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

ALSO: Please join me at:

GxP Perspectives LinkedIn Group

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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.


HIV/AIDS Drugs: Funding in Question

July 4, 2010

AIDS Drugs Funds

HIV/AIDS Crisis Continues

The economic downturn has hurt funding for HIV/AIDS drug subsidies for life-sustaining programs that provide antiretroviral drugs to patients who cannot afford them. In a July 1st article by Kevin Sack in the New York Times, there are eleven states that have closed enrollment to the program including Florida, with the third highest number of people with HIV/AIDS after California and New York. The lack of drugs can cause people who are HIV positive to develop full blown AIDS, increase transmitting the virus, and require expensive hospitalizations. Other measures include paring back the number of drugs on the approved formulary and placing patients on waiting lists to receive necessary treatment.

It is a stark reminder that AIDS is still a major public health issue, not only in developing countries in sub-Saharan Africa, but in communities across the United States. To get a better perspective in my own home town of Tacoma, WA, I asked Duane Wilkerson, Executive Director of the Pierce County AIDS Foundation how bad the problem was here. Duane gave me the reality on the ground in 2010.

GxP Perspectives: Does the cutback in funds mentioned in the NY Times article impact local agencies such as the Pierce County AIDS Foundation (PCAF)?

Duane Wilkerson (DW): Washington State is a little luckier than some states. People who are diagnosed with AIDS are able to get AIDS drugs in a variety of ways. Through the state ADAP program and different insurance options for drug coverage, no one in Washington State goes without AIDS drugs who need them.

GxP Perspectives: How have the current economic problems impacted non-profit agencies like PCAF?

DW: We are seen cutbacks in prevention more than client services. Because of the State budget crisis combined with a reduction from CDC for prevention services, several of our prevention contracts have been reduced from the original award levels.

GxP Perspectives: Have you seen an increase of clients who had previously stabilized their healthcare regimen?

DW: Yes. We saw an increase of 25% in 2009 from 2008. Much of this increase represented clients who had not needed our services for awhile, but came back because of the effect of the economy on their economic situation and consequently their health status.

GxP Perspectives:What is the most cost-effective way to use funds for the treatment/prevention of HIV/AIDS?

AIDS Drug Funding

An Ounce of Prevention...

DW: This has answers at several layers. First prevention is clearly the most cost-effective strategy. If you compare the cost of an effective, evidenced-based prevention program per person to the cost of a lifetime of medical/health/drug care for someone who is living with AIDS, you will see a huge difference. Within effective, evidenced-based prevention programs, group-level interventions are consistently evaluated as being the most effective and cost effective. One-on-one level programs are very cost/labor intensive, though some are very effective; community-level programs are often not as expensive, but affords very little program effectiveness in critical areas of behavior change (e.g., reducing sexual partners, using condoms more consistently, etc.). Treatment programs, started early in the progression of the disease can be cost effective (compared to later initiation of treatment), in they can keep the viral load at a much lower level for much of a person’s life; allowing them to live longer and with better health.

GxP Perspectives: Are clinical trials the answer to the AIDS pandemic? Is there a magic bullet in the works?

DW: Clearly not yet. Will they ever be? It seems a moot question for me at the moment. There have been so many “promising” research trials, in the last ten or more years, that have cost enormous amounts of money. To date, none of them have been successful. Certainly we can’t wait or count on a magic pill. We must increase the prevention efforts because they have been shown to work.

GxP Perspectives: Readers of the Blog are from across the country and are also in international locations. I know that local organizations need funds but how can people help out on a national or international level?

DW:

AIDS drugs funds

Needle Exchange Programs Have Proven Effective In Preventing the Spread of HIV

I think one of the most important ways to contribute to (ending) the epidemic, on the national and international level ,is getting involved in policy decisions that guide how prevention is done. For example, in the U.S., one of the most successful behavioral interventions that we know of is needle/syringe exchange. There is no serious debate in the field that this works, and works well. Yet because of political decisions the U.S. government will not fund exchange programs with any federal funds. In addition they put these restrictions on funds for international efforts (through PEPFAR), along with other political motivated restrictions such as not funding any program that also provides family planning services. These restrictions have nothing to do with good public health practices and everything to do with politics.

GxP Perspectives: What else should we be doing about the AIDS pandemic?

drugs HIV AIDS funding

HIV Infections Continue in the United Stas and Worldwide

DW: In the U.S. we can keep the issue of HIV infection in the forefront of public health concerns. In a country which has no attention span to speak of, too many people assume it is no longer a problem. This despite the fact that 56,000 new infections are still occurring in this country each year. Another important contribution would be to be open and public in the support of people who are HIV infected. Stigma and discrimination are still very much alive and contribute to the pandemic through ignorance, fear, and oppression of those who are infected. Finally you can be tested if you have engaged in any of the risk behaviors that can transmit HIV (e.g., unprotected sex with a partner whose HIV status is unknown, using unsterile needles for any kind of reason, but particularly injection drug use).

GxP Perspectives: Why is it important to society that people who are HIV positive receive these expensive drugs?

DW: Because it has a direct impact on public health and the economy. People who are on anti-viral medications (HAART therapy) have a lower viral load (the amount of the HIV virus in their blood system). This in turn makes them less able to infect others compared to those with high levels in their blood. Fewer infections will occur with more HIV infected people on good medications. This then has obvious economic implications related to the cost of treated each person who is HIV positive.

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AIDS.GOV for additional informating on HIV/AIDS

Pierce County Aids Foundation

And on another issue requiring our attention:

Update: NIH has provided funding for ten international malaria research centers. Read the 8 July 2010 Press Release

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FDA Budget Asks For $4,030,000,000

February 2, 2010

FDA has requested $4.03 Billion, a 23% increase, for fiscal year 2011. (I hope I got all the zeros right.) This would be the largest budget in FDA history. Much of the increase is for the new tobacco program. The largest chunk is for food safety and we have an analysis of that by Sid Olufs, the blog’s resident book reviewer and food safety analyst. research informed consent IRB FDA

However, the issue of the FDA budget request has been lost in the light of the deficit and other news. On the Blogroll FiercePharma, but not FierceBiotech, comments as well as Gooznews on Health. Before we get to Sid’s comments I have a few short, but important items to report. First, here is the FDA press release on the budget:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm199516.htm

UPDATE: This Sunday, the 18th of April, the Pew Research Center released a devastating report on the decline in confidence in government over the past 12 years, including a 17% decline for FDA. Pew says, “The declines have been particularly large for the Department of Education, the FDA, the Social Security Administration, as well as the EPA, NASA and the CDC.” Ouch.

(Original Post):

This Sunday, the 7th of February, is the 10th National Black HIV/AIDS Awareness Day and February is Black History Month. Although African-Americans are only 13% of the U.S. population, they have nearly 50% of the newly diagnosed cases of HIV/AIDS. Here is a statement by Dr. Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Disease that conducts AIDS research world wide:

http://www3.niaid.nih.gov/news/newsreleases/2010/BAAID10.htm

Finally there is an interesting “Frequent Flyer” column in the business section of the NY Times. It is written by a retired physics professor, Robert Kolenkow, who is a diabetic. I am a Type 1 diabetic and a very frequent flyer. I have Travel Too Much status with Alaska Airlines (They call it, “MVP Gold”). I have always found it challenging to manage my diabetes on board a packed coach cabin going across the country so I was interested in what Professor Kolenkow had to say. He participates in a diabetes mentoring group called A1C Champions. They are sponsored by Sanofi-Aventis. Since I use Sanofi insulin I am not sure how happy I am about this. However, you can take a look and judge for yourself.

Here is a link to A1C Champions:

http://www.a1cchampions.com/

Here is a link to the article:

http://www.nytimes.com/2010/02/02/business/02flier.html?ref=todayspaper

Guest Commentary by Sid Olufs:

Paying for a Difficult Job

In an earlier post I briefly described the ambitious agenda facing the new Deputy Director for Food, Michael R. Taylor (FDA Has a New Look for Food). It included these lines describing his responsibilities: “inspection and ensuring compliance with rules, coordination with state and local agencies who do much of the work of food safety, responses to “incidents” that hurt people, getting a handle on imported items that find their way into food, sponsoring and organizing the scientific and technical research needed to design a safe food system, including animal feed and veterinary care, and building the information network that helps to knit all of these together.”

Others have looked at the costs of building a food safety system that can do all of this adequately. In the most comprehensive outside analysis of FDA responsibilities and capacity, the authors concluded that the FDA FDA Budgetis critically underfunded in its science-based regulation and decision making, so much so as to put public health at risk. (FDA Science and Mission at Risk, Report of the Subcommittee on Science and Technology, Prepared for FDA Science Board, November 2007.) The Congressional Budget Office estimate of the costs of implementing HR 2749, which falls short of the more complete goals of FDA Science and Mission at Risk, came to almost half a billion dollars a year for the first few years of transition, and about a billion dollars per year thereafter. (CBO Cost Estimate, h.r. 2749, July 24, 2009.)

The Obama administration has now released its budget for FY2011. As described in more detail in the agency budget documents submitted to Congress, FDA requested about $220 million in the form of fee-based inspections, plus additional spending over current spending which brought the total food system upgrade request to about $318 million in additional money for 2011. See the attached link for a brief summary:

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM199447.pdf

I spent a little time looking at the documents, and only found about $290 million in budget increases in the documents released by OMB. See their detailed HHS budget description, at:


http://www.whitehouse.gov/omb/budget/fy2011/assets/hhs.pdf

The first three pages are the FDA budget summary (the pagination starts at p. 461).) You will see the $220 million on 09.02 Food Registration and Inspection User Fee, on the third page (page # 463) of this document. The fees are “proposed.”

I found no separate discussion of the resources devoted to upgrading the FDA’s information technology, a critical resource in the needed upgrades. It could be that a separate item is included for this, but I searched in vain in the detailed agency appendices and in the Analytical Perspectives that accompany the Budget.

Judging just by the number referred to here, it does appear the Obama administration is taking food seriously, at about two-thirds to three-quarters of the resource level implied by the panel of experts that assembled FDA Science and Mission at Risk. I for one will find it interesting to read how far down that road this new budget authority will take us.

By Sid Olufs

Blogroll Pick: Gooznews on Health– With every post, I am trying to highlight one of the blogs on the Blogroll to your right. This time Gooznews has some interesting comments on the FDA Budget requests.

http://www.gooznews.com/

REMEMBER, YOUR COMMENTS ARE ALWAYS WELCOME !!!

You can read additional posts on FDA Commentaries here:

https://carl1anderson.wordpress.com/category/fda-commentaries/

You can read additional posts on Food Safety here:

https://carl1anderson.wordpress.com/category/food-safety/

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Blogroll: For those of you interested in the financial aspects of our industry – and others – Check out Hedge Hodge at:

http://www.hedgehogs.net/


Economists, Technology, & Clinical Trials

February 1, 2010

God bless Joseph Stigltz. There is a brief interview with him in the Sunday NY Times Magazine by Deborah Solomon, “Questions for Joseph Stiglitz.” There is a link at the bottom of this post. I have only started paying close attention to what economists have to say in the past few years. This certainly intensified when all hell broke loose in the fall of 2008. Joseph Stiglitz, a professor at Columbia, is a Nobel prize laureate and a very smart man. He also has a dry wit that I find quite funny (some people have doubts about my sense of humor) and I have just ordered his new book, “Freefall: America, Freemarkets, and the Sinking of the World Economy.” I definitely want to know what he has to say about it all.

FDA

Prioritize ???

However, what really caught my attention and led me to write this post is one of the last questions Solomon had for Stiglitz when she asked, “By the way, when I tried you on your cell phone, a voice said, ‘This is the number for Joseph Stiglitz, but he doesn’t check his messages.'” His response? “I just never figured out that part of the cellphone.”

This blog isn’t about economists, its about the regulation of health products by FDA in general and about clinical trials in particular. Clinical trials are very expensive to conduct. In addition, the massive amounts of recordkeeping involved leads to routine mistakes and the destruction of a great many trees. There has been a big push towards electronic medical and regulatory records, electronic case report forms and technology in general. This has generated discussion and debate about how these records should be regulated and whatsteps we need to take. FDA’s initial effort to regulate computerized systems, Part 11; Electronic Records, Electronic Signatures, was met with sharp resistance from industry and enforcement has been scaled back considerably as FDA utilizes “enforcement discretion.” However, most of us understand that these systems need to be dependable and that means, in some way, shape, or form, that they be “validated.”

Unfortunately what I see a lot is that the quality of the system used to maintain records is considered more important than the quality of the actual records that contain the data used to approve new drugs and clinical trials FDAmedical devices. Some folks seem to forget that technology is a means to an end (full disclosure: I am not very tech savvy). As a result, we have seen an increase in the number of FDA enforcement actions. FDA Warning Letters to clinical sites have skyrocketed in the past few years. And in my viewpoint one of the major reasons is the poor quality of clinical trial protocols and recordkeeping. Sometimes you need to take a look at the basics of what you are doing.

Which brings me back to Joseph Stiglitz. Here is a very smart man who is engaged with problem solving. Very Big Problems that impact us all. Yet he doesn’t know how to check his voice mail. As far as I’m concerned, its a question of knowing priorities. Just stop and think about which is a more important activity; understanding the complex economic issues that caused the Wall Street meltdown, or playing with your Blackberry? I appreciate the Stiglitz approach.

Here is a link to the Stiglitz interview by Deborah Solomon:

http://www.nytimes.com/2010/01/31/magazine/31fob-q4-t.html?ref=todayspaper

REMEMBER, YOUR COMMENTS ARE ALWAYS WELCOME !!!

Blogroll Pick: Paul Krugman’s Blog. I’m continuing to list a site on the Blogroll (to your right) each time I publish a post. As long as we are on the topic of economics why don’t we take a look at what another Nobel laureate has to say? Find it on the Blogroll along with a number of other interesting places to visit. Have fun.

http://krugman.blogs.nytimes.com/

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Anesthesiologist Accused of Fake Drug Studies

January 18, 2010

Federal agencies including the FDA’s Office of Criminal Investigations and the FBI have joined in an investigation of Dr. Scott Reuben, the former chief of acute pain at the Bay Medical Center in Springfield, MA. Fake drug study FDA clinical trialDr. Reuben was accused of faking clinical trials for pain medications including the Cox-2 inhibitors Vioxx by Merck and Bextra by Pfizer. The Associated Press reports that Dr. Rueben may have agreed to a plea bargain with the U.S. Attorney’s office in exchange for more lenient sentencing. The Journal of Anesthesia and Analgesia and the Journal of Anesthesiology have pulled 13 of Dr. Reuben’s published articles. Read more:


http://www.medicalnewstoday.com/articles/176232.php

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