Comparative Effectiveness: Life vs. Death

04/10/2007 08:00 PM |

Rule Britainia? Time to change the rule.

From today's edition of the London Daily Mail, another example of so-called "evidence-based medicine" focusing on saving costs rather than saving lives.

Cut-price statins linked to increase in patient deaths
By RHODRI PHILLIPS

10th April 2007

Health chiefs are reviewing evidence which apparently shows a link between a cut-price statin and an increased risk of death among heart patients.

The drug, simvastatin, is taken by more than a million people to combat high cholesterol. Doctors were advised in January last year to prescribe it instead of more expensive atorvastatin.

But analysis carried out at University Hospital of North Staffordshire in Stoke-on-Trent shows that three times more patients on the cheaper drug died compared to those taking atorvastatin a year earlier. In the three months from December 2004 to February 2005, five out of 100 patients - or five per cent - prescribed atorvastatin died. But 20 of 121 patients - 17 per cent - on simvastatin died between December 2005 and February 2006.

Now the National Institute for Health and Clinical Excellence (NICE) is reviewing the use of simvastatin.

Dr Giri Rajaratnam, Stoke-on-Trent's public health director said: "NICE are doing a full-scale review of statins, looking at the balance between safety and effectiveness and severity of illness."

Two million people in Britain take statins to lower their cholesterol and help protect against the risk of stroke or heart attack. Since simvastatin was introduced three years ago as a cheaper option, 60 per cent have made the switch.

NICE, which advises NHS trusts on the use of drugs, said a 28-day course of simvastatin given to patients in 40mg doses, costing £3.57, was the equivalent to a 28-day course of 10mg atorvastatin tablets, costing £18.03.

Last year the British Medical Journal predicted the NHS could save £2billion within five years if doctors prescribe the cheaper drug. Simvastatin can be bought over the counter, while atorvastatin is only available on prescription.

Cardiologist Dr Rob Butler, who carried out the research, said: "A decision was taken between the local primary care trusts and the local National Health Service trust to switch to generic simvastatin.

"We decided to audit the effects. We were principally looking for differences in numbers of patients needing to be readmitted following discharge. But we were surprised when we saw such a difference in the death rate."

Dr Butler, who has previously received payment from a number of drugs companies, including Pfizer - which makes atorvastatin under the brand name Lipitor - also noticed more patients returning to hospital for further treatment after using simvastatin.

Dr Rajaratnam has also ordered a review into the statin drugs following Dr Butler's research. However, simvastatin is still being used.

A joint statement issued by the hospital and Stoke-on-Trent Primary Care Trust last week said their policy on statin use was consistent with NICE guidance.

It added: "To determine whether our policy should be amended in light of further evidence, the health economics unit at Birmingham University will consider whether any sub-groups of patients would benefit from intensification of their statin treatment.

"The North Staffordshire guideline will be reviewed in the light of its results."

The NICE advice published in January 2006 advised doctors to prescribe simvastatin as a first resort but to use their judgment if they thought another drug such as atorvastatin was more appropriate.  Read More & Comment...

The New Republic Sounds Old and Tired on Health Care

04/10/2007 03:18 PM |

http://www.tnr.com/doc.mhtml?i=w070409&s=cohn041007

According to Jonathan Cohn of The New Republic universal health care ala Europe (note he excludes Canada!) is a great model for America because....

"You don't see their citizens choosing between prescriptions and groceries, or declaring bankruptcy, because of medical bills. "

Well Jon, that's because the European bankruptcy system is based on a debt counseling model while in the US (and Canada) we have an easier path to permit public assumption of private debt. Given Canada's social safety net, in 1997, the incidence of personal bankruptcy was 3 in 1000 there cf to 5 in 1000 in the US.

Oh.

Moreover, according to the Federal Reserve, debt as a percentage of household income is higher in the UK, Japan and Canada than it is in the US (which has the same ratio as Germany and higher than France).

Oh.

There are surveys galore that also claim up to 35 percent of seniors choose between food and home heating bills.

Should we have universal food insurance or universal heating coverage too, with consumption and price levels set by government?

If Cohn and other liberals want to diddle around about whether you can get better care in the US or Europe or Canada or Japan that's fine. The reality is that everyone else waits longer than Americans for all kinds of care, particularly cancer care and low birth weight babies are less likely to receive life sustaining care anywhere else on the planet. We do have gaps and holes in our system of coverage but they are created because of duplication and regulations that protect corporations, insurance companies and unions from market competition.

America has a health system better prepared to deal with an aging society, better positioned to invest in the health of its citizens for long term prosperity and independence, more dedicated to extending and enriching life at both it's beginning and end and poised to achieve in greater gains against infectious diseases and chronic illnesses than any other nation in the history of mankind.

Europe's health care system is tethered to an unsustainable method of financing --a shrinking work force paying higher taxes -- and is propped up in the short term as it's military by an indirect subsidy from America's technological superiority and inventiveness. That too is coming to a quick end as health systems throughout the continent are explicitly and implicitly rationing access to the best and newer medicines.

Cohn and other liberals want us to believe universal health care leads to better health. But the gap in health status between rich and poor, educated and uneducated here and abroad are largely the same.. Health care might be free but if you lead a chaotic and disorganized life or engage in risky behavior or postpone seeking care your chances of survival decline. And time is not free to anyone regardless of income. Ultimately, time has a cost and it exacts a particularly heavy one on the poor and elderly. Countries that ration access to the right treatment at the optimal time through waiting, canceling appointments, gatekeepers etc, step therapy kill their society from within.


As quick PS added April 11... The tool the Euros use to ration? Comparative effectiveness analysis. Which is what the Dems are pushing for in order to push down drug prices and access to new drugs.  Read More & Comment...

"Des-Pearate" Measures: NYT Mischaracterizes FDA's Woodcock on FOBs

04/09/2007 03:31 PM |

In an effort to find a counterpoint to industry concerns about follow on biologic legislation (here's goes my chance to land on his speed dial) Robert Pear mis-characterizes Janet Woodcock's clear and unambiguous testimony stating that the FDA had the regulatory authority and know how to develop a pathway for the approval of FOBs. He makes it seem that Woodcock claims you don't need human testing to establish that two biologics are interchangeable.

Brand-name drug manufacturers have urged Congress to require human trials before allowing the sale of any products billed as comparable or equivalent to biotechnology medicines already on the market.
''Some level of clinical testing should be required in all cases,'' said Dr. Susan D. Desmond-Hellmann, president for product development at Genentech.
Dr. Jay P. Siegel, a senior scientist at Johnson & Johnson, said: ''I would never take a biologic that had not been tested in humans. The risks are too high.''
But Dr. Woodcock said: ''Where trials are not needed, it is of questionable ethics to repeat them. The use of human subjects for trials that are not needed is not desirable.''

Woodcock said nothing of the sort. Here is what she said:

"To establish that two protein products would be substitutable, the sponsor of a follow-on product would need to demonstrate through additional clinical data that repeated switches from the follow-on product to the referenced product (and vice versa) would have no negative effect on the safety and/or effectiveness of the products as a result of immunogenicity. For many follow-on protein products -- and in particular, the more complex proteins – there is a significant potential for repeated switches between products to have a negative impact on the safety and/or effectiveness. Therefore, the ability to make determinations of substitutability for follow-on protein products may be limited."

Here is a link to Dr. Woodcock's testimony.

http://www.fda.gov/ola/2007/protein32607.html

Pear thinks it gave legislation for FOBs an "unexpected boost."

Really? The holy grail for the generic industry and Bashir Assad's new accountabilabuddy Henry Waxman is substitution. That sound you hear is the air being let out of the FOB money saving balloon just like when Waxman and Ron Pollack (proud recipient of money from George "de-Nazify America/majority Halliburton shareholder" Soros pushed Medicare price control legislation claiming $200 billion in savings.  Read More & Comment...

FDA Reform: A Pet Project?

04/06/2007 08:20 AM |

Much chatter about contaminated pet food.

Not surprisingly, media focus is on grieving pet owners rather than on the real issue -- why did it happen and how can it be prevented from happening again.

The answer, more money for the FDA. If you think that FDA is under-funded when it comes to drugs and devices -- check out the abysmally low budgets for CFSAN and CVM.

Penny wise and pound (no pun intended) foolish? Neither. Dangerous.  Read More & Comment...

the plight of smokers

04/05/2007 06:50 PM |

I'm looking forward to the results of the NIH trial, but I don't think there is truly much controversy about the usefulness of this test, esp. in the right hands.

Perhaps politically, smokers aren't the most popular group, and a nicotine-blocking drug like Chantix has been a wonderful addition to my clinical arsenal. Better to be a non-smoker, whereupon the risks drop dramatically. I've written previously - 1-06 - for the Wash Post about how quitting can best be accomplished by a change in lifestyle, and how quitting decreases both short term and long term health risks.

http://www.washingtonpost.com/wp-dyn/content/article/2006/01/02/AR2006010201507.html?nav=rss_health

But for those who haven't quit, and even for those who have, screening at some regular interval has important health benefits.

Here's an interesting study just published - the mention is in Cancer Research UK:

Lung cancer screening effective for high-risk groups, says US group

FRIDAY 30 MARCH 2007

Screening high-risk individuals for lung cancer with an annual 'CT' scan may be able to detect tumours when they are most treatable, according to new US research.

The New York Early Lung Cancer Action Project study, published in the April edition of Radiology, examined the screening results of 6,295 former smokers aged over 60.

A total 124 of these people were diagnosed with lung cancer.

Almost nine in every ten of those diagnosed were found to have tumours that that had not yet spread.

Lung cancer screening is an area of intense interest, as currently most lung cancers are not detected until they are at an advanced stage when the disease is extremely difficult to treat successfully.

The new findings run counter to research published in March in the Journal of the American Medical Association, which suggested that CT screening may not significantly reduce death rates, despite detecting more cancers.

Some scientists think that CT screening may also be detecting slow-growing tumours that would not cause harm, leading people to be treated unnecessarily.

"The JAMA article was the first application of a newly developed computer model which predicted expected deaths from lung cancer, and there are numerous concerns about its validity," said Dr Henschke.

The US National Cancer Institute is funding a large trial, NLST, involving over 50,000 people, with results expected in 2009. This trial should answer questions over the effectiveness of CT screening and chest x-rays in reducing lung cancer deaths.  Read More & Comment...

French Twist

04/05/2007 10:22 AM |

I've just returned from a breakfast (kindly organized by the Government of France) with seven leading French journalists. The topic: health care. Needless to say, it was a wide-ranging conversation. A few items of note:

(1) My French is really rusty.

(2) While the systems in France and the US are very different, we share many of the same problems -- the biggest being government focus on cost rather than care.

(3) We spent a lot of time talking about how to measure the beneft of incremental innovation -- as well as what incremental innovation means and why any conversation on this topic must also include (and to a very large extent) how to expand the use of existing medicines in additional ways. We talked off-label usage.

(4) We talked comparative effectiveness and whether or not current measurements of such are legitimate ways to determine reimbursement decisions. (In other words, we spent a lot of time talking about the inappropriate ways payors -- public and private, HAS and DERP -- use general population RCTs to make "me too"/either-or decisions.

(5) And we talked about patient information. Empowering the consumer? Mon Dieu!

(6) And the fact that patient groups that are government funded are unlikely to be real patient advocates when it comes to therapeutic reimbursement decisions.

(7) And we talked about the importance of prevention programs. (Although I must add that, after the breakfast was over, they all went outside for a smoke.)

But the general theme that drove the entire conversation was, as mentioned above, what happens when cost trumps care and short-term political concerns dwarf long-term consequences.

And, no matter what language you're speaking, it sure sounds familiar.  Read More & Comment...

Barack's Obysmal Health Care Meeting

04/04/2007 02:36 PM |

"We all do no end of feeling and we mistake it for thinking. And out of it we get an aggregation which we consider a boon. Its name is public opinion. It is held in reverence. It settles everything. Some think it is the voice of God."

Mark Twain

I was going to download a webcast of Barack Obama's community meeting on healthcare in Seacoast, NH but found a newspaper account first. I am glad I did not waste the bandwidth.

If it was a battle between being banal (Barack) or bereft of insight (the attendees from Seacoast) they would still be slugging it out for first prize.

How do the Seacoasters and Obama fare? Let's restage it as drama:

Barack:"When I take office, I have to feel I have a mandate for change."

Laurie MaCray: "I don't want anymore competition - it's too confusing, it's trying to compare apples and oranges,I want a system with no deductibles, no co-pays. I want a national standard that insurers have to adhere to or not sell insurance."


Richard Friedman, MD "The problem is overuse of testing and high-priced drugs."

"We don't care how the system is managed as long as it is affordable and accessible to everyone."

Obama: ""Ultimately, (my plan) will be my best take on a comprehensive health care policy.

"I'm not going to be able to do this by myself."

My advice. Don't count on Seacoast for direction.

PS. Isn't that what people are electing YOU for?  Read More & Comment...

drug resistance - flu drugs

04/04/2007 12:09 PM |

Here's an interesting story by the Healthday reporter which was published in the Wash Post, Forbes, and several other places.

I was quoted extensively about neuraminidase inhibitors in the context of cautioning overuse based on FEAR, but of course avocating appropriate use.

Resistance patterns are emerging in Japan in Influenza B strains according to a new study out of the University of Tokyo.

http://www.washingtonpost.com/wp-dyn/content/article/2007/04/03/AR2007040301282.html  Read More & Comment...

Selective Transparency

04/04/2007 10:21 AM |

An editorial in today’s edition of the Minneapolis Star Tribune calls for consumers to “weed out conflicts in prescription drugs.”

According to the Star Tribune ...

“If you've taken a prescription drug lately, you might be feeling a little queasy about two recent Star Tribune stories showing that hundreds of Minnesota physicians accepted millions of dollars in fees, trips and other payments from the nation's drug manufacturers. Even assuming that doctors adhere to the highest professional standards, even assuming that the drug companies have the purest motives, this has to leave the average patient wondering if he or she got the safest, cheapest, most appropriate medicine on the market -- or the one that a drug company is pushing hardest at the moment.”

Talk about a loaded question!

But wait, it gets worse. The editorial continues …

“Consumers who are asking that question have a new ally called the Prescription Project. It's a coalition supported by Consumer Reports magazine and funded by the Pew Charitable Trusts to reduce conflicts of interest and make sure doctors are using the best unbiased research. The Minnesota Medical Association recently endorsed the website it uses to help inform consumers.”

But the editorial fails to mention that Consumer Reports also receives significant funding from the Engleberg Foundation – whose dollars come from no less a personage than Alfred Engleberg – who has earned northward of $100 million by successfully challenging the validity and enforceability of pharmaceutical patents and has generously shared in the resulting profits shared by generic drug makers. And, curiously enough, that funding is used to operate CR’s pharmaceutical “Savings Advisor” that offers, among other suggestions, “best buys” for Alzheimer’s medications.

An oversight on the part of the Star Tribune editorial page? Or just the most recent example of selective transparency?

Here’s a link to the full editorial:

http://www.startribune.com/561/story/1098522.html

If the Star Tribune believes that health care consumers deserve transparency, they should Gopher broke and do it right.  Read More & Comment...

Aging Matilda

04/03/2007 09:27 AM |

A new Austrailian report estimates that government spending on the private health insurance rebate, which costs about $3 billion Aussie dollars a year, will grow at 4.4 per cent a year -- nearly three times the expected real growth of the economy over the next 40 years.

Sound familiar?

The opposition's health spokeswoman, Nicola Roxon, said the report showed the Government was "once again shutting its eyes to the implications of chronic disease."

"The glaring gap in the previous intergenerational report was an assessment of the impact of chronic disease and preventable disease on current health expenditure, future health expenditure, workforce participation and productivity and, staggeringly, that mistake is repeated in the report released today," Ms Roxon said.

Saying it is the first step towards addressing it. Where are the American elected officials talking about the need to focus on dealing with chronic diseases (such as diabetes, hypertension, high cholesterol, etc.)?

The single biggest recent step towards getting tens of millions of Americans properly treated for chronic disease is Part D. More seniors are being properly diagnosed and treated for chronic diseases today than ever before -- a direct result of Part D.

(A fact that, mysteriously, didn't make the recent 60 Minutes story on the MMA vote.)

Beyond Part D, however, all players in the health care game (government, pharma, providers, private payors, and John Q.Patient) need to team up to address chonic disease in ALL populations ... before we find ourselves, well, down under.  Read More & Comment...

zelnorm

04/02/2007 12:34 PM |

I don't want to say too much about this until the smoke clears, but some early observations:

1 - the drug was quite effective in some patients with severe irritable bowel symptoms esp. constipation, but many others with milder symptoms respond to miralax and fiber.

2 - 29 placebo controlled 1-3 month trials of over 11,600 patients receiving Zelnorm and over 7000 receiving placebo show a slight increase in the risk of cardiovascular events including angina, heart attacks, and strokes in those taking zelnorm - .01% on placebo, .1% on the drug, but these studies for the most part involve patients in higher risk groups than those i and others would prescribe it for and for some also a longer use of the drug.

3 - but the FDA acted quickly in its public advisory and Novartis has agreed to stop marketing the drug and selling it in the U.S. So why isn't the FDA being praised for its action on behalf of drug safety?

it makes sense to keep this drug in reserve for those in lower risk groups who really need it. It makes sense to not inflame this news and start criticizing everyone in sight. The FDA is being cautious - Novartis is being co-operative.  Read More & Comment...

Sometimes Safety

04/02/2007 11:03 AM |

Can drug safety be a sometimes thing?

I pose this question based on the recent flurry of media stories on the need for new cancer treatments (see yesterday's NY Times Week in Review section) and the Abigail Alliance lawsuit that calls for greater patient access to investigational new drugs-- not to mention the debate over follow-on proteins.

(Remember, don't call them generic biologics. Words count.)

These are all important stories with significant subtexts -- most of which are entirely ignored by pols and pundits who prefer righteous indignation. Should we strive for new cancer treatment? Of course. Should patients have easier and broader access to investigational new drugs? I think yes, but there serious safety concerns that cannot just be ignored in the quest for a good headline. Follow-on proteins, same thing.

Don't get me wrong, I'm all for righteous indignation but, when it comes to drug safety, can you be for it before you are against it and still expect to be taken seriously?

Lots of well-intended verbiage in, for example Sunday's Times op-eds about the "need' without focusing on the "how," the "who," or the "how much." Many of these articles make it seem as though Big Bad Pharma is holding back on pursuing R&D for new cancer treatments because of concerns over profitability. Others blather on about Big Pharma sitting on potentially potent patents for the same reason -- with quotes from academic researchers who believe the translational gap is nothing more than the manifestation of a lazy pharmaceutical industry.

Sorry fellas -- ain't that easy.

I went through all of the articles (yesterday and today) and also did a Google search of how many times the FDA's Critical Path initiative was discussed.

Yup -- zero.

The Critical Path must not be paved with good intentions alone -- but some acknowledgement would be right and appropriate.  Read More & Comment...

Doubting Tomas

04/02/2007 10:34 AM |

Regular readers of DrugWonks.com know that when pundits and pols call for FDA reform, we urge them to "Show me the money" that such efforts deserve. Mostly, we're still waiting.

Now my former FDA colleague (and current CMPI Board of Advisors member) Tomas Philipson (along with two of his colleagues from the University of Chicago) asks, in a terrific guest editorial in current edition of Health Economics, "Where is the science?"

He refers, of course, to the recent IOM study which places politics before science and rhetoric before reality.

Here's a link to the editorial:

Download file

Thoughts and comments appreciated.  Read More & Comment...

A new class of drugs

04/02/2007 09:31 AM |

In my column, Antidote, for M, M & M this month, I discuss Tekturna, the first in a very promising new class of hypertensive drugs. It is no accident that this drug has come in "under the radar" at a time when so much of the main stream media appetite involves bashing drugs and drug companies, rather than championing great discoveries. Of course this climate, while making companies paranoid to dot every "I" and cross every "T" can also negatively effect drug research both short and long term.

Happy Passover to all.

Here's the column:

ANTIDOTE: 4-07 by Marc Siegel MD

Novartis has a new drug that has just been approved by the FDA. It’s called Tekturna. It’s the first new class of hypertensive drugs in ten years, something well worth celebrating. But it’s “coming out party” has received little medical attention.

Why?

It’s not for lack of importance. Tekturna is a first of its kind once a day renin blocker. Hypertension afflicts close to one billion people worldwide, and is uncontrolled in 70%, leading to heart disease, kidney failure, and stroke.

Renin is a crucial hormonal trigger of the renin-angiotensin system which ultimately leads to the production of the important adrenal hormone aldosterone, while at the same time constricting the body’s arteries.

In a clinical trial involving 6,400 patients, Tekturna significantly lowered blood pressure for 24 hours and was also effective in combination with other medications. Considering that the renin-angiotensin system is an essential cause of high blood pressure and heart disease, and that the blockers already on the market that interfere with angiotensin-converting enzyme or block the receptor for angiotensin II have been highly successful and life saving, the need for an effective renin blocker is undisputed.

So now along comes the first drug of its kind, potentially the most powerful drug in the angiotensin axis, and no one pays attention. Is the blood thirsty zeal of drug company attackers so potent that it overwhelms and obscurs all positive reports about a new class of drugs? I’m afraid so. Is it more important to attack Merck over the rare side affect of Vioxx than to champion Novartis for breaking through with a new discovery? I definitely don’t think so.

If we want our drug companies to thrive and spend the billions necessary to break through with a new category of drugs, the least we can do is congratulate them when one succeeds. Those who make an unremitting habit of bashing drug companies about unforeseen side effects could cost them so much money and public embarrassment that it takes the legs out of important projects like the one that led to the birth of Tekturna. In the current climate, it is probably no coincidence that it took ten years to come up with a new category of blood pressure drugs.  Read More & Comment...

Provenge: One Small Step for Cancer Patients

03/30/2007 12:44 PM |

The decision by the advisory committee to both approve Provenge using subpopulation data that ODAC did not readily provide and do so by rewriting the question provided by the FDA (asking if the drug for prostate cancer was effective as opposed to asking was the drug was substantially effective for an entire population.)

And it did so despite the fact that develop Dendreon has hardly begun to enroll patients in the post market trials the FDA and its safety mongering overlords in Congress such Ed Markey, Henry Waxman and Chuck Grassley are demanding.

For this round score it: Cancer patients 1 Postuing fearmongering pols and CYA bureaucrats 0  Read More & Comment...

Healthcare Realpolitik

03/30/2007 12:27 PM |

Some key take-aways from yesterday’s joint Center for Medicine in the Public Interest/Old Dominion University conference on Comparative Effectiveness:

• My opening question to the panel was whether or not comparative effectiveness (aka evidence-based medicine, aka healthcare technology assessment, aka rational use of medicine) was focusing on cost rather than care. Practice variation vs. patient variation.

•Carolyn Clancy (Director of AHRQ) remarked that we need to capture clinical data from off-label prescribing.

• Scott Gottlieb pointed out that the value of studying Avastin vs. Erbitux or Actos vs. Januvia is of no value – but that studying Avastin+ Erbitux and Actos + Januvia would yield important clinical information.

In short – if you don’t ask the right questions, you won’t necessarily get the wrong answers – but you won’t get the answers that will help improve patient care on the clinical level.

There was much conversation about the relative benefits of RCTs vs real life epidemiological data (like off-label prescribing outcomes). Look at it this way – consider each separate pieces of software designed for different purposes. Both are relevant to any discussion of comparative effectiveness – but only one “software” is used – RCTs (by DERP, Consumers Union, etc.). We need to design a software interface that will allow these two data sets to “talk” with each other.

The time for puritanical allegiance to RCTs is coming to an end.

Panelists were also brutally honest when it came to the question of cost-over-care, the new health care realpolitk, agreeing that when it comes to Washington, DC – cost containment will win out over patient care every time.

Unfortunately I agree – that’s the way it is right now. But that has to change. As John Bridges (Johns Hopkins Bloomberg School of Public Health) commented, “There is no health care without the patient.”

When it comes to changing the short term, politically-driven cost-over-care debate to a long term, patient-focused right-care-for-the-right-patient at-the-right-time paradigm, yesterday’s debate wasn’t the end, or even the beginning of the end but, hopefully, the end of the beginning.


And, when that day comes, it will indeed be health care's finest hour.  Read More & Comment...

CBO: Part D gets an A

03/30/2007 09:45 AM |

Attention Drugwonks:

The Congressional Budget Office has lowered the 10 year cost projection of the Medicare drug benefit by $387.2 billion or 32.3 percent as compared to last year's 10 year projection.

The learning is that competition and private negotiations are saving taxpayers and beneficiaries far more money than our worthy, non-partisan government actuaries had anticipated.

And in congressional testimony before the House Budget Committee, CBO Director Orzag recentlsaid that actual prescription drug plan bids for 2007 were 15 percent lower than the bids in 2006.

Imagine that -- a government program that, per capita, actually decreases in cost from year-to-year.

Competition works.  Read More & Comment...

Congress vs Patients

03/30/2007 08:34 AM |

The Washington Times
www.washingtontimes.com
Restricted treatment
By Robert Goldberg
Published March 29, 2007
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This week there were two bits of news that reminded most of us that when it comes to medicine, the real crisis is not safety but the lack of treatments to prevent or at least battle disease effectively.
First, the Alzheimer's Association released revised estimates showing that the number of Americans with Alzheimer's jumped from 4 million to 5 million over the past decade, a trend which, if left unabated by new medicines, will triple to 16 million by 2030.
Second, Elizabeth Edwards and Tony Snow announced that their respective breast and colon cancers had come back and spread. The likelihood of each's survival depends on a complex combination of factors that are increasingly understood, which has translated into better drugs and longer lives. As Allan Lichter, president of the American Society of Clinical Oncologists, said recently, "in the years ahead, doctors will be able to detect cancer early with a blood test, a blood signature, if you will." The same knowledge used to detect cancers at their earliest stage will be used to develop drugs to treat them at that nascent and intimate level, making them increasingly curable. The same goes for Alzheimer's. If caught early, it can possibly be delayed for years.
Don't count on these breakthroughs anytime soon. It is taking longer than ever to bring new medicines to market. The Enhancing Drug Safety and Innovation Act currently under consideration in Congress will ensure that millions of Americans will die waiting for medicines that politicians purport to protect them from.
The act requires that before any drug is approved, a risk-management program (RiskMap) be created. As former FDA Deputy Commissioner Scott Gottlieb points out, this "legislative proposal extends the FDA's ability to restrict which physicians can prescribe a medicine, and which pharmacies can dispense it." Mr. Gottlieb notes that the FDA now limits RiskMaps to about two dozen drugs with very serious or poorly understood side effects. Getting these drugs is burdensome for patients who want them. Severe penalties await doctors and physicians who prescribe and dispense them outside of FDA guidelines.
But Congress wants to extend RiskMAPs in order to prevent possible rare side effects by limiting who can prescribe new drugs, for what uses and to whom. Under the current legislation, doctors and pharmacists who violate a RiskMap are subject to civil penalties. No doubt being accused will lead to criminal proceedings and personal injury cases. All of this means that the current legislation takes the off-label prescribing of new drugs -- though such prescribing is standard for breast cancer, Alzheimer's and mental illness -- and virtually makes it a criminal activity.
I once supported the act, known as Kennedy-Enzi. That was before its authors decided that the best way to protect the public from adverse drug events is to replicate clinical trial conditions in the real world. RiskMap could create the equivalent of a prescription-drug police state, complete with computerized monitoring by the FDA of who gets what. My friend's father was locked out -- literally -- by a computer from receiving a cancer drug on a clinical trial because his pulse was less than a tenth of second off the interval set by the FDA. No access. No treatment. If the doctor had tried giving him the drug, it would have triggered an investigation and closed down the entire trial.
This approach could be applied to millions of Americans as doctors, hospitals and pharmacists, terrified by the threat of FDA oversight, congressional hearings and lawsuits, are bludgeoned into practicing cookbook medicine. Which health plan would dare to pay for a drug that doesn't meet RiskMap mettle? The legislative push is already slowing drug approvals because FDA drug reviewers are afraid of second-guessing by the media and Congress. A new drug for diabetes-related blindness to be approved this year may now be delayed for three more years of study. A drug to treat gram-negative sepsis that was supposed to be tested against the current medicine must now be tested with a group of patients that get a placebo (a sugar pill) to satisfy the demands of Rep. Henry Waxman. Yet, in many cases, gram-negative sepsis is 100 percent fatal.
The FDA is already delaying accelerated approvals of cancer drugs until dying patients are enrolled in double-blind, randomized, placebo-controlled, post-market studies. Kennedy-Enzi wants to make this practice mandatory. That means no accelerated approval at all for cancer or Alzheimer's.
These restrictions will choke off hope, scare off innovation, give trial attorneys control over the health-care system and deny many of us longer life. The congressional assault on medical innovation is not a presidential campaign issue yet. Perhaps, thanks to the courage of Mr. Snow and Mrs. Edwards, it will be.

Robert Goldberg is vice president of the Center for Medicine in the Public Interest..  Read More & Comment...

Comparing Notes on Comparative Effectiveness

03/29/2007 07:54 PM |

CMPI co-sponsored a National Forum on the role comparative effectiveness research should play in health care decisionmaking with Old Dominion University medical school today....

The take away message was put best by Johns Hopkins University professor John Bridges...there is no health care without patients. Any effort to impose a cost-driven comparative effectiveness research agenda on patients will fail. It was also put best by Scott Gottlieb who said comparative effectiveness is not about false choices between two drugs, choices driven by a political agenda.

In the end, the only research that matters of the comparative kind will help determine which treatment works best for which individual and help individuals shape the nature of treatment.

Politicians who proceed otherwise will proceed at their peril.  Read More & Comment...

My Main Man Merrill

03/29/2007 02:23 PM |

Merrill Matthews and I don't see eye-to-eye on everything when it comes to Medicare reform, but there's one thing we do agreed on ... it's working.

Have a look:

http://www.mercurynews.com/search/ci_5537368/nclick_check=1

As always, looking forward to all your thoughts and comments.  Read More & Comment...