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?

EU's EMA Plans to Open Up Proprietary Drug Trial Data to Outside Investigators

European Medicines Agency (EMA) -- the European drug regulator -- "is opening its data vaults to systematic scrutiny in a move that will let independent researchers trawl through millions of pages of clinical trial information," according to Reuters news (here).

This is big news depending on how EMA makes these large data sets available to outside investigators and which investigators are granted access. Reuters reports that the agency will host a conference in November to determine who has access to what and how fast. As I always said of the FDA, if an agency wants to delay something, its best bet is to hold a meeting to discuss it or sponsor research to study it.

The drug industry has long argued that the clinical data it presents to the FDA and other regulators as part of the drug approval process is proprietary -- ie, closely guarded trade secrets. But critics contend that important safety data about drugs is hidden from outside investigators and the data is critical for maintaining public health.

"It will make a huge difference to public health," said Peter Gotzsche, director of the nonprofit Nordic Cochrane Centre in Denmark, which carries out systematic healthcare reviews. "The pharmaceutical industry routinely exaggerates the benefits of its drugs and plays down the harms or hides them. By getting access to material held by drug regulators we may discover that many drugs are less effective than we thought they were and also more harmful."

In 2011, Gotzsche wrote paper titled "Why we need easy access to all data from all clinical trials and how to accomplish it." In it, he said "Calls for data sharing have mostly been restricted to publicly-funded research, but I argue that the distinction between publicly-funded and industry-funded research is an artificial and irrelevant one, as the interests of the patients must override commercial interests" (find the full text here: "Call for Easy Access to ALL Clinical Trial Data").

A case in point is Vioxx, whose harmful side effects once were secrets known only to Merck and the FDA.

"Europe used to be behind the FDA in terms of openness and transparency but now Europe is ahead," Gotzsche said. Will the FDA ever follow EMA's lead?

I doubt it. FDA has been very gun shy of the pharmaceutical industry, which pays over 60% of the agency's budget for approving drugs. Also, the drug industry has no qualms about taking the FDA to court to defend itself. Usually, the FDA is sued by pharma for limiting the industry's First Amendment right to free and open speech. In this case, however, the industry would argue that FDA has no right itself to "speak" freely about clinical data provided to it by drug companies.

UPDATE (7/16/2012): While the EU plans to provide access to "confidential" clinical trial data, the FDA is prohibited by LAW to do so. The Wall Street Journal reports that the FDA is monitoring some of its own employees who are suspected of leaking confidential medical device data to the press (read about this here).