Is Comparative Effectiveness Comparison Shopping?

03/17/2009 05:21 PM |

A nice piece on comparative effectiveness by Ceci Connolly of the Washington Post.  No pun intended.  Nice in that it underscores the limits of comparative effectiveness and it's link to consumer choice rather than top down directives. 

However, there are limits that Connolly's piece did not discuss and which likely will be silence by the IOM panel which is stacked with people who believe that the one size fits all, literature review, take it or leave approach of comparative effectiveness is the key to  universal coverage.  This (with some rare and sensible exceptions) is a panel of patronage appointees intended to suppress responsible, science based alternatives to evaluating treatment effects.  I will have much, much more on this subject in a forthcoming post.  But for instance, don't expect the IOM panel, which is stacked to simply implement an AHRQ agenda that they have developed and receive millions from to address the following issues:

Which drug or treatment works best for an individual based on a variety of factors including genetic variation, co-morbidity, life style preference, stage of life? 

Moreover, will comparative effectiveness force additional studies before a product is paid for?  If so, that will inevitably delay access, raise prices or reduce rates of innovation.  And if trials have to be randomized for each subpopulation the cost goes higher still. 

The drug effectiveness review studies conducted by DERP fail to control for subpopulations and the literature they look at themselves exclude adjustments for severity of illness, genetic variation, etc.   So most "studies" show no difference in drugs for a particular illness when in fact there are substantial variations, particularly in the areas of depression, schizophrenia, hypertension. 

Therefore, shouldn't money be spent on tools for personalized medicine instead of one-size fits all guidelines?  Read More & Comment...

Career Advice

03/17/2009 11:48 AM |

Sources inside the Obama administration assure me that they have no plans to bifurcate food/tobacco from drugs/devices.  In other words, Commissioner-designate Hamburg and proposed Principal Deputy Commissioner Sharfstein will act as a team in addressing the direction of the FDA as a totality.

That being said, the issue of whether or not food safety and security remains inside the FDA or becomes its own agency within HHS remains as contentious as ever, with Representative Waxman and Representative DeLauro agreeing to disagree.

Mr. Waxman (D-CA) believes that the "first step on the legislative path" should be shoring up food safety and finding ways to prevent further incidents. According to the Pink Sheet, “Waxman did suggest that he would entertain the concept of a bifurcated agency in the future. Once reforms are passed and implemented, he suggested Congress could consider "whether a reorganization is necessary" for food safety enforcement.”

But Representative Rosa DeLauro, (D-CT), the chair of the House Agricultural Appropriations Subcommittee which oversees FDA's budget, has introduced the Food Safety Modernization Act, which would move some divisions out of FDA and form a Department of Health and Human Services agency for food safety. The bill, H.R. 875, has 40 co-sponsors.

That being said, a dangerous bifurcation that must be avoided at all costs is a differentiation in the vision for the future of the FDA between appointees and career staff.  Drs. Hamburg and Sharfstein should listen and learn from the agency’s senior staff – most specifically as to how the agency can be both regulator and colleague with the industries it regulates.  A fine line to walk -- but a journey worth the effort.

Exhibit A:  The Reagan/Udall Foundation and the Critical Path Initiative.

After all, the FDA must work to both protect and advance the public health.

A shared vision, crafted together will succeed. 

Unity, yes.  Bifurcation, no.

Yes we can.
  Read More & Comment...

Stark Mad

03/17/2009 04:35 AM |

  Read More & Comment...

Taxing Benefits

03/16/2009 10:48 AM |

During the election, candidate Obama called candidate McCain’s proposal to tax employer-provided health benefits “the largest middle-class tax increase in history.” Today President Obama is sending signals that he would support the same idea.

Representative Pete Stark (D, CA) says it's a "stupid idea."

According to the New York Times, such a tax could raise $3.6 trillion over a decade to help “expand coverage to the 46 million uninsured Americans.”

(The complete New York Times article – worth a read – can be found here.)

Except when you take an honest look at who is being inappropriately included in that 46 million (4.1 million now eligible for government benefits via expanded SCHIP + 12 million already eligible for government programs but not signed up + 10 million illegal aliens, + 10 million Americans “opting out” = 32 million) it really comes out to about 14 million uninsured Americans.

$3.6 billion (over 10 years) + the President’s proposed $634 billion “down payment” (over 10 years) divided by 14 million uninsured.  Talk about healthcare inflation!

(And this isn't counting the dollars allocated via the stimulus package that provides unemployment insurance-eligible Americans and their families with government health insurance as part of their benefits.)

For more on miscounting the uninsured, see “Sasquatch Care.”

Another thing the candidate Obama was against but now supports seems to be drug importation.  Can support of government price controls be far behind?
  Read More & Comment...

Uncle Sam, MD? Not So Fast.

03/13/2009 01:36 PM |

According to Douglas Schoen (formerly a pollster for President Bill Clinton) and Scott Rasmussen (president of Rasmussen Reports, an independent national polling company), “It is simply wrong for commentators to continue to focus on President Barack Obama's high levels of popularity, and to conclude that these are indicative of high levels of public confidence in the work of his administration”

Relative to healthcare reform, they find that a majority of Americans aren’t so keen after all to have their Uncle Sam become Uncle Sam, MD:

“There is no real appetite for increasing taxes to pay for an expanded health-insurance program. Less than half would support such an idea, which is 17% less than the percentage that supported government health insurance when Bill Clinton first considered it in March of 1993.”

(Their complete opinion piece in today’s edition of the Wall Street Journal can be found here.)

The conclusions reached by Schoen and Rasmussen are completely in line with a poll fielded by the Center for Medicine in the Public Interest last October.

The CMPI survey was of “Millennial” voters (18-28 years old) -- often portrayed as the new “driving force” in American politics.  When millennial voters were engaged on the issue of health care reform they had some very strong – and often contradictory – opinions a -- particularly when it comes to issue of “universal care.”

The national public opinion poll of young voters (the result of 1001completed interviews with adults 18-28 years of age who are registered to vote) shows limited acceptance for the potential consequences of greater government control over health care.

While millennial voters report to strongly support the need for reform and the concept of “universal care,” when asked if they are willing to pay higher taxes to pay for a government-run health care system, their level of support swiftly turns in the opposite direction.

Millennial voters are strongly against government-care that results in longer wait times to see a health care provider, limits to the types of treatments and medicines they can access, and the potential for the government to interfere in the decision making and relationship between doctor and patient.

Some germane findings:

* A majority (51 percent) were not in support of any health care reforms that could raise their personal tax burden;

* Sixty-two percent said they would not support any health care reforms that could increase wait-times to see a doctor or the availability of treatments and medicines; and,

* Millennial voters were also equally unsupportive (62 percent) of health care reforms that would increase the role of the government regulation and oversight in doctor-patient decision-making.

(For further details on the CMPI poll, see “The Young and the Restless.”)

The CMPI poll and the findings of Schoen and Rasmussen demonstrate that all sides of the debate need to do a better job educating Americans about how various reform plans will impact the future of our healthcare system.

Nobody said it was going to be easy. 

  Read More & Comment...

Conflict of Interest For Thee But Not For Me

03/12/2009 07:27 PM |

  Read More & Comment...

Pawlenty of Advice on Healthcare Reform

03/12/2009 06:26 PM |

To watch CMPI’s interview with Governor Pawlenty, click here.
  Read More & Comment...

NICE -- and Necessary

03/12/2009 01:01 PM |

SUTENT SIGNIFICANTLY INCREASES PROGRESSION FREE SURVIVAL FOR PATIENTS WITH ADVANCED PANCREATIC ISLET CELL TUMORS,
STUDY STOPPED EARLY

NEW YORK, NY, March 12 -- Pfizer Inc announced today that a phase 3 clinical trial of Sutent (sunitinib malate) has been stopped early after the drug showed significant benefit in patients with advanced pancreatic islet cell tumors, also known as pancreatic neuroendocrine tumors.

An independent Data Monitoring Committee (DMC) recommended halting the trial after concluding that Sutent demonstrated greater progression-free survival compared to placebo plus best supportive care in patients with pancreatic islet cell tumors.

“We are delighted by these findings which demonstrate that Sutent provides a benefit for patients with advanced, well-differentiated pancreatic islet cell tumors — a rare cancer with limited treatment options,” said Dr. Mace Rothenberg, senior vice president of medical development and clinical affairs for Pfizer’s Oncology Business Unit.  “These and previously reported phase 2 data contribute to the growing body of evidence indicating activity with sunitinib in patients with pancreatic islet cell tumors.”

Pfizer has notified clinical trial investigators involved in the trial and regulatory agencies of the DMC recommendations.  All patients in the trial will have the option to continue taking Sutent or be switched from placebo to Sutent.  The full data set from this trial is being analyzed and more details will be presented at an upcoming scientific meeting.

This phase III trial of sunitinib in patients with advanced pancreatic islet cell tumors was initiated based on the results of a earlier phase II trial published in the Journal of Clinical Oncology(July 2008).

In contrast to exocrine pancreatic adenocarcinoma, pancreatic islet cell tumors are rare, indolent tumors of the endocrine pancreas with an incidence of 5-10 per million worldwide annually.  Pancreatic islet cell tumors include insulinomas, glucagonomas and gastrinomas.  Current treatment options are limited.

Sutent is currently approved for both advanced renal cell carcinoma (RCC) and second-line gastrointestinal stromal tumor (GIST), based on efficacy and safety data from large, randomized Phase 3 clinical trials.  Sutent has played an important role in reshaping the treatment landscape for these two difficult-to-treat cancers.  To date, more than 38,000 patients globally have been treated with Sutent in the clinical setting and trials.

This is the second phase III Sutent trial Pfizer has stopped early on the recommendation of an independent data monitoring committee due to benefit.  In January 2005, a phase III trial in GIST was unblinded early when a planned interim analysis showed significantly longer time to tumor progression with Sutent compared to placebo.

  Read More & Comment...

A Sound Peg in a Care Shoal

03/12/2009 11:54 AM |

Commissioner Hamburg and Deputy Commissioner Sharfstein. Does this mean a partnership where one addresses the FDA’s food-side mission (Hamburg) and the other drugs and devices (Sharfstein)? Does it mean that the FDA will be under the thumb of Representative Henry Waxman? (Dr. Sharfstein was a former Waxman staffer.) Or does it mean that the FDA now has the political cover to remove the knife from its back and get back to work?

Will Dr. Sharfstein’s strong support of more robust OTC labeling help or hinder the FDA’s move towards a BTC (Behind-the-Counter) regulatory paradigm?

How will Dr. Hamburg address the dire state of food safety and security at an agency that gets dinged by our elected representatives – but for which Congress is slow to write a bigger check? Will Dr. Hamburg fight for an FDA food safety and security stimulus package? She certainly has the bona fides to do so.

And what about DTC? Will we see more letters (a perennial Hanukah wish from Mr. Waxman) or a move towards brighter lines from DDMAC?

And then there’s the question of REMS plans and complete response letters.

And biomarkers.

And guidance on off-label promotion.

And follow-on biologics.

And bioequivalence for generics.

And drug importation.

And comparative effectiveness for NDA submissions.

And companion diagnostics.

And 510(k) reform.

And greater international harmonization.

And the working relationship with the senior career staff at FDA.

And working relationships with industry and academia.

And, and, and …

Many questions. Few answers.

Here are seven things for Dr. Hamburg and Dr. Sharfstein to consider:

1. A Strong, Science-Based FDA

Everybody benefits from an FDA that leads. This means the agency has to be out in front of every issue for which it is responsible. Every specific action the agency takes is an opportunity to speak to a larger public health issue. Vioxx, for example, was a missed occasion for the FDA to seize the day on the issue of drug safety. When the FDA confidently leads, other stakeholders follow with their expertise, resources and sense of duty. This is not a people-intensive proposition. But it does require the commitment and the skill to do it – and do it right and regularly.

2. The Reagan/Udall Foundation: A Partnership of Unequals

The FDA must be both regulator in protecting the public health and colleague in helping to advance it. This is a delicate balance and in the current political climate the agency gets no merit points for being seen as collaborating with those it regulates. The best way to do this is via the Reagan/Udall Foundation. Now that the election is over an immediate first step should be for the new FDA Commissioner to meet with Representative DeLauro and issue a joint announcement on moving forward with the work of the agency’s Critical Path program to develop the tools necessary for 21st Century pharmaceutical and medical device development and regulation. But FDA must be seen as leading rather than simply participating in the process.

3. Clarity vs. Ambiguity

Regulators often love ambiguity – because ambiguity is power. The problem is that such a philosophy can lead to regulatory dissonance – ranging from completed Phase III trials supported by the agency at advisory committee meetings and then derided by a division afterwards, to warning letters sent to companies over marketing materials that have been “pre-cleared” by DDMAC. If people want the various industries regulated by the FDA to follow the rules, there need to be as many bright lines as possible – and they need to apply to everyone equally. While a high degree of pragmatism will always be required, this is not an excuse for “I know it when I see it” regulation.

4. Information Management

The FDA’s information management system is dysfunctional. The FDA sits at the crossroads of vast amounts of information that is of vital use to both protecting and advancing the public health. –yet most of it is unusable. The new Commissioner should immediately appoint an IT Czar who, as her first order of business, should audit existing systems and draw up an information technology roadmap for the agency. A solid “taskforce of talent” is needed to address this tremendous opportunity. Solid information management systems will allow the agency to do its job better, faster, and less expensively. A solid public health triple play.

5. Food Safety and Security

The agency’s programs on food safety and security are failing. Resources at CFSAN (the Center for Food Safety and Applied Nutrition) are stretched drum tight. More money is certainly needed – but there is also a crisis in confidence that the agency knows what it’s doing – or that it cares. The issue of BPA (bisphenol A) is a good example. The FDA was purely reactive in its call for a review by its panel of experts. As a result, the agency was destined to have its judgment called into question whatever the decision. And this is precisely what happened. This further cements the general perception that the FDA doesn’t care and/or is beholden to the industries it regulates. The BPA issue was out there for a long time in a visible way. And the agency didn’t do anything. It didn’t lead, it followed. And the consequences shouldn’t have surprised anyone. A similar situation is brewing with melamine in baby formula. Further, there is a growing sense that CFSAN should be moved to its own independent status within HHS. Perhaps. But for this to proceed, serious thinking needs to go into two issues: (1) DSHEA and the regulation of dietary supplements as foods, and (2) the increasingly important issue of nutriceuticals and qualified health claims. Both are clearly FDA issues and should remain so.

6. Risk Communications

Rather than assuming the mantle of responsibility and proactively stepping forward with more regular and transparent risk communications programs, the FDA was driven by the winds of crisis. Today the agency has implemented certain programs (some required by FDAAA) that provide risk information – but without any context, rhyme or reason. The result is confusion among patients and physicians and a field day for the media. The unintended consequences have swamped the public health benefit. Senior agency leadership knows it – but what are they doing to address it? The answer is not clear. A good beginning would be for the FDA’s Risk Communications Advisory to look into the matter. This problem needs to be fixed as no one (not industry, not doctors, not patients,) is happy with the current state of affairs.

7. The Drug Label and the “Safe Use” of Drugs

Wyeth v. Levine notwithstanding, the drug label is the single most important piece of communications material the agency issues – and it isn’t working as well as it should. The New Physician Labeling Rule (January 2006) has had minimal impact for three main reasons: (1) It has not been widely adopted for products licensed prior to the rule (not a requirement, but an option), (2) There has been little agency out-reach to physicians and, (3) There has been no broader agency program on the issue of “safe use.” This last point will change in January when the FDA (via CDER – the Center for Drug Evaluation and Research) launches a more comprehensive “safe use” initiative. The agency must consider not just safety, efficacy and quality – but safe use as well. Not just drug safety, but patient safety. This makes perfect sense and gives the FDA the opportunity to speak not only to physicians, but to consumers as well. The program should be expanded to also include medical devices. It is a timely, important, and urgent opportunity and must be done with determination, creativity, and relentless passion. It must be the FDA on the offense for the public health. And the offense must never stop.

Good luck Peggy. Good luck Josh.

Let’s get to work.

  Read More & Comment...

Will Hamburg Lead Like Lederberg?

03/11/2009 09:44 PM |

Media accounts note FDA Commissioner-in-Waiting Peggy Hamburg's stint as NYC Public Health commissioner.

But to me her best credential was her long scientific association with Dr. Joshua Lederberg.

Dr. Lederberg cared about the FDA, the Critical Path, the swamping of 21st century science by junk science, fear mongering, the dumbing down of drug companies and reimbursement systems that discouraged innovation.

Great minds don't think alike. They are independent. But they also can withstand the political bluster in support of science and medical progress.

Josh Lederberg did this and more.

Let's hope Peggy Hamburg, whose scientific and public health credentials are excellent, does the same. Let's hope she supports the Janet Woodcocks, Bob Temples, Larry Lesko's and others who want to lead the FDA into a future of personalized and prospective medicine and food safety and not the fearmongers from in and outside the agency that want to bring it down because the hate the commercialization of medical knowledge.
  Read More & Comment...

NHS: From Nanny State to "Show Me" State?

03/11/2009 11:57 AM |

Is comparative effectiveness entering a new "show me" state?

Bloomberg reports that,

"For two years, Pfizer, Inc. was quietly giving free doses of its expensive cancer drug Sutent as part of a campaign to help persuade the U.K. to pay for it. Last month, Pfizer finally won. The agency that advises the U.K.’s National Health Service decided the medicine extended the lives of patients enough to justify its cost, as long as the first course of treatment was free. The campaign wasn’t publicized by Pfizer or the U.K. and was revealed in interviews with government and company officials. The campaign cost Pfizer about 2.5 million pounds ($3.5 million) and gained the world’s biggest drugmaker an advantage over competing products made by Roche Holding AG, Bayer AG and Wyeth."

“It’s a relatively new phenomenon, and I think we’ll see more of it,” said Chris Brinsmead, president of the Association of British Pharmaceutical Industry.

The creative pricing arrangements lower the overall expense for the National Health Service and improve the ratio of cost to benefit that the National Institute for Health and Clinical Excellence uses to determine if a medicine should be covered. In all, drugs cost the nation 11 billion pounds annually, about 10 percent of the total health-care bill.

Johnson & Johnson’s blood-cancer drug Velcade won coverage in 2007 after the New Brunswick, New Jersey-based company said it would pay back the government for people who didn’t benefit. Patients get the first four doses of the 762.38 pound drug, then are tested to see if they’ve responded to the treatment. Those who improved continue with the drug. Johnson & Johnson provides a rebate of about 3,000 pounds for those who didn’t respond.

According to Sir Michael Rawlins, Chairman of NICE, “We’re meeting them partway.”

The complete Bloomberg story can be found here.

It's a creative approach based on outcomes -- a giant step towards recognizing the importance of personalized medicine the folly of basing reimbursement decisions on large-scale general population studies.
  Read More & Comment...

Rotten Reuben

03/11/2009 02:12 AM |

No doubt this story will be all over the mainstream media tomorrow as another example of “tainted” industry-sponsored research.

Now this is a terrible case of ethics abuse – but trying to pin the rap on industry (in this case, Pfizer, Merck, and Wyeth) is quite a stretch.

But that won't stop politicians from trying.  After all, nothing like a little Pharma-bashing to get the electorate all hot and bothered. Case in point, Connecticut Attorney General Richard Blumenthal who commented that, “When the public and professionals rely on statements from purported experts with financial interests ... the public trust and credibility are at stake.”

Except that it wasn’t the funding that was the problem – it was the absence of ethics by a rogue anesthesiologist.

It’s also important to note that the majority of scientific fraud comes from non-industry sponsored research conducted by academic institutions -- a result of the “publish or perish” survival of the fittest paradigm.

Here’s the full story.

Take this Reuben off the menu.
  Read More & Comment...

IOM Panel on Comparative Effectiveness Stacked With Rationing Proponent

03/11/2009 01:34 AM |

They include Mark Helfand who gets the bulk of the comparative effectiveness cash from the federal government, Joe Selby of Kaiser who also gets AHRQ money and Sean Tunis, another AHRQ recipient.  Not the least of whom is Alan Garber who compares placing a price tag on human life to putting prices on a menu.

Oh and he gets dough from AHRQ too. 

All support using comparative effectiveness studies like the one's AHRQ and HMOs pay them to do to justify saying "no."  All that many, so few people.  How do you spell conflict?  Mark McClellan stands alone a voice of sanity.

Garber wants us to believe that comparative effectiveness leads to higher prices for companies. How about ten solid examples Alan?  This from a guy who has spent his life slaving to restrict access to new technologies for the VA, Blue Cross and other insurers.

  Read More & Comment...

Avandia for Alzheimer's?

03/10/2009 08:01 PM |

Science surprises.  To paraphrase Mark Twain, that's because it is not obliged to stick to possibilities while the half-truths spun by some in an effort to displace science have to be immediately and plausibly scary.

So with this said, how interesting that Avandia is the drug used (because of it's insulin producing properties) to determine if "insulin, by shielding memory-forming synapses from harm, may slow or prevent the damage and memory loss caused by toxic proteins in Alzheimer’s disease."  

You can read about the research here.  Note that neither Steve Nissen or Curt Furberg were asked to comment:

Here

And here.
  Read More & Comment...

PhRMA Strategy: An Alternative View

03/10/2009 06:06 PM |

The In Vivo blog makes a good case that the PhRMA approach has been working.  But here's the problem ...

The In Vivo observers state:  

"The full negative impact on the industry including cost reductions in the private market is estimated at $70 billion over ten years. Compare that to $117 billion that the health insurers are being asked to give up from reductions to Medicare Advantage payment rates and you can see why the health insurers are crying "foul" and complaining that the pain of health reform is falling disproportionately on them."

SInce brand Rx is only 7-9 percent of total health care spending does it make sense for drug spending -- which will come in the form of formulary driven rebates that ultimately hurt the mentally il and seniors the most --  to shoulder such a big chunk. 

And that's just the start...

"The fact that cuts to pharma revenues are within the tolerable range combines with the industry's position against smoking to create a good climate for working with the White House, HHS and Congress on two key industry objectives: (1) a well-crafted follow-on biologics bill and (2) control over patient co-pay levels for drugs and biologics."

CBO estimates $70 billion over ten years for FOBs.   A lot of the "savings" are expected to come from restricting access to drugs based on comparative effectiveness reviews.  Tack on another $100 billion.   That doesn't include 15 percent mandatory rebates some in Congress want to stick to drug companies for the privilege of participating in Part D.   CBO estimates another $100 billion out of that.    Let's round off to $400 billion over ten years or about 25 percent of total revenues for that time period.  Add to that the drop off in sales due to patent losses.... As the WSJ health blog noted a while back....  "Generic competition is expected to wipe $67 billion from top companies' annual U.S. sales between 2007 and 2012 as more than three dozen drugs lose patent protection. That is roughly half of the companies' combined 2007 U.S. sales."  There will be some offsets thanks to new products but with government policies slashing revenues with rebates, formularies, etc. the combined effect of all these proposals and the generic shift will be huge.

So, is PhRMA just preserving an eroding status quo in order to innovate another day or are buying into policies that will make innovation more difficult given their cumulative impact on the bottom line?  It remains to be seen.

Read Article

One thing is certain, I think the In Vivo folks are -- like many so-called "stakeholders" -- confusing having a seat at the table with what is really best for the industry and the public.     Especially now when the requirement for keeping that seat is suggesting that even legitimate questions about the direction of health policy are  "land mines" that could block the way of the Obama heatlh care express.

Read the In Vivo Blog Here
  Read More & Comment...

The Finite Mind

03/10/2009 02:57 PM |

Interesting follow-up article on the tempest-in-a-teapot issue of "The Infinite Mind" NPR radio program.

The article (by Jim Edwards) can be found here.

"Interesting" because he (refreshingly) calls it like he sees it -- specifically:

"Peter Pitts, a former FDA official and an executive at Manning, Selvage & Lee, a PR firm that represents pharmaceutical companies, informed producers of his financial ties to drug companies when he appeared as a guest on the show."

Here's what Bill Lichenstein (the producer of the Infinite Mind) had to say about that:

"… as executive producer of The Infinite Mind, I was not the producer of the episode in question. But with regard to our failure to disclose the pharmaceutical connections of one guest, Peter Pitts, Pitts was a guest on the show due to his being a former FDA official. We were not aware, nor was PBS’s NewsHour nor NPR, when they had Pitts on as a guest, of his pharmaceutical PR ties."

So, even though he wasn't aware he was aware.  Now that's an infinite mind!

Edwards continues:

That stands in contrast to Pitts’ own assertion, also on BNET Pharma, that he did disclose his ties to drug company clients: "When I was asked to appear on “The Infinite Mind,” I told the producer about all my affiliations — as I always do. … MS&L does no work at all for either GSK or Pfizer — and the work for Lilly is 100% in diabetes."

And Edwards ends the article as follows:

"Side note: There’s a slight “Rashomon” aspect as to whether Pitts disclosed his ties to MS&L and drug companies. It should not have mattered, however. Although Pitts was an FDA executive, he is now better known as a pro-industry voice and his clients are not a secret. The only reason Pitts is famous enough to make it onto radio shows is because he is tied to these companies. The mistake here was the show’s failure to do a simple internet search and disclose Pitts’ current job, not with whether Pitts mentioned his job prior to the interview. If you’ve ever met Pitts you’ll know that of all the things you can accuse him of, operating in a subtle, sub rosa fashion is not one of them."

Thanks for the clarification and (I think) the complement.

What remains curious and frustrating is that no one wants to discuss the actual content of the program.

Here is a link to my initial comments on the program (which also include a link to the actual program).

  Read More & Comment...

Billy Said What?

03/09/2009 06:21 PM |

Watch this interview of Billy Tauzin on CNBC.  The idea that people don't fill prescriptions because of cost alone is a very one-dimensional view of the problem.  Research shows that compliance with medicines falls off over time even when they are paid for.  In the short run, it's tiered formularies that are the problem. And how does the Honorable Cajun square "lower prices"  under a universal health plan while opposing  "price controls?"   What about comparative effectiveness? 




  Read More & Comment...

Two for the Price of One

03/09/2009 02:22 PM |

RPM Report-FDA Commissioner Hamburg: Administration Closing In On Official Announcement
By Ramsey Baghdadi

Agency transition team head Joshua Sharfstein to be FDA's number two in charge of drugs. Former New York City Health Commissioner Margaret Hamburg is preparing for confirmation hearings with the White House set to announce her nomination as FDA Commissioner shortly.Baltimore Health Commissioner Joshua Sharfstein will serve as Hamburg's principal deputy commissioner.

Hamburg's name was understood to be formally pushed by transition team co-chair and former White House Chief of Staff John Podesta, which explains her quick rise to the top of the Administration's FDA shortlist late in the process. Podesta is currently CEO of the liberal think tank Center for American Progress.

FDA's nationwide recall of peanut products due to salmonella tainting likely made Hamburg a more serious candidate for the job given her experience as head of health for the largest city in the US from 1991-1997.

Hamburg brings a number of important experiences and skills to the position. An MD who specializes in bioterrorism preparedness research, she served on the HHS transition for the Obama Administration.Hamburg's service under the Clinton Administration and head of a large health system appear to be two other important qualities for a top health post in this administration. In 1997, she left the NYC health department and was named assistant secretary for policy and evaluation at HHS under President Clinton.Hamburg will reportedly handle food and tobacco issues-assuming FDA is given regulatory authority over those products-while Sharfstein will oversee drug, biotech and medical device issues.While the arrangement raises questions over the effectiveness of a de facto two-headed agency, it serves as a palatable compromise among Congressional lawmakers and key industry stakeholders.It became common knowledge that the drug industry opposed Sharfstein as FDA Commissioner due to his close ties to House Energy & Commerce Committee Chairman Henry Waxman (D-Calif.); he was previously a health policy advisor to Waxman on the Democratic staff for the House Government Reform Committee.Naming Sharfstein principal deputy gives Waxman access to FDA without the perception of total control over the agency, while also ceding authority over the drug industry to the former Waxman staffer. The number two position also saves Sharfstein from going through the Senate confirmation process.The nomination of Kansas Governor Kathleen Sebelius as HHS Secretary appears to have had little consequence on the choices at FDA and CMS, which were cemented before the withdrawal of Tom Daschle as HHS Secretary on Feb. 3.Institute for Health Care Improvement CEO Don Berwick is expected to be named CMS Administrator with an unusually large number of deputies as Medicare takes center stage in the health reform debate. Harvard economist David Cutler will serve as principal deputy with authority over Medicare coverage reform.  Read More & Comment...

Out of Africa

03/09/2009 11:57 AM |

  Read More & Comment...

Preemption Post Mortem: Cutter Rises Again

03/06/2009 09:03 PM |

I think Ted Frank at Overlawyered captures my feeling about the Supremes rendering of Wyeth v. Levine: 

After the Wyeth v. Levine argument, I worried that the Supreme Court might decide the case on such narrow grounds that it would do little good to confront the problem of trial-lawyer abuse. I now see I wasn’t nearly pessimistic enough.

We can put the nail in the coffin in the idea that this is a pro-business Supreme Court: the 6-3 Wyeth v. Levine decision is the worst anti-business decision since United States v. Von’s Grocery, 384 U.S. 270 (1966). Justice Thomas’s confused concurring opinion is especially disappointing, as it declares an abdication of the Supreme Court’s appropriate structural role to prevent individual states from expropriating the gains from interstate commerce.

Sell your pharmaceutical stocks now, because the Supreme Court just declared it open season on productive business. One should now fear the coming decision in the as-yet-to-be-briefed Clearinghouse v. Cuomo, and the effect that is going to have on an already battered banking economy, as well.

Beck and Herrmann have first thoughts, but are likely to be relatively quiet thereafter.

http://overlawyered.com/2009/03/wyeth-v-levine/

The majority wrote that:

"State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-warn actions, in particular, lend force to the FDCA’s premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times. Thus, the FDA long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation.12 The agency’s 2006 preamble represents a dramatic change in position. "

The court fails to provide any evidence of unknown drug hazards, but that's nitpicking.  But if the court does find one I guess that includes information that was already on the label?  Or how about "information" based on a meta-analyses or conjecture that a plaintiff brings forward that was perhaps discussed and dismissed by the FDA and companies?  If a jury decides that such "information" reveals a safety risk should that be considered a "failure to warn"? 

The impact of this decision will be threefold:

1.  Like the Cutter polio decison, Wyeth v. Levine breaks new legal ground.  In Cutter  a jury found that "pharmaceutical companies are liable for damage without negligence, even if they make a product according to industry standards using the best science available."   Here the court finds that companies are liable for damage even when the risks are clearly stated and for risks that may not be obvious or proving using the best science available.  

2.   The decision will raise the cost of making new drugs and vaccines.

3.  The decision should dash the hopes of the HMOs who thought that a comparative effectiveness commission would shield them from denying access based on a quasi-government study.   If anything, comparative effectiveness, since it is more of squishy methodology than measuring biological response to medicines, will be easier to attack from a legal or class action standpoint. Want to deny using genetic tests on grounds of cost-effectiveness?  Just wait till the first lawsuit comes along claiming damages because of a refusal to test for adverse events or response.  

Ironically, pharma and biotech firms could be in a better position to adapt to the new ruling with biomarker based development and post market technologies.   Meanwhile, health plans that seek to rely on the FDA label as a basis for denying coverage should think very hard about the implications of this decision.

  Read More & Comment...