AmyTuteurMD

AmyTuteurMD
Bio
Dr. Amy Tuteur is an obstetrician-gynecologist. She received her undergraduate degree from Harvard College and her medical degree from Boston University School of Medicine. Dr. Tuteur is a former clinical instructor at Harvard Medical School.

Editor’s Pick
FEBRUARY 18, 2009 9:00AM

Counterfeit viagra and the risk of death

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It sounds like a joke, but it’s not funny at all. The world, including the US, is being flooded with counterfeit Viagra and other erectile dysfunction medications; the consequences include serious injury or even death.

A report in this week’s issue of the New England Journal of Medicine highlights the dangers.

Between January 1 and May 26, 2008, a total of 150 nondiabeticpatients with severe hypoglycemia were admitted to the fivepublic hospitals in Singapore. All the patients except one weremen, and they ranged in age from 19 to 97 years (median, 51).Seven patients remained comatose as a result of prolonged neuroglycopenia,and four subsequently died.

Glyburide was detected in blood or urine samples obtained from127 of these patients (85%)…  Four preparationswere contaminated with glyburide ... These drugs included a counterfeitof Cialis and three herbal preparations for thepurported treatment of erectile dysfunction (Power 1 Walnut,Santi Bovine Penis Erecting Capsule, and Zhong Hua Niu Bian).All four products also contained sildenafil [Viagra] in amounts rangingfrom 0.5 to 110.0 mg per tablet…

In other words, medications represented as Cialis or Viagra containing herbal preparations (e.g. Santi Bovine Penis ErectingCapsule) did contain small amounts of the active ingredient, but they also contained glyburide, a powerful medication used to treat diabetes. Since none of the men were diabetic, they experienced a severe drop in blood sugar (hypoglycemia). Seven men sustained serious brain damage due to low blood sugar, of which four ultimately died. That’s quite a steep price to pay for a chance at “sexual enhancement.”

The problem is not confined to foreign countries. There is a thriving trade in counterfeit Viagra that extends across the world and into first world countries, including the United States. An editorial in the February 2009 issue of The Journal of Clinical Practice outlines the problem:

 The biggest market appears to be phosphodiesterase type 5 inhibitors (PDE5is) with between 4500 and 15,000 web sites offering Viagra, Levitra and Cialis at cut prices…

 Harmful ingredients found in counterfeit medicines include boric acid, leaded road paint, floor polish, shoe polish to get the sheen on the tablet, talcum powder, cement powder, chalk and brick dust, nickel and arsenic. Any active drug ingredient is usually minimal or simply wrong – one supply batch of fake Viagra was in fact amphetamine and not sildenafil.

 If that wasn’t bad enough, some counterfeit Viagra has been associated with terrorism.

In one scheme counterfeit Viagra was imported from China and Eastern Europe for distribution in America with the money going to Middle East terrorist groups – Americans buying Viagra on the internet and unknowingly jeopardising the lives of their serving men and women.

The Food and Drug Administration, which under the Bush administration has been shockingly derelict in regulating approved medications, is all over this problem. The FDA has created patient education materials warning of the dangers of counterfeit medications sold over the internet or imported from outside the US.

Legitimate online pharmacies have also been advising patients on ways to spot counterfeit erectile dysfunction medications. According to edrugstore.md:

Here are some signs to help you identify illegal "generic Viagra" [Cialis or Levitra:

·         The site sells "generic VIAGRA" or "generic sildenafil citrate" [there is no generic form available]

·         The site claims to sell a cheaper form of VIAGRA

·         The price is cheaper than VIAGRA, by as much as 70%

·         The site claims the drug is made to World Health Organization (WHO) standards, which may be a lie. The WHO does not review or approve any medication

·         The drug is sold as a pill, but looks different from VIAGRA's normal color, shape and imprinting

·         Delivery times may be extended (4 -21 days) due to product being shipped into the United States from a foreign country

·         Shipping is initiated using a foreign country postal service to minimize chances of detection and seizure when entering United States

 In a world where we are constantly barraged with internet and print offers for “cheap” Viagra or herbal preparations to enhance sexual performance, everyone needs to be aware that a substantial proportion of these offers are fake medication, some of which are dangerous and deadly. Santi Bovine Penis ErectingCapsule sounds entirely harmless, but in reality, it has the potential to kill.

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Viagra pisses me off. I don't understand why insurance companies cover it. Erectile Dysfunction does not kill anyone. It doesn't even make people sick. What's the deal with refusing the cover women's issues- like infertility treatments or birth control- but covering ED? It's sexist.

But I suppose that's beside the point. People should know not to use crazy herbal supplements you buy off of the internet. Shoe polish? That's scary.
hollycomesalive:

"What's the deal with refusing the cover women's issues- like infertility treatments or birth control- but covering ED? It's sexist."

I agree. I don't think there is any question about it. Birth control, in particular, improves health by reducing pregnancies (particularly unwanted ones), regulates menstrual cycles, decreases the risk of anemia, etc. Viagra is never medically necessary.
I agree with hollycomesalive - but I save my anger. What do you expect - men still run most of the world, and women still have financial responsibility for most of the babies.

I'm wondering why there is not a generic form of this drug? It's fairly expensive, correct?
sandra no longer miller:

"I'm wondering why there is not a generic form of this drug?"

Pharmaceutical companies have patents on drugs. A generic cannot be marketed until the patent expires, and that usually takes 20 years.
Wow I didn't know that US insurance covers viagra and not birth control, who thought that would be a good idea? In business terms it would cost them less to swap. The NHS in the UK has a policy of free birth control and also treats infertility in some circumstances, but again funds erectile dysfunction for all. I would think that there is of course a psychological aspect to ED as a medical problem, and perhaps a non-direct neccesity?
emily Richards:

"I would think that there is of course a psychological aspect to ED as a medical problem, and perhaps a non-direct neccesity?"

Yes, but birth control is certainly more important both medically and psychologically.
What I want to know is who you and Dr Dach think can affrord to pay for 80 million baby boomers to have $50,000 heart and hip operations every year?

$6,000 an hour for surgeons is not sustainable. Medical costs are choking this country.
jimgalt:

"$6,000 an hour for surgeons is not sustainable. Medical costs are choking this country."

I read your piece. I appreciate the thought behind it, but it is filled with inaccuracies. With regard to physicians, you've made several major mistakes.

1. Many physician incomes are dropping as healthcare prices continue to rise. That's because physician compensation is only a small part of healthcare costs.

2. The "cost" of surgery has nothing to do with the reimbursement for surgery. The insurance companies pay what they want to pay, not the "cost" that you see on your bill. Typically, they will pay a percentage of the "price," often less than 50%.

3. The "cost" of surgery is the artificially inflated hospital price. The physician bills the insurance company separately. For example, when I was practicing, the "cost" of a C-section ran to many thousands of dollars. On the other hand, the reimbursement of the obstetrician was approximately $900 for all nine months of obstetric care, INCLUDING the delivery.

If you are going to make the argument that physicians are over paid, you should at least bother to find out what they are actually paid.
Oh my gosh! Counterfeit viagra funds terrorism! I was thinking of buying some, but not if I'm funding those dang terrorists killing our troops. Thanks for the irrefutable anecdotal evidence. That was helpful.

I'm sorry, I shouldn't be so sarcastic. It's probably true. It isn't out of the realm of possibility for illegal Viagra sales to be funding terrorists in some miniscule way. The problem is, nothing is safe from that distinction. Even totally legal, domestic sales of things as mundane as pizza deliveries have been shown to sometimes fund terrorism.

True or not, what a useless bit of information to include in this editorial.

PS: If it's 71% cheaper than Viagra, that means it's safe.
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