Index of CPT pages relating to pharmaceutical research and development.

February 2, 2005. Representative Bernie Sanders. Letter to the Members of the WHO Commission on Intellectual Property Rights, Innovation, and Public Health. Summary of the Medical Innovation Prize Fund - H.R. 417.

HR 5155 - The Free Market Drug Act

• The text of the bill will be posted here when made available by the GPO
• September 28, 2004. Press release from Rep. Kucinich's office. Kucinich Intorduces Legislation To Lower The Price Of Prescription Drugs. Also, see the undated Q and A page the office has put together on this bill.
• September 28, 2004. Susan Jaffe for the Cleveland Plain Dealer. Kucinich wants government to oversee drug research.

Reasonable Pricing Clause for Government Funded Drugs

• October 12, 2001. Press release from Bernie Sanders. Sanders Passes Prescription Drug “Reasonable Pricing” Amendment.
• October , 2001. BNA Daily Report for Executives. House-Passed Labor-HHS Spending Bill Includes Sanders's Drug Pricing Amendment.
• June 14, 2000, Reasonable Pricing For Prescription Drugs House Amendment 791 (A033), sponsored by Congressman Bernard Sanders passes with a vote of 313 to 109.
• Frequently Asked Questions about Reasonable Pricing of Government Funded Medical Inventions.
• Copies of Bills and amendments that would require reasonable pricing of government funded medical inventions:
  • From the 106th Congress, H.R. 626, The Health care Research and Development and Taxpeyer Protection Act.
  • From the 105th Congress, H.R. 3758, the Health Care Research and Development and Taxpayer Protection Act.
  • From the 104th Congress, HR 4270 is a legislative proposal by Representative Bernie Sanders (I-VT), that addresses many issues in drug pricing.

• CPT page on HIV/AIDS drugs.
• CPT pages on particular drugs:
  • Paclitaxel (Taxol)
  • Stavudine (d4T)
  • Glucophage (Metformin Hydrochloride)
  • Gleevec/Glivec/STI-571
• CPT page on the Bayh-Dole Act.
• NCI Role in the Development of 50 Anticancer Drugs
• NCI Role in the Development of 37 Anticancer Drugs

• June 22, 2001. Letter to Peter Dolan, President and CEO of Bristol Myers Squibb, signed by Ralph Nader and James Love. The letter lists various subsidies, including government R&D, received by BMS.
• June 9, 2001. Response from DHHS Secretary Thompson to Letter from Ralph Nader, James Love and Rob Weismann.
• March 28, 2001. Letter to DHHS Secretary Tommy Thompson from Ralph Nader, James Love, and Robert Weissman, requesting that DHHS provide the World Health Organization, UNICEF and other public health organizations access to US government funded medical inventions.
• October 19, 1999 letter from NIH Director, Dr. Harold Varmus to Ralph Nader, James Love and Robert Weissman responding to their request calling on the NIH to provide the World Health Organization, WHO, access to US government funded medical inventions.
• September 3, 1999, Ralph Nader, James Love, Robert Weissman letter to Dr. Harold Varmus, Director of NIH, asking for NIH to give the World Health Organization, WHO, access to US government funded medical inventions.
• May 13, 1999 letter to Congress regarding HR 209 and S. 804, bills that would reduce competition and increase secrecy and underming public accountability, for government funded inventions.
• James Love's May 15, 1998 note to e-drug and pharm-policy, regarding government funded drugs.
• January 13, 1997, James Love, the Marketletter, "Call for More Reliable Costs Data on Clinical Trials." The Article finds industry estimates of pharmaceutical drug development costs at odds with data from U.S. Tax returns on Orphan Drug clinicial trials, and NIH funded clincial trials. Also interteresting is PhRMA's response to the article. In this article, the most important data are the reports of US industy spending on clinical trials for orphan drugs, based upon US tax returns. The reports the pharmacuetical industry claimed $107 million in tax credits from 1983 to 1993. This represented one half of company expenditures on clinical trials for all orphan drugs tested during this period, when 93 orphan drugs were approved for marketing. During this period, all HIV/AIDS drugs were classified as orphan drugs. Company expenditures of clinical trials were $2.3 million per approved drug, before the credit, and $1.15 million, after the credit. These data are startling low, and suggest both that industry estimates of development costs are high, and that the US government's role in the development of these drugs is high. Subsequent to the publishing of the paper, questions were raised about the interpretation of the data on the NIH funded clinical trials, particularly the issue of the number of trials that is typical at each Phase of clinical trials. New estimates of government funded clinical trials should be available early 2000. Also, the Marketletter article incorrectly reports that PhRMA had published the 1991 DiMasi et all Tufts study of drug development under its own cover.
• October 8, 1994, Prepared Statement of James Love On Prescription Benefits and the Clinton Health Care Plan, before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce of the U.S. House of Representatives.
• James Love, September 8, 1994 Pricing of Drugs Developed with Public Funds: Comments Presented to the Second NIH CRADA Forum.
• July 11, 1994 Comments by James Love on the Need for Better Federal Government Oversight of Taxpayer Supported Research and Development, presented before the Subcommittee on Regulation, Business Opportunities and Technology of the Committee on Small Business, U.S. House of Representatives
• February 24, 1993, Ralph Nader and James Love, Federally Funded Pharmaceutical Inventions, Testimony before the Special Committee on the Aging, United States Senate. The testimony including the following data:
  • In 1991, 7 of 10 FDA priority drugs (Class A, AA or E New Chemical Entities) were developed with public support.
  • Prices for drugs developed with public support were far more expensive than drugs developed without government funding.
  • Of the 37 new cancer drugs discovered and approved for marketing since the National Cancer Institute's new drug screening program began in 1955, 34 were developed with US government support.

• NIH - National Center for Research Resources.
• January 30, 2004. Alan Holmer, President of PhRMA. Letter to the editor of Time Magazine.
• June 6, 2002. Rep. Sherrod Brown Openning Statement for Commerce Health Subcommittee Hearing on NIH Funding Priorities.
• July 2001. NIH report to Congress. A Plan to Ensure Taxpayers' Interests are Protected. This report reaches the conclusion that the federal government should not seek royalties on its research.
• July 7, 2001. Pharm Policy archives. A few USG HIV and malaria exclusive patent license notices.
• July 6, 2001. Announcement ofthe Department of the Defense. Department of the Navy Notice of Intent to Grant Exclusive Patent License.
• May 24, 2001. Statement by Richard Klausner, Director of the National Cancer Institute. Fiscal Year 2002 President's Budget Request for the National Cancer Institute.
• October 8, 2000, bioinfo.com, Department of Defense (DOD) grants exclusive license on a patent for the Encephalitis vaccine
• October 8, 2000, bioinfo.com, Hepatitis C Virus Patent Dispute Interesting (but somewhat dated) account of patent dispute involving a former CDC official and Chiron Corp from 1995.
• May 17, 2000, Joint Economic Committee. The Benefits of Medical Research and the Role of NIH.
  

  A study of the 21 drugs introduced between 1965 and 1992 that were considered by experts to have had the highest therapeutic impact on society found that public funding of research was instrumental in the development of 15 of the 21 drugs (71 percent). Three-captopril (Capoten), fluoxetine (Prozac), and acyclovir (Zovirax)-had more than $1 billion in sales in 1994 and 1995. In addition to these drugs, other members of the group of 21 drugs, including AZT, acyclovir, fluconazole (Diflucan), foscarnet (Foscavir), and ketoconazole (Nizoral), had NIH funding and research to help in clinical trials.

• April 11, 2000 University of Rochester awarded a pioneering patent covering the use of all cox-2 inhibitors.
• Federal Obligations for Health R&D, Fiscal Years 1985-1999.
• Federal Health R&D, percentage allocations by performer. Figures from 1985-1997, estimated figures for 1998 and 1999.
• June 4, 1998. Report of the National Institutes of Health (NIH) Working Group on Research Tools This report issues five recommendations on NIH technology transfer policy:
  1. NIH should promote free dissemination of research tools without legal agreements whenever possible, especially when the prospect of commercial gain is remote.
  2. NIH should promote use of the Uniform Biological Materials Transfer Agreement (UBMTA) and the development of other standard agreements to reduce the need for case-by-case review and negotiations.
  3. NIH should develop and disseminate guidelines1 for recipients of NIH funds as to reasonable terms in licenses and MTAs, addressing both importing of research tools from other institutions and exporting of research tools created with NIH funds.
  4. NIH should review its policies with regard to dissemination of research tools generated under its intramural and extramural funding, and revise and strengthen those policies consistent with the recommendations in this report.
  5. NIH should promote the establishment of a research tools forum for the biomedical research and development community
• Gregory K. Folkers and Anthony S. Fauci, The Role of US Government Agencies in Vaccine Research and Development, May 1998, Nature Medicine Vaccine Supplement.
• March, 1997, CHI Research Newsletter, Vol. V, No.1, Industry Technology has Strong Roots in Public Science

  CHI traced more than 45,000 references from U.S. patents to the underlying research papers, and tabulated both the institutional and financial origins of the cited science. We found that more than 70 percent of the scientific papers cited on the front pages of U.S. Industry patents came from public science -- science performed at universities, government labs, and other public agencies.

• 1997 NIH Office of Rare Diseases. Annual Report on the Rare Diseases and Conditions Research Activities of the National Institutes of Health.
• The July 11, 1996 Debate and Vote on the Sanders Amendment to the 1997 HHS Appropriations Bill which would have restored the Reasonable Pricing Clause for certain drugs whose development was supported by the U.S. government.
• One the issue of drugs for Malaria, this quote is from Stanley C. Oaks, Jr., Violaine S. Mitchell, Greg Pearson, and Charles C. J. Carpenter, Editors, Malaria: Obstacles and Opportunities A Report off the Committee for the Study of Malaria Prevention and Control: Status of Review and Alternative Strategies, Division of International Health, Institute of Medicine, National Academy Press, Washington, DC 1991, page 157.

  Unfortunately, antimalerial drug discovery and development is of little interest to pharmaceutical firms. Because the vast majority of malaria cases occur in poor individuals living is less developed countries with nonconvertible currencies, even if a new and highly effective antimalarial compound were developed, a drug company likely would suffer a poor return on the money it invested in research and development.

  Where are most maleria drugs developed? At Walter Reed Army Institute of Research.
• Estimates of National Support for Health Care R&D by Source of Funds, 1986 to 1995. According this report, sources of US health care R&D are 52 percent industry, 38 percent federal government, and 10 percent state and local government and private foundations.
• 1992, The Office of Technology Assessment, Federal and Private Roles in the Development and Provision of Alglucerase Therapy for Gaucher Disease, OTA-BP-H-104, NTIS order #PB93-101723.

• June 21, 2005. Leila Abboud for the Wall Street Journal. Government Offers Funds For New Drug Research.
• February 28, 2003. Kaiser News Network. White House Mandates NIH AIDS Research Funds Be Funneled to New Anthrax Vaccine Development.
• February 24, 2003. Eugene Russo for the Scientist. The NIH: A Budget Appraisal.
• June 14, 2002. Editorial in The Age (Australian paper). An offer too bad to accept.
• June 6, 2002. Emily Yoffe for Slate. Teaching Old Drugs New Tricks.
• Janury 24, 2002. Chris Adams for the Wall Street Journal. U.S. AIDS Researcher Criticizes Planned Trials of HIV Vaccine.
• January 23, 2002. Reuters. Rivalry in US Hampers AIDS Vaccine Search-Scientist.
• May 14, 2000, Peter G. Gosselin, in the Los Angeles Times, Law Catalyzes Research but May Face Dilution Patents: Bayh-Dole Act has hastened drug and Internet breakthroughs.
• April 23, 2000, Jeff Gerth and Sheryl Gay Stolberg in the New York Times, MEDICINE MERCHANTS- Drug Companies Profit From Research Supported by Taxpayers. This case study of Xalatan, an eyedrop for glaucoma marketed by Pharmacia. Here are some quotes:

  In a 1997 study commissioned by the National Science Foundation, C.H.I. looked at the most significant scientific research papers cited in medicine patents. It found that half the cited studies were paid for with United States public funds, primarily from government and academia; only 17 percent were paid for by industry. (The rest came from public and private foreign sources.

  And in a study with the National Eye Institute, published in 1996, C.H.I. found that 41 percent of patented eye-care technology was linked to research financed by the health institutes, including Dr. Bito's studies, which have been cited in 15 patents, including Xalatan's.

  "I think that is very typical," Dr. Narin said of Dr. Bito's work. "If you find any good advanced biomedical patent, and you look at its science references, most of them are going to be public," meaning from publicly financed research.

  . . .last year, Pharmacia spent $650 million to buy Sugen, a biotech concern in San Francisco that is collaborating with the National Cancer Institute on clinical trials of its two leading drugs. The company's co-founder, Dr. Joseph Schlessinger, is a New York University scientist whose initial financing included a nine-year grant from the cancer institute, N.I.H. records show.

  So the pharmaceutical companies have become more efficient, in part because university researchers are more efficient. As Dr. Levy put it, the companies are "not having to dig as many dry holes."

  The Phase 3 study of Xalatan was relatively small, just 829 people. The company will not say what it spent on that study, or any other. But Dr. Stjernschantz, the project manager, said the total costs for all trials was significantly less than $30 million, an estimate that, a Columbia researcher said, Pharmacia provided to the university before the testing had begun.

  Today, Xalatan is approved for sale around the world, from the United States to Japan, Australia and all across Europe. The key ingredient is still being manufactured at Chinoin in Budapest, although the Hungarian company has since become a subsidiary of Sanofi, the French pharmaceutical giant.

  The Chinoin-Pharmacia partnership has been a profitable one. Chinoin is making a 50 percent return on its prostaglandin investment, company officials said. And Pharmacia pays Chinoin slightly more than $5 million a year for the manufacturing of latanaprost, said Tibor Szabo, who directs the prostaglandin business unit at Chinoin.

  That amounts to roughly one one-hundredth of Xalatan's $507 million in annual sales last year. Or, to put it another way, the cost of making the key ingredient is just 1 percent of the revenue Xalatan generates.

• April 5, 1998, Alice Dembner and the Boston Globe Spotlight Team, Public handouts enrich drug makers, scientists, First of three parts. From this link you can find the other stories in this series. Unfortunately, the Boston Globe did not publish the entire series on the web. A print only section from April 5, 1998, titled "Private Profits from Public Funds," has this quote:

  "The Globe looked at 50 top-selling drugs approved by the Food and Drug Administration over the past five years: 35 new drugs, which are bestsellers among those the FDA deemed most important or most unique, and 15 "orphan" drugs targeting rare diseases. Thirty-three of the 35 new drugs and 12 of the 15 orphans received money from the National Institutes of Health or the FDA to help in discovery, development, or testing."