From The Editor:
You can go on the Internet today and find web sites offering to sell you the made-in-India generic equivalent of HIV drugs that cost $1,600 in the United States for $275. These sites are very convincing, very persuasive. They tell you that your government has been bought out by the big drug companies, and why should you pay so much just to protect their patents? Don't worry, they say. The shipment will make it through U.S. Customs. If it doesn't, we'll ship it again.
Don't believe any of it. These web sites are illegal enterprises, run by criminals. When you order from them, you have no idea what you're getting. It could be HIV medicine. It could be a sugar pill. It could be poison. And if you get ripped off, who do you complain to? No one. You were breaking the law, too.
The article that starts on the next page is called "Buyer Beware!" It is one of the most important we've ever run in this magazine. Buy a fake Rolex on the Internet if you want to. But don't buy fake HIV medications. Your life is at stake.
Internet Scams Targeting People with HIV
A little more than a month ago, I got a call from a reader in Florida named "Jeff." He had just tested positive, but his HIV was already well advanced: his T-cell count was 200, right on the borderline of an AIDS diagnosis. His doctor prescribed Atripla. Jeff had made contact with his local AIDS Service Organization and had an appointment to meet with a case manager to get his Atripla through the AIDS Drug Assistance Program (ADAP).
But while Jeff was cruising the Internet, looking for information about HIV, he found another option. He came across a website called MatchingRX.com, which claimed to import made-in-India generic equivalents of a variety of drugs for a fraction of the price of the brand-name drug. Among the drugs they offered was a generic version of Atripla. The price was so low that Jeff could afford to pay it out of his pocket. And it would save him from having to go through the bureaucratic hassles of applying for assistance from ADAP. He called me to ask if I could vouch for the site.
I told him in no uncertain terms that I could not vouch for the site-and I told him not to order from them! After we finished our conversation, I started to wonder: is this the only site out there making this kind of offer? Or are Internet scam artists starting to target people with HIV?
It didn't take long to find out that there are lots of sites on-line targeting people with HIV. They offer unapproved, low-cost versions of every HIV drug ever made. They also offer unapproved HIV test kits.
Why should you not order from one of these sites? Because you have no idea what you're getting! It is illegal to sell drugs in the United States which have not been approved by the United States Food and Drug Administration (FDA). So every one of these sites is a criminal enterprise! You don't know that the drug you're getting was made in safe, clean conditions, if it contains the right dose or the right ingredients, or if it even contains any active ingredients at all! Many counterfeit drugs are simply made of gypsum, the stuff dry-wall is made from.
When you order Viagra on-line and it turns out to be fake, it's a disappointment. But when you order HIV drugs on-line and they turn out to be fake, you're risking your life. Don't do it!
I had the opportunity to interview Richard Klein, the HIV/AIDS Program Director for the FDA.
I started by telling him about the phone call I got from Jeff, and about the supposed generic equivalent of Atripla he was thinking about buying. On the Matching RX.com website it is called "Viraday," and it is supposedly made by Cipla.
"First of all," Klein told me, "There is a program in existence called PEPFAR, the President's Emergency Plan For AIDS Relief. PEPFAR will buy drugs made outside of the United States even if they violate U.S. patent laws-but it requires that they meet FDA safety and quality standards. So the FDA has created a pathway for approval of these drugs. They can apply for tentative approval, which means they meet our standards and can be purchased with PEPFAR funds for use in developing countries."
"Cipla is a pharmaceutical company in India that does make drugs that have tentative approval for use by PEPFAR," Klein continued. "But Cipla has not even applied for approval for a generic equivalent for Atripla. It's not impossible that they make such a thing. But if they do, why haven't they put in an application for it?"
"Atripla is a great achievement because it combines three proven HIV drugs into one. But it wasn't easy to do," Klein says. "To get Atripla approved in the United States, the companies had to prove that the single combination pill mimicked the effects of the three drugs taken separately. And it took them a few tries to get it right. People tend to think of drugs as simple-but they're not. Even for major multi-national drug companies, making Atripla was difficult. With this made-in-India version, how do you know you're really getting the product? What's in the product? How bioavailable is it? Did someone just slap the drugs together? Has it been tested at all? If you're not really closely supervised by a doctor, you're going to find out when you have a problem with PCP pneumonia or another opportunistic infection."
Klein brought up the other issue as well: "How do you know where MatchingRX.com is getting their drugs? How do you know what they're sending out? You don't have any idea what you're getting. You don't know if any regulatory agency is watching over the process."
"Atripla is the easiest drug regimen currently on the market," Klein notes. "If you develop resistance to it by switching to a fake or substandard substitute, then by definition your life is going to become more complicated."
The HIV Test Kit Trap
Google "HIV Test" and you'll soon see ads for HIV tests that work something like a home pregnancy test. You mix a few drops of blood with a reagent, and in 15 minutes you know whether you're positive or negative, all in the privacy of your home.
There's just one problem: the FDA has never approved such a kit for use in The United States! The only home test approved by the FDA is manufactured by Home Access Health Corporation. It consists of a home collection kit which you send to the company. After seven days you call the company, anonymously, and get your results. You do not conduct the actual test yourself at home-your blood sample is analyzed by a laboratory, and the process is approved by the FDA every step of the way.
Don't be fooled! One site I looked at featured a picture of the Home Access test with a big yellow "FDA Approved" sticker on the side. But the kit they were actually selling was not FDA approved. It was a scam.
Are there any legitimate on-line pharmacies?
Yes, there are. To avoid being scammed by counterfeit drugs, the FDA recommends that you purchase only from state-licensed pharmacies that are located in the United States, where FDA and state authorities can assure the quality of drug manufacturing, packaging, distribution and labeling. That way, you know your medicine is coming from a reputable source, and you can get help if you have any problems. If you buy over the Internet:
If you buy from a foreign pharmacy site, a site that offers to sell you foreign-made drugs, or a site that claims to re-import U.S.-made drugs from a foreign country, you're taking your life in your hands. You're literally playing Russian Roulette. You have no idea what you're getting, and no one to complain to if something goes terribly wrong.
"But I can't afford FDA-approved HIV medications."
No matter how little money you have, you can get the medical care and medicines you need to live a long, healthy life with HIV. Regrettably, that isn't true everywhere in the world. But, in the United States, assistance is available.
If you are concerned about paying for your drugs, contact your nearest AIDS Service Organization and ask to speak with a case manager or benefits counselor. There are programs available to help you, and a case manager or benefits counselor can put you in touch with the one that is right for you.
Or, call the Partnership for Prescription Assistance at 1-888-477-2669. They are a single point of contact for more than 475 public and private programs designed to help you get the drugs you need regardless of how little money you have.
Copyright 2015, Positive Health Publications, Inc.
This magazine is intended to enhance your relationship with your doctor - not replace it! Medical treatments and products should always be discussed with a licensed physician who has experience treating HIV and AIDS!