Happy Holidays to One and All

December 23, 2011

Happy Holidays

Happy Holidays

It’s the time of the year to think of families, fun, and maybe those less fortunate than ourselves. Whatever holiday you celebrate, I hope that it is super. We have a Guest Commentary coming Monday on the controversial decision regarding Plan B by DHHS Secretary Sebelius. Then we will have end of year wrap ups on Warning Letters for Active Pharmaceutical Ingredients, Clinical Investigators, and Sponsors. GxP Perspectives has a new Editorial Intern, Francesca Carreras-Velez. We’ll see what she has to say! As always, I am looking for Guest Commentaries. For more info, please leave me a message.

Happy Holidays One and All!

Carl Anderson, GxP Perspectives


GxP Perspectives: Summer Reading

July 25, 2011

GxP Summer Reading

Summer Reading for GxP Professionals

GxP Perspectives firmly believes that summertime means more vacations, less work, and some different recommendations for your reading list. I am actually going to NOT be traveling for the entire month of August. I have weeds to pull, a fence to paint (can Tom Sawyer give me a call), Some hiking to do, and a blog to keep up (to a certain degree). Like most of you, I also enjoy reading. So here are some of my favorite sites for your perusal. Some are industry, some are not. All of them are good. I have really been enjoying the Harvard Business Review “Management Tip of the Day.” If you have other suggestions, please let us know.

UPDATE: Dr. Hamburg’s Op/Ed article printed in the Wall Street Journal.

7 August Update: Not to be missed is the Essex IRB Warning Letter. Earlier this year FDA warned of a fictitious submission to central IRBs. Essex took the bait and approved the fictitious submission.

Harvard Business Review Management Tips is a daily, very brief, “tip of the day.” I find them useful, well-written, and usually making sense. They have many products that they would like to sell you.

What I watched Last Night is a periodic, non-commercial blog about movies. No, not current Hollywood fare, but movies that this acclaimed video maker and film critic actually enjoys. It’s summertime and what better season to watch a movie.

MedCity News A weekly compilation of articles on this commercial website.

AbsoluteArts Because we all need some art in our life.

GCP works The twitter account of GCP Professional Tina Avanzato Chiodo.

NYRblog The blog of the NY Review of Books. If I could only subscribe to one print journal it would be the New York Review of Books.

PharmTech Talk is the blog of Pharmaceutical Technology. All play and no work…

Guardian.co.uk from London. The Guardian provides a different news perspective for readers from the U.S. who can see what others think of us. I like the column from Hadley Freeman on the ratings downgrade. The Guardian has a lot of very good writers.

Science 2.0 Now featuring “Decapitation and the Wave of Death” (now how cool is that?)

Value Added Connects: This blog from India discusses the inspections of CROs by the DCGI (Drugs Controller General of India). A good way to learn more about clinical trials in India.

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Please leave your comments on summertime reading


DTC Drug Ads: A Common Sense Solution

February 10, 2011

DTC drug ads common sense approach

Should Congress Pass New Legislation on DTC Drug Ads?

One of the most controversial developments in the pharmaceutical industry in recent years was the approval of direct-to-consumer (DTC) ads that began popping up in 1997. Multi-colored butterflies helping promote sleeping pills didn’t seem to many to be in the best interests of public health. Drug companies have responded by saying that the DTC drug ads helped with patient education. Critics such as Marcia Angell, the former editor of the New England Journal of Medicine, has sharply disputed the drug companies claim about DTC ads. Her book, “The Truth About Drug Companies” is a must read for people interested in the pharmaceutical industry.

In todays New York Times we have an op-ed article that proposes what to me is a common sense solution. Ian D. Spatz, a former pharmaceutical company executive, writes that DTC ads also hurt drug companies and a solution to the issue is necessary. He proposes that Congress pass legislation that would alter the content and intent of DTC drug ads:

A more effective way to limit the ads would be for Congress to pass legislation that would allow drug companies to cooperate with one another, and with physician and patient organizations, to develop joint ad campaigns that are specific to certain diseases and conditions but not to any particular drug. These ads would inform consumers about the disease; its treatment options, including pharmaceuticals; and how to gain further information not biased toward any particular brand.”

An interesting approach and one, that I think, should be considered.

NY Times: Better Drug Ads, Fewer Side Effects

The Truth About Drug Companies, by Marcia Angell

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On the Blogroll: Diabetes Self Management, well organized and informative

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MHRA and Clinical Trials– Read about the Academy of Medical Research Report by Nick Taylor in Outsourcing-Pharma


The Blog is Thankful

November 24, 2010

Thanksgiving

This Blog is Thankful for Each of You

Thanksgiving is my favorite holiday. And not just because of the food. I am pretty lucky any way you look at it and sometimes you need to say “thank you.” I would like to thank the hardworking professionals in government, clinical sites, academia, and industry who strive to bring safe and effective health products to the patients that need them. I am very thankful for the readers of this blog. I am certainly thankful for my clients, and oh-so-thankful to my family and friends.

I am also thankful to hard working people that make Thanksgiving possible, including the farmworkers who put food on our tables. It is hard, backbreaking work and deserving of our recognition and gratitude. Here is what photojournalist David Bacon has to say about a favorite Thanksgiving vegetable:

Thanksgiving

California Farmworker Harvesting Brussels Sprouts

Putting the food on the table is really one of the most important jobs people do, and one that gets the least acknowledgement and respect. So the next time you decide on brussels sprouts for dinner, first, don’t boil them. It removes those healthy anti-cancer chemicals. And don’t overcook them either – that’s what produces the sulfur taste many people don’t like. But then, when they’re out there on the table, remember who got them there.”

Photo by David Bacon

David’s Website with more photos and articles


TSA Screenings: A Root Cause Analysis of Public Outrage

November 22, 2010

TSA root cause analysis

Is TSA's Lack of Training a Root Cause of Outrage?

In reading reports of the TSA full body screening and aggressive body searches I have read little about training for the transportation security officers, called TSOs. Any good QA specialist would want to conduct a root cause analysis of the outrage that the public is expressing at TSA’s tactics. I have twice been a participant to the “enhanced” screening methods, both times at Boston’s Logan Airport, and noticed that the TSOs seemed to have no training or preparation for the new screening techniques. When the TSOs bark orders at people and fail to use a normal conversational tone, then they are probably going to offend the public. The Wall Street Journal Blog, The Middle Seat Terminal, reports that TSA has been audited by the Department of Homeland Security Inspector General’s Office and cited for numerous training failures. The WSJ Blog states:

“Among the shortcomings that the inspector general found: TSA doesn’t have standard processes to use screener test results, such as “covert testing’’ where government officials try to smuggle weapons through checkpoints, to evaluate and update training programs. On-the-job training is lacking, and TSA doesn’t have uniform steps to “to ensure that officers have the tools and time necessary to complete training requirements,’’ the IG’s report said.

In addition, there aren’t standard procedures for allocating equipment, support and time needed to complete training requirements, either, the report found.”

TSA and DHS need to look into the root cause of the public outrage. Any analysis would point out the training failures. It is one significant reason why the public is expressing outrage at the new screening techniques. Politicians need to note that it isn’t just a question of public safety vs. personal liberty. TSA just isn’t doing a very good job. Those of us who travel to earn a living are seeing it each time we fly.

The Middle Seat Terminal

DHS Report on TSA Training

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Happy Thanksgiving to one and all !!!


FDA & The 2010 Elections: A GxP Perspectives Editorial

November 3, 2010

FDA 2010 elections GxP Perspectives

Safe & Effective?

Since the appointment of Dr. Margaret Hamburg as FDA Commissioner FDA has made steady progress in modernizing the Agency. Will the 2010 elections undo that? Steve Grossman reported a few weeks ago in FDA Matters that “deficit hawks” could threaten future FDA funding. That funding provides consumer protection for 25% of the U.S. economy. Think back to the period before Dr. Hamburg’s appointment to the merry-go-round of ineffective FDA Commissioners and Acting Commissioners. The lack of effective leadership in an era of globalized food and drug industries is not the direction to be heading. Early entries into this blog were full of FDA follies. Now commentaries on GxP Perspectives are about the modernization of regulations for adverse event reporting. It has been quite a positive change. Here is an early post on Faulty Device Approvals.

2010 elections FDA GxP Perspectives

Just Where Should We Cut FDA Funding?

Think of the positive achievements of the past two years. The regulation of tobacco, new food safety initiatives, transparency on past FDA errors, hiring energetic staff who consider FDA’s mission one of public health. Now with deficits continuing to loom, there is talk of making the Bush tax cuts permanent and cutting back on essential consumer safety. Just where do you want to cut? Inspecting imported food? Oversight of clinical trials? Perhaps we should do away with post-market surveillance studies. After all, they didn’t help with Avandia. Now go to your medicine cabinet and take out a bottle, any bottle. Can you tell by looking at the tablet or capsule that the active pharmaceutical ingredient actually works? Is it safe and effective for its intended use? Was it manufactured under good manufacturing practices? If you can’t tell by looking at it then we need a strong FDA. GxP Perspectives isn’t sure the 2010 elections are going to help FDA. Time will tell.

Update: An additional statement from FDA Matters

On the Blogroll:

Alliance for a Stronger FDA

GxP Perspectives LinkedIn Group


How ‘Bout Them Giants?

November 1, 2010

Giants

Number 44- Willie McCovey in the 60s

I went to my first SF Giants game at the old Seals Stadium in 1958, the year they arrived from New York City. I got an autograph from the third sting catcher, Valmy Thomas. I don’t know how many freezing games I watched at Candlestick Park. Willie Mays, Willie McCovey, Orlando Cepeda, Juan Marichal, Gaylord Perry, Jack Clark, Will (The Thrill) Clark, Matt Williams, Rick Reuschel (let’s not talk about Barry Bonds), Fifty-two years later they finally win it all with guys named Lincecum, Rentaria, Posey, and Ross. How sweet it is.

This Blog resumes its normal programing sometime soon.


Top FDA, Health, and Science Blogs

September 8, 2010

FDA health science blogs

Hamlet and Yorick Discuss FDA Compliance, Health,
& Science Blogs

Here are some interesting blogs on the topics of FDA regulated industry, FDA regulations, health and science that regular readers of GxP Perspectives might enjoy while I am on vacation. Everyone should have a vacation now and then and I am going off for almost two weeks!

Acronym Required states they follow science and industry but don’t tell a lot about themselves. Interesting reading.

Applied Clinical Trials: Their blog is one of the best. Take their salary survey.

Chemistry Explained: A good site on a dry topic. Not an actual blog.

Compliance Zen: “Practical FDA compliance insights and intelligence.”

Diabetes Self Management Well organized and informative

Drug Health Supersite An eclectic mix.

Endocrine Today: “Clinical news on diabetes and endocrine disorders.”

Eye on FDA: Not my favorite but an important blog on FDA stuff.

FDA Law Blog: As described

FDA Matters: Feisty blog on FDA from Steven Grossman

GxP Lifeline: A Master Control Newsletter (commercial content and GxP news)

Medical Devices Today: From Elsevier (not feisty)

Partners in Health Blog: News about the health organization’s work in Haiti.

PharmaGossip: We all need a little gossip in our lives. This blog has the longest blogroll I have ever seen (almost). Blogs that everyone has heard of and that no one has heard of.

PharmTech Talk: Pharmaceutical Technology’s excellent blog.

Two Decades and Counting: A GxP professional’s blog that is well worth checking out.

WSJ Health Blog: A good blog from a newspaper that I don’t read.

FDA blog health science

Hamlet Should Have Taken More Vacations

On my return I hope to have a post on the new FDA Guidance: FAQ for IVDs. I also have several Guest Commentaries lined up on the TMF reference model, informed consent, and more! And as for Hamlet and Yorick, Hamlet never said that he knew him well. He did say that Yorick was, “a fellow of infinite jest, of most excellent fancy.” Sounds like a “to be” kind of guy. Unfortunately, the Hamlet of Ashland 2010 left a little to be desired. Oh well.

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Announcement: The 18th and 19th of January 2011 I will be at the conference for Developing CAPAs in the GCP Environment, Arlington, VA.


Avandia Causes Furor in UK

September 7, 2010

Furor in UK over Avandia

Furor in United Kingdom Over Avandia

An independent panel of experts has called for the diabetes drug Avandia to be pulled from the shelves in the UK according to the Medicines and Healthcare products Regulatory Agency (MHRA). However, MHRA is not taking action at this time stating that “would cause confustion” and that they are waiting for a decision by the European Medicines Agency. A furor has broke out among experts on why the drug was approved in the first place. The Guardian newspaper reports the following:

A BBC Panorama documentary broadcast tonight and a BMJ article published today question whether there has been a failure of the UK’s regulatory system. The BMJ article asks whether there was sufficient clinical evidence in the first place for the product to be licensed by the European Medicines Agency (EMA) in 2000.”

The EMA is due with an opinion later this month and GSK, the maker of Avandia, stated: “patient safety is our priority”.

Read The Guardian Article

Avandia has caused quite a furor in the United States as well. The drug’s future remains unclear. Read GxP Perspectives Coverage of
Avandia Advisory Committee Meetings

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Save The Date: On 4-5 November 2010 the Pacific Regional Chapter of the Society for Quality Assurance (PRCSQA) and the Organization of Regulatory and Clinical Associates (ORCA), a Pacific Northwest based organization, will co-sponsor a Fall Training on regulatory compliance topics in Seattle, WA.

The PRCSQA LinkedIn Group will update the agenda for the training. PRCSQA Fall Training workshops have traditionally been “at cost” and are an affordable training opportunity. The sessions will cover both GCPs and GLPs with speakers lined up on vendor management, quality systems, and GLP updates.

++++In news from GxP Perspectives++++

Read the updated article on the Form FDA 1572 in:

Applied Clinical Trials “Closing Thought” on FDA 1572

ALSO: Please join me on LinkedIn at:

GxP Perspectives LinkedIn Group

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AIDS 2010 Vienna- Protest on Funding & Hope for Prevention

July 19, 2010

AIDS Vienna 2010 protest funding

Vienna 2010 AIDS Conference Opens to Hope & Protest

The 2010 International AIDS Conference in Vienna started off with protests about the lack of funding and indifference from governmental leaders. According to a report by the Associated Press, Julio Montaner, the President of the International AIDS Society and Chair of the AIDS 2010 Conference, said that some governments with high HIV infection rates were, “irresponsible to the point of criminal negligence.” Protestors from ACT UP Paris disrupted a pre-conference meeting and a number of AIDS organizations decried the lack of funds to treat people living with HIV/AIDS and for prevention programs. There was also hope and progress reported with news of the CAPRISA Study in South Africa. A press release from the National Institute of Allergy & Infectious Diseases states:

For years, antiretroviral medicines have been effectively used to treat HIV infection. Through the successful conduct of the CAPRISA 004 study, we now have proof that an antiretroviral drug, in this case tenofovir, can be formulated into a vaginal gel that can protect women against HIV infection. Given that women make up the majority of new HIV infections throughout the world this finding is an important step toward empowering an at-risk population with a safe and effective HIV prevention tool.

Research into prevention is a positive step forward. And the conference gives the Bills of the world (Clinton and Gates) the opportunity to move AIDS research and funding forward. The HIV/AIDS protests from activists and concerns about continued funding have put the HIV/AIDS pandemic back in the headlines. You can follow bloggers at the Vienna 2010 AIDS Conference here:

AIDS 2010

A YouTube video of the AIDS protests is here: HIV/AIDS Protest and,

The NIAID CAPRISA Press Release

Day Two Update: Grim news was reported about injection drug users (IDUs) to the conference. AFP reports the following:

“Only five percent of all IDUs have access to a programme where they can swap used syringes for sterile ones, according to a study led by Louisa Degenhardt of the National Drug and Alcohol Research Centre at the University of New South Wales, Australia.

Only eight percent have safer, legal substitutes such as methadone to opiate drugs like heroin.

And only four percent of IDUs with HIV receive antiretroviral drugs, which can repress blood levels of the virus to such low levels that the risk of contaminating others can be slashed by more than 90 percent.

Another reason to stress prevention. Read the AFP Report

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Note of Blogger’s privilege: I am currently working in Washington, DC in absolutely Awful Weather. Trust me, it isn’t always easy being a freelance blogger. I can’t wait to return to the grey, cool weather in the Pacific Northwest. However, there is a Fringe Theater Festival that I hope to check out this weekend. I will spare you the details.


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