Drug safety
lborkowski | August 17, 2012by Kim Krisberg
For years, Peter Rosenfeld was looking for an effective way to treat what doctors had diagnosed as severe and intractable migraines. He'd heard of medical marijuana, but thought it was a joke — that it was just a way for people to justify their marijuana use.
Then in 2000, the New Jersey resident enrolled in a California program studying the effects of medical marijuana. It was a blind study, so Rosenfeld didn't know whether he was one of the participants being given marijuana or not. It turns out he was. And it worked.
"Marijuana was the first effective treatment that I had…
lborkowski | April 9, 2012In the New York Times last week, Gardiner Harris reported on tensions between FDA and the White House over FDA decisions that White House officials fear will be politically problematic for President Obama. Harris reminds readers that "The Bush administration repeatedly stopped the agency from issuing rules to prevent contamination of eggs, produce and other foods ... Much of the agency's staff assumed that the Obama administration would restore the agency's independence."
This assumption of the Obama administration restoring agency independence wasn't unfounded -- less than two months after…
cmonforton | January 11, 2012Washington State becomes the first in the nation to adopt specific workplace safety rules to protect healthcare workers who are potentially exposed to anti-neoplastic drugs and other hazardous medications. The new rule, issued earlier this month by the State's Department of Labor & Industries, stems from legislation passed in April 2011 and signed into law by Governor Chris Gregoire. The rule applies to healthcare facilities in which employees are "reasonably anticipated" to have "occupational exposure to one or more hazardous drugs." The CDC's National Institute for Occupational…
lborkowski | September 17, 2010Earlier this week, FDA Commissioner Margaret Hamburg presented Frances Kelsey with the first in what will be a series of awards bearing Kelsey's name. Fifty years ago, as a new medical officer with the FDA, Kelsey refused to approve US sale of Kevadon, a drug widely recognized by its generic name, thalidomide. The drug was widely used as a sleep aid and anti-morning-sickness drug in Europe, but Kelsey questioned its safety.
While thousands of children were being born in Europe with missing limbs and other thalidomide-induced birth defects, the US avoided such widespread tragedy. In 1962,…
terrasig | May 6, 2010Let me just say at the outset that I generally pay extra to purchase brand name medications, prescription or over-the-counter (OTC), because of concerns I have about federal oversight of generic drug manufacturers.
However.
On April 30, McNeil Consumer Products issued a voluntary recall of a litany of children's cold products under the Tylenol, Motrin, Zyrtec and Benadryl brand names.
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-…
terrasig | November 25, 2009
By most metrics, those of us at Terra Sig World Headquarters are liberals. Nevertheless, we often enjoy reading conservative writer, attorney, and American Enterprise Institute fellow, David Frum. Perhaps I have a soft spot for him because he's Canadian and he also writes for my favorite print newsmagazine, The Week.
Well, Frum chose this week to write, "Herbal remedies need real scrutiny," at his FrumForum and the post was subsequently published as a special commentary at CNN.com. The latter version has accumulated about ten times as many comments. The thesis of his essay is that the…
terrasig | May 23, 2009
The US Food and Drug Administration is usually the first federal authority to take action on adverse event reports for any health product. But few appreciate that the FDA is also responsible for regulation of cosmetic products: pretty much anything applied to the skin.
So, it was no surprise when I was trolling the FDA adverse event reports and news releases to find their announcement of a recall of a number of children's face paints due to rashes and undue skin irritation. The products are manufactured by Shanghai Color Art Stationery Company Limited, Shanghai, China.
The original recall…
terrasig | January 13, 2009I just started receiving a bunch of Google referral hits from readers searching for a story about the US Federal Trade Commission apparently taking regulatory action against a church that is selling supplements claimed to exhibit anti-cancer activities.
The article in question, "Tyrannical FTC Threatens Christian Church with Imprisonment for Selling Dietary Supplements," was written by a gentleman named Mike Adams, an editor at NaturalNews.com. I'm not exactly certain at this point what the specific FTC actions are today since the article is rife with rantings and rhetoric:
The FTC has…
terrasig | December 30, 2008I see you - I've been there.
You're sitting in the lab the day before New Year's Eve looking at what you've done over the last year - or last six years - and thinking about how you're ever going to turn this postdoc or extended grad school period into some gainful career. The economy is for hell no matter where you live and you're wondering if this is all worth it.
Well, as I've said before, don't limit your options until you explore them. The US drug, medical device, food, cosmetic regulatory and safety agency, the Food and Drug Administration (FDA), can provide a really satisfying…
terrasig | June 25, 2008When I first heard that 24-year-old British singer-songwriter Amy Winehouse was hospitalized with early stage emphysema I said "what?" DrugMonkey, a drug-abuse research colleague, has a terrific post up now on the link between Winehouse's crack cocaine use, possible genetic predisposition, and the emergence of early-onset emphysema.
While sad to see a very young person so afflicted, I tend to be fascinated scientifically by these odd medical cases involving natural products - often drugs of abuse.
I'm also particularly impressed by Amy Winehouse's tremendous vocal talents and songwriting…
terrasig | June 18, 2008This link is just to quickly follow up on yesterday's post, "FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'." The US FDA has specifically listed those companies and individuals as well as their specific products that were cited in yesterday's action:125 Fake Cancer "Cures" Consumers Should Avoid
And for more information to share with your family, friends, patients, colleagues, etc:Beware of Online Cancer Fraud
This latter post is of great general value for the lay public to detect red flags for fraudulent cancer treatment or prevention products as well as some general…
terrasig | June 4, 2008This whole "cosmeceutical" thing probably shouldn't be in "Medicine & Health" but we did call your attention to today's news item back on 27 July 2007: Drug maker Allergan announced at a stock analyst's meeting this afternoon that it is filing a New Drug Application (NDA) for a cosmetic form of its anti-glaucoma drug bimatoprost (Lumigan®) as a result of it side effect in increasing the number and thickness of eyelashes.
Allergan (nyse: AGN) has completed its clinical trial program demonstrating that its patented formulation of bimatoprost, when applied directly to the base of the…
terrasig | April 14, 2008Apologies in advance for just this quick link, but the topic is very timely given our highly-read post last week suggesting the repeal/modification of DSHEA, the primary US legislation directing the weak oversight of the dietary supplement industry.
Herbal Science International, Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers [press release]. FDA has long regarded dietary supplements containing ephedra, a…
terrasig | April 12, 2008". . .you got marijuana in my lead."
Two great tastes that do not go great together (with apologies).
[Welcome Fark.com readers on 12 Oct 2008 - I comment on the recent story here and you can read our other posts on drugs of abuse here. Thanks for stopping by - APB]
A concise but fascinating medical detective story appears in the letters of this week's (10 Apr 2008) issue of the New England Journal of Medicine (free full text at the time of this posting.).
An astute group of physicians at Leipzig Hospital in Germany noted a local surge of young people presenting with classic symptoms of…
terrasig | April 10, 2008The Dietary Supplement Health and Education Act of 1994 (DSHEA) allows herbal and non-herbal supplements to be sold in the US without demonstration of effectiveness or safety. Despite recent improvements in Good Manufacturing Practices required of supplement manufacturers, these products still pose significant risks to the population simply because the hands of regulatory authorities are tied - products cannot be removed from the market until there is evidence for lack of safety, meaning that consumers must first be harmed before FDA is authorized to intervene.
After cautions a couple weeks…
terrasig | March 26, 2008No, it's not a song by Foreigner - these are the names of two products "promoted and sold over the Internet for the treatment of erectile dysfunction (ED) and for sexual enhancement."
In yet another instance of a trend that would be comical if not so serious, the US FDA has announced that "Blue Steel" and "Hero" supplements contain chemical relatives of sildenafil, the active constituent of the prescription medication Viagra.
"Because these products are labeled as 'all natural dietary supplements,' consumers may assume that they are harmless and pose no health risk," said Janet Woodcock, M.…
terrasig | March 24, 2008Last week we spent some time discussing the shortcomings of the generic vs. brand name drug debate, focusing on an example of non-bioequivalence between the antidepressant Wellbutrin XL and its generic competitors.
Three days later, I then received an e-mail from one John Procter about a movement to get Washington to move forward on the approval of lower-priced generic biotechnology drugs now that original branded products are facing patent expiration. One source indicates that a $20 billion market value of biological products will be coming off patent by 2015. The US FDA has been reluctant…
terrasig | March 20, 2008The safety and effectiveness of medicines and other health products is dependent upon their proper use, particularly the proper route of administration. There are reasons why products are labeled as "for topical use only" or "do not swallow" - two recent warnings from the US FDA illustrate these issues.
Allergic Reactions with Use/Misuse of Denture Cleansers
The FDA recently announced reports of one death and 72 other adverse reactions in individuals who ingested denture cleansers meant to be used in a container with one's dentures removed. A crucial oxidizing agent, salts of persulfate,…
terrasig | March 18, 2008This issue was brought up by my fellow blogger, Joseph at Corpus Callosum, following an article in yesterday's LA Times.
For those not familiar with the concept or countries other than the US where laws may differ, generic drugs are those with the same active chemical as the originally-approved "brand name" drug. The original drug manufacturer is the one that conducts all of the preclinical and clinical safety and efficacy testing, natural product isolation and/or chemical synthesis, formulation with inactive ingredients to assure dissolution and reproducible release of the drug, etc. In…
terrasig | March 8, 2008Just a hypothesis here.
A vibrant, 55-year-old Denver-area furniture executive, Lesile Fishbein, is possibly near death according to The Denver Post:
The bubbly Fishbein, one of the most recognizable faces in the metro area because of her television ads for her company, Kacey Fine Furniture, was admitted to Presbyterian/St. Luke's Hospital for emergency treatment on Tuesday. She had been given an injection for chronic back pain and suffered a serious reaction, the friends said. She was later placed on life-support, which was removed Friday evening. [emphasis mine]
The natural product and…