Select Committee on Science and Technology Written Evidence


Visit to the United States of America, 20-25 January, Principal Points Arising

  1.  The Committee visited a variety of institutions in the United States between the 20 and 25 January. Members present were Lord Haskel, Lord Oxburgh, Lord Soulsby of Swaffham Prior and Baroness Walmsley. They were supported by the Specialist Adviser, Professor Julius Weinberg and the Clerk, Rebecca Neal.

MONDAY 20 JANUARY

  2.  The Committee was accompanied by Deputy Consul General, Steve Collier and Trade Officer Mark Borst.

  3.  The Committee met Dr Jeffrey Koplan, Senior Advisor, South Eastern Center for Emerging Biological Threats (SECEB) Dr Jyoti Somani, Dr James Steinberg, Faculty member of the Division of Infectious Disease at Emory University, Dr Mark Feinberg and Dr Jeffrey Dunbar, Senior Business Manager of the Division of Infectious Disease at Emory University.

  4.  SECEB had recently been established to co-ordinate and consolidate research and other activities in order to improve the response to biological threats. It fostered links with universities and state health departments to develop relationships between academics and state health departments. The infrastructure costs had been borne by Emory University.

  5.  In the far-ranging discussion the following points were made:

    (a)  The National Institutes of Health funded much research, including that relating to public health, and therefore had a significant impact on the research agenda by setting funding priorities;

    (b)  in order to be able to address public health threats effectively academic and public health institutions needed to collaborate and carry out joint research;

    (c)  public health aspects of infectious disease needed to be closely integrated both with clinical infectious disease and microbiology and with the public health practice rather than viewed as a distinct;

    (d)  social and political perspectives played a significant role in establishing and the tackling of public health priorities;

    (e)  rising debt amongst medical graduates had impacted upon recruitment in public health as posts in this area were less well remunerated than other medical specialities;

    (f)  new and more rapid diagnostic tools were needed but no body had taken responsibility for fostering their development. Perhaps governments should take the lead and provide pump priming funds;

    (g)  constraints were being placed on medical researchers by US data protection legislation;

    (h)  frequency, timeliness and quality of disease reporting by local authorities was variable because of the large and diverse number of paper based surveillance systems;

    (i)  the CDC was a purveyor and brander of information;

    (j)  there were 70-80 ID physicians in Atlanta area; very few had laboratory management responsibility. An increasing number of microbiology laboratories were managed by non medical PhD Scientists;

    (k)  there was a shortage of medical microbiologists and laboratory technicians;

    (l)  many hospitals did not have on-site microbiology laboratories but sent specimens elsewhere; for example an Atlanta hospital used a Florida based laboratory;

    (m)  it could be useful to introduce public health messages into the entertainment media. There had recently been a story about the MMR vaccine on a popular TV show;

    (n)  medical students did not have significant exposure to infectious disease medicine, with only about 10 to 20 per cent rotating through ID wards;

    (o)  infectious disease physicians would not see every patient with serious infectious diseases. A consultation with an ID physician depended on whether the lead physician called in ID advice; and

    (p)  the PHLS was highly regarded by many in the US.

Emory Vaccine Center

  6.  The Committee met Lillian Kim and Dr Rama Amara and toured the purpose-built vaccine research centre based at Emory University. The following points were raised:

    (a)  the centre brought together basic science, pre-clinical and clinical science in one physical setting;

    (b)  there was significant value in having a purpose built primate centre integrated with basic immunological and applied vaccine research facilities;

    (c)  there was concern about the future of vaccine development because of regulatory problems particularly the safety requirements for new vaccines and an increasing amount of anti-vaccine feeling in the US public.

TB Centre at Grady Hospital

  7.  The Committee met Dr Henry Blumberg, an ID physician based at Emory University and an Epidemiologist at Grady Hospital, and his colleague Dr King and went on a tour of a TB ward. Grady was a public teaching hospital based in downtown Atlanta with 1,000 beds.

  8.  The following points were made during the meeting:

    (a)  about 25 per cent of all new TB cases recorded in Georgia in a year (c125 cases) were diagnosed at Grady Hospital and 35 per cent of these patients were co-infected with HIV;

    (b)  Grady had 50 isolation rooms, 26 of which were respiratory isolation rooms. Ninety-nine per cent of patients using these rooms had TB. This was probably the largest number of isolation rooms in one hospital in the USA;

    (c)  it was important to have a social perspective when treating patients with TB, most of whom were socially deprived and often homeless. Social workers were based in the hospital to assess patient needs. Patients with TB were often placed on an outreach programme where they were provided with a free motel room and food in exchange for completing anti-TB drug treatment;

    (d)  developing rapid diagnostic tests for TB was important but no body was taking responsibility for this activity;

    (e)  prisoners were a group of particular concern. Although prisoners were screened on entering prison many would not be there long enough to complete treatment, leaving them infected and contributing to antibiotic resistance. Holding jails did not screen inmates at all;

    (f)  there were some concerns about the lack of infectious disease training for doctors, with very few general medical students rotating onto TB wards. ID physicians only completed one month of microbiology training;

    (g)  ID physicians did not necessarily see all patients with TB. General physicians might and often did treat simple cases themselves. At Grady a nurse saw all patients prior to discharge in order to confirm that patients did not have TB and that they had been correctly treated.

TUESDAY 21 JANUARY

Centers for Disease Control and Prevention (CDC)

  9.  The Committee was accompanied by Steve Collier and Mark Borst.

  10.  The Committee met Dr Ken Castro, Dr Nancy Cox, Mr Rob Cox, Dr Julie Gerberding, Dr Jim Hughes, Mr Dennis McDowell, Dr Dixie Snider, Dr Dan Sosin, Ms Cathy Spruill, Dr Steve Ostroff, Mr Tom O'Toole, Ms Kathryn O'Toole, Ms Wanda Walton, Dr Charles Wells and Dr Melinda Wharton.

Background

  11.  The Committee heard that the CDC was a federal organisation based in the Department of Health and Human Services. CDC had responsibility for developing and applying methods of disease prevention and control. Much of the CDC's current surveillance activity was driven by its response to the Institute of Medicine's report, Emerging Infection, published in 1992.

  12.  CDC had an estimated $600 million annual research budget. Some of this was earmarked research funding and some was carved out of core funds.

  13.  The following points were made during presentations and discussion.

Importance of collaborative work

    (a)  Effective infectious disease control services required clinicians to understand about and work closely with experts in public health.

    (b)  There should be strong links both between laboratory scientists and epidemiologists and between experts in human and animal infection.

    (c)  Surveillance should be linked to the response capacity rather than operating in isolation.

    (d)  There was a need in the United States to rebuild links between local, state and national surveillance. This relationship had declined as a result of under-investment.

    (e)  The importance of collaborative work had been highlighted by the recent emergence of West Nile virus encephalitis. Specifically:

      (i)  this disease could perhaps have been identified earlier had there been better communication between the veterinarians and those with responsibility for human health;

      (ii)  there had been a significant number of agencies involved in attempting to control the spread of West Nile virus, creating uncertainty about which should take the lead;

      (iii)  counties, rather than federal or state organisations, were responsible for deciding whether or not to spray anti-insecticides, potentially leading to different policies about spraying across the US.

Emerging threats and bioterrorism

    (a)  Systems that would enable the USA to respond to bioterrorism effectively would also contribute to routine public health activities ("dual use").

    (b)  Attention needed to be paid to developing surge capacity in case of a sudden outbreak. For example there was a shortage of entomologists (experts in insects) who were crucial to providing expertise in cases of insect-borne disease.

    (c)  The CDC was fortunate with recent events in having been able to call on extra support in academic departments and the Department of Defense.

    (d)  The H5N1 influenza outbreak in Hong Kong had revealed the lack of pandemic preparedness. In particular:

      (i)  effective response to a `flu pandemic would require rapid characterisation of the virus and pilot production and subsequent scaling up to industrial production of a vaccine;

      (ii)  despite developing candidate vaccines and pilot lots there was limited global production capacity with only two manufacturers in the US;

      (iii)  it would take four to nine months to produce a vaccine and current global travel patterns could mean that any epidemic were well established within this time. Even current capacity of vaccine production would be inadequate for the demand;

      (iv)  it was necessary to consider how anti-viral treatment should be used in a `flu pandemic. Anti-virals were expensive to produce and would have to be stockpiled;

      (v)  it would be necessary to have international co-ordination of distributing both vaccines and anti-virals;

      (vi)  it was important to improve the timeliness of recognising an epidemic. As there were concerns that a `flu pandemic could develop in China, the WHO, with the support of CDC and others, were helping the Chinese to develop `flu surveillance systems.

    (e)  The UK was one of the few countries to have had a formal national pandemic response plan at the time of the H5N1 influenza outbreak.

Training

    (a)  The CDC had an Epidemic Intelligence Service (EIS), which required two years of formal training in field epidemiology and attracted people from a variety of backgrounds with different skill sets, including vets, physicians, PhD epidemiologists and public health nurses.

    (b)  The EIS helped to create strong relationships within the alumni who went into a variety of roles in the public health and academic sectors across the USA. EIS Officers played significant roles in preventing disease epidemics.

Information Technology and management

    (a)  The CDC was currently developing systems for more effective information management, including capturing data from within clinical settings. In particular, they were considering possible uses of hand-held computerised devices.

    (b)  It was important to:

      (i)  tap routine data wherever possible;

      (ii)  use both formal and informal sources of data for example routine data as well as word of mouth, newspaper reports etc;

      (iii)  collect only what was needed and would be used;

      (iv)  have a single rather than multiple input whenever possible.

    (c)  Whilst not all data required personal identifiers some did in order to carry out effective disease control. This was now difficult given data protection legislation.

External Relations

    (a)  More press officers were currently being appointed by the CDC in order to disseminate public health messages. It was also currently training scientists in communication skills.

    (b)  The CDC was appointing communication experts to run focus groups in order to establish public concerns.

    (c)  The CDC worked hard to build relationships with the legislature through regular briefings about developments in public health and medical science.

    (d)  It was viewed important to have a well-informed media so the CDC carried out training for journalists.

Vaccines

    (a)  It was important to harmonise advice about vaccine schedules and side effects from authoritative bodies in order to avoid confusion in the physician community and panic in the general public.

    (b)  The US had a no-fault compensation scheme for recognised side-effects from vaccines. However this scheme covered very few side-effects. There was on-going discussion as to whether the burden of proof should be lessened.

International Perspective

  14.  Communicable disease was a global phenomenon and therefore attempts to control it must also have an international perspective.

    (a)  In 1999 CDC was authorised by Congress to engage in an international effort against tuberculosis and there were now funding streams for people working abroad.

    (b)  TB provided a good example of the need for an international perspective with a large proportion of people in the US with TB being foreign born. One seventh of all new drug-resistant TB cases in the US were from Latvia.

WEDNESDAY 22 JANUARY

Washington DC

  15.  The Committee was accompanied by Mr Chris Pook, First Secretary (Science and Technology).

  16.  The Committee met Dr Eve Slater, Assistant Secretary for Health and Head of Office of Public Health and Science, part of the Health and Human Services Department, Adm. Ken Moritsugu, Deputy Surgeon General, Bruce Gellin, Director of National Vaccines Program and Frank Patzman, Office of the Assistant Secretary for Health.

  17.  The following points were raised in discussion.

    (a)  The Health and Human Services Department had recently been reorganised so that the heads of the National Institutes of Health, Centers for Disease Control and the Food and Drug Administration all reported directly to the Secretary.

    (b)  A key concern was integration between federal and state activity and communicating federal priorities to the states. One way in which this had been tackled was through publishing public health targets (467) in Healthy People 2010. These had been identified in consultation with states and federal agencies. It was to be hoped that this would raise the profile of public health.

    (c)  Information gathering needed to be improved with the main barrier to improvement being shortage of resources.

    (d)  Data protection legislation had prevented some public health research being carried out. The US intends to introduce legislation to simplify data protection law.

    (e)  Whilst data could be made anonymous with unique identifiers in some cases there would still be difficulty with deductive disclosure, for example rare conditions in rural areas.

THURSDAY 23 JANUARY

  This meeting focused on the National Institute of Allergy and Infectious Diseases (NIAID) tuberculosis and West Nile virus research programs. NIAID is a component of the National Institutes of Health (NIH).

  18.  The Committee was accompanied by Chris Pook. The Committee met Dr John La Montagne, Deputy Director of NIAID, Dr Caroline Heilman, Director of the Division of Microbiology and Infectious Diseases, NIAID, Dr Christine Sizemore, NIAID's Tuberculosis Program Officer and Dr James Meegan, NIAID's West Nile Virus Program Officer.

  19.  NIAID supports a broad tuberculosis research portfolio, which encompasses prevention and treatment efforts. NIAID also supports research endeavours to address the diagnosis and, prevention and treatment of West Nile virus. Issues discussed included:

    (a)  NIAID's research program encompasses infectious, immunological, and allergic diseases. NIAID's overall budget for 2003 is the second largest among the institutes and centers that comprise the NIH. Eighty-five per cent of the Institute's budget goes to outside researchers through a combination of grants and cooperative mechanisms, including contracts;

    (b)  research priorities are set through meetings with the White House and Congress, scientists, the research community, and other institutions, such as the Institute of Medicine;

    (c)  infectious diseases have a significant economic impact and a global nature;

    (d)  the NIAID has a number of different mechanisms for funding research. Of particular interest is the Small Business Innovation Research (SBIR) program, which attempts to stimulate research that may not otherwise be carried out because of its unprofitable nature. Businesses were allowed to retain intellectual property rights but were obliged to make every effort to deliver a product to the market; and

    (e)  areas that need to be stimulated include computer and mathematical modelling of infectious diseases, molecular and genetic epidemiology and information technology.

Institute of Medicine

  20.  The Committee met Dr Rose Martinez, Director of Health Promotion and Disease Prevention, Dr Mark Smolenski and Stacy Knobles.

  21.  The Institute of Medicine aimed to influence federal agencies rather than individual health professionals. It was independent of government and the majority of its money derived from contracts from agencies.

  22.  The following points were raised in discussion:

    (a)  the IoM would publish in March 2003 a consensus follow-up review to its 1992 report, entitled Emerging Infections: Microbial Threats to Human Health in the United States. This would include examining the benefits of and concerns about syndromic surveillance;

    (b)  it was difficult to standardise state-to-state data exchange which led to variations in the nature and accuracy of reporting. There was not a standardised system for reporting disease;

    (c)  state public health laboratories generally had effective relationships with CDC;

    (d)  research and development of rapid diagnostics was an area of concern with no body taking responsibility for this. Also these tests were often expensive; and

    (e)  there was a shortage of ID physicians and insufficient ID training for physicians and there was concern about the low numbers of microbiologists and entomologists.

Infectious Disease Society of America

  23.  The Committee met Dr John Bartlett, Dr Henry Masur, Dr Thomas Quinn and Dr Mike Scheld of the Infectious Disease Society of America. The following points were raised:

    (a)  the relationship between federal government, the states, the CDC and other relevant organisations was key in the fight against infectious disease but had improved recently. This was particularly relevant for developing new antiobiotics to deal with resistant microorganisms;

    (b)  the Government needed to make a clear commitment to fighting infectious disease and attempt to stimulate applications to become public health and infectious disease physicians. These were both relatively low paid specialities and therefore had traditionally had difficulties in recruiting;

    (c)  it was important to have one body taking the lead in pushing the public health and infectious disease agenda;

    (d)  the majority of laboratories in the US were not run by medical microbiologists but by PhD scientists. Most laboratories are run by pathologists who often have little knowledge of or interest in microbiology; and

    (e)  development of vaccines might be stimulated by extending length of patents. However some issues could not be solved by patent extension. These include the negative image of vaccines by the public, low profits in vaccines and concerns about liability.

New York

  24.  The Committee was accompanied by Leslie Slocum, British Consulate.

  25.  The Committee met for dinner at the residence of the Consul General, Sir Thomas and Lady Harris, Mr Gordon Cameron, President, Acambis Inc.; Dr. Thomas Frieden, Commissioner New York City Department of Health and Mental Hygiene; Dr Michael Garvey, The Bobst Hospital, Animal Medical Center; Dr Luis Montaner, Wistar Institute; Alice Pomponio, Vice-Consul, British Consulate-General, Boston; Dr Lee Reichman, New Jersey Medical School National Tuberculosis Center; Dr Stephen C Schoenbaum The Commonwealth Fund and Mr Mark Sinclair, Consul, British Consulate-General, Boston.

  26.  A wide variety of issues were discussed including collaboration between state and federal organisations, international collaboration, vaccine development and control of tuberculosis.

FRIDAY 24 JANUARY

New York City Department of Health and Mental Hygiene

  27.  The Committee met Dr Marcelle Layton, Assistant Commissioner for the Communicable Disease Programme, Dr Sonal Munsiff, Director of New York City TB Control Program.

Tuberculosis in New York

    (a)  New York City had a programme to identify individuals with latent TB. Physicians were required to report TB and, if the Department requested, had to provide information about those patients. The 1993 City Health Code allowed New York City to involuntarily detain individuals in a hospital if they were suspected of being infected with TB in order to prevent transmission. It could not force individuals to take treatment;

    (b)  this programme was costly. It had however proved to be very successful with rates of TB dropping to 20 per cent of the 1993 figure. 1,000 individuals were currently on treatment with only seven incarcerated;

    (c)  New York City and New York State had needed to work closely together to implement and carry out the TB programme;

    (d)  New York City carried out a significant amount of Directly Observed Therapy (DOT). DOT increased from 30 per cent to 70 per cent of individuals with TB in NYC. NYC also ran a TB shelter for men where patients could live during their treatment;

    (e)  about half of all DOT was carried out in the field rather than in clinics. Non-medics had been appointed as outreach workers, each looking after 10 patients;

    (f)  there were significant side-effects to treatments given for multi-drug resistant TB; and

    (g)  ideally there would be more outreach workers and hospitals would provide clinic services rather than admitting people with TB.

West Nile virus encephalitis

    (a)  patients had presented with peculiar symptoms in the Queens area of New York. When the Department had been informed they carried out extensive interviews with patients and families, concluded that it could be a mosquito borne disease and sent an entomologist to Queens;

    (b)  the response to this emerging disease required significant co-ordination with the Sanitation Department, which was responsible for spraying anti-mosquito agents and clearing tyre dumps, which were a breeding ground for mosquitoes;

    (c)  there was a need for effective sharing of information between those responsible for human health and the veterinary authorities; Birds had been dying of strange illness for three months prior to human infection with West Nile but this was only investigated after human infection;

    (d)  preventative measures should be based on surveillance of mosquito and bird populations rather than on human surveillance; and

    (e)  the Department had been very pro-active about informing the public as soon as it had been established that the illness was mosquito-borne.

Model TB Center, Harlem Hospital

  28.  The Committee met Dr Wafaa El-Sadr, Chief of Infectious Disease; Dr Paul Colson, Program director; Dr Cyrus Badshah, Medical Director; Ms Linda Smith, Head Nurse; Mr Bill Bower, Head of Education and Training; Mr Kenneth Holley, Health Educator; Mr Mark Torres, Senior Health Educator.

    (a)  This was one of three model TB centres in the US, the others being based in New Jersey and San Francisco. It aimed to develop innovative ways of treating TB, education and training health professionals, patients and the public.

    (b)  Harlem had historically a large incidence of TB and significant numbers of patients who did not complete treatment.

    (c)  Aims of the Center were to:

      (i)  improve treatment completion rates;

      (ii)  manage latent as well as active TB;

      (iii)  reach out to new patient populations and develop relationships with new professional partners such as community physicians, international medical graduates working in Harlem and traditional healers;

      (iv)  conduct behavioural studies;

    (d)  in order for DOT programmes to work, patients needed lots of support from staff and therefore the Center had developed a "surrogate family" model of treatment. This was clinic based; patients could drop in and "hang out" in clinics. There was a sense of family with staff and patients developing close relationships through regular contact. Group incentives were also employed, such as celebrating birthdays and public holidays together;

    (e)  more work needed to be carried out on how to identify patients who were infected with both TB and HIV;

    (f)  there was an extensive community outreach programme with workers attending street fairs, local churches;

    (g)  the Center was keen to employ peer workers from within the community. There were staff, both who worked in the center and in an outreach capacity, who had originally been patients. This provided them with a useful insight into the difficulties of completing often unpleasant and long courses of treatment;

    (h)  patients who attended the clinic for DOT were provided with food vouchers and travelcards; and

    (i)  treating and identifying latent TB in illegal immigrants provided a challenge as these individuals were often very fearful of institutions.


 
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