Statin Insanity
The medical student was confused. "Well, that's not good."He was seeing, in black and white, the benefits and harms of statin medicines. After years of systematic inculcation about the power of cholesterol reduction, this was the first time he had seen the numbers."I don't get it. I thought cholesterol was the big player in heart attacks."Not really. Three-quarters of people having a first heart attack, for instance, have normal cholesterol levels."Seriously?"Indeed. In fact, 50 years ago during the Framingham Heart Study, researchers first suggested that cholesterol may be a weak risk factor for heart disea...
Source: PharmaGossip - November 16, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Big Pharma waves the shroud
Too many drugs being blocked from NHS, say pharma giantsNine of the world’s biggest pharmaceuticals companies have demanded an overhaul of NHS processes that they claim are damaging the “health of the British public and wealth of the British economy”.In a joint letter to The Telegraph, the drugs giants, including Pfizer, Sanofi and Novartis, have warned that new and innovative medicines are being blocked from the health service by “overly complicated” approval processes and a heavy emphasis on cost control.They claim that the National Institute for Health and Care Excellence (NICE), the body that selects drugs fo...
Source: PharmaGossip - November 15, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Chicago Said to Weigh Suit Over Marketing of Painkillers
Lawyers for the city of Chicago are investigating marketing claims by producers of narcotic painkillers as a prelude to a possible lawsuit against them, according to interviews and a court filing.The investigation is focusing on whether manufacturers of the drugs, which are known as opioids, overstated their benefits and understated their risks, such as the chances that a patient could become addicted to the drugs, a court filing shows.Should the inquiry determine that the companies made false claims, the city would then seek to recover millions of dollars in health care dollars spent on pain drugs used to treat city emplo...
Source: PharmaGossip - November 15, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
BMJ - Hidden Data Putting GlaxoSmithKline to the test over paroxetine
Cite this as: BMJ 2013;347:f6754Child and adolescent psychiatryChild and adolescent psychiatry (paedatrics)More topics ArticleRelated contentRead responses (1)Article metricsPeter Doshi, associate editorAuthor Affiliationspdoshi@bmj.comBlockbuster antidepressant paroxetine is no stranger to headlines. The drug is now back centre stage as requests for clinical data from one of its trials are testing manufacturer GlaxoSmithKline’s commitment to full transparency, Peter Doshi reportsWhen the Journal of the American Academy of Child and Adolescent Psychiatry(JAACAP) published study 329 in 2001,1...
Source: PharmaGossip - November 15, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Dendreon makes more staff cuts
Dendreon Corp., maker of the prostate cancer drug Provenge, said it's making more staffing cuts; this time more than 200 employees will be axed.
The Seattle biotech said it needs to make a 20 percent reduction in staffing from its current approximate 1,050-employee workforce. After the cuts, Dendreon (NASDAQ: DNDN) said it will have about 820 employees. At one time, Dendreon had more than 2,000 employees.
"We are restructuring the company and implementing additional cost reductions to enable Dendreon to succeed as a leaner, more nimble biotechnology company focused in immuno-oncology," said John Johnson, CEO, president and...
Source: PharmaGossip - November 12, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Hip Hip Hooray
Johnson & Johnson In $4 Billion Settlement on Hip-Implant Lawsuits -BloombergJohnson & Johnson ( JNJ ) has agreed to pay $4 billion to settle more than 7,500 lawsuits over the company's recalled hip-implant products, Bloomberg News reported Tuesday, citing three people familiar with the agreement.http://www.nasdaq.com/article/johnson--johnson-in-4-billion-settlement-on-hip-implant-lawsuits--bloomberg-20131112-01471? (Source: PharmaGossip)
Source: PharmaGossip - November 12, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Shire acquires ViroPharma for $4.20 billion
Shire has hit the acquisition trail and is spending $4.20 billion to buy the US rare disease specialist ViroPharma.
The Ireland-headquartered group is paying $50 per share, which represents a 27% premium on ViroPharma's closing share price on November 8. The deal gives Shire access to the hereditary angioedema drug Cinryze (C1 inhibitor [human]), which complements its own HAE drug Firazyr (icatibant).
http://www.pharmatimes.com/Article/13-11-11/Shire_acquires_ViroPharma_for_4_20_billion.aspx? (Source: PharmaGossip)
Source: PharmaGossip - November 11, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Orphan Drugs - The Seattle Times explains
The mining of rare diseasesThirty years ago, Congress acted to spur research on rare diseases. Today, we have hundreds of new drugs — along with runaway pricing and market manipulation, as drugmakers turn a law with good intentions into a profit engine.By Michael J. Berens and Ken ArmstrongHer vision failed first.Then she fell asleep at school from inexplicable fatigue. Even walking proved difficult, often impossible, as she knocked into furniture and walls. It was like an electrical switch in her body toggled without warning. Some days she was in control, most she was not.Specialists were s...
Source: PharmaGossip - November 11, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Does Brilinta's Brilliance Beggar Belief?
The European Medicines Agency is demanding more information from AstraZeneca on its troubled heart pill Brilinta.
This rounds off a tough few weeks for the firm as it comes after the US Department of Justice (DOJ) took the unusual decision to investigate the product in late October.
Neither AZ nor the DOJ have disclosed the exact nature of the investigation, but analysts believe it relates to various aspects of the study that have been criticised by external researchers.
This includes comments from James DiNicolantonio of Ithaca New York, and Ales Tomek of Charles University in Prague, who said in a recent paper that pa...
Source: PharmaGossip - November 8, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
University Researchers Are Seen as Enablers in Latest Major Drug Fraud
By Paul BaskenFederal prosecutors on Thursday concluded another multibillion-dollar settlement with a major pharmaceutical company accused of illegally marketing its drugs.In this case, the company was Johnson & Johnson, the total payment was $2.2-billion, and the key drug was Risperdal, which was approved by federal regulators to treat schizophrenia in adults but was being marketed for other patients, including children with behavioral problems.As with similar instances involving other major drug companies in recent years, the case file includes a list of academic researchers who wrote articles for medical journals th...
Source: PharmaGossip - November 8, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Shire to cut UK research jobs says source
Rumours are growing that Shire will be cutting dozens of research posts at its R&D centre in Basingstoke, Hampshire.
This is according to a source speaking to the Financial Times, who says the Irish-based firm is poised to announce a restructuring programme that will include cutting dozens of research jobs at its headquarters in Basingstoke.
The company’s board has reportedly been discussing ‘substantial cuts’ among its 170 research scientists in the Hampshire town, and a shift in its Swiss office from Nyon to Zug and a refocussing of US operations close to Boston.
In all the Basingstoke unit employs around 50...
Source: PharmaGossip - November 7, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
BREAKING BAD NEWS: Nearly 400 jobs at risk as Novartis consults onclosure of Horsham UK site
Nearly 400 jobs are at risk as pharmaceutical giant Novartis consults on plans to close its Horsham site, off Parsonage Road, it has been revealed today (Tuesday November 5).
The company, still one of the town’s largest employers, said this morning that it will work closely with employees through this ‘difficult time’.
A spokesperson from Novartis said: “Novartis UK is today announcing that it will initiate consultation on proposals to close its Horsham site in West Sussex. These proposals will impact up to 371 roles, but will be subject to an employee consultation process and final UK board approval.
“We unde...
Source: PharmaGossip - November 6, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Ranbaxy whistleblower reveals how he exposed massive pharmaceutical fraud
(CBS News) Among the drugs prescribed to Americans, 80 percent are generic drugs, and 40 percent of drugs are now made overseas in countries such as China and India where U.S. oversight is weaker.
Recently, CBS News' senior correspondent John Millerhas been looking at one of those companies -- Ranbaxy.
Dinesh Thakur, an American-educated chemical engineer, was hired by Ranbaxy, back in 2003. He would later become a whistleblower, exposing massive fraud by the generic pharmaceutical giant, a company that sold Americans drugs like the generic version of Lipitor. His information led to Ranbaxy pleading guilty to seven f...
Source: PharmaGossip - November 6, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
J&J to pay $2.2B to settle Risperdal marketing allegations
Johnson & Johnson has agreed to pay over $2.2 billion to resolve criminal and civil allegations that the company promoted powerful psychiatric drugs for unapproved uses in children, seniors and disabled patients, the Department of Justice announced on Monday.The agreement is the third-largest settlement with a drugmaker in U.S. history, and the latest in a string of actions against drug companies allegedly putting profits ahead of patients.Justice Department officials alleged that J&J used illegal marketing tactics and kickbacks to persuade physicians and pharmacists to prescribe Risperdal and Invega, both antipsyc...
Source: PharmaGossip - November 5, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Yay! $168M payout to Johnson & Johnson Risperdal/Scios whistleblowers. By Gregory Wallace
The $167.7 million award is one of the largest whistleblower awards in U.S. history. It will be divided among an unspecified number of whistleblowers in three states, according to the Justice Department.
The $2.2 billion settlement between Johnson & Johnson and authorities settles charges that J&J marketed drugs for unapproved uses and gave kickbacks to doctors and nursing homes. Attorney General Eric Holder said Johnson & Johnson and two subsidiaries "lined their pockets at the expense of American taxpayers, patients and the private insurance industry."
The settlement addresses both state and federal charges...
Source: PharmaGossip - November 5, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
