Latest Drugwonks' Blog

Is it recess yet?

  • 07.30.2009

The Wall Street Journal reports, “Declining popularity of the health-care overhaul reflects rising anxiety over the federal budget deficit and congressional debate over the most contentious aspects of the legislation, including how to pay for it. The poll also shows concern over the role of government in determining personal medical decisions.”

The New York Times reports, “President Obama’s ability to shape the debate on health care appears to be eroding as opponents aggressively portray his overhaul plan as a government takeover that could limit Americans’ ability to choose their doctors and course of treatment.”

Translation:  Americans are really concerned that healthcare reform has moved from the “first principle” of  providing insurance to the uninsured to a big power grab that would turn Uncle Sam into Uncle Sam, MD.

And concern is most definitely warranted.

Nowhere is this more important then when it comes to the issue of comparative effectiveness.  Current legislative drafts generally refer to “clinical effectiveness” – a more appropriate term.  But, when you peel back to onion what most pro-big government advocates mean is “cost effectiveness.”  These terms are not (nor should they be) interchangeable.

For more on this issue, have a look at the Reuters “Great Debate page.  The relevant article is, “In determining healthcare cost, one size doesn’t fit all.”

America is waking up.  It’s going to be a long, hot summer.

I have always been a big fan of the Fiercemarkets suite of publications as the one of the best collection of industry news stories on the Web, bar none. 

The editors dedication to doing so is evident even when their support of the "public option" doesn't square with the news the provide readers... as in this delicious morsel of cognitive dissonance from editor Anne Zieger...



Establishing a government-run public health plan to compete with private health plans may be a great idea, or the model may truly be rife with those nasty "unintended consequences" its opponents like to cite. I simply don't have enough data to tell you whether it's a good idea for the long term.

But what I can tell you is that as a blunt instrument, it seems that analysts are pretty much agreed that a public plan will have the immediate effect the Obama administration is hoping for, which is to drive down private health insurance costs. A new study by Lewin Group is only the most recent to project that a government-run plan would come in with much lower premiums than its private competitors--in its case 20 percent lower. And sure enough, private health plans will have to respond with big price cuts of their own.

True, if you're a financial manager reading this, one of those pesky "unintended consequences" is probably that you'll find that your reimbursements falling. Private health plans are going to pass those price cuts on to you, after all. Hopefully, you'll make up the difference by seeing far more insured patients walk in your doors, a deal that's pretty much on the table under any version of reform, but yes, for the short term you'll be in a scary place. Hopefully, though, the longer-term picture includes a more-stable system that works better for everybody.

Overall, the bottom line is that at present, giving way on a government-option plan is a pointless compromise that wastes not only an enormous amount of Congressional time and effort, but also a unique moment in history when the President, the Congress and the people are agreed that it's worth seeing everyone take some big bruises to fix some of health system's biggest problems.

Namby-pamby half-measures like a health co-op, which, let's face it, still has an incentive to keep its medical expense low so it can grow and attract new members, are feel-good nonsense which do nothing to take advantage of the government's powerful position in the industry. Create health co-ops and you've only added another player to basic capitalist cycle, not-for-profit though it may be.

So I say, come on now, Congressional leaders. Don't pussy-foot around--be honest and forceful about what the government option is intended to do. It's designed to hit the health insurance industry with a clue-by-four and let it know that the time of extreme profit-taking is on its way out. If you can't get that through, so be it, but at least you'll have fought the good fight. Don't let this once-in-a-lifetime chance to save countless Americans' lives and health go away because you refused to take a real stand
. - Anne


Meanwhile there are these stories about the impact of government involvement on "profit taking"... (which will also affect Anne's job no doubt..)

According to a new analysis by The Lewin Group, under a health reform draft currently under consideration by Congress, the number of uninsured Americans would fall dramatically, by about 32. 6 million, and premiums for a "public option" plan would be an average of 20 percent less than private plans for families.

However, things don't look so rosy for providers, the report suggests. Hospitals that accept Medicare and other public plan reimbursements would see cuts that take them down to an average of 32 percent below what private health plans pay. Physicians would see their pay cut by an average of 14 percent below what private insurances pay out for a given treatment, Lewin's analysis concluded.

While Lewin doesn't make a big deal of it, apparently it does support the conclusion that a public plan would put considerable pressure on private plans to lower their premiums, something employers and consumers are likely to favor. However, clearly providers face a real threat here. This data is definitely something to chew on..

Yes indeed, especially since a lot of those private sector providers are in the non-profit sector, and accept a whole bunch of Medicaid and Medicare folks already.   Meanwhile there is this, also in Fiercehealthfinance...

The next few months shouldn't be much better for non-profit hospital systems than the first half of 2009 was, according to a new report from financial ratings firm Standard & Poor's. S&P says that with the recession continuing to grind away at balance sheets and credit market troubles limiting access to cash, systems are continuing to struggle.

The agency reports that median operating margins fell or remained flat for the 134 systems it rates, regardless of their credit rating. Overall, the median operating margin for the group was 2.4 percent, compared with 2.8 percent the prior year.

Net margins, which take into account plunging investment income, fell from 6.3 percent in 2007 to 2.5 percent in 2008. Meanwhile, cash reserves were sapped as health systems used savings for capital investments and pension funds, and to post collateral on interest-rate hedges known as swaps.

As a result of these pressures, health system rating downgrades doubled in 2008, to 18, with S&P lowering the outlook for 27 systems, up from 14 such actions the previous year.

To learn more about the S&P report:

Read this American Medical News 
piece

I am sure all that public reimbursement will make the non-profit situation just namby-pamby....

Good thing Anne has that quality of care and impact on life expectancy and morbidity issue worked too...  particularly among the chronically ill seniors, poor minorities and low birth weight neonates... but maybe that's just the namby-pamby in me...  

At least Zieger is honest: a government takeover of health is a blunt instrument: price controls and rationing.  

Now I am wondering if she was being sarcastic or serious?  

Read more here


 


Switches Brew

  • 07.29.2009

Permit me to share some personal information – my eldest son has epilepsy.  The good news is that his condition is under control due to the wonders of modern medicine.  For that reason, today’s Good Morning America segment on generic drug substitution (minus patient and physician knowledge or consent) hit a particularly resonant chord.

Here’s how GMA began its report:

"Imagine going to the pharmacy to fill your prescription only to learn later that the drug your doctor prescribed is not the one you received. The prescription was switched without your knowledge or permission. SharePharmacies could be switching your drugs without your knowledge. Not just switched to a generic version of the prescribed drug, but to a different drug altogether. That is exactly what happened to Amy Detrick, who said her pharmacist switched her epilepsy medication without her permission.”

The report also interviews Sally Greenberg, executive director of the National Consumers League, "We believe that if a patient is switched from one drug to another, that it should not be legal unless the patient and the doctor have been informed and are on board with the switch."

(The complete Good Morning America segment can be found
here.)

In October 2008, National Consumers League released a survey of 1,035 prescription drug users on therapeutic substitution issues this morning.  The survey was conducted by Harris Interactive.  Full results and additional materials are online at www.nclnet.org/health/switching/ and the press release is at http://www.nclnet.org/news/2008/therapeutic_substitution_10012008.htm.    

Key data points include:

Patients Surveyed Want Transparency about Therapeutic Switching

  • Respondents very much oppose health insurance companies providing incentives to pharmacists (55%) or physicians (55%) for switching patients to lower cost alternatives to medications.
  • Vast majorities of respondents (78%) very much favor an explicit requirement to consult the physician before any and all therapeutic substitution takes place.
  • Vast majorities of respondents (85%) very much favor a requirement that patients always be notified if their prescription is changed.
  • A large majority of the general population are not sure if there is a law in their state that regulates therapeutic substitution (90% of the Rx users), but 50% of Rx users somewhat or very much favor legislation. 


Patient Awareness of Therapeutic Switching is Low, but Patients Believe it is Happening

  • As expected, awareness of the concept of therapeutic substitution – and the difference with generic substitution – is low.

        2 of 3 prescription users are unaware therapeutic substitution

        Only 1 in 4 prescription users are unaware that therapeutic substitution involves replacing the prescribed drug with a chemically different one

  • The vast majority of Rx users think that therapeutic substitution occurs at least sometimes in the US (84%), without informing the patient (68%) or the prescribing physician (59%).


Switching Doesn’t Always Result in Positive Outcomes

  • 15% of general Rx users saying that they or a family member experienced therapeutic substitution

        Nearly half of Rx users (47%) were dissatisfied (or their family was) with how the process occurred and report that this substitution did not result in lower pocket costs.

        More than a third (40%) said that the new medication was not as effective as the original one, and nearly a third (30%) experienced more side-effects following the substitution.

        Large majorities of Rx users think that the potential side effects of the new medication, the patient’s medical history, how well the drug works and the prescribing physician's opinion are factors that are absolutely essential when decisions are made about therapeutic substitution.


Just as no two patients have the same biochemistry, no two medicines are exactly equivalent.  But if your primary goal is to reduce short-term costs, that's an inconvenient truth.

I am a big believer in FDA-approved generic drugs. They are safe and effective and represent an enormous opportunity for health care savings. I applaud insurance company programs that seek to educate consumers about them. However, I am a bigger opponent of forced switching. Disempowering physicians and patients results in bad outcomes.

The repercussions of choosing short-term thinking over long-term results, of short-term cost-based choices over patient-based care, of “me-too” medicines over the right medicine for the right patient at the right time—are pernicious to both the public purse as well as the public health.

According to the Pink Sheet:

“The Obama administration's proposal to establish an executive branch advisory council on Medicare payment issues may raise the threat of government negotiations for Medicare Part D drug prices. The legislative proposal was forwarded to House Speaker Nancy Pelosi July 17 by Office of Management and Budget Director Peter Orszag, who urged that some form of an Independent Medicare Advisory Commission be included in House health reform legislation.”

“Leaders of the House Energy and Commerce committee have agreed to incorporate the concept in the Tri-Committee health reform bill, committee Chair Henry Waxman, D-Calif., announced July 22. The concept is supported by the fiscally conservative Blue Dog Democratic coalition in the House, which has emerged as a key factor in moving the bill.”

“The White House proposal would establish IMAC to take on some of the Medicare payment and coverage decisions now handled by Congress - mainly payment rates under the Part B physicians' benefit as well as Part A, which pertains to inpatient hospital care. However, the group would also be authorized to recommend other Medicare payment reforms and the Part D prescription drug program is explicitly discussed in the document.”

“For the most part, where specific aspects of Part D are mentioned, they are described as areas where IMAC is not authorized to make recommendations. The document includes a section entitled "exclusions," stating "the council may not recommend any changes to the following aspects of the Medicare program" and listing about a dozen Part D citations. The intent of the exclusions section is to list the sections of the law ‘with which the Council's reform recommendations must remain consistent.’ "

“On closer look, the exclusion list has an interesting exception: "noninterference in 1860D-11(i)" of the Social Security Act.The noninterference clause in 1860D-11(i) has been in the crosshairs for Democratic lawmakers since the Part D program was established. It says the HHS Secretary ‘(1) may not interfere with the negotiations between drug manufacturers and pharmacies and PDP sponsors; and (2) may not require a particular formulary or institute a price structure for the reimbursement of covered part D drugs.’ “

“By excepting the clause from the list of ‘exclusions,’ the proposal can be read as allowing IMAC to reopen the issue, Sidley Austin partner William Sarraille agrees. It also shows that policymakers continue to pursue ways for the government to use its strength at the Part D bargaining table, he pointed out. ‘The Democrats are determined to get government negotiation,’ he said.”

Talk about Part D Deficit Disorder.

Many suggest that allowing the feds to directly negotiate for Part D is no different from the current VA scenario. But suggesting that the Veteran’s Administration “negotiates” prices for prescription drugs is a false premise.  

Under rules set by Congress, to sell drugs to the VA, companies must offer each drug at a price that “represents the same discount off a drug’s list price that the manufacturer offers its most-favored nonfederal customer under comparable terms and conditions.” The medication must be offered “at a discount of at least 24 percent off [the] nonfederal average manufacturer price (NFAMP). An excess inflation rebate is also required, equal to the percentage by which the price increase for [the] drug has exceeded the consumer price index (CPI) in the prior period.” The manufacturer must make all of its drugs available through the Federal Service Schedule for any of its drugs to be eligible for reimbursement under the VA and Defense Department health systems, the Public Health Service (including the Indian Health Service), the Coast Guard, and the various state Medicaid programs.

A study by Professor Frank Lichtenberg of Columbia University found that the majority of the VA formulary’s drugs are more than eight years old and more than 40 percent are 16 years old or more. Just 19 percent of all prescription drugs approved by the FDA since 2000 are available to veterans; only 38 percent approved during the 1990s are.

There’s a big difference between negotiating and mandating – and it’s not a thin line. My fear is that a government negotiated Part D plan is but the first step towards a more strident program of government price controls.

(And remember, the Non-Interference Clause was originally authored by Senators Kennedy and Daschle.)

Harry & Louise 2.0

  • 07.27.2009

Remember Harry & Louise?  Well welcome Harry & Louise 2.0.  And this time they’re for healthcare reform.

As Ad Age reports:

Harry and Louise's job description is dramatically different today than it was in the 1990s. During the Clinton administration, all they had to do was poke holes in a complex government plan -- something TV advertising lends itself to. This time around, the characters must use the medium to build support for a complex government plan.

Former FDA Associate Commissioner Peter Pitts, now the president for the Center for Medicine in the Public Interest, said he doesn't think the ads are going to do much to help Mr. Obama's cause.

"What's important to remember is that nobody -- not insurance companies, not drugmakers, not doctors, not patients, not politicians -- disagrees that reform is needed," Mr. Pitts said. "That said, 2009 is very different from the initial iteration of Harry and Louise. The average television viewer and YouTube viewer is much more sophisticated and much more aware that these are two paid actors. They were paid 16 years ago to be against health-care reform, and now they're being paid this year to be for health-care reform. If they were paid tomorrow to be New York Yankees fans, you would see a commercial for that."

The complete article can be found here.

And, speaking of the NY Yankees -- Happy Birthday to A-Rod.

Following Obama's press conference claim that reimbursing for nutrition might be more cost effective than treating disease,  Psycho Donuts will be reimbursed at the government rate under the public plan as a provider of mental health services.... 









http://www.psycho-donuts.com/home/

Deadbeat Dutch

  • 07.24.2009
After completing yesterday’s post on noncompliance with health insurance mandates in other countries, I ran across updated statistics from Statistics Netherlands on the number of people there who aren’t paying their premiums, even though they signed up for a health care package.
 
Statistics on defaulters in 2008, put the number of Dutch over 18 who have failed to pay their insurance bills at 280,000, 16 percent more than the previous year and up from 190,000 in 2006. This group constitutes 2.2 percent of the adult population. Men have made up most of the rise in defaulters.
 
The year 2008 saw 108,000 new defaulters, probably in part because of the economic crisis, with 63 percent being men. But perhaps the most shocking number is how many people have been in default since the new health care system went into effect – in 2006. Over 95 thousand Dutch have shirked their premiums for a full three years, and yet are still considered to be insured. I think we can all agree that it is absurd to allow people who have defaulted on their obligations to remain on the insurance roles or to enroll with a new insurance company.
 
Default rates in the Netherlands vary considerably by ethnic background, however, with 14.6 percent of Antilleans and Arubans in default in 2008 vs. 1.6 percent for Native Dutch. In total, about 60 percent of people who have not paid their premiums are Native Dutch, a share that has remained steady.
 
A similar trend is observed when you look at people in the Netherlands who have not signed up for insurance at all, despite the fact that it is mandatory. Of those with foreign background, 3.6 percent are uninsured vs. a mere 0.4 percent of Native Dutch. The majority of those with no coverage were in their twenties and thirties.
 
 

Magic's Hook

  • 07.24.2009

Will DDMAC’s July 14th warning letter to Abbott  send shivers down the spines of MLRers, reinforcing the notion that the FDA doesn’t approve of the use of celebrities?

Let’s look at the facts:

DDMAC cites Abbott’s promotional DVD, titled "I Know What's Important," for clumping the risk information in a dull section of at the end of the video and suggesting that Kaletra (lopinavir/ritonavir) has broader utility in treatment-experienced patients than the label supports.  The “I” is non other than Ervin “Magic” Johnson.

In the Kaletra DVD, the first 111/2 minutes are devoted to an "engaging and lively" discussion with Johnson about the benefits he has experienced from the drug. "In contrast," DDMAC writes, "the presentation of serious risks associated with Kaletra is relegated to the end of DVD after the interview is over, where it is unlikely to draw the viewer's attention, and is displayed as a running telescript."

The only risk information included during the interview is a brief acknowledgement by Johnson that he experiences "fatigue sometimes" and disclosures in SUPERs that Kaletra "is not a cure for HIV infection," that "the most commonly reported side effects of moderate severity that are thought to be drug-related are: abdominal pain, abnormal bowel movements, diarrhea, feeling weak/tired, headache, and nausea, " and that "children taking KALETRA may sometimes get a skin rash."

DDMAC argues that while Johnson's claims may be an accurate reflection of his own experience, "inclusion of the SUPER stating 'Individual results may vary' ... does not mitigate the misleading impression created by the promotional DVD that all or most treatment-experienced patients taking Kaletra can expect to survive and be healthy for at least five years."

"FDA is not aware of substantial evidence or substantial clinical experience to support effectiveness for five or more years of treatment with Kaletra in treatment-experienced adults," DDMAC wrote, and the "personal experience of a Kaletra patient such as Magic Johnson does not constitute such evidence."

"These claims misleadingly overstate the efficacy of Kaletra by suggesting that the usual outcome of treatment with Kaletra is the preservation and continuance of a 'normal life,' including activities of daily living, work productivity, and social, emotional, and physical functioning," DDMAC wrote.

Note: No claims were made to infer that use of  Kaletra helps to enhance one’s baby sky hook.

Yes I Hate Medicaid

  • 07.24.2009
Watch the unraveling of the liberal mind. Yes, they can't believe there are individuals who do not systematically confuse expanding entitlements with concern with individual health or in the case of Igor, who equates forcing poor people to stay in Medicaid with "access" or keeping the healthcare or doctor you have.

"This morning on MSNBC, Igor Volsky, the Wonk Room’s health care blogger and co-author of Howard Dean’s Prescription for Real Health Care Reform, defended President Obama’s health care proposal. When host Chris Jansing argued that the Congressional Budget Office is predicting that health care reform would “increase long-term costs facing the government,” Igor noted that the CBO released a statement last night stating that the House bill would be deficit-neutral.

Igor debated Robert Goldberg, the president of the industry-funded Center for Medicine in the Public Interest. Towards the end of the segment, Goldberg attacked Igor, saying, “I can’t believe I’m hearing a liberal think tank support systematically restricting minorities from access to quality care.” Igor noted that “no one is restricting minorities, Robert — what are you talking about?” Goldberg revealed that his real problem is that he hates Medicaid:

GOLDBERG: If you’re a Medicaid recipient, you are not allowed to take a voucher and go to a plan that you think is good for you. You are forced to stay into Medicaid. Do you think that’s right or wrong? Yes or no?

IGOR: I think Medicaid provides essential services for many Americans that the private market simply can’t provide, which is why we’re expanding Medicaid. … It’s not putting people into Medicaid against their will."

Right, the "private market" can't provide... maybe because the rules and price controls make it impossible for a private market to exist let alone response to unique patterns of care?  Another reason I hate Medicaid, along with the fact that under Obamacare it will subsidize rich and healthy people...

Igor also noted that the motive behind including a public health insurance option for all Americans is to ensure everyone is given access to a solid benefits plan regardless of their income or class.

Watch it:

I provide the link since the site has so  many intelligent comments that follow the original post...


Read more here


CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog