Tim Barrus/ Wake up, America.

We can’t get the medication to people who are infected.

Public policy has been constructed around a disease where the operant theory contains scenarios where if people being treated go untreated, the virus mutates.

It becomes more virulent. And what medications you do have access to become less and less effective. You begin to develop different strains where those main stream culture stigmatizes as bad people have bad strains, and then there will always be the uninfected tax payers who are straining to support a system they have voted for, educated their children for and created themselves that is unsustainable.

No one can afford these drugs. Now we have waiting lists for drugs no one can buy without government assistance that is evaporating right before our eyes.

A grinding genocide.

I have been screaming for a long time now that the cupboards will go bare — first, for all the wrong people. You know, the poor ones.

I get many reactions from the wealthier people about my inappropriate anger.

“He’s too militant. ”

Can you imagine these same people walking into the drugstore but there’s no medication for them.

It will never happen. It’s unthinkable.

Antiretroviral drugs used in the treatment of HIV infection.

Fair Trade Agreements don't feel very fair if you happen to have HIV/AIDS and not a lot of money - like kids around the world. Or adolescents. Women. Men, even.  Basically for millions of human beings who happen to be infected with HIV and find it incredibly difficult to access the medications, let alone afford the medications.

It is incredibly stressful to be made aware through all the magnificent HIV/AIDS awareness and prevention campaigns that taking appropriate antiretrovirals, and consistently, will extend your life or the life of someone you care deeply for because you love them, care about them as a friend or work colleague, or know them because their life has touched yours in today's social networking forums. Antiretrovirals also reduce a person's infectiousness and chances of transmitting the virus to someone else. It is incredibly stressful owning this knowledge and being denied access  to the medications, because you happen to live in the wrong place or happen to be too poor to buy the pills.

• 92 percent of people living with HIV on treatment in low- and middle-income countries currently use generic antiretroviral (ARVs), mostly manufactured in India;  U.S. programs to provide AIDS medicines overseas rely on Indian generics as well. The European Union is pushing India to adopt laws that will undermine generic production.
• President-elect Barack Obama made a strong statement backing countries’ rights to buy affordable generics and promised to “break the stranglehold that a few big drug and insurance companies have on these life-saving drugs.”
• The wealthy countries are largely doing the bidding of the pharmaceutical industry that seeks to keep prices high. Even in developing countries, health concerns are underrepresented in these negotiations.  Trade agreements are not negotiated by health ministers, but by trade ministers, advised by powerful commercial interests.  Their goal is access to foreign markets. They are often quite content to trade away health considerations.

It makes for good common sense public health policy to find a solution.

Antiretrovirals reduce a person's infectiousness and thereby his/her risk of transmitting the virus to another human being, both within and beyond his/her home. It therefore seems remarkably sensible for Global Public Health Policy Makers and Implementers to distribute appropriate and consistent supplies of antiretrovirals to the people, who happen to be infected with the Human Immunodeficiency Virus (HIV) and who happen to be living with their borders; as well as for those of their neighbours. People actively cross borders everyday for trade, tourism and a myriad of other reasons. HIV travels.  HIV does not discriminate; anybody no matter his/her age, race or religion can be infected or affected by HIV.

The pharmaceutical industry take out patents to cover the costs they spend on the research and development and marketing for their drugs to be sold in great quantities at the highest price they can secure. Theirs is a business, not philanthropy.  The general idea is to make a profit; to cover their set up costs and pay their workers, as well as plough back into new research and development for new drugs. Pharmaceutical companies will not take the risk of getting involved in new research and development for new HIV drugs (or for a CURE) unless they feel they will make enough money. And they most likely feel very irked when people pirate their patented creations and products.

Today a huge amount of money is being spent lobbying and challenging and fighting the pirating of drug patents and manufacturing. Today a huge amount of valuable time for people who are eager to extend their lives and reduce their infectiousness, is being wasted. The tension is active and does not benefit those who need the medications created, and for whom the medications were created and are being manufactured.

Extraordinary human suffering has given rise to extraordinary human ingenuity and the creation of today's antiretrovirals.

Extraordinary human foresight will be achieved if Pharmaceutical Leaders (who own the drug patents), disclose how much it has cost them to bring their patented HIV drugs to the global marketplace, and Global Public Health Policy Leaders reimburse them for their costs and negotiate an agreed amount for their particular antiretroviral pills to be manufactured. It will be a substantial sum of money.

Today it is estimated there are 30 million people who could benefit from taking antiretrivorals on a daily basis. If each pill cost $2 that would make $60 million ($1 for production; $1 for profit). $30 million per day = a lot of millions of dollars a year.

 

Drugs Used in the Treatment of HIV Infection

Click on drug brand name for additional information.  Multi-class Combination Products

Brand Name	Generic Name	Manufacturer Name	Approval Date	Time to Approval
Atripla	efavirenz, emtricitabine and tenofovir disoproxil fumarate	Bristol-Myers Squibb and Gilead Sciences	12-July-06	2.5 months

Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Brand Name	Generic Name	Manufacturer Name	Approval Date	Time to Approval
Combivir	lamivudine and zidovudine	GlaxoSmithKline	27-Sep-97	3.9 months
Emtriva	emtricitabine, FTC	Gilead Sciences	02-Jul-03	10 months
Epivir	lamivudine, 3TC	GlaxoSmithKline	17-Nov-95	4.4 months
Epzicom	abacavir and lamivudine	GlaxoSmithKline	02-Aug-04	10 months
Hivid	zalcitabine, dideoxycytidine, ddC (no longer marketed)	Hoffmann-La Roche	19-Jun-92	7.6 months
Retrovir	zidovudine, azidothymidine, AZT, ZDV	GlaxoSmithKline	19-Mar-87	3.5 months
Trizivir	abacavir, zidovudine, and lamivudine	GlaxoSmithKline	14-Nov-00	10.9 months
Truvada	tenofovir disoproxil fumarate and emtricitabine	Gilead Sciences, Inc.	02-Aug-04	5 months
Videx EC	enteric coated didanosine, ddI EC	Bristol Myers-Squibb	31-Oct-00	9 months
Videx	didanosine, dideoxyinosine, ddI	Bristol Myers-Squibb	9-Oct-91	6 months
Viread	tenofovir disoproxil fumarate, TDF	Gilead	26-Oct-01	5.9 months
Zerit	stavudine, d4T	Bristol Myers-Squibb	24-Jun-94	5.9 months
Ziagen	abacavir sulfate, ABC	GlaxoSmithKline	17-Dec-98	5.8 months

Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Brand Name	Generic Name	Manufacturer Name	Approval Date	Time to Approval
Intelence	etravirine	Tibotec Therapeutics	18-Jan-08	6 months
Rescriptor	delavirdine, DLV	Pfizer	4-Apr-97	8.7 months
Sustiva	efavirenz, EFV	Bristol Myers-Squibb	17-Sep-98	3.2 months
Viramune	nevirapine, NVP	Boehringer Ingelheim	21-Jun-96	3.9 months

Protease Inhibitors (PIs)

Brand Name	Generic Name	Manufacturer Name	Approval Date	Time to Approval
Agenerase	amprenavir, APV	GlaxoSmithKline	15-Apr-99	6 months
Aptivus	tipranavir, TPV	Boehringer Ingelheim	22-Jun-05	6 months
Crixivan	indinavir, IDV,	Merck	13-Mar-96	1.4 months
Fortovase	saquinavir (no longer marketed)	Hoffmann-La Roche	7-Nov-97	5.9 months
Invirase	saquinavir mesylate, SQV	Hoffmann-La Roche	6-Dec-95	3.2 months
Kaletra	lopinavir and ritonavir, LPV/RTV	Abbott Laboratories	15-Sep-00	3.5 months
Lexiva	Fosamprenavir Calcium, FOS-APV	GlaxoSmithKline	20-Oct-03	10 months
Norvir	ritonavir, RTV	Abbott Laboratories	1-Mar-96	2.3 months
Prezista	darunavir	Tibotec, Inc.	23-Jun-06	6 months
Reyataz	atazanavir sulfate, ATV	Bristol-Myers Squibb	20-Jun-03	6 months
Viracept	nelfinavir mesylate, NFV	Agouron Pharmaceuticals	14-Mar-97	2.6 months

Fusion Inhibitors

Brand Name	Generic Name	Manufacturer Name	Approval Date	Time to Approval
Fuzeon	enfuvirtide, T-20	Hoffmann-La Roche & Trimeris	13-Mar-03	6 months

Entry Inhibitors - CCR5 co-receptor antagonist

Brand Name	Generic Name	Manufacturer Name	Approval Date	Time to Approval
Selzentry	maraviroc	Pfizer	06-August-07	8 months

HIV integrase strand transfer inhibitors

Brand Name	Generic Name	Manufacturer Name	Approval Date	Time to Approval
Isentress	raltegravir	Merck & Co., Inc.	12--Oct-07	6 months

 

Generic drugs used in the Treatment of HIV Infection

Drugs Used in the Treatment of Pediatric HIV Infection

Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan (PEPFAR)

 

Bill Gates (interview with Charlie Rose, Feb. 11 2011)

There will not be a cure for AIDS until people in specifically the United States begin to understand that it didn’t go away. It’s still out there. Countries in the southern part of Africa still have the worst part of the pandemic. We can’t get medications to all these people. Americans have convinced themselves that AIDS no longer means them. Until it means them, there will be no cure, and millions of people are going to die.

 

HOME by Berry Bickle (2010) - Black Armbands of Mourning

 

The gift of L.I.F.E.

(longevity.increase.for.everyone)

Where are our aunts and uncles, our brothers and sisters, our religious and community leaders and presidents and kings and queens, where are our FRIENDS, role models and teachers, where are our guides and warriors. Hundreds of Millions of children, adolescents, women and men are TODAY suffering because a socially transmitted retrovirus is affecting minds and bodies. Human minds and Human bodies. We have the technologies. We have the ingenuity. We have the wealth. PASSION and DESIRE will ignite the Call for a Cure.  Please join us all and everywhere.

 

"It's A Green Light." by Tim Barrus

 

International AIDS Society (IAS)

The 2011 Rome Statement for an HIV Cure.

Please add your name to the Call for HIV Cure Research to be Accelerated.

 

The 2011 Rome Statement for an HIV Cure.

The year 2011 marks 30 years since the first AIDS cases were reported. During these three decades significant progress has been made in the global response against the HIV/AIDS epidemic. In particular, development of efficient antiretroviral drugs and their expanding availability have ensured that millions of people living with HIV live a healthy life. Today, more than six million people from low-and-middle-income countries receive antiretroviral treatment , a more than 10-fold increase in less than a decade.

Nevertheless, while the benefit of antiretroviral treatment is irrefutable, the maintenance of a persistent infection in patients despite years of antiretroviral therapy precludes any discontinuation of treatment. This life-long requirement is both an individual and public health burden. In addition, for every person starting antiretroviral treatment, two new infections occur . In a context of global economic crisis with the resulting pressure on international funding of the HIV/AIDS response, the long-term sustainability of treatment rollout is in jeopardy. The recent change in the WHO guidelines recommending an earlier initiation of HIV treatment makes the situation even more challenging. Investments to develop new therapeutic strategies that will ultimately allow HIV infected patients to discontinue their treatment are of the utmost urgency.

Recent scientific advances in HIV research have led to a re-emergence of interest and optimism in the prospects of a cure for HIV. The development of, at least, a functional cure that, without completely eliminating the virus from the body, would permanently suppress its replication and considerably diminish viral reservoirs, possibly leading to the long-term remission of patients. Not only would such a strategy act as therapy at the individual level but, considering the growing evidence that HIV transmission is dramatically reduced in the absence of detectable viral load, it would most probably contribute to HIV prevention at the population level. Nevertheless, these efforts should come in addition to the current treatment rollout and prevention strategies.

A functional HIV cure can only be achieved through an increased and concerted international effort engaging not only the scientific community but all stakeholders involved in the HIV/AIDS response and global health.

Under the auspices of the International AIDS Society, a group of internationally recognized scientists and stakeholders is guiding the development of a global scientific strategy “Towards an HIV Cure”. The strategy aims at building a global consensus on the state of the HIV reservoirs research and defining scientific priorities that need to be addressed by future research to tackle HIV persistence in patients undergoing antiretroviral therapy.

As members of the Advisory Board of the Towards an HIV Cure:

• We recognize the importance of developing a safe, accessible and scalable HIV cure as a therapeutic and preventive strategy against HIV infection and to help control the AIDS epidemic.
• We are committed to stimulating international and multidisciplinary research collaborations in the field of HIV cure research.
• We encourage other stakeholders, international leaders and organizations to contribute to accelerating HIV cure research through their own initiatives and/or by endorsing this statement and supporting the alliance we are building.
• Now, more than ever, it is time to seriously start looking for an HIV cure.

Founding Signatories:

Advisory Board Members – Global Scientific Strategy “Towards an HIV Cure”:

Bertrand Audoin, International AIDS Society
Craig McClure, World Health Organization
Françoise Barré-Sinoussi, International AIDS Society
Jack Whitescarver, United States National Institutes of Health
Jean-François Delfraissy, French Agence Nationale de Recherche sur le Sida et les Hépatites Virales
Mark Harrington, Treatment Action Group
Nikos Dedes, International Treatment Preparedness Coalition
Paola de Carli,Sidaction
Paula Munderi, MRC/UVRI Uganda Research Unit on AIDS.
Rowena Johnston, amfAR, The Foundation for AIDS Research

International Working Group Members – Global Scientific Strategy “Towards an HIV Cure”:

Alain Lafeuillade, Toulon General Hospital, France
Alan Landay, Rush University Medical Center, USA
Amalio Telenti, University of Lausanne, Switzerland
Ann Woolfrey, Fred Hutchinson Cancer Research Center, USA
Ben Berkhout, University of Amsterdam, The Netherlands
Carine Van Lint, University of Brussels, Belgium
Christine Katlama, Pitié-Salpêtrière Hospital, France
David Margolis, University of North Carolina at Chapel Hill, USA
Eric Verdin, University of California, San Francisco, USA
Frank Maldarelli, NCI/NIH, USA Guido Poli, San Raffaele University and Scientific Institute, Italy
Guido Silvestri, Emory University School of Medicine, USA
Javier Martinez-Picado, Foundation Germans Trias I Pujol for Biomedical Research, Spain
Jean-Pierre Routy, McGill University, Canada
Jim Mullins, University of Washington, USA
John Mellors, University of Pittsburgh, USA
John Zaia, Beckman Research Institute of City of Hope, USA
Mario Stevenson, University of Miami Medical School, USA
Martin Markowitz, Aaron Diamond AIDS Research Center, USA
Melissa Churchill, Burnet Institute, Australia
Michael Lederman, Case Western Reserve University, USA
Michele Di Mascio, NIAID/NIH, USA
Nicolas Chomont, VGTI- Florida, USA
Sarah Palmer, Karolinska Institute, Sweden
Sharon Lewin, The Alfred, Monash University and Burnet Institute, Australia
Steven Deeks, University of California, San Francisco, USA

Statement Supporters

David Haerry. European Aids Treatment Group
Stefano Vella, Istituto Superiore di Sanita, IAS 2011 Co-Chair

 

President Barrack Obama (July 2010)

National HIV/AIDS Strategy

The Federal government can’t do this alone, nor should it.  Success will require the commitment of governments at all levels, businesses, faith communities, philanthropy, the scientific and medical communities, educational institutions, people living with HIV, and others. Bridging the gap in access to HIV medications: Over the past year, a growing challenge has arisen as an increasing number of people living with HIV are placed on waiting lists for state operated AIDS Drug Assistance Programs (ADAP). 

 

Tina Rosenberg/ NY Times: A Trade Barrier to Defeating AID

In Friday’s Fixes column, I wrote about the Medicines Patent Pool, a new organization trying to make AIDS drugs better, cheaper and available sooner to people who need them in poor countries.   It relies on voluntary donations of rights by patent holders, most of them pharmaceutical companies.   Its success is crucial; new research shows that if we can dramatically increase the number of people on antiretroviral medicines, we can not only save millions of lives, but potentially cause the epidemic to die away.

Earlier this month, the patent pool received its first donation of rights from a pharmaceutical manufacturer, Gilead Sciences.   It is an important step  — but the terms Gilead negotiated are also confirmation of a dangerous new trend: middle income countries as a target market for drug makers.  In the past, pharmaceutical companies have lowered prices in these countries to increase sales.  The new strategy is to treat people in Egypt, Paraguay, Turkmenistan or China — middle-income countries, all — as if they or their governments could pay hundreds or even thousands of dollars a year each for AIDS drugs.   This low-volume high-profit strategy might make  business sense.   But in terms of the war against AIDS, it means surrender.

In the world’s most impoverished countries, AIDS drugs are cheap.   It wasn’t always that way.  Until well into the Clinton administration, the United States government pressured even the poorest countries shamelessly if they tried to bring down the prices of medicine.   Even newly democratic, AIDS-ravaged South Africa became the object of an all-out assault by the Clinton administration to get the country to repeal a law allowing it to break medical patents, a step that was perfectly legal under world trade rules.  Washington was not interested in the health consequences.   (A U.S. trade negotiator who worked on South Africa at the time told me that he had been unaware that AIDS was a major problem there.)    Public outrage over South Africa ended Washington’s pressure on poor countries.   In 2000, President Clinton issued an executive order pledging that sub-Saharan African countries would not face trade sanctions for laws promoting access to AIDS medicines.

The order continues to be largely respected, and the group of countries who are generally able to get access to the cheapest drugs has grown to include the poorest countries from around the world — Afghanistan, Tajikistan, Bangladesh, Burma.    Gilead’s agreement with the Medicines Patent Pool covers these countries.

But countries just above this cutoff line are on their own.  “There are countries that are considered to be “middle income” that will never be able to afford the high prices charged by innovative pharma companies,” said reader A. Grant of New York.  These nations are also losing the discounts that major manufacturers of AIDS drugs used to offer them.  According to Médecins Sans Frontières, which tracks drug prices, prominent manufacturers of AIDS drugs have stopped offering discounts to middle-income countries, or now require that countries negotiate those discounts one by one.

Yet another assault on middle-income countries’ ability to buy drugs comes in the form of trade deals.   The ongoing negotiations for a free trade agreement between the European Union and India is particularly crucial, as India is drug maker to the world — 92 percent of people taking antiretroviral medicines in developing countries use generic medicines made in India;  U.S. programs to provide AIDS medicines overseas rely on Indian generics as well. The European Union is pushing India to adopt laws that will undermine generic production.

India is fighting back — in part because the generic drug industry is so strong.  But this is a rare case of power being on the side of public health.  The wealthy countries are largely doing the bidding of the pharmaceutical industry that seeks to keep prices high.  Even In developing countries, health concerns are underrepresented in these negotiations.  Trade agreements are not negotiated by health ministers, but by trade ministers, advised by powerful commercial interests.   Their goal is access to foreign markets.  They are often quite content to trade away health considerations.

The United States was supposed to have abandoned this approach. President-elect Barack Obama made a strong statement backing countries’ rights to buy affordable generics and promised to “break the stranglehold that a few big drug and insurance companies have on these life-saving drugs.”  In addition, on May 10, 2007, Congress and President Bush agreed to standards for trade agreements that, among other things, protect the right to access to medicines.

But the Office of the United States Trade Representative does not see it that way.  The office is now negotiating a new free trade agreement, the Trans-Pacific Partnership Agreement, with eight other countries.Inside U.S. Trade reported that at a briefing this May, a U.S. trade official said that the office does not intend to respect the May 10 agreement.   “2007 is 2007 and 2011 is 2011,” the official reportedly said.

“Companies are finding new ways to be aggressive about protecting pharmaceutical monopolies that haven’t been in past free trade agreements,” said Peter Maybarduk, the global access to medicines program director at Public Citizen.  Leaked drafts of the trade office’s negotiating proposals  for the Trans-Pacific agreement show that Washington has proposed eliminating formal ways that patents can be challenged before their registration and proposed measures to lower the standards for what can be patented — for example, allowing companies to extend their monopolies by making minor modifications in a product, whether or not they lead to improved results.   According to Inside U.S. Trade, trade office officials have said they would likely follow what the pharmaceutical industry wants on the extremely controversial issue of data exclusivity — rules that discourage generic production by keeping data proprietary, requiring generic manufacturers to re-do clinical trials. (Reader Edward Low of Kuala Lampur) noted that one medicine became 845,600 percent more expensive in Guatemala after the country signed a free trade agreement with the United States.   This is, bizarrely enough, true — data exclusivity was the culprit.)

A U.S. trade official told me that its proposals on data exclusivity are not yet set, but that Washington’s  goals in the agreement are “predictability and transparency” on drug prices.

Countries that take measures to lower drug prices also often find themselves on the trade office’s Special 301 Watch List, a precursor to sanctions.   Brazil, India and Thailand, among other countries, are on the lists for insufficient protection for intellectual property — even though their measures are fully within international trade law.

The list of people worried about the terms of U.S. trade agreements contains some unusual suspects.  Last year, the then-governors of Vermont and Maine wrote to the Obama administration protesting what they saw as a particularly dangerous part of past free trade agreements:  language that restricts government-run pharmaceutical pricing programs.   Trade agreements with Australia and Korea contain these clauses.  If Washington proposes the same thing in the Trans-Pacific agreement, it will be applying this policy to countries that are much poorer, including Vietnam, Malaysia, Chile and Peru.  In addition, the introduction to the Watch List cites several countries for using a government’s negotiating power to buy cheaper medicine.

Why would this bother these governors?  Because this is exactly what states and the federal government do in America.  They negotiate big discounts on the medicines they buy for Medicare Part B and Medicaid.   Without those discounts, those programs could not survive.  The Veterans Administration and the Pentagon, among other agencies, do the same thing. “Trade agreements, are, of course, reciprocal by nature,” wrote the governors, John Baldacci of Maine and James Douglas of Vermont.   Washington argues that the fine print exempts U.S. programs — in the Korea agreement, this argument was explicit.  It is difficult to decide what’s worse: the chutzpah of telling a poorer country that it can’t negotiate lower prices while the United States can, or allowing pharmaceutical company lobbying to result in the destruction of a substantial slice of American health care.

The pharmaceutical industry is seeking to take this a step further.  The chief executive of Pfizer, Jeff Kindler, and the late John Barton, a Stanford University Law professor, proposed a global agreement on pharmaceutical prices that would, among other things, severely restrict the ability of wealthy and middle income countries anywhere to use such pharmaceutical pricing programs.  Ambassador Ron Kirk, the U.S. Trade Representative, has said the idea deserves consideration. 

Tim Barrus responds:

In the AIDS game, it’s about the good, the bad, and the ugly. The tragedy is that for some of us, it’s not a game. We’re fighting for our lives. I am. There is a bottom line to the game of lists. Trade agreement lists. Big Pharma lists. AIDs-related disease lists. Medication lists. The poor list. The middle list. The rich list. The lists create the illusion that you care. There is the me list. There is the you list. We are not the same. All of the funding, all of the research, all of the games, all of the AIDS walks, all of the profit-making, all of the medications, all of the science has produced very little outside the context of temporary measures. The you can hold it off list. But you can’t hide from it list. Yet Ms. Rosenberg sees hope. There is the silly hope list. Silly you. The hope we can end the pandemic list. You can always find hope lurking in the bone marrow of the oddest places. There is the bottom line list, too. TRY to see it from the perspective of someone WITH the disease just once. There is scant evidence to suggest anyone cares enough to find a cure. In fact, you have given up. There’s the me, too, list. I have given up. The idea of a cure is laughable. This is an excellent article. Except for the pie in the sky bit about hope. Trade agreements aren’t about hope. They’re about the rich list and their right to make more money. They need money, the rich. It’s never enough. We are a market to them. Period. There is always hope for the rich.  The hope that they can make more money list. Trade agreements control those strings, too. The rich just pull them. There is the haves list; have nots. But there is no hope list outside illusion, fantasy, and death. The US now has lists of people who can’t get the meds. But we care but we care. No, you don’t. That is the we pretend to care list. It’s a list your denial does not care to read. I have a list. It’s my the rich will die someday, too, list. The Your Day will come list. Until then, keep writing lists.