Son of Diagnostical Materialism

12/30/2008 01:38 PM |

Per yesterday’s blog, “Diagnostical Materialism,” have a look at the latest article in the New York Times’ “Evidence Gap” series, “Patient’s DNA May Be Signal to Tailor Medication.”

Here’s a paragraph to whet your appetite:

“Many policy experts are calling for more studies to compare the effectiveness of different treatments. One drawback is that such studies tend to be one size fits all, with the winning treatment recommended for everybody. Personalized medicine would go beyond that by determining which drug is best for which patient, rather than continuing to treat everyone the same in hopes of benefiting the fortunate few.”

A worthwhile read.
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I Can Get It For You Retail

12/30/2008 05:04 AM |

Hasn't the New York Times ever heard of retail health clinics?
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Diagnostical Materialism

12/29/2008 02:25 PM |

Molecular diagnostics are what make medicines personal. Diagnostics are how drugs can be made “safer” -- through “safe use.” They make the “four rights” (right medicine for the right patient in the right dose at the right time) possible.  And the four rights lead to lower costs through better outcomes.

Case in point:  Warfarin, the most widely used anti-coagulant medication in the world. Prescribed to over 2 million people a year to prevent blood clots, heart attacks and strokes, patients can display markedly different responses to the drug. Doses vary enormously between individuals; so achieving the correct dose is critical, as patients who receive too high a dose are at risk of severe bleeding, while those who receive too low a dose may remain at risk of life-threatening blood clots. Via molecular diagnostics specifically called out in the amended FDA label, physicians will prevent 85,000 serious bleeding events and 17,000 strokes annually – and that’s just in the United States. And this “safer use” is estimated to save $1.1 billion annually.  And that’s the mid-range.

But diagnostics are in trouble.  And that trouble comes in the form of skittish reimbursement and ambiguous regulation.

On the reimbursement front, many payers aren’t ready to accept the up front expense – even though the longer-term savings can be substantial.

Case in point:  Herceptin. Studies show that Her2 testing for breast cancer delivers savings that are 65x its cost.  For a very powerful presentation on the economics of the Her2 test and molecular diagnostics in general see here.

In short, reimbursement should be based on value rather than activity.  This is an essential (you should excuse the expression) paradigm shift. 

On the regulatory front clarity and predictability are required. FDA approved the molecular diagnostic for warfarin based on a broad range of published literature together with the results of a study, conducted by the manufacturer, on hundreds of DNA samples.  But guidance on diagnostic approvals are vague as is the pathway.  To reinforce the agency’s commitment to personalized medicine, the FDA should embrace ever-greater clarity and commitment to diagnostic tool review.  This should be a top priority of the agency’s Critical Path program.

Unless and until the reimbursement and regulatory issues are addressed, investment in developing these tools will languish, patients will needlessly suffer and our healthcare system will continue to be burdened by unnecessary costs.

If the popular culture clarion call is for “safer drugs,” then the path forward shouldn’t include beating up Big Pharma or reversing FDA preemption authority – it’s via molecular diagnostics. 

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Medical Home or Potemkin Village?

12/26/2008 01:52 PM |

“President Bush leaves office with a health care legacy in bricks and mortar: he has doubled federal financing for community health centers, enabling the creation or expansion of 1,297 clinics in medically underserved areas.”

Says who?  The New York Times.  (Ergo, it must be true.)  The article, “Expansion of Clinics Shapes a Bush Legacy.” All the news that’s fit to print?  Well almost.  It’s pretty amazing that the Gray Lady opted to leave out any mention of Part D in the President's legacy.  But maybe that article’s on the way.

But to give credit where credit is do, it’s a good article that raises some important questions -- one of the most important raised by House majority whip Representative James E. Clyburn (D, SC).  Mr. Clyburn makes the very important point that reducing the number of uninsured will be meaningless if the newly insured cannot find medical homes.

This is a key policy point for many reasons, not the least of which is the successful management of chronic disease.  Minus a warm and welcoming (and e-tized) medical home, we cannot seriously advance prevention initiatives (i.e., early detection) or improve our abysmal compliance/adherence rates. Minus a medical home we remain an acute care culture.  Minus a medical home, even community health centers are but Potemkin villages.

Last year over 80,000 Americans had a foot amputated because of undiagnosed and untreated diabetes. Hundreds of thousands of heart attacks and strokes, caused by undiagnosed or untreated high blood pressure and high cholesterol, cost the American health care system billions of dollars a year while the cost in terms of human suffering cannot even begin to be measured.

Lack of early detection?  Sure.  Lack of compliance/adherence?  Definitely. Lack of a medical home?  Shameful. 

When it comes to healthcare reform, we cannot leave patients home alone.

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FDA Reform by the Numbers

12/24/2008 03:40 PM |

When it comes to FDA reform, if you don't ask the right questions, you won't get the right answers.

It’s been widely reported this week that the FDA approved more “first-of-a-kind” drugs in 2008 (21) than it did in 2007 (18).  During that same period fewer “black box” warnings (both new and updated) were awarded in 2008 (46) than in 2007 (62).  What do these numbers mean?

To some (and you know who you are) they signal an agency that isn’t as concerned with safety as it was only twelve months earlier.  More drugs approved?  Fewer black boxes? And why, these same FDA watchers wonder, isn’t DDMAC sending out more warning and untitled letters to curb the abuses of pharmaceutical marketing – particularly of the off-label variety?

These are some of the questions they would ask.  The media-friendly questions.  The staff-prepared hearing questions.  The trial lawyer questions. The politics before public health questions.  The "tabloid medicine" questions. And they are the wrong questions.

For those who actually understand what’s going on there is a different set of queries altogether:  Why did the FDA miss review deadlines for at least 15 drugs?  Why are a growing number of complete response letters sounding more and more like the old-style not-approvable variety?  And why are more and more complete response letters requesting information that was never discussed during the review process or at advisory committee meetings?  Savvy pharmacenti also want to know what in Hell’s Bells is going on with “early safety” communications and signal-to-noise ratio issues.

But the big question those who know are asking is, Why is ambiguity trumping predictability in the regulatory process? This is the key issue that must be addressed by the new FDA Commissioner.  That’s the question.  The fear is Precautionary Principle creep.  If the FDA adopts the position of doing nothing until it knows everything -- that will send a chilling message to the pharmaceutical industry to dial back R&D unless the program looks like a sure thing.

And there are no “sure things” in pharmaceutical discovery and development.

Industry seeks clarity. They want bright lines. They want to know the rules. They want predictability. This may sound simple and fair, but inside the FDA it has proven to be a fractious bureaucratic kulturkampf.  “Change is not required,” as management guru W. Edwards Deming once said. “Survival is not mandatory.”  And that doesn’t mean change for show, for politics – it  means thoughtful, timely, strategic change that enhances the public health.  And that kind of change requires not walking on egg shells – but breaking them.  Andy von Eschenbach learned that the hard way.

Changing the minds of regulators to embrace bright lines rather than broad definitions is a challenging proposition -- because changed minds must begin with change agents. The new Commissioner must seek out and work with those career officials within the FDA who are smart, confident and gutsy enough to embrace new ways of doing business, who support bright lines over draft guidances, pragmatism over dogmatic doctrine.  And those people are there and are excited about the possibilities of an FDA that will lead rather than an agency that buffets from side-to-side based on gusting political winds.

FDA’s Critical Path initiative is a promising example of the agency’s desire to embrace change. Going forward, the agency’s stakeholders will be looking for other “surrogate markers” to gauge FDA’s willingness to continue the McClellan era’s aggressive determination to both protect and advance the public health.

Despite new draft guidances that attempt to draw bright lines, what is and is not “in compliance” remains more art than science. Industry is confused, and the public health is not served.  Predictability is power in pursuit of the public health. Predictability is the result of creative, forward-thinking leadership that rises above bureaucratic ambiguity.  Driving this philosophy won’t be easy for the new Commissioner -- because swimming against the tide of an entrenched bureaucracy never is. But if the Commissioner communicates this philosophy, leads by doing and empowers change agents within the FDA career staff, the tide will turn.

As Winston Churchill said, “Ease is relative to the experience of the doer.”

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Talk is Cheap..So Are Lives

12/24/2008 02:47 PM |

Another study showing that certain drugs used in combination when we are old don't always mix well. 

This on the heels of a NEJM study showing high and low responders among Plavix users based on genetics.

How long will it take HMOs to connect the dots, save lives and practice patient-centered medicine by using genetic testing on high risk populations?
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Healthcare Reform and Two Boxes of Thin Mints

12/23/2008 01:34 PM |

Interesting story in today’s New York Times on Tom Daschle’s call for “Healthcare House Parties.”

In typical New York Times fashion, the event they chose as an example was peopled mostly by Obama campaign volunteers (including one person who works at the NIH and another who is “active in women’s health advocacy”).  So not your typical slice of America. 

Nevertheless, some interesting tidbits.

For example, here’s what one party member had to say about a government-sponsored plan, “similar to Medicare,” that would compete with private insurance companies -- “A public insurance plan would not take anything away. It just adds another option.”

Options are good. But would a government plan compete fairly?  Or would it ultimately drive private plans out of business by adopting, what in the free market world would be referred to as, a loss-leader strategy?  And we all know what happens once that happens.  A government run one-payer system that puts cost before care.  Options are good.  Naïvité is not.

And what might such a system cost?  According to the Times story, “The Obama transition team did not ask people how a new health care system should be financed, but several people here said that individuals and businesses should have to pay a small health care tax — some preferred to call it a ‘contribution’ — so that everyone could be covered.”

That’s nice.  A contribution.  Like buying Girl Scout cookies.  Well, not quite.  Consider the facts:

In the United Kingdom, British citizens pay 11 to 12 percent of their weekly income to finance the country’s healthcare system. And in Canada about a fifth of taxes collected in Canada go toward funding the country’s health system.  That's a lot of Thin Mints -- more than many Americans are willing to swallow.

In a recent poll  of over a thousand 18 to 24 year-old Americans – the so-called “millennial” generation -- conducted by the Center for Medicine in the Public Interest (the public policy home of drugwonks.com), 62% said they would not support any reforms that could increase physician wait times or restrict access to new medical treatments. Nearly two-thirds said they would not support additional government interference in the doctor-patient decision-making process.

Precisely the result of government healthcare. 

Oh, and a majority (51 percent) were not in support of any health care reforms that could raise their personal tax burden.

The Times reports that, The Obama transition team asked for ‘particularly poignant stories to highlight the need for health care reform,’ and such stories were abundant at the round table here.”

But can we afford healthcare reform by anecdote?

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How About Rating Health Plans?

12/23/2008 01:59 AM |

Ok to rate doctors and hospitals, but why are HMOs so reluctant to be rated in terms of how patient-centered they are? 

Blue Cross, Zagat to rank doctors
But the ratings will be based on nonmedical factors, and some question insurance link

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Integration Now!

12/22/2008 10:29 PM |

Could you invent better timing for a new book on integrated cardiac safety?

Our friend Rick Turner (along with Todd Durham) has co-authored an important new study of new, more effective approaches for screening drugs for adverse cardiac effects, "Integrated Cardiac Safety."

This timely tome deals with drugs that are not indicated for cardiac diseases or conditions. It begins with an introduction to cardiac safety assessment and the biology of adverse drug interactions. Following sections on cardiac function and cardiac pathophysiology and disease, the authors guide readers through the assessment process during discovery, pre-approval (including QT/QTc trials), and postmarketing surveillance. The book concludes with chapters on medication errors and an examination of future trends in drug safety.

For more information on this publication and how to order your own copy, see here.

The perfect holiday gift for the pharmacovigilance geek in your family!
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NY Can't Fail Its Way to Budgetary Salvation

12/19/2008 02:57 PM |

Desperate times call for desperate measures -- and nowhere is this more evident than in Governor Patterson's proposed budget for New York.

But pennywise and pound-foolish doesn't help. And nowhere is this more true than when it comes to healthcare.

Specifically, the Governor's budget calls for the required use of step therapy for many medications. This means patients must "fail" their way to more expensive (generally on-patent) drugs. So, even if a physician wants her patient on (what in her expert medical judgment is) the best, most effective therapy -- the state demands multiple therapeutic failures via less expensive options first. This is a short-term fix with very expensive long-term repercussions when you consider that (nationally) 7% of our healthcare spend is on brand-name pharmaceuticals while in excess of 30% is on hospital care. When patients are forced to fail -- hospitalization often ensures. The budget wizards in Albany calculate this program would save the state $18.9 million in the next budget year. But the unintended consequence of increased hospitalization rates could be staggering. Step therapy? Bad idea.

Another codicil calls for required disclosure of payments by manufacturers to prescribers of over $50. There is no listed budgetary saving to the state. So why is it in the budget? We know why -- because too many of our elected representatives have a serious jones out for the pharmaceutical industry. So be it. But if disclosure is the order of the day than it should also be required of insurance companies that offer monetary spiffs to physicians for switching their patients to lower cost medicines and to lawyers who pay doctors to be "expert" witnesses. What's good for the goose is good for the gander -- but it doesn't save the state a nickel.

Along these same lines is another line item that requires the presenters of continuing medical education to disclose financial relationships with manufacturers. This is a contentious public policy issue -- but not a budgetary one. (For more on the CME issue, see "Battling the COI Polloi" here.) Savings to the citizens of New York State -- zero.

If the order of the day is austerity (and it is) then Albany needs to stay on point.
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FDA Transition Talk

12/18/2008 11:48 AM |

Playing FDA parlor games may be fun for some -- but reform of the U.S. Food and Drug Administration must be about serving the public health—not partisan political interests. That’s why I was honored when the Obama FDA transition team called and asked for my advice on how the incoming administration could make the agency a more robust and forward-looking regulatory instrument.

The transition team’s initial request was a memo, of no more than two pages, outlining key issues and offering general recommendations. Never have two pages seemed so inadequate. But I did my best.

My suggested areas of focus are

(1) A strong, science-based FDA

(2) The Reagan/Udall Foundation -- a Partnership of Unequals

(3) Clarity vs. Ambiguity

(4) Information Management

(5) Food Safety and Security

(6) Risk Communications

(7) The Drug Label and the "Safe Use" of Drugs

My complete memo to the transition team can be found here.

There are, obviously, many, many other important issues (a more thoughtful position on expanded access, United States-European Union regulatory harmonization, etc.) andI look forward to working with the transition team to ensure that the new commissioner can hit the ground running—in the right direction—with some early and important wins that will set the tone for a newly confident FDA. And kudos to the Obama transition team for reaching out to a wide variety of groups. That's the right way to get things done -- despite what some politicians and pundits may think.

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Spreading the Pain With Comparative Effectiveness

12/17/2008 08:30 PM |

Steve Pearson is quoted in today's New York Times as filling in the evidence gap prostate cancer care... Wow.

“Most policy makers think that, in general, we would want to do more national coverage decisions, partly because there’s a concern that the evidence review in most local regions isn’t very good,” said Dr. Steven D. Pearson. He is president of the Institute for Clinical and Economic Review, an organization partly financed by the insurance industry that is pushing for the use of evidence in medical decisions.

But that concern reflects an impatience with the views of others, particularly patients and physicians who would disagree with comparative effectiveness decisions that Pearson and his group would be entitled to produce under proposed comparative effectiveness legislation. His response to to a piece by Tom Philipson in health affairs about how comparative effectiveness analysis is, in fact, price controls is revealing:

"Surely an innovation that creates a near-cure for HIV should be valued more than a new combination pill of previously established drugs. It seems nonsensical that society would want to lavish rewards on innovators who produce equivocal or marginal gains and charge a steep price. The key is not to control prices but to incentivize investment in interventions that yield significant gains in effectiveness. When used rigorously and transparently, cost-effec-tiveness criteria can send the signal that the bestway to succeed as an innovator is to create interventions that are much more effective than previous alternatives. This is the signal that is missing from much of the U.S. healthcare system, where low-risk and marginally superior interventions are marketed to price insensitive physicians and patients.

I would completely reframe the authors’ argument by advocating that linking insurance coverage to cost-effectiveness might make patients feel a little worse off today but would
greatly benefit future patientswho will inherit a less bloated and wasteful health care system. That way, future patients will find a health care market dominated by focused, skilled innovators
who know that their greatest reward will come from producing interventions of greatly enhanced effectiveness at a reasonable cost. If, as a result, some of today’s venture capital chooses to flee elsewhere to seek easier returns, so be it. Let’s get the innovation we want."

Note how he concludes that government set criteria or criteria provided by the institute via government contracts can replace "price insensitive physicians and patients." Then and only then my friends will be the innovation "we" want. And if we make patients a little worse off in the process, oh well.
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Scherer's Case for Price Controls

12/17/2008 03:01 PM |

Here's how Fred Scherer explains how price controls won't discourage innovation:

In criticizing a paper, one of only dozens showing that price controls do discourage innovation (and he only has to look at the reality in Europe, UK, and elswhere, but ok, just pretend your Harvard generated model is the real world ) Scherer claims "that the drugs chosen for the authors' analysis are neither the most therapeutically innovative candidates nor those whose development is most likely to be discouraged by price controls."

Really. So Prof. Scherer knows which drugs -- years before they will be approved and used and then subsequently evaluated with tomorrow's genomic and epigenetic techniques, which drugs will be the most therapeutically innovative or discouraged.

Has he run a drug or biotech company? How about a venture capital fund? Last time I checked, the most therapeutically innovative candidates were also the most challenging to develop and required a higher burn rate and a higher rate of return. And where is that money going to come from? Did he factor comparative effectiveness delays and market restrictions into his model?

See the Health Affairs article here.


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All The Opinion That's Fit to Print

12/17/2008 02:13 PM |

When news articles (as opposed to op-eds) offer opinions, they are supposed to be between quotation marks.

When a reporter slips in his own opinion, it’s sloppy editing at best and inappropriate bias at worst. Consider this paragraph of unattributed reportage from today’s New York Times article, “F.D.A. Commissioner and Other Top Health Officials Plan to Step Down” --

“If Dr. Sharfstein or Dr. Nissen is chosen, the selection is likely to signal the end of an era at the agency in which the speed of the drug approval process often took priority over the certainty of a drug’s safety.”

FDA has put speed of approval over safety? Says who? The New York Times? If that’s the opinion of the editorial page, then they should say so. If this is Gardiner Harris’ opinion, he’s entitled to it – personally, but this isn't where it belongs. Not ever.

Also, what’s all this about “certainty of a drug’s safety.” Is the New York Times calling for a Precautionary Principle approach to drug regulation?
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Do you deny it, Mr. Darzi?

12/17/2008 12:51 PM |

Do I sense a growing social consensus around the concept of collaborative healthcare reform? I do.

And that’s a good thing – because real reform cannot happen otherwise. Top-down efforts don’t cut it. That’s a lesson we can learn from our transatlantic cousins. Consider “High Quality Care for All,” (aka, “the Darzi report”) -- the recently released NHS “next stage review” document. It calls for, as one of its “key steps,” “ A Coalition for Better Health, with a set of new voluntary agreements between the Government, private and third sector organisations on actions to improve health outcomes.”

Jolly good -- and something our new healthcare czar/HHS Secretary should consider.

(If you’re interested in reading where the NHS is going – or at least planning to, here’s a link to the complete Darzi Report.)

Among other things, this means all stakeholders must have a seat at the table. Yes, even industry. And this has particular resonance when it comes to FDA and the Critical Path initiative. What we need is a consensus (especially among members of Congress like Representative Rosa DeLauro) that the agency can and indeed must be both regulator and colleague -- and that collaboration on developing the tools for 21st century drug development and regulatory science are too important to remain mired in the treacle of politics and posturing.

But there’s a caveat – all too familiar to our friends at the NHS -- that of using the costs of sickness “as a means of turning benevolence to power.”

That last quote comes from Paul Starr’s “The Social Transformation of American Medicine,” and it’s worth quoting in its entirety:

“Whoever provides medical care or pays the cost of illness stands to gain the gratitude and good will of the sick and their families. The prospect of these good-will returns to the investment in healthcare creates a powerful motive for government and other institutions to intervene in the economics of medicine. Political leaders since Bismarck seeking to strengthen the state or to advance their own or their party’s interests have used insurance against the costs of sickness as a means of turning benevolence to power.”

In other words, healthcare reform must be about healthcare – and not politics. Easier said than done? Certainly. But a truth we must, er, hold self-evident.

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Healthcare "like in Europe?"

12/16/2008 12:48 PM |

Healthcare "like in Europe?" Bad idea.

According to new study (published in a five-paper special report on drug pricing in Health Affairs), imposing European-style price controls on prescription drugs in the United States would result in modest cost savings that would be more than offset by shortened life spans as the pace of drug innovation slows.

The report suggests that lowering insurance co-payments would be a better way of attacking the problem of rising prescription drug prices in the United States.

"We found policies that regulate the prices of drugs could result in modest savings for consumers, in the best cases on the order of $5,000 to $10,000 per person over a lifetime," said Darius Lakdawalla of the nonprofit Rand Corporation. (This paper was funded by a grant from Pfizer and the National Institute on Aging.)

Lakdawalla and colleagues used computer models of price regulation in 19 countries to simulate the impact of price controls that cut drug company revenues by 20 percent.

They said introducing price regulations into a largely unregulated market like the United States would result in less investment in developing life-saving drugs, which in the long run would reduce the life expectancy of Americans.

"We found longevity declines on the order of about a half of year for people at the age of 55 when you look out to people who are alive in 2050 and 2060," he said.

A team of researchers that included Harvard economist David Cutler, a health policy adviser for President-elect Barack Obama, suggested in the same journal that drug spending growth rates had reached a "turning point."

They noted that while drug prices tripled from 1997 through 2007, spending in 2007 grew just 1.6 percent, the slowest rate since 1974, as many brand-name drugs lose patent protection.

Cutler and colleagues noted that prescription drug spending trends have changed dramatically in the past five years, and assumptions based on older trends no longer apply.

The Health Affairs special issue can be found here.

And Reuters coverage can be found here.
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Take A Deep Breath....

12/12/2008 06:11 PM |

Another sign that we have gone crazy...

FDA panel votes down two asthma meds

See Full Story

Now who will track the kids who die because they don't get the meds they need or turn to alternative treatments or OTC products? At least following the signal and figuring out the source would have been more rational and compassionate...

I found this post from FiercePharma said it best...

1. Why don't you add the web address where the public can comment to the FDA?
2.How DARE this eletist godlike panel decide what legal drugs I am allowed to take for my asthma.
It is MY choice if the short term benefit of a LABA is worth the long term potential risk.
3. I am allergic to Advair (unable to digest the lactose based carrier), to get the LABA & steroid I have to take them separately.
The god damned FDA Panel has no right to limit or deny me this legal medicine that can save my life.
The FDA panel should NOT make decisions about how to deliver the drugs (separately or together.) If the LABA is legal in Advair, then it is legal. Denying the use in other (competitive) medicines is dicriminatory, increases the risks to my life, and raises the prices. It is also illegal for Advair to have a monopoly- even if the FDA created it.
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Let Threedom Ring

12/12/2008 04:14 PM |

Wow.  Healthcare reform.

President-Elect Obama, in officially introducing Tom Daschle as his HHS Secretary-designate, said (in effect) "if not now, when?"

Okay, got that.  But many questions remain unanswered, like ... how.

One item that will be at the core of the agenda (even though the administration won't explicitly call it by its real name) will be pharmaceutical price controls. 

There will be three immediate bites at the price control apple:

The first is the revocation of the Non-Interference Clause.  By so doing the government will be able to "negotiate" prices for Part D drugs.  That's kind of like negotiating with your hands tied behind your back and a gun pointed at your head.  There's also the potential for Uncle Sam to dictate that Part D prices be tied to prices in other countries -- a kind of Medicare reference price.

Bite #2 is importation.  Even though such a program won't save any money (less than .1% of drug spending according to OMB) and is fraught with safety issues, it does present the opportunity to import de facto price controls.  Would a Secretary Daschle provide Secretarial Certification?  Do the ends justify the means?

Bite #3 is comparative effectiveness.  Senator Baucus has this as an integral part of his package and it would be surprising if others (specifically Senator Kennedy) wouldn't do the same.  While comparative effectiveness isn't, per se, a price control mechanism -- it's the HOV lane to that destination a la healthcare technology assessment and a NICE-like proposition.

(Senator Baucus' legislation -- at least the 2008 version -- says the work of this new AHRQ-based body couldn't be used for CMS reimbursement decisions.  Sure.  And if you believe that one, I've got a Senate seat to sell you.)

And it's important to note that all three of these "bites" can happen simultaneously, separately, before, during, or as part of a more comprehensive Administration-reform initiative.

Let threedom ring -- but remember for whom the bell tolls.
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The Day the Earth Stood Stool

12/12/2008 01:39 PM |

According to the AP's Matt Perrone:

The AP (12/12, Perrone) (courtesy of the DIA briefing) the Food and Drug Administration (FDA) stated that it "will add the sternest safety warnings available" -- the so-called black-box warning -- "to prescription drugs used to cleanse the bowel before colonoscopies." The FDA was spurred into action after it "received more than 20 reports of a rare, but serious form of kidney failure among patients taking the drugs, known as oral phosphate products." Therefore, Salix Pharmaceuticals' Visicol (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous ) and OsmoPrep (sodium biphosphate, sodium phosphate) will now include a label that "warns that the drugs should be used with caution in older patients, those that suffer from dehydration and kidney disease, or those that take medications that affect the kidneys."

Wait there's more. 

Oral sodium phosphate drugs, "sold with and without a prescription, have been associated with acute phosphate nephropathy, the kidney injury," and it "may lead to permanent kidney damage," Bloomberg News (12/12, Blum) adds. According to Joyce Korvick, M.D., deputy director of the agency's Division of Gastroenterology Products at the Center for Drug Evaluation and Research, "one reason for the risk might be that some people may be dehydrated and not drinking enough fluid when they use oral sodium phosphate products for bowel cleansing, despite the instructions on the products," WebMD (12/11, Hitti) reported. Meanwhile, the FDA is also recommending "that consumers not use over-the-counter oral sodium phosphate products, such as Fleet Phospho-soda, for bowel cleansing."

Those "treatments also shouldn't be used for bowel cleansing, and will get new warnings" as well, HealthDay (12/11, Reinberg) added. "At lower doses, however, they are safe for use as laxatives, the FDA said." But there "are alternatives to these preparations that can be used for bowel cleansing, including GoLYTELY and HalfLytely Bowel Prep," Dr. Korvick pointed out. Meanwhile, Hemant K. Roy, M.D., of Evanston-Northwestern Healthcare in Illinois, who wrote an editorial in the Archives of Internal Medicine that accompanied a study on "the risks of oral sodium phosphate" solutions, "stressed that warranted concerns about phosphate solutions shouldn't keep patients from undergoing colon cancer screening." The (NC) Triangle Business Journal (12/11, Coletta) and MedPage Today (12/11, Gever) also covered the story, as did the Los Angeles Times (12/11, Maugh) in its Booster Shots blog.

        Drugmaker recalls over-the-counter bowel cleansing solutions. In a separate article, Bloomberg News (12/12, Pollack, Blum) reports that "C.B. Fleet Co., a closely held maker of laxative products, said it was voluntarily withdrawing its oral, over-the-counter bowel cleansing solutions after U.S. health regulators warned such drugs may harm the kidneys." Specifically, the drugmakers are recalling "Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System used to clear the bowels before a colonoscopy," a "decision [that] was made because the Food and Drug Administration said...that this class of drugs should be available only by prescription."

Doesn't the FDA have better things to do with it's time?  Or put another way:  has the regulatory apparatus of the nation state evolved to the point where it now has to tell people how to cleanse it's collective bowels safely and effectively?  Apparently a manufacturer, in response to the black box put on the label because 20 people are too stupid to follow directions or not drink a case of beer before undergoing a colonoscopy, has pulled it's product.  And thank goodness the media is there to cover this story.....

There's always my grandmother's recipe for fruit compote....

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Mundy Shills For Nissen, Slimes Woodcock

12/12/2008 04:25 AM |

But then again the girl couldn't bring herself to report that when Scott Gottlieb was at FDA -- and before -- he still saw patients in the ER. Her reporting in this piece, particularly her backhanded slap at Janet Woodcock as someone who hasn't or couldn't reform the FDA is short of slander....

"People close to the industry have been floating the names of other candidates to run the FDA -- including Janet Woodcock, a senior official at the agency -- who are seen as less likely to carry out a thorough overhaul of the FDA. Some Democratic aides have suggested Ms. Woodcock as a possible interim chief while a permanent leader is vetted."

Disgusting. And it just so happens that with the possible exception of Steve Nissen whose own conflicts, skeletons and yet to be revealed corrupt behavior while at Cleveland Clinic (most notably his not so veiled threats against companies that did not use him to conduct research), most of the other serious candidates for FDA commissioner have great respect for Dr. Woodcock. But then again, they are actual physicians, not journalists who failed to reveal they were at the same time working for left wing think tanks like Mundy...

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