mcclellan for HHS?

02/03/2009 07:00 PM |

Good for the administration and health care....
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Daschle Packs It In

02/03/2009 06:41 PM |

How fast did President Obama go from being strongly behind Daschle to telling him to head back to South Dakota?  One thing is now certain: the inevitability of health care reform Obama or Baucus style is no longer.... Is there is an opening here for patient-centered provision of coverage? 
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Comparative Effectiveness Slush Fund

02/03/2009 03:12 PM |

The focus on Senator Daschle's failure to pay taxes in a timely fashion should shift to examining who controls and gets the $1.1 billion in comparative effectiveness money that goes to Agency for Healthcare Research and Quality.  That cash will be doled out  in large part on the sole discretion of Daschle  himself who wants NICE-like comparative effectiveness rulings to determine tax benefits for insurance deductibilty.  The rest is under the control of Carolyn Clancy and a handful of "stakeholders" largely beholden to to HMOs and ties to think tanks with funding from trial attorneys and foundations that support attacks on medical innovation and want a government take over of healthcare.  In addition, the institutes carrying out the work are creatures of the HMOs themselves or contractors thereof. 

No media scrutiny whatsoever and yet more than $1 billion of tax dollars to be spent in the stimulus....

Way to go.  The media is complicit in the creation of a slush fund for Daschle that pales in comparison to whatever tax filing mistake he may have made. 
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Those Pesky Facts about Healthcare Reform

02/03/2009 12:36 PM |

"I believe for the first time in American history, health care reform will be done."

That's the incoming Secretary for Health and Human Services, Tom Daschle, speaking at a national conference on health care reform in December.

Daschle is right to be optimistic. Too many Americans lack health insurance, and there are many opportunities for reform.

Unfortunately, his reform ideas center on the government's playing a larger role in the health care market. This concept is popular among voters, as there's a widespread perception that health care systems abroad are a runaway success. The media tends to present those systems in the best light possible, highlighting their apparent benefits and ignoring their downsides. As a result, many Americans have overly positive visions of what life is like under universal health care -- and so support its creation here at home.

The truth is that government-controlled health care is not free. It comes at a great cost in the form of high taxes, long waiting lines and frequent denials of coverage.

French citizens pay about 20 percent more in income tax than Americans, according to the Organization for Economic Cooperation and Development.

The Fraser Institute reports that Canadians face an average wait of almost 18 weeks between a general practitioner's referral and actual treatment by a specialist.

In the United Kingdom, the national health care agency won't cover treatments with a yearly cost of more than $46,000. British citizens pay 11 percent to 12 percent of their weekly income to finance the country's health care system. Many popular pharmaceutical drugs aren't covered by public insurance.

It's estimated that about one- fifth of taxes collected in Canada go toward funding the country's health system.

So much for "free" health care.

Most universal health care systems also impose strict price controls on pharmaceutical drugs. But, as a new study from the Rand Corp. finds, introducing similar price regulations in the U.S. would stifle drug innovation, resulting in reduced average life expectancy.

The costs of universal health care are real and substantial. It's imperative that voters and legislators see the other side of the story before any reforms are implemented.

For the rest of the story, have a look at this op-ed from the Chicago Sun-Times.

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Something rotten in Denmark?

02/03/2009 10:11 AM |

When I was working on the issue of DTC and patient information a couple of years back (my report may be downloaded here) , I sometimes wondered why a European firm didn’t simply take out an ad to say : "We have many drugs that could help you, but we are not allowed to tell you about them."

The other day, some oncologists in Denmark did a similar thing. According to some new authority, there is no evidence that the benefit from the cancer medicine Avastin outweighs the negative impact of side-effects. This would justify the decision not to make this product the first choice when treating lung cancer.

The oncologists begged to differ, and circulated a letter to the concerned patients to inform them of their view.

According to the Swedish website Dagens Medicin, the central authority Danske Regioner will now stop this letter from being sent.

Said the politician in charge : "It would be very unethical to distribute such letters now that we have done so much to build confidence in Danish cancer treatments."

Really ? Is it more "ethical" to silence doctors who actually believe in the benefits of a certain treatment ? Probably not; but this is about saving money, sorry, rational use of drugs.



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Decommissioning Darvon

02/02/2009 02:47 PM |

Here's the black box warning that has been attached to Darvon and it's generic version's for years:

"Darvon should not be used by people who are suicidal or who easily become addicted to medicines, alcohol, or other substances. Do not take more of Darvon than the dose your doctor prescribed. Taking excessive doses of Darvon by itself, with other medicines, or with alcohol may cause serious side effects and could be fatal. Limit the amount of alcohol you drink while you are taking Darvon . Tell your doctor if you have a history of any substance abuse, mood or mental disorders, suicidal thoughts or attempts, or if you take any medicines that cause drowsiness such as tranquilizers, sleep medicines, muscle relaxers, or antidepressants."

And here is an Time Magazine article about Darvon and the efforts of Sid Wolfe, now an offical pain the you know what as a member of the Risk Benefit advisory committee for the FDA, to ban the drug:

"... Wolfe asked for an immediate ban on the sale of the widely prescribed pain reliever propoxyphene, best known as Darvon. He claimed not only that Darvon is an ineffective painkiller, but also that in excessive doses it produces a euphoric high, which he says, "makes it attractive as a drug of abuse. This is tantamount to legalized dope." Further, said Wolfe, Darvon-related deaths in the U.S. have been increasing, rising in major cities to about 600 last year and making the compound "the deadliest prescription drug in the United States." Eli Lilly and Co., of Indianapolis, the principal manufacturer, promptly branded Wolfe's charges "irresponsible and clearly not supported by the facts."

Darvon-related deaths have often involved intentional misuse, either by overdosing or mixing with alcohol and other drugs. Lilly notes that the average person would have to take 30 large-size Darvon capsules at one time (the usual dose is one every four hours) to cause death, 15 if he were intoxicated. Further, the drug is a controlled substance—a prescription is good for only five refills within six months. (If HEW will not ban Darvon, Wolfe wants the drug reclassified so that prescriptions cannot be refilled.)

Lilly also says that Wolfe's claim about Darvon's effectiveness is misleading because it is largely based on studies of single, rather than multiple, doses of the drug. Doctors prefer Darvon for some patients because, unlike aspirin, it does not cause gastrointestinal bleeding or lower the body temperature. Concludes Lilly's Dr. Robert Furman: "Used as directed, Darvon is really very safe. The fact that some people are intent on abusing it shouldn't be used to indict it."

Read More

That article was written 40 years ago. Wolfe was petitioning the FDA then.

I can't say I totally disagree with Wolfe's motives. Darvon and Darvocet were and are the drug of choice for people who seek to commit "peaceful suicide' and is pushed as such by pro-suicide groups and chat rooms. The problem is, banning the drug will remove another effect medicine for menstrual cramps that does not cause internal bleeding and if the UK is any guide those seeking to commit suicide or use painkillers recreationally will use medicines that are stronger or have worse side effects than liver toxicity.

Wolfe's persistence is an example of ideology overriding science and the doctor-patient relationship. The Sid Wolfe fan club (Alicia Mundy, President) might delight in his longstanding effort to drive drugs he detests off the market but for many people, including me and family members, his personal choices would come at the expense of our very lives.

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Sooner is Better

02/02/2009 12:31 PM |

"The president hopes in the next few days to announce a pick for commissioner at FDA," White House spokesman Robert Gibbs told a press briefing.  Read More & Comment...

Non-Interference: Daschle was for it before he was ...

02/02/2009 12:23 PM |

The attempts to revoke the Non-Interference Clause have begun. Representatives Marion Berry (D-Ark.) and Jan Schakowsky (D-Ill.) have introduced The Medicare Prescription Drug Savings and Choice Act (HR. 684), with companion legislation in the Senate soon to come from Senator Richard Durbin (D-Ill.) as S. 330.

The same members introduced similar bills in 2005 and 2007. Bad idea then.  Bad idea today.  At least they didn’t try to bury it in the stimulus package.

In addition to gutting the Non-Interference Clause (originally authored, it should be remembered – by Senators Kennedy and … Daschle) HR. 684 would create a federal drug plan option to compete with privately offered Part D plans.

"We have many reasons to be optimistic about the passage of this legislation," Schakowsky said. "It is very much in line with [President Barack Obama's] overall plan in that it gives people an option of a public plan or sticking with a private plan."

When combined with the "Federal Coordinating Council for Comparative Effectiveness Research" (a $1.1 billion earmark in the stimulus package that won’t create a single job on “Main Street”), there's the real potential for Uncle Sam to dictate that Part D prices be tied to prices in other countries -- a kind of Medicare reference price and a big step towards overall price controls.

And price controls = choice controls.

This new “Federal Council” (under the Agency for Healthcare Research and Quality and with zero patient group, industry or academic representation – it’s 100% government) would be responsible for "assessing the clinical benefit of covered Part D drugs and making recommendations to the secretary on which drugs should be included in the formulary."

In addition, an advisory committee can request AHRQ conduct clinical effectiveness and comparative effectiveness studies on drugs.

That means bureaucrats in Washington will be able to tell doctors how to practice medicine by dictating formulary options.

Wither competition? The Bill sponsors expect that if the bill becomes law, it would ultimately limit the number of plans participating in Part D, as private plans would drop out from competing with a publicly run plan.

And to that point, a few things worthy of consideration:

"It is not obvious that allowing the government to negotiate with pharmaceutical companies will lead to lower prices than those achieved by private drug plans. Private plans like Kaiser or United are able to negotiate deep discounts with pharmaceutical companies precisely because of the plans' ability to say no – the ability to include some drugs and to exclude others, allowing the market to judge the resulting formulary. On the other hand, when the government negotiates, its hands are tied because there are few drugs it can exclude without facing political backlash from doctors and the Medicare population, a very influential group of voters. Neither economic theory nor historical experience suggests government price negotiation will achieve lower drug prices. Congressional Democrats need to be careful in making the logical leap from market share to bargaining power. Empowering the government to negotiate with pharmaceutical companies is not necessarily equivalent to achieving lower drug prices. In fact, neither economic theory nor historical experience suggests that will be the outcome. Members should think carefully before jumping on the bandwagon – this promise may bring just the opposite of what was ordered."

Stanford Business School's Alain Enthoven and Kyna Fong

"Both the non-partisan Congressional Budget Office and Medicare actuaries have said they doubt the government could negotiate lower costs than the private sector. The theory behind Part D is that market forces and competition among drug plans, overseen by government, can achieve better results than a government-run program. The multitude of plans allows seniors to pick one that best meets their needs. Government price negotiation could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. Medicare recipients account for half of all drug prescriptions. With that kind of clout, government might try to dictate prices, not just negotiate them. This could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. The VA plan illustrates the point. It offers 1,300 drugs, compared with 4,300 available under Part D, prompting more than one-third of retired veterans to enroll in Medicare drug plans."

"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06

The bottom line here is that Part D is a tremendous success – due in no small part to the Non-Interference Clause.  Consider:

* The projected cost for Medicare Part D is $117 billion lower over the next decade than experts estimated just last summer. This means that over the 10-year period from 2008 to 2017, the estimated $915 billion cost of Part D fell to $798 billion.

Why?  Marketplace competition.

* And, according to a study published in the Annals of Internal Medicine, the Medicare drug benefit led to a 17 percent decrease in out-of-pocket expenses, or $9 a month, for seniors who enrolled in the new Medicare Part D benefit in 2006, the first full year prescription coverage became available in the federal health insurance program for the elderly and disabled.

* And the savings amounted to an extra 14 days of medicine for those who signed up, or a 19 percent increase in prescription usage.

Can Part D be made even better? Absolutely. But this is good news worth sharing -- and not because it helps any particular partisan political agenda but because it means that more Americans -- tens of millions of more Americans -- are getting access to the medicines (largely chronic medicines) that will help them live healthier lives. And this, in no small measure, significantly reduces more drastic medical interventions -- which in turn reduces our overall national health care spending.

We shouldn’t interfere with success.

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The Pluck Starts Here

01/30/2009 06:04 PM |

According to Senator Ben Nelson (D-NE), it's unclear whether President Obama's $819 billion economic stimulus bill will win enough support to pass in the Senate. "I don't even know how many Democrats will vote for it, as it stands today," he told FOX News.

Seems like the upper house is unhappy that the bill, passed by the other house on Wednesday, contains billions of dollars for programs that arguably won't spark much job growth. Senator Nelson wants to pluck out what he says are extraneous projects in the stimulus bill to pay for the amendment.

How about plucking out the “sneaking socialism of healthcare.” Specifically  the $1.1 billion for a "Federal Coordinating Council for Comparative Effectiveness Research."  Not only is this expense a slippery slope towards a NICE-like body for the U.S. – it wouldn’t create a single job for "Main Street."

Here’s a suggestion – give that money to the FDA to hire more scientists, reviewers, and inspectors, update their woeful IT infrastructure, and fund the agency’s Critical Path program.

That’s what I’d call a real stimulus package!

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Economic Stimulus Package to Promote CER … Or Mandate it?

01/30/2009 04:07 PM |

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Peanuts for Counterfeit Actions

01/30/2009 03:33 PM |

Well that’s what “consensus” gets you.

The World Health Organization has caved in to pressure by the developing countries (specifically India and Brazil), and dropped their resolution on counterfeit drugs. This non-decision is being portrayed as a victory for the developing world’s generic drug industry -- which has long opposed the WHO attempt.  Their objection is that, under the proposed new definition, their products could be defined as counterfeits.

The current definition of WHO says counterfeit drugs are 'medicines which are deliberately and fraudulently mislabeled with respect to identity or source.

The proposed definition proposed removes the clause “deliberately and fraudulently” and replaces it with “a medical product is counterfeit when there is a false representation in relation to its identity, history, or source.”  It also says that ‘this applies to the product, its container, packaging or other labeling information.”

What are really at play here are the issues of semantics and transparency. What’s the difference between a product that is knowingly “substandard” versus one that is “counterfeit?”  If a company deliberately fails to comply with manufacturing quality standards – what do you call the product?

For starters, you call it dangerous.

Another issue recently brought to public attention via an Associated Press story (see link here) is the manufacture of medicines in India destined for First World markets that result in the poisoning of the local population because of a lack of environmentally safe manufacturing processes.

If it’s wrong for Americans to buy products produced by slave labor, isn’t it just as wrong to purchase medicines from companies who have total disregard for the health and well-being of local citizenry?

As America focuses on peanuts as a metaphor for regulatory reform, perhaps it’s time for the global community to tie counterfeiting to corporate responsibility.

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FDA Commish Rumor du Jour: Peggy Hamburg

01/30/2009 01:45 AM |

Whispers are that there is "a woman" in the mix and that it's Peggy Hamburg.

Here's her bio:

Margaret A. Hamburg, MD, Senior Scientist, Global Health and Security Initiative, NTI

One of the youngest people ever elected to the Institute of Medicine of the National Academy of Sciences, Dr. Margaret “Peggy” Hamburg is a highly regarded expert in community health and bio-defense, including preparedness for nuclear, biological, and chemical threats.  She currently serves as Senior Scientist for the Global Health and Security Initiative of the Nuclear Threat Initiative, a foundation dedicated to reducing the threat to public safety from nuclear, chemical, and biological weapons.  A graduate of Radcliffe College, she earned her M.D. from Harvard Medical School, and completed her training at the New York Hospital/Cornell University Medical Center.

From 1997 to 2001, Hamburg held the position of Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services (HHS), serving as principal policy advisor to Secretary of Health and Human Services Donna Shalala.  From 1991 to 1997, she served as New York City Health Commissioner, a position in which she designed and implemented an internationally recognized tuberculosis control program that produced dramatic declines in tuberculosis cases, and created the first public health bio-terrorism preparedness program in the nation.  Between 1986 and 1990, she held a variety of positions within HHS, including Special Assistant to the Director, Office of Disease Prevention and Health Promotion; and Special Assistant to the Director, and later Assistant Director, of the National Institute of Allergy & Infectious Diseases at the National Institutes of Health.

A member of the Harvard College Board of Overseers and the Boards of Trustees of Rockefeller University and the Rockefeller Foundation, Hamburg is also a distinguished senior fellow with the Center for Strategic and International Studies, and a fellow of the American Association of the Advancement of Science.  She holds membership in the New York Academy of Medicine, and the Council on Foreign Relations and serves on the board of Henry Schein Company.  She has served on the boards of other organizations, including the New York City Health and Hospitals Corporation, the Nathan Cummings Foundation, the Primary Care Development Corporation, and the Board of Scientific Counselors for the National Center for Infectious Diseases of the Centers for Disease Control and Prevention.

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Agent Orange (Book)

01/29/2009 02:31 PM |

According to a new Harris poll, 81% of Americans say they prefer generics to brand-name drugs.

That’s good news.  It means the message that FDA-approved generic drugs are safe and effective is finally getting some traction.  And the cost savings are significant.

But, as usual, there are those who would use this news for their own selfish purposes.  In this case it’s the Generic Pharmaceutical Association (GPhA).

Earlier this month, the GPhA applauded the introduction of HR 573, a bill that would prohibit the marketing of authorized generics during the 180-day generic exclusivity period. Kathleen Jaeger, chief executive of the GPhA, sees the proposed legislation as a way to close a “loophole” in the 1984 Hatch-Waxman Act that allows innovator life science companies “to delay generic competition by discouraging generic companies from challenging weak and potentially unenforceable patents." She praised the bill’s sponsor, Republican Jo Ann Emerson, and colleagues for “working to close this loophole for the benefit of consumers struggling with health care costs during these difficult economic times."

Well, if we’re all in this to help consumers control costs – then this bill would achieve precisely the opposite.

If the GPhA gets its way, the category of medicines known as “authorized generics” (also referred to as “branded generics”) will vanish — and drug prices for millions of Americans could go up by as much as 17%. (This calculation is based on a comparison of what consumers actually spent on generics during the 180-day exclusivity period to what they would have spent to purchase the same quantity of generics at higher prices in the absence of a branded generic launch.)
 
Historical pricing data shows that brand companies launch their generics at a 50 percent discount off retail price compared to a 30 percent discount experienced when a generic drug has no competition. If HR 573 passes, consumers and taxpayers over the next two years would realize about $8 billion instead of $13 billion in savings.  Cui bono? The missing $5 billion will line the pockets of a handful of generics companies.  That’s quite a cui bonus. This end-run around Hatch-Waxman is an extended index finger to the FDA, the FTC and judicial precedent. (A Federal Appeals Court made it clear that Hatch-Waxman allows for authorized generics.)

Over the next few years about $60 billion in brand drugs will become generic; $30 billion of that will be sold without competition for 180 days if Ms. Jaeger and Representative Emerson get their way.

No wonder this “modest proposal” is being greedily embraced by the generics industry and Big Pharma bashers. And greedy is hardly hyperbole since profits on generic medicines exceed 45% -- even when there is a competitive branded generic on the market.

We all call the existing legislation by its inside-the-Beltway designation, “Hatch-Waxman” – but let’s not forget that the full name of the law that brought the generic industry into being is the Drug Price Competition & Patent Term Restoration Act -- not the Generic Drug Company Guaranteed Profit Act. When the media and generic drug lobbyists conflate suspicious stalling tactics with legal and consumer-friendly market actions, neither the truth nor the public health are served.

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Ends, Means, Medical Devices and Felonies

01/28/2009 04:32 PM |

You mean the ends doesn’t justify the means?

According to an article in today’s edition of the New York Times, “Nine dissident scientists at the Food and Drug Administration who say they were forced to approve high-risk medical devices sent a letter to President Obama on Monday stating that agency officials might have made them the targets of a criminal investigation into their complaints.”

The complete New York Times story can be found here.  

If the FDA has undertaken such an investigation (and the agency will not confirm or deny), the reason is that these nefarious nine leaked confidential agency documents to the media.  That’s a felony.

The Nefarious Nine are unhappy that their complaints about device approvals aren’t being addressed with greater alacrity.  So, in their righteous indignation, they decided that their purity placed them above the law.

Unfortunately, not only will their behavior not speed up the agency’s investigation of their brief – it may very well slow it down.

Breaking the law is the wrong path to better regulatory oversight of medical devices. The ends doesn’t justify the means.  

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Kennedy on Cost Effectiveness

01/28/2009 11:32 AM |

Ian Kennedy that is.

According to a Reuter’s report, “The healthcare spending watchdog NICE said it was reviewing how it values new technologies, a week after an industry report called for such a move.” NICE's announcement followed an industry report published last week calling for an enquiry to assess the long-term impact of NICE on the cost and the uptake of drugs, along with a series of tax breaks and other measures to support the crisis-hit biotechnology industry

The study (due this July) will be led by Ian Kennedy, Emeritus Professor of Health Law, Ethics and Policy at University College London.  He’s an academic lawyer who, for the past few decades, has lectured on the ethics of medicine.  A long-standing member of the General Medical Council, he is a former president of the Centre of Medical Laws and Ethics, which he founded in 1978.

On a releated note, the Pink Sheet reports that, “Third-party payer policies appear to have an effect on clinical trial participation, but the impact "is difficult" to quantify, according to a draft report by Duke Evidence-Based Practice Center researchers prepared for the Agency for Healthcare Research and Quality.”

The draft report, "Horizon Scan: To What Extent Do Changes In Third-Party Payment Affect Clinical Trials and the Evidence Base?" was posted on AHRQ's technology assessment Web site. Comments on the draft are due Jan. 23. The topic is of interest because there is no consensus on financial responsibility for clinical trial-related health care costs, resulting in uneven reimbursement policies. A lack of adequate coverage for those costs may discourage patients from participating in trials, reducing the body of available clinical evidence.

A 2000 survey of nearly 6,000 cancer patients who were aware of clinical trial availability revealed that about 75 percent chose not to participate, with 20 percent of that group citing uncertainty about insurance coverage as the reason for declining participation. The top responses given for not entering into a clinical trial were: standard treatment was believed to be better (37 percent) and fear of receiving a placebo (31 percent).

Yet another unintended consequence of cost-based versus patient-centric reimbursement policies.

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Partial Sunshine With No Sign of Clearing

01/27/2009 02:14 PM |

What’s better than 1 FDA?  How about 50.

That would be the result of language inserted into the 2009 version of the Kohl/Grassley Physician Payments Sunshine Act. 

New language in the bill proposes to give states authority to require disclosure or the reporting of information not required by the FDA.

Result:  50 state FDAs … and chaos.

Chaos for drug companies, certainly.  But even worse -- chaos for patients and physicians.  Imagine a doctor in New York getting different information on a medicine than a doctor in Michigan.  Imagine a patient in Vermont getting different treatment than a patient in Arizona because their physicians weren’t sure who to listen to or what directions to follow.

Talk about emasculating the drug label.

And who should pharmaceutical companies go to with data and questions?  50 state health commissioners who may or may not have ever even looked at clinical trial data?  Are there any state health commissioners who hold a technical candle to even a mid-grade FDA reviewer?  Is there a state in the Union that employs a biostatistician?  And how would states pay for these new professional employees?  Likely source is lucre from lawsuits.  And it's even more likely these professional services would be provided by outside “experts" --  the same folks who earn a nice living from being “expert” witnesses.

Speaking of expert witnesses, the Physician Payments Sunshine Act makes no provision for reporting fees earned for such activities.

That ain’t sunshine.  

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Sweden beyond the Welfare State

01/27/2009 10:18 AM |

As I mentioned in my presentation in Washington last October (“A Transatlantic Malaise”), politicians everywhere would do well to get the facts before referring to the Swedish model. As state provision of welfare services started earlier in Sweden, it also started creaking earlier, and alternatives emerged before relative to comparable countries.

New evidence of a healthy change in public opinion may be found in a survey released this week by our colleagues at Timbro. A positive result of the breakdown of the Swedish monopolistic health care system is that the young generation (especially age 16-29) looks with favour on private options in social services.

Try this for size:

- three out of ten people think that private financing may need to increase for health and elderly care
- about half of this population consider this a positive development, and the younger are the most positive: 55 per cent of people age 16-29, and 49 per cent of the age group 30-44 think this "rather or very good".

Perhaps more surprising is the figure for the population age 60 and above: 48 per cent (the same as for the overall population) of the oldest Swedes are rather or very positive (as a proportion of those who replied that private provision of welfare services will increase in at least one area).

Last but not least, 51 per cent also think it largely positive if citizens were able to access private insurance for welfare services, beyond what the state provides. (There was an ominous attempt in 2008 by the supposedly centre-right government to abolish this option.) And again, the strongest supporters are found among the 16-29 year-olds.

There is room for optimism in the home country of cradle-to-grave socialism.


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Stupak P.I.

01/27/2009 01:59 AM |

Stupak food safety investigation expanded to include Salmonella in peanut butter

WASHINGTON - U.S. Congressman Bart Stupak (D-Menominee), chairman of the House energy and commerce subcommittee on oversight and investigations, and full Committee Chairman Henry Waxman (D-California), yesterday expanded the subcommittee’s food safety investigation to include the recent salmonella outbreak attributed to peanut butter.

The subcommittee on oversight and investigations held 16 hearings on food and drug safety over the past two years, including two involving a 2007 outbreak of salmonella from peanut butter.

Stupak issued the following statement:

“My subcommittee’s two-year investigation into the safety of our nation’s food supply essentially began when peanut butter contaminated with salmonella was discovered in February 2007,” Stupak said. “Today our investigation has been expanded to include the latest outbreak involving salmonella in peanut butter, which has sickened at least 448 people nationwide including 25 in Michigan.‬‪

“We have held 16 hearings over the past two years on food and drug safety, and have drafted legislation to provide the FDA the regulatory and financial tools to protect the American people. Food safety will remain a top priority for the Subcommittee and I remain committed to advancing legislation to address the weaknesses that allow 76 million Americans to be sickened by food borne illness every year.”

Good thing  he is on the case.  And good thing he has requested more money for the FDA in this latest disgorgement of tax dollars.

By the way salmonella happens all the time.  It's not the result of FDA oversight or lack thereof now or in the past...The idea that food borne illneses be prevented by putting more FDA cops in facilities is absurd.  And in terms of value per dollar spent how about investing in the Critical Path to pursue personalized medicine instead of spreading fear about peanut butter. 

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Dr. Offit Under Siege By Anti-Vaccine Zealots

01/26/2009 07:33 PM |

The New York Times reports that Dr. Paul Offit, the author of “Autism’s False Prophets,” is facing death threats for writing a book discrediting the supposed link between vaccines and autism.
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Pfizer, Wyeth and "P-Value"

01/26/2009 01:15 PM |

No doubt there is much yet to be written about the Pfizer/Wyeth deal.  But going forward, it's good to see that the key word of the day isn't "profits" or "patents" or "promotion" or "PhRMA" (which will now have one less dues-paying member) -- but "patients."

Here's the verbiage straight from the press materials:

For Patients Today – Broad Range of Health Care Solutions and Treatments: The new company will offer customers and patients a broad range of products for every stage of life.  Unique and valuable insights will be gleaned from a portfolio that spans wellness and preventive care, such as vitamins and vaccines, as well as therapies for a wide range of illnesses and diseases, such as Alzheimer’s disease and cancer.  We will leverage research across our portfolio and input from an extensive network of customer, physician and stakeholder relationships to accelerate, improve and expand the health solutions and treatments we offer.

For Patients Tomorrow – Robust Discovery and Development Program: The new company will have more resources to invest in research and development than any other biopharmaceutical company.  We will have access to all leading scientific technology platforms – enhancing the opportunity to produce significant breakthroughs in key disease areas.  As a result, we will be better able to help patients and invest in pursuing multiple avenues to address a wide range of unmet health needs.

At All Times – A Patient-Centric Business: We will operate small, distinct business units tailored to patients and customers that also benefit from being part of a premier global organization.  Each business unit will oversee product development from early stage research to clinical trials to commercialization.  This approach will allow for more customer input into the development process, rapid decision making and a better use of resources.  As a result, we will have the ability to invest in long-term opportunities while optimizing near-term patient access to existing products.

"Patients Today."  "Patients Tomorrow."  "Patient-Centric."  That's what I call real p-value.

The words are right.  Now let's see what happens. 

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