Nearly a third of the Association's $62 million budget comes from big pharma, which also showers individual practitioners with lucrative 'consultation fees'. The problem isn't that the profession lacks adequate ethics guidelines or regulations, but that some psychiatrists simply ignore the rules.

As a group, psychiatrists earn less in base salary than any other specialists, according to a nationwide survey by the Medical Group Management Association. In 2007, median compensation for psychiatrists was $198,653, less than half of the $464,420 earned by diagnostic radiologists and barely more than the $190,547 earned by doctors practicing internal medicine.

But many psychiatrists supplement this income with consulting arrangements with drug makers, traveling the country to give dinner talks about drugs to other doctors for fees generally ranging from $750 to $3,500 per event, for instance.

While data on industry consulting arrangements are sparse, state officials in Vermont reported that in the 2007 fiscal year, drug makers gave more money to psychiatrists than to doctors in any other specialty. Eleven psychiatrists in the state received an average of $56,944 each. Data from Minnesota, among the few other states to collect such information, show a similar trend.

In both states, individual psychiatrists are not top earners, but consulting arrangements are so common that their total tops all others. The worry is that this money may subtly alter psychiatrists’ choices of which drugs to prescribe.

An analysis of Minnesota data by The New York Times last year found that on average, psychiatrists who received at least $5,000 from makers of newer-generation antipsychotic drugs appear to have written three times as many prescriptions to children for the drugs as psychiatrists who received less money or none. The drugs are not approved for most uses in children, who appear to be especially susceptible to the side effects, including rapid weight gain.

A psychiatrist's office is a "safe space," where it's ok to ask any question, including: "have you received any compensation from any drug company?"

Psychiatric Group Faces Scrutiny Over Drug Industry Ties [NYT]
(Photo: Getty)

"Glaxo Says Wine May Fight Aging " [New York Times]
(Photos: Getty)

The Ortho patch releases high levels of estrogen and can cause problems for some patients, but J&J says it's the FDA's fault for not requiring a label sooner:

The F.D.A. did not warn the public of the potential risks until November 2005 — six years after the company's own study showed the high estrogen releases. At that point, the product's label was changed, and prescriptions fell 80 percent, to 187,000 by last February from 900,000 in March 2004.

Gloria Vanderham, a Johnson & Johnson spokeswoman, said the company acted responsibly.

"We have regularly disclosed data to the F.D.A., the medical community and the public in a timely manner," Ms. Vanderham said. "Ortho Evra is a safe and effective birth control option for women when used according to the labeling."

But Janet Abaray, a plaintiff's lawyer from Cincinnati, said that Johnson & Johnson took advantage of an agency overwhelmed by its many responsibilities.

"Johnson & Johnson knew that F.D.A. does not have the funding or the manpower to police drug companies," Ms. Abaray said.

According to PAL:

Medicare Part B recipients, health plans and individuals who paid for these drugs but were not on Medicare will be eligible to receive payments from this settlement once the Court finally approves it. The following types of individuals and entities will be eligible:

• Patients on Medicare Part B who paid a percentage (i.e. not a fixed copayment, but 10%, 20%, etc.) of the cost of one of the drugs in the case, taken between Jan. 1, 1991 and Jan. 1, 2005.
• Health Plans and other Third Party Payors who paid all or part of a Medicare Part B recipient's percentage co-insurance for one of the drugs.
• Individuals not on Medicare Part B who paid all or part (a percentange) of the cost of one of the drugs taken between Jan 1, 1991 and March 1, 2008.
• Health plans and other Third Party Payors who paid all or part of the cost of one of the drugs taken by an individual not on Medicare part B between Jan 1, 1991 and March 1, 2008.

"11 drug companies settlement AWP allegations for $125 Million" [Prescription Access Litigation]
(Photo: Getty)

Enbrel is a redonkulously expensive injectable drug that "has an annual cost of about $16,000 for a psoriasis patient."

"Amgen salespeople allege improper Enbrel promotion" [Reuters]

From Reuters (emphasis ours)

A U.S. House of Representatives committee said on Monday it was probing Pfizer Inc (PFE.N: Quote, Profile, Research) advertisements that feature heart specialist Robert Jarvik pitching its blockbuster cholesterol drug Lipitor.

Democrats on the House Energy & Commerce Committee said they were worried the widely seen commercials may mislead consumers. The probe is part of an investigation into celebrity endorsements of prescription medications, the lawmakers said.

"We are concerned that consumers may misinterpret the health claims of a prescription drug promoted in a direct-to-consumer advertisement utilizing a celebrity physician," top committee Democrats said in a letter to Pfizer.

The letter also said the lawmakers were "concerned that Dr. Jarvik's qualifications may be misinterpreted in this advertisement campaign given that he may not be a practicing physician with a valid license in any state."

NBC's science guru Robert Bazell wrote last year that while Jarvik is an M.D., he doesn't have "the strongest credentials." His grades as an undergrad at Syracuse University weren't good enough for U.S. med school, so he attended the University of Bologna in Italy, leaving after two years. In 1976, Jarvik graduated from the University of Utah's med school, but he never did an internship or practiced medicine, Bazell wrote.

Dr. Jarvik is a respected health care professional and heart expert. Dr. Jarvik, inventor of the Jarvik artificial heart, knows how imperative it is for patients to do everything they can to keep their heart working well. Furthermore, the advertising advises consumers to speak to their physicians about their heart health. The communication in the advertising helps educate consumers that it is important to keep the heart healthy including, if necessary, using medications that have been proven to maintain heart health.

Congress to Pfizer: Why is Robert Jarvik the Lipitor Man? [WSJ Health Blog]
U.S. House panel says probing Pfizer Lipitor ads [Reuters]

One of strongest claims Pfizer is making is that patients who switch have a higher risk of death, but the in-house study they cite is being criticized by doctors:

But independent researchers say that limitations in the study, which was conducted by Pfizer's own researchers, gives it little predictive power about what will happen to patients who take simvastatin instead of Lipitor. And they say the study is far less important than large clinical trials that have shown simvastatin's effectiveness at reducing cholesterol.

Of course, your doctor will know better than a blog whether you should switch:

For patients with extremely high cholesterol, Lipitor may be a better choice. An 80-milligram daily dose of Lipitor, the top dose, can reduce cholesterol by up to 60 percent, compared with about 50 percent for an 80-milligram dose of simvastatin, also the top dose."

Lilly has spent $1.2 billion since 2004 to settle lawsuits from 28,500 people who claimed they developed diabetes or heart problems after taking the drug, although Lilly says that Zyprexa has never been proven to cause diabetes. At least 1,200 more lawsuits are still pending.

"Lilly Adds Label Warnings for Mental Illness Drug" [New York Times]

• Issue mandatory recalls;
• Limit food imports to ports clustered near FDA inspection labs;
• Require a country of origin labels for food, drugs and medical devices;
• Subject exporters to a strict certification program administered by the Department of Health and Human Services.

Start hitting refresh at 10 a.m. for up-to-the-minute coverage of overly politicized opening statements and excessively verbose questioning.
(Photo: Associated Press)

9:40: Video Link
10:07: And we're off! Chairman Dingell must be sleeping in - Frank Pallone of New Jersey has taken over his seat.

10:09: Pallone is addressing a Presidential Working Group that we already covered. Their report tells us nothing we don't know.
10:11: He's staying fair and balances. E-coli contaminations and the infamous Peanut Butter Recall of 2007 were caused by domestic producers, not foreign factories. A stronger FDA could address these recalls as well.
10:14: Nathan Deal (R-GA) is talking. Not that our site is loading, or anything like that. So we'll just write for ourselves for a bit.
10:16: Gene Green (D-TX) needs to go to media school. This guy is making all the classic mistakes: rushing through his statement, reading into the paper... we haven't seen eye contact yet. His points about Houston getting shafted by the requirements to bring imported food only into select cities have been completely lost to his poor speaking skills.
10:18: His solution: open a FDA lab in Texas. For reference, there are only thirteen labs in the U.S. One, as Green is pointing out, is located in Jefferson, Arkansas. Come on, Arkansas, get one of your reps up there to defend your pork lab.
10:20: Michael Burgess (R-TX) is going China-hunting. He worried about carbs in the '90s, but now, (cue ominous music) he worries whether his groceries will make him sick. Tear for the scared Congressman.
10:23: Someone's angry that their Subcommittee didn't get to hold a hearing. Chairman Dingell need not yield to Subcommittees. He's the Dean of the House. When he introduces a bill, he can have the full Committee hold an immediate hearing. Sorry, Congressman Burgess.
10:25: Congresswoman DeGette (D-CO) has made a sad comparison. People are surprised that the CPSC can recall toys, but the FDA can't recall baby food. Please, don't ever hail the CPSC recall procedures as ideal, or better than something else. Just compare everything to the USDA's relatively amazing power to recall everything on demand.
10:27: Mike Ferguson thinks it's impressive that citizens trust the government to inspect food. What?
10:28: Ferguson worries about counterfeit drugs pushed by the Chinese Poison Train. "We need to examine the origin of these drugs." Pst, Congressman... they come from China!
10:29: Hey look, the tech gods have revived our site. Every time the site goes down, I look around my shoulder and expect to see Verizon man wearing an evil grin.
10:31: Dingell has risen, but not really. He's propping his head on his hand. The former Army Second Lieutenant always sounds like he's barking orders.
10:32: He has compared our inspection regime to a block of swiss cheese. We award no points for originality.
10:33: He has heard from the FDA that they will improve since he has arrived. "It is as much a bunch of hooey now as it was then."
10:34: A small user fee ($50 on food shipments, $1,000 on drug shipments,) is necessary to fund FDA inspectors, labs, etc.
10:35: "I would observe that the credo down there seems to be "Trust Us."
10:38: John Sullivan (R-OK) believes that reused chopsticks and support for the Taliban show that China is not a friend.
10:39: One clever fox from California just held their opening statement time so they could ask additional questions later. That means fireworks.
10:41: Jan Schakowsky is giving her opening statement. We still wish she bothered to show up for last week's hearing to chew out Mattel CEO Robert Eckert like she promised.
10:42: Jan also doesn't like limiting imports to certain ports, excluding ports like Chicago. What? Since when does the port of Chicago receive goods from China?
10:44: Heather Wilson (R-NM) is wearing a greenish-blue thing straight of the 1950s. Way to wear your values, Congresswoman.
10:50: Steve Buyer (R-IN) is mistaking a Congressional hearing for the first day of second grade. "In three minutes, I can't even begin to cover what I did over the summer."
10:53: "We propose giving the FDA the power to destroy fraudulent drugs coming into our postal system." Sounds more fun than it is.
10:56: Jim Matheson (D-UT) thinks the solution to the Chinese Poison Train is bipartisanship. Um, yeah. Care Bear Stare!
10:58: Marsha Blackburn (R-TN) is talking. 1.7% of goods were inspected in FY06. Not much more than FY07.
11:00: Blackburn has a few concerns, namely, everything in the bill. "I look forward to the discussion."
11:03: OMG, Congressman Buyer (R-IN,) there are fake drugs on the internet? No! It must be a lie! Damn Canadians, trying to kill us every chance they get.
11:07: Buyer is playing with drugs.
11:08: Statistically improbable phrase of the hour: flim-flam man (shady internet pharmacist.)
11:09: Our first coffee break of the morning is approaching. A vote on the floor will soon recess the Committee for a bit. Still haven't gotten to the first panel.
11:10: Why do all Members have the urge to regurgitate the bill's main points. We know the bill imposes mandatory country of origin labeling. We know it limits ports and imposes user fees. Resist the urge to tell us for the millionth time.
11:11: Coffee break. The Committee will return in about twenty minutes.

11:39: The hell with opening statements, we're going straight to the panelists.
11:40: First up, Randall Lutter, FDA Deputy Commissioner for Policy
11:43: He's also lauding the Presidential Working Group, the one that concluded inspections are a waste.
11:45: The FDA, like the CPSC, is meeting with Chinese officials to hammer out a Memorandum of Understanding. China regularly ignores MOUs with the CPSC.
11:46: "I would like to comment briefly on H.R. 3610." Isn't that why you're here, Deputy Commission?
11:48: Green wants to know how the FDA decides where to put its labs.
11:49: Lutter isn't sure, but he knows the FDA plan to consolidate labs is shelved (thanks partly to Dingell's threat to ban the consolidation in this bill.)
11:50: Green wants mobile labs sent to Texas.
11:51: The bill allows the FDA chief to issue a waiver regarding the port inspection provision. Green thinks that will result in an influx of waiver requests, but the FDA hasn't examined that part of the bill. Is that their strategy? We can't comment because we haven't read the bill?
11:53: Good catch, Mr. Deal: "Your written testimony doesn't seem to cover the legislation covered by this hearing. When will the Administration provide a written response? "
11:53: Lutter: "It looks like a matter of some weeks."
11:55: The user fee structure is based on line item. A line item is a shipment that comes in as one commodity under one part of the tariff code.
11:56: Mr Deal: "Does that mean an ethnic restaurant using lots of products would be subject to multiple user fees?" Do most ethnic restaurants import their raw ingredients from abroad? We're pretty sure that's not how it works.
11:57: The video link appears to be suffering from Mad Cow.
12:07: The video link has been restored. All rejoice.
12:10: Israel, Costa Rica, and Vanuatu have caught fake pharmacies shipping to the U.S. that claim to be Canadian.
12:12: Good news, kids. The FDA is especially concerned about leafy greens. Didn't stop us from enjoying a yummy kale and cheddar omelette this morning.
12:13: Another recess. Back in twenty.

1:01: That was not twenty minutes.
1:02: Dingell is shooting off a line of questions. Yes or no answers only.
1:04: Dingell's favorite phrase: "Please submit that to the record."
1:10: Pallone wants to know what new authority the FDA wants.
1:16: There's an active dialogue within FDA about what new powers they want, but they really don't want to share any details with the Congress.
1:18: "User fees are a double-edged sword." Yes, they cost businesses money, and they fund government activities.
1:19: We're clearly not dealing with the CPSC.
Pallone: Your resources are adequate, right?
FDA: Yes, they certainly are.
1:22: 5% of packages going into the FDA bin from FedEx and UPS are inspected.
1:23: The bin lets the Agency flag certain suspect shipments for inspection.
1:24: Detained products receive a mark. Buyer wants to know why products with a mark are continually shipped back to the U.S.
1:26: Counterfeit products that are not destroyed are returned to sender.
1:26: Buyer: Do you think that's a good policy?
FDA: We're concerned about the continued circulation of counterfeit products.
1:28: The FDA is willing to accept the power to destroy more products, providing that cost and due process are addressed by Congress. Sounds like a fun job.
1:30: DeGette is taking the opportunity to shill for her Denver lab. "They don't want to move to a centralized lab. Those people will all quit."
1:31: Degette: "When can you get back to me about when you can get back to me about the analysis?"
FDA: Sometime next week?
1:33: The FDA would accept more resources to inspect more items coming in, so long as it's part of a broader proposal.
1:34: By mid-November the FDA thinks it'll know how much more cash they need.
1:38: The certification regime will require the FDA to certify that exporting nations have the same or equal quality control measures as we have. Individual companies would be able to gain certification for individual facilities. Doesn't sound like it would address subcontractor problems similar to Mattel's.
1:41: FDA: "It's not something you can throw money at, flick a switch, and expect to be fixed."
1:45: The first panel is dismissed.

1:53: Onto the second panel, which has eschewed nameplates. Watch as we struggle to track who's who.
1:54: Former Congressman Calvin Dooley, now representing the Grocery Manufacturers Association is arguing that the problem is really quite small. Needle in a haystack small.
1:57: Surprise, surprise. They oppose a user fee. "Food safety is a public good, and should paid for out of the general fund."
2:00: Dooley is making a terrible point about how groceries would have to pay two separate user fees for two similar products. He holds up two boxes of vegetarian chile made by two different manufacturers. According to Dooley, the user fees on those two boxes would cost $100, but you don't import one box. You import a crate, a shipping container with a few hundred or a thousand boxes. So it's not $50 per box, it ends up being $0.05 per box.
2:04: The Food Marketing Institute, of course, opposes user fees as well.
2:07: Pallone tells FMI to wrap it up. Dooley zoomed past his time limit, which is ok because he's a former Congressman.
2:08: Another recess.

2:50: Oh, they bothered to return. How kind of them.
2:53: The Center for Science in the Public Interest, one of our favorite advocacy groups, is worried that the user fees will end up being a side show that distracts from other issues. That sounds about right, but might be intentional. It's the old Thomas Crown two-step: "...make a lot of noise over there, so over here in this room you can take 100-million off the wall and waltz right out the front door. Oh, that's good."
2:54: Big Pharma is talking, but in all honesty, we don't feel compelled to repeat their bleatings here. Feel free to get a cup of coffee and we'll let you know when Members are ready to question the other panelists.
3:16: Pallone asked everyone to defend their opposition to user fees. Upon hearing their responses, he quipped: sounds like the previous objections we have heard, but we did it anyway because we weren't sure where they money would come from.
3:23: More questions for Big Pharma. Suffice it to say, the FDA is under tremendous pressure to combat counterfeit drugs.
3:30: Matheson is making an excellent comparison between food safety and toy safety. Both require improving oversight over supply chains and the imposition of some inspection regime, either from the government or the private sector that can assure the quality and safety of goods destined for our shores.
3:38: The hearing is adjourned.

Since the study was published, Consumer Reports has come out in favor of older drugs:

Diabetes drugs received wide attention last spring when research found a possible link between rosiglitazone (Avandia) and a higher risk of heart attacks. While those risks remain unclear, the CR Best Buy Drug report cites other reasons that rosiglitazone and the related drug pioglitazone (Actos) are not wise first choices for most people with diabetes, including their higher risk of heart failure compared with other diabetes drugs.

The FDA claims that they can't pull the drug because the research is "inadequate". According to the Today show the drug pulls in about $3.2 billion in sales per year for its manufacturer, GlaxoSmithKline.

GlaxsoSmithKline's representative claimed that the drug couldn't be pulled from the market because "it's not like there's a risk-free alternative here." Risk-free. No. Comparable effectiveness with potentially less risk? Consumer Reports would say there is.

PREVIOUSLY: Consumer Reports: Older Drugs Better For Those With Type-2 Diabetes
FDA Knew About Potentially Lethal Diabetes Drug Since Last August, Said Nothing