According to The National Center on Addiction and Substance Abuse (CASA) at Columbia University, over the last three years the number of websites selling controlled prescription drugs such as opioids, depressants and stimulants has increased. The findings were presented in a new White Paper, “You’ve Got Drugs!” IV: Prescription Drug Pushers on the Internet, in May 2007 by CASA and released that same month at the U.S. Senate Judiciary Committee hearing on “Rogue Online Pharmacies: The Growing Problem of Internet Drug Trafficking” [1].
Joseph A. Califano Jr., CASA Chairman and President, said before the Senate Judiciary Committee [2]:
“The explosion in the prescription of addictive opioids, depressants and stimulants has, for many children, made their parents’ medicine cabinet a greater threat than the illegal street drug dealer. But, perhaps the most wide-open substance supermarket in the world is the Internet, which has become a pharmaceutical candy store, its shelves stacked with an array of addictive prescription drugs offering a high to any kid with a credit card number at the click of a mouse.”
Joseph A. Califano Jr. served as Lyndon B. Johnson’s domestic affairs chief and Jimmy Carter’s secretary of Health, Education and Welfare, where he started the nation’s first national anti-smoking campaign in 1978, calling cigarette smoking “Public Health Enemy Number One.” In 1992, he founded The National Center on Addiction and Substance Abuse (CASA) at Columbia University, recognized today as the nation’s top think tank on substance abuse involving tobacco, alcohol and illegal, prescription and performance enhancing drugs. The nonprofit organization aims to inform Americans of the economic and social costs of substance abuse and its impact on their lives.
Prescription drugs and the internet
Between 1992 and 2002, prescriptions written for controlled drugs such as OxyContin, Vicodin, Valium, Xanax, Ritalin and Adderall increased 154% [3]. The increase in prescriptions is 12 times the rate of increase in the U.S. population and almost three times the rate of increase in prescriptions written for all other drugs. Abuse of those drugs has also increased, from 7.8 million in 1992 to 15.1 million in 2003 [1].
The CASA White Paper indicated that, from 2006 to 2007, there has been a:
- 70% increase in the number of websites advertising or selling controlled prescription drugs over the internet
- 135% increase in the number of websites advertising controlled prescription drugs
- 7% increase in websites offering to sell controlled prescription drugs
More than two-thirds (84%) of websites selling controlled prescription drugs do not require a prescription from the patient’s physician. Of those sites that do require a prescription, more than half (57%) allow it to be faxed, giving the patient significant opportunity to forge the physician’s signature or use the same prescription multiple times.
Depressants (benzodiazepines) such as Xanax and Valium are the most frequently offered, sold on 79% of the websites selling controlled prescription drugs. Opiods such as Vicodin and OxyContin follow, sold on 64% of the sites. There are no controls in place to prohibit the sale of these drugs to children.
Keep in mind that these findings are a sampling of controlled prescription drug availability and do not capture the total number of sites advertising or selling controlled prescription drugs online.
Children are especially at risk
From 1992 to 2003, the number of children that admitted to abusing a prescription drug increased by 212% [2]. Even more shocking, from 1992 to 2002 new abuse of prescription opioids such as Vicodin and OxyContin in children between the ages of 12 to 17 increased by a whopping 542%, more than four times the rate of increase among adults.
While Americans represent only 4% of the world’s population, they consume two-thirds of the world’s illegal drugs [2]. A recent study was published assessing the motives and diversion sources associated with the nonmedical use of prescription opioids [4]. The three most common motives were to: (1) relieve pain; (2) get high; and (3) experiment. The leading sources for obtaining prescription opioids were friends and parents.
Compared to teens who do not abuse controlled prescription drugs, those who do are twice as likely to use alcohol, five times more likely to use marijuana, 12 times more likely to use heroin, 15 times more likely to use Ecstasy and 21 times more likely to use cocaine [3].
Addressing the issue
The National Association of Boards of Pharmacy has attempted to address the issue of online access to controlled prescription drugs and provide some assurance to consumers of legitimate websites by establishing a process for online pharmacy certification. Verified Internet Pharmacy Practice Sites (VIPPS) identifies to the public those online pharmacy websites that are appropriately licensed, legitimately operated via the Internet and have successfully completed a rigorous criteria review and inspection.
A complete list of these sites can be found in the Pharmacy category of the Highlight HEALTH Web Directory.
For those interested, you can read the CASA White Paper, “You’ve Got Drugs!” IV: Prescription Drug Pushers on the Internet, here.
What do you think about the increase in websites advertising and selling controlled prescription drugs? Have you ever bought drugs online? Why or why not?
References
-
“You’ve Got Drugs!” IV: Prescription Drug Pushers on the Internet. The National Center on Addiction and Substance Abuse (CASA) at Columbia University. 2007 May.
-
Chairman’s Statements: Statement by Joseph A. Califano, Jr. CASA Chairman and President, before the Senate Committee on the Judiciary Hearing on Rogue Online Pharmacies: The Growing Problem of Internet Drug Trafficking. National Center on Addiction and Substance Abuse at Columbia University. 2007 May 16.
-
Under the counter: The diversion and abuse of controlled prescription drugs in the U.S. The National Center on Addiction and Substance Abuse (CASA) at Columbia University. 2005 July.
-
McCabe et al. Motives, diversion and routes of administration associated with nonmedical use of prescription opioids. Addict Behav. 2007 Mar;32(3):562-75. Epub 2006 Jul 13.
View abstract
I’ve been so busy the last few weeks I missed this altogether. Many thanks to Jenny, a Highlight HEALTH email subscriber, for bringing this to my attention.
A new U.S. Food and Drug Administration (FDA) docket was published on the FDA website last month. The draft guidance, when finalized, will represent the FDA’s current thinking on complementary and alternative medicine (CAM). Docket No. 2006D-0480: Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration [1] discusses when a CAM product is subject to the Federal Food, Drug, and Cosmetic Act (the Act) or the Public Health Service (PHS) Act.
Here’s the important part in the draft:
The draft guidance makes the following two fundamental points:
First, depending on the CAM therapy or practice, a product used in a CAM therapy or practice may be subject to regulation as a biological product, cosmetic, drug, device, or food (including food additives and dietary supplements) under the Act or the PHS Act.
Second, neither the Act nor the PHS Act exempts CAM products from regulation.
Now, I do believe there exists a number of problems with the “natural health” industry. Foremost in my mind are issues regarding supplement extraction and processing, quality, absorption and bioavailability - there are no mechanisms in place to address any of these issues and protect consumers. [Indeed, these are some of the many reasons I recommend scientific review and assessment of third-party research and independent clinical studies.] However, the FDA draft guidance wording is so vague with respect to the extent of regulatory reach, any product used in CAM therapy or practice may be regulated. From the draft:
… depending on the CAM therapy or practice, a product used in a CAM therapy or practice may be subject to regulation as a biological product, cosmetic, drug, device, or food (including food additives and dietary supplements) under the Act or the PHS Act. For example, the PHS Act defines “biological product”, and the Act defines (among other things):
- Cosmetic;
- Device;
- Dietary supplement;
- Drug, as well as “new drug” and “new animal drug”;
- Food; and
- Food additive.
According to the Act, “dietary supplements” include vitamins, minerals, herbs or other botanicals, amino acids, dietary substances for use to supplement the diet by increasing the total dietary intake, and a concentrate, metabolite, constituent, extract, or combination of any ingredient previously listed.
It gets better:
Second, neither the Act nor the PHS Act exempts CAM products from regulation. This means, for example, if a person decides to produce and sell raw vegetable juice for use in juice therapy to promote optimal health, that product is a food subject to the requirements for foods in the Act and FDA regulations, including the hazard analysis and critical control point (HACCP) system requirements for juices in 21 CFR part 120. If the juice therapy is intended for use as part of a disease treatment regimen instead of for the general wellness, the vegetable juice would also be subject to regulation as a drug under the Act.
Did you get that? The Act would allow the FDA to regulate raw vegetable juice if it were used as part of a disease treatment regimen.
Thankfully, the FDA has decided NOT to regulate mind-body medicine, such as relaxation, meditation or group support. No, really …
NCCAM describes mind-body medicine as focusing on “the interactions among the brain, mind, body, and behavior, and the powerful ways in which emotional, mental, social, spiritual, and behavioral factors can directly affect health” [13]. It states that mind-body medicine “typically focuses on intervention strategies that are thought to promote health, such as relaxation, hypnosis, visual imagery, meditation, yoga, biofeedback, tai chi, qi gong, cognitive-behavioral therapies, group support, autogenic training, and spirituality” [14].
In general, CAM practices in this domain would not be subject to our jurisdiction under the Act or the PHS Act.
Needless to say, the natural health community has been up in arms about this. The flexibility of regulation the draft guidance allows the FDA is unprecedented and dangerous. Surprisingly however, the Organic Consumers Association (OCA) published this statement:
… after painstaking review of the FDA guidance document we have determined that the document does not call for any NEW regulatory or enforcement action, but merely clarifies existing ways that the FDA classifies (or “thinks”) about different types of products used in alternative and complementary medicine. After some discussion with our colleagues in the natural health freedom movement, we have decided that this document is not of any real significance.
This is not to say that we are happy with the FDA. We are NOT. Due to political appointees from the pharmaceutical and agribusiness industries, they’ve been asleep at the wheel with GMO, synthetic food additive, and pharmaceutical safety testing. It is high time they subject these products to the same type of rigourous scrutiny they seem to have for natural health products. And should the FDA decide to further target natural, non-synthetic health products, we will hit back with all our might.
The OCA statement really confuses me, because the entire issue stems from how the FDA wants to “think” about CAM products. The language used in the draft guidance is so broad that it would allow the FDA to regulate any dietary supplement that has any beneficial effect as though it were a drug. The draft continues:
… unless it is generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.
Regina over at Weight of the Evidence summed it up nicely:
The document, if approved, specifically medicalizes complementary and alternative therapies, along with the products, supplements, devices and even foods often part of those therapies. By using “treatment” rather than “therapy”; “medical” rather than “modality”; the document terminology sets traditional and alternative approaches to well-being and health inside allopathic or conventional medicine in the United States and will regulate products currently protected by congressional legislation, in DSHEA (Dietary Supplement Health and Education Act of 1994).
The FDA is accepting public comments on the docket until April 30th. Be sure to include the docket Number 2006D-0480 and submit your comments here.
Recommended reading: Jon Barron.
For those of you interested, you can read the draft document in its entirety here.
References
-
Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration. U.S. Department of Health and Human Services, Food and Drug Administration. 2006 Dec.
- Health freedom action alert: FDA attempting to regulate supplements, herbs and juices as “drugs”. NewsTarget.com. 2007 Apr 11.
Share on Facebook
Add to Connotea
Stumble it
add to delicious
Loading ...
