Many of us turn to the Internet to simplify our day-to-day transactions, reserving plane tickets, finding apartments and keeping in touch with old friends via cyberspace. Some of us even buy products such as prescription drugs online. This is one online transaction, says Dr. Marv Shepherd, which requires caution.

Before you click the mouse to have that antibiotic, asthma inhaler or cholesterol-lowering drug sent to your door, consider the risks, says Shepherd, the Klinck Centennial Professor in the College of Pharmacy and director of the Center for Pharmoeconomic Studies at The University of Texas at Austin. That Web site may make your prescription drugs more convenient, but it may also make them more dangerous.

Marv Shepherd

Dr. Marv Shepherd’s research and expertise on drug importation and drug counterfeiting has been featured on CNN, NPR and in Newsweek, Time, U.S. News & World Report, the New York Times, Washington Post and USA Today, among others.

“There’s a big problem with rogue Web sites,” Shepherd warns. “It’s very difficult to determine whether a Web site represents an authentic pharmacy or a counterfeit drug pharmacy. You can’t tell the good guys from the bad guys.”

Shepherd has made it his mission to keep the bad guys from getting their products into the homes and bodies of American consumers.

Rogue Web sites abound. Shepherd reports that the Food and Drug Administration (FDA) surveyed Canadian pharmacy Web sites. They discovered 11,000 Web sites claiming to be Canadian sites selling pharmaceuticals. Closer analysis revealed that only 214 pharmacies in Canada sell pharmaceuticals over the Web.

And what about the other 10,000-plus sites? They included sites in Pakistan, Southeast Asia, Mexico and even Washington State. Consumers who order pharmaceuticals from them may receive counterfeit drugs with incorrect dosage, false labeling, no pharmaceutical benefit or worse.

“For many counterfeit products, it is difficult to distinguish the genuine product from the counterfeit product without a forensic test,” Shepherd says. “They may have the brand name on them, but they aren’t the brand name product.”

When he began teaching at the university 25 years ago, Shepherd didn’t know he’d end up devoting his career to prescription drug safety. The need for more work in the area came to his attention in the early 1990s, when the former Green Beret found himself conducting studies on the U.S.-Mexico border on pharmaceuticals coming into the country from the south.

His concern was that people didn’t know enough about the drugs they brought in from Mexico, given that Spanish-language labeling and variations in dosage could cause problems for individuals. Because the drugs were sold over the counter, no licensed pharmacist was overseeing their sale.

Shepherd spent a few months at the border crossing at Laredo, surveying customs declaration forms and talking to people who went across the border to buy pharmaceuticals. He discovered that the number one drug coming across the border was Valium, and that the top 15 drugs coming across were all narcotic or psychotropic drugs.

“This sent a message,” Shepherd says. “We also noticed that it wasn’t elderly people going across the border; it was primarily people in their 20s and 30s. And the number two drug coming in was Rohypnol.”

Counterfeit and genuine pharmaceutical products placed side by side

For many counterfeit products, including pills, it is difficult to distinguish the genuine product from the counterfeit product without a forensic test, says Dr. Marv Shepherd of the College of Pharmacy.

Which one is the counterfeit Lipitor® above? The fake drug is on the left, and the authentic drug is on the right. Source: Pfizer Inc.

Rohypnol is commonly known as the “date rape drug.” Created as adjunct therapy with anesthetics for surgery and used in some countries for severe sleep disorders, Rohypnol erases memory. A fast-acting sleeping pill that’s undetectable when slipped into a drink, the drug was being used to aid sexual assaults on unsuspecting women.

Shepherd reported the incidence of Rohypnol importation to the U.S. Treasury Department, then in charge of U.S. Customs Service. His documentation was key to the 1996 ban on the drug by the Customs Service.

Since then, Shepherd has become a crusader on issues of drug safety, with his expertise cited in publications from the Wall Street Journal to Time magazine. Thousands of people show up to hear him speak about drug importation and drug counterfeiting.

American consumers buying from American pharmacies don’t have much to worry about, Shepherd says.

“I would have to say that the United States is one of the safest systems out there,” he says. “It’s what I refer to as a closed system. Everyone’s got to be licensed, and they’re talking about putting electronic tags on drug products that will track them through each point in the production process. You can’t say the same thing about buying off the Internet.”

The Internet can open consumers up to the potential of purchasing counterfeit drugs, which are a huge problem worldwide. While some counterfeit drugs may not harm those who take them, sometimes their impact can be devastating.

Some studies show that 20 percent of malaria deaths could be prevented if people were taking authentic anti-malarial medications and not fake ones. One million people die from malaria each year.

There’s also the recent case of cough medicine deaths in Panama, where a Chinese company not licensed to sell medicine sold diethylene glycol, a cousin of antifreeze, passing it off as glycerin. The product ended up in cough syrups, antihistamines and other products in Panama, and has been confirmed responsible for nearly 100 deaths.

Is Your Online Pharmacy an Authentic Pharmacy?

Dr. Marv Shepherd says there are a few ways you can check to be sure. Every state maintains a state board of pharmacy, easily accessible on the Web. They can confirm if a pharmacy is licensed in the state. Check the National Association of Boards of Pharmacy (NABP) for links to your state board.

In addition, you can look for the Verified Internet Pharmacy Practice Sites seal on the site. By clicking on the seal, a visitor is linked to a site where information about the pharmacy is maintained by the NABP.

If problems with drug counterfeiting seem especially dire right now, Shepherd says they’re actually not new.

“Counterfeiting has been around for centuries,” he says. “They were selling counterfeit products to the colonists from England and France.”

Without question, the potential for counterfeits getting to U.S. consumers has grown as pharmaceutical prices have increased, causing people to look for alternative sources. Shepherd agrees that pharmaceuticals have become prohibitively expensive and believes that it’s going to become imperative to find ways of ratcheting prices down. It’s a complicated task, however.

“The average product on the market right now cost about $800 million in research,” Shepherd says. “And it takes an average of 14 years to get a product to market.

“Seniors are always asking me why drugs cost so much, and I tell them you’re not only paying for that one drug. You’re paying for all the failures that happen in research. Drug research is expensive.”

The situation is further complicated by the way drugs are distributed, according to Shepherd. Canada and countries in Western Europe mandate price controls on their pharmaceuticals, which limit the amount consumers pay for a drug. The price controls cover the cost of the product itself, but they don’t cover all the cost of the research. American consumers are left with the remainder.

“It’s a free market system, so the U.S. economy picks up most of the price of all the worldwide research,” Shepherd says. “We may end up with price controls in this country, and that will satisfy the needs of today, but it won’t provide for tomorrow’s future drugs. I don’t have a good answer for it.”

For consumers trying to balance their pocketbooks with their medication needs, Shepherd advises they make sure they are taking advantage of any prescription drug programs available to them, from the recent Medicare changes for seniors to other government and community programs.

Source: University of Texas at Austin

Dharma Therapeutics, Inc., (”Dharma”) Seattle, WA (a subsidiary of the Transcu Group Limited, a company listed on the Singapore Exchange Limited) announced that its improved active transdermal delivery technology, which administers lidocaine and epinephrine through the skin via a mild electric current, has demonstrated safety and efficacy in a Phase 2 clinical trial.

About the Trial:

The trial conducted was a Phase 2, double-blind, randomized, placebo-controlled, two-arm study evaluating the safety and efficacy of the administration of lidocaine and epinephrine using the IDDS to provide topical anesthesia in adults undergoing a venipuncture procedure. Eighty-nine (89) healthy volunteer subjects were treated at two clinical sites. The trial included subjects representing a wide range of ages and ethnicity. Subjects were randomized to receive an 8 minute administration of lidocaine plus epinephrine (Active arm) or epinephrine alone (Placebo arm) at the site of insertion of an intravenous catheter. After placement of the intravenous catheter, subjects evaluated their pain using the Visual Analog pain Scale (VAS) scoring system and were asked if they would use the IDDS again. Safety of the treatment was also monitored during the trial.

Results:

In the Per-Protocol population (including subjects completing 8 minutes of treatment) the mean Visual Analog pain Scale (VAS) results recorded by the subject following the venipuncture procedure were 16.4 mm for the Active treatment versus 24.0 mm for the Placebo treatment (p=0.0235). Therefore, the trial demonstrated statistically lower VAS scores for the Active group as compared to the Placebo group. In addition, more than 80% of the Active group reported pain elimination and willingness to undergo IDDS treatment again. The IDDS treatment was well tolerated, with no serious adverse event reported in any subject.

“This represents a major advancement for Dharma and the Transcu Group,” said Paul R. Sleath, President and CEO of Dharma Therapeutics. “We are very excited about this product and the improvements over Dharma’s prototype evaluated in earlier clinical trials. Our current design is very user friendly and can be manufactured cost efficiently at commercial scale. We believe our product will be highly attractive to consumers, as it has been designed to meet the market demand for a low cost, fast onset local anesthesia product.”

Dharma has an end-of-phase 2 meeting scheduled with the Food and Drug Administration for this fall and plans to embark on pivotal Phase 3 trials in early 2010.

Source: Dharma Therapeutics, Inc

CEL-SCI Corporation (NYSE Amex: CVM), a late stage cancer immunotherapy company, announced that Dr. Eyal Talor, CEL-SCI’s Senior Vice President of Research and Manufacturing, has been invited to present to the NIH, NCI’s Clinical Center and the Center for Human Immunology, NERD (New Research and Development) Seminar Series, which will take place on Friday July 10, 2009 at the NIH’s Clinical Center located at the main NIH campus, on 9000 Rockville Pike, Bethesda, MD. The title of Dr. Talor’s presentation is: “Multikine: Cancer Immunotherapy; how to make immunotherapy for cancer work”.

In the presentation, Dr. Talor will discuss Multikine’s immunotherapy clinical program for cancer, the unique mechanism of action of Multikine (published in the Journal of Clinical Oncology) and the way Multikine imparts the patient’s own immune response with the ability to mount a robust anti-tumor immune response against his/her tumor. Dr. Talor will also discuss the clinical findings from the different Multikine Phase II clinical trials which highlight the advantages that Multikine treatment provides for early disease management in newly diagnosed (treatment naive) patients with Squamous Cell Carcinoma of the Head and Neck. Early intervention in this disease is seen by many clinicians and researchers in the field as a key to improving disease outcome in these patients.

Dr. Talor will also discuss the objectives of the collaborative study between the NIH, NCI under a current Material Transfer Agreement. This work is aimed at elucidating the tumor microenvironment changes, at the molecular level, brought about by Multikine treatment of head and neck cancer patients. The CEL-SCI / NIH collaborative study will use samples collected from patients with advanced primary Head and Neck cancer (Oral Squamous Cell Carcinoma) during the impending Multikine Pivotal Global Phase III trial and these samples will be tested by the NIH, NCI using Genomic Microarray technology, developed at the NIH, NCI laboratories.

About CEL-SCI Corporation

CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine(R) which is being readied for a global Phase III trial in advanced primary head and neck cancer. CEL-SCI is also developing a vaccine to prevent and treat swine and other influenzas using its L.E.A.P.S.(TM) technology platform and expects to soon finish the validation of its state-of-the-art facility in Maryland which it expects to utilize to launch aseptic filling for stem cell produced therapies and other biological products. The Company has operations in Vienna, Virginia, and Baltimore, Maryland.

When used in this report, the words “intends,” “believes,” “anticipated” and “expects” and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company’s potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation’s SEC filings, including but not limited to its report on Form 10- K/A for the year ended September 30, 2008. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Source: CEL-SCI Corporation