Thursday, March 31, 2005

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.

Wednesday, March 30, 2005

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.

Tuesday, March 29, 2005

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.

Friday, March 25, 2005

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.

Thursday, March 24, 2005

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]

Wednesday, March 23, 2005

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.

Tuesday, March 22, 2005

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.]

Thursday, March 10, 2005

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)

Wednesday, March 09, 2005

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.

Tuesday, March 08, 2005

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.

Wednesday, March 02, 2005

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!