Latest Drugwonks' Blog

While one New York Times article reported on Eliot Spitzer bloviating that, if he is elected governor, research on stem cells and other promising treatments would be the “centerpiece” of the state’s health care policy (I sure hope access is up there too), another article, by Andrew Pollack, reported on a truly important issue — genetic diagnostics.

It’s worth reading. Here’s the link:

http://www.nytimes.com/2006/04/13/business/13diagnose.html

Mitt Happens

  • 04.13.2006

The always incisive Grace-Marie Turner (of the Galen Institute) points out some uncomfortable truths about Governor Romney’s universal health insurance program:

Proceed with Caution

The new Massachusetts health plan has dominated the policy conversation over the past week, causing more division among conservatives than liberals.

The law, designed to make the state the first in the nation to achieve universal health coverage, was signed on Wednesday by Gov. Mitt Romney. He was flanked at the invitation-only ceremony by the Democratic leaders of the Massachusetts legislature and by Sen. Ted Kennedy, a long-time advocate of universal health coverage.

The biggest concern among conservatives is the requirement that every individual in the state must purchase health insurance or face financial penalties.

Mandates are almost impossible to enforce, even with the fines and other enforcement provisions in the law. Further, the state must specify what kind of insurance people are required to buy and how much they should pay, taking away the ability of markets to freely compete and for people to purchase the coverage of their choice.

We were also concerned about the back-door employer mandate. The legislature wanted to force employers with 11 or more employees to pay a $295 annual fine for any employee without health insurance. The Governor vetoed the provision, but leaders of the heavily Democratic House and Senate have said they will override.

House Speaker Salvatore DiMasi called the veto disingenuous, saying the law was crafted with concessions and compromise. “To change anything will disturb the delicate balance that made this law possible,” DiMasi said. Note to employers: $295 is only the beginning.

While many conservative groups, like the Pacific Research Institute, the Cato Institute, and the Council for Affordable Health Insurance, have been highly critical of the plan, The Heritage Foundation has been very involved in helping the Governor craft the legislation. The Governor credits Heritage with creating the new FEHBP—ike insurance connector to offer insurance options and collect and distribute premiums. Bob Moffit of Heritage stood behind the Governor at the signing ceremony.

An integral provision is the requirement that every employer with more than 10 employees — think your local automotive garage — must offer a Section 125 cafeteria plan so employees can use pre-tax money for their insurance premium contributions.

And that’s only the beginning of the reporting requirement, mandates, penalties, and other enforcement provisions in the new law, for example:

* The law requires every employer and employee in the state to sign “under oath” a Health Insurance Responsibility Disclosure form, testifying to whether the employer has offered insurance and whether the employee has accepted or declined.

* It creates at least 10 new boards and commissions to create and run the new health system, such as the Health Care Quality and Cost Council, the Payment Policy Advisory Board, and the Health Access Bureau.

* New and existing state agencies will be checking on individuals’ insurance status, monitoring their income to see if they qualify for subsidies, and tracking individual health habits (like smoking and wellness activities) to determine their insurance rating category.

* There also is a major expansion of Medicaid and S-CHIP to cover children up to 300% of poverty, and the state makes it clear that it is doing all it can to maximize collection of federal matching funds to help finance the new plan.

My biggest concern is over the financing. The state says it is just moving money around — redirecting about $1 billion in uncompensated care money to subsidize health insurance for those under 300% of poverty (about $50,000 a year for a family of four).

But there is nothing in the law to keep health insurance costs from soaring. Policies offered through the new health insurance Connector must have first dollar coverage and include all of the 40 coverage mandates on the books, with none of the provisions that are working in the private sector to engage consumers as partners in managing health costs. Estimated premiums are unrealistically low and will quickly lead to higher taxes and “assessments” on individuals and employers.

Nonetheless, newspapers around the country are falling over each other in their effusive praise of a Blue state, led by a Republican governor, building a bridge across the political chasm to go where no other state has gone before.

Gov. Romney’s term ends this year, and he is likely to be spending a lot more time in Iowa and New Hampshire than in Massachusetts as this plan gets up and running. But I worry that he has laid the foundation for what can become a very intrusive, onerous, and expensive health plan for Massachusetts. Other states, which are firing up their Xerox machines now, should wait to see how this works out before rushing to follow the Bay State’s lead.

When it comes to empowering patients to play a more important role in their own health care, our mostly free-market confreres from across the Atlantic can learn from both our failures and our successes — but first they have to stop being afraid of the “A” word. That’s “A” like in “advertising” of the direct-to-consumer kind.

Have a look at the attached op-ed from today’s European edition of the Wall Street Journal.

Download file

Got Science?

  • 04.11.2006

If a pharmaceutical company funds a double-blind clinical trial performed by highly respected medical researchers, are the results relevant?

Not necessarily.

Click below to find out the rest of the story.

http://www.chicagosuntimes.com/output/otherviews/cst-edt-ref11.html

Does anyone take Sid Wolfe and Public Citizen seriously anymore? In a pathetic attempt to block the OTC marketing of fat-blocking drug Xenical, Sid and his group — who peddle a scare a day screed called “Worst Pills, Best Pills” as a Christmas gift — are actually arguing that the drug should be pulled because…….the drug allegedly caused precancerous colon lesions in animal studies!!! Sid Vicious forget to mention the mounting evidence that Xenical exhibits antitumor properties towards prostate and breast cancer cells by virtue of its ability to block the lipogenic activity of fatty acid synthase. Oh. I guess bumps in a rat’s rump are more compelling than the ability to block cancer to the good folks at Public Citizen. What dopes.

Why is this week different from all other weeks? Well, it’s Passover for one thing but moreover BIO is meeting in Chicago where plenary sessions are discussion some very critical questions about whether, when personalized medicine matures, government regulators, trial attorneys, and the pols won’t suffocate in pursuit of their own agendas. Cases in point:

The Agency for Health Care Quality and Research — under orders from Congress — is supposed to compare the cost-effectiveness of certain drugs and treatments. (This is a Hillary Clinton pet project.) Bad enough that every day more and more research comes in for specific subgroups that AHQR isn’t looking at. Medical knowledge is not just doubling it is transforming as molecular diagnostics will help tailor preventive strategies for care to the individual or specific pathway. And what if reimbursement decisions are made based on these head to head studies while ignoring genetic variations? I can see a system where people are dying or sicker than they should be under Hillarycare’s new manifestation because it’s cheaper to simply rule on the old data and ignore the new.

What about a federal prosecutor or HHS that makes it a crime to tell patients about novel uses for medicines that are apparent at the molecular or biomarker level but not aproved by the FDA? Does that make sense? Where is the safe harbor for companies? The fact is, docs and researches and patients are already way ahead of the bureaucrats and lawyers in the effort to match targeted treatments to high responders. BUt will the threat of litigation and the refusal to pay for these treatments slow down progress?

Finally, the Critical Path opportunities list has been launched. We need a new commissioner to drive change through the agency and to create momentum for change throughout the regulatory system. The agency needs more resources to retain and hire talented and dedicated scientists to bring about this change and it needs to be involved in the development of the scientific consensus required for such an effort. Technological and societal change requires leadership. Requlations that stifle it will will not fall without such efforts.

Let’s call it like it is, the canard of evidence-based medicine is one-size-fits-all medicine. At its core it is cost-based rather than patient-based.

According to Greg Scandlen of the Heartland Institute, the concept of evidence-based medicine is founded on a few key ideas:

* First is that there is too much variation in medical practice, and variation is a bad thing. We should know what to do and do it in all cases, the idea goes. Medicine should be standardized around what is known to work.

(Of course this also presupposes that all people respond precisely the same way to all medicines. Sure. And if you believe that one, let me introduce you to my pet rabbit Harvey.)

As Mark McClellan said, “Looking at a gigantic uniform solution for everything is never going to work. (JD Kleinke, Health Affairs, May/June 2004; 23(3): 177-185.)

* Next, there is only one way to determine what works and what doesn’t — using randomized, double-blind studies and measuring the effects on large populations to develop guidelines and practice protocols.

(I suppose that, after all, without our traditions our lives would be as shaky as … a fiddler on the roof!)

* Third, physicians who fail to follow those guidelines should be punished.

Scandlen opines, “Under this scenario, the only room for debate is around the severity of the punishment. People have argued that noncompliant physicians should be paid less, have higher premiums for malpractice coverage, lose their hospital privileges, be kicked out of insurance networks, and/or have their medical licenses revoked. I haven’t yet heard anyone argue that noncompliant doctors should be thrown in jail, but it is only a matter of time.”

Indeed. Perhaps this will encourage Consumer Reports to move beyond offering “best buys” on medications for Alzheimer’s Disease (see blog “Crash-Test Dummy Medicine,” 3/6/06) to legal advice on how to sue physicians for practicing patient-based medicine.

(Sadly, I’ll bet the folks at Consumer Reports don’t find this concept so outrageous.)

One-size-fits-all medicine may provide transitory savings in the short term, but the same patient who takes the cheapest available statin today may very well be the patient costing you — the taxpayer — the policymaker — the thought-leader — the sister — the spouse — big bucks when that patient (otherwise known as a “person”) ends up in the hospital because of improperly treated CVD.

And make no mistake, by “improperly treated” I mean treated with the least expensive rather than the most effective medication.

The reprecussions of short-term thinking vs long-term results, of cost-based over patient-based, of one-size-fits-all medicine, is pernicious to both the public purse and the public health.

Bye NCI. G'Day FDA.

  • 04.07.2006

For those out there who think that Andy von Eschenbach isn’t serious about his job at the FDA or question the Administration’s desire for his Senate confirmation, today’s news that he is officially resigning his post at the NCI should provide cause for reflection.

You may have missed many of these facts. I’m sorry, that’s wrong. What I meant to say is that you probably haven’t read about these facts.

So, without further ado, here’s some Sunny-D.

* Enrollment So Far Has Almost Surpassed The Entire Year’s Goal.

27.6 million of the 42.4 million eligible seniors are now covered by the prescription drug benefit. Of the 14.8 million who are not enrolled, 5.8 million are covered by alternative drug benefits like Veterans’ Administration or their current employers. (CMS, 3/23/06)

* Enrollment Is Well Ahead Of Schedule.

The benefit has now almost met its goal of enrolling 28 million seniors by December 2006. (CMS, 3/23/06)

* More Seniors Are Enrolling Every Week.

Since the start of March, seniors have been enrolling in the plan at an average rate of 416,000 per week, and enrollment has increased 29 percent since February. (CMS)

* A Majority Of Seniors Approve Of The Plan.

79 percent of seniors approve of the drug benefit, and 50 percent approve “strongly.” (Harris, 2/7-2/9/06)

* And Seniors Who Haven’t Yet Enrolled Plan To.

47 percent of seniors who aren’t yet in the plan say they plan to enroll by May 15; an additional 16 percent said they would sign up soon when reminded that costs will be higher after then. (KRC Research, 3/15-3/20)

4 Out Of 5 Seniors Who Signed Up For The Plan Are Satisfied.

78 percent are now satisfied with their prescription drug coverage, while just 13 percent are not. Furthermore, 77 percent now say they have peace of mind about their coverage and 67 percent say they’re better off than they were before. (KRC Research, 3/15-3/20)

* The Longer They’re In The Plan, The More Positive Seniors Feel About It.

66 percent of seniors say the effort they put into evaluating different drug plans was worth it, while only 13 percent say it wasn’t. The number who says it was worth it has increased by a net of 12 points since December 2005, when 57 percent thought it was worthwhile and 16 percent disagreed. (Ayres McHenry, 3/6-3/9/06)

* Seniors Have Been Using The Plan Successfully.

84 percent of seniors who enrolled themselves in the plan had no troubles signing up and 85 percent had no problems using it. (Ayres McHenry, 3/6-3/9/06)

* Seniors Are Able To Choose The Plan Right For Them.

Almost three-quarters of those in the plan, 72 percent, are confident they chose the drug plan that best fit their needs. (Pew Research, 3/8-3/12)

* Seniors In The Plan Are Saving Money On Their Drugs.

The average senior in the plan will save more than $1,100 on their prescription drugs this year. Furthermore, the plan’s premiums now average $25 per month, down from a projected $37 per month. (CMS Final Rule Regulatory
Impact Analysis, 1/28/05)

* And They Would Recommend It To Others.

65 percent of those in the plan say they would recommend other seniors enroll; just 8 percent said they would not. (Ayres McHenry, 3/6-3/9/06)

* Seniors Think The Plan Is A Step In The Right Direction.

Two-thirds of seniors, 66 percent, believe the drug benefit was a step in the right direction, while just 20 percent think it was not. (KRC Research, 3/15-3/20)

* And They Believe The Benefit’s Critics Are Playing Politics.

46 percent of seniors in the plan believe that politicians criticizing the prescription drug benefit are just trying to score political points, while only 14 percent think they are sincerely trying to fix it. (Ayres McHenry, 3/6-3/9/06)

It’s D-Lovely.

Romney Redux

  • 04.05.2006

The bi-partisan health care bill passed by the Mass. legislature requires deadbeats who don’t get health insurance only to ask taxpayers to foot the bill of their uncompensated care to the tune of three quarters of billion a year (more than Manny Ramirez makes ) to buy their own insurance. It gives people help to buy insurance on sliding scale according to income. The money comes from the uncompensated care fund most states have to pay for folks to use health care but don’t have or pay for insurance. It expands HSAs, allows consumes and small businesses to purchase health insurance at the same rate as big corporations through association health plans, relies on competition based on price and quality to drive down costs. These are all principles pushed by President Bush.

And by the way, the Mass. bill was applauded by my good friend Ron Pollack of FUSA. Now the question is: if market-based competition is good enough to expand coverage for the 65 and under crowd, why does Godfather Ron oppose the same principles when applied to Medicare?

Here’s a link to a powerpoint presentation of the Mass. plan elements

http://www.hcfama.org/_uploads/documents/live/Conference%20Committee%20House%20PowerPoint.pdf

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.

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