Kidding Us on Uninsured Children

10/22/2008 06:43 PM |

Three percent of all children under the age of 19 lack insurance at some point during the year according to a study release in JAMA this week.

But what do the numbers really say?

"However, the Rochester team found that kids from families with annual incomes at 200 percent to 400 percent of the poverty level ($38,000 to $76,000) are now just as likely to be uninsured as children from poorer families. "

76K and you can't or won't add your kid to your health plan? In NJ, the cost of adding two kids to your individual HMO health plan (and this is the most expensive place in the nation to do so) is $400 a month. Not cheap but still....

Moreover, why can't we provide middle class Americans, single parents, kids starting out, with less expensive health care coverage. Am I missing something? Why not a monthly fee of $100 to cover primary care, prescription drugs and catastrophic health care costs?

Read article here
  Read More & Comment...

Joe The Plumber, Dan The Doctor and the McCain Health Care Plan

10/22/2008 06:26 PM |

When it comes to making the tax system more progressive,  truth be told, no one does more in one fell swoop in that regard than John McCain.

At least that was the point I made at a debate I participated in at Columbia University Medical Center on which health care proposal was better for America: McCain's or Obama's?

According to a report by the Lewin Group, the Obama plan -- which seeks to preserve employer based insurance -- does so by shoving about 52 million Americans into publicly funded health plans.  It pays for that transition by cutting the reimbursement of doctors by at least 25 percent compared to what they get from private insurers, raising about $300 billion in taxes and cutting insurance premiums through price controls.  I ignore the estimated savings from health IT and disease management because it's all based on articles published by people like me.  

In essence, the Obama plan is preserving the tax exclusion for employer based insurance, which favors the rich.  As the Center for Health Transformation's Jim Frogue noted several years ago: "Under the current tax code, workers whose employers contribute to their health coverage have that amount excluded from income and payroll taxes. Most employees are not aware of this (which is why Obama is able to portray the McCain health plan as a tax increase).  Yet it amounts to a significant and, incidentally, highly regressive tax break--the higher one's tax bracket, the bigger the subsidy. According to the Lewin Group, a leading econometrics consulting firm, families earning $100,000 per year average $2,638 in tax subsides, but those under $15,000 get an average subsidy of only $79."
http://www.heritage.org/research/healthcare/EM740.cfm 

26 million Americans will get private coverage under the McCain plan and 12 million of those will be able to shop for health insurance that is cheaper than the $12000 a year policy Obama and Biden believes is the "right" amount of coverage.  And that coverage will be available with guaranteed issue conditions but shorn of expensive mandates that many people who are indifferent to risk but price sensitive do not want. 

Under the McCain plan, as I noted, the amount employers contribute will be counted as wages and will be taxed at the marginal tax rate as Obama notes.  But it will also, as the Lewin study notes, lead to an increase in wages and overall greater tax subsidies overall at every tax bracket with most of the tax subsidies going to Americans in the lowest income brackets.  Of course, those in the higher brackets will be able to bank increased wages in tax free HSAs, IRAs ,etc.  to offset tax liability. 

And under the Obama plan Dan the Doctor will get paid less, pay more taxes and get sued more often and more successfully.  Under McCain, doctors will be able to compete and serve patients directly outside of government controls. 

I think there is considerable openness to other approaches to making health care convenient and affordable in both camps.  At least I hope so.  Because the effort to herd people into a glorified version of SCHIP or Medicaid -- or simply giving everyone an HSA -- will fail. 

  Read More & Comment...

Orszag's Good Behavior

10/21/2008 05:48 PM |

Does  Peter Orzag have a new gold standard for comparative effectiveness:  comparing established treatments like antidepressants to placebos and finding placebos just as effective....
http://www.cbo.gov/doc.cfm?index=9887
Let's take a step back.

In his powerpoint presentation Orszag has a slide stating:

"As we seek to improve the efficiency of the health sector, let’s learn some lessons from economics."

He shows some slides that automatic enrollment in 401Ks leads to higher participation in 401k plans than when it's voluntary.  As if that's an earth shattering discovery.

Then a slide purporting to show that the placebo effect is almost as strong as antidepressants, angina pectoris treatment, knee surgery and exercise. 

Then a slide showing that once a day dosing and frequent doctor-patient interventions increase compliance with medication regimens

What are we to derive from this?

I think Orszag is trying to underscore the importance of psychological and behavioral differences in determining responses to treatment, not that placebos are better. 
That is, individual responses have to be taken into account to maximize value and improve outcomes.  Establishing who is risk averse and why is part of this process.  So too is genetic response to medicine.  All are important. 

That is, measuring the personal is critical to comparative effectiveness.   Finding ways to promote patient-centered care is crucial.  More to the point, perhaps Orszag is seeking to drive comparative effectiveness towards value-based medicine based on personalized health care information which in turn is generated by a critical path for comparative effectiveness. 

Thank  you Dr. Orszag. 
 
  Read More & Comment...

Silence is Leaden

10/21/2008 12:55 PM |

The always savvy Jim Edwards has a thoughtful and important article in this week’s edition of BrandWeek.  Its title, “Why Pharma Fears Social Networking,” says it all.

Almost.

Edwards writes that, “Although a majority of marketers have embraced online social media and user-generated content efforts, one industry is conspicuously not taking advantage of the gold rush: pharmaceuticals.”

His use of the term “gold rush” defines the scope of the article.  He’s talking about Pharma and social networking in terms of marketing and sales.  Well, it is BrandWeek after all. But there's so much more to Pharma and social networking than just marketing.  But I'll get to that in a minute.

Jim continues, “Marketers fear that user-generated content will include complaints about injuries caused by their drugs’ side effects. The law requires these “adverse events” to be reported to the FDA. The FDA’s adverse-event databases are regularly combed by lawyers looking for potential class-action suits. Thus, drug marketers have stuck with a decidedly Web 1.0 model, in which customer interaction is kept to an absolute minimum.”

Indeed.  And what a truly 21^st century malaise it is – being “decidedly Web 1.0” in a 2.0 world.  A digital dilemma if ever there was one -- worse even than restless leg syndrome.

But Edwards believes that, “This head-in-the-sand approach may be about to change. A debate is raging in the drug business as to whether companies should adopt a Web 2.0 strategy. On one side are digital agencies telling companies that online customers generate far fewer adverse event reports than drug companies might expect.  On the other side are brand managers, whose every published word must survive a thicket of in-house lawyers, some of whom aren’t Internet savvy. The pressure for drug companies to evolve is growing.”

And I am quoted as follows:

“Drug companies need to begin embracing ways to look for adverse events instead of hoping they don’t stumble across them. I think the attitude of ‘there’s safety in ignorance,’ or active ignorance, is no longer actionable or responsible.”

Looking for the early adaptor? The BrandWeek article calls out Johnson & Johnson for specific kudos.  

Edwards writes, “One company is attempting to prove it either way: Johnson & Johnson, which in March acquired Childrenwithdiabetes.com, a community site for parents of kids with diabetes. The site has open bulletin boards and even takes ads from competing companies. Joe Natale, vp-new media, said J&J monitors the site for adverse events and people who give incorrect medical advice, but aside from that anyone can post whatever they want. “The best way to destroy that community would be to in any way hamper or infringe upon the way they create content or share information. If [a company thinks] that every post for every user has to be reviewed and copy-cleared in advance, I will tell you not to waste your time.”

Here is the complete BrandWeek article..

There are legal issues – and they’re important.  There are marketing opportunities – and they’re exciting.  But what really matters is that social media is a terrific opportunity to help educate the various constituencies of American healthcare about all sorts of important issues.  Safety?  Sure.  But also safe use, compliance/adherence, and a host of others.

If safety is important (and it is very important), then pharmaceutical companies should seek out (rather than side-step) ways to uncover legitimate adverse events.  By not engaging in 21^st century digital expiscatoriation, industry leaves the FDA with little choice but to pursue its own well meaning (if questionably designed) communications vis-à-vis early safety signals.  Silence is leaden. The obvious lines between social media and traditional DTC are obvious and will be used by legislators and pundits intent on hoisting the industry with its own petard.  Pharma must lead, follow, or get out of the way.  Complaining is not an option.

And neither is avoidance.

  Read More & Comment...

A Potent FDA Double Feature

10/20/2008 02:37 PM |

The Pink Sheet reports that, “FDA’s initiative to influence the safe use of dugs will kick off in the new year.”

According to Dr. Janet Woodcock, “FDA does not control the health care system, so our improving the use of marketed drugs, to a great extent, is going to involve influence rather than control,” by partnering with the growing patient safety movement, she said. “The vast majority of harm from approved drugs comes from misuse, inappropriate use … failure to use, abuse and medical mix-ups. There is just carnage out there, and we know that.”

“Influence rather than control” is a savvy and sophisticated concept -- one that many of our elected members of Congress could learn from.

This new "Safe Use" initiative is the patient-facing sibling of the agency’s “Safety First” pharmacovigilance progam. But it's more than that -- it's the FDA reasserting ownership of safety from those who would use it only as a malllet of fear.

And it’s a potent double feature.
  Read More & Comment...

Healthcare v. Tort Bar

10/20/2008 02:09 PM |

Here is today’s house editorial from the Washington Times:

EDITORIAL: The FDA and junk science
Monday, October 20, 2008

There are many good reasons for the Supreme Court to uphold the authority of the Food and Drug Administration in determining what information should be included on the label describing the risks and benefits of a drug. A current case would challenge that authority, known as pre-emption, and hand it over to trial attorneys suing drug companies that, as part of any financial settlement, would be able to demand changes to the information a company would have to provide doctors and consumers.

Today's Op-Ed by Tomas Philipson notes that vaccine investment dried up after litigation costs in the wake of a successful lawsuit. But higher prices are not the only result of overturning pre-emption. Nor are they the most costly. The litigation that found pertussis vaccines "caused" Sudden Infant Death Syndrome was conducted without any scientific basis for such a link. This has spurred a whole industry of trial attorneys and doctors on the take who have been willing to concoct the conspiracy that vaccines or their ingredients "cause" autism or other brain damage. That in turn has allowed science to be hijacked in favor of what one observer has called "judgments based on anecdotes and speculation."

That observer was Marcia Angell, who, more than a decade ago, saw how fearmongering fed by courtroom antics and junk science shoved aside the FDA and caused a panic among women regarding silicon breast implants. It was a panic, as Dr. Angell noted back then, that had "no good scientific evidence for or against a link between breast implants and systemic disease of any kind."

Today, it is even easier to supplant science and replace it with a state of fear. Fake blogs, journalists working closely with trial attorneys, and doctors and scientists on tort-lawyer payrolls create and spread specious theories and crank out statistical associations without any real evidence of cause and effect. Panic spreads and is reinforced in court-proceedings. As one theory is knocked down, such as the measles vaccine causing autism, another one - thimerosal - springs up.

And you only need one "study" to cause panic and launch a class-action lawsuit. (That and the visceral hatred of corporations Dr. Angell once found to be flimsy basis for silicon-breast-implant litigation.) But now Dr. Angell claims that the courts are the only avenue to establish the real risks of a drug because the FDA is merely a rubber stamp for drug companies. Forget the fact that the number of drug approvals have declined in the past few years and the number of late-stage drug flops has increased. So much for evidence.

Dr. Angell and the current editors of leading medical journals are willing to allow the trial bar to displace the FDA. This group is willing to forfeit the ability to target risk and benefit - where science is heading - and permit opinion and emotion to hold sway. As Dr. Angell noted, in the courtroom, the experts' opinions are the evidence. It would seem now that Dr. Angell and others have drug companies in their sights, their opinion (and overturning pre-emption) is all that matters.

  Read More & Comment...

Prescription Shakedown Litigation Projection

10/20/2008 02:02 PM |

Fred Baron, the tort lawyer who helped write the book on how to attack Merck and Pfizer on COX-2 liability, rolled out heavy hitters in the Democratic party to lobby Biogen to grant him a compassionate use of Tysabri to treat his late stage multiple myeloma.

I hope and pray it works for his sake and everyone else's suffering with the disease including my boyhood friend's mom who has gone through every other drug for the disease but who has now relapsed.

"Biogen Idec is running an early-stage trial of the drug in multiple myeloma, but Baron doesn’t meet the criteria to participate.

Baron’s a prominent donor to the Democratic party, and many of his powerful friends, including Lance Armstrong and Bill Clinton, made appeals on his behalf. And the family agreed not to sue if anything goes wrong."

Gee, why didn't he think of that when it came to Celebrex which generated billions for Pfizer and also had anti-cancer properties that were being studied until Baron's tactics were deployed in lawsuits against the the product: Ironically, Tysabri was yanked from the market in the wake of the Vioxx withdrawal...

Pfizer, the world's biggest drugmaker, has reached a settlement in thousands of cases involving two prescription painkillers." The company announced Friday that "it had agreed to set aside $894 million to settle virtually all the lawsuits related to its withdrawn painkiller Bextra (valdecoxib) as well as a similar drug that remains on the market, Celebrex (celecoxib)," the New York Times (10/18, B2, Saul) added. The agreement "comes approximately one year after Merck announced a $4.85 billion reserve to settle litigation involving the similar painkiller Vioxx (rofecoxib)."

In 2004, Celebrex and Vioxx, "part of a class of drugs called Cox-2 inhibitors," were found "to increase the risk of heart attacks and strokes, especially in patients who took them steadily over long periods of time," the Los Angeles Times (10/20, Healy) notes. And, despite several trials that have shown that Celebrex may "offer a real prospect of preventing cancer," Pfizer "called off a number of clinical trials...and abandoned efforts to have the drug's cancer-prevention qualities recognized by the Food and Drug Administration" after "Vioxx was withdrawn from the market."

 

Note the amount of cash Pfizer had to fork over to various special interests in a decision that had nothing to do with with real risks of the drug, including the Prescription Access Litigation Project which is a limited liability corporation that funds and reports directly to Community Catalyst which also runs The Prescription Project.

"The Pfizer agreements...came after several pre-trial court rulings in the company's favor," according to Amy Schulman, Pfizer's general counsel. In one case, a district judge "who oversaw the federal cases in San Francisco" ruled that "there was insufficient scientific evidence that Celebrex caused heart attacks or strokes at the 200-milligram dose."

There is a certain degree of chutzpah requried to push for the off-label use of a drug to save your life when you have made millions perfecting a strategy employed by an organization that launches lawsuits based on the principle that off-label prescribing is inherently deceptive. I have to say I admire it and would do anything to keep living as well. As I said at the outset, I hope Baron responds and lives a long and healthy life. As for the Prescription Shakedown Project...that's another matter entirely...  Read More & Comment...

The Risk Swamp

10/17/2008 04:53 PM |

 Wither the FDA's Critical Path program?

Last we visited this topic, the Reagan/Udall Center remained mired in political treacle.

Little has changed.

My article in the October edition of The Journal of Medicine and Philosophy, “FDA and the Critical Path to Twenty-first century Medicine,” takes a look at what’s going on – and has already generated some interesting comments. (Names have been omitted to protect the honest.)

Some examples:

“The Critical Path is tied in knots.”
“There is a ray of light – in Europe.”
“The EU will be setting the scientific standards of the future.”
“It’s time to get the focus back to science rather than suspicion.”
“We must escape from the risk swamp.”

Keep those cards and letters coming.

Keep up the pressure.

And keep the faith.  Read More & Comment...

Generics are easy. Innovation is hard.

10/17/2008 01:02 PM |

Pfizer has announced plans to sell cheaper versions of its competitors' branded drugs when they lose patent protection. Greenstone, Pfizer’s generics unit (which it inherited in the 2003 acquisition of Pharmacia) has primarily sold copycat versions of Pfizer's own branded drugs when they lost patent protection, not other companies' drugs. (Pfizer's generics business is among the Top 10 generic companies by sales as measured by IMS Health.)

And they aren't alone in making more aggressive moves into the generics business. Novartis’ Sandoz unit is already a leader here, GSK is partnering with South Africa's Aspen Pharmacare Holdings, and Daiichi Sankyo is taking a majority position in India’s Ranbaxy.

According to David Simmons, general manager of Pfizer's new Established Products unit "We're always about innovation, and it will always be the lifeblood and sustaining element of Pfizer, but we don't see it as the be-all and end-all.”

Business is business, and Pfizer’s decision makes sense.  But, when the world’s largest pharmaceutical company says that innovation isn’t the “be-all and end-all,” there’s a much larger policy issue at stake – like the future of innovation.

Innovation is slow.  As any medical scientist will tell you, there are few "Eureka!" moments in health research. Progress comes step-by-step, one incremental innovation at a time. Companies more often profit by improving existing chemicals and making processes more efficient than by revolutionizing the whole field with new products.

Innovation is hard.  Today it takes about 10,000 new molecules to produce 1 FDA-approved medicine. And if that's not frightening enough, only 3 out of 10 new medicines earn back their research and development costs. And here's the kicker -- unlike other R&D-intensive industries, pharmaceutical investments generally must be sustained for over two decades before the few that make it can generate any profit.

Innovation is expensive.  In 2003, researchers at TuftsCenter for the Study of Drug Development estimated the costs to bring a new medicine to market to be $802 million, and others suggest that the total cost is closer to $1.7 billion

Innovation is under attack.  From accusations of the “me-too” variety, to crackpot schemes to replace pharmaceutical patents with a “prize” system, life for innovator pharmaceutical companies is rough and tough.  Israel Makov (formerly the Big Abba of generics giant Teva) once told me that he wasn’t really in the pharmaceutical business, but rather “in the litigation business.”

(PS/ If we don't think seriously about serious patent reform and towards more robust protection of data exclusivity we are going to seriously jeopardize the potential for new medicines -- at a time when science makes potential breakthroughs tantalizingly close.)

But innovation is important – and not just for pharmaceutical industry profits. Increases in life expectancy resulting from better treatment of cardiovascular disease from 1970 to 1990 have been conservatively estimated as bringing benefits worth more than $500 billion a year. In 1974, cardiovascular disease was the cause of 39 percent of all deaths. Today it is about 25 percent. Cerebrovascular diseases were responsible for 11 percent of deaths back then. In 2004 they caused 6.3 percent of deaths. Kidney diseases were linked to 10.4 percent of deaths and now they are associated with 1.8 percent. And that’s just for the United States.

As Harvard University health economist (and Obama healthcare advisor) David Cutler has noted: "The average person aged 45 will live three years longer than he used to solely because medical care for cardiovascular disease has improved. Virtually every study of medical innovation suggests that changes in the nature of medical care over time are clearly worth the cost."

When innovator drug companies decide to play more aggressively in the generic drug world – that’s business, sound business.  When a senior executive at the world’s largest drug company says that innovation isn’t the “be-all and end-all” – that’s frightening, very frightening.

To borrow an over-used adjective from the world of global climate change -- we must protect "sustainable" innovation.

  Read More & Comment...

FDA Weaves a Web of Safety

10/16/2008 01:45 PM |

A worthwhile effort.  Hopefully this will be more than just a "must bookmark" for trial lawyers.

From the FDA website:

FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals
Comsolidates information in once access point

Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs. The Web page, http://www.fda.gov/cder/drugSafety.htm, provides links to information in these categories:

• Drug labeling, including patient labeling, professional labeling, and patient package inserts;
• Drugs that have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that their benefits outweigh their risks;
• A searchable database of postmarket studies that are required from, or agreed to by, drug companies to provide the FDA with additional information about a drug's safety, efficacy, or optimal use;
• Clinicaltrials.gov, a searchable database of clinical trials, including information about each trial's purpose, who may participate, locations, and useful phone numbers;
• Drug-specific safety information, including safety sheets with the latest information about the drug as well as related FDA press announcements, fact sheets, and drug safety podcasts;
• Quarterly reports that list certain drugs that are being evaluated for potential safety issues, based on a review of information in the FDA's Adverse Event Reporting System (AERS);
• Warning Letters, Import Alerts, Recalls, Market Withdrawals, and Safety Alerts;
• Regulations and guidance documents;
• Consumer information about using medications safely and disposing of unused medicines;
• Instructions how to report problems to the FDA through its MedWatch program;
• Consumer articles on drug safety; and
• The FDA's response to the Institute of Medicine's 2006 report on the future of drug safety.

"By placing Web links to these up-to-date resources on a single page, we're helping consumers and health care professionals find drug safety information faster and easier," said Paul Seligman, M.D., M.P.H., associate director of Safety Policy and Communication in the FDA's Center for Drug Evaluation and Research. "This type of communication is aimed at helping consumers and health care professionals make well-informed decisions about medication use."

Establishing such a Web page is one of the requirements of the Food and Drug Administration Amendments Act of 2007, and is among FDA's many efforts to address the safe use of drugs throughout their lifecycle.

  Read More & Comment...

Groucho Marx and FDA Advisory Committees

10/16/2008 01:22 PM |

Well, duh.  A new report from the GAO (Government Accounting Office) FDA Advisory Committees: Process for Recruiting Members and Evaluating Potential Conflicts of Interest, found that “FDA employed many of the same recruitment and evaluation practices used by organizations previously identified by GAO as employing methods that could ensure an independent and balanced advisory committee.”

“… an independent and balanced advisory committee.”  Thank you.

But, according to the report, the FDA faces barriers when it comes to recruiting qualified advisory committee candidates without actual or potential conflicts of interest.  According to the GAO, “the agency may have been able to mitigate these barriers by expanding its outreach efforts,” since “the same leading experts that industry sought to conduct research” are those being recruited to serve on FDA advisory committees.

Does “mitigate” mean recruiting the second best and the almost brightest?  Not acceptable.

It reminds me of the old Groucho Marx quip , "I wouldn't join any club that would have me as a member."

  Read More & Comment...

Who's Life Is It Anyways?

10/15/2008 04:23 PM |

Tykerb is one of the newest tyrosine kinase inhibitors (TKI).  It interrupts the signaling pathway that produces a specific protein involved in the creation and support of cancer cell growth.  It is a small molecule drug that can target both HER 2 and HER 1 breast cancers.  Because it is a small molecule drug and not a large molecule it can also enter the brain where up to half of all late stage breast cancers spread.  Also, recent studies presented at the American Society of Clinical Oncology Breast Cancer Symposium on September 5, 2008. have shown that Tykerb can be used in combination with new gene profiling tests to tailor treatment to patients who would gain the most benefit and least risk:
http://community.breastcancer.org/forum/73/topic/721033

"Conclusions of the study had shown that Tykerb has antivascular activity superior to that of Nexavar. Avastin + Tykerb may be the first clinically-exploitable antivascular drug combination. High dose, intermittent 'bolus' schedules of Tykerb to coincide with Avastin administration may be clinically advantageous, even in HER2-negative tumors.

The system utilized for the study was a functional profiling assay, which may be used to individualize antivascular therapy. It can be adapted for simple, inexpensive and sensitive/specific detection of tissue and circulating microvascular cells in a variety of neoplastic and non-neoplastic conditions, for drug development, and individualized cancer treatment.

The cell-based assay can accurately sort drugs into categories of above average probability of providing clinical benefit on one hand and below average probability of providing clinical benefit on the other hand, based both on tumor response and patient survival."


And so how doth the comparative effectiveness institute known as NICE rule upon the value of Tykerb:
 

The Wall Street Journal (10/15, B2, Berton) reports, "GlaxoSmithKline PLC's breast-cancer drug Tyverb (lapatinib) shouldn't be eligible for reimbursement under the U.K.'s publicly funded healthcare system," the U.K.'s National Institute of Clinical Excellence (NICE) recommended on Tuesday. The company said that NICE, "which decides what treatments are made available free to U.K. patients, isn't recommending Tyverb's use by the National Health System. In its decision, NICE rejected the drugmaker's offer to bear part of the cost of the treatment."

        The U.K.'s Telegraph (10/14, Smith) added that "trials of the drug...have shown it can reduce the size of a tumor by 60 percent and extend life by an average of two months, compared to standard treatment." But NICE "says it does not extend life by long enough to justify the extra cost."

As long as comparative effectiveness is conducted by the payor, for the payor and of the payor, the value of personalized medicine will be in the words of the Faber College's Dean Wormer:

"Zero, point zero." 

For a look at how NiCE conducts its comparative effectiveness work, take a look at this video: 

http://www.youtube.com/watch?v=xVdUsgYA_D4

 

  Read More & Comment...

Ode to a Canadian Physician

10/15/2008 01:15 PM |

At yesterday’s CMPI conference on the impact government-care has on physicians (in Europe, Canada, and the US), Brian Lee Crowley (President of the Nova Scotia-based Atlantic Institute for Market Studies) offered the following comments:

In summarizing the current state of the physician within the healthcare system in Canada I sought inspiration in poetry and was drawn to a poem by Elizabeth Barrett Browning, With apologies, I have somewhat modified her poem and entitled it:

Ode to a Canadian Physician

How do I disempower thee? Let me count the ways.
I disempower thee to the depth and breadth and height
My bureaucratic soul can reach, when some aspect of the health system escapes my
control.
For the ends of cutting my costs and using thy ideal Grace to shield me from the sting of
patient discontent.
I disempower thee to the level of everyman's
Most urgent healthcare need, by sun and candle-light, which are the pinnacle of the
technological sophistication thou art allowed.
I disempower thee freely, as men strive for “free” healthcare and end by merely
restricting access to thee.
I disempower thee purely, as they turn from specialists and hospitals in despair of finding
timely treatment there.
I disempower thee with a passion put to use
In my efforts to ingratiate myself with the electorate; Thank God for their childish faith.
I disempower thee with a loss of access to medical schools, thus ensuring that many will
never know the joys of thy tender care
I disempower thee with the breath,
Smiles, tears, and above all the income of all your life! --- and, if the Minister of Health
so choose,
I shall but disempower thee better if thou hast the temerity to prescribe a drug I judge too
costly, no matter how efficacious.

To reinforce his point in somewhat less poetic terms, Brian pointed to the following story that ran in the Canadian newspaper, the National Post, on August 06, 2008

MD uses lottery to cull patient list

In the latest jarring illustration of the country's doctor shortage, a family physician in Northern Ontario has used a lottery to determine which patients would be ejected from his overloaded practice.

Dr. Ken Runciman says he reluctantly eliminated about 100 patients in two separate draws to avoid having to provide assembly-line service or extend already onerous work hours, and admits the move has divided the community of Powassan.

Yet it was not the first time such methods have been employed to determine medical service. A new family practice in Newfoundland held a lottery last month to pick its caseload from among thousands of applicants. An Edmonton doctor selected names randomly earlier this year to pare 500 people from his heavy caseload. And in Ontario, regulators have heard reports of a number of other physicians also using draws to choose, or remove, patients, limit their prescribing to the state formulary, with sometimes extremely grave consequences for their patients.

Brian’s complete remarks can be found here.

Here is how he concluded his presentation:

Physicians surrendered great power to order their own professional lives and to act in the interests of their patients when physicians and hospital care was essentially taken under full political direction in the 1960s in a wave of ideological enthusiasm and economic ignorance. Despite the misgivings of some in the medical community, doctors largely embraced a public sector health care monopoly model, a monopoly that has only extended its tentacles and its centralising control in the intervening decades. Things are beginning to shift within the medical community, however, and the last two presidents of the Canadian Medical Association have been advocates of the private sector, a sea change of huge proportions. Like the wedding guest in Samuel Taylor Coleridge’s Rime of the Ancient Mariner, they have been traumatized by the brave new world of our health care system and are beginning to draw the policy conclusions that follow from that experience:

He went like one that hath been stunned,
And is of sense forlorn:
A sadder and a wiser man,
He rose the morrow morn.

Words for all of us to ponder on now -- rather than on the forthcoming post-election "morrow morn."

  Read More & Comment...

Equity vs. Equality

10/15/2008 02:26 AM |

Today the Center for Medicine in the Public Interest (CMPI) held a conference entitled, "Physician Disempowerment:  A Transatlantic Malaise."

The opening keynote was Francois Sarkozy, MD (yes, the brother of the other Sarkozy).  Among his provocative comments was the thought that, when it comes to health care "as a right" we need to distinguish "equality from equity."  Further, Dr. Sarkozy discussed the attempts by the French government to reform healthcare by via decreased centralization.  At a time when many here in the US are calling for precisely the reverse, it certainly calls into question the prevailing "SiCKO" mentality of healthcare reform.

Dr. Sarkozy also presented a videotaped interview with the French Minister of Health, Madame Roselyne Bachelot, who spoke on the need for more cooperation between the public and private sectors as well as progams to better empower physicians to deliver the care best care to their patients based on their best medical judgment.

Mais oui!

Swiss physician, Dr. Alphonse Crespo spoke of the "pencil" strike that brought the Swiss healthcare authorities to their knees.  Young physicians and many general practitioners, protesting the healthcare policies of the government, continued to see patients -- but refused to fill out the requisite paperwork.  Talk about cruel and inhuman punishment.

Jacob Arfwedson, CMPI's Paris bureau chief, in a discussin of healthcare technology assessment asked the question, "Is evidence-based medicine at odds with evidence-based policy?"  Hmm.

And much more from the likes of Brian Lee Crowley (Atlantic Institute for Market Studies), Scott Gottlieb (AEI), Michael Weber (CMPI), Harvey Bale (immediate past Director-General of IFPMA), Marc Siegel (CMPI), Gary Applebaum (CMPI), and others.

We will shortly post the complete video proceedings of this event.  Watch this space for further details.


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Giving Tax Credits Where Credits Aren't Due

10/13/2008 07:57 PM |

According to PxReporter...

"Developers of companion diagnostics products, integral to the advancement of personalized medicine, may receive a much-needed financial boost from Congress covering their research and development expenses if a new bill introduced by Rep. Patrick Kennedy (D-RI) passes.

 

The Genomics and Personalized Medicine Act of 2008, H.R.6498, would award “an eligible taxpayer [or test developer] the companion diagnostic test credit” in “an amount equal to the qualified research expenses paid or incurred by the taxpayer during the taxable year, in connection with the development of a qualified companion diagnostic test.”

Not so fast. The credit is offset against any expensing of R&D activities on corporate returns. And the carry forwards on the credits are non-existent as far as I can tell but I am no tax lawyer....

Meanwhile the bill, while well intended, creates new agencies, work groups and layers of review for a personalized diagnostic climb through before it gets approval, thereby adding to costs that can't be claimed under the credit itself.

Are tax credits the only thing pols can come up with to promote innovation?

Why not, for instance, build on the work of the C Path Institute?

"Last October....the C-Path Institute announced that it will use a $2.1 million Arizona state grant to help Ventana take a lung cancer diagnostic through the FDA and standardize a regulatory pathway for companion diagnostics and therapies [see PGx Reporter 10-17-2007].

 

Or support the Critical Path by funding Reagan Udall....

Johns Hopkins University’s Genetics and Public Policy Center’s Gail Javitt notes: “New committees and layers of bureaucracy are proposed when what is needed are concrete steps to enhance oversight and improve laboratory and test quality. …"

Let's hope clearer minds and the Critical Path prevail...

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How To Create Health Care Shortages

10/13/2008 03:43 PM |

For those eager to use the current response to the contraction in the credit markets to justify an expanded government role in running health care, there's a difference between injecting capital into the financial system and price controls folks. Capital formation is a result of creating incentives for risk taking and profits. Price controls and redistribution repackaged as "investment" does not have the same effect. The same goes for the claim that a stimulus package that includes more money for Medicaid will help grow the economy. If that was the case, an increase in the murder rate would be a stimulus policy because it would lead to higher spending on trauma care.

Meanwhile the hero of the Far Left -- Hugo Chavez -- provides a preview of how health care will fare under Obama and others in Congress seeking to cut Medicare spending through price controls and rebates:

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The Bermuda Triangle of Research and Resources

10/13/2008 11:00 AM |

If you want to see the future of pharma/academe collaboration, then the current edition of Intensive Care Medicine is a must read. The particular issue is the contentious debate over the role of the Eli Lilly & Co. drug, Xigris (drotrecogon alpha/activated – DAA), in severe sepsis.  But there are much larger issues at play.

Interesting Sidebar: The first Xigris Advisory Committee meeting was scheduled for September 12, 2001, but was cancelled for obvious reasons – and the Lilly team had to get back to Indy by bus.  It seems to have been worth the trip. (The rescheduled meeting was held on October 16, 2001 – and it was a lively one.)

Specifically, Lilly is conducting a placebo controlled study of Xigris in patients with septic shock, and the referenced study (PROWESS-shock) must have been a design nightmare given the past controversy -- in addition to the issues involved in conducting such a study while the drug remains commercially available. 

Here is the ICM article, “Design, conduct, analysis and reporting or a multi-national placebo-controlled trial of activated protein C for persistent septic shock.”)

But there are larger issues at play – such as a new model of academia-industry collaboration.  As Jordi Mancebo and Massimo Antonelli write in their ICM editorial:

“This month’s issue of the Journal contains a somewhat unusual article and two accompanying editorials.  The authors of the article are members of the steering committee of an on-going Eli Lilly trial on activated protein C for persistent septic shock.  They describe a number of steps that have been adopted in order to ensure transparency in disclosing financial conflicts, facilitate comprehension and interpretation of results, minimize possible risks, and maximize eventual benefits for patients.  This approach constitutes a new model of academia-industry collaboration.”

It’s also important to note that the academic steering committee will oversee not only the conduct of the trial (nothing new there) but will also write the study manuscripts.

Further on Mancebo and Antonelli write:

“The novelty here is the full disclosure of the process by which this study was designed, and a description of how it will be conducted, analyzed and reported.”

In a second ICM editorial, Peter M. Suter and Jukka Takala write about to who benefits from this “new model”:

“The primary objectives of each of the three stakeholders are quite different.  The pharmaceutical industry wants to make profit, but is also very much interested in bringing new products to the market (necessary for its sustainable development) and in innovation (which improves its image in the eyes of society).  Science is curiosity-driven, with the aim of furthering our understanding of human biology, physiology and mechanisms of disease, also to discover better ways to treat disease.  Finally, the objective of medicine is to help patients to get better quickly and to recover a good quality of life.”

Suter and Takala conclude:

“The investigators of the PROWESS-shock trial have made a laudable effort to introduce an improved model of collaboration between science, medicine and industry.  This approach could help to get us out of the image of a Bermuda triangle, where benefits of research and resources for health care disappear in a black hole or the wallets of a few.”

(This is the same Peter Suter who once said he wouldn’t give his own brother -- who had septic shock -- Xigris.)

As Mancebo and Antonelli write, “We welcome this unprecedented step forward.”

Amen.

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Parallel-o-gram

10/10/2008 11:15 AM |

According to the Financial Times:

“Drug distributors who arbitrage the price differences across the European Union could see their €4bn ($5.5bn) a year trade severely curtailed under proposed legislation set to be unveiled by the European Commission later this month. A document obtained by the FT includes rules to crack down on the trade in counterfeit medicines that would make it difficult for wholesalers legally to move pharmaceuticals across the EU's open borders. New rules would put tight restrictions on the repackaging of medicines, a process required to ensure the correct language and coding information is used on packaging and information leaflets.”

“The repackaging controls, drafted for Günther Verheugen, EU trade and industry commissioner, as part of broader reforms to laws governing the pharmaceutical sector, have been justified as a way to reduce the threat of counterfeit medicines, which the pharmaceutical industry says is a growing danger to patients' health.”

On the other side of the issue, Heinz Kobelt, secretary-general of the European Association of Euro-Pharmaceutical Companies, which represents parallel traders, said the Commission had been unable to provide any evidence that parallel traders had allowed counterfeit prescription medicines to enter the pharmacy chain.

Heinz has a very selective memory.

Earlier this year, at a London policy conference on parallel trade (where we both spoke), Heinz pointed out (correctly) that the recent spate of counterfeit drugs that had infiltrated legitimate UK pharmacies had been discovered by a parallel trader. And that’s true. But what he didn’t mention (and seems to have again conveniently forgotten) is that those same products had already passed through three other parallel traders without being found.

Oops.

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The Young & the Restless

10/08/2008 06:00 PM |

According to a new survey, “Millennial” voters (18-28 years old) -- often are portrayed as the new “driving force” in American politics -- place health care reform fifth on their list of electoral issue priorities (behind the economy, energy/gas prices, jobs/unemployment, and Iraq). But, when millennial voters are engaged on the issue of health care reform they have some very strong – and often contradictory – opinions about reform -- particularly when it comes to issue of “universal care.”

The Center for Medicine in the Public Interest (the public policy institute home of www.drugwonks.com) has just released a new survey of millennial views on health care reform. The national public opinion poll of young voters demonstrates limited acceptance for the potential consequences of greater government control over health care.

While millennial voters report to strongly support the need for reform and the concept of “universal care,” when asked if they are willing to pay higher taxes to pay for a government-run health care system, their level of support swiftly turns in the opposite direction.

Millennial voters are strongly against government-care that results in longer wait times to see a health care provider, limits to the types of treatments and medicines they can access, and the potential for the government to interfere in the decision making and relationship between doctor and patient.

Some germane findings:

* A majority (75 percent) of millennials were concerned about their current and future ability to access affordable health care

* Eighty-three percent of millennials believe that America’s health care system is in need of reform and that health care insurance should be available to all Americans; and,

 

* Seven in ten millennials support the creation of a new government program to manage and administer public health insurance coverage options, and 6 in 10 were okay with increasing government spending to support health care reforms.

However, as the potential cost of health care reform was shifted directly onto individuals and not the government the level of support for reform ideas also shifted among millennial voters.

* A majority (51 percent) were not in support of any health care reforms thatcould raise their personal tax burden;

 

* Sixty-two percent said they would not support any health care reforms that could increase wait-times to see a doctor or the availability of treatments and medicines; and,

* Millennial voters were also equally unsupportive (62 percent) of health care reforms that would increase the role of the government regulation and oversight in doctor-patient decision-making.

This healthcare “idealism gap” among millennial voters speaks to a large divide between what this group is hearing from politicians and pundits -- and what they are willing to accept. This insight into how younger voters think and feel about these healthcare reform shows that all sides of the debate need to do a better job educating this important voting bloc about how various reform plans will impact the future of medicine in America.”

For further details please go to www.biggovhealth.org.

This poll is the result of 1001completed interviews with adults 18-28 years of age who are registered to vote.  Respondents were selected at random from the 48 contiguous states.  The interviews were conducted between September 12th, 2008 and September 20th, 2008. The margin of error for this study is ± 3.09 percentage points at the 95% confidence level. Interviews were monitored at random. 

Sampling for this study was conducted using a national probability sample of all exchanges and area codes across the 48 contiguous States.  All interviews were conducted using a computer assisted telephone interviewing system.  Statistical weights were designed from the United States Census Bureau statistics.

 

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Taking a Stab at Inconsistencies in Suicidality Perspectives

10/08/2008 02:27 PM |

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