See Dick write ... and run?

06/10/2010 08:11 AM |

Here’s an excellent article by Dick Gephardt.  Remember Dick Gephardt?  Smart guy with an important message.  Buzz is that he may be sharing this message from a more prominent perch in the near future.  But buzz, as you know, often turns out to be just that.

In any case, enjoy this article (from Politico):

Medical innovation is economic key
By: Dick Gephardt

As Washington searches for solutions to continue our nation’s economic recovery, it’s time to cultivate new growth strategies.

Medical innovation should be key. It can create millions of high-paying jobs, increase our global competitiveness and help reduce our nation’s growing deficit.

Experts project that the health care sector will generate 3 million jobs from 2006 to 2016, with significant growth due to medical innovation. From lab coats to hard hats, medical innovation creates an array of high-paying positions across academic disciplines, management fields, health services and skilled trades.

Much of the promise from medical discoveries, new technologies and cutting-edge procedures is a direct result of America’s longtime leadership in medical innovation. Yet global leadership is now ours to lose unless we make a national commitment to needed strategic and sustained investments and partnerships to keep the U.S. competitive.

For medical and life sciences, research can transform local economies. Even in Michigan, which has seen serious job losses in many sectors, the number of people working in life sciences increased by more than 10 percent between 1999 and 2006. Average wages jumped 29 percent.

In Iowa, medical schools and teaching hospitals have a combined economic impact of $4.1 billion, according to the Association of American Medical Colleges. In Virginia, the economic impact is $9.9 billion. In Ohio and California, it is $27.2 billion and $41.6 billion, respectively.

One need only look to the Cleveland Clinic to see what’s possible. In addition to its world-renowned health care, the Cleveland Clinic has helped launch more than 200 cutting-edge inventions per year . It has spun off 24 separate companies in the past decade.

Cultivating this sort of activity on a national scale can spur new businesses and establish a truly 21st-century work force, fueled by the skilled workers and increased productivity that are byproducts of continued innovation.

Today, many experts suggest that we could forfeit our leadership if we do not address the challenges that have emerged. We are plagued with a shortage of capital and arbitrary limits on private investment. The U.S. Food and Drug Administration’s approval process is lengthy, costly and presents more uncertainty for struggling entrepreneurs.

Worst of all, our talent pool is shrinking. The U.S. ranked 16 out of 29 Organization for Economic Cooperation and Development countries in science literacy, according to the latest scorecard from the National Center for Education Statistics, and 24 out of 29 OECD countries in mathematics.

We must do more to produce the next generation of highly educated scientific innovators. And we must train and retrain students and adults for jobs to support medical innovation.

With high unemployment and skyrocketing deficits, we need a national strategy that will help us innovate our way out of our current economic crisis and create a path that ensures long-term opportunities.

This strategy could draw on the best of what we’ve learned from public and private sectors. It would create incentives for sustained public and private investment in medical research, education and training.

It would encourage public policies that spur technology transfer, appropriately protect intellectual property and help attract venture financing at all stages of research and development. It also would establish a tax and regulatory climate that encourages private enterprises — large and small — to participate in medical innovation.

For more than a century, the U.S. has been synonymous with medical discovery and achievement. This excellence has dramatically improved our quality of life, driven our ability to compete globally and created countless new domestic employment and economic opportunities.

Let’s make the decisions and investments necessary to continue to reap the enormous economic and human benefits made possible through medical innovation.

Dick Gephardt, former House majority leader, is now president and chief executive officer of Gephardt Government Affairs and serves as chairman of the Council for American Medical Innovation.

 

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Hard Sell on Healthcare and Health IT

06/08/2010 03:01 PM |

Let's have some new cliches.
Samuel Goldwyn

A recent article in Health Affairs tries to prove what we all knew: there were cheaper, better ways to reform healthcare but political realities got in the way.  The article:

"Could We Have Covered More People At Less Cost? Technically, Yes; Politically, Probably Not", concludes using a mathematical model believe it or not  that shows  only a few different approaches would produce both more newly insured people and a lower cost to the government. However, these are characterized by design options that seemed political untenable, such as higher penalties, lower subsidies, or less generous Medicaid expansion.

A few means more than two, so let's say five different aproaches.  What made them politically untenable was not the burden it would place on taxpayers but the fact that politicians wanted to increase government control to the fullest extent possible.  

Now what if the November elections become a vote on Obamacare and a new Congress reforms the current law to reduce the cost and government control?

You can read the abstract of the article here:  content.healthaffairs.org/cgi/content/abstract/29/6/1142

Meanwhile the Health IT community is still  trying to convince doctors that spending billions on new systems will improve quality and reduce costs even as physician payment under Medicaid will be slashed and reporting requirements will multiply.    It seems to me that the only valuable contribution health IT can really make is to allow doctors and patients to improve health by the development of personaized and predictive approaches to care and paying for that approach.  The rest is simply like remodeling a restaurant to look trendy and assuming it will increase the chef's ability to produce five star meals for twice as  many customers even as his salary and food budget are cut in half.   So much of health It is not only beside the point but created to establish new approaches to delivering care that have nothing to do with how medicine is practiced, or should be. 

 

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Man, Superman -- and IPAB

06/08/2010 07:05 AM |

My recent op-ed on the new Independent Payment Advisory Board (IPAB) generated a lot of comments – and a lot of corrections. And so, in the spirit of transparency and disclosure and (most of all) thanks, here are some important emendations

  

1. In the article’s fourth paragraph, the last sentence reads, "And the IPAB's policy recommendation automatically will be institute unless Congress overrides them."  Technically, it will be implemented automatically unless Congress comes up with its own proposal that meets the same spending cut targets.  Congress can also (with 3/5 majority in both houses) pass a resolution rejecting the IPAB proposal, but that can be vetoed by the President and would then be subject to a 2/3 override. I oversimplified.  Mea culpa.

 

2. Sixth paragraph, second sentence reads, "For one, it doesn't have any authority over the biggest cost-drivers in Medicare."  I stand corrected.  IPAB cannot make recommendations (before 2019) that would "reduce payment rates" to Medicare Part A providers or Part B suppliers.  However, IPAB could nevertheless make recommendations with respect to those entities that would have the effect of implementing policies that would be viewed as unfavorable or harmful by those entities (or beneficiaries that rely on Parts A and B.)  For example, IPAB could utilize the LCA policy for Part B drugs, establish a Part B national formulary, etc.

 

3. Ninth paragraph, first sentence reads, "Yet the IPAB has no power over Part A or Part B."  While the IPAB cannot make recommendations to cut provider payments in Part A or B before 2019, but that does not mean they have no power over providers in Part A and B and in fact that there are lots of recommendations they could come up with that impacts these providers without cutting their payment.

 

4. Eleventh paragraph, first sentence, "The IPAB can make drastic changes to Medicare plans, including raising premiums, cutting benefits, and restricting eligibility requirements."  Let me clarify. There is a prohibition on recommendations that would increase Medicare beneficiary cost-sharing (including deductibles, coinsurance and copayments) or otherwise restrict benefits or modify eligibility criteria – but the prohibition on raising premiums does not apply to Part D - but these other prohibitions do (rationing, cutting benefits and restricting eligibility.

As George Bernard Shaw wrote, “A life spent making mistakes is not only more honorable, but more useful than a life spent doing nothing."

And many thanks to all you drugwonks out there for the smart and savvy corrections. The devil is in the details.

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Personalized Medicine Is Picking Up Steam

06/07/2010 03:30 PM |

These two articles demonstrate the importance of commercialization in addressing the clinical and logistical barriers to personalized medicine. 

Medco, CVS Caremark Gear Up to Expand Genetic Testing Management Services


www.aishealth.com/Bnow/hbd060710.html

23andMe Partner to Provide Genetic Counseling

www.genomeweb.com//node/942414


This  movement will be the counterweight to one size fits all comparative effectiveness...
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White House Misleading On Health Reform Information

06/07/2010 03:18 PM |

According to the Politico

Former Senate Democratic leader Tom Daschle and Victoria Kennedy, the late senator’s wife, are expected to be named co-chairs this week of a $125 million campaign White House allies are rolling out to defend health reform amid growing signs the party is failing to get political traction on the issue.

 

The extraordinary campaign, which could provide an unprecedented amount of cover for a White House in a policy debate, reflects urgency among Democrats to explain, defend and depoliticize health reform now that people are beginning to feel the new law's effects.

 

The Health Information Center is being started by Andrew Grossman, a veteran Democratic operative who founded Wal-Mart Watch, a labor-backed group to challenge the world’s largest retailer.

Even without issuing one press release, this "Health Information Center" misleads by ripping off the name of a "National Health Information Center" which is run by the federal government.  

Here is the link to the site www.health.gov/nhic/.  According to the site NHIC puts health professionals and consumers who have health questions in touch with those organizations that are best able to provide answers. NHIC was established in 1979 by the Office of Disease Prevention and Health Promotion (ODPHP), Office of Public Health and Science, Office of the Secretary, U.S. Department of Health and Human Services.

NHIC also provides key support for the healthfinder.gov Web site, your gateway to reliable consumer health information.

And what does the new Health Information Center funded by cash raised by the Democrats claim to do:
 

The center’s rollout is part of a Democratic Party-wide effort to bolster support for health reform as the provisions begin kicking in.

 

Democrats and the White House will hold more than 100 simultaneous events nationwide as President Obama plunges back into health reform, selling the historic plan all over again as its provisions kick in. More than 10,000 people will be on the phone with the president as he holds a “national tele-town hall” meeting, 22 minutes from the White House at the Holiday Park Multipurpose Senior Center in Wheaton, Md.

This is, as noted above, an effort to "depoliticize" the implementation of the new health care law. 

Which is why you want to call the propaganda effort THE HEALTH INFORMATION CENTER and not the Campaign to Neutralize Healthcare As An Issue In The Midterms Center

Calling it the Health Information Center reminds me of the restaurant Eddie Murphy worked at in "Coming to America"  named McDowells.  Cleo McDowell who runs the restaurant explains why McDonalds might have a problem with the name:

"Me and the McDonald's people got this little misunderstanding. See, they're McDonald's... I'm McDowell's. They got the Golden Arches, mine is the Golden Arcs. They got the Big Mac, I got the Big Mick. We both got two all-beef patties, special sauce, lettuce, cheese, pickles and onions, but their buns have sesame seeds. My buns have no seeds."

(I couldn't find the clip of this scene on youtube but here's another slice www.youtube.com/watch)

McDonald's. McDowell's.  National Health Information Center.  Health Information Center.  What's the difference, right?

Oh, and there is also a Health Information Center on the web.  www.healthinfocenter.org  

If you have to hide what you really are and what your real goals are, how can the NATIONAL HEALTH INFORMATION be trusted?  
 

 

Read more: http://www.politico.com/news/stories/0610/38199.html#ixzz0qC8awJUU

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Birth of a Notion

06/07/2010 09:07 AM |

The buzz at ASCO is about more (and more expensive) personalized treatments – but the word on everyone’s lips is “diagnostics.”

And the question is whether FDA is going to be part of the problem or of the solution?

As the science of biologics necessitated the agency’s invention of CBER, so too does the promise of "personalized medicine" demand a new FDA bureau to further the development of 21^st century diagnostics.

As CDER begat CBER so too must CDRH bring forth a new progeny.  Let’s call it the Center for Diagnostics Advancement.

And let’s end the unfortunate ambiguity over the regulatory pathway for diagnostics.

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Animal Magnetism

06/04/2010 09:32 AM |

FDA and NIH have launched a new website for reporting safety data.

The hope is that the Safety Reporting Portal (SRP) will streamline the process of reporting product safety issues to the FDA and NIH, with manufacturers, healthcare professionals, researchers, public health officials and consumers all able to submit an online safety report.

Currently, the site can be used to report safety problems relating to food (both human and animal), animal drugs as well as adverse events occurring on clinical trials involving human gene transfer.

Consumers can also report problems regarding pet foods and pet treats.

The website will eventually allow for safety problems with other clinical trials to be reported, as well as encompassing safety issues from products regulated by a broad array of federal agencies, such as the Environmental Protection Agency (EPA).

The FDA said it sees the site as the "first step toward a common electronic reporting system that will offer one-stop shopping, allowing an individual to file a single report to multiple agencies that may have an interest in the event."

Organizations and individuals in certain professional roles, including drug manufacturers, researchers and food manufacturers, may be required by law to submit safety reports.

"The portal will be a key detection tool in improving the country's nationwide surveillance system and will strengthen our ability to protect the nation's health," said FDA commissioner, Margaret A Hamburg. "We will now be able to analyze human and animal safety-related events more quickly and identify those measures needed to protect the public."

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Over there

06/04/2010 08:27 AM |

Send the word.  Send the word.  Over there.

From today's edition of Britain's Daily Mail:

NHS 'preparing to cut millions of operations': Patients will lose out to ensure £20bn savings

Millions of patients face losing NHS care as bosses prepare to axe treatments to make £20billion of savings by 2014, a top doctor has warned. Among procedures being targeted by health trusts are hernias, joint replacements, ear and nose procedures, varicose veins and cataract surgery.

Dr Mark Porter, chairman of the British Medical Association's consultants committee, warned NHS bosses wanted 'wholesale reductions in budgets'.

He said primary care trusts - which commission care - are already compiling lists of 'low value' operations that would no longer be provided.

These include hip replacements for obese patients and some operations for hernias and gallstones. Procedures for varicose veins, ear and nose problems including grommets in children are also not funded in some areas.

Dr Porter said it was wrong to impose blanket bans on such procedures when some patients might benefit.

Although the Government has pledged to defend spending, trusts are preparing for a period of 'unprecedented retrenchment' to make the £20billion savings within four years, he said.

'Already NHS commissioners are drawing up lists of health interventions that must be decommissioned. Cut. Stopped. Not done any more.

'These lists are clothed in the language of evidence but they represent target reductions based on cost and volume, sometimes ignoring the potential benefit to individual patients.

'Instead, in the quest for wholesale reductions in budgets, lists of banned treatments are being compiled. This is wrong.'

Dr Porter told the BMA's annual consultants conference that hospital doctors would stand up for patients.

Earlier this year the Government's rationing body said more cuts in medical treatments are planned to save the NHS at least £600million.

Patients could find it harder to get into hospital under plans from the National Institute for health and Clinical Excellence, which advises on drugs and procedures to be funded.

Chief executive Andrew Dillon said a review of clinical guidelines will be finished by the end of the year, which will include 'evidence of overuse' of treatments to 'see what the prospects (for savings) might be'.

Nice will also push through 150 changes to medical practice aimed at saving money, from reducing prescribing of antibiotics by GPs to delaying some prostate cancer tests.

A Department of Health spokesman said: 'Savings will be implemented in a way that does not affect the quality of services and all savings will be reinvested back in the NHS.'

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Dartmouth Dissected

06/03/2010 03:55 PM |

I have had my issues with the NYT but this article on the shaky conclusions and self-dealing nature of the Dartmouth Atlas group knocks it out of the park.

www.nytimes.com/2010/06/03/business/03dartmouth.html

Now the question is, what role does Don Berwick have in enabling the perpetuating the Dartmouth machine?  Has he consulted for Dartmouth or any of it's holdings?  Have they paid him any honoraria, covered his expenses for any event.  Has he used his connections to open doors for them and did he get anything in return? We know he is close to the Wennbergs and others in the Dartmouth empire.  The vice president of his own group, the Institute for Healthcare Improvement serves on the board of the Health Dialog funded Foundation for Informed Medical Decisionmaking.

The conflict of interest game is played both ways...
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A Third Leg to Stand on?

06/03/2010 12:23 PM |

Those who call for FDA to adopt comparative effectiveness as a regulatory third leg are laser-beam focused on cost effectiveness. What's important is to understand the unintended consequences of such rhetoric on pharmaceutical innovation.

For a brief lesson on the environment in which innovation operates, see here.

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The Berwick Chronicles

06/02/2010 10:26 AM |

The Politico and Special Report With Brett Baier pick up on the Berwick love affair with the NHS.  Stay tuned to our next installment that discusses how the self-proclaimed quality expert helped the UK health system into the ground. and how his 100000 lives campaign was mostly hot air

.. http://dyn.politico.com/printstory.cfm?uuid=F0EC9357-18FE-70B2-A84DFD53A9884286  Read More & Comment...

Bending the Curve

06/02/2010 10:08 AM |

CBO Director Doug Elmendorf has posted the slides he used in a presentation on May 26th to the Institute of Medicine, titled "Health Costs and the Federal Budget." The presentation directly addresses the implications of the new laws on federal health spending and the budget.

Dr. Elmendorf's slides can be found here. Worth a look.

Death by PowerPoint indeed!

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Just don't ask about the end point

06/01/2010 08:27 AM |

... or the p value.

According to the results of two studies set to be presented Tuesday at the American Urological Association's annual meeting in San Francisco, an experimental spray improved sex for some men who regularly experience premature ejaculation,

Men who applied the aerosol spray, a mixture of the anesthetics lidocaine and prilocaine, reached orgasm a mean of 3 minutes 18 seconds after beginning sex, compared with about 56 seconds for those who got a placebo spray. The 539 men completing the two studies, who were randomly assigned to the real drug or the fake version, had an average time of less than 36 seconds before they took part in the research. That meant the drug was linked to a 5.5-fold increase in time before ejaculation, compared to a 1.6-fold gain for the placebo.

The spray, currently referred to as PSD502, hasn't won regulatory approval to be marketed. The company that owns rights to the product, Japan's Shionogi & Co. Ltd., says it hopes to apply to the Food and Drug Administration and is already in discussions with the agency.

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Northern Exposure

05/28/2010 08:30 AM |

From the Toronto Star:

 

Ontario is open to tinkering with drug co-payments for seniors and others on taxpayer-funded pharmacare programs as it looks for ways to curb the rapidly increasing cost of health care, Health Minister Deb Matthews says.

 

Doctors could also see more efforts to nudge them from a fee-for-service payment model to salaries, Matthews said Thursday in the wake of a TD Bank report warning of the “serious fiscal challenges” facing medicare.

 

The report said half of government spending on drugs goes to seniors with higher incomes, and suggested the wealthiest seniors get no drug coverage – an idea Matthews flatly rejected.

 

But while the minister said taxpayer-funded drugs for seniors, the disabled and welfare recipients would continue under a Liberal government, co-payments for seniors could change based on their income levels.

“We have a bit of that now. There are different premiums and co-pays for people at different income levels,” Matthews told reporters.

 

“Have we got that right? Is it something we should look at? Sure, I think it’s something we can look at.”

Under the current system, senior citizens with incomes above $16,018 a year and couples with a combined income above $24,175 now pay their first $100 in prescription costs, and after that may pay up to the maximum of $6.11 in dispensing fees for each prescription.

 

Seniors with incomes below those levels may be asked to pay up to $2 for each prescription.

 

The TD report called for “bold” changes because at the current rate of growth, health care costs would eat up 80 per cent of the government’s program spending by 2030, compared with 46 per cent now and 30 per cent in the 1990s.

 

“We need to have the conversation about the future of health care in Ontario,” said Matthews, echoing a line she has been using for months as the government has moved, as first reported in the Star, to tie hospital funding to services provided to patients and to link pay for hospital executives to patient outcomes.

 

Doctors should be paid more on a salary basis instead of on a fee-for-service basis to make them “better able to consider the cost-effectiveness of their treatment decisions,” said the TD report by well-known economists Don Drummond and Derek Burleton.

 

“I think that is something we should continue to really look at,” said Matthews, pointing out that many doctors on family health teams and in hospital emergency rooms are now on salary.

 

Speaking for doctors, the Ontario Medical Association said it is reviewing the TD report and recognizes the sustainability of health care funding is a “crucial issue.”

 

“We know that there is still more work to be done,” association president Dr. Mark MacLeod said in a statement, welcoming a public debate on reforming the system while protecting the interests of patients.

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From iPad to IPAB

05/27/2010 08:11 AM |

Is there an American who doesn’t know what an iPad is?  More importantly, there are too many who don’t know about IPAB – the newly formed Independent Payment Advisory Board.  That’s about to change.

Read all about it in this new op-ed appearing in today’s edition of the Atlanta Journal-Constitution.

Medicare payment board needs a fix

By Peter Pitts
May 26, 2010

Those who opposed the health care bill are debating whether “repeal and replace” should be the clarion call in the coming election. Regardless of how this debate turns out, those in favor of doing better should focus their immediate attention on identifying and fixing the most harmful parts of the bill. The new Independent Payment Advisory Board, or IPAB, should be a top target.

The bill that passed restructures the existing federal agency responsible for bringing down Medicare costs — the Medicare Payment Advisory Commission, or MPAC — and turns it into the IPAB.

MPAC was a group of medical experts appointed by Congress that provided nonbinding recommendations on ways to cut expenses and increase revenues in the Medicare program.

The changes embodied in the IPAB are meant to make the agency more independent and to skirt the political hurdles that have stalled cost-control efforts in the past. Board members will now be appointed by the president. And the IPAB’s policy recommendation automatically will be instituted unless Congress overrides them.

The goal of reigning in Medicare expenses is a worthy one. As is, the program’s costs are spiraling out of control: Medicare is projected to accumulate a $38 trillion budget shortfall during the next 75 years.

But this version of the IPAB likely will prove ineffectual. For one, it doesn’t have any authority over the biggest cost-drivers in Medicare.

Medicare Part A, for instance, is so expensive its reserves will be empty by 2017, according to the Medicare Trustees. Part A covers in-patient hospitals stays. By 2035, the program’s revenues will only finance about half of promised benefits.

Medicare Part B, which covers out-patient services, has similar cost problems. Administrators just raised Part B premiums on nearly a quarter of beneficiaries because expenses have gotten so high. And an analysis from the Congressional Research Service found that without substantial hikes in Part B premiums, the program’s finances are “at risk of exhaustion.”

Yet the IPAB has no power over Part A or Part B. They’re both left to keep hemorrhaging money, soaking up taxpayer dollars and compromising the economy. Lawmakers need to push to expand the agency’s purview so it can address the real causes of Medicare’s ballooning costs.

There’s also a risk that IPAB will be insensitive to the needs of Medicare patients. After all, board members are unelected appointees with an incredible amount of power. The IPAB is liable to enact cost-cutting measures that might sound good in the board room, but actually lead to worse health outcomes for Medicare patients and strap them with unbearable costs.

The IPAB can make drastic changes to Medicare plans, including raising premiums, cutting benefits, and restricting eligibility requirements. Technically, Congress can cancel any such changes by passing a joint resolution within a month of their proposal. But Congress is so fractured that it’s very unlikely there will be the political will for such a move.

There need to be substantive checks against the IPAB decisions. And seniors need to be guaranteed representation during the policymaking process.

If left unaltered, Medicare could literally bankrupt this country. This IPAB is a step in the right direction, but it needs improvement. By pushing for some simple, commonsense modifications to the IPAB, those in favor of doing better could substantially bring down health care costs and improve coverage for millions without compromising their principles.

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NICE Exfoliation

05/26/2010 07:45 AM |

According to a report in London’s Daily Express ...

 

LEADING cancer experts were furious last night after yet another drug to extend the lives of patients (Nexavar) was refused on the NHS.

 

The decision by the Government's drugs rationing body NICE means patients with advanced liver cancer are the only ones in Europe not to have access to the sole treatment that could help them.

 

In some cases, the drug can enable sufferers to live for several years. Experts said there is no good reason why the hundreds of people who require the treatment should be denied the drug.

 

Their outrage was further fuelled yesterday by the disclosure that one NHS Trust is offering a £22,000-a-year salary to someone to remove hairs from transgender males who want to appear more feminine.

 

Karol Sikora, professor of cancer medicine and medical director of CancerPartnersUK said: "Today's decision is yet another kick in the teeth for patients, their families and the medical community.

The full Daily Express story can be found here:

http://www.dailyexpress.co.uk/posts/view/177208

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Adjusting Views on Pathway Genomics

05/25/2010 02:52 PM |

I tend to agree with the views expressed by Steve Murphy over at   thegenesherpa.blogspot.com/.       My previous posts were a reaction, not a thoughtful response to, the FDA decision to ask Pathway a lot of questions that address whether the public benefits of distributing gene tests through Walgreen's (still a good business model I believe) outweigh the risks and whether the tests are both reliable and easy to interpet and apply in a clinical setting. 

I sympathize with those who say "it's my DNA" and I should do what I want with it but if you apply that logic to anything in life without some guideposts and limits, it leads to anarchy.   Saying it's "my DNA" is actually like saying it's my way of doing arithmetric.   If there is no way to validate my conclusions and apply them to the real world in a standard format chaos ensues.

My feeling, after reading Steve's post and discussing the launch with real doctors and geneticists, is that the  path for Pathway needs to be more clearly marked to lead to personalized medicine but that it should be a path in the future.

Here is Steve's  thoughtful and science-based take: thegenesherpa.blogspot.com/

Monday, May 24, 2010

DTC Genomics reviewed in Genetics in Medicine

I just received the May issue of Genetics in Medicine, only 24 days late. But it caught my attention for several reasons.

The Sherpa Says: Doctors go to medical school for 4 years, then go onto residency for 4-8 years and some do fellowship for another 2-5 years. And then we give risk assessment and diagnose and treat. Why do people forget that? Oh and we first operate under the principle of First Do No Harm. What doesn't Mr Goetz get about that
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Poetic Justice for Andrew Wakefield

05/25/2010 02:32 PM |

http://health.usnews.com/health-news/blogs/on-parenting/2010/05/24/study-early-childhood-vaccines-dont-damage-kids-development

On Parenting

Study: Early Childhood Vaccines Don't Damage Kids' Development

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Many parents worry that the vaccines recommended for a baby in the first year of life are just too much too soon for an infant's immature immune system. Those fears have fueled a growing trend of parents delaying or refusing to vaccinate their babies. But a new study in Pediatrics examined the long-term effects of delaying vaccines and found that children whose parents refused or postponed vaccines did no better than children who were vaccinated on time, when tested on things like speech, language, achievement, fine motor skills, attention, and general intellectual function seven-to-10-years later.

The news comes the same day that Andrew Wakefield, a British doctor who did more than any one person to propagate the belief that vaccines cause autism, was barred from practicing medicine in Britain. Wakefield's 1998 study, published in The Lancet, fingered the measles, mumps, and rubella (MMR) vaccine, as a cause of autism, though he looked at just 12 children. In February, The Lancet retracted his study, and Britain's regulatory group said Wakefield had been "dishonest" and "misleading" in conducting the research, including failing to disclose that he was working with lawyers who sought to sue vaccine manufacturers. Wakefield has moved to the United States.

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Generic Preemption?

05/25/2010 08:23 AM |

WASHINGTON -(Dow Jones)- The U.S. Supreme Court on Monday asked the Obama administration for its views on whether generic drug companies can be sued over allegations that they inadequately labeled their products.

Generic drug makers are seeking to preempt a product liability lawsuit by a woman who allegedly developed a severe neurological movement disorder after taking generic versions of the heartburn drug Reglan.

The woman alleged the drug posed more serious risks than drug makers indicated on their labels.

A trial judge had dismissed the woman's lawsuit but an appeals court reinstated it last year.

The generic drug companies, including Teva Pharmaceutical Industries Ltd. ( TEVA) and Mylan Inc.'s (MYL) UDL Laboratories, said the lawsuit should be preempted by federal law because it would require them to write labels that deviate from the brand-name drug's label.

In ruling against the generic drug makers, the St. Louis-based 8th U.S. Circuit Court of Appeals cited a 2009 Supreme Court decision against Pfizer Inc.'s (PFE) Wyeth unit that said Food and Drug Administration drug regulations do no protect a drug company from being sued under state law over drug labeling.

The 8th Circuit said Congress could have crafted a provision that preempted drug-labeling lawsuits against generic drug companies but chose not to do so.

In a short written order, the Supreme Court asked the U.S. Solicitor General's office to express the Obama administration's views on whether the court should consider the drug makers' appeal.

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The New 10 Commandments

05/25/2010 08:14 AM |

Take two tablets and call me in the morning.

The AMA has released its “Health Insurer Code of Conduct Principles.”  There are 10 of them, but let’s focus on #5:  “Medical Necessity.”  Here’s what the AMA has to say:

Medical care is “necessary” when a prudent physician would provide it to a patient for the purpose of preventing, diagnosing or treating an illness, injury, disease or its symptoms in a manner that is:  (a) in accordance with generally accepted standards of medical practice; (b) clinically appropriate in terms of type, frequency, extent, site and duration; and (c) not primarily for the economic benefit of the health plans and purchasers or the convenience of the patient, treating physician, or other health care provider.

And further down:

Health insurers must not use financial incentives that discourage the rendering, recommending, prescribing of, or referral for medically necessary care.

And finally:

No care may be denied on the grounds that it is not “medically necessary” except by a physician qualified by education, training and expertise to evaluate the specific clinical issues.

“Health insurers should provide access to necessary health care, protect the patient-physician relationship and accurately process medical claims, but too often they are an obstacle,” said AMA President J. James Rohack, M.D. “The new Health Insurer Code of Conduct Principles will help protect patients and physicians from questionable insurance practices by holding the health insurance industry accountable.”

The AMA’s full statement along with a link to their new 10 Commandments can be found here.

And, let’s not forget who the nation’s biggest health insurer is – that’s right, Uncle Sam.

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