Dr Chuck Nemeroff, CeNeRx and his amazing, missing disclosure…

CL Pysch has a great story:

Seems Chuck is a consultant for 18 drug companies and a speaker for four. His list of disclosures from a recent piece of CME (continuing medical education) in the USA reads like this:

AstraZeneca Pharmaceuticals, LP, Bristol-Myers Squibb Company, Forest Laboratories, Janssen Pharmaceutica, National Institute for Mental Health, Pfizer Inc, Wyeth-Ayerst Laboratories, Consultant: Abbott Laboratories, Acadia Pharmaceuticals, Bristol-Myers Squibb Company, Concept Pharmaceuticals, Ltd, Cypress Bioscience, Inc, Cyberonics, Inc, Eli Lilly and Company, Entrepreneur Fund Inc, Forest Laboratories, GlaxoSmithKline, H. Lundbeck A/S, Ingenix i3 DLN, Janssen Pharmaceutica, Otsuka America Pharmaceutical, Inc, Pfizer Inc, Quintiles Transnational Corporation, UCB Pharma, Wyeth-Ayerst Laboratories; Speaker: Abbott Laboratories, GlaxoSmithKline, Janssen Pharmaceutica, Pfizer Inc.; Stockholder—Acadia Pharmaceuticals; Corcept Therapeutics, Inc; Cypress Biosciences; NovaDel Pharma Inc.; Board of Directors: American Psychiatric Institute for Research and Education, NovaDel Pharma Inc, National Foundation for Mental Health.

The CME piece in question was comparing MAOIs with SSRIs and Chuck wrote “Certainly other data and my own experience would suggest that MAOIs are superior to SSRIs and TCAs [for atypical depression]”.

He also wrote “A new transdermal system is currently available that enables the MAOI to avoid first-pass metabolism by bypassing the gut, thereby reducing the chance of hypertensive reactions caused by tyramine.”

And the Missing Disclosure?

Remember how the above CME was all about pushing a newer, safer MAOI drug for depression? Well, it just so happens that Nemeroff is the co-chair of the Scientific Advisory Board for CeNeRx, a company that is developing a (you guessed it) newer, safer MAOI drug for depression! Note that Nemeroff did not mention his position with CeNeRx in his disclosure for the Medscape CME activity. And here’s what the CEO of CeNeRx had to say about the MAOI they are testing:

“In contrast to other MAO inhibitors, our third generation RIMA series is designed to bind selectively and reversibly, with the goal of significantly reducing the cardiovascular risks and other side effects typically associated with the MAOI class. These safety results, along with the high plasma levels and favorable pharmacokinetics demonstrated in the study, support advancing Tyrima into a multiple dose safety study in late spring.”

So let me get this right. Chuck talks up a new third generation MAOI in a CME activity, yet does not disclose that he is being paid by the company which also manufactures that third generation MAOI

Nice work Chuck.

Read the whole sordid story over at CL Pysch’s blog – now!…

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Harrington Investments Divests From GlaxoSmithKline

August 29, 2007

Contact: Jack Ucciferri

(707) 257-7923 Fax

(707) 252-6166 Voice

www.harringtoninvestments.com

Harrington Investments Divests From GlaxoSmithKline

Cites Litany of Concerns

Napa, CA – Harrington Investments, Inc. (HII), a socially responsible investment (SRI) advisory firm, announced today that it has divested from GlaxoSmithKline (GSK) stock.

“In accordance with our long term investment management style, we would prefer to remain invested in GSK,” said John Harrington, President and CEO of Harrington Investments. “However, we have a fiduciary duty to our clients that includes a comprehensive review of a corporation’s overall operations and reputation.”

In a letter to GlaxoSmithKline CEO, Jean-Pierre Garnier, Harrington listed six points of concern with the company, including investigations for shady business dealings with Saddam Hussein, improper marketing of anti-depressants, and tax avoidance.

The letter also cited GSK’s inability to address the concerns of animal rights activists and its resistance to providing affordable AIDS drugs to developing countries.

The list concludes: “On a lighter note, we are bemused that GSK – one of the largest drug makers in the world – was recently ‘busted’ by two 14-year-old schoolgirls for wildly exaggerating the quantity of vitamin C present in a popular children’s fruit drink! Unfortunately, however, this action on the part of GSK continues to undermine your company’s reputation and your management’s credibility.”

Like many SRI firms, HII proactively avoids, or ‘screens out,’ stocks of corporations with significant negative environmental, social, and/or corporate governance (ESG) issues. Once it decides to purchase shares in a company, HII generally tries to work with corporate management to improve ESG performance.

HII’s divestiture of GSK stock is a reaction to corporate management’s consistent failure to address important investor fiduciary concerns.

#######

Jack Ucciferri
Research and Advocacy Director (RAD)
Harrington Investments, Inc.

ph. 707.252.6166
fax 707.257.7923

jack@harringtoninvestments.com

Challenges Persist for JP Garnier at Glaxo

A string of high-profile setbacks isn’t what Jean-Pierre Garnier envisioned as he enters the home stretch as CEO of GlaxoSmithKline, writes Robert Steyer at TheStreet.com

Back in 2006, he agreed to delay his retirement until May 2008, instead of October 2007, so he could shepherd the launch of new drugs with alluring revenue prospects. Instead, Garnier is spending much of his time defending the diabetes drug Avandia, coping with regulatory and scientific delays for two touted compounds and supervising a giant stock repurchase due to Glaxo’s slumbering shares.

“Diversity is Glaxo’s biggest strength,” says Heather Brilliant of the independent research firm Morningstar. “Clearly, Avandia will be an overhang for awhile. But Glaxo can withstand the bumps that affect other companies.” However, others say the new and experimental drugs won’t offset revenue surrendered from products that have lost patent protection or will lose exclusivity in the next few years. If Glaxo is too big to fail, it’s also too big to grow significantly without developing more mega-medications.

Glaxo suffers from “deteriorating earnings power,” says Alexandra Hauber, of Bear Stearns, in a recent report illustrating the bear case for Glaxo. Her underperform rating is based partly on the belief that “the combined sales potential of [R&D] pipeline assets looks insufficient to sustain GlaxoSmithKline’s earnings into the next decade.”

Hauber’s assessment came before an FDA advisory panel in late July recommended more restrictions for Avandia because they say it raises heart-attack risks. Afterwards she said Avandia’s prescription volume was “unlikely” to recover. Hauber’s firm has had a noninvestment banking relationship.

For the 12 months ended Aug. 15, Glaxo’s stock was down 10.4% while the Amex Pharmaceutical Index of mostly giant drugmakers was down 4.2%. Glaxo tried to prop up the stock last month with a big stock buyback, saying it will expand an original repurchase plan from $8.8 billion to $24.6 billion over the next two years. That may have temporarily mollified equity investors, but Moody’s Investors Service dropped Glaxo two notches from the Aa2 high-grade level to A1 upper-medium-grade.

Avandia remains Glaxo’s biggest headache as well as its second-biggest seller. Some medical research says Avandia raises the risk of heart attacks compared to other diabetes pills, a claim that Glaxo disputes. A recent recommendation by advisers to the FDA portends more restrictions and lower sales for the drug whose U.S. sales fell 31% in the second quarter and whose worldwide sales dropped 22%.

The FDA doesn’t always agree with its advisors, but it usually does so. The advisors voted 22-1 to keep Avandia on the market, but they also agreed by a 20-3 vote that Avandia has a higher risk of heart attack than other pills that control blood sugar.

Last week, the FDA said Avandia’s label will include the agency’s strongest alert for the risk of heart failure — the impaired pumping ability of the heart. Avandia’s label has carried a less urgent warning about heart failure, and the FDA is still reviewing the research on heart-attack risk.

Speaking of headaches, Glaxo and its partner Pozen (POZN – Cramer’s Take – Stockpickr) were recently hit with another delay for their migraine treatment Trexima. The FDA granted conditional approval in early August, but one condition is more testing, which could take several months. The original application was filed two years ago, and the FDA issued its first conditional approval in June 2006. “We think the drug has a decent chance of being approved,” says a recent note by the independent research publication BioMedTracker, which analyzes drug and biotechnology prospects.

Trexima represents a standard Big Pharma generic-competition defense — developing a close relative of a brand-name drug. Trexima combines the generic pain reliever naproxen with Glaxo’s patented Imitrex.
For the first half of 2007, Imitrex produced $656 million. U.S. sales rose 11%, but sales in Europe and other foreign markets were down. U.S. generic competition will start in February 2009. Glaxo wants to secure early FDA approval so it has more time to persuade doctors and patients that newer is better.

Trexima isn’t the only problematic partnered product. Another is Entereg, developed by Adolor, for treating constipation and bowel disorders in patients who take powerful drugs for chronic, noncancer pain.

Entereg has suffered a host of delays. In April, Glaxo and Adolor said unusual results in a late-stage clinical trial caused them to suspend several other studies. Patients taking Entereg had a higher-than-expected rate of cardiovascular problems, as well as benign and malignant tumors. The companies are reviewing the research, and they are preparing a response to the FDA’s questions about another use for Entereg.

In November, the FDA granted conditional approval to the product for treating post-operative ileus, or constipation and abdominal pain caused by high-strength painkillers taken by people recovering from surgery. The FDA wants more data about possible cardiovascular side effects, and the companies plan to file their response before Sept. 30.

November’s delay wasn’t the first for Entereg. The companies received conditional clearance in July 2005 with the agency asking for more efficacy data. Clinical trial results have played havoc with Adolor’s stock over the years.
And even when a partnered product reaches the market, the path to higher revenue isn’t always smooth.

Coreg CR, a controlled-release version of the blood-pressure/heart failure drug Coreg, is off to a weak start following a first-quarter launch. Coreg CR had $20 million in sales in the second quarter vs. Coreg’s $400 million.
Flamel Technologies (FLML – Cramer’s Take – Stockpickr)developed Coreg CR, but Morningstar and other observers say the drug has been slow out of the gate primarily due to Glaxo’s sales force spending so much time defending Avandia.

Lisa Blakemore-Brown, The British Psychological Society, Dr Rita Pal and the GMC – 2

Still more on this sorry tale of the GMC and the way it does business.

My first post on the story can be found here.

Now, I’d suggest you all go here to read the latest from Dr Aubrey Blumsohn at Scientific Misconduct.

The GMC (like the MHRA) has remained silent about the most serious and damaging integrity failures in medicine. This includes several cases of misrepresentation of commercially motivated pharmaceutical research (by doctors) which has led to untold suffering by patients. To facilitate the integrity lapses, all the GMC had to do was to do nothing – and they have done nothing with unparalleled skill.

Posted in GMC. 3 Comments »

Drug companies manipulate legal system to deny justice to patients

New York Times 21 August 2007

Merck’s Vioxx Defence Strategy Prevents Plaintiffs From Getting Compensation: The case of Vioxx litigations demonstrates that consumers of inadequately tested FDA-approved medicines that prove lethal, are no better off than in the pre-FDA snake-oil era.

The New York Times reports that despite Merck’s withdrawal of Vioxx from the market due to its causing cardiovascular damage, Merck’s legal defense strategy is working: The strategy’s successes, from the view of Merck and its shareholders, are clear:

“In fact, none of the 45,000 people who have sued Merck, contending that they or their loved ones suffered heart attacks or strokes after taking Vioxx, have received payments from the company. The lawsuits continue, for now in a state of legal limbo, with little prospect of resolution. In combating the litigation, Merck has made an aggressive, and so far successful, bet that forcing plaintiffs to trial will reduce the number of Vioxx lawsuits and, ultimately, its liability. Promising to contest every case, Merck has spent more than $1 billion over the last three years in legal fees. It has refused, at least publicly, to consider even the possibility of an overall settlement to resolve all the lawsuits at once.”

Plaintiff’s lawyers accuse Merck of manipulating the legal system “to deprive justice to tens of thousands of people whose cases can never be heard.”

Glaxo and all the the other drug companies take exactly the same action – they’re not interested in protecting patients, all they’re interested in is their profits.

If drug companies ever do have to make payouts, then they will make the payout conditional upon signing a gagging order – to keep the truth hidden – they buy our silence.

JP Garnier and his New Flu Vaccine plans: Just Another ‘Stupid Investment?’

You’ve got to wonder about JP and his stewardship of Glaxo. Just when he must have been happy to tie up some bird flu vaccine deals, we learn things may not be so straightforward. This from Ed Silverman at Pharmalot:

Have Glaxo and Novartis stumbled yet again? That’s the question raised in a look at Protein Sciences, a much smaller company using a DNA technology to develop flu vaccines that may prove faster than the methods being used by its much bigger rivals, Bloomberg News reports.

Losing the flu-shot race may be the latest in a series of setbacks for both drugmakers, which are building plants that are part of a $1 billion US initiative to produce millions of inoculations within six months of an outbreak of a deadly flu. But Protein Sciences, with just 40 employees, is close to winning approval for a method that would cut the time at least in half.

Novartis is investing $600 million to build a cell-based flu-shot plant in North Carolina, and has won a $221 million US government grant for clinical trials. And Glaxo, which is getting $275 million in US funding, is building a Pennsvlvania factory in a facility acquired from Wyeth for an undisclosed sum. Both are growing influenza virus in animal cells as an advance over the decades-old technique of making flu shots using chicken eggs.

But cell culture “is an amazingly stupid investment to make for the future,” argues Manon Cox, Protein Sciences’ chief operating officers. “It’s as if we’re still living 100 years ago and recombinant DNA was never developed.”

Apotex and Toronto University

This story just seen on the Scientific Misconduct blog – a must read!

Here’s the situation:

You are Robert Prichard, the President of a University. The University of Toronto to be specific. There is chaos all around you caused by the attempt by Dr Olivieri to publish what she has found in a drug trial involving a big commercial company. Apotex to be specific. One academic, Gideon Koren is sending anonymous threatening correspondence to several other academics. You are caught in the middle of all of this.

You receive a letter. You suddenly realise who it is from. It’s Dr Bernard C Sherman PhD P. Eng (CEO of Apotex Inc)!

It begins: “As you know, Apotex has committed to donate to the University of Toronto $20 million for the new Medical Sciences Building, and Is close to finalizing an agreement to increase the donation to $55 million, which would also encompass a new building for the Faculty of Pharmacy and other projects. I am writing to advise you that Apotex is now confronted with an Impending force majeure, which, if not averted, will likely compel cancellation of our entire commitment to the University.”

Read on here – you won’t believe it.

I’m not sure what you would call the Apotex letter – maybe a suggestion – maybe a request – maybe lobbying – maybe blackmail – maybe a threat – maybe a command?

I just can’t make make up my mind – I’ll leave that to you…

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