Blood Simple

01/03/2011 08:30 AM |

Okay, maybe not so simple -- but certainly exciting.

Researchers at Massachusetts General Hospital have already developed a prototype of a microchip that can detect tumor cells at extremely low levels in the bloodstream. The effort to be announced today intends to draw on the expertise of scientists familiar with how to bring such technologies to patients and doctors.

By detecting cancer cells through a blood test, doctors could better follow the disease’s course — looking to see whether the level of cancer cells circulating drops with treatment. It would also allow doctors to test the genetics of the cancer cells, considered by doctors to be critical because many cancer drugs are targeted treatments that work against a cancer with a particular mutation.

To detect the extremely rare cells, the new technology uses minuscule channels carved into a silicon chip, coated with a special glue-like substance. When the blood filters through the channels the technology is able to pick up, on average, about 10 cancer cells per milliliter of blood in patients with metastatic cancer, disease that has spread from a primary tumor to other parts of the body.

But will payers pay for it? Early diagnosis means earlier treatment and better chances for prolonged survival.  Good for patients. But will payers (and particularly Uncle Sam, MD) see it that way?

  Read More & Comment...

Einstein at the FDA

12/31/2010 11:11 AM |

From today’s Wall Street Journal:

FDA spokeswoman Sandy Walsh said there's "no systemic change in how the FDA is approaching drug approvals."

From Albert Einstein:

Insanity: doing the same thing over and over again and expecting different results.

And onwards to PDUFA V.

  Read More & Comment...

Two Wrongs

12/30/2010 09:42 AM |

Hyperbole and misdirection aren’t going to solve the problem of the slippery slope towards government-run health care – it’s going to hasten it. 

No – not “death panels” (although this Palinian shibboleth certainly falls into this category) but rather statements to the effect that the FDA’s decision to remove Avastin’s breast cancer indication was “a crude cost calculation.”  Not true. Not helpful.

In today’s Wall Street Journal, David Rivkin and Elizabeth Foley write that, “The FDA made a crude cost calculation; as everyone in Washington knows, it wouldn't have banned Avastin if the drug cost only $1,000 a year, instead of $90,000.”

“Everyone?” Not really.  For those who understand what actually goes on at the Food & Drug Administration it’s not about “cost” as much as it is about “choice.” And on that note Rivkin and Foley get it right:

 

“The Avastin story is emblematic of the government's broader agenda to ration care based on cost and politics. Once ObamaCare comes into full force, such rationing will be pervasive. When the government sees insufficient benefit, all but the wealthiest and most politically connected will have to go without.”

 

We are being railroaded down the tracks towards Uncle Sam, MD – but the FDA’s ruling on Avastin (whether you agree with it or not) was based on the agency’s reading of the science.  Trying to tag the FDA with a decision based on cost may be convenient – but it’s wrong.

 

Such hasty proclamations trivialize the urgent and legitimate arguments against the current cost-versus-care direction of American health care – and makes it all the more difficult to counter and correct.  Read More & Comment...

Black Ops

12/29/2010 09:09 AM |

Per the new HHS regulation that pays for “voluntary” end-of-life counseling as part of seniors' annual physicals – just what makes it voluntary?  Does a person need to ask for it? Will there be a discussion guide?  If so, who will prepare the talking points? When are such conversations "appropriate?" And since physicians are being incentivized to provide this service, where are the "best practice" guidelines? These are only a few of many unanswered questions.

 

The Wall Street Journal reports that:

 

The office of Oregon Democrat Earl Blumenauer, the author of the original rider who then lobbied Medicare to cover the service, sent an email to supporters cheering this "victory" but asked that they not tell anyone for fear of perpetuating "the 'death panel' myth." The email added that "Thus far, it seems that no press or blogs have discovered it, but we will be keeping a close watch.

So much for embracing transparency. “The regulatory process,” the WSJ opines, “isn't supposed to be a black-ops exercise.”
 

The Journal continues,

 

The affront is that Medicare needs to sneak around in order to offer a type of care that is routine in private insurance. If the medical experts in Congress haven't decided that some treatment or service is worthy of the fee schedule, then the program won't pay for it even if it is in the best interests of patients.

Under highly centralized national health care, the government inevitably makes cost-minded judgments about what types of care are "best" for society at large, and the standardized treatments it prescribes inevitably steal life-saving options from individual patients.

 

Set your TiVo for CSPAN.  Read More & Comment...

90 miles to a longer life

12/28/2010 07:21 PM |

  Read More & Comment...

When is Science not Science?

12/28/2010 08:05 AM |

When is science not science?  When it's social science.

DDMAC is conducting a study of how consumers and physicians understand the information in print ads and drug labels.  But it’s got a fatal flaw – it’s not double blind.

 

In comments on the proposed study design, Merck suggested removing statements from the draft physician questionnaire that the drug is fictitious on the grounds that this might bias the results and instead label it a "potentially new drug." FDA rejected this idea for physicians, though it agreed to a bit of deception on the consumer questionnaire. And they’re right. Alas, the FDA disagrees.

 

"FDA had many internal discussions regarding this issue and decided that because of the particular [physician] sample, it is necessary to be upfront with them about the nature of the drug," the agency states in a notice scheduled to be published in the Federal Register on Dec. 23.

 

"Physicians will be more savvy about the particulars of the chemical entities and the realism of the clinical benefits and we do not wish to make them skeptical of our purposes," FDA states. "We agree that this approach is preferable for consumers and so we will inform them that this is a potentially new drug in that part of the study."

 

The consumer survey will present identical safety information under one of two randomly chosen headlines - "Important Safety Information" or "Important Risk Information" - to see whether that makes a difference in the respondents' understanding.

 

General practitioners will be asked to look at a label for one of the fictitious drug and answer questions designed to show how they use the prescribing information - which sections of the label they choose to read, for how long, and in what order. They will be asked how they perceive the drug's efficacy and how well they can recall the claimed benefits, and their answers will be compared with those of the consumers.

 

In other words, the GPs will know this is a test.  Isn’t it likely then, that they will pay closer attention to the details? Isn't it just as important to learn how much (or how little) physicians really understand the information presented in the P.I.? In fact -- isn't it more important since they are the "learned intermediaries?"

 

Comments from Eli Lilly & Co. suggested that benefits and risks be viewed  together and in a similar format so as not to bias the results. FDA agreed that "the benefits and risks should be evaluated together and [we] have several measures to investigate both. ...[but] because of the complexity of DTC ads, we cannot manipulate both benefits and risks at the same time."

 

Hm.

  Read More & Comment...

Burying the Lead

12/27/2010 09:21 AM |

During the Blizzard of Boxing Day, the New York Times editorialized on the FDA's decision to remove Avastin's indication for breast cancer. The Gray Lady was mostly supportive and neglected to say that many breast cancer organizations (including the Susan B. Komen Foundation) strongly believe that the agency made the wrong decision.

Alas, the editorial buried the lead in the final paragraph:

"Genentech plans to request a hearing with the F.D.A. to argue the case for retaining Avastin’s status as an approved breast cancer treatment. It should focus on proposing ways to identify the subset of women who can really benefit from Avastin."

The full editorial can be found here.

Burying the lead is one thing.  Prematurely burying patients is something altogether different.

  Read More & Comment...

Safety, Security & Supply

12/27/2010 09:09 AM |

A Double Edged Sword for U.S. Healthcare

By Paul Howard

  Read More & Comment...

Tevi’s words of wisdom

12/23/2010 04:27 PM |

  Read More & Comment...

Pharmville

12/23/2010 09:07 AM |

Drug Industry Dismayed by FDA Delay on Digital Marketing Guidelines

Three-Month Pushback Frustrates Industry Digging into Social Media and Internet Advertising

By Rich Thomaselli

NEW YORK (AdAge.com) -- The Food and Drug Administration just dropped a lump of coal in the pharmaceutical industry's stocking. The FDA has delayed its much-anticipated regulatory guidance for digital pharma marketing until the first quarter of 2011, further frustrating an industry eager to broaden its scope of internet and social-media marketing.

The agency released a statement Tuesday night to the EyeonFDA blog that read: "The Division of Drug Marketing, Advertising and Communications (DDMAC) has been researching draft-guidance topics on the following issues related to internet/social-media promotion of FDA-regulated medical products: Responding to unsolicited requests; fulfilling regulatory requirements when using tools associated with space limitations; fulfilling post-marketing submission requirements; online communications for which manufacturers, packers or distributors are accountable; use of links on the internet; correcting misinformation."

It continued: "Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements."

The FDA was expected to announce online guidelines by the end of this year after holding two-day public hearings in November of 2009. Delaying that potentially for three more months -- and guaranteeing draft guidance on only one of those topics -- is not sitting well. "It's infuriating," said one health-care-centric ad agency president. "On one hand, you want FDA to get it right. On the other hand, the (public hearings) were last November. They've had more than a year to get it right. It's bullshit."

But Paul Machado, CEO and founder of New Jersey-based Health Innovation Partners, said the delay is not such a bad thing. "If you think about it from the FDA's perspective and the challenges they're dealing with regarding health-care reform, why come out with a position? There's not a need right now. Why bother?"

Mr. Machado added that the industry will "continue to meander through the forest and see what happens, be conservative, see what others do and slowly create a position for themselves. Even if they do come out with guidance, it will take companies a long time to react to it. The reality is, you can only do so much anyway. "

At the November 2009 hearings, more than 60 people spoke, including representatives from Google, drug-makers and ad agencies. A month later the FDA published its Guidance Agenda for 2010, and the "Guidance on the Internet and Social Media" was listed -- meaning, at some point this year, the FDA expected to issue those guidelines.

One of the first inklings that it was going to be delayed came earlier this month when the FDA issued its Guidance Agenda for 2011 and "Guidance on the Internet and Social Media" was again listed.

Asked in an email why the agency would delay its online guidance, former FDA associate commissioner Peter Pitts replied: "Lack of knowledge. Lack of urgency. First Amendment angst."

Ironically, as the pharmaceutical industry itself begs for online/social-media guidance in order to pursue marketing in the new media, the first documented enforcement letter stemming from the FDA's new "Bad Ad" program was online-related.

The Dec. 3 letter from the Division of Drug Marketing, Advertising and Communications (DDMAC) to Hill Dermaceuticals claimed the company's web pages for its Derma-Smoothe product "are false or misleading because they omit and minimize the risks associated with the use of Derma-Smoothe Body Oil, overstate its efficacy, present unsubstantiated superiority claims, broaden and inadequately communicate the indication, and present unsubstantiated claims for the drug product. Thus, the webpages misbrand the drug in violation of the Federal Food, Drug and Cosmetic Act."

The "Bad Ad Program," instituted in May, urges the medical community to report ads and sales pitches that violate FDA rules. Ostensibly, the program was designed primarily to catch what the FDA can't see -- the behind-office-doors pitches from pharmaceutical sales reps to physicians. But the broad definition of the program allows doctors and medical professionals to report false or misleading ads to the FDA, and to do so anonymously.  Read More & Comment...

Wednesday reading

12/22/2010 11:18 AM |

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From the Day Late/Dollar Short Dep't

12/22/2010 09:15 AM |

Rep. John Dingell (D-Mich.) and three co-sponsors introduced the Drug Safety Enhancement Act (H.R. 6543), which seeks to enhance FDA's authority to regulate drug safety. The bill would create a registry of domestic and foreign drug facilities; generate funding for increased GMP inspections; provide FDA with mandatory drug recall authority and increased civil and criminal penalties; and require identification numbers for drug establishments and importers. The bill was co-sponsored by Rep. Henry Waxman (D- Calif.), Rep. Frank Pallone (D- N.J.) and Rep. Bart Stupak (D- Mich.).
  Read More & Comment...

Seeking (social media) Guidance

12/21/2010 03:35 PM |

The FDA will not be issuing a guidance on social media any time soon on any of the following:

• Responding to unsolicited requests
• Fulfilling regulatory requirements when using tools associated with space limitations
• Fulfilling post-marketing submission requirements
• On-line communications for which manufacturers, packers, or distributors are accountable
• Use of links on the Internet
• Correcting misinformation

The FDA goes on to say:

Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements.

My colleague Peter Pitts has written smartly on the subject of social media. If you read between the lines of the non-issuance,  Peter's prior observation that there is a lot that the FDA will and cannot regulate suggests that any guidance will be a non-event.

Beside,  as I point out in my book tabloidmedicine,  most of what defines the risk and benefits of a medicine on line is a result of what others are saying or spreading in ways that will always be unregulated by the FDA.   So what's a company to do? 

1.Fill the void with tools that give consumers information and the ability to determine in partnership with their physicians what's best. 
2. Ask people to volunteer participating in certain social networks,  only ask and enter when invited. 
3.  Respond quickly and proactively to scaremongering,  counterfeiting scams and hype. 

If companies wait for the FDA to define the online environment it will already be too late. Guidance should come from within (and not just from the legal department!).
  Read More & Comment...

Patients are a virtue

12/21/2010 09:12 AM |

Here’s a significant potential PDUFA addition – adding patient perspectives to the FDA’s analyses of drug application reviews.

 

In the minutes of the 11/22 PDUFA negotiating session, the FDA said that information about patients’ understanding of existing treatment tools is considered valuable, but is not consistently available during the review process.

This new initiative would place in front of frontline reviewers the views of patients who, for example, are willing to live with more serious side effects or safety concerns because they have failed on previous treatments and have no other options.

 

The agency said it wants to host meetings with review divisions and relevant patient advocacy groups to talk about available treatment options and unmet needs. That information would be used to help draft guidances for specific indications.

 

This is a real advance and will significantly enhance the role of the FDA’s Office of Special Health Issues. Bravo.

 

And speaking of greater input, industry is keen to bring more clarity and transparency to the approval process. Specifically, industry officials want a more structured risk-benefit formula included in PDUFA V and asked that the agency begin using it in its decision-making (similar efforts under way at the EMA).

 

CDER Director Janet Woodcock, “We’re all for that and we’ve been working on that, the industry’s been working on that, other academic parties have been working on that. So I think we will come up with something there.”

 

Office of New Drugs Director John Jenkins has said on more than one occasion that the framework should be simple and support sound expert judgment, not replace it.

 

According to Jenkins, such a model could improve predictability and consistency, support more structured discussions and provide concise descriptions of evidence and the risk-benefit implications.

 

Amen.

It's time to see all these good words turned into legislative deeds.  And the sooner the better.

  Read More & Comment...

PDUFA Agonistes

12/20/2010 09:32 AM |

A few thoughts on PDUFA V before we settle in for the holiday break.

Two Teams.  As negotiations proceed, it becomes increasingly obvious there’s an emerging duality – the FDA’s Part B “asks” and industry’s legitimate worries over what was promised, but not delivered, from PDUFA IV.

Perhaps both agency and industry should create two teams so that both sets of issues can be addressed in a timely and comprehensive manner.  Special teams, as they say, win ballgames.

Carrots and Sticks. Everyone wants to be rewarded for promises delivered – but perhaps its time for some hurt to be written into the system for promises unfulfilled.  PDUFA is a partnership and partnerships are built on mutual respect and understanding.  When one side rewrites the rules while the game is in play, that’s not partnership – it’s a thorny thicket of unintended consequences. Not to put too fine a point on it, but predictable timing for first cycle decisions count.

When the agency can “stop the clock,” PDUFA dates lose all meaning.  It’s the same argument used in Inherit the Wind to dispute the length of Earth’s “first day.” After all, since the Sun hadn’t been created yet, the first day could have been 24 hours or 24 billion years long. Sometimes a review feels just like that.

And finally …

First Principles.  It’s time to remember why PDUFA exists in the first place. And that reason is predictability. PDUFA V will either provide more predictability or more excuses.  The latter is not an acceptable choice for industry – nor will it be tolerated by the 112th Congress.

For all concerned – and particularly for patients – PDUFA V needs more resonant cowbell.

  Read More & Comment...

Back from Israel

12/19/2010 12:19 PM |

I arrived days after horrible fires in the Carmel forest and in the thick of two days of the worst wind storm in the history of the Jewish state.  Power was lost and quickly restored with typical Israeli aplomb and matter of factness.   Then (when I wasn't shopping with my son Zach) I participated in the Fourth Annual Health Care Technological Innovation program for Israeli life science entrepreneurs along with CMPI board members Gad Berdugo and Steve Sammut and former FDA official, all around great guy Dan Schultz and this year's CMPI Odyssey Award winner, Frank Douglas. The takeaway from the meeting: precompetitive collaboration, personalized medicine and the enduring value of innovation, even in the face of a complex FDA regulatory environment.  Frank and I went to the National Institute for Biotechnology of the Negev for a two hour presentation that demonstrated again Israel's astonishing contribution to personalized and predictive medicine.  From Tel Aviv and back I learned more about commercialization and innovation from Frank Douglas than I had in the past decade. 

I was also pleased to have my book Tabloid Medicine launched and want to thank Peter, Dr. Weber, Mario and Ben for their support!  Here's my observation on the new google.com 3-D body browser

www.technewsworld.com/story/Google-Really-Gets-Under-Peoples-Skin-71487.html

tabloidmedicine.com
  Read More & Comment...

Make Mine a Cuba Libre

12/18/2010 11:46 AM |

Proving once again that Moore is Less.

WikiLeaks: Cuba banned Sicko for depicting 'mythical' healthcare system
 
Authorities feared footage of gleaming hospital in Michael Moore's Oscar-nominated film would provoke a popular backlash
 
By Amelia Hill
guardian.co.uk, Friday 17 December 2010
 
A WikiLeaks cable reveals that when Michael Moore's film was shown to Cuban doctors, they were 'disturbed at the blatant misrepresentation of healthcare in Cuba'.
 
Cuba banned Michael Moore's 2007 documentary, Sicko, because it painted such a "mythically" favourable picture of Cuba's healthcare system that the authorities feared it could lead to a "popular backlash", according to US diplomats in Havana.
 
The revelation, contained in a confidential US embassy cable released by WikiLeaks , is surprising, given that the film attempted to discredit the US healthcare system by highlighting what it claimed was the excellence of the Cuban system.
 
But the memo reveals that when the film was shown to a group of Cuban doctors, some became so "disturbed at the blatant misrepresentation of healthcare in Cuba that they left the room".
 
Castro's government apparently went on to ban the film because, the leaked cable claims, it "knows the film is a myth and does not want to risk a popular backlash by showing to Cubans facilities that are clearly not available to the vast majority of them."
 
Sicko investigated healthcare in the US by comparing the for-profit, non-universal US system with the non-profit universal health care systems of other countries, including Cuba, France and the UK.

It was nominated for an Oscar for best documentary feature but was also castigated for being naive and tendentious.

The cable comes from the United States Interests Section in Havana (USINT) – staffed by US foreign service personnel and local staff employed by the department of state, the unit is formally a section of the Embassy of Switzerland, although it operates independently of the Swiss in virtually all but protocol respects.

The secret 2008 cable is based on reports from the USINT's foreign service health practitioner (FSHP) of her conversations with local people, unauthorised visits to Cuban hospitals, and experience of helping USINT American and Cuban personnel access healthcare.

The cable describes a visit made by the FSHP to the Hermanos Ameijeiras hospital in October 2007. Built in 1982, the newly renovated hospital was used in Michael Moore's film as evidence of the high-quality of healthcare available to all Cubans.
 
But according to the FSHP, the only way a Cuban can get access to the hospital is through a bribe or contacts inside the hospital administration. "Cubans are reportedly very resentful that the best hospital in Havana is 'off-limits' to them," the memo reveals.

According to the FSHP, a more "accurate" view of the healthcare experience of Cubans can be seen at the Calixto Garcia Hospital. "FSHP believes that if Michael Moore really wanted the 'same care as local Cubans', this is where he should have gone," the cable states.
 
A 2007 visit by the FSHP to this "dilapidated" hospital, built in the 1800s, was "reminiscent of a scene from some of the poorest countries in the world," the cable adds.
 
The memo points out that even the Cuban ruling elite leave Cuba when they need medical care. Fidel Castro, for example, brought in a Spanish doctor during his health crisis in 2006. The vice-minister of health, Abelardo Ramirez, went to France for gastric cancer surgery. The neurosurgeon whoheads CIMEQ [Centro de Investigaciones Médico-Quirúrgicas] hospital – widely regarded as one of the best in Cuba – came to England for eye surgery, returning periodically for checkups.
 
"After living in Cuba for two and a half years, treating numerous Cuban employees at USINT, and interacting with many other Cubans, the FSHP believes … preventive medicine in Cuba is a by-gone ideal, rather than the standard practice of care," the memo concludes.
 
* On his website today Michael Moore has said that Cuba did not ban his documentary, Sicko
 
  Read More & Comment...

A Healthcare Carol

12/17/2010 01:51 PM |

Some thoughts from the Ghost of Healthcares Yet to Come.

What business are you in?  To most people, including most of your industry colleagues, you are in the business of selling.  To survive and thrive you must be in the business of advancing the public health.  And to do that you must be seen as both teacher and expert.

And partner.

Partner with physicians, certainly.  With patients, definitely.  But also with government.  You must walk the tenuous tight rope of being both regulated entity and public health colleague with the regulatory mandarins who watch over you.

Your internal legal and regulatory departments will gasp.  But you will gain.  And it can (indeed must!) be done.

As ever greater regulatory oversight for your marketing practices comes into play across the globe, you must rethink both the type and timeframe for successful communications.  Rather than focusing strictly on short-term product sales programs, you must now create a firm foundation for trust built on the substrate of public health progams.

Consider the FDA’s “Safe Use” initiative.  In addition to adverse event reporting, the FDA wants to communicate with physicians and patients about how drugs and devices can be used safely, appropriately.  Because a product used safely is a safer product.  But the FDA needs allies.  It has no budget for public health outreach beyond the bully pulpit.  Who will step up to the plate to work with the agency?  What are the perceived barriers that you face in doing so?  If you want the agency to be both regulator and colleague, so too must you be prepared to play those identical roles.  It takes two to tango.

Similarly in the EU, the rules are changing when it comes to the Brussels concept of Information to Patients (ITP).  Consider this verbiage from a recent report from the EU Parliament:

“Member States authorities may not be in a position to fully address patients’ needs in terms of the substance of information and the access via different means … The pharmaceutical industry has the potential to be an important source of information to respond to the growing demand for more and better information by patients and to help reduce the current information gap, provided that there will be adequate rules to ensure reliability, objectivity, and quality of information.”

We are running out of failed 20^th century marketing alternatives.  It’s time to embrace public health communication programs as a powerful tool for corporate reputation, payer relations, physician education, patient empowerment, and yes – product sales.

But this strategy also requires a new appreciation of time.  No longer can you only design programs for short-term unit sales purposes.  That only reinforces your perception as greedy marketer.  The 21^st century demands a new paradigm.  It won’t be easy.  And it can’t be achieved through lip service.  You can’t talk yourself out of something you acted your way into.

The roadside of healthcare sales strategy is strewn with the carcasses of failed marketing alternatives.  Advancing the public health in concert with the governments with whom you do business is not only the right thing to do – it’s the smart thing as well.

  Read More & Comment...

A metastatic decision

12/17/2010 08:47 AM |

I do not believe that the FDA took cost into consideration in its decision to remove Avastin’s breast cancer indication.  Nevertheless, the unintended consequences are going to be deadly.

Medical decisions need to be left to patients and their doctors. They're the ones with access to crucial information needed to make the right decision about treatment options. Conceiving of medicine as one-size-fits-all is dangerous and ignores the individual biological nuances inherent in the U.S. patient population.

Of course, doctors could still provide Avastin for breast cancer treatment by prescribing it "off label." But an FDA denial means that public insurance programs like Medicaid and Medicare could refuse pay for the drug. Private plans would almost certainly follow suit.

In fact, evidence suggests that insurance companies are rooting for the FDA to de-list Avastin for advanced breast cancer. Already, the Regence Group, a regional health insurer in the Pacific Northwest, has published a policy listing Avastin for breast cancer as "medically unnecessary." And this policy was applied retroactively!

Without insurance coverage, patients would have to bear the full brunt of Avastin's price tag, which typically runs about $8,000 a month. Technically, women would still have access to this life-saving medication. But the only ones who will actually get to use it are the very slim minority with great financial means.

Worse still, revoking Avastin's approval would stifle medical innovation. Virtually every oncologist believes that the future of cancer treatment lies in complex, biologic drugs like Avastin. These kinds of drugs differ from traditional treatments in that they can be hypercustomized to meet the specific medical needs of individual patients. They also tend to be more effective.

By revoking Avastin's approval, the FDA would effectively eradicate the financial incentive for drug companies to develop advanced treatments like it. We'd lose out on an entire generation of cures.

  Read More & Comment...

Hoosier Daddy

12/17/2010 08:39 AM |

Eli Lilly & Co. President and CEO John Lechleiter was the sole representative of the biopharmaceutical industry at President Obama's Wednesday meeting with business leaders on how to encourage U.S. job growth and economic recovery.

During the meeting, Lechleiter discussed the "life sciences innovation hub" that has grown up in Lilly's home state of Indiana as a potential model for promoting innovation across the country, according to a company statement.

Let’s pick up on that theme and strive to make the 2011 health care discussion all about innovation – because that’s what it really is all about.  Read More & Comment...