Andrew Witty – window dressing at Glaxo… but where’s the real transparency?

Andrew Witty’s latest initiative at Glaxo is no more than window dressing as he promises to make public the level of advisory fees it offers to doctors and medical academics (Charlie Nemeroff anyone?).

If Witty really wants transparency, then I ask him to give me an hour of his time and we’ll talk Seroxat/Paxil – I live near Brentford so I can work around your diary, Andrew.

One blunt Yorkshireman to another, eh lad?

Anyway, this from Pharmalot:

Andrew Witty wants to board the transparency train. After a few rival drugmakers – such as Lilly and Merck – vowed to disclose payments to doctors, Glaxo is now saying it will do the same.

And so the ceo promises to make public the level of advisory fees it offers to doctors and medical academics, and will strictly cap the payments they can receive in the US to $150,000 a year, according to The Financial Times. He tells the paper that he will impose a cap “without exception” on payments and promised to publish the amounts. Although, a timetable has not been revealed. [Our thought: $150,000 is a lot of money, Andrew. Why so much?]

The move comes after Glaxo has been caught up in pair of publicized debacles. In the US, Charles Nemeroff received about $1 million in payments from Glaxo, and is being investigated by the US Senate Finance Committee for failing to make sufficient disclosure while accepting federal grants to reseach Glaxo drugs. He recently stepped down as chair of the Emory University psychiatry department (take a look).

And in the Netherlands, the health inspectorate is investigating concerns about payments from Glaxo to academics who sit on the Health Council, an advisory body that recommended the use of Cervarix, the drugmaker’s new HPV vaccine (back story). Glaxo denies any committing any misconduct.

“It’s appropriate that we have a limit on what we pay. In the past, whatever has happened has happened, but in the future there will be strict adherence to these caps, which will be clearer to everybody,” Witty tells the FT. However, the “timing and infrastructure” of publishing details of its payments had yet to be determined. [Another thought: Why not, Andrew?]

Pharma has taken voluntary steps to limit certain activities that critics say influence prescribing, but in the US, the PhRMA trade group issued guidelines that do not cap consulting or speaking fees (see here).

Jim Thomson and the EAASM – promoting big pharma, not patients

Jim Thomson heads up the European Alliance for Access to Safe Medicines (EAASM). Long-standing readers of this blog will know I am always very interested in what Jim’s up to and I’m a long time critic of the man and what he stands for.

So I was interested to read this from the German newspaper Spiegel Online:

‘Worst-Of’ Awards to Smoke Out EU Lobbyists

[Vote here.]

Brussels is packed with behind-the-scenes lobbyists working hard — and not always cleanly or fairly — to promote their employer’s interests. A group of NGOs is currently trying to bring a bit of transparency to this murky world with some not so honorific honors.

When it comes to lawmaking in Europe, an estimated three-fourths of all new laws and regulations originate in Brussels, the European Union’s capital city. And where the decisions that affect businesses are made, even if you can’t see it, you’re always also sure to find one more group — lobbyists.

Yes, they’re the unsung heroes of the European lawmaking arena. Whether it’s in hidden backrooms, at fancy restaurants or at exclusive parties, they are the faceless individuals working tirelessly — as some see it — to make sure that we are misinformed about major world conflicts, that we pay more to stay healthy and that we have more CO2 to enjoy in our atmosphere.

But now, for the fourth year in a row, a group of four NGOs is giving citizens a chance to recognize these individuals and companies by voting online for the 2008 “Worst EU Lobbying Award” and the “Worst Conflict of Interest Award.”

“There really are no rules in the EU that put any restraints on lobbying,” said Ulrich Müller, a representative of Cologne-based group LobbyControl. His organization has teamed up with three other anti-lobbying NGOs — Corporate Europe Observatory, Friends of the Earth Europe and Spinwatch — to administer the awards and thereby recognize “who deserves to be named and shamed for the most deceptive or misleading lobbying campaign in Brussels.”

This year, five finalists have been chosen for the “Worst EU Lobbying Award” from a pool of 54 nominees. The awards are reserved for those who “pretend to be concerned about environmental activities, who pay off scientists, provide concealed financing to anarcho-capitalist think tanks or secure privileged access for themselves to EU institutions.” This year’s nominees include:

• The Brussels-based PR and lobbying firms GPlus and Aspect Consulting for their roll in “supporting the spread of war propaganda in the recent conflict between Russia and Georgia.” The two companies helped manage the “propaganda war” for the different sides in the conflict, making a killing by keeping the media misinformed and disseminating false information about things such as the number of killed and whether Russian forces were even operating in South Ossetia.

• The agrofuel lobby representing the producers MPOC, Unica and Abengoa for their “misleading campaigns to promote agrofuels as green,” while denying that producing agrofuels from palm oil and sugarcane has any effect on the security of the food supply and the environment.

• The European Alliance for Access to Safe Medicines (EAASM) for “hiding the involvement of big pharma corporations in their campaigns.” The organization — which is funded by pharmaceutical heavy-hitters, including Bayer-Schering, Boehringer Ingelheim, Eli Lilly, Johnson & Johnson, Pfizer and Wyeth — failed to disclose its benefactors when publishing a study that tried to dissuade people from using online discount drug providers.

• The International Air Transport Association (IATA) for its “deceptive lobbying campaign to avoid CO2 reduction obligations in the aviation sector.” According to the award jury, the organization — which lobbies on behalf of aviation giants Lufthansa, British Airways and Air France — successfully persuaded EU representatives to set aviation emission limits using the figures that the lobby had publicized for the industry’s contribution to total global emissions. While the industry persuaded the European Parliament that it was 2 percent, other organizations put the figure at up to 12 percent.

• The European Business and Parliament Scheme (EBPS) for “abusing their location and lobbying from inside Parliament offices.” Among other things, the business association is accused of organizing a gala night for corporate representatives and members of the European Parliament in official buildings.

[Vote here.]

Anyway, for more about Jim and his previous good works please read on:

What a tangled web we weave…

National Depression week 2005…

Depression Alliance…

Yet more on Cymbalta marketing…

Jim used to be Sales and Marketing Director for Innervate. Read more on the links below about this:

Innervate Ltd, Jim Thomson and the Centre for Mental Health

The good works of the Diabetes Monitoring Forum

More Astroturfing?

Choice and Medication website… and another thing

And another thing about that Choice and Medication website – have a look at the section entitled “What sort of side-effects might occur if I am taking SSRIs?”… it’s made up of standard pharma rubbish. And not even up to date standard pharma rubbish:

Nausea and vomiting; restlessness or anxiety; insomnia; headache; rashes and pruritis –
and so the list goes on. Nothing to worry about – it’ll pass – see your Doctor.

Any mention of akathesia, agitation, mania, psychosis, self harm, suicidal thoughts and actions, violence, thoughts of homicide, disturbing nightmares, lack of empathy toward other people, anger, severe memory loss? Nope, I thought not.

Now read this story – from Furious Seasons:

Coroner Blames Celexa For Man’s Suicide

This short article from the UK speaks for itself:

“A postal driver who was prescribed an anti-depressant ‘wonder drug killed himself four weeks later, an inquest heard. Hampstead-born Ian Fox, 65, died in July after throwing himself in front of a train at Finchley Road Tube station. “He had been prescribed the anti-depressant Citalopram [Celexa] for just one month before taking his life and he had expressed a wish to come off it, complaining of confusion and anxiety.

“At his inquest on Thursday, Mr Fox’s wife, Maria Fox, blamed her husband’s sudden death on the drug, and a coroner ruled the ‘adverse effects’ of Citalopram had played a part.

“‘I felt Citalopram was to blame for my husband’s death,’ Mrs Fox told St Pancras Coroner’s Court.

“According to medical research, confusion and anxiety are known side effects in around one in every 100 patients, although it has more generally known for its wonder drug qualities in successful treatments.

“Mrs Fox, from Edgware, said her husband’s action was completely out of character. She described how until he began taking Citalopram he had only been suffering from mild depression, brought on by retirement from his Royal Mail job and a foot injury.

“Coroner Dr Andrew Reid said he accepted that Mr Fox had jumped in front of the train, adding: ‘I’m satisfied he did so while the balance of his mind was disturbed while suffering the adverse effects of Citalopram.'”

Confusion and anxiety are precisely the kinds of side effects of SSRIs that myself and a bunch of other people have been raising a ruckus about for years–and it just staggers me that there are so many doctors who deny that it’s even possible and who don’t warn their patients about this sort of possibility in advance. Yes, I know there are label warnings in the UK (and the US), but doctors have got to reinforce them and get their patients the hell off the drug the minute a problem crops up. It’s one way of avoiding tragedies.

I well know that some people who take SSRIs don’t experience such problems, but such incidents as the above go on far too often for anyone to legitimately claim that there are not serious problems with these drugs.

As we can see, any readers who go to the Choice and Medication website will get the distinct impression there are no serious problems with SSRIs…

The question that must be asked is why would an ‘independent’ website take this point of view?

Why indeed?

Choice and medication… a new ‘independent’ website? – I don’t think so…

I think someone has to ask questions about this new website – Choice and medication.

It has been described thus:

An independent website offering medicines advice for mental health patients was launched at the House of Commons on 10 October, World Mental Health Day.

The website gives patients and their carers advice about more than 100 medicines or medicine groups, with input from a number of pharmacy organisations.

The website has been three years in the making and is a collaboration between the UK Psychiatric Pharmacy Group, the College of Mental Health Pharmacists, the Pharmaceutical Schizophrenia Initiative and the National Institute for Mental Health in England.

Stephen Bazire, author of the site [yeah, right] and chief pharmacist at Hellesdon Hospital, Norfolk and Waveney Mental Health NHS Foundation Trust, said ahead of its launch: “Until now patients very often have had nowhere to go to get this kind of information. They are often ill informed through no fault of their own.

All sounds great until you read about Seroxat and other SSRIs for instance – here’s what the site has to say about:

1 How does Seroxat work?
The brains [sic] has many naturally occurring chemical messengers. One of these are [sic] called serotonin (sometimes called 5-HT) and is important in the areas of the brain that control mood and thinking. It is known that this serotonin is not as effective or active as normal in the brain when someone is feeling depressed. The SSRI antidepressants increase the amount of this serotonin chemical messenger in the brain. This can help correct the lack of action of serotonin and help to improve mood.

2 Are SSRIs addictive?
They are not addictive, but if you have taken them for eight weeks or more you may experience some mild “discontinuation” effects if you stop them suddenly. These do not mean that the antidepressant is addictive. For a drug to be addictive or produce dependence, then it must have a number of characteristics:

* should produce craving for the drug when the last dose “wears off”
* should produce tolerance ie you need more drug to get the same effect
* there should be an inability to cut down or control use
* should produce withdrawal symptoms
* there should be continued use of the drug despite knowing of harmful consequences

Thus antidepressants, if stopped suddenly, may produce some “discontinuation” symptoms but these are more of an “adjustment” reaction from sudden removal of a drug rather than withdrawal.

3 Can I stop taking an SSRI suddenly?
It is unwise to stop taking them suddenly, even if you feel better. Two things could happen. Firstly, your depression can return if treatment is stopped too early (see “How long will I need to keep taking them for?”). Secondly, you might also experience some mild “discontinuation” symptoms (see also above). At worst, these could include dizziness, vertigo/light-headedness, nausea fatigue, headache, “electric shocks in the head”, insomnia, abdominal cramps, chills increased dreaming, agitation and anxiety. They can start shortly after stopping or reducing doses, are usually short lived, will go if the antidepressant is started again and can even occur with missed doses. These effects have been reported for all the SSRIs, but it seems that they occur more often with paroxetine than the others.

Ok then –

1 – is complete bollocks – depression is not caused by a Serotonin imbalance – see here

2 – is simply a lie. It is the default big pharma position to argue the definition of addictive this way. To all intents and purposes, to the man and woman in the street, Seroxat is addictive, as are other SSRIs.

3 – NO, it’s not depression returning – it’s a reaction to stopping the SSRI that is happening. And in all too many cases withdrawal is serious and long lived.

I have to say that Stephen Bazire should be ashamed to put his name to what is nothing more than a piece of marketing for the drug industry and its products.

He didn’t write the site – drug companies wrote the ‘information’ it contains.

“The website has been three years in the making and is a collaboration between the UK Psychiatric Pharmacy Group, the College of Mental Health Pharmacists, the Pharmaceutical Schizophrenia Initiative and the National Institute for Mental Health in England.

The website is supported by a grant from the Pharmaceutical Schizophrenia Initiative (PSI).Five leading pharmaceutical companies make up the PSI, they are AstraZeneca, Eli Lilly, Janssen-Cilag, Novartis Pharmaceuticals UK, and Pfizer.”

This simply cannot be allowed to masquerade as reliable, independent information.

Charles Nemeroff resigns from Emory University – that’s not the end of it though…

So, we say farwell to Chuck “Bling Bling” Nemeroff as he resigns from Emory.

Sorry Chuck, but it’s too little too late. You’ve done the damage already by talking up shitty drugs and crappy research. If you think this is over now, you’ve got another think coming – the time is right to finally bring a so-called Key Opinion Leader to account for his lies. I hope Senator Grassley agrees with me.

If we’re going to put a stop to KOLs selling their reputations to the highest bidders then we need an example to be made of someone. It seems Senator Grassley has the evidence against Nemeroff to do this – does he have the nerve, I wonder?

This from Phil Dawdy at Furious Seasons:

A few of you have probably already caught the news elsewhere: yesterday, Charles Nemeroff resigned as chair of the psychiatry department at Emory University. The move came on the heels of revelations that he’d taken in $2.8 million in pharma consulting monies since 2000, but had only reported less than half of that–all while taking NIH research grants on the other hand and assuring his university that he was taking in less than $10,000 a year in pharma dough.

For those of you who don’t know, Nemeroff is one of the biggest depression researchers in the world and his work is hugely influential in the field. But as CL Psych has repeatedly detailed, Nemeroff’s work is often scientifically compromised.

Emory University has issued a statement:

“Dr. Nemeroff is recognized internationally as a leader in psychiatric research, education and practice. He has made fundamental contributions to the field over many years. The length and complexity of the history outlined by Senator Grassley will require careful review of underlying payment records from the pharmaceutical companies, which we have requested from Senator Grassley’s office. We have also requested that Dr. Nemeroff provide us with relevant information and documentation so that we will have all the facts before us.

“Dr. Nemeroff has assured us that: ‘To the best of my knowledge, I have followed the appropriate University regulations concerning financial disclosures. I have dedicated my career to translating research findings into improvements in clinical practice in patients with severe mental illness. I will cooperate fully and work with Emory to respond to the alleged conflicts of interest issues raised by Senator Grassley and his staff.'”

Whatever, dude.

Read more about all this – here, here and here

Charles Nemeroff caught with his hands in the Glaxo till…

… so says the Wall Street Journal – Senator Grassley is asking ‘Chuck’ Nemeroff some difficult questions about why Nemeroff neglected to disclose certain paments he received from Glaxo… “…From 2000 through 2006, Dr. Nemeroff received just over $960,000 from Glaxo, but reported to Emory University that he received no more than $35,000….”

Oops!

I’ve written about ‘Chuck’ in the past – here, here and here.

This latest story is from DAVID ARMSTRONG of the WALL STREET JOURNAL, October 4:

A prominent Emory University psychiatrist failed to tell the school about $500,000 he received from drug maker GlaxoSmithKline PLC while heading a government-funded research project studying Glaxo drugs, Sen. Charles Grassley alleged.

The payments to Charles Nemeroff, chairman of the Atlanta university’s psychiatry department, compensated him for making presentations to doctors about Glaxo drugs, including its big-selling antidepressant Paxil, according to records Sen. Grassley obtained from Emory and Glaxo. The senator made the allegations in a letter to Emory President James W. Wagner dated Thursday.

In correspondence with Emory officials who police conflict-of-interest issues, Dr. Nemeroff repeatedly denied having a significant financial relationship with Glaxo, according to the records cited by Sen. Grassley, an Iowa Republican who has been investigating ties between academic researchers and the medical industry.

Federally sponsored research, including work Dr. Nemeroff did, is supposed to be free of financial conflicts, but enforcement is generally left to universities, which seldom act against prominent researchers. Emory instructed Dr. Nemeroff not to take more than $10,000 a year from Glaxo — its conflicts threshold — but he exceeded that amount, Sen. Grassley said.

From 2000 through 2006, Dr. Nemeroff received just over $960,000 from Glaxo, but reported to Emory that he received no more than $35,000, the letter said.

Dr. Nemeroff has been in the spotlight before over earnings from the medical industry. In 2006, he stepped down as editor of the journal Neuropsychopharmacology after The Wall Street Journal reported he wrote favorably in the publication about a depression-treating device but didn’t disclose he was a paid consultant to its maker, Cyberonics Inc.

In a June 2004 Emory report obtained by Sen. Grassley, the school concluded Dr. Nemeroff had committed violations of its conflict-of-interest policies. At the time, he had consulting arrangements with about a dozen companies, including Merck & Co., Bristol-Myers Squibb Co. and Eli Lilly & Co.

Sen. Grassley’s probe has alleged discrepancies in reporting by researchers at Harvard and Stanford universities and elsewhere. He has sponsored legislation that would force drug companies and medical-device makers to publicly disclose all payments to doctors.

Dr. Nemeroff served from 2003 until this past summer as the primary investigator on a collaborative grant between Emory, Glaxo and the National Institute of Mental Health, a federal agency. The research effort, called the Emory-GSK-NIMH Collaborative Mood Disorders Initiative, had a $3.95 billion budget from the government, and examined five Glaxo drugs considered for use as possible antidepressants.

In a statement, the NIH said Emory was investigating the concerns raised in the letter and said it “will take all appropriate action to ensure compliance.” The agency said it will also be considering changes to its conflicts policies.

Friday evening, Emory released a statement saying that “in view of the ongoing internal and external investigations into these allegations,” Dr. Nemeroff had voluntarily stepped down as chairman of the department, pending resolution of the issues.

Earlier in the day, Emory called the allegations made by Sen. Grassley “serious” and said it was “working diligently to determine whether our policies have been observed consistently.” Dr. Nemeroff didn’t return a call to his office. The university said he has told the school that “I have followed the appropriate university regulations concerning financial disclosures.”

Glaxo said it has “rigorous guidelines governing our interaction with healthcare professionals” who speak at its events, and requires them to “proactively disclose” these relationships.

The senator alleges Dr. Nemeroff didn’t report that he was giving promotional talks for Glaxo regarding Paxil. When questioned by Emory officials, Dr. Nemeroff apparently failed to report all of his ties with Glaxo’s speaker’s bureau, the Grassley letter said, citing an Oct. 1, 2003, email in which Dr. Nemeroff described his outside activities to the school:

“I have to dig up the agreement and send it to you, GSK no standing contract, I chair their ad board 2-3 times per year and I am paid per board meeting at a standard rate of $5K per weekend.”

However, Sen. Grassley said records show that in 2003, Dr. Nemeroff was an active member of Glaxo’s speaker board and was paid $119,000 in fees and expenses. The senator alleges Dr. Nemeroff didn’t report that he was giving promotional talks for Glaxo on Paxil and another drug, Lamictal, a medication often used to treat bipolar disorder.

On March 19, 2004, the senator said, Dr. Nemeroff addressed questions from Emory’s Conflicts of Interest Committee in a letter in which he wrote: “Apart from speaking at national symposia, such as the American Psychiatric Association, for which GSK might serve as a sponsor, my consultation to the company is limited to chairing their Paroxetine Advisory board and for that, I am remunerated $15,000 per year.” Paroxetine is the chemical name for Paxil.

Just three days earlier, however, Glaxo paid Dr. Nemeroff $3,500 for a talk he gave on Paxil in Orlando, Fla., Sen. Grassley alleges.

The next day, March 17, he gave another $3,500 talk about Paxil in Kissimmee, Fla. In the week after writing to the conflict-of-interest committee, Dr. Nemeroff gave three talks on Paxil, for $3,500 each, at various locations in New York, according to the senator.

On July 6, 2004, Dr. Nemeroff promised the university he would limit his consulting work to Glaxo to under $10,000 a year, according to Sen. Grassley. But a week later, in two days of work, he exceeded that limit, according to records provided by the senator. He said that on July 12, 2004, GSK paid Dr. Nemeroff $3,500 in fees and $505.40 in expenses for a talk he gave on Paxil in Las Vegas; and that he was paid $7,000 for two talks he gave for Glaxo the next day.

In an Aug. 4, 2004, letter to a university dean, Dr. Nemeroff said he had “taken the necessary steps to be in compliance with the recommendations” of the Emory conflicts panel, “namely my consulting fees from GSK will be less than $10,000 per year throughout the period of this NIH grant, its renewals and final collections of data.” He said Glaxo had been informed of the step and was supportive.

But according to Glaxo records, Dr. Nemeroff exceeded the $10,000 limit that month.

The Paxil talks for Glaxo continued until at least January 2006. It appears the university questioned Dr. Nemeroff’s Glaxo relationship later that year, in November. In response to that questioning, Sen. Grassely says Dr. Nemeroff wrote that any suggestion he had a financial relationship with Glaxo is “absolutely untrue.”