When fanfic meets reality...

[tj_teejay]

This is almost freaky. I wrapped up a ReGenesis fan fiction recently (not beta’ed or posted yet) that’s about a flu outbreak and its connection to a (fictitious) anti-flu medication that I called Rivira (active ingredient tadalivir), and that I postulated would be a standard flu treatment like Tamiflu.

This is an excerpt from my story:

“It’s kinda hard to do this without the details. We know what the tadalivir molecule looks like, but to dig deeper, we need a closer look at the toxicity studies [the pharma company] must have done," David said.

Julia then piped up. “Yeah, good luck with that. I mean, have you ever tried getting anything from a pharma company as huge as TMK? You’d think it was a no-brainer to ask for the research, but then they have to go through all this corporate bullshit, cause first they need to run it by Corporate Communications, and there’s the Legal Department who needs to get involved, and suddenly you find yourself blocked at every corner and you end up with nothin’.”

It was Carlos who spoke next. “Correct me if I’m wrong, but aren’t pharma companies obligated to report all study results?”

“They are now,” Julia explained, “But mandatory results reporting was only enforced in 2008. Rivira was approved for treatment of influenza in 2002. If we’re lucky, there’s some publications out there. Have you checked, David?”

“There’s nothing useful.”

Julia mused, “Studies are 1.78 times more likely to be published if they are perceived as important, positive or scientifically significant. Early tox studies they might have done don’t strike me as either.”

“1.78, eh?” David said. “You really are the new Bob.”

Julia frowned in confusion. “What?”

“Never mind.”

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And then today I stumble across this, which says:

Roche Under More Pressure To Release Tamiflu Trial Data

EMA (European Medicines Agency) has already initiated infringement proceedings against Roche to investigate failures in the reporting of safety data, which includes not releasing 80,000 reports on adverse drug reactions. An open letter was also published in The Times (of London), urging pharmaceutical companies to "come clean" and release all clinical trial data on drugs that are currently used so that healthcare professionals have open access.

At least 123 clinical trials involving Tamiflu have been carried out, the Cochrane reviewers say. However, about 60% of patient data from Roche Phase 3 completed treatment trials have not yet been released. The reviewers are concerned about "the likely overstating of effectiveness and the apparent under-reporting of potentially serious adverse effects."

Last week, bmj.com asked who people thought is mainly at fault for denying access to negative clinical trial results. 569 respondents voted as follows:
• Pharma - 69%
• Regulators - 13.5%
• Legislators - 9%
The BMJ says it has plans to launch further campaigns urging more openness in clinical trial results.

Pure coincidence, but kinda cool and also a little freakish.

In other news, I dreamed about Walter Bishop this morning. I think Olivia was there too. That was even more freakish, but also kinda cool. Wish I could remember my dreams more often.