SG as ASG

09/24/2007 07:29 AM |

Steve Galson is a man of honor, integrity, passion, and intelligence -- and he's a terrific choice for Acting U.S. Surgeon General.  Read More & Comment...

Yom Kippur

09/21/2007 08:15 AM |

Drugwonks will be closed and will not be updated until after Yom Kippur is over.. We leave you with a story that reflects the essence of Rabbi Israel Salanter, a leader of the Mussar (Orthodox Jewish values and ethics) movement in Vilna..

Two unforeseen developments rocked Reb Yisroel's stay in Vilna. The first was related to Reb Yisroel's attitude toward matters of health. He accepted doctor's orders as halachah (Torah law), implicit in the command of ''V'Nishmarsem M'od L'Nafshoseihem", "And you shall guard your lives" (Devarim 4:15). When health concerns conflicted with other halachos, he usually decided with a consistent leniency as far as the latter was concerned. He seemed to share Reb Chaim Brisker's view: "I am not lenient in regard to Shabbos or Yom Kippur; rather I am stringent in the laws of preservation of life!"15

Since Reb Yisroel never rendered any halachic decisions in Vilna, not even for his own household,16 he must have experienced enormous personal conflict during the peak of a cholera epidemic that devastated Vilna in late summer 1848. Reb Yisroel had committed himself to the city's welfare - renting hospital quarters with five hundred beds, while his own talmidim nursed the stricken around the clock, seven days a week, with patient care on Shabbos no different than on the other days of the week. As Yom Kippur approached, he feared that the fast would weaken the people and make them dangerously susceptible to the often-fatal disease. Reb Yisroel hung placards throughout Vilna urging all who felt weak to eat on the fast day, to stave off any threat. He did this without consulting others because he apparently realized that he would not gain a consensus for such a radical, yet - in his view - essential move. Immediately after Shacharis on Yom Kippur, he himself rose to the bimah, and according to some accounts, publicly made Kiddush and ate some cakes to encourage all those in need to follow suit. Needless to say, there were great protests, but Reb Yisroel ignored them and reportedly made his way to other shuls as well, to urge others to join him.

We join with others in wishing everyone "gmar khasime tova" ... That everyone should be enscribed for a good year.  Read More & Comment...

Sirtris and Harvard Discover New Mechanism to Slow Aging: CMS Optimal Dose Soon To Follow

09/20/2007 12:45 PM |

We don't want people living too long now, do we? Not cost-effective. Thank goodness we have the know it alls at CMS who can quickly come up with the optimal lifespan. Once you have the optimal dose for ESAs down pat why stop there? Something for Herb Kuhn and co to think about as they defend their decision and peddle their brilliance to congressional staff in the weeks ahead....

http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20070920005089&newsLang=en  Read More & Comment...

Pelosi Pays Off the Trial Bar...Introduces Nissen-Furberg FDA Premption Amendment to PDUFDA Reup

09/20/2007 10:59 AM |

As Scott Gottlieb's piece in the WSJ demonstrates, FDA reform is now all about legal pork, not public health. But what Scott didn't note is how our good friends Nissen and Furberg have played and will play a pivotal role in greasing this greed machine.

It all comes together.

The Dems -- under orders from Nancy Pelosi -- have inserted a legal loophole into the FDA reform bill that would give trial lawyers the right to sue drug companies if they don't provide additional information about the risks of drugs independent of what the FDA tells them to provide to the public. This is way to undermine the sole authority -- upheld by courts -- to determine if a drug is safe and effect. It is part of this general trend toward drug safety vigilantism which is being aided and abetted by free lancers inside and outside the FDA who leak and release hastily produced studies to Congress and to the media -- before and after duly constituted FDA review periods.

This shameful assault on the public health is fueled and funded by the trial bar who have pressured and paid for Democrats to slip this last minute provision into a bill that is required to keep the FDA operating.

Now where in the world will the trial bar get the evidence that a drug is unsafe independent of FDA decisions.

Enter Nissen, Furberg, Graham, Avorn, et. al who with the help of the nutroots on the internet (some whom are funded by the trial bar) stoke fear and provide story ideas for the media and copy for an eternally bent over medical journal establishment that is willing to receive what ever they deliver about how dangerous drugs are. No surprise that the "studies" of Furberg -- the 'unpaid' advisor to the trial bar figure prominently in the argument for what the Dems are calling a rule of construction that would allow lawyers to sue companies for not including warnings (based on studies generated by people like Nissen and Furberg) even when the FDA prohibits a company from including warnings without it's consent. The FDA does not engage -- with the exception of a handful of cranks -- in fearmongering. Guys like Nissen do it because it increases their power. And Trial Lawyer Inc. has allied with them because their fearmongering fertilizes the ground from which they reap profits.

The result? Fewer new drugs, fewer new uses, less innovation and less medical benefit.


http://online.wsj.com/article/SB119025325354433415.html?mod=opinion_main_commentaries  Read More & Comment...

On the Mark

09/20/2007 09:16 AM |

MarkMonitor that is.

Congress may soon consider legislation that would allow Americans to buy prescription drugs from foreign countries. Lawmakers who plan to vote for it should first read a new report on online pharmacies published by the respected Internet fraud expert MarkMonitor.

Published in August while Congress was on vacation, it found that of the 3,160 online pharmacies it studied, almost all of them were likely selling fake medicine.

This shocking finding should cause the congressional supporters of drug importation to change their minds, as many of their constituents will be turning to such websites for their prescriptions if the bill becomes law.

Here's a taste:

"The FDA has caught a number of pharmacies that claimed to be based in Canada -- but were operated out of China and sold medicine that was manufactured there. It's not clear how many online pharmacies are doing this, but anecdotal evidence suggests that the number is large. MarkMonitor found that 18 percent of the Web sites it evaluated were based in China, and that 12 percent were in the former Soviet Union."

And here's a link to an op-ed from today's Detroit News ...

http://www.detnews.com/apps/pbcs.dll/article?AID=/20070920/OPINION01/709200323/1008

Unsafe online pharmacies would be among the first to capitalize on legalized importation. If Americans care about their safety, they ought to log off online pharmacies. And lawmakers ought to shut down their push for drug importation.  Read More & Comment...

On the Money

09/20/2007 07:07 AM |

Last night, on the CNBC program "On the Money, Betsey McCaughey (Hudson Institute) and me were interviewed by Melissa Francis on "the drug dilemma" -- whether or not drug companies are doing enough to explain potential side-effects of their products.

Here's the video link:

http://www.cnbc.com/id/15840232?video=522416099&play=1

On the money? You decide.  Read More & Comment...

Disclosure Cuts Both Ways Senator Dorgan

09/19/2007 11:13 PM |

Peter and I received inquiries about where CMPI received our funding from a nice young man from Senator Byron Dorgan's office name Ben Klein. We both spoke to him and told Ben as we have told everyone that CMPI receives the bulk of our support -- proudly -- from pharmaceuetical and biotech firms that do the heavy lifting in the search for better medicines and search for cures. We are forthright and transparent in that respect. We offered to send a 990 once it's complete... a real one made in the USA, not imported from Canada.

We believe in disclosure and transparency and in that spirit, here's where Senator Dorgan got his money for his 2004 campaign....



Agribusiness $127,180
Communic/Electronics $442,767
Construction $26,300
Defense $57,998
Energy/Nat Resource $181,266
Finance/Insur/RealEst $458,100
Health $161,400
Lawyers & Lobbyists $562,214
Transportation $148,864
Misc Business $303,683
Labor $345,000
Ideology/Single-Issue $211,255
Other $83,360

http://www.opensecrets.org/races/sector.asp?ID=NDS1&cycle=2004&special=N

So the next time Dorgan talks issues someone should question his integrity by asking him if he gets support from such and such industry first.....

And here is where he spreads the pork... earmarks include $350,000 for leafy-spurge eradication efforts and $200,000 for the International Peace Gardens. In North Dakota? How about my backyard to replace the poison sumac?

And just so we know what the Dorgan standard for disclosure is, let's go back to 2005 when he was holding court on the Abramhoff scandal and "forgot" to disclose how he used Jack's corporate box as a fundraiser and pocketed campaign contributions that, while legal, gave the appearance of a conflict of interest...

From the Boston Globe in 2005...

The Democrat helping to lead the Senate investigation into Jack Abramoff's Indian lobbying had his own connections to the controversial lobbyist's team and clients, including using his sports arena skybox to raise money.
Senator Byron Dorgan, a North Dakota Democrat, acknowledges he got Congress in fall 2003 to press government regulators to decide, after decades of delay, whether the Mashpee Wampanoag tribe of Massachusetts deserved federal recognition.

Dorgan met with the tribe's representatives and collected at least $11,500 in political donations from Abramoff partner Michael D. Smith, who was representing the Mashpee, around the time he helped craft the legislation, according to interviews and documents obtained by the Associated Press.

The senator also didn't reimburse another tribe, the Mississippi Choctaw, for the use of Abramoff's skybox in 2001, when the tribe held a fund-raiser for him there, instead treating it as a tribal contribution. He only recently reimbursed the tribe for the box, four years later, after determining it was connected to Abramoff.

Dorgan, who is vice chairman of the Senate Indian Affairs Committee that is investigating Abramoff, says he sees no reason to step down from the probe, which he and Senator John McCain, an Arizona Republican, are leading. He said he had no idea at the time that any of the transactions were connected to Abramoff or the alleged fleecing of tribes.

''I never met Jack Abramoff, but I am appalled by what we have learned about his actions," Dorgan said Thursday. ''So I have never felt there was any conflict in my helping to lead that investigation. I think Senator McCain would agree our investigation has been relentless and that neither of us will be diverted."

Dorgan's contacts, donations, and fund-raisers involving Abramoff tribal clients and lobbying associates, as well as those of other lawmakers, have not been examined during the Senate hearings into the lobbyist's roughly $80 million in charges to the tribes.

The senator didn't volunteer the information, although he did disclose his donations in campaign reports over the years.

Larry Noble, the government's former chief election enforcement lawyer, said Dorgan should have considered stepping aside from the inquiry and should have disclosed all his own intersections with Abramoff's associates and tactics.

''I think any way you look at it, he had an obligation to disclose," Noble said. ''It is hard for anyone not to see a conflict when you're investigating the same activity you yourself were involved with."

Over the past month, the AP has reported that about four dozen lawmakers, Republicans and Democrats, collected donations from Abramoff's tribal clients and firm around the time they wrote letters to the Bush administration or Congress favorable to the tribes.

Congressional ethics rules require lawmakers to avoid even the appearance of a conflict of interest in performing official duties and accepting political money. The Justice Department is investigating whether Abramoff, already charged with fraud in a Florida case, won any undue influence through donations and favors.

Dorgan on Monday sharply criticized the AP for reporting last week that he collected $20,000 from Abramoff's firm and tribes in the period when he wrote a letter urging the Senate Appropriations Committee to fund a school construction program that Abramoff's clients and other tribes wanted.

The senator, who has Indian tribes in his state, said he long supported the program and the letter and donations had no connection.

He asserted that he never took any action or received campaign help that knowingly involved Abramoff.

Dorgan's office acknowledged he met in 2003 with representatives of the Mashpee, the Massachusetts tribe that Abramoff signed as a client and Smith represented.

The senator used his position as a member of the joint House-Senate committee that approved the final Interior Department spending bill for 2004 to craft a provision that pressed the agency to ''complete its review of the Mashpee petition as expeditiously as possible."

http://www.boston.com/news/nation/washington/articles/2005/12/03/abramoff_prober_had_ties_to_lobbyist/

Hope we've been helpful Senator. Let's have lunch soon.  Read More & Comment...

Bridges to Empowerment

09/19/2007 08:01 AM |

That's Bridges as in John FP Bridges, CMPI Senior Fellow and Assistant Professor, Department of Health Policy & Management at the Johns Hopkins Bloomberg School of Public Health.

John has co-authored a very timely, important and intriguing new paper in The Expert Review of Pharmaceoeconomic and Outcomes Research, "Promoting patient empowerment in the healthcare system: highlighting the need for patient-centered drug policy."

Timely because it coincides with many Presidential candidates releasing their plans for revitalizing the American health care system.

Important because the paper seeks to define precisely what "empowerment" means and identify its constituent variables.

And intriguing because, well, it is.

Here's what Bridges, et al consider the "Antecedents to Empowerment" ...

* Knowledge
* Health Literacy
* Patient Initiative
* Access to Services and Drugs

And "Activities for Empowerment" ...

* Information Sharing
* Doctor-Patient Communication
* Choice
* Shared Decision Making

And, as a result, the "Outcomes of Empowerment" ...

* Health Status
* Patient Satisfaction
* Self-Efficacy
* Adherence

Here is a link to the complete article:

Download file

Viva Bridges!  Read More & Comment...

Suicide Watch Whitewash

09/18/2007 11:07 AM |

There are some bloggers anxious to absolve themselves of responsibility for the jump in suicides because of SSRI related fearmongering who are claiming that the 2004 data is just a blip.

Nice try with incomplete data. The jump in suicides was pronounced among youths but increased across ages 10-64 from 2003-2004. The jump in 2004 came after a 15 year decline among kids. And if the suicide rate decline in 2005 -- which I hope is the case -- holds up among kids specifically it only goes to show that the fearmongering was the principal factor not the other way 'round.

At least such pundits like Phil Dawdy of Furious Season with whom I rarely agree but whose trenchant style I admire are seeking to offer an alternative and plausible data-driven explanation. http://www.furiousseasons.com

They are not claiming -- like David Healy -- that the jump is a result of treating kids with atypicals. Healy, who is now a paid consultant to the trial bar suing Lilly and other companies who make such drugs has no shame. What a tool.  Read More & Comment...

Hard Evidence

09/18/2007 07:56 AM |

From The Times of London ...

Fake world of the Viagra plotters

For tens of thousands of men the medicines offered by Ashish Halai and his gang appeared to be the answer to two of their most worrying and embarrassing health concerns: impotence and baldness.

But the unsuspecting customers, buying what they thought were Viagra and Propecia, were victims of one of the most ambitious and elaborate of counterfeiting crimes. Halai and his associates were buying fake drugs from Chinese suppliers for as little as 25p a tablet and selling them for up to £20.

Details of their vast network – stretching from Britain to Hong Kong, Dubai, the US and the Bahamas – emerged yesterday as justice finally caught up with the conmen.

In the largest drug counterfeiting case in Britain, and after a trial lasting more than seven months, Halai, 33, was jailed at Kingston Crown Court for four and a half years as one of the key players in the plot.

From his £1 million home in Borehamwood, Hertfordshire, he helped to mastermind an operation in which fake pills were produced at secret factories in China and Pakistan and smuggled to the US and Europe. The rewards, the court was told, were “immense”.

The investigation, the largest conducted by the Medicines and Health-care products Regulatory Agency (MHRA), uncovered profits of more than £2 million. The agency said that this was the “tip of the iceberg”.

“The geographical spread was global and the financial rewards were immense,” Sandip Patel, for the prosecution, told the court.

The case dates back to 2003 and 2004, when counterfeit batches of Viagra and Cialis, impotence drugs made by Pfizer and Eli Lilly, were seized while being smuggled into Heathrow and Stansted airports.

The MHRA immediately launched an investigation which alerted them to a major manufacturing and smuggling operation. Samples showed that the medicines contained about 90 per cent of the active pharmaceutical ingredients found in genuine tablets. Most of the fake pills were sold via the In 2003 the MHRA contacted the US Food and Drug Administration, which seized 8,000 packages of Viagra in Miami. Then, in July 2003, MHRA officers seized more than 120,000 fake Viagra tablets. internet, but some found their way into chemists were they were sold as prescription medicines.

The full story can be found here:

http://www.timesonline.co.uk/tol/life_and_style/health/article2477868.ece?EMC-Bltn

Caveat emptor is not sound health care policy.  Read More & Comment...

FDA Approves Genetic Test for Warfarin Dosing

09/18/2007 06:42 AM |

See what I mean?

This is a lot better than bureaucrats guessing...

http://ap.google.com/article/ALeqM5iX6mwtAXZaZ-NdJ3C9SQh4nOBrqQ  Read More & Comment...

The Right Path for Optimal Dosing

09/18/2007 06:37 AM |

Genomas has lead the way to identifying the genetic links to painful side effects associated with statins. (I was honored to have been able to use their gene chip to guide my selection of statins.) This is the right and cost effective way of optimizing drug selection...


"Research by Genomas and collaborators at Hartford Hospital, University of California San Francisco and Yale has demonstrated a strong association between myalgia (muscle pain) arising during statin treatment and variability in genes related to pain perception. The research has been published in the September issue of the leading neurological journal Muscle and Nerve*, published by Wiley InterScience. The findings suggest that serotonergic neurotransmitter receptor function may contribute to the muscle pain induced by statins in some patients inheriting specific variants of the receptor genes. "

For more information go to http://www.genomas.net  Read More & Comment...

Revlimid Runs a NICE Gauntlet, FDA Micromanaging ESA Dosing

09/18/2007 05:49 AM |

Steve Usdin makes the point in this week's Biocentury that companies who fail to come up with personalized algorithms for dosing and medicines will find themselves at the mercy of micromanagers and second-guessers at FDA panels, CMS and cost cutters generally. But the challenges, legal, economic, regulatory are great in this era of of no good deed going unpunished or sued. As Usdin writes "These studies, along with observational data, paint a complex, nuanced picture. Indeed, the panel members spent much of the meeting focused on an apparent paradox: attempting to increase Hb in kidney disease patients to levels approximating those in healthy individuals is harmful, but actually achieving higher Hb levels is usually beneficial.
The committee also grappled with the potential association between increased mortality risk and low response rates to ESAs, a circumstance that could affect as many as 40% of dialysis patients."

So much for the value of randomized trials in personalizing dosing regimens.


Meanwhile, as if we did not need another reminder that it won't stop at ESAs, Biocentury has a story about how patients waiting for Revlimid in the UK will have to wait years to produce comparative effectiveness data of the sort that Hillary's Best Practice Institute will generate.

According to Biocentury:

"Multiple myeloma patients in the U.K. will have only limited
access to one of the newer drugs for the disease, Velcade bortezomib, as a result of NICE’s recent recommendation to shave the number of patients who would be indicated for the drug. And they will have limited access in the foreseeable future
to another new drug, Revlimid lenalidomide from Celgene Corp., which is in no hurry to undergo the NICE process..."

Who can blame them, because it takes at least a year and, in the case of the UK, years to get reimbursement approval.

The pace is going to be slower in the U.K. Although Revlimid is available to patients who have private insurance, going through the country’s reimbursement
process is not near the top of CELG’s list because NICE takes such a long time.
Indeed, Gill said the company does not even have a timeline for when it will begin the process. “We will work with NICE as expeditiously as possible, but historically it takes years.”

Best Practice Indeed  Read More & Comment...

Watch How the Fearmongers Manhandle This Mound of Information

09/17/2007 03:49 PM |

Two U.S. Department of Health and Human Services agencies will collaborate in the most comprehensive study to date of prescription medications used to treat attention deficit hyperactivity disorder (ADHD) and the potential for increased risk of heart attack, stroke or other cardiovascular problems.

Thank you Dr. Nissen and Dr. Furberg....

AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks With ADHD Medications

Researchers supported by the Agency for Healthcare Research and Quality and the U.S. Food and Drug Administration will examine the clinical data of about 500,000 children and adults who have taken medications used to treat ADHD, to determine whether those drugs increase cardiovascular risks.

Because medications used to treat ADHD can increase heart rate and blood pressure, there are concerns about the drugs' potential to increase cardiac risks. It is also thought these risks may be different for adults and children, but more evidence is needed about the long-term effects of using ADHD medications.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01700.html  Read More & Comment...

What Nissen is Missin'

09/17/2007 02:12 PM |

The attack on Avandia is really an attack on the FDa's authority wrapped up in a bogus concern about the risk of cardiovascular death associated with diabetes. Treatment of type 2 diabetes requires management of many diseases that contribute to heart attacks. That includes managing high cholesterol which of course Avandia is associated with. So it would seem logical to identify which patients on Avandia who had heart attacks were not on statins (something the FDA numbers crunchers did). Nissen and co simply gloss over this issue. But good diabetes management with respect to MI requires it. So why not make this an issue of improving CV outcomes instead of Avandia and the FDA?

See Gina Kolata's excellent article in the NYT from Aug 2007 to see how it can be done:

http://www.nytimes.com/2007/08/20/health/20diabetes.html?pagewanted=3&ei=5070&en=f729f5b46fa2a74d&ex=1190174400  Read More & Comment...

Worst Best Practice

09/17/2007 01:00 PM |

The Washington Times editorializes on the stupid coverage decision CMS made on ESAs. Hillary has made her Best Practice Institute a cornerstone of her new "American Health Choices Plan" (has anyone been more manipulative in the use of the English language than Hillary) Yes, you will have choices, much like the choices you get from a elementary school cafeteria. The Best Practice Institute will tell which drugs at which dose at which time without regard to individual variation because that's what is required to cut $100 billion from health care spending. That and price controls on new drugs. You think a one size fits all dose for ESAs is a one shot deal (that ignores the impact of cost effectiveness or quality of life relative to transfusions). Think again. If CMS gets the power to impose a dose specific criteria on one drug, it can do it on ALL medicines.

That's Hillary's plan for Health Care Choices....

http://washingtontimes.com/article/20070916/EDITORIAL/109160019/1013/EDITORIAL  Read More & Comment...

Copping a Plea

09/17/2007 08:14 AM |

In April of 2006 James Copping (Principal Administrator, European Commission Enterprise & Industry Directorate-General) had this to say about rethinking the EU Commission’s position on information-to-patients:

“From the Commission’s point of view, we want a system where patients can be empowered to take an equal part in health care decisions. To do that, they need more information and we all want to make high-quality information available as soon as possible. We believe that all stakeholders have a role to play to provide this information, but the tricky issue for us is to find the appropriate framework which national regulatory authorities can live with.”

Copping continued as to possible ways to achieve that goal:

“The pharmaceutical industry has a lot to contribute because of their resources, skills and expertise and we have seen in the working group that the industry plays a constructive part. It’s amazing to me that an industry which plays such an important part of our health care is often seen on par with the tobacco or the oil industry. It’s not clear to me why this is the case, but we need to develop good working relationships between all of us. We all agree that we need good quality information, but none of us can do it alone.”

In April of 2007 the Director of the Enterprise and Industry Directorate General of the European Commission released its report for consultation on "current practice with regard to provision of information to patients on medicinal products." The report focuses on information publicly available on the internet from regulatory bodies or official sources in member states -- mostly of information on package leaflets, databases of approved drugs and regulatory reports, and other sources of information from regulatory bodies on approved drugs.

The report concludes, "Member States may not be in a position to fully address patients' needs in terms of the substance of information and the access via different means. In turn, the pharmaceutical industry possesses the key information on their medicines but this information can currently not be made available to patients and healthcare professionals through Europe."

The idea of a public-private partnership stems from the recent second progress report of the European Commission's High Level Pharmaceutical Forum that proposes "to organise a platform to bring together relevant stakeholders to explore ways to exchange good practices and on ways to overcome barriers to accessing information." Although the Commission does not support direct to consumer advertising, they are clearly suggesting that reliable information could come jointly from both industry and regulatory bodies.

Indeed, efforts that include industry (and their proven ability to communicate health care information to patients – aka consumers – in partnership with governments (with their ability to use the bully pulpit on behalf of the public health) is a potent alliance and the right way to proceed.

But not everyone agrees.

Here’s what the British Medical Journal has to say in a recent editorial:

“We think that a partnership between drug companies and drug regulatory authorities in the area of information … would be confusing. Therefore, we propose two areas of real partnership with the drug industry that would reinforce public trust in the system.

The first would entail a real commitment to waive confidentiality and give full access to data on the effectiveness and safety of drugs. Giving full access to all clinical trial protocols (not just those that are registered for publication purposes) and to the periodic safety update reports available to regulatory agencies would enhance transparency.”

Does the BMJ really think that practicing physicians have the time or inclination to plow through thousands of pages of clinical trial data? And, anyway, isn’t that besides the point?

If “more information” is good for physicians – why isn’t it equally good for patients?

Or does the BMJ believe that only medical professionals should have access to information?

The BMJ editorial concludes by saying that"

“The most sensible way to protect public health would be to identify sources of unbiased and systematically reviewed information and maintain the current European legislation on drug promotion, while reinforcing the role of the European Medicines Evaluation Agency.”

Here’s a link to the complete BMJ editorial:

http://www.ifpma.org/PressReviewEmail/PressReviewDetail.aspx?nID=8133&SD=LoB8AhN%2fJP9w%3d%3d

Is more government control and a continued policy of information denied to patients the BMJ’s idea of progress?  Read More & Comment...

I left my heart (medicine) in San Francisco

09/14/2007 04:00 AM |

What? No "drugs from Canada" as the great panacea? How times change. Attention members of Congress who are still beating the dead horse of foreign drug importation ...

Healthy San Francisco is a new program that offers free or subsidized health care to all 82,000 San Francisco adults without insurance. It is financed mostly by the city which, according to the New York Times, “is gambling that it can provide universal and sensibly managed care to the uninsured for about the amount being spent on their treatment now, often in emergency rooms.”

The Times reports that “Healthy San Francisco provides uninsured San Franciscans with access to 14 city health clinics and 8 affiliated community clinics, with an emphasis on prevention and managing chronic disease. It is, however, not the same as insurance because it does not cover residents once they leave the city.”

Until November, enrollment will be limited to those living below the federal poverty line ($10,210 for a single person; $20,650 for a family of four). Then it will open to any resident who has been uninsured for at least 90 days, regardless of income or immigration status.

The coverage is not portable and city officials believe that people with private insurance will have little incentive to drop their policies to take advantage of the city’s cut-rate services.

Patients are asked to contribute nominal amounts through membership fees and co-payments that vary by income. Those from families with incomes below the federal poverty line pay nothing. Those who earn more pay quarterly fees that range from $60 to $675, which is the rate for those with incomes above 500 percent of the poverty level ($51,050 for a single; $103,250 for a family of four). That is where the subsidy ends. The co-payments range from $10 to $20 for a clinic visit and from $200 to $350 for an inpatient stay.

A final financing mechanism has placed the program in legal jeopardy. To make sure the new safety net does not encourage businesses to drop their private insurance, the city in January will begin requiring employers with more than 20 workers to contribute a set amount to health care. The Healthy San Francisco program is one of several possible destinations for that money, with others being private insurance or health savings accounts.

The full New York Times story can be found here:

http://www.nytimes.com/2007/09/14/us/14health.html?_r=1&hporef=slogin

Little cable cars riding half-way to the stars not included.  Read More & Comment...

20/20 Foresight

09/13/2007 12:52 PM |

From today's WSJ ...

Sick Sob Stories

By JOHN STOSSEL
September 13, 2007

In Michael Moore's movie "Sicko," a widow named Julie Pierce tells a tearful story: Her husband died of kidney cancer after their health-insurance company denied payment for a bone-marrow transplant that might have saved his life. Ms. Pierce's rage is palpable as she repeats the word her insurers used in response to her husband's request. "They denied it," she sneers. "Said it was 'experimental.'"

Viewers of the documentary are meant to understand that "experimental" is health-insurance code for "expensive," and that Ms. Pierce's husband was left to die for the sake of profit. According to Mr. Moore's movie, "Any payment for a claim is referred to as a medical loss," and when a claim is denied, "it's a savings to the company."

But Mr. Moore is so busy following the money that he doesn't take the time to follow the science. Treating cancer patients with bone-marrow transplants has a dubious history.

Twenty years ago, many oncologists believed that bone-marrow transplants, along with high doses of chemotherapy, might offer a cure for breast cancer. Insurance companies refused to pay, calling the treatment experimental and unproven. Breast-cancer sufferers went to court: In one case, a jury awarded $77 million to the family of a woman who was denied payment for the treatment. Wives and mothers told heart-rending stories in newspapers and on TV. Politicians quickly moved to guarantee the treatment to all breast-cancer patients. Ten state legislatures mandated that every insurance policy cover bone-marrow transplantation for breast-cancer patients. Amid the media circus and political self-congratulation, the question of whether bone-marrow transplants are medically effective faded into the background.

The sad truth is that the treatment isn't effective. When researchers released the results of their clinical trials to the American Society of Clinical Oncology in 1999, they showed that the treatment offered no benefit. Worse, it often killed women faster than their cancer, and caused them unnecessary pain. At a time when their health was at its greatest risk, more than 30,000 women were exposed to an invasive, harmful and ultimately useless treatment that the National Institutes of Health no longer recommends. But only one state legislature has repealed its law requiring insurance companies to pay for the treatment. Some doctors believe bone-marrow transplants might help kidney cancer patients, and the NIH is conducting clinical trials to find out. Until the treatment has been shown to do more good than harm, insurers are reluctant to pay for it.

Mr. Moore claims that because private insurance companies are driven by profit, they will always deny care to deserving patients. For this reason, he argues, profit-making health-insurance companies should be abolished, our health- care dollars turned over to the government, and the U.S. should institute a health-care system like the ones in Canada, Britain or France. But does Mr. Moore think, even for a second, that any of the government systems he touts in his movie would have provided a bone-marrow transplant to Ms. Pierce's husband? Fat chance.

When government is in charge of health care, the result is not that everyone gets access to experimental treatments, but that people get less of the care that is absolutely necessary. At any given time, just under a million Canadians are on waiting lists to receive care, and one in eight British patients must wait more than a year for hospital treatment. Canadian Karen Jepp, who gave birth to quadruplets last month, had to fly to Montana for the delivery: neonatal units in her own country had no room.

Rationing in Britain is so severe that one hospital recently tried saving money by not changing bed-sheets between patients. Instead of washing sheets, the staff was encouraged to just turn them over, British papers report. The wait for an appointment with a dentist is so long that people are using pliers to pull out their own rotting teeth.

Patients in countries with government-run health care can't get timely access to many basic medical treatments, never mind experimental treatments. That's why, if you suffer from cancer, you're better off in the U.S., which is home to the newest treatments and where patients have access to the best diagnostic equipment. People diagnosed with cancer in America have a better chance of living a full life than people in countries with socialized systems. Among women diagnosed with breast cancer, only one-quarter die in the U.S., compared to one-third in France and nearly half in the United Kingdom.

Mr. Moore thinks that profit is the enemy and government is the answer. The opposite is true. Profit is what has created the amazing scientific innovations that the U.S. offers to the world. If government takes over, innovation slows, health care is rationed, and spending is controlled by politicians more influenced by the sob story of the moment than by medical science.  Read More & Comment...

FDA: All the way with ESAs

09/12/2007 01:36 PM |

FDA Adcomm decides no label changes for ESA use with respect to kidney patients on dialysis and can't decide on an optimal dose...What, no micromanagement of medicine? How refreshing.

Meanwhile as Scott Gottlieb points out, CMS is likely not to make any coverage decision because...it already has. Bundled payments for ESAs based on one size fits all hemocrit levels are due in 2010 for the Medicare renal program. We have been here before. Price per dose limits in the 90s led to increase in death among kidney patients.

http://www.boston.com/business/globe/articles/2007/09/12/panel_says_anemia_drug_doses_ok_as_is/  Read More & Comment...