Wide Awake

07/10/2007 11:24 AM |

I wanted to call attention to my recent piece in the Florida Sun-Sentinel about insomnia, and its related health issues. The piece centers on the recent excellent Alan Berliner documentary Wide Awake on HBO.
I am what i would call a self-induced insomniac, i use it to get my writing done and meet deadlines. Unfortunately, this establishes a pattern of middle of the night wakefulness which persists even when i have no deadline. This is not good for my health. I don't currently take sleeping pills, but many of my patients find them useful - and in fact Ambien is one of those examples of good drugs that to from panacea to panic whenevever a media report focuses on the rare sleepwalker. All drugs should be managed or monitored by the doctors who prescribe them, but they are not good guys or bad guys, they are useful arrows in our medical quiver.

http://www.sun-sentinel.com/news/opinion/sfl-forum06insomnianbjul06,0,5107682.story?coll=sfla-news-opinion  Read More & Comment...

The Whack Pack's Attack on Medical Progress

07/09/2007 10:13 PM |

The Journal of Life Science provides a great weekly brief of health care and medical innovation news and opinion. This week is no different.

http://www.tjols.com/wb/07jul06.html#diabetes

What I find striking is that so many of the incremental advances in medicine -- those that will lead to more predictive and preventive care -- will depend on future investment to both test the validity and reliability of new information as real products. To quote Robert Solow many if not most innovations need to be embodied in new kinds of ..... equipment before they can be made effective. Improvements in technology affect output only to the extent that they are carried into practice either by net capital formation or by the replacement of old-fashioned equipment by the latest models…”

Of course, that process of commercialization requires profit, risk taking, marketing, industrial-academic relationships, patent protection. In short, everything need to make this world a better place through technological advancement most of what I will call the Whack Pack either opposes, makes money critcizing or suing.

Now nothing's perfect and change is constant. Compassion, trust and honesty should inform all social relations. But to suggest ridding science of commercialism will bring about a better and brave new world is...in a word, whacky and dangerous.  Read More & Comment...

"Where are all the dead Canadians?"

07/09/2007 09:55 AM |

That oft repeated question by the proponents of drug importation. Sadly, today's answer is, in Vancouver.

Here's the news from Canada's newspaper of record, the Toronto Globe & Mail.

ONLINE PHARMACIES

Counterfeit drugs caused woman's death, coroner concludes
ARMINA LIGAYA

July 6, 2007

VANCOUVER -- Shoddy pills from a bogus online pharmacy are to blame for the death of a 58-year-old woman from Vancouver Island, a coroner's report says.

Yesterday's conclusion makes Marcia Bergeron the first clear-cut case of a death stemming from counterfeit drugs bought on the Internet, but it likely won't be the last, said Rose Stanton, regional coroner for Vancouver Island.

"The quantity of seized counterfeit medication is huge," she said. "And so, what we have is the first person [for whom] we have all the facts, who we know died as a result of these drugs.

"But what we also know is lots of people are buying these drugs. So the potential for more deaths is high."

Ms. Bergeron was found by a friend on Dec. 28, 2006, in her bed in a normal sleeping position. Emergency services were called, but it was clear she had been dead for some time.

Three types of pills were found at Ms. Bergeron's home. One contained Zolpidem, a powerful hypnotic not available in Canada. Another contained the anti-anxiety medication Alprazolam, which is available with a prescription, and the third contained acetaminophen.

These drugs were later determined to be laced with extremely high quantities of metal. The acetaminophen pill had 15 times the amount of aluminum that would be fatal, Ms. Stanton said.

An autopsy showed that Ms. Bergeron died of cardiac arrhythmia stemming from metal toxicity.

In the weeks and months leading up to her death, she complained of flu-like symptoms. Ms. Bergeron said, in e-mails to a friend, that her hair was falling out, and she suffered from nausea, diarrhea, aching joints and blurry vision.

When the pills were tested, they were of such poor quality, the ingredients seemed "mashed together" Ms. Stanton said. The mixture of drugs and metal in each pill would vary depending on which portion was examined, she said.

The metal contaminants were likely part of the filler materials used to make the pills, the coroner's report said.

On Ms. Bergeron's computer, records showed she had been visiting websites from which medication could be purchased.

When U.S. Food and Drug Administration investigators examined her hard drive, it showed Ms. Bergeron bought Zolpidem - a powerful sedative available by prescription in the U.S. but not in Canada.

The website she used, which purported to be Canadian but has since gone offline, was previously flagged by the FDA concerning counterfeit Zolpidem.

Because of all these elements - computer records, e-mails, drugs found on scene and a subsequent autopsy - investigators were able to definitively link the online drugs to Ms. Bergeron's death.

It's an FDA first, Ms. Stanton said.

She said the website Ms. Bergeron used is one of thousands that claim to be reputable pharmacies.

"The site that she purchased from is one of a group of sites that the FDA says use the tactic of phoning people after they get the first order," she said. "They phone for the renewal so there isn't a computer record."

Marnie Mitchell, CEO of the B.C. Pharmacy Association said that Canada has a very regulated and monitored pharmacy system, and stepping away from it has risks.

"Online sources are very difficult to assess their legitimacy and their safety," she said. "This is a very tragic episode and illustration of the problems that stem from going to those kinds of places."

Cracking down on these websites, however, would be a difficult endeavour, she said, because they change and shift very quickly and are hard to trace.

Instead, she recommended the federal government launch a public-awareness campaign to warn people of the potential dangers.

Alain Desroches, spokesperson for Health Canada said the agency regularly flags counterfeit products and issues public advisories. It also works with RCMP in investigating counterfeit drugs. However, he could not comment on any policy changes that would stem from the coroner's findings.

"We welcome the report and it's going to be reviewed carefully," he said.  Read More & Comment...

MaLADE-O

07/09/2007 09:23 AM |

In today's New York Times, Paul Krugman calls for universal health care in the United States, calls those who oppose it all sorts of nasty names, and points to SiCKO as his proof of concept.

Note to Paul: Read the ads for SiCKO in your own paper -- it's billed as a comedy.

To get a feel for his general position, consider this statement, "Medicare ... is being undermined by privatization."

What he doesn't say is that ... it's working. Every poll shows that seniors are very pleased with the Part D benefit-- and by huge margins. And every government report shows that the program is coming in significantly below cost projections.

Imagine that, a government program that people like and comes in under budget. Privatization may seem like a frightening concept to Mr. Krugman, but it sure works.

But why let facts get in the way when you've got an agenda to pursue?

And here's the agenda, summed up in one sentence:

"Universal health care would save thousands of American lives each year, while actually saving money."

Really? All the statistics from Europe and other nations with government-run health care say different. Having just returned from a conference of European health care experts, regulatory officials, and legislators, I can attest to the many problems European government are facing as they try to reinvent their own national systems for the 21st Century.

Paul -- come with me to Europe and let's film a documentary of not only care denied but care unavailable. I'm sure we could make it as "entertaining" as SiCKO. It's easy to prove an argument when you cherry-pick the facts. We can call our movie "MaLADE-O."

Ooh-la-la!

Mark Twain wrote, "For every complex problem there is a simple solution -- and it is usually wrong."

Alas, there is no perfect, easy solution to the American health care miasma. That only happens in the movies.

For a more balanced view of how to advance the cause of health care in America, read what HHS Secretary Mike Leavitt has to say ...

http://www.washingtontimes.com/article/20070709/EDITORIAL/107090020/1013

And -- see you at the movies.  Read More & Comment...

Fear of Flossing

07/09/2007 07:42 AM |

Word on the Hill is that Rahm Emanuel is going to try to tag sound FDA reform legislation with an unsound amendment on -- yes, you guessed it -- drug importation. Is anyone out there shocked? Probably not. After all, for Mr. Emanuel politics is more important than the public health.

Here's a new Chicago Tribune op-ed on why drug importation is a bad idea:

http://www.chicagotribune.com/news/opinion/chi-oped0708taintjul08,0,1697228.story?coll=chi-newsopinioncommentary-hed

You can't be for drug safety one day and against it the next. You can't rant against counterfeit tainted toothpaste and embrace the importation of foreign drugs. It's intellectually dishonest and contrary to the best interests of the public health.  Read More & Comment...

my July Antidote column in M,M, &M on avandia

07/08/2007 02:16 PM |

When Rezulin was removed from the market several years ago, the top endocrinologist I worked with was quite upset. Of course he knew about the few cases of severe liver failure and the rare death, but he also knew how many patients benefited directly from the drug. "Avandia will be next," he predicted.
Thiazolidinediones (TZDs) are a class of drugs which improve insulin receptor sensitivity and reverse the insulin resistance typically seen in type 2 diabetes. Since most type 2 diabetics have too few receptors per body surface area, the TZDs are very useful drugs.
The fact that patients ont he remaining two TZDs (Avandia and Actos) can gain weight on these drugs is not news. The question of whether they can cause or worsen heart failure has long been discussed. Unfortunately the current raging debate and targeting of the FDA and the drug manufacturers doesn't directly address this question. The existing information is based on mathematical analyses of previously published data and is weak.
Prospective randomized trials are necessary, but what should a clinician do? All too often, as the pendulum swings from panacea to panic, a perfectly good medication has its reputation damaged or destroyed based on limited or overblown results, all in the name of drug safety.
To give just one example as it relates to TZDs, it is clear that controlling blood sugar is important in preventing diabetic end organ damage. Among these crucial organs we try to protect is the heart. Everyone agrees that Avandia and Actos help to significantly lower blood sugar. But as their reputations are damaged in the media, how many safety-driven zealots have stopped to consider what uncontrolled sugars mean to the heart? Now that patients - and doctors - will be running from these drugs with their new "black box" warnings, what will be the clinical results? In other words, which will cause more heart damage; the drugs themselves, or stopping them?  Read More & Comment...

An Inconvenient Truth: Kids and Counterfeit Meds

07/06/2007 10:57 AM |

If you think it's easy for Al Gore III to score Vicodin and Aderall without a prescription, ask Zach Goldberg (aka his dad) just how quick and convenient it is to buy roids, Vicodin, ritalin, etc. online using his age (19) or any age for that matter. I did it, no problem using two different credit cards.

http://news.yahoo.com/s/ap/20070706/ap_on_he_me/gore_s_son_drugs;_ylt=AjKNKTx3L_N9zjupcFNwSgER.3QA

Note to Rahm Emanuel: Most fake drugs will come through the Web. They will be bought by kids who will use them recreationally or to resell them. Organized crime will profit and kids will suffer.

At what point will your concern for the welfare of kids overtake your politically motivated hatred of drug companies?  Read More & Comment...

If iPhones Were Pharmaceuticals

07/06/2007 08:00 AM |

From the American Spectator:

If iPhones Were Pharmaceuticals

Prescription drugs cost too much! Or at least that's what we hear, day-in and day-out, on television, in the news, and, of course, in Sicko.

Some health-care activists have rallied around high drug costs to agitate for more government regulation of the pharmaceutical industry and more government involvement in health care. Hoping to stoke public anxiety over prescription bills, these activists often point to "cheaper" foreign drug prices to garner support.

Fortunately, prescription drug price controls aren't coming to the United States. But now activists have turned to a new tactic: proposing to force American drug companies to sell their wares to foreign governments at whatever price and in whatever amounts those governments demand. American companies would also be unable to contractually bar those drugs from being imported back to the U.S. -- leading, in essence, to the imposition of foreign price controls and all their attendant safety complications.

Needless to say, this idea -- that the government should require an American industry to play cowering "yes-man" before the whims of foreign nations -- would be devastating to any of America's top industries. Imagine if a different sector of the economy -- say, a high-tech firm like Apple -- had to cope with such constraints.

Apple might schedule a meeting with a foreign distributor, but instead of haggling over bulk discounts and special deals on excess pink iPods, its representatives would find the terms of the sale already structured. The foreign buyer would be able to name its price and quantity, and it would demand permission to resell everything it purchases back to U.S. consumers.

In the background, the U.S. government would nod approvingly.

In other words, what used to be a process of negotiation would instead be a process of submission. Apple would have no way to protect its product or its revenues. It would certainly end up in deals that it would otherwise never agree to. And investment into the next generation of iPods, iPhones, and other products would decline.

Apple's domestic operations would suffer, too. Having just gotten a steal of a deal from Apple, the foreign distributors would be able to undersell domestic firms in the U.S. by reselling Apple products at a significant mark-up. Who benefits? The middlemen, of course. Consumers would only see a tiny price break and Apple and its domestic distributors would see a nosedive in sales. This isn't an example of market forces at work; it's the unfair exploitation of domestic firms.

Initially, Apple might find a way to adjust to forced sale. But in losing control over the terms of sale and distribution of its products, it's almost a certainty that the company's bottom line would take a massive hit.

In response to the loss in revenue, budgets would be slashed, with research and development into new products an early casualty. And with the threat of price controls destroying the prospect of new financial success, the next product would take longer to get to market and be far less innovative. Developing the next big computing device is a costly, time-intensive, and risky undertaking, so the stakes for a successful new product would be much higher.

With no margin for error, following up the iPod with the commercial equivalent of Betamax could be fatal. And that death would stand out as a blow not only to the American computing industry, but to broader American economic competitiveness as well.

Apple and the rest of the American high-tech industry may not have to worry about foreign governments dictating the prices they may charge while the U.S. government looks on approvingly. But advocates of forced sale are pushing for precisely this kind of absurd policy on pharmaceutical companies. The class of good may be different, but the effect is the same -- financial disaster and reduced innovation.

In fact, because drugs save our lives rather than simply entertain us, such stifling of the next round of research may be fatal not only to pharmaceutical companies, but to us as well.

Instituting a forced sale policy on any other industry would result in a great deal of outrage. It's high time that we treat such dressed up price controls on pharmaceuticals with similar looks of consternation.

Peter J. Pitts is President of the Center for Medicine in the Public Interest and a former Associate Commissioner of the FDA.   Read More & Comment...

Patients first please, we're British

07/05/2007 09:17 AM |

According to Reuters, British drugmakers are launching a legal challenge to moves by the state-run National Health Service to switch large numbers of patients onto cheap generic prescription medicines.

The Association of the British Pharmaceutical Industry (ABPI) believes such schemes are potentially unsafe and primary care doctors are receiving additional payments to prescribe certain low-cost medicines in contravention of European law.

ABPI argues patients should have to give explicit consent for any switching rather than leaving them to object if they wish to do so.

A Department of Health spokesman said the government would rigorously defend the legal challenge.

We here at Drugwonks don't believe that doctors should be paid to prescribe anything. Their only incentive should be to do what's best for their patients. And that goes for any innovator company that would do the same thing for on-patent medicines.

But, somehow, when governments practice cost-based rather than patient-centric medicine they are called "good stewards." That's absurd -- and dangerous.

For an eloquent example of one doctor's frustration with the escalating generic switcheroo, please see CMPI senior fellow Dr. Marc Siegel's article, "The Unreal World." Here's a link:

http://cmpi.org/archives/2007/06/the_unreal_world.php

At a time when we are debating the issue of biosimilar interchangability, let's not forget to keep our eye on what's best for the patient, not what's cheapest for any given payor.  Read More & Comment...

PDUFA. Pulp Fiction?

07/05/2007 08:38 AM |

Balanced reporting or slanted coverage -- you be the judge.

Here are first three paragraphs from a story in today's Washington Post on PDUFA reauthorization:

"Three drugs -- Vioxx, Ketek and Avandia -- are casting long shadows over the congressional debate on how to update and revise the 15-year-old system that has dramatically sped up the process of bringing prescription medicines to American consumers.

All three ran into problems after the Food and Drug Administration approved them for use. The problems ranged from thousands of heart attacks partly attributable to the painkiller Vioxx to a few cases of liver failure caused by the antibiotic Ketek. And the hazards of the diabetes drug Avandia are only now emerging.

Together, the three drugs epitomize what can happen when a new pharmaceutical moves from the small and orderly world of scientific testing to the big and messy world of everyday use. Many experts now hope that efforts to do a better job of identifying the "unexpected toxicities" in drugs that have reached medicine cabinets will get a boost from an unexpected source -- the Prescription Drug User Fee Act."

Long shadows? The choice of phraseology certainly leads the reader in one direction. My favorite is when PDUFA is referred to as an "awkward acronym." As opposed to what, an elegant acronym? We all know that newspaper circulation is down, but does that explain why articles on serious subjects such as FDA reform should start sounding like dialouge from a Quentin Tarentino movie?

Here's a link to the entire article:

http://www.washingtonpost.com/wp-dyn/content/article/2007/07/04/AR20070704017.html

Let's get this guy a thesaurus and a better editor.  Read More & Comment...

Danny Carlat Inc.

07/04/2007 12:20 PM |

It is July 4th and am surfing the web to see what our freedoms hath wrought...

Danny Carlat, the self-styled independent shrink has a blog that lumps drugwonks into the pro pharma group and then has another grouping dubbed "Great Pharma Information."
http://www.carlatpsychiatryblogspot.com

Included are the whack jobs over at the Alliance for Human Research Protection who pushed the SSRI-suicide connection and was founded by Loren Mosher, who believed that manic depression has no biological basis. http://www.ahrp.org

Great pharma information?

And we also have the Prescription Access Litigation Project. That is a labor/Public Citizen/PIRG dragnet for lawsuits against drug companies that -- in combination with Trial Laywers, Inc. -- split the profits of settlements. No financial interest there of course. One of the law firms that is quarterbacking the PAL litigation is Hagens Berman Sobol and Shapiro which is famous for suing Apple for designing the Ipod for playing music too loud through earphones and possible causing deafness. (Volume conrtrol anyone?) Berman Sobol is also "investigating" Glaxo...as in: If you, or someone you love, took Avandia and suffered a heart attack or heart related death you may want to contact one of our attorneys in order to determine if your are entitled to compensation for your injuries. Please e-mail HBSS at info@hbsslaw.com or call 206-623-7292."

Great Pharma info indeed. Let Carlat ally himself with anti-science extremists and tort lawyers. In the wake of the SSRI-suicide debacle I will put my trust in the so-called pharma-academic complex any day..... Commercialization, carefully constructed and considered -- is the key to medical progress. The notion that purging capitalism from medical research will produce better medicine is not only a hypothesis that has been tested and rejected, it is dangerous.

Let freedom ring!  Read More & Comment...

Scared To Death

07/03/2007 03:23 PM |

While we are on the subject of the Fear Factory (leftist academics, medical journals and journalists) the grudging coverage of the safety of anti-depressants and their value in reducing suicide should be noted. Last week it was the NEJM deciding to publish slowly and silently a study that pregnant women could use antidepressants will little risk to their infants and a media that barely reported the results. This week it was yet another large and careful observational study -- this time by Greg Simon from Group Heath of Puget Sound -- showing that far from causing suicide, antidepressants actually reduce the risk thereof.

Setting aside the abject coverage of these important studies, the attack on the safety of SSRIs needs to be re-examined from top to bottom. We have been told that for marketing purposes companies have buried the real dangers of drugs, that direct to consumer advertising pushes people to take medicines that they do not need but are unsafe, that industry sponsored research and medical conferences are corrupting and not informative.

But now the results of following the purists are clear. We did follow the sage counsel of the Jerry Avorns, Sid Wolfes, Marcia Angells, David Healys and Jerome Kassirers of the world. We ignored the studies showing clinical benefit of SSRIs and embraced their distrustful view of medicine which was based not on science but on the belief thata because drug companies are commercial enterprises neither their products or information cannot be trusted and that any relationship they enter into corrupts those who engage in them.

We have seen the results with SSRIs. The blog PurePedantry does an excellent job of laying out the human consequences of following a medical regimen “free” of industry involvement. They cite another article in the American Journal of Psychiatry that looked at the trends in the number of kids getting SSRIs in the wake of creating an industry free zone: A more sobering perspective on these data gives cause for concern.

An article -- also in the American Journal of Psychiatry - traced what happened to prescribing of SSRIs after the fear mongering and linked it to suicide rates:

"Pharmacoepidemiological studies examining the relationship between trends in sales or prescription fills of SSRIs have consistently shown a relationship between increases in SSRI prescription rates and declines in adolescent suicide rates. On the basis of those studies, one might expect that the adolescent suicide rate would begin increasing in the wake of the FDA advisory after a decade of steady decline."




Less marketing, less detailing, less CME. More regulation and warnings. But the void is filled by self promoting quacks like Gary Null, Scientology fronts, trial lawyers, and angry critics who use anecdotal material to rant about corporate influence. And the result? Fewer patients and more death. It happened with depression and it is happening with schizophrenia and manic depression. We need more corporate involvement, not less, to advance the public health and save lives.

http://scienceblogs.com/purepedantry/2007/07/the_fda_warning_on_antidepress.php






  Read More & Comment...

Statins Cause ALS? Fat Chance

07/03/2007 02:55 PM |

The article today in the WSJ about a “link” between ALS and statin drugs underscores how much of epidemiology is nothing but statistical self-gratification that has grown exponentially in the hopes of seducing self-important medical journals who in turn seek to whet the appetite of journalists looking for peril in every pill.

The ALS-statin connection could have been addressed easily by asking if there was an overall increase in the incidence or prevalence in ALS since the widespread use of statin drugs beginning in the 1980s, particularly among the elderly. There are careful registry data in virtually every Western country in the world on ALS patients, some dating back to the 1920s that capture every new case of ALS and measure against increases in total populations and various demographic characteristics.

ALS incidence and prevalence is virtually unchanged since the beginning of the century. So if statins have a direct causative effect it would have shown up by now. Why no one, let alone the author of the WSJ article did not ask this simple question is beyond me.

Now more interesting is the fact that Beatrice Golomb, who is studying the evil effects of statins, claims to have found a link between low cholesterol levels and violence Indeed, there are a handful of articles that claim to have seen this association after doing some data dredging. (Uh, maybe they should control for age since most crime is committed by young people and most young people have...low cholesterol, duh.) And they NIH is giving her money?

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=11104842&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstractPlus



I can’t wait to the lawsuits flying around the claims that statins cause violent behavior. They WILL come.

Meanwhile, shame on WSJ's Jacob Goldstein and WHO's Ralph Edwards for even proposing that this is anything more than a coincidence. You give me four million data points and I will show you that there is a relationship between Jacob Goldstein and half the pregancies in Passaic, NJ.

http://blogs.wsj.com/health/2007/07/03/data-crunching-hints-at-risk-of-cholesterol-drugs/  Read More & Comment...

NASTY or NICE?

07/03/2007 08:42 AM |

NICE = the National Institute for Clinical Excellence -- the United Kingdom's center for deciding which medicines will be reimbursed. But more and more Britains are calling it by another, more descriptive acronym -- NASTY: Not Available So Treat Yourself.

To that end, allow us to recommend a new op-ed in the Journal of Life Sciences, "Strange Bedfellows."

Here's a taste:

"The politics of healthcare make strange bedfellows. Nearly 15 years ago, most health insurance plans opposed Hillary Clinton when she tried to give American healthcare a makeover in the image of the European and Canadian system. Back then, insurers blasted the Clinton plan as government takeover of medical decision-making based on cost considerations.

Last month, the presidential hopeful and the insurers stood shoulder-to-shoulder in support of giving the federal government the same power government agencies in single-payer systems have to determine what new medicines and services to pay for or not, based on what a government agency decides are cost-effective. In essence, both Clinton and the health care lobby want the government to engage in the practice of medicine.

What's changed? Clinton has always regarded government as the best arbiter of value for medicine. Health plans, now that they have a stake in Medicare, want the government to make across-the-board decisions about reimbursement. Now the Medicare Payment Advisory Commission, the independent federal body established to advise Congress on issues affecting Medicare, has endorsed a specific approach. It wants an independent entity to sponsor credible research on comparative effectiveness of health care services and disseminate this information to patients, providers and public and private payers.

The model, believe it or not, is Britain's National Institute for Clinical Excellence, which reviews comparative effectiveness of new and often expensive medicines in the way the Medicare Payment Advisory Commission and Senator Clinton envision. Steven Pearson, a senior fellow with the insurance industry lobbying group America's Health Insurance Plans, thinks that the British approach is an example of leadership and courage. As such, it's worth looking at the decision process our nation should follow in deciding how, whether and in what circumstances it will pay for a medicine."

Here's a link to the entire article:

http://cmpi.org/archives/2007/07/strange_bedfellows.php

And for those of you who like to read ahead, here's the article's concluding paragraph:

"Personalized medicine gives doctors and patients control over healthcare decisions while comparative effectiveness, as it is now defined, will increase government control over the choices doctors and patients make in the future. The battle over the value of medicine and who decides what is valuable will determine who controls healthcare in America over the next decade. That explains why Clinton and the insurance lobby are allies in the effort to give government more control over these important choices in the years ahead."  Read More & Comment...

When the All Saints Come Marching In

07/03/2007 08:08 AM |

You cannot escape the responsibility of tomorrow by evading it today.

-- Abraham Lincoln

When the government issues health care statistics there are usually two general responses from the constituencies that are influenced – “this shows a problem,” or “the study is flawed.” And what ensues is a blame game, a political, polemical battle of op-eds and spin. What rarely happens is that all sides consider the implications of the numbers and use them to advance the public health. There are many examples of this, perhaps the best known being the debate over the Part D drug benefit.

But a new study, just released by the Center for Medicare and Medicaid Services (CMS), is breaking the mold. And it’s about time. The report, based data on Medicare patients who died from heart failure between July 2005 and June 2006, ranks hospitals as to whether they fall above or below the average and the results are available and searchable on a federal Web site (www.hospitalcompare.hhs.gov) that compares mortality rates among the nation's more than 4,000 medical facilities.

Needless to say, those scoring well crowed and those falling below the national average started the spin cycle. Examples were not hard to find – that’s not news. What is important to discuss, on the other hand, is how some hospitals dealt with their below-average ranking. As I searched through the CMS database, I was surprised to find Baylor All Saints Medical Centers at Fort Worth Texas on the “below average” side. Having followed Baylor Health Care System over the years for a variety of reasons, I decided to look a little closer.

Here's the rest of the story:

Download file

The take-away?

"... if we want people to take more responsibility for their own health – those in the business of health care must as well. Do as I say, not as I do just doesn’t cut it when it comes to advancing America’s health."

The price of greatness is responsibility.

-- Winston Churchill  Read More & Comment...

Here's a NHS Doc Sicko Missed

07/02/2007 06:00 PM |

Since Michael Moore regards Al Qaida as a bunch of freedom fighters this story from Britain's Daily Mail about the UK terrorists should make him and drugwonks "friends" in the blog world giddy with delight...

"Terror ringleader' is brilliant NHS doctor

An Iraqi junior doctor and a brilliant neurologist working for the NHS are among the suspects being quizzed over the series of bomb attacks across Britain, it emerged today."

And oh yes, there was a controlled explosion carried out at the Royal Alexandra Hospital.

Our prayers and thoughts are with the citizens of the UK.....

Read here
  Read More & Comment...

Is Your Reporter Tied To Bonuses?

07/02/2007 09:42 AM |

The NY Times has a editorial today supporting a government registry that would require drug companies to report all gifts it gives to doctors that might be construed as influencing their prescribing behavior. Here's the justification the Times editorial board gives for supporting this intrusion into the privacy of doctor's lives:

"As Gardiner Harris reported in The Times last week, one drug company invited doctors to a weekend training session in Orlando, Fla., to learn how to give marketing lectures to other doctors for an asthma medicine. The enticement was free airfare, a rental car and hotel room, plus a $2,700 stipend."

Enticement? How about covering travel expenses and professional time. As for the allegation that docs were "influenced". Where is the data and where is the evidence of patient harm.

Since Americans now get their information on health from major media outlets I would propose another registry: A list of all reporters who get bonuses for writing articles that "break" stories that affect people's perception of public health institutions or drug safety. It would be wrong, wrong, wrong for the New York Times or any paper to reward a reporter with a cash bonus for writing an article just because it caused a ruckus on public health matters, say for instance, an article about the financial ties of the advisory committees for the FDA. I mean a financial reward for an article on financial ties shaping decisions. I mean that would be so hypocritical as to be....ironic.

The Times should just clean it's own house or tend to it's own garden.

http://www.nytimes.com/2007/07/02/opinion/02mon2.html?_r=1&oref=slogin  Read More & Comment...

Early Reality Check on Comparative Effectiveness

07/02/2007 09:12 AM |

Here's MedPac's upbeat message on how evidence based medicine will revolutionize health care. It will lead to

"[increased] federal administrative spending relative to current law" due to "increasing the capacity to examine the comparative effectiveness of health care services," and "[improved] decision making by patients, providers, and payers" due to "information on the comparative effectiveness of health care services."

Cut to the Subcommittee on Health of the House Committee on Ways and Means hearing on developing a new reimbursement system for Erythropoiesis-stimulating Agents (ESAs), for a reality check. In particular, the statement of Alan S. Kliger, M.D., President, Renal Physicians Association, Rockville, Maryland on "Variability in ESRD Patient Hemoglobin Levels"

"Recent studies warn that kidney failure patients should not have high blood counts, noting that a group of patients with high blood counts in general carried a higher risk than patients with lower blood counts. But my experience with one of my patients shows how patient-centered care sometimes should deviate from guideline-advised care. I have a 52-year-old patient who is in kidney failure. When his blood count is less than 36 percent, he feels tired and washed out and experiences chest pain. When EPO raises his blood count to 38 percent, he feels like a healthy man; he functions better and feels more productive. The differences are so prominent to him that he tells me what his blood count is before I have a chance to measure it. For this particular patient, a higher blood count is what he needs in order to function normally. My patient knows that the recent studies warn about the long-term side effects of these higher blood counts, but he also knows he needs these levels to function normally. His choice and mine for enough EPO to maintain higher blood counts is the right choice.

RPA believes that in the recent discourse on national coverage of EPO, the critical issue of variability of individual patient response to EPO dose has been understated. As we have noted in correspondence to CMS, attempts to assess or quantify individual sensitivities (i.e. responsiveness) to EPO at a narrow level have not been successful.

Therefore, there is no single, predictable response to a given dose of EPO, a fact that accounts for the wide range in individual responses to treatment. As a result, in the aggregate it is physiologically not rational to tailor a normal distribution of patient responses to a payment limit: such a paradigm cannot be successful in delivering optimal treatment with sophisticated agents to complicated patients.


Payment limits structured in this fashion place emphasis on the wrong arm of therapy: emphasis should be placed rather on reducing the number of patients with low hematocrits/hemoglobins (<30%/10 gm/dL). "

http://waysandmeans.house.gov/hearings.asp?formmode=detail&hearing=573

MedPAC and the rest of the comparative effectiveness club are ignoring the human consequences of one size fits all decisions such as these or the denial of cancer and Alzheimer's care in the UK, Canada, Australia. The focus is on the structure of the center, the funding, furniture, color schemes, resumes, etc.

The comparative effectiveness movement will, like the Clinton health plan, be undone, by it's arrogance, high-handedness and contempt for the doctor-patient relationship.  Read More & Comment...

"Most Americans believe that ..."

07/02/2007 07:46 AM |

Does that headline look familiar? Of course, you see it all the time in headlines about "new poll findings." But, as any savvy drugwonk knows, you can get any answer you want depending on how you ask the question.

So we decided to see what some New Yorkers know -- or think they know -- about a couple of health care issues in our latest podcast.

Have a look:

http://cmpi.org/archives/2007/06/what_do_people_really_know_abo.php

If you have questions that you'd like us to ask in our next podcast, please send them along by commenting via this blog.  Read More & Comment...

Patent Farm: Chilling Innovation in the Great White North

06/29/2007 01:02 PM |

“All animals are equal, but some animals are more equal than others.” A famous line from a famous book with a famous lesson – they’re not.

Today that lesson needs to be relearned. Case-in-point, a Canadian judge’s apparent belief that all patents are equal, but some patents are less equal than others.

Specifically, pharmaceutical patents.

But first a point of order – this is not about the position of the Government of Canada, which is very good on these issues. This is about the actions of an activist judge – the Honourable Mr. Justice Hughes, of the Federal Court of Canada.

It’s about a patent case brought by Novopharm (the large Canadian generics company) against Eli Lilly (the large American pharmaceutical company). But the issue is considerably broader and the precedent is frightening not only for innovator pharmaceutical firms – but for the future of Canadian public health.

The issue, relative to a pharmaceutical patent, “… is the sufficiency of the disclosure in the patent itself…” Judge Hughes’ decision has created a requirement that “… the advantage must be plainly and fully set out in sufficient detail so as to enable a person skilled in the art to know and appreciate what they are.” That is, the judge found that it is “mere rhetoric” to only state the advantages of the invention in the patent specification.

And get this – Judge Hughes ruled on an argument that wasn’t even made by Novopharm. He invented and then ruled on his own argument.

Here's a link to Judge Hughes’ June 5, 2007 decision:

http://decisions.fct-cf.gc.ca/en/2007/2007fc596/2007fc596.html

(PS/ A Canadian appellate court chastised Judge Hughes' decision.)

A couple of crucial points:

Eli Lilly Canada Inc. v. Novopharm Limited raises a significant new question of law and represents a significant shift in the requirement for disclosure in patent applications that has an immediate impact on presently pending applications and patents-in-force in Canada.

Judge Hughes’ ruling is out of step with Canadian law; it violates international IP treaties (TRIPS, PCT), and makes Canada an outlier among all developed and developing countries.

For example, the Patent Cooperation Treaty (PCT) provides for the requirements of a patent specification and states that the “description shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art.” Considering that Canada is a member of the PCT, it seems that the Federal Court has now made Canada non-compliant with its treaty obligations.

Furthermore, by applying this “super-sufficiency” requirement to a certain class of improvement patents (so-called “selection” patents); the decision also violates the nondiscrimination clauses of TRIPS. TRIPS requires that the standards of patentability for all technology must be the same. In addition, by applying this requirement only to selection patents, the legal requirements in Canada now improperly establish a higher standard of patentability for this type of innovation in contravention of the non-discriminatory clauses of TRIPS.

And, even worse, the Court of Appeals in Canada has created a practice of dismissing any adverse ruling against the pharmaceutical patent as being moot if the generic obtains its marketing approval before the appeal can be heard. So, a generic challenger has their day in court and a full opportunity to appeal a ruling. The innovator pharmaceutical company has their day in court with the first challenger and if there is an adverse ruling will have no opportunity to appeal. To further exacerbate matters, the Court of Appeals has also held that once the first generic challenger has prevailed subsequent challengers should also be granted an approval.

So much for checks and balances.

These actions are manifestly unfair to the research-based pharmaceutical industry and will chill pharmaceutical innovation in the Great White North. This illegal and unfair attitude, if it continues unfettered or unquestioned, will lead to fewer innovative pharmaceutical products being made available to Canadians.

Ah, those pesky unintended consequences.  Read More & Comment...