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Did Joe Biederman do anything unethical or wrong by asking Johnson and Johnson to support a research center to develop gene and imaging based diagnostics to more accurately screen for child and adolescent bipolar disorder and then use risperidone (and other drugs) to conduct open label and randomized clinical trials to establish if treatment based on new screening criteria produced better results?
Yes. Biederman should have been more transparent or more promotional about it. Because in this day and age if you don't let your enemies know what you are doing by definition you are hiding something. And if you are hiding something you are by definition conspiring to poison people (particularly children) with drugs that are "powerful" but somehow also "ineffective" and dangerous.
Should J and J not have decided to spend $6 million promoting awareness of bipolar conditions in kids, support CME with unrestricted grants and seek ideas on the appropriate way to design studies for pediatric labeling?
It should have been more open, more willing to give up control and let the science and consensus go where it might instead of letting marketing people try to micromanage.
It's the secrecy stupid. You have nothing to be afraid of. Or ashamed of. If you are transparent that will leave your enemies as the only ones skulking around, conspiring, feeding and feeding off trial attorney dough for fear and profit.
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1. He sends a letter like this one to Roger Meyer of Best Practice which is a private for profit company that receives no federal grant money. But that's beside the point since the crime is now simply conducting and publishing research on any observation of any post market benefit of any drug for mental illness in peer reviewed publications such as JAMA. Which is what Fred Goodwin and Roger Meyer did along with authors from Kaiser Permanente and Group Health of Puget Sound.
(Suicide Risk in Bipolar Disorder During Treatment With Lithium and Divalproex
JAMA. 2003;290:1467-1473.)
The subject of Grassley's investigation is the following: " A Population-based sample of 20 638 health plan members aged 14 years or older who had at least 1 outpatient diagnosis of bipolar disorder and at least 1 filled prescription for lithium, divalproex, or carbamazepine between January 1, 1994, and December 31, 2001. Follow-up for each individual began with first qualifying prescription and ended with death, disenrollment from the health plan, or end of the study period."
The results?
In both health plans, unadjusted rates were greater during treatment with divalproex than during treatment with lithium for emergency department suicide attempt (31.3 vs 10.8 per 1000 person-years; P<.001), suicide attempt resulting in hospitalization (10.5 vs 4.2 per 1000 person-years; P<.001), and suicide death (1.7 vs 0.7 per 1000 person-years; P = .04). After adjustment for age, sex, health plan, year of diagnosis, comorbid medical and psychiatric conditions, and concomitant use of other psychotropic drugs, risk of suicide death was 2.7 times higher (95% confidence interval [CI], 1.1-6.3; P = .03) during treatment with divalproex than during treatment with lithium. Corresponding hazard ratios for nonfatal attempts were 1.7 (95% CI, 1.2-2.3; P = .002) for attempts resulting in hospitalization and 1.8 (95% CI, 1.4-2.2; P<.001) for attempts diagnosed in the emergency department.
Conclusion Among patients treated for bipolar disorder, risk of suicide attempt and suicide death is lower during treatment with lithium than during treatment with divalproex.
See how dangerous this is. No wonder Pharmalot rushed to blog on the Grassley "probe"
Worst Practice? Senate Probes NPR Host’s Firm
Of course, engaging in such activities in identifying risks is ok and individuals with such information should contact Grassley's office or the Church of Scientology or both. (Something tells me that either way the one will get the info to the other.
2. How did Phamalot find out. Turns out that Grassley, well before Roger Meyer even responded to the Grassley "probe" send what his missive to to the media in advance of sending the letter to Roger Meyer as well as bloggers such as pharmalot whose blog is an oasis for the anti-psycho-pharm crowd. Pharmalot then trumpets that Best Practice is being investigated by Grassley. Did Pharmalot contact Roger Meyer or Fred Goodwin or read the JAMA article in question. Of course not. Is such behavior defamatory. To my mind it is. When I have gone over the top -- and I have - I have at least apologized or issued a retraction. We will see what happens to Pharmalot in the days ahead. Even bloggers should abide by a code of moral decency.3. But don't hold your breath. The pharmalot blog along with others will generate more mainstream media headlines and articles. And a press release from Grassley that is already to go.
Will this have a chilling effect on the publication of off-label effects of medications. Of course it will. Will that harm patients and undermine innovation. Of course. Along with the assault on any tie between industry and academia.
The hijacking of science for fear and profit continues apace.
The U. S. Food and Drug Administration prides itself on being, first and foremost, all about science. So, how did the agency that regulates upwards of 30 percent of the
When one considers the mission of FDA—to independently protect and advance the public health—it is not at all clear whether the Commissioner should be a Senate-confirmed political appointee “serving at the pleasure of the President.” I think that the American people would prefer he or she be nominated by the President for a fixed 6-year term—similar to that of the Director of the FBI. Think about it—why should the safety of food additives, the integrity of the blood and vaccine supply, and decisions on drug labeling indications (to name only a few FDA responsibilities) be considered Democratic or Republican issues? The boss of the FDA Commissioner is and should continue to be the Secretary of Health and Human Services—a politically appointed, Senate-confirmed cabinet officer. This is enough. More politics just leads to regulatory paralysis and discord—neither which protects or advances
Having had the honor to serve our country as an FDA Associate Commissioner, I can unequivocally state that the unwelcome infusion of politics into science makes an already difficult job virtually impossible. To have the job of Commissioner open and only partially filled for extended lengths of time grinds progress to a halt. Low morale, lengthy delays, and even postponements often characterize an open Commissionership. This is not acceptable.
Who becomes the next FDA Commissioner is important. But an important indication of the seriousness with which President-Elect Obama takes that post is how soon in his administration a nomination is made. Let’s hope it’s done swiftly and smartly.
For more on this, have a look at the Journal of Life Sciences.
The Times writes:
"He defended the views he expressed in many of his radio programs and said that, because he consults for so many drug makers at once, he has no particular bias."
“These companies compete with each other and cancel each other out,” he said. This view is dismissed by industry critics, who say that experts who consult widely for drug makers tend to minimize the value of non-drug or older drug treatments."Here are the facts:
Goodwin consistently studied the effects of lithium a drug that lost it's patent nearly a half century ago and continues to lecture about it's benefits as a front line treatment for manic depression.
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Goodwin also pioneered the use of light therapy to treat season affect disorder.
Meanwhile the Grassley witch hunt continues apace, now "investigating" Goodwin's private consulting business for promoting "off-label" use of lithium. Translation: Publishing an article in JAMA comparing the effect of lithium in reducing suicide among manic depressive patients to marketed products - in partnership with managed care plans and other research organizations -- is now a reason to investigate. And of course just being investigated by Grassley is a crime because taking money from any drug company for any reason at any time makes all of one's research suspect and you a criminal.
Got that?
I can hear the hatchets being sharpened. Shannon Brownlee and Jeanne Lenzer must not be far behind.
Here are (only) some of Dr. Goodwin's particulars:
* Research Professor of Psychiatry at The George Washington University and Director of the University’s Center on Neuroscience, Medical Progress, and Society;
* Former Director of the National Institute of Mental Health
This was not relevant to the story, why?
Looks like that "all the news that's fit to print" window is getting narrower all the time. Talk about a lack of fair balance and adequate provision.
Time to contact the Ombusdman.
He is being slimed by the same small-minded group that wants to savage science and replace it with a contorted combination of anger, unmedicated anecdotes and trial lawyer inspired opportunism.
Goodwin will continue to publish, lecture and research, adding value and knowledge to patients lives.
Here's the difference between Goodwin and his attackers:
Fred has helped reduced the number of suicides among the mentally ill. They have helped increase them.
They have to live with their legacy. I am sure Fred will be content with his.
Read New York Times article
Day II of the IFPMA Assembly offered a pastiche of pithy policy pensées.
* “The free market hasn’t failed — it just hasn’t been given a chance to work as it should.”
* “We must build a system that promotes universal access, not by mandate but through free-market solutions that maximize coverage and improve access.”
* “In 2007 — for the first time — we offered
* “This year, roughly two-thirds of enrolled employees — including moi — and dependents chose one of these options. By 2010, our company will offer only consumer-driven options for our active employees.”
Lechleiter’s full remarks can be found here.
In his keynote address, IFPMA President Fred Hassan (whose day job is Chairman and President of Schering-Plough), shared that
Bravo.
Hassan also noted that the IFPMA is going to field a study to determine its image and level of influence in
Rich Bagger (SVP, Worldwide Public Affairs & Policy, Pfizer) was the only speaker to consistently refer to his company as being in the “life sciences” business. Why is this so hard for everyone else to remember ?
One of Rich’s themes was “new roads to access.” And he offered a very early yet tantalizing example – Pfizer’s partnership with the Grameen Bank of
Ladies and Gentlemen – the frost is on the pumpkin and it’s time to get to work.
Tom Daschle is a terrific choice for HHS for many reasons. Most importantly, he’s a grown-up.
Daschle's sure-footed Washington savvy should pretty much shut the door on those Nabobs of Nissenism who are calling on King Steven to ascend to the FDA throne. Secretary-Presumptive Daschle knows better than to take anyone seriously who is so universally disliked among the most senior FDA staff and so generally divisive among almost everyone else.
His other role in the Obama White House, that of Health “Czar,” poses some interesting questions. Specifically, how will he approach the issue of the Part D Non-Interference Clause – which he (along with Senator Kennedy) drafted in the first place?
Yesterday, at Day II of the IFPMA Assembly, the luncheon speakers were former Senators John Breaux and Trent Lott. Neither thinks there will be a strong Congressional effort to reverse the Non-Interference Clause.
I am not as phlegmatic.
And to that point, a few things worthy of consideration:
"It is not obvious that allowing the government to negotiate with pharmaceutical companies will lead to lower prices than those achieved by private drug plans. Private plans like Kaiser or United are able to negotiate deep discounts with pharmaceutical companies precisely because of the plans' ability to say no – the ability to include some drugs and to exclude others, allowing the market to judge the resulting formulary. On the other hand, when the government negotiates, its hands are tied because there are few drugs it can exclude without facing political backlash from doctors and the Medicare population, a very influential group of voters. Neither economic theory nor historical experience suggests government price negotiation will achieve lower drug prices. Congressional Democrats need to be careful in making the logical leap from market share to bargaining power. Empowering the government to negotiate with pharmaceutical companies is not necessarily equivalent to achieving lower drug prices. In fact, neither economic theory nor historical experience suggests that will be the outcome. Members should think carefully before jumping on the bandwagon – this promise may bring just the opposite of what was ordered."
"Both the non-partisan Congressional Budget Office and Medicare actuaries have said they doubt the government could negotiate lower costs than the private sector. The theory behind Part D is that market forces and competition among drug plans, overseen by government, can achieve better results than a government-run program. The multitude of plans allows seniors to pick one that best meets their needs. Government price negotiation could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. Medicare recipients account for half of all drug prescriptions. With that kind of clout, government might try to dictate prices, not just negotiate them. This could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. The VA plan illustrates the point. It offers 1,300 drugs, compared with 4,300 available under Part D, prompting more than one-third of retired veterans to enroll in Medicare drug plans."
"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06
* The projected cost for Medicare Part D is $117 billion lower over the next decade than experts estimated just last summer. This means that over the 10-year period from 2008 to 2017, the estimated $915 billion cost of Part D fell to $798 billion.
Why? Marketplace competition.
* And, according to a study published in the Annals of Internal Medicine, the Medicare drug benefit led to a 17 percent decrease in out-of-pocket expenses, or $9 a month, for seniors who enrolled in the new Medicare Part D benefit in 2006, the first full year prescription coverage became available in the federal health insurance program for the elderly and disabled.
* And the savings amounted to an extra 14 days of medicine for those who signed up, or a 19 percent increase in prescription usage.
Can Part D be made even better? Absolutely. But this is good news worth sharing -- and not because it helps any particular partisan political agenda but because it means that more Americans -- tens of millions of more Americans -- are getting access to the medicines (largely chronic medicines) that will help them live healthier lives. And this, in no small measure, significantly reduces more drastic medical interventions -- which in turn reduces our overall national health care spending.
We shouldn’t interfere with success.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
