AHF Lauds Rep. Alcee Hastings for Congressional Letter Cautioning Gilead On Pricing of New AIDS Drug

One dozen Members of Congress cosign letter to Gilead CEO John C. Martin writing they are “troubled” by media reports indicating Gilead may charge thousands more than exisitng AIDS drugs for its latest HIV/AIDS drug known as the ‘Quad;’ Congressmembers urge Gilead “…to consider sustainable pricing strategies for its products that would help… provide treatment to as many individuals as possible.”

Research suggests Gilead’s new once-daily, four-drug HIV/AIDS pill represents only a marginal improvement over existing medications, but is expected to come with steep commercial price tag

WASHINGTON (August 16, 2012) — AIDS Healthcare Foundation today lauded United States Representative Alcee L. Hastings (D, FL 23rd Congressional District) for a letter he wrote—and which a dozen of his fellow Members of Congress cosigned—to Gilead Sciences’ CEO John C. Martin in which the Congressmembers state they are “troubled” by media reports indicating Gilead may charge may charge thousands more than exisitng AIDS drugs for its latest HIV/AIDS drug known as the ‘Quad.’ In the letter, the Congressmembers also urge Gilead “…to consider sustainable pricing strategies for its products that would help allow ADAP to provide treatment to as many individuals as possible.” 

Fellow Congressional cosigners of the letter to Gilead urging restraint on HIV/AIDS drug pricing include: Eleanor Holmes Norton, (D, Washington, DC); Corrine Brown (D, FL 3rd District); Sam Farr (D, CA 17th District); Luis V. Guttierez (IL 4th District); Maxine Waters (D, CA 35th District); Lynn C. Woolsey (D,CA 6th District); Janice D. Schakowsky (D, IL 9th District); Raul M. Grijalva (D, AZ 7th District); Maurice D. Hinchey (D, NY 22nd District); Lucille Roybal-Allard (D, CA 34th District); Debbie Wasserman Schultz (D, FL 20th District) and Ted Deutch (D, FL 19th District).

In the letter, dated August 1, 2012, the Members of Congress wrote:

“As Members of Congress who are committed to ensuring access for people living with HIV/AIDS to lifesaving treatment, we write to express our concern regarding the implications of Gilead’s recent price increases for certain antiretroviral drugs in the commercial market on our nation’s AIDS Drug Assistance Program (ADAP). It is our understanding that, while Gilead currently has a price freeze in effect through 2013 for drugs provided to ADAP, the price of HIV/AIDS drugs in the commercial market have indirectly exacerbated the ongoing ADAP funding crisis. In addition, we are troubled by media reports that indicate that Gilead may charge as much as $34,000 for its new drug, known as the “Quad,” in the commercial market. … Therefore, we urge Gilead to consider sustainable pricing strategies for its products that would help allow ADAP to provide treatment to as many individuals as possible.”

“Recent news reports place Gilead CEO John Martin as the tenth highest paid CEO in America, with reported earnings of over $53 million last year. We applaud and thank Representative Hastings and his fellow Members of Congress for acknowledging Gilead’s contributions to the fight against HIV/AIDS over the years, but also writing directly to Mr. Martin to urge him that Gilead now show some restraint as it prices the Quad when bringing it to market later this year,” said Michael Weinstein, President of AIDS Healthcare Foundation. “It would be unconscionable—but, sadly, not entirely unexpected—if Gilead priced the Quad higher than similar drugs already on the market, particularly when the Quad is only a marginal improvement over other existing medications. In the long run, the cost to Gilead to actually produce the Quad will be a small fraction of its selling price, which means Gilead can show restraint on Quad pricing and still make an enormous profit.”

In closing the letter to Martin, Hastings and his fellow Congress Members wrote:

“We greatly appreciate Gilead’s continued commitment to developing new, more efficacious drugs for people living with HIV/AIDS. … It is our sincere hope that Gilead will support our nation’s ADAP by considering sustainable HIV/AIDS drug pricing in the commercial market—particularly for the Quad—, as well as supplemental price reductions and rebates, that bolster the ability of ADAPs nationwide to provide lifesaving drugs to all those in need. Thousands of people living with HIV/AIDS are depending on it…”

“Recent news reports place Gilead CEO John Martin as the tenth highest paid CEO in America, with reported earnings of over $53 million last year. We applaud and thank Representative Hastings and his fellow Members of Congress for acknowledging Gilead’s contributions to the fight against HIV/AIDS over the years, but also writing directly to Mr. Martin to urge him that Gilead now show some restraint as it prices the Quad when bringing it to market later this year.” 

Background on the ‘Quad’

According the New York Times (AIDS: New Four-Drug Pill Taken Daily Tests Better Than Other Regimens, by Donald G. McNeil, Jr., July 2, 2012): “A new once-a-day pill combining four AIDS drugs has proved slightly better than two existing once-a-day regimens, according to studies published in The Lancet last week. The new pill, called Quad, had roughly the same side-effects rate, though some were different. For example, it appeared to cause more nausea but fewer rashes than Atripla, a common three-drug pill. It appeared to cause more kidney problems than a four-drug two-mix pill, but fewer patients stopped taking it.”

The ‘Quad’ will hit the market later this year and will likely be priced nearly two times as much as the most expensive drug that state AIDS Drug Assistance Programs (ADAPs) purchase, without representing a significant improvement over existing medications. State ADAPs—which provide lifesaving HIV/AIDS medications to low-income Americans—are facing a funding shortage. As of August 9, 2012, there were 1,125 individuals on ADAP waiting lists in seven states, according to ADAP Watch, a publication of the National Alliance of State and Territorial AIDS Directors (NASTAD). Rising drug prices are a key contributor to the current ADAP crisis—the program simply cannot afford to provide medicines to an increasing number of people in need.

In June, AHF’s call for Gilead to price the Quad reasonably was echoed by California State Treasurer Bill Lockyer who sent a letter to the California-based Gilead urging the company to set an initial price the “Quad” that is “…sensitive to ongoing state budget difficulties,” and which will also “…provide the means to keep people with HIV/AIDS alive and as healthy as possible.” In his letter dated June 18, 2012 and addressed to Gilead CEO John Martin, Treasurer Lockyer also stated:  “…I hope that Gilead will get ahead of the drug pricing curve and set a price for the Quad that will help to protect the financial integrity and security for the ADAPs in California and elsewhere.” 

The sharp increases in AIDS drug costs are fueled by the skyrocketing prices of each new generation of drugs. By law, ADAP drug prices for existing drugs cannot increase more than inflation. However, there are no restrictions on the price charged for new drugs. The companies have exploited this fact, increasing the price of their new products by tens of thousands of dollars in order to offset the discounts they must provide to ADAPs and other programs. 

This trend could not be clearer: Since 1995, the average price of new AIDS drugs has increased 163%.

The ‘Quad’

Currently, there are several drugs in development that will pose a huge threat to ADAPs if they are priced higher than the current generation of antiretrovirals. Chief among them is Gilead Sciences’ so-called ‘Quad’. The Quad combines Truvada with Elvitegravir (an integrase inhibitor similar to Merck’s Isentress) and Cobicistat (a blood booster similar to the decade-old Norvir). The FDA is currently reviewing Gilead’s application to approve the Quad, but it is expected to hit the market sometime this year. The Quad may end up costing nearly two times as much as the most expensive drug ADAP purchases, and in some cases three or four times as much as other drugs.

Support, Don’t Punish, Our Youth

Drug laws established to protect youth too often present the greatest danger to young people, who suffer imprisonment, harassment and marginalization. The emerging discourse on drug policy reform needs to incorporate the experiences of young people who use drugs – because, for too long, the rhetoric has not reflected their reality.

In the Middle East, Central Asia, Southeast Asia and Africa, Youth RISE continues to see too many young people who use drugs stigmatized and isolated. They experience severe human rights abuses, a lack of health services and appropriate treatment, in addition to being barred from education and employment.

In Nigeria, young people who use drugs are increasingly at risk of what appears to be a growing HIV epidemic among young users. This is driven by high-risk drug using behavior, a consequence of drug polices based on criminalization and subsequent persecution and social stigma. Research by Youth RISE our members in Nepal has shown the major barriers young people experience in accessing drug and HIV prevention services. Unjust harassment and persecution by police officials is also commonly experienced in Lebanon. Here, Youth RISE members have facilitated workshops at a women's prison, where treatment for these young women’s dependencies is non-existent and sexual abuse is common. Similar themes have been found in Kyrgyzstan where a partner organization of Youth RISE interviewed 30 young women who use drugs. These women reported widespread sexual abuse by law enforcement officials and a lack of access to appropriate health services.

Punitive policies are often justified as necessary for the protection of young people. However, the logic that these policies deter young people from using drugs is clearly false and is not supported by academic evidence or by what we see on the ground. It is well documented that harsh penalties for drug offences compromise public health and increase the risk of drug related harms including HIV transmission by driving drug use underground into risky environments.

However, for the majority of young people who use illegal substances (many for only brief periods in their lives), the biggest hindrance to them fulfilling their potential is the impact of drug convictions, cautions and criminal records. In countries around the world, criminal charges for drug offences based on the possession of small amounts of substances result in young people being denied a proper education through, for example, school expulsion or denial of financial aid. The barriers they experience to education continue into their adult years where the same obstacles to gaining meaningful and long term employment exist.

We hope by raising the voices of young people, we can advance change in how drug issues are addressed, especially among the younger generation who will be integral to future policy formulation. Young people remain a population at risk, and they need to be given the opportunity to fulfill their potential. Humanism, pragmatism and the protection of the health and development of our youth must guide drug policy formulation. This requires support, not punishment.

This campaign is calling for:

• National governments to remove criminal sanctions for possessing drugs for personal use. Drugs must be prioritized as a public health issue rather than a law enforcement one, prioritizing the health, human rights and life chances of young people who use drugs.
• International institutions to support countries to move towards decriminalization and assist them in adopting public health based approaches for addressing young people who use drugs.
• Civil society organizations and NGO’s who support human rights and youth development to support the call for the decriminalization of young people who use drugs.
• Young people to be active in making their voices heard in this campaign and participate in drug policy reform.