New Blood Test for Detecting Alzheimer's: Capitalist Tool?

10/15/2007 10:13 AM |

Article today on efforts to develop a biomarker based test to predict early onset of Alzheimer's underscores the valuable role the Reagan Udall Foundation can play and the extent to which its "critics" are engaged in ad hominem attacks that flow from rage instead of science.

Blood Test Might Spot Alzheimer's Early

By Jeffrey Perkel
HealthDay Reporter 2 hours, 10 minutes ago

MONDAY, Oct. 15 (HealthDay News) -- An international team of scientists has developed a blood test that could reveal which patients with mild cognitive impairment will go on to develop Alzheimer's disease.
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If replicated and validated -- and assuming the development of effective treatments against Alzheimer's in the future -- such a test could open the door to medicating at-risk patients earlier and slowing or limiting neurological damage, explained Dr. Allan Levey, chair of neurology at Emory University, Atlanta.

"If it can be replicated, then we will find out how important [the study] really is," said Levey, who was not involved in the research.

Reagan Udall would help not only in replication and validation but set up standards for its approval by the FDA. Sharing data from the test would lead to more specific and early treatment of people and new medicines. As a recent CMPI study found, if we delay onset of Alzheimer's by 5 years it would be worth nearly $2 trillion to the United States.

How sad that so many interest groups and professional cranks (like David Ross) have lined up so quickly to attack an institute with such a profound and humane mission and have condemned its biomarker based work as dangerous.

http://news.yahoo.com/s/hsn/20071015/hl_hsn/bloodtestmightspotalzheimersearly  Read More & Comment...

Cancer Rates Decline Again: CMS Sure To Stop That

10/15/2007 09:48 AM |

The great news; Cancer rates are declining once again and falling faster than ever before thanks to advances in screening and treatment of lung, breast and colorectal cancer.

The bad news: The CMS decision -- made in an effort to position itself as Hillary Clinton's Best Practice Institute -- will deny cancer patients access to blood boosting drugs that make such treatments -- and the increased survival -- possible.

Here's what prospective randomized trial of colorectal cancer patients found:

"Anaemia was a strong predictor for activity of first-line 5FU-based chemotherapy especially in those groups that showed the best responses, for example high performance status, infusionally treated, higher 5FU dose and those with liver secondaries. Patients with higher haemoglobin levels recorded a greater response rate and a longer time to progression and survival than anaemic subjects. Prospective evaluation of role of correcting anaemia on response to therapy is justified by these results."

Br J Cancer. 2006 Jul 3;95(1):13-20. Epub 2006

CMS -- with it's decision to withhold access to ESAs that correct anemia in cancer patients - is sure to join the ranks of the UK is insuring that more people die of cancer than medical science would permit.  Read More & Comment...

Reagan-Udall Ready to Rock?

10/15/2007 09:06 AM |

The Reagan-Udall Foundation was created to promote new tools to accelerate the development a new generation of targeted medicines. The emphasis is on tools, meaning biomarkers, meaning coming up with validated measures and standards at a time when we have a lot of data and information but very little knowledge.

I hope the Foundation focuses on very mundane and important scientific work and provides hub for achieving consensus on measures and markers for qualifying and ap approving drugs based on actual biological differences and mechanisms. And I hope pharma does begin to more money into credible scientific projects that will help change the regulatory paradigm. The scientists in the companies want to do the right thing. I am not always so sure of the marketing types who still cling to the one size fits all blockbuster mentality and who have not yet realized that if drug companies don't get into the business of tracking the safety of their drugs in the post market -- using these tools in research and clinical settings -- they will continue to get clubbed by the likes of Nissen and Graham. If they don't seize the opportunity given to them in Reagan Udall then well....it's their own fault.

Of course, the fact that this might make drug development more efficient years from now (i.e. fewer clinical trials, more subpopulations targeted) and might help drug companies will drive the Marcia Angells, Kassirers, Avorns, etc crazy. Matt Perrone has an excellent piece that captures the knee-jerk "corporations are evil" bleating from the likes of The Union of Conceited Scientists.

Matt Perrone ought to brush up on what a biomarker is however otherwise he will continue to be misled by likes of David Ross who gave him this example:


"For example, Ross, who left the FDA last year over a drug safety dispute, is concerned, as are others, that the FDA might be persuaded to quickly adopt a controversial drug-testing process that uses biological indicators, such as blood pressure and cholesterol levels, to determine a drug's safety.

Drug companies have taken the unusual step of sharing research data on these indicators, called biomarkers, to see if the size and duration of patient drug trails can be reduced. Some critics call their use a high-risk gamble.

"Biomarkers are a bit like dynamite in that they can be extremely useful but they can cause a lot of damage," said Ross.

He cites a biomarker that suggested irregular heart rhythms were a key predictor of fatal heart attacks. Using the assumption, doctors prescribed heart-regulating drugs to millions of patients in the 1980s but abruptly halted the practice in 1989 when a long-term study revealed patients were actually more than twice as likely to die of sudden heart failure."

Note to Perrone and Ross: The reason people died was because the drug was prescribed to patients outside of the clinical trial guideline. Ross is using the "generic" definition of a biomarker, meaning biological measure that is linked to a disease state. A biomarker that captured genetic variations explaining why people more likely to die from the drug is now possible to develop using a blood test. I guess we shouldn't use that. Ditto, all those tests that can now screen to see which people respond to certain cancer drugs and avoid needless chemotherapy or which HIV drugs will work for them.

It should also be noted that Ross was one of the biggest loudmouths about the dangers of SSRIs which have been overhyped to the point that prescriptions are down and suicides are up.

This effort to eliminate measures like cholesterol, glycemic index, bone density, blood pressure as conditions of approval is just an effort to slow down drug approval and move it into the dark ages. It is being engineered by those who believe that the current approach to clinical evaluation is corrupt and corporatized. Supporters offer this more rigid and unreachable methods not because they are based on better science but because they reduce the number of new medicines that companies develop. The attack is political, pure and simple.

The battle lines are already being defined: The opponents of the Foundation and Critical Path oppose both because it might advance industry and industry is evil. (Even though most of the research will be done in collaboration with academia and NIH). Because corporations are involved it is inherently evil and corrupt. WHich allow the other side to distort the mission and the science all they want.


The headline in the WP "New FDA Research Center Rife WIth Risks" tells you that Reagan Udall has already been spun. How sick and sad is that?

http://www.washingtonpost.com/wp-dyn/content/article/2007/10/14/AR2007101400722.html  Read More & Comment...

TNR Responds to Drugwonks on SCHIP and the Family Frost

10/15/2007 08:41 AM |

I appreciate Jonathan Cohn's thoughtful response to my post on SCHIP and the Frost family being the poster for SCHIP expansion/renewal. It is obvious we have two different views of how to make health care convenient, predictive and prospective. Indeed, the fight over the bona fides of the Frost family have less to to do with their income or wealth or mine for that matter but really about whether entitlements should be expanded to cover and crowd out private insurance and whether government should be the payor and provider of health care or not.

I supported Part D -- the largest expansion of Medicare in a lifetime -- while most Democrats who supported the same approach in 1999 did not. I did because I thought that adding drug benefits would reduce health care spending overall and that giving people choice would create competition and lower costs. I have always opposed SCHIP because it addressed a problem that did not exist with a solution that made matters worse. We have 4 -5 million kids eligible for Medicaid in 2006 and that was about the same number in 1997. Meanwhile the single payer approach if you will has made it hard for people to enroll in SCHIP. All the while, we have ignored the issue of coverage for illegal workers who make up a huge chunk of the uninsured and the fact that lots of people are just to cheap and irresponsible to buy their own insurance.

But that's the heart of the debate. I think everyone should have access to health care coverage and decent care. I don't think we can guarantee results or equal outcomes and I don't think government does a great job delivering health care coverage. Cohn does. This debate is not over. SCHIP will get refunded but not expanded. And then we can have a debate about whether we want Hillary to run health care (setting up a false set of choices that lead to a single payer system) or let people decide for themselves through insurance deregulation, HSAs, tax credits and retail clinics.

I think conservative ideas on health care will win the day. Why? Because we value freedom as an essential ingredient for excellence in medical science and sustaining dignity in the doctor patient relationship. Without freedom, the freedom to innovate, to prescribe, to choose, to err, medicine suffers.

My thanks again to Mr. Cohn for reshaping the debate around what matters. Here's a link to his post and to his book about the health care system.

http://www.tnr.com/
blog/the_plank?pid=151407

http://www.sickthebook.com  Read More & Comment...

"Concerned" Scientists?

10/15/2007 08:33 AM |

Why is the Union of Concerned Scientists putting politics in front of the public health?

http://www.washingtonpost.com/wp-dyn/content/article/2007/10/14/AR2007101400722.html

Consider the statement of Francesca Grifo, a director at the UCS, “Given FDA's track record in the past, I'm not confident in their ability to create something that is free of influence from industry."

Believe it or not, this statement was aimed at, of all things, the bi-partisan crown jewel of current FDA reform legislation – the Reagan/Udall Foundation (aka “the Crtitical Path Foundation”), approved by Congress and signed into law late last month, allowing the FDA to work with both industry and academe to accelerate the nascent sciences of genomics and proteomics to help realize the very real potential of a new kind of medicine – personalized medicine -- capable of tailoring highly effective treatments against the underlying causes of specific diseases in individual patients – and perhaps even preventing those diseases from occurring or progressing in the first place

According to Senator Ted Kennedy, the Reagan-Udall Foundation "will make new research tools and techniques available to the entire research community, shortening the time it takes to develop new drugs and reducing costs for patients."

Just what track record is Ms. Gifo referring to anyway?

The hard truth is that many of the most dramatic scientific advances in basic research are difficult to translate into safe and effective medical treatments for patients. Isn’t this something that “concerned” scientists should be concerned about?

Despite the increase in R&D spending, the number of new innovative products being submitted to the FDA for approval is decreasing and the rate of failure is increasing. Almost 50% of applications are failing in late-stage Phase 3 trials. This costs companies millions of extra dollars and is driving up the cost of successfully bringing a new drug to market. In 2003, researchers at Tufts Center for the Study of Drug Development estimated these costs to be $802 million, and some sources suggest that the total cost is closer to $1.7 billion.

As the late Senator Everitt Dirksen said, “A billion here and a billion there, and pretty soon you’re talking about real money.”

Think about the millions of dollars, pounds and Euros that would be saved by all types and sizes of companies and governments if publicly discussed and vetted biomarkers could be used and used predictably in the drug approval process.

IP questions? You bet – it’s the 800 pound gorilla sitting in the corner. But we must acknowledge, address, and overcome this and other obstacles. Bumps along the road of all sizes must not allow the Critical Path to be the path less traveled.

FDA must assume the lead organizational role, because the agency is at the crossroads of the translational process. FDA is uniquely suited to take a major role in this effort because of their unique cross-industry and cross-cutting knowledge of the hurdles companies and products encounter that are causing them to fail in late stage clinical trials.

The Critical Path must be blazed in partnership. Regulators and industry, patient groups and legislators, FDA and EMEA must work together to help bridge the widening canyon between bench and bedside.

The Union of Concerned Scientists thinks the FDA has “an agenda” – and they’re right – it’s to protect and advance the public health.  Read More & Comment...

Waxman Proposes Price Controls and Restrictive Formularies To Save Money

10/15/2007 08:31 AM |

You would think Henry Waxman would have learned from the Part D debacle but here he goes again claiming that Medicare "would have saved almost $15 billion this year if the drug plans had administrative costs similar to traditional Medicare's hospital and physician coverage, and discounts on drugs similar to those obtained by the government in Medicaid, the state-federal program for the poor."

This from a "draft" obtained by Sarah Lueck of the WSJ.

http://online.wsj.com/article/SB119222916919857858.html

We all know how reliable Waxman's savings estimates are. Remember the $200 billion in savings from using the VA restrictive formulary approach and the $70 billion in savings from follow-on biologics. So here comes Waxman raking in $150 over ten years through price controls and restrictive formularies ala Medicaid.

I hope the Democrats go down the "Destroy Part D" path again. It was fun last time.  Read More & Comment...

First Sign of a Sinking Ship -- Political Expediency

10/12/2007 10:00 AM |

John McCain demonstrates his ignorance of health care in Iowa -- or maybe it's just political pandering -- you be the judge:

“Pharmaceutical companies must worry less about squeezing additional profits from old medicines by copying the last successful drug and insisting on additional patent protections and focus more on new and innovative medicine.”

Attention Senator McCain:

America’s pharmaceutical and biotechnology research companies set a new record for biopharmaceutical research spending last year with an investment of $55.2 billion to develop new medicines and vaccines. That's $3.4 billion higher than the previous record of $51.8 billion spent by U.S. companies in 2005.

The research spending of all of America’s biopharmaceutical companies is much higher than the amount spent on biomedical research by the National Institutes of Health and pharmaceutical research companies in other countries.

It may not be popular or politically expedient to admit the truth. But we expect better from Senator McCain.  Read More & Comment...

Dutch Treat Taken Off the Market

10/12/2007 07:54 AM |

Speaking of nightime cold remedies being taken off the market....

Dutch ban famed hallucinatory mushrooms

By TOBY STERLING, Associated Press Writer

AMSTERDAM, Netherlands - The Dutch government said Friday that it will ban the sale of hallucinatory mushrooms, rolling back one element of the country's permissive drug policy after a series of high-profile negative incidents.

http://news.yahoo.com/s/ap/20071012/ap_on_re_eu/netherlands_magic_mushrooms  Read More & Comment...

Cough Medicines? How About Pulling Cars From the Roads

10/12/2007 07:30 AM |

This recent Vioxx liability driven drive to yank infant cough formulas from the shelves is the latest in a series of meaningless gestures that will do nothing to make kids safer or save lives. The leading cause of death and injury among kids are car accidents. I don't see trial lawyers and their allies threatening to sue the auto companies for vehicular manslaughter. But when stupid parents OD their kids on Triaminic or Children's Tylenol for Cough and Cold somehow that's the drug company's fault. As in this case report: "n the third case report, the child tragically died from an overdose of cough and cold medications that likely had been persistently administered because of continued symptoms in the child." I know, I know, the marketing made them do it. People are brain dead until some TV ad programs them to do something lethal. Nothing before or after matters.

I predict there will be a jihad against all pediatric cough formulations soon. The "safety uber alles" crowd smells blood after this victory and won't stop. They see danger lurking everywhere because they believe drug companies have to poison people to make profits.

Risk in life is not an all or nothing proposition. Life is a series of trade-offs, balancing the bad with the good, the bitter with the sweet, etc. Learning how to handle risky situations big and small is part of growing up, becoming an adult. We are infantilizing our culture further with this sort of overreach. You can't buy Claritin-D without a driver's license (but I can buy Viagra over the internet) build treehouses anymore, can't ride a bike without a helmet, can't play soldier, can't even sell cupcakes in school anymore without have some safety nanny get between you and a good time or you and a personal decision.  Read More & Comment...

Berenson Takes A Bite Out of Dentists

10/11/2007 01:08 PM |

Why are our teeth rotting? Because dentists are making more money then ever, making teeth cleanings and cavity filling more unaffordable than ever before. That's according to Alex Berenson who wrote another article without stealing documents.

In fact Berenson buries the reason dentist salaries are going up: there is a shortage of dentists and the falling number of schools to replace the one's who will be retiring. Meanwhile the disparity in care between rich and poor is the same old story....Medicaid rates are too low and when dentists do provide care, patients rarely show up. So even if reimbursement rates are bumped up patients don't show and doctors don't get paid. That's something Berenson ignores in his attack on the profession even though the federal government sees it as of tactical importance. Here's a glimpse from a government study about the dental divide...

"A common complaint among dentists concerns patients who do not keep their appointments. Missed appointments cause resentment among dentists because of the office management and financial problems they create. More importantly, the patient does not receive a needed service. The likelihood of a patient keeping a dental appointment is improved with a system of case management that addresses the logistical, cultural and behavioral barriers to dental care. Medicaid can pay for case management as a medical service or as an administrative activity."


http://www.hrsa.gov/medicaidprimer/oral_part3only.htm

I think part of the problem is that people have gotten used to only getting care when it's paid for, not when it is necessary so they shrug off going to the dentist twice a year. Then there is the failure to brush, floss, rinse, etc.

Still Berenson's article does pick up on themes and concerns articulated in the Surgeon General's report on Oral Health in 2000. A public health solution will not work, but a retail or market driven one might. Of course the dental profession is digging it's heels in on not letting hygenists do cleanings and exams on their own. But that won't last long. My prediction: Dentistry will go the way of the retail health clinics. Cleaning, xrays and exams for $60 with evening hours.

http://www.nytimes.com/2007/10/11/business/11decay.html?_r=2&pagewanted=2&ref=health&oref=slogin  Read More & Comment...

Blog Battle Over the Frost Family: Really a Fight Over Health Care's Future

10/11/2007 10:57 AM |

Jonathan Cohn is The New Republic's leading voice in support of universal health care. He has taken issue with conservative who have criticized Democrats for using middle and upper class individuals as walking and talking posters for their efforts to increase the welfare state. Most recently conservative bloggers, including me, have taken issue with Democrats deciding to have a 12 year boy give a response to President Bush's veto of SCHIP. It seemed tacky at the time, sort of a cheap shot considering the bill Bush nixed extends government insurance to folks making $83K a year (no asset test folks!) at a time when Medicaid rolls are declining. But then I learned that picking the kid was Families USA's idea and well, the fact they have moved from lying about drug prices to dragging a family into the middle of a political fight does not surprise me at all.

So of course Cohn tries to blame "right wingers" for picking on a kid. Let's be clear. The issue is whether SCHIP should be expanded to middle income families. At least that's what Cohn is saying:

"We know that people with modest incomes are having a harder time paying their medical bills, because insurance is getting so pricey and--increasingly--the benefits available leave them exposed to high out-of-pocket expenses. We also know this is particularly true of people who can't get coverage through large employers--a class of people that is expanding as the business community slowly extricates itself from the mess of providing workers with insurance.

In other words, it's not just the most destitute Americans who need assistance getting health insurance. It's people who have jobs, make a decent living, and own their homes. And when medical crisis hits, they're forced to take drastic steps--like selling their homes, depleting life savings, declaring bankruptcy, or simply going without the care they and their loved ones need. Unless, of course, the government provides them with insurance at affordable rates. "

First of all, Cohn is immune to the facts: many people simply don't buy insurance that is affordable (and it is affordable) in many cases so they create a medical crisis in many cases.... The fastest growing segment of the uninsured are people making $70k or more and whose incomes are growing. Explain that. Meanwhile Medicaid roles are declining.

Cohn also sees health insurance as a big pre-paid security blanket. Zero deductibles. No copays. Coverage for everything. Dream on boychick. That does not even exist in France, your health care wet dream. That system is broke so Sarkozy is installing gatekeepers, co-pays, the works. Soon France will be one big HMO. Even GM's employees are cutting back. You see health care as an all you can eat buffet, not as personal responsbility.

Ultimately, Cohn misrepresents the conservative position on health care. It is not opposition to making coverage affordable. Rather, the conservative position is to take the favorable tax breaks and purchasing power corporations have and give it to individuals. So instead of SCHIP why not advanceable tax credits and purchasing pools, prefunded HSAs? Why is Cohn so opposed to that? For the same reason liberals are hysterical about declining Medicaid enrollment and opposed Part D. They want people dependent.

The fight is not about a family and whether they should have access to affordable and convenient care. That's a given. The fight is about whether Americans should be herded into a single payer system supported by Hillary, Cohn and others where the sort of high tech care Graeme Frost needs and deserves will be denied him regularly. With HSAs, tax credits and consumer choice he and his family will have control over the medical decisions that shape his life, not a bureaucrat or some comparative effectiveness institute. In Britain, Germany, Canada or even France where the doctors strike more than they see patients, Graeme would get inferior care. He would be less cared for and less valued.

In the final analysis, conservative care more about his future than Cohn, Ezra Klein and his kind ever will. Klein, Cohn and Families USA just want to expand the welfare state. I dare say my conservative colleagues want to preserve the possibilities that medical progress offer to extend life and enhance the human condition.

http://www.tnr.com/blog/the_plank?pid=150639  Read More & Comment...

Velcade Corleone

10/11/2007 09:14 AM |

WSJ blogger Peter Loftus writes, “Meter Set to Run on J&J’s Cash-Back Deal” – but it’s the meter on physician empowerment and patient choice that is already ticking.

In an attempt to get NICE to reimburse Velcade, Johnson & Johnson made the UK regulatory body an offer they couldn’t refuse – the “Velcade Response Scheme” -- a money-back guarantee for the cancer drug.

The scheme changed the equation. “For those who may get a full response or a partial response … it’s a cost-effective intervention for the National Health Service,” Andrew Dillon, chief executive of NICE, told Dow Jones Newswires. “Narrowing down to patients getting the best response makes it worth it.” A government proposal formalizing the deal is expected to become final on Oct. 24.

But the measures of “success,” are debatable. A “response” would be considered to be when a patient achieves a 50% or more overall reduction in their paraprotein after four cycles of Velcade. Only patients who achieve this 50% plus reduction in their paraprotein will continue on Velcade. No rebates will be issued for patients who achieve a full or partial response. Also, the drug is recommended only for people who are having their first relapse, who have received one prior therapy and who have undergone a bone marrow transplant or have been deemed unsuitable for a transplant.

Non-responders at 4 cycles will not have the option of continuing therapy because NICE does not consider that there is sufficient clinical evidence to show that those patients who have not responded well after four cycles, would gain any benefit by having four further cycles. Hmm.

Loftus write that, “The Velcade rebate program is the first of its kind in the U.K. and may be a harbinger of things to come there and elsewhere.”

Translation – “in the United States.”

In a matter of weeks, J&J is expected to be on the hook for the full cost of Velcade treatment for multiple myeloma patients who don’t improve "sufficiently" after four cycles of treatment with medicine.

But just what does “sufficiently mean? What type of "evidence" should be used? And who defines it, physicians or the government? That question has been asked and answered in Great Britain.

There may very well "always be an England," but there won't always be the drugs you need to survive if you live there. Welcome to the world of heathcare technology assessment aka comparative effectiveness aka evidence-based medicine.

When it comes down to brass tacks, what all these fancy phrases means for patients is "sorry -- no medicines for you." So much for "universal" health care. "Government" health care is more like it  Read More & Comment...

Medicaid Enrollment Declines: Liberals Propose Solutions To Reverse Escape From Dependency

10/10/2007 05:22 PM |

You would expect fewer people to be on Medicaid with a growing economy even after a decade of hectoring people to sign up government run health care...but people actually leaving an entitlement especially when liberals are trying to override a presidential of SCHIP expansion to cover people making $83k with billions in assets....

So unfair.

Which explains why the Kaiser folks are getting a bit nervous about the latest data showing a decline in Medicaid enrollment and translated into some, uh, confused explanations for the drop in program participation...

"Enrollment in Medicaid declined for the first time in nearly a decade, according to a new 50-state survey released today by the Kaiser Family Foundation’s Commission on Medicaid and the Uninsured (KCMU). But faced with an improving economy, 42 states expect to expand coverage to the uninsured in the next year.

The survey reports a 0.5 percent enrollment decline in fiscal year (FY) 2007 driven primarily by two factors. States reported that the new documentation requirements were causing significant delays in processing applications, affecting mostly individuals already eligible for the program. State officials also cited the good economy and lower unemployment for reducing enrollment."

Yeah, those new documentation requirements. That explains it. Never had paperwork in the Medicaid program before.

And how do you expand coverage to the uninsured when a good economy reduces unemployment and enrollment?

http://www.kff.org  Read More & Comment...

Two Doses of Political Micromanagement on ESAs

10/10/2007 08:50 AM |

Want a peek at how comparative effectiveness decisions will go down in the American political system? The response to arbitrary CMS decision to ration EPO use in cancer care is a case in point. Member of congress have introduced legislation to override the decision (the Sec of HHS can't) in an effort to pressure CMS to step back. This is not the first time that Congress has mandated coverage of a specific type of care in response to an administrative decision and lobbying.

We think that the CMS decision is a power grab designed to turn CMS into NICE. So it's ironic that it is Senator Baucus -- the advocate of comparative effectiveness in the Senate -- who introduced legislation to slap down the CMS decision that itself was a product of evidence-based, cost-effectiveness analysis!. But it just goes to show you that if you think that technology assessment is objective and not political, think again.

I don't like political micromanagement even when I support the position of the micromanager. CMS should do the right thing and provide continuing coverage of ESAs while conducting a post market search for who benefits most and least from ESAs and why. That's real comparative effectiveness.  Read More & Comment...

Warfarin and Peace

10/09/2007 06:58 AM |

In case you missed the excellent article by Matt Herper and Bob Langreth in Forbes, here are a few sample paragraphs and a link to the complete piece:

Genetics' Super Summer

The hunt for new genes has suddenly gone into overdrive.

Between the end of May and the beginning of September, scientists discovered telltale genetic markers that help predict the risk of nine major diseases, including breast cancer, multiple sclerosis, rheumatoid arthritis and heart disease. Some of these newly discovered markers will be used soon in diagnostic tests; others will help researchers better understand the diseases in order to invent new treatments.

One use for new gene tests that is likely to come fast is in predicting which patients will be helped or harmed by a particular drug. This summer, a Pfizer AIDS drug, Selzentry, is approved only for patients who carry a particular version of an immune system gene, CCR5. The Food and Drug Administration is expected to approve more drugs only for use with people with particular genes, and is drafting guidelines for companies. Clinical Data , the latest effort from billionaire biotech investor R.J. Kirk, is being built around the idea of pairing drugs for depression and schizophrenia with gene tests.

An iffier area is predicting who will benefit or be hurt by a long-existing drug. The FDA added guidance suggesting the use of a gene test in picking the right dose of the blood-thinner warfarin, which is life-saving at the right dose but causes dangerous bleeding if a patient gets too much. Another promising area is the use of a gene test to keep from giving antidepressants to patients who might get suicidal thoughts from the medicines. But often these new findings aren't tested as rigorously.

Here's a link to the complete article:

http://www.forbes.com/sciencesandmedicine/2007/10/01/genetics-disease-cancer-biz-sci-cx_mh_1002genetests.html

The article's final sentence reads as follows, "Janet Woodcock, the FDA's chief medical officer, predicts "a lot of scientific uncertainty."

Indeed. But the Critical Path must not be the one less traveled. Because that will make all the difference.  Read More & Comment...

Rostafarian Referral

10/08/2007 10:58 AM |

Peter Rost and I do not agree on many things, but here's something we both seem to appreciate -- a good laugh that makes you think.

Such is a "must see" photo and caption titled, "Some People Just Don't Get It." Made me smile ... and then grimace.

Worth a look at http://www.brandweeknrx.com

Peter -- why don't you link to us?  Read More & Comment...

Health Care to the Max

10/08/2007 07:04 AM |

Grace-Marie Turner, Galen’s Grande Dame reports that ...

“In Rome last week, I debated Italian politicians on national radio, tried to explain our health system to government and industry leaders, and spoke at a conference at the Vatican about the fundamental values of health care and the common good.

Some take-aways: Europeans truly believe that we have a permanent underclass in the U.S. of 47 million poor citizens who have absolutely no access to health care. They are shocked at how barbaric we are and that any civilized country would tolerate such a thing. When I tried to explain the facts -- through a translator -- to an Italian senator on RAI radio, he was incensed.

He didn't want to hear that we spend nearly as much as a percentage of our GDP on public programs -- to cover about one-third of our people -- as many European countries spend of their GDPs in total on health care. Or that almost half of our more than $2 trillion in health expenditures are primarily through these public programs that cover the poor, the aged, the disabled, veterans, and lower-income children. Or that many of the uninsured are temporarily without coverage in a system that ties health insurance to the workplace. Or that the uninsured do get care -- albeit in a far from ideal system -- through hospitals, private physicians, community health centers, charity clinics, and other means. Or that Americans value private coverage with its broader access to new technologies and medicines and faster access to surgeries and treatments.

It seemed almost as if he wanted people to believe that there is nothing at all to be learned from Americans so as not to crack the veneer of socialized systems.”

Attention must be paid by American officials – particularly by thoughtful legislators such as Senator Max Baucus (the Chairman of the Finance Committee -- with jurisdiction over the major public health insurance programs) -- whose “five broad principles of reform” are, whether you agree with the basic premise or all or none, worthy of intense scrutiny and robust debate. They are:

Universal coverage. (“We cannot address the health care system, and leave a growing portion of the country behind. Though this much be a public and private sector mix.”)

Sharing the burden. (“The way to ensure affordable coverage is to create pooling arrangements.”)

Controlling costs. (“Any serious proposal must reduce the rate of growth of health care costs.”)

Prevention. (“By making prevention the foundation of our health care system, we can spare patients needless suffering. We can avoid the high costs of treating an illness that has been allowed to progress.”)

Shared responsibility. (“Health coverage is a shared responsibility and all should contribute.”)

Note: Parenthetical quotes come directly from Senator Baucus' website.

The one thing we should all be able to agree upon is that there are no easy solutions … America’s SiCKO Apologists notwithstanding.  Read More & Comment...

The World's Top Medicine

10/05/2007 12:35 PM |

Here's Marc's piece...

THE WORLD'S TOP MEDICINE
By MARC SIEGEL


October 5, 2007 -- CRITICS of the U.S. health-care system point to the 100,000 or so Americans who go overseas for treatment each year, typically citing lower costs. Fair enough - but they should also consider why 70,000 foreigners a year come here for medical care.

America has better tools of diagnosis and treatment than any other nation. Consider one of my patients - Paul, an American professor living in Europe.

Paul fell and smashed his wrist in 2002; the blood supply to the joint was compromised. He was operated on in New York by Charles Melone - the same highly successful hand surgeon who had also fixed the limbs of Patrick Ewing, Don Mattingly and Zaro the baker. Afterward, proudly flexing his wrist, Paul proclaimed Europe's "no frills" system as his "health care of last resort."

In 2003, Paul developed an elevated prostate test (PSA). I urged him to return to New York for a biopsy, to rule out prostate cancer. But he couldn't afford the trip or the procedure. He was living in Copenhagen, and the doctors there told him they thought the abnormal result was due to benign prostatic hypertrophy, not cancer.

Only in late 2005, as his PSA continued to rise, was I finally able to convince Paul's Danish urologist to perform the biopsy. The results were normal - but it was a "no-frills" biopsy with only four samples taken, half what's usual here.

Sure enough, Paul's PSA rose even higher, and he began to have more trouble urinating. He finally had the biopsy repeated in Greece (where he now lives) this summer - and it was positive for cancer in both lobes of the gland.

Paul's doctors in Greece recommended immediate radical prostatectomy to remove the diseased prostate. After Paul called me, I contacted Dr. Herb Lepor, the chairman of urology at NYU, who has done more than 3,000 of these procedures and is a pioneer of the nerve-sparing technique that helps preserve sexual function. Lepor said he didn't know of a surgeon as specialized and experienced in Greece.

Unfortunately, Paul's European insurance wouldn't cover an American operation, and Paul could no longer afford it (he'd barely been able to afford the wrist work years before). Instead, he had to settle for a local surgeon at the state hospital in Athens (who came well recommended by other Greek doctors and patients). The operation is next week, and I nervously await the result.

Paul's insurance will cover everything, so his choice seems reasonable - but far from perfect. The latest study shows that survival rates after five years with prostate cancer are 77.5 percent in Europe, versus 99.3 percent here.

One more anecdote: I arranged the medical care for the prime minister of a large Asian country during his recent diplomatic mission here. His personal physician from home stood idly by as the patient visited one top U.S. specialist after another. The PM ended his visit waiting behind another Asian prime minister for a special brain procedure they both knew they could never get back home.

Dr. Marc Siegel teaches at the NYU School of Medicine.  Read More & Comment...

Chronically wrong about what's wrong with heatlh care

10/05/2007 12:23 PM |

I was in Israel visiting my son and had limited access to news and the internet. Of course I return to see the Yankees took a pounding and the same sloppy causality that fits pre-existing biases in health exist.

Leave to Health Despairs to claim that the major reason the US spends more on health care is because we are sicker. Confusing diagnosis (which is a function of being able to see a doctor multiplied by what the doctor can do time what the doctor gets paid for) for prevalence Ken Thorpe et al. claim that at least part of the underlying difference in prevalence is poorer health status. Really? He goes on to estimate that the prevalence of diagnosed cancer was 12.2 percent in the United States but only 5.4 percent in Europe in 2004. A huge difference. Even Thorpe has to write: "Are Americans really more likely to develop malignant tumors, or are they just screened more intensely than Europeans are? Comparisons of breast cancer screening rates and five-year cancer survival rates suggest the latter"

So of course I and Marc Siegel, who wrote just a brilliant op-ed in the NY Post that puts a human face on all this, (namely, there is widespread rationing plus a conservatism and passivity in European patients you woud NEVER see here or in Israel for that matter) get emails from ABC news asking about the Health Affairs piece about why Americas are sicker than Europeans....

Why not just do a re-run of Sicko and get it over with instead of looking at the facts.  Read More & Comment...

The Next Gatekeeper

10/05/2007 08:14 AM |

Kate Rawson of RPM has written a must-read omnibus on the current state of affairs vis-a-vis comparative effectiveness.

Here's a link ...

http://cmpi.org/archives/2007/10/rpm_report_discusses_groundbre.php

And here's a snippet about a NICE-like body in the US provided to provoke your perspicacity ...

"Some policy experts object to the idea of a center being tied to a government agency because of the inherent bias of the funder (the government) making research decisions to save the payor (the government) money."

See for yourself. A very worthwhile read.  Read More & Comment...