Tastes Like Chicken

• 11.26.2008

As we prepare to think "turkey" -- let's first talk "chicken."

As in "Chicken Little."

I share this because, having just landed in Mexico City for a conference on HTA and pharmacoeconomics, I can attest to the fact that the sky is not falling – notwithstanding a story in today’s Washington Post that the FDA is teetering on the brink.

Consider the opening paragraph:

“Shaken by a series of alarming failures, the FDA desperately needs an infusion of strong leadership, money, technology and personnel -- and perhaps a major restructuring, say former officials, members of Congress, watchdog groups and various government reports.”

First of all, the agency already has some very high caliber leadership – but a new Commissioner with vision, guts and communication skills will absolutely make things better. The FDA is a very hierarchical agency. And it’s very true that more money, personnel and technology are must haves. Particularly technology.

But folks, as Pollyanna-ish as it may sound – the agency that parlor game pundits, some of our elected officials and so-called “watchdog groups” are bemoaning as broken – is actually working pretty well considering withering media attacks, internal score-settling and general hand-wringing by people who mostly have no idea what they’re talking about.

And some who do and should know better.

I am surprised by the comments of my former colleague Bill Hubbard who is quoted in the Post as saying, "FDA is close to being at a tipping point -- the agency is hanging on by its fingertips in protecting us."

If that’s true today, then it must have been true when Bill and I were at Parklawn together. And it wasn’t true then. Bill wants the best for the agency – but tacking to the political winds is bad strategy.

"Everywhere you go, you hear the same chorus: The agency's in trouble," said David A. Kessler, who served as FDA commissioner under Presidents George H.W. Bush and Bill Clinton. "There's a general perception the agency is suffering mightily."

It’s important to read what Dr. Kessler said – that there’s a general “perception” – that’s a lot different from it being true. But minus a smart and robust communications strategy – perception becomes reality. And the FDA has been minus a smart and robust communications strategy for too long.

And then there are those with personal agendas.

"I'm afraid we're going to see more horrible things happen if we don't get our act together on this," said David Ross, who was a drug reviewer at the agency for 10 years.

Funny the article should quote David Ross – who has a chip on his shoulder the size of Gibralter. It’s kind of like asking Hillary Clinton to write a job recommendation for Monica Lewinsky. It’s also poor reporting that Ross’ conflicts weren’t noted.

Sloppy journalism and bad editing.

And then there are those who point out how well the FDA was run when they were running it:

"The agency needs to get back to using science as the basis for its decision-making," said Jane E. Henney, who ran the FDA under Clinton from 1998 to 2001.

Let’s face it -- Jane will not go down in history as one of the great FDA Commissioners. And shame on her for saying the agency isn’t using science, first, last and always as it’s decision-making compass.

The article makes one excellent point that needs to be repeated and repeated and repeated, “While the agency has received some additional money and personnel to help implement new drug safety powers, many say it is overdue for a doubling of its budget.”

That’s change we can believe in – lots of change.

And, according to Mark McClellan – already considered by many to be one of the FDA’s Hall of Fame Commissioners -- "There's broad bipartisan recognition from consumer groups and from industry that the FDA needs more resources. The most important thing is overall effective leadership that leads in a way that establishes public trust."

Amen.

And Happy Thanksgiving.

On the BMJ-Low

• 11.25.2008

Last March (March 4^th to be exact) drugwonks.com commented on the hypocritical disconnect between what medical journals were writing about medical journalism conflict-of-interest and what they were practicing (“New Realism Redefined”) -- “There seems to be a lot of "do as I say not as I do" going on these days.”

A few months later (August 25^th), Steve Usdin of BioCentury weighted in on the same topic.  His article, “Sacred vs. Profane,” began as follows:

“Medical journal editorials routinely attack the pharmaceutical industry, alleging drug companies corrupt the practice of medicine through inappropriate and overly aggressive marketing, while also criticizing doctors for allowing themselves to be influenced.  The journal publishers themselves, however, play a key role in encouraging the behaviors their editors criticize via advertising, sponsored subscriptions and the promotion of reprints of company-sponsored clinical trials.”

(It should also be noted that both JAMA and NEJM declined Usdin’s requests for interviews.)

So it comes as somewhat of a surprise (Really?  No.) that in the current edition of the British Medical Journal (19 November 2008, doi:10.1136/bmj.a2535), much of the same ground is covered – but minus any mention of the sins of medical journals!  Why does this seemingly obvious issue of transparency fail to gain any traction?  Maybe the new Chairman of Energy and Commerce will look into it?

Maybe not.

Biederman Bashing Part 2

• 11.25.2008

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.

Read More

Donate Form TEST

• 11.25.2008

Donate Form

Mr. Mrs. Miss Dr.

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1. Phone

   
   

   
   
   
   
   

2. Email

   
   

   
   
   
   

Grassley Stains

• 11.24.2008

Here's how Chuck Grassley conducts "investigations"

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 Frederick K. Goodwin, MD; Bruce Fireman, MA; Gregory E. Simon, MD; Enid M. Hunkeler, MA; Janelle Lee, MHA, DrPH; Dennis Revicki, PhD

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.

Term of Endearment

• 11.24.2008

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 U.S. economy get so caught up in tacking against biting political crosswinds? As a veteran of the regulatory wars, my argument is that the rocky seas began to roil when the position of FDA Commissioner was converted from a career position to a political position in the late 1960s. Prior to that time, the FDA chieftain was generally someone who had advanced through the ranks of the agency gaining experience and seasoning along the way. When the Commissioner’s position became Senate confirmable in the late 1980s, some believe an adverse change took place. Others believe that politics is just more contentious than ever before. Both of these notions are correct.

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 America’s health. 

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.

Quantum of Shamelessness

• 11.21.2008

More info that the New York Times left out of its story on Fred Goodwin:

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.

Read More

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.

Expert Witness

• 11.21.2008

Per today's article in the New York Times on my friend and colleague Fred Goodwin ... why was there no mention of stature in the field of psychiatry?

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.

Generic Attack on Fred Goodwin

• 11.21.2008

Fred Goodwin is one of the leading psychopharmacologists of this century. He is also a practicing psychiatrist. That is reason alone for those bent on driving down the use of medications for mental illness to target Goodwin for being paid to advise pharmaceutical companies who develop products for the treatment of such conditions. Goodwin -- who is my friend and a CMPI board member -- is a pioneer in the successful treatment of schizophrenia and manic depression. His radio show, "The Infinite Mind" covered a wide variety of subjects ranging from dreams, to aging, to depression over the 15 years he was the host.

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

Adding the Fuel of Interest to the Power of Genius

• 11.21.2008

Day II of the IFPMA Assembly offered a pastiche of pithy policy pensées.

John Lechleiter (President and CEO, Eli Lilly & Company) spoke on the urgency of making healthcare more personal. A few points from his remarks:

* “The free market hasn’t failed — it just hasn’t been given a chance to work as it should.”

* “With critics of the U.S. system pointing to Europe and other countries for reform guidance — in the past decade, nearly every European country has introduced market-oriented reforms — and has turned to the private sector in their efforts to reduce the health costs of treatments.”

* “We need to build a consumer-driven system — one that instills a sense of personal ownership … and puts the individual consumer in charge of how health care dollars are spent — through such mechanisms as health savings accounts.”

* “Transparency is the lubrication that makes consumer-driven healthcare work.”

* "We need to restructure the system so it is patient-centered … where health care providers, payers, regulators, and innovators work together to answer a single question: What is best for the individual patient?”

* “In a patient-centered system, individuals bear primary responsibility for their own health. And physicians help patients recognize incentives for healthier living … and act as agents on their behalf. In this system, providers compete on value and are measured on quality.”

* “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 U.S. employees consumer-driven options: HSA/HRA. About one-third of employees opted for a health savings account or a health reimbursement account.”

* “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 the IFPMA will commence a global communications effort on the value of IP. And while he didn’t say that IP is a human right, he came very close – pointing out all of the good that solid intellectual property right protection affords civil society. He also quoted Abraham Lincoln (a popular thing in Washington, DC these days), saying that intellectual property rights “add the fuel of interest to the passion of genius.”

Bravo.

Hassan also noted that the IFPMA is going to field a study to determine its image and level of influence in Geneva. (Note to Fred: If you have to ask …)

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 Bangladesh (yes – the one run by Nobel Laureate Muhammad Yunus). Pfizer and Grameen are developing a “micro health insurance model” along the lines of Grameen’s well-known micro-credit programs. According to Bagger, a policy might cost $20/month of which $3 would go towards pharmaceutical coverage. That’s consumer-driven healthcare LDC style – and a program that the world’s largest life sciences company should talk about publicly, proudly and often.

Ladies and Gentlemen – the frost is on the pumpkin and it’s time to get to work.