Monday, January 26, 2009
Sunday, January 25, 2009
The approval came just 2 days after the inauguration of President Barack Obama, causing some to speculate that the new administration is set to remove some of the financial obstacles faced by research in this area. Soon after taking office for his second term in 2001, President George W Bush announced, 9th August, a restriction on federal funding for embryonic stem-cell research. Although not a ban of the research per se, the lack of federal funding was variously described as leading to more or less the same result. In 2oo6, President Bush vetoed H.R 810 / S 471 to amend the Public Health Service Act to provide for human embryonic stem cell research. President Barack Obama had been expected to reverse the ban soon after taking office this year.
Saturday, January 24, 2009
Tuesday, October 14, 2008
- information to patients on pharmaceuticals
- pricing policy
- relative effectiveness.
A European Parliament conference Tuesday heard cautions against the proposed law simply resulting in proxy advertising for the pharmaceutical industry. Secretary General of the Pharmaceutical Group of the European Union (PGEU), John Chave (pictured at right), is not convinced of the need for the legislation: "If, however, the laws are to be changed, it is of fundamental importance that public confidence in the integrity of the information provided is maintained. The pushing of information by the industry should never be a proxy form of promotion or advertising. The sole justification for change can only be to help patients and not to grant more commercial freedom to the pharmaceutical industry." In its submission to the public consultation, the PGEU identified problems with self-regulation in the industry, among other concerns.
Monday, October 13, 2008
Despite research developments and new products, inequities in access to medicines continue: "We noted that despite the gains, the epidemic continues to outstrip our best efforts. Only one-third of those who need antiretroviral treatment in low-and middle-income countries are getting it." The Millenium Development Goal 6 is specifically concerned with achieving universal access to HIV/AIDS medicine by 2010 and the halt of the spread of the disease by 2015.
The firms that met with the UN Secretary-General included Abbott Laboraties, which has been in the press for its controversial pricing of Norvir following the marketing of its newer drug, Kaletra.
Access to information is also an important factor in achieving these goals, and China is recognising the significance of data-sharing in disease control. An international team of researchers investigating HIV infections in southern China has been granted full access to government medical data, as reported in Nature. This transparency is advocated as part of China's overall strategy to reach its goal of limiting total infections to 1.5million by 2010.
Sunday, October 12, 2008
The £25,000 Wellcome Trust Book Prize (making it one of the richest literary awards) will go to the author of an outstanding literary work engaging with perspectives on medicine, health and illness.
Medicine has always been an important literary vehicle, from Bram Stoker's Dracula to Gabriel Garcia Marquez's Love in the Time of Cholera, and this new prize will reward these literary interrogations of attitudes to sickness, health and the medical profession.
The panel, chaired by comedian and former psychiatric nurse, Jo Brand (pictured at right), will consider books published between now and September 2009. Speaking to the Guardian, Jo Brand said, "We are looking for books like One Flew over the Cuckoo's Nest [one of Brand's personal favourites], that have illness at the centre of the story."
Jo Brand is joined on the panel by Quentin Cooper (BBC science journalist), Brian Hurwitz (D'Oyly Carte Professor of Medicine and the Arts, Kings College London), Gwyneth Lewis (Welsh author and poet) and Raymond Tallis (former Professor of Geriatric Medicine at the University of Manchester and Consultant Physician, now full-time writer and Visiting Professor to St George's Hospital Medical School, University of London).
The shortlists of 6 works will be announced at next year's Times Cheltenham Literary Festival in October.
Thursday, August 28, 2008
Although the Bill still has to go before the full Parliament in September, it is expected to be passed into law.
The amendment establishes a new State regulatory authority, the South African Health Products Regulatory Authority, replacing the Medicines Control Council (MCC). The MCC is currently the national competent authority for the approval of new medicines to be marketed in South Africa.
The controversial aspects of the new law are its granting of ultimate decision-making authority to the Minister, its changes to the appeals process and ultimate authority on marketing decisions.
Under the new section 15 "Certification and registration of products", the Minister can choose to refuse approval of a new drug for marketing, after it has passed clinical trials and has been cleared by the Regulatory Authority. The Minister can refuse to register a product if it is considered contrary to the "public interest" - in this decision the Minister is to take account of:
- public health interests;
- economic interests in relation to health policies;
- strategic interests in relation to health policies;
- the need and desirability for such produch; and
- generally whether the public would be best served by such registration.
The amendment to section 24 and new section 24A establishes a new appeals process which allows opposition on any grounds (not just scientific) to the decision of the Regulatory Authority or the Director-General. But it appears that the amendments do not provide for appeal against the decision of the Minister.The Bill has been strenuously opposed by pharmaceutical companies and patient groups alike. It is described as replacing the role of the regulatory authority with an appeals process and a Ministerial decision. Critics have suggested that this leaves the process vulnerable to abuse, mis-use by competitors and interference from policy positions.
In particular, South Africa's track record on the approval of anti-retrovirals is very worrying if this system goes ahead. At the XVI International AIDS Conference 2006, the UN Special Envoy criticised South Africa's approach to prevention and treatment, and others called for the resignation of the Health Minister, Dr Manto Tshabalala-Msimang. The Health Minister had insisted that the South African display include garlic, lemons and African potatoes (pictured at right). Soon after the international meeting and with ongoing public pressure, South Africa appeared to respond with a change in policy but with the removal last year of more progressive Deputy Health Minister, Nozizwe Madlala-Routledge. AIDS activists called the sacking "a dreadful error of judgment." Earlier this month the Health Minister declined to attend this year's XVII International AIDS Conference in Mexico City.
Dubbed as Dr Beetroot, Dr Garlic and worse, there is a dedicated "SackManto" website and in 2007 scientists wrote a joint letter of protest to President Mbeki. But he has continued to give the Health Minister's position his full support.
Treatment Action Campaign (TAC) former chairman, Zackie Achmat, has stated that the new structure will compromise the independence of the Regulatory Authority and "will leave it vulnerable to political interference." TAC has opposed the Bill and has declared it will take action to prevent the Bill becoming law. Many groups are said to be prepared to take legal action if the Bill is passed into law in September in what is described as one of the most important pieces of health legislation in South Africa in recent years.