Drug & Device News

Is Drug Researcher Too Cozy With Manufacturers?

Responding to reports of possible conflicts of interest between a drug researcher at the National Cancer Institute and pharmaceutical companies, members of the House Energy and Commerce Committee in August reportedly sent a letter to the National Institutes of Health (NIH) asking for information about researchers' involvement with drug companies. (Willman, The Los Angeles Times, 8/10). There have been allegations that Thomas Walsh, the head of pediatric medical research at the National Cancer Institute, accepted consulting fees and/or research donations from drug manufacturers Merck and Fujisawa. He has also testified before government agencies on behalf of the two companies, something not generally allowed under federal law. The Congressional Committee has asked for several years' worth of Dr. Walsh's financial disclosure statements as well as documents setting out FDA policy on employees testifying on behalf of drug companies before the FDA and its advisory committees.

Human Tissue Processor Shut Down

Donor Referral Services, a human tissue recovery firm in Raleigh, NC, has been ordered to cease all operations and retain the tissues currently in inventory following FDA discovery that its manufacturing practices, including those governing donor screening and record-keeping, are deficient. The FDA also found that the firm was providing records to another human tissue recovery firm that identified different causes of donor death than were identified on the deceaseds' state-provided death certificates. The shutdown was ordered in accordance with FDA regulations that require tissue recovery firms to process all tissues in a manner to prevent the introduction, transmission, or spread of communicable disease. The agency's public notice confirms it has received no reports of adverse reactions in recipients of Donor Referral Services' products; still the possibility of adverse reactions cannot be ignored.

 

Device Identification System

The FDA is studying the advisability and feasibility of implementing a unique device identifier (UDI) program that would help track medical devices as they go from manufacturer to patient. The system would work like the bar codes currently used on drug and biological products. Says Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health, 'A unique device identifier system could have broad applications in reducing medical errors, facilitating device recalls, improving medical device adverse event reporting and encouraging cost effectiveness by improving delivery and supply chain efficiency.'

The agency is seeking public comment concerning the feasibility, utility, benefits and costs associated with developing and implementing a UDI system for medical devices. In addition, it wants to hear about various automatic identification technologies, such as bar code and radiofrequency, which could be used with a UDI system. To submit electronic comments, visit www.fda.gov/dockets/ecomments. Comments must include the docket number, 2006N-0292, and must be received by Nov. 9.

Ephedra Ban Was Within FDA's Authority

Federal regulators acted within their statutory authority in banning sales of ephedrine-alkaloid dietary supplements, including those found in ephedra, the Tenth Circuit U.S. Court of Appeals held on Aug. 17. Nutraceutical Corp. v. Von Eschenbach, 459 F.3d 1033, C.A. 10 (Utah 8/17/06).

The FDA banned the products, said to promote weight loss and boost
athletic performance, in 2004 after 7 years of scientific review linked them to increased risk of heart attack, stroke and death. Nutraceutical Corp. sued the federal government in U.S. District Court in Utah, where the judge ruled that the agency's risk-benefit analysis was contrary to the intent of Congress and had failed to prove by a preponderance of the evidence that the dietary supplements posed an unreasonable risk of illness or injury at small doses. The judge granted summary judgment for Nutraceutical and enjoined enforcement of the ban.

The Tenth Circuit reversed, saying that the agency's cost-benefit analysis did not improperly shift the burden to require Nutraceutical to prove that its product was safe, but rather found ample evidence that there is no safe dosage level.

 

Another Theory on Autism

Although many parents of autistic children blame thimerisol-containing vaccines for their children's development of autism, other theories abound. To add to these hypotheses, a new study published in the September issue of the Archives of General Psychiatry contends that the offspring of older fathers appear to be more likely to develop autism, pointing to a hereditary cause of the disorder. The study's authors cautioned that further study will be required before a definitive association between paternal age and autism can be made.

The study's researchers looked at the records of 130,000 Israelis born in the 1980s who were being assessed at age 17 for fitness to serve in the military. The potential military inductees fathered by men over the age of 40 were 5.75 times more likely to develop autism than were those whose fathers were younger than 30. The study's authors surmise that age-related mutations or changes in genetic imprinting may be at fault. The mothers' ages at the time the individuals were born showed little correlation between older mothers and an increase in the number of autistic children.

 

Government Agency Wins Against 'Alternative Therapy' Product Maker

The Federal Trade Commission (FTC) has prevailed in its case against QT Inc., the maker of the Q-Ray ionized bracelet, which the company claimed in televised commercials could reduce or eliminate pain in wearers. FTC v. QT Inc., No. 03-C-3578 (N.D. Ill. 9/8/06).

Defendant manufacturer claimed that even if the bracelet had only a placebo effect, its claims that wearers would feel better after using the product were not false. Said QT attorney Michael Ficaro of Chicago's Ungaretti & Harris before the judges ruling, the company was 'selling something that four out of five people say works. And if it doesn't, you get your money back ' How is that false advertising?'

The company was ordered to disgorge all profits from the sale of the bracelets and give refunds to consumers who bought the bracelets between 2000 and 2003. The court also issued an injunction prohibiting QT from engaging in further deceptive practices concerning ionized bracelets or any similar product.

 

Bausch & Lomb Product

The mystery continues in the case of the increased incidence of Fusarium keratitis among soft contact lens wearers who used Bausch & Lomb's lens solution ReNu With MoistureLoc before it was pulled from the market earlier this year. A study published in the August 23/30 issue of the Journal of the American Medical Association (JAMA) concludes that while the Bausch & Lomb product can be positively associated with contraction of the fungal eye infection, the exact source of that fungus remains unclear. No contamination could be found in the factory or warehouse, and no unopened solution bottles were found that contained the fungus. In addition, the products that were the source of infections were not produced contemporaneously with one another, and at least 10 different Fusarium species were identified.

Is Drug Researcher Too Cozy With Manufacturers?

Responding to reports of possible conflicts of interest between a drug researcher at the National Cancer Institute and pharmaceutical companies, members of the House Energy and Commerce Committee in August reportedly sent a letter to the National Institutes of Health (NIH) asking for information about researchers' involvement with drug companies. (Willman, The Los Angeles Times, 8/10). There have been allegations that Thomas Walsh, the head of pediatric medical research at the National Cancer Institute, accepted consulting fees and/or research donations from drug manufacturers Merck and Fujisawa. He has also testified before government agencies on behalf of the two companies, something not generally allowed under federal law. The Congressional Committee has asked for several years' worth of Dr. Walsh's financial disclosure statements as well as documents setting out FDA policy on employees testifying on behalf of drug companies before the FDA and its advisory committees.

Human Tissue Processor Shut Down

Donor Referral Services, a human tissue recovery firm in Raleigh, NC, has been ordered to cease all operations and retain the tissues currently in inventory following FDA discovery that its manufacturing practices, including those governing donor screening and record-keeping, are deficient. The FDA also found that the firm was providing records to another human tissue recovery firm that identified different causes of donor death than were identified on the deceaseds' state-provided death certificates. The shutdown was ordered in accordance with FDA regulations that require tissue recovery firms to process all tissues in a manner to prevent the introduction, transmission, or spread of communicable disease. The agency's public notice confirms it has received no reports of adverse reactions in recipients of Donor Referral Services' products; still the possibility of adverse reactions cannot be ignored.

 

Device Identification System

The FDA is studying the advisability and feasibility of implementing a unique device identifier (UDI) program that would help track medical devices as they go from manufacturer to patient. The system would work like the bar codes currently used on drug and biological products. Says Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health, 'A unique device identifier system could have broad applications in reducing medical errors, facilitating device recalls, improving medical device adverse event reporting and encouraging cost effectiveness by improving delivery and supply chain efficiency.'

The agency is seeking public comment concerning the feasibility, utility, benefits and costs associated with developing and implementing a UDI system for medical devices. In addition, it wants to hear about various automatic identification technologies, such as bar code and radiofrequency, which could be used with a UDI system. To submit electronic comments, visit www.fda.gov/dockets/ecomments. Comments must include the docket number, 2006N-0292, and must be received by Nov. 9.

Ephedra Ban Was Within FDA's Authority

Federal regulators acted within their statutory authority in banning sales of ephedrine-alkaloid dietary supplements, including those found in ephedra, the Tenth Circuit U.S. Court of Appeals held on Aug. 17. Nutraceutical Corp. v. Von Eschenbach , 459 F.3d 1033, C.A. 10 (Utah 8/17/06).

The FDA banned the products, said to promote weight loss and boost
athletic performance, in 2004 after 7 years of scientific review linked them to increased risk of heart attack, stroke and death. Nutraceutical Corp. sued the federal government in U.S. District Court in Utah, where the judge ruled that the agency's risk-benefit analysis was contrary to the intent of Congress and had failed to prove by a preponderance of the evidence that the dietary supplements posed an unreasonable risk of illness or injury at small doses. The judge granted summary judgment for Nutraceutical and enjoined enforcement of the ban.

The Tenth Circuit reversed, saying that the agency's cost-benefit analysis did not improperly shift the burden to require Nutraceutical to prove that its product was safe, but rather found ample evidence that there is no safe dosage level.

 

Another Theory on Autism

Although many parents of autistic children blame thimerisol-containing vaccines for their children's development of autism, other theories abound. To add to these hypotheses, a new study published in the September issue of the Archives of General Psychiatry contends that the offspring of older fathers appear to be more likely to develop autism, pointing to a hereditary cause of the disorder. The study's authors cautioned that further study will be required before a definitive association between paternal age and autism can be made.

The study's researchers looked at the records of 130,000 Israelis born in the 1980s who were being assessed at age 17 for fitness to serve in the military. The potential military inductees fathered by men over the age of 40 were 5.75 times more likely to develop autism than were those whose fathers were younger than 30. The study's authors surmise that age-related mutations or changes in genetic imprinting may be at fault. The mothers' ages at the time the individuals were born showed little correlation between older mothers and an increase in the number of autistic children.

 

Government Agency Wins Against 'Alternative Therapy' Product Maker

The Federal Trade Commission (FTC) has prevailed in its case against QT Inc., the maker of the Q-Ray ionized bracelet, which the company claimed in televised commercials could reduce or eliminate pain in wearers. FTC v. QT Inc., No. 03-C-3578 (N.D. Ill. 9/8/06).

Defendant manufacturer claimed that even if the bracelet had only a placebo effect, its claims that wearers would feel better after using the product were not false. Said QT attorney Michael Ficaro of Chicago's Ungaretti & Harris before the judges ruling, the company was 'selling something that four out of five people say works. And if it doesn't, you get your money back ' How is that false advertising?'

The company was ordered to disgorge all profits from the sale of the bracelets and give refunds to consumers who bought the bracelets between 2000 and 2003. The court also issued an injunction prohibiting QT from engaging in further deceptive practices concerning ionized bracelets or any similar product.

 

Bausch & Lomb Product

The mystery continues in the case of the increased incidence of Fusarium keratitis among soft contact lens wearers who used Bausch & Lomb's lens solution ReNu With MoistureLoc before it was pulled from the market earlier this year. A study published in the August 23/30 issue of the Journal of the American Medical Association (JAMA) concludes that while the Bausch & Lomb product can be positively associated with contraction of the fungal eye infection, the exact source of that fungus remains unclear. No contamination could be found in the factory or warehouse, and no unopened solution bottles were found that contained the fungus. In addition, the products that were the source of infections were not produced contemporaneously with one another, and at least 10 different Fusarium species were identified.