Piracy

ST Nov 13, 2007
Herbal sex pill alternatives pose hidden dangers

LOS ANGELES - MANY of the pills marketed as safe herbal alternatives to Viagra and other prescription sex medications pose a hidden danger: For men on common heart and blood-pressure drugs, popping one could lead to a stroke, or even death.

'All-natural' products with names like Stamina-RX and Vigor-25 promise an apothecary's delight of rare Asian ingredients, but many work because they contain unregulated versions of the very pharmaceuticals they are supposed to replace.

That dirty secret represents a special danger for the millions of men who take nitrates - drugs prescribed to lower blood pressure and regulate heart disease.

When mixed, nitrates and impotency pharmaceuticals can slow blood flow catastrophically, leading to a heart attack or stroke.

An investigation shows that spiked herbal impotency pills are emerging as a major public health concern that officials haven't figured out how to track, much less tame.

Emergency rooms and poison control hot lines are starting to log more incidents of the long-ignored phenomenon.

Sales of 'natural sexual enhancers' are booming - rising to nearly US$400 million (S$ 582 million) last year. And dangerous knockoffs abound.

At greatest risk are the estimated 5.5 million American men who take nitrates - generally older and more likely to need help with erectile dysfunction.

The all-natural message can be appealing to such men, warned by their doctors and ubiquitous TV commercials not to take Viagra, Cialis or Levitra.

James Neal-Kababick, director of Oregon-based Flora Research Laboratories, said about 90 per cent of the hundreds of samples he has analyzed contained forms of patented pharmaceuticals - some with doses more than twice that of prescription erectile dysfunction medicine.

Other testers report similar results, particularly among pills that promise immediate results.
An elderly man in a retirement community north of Los Angeles took an in-the-mail sample and landed in the hospital for four days.

Tim Fulmer, a lawyer representing Spontane-ES, said the pill did not contain any pharmaceutical and was not responsible for the stroke.

Mark B. Mycyk, a Chicago emergency room doctor who directs Northwestern University's clinical toxicology research program, said he is seeing increasing numbers of patients who unwittingly took prescription-strength doses of the alternatives, a trend he attributes to ease of purchase on the Internet and the desperation of vulnerable men.

He said he wouldn't be surprised if there'd been undetected deaths from bad herbal pills.
Some herbal labels warn off users with heart or blood-pressure problems if they have taken their medicine within six hours; some doctors say 24 hrs or more would be safer.

The AP often couldn't determine from records whether incidents reported to tracking systems of the federal Food and Drug Administration and state poison control centers involved mixing herbal alternatives with nitrates.

Some men in their 30s who went to emergency rooms after taking herbal sex pills were presumably otherwise healthy, but they showed the transitory side effects of the active ingredients in regulated impotency pharmaceuticals, such as difficulty seeing clearly or severe headaches, records show.

While public health officials don't know the extent of the problem, they agree that incidents are vastly underreported, with national tracking systems capturing perhaps as little as 1 percent of them. Victims may be embarrassed, and doctors rarely ask about supplements.

Since 2001, sales of supplements marketed as natural sexual enhancers have risen US$100 million to US$398 million last year, including herbal mixtures, according to estimates by Nutrition Business Journal.

Some legitimate herbal mixtures claim to work gradually over weeks; it's the herbals marketed for immediate trysts that often are the problem.

Tight budgets, weak regulations and other priorities limit the FDA's ability to police the products, often promoted via blasts of e-mail spam and fly-by-night websites.

Linda Silvers, who leads an FDA team that targets fraudulent health products sold online said, ' a website can look sophisticated and legitimate, but actually be an illegal operation.'

In many cases, the ingredients used to alter herbal pills come from Asia, particularly China, where the sexual enhancers are cooked up in labs at the beginning of a winding supply chain.
The FDA has placed pills by two manufacturers in China and one from Malaysia on an import watch list.

Spiked pills have turned up in Thailand, Taiwan, Canada, Australia, New Zealand, Hong Kong, Malaysia, the United Kingdom and the United States, according to testing done by Pfizer Inc., the New York-based pharmaceutical giant that developed Viagra.

The company said that 69 per cent of 3,400 supplements it purchased in China contained sildenafil citrate, the main ingredient in Viagra.

Pfizer didn't check for the patented ingredients of its rivals.

While herbal alternatives often contain exact copies of the patented drugs, some makers tweak the molecules to keep the effect of the original pharmaceutical while avoiding the scrutiny of the FDA and outside testing labs.

During the past year, the FDA has orchestrated eight recalls of 'herbal' pills that contained the ingredients found in Viagra, Cialis or Levitra, or their unregulated chemical cousins. -- AP
----------------------------------------------------------------------------------------------------------------------

A perfect example to illustrate why "herbal" remedies that are marketed as natural and safe can be the exact opposite of what they are suppose to be. How did the manufacturers of these remedies know that their products are safe? Did they run tests on them? Maybe Pfizer did so on their behalf.

To add insult to injury, the herbal sex pills were not even "natural". There were in fact pirated versions of the real thing.

Seems like the lines between alternative medicine, quackery and fraud is starting to blur. Oh, was there even a distinction between them in the first place?

The poison that Traditional Chinese Medicine can be

On the topic of TCM again, many people tend to assume that the herbs used in chinese medicine, of which many are plants, are safe. Many tend to associate natural products as safe and that man-made chemicals are always bad. Nothing can be further away from the truth. The only way to know if these herbs are safe is to test them. Some may think that since many others have taken these herbs previously, the safety of these herbs should be apparent. However, I would like to quote Dr Ng Eng Hen "The relationship is not so simple".

There are many reasons why toxicity associated with plants often escape, well, association with the plant. For example, the effects of toxicity may be cumulative and only show up after prolonged usage of the causative agent. Or the effects are delayed, resulting in clinical signs showing up after many months have passed. Or it can be that the timing of the exposure plays an important role. It could also be that the toxic agents originate from parasites infecting the plant in question, so the plant will be toxin free most of the time but not all the time. With all these factors coming into play, it is very difficult to link toxicity to the causative agent.

So what are some examples of poisonous plants and the effects they cause?

Nerium oleander

This plant here is deadly. Chewing on just one leave can kill you.

Acacia georgineae

This tree here is deadly too. It produces fluoroacetate which shuts down the metabolic pathways in your body (TCA cycle), killing you in the process.

Gastrolobium

This pretty looking plant produces fluroacetate too.

Lolium perenne

This plant alone is non-toxic. However when it is infected by the fungus Neotyphodium lolii, the fungus produces toxins like ergovaline (causes hyperthermia syndrome and gangrene of your limbs) or other toxins that cause diarrhoea in animals at least.

Veratrum californicum

This plants here is amazing. The classic example of how the timing of ingestion affects the outcome. If ingested by a pregnant sheep at day 14 of pregnancy, this is what you get

Cyclopia

Yes. Cyclops do exist. By extrapolating this onto humans, you might get this

Not that I'm trying to scare you. But the fact is that drugs used in "western" medicine are all tested for safety and efficacy. It is a legal requirement. TCM herbs on the other hand...... well let's just say I have not been able to find data on safety and efficacy for most of those herbs. Given the difficulty in associating the clinical signs of toxicity with the herbs, and the fact that alot of chinese herbs are not tested for safety let alone efficacy, I would say it's better to stick with your "western" doctor. At least "western" drugs have been tested rigorously on lab mice, rabbits and Guinea pigs as well as humans, so that we know how safe and efficacious they are. Furthermore, you can sue your doctor if he gave you a sugar pill instead of anti-neoplastic drugs (for treating cancer) to treat your cancer. As previously pointed out by Angrydr here and here, it's hard to sue a geomancer or a priest conducting exorcisms since fengshui and ghosts are not proven to exist you can't say that they are negligent. Cancer treatment with TCM is not supported by any research studies. So how would you know if your TCM practitioner gave you the "correct" treament? Let's leave the toxic herbs out of the equation first. Can you even sue your TCM practitioner for giving you a sugar pill in the first place? "Western" doctors will be in a legal fix if they did that.

Given the prevalance of poisonous herbs (no real suprise since plants evolve defence mehanisms to protect themselves), the diffculting in establishing a link with toxicity and causative agent and the lack of data on safety as well as efficacy it would be unwise to turn to TCM.

So why are there so many people who swear by TCM?

1) Dead patients can't tell you that TCM didn't work for them.

2) Group think (mutual influence in a group of people)

3) The placebo effect

4) Many diseases are self limiting, giving the illusion of a cure

5) Concurrent "western" medical treatment that was actually doing the good work, also giving the illusion of cure by TCM

ST forum letter promoting Quackery? Decide for yourself

Letter from ST forum

TCM centre at SGH a boon to cancer patients

THE news on '$2.8m TCM centre at SGH from Nov'' and 'Meeting of East and West in research'' (ST, Oct 20), moved me to tears.

The great moment - my hope for the day when our local public medical institutions/hospitals can support the use of both Chinese and Western medicine in the treatment of cancer is likely to come true.

As the founder of Cancerstory.com, a volunteers' initiative, I strongly feel that cancer patients should not be deprived of a chance to survive if medical science cannot help them.

In reality, there are some patients who are already 'sentenced to death' by their medical doctors but who have survived cancer after receiving some form of safe and reliable complementary treatment such as TCM.

TCM treatments have been shown to help relieve symptoms and improve the quality of life by lessening the side effects of conventional treatments and providing psychological and physical benefits to the patients.

Many cancer patients feel that no doctor will be pleased to learn of alternative life-saving antidotes that may threaten the 'supremacy' of Western medicine. When things go wrong, the doctors are also likely to put the blame on any form of complementary methods that their patients might be receiving alongside conventional treatment.

As a result, some patients decided to hide the fact that they were taking Chinese medicine even in instances when they were coping and progressing well during conventional treatment. Some doctors were amazed at the good results, but failed to discover the truth - that is, the efficacy of Chinese medicine.

However, I always encourage cancer patients to be truthful to their doctors. Lack of communication about TCM treatment and dietary supplements creates an information gap between doctors and patients that may result in poor cancer management.

Let's hope that the collaboration goes smoothly. To me, it will be the greatest gift to people living with cancer in the Remaking of Singapore - receiving true comprehensive cancer care and equal opportunities to fight cancer in their own stride.

If this happens, cancer patients no longer need to be concerned if TCM clashes with conventional treatment when treated by the 'East Meet West'' specialists in SGH.

Many cancer patients will no longer need to fork out hefty sums to consume expensive 'healing mushrooms'' such as lingzhi, yunzhi, maitake and agaricus.

A competent TCM practitioner/specialist is unlikely to treat cancer using an expensive single herb prescription.

Lee Soh Hong (Miss)
---------------------------------------------------------------------------------------------------

"In reality, there are some patients who are already 'sentenced to death' by their medical doctors but who have survived cancer after receiving some form of safe and reliable complementary treatment such as TCM. "

Erm...... claiming credit for the efficacy of real medical treatment for cancer? How did you know it was the TCM herbs that sent the cancer into remission and not real medical treatment that was doing the job?

"TCM treatments have been shown to help relieve symptoms and improve the quality of life by lessening the side effects of conventional treatments and providing psychological and physical benefits to the patients. "

That's a pretty big claim. But I wondered why you did not cite the research studies that suggests that TCM treatments can do all of those.

"Many cancer patients feel that no doctor will be pleased to learn of alternative life-saving antidotes that may threaten the 'supremacy' of Western medicine. When things go wrong, the doctors are also likely to put the blame on any form of complementary methods that their patients might be receiving alongside conventional treatment.
As a result, some patients decided to hide the fact that they were taking Chinese medicine even in instances when they were coping and progressing well during conventional treatment. Some doctors were amazed at the good results, but failed to discover the truth - that is, the efficacy of Chinese medicine. "

Doctors would be delighted if Chinese medicine were really efficacious for this would mean that the active ingredient in the herbs can be isolated, adding to the repertoire of anti-neoplastic drugs they have. The question is where is the evidence that demonstrate the efficacy of Chinese medicine?

This was what one study published by the Japanese Journal of Clinical Oncology said:
In conclusion, Chinese cancer patients, willingly, rampantly and non-selectively seek out and consume alternative medications, with almost total ignorance of the medication consumed, oblivious to any potential side effects, and with little subjective benefit.

Personally, I feel it is absolutely irresponsible of ST to publish such a letter that might skew the decision of a cancer patient towards using TCM rather than real medicine. All this letter is, is really an advertisement for TCM with misleading/dangerous/unsubstantiated claims. I mean where the hell are the studies that demonstrates the efficacy of TCM for cancer?