Latest Drugwonks' Blog

Parallel-o-gram

  • 10.10.2008

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.

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.

 

Suppose that a new study about an "intervention" showed that those exposed had a 50% likelihood of emotional exhaustion and depersonalization, with 11% occurrence of suicidal ideation. Those figures are frightening at face value - and were it a new drug associated with those findings. One would expect both FDA restrictive actions and congressional hearings to be likely responses.
 
In fact, those observations were reported last month in the Annals of Internal Medicine (149: 334) by Dyrbye and colleagues - their article was entitled "Burnout and suicidal ideation among U.S. Medical Students". This publication was based on a survey of students about the phenomenon of burnout and related concerns, with several interesting outcomes of potential utility for school administrators. 
 
For purposes of this discussion, it is tempting to speculate that a "proportionate response" for these findings of medical student risks and those of similar "side effects" from a drug would not be contemplated...... can you picture "recalls" and closures of med students programs until the risks were better understood and improved detection and management practices put in place? It's also interesting to look at the relative inattention of the lay media to this study as a puzzling juxtaposition to the amplification of any new drug safety report (regardless of validation), for findings of much lesser magnitude..... certainly, young doctors are not viewed by the press as merely "necessary fodder" for the war against disease. But some alternate explanation for their silence on this matter is not clear.
 
Having been a survivor of medical training "last century" during a time when on call hours and similar demands were likely more onerous than at present, it comes as no surprise that health care occupations with high stress job content can be challenging at best and threatening at worst; such conditions deserve more careful attention by training programs (beyond just having applicants sign informed consents that "med school may be hazardous to my health").
 
If one searches for root causes to the apparently disparate reaction to suicidality findings from drugs versus stress, it is possible that, similar to lay public understanding of diseases, the perception of dread is inversely proportionate to actual risk - people tend to fear that which we do not fully comprehend and do not believe we can control - and respond disproportionately. This skewed observational bias is also documented in public views of the actual versus perceived risk of hepatitis vs. AIDS, and in the proportionate attention given in the press to what is dreaded vs. truly threatening.
 
Perhaps current efforts by regulators and industry to provide more balanced attention to benefit-risk considerations will pave the future path to uniformly tempered responses to any new findings with drugs or other factors; until that time, our public health policy views will continue to be whip-sawed by amplification of every isolated factoid out of context - let's all endeavor to model that kind of balance going forward.

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,"

Read More



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.




Pink Ribbon Reality

  • 10.07.2008
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?

Legends of the Fall

  • 10.06.2008

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]  

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.

 

Mass Insanity

  • 10.06.2008

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.

Mighty Joe Antos

  • 10.04.2008
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.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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