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Today's Must Read
The system designed to keep corporate cash from secretly slipping into the hands of doctors who do highly influential medical research isn't working very well.
Even at the nation's top institutions - such as Harvard - and affecting the most vulnerable populations - children with psychiatric problems.
A front-page story in Sunday's New York Times reports that a Congressional probe found some top child psychiatrists earning more than $1 million in often undisclosed consulting fees from drug firms.
What's most troubling about the investigation is that the these individual doctors and their public advocacy for certain drugs for mentally ill children "has helped fuel an explosion in the use of powerful antipsychotic medicines in children."
Dr. [Joseph] Biederman is one of the most influential researchers in child psychiatry and is widely admired for focusing the field's attention on its most troubled young patients. Although many of his studies are small and often financed by drug makers, his work helped to fuel a controversial 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder, which is characterized by severe mood swings, and a rapid rise in the use of antipsychotic medicines in children. The Grassley investigation did not address research quality.
Biederman, who works at Harvard Medical School's department of psychiatry, received $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given congressional investigators.
While there are rules for disclosing such payments, there's virtually no enforcement of those guidelines.
"It's really been an honor system thing," said Dr. Robert Alpern, dean of Yale School of Medicine. "If somebody tells us that a pharmaceutical company pays them $80,000 a year, I don't even know how to check on that."
While the probe, led by Sen. Charles Grassley, (R-IA) is scrutinizing the system for disclosing such payments, there is no effort to examine whether these payments may have influenced the doctors' research.
As the Times notes: "The Grassley investigation did not address research quality."
Controlling for bias is especially important in such work, given that the scale is subjective, and raters often depend on reports from parents and children, several top psychiatrists said.More broadly, they said, revelations of undisclosed payments from drug makers to leading researchers are especially damaging for psychiatry.
"The price we pay for these kinds of revelations is credibility, and we just can't afford to lose any more of that in this field," said Dr. E. Fuller Torrey, executive director of the Stanley Medical Research Institute, which finances psychiatric studies. "In the area of child psychiatry in particular, we know much less than we should, and we desperately need research that is not influenced by industry money.













This is such bullshit!!
"It's really been an honor system thing," said Dr. Robert Alpern, dean of Yale School of Medicine. "If somebody tells us that a pharmaceutical company pays them $80,000 a year, I don't even know how to check on that."
This guy is running Yale--- now that is frightening. If they are required to disclose then ask for a copy of the 1099 they received. How difficult is that---make it mandatory with an automatic termination of tenure for failing to disclose.
June 9, 2008 10:24 AM | Reply | Permalink
Why not require their full tax return as verification of all external income sources? Access could be limited to appropriate staff and they wouldn't need to retain the records forever. That would uncover other indirect payments, through speaking fees, publishing royalties, etc.
June 9, 2008 11:57 AM | Reply | Permalink
Come on now, the rich rarely punish their own, particularly when it's in the field of making even more money.
June 9, 2008 11:19 AM | Reply | Permalink
Maybe they all subscribe to Bab Bush's theory of not troubling their beautiful minds with such stuff. . .
June 9, 2008 11:19 AM | Reply | Permalink
And this is precisely why corruption is a human trait not a party trait. I fiond it distasteful that a Doctor such as this who is teaching and advising on such a unique area of adolescent issues could mistake 1.6 million over 7 years as merely some sort of accounting or disclosing slip up. The reason that such a qualified person is given the opportunity to work in so many important areas and be paid nicley is because they are someone that is in a situation to be trusted. When issues like this creep up, it makes people who believe in our leaders doubt the accountability at the top of the chain. This person who should continue to do work in his field because his knowledge is something for which our society can use needs to accept responsability for his actions and set a precedent for others to follow. This is the leadership we expect!
June 9, 2008 11:34 AM | Reply | Permalink
JoshQuasimoto,
It is difficult not to agree that corruption is a human trait. However, in our two-party system only one party ideologically appeals to the electorate with promises of "shrinking government" and "allowing Americans to keep more of their own money." Being a human trait, corruption likely follows such tendencies toward deregulation and privatization, and at the expense of the public trust.
June 9, 2008 1:44 PM | Reply | Permalink
Too bad...
In the past, we could just have them sign an agreement, and if they then took the money from the companies, they could be made to reimburse the taxpayers (it was US, folks, who pay for almost ALL of these studies).
Of course, that was before fraud against the taxpayers was actually an acceptable way for important people to sustain their important station in life.
Anyone want to bet how long it takes for one of our representatives to submit a bill making these actions criminal offenses punishable by prison (not that it isn't already)?
NEVER is my bet since we really do not have anyone in Washington who actually represents the common folk anymore... IMHO
June 9, 2008 11:51 AM | Reply | Permalink
The drug lobby is POW-ER-FUl. Be very careful about what you ingest.
June 9, 2008 12:33 PM | Reply | Permalink
This is heartbreaking but not surprising.
It's one of the most important reasons for independent child advocacy orgs. Because even kids whose parents are persistent and well-educated advocates bump up against questionable diagnosis and bs recommendations. Even from doctors at Yale (speaking from personal experience).
And the most heartbreaking thing is that there are tens of thousands of LD kids who have no real advocates. They're basically thrown to the wolves.
June 9, 2008 12:36 PM | Reply | Permalink
My wife's a child psychiatrist and she has in the past accepted payments, not for research, but for speaking to groups and such. I gave her so much shit about this. She stopped, thanks be.
It takes only a couple of minutes to be corrupted by this nonsense. Decades ago, her entire med school class was invited with spouses to Eli Lilly, all expenses paid. They want to start getting them into their pockets early. I went and it was a bizarre experience.
June 9, 2008 1:20 PM | Reply | Permalink
You gotta give props to GOP Sen. Grassley for getting on this. This gives me hope that Pres. Obama will have bipartisan support in improving health care in our country.
June 9, 2008 1:20 PM | Reply | Permalink
Honor system? Well, Dean Alpern can recover the honor of Yale University School of Medicine by suspending Dr. Biederman for a year. Or permanently. Tenure doesn't excuse such behavior.
June 9, 2008 1:38 PM | Reply | Permalink
While the failure of the scientists in question to disclose industry funding is stupid, I think the leap towards actual medical corruption is a big one, and despite the Times best efforts at loading language with insinuations of conspiracy ("fuel an explosion in the use of powerful antipsychotic medicines in children") the paper failed to prove medical malfeasance or even provide any hard scientific data. I guess that's why, buried in the piece, the Times noted that "The Grassley investigation did not address research quality."
Inadvertently, that hit one of the real problems with Congressional oversight: Farmer Grassley has hitherto displayed a less-than-stellar grasp of science, statistics and medicine, and it has led to some extraordinary and presumably inadvertent statements in recent months (to the effect that most AIDS drugs and statins shouldn't be on the market as they are merely validated by surrogate endpoints instead of outcomes trials). It would be wise, not to mention just, therefore, to examine the scientific grounds for the scientists' work before demonizing them. That may be too much when political grandstanding is at stake, but is that too much to ask the paper of record?
It's worth pointing out that the Times obsession with motive and industry corruption over scientific rigor has produced a lot of unhelpful journalism: For instance, there was the Times investigation into the reckless marketing of OxyContin (deliberate misquotation of one expert source, ignorance of peer-reviewed data, reliance on DEA source and material that had been debunked by the GAO), and Avandia (even after biostatisticans had demolished the statistical reliability of Steven Nissen's study claiming an increase in heart attacks due to the diabetes drug, the Times continued to report his findings as fact, and characterize Nissen's critics as "Republicans"). Meanwhile the DEA went off on its own campaign to prosecute doctors providing pain meds, a scandal that was redressed by the Times magazine years later, and thousands of diabetics went off a last-line of defense medication.
So, mark me a skeptic of the Times reporting and Grassley's investigation, indeed, a skeptic of any reporting or investigations that don't delve into the science in a scientific manner. (And a skeptic, I hasten to add, who hasn't received any money from Pharma, directly or indirectly through his work.)
June 9, 2008 1:43 PM | Reply | Permalink
Make no mistake--there are many children and adults who are in desperate need of effective, safe psychiatric medicine to have even a reasonable semblance of a normal, functioning, productive life. The sad thing is, after all the money big pharma spends on advertising Strattera or Cymbalta or whatever the drug du jour may be, far too many of them STILL suffer side effects and only partially relieved symptoms from those drugs they can get, or can't afford access to the most effective ones. As a mental health therapist for over 15 years I have met far too many kids who just needed good nutrition, lots of exercise, behavioral modification, parents who were not exhausted from trying to make a living and teachers who were informed and had smaller classrooms to manage--not drugs. But the stuff I mentioned above is more difficult, more expensive and quite frankly, also not researched enough to be widely available. So here come the scrips.
This kind of thing is exactly why all health care, pharmaceuticals, insurance and medical research needs, at the very least, to become completely "not-for-profit" in it's focus, and heavily regulated/overseen by a science-oriented government agency (eg, NIH, once we reform the Bushification issues)
June 9, 2008 3:00 PM | Reply | Permalink
This isn't even the most egregious case of medical professionals not disclosing their ties to particular biopharma companies. Dr. Howard Scher sat on the March 2007 FDA Advisory Committee meeting on whether or not to recommend approval for the cancer vaccine Provenge for advanced prostate cancer. Dr. Scher did not disclose his financial ties to a company called Novacea, which had a rival prostate cancer treatment, nor did he disclose that he was on the board of directors of a venture capital fund called Proquest that had several million dollars invested in Novacea. The advisory panel voted 17-0 that Provenge was safe and 13-4 that it showed substantial evidence of effectiveness. Scher was one of the four votes against Provenge, and took the extraordinary step of writing a letter (which he leaked to the press) to the FDA requesting that the agency not approve Provenge.
In May 2007, the FDA denied approval. Later that month, Novacea signed a huge partnership deal with Schering to license Novacea's drug. Scher's Proquest fund then sold its Novacea shares for close to $100 million, which was something along the lines of a 2,000% profit. Later in 2007, the Novacea drug trial was stopped by the safety monitoring board because people taking Novacea's drug died at a higher rate than people taking an approved treatment.
Provenge, the cancer vaccine that Scher opposed, had a successful Phase III trial where 34% of patients in the Provenge arm of the trial survived at least three years, while only 11% of the patients in the control arm survived three years.
A little more info on Dendreon's Provenge trial can be found at the first link below, and the second link has a little more info on Dr. Scher's various financial conflicts of interest.
http://tinyurl.com/5huts7
http://tinyurl.com/587s8s
June 9, 2008 6:40 PM | Reply | Permalink
Seems Like most of the problems would go away
If Voters of the US would vote for a real change.
Nader
- or the wild one-
Ron Paul
But most will just follow,
Let me see what are choices,
1. Dem
2. Rep
3. Keep paying taxes even after reading "Free Lunch How the Wealthiest Americans Enrich Themselves at Government Expense "
How can you trust a Government.
That has leaders that can't even think for themselves "need/allow" lobbies
Can we get a IQ test requirement for the people who control the Government.
Maybe politicians are the smart ones?
Could it be that we are the stupid ones
thinking we need or are going to have to choose from the above.
June 9, 2008 7:36 PM | Reply | Permalink
I agree with Watching Us...
As long as we continue to elect the status Quo, the Status Quo will continue to do its corrupt acts. Only by firing the crooked organizations can we begin to change our direction.
I also have little faith that this will happen, however. Too few folk desire to admit they've been wrong and are willing to change... IMHO
June 9, 2008 8:03 PM | Reply | Permalink