Tuesday, April 29, 2008

Report: Risky tests of blood substitutes allowed

The products in question here are very different from each other...

Pooling data would make almost no sense...safety trials would be a good idea, which the FDA strongly recommended, and they enforced their own recommendation...check the timing of Biopure's stock dropping several years ago as compared with the FDA response letter...

other details gets washed over in this article as well...

FDA permitted human testing despite warning signs, report charges

CHICAGO - Experimental blood substitutes raised the risk of heart attack and death, yet U.S. regulators allowed human testing to continue despite warning signs, says a scathing new report.

The U.S. Food and Drug Administration fell short, the report contends, even as red flags popped up during studies by five biotech companies. Rules barred the agency from releasing company trade secrets, and that kept some information hidden and may have led to unnecessary heart attacks and deaths, wrote the authors, who are government scientists and consumer advocates.

“There shouldn’t be secret science,” said the lead author of the report, Dr. Charles Natanson, of the National Institutes of Health Clinical Center. Safety data need “to be made public expeditiously so science can build on the mistakes” of previous research, he said.

link to full article

Saturday, April 26, 2008

Study says near extinction threatened people 70,000 years ago

I find this type of stuff fascinating...

image from National Geographic

WASHINGTON - Human beings may have had a brush with extinction 70,000 years ago, an extensive genetic study suggests. The human population at that time was reduced to small isolated groups in Africa, apparently because of drought, according to an analysis released Thursday.

The report notes that a separate study by researchers at Stanford University estimated the number of early humans may have shrunk as low as 2,000 before numbers began to expand again in the early Stone Age.

"This study illustrates the extraordinary power of genetics to reveal insights into some of the key events in our species' history," Spencer Wells, National Geographic Society explorer in residence, said in a statement. "Tiny bands of early humans, forced apart by harsh environmental conditions, coming back from the brink to reunite and populate the world. Truly an epic drama, written in our DNA."

link to full article

other links

National Geographic- The Genographic Project

IBM- The Genographic Project

Heparin Recall Update

The Chinese delegation visited the Baxter site in Cherry Hill last week...and there hasn't been much follow-up in the press...

It was heard that that the Chinese requested samples of the product in question in order that they can do their own testing in China...and that these samples were provided to them...

Anybody want to guess what the Chinese will report?

At an embassy news conference in Washington, Chinese officials said the problems
linked to heparin could have occurred in the United States, or that chronic
conditions in some patients led to severe reactions.

This is not the statement of a scientific team focussed on identifying the root cause of an adverse event...which is a demanding, difficult task which requires good research, scientific judgement and caution...these things need to be right...

No, this is the type of waffling statement made by organizations trying to duck out on their responsibility...they will say anything in order to shift the blame or to avoid being held accountable...exactly the sort of behavior that can not possibly result in identifying and correcting the current problem...

Thursday, April 17, 2008

FDA suspects heparin contamination due to fraud

The US Food and Drug Administration (FDA) believes that the contamination of Baxter's blood thinner heparin, which has been linked to 62 deaths in the US, may have been due to the deliberate replacement of some ingredients with cheaper alternatives.

Analysis by the agency recently established that the drug lots in question contained oversulfated chondroitin sulphate, which is a less-expensive, animal cartilage-derived alternative to raw heparin that is not approved for use in medicine. Oversulfated chondroitin sulphate has been implicated in causing the hypersensitivity reactions associated with contaminated heparin.

FDA Commissioner Andrew von Eschenbach told the US Senate on Tuesday that the agency suspected the ingredient switch had been made "by virtue of economic fraud," but added that it would leave further investigation of the matter to Chinese State Food and Drug Administration officials.

link to full article

Thursday, April 10, 2008

Lung cancer warning a death knell for inhaled insulin?

You know all those jokes about drugs where the side effectes are worse than the symptoms the product is supposed to help with?

Pfizer has updated the US product labeling of its inhaled insulin treatment Exubera to include a warning of increased risk of lung cancer among those using it.

Warning labels were issued as a consequence of a clinical trial in which 6 of the 4,740 Exubera-treated patients developed lung cancer, as opposed to 1 of the 4,292 patients not treated with Exubera.

The move is the latest twist in the downwards spiral of Exubera, which appears to have taken the whole inhaled insulin market down with it.

Exubera launched as the world's first inhalable insulin and was touted as a potential $2bn a year blockbuster. However, it was dogged by safety concerns, as well as complaints that the device was too expensive and cumbersome, leading to Pfizer abandoning the treatment.

link to full article

Tuesday, April 08, 2008

Alligator blood may put the bite on antibiotic-resistant infections

Who comes up with this stuff?...

NEW ORLEANS, April 6, 2008 — Despite their reputation for deadly attacks on humans and pets, alligators are wiggling their way toward a new role as potential lifesavers in medicine, biochemists in Louisiana reported today at the 235th national meeting of the American Chemical Society. They described how proteins in gator blood may provide a source of powerful new antibiotics to help fight infections associated with diabetic ulcers, severe burns, and “superbugs” that are resistant to conventional medication.

Their study, described as the first to explore the antimicrobial activity of alligator blood in detail, found a range of other promising uses for the gator’s antibiotic proteins. Among them: combating Candida albicans yeast infections, which are a serious problem in AIDS patients and transplant recipients, who have weakened immune systems, the scientists say.

“We’re very excited about the potential of these alligator blood proteins as both antibacterial and antifungal agents,” says study co-author Mark Merchant, Ph.D., a biochemist at McNeese State University in Lake Charles, La. “There’s a real possibility that you could be treated with an alligator blood product one day.”

link to full article

Monday, April 07, 2008

Technique accelerates analysis for 1,000 Genomes Project

The 1,000 Genomes Project is to benefit from a powerful new computational tool which can analyse half a million DNA sequences within ten minutes.

The tool, which uses an innovative statistical technique to analyse genetics data faster and more accurately than previous methods, should allow scientists to detect more subtle genetic variations at a lower cost.

Over the last five years, the experimental technology used to obtain genetic sequences has massively improved. Whereas it took 13 years to obtain the first fully sequenced human genome, scientists now plan to sequence 1,000 more human genomes within the next three years, to find the subtle genetic variations between different human beings.

One of these techniques is pyrosequencing, which provides longer sequences of base pairs (250 compared to 35 with other methods). However, with these new techniques comes an enormous amount of data, so scientists are continually looking for innovative new techniques to analyse the data at a higher speed and to a greater accuracy than ever before.

"We're on the edge of a real technological revolution that I think will help us understand the genetic causes of diseases in humans and how genetic materials determine traits in animals," said Gabor Marth, a member of the 1,000 Genomes Project from from Boston College in the USA. "It is going to lead to less expensive technologies that will allow researchers to decode any individual."

link to full article

link to 1,000 Genomes Project

Sunday, April 06, 2008

Beijing smog may affect athletes

They claim they can regulate smog...

too bad, drug manufacturing must be a little trickier...

But Chinese leaders have made repeated assurances that Beijing's notorious smog will be solved before the Olympic Games begin.

Beijing's heavy pollution may hurt the performances of athletes in this summer's Olympic Games, although it will not endanger their health, International Olympic Committee President Jacques Rogge said Saturday.

The IOC in recent months has acknowledged the possibility that athletes' performances may be affected by China's pollution. But Chinese leaders have made repeated assurances that Beijing's notorious smog will be solved before the Olympic Games begin.

"The health of the athletes is absolutely not in any danger," Rogge said Saturday. "It might be that some will have to have a slightly reduced performance, but nothing will harm the health of the athletes. The IOC will take care of that."

link to full article

Thursday, April 03, 2008

US and Chinese pharmacopoeias expand working relationship

I would like to think that this will help...here's hoping...

The pharmacopoeias of the US and China will work more closely together in future in a bid to improve the quality of medicines available in both countries.

To that end, the US Pharmacopoeial Convention and the Chinese Pharmacopoeia Commission have signed a memorandum of understanding (MoU), to tighten up the physical and documentary standards applied to pharmaceutical ingredients and establish processes to update existing monographs in both countries.

The deal is in response to the globalization of the pharmaceutical market, with drug firms increasingly sourcing ingredients from a wide range of territories.

Such a climate has created the need for greater cross-border collaboration on monitoring and standards. This was highlighted by recent problems with ingredients sourced in China that saw unscrupulous suppliers substitute the excipient glycerin for the toxic compound diethylene glycol (DEG). Since the case emerged, the USP has been working with the Food and Drug Administration's Pharmaceutical Ingredient Safety Taskforce to modify the identification test for glycerine, and to move DEG-specific testing from the impurity analysis section of the monograph to become part of the identity test.

link to full article

Wednesday, April 02, 2008

How to have smarter conversations...

Marc from JNJBTW posted a comment in response to a post the other day about Centocor's new corporate blog with an interesting point about the changing state of our industry as it relates to blogging...

if we are going to really start to understand how the world is changing, we are
going to have to start to be part of the conversation.

I have been puzzling as to what form this conversation is going to take...

Can it be a thoughtful conversation? How many blogs does it take to discuss an entire industry? How far will we get before louder tries to trump smarter?

As usual, there are guidelines for "Smarter Conversations" available from Hugh...

NIH, EU move to ban “brain doping” in academia

This is great...now it's not just the athlete's!!!...the World Anti-Brain Doping Agency!!!...you can't make this stuff up...

To be a cutting-edge scientist, you can’t be a dummy. Now, it would seem, you can’t be a dope.

As many readers already know, the press has been paying close attention to the question of brain-enhancing chemicals among academic researchers — specifically, the ethics of “brain doping,” using compounds that were originally designed as treatment for neurological conditions in order to enhance performance: e.g., using the anti-narcolepsy drug Provigil (modafinil) to extend hours of wakefulness, or taking the anti-hyperactivity drug Adderall (amphetamine) to boost energy levels.

Here’s a quick summary of the most prominent articles from the recent mainstream press:

The Blue Pill Makes you Smarter (NPR)
Professor’s Little Helper (Nature)
Brain-Boosting Drugs Hit the Faculty Lounge (Chronicle of Higher Education; n.b. the reader comments on the same page)
Brain Enhancement Is Wrong, Right? (New York Times)
Office Pill-Popping (Wired; this piece is not about academia but raises similar issues in the broader working world)

Now, in answer to these concerns, the NIH and its European equivalents have moved to block the use of brain-enhancing drugs among any individuals or institutions accepting federal money to fund their research. The effort is being spearheaded by a multinational agency, the World Anti-Brain Doping Agency (WABDA), which will “to help individual academic federations implement testing procedures in the fields of academic research.

link to full article

link to Ouroboros blog

Tuesday, April 01, 2008

Spit tests may soon replace many blood tests

Not too soon for me...

Easy-access body fluid may provide less invasive diagnosis thanks to proteomics
One day soon patients may spit in a cup, instead of bracing for a needle prick, when being tested for cancer, heart disease or diabetes. A major step in that direction is the cataloguing of the “complete” salivary proteome, a set of proteins in human ductal saliva, identified by a consortium of three research teams, according to an article published today in the Journal of Proteome Research. Replacing blood draws with saliva tests promises to make disease diagnosis, as well as the tracking of treatment efficacy, less invasive and costly.

link to full article