Happy Holidays

The Blogster is off to Arizona for a bit to have some holiday cheer and go hiking in the Rincon Mountains. I wish everyone out there in the blogosphere the best of all possible holidays.

CHEERS !!!

NIDPOE: An FDA Warning Letter on Steroids

It doesn’t happen very often but for the fourth time this year FDA has issued a NIDPOE letter, Notice of Intitiation of Disqualification Proceedings and Providing Opportunity to Explain. This is only for the most serious breaches of FDA regulations by a clinical investigator. The most recent letter is to Dr. Daniel Berger of Chicago. The letter lists some very serious charges against Dr. Berger. The first one is:

“1. You repeatedly or deliberately submitted false information to the sponsor in a required report [21 CFR 312.70(a)].

Multiple documents contain falsified information. For example:

a. For Subject 010414, the following forms contained fraudulent signatures, which represented that the forms were signed by one of the sub-investigators: Northstar Healthcare form dated 7/29/08, Inclusion Criteria form dated 7/29/08, Exclusion Criteria form dated 7/29/08, Assessment of (b)(4) Illnesses/Events form dated 7/29/08, Medical/Surgical History form dated 7/29/08, Physical Examination form dated 7/29/08, and the report for the EKG performed on 7/29/08.”

The list goes on from there. There really isn’t much to say if the charges can be substantiated. The Blog is unaware of Dr. Berger;s respone, if any. It will probably come from his attorney. I have trouble inserting links into a post (thanks, WordPress). I will try it below and also on the Blogroll to the right under “1 FDA NIDPOE Letters.” This should be on everyone’s bookmark list.

http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm092185.htm

Another IRB, Another FDA Warning Letter

FDA is keeping up its scrutiny of Institutional Review Boards with a Warning Letter to the Burzynski Research Institute IRB. This is a publicly traded, for profit company who decided to run their own IRB and dispense with the formalities, and expense, of an independent IRB. The result is a length 8 item Warning Letter listing many serious problems. They include “Failure to determine risks for subjects were minimized and risks to subjects were reasonabable in relation to anticipated benefits.”

I’ve actually never seen this charge before (if my poor memory isn’t failing me) and its a pretty big deal. BRI is a large operation and this is not a very good practice, approving studies of your own research institute that is a for-profit enterprise. I discussed the Warning Letter with a colleague familiar with the operations of IRBs who said, “I’ve never seen FDA look into the details of the (IRB) board’s operations before.” And I haven’t seen the Center for Drugs write so many Warning Letters to IRBs before. Very interesting. (See previous post on the Centra and Teneo Warning Letters.)

The Burzynski IRB Chair, Carlton F. Hazlewood, Ph.D., is also a director of the for-profit research institute, raising concerns about conflicts of interest. In fact, “The IRB failed to ensure that no member participated in the initial or continuing review of a project in which the member had a conflicting interest,” is the fourth charge in the Warning Letter. The IRB would also allow non-members to vote if a board member had a conflict. Thats another big problem. There are very specific rules about the membership of an IRB.

The company is run by physician and researcher Stanislaw Burzynski, MD, PhD who has been the President and Chairman of the Board of Directors of the Burzynski Research Institute since its inception in 1984. Read the Warning Letter for yourself. Here is the URL, (WordPress isn’t letting me insert a link):

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192711.htm

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192711.htm

FDA Hits ICON with Warning Letter for J & J Studies

FDA posted a new Warning Letter on its website to ICON Clinical Research, the CRO responsible for many of the activities that led to the Johnson & Johnson sponsor Warning Letter last August (see previous posts). The heavily redacted document lists J & J only as “(B) (4)” but it is easy to compare the two and see that they are related. This is the first time in Years, someone correct me if I’m wrong, that FDA has gone after a CRO for their contracted responsibilities with a sponsor of clinical trials. It was ICON that performed the monitoring responsibilities that led to both Warning Letters.

Up until now it looked like FDA would only go after the sponsor when things went wrong at a clinical site. In the Sanofi Aventis Warning Letter of October 2007 the CRO was mentioned but no Warning Letter followed. In the J & J Warning Letter the CRO was redacted out and it has taken four months for FDA to write the CRO a Warning Letter. However, now that it is out, it is quite a doozy. Read for yourself:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm193156.htm

More on the “artificial pancreas” at Diabetes Technology Conference

Here is a link to the Applied Clinical Trials online edition for an article written, by the Blogster, on the Diabetes Technology Conference and the “artificial pancreas.” ACT has a new feature on clinical trials for diabetes and other therapeutic areas including podcasts and other high tech features. Read for yourself:

http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Articles/FDA-Scientists-Recognized-at-Diabetes-Technology-M/ArticleStandard/Article/detail/645633?contextCategoryId=47497

Centra & Teneo IRBs Receive FDA Warning Letters

OK, I said that I was going to take a break until New Year’s. However, the letter to the Teneo IRB is an interesting FDA Warning Letter for several reasons. First, the Center for Biologics, FDA’s smallest for human clinical trial regulation, wrote the Warning Letter and they don’t do that frequently to IRBs. Second, the IRB was found to have two sets of meeting minutes in an effort to keep some activities out of the regulatory realm. Third, FDA told the IRB to stop approving studies or having current studies enroll new subjects “until adequate correction is made.” This is about as tough as it gets for an IRB. I am attaching a Thompson link about the Warning Letter. Now I am going to take a break from blogging (I think).

Update: Another IRB, another Warning Letter. Centra IRB in Lynchburg, VA received a Warning Letter dated 20 November 09 from the Center for Devices. These folks violated a couple of Big Deals about IRB review of research. First, they forgot to review approved studies after a year. Remember the “Tuskegee Syphilis Study?” What went wrong there was no continuing review of research. Even after they discovered that penicillin worked wonders on syphilis. Then Centra forgot how many people were needed for a quorum. You need a minimum number of IRB members to approve research. Then they forgot to write down what they did. Their minutes didn’t describe what happened at the meetings. If you didn’t document it then its just a rumor. These are basic things that anyone in the IRB business should know about. Read for yourself on the FDA Warning Letter webpage.

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The Blog is Thankful

Thanksgiving is my favorite holiday. It’s always a good thing to be thankful for the many blessings we have. It is also a good thing to be thankful on a full stomach. I’m thankful of life in general. I’m thankful I earn a decent living. I am very thankful that I have decent healthcare although I would be more thankful if others had the same. I’m also thankful for each person who visits this site. If you’ve read this far, thank you. If this is your first visit, please explore a little. I think there are some interesting things posted here and there.

Have a wonderful holiday season, whichever holidays you choose to celebrate. The Blog will be taking a break over the holidays to catch up on paperwork and to enjoy time with family and friends. I’ll see you in 2010. Cheers!

thank⋅ful  [thangk-fuhl]
–adjective
feeling or expressing gratitude; appreciative.
Origin: before 900; ME; OE thancful.

FDA Food Safety Bill Advances

FOOD SAFETY UPDATE: Check out the website “FDA, Food Safety, and Related Topics” on the link below. Also, Sid’s book reviews on the page above. Also, the new FDA WL page next to Sid’s book reviews.

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Congress is moving forward with a bill that will increase FDA’s authority and funding to conduct food safety inspections. Most of us would agree that’s a pretty good idea. With a globalization of the food industry and E. coli becoming a household word, one would wonder why it has taken so long. Well, food is Big Business and there are a lot of the proverbial “special interests” interested in what a food safety bill will or will not allow FDA to do. The current Senate bill is a result of a lot of compromise. Enough concessions were made to allow wide bipartisan support in a political climate where the word “bipartisan” is considered by many to be an obscenity.

The bill, Senate 510, authored by Senators Dick Durbin and Tom Harkin, Chair of the Senate Health, Education, Labor and Pensions Committee, has major bipartisan support as well as support from many food companies and food trade organizations. Republicans are on board including Senator Mike Enzi of Wyoming, the Republican committee leader, who asked for quick approval of the bill. “I’m hoping the bipartisan approach will continue right on through the floor work,” he says.

Unfortunately, the bill doesn’t receive the support of small, local farmers. The San Francisco Chronicle’s newsblog reports that “Small farms and the sustainable agriculture movement raised alarms today about Senate legislation that they say would stifle family farms with ‘heavy-handed and costly attempts’ to battle food-borne illness but in fact would reduce the nutritional value of food.” The small farmers who produce the locally grown fruits and vegetables we find at our hometown farmers’ markets say the bill rigs the system in favor of agribusiness.

In addition, amendments were withdrawn that address major food safety issues. Senator Jack Reed of Rhode Island withdrew an amendment that would have addressed many concerns regarding antibiotics in livestock. Committee chairman Harkin said that more study was needed to determine the risks to human health from the non-therapeutic use of antibiotics in livestock.

“Non-therapeutic use of antibiotics?” Why in the world would anyone use an antibiotic for anything but a therapeutic use? Well it seems that this is a widespread practice in the feedlots that give us our T-bones and Big Macs. When livestock live in close quarters at the feedlots, eating out of bunks and not in a natural habitat, then they get sick. And to keep them from getting sick they receive medicated feed loaded with antibiotics.

FDA has long conducted “tissue residue” inspections to keep antibiotics out of the food supply. There is supposed to be a period of time that animals don’t receive antibiotics and other drugs before slaughter, so the drugs don’t end up in your roast beef. Overuse and misuse of antibiotics is one of the more serious public health problems worldwide. Senator Harkin should know that many people are allergic or sensitive to antibiotics. He should also know about MRSA and drug resistant TB. However, there are a lot of feedlots in Iowa, so the good senator seems to have a different risk/benefit assessment from the rest of us. He should read some FDA Warning Letters on the subject. Here is an excerpt from a 2007 inspection in Muleshoe, Texas:

“Our investigation also found that you hold animals under conditions that are inadequate such that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drug from edible tissues.”

That’s dry, technical language that means they may have slaughtered animals too sick to make it to the slaughterhouse. I’ve heard stories about animals being helped in with a forklift from some Vet Med inspectors I used to work with. This Warning Letter cited a number of drugs in slaughtered animals and it isn’t an isolated circumstance. Go to the FDA website and search for Warning Letters by subject: “Animals for Slaughter / Adulterated,” and you’ll find page after page of similar violations. I have attached a tissue residue Warning Letter at the top on a new page, “FDA WL.”

The food safety legislation being considered by Congress would give FDA broader authority including the ability for mandatory recalls, trace backs of contaminated fresh produce, funding for more food inspections, and new authority over food imports. I think that’s a good thing. However, we need food safety laws that have FDA focusing on agribusiness and the feedlots, not small farmers. We need a risk-based approach that targets well-documented problems, including the overuse of antibiotics. Anytime you have such widespread support from the giants of the food industry for food safety legislation you should take a closer look. A much closer look.

An exciting time for an FDA job

I received an inquiry about finding a job at FDA this morning. It is an exciting time to be at the Agency with a new commissioner and a new emphasis on public health. I would highly recommend checking it out. The job site is USA Jobs and the basic job title for many FDA jobs, including a field investigator, is “Consumer Safety Officer.” It takes a college degree with 30 units of science (at least it used to). I have placed a link to job announcements on the Blogroll under “1 FDA Jobs.” I enjoyed most of my 17 years there and if you are interested in public health and public service I encourage you to give it your consideration.

Paying for healthcare? “Tax the rich,” AP poll says

Maybe Al Franken is right. The comedian turned liberal lawmaker raised some eyebrows when he joined conservative Republicans in opposing taxes on medical device manufacturers to pay for healthcare reform. It turns out that an AP poll finds that most Americans also have a different idea on how to raise funds. They agree with Franken on device taxes. Instead, they want to tax the rich (what a novel idea). Here’s what AP says:

“Lawmakers also are looking at levying new taxes on insurance companies, drug companies and medical device makers. But the only approach that got majority support in the AP poll was a tax on upper-income Americans. The House bill would impose a 5.4 percent income tax surcharge on individuals making more than $500,000 a year and households making more than $1 million.”