Following Cato's Twisted Logic....Why Not Reimport Gasoline....

05/08/2007 07:29 AM |

Roger Pilon's Cato Institute still believes that using protectionist policies from other nation's is perfectly consistent with free market libertarian principles...maybe he can make the case for reinporting gasoline from the Saudis at highly subsidized prices to lower gas prices here.

http://biz.yahoo.com/cnnm/070504/050407_gas_demand.html?.v=1&.pf=family-home  Read More & Comment...

Bleak House 2007

05/07/2007 10:29 AM |

For those pols and pundits who think that we need a health care system "just like Europe," some harsh reality from the other side of the Pond.

The Observer (one of the leading liberal-left newspapers in Europe) reports that British doctors will take the historic step of admitting for the first time that many health treatments will be rationed in the future because the NHS cannot cope with spiraling demand from patients.

In a major report, the British Medical Association will warn that patients face a bleak future because they will increasingly be denied treatments. The BMA will urge the NHS to be much more explicit about what it can realistically afford to do and ask political leaders to engage in an open, honest debate about rationing.

Dr Michael Wilks, one of the BMA's senior office holders, revealed the organization’s radical thinking in a recent letter to its 139,000 members updating them on the progress of the BMA working group. He told them the group had concluded that '"while the service should remain universal, the challenges raise questions about how comprehensive the service can continue to be. This will depend on whether politicians and the taxpayer are prepared to contemplate either increasing expenditure or explicit rationing."

Here's a link to the Observer article:

http://observer.guardian.co.uk/uk_news/story/0,,2073633,00.html

Additional recommended reading includes Stephen Pollard's comments which can be found at http://cnehealth.org/  Read More & Comment...

Barack takes a BIO Break

05/07/2007 09:34 AM |

As BIO kicks off in Boston, so too does a new magazine, The Journal of Life Sciences. Check out the website at http://www.tjols.com.

Today the site features a commentary by Barack Obama. Here are a few select paragraphs ...

"We know that all human beings are 99.9 percent identical in genetic makeup, but differences in the remaining 0.1 percent hold important clues about the causes of disease and response to drugs. Simply put, the study of genomics will help us learn why some people get sick and others do not, and use this information to better prevent and treat disease."

"The relatively new field of genomics is key to the practice of personalized medicine. Personalized medicine is the use of genomic and molecular data to better target the delivery of health care, facilitate the discovery and clinical testing of new products, and help determine a patient’s predisposition to a particular disease or condition."

"Personalized medicine represents a revolutionary and exciting change in the fundamental approach and practice of medicine."

"Realizing the promise of personalized medicine will require continued federal leadership and agency collaboration; expansion and acceleration of genomics research; a capable genomics workforce; incentives to encourage development of genomic tests and therapies; and greater attention to the quality of genetic tests, direct-to-consumer advertising and use of personal genomic information."

Here's a link to the entire piece:

http://www.tjols.com/web_new_frontier.jsp

If the Senator keeps this up, we may have to invite him to join our organization.  Read More & Comment...

And ALLHAT Jazz

05/07/2007 09:01 AM |

Recently Congress considered adding cost-effectiveness as a criterion for selecting and paying for medicines under Medicare.

This model (variously called “evidence-based medicine,” “healthcare technology assessment,” or "comparative effectiveness”) relies heavily on findings from randomized clinical trials. While these trials are essential to demonstrating the safety and efficacy of new medical products, the results are based on large population averages that rarely if ever will tell us which treatments are “best” for which patients. That is why it is so critically important for the physician to maintain his or her ability to combine study findings with their expertise and knowledge of the individual in order to make the optimal treatment decisions.

Government sponsored studies that conduct head-to-head comparisons of drugs in "real world’"clinical settings are regarded as a valuable source of information for such coverage and reimbursement decisions -- if not for making clinical decisions. Two such studies, the Clinical Antipsychotic Trials in Intervention Effectiveness or CATIE study and the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) were two such “practice based” clinical trials, sponsored in part by the National Institutes of Health, to determine whether older medicines were as effective in achieving certain clinical outcomes as newer ones.

While media reports and the government agencies that sponsored the studies claimed that “older and cheaper” were equally effective, these conclusions were not without critics or controversy.

The Center for Medicine in the Public Interest held a day long conference on Media, Medicine and the Public Interest in Washington DC on January 26, 2007 that included an expert panel on the conduct and implications of CATIE and ALLHAT.

And when we say "expert" we mean "expert." Panelists included Hebert Meltzer, MD who helped to design CATIE, Michael Weber, MD, similarly involved with ALLHAT, Dr. Susan Horn of the Institute for Clinical Outcomes Research, Dr. David Shern, President and CEO of the National Mental Health Association, Ralph Snyderman, MD of Duke University, and Matt Herper of Forbes.

The panel was chaired by Kate Rawson, senior editor of th RPM Report, who also edited the panel transcripts.

Here is a link to the paper, ALLHAT and CATIE Reconsidered: Reflections on Big Studies and Evidence Based Medicine as the Measure of Comparative Effectiveness.

Download file

Thoughts and comments most welcome.  Read More & Comment...

whatever happened to zelnorm

05/04/2007 07:52 PM |

my column in M,M & M just out - with a fresh look at the scalded IBS drug -

For many patients suffering from Irritable Bowel Syndrome (IBS) with severe
constipation, Novartis¹ Zelnorm was a miracle treatment. But the current
focus on negative aspects of the drug has placed an unfortunate cloud over
its use.
What happened? A total of 29 placebo-controlled, 1-3 month trials of more
than 11,600 patients receiving Zelnorm showed a slight increase in the risk
of cardiovascular events‹angina, heart attacks and strokes‹over placebo
(0.1% versus 0.01%).
But these studies‹for the most part‹involved patients in higher risk groups
than those for whom myself and
others would prescribe it, and for some also a longer use
of the drug. Plus, many physicians were already aware of this potential
problem, which was why we gave the drug
mainly to younger people with lower risk for cardiovascular events.
The Food and Drug Administration acted quickly in its public advisory and
Novartis has agreed to stop marketing the drug and selling it in the US.
This is certainly a responsible and cautious reaction. So why aren¹t the FDA
and Novartis being praised for their actions on behalf of drug safety?
The answer is that we currently live in an unhealthy climate of drug company
bashing where every newly demonstrated risk is an opportunity for a new
round of criticism. Those who engage in this habit tend to justify it as a
way to protect society, though there is certainly a tradeoff‹excess caution
and fear of attack is certainly not conducive to research and development,
so don¹t be surprised if drug discoveries continue to decline.
It makes sense to keep Zelnorm in reserve for those in lower risk groups who
really need it. It also makes sense to not inflame the news of its slight
increased risk of heart disease and stroke and use it as a pulpit to start
criticizing everyone in sight.  Read More & Comment...

Dorgan's Double Standard

05/04/2007 08:59 AM |

From the Washington Times: "Mr. Dorgan's bill would implement an approval standard for foreign-made drugs in which the manufacturer notifies the FDA of differences between the drug and the corresponding U.S. label. "

Would Mr. Dorgan accept that as an approval standard for imported food as well?  Read More & Comment...

Rocky's Racoon

05/04/2007 08:06 AM |

Per Senator Rockefeller's opinion that we need to legislate branded generics out of existence, we are once again faced with the immutable Theory of Medicare Relativism — when politics wins, patients lose.

If the honorable gentleman gets his way, the category of medicines known as “authorized generics” (also referred to as “branded generics”) will vanish — and drug prices for millions of Americans could go up by as much as 17%. (This calculation is based on a comparison of what consumers actually spent on generics during the 180-day exclusivity period to what they would have spent to purchase the same quantity of generics at higher prices in the absence of a branded generic launch.)

The deliverable to the American patient? Higher prices and fewer choices. Needless to say, Rocky's “modest proposal” is being greedily embraced by the generics industry and Big Pharma bashers. And greedy is hardly hyperbole since profits on generic medicines exceed 45% even when there is a competitive branded generic on the market.

This is what we get for Medicare modernization? It’s Voltaire’s famous aphorism come to life, “The art of medicine consists in amusing the patient while nature cures the disease.” It would be far better if Senator Rockefeller followed the advice of Professor Einstein who said, “Any intelligent fool can make things bigger, more complex, and more violent. It takes a touch of genius — and a lot of courage — to move in the opposite direction.”

Here's a link to a new study providing more data:

http://www.genengnews.com/news/bnitem.aspx?name=16644361

It's either the facts or Rocky's Horror Picture Show.  Read More & Comment...

Mania vs. Measure

05/04/2007 07:13 AM |

In recent weeks, several state legislatures have been working feverishly to remove perceived potential conflicts of interest between doctors and pharmaceutical companies. Citing transparency as their goal, state lawmakers in Vermont, Minnesota, New York and elsewhere have passed “marketing-disclosure” laws that require drug companies to divulge all payments made to doctors.

These directives have arisen amid accusations that drug manufacturers have usurped the FDA process, essentially paying doctors to get their drugs on the market before a drug’s safety can be guaranteed.

Imagine if the scientific community had ignored Louis Pasteur’s research on bacteria and fermentation simply because he had received funding from the wine industry. Science would have been set back immeasurably, and you might not be able to buy safe, pasteurized milk in your local supermarket today. Talk about food safety!

The rest of the story can be found at http://www.projo.com under "Opinion." (It's the Providence Journal.)

Have a nice weekend.  Read More & Comment...

A New Deputy in Town (at HHS)...and a new CMS Director

05/03/2007 03:43 PM |

The President intends to nominate Tevi David Troy, of New York, to be Deputy Secretary of Health and Human Services. Dr. Troy currently serves as Deputy Assistant to the President for Domestic Policy. Prior to this, he served as Special Assistant to the President and Deputy Cabinet Secretary. Earlier in his career, he served as Deputy Assistant Secretary for Policy at the Department of Labor. Dr. Troy received his bachelor’s degree from Cornell University and his master’s degree and PhD from The University of Texas at Austin.

Anyone who knows Tevi knows that HHS has gained a great public servant and staunch Yankee fan.

Kerry Weems replaces Leslie Norwalk as CMS Administrator.  Read More & Comment...

The Global View of FDA Reform

05/03/2007 09:11 AM |

Biotech entrepreneuers from India, China, Brazil don't talk about breaking patents, price controls, hating big Pharma...none of the junk that fills the time and effort of the NGOs whose efforts among to -- in the words of one participant "a rounding error" in the war against disease. Rather, it is all about partnerships, raising capital, IP protection and most important...harmonization of regulatory standards with the FDA's Critical Path efforts.

I cannot tell you what excitement the Critical Path effort has stirred among many of the start ups here. The idea of shortening development times, micro-dosings, using biomarkers for toxicity studies, being able to submit a single application to a single standard is the single most important barrier to the development of products for unmet global health needs. Note to the FDA, the Critical Path needs to go global to rev up the global health revolution. Companies overseas DO want to import medicines to the US, but ONLY if they are safe, effective and valuable.  Read More & Comment...

Smart, Timely, Urgent FDA Reform

05/03/2007 06:30 AM |

Our view on the Senate debate over FDA reform: "Bolster medicine safety"

Thoughts and comments most welcome. Now's the time to make a difference.  Read More & Comment...

How about generic drugs from Canada?

05/02/2007 04:41 PM |

New Critical Path Report Highlights Research Needed to Foster Generic Drug Development

The U.S. Food and Drug Administration (FDA) today issued the "Critical Path Opportunities for Generic Drugs" report identifying many of the unanswered scientific questions that impede the development of generic versions of commonly used drugs.

The report is part of FDA's Critical Path Initiative, established in 2004 to discern what challenges exist in moving a promising drug, biologic or device along the critical path from discovery, or proof of concept, to a marketable product. Solving these challenges will require the expertise and input of many groups, including scientists from universities, patient groups, government, industry, associations and other private organizations.

"This report pinpoints the barriers that are limiting the availability of additional generic drug options," said Gary Buehler, R.Ph., director, FDA's Office of Generic Drugs. "We hope these findings will encourage research collaboration, lower these barriers and accelerate access to safe and effective generic drugs."

Before they can be approved, generic drugs must have the same active ingredient, dosage form, strength, and conditions of use as the brand name drug. The drugs must also be absorbed at the same rate and in the same amount, a concept known as bioequivalence.

While straightforward tests of blood plasma levels are sufficient to demonstrate bioequivalence for most generic drug candidates, these common tests generally are not appropriate for certain drugs, including asthma inhalers, nasal sprays, and topical skin applications such as anti-fungal creams. As a result, few generic versions are available in these product categories, resulting in less competition and higher prices.

For example, generic drug products that contain the ozone-depleting substance chlorofluorocarbon will be withdrawn from the market after 2008. The new report will help ensure FDA has an adequate scientific basis to review inhaler applications that use an alternative, hydrofluoroalkane.

The report also calls for research on new bioequivalence methods tailor-made for each challenging drug class. These include lung function tests and molecular level imaging for inhalation drugs; particle size distribution tests for nasal sprays; and methods for direct measurement of drug delivered to the skin.

In addition, the report highlights possible research projects that might lead to new modeling and simulation tools for drug absorption, drug release and other drug development issues and to alternative methods for seeking waivers from clinical bioequivalence studies.

Last year FDA issued the Critical Path Opportunities Report listing 76 specific scientific projects that, if undertaken, would help modernize the Critical Path sciences. This companion document focuses more narrowly on the scientific challenges unique to the development of generic drugs.  Read More & Comment...

Dorgan Organ III

05/02/2007 01:48 PM |

Important to point out that the Dorgan Amendment would allow importation from Canada, Switzerland, New Zealand, Australia, Japan.

And the EU -- "but does not include a member country with respect to which the country's Annex to the Treaty of Accession to the European Union 2003 includes a transitional measure for the regulation of human pharmaceutical products that has not expired."

Nice try. Parallel trade makes the entire EU a free trade zone when it comes to pharmaceuticals. Consider the over 20% of drugs sold in Great Britain that originate in other, lower cost parts of Europe like Greece and Portugal, Latvia and Estonia.

Senator Flickertail's amendment also demands that approved nations "have statutory or regulatory requirements that require the review of drugs for safety and effectiveness by an entity of the government of the country."

Folks, "requirements" can mean a lot of things from nation to nation. What actually happens can be something altogether different.  Read More & Comment...

heart attack death rate

05/02/2007 12:06 PM |

it is hardly suprising to those of us who have watched cardiovascular advances up close in the clinical trenches to find out that the hospital death rate from heart attack or the incidence of severe heart failure is down by almost half. And though we should applaud this affirmation, we shouldn't be derailed from a larger point that death rate is not the only issue. We have known for a long time that patients feel better after angioplasties and stents, and we have seen the medications work to relieve symptoms and stabilize patients. It isn't just a question of survival - it's also a question of survive how? It may be a subtle point, but if we applaud the lower death rate statistic too much, it may undermine the point that this isn't the only criteria for gauging medical success, even if it is an easy thing to measure.  Read More & Comment...

Patents, Patience, Profits & Public Health

05/02/2007 10:07 AM |

Further thoughts on the recent Supreme Court decision on patents, "obvious" innovation, and incremental innovation.

According to the Center for the Study of Drug Development at Tufts University, only 1 in every 5,000 compounds screened becomes an approved medicine. This means of every 5,000-10,000 compounds tested, only 250 enter pre-clinical testing, five into clinical testing and only one achieves FDA approval. Without financial incentives and intellectual property protection, no company, even ones with the most benevolent motivations, would find it feasible to develop new, innovative, lifesaving and life enhancing-products for consumers.

Allowing the private sector to bear both the risk and the reward for successfully developing pharmaceutical, biologic, and medical device products has been and remains the most successful and efficient way to meet our public health goals

Competition among companies, both here in the U.S and abroad, assures a diversity of expertise in various diseases. This competitive model assures that, when a public health crisis is identified, there will be an available pool of talent, experience, and infrastructure to give us enhanced opportunities to successfully identify and produce cures and vaccines in an expedited timeframe.

"Obvious?" Hopefully.  Read More & Comment...

Dorgan Organ II

05/02/2007 09:28 AM |

Flickertail Senator Byron Dorgan continues to pursue his unworkable, unsafe, unwise and, well, just plain foolish amendment on drug importation.

What he should do is spend a few minutes on the FDA website, where he would find this new safety alert ...

FDA Warns Consumers about Counterfeit Drugs from Multiple Internet Sellers

The Food and Drug Administration (FDA) is cautioning U.S. consumers about dangers associated with buying prescription drugs over the Internet. This alert is being issued based on information the agency received showing that 24 apparently related Web sites may be involved in the distribution of counterfeit prescription drugs.

On three occasions during recent months, FDA received information that counterfeit versions of Xenical 120 mg capsules, a drug manufactured by Hoffmann-La Roche Inc. (Roche), were obtained by three consumers from two different Web sites. Xenical is an FDA-approved drug used to help obese individuals who meet certain weight and height requirements lose weight and maintain weight loss.

None of the capsules ordered off the Web sites contained orlistat, the active ingredient in authentic Xenical. In fact, laboratory analysis conducted by Roche and submitted to the FDA confirmed that one capsule contained sibutramine, which is the active ingredient in Meridia, an FDA-approved prescription drug manufactured by Abbott Laboratories.

While this product is also used to help people lose weight and maintain that loss, it should not be used in certain patient populations and therefore is not a substitute for other weight loss products. In addition the drug interactions profile is different between Xenical and sibutramine, as is the dosing frequency; sibutramine is administered once daily while Xenical is dosed three times a day.

Other samples of drug product obtained from two of the Internet orders were composed of only talc and starch. According to Roche, these two samples displayed a valid Roche lot number of B2306 and were labeled with an expiration date of April 2007. The correct expiration date for this lot number is actually March 2005. Pictures of the counterfeit Xenical capsules provided by Roche can be viewed at http://www.fda.gov/bbs/topics/news/photos/xenical/html

Roche identified the two Web sites involved in this incident as brandpills.com and pillspharm.com. Further investigation by FDA disclosed that these Web sites are two of 24 Web sites that appear on the pharmacycall365.com home page under the "Our Websites" heading. Four of these Web sites previously have been identified by FDA's Office of Criminal Investigations as being associated with the distribution of counterfeit Tamiflu and counterfeit Cialis.

At this point, it appears that these Web sites are operated from outside of the United States. Consumers should be wary, if there is no way to contact the Web site pharmacy by phone, if prices are dramatically lower than the competition, or if no prescription from your doctor is required. As a result, FDA strongly cautions consumers about purchasing drugs from any of these Web sites which may be involved in the distribution of counterfeit drugs and reiterates previous public warnings about buying prescription drugs online.

Senator Flickertail -- you can't be for safety and against it at the same time.  Read More & Comment...

I Guess All Those Industry Sponsored Studies Were Right ...

05/02/2007 08:40 AM |

As Peter points out below, a new study shows that all those people who are taking medicines based on research conducted by researchers corrupted by Big Pharma about the drugs developed by Big Pharma based on clinical trials skewed by Big Pharma and it's cozy relationship with the FDA are not dying from heart attacks as often as before.

But maybe the study is skewed.

Or as Groucho Marx said: "Either this man is dead or my watch has stopped ticking."  Read More & Comment...

Wow! Indeed

05/02/2007 08:10 AM |

Got an e-mail this morning with a one word subject line, "Wow!"

And "wow" it was. And "wow" it is.

In just six years, death rates and heart failure in hospitalized heart attack patients have fallen sharply, most likely because of better treatment, the largest international study of its kind suggests.

The promising trend parallels the growing use of cholesterol-lowering drugs, powerful blood thinners, and angioplasty, the procedure that opens clogged arteries, the researchers said.

“These results are really dramatic, because, in fact, they’re the first time anybody has demonstrated a reduction in the development of new heart failure,” said lead author Dr. Keith Fox, a cardiology professor at the University of Edinburgh.

The six-year study involved nearly 45,000 patients in 14 countries who had major heart attacks or dangerous partial artery blockages. The percentage of patients who died in the hospital or who developed heart failure was nearly cut in half from 1999 to 2005.

And the heart attack patients treated most recently were far less likely to have another attack within six months of being hospitalized when compared to the patients treated six years earlier -- a sign that the more aggressive efforts of doctors in the last few years are working. There have been other signs that better treatment of heart patients has been saving lives, but not on a scale as large as this international study, the researchers said.

“It’s much more dramatic than we expected, in the course of six years,” Fox said.

The study appears in Wednesday’s Journal of the American Medical Association. It was funded by a grant from Sanofi-Aventis, maker of several heart drugs including Plavix and ACE inhibitors. Fox and several other authors reported getting fees and grants from Sanofi and other drug makers.

Dr. Steven Nissen, former president of the American College of Cardiology and a Cleveland Clinic heart specialist, said the study doesn’t prove the recommended treatments were saving lives but he suspects that’s the case.

“I really am encouraged that those things that appear in our guidelines are being used by physicians around the world,” Nissen said.

Here's a link to a more complete report:

http://www.msnbc.msn.com/id/18417962/from/ET/

And, for your chuckle of the morning, remember the words of Robert Bloch,

"I have the heart of a child. I keep it in a jar on my shelf."  Read More & Comment...

Taking NGO Rhetoric With a Grain of Salt

05/02/2007 08:02 AM |

Blogging from the conference on Mobilizing the Private Sector of Global Health Development....C.K. Prahalad, Prof. University of Michigan drops a bombshell at the beginning. " We can save the lives of millions of children in India if we increase the consumption of iodized salt instead and improving health care delivery systems in small ways through small steps with the private sector rather than focusing on making breakthrough medicines affordable. " Using market systems, we can make anti-bacterial salt, iodized salt, water available and affordable and achieve a huge return on health care dollars to obtain a greater quality of life. Innovation in distribution, education, collaboration is perhaps more important. There is a $5 trillion market comprised of people living on less than $3000 per capita using these products. Pharmaceuticals make up about $100 billion (have to check that since I am writing so fast!) Moreover, the poor are upwardly mobile and willing to adopt technologies, they are not Luddites. They can make complex decisions. The poor are NOT too stupid to choose as liberals would believe.

Also: "All those free medicines are not so free. When people go to those public clinics they have to pay for them. Let's be honest. That's an unspoken truth."

I wonder what MSF, Oxfam, etc would say to that?  Read More & Comment...

Tainted Pet Food: Not Just Chicken Feed

05/02/2007 06:13 AM |

Has anyone drawn the connection between tainted pet food and counterfeit drugs? Anyone? Anyone? There has got to be a quote from Sens. Dorgan, Stabenow, etc.. and all those from the ag states denouncing the FDA for lax inspection...the same bunch who assure us the agency can fan out across the globe monitoring all the various distributors and wholesalers or can assure safety by just inspecting their papers. I mean, after all, no one died from the pet food scandal, right? As Bernie Sanders would say, show us the dead bodies.  Read More & Comment...