The Best and the Brightest..(and then there's me!)

06/16/2009 05:52 PM |

I chatted with members of the The Council for American Medical Innovation

It is a decidely bi-partisan and eclectic group that share a geniune concern about the future of biomedical innovation and whether it will come out whole in health care reform.   I am an a priori skepticism about the value of such entities (my feeling about rock group re-union tours)  but sincerity counts for a lot and this group has a passion for the issue, which of course I share.   And they have framed the issues clearly as you can tell from the video.  Coming to a town near you. 

Click Here to View the Video

  Read More & Comment...

A Trillion Dollars in Incompetence...

06/16/2009 05:40 PM |

A Trillion Dollars in Incompetence

By Robert M. Goldberg
Posted June 16, 2009

Bonaparte famously said to "never ascribe to malice that which can adequately be explained by incompetence."

Thus stands the Kennedy health care bill, placeholder for the hard left dream of a government takeover of the American health system. The bill is a taxpayer-supported monument to the lethal stupidity of this statist objective that will leave Americans with fewer choices, more government control over medical decisions, higher taxes, and a smaller private health insurance market (mostly union health plans paid for by taxes on the health benefits of non-union workers) that punishes efforts to reward healthy behavior.

Over ten years: 16 million more people with new insurance, 23 million forced into public plans. A trillion dollars at least. By way of comparison, from 1997 to 2006 the number of people with private health insurance grew by 5.4 million, while Medicaid and SCHIP coverage grew by 13 million for a total of 18.4 million. Total cost to the government: $40 billion. Total health care spending over that time period increased by one trillion. Meanwhile, most of the public health care coverage increase during that time -- 60 percent according to a Harvard University study -- displaced private health insurance coverage.

Could the Kennedy bill be any more inefficient at using taxpayer dollars to subsidize misshapen forms of health care coverage? Of course it could. And it is.

Yesterday President Obama told the American Medical Association that "a big part of what led General Motors and Chrysler into trouble were the huge costs they racked up providing health care for their workers -- costs that made them less profitable and less competitive with automakers around the world."

"If we do not fix our health care system America may go the way of GM -- paying more, getting less, and going broke."

Which is why Section 133 of the Kennedy bill grandfathers in every union-negotiated health plan that apes union health plans for workers and prohibits companies from transferring workers into the public "option."

Worried about the cost of retiree health benefits? No problem. "There is established in the Treasury of the United States a trust fund to be known as the Retiree Reserve Trust Fund that shall consist of such amounts as may be appropriated or credited to the Trust Fund as provided for in this subsection to enable the Secretary to carry out the program under this section. Such amounts shall remain available until expended." ("Such amounts" is Washingtonspeak for bottomless pit.) It pays for insurance benefits and 80 percent of claims from $15,000 to $90,000 for all retirees (ages 54-64). Initial cost of this "trust fund": $10 billion.

The Kennedy bill pays for $1 trillion in ineptitude in four ways.

First, it borrows. But who's counting or keeping track?

Second, it creates "Gateways" that are supposed to create groups of purchasers to reduce the cost of insurance. In fact, since insurance companies have already made it clear that they can provide guaranteed coverage without regard to the size of purchasing pools, why are such Gateways necessary? Because, as agents of the federal government, Gateways collect a tax on the insurance premiums of the young, healthy and health-conscious to subsidize the cost of insurance for those who now have no incentive to improve their health.

In fact, insurance plans that actually do a better job of controlling costs or keeping premiums low with better quality are punished under the Kennedy bill: "Any State or participating State shall assess a charge on health plans and health insurance issuer (with respect to health insurance coverage) if the actuarial risk of the enrollees of such plans or coverage for a year is less than the average actuarial risk of all enrollees in all plans or coverage in such State for such years."

Third, in order to subsidize the sort of health plans that broke the bank at GM, the Kennedy bill taxes the health benefits of others, particular those in self-insured corporations that are doing the most innovative things to improve quality and reduce costs.

Fourth, the Kennedy bill gives a Medical Advisory Council power to determine what new technologies and benefits can be covered and are introduced. It's the same technique Obama wants to use to curb the rate of growth in Medicare. John McCain suggested paying for his health care tax credit plan with Medicare savings. During the election, Obama said that "would mean fewer places to get care, and less freedom to choose your own doctors…. I don't think that's right."

Today, Obama would slash payments and choices to seniors -- mostly the sickest -- to help pay for GM-type health plans, retiree slush funds, and the mass relocation of middle-class Americans into a richer version of the Indian Health Service. On top of that, the Kennedy bill costs $1 trillion to "cover" 16 million new people in the process. By tossing 40 million out of private insurance no less. Not only is it not right. It's incompetent.
  Read More & Comment...

A Trillion Doesn't Go Very Far These Days....

06/15/2009 10:26 PM |

Preliminary score from CBO... $1 Trillion for 16 million additional insurance policies....

Read more here
  Read More & Comment...

New FDA Better Than Same Old CBS

06/15/2009 08:06 PM |

ADHD Meds May Hike Kids' Heart Risks
Dr. Jennifer Ashton Discusses New Research Linking Stimulant Drugs and Sudden Death
NEW YORK, June 15, 2009
(CBS)  Are ADHD medications safe for children?

Research released Monday by The American Journal of Psychiatry gives more support to the claim that stimulant drugs usually prescribed for ADHD could increase the risk of sudden unexplained death in children.

On The Early Show Monday, CBS News medical correspondent Dr. Jennifer Ashton what the study might mean for the 2.5 million children taking medication for the disorder.

FDA Issues Safety Communication about an Ongoing Review of Stimulant Medications Used in Children with ADHD
June 15, 2009

Read more here



  Read More & Comment...

From Pink Sheet to Pink Suit

06/15/2009 05:57 PM |

According to the Pink Sheet, “When faced with unpleasant news, people often try to change the subject or even pretend the thing didn't happen. Both of those coping strategies were on display during a June 11 hearing on biologics competition by the House Energy and Commerce Committee's Health Subcommittee.”

Subcommittee Chairman Frank Pallone (D, NJ) said the panel would hold additional hearings that would include FDA and address product safety issues.

Rep. Anna Eshoo (D, CA) “wrangled with Pallone about submitting into the record a letter written by FDA's then Chief Medical Officer Frank Torti that raised serious questions about the approvability of follow-on biologics.”

"These are the ones from the previous administration?" Pallone asked. "We've asked them again in the current administration."

Does Mr. Pallone realize that the career officials who answered his questions the first time are the ones who will answer him once again?  Is he hoping that politics will trump science and the FDA will give him a different answer to the same question?  Obviously so.

And hurrah for Representative Eshoo for sticking to her guns.  We’re big fans – especially since she graced the recent launch of the Center for Medicine in the Public Interest’s Odyssey Project -- a new initiative to ensure that support for medical innovation remains a top priority in any healthcare reform effort. 

Representative Eshoo took the opportunity to speak about follow-on biologics with great intelligence, passion, and poise – three things we could use of as we debate this important topic.  To view her remarks, go to www.cmpi.org and click on the video still of the woman in the stylish pink suit.

Eshoo?  Gesundheit.

  Read More & Comment...

Dollars, Pounds, and Euros

06/12/2009 03:27 PM |

  Read More & Comment...

AMA Finds Its Voice

06/12/2009 03:21 PM |

  Read More & Comment...

Healthy Stewardship

06/12/2009 04:42 AM |

Tonight I attended a dinner sponsored by the Aspen Institute's Health Stewardship Project that brought together a group of journalists, patient advocates and policy experts to discuss comparative effectiveness and the future of innovation.  (How did I get in?)  It was an off the record event but I can say for the most part that despite political and policy differences there was wide agreement that efforts to measure the value of new technologies should encourage innovation, not be generated by government alone but by robust partnerships, should promote healthy and long life, be controlled and easy to use by doctors and patients and not be used to control costs (however this latter objective will be harder to achieve if more health care spending is controlled by government.

There was less said about the role and impact of biomedical innovation on health care costs and society in general but here too there was agreement that more time and effort should be spent educating policymakers and the public about what innovation is and what it delivers. 

Aspen's Health Stewardship Project plays and should play an important role in making health and innovation the cornerstones of health care reform. 
  Read More & Comment...

Amen -- to the Max

06/10/2009 01:22 PM |

The Pink Sheet reports that, “Sen. Max Baucus, D-Mont., is now proposing that CMS or other HHS agencies could not immediately translate results of comparative effectiveness research into health care coverage policies, in CER legislation he introduced June 9.”

The "Patient-Centered Outcomes Research Act of 2009" - stipulates that HHS may use the outcomes of comparative effectiveness research in making coverage decisions "if such use is through an iterative and transparent process which meets the following requirements":

1) "Stakeholders and other individuals have the opportunity to provide informed and relevant information with respect to the [coverage] determination."

2) "Stakeholders and other individuals have the opportunity to review draft proposals of the determination and submit public comments with respect to such draft proposals."

3) "In making the determination, the [HHS] secretary considers (A) all other relevant evidence, studies, and research in addition to such comparative effectiveness research; and (B) evidence and research that demonstrates or suggests a benefit of coverage with respect to specific subpopulation of individuals, even if the evidence and finding from the comparative effectiveness research demonstrates or suggests that, on average, with respect to the general population the benefits of coverage do not exceed the harm."

The bill at strategic spots uses the language "comparative clinical effectiveness" as a means to emphasize that the research itself will not be cost focused, which Baucus noted is key to getting CER into health care reform.

How will comparative effectiveness research generate cost savings without any cost analysis?  According to Senator Baucus, cost decisions will be made by patients and providers. "It is up to them. It is not up to an agency to decide."

Decisions to be made by patients and providers (and in that order).  Now that's what I call "pay-as-you-go."

And amen … to the Max.

  Read More & Comment...

Sock it Toumi

06/10/2009 11:37 AM |

Since taking office in January, US President Barack Obama has taken a number of major decisions to control healthcare expenditure. Two of these should provide potentially significant savings with little investment:

The opening of the US market to follow-on biologics, or biosimilars, with estimated savings ranging from $12 billion over 10 years to $378 billion over the next two decades;^1-2

The lifting of the ban in the 2003 Medicare prescription drug act that prevents negotiation of the prices of medicines purchased for Medicare, and which incurs estimated extra costs as high as $30 billion annually.³

The efficiency of Mr Obama's third decision, to establish the Federal Co-ordinating Council for Comparative Effectiveness Research (FCCCER), is more doubtful. Mr Obama has dedicated $1.1 billion in the economic stimulus package for federal agencies to develop information on the comparative effectiveness of medicines. This decision aims to provide evidence to support value-driven decision-making. Such research is thought to be a potential source of cost-savings, permitting better care decisions to be made and an improved allocation of resources by Medicare, health insurers and even private individuals. The Congressional Budget Office has estimated an impact on healthcare spending of up to five times the total investment, not all of which would be visible as cost savings.

Two main arguments support Mr Obama's decision to create the FCCCER:

It is difficult to establish comparisons between products that have not been compared in head-to-head clinical trials. Such studies are rare because they are not required by the US FDA for products to be granted marketing authorisations. Furthermore, they present substantial risks to the drug manufacturers who have to pay for them. Bristol-Myers Squibb's PROVE-IT trial comes to mind.

Clinical trial data provide evidence in selected populations under experimental conditions ("internal validity") that might not reflect the true benefit of products under usual conditions of clinical practice ("external validity"). Pragmatic studies are expected to include a larger patient population to allow a combination of interventions and to reflect usual practice. They are expected to help patients and prescribers to select the most appropriate drug for individual cases.

Four research areas may generate data to allow comparative effectiveness studies: large-scale pragmatic trials, the use of databases, new quantitative methodologies and the design of complex quantitative models. No single area is favoured, although it is likely that large-scale pragmatic trials will capture most of the budget.

Yet many large clinical trials have failed to significantly affect medical practice. We can cite the following government-sponsored trials as examples:

CATIE, a National Institute of Mental Health (NIMH) trial in more than 1,400 patients comparing newer atypical antipsychotics with each other and with a conventional antipsychotic for the treatment of schizophrenia;

ALLHAT, the largest-ever antihypertensive trial and the second-largest lipid-lowering trial, with more than 42,000 patients enrolled; and

STAR-D, a seven-year NIMH trial aiming to define strategies to address treatment-resistant depression after failure to respond to a standard trial of treatment with an antidepressant medication.

The impact of these studies on actual clinical practice is debatable. One year after the CATIE results were published, 82% of clinicians treating schizophrenia indicated that they were unfamiliar with the results or that the results had not led them to change their clinical practice.⁴

In the two years following the publication of ALLHAT, the use of thiazide-type diuretics rose from 30.6% of the eligible population (uncomplicated hypertensive patients) to 39.4%, before falling back to 36.5% of patients.⁵ While the improvement was statistically significant, it remains far below the estimated total population that could benefit from such treatment.

STAR-D, meanwhile, did not provide conclusive results to alter medical practice.⁶ Thus large-scale trials are controversial, with debatable results and sometimes marginal impacts.

Following lobbying from the drug and medical devices industries, the Obama administration has clarified the potential use of comparative effectiveness research on reimbursement. The official conference report related to the bill specifies that lawmakers do not intend research to be used to mandate coverage and reimbursement policies for private or public payers.⁷ This makes real impact of comparative effectiveness research on pricing and reimbursement even less likely.
It would have been more effective to use taxes to provide an incentive for the development of Bayesian mixed-treatment comparisons and "complex systems" theory, applied to the field of public health sciences.

Bayesian comparisons can effectively address the lack of head-to-head comparisons between drugs. This well validated and recognised methodology remains underexploited in healthcare decision-making. Bayesian analyses can be used to make rapid and inexpensive comparisons that rank the effectiveness of alternative treatment options for a given indication. Furthermore, use of the technique will encourage the pharmaceutical industry to generate its own direct head-to-head evidence early in the drug development process.

Complex system analysis is already widely used in the physical sciences, meteorology, behavioural sciences and economics. Health outcomes and healthcare definitely obey the definition of complex systems, a new field of science that studies how the different parts of a system give rise to its collective behaviours, and how the system interacts with its environment. It is not possible to capture the actual outcome of a health intervention without integrating all the variables that contribute to it, such as healthcare policies, patient behaviour, the services offered, the societal attitude toward the disease and the insurance coverage. Such variables are currently treated as confounding factors whereas they are in fact an integrated part of the observed outcome.

New mathematical methods to support decision-making for complex systems have been developed, but they remain rarely used in public health. None of the most frequently used statistical methodologies, including propensity scoring (adjusting for differences in population sampling or confounding variables), addresses the complex system field in healthcare.

Clustering the assessment of the effectiveness of drugs assumes that the various health outcome components of an intervention can be analysed in isolation and that they are simply cumulative. Simultaneous analysis of all the factors that drive drug-related outcomes requires the use of complex systems sciences. This is the only way to support proper decision-making.

The cost of an indirect comparison performed by a consulting company ranges from $200,000 to $300,000. Such indirect comparisons are already used by European health technology assessment agencies, such as NICE in the UK.⁸ Investing $500,000 in complex system analysis would allow significant progress in analysing through different methodologies the results of studies already available. A lot of information that has already been generated and stored in data warehouses could be subject to this new analysis and would certainly yield new insights and deliver new benefits.

Without channelling effort into promoting these new methodologies it is likely that tax spending will continue to feed large and expensive pragmatic studies that bring little valuable information to support clear decision-making. Instead, alternative cost-effective methodologies should be encouraged through incentives for the development of comparative effectiveness. This would require a change of paradigm in drug effectiveness assessment. Yet this might well be the true challenge for the FCCCER if it wants to make best use of both the millions allocated to it and the historic opportunity to place comparative effectiveness research on the agenda of the life sciences sector.

References

6. S Hatcher. 'The STAR*D trial: the 300 lb gorilla is in the room, but does it block all the light?' Evidence-Based Mental Health, 11 (4), 97-99 DOI: 10.1136/ebmh.11.4.97, 2008

Professor Mondher Toumi is the chair of market access at the University of Lyon, France, and founder and president of Creativ-Ceutical, a strategic pricing and market access consultancy. Email: mondher.toumi@univ-lyon1.fr.
  Read More & Comment...

Revisiting the Dorgan Organ

06/09/2009 09:39 PM |

WASHINGTON (Reuters) - A U.S. senator on Monday said he dropped plans to try to add a measure allowing importation of lower-priced medicines from other countries to tobacco legislation after being told the Senate will consider the drug issue separately.

Democratic Senator Byron Dorgan said that Majority Leader Harry Reid had promised to bring the drug importation measure to a Senate vote "very soon." Dorgan said he expected the vote to happen within "a matter of a couple weeks."

  Read More & Comment...

Teddy Bares

06/09/2009 05:49 PM |

From www.keithhennessey.com ...

Over the weekend a draft of Senator Kennedy’s (D-MA) health care bill leaked.  After playing with Adobe Acrobat, here is the text of the draft Kennedy bill as a text file (173 K), and as a single Acrobat file (3.4 MB). Unlike the leaked version, both of these are searchable.

Calling it the “Kennedy” bill is something of an overstatement.  Senator Kennedy chairs the Senate Health, Education, Labor, and Pensions committee, and his staff wrote the draft.  By all reports, however, Chairman Kennedy’s health is preventing him from being heavily involved in the drafting.  Senator Reid has designated Senator Chris Dodd (D-CT) to supervise the process, but as best I can tell, it’s really the Kennedy committee staff who are making most of the key decisions.  For now I will call it the Kennedy-Dodd bill.

As the committee staff emphasized to the press after the leak, this is an interim draft.  I assume things will move around over the next several weeks as discussions among Senators and their staffs continue.  This is therefore far from a final product, but it provides a useful insight into current thinking among some key Senate Democrats.

Update:  I now have a three-page outline of the House Democrats’ health care bill.  I have a new post which contains all of the content below, and compares it to the House bill.  If you read the new post, you’ll get two for the price of one: Understanding the House Democrats’ [and Kennedy-Dodd] health care bill[s].

Here are 15 things to know about the draft Kennedy-Dodd health bill. 

1. The Kennedy-Dodd bill would create an individual mandate requiring you to buy a “qualified” health insurance plan, as defined by the government.  If you don’t have “qualified” health insurance for a given month, you will pay a new Federal tax.  Incredibly, the amount and structure of this new tax is left to the discretion of the Secretaries of Treasury and Health and Human Services (HHS), whose only guidance is “to establish the minimum practicable amount that can accomplish the goal of enhancing participation in qualifying coverage (as so defined).”  The new Medical Advisory Council (see #3D) could exempt classes of people from this new tax.  To avoid this tax, you would have to report your health insurance information for each month of the prior year to the Secretary of HHS, along with “any such other information as the Secretary may prescribe.”
2.  
3. The bill would also create an employer mandate.  Employers would have to offer insurance to their employees.  Employers would have to pay at least a certain percentage (TBD) of the premium, and at least a certain dollar amount (TBD).  Any employer that did not would pay a new tax.  Again, the amount and structure of the tax is left to the discretion of the Secretaries of Treasury and HHS.  Small employers (TBD) would be exempt.
4.  
5. In the Kennedy-Dodd bill, the government would define a qualified plan:
6.  
   1. All health insurance would be required to have guaranteed issue and renewal, modified community rating, no exclusions for pre-existing conditions, no lifetime or annual limits on benefits, and family policies would have to cover “children” up to age 26.
   2.  
   3. A qualified plan would have to meet one of three levels of standardized cost-sharing defined by the government, “gold, silver, and bronze.”  Details TBD.
   4.  
   5. Plans would be required to cover a list of preventive services approved by the Federal government.
   6.  
   7. A qualified plan would have to cover “essential health benefits,” as defined by a new Medical Advisory Council (MAC), appointed by the Secretary of Health and Human Services.  The MAC would determine what items and services are “essential benefits.”  The MAC would have to include items and services in at least the following categories:  ambulatory patient services, emergency services, hospitalization, maternity and new born care, medical and surgical, mental health, prescription drugs, rehab and lab services, preventive/wellness services, pediatric services, and anything else the MAC thought appropriate.
   8.  
   9. The MAC would also define what “affordable and available coverage” is for different income levels, affecting who has to pay the tax if they don’t buy health insurance.  The MAC’s rules would go into effect unless Congress passed a joint resolution (under a fast-track process) to turn them off.
   10.  
7. Health insurance plans could not charge higher premiums for risky behaviors:  “Such rate shall not vary by health status-related factors, … or any other factor not described in paragraph (1).”  Smokers, drinkers, drug users, and those in terrible physical shape would all have their premiums subsidized by the healthy.
8.  
9. Guaranteed issue and renewal combined with modified community rating would dramatically increase premiums for the overwhelming majority of those Americans who now have private health insurance.  New Jersey is the best example of health insurance mandates gone wild.  In the name of protecting their citizens, premiums are extremely high to cover the cross-subsidization of those who are uninsurable.
10.  
11. The bill would expand Medicaid to cover everyone up to 150% of poverty, with the Federal government paying all incremental costs (no State share).  This means adding childless adults with income below 150% of the poverty line.
12.  
13. People from 150% of poverty up to 500% (!!) would get their health insurance subsidized (on a sliding scale).  If this were in effect in 2009, a family of four with income of $110,000 would get a small subsidy.  The bill does not indicate the source of funds to finance these subsidies.
14.  
15. People in high cost areas (e.g., New York City, Boston, South Florida, Chicago, Los Angeles) would get much bigger subsidies than those in low cost areas (e.g., much of the rest of the country, especially in rural areas).  The subsidies are calculated as a percentage of the “reference premium,” which is determined based on the cost of plans sold in that particular geographic area
16.  
17. There would be a “public plan option” of health insurance offered by the federal government.  In this new government health plan, the federal government would pay health care providers Medicare rates + 10%.  The +10% is clearly intended to attract short-term legislative support from medical providers.  I hope they are not so naive that they think that differential would last.
18.  
19. Group health plans with 250 or fewer members would be prohibited from self-insuring.  ERISA would only be for big businesses.
20.  
21. States would have to set up “gateways” (health insurance exchanges) to market only qualified health insurance plans.  If they don’t, the Feds will set up a gateway for them.
22.  
23. Health insurance plans in existence before the law would not have to meet the new insurance standards.  This creates a weird bifurcated system and means you would (probably) be subject to a different set of rules when you change jobs.
24.  
25. The bill does not specify what spending will be cut or what taxes will be raised to pay for the increased spending.  That is presumably for the Finance Committee to determine, since it’s their jurisdiction.
26.  
27. The bill defines an “eligible individual” as “a citizen or national of the United States or an alien lawfully admitted to the United States for permanent residence or an alien lawfully present in the United States.”
28.  
29. The bill would create a new pot of money for state gateways to pay “navigators” to educate people about the new bill, distribute information about health plans, and help people enroll.  Navigators receiving federal funds “may include … unions, …” 

This would have severe effects on the more than 100 million Americans who have private health insurance today:

• The government would mandate not only that you must buy health insurance, but what health insurance counts as “qualifying.”

• Health insurance premiums would rise as a result of the law, meaning lower wages.
  
• A government-appointed board would determine what items and services are “essential benefits” that your qualifying plan must cover.
  
• You would find a tremendous new disincentive to switch jobs, because your new health insurance may be subject to the new rules and would therefore be significantly more expensive.

• Those who keep themselves healthy would be subsidizing premiums for those with risky or unhealthy behaviors.
  

• Far more than half of all Americans would be eligible for subsidies, but we have not yet been told who would pay the bill.
  

• The Secretaries of Treasury and HHS would have unlimited discretion to impose new taxes on individuals and employers who do not comply with the new mandates.
  

• The Secretary of HHS could mandate that you provide him or her with “any such other information as [he/she] may prescribe.”

  Read More & Comment...

A Commonality of Interest

06/09/2009 11:44 AM |

The American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) have adopted a new policy regarding the disclosure of conflicts of interest.

Here’s the key paragraph:

“There is no inherent conflict of interest in the working relationships of physicians with industry and government.  Rather, there is a commonality of interest that is healthy, desirable, and beneficial.  The collaborative relationship among physicians, government, and industry has resulted in many medical advancements and improved health outcomes.”

What a unique perspective -- a "commonality" rather than a "conflict" of interest.

Bravo.

The complete AACE/ACE position statement can be found here.

  Read More & Comment...

Is Avandia Safe? Depends on Your Opinion of the Facts

06/08/2009 08:28 PM |

Some people will not take "yes" for an answer....

The results of the RECORD study would seem to vindicate the use of Avandia as a treatment option for diabetes patients seeking to maintain glycemic control and reduce the risk of death from cardiovascular disease....

RECORD: No overall increase in CV risk with rosiglitazone
Adverse findings include increased risk for fracture in women, heart failure
Posted on June 6, 2009

American Diabetes Association's 69th Scientific Sessions

Rosiglitazone was not associated with an increased risk for overall cardiovascular morbidity or mortality compared with standard glucose-lowering therapies, according to the final analysis data of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study.

At 5.5 years, the primary outcome – first occurrence of CV death or hospitalization – was equivalent (14.5%) in patients assigned to rosiglitazone (Avandia, GlaxoSmithKline) or metformin and sulfonylurea, according to Philip D. Home, DM, DPhil, chairman of the RECORD Steering Committee and professor of diabetes medicine at Newcastle University, UK. The researchers reported 321 events among patients assigned rosiglitazone as add-on therapy and 323 events among patients assigned metformin or sulfonylurea only (HR=0.99; 95% CI, 0.85-1.16).

“Overall, in CV terms, the drug is safe. Would rosiglitazone meet current FDA criteria as a safe drug in diabetes? The answer to that is yes,” Home said during a press conference on Friday.

The RECORD study was designed to evaluate the long-term effect of rosiglitazone on CV outcomes and blood glucose control compared with metformin and sulfonylureas. The open-label study was conducted at 338 centers in 23 countries in Europe, Australia and New Zealand. The researchers randomly assigned 4,447 patients with type 2 diabetes who were already on metformin or sulfonylurea monotherapy to either add-on rosiglitazone (n=2,220) or a combination of metformin and sulfonylurea (n=2,227). All doses were progressively increased toward achieving and maintaining a target HbA1c of <7%. If HbA1c rose to 8.5% or more, either a third oral glucose-lowering drug was added (for rosiglitazone group) or insulin was started (for active control group).

Click here to read the full article.

So How do we explain this headline?

RECORD results: rosiglitazone doubles risk of heart failure, fractures
Publish date: Jun 6, 2009
By: Maude L. Campbell, Clinical Managing Editor

The much-anticipated results of the Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes (RECORD) trial seem destined to become yet another element in the agent’s controversial history.

Although rosiglitazone did not increase overall cardiovascular hospitalizations or deaths compared with metformin and sulfonylurea, the risk of heart failure doubled among patients taking rosiglitazone, and there were increased heart failure deaths, reports Philip D. Home, DM, chairman of the RECORD steering committee and Professor of Diabetes Medicine, Newcastle University, UK (pictured above).

And another point. Steve Nissen admitted, in the face of the RECORD evidence, that his initial meta-analysis might be inaccurate…

There were too few incidences of myocardial infarction and MI death among RECORD patients to detect a significant association with rosiglitazone. "I agree with the authors," says Steven Nissen, MD, chairman, Department of Cardiovascular Medicine, Cleveland Clinic. "The results of RECORD are inconclusive with respect to the effects of the drug on the risk of heart attack."

Dr. Nissen points out, however, that in the subgroup of RECORD patients with preexisting heart disease, there was a 26% increase (p=0.055) in MI.

Click here to read the full article.

I should point out, however, that Nissen’s meta-analysis swept everyone who used Avandia into his data pool to get his increase of risk (43 percent). Of course 26 percent is less than 43 percent.

Meanwhile, what havoc and public health impact was caused by the fearmongering…?

  Read More & Comment...

The Bankruptcy Myth: Of Conservative Definitions and Middle Class Debtors

06/08/2009 02:53 PM |

  Read More & Comment...

Reimporting Dumbness

06/05/2009 07:36 PM |

Let's see... new drug development is at an all time low and the FDA is faced with new responsiblities in tracking the safety of generics being produced from China, counterfeit products, tainted goods, the possiblity of developing new standards for follow on biologics...all in the name of safety. 

So the reasonable thing to do is...make it harder for the FDA to track a flood of products from other countries with shady track records?

Of course. Which is why drug reimportation has been reintroduced. Since Congress doesn't  really care about drug safety -- except when it comes to hearings -- the legislation designed to make it legal to tranship adulterated and counterfeit drugs through Canada and Europe (read the bill)  is now attached to a piece of legislation that would give the FDA the authority to regulate tobacco. (Just what we need, FDA approved Cuban cigars stinking up America.)

See this link to the In Vivo blog about drug running and get the whole story...


  Read More & Comment...

Which Drug, Not What Price

06/05/2009 03:10 PM |

In an era of personalized medicine we can and must do better than just shoving people into taking the cheapest drug and then seeing if people slip in convulsions. Ultimately many more drugs are going to to go generic so treatment selection will still be an issue and so will the attendant costs.

NOT WHAT THE DOCTOR ORDERED
The Detroit Free Press
By Patricia Anstett 6/5/2009 5:30 AM

Busy with other chores, Kathryn Pauley asked her 16-year-old to pick up younger daughter Cheyenne 's seizure medicine at a pharmacy.

To her surprise, Pauley found a generic drug, not Lamictal, a brand-name drug that had effectively controlled most of Cheyenne 's seizures. In the next week, Cheyenne , 11, had 21 seizures -- many more than usual.

The switch occurred even though Cheyenne 's doctor had written "dispense as written," or DAW, on the prescription. Cheyenne 's Medicaid policy refused to fill the prescription until her doctor challenged it, said Pauley of Belleville.

A fierce legislative campaign is playing out in Michigan and other states over generic substitution and therapeutic switching, a practice that allows health insurers to fill a prescription with drugs similar to brand-name drugs.

Usually, a doctor can stop a switch by writing DAW on a prescription. But problems still can occur and appeals are time-consuming.

James McCurtis, a spokesman for Michigan 's Medicaid program, said the state prefers to use money-saving generics when possible. Doctors can apply through a process called prior authorization to get a brand-name drug for a patient, but McCurtis acknowledged that process may be time-consuming.

The Michigan Osteopathic Association and the Michigan Association of Family Physicians want changes to ensure consumers are alerted about prescription changes. Health plans and the Michigan Pharmacists Association see any new laws as unnecessary. Either way, there are important issues for consumers to understand.

Mich. fight over generics heats up

The push to use generic drugs has brought big savings to U.S. health care -- $734 billion over the last decade.

But as much as they support ways to hold down health costs, the 7,000-member Michigan Osteopathic Association and the 3,000-member Michigan Association of Family Physicians have some worries. They're concerned that the preference by many health plans toward generics and nearly-equivalent drugs called therapeutic substitutes leave too many patients and their doctors out of the decision-making about which drug they can prescribe or use.

They want state laws to ban payments and other incentives that health plans and pharmacy benefit management companies use to encourage doctors to prescribe generics and so-called therapeutic equivalents -- drugs like but not identical to brand-name drugs.

Another bill would require a patient's consent before a pharmacy could switch a brand-name epilepsy drug to another drug.

Popularity of generics

The issue is significant as more health plans promote generic drugs and Americans look for savings, particularly as they lose insurance or face higher out-of-pocket co-pays. Generic use has risen from 61% in 2006 to nearly 70% today, according to the Generic Pharmaceuticals Association, in a May report.

"Physicians feel they are being handcuffed more and more," said Dr. Craig Magnatta, president of the Michigan Osteopathic Association.

The osteopathic association has produced a printable, wallet-sized card on its Web site to help patients learn about the issue at

www.michigando.com

Every day, Magnatta, a family practice physician with offices in Rochester Hills and Oxford , and one of his assistants plow through a pile of paperwork with insurance company denials or questions about drugs he prescribed.

Many plans won't pay for many brand-name drugs, at least not initially. Health plans particularly make it difficult to prescribe certain drugs, such as epilepsy medicines, antidepressants, blood thinners, proton pump inhibitors, psychiatric, thyroid, pain and antirejection medicines, he said.

Two bills that address generic issues await action later this year by the Senate Health Policy Committee, which postponed a hearing in May. Committee chair, Sen. Thomas George, R-Kalamazoo, said the bills may be reworked.

Unnecessary action?

Michigan 's health plans and the Michigan Pharmacists Association consider the legislation unnecessary.

Dr. Tom Simmer, senior vice president and chief medical officer of Blue Cross Blue Shield of Michigan, said generics have produced sizeable savings, including as much as $1,000 a year for consumers, at a time when many have no insurance or higher drug co-pays.

Nationwide, generics have saved consumers $734 billion over the last 10 years, according to a report issued in May by the Generic Pharmaceutical Association.

"We're saying, before you jump to the $120 a month antacid, try less costly ones," Simmer said.

As more drugs go generic, brand-name drug manufacturers are spending millions of dollars on direct-to-consumer advertising campaigns that inflate health costs by encouraging consumers to ask their doctors to prescribe brand-name drugs, Simmer said.

Antonio Petitta, vice president of pharmacy care management for the Health Alliance Plan, said he thinks the legislation will add red tape.

"It adds a layer of difficulty to prescribing," she said.

Trouble with epilepsy

Arlene Gorelick, executive director of the Michigan Epilepsy Foundation, which favors the bills, said her group and its national foundation are tracking increased incidence of seizures in people who have had to change to generics and therapeutic equivalents.

"Antiepileptic drugs are very precise and establish a delicate balance for each individual with epilepsy," Gorelick added. "No two medications are alike. Even slight changes can cause ... seizures."

Others point out that groups like the Epilepsy Foundation receive funding from brand-name drugs, a fact Gorelick acknowledges but said did not influence the organization's position on the issue.

"The Epilepsy Foundation of Michigan does receive unrestricted educational grants from pharmaceutical companies and device makers, as well as from hospitals and insurance companies," Gorelick said. "These dollars represent a small percentage of our operating budget."

Bringing down costs

Dr. Rick Smith, president of the Michigan State Medical Society, an 11,000-member physician's organization affiliated with the American Medical Association, said his organization has not taken a position on the bills.

Smith said electronic or E-prescribing systems make it easier to track which drugs health plans pay for or prefer to use first and cut out some of the red tape. He was an early user of generics and electronic medical systems in the Henry Ford Health System, where he's an obstetrician/gynecologist.

Generics are "one of the best ways to bring excessive costs down." But he agrees some drugs such as seizure medicines may not be easily substituted, as the therapeutic range of those and some other drugs is narrower, he said.

Additional Facts Drug legislation

Two bills in the Legislature, supported by two state physician organizations and some patient support groups, address generic substitution and therapeutic switching.

# SB 318 prohibits health plans from making payments or giving other incentives to doctors and other health professional to prescribe certain drugs. It also would require Michigan 's attorney general to report quarterly on any payments or incentives that might be viewed as inducements to prescribe a certain drug.

# HB 4408 bans substitution of brand name epilepsy drugs without the consent of the doctor, patient or legal guardian.  Read More & Comment...

The Bankruptcy Myth: Of Credit Card Debt and Medical Bills

06/05/2009 02:28 PM |

You can read the article for yourself here.

Along with the critique by Dranove and Millenson here.

  Read More & Comment...

Obamaceuticals

06/05/2009 01:08 PM |

Excellent omnibus article on healthcare in the Age of Obama in this month’s edition of PharmaVoice.  It’s titled, “Obamaceuticals” and can be found here.

It covers a myriad of important and timely issues (comparative effectiveness, FDA reform, reimbursement strategies, follow-on biologics, etc.). And one nonsense topic – drug importation.

And since, courtesy of Senator Dorgan and friends, we once again must address this sideshow issue, herewith how I was quoted in this article on this topic:

Mr. Pitts wants to make one thing perfectly clear: “First of all, there is no such thing as drug re-importation.” “The term is a political one that is factually incorrect,” he says. “Re-importation implies that drugs that have already been approved by the FDA are being moved out of the United States and sold back in. In its current use, the term refers to the practice of allowing drugs from other countries that have less regulatory control to be sold to U.S. patients. That is drug importation. “For example, in Great Britain 20% of drugs are parallel traded with Portugal, Greece, Latvia, in other words, countries that don’t have as robust a regulatory regime as the United Kingdom, the United States, or even Canada,” he adds. “The drugs a patient gets from an Internet U.K. pharmacy are not legal in Canada, let alone the United States. Patients are led to believe they are getting the same drug and they are not.” Reports show that drug importation would reduce drug prices over 10 years by less than 0.1%, Mr. Pitts says. “Importation is a great sound bite, but at the end of the day, it has serious safety considerations and doesn’t save a bit of money,” he says. “I don’t think HHS Secretary Sebelius would ever say these drugs are safe and put her signature on a bill that does.”

That last sentence refers specifically to the issue of Secretarial Certification (not in Senator Dorgan’s amendment, but in thoughtful language offered by Senator Cochran and others).

Okay, once more into the abyss -- when it comes to drug importation, there is no there there when it comes to savings – but  there are serious safety implications.

The there that is there is that drug importation is a direct path to price controls.

Should drug safety (not to mention intellectual property rights) be sacrificed at this dubious altar? 

  Read More & Comment...

Mr. Layton Goes to Washington

06/05/2009 12:44 AM |

  Read More & Comment...