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Banding Together to Challenge Schering-Plough's Monopoly on Hepatitis C Treatment

Spring 1999

The PWA Health Group has been importing ribavirin since the late 1980's, when its potential anti-viral activity against HIV was first being looked into. Ribavirin's promise as an anti-HIV agent didn't pan out; however, over the last few years, studies have shown the drug to be useful against hepatitis C when used in combination with alpha-interferon. Until last June, ribavirin remained unapproved in the United States, and more people with hepatitis C looked to the PWA Health Group to help them access the drug. In many ways, the current state of hepatitis C treatment is similar to what was going on with HIV treatment in the early 90's. Understanding how the virus works is confusing, questions of when or whether to start treatment are completely unclear, treatment options are very limited, how to interpret the relative success or failure of treatment is difficult, and one pharmaceutical company, Schering-Plough, is trying to "own" the disease in much the way that Burroughs-Wellcome attempted to "own" and profiteer off of HIV in the late 80's.

Now that ribavirin has been approved, although in an obscene package, the PWA Health Group continues to import ribavirin for people who want to create a hepatitis C treatment combination other than the one being forced on them by Schering-Plough. This continues the Health Group's tradition of carrying medications at lower prices than the pharmaceutical companies charge. We are also working with smart, imaginative and dedicated individuals to spearhead a national campaign to force Schering-Plough to respond in an ethical manner to the needs of people with hepatitis C. This campaign has included: working with the media; bringing together a coalition of organizations and individuals to work on the issue, including seasoned AIDS activists, people with HIV and hepatitis C co-infection, and people with hepatitis C who are new to advocacy work; meeting with representatives from Schering-Plough; calling for congressional hearings; and, if necessary, direct action.

The following consensus statement, endorsed by hepatitis C, HIV, and other health care organizations and individuals throughout the country, was sent to Schering-Plough and representatives at the FDA last month. If you or your organization would like to endorse the statement, please contact us at the Health Group. As this issue of Notes from the Underground goes to print, Schering-Plough is arranging a meeting for community representatives in April. This meeting must address the issues raised in the consensus statement in a substantive manner rather than provide the company a forum for a dog and pony show. We'll see.



Consensus Statement to Schering-Plough Pharmaceuticals from the Health Care Community Regarding Rebetron Development and Marketing

February 19, 1999

Raul E. Cesan
President and Chief Executive Officer
Schering-Plough Corporation

Dear Mr. Cesan:

Last year's FDA approval of ribavirin (Rebetol) as an anti-viral agent to be used in combination with alphainterferon is an indisputable advance in the treatment of Hepatitis C (HCV). Unfortunately, with that approval came a precedent-setting packaging practice which has created impediments to patient/doctor treatment choice and access the likes of which we have never seen. Schering-Plough's bundling and pricing decisions negatively affect every individual considering HCV treatment.

The undersigned coalition of organizations and individuals affected by Hepatitis C and, therefore, Schering-Plough's unethical practices demands the following:

  1. Ribavirin must be unbundled from Intron-A;

  2. The price of ribavirin must immediately be lowered in line with other anti-virals in the same nucleoside analogue class;

  3. HCV viral load results must be unblinded for participants in Schering-Plough clinical trials; and

  4. Schering must create access to Rebetron for those who cannot afford it and, until it is unbundled, create access to ribavirin for those who wish to use it in combination with another interferon.


UNBUNDLING OF REBETRON:

Ribavirin must be unbundled from Intron-A and made available as a separate anti-viral agent to be used in combination with other interferon formulations. It is to be clearly labeled so that the drug is not used as a single agent for HCV, but only in combination with another HCV treatment. In addition, clinical trials comparing the efficacy of Rebetron with combinations of ribavirin and other interferon formulations must be developed immediately through inter-company cooperation and access of ribavirin to private researchers.

Never in the history of drug development, approval or marketing has bundling like this been forced on any patient population. For example, Glaxo Wellcome manufacturers Combivir, which combines two of that cornpany's anti-HIV drugs, AZT and 3TC, in one pill. However, each of these drugs are also available individually, allowing people with HIV to pick and choose the most useful combination treatment for them. If Glaxo did what Schering has done, treatment options for people with HIV would be severely -- and dangerously -- limited. The bundling of ribavirin with Intron-A prevents doctors from the legal and common practice of prescribing off-label.

We know that the FDA is prepared to work with Schering on the unbundling process. People with Hepatitis C must be able to choose from the available interferons in order to have the best shot at ribavirin/interferon combination treatment. This is a matter of individual patient choice!


PRICING:

Ribavirin is to be cut in price by 75% from the current estimated price of $1,020/month (1,200 mg/day dosing)to $255/month, near its 1995 price and in line with current drugs in its class.

Ribavirin is an easy-to-manufacture nucleoside analog, yet its price is exceptionally high. It costs 346% more than Ziagen (abacavir), the most expensive anti-HIV nucleoside analog. Ribavirin is available as a single agent in Mexico and Western Europe, where Schering-Plough does not yet control the supply, and the price there is at least 265% lower than the putative U.S. price (calculated as the price of Rebetron minus that of Intron-A). Schering would have ample opportunity to make substantial profits with a lower-priced, unbundled ribavirin product since it is in high demand for use with other companies' interferons.


UNBLINDING OF VIRAL LOAD RESULTS IN CLINICAL TRIALS:

Schering-Plough must immediately unblind the results of clinical trial participants' HCV viral load tests. Rather than advising doctors to explain the reasons for blinding to their patients, Schering-Plough should initiate and finance an education campaign, implemented by the primary care physicians treating people with Hepatitis C, which will endeavor to explain the importance of viral load test results in assessing the full clinical picture of the individual's response to his/her treatment regimen. With such education, people enrolled in the clinical trials can make thoughtful, well-informed choices about whether or not to continue in the trial if their viral loads are increasing.

Schering-Plough must learn to treat trial participants as fully intelligent individuals capable of making informed decisions based on complete, clear and accurate communication between the investigators and the participants. Studying the history of HIV clinical trial design and the ethics involved in the creation of those trials would be of enormous value. There are members of the HIV and co-infected community who would be invaluable in these discussions.


THE CREATION OF ETHICAL PATIENT ASSISTANCE PROGRAMS:

Schering-Plough must develop two truly comprehensive, ethical drug assistance programs:

  1. a true, meaningful expanded access/compassionate use program to help individuals gain access to ribavirin alone in order to create viable personal treatment regimens with other available interferons, and

  2. a more conventional program to provide individuals access to Rebetron free-of-charge when they have no means to pay.

Until the products are unbundled, the expanded access/compassionate use program must allow individuals, through their doctors, to obtain ribavirin alone and free of charge for use with other interferons or different doses of Intron-A -- without having to jump through hoops and undergo substandard therapy first.

Guidelines for both patient assistance programs must be clearly written, publicly available, and must not be used to recruit patients into clinical trials. Schering must keep a record of all individuals who apply to the program, protecting anonymity by the use of unique identifier numbers, and provide a monthly report, publicly available for review, on the use of the programs.

Schering-Plough Pharmaceuticals is clearly invested in the development and marketing of Hepatitis C treatments. Schering representatives have indicated that the company understands the importance of developing a cooperative working relationship with the HCV community and its allies, including the HIV community and other individuals and organizations concerned with equitable access to health care and the ethical development of useful treatments. Since the issues discussed in this statement were first raised last summer, there has been little indication from Schering-Plough that the company takes patient concerns seriously. Rather, there has been obfuscation and the occasional bone. The major concerns remain unaddressed. Continuing such a strategy will only exacerbate the division between Schering-Plough and the broad community, satisfying neither party. The leadership to accomplish these goals clearly exists within the community. We look for similar leadership from Schering-Plough-leadership that leads to positive action.

Therefore, in the interest of public health, we the undersigned demand that Schering-Plough respond immediately to the concerns set forth in this statement.

We look forward to being contacted by you within the next two weeks to make arrangements to discuss these issues in a substantive manner. Please contact James Learned at the PWA Health Group, Brian Klein at HAAC, or Ben Cheng at Project Inform. People with HCV have waited long enough.

Signed:

ORGANIZATIONS:

ACT UP/Golden Gate
ACT UP/New York
ACT UP/Philadelphia
AIDS Action Baltimore
AIDS Action Council
AIDS Survival Project (GA)
AIDS Treatment Data Network
Being Alive; Boulder County AIDS Project
Central Pennsylvania Hepatitis Support Network
Critical Path AIDS Project
Direct AIDS Alternative Information Resources (DAAIR)
FAIR/Foundation for AIDS & Immune Research
Gay Men's Health Crisis (GMHC)
Harm Reduction Coalition
Hepatitis C Action and Advocacy Coalition/HAAC
Hepatitis C Action and Advocacy Coalition/HAAC - New Jersey
Hepatitis C Action and Advocacy Coalition/HAAC - New York
Hepatitis C Action and Advocacy Coalition/HAAC - Panther Valley Chapter
Hepatitis C Support Project
HIV Community Coalition (DC)
Houston Area Community Services, Inc.
Howard Brown Health Center (IL)
Lambda Legal Defense & Education Fund The Lambda Letters Project
Lower East Side Harm Reduction Center
Mothers' Voices
National AIDS Treatment Advocacy Project (NATAP) National Association of People With AIDS (NAPWA) National Hepatitis C Coalition, Inc.
National Minority AIDS Council (NMAC)
National Women & HIV/AIDS Project
New Jersey Hepatitis C Coalition
New Jersey Hepatitis C Organization
New Orleans Center for Living
People of Color AIDS Coalition
People With AIDS Coalition/New York (PWAC-NY)
Positive Health Project
Project Inform
PWA Health Group
PWA/HIV Coalition of Baltimore
Santa Cruz AIDS Project
Santa Cruz Needle Exchange
St. Joseph Support Group (MO)
Search for a Cure
Title 11 Conununity AIDS National Network Treatment Action Group (TAG)
United States Hepatitis Alliance (USHA)
University of California at SF AIDS Health Project Walden House, Inc. (San Francisco)
WAM Foundation (TX)
Women on a Mission/WOAM (MO)

INDIVIDUALS (Organizational affiliations are for identification purposes only):

Barbara S. Abbott; Eric Abrams; Cyndi Alleen; Mitchell & Valerie Anszis; Steve Ashenbrenner, instructor; Jeffrey M. Birnbaum, MD, MPH, Adolescent HIV Program/SUNY Health Sciences Center at Brooklyn; Paulette Blanco, educator; Danny F. Bogner; Diane Bonder; Simon Bovinett; Alianna S. Bowers, CAN; Richard Branam, instructor; Marilyn I. Brunger; Twillow Campbell, placement; Bill A. Carson; George Carter; Joseph Michael Clark, RN, CCM; Brian Coppedge; Steven V. Croasmun; Holly & John Cross; Renee Daurio; Julie Davids; J. Todd Diener, People of Color AIDS Coalition; David A. Donovan, PhD, UCSF AIDS Health Project; Kenn Doyle; Cynthia Dunning; Amy East; Bill Fairchild; Bill Fairchild, Sr.; Nancy Fairchild; Norma Fairchild; Tom Faulk; Andrew Van Felix; Rosario Fernandes; Alan Franciscus, Director, Hepatitis C Support Project; Richard N. Freeman; Debbie S. Garcia; Robert H. Garcia; Valeria Gaufillier; Jeff Getty; Dave Gilden, Editor, Treatment Issues, GMHC; Eric Gregory; Linda Grinberg; Howard Grossman, MD; Rose Marie Hamilton-Flies; Fred Hanson; Johnny Harriss, Jr., Houston Area Community Services, Inc.; JC Hernandez, HIV Community Coalition; Julie Hicks, stylist; Bob Hicks, travel agent; Henry Hill, assistant manager; Lori Hill, audiologist; Kenneth E. Hitch; William H. Hoffman, RpH; Carlton Hogan; Thomas Holmes; Beau Hooker; Doug Hooker, electrician; Laurie Hooker, social worker; Tim Hom; Jere L. Hough; Lenore Howe; Fred W. Ihler; Kathleen Ivanochick; Stephen Ivanochick; George Jagiello; Leila Jeffries; Carolie Jenner; Michael A. Jones, WAM Foundation; Susan J. Jones; Michele Kiger; Eleanore R. King; George G. Kinyon; David Kiviabo, Executive Director, New Orleans Center for Living; Brian Klein, HAAC/SF; Drew Kramer, Executive Director, Lower East Side Harm Reduction Center; Staci L. Krause; Lark Lands, PhD, POZ Magazine, Science Editor; James Learned, PWA Health Group; Jed Levine; Suzanne Lloyd; Maria Mann; Robert Marek; Laurence D. M. Marshall; Sheila Mathews; Joseph K. McCrink; Pamela McDaniel; Toni Meyers, health care worker; Alice Miele; Sharon K. Moen; Jacklyn Montero; Susan Moscou, FNP; Allan Muchmore; Steven Nesseiroth, Director, AIDS in Prison Project, The Osborne Association; Mark Niedzolkowski; Jim & Terri Newman; Caryl Jean Nixon, secretary; Joan Nordberg; Larry D. Norton; Lisa O'Connor, HIV Services Coordinator, Walden House, Co-Chair, PWA Caucus, SF HIV Health Services Planning Council; Randa Gail Ogden; Wendy Peikes; David Perribone; Billy Pick, person living with HIV/HCV; Jennifer L. Pitino; Nicky Proudfoot, landlord; Lynne L. Roach; Patti Roark; Vicki Rudisill, teacher; Louise F. Sampson, HAAC/NJ; Raoul B. Salem; Josephine Scherer; David Scondras, Search for a Cure; Laura F. Scott, New Orleans Center for Living; Lynn Shawn, B.S., C.N.E.; Marion N. Shillingburg; Dorothy Siegle; Mari C. Simon, teacher; Sasha Siocomber, Director of Outreach, FROSTD; Marianne SquireMaszer; Teryl Stewart; Steven Strasma; Fred Swanson, M. A., Coordinator of Community Education and Health Outreach, Howard Brown Health Center; Sondra R. Tabor, RN; Lillian Thiemann; Karin Timour, M.A., M.Ed.; Grant E. Tolman; Jean Travis; Jim Travis; Janice K. Turner; Carolyn A. Virtue; Enid Vazquez; Victoria Vitolo, NJ Hepatitis C Coalition; Julianna Walters; Shoshana Wechsler; Margie Wells; Juliet Widoff; Linda Wilkerson; Barbara Wilson, teacher; LaNita Wilson; Tekakwitha Wilson, Vice-President, New Orleans Center for Living; Betsy Baldwin Wofford, farmer; Ernie Wofford, farmer; Roy Wolf, instructor; Christopher Brian Woods, New Orleans Center for Living; Jennie Worthington; Fay Wouk; Nina Wouk; Robert H. Zimmerman

cc: Richard Zahn, President, Schering Oncology/Biotech
Heidi M. Jolson, MD, MPH, Director, Division of Antiviral Drug Products, Food & Drug Administration
Richard Klein, Office of Special Health Issues, Food & Drug Administration
Robert M. Tenery, Jr., Council on Ethical and Judicial Affairs, American Medical Association
Kathleen Hurtado, Vice-President, Marketing & Sales, Schering-Plough Pharmaceuticals
Stephen Taglienti, Senior Product Manager, Schering Laboratories


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