Archive for February 9th, 2009

China Makes your Drugs!

February 9th, 2009 | No Comments | Source: NY Times

As discussed in a post earlier today, most drugs consumed by Americans are made in other countries, particularly China and India.

In China’s case, that didn’t happen by fiat. China’s rise to become America’s pre-eminent supplier of prescription and OTC drugs has resulted from explicit government policies, according to Guy Villax, chief executive of Hovione, a drug maker.

Villax shared a document with the New York Times revealing that Shanghai’s provincial government pays local drug producers $15,000 for each drug approval obtained from our FDA and $5,000 for those secured from European Union regulators.

chinesepenicillinfermenter 300x275 China Makes your Drugs!The Chinese government strategy was hatched in the 1980s when it acquired enormous quantities of penicillin fermenters and helped finance production of the stuff on the cheap.

The move “(disrupted) prices around the globe and (forced) most Western producers from the market,” according to Enrico Polastro, an expert in antibiotics who spoke with the Times.

Penicillin is a building block for 2 classes of antibiotics. During World War II, the US military commercialized penicillin production and from that time until the 1980s, most US pharmaceutical companies made the stuff in the US.

The chairman of Cipla, the large pharmaceutical ingredient supplier says his company has become quite dependent on Chinese suppliers.

“If tomorrow China stopped supplying pharmaceutical ingredients, the worldwide pharmaceutical industry would collapse,” Yusuf Hamied told the Times.

Last year’s Heparin scare underscored the problem. In that case, Federal regulators deduced that the blood thinner was the cause of an epidemic of anaphylactoid reactions in dialysis centers.

The regulators determined that US Heparin supplies came from only 2 companies, Baxter International and APP Pharma. Soon thereafter, they deduced that Baxter was distributing a brew that had been contaminated by Chinese suppliers. The Feds promptly took Baxter Heparin off the market.

Problem was, APP got its Heparin from China too.

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Cook in for Jobs at Apple

February 9th, 2009 | No Comments | Source: Fortune

Last month Steve Jobs Who-is-Apple acknowledged that, 5 years after being treated for a rare neuroendocrine tumor of the pancreas, he’s not altogether well.

cookinforjobs Cook in for Jobs at AppleJobs emailed employees to say he’d be taking a 6-month leave from the company. His “health-related issues are more complex” than he’d known previously, and he’s cool with Tim Cook being “responsible for Apple’s day-to-day operations” while he’s gone.

Jobs Who-is-Apple also made it clear he’s coming back and he’s still CEO.

So now Tim Cook, Apple nation turns its lonely eyes to you.  Cook, Apple’s COO, has been running the show for years, but always with Jobs Who-is-Apple there to provide context not to mention the fairy dust.

Most people figured Cook would never cut it as Apple’s CEO, that he was an ops guy and not a visionary like Jobs Who-is-Apple.

But under these circumstances no one makes sense as a stand-in more than the guy who already oversees customer support, sales, the online store, the Macintosh division, and telecom relations not to mention operations.

But can he like, really do it all by himself?

getbettersoonsteve Cook in for Jobs at Apple“The company already has coalesced around (Cook),” a top Apple executive told Fortune, on condition of anonymity.

“Tim does almost nothing that would make you disrespect him, which you can’t always say about Steve,” he added.

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Who Makes Your Drugs?

February 9th, 2009 | No Comments | Source: NY Times

Somewhere between very few and none of the medications consumed by Americans are made here and that’s a problem for some lawmakers. 

madeinchina 300x225 Who Makes Your Drugs?“The lack of regulation around outsourcing is a blind spot that leaves room for supply disruptions, counterfeit medicines, even bioterrorism,” Ohio Senator Sherrod Brown told the New York Times.

Used to be that most of the pills we consumed were made here but just like the production of steel, clothing, TV sets and so forth, pill manufacturing moved to Asia in pursuit of reduced production costs and a—shall we say—more relaxed regulatory environment.

Now virtually all key ingredients for antibiotics and drugs from prednisone to metformin come from India and China, according to the Times.

In fact the FDA reports that only 13% of 1,154 pharmaceutical plants listed in applications for generic drugs were located in the US. Forty-three percent were based in China and 39% in India.

The CDC stockpiles antibiotics in sufficient amounts to treat millions, but if our penicillin supply was snipped for whatever reason or a disaster drained the stash, we would be stuck. It would take 2 years to get a commercial-grade penicillin fermenter up and running.

And there’s essentially no regulatory oversight for the supply-chain. Drug makers are not required to release information about suppliers, and they believe such information is proprietary, so oftentimes it’s impossible to determine where drug ingredients even come from.

The FDA keeps various lists of drug suppliers, but they are neither reliable nor up to date. One database lists 3,000 foreign plants that export drugs or ingredients to the US. Another puts the number closer to 6,800.

No one really knows.

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