Marketplace on the Marketplace

05/20/2011 09:23 AM |

Insurers begin to adapt to health reform law

By Jennifer Collins Marketplace Morning Report, Friday, May 20, 2011

Listen to this Story

In order to pay for the coverage they'll have to provide for those with preexisting conditions, health insurance companies have been trying to raise premiums by double-digits. Come fall, they won't be able to without approval.

Jeremy Hobson: The federal government has announced new rules for health insurance companies as part of the Obama health care law. Starting September 1 companies will have to get approval if they want to raise premiums by more than 10 percent.

The insurers say that'll lead them to drop coverage in some areas, as Marketplace's Jennifer Collins reports.

Jennifer Collins: One of the big promises of health care reform is that everyone in the U.S. can get coverage, regardless of preexisting conditions.

Ethan Rome is with Health Care for America NOW! He says insurers anticipate paying for all those preexisting conditions.

Ethan Rome: And they've been jacking up rates at double-digit levels.

Starting this fall, if insurance companies want double-digit increases, they'll need permission to do it on individual or small group plans. Peter Pitts is with the Center for Medicine in the Public Interest.

Peter Pitts: Certain insurance companies will just decide not to do business in certain states and areas where they simply can't get the rates they need to stay in business.

Christopher Bowe is a health care analyst with Informa.

Bowe: My guess is they'll be flexible and look for ways to change their business model to stay profitable and become more efficient.

He says insurers have shown flexibility. The health insurance industry is on its way to a third year of record profits.

I'm Jennifer Collins for Marketplace.

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Center for Public Integrity Smears Mitch Daniels and Misrepresents The Facts

05/19/2011 12:50 PM |

My American Spectator article on how the  Center for Public Integrity  uses allegations, omissions and misstatements to attack Governor Mitch Daniels.  Note that CPI claims it is "thorough and objective."  

Political Hay

Smearing Mitch

By Robert M. Goldberg on 5.18.11 @ 6:07AM

The Center for Public Integrity (CPI) recently issued a report accusing Governor Mitch Daniels, who once was President of North American operations for Eli Lilly, of illegally marketing medicines that caused thousands of people to get sick and die.

It's a riveting story but it's not true. Instead, the report, written by Joanne Kenen and Rochelle Sharpe, is full of misstatements, inaccuracies, and outright falsehoods. If the Center for Public Integrity had any integrity it would yank the piece, apologize to Governor Daniels, and start asking who pushed to release such a sleazy ad hominem assault.

Here's the gist of the allegations:

In the decade that Daniels climbed the corporate ladder at Eli Lilly, the company was illegally marketing its leading osteoporosis drug, Evista, as well as its blockbuster antipsychotic, Zyprexa, putting tens of thousands of patients in harm's way. Lilly pleaded guilty to two criminal misdemeanors, paid more than $2.7 billion in fines and damages, settled more than 32,000 personal injury claims -- and copped to one of the largest state consumer protection cases involving a drug company in U.S. history, a review by iWatch News shows.

Eli Lilly engaged in illegal activity. But here's the gist of its unlawful actions: Eli Lilly was accused of providing doctors with medical information that Zyprexa could be used to treat agitation in people diagnosed with dementia and sleep disorders in people with schizophrenia. The government calls the distribution of such material without FDA approval a "false claim." A "false claim" is not a false statement. Rather, it's clinical data or published studies that confirm the effectiveness of new uses for existing medicines.

In other words, if Eli Lilly shared medical studies demonstrating that using a drug prevents cancer, it would be breaking the law.

In fact, that's what Lilly was fined $36 million for in 2005. The government had gone after it for telling doctors that Evista -- originally approved to reduce bone loss -- was also effective in preventing cancer in postmenopausal women. In 2007 the FDA approved Evista as a cancer preventive. During this time Medicare and Medicaid were paying for the off-label use of both Zyprexa and Evista.

Kenen and Sharpe also allege that under Daniels Lilly downplayed Zyprexa's side effects of significant weight gain and increases in blood sugar that could cause diabetes. In fact, the federal judge presiding over Zyprexa litigation noted "the original 1996 Zyprexa label listed the relevant adverse events; in 2003 the FDA… required a hyperglycemia and diabetes warning; the American Diabetes Association and other groups in 2003… issued a consensus statement on antipsychotic and weight gain and diabetes… a Dear Doctor Letter went out in March 2004. "

Further, since 1999 the company has published hundreds of articles examining the association between Zyprexa, glucose levels, and obesity and including research intended to help predict weight gain. That's in addition to scores of other papers written by others.

Still Kenen and Sharpe want to link Daniels to thousands of Zyprexa-caused injuries and deaths. To dramatize their case, the authors introduce us to Ellen Liversidge, who states: "Eli Lilly killed my only son." Her son Rob, 39, died in 2002 after taking Zyprexa. "I think they are terrible. They hid the side effects of so many drugs."

In fact, as Liversidge notes in another interview, her son died because "the intensive care unit team did not have his blood-sugar level checked for signs of hyperglycemia."

Liversidge is a member and founder of two organizations with ties to Ann Blake Tracy, an advisor to the Scientology-backed Citizens Commission on Human Rights, and Dr. Peter Breggin, who over the years has claimed that treating mental illness with medicine is a form of abuse.

Breggin has been an "expert witness" in many of the lawsuits against Zyprexa.

And Breggin is also a featured blogger on the Huffington Post, whose founder, Arianna Huffington, is a CPI board member.

Huffington and Breggin share a particular animus against Eli Lilly and Daniels in particular.

Since 1998, Huffington has waged a war of words against Eli Lilly for promoting Prozac and Zyprexa. She alleged in 2002 that Daniels was behind an effort to protect vaccine makers from lawsuits from parents who claimed shots made by Lilly and others caused their children's autism because they contained thimerosal. In 2005 she launched the Huffington Post and featured several anti-vaccine and pseudoscience fearmongers as bloggers, including Andrew Wakefield, Jenny McCarthy, and of course, Peter Breggin.

Did either Breggin or Huffington suggest or contribute to CPI's report? The link between CPI and Huffington's campaign against Mitch Daniels bears more scrutiny than the baseless claims that the Indiana governor presided over an orgy of criminal behavior.

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What's the oppostite of Mission Creep?

05/19/2011 08:26 AM |

CDER no evil?

Via BioCentury ...

CDER seeks to limit scope of Avastin hearing

FDA's Center for Drug Evaluation and Research said it does not believe future studies of Avastin bevacizumab are within the scope of a hearing on FDA's proposed withdrawal of metastatic breast cancer from Avastin's label. In a letter from CDER to CBER Director Karen Midthun, who is presiding officer for the June 28-29 hearing, CDER said future studies are not relevant to the center's conclusion that currently available data have failed to confirm the safety and efficacy of Avastin for the indication. CDER argues in the letter that the topic of withdrawal should be considered separately from the topic of future clinical trials. Genentech Inc. said it is submitting a response to CDER's letter.

However, Midthun has already indicated that future trials are a topic for discussion at the hearing. If the FDA commissioner agrees data provide grounds for withdrawal, the hearing will consider whether Avastin's accelerated approval should be maintained while Genentech conducts a confirmatory trial, according to the hearing's Federal Register notice posted last week. On Monday, the Roche (SIX:ROG; OTCQX:RHHBY) unit indicated it would focus its argument on that question.

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Hunter/Gatherer

05/18/2011 08:37 AM |

Lead, follow ... or get out of the way.

From the pages of Health Policy News:

FDA Weighs Role of Social Media In Agency Communications

FDA is seeking social media advice for its own communications practices as it crafts a much-anticipated guidance to govern the drug industry's utilization of Web 2.0 tools, with the agency struggling with how much its outreach efforts should include new Internet-based applications. The agency is mulling whether to take a more active role in social media outlets to interact with the public on issues like recalls and enforcement actions, but a former FDA communications official said the agency needs to embrace new media now to fulfill its public health mandate and to set an example for the industries it regulates.

As more doctors turn to social media to communicate with patients and because it has proven to be a vital tool in drug crises, FDA is evaluating how much it should participate in this evolving platform, indicating that it is a "gray area" for the agency to have staff actively participating in tools like Facebook and Twitter, agency officials said May 6 during a Risk Communication Advisory Committee meeting.

Advisory committee members and FDA officials indicated that by, for example, following people on Twitter, the government would have more interaction with the public. Greg Busse of the drug center's safety and risk communications team, said the psychological power of such an action would allow the government to engage in dialogue with with public.

"Whether or not it will ever come to light, whether it will work that way, I'm not sure," he said.

FDA has several Twitter feeds based on different topic areas, but each feed only follows a handful of government agencies and health organizations. The agency does not retweet information from other users. While following indicates whose information FDA is monitoring, retweeting, or sharing other users' ideas, indicates interaction with others on the media platform.

FDA has also researched the diffusion of and feedback from its message on various topics, including the peanut butter and egg recalls, action taken against Four Loko caffeinated alcoholic beverages and issues surrounding genetically engineered salmon.

Peter Pitts, president of the Center for Medicine in the Public Interest, told FDA Week that FDA needs to take action in the social media realm because it is where people are now getting their information and it advances the agency's public health mission. Further, he said the agency has already collected enough information through public meetings and studies to advance its use.

"Social media isn't an option," said Pitts, a former associate commissioner for external relations at FDA. "Social media is for many Americans their exclusive pathway for health information."

While all channels of social media should be embraced by the agency, he said video should be prioritized. The way the agency handles these platforms could direct industry, he said. "The FDA could do wonders by leading by example," said Pitts, who is also a consultant to the advisory committee.

Committee members said the agency could build trust and reinforce its message through the social media tools. "I think part of the challenge is sort of being authoritative and also accessible and responsive," one committee member said. Committee members also noted the repetition that comes from social media has positives and negatives as the agency's message could be manipulated and quickly disseminated.

The limited available space to convey risk-benefit information and viral nature of a social media message has also caused concern among industry, which has been pushing for guidance for how it can use these new tools without running afoul to marketing regulations. In recent weeks, FDA announced a series of studies on the Internet intended to inform the guidance, which in turn is likely to delay the document that has missed two goals for issuance.

During the meeting, Elisabeth George, a vice president with Philips Healthcare, questioned the committee on industry's responsibilities. As directed by the agency, "if there is any off-label use that is being done with our products or if there is any misinformation with respect to safety and efficacy, we need to take action ," she said. But it is unclear how far regulators expect industry to go in policing the information, she said.

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Duty. Honor. Patient.

05/17/2011 09:03 AM |

To paraphrase Douglas MacArthur, “The patient, and the patient, and the patient.”

That’s my optimistic take-away from yesterday’s Patient-Centered Outcomes Research Institute (PCORI) Board of Governors meeting.

But, you know what they say about best intentions.

The session began on a less than auspicious note with a PowerPoint presentation from the PCORI-retained public relations firm on how to best develop the institute’s “brand.” Suffice it to say there was a lot of multitasking going on.  What’s next on this particular agenda?  A PCORI theme song?

Then it was time to get down to serious business. And the first was the announcement of Joe Selby as PCORI’s first executive director. (He is a member of the Institute of Medicine, where he has studied quality and effectiveness issues. Selby joins Team PCORI from Kaiser Permanente in Northern California where he was director of the research division and oversaw a team of over 50 investigators and 500 research staff working on more than 250 ongoing studies.)

After PCORI Chairman Eugene Washington made the announcement, Selby commented, “For those of you participating in this meeting via webcast, I’m the one who looks like a deer in the headlights.”

Good luck Joe. You’ll need it.

Various discussion items followed. Of particular interest was that of PCORI undertaking (led by the Program Development Committee) of a Landscape Review of comparative effectiveness research (CER) – and this generated much debate.  Most important (and bear with me for a minute on this) was whether or not, once completed, this mega lit search should be posted on the PCORI web site.  It was astutely pointed out that this should not be the case – as it would give a sort of implied official imprimatur to the listed studies.  Surprisingly and positively there was general agreement that this survey should not appear online.

There was then a general discussion on what the “legacy” of PCORI would be.  And while that might sound a little grandiose and, well, premature – it did focus the board on what unique research role the institute can play in advancing the public health from a patient-centric perspective.

No real answer.  But a good question and the best comment came from NIH Director Francis Collins who said that if PCORI was looking for a unique and non-duplicative research agenda, it would be “a null set.”

Public comment followed. Mine consisted of the following points:

PCORI should not forget about outcomes data. Perhaps the institute should lead the way in coordinating the many large data sets of outcomes data held by both Uncle Sam and private payers.  The use of outcomes data needs to go beyond (well beyond) well-intentioned (but relatively small) CMS pilot projects.  The United Kingdom has such a nationwide system – but hasn’t been particularly creative or aggressive in using it.  PCORI should take the lead.  After all, what’s more patient-centered than real world outcomes data?

PCORI should create a program on educating patients, physicians and payers on the use and importance of molecular diagnostics.  After all, what’s more patient-centric than early diagnosis and advancing the “four rights” of the right medicine in the right dose to the right patient at the right time?

PCORI should help to advance the nascent science of adaptive clinical trials by creating and creating a home for www.adaptiveclinicaltrials.gov. After all, what’s more patient-centric than adaptive clinical trial information?

PCORI should stay as far away as possible from discussions of CER as a method for cost controls – as this is a slippery slope to price controls.  And price controls equal choice controls. Moreover, PCORI is officially tasked not to pursue comparative effectiveness but comparative clinical effectiveness. Comparative means which treatment (or healthcare technology if you prefer) is “better” (subjective) versus data on real world clinical outcomes. To put it bluntly, “comparative” is subjective. “Clinical” is outcomes-driven. It’s important to remember both the letter and the spirit of the stature.

(In fact, Francis Collins warned the board to “beware of the tension between CER and personalized medicine.)

PCORI should be careful in creating a databank of CER studies because (and particularly when you consider programs such as CATIE and ALLHAT) garbage in, garbage out.

PCORI should beware of information sharing via academic detailing. (Note:  20% of the PCORI budget is ear-marked to AHRQ for “information dissemination.) ‘Nuff said.

PCORI should (indeed must!) define “patient-centered” as care first and cost second – otherwise the “PC” in its acronym will only mean “politically correct.”

Next up was the report of the Methodology Committee and the centerpiece of this portion of the program was a working definition of “patient-centered outcomes research” (PCOR).  (Note: the word of the day was “iterative.") Here is the committee’s first draft effort

“Patient-Centered Outcomes Research helps people make informed decisions and allows their voice to be heard in assessing the value of healthcare options.  Given my personal characteristics, condition and preferences, what should I expect will happen to me?  What are my options and what are the benefits and harms of those options?  And what can I do to improve the outcomes that are most important to me?

Nice.  These “four questions of PCOR” should be widely shared and discussed.  If PCORI is looking ahead towards its “legacy,” this is a good place to start.

At the end of the meeting, one of the board members came up to me and said, “I don’t think you understand what PCORI is about.” She was confused that I had brought up the issue of cost controls in my remarks. “Don’t you know what we are, by statute, not allowed to take costs into consideration in our work?”

 I told her that I understood very well – but that, well, you know what they say about good intentions.

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Social Media, Pharma, and the Theatre of the Absurd

05/16/2011 08:16 AM |

Maybe they should call him Tom “Godot” Abrams.

Maybe not.  DDMAC continues to get slammed for not issuing the social media guidance it most recently promised to “try” to get out by the end of first quarter 2011.  While, on the one hand, one shouldn’t raise expectations (even by “trying”), DDMAC guidances (be they draft or otherwise) are a Trojan Horse.

The Bauhaus Boys said it best.  “Less is More,” opined the great Walter Gropius. “But” amended Mies van der Rohe, “More tastes better.”

Both are relevant to the issue of DDMAC and social media.  On the one hand, less (at least in theory) allows regulated industry to make its own rules, to find its own way. More, on the other hand, is what pharma seems to want. And, to be fair, predictability is always better than ambiguity when it comes to FDA regulations. Alas, that is not always possible – and expecting it (like Waiting for Godot) makes for absurdist theatre.

Here’s an article from the current edition of Ad Age that can be pretty well summed up in this quote from Samuel Beckett:

What do I know of man's destiny? I could tell you more about radishes.

FDA Guidelines Set for '10 Still Nowhere to Be Seen

Pharma Companies Still Waiting for Social-Media Guidance, but a New 60-Day Public-Comment Period Was Just Opened

Still waiting on those Food and Drug Administration pharmaceutical guidelines for social media and online advertising? Don't hold your breath.

The FDA has opened a 60-day public-comment period to study the impact of online consumer advertising for prescription drugs, further delaying the implementation of new rules for internet and social-media marketing -- rules that had been expected for months now.

The continuing delay is bad news for the industry, which is beset by stagnant new product pipelines and the patent expiration in the next 18 months of several blockbusters that account for more than $51 billion in annual sales, including Pfizer's Lipitor, the world's best-selling prescription medication. Big Pharma has looked to goose profits in several ways, including lowering ad spending with cheaper marketing platforms such as branded websites and social media.

Digital spending is on the rise -- eMarketer estimated that health-care and pharma companies spent $1.03 billion on internet ads last year, up 13.9% from 2009 -- but drug makers are inhibited from doing more by a lack of guidance for social media.

In a notice in the Federal Register, the FDA said it would conduct three concurrent studies in order to assess how current advertising rules governing print, radio and TV ads will apply to social media. Specifically, how do drug companies portray accurate and complete "fair balance" -- the risk and benefit information -- in a Facebook post or a 140-character tweet?

Though these studies and this new comment period that ends June 27 are separate from the agency's November 2009 hearing and public comment period on social media, the FDA said in its notice that the new study "will complement qualitative research we plan to conduct on issues surrounding social media."

Translation? Those social-media guidelines the FDA said it would deliver in 2010, and then put off until the first quarter of 2011, and are still nowhere to be seen six weeks into the second quarter. And they are still a long way off.

"This [new study] is completely different and it's completely irrelevant. This is just the FDA continuing to try to solicit input on what elements of advertising influence people in different ways," said Peter Pitts, former FDA associate commissioner and now the president of the Center for Medicine in the Public Interest. "What it's showing is just how behind the curve the agency really is."

The FDA admits the problem, saying in its notice in the Federal Register that, "The original regulations that presently determine FDA's position on DTC promotion were written at a time when the available media for DTC promotion were print and broadcast, and the primary audience was health care professionals. This dynamic is shifting, and evidence is needed to support guidance development."

There is, by and large, almost complete agreement in that assessment from all parties concerned. Now comes the waiting.

"To be candid, if you look at FDA historically, this is typical for them. FDA is loath to move quickly unless it involves product liability, like if someone is about to be poisoned by bad food," said longtime health-care agency executive Mike Guarini, the president of Connecticut-based Ryan TrueHealth. "Putting in social-media guidelines has become a joke. They don't know when they're going to do it, and neither does anybody else."

Asked if the delay is hurting business, Mr. Guarini said "Absolutely. No question about it. What I hear from clients and prospective clients is 'I want to do more in social media, but I don't know if it's good, bad or even legal.' The industry would just like some guidelines."

When that will be, however, remains to be seen. The FDA offered no timetable, saying only in its notice that "The series of studies described in this notice will provide data that, along with other input and considerations, will inform the development of future guidance."

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The Little Search Engine that (finally) Could

05/13/2011 08:58 AM |

Well -- maybe not so little.

In December 1, 2003, the Washington Post ran this story on the front page:

Google to drop rogue-pharmacy ads: Move is part of government effort vs. illegal drugs

Google, the popular search engine, will stop accepting advertising from unlicensed pharmacies that have used the Internet to sell millions of doses of narcotics and prescription drugs without medical supervision, company officials said.

The decision by Google Inc., based in Mountain View, Calif., comes as regulators and members of Congress shift their focus from the illicit pharmacies to the legitimate Web portals, credit card companies, shippers, and banks that facilitate the sales. Three congressional committees are looking into the issue.

Federal regulators, who have limited authority over online advertising, are examining how they can prod the search engines and other businesses to deal only with legitimate pharmacies.

 "We're literally placing calls to the search engines trying to get a meeting going," said Peter Pitts, the FDA's associate commissioner for external affairs. "You can't blame them for accepting commerce. But they really haven't understood the consequences."

Nearly eight years later, it seems those consequences are somewhat better understood. Today this story hit the pages of the New York Times:

U.S. Inquiry of Google on Drug Ads

Federal regulators are investigating Google on suspicion of illegally displaying ads for online pharmacies that are operating outside the law, government officials said Thursday.

Google has set aside $500 million to pay for a potential settlement, according to a Securities and Exchange Commission filing the company made on Tuesday. It said the money was for the “potential resolution of an investigation by the United States Department of Justice into the use of Google advertising by certain advertisers,” but gave no details.

In the last year, Google has made significant changes to its policies for accepting pharmaceutical ads, most recently in January. But Michael Zwibelman, litigation counsel for Google, has described it as “an ongoing, escalating cat-and-mouse game.”

In February 2010, Google changed its AdWords policy to accept ads only from pharmacies certified by the National Association Boards of Pharmacy in the United States or the Canadian International Pharmacy Association.

Better late than never.

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The Cost of CER

05/12/2011 09:52 PM |

On and off the battlefield, uncontrolled bleeding and inflammation from traumatic brain injuries (TBI) is the leading cause of death among our soldiers as well as young adults.  Over the past decade, a drug to control hemophilia has be used to stop brain bleeding faster TBI caused bleeds more quickly had helped reduce death and post TBI disabilities.   And recently scientists began work on a simple blood test for diagnosing head trauma as well as a new drug that shuts down inflammation itself.

Current treatments might not have been available if something called comparative-effectiveness research (CER) was in place ten year ago. CER compares the cost and effectiveness of old technologies in treating a disease to medical innovations. Under Obamacare, CER is being used in determining whether new technologies can be covered by health plans, Medicare and the Veteran’s Administration.  A recent CER study stated that there was no evidence that a clotting drug used to save the lives of soldiers in Iraq and Afghanistan as well as our neighbor’s kids was cost-effective.  What impact will CER have on future TBI treatments as well as other innovations developed to battle cancer, Alzheimer’s and Parkinson’s?

CER proponents such as Donald Berwick, the administrator of the Center for Medicare and Medicaid Services, believe that most medical innovation increases healthcare spending without adding any benefit.  They believe CER can be used to select innovations that can reduce costs without harming patients and free up spending for other purposes.

But CER only looks at the comparative cost of everything from the government’s perspective and the average response to the average person, not the value of innovations to our families and friends. More troubling, CER does not measure the impact of requiring more time, money and clinical trials on the number of innovations or what effect fewer innovations would actually have on our lives.

We conducted such a study.  And we found that the added time, cost and regulation could reduce R&D investment by $32 billion over the next decade.  That would cost Americans $4 trillion in economic activity and snatch 81 million years of life from our families and friends. Our research confirms the analyses of other economists that an increase in R&D is associated with increases in wealth and longevity.  For example, University of Chicago Economists, Kevin Murphy and Robert Topel, estimated the social-economic value of a 10 percent reduction in the mortality associated with cardiovascular disease and cancer around $10 trillion.

CER advocates such as Dartmouth University physician Jonathan Skinner believe that government should pay for any technology that costs more than $50,000 a year. They make no bones about the fact that many innovations would be not paid for under this formula.  Skinner believes that “the antagonism toward comparative effectiveness research…suggests a bit of magical thinking — the notion that the country can avoid the difficult trade-offs that cost-utility analysis helps to illuminate…It represents another example of our country’s avoidance of unpleasant truths about our resource constraints.”^[1]

In fact, our analysis suggests that the real trade-off isn’t between the government spending money on cancer drugs or pap smears or high speed railways. 

Yale University Economist William Nordhaus estimates the value of innovations in medicine during the second half of the twentieth century are about equal to growth in Gross Domestic Product (“GDP”) over the same fifty-year period. In other words, Nordhaus estimates that we could have spent more on food, clothing, entertainment, education, vacations, airplanes etc. and less on medical innovation. But in doing so we would essentially have to accept 1950’s levels of care over the past 50 years. 

Our research estimates what spending less on medical progress as a result of CER as another hurdle to developing and using medical technologies.  Our study confirms what Nordhaus and others have concluded: “the social productivity of health-care spending might be many times that of other spending. If this is anywhere near the case, it would suggest that the image of a stupendously wasteful healthcare system is far off the mark.”  And it suggests that CER is not only misguided, it’s dangerous to our health and quality of life too. That’s the unpleasant truth CER advocates seeming willing to ignore

 

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Portrait of the Regulator as a Savvy Public Servant

05/12/2011 09:34 AM |

Mistakes are the portals of discovery.

James Joyce

In a wise reversal, the FDA will now allow two hours of open public testimony during the first day of the (June 28-29) Avastin hearing.

Smart.

In further news, ODAC will vote on the fate of Avastin's breast cancer indication at the agency's hearing on the proposed withdrawal of the claim, marking the third time in four years that the panel has been formally polled on whether the VEGF inhibitor should be used in this population. It voted against approval the previous times.

The announcement that ODAC will have a voting role contrasts with CDER’s original expectation that committee members would be asked to provide advice and recommendations but not vote.

Karen Midthun explains that since this is an administrative hearing, procedures will differ from those of a typical advisory committee meeting and may bear more resemblance to a court case.

According to Karen, "It may help to think of this as, in some ways, like a trial." Representative and will lead the meeting. Panel members will have an opportunity to question witnesses appearing on behalf of Genentech and CDER.

"As with a typical advisory committee meeting, we will ultimately ask you to vote as a committee on the issues that are the subject of the hearing," the letter states. "There will not be an immediate decision by FDA at the hearing. Instead, as with an advisory committee meeting, FDA will consider the committee's input and will announce its own ultimate decision at a later date."

The Pink Sheet opines that, “The decision to give ODAC a voting role would seem to bode ill for Genentech in light of the panel's previous negative reviews of bevacizumab for MBC.”

But there’s a third option other than yea or nay. FDA is leaving an opening for Genentech to hold on to Avastin's metastatic breast cancer indication even if Commissioner Margaret Hamburg determines existing evidence has not demonstrated bevacizumab's efficacy or safety for this use.

Commissioner Hamburg can decide to retain bevacizumab's accelerated approval in first-line MBC while the company conducts additional studies to confirm clinical benefit even after determining that the grounds for withdrawing the claim have been met.

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Companion Diagnostics Now!

05/12/2011 09:19 AM |

The Pink Sheet reports that Roche/Genentech is seeking a broad label in metastatic melanoma for the just-filed oral BRAF inhibitor vemurafenib (formerly PLX4032) and priority review, which could possibly enable a U.S. launch at the end of 2011.

It's geared as a treatment for the roughly half of metastatic melanoma patients who test positive for the BRAF V600 mutation. A companion diagnostic to test for the mutation has been developed by Roche Molecular Systems, and has also been submitted for approval.

As a personalized therapy for the tough-to-treat disease, the drug has been widely described as a game-changer in melanoma.

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Sins of Omission

05/12/2011 09:10 AM |

Drug companies should not let overeager sales representatives make do-it-yourself Web videos and post them online without review by compliance experts.

Duh.

Warner Chilcott received for a notice of violation letter for a sales-rep-created-and-produced YouTube video promoting its new osteoporosis drug Atelvia (risedronate delayed-release), which featured a female sales representative talking about the drug to an enthusiastic staff member in a physician's office.

The letter was generated by a "Bad Ad" program complaint, and FDA noted that the video was never submitted via a FDA Form 2253 as required.

Oops.

According to the May 5 NOV letter to Warner Chilcott, which was posted to the FDA Web site May 9, "The video was posted by the sales representative on the website YouTube.com under the direction of a Warner Chilcott district manager."

Please note that this does not mean that YouTube is out of bounds.  It's not the channel that's non-compliant, it's the content.

Sins of omission are seldom fun.

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New Reports Show Comparative Effectiveness Research Could Cost Trillions

05/12/2011 01:35 AM |

Requirements under Obamacare could reduce medical innovation, cut economic growth and life expectancy

About CMPI

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A GSK-O

05/11/2011 09:38 AM |

From the Forest from the trees department, The Wall Street Journal reports:

A federal trial judge on Tuesday acquitted a former GlaxoSmithKline PLC lawyer in a high-profile corporate misconduct case, dealing a blow to the government's effort to target individuals in probes of the pharmaceutical industry.

U.S. District Court Judge Roger Titus in Maryland took the rare move of acquitting former Glaxo lawyer Lauren Stevens without sending the case to the jury.

Judge Titus called his summary move to acquit Ms. Stevens a first in his seven-and-a-half years on the federal bench. "The defendant in this case should never have been prosecuted and she should be permitted to resume her career," he said.

Prosecutors had alleged Ms. Stevens obstructed a Food and Drug Administration investigation into whether Glaxo had improperly promoted the antidepressant Wellbutrin for weight loss, a use not approved by the FDA.

The government's defeat points to the difficulty of prosecuting individuals over alleged wrongdoing at large corporations, where teams of people may be involved in a matter and it is hard to show that executives intended to break the law.

Despite calls for prosecution of top Wall Street figures in the wake of the 2008 financial crisis, the Justice Department has brought only a handful of cases against individuals, and lost some prominent cases.

Ms. Stevens's sudden acquittal could hurt other government efforts, including the long-running investigation of Glaxo for marketing issues related to several drugs, said defense attorneys. They said the Justice Department and the Department of Health and Human Services may have to review their larger strategy of targeting executives and lawyers at pharmaceutical companies.

The Justice Department cannot appeal Tuesday's acquittal. "We believe these charges were well-founded and that the jury should have been allowed to deliberate and decide this case," a department spokesman said.

Pharmaceutical companies have paid billions of dollars to settle various marketing-related charges with the government, but only a few executives have pleaded guilty to any crimes.

Government officials have said they decided to go after more individuals to create a stronger deterrent and prevent companies from viewing fines as merely "a cost of doing business."

Prosecutors alleged Ms. Stevens falsely denied that the company had promoted Wellbutrin for unapproved or "off-label" uses, despite knowing that the company had sponsored programs with doctors' groups involving Wellbutrin. Companies are barred from off-label marketing but doctors can generally prescribe an FDA-approved drug for any condition.

Defense lawyers for Ms. Stevens said she provided legitimate and zealous representation of Glaxo and relied in good faith on the advice she received from an outside law firm.

The judge agreed, saying it would be a "miscarriage of justice" to let the case get to the jury.

"We did not have a bad five minutes in that courtroom; if it had been a prize fight, they would have stopped it," said Ms. Stevens's lawyer, Reid Weingarten, who has represented Cabinet secretaries and corporate chiefs.

It is rare for the government to charge a lawyer over advice given to a client, because such conversations are generally protected unless the lawyer is helping the client commit a crime.

Judge Titus's ruling is likely to make such prosecutions rarer still. "There is an enormous potential for abuse in allowing prosecution of an attorney for the giving of legal advice," the judge said.

The government has long been investigating Glaxo over various allegations related to sales of antidepressants Paxil and Wellbutrin, as well as its former popular diabetes drug Avandia. Glaxo hasn't been charged with wrongdoing in these cases, but the investigation is continuing, according to people familiar with the matter.

Its outside counsel, King & Spalding LLP, didn't return calls requesting comment.

The government hasn't said whether the prosecution of Ms. Stevens was part of an effort to push Glaxo into a plea deal. It said in court documents in December that the Stevens case was part of an "ongoing underlying health-care fraud investigation" looking at her and "potential criminal activity by others."

The company has declined to comment on the cases, and it hasn't said under what terms Ms. Stevens left the company last year.

It said Tuesday that it was "pleased" with her vindication.

"The acquittal certainly strengthens Glaxo's hand in negotiations with the government about a corporate resolution of their case," said John Fleder, a defense attorney with Hyman, Phelps & McNamara PC who wasn't involved in the case.

FDA officials and the inspector general of the Department of Health and Human Services have said that the government wants to make more use of an administrative option to punish executives by excluding pharmaceutical company leaders from the industry. That option may look more attractive after the failure of the criminal case against Ms. Stevens.

Companies that employ an "excluded" executive can be prevented from selling products to the U.S. government—which almost all pharmaceutical firms do. In essence, the step can force a company to dump its chief in order to do business with Medicare or the Veterans Administration.

In April, the HHS inspector general created a firestorm in the drug industry when the agency said it intends to exclude the longtime chief executive of Forest Laboratories Inc, Howard Solomon. The company has protested the move and said Mr. Solomon had nothing to do with marketing violations for which the company agreed to pay more than $300 million in civil and criminal fines.

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Gary Schwitzer Continues Campaign of Hate Against Innovation

05/10/2011 03:52 PM |

Gary Schwitzer's HealthNewsReview Blog  (fully funded by the for profit HealthDialog, a point I raise only because Schwitzer makes a federal case about pharma funding of researchers) runs  healthnewsreview.org.   He has never found a new drug or treatment worth paying for.  Which raises the question of whether or not he would accept the state of medicine in 1980. 

Given the guest blog by "Harold DeMonaco, director of the Innovation Support Center at the Massachusetts General Hospital and one of Schwitzer's most active expert story reviewers on HealthNewsReview.org, my guess is he would be delighted to have stopped progress in it's track in 1980.  DeMarco said: "Can we afford to continue to pay for treatments that provide what many would call a marginal benefit? Can we afford not to? Although the increase in survival was only 4 months (from 21 months to 25 months), some men survived longer."

I am shocked at how uninformed the rant against Provenge and other medical breakthroughs was.   In 1980 the average cost for treating colon cancer was $20K, about $42K in 2010.  In 1980 the average five year survival rate for colorectal cancer was 50 percent for people age 45 and over among patients whose cancer had spread to lymph nodes  Today the average cost of colon cancer therapy is $40K with a 5 year survival rate  at a similar stage is 70 percent.  The age-adjusted death rate was 17.6 per 100,000 men and women per year. These rates are based on patients who died in 2003-2007 in the US.  

Advances in interceding years provided, as you described Provenge (which has extended the life expectancy of end stage prostate cancer patients by 2 years) marginal benefit.  That’s on top of a decline in mortality rates from previous treatments and increase screening.

David Cutler noted that “age-adjusted cancer mortality increased by 8 percent between 1971 and 1990, twice the increase from 1950 through 1971. However, between 1990 and 2004, age-adjusted cancer mortality fell by 13 percent. This drop translates into an increase in life expectancy at birth of half a year--roughly a quarter of the two-year increase in life expectancy over this time period and a third of the increase in life expectancy at age 45.”   Similarly,  Murphy and Topel estimate that a 1 percent reduction in cancer mortality would be worth $500 billion.  Since the death rate from prostate cancer has decline by 37 percent since 1992, the worth of that reduction is $18 trillion.

So would you not have spent more money on increasingly more expensive drugs because at that point in time the benefits were marginal. 

That begs the question: would he forfeit the gains in health derived by increased screening and better drugs over the past 30 years to buy more of the kind of cancer care we had in 1980.  Or his just willing to forfeit gains going forward. 

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The Human Cost of CER

05/10/2011 01:20 PM |

I will let Fox News' Jim Pinkerton who also runs the Serious Medicine Strategy blog introduce our new paper on the human cost of comparative effectiveness research:

Editor's Note: This is an important piece on Comparative Effectiveness Research from the Center for Medicine in the Public Interest, a leading voice in the struggle to improve our national health through the expansion of personal freedom and the advancement of Serious Medicine."
seriousmedicinestrategy.blogspot.com/



Our thanks to Jim Pinkerton for taking our research so..seriously!
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Mistaking Forest for the Sleaze

05/10/2011 01:10 PM |

The Obama Watch

Hard on Drug Execs, Soft on Dictators

By Robert M. Goldberg on 5.3.11 @ 6:07AM

I was in Israel for two weeks hearing nothing but how the Obama administration is tougher (in action and language) on Israel than it has been on the Muslim Brotherhood (the White House seder included a Tahrir Square   salad) and Syria's dictator Bashir al-Assad.

Now it turns out that Team O is tougher on drug company CEOs than it is on brutal dictators and a movement whose goal is wiping out Israel. The administration is applying a little used government approach to knee-capping executives it doesn't like by threatening that HHS won't allow Forest Laboratories to sell medications to Medicare, Medicaid, and other government health programs (which means every health plan under Obamacare) unless it tosses the company's CEO, Howard Solomon. According to news accounts, the action is being taken because government lawyers claim that just fining the company billions isn't stopping illegal behavior. But neither Mr. Solomon nor Forest has been found guilty of any wrongdoing. Here's the WSJ account:

The Health and Human Services department startled drug makers last year when the agency said it would start invoking a little-used administrative policy under the Social Security Act against pharmaceutical executives. This policy allows officials to bar corporate leaders from health-industry companies doing business with the government, if a drug company is guilty of criminal misconduct. The agency said a chief executive or other leader can be banned even if he or she had no knowledge of a company's criminal actions. Retaining a banned executive can trigger a company's exclusion from government business.

Can you imagine the administration using this tactic against health IT firms, unions, the New Black Panthers, ACORN, or investment banks?  For different reasons for each, the answer is "No."

Health IT firms are the favorite sons of HHS, the New Black Panthers, of municipal officials who milk pension funds and funnel money to their pet projects, unions are -- well enough said -- and investment banks would never be touched because that would trigger panic in the bond markets upon which the administration relies to finance the mounting debt. 

So picking on the CEO of a company that has already paid out $300 million in fines to avoid a government lawsuit regarding marketing practices makes political sense, even if Pharma supported Obamacare. My guess is that it will lead companies to be much less likely to make products available to government programs. Or maybe the administration will force sales at specific prices in exchange for a "promise" not to rough up CEOs. That is as close to government extortion as one can get. This, from an administration that promised to be more business friendly.

Meanwhile the threat against Forest and its CEO is more draconian than actions the Obama administration is taking against Assad. The dictator who has slaughtered his people, aided Iran, built a uranium-enrichment facility, staged the Hezbollah takeover of Lebanon, and whose country is soon to be part of the UN Human Rights Council has received a stern warning from the president but nothing more.

As for the administration's toothless response to Assad (well captured by the brilliant Barry Rubin), note how an administration official in quoted in the New York Times on these points:

Administration officials say that while they lack many effective economic tools, they believe Mr. Assad is sensitive to portrayals of his regime as brutal and backward. "He sees himself as a Westernized leader," one senior administration official said, "and we think he'll react if he believes he is being lumped in with brutal dictators."

Is this for real? How cannot one be sarcastic and hypercritical when leading U.S. officials think that a ruthless dictator -- in fact, the most cleverly ruthless dictator in the Arabic-speaking world -- really cares if people in the West say mean things about him."

The administration only picks on people and enterprises it can bully for show, without thinking through the consequences. Meanwhile it avoids taking on real evil or illegal activity when it suits the political goal of the moment and fits those naive narratives shaping the administration's actions. Forest and its CEO paid their debt in full. The effort to can Solomon is gangster government that serves a short-term political purpose while the administration's inaction towards Syria emboldens a chief executive of whom Rubin writes: 

It would be impossible to find someone more eager to be a brutal dictator and who does not see himself as a Westernized leader. If this were the "Godfather," Bashar would be Michael, not Fredo.

If the Obama Administration doesn't understand this, it understands nothing. Yes, that's the point. It understands nothing.

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And speaking of physician disempowerment ...

05/10/2011 09:01 AM |

A new survey released yesterday by the Massachusetts Medical Society reveals that fewer than half of the state's primary care practices are accepting new patients, down from 70% in 2007, before former Governor Mitt Romney's health-care plan came online. The average wait time for a routine checkup with an internist is 48 days. It takes 43 days to secure an appointment with a gastroenterologist for chronic heartburn, up from 36 last year, and 41 days to see an OB/GYN, up from 34 last year.

As the Wall Street Journal opines, “Combined with insurance regulations that suppress innovation and competition, this reality helps explain why Massachusetts premiums are among the highest in the U.S. The current physician shortage was inevitable without new doctors.”

Massachusetts health regulators also estimate that emergency room visits jumped 9% between 2004 and 2008, in part due to the lack of routine access to providers. The Romney-Obama theory was that if everyone is insured by the government, costs would fall by squeezing out uncompensated care. Yet emergency medicine accounts for only 2% of all national health spending.

Another notable finding in the Medical Society survey is the provider flight from government health care. Merely 43% of internists and 56% of family physicians accept Commonwealth Care, the heavily subsidized middle-class insurance program. The same respective figures are 53% and 62% for price-controlled Medicaid. Government health insurance may be great, but not if it can't buy actual health care.

The Medical Society also finds "a continued deterioration of the practice environment for physicians in Massachusetts."

Mitt happens.

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It's the economy, stupid

05/10/2011 08:33 AM |

From the pfolks at PhRMA, some interesting state and national data on biopharmaceutical economic contribution to the US economy.

Here’s an interactive map presenting state economic impact data. The data reflect analyses conducted by Archstone Consulting.

To see select thumbnail information, click on an individual state. Subsequent landing pages provide more detailed information, with links to two-page Archstone fact sheets, which include state-specific data on employment, economic output and research and development activity, as well as Battelle fact sheets on states’ efforts to attract and develop a local biosciences presence.

The U.S. fact sheet with national economic impact data is available here.

Now that's a stimulus package.

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When Provider is Payer “Bias” is in the Eyes of the Beholder

05/10/2011 08:23 AM |

According to a new survey, US doctors do not believe industry funding significantly biases their continuing medical education -- and they are unwilling to pay for “impartial sponsorship.”

Dr. Jeffrey Tabas, an emergency physician at the University of California, San Francisco, surveyed attendees at five CME courses delivered by the International AIDS Society-USA, which receives industry funding.

Less than half thought paying higher registration fees for CME activities would make sense and only 15 percent would like to see industry funding completely removed.

"Because they feel in general there is not a lot of bias, they are not willing to pay to reduce it," said Tabas.

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FOBs: Fee for Service

05/10/2011 08:21 AM |

Drugmakers seeking FDA approval for biosimilars will pay application fees similar to charges for brand-name medicines.

The Food and Drug Administration plans to break down the cost to review so-called biosimilars into separate payments with more money charged up front during development, according to a proposal released today. The fees will be assessed annually and followed by application charges, establishment and product fees required for all drugs.

 “Given that the approval pathway for biosimilar and interchangeable biological products is new, FDA services are most critical for continued and successful development of biosimilar and interchangeable biological products during the investigational stage prior to submission of a marketing application,” the agency said in its Federal Register notice.

The FDA’s proposal covers fiscal years 2013 to 2017, and comments will be accepted on the plan until June 9.

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