CER Sucks More $$ From Innovation

08/09/2011 10:04 PM |

Drug Companies Spend an Average $13,000 per Patient on Comparative Effectiveness Research in Phase IV

RESEARCH TRIANGLE PARK, NC -- (Marketwire) -- 08/09/11 -- The cost of running a comparative effectiveness trial is $13,087 per patient during Phase IV, according to a study by Cutting Edge Information.

Comparative Effectiveness Research (CER) compares drugs, devices or other medical tests and procedures to determine the most effective outcomes for patient populations. Drug companies often use CER studies to compare their products head-to-head against competitors. The study found that CER studies make up the second largest portion of the average Phase IV development program, at 29%. Data generated from CER studies can prove invaluable. Favorable results from a registered Phase IV comparator trial is a powerful marketing and sales tool and can eventually alter disease treatment patterns.

Cutting Edge Information's study, "Phase IV Clinical Trials: Best Practices in Post-Marketing Study Management," found that in the U.S., CER studies typically cost drug companies $14,924 per patient. But companies that conduct these studies in Europe can see a substantial savings. According to the research, European CER studies run an average $9,873 per patient.

"Comparative effectiveness research studies are some of the more costly Phase IV trials that companies can invest in," said David Richardson, research team leader at Cutting Edge Information. "They can also prove risky for companies when their drugs don't compare favorably. However, the risks may be worth the gamble as product teams face reimbursement challenges by payers who are unwilling to cover more costly treatments for unclear patient benefit."

CER presents an opportunity for drug companies to prove that their products are not only more effective than their competitors, but could also prove better patient outcomes -- such as longer life spans -- and more cost-effective in the long run.

"Phase IV Clinical Trials: Best Practices in Post-Marketing Study Management," available at http://www.cuttingedgeinfo.com/research/medical-affairs/phase-iv-clinical-trials/, contains per-patient cost benchmarks on comparative effectiveness studies, patients-per-site, patients-per-investigator and other key metrics for five types of Phase IV studies. It includes metrics covering the U.S. and Europe as well as major therapeutic areas.

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Open (Label) and Shut Case

08/09/2011 09:52 AM |

On July 5^th,  Eli Lilly, Johnson & Johnson, Novartis, Novo Nordisk, Pfizer, and Sanofi-Aventis filed a Citizen Petition with the FDA asking the agency to clarify its policies on how truthful, non-misleading scientific information not included in approved product labeling can be communicated.

 

According to the petition, communicating accurate scientific information about new research would enhance health care quality and potentially lead to better patient outcomes, but that companies lack precise guidance on how to communicate such information.

“Scientific exchange,” broadly defined, is the sharing of research and clinical information about investigational medical products or new information on approved products without representing the product as safe and effective for that use.  FDA said in a 1963 regulation that it does not intend to restrict “scientific exchange.”  The concept of “scientific exchange” however, is not precisely described in FDA’s regulations and therefore leaves ambiguity about the limits of what is permitted.

 

We now have, thanks to those wonderfolks at DDMAC, some clarity when it comes to one kind of scientific exhange – open label trials.

 

DDMAC has cited Nycomed for a flashcard that based many of its claims on articles that “describe the preliminary and follow-up efficacy results of an uncontrolled, open-label study in patients with actinic keratoses."

 

"Results from a single open-label trial with no control group do not constitute substantial evidence or substantial clinical experience to support these, or any other, efficacy claims," DDMAC said, referring to graphs purporting to show how effective Solaraze is at "clearance of target lesions" of actinic keratoses.

 

This study also was not acceptable as a basis for a claim about the effectiveness of Solaraze in treating subclinical lesions, the letter adds. The company also cited an open-label study - it is unclear whether it was the same one - to claim that "the majority of patients were compliant with treatment," which also was unacceptable, according to DDMAC.

 

DDMAC has sent several sponsors (Arbor Pharmaceuticals, Hill Dermaceuticals, AMAG Pharmaceuticals) letters recently making it clear that open-label trials are not considered to be acceptable evidence of clinical efficacy.

 

 

You ask for clarity.  You get clarity. 

 

For a change.

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Provenge: Poster Child For An Age of Decline?

08/08/2011 05:42 PM |

I have read several articles and posts about the how the use of Provenge -  the first vaccine to delay prostate cancer -- is well below expectations.   Most of the discussion surrounds whether the slow adoption of Provenge is a function of the company not being ready to roll and work with doctors to get reimbursement for the vaccine or whether doctors are finding the effort to get approval for the use of Provenge and getting paid for it, worth the hassle and expense. 

If you compare Provenge to a Benlysta, the first new treatment for lupus in 50 years, you can't help but conclude that the beating Provenge took and the uncertainty that swirls around it's reimbursement still -- some might call it fear -- is so significant among community doctors that even the best sales force couldn't ovecome it.   Benlysta was approved in March of 2011 and HHS issued a reimbursement code for the drug July 1.    Provenge not only took a year, it was the subject of a Medicare technology review committee hearing.   A big part of the difference is the beating Provenge took at the hands of Medicare and anti-innovation types.

Is Provenge a harbinger of how innovation will be handled?  I don't have the answer to that.  But there is a dramatic disconnect between what scientists are discovering and the ethos of most of the rent-seeking companies, regulators, health plans administrators, Commonwealth Fund/Soros funded researchers, etc.  That ethos is organized what Aaron Wildavsky called "radical eqalitarianiasm:"  the belief in the moral virtue of equalizing differences.  Medical innovation is regarded as a source of inequality:  the less we spend on new cancer drugs, the more we can spend on healthcare entitlements. 

The contributions of medical technology are denigrated and the harms of innovations --  cancer, heart attacks, autism --  as part of a narrative depicting commercialization of science as a corrupt and corrupting enterprise the place profits above people.  The healthcare stakeholders by and large are consumed with finding fault, imposing the precautionary principle, holding up each and every innovation to the benchmark of comparative effectiveness or tort action.   They view innovation as a source or vector for inequality or injustice and treat marketing of any form as a potential criminal activity.  And hence they regard all new technologies as expensive, potentially dangerous, while adding a teardrop of benefit to society at an enormous cost. 

The prevailing cultural view of "the stakeholders" towards innovation is one of deep hostility.   Opposing views of the relationship between humanity and medical innovation are hardly heard and barely represented.  When they are, those who regard commercialization as inherently corrupt and regard themselves as the annointed visionaries who know what is best for the rest of us, invoke the canard of conflict of interest.  

The radicals claim innovation won't wither because of requlation, it will only make companies more 'competitive.'     In one sense they are right.  Venture capital and IPO financing for medical technology and life science companies are at all time highs -- in China.   That may be part of the effort to respond to the growing demand for healthcare services in emerging markets.   But in China, new biotech and medical device companies are welcomed instead being treated as criminals or obstacles to human progress.

The gauntlet Provenge had to run through is a product of that hostility.   And there's more to come.




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The Bully Pulpit

08/08/2011 08:05 AM |

Witness the prescient wisdom of Ralph Waldo Emerson who wrote, “Democracy becomes a government of bullies tempered by editors.”

Now consider the story of HHS v. Forest Laboratories.

When the Wall Street Journal pointed out the utter outrageousness of HHS threat of debarring Forest Labs CEO Harold Solomon (Kathleen Spitzer, 5/2/11), the department sent a BSD letter to the editor (if you don’t know what these letter to the editor restating, for all intents and purposes, “look out, there’s a new sheriff in town.” (PS/ If you are not familiar with the acronym “BSD,” please ask a friend to explain.)

But the Journal was right and the U.S. Department of Health and Human Services was wrong.

 

The gist of the Journal editorial can be summed up in these two excepted paragraphs:

 

HHS says its action is about holding corporate CEOs accountable, but it looks more like the Administration's latest bid to intimidate the health-care industry into doing its bidding on prices, regulations and political support for ObamaCare. This is the same agency that has threatened insurers with exclusion from new state-run health exchanges if they raise their premiums more than Mrs. Sebelius wants, or if they spread what she deems to be "misinformation" about the President's health bill.

The hammer on Forest Labs "reinforces everybody's worst fears—that this Administration won't do business with anybody that doesn't completely agree with its policy initiatives. Not only will it refuse to even have the argument, it will actively destroy these people," says Peter Pitts, a former Food and Drug Administration official who now runs the Center for Medicine in the Public Interest.

 

But, just like any other blustering bully, when you stand up for what’s right – the bully folds like a house of cards.

 

On Friday, HHS dropped its foolish efforts to force the resignation of Harold Solomon after protests from the company and major business groups.

 

In another letter, this time to Mr. Solomon, the office of the inspector general of the Department of Health and Human Services said, "Based on a review of information in our file, and consideration of the information your attorneys provided to us both in writing and in an in-person meeting, we have decided to close this case."

 

Oops.  Sorry about that.

 

A statement from the HHS inspector general's office Friday said: "We remain committed to investigating and, when appropriate, sanctioning executives" who engage in health-care fraud. "This includes individuals who directly committed fraud as well as executives who were in a position of responsibility at the time of the fraud.”

 

As they should.  And when the fraud is an attempt by the current residents of the Humphrey Building to cow healthcare companies into obsequious servitude – they should, equally and publically and aggressively, be called to task.

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FDA Not Relaxed About Lazy Cakes

08/05/2011 05:32 PM |

When you think of the FDA the last thing that comes to mind is an agency ready to protect kids from overdosing on brownies baked with melatonin in them. 

"Public health advocates and some mayors are sounding the alarm over Lazy Cakes, a brownie adorned with a lackadaisical cartoon character and laced with a powerful sleep aid that has sold millions nationwide.

“Children are attracted to brownies,” said Dr. Caroline Apovian, director of the Nutrition and Weight Management Center at Boston Medical Center. “I don’t think it’s appropriate to put herbal things that are actually drugs in brownies or food items that are attractive to children. I think that’s heinous.”

One Lazy Cake, which is wrapped in plastic with a photo of a smiling cartoon brownie, contains 8 mg of melatonin, a sleep-inducing supplement not regulated by the federal government. Apovian said 10 mg of melatonin would cause an adult to abruptly fall asleep."

Alarm? Heinous? 

To see the breathless coverage and comments from Nannystaters you would think that the FDA was racing to head off some terrorist plot.  The contraband in question is lazycake brownie advertised as having "relaxation baked in".    I mean they are brownies for goodness sakes, not ground turkey or Avastin...

Of course, all it took was one stupid grown up to spoil snack time for America's youth:

"Earlier this year, a 2-year-old Tennessee boy was hospitalized after a relative gave him a portion of a Lazy Cake, according to news reports."

The brownies have about 10 mg of melatonin in them.  Melatonin pills have about 3 mg of the stuff.  Apart from the toddler from Tenn this is no evidence that the the brownies harming kids or turning them into zombies.  And it's not as if the Lazycake guys are the first to make something quasi-therapeutic taste good too:  Flinstone vitamins anyone? Or how about fruit flavored zinc lozenges?   Maybe we should ban making any medicine flavorful because that would make them "attractive".

I am trying to figure out what alarm is...  Maybe some people believe that if you market brownies laced with melatonin and stress how relaxed they make you feel and well, the next thing you know they'll be selling Chips Ahoy cookies with Valerian root will become the next gateway snack. 

Apparently the FDA will demand changes in the labeling and marketing of the product or else..  Maybe they should require Lazycake to be stored behind retail counters like cough medicines and the morning after pill.   Oh wait, that's a serious proposal under consideration.    So too, I bet, is a lawsuit sometime soon. 

Maybe everyone should just.... chill.  But not with a brownie. Unless there's some perspective and common sense baked into them.



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Part D Success

08/05/2011 04:23 PM |

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A Political Headline if Ever We Saw One

08/04/2011 08:07 AM |

An instant classic inside-the-Beltway headline:

"FDA Approves First-Ever Treatment For Scorpion Stings."
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OCD at OGD and the BioSImilar Two-Step

08/04/2011 07:18 AM |

The FDA is reorganizing it’s Office of Generics Drugs (OGD) to “improve coordination, communication, efficiency and to enhance the Office’s ability to assure that all generic drugs are safe, effective, high quality and interchangeable to the brand name drug product/reference listed drug.”

“Interchangable?”  Hm.

OGD adds another Division to both the Bioequivalence and Chemistry programs, and converts the Microbiology and Clinical Review Staffs into Divisions.  It also formalizes the position of Deputy Director for Science and Chemistry.  Here is the new structure.

OFFICE OF GENERIC DRUGS 
Division of Bioequivalence I 
Division of Bioequivalence II 
Division of Labeling and Program Support 
Division of Microbiology 
Division of Clinical Review 
Division of Chemistry I 
Division of Chemistry II 
Division of Chemistry III 
Division of Chemistry IV

On a biosimilar note, BioCentury reports that the FDA reiterated plans for a two-step regulatory process for biosimilars that includes evaluating similarity and then interchangeability, according to an article published in the New England Journal of Medicine on Wednesday.

 

The agency will first review the similarity of a biologic to an FDA-approved reference product using a "totality-of-the-evidence" approach, which includes a review of comparative analytic data and in vitro data. Based on the initial review, FDA will determine if additional animal or human studies are required for approval as a biosimilar.

 

To meet the higher hurdle of interchangeability with a reference product, a manufacturer must demonstrate that the biosimilar is expected to produce the same clinical result in patients, and that switching between the two products does not increase a patient's risk compared with continued use of the reference product.

 

Earlier this year, senior FDA officials began outlining plans for the two-step process. The agency expects to issue a series of guidance documents on the process

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And that's not even counting what's behind the couch cushions in Peggy's office

08/03/2011 10:51 AM |

According to the Pink Sheet, FDA has amassed a large reserve fund throughout PDUFA IV, but will likely be forced to spend most of it in the next fiscal year as application volume declines and more personnel move to the agency's new headquarters.

 

FDA ended FY 2010 with more than $150.6 million in the carryover account, a 252% increase from the $42.8 million in the account as of June 30, 2006. The agency said aside from excess fee collections during PDUFA III, the fund also included fees saved for the agency relocation to its White Oak campus that were allocated during PDUFA IV and a reserve for refunds.

 

Spending the carryover funds will allow FDA to reduce the size of the user fee the upcoming fiscal year, although that will probably feel like a small comfort to sponsors facing a more than 19% increase in FY 2012, which brings the total fee for a full application requiring clinical data to $1.842 million.

 

Two of the largest carrover balance expenses will be personnel-related. The agency said in the notice it expects to spend about $37.9 million to move the Center for Biologics Evaluation and Research to its White Oak campus in Silver Spring, Md. by FY 2014. CBER now is located in nearby Rockville, Md.

 

The General Services Administration already approved the project and President Obama allocated $23.68 million in his FY 2012 budget request to complete the lab and ensure it is ready for use by FY 2014. FDA said without the investment, it would be forced to pay rent for a new lab it cannot use and for an old lab it cannot vacate.

 

FDA also plans to spend $29.8 million from the carryover balance in FY 2011 and FY 2012 to pay for 53 new full-time equivalent employees. The hires were authorized in FY 2009 to handle additional work created by the FDA Amendments Act's drug safety provisions.

 

Another $2.5 million of the carryover fund must be reserved for refunds, the agency said in the notice.

 

FDA also is obligated by PDUFA rules to use some carryover money to offset industry fee overpayments made from FY 2002 and FY 2007. That nearly $31 million payment lowered the revenue target and, subsequently, the fees sponsors will pay. The agency said in the notice fee payments from FY 2008 through FY 2011 will be more than $27.2 million less than the amounts appropriated, which would not require an offset payment.

 

The agency also will be forced to cover two years of shortfalls with the carryover balance that were caused by slumping submissions. The agency projected an $8.4 million revenue shortfall in FY 2011 and an $8.7 million shortfall in FY 2012, according to the notice.

 

After receiving 17 fewer full paid applications in 2010, the agency adjusted its assumptions for annual volume to be 5.5 submissions fewer in FY 2011 and FY 2012, which caused the shortfalls. FDA received 118.4 fee paying full application equivalents in FY 2010 and estimated it would receive 102.5 through the end of FY 2011. Both were near record lows since PDUFA was implemented in FY 1993.

 

The shortfalls also likely influenced an FDA decision to lower its revenue target for operational reserves in early FY 2013. The agency is allowed to add three months of operating expenses to its fee calculations for the final year of a PDUFA cycle so it can "assure sufficient operating reserves" at the start of the next fiscal year, which would be the first for PDUFA V.

 

Three months of revenue at that time would be $169.2 million. When the remaining $32.4 million in the carryover balance is subtracted out, the agency would need another $136.9 million.

 

But FDA decided it would "assume more risk" and only require two months of operating expenses for the reserve, lowering the required amount to $80.4 million. The agency said including the full three months in FY 2012 "poses a substantial burden on the regulated industry at a time when it is undergoing significant financial strain," according to the notice.

 

The decision will save sponsors of applications requiring clinical data about 8% in fee payments. The fee would have been about $1.99 million if FDA demanded a three-month reserve.

 

When the House approved the FY 2012 Agriculture/FDA appropriations bill in June, it gave the agency a miniscule $3 million budget increase. User fee revenue increases were used to offset a $285 million cut in federal funding.

 

For more discussion of PDUFA, have a look (and bookmark) www.modernmedicines.com. It’s an important and useful site from the folks at Eli Lilly & Co on all-things PDUFA.

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Got tonsillitis? Keep calm and carry on.

08/02/2011 06:58 AM |

Remember “SiCKO?” That was the Michael Moore “documentary” that showed how, if the US would adopt the NHS model, our own healthcare problems would vanish.

Well, as this article from the British newspaper, “The Independent,” shows – well, reality bites.

(Can you imagine President Obama or any member of Congress telling parents that their kids can't have their tonsils out until they have had seven -- that's right seven -- bouts of tonsillitis?)

Cataracts, hips, knees and tonsils: NHS begins rationing operations

Almost two-thirds of trusts affected as cuts bite

Hip replacements, cataract surgery and tonsil removal are among operations now being rationed in a bid to save the NHS money.

Two-thirds of health trusts in England are rationing treatments for "non-urgent" conditions as part of the drive to reduce costs in the NHS by £20bn over the next four years. One in three primary-care trusts (PCTs) has expanded the list of procedures it will restrict funding to in the past 12 months.

Examples of the rationing now being used include:

* Hip and knee replacements only being allowed where patients are in severe pain. Overweight patients will be made to lose weight before being considered for an operation.

* Cataract operations being withheld from patients until their sight problems "substantially" affect their ability to work.

* Patients with varicose veins only being operated on if they are suffering "chronic continuous pain", ulceration or bleeding.

* Tonsillectomy (removing tonsils) only to be carried out in children if they have had seven bouts of tonsillitis in the previous year.

* Grommets to improve hearing in children only being inserted in "exceptional circumstances" and after monitoring for six months.

* Funding has also been cut in some areas for IVF treatment on the NHS.

The alarming figures emerged from a survey of 111 PCTs by the health-service magazine GP, using the Freedom of Information Act.

Doctors are known to be concerned about how the new rationing is working – and how it will affect their relationships with patients.

Birmingham is looking at reducing operations in gastroenterology, gynaecology, dermatology and orthopaedics. Parts of east London were among the first to introduce rationing, where some patients are being referred for homeopathic treatments instead of conventional treatment.

Medway had deferred treatment for non-urgent procedures this year while Dorset is "looking at reducing the levels of limited effectiveness procedures".

Chris Naylor, a senior researcher at the health think tank the King's Fund, said the rationing decisions being made by PCTs were a consequence of the savings the NHS was being asked to find.

"Blunt approaches like seeking an overall reduction in local referral rates may backfire, by reducing necessary referrals – which is not good for patients and may fail to save money in the long run," he said. "There are always rationing decisions that have to go on in any health service. But at the moment healthcare organisations are under more pressure than they have been for a long time and this is a sign of what is happening across many areas of the NHS."

According to responses from the 111 trusts to freedom-of-information requests, 64 per cent of them have now introduced rationing policies for non-urgent treatments and those of limited clinical value. Of those PCTs that have not introduced restrictions, a third are working with GPs to reduce referrals or have put in place peer-review systems to assess referrals.

In the last year, 35 per cent of PCTs have added procedures to lists of treatments they no longer fund because they deem them to be non-urgent or of limited clinical value.

Some trusts expect to save over £1m by restricting referrals from GPs.

Chaand Nagpaul, a member of the British Medical Association's GPs committee, said he was concerned about PCTs applying different low-priority thresholds and rationing access to treatments on the basis of local policies.

He said the Government needed to decide on a consistent set of national standards of "low priority" treatments to help remove post-code lotteries in provision. "Patients and the public recognise that with limited resources we need to make the maximum health gains and so there needs to be prioritisation. What is inequitable is that different PCTs are applying different thresholds and criteria," he said.

A Department of Health spokesman said: "Decisions on the appropriate treatments should be made by clinicians in the local NHS in line with the best available clinical evidence and Nice [National Institute for Health and Clinical Excellence] guidance. There should be no blanket bans because what is suitable for one patient may not be suitable for another."

Bill Walters, 75, from Berkshire, recently had to wait 30 weeks for a hip operation instead of the standard 18. "I believe that the Government is doing this totally the wrong way," he said.

Case study: 'They changed the rules to save money'

Anne Ball, 71, is a retired business consultant who used to work in electronics

"I have bilateral cataracts and under the original NHS criteria I was entitled to have at least one of mine treated – but then the West Sussex health authorities decided to change the threshold level to save money.

"It's like looking through gauze. Everything is foggy, and I've got quite a large 'floater' in my left eye. The consultant was as distressed as me, having to tell me, and he thought with my eyesight he wouldn't be able to function.

"I've appealed because the cataracts are having a significant impact on my quality of life and it's left me depressed and fearful about my low vision, which will continue to deteriorate. The new guidelines mean that people who fall below the standard set by the DVLA still do not qualify to have surgery. My vision is not good enough to drive at night.

"I'm not a cranky old lady. I'm the chair of a local village charity and I do a lot of computer work that is affected.

"It will just store up costs for future years, putting a strain on resources as more patients will end up in falls clinics. The longer you put it off the more complex the operation becomes and the riskier it is for the patient."

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Obamacare in the Crosshairs in 2012

08/01/2011 05:09 PM |

This article in the Washington Examiner makes an excellent point:  Obamacare will be a centrai element of the 2012 campaign.
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Turning Point or Tipping Point?

08/01/2011 08:11 AM |

According to FDA Commissioner Peggy Hamburg there  is “a lot of energy” spent by industry and FDA on DTC issues … I think it’s a missed opportunity to do something much better if we’re going to be talking about drugs and health to the public at large. Certainly one of the discussions that I’ve been engaged in with industry is how can we use some of the time and money that they’re putting into this to really address broader public health concerns and broader education with the public about important health issues.”

I agree!  Have a look at this article from Health Affairs for more on this issue.

The article’s conclusion –

“Working together with industry, we can make a difference. We can make DTCA a more potent, precise, and persuasive tool on behalf of the public health. And rather than rubbing the lamp and wishing, we need to burn the midnight oil and work harder to make it a reality—because an educated consumer is our best customer.”

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Is Big Pharma a Social Media Nin-compoop?

08/01/2011 07:50 AM |

There came a time w hen the risk to remain tight in the bud was more painful than the risk it took to blossom.  ~Anaïs Nin

Just back from the ePharma West conference where I was pleased to give a keynote address on the future of social media.

Some snippets:

Social media is communications at the speed of life. As Marshall McLuhan wrote, “"At electric speed, all forms are pushed to the limits of their potential." 

(Replace “electric” with “digital” and it’s amazing how prescient McLuhan was.  That’s genius.) That’s a wonderful challenge, to be pushed to the limits of our potential. But wait, it gets more complicated.

Healthcare social media has precious few rules.  But there’s only one Golden Rule -- transparency. 100% transparency. 100% of the time.  You can’t airbrush social media.

Social media for regulated industry is a wonderful green field of opportunity. But to maximize the opportunity, we must accommodate the reality of a messier world.  Social media, almost by definition, is messy – and the regulatory framework (or lack thereof) is equally so. And it’s not likely to get much better. Get used to it.

Embracing social media means embracing regulatory ambiguity. And that’s a paradigm shift for an industry that has (in a post-Vioxx world) been going in precisely the opposite direction.

Social media (and its game-changing  opportunities) demands a move away from the cautious tactics of the Vioxx Populi towards a better understanding of the digital Vox Populi. And that means more than sponsored Google links and branded Facebook pages with the interactivity turned off.

It means mixing it up with real people in real time. And when it comes to FaceBook, it means – turn the interactivity on! 

It’s not going to be easy, or risk-free, or inexpensive.  And whatever social media “marketing models” companies build will have to be elastic – just like the media environment in which they are designed to operate.

Benjamin Franklin once said: “Every problem is an opportunity in disguise.” While Facebook strategies and approaches have to be reexamined, Mr. Zukerberg’s medical mandate provides pharmaceutical marketers with an excellent opportunity to finally acknowledge and embrace the full capabilities of two-way social communication writ large.

FaceBook’s changes represent an opportunity for regulated industry to learn, understand and embrace the three key tenets of Pharmaceutical Marketing 3.0:

1. The Rise of the “Face of Pharma”

For the past 20 years, the overwhelming majority of pharmaceutical marketing budgets were dedicated to promoting specific products.

Now, due to both a less robust drug development pipeline and an increase in the rates of patent expiry, the next era of pharma marketing will put the company – and it’s corporate reputation – front and center.

When you think about it (if you allow yourself to think about it), its a perfect match for social media where transparency is the most urgent, non-negotiable and magnificent mantra.

Not third party groups, not KOLs (although these traditional avatars have their place) – but the company speaking on behalf of itself and its products.  What a concept!

2. The Role of Social Media in the Era of Post-Patent Medicine

I believe that the blockbuster era of the pharmaceutical industry will be replaced by the Era of Post-Patent Medicine. To compete in an era of generics and biosimilars, Pharma companies will need not only a robust portfolio of lower cost medications, but an army of brand loyalists.

Communications programs, supported by social media must be one tool. Why? Because it’s where the people are.

3. Social Media Can Help Increase Patient Education and Prescription Compliance

You know the numbers. It’s estimated that Pharma loses $30 billion a year in patient non-compliance. True two-way social media has the potential to serve as a new and puissant health education platform by helping to keep patients informed of the dangers of non-compliance by earning their trust through transparent dialogue. And that’s twice as true when it’s mobile-based.

As another conference presenter, Dr. James Fowler, of the University of California at San Diego opined, “Pharma must realize their own network power.”

Amen.

PS/ I am also pleased to announce that I have joined the board of the Digital Health Coalition - a nonprofit corporation - seeks to promote responsible innovation via digital marketing and communications in a connected world. Their first initiative is focused on the rapidly evolving space of social media and seeks to promote a world where patients, physicians, and brands can connect, empower, and drive positive health outcomes. Individuals interested in learning more about the Digital Health Coalition are encouraged to visit:

http://www.digitalhealthcoalition.orgwww.digitalhealthcoalition.org

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To Burr, with Love

07/29/2011 07:46 AM |

To Burr, with Love

BioCentury reports that Senator Richard Burr (R-N.C.) threatened Thursday to delay reauthorization of medical device and prescription drug user fee legislation unless FDA implements steps to improve and speed product reviews. Speaking at a Senate committee on Health, Education, Labor and Pensions hearing, Burr said user fees, especially for medical devices, have not improved FDA performance and expressed skepticism that increasing user fees would improve the situation. He said reauthorization will become "a very slow and laborious process" unless the new legislation has measurement tools to track whether a fee system produces better outcomes

HELP committee Chairman Sen. Tom Harkin (D-Iowa) pushed back, saying that safety and efficacy are more important than speed to market. He also said FDA is understaffed and underfunded, so more money could improve its review performance.

They’re both right.

PhRMA wants dedicated biosimilars funding

The merits of creating a dedicated appropriation for biosimilars reviews has emerged as a point of contention in closed door FDA-hosted biosimilars user fee stakeholder discussions. In a July 24 letter from the Pharmaceutical Research and Manufacturers of America (PhRMA) to FDA, the trade association came down solidly on the side of creating a funding stream for biosimilar reviews that is separate from PDUFA-funded drug reviews.

 

PhRMA also called for a separate biosimilars user fee "trigger," or minimum amount Congress must allocate for biosimilars reviews to enable FDA to spend user fees. A trigger was built into PDUFA with the goal of making user fees supplement, not replace, federal funding. The law creating a biosimilars pathway called for FDA to fund biosimilars reviews from PDUFA funds until October 2012, when biosimilars user fees are expected to kick in. Applying PDUFA to biosimilars past October 2012 would drain resources from reviews of innovative medicines, according to the PhRMA letter.

Lack of money is the root of all evil.
-- George Bernard Shaw

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Part D Hearty

07/29/2011 07:30 AM |

This week the mainstream media discovered patent expirations and the headlines rang, “drug prices plummet!”

 

But they missed the real story.

 

From JAMA:

Implementation of Medicare Part D and Nondrug Medical Spending for Elderly Adults With Limited Prior Drug Coverage

 

1.      J. Michael McWilliams, MD, PhD;

2.      Alan M. Zaslavsky, PhD;

3.      Haiden A. Huskamp, PhD

 

Author Affiliations

 

1.  Author Affiliations: Department of Health Care Policy, Harvard Medical School (Drs McWilliams, Zaslavsky, and Huskamp); and Division of General Internal Medicine and Primary Care, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (Dr McWilliams), Boston, Massachusetts.

Abstract

Context Implementation of Medicare Part D was followed by increased use of prescription medications, reduced out-of-pocket costs, and improved medication adherence. Its effects on nondrug medical spending remain unclear.

Objective To assess differential changes in nondrug medical spending following the implementation of Part D for traditional Medicare beneficiaries with limited prior drug coverage.

Design, Setting, and Participants Nationally representative longitudinal survey data and linked Medicare claims from 2004-2007 were used to compare nondrug medical spending before and after the implementation of Part D by self-reported generosity of prescription drug coverage before 2006. Participants included 6001 elderly Medicare beneficiaries from the Health and Retirement Study, including 2538 with generous and 3463 with limited drug coverage before 2006. Comparisons were adjusted for sociodemographic and health characteristics and checked for residual confounding by conducting similar comparisons for a control cohort from 2002-2005.

Main Outcome Measure Nondrug medical spending assessed from claims, in total and by type of service (inpatient and skilled nursing facility vs physician services).

Results Total nondrug medical spending was differentially reduced after January 1, 2006, for beneficiaries with limited prior drug coverage (−$306/quarter [95% confidence interval {CI}, −$586 to −$51]; P = .02), relative to beneficiaries with generous prior drug coverage. This differential reduction was explained mostly by differential changes in spending on inpatient and skilled nursing facility care (−$204/quarter [95% CI, −$447 to $2]; P = .05). Differential reductions in spending on physician services (−$67/quarter [95% CI, −$134 to −$5]; P = .03) were not associated with differential changes in outpatient visits (−0.06 visits/quarter [95% CI, −0.21 to 0.08]; P = .37), suggesting reduced spending on inpatient physician services for beneficiaries with limited prior drug coverage. In contrast, nondrug medical spending in the control cohort did not differentially change after January 1, 2004, for beneficiaries with limited prior drug coverage in 2002 ($14/quarter [95% CI, −$338 to $324]; P = .93), relative to beneficiaries with generous prior coverage.

Conclusion Implementation of Part D was associated with significant differential reductions in nondrug medical spending for Medicare beneficiaries with limited prior drug coverage.

 

http://jama.ama-assn.org/content/306/4/402.full.pdf+html

 

http://jama.ama-assn.org/content/306/4/402.short

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Progressive Improvements

07/28/2011 03:37 PM |

Recently BIO released a white paper on post-PDUFA FDA reform.  (Full details can be found here.)

Many good ideas – but one that gets the blood flowing (whether you’re for or against):  “progressive approvals.”

Sounds good (at least in theory) to many. But there are some tough questions. As an FDA insider opined, What exactly would the standard for progressive approval be? And would every one of the progressive approvals come with some sort of access control?”

 

Attempting to address some of these unknowns (via an op-ed in the Wall Street Journal) are Michael Boldrin (chair of the economics department at Washington University in St. Louis) and S. Joshua Swamidass (medical professor at Washington University).

 

They write:

 

“We can reduce the cost of the drug companies' bet by returning the FDA to its earlier mission of ensuring safety and leaving proof of efficacy for post-approval studies and surveillance.”

 

I’m not sure where they get the “earlier mission” statement, but let’s allow them to continue.

 

“In exchange for this simplification, companies would sell medications at a regulated price equal to total economic cost until proven effective, after which the FDA would allow the medications to be sold at market prices.”

 

Leaving the difficulty of determining what such a “regulated price” might be (and don’t for a minute believe that the devil isn’t in the details), an even tougher question (and a real rabbit hole of one) is the issue of “until proven effective.”

 

What does “effective” mean? Does it mean “cure” or “remission?” Does it mean "cost effective?" Or extension of life? And, if so, for how long?  5 years?  5 months? 5 minutes?  And who makes the call? 

 

According to Boldrin and Swamidass, “Doing so will improve all of our lives, decrease the cost of health care, and unleash the next wave of medical innovation.

 

It’s a weak argument in support of an important discussion.

 

Do we really want to open the door for tacit price controls and healthcare technology assessment in return for a very questionable upside?

Safety without efficacy?  Really?

Better to pursue a path last publicly discussed in April 2009 when Merck agreed to peg what the insurer Cigna pays for the diabetes drugs Januvia and Janumet to how well Type 2 diabetes patients are able to control their blood sugar.

 

Now that’s progressive.

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Media Drops BPA Ball

07/27/2011 04:01 PM |

Scary stories about Bisphenol-A (BPA) over the past  year?  About 100

Stories reporting on the study that demonstrated that even when human cram themselves with BPA-heavy diets scientists "find the substance (in urine and blood)  below our ability to detect them, and orders of magnitude lower than those causing effects in rodents exposed to BPA"?  17

As Trevor Buttorworth points out in his blog on Forbes: " the media have ignored the stunning finding – double checked before publication – that overturns pretty much everything the press has told the public about this common chemical."  tinyurl.com/3wcgbl6

The Enviromental Protection Agency's response to the study?

EPA considers new call for toxicity testing of BPA

"The Environmental Protection Agency solicited public comment, July 26, about whether to require new toxicity testing and environmental sampling of bisphenol A, an ingredient in many plastics and food-contact resins." 

All of which will be duly reported by the media in he-said, she-said fashion. 
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Is FDA A Deadend for Medical Devices and Diabetic Kids??

07/27/2011 10:15 AM |

Another depressing example of how the path for approval of  medical devices has become constipated at the FDA in response to the so-called consumer advocates such as Public Citizen, Consumers Union, Merrill Goozner, Diana Zuckerman.    To quote British philosopher Isaiah Berlin, "disregard for the preferences and interests of individuals alive today in order to pursue some distant social goal that their rulers claimed is their duty to promote has been a common cause of misery of people throughout the ages."   The groups above have been a constant source of misery in our time.


www.sfgate.com/cgi-bin/article.cgi

Lives wasted as FDA stalls on diabetes care

Pam Sagan

Wednesday, July 27, 2011

For more than 20 years, my daughter Piper has lived with the constant, frightening, deceptive and malicious disease called type 1 diabetes. Piper has always been prone to the kind of hypoglycemic - low blood sugar - life-threatening attacks that come on hard, fast and without warning. She almost drowned as a youngster after becoming unconscious from low blood sugar. In college, she went into hypoglycemia while she slept and didn't wake up in the morning. Fortunately, she was discovered and emergency care saved her life.

Unfortunately, the Food and Drug Administration has been dragging its feet on technologies that could revolutionize diabetes care and make these kinds of episodes a thing of the past. Key trials are on hold and it looks to be years more before these proven, life-saving technologies are available for patients in the United States. Meanwhile, kids are dying.

Every hour of every day, individuals with type 1 diabetes have to balance insulin, food and activity to try to prevent low and high blood sugars, and the devastating and costly complications: seizures, comas, kidney failure, heart disease, blindness and amputations. The human cost is incalculable; the economic cost isn't: Diabetes costs our nation more than $174 billion a year and $1 in $3 of Medicare spending goes to care for people with diabetes.

Perhaps the most gut-wrenching story of diabetes is the specter of "dead in bed" - kids found dead in the morning after a completely normal evening. Dead in bed occurs because blood sugar levels can suddenly change. When this happens while sleeping you are unable to adjust insulin to right the body's blood sugar, which can be life threatening.

We know how to prevent these attacks, but we don't - at least not here in the United States. Breakthrough technologies that protect against dangerous diabetes episodes are already available elsewhere, but not at home. Low-glucose suspend systems have been approved for nearly three years and used safely in more than 40 countries worldwide, but they are not available in the United States because of the FDA's unnecessarily slow process.

These pumps stop delivering insulin automatically when a monitor indicates that the body's glucose levels are low. The low-glucose suspend technology is the first phase of an artificial pancreas, a combination of a continuous glucose monitor and an insulin pump with software that would communicate between the two to automatically monitor glucose levels and administer insulin doses. The artificial pancreas would address both high and low blood sugar levels. In 2006, the FDA recognized the importance of this technology and placed the artificial pancreas on its Critical Path Initiative. But now key trials are on hold until the FDA provides a roadmap for outpatient studies. A draft is promised in December.

It should not have taken this long, and must not take any longer. When I testified before Congress, my message was simple: this technology could revolutionize diabetes care and it is imperative that the FDA provide reasonable guidance immediately. Waiting is not an option. My daughter's life, and those of millions of people with diabetes, depends on it.

Pam Sagan of Los Altos is a former board member of the Juvenile Diabetes Research Foundation International.

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Waive this!

07/26/2011 01:01 AM |

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FDA Mission Creep: There's an App for that

07/25/2011 08:37 AM |

Mission creep is a worrisome thing – especially at the FDA.

Awhile back there were some folks at CDRH who believed that the mobiles that you hang over a baby’s crib should be classified as a medical device because they can impact vision development.

No – really.

Fortunately, cooler minds prevailed and sanity won the day.

Today, the issue is whether or not some mobile apps can be considered medical devices.  It’s important for many reasons, not the least of which is that over-regulation or the threat of FDA action will slow both the development and adoption of mobile technologies for a variety or urgent public health purposes.  Adherence and compliance come to mind as well as safety issues relative to appropriate use/safe use.

To that end, an interesting audio interview in the Burrill Report. It's with Joe Smith, chief medical and science officer for the Gary & Mary West Wireless Health Institute about new draft guidance from the FDA on medical apps, how the agency is approaching these products, and whether this provides the clarity needed to promote investment and innovation in this new world of digital health.

The interview can be found here.

This issue, BTW, is yet another reason why the name of CDRH (the Center for Devices and Radiological Health) needs to change to the Center for Medical Technology.

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