In Vitro Veritas

04/13/2012 07:24 AM |

In Vitro Veritas

A renegotiation of the EMA (European Medicines Agency) medical devices directives is imminent.  Our spies tell us that, for in vitro diagnostics, a line will be drawn between tests used as companion diagnostics -- where clinical evidence of their applicability will be required -- and other in vitro tests such as PSA for prostate cancer -- where no such evidence will be required.

Uneasy lies the head that wears a crown

Eric Abadie, the chair of CHMP (The Committee for Medicinal Products for Human Use) has resigned -- another victim of L’Affaire Mediator (the French anti diabetic /anti obesity drug remained questionably available in France and killed somewhere on the order of 5000 patients from pulmonary valve disease). The French Agency sacked him and the EMA opted not to pick up his salary.

Meanwhile on our own placid shores

Here’s an excellent article from the April edition of Nature Biotechnology on some of the key policy questions facing the US biotech sector pending PDUFA and presidential politics.

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First Person Risk Benefit

04/12/2012 08:19 AM |

Part of the FDA’s promise for PDUFA V is a more patient-centered approach to risk/benefit analysis. A timely new analysis provides a closer look at how much cancer patients value hope --with important implications for how insurers value treatment, particularly in end-of-life care.

The analysis by Darius Lakdawalla, director of research at the Schaeffer Center at USC and associate professor in the USC Price School of Public Policy, surveyed 150 cancer patients currently undergoing treatment, and is part of a special issue on cancer spending from the journal Health Affairs.

Lakdawalla and his co-authors found the overwhelming majority of cancer patients prefer riskier treatments that offer the possibility of longer survival over safer treatments: 77 percent of cancer patients said they would rather take a “hopeful gamble” — treatments that offer a 50/50 chance of either adding three years or no additional survival — to “safe bet” treatments that would keep them alive for 18 months, but no longer.

“Consumers tend to dislike risk, and researchers and policy makers have generally assumed that patients care about the average gain in survival,” Lakdawalla said. “But patients facing a fatal disease with relatively short remaining life expectancy may have less to lose and be more willing to swing for the fences. This analysis points to the larger ideal — that value should be defined from the viewpoint of the patient.”

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Drug Shortages and GPOs

04/11/2012 08:41 AM |

Reaching the wrong conclusion only makes a problem worse. Witness drug shortages and a bill pending in Congress that would require drug manufacturers to notify federal officials of a disruption to a drug supply six months in advance.

In theory, such a requirement would give the FDA an opportunity to prevent the shortage, notify health-care providers and develop a contingency plan. In reality, that’s not the problem.

 “What we’re trying to find out is whether there’s a pattern behind the shortages that we can address,” comment senator Richard Durbin (D, IL). “We’ve got to get down to what is really behind it and try to solve it.”

Precisely.

While earlier and more robust communications between drug manufacturers (largely generic manufacturers of hospital injectables) and the FDA is important – lack of such interaction isn’t the major cause of the problem. The issue at hand is that that, because of the way hospitals purchase medicines, there is no incentive for drug makers to update manufacturing facilities or build new ones. Hence, when a facility goes off-line due to quality concerns (the major cause of supply line disruption) or is retooled for a different (and more profitable) use – shortages can occur. In such an instance, should a manufacturer advise the FDA of potential shortages? Certainly.

But that’s not the real problem. The unreported problem is the role of Group Purchasing Organizations (GPOs). GPOs control the purchasing of more than $200 billion in drugs, devices, and healthcare supplies annually for some 5,000 private, acute care hospitals nationwide. And they keep costs low. That’s the good news. The bad news is that they are also permitted (by law) to charge a fee to hospital suppliers based on percentage of sales volume for a particular product. And sometimes it’s a hefty one – often as high as 35-50%. That certainly throws a spanner in the supply-and-demand proposition. Six months supply at ever-lower margins becomes a non-starter for many companies – further exacerbating the problem rather than solving it.

GPOs are a monopsony (a buyer’s monopoly) dominated by six firms that control about 90% of the goods purchased by hospitals via GPOs. The power of these organizations is such that they can often dictate which drugs, devices and supplies are used in hospitals – and which companies are allowed to sell them.

These practices have created a concentrated market that excludes other existing and would-be suppliers and distributors. So, with no other suppliers able or available to fill the gap, increases in demand for generic drugs have resulted in shortages and surging prices. It is no coincidence that the problem is generally limited to generics sold to healthcare facilities through GPO contracts rather than directly to consumers through retail pharmacies.

GPOs have their critics. Among them is former Wall Street Journal reporter Phil Zweig who writes that, “GPOs have concentrated production of generic drugs in a handful of drug makers and have forced some manufacturers to cease production of various lifesaving drugs altogether and distributors to slash inventories to the bone. In a nutshell, these cartels have undermined the laws of supply and demand in this critical industry.”

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IOM signs on to Regulatory Marshall Plan

04/10/2012 08:45 AM |

It’s time to actively and aggressively pursue FDA Commissioner Peggy Hamburg’s call for a regulatory Marshall Plan to help build, nation-by-nation, global systems for both quality and safety. A high tide floats all boats.

A new IOM report concludes the FDA should invest in advancing the regulatory capacity of developing low and middle income nations in order to secure the pharmaceutical supply chain and safeguard the American public.

The report, Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad, recommends 13 steps FDA and other regulatory bodies can take in the next five years to improve the regulatory systems of developing nations.

Rather than try to inspect all foreign establishments itself—something IOM conceded was unrealistic given FDA’s limited budget—FDA should instead invest in improving other regulatory systems to accomplish its goals of ensuring a safe pharmaceutical supply chain.

After all, as Peggy Hamburg has repeatedly said, ““We can’t inspect our way out of this problem."

The IOM reports, “The FDA should use partnerships to drive improvements in supply chain management. The committee recommends that the FDA work with strong regulators in other countries to plan inspections and pool data. There is no need for American and European inspectors to duplicate each other’s work, especially when a vast number of facilities go uninspected … One promising initiative is the two-year FDA Secure Supply Chain pilot program, which rewards firms that trace their products thoroughly from manufacture to entry into the United States.”

 “The report urges FDA and its technologically advanced counterparts in the European Union, Canada, Japan, Norway, Iceland, Switzerland, Australia, and New Zealand to plan a system for mutual recognition of one another's inspections, which would eliminate the wasteful duplication of effort,” wrote IOM in a statement.

FDA, the European Medicines Agency (EMA), Australia’s Therapeutic Goods Administration (TGA) and the World Health Organization have all announced their participation in a global active pharmaceutical ingredient inspection program that might go a long way toward accomplishing IOM’s recommendations—something IOM agrees with in principle.

IOM also called on industry association to “define a reliable way to share internal inspection results among their members within the next three years.

With scare resources, perhaps the best place to start is by committing to common standards for data capture and reporting.

After all, knowledge is power.

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If a tree falls in the forest ...

04/09/2012 07:44 AM |

It is rare that the words “progress” and “Alzheimer’s Disease” are used (positively) in the same sentence.

Maybe that’s about to change.

Last week the EMA's CHMP adopted a qualification opinion that positive/negative PET imaging of amyloid can be used as a biomarker to identify patients in clinical trials with predementia Alzheimer's disease (AD) who are at increased risk to have an underlying neuropathology. Now an Eli Lilly & Co. diagnostic that detects the presence of proteins in the brain that are related to Alzheimer's disease is FDA-approved.

According to a report in the Wall Street Journal, “The tool could enable clinicians to detect Alzheimer's earlier and more accurately in patients at the earliest sign of memory problems—a potential boon to treatment and developing drugs against the disease.”

A lack of ability to reliably diagnose patients in the early stages of the Alzheimer's disease has hampered research. Some experts believe that investigational drug trials have failed because patients enrolled in such studies already had progressed too far for the treatments to be effective.

Proponents of using florbetapir and similar agents that are being developed have said that such technology will accelerate research by helping to accurately identify people at high risk of developing the condition and to enroll such people in therapeutic trials.

The test uses a chemical called florbetapir, known by the brand name Amyvid, which is a radioactive agent that tags clumps of a sticky substance called an amyloid. Amyloid proteins are hallmarks of Alzheimer's disease. The chemical, which costs $1,600 per dose, then is detected using a brain imaging technique called positron emission tomography, known as PET scans.

The Journal raises an important point, “Some experts have questioned how useful the test is since no treatments are available that significantly alter the course of the disease. But some doctors believe that patients may find a diagnosis helpful for planning purposes or just to know for certain that they have Alzheimer's.”

Question – will payers pay?

If a tree falls in a forest …

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Remember when

04/06/2012 08:39 AM |

BioCentury reports:

EMA backs AD biomarkers

The EMA's CHMP adopted a qualification opinion that positive/negative PET imaging of amyloid can be used as a biomarker to identify patients in clinical trials with predementia Alzheimer's disease (AD) who are at increased risk to have an underlying neuropathology. CHMP also adopted a qualification opinion that the combination of low beta amyloid (1-42) and high tau in cerebrospinal fluid (CSF), and amyloid-related PET imaging, can be used to identify patients with mild to moderate AD who are increased risk of an underlying AD neuropathology. CHMP said the biomarkers are intended to enrich recruitment in trials aimed at studying products to slow the conversion to AD or severe AD.

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HELP is on the way

04/05/2012 07:47 AM |

The Health, Education, Labor and Pensions Committee released a discussion draft of legislation aimed at accelerating patient access to innovative medical treatments for life-threatening diseases.

The bipartisan Drug Approval and Patient Access Plan would overhaul the FDA's Accelerated Approval pathways and create a new "breakthrough" designation to provide more flexibility and certainty for developers of new medicines intended to address serious or life-threatening diseases or conditions.

The draft includes legislation introduced last week by Sen. Michael Bennet (D-Colo.) that would expedite FDA approval and provide more flexibility when a drug or treatment shows dramatic responses early in development.

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Taking Pediatric Medicines Development off the 5 Year Plan

04/04/2012 07:55 AM |

We called it.

At CMPI’s November PDUFA without the Politics conference, each panelist was asked to bring one ornament to hang on the reauthorization Christmas Tree.  Tim Franson (President of the USP Convention and one of the “Fathers of PDUFA”) offered a little lifeboat.

What can we do for those with life threatening unmet needs? One thing, as was done in PDUFA IV, is adding renewal of the Best Pharmaceuticals for Children’s Act. That piece of legislation has done more for pediatric drug development than anything in the past. It’s been good for American children and it should be made permanent. I think the better policy argument is to make it permanent, because companies don’t invest in five-year cycles. (Note to reader: The Act is currently renewable every five years.)

If I’m looking for a return on an investment, I need certainty well in advance of five years on types of studies I should be conducting and I need to know the benefit I’m getting at the end. I think five years is far too short a period of time.

There’s an accumulated body of evidence, of companies fulfilling their commitments. Maybe its time we make it permanent. I think this point of holding up renewal like the Sword Damocles isn’t very persuasive even to sponsors.

Well, a bipartisan House bill now proposes to permanently reauthorize two pediatric-drug statutes that include marketing incentives and clinical-study mandates, which the drug industry supports, while also giving FDA recourse for unfinished pediatric studies and requiring drug sponsors to submit their plans to the agency earlier, measures advocated by pediatricians.

Reps. Ed Markey (D-MA), Anna Eshoo (D-CA) and Mike Rogers (R-MI) introduced the bill to permanently reauthorize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.

The bill would require drug makers to submit an initial pediatric-study plan by the end of phase 2 clinical trials. Currently, companies must submit the information when they submit an application or supplement to the agency. FDA must promulgate a rule and guidance on the new timing requirement, according to the bill. The plan should include an outline of proposed studies and any request for a waiver to defer the requirements.

Lawmakers backing the bill said the pediatric laws have led to pediatric studies for 180 new drugs and more than 400 updated drug labels.

“Government and private industry have worked together to fill an important void,” Eshoo said in a statement. “The laws have provided greater transparency and accountability in the programs, while improving communication between FDA and companies. I’m proud of how far we’ve come and look forward to a day when we know how all medicines will affect children.”

Now sponsors are looking for a little HELP.

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One man's ceiling is another man's floor

04/03/2012 07:51 AM |

In recent statements ANVISA, the Brazilian equivalent of the FDA, has put forward the proposition that (relative to raising the level of international drug quality and safety) there isn’t a way forward but rather “ways to move forward based on local situations.

While the solution must fit the problem, this poses an interesting question – can there be a floor and a ceiling for global drug safety and quality? Even as we move toward differential pricing, should we allow some countries to have lower standards than others “based on local situations?”

When it comes to the safety of pharmaceuticals and medical devices, can one man’s ceiling be another man’s floor.

And how does this fit into the debate over trade policy versus trade practice? Should medical products that are determined not to meet any given national standard be allowed to be exported to other countries? Should there be a “good enough for me, good enough for thee” standard for international trade in pharmaceuticals and medical devices?

For example, should Beijing allow substandard API -- illegal for use in the Middle Kingdom -- to be exported to, say, Nigeria?

When Paul Orhii, Director-General of Nigeria’s National Agency for Food and Drug Administration and Control, complained to the Chinese government that China was the origin of many of the counterfeit medicines in Nigeria, he was bluntly told Beijing was not responsible for the quality of medicines in Nigeria.

That’s the unfortunate distinction between trade policy and trade practice. Is this an issue for TRIPS? Should TRIPS Article 61 be amended to include punishments and penalties for those who export medicines and medical devices that do not meet a certain global standard?

While domestic standards are undeniably an issue of domestic sovereignty, shouldn’t there be transparency as to how any given nation defines safety and quality? “Market authorization” means one thing in the context of the MHRA, the FDA, the EMA, and Health Canada (to choose only a few “gold standard” examples), but how are we to judge the regulatory competencies of other national systems? Is that the responsibility of the WHO via a better-developed (and far more transparent) pre-qualification scheme? Or regional arbiters (such as PAHO)? Should there be “reference regulatory systems” as there are reference nations for pricing decisions? Should there be regulatory reciprocity?

All the more reason for “gold standard” nations to undertake a regulatory Marshall Plan to help build global systems for drug quality and safety.

The harmonization of global trade policy and practice is essential to the sinews of international medicines quality and safety.

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Is Obamacare Doomed?

04/02/2012 10:42 PM |

Even If It Survives the Court, the Health Care Law Is Doomed By Scott Rasmussen Media coverage now implies that the U.S. Supreme Court will determine the fate of President Obama's health care law. But nothing the court decides will keep the law alive for more than a brief period of time. There are three ways the health care law could meet its end. The first, obviously, is the Supreme Court could declare some or all of it unconstitutional in June. If it gets past that hurdle, the law also could be ended by Election 2012. If a Republican president is elected, the GOP will almost certainly also win control of the Senate and retain control of the House. While the details might take time, a Republican sweep in November would ultimately end the Obama experiment. But even if the law survives the Supreme Court and the next election, the clock will be ticking. Recent estimates suggest that the law would cause 11 million people to lose their employer-provided insurance and be forced onto a government-backed insurance plan. That's a problem because 77 percent of those who now have insurance rate their current coverage as good or excellent. Only 3 percent rate their coverage as poor. For most of the 11 million forced to change their insurance coverage then, it will be received as bad news and create a pool of vocally unhappy voters. Additionally, the cost estimates for funding the program are likely to keep going up. Eighty-one percent of voters expect it to cost more than projected, and recent Congressional Budget Office estimates indicate voters are probably right. But it's not the narrow specifics and cost estimates that guarantee the ultimate demise of the president's health care plan. It's the fact that the law runs contrary to basic American values and perceptions. This, then, is the third hurdle the law faces: Individual Americans recognize that they have more power as consumers than they do as voters. Their choices in a free market give them more control over the economic world than choosing one politician or another. Seventy-six percent think they should have the right to choose between expensive insurance plans with low deductibles and low-cost plans with higher deductibles. A similar majority believes everyone should be allowed to choose between expensive plans that cover just about every imaginable medical procedure and lower-cost plans that cover a smaller number of procedures. All such choices would be banned under the current health care law. Americans want to be empowered as health care consumers. Eighty-two percent believe that if an employer pays for health insurance, the worker should be able to use that money and select an insurance product that meets his or her individual needs. If the plan they select costs less than the company plan, most believe the worker should get to keep the change. It's not just the idea of making the choice that drives these numbers, it's the belief held by most Americans that competition will do more than government regulation to reduce the cost of health care. For something as fundamental as medical care, government policy must be consistent with deeply held American values. That's why an approach that increases consumer choice has solid support and a plan that relies on mandates and trusting the government cannot survive. COPYRIGHT 2012 SCOTT RASMUSSEN  Read More & Comment...

The Supreme Court and the Individual Mandate

04/02/2012 02:45 AM |

A lively discussion on the US Supreme Court and health care reform on "This Week":


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Drug Co-Pays and Asthma Rates

03/30/2012 06:44 PM |

I am quoted in this piece published in Medscape..

http://www.medscape.com/viewarticle/761255
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NRDC Rejects Science

03/30/2012 06:33 PM |

The gap between science and the National Resources Defense Counci's fearmongering is growing at an exponential rate.  Watch as NRDC pushes a legislative BPA ban and links it to their fundraising operation... 



http://www.nrdc.org/media/2012/120330.asp

FDA Rejects NRDC Call to Eliminate BPA from Food Packaging
NRDC: ‘FDA Fails to Protect Our Health and Safety’

WASHINGTON (March 30, 2012) --  The Food and Drug Administration said today it would allow bisphenol A (BPA) to remain in food packaging, an action that keeps the hormone-disrupting chemical linked to cancer, obesity and a host of other health problems in the food supply.

In rejecting a petition today from the Natural Resources Defense Council, the agency emphasized it was not making a final determination of BPA’s safety and instead will continue to examine the ongoing research of BPA’s effects on health.

The following is a statement from Dr. Sarah Janssen, senior scientist in the public health program at the Natural Resources Defense Council:

“BPA is a toxic chemical that has no place in our food supply. We believe FDA made the wrong call.

“The agency has failed to protect our health and safety ­ - in the face of scientific studies that continue to raise disturbing questions about the long-term effects of BPA exposures, especially in fetuses, babies and young children.

“The FDA is out-of-step with scientific and medical research.  This illustrates the need for a major overhaul of how the government protects us against dangerous chemicals.”
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Pharma's Social Media Hunger Games

03/30/2012 08:49 AM |

Last week, at the PMRG (Pharmaceutical Marketing Research Group) Annual National Conference, I participated on “The Coming of Age of Social Media and Healthcare” panel.

My fellow panelists were the always pugnacious Arnie Friede, UBC’s Pat Choumitsky, and Eric Schultz of QuantiaMD. The session was ably moderated by Mark Bard, the grand master of the Digital Health Coalition.

(Panel description and panelist bios can be found here.)

A few thoughts on the subject that arose from this event:

How many times have you heard (vis-à-vis social media and healthcare) that, “Pharma is different.” That’s true – but consumers are the same. They don’t think about why Pharma is absent from the conversation – and they don’t care.  They assume it’s because the industry “has something to hide” or that they’re afraid of mixing it up with real people in real time.

And there’s more than a little truth to that.

Is social media about “collaborating” with consumers or “cooperating” with them?  What’s the difference?  Well, cooperation happens when both sides want to survive.  Collaboration happens when they want to thrive. Collaboration means interacting honestly and transparently. And Pharma’s opportunity (within the context of social media) is to be the first among equals.

Otherwise social media becomes the healthcare Hunger Games.

Success for Pharma in social media will come through collaboration. And that doesn’t mean “selling.”

And may the odds be ever in your favor.

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The other healthcare hearing

03/29/2012 11:23 AM |

In the midst of all the hoopla surrounding SCOTUS and the Affordable Care Act, let’s not forget today’s Senate HELP hearing on PDUFA.

For those who want to follow this important conversation, follow the twitter feed @modernmeds for the blow-by-blow.

Who said healthcare policy was dull?  Read More & Comment...

My Wish For Obamacare

03/29/2012 10:56 AM |

MARCH 29, 2012 4:00 A.M.
High Court Hopes
(Page 3 of 7)
By NRO Symposium

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JOHN FUND
One of the least-noticed mistakes made by the Obama administration in its arguments for its health-care law this week was the claim by Solicitor General Donald Verrilli that Congress had passed Obamacare to deal with a pressing national problem only “after long study and careful deliberation.” I’m told that even liberal lawyers in the courtroom had pained looks on their faces at that preposterous assertion.

Certainly the general public doesn’t buy that argument, as indicated by the polls. I doubt many lawyers do either. Congressional leaders bullied members into voting for the measure in the dead of night, blatant payoffs such as Nebraska’s “Cornhusker Kickback” and Florida’s “Gatoraid” were handed out, and members were given almost no time to absorb the bill’s 2,700 pages (leading House speaker Nancy Pelosi to say, candidly, “we have to pass the [health-care] bill so that you can find out what is in it.”) At least one Supreme Court justice is said to be astonished that process was so sloppy that Congress left out the traditional “severability” section, which routinely allows that should the courts strike down part of a law the rest would stand.

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Indeed, the third day of oral arguments in the Supreme Court brought a mild surprise: At least five of the justices are considering repealing all of Obamacare, either because the task of figuring out which parts can work absent an individual mandate is too onerous or they don’t believe Congress would have passed the bill without the mandate. In other words, the Court just might take the extraordinary step of sending Congress a stiff rebuke: that its recklessness and sloppiness in lawmaking should have some limits.
Randy Barnett, the Georgetown law professor who has bravely pushed the legal arguments against Obamacare with bulldog tenacity for two years, summed up what has been a good week for the law’s critics: “After these arguments, if the Court strikes down the Affordable Care Act, no one in the country will be surprised.” Indeed, if it happens, a majority of Americans will be relieved. And the battle over putting back some serious curbs on Congress’s ability to run roughshod over the Constitution will then begin in earnest.

— John Fund, a New York writer, is author of Stealing Elections: How Voter Fraud Threatens Our Democracy.


This is my contribution to today's  http://www.nationalreview.com  on-line discussion about how the Court should rule and what should the political response to it's decision (or the decision we hope for) be.  


I hope the Court rules Obamacare unconstitutional. The fact that Congress had many other ways to expand insurance pools has undermined the necessary and proper claim for the mandate. As Roger Vinson noted in his district court ruling, “While the individual mandate was clearly ‘necessary and essential’ to the Act as drafted, it is not ‘necessary and essential’ to health care reform in general.” The mandate is a way to redistribute premium revenue from the young and healthy to other groups. Under Obamacare, it is possible to pay the penalty and use the free emergency care that must still be provided under current law. I think all the judges regard Obamacare as unconstitutional and a failure.

If the Court overturns the law, Obamacare again becomes an issue. Supporters will warn that young people will lose coverage under their parents’ plan and that this will undo community rating. Opponents will be able to say the ruling stops a tax increase, blocks the indirect tax Obamacare imposed on people forced to buy the amount of health-care coverage deemed necessary by government, and pulls the plug on rationing. I hope legislators introduce a market-based reform plan that makes low-cost coverage available. If Obamacare supporters want to reintroduce the law with higher taxes and more regulation, let them.


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Look MAA, no hands

03/28/2012 08:17 AM |

Two important news items courtesy of BioCentury:

The first concerns the necessary and timely updating of how the FDA determines risk/benefit for medical devices.

Final FDA guidance on risk-benefit determinations for devices

FDA released final guidance that seeks to clarify how the agency determines the risk-benefit profile of a medical device during a premarket review. The guidance, which is in line with a draft released last August, says that in addition to safety and efficacy, FDA reviewers will consider criteria such as the novelty of the technology, the characterization of the disease and the availability of alternative treatments or diagnostics.

The guidance includes a worksheet that reviewers will use to make risk-benefit determinations during a review. FDA said it is developing training modules to help industry and sponsors understand how the Center for Devices and Radiological Health (CDRH) will apply the guidance. Reviewers will begin applying it to incoming submissions and to submissions already under review beginning May 1.

Of particular interest to those following the agency’s arduous journey in search of a risk/benefit “grid” is how CDRH will both develop and use its “worksheet” and whether or not that document will be public information after a regulatory decision is reached. Transparency would certainly go a long way towards holding the Center’s feet to the fire vis-à-vis regulatory predictability and consistency.

And, speaking of consistency, some news from our Regulatory Cousins across the pond.

EMA finalizes guidance on MAA transparency

The EMA and the Heads of Medicines Agencies (HMA) adopted a joint guidance for a Europe-wide approach to identify which information included in an MAA can be publicly released after approval, should a request for access to information be submitted. The guidance is part of EMA's policy to increase transparency and access to documents, which came into effect in 2010.

According to the guidance, sections of an MAA dossier that would not be released include detailed information on manufacturing processes and synthesis of the active ingredient, as well as contractual agreements. In general, reports on non-clinical and clinical trials, including efficacy and safety trials, would be made available, although exceptions may be considered when innovative study designs or analytical methods have been used. Identifiable patient information would be redacted. Scientific advice received by a sponsor on an agreed indication would be available, while advice related to new developments and formulations would remain confidential.

(For you Yanks, “MAA” = “Marketing Authorization Application.”)

This is interesting for a number of reasons, let me mention two. First, it points to the ability to harmonize across borders. Need an ocean separate us from this concept? And, second, is this at all predictive of where the FDA might go relative to “going public” with redacted Complete Response Letters?

Inquiring minds want to know.

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CMPI in the Washington Times: Drugs of Choice

03/27/2012 09:29 AM |

Next week, the FDA will be holding a hearing about letting consumers buy commonly used prescription drugs without a prescription, signaling FDA recognition that empowering consumers to make health care choices is the key to better health at a lower cost. The agency’s proposal is a refreshing departure from the usual administration’s practice of expanding government’s role in our daily lives. Yet so-called consumer groups that want the government to tell Americans how to eat, what cars to drive and what medicines to take are opposing even this small step toward medical freedom.

Indeed, the FDA proposal recognizes that individuals, armed with increasingly individualized information on what’s best for them, can make better decisions than a system where what is spent on health care is determined by bureaucrats. More consumers want more personal responsibility and freedom in making health care decisions, not less. They want to spend less time and money on medical care. So why would some groups oppose making more medications that have been widely used for years - for such conditions as high cholesterol, migraines, and hypertension - more accessible?

Groups such as the Center for Science in the Public Interest and Public Citizen claim the FDA proposal will “permit” people to use more medicines without solid information. On the contrary, the explosion of diagnostics, applications and online communities has increased our ability to responsibly take control of our health and well-being. In today’s digital world, we can use our smartphones to obtain test results and access information tailored to our diagnosis, genetics, health goals and lifestyle. Making drugs for osteoporosis prevention, birth control, migraines, cholesterol and erectile dysfunction available without a prescription would, with appropriate safeguards and new health-information tools, empower people to look after themselves. In fact, evidence shows that moving prescription drugs over the counter (OTC) helps people stay on track with their treatment regimen.

Critics often point to what they claim is misuse of cough medicines as an argument for more FDA regulation of OTC products, not less. But a recent survey I conducted on how American families treat coughs and colds underscores the opportunity self-care can offer to improve health. Over the past year, 61 million consumers avoided missing work, school or other scheduled appointments due to illness because they had access to OTC cough medicines to alleviate their symptoms. And nearly 75 percent of all consumers surveyed complemented cough and cold medicine use with rest, fluids (including chicken soup) and other “home” remedies.

The nearly a third of patients who see a physician for a cold wind up spending $7 billion on office visits and another $2 billion on antibiotics a year even though antibiotics don’t work for such ailments. If we were all forced to run to the doctor and get a prescription every time we coughed or were stuffed up, we would be spending a lot more money treating symptoms that can be alleviated effectively by OTC medicines in our pharmacy or supermarket and, more often than not, resolve on their own.

So why do some groups want to keep Americans shackled to our current system of care? As Eric Topol notes in “The Creative Destruction of Medicine,” access to our “own data and information - whether it be DNA sequence or biosensor remote monitoring - will soon be unprecedented, and surely each individual has more at stake about his or her health than the busy physician who is looking after hundreds to thousands of patients … But change cannot take place unless consumers are the driving force.” Without the ability to conveniently access and use more medicines we know and trust in tandem with such valuable personal health information, the paternalism of the present health care system will prevail. Opponents of the FDA proposal are afraid of losing control over our lives.

There is wisdom in the crowd. The benefits of consumer empowerment outweigh the risks that, in fact, can be managed mostly by we the people by educating each other. Turning more prescription medicines into OTC products not only saves time and money. It enhances our ability to sustain health rather than just treat disease.

Illustration: Dangerous drugs by John Camejo for The Washington Times  Read More & Comment...

New Evidence on the Effect of The Individual Mandate On Seniors

03/27/2012 09:22 AM |

Under-treatment is a result of government health systems undervaluing us as we get older and are faced with life threatening illnesses.   And it's a product of 1.  using comparative effectiveness research to guide reimbursement and treatment decisions and
2.   the fact that CER standards and information is not only controlled by government but used in 'academic detailing' of doctors while private companies are banned to discuss new treatments..


UK elderly "being denied cancer treatment"

LYNNE TAYLOR


Under-treatment is one of a number of factors contributing to around 14,000 avoidable cancer deaths in patients aged over 75 in the UK every year, according to a new report.

Cancer mortality rates are getting significantly better for the under-75s, but they are improving at a much slower rate in those aged 74-84 and actually getting worse for people aged 85 and over, says the study, from Macmillan Cancer Support.

PREDICT charter underlines trial bias against older people
The number of people living with a cancer diagnosis is set to rise from two to four million in the next 20 years, and, with half of all new cancer cases in the UK diagnosed in people aged 70 or over, this is an issue which must be addressed as a matter of urgency, says Macmillan.

According to the report, some of the reasons why older patients are less likely to receive treatment than those who are younger include:
- recommendations on treatment are too often being made on the basis of age, regardless of how fit patients may be;
- assessments do not adequately measure an older person's fitness for treatment, and co-existing health problems are often not identified or effectively managed;
- many patients do not take up treatment because they have inadequate practical support to help them at home, with transport, or with care for dependent spouses and other family;
- older people are not represented on enough clinical trials, reducing the amount of evidence available to clinicians on the benefits and risks of cancer treatment and its impact on quality of life: and
- oncologists and cancer surgeons need more support to manage issues specific to older people such as falls, incontinence and multi-drug use. In a survey of 98 oncology trainees, 60% reported that they have never received any training in the particular needs of older people with cancer, despite them making up half of numbers getting cancer each year, the study reports.
"To deny older patients treatment that could cure them based on ill-founded assumptions is an unacceptable act of discrimination," said Ciaran Devane, chief executive of Macmillan Cancer Support.

"We have a moral duty to treat people as individuals and give them the best chance of beating cancer, regardless of their age," he stressed.
"Efforts are begin made to increase early diagnosis and promote healthier lifestyles, but much more needs to be done to tackle under-treatment. The NHS and social care providers must wake up to the specific issues older people face and ensure treatment decisions are based on their overall health, not just their date of birth," said Mr Devane, adding: "writing people off as too old for treatment is utterly shameful."

Added Professor Riccardo Audisio, consultant surgical oncologist at St Helen's Hospital: " it is despicable to neglect, not to offer, not to even go near to the best treatment option only on the simple basis of the patient's age. This has been a horrible mistake that, particularly in the UK, we have suffered from."
Macmillan has, in partnership with Age UK and the Department of Health, set up five pilots to test new models of older people's care. They will report in December this year.

- Meantime, the National Cancer Intelligence Network (NCIN) reported yesterday that almost 10% of bowel cancer patients die within a month of being diagnosed, and of these 56% are over 80% years old, while 60% have been diagnosed following an emergency admission to hospital  Read More & Comment...

Give me Liberty or Give me Teva

03/27/2012 08:08 AM |

A new study by CVS Caremark shows that Massachusetts residents with chronic conditions are more likely than residents of all other states to take generic medication.

Alaska ranks last in terms of patients who obtain the maximum allowable amount of medicine with each refill, New Jersey ranks last with just 57.8 percent of prescriptions filled with generic drugs, and New Mexico ranks last when measuring patients who refill their prescriptions as directed.

According to CVS Caremark, the failure of patients to adhere to their prescriptions layers $290 billion in unnecessary health costs onto a health care system that is crushing federal and state budgets with little sign of abating.

Per CVS Caremark, use of generics is a critical component in determining whether patients are sticking to their prescription regimen because the cost of brand-name drugs can be a deterrent. Patients also tend to stick to mail-order prescriptions more closely than they do to prescriptions they need to pick up at retail outlets.

More than half of Americans suffer from a chronic disease, contributing to 75 percent of the country’s health care costs.

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