Mistress and Commander

06/01/2011 01:46 PM |

Genentech will be allowed to discuss its proposal for a new confirmatory trial of Avastin in MBC, including reports of its discussions with FDA's Center for Drug Evaluation and Research concerning that study.

Karen Midthun, the hearing's presiding officer, rejected CDER's bid to exclude evidence of its discussions with Genentech on future Avastin studies. The drugs center contended such evidence is irrelevant to its proposal to withdraw Avastin's accelerated approval for MBC.

According to Midthun, "I have concluded, however, that it is not appropriate to exclude this information from the hearing record. It does not appear that CDER disputes the validity of the evidence at issue.”

Genentech recently released on who it will put forward to testify at the June hearing. Chief Medical Officer and Exec VP-Global Product Development Hal Barron will present the overview of Genentech's position, followed by Senior VP and Global Head of Clinical Development for Oncology/Hematology Sandra Horning, who will discuss the clinical data and the proposed confirmatory trial, and James Reimann, global head of oncology biostatistics, who will discuss biostatistics issues.

In addition to the Genentech executives, two oncology researchers will provide "clinical perspectives on the treatment of HER2-negative MBC." Joyce O'Shaughnessy, Baylor Charles A. Sammons Cancer Center, Texas Oncology, U.S. Oncology, has been a lead investigator on a number of breast cancer trials and was formerly a researcher at the National Cancer Institute. Howard A. Burris, III, chief medical officer and director of drug development at the Sarah Cannon Research Institute has published extensively on taxanes.

Finally, Covington and Burling attorney Michael Labson will address regulatory and legal issues.

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Nissen Keeps Missing With Drug Safety Scares

05/31/2011 06:37 PM |

Steve Nissen was hiding under a rock after a study of the protective effects of niacin not only failed to reduce risk but also was associated with a slight increase in CV events.

Here's what the NIH said:

"The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped a clinical trial studying a blood lipid treatment 18 months earlier than planned. The trial found that adding high dose, extended-release niacin to statin treatment in people with heart and vascular disease, did not reduce the risk of cardiovascular events, including heart attacks and stroke.

Participants were selected for AIM-HIGH because they were at risk for cardiovascular events despite well-controlled low-density lipoprotein (LDL or bad cholesterol). Their increased risk was due to a history of cardiovascular disease and a combination of low high-density lipoprotein (HDL or good cholesterol) and high triglycerides, another form of fat in the blood. Low HDL and elevated triglycerides are associated with an increased risk of cardiovascular events. While lowering LDL decreases the risk of cardiovascular events, it has not been shown that raising HDL similarly reduces the risk of cardiovascular events.

During the study’s 32 months of follow-up, participants who took high dose, extended-release niacin and statin treatment had increased HDL cholesterol and lowered triglyceride levels compared to participants who took a statin alone. However, the combination treatment did not reduce fatal or non-fatal heart attacks, strokes, hospitalizations for acute coronary syndrome, or revascularization procedures to improve blood flow in the arteries of the heart and brain...

...The Data Safety Monitoring Board also noted a small and unexplained increase in ischemic stroke rates in the high dose, extended-release niacin group. This contributed to the NHLBI acting director's decision to stop the trial before its planned conclusion. During the 32-month follow-up period, there were 28 strokes (1.6 percent) reported during the trial among participants taking high dose, extended-release niacin versus 12 strokes (0.7 percent) reported in the control group. Nine of the 28 strokes in the niacin group occurred in participants who had discontinued the drug at least two months and up to four years before their stroke. Previous studies do not suggest that stroke is a potential complication of niacin, and it remains unclear whether this trend in AIM-HIGH arose by chance, was related to niacin administration or some other issue. "

www.nih.gov/news/health/may2011/nhlbi-26.htm


Here's what the Prince of Posturing said two years ago...

According to Dr Nissen, ezetimibe "badly failed" the few surrogate outcome studies completed to date. The ENHANCE trial, he recalled, showed a 50 mg/dL greater reduction in LDL-C with simvastatin 80 mg plus ezetimibe 10 mg vs simvastatin 80 mg alone, but no difference in CIMT change. There was even a slight trend toward CIMT progression in the simvastatin plus ezetimibe group. The suggestion that because patients were pretreated with statins, there was too little plaque to observe a differential effect was "nonsense," he said, pointing out that in a similar population in the ASAP trial, a difference of 36 mg/dL in LDL-C lowering was associated with a mean CIMT regression of 0.31 mm.

Dr Brown agreed that ENHANCE was carried out in the wrong population. He noted that many of the patients had been in previous trials for years and had only stopped lipid-lowering therapy for 6 weeks prior to the active phase of ENHANCE, suggesting that they should have had no CIMT to lower. Looking at the same data from ASAP as Dr Nissen, however, he pointed out that all the effect on CIMT was seen in the first year of treatment, which was consistent with the observation that nothing happened in the ENHANCE patients.

According to Dr Nissen, ARBITER 6-HALTS was "equally disturbing, showing a "troubling" decrease in HDL-C and no real change in CIMT with ezetimibe. Again, Dr Brown doubted that the trial was carried out in an appropriate population, since the patients in this trial were at their LDL-C and non-HDL goals at baseline and he would not have chosen ezetimibe for this particular population. He also noted that because the trial was stopped early, some patients (40 on ezetimibe and 35 on niacin) who were still in the study were not analyzed because they had not reached the pre-specified 14-month observation point.

Both presenters noted that there are 2 large trials, SHARP and IMPROVE-IT, underway to examine the effectiveness of ezetimibe in CAD prevention, but neither Dr Nissen nor Dr Brown believes that these are the best trials to answer outstanding questions about ezetimibe. Dr Nissen said he believes that IMPROVE-IT will fail. Dr Brown maintains that a different trial is needed, which he believes would be successful, based on evidence with ezetimibe to date.

Also... 

Dr Steven Nissen (Cleveland Clinic, OH), also commenting on the results for heartwire, called ARBITER 6-HALTS a classic "comparative-effectiveness" study and said there have been calls in the US legislature for such trials for the past few years.

"Now, here it is," he said. "Niacin is a 50-year-old drug, and you can buy it over the counter at your local pharmacy. When you have an inexpensive therapy like this—there are issues about being able to tolerate high-dose niacin, but if you get patients to tolerate it—niacin looks to be a better strategy."
www.theheart.org/article/1022265.do

Notably, Nissen touts he results of the first small study as a great example of comparative effectiveness research.  Ironically, he's right.  Small studies using surrogate measures (most notably the use of ultra-sound to measure thickening of arterial walls, a technique 'invented' and peddled by Nissen) often surprise.  But CER community and it's "stakeholders" had all but hailed the ARBITER study as conclusive. 

Not that Nissen hasn't engaged in fearmongering based on small studies, meta-analysis, etc only to be rebuked by science.  His meta-analysis of CV risk associated with Avandia was undermined by an FDA analysis and the ACCORD study.  (Sadly, he was successful in virtually killing off the drug.)

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Let's Facebook the Music and Dance

05/31/2011 08:29 AM |

From the Journal of Life Sciences:

SOCIAL MEDIA

Facebook to Pharma: Comments Allowed

Social networking site says its pages must be an open forum for conversation.

MARIE DAGHLIAN

Facebook has told pharmaceutical companies that as of August 15, they will no longer be able to disable the comment feature on their Facebook pages. Until now, to control content on their pages, pharmaceutical brands could ask permission to disable commenting on their Facebook pages, citing compliance and regulatory concerns.

Facebook notes that as a social media platform, it is by definition, interactive. When commenting is not permitted, as on many pharmaceutical brand sites, there is no dialogue, defeating the purpose of social media.

The decision could complicate the pharmaceutical industry’s embrace of social media as companies continue to be cautious because of unintended consequences that could arise from its use.

“Everybody in pharma wants to be in social media—second,” says Peter Pitts, president of the Center for Medicine in the Public Interest [www.cmpi.org] and a former associate commissioner of the U.S. Food and Drug Administration. Many of the regulatory issues that Pharma usually brings up are self-imposed, says Pitts. The FDA has not said that pharma can’t be in social media and recognizes it as an important tool for communication.

Drug companies cite no clear direction from the FDA and say they are worried about conversations about adverse events and off-label uses of drugs, but Pitts believes that these conversations can be handled responsibly. “Blaming the FDA for lack of guidance is an excuse for a lack of understanding or even worse, a lack of courage for being in this space,” says Pitts.

Social media’s marketing use should be secondary to its capability to advance public health. Pharmaceutical companies need to be part of this conversation, notes Pitts.

Although pharmaceutical brand pages will no longer be able to disable commenting on their posts, Facebook will, on a case by case basis, allow disabling of the commenting function on branded pages solely dedicated to a prescription drug.

In an email explaining the policy to pharmaceutical companies, Facebook said it thinks the policy changes “support consistency for the Facebook Pages product and encourage an authentic dialogue between people and business on Facebook.”

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Remember the Maine (Medical Association)

05/30/2011 09:46 AM |

Interesting article by Gardiner Harris in today’s New York Times, “As Physicians’ Jobs Change, So Do Their Politics.”

And, although there is a lot of conditional phraseseology (“could mean this,” “could mean that”), it raises some interesting points and is worth some discussion.

Reporters (especially those covering healthcare issues) are keen to say, “The plural of anecdote is not data.” And they’re right. But after leading off with, well, an anecdote, the story continues:

There are no national surveys that track doctors’ political leanings, but as more doctors move from business owner to shift worker, their historic alliance with the Republican Party is weakening from Maine as well as South Dakota, Arizona and Oregon, according to doctors’ advocates in those and other states.

No surveys or facts or figures but, nevertheless, some telling anecdotal trends worth reporting.

Mr. Harris continues,

That change could have a profound effect on the nation’s health care debate. Indeed, after opposing almost every major health overhaul proposal for nearly a century, the American Medical Association supported President Obama’s legislation last year because the new law would provide health insurance to the vast majority of the nation’s uninsured, improve competition and choice in insurance, and promote prevention and wellness, the group said.

Please note the word “would.” The new law “would provide” among other things improved competition and choice. Well, to put it mildly, that remains to be seen.

With the politics out of the way, the article hits the crux of the matter:

Because so many doctors are no longer in business for themselves, many of the issues that were once priorities for doctors’ groups, like insurance reimbursement, have been displaced by public health and safety concerns, including mandatory seat belt use and chemicals in baby products.

Even the issue of liability, while still important to the A.M.A. and many of its state affiliates, is losing some of its unifying power because malpractice insurance is generally provided when doctors join hospital staffs.

But the issue isn’t just money – it’s also physician disempowerment. With first insurance companies and now (and increasingly) Uncle Sam telling doctors how to practice medicine (step therapy, restrictive formularies, an increasing reliance of questionable comparative effectiveness research and more strident and cumbersome preauthorization requirements). It’s no wonder that physicians are leaving private practice.

So it’s highly questionable that physicians (their political affiliations notwithstanding) are going to be fans of the Patient Protection and Affordable Care Act.

And to that point, the article ends … with an anecdote:

Dr. Kevin S. Flanigan, a former president of the Maine Medical Association, described himself as “very conservative” and said he was fighting to bring the group “back to where I think it belongs.” Dr. Flanigan was recently forced to close his own practice, and he now works for a company with hundreds of urgent-care centers. He said that in his experience, conservatives prefer owning their own businesses.

“People who are conservative by nature are not going to go into the profession,” he said, “because medicine is not about running your own shop anymore.”

So, consider the Irish proverb, “Every disease is a physician” – and then consider what disease we’re addressing.

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PDUFA Update: Moon in Seventh House

05/27/2011 07:53 AM |

And, according to the Federal Register,  Jupiter aligns with Mars.

It seems that peace, love and happiness have broken out.

As BioCentury reports:

PDUFA V deal done

BIO and PhRMA have reached a final agreement with FDA on terms for reauthorizing PDUFA, according to sources involved with the negotiations. The final element of the deal, language committing FDA to "promoting innovation through enhanced communication" with sponsors during drug development, was agreed upon this week. Previously agreed elements of PDUFA V include two-month extensions on standard and priority PDUFA review goals, and user fee funding for 119 new FDA staff for regulatory science projects. The five-year PDUFA V cost is expected to be about $3 billion, up from about $2.8 billion for PDUFA IV.

FDA has agreed to adopt a "philosophy statement" committing the agency to "timely interactive communications with sponsors during drug development." A PDUFA V goals letter commits FDA to develop, by the end of FY13, a dedicated staff to liaise with sponsors during the IND process and to train CDER staff on best practices for enhanced communication with sponsors.

The two-month extensions of review goals will provide time for FDA to incorporate two new elements: a status update for sponsors in the middle of a review, and a late-cycle meeting in advance of any advisory committee meeting to present a comprehensive report on the agency's review.

FDA is expected to publicly release the PDUFA V agreement following review by HHS and the Office of Management and Budget, and to hold a public hearing in October. The House Energy and Commerce and Senate Health, Education, Labor and Pensions committees have tentatively scheduled hearings on PDUFA in June.

And in other news of mutual admiration and respect:

Midthun to allow discussion of future Avastin studies at hearing

CBER Director Karen Midthun indicated she will allow Genentech Inc. to present information about future studies of Avastin bevacizumab at a June 28-29 hearing on FDA's proposed withdrawal of metastatic breast cancer from Avastin's label. In a letter to the Roche unit and CDER, Midthun said it is not appropriate to exclude the information since CDER does not dispute the validity of the evidence, only its relevance. She added that she is not prepared to rule at this time on whether or not the information is relevant to the hearing.

Last week, CDER said in a letter to Midthun that it did not believe future studies of Avastin were within the scope of the hearing.

Harmony and understanding?

Is this the dawning of a regulatory Age of Aquarius?

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Jerry Rigged

05/26/2011 12:29 AM |

Per yesterday’s post (“Academic Retailing"), here’s a comment from a highly respected and high priced Inside the Beltway FDA/Regulatory Affairs attorney:

Dude, great piece.  How about a follow up describing the incredible resource intensity of the copy review process and calling on Avorn to have the same thing?  He would need economists, physicians, regulatory people, medical information, and lawyers.  My rate is $850/hr but I might knock off ten percent.  Seriously, I'm sick of critics pretending there's no rigor to company promotion.  They spend hundreds of thousands of hours a year scrutinizing promotional programs and detail aids and ads.  That's not the issue.  The issue is that the government refuses to provide clear rules because it would rather play gotcha.

Indeed.

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Counterweight to CER From Across the Pond

05/25/2011 04:48 PM |

CER advocates and even Patient Centered Outcomes Research Institute committee members push the healthcare system to embrace data-dredging of the lowest form.  See the article from Drug Benefit News where the one size fits all CER crowd extols the virtues of poorly powered head to head studies included in FDA submissions as a 'treasure trove' of data for driving prescribing decisions and guidance.  A study by Joshua Gagne ,Sebastian Schneerweis ( a member of the PCORI methodology committee) are drooling over the possibility of using such data to shape what drugs we can use and when.

The Harvard researchers were taken aback, he says, to discover so many drugs had CER on file. “We were also surprised by how many actually had defective comparator data,” Gagne says. “So even though our study suggested that 70% actually had data available, it doesn’t necessarily guide coverage decisions for 70% of the drugs.”

Note to Gagne and PCORI committee  member Schneerweis: CER is not supposed to be used to guide coverage decisions.  Or maybe they didn't read the statute.

aishealth.com/archive/ndbn051311-04

By contrast the Association of the British Pharmaceutical Industry has published a document for using real world data to guide treatment selection that the PCORI and CER crowd should pay attention to.

www.youtube.com/watch

It takes up to three years after a drug gets approved by Britian's Medicine Agency to get through CER review and onto market.  Are we willing to make such delay part and parcel of health care reform?
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Academic Retailing

05/25/2011 07:18 AM |

“Harvard Academic To Organize Insurance Industry CER Detailing Program” gushes the headline of the article on academic detailing:

 

“A prominent academic at the forefront of comparative effectiveness research pharmaceutical detailing efforts will soon begin seeking support for the establishment of a third-party payer non-profit organization to help physicians receive information on medical therapies from a wider group of experts -- including insurance companies -- as opposed to predominantly from drug manufacturers.”

The “prominent academic?” Why it’s non other than Harvard Medical School researcher Jerry Avorn – the same high-minded and unbiased man of science who said, “Marketing departments of many drug companies don’t respect any boundaries of professionalism or the law.”

 

Untrue and unfair. That’s a pretty broad brush – but Dr. Avorn has never worried about the unintended consequences of hyperbole.

 

(Avorn already established two non-profit groups supported by government funding that help disseminate CER information to doctors. The National Resource Center for Academic Detailing obtains funding from HHS' Agency for Healthcare Research and Quality to help train academic detailers, while the Independent Drug Information Service compiles CER information and is supported by some state government agencies, including the Pennsylvania Department of Aging.)

"I'll be, basically, phoning contacts that I know in the private sector and asking if they would like to engage in this bold adventure together," he told FDA Week.

Well, “bold” may be one word for it.  Another, less flattering adjectival phrase, “intellectually dishonest” – may be more applicable.

(This is the same Jerry Avorn who tried to claim that there was a higher incidence of black box warnings around drugs approved right before user fee deadlines but got caught when Bob Temple and FDA economists found significant, uh, omissions in his database and "rounding" errors that, when accounted, for essentially eliminated any difference in the number of black box warnings.) 

There is little information on why so few AD programs attempt to measure overall healthcare cost reductions.  This is likely due to the fact that measuring changes in prescription drug costs is a more manageable analysis than determining changes in overall healthcare spending. It also (in the calling a spade a spade department) fits into the general cognitive mapping of those who believe that pharmaceutical costs are the main driver of health care costs. (FYI – on-patent drug costs represent less than a dime on the American healthcare dollar.)

I’ve said it before, but it’s worth repeating -- the worst part about rushing headlong into academic detailing is that there is no clear articulation or transparency regarding the specific rules and regulations that will govern the behavior and activities of AHRQ-funded detailers.

Some of those unanswered (and, alas, unasked) questions:

Q: What safe guards are in place to certify that physicians are being presented information that is unbiased? Previous government detailing efforts have often focused on demonstrating their own value by highlighting the cost effectiveness of initiatives through savings generated from the increased utilization of generics and other low cost therapies.

Asked another way – how can an “academic detailing” program funded by our nation’s largest payer be considered neutral? Just like detailing programs run by pharmaceutical companies, there is an inherent “interest.” And that’s okay – as long as that “interest” is transparent.  But “academic” it ain’t.

Q: What information is worthy of being detailed by these programs?  Who decides and on what basis?

Q: What can they say or not say?  Who decides? Will they have to play by the same rules as pharmaceutical representatives?  And, importantly, what is the oversight mechanism?  If academic detailers stray into off-label conversations, to whom does DDMAC send a letter?  Whom does the Department of Justice investigate? Who pays the fine?

All this to say that, if academic detailing is the answer – what’s the question?

As the old Crazy Eddie commercial asked, “What’s the story, Jerry?”

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Information is in the eyes of the beholder

05/24/2011 08:24 AM |

What’s the difference between “advertising” and “information?”

Consider the interesting (but somewhat byzantine) decision from the Court of Justice of the European Union (CJEU) on the “advertising” of medicines.

The Pink Sheet reports that the ruling in MSD Sharp & Dohme GmbH v. Merckle GmbH, handed down on May 5, “seeks to define the boundaries of acceptable information provision so that compliant manufacturers of prescription medicines can avoid accusations of engaging in direct-to-consumer advertising. DTC is both illegal and unwelcome in the EU, the European Commission has time and again stressed.”

The decision is restrictive -- allowing companies to provide objective information that will in no way lead directly to a decision to purchase, leaving firms with few options beyond essentially providing the labeling online.

 "A different classification must, however, be adopted where the information relating to the medicinal product is selected or rewritten by the manufacturer, since such manipulation of information can be explained only by an advertising purpose," the court said.

MSD had put information on its website concerning its prescription-only products Fosamax (alendronate), Singulair (montelukast) and Vioxx (rofecoxib). (Vioxx was withdrawn worldwide in 2004; the product's presence in the case stems from the long-simmering nature of the dispute.)

MSD's site included images of the product packaging, the therapeutic indication and the leaflet containing instructions for use of the product. This is essentially information contained with the Summary of product Characteristics (SmPC), which a company must file when applying for a marketing authorization.

Merckle complained that this constituted advertising to the public, as the site was not password-locked, and was anti-competitive. The CJEU, to whom the case was referred by the German Federal Court of Justice, dismissed the suggestion behind Merckle's complaint that simply communicating this information was inherently promotional.

Indeed, "the possibility for the patient to access in advance, before a medical examination, objective information from reliable sources could, in some circumstances, contribute to the prescription of appropriate treatment, in so far as there may be a more fruitful dialogue between the doctor and the informed patient," the court wrote.

The European Parliament adopted a position on a Directive on Information to Patients on November 24, 2010. It went before the Council of Ministers' Employment, Social Policy, Health and Consumer Affairs Council on December 6-7, 2010. The Council has asked the Commission to amend parts of the proposal, and the next stages of the political debate will take place after those changes are complete.

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Personalized Medicine Advances

05/23/2011 04:53 PM |

Could it be that the pessimism about the biopharma pipeline is overstated.  In two weeks we had the approval of two new drugs that are effective cures for Hepatitis C and reduce the need for other medicines.   At the same time, a whole slew of new targeted cancer therapies were unveiled at ASCO.   And two new drugs to stop the replication of HIV were approved.

Increasingly, drugs that are approved have the following qualities:  they address an unmet and complex medical need; they are targeted drugs that use diagnostics to identify people who will benefit the most; and they highly effective. 

Meanwhile, members of Congress cannot stop flogging the same silly issues:  Herb Kohl wants all information in drug liability trials to be made public and Jo Anne Emerson and Peter Welch have launched the Congressional Affordable Medicines Caucuc in the House, designed to undermine legal and regulatory framework that still in some fashion support innovation. 

Innovation will prevail but not without help.  R and D productivity needs to be much higher.  And given the important products that are emerging from companies large and small, it would make sense to develop policies to promote better medicine.  But maybe that's too much too ask...


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Our Very Own Thunder from Down Under

05/23/2011 08:47 AM |

It seems that one size does not fit all – even Down Under.

From The Australian and the pen of CMPI Senior Fellow Tim Wilson:

Private health accounts may solve looming health crisis

Structural reform of Australian healthcare financing can cut inequity and promote universal choice as well as universal service delivery.

In a society as wealthy as ours it's understandable that Australians support universal access to healthcare.

But accepting this principle and the current one-size-fits-all structure of Medicare are different.

Under the current structure only those who can voluntarily afford to opt out of the system have real choice.

For the rest of us the government predominantly picks up the tab through wholly taxpayer-funded visits to local GPs and hospitals with restricted choices.

With only some services requiring co-payment most Australians have no real understanding of how much healthcare costs, armed only with anecdotal stories of nightmare scenarios faced by travelers in the United States' messy pseudo-public/private system.

But healthcare in Australia is expensive as well. And it’s going to become more so.

According to the latest Treasury Intergenerational report based on 2009/10 dollars the government’s expenditure on total healthcare provision is set to increase three and a half times by the middle of the century.

Considering research consistently finds health expenditure is concentrated in the final months and years of life the looming acute pressure on taxpayers with a dramatically ageing population is quite horrifying.

Today's taxpayers are paying for the managed departure of their grandparents, and there's about to be a lot more of the latter proportionate to the former.

Without reform universal healthcare cannot continue to enjoy funding consistent with current levels of care. As a consequence individuals will either have to pay more or there will be rationing of services universally enjoyed.

It’s essentially the same challenge government faced with the pension resulting in the introduction of compulsory superannuation.

Instead of continuing to provide universal health financing through a top-down government-knows-all-model the government should use the opportunity of this temporary resources boom to restructure our health system toward a bottom-up individual health account system.

Put simply every Australian would have an individual health account that they contribute to on a periodic basis from their income, like superannuation. That savings account would then be used to pay for healthcare services as required throughout their lifetime.

As outlined earlier, considering the bulk of people’s health expenditure occurs at the end of their life people should easily be able to accumulate savings for their final health bill over a lifetime.

The scheme would also need to be complemented with progressive tax cuts as the transfer of the health financing burden shifted from government to individuals.

Healthcare financing accounts for children would need to remain wholly government subsidised since they will not have had the chance to contribute to their own accounts. 

Equalisation subsidies would also be needed for welfare recipients, low-income earners and people with specific diseases to ensure universality and that no one is disadvantaged because of socio-economic status or because they were born with a particular disease.

According to Monash University Academic Just Stoelwinder’s research the Dutch system has working equalization subsidies supporting their compulsory health insurance scheme.

While the intent of health accounts is for individual management through appropriately regulated financial products, the scheme could be designed to allow Australians the choice to take up an insurance alternative to increase service access and pool risk.

The benefits of individual of restructuring Medicare around individual health accounts are manifest.

By engaging patients more directly with the management of their health they’ll come to appreciate healthcare is expensive and discourage inefficient, costly behaviours like the current problems of people using hospitals for primary care.

Individual accounts would also increase private sector involvement to compete with the public sector and create a generally higher level of competition improving patient value.

In his autobiography A Journey Tony Blair identified the essential challenge that "health care systems in which there was a mixed public/private provision, of which at least demand some individual commitment and gave some individual choice, did best".

Choice isn’t always the first priority in healthcare delivery, but it can be relevant in non-emergency situations.

Accounts would discourage information asymmetry between the medical profession and patients because the latter is empowered with choice necessitating greater responsiveness from service providers.

Importantly individual accounts would remove the need for a private health rebate which could instead be redirected to helping healthcare provision for the poor.

Individual accounts would also address through ‘carrots’ the growth in health costs associated with longer lives and lifestyle diseases by promoting preventative healthcare rather than cures.

As the Federal government’s commissioned National Preventative Health Taskforce identified every dollar spent on community-based preventative health delivers a $5.60 "return on investment" within five years and is a no brainer for keeping costs down.

But instead of restructuring the design of our health system as part of the solution they proposed nanny state taxes and regulation 'sticks' to direct consumers away from fast food, alcohol and tobacco consumption.

Under individual health accounts individual choice would be preserved without the need for a nanny state as patients take financial responsibility for the consequences of their behavior.

A well-designed scheme could allow for compulsory contributions to exhaust if an individual’s account reached a certain level where it far exceeded a reasonable projection for a lifetime health costs.

Doing so creates tax cuts for those who actively seek healthy lifestyles.

Structural reform toward individual accounts would be expensive initially to ensure everyone continued to have access to healthcare, but it would be coupled with government savings in the long-run.

More importantly it would drive productivity improvements in healthcare by injecting competition and universal choice that benefits patient outcomes.

Tim Wilson is Director of the IP and Free Trade Unit and Climate Change Policy at the Institute of Public Affairs and a Senior Fellow at New York’s Centre for Medicine in the Public Interest and co-author of The Impact and Cost of Health Sector Regulation.

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Cookbook Karma

05/23/2011 08:19 AM |

First weigh the considerations, then take the risks.

-- Helmuth von Moltke

For you PDUFA junkies, some important reading prior to the upcoming E&C and HELP hearings.

Some snippets from a pre-publication copy …

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II, Board on Environmental Studies and Toxicology Division on Earth and Life Studies, National Research Council, Institute of Medicine

FDA and the Department of Health and Human Services (DHHS) asked the National Research Council (NRC) to develop a conceptual model that could evaluate products or product categories that FDA regulates and provide information on the potential health consequences associated with them. As a result of that request, NRC formed the Committee on Ranking FDA Product Categories Based on Health Consequences.

Difficult decisions are common for the Food and Drug Administration (FDA). Whether it is allocating scarce resources, deciding how to mitigate newly found risks, or deciding what investments in human capital, facilities, data, or analytic methods would be most useful, decision-makers in the FDA often need to integrate data of varied quality, recognize uncertainties, and make trade-offs to arrive at a decision. Public-health and public-safety concerns must be balanced with the economic realities of budgets and the political constraints of imposing new regulations.

How a program is presented by the media and understood by the public is an important determinant of the acceptance and success of the program. Science and public preferences and perceptions must be considered if one is to understand the potential outcomes of different decision options. To inform the decision-making process, data of differing degrees of quality and robustness must be used and sometimes fed through an array of models of varied sophistication. Expert opinion must be used to interpret the relevance of available data and to solve problems on which available data are weak or nonexistent. Immovable deadlines can thwart uncompromising reliance on the most thorough analysis based on detailed quantitative data for a given decision.

To succeed in such an environment, FDA needs a framework within which alternatives can be defined and evaluated systematically. Although it is beyond the scope of the present study to provide a comprehensive decision-making procedure for FDA, the committee proposes a general framework for thinking about and characterizing the human-health dimensions of FDA decisions. Health consequences are only a subset of the large array of factors that must be considered for any given problem. However, they constitute a reasonable place to start the process of developing a decision framework inasmuch as such factors loom large in most FDA decisions and substantial work has already been done on methods for estimating the human-health consequences associated with various risks, hazards, and decisions.

The framework offered here provides a common language for describing potential public-health consequences of decisions, is designed to have wide applicability among all FDA centers, and draws extensively on the well-vetted risk literature to define the relevant health dimensions for FDA decision-making.

This chapter first provides a brief description of the proposed framework and the risk and decision contexts that influenced the committee’s approach. Next, the basis and definition of the risk attributes that characterize the framework are provided, and then some approaches for estimating the outcomes of decisions using the risk attributes are described. The chapter concludes with a discussion of how the output of the framework can be used to support decision-making.

THE FRAMEWORK

The risk-characterization framework is designed to be as general as possible while providing consistent risk information in a way that can be used to support the wide variety of decisions that FDA faces. It is intended to supplement and augment other risk-based and risk-informed approaches that are in use and under development by FDA, not to be a replacement or a one-size-fits-all prescription for conducting all risk-informed decision-making.

Indeed, the committee recognizes that the public-health consequence factors highlighted in this framework will seldom be the only important considerations in the decision-making process, but they are almost always some of the key considerations. The U.S. Nuclear Regulatory Commission has also recognized that risks are not the only factors that must be taken into account in regulatory decision-making. It recently embraced the concept of risk-informed decision-making, which it defines as “the use of risk insights, along with other important information, to help in making decisions” (USNRC 2008, page 1-1). The committee’s framework focuses on risk information but also recognizes that other information will be relevant for most FDA decisions.

The process is straightforward and involves three steps:

Step 1. Identify and define the decision context: What decision options are being considered? What are the appropriate end points to evaluate and compare?

Step 2. Estimate or characterize the public-health consequences of each option by using the risk attributes that are described below. The values of the risk attributes should be summarized in a table to facilitate comparison of the options.

Step 3. Use the completed characterization as a way to compare decision options and to communicate their public-health consequences within the agency, to decision-makers, and to the public; use the comparison with other decision-relevant information to make informed decisions. Although the steps can be easily articulated, they involve thought and effort to complete.

The framework is not a cookbook and will require FDA to exercise judgment in how it is used.

The full report can be found here.

The policy of being too cautious is the greatest risk of all.

Jawaharlal Nehru

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Center for Public Integrity Smear 2

05/20/2011 03:57 PM |

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Marketplace on the Marketplace

05/20/2011 09:23 AM |

Insurers begin to adapt to health reform law

By Jennifer Collins Marketplace Morning Report, Friday, May 20, 2011

Listen to this Story

In order to pay for the coverage they'll have to provide for those with preexisting conditions, health insurance companies have been trying to raise premiums by double-digits. Come fall, they won't be able to without approval.

Jeremy Hobson: The federal government has announced new rules for health insurance companies as part of the Obama health care law. Starting September 1 companies will have to get approval if they want to raise premiums by more than 10 percent.

The insurers say that'll lead them to drop coverage in some areas, as Marketplace's Jennifer Collins reports.

Jennifer Collins: One of the big promises of health care reform is that everyone in the U.S. can get coverage, regardless of preexisting conditions.

Ethan Rome is with Health Care for America NOW! He says insurers anticipate paying for all those preexisting conditions.

Ethan Rome: And they've been jacking up rates at double-digit levels.

Starting this fall, if insurance companies want double-digit increases, they'll need permission to do it on individual or small group plans. Peter Pitts is with the Center for Medicine in the Public Interest.

Peter Pitts: Certain insurance companies will just decide not to do business in certain states and areas where they simply can't get the rates they need to stay in business.

Christopher Bowe is a health care analyst with Informa.

Bowe: My guess is they'll be flexible and look for ways to change their business model to stay profitable and become more efficient.

He says insurers have shown flexibility. The health insurance industry is on its way to a third year of record profits.

I'm Jennifer Collins for Marketplace.

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Center for Public Integrity Smears Mitch Daniels and Misrepresents The Facts

05/19/2011 12:50 PM |

My American Spectator article on how the  Center for Public Integrity  uses allegations, omissions and misstatements to attack Governor Mitch Daniels.  Note that CPI claims it is "thorough and objective."  

Political Hay

Smearing Mitch

By Robert M. Goldberg on 5.18.11 @ 6:07AM

The Center for Public Integrity (CPI) recently issued a report accusing Governor Mitch Daniels, who once was President of North American operations for Eli Lilly, of illegally marketing medicines that caused thousands of people to get sick and die.

It's a riveting story but it's not true. Instead, the report, written by Joanne Kenen and Rochelle Sharpe, is full of misstatements, inaccuracies, and outright falsehoods. If the Center for Public Integrity had any integrity it would yank the piece, apologize to Governor Daniels, and start asking who pushed to release such a sleazy ad hominem assault.

Here's the gist of the allegations:

In the decade that Daniels climbed the corporate ladder at Eli Lilly, the company was illegally marketing its leading osteoporosis drug, Evista, as well as its blockbuster antipsychotic, Zyprexa, putting tens of thousands of patients in harm's way. Lilly pleaded guilty to two criminal misdemeanors, paid more than $2.7 billion in fines and damages, settled more than 32,000 personal injury claims -- and copped to one of the largest state consumer protection cases involving a drug company in U.S. history, a review by iWatch News shows.

Eli Lilly engaged in illegal activity. But here's the gist of its unlawful actions: Eli Lilly was accused of providing doctors with medical information that Zyprexa could be used to treat agitation in people diagnosed with dementia and sleep disorders in people with schizophrenia. The government calls the distribution of such material without FDA approval a "false claim." A "false claim" is not a false statement. Rather, it's clinical data or published studies that confirm the effectiveness of new uses for existing medicines.

In other words, if Eli Lilly shared medical studies demonstrating that using a drug prevents cancer, it would be breaking the law.

In fact, that's what Lilly was fined $36 million for in 2005. The government had gone after it for telling doctors that Evista -- originally approved to reduce bone loss -- was also effective in preventing cancer in postmenopausal women. In 2007 the FDA approved Evista as a cancer preventive. During this time Medicare and Medicaid were paying for the off-label use of both Zyprexa and Evista.

Kenen and Sharpe also allege that under Daniels Lilly downplayed Zyprexa's side effects of significant weight gain and increases in blood sugar that could cause diabetes. In fact, the federal judge presiding over Zyprexa litigation noted "the original 1996 Zyprexa label listed the relevant adverse events; in 2003 the FDA… required a hyperglycemia and diabetes warning; the American Diabetes Association and other groups in 2003… issued a consensus statement on antipsychotic and weight gain and diabetes… a Dear Doctor Letter went out in March 2004. "

Further, since 1999 the company has published hundreds of articles examining the association between Zyprexa, glucose levels, and obesity and including research intended to help predict weight gain. That's in addition to scores of other papers written by others.

Still Kenen and Sharpe want to link Daniels to thousands of Zyprexa-caused injuries and deaths. To dramatize their case, the authors introduce us to Ellen Liversidge, who states: "Eli Lilly killed my only son." Her son Rob, 39, died in 2002 after taking Zyprexa. "I think they are terrible. They hid the side effects of so many drugs."

In fact, as Liversidge notes in another interview, her son died because "the intensive care unit team did not have his blood-sugar level checked for signs of hyperglycemia."

Liversidge is a member and founder of two organizations with ties to Ann Blake Tracy, an advisor to the Scientology-backed Citizens Commission on Human Rights, and Dr. Peter Breggin, who over the years has claimed that treating mental illness with medicine is a form of abuse.

Breggin has been an "expert witness" in many of the lawsuits against Zyprexa.

And Breggin is also a featured blogger on the Huffington Post, whose founder, Arianna Huffington, is a CPI board member.

Huffington and Breggin share a particular animus against Eli Lilly and Daniels in particular.

Since 1998, Huffington has waged a war of words against Eli Lilly for promoting Prozac and Zyprexa. She alleged in 2002 that Daniels was behind an effort to protect vaccine makers from lawsuits from parents who claimed shots made by Lilly and others caused their children's autism because they contained thimerosal. In 2005 she launched the Huffington Post and featured several anti-vaccine and pseudoscience fearmongers as bloggers, including Andrew Wakefield, Jenny McCarthy, and of course, Peter Breggin.

Did either Breggin or Huffington suggest or contribute to CPI's report? The link between CPI and Huffington's campaign against Mitch Daniels bears more scrutiny than the baseless claims that the Indiana governor presided over an orgy of criminal behavior.

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What's the oppostite of Mission Creep?

05/19/2011 08:26 AM |

CDER no evil?

Via BioCentury ...

CDER seeks to limit scope of Avastin hearing

FDA's Center for Drug Evaluation and Research said it does not believe future studies of Avastin bevacizumab are within the scope of a hearing on FDA's proposed withdrawal of metastatic breast cancer from Avastin's label. In a letter from CDER to CBER Director Karen Midthun, who is presiding officer for the June 28-29 hearing, CDER said future studies are not relevant to the center's conclusion that currently available data have failed to confirm the safety and efficacy of Avastin for the indication. CDER argues in the letter that the topic of withdrawal should be considered separately from the topic of future clinical trials. Genentech Inc. said it is submitting a response to CDER's letter.

However, Midthun has already indicated that future trials are a topic for discussion at the hearing. If the FDA commissioner agrees data provide grounds for withdrawal, the hearing will consider whether Avastin's accelerated approval should be maintained while Genentech conducts a confirmatory trial, according to the hearing's Federal Register notice posted last week. On Monday, the Roche (SIX:ROG; OTCQX:RHHBY) unit indicated it would focus its argument on that question.

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Hunter/Gatherer

05/18/2011 08:37 AM |

Lead, follow ... or get out of the way.

From the pages of Health Policy News:

FDA Weighs Role of Social Media In Agency Communications

FDA is seeking social media advice for its own communications practices as it crafts a much-anticipated guidance to govern the drug industry's utilization of Web 2.0 tools, with the agency struggling with how much its outreach efforts should include new Internet-based applications. The agency is mulling whether to take a more active role in social media outlets to interact with the public on issues like recalls and enforcement actions, but a former FDA communications official said the agency needs to embrace new media now to fulfill its public health mandate and to set an example for the industries it regulates.

As more doctors turn to social media to communicate with patients and because it has proven to be a vital tool in drug crises, FDA is evaluating how much it should participate in this evolving platform, indicating that it is a "gray area" for the agency to have staff actively participating in tools like Facebook and Twitter, agency officials said May 6 during a Risk Communication Advisory Committee meeting.

Advisory committee members and FDA officials indicated that by, for example, following people on Twitter, the government would have more interaction with the public. Greg Busse of the drug center's safety and risk communications team, said the psychological power of such an action would allow the government to engage in dialogue with with public.

"Whether or not it will ever come to light, whether it will work that way, I'm not sure," he said.

FDA has several Twitter feeds based on different topic areas, but each feed only follows a handful of government agencies and health organizations. The agency does not retweet information from other users. While following indicates whose information FDA is monitoring, retweeting, or sharing other users' ideas, indicates interaction with others on the media platform.

FDA has also researched the diffusion of and feedback from its message on various topics, including the peanut butter and egg recalls, action taken against Four Loko caffeinated alcoholic beverages and issues surrounding genetically engineered salmon.

Peter Pitts, president of the Center for Medicine in the Public Interest, told FDA Week that FDA needs to take action in the social media realm because it is where people are now getting their information and it advances the agency's public health mission. Further, he said the agency has already collected enough information through public meetings and studies to advance its use.

"Social media isn't an option," said Pitts, a former associate commissioner for external relations at FDA. "Social media is for many Americans their exclusive pathway for health information."

While all channels of social media should be embraced by the agency, he said video should be prioritized. The way the agency handles these platforms could direct industry, he said. "The FDA could do wonders by leading by example," said Pitts, who is also a consultant to the advisory committee.

Committee members said the agency could build trust and reinforce its message through the social media tools. "I think part of the challenge is sort of being authoritative and also accessible and responsive," one committee member said. Committee members also noted the repetition that comes from social media has positives and negatives as the agency's message could be manipulated and quickly disseminated.

The limited available space to convey risk-benefit information and viral nature of a social media message has also caused concern among industry, which has been pushing for guidance for how it can use these new tools without running afoul to marketing regulations. In recent weeks, FDA announced a series of studies on the Internet intended to inform the guidance, which in turn is likely to delay the document that has missed two goals for issuance.

During the meeting, Elisabeth George, a vice president with Philips Healthcare, questioned the committee on industry's responsibilities. As directed by the agency, "if there is any off-label use that is being done with our products or if there is any misinformation with respect to safety and efficacy, we need to take action ," she said. But it is unclear how far regulators expect industry to go in policing the information, she said.

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Duty. Honor. Patient.

05/17/2011 09:03 AM |

To paraphrase Douglas MacArthur, “The patient, and the patient, and the patient.”

That’s my optimistic take-away from yesterday’s Patient-Centered Outcomes Research Institute (PCORI) Board of Governors meeting.

But, you know what they say about best intentions.

The session began on a less than auspicious note with a PowerPoint presentation from the PCORI-retained public relations firm on how to best develop the institute’s “brand.” Suffice it to say there was a lot of multitasking going on.  What’s next on this particular agenda?  A PCORI theme song?

Then it was time to get down to serious business. And the first was the announcement of Joe Selby as PCORI’s first executive director. (He is a member of the Institute of Medicine, where he has studied quality and effectiveness issues. Selby joins Team PCORI from Kaiser Permanente in Northern California where he was director of the research division and oversaw a team of over 50 investigators and 500 research staff working on more than 250 ongoing studies.)

After PCORI Chairman Eugene Washington made the announcement, Selby commented, “For those of you participating in this meeting via webcast, I’m the one who looks like a deer in the headlights.”

Good luck Joe. You’ll need it.

Various discussion items followed. Of particular interest was that of PCORI undertaking (led by the Program Development Committee) of a Landscape Review of comparative effectiveness research (CER) – and this generated much debate.  Most important (and bear with me for a minute on this) was whether or not, once completed, this mega lit search should be posted on the PCORI web site.  It was astutely pointed out that this should not be the case – as it would give a sort of implied official imprimatur to the listed studies.  Surprisingly and positively there was general agreement that this survey should not appear online.

There was then a general discussion on what the “legacy” of PCORI would be.  And while that might sound a little grandiose and, well, premature – it did focus the board on what unique research role the institute can play in advancing the public health from a patient-centric perspective.

No real answer.  But a good question and the best comment came from NIH Director Francis Collins who said that if PCORI was looking for a unique and non-duplicative research agenda, it would be “a null set.”

Public comment followed. Mine consisted of the following points:

PCORI should not forget about outcomes data. Perhaps the institute should lead the way in coordinating the many large data sets of outcomes data held by both Uncle Sam and private payers.  The use of outcomes data needs to go beyond (well beyond) well-intentioned (but relatively small) CMS pilot projects.  The United Kingdom has such a nationwide system – but hasn’t been particularly creative or aggressive in using it.  PCORI should take the lead.  After all, what’s more patient-centered than real world outcomes data?

PCORI should create a program on educating patients, physicians and payers on the use and importance of molecular diagnostics.  After all, what’s more patient-centric than early diagnosis and advancing the “four rights” of the right medicine in the right dose to the right patient at the right time?

PCORI should help to advance the nascent science of adaptive clinical trials by creating and creating a home for www.adaptiveclinicaltrials.gov. After all, what’s more patient-centric than adaptive clinical trial information?

PCORI should stay as far away as possible from discussions of CER as a method for cost controls – as this is a slippery slope to price controls.  And price controls equal choice controls. Moreover, PCORI is officially tasked not to pursue comparative effectiveness but comparative clinical effectiveness. Comparative means which treatment (or healthcare technology if you prefer) is “better” (subjective) versus data on real world clinical outcomes. To put it bluntly, “comparative” is subjective. “Clinical” is outcomes-driven. It’s important to remember both the letter and the spirit of the stature.

(In fact, Francis Collins warned the board to “beware of the tension between CER and personalized medicine.)

PCORI should be careful in creating a databank of CER studies because (and particularly when you consider programs such as CATIE and ALLHAT) garbage in, garbage out.

PCORI should beware of information sharing via academic detailing. (Note:  20% of the PCORI budget is ear-marked to AHRQ for “information dissemination.) ‘Nuff said.

PCORI should (indeed must!) define “patient-centered” as care first and cost second – otherwise the “PC” in its acronym will only mean “politically correct.”

Next up was the report of the Methodology Committee and the centerpiece of this portion of the program was a working definition of “patient-centered outcomes research” (PCOR).  (Note: the word of the day was “iterative.") Here is the committee’s first draft effort

“Patient-Centered Outcomes Research helps people make informed decisions and allows their voice to be heard in assessing the value of healthcare options.  Given my personal characteristics, condition and preferences, what should I expect will happen to me?  What are my options and what are the benefits and harms of those options?  And what can I do to improve the outcomes that are most important to me?

Nice.  These “four questions of PCOR” should be widely shared and discussed.  If PCORI is looking ahead towards its “legacy,” this is a good place to start.

At the end of the meeting, one of the board members came up to me and said, “I don’t think you understand what PCORI is about.” She was confused that I had brought up the issue of cost controls in my remarks. “Don’t you know what we are, by statute, not allowed to take costs into consideration in our work?”

 I told her that I understood very well – but that, well, you know what they say about good intentions.

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Social Media, Pharma, and the Theatre of the Absurd

05/16/2011 08:16 AM |

Maybe they should call him Tom “Godot” Abrams.

Maybe not.  DDMAC continues to get slammed for not issuing the social media guidance it most recently promised to “try” to get out by the end of first quarter 2011.  While, on the one hand, one shouldn’t raise expectations (even by “trying”), DDMAC guidances (be they draft or otherwise) are a Trojan Horse.

The Bauhaus Boys said it best.  “Less is More,” opined the great Walter Gropius. “But” amended Mies van der Rohe, “More tastes better.”

Both are relevant to the issue of DDMAC and social media.  On the one hand, less (at least in theory) allows regulated industry to make its own rules, to find its own way. More, on the other hand, is what pharma seems to want. And, to be fair, predictability is always better than ambiguity when it comes to FDA regulations. Alas, that is not always possible – and expecting it (like Waiting for Godot) makes for absurdist theatre.

Here’s an article from the current edition of Ad Age that can be pretty well summed up in this quote from Samuel Beckett:

What do I know of man's destiny? I could tell you more about radishes.

FDA Guidelines Set for '10 Still Nowhere to Be Seen

Pharma Companies Still Waiting for Social-Media Guidance, but a New 60-Day Public-Comment Period Was Just Opened

Still waiting on those Food and Drug Administration pharmaceutical guidelines for social media and online advertising? Don't hold your breath.

The FDA has opened a 60-day public-comment period to study the impact of online consumer advertising for prescription drugs, further delaying the implementation of new rules for internet and social-media marketing -- rules that had been expected for months now.

The continuing delay is bad news for the industry, which is beset by stagnant new product pipelines and the patent expiration in the next 18 months of several blockbusters that account for more than $51 billion in annual sales, including Pfizer's Lipitor, the world's best-selling prescription medication. Big Pharma has looked to goose profits in several ways, including lowering ad spending with cheaper marketing platforms such as branded websites and social media.

Digital spending is on the rise -- eMarketer estimated that health-care and pharma companies spent $1.03 billion on internet ads last year, up 13.9% from 2009 -- but drug makers are inhibited from doing more by a lack of guidance for social media.

In a notice in the Federal Register, the FDA said it would conduct three concurrent studies in order to assess how current advertising rules governing print, radio and TV ads will apply to social media. Specifically, how do drug companies portray accurate and complete "fair balance" -- the risk and benefit information -- in a Facebook post or a 140-character tweet?

Though these studies and this new comment period that ends June 27 are separate from the agency's November 2009 hearing and public comment period on social media, the FDA said in its notice that the new study "will complement qualitative research we plan to conduct on issues surrounding social media."

Translation? Those social-media guidelines the FDA said it would deliver in 2010, and then put off until the first quarter of 2011, and are still nowhere to be seen six weeks into the second quarter. And they are still a long way off.

"This [new study] is completely different and it's completely irrelevant. This is just the FDA continuing to try to solicit input on what elements of advertising influence people in different ways," said Peter Pitts, former FDA associate commissioner and now the president of the Center for Medicine in the Public Interest. "What it's showing is just how behind the curve the agency really is."

The FDA admits the problem, saying in its notice in the Federal Register that, "The original regulations that presently determine FDA's position on DTC promotion were written at a time when the available media for DTC promotion were print and broadcast, and the primary audience was health care professionals. This dynamic is shifting, and evidence is needed to support guidance development."

There is, by and large, almost complete agreement in that assessment from all parties concerned. Now comes the waiting.

"To be candid, if you look at FDA historically, this is typical for them. FDA is loath to move quickly unless it involves product liability, like if someone is about to be poisoned by bad food," said longtime health-care agency executive Mike Guarini, the president of Connecticut-based Ryan TrueHealth. "Putting in social-media guidelines has become a joke. They don't know when they're going to do it, and neither does anybody else."

Asked if the delay is hurting business, Mr. Guarini said "Absolutely. No question about it. What I hear from clients and prospective clients is 'I want to do more in social media, but I don't know if it's good, bad or even legal.' The industry would just like some guidelines."

When that will be, however, remains to be seen. The FDA offered no timetable, saying only in its notice that "The series of studies described in this notice will provide data that, along with other input and considerations, will inform the development of future guidance."

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The Little Search Engine that (finally) Could

05/13/2011 08:58 AM |

Well -- maybe not so little.

In December 1, 2003, the Washington Post ran this story on the front page:

Google to drop rogue-pharmacy ads: Move is part of government effort vs. illegal drugs

Google, the popular search engine, will stop accepting advertising from unlicensed pharmacies that have used the Internet to sell millions of doses of narcotics and prescription drugs without medical supervision, company officials said.

The decision by Google Inc., based in Mountain View, Calif., comes as regulators and members of Congress shift their focus from the illicit pharmacies to the legitimate Web portals, credit card companies, shippers, and banks that facilitate the sales. Three congressional committees are looking into the issue.

Federal regulators, who have limited authority over online advertising, are examining how they can prod the search engines and other businesses to deal only with legitimate pharmacies.

 "We're literally placing calls to the search engines trying to get a meeting going," said Peter Pitts, the FDA's associate commissioner for external affairs. "You can't blame them for accepting commerce. But they really haven't understood the consequences."

Nearly eight years later, it seems those consequences are somewhat better understood. Today this story hit the pages of the New York Times:

U.S. Inquiry of Google on Drug Ads

Federal regulators are investigating Google on suspicion of illegally displaying ads for online pharmacies that are operating outside the law, government officials said Thursday.

Google has set aside $500 million to pay for a potential settlement, according to a Securities and Exchange Commission filing the company made on Tuesday. It said the money was for the “potential resolution of an investigation by the United States Department of Justice into the use of Google advertising by certain advertisers,” but gave no details.

In the last year, Google has made significant changes to its policies for accepting pharmaceutical ads, most recently in January. But Michael Zwibelman, litigation counsel for Google, has described it as “an ongoing, escalating cat-and-mouse game.”

In February 2010, Google changed its AdWords policy to accept ads only from pharmacies certified by the National Association Boards of Pharmacy in the United States or the Canadian International Pharmacy Association.

Better late than never.

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