War on Counterfeit/Illegal Drugs Hobbled by Same Demons as Real War

War on Counterfeit/Illegal Drugs Hobbled by Same Demons as Real War

Pfizer Intelligence Uncovers $200 of Counterfeit Viagra In Manila Raid!

"Armed with a tip from pharmaceutical company Pfizer Inc., several dozen government investigators carried out a series of rapid fire raids one day last month on what were supposed to be the key suppliers of counterfeit drugs in the city [Manila]," reports the Wall Street Journal (read the story here).

"The net result of the raids, touted beforehand as likely to be one of the largest counterfeit drug busts in the city this year, was $200 worth of fake Viagra, Pfizer's erectile-dysfunction drug."

This intelligence gaffe reminds me of the Bush-era Iraqi weapons of mass destruction intelligence gaffe that propelled us to war in Iraq. I'm wondering if the "war on counterfeit drugs" is similarly based on faulty intelligence?

Another similarity between these two types of war is the unbridled optimism expressed by those in charge. "I think we are making a dent in the problem, but it's a slow process," said Scott Davis, senior director for global security in the Asia Pacific for Pfizer and a former special agent for U.S. Customs. Smells or sounds like victory, but it's no where near actual victory.

Here's yet another analogy: the war on counterfeit (or illegal) drugs seems to be as hobbled by rampant corruption of officials as is the war in Afganistan (or Iraq). In the case of the Manila raid, an owner of a couple of the target warehouses "bragged that he knew the NBI's [the Philippine's National Bureau of Investigation; i.e., the country's FBI] lead investigator on the counterfeit drug case and the deputy director who authorized the raid." After the raid turned up practically nothing, "the owner and the government agents walked a block away to lunch at Maxim's Tea House, a Chinese restaurant, according to people close to the investigation." That lunch probably cost more than $200!

It was interesting that the raiders found what they thought was counterfeit Cialis -- an ED drug marketed by Eli Lilly. Unfortunately, they did not have a search warrant for that illegal product, so no one was arrested.

It appears that Pfizer and Lilly did not share their intelligence data in this case, otherwise the NBI could have had a more inclusive search warrant.

This begs the question: Is the drug industry working together as allies in the war on counterfeit/illegal drugs? Are they sharing intelligence? Or is this also "proprietary" information that each company wants to keep close to its vest?

Pfizer "Clinical Trial in a Box" Failure: The Dead Rat Comes Home to Roost

Pfizer "Clinical Trial in a Box" Failure: The Dead Rat Comes Home to Roost

After Years of Telling Consumers Not to Trust the Internet, Pfizer Discovers that It Cannot Convince Patients to Participate in Internet-based Clinical Trials. Duh!

As reported on Pharmalot (here): "Last year, Pfizer announced plans to run the first clinical trial to allow patients to participate from home by using computers and smartphones instead of going to a clinic or doctor’s office. The idea was to create a model for saving money that will rely on personal technology to more easily recruit patients and monitor their progress. Known as a ‘clinical trial in a box,’ the study is testing the Detrol overactive bladder drug in 10 states and gained an FDA blessing. However, Pfizer ran into some snags winning over patients."

Craig Lipset, Head of Clinical Innovation at Pfizer, explained it this way: "I think some of the staunch advocates for using online and social media for recruitment are still reticent to claim silver bullet status and not use conventional channels in parallel. In terms of health literacy, the patient population is largely unaware of clinical trials and participation. You’re going in at a level where there’s still a lot of basic learning needed for individuals to make informed decisions about whether to participate. And doing that without an interaction with a healthcare provider is a challenge."

I wouldn't say there's a lack of "health literacy" regarding decisions to participate, but more lack of credible information and TRUST, which is what Lipset is talking about in the last two sentences quoted above.

As Lipset admits later on in the interview with Pharmalot:

"In a world where we’ve been telling people not to trust (web) sites online and then to ask them to do everything online is still a challenge. A very important takeaway is that online is great, but make sure these folks know they’re not alone and have a sense of contact that they need… The twist here was to go from awareness to randomized participant entirely online, and this is where ensuring some human contact as well as an optimized online process have proven extremely important."

Is this a case of the "dead rat" coming home to roost? See "Was a Rat Harmed in the Filming of This Pfizer Commercial?"

The Fake Avastin Supply Chain: China, Syria, Denmark, Switzerland, UK, US, Doctors

The Fake Avastin Supply Chain: China, Syria, Denmark, Switzerland, UK, US, Doctors

Authorities investigating the importation of low-cost foreign pharmaceuticals into the U.S. have identified a supply chain that may have allowed fake cancer drugs to reach U.S. clinics, according to investigators and documents reviewed by The Wall Street Journal (see "Doctors, Drug Distributors Tied to Imports of Fake Avastin").

"In the case of the fake Avastin, its global route isn't yet clear, but what is known illustrates the circuitous path that pharmaceuticals can take before reaching consumers. Wherever the counterfeit Avastin was manufactured—possibly China—investigators are examining a zigzagging route that may have taken the product through Turkey and Egypt before it was sold to Swiss and Danish wholesalers and then to Mr. Haughton's U.K. wholesaler, River East Supplies Ltd., according to pharmaceutical-industry and law-enforcement officials. River East then shipped the product to U.S. doctors through a Tennessee distributor, according to Mr. Haughton."

It is illegal to import drugs that are approved by regulators in other countries, but not the FDA. It is also illegal for US citizens to knowingly or unknowingly purchase such drugs. This includes the doctors and clinics at the end of the chain who purchased the Avastin at below market prices ($1995 vs $2400 for a 400-milligram vial).

"Buying foreign-sourced drugs that don't meet FDA approval can carry criminal penalties for doctors who purchase them and then bill Medicare. Penalties can apply even to doctors who weren't aware the drugs were foreign."

It is even MORE illegal -- ie, immoral -- to purchase FAKE, counterfeit drugs such as the Avastin in question, which contained starch, salt, cleaning solvents and other chemicals and none of the drug's active ingredient, bevacizumab, according to Roche.

Here's my view of the Fake Avastin Supply Chain (sorry, but I couldn't fit all the complicit distributors in the image; eg, I left out Switzerland):

WHOOPS! I forgot the last element of the supply chain, the VICTIM, aka PATIENT!

Is Pharma Part of Problem or Solution to Current State of US Economy?

Is Pharma Part of Problem or Solution to Current State of US Economy?

When Americans were asked "Thinking about the role each of the following sectors played in the current state of the American economy, do you think each of the following sectors is a part of the problem, a part of the solution, or are you unsure?," only 15% said the pharmaceutical industry was part of the solution, according to the 2012 Harris Poll Annual RQ survey. 50% said the industry was part of the problem (see chart below):

According to Harris, that puts the drug industry on the cusp of being a "malefactor" - an industry that Americans blames for economic woes. You can find the complete Harris report here.

Meanwhile, PhRMA, the industry's trade association in the U.S., continues to churn out press releases that warns Americans that if the government passes such-and-such law or over-regulates such-and-such activity of the pharmaceutical industry, it will result in the loss of thousands, nay millions!, of American jobs.

For example, in a response to the President's Fiscal Year 2013 Budget, PhRMA stated "America's biopharmaceutical industry is a key driver of economic growth; the President's proposed budget would weaken our ability to innovate and create jobs. This is not an investment in America's future and these proposals should not be considered" (see "PhRMA Statement on the President's Fiscal Year 2013 Budget").

Of course, the drug industry can be both part of the solution and part of the problem. It depends on whose problem/solution you are talking about.

It's part of the solution for white collar workers who work in the U.S. pharma industry, have Rx medical coverage, and can afford prescription drug co-pays. Blue-collar workers and retired folk who depend more on government "safety nets," however, may see  high drug prices and the drug industry's antipathy toward Medicare rebates as part of the problem. The latter are not among the typical U.S. pharma work force since the drug industry is shipping more and more blue-collar manufacturing jobs overseas to countries like China.

Not only does this NOT support jobs in the U.S., it also endangers our drug supply.

In a story about counterfeit Avastin in the U.S., the link between overseas drug manufacturing and counterfeit or tainted drugs in the U.S. was suggested: "Most Americans don't question the integrity of the drugs they rely on. They view drug counterfeiting, if they are aware of it at all, as a problem for developing countries. But the latest incident, which follows the appearance of other fake drugs in the U.S.—including counterfeits of the weight-loss treatment Alli and the influenza treatment Tamiflu—suggests it is a growing risk, especially as more medicines and drug ingredients sold in the U.S. are made overseas [my emphasis; see "Roche warns of fake cancer drug in US"). For more on this, see "Unsafe Drugs: Is It Counterfeiters or the Supply Chain That's the Problem?"

Is Pharma Part of the Problem or Solution to America's Economic Woes?
	Solution
	Problem
	Both, as you say
	Unsure

Pfizer & PhRMA Lobby in Support of SOPA

Pfizer & PhRMA Lobby in Support of SOPA

Steve Jobs once said that he'd rather be a "pirate" than join the navy. What he meant was you must think out of the box to innovate. But the world's "innovative" drug industry is the "navy" as far as lobbying in support of the "Stop Online Piracy Act" goes.

The legislation's short title is SOPA (H. R. 3261; find it here). There are several anti-SOPA Facebook pages and at least one called "Boycott SOPA (the companies lobbying for it)." You can get the official list of companies and organizations lobbying in favor of the bill here. Pfizer and PhRMA are on that list. Why? See below.

Many technology companies and web sites have organized a day of protest (today) against this bill and the companion "PIPA" bill ("Preventing Real Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011" or the "PROTECT IP Act of 2011"; find it here). Protesting companies include Google, which has put a censorship bar across its log, and Wikipedia, which has shut down totally today.

Here's some background as published today in the New York Times (here):

The bills in Congress, pushed by Hollywood studios and other big media companies, target websites that let users download pirated movies, TV shows, music and other material in violation of U.S. copyright law. Most of these sites are outside of the United States, but the legislation would give the Justice Department and private companies tools to block them from American consumers. 

For example, Google could be forced to drop an offending site from its search engine results. Or the government could go to court to stop a U.S. company that facilitates online payments to a suspected infringing site. Internet companies say they have neither the time nor the resources to monitor every link on a website or post by a user.

Google, Facebook, eBay and other new media companies also object to rogue sites, but they have repeatedly said the Stop Online Piracy Act, or SOPA, in the House of Representatives goes too far, hurting investment, innovation and the open nature of the Internet. 

Why do Pfizer and PhRMA support these bills? Simple. They believe it is necessary to prevent "counterfeit" medicines from being sold to US consumers by companies outside the US. At least that's why I think they are supporting these bills. I don't find any press releases or blog posts about it on Pfizer's or PhRMA's site. Perhaps they will respond to this post and tell us in their own words why?

If the industry needs help from the government to prevent counterfeit medicines from reaching US consumers, why not support specific laws for that purpose instead of this legislation that potentially can be used to limit the rights without due process of many online publishers -- who do not have anything to do with counterfeit medicines?

UPDATE (Jan 19, 2012): AstraZeneca Backs Counterfeit Drug Legislation

As if AZ heard what I said about pharma sponsoring more specific anti-drug counterfeiting laws, I just learned that's exactly what AZ is doing. From the AZ Health Connections Blog:

AstraZeneca sent a letter to members of Congress today to express support for legislation that would increase penalties for those convicted of counterfeiting prescription medicines. The letters sent to bill sponsors Rep. Patrick Meehan, Sen. Patrick Leahy, Sen. Chuck Grassley and Rep. Linda Sanchez note that the issue of counterfeit medicines is particularly serious via “Internet pharmacies”:

While the total incidence of counterfeit medicines sold in "brick and mortar" pharmacies in the U.S. is estimated to be less than 1 percent of the total market value, the World Health Organization estimates that over 50 percent of medicines purchased from Internet sites without a physical address are counterfeit. 

You can see the World Health Organization fact sheet on the issue here.

The letter concludes:

 Although the trafficking of counterfeit drugs is currently illegal in the United States, the penalties for such activity are the same for the trafficking of other products. The Counterfeit Drug Penalty Enforcement Act would significantly and meaningfully increase penalties for the trafficking of counterfeit drugs to reflect the severity of the crime and the harm to the public. The proposed sanctions and sentencing guidelines would serve as powerful deterrents to pharmaceutical counterfeiting, greatly benefitting patient safety and health. 

 Additional details on the bill can be found here.

"You Never Had Coffee Like This Before!": FDA Wants to Keep It That Way

"You Never Had Coffee Like This Before!": FDA Wants to Keep It That Way

FDA is warning consumers not to use "Magic Power Coffee," an instant coffee product marketed as a dietary supplement for sexual enhancement. FDA says Magic Power Coffee contains the drug ingredient hydroxythiohomosildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. The Website is shown below:

If it weren't for this FDA warning I may never have HEARD of Magic Power Coffee, much less had it. It looks delicious and could solve two of my biggest problems: staying alert AND staying erect! I almost forgot to mention that Magic Power Coffee can also make me rich if I participate in an online multi-level marketing scheme! Wow! I might sign up even if all I get out of it is FREE Magic Power Coffee!

This is only one of several products sold over the Internet containing a Viagra-like substance that the FDA has warned consumers about. Frankly, none of the other products even tempted me. One other such product was "Stud Capsule For Men," which the FDA found to be "adulterated with sildenafil" (ie, Viagra). Unlike Magic Power Coffee, a "stud capsule" does not appeal to me. For one thing, the marketing is atrocious! "Stud Capsule" as a brand name is weak -- it accurately reflects what it is supposed to achieve, but does not conjure up the type of image I'd like to be associated with. "Magic Power Coffee," on the other hand, sounds much more intriguing. Plus, it's also recommended for women!

"Imagine an incredible coffee that not only tastes great," says the Magic Coffee marketing blurb, "but magically has an effect on both men & women! With Magic Power Coffee, your 'special moments' can increase to a level you only dreamed."†

There's even a foot note on the Website reminiscent of side effect warnings seen on drug.com sites:

"Individual results may vary. These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. The information on this Website or in emails is designed for educational purposes only and is not intended to be a substitute for informed medical advice or care. Do not use this information to diagnose or treat any health problems or illnesses without consulting your doctor. Magic Power Coffee is not intended or to be used to treat any type of medical condition."

Can the FDA seize this product? I'm not sure. It contains a derivative of sildenafil, an FDA-approved drug, but it is not "counterfeit" Viagra. Also, the marketing does not make any claim that it is Viagra or has a medical use.

Of course, Magic Power Coffee could still contain other dangerous chemicals such as rat poison (for more on that, see "Was a Rat Harmed in the Filming of This Pfizer Commercial?").