No soap - radio

05/02/2008 10:46 AM |

Bizzaro non sequitor paragraph in today’s New York Times article on the the Genetic Information Nondiscrimination Act:

“Ultimately unlocking all these genetic secrets will make the whole idea of private health insurance obsolete,” said Karen Pollitz, director of the Health Policy Institute at Georgetown University.

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Value vs. Volume

05/02/2008 07:34 AM |

Yesterday in Chicago HHS Secretary Mike Leavitt kicked off the 28th annual Midwest Business Group on Health conference (smartly themed “Survivor:  Health Benefits Island”).  He made some interesting points:

The first is that we need to redesign our healthcare system so that we reward “value rather than volume.”  No argument there.  It’s also very much in keeping with what Senator McCain is talking about these days.

He then turned his attention to the HHS “efficiency roadmap.”  Lots of good initiatives.  (I know, there are always a lot of “good initiatives.”)  What was missing, however, was how to overcome one of the most significant roadblocks – state lines.  Specifically, in addressing a group made up of large employers, the Secretary didn’t discuss insurance deregulation as a strategy towards more affordable, accessible, and patient-centered coverage.  This must be a key strategy in the “value vs. volume” proposition.

He spent the lion’s share of his remarks (and productively so) talking about the need for inter-operability of healthcare IT platforms – where HHS has helped to both design and implement some successful programs lead the still nascent national dialogue. 

One comment he made is worth repeating for both its wit and honesty.  Leavitt quipped that “the wonderful thing about healthcare standards is that there are so many to choose from.”

And may we all live in interesting times.


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Janet Has A Job For You

05/01/2008 11:42 AM |

Finally the FDA gets the funds and most importantly the fast track hiring authority to add about 1300 new scientists to its payroll.  Much of the problem had to do with the fact that because of bureaucratic mutation created by former HHS Sec Thompson, Woodcock and others had to go through a centralized HHS hiring system that took months, set salaries, etc.   That was fixed by the current HHS team.    Now the question is whether Janet has been the resources to train newcomers consistent with science-based Critical Path approach. 

Credit must also be given to Congressman Dingell, Congresswoman DelLauro and staff for pressing hard for more funding and hiring authority.  Sometimes people can work together for the public health. 

www.reuters.com/article/latestCrisis/idUSN30551443
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The Whining States of America

05/01/2008 09:05 AM |

The Gallup-Healthways Well-being Index claims that 47 percent of all Americans are struggling.  How is that defined?

"The Gallup-Healthways Well-Being Index asks Americans to evaluate their lives by imagining a "ladder" with steps numbered from 0 to 10, where "0" represents the worst possible life and "10" represents the best possible life. Nationally, 49% of Americans say that they presently stand on steps 7 or higher of the ladder. When asked where they will stand about five years from now, Americans report that they expect to stand on steps 8 or higher. Gallup considers this group of Americans to be "thriving." Thriving Americans' have their basic needs (such as food and shelter) met, and they have higher incomes, are less burdened by disease, report fewer sick days, and have better work environments. While nearly half of Americans fall into this category, the percentage of citizens in the thriving group is down from 60% in 2006.

On the low end of the spectrum, 4% of U.S. residents say they presently stand on steps 0 to 4 of the ladder. When asked where they will stand five years from now, Americans in this group report that they expect to stand on steps 0 to 4 of the ladder, as well. Gallup considers this group of Americans to be "suffering." Suffering Americans report that they have less access to basic needs such as food, shelter, and healthcare. They are also more likely to be burdened by disease, report more sick days, and are more likely to be divorced or widowed."

So how does Gallup arrive at a definition of "struggling?"

"Americans that Gallup does not classify as thriving or suffering are considered to be "struggling." The percentage of U.S. residents who are struggling has increased to 47% from 37% in 2006."

Hmmm.  Has anyone  at Gallup read Goldilocks and The Three Bears?  Or is it just that Americans are and always have been a striving culture.  Or is it a function of everyone pursuing happiness?  In any event, none of it explains the comment by CDC director Julie Gerbeding who equates the state with the misleading factoid that the US health care system ranks 37th in the world/....who is writing HER speeches....

Meanwhile here is the most revealing finding of the survey:

"Americans' reported level of happiness and enjoyment peaked on Easter Sunday, March 23, with New Year's Day coming in a close second. Super Bowl Sunday, Feb. 3, was also among the top 10 days that Americans reported the highest levels of happiness and enjoyment."

To me and Peter, any day the Yankees win is a great day...Looks like we will be struggling or suffering through 2008.

www.gallup.com/poll/106906/Nearly-Many-Americans-Struggling-Thriving.aspx

 

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Patent Nonsense

05/01/2008 07:53 AM |

This week, the World Health Organization’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property is gathered in Geneva to finalize its report to the general body for how the international community can best aid developing countries.
Many attendees support a proposal to replace drug patents with a “prize” system, wherein governments offer monetary rewards for new pharmaceuticals. A central WHO bureaucracy would decide which diseases are worth researching, establish prizes accordingly and then put the formulas into the public domain, allowing anyone to produce generics.

What could justify this overhaul? Proponents argue that patents keep drug prices artificially high and that pharmaceutical firms spend too much money on “lifestyle” drugs aimed at Westerners and too little on treatments for developing-world diseases.

Have a look at this article for further discussion of this foolishness:

www.metro.us/metro/blog/my_view/entry/Theres_a_prize_in_every_box/12382.html

The patent system doesn’t cause firms to ignore the developing world. Roughly half the research projects into Third World diseases are run by drug companies. The claim that prices keep drugs from poor patients is equally untrue. The reality? Developing countries lack the infrastructure for drug distribution. As the WHO’s HIV division director put it in 2006: “It is very obvious that the elephant in the room is not the current price of drugs. The real obstacle is the fragility of the health systems. You have health infrastructure that is dilapidated, and supply chains that don’t exist.”

Prizes might work in industries defined by “eureka” achievements like space travel. But drugs come from a long, incremental process of testing and retesting. Prizes only reward breakthroughs, not intermediate steps. Replacing pharmaceutical patents with a prize system would do untold damage to millions of poor patients.

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Jim Crow Medicine and Comparative Effectiveness

04/30/2008 11:48 AM |

One effect of comparative effectiveness: it locks in racial disparities in the treatment of chronic illnesses that lead to higher rates of death among African-Americans. Cost containment is achieved by letting minorities die more often.

Gene Variant Protects Black Heart Failure Patients

MONDAY, April 21 (HealthDay News) — Researchers have discovered a gene variant carried by about 40 percent of blacks that protects them after heart failure as much as widely used beta blocker drugs do.

The finding explains the puzzling results reported in trials of beta blocker therapy in black people, said Dr. Stephen B. Liggett, a professor of medicine and physiology at the University of Maryland, and co-author of a report in the April 20 online issue of Nature Medicine.

"To our knowledge, this is the first case where a genetic variant mimics the activity of a drug used to treat a disease," Liggett said.

The finding won't have an immediate effect on treatment of heart failure, the progressive loss of ability to pump blood that affects an estimated 5 million Americans, said study co-author Dr. Gerald W. Dorn II, director of the Center for Pharmacogenomics at Washington University in St. Louis. Doctors can continue to prescribe beta blockers for people with heart failure, black or white, since the drugs have little risk, he said.

But there should be an effect on future medical practice, Dorn said. "One idea in the future of drug discovery is that we will not only need to tailor therapy for individual genetic makeup but also take genetic makeup into consideration in drug testing," he explained.

Comparative effectiveness is completely ignoring such advances and the life saving benefits they bring. Remember Nitromed?

In this case people with the variant might not need a beta-blocker or as high dose. Those without will need it, Still other variations might lead to developing other regimens.

Liggett noted: “Our idea is not to replace the physician's judgment, but to give a handle on which drugs they might want to push to higher levels and which are less likely to be helpful for specific individuals.”

Unlike population-based comparative effectiveness which ignores individual differences that – for African Americans suffering from diabetes, hypertension and breast cancer – could mean life and death. 

Which is why comparative effectiveness is just Jim Crow medicine unless it’s put on a personalized path. 

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The McCain Health Care Clinic

04/30/2008 09:56 AM |

Doug Holz Eakin, John McCain's policy chief and Carly Fiorina, McCain campaign chair ran a conference call for the media on McCain's emerging health care vision.  In essence it is this:  give people money to buy coverage and seek out care anywhere that prevents disease and rewards providers and insurers that do the best job treating illnesses.  Instead of an insurance system that profits from finding ways not to cover people, McCain would find ways to get insurers to compete to treat people in high quality settings and get rewarded accordingly.  Consumers would have information and dollars to seek out service in this new market.   How about that?  Sick people being sought after by insurance companies -- much like hungry people are sought after by restaurants and grocery stores.

This is an emerging and provocative vision.  More to come...

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Follow-on O Ship of State

04/29/2008 08:37 AM |

Excellent piece by Bryan Liang in the Los Angeles Times:

Don’t Compromise the Safety of Biotech Drugs

By Bryan A. Liang

A toy plane has a handful of parts. A Boeing 747 has several million. This makes sense. Toy planes are small, simple models, while 747s are large, high-performance aircraft that travel more than 500 mph with thousands of component systems acting together. The model costs a few dollars because it's easy to manufacture. The 747 costs about $225 million because of its highly complex nature, testing and the need to ensure safety.

The comparison is worth keeping in mind as the debate heats up over "follow-on" biologics. Biologics are today's most advanced medicines, fully tested biotechnology protein drugs that provide targeted therapy to victims of cancer and other diseases. Follow-on biologics are the second or subsequent versions, but they are not identical.

U.S. spending on them reflects the importance of these drugs in medicine's arsenal. Biologics represent the fasting-growing sector in the medicines market, with more than $30 billion spent on these drugs each year. Indeed, the top five drugs in terms of Medicare expenditures administered in physicians' offices are biologics. By 2010, worldwide spending on biologics is estimated to grow to $10 billion, and biologics will make up nearly half of all newly approved medicines. Hence, many policymakers are focused on reducing the costs associated with these drugs.

Congressional legislation is pending that would allow the sale of follow-on biologics without requiring extensive testing -- essentially following the same model used for approval of generic forms of traditional prescription drugs.

But most drugs we're familiar with, like the pills we get from the pharmacy, are "small-molecule" drugs -- simple chemical compounds. They can be easily manufactured and identically copied. The anti-convulsant drug valproic acid, for example, has a total of just 26 atoms.

Identical to the brand-name version, these generics can "piggyback" on a brand-name company's testing. That's reasonable. These small-molecule drugs -- which typically are made up of a total of 20 to 100 atoms -- can be copied perfectly. So they don't need independent safety testing, cost less to make and are cheaper -- allowing more patients to obtain the medical benefits.

But biologics are far more complex. The brand-name drug Herceptin, a biologic that's widely used to treat cancer, is made up of a total of roughly 25,000 atoms. Large biologics can have millions of atoms.

Biologics aren't made by combining chemicals in a flask. They're made by life forms such as cells, yeast and bacteria. Like humans, these life forms exhibit diversity in metabolism and composition, making the final product a unique, heterogeneous mix that cannot be copied exactly. So follow-on biologic forms of a drug can only be similar to the original, not identical.

Because of the complexity of biologics, there's more regulation. In comparison with common chemical drugs that can have generic versions -- such as penicillin -- which only require 50 to 60 manufacturing tests for safety and quality, biologics require at least four times that number.

So the policy challenge is to provide incentives for innovation while also ensuring that any follow-on forms of biologics that enter the market are safe.

The key lies in something called "data exclusivity," which is a legal mechanism for allowing a company to keep confidential the data associated with a drug's development. Data exclusivity usually lasts for several years and spurs innovation by protecting new inventions. This is the current rule for small-molecule drugs, and it should be applied to biologics as well. Strong data exclusivity is critical for biologics, which are about 50% more expensive to develop than small-molecule medicines.

However, the current state of science makes ensuring safety of follow-on biologics difficult. Currently, the technology to map out the exact chemical structure and function of one large biologic versus another is not available. That makes safety reviews inexact. And follow-on forms may induce unpredictable adverse reactions.

Several years ago, a fully tested biologic created in the U.S. was cooperatively licensed overseas to be made in Europe. But the new version caused patients to suffer "pure red cell aplasia," whereby their bodies could not make red blood cells. This may have contributed to the deaths of some patients and permanent injury to others. Yet today, after eight years of research, the cause of these reactions is still unknown.

If even cooperative company efforts can result in unpredictable adverse reactions, any follow-on product that does not undergo full testing should be of concern. Recognizing this reality, the European Union has developed a system of assessment that requires clinical testing of follow-on products in Europe before approval.

U.S. policymakers should take note. Relevant clinical data and testing should be required to ensure safety of any follow-on biologic product being considered for patient use in the U.S. And appropriate data exclusivity should be put in place to foster innovation.

If chemical drugs were toy planes, biologics would be 747s, the cutting edge of medicine. Because of their complexity, any follow-on forms must be held to a higher safety standard. As we have learned in aviation, safety is no accident.

Bryan A. Liang is executive director of the Institute of Health Law Studies, California Western School of Law and co-director of the San Diego Center for Patient Safety, UC San Diego School of Medicine.

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Scientific research with an asterisk

04/29/2008 08:31 AM |

From today's edition of the Boston Globe:

Scientific research with an asterisk

By David A. Shaywitz and Dennis A. Ausiello

CONSIDER an academic scientist - we'll call him Louis - who receives funding from the beverage industry, the textile industry, and the livestock industry, and ultimately generates profound new scientific insights, beneficial both to the sponsoring companies and to the world as a whole. Are these accomplishments diminished because the work was industry funded? Should Louis - Pasteur - have an asterisk next to his name?

That's the implication of a recent New York Times profile of three academic researchers from New England who have pledged to decline industry funding and "have lost their asterisks."

The notion that academic researchers who partner with industry are intrinsically tainted reflects a misunderstanding of the importance and quality of industry research, and the role industry plays in bringing new drugs to the patients who need them.

While most of the original insights leading to new drugs and devices likely derive, at least in part, from the work of academic scientists, turning these preliminary advances into FDA-approved treatments required an exceptional investment by industry, and vital partnerships between academic investigators and company scientists.

The gaping distance between promising lab result and approved drug is apparent to anyone who has tried to reconcile the breathless news reports touting "scientific breakthrough" with the paucity of options available for patients suffering from any number of devastating medical conditions. In the last 10 years, for example, there have been more then 7,000 academic papers published on pancreatic cancer, but not a single breakthrough treatment.

The primary reason for this gap: The human body is complicated, and our understanding limited. In many cases, we are still struggling to figure out the molecular basis for important diseases. In other conditions, even when the cause is clear, designing a drug capable of selectively correcting the defect while not causing new problems, is a monumental challenge.

To overcome these hurdles, there is a need for more, not less, interaction between academic physician scientists and their counterparts in industry, engagement that should occur at every stage of the drug development process.

Our own experiences with difficult science and sick patients has convinced us that the battle is not drug companies vs. academics, but rather between dreadful diseases and the medical researchers who are trying to subdue them.

Unfortunately, industry critics often lose sight of the big picture, and routinely stigmatize pharmaceutical researchers and their academic collaborators. Young academic investigators are often counseled against "selling out" and pursuing a career in pharmaceutical research, despite the exciting drug-development opportunities such a choice might afford. Senior university researchers who might contribute considerable wisdom to drug discovery efforts are reviled in the press if they associate with industry in any way, even though these relationships are vital for the creation of new medicines.

Finally, of course, there is the money. Because pharmaceutical companies are for-profit entities, conventional wisdom holds that any data they publish should be suspect. In fact, pharmaceutical research is tightly regulated, and industry-sponsored clinical studies are typically performed in a rigorous, consistent, and transparent fashion that would be the envy of many academics. To the extent some industry studies fall short, the problem generally lies not in the results obtained, but rather in the questions never asked - a critique that applies at least as well to the pharma-bashing studies now so popular in certain medical journals.

Also puzzling is the suggestion that it is improper for drug companies to solicit the perspective of academic experts, and immoral (or at least asterisk-worthy) for experts to accept financial compensation for their time. Expert insight may accelerate the delivery of new treatments to patients, and it seems disrespectful to suggest this time should not be valued.

Still, although the relationship between universities and industry should be broadened, useful and transparent guidelines must be developed to get this relationship right. Ultimately, these interactions must be defined, protected and enhanced if the medical community is to deliver on its commitment to secure the health and well-being of patients.

Dr. David A. Shaywitz is a management consultant in New Jersey. Dr. Dennis A. Ausiello is the physician-in-chief of Massachusetts General Hospital and a director at Pfizer.

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The Moose on the Table

04/29/2008 08:12 AM |

Yesterday Senator McCain made clear the difference between his position on healthcare and that of Senators Clinton and Obama:

Senator McCain believes in free market solutions and he told the American people an important truth – the warm and fuzzy sounding policy of “universal care” is really the harsh reality of “government care.”

He then put the moose on the table – insurance deregulation.  And it’s about time.

Now that’s straight talk.  Express.

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Getting ugly early

04/29/2008 07:55 AM |

Gail Wilensky on what happens if some of the ideas presented by our candidates for the White House fail:

"The real answer is -- we don't know.  But if these ideas don't work the alternatives are largely disturbing:  price controls, stifled innovation and stemming the spread of new technology.  It gets ugly real fast."


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Group Urges Ban on Medical Giveaways

04/28/2008 04:27 PM |

By GARDINER HARRIS
Published: April 28, 2008

Drug and medical device companies should be banned from offering free food, gifts, travel and ghost-writing services to doctors, staff members and students in all 129 of the nation’s medical colleges, an influential college association has concluded.

The proposed ban is the result of a two-year effort by the group, the Association of American Medical Colleges, to create a model policy governing interactions between the schools and industry. While schools can ignore the association’s advice, most follow its recommendations.

Rob Restuccia, executive director of the Prescription Project, a nonprofit group dedicated to eliminating conflicts of interest in medicine, said the report would transform medical education.

Most medical schools do not have strong conflict-of-interest policies, and this report will change that, Mr. Restuccia said.

The rules would apply only to medical schools, but they could have enormous influence across medicine, said Dr. David Rothman, president of the Institute on Medicine as a Profession at Columbia University.

We’re hoping the example set by academic medical colleges will be contagious, Dr. Rothman said.

"Drug companies spend billions wooing doctors” more than they spend on research or consumer advertising. Medical schools, packed with prominent professors and impressionable trainees, are particularly attractive marketing targets."

Okay.

Here are the facts from a November 2006 GAO report:

Drug companies spent less in 2005 on DTC advertising ($4.2 billion) than on promotion to physicians ($7.2 billion) or research and development ($31.4 billion). www.gao.gov/htext/d0754.html

Now some stuff Gardiner left out:

The Prescription Project is funded by trial attorneys who sue drug companies. IMAP gets millions from George Soros.

And the report never uses the word "ban.”

Here's what is does say, courtesy of Thomas Sullivan's blog:

www.policymed.com/

For Continuing Medical Education (CME)

Academic medical centers offering CME programs should develop audit mechanisms to assure compliance with the standards of the Accreditation Council for Continuing Medical Education (ACCME), including those with respect to content validation and meals.

Academic medical centers should establish a central CME office through which all requests for industry support and receipt of funds for CME activity are coordinated and overseen.

To the extent that educational programs for physicians are supported by any commercial entity, including pharmaceutical, device, equipment, and service entities, the programs should be offered only by ACCME-accredited providers according to ACCME standards.

In respect to CME these are all very reasonable recommendations, and most universities have already undertaken significant effort to achieve these goals.

The document covers many other things not directly related to CME including:

• Gifts to individuals (Prohibiting)
• Pharmaceutical samples, (Central Distribution)
• Site access by pharmaceutical representatives, (Limited to appointment or invitation, student participation limited, more MD’s, PhD’s and PharmD’s)
• Site access by device manufacturer representatives, (credentialing, appointment or invitation, disclosure and consent of patients, student participation limited)
• Participation in (Non CME) industry sponsored programs. (Discourage faculty, transparency of payment and fair market value, prohibit attendance, paying for attendance, accepting personal gifts)
• Industry Sponsored Scholarships and other Educational Funds for Trainees (Giving Centrally, no Quid pro quo, selection sole responsibility of the university)
• Food (only for ACCME-Accredited Events)
• Travel (only for legitimate reimbursement or contractual services.
• Ghostwriting (transparency of all involved in the process)
• Purchasing (Disclosure of interest, and recuse from purchasing decisions in COI cases)
• Boards of Directors, Advisory Boards and Consulting (Valuable and Compensation to Reflect Fair Market Value)

All the news that's fit to print?

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PLoS ... or Minus

04/27/2008 05:55 PM |

Important, fascinating, discouraging, and urgent new government-sponsored study (courtesy of Harvard) shows that life expectancy actually declined in a substantial number of US counties from 1983 to 1999, particularly for women. Most of the counties with declines are in the Deep South, along the Mississippi River, and in Appalachia, as well as in the southern Plains and Texas.

The study, published in the journal PLoS Medicine, concluded that the progress made in reducing deaths from cardiovascular disease, thanks to new drugs, procedures and prevention, began to level off in those years. Those gains, as they shrank, were outpaced by rising mortality from lung cancer, chronic obstructive pulmonary disease and diabetes. Smoking, which peaked for women later than for men, is thought to be a major contributor, along with obesity and hypertension.

Some, like former Senator John Edwards, are using the study to further fan the class warfare flames.  And socio-economic conditions are certainly an important part of this issue but, as Sam B. Harper, an epidemiologist at McGill University who has studied the issue commented, “We know from hundreds of studies that income does have an impact on health, but it’s not a simple relationship."

Indeed.  But politicians -- and especially frustrated ones like Senator Edwards, are always looking for simplistic, talking point-friendly answers to complicated problems.

According to  one of the report's authors, Dr. Majid Ezzati, "... life expectancy disparities would have to be addressed through public health strategies directed at reducing the risk factors that cause chronic disease and injuries."

And that means a more deliberate effort at patient-based care -- focusing on earlier diagnosis (and better diagnostics) and more targeted health care (right treatment for the right patient at the right time).  What it does not mean is a knee-jerk move towards "European" style healthcare and the ensuing cost-based rationing that inevitably comes with it.

For more detail on the study, click here: www.nytimes.com/2008/04/27/weekinreview/27sack.html

We mustn't allow the next generation of Americans to be the first in our nation's history to enjoy a shorter life than their parents.  And to achieve that goal we must abandon the rhetoric of  divisiveness and work together (government, academia, and industry) towards this common purpose.
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Phase Fore!

04/25/2008 08:47 AM |

Steve Walker of the Abigail Alliance weighs in on the issue of timely commencement of promised Phase IV trials:

"I think in some cases you are probably right about the failure to conduct Phase IV studies being a "self-inflicted" wound, but there is perhaps a bigger problem in the design of a lot of the studies.  Once a drug is approved and deemed safe and effective (in many cases proven in compelling fashion despite the absence of a perfect p-value), conducting randomized studies where patients are randomized into treatment arms that do not serve their best medical interests is fraught with all kinds of ethical and practical problems, and challenges for sponsors, physicians and doctors.  Coupled with the undeniable fact that after approval the development and learning process about many drugs accelerates dramatically (a good thing that usually leaves the slow-moving FDA far behind) often causes the trials mandated by FDA to become obsolete before they start, and even more commonly before they are completed.  When that occurs, the FDA's and other's mandates that the trials be conducted anyway degenerates into nothing but a form over substance pursuit of compliance for no other purpose than compliance.  That should not be the purpose of the regulation of medical products because it is harmful to the public health, not to mention a waste of money and patients.   Read More & Comment...

Bayh-Bayh To Another Barrier to Euro-Innovation

04/24/2008 06:13 PM |

From our friends at www.Fastercures.org...It looks as though Europe is tearing down another anti-capitalist wall: the one between academia and industry that slowed translation of biotechnology into products.  How?  By using the same approach that President Reagan took by expanding the Bayh-Dole through executive order with Federal Technology Transfer Act.  That put government agencies on notice to share all patentable technologies with the private sector to promote investment al presto. 

This will make the pharmaceutical purists and conflict of interest capos sick am I sure.  There is now nowhere in the world where their views have been turned into policy or law...except North Korea or Cuba.   Here's the post from Fastercures Smartbrief...

EC wants more research headed to product development
The European Commission is asking for more interaction between universities and pharmaceutical companies to ensure that research knowledge is more quickly translated into products and services. The EC adopted a recommendation on how member states can revise their policies to allow public research organizations to leverage intellectual property more effectively. In-PharmaTechnologist.com  Read More & Comment...

Wood That Everyone Had Same Sane Views on the FDA

04/24/2008 05:33 PM |

Alastair Wood's excellent editorial in the NEJM, rising above the hysterics with wit and intellect:

content.nejm.org/cgi/content/full/358/17/1774  Read More & Comment...

Study Buddies

04/24/2008 09:27 AM |

According to Bloomberg (the news service not the mayor):

“Drugmakers haven't made progress in starting studies that they promised to conduct after their products were approved by U.S. regulators. The Food and Drug Administration determined that 1,044, or 62 percent, of incomplete studies for conventional drugs and biotechnology medications had yet to be started as of Sept. 30. At the same time in 2006, 1,026, or 63 percent, of the unfinished studies hadn't begun, according to the FDA.”

Here's a link to the complete story:

www.bloomberg.com/apps/news

Yes, I know, it’s not that simple – but that being said, it’s true.  And that has to change.  While this issue does play into the hands of the usual suspect safety jihadists (note quote in article by Peter Lurie) – promised studies should be commenced promptly.

Yes, there are many relevant and extenuating circumstances (note quote from PhRMA), but, as far as industry is concerned, this is a self-inflicted wound that spin cannot fix.


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EU Considers Merging onto the Healthcare Information Superhighway

04/24/2008 07:54 AM |

Maybe it has something to do with the strength of the Euro -- or maybe it has something to do with a patient's right to know.  And just maybe things are beginning to change.

Have a look at this new article (from the Journal of Life Sciences) on how the EU is pondering changing what's allowable vis-a-vis what they call "Information to Patients" and we in the US call "Direct to Consumer Communications:

www.tjols.com/article-640.html

Bottom line -- knowledge is power.

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Gene -- but not heard

04/23/2008 08:05 PM |

Finally we are going to settle the issue of genetic testing and personal privacy.  And it's about time. 

According to Andy Pollack's story in today's New York Times:

"Proponents say the new law, more than a dozen years in the making, would help usher in an age of genetic medicine, in which DNA tests might help predict if a person is at risk of a disease, allowing action to be taken to prevent it.

Some of the tests already exist, like one for breast cancer risk, and new ones are being introduced almost every month. But backers of the legislation say many people are afraid of taking such tests because they fear the results would be used to deny them employment or health insurance.

“This bill removes a significant obstacle to the advancement of personalized medicine,” said Edward Abrahams, the executive director of the Personalized Medicine Coalition. His group is an organization of drug and diagnostic companies, academic institutions and patient groups that advocate using genetic information to choose the most appropriate treatment for each patient."

Here's the rest of the story:

www.nytimes.com/2008/04/23/business/23gene.html

All sounds good, right?  Hopefully. 

We'll wait and see, when the payer is the government , if Uncle Sam retains the same "keep your hands outta my genes" philosophy.

But, in the meantime, well done.
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Heparin Hypocrisy - Hyped Up Safety Fears on ADHD Drugs -Does Medicaid Kill Poor People

04/23/2008 07:17 PM |

Yet another show trial held by another congressional committee on the FDA...There have been four or five over the last two months on heparin alone. Andy von Eschenbach, who is gaining momentum, along with the FDA, in shifting the agency towards a science and systems based approach to regulation -- using real time technology to promote full time compliance -- has to sit and take the following from the likes of Bart Stupak (D-Michigan):

"Last year, this nation's regulatory failures resulted in dead dogs and cats. This year, it has tragically led to the deaths of people," said Rep. Bart Stupak, D-Mich. "If we don't make some rapid progress on fixing the foreign drug inspection program, the next melamine or heparin tragedy will soon be upon us."

That's rich coming from a guy who helped push up the suicide rates by scaring parents away from antidepressants. and who is pushing for drug importation at a time when Al Qaeda and Hezbollah are involved in drug counterfeiting....Andy must have to shower after sitting through such a show trial...

www.fraudaid.com/scamspeak/conprods.htm

Meanwhile the Steve Nissen fear factory spews out another piece of tabloid medicine: EKG monitoring of all kids getting stimulants for ADHD.. Now there's a way to achieve Nissen (who has never studied ADHD) goal of making a physician's hand quiver before writing a scrip for the drug....But will it improve prescribing? Ron Winslow of the WSJ nails it:

"Since 1999, fewer than 30 sudden deaths among children have been linked to the drugs, which are currently taken by more than 2.5 million youngsters in the U.S. Issues of cost, available expertise in reading children's ECGs and concern about false-positive tests are prompting some experts to question the rationale for urging an ECG in particular.

"This is a $250 million recommendation," says Mike Ackerman, a pediatric cardiologist at the Mayo Clinic in Rochester, Minn., who estimates the total cost of an ECG at about $100. "We're really trying to find a needle in a haystack, and we have no data yet to know that the screening program they're recommending would capture" those few at-risk individuals. Dr. Ackerman was a member of another American Heart Association panel that last year stopped short of recommending routine ECG screening for heart abnormalities in young competitive athletes."

Read the Wall Street Journal article

FInally a pattern appears to emerging that has escaped even the great John Wennberg: the life expectancy of poor people is declining even as that of others is increasing. Women in particular are dying earlier than men in rural areas. Can we say Medicaid and SCHIP anyone? And I should note that Frank Lichtenberg spotted a decline in life expectancy among the elderly in the VA, the same VA that Shannon Brownlee -- Wennberg's Boswell -- is pushing as the example of what we all should be forced into in the Dartmouth comparative effectiveness utopia. Eeech...

Here's the article by the ever wonderful Maggie Fox of Reuters with a link to the study which is pretty methodologically sound:

www.reuters.com/article/scienceNews/idUSN2146521720080422  Read More & Comment...