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.
  Read More & Comment...

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 But all they really end up accomplishing is reaffirming the outdated methodologies of a cost-based system, when what we really need are the proper tools for patient-centric medicine.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.

  Read More & Comment...

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

  Read More & Comment...

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
  Read More & Comment...

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

  Read More & Comment...

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!  
  Read More & Comment...

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.

  Read More & Comment...

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.


  Read More & Comment...

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?)

  Read More & Comment...

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.  

  Read More & Comment...

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.

  Read More & Comment...

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.”
  Read More & Comment...

Commonwealth Fund Flunks Stats 101

12/03/2008 12:38 PM |

Nirit Weiss, MD (a neurosurgeon with a Master of Business Administration and a specialization in healthcare economics) has written a blistering appraisal of heavily reported and oft cited July 2008 Commonwealth Fund report, “Why Not the Best?”

After reading her analysis, perhaps a better title would have been “Why Not the Best Use of Statistics?”

In addition to entirely discrediting the report’s methodologies, the article (in a series of very disturbing sidebars) shows that the mainstream media was either lazy or complicit (or both) in reporting the story.

Weiss’ full exposé can be found here.

Weiss writes:

“On July 17, 2008, the Commonwealth Fund commission published its second Scorecard report, Why Not the Best?: Results from the national scorecard on U.S. Health System Performance, 2008. Its findings that U.S. health care performance had not improved since 2006 and that access to health care significantly declined were again reported widely in the media and in a way that gave wide credence to the Scorecard’s conclusions (see sidebar). As the New York Times noted, The findings are likely to provide supporting evidence for the political notion that the nation’s health care system needs to be fixed.”

However, the 2008 Scorecard must be interpreted with caution. In attempting to diagnose the ills of America’s healthcare system, the Scorecard suffers from serious flaws that challenge the validity of its conclusions – flaws that were, essentially, ignored by the authors of the study and completely missed by the media coverage. These flaws fall into three categories:

   1. The methodology by which the data were collected and the studies were designed to address specific questions.
   2. Arbitrary definitions and metrics used to define the concept of “quality” in health care.
   3. Sweeping, broad conclusions that are unsubstantiated by the findings of the study.

1.    Flawed methodology

The 2008 Scorecard is based upon multiple disparate studies, using various methodologies, non-uniform definitions of “benchmark,” and arbitrary assumptions as to what “logical policy goals” are, and what “adequately insured” actually means. The Scorecard attempts to draw meaningful conclusions based on a summation of individual studies with varying sample sizes, varying performance comparisons, and varying data collection techniques.

In peer-reviewed, scientific literature, it is invalid to lump together the results of multiple studies, using multiple methodologies, in the same charts, graphs, and conclusions, without assigning relative weight to the results of the studies. Adding even more to the confusion, many of the reported data are not directly referenced to published studies, so it is impossible to trace and evaluate the sources of the information. A substantial number of the individual analyses were merely described as “conducted by the authors,” limiting the reader’s ability to evaluate the quality and validity of the studies.

Perhaps more troubling are those data which can be traced back to their source studies, and turn out to be based on patient self-reporting. For example, in its section on “quality,” the Scorecard quantified mistakes made in health care delivery according to patient interpretation and self-reporting! Patients were asked how often they felt mistakes were made in their medical care, such as errors in laboratory testing, or medication errors.

2.    Arbitrary metrics used to define “quality”

The entire premise of the Scorecard, is that “quality” in the U.S. Healthcare System can be quantified by assessing mean scores with respect to 37 “indicators” across five “dimensions” of health system performance. The 37 “indicators” across five “dimensions” are modeled after those used in studies of industry, and focus on health care delivery systems performance, which is indeed one component of value and return-on-investment. But it is not the largest determinant of what most Americans would define as “quality.” Assessing the quality of delivery of goods by studying uniformity, for example, is appropriate when evaluating the transformation of undifferentiated inputs into uniform outputs, each machined to be identical to the other.

In other words, the conclusions of the study are dependent on the authors’ assumption that all patients with a given diagnosis, say diabetes, are otherwise identical, and should have no difference in outcomes. This input/output calculation disregards the fact that all inputs, such as patients with diabetes, have other comorbidities, and cannot be expected to have the same outcome or outputs.

3.    Unsubstantiated conclusions

The authors of the Scorecard present their results in raw form, and then apply these results to reach broad conclusions, which are several steps removed from the data actually being presented; indeed, the data presented often does not directly support or relate to some of the Scorecard’s conclusions. Because there are so many such examples, it is reasonable to summarize them. In general, the authors conclude that universal health insurance in the U.S. would improve quality at substantial cost-savings, that increased primary care and preventative care always improves outcomes at reduced cost, and that “preventable” hospitalizations and outcomes are preventable entirely by policy changes in health care delivery, in the absence of a drastic culture shift in this country. These conclusions may have some validity, but they are not directly supported by the data presented.

Given the potentially far-reaching implications of publications such as the 2008 Scorecard on policy-making and financing of healthcare, the authors and sponsors of these studies must be held to the same high standards as are physicians and scientists when reporting results of their investigations. This responsibility must be shared by the media, who control the dissemination of information, and must present the results of such studies in as objective and informative a manner as their audience deserves.

As Trevor Butterworth comments in a sidebar:

“Both the Washington Post (“U.S. Health Care Still Ill, Survey Finds”) and Forbes (same headline) ran an article by Healthday News, which simply reported the Scorecard's conclusions and cited Karen Davis, the Commonwealth Fund's president, and Cathy Schoen, the Commonwealth Fund's senior vice president for research and evaluation, to explain the significance:

“‘The United States also lags behind other countries in health-care results, Schoen said. ‘Even where the U.S. average improved, other countries have improved much more rapidly,’ she said. ‘As a result, we are falling further behind the leaders.’”

No other expert opinion was offered in either article, but Post readers were invited to visit the Commonwealth Fund's website “To learn more about health care in the United States.”

A half-truth, as my grandmother used to say, is a whole lie.
  Read More & Comment...

Who Moved My Cheese?

12/02/2008 11:50 PM |

Our friend Peter Huber (senior fellow, Manhattan Institute) has a provocative article in the current issue of City Journal, “Curing Diversity.”

Huber discusses, among other things, the current inflection point of innovation vs. cost and how we got to where we are. 

Some of his comments to whet your appetite”

“Pharmacology has found better ways to tame smaller shards of hostile life while dodging friendly molecular bystanders. And in scrambling to do all that, it has revealed that we aren't all the same deep down, neither in sickness nor in health.”

But …

“The Fourteenth Amendment doesn't guarantee equal protection at the pharmacy … So the stage is set for a long battle between radically new medical science and a senescent, unscientific vision of how diseases are cured and what the "health-care system" ought somehow to deliver.”

Huber is the first policy wonk (as far as I know) to compare a restrictive formulary to a cheese wheel:

“Charles de Gaulle once wondered how anyone could govern a nation that had 246 different kinds of cheese. Designer medicine could probably stock that many varieties on just the cholesterol shelf of its fromagerie. The simplest fix: fewer cheeses.”

There's a punchline in there somewhere.

  Read More & Comment...

Kidney Punch to NICE

12/01/2008 05:14 PM |

According to a report in today’s Guardian, the ban on drugs that can give kidney cancer patients many months of extra life is to be lifted. At least two, and possibly all four, of the medicines that had previously been deemed too expensive to prescribe will be approved by the National Institute for Health and Clinical Excellence (NICE) early next year.

What caused the the reversal?  Why evidence, of course.

"A spokeswoman for NICE said the organization was looking again at all the drugs because there was more evidence submitted during a couple of periods of the appraisal process by manufacturers, which needs to be discussed by the [appraisal] committee. We will publish a next draft within four weeks of the committee's meeting in January and issue final guidance in March 2009.”

Couldn't have been anything else, right? Well ...

"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."

For more on this issue, see here.  

And for the complete Guardian article, see here.

Perhaps HHS Secretary/Healthcare Czar-Designate Daschle should give the Honorable Mr. Johnson a call. And maybe he should conference-in Senator Baucus.

  Read More & Comment...

ALLHAT Jazz

12/01/2008 03:02 PM |

Per the renewed interest in ALLHAT -- and the pros and cons of large scale, government-funded comparative effectiveness trials -- some further comment from Michael Weber, MD -- one of the original ALLHAT investigators (and Chairman of the Center for Medicine in the Public Interest):

Using ALLHAT as an example of an “evidence gap” could be misleading, for the issue is not the information produced by ALLHAT, but rather how it’s interpreted and used.

Most experts, myself included, have concluded that diuretics are highly useful drugs in treating hypertension, and may even be underutilized.  But there is no convincing evidence that they are superior to other drug classes.

Admittedly, diuretics are cheap to acquire, though not necessarily cheap to use. Because they cause unwanted changes in such factors as potassium, glucose (which can lead to diabetes) and uric acid ( which can lead to gout), the additional costs of extra laboratory tests, follow-up doctor visits and corrective therapies must be reckoned in.

In fact, the British National Health Service, which is guided in drug selections by its highly cost-sensitive National Institute of Clinical Excellence, favors amlodipine (one of the diuretic’s competitors in ALLHAT) as the usual starting therapy for hypertension. This recommendation is based on the ASCOT study that found that a beta-blocker/diuretic combination (a favored treatment in ALLHAT) was significantly less effective than a combination of newer drugs in reducing fatal and non-fatal cardiovascular events and strokes.

Another powerful study, ACCOMPLISH, was recently presented at the scientific sessions of the AmericanCollege of Cardiology and is expected to be published before year’s end. This much discussed trial has also indicated that diuretics  --  valuable as they are  --  may not be as effective in prolonging life and preventing heart attacks as other choices.

So the claim of an evidence gap is not based on a disregard of evidence, but in fact demonstrates that the opposite is true. Clinicians apparently are aware of the full spectrum of evidence, not just selected portions promoted by a government agency. From the perspective of patients with hypertension, this surely is good news.

(For more on ALLHAT, see here.)

  Read More & Comment...

Hecho en Mexico

11/30/2008 05:22 PM |

Last week I participated in a two-day seminar held by the Consejo de Salubridad General of Mexico. The topic was “Farmacoeconomia: una nueva era en la toma de decisiones,” (“Pharmacoeconomics: a new age for decision making.) The conference’s subtitle was important, “una vision internacional.”

The “internacional” part consisted of myself, Michael Drummond, Professor of Health Economics (University of York), Professor Jacques Lelorier, Chief of the Pharmaco-economics and Pharmaco-epidemiology research unit at the University of Montreal, and Kalipso Chalkidou, Acting Director of Policy Consulting at NICE.

The seminar was designed to debate and discuss Mexico’s new pharmaco-economic guidelines for their national formulary. And there was as much debate as discussion. (The audience was comprised of about 100 members of various Mexican government health authorities – and they were not passive observers.) The opening remarks by Stephano Bertozzi (Instituto Nacional de Salud Publica) set the tone for the event, “We need to spend more and spend more wisely.”

Michael Drummond’s presentation was a primer on the various types of evidence used in healthcare technology assessments. Nothing new – but a valuable view into the soul of HTA. Dr. Drummond’s take-away message was that decisions made via HTA are economic decisions – not necessarily medical ones. He also pointed out that using RCTs as the mainstay of comparative effectiveness measures was a flawed proposition and that other evidence – such as observational studies and real-time outcomes data needed to become part of the broader HTA equation.

I was up next, and the gist of my talk was that decisions should be made on patient-centric rather than cost-based platforms – and that reimbursement choices based on short-term budgetary considerations can have expensive (for the government) and dire (for the patient) consequences. My presentation can be found here.

Third on the agenda was Professor Jacques Lelorier who gave a very provocative presentation on the gaming of the comparator issue in general and by Canadian authorities (CDR) in particular – which does not tell the innovator company what comparator it has chosen and then, once a decision has been made, won’t share the data used in the process. He made the point (echoed by others during the course of the event) that when a particular HTA review finds a product to be outside of the selected cost-effectiveness parameters, “the answer is no,” but when the parameters fall within the selected criteria, “the answer is maybe.”

Kalipso Chalkidou gave an overview of NICE – making a point of the fact that NICE is not a reimbursement agency and does not deny access to pharmaceuticals. She also discussed the pending policy (in the UK) of providing physicians with financial “incentives” if they move patients from on-patent medicines to generic alternatives “Incentive” -- such a nice word when a government uses it. Can you imagine what it would be called if this same technique was used by an innovator company? (Hint – “bribery.”) Dr. Chalkidou also noted this policy is “pending” because it is being challenged in court. She also pointed out (vis-à-vis statins) that if there was “any proof” that an on-patent product was “better” than a generic that NICE would be glad to reconsider its current position on the matter. I will shortly send her a link to the BMJ-published THIN study that shows why switching patients from on-patent atorvastatin (Lipitor) to off-patent simvastatin (generic Zocor) has proven to be very expensive to the British healthcare system because of its disastrous and deleterious impact on patient health. (For more on the THIN study, see here.) 

Day Two of the seminar was comprised of Mexican health officials and academics presenting their views on pharmaco-economics and HTA. Some worthwhile and representative remarks:

“Developing guidelines is one thing -- making disastrous implementation mistakes is something else. We must have confidence in the people doing our HTA reviews and understand the relative strengths and weaknesses of the data. We must have clarity about appeal guidelines. A good economic analysis is not a faultless crystal ball. HTA has threats as well as opportunities.” (Atanacio Valencia, Institudo Nacional de Salud Publica)

“HTA isn’t a decision – it is the evidence to assist in making a decision.” (Maria Cristina Gutierrez Delgado, Secretaria de Salud). Her presentation was on a Mexican HTA analysis of the HPV vaccine – an analysis that showed the vaccine not to be cost-efficient. The Health Minister, however, decided to go against that recommendation.

Stephano Bertozzi spoke about the need to create a formalized training program for those who prepare HTA studies as well as for those who will make the final reimbursement decisions.

Octavio Amancio Chassin (Consejo de Salubridad General), made the excellent point that HTA must go “beyond the QALY,” taking into careful consideration a variety of factors such as the financial impact associated with caregivers.

Being able to participate in this event and to view the Mexican public health community discuss and debate how to set up an HTA authority convinces me of five things:

1. HTA can be a valuable tool when the right tools are used the right way;

2. HTA must be a combined and collegial effort of government officials, trained academics, physicians and pharmaceutical companies;

3. A variety of evidence must be considered – from RCTS to observational studies to outcomes data;

4. HTA must be as much a patient-centric proposition as a cost-effectiveness mechanism;

5. All aspects of HTA – from the design to the decision to the appeals process must be open and transparent

As we in the United States begin to think seriously about HTA we absolutely must remember that it’s more than just “comparative effectiveness.” And a good way to start having a serious conversation about the issue would be to convene experts and discuss the right way to move forward.

I respectfully suggest to Senator Baucus and Senator Conrad, before they offer legislation setting up an American comparative effectiveness body (within AHRQ or anywhere else), that they look at the process being used by our NAFTA neighbors to the South and carefully consider the warning of Professor Atanacio Valencia, “Don’t make the remedy worse than the disease.”

  Read More & Comment...

Why ALLHAT is a Turkey

11/28/2008 09:07 PM |

Andrew Pollack tells the story of ALLHAT the supposed gold standard of comparative effectiveness trials in today's NYT.

CMPI's chairman Michael Weber is quoted:

“There was a feeling there was a political and economic agenda as much as a scientific agenda,” said Dr. Michael Weber, a professor of medicine at the Health Science Center at Brooklyn, part of the State University of New York, who had been an investigator in the study but afterward became one of its leading critics. “They pushed beyond what the data allowed them to say.”

Critics said the rules of the trial had favored the diuretics. If the first drug did not adequately lower blood pressure — as happened in more than 60 percent of cases — a second drug could be added. But that second drug was usually a type that worked better with diuretics than with ACE inhibitors.

FDA's Bob Temple says: “This is the largest and best attempt to compare outcomes we are ever going to see,” he said. “And people are extremely doubtful about whether it has shown anything at all.”

So who is in favor of this big trials?

Those who want the government to dictate to doctors what to prescribe based on cost-driven clinical trial designs or think they will spit out precise answers that health plans can use to save money. But in fact such trials themselves have a political edge and often lead by people who themselves have a bias: Which is why Curt Furberg, the man who played fast and loose with the data to claim calcium channel blockers cause cancer, was forced to resign. Actually not the only reason. The other reason: the design of ALLHAT exposed African Americans to an excess risk of stroke and stroke related death. President-Elect Obama and his health advisers should bear that in mind in considering Furberg for any position.

So what's the verdict on comparative effectiveness research? Clinical trials of the size, scope and design of ALLHAT are inconclusive and often outdated, if not politically motivated. So what's the alternative that everyone is seeking to spend billionns on?

"Dr. Clancy (Carolyn Clancy director of the federal Agency for Healthcare Research and Quality) said that her agency was now mainly using insurance records to judge how treatments perform. While clinical trials are the gold standard, she said, they are costly and time-consuming.

And, she added, “You might be answering a question that by the time you are done, no longer feels quite as relevant.”

And that's going to save the US health system billions?

Research on how to achieve the best outcomes for patients is possible. But neither the ALLHAT approach or the review of insurance records is the way to do it.

  Read More & Comment...

Tastes Like Chicken

11/26/2008 10:55 PM |

As we prepare to think "turkey" -- let's first talk "chicken."

As in "Chicken Little."

I share this because, having just landed in Mexico City for a conference on HTA and pharmacoeconomics, I can attest to the fact that the sky is not falling – notwithstanding a story in today’s Washington Post that the FDA is teetering on the brink.

Consider the opening paragraph:

“Shaken by a series of alarming failures, the FDA desperately needs an infusion of strong leadership, money, technology and personnel -- and perhaps a major restructuring, say former officials, members of Congress, watchdog groups and various government reports.”

First of all, the agency already has some very high caliber leadership – but a new Commissioner with vision, guts and communication skills will absolutely make things better. The FDA is a very hierarchical agency. And it’s very true that more money, personnel and technology are must haves. Particularly technology.

But folks, as Pollyanna-ish as it may sound – the agency that parlor game pundits, some of our elected officials and so-called “watchdog groups” are bemoaning as broken – is actually working pretty well considering withering media attacks, internal score-settling and general hand-wringing by people who mostly have no idea what they’re talking about.

And some who do and should know better.

I am surprised by the comments of my former colleague Bill Hubbard who is quoted in the Post as saying, "FDA is close to being at a tipping point -- the agency is hanging on by its fingertips in protecting us."

If that’s true today, then it must have been true when Bill and I were at Parklawn together. And it wasn’t true then. Bill wants the best for the agency – but tacking to the political winds is bad strategy.

"Everywhere you go, you hear the same chorus: The agency's in trouble," said David A. Kessler, who served as FDA commissioner under Presidents George H.W. Bush and Bill Clinton. "There's a general perception the agency is suffering mightily."

It’s important to read what Dr. Kessler said – that there’s a general “perception” – that’s a lot different from it being true. But minus a smart and robust communications strategy – perception becomes reality. And the FDA has been minus a smart and robust communications strategy for too long.

And then there are those with personal agendas.

"I'm afraid we're going to see more horrible things happen if we don't get our act together on this," said David Ross, who was a drug reviewer at the agency for 10 years.

Funny the article should quote David Ross – who has a chip on his shoulder the size of Gibralter. It’s kind of like asking Hillary Clinton to write a job recommendation for Monica Lewinsky. It’s also poor reporting that Ross’ conflicts weren’t noted.

Sloppy journalism and bad editing.

And then there are those who point out how well the FDA was run when they were running it:

"The agency needs to get back to using science as the basis for its decision-making," said Jane E. Henney, who ran the FDA under Clinton from 1998 to 2001.

Let’s face it -- Jane will not go down in history as one of the great FDA Commissioners. And shame on her for saying the agency isn’t using science, first, last and always as it’s decision-making compass.

The article makes one excellent point that needs to be repeated and repeated and repeated, “While the agency has received some additional money and personnel to help implement new drug safety powers, many say it is overdue for a doubling of its budget.”

That’s change we can believe in – lots of change.

And, according to Mark McClellan – already considered by many to be one of the FDA’s Hall of Fame Commissioners -- "There's broad bipartisan recognition from consumer groups and from industry that the FDA needs more resources. The most important thing is overall effective leadership that leads in a way that establishes public trust."

Amen.

And Happy Thanksgiving.

  Read More & Comment...