Back to baked potato? Or is it another "laboratory finding"?

At the beginning of June, 2002 many newspapers started to report almost daily about some disturbing Swedish findings that put a scare through part of the food industry. According to a report disclosed in April, 2002 by Margareta Törnqvist from the Environmental Chemistry Department of Stockholm University, an ordinary bag of potato chips may contain up to 500 times more acrylamide than the maximum concentration allowed by the WHO for drinking water. Based on experiments in which rats were fed fried food, Swedish researchers estimated that acrylamide could be responsible for several hundred of the 45 000 cancer cases reported in Sweden each year. They declined to identify a specific type of cancer that could be caused by acrylamide, saying that further study was needed. Lilianne Abramsson Zetterberg, a toxicologist with a Swedish government agency was quoted as saying: "Do not stop eating these foods, but beware of what you eat, eat more cooked food, more vegetables". Since then, the UK and Norwegian national food agencies have also published similar findings.

The scare gained momentum, and on 25 June, 2002 WHO food safety experts started three days of meetings in order to probe reports that potato chips, French fries and other carbohydrate-rich foods contain cancer-causing substances. Dr Jorgen Schlundt, coordinator for the WHO’s food safety program, told a news briefing: "This is potentially a very important area in relation to some of the things that cause cancer in food. Suspect foods emerging from the studies were those containing a lot of starch, which are treated at relatively high temperatures".

Acrylamide is used in some colorings and glues, as well as for water purification and to coat the inside of tunnels. Until recently acrylamide was clearly classified as a potent neurotoxin affecting both the central and peripheral nervous systems (for further information visit http://www.inchem.org/ documents/pims/chemical/pim652.htm). The magnitude of the toxic effect depends on the duration of exposure and the total dose. Only the acrylamide monomer is toxic. Acrylamide polymers are non-toxic. Chronic acrylamide exposure has been associated with increased incidence of mesothelioma and cancers of the central nervous system, thyroid gland, other endocrine glands, mammary glands and reproductive tracts in rats and with lung adenomas in mice. Epidemiologic studies of workers exposed to acrylamide have failed to demonstrate any relationship between exposure to acrylamide and either overall incidence of malignancy or incidence of specific cancers. According to one theory acrylamide enters the neuron at the neuromuscular junction by pinocytosis and then binds to tubulin sulfhydryl goups in the axon resulting in disassembly of microtubules and consequent disruption of retrograde transport. Oncologists will find this description quite familiar as, superficially at least, it ressembles that of some cytotoxic agents.

Now, to put this scare into proportion, who remembers the pancreatic cancer and coffee story? Not to mention cyclamates and bladder cancer?

Amgen, Genentech and City of Hope: is it about money or principles?

In April, 2002 the US Federal Appeals Court revived Genentech Inc.’s 1996 patent infringement lawsuit against rival Amgen Inc. The dispute revolves around the method Amgen uses to produce filgrastim (Neupogen®), which had US sales of $1.3 billion in 2001. Genentech accused Amgen of infringement on three patents covering a method of producing proteins in bacterial cells. The patents were based on discoveries made at City of Hope National Medical Center in the late 1970s.

The ruling came as Genentech was defending itself in a breach-of-contract lawsuit by City of Hope over the patents. The hospital, based in Duarte, California, claimed that Genentech owes it royalties on drugs made by third parties that licensed the patents from Genentech. The research by City of Hope that lead to the patents was funded by Genentech. The dispute centered on a 26-year-old contract between the hospital and Genentech that established a profitable collaboration. In 1976, Genentech agreed to fund work by City of Hope scientists Arthur D. Riggs and Keiichi Itakura. The company also agreed to pay the hospital royalties on products that resulted from the scientists’ work. City of Hope, in turn, agreed to give Genentech the patents on any of their discoveries. Riggs and Itakura discovered a method that made it possible to mass produce human proteins, such as insulin, to treat disease. Their invention—a method of producing proteins in bacterial cells—remains widely used. Genentech obtained patents on the discovery by Riggs and Itakura, and, since 1980, has 22 licensing deals with other drug companies. Genentech has paid the hospital more than $285 million in royalties, but City of Hope claims that this does not represent the full potential of the discovery. The royalty stream under the Riggs and Itakura patents ends in 2003, when the patents expire. Without the $16 million in royalties it received from the patents the hospital would have been in the red for the 2001 fiscal year. However, City of Hope previously denied that the lawsuit was financially motivated.

On 24 June, 2002 one learned that a county jury voted to award the City of Hope National Medical Center $200 million in punitive damages in the retrial of a contract-dispute lawsuit brought by the hospital against Genentech Inc. According to a report in the San Francisco Times the jury had already awarded $300.1 million to the hospital two weeks earlier, finding it had been cheated out of millions of dollars in royalties for research on experimental drugs, and that Genentech had acted with malice or fraud. Genentech, which obviously plans to appeal, said the damage awards will result in a second-quarter charge of approximately $500 million.

Medical meetings: a limit is needed, but Italian legislators have exaggerated

Who would dispute that some meetings sponsored by pharma are used as a product launch (which is their normal interest)? The problem is that one wonders if all the ‘extras’ that come with such launches are really justified. Is it acceptable that millions are spent sending physicians to the other side of the world, to luxurious hotels, with music shows and other entertainment, to listen to data that could be presented to them locally? Maybe, as such events allow physicians from many countries to meet, exchange opinions and learn from peer experience, it is acceptable. The lavishness of such events could, however, be reduced, but would this saving make a big difference to the budget? Unfortunately some of these events are disguised promotional events for a product, but fortunately are not accompanied by CME recognition. This latter point should help authorities who, in countries such as Italy, have recently moved to decrease the budget pharma is allowed to use when it helps physicians to attend such meetings. The problem in Italy is that the new law calls for an across the board reduction in funding of 50%, compared with the previous year, and does not discriminate between legitimate CME events, the main one of which in medical oncology is of course the ESMO congress, and disguised promotional events. One hopes that a revised law will be voted on soon, and that legislators in all countries will recognize that as physicians are supposed to pursue continued education, much of this is made possible thanks to the generous support of Pharma, whereas governments provide very little support at all.





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