operating in Texas. Texans consumers would only be allowed to utilize a participating Canadian pharmacy for refill prescriptions.

The amendment was similar to legislation, HB 173 and SB 518, filed by Hochberg and Ellis. The plan is modeled after successful programs in Minnesota and Wisconsin. Illinois, New Hampshire, North Dakota, Rhode Island and Vermont also have programs to help residents obtain less expensive prescription drugs from Canada.

WHAT: Reducing Cost of Prescription Drugs Press Conference

WHO: Representative Scott Hochberg
Senator Rodney Ellis

WHEN: Wednesday, June 8, 2005, 11a.m.

WHERE: Seven Acres Jewish Senior Care Service
6200 North Braeswood
Houston, Texas 77074

(take Hwy 59 South, Beechnut exit, near Memorial Hospital-Southwest)

Here's our earlier post on the subject: Licensing Canadian Pharmacies in Texas.

Hinky marketing of immune boosters

As you may realize from all the references to the Texas AIDS Health Fraud Information Network, Texas AIDS Network is concerned about the fraudulent marketing of useless products to a vulnerable population. As long as treatment for HIV is so expensive and access to that treatment is so limited, there will always be a market for this false hope.

Periodically, I do a test of the Network's website listing in various search engines. I enter assorted key words that I hope that we are associated with and then click "Go" to see whether we show up and how high we rank.

A recent test of our listing for the Yahoo search engine brought some interesting results.

The key words that I used were: Texas, HIV, medications. The Network ranked second after the Texas HIV Medication Program. Pretty good, I'm thinking. But, ever curious, I looked on down the page to see what else might be there. I was surprised to see another site that directly quoted from our website. I had to check it out.

This new page looked like a list of helpful links for HIV medications and just included a link to Texas AIDS Network with a site description lifted from our Access section. This could be a good thing. Links from other sites help bring traffic to the Network's site. The more links, the better our ranking in search engines.

On the other hand, the address for this page included an apparent product name. When that happens, I pretty much go on red alert. It didn't make my alarm bells quit ringing when I saw that the ad at the top of the page was for an immune system product which was also headed as: "Our Top hiv medications Resource." (The punctuation alone was enough to set my teeth on edge, but that's another story.)

Still, I gamely clicked "here" as directed. "Here" was a cornucopia of red flags for anyone who looks out for health fraud, not the least of which was the claim that a dietary supplement is "effective in the fight against" a whole host of diseases including HIV and just about everything but zits.

That was enough to lead me to try to track down the company--which turns out to be located somewhere in the U.S.--and make a report of a questionable product to TAHFIN. (The federal representatives on the task force handle non-Texas reports; the state representatives handle Texas for us. It takes international treaties to do anything about websites that market from other countries. It's possible, but harder.)

None of this is to say that this product is not a totally wonderful thing nor to say that anyone who takes it may not suddenly find themselves able to leap tall buildings. It is to say that making claims to "help in the fight against HIV/AIDS" needs to be backed up by some credible scientific research, which I didn't find. It is also to say that this kind of marketing, which implies endorsement by legitimate organizations, is pretty hinky. (Yes, I learned that word from watching NCIS.)

If you are concerned about a product that you find marketed on the Internet, you, too, can contact TAHFIN to find out whether the product is legitimate. What you will likely be told is only whether the manufacturer is in compliance with the law, but that is a good first step in determining legitimacy. Effectiveness is a whole 'nother question (that's what the scientific research is supposed to be for).

UPDATE: Hmmm. Anybody can sue about anything these days. I removed the product references just to make this a more generic statement, which it is intended to be anyway. I hope that didn't make it vaguer at the same time it made it more generic. [sigh]

FDA approves generic foscarnet

We received this notice from the U.S. Food and Drug Administration:

FDA issued an approval on May 31, 2005 for a generic formulation of foscarnet sodium injection, 24 mg/mL, 250 mL and 500 mL single-dose containers, manufactured by Pharmaforce, Inc., of Columbus, Ohio. The product is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS), making a generic alternative formulation available in the United States.

The product is a generic version of Foscavir (foscarnet sodium Injection) 24 mg/mL, 250 mL and 500 mL single-dose containers, manufactured by Astra Zeneca, originally approved in 1991.

Foscarnet/Foscavir is not currently on the formulary for the Texas HIV Medication Program.

Join the Caravan to End AIDS

C2EA--the Caravan to End AIDS--calls for action:

Join the Campaign to End AIDS (C2EA)! An exciting new coalition of people living with HIV/AIDS, our advocates, organizations, and coalitions, united in action with our allies to chart a new course towards an end to the AIDS pandemic.

This summer, we are calling on people living with HIV/AIDS and organizations that serve them. We are mobilizing the veterans of the AIDS movement and a new generation of fighters. We are raising the stakes by organizing ten caravans of AIDS activists to travel through all 50 states in America this fall. We will stop in cities and towns along the way to meet people fighting this disease. Together, we will draft a Road Map to End AIDS, learned from the hard won lessons of two and a half decades of survival. And in October, these caravans will converge in Washington DC for five days of action and a March to End AIDS.

Start your summer by joining us in this concerted mobilization of the AIDS movement. Go to www.EndAIDSNow.ORG and register.

Once you sign-on, you will receive information on how to:

• Become a rider on a caravan or help organize the route coming through your state.
• Organize local welcome committees and media events.
• Participate in fundraising efforts and attend local fundraising shindigs.
• Connect with like-minded people from around the country and sharpen your media, fundraising, and organizing skills.

We have the tools to end the AIDS pandemic, Let's use them!Visit www.EndAIDSNow.Org and register TODAY.

On Memorial Day, we have many brave souls to thank and remember. In the AIDS epidemic, there are also many to remember. Texas AIDS Network has a banner that we sometimes trot out for events. It says "Texas Remembers, Texas Responds." Remembrance is important. So is responding. C2EA looks like a good way to respond.

Coburn on Condoms

Sen. James Coburn (R-OK) apparently gives a regular lecture for young folks who work or intern at the U.S. capitol--and all around Oklahoma, too--about STD's. The Washington Post has a lively article about the most recent lecture along with some feedback/commentary by Bill Smith, vice president of the Sexuality Information and Education Council of the United States. The lecture included some ghastly pictures of untreated STD's as well as some telling questions and answers.

The Senator, who is both politically and religiously conservative and who has frequently weighed in on AIDS-related federal policy, also talked about condoms.

During his 40-minute slideshow, Coburn avoided any spiritual overtones and spoke in his usual brisk clinical way. Still, Smith detected bias, taking issue, for example, with Coburn's contention that condoms are only 69 percent effective in preventing HIV; Smith says the latest studies show condoms to be 99 percent effective.

But Smith did give Coburn credit for saying during the question-and-answer portion, "Condoms do reduce the risk of transmission, and they work very well against HIV. If you decide to do any risky sexual behavior, use a condom."

That's the money quote, so to speak. We may as well ignore the apparent contradiction between his lecture and his answers to questions; it might be fun to be a bit snarky about it, but there's not much benefit there. Instead, we should all make a fast note that Coburn is quoted, as highlighted above, by Hanna Rosin in The Washington Post, May 27, 2005, page C01. The subject will come up again--and that quote will be most useful.

Five Questions: The Second Question

Tackling the second question second, the question is:

2) What degree do you hold and what other jobs have you held before your job with Texas AIDS Network?

After answering the fifth question, you might be able to guess a bit about my education. I really, really wanted to be an astronomer when I was finishing high school and getting ready for college. That's because I figured that an astronomer would be needed to help navigate when we started exploring beyond the solar system, and I wanted a spot on the ship.

As it turns out, I was better prepared in English than in math and science, so I ended up majoring in English for my first degree. I did some graduate work in English, but I was still looking for those long voyages beyond my boundaries anyway, so I eventually switched my major to Anthropology. I completed both a Master of Arts and a Doctor of Philosophy in that field.

Jobs. Not so many. Teacher. Researcher. Association executive. I taught Swahili. I did research in Swahili. I was ED for a nursing association (although I am not a nurse).

The answer to your question should reveal my qualifications--or at least my interest--in HIV as a prelude to becoming Executive Director of Texas AIDS Network. Since I seem not to have done that, I'll tackle the answer in a slightly different way.

Texas AIDS Network focuses at the moment on access to HIV medications. We may--and have--shift our focus to prevention issues or service issues or other things as time and resources permit. But right now, our major concern is how to get medications to Texans living with HIV/AIDS.

As part of our focus we do research on the system that provides access to medications. We look at public systems, we look at private systems. My research skills are what come in handy here. We also conduct educational activities. We present seminars and workshops, conference presentations. We develop learning tools for clients and providers. My years of teaching come in handy here. We also look at where the system--that we have studied and talked about in educational forums--needs to be improved or better funded. That involves advocacy, both in terms of providing information to the community about the issues that we have discovered and going directly to policy makers to seek those changes.

As it happens, nothing in my academic background prepared me for the advocacy component. I picked up that skill set when my neighborhood was threatened by a development that we didn't want. From there came coalition building, appointment to an advisory board, and running a political campaign. These were all volunteer positions, but they gave me a lot of experience from several angles for working on policy.

As for HIV, there is both a personal and an intellectual component to my coming to this job. On one of those last trips to Africa, sort of my last stand as an anthropologist, there was already evidence that something terrible was happening. As a friend in Catholic Relief Services said: "The bodies were stacked up like cordwood in the morgue." Working with the nurses association (my first shot at an actual policy job), I first learned about AIDS and the connection with what I had heard about while in Africa. And then I lost two family members to the epidemic.

When this job came along I was ready. I had the motive and the means; all I needed was the opportunity to try to make a difference. Texas AIDS Network gave me that opportunity.

Five Questions: The Fifth Question

Taking the questions out of order, I'll start with the last question:

5) Do you have any advice for young people like me who are embarking on careers in Public Health?

I've spent a fair amount of time thinking about this one. It would be easy to try for some flippant response like: Have you considered a career in law instead? But there is a crying need for more public health professionals in our country. I don't just mean nurses and physicians and what not. I mean people who are trained to look at health in terms of the whole community. These folks are often emplyed by the government at various levels and, therefore, will by definition be low-paid. They could probably make more money as nurses.

But health is not simply a matter of how I or you are feeling today. It's also about whether we are part of a group of people who are feeling the same way for the same reasons. It's about discovering those reasons and looking for solutions. It's about helping to shape health policies and carrying them out. It's about making our communities healthier, safer, better places to live.

My advice? I suppose there are any number of things that I might recommend, but the one thing that I think I would strongly encourage is that you add a second language to your toolkit.

By this I mean become fluent in another language, not just take a couple of years of college classes.

We are a nation of immigrants. Like it or not, immigration--perhaps legal, perhaps not--will increase in the coming years. Many of our nation's residents do not speak English as their first language. Learning the language of the community that you will be working with will give you extra tools to do your job.

How?

The first thing is what I as a former language teacher (more on this later) particularly liked. By learning a second language you will learn more about your own language and become more skilled in using it. Not that that will help you in public health, but it will make your old English teacher happy.

The second, and more important, is that knowing the language of the community that you will be working with will help give you entre. You will be less "other" and more easily accepted as someone who can be listened to.

The third, and most important, is that knowing the language of the community will allow you to hear more clearly what they are telling you about their problems because they will be more comfortable and articulate in speaking about those problems. The burden of understanding will be placed, of course, on your shoulders but the people you are working with will be able to concentrate on what they want to tell you and not how to tell it.

A fourth thing that is important, but I won't rank it, is that with the language will come some better understanding of the culture in which the language is spoken. This matters. We tend to think of health as a medical issue that is itself all about science. But health is also a cultural concept. What is meant by good health, what is considered to be a healthy practice--these are all influenced by the culture in which we are raised. It's a good thing to recognize, even if we don't know the specific differences between one culture and another, that there are likely to be differences in surprising places. Language can sometimes signal those differences.

I don't work directly with clients on most days, but I can tell you that it was very powerful to attend a hearing on a rule change this summer and see the Commissioner of Health be able to understand a woman's testimony when she spoke in her native language. She first attempted to speak in English, but she was clearly struggling--and most embarassed. The Commissioner allowed her extra time to speak and asked her to speak in Spanish. I had no clue what she was saying (although I--and the Commissioner--already knew her point), but she was so clearly pleased to be able to say her piece then and did so with what appeared to be both skill and passion.

So which language? Depends on the general area where you think you might work. Spanish seems like a good starting place, but Vietnamese or some other language might be used in the area where you end up working. Indeed, you may end up with more than two languages in your toolkit over a lifetime.

My recommendation, after some preliminary classwork, is to just immerse yourself in the language. Read the newspaper, listen to the radio, make some friends. You'll never be a native speaker of the second language, but any progress that you make in learning will pay off with big dividends later on, I think.

If nothing else, certainly learn the basic greetings and courtesies of the language.

Five Questions

Brad Biggers over at AIDS Combat Zone took the five question challenge and then tossed it to his readers. I offered to take up the challenge, and he has sent me my five questions.

1. What do you see as today's biggest barrier to helping people living with HIV/AIDS in Texas?
2. What degree do you hold and what other jobs have you held before your job with Texas AIDS Network?
3. Imagine you're given $1,000,000 and told you can only use it to increase funding of one AIDS-related service in Texas, what would it be? (e.g. expanding free testing, outreach to a specific group, ADAP, etc.)
4. To steal a question from Terrance, If you weren’t doing what you’re doing now in regards to work, what else would you choose if there were no limitations on your choices?
5. Do you have any advice for young people like me who are embarking on careers in Public Health?

These are some pretty tough questions, so I'll be taking my time in answering them. After all, if I offer that advice, someone might take it--so it had better be good!

Thanks to Brad for offering this challenge. It's already provoking some serious thought.

Texas HIV Appropriations

At this point, the appropriations bill is in Conference Committee. Even though both the House and the Senate have recommended that $15 million in new funding be appropriated for HIV, there is still the odd chance that the committee might decide to take that money to pay for something else. We (Texas AIDS Network and allies) have been keeping a close watch on the situation, just in case we needed to take some sort of additional action.

For the time being, we're thinking that it's best to let sleeping dogs lie.

Why? First, we know that there are some strong allies for HIV on the committee. Senator Zaffirini is practically a one-woman army, and she has a lot of help in unexpected quarters. Second, we spent some time at the capitol on Monday "taking pulses" and checking for indicators that there might be any trouble on the horizon for HIV. What we found was pretty much comforting--no indicators of trouble.

This doesn't mean that we don't have to maintain vigilance, but it does mean that, as the session moves into its final month, there is more reason to be cautiously optimistic that the Texas HIV Medication Program will have the funding that it needs to operate in the coming biennium without cutting services.

I'm back (again)

This is starting to get a little old, I think. We have lost four family members since Christmas (five if you count the cat), and I've just returned from the funeral for a beloved uncle. Let's all hope that this is the last one.

I will be playing catch up yet again. There is, however, much in the Good News Department, so stay tuned.

Barriers to Care

Bob LaMendola writes for the South Florida Sun-Sentinel regarding barriers to care for HIV-positive black women in the region. The list of barriers pretty much fits everyone else everywhere else, no?

The stigma: Many women avoided doctors, public clinics and programs because they didn't want family or friends to know they were infected.

Red tape: HIV/AIDS programs often require long and intrusive forms, and send women from office to office to get services. Many women had no idea where, in a jumble of agencies, to find help.

. . .

Putting family first: Some women reported having no time for medical care because they were too busy earning money and taking care of their families.

Denial: Some women insisted they were misdiagnosed or felt fine.

Misconceptions and mistrust: Some thought that being infected meant they were only carriers, not sick. Others, including many Caribbean immigrants, rely solely on folk remedies or religion.

Inadequate access: Hurdles to health care include a scarcity of local doctors, long waits at clinics and a lack of public transportation and day care.

Lax followup: Doctors, clinics and emergency rooms struggle to make sure patients keep taking medicine. No agency takes charge.

Giving up: Some infected drug users and prostitutes don't bother seeking treatment because they are ashamed about their history. Others assume HIV equals death.

. . .

Other obstacles found by the study: Some programs do not provide care unless patients are drug free, some patients suffer debilitating side effects from meds and some report disrespectful treatment by assistants at clinics and doctors'
offices.

Some of these barriers can be torn down with more intensive education of both clients and providers. Building some trust would help out a bit, too. But the red tape and the clear evidence of lack of funding needs more attention at the higher levels of planning and policy. We could stand some of that in Texas, too, I'd say.

Crystal Meth-->Hypersexuality-->HIV

Uh huh.

HIV and Viacom

Viacom is in the midst of a three-year program in partnership with the Kaiser Family Foundation to increase HIV awareness through Viacom's various media outlets, including: CBS and UPN; cable networks MTV, BET, VH1, CMT: Country Music Television, TV Land, Nick at Nite, Showtime, Spike TV and Comedy Central; and 183 Infinity Broadcasting radio stations in the top 50 markets. An Associated Press report published on ABCnews (a Disney outlet), says:

. . . Kelli Lawson, executive vice president of corporate marketing for BET, says Viacom's outreach efforts are effecting change.

In a survey of blacks conducted by Kaiser last August, among 18-to-24-year-olds exposed to Viacom's campaign, half said they had discussed safe sex practices with their partner because of the Viacom campaign.

And nearly 77 percent of that group who were sexually active said they were more likely to use a condom because of the campaign.

Maybe Disney will now take up the challenge?

Spongeworthy

Contraceptive Sponge to Return to Market

Linda A. Johnson, writing for the Associated Press, reports that the contraceptive sponge is about to return to the U.S. market after a ten-year hiatus. The sponge is one of the older forms of birth control used by women and, while not as effective as some other means now available, preferred by many because of comfort and convenience.

While this would be good news for many women, a word of caution applies: This device will not prevent the transmission of sexually transmitted diseases.

Waiting Lists for ADAPs

Perhaps I spoke too soon when I complained about the trickle of "new news" regarding HIV and AIDS in the U.S. Reuters has a story out today about the waiting lists for some state ADAP programs thanks to a new study (PDF) released by the Kaiser Family Foundation. The Reuters report is, however, much truncated from the much more informative press release issued by the Foundation about the study.

Texas is shown in the report as providing "all approved ARV's in all four drug classes, NRTIs, NNRTIs, PIs, and Fuseon Inhibitor" but "[less than] 10 'AI' drugs recommended for the prevention of OIs." The PowerPoint presentation for the report does not show that Texas has a waiting list for the Fuseon Inhibitor, and that number (now about 36) is not apparently included in the total number of persons counted as being on waiting lists for ADAPs. Texas is listed as one of the states with cost containment measures in place and anticipation of additional measures needed in FY 2005.

KFF also provides a brief fact sheet (PDF) on the issue (with some clue about all those acronyms I threw out above).

Catching up on some links

Blogger is giving me fits today, but I will make a stab at getting another post out. [crossing fingers]

Here are some links that may be helpful in getting a broader perspective on HIV/AIDS issues:

Texas AIDS Health Fraud Information Network--This is a task force that Texas AIDS Network has participated in since 1982. Indeed, Texas AIDS Network helped found it. The task force provides information for consumers and providers regarding fraudulent treatments, devices, and information related to HIV/AIDS. The web site includes news, fact sheets, downloadable brochures, and tips on what to look for when considering alternative and complementary therapies. There's no agenda to discourage CAM, just some help for the cautious consumer, because there are some products that are harmful to people living with HIV and, of course, some outright fraud. There are, by the way, similar task forces in other states.

AIDS Combat Zone--Brad Biggers left a nice comment and then linked to Texas AIDS Blog. After visiting his site, I see that there is a nice round up of news stories there, many of which we don't cover here, e.g., international news, since our focus is pretty much limited to Texas and things that matter to Texans living with HIV (at least, we hope so!). Brad's done a lot of work on his site to gather useful reference links.

Respectful of Otters--This one is an old favorite. When someone gives their tagline as--"I'm a psychologist working in HIV research and treatment in the inner city. Don't talk to me about 'compassionate conservatism'"--I have to look twice. Ms. "Otter," who has just given birth to a new "Otter pup" named Alexandra (congratulations!), writes on an eclectic mix of health issues and Canadian and U.S. politics. There are occasional HIV-related stories on her site, but you do have to hunt for them. The title, by the way, comes from a student typo: "Psychologists have a duty to be fair and respectful of otters." Somehow I think we all share that duty. ;)

Oy!

Expensive drugs, sick patients, bribery--not a good mix. Even worse that it comes along at the same time that there are investigations of embezzlement at a Florida ASO.

I hope that's the end of it.

Scanning the news for stories about AIDS brings mostly stories about the epidemic overseas. There are occasional stories that pop up about a large fundraiser somewhere. Sometimes there's a press story about the allocation of Ryan White funds in a particular area. Of course, there is a slow but steady stream of reports about this or that stage in the progress of drug research.

AIDS is, however, mostly old news in the U.S. It takes a scandal of some sort to really get press attention. The Florida story has been showing up for several days now in various news reports. Then along comes the Serono story. All we need is for enterprising reporters to start looking for more dirt to lose what little focus there is on the needs of people living with HIV and AIDS in this country.

If that sounds like I'm missing the point that both of these stories are about criminal behavior, I'm not. But I'm just as upset about the fact that these folks had to practice their criminal behavior on AIDS. If they had been bribing docs to prescribe some cancer medication or embezzling funds from a diabetes organization, the impact on patients would be less hurtful.

HIV is already a "scandalous" disease. Anytime we go to the Texas Legislature to ask for more funds for HIV, there's always some legislator who wants to bring up "responsibility." There was a bit of a struggle in the Senate Finance Committee that included a hint of that issue. We have made it (so far so good) through both the House and the Senate now with our request for $15 million in new funds for HIV--and only have to watch out for the Conference Committee and the Governor's line item veto. We don't need any additional stories to feed the "scandal beast" and give anyone any ideas about cutting that funding.

So, I'm just saying, I hope that's the end of it.

HPV Vaccine

Via Atrios and The Light of Reason.

I am apparently a bit behind on this news: GlaxoSmithKline and Merck have both developed new vaccines to prevent human papilloma virus, a cause of cervical cancer, which in turn is a significant risk for women with HIV. Earlier reports on these vaccines were available last November. Current reports are now addressing some of the difficulties of getting social acceptance of the vaccines and of licensure for production in other countries.

Tell me again why a parent would put a child in a car without a seatbelt?

Nonoxynol-9 Warning Labels--Not Yet

The Government Accountability Office (GAO) has released a new report about nonoxynol-9 (N-9) and the prevention of HIV: HHS: Efforts to Research and Inform the Public about Nonoxynol-9 and HIV (March 2005). The report's Concluding Observations are:

CDC’s and NIH’s efforts to research N-9’s potential use as a microbicide ended in 2000, when the preliminary results of a major clinical trial indicated that N-9 may actually increase the risk of contracting HIV. CDC has warned that N-9 may increase the risk of HIV transmission when used frequently, and some manufacturers of N-9 condoms have taken steps to either add their own warning labels or remove their N-9 condoms from the market, while other manufacturers have not taken such steps. FDA has proposed requiring new warning labels that indicate that N-9 vaginal contraceptive products do not protect against HIV or other STDs and that frequent use, such as more than once a day, may increase the risk of contracting HIV. FDA is also developing proposed warning labels for N-9 condoms. While FDA expects to issue the final rule for the new warning labels for vaginal contraceptive products by September 2005, it has not yet issued proposed warning labels for N-9 condoms, and it has not indicated a target date to issue the final warning labels for N-9 condoms. Since FDA is still in the process of completing warning label changes for N-9 vaginal contraceptive products and condoms, the public may be left in doubt about the appropriate uses of these products until FDA finalizes these warnings. Further, the public may be at risk if the products are used inappropriately.

There are any number of snarky comments that come to mind in response to this report, but I will forego them in order to point out that there needs to be a tad more haste in the slow progress of government processes when it comes to warning labels. My recollection is that repeated use of N-9 irritates mucous membranes and makes it easier for the virus to enter the bloodstream. Even if my recollection is off in terms of the exact problem, I'm still thinking we heard all of this several years ago. If folks are using out of date information for prevention messages ("Use latex condoms with N-9" used to be the recommendation), the delay in providing warning labels is inexcusable.

Disinformation.gov

The American Prospect's online article is captioned "Misleading.gov," but there may be a more proactive element to the inaccuracy of information that is now being published on the new website being promoted by the U.S. Department of Health and Human Services--www.4parents.gov--which is why I'm going with disinformation. TAP does a nice job of pointing out some of the inaccuracies and gaps in information regarding condoms that are published on the site as well as pointing out some of the consequences of those inaccuracies.

So here's a thought. Seatbelts neither promote nor prevent accidents. They just protect you when you have one. Why wouldn't you tell your kids to wear their seatbelts when they get in a car?

The War on Condoms continues apace.

I'm Back

My father-in-law passed away last week, and we spent most of the week making arrangements and traveling to the funeral. I will be catching up on blog posts as rapidly as I can.

Licensing Canadian Pharmacies in Texas

HB 173, by Rep. Scott Hochberg (and the companion SB 518 by Sen. Rodney Ellis) has been on my list of "troubling" bills for some time. The bill is captioned as: "relating to the licensing and regulation of Canadian pharmacies for the dispensing of prescription drugs in this state." When I first saw the caption, I immediately thought that this was a reimportation bill. The original press release that accompanied its filing didn't do much to change my thinking (the press release for SB 518 is a little clearer) .

Still, the bill is one that we would ordinarily watch as it goes through the process and not do anything about. However, that changed when Rep. Hochberg's office called Texas AIDS Network and asked for an endorsement. We had to "get down" and do some serious discussions about the bill's intent and what it might do for people with HIV/AIDS in Texas.

So here's the deal.

Prescription medications are expensive, even if you're only dealing with allergies. If you have a chronic disease or multiply diagnoses and need a combination of medications to treat your illness (gee, just like HIV), the cost can get out of hand pretty rapidly. If you do not have insurance and do not qualify for any of the pitifully few public safety net programs, you have to dig into your own pocket for $12-15,000 worth of medications each year. Or wait until you get sick enough to lose your job and then qualify for the public safety net.

One of the alternatives to waiting out the disease and/or going broke paying for medications in the U.S. is to look across our national borders for cheaper alternatives. This has not always been a good idea. There's your questionable manufacturing practices. There's your shady pharmacies. There's your outright fraud and substitution of fake ingredients for the real thing.

Still, the possibility of getting cheaper medications from Canada specifically has gotten a lot of attention in the last few years. (Canada has a single payer system of health care and has negotiated lower prices for medications used throughout their system.) Now the idea has come to Texas.

Texas AIDS Network bases it advocacy on a set of policy principles. A couple of those principles come into play on this bill:

• 13: Persons with HIV infection should have access to FDA-approved, effective drug treatments.
• 14: Persons with HIV infection should have accurate information about quality medical and health treatments available to combat HIV-related illnesses. Fraudulent treatments should be aggressively pursued by legal authorities.

The Network was a founding member of the Texas AIDS Health Fraud Information Network. Since the FDA has been a sponsor of that group, we have long been exposed to (and shared) the FDA's concerns about fraudulent treatments, the risks of reimportation, and the gaps in FDA's resources to deal with either of these.

Rep. Hochberg's office is now looking at the bill, not as an invitation for consumers to buy their medications from Canada, but as a means to protect consumers who choose to do so from potential fraud. The bill allows real "brick and mortar" Canadian pharmacies to apply to the Texas Board of Pharmacy for licensure in Texas. These pharmacies would have to meet all Canadian licensure requirements before applying for Texas licensure; they would be subject to inspection by the Texas Board. (This would eliminate some of the risks associated with internet pharmacy orders and the apparent abundance of fake Canadian pharmacies now advertising via spam.)

The bill says that the pharmacies would apply to dispense specific medications, meaning that they would have to name the medication and its price for the Texas Board. The medications would have to be "equivalent" to U.S. FDA approved medication. The Texas Board would then maintain a website that provides information about approved pharmacies, their prices, and how to order.

As a bill designed to protect the public safety, we have endorsed the bill. As a matter of public policy regarding patient access to medications, we prefer a stronger public safety net.

Worth following up

[Reminding self to do so]

As I may have mentioned, I'm using a new service called GovTrack to feed me information about Congressional actions. It's not terribly timely; there's usually some delay between action and notice of an action--and even more delay before the details are accessible on the web. Still, it's been pretty much of an eye-opener, as in the case of S. 288, State High Risk Pool Funding Extension Act of 2005. This bill was reported out (passed) by the Senate Committee on Health, Education, Labor, and Pensions on February 10, 2005 (well, I did say there was some delay in getting information!).

According to the committee summary:

S. 288 would amend the Public Health Service Act to extend the funding for the creation andoperation of a state high-risk health insurance pool. The high-risk pools offer health insurance to individuals who cannot obtain coverage in the marketplace. Under an authorization that expired in 2004, the Department of Health and Human Services (HHS) provided seed grants to states to create a high-risk health insurance pool and operational grants for the losses incurred in connection with the operation of a pool. S. 288 would extend the funding for the seed grants through 2006 and would increase and extend the funding for the operational grants through 2009. In addition, the bill would alter how grants are allotted to states.

The summary provides a few more details about the changes in how grants are allotted to states:

S. 288 would eliminate both the original requirement that each state match the amount of the federal grant to defray the cost of operating a high-risk pool and the corresponding limit on the federal contribution to no more than half of the operating loss of the pool. The bill would require that a portion of the funds for operational grants be used for grants to provide supplemental benefits, such as premium subsidies for low-income individuals, a reduction in premiums or other cost-sharing requirements, an expansion or broadening of the pool of individuals eligible for coverage, or increased benefits to enrollees or potential enrollees in a qualified high-risk pool. However, on June 30 of each fiscal year, unspent funds allocated to grants for supplemental benefits would be distributed to the states receiving operational grants that cover incurred losses. [emphasis added]

The bill also would modify the formula for allocating funds to states to give half of the funds to eligible states equally and apportion the other half based on the number of uninsured individuals in each state and the number of enrollees in the state's qualified high-risk pool. Previously, all funds were allotted based solely on the number of uninsured individuals in the state. Based on the operating losses of the existing pools (in 31 states), CBO expects that all of the appropriated funds would be spent, with direct spending of $14 million in 2005 and $355 million over the 2005-2010 period.

I'm not quite sure how this plays out for Texas. The Texas High Risk Pool has been operational for several years and is quite expensive, more so as individual risks are calculated. The program was not intended to help low income individuals. If, however, Texas is eligible for these grants--and our high rate of uninsured residents should put us in the ballpark--it would be interesting to know whether any accommodation will be made for low income persons as a result of the grants.

Sex and the Course of HIV Infection in the Pre- and Highly Active Antiretroviral Therapy Eras

Medscape reprints an article by Maria Prins, Laurence Meyer, and Nancy A. Hessol, which was first published in the March 4 issue of AIDS. Here's the abstract:

We reviewed the available literature on the potential effects of sex on the course of HIV infection and found that there is little evidence for sex differences in the rate of disease progression in the pre-highly active antiretroviral therapy (HAART) and HAART era. Compared to men, women appeared to have lower HIV RNA levels and higher CD4 cell counts shortly after infection with HIV, but studies were inconclusive regarding whether these differences diminish over time. Differences in viral load or CD4+ cell count might cause women to delay initiation of HAART. Nonetheless, we found no substantial sex difference in the benefit of antiretroviral therapy. The studies we reviewed failed to find any harmful effect of pregnancy on HIV disease progression. With the availability of effective antiretroviral agents, HIV-infected women have increasingly decided to have children. Conflicting results exist on the effect of HAART on regression of cervical intra-epithelial neoplasia (CIN). Unlike CIN, invasive cervical cancer has not been found to be much higher in HIV-infected women than in HIV-uninfected women. Although publication bias cannot be ruled out, published studies suggest higher rates of adverse events among HIV-infected women on therapy as compared to men. As more pharmacological agents are developed, it is especially important that potential sex differences in pharmacodynamics are assessed. The relationship between metabolic abnormalities, changes in body habitus, and endocrine perturbations has not been extensively studied. Whether sex differences are due to unalterable genetic factors or social and environmental conditions, it is imperative that all HIV-infected individuals have equal access to interventions that can slow disease progression.

So far so good in the House

The House Appropriations Committee has voted unanimously to substitute its version of the appropriations bill (HB 1) for the Senate version of the appropriations bill (SB 1). Now SB 1 will go to the full House of Representatives for discussion and vote.

The good news is that the House version of the appropriations bill is exactly the same as the Senate version when it comes to funding for HIV. The $15 million exceptional item request made by the Texas Department of State Health Services has been approved--so far.

The next step is the House vote. Then comes a conference committee to iron out the differences between the House version and the Senate version. This is where the bad news comes in. Even if both houses say that the $15 million should be appropriated, the conference committee can still take it away to pay for something else.

Texas AIDS Network is gearing up for a campaign to help the conference committee do the right thing. If you want to be part of that, drop us an email: tan AT texasaids DOT net. To participate, you'll have to commit to getting at least 19 other folks to send postcards to all 10 conference committee members. We'll provide the postcards, but you and your posse will have to pay your postage.

Update: The House is expected to start considering SB 1 on Wednesday, April 6.

Updated Pediatric Guidelines

The Office of Special Health Services for the FDA sends the following information:

The Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection have been updated, March 24, 2005. Please note that the Appendix, Characteristics of Available Antiretroviral Drugs, has been extensively modified to include up-to-date drug information, including updated information about pediatric dosing and new drug formulations. The updated Appendix also includes a matrix based on Table 18 in the Adult Guidelines (adverse drug reactions) and three matrices based on Tables 19-21 in the Adult Guidelines (drug interactions between antiretrovirals and other drugs).

The Pediatric Guidelines are developed by the Working Group on Antiretroviral Therapy and Medical Management of HIV-Infected Children, which reviews new data on an ongoing basis and provides regular updates to the guidelines.

The updated guidelines document is available in the Pediatric Guidelines section of the Guidelines page on the AIDSinfo Web site.

The AIDSinfo website is also a valuable source of other information related to HIV/AIDS, including other treatment and prevention guidelines, downloadable databases for PDAs (Personal Digital Assistants), and HIV/AIDS-related clinical trials information.

Legislature at Half-way Point

We have passed the 70th day of the 79th regular session, marking the end the first half of the session. So far:

• 3484 bills and 1072 resolutions were filed in the House. Because of the 60 day rule, relatively few additional bills would be expected for the remainder of the session.
• Of the House bills filed in the first half, 192 received favorable committee votes and 27 of those were then passed by the House.
• 1787 bills and 500 resolutions were filed in the Senate in the first half.
• Of the Senate bills, 152 received favorable committee votes and 45 of those were passed by the Senate.
• Only 1 joint resolution was approved by its originating chamber during the first half.
• No bills or joint resolutions have yet been approved by both houses. 43 concurrent resolutions, all ceremonial in nature, passed both houses in the first half and 35 of those were signed by the governor.

Bills passed by the Senate must also be passed by the House (and vice versa) before they are sent to the Governor for his signature or veto. We're half-way through it all, but there is still a long way to go.

Medicaid Estate Recovery

The Texas Health and Human Services Commission has sent the following notice"

In compliance with federal law, Texas has implemented the Medicaid Estate Recovery Program. With this program, the state may file a claim against the estate of a deceased Medicaid recipient, age 55 or older, who applied for certain long-term care services on or after the program's effective date, March 1, 2005.

Officials with the Department of Aging and Disability Services, which manages the program in Texas, say claims will not be filed when:

• There is a surviving spouse.
• There is a surviving child or children under 21 years of age.
• There is a surviving child or children of any age who are blind or
  permanently and totally disabled under Social Security requirements.
• There is an unmarried adult child residing continuously in the Medicaid recipient's homestead for at least one year before the time of the Medicaid recipient's death.
  

[Website information]

HB 43 Hearing

The hearing broadcast begins at 1:31:25 on the first session archived for March 22. It continues for about 15 minutes at the beginning of the second session archived for the day.

SB 127 -- Disease Control Programs

Disease control, harm reduction, needle exchange--we've seen this issue every session since I've been working for Texas AIDS Network. Some really fine folks have carried these bills in both the House and the Senate. Very often, the bills have died in committee, especially in the House. The Senate has been a little more collegial, allowing bills to be voted out of committee, but then they mysteriously never seem to get to the floor for debate and vote.

SB 127 was heard in the Senate Health and Human Services Committee yesterday afternoon. Several folks testified in support of the bill. No one spoke against it. Senator Jane Nelson chaired the hearing and was quite engaged in the issue. She asked several pertinent questions and seemed to have an honest interest in trying to figure out a way to support the bill. Her biggest concern was not the "moral" issue of needle exchange but the "message" issue, i.e., her concern that supporting needle exchange would send the wrong message to our youth with the apparent implication being that drug use is okay because we are giving needles to addicts and allowing them to continue to break the law by using illegal drugs. Or something like that.

Chairman Nelson was about to leave the bill pending in committee, since a quorum was not present, when several Senators began trickling in through various doors of the chamber. Senator Lindsay had marshalled his votes--and the bill passed.

The next challenge is to get the bill to the Senate floor for a vote.

HB 43 - Mandatory HIV Testing in Texas Prisons

Rep. Yvonne Davis' bill requiring HIV tests for all Texas inmates just prior to release will be heard this morning in the House Committee on Corrections. Texas AIDS Network will testify on the bill.

It took some doing, but we finally got a chance to talk to an aide in Davis' office about the bill and share our concerns. Our understanding is that Rep. Davis will introduce a committee substitute, but the only addition is to clarify reporting requirements for test results.

The bill is deceptively simple, as we discussed earlier. It simply changes "may" to "shall" or "must," applies to both state prisons and state jails, and applies to prisoners about to be released from the institutions. The fiscal note for the bill says that it won't impact the state's budget.

On one hand, the Network would like to support the bill.

• The incidence of HIV is about 7 times higher in the Texas criminal justice system than it is in the general population. The state releases a little more than 100 HIV-positive prisoners each month, according to the Texas State Epidemiologic Profile, 2005. The actual number of HIV-positive prisoners may be higher.
• Upon release, ex-prisoners often seek to do those things that they were not allowed to do while in prison. This may include behaviors that can lead to the transmission of HIV or other infectious diseases.
• The over-representation of African Americans in the Texas prison system, coupled with their over-representation in current HIV surveillance reports, suggests that there might be some net benefit to prevention, especially for that community, if some policy like what is being proposed in HB 43 is implemented.

On the other hand, we have some concerns about the bill.

• The Network bases its advocacy on a set of policy principles that provide a framework for progressive public policy for HIV/AIDS education, prevention, and treatment. Principle 9 says:

"There are no scientifically valid grounds for the mandatory HIV testing of specific groups of persons. Public health policy regarding HIV testing should be firmly grounded in current scientific evidence regarding risk of HIV transmission and should take into account the social and economic impact of HIV testing."

• The Network would rather see the testing protocol be "routine" rather than "mandatory." This would allow a prisoner to opt out of the test if he/she really objected to being tested. Our justification for this is simply a matter of human rights, allowing the individual to make an informed decision regarding his/her own health.
• That matter of "informed decision" is also a concern. Any HIV test administered in the state of Texas is supposed to be accompanied by pre-test counseling which allows the individual to have the information needed to make a decision regarding testing. If testing becomes mandatory in Texas prisons, there appears to be no concomitant requirement that any sort of counseling or education precede the test.
• In the case of a positive test result, Texas law also requires post-test counseling regarding prevention and treatment. This law is often disregarded, so we think it would be worthwhile to reference the relevant part of the statute to make sure that this counseling occurs.
• When this counseling occurs is also important. A positive test result is not like saying, "Beef! It's what's for dinner!" This is a life-altering moment. This is news that pretty much shuts out the world and all that it might have to say while the individual processes the fact that he/she has a life-threatening disease that is more than a little socially unacceptable. (Not only are you going to die, people won't like you anymore!) HB 43 makes no provision for timing of the test--and therefore does not allow time for an individual to adjust to a positive test result or make arrangements for living with HIV after release. Just as important from the perspective of the bill as a prevention bill, there needs to be some time allowed for the individual to be able to receive and understand the prevention information that he/she now needs in order to protect future sexual partners.
• The bill makes no reference to after care. There is some indication that after care is now a concern at the Texas Department of Criminal Justice, but there is also anecdotal evidence that what is said to happen doesn't always happen. The Network would prefer an explicit reference in the bill to TDCJ's responsibility to provide referrals and assistance in making connection with local community HIV services and, when appropriate, the Texas HIV Medication Program. For community services, this might include introduction to a case manager, even if only by telephone, and setting up an appointment to begin services, preferably within 30 days of release.

We'll see how it goes.

[Edited to correct embarrassing error in the number of prisoners released each month.]

US under fire over needle exchanges for AIDS prevention

The controversy regarding the current administration's stand on needle exchange is expanding. In a letter coordinated with 300 organizations from 56 countries, Human Rights Watch laid out concerns about the US' pressure on the UN not to support needle exchange programs. While the "mainstream" view is that needle exchange is a public health solution to a public health problem, the US is taking the position that needle exchange contributes to drug use and is, therefore, part of the public health problem. The US, not surprisingly, is advocating abstinence.

The result:

"We must not deny these addicts any genuine opportunities to remain HIV negative," Antonio Maria Costa, head of the UN Office on Drugs and Crime (UNODC) told in Vienna on Monday the 48th session of the UN Commission on Narcotic Drugs (CND).


Costa said that contaminated syringes were a major source of transmission of the HIV virus and other diseases including hepatitis, especially among drug users whose capacity for rational thought was diminished.


"We reject the false dichotomy that either drug control prevails, with no consideration for HIV, or that HIV prevention prevails with no consideration for drug abuse," he added.

. . .

Costa had said in a letter sent in November to the US State Department that the controversy over US objections to needle exchanges "continue to place... (Costa's office) in a difficult position," according to a copy of the letter obtained by AFP.


Costa said the United Nations does not "endorse needle exchanges as a solution for drug abuse nor support public statements advocating such practices" and feels such "prophylactic measures to prevent the spread of HIV/AIDS should be undertaken only within the overall effort to reduce druge abuse," the letter said. (sic)

Progress on state HIV appropriations

Items from Article II that were pended from the March 3 meeting of the Senate Finance Committee were sent to a workgroup, chaired by Sen. Judith Zaffirini (D-Laredo). The workgroup reported back on March 8 with its recommendations for items to be included in the final appropriations bill. The recommendation included $15 million for HIV and did pass.

The background of passage is a bit more interesting. You can listen to the archived broadcast of the March 8 meeting by scrolling down on the linked page to March 8, Finance Committee (part II). The relevant section occurs at about 2:19:00 in the broadcast.

The committee minutes are fairly cut and dried on this portion of the meeting:

The chair recognized Senator Zaffirini to lay out the workgroup recommendations and riders for Article II.

Senator Zaffirini moved to adopt the workgroup recommendations for Article II. There was a roll call vote. The motion carried with a record vote of 11 ayes, 3 nays, and 1 absent. Senator Averitt, Senator Barrientos, and Senator Staples requested unanimous consent to be shown voting aye, and Senator West and Senator Shapleigh requested unanimous consent to be shown voting nay; without objection, it was so ordered.

When Sen. Zaffirini reported that the workgroup recommended $15 million for HIV, she was challenged by Sen. Nelson. Sen. Zaffirini then reported that the item had initially been defeated in the workgroup on a 1-3 vote. A second vote had the same results. The third vote ended in a tie (2-2). Sen. Nelson questioned why the amount was brought forth as a recommendation. Sen. Zaffirini made reference to Chairman Ogden's support, there was laughter in the chamber, and the matter was dropped. Sen. Ogden was heard to make the comment: "That's my compassionate side showing."

All of these bits and pieces make for several important points:

1. The possibility of getting an appropriation of $15 million for HIV is one step closer. The Senate Finance Committee's recommendation must be approved by the full Senate. Now would be a good time to make sure that one's own Senator will support the Finance Committee's recommendation for $15 million for HIV.
2. Senators Shapleigh and West would ordinarily have been supportive of the request for funding for HIV. Since the vote on HIV funding came in the same package as several other issues, one or more of those other issues may have determined their need to vote "no" on the entire package, including, unfortunately, HIV. Since their late vote didn't affect the outcome (and Sen. Nelson was the only "nay" during the live vote), there is every likelihood that there was some other driver for their votes. Indeed, Sen. Shapleigh spoke up in support of HIV funding during the discussion. However, it would be good to know why Senators Shapleigh and West voted "no" and to encourage them to support HIV funding in the future. This would, of course, come best from people who live in their districts and should be done with great politeness.
3. It is worth noting that this vote is perhaps the single most critical vote in the entire process that leads to a final appropriations bill. There are still several points at which funding for HIV can be defeated, but this was the point at which HIV funding had to be added to the bill. Sen. Zaffirini's strong stand in the face of opposition--and Sen. Ogden's decisive support--were clearly heroic. They deserve our thanks.

Drugs, Lies, and Needle Exchange

Kevin Drum's blog has a post about an editorial in the Washington Post (registration required)that started a lively discussion about the effectiveness of needle exchange and the degree to which the current administration in Washington adheres to the truth. The central focus of the WP editorial is an interview with an anonymous Washington official regarding needle exchange and the anonymous source's assertion that at least three scientific studies showed that needle exchange was ineffective. The WP reporter then called the researchers responsible for all of those studies and asked what their conclusions were. In all three cases, their conclusions were that needle exchange programs were indeed effective rather than ineffective, as the anonymous source had asserted.

In the past, the tactics used to oppose needle exchange programs at the federal level centered on the quality of science in the research about needle exchange. As that has improved, apparently the new tactic is just to invert the outcome of the research and to assert that it says what NEP opponents wish it would say.

The context for the WP editorial is actually international. Most of its discussion centers on the need for needle exchange programs in other countries (e.g., Russia) and pressure being applied to the United Nations to abandon those programs. However, there is also relevance for the issue here at home.

• There is a current ban on spending federal funds for needle exchange programs.
• Texas paraphernalia laws make it difficult for needle exchange programs to operate out in the open in Texas.
• Of course, no state funds are being provided to support needle exchange programs either.
• Injecting drug use is a significant driver for the HIV epidemic in Texas.

Senator Jon Lindsay has introduced SB 127, to allow for the legalization of needle exchange programs in Texas. The bill was also introduced in the last legislative session, received a favorable vote from the Senate Health and Human Services Committee, but failed to receive a second reading in the Senate (i.e., someone blocked it). Senator Lindsay's stature is such that the bill is likely to get a hearing this session and may well be voted out of committee. The problem will be to get it to the Senate floor (and then, of course, through the House).

One thing that will help, I think, is for there to be an accurate representation of the science that considers needle exchange. The possibility that the same tactics being used in Washington will be used in Austin exist. It's our job to counter that with the truth.

HIV Advocacy Day, 2005

It's in the history books now. Seventy-five advocates, 2 training sessions, 181 visits to legislative offices, 181 green folders. HIV Advocacy Day was, by all accounts, a grand success. Not the least of our success were the meeting reports that advocates completed to let us know what happened during their meetings. Good stuff in there!

Thanks to all the organizers in Houston, Dallas, San Antonio, and Fort Worth for bringing all these wonderful folks together. It was nice to see old friends and make new ones. Ham that I am, I thoroughly enjoyed providing the briefing sessions for such a receptive audience.

Now, as always, the paperwork still has to be completed. I hear that folks are getting their thank you letters written. (This is excellent!) I have already entered the registration forms into a database and the certificates are being printed out as I type this. Getting them mailed will take a bit of work (I've stuffed more than enough envelopes for one lifetime, thank you very much), but they will get to you pretty soon, I think. There are still a couple of steps to go before I actually start stuffing those dreaded envelopes. Hang in there!

HIV Infection Rate Among Blacks Doubles

Jeff Donn reports for the Associated Press on research presented in Boston at the 12th Annual Retrovirus Conference that:

The HIV infection rate has doubled among blacks in the United States over a decade while holding steady among whites — stark evidence of a widening racial gap in the epidemic, government scientists said Friday.

The study on which Donn's report is based excluded the homeless, soldiers, and prisoners, making it likely that the infection rate in the African-American community may be higher. Adding insult to injury, the study shows that as much as 44 percent of those who need to be in treatment in this country are not.

FDA Approves First Ever Treatment for Hepatitis C in Patients with HIV

A press release by Roche pharmaceutical company talks about its new FDA approval and what it means for people living with HIV and Hepatitis C:

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved the first and only hepatitis C treatment, Pegasys(R) (peginterferon alfa-2a) in combination with Copegus(R) (ribavirin, USP) for patients coinfected with HIV.

Hepatitis C and HIV are the two most prevalent blood-borne infections in the United States. It is estimated that approximately 30 percent of Americans with HIV are believed to be infected with the even more common blood-borne virus hepatitis C. Chronic hepatitis C affects approximately 2.7 million Americans and HIV, almost one million. Research has shown that hepatitis C is more resistant to treatment in people with HIV.

The approval of Pegasys combination therapy for the treatment of hepatitis C in HIV patients was based on results from the largest study of its kind conducted to date. The results showed that 40 percent of the 860 patients treated had the levels of their virus become and stay undetectable for at least 24 weeks after finishing a course of treatment.

In Texas, this sort of treatment would be available through private insurance and Medicaid (both are listed on the Medicaid formulary as preferred drugs that do not require prior authorization). The Texas HIV Medication Program does not provide treatment for co-infection with either Hepatitis C or tuberculosis.

Happy Valentine's Day

Watch this video. (Watch it all the way to the end. It can get loud, so close the door or adjust your sound.)

It's more fun if I don't give away the surprise, but this link tells you why this video seems appropriate for Valentine's Day.

Senator Lautenberg Introduces Legislation to Provide Comprehensive Sex Education in Schools

In a refreshing change, bills have been introduced in Congress to fund reality-based sexuality education in the schools. Neither text nor numbers are available on Thomas yet, but here is Sentator Lautenberg's press release on his bill.

WASHINGTON, D.C. -- At a press conference today, United States Senator Frank R.
Lautenberg and Rep. Barbara Lee announced the introduction of the "Responsible Education About Life (REAL) Act"; legislation that will bring a comprehensive
approach to teaching young people about the risks of sex, and the steps necessary to prevent unwanted pregnancies and Sexually Transmitted Diseases (STDs).

The measure will create a grant program administered by the Department of Health and Human Services (HHS) that would award $206 million per year to states for comprehensive sexuality education programs that would include medically accurate information about both abstinence and contraception. While $206 million in federal funding currently exists for "abstinence only before marriage education", there is no funding dedicated to comprehensive sex education.

"Abstinence only education only tells young people half the story, and they need the full picture," said Senator Lautenberg. "The abstinence-only programs funded by the federal government are not getting the job done."

Even the Heritage Foundation finds that "Some 75 percent of parents want teens to be taught about both abstinence and contraception." A Hickman-Brown 1999 poll reports that 93 percent of Americans support teaching comprehensive sex education in high schools.

"The REAL Act is a step in a more effective direction. It brings sex education up-to-date in a way that will reflect the serious issues and real life situations millions of children find themselves in every year," said Lautenberg.

I'm guessing that this won't pass, but it could open the dialogue, and dialogue is sorely needed. While abstinence is a good strategy for some people at certain points in their lives, unless one is making a lifelong vow of abstinence, there will come a point when some information about sex is going to be needed. That's the point at which reality-based information about contraception, disease prevention, and sexual health would come in mighty handy.

Routine HIV testing urged

Linda Johnson writes for the Associated Press that two major studies are advocating routine HIV testing. Such testing would be cost effective since the savings in detection and early intervention would outweigh the cost of testing, except for the celibate and monogamous. The VA participated in one of the studies and appears likely to go ahead with routine testing.

Testing is now routine for pregnant women in Texas. Women can opt out of the test, but the overwhelming majority consent to be tested. This has reduced the rate of perinatal transmission in Texas dramatically.

Texas budget hearings

The House Appropriations Subcommittee on Health and Human Services held its hearing on the Department of State Health Services legislative appropriations request yesterday. (The Senate Finance Committee hearing is today.) For most of the hearing, Commissioner Eduardo Sanchez held the hot seat, while he was grilled by committee members about various aspects of the budget.

The major good news related to HIV appropriations is that the 5 percent reduction originally mandated as an across-the-board cut for all state agencies has been eliminated for HIV. The Legislative Budget Board recommended restoring $4.1 million to HIV, keeping funding at 2005 levels.

However, new actuarial studies of the projected needs of the Texas HIV Medication Program show that the shortfall for FY 2006-2007 is higher than previously projected. The actual need is a little over $15 million (up from $11.7 million). Again, there is good news in that the Department of State Health Services has amended its legislative appropriations request to seek this higher amount of funding. (Historically, getting the Department to do that has been almost impossible.)

During the hearing, the subcommittee members asked several questions about HIV and STDs. All of them showed concern about the direction of the epidemic and the effectiveness of prevention.

• Rep. Isett (R-Lubbock) expressed concern about the apparent disparity between the low amount of funds being spent on abstinence education and the high amount of funds being spent on the treatment of HIV and STDs. He asked for more information about what other prevention programs were being provided. He also requested more information about funds being spent on HIV in other programs.
• Rep. Dukes (D-Austin) and others entered into a dialogue about the Texas A & M study of abstinence education in Texas.
• Rep. Luna (D-Corpus Christi), Vice-Chair of the Appropriations Committee, sat in on most of the hearing. She asked whether there was unmet need for HIV services. Are people who are not getting services from the Department going elsewhere for care, and does this involve cost-shifting to local communities?
• Rep. Davis (R-Houston), Chair of the Subcommittee, asked about the epidemiological trends for HIV and STDs and reasons for recent increases in new cases.

The Department will be providing additional information to committee members in response to their questions.

Thanks to Rep. Dukes, the hearing also included a lively discussion of Hepatitis C programming in the state. It appears that rumors that most Hep C programming would be abandoned are now not true. (We'll see.)

Texas AIDS Network testified in support of the the exceptional item request for $15 million for HIV medications, thanked the Legislative Budget Board for restoring the 5 percent reduction, and requested that Rider 29 (relating to abstinence education) not be amended.

AARP blogs Social Security

If you are trying to keep up with the debate on Social Security, AARP now has a blog which covers some of the basics and the ongoing dialogue. There is a very real concern that changes in Social Security will negatively affect support for disabled persons.

. . . via TPM.

FDA warns about home test kits

The FDA has issued the following warning:

The Food and Drug Administration (FDA) is warning consumers not to use unapproved home-use diagnostic test kits that have been marketed nationwide via the Internet by Globus Media, Montreal, Canada. In fact, no home-use test kits intended for diagnosing HIV*, syphilis and dengue fever are approved for sale in the U.S. The use of these products could result in false results (though there is no confirmed evidence of false positives) that could lead to significant adverse health consequences. The illegal kits are labeled as:

• Rapid HIV Test Kit
• Rapid Syphilis Test Kit
• One Step Cassette Style Cocaine Test
• One Step Cassette Style Marijuana (THC) Test
• One Step Cassette Style Amphetamine Test
• Rapid Dengue Fever Test
• One Step Midstream Style HCG Urine (Home) Pregnancy Test

FDA has not approved or evaluated the performance of any of Globus Media's products. As a result, consumers cannot know with any degree of certainty that test results are correct. For example, a person testing positive for HIV (human immunodeficiency virus, or the AIDS virus) using one of these tests may not be infected with HIV, or, worse, someone infected with HIV may test negative and not seek medical treatment, or spread the virus to others.

The tests were sold through websites and distributed throughout the U.S., usually by overnight delivery services. They have been made available for sale on several websites, including www.htkit.com and www.hstkits.com. The kits usually are contained in a paper envelope with instructions inside the packaging. The envelope, instructions and packaging may not accurately identify the manufacturer, packer or distributor. The name of the kit appears on the instructions. Consumers who have these products should not use them. Anyone who has used one of these test kits should be retested using valid test methods. The FDA has issued an import alert which alerts FDA field personnel to the possible importation of these devices, provides guidance as to their detention and refusal of admission into the U.S., and also advises U.S. Customs officials about these products. Other unapproved tests may also be available through the Internet. You can find a list of FDA approved / licensed tests for HIV and Hepatitis on the FDA website at http://www.fda.gov/cber/products/testkits.htm. [emphasis added]

*Please note that one licensed/approved diagnostic home collection kit for HIV, which is mailed to a laboratory for testing and confirmation, is commercially available in the United States.

Congressional Schedule

Congress' schedule for 2005 in now available.

• The HTML version lists the dates of various recesses and when Congress will reconvene.
• The PDF version is in calendar format, showing days in session in blue.

You can, for example, use these resources to plan visits to your congressional representatives' district offices.

Bush Budget May Harm PWAs

The response to the President's budget is starting to trickle in. The consensus is likely to be that this budget will cause some real problems for people living with HIV/AIDS. Not only is the proposed increase ($10 million) too small to fit the need (NASTAD recommended an increase of $197 million for AIDS drug assistance programs), cuts in other places will negate any potential benefit.

"This budget does not reflect the concern President Bush showed during his State of the Union for HIV and AIDS care and prevention," said HRC Vice President of Policy David M. Smith. "Unfortunately, the President's actions do not match his words."

. . .

In addition, the Centers for Disease Control saw a $4 million cut to its budget for HIV/AIDS prevention and surveillance. At the same time, unproven non-science-based abstinence-only programs, which do not include education about how HIV/AIDS is transmitted, received $38 million in additional funding. A recent study at Texas A&M University showed that teenagers taking abstinence-only sex education programs endorsed by the President became increasingly sexually active, which is the exact opposite effect that the program is designed to have. "Programs which focus on abstinence as the sole means of preventing HIV/AIDS put our young people at tremendous risk," said Smith. "The President has repeatedly stated his commitment to combating the spread of HIV. We have to question that commitment when his ideology consistently outweighs sound scientific facts."

. . .

Despite the President's recognition that HIV/AIDS is a growing problem in communities of color, the Minority AIDS initiative was flat-funded. Also, $14 million was cut from the Housing for Persons Living With AIDS program, which helps people living with HIV/AIDS afford housing. Having stable living conditions increases the chances of strict adherence to drug regimens, which is necessary for fighting HIV/AIDS and also prevents the development of medication-resistant strains of the virus.

President Bush's budget also includes Medicaid cuts of at least $45 billion over the next 10 years. These cuts would greatly affect a program that is responsible for providing health care to 55 percent of all adults living with AIDS and 90 percent of all children the HRC said.

The good news is that Congress still has something to say about all of this. Letting your congressional representatives know what impact this budget would have on you and your community would be a good place to start. See Texas AIDS Network's "Who Represents Me?" to find out how to contact your representatives.

The President's Budget (part 2)

Well, if I read this correctly(see page 429 [or 3 of 49 in this file]), the President is recommending only a $10 million increase for the Ryan White CARE Act with slightly more than half of that being earmarked for the AIDS drug assistance programs.

This amount will not be adequate to help Texas maintain current services for its clients in the Texas HIV Medication Program. It will effectively constitute another cut for other services provided under the CARE Act.

Ouch!

The President's Budget & HIV/AIDS

According to the federal Office of Management and Budget, President Bush has addressed HIV/AIDS thusly in his proposed budget for federal FY 2006:

Battling HIV/AIDS:
o The Budget devotes almost $18 billion for domestic AIDS prevention, treatment, and research, including almost $2.1 billion for the Ryan White CARE Act program (and its comprehensive approach to address the health needs of persons living with HIV/AIDS.)
o Under the President’s five-year, $15 billion Emergency Plan for AIDS Relief, the Administration has moved quickly and efficiently to mobilize the scientific and programmatic expertise,leadership, and resources of HHS and other Federal government agencies and their partners both here and abroad.

Without specific numbers, this sounds like so much smoke screen. The Ryan White CARE Act numbers don't sound like an increase, but, at this level of rounding, it would be hard to tell.

House Appropriations on Dual Eligibles

Clicking on the title for this post will bring up the broadcast for the House Appropriations Committee meeting held this morning. (RealAudio is required to view the broadcast.) The second item on the agenda was a presentation regarding the state's "give back" requirement under Medicare Part D. The discussion occurs about 17:55 (minutes:seconds) into the broadcast and ends at about 58:00.

Melitta Bustamante, an analyst for the Legislative Budget Board, laid out the basics on the state's role in financing prescription drug coverage for Medicaid/Medicare dual eligibles beginning January 1, 2006.

At that time, dual eligibles will no longer be able to receive medications through Medicaid. Instead, they will receive them through Medicare. The medications themselves will come from private providers (HMOs, insurance companies) that choose to participate in providing this pharmacy benefit. Persons who are dual eligible will be able to choose (in most cases) among two or more programs. A premium and co-pays will be charged. Each provider will determine its own formulary.

The state will be required to "give back" to the federal government's Medicare program 90 percent of the amount that it would otherwise have spent on providing medications for this group of people. (The estimate is that there are 316,000 dual eligibles in Texas.) The amount of the "give back" will decline over a period of years until it reaches 75 percent, so that the state will eventually "save" 25 percent of the cost of providing medications to this population.

Questions from Representatives Vilma Luna, Dawnna Dukes, and Graig Eiland zeroed in on several elements still at issue on this program. Dukes spent a fair amount of time questioning what would happen when a needed drug is not on the formulary of the provider selected by a client. She also pointed out the heavy burden of co-pays on the low income population. Representative Luna discussed the problem of clients being targeted by aggressive marketing campaigns with the result that naive clients may end up signed up for (and financially obligated to) more than one program. Representative Eiland asked some pointed numbers questions about losses to Medicaid from drug rebates (suggesting that the cost savings of Medicare Part D are less than 10 percent).

If you're at all wonky, this is a good session to listen to. I just hope that your feed is better than mine. The whole committee looked like smurfs.

Leavitt Sees $60 Billion in Medicaid Savings

(registration required to read entire article)

Ceci Connolly, writes in the Washington Post, that the new Health and Human Services Secretary Mike Leavitt

said yesterday that $60 billion can be saved over the next decade in the Medicaid health program for the poor by closing loopholes, prohibiting "accounting gimmicks" by states and eliminating wasteful spending on items such as overpriced prescription drugs.

Leavitt assured his audience that there would be no cap on mandatory benefits under Medicaid, but that left in limbo the question of what the administration might do about such optional services as prescription drugs.

Diane Rowland, executive vice president of the nonpartisan Henry J. Kaiser Family Foundation, said that because children are the largest group of mandatory beneficiaries, Leavitt's comments seemed to indicate "the potential goal here is to reduce spending on the aged and people with disabilities, who tend to be classified as optional and are the most expensive."

Unfortunately, details of that $60 billion in savings are elusive.

He promised aides would provide details on the $60 billion in savings. But a staff e-mail later said only: "The estimated savings numbers used in the speech are formal HHS estimates and can be attributed as such."

The Texas Health and Human Services Commission publishes an annual report on Medicaid in Texas, the most recent called Medicaid in Perspective 2004. In Chapter 5 (p. 16), a pie chart shows the federal budget expenditures for FY 2003. Medicaid and CHIP combined comprise 8 percent of spending. (Interestingly, interest on the national debt comes in at 7 percent, which is almost as much as Medicaid.) According to the Texas Fact Book 60.5 per cent of the federal funds that Texas received in FY 2004-2005 were for health and human services ($23,729.4 million).

Senate Health and Human Services Committee

The committee held its organizational meeting today and adopted rules. The committee's regular meeting time during the session will be Tuesday mornings at 9:00 a.m. in the Senate Chamber. The committee will meet more often if the workload necessitates it.

Governor's Budget Recommendations

The governor has made his recommendations for the appropriations for the coming biennium. While his budget document does not show allocations as specifically as the Legislative Budget Board recommendations do, the budget does show that the Governor is recommending more than $100 million less for the Department of State Health Services than the Department is requesting.

The Governor's priorities for increased funding include:

• Reform child and adultprotective services
• Create emerging technology fund
• Add offices of inspectors general
• Increase skills development fund
• Expand mentoring initiatives
• Improve student financial aid
• Etc.