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The Food and Drug Administration (FDA) on January 25, 2001, issued an urgent recall of 38 injectable drugs marketed by Phyne Pharmaceuticals of Scottsdale, Arizona. Another company, AMRAM Incorporated, of Rathdrum, Idaho, manufactured these products for Phyne, which was AMRAM’s sole customer.
Last December 14, AMRAM notified Phyne that it was recalling these products because they were manufactured under substandard conditions. The nationwide recall followed FDA’s inspections of both Phyne...
The Food and Drug Administration (FDA) on January 25, 2001, issued an urgent recall of 38 injectable drugs marketed by Phyne Pharmaceuticals of Scottsdale, Arizona. Another company, AMRAM Incorporated, of Rathdrum, Idaho, manufactured these products for Phyne, which was AMRAM’s sole customer.
Last December 14, AMRAM notified Phyne that it was recalling these products because they were manufactured under substandard conditions. The nationwide recall followed FDA’s inspections of both Phyne Pharmaceuticals and AMRAM Inc. During the inspections, the FDA found violations of Good Manufacturing Practices manufacturing guidelines for pharmaceuticals. These guidelines are intended to help ensure that drug products are safe and effective and, in the case of injectables, sterile.
The FDA urges that anyone possessing any of these products should contact and return them to Phyne Pharmaceuticals at 7950 East Red Field Rd., Scottsdale, AZ 85267, (800) 345-3391 or 480-998-4142, FAX (480) 443-4775. Some of the products are labeled with both companies’ names; however, some may bear one or the other company’s name as manufacturer or distributor with or without the other company being identified. All lot numbers and codes, strengths and sizes and expiration dates are included in the recall. A list of the recalled products appears at the end of this article.
Some of the drugs on the list have legitimate therapeutic uses, such as colchicine, a very old drug used to treat gout. However, judging from the nature of a majority of the others it is most likely that medical consumers would be exposed to risk from these substandard products in the offices of complementary-alternative-medicine practitioners. It appears from a conversation we had with the FDA that chiropractors are among Phyne’s largest customers.
A number of these “drugs” are quite interesting historically. Their use was discredited decades ago but they are now reappearing as “cutting-edge” complementary-alternative-medicine treatments. Descriptions of a few follow:
• Pangamic acid is the 1951 apricot-pit creation of E. T. Krebs, Jr. who called it vitamin B-15 and promoted it to increase tissue oxygen levels and for numerous other situations, none of which have been substantiated. In fact, there is no evidence that pangamic acid is a vitamin. Krebs, an apricot-pit guru, was also the inventor of the quack cancer cure laetrile from apricot pits.
• Procaine is a very old local anesthetic that originally went by the brand name NOVOCAINE. In 1956, Professor Anna Aslan and her colleagues at the Parhon Institute of Geriatrics, in Bucharest, Romania, claimed remarkable beneficial effects in a wide range of disorders, including reversing of the aging process, from the intramuscular injection of procaine (which they called “H3” and hyped in some countries, including the U.S., as Gerovital H3). The claims have not been supported by any scientifically valid evidence or subsequent trials carried out by other researchers.
• Extract from the adrenal glands of cattle, sheep and pigs is sold as adrenal cortex extract by Phyne Pharmaceuticals. The FDA directed the removal of all products containing adrenal cortex from the market in January 1978 because of the substantial risk of under-treatment of serious conditions, such as adrenal cortical insufficiency, burns, and low blood sugar, when adrenal cortex extract was used. Adrenal cortex extract brought Phyne to public attention in September 1996 when the FDA issued an alert on this dangerous and unapproved drug after reports that at least 54 people had contracted serious bacterial infections after receiving the Phyne product. Seventeen patients had to have abscesses drained surgically.
The Centers for Disease Control and Prevention (CDC) reported in August 1996 that 68 patients had received the adrenal cortex extract from a Denver doctor who was promoting the product for weight loss. Adrenal cortex extract is also promoted on the Internet for a wide variety of other conditions such as low energy levels, aging, chronic fatigue, and stress, to name a few. The CDC said that 47 of these patients developed abscesses in either the arm or the buttocks, depending on what site was used for the injection. They also reported that five persons the doctor injected with extract in Wyoming also developed abscesses. A second Denver doctor reported two similar cases.
We are not aware of any patients becoming infected from the Phyne products involved in the current recall. However, there were three patients injured in Philadelphia after receiving injections of colchicine. Injectable colchicine is given in a dose of 0.5 milligrams per milliliter, but the Phyne product was mistakenly produced in a concentration of 5 milligrams per milliliter, 10 times more concentrated than it should have been.
Phyne’s ethical culture and disregard for the public’s safety is revealed in their notification to the FDA on January 29, 2001 that the company is not recalling vials of injectable adrenal cortex extract. How can Phyne blatantly ignore the FDA’s recall or for that matter continue to sell a drug that was banned in 1978?
In a face-off with the FDA, it appears that the agency is unsure if they have regulatory authority over many Phyne products. Products such as adrenal cortex extract, thymus extract, and pangamic acid injection may fall under the dangerously pro-quackery Dietary Supplement Health and Education Act (DSHEA) of 1994 and be considered dietary supplements. If this is the case, for all practical purposes, these products are unregulated and the FDA can do nothing, leaving consumers totally on their own. For this the public has the United States Congress to thank.
There is added concern about the source of glandular cow parts used to make, for example, thymus extract and the adrenal cortex extract injectables in light of the possibility that cows used are from countries where bovine spongiform encephalopathy (BSE or “mad cow” disease) exists. We do not believe that the FDA has adequate resources or regulatory authority to ensure that dietary supplement producers are not importing and using BSE-infected cow parts.
BUYER BEWARE!
What You Can Do
If a complementary-alternative-medicine practitioner, including a chiropractor, recommends an injection, especially a dietary supplement injection, grab your money and run.
