Pound Foolish

07/28/2008 12:21 PM |

Experimental cures are often the last hope for dying patients in the U. K. health system. Thanks to the British government, however, many sick Britons will soon have their last hopes dashed.

Why? Pharmaceutical companies from around the world have been scaling back clinical research in the United Kingdom, largely because of government parsimony. And British citizens have paid the price.

Read more about this distressing development here:

British system discourages availability of new drugs

With health care reform in America at the top of the agenda this election season, it’s more important than ever that we be aware of the dangers of government- run health care. America should avoid Britain’s mistakes and make sure we keep the interests — and hopes — of patients first in our pursuit of reform.

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Some People Just Want to Watch the World Burn

07/27/2008 05:29 PM |

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NPR Does PR for NICE and NHS

07/25/2008 06:17 PM |

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One of the other Johns from Arizona

07/25/2008 11:28 AM |

Often considered a surrogate for Senator McCain on all matters healthcare, we interviewed Representative John Shadegg (R, AZ) to see what he had to say.

See for yourself:

Shaedegg Video Interview

And let us know what you think.  Read More & Comment...

Off his meds

07/24/2008 06:44 PM |

Per the Zyprexa show-trial, consider the remarks of US District Court Judge Jack Weinstein:

“Compared to its peer agencies in other parts of the world, the FDA has arguably failed consumers and physicians by over relying on pharmaceutical companies to provide supporting research for new drug applications; by allowing them, through lax enforcement, to conduct off-label marketing; by acquiescing to industry pressure on drug labels; by not requiring doctors-the main line of defense against misusing prescriptions-to be adequately informed; and by leaving information dispersal and control largely to industry-influenced medical journals and non-governmental associations. The result of such claimed governmental failures arguably causes overuse and overpricing of pharmaceuticals, resulting in mass litigations such as this one for Zyprexa.”

How do you spell “r-e-c-u-s-a-l?”

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NICE Seeks to Sell Rationing Services

07/24/2008 12:52 PM |

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Able Victor

07/24/2008 10:01 AM |

As we mourn the passing of Victor McKusick, “the father of medical genetics,” his legacy lives on in today’s healthcare headlines.

Today, as if in honor of the great man's passing, the FDA will announce an advisory for physicians to use a genetic test to screen patients before prescribing abacavir, a widely used drug for H.I.V. infection and AIDS.

(Abacavir, developed by GlaxoSmithKline, is sold under the name Ziagen. It is also a component of two combination pills — Trizivir and Epzicom.)

According to Andrew Pollack in today’s New York Times, “The recommendation for the test is part of a movement toward so-called personalized medicine, in which genetic or other tests are used to determine which drugs are best for a patient and which should be avoided.”

Here is the complete New York Times story

Let’s honor Dr. McKusick by fully funding the Reagan/Udall Foundation and advancing the agenda of the FDA’s Critical Path Initiative.   Read More & Comment...

You say tomato, I say drug importation

07/23/2008 02:44 PM |

Since June, at least 1,200 Americans have been diagnosed with salmonella poisoning.

Early on, the Food and Drug Administration believed that the culprit was tainted tomatoes. It spent weeks trying to locate the source and failed to turn up any definitive evidence. Officials announced last week that tomatoes are safe to eat.

The agency now suspects that another kind of produce — perhaps Mexican-grown jalapeño peppers handled by a small Texas produce shipper — may have caused the outbreak.

But things could be worse. Imagine if the contaminated goods weren’t produce but instead prescription drugs, coming in from all over the world.

Sound far-fetched? It’s more likely than you might think.

Here’s the rest of the story in today’s edition of the Ft. Worth Star-Telegram:

Ft. Worth Star-Telegram Op-Ed

As the FDA struggles to find the source of contaminated produce, Congress should take time to reconsider the problems with legalizing prescription drug importation.

If it doesn’t, the results could be much worse than food poisoning.  Read More & Comment...

Rhetoric is Easy. Healthcare Reform is Hard.

07/23/2008 02:29 PM |

If there’s, as some claim, a “media love fest" going on with Senator Obama, then the Man from Illinois’ healthcare rhetoric isn’t part of it.

Consider today’s story in The New York Times, “Health Plan from Obama Spurs Debate.”

Except that after you read the article, you realize that the headline should have more appropriately been, “Health Plan from Obama Spurs Derision.”

According to the Times:

“While there is consensus that the American health care system is bloated with waste, eliminating enough to save $2,500 per family would require simultaneous and synergistic solutions to a host of problems that have proved intractable for decades.”

And:

“Mr. Obama … is offering a precise “chicken in every pot” guarantee based on numbers that are largely unknowable. Furthermore, it is not completely clear what he is promising.”

And:

“But the health policy advisers who formulated the figure say it actually represents the average family’s share of savings not only in premiums paid by individuals, but also in premiums paid by employers and in tax-supported health programs like Medicare and Medicaid.

And, according to Harvard’s David Cutler (an unpaid advisor to the Obama campaign and a certified smart guy), “Our attempt to lay out one plausible scenario for the savings had created more problems than it had solved.”

And:

“But whether employers and governments respond that way cannot be guaranteed, particularly in a difficult economy. And a number of health policy experts have questioned whether the $2,500 projection is either fiscally or politically realistic. Reducing health care costs, they emphasized, means taking money from someone’s pocket and rationing care that Americans have come to expect, a recipe for stiff resistance.”

Here is a link to the complete NY Times story:

New York Times story

Well gosh, you mean that healthcare reform is going to be hard? Stop the presses. (Or, perhaps, start them.)

Another regularly bandied about “solution” is for the United States to adopt “free” healthcare, “like in Europe.”

Let’s address that shibboleth.

People in other healthcare systems often pay more than Americans do, sometimes in the form of taxes. And they may also incur high costs if they need a drug that is not covered by their health system or want to see a specialist.

In the US, a family of four with an employer-based PPO will have around $15,609 total this year in healthcare costs. Of this amount, the employer will pay $9,442 and the employee will contribute $3,492 in premiums and $2,675 on co-pays, etc. That’s about 6 percent of average family income.

In Canada, while the percentage of taxes used to provide healthcare varies, it is estimated that 22 percent of taxes collected went to the health system in 2004. Several provinces, including Quebec, Ontario, Alberta, and British Columbia, also charge additional premiums. Canadians also may spend money to receive private treatment for procedures or drugs that are not covered by the government system.

Citizens of the UK pay 11 percent of each pound they make in weekly income between £100 - £670 for the NHS, plus an addition 1 percent of income over £670 a week. Though the co-pay for drugs is low, many drugs are not covered, often because they not considered cost efficient. And anyone who uses their own money to buy powerful but expensive drugs not paid for by the NHS finds him or herself shut out of the NHS for having gone outside the system.

In Germany, coverage from a public sickness fund currently can range significantly in cost, from around 12.2 to 16.7 percent of income, with the employee paying a bit under half. As of fall 2008, premiums are to be standardized from the federal level and healthcare experts anticipate that they will be set around 15.5 percent. Private patients can generally expect to pay more than they would in the public system.

In France, employees contribute only to 0.75 percent of their salaries towards medical care, but also pay a 7.5 percent General Social Contribution, the majority of which is earmarked for the health system. This base coverage reimburses people for the majority of costs for doctor visits and for a portion of the costs of medications. On top of the government coverage, almost all French residents have supplementary coverage from a mutuelle, costing approximately 2.5 percent of salary.

For a more complete look at “myths vs. facts” of “free” European-style health care, have a look at this new article in the Journal of Life Sciences:

Journal of Life Sciences article


And if you’re ready for a barrage of reality about how patients fare under various European systems (Canada too), click here:

www.biggovhealth.org

And let the debate over real reform begin.  Read More & Comment...

Jim Jam

07/22/2008 06:55 PM |

I just came across a new web site, www.thoreau-fda.com/index.php.

It defines itself as “a website launched and operated by current and former US Food and Drug Administration staff who believe public health is being put at unnecessary risk. These concerned civil servants and ex-civil servants have either experienced or are aware of wrongful directives by US FDA upper management – directives that put public health at avoidable risk.”

That’s nice.  But when you check out to whom the site is registered, it turns out to be Jim Dickinson of FDAWeb.com – no fan of the FDA and no former FDA employee.

Oh well, so much for transparency.

Perhaps Jim should heed the words of Mr. Thoreau, to wit:

“If you would convince a man that he does wrong, do right.”

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How Novel Managed Care Managing Care

07/22/2008 05:59 PM |

Nearly 40 years to the date they were conceived, managed care plans come together to come to the realization that to stay in business they should focus on patients not on cutting costs...

amednews.com

Insurers are the new worried well (America's Health Insurance Plans annual meeting)
In the wake of declining profits, health plan executives discuss what they need to do to remain viable. Their solution: focus on changing patient behavior.

By Emily Berry, AMNews staff. July 28, 2008.

Reports from conferences important to physicians

Paul Wallace, MD, a Kaiser Permanente medical director, stood before other health plan leaders during a packed session at the annual meeting of America's Health Insurance Plans in San Francisco in June and told them their job is no longer to pay bills, but to manage members' health.

Paul Wallace, MD, a Kaiser Permanente medical director, stood before other health plan leaders during a packed session at the annual meeting of America's Health Insurance Plans in San Francisco in June and told them their job is no longer to pay bills, but to manage members' health.

They got the message. As Dr. Wallace concluded, he asked the audience: "Is anyone here not in the behavior-change business?"

No hands went up.

The admonition that health plans are meant to manage care might not sound new, given that back in the early 1970s HMOs were created to do just that. But health plans are now talking about managing care not only as essential for their members' health, but essential to their own.

That message echoed throughout the AHIP Institute, the name for the annual meeting of the trade group representing health plans.
http://www.ama-assn.org/amednews/2008/07/28/bisa0728.htm


But let's not get too enthusiastic....just a couple of months ago the HMOs said they would dump patients to protect profit margins...
BUSINESS
Health plans say they'll risk losing members to protect profit margins
Meanwhile, businesses and individuals are dropping coverage in the wake of higher insurance premiums.

By Emily Berry, AMNews staff. May 19, 2008.

The nation's largest publicly traded health plans say they don't plan to temper premium increases for the sake of keeping members on their rolls -- particularly not while they are under pressure from Wall Street over what it sees as their disappointing earnings.
Article here


And let's not forget how AHIP and CBO are working together to "bend the curve" on health care by setting up a comparative effectiveness institute run by government bureaucrats....  Read More & Comment...

NICE stiffs RA patients

07/22/2008 02:38 PM |

Still think that “government” care = “universal” care? Think again.

According to a report in The Guardian:

Potentially life-changing drugs for rheumatoid arthritis could be rationed for the UK's 60,000 sufferers, patients' groups warned today. Potentially life-changing drugs for rheumatoid arthritis could be rationed for the UK's 60,000 sufferers, patients' groups warned today.

NHS patients should not be allowed to try a second inhibitor if their first attempt fails, the National Institute for Health and Clinical Excellence (Nice) has decided.

Charities said that could leave sufferers with pain and the possibility of long-term disability.

Trying different anti-TNF therapies (tumour necrosis factor alpha inhibitors) is common. The British Society for Rheumatology Biologics Register showed around 70% of patients will get a good response from a second anti-TNF if the effects of the first start to wane.

Now charities and patients' groups are preparing to appeal against NICE's ruling before final guidance is issued to the NHS in September.

Rob Moots, clinician for the Arthritis and Musculoskeletal Alliance, and professor of rheumatology at Liverpool University, said the ruling flew in the face of clinical judgment.

"It's almost impossible to know which anti-TNF will work for a patient at the outset," he said.

"Before this decision we could try patients on each of the three treatments in turn to find one that was effective for them - now we only have one shot at success.

"Many patients will be left in astonishing pain, while knowing we haven't explored all the options for them."

Rheumatoid arthritis is an auto-immune disease for which there is no cure. It occurs when the immune system attacks the joints, causing swelling and damaging cartilage and bone.

Ailsa Bosworth, the chief executive of the National Rheumatoid Arthritis Society, said today's move, combined with a NICE decision in April to reject the drug abatacept, meant effective therapies had been cut from five to two.

For more reasons to be afraid, very afraid, of government healthcare, visit www.biggovhealth.org.

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Doctor -- reveal thyself

07/22/2008 12:43 PM |

Yesterday I attended a seminar (sponsored by Pfizer) at the New York Academy of Sciences. (40th floor at 250 Greenwich Street -- what a view!)

But the views offered on the inside were equally stimulating.

A few examples:

Elizabeth Teisberg (Professor, Darden School of Business, University of Virginia):

"Today pay-for-performance" means "pay-for-process-compliance."

Dr. J. Edward Hill (Past President, American Medical Association):

"If we believe in evidence-based medicine, then we should consider the evidence of what government run healthcare provides."

Dr. Hill also posed this interesting question, "Can we really have personalized care provided by the government?"

Dr. Michael McGinnis (Senior Scholar, Institute of Medicine):

"40% of deaths in the US are caused by the behavioral choices we make," led by lack of diet, not enough exercise -- and tobacco.

He also pointed out that "what happens at the intersections of the domains of influence" is what drives both health and care. McGinnis defined the relevant "domains of influence" as Behavioral, Genetic, Social, Environmental, and Healthcare.

There was much heated debate and audience participation -- but the most memorable comment was also one of the pithiest and it came from Dr. Hill who said, "People need to quit being complacent."

And included on that list of people needs to be doctors.

(Yes, doctors are people too.)

I asked Dr. Hill why we only hear from doctors when it's about their payment schedules. His reply was honest -- "I was afraid someone was going to ask me that question."

And that's when he offered the remark about complacency.  Read More & Comment...

Deutschland's Doctors Outta Options

07/22/2008 05:48 AM |

From a 2006 Spiegel International article....

GERMAN BRAIN DRAIN

Sick of Bad Pay, Doctors Flee Germany

By Udo Ludwig

German doctors are packing their scalpels and seeking their fortunes abroad, lured by the prospect of far higher pay and driven away by stifling bureaucracy in their country's health service.http://www.spiegel.de/international/0,1518,399537,00.html

Where are they going? Take one guess...

"The NHS is flying in doctors from Germany to provide out of hours cover for GPs, at a cost of up to £650 a day.

The news comes a week after it was revealed that a health board hired a doctor from Italy to cover a remote practice over Christmas.

Such doctors are being used to work shifts, including holidays and weekends, that British GPs no longer have to cover following contracts introduced in 2005.

A Scottish health board is using GPs from Germany to provide out of hours care, sourced through a foreign recruitment agency.

NHS Grampian has used at least two doctors from Germany through the agency, which charges between £60 and £65 an hour for shifts that can last for up to 10 hours. Over Christmas, another Scottish health board, NHS Highland, flew Dr Annibale Bertollo from Venice to provide cover for a practice in Wester Ross for five days."

Read Article

Here's wondering if Obama will praise the German health care system as a model for reforming our own....

  Read More & Comment...

Fellowship-shape

07/21/2008 12:21 PM |

The FDA said Thursday it will launch a two-year fellowship program for physicians, chemists, statisticians and other science professionals interested in food and drug regulation. About 30 to 40 fellows will be accepted for the first program, which begins in October. Some of those accepted are expected to stay on as full-time employees after completing the program, which includes course work and seminars.

This is crucial since the average age of the FDA's work force is 54, and about 30 percent of general staffers already are eligible to retire.

That’s why “a strong FDA” is part of the agency’s five year strategic plan.

FDA’s most proprietary and valuable resource comes through the door each morning. There are almost 1,500 people with PhDs at FDA and well over 400 with medical degrees – and that’s without double counting.

An organization that can keep up with the rapid changes in the industries that it regulates, and that is capable of developing and implementing effective and innovative public health measures, requires a very special workforce. The FDA’s mission depends more than ever on a solid cadre of experienced physicians, toxicologists, chemists, statisticians, mathematicians and other highly qualified and dedicated professionals. Their expertise is essential for making regulatory decisions that are balanced and fair and timely -- and for keeping the agency on the cutting edge of the technology and sciences used by industry.

Agency leadership must make it a priority to encourage creativity, efficiency, and superior performance - an environment that attracts and retains top-quality scientists, and enables them to do top-quality work as part of an effective team.

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Insta-Think in Medical Research

07/20/2008 09:52 PM |

Another trend with disturbing implications for the quality and conduct of medicine: online publication of research is creating memes that rapidly lead to consensus absent any validation with older research. ( "Richard Dawkins, in his book The Selfish Gene, recounts how and why he coined the term meme to describe how one might extend Darwinian principles to explain the spread of ideas and cultural phenomena. He gave as examples tunes, catch-phrases, beliefs, clothing-fashions, and the technology of building arches" . en.wikipedia.org/wiki/Meme. )

"Over the last decade or so, access to scientific literature has changed radically. Reading a research paper no longer requires a trip to the library, as the research journals are only a web browser away. A paper in the current edition of Science looks into whether this transformation has triggered a corresponding change in how that literature is used. Its author's statistical analysis suggests that the ready availability of scientific information has a counterintuitive result: a smaller pool of articles are referenced in the scientific literature."

Using Thompson's citation index (CI), which indexes articles and references from the 6000 most highly cited journals, and Information Today's Fulltext Sources Online (FSO), sociologist James Evans has examined what effect the availability of online articles has had on how researchers cite previous work. The combined data from CI and FSO hold over 26 million articles and an additional 8 million distinct articles that referenced them through 2006.

His conclusion?

"Fewer and fewer distinct articles were cited even as more publications could be accessed online... "

"The conclusion of all this statistical work was that, as more and more articles are readily available online, researchers, on average, cite fewer articles. The articles that are cited are newer, and fewer distinct articles receive attention. The results of the explosion of easily available articles, according to Evans, is that "researchers can more easily find prevailing opinion, they are more likely to follow it, leading to more citations referencing fewer articles." As a side effect of this, a scientific consensus will typically form more rapidly. The other side of this is that papers containing ideas that don't catch quickly will be forgotten by the scientific world much faster. "

Which stifles debate, discussion, error correction. Someone who is not careful or wishes to unduly influence medical opinion would merely have to publish a handful of articles -- bereft of previous research so as to reduce the chances for comparison -- in a handful of journals to change thinking and consolidate consensus quickly all the while evading serious scientific scrutiny. And once a rash conclusion reaches the public it is quickly disseminated -- online again-- where it whirls into common use. Meanwhile minority opinions -- even those with more solid scientific support -- can be ignored or attacked.

Sound familar? How about the vaccine-autism controversy or the Avandia or SSRI scare? I would like to see what percentage of articles are now actually original research as opposed to meta-analysis or combing through of databases which is easier and quicker to publish and which "leading publications" are more eager to run with to generate attention.

The internet can rapidly distribute new information. But not all information is new knowledge, which is information that advances understanding.

Insta-think can lead and does lead to Tabloid Medicine.

Science, 2008. DOI: 10.1126/science.1150473

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Mr. Stupak, apologize now!

07/18/2008 01:25 PM |

Reps. John Dingell and Bart Stupak on Thursday questioned whether FDA officials knew about the potentially fraudulent information but approved Ranbaxy's products anyway.

Stupak said the Ranbaxy case "may be another example in which FDA found it inconvenient to assure the safety and effectiveness of drugs before approving them."

The Rambaxy situation is very unsettling and certainly worthy of investigation. Casting such snide unfair aspersions on the hard working career staff of the FDA is not.

Mr. Stupak -- apologize now!

 

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Rancid Ranbaxy Investigation on the Hill

07/18/2008 12:40 PM |

Want a preview of how the idiots in Congress will deal with a tidal wave of tainted medicine if drug importation becomes reality?

Take a look at the response to the allegations that Ranbaxy was hiding data from the FDA about the safety and integrity of their products. Large company is accused of willingly conspiring to evade and avoid FDA scrutiny even as it submits the "right" data and who is hauled before Congress?

FDA, the same FDA that has been lambasted for being short of staff. It is now being all but accused of conspiring with Ranbaxy.
If importation becomes a free trade zone for counterfeiters, you will see more evasion as the opportunities for profit and piracy pile up.

Don't expect Congress to take the blame for poisoning our medicine supply.

Read more here
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All Paul is divided into three parts

07/18/2008 12:38 PM |

Here's our interview with Congressman Ron Paul:

Ron Paul videocast

Not surprisingly, he has a lot to say -- but we tried to keep him focused on healthcare.

And we were almost successful. You be the judge.



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Pen ultimate reflections

07/18/2008 11:42 AM |

It’s surprising how much ink is being spilled over the revised PhRMA code – considering it bans free pens.

Less surprising are the indignant musings of those whose only metric of the code’s “success” is a decrease in marketing efforts. Consider the opinion of Robert Restuccia, Executive Director of the unbiased and entirely unconflicted Prescription Project.

If spending is up, he figures, then voluntary compliance is a failure.

That’s pretzel logic.

The whole issue of whether drug marketing spending goes up or down is a non-sequitor when it comes to PhRMA marketing code compliance. Linking spending to compliance is like linking sunshine to gas prices. No relation at all.

What it does demonstrate is the frustration of Mr. Restuccia and his fellow travelers, who believe that drugs shouldn’t be marketed at all. Those who preach the inadequacy of voluntary marketing codes believe that “compliance” should result in, de minimus, reduced marketing and, ultimately, no marketing at all.

And if you don’t think this is their pen-ultimate goal, it’s time to wake up to reality.

Note to Prescription Project: “Good for sales” and “Good for the public health” need not be mutually exclusive.

Regulation (via voluntary codes or government legislation) doesn’t mean what is being regulated is bad. It means that it needs to be done in a certain way.

And that benefits everyone.

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