Margaret Dudley, a 61-year old resident of San Antonio, Texas, mother of three and grandmother of six, was diagnosed with the Hepatitis C virus (HCV) in September, 2011. A cosmetic tattoo delivered the life-threatening virus.
Margaret immediately began researching everything she could about the disease, and most important, seeking a cure. She learned there was a groundbreaking cure. In April 2012, Bristol-Myers Squibb (BMS) announced it achieved a 100 percent cure rate for HCV. In phase two trials, Bristol-Myers Squibb, using its drug daclatasvir in combination with sofosbuvir from Gilead Sciences, achieved a major milestone: 100 percent cure rate for HCV type 1, with similar results with the same drugs for HCV type 2 and HCV type 3. The two companies each own a drug that in combination has cured hepatitis patients in 12 weeks. The all-oral combination is a huge advance, due not only to the remarkable results, but because they had mild side effects (mild to moderate fatigue, headache, nausea) that were well-tolerated, unlike the traditional two-drug chemo-style treatment, interferon and ribavirin, both of which have severe and debilitating side effects and only cure about 40 percent of the time.
About 3.2 million people in the U.S. have Hepatitis C, a blood-borne disease that attacks the liver. It’s the number one reason for liver transplants in the U.S. and kills more people than AIDS and is linked to over 12,000 U.S. deaths a year. HCV also can be a silent killer, destroying a person’s liver over years without symptoms. The Centers for Disease Control recently issued a warning and recommends that everyone between the ages of 45 and 65 be tested. Millions more could have the virus and not know it.
But Gilead isn’t interested in pursuing the combination, although Bristol-Myers Squibb is. Dr. Douglas J. Manion, a senior vice president for Bristol-Myers, said his company was “keen” on working with Gilead but “thus far, they have been unwilling to engage in that collaboration.” Each has unsuccessfully tried to replicate the other’s drug.
Seeing that her life and millions of others are hanging in the balance, Margaret launched a petition at Change.org urging Gilead to make the life-saving medication available for the millions of Hepatitis C sufferers and for herself as well. “Although it feels much like a David vs. Goliath battle trying to get Gilead to reconsider its position, I have now become an advocate for this cause and have formed a grassroots effort, HCV Coalition for The Cure. I want to bring the nation’s attention to this dire situation.”
She has enlisted the support of many including the Aids Healthcare Foundation, but Gilead has not relented. “The unfettered greed that drives the lack of cooperation between pharmaceutical giants Gilead and Bristol-Myers Squibb comes at the unacceptably high price of the health and well being of Hepatitis C patients,” said AHF President Michael Weinstein. “The withholding of effective treatment for patients suffering from this illness to instead boost shareholder returns has gone on for too long… this travesty must end.”
Many experts in the medical field agree. “We had never, ever imagined—even in our wildest dreams—we could treat hepatitis C so quickly, effectively and without serious side effects,” said Paul Thuluvath, a doctor at Mercy Medical Center in Baltimore who had six patients test the new treatment. “I think the pharmaceutical companies have a moral responsibility to work together and bring it to market instead of [following] their own vested interests.”
Today, Margaret is working with Craig Quirolo, one of the patients cured during phase two trials using the winning combination. Craig believes it is time to launch a national campaign and the two are collaborating to launch a petition drive on the White House website. “President Obama could offer incentives to the drug companies which would encourage them to end this standoff and move forward to save lives. It’s time to think and act out of the box. If the two companies do not collaborate, a new successful cocktail of drugs that works could take years, time many patients don’t have,” said Quirolo. But they’ll need 100,000 signatures within a month’s time for it to reach President Obama’s desk. The launch date of the petition is Feb. 19, 2013.