USA Today: Growing Problem of Fake Drugs Hurting Patients, Companies

Counterfeit drugs made in Asia and other emerging markets are a growing problem that's endangering consumers' health and chipping away at drug companies' profits.

Kathy Chu in the Monday, September 13th issue of the USA Today writes an excellent story regarding the growing problem of counterfeit drugs globally. Ms. Chu cites some fresh industry statistics and pharmaceutical security insiders in her piece.

Here are some of the highlights from Ms. Chu’s USA Today article:

• Last year, nearly 1,700 incidents of counterfeit drugs were reported worldwide, triple the number in 2004, says the Pharmaceutical Security Institute (PSI), a group funded by drugmakers. Estimates for the size of the counterfeit drug market range from $75 billion to $200 billion a year. The market is likely much bigger because many cases are hard to detect.

• Fake drugs are a "money machine" whose sales are growing at twice the rate of legitimate pharmaceuticals, says Peter Pitts, president of the Center for Medicine in the Public Interest.

• A weak economy along with rising drug prices are likely leading consumers to seek out cheaper products online or from unauthorized providers, stoking demand for counterfeit drugs, says Bryan Liang, a board member at the Partnership for Safe Medicines. More than 50% of the medicine bought from certain illegal websites has been found to be fake, according to the World Health Organization.

• Scott Davis, a senior regional director in U.S. drug giant Pfizer’s global security division, believes it's not cheaper prices that drive consumers to counterfeit medicine, but their "lack of education and awareness of the dangers." Counterfeit medicine may include too much, too little or none of the ingredients found in the real product, causing injury and in extreme cases, death.

• Today, drug rings in Asia, particularly in China and India, are increasingly churning out fake versions of popular brands and generics, then selling them to consumers online or in the black market. PSI estimates that fake versions of about 800 pharmaceutical products were made last year.

• Counterfeiters are now able to fake drugs so well, even experts find it hard to distinguish the copies from the real deal. And they're able to replicate security devices such as holograms only a few months after pharmaceutical companies put these features on their packages.

• "You can make more money in counterfeit drugs than heroin," says Tom Kubic, CEO of PSI. "There's a major financial incentive for criminals because of the low risk of detection and prosecution."

• In many countries, penalties on fake drugmakers aren't strong enough to deter their illicit activities, says Lembit Rägo, coordinator for medicines quality and safety at the WHO. Countries including China, however, have stepped up their efforts related to detection and seizure of counterfeit drugs.

• Fake drugs also put pharmaceutical makers' profits at risk by diverting consumers away from the legitimate products, Liang says. While counterfeit drugs are more common in emerging economies, they also pose a threat to consumers in developed countries, such as the U.S., who are buying medicine online. "When the patient gets away from trusted sources, that's where I see the problem in the developed world," Davis says.

Huge profits, sophisticated criminals along with lax regulatory and legal penalties, make this the “perfect crime” that impacts the health and well being of entire populations often with deadly consequences.

This epidemic goes well beyond the unsophisticated supply chains of undeveloped nations, consumers all over the globe are unwittingly victims of this deadly act.

Pointed out in the article is the criminals ability to react to covert packaging protections, which means that they can easily fool basic Track and Trace technologies which currently comprises the majority of technologies used in defeating counterfeiters.

Secure Pharma Chain endorses authentication, as the most effective way in defeating counterfeiters and verifying that the products and inventories within the supply chain are genuine and safe for consumers to take.

To read the entire USA Today story, visit: http://www.usatoday.com/money/industries/health/2010-09-12-asia-counterfeit-drugs_N.htm.

To learn more about pharmaceutical authentication technologies, visit: http://www.xstreamsystems.net/.

USA Today: Voters Trust Drugs Made in US, But Few Actually Are

In an August 3rd story in the USA Today. Rita Rubin writes about a Pew Charitable Trust Prescription Project Poll that surveyed the trust of the average domestic US voter in prescription medications.

According to the Pew Poll, more than three out of four voters are confident that prescription drugs made in the US are free from contamination, while fewer than one in 10 feel confident about medications made in India or China.

This is troubling as Ms Rubin writes, because:

Unbeknownst to many Americans, an estimated 80% of the substances used to make or package drugs sold here are made in other countries, says Allan Coukell, a pharmacist who directs the medical safety portfolio for the Pew Health Group. And a growing proportion come from India or China. In 2007, 68% of ingredients of drugs sold worldwide came from India or China, vs. 49% in 2004.

Also in the USA Today article:

· Monitoring far-flung plants presents a logistical challenge to the Food and Drug Administration, Coukell says. "They clearly don't have the people or the resources they need to oversee manufacturing the way it exists today."
· In 2007 and 2008, more than 100 patients in the USA died after taking heparin made with a contaminated active ingredient from China.
· Complicating matters is the FDA's inability to order recalls of batches of drugs that might pose a risk, Coukell says. (The FDA can withdraw approval of a drug, taking it off the U.S. market entirely.)
· Even so, drug recalls soared 400% from 2008 to 2009, which saw a record 1,742, according to the Drug Safety and Accountability Act of 2010, to be introduced today by Sen. Michael Bennet, D-Colo. Bennet's bill would empower the FDA to order recalls of unsafe batches of drugs.
· According to the Pew random nationwide survey of 802 registered voters, 55% say the government should do more to ensure the safety of drugs made in other countries, and nearly nine in 10 back legislation to implement new drug safety measures.
· In an interview, Bennet said McNeil Consumer Healthcare's recall this year of more than 130 million bottles of over-the-counter children's medicines fueled his concerns. Referring to his daughters, ages 10, 9 and 6, he said, "I want to make sure any pharmaceuticals they're ingesting are safe."

Clearly consumers understand the potential issue of globally sourced drugs but are not informed as to the extent that the drugs that they take every day are manufactured or contain raw materials from countries with suspect or under regulated industry.

It is vital that members of the domestic pharmaceutical supply chain and domestic regulatory agencies deploy solutions and technologies to test the safety and efficacy of drugs and consumer goods produced overseas.

To learn more about authentication solutions that can protect consumers against fraudulent, substandard, adulterated or counterfeit medications, visit: http://www.xstreamsystems.net/.

To see the entire USA Today article, visit: http://www.usatoday.com/news/health/2010-08-03-recall03_ST_N.htm.

FDA Asks Physicians To Suspend Use Of Rotarix Due To Contamination

The FDA has asked the nation’s physicians to stop giving their patients Rotarix, a vaccine used to protect against rotavirus.

The recommendation came after the FDA became aware of an independent U.S. research team finding an unauthorized substance, porcine cirovirus 1, or PCB-1 DNA, in multiple samples of Rotarix.

According to CNN: "Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, said 'a substantial amount' of the DNA was found in the vaccine. But, he stressed, 'there is no evidence that it causes any disease. ... There is no evidence that it ever does anything.”

According to the New York Times: “For now, the decision is unlikely to disrupt routine immunizations in children since a second vaccine, this one made by Merck and called RotaTeq, remains available. RotaTeq was approved for use in the United States in 2006 and is still the more popular vaccine. Rotarix was approved in 2008 and has been used to vaccinate about one million children.”

The discovery of this virus, hastens the need for more robust Quality Control testing at all lengths of the supply chain, raw materials, manufacturer, distribution and the point of dispense to properly protect the healthcare of the global consumer.

A variety of news sources are reporting on the story including the New York Times, CNN, Wall Street Journal, Washington Post and USA Today.

To view the New York Times story, link to: http://www.nytimes.com/2010/03/23/health/policy/23fda.html.

To learn more about supply chain protections against contamination, adulteration, fraud or counterfeiting, visit: http://www.xstreamsystems.net/.