Patricia Nell Warren

President Obama: Expand Access to Generic AIDS Drugs

Filed By Patricia Nell Warren | August 28, 2013 2:30 PM | comments

Filed in: Living
Tags: AIDS drugs, Big Pharma, generic drugs, HIV, HIV/AIDS, Pfizer

President Obama has come under growing criticism that he isn't doing enough to fight AIDS. Not surprisingly, Obama is finally responding to the charges. On July 15, he issued an executive order calling for better coordination of the AIDS fight here in the U.S. He insisted, "Addressing the domestic HIV epidemic is a priority of my administration."

To do this, Obama has mandated the establishment of a working group that must report back to him in 180 days on how better to coordinate and improve the "HIV care continuum." And he recommends HIV screening as a part of routine care for all individuals aged 15 to 65 -- a requirement that has stirred up protest in some quarters.

Testing controversy aside, what exactly could be better coordinated? How about the President's 2011 campaign promise to keep pharmaceutical companies from conspiring to make generic drugs inaccessible to U.S. consumers? His promise: "Lower drug costs by allowing the importation of safe medicines from other developed countries, increasing the use of generic drugs in public programs, and taking on drug companies that block cheaper generic medicines from the market." This would include generics used in HIV treatment.

Looking at the Scorecard

So how has the President performed on the generic-drugs front?

Since 2011 there's been a bill kicking around in the Senate -- the Affordable Generics Act -- that would authorize the FTC to hammer any company that "agrees to limit or forego research, development, manufacturing, marketing, or sales of [a] generic drug for any period of time." With their medical bills spiraling out of control, the American people want and need generics as never before. But the AGA bill appears stuck, and the knothead House is not considering a similar bill. The White House hasn't made a lot of noise about supporting the measure, to help stir up public pressure on legislators and end the gridlock on this bill.

In October 2012, the Obama administration did ask the U.S. Supreme Court to rule on this issue of "pay-to-delay" deals in the drug industry, to clarify whether the government has the right to restrain trade in this manner. In June 2013, the high court gave a green light to FTC action on this front.

drugs.jpgBut meanwhile, paradoxically, even as the U.S. Supreme Court supported protection for generics development at home, we see the President actually siding with Big Pharma on foreign-made generics, including those used in AIDS treatment. During his recent visit to India, I was disturbed to see Obama asking the government of India to put the brakes on its generic pharmaceutical industry. This after the huge fight, some years ago, to get Indian-made generic AIDS drugs into the global marketplace over pharmacorp objections, because these ARVs are the most affordable for cash-strapped developing countries.

The fact is, American-made generic ARVs are usually far more expensive than generic ARVs made abroad. According to a Huffington Post report:

"About 98 percent of the drugs purchased by President George W. Bush's landmark PEPFAR AIDS relief program are generics from India. Before Indian companies rolled out generic versions priced at $1 a day, AIDS medication cost about $10,000 per person per year. But India's generic industry has also cut into profits for Pfizer and other U.S. and European drug companies. In response, these companies have sought to impose aggressive patenting and intellectual property standards in India, measures that would grant the firms monopoly pricing power over new drugs and lock out generics producers."

Dangers of Lobbying

Not surprisingly -- in the case of Pfizer, for instance -- we can draw a straight line from Pfizer's complaints about India to Pfizer's efforts to lobby the Obama administration. As Open Secrets, Inc. puts it: "Pfizer is one of the biggest players in what is widely considered the most influential industry in Washington: pharmaceutical manufacturers." According to figures available to the public, Pfizer spent far more on lobbying Obama during the campaign ($126,951 in 2011) than it did on lobbying Romney ($58,775 in 2011).

Sad to say, key figures in Congress are heavily lobbied by Pfizer and other companies, and support the President's hostility towards affordable foreign-made drugs.

In the Obama executive order, I don't see any mention of the value of generic AIDS drugs, or concerns about cost of treatment. The FDA lists 31 generics that are currently approved for HIV treatment and marketed in the U.S. Some are made by Indian companies like Cipla. According to AidsMap last year,

"Using two generic HIV drugs plus one branded one in the most popular first-line regimen instead of using all three in a single-pill fixed-dose combination would save $4000 per quality-adjusted year of life (QALY) for each individual on treatment in the USA, and would save the country $920 million on its annual drugs bill, the 19th International AIDS Conference was told yesterday. These estimates were arrived at by Rochelle Walensky and colleagues from Harvard Medical School, using a mathematical model called the Cost-Effectiveness of Preventing AIDS Complications in the US (CEPAC-US) model."

Whither the Working Group?

More HIV testing means (presumably) more people treated for HIV -- meaning more ARVs sold by pharmaceutical companies. The sum of $920 million a year saved on treatment expenditures would make generics a worthwhile investment for Obama's HIV Care Continuum Initiative. But will generics be on the working group's short list when they report back in 180 days? I wonder.

The working group has been ordered by the President to: "identify potential impediments to improving outcomes along the HIV care continuum, including for populations at greatest risk for HIV infection..." I would say that decreased use of generic drugs would qualify as a "potential impediment" to "improving outcomes." The higher cost of using non-generic ARVs will tend to limit the number of persons treated, especially those who (in spite of Obamacare requirements) won't have insurance, can't afford treatment, and don't qualify for programs offering free treatment. I wonder if the working group will dare to swim upstream against the President's emerging anti-generics policy and come up with a solution for this problem.

If the Obama administration intends to be serious about better coordination of HIV treatment, the President will have to resist the lobbying pressure of Big Pharma, who would be deliriously happy if they could make generics go away. According to the CDC, the average annual cost of HIV treatment and care is now $23,000 (in 2010 dollars), and that doesn't include the cost of managing side effects of drugs and AIDS-related conditions.

I won't be surprised to see the annual cost soaring far higher if generics are left by the side of the road.

For further reading:
Obama Executive Order on HIV Care Continuum

FDA list of generic drugs

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