Worst Practice? Senate Probes NPR Host’s Firm
16 CommentsBy Ed Silverman // November 21st, 2008 // 4:38 pm
Two days after lashing into Fred Goodwin, who hosts “The Infinite Mind” on National Public Radio, US Senator Chuck Grassley is now investigating Best Practice, a pharmaceutical consulting firm that Goodwin helped establish in the late ’90’s. Among the many services that have been offered by the firm - marketing consultations to drugmakers and the “dissemination of new off-label information.”
Doctors can prescribe a drug to treat an illness even if the FDA has not approved that use, but promotion of off-label activity is a big no-no. So in a letter sent today to Roger Meyer, who heads the firm (pictured right), Grassley wants to know more about Best Practice’s questionable practices. The Senator notes that the claims can be found on older versions of the firm’s web site (you can look here at an archived version). This is the Best Practice web site today.
How did Grassley find Best Practice? By investigating Goodwin, who we wrote about earlier. Last March, on an episode of his program, “The Infinite Mind,” which is heard on 300 NPR stations, featured three experts who discussed the controversial link between antidepressants and suicide. And all four, including Goodwin, declared that worries about the drugs have been overblown.
As it turns out, Goodwin also had undisclosed ties to drugmakers. Since 2000, for instance, Glaxo paid Goodwin more than $1.2 million in speaking fees and over $100,000 in expenses. And Glaxo markets the Paxil antidepressant, which UK regulators determined that the drugmaker had been aware since 1998 that its pill was associated with a higher risk of suicidal behavior in adolescents. NPR is embarassed and angry by all this and yanked the program from its satellite service (here is the back story, complete with a chart and a link to Grassley’s comments in the Congressional Record).
Anonymous
A Republican exposing big business interests? Say it ain’t so?
NPR I guess overlooked his credentials?
laurie
“And all four, including Goodwin, declared that worries about the drugs have been overblown”
And yet, they still sleep well at night.
Hello
The consulting fees etc. are ridiculous. But the claim about dissemination of off-label information is absurd. What the web site refers to is helping companies evaluate the regulatory environment relating to the dissemination of off-label information. There are rules, regulations and court cases about dissemination of such information. In the Washington Legal Foundation case, the FDA was enjoined by a federal court for trying to stop companies from disseminating truthful, bona fide scientific literature about such uses as a violation of the first amendment. Ultimately the injunction was vacated when the FDA told the court it would not use such pratices “alone” to prosecute companies. This resolved the immediate issue but left open that companies could be prosecuted for this “plus” other off label activity. So it is a complicated legal and regulatory area and one on which companies often look to consultants. The would be better served however by looking to their lawyers. Even so, the claim that this little wording on the web site meant this company was offering to help companies promote off label uses is a huge stretch. Even this article’s description of the web site as offering this service is inaccurate and misleading - look at the web site itself and you will see that it is offering consulting services about the regulatory environment relating to this issue. PS: I have nothing to do with this company or any of its clients.
Hello Who?
Very good, now no pizza or chinese, and call us for the order a day ahead. The doctor is only able to sign for samples, sorry!
Salmon
What’s interesting is the table Ed provides on the payments from Glaxo.
The table is labeled as generated by Glaxo itself.
Down under payments for Lamictal for 2007 it indicates that it includes honoraria for discussing the use of Lamictal for UNIPOLAR DEPRESSION. Lamictal has never been approved for treating unipolar depression, (check the labeling on the FDA website). Consquently, it appears we have proof that Glaxo knew they were paying for off-label promotion of Lamictal, which is an incredibly dangerous drug.
Thanks Ed, I’ll remember I saw it first at Pharmalot.
Salmon
Salmon
Hello,
Actually this company has links to it’s treatment recommendations at websites for supposed patient advocacy organizations, i.e. NAMI, under both professional and patient education/information.
Salmon
Parent
By the way a NAMI chapter which had links to Best Practices is in Maryland and congressional Representative Chris Van Hollen who represents many FDA employees was/is on the board.
One of the things that Representative Van Hollen has repeatedly pointed to in his legislative career in the Maryland Senate is that he repeatedly pushed for the forced psychiatric medication of patients, which includes forcibly medicating children.
Representative Van Hollen is currently Chairman of the Democratic Congressional Campaign Committee and serves on the Oversight and Government Reform committee which oversees FDA.
Prior to running for Congress Representative Van Hollen was in private practice in a lobbying firm that represented many pharmaceutical companies. If you look at the source of his money much of it also appears to be from his ex-associates, and he appears to be building a war chest to run for Senator Mikulski’s seat when she retires and to replace her on the Senate Health Education Labor and Pensions committee.
Ed Silverman
Hello Hello,
Just to clarify, you wrote: “Even this article’s description of the web site as offering this service is inaccurate and misleading.”
I wasn’t the one chose to describe the site in this way. I was reporting Grassley’s description - two different things.
Regards
ed
grassleyrocks
“dissemination of new “off label” information”
They all come tumbling down. Go Grassley Go!
The Caped Crusader
Simply put this is appalling. A new avenue for their evil ways? I suspect sadly it may be true.
Mike K.
This is big news. Have you taken a look at the cast of characters involved with Best Practice? This could be the biggest cache to date for Grassley: http://www.best-practice.net/about/affiliates/
zorro
Thank Goddess for Grassley. I hope Waxman will become as aggressive in tackling Big Pharma. As for Van Hollen, what a crashing disappointment, which I will immediately share with Obama’s website, change.gov.
And Salmon’s remark about the extreme danger of Lamictal is spot on - came within a hair of losing my daughter to it from suicidality. She was prescribed it for bipolar depression. Another crock from Glaxo.
Salmon
Zorro,
O where o where do I begin with Lamictal. This drug will go down as a classic of how Pharma hides toxicities and markets things.
Notice in the labeling how they talk about suicidality being inherent in bipolar illness. Well what you really need to get is the data for a head to head comparison with placebo eith the same duration of exposure, and look at the time frames and when it occurs. None of this well we continued people on Lamictal for a year, i.e. those who didn’t commit suicide in the first month when it occurs, and when we express the 10 cases on Lamictal per month we get a lower rate than the 1 case on placebo that also occurred during the first month. But we didn’t continue anybody on placebo longer than 1 month in part because it would have screwed up our normalization.
In other words 10 suicides in 100 people on Lamictal during the first month, and only 1 suicide on placebo in 100 people during the first month. Now we continue Lamictal for a year with no more suicides but we don’t continue placebo. So we get 10 suicides per 100 people years on Lamictal and 12 suicides per 100 people years on Placebo.
Now I don’t know if this is what was done with Lamictal but I do know that this has been done with several other drugs for bipolar illness.
Salmon
louis kayser
First of all i do not believe in this so called psychiatry or mental health, it is really just a bunch of unproven theories endorsed by our great society.There is a conflict of interest when a doctor gets any kind of favors from ank drug companies, but don’t just stop there. We also have conflicts of interssts from the news media, which often are paid to advertise for big pharma.Consequenty we don’t always get the bad side of the drug companies in the news.Many years ago medical and legal ineties were not allowed to advertise like they can now, somehow as a laymen i managed to survive it.
Salmon
Louis,
While I respect people’s opinions. I have to disagree with you and many others who do not believe in mental illness or in psychiatric drugs.
There is some truth there, take for example what I posted about about how drugs increase suicide and suicidality. This can only be if there is some sort of biological underpinning that the drugs are effecting. I have seen people who clearly responded to psychiatric drugs in a very good way. My problem is that when we know of problems or that other approaches might be better we hide the problems and simply push drugs that we know are ineffective or dangerous in certain situations or people just to make money.
I do not want to completely stop the use of psychiatric drugs or the practice of psychiatry. I want the truth to come out so we can do the best we can with what we do know and not be so money hungry that we destroy people and their families simply to make a buck. Even so people will still be hurt because we can’t make a totally safe drug and we can’t predict 100% who will be hurt and who will be helped. But we need to honestly address the problems and minimize the harm as best we can. Drug companies will never do this on their own and they have so completely take over all the checks and balances that I am personally very afraid. I do not know yet if we can trust the incoming administration and Congress to do anything. If not then I fear we are looking at death and maiming on a massive scale worldwide.
Salmon
Salmon
truthman30
Psychiatry is an Industry , it has nothing to do with healing those who suffer from depression or helping those with “mental illness” , it’s all about drugs and money, the sooner people get their head round that FACT, the sooner we can get rid of it…