scinews0304003

scinews0304003
Iressa vendor failed to warn of side effects
The Yomiuri Shimbun

   AstraZeneca K.K., the Japanese vendor of the anticancer drug Gefitinib, marketed under the trade name Iressa, sold the drug to about 300 medical institutions without warning them about possible adverse side effects, in violation of national guidelines, sources close to the firm said Monday.
Government guidelines urge pharmaceutical companies to meet with medical institutions to explain any possible risks or side effects before shipping new medicines.
Side effects of the anticancer drug have reportedly led to 180 deaths.
Although it is not known whether the deaths are connected to the lack of consultation over possible side effects, the Health, Labor and Welfare Ministry plans to report the matter to its Pharmaceutical Affairs and Food Sanitation Council, which meets Friday, and discuss the company's handling of safety measures, the sources said.
The national guidelines stipulate that, when shipping newly developed drugs, pharmaceutical firms must send a representative to medical institutions to explain possible adverse side effects to doctors.
The ministry had demanded that the subsidiary firm of the London-based pharmaceutical company report on how closely it followed the guidelines, sources said.
According to the report compiled by AstraZeneca K.K., the company tried to comply with the guidelines by sending its employees to 1,539 institutions out of the 1,840 hospitals and clinics to which it shipped Iressa by Dec. 19, the sources said.
However, it failed to send employees to 299, or 16 percent, of its client institutions and gave no explanation at all to two institutions, the sources said.
In exceptional cases, in which a pharmaceutical company cannot set up a preliminary session with a medical institution before shipping drugs, the company is supposed to provide doctors with written information on the risks of side effects and visit the institution within two weeks, according to the national guidelines.
However, AstraZeneca K.K. failed to comply with the two-week rule with regard to 11 out of the 299 institutions, visiting the institutions more than two weeks after shipping Iressa, the sources said.

PHARMACEUTICALS
Sanko Junyaku Co., Eisai Co. and Fujirebio Inc. have concluded a joint research agreement for the development of an in vitro diagnostic test kit to determine DCP (des-carboxy-prothrombin, known as PIVKA-II in Japan), a marker of hepatocellular carcinoma. The test kit will be developed and used exclusively for Lumipulse, an automatic chemiluminescent enzyme immunoassay system developed by Fujirebio.
A test kit for PIVKA-II specially developed for Lumipulse will increase the convenience of detecting PIVKA-II in normal medical treatment practice. Also, the versatility of Lumipulse as a diagnostic instrument will be expanded by adding PIVKA-II as a new index. The test kit will be manufactured by Fujirebio and distributed by Sanko Junyaku, while both Eisai and Sanko Junyaku will cooperate over sales of the agent.

Takeda Chemical Industries, Ltd. has announced the discovery of a novel insulin secretion mechanism through free fatty acids that promote insulin secretion by activating a GPR40 receptor. Takeda initially confirmed that fatty acids act on GPR40 as ligands and GPR40 is abundantly expressed in pancreatic fA cells. Thereafter, functional analyses revealed that fatty acids activate GPR40 and promote glucose-stimulated insulin secretion from fA cells.
GPR40 was discovered as an orphan (without identified ligands) receptor in 1 997, and last year it was found in the pancreas, having fatty acids as ligands. (Compiled by The Daily Yomiuri)

U. S . panel urges approval for new antiwrinkle shot
By Lisa Richwine

GAITHERSBURG, Md.-A U.S. advisory panel urged regulators to approve the use of an injection of collagen and tiny plastic beads as a long-term fix for wrinkles.
   Artecoll, made by privately held Artes Medical, could provide competition to the Botox and collagen shots that are popular with Americans craving a younger look. Results from those injections last up to about six months. Artecoll, by contrast, is a permanent implant for ironing out wrinkles long-term its maker said.
   A study presented to a Food and Drug Administration advisory panel compared results from collagen and Artecoll six months after the injections.
   "The data is pretty convincing it's effective," said Michael Miller, a panel member and plastic surgeon from the University of Texas M.D. Anderson Cancer Center.
   On Friday, the panel voted 4-1 to recommend Artecoll's approval, giving the product a major boost toward the market, since the FDA usually follows its panels' advice.
   Panel members said it was important to make sure physicians were skilled in injecting the permanent material. They also said patients should be informed of potential risks, which can include lumps on the face. The panel also said it favored post-marketing studies of patients at least five years after patients received injections, and said the product should not be approved for lip augmentation.
   Artecoll contains tiny spheres of polymethyl-methacrylate, or PMMA for short, suspended in bovine collagen. PMMA is a polymer that has been used for more than 50 years in medical devices ranging from contact lenses to bone implants.
   The PMMA spheres, about the thickness of a human hair, settle in wrinkles as the bovine collagen gradually absorbs into the body, the maker said. Then, the spheres stimulate the body's own collagen to encapsulate them.
   A study found Artecoll patients had less severe lines between the nose and lips than collagen patients six months after treatment, as judged by researchers who reviewed patient photos. The study did not show a statistically meaningful difference between the two treatments in other areas of the face at the same time point, FDA reviewers said.
   For some patients in Europe, where the product has been available for years, Artecoll's effects have lasted up to 10 years, company officials said. FDA reviewer Binita Ashar said 16.3 percent of patients treated with Artecoll experienced an "adverse event," such as lumping or redness. Thirteen percent of collagen patients had adverse events. More Artecoll patients had lumpiness that persisted beyond six months, Ashar said.
   Artes Medical said lumps were treatable with cortisone shots. "I have never heard of any long-lasting disfigurement after Artecoll injections," said Gottfried Lemperle, Artecoll's inventor and the chief scientific officer for Artes Medical.
   But Diana Zuckerman, president of the National Center for Policy Research for Women and Families, said the FDA should require longer studies before approving Artecoll.
   "If this product is approved, tens of thousands of women-probably even more-will have this product permanently injected in their faces. And yet, we really have no idea what will happen to them after two or three or four or 10 years," she told the panel. Company officials said they expected a final decision from the FDA in the coming months. If approved, Artecoll would be sold in the United States under the brand name Artefill.
   Artes Medical is based in San Diego. Irvine, Calif.-based Allergan Inc. makes Botox, which smoothes wrinkles by paralyzing the muscles that cause facial lines. Inamed Corp. of Santa Barbara, Calif., sells collagen under the brand names Zyderm and Zyplast.