NOT THE BEST WEEK FOR FDA: SPYING ON SCIENTISTS, WEIGHT-LOSS DRUGS, HIV PREVENTION, ENDOCRINE DISRUPTER BPA, MYELOMA AND BREAST CANCER DRUGS. It seems to be FDA week, but not really in a good way. A moderately horrifying New York Times examination of FDA spying on its scientists (and science journalists) was followed by a flurry of announcements from the Food and Drug Administration itself that might, in other times, have done something to make the agency look better.
FDA approved headline-grabbing drugs, one for reducing obesity and another to prevent HIV infection, a first. I couldn't help but wonder if the timing of those announcements was intended partly as misdirection, a try at burying news about the scary extent of FDA espionage under other news intended to show that the agency has our best interests at heart. This is, of course, mere speculation, but it was strengthened when FDA also issued a ban on the endocrine disrupter bisphenol A in baby bottles and sippy cups.
Which news was spoiled somewhat when reporters pointed out that BPA is not an ingredient in baby bottles and sippy cups, as Deb Blum noted at the Knight Science Journalism Tracker.
ABOUT FDA ESPIONAGE. FDA scientists had for years complained to the agency that approved cancer-screening devices released excessive radiation. Having gotten nowhere, last year they extended their complaints to Congress and others, including, apparently, science journalists. Then the scientists realized that the agency has monitored their emails and filed suit last year.
The Washington Post first revealed the spying early this year. A particularly delicious aspect of this tale is that the recent explosion of details about the extent of FDA espionage recounted by the Times came to light because an FDA contractor accidentally posted some 80,000 pages of this information on a public web site. It has now been removed, of course, but it is comforting to know that misbehavior can sometimes find its way into public view thanks to always-reliable human incompetence.
Find a recap of the Times's story at 80Beats. At the Nature Newsblog, Meredith Wadman continues the tale, including epistolary exchanges of fire between US Senator Charles Grassley and FDA officials. It contains a link to a selection of documents that had been posted publicly but are now disappeared from the contractor's site.
At In the Pipeline, pharmacologist Derek Lowe noted that
The FDA is insisting that these actions had nothing to do with rooting out whistleblowers or tracking down critics of its regulatory decisions. Not at all — they were just making sure that no one was leaking proprietary documents. The rooting out of whistleblowers and identification of critics, those were just side effects. Not everyone is buying that explanation...
For example, the Association of Health Care Journalists is protesting the spying in part because it included FDA scientists' communications with journalists. At the AHCJ blog Covering Health, Pia Christensen reported that
The letter goes on to request that the agency notify all reporters whose communications were intercepted and conduct an audit of all HHS divisions to find out how widespread the monitoring is.
NASW is sending a similar complaint to Health and Human Services Secretary Kathleen Sibelius. Do you suppose there is any chance at all that reporters will indeed be notified — and, crucially, whether we will find out that other HHS departments are being spied upon as well?
I have no idea whether FDA's other activities this week were in fact counterpunches designed partly to put the agency in a favorable light. But if that was the intention, whether its actions made FDA look good is at best debatable.
POSSIBLE COUNTERPUNCH #1: THE FIRST DRUG TO PREVENT HIV INFECTION. The Times story about the FDA spying on scientists appeared Saturday. It must have been an unpleasant (and perhaps very busy) weekend for FDA folks.
On Monday the agency bounced back with big news: for the first time it approved a drug that can prevent HIV infection. The drug is Truvada, already on the market as an HIV treatment; in fact, its manufacturer says it's the most-prescribed HIV treatment, according to Monya Baker at the Nature Newsblog. But this is a new use: to prevent HIV infection in healthy people. Clinical trials have shown that it reduces the chance of infection dramatically in uninfected people who are having sex with HIV-positive partners.
But the news was at best a mixed public-relations blessing. A leading AIDS advocacy organization said it was much worse than that: A catastrophe.
That's because there's a strong potential for misuse that could lead to HIV strains developing resistance to the drug, described by Amy Dockser Marcus at the Wall Street Journal Health Blog. If HIV becomes resistant, Truvada would not only no longer be useful for prevention, it would no longer be useful for its primary job, treating the HIV-infected.
FDA is warning people not to take Truvada for prevention unless they can be near-certain that they are not already infected and are willing to undergo testing every 3 months to keep it that way. For the same reason, once they begin, people should not skip doses. But that advice is not enforceable.
Truvada costs about $13,000 per year, and it's not known whether insurers will pay for it, reports Richard Knox at NPR's Shots. That's a powerful incentive to skip doses.
POSSIBLE COUNTERPUNCH #2: THE NEW WEIGHT-LOSS DRUG. Late Tuesday the FDA approved another obesity med, the second one in a month. Both these weight-loss drugs have a fraught history at FDA, having first been rejected on grounds that their risks outweighed their benefits.
That may not have been a terribly hard judgement to make, given that the benefits of weight-loss drugs have historically been modest at best. At CardioBriefs, Larry Husten describes the new drug's potential risks — chiefly to the heart — and the clinical findings; about 65% of subjects lost at least 5% of body weight on a regimen that included low-calorie diets and exercise as well as the drug.
At the Nature Newsblog, Mark Peplow reports on the history of the two obesity drugs in his account of this week's approval of Qsymia, formerly Qnexa. He concludes
the FDA’s risk–benefit calculations on drugs such as Qsymia and Belviq [the previously approved drug] are expected to be made more explicit under a new system that should be rolled out by October 2013.
What language did pharma-namers consult to come up with Qsymia? Not English, obviously, with its rule that q be followed by u. And how does one decide how to pronounce what they came up with? USA Today says kyoo sim ee’ uh. I would have guessed quiz see' me uh, which I concede is less mellifluous, although perhaps literally more in tune with the ambiguous benefits of weight-loss drugs.
Ah, but we are not done here. Qsymia's approval was the occasion of a peculiar embargo break, wherein USA Today published a story about the approval before the approval happened, which story was then posted automagically to other Gannett papers, according to Ivan Oransky at Embargo Watch. And then quickly plucked out of the page, where later a note appeared saying the premature article had been "inadvertantly published."
It appears to have been an embargo break, although whether a formal embargo isn't clear, nor whether the embargo emanated from the manufacturer, Vivus, or the FDA. Derek Lowe (who pointed out that ABC had also posted a video about Qsymia's approval before Qsymia's approval) posted twice on this. One post implied that the fumble had affected the manufacturer's stock price but wasn't explicit about whether up or down, and I don't care enough to look it up. His second post points out that the timing makes it clear Vivus had advance information that approval was on the way. He wants to know (and so should we) how often companies get this advance information from FDA. For one thing, it increases the potential for insider trading. Embargoes, he says,
have been turning into more of a fiasco every year as well. It seems funny for the FDA to be getting into the information embargo business just as others are realizing how hard it is to make it work.
Heavens to Betsy, he sounds like a science journalist.
AND, FINALLY, THERE'S THE STRANGE BPA THING. I've already mentioned Deb Blum's account of how journalists handled the news that the endocrine disrupter BPA, which is not in baby bottles and sippy cups, would henceforth be banned from baby bottles and sippy cups. The motive seems to have been sheer public relations requested by the manufacturers of baby bottles and sippy cups.
But you should take a look also at David Ropeik's extensive post at Big Think, which points out that BPA has not been banned from other food containers. He also examines how science gets jettisoned by fear in devising policy, concluding
What marvelous ongoing lessons in risk perception this issue continues to teach. What a clarion example of how fear, environmental advocacy, media alarmism, scientific uncertainty, and economics drive the legal and policy decisions about what is safe and what is not. What a nutty, messy, potentially dangerous, decidedly UNscientific, and completely understandable process for making risk policy BPA demonstrates.
What we need is a campaign to bring back David Kessler.
UPDATED 11:37 7/21/2012 OK, it's now quite clear my rank speculation that FDA was attempting to polish its tarnished image with an outpouring of high-profile activity seemingly in the public interest was not so rank after all. Late yesterday the agency issued not just one but two more drug approvals--and, guess what, one was an accelerated approval. (HT to Elizabeth Whittington.)
The drug that got fast-tracked the myeloma drug Kyprolis. At FierceBiotech, John Carroll reported:
Onyx nailed an FDA approval today for the multiple myeloma drug Kyprolis (carfilzomib), overcoming the naysayers who were skeptical that the agency would hand out an accelerated OK for a new drug on just mid-stage data drawn from a single-arm study. And the approval opens the door to a rich payout to the investors who backed the early development of the drug...it will also likely raise expectations among other drug developers who are hoping to win quick approvals like this, where regulators will base their initial decision based on biomarker data rather than classic survival goals.
Of course, other pharmas hoping for a speeded-up approval process may not be so fortunate as to be in the pipeline at a time when FDA has a particularly desperate need to look efficient and compassionate.
A course of treatment with Kyprolis will cost an estimated $40K.
The second Friday approval was a breast-cancer drug, Afinitor. At The Inquisitor, Melissa Stusinski recapped a New York Times story.
THE HISTORY OF SCIENCE BLOGS, AND SOME HISTORICAL HYSTERIA TOO. Can't let you go without pointing you to Bora Zivkovic's long history of science blogging at his SciAm Blog Around the Clock.
On that topic he is surely an authority, having been there pretty much from the beginning. But note also that he asks for crowdsourcing on blogging topics that he knows less about, such as math, space, and psychology. He also points out, modestly, that science blogging was around in fields like those before he got into it.
And a delightful sidelight: Bora's history has mightily annoyed Watt's Up With That's Anthony Watts. Discussing blogging awards, Bora sniffed
But if the managers of the award allow bloggers who only pretend to be scientists and use seemingly-scientific language to push pseudoscience (e.g. global warming) into the Science section of the awards, then real science bloggers react with disdain, then ignore that particular award in the future. When the award is set up essentially as a popularity contest, and when such anti-science bloggers, due to hordes of followers, win such contests, then there is no real reputation linked to that victory, thus there is no need for science bloggers to expend their energies or in any way promote such awards.
This is a swipe at Watts, a climate-change denialist, as Bora later acknowledged in a tweet accusing Watts of gaming the award system. Yum, yum, yum.
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