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Please sir, I want some more … of my medicine.

According to the Daily Telegraph:

Cash-strapped health authorities are doubling the effective cost of medicines for some patients with long-term conditions. They are urging GPs to reduce the number of pills on a given prescription, which now cost £7.40 a time in England. In some cases the number of pills per prescription has halved.

While health authorities say the guidance is to help reduce the NHS bill for wasted medicines - estimated at up to £300 million a year - there is suspicion that health authorities are increasingly resorting to the measure for financial reasons.

Health care trusts have been asked to changed their guidance to GPs in order to get them to issue shorter prescriptions for some patients.

Our friend and colleague David Taylor, professor of pharmaceutical policy at the University of London, warned that shorter prescriptions for those who were "well established" on medications could actually increase costs because of higher dispensing fees.

He said: "You need a flexible approach and not a rigid rule."

David Stout, chief executive of the PCT Network (one of the largest health care trusts), emphasized the prescription rationing idea was to save money through cutting waste, rather than increasing prescription charge revenue.

Further, study after study demonstrates that the more frequently a patient has to refill a prescription, the more likely that patient is not to refill that prescription.

Non-compliance is a bad strategy for cost-containment.

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Biocentury reports ...

Genentech, CDER submit joint statement on Avastin

Genentech Inc. and FDA's Center for Drug Evaluation and Research said in a joint statement they have been unable to agree on "the central questions that must be answered" for Commissioner Margaret Hamburg to render a decision about whether to withdraw metastatic breast cancer from the label of Avastin bevacizumab.

Instead of submitting a single joint list of facts in dispute, the parties submitted a partial list that includes whether actions by other regulatory authorities and data from studies outside the first-line setting are relevant. Each party now intends to submit a separate document summarizing what it considers to be the central questions to be presented and resolved. Genentech and CDER have until May 5 to submit their summaries.

Karen Midthun, who is the presiding officer for a hearing on the matter scheduled for June 28-29, had asked the Roche (SIX:ROG; OTCQX:RHHBY) unit and CDER to submit a joint statement outlining facts that are not in dispute and issues that are disputed.

Talking the Talk

  • 04.07.2011
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The Association of the British Pharmaceutical Industry has selected a comms man, Stephen Whitehead, to be its next chief executive. Whitehead has spent the past few years working in corporate affairs at a U.K. financial services group. He was group communications director at Prudential PLC, between 2007 and 2010; before that he was group corporate affairs director at the U.K. bank, Barclays PLC. But Whitehead also has pharmaceutical industry experience - he spent 10 years at Glaxo PLC and Eli Lilly & Co. in corporate affairs, becoming European director of corporate affairs at Lilly before leaving the sector in 2003.

 

As the Pink Sheet reports, “The association's choice of a leader with public communications and lobbying experience is timely. Whitehead comes on board at a time of policy transition - perhaps more accurately, turmoil - for U.K. pharmaceutical companies. They are facing the replacement of a 50-year-old method of controlling their pricing and profits, the Pharmaceutical Pricing Regulation Scheme (PPRS), with a so far vaguely defined value-based pricing scheme.”

 

We are also pleased to report that our friend and colleague Richard Bergstrom has begun his new job as director general of the European Federation of the Pharmaceutical Industries and Associations EFPIA. (Richard was formerly director general of LIF, the trade association for the Swedish pharmaceutical industry.)

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Is there are rhyme or reason to the FDA’s approach to safety?

On food dyes and ADHD there was no reason to revisit an issue that channels the same approach to causality the Andrew Wakefield, Jenny McCarthy and anti-vax crazies used.   (And shame on the media for not referring to the European Food Safety Agency report trashing the Lancet article most reporters cited – in tandem with a real life story of a kid being cured of ADHD by going natural.  As in:  “In 2009, EFSA re-evaluated the safety of the six color additives used in the Southampton study and concluded that the available scientific evidence does not substantiate a link between the color additives and behavioral effects.)


Are reporters that biased or lazy that they can’t get beyond the he-said/she-said approach to reporting. 

In any event,  why, with this knowledge in hand did the FDA grant Center for Science in the Public Interest’s ( the same group that sued McDonald’s for offering Happy Meals to kids) citizen petition which was submitted in 2008?

Now the FDA has decided to allow pharmacists to compound a drug (Makema) developed by KV Pharmaceutical  that significantly reduced the risk of certain preterm births in women who have had at least 1 prior preterm birth. Previously, the agent had only been available from pharmacies that had compounded the drug.”  The FDA and ob-gyns had wanted a version of the injectable  product that meet specific safety and efficacy standards.  Since “Makena is a sterile injectable with a risk of contamination, greater assurance of safety is provided by an approved product. “

http://www.modernmedicine.com/modernmedicine/Clinical+News/FDA-wont-take-action-against-pharmacies-that-compo/ArticleStandard/Article/detail/714333?contextCategoryId=40157

After developing an FDA approved version of a drug that was in danger of becoming obsolete, KV promptly – and without warning – decided to charge $1500 for each dose.   The company was rightly criticized for the sudden jump in price and did the right thing by cutting the retail price of the drug to $680 and offering the drug for free for a Medicaid price to a wide range of organizations.

The FDA decided to allow pharmacists to continue compounding even though KV developed the drug to put an end to the risk associated with compounding products.  In case anyone didn’t know, the FDA is currently
Investigating “bacteria that sickened 19 people at Alabama hospitals and may have killed nine and has turned up at compounding  pharmacy in Alabama.


And then there were the pre-filled syringes of heparin and contaminiated compounded CF drugs.There are many more such examples.

To be sure the FDA does have the authority to ensure the availability of products and indirectly considers affordability.  It did so when it kept generic asthma inhalers on the market for several years rather than forcing them off to comply with an EPA requirement to remove inhalers powered by CFCs.

But that was a well-considered and organized action.  This is a reaction to the media hype.  Indeed,  the FDA even got involved in a little demagoguery when it cited the fact that the NIH had provided KV with support to conduct clinical trials as the reason to allow the compounding they sought to eliminate.   Give that logic, maybe every drug developed in cooperation with the NIH or based on NIH research should be compounded.   How about a nice home made batch of Herceptin or HIV drugs such as Prestiva and Norvir?

All of this is preceded by the FDA’s children’s cough medicine obsession, you know that deadly drug that is linked to 39 deaths over 20 years, most of them do to overdosing by parents?

The FDA is in a shambles because of it’s pursuit of a politically correct position instead of a science-based regulatory policy.  It's already discourage the makers of cancer drugs from pursuing follow studies by shifting the Avastin endpoint to overall survival.  Now, its piling on KV and permiting the type of compounding that KV's drug was supposed to eliminate in an effort to protect expectant mothers. This is the Precautionary Principle run amok.


“In the multitude of counsellors there is safety.”

 

--  Proverbs xi.14.

 

CDER’s  Office of Surveillance and Epidemiology has been raised to the level of a a “super-office” to provide (at least in theory) greater management support to the unit’s growing staff and responsibilities.

 

As outlined by Super CDER Director Janet Woodcock, OSE will become a super-office that houses two new subordinate offices. According to Janet, “As OSE continues to build capacity and take on new responsibilities, and as the breadth, depth and volume of its work continue to increase, we need an organizational structure that provides adequate management support for these vital program areas.”

 

The changes will result in a new layer of management, in the form of the two new offices under OSE, which will have their own directors and deputy directors. The creation of a second epidemiology division, with its own director and deputy director, also will provide additional management support.

 

The Pink Sheet opines that, “The reorganization opens the door to a leadership change atop OSE.” Although OSE’s current director, Gerald Dal Pan, will serve as acting director of the new super-office, FDA will conduct a nationwide search for a permanent director.

 

“There is no safety in numbers – or in anything else.”

 

-- James Thurber
 

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When it comes to the patient voice at the June 28-29 ODAC meeting on Avastin, silence most certainly does not imply consent

 

FDA's Karen Midthun, who will serve as presiding officer for the second ODAC hearing on the future of bevacizumab's (Avastin) breast cancer indication, has rejected Genentech’s request to allow members of the public to speak at the meeting.

 

This seems to be in direct contradiction to statements from CDER Office of New Drugs Director John Jenkins, who has gone on the public record that a crucial piece of risk/benefit assessment is the patient perspective.

 

"I think it's very important to understand the patients' perspective about how they value the benefits and how they are willing to accept the risk … A lot of us are basing these decisions in the abstract. We don't have the disease, we haven't achieved the benefit, and we do not actually have to weigh, personally, that benefit against the risk."

 

And further, "Regulators and others may not consider those benefits to be very important, but to the patients, they are extremely important and allowed them to go on about their lives.”

 

Dr. Midthun’s decision to ban patient comment is also contrary to the spirit of the 11/22/10 PDUFA negotiating session, where the FDA said that information about patients’ understanding of existing treatment tools is considered valuable, but is not consistently available during the review process.

 

The upcoming “Avastin Meeting” is, in all particulars, the  perfect opportunity to take the “patient involvement” hypothesis out for a spin. Why is the agency afraid of what patient groups might say? Or does ODAC simply consider the patient voice not relevant?  Advice mustn’t only be sought and considered when it supports your position.

 

After all, in the words of Dr. Jenkins, “We have to be aware of the societal expectations of how we interpret our standard and how we make our decisions.”

Bad Medicine

  • 04.04.2011
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Bad Medicine


Vox News

  • 04.04.2011
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To paraphrase the late Dr. Martin Luther King, Jr., “There comes a time when people get tired … and we have no alternative but to protest.”

There has been a lot of moaning and groaning about the FDA’s continued delay in releasing social media guidance.  As if it matters.  Various DDMAC panjandrums have consistently said that what regulated industry marketers want most, predictable “how to” guidelines relative to specific platforms (FaceBook, YouTube, Twitter, etc.) is not on the docket nor is direction on adverse event discovery, reporting, or responsibility.  Expecting a regulatory Holy Grail will only lead to disappointment and frustration.  And blaming the FDA when that happens won’t make anything better or move the social media agenda ahead any further or faster.

Social media for regulated industry is a greenfield 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.

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.

Nobody said it was going to be easy. And marketers have to get used to it if regulated marketing is going to succeed and thrive in the 21st century. 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.  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.

The most constructive “podium policy” from the FDA (in this case from Jean-Ah King, special assistant to DDMAC Director Tom Abrams) has been, ““The bottom line is this is a regulated industry, and if you choose to do promotion in that area (social media) just make sure that at the end of the day what we’re looking at is in the best interest of public health.”

Obvious – but important to remember.  And, in the words of Winston Churchill, “Ease is relative to the experience of the doer.”
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Here is the actual FDA statement on it’s pending social media guidance:

“It is difficult to provide a timeframe for the issuance of our guidances due to the extensive work and review process, or ‘Good Guidance Practices' (GGPs), which ensures that FDA's stakeholders are provided well vetted guidances articulating FDA's current thinking on a topic.”

And here is the much more amusing April Fool’s version from the creative minds over at Medical Marketing & Media Magazine:

DDMAC social media guidelines include "dislike" button for bad ads

 

The FDA surprised the industry by rolling out detailed social media marketing guidance and a beefed up “Bad Ad” program that will use crowdsourcing to inform federal formulary access decisions.
 
Just days after announcing it would miss a second deadline for the hotly anticipated draft guidance, the agency reversed course. At a hastily assembled press conference Friday morning, Division of Drug Marketing, Advertising and Communications director Tom Abrams outlined the new policy.
 
The theme of DDMAC's Good Guidance Practices, said Abrams, is "Back to the future."
 
"We believe that companies can best offer truthful, non-misleading and balanced information on regulated products through proven technology until those products are themselves proven," said DDMAC's Jean-Ah Kang. "Meaning that they've been on the market for, say, 13 years or so."
 
Accordingly, DDMAC will now require that all web pages for branded prescription pharmaceutical products be optimized for the Netscape Navigator browser. Pharmas, the agency said, may provide information about their products on Friendster, though not on Facebook, Twitter, YouTube, Orkut or even MySpace.
 
A "dislike" button, inspired by the agency's "Bad Ad" program, will be required for all content deemed promotional, and the data generated will inform the Independent Payment Advisory Board's recommendations for Medicare coverage. Search ads for regulated products will be required to carry a tag in flashing red script reading "WARNING! This site may harm your computer!"

In keeping with that guidance, the agency unveiled a revamped website with what Abrams hailed as a "cool retro-'90s look." A polka band played a cover of Nirvana's "Smells Like Teen Spirit" as Abrams fiddled with Powerpoint slides of the site.

Abrams fired a warning shot to marketers looking to imitate the behavior of “today's youth” in their digital communications. “Regulated industries should refrain from ‘sexting,' whatever that is,” he declared. “It just sounds nasty. Don't do it."
 
As
predicted by MM&M back in February, Abrams named former Propecia marketer and viral videotrepreneur Kevin Nalty to lead a new division dedicated to policing online marketing.
 
"The Internet is great for porn, toilet humor and cute pictures of small, furry animals," said Nalty, "but disseminating information about prescription drugs? People, trust me -- stick to fart jokes and we'll all get along just fine."


Doctors want more freedom to practice: new survey
 
 
A new survey of 1,000 doctors in four countries has revealed high levels of dissatisfaction with levels of freedom in deciding how to treat patients. The survey was conducted by Medicine and Liberty, an independent, non-partisan physician network, based in Switzerland.
 
The survey, conducted amongst surgeons and general practitioners in the US, Germany, Singapore and Switzerland, showed that 70% of doctors consider professional autonomy to be one of the most important elements of proper patient care, but 62% of German and 47% of US doctors are strongly dissatisfied with their levels of freedom to choose the prescriptions, treatments and procedures that they consider most appropriate. In the predominantly private insurance-based healthcare systems of Singapore and Switzerland, levels of dissatisfaction with treatment freedom are far lower (9% and 17%).
 
Only 35% of doctors across the four countries felt they were able to treat their patients as individuals rather than statistics.
 
Many doctors feel that government regulations unnecessarily hinder their treatment options. 52% of German doctors, 49% of US doctors and 38% of Swiss doctors are in favour of the complete abolition of government regulation of prescriptions of medicines or procedures—providing those medicines and procedures conform to established norms regarding safety and side effects.
 
Other doctor complaints centre around amount of time devoted to administrative details and paperwork (69%); handling of malpractice lawsuits in the courts (52%) and costs of malpractice insurance (51%); the amount of time and bureaucracy involved in government approval of new medicines and treatments (45%).
 
However, doctors in the US and Switzerland are far more satisfied with the overall quality of healthcare (64% and 75%) than their colleagues in Singapore and Germany (29% and 30%).
 
Dr Alphonse Crespo, director of Medicine & Liberty, and Swiss orthopaedic surgeon commented: “This survey should serve as a warning to governments who are seeking to
centralise and mandate new healthcare regulations in the name of cost containment. US proposals such as a federal Comparative Effectiveness Research Agency, and German and Swiss plans to exert more government control over treatment guidelines, strike at the heart of physician autonomy. Ultimately, it will be patients who pay the price of such short-sighted policies.”  
 
----------------------
Notes for editors:

The study was commissioned by Swiss organisation Medicine and Liberty, and was conducted by the Consensus ResearchGroup, Inc. A total of 1,000 doctors surgeon and general practitioners (65%) in the four countries were interviewed via an online questionnaire. The questions covered topics from how the role of doctors in society, the influence of insurance companies on the doctor-patient relationship to access to medical innovations. The interviews were carried out between August and September 2010.
 
 
About Medicine & Liberty: www.medlib.ch
 
 

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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