Info & Opinion
June 26, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
Editor's Note: Through association with certain spiritual mentalists and accredited acupuncturists, the editor of ClinPage has received what he has been assured is a bonafide transcript from nine years in the future. From the year 2019, to be precise.
The transcript below purports to be the byproduct of a U.S. Freedom of Information Act (FOIA) request. It appears to document a conversation in the White House between a future President of the United States (identified as "POTUS") and a future Commissioner of the FDA. To avoid national security risks and Ray Bradbury-esque complications from interfering with future historical events, most names of individuals and companies have been removed from the transcript. It has been otherwise untouched in our editing process. Other redacted terms, chiefly profanities, were removed by federal officials sensitive to public perceptions of the agency:
FDA Commissioner Steven -[last name redacted]-, M.D.: Good afternoon, Madame President.
POTUS Nancy -[last name redacted]-: Thanks for coming in on a Saturday, Dr. -[last name redacted]-. What's the latest?
FDA Commissioner: We've confirmed 83 new deaths. 214 people in intensive care. It sounds bad. But it's half what the folks at the Lancet—
POTUS: How many cases in the U.S.?
FDA Commissioner: 80 percent of them...
POTUS: From a patch for Alzheimer's?
FDA Commissioner: Yes, ma'am.
POTUS: And today the Washington Post is saying the government doesn't know, can't know, how many cases there are. Some guy with a Twitter account is claiming the real numbers are three times higher?
FDA Commissioner: We're looking into that. I would be offended if you were sugg—
POTUS: That the agency has known about this issue for three years? Five years? My staff is saying that FDA side effect stuff comes in from doctors by fax machine—tell me that's not true. Faxes? You print out piles of faxes? Jay Leno is laughing at you, you know that?
FDA Commissioner: [inaudible reply]
POTUS: Steve? Anything? You've got multiple dictionaries, multiple forms for the same information?
FDA Commissioner: We got some numbers wrong. We were low. I take responsibility. Should I resign?
POTUS: No. But why does the CDC have some kind of spreadsheet on this crisis? Why are they telling me the original data from the company is on paper in a warehouse in France? Do you have anyone in France, Steve?
FDA Commissioner: We have three people in Paris, one of whom is tasked to this and only this full time. One person is on maternity leave. We've been having trouble reaching the third person, but it is August. It's slow there in August.
POTUS: Should I believe the CDC?
FDA Commissioner: Madame President, our good friends at the CDC were never supposed to do more than listen to their answering machines and record what county health departments tell them. The CDC has zero expertise—I'll be nice, they are in over their heads. Way over. Keep that in mind. They're the SEC of science.
POTUS: That's the pot calling the kettle black. I'm guessing FDA feels it didn't have adequate resources?
FDA Commissioner: Madame President, this agency and my predecessors have made our funding needs quite clear. I brought some documentation on that.
POTUS: One of your predecessors is in a minimum security prison, isn't he?
FDA Commissioner: Unfair. Dr. -[name redacted]- was never incarcerated. Just lost his license to practice.
POTUS: Steve, I called you in to let you know we're finally setting up another, second FDA. It's been kicked around for years. But everyone on the Hill, even people from Big Pharma states, are on board now. The lobbyists have agreed not to fight it. This is sort of like what Obama did at Interior after the BP spill in the Gulf of Mexico. I assume I have your full support?
FDA Commissioner: How are you splitting everything up?
POTUS: You keep the power to approve drugs and other stuff. The new agency gets 400 people, a federal office building in Phoenix and the power to pull everything off the market.
FDA Commissioner: Wow. When are you announcing this?
POTUS: Monday. A few talking points. We're giving the new agency's lower-level scientific staff big financial incentives for rapid product removals. There are three medical devices we're going to pull by the end of the week. Just low-hanging fruit. We're granting this new agency immediate access to every pharmacy computer and electronic prescription in the country. The privacy activists can go -[expletive redacted]- themselves. Okay? You're on board?
FDA Commissioner: Madame President? May I speak candidly?
POTUS: Can you do that in three minutes?
FDA Commissioner: Our systems are not modern. That's true. There was this drug, Vioxx...
POTUS: —yeah, my first husband took it. Good drug for him.
FDA Commissioner: After Vioxx, FDA never got all of the data about each drug in one place, one big file. Even when we tried, it was still on PDFs, and we couldn't search for the same issue across two antidepressants or three heart pills. It usually takes us a few months just to find one piece of paper. That slows us down. Guilty as charged.
POTUS: Great. Go on.
FDA Commissioner: But—Madame President, I beg you—if you split us into two agencies, it will be a mess. How should we coordinate which agency, FDA #1 or FDA #2, gets a particular piece of information? It will be like the national security agencies after 9/11. Jockeying. Preening. Bickering with no end—do you want that? Ditto for the military services. They trip over each other. Why go down that road? We do not need another agency. Take us to the woodshed. But don't do this. Please.
POTUS: Vioxx was like 20 years ago? What have you people been up to since? Jesus.
FDA Commissioner: American doctors love paper. They don't get computers. So we could really use a task force, a special blue-ribbon board or a commission. That could figure out how to use computers to harness all the information that's out there before the news media twist it around.
POTUS: What about electronic health records? Didn't we already try that? Didn't we spent $100 billion on them?
FDA Commissioner: No EHRs can talk to a) each other, b) to industry's 21 CFR Part 11 systems or c) to our systems at FDA. It was theoretically possible to hook them up years ago, but no one made it happen outside a few pilot projects. As a result, Madame President, those systems were never connected. Every EHR is a -[expletive deleted]- island. And, to top it off, EHRs are a totally different universe of software companies than the ones we deal with. We have no legal authority over them.
POTUS: [Spanish expletive deleted]
FDA Commissioner: What about banning paper?
POTUS: A law? What? No paper?
FDA Commissioner: Maybe just an executive order. A decree? Like Guantanamo? Especially with three major political parties, I'd hate to see Congress get involved. Why do it the hard way?
POTUS: How can I ban something in every hospital in the country?
FDA Commissioner: Not in every hospital. In every research project. Frame it as a penalty to the big, bad drug industry. You already fund $50 billion in NIH research. This would level the playing field. Call it a modernization effort. People will get it. Paper is bad. It's the 21st century. It's time. I am guessing you don't want to hear about the sorts of research they do in the national health systems in Europe. They're ahead of us. They have one computer for the whole country.
POTUS: If the drug companies aren't smart enough to move away from paper in 2019, why should I force them? Why can't your people issue a new reg? Isn't that your job? I need a scapegoat.
FDA Commissioner: This company has never had any major problems. This is the first. We don't think they hid anything. There was just more data that accumulated after the drug got approved. That's not illegal, Madame President. Incidentally, -[company name redacted]- is totally behind our vaccine for TSA-transmitted respiratory infections (TTRI). We won't be able to manufacture 20 percent of what we need if they pull out—
POTUS: I'll take the chance. I'm also told we can indict their CEO. Any objection?
FDA Commissioner: I know Pierre. Been to his house on the Maryland shore. We did some consulting together back in the 1990s. It would be a shame. He really didn't do anything wrong. This came at all of us out of left field.
POTUS: This isn't baseball. The lions in the stadium are hungry. We need to feed them.
FDA Commissioner: Madame President, I understand that you need to do what you need to do. FDA can certainly help Justice with the backgrounding material, on the science, if that would be helpful for a criminal case... just let us know who needs to see the paper trail.
POTUS: Thank you, Steve. I'm told FDA #2 is on it. I appreciate your help.
[end of transcript]