Drug safety
terrasig | August 9, 2007A federal appeals court has denied the right of patients to the use of cancer drugs prior to their complete assessment of safety and efficacy. The case was filed against the US FDA in 2003 by the Abigail Alliance for Better Access to Developmental Drugs, who argued that patients have a constitutional right to any drug in clinical trials.
The 8-to-2 decision by the Court of Appeals for the District of Columbia Circuit came in a closely watched and emotional case that pitted desperate patients willing to try unproven, even risky, therapies against those arguing that drugs should be proved safe…
terrasig | July 25, 2007An article in the most recent issue of Annals of Pharmacotherapy concludes that the vast majority of known cases of herbal medicine interactions with drugs go unreported. Researchers at the University of Alberta, University of Toronto, and Health Canada surveyed 132 pharmacists. While 47% of pharmacists had identified an herb-drug interaction, only 2 (1.5%) reported their cases to Health Canada.
But, according to the study authors, "19% of pharmacists said they had reported adverse events from mixing prescription and non-prescription drugs."
Why do pharmacists feel that reporting herb-…
terrasig | July 21, 2007Orac has the complete story but the FDA has finally shut down sales of dichloroacetate by theDCAsite.com and buydca.com run by Jim Tassano and Heather Nordstrom.
Two agents (Chris and Steve) from the U.S. Food and Drug Administration's Office of Criminal Investigations, San Francisco, arrived unannounced at about 11:30 am, on July 17, 2007 at our pest control office in Sonora California. They walked in, like men on a mission, I am told, and said "I need to speak to James Tassano".
I wasn't at that office. Our manager Eric called and informed me that 2 men from the FDA had come to see me. I…
terrasig | May 29, 2007From today's New York Times,
The 62-year-old former commissioner [Zheng Xiaoyu] received the unusually harsh sentence amid growing concerns about the quality and safety of China's food and drug system following several scandals here involving tainted food and phony drugs.
China is now under mounting pressure to overhaul its food export controls after two Chinese companies were accused earlier this year of shipping contaminated pet food ingredients to the United States, resulting in one of the largest pet food recalls in American history.
The government is also investigating how diethylene…
terrasig | May 27, 2007After worries over the last few weeks of diethylene glycol being substituted for glycerin in cough syrup and toothpaste, I was happy to be reminded that we have a green source for glycerin. No need to risk using Chinese-sourced glycerin - glycerin (glycerol) is a by-product of biodiesel production.
But rather than sell it for pharmaceutical uses, researchers at the University of Missouri at Columbia are investigating the biodiesel by-product for use in cattle feed:
In a study that began this month, Monty Kerley, professor of ruminant nutrition in the College of Agriculture, Food and Natural…
terrasig | May 24, 2007I seem to have missed this NYT article over last weekend. Following from the continuing appearance of diethylene glycol in glycerin imported from China, yet another consumer product is found to be adulterated, again in Panama:
Diethylene glycol, a poisonous ingredient in some antifreeze, has been found in 6,000 tubes of toothpaste in Panama, and customs officials there said yesterday that the product appeared to have originated in China.
This just goes to show that any product containing glycerin, from cough syrup to toothpaste, runs the risk of containing the cheap substitute, diethylene…
terrasig | May 18, 2007Actually, sharks do get cancer but a 15-year-old book by William Lane led people to think otherwise, launching investigation of shark cartilage as a source of antiangiogenic, anticancer compounds. While there is one promising shark cartilage extract (Neovastat) in clinical trials for multiple myeloma, most oral preparations on health food store shelves aren't stabilized and characterized well-enough to guarantee stability of antiangiogenic compounds.
But it gets worse with this news today from FDA's MedWatch program that illustrates once again the safety problems of some dietary supplements…
terrasig | May 16, 2007Time is short today so here are two quick picks of blog posts well worth reading on topics related to our normal discussions:
Joseph at The Corpus Callosum discusses a paper and a news report on putting drug safety risks in objective perspective relative to other risk behaviors we encounter daily, like driving a car. Depending on one's aversion to risk, some drugs can be considered relatively safe or dangerous, but Joseph points out that one must also consider the benefits of drugs in these risk assessment. But safety is not absolute: all beneficial activities and behaviors carry some risk…
terrasig | May 9, 2007Between melamine and diethylene glycol, most of my attention this past week has been on unsafe food and drug additives in products imported into the US and other countries. Nicholas Zamiska has an article in today's Wall Street Journal detailing this widespread problem: China, India, and Mexico are the countries that lead the number of refusals of food product imports by the US FDA:
Formaldehyde, which has been linked to cancer, has legitimate uses in adhesives and embalming. But in Indonesia, Sutikno, a 35-year-old tofu maker in south Jakarta who goes by one name, uses it to keep the tofu…
terrasig | May 8, 2007As noted in my Sunday post on the New York Times article on diethylene glycol (DEG) contamination of glycerin used for cough syrup, the US FDA has warned pharmaceutical manufacturers, compounding pharmacies, and repackers to test glycerine stocks for the toxic glycol.
Frequent commenter, Joe, noted that the sad part of the DEG deaths was that testing glycerin purity was a relatively simple chemical analysis. Through their guidance document, FDA has made available a free PDF of a paper from the Journal of AOAC International describing a simple, at-site thin-layer chromatography method for…
terrasig | May 6, 2007I wrote back in December about poisoning deaths in Panama due to a cough syrup substitution with diethylene glycol, a cheap industrial solvent that is toxic to the kidneys and nervous system when ingested. This same solvent was the cause of over a hundred deaths in the US in 1937, leading to passage of the most signficant drug purity laws in US history.
In this morning's New York Times, Walt Bogdanich and Jake Hooker present a comprehensive analysis of the Panamanian poisoning cases, tracing the diethylene glycol to a Chinese glycerine factory run by a former tailor. The Times reporters…
terrasig | May 3, 2007The other day I noted news of the Texas compounding pharmacy mistake that led to three deaths when an injectable colchicine preparation was found to be ten times more concentrated than labeled. Several readers commented on the reasons for the mistake, but I may have found another.
The source illustrating my pet peeve is the pharmacy's own drug recall announcement posted this week on the FDA MedWatch site:
Recent deaths have been reported in connection with compounded Injectable Colchicine .5mg/ml, 4ml vials, lot number 20070122@26. As a result, ApothéCure is issuing an immediate drug recall…
terrasig | May 2, 2007While the blogosphere buzz is the potential anti-obesity therapy put forth by Ron Evans' group to turn on PPAR-delta, I was reminded of shortcomings in our nation's drug distribution system from the FDA Medwatch program. (I've written about this topic before here and here.).
The latest alert regards a mix-up of weight loss drugs:
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA informed consumers and healthcare professionals regarding the dangers associated with buying prescription drugs over the internet.
FDA received information showing that 24 apparently…
terrasig | April 29, 2007This sad story harkens back to my days as a pharmacy prof when students would argue for points on an incorrect pharmaceutical calculations exam by saying, "well, only the decimal point was off."
A pharmacy erroneously made a drug 10 times more potent than intended, which killed three people who received it at an Oregon clinic, the state medical examiner said Friday.
ApotheCure Inc., a drug compounding pharmacy company in Texas, said an employee made a weighing error in the creation of the drug colchicine.
Drug compounding pharmacies have often attracted controversy. While they fulfill the…
terrasig | April 23, 2007More Canadian press leads me to put up another post on dichloroacetate (DCA), the inhibitor of mitochondrial aerobic glycolysis that is being promoted as a freely-available cancer "cure." Like many compounds tested in animal models of human cancer, DCA treatment reduces the size of human lung tumors grown in rats, but is far from a cure. Any other similar drug would be just one of hundreds jockeying for investment by drug companies large and small and might not even be competitive enough for entry into clinical trials. However, DCA is a bulk chemical that is largely available freely and is…
terrasig | April 7, 2007From a news release by the University of California at Davis:
The new study, published in this month's issue of Environmental Health Perspectives - available online at www.ehponline.org - was prompted by the case of a 54-year-old woman who was seen at the UCD Occupational Medicine Clinic following a two-year history of worsening hair loss, fatigue and memory loss.
Seafood is our primary source of arsenic in the food supply and we all have detectable arsenic in our blood after a plate of oysters. But this case was particularly disturbing:
Over a period of several months, the woman's short-…
terrasig | April 4, 2007I noted a couple of days ago the voluntary withdrawal of a drug used to treat Parkinson's disease called pergolide (Permax). The reason for the withdrawal is that the drug has been linked to reports of valvular heart disease (VHD) and I promised further explanation. The story is a continuing episode in pharmacology and drug safety that has been developing since 2000 or so when the diet drug combination, Fen-Phen, was withdrawn for a similar reason.
But what do diet drugs have to do with a drug for Parkinson's disease?
These stories illustrate just how much we have to learn about the human…
terrasig | March 30, 2007You may have read that pergolide (Permax), a drug used to treat Parkinson's disease, has been withdrawn voluntarily from the US market due to its causal association with heart valve abnormalities. I hope to have time later to discuss why these heart problems occur and why other Parkinson's drugs that act by a similar mechanism of action are still safe.
But for Parkinson's patients, there is a very, very important point made in the FDA's press release:
Pergolide should not be stopped abruptly, because rapid discontinuation of all dopamine agonist therapies can be dangerous. Instead,…
terrasig | March 23, 2007For your Saturday morning reading pleasure, here are two articles following up on my dichloroacetate (DCA) and bogus internet pharmacy death posts this week. Each was recommended by my clandestine operative from the Great White North, PharmCanuck:
Canadian cancer society warns of untested drug
Heather Logan, the director of cancer control policy at the society who trained as a nurse, has worked with people fighting to prolong their lives. Logan said she sympathizes with those who are buying the drug and mixing it at home as a last resort, but stresses there are serious safety concerns.
"The…
terrasig | March 22, 2007It's been just over a month since we last discussed cases of misfilled internet prescriptions and misbehavior by a US drug wholesaling firm. Yesterday, Sandra Kiume at OmniBrain told us about the death of a woman in British Columbia from what sounds like another case of terribly misrepresented drugs purchased over the internet (a second story is here). As Sandra noted,
A "strong sleeping pill and sedative" which "has been linked to overdose deaths in other countries and is not legally available in Canada" [nobody says which one!] along with an "anti-anxiety" medication and acetaminophen…