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One of the presumptions behind calls for wider access to health insurance is that over the last ten years more and more Americans have found themselves uninsured. But it turns out that this isn’t quite true. Sure, the number of uninsured Americans is higher now than it was a decade ago but the change has a lot to do with population growth. A far better measure is the percentage without insurance, which despite fluctuations, has not changed a lot since even the early 1990s. In fact, between 2006 and 2007, the last years for which there is good data, both the number and the percentage of Americans who are uninsured went down.

Uninsured Americans




And while obviously the recession that hit the US beginning last year has worsened the picture, a Gallup poll in June 2009 put the number currently uninsured at around 16 percent of adults. That is higher than in previous years, yes, but not shockingly or dangerously so. It also represents only those uninsured at one point in time and leaves out people under 18, who tend to have a higher rate of being insured, especially with the extension this year of programs like SCHIP.

I’m hardly going to argue that “only” 14-16 percent uninsured is a reason to leave the US health care system as is. However, both honesty and well-researched information have been lacking, on all sides, of the health care debate. The myth of the rising uninsured is yet another example of this.

Camp Counseling

  • 08.31.2009

In Sunday's edition of the New York Times, Robert Pear reported that:

“Medicare beneficiaries would often have to pay higher premiums for prescription drug coverage, but many would see their total drug spending decline, so they would save money as a result of health legislation moving through the House, the Congressional Budget Office said in a recent report.”

The "but" is at the very end of the article:

But, Mr. Elmendorf  said, the averages conceal the fact that beneficiaries would be affected in different ways.”

(That’s Doug Elmendorf, director of the CBO.)

And when you consider the, um, facts …

“Those who use a relatively small amount of prescription drugs would pay more in additional premiums than they would save, he said, while those who use a large amount of drugs would gain more from lower cost-sharing than they would pay in higher premiums.”

The CBO study was undertaken at the request of Representative Dave Camp (R, MI), the senior Republican on the House Ways and Means Committee.

Mr. Pear ends by reporting that, “The budget office did not estimate how many Medicare beneficiaries might see an increase in their spending for prescription drugs and drug coverage, and how many would see a reduction, under the House bill. Mr. Camp said “the vast majority of seniors” would pay more, and he said House Democrats should scrap their bill and “start over with open, bipartisan talks.”

The complete New York Times article can be found here.

What’s the problem with higher co-pays?  They reduce usage and compliance.  Great if you’re trying to save money in the short-term.  Not so great if you’re trying to enhance patient outcomes over the long-term.  Short-term-savings (a political objective) vs. long-term patient health (which is also much more cost-effective in the long-term).

Short-term (political) thinking delivers long-term (public health) problems.

According to a recent study by Wolters Kluwer Health, fewer Americans are filling their drug prescriptions. In the fourth quarter of 2008, U.S. patients neglected to fill 6.8 percent of on-patent prescriptions - a 22 percent increase compared to the first quarter of 2007. (On-patent prescriptions are those for which there is no generic alternative to the brand-name drug.)

Why?

Drug prices. It's not that the cost of prescription drugs is rising - it's patients' out-of-pocket costs, or co-pays. One of the reasons for this is that insurance companies, reluctant to foot the bill for brand-name medications, have been refusing to cover more brand-name prescriptions.

In the fourth quarter of 2008, in fact, health insurers denied coverage for 10.8 percent of brand-name drugs - a jump of 21 percent from the first quarter of 2007.

And it's not because the medicines themselves are becoming more expensive. Between 1998 and 2003, prescription drug costs increased by $22.48 per person. Meanwhile during that same period, the average health insurance premium went up by $104.62 per person.

When co-pays go up, more people see the need to abandon their prescription drug regimen. At least that's what a study from Oregon Health & Science University found. In 2003, researchers looked at what happened when a small $2 to $3 co-payment was introduced for Oregon Medicaid patients. After examining data on 117,000 patients, the researchers found that prescription drug use dropped by 17 percent.

As health care costs continue to rise, it's understandable that insurance companies (including the nation’s biggest payer – Uncle Sam) are looking to save money wherever possible. Passing off the cost of prescription drugs to patients, however, will only drive up overall costs while resulting in dramatically poorer health for more Americans.

The Week in Quotes

  • 08.28.2009
Economist Thomas Sowell on life expectancy rates and the health care debate:
 
“No small part of the current confusion between ‘health care’ and medical care comes from failing to recognize that Americans can have the best medical care in the world without having the best health or longevity because so many people choose to live in ways that shorten their lives.”
 
Howard Dean on the reason tort reform is omitted from the current House proposals:
 
“Here is why tort reform is not in the bill. When you go to pass a really enormous bill like that the more stuff you put in, the more enemies you make, right? And the reason why tort reform is not in the bill is because the people who wrote it did not want to take on the trial lawyers in addition to everybody else they were taking on, and that is the plain and simple truth. Now, that’s the truth.”
 
Chairman of the House Energy and Commerce Committee Henry Waxman on Medicare Part D:
 
“We want it back. We want to make sure the windfall for the drug companies does not continue, and we want to recover the money that has been a windfall.”
 
Henry Waxman on the deal between PhRMA and the White House:
 
“We don’t have any deal with them, and the whole enterprise of doing health insurance for all Americans isn’t to make the drug companies happy, or wealthier.”
 
PhRMA CEO Bill Tauzin’s response to Waxman’s efforts to recover a so-called windfall for drug companies as a result of Medicare Part D:
 
“You not only break the deal, but you break the bank for us.”
 
Senator Joe Lieberman (I-CT) on the ambitious health care proposals currently under consideration:
 
 
“We’ve got to think about putting a lot of that off until the economy’s out of recession. There’s no reason we have to do it all now, but we do have to get started. And I think the place to start is cost, health delivery reform and insurance market reforms.”
 
Senator Mary Landrieu (D-LA) on how to proceed with health care reform:
 
“I'd prefer a private market-based approach to any health care reform that would extend coverage. I'd like to cover everyone -- that would be the moral thing to do -- but it would be immoral to bankrupt the country while doing so.”
 
 

Reading responses to a recent piece on ideas for increasing transparency in industry support for continuing medical education, this particular comment stuck out to me:
 
All industries use corporate support to further continuing education. There should not be a ban on that. If we are going to cut the communication between the industry and professionals, then how on earth the new technologies can be introduced to professionals. The fight to prevent influencing the minds of physicians is going too far. Now we want the industry and physicians not to even see each other??? Does it not sound like the Taliban… too orthodox? I am a physician and I want to know what is going on in the healthcare industry. I want someone to tell me what new medicines are coming out of pipeline into the market. I do not have time to research it myself. Just because a physician saw it in a seminar does not mean they will not use it judiciously. Even ACP and other conferences have sections where they allow healthcare industry to show case what they got. Those who do not want to know the latest technology are actually doing a disservice to their patient. For example a recent drug was introduced in the market as an alternative to allopurinol for gout. I would not have known about it for many months, unless a drug rep had not come in and told me about it. I still write allopurinol, but in the back of my mind I know I have a second medicine to help my patients, if they need it.

Industry and Professional communication is very important for overall development of technology. The users have to be told what tools they have. Once we are out of school those opportunities are limited. There is just too much to do than just browse every single medical journal to see what’s new out there.

Every single day the fast food companies advertise on television and ask our children to eat cholesterol laden food which will make them obese. Every single day marketeers are ruthlessly selling a lot more harmful stuff to everyone including us. We should focus on that, rather than just be trapped in our own world of medicine and to cut communications inside it.
 
Senator Grassley and gang; Read it, print it, frame it, and hang it up on your office walls.
 
To learn more about the indispensable role industry plays in CME, read our paper on the topic here.

According to SCRIP Pharmaceutical News, Great Britain, once a popular destination for European Union parallel traded drugs – is fast becoming a major EU source country, leading to shortages of some major drugs there.

Last year, the British Association of Pharmaceutical Wholesalers (BAPW) warned about a risk of severe drug shortages over the winter as wholesalers ran down stocks in advance of price cuts on January 1st, 2009. It also noted that the problem could be made worse by parallel trading from the
UK caused by the weakness of sterling against the euro and other currencies.

In July this year, the problem of shortages was raised again, with claims that they were being caused by changes in
UK supply arrangements (many manufacturers had adopted the direct-to-pharmacy model), and that parallel exports could also be a contributing factor.

While it is wholesalers that are responsible for most parallel trade, it appears that in the
UK many pharmacies and even some doctors are plying their own mini-trade too. The ABPI says that the pricing discrepancies and the exchange rate factor have "created a financial incentive for either wholesalers, pharmacies or dispensing doctors to order extra medicines and sell them overseas for a quick profit.”

The industry is not alone in drawing attention to this situation.
UK health authorities and pharmacy bodies have issued strong warnings to the effect that pharmacists indulging in this kind of trade are acting "unethically,” particularly given the disruption the pandemic could cause in the coming flu season.

Keith Ridge, chief pharmaceutical officer at the Department of Health (DH), has written to NHS chief pharmacists noting that some NHS hospitals are "considering entering into agreements to export, or result in the export of, medicines for short-term financial gain". This, says Mr Ridge, is "wholly unacceptable" and "contrary to acceptable professional behaviour". Pharmacists who enter into such agreements at a time of pandemic "are acting particularly irresponsibly.”

So, if you think Her Majesty’s Government is going to sit passively by while American politicos ponder drug importation from their island kingdom – think again.

Yahoo? Yikes!

  • 08.27.2009

According to a report in PharmaTimes:

“A study has found that over 80% of on-line advertisements for Internet pharmacies accepted by the search engine Yahoo were in violation of US federal and state laws.The researchers were able to buy prescription drugs without a prescription from Yahoo Internet pharmacy advertisements, and in one case the drugs were imported from India, which is prohibited by US law, says the survey, which was conducted by research firms LegitScript.com and KnujOn.com.”

Moreover, the researchers acquired prescription drugs without a prescription from an Internet pharmacy approved by PharmacyChecker – the service by which Yahoo, Google and Microsoft require their Internet pharmacy advertisers to be verified as legitimate - and listed on PharmacyChecker.com. Those drugs were also imported from India."

Yahoo's policy requires Internet pharmacy advertisers to be "based in" the USA or Canada. The report reviewed three Internet pharmacies that were approved as advertisers based on having a Canadian pharmacy license but, in all three cases, the pharmacies indicated that the drugs would actually be shipped from locations including India, Singapore or Barbados, and not Canada. Moreover, one advertiser approved as a licensed Canadian Internet pharmacy said it could fill prescriptions anywhere in the world except for Canada, because prescription drug importation is illegal there, the researchers report.”

The complete report can be found here.

Earlier this week I discussed why differences in definitions of live and still birth make comparisons of international statistics on infant mortality misleading. But these divergences in reporting requirements are not the only reason that international comparisons of morality rates are unreliable and inaccurate.

In other cases, bureaucracy intrudes so that even those who meet the definition of live birth may not end up in statistics. In France, in order for the baby to be given a birth certificate as a live birth, one must have “a medical certificate [that] attests that the child was born ‘alive and viable’.” On the other hand, “[i]n the absence of a medical certificate attesting that the child was born ‘alive and viable,’ the civil service officer only establishes a certificate of a child without life,” in lieu of a birth certificate. Overall, “this procedure applies, on one hand, to children born alive but not viable, and on the other, to children stillborn after a term of 22 weeks…or with a weight of at least 500 grams.” Thus, there is ample opportunity for babies to not be counted either because they are considered nonviable or because a certificate that they were born alive and viable could not be obtained. The scale of the resulting impact on mortality rates is implied by statistics that show that under a sixth of recorded infant deaths in France take place in the initial twenty-four hours after birth, versus one-third in both the US and Canada.

Another such case is Canada. Like that US, Canada uses the WHO definition of live birth but bureaucratic complexities may mean that not every baby born alive makes it into the register of live births. One such baby is Sonja Stefnovic, born January 6, 2006 in Ontario and who, though she lived a mere 35 minutes, more than met the criteria for a live birth. Yet, when her parents asked for a birth certificate they were told none existed. The paperwork had been filed to register her death but not her birth, which, unbeknownst to her parents, had to been registered separately. As far as Ontario was concerned, Sonja had never been alive at all.

While such cases are unusual in most of Canada, they are endemic in Ontario where in the last ten years there have been over 30,000 cases of unreported births due to bureaucratic delays, confusing procedures, and a substantial fee for registering births. That adds up to thousands of missing birth records each year and constitutes 30 percent of records of babies who lived less than a year. And Ontario makes up 40 percent of births in Canada. Ontario has also consistently been late in reporting births to federal statisticians. Arne Ohlsson, director of evidence-based neonatal care and outcomes research at the University of Toronto has said that, "[b]ecause such a large proportion of the population is born in Ontario and those vital statistics are not accurate, the country's statistics are not accurate and comparisons with other countries will be inaccurate." Whether the flawed records are used in calculating national statistics or whether Ontario is omitted, the result is nonetheless a number that does not cover all the babies born in the country.

Even if you can overcome the statistical problems, there are other factors that make infant mortality rates an inaccurate tool for comparing the quality of care in different health systems. Access to and quality of care are certainly influential in determining death rates but elements related only partially, tangentially, or not at all to the medical system are critical as well. Many are cultural, like delayed childbearing, use of fertility treatment, multiple births, or a high percentage of teen births, since these trends come with higher prematurity rates. Further, mortality rates are affected by ethnic factors that differ widely –and cannot be dismissed merely as reflections of access or socio-economics.

Culture may also trickle into medical care in another realm, in influencing the willingness of doctors and hospitals to pull out all the stops to try to save even the smallest and most premature babies. In the US, the expectation is that doctors will do everything possible to keep preemies alive unless the parents object. But in the Netherlands, premature babies below 25 weeks gestation are no longer to be resuscitated because the chance of survival without serious disabilities is considered low and they are instead given palliative treatment. Other nations fall somewhere in between and in countries like the UK and Canada, the enormous cost of intensive intervention and shortages of pediatric nurses and spaces in NICUs have played a significant role in the debate over when and how to intervene.

What the ‘correct’ policy may be is beyond the scope of my present post –and the answer is probably neither singular nor fixed. But it is something that needs to be taken into account when comparing statistics.

All of these issue show why international statistics should be interpreted with extreme caution, at least until we know where the number come from, how they are derived, and what other factors are simultaneously in play. And although it may be frustrating to know that, as in this case, the answer may be that the statistics cannot tell us much about the strengths and weaknesses of health care systems and their relation to one another, it is better to know we are in the dark than to clutch at false illumination.



With all the talk about healthcare reform going around Washington, one thing that has been overlooked is an industry in which tens of billions of dollars is spent annually with relatively limited federal oversight—namely dietary supplements, or "complimentary medicine." The passage of the Dietary Supplement Health and Education Act (DSHEA), in 1994, represented an attempt by Congress to regulate the burgeoning marketplace in "natural" health remedies. The intent was to protect consumers from snake-oil salesman while allowing access to a large and legitimate category of health options. The most important reform in DSHEA established that dietary supplements would be regulated as foods rather than medicines. For that reason alone, it's time to review the shortcomings of DSHEA.

Are these products foods or medicines? Well, to quote the great Hoosier poet James Whitcomb Riley, "If it walks like a duck and swims like a duck and quacks like a duck, I call that bird a duck."

To those who would peddle dietary supplements as medicine, the message must be that FDA has the authority to stop you if and when you cross the line. And to Congress, the message is that if FDA is to embrace a "safety first" philosophy, then DSHEA needs to be reformed—because the line has been crossed too many times. This oversight must be corrected immediately.

For the rest of the story, check out this piece from Pharmaceutical Executive Magazine.

Ted Kennedy

  • 08.26.2009
Senator Kennedy passed away a bit after midnight today.  He lived 15 months after being treated for an advanced form of brain cancer.    To the end he fought for what he believed in and was warmly regarded by everyone he dealt with of both parties -- staff included -- for his kindness, trustworthiness and comraderie.   He was instrumental in reshaping FDA reform bills to refocus them on modernization not mindless retribution and it is unfortunate that illness left him unable to be fully engaged in the current health care debate.   I will let others reflect on the other apsects of his life and legacy.  As for me, I remember his moment of grace when delivering the eulogy for his brother Robert Kennedy:

"My brother need not be idealized, or enlarged in death beyond what he was in life; to be remembered simply as a good and decent man, who saw wrong and tried to right it, saw suffering and tried to heal it, saw war and tried to stop it.

Those of us who loved him and who take him to his rest today, pray that what he was to us and what he wished for others will some day come to pass for all the world."

As he said many times, in many parts of this nation, to those he touched and who sought to touch him:

"Some men see things as they are and say why. I dream things that never were and say why not."

 


There are few people who purport to be academics with a more apt name than Donald Light...  The man who invents statistics about international drug pricing and the cost of drugs and has no economics background is at it again and this time his ideologically driven and sloppy research finds a welcome home at Health Affairs. 

Light has a personal vendetta against Joe DiMasi of the Tufts University Center for the Study of Drug Development.    Light believes there is an international conspiracy to protect the validity of DiMasi's scholarly work on the cost of drug development.  Light thinks that because the data on actual costs for each drug studied is not publicly available it can't be verified which is like you can't trust audited financial statements unless you have all the taxi receipts publicly available.  The fact is, DiMasi's estimate of the capitalized costs of bring a new molecular entity to market, as opposed to just adding a liquid form of the same drug, has been verified time and again by analysis of private, public and public-private drug development activities where both opportunity costs and clinical trial complexity can be measured. 

But Light has his followers who are innovation haters and who believe that the true measure of drug costs are what it costs to bring a generic drug to market.    Which begs the question that his Lightness never answers:  if it costs so little to bring a new drug to market, why aren't generic companies innovators...

In his lightweight Health Affairs piece, Light only avoids the issue further by claiming that producing more pill forms in response to price controls is a true measure of innovation.   But he does a service by showing us the sort of dumbed-down health care we would receive under price controls of any form...and demonstrates again why Joe DiMasi is a class act and a real economist and some people just aren't either...

Oh, and Light has NO degree in psychiatry or medicine ...

Europe Has Expanded Its Lead Over The United States In Pharmaceutical Research Productivity

Separately, Researchers Find That Intellectual Property Rules Are Restricting Access To Generic Drugs In Guatemala; Third Study Encourages Participation Of Outside Experts In Pharmaceutical Patent Reviews In Developing Countries

Bethesda, MD -- It is widely believed that the United States has eclipsed Europe in pharmaceutical research productivity. However, a comprehensive data set of all new chemical entities approved between 1982 and 2003 shows that the U.S. never overtook Europe in research productivity, and in fact Europe is pulling further ahead, according to a study published today on the Health Affairs Web site. http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w969

The study is one of three released by Health Affairs dealing with prescription drugs and intellectual property.

http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w948/DC2

The U.S. share of approved new drugs did increase in the decade from 1993 to 2003, as compared to the previous decade from 1982 to 1992, but that simply reflected the fact that the pharmaceutical industry poured more of its research dollars into American labs, says study author Donald Light, a professor of psychiatry at the University of Medicine and Dentistry of New Jersey and the Lokey visiting professor at Stanford. Over both decades, the U.S. share of approved new drugs lagged behind its share of research funding.

On a dollar-for-dollar basis, Europe was more productive in discovering new drugs than the U.S. was, and the European productivity advantage was greater in the period from 1993 to 2003 than it had been in the period from 1982 to 1992. Japan outstripped both Europe and the United States in pharmaceutical research productivity over these twenty years.

“Congressional leaders and others concerned about high prices of new patented drugs will be heartened by this analysis, because lower European prices seem to be no deterrent to strong research productivity,” writes Light. He cites previous research showing that pharmaceutical companies are able to recover research costs and make a “good profit” at European prices, and he rejects the notion that Europeans are “free-riding” on American pharmaceutical research investments.

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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