Social Disease

11/23/2010 09:28 AM |

From the pages of Medical Marketing & Media:

Patients taking a medication and looking online for health information tend to avoid pharmaceutical company sites, according to an online survey conducted by Accenture.

Just over two-thirds of surveyed respondents said they go online for health information, according to the data. Of that group, nearly half (48%) said they use medical websites like WebMD most often, and just 6% said they use social media sites like Facebook or Twitter most often for health information. Eleven percent of the respondents said they use a pharma company website most often – the same percentage that reported using an online community, like a disease-specific patient site, most often.

Tom Schwenger, global managing director for Accenture's Life Sciences sales and marketing practice, said he “acknowledges the regulatory hurdles that exist in two-way dialogue” between pharmaceutical companies and patients, but that “the gap between the hurdles and what we're seeing represents a large opportunity” for pharma marketers. “What's ironic is that industry cost pressures are greater than ever before, so it makes sense to reevaluate digital and online strategies” with respect to patient communications, said Schwenger.

The survey also found that 69% of respondents “expect pharmaceutical companies to provide information about an illness or condition,” and only 28% of respondents said they are more likely to ask their doctor about a drug after seeing an advertisement. However, 46% of respondents said drug ads increased their awareness of symptoms and possible treatments. Ten percent of respondents said their drug choice had been influenced by coupons, and 47% said it had not, but could be in the future, according to survey data.

The survey's sample was 852 adults in the US, and was conducted between August 30 and September 3, 2010.

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And those who can't teach, teach gym

11/23/2010 08:47 AM |

At a recent meeting of the Generic Pharmaceutical Association, CDER Director Janet Woodcock said that the FDA is discussing tightening the equivalence limits of generic medicines "so there is less variability.”

In April, the Pharmaceutical Science and Clinical Pharmacology Advisory Committee, voted 11-2 that the agency’s equivalence requirements aren’t’ sufficient for certain medicines. They didn’t offer an alternative, and suggested the FDA list “critical dose drugs or drugs where a small difference in concentration can change patients’ reaction, that may need new standards.

The Pharmaceutical Science and Clinical Pharmacology Advisory Committee voted unanimously, with one abstention, that critical dose drugs do constitute a distinct group and voted unanimously that FDA should develop a formal list of those drugs - although the terminology of "narrow therapeutic index" may be more appropriate. And in an 11-2 vote, the committee concluded that current bioequivalence standards are not sufficient for drugs in the narrow therapeutic index group.

Critical dose drugs have a narrow therapeutic index, meaning that "small changes in blood concentration have the potential to result in serious therapeutic failures and/or serious adverse drug reactions." FDA is consulting the committee on the need to establish separate bioequivalence criteria for these drugs given continuing debate about whether critical-dose drugs require special consideration, the agency explained.

(Currently, the "sameness" of a brand product and a generic version is evaluated based on two-treatment crossover study to prove bioequivalence, the aim being to show that the 90 percent confidence intervals of the geometric mean test/reference ratios for both maximum plasma concentration and the area under the plasma concentration-time curve fall within a range of 80 percent to 125 percent.)

Last month the FDA responded to a request from New Jersey State Senator Joseph Vitale concerning pending New Jersey state legislation that, if enacted, would require pharmacists to dispense epilepsy drugs from the same manufacturer as previously dispensed for certain patients, unless otherwise prescribed. 

In its response to Senator Vitale, FDA comments that “[t]o date, we have not seen any scientific evidence that demonstrates a problem with therapeutic equivalence for this group of products or any other class of generic drug products.  Those who are questioning the quality of generic epilepsy products have produced only anecdotal evidence.” 

And, further:

“[W]e believe that the concerns of some of those raising questions (in particular, physician groups) cannot be dismissed lightly.  Because of FDA’s respect for these groups and the concern that patients may lose confidence in their prescribed medications, we have sought to conduct further study.  Our decision to further study this issue does not stem from doubt within the agency about data we currently have on approved generic epilepsy products.  Rather, it is based on a desire to obtain further independent scientific evidence that might address these concerns.”

Condescending? I suppose it depends how you choose to read it. Does the agency really mean to dismiss the concerns of practicing physicians who see these problems first hand? Maybe PDUFA V funds should be earmarked for FDA staff to attend more neurology conferences to hear about the "scientific evidence” first hand.

More peculiar still is that such statements seem at total counterpoint to the comments of Dr. Woodcock and the unambiguous votes of the advisory committee.

This strikes a very personal note for me.  One of my sons has Juvenile Myoclonic Epilepsy.  His condition is wonderfully controlled via his meds – and I’d like it to stay that way.

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Vytorin Victory

11/22/2010 02:10 PM |

Recently a drug developed by Merck and Schering Plough was found to reduce arterial plaque, preventing angioplasty and stenting, as well as strokes in a study of 9000 patients with kidney disease and diabetes.  According to Merck's research czar Peter Kim: The SHARP (Study of Heart and Renal Protection) study showed that "the investigational use of the drug significantly reduced the risk of these events in a spectrum of patients with chronic kidney disease -- and this was the first demonstration that an LDL-cholesterol lowering medicine could do so."
So what was the response to this study?

"This drug doesn't work. Period. It just doesn't work," said Steven Nissen, head of cardiology at the Cleveland Clinic. U.S. Rep. Bart Stupak, a Michigan Democrat helping to lead a congressional investigation of the study, said, "It is easy to conclude that Merck and Schering-Plough intentionally sought to delay the release of this data." Investors voted with their feet, pushing Schering-Plough (nyse: SGP - news - people ) shares down 8% and Merck (nyse: MRK - news - people ) shares off 1%. "

www.forbes.com/2008/01/14/enhance-merck-schering-biz-healthcare-cx_mh_0115bizenhance.html

Oops that was 2008, when Nissen was leading the charge and making charges that a study about Vytorin was flawed and that the two companies were engaged in -- what else -- a coverup of the shoddy research and its conclusions.  At least that was the narrative shaping the stories from Matt Herper, Steve Nissen's Boswell...   Here is a laundry list of Matt's articles regarding the 'coverup' of the Vytorin debacle.

Sept. 3, 2008: Top Statistician Says Vytorin Cancer Risk 'Not Ruled Out'

May 19, 2008: Should Schering-Plough's Chief Give Back His Bonus?

April 15, 2008: Vytorin's Man In The Middle

March 30, 2008: Vytorin Backlash

March 25, 2008: More Questions About Vytorin Panel

March 21, 2008: Vytorin On Trial

Jan. 11, 2008: Inside Schering And Merck's Secret Panel

Nov. 19, 2007: The Vytorin Question

Herper went so far as to misconstrue Eric Topol's measured response to the study:  One person who won't be convinced by ENHANCE: Eric Topol, the noted chief of translational medicine at Scripps Health in La Jolla, Calif. He still wants to see clear data on how Zetia affects heart attacks, strokes and deaths, and doesn't understand why it took so long to embark on a big study to prove it. Doctors have been "hanging in suspense for years, unnecessarily," Topol says. "It's still conceivable there would be improvement in outcomes. Until we have that data, the jury is out."

Dr. Topol emphasized the need for a larger study with outcomes data.  The recent study about Vytorin is consistent with Topol's broader work on genomics and heart disease:

That driving down LDL alone is not sufficient for reducing the risk of stroke or invasive procedures in both primary care and high-risk populations.  Further, the mechanism by which Vytorin did achieve a reduction in plaque build up and stroke are still not completely clear.  LDL levels fell but it will be interesting to see how that decline is biologically linked with the clinical outcomes observed.  Finally,  linking hard clinical endpoints to reductions in plaque remains an exciting and interesting area of research in cardiology when paired with genomic research that can tailor treatments to populations with different forms of the disease.

And what did Nissen say about the SHARP results?  Matt Herper channel's him:

"Without a group of patients who received just Zocor, it’s impossible to determine whether Vytorin worked any better than Zocor would have alone, says Steven Nissen of the Cleveland Clinic, another critic of the drug. "blogs.forbes.com/matthewherper/2010/11/20/finally-a-win-for-vytorin/

But let's repeart what Peter Kim said:" the investigational use of the drug significantly reduced the risk of these events in a spectrum of patients with chronic kidney disease -- and this was the first demonstration that an LDL-cholesterol lowering medicine could do so."
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Disarming? Alarming.

11/22/2010 08:44 AM |

Anyone who has been diagnosed with cancer knows the importance of having an arsenal of therapeutic weaponry. So why are federal officials asking patients with advanced breast cancer to unilaterally disarm?

 

The weapon in jeopardy is Avastin, a biologic drug that cuts off the blood supply to tumors. Clinical studies prove that for women with stage 4 breast cancer, Avastin buys them weeks or months in which the cancer doesn't spread.

 

But the Food and Drug Administration isn't satisfied this time is “enough,” and will decide by Dec. 17 whether to revoke its approval of Avastin as a treatment for breast cancer.

 

Patients and their doctors have proclaimed they should decide what constitutes “enough.” Cancer treatment can't be one-size-fits-all. Some research has found, on average, Avastin doesn't prolong life. But scientists universally agree that it does prolong the quality of life. One study demonstrated that Avastin plus chemotherapy delayed tumor growth a median of about 11 months — five months longer than chemo alone.

 

Focusing only on averages ignores patients that are “super-responders.” Erin Howarth, was 31 when she learned her stage 4 breast cancer had spread to her spine, skull, pelvis and right leg.

 

“I got the impression that it was just like, ‘Well, you're going to come here for chemo every week . kind of until you die,'” Howarth told a newspaper.

 

But she sought out other doctors who put her on Avastin. Within seven months, her cancer was in remission. Labeling herself the poster child for Avastin, she concluded “it worked really well for me.”

 

Susan G. Komen for the Cure and Ovarian Cancer National Alliance wrote to the FDA urging them to preserve Avastin. They contended that removing it from the FDA's list of approved drugs for breast cancer could discourage future drug development.

 

Since the FDA fast-tracked approval of Avastin two years ago, it has been prescribed to about 17,500 patients a year with metastatic breast cancer.

This summer, a 13-member FDA advisory panel — with only two breast cancer oncologists — recommended that the FDA withdraw its approval of Avastin for breast cancer patients.

Doctors could still prescribe Avastin without FDA approval by going “off label.” But if the FDA revokes its breast cancer seal of approval for Avastin — insurance companies, Medicaid and Medicare are also likely to deny coverage.

 

The latest vote of confidence in Avastin comes from the National Comprehensive Cancer Network — a not-for-profit alliance of nearly two dozen of the world's top cancer centers. Last month, they announced it had reviewed and affirmed its guidelines for using Avastin to treat metastatic breast cancer.

 

The FDA should listen to these experts, and to patients. Avastin may well be the best weapon they've got to fight cancer — and the government shouldn't take it out of their hands.

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Mind the Gap

11/19/2010 08:00 AM |

Actions have consequences – often unintended ones.  And the same is true for inaction.

Remember the medical device “gap” of the 1990s?  That’s when Europe was outpacing the United States in bringing new medical technologies to market.  Well – the gap is back, it’s growing – and it has consequences.

The #1 consequence is that Americans don’t have access to new technologies that make a difference. It also means that American companies (and their investors) wonder whether continued investment in research and development is worth it. 

And what’s on the other side of the equation?  One would think, well, safety.  After all, nobody wants the FDA to approve unsafe medical technologies.  Sure enough.  But there’s no evidence that these newer options available in Europe are anything except safe and effective.  Hence, there is a gap in care but none is device safety.  What’s wrong with this picture?

All this while we debate reform to (among other things) the 510(k) process.  Reform?  Good.  Better?  Sure.  But we must also address the issues of better with faster. We must learn from Europe.  We must harmonize with Europe.  And we mustn’t ignore the reality that the medical technology gap is widening and that this fact has consequences for the public health in the United States today as well as for the competitiveness of the American medical technology industry in the future.

A new survey of medical technology companies and investors (by Josh Makower, MD Consulting Professor of Medicine, Stanford University; Aabed Meer MD-MBA, and Lyn Denend Research Associate, Stanford University – with support from the Medical Device Manufacturers Association, the National Venture Capital Association, and multiple state medical industry organizations) is important reading -- and not just for industry and investors, but for thought leaders and policy makers – and especially those at CDRH.

 

The full report can be found here.

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FDA inhales DDT

11/18/2010 10:05 AM |

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Berwick Plays Hide and Seek With GOP: Media Helps

11/17/2010 11:18 PM |

Don Berwick's coming out party was a little over an hour long.  He was shepherded and sheltered by Finance Committee Dems who ate up the clock with softball questions about how Obamacare repeal would affect seniors.  Berwick said disastrous without explaining how  stoping cuts in hospice care and Medicare advantage and using comparative effectiveness to delay access to breakthroughs like Provenge are harmful.  Republicans didn't even have enough time to clear their throats before the hearing was adjourned.

Berwick recycled comments he has made since the story about his love affair with rationing, centralized decisioning making and the NHS was broke by yours truly: He told the Committee seniors should get   "all the care they want and need, when and where they want and need it."

He didn't mention that what people want and need will be limited by what government defines as quality care. 

And he already broke his promise by delaying access to Provenge and rationing diabetes strips. 
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Explaining survival rates

11/17/2010 11:36 AM |

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Berwick Eats Humble Pie

11/16/2010 01:12 PM |

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Berwick’s Death Panel

11/16/2010 01:07 PM |

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Mommy, where do drugs come from?

11/16/2010 06:19 AM |

 Innovation?  Unmet needs?  Where's the action?

An interesting new paper by Robert Kneller (University of Tokyo, Research Center for Advanced Science and Technology) The importance of new companies for drug discovery: origins of a decade of new drugs.

Here’s the abstract:

 

Understanding the factors that promote drug innovation is important both for improvements in health care and for the future of organizations engaged in drug discovery research and development. By identifying the inventors of 252 new drugs approved by the US Food and Drug Administration from 1998 to 2007 and their places of work, and also classifying these drugs according to innovativeness, this study investigates the contribution of different types of organizations and regions to drug innovation during this period. The data indicate that drugs initially discovered in biotechnology companies or universities accounted for approximately half of the scientifically innovative drugs approved, as well as half of those that responded to unmet medical needs, although their contribution to the total number of new drugs was proportionately lower. The biotechnology companies were located mainly in the United States. This article presents a comprehensive analysis of these data and discusses potential contributing factors to the trends observed, with the aim of aiding efforts to promote drug innovation.

 

Some relevant facts:

        

* Of the 252 new drugs approved by the FDA from 1998 to 2007

o   58% from pharmaceutical companies

o   18% from biotech companies

o   16% from universities, transferred to biotech

o   8% from universities, transferred to pharma

 

* 123/252 (49%) new drugs approved by FDA from 1998 to 2007 were for an unmet medical need

 

* 118/252 (46%) new drugs approved by the FDA from 1998 to 2007 were scientifically novel

 

* 24/252 (21%) new drugs approved by the FDA from 1998 to 2007 had an orphan designation

 

The full paper can be found here.

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Paul Krugman: For Death Panels before he was against them

11/15/2010 12:39 PM |

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Drug Makers Brace for Possible Cuts to FDA

11/15/2010 10:25 AM |

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Quote of the week

11/12/2010 12:59 PM |

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CMPI at Columbus Circle

11/12/2010 12:54 PM |

CMPI at Columbus Circle from CMPI on Vimeo.

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MIT enjoying NEWDIGS "over there"

11/12/2010 08:21 AM |

The European Medicines Agency (EMA) and MIT’s Center for Biomedical Innovation (CBI) and Center for International Studies (CIS) are launching a collaborative research project with a focus on enhancing regulatory science in pharmaceuticals.

Specific questions addressed by this project include how to:

* adapt current regulatory requirements to support the efficient development of safe and effective drugs;

* incorporate patient valuation of health outcomes and benefit-risk preferences into regulatory decision-making;

* implement 'staggered' and 'progressive' approaches to drug approval;

* improve fulfillment of post-marketing regulatory requirements.

The project will explore the feasibility of, priorities for and practical considerations of implementing demonstration projects on some of the issues addressed during the course of the research.

Sound familiar? It's what the FDA's Critical Path program was designed to do -- that is until it hit Congressional treacle embodied by a certain member who will shortly lose her majority status.

The data and recommendations from this project are expected to link to implementation of the Agency's Roadmap to 2015 and the CBI's New Drug Development Paradigms (NEWDIGS) research program.

The project is scheduled to be completed by December 2011.

 Hopefully with a new chair at the helm of the House Agriculture (and FDA) Appropriations Committee, funding for the Reagan/Udall Center can be released and FDA can, once again, take a leadership role in developing the tools for 21^st century regulatory science.

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Remembering Our Veterans

11/11/2010 12:50 PM |

Reagan's D-Day Speech at Normandy Beach still resonates and recalls the courage mustered by everyday Americans to preserve freedom.




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Death rates in U.S. and England

11/11/2010 10:58 AM |

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A Tangled Webb

11/10/2010 10:48 AM |

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Long Time Companion (Diagnostics)

11/09/2010 08:33 AM |

Industry is anxiously awaiting guidance from FDA on the development of companion diagnostics for drugs that will inform efforts to move towards personalized medicine. The agency has vowed to release a draft guidance on companion diagnostics by the end of the year. But the initial document will address development of companion diagnostics for drugs already on the market, not simultaneous drug/diagnostic development for new drugs.

According to Vicki Seyfert-Margolis, FDA’s senior advisor for science innovation and policy:

“One challenge is that multiple centers have to be involved – CDRH and CDER/CBER. The challenge is internal to determine the mechanism for how the applications will come in and how the review is done. I think we are well on our way to figuring out that process between the different centers. With respect to how one designs and qualifies a diagnostic versus a clinical trial, the study design aspects are another challenge.”

“We are also concerned that we will have markers and use patient selection strategies in a clinical trial and then that marker may turn out to be a disease prognostication marker and you may have selected a set of patients that have different metabolisms. There are a myriad of possibilities one could think of that may or may not completely relate to the drug. We just have to be very thoughtful. I think we will evaluate a lot on a case-by-case basis, but we are trying to at least get some information out about what the paths are.”

And then there’s the issue of the “open kimono.”

Ms. Seyfert-Margolis: “One thing I think would be a big win in helping drive personalized medicine and co-development and companion diagnostics will be to open the data. We need to open the data in-house and also strive to get industry to be more transparent and work with us on this. If we took rheumatoid arthritis, for example, and looked across all the trials that have been done with TNF-alphas and evaluated who are the true responders, who are the non-responders, is there anything we can find in all that data that might point to some marker or some diagnostic that could be used, then we could begin to get at least hints about things that could open up new scientific areas for predictive diagnostics.

Amen.  Sounds like a good way to involve the Reagan/Udall Foundation.

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