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...

Read article here
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Backward Healthcare Reform

12/11/2008 04:11 PM |

Word is from that some in healthcare policy land are upset that Peter wrote a piece critical of the Baucus proposal to examine the comparative effectiveness of new drugs the way NICE does which could lead to rationing. Note to Peter's critics -- our focus is on people and innovation, not a particular Beltway interest or position. No one tells us what to say or do.
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NICE to the Max

12/11/2008 12:12 PM |

Let’s be honest --the fundamental assumption behind the push for a comparative effectiveness agency in the US is that high drug prices are the primary reason American healthcare costs are on the rise. That's simply not true. Drug prices went up less than 1 percent last year, well below the rate of inflation. Pharmaceuticals are about 11% of our national healthcare spend – with on-patent medications representing only about 7 percent. (Something to remember when we debate the non-interference clause and drug importation.)

In theory, properly designed comparative effectiveness studies can be a valuable tool in patient care. In theory. But in practice, in an increasingly personalized world, do large scale studies such as ALLHAT and CATIE really help? Marginally – at best. But all they really end up accomplishing is reaffirming the outdated methodologies of a cost-based system, when what we really need are the proper tools for patient-centric medicine.

While it’s true that comparative effectiveness and healthcare technology assessment (HTA) aren’t the same thing – the question on the table is whether one inevitably leads to the other. And with all the attention being paid to the “need for a US NICE,” the answer is “yes.”

To read more on this topic – and why Senator Baucus needs to go back to the drawing board, click here.

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Time(s) to Buy Generic Newpapers

12/11/2008 02:45 AM |

The out of touch editorial board of the NY Times writing from the only valuable asset left in the Sulzburger empire (the superfluous new building on 8th Avenue) tries to explain would use generic drugs but for the advertising efforts of brand name drug companies.

Which is sort of like saying the NYT readership should continue to decline as people just pick up the news from any old source even in the face of those annoying and relentless ads the paper keeps running...

What I find interesting is that there are actually still 40 pages in the paper's section A...

Read More

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Lose Weight, Earn Money

12/10/2008 08:34 PM |

Wny not extend this concept to every aspect of health care possible? Why not pay people for NOT using health care services, for staying healthy, for exercising?

Stay healthy, pay less.
Get healthy, earn money
Prevent disease, get paid.
Read article here
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Blagojevich Poised for Reimportation to Prison

12/10/2008 01:57 PM |

Lest anyone forget, the indicted Democrat governor had lots of friends the last time he peddled his failed and fudged I-SaveRx program to reimport drugs from wholesalers in Canada, Ireland and other places that Blago made up on the fly....another scam:

"Blagojevich has been among a growing bipartisan group of politicians that is fighting Bush on the importation issue. He and U.S. Rep. Rahm Emanuel, D-Ill., contend that increasing drug imports will create competitive pressures that will force pharmaceutical companies to lower their prices in the United States. The two have even organized a program, so far lightly used, in which residents in Illinois and a few other states can purchase drugs through the Internet from Canada and Europe."

Canada considers plan to stop Internet, mail-order drug sales to Americans.

Source: Chicago Tribune (Chicago, IL)

Publication Date: 06-JAN-05

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NICE Runs Surplus By Denying Care

12/09/2008 11:53 PM |

NHS has SURPLUS of £2billion in the bank after underspending
By JO MACFARLANE
Last updated at 2:21 AM on 08th June 2008


Surplus: Shadow Health Secretary Andrew Lansley claimed the government had failed to use taxpayers money to provide care at a time of cuts

The NHS has underspent by more than £2billion after slashing training and cutting patient care.

About two per cent of last year's total NHS budget was not spent - just two years after the NHS was £547million in debt.


Meanwhile biotech in Britain in dying....thanks to NICE


In 2007, Sir David Cooksey, one of the fathers of British biotech said that "The UK is home to the strongest medical research community in Europe, yet there is no framework for bringing innovation from university laboratories and research organisations into the business world. The presence of the drugs-rationing group the National Institute of Health and Clinical Excellence adds a layer of bureaucracy absent in Europe or the United States."

Now...
Read Here

UK biotech leaders demand government investment for its survival

Monday 8 December 2008
Simon Varcoe - Reporter

Sir Christopher Evans, head of the biotech fund manager Excalibur, and 21 other leading figures in UK biotech are calling on the UK government to make significant investment in the sector to ensure its survival.

Peter Orzsag, the CBO Director who believes innovation is the source of many of the health care systems dysfunctions should be happy.   Rationing innovation saves  money...kills innovation.    I am sure the perpetual priapism of self pronouncement against medical progress such as Merrill Goozner and Healthcare Renewal should be covulsing with joy over the demise of innovation and the surplus of dollars due to the denial of care as the result of comparative effectiveness.   Dollars in the counting house from rationing.  If only Dickens were alive today!  
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Will NICE Suffice?

12/08/2008 04:08 PM |

Lots of letters in today's edition of the New York Times on NICE and the issue of cost-based vs. patient-centric care. To see them all, click here.

Here's my contribution:

To the Editor:

The National Institute for Health and Clinical Excellence in Britain is set to lift its ban on several kidney cancer drugs. The move will give patients access to lifesaving medicines that had previously been deemed “too costly” to cover under public health insurance.

This reversal is effectively an acknowledgment that the agency hasn’t worked as intended. By denying patients access to cutting-edge treatments simply because of cost, it has heartlessly put lives at risk.

Peter Pitts
New York, Dec. 3, 2008

The writer is president of the Center for Medicine in the Public Interest and a former associate commissioner of the Food and Drug Administration.

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Dr. Woodcock: Sailing into the Wind

12/05/2008 07:17 PM |

Barbara Stanwyck (the actress) said of egotism that it's a case of mistaken nonentity.  The same can be said the rampant speculation and self-promotion regarding who is going to be the next FDA commissioner.   Lots of people weighing in who don't know the full story or the full weight of the  job.  Lots of second guessing.  Only one or two  people who are willing to stand and accept the responsbility and stand by decisions regardless of what is said to attract the crowd or generate a headline. 

That's why Janet Woodcock's statement regarding Vytorin and Avandia are so courageous and on point: "People have convicted them without a trial."   But she has taken similar stands on drugs that others though should have been approved, but have not, because of lack of compelling benefit data, and on demanding that FDA have more hires, that staff actually get paid on time, that the new FDA building have a cafeteria(!).   

Drugwonks has made it clear who it thinks should NOT be FDA commissioner.  But with regard to who should FDA Commissioner, it should be someone who can emulate and admire Janet Woodcock's dedication to science-based overhaul of the agency.


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It makes you wanna SHOUT!

12/05/2008 02:54 PM |

According to the Wall Street Journal, HHS Secretary-Presumptive Tom Daschle wants Americans to host “holiday-season house parties to brainstorm over how best to overhaul the U.S. health-care system,” He’ll make the suggestion as part of his case for health reform in a speech to be delivered in Denver today.

How about a healthcare toga party?

(PS/ Why hasn't Daschle's nomination been made official yet?)

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Stupak Attack

12/05/2008 01:32 PM |

Congressman Bart Stupak does not have the courage of his convictions.

Here’s what he wrote to President-Elect Obama:

"I would encourage you not to appoint any current senior FDA employee as Commissioner or Interim Commissioner of the FDA … Current senior FDA employees are too close with the industries they regulate, creating a question of who they are working for."

He’s a bully – and a coward since he didn’t back up any of his accusations with even a scintilla of evidence – and didn’t name any names, yet he’s calling for a "complete change in the FDA's leadership."

Here’s some news for Mr. Stupak – there are precisely zero political appointees (“Schedule C” employees) in any of the FDA’s five centers (drugs, biologics, food, medical devices, and veterinary medicine).  None.  And all five center directors are career public health officials. And Mr. Stupak – the 11,000 career staff at the FDA know precisely who they work for – the American public.

It is an absolute abomination that Congressman Stupak should cast such squalid aspersions on the men and women of the FDA who work long hours under tremendous pressure with little recognition at government pay to help protect and advance the public health.

Is the Honorable Mr. Stupak accusing career FDA staffers of taking bribes?  If so, let him say so.  If not, let him apologize.  

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The Wave of the Present

12/04/2008 01:46 PM |

Just as the FDA dips its toes into the world of social media with via a new partnership with WebMD (details here), some pharmaceutical and medical device companies are stepping into something else -- abuse of social media.

Here's the dénouement -- social media must play by the same regulatory rules as, well, pre-social media.

After all, if the medium is the message – and the message is regulated – than the same rules apply. Specifically FDA rules, guidances – and draft guidances.  This is not rocket science and pharmaceutical and medical device companies should know this without having to be told.

Alas, that does not seem to be the case with some.  

In September, the FDA sent a letter to Shire Pharmaceuticals, asking it to pull a YouTube video for Adderall XR that the agency said overstated the hyperactivity drug's effectiveness and omitted risk information. The company said it didn't intend to post the video on the site and, upon learning of the posting in May 2007, promptly removed it.

The newest culprits in this space are YouTube videos for medical devices sold by Abbott Labs, Medtronic and Stryker. The Prescription Project (with whom we share almost no common ground) points out that these videos violate federal rules because they don't contain required warnings and disclosures.  And they’re right.

Stryker said it wouldn't comment because the issue was before the FDA. Medtronic said it is committed to adhering to FDA guidelines for direct-to-consumer advertising. The company said the video in question had been taken down. An Abbott spokesman said the company posted a link to safety and risk information next to its YouTube video, but will from now on embed safety and risk information in such videos.

Social media is the wave of the present and presents powerful new ways to both market to and educate the public. Mistakes such as these are not acceptable and will only lead to more Congressional fist pounding. The good news is that they are easy to avoid.  Just follow the rules.   Social media – indeed all media – must be used responsibly, in compliance, and for the benefit of the public health.

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Making NICE

12/03/2008 05:56 PM |

In his discussion of how NICE covers or doesn't cover cancer drugs Gardiner Harris asserts that I "..likened Dr. Rawlins (the head of NIC) and his institute to terrorists and said their decisions were morally indefensible."

Not true. I said that the NICE decisionmaking approach -- which takes years -- held patients hostage to a QALY measurment that only took into account what NICE thought was valuable to the NHS, not to the patients themselves. And I said that decision because of its perspective and delay was and will be morally indefensible. I stand by that view and stand by the people who lives are cut short and ruined by NICE.

Innovation is not the problem with health care. Innovation is the solution. Cancer care is a small part of the cost of health care and is often the most effective in terms of reducing expenses and extending life. The question is if we had applied the NICE knife 30 years ago, how many of us, our parents, our siblings, our children would be far worse off (yes -- even dead) because of the absence of products not developed or unavailable due to the cumulative impact of cost trumping care?  Read More & Comment...

Caveat Baucus

12/03/2008 02:44 PM |

Do we want British-style comparative effectiveness?  Is NICE the answer? 

The most recent installment of the New York Times series, “The Evidence Gap,” explores NICE and the proposition of balancing cost-based government concerns with patient-centric care.

And ground zero is kidney cancer. According to the Times’ story:

"When Bruce Hardy’s kidney cancer spread to his lung, his doctor recommended an expensive new pill from Pfizer. But Mr. Hardy is British, and the British health authorities refused to buy the medicine. His wife has been distraught."

“Everybody should be allowed to have as much life as they can,” Joy Hardy said in the couple’s modest home outside London. "It’s hard to know that there is something out there that could help but they’re saying you can’t have it because of cost. What price is life?”

Surprisingly the Times’ reporting is a bit old – considering that earlier this week NICE said that their ban on drugs that can give kidney cancer patients many months of extra life is to be lifted. According to the Guardian, “"The move follows British Health Secretary Alan Johnson's decision this month to overhaul the way new medicines are assessed for terminally ill patients. Denying cancer patients access to drugs that are widely available abroad has become a major political issue." 

Caveat Baucus.

For more on NICE and the issue of cancer drug denial, see here.

To see how other nations (in this case, Mexico) are developing their own comparative effectiveness protocols, see here.

And consider the words of Professor Atanacio Valencia, of the Mexican Institudo Nacional de Salud Publica who cautioned. “A good economic analysis is not a faultless crystal ball. Don’t make the remedy worse than the disease.”
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