Latest Drugwonks' Blog

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

Lots of discussion today about Governor Mitt Romney’s initiative to provide universal insurance coverage to all residents of Massachusetts. But what’s really unusual is that the debate is over the program rather than politics. The “tease” from Pam Belluck’s article in today’s edition of the New York Times reads, “Combining ideas from across the political spectrum, the state would be the first to require its citizens to have insurance.” And consider this — the bill was passed by a legislature that is 85 percent Democratic and was hammered out with proposals and input from state Democratic legislators; Mr. Romney, a Republican; Senator Edward M. Kennedy, a Democrat; insurers; academics; businesses; hospitals; and advocates for the poor, including religious leaders.

When pigs fly indeed!

Let the debate begin.

DiMasi Digested

  • 04.05.2006

I recently had the privilege of discussing the future of drug development with CMPI advisory council member, Joseph A. DiMasi, PhD, Director of Economic Analysis Tufts Center for the Study of Drug Development, Tufts University.

Here are some tidbits you may find of interest —

Q: How will 21st century science help advance the future of drug development?

A: There are hopeful signs that new technologies and analytical approaches will improve the pharmaceutical R&D process in the 21st century. If successful, they will reduce costs and facilitate getting the right drugs to the right people at the right time. There is a growing recognition that genetic and other biomarkers that predict efficacy and toxicity responses or measure disease progression need to be developed, validated, standardized and included in drug development programs. The resulting increase in predictive power can eventually permit smaller and more informative clinical trials. Sharing of blinded clinical outcomes data from failed as well as successful trials across companies can also improve the efficiency of the clinical development process. Bioinformatics, data mining, and Bayesian statistical analysis can also help. Given the high costs of investigating the numerous drugs that eventually fail in testing, advances in discovery and preclinical development technologies that result in a higher hit rate for successful drugs can substantially reduce development costs.

Q: Will these advances impact cost?

A: All of the above technologies and techniques can lower the overall cost of drug development. It is hard to know how much they will do so, but reductions of one-quarter or one-third in average costs seem attainable from increases in success rates or reductions in development times.

Q: What can the FDA do to facilitate these improvements?

A: There is much that the FDA can do, in conjunction with industry, academia, and other government agencies, to modernize the development and regulation of new medicines. These include collaborations to develop and validate biomarkers, facilitating the analysis of pooled data on outcomes across clinical trials, developing guidance on how pharmacogenetic data can be used in labeling, how to utilize outcomes data from post-marketing drug surveillance, where and when it is appropriate to use Bayesian analysis and observational studies, and the evaluation of and standards for electronic medical records submissions.

Sound familiar?

As we’ve discussed before — how about a standing FDA advisory committee on communications issues? See attached article from this week’s Pink Sheet.

Download file

Simple but Salient

  • 04.04.2006

It’s not a “stop-the-presses” moment, in truth it’s kind of a “duh,” but here’s a story that crossed the wires today that speaks to, among other things, the power of the FDA’s bully pulpit.

And here’s to more use of it.

AP — Prescription drug prices soften dramatically even with moderate competition, the Food and Drug Administration said Tuesday in an analysis that shows the arrival in the marketplace of just two generic versions of a brand-name medicine can nearly halve the price consumers pay.

When a brand-name drug faces just one generic competitor, that challenger typically sells for 94 percent of the cost of its branded rival. More competition quickly widens that discount: Once a second generic manufacturer appears, the average price of a generic drug drops to just 52 percent of the brand-name version’s cost per dose, according to the analysis posted on the FDA Web site.

Prices continue to tumble, albeit more slowly but almost without exception, as more manufacturers join the market, the analysis shows. By the time nine manufacturers are producing generic versions of a drug, their products typically sell for just 20 percent of the price of the brand-name medicine, according to the federal analysis of 1999-2004 retail sales data on single—ingredient drug products collected by IMS Health Inc.

Jamie Love, who has written and lobbied obsessively about how pharmaceutical IP is the single barrier to making medicines affordable worldwide threw yet another bomb today from his blog at This time, in a broadside tamely entitled “Terrorism Pfizer-Style” Love accuses Pfizer of killing Filipinos by suing to block the illegal production of a generic version of Norvasc, Pfizer’s top selling blood pressure drug.

Norvasc is expensive in the Philippines relative to prices in Pakistan and India for example which have robust — and illegal — generic markets. But the wholesale and retail markup on Norvasc in the Philippines is also nearly 100 percent of the manufacturer price according to the WHO, a fact that Love leaves out in his attack. He also ignores the fact that Pfizer offers a 30 percent discount to people who sign up for their discount plan and does not object to a legitimate licensee making a generic version.

Affordability of medicines is a big problem worldwide. But IP is not the main barrier more often than not. Where it is, companies and countries can come together to work out innovative solutions that protect innovation and limit piracy. Most essential drugs are already generic. Markups, taxes and tariffs matter. And getting medicines to people even when they are free (as inthe case of measles and TB drugs) is often difficult even when the governments are not corrupt or engaged in war. For Love to call Pfizer a terrorist reflects immaturity at the least. At the worst, it reflects a lack of sensitivity to those Filipinos that have been slaughtered by the Abu Sayyaf Group and other militant Islamic groups. Such statements, along with the willingness to ignore all the facts, are yet more reasons to not afford Jamie Love the credibility he constantly craves.

Reinhardt's Ravings

  • 04.03.2006

Uwe Reinhardt is the smartest health care policy expert in the history of the world…just ask Reinhardt and he will tell you so in 5000 words or more. It could be that he is confusing the the fact that he is a speed dial holdover of journalists from the Clntoncare debacle (when the Clintonistas disrespected his genuis to the point that he was good for a quote a minute about how stupid Bill, Hllary and Ira Magaziner were) with being the light unto generations, but who am I to argue? His most recent target of contempt is Al Hubbard, the president’s point man on health care who is pushing an effort to make the price of hospital and physician services transparent. It’s a good idea and was never offered as a panacea but since Uwe didn’t come up with it, he is defining it as simplistic and stupid.

But it takes one to know one. If you really want to see what Uwe is really like, get a load of his rant on the Physicians for a National Health Plan web site written back in 2001. He calls Americans weak, selfish, stupid, childish, dupes en rouote to venting his frustration as to why they won’t accept rationing and a government run health plan. It is a rambling, hyper screed. I have posted the entire rant because it reveals the Left’s contempt of the American character and its rapid hatred of anything that smacks of free choice.


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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