Zicam, Part II
I discussed Zicam yesterday, but my comments were probably just gloating over the FDA dealing with a unproven supplement in the same manner as it does with regular prescription and over-the-counter drugs. I want to go into some answers to questions I had in my own mind about this product.
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Homeopathic product recall
Today, the US FDA warned consumers to immediately stop using the product Zicam, a homeopathic remedy, because it may cause anosmia, the loss of sense of smell. The FDA has received over 130 adverse reports from consumers who believe that they suffered anosmia after using Zicam.
Zicam is marketed a Big Herba company, Matrixx Initiatives, Inc., and is sold as a remedy for relief of symptoms of colds, flu, and allergies (all with different causes). There is little or no evidence from respected peer reviewed journals that zinc gluconate, the active ingredient in Zicam, has any effect on the course, duration, or severity of common upper respiratory tract infections. The Cochrane Reviews state that, the “evidence of the effects of zinc lozenges for treating the common cold is inconclusive.” Infectious disease researchers from Stanford University have concluded that most positive studies of zinc gluconate are flawed in design and that the “therapeutic effectiveness of zinc lozenges has yet to be established.” A well designed double-blind study published in Clinical Infectious Diseases concludes that the “data do not support a role for intranasal zinc gluconate for prevention or treatment of the common cold.” Read More...
Zicam is marketed a Big Herba company, Matrixx Initiatives, Inc., and is sold as a remedy for relief of symptoms of colds, flu, and allergies (all with different causes). There is little or no evidence from respected peer reviewed journals that zinc gluconate, the active ingredient in Zicam, has any effect on the course, duration, or severity of common upper respiratory tract infections. The Cochrane Reviews state that, the “evidence of the effects of zinc lozenges for treating the common cold is inconclusive.” Infectious disease researchers from Stanford University have concluded that most positive studies of zinc gluconate are flawed in design and that the “therapeutic effectiveness of zinc lozenges has yet to be established.” A well designed double-blind study published in Clinical Infectious Diseases concludes that the “data do not support a role for intranasal zinc gluconate for prevention or treatment of the common cold.” Read More...
Increased FDA scrutiny of medical devices
May/07/09 07:51 Filed in: Medical devices | Medical products
In the early 1990’s, Congress directed the US Food and Drug Administration (FDA) to gather more rigorous evidence before a they give approval to manufacturer to market medical devices that were considered the most risky, a category known as Class III devices. The FDA never implemented the law, and several hundred Class III devices were approved by the FDA based on a less rigorous path using a 510(k), which allows the manufacturer to establish that their products are “substantially equivalent” to products marketed before 1976. Early this year, the Government Accounting Office (GAO) issued a report that stated these conclusions about the process:
The recommended that the FDA take immediate steps to issue regulations for all of the Class III devices that were allowed to enter the market through the 510(k) process. They directed the FDA to either reclassify each Class III device into either Class I or Class II (based on scientific evidence only) or require that it remain Class III. Those products that remain in Class III will require a new approval through the Pre-Market Approval (PMA) process, the most stringent for medical devices. Read More...
FDA has stated that eventually all class III devices will require FDA approval through the PMA process and FDA officials reported that the agency is committed to addressing this issue, but the agency has not specified time frames for doing so. Without FDA action, the remaining preamendment class III device types—including device types that FDA identified in 1994 as presenting an unreasonably high risk to public health—may enter the U.S. market through FDA’s less stringent premarket notification process.
The recommended that the FDA take immediate steps to issue regulations for all of the Class III devices that were allowed to enter the market through the 510(k) process. They directed the FDA to either reclassify each Class III device into either Class I or Class II (based on scientific evidence only) or require that it remain Class III. Those products that remain in Class III will require a new approval through the Pre-Market Approval (PMA) process, the most stringent for medical devices. Read More...
Politics and the FDA
Mar/26/09 10:50
With the election of Barack Obama, many believe that there would be a change in healthcare policy, reversing some of the policies of his predecessor. I had discussed some of the predicted changes several times recently. Additionally, with the appointment of a new FDA Commissioner, Margaret A. Hamburg, I was becoming confident that the FDA would become an advocate for consumers and industry, and that many of the more egregious political decisions that harmed the medical products industry would be overturned or modified. It is clear that the change would be take time because of the many priorities in the new Obama administration, but decisions such as the executive order clearing the way for research using embryonic stem cells are moving medicine and science in a healthy direction.
I personally object to political considerations taking priority for science and medicine. It’s a waste of money, it places undue burdens on both the medical products industry and the agencies that regulate them, and it increases the amount of time to get products onto the market. In addition, it allows foreign companies, whose regulatory agencies may not have these egregious political issues, to bring to market products that help their citizens. In some cases, foreign subsidiaries of US companies provide newer products to residents of those countries than they do for US residents. Read More...
I personally object to political considerations taking priority for science and medicine. It’s a waste of money, it places undue burdens on both the medical products industry and the agencies that regulate them, and it increases the amount of time to get products onto the market. In addition, it allows foreign companies, whose regulatory agencies may not have these egregious political issues, to bring to market products that help their citizens. In some cases, foreign subsidiaries of US companies provide newer products to residents of those countries than they do for US residents. Read More...
New FDA Commissioner
Mar/13/09 11:08
On March 11, President Obama appointed Margaret A. Hamburg, MD to be the new FDA Commissioner. She has a substantial educational background including an MD degree from Harvard and training in neuropharmacology. She has had long public service at the U.S. Office of Disease Prevention and Health Promotion, the National Institute of Allergy and Infectious Diseases at NIH, where her work focused on AIDS research, and Health Commissioner for New York City. President Clinton selected her in 1997 to be assistant secretary for policy and evaluation at the U.S. Department of Health and Human Services. Not only does she have a background in healthcare policy, medical research, and the bureaucracy that controls both, she has experience with industry, sitting on the Board of Directors of Henry Schein. Read More...