IMI Shelter

12/21/2007 04:08 AM |

What does the European Commission know that Rosa DeLauro does not?

According to the Financial Times ...

The European Commission is poised to agree a groundbreaking €2bn ($2.9bn, £1.5bn) partnership with the pharmaceutical industry this week designed to win back Europe's place as a centre for global medical innovation.

The Innovative Medicines Initiative, financed equally by the industry and the Commission, will support research by academic and industry groups over seven years designed to speed up the predictable testing of the safety and efficacy of medicines. The move, part of the EU's "Lisbon agenda" to regain competitiveness, aims to boost collaboration between commercial companies, universities and regulators to more rapidly develop "pre-competitive" tests and accelerate the launch of innovative drugs.  Read More & Comment...

The Udder Side of the Story

12/20/2007 09:07 AM |

The Baltimore Sun reports that, “A long-running clash over the marketing of meat and milk from cloned animals is coming to a head in Washington as the government prepares to make a ruling that would allow the products to be sold to consumers for the first time.

Critics in Congress, including Sen. Barbara A. Mikulski of Maryland, are attempting to delay the action expected from the Food and Drug Administration, which could decide as early as this week to permit sales. These opponents are rushing to gain approval by Congress this week of a provision that would encourage the FDA to delay action until further studies are completed.”

Here’s the complete story:

http://www.baltimoresun.com/news/health/bal-te.clone19dec19,0,6919236.story

According to the FDA, the agency has "studies that show that the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals." In other words –GRAS.

Does this mean cloned beef in your burger? No. At tens of thousands of dollars per “founder” clone this is hardly likely (at least in the foreseeable future). So, unless you’re in the market for a $25,000 Big Mac, relax.

You want fries with that?

In the future, if and when the technology for animal cloning becomes more cost-efficient, it is possible that the meat of clone progeny could be available at retail. And milk from clones is certainly on the way a lot sooner.

By promulgating this new rule, FDA is working to advance the science of cloning -- an important advance towards creating a better, safer 21st century food supply.

Dairy producers are worried about what might happen if "clone-free" products start showing up in supermarkets. "We have concerns where people are going to try to draw distinctions and differences where none exist," said Chris Galen, spokesman for the National Milk Producers Federation.

It's a contentious topic – but the fact is that the agency has been studying this issue in great detail for a very long period of time. In fact, many of the world's leading experts on this issue work at the FDA's Center for Veterinary Medicine. During my tenure at the FDA (which ended in 2004), this issue was already being deeply investigated and intensely debated. So, when people accuse the agency' of reaching a decision without either due regulatory process or focus on science, I say, where's the beef?  Read More & Comment...

Oysters Anyone?

12/19/2007 04:50 PM |

Appropriations agriculture subcommittee chairwoman Rosa DeLauro has no problem cutting funding to promote the Critical Path initiative. Perhaps it was to make room for about $24.5 million worth of earmarks for her district. That includes about " $400,000 for Connecticut oyster fisheries. DeLauro, who is a member of the Commerce, Justice and Science Subcommittee, received $4.9 million in earmarks in one bill (Agriculture) alone, the "" including $500,000 for the Henry C. Lee Institute of Forensic Science Cold Case Center at the University of New Haven. " That's the same amount and the same bill from which she cut out money for FDA's Critical Path foundation.

Now that's leadership.

View Article
  Read More & Comment...

Sub Rosa

12/19/2007 06:35 AM |

The omnibus spending package moving through Congress would block FDA from transferring any money to the Reagan-Udall Foundation, the research institution created by the FDA Amendments Act.

The FDAAA. which implemented a slew of new policies while reauthorizing industry user fees, stipulates that FDA provide between $500,000 and $1.25 million per year to the Reagan-Udall Foundation. But the omnibus appropriations bill specifically blocks FDA from transferring any money to the foundation.

The prime mover behind this is Representative Rosa DeLauro (D-CT) (who chairs the appropriations subcommittee that funds FDA). Ms. DeLauro believes the Reagan-Udall Foundation “has the potential of endorsing the approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials.”

That is just absurd. When a senior member of Congress can blatantly accuse the FDA and the pharmaceutical industry of wanting to lower standards for drug development and review, it illustrates just how low a point we have reached. It’s just the absolute nadir. A new low in politics trumping public health.

A 21st century Scopes Monkey Trial.

He that troubleth his own house shall inherit the wind:
and the fool shall be servant to the wise of heart.

Proverbs 11:29  Read More & Comment...

VA Health Care

12/18/2007 11:50 AM |

My oped on VA health care in the Washington Times

http://washingtontimes.com/article/20071218/EDITORIAL/800572185/1013/editorial  Read More & Comment...

And a tax credit for being a vegan

12/18/2007 11:30 AM |

What's worse than a bad idea? How about a bad idea without any details.

SAN FRANCISCO (AP) -- Mayor Gavin Newsom wants large grocery stores to help fight obesity by paying fees on sodas and other beverages they sell in San Francisco.

Newsom has asked his staff to prepare a law that would charge retail chains for stocking Coke, Pepsi and other drinks sweetened with high fructose corn syrup.

Mayoral spokesman Nathan Ballard says the size of the fee and how it would be assessed still have to be worked out.

He says there's a direct link between sweet beverages and obesity, which puts added pressure on San Francisco's health care system.

If the bill is approved by the Board of Supervisors, money generated from the fee would go toward a city program that emphasizes exercise, diet and other preventative health measures.

A direct link to obesity? The only direct link is the one between calories in and calories out. That being the case, perhaps the Mayor should also consider a "sit on your tuchus tax" on the sale of flat screen televisions.

The idea to tax soda is well, flat.  Read More & Comment...

And a big "CHAI" to Theft

12/18/2007 05:11 AM |

Remember Ira Magaziner? He was one of the original architect's of HillaryCare. Today he serves as Chairman of the Clinton Foundation's HIV/AIDS Initiative -- known by the acronym CHAI. Well, what can one say other than, "To Life!"

Actually, there is something else that can be said -- like why is CHAI supporting the theft of intellectual property of pharmaceutical companies? Here's what Mr. Magaziner had to say at the recent meeting of the International Generic Pharmaceutical Alliance meeting in Miami:

"We publicly supported the Thai government and the Brazilian government when they issued compulsory licenses for AIDS drugs because we know that they are legal under TRIPS ..."

Well, actually, that's just his opinion -- others disagree quite vocally as to whether or not Thailand and Brazil acted "legally." Drugwonks certainly does not think they did.

But Ira is certainly entitled to his opinion. What makes this more interesting and important than it otherwise might be is whether this is a window into how a Hillary Clinton presidency might view intellectual property.

It would be a good question to ask Senator Clinton during the next debate.  Read More & Comment...

Fake Drug Zones and Free Trade

12/17/2007 01:26 PM |

How Free Trade Zones, where products are repackaged and redistributed and deregulated conditions, promote and encourage counterfeit drugs. All those libertarians who equate free trade with drug importation were right all along...


http://www.blueridgenow.com/article/20071217/ZNYT02/712170342/1171/AP/ZNYT02/Free_Trade_Zones_Ease_Passage_of_Counterfeit_Drugs

And as an added bonus...an article from the Financial Times dealing with how lackluster the Brits inspection of reimported drugs are, which in turn gives drug counterfeiter, crime organizations and terrorists a gaping hole from which to ship their fakes to...you guessed it, the USA. Meanwhile Congress continues to push for drug importation. And you wonder why we were not able to connect the dots before 9-11??

http://www.ft.com/cms/s/0/ad28168c-9951-11dc-bb45-0000779fd2ac.html  Read More & Comment...

L'Etat, C'est moins NICE

12/17/2007 11:30 AM |

In September I participated in a conference of French health care regulators, pharmaceutical firms and members of the Assemblée Nationale. The keynote of the event was a speech by the French Minister of Health, Madame Roselyne Bachelot. She gave a thoughtful presentation on the need for all concerned to work together for the public good.

Recently she showed that she meant what she said with these comments in front of the French Parliament:

"Je suis enfin défavorable à ce que l'on intègre,à l'instar du NICE, la notion de quality-adjusting life-years dans les indicateurs d'éfficience médico-économique. Cela ne correspond pas à la culture dont la HAS doit s'inspirer."

For those of you who took Spanish in high school, here's the translation:

"I am not in favor, as it is done by NICE, to integrate the notion of quality-adjusting life-years among the indicators for medico-economic efficiency. It does not correspond to the culture which should inspire the HAS."

(HAS = La Haute Autorité de Santé. HAS roughly corresponds to NICE in the UK or CMS in the US -- not precisely, but you get the idea.)

Well, amen to French culture and a big "Bon Courage!" to Madame Bachelot.  Read More & Comment...

Kessler's Exit Raises Questions About Medicine As Profession

12/17/2007 10:28 AM |

David Kessler was fired as dean of Univ of California SanFran Medical School. I have no love for Kessler's reign as FDA commissioner -- at least when Clinton was prez and the Dems controlled Congress. Kessler left the FDA to become dean of Yale medical school where most everyone agreed he did a great job. He took on the UCSF job because it is supposed be a world leader in translational medicine, that is, a powerhouse in doing the sort of work that drug companies are supposed to do and don't according to the Soros funded types.

But Kessler found that UCSF, instead of having about $70 million to build up the integrated translational programs he came to establish was deep in the financial toilet. His efforts to clean things up lead to a slimy charge that he was pocketing dough, a charge that was baseless.

Kessler is stepping down. But his inability to institute changes to make the medical school financially accountable raises troubling questions about the ability of the academic medical institutions to properly oversee clinical trials, drug development, practice guidelines, etc. Academic institutions are less transparent and less accountable than most entities. And now we see with UCSF and other universities financial irregularities if not outright corruption as a result of direct manipulation by politicians. I am thinking specifically of the University of Medicine and Dentistry of NJ where the med school's political overseers have nearly ran that fine institution into the ground with self dealing and indifference.

We now see that Congress has no problem calling members of FDA advisory committees if they don't like a particular decision. Imagine how academics would buckle if their every study was under congressional scrutiny. This is how science should be conducted? This is new order the Reformers would impose on us? The Kessler departure raises serious questions about the ability of academic institutions to handle the serious responsibility of transforming scientific insights into preventive and proactive treatments. They cannot be trusted or asked to do so. And neither can the arrogant leaders of the Hate Pharma movement who have tried to seize the dollars and power to determine the course of medicine for themselves and cronies.

http://www.usatoday.com/news/education/2007-12-14-california-dean_N.htm  Read More & Comment...

Genuine Fakes

12/17/2007 09:25 AM |

You mean that thing about counterfeit drugs is for real! (After all, if it's on the front page of the New York Times it must be important.)

Here's a link to Walt Bogdanich's story in today's Gray Lady:

http://www.nytimes.com/2007/12/17/world/middleeast/17freezone.html?hp

To whet your appetite, here's how it begins ...

DUBAI, United Arab Emirates — Along a seemingly endless row of identical gray warehouses, a lone guard stands watch over a shuttered storage area with a peeling green and yellow sign: Euro Gulf Trading.

Three months ago, when the authorities announced that they had seized a large cache of counterfeit drugs from Euro Gulf’s warehouse deep inside a sprawling free trade zone here, they gave no hint of the raid’s global significance.

But an examination of the case reveals its link to a complex supply chain of fake drugs that ran from China through Hong Kong, the United Arab Emirates, Britain and the Bahamas, ultimately leading to an Internet pharmacy whose American customers believed they were buying medicine from Canada, according to interviews with regulators and drug company investigators in six countries.

The seizure highlights how counterfeit drugs move in a global economy, and why they are so difficult to trace. And it underscores the role played by free trade zones — areas specially designated by a growing number of countries to encourage trade, where tariffs are waived and there is minimal regulatory oversight.

And yet some members of Congress want to decrease regulatory oversight of counterfeiting. Go figure.  Read More & Comment...

WHO Says

12/17/2007 05:46 AM |

An op-ed, from the International Herald Tribune, by Dr. Howard Zucker, assistant director-general of the World Health Organization and chairman of the International Medical Products Anti-Counterfeiting Taskforce.

A plague of bad medicine

There is a silent killer loose in the streets of every major city from Beijing to New York. Each day this menace brings the threat of greater illness and even death to sick patients living on farms in Africa and in the bungalows of South America. The source of this global epidemic is
counterfeit medicines.

Unlike counterfeit purses or watches, there is no demand by consumers for fake drugs. No one - rich or poor, Chinese, American or African - seeks them out; their victims are always duped into believing they have the real thing.

The motivation is simple: counterfeiting drugs is big business today, and quite likely the fastest growing criminal activity on earth. According to the U.S.-based Center for Medicine in the Public Interest, counterfeit drug trafficking will be a $75 billion enterprise by 2010.

Here's the rest of Dr. Zucker's commentary:

http://www.iht.com/articles/2007/12/14/opinion/edzucker.php

An important read.  Read More & Comment...

Positive Pressure

12/14/2007 07:35 AM |

In the spirit of the season, some thoughts on how 2008 can be the year when we all decide to "just get along" and focus on the public health and personalized medicine rather than, well, more personalized agendas.

As far as a "more effective" FDA is concerned, consider this -- effective regulation can’t happen in a vacuum. Unlike in the movies, the best new ideas, be they scientific or otherwise, rarely spring fully-grown from the head of anyone -- even our elected representatives. That means industry and Congress and academia and patient groups and physicians ... and the FDA must have close ties. Ties that bind rather then cut, with relationships built on trust and mutual respect. That's the only way to achieve anything worthwhile. "The beatings will continue until morale improves" isn't working. And while there will always be tension between regulator and regulated, between agency and oversight authority, such tension can be productive, creative tension.

Diamonds, after all, are the result of pressure.   Read More & Comment...

Heartburn, yes. Statins, no.

12/14/2007 05:59 AM |

10-2 against. So it doesn't look like we'll be seeing OTC statins any time soon. All the more reason to carefully watch the FDA's words and actions viz BTC. If all this is giving you heartburn -- well at least those medications you can get without a prescription.  Read More & Comment...

Juiced Baseball:The Bottom Line is No One Really Cared

12/13/2007 09:01 PM |

How did steroids spread through MLB. It started in college and high school where coaches and parents looked the other way. And it continued in The Show where management from the GMs to the owners knew about it and did nothing. Retired players who I know realize that 'roids were and are illegal but have said that a clear no tolerance policy would have wipe them out a long time ago.

Meanwhile Senator Mitchell's report has some very interesting things to say about how easy it is for players -- or anyone -- to get steroids and HGH through internet pharmacies and Canada. What sort of signal does it send when Congress handcuffs the federal law enforcement agencies and the FDA from intercepting such products in it's stupid pursuit of drug importation. The same signal MLB ownership sent to players when it said it wanted to crack down on steroid use but never really got tough.

Here's a link to the Yahoo sport site that in turn has a link to the report.

http://sports.yahoo.com/  Read More & Comment...

Value-Based Insurance Design

12/13/2007 10:27 AM |

Just participated on a "blogger conference call" with Mark Fendrick (University of Michigan) and Michael Chernew (Harvard University). They are the co-directors of the Center for Value-Based Insurance Design.

The VBID Center sounds like an interesting proposition. For more detail check out their website:

http://www.sph.umich.edu/vbidcenter/

Many interesting points were brought up -- not the least of which was the issue of whether or not -- considering the relatively truncated lifespan of any individual's relationship with a given private payer -- Big Insurance can be convinced to offer more efficient programs that incent aggressive preventative and chronic care.

And, since the VBID program is based in the Wolverine State, I asked if they thought the new GM/Union agreement over health care would result in more patient-centric programs. Both Dr. Fendrick and Dr. Chernew demurred from making a prediction. Typical academics!

I think it will. Because (1) These are union employees who (at least in theory) will be with the insurance plan for an extended period -- so additional up-front costs (aka "investments") can be recouped over a longer period of time via enhanced productivity and fewer acute health care events and (2) Unions exist to serve their members rather then themselves (I know -- at least in theory) and should, therefore, be more willing to spend more money upfront.

Whether or not my prediction turns out to be correct -- it's a good initial litmus test for the general theory.

The VBID Center also said all the right things about the value of reimbursing for appropriate diagnostics (genomic and otherwise) -- specifically giving the thumbs up to genetic tests for Warfarin and the BRCAs.

The call lasted about an hour with many intelligent questions from the blogger audience. Strangely though, the VBID folks said their "consultant" had told them to expect a blogger call to last for only 20-25 minutes. Peculiar. But, in any event, it was time well spent.  Read More & Comment...

Shots in the Dark

12/13/2007 07:28 AM |

Per Dr. Bob's post below on vaccines, let me relate what my pediatrician buddy says to parents who don't want their children vaccinated --

"It's your choice. But if you choose not to have your child vaccinated then you cannot be my patient."

This is serious business folks. Voodoo science that scares parents away from accepting childhood vaccinations (and the lawyers who would fan those false flames for profit) is one of the most serious public health risks our nation faces.

And certainly one of the most avoidable.  Read More & Comment...

Vaccine Recall Retort

12/13/2007 06:37 AM |

In her excellent piece about the Merck vaccine recall Linda Johnson anticipates -- correctly -- the coming storm from the crazies who believe that we should really be scared and angry about how the fact that kids don't even need vaccines to begin with:

"The recall is likely to heighten a debate over childhood vaccines, their safety and whether too many are required. Some parents are distrustful and suspect some vaccines of being linked to autism, although scientific studies have not shown a connection. "

Sad but true. And Johnson forgot to mention the barrage of bottom feeding trial lawyers who will try to sue Merck in the wake of the recall.

http://news.yahoo.com/s/ap/20071213/ap_on_he_me/vaccine_recall  Read More & Comment...

Hutt! Hutt! Hutt!

12/13/2007 05:35 AM |

If the recent report of the FDA's Subcommittee on Science and Technology ("FDA Science and Mission at Risk") wasn't enough of a wake-up call -- you should (1) check your pulse and make sure you are still breathing and (2) read the very un-sugar coated comments of Advisory Board member Peter Barton Hutt. They're must reading.

And here they are:

Download file

But Peter, what do you really think?  Read More & Comment...

Why Don't Pregnant Women Tip Over?

12/12/2007 04:00 PM |

There is no punchline...yet. Only the hard work of dedicated scientists seeking a serious answer.

http://news.yahoo.com/s/livescience/20071212/sc_livescience/womenevolvemorespinetocarrybabies

Meanwhile, this guy brings new meaning to the word "suicide bomber"

AP: Man nearly dies downing vodka at airport

A man nearly died from alcohol poisoning after quaffing two pints of vodka at an airport security check instead of handing it over to comply with new rules about carrying liquids aboard a plane, police said Wednesday.

http://news.yahoo.com/s/ap/20071212/ap_on_re_eu/airport_vodka  Read More & Comment...