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.

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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.
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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."

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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.”

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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.

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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…?

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The Bankruptcy Myth: Of Conservative Definitions and Middle Class Debtors

06/08/2009 02:53 PM |

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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...


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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.

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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? 

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Mr. Layton Goes to Washington

06/05/2009 12:44 AM |

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Healthcare Musings

06/04/2009 09:25 PM |

Sorry if this is TMI -- I have a hernia.

I went to the doctor today and he says to me, "What do you do?"

I answer, "Healthcare policy."

He responds, "So you don't need to do any heavy lifting."

I wince.

And here's the punchline --  my hernia will be operated on by Dr. Lo.

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Success through Failure

06/04/2009 07:30 PM |

Pfizer tries new uses for failed drugs

By Gail Appleson

ST. LOUIS POST-DISPATCH

When scientists at Pfizer's Sandwich research facility in England began studying a compound called Sildenafil, they thought it showed promise as a treatment for high blood pressure and angina.

However, when early clinical trials were conducted, the results suggested the drug wasn't sufficiently effective for its intended use. But it did work amazingly well for something else. It caused penile erections. So Pfizer decided to market the compound as Viagra and, in 1998, the drug made history as the first oral treatment approved to treat erectile dysfunction in the United States.

The tremendous success of this pharmaceutical recycling effort is far from lost on Pfizer, the world's largest drug maker. About two years ago, it formed a research group to find alternative uses for compounds that don't work as intended. The 50 scientists in the group also try to find other opportunities for drugs in their early development stage.

The Indications Discovery Unit has a new home in the recently opened $200 million research building on the Pfizer Global Research and Development campus in Chesterfield. The new building allowed Pfizer to consolidate its Missouri-based research and development into a single location. About 1,000 Pfizer scientists conduct drug discovery research in Missouri.

Donald Frail, chief scientific officer of the Indications Discovery Unit and director of Pfizer's St. Louis laboratories, said that finding additional uses for pharmaceuticals is important because it can take 10 to 15 years for a drug to get approved, and few in development ever get that far.

Most drugs must go through three phases of human testing. The first round is to make sure the compounds are safe. The second and third test whether the drugs are effective for their intended use. Frail said more than 75 percent of drugs in development never make it past Phase II of testing.

"It's a daunting job," Frail said about being a drug researcher. "It's a minority of scientists that see their drugs get to market."

Frail said Pfizer now focuses on six principal areas: oncology, inflammation, neuroscience, diabetes, cardiovascular and pain. Scientists in the Indications Discovery Unit look for other applications both within and outside those areas.

"The hunt is pretty fascinating," he said. "We let the compounds lead us to the patient. Our playing field is preset by the molecules."

An example of a drug being examined for other uses is Pfizer's Sutent, which is on the market for use against kidney and stomach cancer.

Pfizer has been testing it for other uses as well, and in March the company said Sutent showed "significant benefit" in patients with a form of pancreatic tumor.

But the research on the drug doesn't stop there.

"We're looking at it now for a different, totally nononcology application," Frail said.

Although most drugs never get regulatory approval, the possibility of finding a successful treatment or cure continues to drive researchers in their quest, Frail said.

"It's easy to be motivated when there are patients in need out there," he said.

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The Noxious Weed of Drug Importation

06/03/2009 02:16 PM |

Lots of talk about the FDA's transparency initiative.  That's good. 

Lots of gossip about the FDA supporting a codicil in pending tobacco legislation that would legalize drug importation.  That's bad.

And remember, there's no such thing as drug "reimportation." That's putting lipstick on a pig.  This isn't about making available to Americans the "same" drugs being sold to our neighbors to the north.  This is about drugs from a multitude of nations (most notably those of the European Union).  That means a drug that is said to come "from Great Britain" could just as easily originate from places such as Greece, Portugal, Latvia, or Malta. And basic economics dictates that goods from lower cost markets flow into higher cost ones. (In fact, more than 20% of all prescription medicines sold in the UK are "parallel imported" from lower cost nations within the EU.) These drugs, arbitraged through Canadian internet pharmacies and then resold to Americans may be dubbed "reimported" but that's just plain misleading -- because these off-the-back-of-the-truck medicines are not even legal for sale in Canada.  So much for "the same drugs" as you can buy at a pharmacy in Toronto.

How can an FDA that wants to more robustly promote drug safety (and appropriately so) also support the importation of foreign drugs into the United States?  It's bad enough when some of our elected officials choose to put rhetoric and politics in front of the public health -- it's something else entirely when such an attitude is adopted by the agency responsible for pharmacovigilance.

The career staff at FDA has consistently been against drug importation, so wither the switcheroo?  Politics has no place in FDA decision making. And the last time I looked, the same career staff are in place.  Draw your own conclusions.

In the spirit of transparency:  what is the FDA's position on drug importation?
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Tamiflurry Part Deux

06/02/2009 08:56 AM |

Where's Senator Grassley when you need him?

Last week we wrote about “Tamiflurry.”

A brief recap:

On May 4-5 the Harvard Business School Health Alumni Association along with the Young Presidents Organization/World Presidents' Organization (YPO/WPO) sponsored a conference in Washington, DC, "Health Reform at the Intersection of Government and Markets.”  After two days of robust debate and discussion over a wide range of issues, the event ended with a troubling episode.

So troubling, in fact, that one physician in attendance along with another independent businessman felt obligated to write to Randy Cohen, who pens “The Ethicist” column at the New York Times, with the following query:

“We were attending a conference on health reform which had included an impromptu presentation on the swine flu pandemic.  As the conference was closing, a physician was introduced and he said that as a “treat” for all his fellow attendees he would write prescriptions for TAMIFLU and that if he ran out of scripts, he would send one to anyone who emailed him a request.  A large line immediately formed of people eager to avoid the risk of shortages or rationing.  When confronted with our question as to the ethics and legality of his offer, he explained that he was a physician and had worked with the CDC and was confident he was acting in a morally and professionally correct manner – was he?  For that matter, were the conference organizers in ethically troubling territory?”

The full post can be found here.

Our post was directed at Dan Brock, the Director of the Harvard University Program in Ethics and Health.

Herewith (and with permission) is Dr. Brock’s response:

“If your description of what transpired is accurate, then the action of offering an Rx for Tamiflu to all the attendees at this meeting was in my view clearly unethical, and essentially for the reasons you and Randy Cohen cite. Physicians should not be writing prescriptions for persons who are not their patients, nor should they be encouraging others to stockpile a potentially scarce drug. Why the organizers of this event permitted it I have no idea, nor do I know who they were.

You ask what can I do about this. The answer is probably not much, and that is not because I do not believe that what you describe as transpiring was not wrong. But neither of the two ethics programs at Harvard that I direct put them or me in the role of "ethics police" for everything that goes on connected with Harvard Medical School. The obvious parties with whom a complaint should initially be lodged are the organizers of the event who apparently permitted this to go on at the meeting.

If the physician offering the prescriptions was a member of the Harvard Medical School faculty then a complaint could also be lodged with the medical school. HMS has procedures for responding to allegations of faculty misconduct, but neither I nor my programs are involved in that process. I agree that an investigation of the matter is appropriate and one or both of these parties should be in a position to do so.”

Senator Grassley – how about an investigation?

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The Brownlee-Lenzer Effect: Fearmongering's Death Toll

06/01/2009 10:02 PM |

Depression Treatment Wanes Following FDA Warnings

Advisories led to 'unintended consequences,' researchers say

By Karen Pallarito
HealthDay Reporter

MONDAY, June 1 (HealthDay News) -- Newly diagnosed cases of depression in America have dropped sharply since the government's warning of an increased risk of suicidal behavior among children and teens taking antidepressants, a new analysis finds.

Read more here

Peter and I, among others, were attacked for pointing out that hijacking of science surrounding the risks of antidepressants would lead to public health problems including an increase in suicide. In particular Shannon Brownlee and Jeanne Lenzer unleashed an ad hominem attack on both of us and Dr. Fred Goodwin that resulted in a witch hunt on Goodwin's reputation.  Meanwhile the pseudo-scientific biases of Brownlee and Lenzer about the use of SSRIs in particular --  Brownlee claims that  biochemically, "the drugs might trigger suicide and bipolar disorder" --  and asserts that there is no biological link between serotonin and depression (Scientology claptrap) or that doctors do not know which patients will respond to which meds (see the STAR-D trial for that) were used to fuel an attack not on the merits of the position but on funding sources.  

Well, facts are stubborn things, particularly in biology where observation is...well, as Groucho Marx used to say, "who do you believe? Me or your eyes?" Scaremongering by Brownlee and Lenzer, combined with the witchhunt against shrinks who received pharma money allows those who "know" despite the data that SSRIs are a holocaust in waiting to dominate both the media and the mainstream medical journals who feed on each other.  

And meanwhile the connective tissue between patient and doctor is shredded by fear. The public health suffers. People get sicker.  They kill themselves. 

Perhaps the relationship between industry and academia needs or needed a shakeup to focus more on risks and benefits. Industry deserves blame for not staying ahead of the curve on many of these issues and responding in a more timely fashion to potential problems. But the Brownlee and Lenzer school have an ideological approach to medicine: industry corrupts all it touches and it buries its pollution (the risks of its products) as a matter of policy. Much like the anti-vaccine groupies, in the face of mounting evidence they are wrong they find new excuses to remain unconvinced and unpersuaded.

We have seen the damage of their approach. They are partly responsible for promoting the decline in treatment and are responsible for the consequences. 
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Health Care Costs Abroad –Take Two

06/01/2009 03:39 PM |

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Tevi Mettle

06/01/2009 11:49 AM |

Former HHS DepSec Tevi Troy has an important article in the June edition of Commentary, "The End of Medical Miracles?"

Here's how it begins:

"AMERICANS HAVE, at best, a love-hate relationship with the life-sciences industry—the term for the sector of the economy that produces pharmaceuticals, biologics (like vaccines), and medical devices. These days, the mere mention of a pharmaceutical manufacturer seems to elicit gut-level hostility. Journalists, operating from a bias against industry that goes as far back as the work of Upton Sinclair in the early years of the 20th century, treat companies from AstraZeneca to Wyeth as rapacious factories billowing forth nothing but profit. At the same time, Americans are adamant about the need for access to the newest cures and therapies and expect new cures and therapies to emerge for their every ailment—all of which result from work done primarily by these very same companies whose profits make possible the research that allows for such breakthroughs."

During the course of his article, Troy discusses the issues that threaten to derail medical progress (litigation, an overly cautious FDA and, of course, legislation to put Uncle Sam in charge of our healthcare).  Troy concludes:

"Just as there is potential danger from the way in which Americans take the power of the antibiotic for granted, so, too, one of the greatest threats to our health and continued welfare is that Americans in the present day, and particularly their leaders, are taking for granted the power, potency, and progress flowing from life-saving medical innovations. And in so doing, they may unknowingly prevent the kind of advance that could contribute as vitally to the welfare of the 21st century as the discovery of the antibiotic altered the course of human history for the better in the century just concluded."

Tevi's complete article can be found here.

All the rest is, well, commentary.

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Dear John

05/29/2009 11:59 AM |

Lately we’ve been discussing the issue of taxing employer-based healthcare benefits in order to finance Uncle Sam’s career change to Uncle Sam, MD.

We talked about it here:

“The Vast Reich Wing Conspiracy”

And here:

“Pink Cadillac”

And now we welcome the Wall Street Journal to the debate. Here’s what they had to say on this today:

 

Taxing Health Care
Obama and Democrats owe John McCain an apology.

Politicians wouldn't be politicians if they didn't trim their sails to the prevailing winds. Even so, the emerging 180-degree turn by Democrats on taxes and health insurance is one for the record books.

Democrats have spent years arguing that proposals to equalize the tax treatment of health insurance are an outrage against the American people. Workers pay no income or payroll taxes on the value of job-based plans, but the same hand isn't extended to individuals who must buy coverage on their own. Last year liberals mauled John McCain for daring to touch the employer-based exclusion to finance more coverage for the individually uninsured. He was proposing "a multitrillion-dollar tax hike -- the largest middle-class tax hike in history," said Barack Obama, whose TV ads were brutal.

But now Democrats need the money to finance $1.2 trillion or more for their new health insurance entitlement. Last week Senate Finance Chairman Max Baucus released his revenue "policy options" and high on the list is . . . taxing health benefits. Or listen to White House budget director Peter Orszag, who recently told CNN's John King that the exclusion "was not in the President's campaign plan, it wasn't in our budget. Clearly, some Members of Congress are putting it on the table and we are going to have to let this play out."

Mr. King tried again. "Let this play out. But would the President sign a bill that includes a pretty significant tax increase? That would be a tax increase." Mr. Orszag: "We're not going to be -- I think it's premature to be commenting on individual items . . . There are lots of ideas that are being put on the table." Translation: You betcha he'd sign it.

The tax exclusion is such a big revenue prize because Mr. Baucus is scrubbing every other tax nook and cranny and only coming up with rounding errors. A sampler:

- Impose an excise tax on hard alcohol, beer and some kinds of wine. That would be in addition to a sin tax on beverages sweetened with sugar or high-fructose corn syrup, such as soda. Mr. Baucus doesn't offer revenue estimates, though the Congressional Budget Office says a $16 per proof gallon alcohol tax might raise $60 billion over 10 years, and another $50.4 billion at three cents per 12 ounces of sugary drink.

- End or limit the tax-exempt status of charitable hospitals, which only costs currently a mere $6 billion a year.

- Make college students in work-study programs subject to the payroll tax. Also targeted are medical residents, perhaps on the principle that they'll one day be "rich" doctors. CBO has no score on these.

- Reducing Medicare reimbursement rates for supposedly "over valued physician services," such as diagnostic imaging. CBO says that requiring doctors to get prior clearance could save $1 billion in 10 years.

- For individuals with high-deductible insurance plans, contributions to health savings accounts would no longer be tax deductible. That would penalize patients who choose plans that encourage them to be informed consumers. CBO says that banning HSA payments entirely would yield all of $10 billion.

By contrast, the employer-based exclusion offers a huge money pot -- an estimated $226 billion in 2008. Yet as liberal MIT economist Jonathan Gruber recently told Mr. Baucus's committee, "no health expert today would ever set up a health system with such an enormous tax subsidy to a particular form of insurance" (his emphasis). It creates a coverage gap between workers who receive it from their employers and those who pay -- or can't afford to pay -- with after-tax money.

The tax exclusion is also one reason health costs continue to rise. It encourages workers to take an extra dollar of compensation in fringe benefits instead of cash while also routing low-deductible health spending through third parties. Some 84 cents of every medical dollar is spent by someone other than the patient. The insured have no incentives to make cost-conscious decisions about care.

So reforming the exclusion would inject a dose of discipline into American medicine. But for most Democrats the goal isn't to create a more rational health-insurance market. They simply want the revenue for another government program. Mr. Baucus won't target gold-plated employer insurance plans in general, because union-negotiated benefits are usually gold-plated. Rather, he may cap or phase out the exclusion by income, starting with workers earning more than $200,000. Insurance options that don't conform to government diktats (health savings accounts) would also lose any tax advantage. This would do nothing for market efficiency, but it would be one more stealth tax increase.

Democrats owe an apology to Mr. McCain, and it'll be fascinating to see if they will now suffer a political backlash of their own making. Having told the country that this tax reform is really a tax increase, Democrats are opening themselves to the same attacks they leveled against Republicans.

They could avoid that fate if they used the tax exclusion money to finance, say, a tax credit for the uninsured. That would be a genuinely bipartisan reform. But liberals won't accept that because they want to take one giant step toward government-run health care. And the only way they can pay for it is by taxing everything in sight, including your current health insurance.

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