Local firm must stop selling Botox knockoff

A Florida judge wants to protect unsuspecting consumers from 'tragic consequences.'

The Associated Press and IRWIN M. GOLDBERG
Tucson Citizen

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Tucson-based Toxin Research International, its owners and other associated companies must stop selling a Botox knockoff, recall all the product that has been sold and turn leftover product over to the Food and Drug Administration, U.S. attorney spokesman Carlos B. Castillo said yesterday.
"They are supposed to work with the FDA to identify all purchasers of the product" so it can be recalled, he said.

The verbal order came after a daylong preliminary injunction hearing in Florida, Castillo said.

TRI sold 3,000 vials of the raw botulism toxin, according to The Associated Press. The product's maker, List Laboratories in California, is blamed for the paralysis of four people injected with the toxin at an Oakland Park, Fla., clinic.

Toxin Research employed misleading and deceptive practices that are "likely to result in tragic consequences to the unsuspecting consumer," U.S. District Judge James Cohn said at the end of the hearing, according to AP. The company and its operators "have exposed the public to a great health risk."

The judge granted the government's request for an injunction to shut down Toxin Research and its botulism sales.

The company pitched the toxin for sale to 15,000 dermatologists, plastic surgeons and other doctors nationally, including 110 Arizona doctors, 27 of whom were in Tucson, government evidence showed at a hearing yesterday.

Thirteen of the Tucson doctors or their representatives told the Citizen they had nothing to do with TRI or its associated companies, save for perhaps receiving an unsolicited mailing about purchasing its product.

The other 14 doctors or their offices did not return calls.

According to court documents filed to obtain an emergency restraining order, two Arizona medical professionals did buy TRI's Botox knockoff, marketed as Botulinum Toxin Type A: Dr. Ann Murray of Lake Havasu City and Richard Allen, a physician's assistant in Anthem.

Neither was on the list.

Murray, according to the documents, used the product on herself and patients but destroyed the remaining product after reading about the Florida incidents.

At yesterday's hearing, Chad Livdahl, a microbiologist who owns the company, testified repeatedly that his sales were intended for research only and not for human use in place of the wrinkle treatment Botox.

Robert Gehrke, Livdahl's attorney, said his client "was not aware that some customers were using it on human beings."

Assistant U.S. Attorney Russell Koonin countered, "Those are not researchers that Dr. Livdahl is soliciting. Those are private, in-house physicians."

He told the judge that Toxin Research compared Livdahl's unlicensed product to Botox in an end run around federal regulations.

Investigators found evidence that two other Livdahl companies, Powderz and Z Spa, were planning promotional seminars this month and in March for its products, according to the AP.

The companies and their operators are targets of a criminal investigation, but no charges have been filed, the AP reported.

Livdahl has not applied for FDA approval for a generic Botox, but he testified that he was building a laboratory to produce a low-dose botulism product.

Neither Livdahl or the agency has publicly accounted for more than 2,300 vials. Livdahl estimated about 530 were damaged by lack of refrigeration, the FDA seized 134 at the Tucson office, and 51 were sold in South Florida, according to the AP.

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ضرر مسکن ها برای دستگاه گوارش آشکار شد

براساس تحقيقات تازه خطر آسيب ديدن روده در اثر مصرف مسکن های رايج مانند ايبوبروفن و آسپيرين، احتمالا شديدتر از آن است که تاکنون تصور می شد.
پزشکان دريافتند بيش از 70 درصد بيمارانی که برای بيش از سه ماه مسکن های نوع "انسيد"
(non-steroidal anit-inflammatory drugs) مصرف می کنند، آثار زخم در روده کوچک آنها پديدار می شود.

قبلا تصور می شد که خطر اين داروها برای دستگاه گوارش بسيار کمتر است.

نتايج اين مطالعه، که توسط کالج پزشکی بيلور در شهر هيوستون آمريکا انجام شده است در نشريه "بيماری های دستگاه گوارش و هپاتولوژی" منتشر شد.

تيم محققان دانشگاه بيلور 21 بيمار را که مسکن های نوع "انسيد" مصرف می کردند با 20 بيمار که از انواع ديگر داروهای مسکن استفاده می کردند يا اصلا مسکن مصرف نمی کردند مقايسه کردند.

در حدودا 71 درصد از بيمارانی که "انسيد" مصرف می کردند، در روده کوچک آثار زخم هويدا شد در حالی که اين رقم برای ساير بيماران تنها 10 درصد بود.

دکتر ديويد گراهام، که در اين تحقيقات شرکت داشته است، می گويد: "هميشه می دانستيم که انسيدها می توانند باعث ناراحتی های بالقوه مرگبار در معده شوند، اما ابعاد تاثير آنها در روده کوچک تاکنون مجهول بود."

او افزود: "ما شاهد تعدادی زخم و مقدار زيادی فرسايش (در سطح روده) بوديم. هرکسی که برای يک سال آسپيرين يا ساير انسيدها را مصرف می کند با يک تا چهار درصد خطر ناراحتی های جدی دستگاه گوارش و روده روبروست."

با احتياط مصرف کنيد

دکتر الستر فوربز، متخصص بيماری های معده و روده در بيمارستان سن مارک در لندن و سخنگوی "بنياد اختلالات گوارشی" (Core) به بی بی سی گفت که احتمالا در اکثر کسانی که دستگاه گوارش آنها در اثر مصرف انسيدها صدمه ديده است هيچ گونه علائم جدی پديدار نمی شود.

وی گفت: "بايد همچنان نسبت به مصرف آنها محتاط باشيم و اين مطالعه به ما می گويد که نبايد آنها را مثل نقل و نبات تجويز کنيم يا مردم را به خريداری و مصرف آنها بدون مشورت با پزشک تشويق کنيم."

"اما در عين حال نبايد بيهوده وحشتزده شويم. کليه داروهای قوی دارای عوارض جانبی هستند، و گاهی فوايد آنها بر زيان هايشان می چربد."

دکتر مادلين ديوی، مدير پزشکی "تلاش برای پيشبرد تحقيقات آرتروز" گفت: "بسياری از بيماران می توانند درد آرتروز را در درازمدت با داروهای بسيار ايمن تر مانند پاراستامول (استامينوفن) - يا پاراستامول به علاوه کدئين - کنترل کنند."

"البته انسيدها جایگاه خود را دارند، اما بايد برای دوره های کوتاه و نه برای ساليان طولانی مصرف شوند."