Dear Sir: We believe we can cure your diabetes. However, we may also have given you HIV…

A mixed-bag kind of a day for the US health care system.

US scientists have managed to rid diabetic mice of the effects of the disease using a cocktail of drugs.

The mice, who had type 1 diabetes, started producing their own insulin after taking a mixture of four drugs.

Previously the same team at Harvard University had only been able to stop the destruction of the cells which make insulin, not regenerate them.

This is good – this is flippin’ fantastic. The ability to make broken bodies regulate their own insulin? It’s an incredible discovery (and will hopefully continue to be successful through human trials).

This, however, was not-so-good:

US officials Thursday said 40,000 people may have been infected with HIV and hepatitis in a major health scare after a Las Vegas clinic was found to have re-used syringes and medicine vials.

Authorities in southern Nevada said they were notifying some 40,000 patients who received anesthesia injections at the clinic’s endoscopy center between March 2004 and January 11, 2008 about potential exposure to hepatitis and HIV.

No cases of HIV or hepatitis B infections related to the clinic’s practices have been detected yet, authorities said.

After an investigation, “the health district determined that unsafe injection practices related to the administration of anesthesia medication might have exposed patients to the blood of other patients,” it said.

“The joint investigation identified the re-use of syringes (not needles) and the use of single dose vials of anesthesia medication on multiple patients as the potential sources of contamination.”

Action has since been taken by the clinic to end such practices.

“It appears the injection practices that can lead to the transmission of hepatitis C and other bloodborne infections have been occurring at this clinic for several years,” said chief health officer Lawrence Sands.

As near as I can determine the practice hasn’t been found to be unsafe – it was always unsafe, and should not have been occurring at this or any other clinic.

The consequences certainly ought to be interesting – class-action-wise-speaking, etc.

HIV testing, opting out, public health and civil liberties

Here’s an interesting question: should pregnant US mothers have more access to civil liberties than me? My wife mentioned this story:

New Jersey will require all pregnant women to be tested for HIV unless they opt out under legislation signed into law today by Richard Codey, the Senate president serving as acting governor while Jon Corzine is on vacation.

…

Codey, who sponsored the legislation in the Senate, said it is modeled after recommendations from the Centers for Disease Control and Prevention. In a 2006 report, the CDC estimated that the rate of transmission during childbirth might be reduced to less than 2 percent from about 25 percent with a combination of universal screening, preventative drugs, Cesarean delivery and avoidance of breast feeding.

The number of children in the U.S. reported with AIDS attributed to HIV transmission during childbirth declined to 48 in 2004 from a peak of 945 in 1992, primarily because of the identification of infected pregnant women and the effectiveness of preventative drugs in reducing mother-to-child transmission, according to the CDC report.

Although she probably read it elsewhere (my wife is not a Bloomberg reader, as far as I’m aware).

My first reaction was to ponder the legislation-ness of it all – as opposed to something more English, which would be offering financial incentives to GPs/hospitals who perform X% of tests on their pregnant mothers. Trust me – it’s a sure thing. Although I haven’t (and, in all likelihood, won’t) read the legislation itself, this just seemed like non-funded command and control. The news articles I’ve seen have yet to mention how the initiative is to be funded, beyond saying things like “health care providers will …”. I’ve seen the shunting back-and-forth of bills between providers and my insurance company, from my medical tests for my spouse’s visa: nobody wants to pay for this stuff.

Which leads to the question. Pregnant mothers have the right to opt-out. This is better than opting-in, because it means more women “submit” to the test, hence more tests, more cases identified and, critically, more cases prevented. This is a public health issue, after all: HIV is a communicable disease. It’s used to keep immigrants out, and I have to get tested as a matter of course, when applying for my residency. Only I didn’t get to opt out.

Now, I’m not American: I don’t get the Bill of Rights automatically (necessarily) – that’s fine. The AIDS Healthcare Foundation (AHF), for example though, specifically identified the opt-out clause as a criticial civil liberties issue, without which they would not have supported New Jersey’s initiative. My question is, why? Given that this is a public health issue, do ‘we’ not have as much right to prevent HIV-positive children being born into the US (and, remember, this is not a Eugenic issue: if the mother is identified, she can still have a child, it’s just that we have the opportunity to prevent transmission of the disease to the newborn) as we reserve to prevent HIV-positive people immigrating into the US?

And that’s the question. I’m not suggesting that pregnant women be forced to have HIV tests; nor am I arguing that immigrants be allowed to opt-out. I’m just suggesting that a double-standard exists here, where I don’t believe it should (or, at least, stand un-addressed by the debate).

Low-Key Recall of AIDS Drug Hits World’s Poor

While I think about it, the Kaiser Foundation site is hosting webcasting of the 4th IAS Conference on HIV Pathogenesis, Treatment and Prevention. If it’s your thing. Play it in your cubicle instead of ESPN; see what happens around you..

This story, courtesy of an email from a former colleague:

ROME, July 21 — A total recall of an important AIDS drug widely used in developing countries has disrupted treatment for tens of thousands of the world’s poorest patients, with no clear word from the manufacturer on when shipments will resume.

…

The recall of the drug, Viracept, by Roche Pharmaceuticals of Switzerland, went largely unnoticed in the developed world when it was announced in early June, after the company had discovered that some batches made at its Swiss plant contained a dangerous chemical. But the recall has caused growing concern among global health officials and in AIDS programs in many poor nations. They say the company did an inadequate job of informing patients and officials about the potential risks and helping them find affordable access to newer alternative drugs.

Roche said that it had been actively working with health officials across the globe and that the risk from the affected batches was low.

The Precautionary Principle applies strangely, here. The IHT has considered it already:

Just when it looked like things were getting better for carriers of HIV in poor countries, old-fashioned negligence has thrown a monkey wrench (or spanner, if you prefer) into the works.

Perhaps erring on the side of caution, Roche recalled the drug worldwide after discovering that lots containing a cancer-causing chemical were shipped to at least 35 countries. Some countries might have received untainted lots, but their doctors have no way of knowing; even if Roche knows, it won’t say.

This is a problem because alternatives to the low-cost drug aren’t easily available. So doctors in poor countries – mostly in Latin America, Africa and Asia – may be sending back a perfectly good treatment, leaving their patients with nothing.

One side dictates the global recall; the other dictates, what? Less-than-global, I suppose. A warning, without a recall, and then some very fast and clever work on engineering some test, to detect the ‘bad’ drugs? It depends upon how ‘harm’ was defined. One gets the impression that harm to Roche was, naturally, a big consideration. Better to be criticised by these (poor) countries for treating them badly, than be known for sending out drugs that did more harm than good. I think. Honestly, would we even care? Our newspapers barely mention train wrecks that kill hundreds, and can anyone even name the places where the Asian Tsunami hit (Prof. Gunter is disqualified from answering)?

I’m being cynical, if with good cause.

Back at the New York Times:

Officials at the WHO in Geneva and the European Medicines Agency in London said Roche had not provided information they consider essential for safeguarding public health: which countries the tainted medicine was shipped to, the concentration of the contaminant and what the company will do for its patients. The European agency, which regulates drugs for the European Union, has canceled Roche’s license to market the drug.

Dr. Rago called the recall “sort of a disaster” for patients in very poor countries. He said of Roche, “They failed in communication.” Roche has denied the accusation. The company, which had revenue of $35 billion last year, said it promptly notified health providers in the affected countries to discontinue use of the drug, which is dispensed in both pill and powder form. It also said it would cover the “reasonable costs” of the recall. It did not define “reasonable co

I like the “sort of a disaster” although, to be fair, developing countries can give the rest of us lessons is disasters. Like cover-ups and crimes, it seems Roche is suffering less for the problem, or the recall, than how bloody badly it has managed the affair, and how little it is sharing with self-declared (but broadly agreed-upon) organisations of oversight. Losing the European license for their HIV/AIDS drug hardly bodes well for the company that has a license for Tamiflu, there – for those who fear avian influenza (I would remind you that God promised fire, not bird ‘flu, and that’s how we measure risks in the USA).

One benefit of a global recall is that it prevents a targeted recall being sent to hell by grey or black markets in these drugs. It is possibly better to assume all drugs are bad, than have good drugs in your country after your country’s allotment was already recalled. Again, allow for the fact that I’ve lived in only very highly-developed countries, disease free. For which I’m more and more grateful.

Seriously, though, what a mess. As the IHT’s blog asks, though, who can call Roche to account?

Wealthy Nations Should Increase Global HIV/AIDS Spending, Editorial Says

I thought I’d return to that AIDS story from India. From the Kaiser Network:

“Now that the Group of Eight industrialized nations has pledged to commit $60 billion to combat AIDS and other diseases around the world in coming years,” Congress and “other national legislatures ought to look hard for additional funds to close a looming gap between the funds committed and the needs of desperate patients,” a New York Times editorial says. Donor nations have “greatly increased their funding for AIDS programs in recent years in belated recognition that the epidemic threatens to destroy not just its victims but also the social and economic fabric of many countries in sub-Saharan Africa,” the editorial says.

Although President Bush’s recent proposal for a $30 billion, five-year extension of the President’s Emergency Plan for AIDS Relief is a positive move, the funding request “represents only a modest increase from the spending trajectory” the U.S. already was on, according to the Times. The U.S. has been “by far the largest AIDS donor in recent years, providing almost half of the funding commitments made by donor governments,” the editorial says, adding, “But when measured against the size of the national economy, the American donations rank only fifth. There is room to do more.”

The G8 pledge and Bush’s PEPFAR proposal will not be “enough to keep up with the devastating epidemics” of HIV/AIDS, tuberculosis and malaria, the editorial says, adding that tens of “billions of dollars more will be needed to provide treatment, care and preventive services for AIDS alone over the next five years.” As Congress this year “wrestles” with the fiscal year 2008 appropriations bills, it should “provide the full $1.3 billion being sought by congressional health advocates” for the U.S. contribution to the Global Fund To Fight AIDS, Tuberculosis and Malaria, the editorial says, concluding that Congress also should “set the nation – and by its example, the world – on course toward universal access to AIDS treatment by 2010” (New York Times, 6/18).

We know that AIDS funding is ever-increasing:

and putting that into some sort of context, from the same report:

The question is, is it making any difference? Talking to a friend (who reminded me that I wanted to revisit this), whose work is kind of related to this sort of thing, his perspective was that AIDS funding had gone a little IMF – in that it was used to impose “good governance” (caveat: he did say he thought this in his more paranoid moments). One can see pieces of this for themselves – the Bush administration’s horrid little gag rule a splendid case in point. Even above, the New York Times editorial tells us that Congress also should “set the nation – and by its example, the world – on course toward universal access to AIDS treatment by 2010.” What does that mean, on course toward universal access to treatment? Who defines what is ‘on’ or ‘off’ course.

The holders of the purse strings, ‘of’ course (bad pun. Sorry. I’m Australian, we can’t help ourselves).

If you go searching for longitudinal studies of HIV/AIDS, you’ll find a lot of first-world work, looking almost entirely at first-world concerns. Not so much incidence (or structure), or response to funding. We’re all more or less familiar with the pandemic,

but only in that static sense. Personally I don’t think my friend is as far off as he thinks he is: look at the response to the Indian story:

Millions of dollars have poured in from international donors, NGOs and the government for prevention and awareness programmes.

But today, this flow of funds could dry up. New estimates reveal that the number of people living with HIV could be much smaller than believed and ironically, activists fear the first casualty would be aid.

”Funding would be affected at their level. Small NGOs would be at the receiving end,” said Kaushalya, Positive Women’s Network.

That ‘small NGOs’ comment is telling. A UNAIDS’ Report on the global AIDS epidemic 2006 included the lines:

More leadership and more money are still urgently needed, and thus these two areas of focus remain essential, but now there is widespread recognition that a third focus is also vital: making the money work more effectively.

Why is this necessary? As more money has become available, more government,international, civil society and other organizations have been responding to AIDS in many of the low- and middle-income countries most heavily burdened by the epidemic. Often, there have been no mutually agreed-upon strategies or mechanisms guiding, coordinating, monitoring and evaluating their efforts. The result has been duplication, waste and serious gaps in the national AIDS response in many countries.

Often, for example, there has been insufficient surveillance to identify the people whose behaviour places them most at risk of infection and consequent failure to reach these people with prevention, treatment, care and support services.

This is the beginning of chapter 11, Getting the Best Out of National Responses. It continues into stake-holder, guiding principles, action framework speak (not my bag).

I’m not suggesting funding be cut. I do get as annoyed as any other healthy-in-a-rich-country welfarist at the popularity of one illness over another, and Bono really does send me spare. Returning to the India story Anjali Gopalan, Executive Director of the Naz Foundation, said

”I see this as a very political disease. This kind of response has not come from communities in cancer and malaria, even if studies show that numbers are lesser. Donors can’t pull back now. It’s opened a Pandora’s box because we are also looking at opportunist infections. For the first time because of HIV there are health initiatives that have gone down to the district level.”

I mean, good, but that’s a fine demonstration of the problem – funding for AIDS has increased as though it is funding for aid. Little is known about the impact of this funding, but little enough even seems to be known about the implementation of it. With the bodies involved it is not surprising: governments and the strings that they attach to their funding, the UN, WHO and down through all of the NGOs at work in various countries.

It strikes me though that, in an age when the NHS won’t consider a treatment without some idea of its cost-effectiveness, we could do with some of that waste-not-want-not attitude in our response to the AIDS/HIV pandemic. Again, thank God, I don’t have it and I don’t need access to treatment while having no running water. Which is why I’m not suggesting funding simply be cut when a country’s numbers go down – because as I said the other day, numbers are remarkable fungible, to the point of being meaningless, things. I just think we’re spending some rather inefficient dollars on the problem.