June 26, 2008

Repack Attack

by Peter Pitts

pharmaceutical industry in Europe is calling for a ban on the repackaging of medicines within the European Union in order to stamp out the growing threat of counterfeits.

This is not a new idea – but it’s a good one. But it’s often derided as the pharmaceutical industry calling for a policy change for reasons of self-interest rather than public health.

But at the recent BIO convention in San Diego a European Commission representative said that Brussels is seriously considering proposals that would ban repackaging – a move that, if taken would (according to Reuters), “deal a blow to the parallel trade and could also help drugmakers' profits, since companies' revenues are currently eroded by arbitrage dealings in their products across borders.”

Does this mean that the European Commission is in the “pocket of Big Pharma?”

Hardly.

(In fact, it’s humorous considering the way the industry is treated over there.)

What it does mean is that, enfin; the EC is taking seriously what we here at drugwonks.com have been saying for some time – that parallel trade is the weak link in the pharmaceutical chain of custody and a prime target for counterfeit infiltration.

It’s also important to note that what the Europeans call “parallel trade,” we refer to as “importation.” And that Canadian Internet pharmacies get their drugs from Europe. (Note: over 20% of all pharmaceuticals legally sold in the UK are parallel traded into that island nation from other nations within the EU such as Greece, Latvia, Portugal, and Malta and often illegally from places such as Russia and Turkey.

“Safe” importation?

Perhaps in a parallel universe.

Posted by peterpitts at 01:29 PM
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June 09, 2008

The Counterfeiting Superhighway

by Peter Pitts

Last week, in Washington DC, I spoke at the Fourth Global Forum on Pharmaceutical Anticounterfeiting. My talk was why we won’t see legalized drug importation after the November elections – regardless of who gets elected.

There are four basic reasons:

1- It won’t save any money.

2- The drugs being sent to U.S. customers from Canadian Internet. pharmacies are not “the same drugs Canadians get.”

3- The state experience has been dismal and politically embarrassing.

4- National Security concerns.

(For more detail on these points click here:

http://www.drugwonks.com/blog_post/show/5011

Adding fuel to the reality is a new report just made public at the conference, by the European Alliance for Access to Safe Medicines (www.eaasm.eu). The title says it all, “The Counterfeiting Superhighway.”

The report reveals the scope of the unregulated trade of fake pharmaceuticals. Through extensive research and examination of over 100 online pharmacies and over 30 commonly purchased prescription-only medicines, the report makes one thing very clear – we’re not winning the battle.

Key findings from this report

• 62% of medicines purchased online are fake or substandard (including medicines indicated to treat serious conditions such as cardiovascular and respiratory disease, neurological disorders, and mental health conditions).

• 95.6% of online pharmacies researched are operating illegally.

• 94% of websites do not have a named, verifiable pharmacist.

• Over 90% of websites supply prescription-only medicines without a prescription.

• 78.8 of websites violate intellectual property.

My favorite anecdote is the report’s example of an Internet pharmacy whose products came wrapped in pages from the Mumbai Daily News. The most frightening fact, though, is most of the fake medicines “were delivered in seemingly authentic boxes, accompanied by patient information leaflets in good condition and ostensibly trustworthy blister packs.”

The report concludes by providing recommendations based on the research findings and calls all stakeholders including search engines, credit card companies, shipping companies, patient groups and regulators, to take action and halt this dangerous trend.

Bravo.

The full report can be found at:

http://www.eaasm.eu/Media_Centre/News/The_Counterfeiting_Superhighway

Drug importation is not on their list of solutions.

The take-away for U.S. electoral rhetoric is obvious – Senator McCain and Senator Obama cannot be for enhanced drug safety and for drug importation. It’s simply does not compute.

Posted by peterpitts at 12:16 PM
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May 21, 2008

Cell Culture

by Peter Pitts

At a recent European Commission-sponsored high level conference, Internal Market Commissioner Charlie McCreevy, commented that the EC wants practical, pragmatic suggestions for fighting the “modern-day highway robbery” known as piracy and counterfeiting. McCreevy stressed that more regulation is not the answer, and that solutions lie with public-private cooperation.

Don’t get me wrong – I’m all for free-market solutions and public/private cooperation. But when it comes to counterfeit prescription medicines (aka: International Health Care Terrorism) national and international law enforcement agencies as well as domestic criminal justice officials must engage in the debate. And actively. And immediately.

Only governments can put into place enhanced investigatory assets and harsher penalties.

Public/Private cooperation? Certainly. But only governments can catch and keep criminals in jail.

When it comes to discouraging international prescription drug counterfeiting, what we need is a more robust cell culture.

Posted by peterpitts at 06:44 AM
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May 12, 2008

The Lancet on Counterfeits

by Peter Pitts

The Lancet 2008; 371:1551
DOI:10.1016/S0140-6736(08)60663-7

Editorial

Combating counterfeit drugs

Last week, the US Food and Drug Administration (FDA) told a Congressional hearing that it believes a contaminant found in batches of heparin, which have killed at least 81 patients, might have been deliberately added. The source of the contaminant—oversulfated chondroitin sulphate—has been traced back to a Chinese supplier of drug manufacturer Baxter International. Why the stocks might have been intentionally contaminated is unclear, but the fact that oversulfated chondroitin sulphate is structurally similar to heparin but about 100 times cheaper, raises the very real possibility that it could have been added by counterfeiters.

If counterfeiting is behind the heparin case, it would not be that surprising; trends indicate that counterfeit medicines, defined by WHO as drugs that have “been deliberately and fraudulently mislabelled with respect to identity and/or source”, are a growing, global problem. The FDA alone has seen an 800% increase in the number of new counterfeit cases between 2000 and 2006. In developing countries, where drug regulatory systems can be weak or non-existent, around 10–30% of medicines might be counterfeit. Antimalarials have been a particular target for counterfeiters, and fakes have flooded the market in many Asian countries.

The substances used to adulterate medicines can vary from chalk, to antibiotics, to highly lethal substances that cause alarming spikes in mortality rates. Subtherapeutic levels of the genuine medicine, such as an antimalarial, can also lead to death or the development of fatal drug resistance. But these deaths, mainly in developing countries, are largely hidden in public-health statistics.

This situation is only likely to worsen as counterfeit drugs are becoming more difficult to combat. Criminals are using more sophisticated techniques to bypass standard laboratory testing such as the addition of cheaper substances that mimic genuine drugs. Holograms on drug packaging, designed to make counterfeiting more difficult, are also being copied with increasing accuracy making boxes of fake products hard to detect by the human eye. These deceptive measures have unfortunately led to a booming, lucrative trade. The Center for Medicine and the Public Interest estimates the sales of counterfeit drugs will reach US$75 billion in 2010. So what is being done to address the problem?

At the international level, the World Health Assembly adopted a resolution against counterfeit and substandard drugs in 1988, and at the end of 2006, the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) was set up by WHO to mobilise action. However, despite these moves, few concrete steps have been taken by countries and political will to adopt anti-counterfeiting measures is lacking.

Most WHO member states are doing a poor job of reporting counterfeiting cases. Incredibly, between 2002 and 2004, WHO received no reports of counterfeit drugs. In many countries, counterfeiting medicines is not even considered a crime and when it is, the penalties for those found guilty often do not tally with the severity of the action. For example, in the UK, the prison sentence and fine for counterfeiting a T-shirt with a trademarked logo can be greater than for counterfeiting a medicine. Tougher prison sentences and heftier fines need to be introduced by governments to deter counterfeiters.

Countries must also strengthen their ability to regulate the drug supply. According to WHO, only 20% of its member states have well-developed drug regulatory systems, and around 30% have no or weak drug regulation. Twinning food and drug authorities in rich countries with ones in resource-poor countries might help nations that are struggling to regulate the market. Drug authorities also need to work effectively with customs, the police, scientists, health workers, WHO, and INTERPOL. This type of collaborative approach has proved successful in tackling counterfeit antimalarials in southeast Asia.

The pharmaceutical industry also has its part to play. It should be legally required to report suspected cases of counterfeiting to the relevant national drug authority—a practice which is currently voluntary. Companies must also be encouraged to lower the prices of their products in developing countries to reduce the economic incentive for counterfeiters.

There is no magic bullet to deal with counterfeit medicines. Countries need to adopt multipronged, multidicisplinary approaches to combat the problem. WHO and donor countries should provide support to developing nations to strengthen their drug regulatory systems. But individual governmental commitment to this goal is essential. Without it, public safety will continue to be compromised.

Posted by peterpitts at 07:37 AM
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May 08, 2008

Lord of the Flies

by Peter Pitts

Chinese regulators are accusing Baxter of failing to co-operate in an investigation over deaths linked to impurities in blood thinner heparin.

The State Food and Drug Administration, China’s drugs regulator, said on Tuesday that Baxter had not provided all samples and information requested during a visit last month to its New Jersey plant. The SFDA reiterated its position that there was no proven link between the deaths in the US of patients and “a heparin-like substance” found in the drug.

Denial, as my mother used to say, is more than just a river in Egypt.

Baxter replied: “We have been co-operating with all parties in the heparin situation including SFDA and the Chinese government. We plan to continue co-operating with them to help move the investigation forward. We will seek to understand any concerns to the contrary.”

Per the larger issue of “tainted” vs. “counterfeit” ingredients, consider the comments of Robert Parkinson, Baxter’s chief executive, who said that the issue in question “appears to be the target of a deliberate adulteration scheme.”

Translation: Counterfeiting.

There are a lot of issues here that need to be addressed – most notably criminal opportunism.

Consider the Chinese proverb, “Flies never visit an egg that has no crack.”

We must seal the cracks.

Posted by peterpitts at 07:35 AM
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May 07, 2008

False Profits

by Peter Pitts

In 2006 the Center for Medicine in the Public Interest (www.cmpi.org), estimated that counterfeit drug commerce will grow 13% annually through 2010. The CMPI study is cited by the WHO on its updated counterfeit pharmaceuticals fact sheet.

Counterfeit sales are increasing at nearly twice the rate of legitimate pharmaceutical sales and they are a money machine. In 2010 CMPI estimates that fake drugs will generate $75 billion in revenues — a 92% increase from 2005. And the risks of detection and prosecution are low.

CMPI's original estimates were made based on conservative projections of counterfeit medicines manufacture and sales issued by the WHO, the FDA, the EU Commission and other global bodies.

But now these numbers are too low – because an entirely new criminal enterprise has emerged – counterfeit ingredients. While counterfeit API (active pharmaceutical ingredient) isn’t a new issue, there is a new and frightening manifestation. In the past, counterfeit API was purchased by criminals making counterfeit drugs. Today a new, significantly more dangerous and difficult to fight enterprise is underway – the sale of counterfeit (“tainted”) ingredients to legitimate pharmaceutical manufacturers. The most high profile example of this is the deadly case of Heparin.

It is impossible to believe that the case of Heparin was an unfortunate mistake – a quality lapse, a one-time and unique circumstance. The facts speak otherwise. This was a case of fraud. Criminal fraud. So let’s call it by its proper name -- counterfeiting.

Counterfeit medicines, according to the WHO are “deliberately and fraudulently mislabeled with respect to identity or source. Counterfeiting occurs both with branded and generic products and counterfeit medicines may include products with the correct ingredients but fake packaging, with the wrong ingredients, without active ingredients or with insufficient active ingredients.”

It’s time to rethink and broaden that definition to include the potential for fake ingredients (“tainted” is both too polite and too inaccurate a term) that insidiously find their way into legitimate pharmaceutical manufacturing.

Posted by peterpitts at 02:31 PM
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June 01, 2007

Chinese Checkers

by Peter Pitts

As any assistant district attorney will tell you, the "some other guy did it" defense generally means "guilty."

Now, it seems, China is blaming Panama for the deaths of 51 people caused by cough syrup containing Diethylene glycol -- a chemical commonly used in antifreeze and brake fluid. But, it seems, there is plenty of blame to go around.

This is just the latest example of China-as-hub for the international trade in counterfeit API (Active Pharmaceutical Ingredient). And connecting the dots to the issue of "safe" drug importation is pretty obvious.

Here's the story off the AP wire:

China blames Panama for deadly tainted drugs

Papers altered to say glycerin was for medical use, Chinese official claims

BEIJING - Businesses in Panama, not China were "mainly responsible" for passing off an industrial chemical as a medical ingredient leading to the deaths of at least 51 people, a senior official in China's product-inspection agency said Thursday.

Wei Chuanzhong, vice minister of the Administration for Quality Supervision, Inspection and Quarantine, said Chinese companies sold the industrial solvent called 'TD glycerin' to Spanish companies who then sold it to Panamanian companies. The product was then used to make cough syrup and other medicine.

"The Panamanian business people are mainly responsible because they changed the scope of use and shelf-life of this product," Wei said.

The deaths in Panama, which began last year, have dramatically added to a growing international alarm about the safety of food and medicines exported by China.

Wei acknowledged that the Chinese manufacturer, Taixing Glycerin Factory, and the Chinese distributor, CNSC Fortune Way, "engaged in some misconduct," because they used the name TD glycerin for a mix of 15 percent diethylene glycol and "other substances."

Diethylene glycol is a chemical commonly used in antifreeze and brake fluid.

Misleading name

"They used the very confusing name of TD glycerin, which will mislead people to think it's glycerin," said Wei. "The markings on the package also used the name glycerin instead of TD glycerin."

But he said the Panama traders bore the brunt of the responsibility for the deadly substance ending up in medicine.

"The Panama trader changed or altered the paperwork to say the substance was medical glycerin that met U.S. standards for use in medical products and changed the shelf life of the already expired product from one year to four years," Wei said. "The responsibility here is very clear."

He said the Chinese investigation found that the Chinese side made it clear in their export paperwork that the material they were selling was for industrial, not medical, use. Wei said Taixing had been punished for its misbehavior but when pressed for details, he said the company was still being investigated. He said China would not continue to allow the use of the name TD glycerin, but no ban has been formally announced.

Glycerin, which is often processed from animal fats and occurs naturally in the human body, is a sweet liquid that can give cough syrup and other remedies thickness while preventing them from dissolving in water. It is used in many kinds of medicines all over the world.

The first documented poisonings were reported in October, but Panamanian authorities said there may have been earlier cases that went undetected. Fifty-one people died after taking the tainted medications and 68 were hospitalized.

Why isn't Senator Bernie Sanders asking, "Where are the dead Panamanians?

Posted by peterpitts at 08:49 AM
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January 04, 2007

Bitter Pills

by Peter Pitts

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.

Counterfeiting of prescription medicines is nothing short of international prescription drug terrorism.

Posted by Peter Pitts at 08:56 AM
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December 12, 2006

Gray Lady on Gray Market

by Peter Pitts

Editorial from today's edition of the New York Times:

Editorial
Fighting Drug Fakes
Published: December 12, 2006

Tempted to buy cheap medicines from a pharmacy Web site? Think twice. If the Web site shows no verifiable street address for the pharmacy, there is a 50 percent chance the drugs are counterfeit.

In rich countries, fake medicines mainly come from virtual stores. Elsewhere, they are on the pharmacy shelves. In much of the former Soviet Union, 20 percent of the drugs on sale are fakes. In parts of Africa, Asia and Latin America, 30 percent are counterfeit. The culprits range from mom-and-pop operations processing chalk in their garages to organized-crime networks that buy the complicity of regulators, customs officials and pharmacists.

In Panama, dozens of people died after taking counterfeit drugs made with an industrial solvent. Often counterfeiters put in real ingredients for their smell or taste, but heavily diluted. This has sped the emergence of resistant strains of infections, and is probably a big reason some malaria drugs and antibiotics have lost their power.

Drug counterfeiting can be fought. Five years ago, the majority of Nigeria’s drugs were fakes, and the country was a major source of counterfeits abroad. When the Nigerian government donated 88,000 doses of meningitis vaccine to Niger during an epidemic in 1995, the vaccine turned out to be a fake — causing more than 2,500 children to die.

Now the possibility that a drug is fake in Nigeria has dropped to 17 percent, according to the World Health Organization. The country’s drug control agency is informing people through radio and TV jingles about fake medicines. It has also fired corrupt officials, hired a fleet of inspectors to drop in on pharmacies, banned imports from some 30 companies, and begun prosecuting counterfeiters.

One of the problems Nigeria still faces is that the penalty for counterfeiting medicine is as little as a $70 fine — a small price to pay for a crime that can reap a fortune. All over the developing world, governments treat falsifying medicines as a mere copyright infringement, rather than potential murder.

The W.H.O. has recently set up a task force that brings together many groups that work on counterfeit drugs. It is a start. Multinational drug companies — which have been reluctant to report fakes lest they erode consumer confidence in all drugs — need to do more. An international convention is also needed to establish stiffer penalties for counterfeiting drugs, and marshal more funds and support to fight this deadly crime.

Wonder if Senator Vitter will put a "hold" on his subscription to the Gray Lady?

All the news that's fit to print. Amen.

Posted by Peter Pitts at 04:26 PM
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October 18, 2006

The China Syndrome

by Peter Pitts

How is the spread of counterfeit prescription drugs being addressed in China?

Interesting new article in "Insight" (the official publication of the American Chamber of Commerce in Shanghai) that, indeed, offers insight into the views of PRC officials -- and the actions they are taking (or say they are taking) to combat the issue of prescription drug counterfeiting (aka: international health care terrorism).

See for yourself:

http://www.amcham-shanghai.org/AmChamPortal/MCMS/Presentation/InsightDetail.aspx?Guid={9D628132-7DEA-432E-B18B-C0E27AC73E37

Posted by Peter Pitts at 02:20 PM
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August 18, 2006

Flipping the Bird

by Peter Pitts

Focusing on prescription drug counterfeiting as international health care terrorism is often trivialized by pols and pundits as “just another scare tactic of Big Pharma.” That argument has never held up under the facts (stubborn things those facts) — and here’s a new truth that should further force those who deny the threat of counterfeits to reconsider their position — efforts to control the spread of bird flu in poultry in Southeast Asia are being hampered by the use of ineffective and often fake agricultural vaccines. This according to Robert Webster, a British virologist, animal flu specialist, and director of the World Health Organization’s Collaborating Centre for Studies on the Ecology of Influenza in Animals and Birds. As a result the threat of the virus evolving and being able to pass to humans, triggering a potentially catastrophic pandemic grows. It’s time to wake up and address prescription drug counterfeiting as what it is — international health care terrorism.

Posted by Peter Pitts at 09:34 AM
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