Two articles in the Wall Street Journal regarding the use, misuse and theft of drug patents...Of course all the drugs made by Thai-government run companies will be used for the poor and be of top quality....And none of them will ever make it onto the black market because there are SO many limits placed on selling inferior or bogus drugs to unsuspecting people in poor countries...



http://online.wsj.com/article/SB120515886199824251.html?mod=djempersonal

http://online.wsj.com/article/BT-CO-20080310-706680.html?mod=djempersonal

You mean that thing about counterfeit drugs is for real! (After all, if it's on the front page of the New York Times it must be important.)

Here's a link to Walt Bogdanich's story in today's Gray Lady:

http://www.nytimes.com/2007/12/17/world/middleeast/17freezone.html?hp

To whet your appetite, here's how it begins ...

DUBAI, United Arab Emirates — Along a seemingly endless row of identical gray warehouses, a lone guard stands watch over a shuttered storage area with a peeling green and yellow sign: Euro Gulf Trading.

Three months ago, when the authorities announced that they had seized a large cache of counterfeit drugs from Euro Gulf’s warehouse deep inside a sprawling free trade zone here, they gave no hint of the raid’s global significance.

But an examination of the case reveals its link to a complex supply chain of fake drugs that ran from China through Hong Kong, the United Arab Emirates, Britain and the Bahamas, ultimately leading to an Internet pharmacy whose American customers believed they were buying medicine from Canada, according to interviews with regulators and drug company investigators in six countries.

The seizure highlights how counterfeit drugs move in a global economy, and why they are so difficult to trace. And it underscores the role played by free trade zones — areas specially designated by a growing number of countries to encourage trade, where tariffs are waived and there is minimal regulatory oversight.

And yet some members of Congress want to decrease regulatory oversight of counterfeiting. Go figure.

From The Times of London ...

Fake world of the Viagra plotters

For tens of thousands of men the medicines offered by Ashish Halai and his gang appeared to be the answer to two of their most worrying and embarrassing health concerns: impotence and baldness.

But the unsuspecting customers, buying what they thought were Viagra and Propecia, were victims of one of the most ambitious and elaborate of counterfeiting crimes. Halai and his associates were buying fake drugs from Chinese suppliers for as little as 25p a tablet and selling them for up to £20.

Details of their vast network – stretching from Britain to Hong Kong, Dubai, the US and the Bahamas – emerged yesterday as justice finally caught up with the conmen.

In the largest drug counterfeiting case in Britain, and after a trial lasting more than seven months, Halai, 33, was jailed at Kingston Crown Court for four and a half years as one of the key players in the plot.

From his £1 million home in Borehamwood, Hertfordshire, he helped to mastermind an operation in which fake pills were produced at secret factories in China and Pakistan and smuggled to the US and Europe. The rewards, the court was told, were “immense”.

The investigation, the largest conducted by the Medicines and Health-care products Regulatory Agency (MHRA), uncovered profits of more than £2 million. The agency said that this was the “tip of the iceberg”.

“The geographical spread was global and the financial rewards were immense,” Sandip Patel, for the prosecution, told the court.

The case dates back to 2003 and 2004, when counterfeit batches of Viagra and Cialis, impotence drugs made by Pfizer and Eli Lilly, were seized while being smuggled into Heathrow and Stansted airports.

The MHRA immediately launched an investigation which alerted them to a major manufacturing and smuggling operation. Samples showed that the medicines contained about 90 per cent of the active pharmaceutical ingredients found in genuine tablets. Most of the fake pills were sold via the In 2003 the MHRA contacted the US Food and Drug Administration, which seized 8,000 packages of Viagra in Miami. Then, in July 2003, MHRA officers seized more than 120,000 fake Viagra tablets. internet, but some found their way into chemists were they were sold as prescription medicines.

The full story can be found here:

http://www.timesonline.co.uk/tol/life_and_style/health/article2477868.ece?EMC-Bltn

Caveat emptor is not sound health care policy.

That oft repeated question by the proponents of drug importation. Sadly, today's answer is, in Vancouver.

Here's the news from Canada's newspaper of record, the Toronto Globe & Mail.

ONLINE PHARMACIES

Counterfeit drugs caused woman's death, coroner concludes
ARMINA LIGAYA

July 6, 2007

VANCOUVER -- Shoddy pills from a bogus online pharmacy are to blame for the death of a 58-year-old woman from Vancouver Island, a coroner's report says.

Yesterday's conclusion makes Marcia Bergeron the first clear-cut case of a death stemming from counterfeit drugs bought on the Internet, but it likely won't be the last, said Rose Stanton, regional coroner for Vancouver Island.

"The quantity of seized counterfeit medication is huge," she said. "And so, what we have is the first person [for whom] we have all the facts, who we know died as a result of these drugs.

"But what we also know is lots of people are buying these drugs. So the potential for more deaths is high."

Ms. Bergeron was found by a friend on Dec. 28, 2006, in her bed in a normal sleeping position. Emergency services were called, but it was clear she had been dead for some time.

Three types of pills were found at Ms. Bergeron's home. One contained Zolpidem, a powerful hypnotic not available in Canada. Another contained the anti-anxiety medication Alprazolam, which is available with a prescription, and the third contained acetaminophen.

These drugs were later determined to be laced with extremely high quantities of metal. The acetaminophen pill had 15 times the amount of aluminum that would be fatal, Ms. Stanton said.

An autopsy showed that Ms. Bergeron died of cardiac arrhythmia stemming from metal toxicity.

In the weeks and months leading up to her death, she complained of flu-like symptoms. Ms. Bergeron said, in e-mails to a friend, that her hair was falling out, and she suffered from nausea, diarrhea, aching joints and blurry vision.

When the pills were tested, they were of such poor quality, the ingredients seemed "mashed together" Ms. Stanton said. The mixture of drugs and metal in each pill would vary depending on which portion was examined, she said.

The metal contaminants were likely part of the filler materials used to make the pills, the coroner's report said.

On Ms. Bergeron's computer, records showed she had been visiting websites from which medication could be purchased.

When U.S. Food and Drug Administration investigators examined her hard drive, it showed Ms. Bergeron bought Zolpidem - a powerful sedative available by prescription in the U.S. but not in Canada.

The website she used, which purported to be Canadian but has since gone offline, was previously flagged by the FDA concerning counterfeit Zolpidem.

Because of all these elements - computer records, e-mails, drugs found on scene and a subsequent autopsy - investigators were able to definitively link the online drugs to Ms. Bergeron's death.

It's an FDA first, Ms. Stanton said.

She said the website Ms. Bergeron used is one of thousands that claim to be reputable pharmacies.

"The site that she purchased from is one of a group of sites that the FDA says use the tactic of phoning people after they get the first order," she said. "They phone for the renewal so there isn't a computer record."

Marnie Mitchell, CEO of the B.C. Pharmacy Association said that Canada has a very regulated and monitored pharmacy system, and stepping away from it has risks.

"Online sources are very difficult to assess their legitimacy and their safety," she said. "This is a very tragic episode and illustration of the problems that stem from going to those kinds of places."

Cracking down on these websites, however, would be a difficult endeavour, she said, because they change and shift very quickly and are hard to trace.

Instead, she recommended the federal government launch a public-awareness campaign to warn people of the potential dangers.

Alain Desroches, spokesperson for Health Canada said the agency regularly flags counterfeit products and issues public advisories. It also works with RCMP in investigating counterfeit drugs. However, he could not comment on any policy changes that would stem from the coroner's findings.

"We welcome the report and it's going to be reviewed carefully," he said.

China said late Tuesday that it was overhauling its food and drug safety regulations and would introduce nationwide inspections.

According to the New York Times, “The announcement, from the State Council, the nation’s highest administrative body, is the strongest signal yet that Beijing is moving to crack down on the sale of dangerous food and medicine and trying to calm fears that some of its exports pose health problems.

The government said in its announcement that it planned by 2010 to place new controls on food and drug imports and exports and to step up random testing on medicines. It also said that it would have information on inspections of 90 percent of all food products, although it was unclear how that would work.

Food and drug safety experts have complained for years about a flawed system that has led to food scares or mass poisonings tied to counterfeit or substandard medicines on the market.”

Here’s a link to the complete article:

http://www.nytimes.com/2007/06/07/business/worldbusiness/07safety.html?hp

If our political leaders are truly concerned about drug safety (as so many are and as many others claim to be) we should hold China’s feet to the fire and make sure these reforms (which sound good) are implemented – and with alacrity.

From the Moscow Times ...

The State Duma will examine plans to stiffen penalties for manufacturers and distributors of counterfeit pharmaceuticals Friday, one of the sponsors of the proposed bill said Thursday.

"It will be the first reading of a bill to create a new statute in the legal code covering the manufacture, intent to supply, supply, storage, transportation and importation of counterfeit pharmaceuticals," said Pyotr Shelishch, a member of the Duma's Legislation Committee.

Counterfeit medicine is a serious problem on the Russian market, Shelishch said.

"It's difficult to say what the amount of counterfeit drugs is, but estimates range from fractions of a percentage up to 10 percent," he said. The country's pharmaceutical market is worth around $10.7 billion, according to estimates by industry consultant Pharmexpert

According to the new proposals, the minimum penalty would rise to 500,000 rubles ($20,000) and the maximum penalty would be a 15-year prison term, Shelishch said.

"The maximum sentence would be applicable if it led to the deaths of two or more people," he said.

The new measures come as a result of glaring shortcomings in existing legislation, lawmakers and analysts said.

"I welcome this new move, as we still do not have any law to punish those people that produce counterfeit drugs in Russia," said Nikolai Demidov, general director of Pharmexpert.

In November, pharmaceuticals firm Bryntsalov-A was handed a 40,000 ruble fine after being found guilty of offenses including the improper storage of drugs.

Manufacturers welcomed the proposed legislation but said new laws needed to be backed up by tougher action. "Any changes in legislation should be followed by relevant enforcement measures. Legislative amendments are meaningless without strong support of control activities from executive authorities," a GlaxoSmithKline Russia spokesman said.

"We would like to see examples being made where those found to knowingly trade in counterfeit medicines are prosecuted and receive meaningful penalties," the spokesman said. "We would also like to see an increase in checks on pharmacies and warehouses."

With international standards such as the good manufacturing practices code as yet not obligatory in Russia, Demidov said overall production control needed to be sharpened.

The prevalence of counterfeit medicine in the country has consistently been one of the major factors hampering Russia's entry into the World Trade Organization.

"Of course we are thinking first of all about our citizens, but if these measures help facilitate Russia's entry into the WTO, then that is also positive," Shelishch said.

The urgency of these requirements makes it likely that the legislative changes will be passed by the end of the year, Demidov said.

"I hope that this law will be adopted not later than September. I am linking this with the WTO membership bid," he said.

It's a good start, but the Russian government can still Duma. (Get it.)

According to Dr. Valerio Reggi, chief of the anticounterfeiting task force created last year by the WHO (and as reported in the New York Times), in many countries, "counterfeiting a T-shirt means 10 years in jail, but counterfeiting a medicine can be a misdemeanor."

A deadly misdemeanor.

A federal court judge has imposed a temporary injunction against the FDA over the agency's drug pedigree requirements, on the basis that the regulations leave sections of the supply chain unguarded and threaten the survival of smaller drug distributors.

Here’s a link to the complete story:

The Prescription Drug Marketing Act (PDMA), originally put into force in 1988, outlines the requirement for a drug pedigree – a statement of origin that identifies each prior sale, purchase or trade of a drug right back to the manufacturer. However, Authorized Distributors (ADs) are exempt from having to provide pedigrees for the drugs they provide, thus leaving sections of the supply chain unmonitored and pedigrees hard to establish further down the line. Authorized distributors are somewhat hazily defined as those who have ongoing relationships with manufacturers, identifiable by evidence of repeated transactions with the manufacturer. Over 90 per cent of the drug wholesale industry in the US is controlled by a handful of companies who are authorized distributors. This group is commonly referred to as the Big Five, made up of McKesson, Bergen Brunswig, AmeriSource, Cardinal Health and Bindley Western.

The exemption means that ADs tend not to maintain or pass on pedigrees for the products they obtain from manufacturers. This becomes problematic when those further down the supply chain, ‘unauthorized’ distributors for example, are required to provide pedigrees right back to the manufacturer. It also means that over 90 per cent of the prescription drugs in the US are essentially uncovered by the PDMA’s security measures.

This issue is further exacerbated by the fact that ADs are not required to provide a pedigree even if they themselves obtained the products from a secondary wholesaler. The FDA themselves noted that some drugs may go through several transaction cycles involving multiple primary and secondary wholesalers before arriving at their retail destination. According to the National Wholesale Druggists’ Association, the Big Five purchase 2-4 per cent of their products from sources other than manufacturers, and one of the group reported that $350 million of their total inventory came from non-manufacturer vendors.

Excellent "special report" on counterfeit prescription medicines in the December 18, 2006 edition of BusinessWeek.

Here's the link:

http://www.businessweek.com/magazine/content/06_51/b4014064.htm

Two snippets to whet your appetite for more ...

First, as to the scope of the problem:

* Based on a study of 185 sites, Columbia University's National Center on Addiction & Substance Abuse reports that only 11% of Internet pharmacies require customers to provide a prescription. All the rest, an astounding 89%, appear to operate illegally. Conservative estimates of the number of dubious sites reach into the tens of thousands, according to Internet Crimes Group Inc., a corporate consulting firm.

And second, to those politicians and pundits who claim that counterfeiting is nothing but a Big Pharma "scare tactic," a cautionary tale:

* Craig Schmidt fell victim to questionable Internet medicine in April, 2004. The Chicago plastics salesman, then 30, was feeling the stress and back pain of long workweeks often spent on the road. Checking his e-mail one day, he noticed ads for Xanax and the painkiller Ultram. He placed $400 in orders without ever speaking to a doctor. When the pills arrived, he took one tablet of each drug and headed for an errand at the hardware store. The next thing he remembers is waking up three weeks later in the hospital. It turned out that each Xanax tablet contained 2 mg of the drug, or quadruple the usual starting dosage. The combination apparently caused him to black out and wreck his car. He had a heart attack, fell into a coma, and suffered brain damage. After an extraordinary recovery, he still takes medication to prevent severe leg spasms. "Don't do what I did," he says. "It's like playing Russian roulette."

BusinessWeek also ordered some "product" from selected websites. The Xanax the investigative team ordered had zero active ingredient, as did the Lipitor it purchased.

Well say it again -- counterfeiting of prescription medicines is nothing short of international prescription drug terrorism.

Just got back from two very stimulating events. One was in Brussels, the other in Stockholm. Both were launch events for "Coincidence or Crisis," our new book on the issue of counterfeit medicines.

The Brussels event, as you might suppose, was attended by many NGOs, EU commission members, WIPO, government representatives from around the world (Cyprus, the US, Lithuania, etc.), the EAEPC (the association of parallel traders), members of the euro-press (Le Figaro, Le Soir, the Daily Mail etc.), and Bill Newton Dunn, MEP (Member of the European Parliament). Mr. Dunn also contributed an introduction to "Coincidence or Crisis" along with Congressman Mark Souder. The counterfeiting of prescription medicines is, after all, a global problem.

The Stockholm event took a different direction, attended by the media too, but also by members of the Swedish medical media, Swedish regulators, pharmacists, and patient groups. Mr. Finn Bengtsson, a member of the Swedish parliament and a professor of pharmacology also spoke at the event -- and promised to raise this issue within the government.

Here is one of the media reports of the Stockholm event:

http://www2.unt.se/avd2/1,3908,MC=3-AV_ID=558953,00.html

And, as always, more information on the issue of counterfeit drugs, as well as on "Coincidence or Crisis" can be found at http://www.cmpi.org.

Why is the book called "Coincidence or Crisis" -- because there is no such thing as a coincidence.