None of Your Business

The Associated Press ran a recent story indicating that two top FDA officials who are required by law to post their appointments had not been doing so for several years. The calendars of high-ranking officials Janet Woodcock and Steven Galson were described as "virtually empty" for a period of several years. After a congressional investigation noted the blankness of their calendars, FDA officials filled in their calendars retroactively. To nobody's surprise, their calendars included many meetings with drug industry officials as well as others. Just how blank were their calendars?

There were just three listings for Woodcock between January 1999 and December 2006, even though she occupied two positions during that time that required her meetings to be listed: director of the center for drug evaluation and research and, later, deputy commissioner for operations. Investigators found no listings for Galson, who took over the drugs office from Woodcock on a full-time basis in July 2005.

Yeah, that's pretty blank. I'm not suggesting it is entirely wrong for them to have met with drug industry officials, as that is obviously part of the job. But why cover it up? At the very least, it creates an impression that there is something to hide. Worry not, the FDA has described it as "administrative oversight." Perhaps the FDA has an intern in charge of schedules who resembles the PhRMA intern of John Mack fame.

Hat Tip: AHRP

Link-A-Thon

Good posts that warrant your attention include:

• In terms of efficacy, antidepressants + mood stabilizer = placebo + mood stabilizer in bipolar disorder according to a new study. I've not yet read it, so I'll refer you to Furious Seasons for an analysis (1, 2).
• Oh, the University of Medicine and Dentistry of New Jersey (UMDNJ). It seems like nary a week goes by without some sort of serious ethical/corruption issues rear their ugly heads. For more on the situation, check out Health Care Renewal. Maybe that's why Lilly partnered with them to create a Center of Excellence for Psychiatry?
  
• Antipsychotics linked to death in the elderly, again. Thanks for PharmaGossip for pointing this out.
• Pharmalot wonders why the FDA is patting itself on the back for protecting public health at the same time that it is performing less enforcement.
  
• John Mack basically says this blog is close to useless according to his rating scale. That hurts, Mr. Mack.
• Seroxat/Paxil is an easy target, but that doesn't mean we should stop kicking it while it's down. Fiddaman scores points with a good post on how GSK covered up its data on the drug, while Seroxat Secrets has been ablaze with posts pointing out the patently false statements made by GSK employees about Seroxat/Paxil.
  

Dimetapp or Zyprexa?

It appears that the FDA is conducting an investigation of the safety of over the counter cold medications for children. Apparently, the safety of these medications in children is largely unknown despite their widespread use in kids. There are also concerns that in overdose, these meds may be harmful or perhaps fatal.

I appreciate that the FDA is getting off its duff, but Stephany at the Soulful Sepulcher has an even better idea -- how about the FDA investigating the safety of psychiatric medications in kids? Something tells me that Zyprexa, Seroquel, and Depakote might, just maybe, have more safety issues in kids than Dimetapp or Robitussin. Hey, maybe there is a problem with the cold meds, but can we at least consider that heavy duty psych meds might also impact the health of youth? After all, meds such as the atypical antipsychotics are experiencing quite the boom in prescriptions for kids -- wouldn't we want to be sure that this boom was not leading to a corresponding increase in health problems?

FDA Testimonies on SSRIs and Suicide

You may recall the FDA's meeting on SSRI's and suicide. You can now access the presentations of the speakers, including David Healy, Robert Gibbons, Sara Bostock, Vera Sharav, Robert Valuck, and many more.

Transcripts of the meeting (part 1 and part 2) are also available. Kudos to the FDA for their willingness to post all this material online.

Hat Tip: ShrinkRap.

You GO, Graham!

David Graham is once again stepping up to the plate, saying that the FDA needs to get its act together and actually protect the safety of the public. Crazy idea, eh?

According to Reuters:

FDA scientist Dr. David Graham told a congressional hearing the drugmaker and the agency knew "for a long time" about the risk of weight gain from Zyprexa that could trigger diabetes.

"FDA did its typical dragging its feet on post-marketing safety issues," he told Reuters after the U.S. House of Representatives Energy and Commerce subcommittee hearing.

Graham did not review Zyprexa, but said that, after his 2004 public testimony criticizing the FDA's actions on Merck & Co Inc.'s (MRK.N: Quote, Profile, Research) withdrawn Vioxx painkiller, other agency staffers came to him with concerns.

Graham also said that Congress should investigate the FDA's handling of Zyprexa regarding safety concerns. Why are there so few people at the FDA who seem to care about these issues?

Hat Tip: Furious Seasons, PharmaGossip

Neuronetics Swings... AND MISSES!

Neuronetics' transcranial magnetic stimulation was rejected by the FDA's advisory panel today. For a couple of stories on the panel's discussion and recommendation, try here and here.

According to one report:

The majority of the panel—made up of an engineer, several psychiatrists and neurologists, and a statistician—had no problem with rTMS's risks. There are almost none. The biggest worry with it is that it might accidentally spark a seizure, but that did not happen even once out of the 155 patients treated. The problem was that Neuronetics couldn't prove any benefit. Treated patients got a little better, but so did those patients that underwent a sham treatment.

According to another source:

But the panel was generally unimpressed with the company's data, which showed a slight statistical advantage in depression symptoms over dummy therapy after six weeks of treatment. Several panelists expressed dismay that patients showed no improvement on some depression scales and only minor improvement on ones that showed a difference.

"The panel seems to be in consensus that the primary analysis did not establish efficacy," said Thomas Brott, the committee's chairman.

"Perhaps a reasonable person could question whether there has been an effect at all," said Brott, a neurologist from Mayo Medical School in Jacksonville, Fla.

The panel did not formally recommend to FDA whether or not the machine should be approved. But the agency scientists suggested at a public hearing that they were also uneasy with the company's results.

Ann Costello, an FDA medical reviewer, questioned whether the mixed evidence of effectiveness in Neuronetics' studies contained "any clinically relevant information."

Peter Lurie, deputy director of Public Citizen's Health Research Group, told the panel that Neuronetics did not show that its device was substantially equal to ECT, a standard that many medical devices must meet for FDA approval. He focused on the fact that patients actively treated with the machine showed mild improvement on only one of three depression scales.

"The magnitude of the finding is trivial from a clinical point of view," he said in an interview.

Maybe the FDA panel learned something from the VNS approval (here and here)?