On the BMJ-Low

11/25/2008 04:27 PM |

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.

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Biederman Bashing Part 2

11/25/2008 03:22 PM |

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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Grassley Stains

11/24/2008 04:28 PM |

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.
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Term of Endearment

11/24/2008 01:35 PM |

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.

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Quantum of Shamelessness

11/21/2008 07:36 PM |

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.
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Expert Witness

11/21/2008 06:39 PM |

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.
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Generic Attack on Fred Goodwin

11/21/2008 05:10 PM |

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
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Adding the Fuel of Interest to the Power of Genius

11/21/2008 01:45 PM |

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.

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Hello Tom. Goodbye Steve.

11/20/2008 02:37 PM |

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."

Stanford Business School's Alain Enthoven and Kyna Fong

"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 bottom line here is that Part D is a tremendous success – due in no small part to the Non-Interference Clause.  Consider:

* 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.

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Connections That Count

11/19/2008 09:36 PM |

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Of Budget Shortfalls and Snake Oil

11/19/2008 11:32 AM |

As our current financial meltdown forces state governments to consider ugly budget cutbacks, some foolish ideas often get undeserved airtime.

Specifically, drug importation.

It’s worth restating the facts.

State and local importation schemes have been dismal and politically embarrassing. Remember Illinois’ high profile “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population.

And what of Minnesota’s RxConnect? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.

And what about Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield has been out of “drugs from Canada business” since August 2006. (But that hasn’t stopped Chris Collins – a representative of CanaRX from telling some New York municipalities that, “We’re now saving over $2 million a year in Springfield, MA” (Hamptons.com Sept 30, 2008, reported by Aaron Boyd).

Shameful.

This is particularly appalling since the drugs being sent to U.S. customers from CanaRX are most certainly not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. CanaRX – by their own admission – sources their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.

PS/ The drugs CanaRX sells to Americans aren’t even legal for sale in Canada.

Oh – and by the way, such programs don’t even save any money. A study by the non-partisan federal Congressional Budget Office (CBO) study showed that importation would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the millions of dollars the FDA would need to set up a monitoring system.

We’re all in deep enough fiscal trouble.  We shouldn’t make it any worse by looking for unsafe, unsound, quick-fix solutions that make for good soundbites -- but bad public policy.
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Sachs Appeal

11/19/2008 12:19 AM |

Sorry for the late evening post, but I've been at 24th IFPMA Assembly in Washington, DC. all day.

Some highlights:

The luncheon keynoter was Jeffrey Sachs, Quetelet Professor of Sustainable Development and Professor of Health Policy and Management at Columbia University -- but he's probably better known you drugwonks out there as the Director of the Earth Institute and author of "Common Wealth" and "The End of Poverty." Most of his talk was of the usual garden-variety "more government, please" variety -- but he did say one thing worth mentioning, that although he has some serious issues with pharmaceutical patents, "lifesaving innovation would be impossible without them." Yes -- "impossible." I wonder what Jamie Love will have to say about that?

The best panel of the day featured the health ministers from Kenya and Uganda (Peter Anyang' Nyong'o and Richard Nduhuura respectively), who spoke of their nations' need for enhanced healthcare infrastructure -- and then Alessandro Banchi (Chairman, Boehringer Ingelheim) laid it it out in black and white, "The elephant in the room is the fragility of healthcare systems -- not the price of drugs." Neither of the two ministers objected.

Zhang Weibo (Director, Pharmaceutical & Biological Review, People's Republic of China), spoke on the issue of IP and TCM (Traditional Chinese Medicine) -- an issue that deserves further discussion -- and will certainly get it. (Note to Congress: Better open the fortune cookie and start thinking about DSHEA reform.)

Swati Piramal (Director of Strategic Alliances, Piramal Healthcare, Ltd, India) spoke about India's emergence as a nation of pharmacetical innovation. She said her firm has a few drugs in the pipeline that can be brought to market for under $100,000,000. That got people's attention.

More from the IFPMA Assembly tomorrow.
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Pharma's Margin Call

11/17/2008 06:35 PM |

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PS/ The faucet leaks

11/17/2008 01:33 PM |

In what he referred to as a “note on the desk” to the next Secretary of Health and Human Services, Mike Leavitt, the current inhabitant of that seat released “The Personalized Health Care Initiative.”  Personalized health care should be an "explicit goal of health care reform,'' Leavitt said.

According to the HHS website, “The Personalized Health Care Initiative will improve the safety, quality and effectiveness of healthcare for every patient in the US.  By using “genomics”, or the identification of genes and how they relate to drug treatment, personalized health care will enable medicine to be tailored to each person’s needs. Healthcare that is proactive, instead of reactive, gives the patient the opportunity to become more involved in their own wellness.”

HHS seeks to advance this Initiative through two guiding principles:

(1) Provide federal leadership supporting research addressing individual aspects of disease and disease prevention with the ultimate goal of shaping preventive and diagnostic care to match each person’s unique genetic characteristics.

(2) Create a “network of networks” to aggregate anonymous health care data to help researchers establish patterns and identify genetic “definitions” to existing diseases.

Oh well, better late than never. (The complete report can be found here.)

Hopefully there is a longer memo (perhaps with the keys to the backdoor and the security code to the secretarial washroom) on the urgent need to fund the Reagan/Udall Foundation.

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Lewis Black: Equal Opportunity Offender

11/14/2008 07:00 PM |

The great Lewis Black expounds on why politics is a renewable resource for comedians...

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NICE Birthday Wishes to Prince Charles

11/14/2008 12:31 PM |

Yesterday I had an op-ed in the Washington Examiner, “Obama, Congress Should Learn from Britain’s Healthcare Failings,” where I make the point that “NICE’s failings indicate that government is liable to misuse drug approval power, and they should arouse suspicion about the merits of additional government intervention in the healthcare market. The British government is finally giving patients and physicians the freedom they need to best combat disease. American lawmakers should follow their lead.”

But what I’d like to share with you is a comment that was posted in response to my discussion of NICE and its implications for US healthcare reform.

Here it is:

“Pitts cannot hope to cover all of the NHS's sins in a short piece. They also instruct doctors to lie to patients, informing them that life-saving treatments do not exist, when the NHS has merely decided the procedures are too pricey. It is better, in the view of the NHS, that people die rather than complain. Also, thousands die in their hospitals each year because staff cannot be bothered to wash their filthy hands. A trip to the NHS is often a death sentence, pure and simple."

And to that all I can add is, “Happy 60th Birthday, Prince Charles.”
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Health Policy Shocker: Commonwealth Survey Finds US Healthcare Worst in World Yet Again

11/13/2008 05:59 PM |

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Pearls from the Tevi Fountain

11/13/2008 12:15 PM |

Congratulations.  You’ve survived the “valley of death,” emerged from the “tar pit of safety," successfully forged the Critical Path and received FDA approval.  Mazel tov.  Now you’ve earned the privilege of fighting with CMS and a potential AHRQ comparative effectiveness review.

And it’s been ambiguity all the way down the line.

So here’s some welcome news: Tevi Troy, the HHS DepSec will host a series of conferences over the next two months to discuss how different HHS agencies can help improve the process.  And is there anyone out there who feels improvement is not required?

The first conference takes place this Friday, November 14th at HHS HQ (aka the Hubert Humphrey Building) in Washington, DC. December forums are being scheduled for the west coast and Midwest.

At this first meeting, senior officials from NIH, FDA, CMS, and AHRQ will discuss (and likely have to defend) their agencies’ roles in facilitating the development of innovative medical technologies. 

Topics include:
          
* The role of basic and clinical research conducted and supported by the NIH in the development of new products;

* FDA's efforts to use state-of-the-art science in support of medical product development, as well as to promote consistency and efficiency in medical product review;

* CMS’ perspective on the challenges innovators face in current reimbursement and coverage processes and how innovators can better navigate the system and;

* AHRQ’s role in promoting quality research and value exchanges and how these benefit innovators.

For more details, contact the HHS press office at (202) 690-6343.

And tell them Drugwonks sent you.

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A Baucus Caucus

11/13/2008 11:46 AM |

Senator Baucus, in his white paper, "A Call to Action," says that "his door is open."  That's good news -- because when it comes to something as crucial and complicated as healthcare reform, a welcome mat beats a baseball bat.  To view the Senator's document, click here.  There's not a lot of detail -- more of a conceptual blueprint.  And that's the right way to begin.
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A Ray of Hope

11/12/2008 10:41 PM |

My candidate for FDA commissioner, Ray Woosley, (I said that to ensure he stays right where he is!) once again demonstrates that productive public-private partnerships are critical to promoting a new era of personalized medicine. Ray's leadership and dedication has sustained the Critical Path Intiative and supported the vision of Mark McClellan, Janet Woodcock and others at th FDA who launched it nearly 4 years ago.

 

C-Path Expands Partnerships to Speed Development of Critical New Drug Therapies

 

Dear Friend of C-Path:

Thanks to Arizona supporters, C-Path was created in Tucson four short years ago and we have been very successful in bringing drastic improvements to the methods used to evaluate new drugs and diagnostic tests; changes that are advancing personalized medicine. In addition, Arizona’s Governor, The Honorable Janet Napolitano, along with our state and federal legislators, have been very supportive of our work and our mission.

One of the state’s truly innovative new programs is Science Foundation Arizona (SFAz) which provides highly competitive grants to support meritorious collaborations between scientists and businesses in Arizona. Last year we were fortunate to receive one of the first of these highly competitive awards.

And again, I am extremely pleased to tell you that we have just been awarded a four year SFAz grant for $9 million. With this award, we will be able to expand our work and form additional industry-FDA consortia. These new consortia will improve our understanding of major diseases such as Alzheimer’s and Parkinson’s so that, when effective treatments are discovered, they can be developed in less than three years and with a 95% chance of success; not the current situation, 15 years and a 5% chance of success.

Thank you for your friendship and interest in C-Path.

Best wishes,

 

Ray Woosley

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