FDA: HELP is on the way

04/14/2009 01:51 PM |

David Dorsey, who left the FDA on detail in January 2001 to the Senate Health, Education, Labor, and Pensions (HELP) Committee, is returning to the agency as a senior advisor to Principal Deputy and Acting FDA Commissioner Joshua Sharfstein. Dorsey’s portfolio includes the Office of Legislative Affairs.

"One of his major tasks will be to bridge the development of policy in the Centers and the Office of Policy and our legislative work through the Office of Legislative Affairs," Sharfstein wrote in an April 13 memo to senior staff.

The good news is the Dorsey (who previously serviced in the Office of the Chief Counsel) has significant expertise in the often-neglected areas of food labeling and dietary supplements.  He also has worked on medical devices and tobacco. 

One big difference Mr. Dorsey will find is that, today, there is no one remaining at FDA with any knowledge or expertise in the area of tobacco regulation.  If the agency receives Congressional authority to deal with tobacco (which now seems likely) it seems plausible that Dorsey could find himself leading the team.

Inquiring minds what to know -- What was the role of FDA Commissioner-designate Peggy Hamburg in the Dorsey appointment?  Considering the importance of position, one hopes she signed off on it.

Welcome back, David Dorsey.  
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The Incredible Shrinking Healthcare System

04/14/2009 01:48 PM |

Maybe it's being in Israel and reading too much from right to left but I get the sense that the infatuation with health IT will not make up for what appears to be an erosion in the actual treatment of real people...

For instance...

Minnesotans to receive access to a virtual clinic
April 13, 2009 | Molly Merrill, Associate Editor

ST. PAUL, MN – Minnesotans will soon have access to a virtual clinic, thanks to a partnership between Blue Cross and Blue Shield of Minnesota and American Well.

America Well's Online Care will provide Minnesotans with live interactions with physicians and other medical care providers. The virtual clinics at the worksite will emphasize treatment for common illnesses, monitor care for patients with chronic illnesses and offer preventive and wellness care.

Meanwhile....

Plan to close Northeastern Hospital stirs anger
By Josh Goldstein
Philadephia Inquirer Staff Writer

After 37 years at Northeastern Hospital, mostly in its bustling emergency room, Beverly Soska jokes that she knows many patients so well, she can diagnose them without asking a question.

Now the 67-year-old nurse who grew up near the hospital is worried about how her patients will fare if the Temple University Health System sticks to its plan to close the hospital in the city's Port Richmond section by July 1.

Northeastern is the dominant community hospital between Frankford to the north and Temple University Hospital to the west. It delivers 1,800 babies and treats about 50,000 patients in its emergency room each year, making it the ninth-busiest adult ER in the five-county area, state records show."

Oh well... If they are sick or pregnant or critically ill, they can just log in or visit a chat room....

Then there is this...

'Health Informatics Specialists' Play Key Role in Health IT Ramp-Up
Monday, April 13, 2009

Demand for "health informatics specialists" who have expertise in medical records, insurance claims, clinical care and computer programming is rapidly increasing as health care providers look to utilize the $19 billion in stimulus funding directed at implementing and expanding electronic health records, the New York Times reports.

These specialists usually start their career or education in computer programming or as health care professionals, and later earn a degree in health informatics and take midlevel or senior jobs at a hospital, doctor's office, insurance company, drug firm or other organization working with health care data.

William Hersh, chair of the Department of Medical Informatics and Clinical Epidemiology at Oregon Health and Science University, said, "The health IT people run the servers and install software, but the informatics people are the leaders, who interpret and analyze information and work with the clinical staff."

All of which is great if you are an Oracle server down for a day... But if you are a cancer survivor...well, at least you will have an electronic medical record, but not much else...

"In the United States, about 6.5 million cancer survivors are 65 years or older. Approximately 43% of these seniors survive more than 10 years, and approximately 17% survive more than 20 years from the time of their initial diagnosis, as reported in a December 2008 supplement to Cancer, "Aging in the Context of Cancer Prevention and Control."

Additionally, a shortage of oncologists creates the classic example of demand exceeding supply.

The American Society of Clinical Oncology (ASCO) predicts that by 2020, demand for oncology services will significantly outpace the supply of oncologists available to provide patient care. Driven principally by the aging population and an increasing number of cancer survivors, demand for oncology services will increase by 48% by 2020. The number of oncologists is expected to grow by only 14% in that same per-iod. This translates into a shortage of as many as 4,080 oncologists—roughly one-third of the 2005 supply."

Of the course the response is to dump more of the responsibility on primary care docs... but does anyone remember what is happening to the ranks of these medical foot soldiers ...

But those docs who try to practice quality medicine outside guidelines designed to keep care within deeply discounted limits wind up quitting or going elsewhere... And there is already a shortage of physicians to meet an aging population who are also chronically "ill" with cancer ...

And as for the lofty goal of providing integrated and preventive disease management at the primary care level there is this ...

Two-Thirds Of Primary Care Physicians Can't Get Mental Health Services For Patients

Shortages Of Mental Health Providers, Health Plan Barriers, And Lack Of Or Inadequate Coverage Cited As RoadblocksTo Mental Health Care

Bethesda, MD -- About two-thirds of U.S. primary care physicians reported in 2004-05 that they couldn't get outpatient mental health services for their patients -- a rate that was at least twice as high as for other services, according to a national study funded by the Commonwealth Fund published today as a Web Exclusive in the journal Health Affairs. Click Here to Read the Article

Conducted by Peter J. Cunningham, Ph.D., a senior fellow at the Center for Studying Health System Change (HSC), the study found that more than half of the primary care physicians reporting problems getting mental health services for their patients cited lack of or inadequate insurance coverage, health plan barriers, and shortages of mental health providers as "very important" reasons their patients couldn't get care.

Meanwhile the $700 billion "reserved" by Obama is to pay for people who already have access to health care and assumes that doctors and hospitals will take a 25 percent cut in reimbursement. It also assumes a decline in the introduction of new technologies and a more selective use of "high" cost services. Like psychiatric and cancer care.

In any event, there are fewer doctors across the board and more new technologies waiting in the wings. Investing in health IT will allow us to, perhaps, monitor the steady decline in health status and the cost of lost lives and prosperity as medical innovation is squandered. In the virtual world we are creating we all simply email our illness in. The doctor will "see" you but never touch or treat you in the new medical order. That's prevention for you.
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The New SILK Road

04/13/2009 11:29 AM |

One in 10 people over 65 – or 5.6 million Americans – will have Alzheimer’s Disease by 2010. Without interventional therapy, the number of cases is expected to rise to 13.5 million by 2050. As a recent CMPI study found, if we delay onset of Alzheimer's by 5 years it would be worth nearly $2 trillion to the United States.

For this sobering American pharmaco-economic data, have a look at the CMPI report, “Alzheimer’s Disease and Cost-effectiveness Analyses: Ensuring Good Value for Money? 

Click Here to Read the Report on Alzheimer's

Currently one of the biggest hurdles providers and payers face when deciding which treatment for Alzheimer’s disease to prescribe and pay for is efficacy.  Now the public health community may have a new tool. Scientists at Washington University have developed a test to quickly assess how effective a drug is at treating Alzheimer's disease.

Until now, determining whether a drug is working has meant measuring a patient's mental functioning over a long period of time. The new measurement tool -- called stable isotope-lined kinetics (SILK) -- takes just 36 hours.

Researchers recently developed the test to find whether an Alzheimer's drug given to healthy volunteers could reduce production of a substance known as amyloid beta. Called A-beta for short, the substance is a normal byproduct of human metabolism that builds up to unhealthy levels and forms plaques in the brains of Alzheimer's patients. Scientists believe it is this buildup of plaque tangles that causes the disease's characteristic mental deterioration.

The drug currently being tested is made by Eli Lilly and is in the third phase of clinical trials. Using SILK, researchers found the drug reduced the production of the troublesome A-beta.

Smooth as SILK?  Perhaps.  But certainly an important step forward in personalized, 21st century comparative effectiveness.  A step towards achieving the four rights – the right medicine for the right patient in the right dose at the right time.

The study was released today in the online version of Annals of Neurology. The study was funded through an Eli Lilly grant.
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What Would Hubert Say?

04/10/2009 12:29 PM |

A presidential executive order will establish a Department of Health and Human Services Office of Health Reform that will coordinate "closely" with the White House health reform office led by Nancy-Ann DeParle,

The executive order doesn’t not name the head of the new office, but cognoscenti point to Jeanne Lambrew who was originally recruited to serve as Daschle's deputy in the White House.  Since Tom’s tax troubles, she has been parked at HHS in an undefined role.

It is likely that Ms. Lambrew will act coordinator between the White House and HHS on healthcare reform-related issues.

The order also officially establishes the White House reform office. According to the executive order, the principle functions of the White House Office of Health Reform are to lead and coordinate development of the administration's policy development across executive departments and agencies, including the Domestic Policy Council, National Economic Council, Council of Economic Advisors, Office of Management and Budget, HHS and Office of Personnel Management.

The office will integrate the White House policy agenda across the federal government and coordinate public outreach to gather input from the public, from demonstration and pilot projects, and from public-private partnerships on priorities for policy measures.

We anxiously await the manner and methods this office will use to “gather input from the public” and how they chose who those publics are.

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David vs. Goliath

04/09/2009 12:27 PM |

Who’d a thunk it – the pharmaceutical industry recognizing that a well-funded, robust FDA is actually in their best interest?  Well, credit AstraZeneca chief executive David Brennan, who also happens to be the new chairman of PhRMA.

According to Brennan, a “strong, well-functioning” Food and Drug Administration is needed “but an understaffed and under-funded FDA is an agency in crisis.”  And, further, “we’re working hard for increased appropriations to the FDA so that it is recognized as a watchdog with a full set of teeth.”

Bravo.

Not only is this important for obvious public health reasons, but it’s also a crucial move by an industry in need of image repair – because as goes the public’s view of the FDA so too goes the Vioxx Populi.

Brennan also focused on a key point, so crucial to us all but so often ignored in the healthcare reform debate – the importance of innovation and, particularly, incremental innovation.

Speaking directly to President Obama’s call to “cure cancer,” Brennan said that “contrary to the Hollywood-like scenarios, our battle with cancer isn’t so much about spectacular breakthroughs as it is about steady, incremental progress.” However for that to continue “requires policies that are more conducive to the medical innovation that is the genesis and cornerstone of our industry…we need an environment that includes strong, well-defined intellectual property rights.”

David vs. Goliath indeed.

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The Soros Storm Troopers

04/08/2009 04:40 PM |

From the Policymed blog about David Rothman, the colleague of David Blumenthal the new health IT czar for President Obama and director of the Soros funded Institute for Medicine as Profession which believes that it's ok for medical journals to receive advertising revenue from medical device firms, biotech and drug companies but believes these industry should provide no financial support for educational or research activity even as government payors, health plans and left wing think tanks are free to do so.

The next target on IMAP's radar screen: patient advocacy groups, many of which receive all or nearly all of their funding from the drug, biotechnology or medical device companies. "We're going to address these patient advocacy groups, some of which are grass roots and some of which are astroturf," Rothman said.

Patient Advocacy groups need to be alerted that this very effective strategy as seen with Academic Medical Centers (Brennan paper 2006, followed by AAMC Taskforce 2008, followed by major reforms 2009), and now Medical Specialty Societies is a model that is working for IMAP.  This will be used against them.

They want to cause shame for doing the right thing (working with industry to develop new products that saves lives) even if it costs more in the short run. 

This Strategy should be exposed for what it really is, short sighted contempt.    Medical Societies, Academic Medical Centers and Patient Groups need to stand up against this bullying tactic; otherwise as a society we will all suffer the consequences of a lost medical research and education base.

Tom Sullivan is too kind.  This is  intellectual fascist.  Rothman represents a point of view that is toxic to the public health, that all "science" must be cleansed of the biases and viewpoints he and his fascist friends regard as the absoute truth.   The Jerry Avorns, Marcia Angells, Rothmans, etc inevitably endorse any conclusions that fit their ideology and refuse to subject their assertions to the scientific method.   ( It is the very reason that the comparative effectiveness crowd relies on a rigged approach to evaluation:  selecting only randomized trials with exclusion criteria that fail to control for variation in treatment effect and using meta-analyses to reach conclusions instead of generating hypothesis so as to reinforce the initial weakness of underpowered randomized trials.   All conclusions will show no difference in benefit among competing therapies... )

To assert that patient groups are somehow "fake" because they receive industry funding raises the question of who made Rothman and George Soros the gold standard of probity?  The ultimate measure of any individual or organization is the merit of their position, the contribution of their effort.   Does receipt of money from a currency wrecker, who has spent money to weaken the state of Israel (Soros), who himself invests billions in biotech and drug companies, qualify for knighthood compared to receiving support from companies that commercialize medical knowledge, invest in scientific research, give away billions in free medicines.  Soros -- and by extension -- Rothman and Blumenthal have profited from the profits of drug companies... 

If Rothman succeeds in his campaign of intimidation it will not "purify" medicine and thereby improve the quality of care.  There is no evidence of this cause and effect.  On the contrary there is no scientific evidence to support this assertion.  Meanwhile other countries and health systems are increasing the amount of collaboration with direct subsidies, increase patent opportunities, etc in order to promote innovation and retain scientific talent.

Rothman and his ilk are angy elites who should be shunned and attacked by the patient groups.  Once the patient groups are silenced then advocacy for faster cures will die.  What will happen next is fairly obvious.  Soros, who stood by without feeling as Nazis confiscated the property of Jews, has picked his associates well. 

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When "Cost" means "Co-Pay"

04/08/2009 12:40 PM |

A new research study from health-information company Wolters Kluwer Health reports that in the fourth quarter of 2008, U.S. patients failed to fill 6.8% of on-patent prescriptions, a 22% increase from the first quarter of 2007. Patients also abandoned prescriptions for generic drugs at a higher rate, failing to fill 4.1% of generic prescriptions. Why?  Because of “cost.”

What does “cost” mean?  Does it mean the AWP of a medicine?  Not for the 85% of Americans who have health insurance.  For them “cost” means “co-pay."

According to a story in today’s Wall Street Journal, “Higher co-payments required under health-insurance plans and other plan features helped boost the number of patients unwilling to pay for their prescriptions, according to the research.”

Not surprising.  Daniel M. Hartung, of Oregon Health & Science University, and his colleagues analyzed the effect of small co-payments -- $2 for generic and $3 for brand-name -- for prescription drugs introduced for Oregon Medicaid enrollees in 2003. The co-pay fees weren't required for patients who were unable to pay. The researchers examined pharmacy claims data on about 117,000 Medicare enrollees with depression, schizophrenia, respiratory disease, cardiovascular disease and diabetes. The patients' overall use of prescription drugs decreased by about 17 percent after introduction of the co-pay policy.

Why higher co-pays?   Because insurance companies don’t want patients to fill prescriptions for on-patent medicines. The Journal writes that “… insurers are flexing their muscle and rejecting coverage for more prescriptions. Health plans denied 10.8% of brand-name prescriptions in the 2008 fourth quarter, a 21% increase from the first quarter in 2007.

Cause and effect.

And it’s not because the medicine themselves are becoming more expensive. Consider this, from 1998 to 2003; insurance companies increased their premiums by an average of $104.62 per person. During that same time period prescription-drug costs increased by $22.48.

Are the majority of Americans with private health insurance spending more for drugs? Yes — because their insurance companies are paying less. In 2000, people under 65 with private health insurance paid 37.2 percent of the cost of their prescription drugs costs out of their own pockets. (Not surprisingly, this leads many Americans to believe that their increased out-of-pocket expenses are because of higher drug costs.) The truth is that the growth in prescription-drug co-payments outpaced the growth rate of prescription drug prices four to one.

Good for payers.  Bad for everyone else – including employers.

In June 2007, Gray Lady scribe Milt Freudenheim reported on a new study by the Integrated Benefits Institute that shows, "Employers that shift too much of the cost of drugs to workers in their company health plans could wind up losing more than they save, through absenteeism and lost productivity, according to a study by health policy researchers."

"Among the 17 employers in the study, conducted by the nonprofit Integrated Benefits Institute, more than half the workers with rheumatoid arthritis were not taking their drugs — in many cases because they considered the out-of-pocket co-payments too high.

As a result, the institute’s study found, the employers incurred $17.2 million in costs from lost productivity, 26 percent more than the estimate of what they would have spent if the workers had taken their arthritis drugs."

The headline of that New York Times article was, "Health penny wise, medical pound foolish?

Indeed.

Okay -- once more with feeling -- patients (otherwise known as "people," aka "voters") need to be on the right medicines for their conditions. And when payers interpose themselves between doctor and patient, when prescribing decisions are made by accountants based on “cost-effectiveness” studies, health outcomes decline for the individual and costs go up for our health care system.

This is not healthcare reform.

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The View from Germany: Profiting from Sick Patients

04/08/2009 04:47 AM |

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The view from Germany: Paying for health care

04/07/2009 04:17 PM |

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Something to Passover

04/07/2009 02:41 PM |

Why blog when all you can do is comment on events that underscore why we are closer to single payer health care than ever before....

WASHINGTON, D.C. (April 7, 2009) - Democratic and Republican party leaders and political operatives will discuss their differing perspectives on the challenges and opportunities associated with the comprehensive reform of the U.S. healthcare system during a keynote panel, titled "The Challenges and Opportunities Surrounding Healthcare Reform,” taking place Wednesday, May 20 from 12:00 – 1:45 pm at the Georgia World Congress Center during the Keynote Luncheon at the 2009 BIO International Convention.  

Moderated by Susan Dentzer of The NewsHour with Jim Lehrer, the panel will include Senator Tom Daschle, Governor Howard Dean, Senator William H. Frist, M.D, and Karl Rove. 

"This panel provides an opportunity to discuss and debate the best options and opportunities for the new administration as they move toward their goal of restructuring our nation's health care system,” said James C. Greenwood, president and CEO, BIO.  "As the Obama Administration and Congress explore how to restructure the delivery of the nation's health care services, it is important that the biotech industry is involved in the debate.”

The panel will address the road to a new health care system in the United States, providing a preview to the debates expected to take place in Congress later this year.  Panel members bring with them a vast array of experience in government service, from Congress to the Governorship and Chief of Staff to former President George W. Bush.

Great...that's exactly what we need.   Spin from spinmeisters who will tell the assembled how to behave to get a "seat at the table."  And I am sure they are all doing it for free.  I hope BIO got a good deal on the car service at least...

And how does listening to the same stuff and talking points from the New America Foundation and Rahm Emanuel (at least as far as Daschle is concerned) going to insure that biotech is involved in the debate.  Last time around biotech met face to face with President Clinton and the health proposal still called for comparative effectiveness reviews as a condition for reimbursement and use.   Now it's a done deal and BIO is fine with it.....  Have you seen those principles about "patient-centered" health care anywhere in the FCCER mission.  Anyone?

I still think it is better to stand up for principles before getting a seat at the table....And it's a lot better to give politicians a piece of your mind than to have them lecture you about how to behave in The People's House...  It is still ours...
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DDMAC Goes Mental

04/07/2009 12:14 PM |

If you like comparative effectiveness you’re going to love mental modeling.

The April 3 Federal Register carries a notice about a new DDMAC study, “Mental Models Study of Health Care Providers’ Understanding of Prescription Drug Effectiveness.”

The complete Federal Register notice can be found here.

The notice states:

“The Federal Food, Drug, and Cosmetic Act (the act) requires that manufacturers, packers, and distributors (sponsors) who advertise prescription human and animal drugs, including biological products for humans, disclose in advertisements certain information about the advertised product’s uses and risks. By its nature, the presentation of this risk information is likely to evoke active trade-offs by consumers and physicians, i.e., comparisons with the perceived risks of not taking a treatment, and comparisons with the perceived benefits of taking a treatment. The FDA has an interest in fostering safe and proper use of prescription drugs, which is an activity that necessitates understanding of both risks and benefits. Thus, an indepth understanding of physicians’ processing of this information, their thinking on relevant topics, and their informational needs are central to this regulatory task.”

Stipulated. 

And, according to the FR notice, the path to knowledge lies through “mental modeling:

 “… a qualitative research method that compares a model of the decision making processes of a group or groups to a model of the same process developed from expert knowledge and experience. In this study, the decision models of health care providers concerning their understanding of drug product efficacy and how they communicate their understanding to their patients will be compared to a model derived from the knowledge and experience of experts who review product labeling for the purpose of ensuring that prescribers get the information they need to make optimal prescribing decisions. FDA will use telephone interviews to determine from the health care providers the factors that influence their understanding of drug product efficacy and how they communicate their understanding to their patients. Comparing expert and health care provider responses will allow for a richer understanding of decisions determining drug product efficacy from labeling and other sources and how this understanding is communicated to their patients.”

 Like benefit/efficacy claims:

“Research and guidance to sponsors on how to present benefit and efficacy information in prescription drug advertisements is limited. For example, ‘‘benefit claims,’’ broadly defined, appearing in advertisements are often presented in general language that does not inform patients of the likelihood of efficacy and are often simply variants of an ‘‘intended use’’ statement. In a study involving a content analysis of direct-to-consumer (DTC) advertising, the researchers classified the ‘‘promotional techniques’’ used in the advertisements. Emotional appeals were observed in 67 percent of the ads while vague and qualitative benefit terminology was found in 87 percent of the ads. Only 9 percent contained data. However, for risk information, half the advertisements used data to describe side-effects, typically with lists of side effects that generally occurred in frequently. Additional research is necessary to uncover important information about how consumers understand effectiveness information about prescription drug products from DTC advertisements. This particular understanding is crucial to the risk benefit tradeoff that patients must make with the consultation of a health care professional in order to achieve the best health outcomes. The qualitative information in this Mental Models phase of the research will provide a preliminary framework and help FDA craft subsequent quantitative studies.”

That’s nice but, mental modeling notwithstanding, shouldn’t DDMAC look first to the well-understood failure of both the brief summary and fair balance/adequate provision methods it currently uses?

According to the FDA’s 2002 study, 65 percent of doctors believed that the DTC ads their patients saw confused them about the relative risks and benefits of prescription drugs—and that is a problem. In a 1999 FDA study, 56 percent of patients who saw a DTC print ad said that they read the brief summary “not at all” or “a little.” In the 2002 study that number jumped to 73 percent—an increase of seventeen percentage points. During that same three-year span, those saying they read “almost all” or “all” fell from 26 percent to 16 percent— these ten percentage points are not decimal dust by any stretch of the imagination.

In the “decimal dust” category, consider this: In 1999, 3 percent said that they weren’t aware that the brief summary even existed. In 2002 that dropped a full decimal place to 0.3 percent. In other words, more people knew that the brief summary was there, but fewer people were reading it.

And what about the FDA’s physician labeling rule? Revised in January 2006 for the first time in more than 25 years, the new format requires that the prescription information for new and recently approved products meet specific graphical requirements and includes the reorganization of critical information so physicians can find the information they need quickly. Some of the most significant changes include: A new section called Highlights to provide immediate access to the most important prescribing information about benefits and risks; A Table of Contents for easy reference to detailed safety and efficacy information; The date of initial product approval, making it easier to determine how long a product has been on the market; A toll-free number and Internet reporting information for suspected adverse events to encourage more widespread reporting of suspected side effects; A key-facts section that prompts doctors on what they should tell patients.

The problem is that this new format is prospective.  Previously approved medicines do not need to rewrite their PI in this format.

Something to think about.

Rather than mental modeling, perhaps the FDA should spend some of its precious time and resources developing a PI detailing tool to teach physicians about how to use the label as a potent patient conversation guide?

Sounds like a good project for the agency’s forthcoming “Safe Use of Drugs” initiative.

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Let's get this Part D started!

04/06/2009 05:55 PM |

Here's your Medicare reimbursement joke for today:

A Florida couple, both well into their 70s, go to a sex therapist's office.

The doctor asks, "What can I do for you?"

The man says, "Will you watch us have sexual intercourse?"

The doctor raises both eyebrows, but he is so amazed that such an  elderly couple is asking for sexual advice that he agrees.

When the couple finishes, the doctor says, "There's absolutely nothing wrong with the way you have intercourse."

He thanks them for coming, he wishes them good luck, he charges them $50 and he says good bye.

The next week, the same couple returns and asks the sex therapist to watch again. The sex therapist is a bit puzzled, but agrees.

This happens several weeks in a row.

The couple makes an appointment, has intercourse with no problems, pays the doctor, then leave.

Finally, after 3 months of this routine, the doctor says, "I'm sorry, but I have to ask. Just what are you trying to find out?"

The man says,

"We're not trying to find out anything.

She's widowed and lives with a daughter so we can't go to her house. I'm widowed and live with my son and family so we can't go to my house.

The Holiday Inn charges $98. The Hilton charges $139. We do it here for $50, and I get $43 back from Medicare.”

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Sponsored Links: Implications & Applications

04/06/2009 12:00 PM |

At just before 5pm last Friday  (April 3), the FDA posted 14 DDMAC warning letters.  They can all be found here:

 
Click Here to Read the Letters

First of all, kudos to the agency for posting them so swiftly.  The letters were all released on April 2 and posted on April 3.

DDMAC, timely?  What’s wrong with this picture?  Or, if you prefer, what’s right?

The next item to consider is the contents of the letters.  They all deal with the same topic, “sponsored” Google links.

DDMAC consistent?  What’s wrong with this picture?  Of, if you prefer …

Consistent because all of the letters not only deal with the same issue of sponsored links, but address them in more or less the same way.  Let’s take the letter to Bayer for example:

Here’s how the letter begins:

“The sponsored links cited in this letter are misleading because they make representations and/or suggestions about the efficacy of Levitra, YAZ, and Mirena, but fail to communicate any risk information associated with the use of these drugs.  In addition, the sponsored links for YAZ and Mirena inadequately communicate the drugs’ indications, and the sponsored links for Mirena overstate the efficacy of the drug.  Furthermore, all of the sponsored links fail to use the required established name.  Thus, the sponsored links misbrand the drugs in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA implementing regulations.  See 21 U.S.C. 352(a) & (n), 321(n); 21 CFR 201.10(g)(1), 202.1(b)(1), (e)(3)(i), (ii) & (e)(6)(i).”

 

While the particulars for each of the other 13 letters differ, the basic theme is the same, that the “sponsored links” are not in compliance because they are “misleading” – making “representations and/or suggestions” that DDMAC feels are out of compliance, and fail to present the appropriate risk information.

 

Now, as all you weathered FDA cowhands know – when it comes to DDMAC letters (and every other piece of FDA communication) – it’s very important to understand what’s in the letter as well as what is not.

 

These letters are about sponsored links.  What does that mean?  Sponsored links, as the DDMAC letters illustrate, are those links in the “sponsored” section of a web search (in the case of Google, these are the search results that appear on the upper right hand side of the page).  Never more than a few lines, they are teasers.  And, not to put too fine a point on it – they are paid for product marketing messages. They are advertisements.

 

The DDMAC letter to sanofis-aventis is particularly instructive on this point:

 

“Omission of Risk Information

 

Promotional materials, other than reminder pieces, which include the name of the drug product but do not include indications or other representations or suggestions relative to the drug product (see 21 CFR 200.200, 201.100(f), 202.1(e)(2)(i)), are required to disclose risk and other information about the drug.  Such materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the

materials.  The sponsored links present the following claims (emphasis in original):

 

* PLAVIX Medication Lowers Risks of Future Heart Attack or Stroke from PAD. See how prescription PLAVIX medication may help patients with recent heart attack, recent stroke, or established P.A.D. at PADfacts.com … “

 

So, DDMAC is making the point that sponsored links such as these are being considered as “reminder ads” gone wild.

 

Guidance?  What guidance?  DDMAC letters should help companies understand what “in compliance” means. These letters do not.  In fact, they make things more muddled.  After all, “sponsored links” are by no means a new phenomenon.

 

Podium policy via Warning Letters is not a replacement for clear and concise guidance.

 

Okay, so wither “guidance?” Consider some official agency direction that is already on the books:

 

Post-marketing Safety Reporting for Human Drug and Biological Products Including Vaccines

  Click Here to Read the Report

 

“Applicants should review any Internet sites sponsored by them for adverse experience information, but are not responsible for reviewing any Internet sites that are not sponsored by them.”

 

It’s not a leap of faith to understand the implications (and applications) of this relative to the concept of sponsored Google links.

 

For example, what about the concept of “clicking thorough” to full risk/benefit information?  Let’s look to the GSK letter for that one.  DDMAC writes:

 

“We note that these sponsored links contain a link to the products’ websites. However, this is insufficient to mitigate the misleading omission of risk information from these promotional materials.”

 

Now, here’s where it becomes less clear.  How will this impact regulatory perspectives on branded product websites?  What about third party websites that have been constructed with grants (unrestricted or otherwise) from interested parties?  What about links and websites for devices and diagnostics?

 

What about predictability? 

 

Well, that’s harder than it sounds because regulators love ambiguity. Ambiguity is power.  And that’s particularly true for DDMAC issues that quickly bump up against the First Amendment. That’s why interpretation of FDA actions is such a vibrant cottage industry. Industry, on the other hand, seeks clarity. They want bright lines. They want to know the rules. They want predictability. This may sound simple, but it has proven to be a fractious bureaucratic kulturkampf within the FDA.

 

My sources inside the agency (but outside of DDMAC) tell me they were caught by surprise by these new DDMAC letters.  What does this mean?  Does it expose the probability that this important social media issue was not discussed at higher levels?  You be the judge – but you can bet they will be now.  In fact, I wouldn’t be at all surprised to see this issue discussed at a sitting of the Risk Communications Advisory Committee.

 

(In fact, it should have been discussed before the letters were sent out in the first place – that’s what advisory committees are for. But that’s just my opinion.)

 

Here’s something that isn’t opinion -- sending out Warning Letters isn’t guidance – it’s punitive regulatory action.  It’s FDA acting tough without putting in the time and brainpower to explain how to address the perceived problem. That’s not what we need.  That doesn’t advance the pubic health.

 

Regulators change industry behavior by changing the rules of the game. But changing the minds of regulators, having them embrace bright lines rather than broad definitions, is a distinctly more challenging proposition, because changed minds must begin with change agents within the agency itself.

 

Predictability is power in pursuit of the public health.

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Conflicts of Dys-Interest

04/06/2009 06:04 AM |

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Dueling Peters

04/03/2009 09:31 AM |

On March 5th, at the National Disclosure Summit, I debated Peter Lurie (of Public Citizen fame) on the topic of transparency.  It was billed as “Dueling Peters,” and it lived up to its billing.

Here is a video link to our friendly but fractious (and often funny) forensic foray.

It’s worth watching.

On another note, this is proof positive that two people who hold strong opposing views can have a robust debate that is disputatious, substantial and respectful.

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Consensus on Healthcare Reform?

04/02/2009 01:28 PM |

Well, sort of.

The Center for Medicine in the Public Interest (the public policy institute home of drugwonks.com) is a member of the Health Policy Consensus Group, an affiliation of policy experts from major market-oriented think tanks and others who work together to advance patient-centered ideas for health reform.

That group has many ideas about how to move healthcare reform ahead in an expeditious and responsible way -- but our immediate concern is with many of the programs being both implemented and considered by the new administration.

First do no harm.

To that end we have issues the following statement:
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Obama and Biotech

04/01/2009 06:00 PM |

Creating the conditions for biomedical innovation is a lot cheaper than spending bailout money to keep car companies operating by lending them money, giving consumers loans to buy the cars they can't afford in the first place and then covering the warranties and car payments.

Biotech gets short shrift from Obama
His policies don't support entrepreneurial medical innovation.
By ROBERT GOLDBERG
Vice president, Center for Medicine in the Public Interest

President Barack Obama said last month that small businesses "are the heart of the American economy." He promised his administration would do everything it could to help entrepreneurs since they were the "core of America's story."

Yet, Obama's policies are threatening biotechnology – one of the most vibrant and important forms of small business our nation has ever produced.

Medical innovations have added wealth and health to our nation. From 1970-2000, increased longevity added approximately $3.2 trillion per year to national wealth, the equivalent of half of the average annual gross domestic product over the period.

According to a 2004 study by the Milken Institute, biopharmaceutical companies are responsible for creating over 2.7 million jobs across the United States. The industry was directly responsible for $63 billion in real output in 2003 and a total output of over $172 billion when its ripple effect is figured in across other sectors.

The president has increased federal funding for basic research and stem-cell science. With $20 billion a year in research funding, the National Institute of Health is important. But to translate discoveries into treatments will require more than the nearly $60 billion in money currently being invested by pharmaceutical, biotech and venture capital firms on cutting-edge treatments for cancer, Alzheimer's, AIDS, mental illness and heart disease.

That investment is (in real dollars) declining. Less than half of all public biotech firms have six months of cash left for research. For startups the situation is direr, even though the scientific promise of their investment is great.

Yet at every step of the way, President Obama supports policies that will stifle the entrepreneurship that he praises, and which are vital to actually producing real cures.

Obama supports de facto price controls that would allow the "reimportation" of prescription drugs. In essence, this is an effort to force every pharmaceutical and biotech company to sell drugs here at the controlled prices imposed in Canada and Europe.

Yet these are the same price controls that shut down medical innovation in those nations – companies sell their wares there for a small profit, but they don't risk the money to develop new lifesavers for those markets. If reimportation worked to force down prices here, it would also shut down the innovation Obama claims to favor.

Obama is establishing a comparative effectiveness council to slow down the introduction of new medical technologies. This entity would, like similar agencies in England and elsewhere, allows economists to compare old treatments with new ones and then tell doctors how much someone's life is worth – and whether it's worth saving – in order to save money.

The impact on innovation and patient well-being should be obvious. The UK's comparative effectiveness panel said new cancer pills were more effective than debilitating chemo treatments and extended life but still weren't worth paying for. No wonder the UK biotech industry issued a report blaming comparative effectiveness for killing not only people but the incentive for innovation.

Obama wants to apply comparative effectiveness to Medicare and eventually to every health plan. This would delay and ration the elderly's use of breakthrough drugs and ultimately let the government control what drugs and treatments everyone can take. In Europe, over the past 10 years, similar restrictions have caused the development of new drugs to stall. From 1993-97, Europe launched 81 breakthrough drugs; from 1998-2002, just 44. Meanwhile, U.S. drug launches jumped from 48 to 85.

Finally, it is disappointing that Obama made food safety, not medical progress, his number one concern in reforming the Food and Drug Administration. Indeed, Obama added money to the FDA's budget to inspect spinach but not to speed up the approval of breakthrough drugs for spinal cord injuries, multiple sclerosis and rare diseases. The agency has a program using 21st-century science – such as gene and stem cell-based tests – to determine if new medicines work. But Obama has refused to add money for that effort. You can score more political points sticking it to drug and biotech companies than standing shoulder to shoulder with dying patients.

Together, these policies are draining the life out of the biotechnology industry. The president is investing in "green" technologies to promote the environment. Yet, his health care policies will undermine private sector investment in medical innovations critical to solving public health problems related to the aging and growth of the world's population.

For all his rhetoric, thanks to his policies the medical discoveries the president supports will never be translated into economic prosperity or treatments that transform humanity.

Click Here to Read the Full Article

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April Fool

04/01/2009 05:15 PM |

That would be me -- caught in an April Fool's joke about a new FDA draft guidance on social media.  My request about this at FDA was, "huh?"

Sorry if I caused any marcomms gyrations.

(But it's still a good idea to replace ambiguity with some clarity in the social media space.)

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FDA Issues Warning on Social Diseases

04/01/2009 02:58 PM |

Well -- now that I have your attention:

FOR IMMEDIATE RELEASE

April 1, 2009

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

New FDA Draft Guidance Aims to Improve Health Information Obtained via “Social Media” Websites

The Food and Drug Administration today issued a draft guidance document designed to improve communications to consumers and health care practitioners about health conditions and medical products that they obtain on “social media” Websites such as Facebook, YouTube, Twitter and online bulletin boards. The guidance is the result of FDA research and policy development, and was influenced by the success of the recent social media based peanut recall program.

"We intend to do all we can under the law to make sure that the information conveyed by prescription drug promotion is as useful as possible," said acting FDA Commissioner, Dr. Joshua M. Sharfstein. "Our new regulatory guidance provides new direction to sponsors on how to provide higher-quality health information to the public via social media sites, based on recent evidence on what works and what doesn't. The evidence shows that social media promotions directed to consumers can play an especially important role in helping patients start a discussion about conditions that are often unrecognized and therefore undertreated, such as diabetes, high blood pressure, high cholesterol, depression, and obesity. And we think those discussions should reflect a better understanding of the key risks and benefits of a product. Without participation by pharmaceutical companies in those discussions, there is increased likelihood of false or dangerous information being promulgated throughout the Internet."

According to an FDA study, a majority of interactive agencies surveyed feel that social media product messages increase patient awareness and involvement, and improve compliance. That study also shows that social media-stimulated visits to a physician can help identify a previously undiagnosed condition. Importantly, of patients who visited their doctors because of an online discussion they participated in, 95% actually had the condition the drug treats. That percentage was even greater than that reported among patients who viewed DTC ads on TV.

The draft guidance provides (1) a simple method by which sponsors can insert a notice about reporting adverse events in their posts to social media sites, (2) “safe harbor” conditions that relieve manufacturers of responsibility for reporting adverse events they may hear about on social media sites, and (3) advice for manufacturers on the types of branded and unbranded communications that fall under the rules set forth in the guidance.

"Clear, evidence-based regulatory guidance will help FDA use its limited resources to police the marketplace as effectively as possible," said Sharfstein. "FDA will take action against sponsors whose ads violate the law by presenting false or misleading information to the public via social media sites. Our new draft guidance is intended to help responsible companies comply, for the benefit of the public health. If they don't, we now have an even stronger basis for pursuing enforcement actions."

More on this to be sure.
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Pyrrhic Lyric

04/01/2009 12:31 PM |

As you have surely seen, a group of the usual suspects, often referred to in the media as “a group of leading doctors and researchers” (WSJ) is calling on medical associations to forego funding from drug and device companies.

At the just-completed American College of Cardiology meeting, according to a report in today’s Wall Street Journal, “badge lanyards and program bags featured only the specialty medical group's logo and convention name.”

And healthcare in America is saved!

Maybe not.

According to ACC’s chief executive Jack Lewin, drug and device companies, “have zero impact on the content of any program here” He also said banning industry support could force a spike in registration fees, discouraging doctors from attending.

You can look it up under “Pyrrhic Victory.”

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