Monday, March 31, 2008

More on the Heparin Saga

Chinese quality stinks!!! Chinese drug regulation stinks!!!


"issued a plea"...

"safeguarding the legality, quality and safety of active pharmaceutical
ingredients (APIs)" is ultimately the responsibility of the importing

These people are unbelievable...

China's drug regulatory authority is finally responding to curb its damaged reputation by urging its local authorities to take a more proactive role in stemming what is fast becoming a global heparin contamination, sparked by material sourced in the country.

According to Chinese media reports, the State Food and Drug Administration (SFDA) issued a message on its website urging its regional offices to boost their supervision of the production methods of heparin manufacturers in their locality.

The watchdog has also urged heparin producers to source their raw heparin from registered suppliers only, and issued a plea to heparin manufacturers to ensure they are producing the material in accordance with the approved standards.

In addition, the SFDA warned manufacturers that they must take the initiative to closely follow the clinical effects of their products that are on the market and if any problems are linked back to their manufacturing facilities, they must halt production immediately and recall any implicated products from the market.

Moreover, the agency told raw heparin suppliers to tighten their management and quality checks of raw and supplementary materials. The SFDA's latest actions indicate a softening of the stance on drug exports from the country that it took this time a month ago, when it effectively sent out a message to the world of "buyer beware".

link to full article

Doctors wary after cholesterol drug flop

I like the carefully worded, carefully considered conclusion provided by the lead researcher...

"no result — zilch. In no subgroup, in no segment, was there any added benefit"

I guess Big Pharma wants another blockbuster...I also guess they're busted...

CHICAGO - Leading doctors urged a return to older, tried-and-true treatments for high cholesterol after hearing full results Sunday of a failed trial of Vytorin.

Millions of Americans already take the drug or one of its components, Zetia. But doctors were stunned to learn that Vytorin failed to improve heart disease even though it worked as intended to reduce three key risk factors.

"People need to turn back to statins," said Yale University cardiologist Dr. Harlan Krumholz, referring to Lipitor, Crestor and other widely used brands. "We know that statins are good drugs. We know that they reduce risks."

The study was closely watched because Zetia and Vytorin have racked up $5 billion in sales despite limited proof of benefit. Two Congressional panels launched probes into why it took drugmakers nearly two years after the study's completion to release results.

link to full article

Tuesday, March 25, 2008

Where to Eat

Some places to eat while you're in Town...


Steve's Cart- corner of 17th and Ludlow- on the plaza of the old United Engineer's Building- my daughter's favorite restaurant

Tony Luke Jr's- 118 S 18th St- in between Chestnut and Sansom- grab a scrambled egg and pork roll sandwich for breakfast (with hot sauce...if you need to wake up)

Lunch- Casual

Hot Tamales- a quick bite- Mexican style

Steve's Cart- again

Hard Rock Cafe- it's louder in Philly

Dinner by yourself

Tony Luke's- a South Philly original- get a real cheesesteak!!!

Dinner with a Client

Morton's- a favorite

The Capitol Grille - right downtown

Shula's- eat a BIG steak

Tequila -very nice, worth the cab ride

McCormick and Schmick's - also nice


Tir Na Nog - right down the street from the Convention Center

The Irish Pub- a classic Philly spot

Something Else to do...

if you're looking for something else to do in Philly...

(other than Interphex)...

We recommend the Rodin Museum located out on the Benjamin Franklin Parkway

Join us for Breakfast

ISPE Joint Chapter Breakfast at Interphex

Who: Delaware Valley, New Jersey, and Great Lakes Chapters of ISPE

What: Breakfast Meeting and Presentation

Where: Philadelphia Marriott

When: 27Mar08- 7-9 am

Why: because you get up really early in the morning when you sleep in a hotel

The topic will be an Overview on Sustainable Design and LEED presented by Terry Jacobs, and How Does LEED Affect Your Project from the CM Perspective presented by Rick Warhall and Jonathan Hess of Whiting Turner.



Sunday, March 23, 2008

Has Biotech gone the way of Big Pharma?

Think Big Pharma has problems with their pipeline?...

Check out this report recently published by Ron Rader of the Biotechnology Information Institute

The report focuses on recent approval trends for biotech products with current approval data thru 2007...and, quite frankly, the news is not good...

Ron is also publishing reports detailing industry information for the biotech market sector...

Saturday, March 22, 2008

The Heparin Saga expands...

B. Braun Medical issues recall of heparin

B. Braun Medical Inc. recalled heparin blood thinner in the U.S. and Canada after learning that it contained a "heparin-like contaminant" from a supplier linked to deaths and allergic reactions in another company's product.

The contaminant was supplied by Scientific Protein Laboratories, Irvine-based B. Braun Medical said Friday. Scientific Protein also supplied Baxter International Inc. with heparin containing a cheaper ingredient from China.

Baxter's heparin has been linked to serious allergic reactions and 19 U.S. deaths. The heparin recalled by Braun is sold to hospitals as a premixed solution in intravenous drip bags, a Food and Drug Administration spokeswoman said.

Neither Braun nor the FDA was aware of anyone sickened by the recalled heparin.

link to full article

Wednesday, March 19, 2008

Contaminant found in heparin

WASHINGTON - U.S. health officials have identified a contaminant in batches of the blood thinner heparin associated with 19 deaths and are trying to determine how the chemical got into the drug.

The lots of heparin, whose key ingredient was imported from China, were recalled Feb. 28, and Food and Drug Administration officials said Wednesday that no new deaths have been reported since that time.

Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said the contaminant is oversulfated condroitin sulfate, a chemical that does not occur naturally.

Condroitin sulfate is a natural compound that occurs widely and is used as a dietary supplement but the oversulfated version has not been widely studied.

"We cannot rule in or out whether this was accidentally or deliberately introduced into the product," Woodcock said, "We are investigating how it got in."

The FDA has also initiated testing of imported heparin entering this country and Woodcock said the agency feels "doctors and patients now can be confident that the product on the market has been tested and is safe."

link to full article

Tuesday, March 18, 2008

Stem-Cell Therapy in China Draws Foreign Patients

Let's hope quality problems aren't happening in these circumstances...

China is gaining popularity among a new breed of travelers: patients with incurable conditions who are visiting the country to receive experimental stem-cell treatments not offered in the United States.

One company is now claiming a medical breakthrough, advertising that its treatments are restoring vision to blind children. It has ignited a firestorm of controversy in both China and in the U.S.

full story on npr

Monday, March 17, 2008

New Corporate Pharma Blog- Centocor

Corporate blogs are still few and far between...especially corporate blogs in the Pharm Bio market sector...

Check out CNTO411...Centocor's corporate blog...

Even though some voices in the blogosphere are bouncing around some negative comments about corporate blogging, Centocor should be applauded for their efforts...

Will they find it difficult?...maybe

Will it be worthwhile?... it might not seem so at first

Will they drop the effort if it doesn't appear to produce observable results?...hope not

for an explanation of the purpose of corporate blogging-(and an explanation of the odd little cartoon at the top of this post...)
click here

hint- it has to do with a porous membrane

Friday, March 14, 2008

The Madness continues...

Get your bracket filled out now...

the original WSJ post is here...

with some additional comments from Derek's piepline here...

Thursday, March 13, 2008

Scientists simulate pandemic influenza outbreak in Chicago

Blacksburg, Va. – By using computer simulations and modeling, an international group of researchers including scientists from the Virginia Bioinformatics Institute (VBI) at Virginia Tech’s Network Dynamics and Simulation Science Laboratory (NDSSL) have determined how a pandemic influenza outbreak might travel through a city similar in size to Chicago, Ill. This information helped them to determine the preferred intervention strategy to contain a potential flu pandemic, including what people should do to decrease the likelihood of disease transmission.

The new results, based on three different computer simulation models, are described in a paper published in the Proceedings of the National Academy of Sciences by scientists involved in the Models of Infectious Disease Agent Study (MIDAS).* MIDAS is a collaboration of research and informatics groups supported by the National Institutes of Health (NIH) to develop computational models to examine interactions between infectious agents and their hosts, disease spread, prediction systems, and response strategies.

The global epidemic of avian influenza in bird populations, as well as the risk of a virulent form of the bird flu virus being transferred to humans, has made influenza pandemic preparedness a top public health priority in the United States, Europe, and other countries. The great influenza pandemic of 1918 resulted in 40 to 50 million deaths worldwide. If a pandemic were to occur today, it could cause widespread social and economic disruptions.

link to full article

Finally, a reason to start drinking alcohol

As if you needed one...

WASHINGTON (Reuters) - People who do not drink alcohol may finally have a reason to start -- a study published on Friday shows non-drinkers who begin taking the occasional tipple live longer and are less likely to develop heart disease.

People who started drinking in middle age were 38 percent less likely to have a heart attack or other serious heart event than abstainers -- even if they were overweight, had diabetes, high blood pressure or other heart risks, Dr. Dana King of the Medical University of South Carolina in Charleston and colleagues found.

link to full article

Tuesday, March 11, 2008

March Madness...

It's that time of year again...only in Philly...


March 26-28...

Thursday, March 06, 2008

The Baxter Heparin Saga...pick your spin...

There are a lot of different ways to look at this issue...

- Writer's Scare Tatics..."Tampering possible in China"

- Troubleshooting drug safety is scientific challenge...heparin-like molecules

- FDA and manufacturer cooperate to maintain drug supply...Earlier this month, the firm stopped production, but the FDA wanted to keep the existing Baxter heparin in doctors' hands because it did not want to cause a shortage of the life-saving drug. Agency officials said increased production by the other heparin manufacturer can now satisfy the demand.

- FDA doesn't inspect overseas manufacturing sites...The FDA has averaged just 15 inspections in China in each of the last five years

- Lack of FDA oversight on imports...Flood of drugs, little oversight by regulators

- Outsourcing causes quality problems...Baxter’s Heparin Problems May Have China Connection

- Chinese quality control...Baxter tests point to Chinese problem

- Realtime crisis management...Call to action at Baxter

Manufacturer intitiates recall...Baxter Issues Urgent Nationwide Voluntary Recall of Heparin

Before you decide on which drum you think should be beat on, just remeber that these issues are harder to solve than you might think...