Originally published in August 2003 icon
The pharmaceutical company, AstraZeneca, pleaded guilty in a court case in Wilmington, USA on a charge of health care fraud and agreed to pay $355 million to settle criminal and civil accusations that it engaged in a nationwide scheme to illegally market a prostate cancer drug. The US government charged that the company’s employees had given illegal financial inducements to as many as 400 doctors across the country to persuade them to prescribe the drug, Zoladex. Those inducements included thousands of free samples of Zoladex, worth hundreds of dollars each, which the physicians then apparently billed to Medicare and other US federal health care programmes, prosecutors said. The prosecution also stated that the company gave doctors financial grants, paid them as consultants and provided free travel and entertainment too.
The $355 million that AstraZeneca, a British company, agreed to pay, is one of the largest ever settlements in a heath care fraud case. The company will pay about $266 million to the federal government to settle most of the civil accusations while an additional $25 million will go to settle accusations that it defrauded the Medicaid programs, which are partly financed by the individual states. A further $64 million approximately is a criminal fine. "We want doctors to prescribe what is best for their patients and not what is best for the doctor’s bank account," Richard G. Andrews, first assistant United States attorney for the District of Delaware, said at a news conference.
He and other prosecutors said the government’s action should send a message to all pharmaceutical companies that such conduct will not be tolerated. Mr. Andrews said that AstraZeneca had reported false and inflated prices for Zoladex to the federal government so that doctors could earn significant profits by prescribing the drug.
Prosecutors said that they did not plan to charge any AstraZeneca employees for the illegal activities that they say began in 1991 and continued until last year. "The investigation did not discover any evidence to implicate AstraZeneca’s upper levels of management," Mr.Andrews said.
(Taken from The New York Times, 21st June 2003)
The UK’s National Institute for Clinical Excellence (NICE) has added PLDH to the approved topotecan, as a second line drug for use with advanced ovarian cancers.
NICE have suggested that PLDH has a simpler administration schedule.
A WHO-sponsored international conference held in Japan aims to map the global availability of traditional medicine to make it both more accessible and to raise awareness of treatments. The Kobe centre, which started the atlas project in 1999, hopes it will be used to improve healthcare systems, clinical research, training and the quality of traditional medicine around the world.
Breast cancer, the most common form of cancer in women worldwide, has many known risk factors ranging from age to diet, the Pill, HRT, obesity and family history. Another cropped up again in a recent study: that women with breast cancer had higher pesticide residues in their bloodstream than healthy women. In fact, women diagnosed with breast cancer were five times more likely to have DDT residues and nine times more likely to have residues of HCB (hexachlorobenzene) in their blood than a control group.
Scientists at King’s College, using a new photographic technique have shown that cancer metastasis is not simply caused by cells breaking off the tumour and then diffusing away. Early conclusions suggest that there is actually movement within the body of a cell (the cytoplasm) and that this occurs at high velocity, forcing cells to metastase.
Meanwhile, scientists at Addenbrooke’s Hospital, Cambridge,have developed an imaging technique based on a previously hidden spectrum of light to detect 85 per cent of the cancer tumours not picked up by x-rays, ultrasound or MRI scans. It will also enable tumours to be picked up much earlier.
Vitamin B-12 (cobalamin) deficiency appears linked to folate deficiency and since folate is crucial in accurate DNA replication it is no surprise that at least one research study shows women with Breast Cancer have lower vitamin B-12 levels than those without. (Choi, San g-Woon: Nutrition Review Vol 57). The problem seems to be that hitherto no really accurate tests exist for 8-12 levels in the blood. Now The American Journal of Clinical Nutrition (May - 2003) reports that Methylmalonic Acid (MMA) levels are an accurate indicator - levels below 150 pmol/L indicate B-12 deficiency.
B-12 is a very large molecule and needs to combine with an intrinsic factor normally present in the intestines for absorption. Researchers at the Turkish Military Medical Academy identified that 77% of people with 8-12 deficiency had Helicobacter pylon bacterium infection. Furthermore, it is estimated that, anyway, 50% of adults in Western countries have the infection. 11% of older people have 8-12 deficiency (Journal of American Geriatric Soc Vol 44) and early symptoms are fatigue, memory loss and mental confusion. Alzheimer’s and dementia are linked to low 8-12 (Age and Ageing Vol 23 p 334) as have been heart attacks (American Journal of Epidemiology Vol 143).
73% of vegetarians are reported to be deficient (American Journal of Clinical Nutrition Vol 70 Sept 1999) and the recommended solution is 8-12 injections if levels are found to be low.
Worryingly for all those men who have been told their prostate cancer is testosterone driven comes the news that statistically there is absolutely no connection. Nor is there any link with the number of sexual partners you may have had. Indeed being single makes you statistically less susceptible than being married or divorced. The only statistic in the Western world of relevance is your age. The incidence increases exponentially once you reach 50. (Sunday Times UK Supplement)
The International Journal of Cancer 2003 (105) reports that male hairdressers, shown to have an increased risk of bladder cancer in the 60s, are now at normal levels. (The report didn’t say whether the rest of us had merely caught up although there was some suggestion that brilliantine was carcinogenic). However, scalp and neck cancers were shown in Swedish data to be more prevalent among male hairdressers probably because they had a higher incidence of hair dye usage themselves.
Memorial Sloan-Kettering Cancer Centre have reported a new study suggesting that a drug called Erlotinib (TarcevaTM) has promising activity in patients with bronchioloalveolar cell carcinoma (BAC), a type of non-small cell lung cancer generally considered to be resistant to chemotherapy. Preliminary results were announced at the American Society for Clinical Oncology annual meeting. Investigators from Vanderbilt University Medical Center also contributed to the research, which was funded by Genentech Inc., South San Francisco, CA.
"While it is premature to make any conclusions about survival, we found that this treatment induced regressions that were often dramatic in patients with advanced BAC, and that the responses seem more durable and meaningful than what we have seen with chemotherapy," said the study’s lead investigator Vincent Miller, MD, medical oncologist at MSKCC. "The treatment was especially effective in those patients who had never smoked," he added. "This is not a panacea, but to see a therapy actually cause tumour regression in a meaningful percentage of patients with this disease is really unexpected and a pleasant surprise. The hope is to ultimately manage BAC like a chronic disease."
Erlotinib is a small molecule that works by blocking the activity of an enzyme called "epidermal growth factor receptor (EGFR) tyrosine kinase," which helps communicate information within the cancer cell. EGFR is found on the surface of many tumour cells and may be involved in the growth and virulence of those cells.
BAC has certain pathologic and clinical features that distinguish it from other lung cancers. Approximately 3 percent of all lung cancer patients have what are called pure BAC tumours, but overall about 20 percent of an estimated 135,000 non-small cell lung cancers diagnosed each year possess some BAC features. BAC tends not to metastase, but rather to spread within the lung causing symptoms such as shortness of breath and sputum production. Chemotherapy usually does not work as well for people with this type of lung cancer as it may in other types. BAC is increasing in incidence and it is more common in women and in individuals who never smoked. Patients in this study experienced modest side effects including rash and diarrhoea, most of which seem to attenuate over time.
Patients who have higher levels of acid reflux where gastric juices flow back into the oesophagus, are more likely to develop cancer. New research by Lin and colleagues at University of Medicine, New Jersey, showed that the acidity may induce DNA damage by activating an enzyme - topoisomecase II - which is crucial in DNA replication.
Lin also found the presence of topo II molecules in other cancerous tissue, for example, in breast cancers. Acid alone may not be enough to cause carcinogenesis though.
The Lancet oncology reports on an ongoing study from the University of Texas (Anderson Centre) which reviewed 12,000 case histories. They are finding that among smokers there is a 40 to 87 per cent increased risk running in families where one member has lung cancer, thus indicating some sort of genetic predisposition.