Friday, May 30, 2008

Mrs Friday's favourite

Quote of the week

"You make a pill for a nickel and sell it for four dollars. Those economics can overcome some management incompetence."

Mike Krensavage

Schering Plough - Remicade: show us the model

In the UK NICE has recommended two anti-TNF treatments for ankylosing spondylitis, the painful and progressive rheumatic disease, but has excluded a third because of cost effectiveness.

Wyeth's Enbrel and Abbott's Humira were recommended by NICE, but it ruled that Schering-Plough's Remicade was too expensive for use on the NHS.

Enbrel and Humira can both be injected at home, and cost around £10,000 a year, but Remicade has to be given via a drip in hospital, pushing the cost above £15,000.

NICE says patients currently receiving Remicade, will be allowed to keep taking the drug until they and their clinicians decide it appropriate to stop, but no new AS patients should be given the drug.

Schering-Plough, along with the National Ankylosing Spondylitis Society, has been fighting the decision since last year when the initial decision was announced, but NICE has now issued its final ruling.

But after having their appeal rejected, Schering-Plough could be set to exploit a new avenue opened up by Eisai's battle with NICE over Alzheimer's drugs.

The Court of Appeal recently ruled that NICE must allow Eisai access to a previously confidential economic model.

In similar circumstances, Schering-Plough was not granted full access to the economic model used for the TNF drugs. It says it is disappointed that what it has seen of the economic modelling it finds 'highly unsatisfactory'.

Schering-Plough says that in the light of the Alzheimer's ruling, it will be writing to the NICE to request a fully-executable version of its model for review.
More at Pharmafocus

Photoshop and Science - oil and water

Kristin Roovers was a postdoctoral fellow at the University of Pennsylvania with a bright career ahead of her—a trusted member of a research laboratory at the medical school studying the role of cell growth in diabetes.

But when an editor of The Journal of Clinical Investigation did a spot-check of one of her images for an article in 2005, Roovers's research proved a little too perfect..........

Favrille - Specifid: they make it personal!

Favrille, the San Diego biotechnology company, is laying off 132 of its 144 employees, including six of its eight executive officers. The move comes after the company announced this week that it had discontinued development of its lead drug, Specifid, after it failed to show benefit in a Phase 3 clinical trial in non-Hodgkin lymphoma.

"Coercive Democracy" - McClellan and Olbermann

The Huff Po reports.

Advertising - the good old days!

Lilly - Zyprexa: sweet dreams

Eli Lilly said on Thursday a long-acting form of its schizophrenia drug Zyprexa will likely become available in the United States in the "near future," based on favorable signals from U.S. regulators.

Chief Executive John Lechleiter said Lilly's optimism is based on recent meetings between the company and the Food and Drug Administration, which in February had rejected the injectable form of Lilly's biggest-selling medicine.

The FDA, in issuing its "not approvable" letter, had said it needed more information to better understand the risk and underlying cause of excessive sedation seen in about 1 percent of patients given the injectable formulation in clinical trials.

More at Reuters

Thursday, May 29, 2008

Bettye Lavette - Let Me Down Easy

For Ed at Pharmalot. He's met her you know!

Taro and Sun call it quits

One year ago, India's Sun Pharmaceutical had signed an agreement to acquire Taro Pharmaceutical Industries for $454 million. The latter company is a US-based generic drug maker and, after many delays in the acquisition, Taro finally terminated the deal altogether.

The Indian company's loss is being compared to the MTN-Bharti merger that recently fell through. Sun Pharma is one of the largest Indian drug manufacturers and this latest merger would have been a boon for the growing company. Taro's decision is reportedly based on the company's financial turnaround in the past year. Apparently, Taro's advisors at Merrill Lynch also recommended that the company back out of the deal.

Taro has reported a profitable quarter -- the third in a row. It would seem that the company doesn't need Sun Pharma anymore. Where does this leave Sun? Since the deal was conditional from the beginning, the larger company has no legal recourse in this case. Sun will walk back into the sunset, tail placed firmly between legs…

By Heather Johnson.

Heather is a regular commentator on the subject of CNA Programs. She welcomes your feedback and potential job inquiries at heatherjohnson2323 at gmail dot com.

Chantix - found in the ad agency's wastebasket

Photo: Will Sherman -

Insider's take: Start prescribing again when Pfizer can claim "Chantix - the pilots' choice!"

Vytorin's decline continues

Hat tip.

Euro Commish consultation on Big Pharma "info"

The pharmaceutical industry is not an appropriate source of general information on prescription medicines to the public, mainly because of potential conflicts of interest relating to financial matters, according to nearly half the responses to the European Commission’s now-completed public consultation on the provision of medicines information to patients.

Responses received from health care professionals and payers were “mostly suspicious” of drugmakers as information suppliers, while those from media, patient information organisations and the industry itself were generally supportive. A significant minority suggested that, if there was a clear distinction between advertising and information, companies would be a valuable source of such information because they know the product.

Most responses agreed that drugmakers should be allowed to publish on their websites Summaries of Product Characteristics (SPCs) and patient information leaflets (PILs), for example. However, many of then, especially from health professionals and regulators, were apprehensive that manufacturers could focus this information on newer products, because they would have stronger economic interests in doing so. “Information about ongoing studies shall by no means be communicated to the public, as they are likely to create massive uncertainty in patients,” the Commission adds.


Propaganda and psychiatrist's perceptions

The prescription habits of psychiatrists are strongly influenced by pharmaceutical "propaganda", a leading expert in the field has claimed.

Psychiatrist David Healy, writing in the latest issue of Psychotherapy and Psychosomatics, was commenting on a paper by Harvard researchers which looked at the psychology of risk and prescriptions of psychotropic drugs.

He said the current "crisis" in psychiatry stemmed from a combination of a lack of independent study, a lack of independent access to what data are available, and an "unsophisticated" interpretation of that data.

He said it was important that clinicians understand the dynamics that impinge on their judgement as it is "almost certainly the case" that pharmaceutical companies engineer clinical perceptions based on side effect profiles.


It's free!

Shame it's not available in the UK.

GSK - Seroxat / Paxil: study 329 dissected by Healthy Skepticsm

GlaxoSmithKline’s Study 329 of medication for adolescent depression failed to demonstrate any benefit for paroxetine over placebo in adolescents and demonstrated a worrying profile of adverse events for paroxetine.

The study was ultimately published in 2001 by the Journal of the American Academy of Child and Adolescent Psychiatry with Keller as the primary author. This misleading paper has been a focus of interest for Healthy Skepticism since 2002. In 2003 they wrote to the Editor of JAACAP raising concerns about the misleading reporting by the authors that exaggerated benefit and downplayed adverse effects. (They also questioned editorial functioning, which drew an angry response from the Editor).

In 2004 CMAJ published an Editorial which showed that in 1998 an internal GSK document clearly acknowledged that GSK were aware that 329 was negative. A subsequent law suit by New York Attorney General, Eliot Spitzer, was settled out of court.

In 2006, HS wrote to the Lancet to point out that internal documents from another United States law suit (Smith versus GSK) revealed further concerns about study 329:

The study was ghostwritten - see here.

Misleadingly positive interpretations of the study were promoted to drug reps and other GSK staff - see here.

An illusion of efficacy was achieved by re-inventing primary and secondary end points - see here.

Eventually GSK had to acknowledge the failure of all three of their child and adolescent paroxetine depression studies - see here.

Click here for Peter Mansfield's summary of all trials of newer antidepressants in children and adolescents.

Click here for J & E Jureidini's summary of citations of the Keller paper.


Wednesday, May 28, 2008

John McCain and Mark Salter

McCain's own words:

I read my e-mails, but I don't write any. I'm a Neanderthal -- I don't even type. I do have the rudimentary capability of calling up some Web sites, like the New York Times online, that sort of stuff. No laptop. No PalmPilot. I prefer my schedule on notecards, which I keep in my jacket pocket.

But my wife has enormous capability. Whenever I want something I ask her to do it. She's just a wizard. She even does my boarding passes -- people can do that now. When we go to the movies, she gets the tickets ahead of time. It's incredible.

My most valuable resource is my chief of staff and writing partner, Mark Salter. We've been together for 17 years. I cannot imagine my professional life without him. When we're writing a book or speech, he'll come in to the office in the afternoon or evening with a tape recorder. We talk about the outline, then the details of it, then get into the minutiae. He writes most of it, and then we go over it together.

It's the perfect partnership, with him doing most of the work. He's a remarkable man. I gave a speech on the floor of he Senate to wrap up the debate on the torture amendment. It was the only time when there was total silence on the floor of the Senate. We wrote that together.

GSK - clinical trials, ain't they a bitch?!

GlaxoSmithKline's Promacta, an experimental platelet-boosting drug, did not help control bleeding any better than a placebo, a U.S. Food and Drug Administration reviewer said in documents released on Wednesday.

"The data provided in this NDA (new drug application) do not demonstrate statistically significant, robust ... treatment effect in decreasing bleeding events," the reviewer wrote.

More at Reuters

Insider's view: So, why submit the NDA?

NICE extend simvastatin use

The UK's National Institute of Health and Clinical Excellence has published new guidance for the month of May.

The published guidance includes Clinical Guidelines that cover Lipid Modification and an update to the Type 2 Diabetes Guideline.

The former guideline (Quick Reference PDF) provides advice for risk management by lipid modification in patients at high risk of cardiovascular disease and those who have already had a cardiovascular event or have cardiovascular disease. This guideline has been reported in the general media (BBC) due to the prediction that an additional 1.5 million people could be prescribed a statin.

The update to the Diabetes guideline (Quick Reference PDF) covers:

Lifestyle Management
Appropriate use of self monitoring of blood glucose
Blood pressure targets and management
CVD Risk prediction
Lipid targets and management
Eye, Kidney and Nerve Damage

Simvastatin 40mg is the recommended first line therapy for all patients. There is no recommended target for primary prevention and moving high intensity statins is not recommended as routine.

Hat tip: Matt

Plavix / Aspirin combo application pulled

European regulators have revealed that Sanofi-Aventis and Bristol-Myers Squibb have withdrawn a marketing authorisation application for a drug which combines the blockbuster Plavix with aspirin.

The European Medicines Agency said it had been formally notified by the firms’ decision to withdraw its application for DuoPlavin (clopidogrel/acetylsalicylic acid), which was expected to be used by patients already taking clopidogrel (Plavix) and acetylsalicylic acid (aspirin) for the prevention of atherothrombotic events in acute coronary syndrome. The application was submitted to the EMEA on May 30 and was under review by the agency's Committee for Medicinal Products for Human Use (CHMP).


RIP Sidney Pollack

Director of "Three Days of the Condor".

Today's Condor.

Blogging religiously?

How big is the hole Big Pharma is in?

Go here to find out.

Meet Amy Schulman - Pfizer's new top lawyer

She says:

Many successful women have become successful because they're just awfully good at being compulsive and organized and doers. But it's hard to be successful and be a control freak, because if you cling to things, you're going to be a bottleneck. Delegating to other people -- appropriately delegating -- is very liberating. There isn't anybody on my team I don't trust 100 percent. Remember, I've been building this team for ten years.

I have two assistants now. I have an assistant from 7 in the morning till 4 in the afternoon, and then an assistant from 4 to midnight. I wake up somewhere between 5 and 6 A.M., and get to the office about 8, before the phone calls start. On the days that I'm not traveling -- I travel probably 50 percent of my life -- I try to get home by 7:30 P.M. I typically don't sign off e-mail until midnight.

I get around 600 e-mails a day. I divide them into four categories, and I deal with them immediately, by and large. First are e- mails that I forward to someone else. Next are where somebody's giving me information that I need to cascade to somebody else with instructions. Third are the ones that I can read later on an airplane. Fourth are those that require me to respond immediately.

I used to have two cell phones because coverage is erratic. I decided one service provider worked best here and the other there. At some point I decided that was insane.

I don't leave my cell phone on. I'm often in meetings or with clients, and I don't want people to assume that they can dial my cell phone and get me, unless it's an emergency. You can't leave it on if you're in a meeting with the CEO or a witness. It's really important to focus on the problem at hand. You get into a rhythm of a conversation, and you have to honor that rhythm. People get anxious when they feel they're going to be interrupted. What a good lawyer brings to a problem, in addition to creative solutions, is a quality of attentiveness. You can't listen with half an ear.

The BlackBerry was at first a significant intrusion on family life. But my family has gotten used to the fact that I'm more relaxed if I can take care of my e-mails. I don't generally look at my e-mail during mealtimes, and I try not to look at it in movie theaters.

Tuesday, May 27, 2008

My brain hurts

FOX 2 - Trotta's apology


Let the sun shine in!

AstraZeneca and Merck, plus two trade associations (the Pharmaceutical Research and Manufacturers of America and AdvaMed) are the latest groups to give their backing to the revised Physician Payments Sunshine Act concerning gifts to doctors.

A week ago, Eli Lilly became the first firm to back the changes to the bill which raises the payment limit requiring disclosure from $25 to $500, while possible fines have been reduced to $1,000-$50,000 from $10,000-$100,000 for each violation. Now Merck has pledged its support saying it commends the sponsors of the Sunshine Act, Senators Charles Grassley (Republican-Iowa) and Herbert Kohl (Democrat-Wisconsin) for attempting to create “a single, national system for the reporting of information”.

The company’s chief executive Richard Clark said “we especially appreciate that your revised draft legislation does not impose substantial additional burdens on physicians who are already subject to many demands that take them away from patient care”.

AstraZeneca echoed Mr Clark’s sentiments and Tony Zook, president at the firm’s US subsidiary said the legislation “will create greater transparency around our relationships with physicians, while helping the public understand how we work with healthcare providers”.


Olbermann comments on Clinton's use of the word "assassination"



Liz Trotta is the former New York bureau chief of The Washington Times and a contributor for FOX News.

"Emerging Markets"

'Doctors, Drugs and Dinners, how drug companies influence health in the developing world.'

Introducing Epi Wonk

Epi Wonk (that’s me) has a Ph.D. in epidemiology. I worked for more than 30 years as a professor in medical schools and schools of public health and as a senior epidemiologist at the CDC. I have been the editor of three medical journals. I am now retired.

Welcome to the Yobbosphere.

How many Merck executives does it take to change a light bulb?

Monday, May 26, 2008

Here's Johnny!

Ed has the story

Do you know these gentlemen?

According to these people, you should:
1) Agnes Klein — director of a French radiopharmaceutical company.
2) Clive Savage — director of corporate communication for IMS.
3) Michael Santoro — professor of business, Rutgers
4) Andrew Jack — pharmaceutical correspondent for Financial Times.
5) Andrew Tunnicliffe - editor of “World Pharmaceutical Frontiers”.

Friday, May 23, 2008

Attention alli users!

"Dishes targeted to health-conscious consumers at popular chains such as Chili's, Taco Bell and Applebee's contained as much as twice the calories and eight times the grams of fat than the restaurants claimed in their published nutrition information," reports Isaac Wolf, citing research done in eight cities by television stations affiliated with the Scripps media chain.

The worst offender was the Macaroni Grill, a restaurant chain owned by Brinker International. Its "Pollo Margo Skinny Chicken" was supposed to have 500 calories but actually had 1,022, with 49 grams of fat rather than the promised 6.

"People have a right to know what's in their food," said Margo Wootan of the Center for Science in the Public Interest. "How can you exercise personal responsibility and make an informed choice if you don't have basic information?"

What is it?

Show me the money!

In a sharp reversal, drug and medical device companies are giving more money to Democrats than Republicans this election season, one more sign of the campaign difficulties the GOP could face this November.

Over the past six elections, such businesses typically spent twice as much on GOP candidates; in 2002, the ratio got as high as 3-to-1.

Democrats now are holding the edge with $7.4 million in campaign contributions compared with $7 million for GOP candidates, according to the Center for Responsive Politics, which tracks political spending.

"Money follows the power," said Massie Ritsch, the center's communications director. "And it can predict power."


Corruption in Italy! Pass Insider a chair!!

A drug licences-for-cash scandal has engulfed Italy's medicines regulatory agency with leading officials arrested along with people linked to major pharmaceutical companies.

The most senior figure to have been held is Pasqualino Rossi, vice-president of Aifa (the Italian Agency for Pharmaceuticals). Dr Rossi is also one of Italy's most senior representatives at the European Medicines Agency.

Five drugs company lobbyists have also been arrested, and an eighth person is being sought.

Arrest warrants were issued after Turin's investigating judge Sandra Recchione saw a 400-word police report suggesting money had changed hands in return for the falsification of clinical data required for drug licences.

At the centre of the investigation are licences awarded to around 30 medications, mostly thought to be generic products. The two-year investigation, centred on Turin, Rome (where AIFA headquarters are based), Padova and Alessandria, involved use of wire-tapping, and convert cameras.

The scandal came to light in Turin following the routine comparison of a branded medicine and its generic equivalent. It emerged that the generic drug had undergone fewer tests than were officially claimed and that data endorsing the product had been falsified.

The discovery sparked a major investigation by the city's prosecutor, Raffaele Guariniello. Following the arrests he said: "In this case the corruption and risks to people's health were bound-up together. And the web and the magnitude of events that we're shedding light on have unthinkable and very grave consequences."

Italy's La Repubblica newspaper named the drug giants Bayer and GlaxoSmithKline, as two companies with links to some of the arrestees. Daniele Rosa, a spokesman for Bayer's Italian division said: "The investigation does not concern the behaviour of the company, but alleged behaviour that could be traced back to some collaborators whose behaviour the company has no knowledge of. We will cooperate, as always, with the investigating authorities for everything that will be requested."

Massimo Escani, a spokesman for GSK in Italy, denied that any associates of the company were involved in the scandal. "The claims are completely untrue. We deny any involvement whatsoever. These reports are groundless," he said.

Initially, Aifa issued a brief statement denying that its employees were among those being investigated. When the Italian press named the senior officials arrested, however, the statement was removed from the website and the spokesman said that a new one was being prepared.

Martin Jarvis, a spokesman for the London-based EMEA, said: "We are aware of the reports and we have written to the Italian authorities in order to clarify Dr Rossi's status. Our concern is that he is in a position to perform his duties at the EMEA."

Seroxat / Paxil in children

Published vs unpublished data.

MHRA investigation docs.

Naughtie vs Garnier

A BBC Radio Broadcaster Jim Naughtie recently questioned JP Garnier about the MHRA investigation into the suppression of negative Seroxat data live on Air.

What followed was an astounding and challenging piece of live broadcast journalism .

Thursday, May 22, 2008

Pfizer - Chantix: coffin nails

Sales of Pfizer's quit-smoking pill Chantix are plummeting in the U.S. after regulators tied the drug to suicides, a setback that may further depress shares that reached a 10-year low a month ago.

U.S. prescriptions for Chantix have dropped by almost 33 percent since Jan. 18, when the suicide link surfaced, according to research firm Verispan LLC in Yardley, Pennsylvania. Wary doctors now use the pill only when other treatments fail, said Norman Edleman, chief medical officer for the American Lung Association in New York.

More from the excellent Shannon Pettypiece here

On the road - blogging in Starbucks

What is it?

Pfizer - Sacrebleu, Part Deux!

Pfizer is planning to cut 500 jobs in France by 2011, Les Echos reported Thursday, citing trade union sources.

Pfizer already cut its workforce by 400 last year, the newspaper said.

Evelyn Pringle - Bush's FDA: Big Pharma Insider Information Scam

The steady leaking of insider information about products under review by the FDA has caused enormous losses for average American investors since the Bush Administration took control of the agency six years ago.

There are several ways that investors can profit from this type of insider information. The first is obvious, buy the stock because approval of a product will almost certainly raise a company's stock value. Investors who know about the decision ahead of time can bet the farm based on that information.

But investors who are tipped off that a product will not be approved can do the opposite. They can bet that company's stock value will fall by selling the stock short knowing full-well that the minute the news of non-approval becomes public, the stock's value will drop like a rock.

When the leaking of this type of information occurs, the losers are always the investors who play by the rules and make bets based on the best public information available. Unfortunately, in many instances, these are the very people who can least afford the loss.


Knock knock

Who's there?
JP .
JP who?
That's Big Pharma for you!

Jean-Pierre Garnier's last day as GlaxoSmithKline chief executive was marred by sharp criticism of his tenure at the annual meeting.

Shareholders accused Mr Garnier and his board of underperformance and failing to boost shareholder returns despite billions of pounds of share buybacks.

"I am getting fed up with this underperformance," said shareholder John Farmer to applause. "This board is a continuing failure. You are not a philanthropic organisation; you are here to deliver positive shareholder returns."

More at The Telegraph

Wednesday, May 21, 2008

Pfizer - Chantix: what's your poison?

Pfizer’s smoking-cessation drug Chantix came in for a bit more trouble today, as a research group cited reports of physical side effects associated with the drug. The FAA, which reviewed the report, barred pilots and air traffic controllers from taking the drug, the WSJ reports.

Pfizer's smoking pill Chantix has been linked to more than 3,000 reports in the U.S. of serious side effects, including suicides, heart trouble and aggression, the study said.

Those findings should prompt the U.S. Food and Drug Administration to implement stricter warnings on the pill, prescribed about 3.5 million times in the U.S. in its two years on the market, according to a report released today by the Institute for Safe Medication Practices, which analyzed complications reported to the FDA.

Attention academics!

An integral, yet harrowing, part of being an academic is producing publications. The process follows a predictable formula:

1. You are inspired by a wonderful and creative research idea.

2. You painstakingly collect every bit of research that has been written on the topic.

3. You develop a brilliant and novel means of testing your research questions.

4. You deal with IRB, grant-giving institutions, and other red tape hurtles.

5. You run models, interview subjects, analyze data, etc.

6. You sit down at the computer to write up your findings.

About one year later, you emerge with a masterpiece final draft, ready to send off to some lucky journal. And this is where the nightmare really begins (oh, and you thought you were already there, didn't you?).

Once you are lucky enough to get a coveted R&R, and you get over your initial shock, you realize you actually have to revise. And resubmit. This requires appeasing the editor, and the evil Triad known as the Blind Reviewers.

For this, I have devised a cunning weapon: the blind reviewer voodoo doll*

This 9-inch doll (without hair) is lovingly crafted within the Anomie Studio and arrives finished and ready to be put to good use.


*Also useful for envenomed editors, swag-bellied students, and pestilent professors.

FiercePharma's Top 10 Big Pharma CEO paychecks

1. Miles White - Abbott - $33.4M
2. Fred Hassan - Schering-Plough - $30.1M
3. Bill Weldon - Johnson & Johnson - $25.1M
4. Bob Essner - Wyeth - $24.1M
5. Robert Parkinson - Baxter - $17.6M
6. Daniel Vasella - Novartis - $15.5M
7. Richard Clark - Merck - $14.5M
8. Frank Baldino - Cephalon - $13.5M
9. Sidney Taurel - Eli Lilly - $13M
10. Jeff Kindler - Pfizer - $12.6M

Go here to find the other seven who didn't make the cut.

The China Syndrome in reverse?

Joe has a theory.

Wondering what to buy Fred Hassan and Carrie Cox as leaving presents?

How about a cartoon?

Hat tip: PM

More on Pfizer's Corporate Punk Simon Revell

Welcome to the Pharma Yobosphere Simon.

Getting on in Big Pharma?

Daily grind or get bumped?

Anyone being "bumped" in Big Pharma?

'Bumping' - a kind of voluntary demotion - is a new trend in large companies going through restructuring.

But is it legal?

And is it happening in Big Pharma?

More at Pharmafocus

Ernst & Young predict the bleeding obvious

Big pharmaceutical companies' hunger for new products will drive further large-scale acquisitions in the biotech sector, following a record year in 2007, according to a report on Tuesday.

Ernst & Young predicted in its annual global biotechnology survey that the convergence of biotech and pharma industries would continue unabated in 2008 and beyond.

"One or more mega acquisitions of mature biotechnology companies along the lines witnessed with MedImmune -- and nearly seen with Biogen Idec in 2007 -- is likely," the consultancy group said.

MedImmune was bought by AstraZeneca Plc for $15.6 billion last year. Biogen, which has a market value of nearly $19 billion, was also on the block but failed to sell.

The role of mega-deals in the biotech sector has been disputed. Some investors, such as billionaire activist Carl Icahn, believe they can unlock substantial value. But others say smaller deals make more sense for drugmakers.

In practice, the sector is likely to see a combination of both big and small deals.

More from Ben Hirschler at Reuters

Tuesday, May 20, 2008

Merck - Vioxx: now a settlement with the Attorneys General

HARRISBURG, Pa., May 20 /PRNewswire-USNewswire/ -- Pennsylvania, along with 28 other states and the District of Columbia, reached a $58 million settlement, the largest ever for a multi-state consumer protection drug case, with Merck over allegations of deceptive advertising related to the drug, Vioxx.

Pennsylvania will receive more than $2.9 million. Attorney General Tom Corbett said that in 1999, Merck allegedly launched an aggressive and deceptive advertising campaign which misrepresented the safety and improperly concealed the increased risks associated with Vioxx.

"Using Merck's Vioxx, which was a prescription pain relieving drug, carried an increased risk of having a heart attack or another serious cardiovascular side effect," Corbett said. "Merck allegedly knew about this, but continued to misrepresent the safety of their product in their advertisements until they finally admitted that Vioxx caused serious side effects and pulled the product from the market in 2004."

Corbett said that early on, Merck aggressively marketed Vioxx directly to consumers. This practice drove hundreds of thousands of consumers to seek prescriptions for the drug before doctors had a chance to gain experience with it and understand the side effects.

"Consumers need clear information about the risks associated with prescription drugs so that they can make well-informed decisions about their health care," Corbett said. "This settlement addresses all of our concerns and will restrict Merck's ability to deceptively promote any oftheir products."

Corbett also said that Merck allegedly engaged in "ghostwriting" positive articles and studies relating to Vioxx. "Ghostwriting can be a particularly deceptive practice," Corbett said. "Some of these articles looked as though they were being published by an independent doctor or organization, but they were allegedly written by people who worked for, or had some sort of interest, in Merck."

Corbett said that after Vioxx was removed from the market in 2004, morethan 25,000 private lawsuits were filed by consumers who were affected by the product. But, unlike those suits, this agreement will force Merck to change their practices.

As part of the settlement, Merck has agreed to:

-- Pay $58 million to the states involved.

-- No longer engage in "ghostwriting."

-- Refrain from using scientific data deceptively when marketing to doctors.

-- Delay any direct-to-consumer television advertising for a pain medication if recommended by the FDA.

-- Submit all television advertising campaigns to the FDA before release for review and to adhere to any recommendations by the FDA.

In addition to Pennsylvania, this settlement includes Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Nebraska, Nevada, NewJersey, North Carolina, North Dakota, Ohio, Oregon, South Carolina, SouthDakota, Tennessee, Texas, Vermont, Washington, Wisconsin and the Districtof Columbia.

The agreement was filed in Commonwealth Court by Chief Deputy Attorney General Thomas M. Devlin and Deputy Attorney General Nicole L. VanOrder of the Attorney General's Health Care Section.

EDITOR'S NOTE: For a copy of the agreement, contact the Attorney General's office at 717-787-5211.

CONTACT: Eric Shirk
Assistant Press Secretary 717-787-5211 (Cell) 717-480-0224

Biovail - a case of hubris?

Biovail's plea bargain doesn't just close an ugly chapter in the Toronto-based company's history.

It also pulls the rug out from under a multiyear quest by the company's former management, led by onetime CEO Eugene Melnyk, to blame an alleged conspiracy of hedge funds and research analysts for Biovail's financial and legal woes.

Roddy Boyd in FORTUNE has more.

Amy MacDonald - This is the life

For DKR.

Honey, what are you doin'?


Hat tip:

Condi must go

Sign up:

Vytorin - The Truth

....according to Condor.

Clinical papers - the ties that bind

Introducing was created in 2007 on the premise that cost should never limit access to effective medical treatments. Originally designed for seniors approaching the Medicare Part D "doughnut hole," it explores cost-effective options to brand name medications. The recommendations are based on clinical experience and pharmaceutical studies.

During the last twenty years, drug costs for American seniors have increased by nearly 400% and in 2006 alone, pharmaceutical sales approached $700 billion. Patients assume that these increased costs directly translate into increased effectiveness. Sometimes they do. But all too often they don't. Instead, patients pay more for fewer side-effects, more convenience, or, worst of all, a medication that is no better at all, but has been effectively marketed to their physician.

So today the question often becomes "What are you buying?" was created to answer this question. For commonly prescribed prescription medications, you can find reasonable alternatives at lower costs. Many of them are generic options that are just as effective and easy to take as the brand-name medication. Others are equally effective but may come with more side-effects or less convenience. Still others are slightly less effective, but at a dramatically lower cost. Never stop or change your medication without talking to your doctor, but ask whether the Medsane Choice might be a better choice for you.

Welcome to,

Zach Flake, MD

So, farewell then, Jean-Paul Garnier

Jean-Pierre Garnier, the GlaxoSmithKline chief executive, probably expected an easy ride when he appeared on Radio 4's Today to puff the firm's anti-bird flu vaccine.

He didn't get it.

James Naughtie laid into an increasingly furious Garnier about the criticism that GSK came in for over Seroxat, the antidepressant drug linked to suicides among children. “Does this mean that all the information GSK holds on the development of Seroxat (aka Paxil) will be put in the public domain?” Naughtie asked. This comprised “millions of documents, millions”, Garnier countered, saying that all had been made available to watchdogs.

Naughtie pressed him further.
“I'm not interested in answering this question. We've dealt with this subject. Thank you for taking the time to hear about the [bird flu] pandemic.” And Garnier was off. It might not have helped that Naughtie referred to a man who clearly takes himself very seriously as “Jean-Paul Garnier”.
Garnier hands over the helm to Andrew Witty at Thursday's AGM.

Monday, May 19, 2008

Neil Diamond gets a UK #1 after 42 years

Pretty Amazing Grace.


More from the concert here.

Bless you

Allergy UK, the country's leading national medical charity for dealing with allergy, will be introducing an Allergy Screening service from 19th May, to coincide with National Allergy Week.
The pharmacy based service will be offered initially in 51 of 152 Primary Care Trusts areas in England before being rolled out to the rest of the UK.


PharmaGossip readers - have your say

Read this first.

Do Consumers Understand Drug Ads?

Sunday, May 18, 2008

Pharma Payola - time for a change of tune?

"Virtually all physicians in America take cash or gifts from the drug companies," says Melody Petersen, author of Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs, and a former New York Times reporter.

"A recent survey said 94 percent of physicians took something of value from the drug companies. Some doctors take hundreds of thousands of dollars a year from these companies, and there's no law that says they can't."

Petersen says she "had no idea this was so extensive until one day I was writing a story about Celebrex and Vioxx -- this was before Vioxx was taken off the market. The story was about the marketing battle between these two pain drugs. I called one of the large societies of rheumatologists and asked for an expert on arthritis. I specifically said I needed an expert who was not being paid as a consultant to one of the manufacturers of these drugs. A staff person said, 'We have lots of people you can talk to, but all of these doctors are consultants to one or both of the drug companies.'"

Drug companies hire doctors to give lectures, and they hire other doctors as "consultants" to go to fancy dinners and listen to the lectures. "There are more than 500,000 of these dinners or events in America every year," Petersen says.

"Radio disc jockeys can't take cash from music companies. But when it comes to something like medicines -- which mean life or death for people -- doctors can take as much money as they want from the drug companies. We need a law to stop that."


Pfizer's DIGWWW

Scott Gavin, Bill Thompson (BBC journalist), Pfizer's "punk" Simon Revell

Pfizer's punk - Simon Revell

Say "Hi" to "punk" Simon Revell. Simon is 'Manager of enterprise2.0 technology development' at Pfizer. In this role he has the remit to explore the potential for using web2.0 inspired technologies and approaches for internal use within the company. Simon has responsibility for the Pfizer-wide wiki, 'Pfizerpedia', as well as development of standards and guidelines around the use of blogging for internal communication and collaboration purposes, and implementation of RSS within the company. He is involved in a number of projects designed to apply enterprise2.0 technologies within specific business lines and functions, and is involved in exploring and evaluating the next wave of enterprise2.0 products inspired by the success of web-based services such as and Facebook.

Early in 2006 Simon started the Discussion Group about the World Wide Web (DIGWWW), a Pfizer internal community of practice that was interested in how the technology that supports collaboration on the World Wide Web could be used to create collaborative environments within Pfizer. It began in the UK, under Simon's leadership, and has since grown into a global activity with enthusiastic participants at all Pfizer R & D sites and across all lines.
Simon's vision is one whereby the company's information and knowledge will be unlocked through easy-to-use enterprise2.0 systems. Simon has been in the IT industry for 15 years, starting as a software developer and later graduating to being a Technical Team Leader and Project Manager. He is based in the UK.

Friday, May 16, 2008

For JP Garnier

I'll let Ed explain.


Up to 32,000 Big Pharma jobs could be axed in France over the next few years, according to a study commissioned by Leem, the French pharmaceutical industry body.

The Arthur D. Little study names five major factors threatening the pharmaceutical model: pricing pressures; generics; changing areas of growth, the break up of the traditional value chain as a result of the rise of biotechnology; and the internationalisation of competition.


Cancer - Big Pharma's last goldrush contd.

The global market for cancer drugs will grow twice as fast as that for all other pharmaceuticals as the developing world spends more on health care, a new report says.

China, Brazil, Russia and other emerging countries are becoming bigger customers for pharmaceuticals as they invest more in treating and diagnosing cancer, according to a report issued Thursday by IMS Health.

The health care research firm expects pharmaceutical spending in countries such as India, Mexico and Turkey to grow by 12 to 13 percent over the next 15 years, compared with single-digit growth for more developed nations.

Cancer drug spending is expected to grow between 12 and 15 percent annually through 2012 to $75 to 80 billion, according the report. The overall drug market is expected to grow at 6.4 percent.


Anal leakage

The "ins and outs"!

Today's Spitzer moment - Thar she blows!

Kristen resurfaces - NY Post was there!

Thursday, May 15, 2008

Placebo TV #12

Go Doug.

Boehringer Ingelheim - clinical trials, ain't they a bitch?!

Said through gritted teeth:

"We are proud to have sponsored the PRoFESS study," said Dr. Thor Voigt, Senior Vice President, Medicine and Drug Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc.

"We set out to advance the understanding of strategies for recurrent stroke prevention and will continue to evaluate the PRoFESS data to help physicians make more informed treatment decisions."

The Trial:

PRoFESS (Prevention Regimen For Effectively avoiding Second Strokes) was designed to examine the effects of different prevention regimens on recurrent stroke, including the antiplatelet agent AGGRENOX versus clopidogrel and the efficacy of MICARDIS, an antihypertensive, compared to placebo in preventing recurrent stroke in the presence of background standard antihypertensive therapy. The trial was a randomized, double-blind, placebo-controlled clinical study that included 20,332 patients from 695 sites in 35 countries, with a four-year follow-up of patients.

PRoFESS is a collaborative effort between academia and the sponsor, Boehringer Ingelheim. Co-funders of the telmisartan arm of the study in selected countries are Bayer Schering Pharma and GlaxoSmithKline.

The Results:

Read them and weep - if you work for BI, that is!

Boehringer Ingelheim just blew up not one, but two of their own drugs with one trial !

Bad day, huh?

Hat tip: The Caped Crusader

Cancer - Big Pharma's last goldrush contd.

Forbes' Matt Herper explains Pfizer's latest ambition.

Dr Adriane Fugh-Berman has been busy

Bottom line - although it has been argued that prescription tracking benefits public health, data gathered by Health Information Organizations is designed for marketing drugs. These data are sequestered by industry and are not generally available for genuine public health purposes.

Bayer - Trasylol: the bitter end

"Thus, in all likelihood, this is the end of the aprotinin story," Dr. Wayne Ray and Dr. Michael Stein of Vanderbilt University.

Who moved my cheese!?

Actor Dennis Quaid told Congress on Wednesday that taking away the right to sue pharmaceutical companies would turn consumers into "uninformed and uncompensated lab rats."
"Like many Americans, I believed that a big problem in our country was frivolous lawsuits," Quaid testified. "But now I know that the courts are often the only path to justice."

New rules for Big Pharma

According to Michael Steinberg in Seeking Alpha:

The FDA is not looking favorably on me-too drugs.
The FDA is requiring “outcomes” based clinical testing, with exceptions only for critical need.
Foreign countries are not allowing patent extensions for minor product life cycle changes.

EU antitrust probe widens

European antitrust investigators are expanding the scope of a major inquiry into the €484 billion pharmaceutical market in a bid to determine whether companies are blocking generics makers from getting less-expensive medicines to market quickly.

Lawyers and European Union officials said Neelie Kroes, the European Union competition commissioner, was also casting her net widely in a bid to determine whether drug companies' efforts to block competitors by extending patents were also distracting them from developing new medicines, which have been slow in coming to market in recent years.

Investigators, who questioned about 100 companies early this year, including Pfizer, GlaxoSmithKline and Sanofi-Aventis, are now turning to about 80 medical organizations, including associations of doctors, patients and pharmacies, and government agencies that set the prices of prescription drugs in Europe. That could make it the broadest antitrust investigation ever in the EU.


Wednesday, May 14, 2008

Tuesday, May 13, 2008

Hank McKinnell keeps on truckin'

Angiotech Pharmaceuticals, a global specialty pharmaceutical and medical device company, today announced the appointment of Dr. Hank McKinnell to its Board of Directors.

Dr. McKinnell is the former Chief Executive Officer and former Chairman of the Board of Directors of Pfizer Inc.

He is currently Chairman of the Accordia Global Health Foundation, an organization dedicated to fighting infectious diseases in Africa, and the Lead Director of the Board of Directors of Moody's Corporation.

Are the Republicans on drugs!?

"The change you deserve."

AstraZeneca - Toprol XL: clinical trials, ain't they a bitch!

AstraZeneca's Toprol XL, given before surgery to prevent heart complications, increases the danger of stroke or death, researchers said.

The researchers studied 8,351 patients at risk for cardiac complications who were having an operation that didn't involve the heart. While the drug reduced the chance of a heart attack, the increased possibilities for death and stroke may outweigh its usefulness, they said in The Lancet.

``Our results highlight the risk in assuming a peri- operative beta-blocker regimen has benefit without substantial harm,'' authors led by researcher P.J. Devereaux from McMaster University in Hamilton, Ontario wrote. ``Patients are unlikely to accept the risk.''

More at Bloomberg

Monday, May 12, 2008

US SEC charges three Fla. doctors in trading case

The U.S. Securities and Exchange Commission on Monday said it has charged three Florida doctors with illegal insider trading, including a board member at pharmaceutical company IVAX Corp.

The SEC said Zachariah P. Zachariah (pic), an IVAX board member, began illegally trading in the company's securities only minutes after he learned that IVAX might be acquired.

The agency also charged Zachariah's brother, Mammen Zachariah, and his friend, Sheldon Nassberg, with engaging in illegal insider trading in the stock of an unrelated company, Correctional Services Corp, around the same time as the IVAX trading.

More info.

Peter Libby MD explains why he stopped "ghost-talking"

Some leading medical experts have decided to end an age-old tradition — taking money from drug companies. These doctors used to get paid for making speeches. But they say they're reclaiming their tarnished credibility.

Madeleine Brand talks to Peter Libby, chief of cardiovascular medicine at Brigham and Women's Hospital in Boston, about his decision.

Dr. Libby has disclosed that he has served as a consultant for AstraZeneca Pharmaceuticals LP; AtheroGenics, Inc.; Boehringer Ingleheim; Bristol-Myers Squibb Company; GlaxoSmithKline; Interleukin Genetics; Kowa Research Institute; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Pfizer Inc; Sanofi-Aventis; and Schering-Plough Corporation. He has participated in Speakers Bureau activities for AstraZeneca Pharmaceuticals LP; Bristol-Myers Squibb Company; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Pfizer Inc.; and Sanofi-Aventis.

Listern here.

You will have heard this melody

But never played more beautifully.

Paul Gregory plays Gran Vals by Francisco Tarrega.

Physician, Heal Thyself

Did you know that 60% of doctors today are dissatisfied with their practice of medicine? Our first feature length film is borne out of the dark frustrations of a Boston doctor who refused to ignore that, every day, we are losing good doctors.

Dr. Ryan Flesher’s raw and unscripted look at himself and his own place in medicine provides a unique revelation that our modern day healers have long held silent. Being a physician today carries a complexity and responsibility, known only to those whom are expected to tend to the ills of society. But when doctors are suffering themselves - who really cares? We are all patients and come the day that we allow for money to supersede humanity, we all become collateral damage.

Dr. Flesher, driven by the altruism that brought him into medicine, with camera in hand, will pull back the curtain. In so doing, he becomes both observer and participant in this unique exploration into the psyche of physicians today.

Heal Thyself

GSK - this old heart of mine

The multinational drugs company GlaxoSmithKline (GSK) downplayed an early warning about the rising number of people who have suffered heart attacks after using one of its drugs, abacavir. An anti-Aids medication, abacavir is taken by tens of thousands of people worldwide.
GSK was officially told of the possible risk in May 2005, three years before it issued a statement to its investors saying that the findings of an even stronger potential link between heart attacks and abacavir are "unexpected" and "unconfirmed". The company also said that it could find no association between abacavir use and heart attacks following a trawl through its internal data. However, it failed to mention that its own summary of product characteristics issued when the drug was launched in the late 1990s had described "mild myocardial degeneration" in mice and rats given the drug for two years.

Some scientists monitoring the safety of Aids drugs are privately furious with GSK for downplaying the significance of one of the biggest safety trials of abacavir – one of several anti-virals taken by Aids patients in combined HIV therapy – when the findings were published last month.

"GSK was extraordinarily well prepared in terms of a statement that downplayed the significance of the findings," said a scientist close to the safety study. "As a consequence, people are confused. They think there is something wrong with the study because GSK said it cannot find evidence to support findings of a link with myocardial infarction [heart attack]."

More at The Indy

Sunday, May 11, 2008

Paradoxical pharmacology?

Insider is interested!

China's heparin suppliers - under the red flag!

The Food and Drug Administration is withholding a list of Chinese heparin suppliers requested by congressional investigators looking into problems with tainted supplies of the blood thinner, saying confidentiality agreements prevent release of the companies' names.

Members of Congress also are concerned that Chinese heparin manufacturers and their raw-material suppliers didn't fully cooperate with an FDA inspection team in February, after the heparin crisis erupted internationally, and barred the FDA from complete access to some workshops, records and workers.

An FDA compliance official testified to a congressional subcommittee April 29 that the FDA could try to revisit facilities in China, but said, "I cannot say whether they will admit us or not, or whether they will allow us to do a full inspection."

Tensions between congressional Democrats and the FDA over the agency's handling of the heparin problem and its willingness to disclose information have escalated in recent weeks.
"The FDA thinks they have it under control, but they really don't," said the congressman leading the investigation, Rep. Bart Stupak (D., Mich.). The FDA's reluctance to release the Chinese companies' names is a red flag, he said. "If I was the FDA director, I'd shut down every drug coming in from China" until they were deemed safe, he said.

Big Pharma's Big Problem contd. - Now the WaPo weighs in

Big pharma needs a miracle drug. The major drug makers are so beaten down that in some instances dividend yields, rather than the next blockbuster drug in the pipeline, are what are propping up the stocks.

Take Pfizer. At its May 7 close of $19.92, the stock is off 28% since last June and is 60% below its all-time high, set in 1999.

Talk about a lost decade.

More at the WaPo.

The Post-American World

A great read.

Sub Prime Humor

A 45 page slide show.

Abbott - Norvir: some weekend reading

Back in April, we at the Prescription Access Litigation (PAL) blog asked “What is Abbott trying to hide?” in a blog post about drugmaker Abbott Laboratories’ efforts to keep documents from reaching the public in a class action lawsuit challenging Abbott’s unconscionable 400% price hike for its HIV/AIDS drug Norvir.

I’m pleased to report that the Court in that case recently ordered that some of the documents be made available to the public.

PAL have just posted those documents in their entirety on the PAL blog, in an entry titled “What Abbott was Trying to Hide - Court unseals Norvir documents.”

Saturday, May 10, 2008

Pfizer - Lipitor: going down

Sales of Lipitor dropped more than £50 million in England last year, as the blockbuster cholesterol drug fell victim to aggressive cost cutting by Primary Care Trusts (PCTs).

The decline in Lipitor is especially significant because it is the surest sign yet that PCTs have seized control of the primary care prescribing budget, and are now dictating the market to GPs and pharmaceutical companies.

Sales of Lipitor (atorvastatin) from GP prescribing fell £53 million in 2007 compared to the previous year, representing a very substantial 15% decline for the UK's biggest selling drug.