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Status Brief

Developmental Milestones/Developments to Date:

Current Assessment/State of the Field:



Web Resources

Access to Medicine Foundation

  1. “The Access to Medicine Foundation is an international not for profit organization dedicated to improving access to medicines to societies in need. Based in Haarlem, The Netherlands, the foundation publishes the Access to Medicine Index, the first index of its kind to rank pharmaceutical companies with respect to their efforts to enhance global access to medicines.”
  2. “The goal of the Access of Medicine Index is to supply pharmaceutical companies, investors, governments, academics, nongovernmental organizations and the general public with independent, impartial and reliable information on individual pharmaceutical companies’ efforts to improve global access to medicines.”

Pharma, Developing Countries


Setlak, Paul, “Bioterrorism preparedness and response: Emerging role for health-system pharmacists”, American Journal of Health-System Pharmacy , 2004.

  1. “Furthermore, as pharmacists are becoming more integral in disaster relief and response, especially in the area of bioterrorism, they must be able to effectively and rapidly access the most current information about the biological agents they may encounter and the respective treatments.” (Pg. 1)
  2. “Once a pharmacist is accepted as a member of an NPRT, he or she must complete numerous Web-based training programs on emergency response, pharmaceutical caches, command operations, occupational health, and a host of other topics relating to bioterrorism and emergency response operations” (Pg. 3)
  3. “If called to serve in an emergency operation, each team will be deployed for approximately two weeks, during which time members will become temporary federal employees.” (Pg. 3)
  4. “The passage of USERRA by Congress in 1994 ensured that individuals serving in the uniformed services, including PHS and others designated by the president during war or an emergency, can return to their civilian job with the same seniority, pay, and status that they had before their service.” (Pg. 3)
  5. “The drill exposed pharmacists to the environment encountered during a pharmaceutical distribution campaign, taught them procedures for distributing mass quantities of medications, and allowed students to witness how pharmacists handle stressful situations.” (Pg. 4)
  6. “The SNS is an important deployable initial pharmaceutical stockpile for health care professionals at the state and local levels during the early stages of a bioterrorist attack.11 The Homeland Security Act of 2002 assigned responsibility for the deployment of the SNS to DHS.” (Pg. 4)
  7. “Avoiding unnecessary duplicated medications in stockpiles, repeated diagnostic steps, and similar patient paperwork can result in faster response and clinical decision-making and decrease patient fatalities.” (Pg. 7)
  8. “Treatment guidelines are available as downloadable charts for easy posting and presentation. In addition, links to federal and private sites that address bioterrorism are presented. All information is scrutinized by CDC, and great care is put into releasing correct and timely information that clinicians, especially health-system pharmacists, can use.” (Pg. 7)

Bioterrorism, Emergency Response, Pharma, CDC


Editors, “Systematic Review: Surveillance Systems for Early Detection of Bioterrorism-Related Diseases“. American College of Physicians. 2004.

  1. “the recent outbreaks of severe acute respiratory syndrome (SARS) and influenza strikingly demonstrate the continuing threat from illnesses resulting from bioterrorism and related infectious diseases. In particular, these outbreaks have highlighted that an essential component of preparations for illnesses and syndromes potentially related to bioterrorism includes the deployment of surveillance systems that can rapidly detect and monitor the course of an outbreak and thus minimize associated morbidity and mortality”(Pg 1.).
  2. “Little is known about the accuracy of surveillance systems for bioterrorism and related emerging infectious diseases, perhaps because of the diversity of potential data sources for bioterrorism surveillance data; methods for their analysis; and the uncertainty about the costs, benefits, and detection characteristics of each.”(Pg. 1)
  3. “Because most patients with bioterrorism-related diseases initially present with influenza-like illness, acute respiratory distress, gastrointestinal symptoms, febrile hemorrhagic syndromes, and febrile illnesses with either dermatologic or neurologic findings, we considered these conditions to be the bioterrorism-related syndromes.”(Pg. 2)
  4. “We identified 2 types of systems for surveillance of bioterrorism-related diseases or syndromes: those that monitor the incidence of bioterrorism-related syndromes and those that collect and transmit bioterrorism detection data from environmental or clinical samples to decision makers.”(Pg. 3)
  5. “The Interim Biological Agent Detector is used on U.S. naval ships to continuously monitor the air for a significant increase in particulate concentrations (32, 39–42). If a peak increase is detected, the instrument automatically collects an aerosol sample and alerts the ship’s damage control center so the crew can collect and screen the sample with a handheld antigen test.” (Pg. 5)
  6. “Our systematic review identified 115 existing surveillance systems, 29 of which were designed for surveillance of illnesses and syndromes associated with bioterrorism relevant pathogens. The evidence used to judge the usefulness of the reviewed systems is limited. Of the studies that evaluated systems for their intended purpose, few adhered to the CDC’s published criteria for high-quality evaluations of surveillance systems.”(Pg. 6)
  7. “Systems for bioterrorism surveillance require 3 key features: timeliness, high sensitivity and specificity, and routine analysis and presentation of the data that facilitate public health decision making.” (Pg. 6)
  8. “Systems with inadequate specificity may have frequent false alarms, which may result in costly actions by clinicians and public health officials”(Pg. 7)
  9. “Systems that collect pharmaceutical data, such as EPIFAR (198), are promising for bioterrorism surveillance. Pharmaceutical data, particularly over-the-counter medication sales data, can indicate an outbreak, although these data would probably not be specific for bioterrorism. In addition, most pharmaceutical sales are tracked electronically.” (Pg. 7)

Bioterrorism, Biosurveillance, Biodetection, Public Health, Pharma


Pollack, Andrew, “New Drug For H1N1 Flu Offers Hope,” NYT, B1, Nov. 6, 2009.

  1. “Peramivir might also be a life saver for its developer, BioCryst Pharmaceuticals, an unprofitable biotechnology company in Birmingham, Ala.”
  2. “On Thursday, the federal government ordered on an emergency basis, 10,000 treatment courses or peramivir for its national stockpile.”
  3. “Peramivir is given intravenously, making it usable by hospitalized patients who are too ill to take two approved flu drugs that work against the virus in similar ways.”
  4. “The F.D.A. granted authority for the drug to be used in emergencies.”
  5. “Before that, peramivir had been available only through a more cumbersome ‘compassionate use’ procedure. Of the 32 patients who received the drug that way, 29 are still alive.” *”Some of the push to make the drug more widely available is coming from investors in BioCryst, including Kleiner Perkins Caufield & Byers, the prominent Siliconvalley venture capital firm.”
  6. “Other investors — both supporters of BioCryst stock and those betting the price will fall — have commented at government meetings on flu preparations, often without revealing their financial interests.” *=
  7. “There had been 237 requests to use the drug since the emergency use authorization was granted nearly two weeks ago.”
  8. “It also says it has signed up partners to try to win sales in Brazil, Mexici, Isreal and China.”
  9. “Virtually all money to develop the drug comes from $180 million in grants from the Department of Health and Human Services. Yet the company gets to keep as profit anything it makes from selling the drug to the federal government or to other governments.”

Flu, Pharma


Pollack, Andrew, “Sanofi Taps Biotech Firm To Bolster Its Pipeline,” NYT, B3, Nov. 11, 2009.

  1. “Regeneron has developed genetically engineered mice that can produce human antibodies.”
  2. “It [Sanofi-Aventi] and other big companies are trying to move more into biotechnology, making drugs from living cells instead of from the chemicals they usually use.”
  3. “In some cases, the biotech drugs can do things that chemical drugs cannot. The biotech drugs are also not subject to the same sudden generic competition that can devastate sales of chemical drugs.”



Associated Press, “Pfizer drug studies fudged, report says: Studies indicated the drugs worked better than internal documents showed,” Last Checked Nov. 11, 2009.

  1. “Analysis of a dozen published studies testing possible new uses for a Pfizer Inc. epilepsy drug found that reporting of the results was often fudged, indicating the medicine worked better than internal company documents showed.”
  2. “Arthur Caplan, director of the University of Pennsylvania’s Center for Bioethics, called the report ‘one of the most ethically disturbing papers I’ve read in some time’ and ‘an indication that people have been playing fast and loose with studies,’ particularly industry ones.”

Pharma, Misconduct


McNeill, Donald, “Ally for the Poor in an Unlikely Corner,” NYT, February 9, 2010.

  1. “Last year, in a speech to Harvard medical students, Mr. Witty promised to keep the prices of all Glaxo drugs in poor countries to no more than 25 percent of what was charged in rich ones, and to donate one-fifth of all profits made in poor countries toward building their health systems.”
  2. “Last year, in a speech to Harvard medical students, Mr. Witty promised to keep the prices of all Glaxo drugs in poor countries to no more than 25 percent of what was charged in rich ones, and to donate one-fifth of all profits made in poor countries toward building their health systems.”
  3. “‘If they were seriously interested in patent pools.’ Mr. Berman said, echoing a criticism voiced by Oxfam as well, ‘they’d try out the Unitaid one.’ (Unitaid, a European agency using an airline ticket tax to buy drugs for poor countries, has offered to oversee a pool of patents on AIDS drugs so new combination pills can be made cheaply.)”

Pharma, Developing Countries


Godlee, Fiona, “Conflicts of interest and pandemic flu,” BMJ 2010; 340:c2947, June 3, 2010. Last checked March 14, 2011.

  1. “…countries like France and the United Kingdom who have stockpiled drugs and vaccines are now busy unpicking vaccine contracts, selling unused vaccine to other countries, and sitting on huge piles of unused oseltamivir. Meanwhile drug companies have banked vast profits—$7bn (£4.8bn; €5.7bn) to $10bn from vaccines alone according to investment bank JP Morgan.1 Given the scale of public cost and private profit, it would seem important to know that WHO’s key decisions were free from commercial influence.”
  2. “An investigation by the BMJ and the Bureau of Investigative Journalism, published this week (doi:10.1136/bmj.c2912), finds that this was far from the case.2 As reported by Deborah Cohen and Philip Carter, some of the experts advising WHO on the pandemic had declarable financial ties with drug companies that were producing antivirals and influenza vaccines. As an example, WHO’s guidance on the use of antivirals in a pandemic was authored by an influenza expert who at the same time was receiving payments from Roche, the manufacturer of oseltamivir (Tamiflu), for consultancy work and lecturing. Although most of the experts consulted by WHO made no secret of their industry ties in other settings, WHO itself has so far declined to explain to what extent it knew about these conflicts of interest or how it managed them.”
  3. “This lack of transparency is compounded by the existence of a secret “emergency committee,” which advised the director general Margaret Chan on when to declare the pandemic—a decision that triggered costly pre-established vaccine contracts around the world. Curiously, the names of the 16 committee members are known only to people within WHO.”
  4. “Cohen and Carter’s findings resonate with those of other investigations, most notably an inquiry by the Council of Europe, which reports this week and is extremely critical of WHO.1 It concludes that decision making around the influenza A/H1N1 crisis has been lacking in transparency.”
  5. “One of its chief protagonists is Paul Flynn, a UK member of parliament and a member of the council’s Parliamentary Assembly. He and others raised concerns last year about the lack of evidence to justify the scale of the international response to H1N1 (as also covered in the BMJ in December3), and the lack of transparency around the decision making process for declaring the pandemic.”
  6. “As Cohen and Carter report, WHO subsequently published in 2003 new rules on managing conflicts of interest. These recommended that people with a conflict of interest should not be involved in the part of the discussion or the piece of work affected by that interest or, in certain circumstances, that they should not participate in the relevant discussion or work at all.7 WHO seems not to have followed its own rules for the decision making around the pandemic.”
  7. “As Barbara Mintzes says in Cohen and Carter’s report, ‘No one should be on a committee developing guidelines if they have links to companies that either produce a product—vaccine or drug—or a medical device or test for a disease.’”

WHO, Flu, Pandemic, Misconduct, Pharma


Pharmaceutical Research and Manufacturers of America, “Medicines in Development for Infectious Diseases,” Report, Biopharmaceutical Research Continues Against Infectious Diseases with 395 Medicines and Vaccines in Testing,, September 10, 2010.

  1. “America’s biopharmaceutical research companies are developing 395 medicines and vaccines to combat the many threats posed by infectious diseases. Each of these medicines in development is either in clinical trials or under review by the Food and Drug Administration.”
  2. “Among the medicines now being tested are 88 antibiotics/antibacterials for treating bacterial infections such as pneumonia and tuberculosis; 96 antivirals for treating such viruses as hepatitis, herpes and influenza; and 145 vaccines to prevent or treat diseases such as staph infections and pneumococcal infections. Not included in this report are medicines in development for HIV infection.”
  3. “Two combined monoclonal antibodies that bind to, neutralize, and destroy toxins caused by Escherichia coli infections.”
  4. “A medicine for the most common and difficult-to-treat form of hepatitis C that inhibits the enzyme essential for viral replication.”
  5. “An anti-malarial drug that has shown activity against Plasmodium falciparum malaria that is resistant to current treatments.”
  6. “A potential new class of antibiotics to treat methicillin-resistant Staphylococcus aureus (MRSA).”
  7. “A novel treatment that works by blocking the ability of the smallpox virus to spread to other cells, thus preventing it from causing disease.”
  8. “‘Included are several developments for anthrax vaccines.’”

Anthrax, Prophylaxis, Vaccination, Drug Resistance, Pharma


Ebscohost. “Germ beats ‘last resort’ antibiotics“. USA TODAY, Sept. 17, 2010.

  1. “Bacteria that are able to survive every modern antibiotic are cropping up in many U.S. hospitals and are spreading outside the USA, public health officials say.”
  2. “The bugs, reported by hospitals in more than 20 states, typically strike the critically ill and are fatal in 30% to 60% of cases”
  3. “The bacteria are equipped with a gene that enables them to produce an enzyme that disables antibiotics.’’
  4. “Today, resistance has spread to more than 8% of these bacteria. No one knows precisely how many people have KPC infections because cases aren’t routinely reported to the CDC.”
  5. “One of the only drugs that combats these bugs is polymixin, which was all but abandoned years ago because it is so toxic to the kidneys, Fishman says. As a result, he says, prevention is crucial.”
  6. “”When MRSA started to develop 15 years ago, the industry started producing antibiotics now coming onto the market,” he says. “We’re in the same position with KPCs as we were with staph aureus 15 years ago, except that the pharmaceutical industry isn’t rushing to produce new drugs.”’

NDM-1, CDC, Pharma


Meier, Barry, “Supreme Court to Consider Vaccine Case,” NYT last checked 10/27/2010, October 11, 2010.

  1. “At issue is whether a no-fault system established by Congress about 25 years ago to compensate children and others injured by commonly used vaccines should protect manufacturers from virtually all product liability lawsuits.”
  2. “The law was an effort to strike a balance between the need to provide care for those injured by vaccines, some of them severely, and the need to protect manufacturers from undue litigation.”
  3. “Under the 1986 National Childhood Vaccine Injury Act, such claims typically proceed through an alternative legal system known as “vaccine court.” Under that system, a person is compensated if their injury is among those officially recognized as caused by a vaccine. That person, or their parents, can choose to reject that award and sue the vaccine’s manufacturer, but they then face severe legal hurdles created by law to deter such actions.”
  4. “Federal data shows that $154 million was paid in fiscal 2010 to 154 claimants involved in vaccine court proceedings. That figure was significantly higher than in preceding years and reflected several unusually high awards, officials involved in the program said.”
  5. “In the five preceding fiscal years, an average of $68 million in compensation was paid out on an annual basis, federal data indicates. A compensation fund is financed by an excise tax on vaccinations.”
  6. “The case to be heard on Tuesday involves an 18-year-old woman, Hannah Bruesewitz, who suffered seizures when she was 6 months old and subsequently suffered developmental problems, her parents say, after receiving a type of D.T.P. vaccine that is no longer sold. The D.T.P. vaccine protects against three potentially deadly childhood diseases: diphtheria; pertussis, which is also known as whooping cough; and tetanus.”
  7. “Initially, Ms. Bruesewitz’s parents brought a claim on her behalf to the vaccine court, but the severe injuries that she reportedly suffered were removed from the list of those that qualified for compensation a month before the case was heard. An administrative judge in vaccine court subsequently rejected her claim, so her parents filed a product liability lawsuit against Wyeth, a Pfizer unit that had acquired the vaccine’s manufacturer, Lederle Laboratories.”
  8. “The Supreme Court review revolves around the narrow question of whether Congress in passing the Vaccine Act intended to bar lawsuits against vaccine manufacturers based on so-called design defect claims. A vaccine design defect claim essentially asserts that the manufacturer should have sold a different vaccine, which plaintiffs say would have been safer than the one used.”
  9. “James M. Beck, a lawyer in Philadelphia who defends makers of drugs and medical devices, said in a phone interview that a ruling in favor of the Bruesewitzes would allow hundreds of lawsuits asserting a link between vaccines and autism to go forward. ‘If these cases go forward, it will make it economically unfeasible for anyone to make vaccines in this country,’ said Mr. Beck.”

Vaccination, Law, Pharma


Pollack Andrew, “Antibiotics Research Subsidies Weighed by U.S.New York Times Last accessed November 11, 2010.

  1. “Worried about an impending public health crisis, government officials are considering offering financial incentives to the pharmaceutical industry, like tax breaks and patent extensions, to spur the development of vitally needed antibiotics.”
  2. “While the proposals are still nascent, they have taken on more urgency as bacteria steadily become resistant to virtually all existing drugs at the same time that a considerable number of pharmaceutical giants have abandoned this field in search of more lucrative medicines.”
  3. “The number of new antibiotics in development is “distressingly low,” Dr. Margaret A. Hamburg, commissioner of the Food and Drug Administration, said at a news conference last month. The world’s weakening arsenal against “superbugs” has prompted scientists to warn that everyday infections could again become a major cause of death just as they were before the advent of penicillin around 1940.”
  4. “For example, scientists have become alarmed by the spread from India of a newly discovered mutation called NDM-1, which renders certain germs like E. coli invulnerable to nearly all modern antibiotics. About 100,000 Americans a year are killed by infections acquired in hospitals, many resistant to multiple antibiotics. Methicillin-resistant staphylococcus aureus, or MRSA, the best known superbug, now kills more Americans each year than AIDS.”
  5. “Besides tax breaks and extra protection from competition, other ideas policy makers are considering include additional federal funding of research and guaranteed purchases by the government of new antibiotics. Measures like these are already used to encourage the development of drugs for rare diseases, through the Orphan Drug Act, and for illnesses like malaria that primarily afflict poor countries.”
  6. “The Obama administration is also taking some steps. The federal agency that oversees development of treatments for bioterrorism agents like anthrax is broadening its scope to encompass more common infections. In August, the agency, known as the Biomedical Advanced Research and Development Authority, awarded its first such “multi-use” contract, giving an initial $27 million to a company called Achaogen to develop an antibiotic that could be used for plague and tularemia as well as antibiotic-resistant infections.”
  7. “The Department of Health and Human Services is considering creating an independent fund that would invest in small bio-defense companies. Antibiotic-resistant germs would be one priority, according to a report that the department issued in August.”
  8. “The European Union is also working on a plan, based on proposals from the London School of Economics. A year ago, the United States and the European Union formed a task force on antibiotic resistance.”
  9. “Ramanan Laxminarayan, who directs the Extending the Cure project on antibiotic resistance at Resources for the Future, a policy organization, said the government should focus on conserving the effectiveness of existing antibiotics. That could be done by preventing unnecessary use in people and farm animals and requiring better infection control measures in hospitals.”
  10. “Only five of the 13 biggest pharmaceutical companies still try to discover new antibiotics, said Dr. David M. Shlaes, a consultant to the industry and the author of a new book “Antibiotics: The Perfect Storm.””
  11. “One reason is that antibiotics are typically taken for a week or two and usually cure the patient. While that makes them cost-effective for the health system, it also makes them less lucrative to drug companies than medicines for diseases like cancer or diabetes, which might be taken for months, or even for life, because they do not cure the patient.”
  12. “Another factor is that new antibiotics are likely to be used only sparingly at first, to stave off the emergence of resistance. While that might be medically appropriate, it reduces the ability of a drug company to recoup its investment, said Dr. Barry I. Eisenstein, a senior vice president at the antibiotic maker Cubist Pharmaceuticals. Another factor discouraging investment, some experts say, is that the F.D.A. recently made it harder for new antibacterial drugs to win approval.”

NDM-1, Public Health, Prophylaxis, Pharma


Editors, ”U.S. Awards Contract For Radiation Treatment Work’‘. GSN. Sept. 7, 2010.

  1. “Funding from the department’s Biomedical Advanced Research and Development Authority is to be used to develop a medical treatment which uses myeloid progenitor cells, which can develop into any type of blood cell. The medication, CLT-008, is intended to foster the growth of and assist the body’s progenitor cells, according to an agency release.”
  2. “The Biomedical Advanced Research and Development Authority also approved millions of dollars in new funding for additional work on a treatment for plague and tularemia — two disease agents classified as potential bioterrorism threats, according to a press release.”
  3. “The antibiotic could be used against tularemia and plague infections as well as more common illnesses such as pneumonia that are growing increasingly resistant to antibiotics.”
  4. “”This new antibiotic is part of our push against antibiotic resistance for certain bacterial infections, and at the same time could provide a new treatment for plague and tularemia biothreats””

Bioterrorism, Biosafety, Public Health, Emergency Response, Pharma, Drug Resistance, Biodevelopment, Biotechnology, Quarantine






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