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Medical Ethics and the Rights of People With HIV Under Assault

| 49 Comments
Sorry for having such a long initial blog post. Thanks to Dr. Joseph Sonnabend for his continued leadership, mentorship and friendship. I could not have written the article below without his guidance and assistance. --- Sean

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Antiretroviral Treatment as HIV Prevention?


The approach to prevention and treatment of HIV in the U.S. has undergone a radical and dangerous shift over the past few months.

The new concept, called "Test and Treat" (TNT) or "Testing with Linkage to Care" (TLC) will dramatically increase HIV testing, identify more people with HIV and "link" them to care. Those are worthy objectives.

The danger is that some policy leaders driving these ideas are more interested in "treatment as prevention", meaning getting people with HIV on antiretroviral treatment, than they are in providing the best possible healthcare for them. Because antiretroviral treatment makes one less likely to transmit HIV, they believe treating all people with HIV is a good prevention strategy.

Neither the state of the science or government guidelines support antiretroviral treatment for every person with HIV, but advocates, public health officials and pharmaceutical companies are promoting the idea.

There are also plenty of TNT/TLC proponents, aware of the ethical issues, who rightly recognize that treatment should be recommended only within government-established guidelines supported by conclusive science.

But when important public health officials announce publicly that they seek to put everyone with HIV on treatment, it is cause for concern and ethically unacceptable without informed consent.

Belmont Commission

The beloved and enormously respected former president of the National Council of Negro Women, Dorothy Height, recently a leading advocate for HIV prevention in African-American communities, died recently. She lived a remarkable life spanning nearly a century, dying at the age of 98.

In her decades of public service, one of her most important roles was as a member of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, called the Belmont Commission. Formed in the 1970s, in the aftermath of the Tuskegee Experiment scandal, it was the first public national body to shape bioethics policy in the U.S.

The beginning of the Belmont Report addresses the boundary between medical practice and medical research: "...'practice' refers to interventions that are designed solely to enhance the well-being of an individual patient or client... By contrast, the term"research" designates an activity designed to test an hypothesis... if there is any element of research in an activity, that activity should undergo review for the protection of human subjects..."

The purpose of the guidelines in the Belmont Report, it should be noted, is to avoid unethical experimentation on human subjects, like what happened at Tuskegee. This is relevant, because the discussion concerning TNT/TLC and "treatment as prevention" has often confused medical practice and medical research.

It is clear that the health of people with HIV has become, for some, secondary to HIV prevention. Those of us with HIV are now viewed by much of the public health establishment primarily as potential infectors, "viral vectors of disease".

There are few precedents, in recent history, where drugs are given to people for any reason other than for the patient's benefit.

The occasions that come to mind are when drugs are administered as part of a clinical trial--and subject to ethical review and protections by an Institutional Review Board--or when they are administered as punishment, like with sex offenders forced to undergo chemical castration.

"Treat everyone" advocates propose to, for the first time outside of a research or punitive context, give pharmaceutical treatment to people for whom it is not been demonstrated to be of benefit.

This is an important precedent with extraordinarily significant ramifications far beyond the HIV epidemic. Where are the ethicists? Are HIV positive lives of so little value that something as monumentally unjust as this can happen and not be worthy of notice?

TNT/TLC Sounds Simple

The seeming simplicity of preventing new infections through the TNT/TLC approach is appealing. But that simplicity hides deeply disturbing truths, including that many people coerced into unnecessary treatment will suffer side effects and treatment-induced diseases. Today's treatment regimens are certainly better than what was available years ago, but they remain intense chemotherapeutic regimens to which one must make a lifetime commitment.

Testing people at risk and treating those who need to be treated should be an urgent priority. Too many people with HIV--especially people of color--don't know they have HIV until they show up in an emergency room with a severely-compromised immune system.

Spending precious resources on treatment for those who do not need it, and for whom it is not indicated as appropriate by government guidelines, while there are others in desperate need who cannot get care, or are dying while on AIDS Drug Assistance Program waiting lists, is outrageous.

There is no empirical basis to support TNT/TLC as an HIV prevention strategy. It is an experiment based on a mathematical model predicated on two assumptions, both based on inconclusive evidence. The first assumption is that treatment for everyone with HIV is the best medical strategy, and the second is that suppression of the "community viral load" is an effective HIV prevention strategy.

It is as though a decision has been made to redirect the country's public health response to AIDS from proven behavioral interventions, like condoms and prevention education, to the use of anti-retroviral medications.

Public health officials' focus on treatment as prevention and the pharmaceutical industry's incentive to expand markets are now in dangerously perfect alignment.

Dr. Fauci Changes His Tune

In 2000, at the International AIDS Conference in Durban, Dr. Anthony Fauci, the director of the National Institute of Allergies and Infectious Diseases, questioned the viability of lifetime antiretroviral treatment. He said "...prolonged courses of continuous HAART are not an option for most HIV-infected individuals...With current drugs, it is almost certainly not feasible to have people on therapy for an indefinite period of time."

But now Fauci--the most powerful AIDS official in the U.S.--is pursuing TNT/TLC research and programs to put all who have HIV on lifetime antiviral therapy. NIH press releases and documents frequently refer "immediate treatment" for all who test positive, "early treatment" or "universal treatment". The NIH rarely references the possibility that some people with HIV may not need, or be helped by antiretroviral treatment, or that they could be harmed or killed by it.

Dr. Carl Diffenbach, appointed by Fauci as director of the NAID's AIDS division, posted an article in March (http://blog.aids.gov/2010/03/putting-tlc-to-the-test.html) that makes no reference to the complex ethical issues and is offensive in his patronizing attitude towards people with HIV, whom he represents solely as potential infectors:

He writes "Yet these individuals can continue to spread the virus in their communities until we entice them to step through the door, whether it's giving them a pat on the back or offering financial incentives...It seems like the hardest aspect of the experiment is getting those who test positive to report for treatment."

Press releases for an NIH-funded program underway in Washington reference a pilot program to study the "...test-and-treat concept aimed at stemming new cases of HIV infection." That is different than a program aimed at improving the health of the individual patient.

San Francisco Leads TNT/TLC/"Treatment as Prevention"

San Francisco's department of public health has pioneered the "treat everyone" approach. On April 2, the New York Times reported "In a major shift of HIV treatment policy, San Francisco public health doctors have begun to advise patients to start taking antiviral medicines as soon as they are found to be infected, rather than waiting -- sometimes years -- for signs that their immune systems have started to fail."

The SF director of public health, Dr. Mitchell Katz, told the Bay Area Reporter, "...we believe all HIV-infected persons should be treated with antiretroviral therapy unless there is a strong reason not to..." Katz is disingenuous in implying the prevention aspect of TNT is a coincidental, secondary aspect: "I do anticipate it will drive down the rates of new infections. It's a nice, secondary benefit of this new policy."

Katz's decision to use an unproven strategy risks the health of some people with HIV in his city in order to try and slow the spread of the virus. This does little to address one of the major factors for HIV transmission in his city, acute infection, when someone is especially infectious and HIV tests are least likely to be accurate.

The possibility that he truly believes treatment is appropriate for all people with HIV only supports labeling his approach "faith-based medicine".

At the same time, he has also proposed radical budget cuts for traditional behavior-based HIV prevention strategies. As goes San Francisco on HIV prevention, so may go the nation, further jeopardizing condom promotion and behavioral-based prevention strategies in favor of test and treat.

Project Inform's View

Project Inform, an important AIDS treatment advocacy group also based in San Francisco, has changed its position on when to commence treatment. In January they updated a sensible paper that said "There's no definitive answer on the best time to start. Some people choose to put off taking meds for as long as safely possible. Others decide to start earlier in the course of their disease. Both strategies have merit and both are supported by some research."

But a few days ago, they made an about face, unsupported by conclusive science, which advocates treatment for all: "Project Inform believes that the long-term damage from untreated HIV is greater than the potential damage caused by long-term use of HIV medications..."

Project Inform now suggests starting antiretroviral treatment before one's CD4 count (a marker for the strength of one's immune function) falls below 500; the U.S. government recommends treatment after one's CD4 cell count falls below 500; most other countries around the world don't recommend treatment until one's CD4 count falls below 350.

What happened between January and April that caused such a change in their position?

Pharma Funding Promotes Treatment as Prevention

This has been a boon to pharmaceutical companies looking to increase their potential markets. They have been glad to promote the "treatment as prevention" bandwagon.

Recent promotional literature for a pharma-funded continuing education "Best Practices" symposium for doctors makes it clear the purpose of the training is for HIV prevention, not the care of the individual patient: "Enhanced Test-and-Treat approach for the Prevention of HIV Transmission".

"The goal of this activity is to provide the skill set for clinicians to implement state of the art strategies and technology on universal testing followed by early universal treatment in an effort to get patients enrolled into care earlier and to maximize prevention opportunities."


The statement of purpose doesn't say anything about improving patient health outcomes, as that isn't the point. The point is to get people on antiretroviral treatment and neutralize them as potential infectors.

New York's Albert Einstein College of Medicine and the Jacobi Medical Center, who are sponsoring the event, ought to be institutionally ashamed of themselves.

The Great Unanswered Question: When To Start Treatment?

An indisputable truth nearly 30 years into the epidemic, 25 years after the first anti-HIV drug and 15 years after discovery of the combination therapy that has saved so many lives, is that we still do not know the best point in the course of the disease for one to start treatment.

The most common marker of HIV disease progression is a type of white blood cell called CD4 that combats infection. A healthy HIV negative person might have a CD4 count of 600, 800, 1000 or more. For people with HIV, the lower the CD4 count, the greater the likelihood of opportunistic infections and AIDS-defining illnesses. A CD4 count below 200 is one marker for an AIDS diagnosis, even in the absence of any opportunistic infections.

Last December, in a controversial vote, a government advisory panel issued guidelines recommending treatment for all people with HIV whose CD4 count is below 500. Previously, the recommended treatment commencement point was 350, which remains the standard in most countries around the world.

The "when to start" question has vexed the epidemic since the 1986 introduction of zidovudine (then popularly known as AZT) and which was the first antiretroviral approved for use against HIV. For some at late stages of the disease zidovudine was a miracle treatment, bringing them from the brink of death back to life. But resistance to zidovudine developed within weeks or months and severely immune-compromised patients then usually resumed a rapid decline to death.

For many with higher CD4 counts, the toxicities of zidovudine--then administered at a higher dose than today, when it is used as part of a drug combination--proved to outweigh potential benefits.

Resistance remains a problem today, which raises an important question for those who advocate putting everyone with HIV on treatment. What will they tell those who are put on treatment unnecessarily and develop resistance when they get sick? Starting treatment too early limits options that may be needed later in the course of the disease.

Some argue for "hit hard, hit early", meaning treat aggressively as soon as a person was diagnosed with HIV. There are valid arguments in favor of this approach, especially in the days and weeks immediately following infection.

Others, including some of the most well-respected researchers, scientists and clinicians, advocate caution, believing it makes more sense, in the absence of conclusive evidence in favor of early treatment, to wait until there is clinical manifestation of disease or one's CD4 count falls below a certain level.

Why Wait To Start Antiretrovial Treatment?

Antiretroviral therapy creates a reservoir of potentially dangerous toxicities that cause serious and sometimes deadly side effects, the extent and severity of which have usually not been discovered until long after they are introduced into the marketplace. While it is life-saving for those who need it, antiretroviral therapy is a lifetime commitment to serious chemotherapeutic agents and should not be undertaken lightly.

From infection to the point where one's CD4 count falls below 500, when the government advises starting antiretroviral treatment, often takes years, but it varies dramatically from one person to the next, depending on co-factors, genetics, access to care and other factors. Some people with HIV are known as "slow progressors" and a few long-term non-progressors may never need antiretroviral therapy.

The longer people with HIV take the drugs, the more we learn about toxicities and side effects. Fat redistribution causing facial and bodily disfigurement, including what is known as "protease paunch", "buffalo hump" and "chipmunk cheeks"; dramatically increased risk of heart attacks and stroke; bone demineralization causing increased fracture risk; premature aging; kidney failure; all these are risks of antiretroviral HIV treatments.

Individuals whose health status falls outside the categories recommended for treatment may choose to take antiretroviral therapy anyway, because they and their physician believe they need it, or perhaps to make themselves less infectious to partners. Those choices should be respected.

It is unethical and irresponsible to coerce or encourage people who are not recommended for treatment under the guidelines to start therapy without fully informing them of the risks.

For those of us who were very ill and credit our survival to antiretroviral treatment, there is no question the reward of treatment greatly exceeded the risk. Importantly, many of us consider our survival to be as much about having known when not to take antiretroviral treatment as it is about having access to those treatments when we chose or needed to start them.

Our experience with HIV has consistently taught us how information, even "conventional wisdoms" about HIV treatment and prevention, change frequently over time. It is vital this lesson not be forgotten, because it is no different today than it was years ago. Too many statements, including the new one from Project Inform about starting treatment, do not adequately acknowledge this reality.

Some TNT/TLC advocates suggest side effects are less of a concern today because treatments have improved and we know more about them. But one of the most important things we have learned is how HIV drug toxicities accumulate over time. Even if a drug has been in the marketplace for many years, it does not mean that all of the long-term side effects are known.

For example, two common HIV drugs that have been prescribed for nearly 20 years were recently found to produce a metabolic abnormality called hyperhomocysteinemia. This is a condition associated with vascular abnormalities, including a greatly higher risk of heart attacks.

TNT/TLC Could Jeopardize START Trial

A definitive answer to the "when to treat" question might come from the START trial, now taking place at 90 sites in 30 countries, with an ultimate enrollment of 4,500 participants. It is vital research that we have demanded for years.

But statements by policy leaders that all people with HIV "ought" to be on treatment risk suppressing enrollment in START and jeopardizing its chance for completion. The International Network of Strategic Initiatives in Global HIV Trials has circulated a sign-on letter to raise the alarm and support enrollment in START. Their letter also questions last year's decision to raise the U.S. treatment guidelines' threshold from 350 CD4 cells to 500 CD4 cells:

"When to start antiretroviral treatment is one of the most important outstanding questions for people with HIV and their clinicians...We are concerned that some may interpret the new [US] recommendations as implying that the deferral group of this trial is no longer ethical. Such an interpretation would endanger the future of the trial in the [US]."

"We ... do not believe that there is convincing evidence to conclude that deferral of initiation of ART to a CD4 count of [350 cells/mm3] causes net harm, particularly in terms of mortality, compared with starting at any higher level... The available evidence is insufficient to determine if the adherence challenges and long-term side-effects of early antiretroviral treatment are outweighed by reduced risk of illness conferred by these medicines. Only a randomized controlled trial, such as START, can determine this. (underscoring added) ...We too are concerned that the new US recommendation:

1. raises theoretical concerns about continued enrolment of patients in the US, a substantial source of patients, and
2. is based on poor evidence and therefore might not be in the best interests of patients;
3. previous recommendations to use earlier treatment failed to recognize the negative impact of resistance and side effects, and
4. A minority of individuals has normal CD4 counts between 350-500 and would therefore be using treatment prior to any significant immune damage. It is worth noting that evidence that treatment above a CD4 count of 350 is not warranted would cost the pharmaceutical industry billions of dollars."


Volunteering to be Criminalized

TNT/TLC is closely linked to a campaign over the past several years to increase the number of people who get tested for HIV. That is an admirable objective; especially if it provides access to treatment for those who need it. The CDC estimates the number of untested HIV-positive people in the U.S. at 235,000.

Physicians should raise the subject and encourage their patients to get tested; too often, patients are left undiagnosed because they did not feel they were at risk, they were not willing to admit risky behavior, or their physician never suggested getting tested.

The CDC, NIH and others support "routinizing" HIV testing by eliminating requirements for written consent and testing patients routinely at annual check-ups, emergency rooms, etc. Pharmaceutical companies fund lobbying efforts in state legislatures, as Gilead is right now in Massachusetts, to repeal this important educational and privacy safeguard.

The single biggest obstacle to getting tested is stigma. A smarter strategy to get more people tested would be to combat stigma and discrimination against people with HIV. That should start with eliminating HIV criminalization statutes that imprison people for behaviors that pose no or little risk of HIV transmission or for the failure to disclose their HIV positive status prior to intimate contact.

Codifying discrimination in the law, as has occurred with HIV, is the most extreme manifestation of stigma. These laws often result in extraordinarily harsh punishments and treat HIV differently from human papilloma and other viruses that are more casually transmitted and that can also lead to death.

They are terrible public health policy because ignorance of one's HIV status is the best legal defense. "Take the test and risk arrest" is the message many at risk, who need to get tested, will ultimately hear.

"Routinizing" HIV testing means the person getting tested will likely not understand the potential legal jeopardy or the risks they could face once their name is on a government list as a person with HIV.

Will all the new people tested through TNT/TLC be informed, in advance, that if they test positive, their name is put on a government list? Or that health departments use those lists to target individuals for "behavioral interventions" and potentially for criminal prosecution?

Leadership from federal officials, public health leaders and AIDS organizations is urgently needed to support efforts to repeal these statutes. Yet most of these leaders have remained silent or uninvolved, even as they promote policies that will greatly exacerbate the problem of HIV criminalization.

Project Inform's statement acknowledges concerns about privacy and discrimination against people with HIV, but they minimize those concerns by noting: "However, important federal and state laws prohibit both the disclosure of medical information and discrimination against people living with HIV/AIDS." They would better serve their constituents if they also pointed out that statutory protection against discrimination is no guarantee they will not be subject to it.

Informed Consent and Voluntary Treatment


Informed consent prior to voluntary commencement of antiretroviral treatment ought to happen as a matter of course. But while most TNT/TLC advocates take pains to reiterate their intent for treatment to be voluntary, there has not been adequate discussion as to how they will get informed consent from patients recommended for treatment who do not meet the established treatment guidelines.

Will persons with high CD4 counts be told it is not certain treatment will help them? Will they be told about the likelihood of suffering side effects over time? Will they be told that respected experts advocate that people with HIV wait until their CD4 cells fall below 350 before starting treatment?

Will they be told that the recommendation that they start treatment immediately is driven in part in pursuit of a societal benefit, rather than what is best for the individual patient or proven by science?

What We Need From TNT/TLC Advocates

It is tragic that public health policy, coupled with the trend towards growing criminalization of HIV, is institutionalizing the view of people with HIV as primarily a potential threat to society--the very thing AIDS activists and leaders like the late Dorothy Height fought most passionately against.

That some AIDS advocates and organizations borne of the blood, pain and struggle of the epidemic have become partners and cheerleaders for this approach is cause for disappointment, concern and, yes, anger. We need them to reconsider their approach.

To avoid having TNT/TLC turn into a shameful episode in the epidemic, it is vital that its supporters in government, academia, medicine and the AIDS community step to the forefront as leaders in at least six areas:

  • Make sure truly informed consent is a non-negotiable, integral part of any TNT/TLC program and consistent with the Belmont Report guidelines
  • Advocate for research--including full enrollment in the START trial--to definitively answer the "when to start treatment" question.
  • Speak out against criminalization and demand federal leadership on the issue.
  • Advocate that pharmaceutical companies withdraw from lobbying for the elimination of patient informed consent protections.
  • Support a renewed commitment to behavioral-based HIV prevention programs
  • Implement meaningful participation of people with HIV, including those with diverse opinions and perspectives, in the development, design and implementation of TNT/TLC programs.
Absent such a commitment, TNT/TLC risks harming some people with HIV, preventing or greatly delaying the research necessary to determine the best point to start therapy, increasing criminalization prosecutions and creating unnecessary new HIV infections by undercutting non-pharmaceutical, HIV prevention strategies that have been proven effective.

And if you've made it this far, you're my kind of reader. Further posts won't be so long, I promise. Thanks, SOS


Sean on:

49 Comments

Show Comment(s)

Comments on Sean Strub's blog entry "Medical Ethics and the Rights of People With HIV Under Assault "

Sean the issues you raise warrants a serious national discourse and a deliberae interogation of the policies we are pursuing as a nation and the impact they have both here in the US and on a global scale. Human life must be valued, sanctity of life is a principle of not just implied but practical protection enshrined in the universal declaration of human rights. When the medical profession begins to practice medicine of faith rather than science and best practice to ensure attainment of best attainable service then its no longer medicine but something heneious and in this case quite flagitious.I think its high time the world community takes our government to task and hold them to account for their policies, actions and inactions. Good job Sean, regards. Frenk Guni. GNP+/NA Co- Chair.

Sweet- one of my favorite positoids of all-time has joined the ranks of "bloggers". A much-needed, much-welcomed addition.

Thanks for the post, love the line about survival for some of us being the fact that we knew when NOT to take medications. If I'd been hopped up on AZT in 1989 I wouldn't be here to enjoy the debut blog entry of Sean Strub.

The health of a patient IS the priority- regardless of HIV status. Thanks for fighting for us, Sean.

Thanks Sean,
Once again you have the ability to get to the point and bring to light something that is very distrubing. The organizations you cited as also promoting this idea, really need to re-examine their purpose and think about what they are promoting.
I keep thinking about what is happening in Arizona right now with the potential profiling of illegal immigrants, are HIV+ individuals next? I know it is a little off topic, but it could dove tail right into the same type of senario and be the next step after one is diagnosed.
Thanks again for this enlightment.

I think Gary is correct to link these issues to potential criminalization/profiling. And regardless of sero-status, everyone should listen up, because this issue speaks to the general philosophies and policies of U.S. healthcare institutions/companies when it comes to patients. Unfortunately, the health of a patient is rarely the overriding priority; control -- whether viral or financial -- often is. I'd be interested to hear people's personal experiences of this sort of protocol -- anyone care to share in the comments?

Sean, I totally agree with your position. I've been positive for 19 years. Was on meds for 4 of those (2000-2004) when my T-cell count dropped slightly. No way in hell I'd go back on the meds unless my count dropped dramatically. The chance of damage from the side effects is too high. This just sounds like Big Pharma trying to sell more drugs to more people.

Interesting points. Some responses:

In San Francisco, the elimination of the requirement for written consent in May 2006 was associated with a significant and sustained increase in HIV testing rates and HIV case detection in the SFDPH medical center. Populations facing the higher barriers to HIV testing had the highest increases in HIV testing rates and case detection in response to the policy change. (Simplifying consent for HIV testing is associated with an increase in HIV testing and case detection in highest risk groups, San Francisco January 2003-June 2007.

Zetola NM, Grijalva CG, Gertler S, Hare CB, Kaplan B, Dowling T, Colfax G, Katz MH, Klausner JD.) PLoS One. 2008 Jul 2;3(7):e2591.

Are there any documented negative social impacts from this policy?

Much of test and treat is also based on the concern of what untreated HIV can do in the body, not just to viral load. See: http://ebar.com/news/article.php?sec=news&article=4709

I've not seen anything which says that people will be mandated to be on treatment.

There are two arguments you make which seem to me to be double standards.

You seem to both promote the notion that things change, including conventional wisdom; and that when organizations change, they're suspect, or somehow being bought off. (And no, I don't work for Project Inform.)

The second double standard is that since the data on test and treat in lowering incidence aren't there, you and others say we shouldn't do it; and yet we've never demanded data that says that behavioral interventions lower incidence while we continue to do them and you advocate for them in this blog.

Finally, the data pointing to the reduced incidence in Vancouver and San Francisco, while inconclusive, are intriguing.


Signed -
Glass half full.


Hey, thanks everyone for your comments. Just a few responses specific to questions/points raised by Glass Half Full:

1) I don't disagree that eliminating written consent will increase testing rates. I'm in favor of people knowing their HIV status; I just think there are better ways to do it then by eliminating written informed consent.

2) I haven't heard anyone suggest treatment would be mandatory, as in forcing or requiring anyone to take it. And I can think of plenty of circumstances where treatment above 500 CD4 cells could make sense. But for public health officials to recommend treatment above 500 CD4 to everyone who is positive is misleading, as it implies there is a scientific consensus that does not exist. And to do that for prevention purposes is reprehensible; a patient must be able to trust that his or her doctor's concern is solely for them.

3) I'm curious as to what changed at Project Inform between January and April. If anything, the ACCORD data upon which the December 1 treatment guidelines revision was based came under question and further scrutiny during that period.

4) I'm not against testing a test and treat program that recommends treatment for everyone, but that is an experiment and should be done in the context of medical research, with appropriate patient protections, informed consent, etc. To impose it without such protections is unethical.

Again, thanks for everyone's comments. I'll look forward to more tomorrow.

Sean

You say that Project Inform changed its tune, but why?

What's their reason?

CD4 is just one highly specialized cell, of many highly specialized cells, in one system of many systems in the human body, all of which contribute to the overall health of a given human individual.

It's simplistic to think that HIV is SOLELY damaging CD4 and nothing else.

NOTE: I'm not choosing sides, except to side with the idea that any decision making should be based on research and not politics or lobbying or anything else other than what's good for the patients who are being treated with the drugs.

But on the other hand, knee-jerking that because it would involve dispensing more meds and so it's better for big pharma and so it must be big pharma's doing and so it must be evil and anti-HIV+-persons is as bad or worse than big pharma actually inserting itself because you people should know better. You're supposed to be *fighting* ignorance, not employing it.

IN FACT:

While reducing transmission may be one rationale, it's mainly motivated by a slew of new research showing HIV does damage in the body related to inflammation (& possibly other unknown mechanisms) long before the CD4 count indicates serious immune damage.

So starting the meds early should help people live longer.

PLUS..What's so bad about caring about reducing the spread. We are our brothers keepers, and should be thrilled to reduce the infection rate (as many of us can't seem to remember to use a condom).

I remember a time before HIV, and I'd like to live to see it again.

Anything that reduces infection rates as substantially as research suggests this would...should be welcomed with a Brass Band.

If we can't get a vaccine, then this idea is a good fill in.

Go into any sex club and you see it full of obviously pos guys, having bare back sex. At least under this scenario it might be just cum spraying around, rather than death sentences.


Great column, Welcome! The last few comments--especially that from Glass Half Full, amount to saying that the ends justify the means. They don't.

I appreciate the comments. Just a couple of notes to points raised by posters.

God of Biscuits, I didn't mean for this to be knee-jerk reaction to big pharma. Big pharma saved my life, as I wouldn't be here without them. But big pharma also has such vast resources that it is important to understand how they are deployed politically, scientifically and in the media and community profoundly influences our discourse on AIDS at a political, societal, community and even individual level. There's a lot more money that gets spent identifying new markets--proving a therapy's efficacy for this or that population--than there is being spent to try and demonstrate why a given cohort would not want to take the drugs.

Pleasure Activist, treatment may remove some of the long-term inflammation/immune activation, but it is also clear it can persist even with treatment. It is an important issue, and important research, but even as long-term issues with HIV infection are identified they must balanced against long-term issues with antiretroviral treatment and, just like the virus, the longer term one considers, the more issues that are discovered.

You say "starting the meds should help people live longer"; I say, let's finish the START trial and see if "should" turns into "definitively". We need the research, not act on the beliefs of a few in the absence of the science.

And caring about reducing the spread of HIV is important; nothing in my piece diminished that priority, other than the importance of protecting medical ethics and the rights of individual patients in the process.

Finally, to Editor911, please reconsider your comment that "anything that reduces infection rates as substantially as research suggests this would... should be welcomed by a Brass Band". Anything is a big word. Quarantining everyone with HIV would reduce infection rates quite a bit, but I assume this isn't something you would support. "Anything" must be subject to the ethical standards used for bio-medical research, which is what I ask of any "test and treat" program that intends to recommend treatment to every single person with HIV.

Again, thanks. This novice blogger appreciates the interest and comments.

Sean

There are any number of studies indicating that off-and-on HIV treatment is worse than NO treatment because it leads to the development of drug-resistant strains of the virus, something that should give the "protect the public" crowd nightmares worse than untreated HIV positive folks. Poz patients like Sean Straub are the ones we'd LIKE to care for: homeless people, injectable drug users and other substance abusers (that includes alcoholics) and ordinary people who lose their insurance via job loss or family problems are going to make continuous longterm HIV treatment just plain impossible. Let's try to convince those proposing this that they are not being un-PC or unethical but just plain unrealistic.

I agree with blogger:
let's finish the START trial and see if "should" turns into "definitively". We need the research, not act on the beliefs of a few in the absence of the science.

I think there are some cross-purposes at work here and I'm always suspicious when big pharma gets involved. That being said, I've been on HAART since 1996 and was first tested positive in late 1993 (probably seroconverted in March 1993). The first of the HAART drugs were pretty onerous especially at the dosage levels recommended back then. Still and all, I did well on them and suffered relatively few side effects. My viral load has been undetectable since 1996, my t-cell counts have been stable since then and I've never suffered an OI. All of our individual experiences are anecdotal; my experience just happens to have been highly positive. I suspect that HIV causes chronic inflammation which causes steady overall health decline. This issue needs to be studied thoroughly and carefully--and without the influence of pharma. What we don't need is another conspiracy theory.

Interesting post, Sean.

Although I would normally support any treatment regimen (within the scope of normal biomedical ethics, of course) that would reduce the transmission of HIV, the evidence that TNT does this is simply not there. Most supporters of TNT, including Anthony Fauci, point to the Granich et al. model in The Lancet (2009) to argue that TNT would be useful to slow down (or even eliminate) the HIV epidemic. The Granich et al. model, although interesting, is overly simplistic and it's applicability to the real world is questionable at best. In particular, the model:

*Assumes that all HIV transmission is 100% heterosexual

*Does not take into account drug resistance

*Is based on the South African epidemic only

*Assumes 100% of the community would be tested for HIV

*Ignores discrepancies between plasma viral load and semen viral carriage

While these assumptions are understandable within the context which they were made (i.e. a theoretical, research model), the results of this model should not be used to guide public policy, especially in communities where the epidemiology of the epidemic varies significantly from the model's assumptions (e.g. the US).

In addition, if one examines some empirical data, the efficacy of antiretroviral therapy as a method of HIV prevention becomes questionable. The HIV transmission rate in the US has been generally stable since about 1995. The HIV transmission rate in 1984 was 44.4, 11.7 in 1990, 6.6 in 1991, and about 5.0 in 2006. Critically, there was *not* a significant decline in the HIV transmission rate after the advent of HAART in 1996. In fact, the HIV transmission rate increased after the start of HAART in 1997, the only year that it increased since 1991.

Clearly, the debate over the efficacy of TNT is far from over. Both sides have compelling arguments supporting their case. However, controlled data from a IRB approved study is what is really necessary to determine whether TNT is effective as a public health policy and beneficial to the individual patient, as well as a society as a whole. If recent events have taught us anything, it is that one should not be overly dependent on models of processes that are inherently stochastic, without empirical validation.

Greetings

Sean thank you for addressing this incredibly important issue.

My concern arises out of the studies on which the 350 CD4 count basis for ART start was based. This was a cohort study featuring a large percentage of substance abusers. And the determination of 350 as a start point was based on the fact that those folks were more likely to start taking and adhering to ART at that point because they did not feel healthy.

I have made it clear that I will make the decision about when I start medication to my doctor. That decision will be based on the best available studies and science, not on arbitrary recommendations by the government.

HIV is not, and has never been, a one size fits all disease. It impacts each of us differently. The medications are the same way. As such it is incredibly important for us to be engaged in our care, which means knowing the studies, and the impacts-- being fully informed and engaged consumers of health care.

Kudos Sean! Thanks so much for this well thought out and thought provoking blog. I agree with everything you have written. I am not for treating everyone with HIV once diagnosed. There are many people who simply are not ready to begin treatment and their numbers may be high enough to sustain their life for many years to come. Simply putting people on treatment at the onset of HIV diagnosis when they are not ready will only lead to them skipping doses, not taking the meds, and thereby leading to resistance, and then they will die. For those who test poz and have very low counts, it would be best to treat them right away for their own well being, obviously. What concerns me most though, is if the LTNP's and elite controllers (who are presently in research studies in search of a therapeutic/preventative vaccine, or maybe even a cure) are made to take HAART, we may never be able to find an answer to ending this pandemic. That would be a disservice to all human beings. And putting everyone on treatment right away will skew any data related to these studies.

Had I gone on therapy back in 1989, I'm certain I would not be here today. AZT was quite toxic back then, and I watched my husband suffer on it & eventually die within 2 years of taking AZT. It was my decision, and my right as a human being, to wait to go on treatment until I needed it (10 years ago). I'm thankful for the treatment, but I don't think putting everyone on therapy immediately after diagnosis is a fruitful thing to do. However, if someone wants that treatment right away, then they should have that option.

I believe more education & awareness campaigns are very much needed in the general public. Taking steps in dispelling stigma and decriminalizing HIV transmission should also be implemented so people do not fear HIV testing. Focusing on behavior changes as well will do more to prevent infections than simply shoving toxic meds down a person's throat.

I also believe Big Pharma has it's hands in this TNT push... why wouldn't they? They have everything to gain in terms of billions & billions of dollars. They are not concerned about the health of people, really they aren't... it's all about money for them, not from a pharmacist's standpoint, but the big wigs who run these companies. The CEO's of big pharma do not care about the long term effects of putting someone on HAART when their CD4's are well above 500 & they certainly don't care if people are not ready to take these meds & lead to resistance issues. Because if that happens, another medication will be tried & more money will go into their pockets. I don't like this one bit.

Excellent post, Sean. As for the length, quick and sensational is a dime-a-dozen in this medium. I'll take thorough and fair over it every time.

These comments afterward summed it up well, though:

#Sean Strub
"big pharma also has such vast resources that it is important to understand how they are deployed politically, scientifically and in the media and community profoundly influences our discourse on AIDS at a political, societal, community and even individual level."

Agreed. This isn't about demonizing Pharma, this is a call for educated awareness on the part of the public and on the part of those writing policy and legislation regarding a group of people who are being defined solely on a disease they share.

When policy is blanketed over a group of individuals with a wide variety of medical, financial and cultural circumstances, the repercussions for the individuals affected by that policy can be devastating--no matter how benevolent the aim.

#Sean Decker
"The health of a patient IS the priority- regardless of HIV status."

Amen, amen, amen. This is the crux.

One of the issues I have with the concept of beginning HAART based on lab numbers is that I suspect not everyone starts out with the same CD4 counts. Within six months of seroconversion, my CD4 count was 430. The assumption by my (admittedly inexperienced) physician at the time was that I must have been HIV+ for quite some time. He felt this despite my consistent annual negative test results up to a year before my positive one. My HIV physician, not infected with HIV tells me his CD4 counts don't test as significantly higher than mine are now (in the 550-650 range). My panic at my low CD4 count in 1993 when I went on AZT and 3TC was probably unfounded. Not everyone is walking around with a 1200 CD4 count.

I won't wade into the details or even the right and wrong, but is this new TNT/TLC push linked to concern that traditional prevention methods (i.e., promotion of condom use) are losing efficacy? That seems consistent with anecdotal evidence, but has there been any study on that, or on what other prevention methods might work better?

On a nother note, the scenario Stella Fitzgibbons warns about above, in which everyone is pushed into treatment without adequate attention paid to ensuring continuity of access to drugs and compliance with treatment regimens, really should give people nightmares. A "prevention" method like that, which could lead to the spread of drug-resistant HIV, would only make matters worse.

Thanks for posting this, Sean! TNT policy will disproportionally affect Latinos. I think this policy will drive further underground Latinos by fear of testing positive. Our rights seem under attack from all fronts these days. Where are the voices of Latino health serviceI also find it unconscionable Project Inform's hypocrisy.

I found out I was positive in 1985 and I've never taken any of the AIDS drugs which I guess makes my experience a little different from most who might address this issue. The doctor who told me I'd be dead in 6 months to 2 years has been dead over a decade. But I'm not here to denounce drugs which I know have helped so many live longer lives. I imagine my long-term survival has more to do with my genes and has little to do with not taking the drugs. Having said that, I do think a healthy person taking toxic chemicals is not the best advice, maybe ever.

There was a similar push to get the HIV positive person to take the 'cocktail' years ago and a dear friend who is well accomplished in this field urged me to take the medical advice and pop the pills. I declined for one reason only: I felt great and could not see the logic of introducing chemicals into my body unless it became essential to do so. I continue to believe that is the logical position for most of us.

There is much in dispute over AIDS, but one thing never disputed: the drugs you take to survive are nothing short of toxic chemical compounds a normal person would never be asked to take. I remain convinced you should not take ANY toxic treatment until either your body tells you otherwise or blood work indicates it is a good choice.

Great article, Sean...I'd had some serious problems with the Test-and-Treat idea. Here they are.

The recent buzz about the “Test and Treat” program in San Francisco leaves us somewhat perplexed and deeply concerned. While the notion of testing everybody, with informed consent and vigorous counseling and guidance, is a tried-and-true notion, the idea of treating people with HIV with antiretroviral therapy (ARV) who have a CD4 count over 500 is unsupported in the literature, despite the flurry of media buzz that falsely suggests otherwise.

The evidence for this approach appears to rely almost exclusively on a study by Kitahata et al. While the findings of a 90% reduction in mortality are impressive sounding, closer scrutiny yields serious questions about the interpretation of the results.

First, the 90% reduction is a relative risk between two unmatched groups. While this may sound impressive, the reality is that, in the 350-500 range, 137 people died in the early therapy group while 238 died in the deferred therapy group. Among those with over 500 CD4 cells, 113 people died in the early therapy group while 198 died in the deferred therapy group. These are among groups of, respectively, 8,362 and 9,155 individuals. Data were censored among those who drifted into the next lower range and were subsequently treated. These are fairly small absolute numbers upon which to base public policy and clinical care decisions.

Further, the people who died did NOT die of AIDS-related conditions (tho they only amazingly had data on cause of death for 16% of the cohort). The causes of death included hepatic, renal and cardiovascular complications—the very types of issues that increase mortality among those on long-term ARV therapy.

This was NOT a randomized trial. So what you see was a lot more hep C and non-white in the deferred treatment arm...consistent with the racist nature of health care access in this country. Specifically, 44% of the deferred-therapy group were “Black” vs. 36% in the immediate therapy arm. In addition, 21% vs. 14%, respectively, had a history of injection drug use. These differences may appear rather small but no risk calculation was made (table 3) for these variables. We do know that older age and female gender placed people at risk of death.

Getting people into care regardless of race IS a good idea. Indeed, there ARE many things that can help slow progression and preserve the use of ARV. These include, but are not limited to, nutrition and some botanicals that can help slow progression and reduce inflammation. Data support this.

ARV DOES work--very well. But it is a tool that should not be wasted. While the (untested) notion that it may have some impact on an epidemiological level is attractive, it is probably irrelevant among those engaging in anal sex. Further, it is EXTREMELY dangerous to think one can rely on ARV; if people think it's OK to bareback now because they're on ARV, this increases the risk of not only STIs, but spikes in HIV load related to certain sexually-transmitted infections such as syphilis. Prevention programs, counseling, outreach, condom and needle access programs MUST be a continuing and vigorous part of prevention programs and should not be defunded to provide pharma another boondoggle.

The potential impact on the mix of prevention and treatment resources is dangerous. Clearly, in many communities, the prevention messages have been stymied, lost or inadequately presented: infection rates are not declining. To funnel huge resources into programs such as the one in San Francisco to treat people with ARV for whom there is no clinical rationale while diverting prevention funds into the coffers of bloated pharma is penny AND pound foolish. What is needed is better care for all people living with HIV.


Keith and Gregory, what fantastic comments! It really makes me feel better to see common sense being expressed; for a while all I heard online was a monotonous chorus chanting "Start treatment immediately! The evidence is mounting!" What really made me suspicious was that it was almost impossible to find the actual raw numbers behind the studies. As Gregory Carter analyzes them, they are unimpressive; it makes my blood boil that some people would push me into unnecessary chemotherapy (that is what it is) based on numbers like that.

this exceedingly thought-provoking article should make us all realize how important it is for all of us to remain alert, on our toes, on the lookout for anything good and everything suspect that "they" are trying to put over on us, should that be the case. sean's article also makes me realize yet again how lacking we are the forceful community based activism that existed with ACT UP, which was there to attend to the very matters he raises, and on the highest level, where, because of our current passivity and a president who does not like gay people, we have little contact, power, influence, where we once upon a time did. i repeat, Obama does not like gay people. Period. this includes hiv/aids. Period. we are being blindsided right and left and our useless "leaders" in washington continue to sell us down the river. the crumbs obama is throwing us are completely lacking in nourishment. why don't we all see this. you think anyone in obama's white house is going to read this article by sean strub? get real. larry

I had a conversation with a member of the Treatment Guidelines Panel today and the immediate response to my raising some of the questions posed by Sean was about the importance of lowering the "community viral load". We're now being looked at as a collective viral load needing to be lowered as the preeminent tactic for HIV prevention.

Sean, your inaugural post is compelling. Your statement that "A smarter strategy to get more people tested would be to combat stigma and discrimination" is a sad testament to the current state of HIV/AIDS. Although, it's obviously in the best interest of AIDS, Inc., and public policy leaders to keep us stigmatized and in the HIV closet.

Hey Sean, so glad of reading you here in poz blogs, just wanted to say hi and give you a warm welcome :)) nice article, thank you!!

I don't think anyone is saying "Big pharma is evil." We rely on big pharma to keep us alive. But it is also a fact that big pharma is a for-profit industry where profits, I think, outweigh patients' health. That must be considered.

And why does your phrasing of "you people" rub me the wrong way...?


"Death sentences"? You need to get some up-to-date information. Your science is flawed. HIV is not at all a guaranteed "death sentence" and when comments like yours are spread around, the stigma will only perpetuate -- and we have even more to combat.

Fantastic article, Sean! Your acute awareness, independent thinking, articulation and strength to stand up and take a stand are so appreciated by those of us who just don't have those inherent traits. Thank you! We need to clone you.

Previously, TNT sounded appealing to me on the surface. But the picture is much larger than what I had previously seen. Thank you for such a comprehensive article.

Two things keep rattling around in my head: (1) "...I will prescribe regimens for the good of my patients according to my ability and my judgment and NEVER DO HARM TO ANYONE." Sound familiar? And (2) "The ends do not justify the means." Period. Especially when those ends cannot be scientifically proven.

And I agree with a comment above that getting everyone who tests positive on antiretroviral therapy is unrealistic. Even those who feel ILL have a difficult time with adherence. How do we propose to entice those feeling WELL to make the major life changes that are necessary to accommodate proper health care maintenance once one is on meds? Where will this money come from?? This money should go to research.

And speaking of $$, I have been sitting here on the Iowa ADAP wait-list for months now (me and well over fifty others). There is no definite light at the end of the tunnel yet. So how are we proposing all of this med distribution and physician oversight when I can't even get the meds I NEED now?

[deep breath]

I have lived with HIV for 20 years. I have found this article most interesting. The resounding word I hear is expense.. This disease is expensive. Our country quickly sends medication to other countries and I know this is a needed source for third world nations, but there are people here can't begin to afford the therapy cost. When to and not to start therapy..... Well, been on and off and on and I have really just used to therapy methods. I have many more to choose from if one stops it's positive affect on stopping the virus. I stay connected to my doctor with 3 month panel reviews of current blood counts. I, myself have had to make the decision whether to be on a therapy or not. I have given my body, breaks when cd4 is high, but eventually I have to start another theapy. I know this process is just for me. I hope that anyone who thinks they are positive does take a test. It is for you and others. Getting an edge on this needless plague is the best defense. It is first for yourself. Be selfish..

Dear Sean,

I agree with everything you are saying and am personally disgusted by the idea that perfectly healthy people are manipulated into a toxic treatment and expected to bear the full responsibility for preventing HIV rather than sharing it with his/her partner. However, I think the whole debate is stuck in an outdated paradigm that we need to change.

There is no doubt today that treatment has a massive preventive effect. I think this requires that we entirely rethink these two ways we look at treatment and segregate them entirely.

1) use of HAART to treat illness
2) use of HAART to prevent HIV transmission

Option number one is a choice every person living with HIV should have at any time from primary infection to falling ill but PLWHA must never be coerced onto it. Receiving or refusing medical treatment for any life threatening diseases is an individual choice and should always be so.

Option number two should be the choice of every person concerned with HIV transmission and should not be regarded any different from condoms. A person living with HIV might prefer this prevention option instead of condoms (of course provided that all the criminalization legislation is scrapped, as it should be). A person not infected with HIV should have the same options of taking HAART prophylaxis before potential exposure. As an HIV negative person, I might want to use HAART just as women use birth control pills because I want to fuck without condoms.

Of course lots of research still needs to be done but I believe issues of resistance, prices of drugs and the preventive effect of HAART on HIV transmission not only in HIV positive but also HIV negative people (post exposure profilaxis) have already been proven. We need to jump forward, not getting stuck in the good old tradition of blaming and putting the sole HIV prevention responsibility on PLWHA alone.

To use a public health argument for imposing treatment on HIV positive people is absurd. We have already ripened the fruit of HAART. I was in Berlin this past world AIDS day, the capital of unsafe sex in Europe. It is a city with 3.4 million people and only about 200 new cases of HIV in 2008. There is no emergency anymore justifying draconian punitive initiatives against PLWHA or manipulating them to take treatment to strengthen prevension efforts in the western world (if there ever was such justification).

Just my two pieces of thought.

Big hugs,

Uffe

Again it would be great if PEP treat fast was the policy coming forth, however again the non-HIV policy makers are looking through rose color glasses, who are the players behind this new scheme. I waited 10 years to take meds and still healthily and no wasting. Again new policy for the sales of more drugs for it sounds like the friends at Pharma are in part behind this policy in money and action and have took the AIDS Politian named Toni Faccui as a special donor from Big Pharma . I do not want to demonized Pharma in this point, however if it smells like a pig, sounds like a pig and looks like a pig, then it is a pig. Yes, I believe Toni Faccui should retire from his post or be relieved for he is to vested in the Money Machine called PHARMA and has made friends with too many of them, for in China if a Government official was so vested in a industry it would be more than just retirement, one can only look at his appointment book and see who he meets with the most, for surly it is not the common HIV person and to look at his financial to see how many stock options he owns related to PHARMA. The sad part about these new proposed policies is that not one agency has any idea on the total number of HIV cases now or in the future in the USA. Dr. Farlin stated we have only a snap shot of HIV cases in the USA, and the CDC estimate of 235,000 people that don’t know their status is complete bullshit. Before a policy with little facts becomes the same as old policy like the prescribed 20 pills of AZT a day in the 80's that kill so many in an attempt to treat fast without incite, then more truths must come to light. I personal have self titrated my drugs for years and years after seeing many of my friends say, "I do not know what is happening for I am adherent to all my doctor has suggested, Yes wasting, kidney failure, diabetes and heart attacks from over dosing a person with experimental AIDS Drugs. I personally have been investigated by State ADAP and pressured by strong arm tactic like, if I don't take my pills then they will be cut me off from ADAP and each year they attempt another angle to pressure me to be adherent to their theory of treatment. The ADAP folks, State Pharmacy and State Doctors count my pills each month waiting to jump on me for not being adherent to their treatment option. Self titration has work for me in the limited amount of drugs I allow to go through my system for ever one is different. I lie to my Doctor and ADAP people at this time and make sure I pick up my pills monthly on time for I thought I was being kind by saving resources and being upfront at first, however again no one is interested in the truth , but the good news is I have a stock pile of drugs for the time if needed to tell the ADAP policy drones here in Florida to f... off. On the other hand it is sad that the educated and thinker can discern these schemes and the uneducated will follow ever word a Doctor tells them and that is the danger. A cry for HIV people to think and take control of their treatment option should be the new policy,for all of us HIV folks to tell our Doctors to prove their theories or let us know it is just an opinion, and not a fact. HIV people must understand if it is coming from American Academy of Medicine, CDC or NIH ,then it is most likely political bullshit or a collective of combined pig shit and smells stinky.


I can't get ADAP drugs and you're sitting on a stockpile. Big problems with the system (not a personal attack).

Thank you Dr. Fitzgibbons for your brief and insightful comment. It's also the case that they're being unrealistic as to how they're going to be paying for implementation (and I hesistate to say) of the recommendation, as it's been called. The guidelines state that there is no consensus on the issue of whether to treat for patients whose CD4 >500. I don't really see where this can be truly called a 'recommendation' (even if the Panel calls it this) and I don't interpret it as such.
I agree with Sean that informed consent should be overarching in all of these decisions of when the HIV-patient should start treatment, but I also feel that 1) doctors are not always trying to railroad you, 2) I have a responsibility to make myself an informed patient and convey the best that I can that I am an informed patient, 3) if my doctor and I disagree, I have the right to a second opinion. It's my body.
I'm not offended that after nearly four years that my current physician offers me treatment (I went on holiday in December 2006). Every time she asks if I would like to re-start, and every time, reviewing my stable labs, I say no. (I never responded to treatment with the boon of Tcell production others had, and my body controls the virus without meds) It's a little dance every time (we laugh because she knows how I'll answer), but I never feel pressured, and if I did, she wouldn't be my doctor anymore.
-Nina Martinez (public health student, 27)
Guidelines: http://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf (page 29)
Informed consent: http://ohsr.od.nih.gov/guidelines/belmont.html


Sean, as a physician privileged to take care of HIV positive patients for over twenty-five years I greatly appreciated your nuanced, non
reductionist, and appropriately concerned exposition about "test and treat" as an emerging public health policy.

I hope your essay receives a wide readership
and finds its way to my colleagues in the medical and health professions. It is worthy of a non polemic discussion and debate to help clarify
moving forward with better prevention and treatment strategies.

I think you are right to state, even if controversially and uncomfortably for some of us, that "Public health officials' focus on treatment as prevention and the pharmaceutical industry's incentive to expand markets are now in dangerously perfect alignment."

Some might argue that alignment is a good thing because drug company money and marketing power will get behind test and treat and increase its effectiveness. Perhaps if Pharma's money is used in an unrestricted way to support public health interests it would do some good but I am skeptical about that happening.

In my opinion pharma's alignment with public health is worrisome based on pharma's long history of misshaping clinical research, clinical practice and medical education. I might add the concern is not diminished because specific drug companies to their great credit have developed life saving HIV medications. Nor is the concern such companies have been richly rewarded for doing so. The concern is that drug companies in the midst of developing lifesaving drugs for HIV have over zealously marketed drugs that if worthy should sell themselves. Another concern is that too often drug companies having prioritized marketing and moneymaking over innovation and research to meet current clinical needs.

For example, drug companies are now investing heavily in HIV in formulating 2 and 1 drugs to prevent losing money when HIV medicines go generic. Another tactic is to develop "me too" drugs that add little to needed treatment options. These 2 in 1 drugs and me too drugs consume valuable resources including clinical trial resources that are supplied in part by government.

For these strategies to be maximally effective drug companies must partner with academic medicine and public health policy makers to keep these drugs as first line and on the formularies of payers.

HIV patients today need more research to support new approaches to preventing, minimizing and treating drug toxicity as well as research to better restore compromised immune systems that don't come back adequately with effective HAART. I don't believe these area are currently receiving appropriate industry support and perhaps in part as a consequence inadequate academic and public health focus. In addition, as you emphasize ongoing research such as the "START" trial is needed to define when to best start HIV treatment and with what medications in the evolving treatment landscape.

There has been much written by thoughtful people about drug companies, whether intentionally or not sometimes putting profits over patients and using undue influence to shape government and academic medicine's policies and agendas.

The interested reader might want to look at Merrill Goozner's book the "800 Million Dollar Pill" for many examples of how this works and the damage it does to patients ongoing needs for innovative research and better therapies. Another excellent source is the website Gooznews.com which reports on a these kind of stories on a regular basis.
Yet, another source is Dr. Marcia Angell's book "The Truth About Drug Companies", or in the field of HIV Business Week Editor Bruce Nussbaum's book "Good Intentions". In the past activist organizations such as Project Inform and Treatment Action Group have provided important reporting on these kind of issues as well as advocating for patient interests.

After reviewing these and other source materials I think most readers would conclude it is legitimate to question the implications of a a close alignment with industry and public health policy and want as much transparency and accountability as possible.

Sean I agree entirely with what I regard as your constructive suggestions at the conclusion:

"it is vital that its supporters in government, academia, medicine and the AIDS community step to the forefront as leaders in at least six areas:
1. Make sure truly informed consent is a non-negotiable, integral part of any TNT/TLC program and consistent with the Belmont Report guidelines
2. Advocate for research--including full enrollment in the START trial--to definitively answer the "when to start treatment" question.
3. Speak out against criminalization and demand federal leadership on the issue.
4. Advocate that pharmaceutical companies withdraw from lobbying for the elimination of patient informed consent protections.
5. Support a renewed commitment to behavioral-based HIV prevention programs
6. Implement meaningful participation of people with HIV, including those with diverse opinions and perspectives, in the development, design and implementation of TNT/TLC programs."
I would add one more:
7. Government, academia, medicine and the HIV positive community should unite in a committed, appropriately funded campaign to educate the public about HIV in 2010 and the great progress that has been made in HIV medicine.

The public needs to know the good news.
Its good news that HIV is much easier to treat, that HIV drugs are less toxic and we are making progress further reducing their toxicities. It's good news many HIV positive persons can have reasonably healthy lives as a result of HIV therapy.

But much of the public knows little or nothing about this good news.

It's good news that effectively treated HIV positive patients are much less
infectious and perhaps in some instances noninfectious as I discussed in my essay "Vanquishing AIDS" for poz. Widespread knowledge of this fact could go along way to diminishing fear of HIV and the stigma that arises from that fear.

But this news be skillfully presented by public health authorities in the way that they see fit to so as not to diminish but rather reinforce the importance of safe sex, condom usage, abstinence and other effective prevention approaches.

It's good news that increased HIV treatment availability has the potential if done properly to have a strong public health preventative effect although Sean as you rightly point out this needs further scientific study.

Its good news that our public officials recognize the world of good that can come from increased HIV testing, earlier diagnosis and appropriate treatment and are developing new policies to improve access to testing and treatment.

I believe that when the public knows the facts on the ground about HIV and learns that we are collaboratively committed to ending HIV stigma and fully empowering and supporting HIV positive persons that will go a long way to facilitate the appropriate increased testing for HIV that public health officials are right to call for.

HIV testing needs to be initiated with what the United Nations calls the three C's, counseling, consent and confidentiality. For patients who test HIV positive treatment needs to be assessed on an individual basis in the context on a health care relationship that includes patient education, choice and empowerment.

Antiviral treatment is not presently curative and and has potential toxicities both known and unknown. Antiviral treatment should be initiated carefully and with care. Patient education, participation and choice is essential in the context of an ongoing patient centered health care relationship.

In my opinion, neither pharma or a government agency should be allowed to unduly influence that relationship and choice.

Our public health officials are indeed correct in their assessment that HIV treatment is getting better, safer and more effective and are right to want more people who could benefit from treatment on it. Their commitment to developing policies to achieve our shared goals is commendable and worthy of support. I believe that by working to together the concerns raised by Sean and the efforts of Dr. Mitchell Katz the SF Health Commissioner can be brought into alignment. Dr. Paul Curtis Bellman

You may be blessed not to have excess to drugs at this time. I am sorry that your State thinks so little of you and our Federal Government. I would be happy to share with you for one of my Bullet Points for Titration of Meds is that more resources would be available, if people where not over dosed in medicine or over prescribed with 8 different Scrips a month I take one pill a day from ADAP "Well Sometimes" and a very cutting edge nutrient program in Pill form. Write me at Frederick2010 at American on Line and lets chat.
2010 policy recommendations from GNP+USA
Implement PEP
Implement OTC Rapid HIV Screening KITS
Implement Titration of Drugs in Liquid Form for HIV People.

I do disagree with Mr Karmer for President Obama does care about Gay People and lets not forget HIV people too and the other Millions of People in America and surely his people are reading the next political move from the People with AIDS and HIV.

Hey, thanks, Juan Carlos!
Sean

well wheres the money going to come from, say you have 64,000 people on hiv meds in one state, i know treatment cost $13200 a year for just the drugs and that is for one person. thats 844,800,000.00 a year to treat them. We need the cure made public now!

This is a long blog to take in and remember all that was said. But there were things in there that may be a cause of a problem I have been having lately most likely from meds i havebeen taking for so many years and now it is catching up to my system. The vascular thing you brought out may be why i am having so many clots lately in the past three years. Used to the coumadin would keep them at bay but it seems that even at Inr beeing in the right mode of treatment i am still getting clots. I will mention this to both my doctors and see what they say.

i find that dr's are not for the patients anymore they are more for dispensing pills and being lazy and not stepping outside the box they protect their own more than patients right and when they stay in a hiv clinic too long they get a king or queen complex, and if you speak out you will be treated differently and denied some treatment, here in atlanta i see dr's letting things go and risking patients lives, i believe there needs to be an overhaul of the system here. before to many people have to pay the price for those risks, people stop depending so much on believing every word a dr says ask questions and demand answers its our lives that get effected by their mistakes, and i feel the medical teams act like the gestapo if you speak out against them , and they tend to refuse treatment if you do complain . i believe clinics should change out drs every few yrs so you avoid the god like complexes, ive been poz since 80's i seen the changes, yes meds are great but hiv/aids isnt cured and people are still dying. atlanta dr's do more preventative therapy dont wait til your patient is dying or damaged because you are lazy. if you cant do the job get out, thank you

another thing i believe dr's should have to answer for their medical mistakes legally and not be protected i see this happening more and more in hiv clinics, management encircle their own like a wagon train in western movies when they do , seems the patients rights dont count anymore , i ask for more accountability! before its to late

Thanks for the eye opening article. It is much appreciated.

It is clear that the health of people with HIV has become, for some, secondary to HIV prevention. Those of us with HIV are now viewed by much of the public health establishment primarily as potential infectors, "viral vectors of disease". >>>>>>>>>>>>>>THIS IS WHAT I GUESS I WAS TRYING TO SAY THAT IVE SEEN IN ACTION HERE IN ATLANTA OVER AND OVER AGAIN, SEEMS PEOPLE NEED TO FIND THEIR VOICES AND SPEAK LOUDLY AGAIN

and furthermore hiv dental clinics should also have to answer to medical unethical practices and abuse of patients rights , sometimes i believe review boards overlook hiv dental clinics because they are so few, but they to make mistakes that effect hiv patients rights, that can put hiv patients health at risk. they should answer to thier mistakes and thier bad judgements , as regular medical providers have to, because when you are dealing with immuno compromised patients neglecting some situations to long can be dangerous to hiv patients health, so lets have them go by ethics rules. speak out dont be afraid to make complaints, and dont live in fear of having treatment cutoff for speaking out....if your silent nuthing can be corrected!

i believe dr's should have to answer for their medical mistakes legally and not be protected i see this happening more and more in hiv clinics, management encircle their own like a wagon train in western movies when they do , seems the patients rights dont count anymore , i ask for more accountability! before its to late, same goes for hiv dental clinics to, because delaying or missing things can have a really adverse affect on any hiv patients health and lives! a pill isnt the cure and we as hiviers shouldnt live in fear of speaking out.

Okay here I go with my walk on reality crap again. If everyone does not know by now lets get it out of the way. I am HIV positive and I practice AIDS medicine as a primary care clinician. I see HIV with a lens not many do. It is both a good and bad vision quest. But bottom line for me is the fact that most of my new patients coming into my practice have been screwed over repeatedly by clinicians not skilled and educated enough in AIDS medicine and I am left with mopping up potentially life threatening mess of wrong drugs, poorly treated (if treated at all) side-effects, and patients that are justifiably pissed off. HIV is COMPLICATED medicine and the TNT scenario leaves me shuddering with poorly prepared clinicians lobbing toxic chemo (yes, everyone....daily ART IS daily chemotherapy) at people. This will blow up into a nightmare not even Larry Kramer can conceptualize.

I agree completely with Richard Ferri.

Over the past 20 years I have had problems with meds being prescribed improperly. I am currently on a very risky combo Raltegravir unboosted (I've had previous PI experience) along with two agents that I don't believe are fully active, as far as I can tell.

My objections fall on deaf ears. I was told I should take the meds "regardless of the side effects". Further suggesting non compliance.

It's good to know that AT LEAST one physician has voiced the truth.

This is ridiculously dangerous.

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This page contains a single entry by Sean Strub published on April 28, 2010 3:06 PM.

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