Equity vs. Equality

10/15/2008 02:26 AM |

Today the Center for Medicine in the Public Interest (CMPI) held a conference entitled, "Physician Disempowerment:  A Transatlantic Malaise."

The opening keynote was Francois Sarkozy, MD (yes, the brother of the other Sarkozy).  Among his provocative comments was the thought that, when it comes to health care "as a right" we need to distinguish "equality from equity."  Further, Dr. Sarkozy discussed the attempts by the French government to reform healthcare by via decreased centralization.  At a time when many here in the US are calling for precisely the reverse, it certainly calls into question the prevailing "SiCKO" mentality of healthcare reform.

Dr. Sarkozy also presented a videotaped interview with the French Minister of Health, Madame Roselyne Bachelot, who spoke on the need for more cooperation between the public and private sectors as well as progams to better empower physicians to deliver the care best care to their patients based on their best medical judgment.

Mais oui!

Swiss physician, Dr. Alphonse Crespo spoke of the "pencil" strike that brought the Swiss healthcare authorities to their knees.  Young physicians and many general practitioners, protesting the healthcare policies of the government, continued to see patients -- but refused to fill out the requisite paperwork.  Talk about cruel and inhuman punishment.

Jacob Arfwedson, CMPI's Paris bureau chief, in a discussin of healthcare technology assessment asked the question, "Is evidence-based medicine at odds with evidence-based policy?"  Hmm.

And much more from the likes of Brian Lee Crowley (Atlantic Institute for Market Studies), Scott Gottlieb (AEI), Michael Weber (CMPI), Harvey Bale (immediate past Director-General of IFPMA), Marc Siegel (CMPI), Gary Applebaum (CMPI), and others.

We will shortly post the complete video proceedings of this event.  Watch this space for further details.


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Giving Tax Credits Where Credits Aren't Due

10/13/2008 07:57 PM |

According to PxReporter...

"Developers of companion diagnostics products, integral to the advancement of personalized medicine, may receive a much-needed financial boost from Congress covering their research and development expenses if a new bill introduced by Rep. Patrick Kennedy (D-RI) passes.

 

The Genomics and Personalized Medicine Act of 2008, H.R.6498, would award “an eligible taxpayer [or test developer] the companion diagnostic test credit” in “an amount equal to the qualified research expenses paid or incurred by the taxpayer during the taxable year, in connection with the development of a qualified companion diagnostic test.”

Not so fast. The credit is offset against any expensing of R&D activities on corporate returns. And the carry forwards on the credits are non-existent as far as I can tell but I am no tax lawyer....

Meanwhile the bill, while well intended, creates new agencies, work groups and layers of review for a personalized diagnostic climb through before it gets approval, thereby adding to costs that can't be claimed under the credit itself.

Are tax credits the only thing pols can come up with to promote innovation?

Why not, for instance, build on the work of the C Path Institute?

"Last October....the C-Path Institute announced that it will use a $2.1 million Arizona state grant to help Ventana take a lung cancer diagnostic through the FDA and standardize a regulatory pathway for companion diagnostics and therapies [see PGx Reporter 10-17-2007].

 

Or support the Critical Path by funding Reagan Udall....

Johns Hopkins University’s Genetics and Public Policy Center’s Gail Javitt notes: “New committees and layers of bureaucracy are proposed when what is needed are concrete steps to enhance oversight and improve laboratory and test quality. …"

Let's hope clearer minds and the Critical Path prevail...

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How To Create Health Care Shortages

10/13/2008 03:43 PM |

For those eager to use the current response to the contraction in the credit markets to justify an expanded government role in running health care, there's a difference between injecting capital into the financial system and price controls folks. Capital formation is a result of creating incentives for risk taking and profits. Price controls and redistribution repackaged as "investment" does not have the same effect. The same goes for the claim that a stimulus package that includes more money for Medicaid will help grow the economy. If that was the case, an increase in the murder rate would be a stimulus policy because it would lead to higher spending on trauma care.

Meanwhile the hero of the Far Left -- Hugo Chavez -- provides a preview of how health care will fare under Obama and others in Congress seeking to cut Medicare spending through price controls and rebates:

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The Bermuda Triangle of Research and Resources

10/13/2008 11:00 AM |

If you want to see the future of pharma/academe collaboration, then the current edition of Intensive Care Medicine is a must read. The particular issue is the contentious debate over the role of the Eli Lilly & Co. drug, Xigris (drotrecogon alpha/activated – DAA), in severe sepsis.  But there are much larger issues at play.

Interesting Sidebar: The first Xigris Advisory Committee meeting was scheduled for September 12, 2001, but was cancelled for obvious reasons – and the Lilly team had to get back to Indy by bus.  It seems to have been worth the trip. (The rescheduled meeting was held on October 16, 2001 – and it was a lively one.)

Specifically, Lilly is conducting a placebo controlled study of Xigris in patients with septic shock, and the referenced study (PROWESS-shock) must have been a design nightmare given the past controversy -- in addition to the issues involved in conducting such a study while the drug remains commercially available. 

Here is the ICM article, “Design, conduct, analysis and reporting or a multi-national placebo-controlled trial of activated protein C for persistent septic shock.”)

But there are larger issues at play – such as a new model of academia-industry collaboration.  As Jordi Mancebo and Massimo Antonelli write in their ICM editorial:

“This month’s issue of the Journal contains a somewhat unusual article and two accompanying editorials.  The authors of the article are members of the steering committee of an on-going Eli Lilly trial on activated protein C for persistent septic shock.  They describe a number of steps that have been adopted in order to ensure transparency in disclosing financial conflicts, facilitate comprehension and interpretation of results, minimize possible risks, and maximize eventual benefits for patients.  This approach constitutes a new model of academia-industry collaboration.”

It’s also important to note that the academic steering committee will oversee not only the conduct of the trial (nothing new there) but will also write the study manuscripts.

Further on Mancebo and Antonelli write:

“The novelty here is the full disclosure of the process by which this study was designed, and a description of how it will be conducted, analyzed and reported.”

In a second ICM editorial, Peter M. Suter and Jukka Takala write about to who benefits from this “new model”:

“The primary objectives of each of the three stakeholders are quite different.  The pharmaceutical industry wants to make profit, but is also very much interested in bringing new products to the market (necessary for its sustainable development) and in innovation (which improves its image in the eyes of society).  Science is curiosity-driven, with the aim of furthering our understanding of human biology, physiology and mechanisms of disease, also to discover better ways to treat disease.  Finally, the objective of medicine is to help patients to get better quickly and to recover a good quality of life.”

Suter and Takala conclude:

“The investigators of the PROWESS-shock trial have made a laudable effort to introduce an improved model of collaboration between science, medicine and industry.  This approach could help to get us out of the image of a Bermuda triangle, where benefits of research and resources for health care disappear in a black hole or the wallets of a few.”

(This is the same Peter Suter who once said he wouldn’t give his own brother -- who had septic shock -- Xigris.)

As Mancebo and Antonelli write, “We welcome this unprecedented step forward.”

Amen.

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Parallel-o-gram

10/10/2008 11:15 AM |

According to the Financial Times:

“Drug distributors who arbitrage the price differences across the European Union could see their €4bn ($5.5bn) a year trade severely curtailed under proposed legislation set to be unveiled by the European Commission later this month. A document obtained by the FT includes rules to crack down on the trade in counterfeit medicines that would make it difficult for wholesalers legally to move pharmaceuticals across the EU's open borders. New rules would put tight restrictions on the repackaging of medicines, a process required to ensure the correct language and coding information is used on packaging and information leaflets.”

“The repackaging controls, drafted for Günther Verheugen, EU trade and industry commissioner, as part of broader reforms to laws governing the pharmaceutical sector, have been justified as a way to reduce the threat of counterfeit medicines, which the pharmaceutical industry says is a growing danger to patients' health.”

On the other side of the issue, Heinz Kobelt, secretary-general of the European Association of Euro-Pharmaceutical Companies, which represents parallel traders, said the Commission had been unable to provide any evidence that parallel traders had allowed counterfeit prescription medicines to enter the pharmacy chain.

Heinz has a very selective memory.

Earlier this year, at a London policy conference on parallel trade (where we both spoke), Heinz pointed out (correctly) that the recent spate of counterfeit drugs that had infiltrated legitimate UK pharmacies had been discovered by a parallel trader. And that’s true. But what he didn’t mention (and seems to have again conveniently forgotten) is that those same products had already passed through three other parallel traders without being found.

Oops.

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The Young & the Restless

10/08/2008 06:00 PM |

According to a new survey, “Millennial” voters (18-28 years old) -- often are portrayed as the new “driving force” in American politics -- place health care reform fifth on their list of electoral issue priorities (behind the economy, energy/gas prices, jobs/unemployment, and Iraq). But, when millennial voters are engaged on the issue of health care reform they have some very strong – and often contradictory – opinions about reform -- particularly when it comes to issue of “universal care.”

The Center for Medicine in the Public Interest (the public policy institute home of www.drugwonks.com) has just released a new survey of millennial views on health care reform. The national public opinion poll of young voters demonstrates limited acceptance for the potential consequences of greater government control over health care.

While millennial voters report to strongly support the need for reform and the concept of “universal care,” when asked if they are willing to pay higher taxes to pay for a government-run health care system, their level of support swiftly turns in the opposite direction.

Millennial voters are strongly against government-care that results in longer wait times to see a health care provider, limits to the types of treatments and medicines they can access, and the potential for the government to interfere in the decision making and relationship between doctor and patient.

Some germane findings:

* A majority (75 percent) of millennials were concerned about their current and future ability to access affordable health care

* Eighty-three percent of millennials believe that America’s health care system is in need of reform and that health care insurance should be available to all Americans; and,

 

* Seven in ten millennials support the creation of a new government program to manage and administer public health insurance coverage options, and 6 in 10 were okay with increasing government spending to support health care reforms.

However, as the potential cost of health care reform was shifted directly onto individuals and not the government the level of support for reform ideas also shifted among millennial voters.

* A majority (51 percent) were not in support of any health care reforms thatcould raise their personal tax burden;

 

* Sixty-two percent said they would not support any health care reforms that could increase wait-times to see a doctor or the availability of treatments and medicines; and,

* Millennial voters were also equally unsupportive (62 percent) of health care reforms that would increase the role of the government regulation and oversight in doctor-patient decision-making.

This healthcare “idealism gap” among millennial voters speaks to a large divide between what this group is hearing from politicians and pundits -- and what they are willing to accept. This insight into how younger voters think and feel about these healthcare reform shows that all sides of the debate need to do a better job educating this important voting bloc about how various reform plans will impact the future of medicine in America.”

For further details please go to www.biggovhealth.org.

This poll is the result of 1001completed interviews with adults 18-28 years of age who are registered to vote.  Respondents were selected at random from the 48 contiguous states.  The interviews were conducted between September 12th, 2008 and September 20th, 2008. The margin of error for this study is ± 3.09 percentage points at the 95% confidence level. Interviews were monitored at random. 

Sampling for this study was conducted using a national probability sample of all exchanges and area codes across the 48 contiguous States.  All interviews were conducted using a computer assisted telephone interviewing system.  Statistical weights were designed from the United States Census Bureau statistics.

 

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Taking a Stab at Inconsistencies in Suicidality Perspectives

10/08/2008 02:27 PM |

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Healthcare Half Truths

10/08/2008 04:06 AM |

The depths to which Barack Obama stooped to distance himself from the elements of his own health care proposal was astounding. No mandates or taxes on small businesses? No price controls on insurance companies (just making sure they pay their claims and cover what they say they cover)? I won't even go into the distortion of the claim that McCain proposes "eliminating" state regulation of insurance companies any more than Obama does by setting up a national marketplace.

Then he keeps on claiming he can reduce premiums by $2500. An exaggeration that is on the verge of a lie... Half of that is supposed to come from costs generated fromo electronic health records! But his estimate of "savings" from EHRs is based on productivity gains which themselves are estimates drawn from private sector examples in the auto industry over ten years. The other amount comes from "disease managment" savings achieved by getting doctors to practice guideline driven medicine. That's called rationing. Also unlikely. And even David Cutler, one of the smartest health care analysts in America acknowledges that the $2500 doesn't translate into reduce premiums:

Obama health adviser Cutler confirmed that the campaign's $2,500 per family projection doesn't represent only out-of-pocket savings for individual Americans. It includes savings to the government, employers and insurers, savings that could, Cutler says, trickle down to families in the form of lower taxes, higher wages or reduced premiums. In fact, Cutler says the $2,500 figure simply comes from dividing an overall savings estimate that's somewhat larger than $120 billion by an approximate number of four-person families in the U.S. "[W]e take the total and divide by the total population, then consider a 4 person family,"

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The "Pink Ribbon" of Health Care Reform

10/07/2008 05:36 PM |

Barack Obama:

“I happen to be a proponent of a single payer universal health care program.” (applause) “I see no reason why the United States of America, the wealthiest country in the history of the world, spending 14 percent of its Gross National Product on health care cannot provide basic health insurance to everybody. And that’s what Jim is talking about when he says everybody in, nobody out. A single payer health care plan, a universal health care plan. And that’s what I’d like to see. But as all of you know, we may not get there immediately. Because first we have to take back the White House, we have to take back the Senate, and we have to take back the House.”

Barack Obama on single payer in 2003

Guess what

Mammograms: 88.6% of American females 40-69 had ever had a mammogram compared to 72.3% of Canadians.
Women are ten percent less likely to survive five years with a breast cancer diagnosis in Canada and 20 percent more likely to die from breast cancer in Canada. If rates were adjusted for race and stage the difference would likely be higher.

Though the breast cancer drug Herceptin was approved in 1998 it was first used in Canada in 2005 and even then it's access to high responders was rationed.

Read more here


Change we -- and women with breast cancer -- don't need.




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Pink Ribbon Reality

10/07/2008 01:38 PM |

Will healthcare be discussed during tonight's presidential debate?  Smart money says "yes."

So does hopeful money -- since October is Breast Cancer Awareness Month.

That being the case, which candidate deserves to wear the Pink Ribbon?

A few questions to consider before answering:

Which candidate supports a platform that would accelerate the pharmaceutical community and the FDA down the Critical Path? 

Which candidate supports a program that believes in getting women with breast cancer the most appropriate care as early in their disease state as possible?

Which candidate supports a program that understands the value of incremental innovation and the "price/value" equation?

Will either candidate speak up for "the four rights" -- the right medicine for the right patient in the right dose at the right time?

Will either candidate wear a pink ribbon tonight?

Will either candidate wear a pink ribbon for reasons other than optics?
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Legends of the Fall

10/06/2008 03:27 PM |

Barak Obama's campaign released a horribly misleading ad about McCain's health care proposals, claiming that it would lead to millions losing health care coverage, raise taxes and hand over cash to insurance companies. 

The claims have failed every fact-check – from CBS[1] to the Washington Post.[2] John McCain is not going to raise taxes on middle class families....

Transforming The Tax Code To Create Greater Equity: The McCain plan transforms the current tax code to provide all American families – including the self-employed and the uninsured – the same tax benefit, a $5,000 refundable tax credit ($2,500 for individuals) that was previously only available to those with employer coverage. Families can use this credit to purchase insurance of their choice, including keeping their current coverage. This is an approach supported by Barack Obama's own Senior Economic Advisor Jason Furman who wrote that "we could scrap the current deduction altogether and replace it with progressive tax credits that, together with other changes, would ensure that every American has affordable health insurance."[3]

·         Better Than "Members of Congress":  Under the McCain Plan, your employer can provide you with health insurance  as good as a "Member of Congress", and you would pay no  more in taxes – regardless of your tax bracket.  In fact, you would have some additional money left over from the McCain tax credit to put in a health savings account.

·         On The Issue Of the Congressional Plan – There Are Options, But All Are Under The FEHB Program: A good example is the Blue Cross and Blue Shield Service Benefit Plan, which has combined monthly premiums for family coverage of $1027.95, for an annual cost of $12,335.40.

	Income Tax Liability	McCain Tax Credit	TOTAL Tax Savings
10% Bracket (Up to $15,650)	$1,200 ($12,000 x 10%)	$5,000	+$3,800
15% Bracket ($15,650 -63,700)	$1,800 ($12,000 x 15%)	$5,000	+$3,200
25% Bracket ($63,700-128,500)	$3,000 ($12,000 x 25%)	$5,000	+$2,000
28% Bracket ($128,500-195,850)	$3,360 ($12,000 x 28%)	$5,000	+$1,640
33% Bracket ($195,850 -349,700)	$3,960 ($12,000 x 33%)	$5,000	+$1,040
35% Bracket (349,700 and over)	$4,200 ($12,000 x 35%)	$5,000	+$800

 

·         Where Is The Middle-Class "Tax Increase"?   If you or your family is in the 28% bracket, with an income of $180,000, you could receive employer provided health insurance even better than a Member of Congress, with a cost of almost $18,000, with no increase in taxes. Even the liberal leaning Tax Policy Center, agrees that the McCain proposals will result in a "net tax benefit" of more than $1,200 for an average tax payer.[4]   

·         Helping Those Without Employer Coverage:  If you are a  middle-class American today without employer provided health care, the McCain plan would give you a tax credit of $2,500 as an individual, or $5,000 for a family, to help you buy your own health insurance coverage, including across state lines. American families – not government bureaucrats or insurance companies – will choose the coverage that best meets their needs.  Today, the government does nothing to help you.  Why does Barack Obama oppose this?

·         McCain Health Plan Puts Families in Charge: In another desperate attack, Barack Obama and Joe Biden have said that McCain health care tax credits to help families buy coverage "will go straight to the insurance company." Here is what they fail to mention – the credit goes to the insurance company that the American family chooses to get coverage from, anywhere in the nation. The power of choice lies with the family – not government bureaucrats or insurance companies.  Ridiculing this line of strange attack, The Associated Press stated, "Of course it would, because it's meant to pay for insurance. That's like saying money for a car loan will go straight to the car dealer."[5] Furthermore, any additional money left over after purchasing coverage will be controlled by the family in a portable health savings account.

·         McCain Health Care Plan Protects Our Vulnerable Population: John McCain believes that no American should be denied access to quality and affordable coverage simply because of a pre-existing condition. As President, John McCain will work with governors to develop a best practice model that states can follow – a Guaranteed Access Plan or GAP – that would reflect the best experience of the states to ensure these patients have access to health coverage.[6] There would be reasonable limits on premiums, and assistance would be available for Americans below a certain income level.[7]

·         McCain Health Care Plan Gives American Families More Choices: John McCain believes that American families should be given more choices by allowing them to purchase policies across state lines. In a move derided by fact checking organizations including Fact Check, the Obama campaign used this as an opportunity to falsely accuse John McCain of deregulating health care markets akin to Wall Street.[8] A recent study showed that simply allowing Americans to purchase across state lines would reduce the number of uninsured by almost 12 million.

·         McCain Health Care Plan Preserves Employer Coverage: The McCain health plan builds on the employer-based system. Employers will have the same incentive to provide health insurance as they do today since they will continue to deduct the cost of health insurance they provide to employees. Nothing will change. In addition, payroll taxes will be protected from taxes under the McCain plan. Millions of American families with employer sponsored coverage in all tax brackets with the same coverage as a "Members of Congress" will now come out ahead with additional funds going into a portable health savings account. Importantly, younger and healthier employees with the McCain health care tax credit will have a bigger incentive to stay with the employers. For example, a 25-year-old employee in the 25 percent tax bracket with a $2,500 tax credit could either purchase a policy in the individual market for the same amount or stay with his employer plan and receive a $5,000 policy with an additional $1,250 to invest in a portable health savings account.  Why would people choose worse insurance and less money? Finally, the McCain plan through comprehensive cost-containment policies addresses the single biggest threat to employer coverage – rising costs.   

The truth about Senator Obama's health plan:

·         Barack Obama's Plan Continues The Push Toward Government-Run Healthcare: The Obama plan will create a brand new government-run health plan at the cost of $243 billion a year – a financial burden of more than $3,000 a year on American families.[9]

·         Barack Obama's Plan Will Harm Employer Coverage: The Obama plan includes a $179 billion a year employer mandate.[10]  The mandate requires employers to either provide "meaningful" coverage or pay a tax towards the government plan.[11]  Faced with tough economic conditions and rising health costs this creates a clear incentive for employers to drop coverage and move families into the new government plan. A Lewin Group study which examined a similar employer mandate combined with a national plan, like the Obama plan, concluded that almost 52 million individuals would lose their private employer coverage.[12] To maintain their competitive edge, others employers will follow - spelling the demise of the employer coverage system.

·         Barack Obama's Plan Will Damage Private Coverage: The government-run plan will have a clear advantage over private insurance since it will be subsidized by American taxpayers. A recent analysis of both plans by the nonpartisan CATO Institute concluded that the Obama government-run plan will be able to "keep its premiums artificially low…since it can turn to the U.S. Treasury to cover any shortfalls" resulting in "undercutting the private market."[13] According to Wall Street Journal, the goal of the Obama plan "…like HillaryCare in the 1990s, is to displace current private coverage and switch people to the default government option."[14]  

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How about all those Generic Sampling Programs?

10/06/2008 02:46 PM |

Interesting story in today’s New York Times. Here’s how it begins:

"A new study suggests that free drug samples, an effective marketing tool for the drug industry, do little to help the poor and may put children’s health at risk.”

“… do little to help the poor …”   Really? 

No.  According to the report (published today in Pediatrics), once in a doctor’s office, children who do not have health insurance are more likely to receive free drug samples than children with health insurance. And here's the important context part -- children in the lowest income group were no more likely to receive the samples than were those in the highest income group, in part because the poor are less likely to see doctors.

So how do free samples “do little to help the poor?”  Is there some sort of socio-economic biomarker we need to know about?

Skip to next paragraphBut, “… of greater concern, the authors wrote, are the kinds of drug samples that physicians provide.”  Indeed, the issue of pediatric safety is an important one, but all drugs have risks as well as benefits -- and the Precautionary Principle isn't going to help poor kids get better any faster.  But what it will do is create even wider health disparities.   It's also important to note that the report does not conclude that free samples are causing pediatricians to inappropriately prescribe anything. 

According to the Times, “The study’s lead author, Dr. Sarah L. Cutrona, an instructor at HarvardMedicalSchool, said in an interview that the drugs provided as free samples tended to be the newest, so their safety had often not been thoroughly vetted.”

Hey, what about all those generic sampling progams?

The Times interviewed Dr. Andrew Racine, director of general pediatrics at the Children’s Hospital at Montefiore in the Bronx.  He believes that free samples distort doctors’ decision-making. According to Dr. Racine, “This is just a marketing technique.”

Of course sampling is a marketing technique. But does this make sampling deliterious to pediatric health?  That’s the implication (the headline of the story is "Study says Drug Samples May Endanger Children"). 

"Just" a marketing technique?  What about the therapeutic benefits?

Another pediatrician interviewed by the Times, Dr. Lisa Asta of Walnut Creek, CA, said she's considering banning free samples from her practice because the drugs being promoted generally required high co-payments.

This is another important issue – but the answer is not to provide second class care to one cohort of children and a higher quality of care to another.  And banning samples doesn’t make things better -- it exacerbates the problem.

Click here for the complete story in today’s New York Times.

 

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Mass Insanity

10/06/2008 01:23 PM |

Last month two Massachusetts scientists won the Albert Lasker Medical Research Award. Commonly called "America's Nobel Prize," the Lasker Award is the country's most prestigious honor for medical breakthroughs. It was given to BayState biologists for their work on gene expression, the results of which show unprecedented promise in the efforts to combat disease.

The win is a testament to the strength of Massachusetts' medical research community. Yet local legislators have recently instituted a law likely to undermine the inter-industry partnerships essential to just this sort of cutting-edge scientific discovery.

In August, Gov. Deval L. Patrick signed a bill requiring pharmaceutical firms to report to state officials any payments over $50 made to physicians, academic scientists, or other medical professionals. The information - including the names of the people getting paid - will be posted on a public Web site. The bill goes into effect Jan. 1, and provides for fines of up to $5,000 for non-compliance.

This disclosure law is supposed to increase transparency. State officials are understandably worried that money from drug makers could unduly influence research results or physicians' practices. And they want to ensure that patients know if their healthcare provider has a financial incentive to recommend certain treatments.

 
But publishing this information suggests that there is something wrong with medical professionals working with the pharmaceutical industry. There isn't.

Physicians rely on drug makers for up-to-date information about new treatments. Drug makers in turn rely on doctors for feedback on the real-world clinical effects of their pills - the kind of information that can't be acquired in a laboratory.

The law is also unnecessary. This summer, the drug industry announced strict new limits on sales personnel, banning them from buying lavish meals or giving gifts of any sort during meetings with physicians. Since physicians are often only available for non-patient work during lunchtime, sales reps will only be allowed to pay for the occasional modest meal at a doctor's office, as long as it's "in conjunction with informational presentations."

And under the new guidelines, sales reps are strictly prohibited from passing along information that is anything other than educational.The BayState's disclosure law will stigmatize the doctors it publicizes. Many might leave Massachusetts in favor of a state with a healthier regulatory environment. That would make a bad situation worse: Nearly a quarter of the state's physicians are already considering leaving or are planning to leave because of legal controls on clinical practices, according to a Massachusetts Medical Society report.

The law will also have a dampening effect on academic medical research.

Funds provided by private firms don't compromise lab work they're essential to getting the research off the ground in the first place. Many of Massachusetts' academic medical centers are currently conducting research in partnership with pharmaceutical companies.Scientists are likely to give up on research projects that require corporate sponsorship for fear of jeopardizing their reputations.

Biopharmaceutical companies employ around 55,000 Massachusetts residents, according to the Center for Labor Market Studies at Northeastern University. If researchers start leaving the state to avoid stigmatization, investment dollars and jobs will follow. And that means fewer breakthrough cures from the commonwealth.

Ironically enough, this law's passage comes at a time when state legislators are making a concerted effort elsewhere to bolster the BayState's medical research industry. In June, Gov. Deval L. Patrick approved a 10-year, $1 billion biotechnology initiative, meant to expand investment in state-level research projects.

This new disclosure law hinders those efforts. It will stifle life science innovation, choke off investment dollars into new cures, and destroy medical sector jobs. Patients, physicians, researchers, and average citizens alike should be outraged.

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Mighty Joe Antos

10/04/2008 03:10 PM |

Check out our latest video podcast featuring the brutally honest observations of AEI's Joe Antos.

Check here and then click on the smart looking guy in the maroon-striped tie.

Here's a taste, "We have to stop walling-off reality when it comes to discussing healthcare reform."

Say it ain't so, Joe.
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Katie Couric: A Front For Trial Attorneys?

10/04/2008 01:16 AM |

It seems that Sarah Palin isn't the only target for Katie Couric and CBS News...

In recent years Katie and her crew have gone after vaccine makers and the make believe link between vaccines and autism, taking up the cause of trial attorneys on the one hand and glossing over the scientific data demonstrating no relationship on the other...

Back in June 2007, “CBS Evening News” featured a story titled “Vaccines suspected in rise in autism rates.” CBS News correspondent Sharyl Attkisson reported on the hardships of the parents of an autistic child and their fight to win money from a federal fund for “vaccine damages.”

“Twelve-year-old Michelle Cedillo doesn't know it, but she's the center of a landmark case that started today in federal vaccine court, one that could open the door for thousands of autistic children to be paid by a government fund,” Attkisson said on the June 11, 2007, “CBS Evening News.” “The controversy: whether their autism was caused by their childhood shots.”

Seven months later, the study, supported through the California Department of Public Health according to a press release, got little fanfare. It got only a brief mention on “CBS Evening News,” despite CBS airing six stories over the past two-and-a-half years that sounded alarm bells over thimerosal, according to a Nexis search.

One CBS story, aired on July 15, 2005, included the ranting and ravings of environmental extremist Robert F. Kennedy, Jr. “The science connecting brain damage with thimerosal is absolutely overwhelming,” Kennedy said.

See here.

In June of 2008, Attkisson was at it again, this time trying to discredit scientists and organizations who support immunization because they receive support from vaccine companies (ignoring the fact that Robert F Kennedy and others she provided fawning coverage for are on the trial attorney take...) Here's the lead into a story on Katie's show one month after the California study came out:

"For years some parents and scientists have raised concerns about vaccine safety, including a possible link to autism and ADD. Many independent experts have sided with government officials and other scientists who say there's no possible connection. But how "independent" are they? "

http://www.cbsnews.com/stories/2008/07/25/cbsnews_investigates/main4296175.shtml

Now it turns out that Katie is bringing another reporter into her stable with close ties to trial attorneys whose history is writing about health litigation issues – principally sourced from class action litigators, Heather Won Tesoriero.

Heather Won Tesoriero is brand new to CBS and this is probably working now on her very first stories. At the beginning of September she joined a leading talent agency ( N.S. Bienstock) which helped her move from medical and law reporter at the Wall Street Journal to CBS NEWS as a field producer covering medical issues. It appears she’s trying to make a big leap and name for herself with Katie Couric. Will CBS and Couric become the latest platform for Tesoriero’s history of big class action law firm-sourced attacks? If Atkisson's autism crusade is any indication what's to come, the answer is yes.

While a WSJ staff health reporter and blogger she primarily focused on medical-related fraud/litigation issues and is clearly well-connected to the plaintiff’s attorneys side quoting their claims and interviewing them unchallenged on WSJ-TV. She was “co-counsel” for the WSJ Law Blog. She’s done several reports on drug side effects (clearly promoted by class action litigators), some environmental-linked health claims and other purported health fraud topics. No one should be surprised if she brings the same sources, bias and unbalanced reporting to CBS.

Links to other related stories written by Tesoriero on behalf of class action litigators:

· Oil Firms Settle Claims In MTBE Leak Cases – article

· Video interview with plaintiff attorney by Tesoriero on MTBE leak

· Patients Sue Icelandic Drugmaker Over Recalled Heart Drug

· Health-Care Fraud: Keep an Eye on the Small Fry

· Wayward Medical Records Sold as Scrap Paper for $20

· Whistleblower Law Blog: Tesoriero and quitam lawsuit

· Vioxx Study Casts Doubt on Merck Claim

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Commonwealth Climbs in the Tank For Obama

10/04/2008 12:48 AM |

Only a small margin of voters believe that Obama's health plan will benefit them personally compared to McCain's plan.

See here.

So along comes the supposedly non partisan Commonwealth Fund with a report claiming that the Obama plan will do a better job in reducing the number of people without health insurance.

See here.

Unfortunately media reports ignore the fact that the Commonwealth Fund also produced a study this past summer "demonstrating" that something like the Obama plan would only cost $165 billion over ten years and touted the features of the Obama plan including a National Health Exchange, expanding Medicaid, subsidies for large corporations, etc.

See here.

Nothing like using the media to pass on a favorable review of your own proposal and as a springboard to jump into the tank with Obama.
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Fake Drugs ToGo

10/03/2008 07:27 PM |

From the New York Times:

Belgium: Shipments of Fake Pills Seized

Customs officers at the Brussels airport seized more than two million counterfeit pills on Thursday that were made in India and destined for Africa, officials said. Blister packs of the pills, above, which included counterfeits of Tramal, a painkiller, and of Fansidar, an antimalaria drug, were found in large bags, the customs service said in a statement. The pills were sent in three shipments by a company based in Mumbai and were bound for two companies in western Africa. Lieven Muylaert, spokesman for the Belgian customs department, told Agence France-Presse, “To our knowledge, this is the biggest seizure of counterfeit medicine ever carried out in Europe.”

From the BBC:

Belgians seize Africa-bound drugs

More than two million counterfeit drugs destined for Africa have been seized in Belgium, customs officials say.

They said the shipment from India, including copies of an anti-malaria drug, was the biggest seizure of fake medication ever made in Europe.

Customs officers at Brussels airport became suspicious when they noticed spelling mistakes on the labels.

 The UN says fake medicines represent 10% of the world market and up to 30% of the African market.

The seizure, made last week, was made public on Thursday night.

Hidden in large bags, the pills were copies of a strong painkiller made by a German company, and a Swiss-made anti-malarial treatment.

The confiscated medicines had been sent in three shipments by an Indian company in Mumbai, and were bound for two unnamed companies based in Togo.

Belgium's Le Soir newspaper reported that the drugs were probably intended to be distributed across West Africa.

"Thanks to this seizure, we have saved lives," Le Soir quoted Lieven Muylaert, spokesman for Belgium's customs department, as saying.

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European Commission Calls for More Healthcare Cowbell

10/03/2008 01:45 PM |

Too slowly for some, too swiftly for others, and without any apparent interest by most, the European Commission is moving forwards in its efforts to lubricate the anemic channels through which pharmaceutical companies can communicate with patients (otherwise know as “people”).

According to an article in Europolitics, “The European Commission is standing firm on its objective of authorising pharmaceutical laboratories to communicate directly with patients on the benefits and risks of their prescription products.

The full Europolitics article follows – but here are some tidbits to whet your appetite:

 “The idea is also to respond to the expanding use of communication tools - in particular the internet - and patients' growing responsibility for their treatment.”

 Wow.  Reality.  What a concept!

 “While the Commission has always denied wanting to authorise advertising for prescription drugs, it was expected to make a clear distinction between non-professional information' and advertising' if the industry is allowed to communicate directly with patients.”

But:

“The EU executive took a step backwards, however, on communication channels: exit radio and TV broadcasting, which "does not protect patients against unsolicited information".

However:

“… the Commission intends to maintain the print media in its proposal. It nevertheless puts emphasis on the internet, saying it offers "almost unlimited access to information without taking account of national borders."

So, there can be advertising , but not advertising.

And for all you DDMAC fans out there:

“The European Agency for the Evaluation of Medicinal Products (EMEA), based in London, would also play a role: laboratories would have to notify their information prior to publication and the EMEA would have 60 days to express any compliance objections, after which the information would be published.”

And to make things even more confusing:

“For the monitoring of information, the Commission is expected to propose an ex-post mechanism (after dissemination of information to patients). The member states will define the rules. They could nevertheless set up prior monitoring - and clearance by the competent authorities - for information for which it is hard to make a distinction between non-promotional information' and advertising'.”

Note:  This is the difference between federation and confederation.  It is also a lesson in why concepts like … preemption ... are so important. But I digress.

Here is the compete article from Europolitics:

Prescription Drugs: Pharmaceutical Firms Authorised to Inform Patients

The European Commission is standing firm on its objective of authorising pharmaceutical laboratories to communicate directly with patients on the benefits and risks of their prescription products. In a draft directive due out in late October(1), the EU executive is expected to stand up to the criticisms of health care professionals, sickness insurance bodies and several patient and consumer organisations, which accuse it of trying to do away with the European ban on advertising for prescription drugs.

With this proposal (subject to co-decision), of which Europolitics obtained a copy, the Commission intends to iron out the differences between national laws, which range from allowing information that is strictly supervised by drug regulatory authorities, to public private partnerships between health care professionals, patient associations and industry.

QUALITY CRITERIA

While the Commission has always denied wanting to authorise advertising for prescription drugs, it was expected to make a clear distinction between non-professional information' and advertising' if the industry is allowed to communicate directly with patients. Its answer is that "the content of authorised information must be defined". According to the proposal, industry would be authorised to communicate on the instructions for drug use, prices, changes in packaging, warnings on side effects, the absence of scientific studies and prevention and treatment support measures. Information on human health and illnesses as such is not concerned.

Quality criteria are established: the information must be objective and non-biased, take patients' needs and expectations into account, be based on factual and verifiable data (declaration on the extent of evidence), up-to-date, reliable, factually accurate and not misleading, comprehensible to patients and the general public, stem from a clearly identifiable source and compatible with the summary of product characteristics and patient information brochures as approved by the competent authorities. Comparisons between drugs are prohibited.

INTERNET AND PRINT MEDIA

The EU executive took a step backwards, however, on communication channels: exit radio and TV broadcasting, which "does not protect patients against unsolicited information". This eventuality, discussed by the Commission in its public consultation documents, was rejected by the member states, even the most liberal stakes like the

UK, but also by laboratories. The European Federation of Pharmaceutical Industries and Associations (EFPIA), for example, had informed the Commission that its members did not wish to engage in direct advertising as in the United States and that reflection on passive information via TV, radio and the print media tied into that. However, the Commission intends to maintain the print media in its proposal. It nevertheless puts emphasis on the internet, saying it offers "almost unlimited access to information without taking account of national borders". And it adds that "specific rules on site surveillance should be put in place to take account of the cross-border nature of the information provided on internet and to allow cooperation between member states". Patients could, for example, write to industry in any of the EU's 23 official languages to request information in that language.

EX-POST MONITORING

For the monitoring of information, the Commission is expected to propose an ex-post mechanism (after dissemination of information to patients). The member states will define the rules. They could nevertheless set up prior monitoring - and clearance by the competent authorities - for information for which it is hard to make a distinction between non-promotional information' and advertising'. The national authorities will have to ensure that information is accessible to people with disabilities, unless this requires too much paperwork in laboratories. Such a regulated mechanism nevertheless does not rule out voluntary regulation by industry or co-regulation by industry and the public authorities. At a debate in the Health Council, on 10 June in

Luxembourg, most of the member states expressed a preference for prior monitoring of information. Sweden noted, however, that possibilities for ex-post monitoring could lower the administrative costs involved (see Europolitics 3548).

It will also be for the member states to ensure that companies are fined or taken to court for "repeated and serious cases of non-compliance" with the new rules. The name of the company would be made public. The European Agency for the Evaluation of Medicinal Products (EMEA), based in

London, would also play a role: laboratories would have to notify their information prior to publication and the EMEA would have 60 days to express any compliance objections, after which the information would be published.

The Commission also gives itself the possibility to revise the directive five years after its entry into force. The proposal concerns only prescription drugs, since existing EU rules authorise advertising by laboratories for over-the-counter drugs, under certain conditions.

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Jenny McCarthy Can Promote Autism Cure But Docs Focus on OTC Cold Medicines

10/02/2008 05:02 PM |

Here's what happens when drug companies become a convenient whipping boy for media hungry public health officials and a pliant media plays along:

Jenny McCarthy has stated that with a change in diet and vitamins, her autistic son has been 'cured' - but some parents are not happy about her 'cure' statements. Jenny McCarthy's son, Evan, has been put on a special diet and has been receiving vitamin B-12 shots - and Jenny says the regimen is really working.



"I've been speaking to moms across the country who are all shouting out the same thing: 'This (diet and supplement intake) is working," Jenny says.

"It's so heartbreaking to see the medical community not support something called diet and vitamins. And it pains us, city after city after city. I see this heartbreak on these mom's faces."

Click Here to Read More

Related Article: 

"FDA urged to recall cold medicines for youngsters"

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Sarah Palin Revealed.....

10/02/2008 04:08 PM |

She has a real record on health care as I have noted before and compared to Obama's, it's much better...

Click Here to Read More
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