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.