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Latest release on the FDA website (truncated by me, with the full verbiage at

FDA’s Accomplishments in 2005

Innovative Technology

The FDA made progress in implementing its Critical Path initiative, a pioneering project that seeks to apply the best available science to the medical product development process by creating novel tools — such as proven biomarkers and simulation models — for assessment of the safety and effectiveness of drugs and medical devices.

As part of this initiative, the FDA conducted a workshop with The Drug Information Association and The Biotechnology Industry Association to discuss ways of routinely using new imaging techniques in drug development. The agency also created a non-regulatory pathway for discussions with sponsors about certain issues involving submission and use of pharmacogenomic data; concluded an agreement with BG Medicine, a biotechnology research company, to collaborate on discovering signs of liver toxicity in the initial stages of drug development; and published a final guidance on the development of pharmacogenomic data that could help predict the optimum treatment for each individual patient.

Patient and Consumer Protection

The FDA launched several initiatives to reform and make more transparent the system that protects patients from adverse events associated with marketed drugs. The steps taken in 2005 included a contract with the Institute of Medicine to study the effectiveness of the U.S. drug safety system; the appointment of 31 top drug experts to a novel Drug Safety Oversight Board that oversees the management of important drug safety issues; and four contracts to improve FDA’s access to databases that can help identify rare side effects of medicines. Other examples of patient and consumer safety-oriented projects included FDA’s investigation of the mechanical strength of vertebrae following injections with bone glue, the most common treatment for compression fractures that affect a quarter of all women over the age of 50; and studies of the toxicity of acrylamide in food.

FDA made important contributions to the nation’s preparedness for the potential influenza pandemic. The agency provided guidance to speed vaccine manufacturing and availability; sought to increase the number of vaccine manufacturers and their capacity; and addressed such needs as the creation of pandemic strain libraries, for use in vaccine manufacturing and development, and improved assays and testing.


To help protect the nation against bioterrorism, Congress has charged the FDA with helping to secure the food supply and encouraging the development and availability of counter-terrorism medical products. As part of this program, the FDA last year strengthened the protection against the effects of inhaled anthrax by approving several generic versions of Cipro (ciprofloxacin). The agency also approved ThyroShield (potassium iodide oral solution) for use in radiation emergencies and developed draft guidance on studies of products to eliminate inhaled, absorbed, or ingested radioactive contaminants.

CFSAN, along with the U.S. Department of Agriculture, the Federal Bureau of Investigation, and the Department of Homeland Security, announced a new collaborative effort with states and private industry to protect the nation’s food supply from terrorist threats through the Strategic Partnership Program Agroterrorism Initiative. CFSAN has spearheaded this effort to identify sector-wide vulnerabilities, mitigation strategies and research needs to protect our nation’s food supply.

Better Manufacturing Practices

Another major FDA priority in 2005 was to ensure the proper manufacture of medications by strengthening compliance with the recently overhauled pharmaceutical standards Good Manufacturing Practices (GMPs). An example of this emphasis has been the agency’s close cooperation with the United Kingdom’s Medicines and Health Products Regulatory Agency (MHRA) in ensuring the correction of sterility failures that had caused the MHRA to suspend the license for Chiron, a major producer of influenza vaccine for the United States.

Both FDA and MHRA provided extensive input on Chiron’s remediation plan for the firm’s facility in Liverpool, and repeatedly inspected its implementation. The joint efforts resulted in the release and delivery of the Fluvirin influenza vaccine to the United States for the 2005-2006 influenza season.

Modernizing FDA

To help protect patients from medication errors, to better inform practitioners about the information they need to use products most safely, and to better enable the use of electronic labeling of drug and biologic products, FDA finalized its new rules governing the format and content of the required information (labeling) that must accompany drug and biologic products when they are marketed in the United States.

Note to Senator Grassley: Please feel free to send a thank-you note to the hard working men and women of the FDA.

“Doctor experienced in bird flu doubts forecast pandemic”
NY Times, March 28, 2006

“U.N. expert says bird flu virus has him “quite scared”
NY Times, March 28. 2006

I guess this is what’s called “balanced” reporting.

No matter how you say it, prescription drug counterfeiting is international health care terrorism

(And so much for certain US politicians who claim that Europe has no problem with counterfeiting.)

EU Says Counterfeit Drugs On The Rise In Europe

BRUSSELS (AP) — An increasing amount of fake drugs is being sold over the Internet in Europe, the European Union warned Monday.The European Commission said a recent survey conducted by E.U. member states, identified 170 fake medicines that were being distributed illegally, mostly through Web sites offering fake or unauthorized lifestyle drugs, growth hormones and sleeping drugs … “I am alarmed at the ever increasing number of counterfeit medicines sold via the Internet. This represents a real danger to the health of patients,” said E.U. Enterprise Commissioner Guenther Verheugen.Lifestyle drugs, such as Viagra, and essential medicines such as antibiotics and insulin are particularly popular with counterfeiters, but there’s also an increasing number of fake contact lenses and even materials such as surgical mesh. Experts warned buying health products over the Internet can be a major health risk.

An excellent article in today’s edition of the Chicago Sun-Times on the strides we are making towards making acute diseases chronic conditions. Here’s a sample:

In the last 25 years, the death rate from heart disease has been cut in half. On another front, the number of cancer deaths recently dropped for the first time in more than 70 years. Yet heart disease and cancer together still kill more Americans than all other causes of deaths combined. Researchers are developing high-tech new treatments such as targeted cancer drugs and stem cell heart therapies.

But the best way to fight the Big Killers is to not get sick in the first place. If we all simply took better care of ourselves, experts say, we could cut the death toll from cancer and heart disease by at least 50 percent.

It’s worth a read. Here’s the link:

Pharma's Big Blues

  • 03.27.2006

Caroline Kovac (IBM’s Princess of Prescience) on what Big Pharma can learn from Big Blue:

“Replace the word blockbuster with mainframe and then we can talk.”

Bonjour Amigo

  • 03.27.2006

Nope, not a mixed metaphor. I just returned from Brussels where I spoke on what the Europeans call “information to patients” or “ItP” (what we heathens on this side of the Atlantic refer to as “direct to patient communications”). The event was at the Amigo Hotel. (For you trivia buffs, this hotel used to be a prison — and one of its most famous guests was Karl Marx.)

I spoke on the American experience with DTC advertising (both the pros and the problems) and my fellow panelist, James Copping, talked about how the EU is trying to figure out what to do next, since “not American-style drug advertising” is not a go-forward policy. Jim’s a player. He’s the Principal Administrator for the EU’s Enterprise and Industry Directorate-General, the body drafting the EU’s go-forward recommendations.

One interchange between Jim and me that is worth sharing:

COPPING: “We must find new ways to regulate health care information to patients.”

PITTS: “Jim, I think a better way to frame the question is to say that you need to find new ways to facilitate health care information to patients.”

COPPING: “Yes, that’s right.”

God’s speed Mr. Copping.

Here’s an exciting timely and important new paper on what antihypertensives have accomplished and what more could be accomplished if people were treated to guideline. It’s a clarion call to address our nation’s (indeed the globe’s) chronic health care problem — ignoring the urgency of focusing on chronic care.

The Impact of Antihypertensive Drugs on the Number and Risk of Death,
Stroke and Myocardial Infarction in the United States by Genia Long,
David Cutler, Ernst R. Berndt, Jimmy Royer, Andree-Anne Fournier, Alicia
Sasser, Pierre Cremieux #12096 (AG HC)


Estimating the value of medical innovation is a continual challenge.

In this research, we quantify the impact of antihypertensive therapy on U.S. blood pressures, risk and number of heart attacks, strokes, and deaths. We also consider the potential for further improvements.

We estimate the value of innovation using equations relating blood pressure to adverse outcomes from the Framingham Heart Study. Our results show that without antihypertensive therapy, 1999-2000 average blood pressure for the U.S. population age 40 plus would have been 10-13 percent higher. 86,000 excess premature deaths from cardiovascular disease (2001), and 833,000 hospital discharges for stroke and heart attacks (2002) would have occurred. Life expectancy would be 0.5 (men) and 0.4 (women) years lower. At guideline care, there would have been 89,000 fewer premature deaths (2001) and 420,000 fewer hospital discharges for stroke and heart attack (2002) than observed. Our analysis suggests that antihypertensive therapy has had a significant impact on cardiovascular health outcomes but that mortality gains would have been approximately twice as high if guideline care had been achieved for all.

Here’s the link:

New state-by-state fact sheets are now available at the Medicare Rx Education Network website.

Here’s the link:

According to Canadian law enforcement authorities, the Hell’s Angels used their Canada-wide connections to supply a major drug trafficking network that operated in the lower Laurentians. Police seized 49 kilograms of cocaine and smaller quantities of hashish and marijuana. They also found more than 136,000 Viagra pills. Other people are still being sought on warrants in the on-going investigation, dubbed Project Piranha.

I’m blogging to you from the Arizona State University conference, “Transforming American Healthcare Over the Next Decade.” Organized by ASU, the C-Path Institute (led by CMPI board member Dr. Ray Woosley) and CMPI — this event brings together many of the leading thinkers on 21st century medicine.

Here are a few snippets:

The Second Hundred Years

“When you compare what’s available today versus 100 years ago you have to wonder whether we’re not spending enough on health care.” (Senator Jon Kyl, R, AZ)

T.S. Eliot and the Critical Path

“We must transcend mindless empiricism. Today medicine is still an empirical science. We still approach it as a one-size-fits-all situation. T.S. Eliot wrote that ‘Hell is the place where nothing connects.’ We must confront the unacceptable cost of an unconnected healthcare system.” (George Poste, MD, The Biodesign Institute, ASU)

Do not take this medication if you operate heavy machinery or are African-American

“The Critical Path will lead to advances such as gene or haplotype specific labeling as well as ethnopharmacology.” (George Poste, MD)

The Problem in a Snapshot

“Are today’s pharmaceuticals the Kodak film of the Digital Age?” (Ray Woosley, MD)

An Alliterative Illustration

“21st century medicine must be patient-centric, proactive, preventive, and predictive.” (Caroline Kovac, IBM)

And in case you don’t think regulators have a sense of humor

“Relative to polymorphic metabolism, slow metabolizers are cheap dates for their healthcare providers.” (Janet Woodcock, MD, FDA Deputy Commissioner and COO)


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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