President Bush nominates top White House aide as FDA chief

The long search for a new commissioner of the US Food and Drug Administration (FDA) ended in early October 2002. However, the appointment of Dr Mark B. McClellan (with a medical degree from Harvard and a PhD in economics from the Massachusetts Institute of Technology), the President’s top health-policy adviser, has still to be confirmed. The previous commissioner, Jane Henney, who was appointed by the Clinton administration, had approved the ‘morning-after pill’, and, even if she had wished to stay on, was therefore unacceptable to the conservative anti-abortion Bush administration. With an annual budget of US$1.7 billion and over 10 000 employees, the FDA has approval authority in the USA over all pharmaceutical drugs, medical devices, and their advertising and labelling, 80% of the food supply, and veterinary feed and drugs. The FDA is regularly under attack, from various quarters, either as an impediment to pharmaceutical innovation or as a compliant tool of pharma. Experienced in government at high levels, politically colourless, having served in the Clinton administration before joining the Bush administration, Dr McClellan has no known ties to the pharmaceutical industry. As for experience, Dr McClellan held associate professorships in both economics and medicine at Stanford University, where he was an attending physician in the health services programme and director of the programme on health outcomes research. During the Clinton administration, Dr McClellan served as deputy assistant secretary of the Treasury for Economic Policy, and for the past 18 months, on the three-member White House council of economic advisers. From that perch, he has served as the Bush administration’s chief policymaker on health issues, leading the campaign—so far unsuccessful—for government subsidy of pharmaceutical drugs for senior citizens and for tax credits to help the uninsured obtain medical cover.

An alternative approach to the Hahnemann theory of infinitesimal dilution

Two drug companies had knowledge that a pharmacist was diluting cancer drugs as long as 3 years before his arrest, according to a motion filed by patients’ attorneys. The motion said that neither Eli Lilly & Co. nor Bristol-Myers Squibb Co. had contacted the government about their discovery concerning Robert Courtney, leading to the untimely deaths of "countless cancer patients". The former Kansas City pharmacist was arrested last year and pleaded guilty in February 2002 to 20 federal criminal charges of tampering with, adulterating and misbranding chemotherapy medications. He has since admitted diluting 72 drugs, dating back to at least 1992. He faces hundreds of lawsuits claiming wrongful death and injury. According to the motion, the two companies detected possible fraud in 1998 using detailed tracking systems that determine where their drugs are being sold, in part to uncover counterfeiting schemes such as Courtney’s. Judy Kay Moore, a spokeswoman for Eli Lilly, dismissed the new allegations. "These plaintiffs’ attorneys have cut and pasted, embellished and mischaracterized the documents and sworn testimony", she said, according to various press reports. Eli Lilly sales representatives are said to have noticed in 1998 a large difference between how much gemcitabine Courtney was buying and how much oncologists said they were buying from him. Eli Lilly found that Courtney’s pharmacy was dispensing more than twice as much gemcitabine to patients of a single Kansas City practice as Eli Lilly was selling to all retail pharmacists in Kansas in 1998, the motion states.

Federal authorities have suggested Courtney’s scheme may have affected as many as 400 doctors, 4200 patients and 98 000 prescriptions. He has not been sentenced, but his plea agreement calls for him to serve 17.5–30 years in prison. In early October 2002, both Eli Lilly and Bristol-Myers Squibb settled more than 300 lawsuits at undisclosed terms.

Elderly patients are being left out of critical cancer research and not offered the best treatment options

Despite the median age of cancer patients reaching 70-years-old, leading oncology experts from around the world say elderly patients are often excluded from important clinical trials and are not being offered the same treatment options as younger patients. The experts, attending the 7th International Conference on Geriatric Oncology, Boston, MA, have called for equity in access to treatment options and additional research among elderly cancer patients. New research is particularly needed in elderly patients with co-morbid conditions, such as heart disease, and in those taking multiple medications that can often interact adversely with one another. "Cancer is an increasingly important problem in the elderly, yet there is a lack of research focusing on this important group", said Dr Paul Calabresi of Providence, RI, and past-president of the International Society of Geriatric Oncology (SIOG). "In the next 10 years there will be an exponential increase in patient numbers. We can no longer ignore this important patient population", Calabresi added.

Dr Silvio Monfardini (Padova, Italy), recently elected president of SIOG, said, "Elderly cancer patients must be offered the same treatment options as younger patients, even if treatment of the elderly is less cost-effective . . . It is wrong and unethical to discriminate against a patient because of their age". Prof. Monfardini, past-president of ESMO, also chaired a session dedicated to these matters during the ESMO meeting in Nice, which ESMO recognizes as an important issue.

Highlights of the Boston conference included a presentation on the guidelines for treating anemia in elderly cancer patients. Discussing patient care, Dr Matti Aapro (Genolier, Switzerland) stated that there is a clear need to continue the pioneering work of the US National Cancer Network in demonstrating that all elderly patients need to be treated appropriately in order to ensure normal hemoglobin levels. In addition, Dr Lazzaro Repetto (Instituto Nazionale di Riposo e Cura per Anziani) presented on the use of the European Organization for Research and Treatment of Cancer Task Force in the Elderly (EORTC-TFE) guidelines on hematopoietic growth factors. Dr Repetto also confirmed that the US guidelines for the use of G-CSF (a white blood cell growth factor) are valid for elderly patients. For additional information about SIOG, visit www.siog.org.

President Bush gives a remarkable speech and announces an increase in cancer research funding

At a recent meeting at the White House, President Bush made important statements, which show how openly the Americans face the issue of cancer and also the importance they give to funding adequate research facilities. Europe still has no effective coordination of cancer research efforts. President Bush stated: "Overall, more than 60% of the Americans diagnosed with cancer today can expect to be alive in 5 years. Today, 8.9 million Americans are cancer survivors. Every life, every name, is a triumph of medicine and a triumph of hope. Given the statistics, the good news about cancer survivors also presents a real challenge to our country. Cancer survivors need high-quality follow-up care to detect early signs of recurrence and to treat other problems that come from the illness and its treatment. The National Cancer Institute, under Dr von Eschenbach’s lead, is committed to improving the long-term care for all survivors of cancer, and especially for our children. NCI-funded scientists are exploring new ways to enhance high-quality, follow-up care. We must also accelerate our progress against cancer itself. More than 1500 Americans die from cancer every day. Three out of every four American families will have at least one family member diagnosed with cancer. Scientists, health care providers and public health professionals are working tirelessly to find cures for this disease, and they need our full—full support. My 2003 budget would increase funding for cancer research by $629 million, for a total investment in cancer research throughout the National Institutes of Health of more than $5 billion. In order to win the war against cancer, we must fund the war against cancer. Prevention is critical. And we’re just beginning to make progress on cancer prevention.

Nobel prize for "Physiology or Medicine" 2002: when a worm brings you under the spotlight

Sweden’s Karolinska Institute announced on 7 October 2002 that Sydney Brenner and John Sulston of the UK and Robert Horvitz of the USA have won the 2002 Nobel Prize for Medicine. This year’s Nobel Laureates in Physiology or Medicine have made seminal discoveries "concerning the genetic regulation of organ development and programmed cell death", shedding new light on the etiology of many diseases. The three share the near $1 million prize money.

By establishing and using the nematode Caenorhabditis elegans as an experimental model system, it became possible to follow cell division and differentiation from the fertilized egg to the adult. The Laureates have identified key genes regulating organ development and programmed cell death and have shown that corresponding genes exist in higher species, including man. Sydney Brenner (Berkeley, CA) established C. elegans as a novel experimental model organism. This provided a unique opportunity to link genetic analysis to cell division, differentiation and organ development, and to follow these processes under the microscope. Brenner’s discoveries, carried out in Cambridge, UK, laid the foundation for this year’s prize. John Sulston (Cambridge, UK) mapped a cell lineage where every cell division and differentiation could be followed in the development of a tissue in C. elegans. He showed that specific cells undergo programmed cell death as an integral part of the normal differentiation process, and he identified the first mutation of a gene participating in the cell death process. Robert Horvitz (Cambridge, MA) has discovered and characterized key genes controlling cell death in C. elegans. He has shown how these genes interact with each other in the cell death process and that corresponding genes exist in humans.

For more information on this and other Nobel prizes see www.nobel.se.