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Jack Sisson's Life Ethics Blog

We must find new ways through many ethical issues, especially regarding bioethics, medical ethics, and criminal justice. Jack Sisson's 'Life Ethics' blog focuses on numerous areas of concern, including the philosophical and ethical dilemmas surrounding stem-cell research, abortion, medical research, and health care.

 

From Time:

“Rock Hard” and similar so-called “natural” supplements for men often contain potentially dangerous drugs — some of which have never been tested on animals, let alone humans.

In an editorial published in JAMA Internal Medicine, Pieter Cohen, assistant professor of medicine at Harvard Medical School and a colleague collected some of the lesser known facts about an industry that produces millions of pills — and likely generates tens of millions, if not billions of dollars in profits— but is almost entirely free of government oversight.

Here’s what they found:

*  A product sold as “Rock Hard for Men” in 2012 turned out to contain not only counterfeit Cialis (tadalafil)— but also a diabetes drug that can be deadly if used incorrectly.  A similar combination killed more than a dozen men in Asia in 2009.

*  One Utah company alone produced more than a million pharmaceutically-tainted pills monthly, earning $2 million between 2007 and 2010, according to an indictment issued in one of the few cases brought against such manufacturers.

*  More than three-quarters of male enhancement supplements tested in one study in Singapore contained pharmaceuticals that were not disclosed— and half of them were present in higher doses than recommended.

*  Over 45 different versions of drugs in the same class of Viagra have now been found in male sexual supplements.  A Dutch study found that 75% of the products sold in the Netherlands contained at least one analogue, or chemical variant that has the same effect as Viagra.

* A product called “Mojo Nights” recently analyzed by the Food and Drug Administration (FDA) included not just counterfeit Viagra, but also three different analogue drugs.

* Just last week, the FDA identified three tainted supplements: “Vicerex” and “Bullet Proof,” which contain counterfeit Cialis and “Lightning ROD,” which includes an analogue of Viagra.

“We’re talking about a massive number of brands and millions of millions of pills that are tainted,” Cohen says. “Hundreds of millions of pills are being produced every month that are spiked with these prescription medications — and worse, entirely novel drugs.” The presence of the new medications is particularly concerning since there are no data to support their safety, much less their efficacy. And they are sometimes sold alongside legitimate supplements and over-the-counter medications, so consumers often assume they are safe and tested.

The products are typically manufactured in China and sold either online or in health food or convenience stores.  The FDA and Drug Enforcement Agency (DEA) have repeatedly attempted to crack down on “legal highs” that contain analogues of chemicals such as the active ingredient in marijuana — sold as Spice or K2 — or other substances marketed as “bath salts” for recreational use. But these agencies have taken little action against male sexual enhancement manufacturers and those who illegally include active drugs in what are supposed to be “natural” herbal products.“The number of people prosecuted for this is probably less than half a dozen and the number of criminals involved is countless,” Cohen says.

“It’s so common that the FDA has been testing these pretty regularly and has set up a consumer information page,” says David Kroll, a pharmacologist at the North Carolina Museum of Natural Sciences, who was not associated with the study, but has studied pharmaceutical contamination of herbal products.

Cohen urges men to simply avoid these supplements; if they contain inert ingredients, then consumers would be saving their money, but if they contain unknown drugs, they could be dangerous to people’s health. “The bottom line is that any product being sold as a natural product for male sexual enhancement should be avoided. No legal natural ingredients work and we’re seeing lots of dangerous chemicals and novel medications.”

To create these new drugs, illegal manufacturers apparently search patent applications and studies for analogue compounds that may have a similar, desired effect to the legal medication and then synthesize and sell them. Many of these agents that appear in the scientific literature may never have been studied in animal research, which makes them particularly hazardous. Some compounds may even have been abandoned for safety reasons by drug companies. And while some clearly are effective in producing arousal or sexual enhancement, their side effects are unknown.

“It’s as if they are just playing mad scientist and coming up with new chemicals and now jumping from that to popping them at pharmacological doses into these supposedly natural supplements,” Cohen says.

Such backyard drug makers might even be encouraged by the lack of enforcement of laws prohibiting improper marketing of pharmaceutical-grade agents. It’s illegal to sell prescription medications and untested compounds as herbal drugs, for example, but few are prosecuted for it. “I think it’s an enforcement issue,” he says, “The regulatory authorities are spread too thin.” He says that there are other barriers as well: those who market the products can claim that they did not know the illegal ingredients were present. “[Some] companies that import [these products] say, ‘it’s adulterated when we get it.’ I don’t know what to do about that.”

To fight the illegal market, Cohen proposes making the legal drugs easier to get. “I would be for Viagra being over-the-counter,” he says, “It’s tremendously safe if you know what you’re taking,” and are given information about risks.  He recommends that for now, doctors be more generous in prescribing them, given that the risks of unknown drugs at unknown doses are far greater. If the legal drugs are simpler and less embarrassing to access, he argues, the market for the illegal versions will diminish.

Pfizer has already moved in this direction, announcing that it will sell Viagra online, with a prescription, so consumers can avoid the embarrassment of picking the drug up at a pharmacy.  The company told the New York Times the decision was part of its efforts to fight counterfeit drugs.

As with the “legal high” market, the globalization of drug manufacturing and the anonymity and ubiquity of the internet are fueling the traffic in male enhancement pills, and generating a market for the more questionable manufacturers. But Cohen hopes the study will raise awareness of the dangers of leaving the industry with little oversight, and compel health experts and legislators to enhance their own performance when it comes to ensuring medications are safe and effective.

Link to Time.

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