Showing posts with label AstraZeneca. Show all posts
Showing posts with label AstraZeneca. Show all posts

Monday, July 22, 2013

GSK's China Crisis spreads

While the move comes amid a criminal investigation into GlaxoSmithKline, AstraZeneca said it does not believe it has yet been caught up in the maelstrom surrounding its rival.
Officers from the Public Security Bureau arrived at Astrazeneca's sales office in Citic Square, Shanghai, on Friday afternoon and were said to have detained one employee.
"We believe that this investigation relates to an individual case and while we have not yet received an update from the Public Security Bureau, we have no reason to believe it is related to any other investigations," said a spokesman for the pharmaceutical company.
The company added that it "does not tolerate any illegal or unethical conduct in our business activities."
The move comes after Chinese authorities appear to be widening their probe into drug pricing beyond GlaxoSmithKline.
Two sources also said that Baxter International, a US pharmaceutical company, is also under investigation for possible malpractice at its joint venture in China: Baxter Qiaoguang Pharmaceutical.
One source said the investigation may relate to payments paid to secure the approval of Baxter's ClinOleic treatment on the list of products that can be claimed on national insurance. A spokesman for Baxter in China did not respond to requests for comment.
UCB, a medium-sized Belgian pharmaceutical company with a particular strength in epilepsy treatment, said last Thursday its office in Shanghai had been visited by officials from the State Administration for Industry and Commerce (SAIC) seeking information on compliance. At the time a number of other international firms, including AstraZeneca, denied any knowledge of being investigated.
The New York Times reported that it had seen documents showing that at least six other global pharmaceutical companies, including Merck, Novartis, Roche and Sanofi, had used the same travel agency as GSK to make bookings for events and conferences.
While the documents do not indicate wrongdoing, they suggest that the investigation into GSK may widen further.
Meanwhile GlaxoSmithKline, which has been ensnared in a criminal investigation in China for some weeks, has admitted that some of its executives appear to have broken Chinese law.
Abbas Hussein, GSK's head of emerging markets, conceded that a number of senior staff in China had circumvented the drug maker's compliance systems and were in breach of the country's bribery laws.
"Certain senior executives of GSK China, who know our systems well, appear to have acted outside of our processes and controls which breaches Chinese law," Mr Hussain said in a statement.
Mr Hussain, who was dispatched to China by GSK chief executive Sir Andrew Witty on Friday to lead negotiations with the country's powerful Ministry of Public Security, described the talks as "very constructive".
In an olive-branch offering, the pharmaceuticals group has pledged to lower its drug prices in China. Sources close to the investigations say Sir Andrew also has plans to visit China to support the government's efforts to root out corruption in business.
"Savings made as a result of proposed changes to our operational model will be passed on in the form of price reductions, ensuring our medicines are more affordable to Chinese patients," said Mr Hussain.
The Chinese Ministry of Public Security said Mr Hussain had apologised for the scandal. In a statement, it also urged GSK to take "responsibility" for the scandal, citing Mr Hussain's comment that the four detained Chinese executives from the drugmaker were able to break the law because they knew the company's internal systems so well.
Mr Hussain's statement comes as the company's internal probe uncovered evidence that appeared to support some of the allegations from Chinese police, as the Daily Telegraph reported on Saturday.
The drug maker is facing a mounting crisis in China after the country’s authorities revealed police were looking into deals worth 3bn renminbi (£320m), which could go back as far as 2007.
The allegations centre on GSK’s use of “travel agencies” in China which organise conferences for doctors and are a highly competitive business.
The Chinese authorities claim the company used some 700 agencies as middlemen to funnel money to health officials and doctors in order to win market share and clinch higher prices. GSK believes the figure is far lower and says it only has relationships with between 20 and 25 agencies.
Four senior staff, all Chinese nationals, are under arrest, and one appeared to make a public confession on state television last week. Chinese police claim the others have also confessed to the charges.
A British consultant who specialises in fraud investigations in China, and is believed to have advised GSK in the past, has also been detainedas part of the probe.

Sunday, September 04, 2011

Why all the secrecy around the proposed Seroquel settlements?

Compared to this:

http://www.officialvioxxsettlement.com/calculator/

Could it be that the lawyers and AstraZeneca have something to hide?

Maybe a little bit of sunshine on the Seroquel proposals, including comparisons with Vioxx, Avandia, Zyprexa PhenFen etc. might help the people who have suffered?

Wednesday, July 13, 2011

Slumdog Clinical Trials contd. - Fault Lines - Outsourced: Clinical trials overseas


US Pharmaceutical companies have moved their operations overseas over the course of the past decade. Instead of testing trial medicines on Americans, more and more of these tests are being carried out on poor people in faraway places. Russia, China, Brazil, Poland, Uganda, and Romania are all hot spots for what is called clinical research or clinical trials. Now employing CROs—or Clinical Research Organizations—the industry is big business, worth as much as $30 billion US dollars today.

One country has experienced a boom like no other in this industry--India. Spoken English, an established medical infrastructure, welcome attitudes toward foreign industry and most importantly legions of poor, illiterate test subjects that are willing to try out new drugs have transformed the Indian landscape into a massive testing ground for pharmaceuticals. Fault Lines' Zeina Awad travels to India to see what the clinical research practices look like on the ground. What role are the US regulatory bodies playing in overseeing the trials? Are participants aware that they are taking part in a clinical trial? Is the testing being held up against international ethical standards?

http://english.aljazeera.net/programmes/faultlines/

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With over a billion residents, India is one of the growing destinations for the multi-million industry, Wired reports. Clinical research organizations cite the country's enormous population as the main reason for its appeal for clinical tests, but al Jazeera's current affairs show Fault Lines wonders if India's growing gap between rich and poor doesn't complicate that P.R. picture.


Hat tip: HuffPo

Sunday, December 19, 2010

AZ's Brennan speaks! Pass me the bucket (of money)



Bucket story

The Seroquel story

Question 1. How much did Dave Brennan know about "The Seroquel Issue" at the time?

http://pharmagossip.blogspot.com/2009/10/astrazeneca-to-pay-520-million-to.html

The pharmaceutical company AstraZeneca said Thursday (29/Oct/09) that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel.

One of the investigations related to “selected physicians who participated in clinical trials involving Seroquel,” AstraZeneca disclosed in a government filing. The other case related to off-label promotion of the drug.

H. Waxman's letter:

http://oversight.house.gov/Documents/20070305175741-03469.pdf

The Zoladex issue:

http://www.justice.gov/opa/pr/2003/June/03_civ_371.htm

Question 2

What do you think Corporate Integrity Agreements are?

http://oig.hhs.gov/fraud/cia/agreements/AstraZeneca06042003.PDF

This might help.

http://peterrost.blogspot.com/2007/04/secret-astrazeneca-audio-tapes.html

http://peterrost.blogspot.com/2007/04/open-letter-to-oig-from-astrazeneca.html

Question 3

Is Dr Michael Reinstein one of the Seroquel investigators under investigation by the DoJ?

http://pharmagossip.blogspot.com/2009/11/dr-michael-reinstein-clozaril-king-is.html

Today's question (4):

Was Geoff Birkett the "man behind the curtain" in the Seroquel Scandal?

Someone has to take the fall Dave!

http://www.chicagotribune.com/health/chi-drugs-seroquel-reinsteinnov11,0,6067737.story



Last question, for now:


If you or AZ or anyone have any issues of fact about any of this then please say and it will be changed/removed. If not, the so be it!

Thursday, November 11, 2010

When a health provider betrays a trust it must take aggressive steps - including apologies - to regain the consumer’s high regard.


Christiane Truelove writes: So I decided to ask Earl how a pharma company can win back the trust of patients and consumers with such seemingly damning evidence of corporate perfidy constantly circulating around the Internet, just a Google search away.

His answer was, “By the overall actions of the company,” the good stuff that they do, their transparency, etc.

Guess what: That’s not working. Think about it, folks – when someone betrays you in some way (whether they meant to or not) and then showers you with attention and love but never acknowledges the betrayal in the first place, are you won over?

If the burn is minor, you might forgive them in time, but the bigger the hurt, the more impossible it becomes to forgive. So when someone posts on Facebook or Twitter that a drug hurt them or a loved one, or points to seeming evidence of coverups, the carefully crafted corporate platitudes aren’t going to cut it.

They’re not cutting it now. They will never cut it.

Ignoring the query or accusation won’t help either, because social media being a public arena, everyone else can see that you are ignoring the person (even though you may have reached out privately, if you don’t say publicly that you have reached out, it leaves a bad taste in onlookers’ mouths. People take conversations offline all the time, but if the conversation was a public argument, letting others know that you’re trying to be adult about the situation wins points in your favor and can defuse people from jumping into the fray).

In the end, pharma efforts on social media would go over better if they sounded a lot more human. (For more thoughts in this vein, you can see my editorial in the November issue of Med Ad News.)

Saturday, November 06, 2010

Dr Melissa DelBello speaks, but this time it's on YouTube


Sen. Charles Grassley's hall of shame: The chairman of the Senate Finance Committee raised the case of Dr. Melissa DelBello, a psychiatrist who got hundreds of thousands of dollars in travel expenses, consulting fees, and lecture payments from AstraZeneca. DelBello also happened to be lead author of a study that concluded kids did well on AstraZeneca's antipsychotic med Seroquel.

Here's the timeline: DelBello authored the study, published in 2002. In 2003, she got $100,000 from the drugmaker, or so she told the University of Cincinnati. In 2004, she reported $80,000. AstraZeneca's figures total $238,000.

Grassley was pretty peeved not only about the apparent conflict of interest--which AstraZeneca denied; DelBello wasn't available for comment--but also by the fact that DelBello also got NIH funding during the same period. University of Cincinnati said it applauds Grassley's "looking into this very important issue."


Read more: Seroquel researcher got cash from AZ - FiercePharma http://www.fiercepharma.com/story/seroquel-researcher-got-cash-from-az/2008-04-08#ixzz14TRkOmDR
Looks like Melissa is now also getting money from Lilly :  

http://projects.propublica.org/docdollars/payments/557430

Sunday, October 24, 2010

Quick! Stop the clinical trial; we've got a p value!


Gordon Guyatt, MD, epidemiologist, internist, and biostatistician at McMaster University updates us on the progress being made against the problem of clinical trials being stopped early to inflate efficacy of drugs. Since our first coverage of the topic two years ago, the FDA, the Cochrane group, and other agencies have implemented changes in policy.  Dr. Guyatt discusses the Crestor JUPITER trial as an example of a trial that was stopped early and inflated efficacy.
Click here for the video interview