OK then – what we need is for someone to write a Wikipedia article specifically about the rise of UK blogs that are written by patients who have been injured by taking Seroxat or SSRIs.
How’s that?
It could reference this blog, Seroxat Sufferers, Truthman30′s blog, Matthew Holford’s new blog…. the list could go on.
Anyone out there want to take it on?
I’m aware that many people visit this blog following links from various Wikipedia articles. How much longer this will go on I have no idea as I’ve been alerted by a reader to the fact that some edits have been made that remove all mention of Seroxat Secrets and various other websites…
“Mewstarget.com [sic] website, seroxat secrets website, Paxil protest website, Hugh James solicitors website are not acceptable sources according to the Wikipedia guidelines, and I am deleting them.”
So wrote someone called Paul Gene.
And he has deleted entries like this:
The lawsuit stemmed from a [[Consumer protection|consumer advocate]] protest against Paroxetine manufacturer GSK. Since the FDA approved paroxetine in 1992, approximately 5,000 U.S. citizens – and thousands more worldwide – have sued GSK. Most of these people feel they were not sufficiently warned in advance of the drug’s side effects and addictive properties.
According to the Paxil Protest website, hundreds more lawsuits have been filed against GSK. Newstarget September 06, 2005 The Paxil Protest website was launched August 8, 2005 to offer both information about the protest and information on Paxil previously unavailable to the public. Just three weeks after its launch, the site received more than a quarter of a million hits.
The original Paxil Protest website is no longer available. It is understood that the action to remove the site from the internet was undertaken as part of a confidentiality agreement or ‘gagging order’ which the owner of the site entered into as part of a settlement of his action against GlaxoSmithKline. (However, in March 2007, the website Seroxat Secrets discovered that an archive of Paxil Protest site was still available on the internet via Archive.org) Gagging orders are common in such cases and can extend to documents that defendants wish to remain hidden from the public. However in some cases, such documents can become public at a later date, such as those made public by Peter Breggin in February of 2006. A press release from Dr. Breggin can be seen here:
In January 2007, according to the Seroxat Secrets website, the national group litigation in the United Kingdom, on behalf of several hundred people who allege withdrawal reactions through their use of the drug Seroxat, against GlaxoSmithKline plc, moved a step closer to the High Court in London, with the confirmation that Public Funding had been reinstated following a decision by the Public Interest Appeal Panel. The issue at the heart of this particular action claims Seroxat is a defective drug in that it has a propensity to cause a withdrawal reaction. Hugh James Solicitors confirm this news on their website.
Paul Gene also deleted this entry about Robbie Willams – saying that the article cited in the Sun did not mention Seroxat:
On the 12th Of February 2007 singer Robbie Williams checked himself into rehab to kick his addiction to Seroxat.
The article is here – please visit it and you’ll see part of the article reads “The singer finds it impossible to get to sleep until 4 or 5am due to insomnia and is on sleeping pills. He is hooked on the powerful and controversial anti-depressant Seroxat, which has been linked to suicidal tendencies in teenagers.”
So then, I wonder what Paul Gene’s motivation is… I wonder who he works for?
No, this isn’t a joke, rather a new spin on the serotonin fairy tale (that presupposes that ANYONE can me exactly how an SSRI like Seroxat works – and by the way, Glaxo doesn’t know):
A type of drug has been found that starts working much faster against depression than current medications. Behavioural and molecular tests in rats show that the compounds kick into action in days, rather than weeks.
But the drugs — called serotonin receptor agonists — won’t be replacing Paxil (paroxetine) soon. None has yet been approved for treating depression in humans, and some have been scrapped because of concerns over side effects.
But researchers are still keen to pursue them, because the most popular type of antidepressant, called selective serotonin reuptake inhibitors (SSRI), can take up to two months to start easing symptoms. And for one-third of people with depression, they don’t work at all.
“This is a very good first step in identifying and potentially having a rapidly acting antidepressant,” says Ronald Duman, a drug expert at Yale University in New Haven, Connecticut. “But there’s a lot of work to done.”
Serotonin sponges
SSRIs such as Prozac have become a household name over the past three decades, garnering many millions of prescriptions every year in adults, children and even pets. The drugs work by stopping neurons from greedily keeping hold of a neurotransmitter called serotonin, so allowing more of the pleasure-providing molecule to reach protein receptors in nearby brain cells.
But in most patients, the drugs take weeks to work, says Guillaume Lucas, who did the work as a graduate student at McGill University in Montreal, Canada. “In major depression you have a real risk of suicide,” he says.
This lag is caused by specialized proteins called autoreceptors, which sop up the extra serotonin. After several weeks these receptors get used to the extra serotonin and release the molecule, allowing it to spread to where it is needed to lift mood.
Super recognition
Lucas and his supervisor Guy Debonnel, who died last year, reasoned that serotonin’s action could be increased by activating the proteins that recognize it, rather than by boosting the amount circulating between neurons. This could circumvent the early counteraction of autoreceptors, and speed up the effect.
The team found two compounds that did the job — one from a chemical supply company and the other from an abandoned clinical trial for irritable bowel syndrome.
In one test, rats were exposed to stress such as water deprivation, flashing lights and crowding for several weeks, while some received an antidepressant. The researchers then tested them for sugar consumption. Depressed rats, the researchers knew from previous studies, are less likely to partake in sweet treats. The rodents that received an antidepressant were less sugar-shy than controls, and the ones that got the new serotonin receptor agonists regained their sweet tooth a week earlier than those given an SSRI.
Two other behavioural tests in rats showed that the drugs were fast-acting, as did several molecular studies. After three days, rats receiving serotonin receptor agonists showed signs of new neuron growth — another indicator of antidepressant action — whereas the SSRI-treated rats did not. The results are reported in Neuron1.
Challenges ahead
Although the studies were done in rats, the researchers suggest that serotonin receptor agonists might also be speedier than SSRIs in humans. “We can expect therapeutic benefits to appear four to five times more rapidly,” says Lucas, who is now at the University of Montreal.
Lucas, who has patented the idea of melding serotonin receptor agonists with SSRI’s, hopes to see clinical trials start as soon as compounds are found that are safe in humans. Sanofi-Aventis, a pharmaceutical company based in Paris, is testing another serotonin receptor agonist as a treatment for dementia, he says.
The study stands out because it looked at several different ways of monitoring depression in rats and found the same answer, says Duman. But he cautions: “It really has to be taken with a grain of salt because these are rodent models, and they’re a long way from what could happen in human studies of depression.”
I’ll just run that by you again shall I… “Depressed rats, the researchers knew from previous studies, are less likely to partake in sweet treats. The rodents that received an antidepressant were less sugar-shy than controls, and the ones that got the new serotonin receptor agonists regained their sweet tooth a week earlier than those given an SSRI”. All sounds a bit thin to me. Post-rationalisation anyone?
And from this guesswork, Lucas is able to leap straight to “We can expect therapeutic benefits to appear four to five times more rapidly…”
I wonder if any drug companies are pouring funding into the University of Montreal…
The article is here.
“I’ll be a hero in three years” JP Garnier 5 April 2004
Sorry JP, but I think you’re past your sell by date.
This from today’s Observer:
GlaxoSmithKline, the UK drugs giant, faces a shareholder revolt over its dismal share price performance. Anger has spilt into discussions between investors and chairman Sir Christopher Gent over who should succeed chief executive Jean-Pierre Garnier. He is due to retire in May 2008.GSK’s big institutional shareholders have held meetings with Gent and told him in no uncertain terms that Garnier’s successor should be someone who is prepared to undertake a fundamental overhaul of the company and consider a radical streamlining of its operations, including a possible break-up.
One institutional investor says: ‘What we are telling the chairman is that with the industry facing a regulatory clampdown that makes it more difficult to get new medicines approved, GSK should look at ways to release shareholder value. The status quo is no longer an option.’
Another shareholder, who spoke on the basis of anonymity, says: ‘GSK should recognise that Big Pharma is broken and needs to be fixed. Garnier’s successor needs to take that on board. It’s no good producing more of the same.’
GSK’s shares traded at close to £15 in early 2000 against a Friday close of £12.79. The stock price has been hit by safety fears linked to Avandia, one of its leading drugs, worries about generic competition and concern about a possible dearth of new blockbuster medicines in GSK’s R&D pipeline.
Neil Ransome, head of the pharmaceuticals department at PricewaterhouseCoopers’ corporate finance arm, said recently: ‘Evidence that mega-mergers in this sector improve the rate of discovery of new drugs isn’t compelling.’
Analysts Citigroup shook the market earlier this year with research suggesting breaking up GSK could boost the value of the firm by half and enable the company to return £20bn to shareholders.
Read the entire article here at the Observer.
For more detail on Glaxo’s challenges, see here.
The list of the “great and the good” who regulary monitor Seroxat Secrets continues to grow – but it seems they only like to watch – why won’t you talk to me? Put that whistle in your mouth and blow as hard as you can.
Go on – talk to me – the email link is on the right hand side of the page.
Abbott Laboratories, North Chicago, Illinois
Abbott Laboratories, Gurnee, Illinois
Abbott Laboratories, Libertyville, Illinois
ACCENTURE, United Kingdom
A C NIELSEN, New York
ACGME, Chicago, Illinois
ACTIVX BIOSCIENCE, La Jolla, California
Adpepper.com
Allegiance Healthcare, Waukegan, Illinois
American Red Cross, National Headquarters, Washington
American Society of Clinical Oncology, Alexandria, Virginia
AMGEN, Potters Bar, United Kingdom
AMGEN, Thousand Oaks, California
Anapharm, Quebec, Canada
APCO Worldwide (DC HQ), Washington, District of Columbia
Apotex Inc., Ontario, Canada
Arnold and Porter Partnership, London
Ashurst Morris Crisp, Edmonton, United Kingdom
Astra AB, Södertälje, Sweden
Astra Zeneca, Lenni, Pennsylvania, United States
Astra Zeneca, Montchanin, Delaware
Astra Zeneca, Thornton, Pennsylvania
Avalanche Strategic Communications, Hackensack, New Jersey
Aventis Pasteur, Maidenhead, Windsor
Aventis Pharamceuticals, New Jersey
AXA Ireland
Bausch & Lomb, Rochester, New York
BALLARD, SPAHR, ANDREWS, Philadelphia, Pennsylvania
Bayer Corporation, Pittsburgh, Pennsylvania
BBDO NY, New York
Bear Stearns Security Corporation, New York
Biogen, West Roxbury, Massachusetts
Bircham Dyson Bell, London, London
BMG Avocats, Genève, Geneve
Bny Esi & Co., New York
Boehringer Ingelheim Limited, Egham, Slough
Boehringer Ingelheim Pharmaceuticals, Danbury, Connecticut
Boehringer Ingelheim Pharmaceuticals, Redding, Connecticut
Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut
Boehringer Ingelheim Pharmaceuticals, Copenhagen
Booz, Allen, and Hamilton, Sterling, Virginia
BKD LLP, Springfield, Missouri
Bradley, Arant, Rose and White, Birmingham, Alabama
Brigham Young University, Provo, Utah
Bristol Myers Squibb Pharmaceutical Research Institute, Europe
Bristol Myers Squibb Pharmaceutical Research Institute, Monmouth Junction, New Jersey
Bristol Myers Squibb Pharmaceutical Research Institute, Plainsboro, New Jersey
Brown University, Providence, Rhode Island
Burson – Marsteller BVBA, Brussels
Burson Marsteller, New York
Burson Marsteller (SEA) Pte Ltd, Singapore
CBS, New York
California State University, Northridge
Capital One Financial, Richmond, Virginia
Chamberlain Communications Group, New York
Carnegie Mellon University, Pittsburgh, Pennsylvania
Charles University, Prague, Czech Republic
Chemmedica, London
Church of Scientology International, Los Angeles, California
Clark Depew Tracey, Houston, Texas
Cleveland Clinic Foundation, Cleveland, Ohio
CMP MEDIA LLC, Great Neck, New York
Collective Intellect, Boulder, Colorado
Columbia-Presbyterian Medical Center, New York
Commission Europeenne, Wezembeek-Oppem, Brabant
Corbett Healthconnect, Chicago, Illinois
Cornerstone Partners, New York
Corp McCann Erickson, New York
Cypress Bioscience, San Diego, California
D’arcy Masius Bention & Bowles, New York,
Debevoise & Plimpton, New York
Dechert LLP, Philadelphia, Pennsylvania
Democratic National Headquarters, Washington, District of Columbia
DENDRITE INTERNATIONAL, Bernardsville, New Jersey
Department of Veterans Affairs, North Liberty, Iowa
DISTRIBUTION SOLUTIONS, Traverse City, Michigan,
DOIM, Laurel, Maryland
Edelman PR, Alexandria, Virginia
Edelman, London
Edelman PR, New York
Edelman PR, Seattle, Washington
E.I. du Pont de Nemours and Co., Wilmington, Delaware
Eisai Co., Ltd., Kashiwa, Japan
EXELIXIS, San Mateo, California
Eli Lilly and Company, Europe
Eli Lilly and Company, Indianapolis, Indiana
Eli Lilly and Company, Terrey Hills, New South Wales
Elron Technologies, Israel
Elsevier Science Limited, Bletchingdon, Oxfordshire
Emory University, Atlanta, Georgia
EURO RSCG MVBMS PARTNERS, New York
European Parliament, Brussels
Evergreen Medical Group, Kirkland, Washington
Experian Information Solutions, Roswell, Georgia
FDA, Parklawn Computer Center / DIMES HQ, Silver Spring, Maryland
Finkelstein, Thompson & Loughran, Washington, District of Columbia
Fisher & Paykel Ltd., Northmead, New South Wales
Foote, Cone & Belding , New York
Forest Labs, New Hyde Park, New York
GALDERMA LABS, Fort Worth, Texas
Genentech, Dixon, California
Genentech, San Francisco, California
General Medical Council, United Kingdom
General Motors Corporation, Bloomfield Hills, Michigan
Gerson Lehrman Group, Austin, Texas
Gilead Sciences, Boulder, Colorado
Glaxo., King Of Prussia, Pennsylvania
Glaxo, Raleigh, North Carolina
GlaxoSmithkline, Mississauga, Ontario
Glaxosmithkline S.p.A, Verona, Veneto
Government of the Province of Ontario, Scarborough Junction, Ontario
Greek Academic & Research Computer Network, Athens
Grey Advertising, Brooklyn, New York
GREY GLOBAL GROUP, Shooters Hill, Newham
Group Health Cooperative, Seattle, Washington
Haymarket Media, Garfield, New Jersey
Health and Welfare Agency Data Center, Clarksburg, California
Healy Communications, Chicago, Illinois
Hearst Corporation, New York
Hikma Pharmaceuticals, Amman, Jordan
ICON CLINICAL RESEARCH, United Kingdom
Illinois Criminal Justice Information Authority, Chicago
Imperial College of Science, Technology and Medicine, London
Institute for International Research, New York
Institute of Neurology, London University
Internal Revenue Service, Highland, Maryland
James, Houer, Newcome & Smiljanich, Birmingham, New Jersey
Jones, Day, Reavis & Pogue, Cleveland, Ohio
The Johns Hopkins Medical Institutions, Baltimore, Maryland
Josef Nopp KG, Leonding, Oberosterreich, Austria
Johnson & Johnson, Europe
Johnson & Johnson, Fort Wayne, Indiana
Johnson & Johnson, Fulmer, Slough
Johnson & Johnson, New Jersey
Johnson & Johnson, Sydney, New South Wales
JP Morgan Chase & Co, Columbus, Ohio
JP Morgan Chase & Co, New York
Kaiser Permanente, El Cerrito, California
Kaiser Permanente Medical Care Program, Los Angeles, California
Kendle, Glasgow, Scotland
Ketchum Communications, Pittsburgh, Pennsylvania
King & Spalding, Washington DC
Kirkland & Ellis LLP, Midlothian, Illinois
Kunitz and Associates, Rockville, Maryland
Lehman Brothers, London
Life Science Communications, Upper Holloway, Redbridge
LNS Communications, Brookline, Massachusetts
Loyola Marymount University, Los Angeles
M&C Saatchi, New York
Management Centre Europe, Brussels
Marina Maher Communications, New York
Mayo Foundation, Rochester, Minnesota,
McCarter & English, Newark, New Jersey
MCKINSEY AND COMPANY, Boston, Massachusetts
Marcus Evans, Chicago, Illinois
McCann-Erickson GuangMing Lt, Hong Kong
McCann-Erickson, London
McCann-Erickson, New York
McCann-Erickson/Torre Lazur, Denville, New Jersey
MDE INVESTORS, Washington, DC
Medical Broadcasting Company, Philadelphia, Pennsylvania
Medicom Group, Newbury, United Kingdom
Meditech Media, London
Medstat Systems, Ann Arbor, Michigan
Medtrials, Dallas, Texas
Medtrials, Pennsylvania, United States
Merck and Co., Montgomeryville, Pennsylvania
Merck and Co., Skillman, New Jersey
Meta Pharmaceutical Services LLC, Conshohocken, Pennsylvania
Medicines Australia Incorporated, Napier, Western Australia
Medtronic, Incorporated, Minneapolis, Minnesota
Michigan Medical PC, Grand Rapids, Michigan
Microsoft Corp, United States
MORI, London
Morgen Walke Associates, Brooklyn, New York
Mount Sinai School of Medicine, New York
Munro and Foster, London
NATIONAL HEALTHCARE GROUP, Singapore
National Institutes of Health, Bethesda, Maryland
National Institute for Medical Research, London
Neuronetics, Malvern, Philadelphia
Nelson Mullins Riley & Scarborough, Columbia, South Carolina
Network of Shire Pharmaceuticals, United Kingdom
News Corporation, New York
North Carolina State University, Raleigh, North Carolina
Northwestern University, Evanston, Illinois
Novartis AG, Europe
Novo Nordisk Pharmaceutical, Princeton, New Jersey
Norwegian University of Science and Technology, Trondheim
O’Melveny & Myers, Los Angeles, California
Ogilvy & Mather, Chicago, Illinois
Ogilvy and Mather Worldwide, New York
One to One Interactive, LLC., Boston, Massachusetts
Organon Pharmacy, Roseland, New Jersey
Otsuka America Pharmaceutical, Gaithersburg, Maryland
Parklawn Computer Center / DIMES HQ, Rockville, Maryland
PDI, Saddle River, New Jersey
Performance Systems International, Toronto, Ontario
Pepper, Hamilton and Sheetz, Philadelphia, Pennsylvania
Pfizer, Australia
Pfizer, New York
Pfizer, Quaker Hill, Connecticut
Pfizer, United Kingdom
PHILLIPS LYTLE LLP, Buffalo, New York
Porter Novelli, New York
PricewaterhouseCoopers GTS UK, London
Publicis & Hal Riney, El Cerrito, California
QORVIS COMMUNICATIONS, Washington, District of Columbia
Quintiles, Raleigh, North Carolina
Ragan Communications Inc, Chicago, Illinois
Regulatory Affairs Professionals Society, Rockville, Maryland
Research Triangle Institute, Durham, North Carolina
R G C Jenkins & Co, London
R I S Christie, Toronto, Ontario
Rosen & Livingston, Brooklyn, New York
Ruder Finn, London
Sankyo Pharma, Parsippany, New Jersey
Sanofi Synthelabo, Guildford, United Kingdom
Sanofi Synthelabo (S) PTE LTD, Singapore
Sanofi Techniques, Bourg-la-Reine
Schering-Plough Corporation, Plainfield, New Jersey
Scientific American, New York
Scottish Association for Mental Health, Glasgow
Semyung University, Chungbuk, Kyongsang-bukto, Korea
Servier Laboratories, Slough, United Kingdom
SHIRE US, Valley Forge, Pennsylvania
Shire US, Wayne, Pennsylvania
Shock Hardy & Bacon, Overland Park, Kansas
Sisters of Mercy Health System, Saint Louis, Missouri
Smith Hanley, Indianapolis, Indiana
SmithKline Beecham, Ickenham, Slough, United Kingdom
SmithKline Beecham, North Weald, Havering, United Kingdom
SmithKline Beecham Biologicals, Brussels
Spotts Fain PC, Richmond, Virginia
St. John Medical Center, Tulsa, Oklahoma
St Josephs Health System, Anaheim, California
State of CA, Dept. of Consumer Affairs (DCA), Sacramento, California
State of Maryland, Annapolis, Maryland
Steptoe & Johnson, London
Steptoe & Johnson, Washington, District of Columbia
Syntex USA, Livingston, New Jersey
Syntex USA, Switzerland
Syracuse Research Corporation, Syracuse, New York
Takeda Pharmaceuticals A, Chicago, Illinois,
Takeda Pharmaceuticals North America, Lincolnshire, Illinois
Takeda UK Ltd, High Wycombe, Buckinghamshire
Texas A&M University, Corpus Christi, Texas
The Bill & Melinda Gates Foundation, Newington, Virginia
The Connecticut Hospital and Affiliates, Monroe, Connecticut
The Gardiner-Caldwell Group Ltd, Macclesfield, United Kingdom
The McGinn Group, Fredericktown, Ohio
The Nielsen Company, New York
The Procter and Gamble Company, Cincinnati, Ohio
The United States Centers For Disease Control, Atlanta, Georgia
Trinity Mirror Group, London
TROUTMAN SANDERS, Atlanta
True North Communications, Chicago
TRW Space and Defense Sector, Torrance, California
Ulmer Berne, United States
Ulmer & Berne LLP, Cleveland, Ohio
UNDERWRITERS LABORATORIES, Mount Prospect, Illinois
Universiteit van Amsterdam, Amsterdam
University of California, Irvine, Irvine
University of Cape Town, Cape Town, South Africa
University of Manchester, Manchester, England
University of Newcastle upon Tyne, United Kingdom
University of New Hampshire, Durham, New Hampshire
University of Portsmouth, Portsmouth, United Kingdom
University of Toronto, Toronto, Ontario
University of Westminster, London
USA TODAY, McLean, Virginia
U.S. Dept. of Commerce – ITA, Cheltenham, Maryland
U.S. Dept. of Health and Human Services, Washington, District of Columbia
U.S. Department of State, Arlington, Virginia
U.S. Senate Sergeant at Arms, Arlington, Virginia
V-Fluence, Salem, Massachusetts
Video Monitoring Services of America, LP, Bronx, New York,
VJIL Consulting, Hyderabad, India
Waldner & Associates, Houston, Texas
Waggener Edstrom, Portland, Oregon
Walgreens, Arlington Heights, Illinois
Warner-Lambert Company, Morris Plains, New Jersey
WATSON PHARMACEUTICALS, Riverside, California
Westminster Group, Westminster, United Kingdom
WILEY, REIN & FIELDING, Washington, District of Columbia
WPP Group, New York
WPP GROUP U.S. INVESTMENTS, Miami, Florida
Wyeth-Ayerst Research, Horsham, Pennsylvania
Wyeth-Ayerst Research, Waldwick, New Jersey
Yale University, New Haven, Connecticut
Young & Rubicam-Media Edge, San Francisco, California
Youngstown State University, Youngstown, Ohio
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.
August 29, 2007
Contact: Jack Ucciferri
(707) 257-7923 Fax
(707) 252-6166 Voice
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
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.
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.
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.
