More trouble for Merck

Already embroiled in a scandal over fake scientific journals it funded to promote its products, pharma giant Merck & Co. is now the subject of a law suit alleging that it misled customers into charging too much for prescriptions of cholesterol pills.

Also named in the suit over medications Zetia and Vytorin was Schering-Plough Corp., which Merck bought in March.

The companies have known for years -- and failed to make public -- that Zetia doesn’t reduce fatty arterial plaques that can cause heart attacks and strokes, according to the complaint filed June 5 in Philadelphia federal court. The suit, brought by the Pennsylvania Employees Benefit Trust Fund, seeks to recoup more than $9 million spent on the two drugs since October 2002. 

“Merck and Schering-Plough entered into, and through various overt acts implemented, an agreement between themselves to illegally promote Vytorin and Zetia,” lawyers for the fund said in the complaint.

Sales of Zetia and Vytorin fell 12 percent last year to $4.5 billion after two studies showed the pills may work no better at unclogging arteries than does an older, cheaper medicine called simvastatin. Vytorin combines Zetia and Merck’s simvastatin, a statin-class drug the Whitehouse Station, New Jersey-based company markets as Zocor.

Merck and Schering-Plough developed Vytorin to help further the profitable life of Zocor, which lost its patent protection in June 2006, according to the complaint. Generic Zocor alone costs 3 cents a pill compared to about $3 a pill for Vytorin, the complaint said.

“We believe the companies acted responsibly and appropriately and we intend to defend this lawsuit vigorously,” Ron Rogers, a spokesman for Merck, said today in a phone interview.

Schering-Plough spokesman Lee Davies said that company hasn’t yet been served with a copy of the complaint but plans to defend itself.

“Vytorin and Zetia have been shown to reduce LDL- cholesterol based on numerous clinical studies, and they have been approved by the FDA for that indication,” Davies said in an e-mailed statement.

The companies allegedly “suppressed” the results of a January 2008 study called Enhance that showed the drugs worked no better at clearing arteries than the generic drug simvastatin, according to the complaint. The companies also used false and deceptive marketing techniques claiming Vytorin was more efficacious than and just as safe as the much cheaper generic, the complaint said.

Meanwhile, according to Forbes magazine, Merck is facing "new questions about the company's drug development prowess" after its hoped-for next big heart drug rolofylline came back with disappointing results from clinical trials.

Merck publishing scandal widens

Pharmaceuticals giant Merck & Co. is refusing to answer questions about a growing scandal involving its publication of fake scientific journals that were, in fact, little more than promotions for its products.

Originally thought to have published six such journals, it now turns out Merck bought and paid for nine journals -- with 13 more in the works.

News of the fake journals broke in April in The Scientist when it reported that Merck had paid Australian publisher Elsevier to print Australasian Journal of Bone and Joint Medicine (AJBJM), without revealing that the publication was created and paid for by Merck.

The "vast majority"of articles in AJBJM during its 2002 to 2005 publishing life were favourable articles about Merck drugs Fosamax and Vioxx -- two medications that have been linked to dangerous side effects.

Fosamax is an osteoporosis drug that has been linked to cancer.

LegalView reports on the recent Fosamax side effects, which have caused patients to not only consider new medications but to discuss the potential for a Fosamax class action lawsuit as well. In January, two medical journals, The New England Journal of Medicine and the Journal of the American Dental Association provided a one-two punch against the drug’s manufacturers, Merck and Co., reportedly linking the drug to such side effects as esophageal cancer and jaw bone die-off. Patients of the osteoporosis drug are advised to contact a medical professional to discuss the drug and its alleged dangers.

Vioxx, an anti-inflammatory, was pulled off the market after independent studies found a link to increased heart attack and strokes.

Merck, in what Summer Johnson calls "passing the buck" in the respected blog.bioethics.net, is refusing to answer questions about the publishing scandal, referring all questions to Elsevier -- which says it is reviewing its policies and admits the publications never should have been called journals.

Johnson is having none it:

Simply because Elsevier took the bait doesn't mean Merck is off the hook. Elsevier is rightfully taking the heat for agreeing to create entire divisions of publications that an Elsevier spokesperson admitted "should not have been called 'journals'." What an admission! What to call a publication such as these really is the question--perhaps they will fade into oblivion such that we will not have to give them a name. Not a chance. ...

If Elsevier really wants to put this scandal behind them, they must throw the doors open wide and disclose everything--including how much they were paid. Eventually the facts will come out. When they do--and I'm only guessing the figure is astronomical--Elsevier will look like they were hiding some very dirty laundry. Merck already is passing the buck and leave Elsevier holding the bag. Thus far it looks like they are succeeding. 

The nine fake journals are: The Australasian Journal of Bone and Joint Medicine, the Australasian Journal of Neurology, the Australasian Journal of Hospital Medicine, the Australasian Journal of General Practice, the Australasian Journal of Cardiology, the Australasian Journal of Cardiovascular Medicine, the Australasian Journal of Clinical Pharmacy, the Australasian Journal of Clinical Practice, and the Australasian Journal of Musculoskeletal Medicine. 

The 13 planned fakes are: The Australasian Journal of Pediatrics, the Australasian Journal of Obstetrics and Gynecology, the Australasian Journal of Dentistry, the Australasian Journal of Infectious Diseases, the Australasian Journal of Pain Management, the Australasian Journal of Respiratory Medicine, the Australasian Journal of Sexual Health, the Australasian Journal of Psychiatry, the Australasian Journal of Asthma, the Australasian Journal of Gastroenterology, the Australasian Journal of Hospital Pharmacy, the Australasian Journal of Depression, the Core Journals in Oncology. 

 

Glow in the dark monkeys

Dubbed a "biomedical supermodel" by the journal Nature, a genetically modified monkey that glows in ultraviolet light has been developed by a team of Japanese researchers.

But it isn't the "Victorian freak show" qualities of the research that has scientists so excited. It's the potential for the breakthrough to help with future medical research.

 That's because -- unlike past glow-in-the-dark primates -- these marmosets were able to pass their modification on to their offspring. That means scientists may be able to develop monkeys that have been genetically modified to have human conditions. This would make them ideal for medical research.

Scientists have genetically engineered many other species to be research tools. Mice in particular have been created with a wide assortment of characteristics and diseases that mimic human ailments.

But because mice are so genetically different from humans, scientists have long sought to breed primates to provide better disease "models." Although scientists have been able to genetically modify individual monkeys, they had never before succeeded in getting the new traits to pass down through generations - a crucial step for creating large enough numbers for research.

The monkeys were developed by Erika Sasaki and her team at the Central Institute for Experimental Animals in Kawasaki, Japan, by adding a jellyfish gene to marmoset embryos that made them glow green. Last month, a male was born using sperm from one monkey, and two more glowing marmosets have been born since. One was killed when its mother bit it. The scientists plan to create families of monkeys that develop neuro-degenerative diseases.

“This is potentially very exciting,” said Kieran Breen of the Parkinson’s Disease Society. “Because primates are much closer to humans than mice, we’ll have a new animal model to work with.”

Not everyone was so excited, however.

The research was condemned by animal rights proponents, who said it paves the way for the producing of colonies of primates conceived expressly to suffer a plethora of cruel illnesses and undergo potentially painful and dangerous medical experiments.

Because the work marks the first time a species so closely related to humans has been genetically altered in this way, some also worried the same techniques would be used on chimps or other primates even closer to humans or to try to endow people with desirable genetic traits.

The BBC spoke to leading animal right activists in Britain, who questioned the need for such work.

Jarrod Bailey, science consultant to the British Union for the Abolition of Vivisection (BUAV), says he is "disappointed" both ethically and scientifically with the results.

"This sort of research on animals as sentient as monkeys and apes does not have public support," he told BBC News.

Furthermore, he thinks the underlying science is flawed. Animal researchers, he said, "have failed in research to find treatments for Aids, for hepatitis, for malaria, for strokes. Many treatments for strokes work in monkeys but don't work in humans."

"Monkeys do not predict human response and do not tell us about human disease," he added.

 

Altruistic vaccines

I wrote an article in today's Toronto Star about a novel way to fight Dengue Fever -- or potentially any other disease passed on by mosquitoes.

The idea is an "altruistic vaccine" that does nothing to help the person actually getting the shot. Instead, the person's blood is rendered poisonous to any mosquitoes who bite the vaccinated person -- making the little critters unable to spread the disease.

The vaccine is being developed at Queensland University, in a part of Australia with a fast-growing Dengue problem. Global warming is being blamed for its rapid spread. The Bill and Melinda Gate Foundation is funding the work.

All vaccines have some altruist qualities to them, ethicist Angus Dawson told me, in that governments fund vaccination programs to prevent the spread of disease. Altruistic drugs take that one step further by giving no direct benefit to the person getting the shot.

That much is in the story.

What I couldn't fit in was Dawson's observation that the research is an example of society continuing to look for technological solutions to problems with wider causes.

It would perhaps be more ethical, says Dawson, founding director of the Centre for Professional Ethics at Keele University in Britain and now a visiting ethicist at the University of Toronto's Joint Centre for Bioethics, to address the long-term, underlying causes of disease spreading in general -- such as poverty, lack of access to proper care and global warming.

 He's right, of course, but I won't hold my breath.

Flu ethics articles available free

Articles and editorials published in the American Journal of Bioethics over the past few years on pandemics and how to handle them are now available for free to help health officials figure out what to do about swine flu.

Presumably, for in the general public, the articles will also provide something to measure the actions of health officials and politicians against.

Here's a list of available articles:

Ethics, Pandemics, and the Duty to Treat by Heidi Malm, Leslie P. Francis, Robert Hood, Thomas May, Saad B. Omer, Daniel Salmon 2008; 8(8):4

OPCs: Carrots and Sticks: Keeping Healthcare Workers on the Job in a Public Health Disaster by Tia Powell 2008; 8(8):20

Health Care Workers' Willingness to Work in a Pandemic by Dorothy E. Vawter, J. Eline Garrett, Karen G. Gervais, Angela W. Prehn 2008; 8(8):21

Suppose They Gave an Epidemic and Nobody Came? by Neil Schluger 2008; 8(8):23

Not in My Job Description by Joanne Godley 2008; 8(8):25

Specifying the Duty to Treat by Michael J. Selgelid, Yen-Chang Chen 2008; 8(8):26

Ethics and Epidemics by Daniel K. Sokol 2008; 8(8):28

A Duty to Treat During a Pandemic? The Time for Talk is Now by Tracey M. Bailey, Thomas J. Marrie, Rhonda J. Rosychuk, Olive Yonge 2008; 8(8):29

The Duty to Care in a Pandemic by Joint Centre for Bioethics Pandemic Ethics Working Group 2008; 8(8):31

Without Consent: Moral Imperatives, Special Abilities, and the Duty to Treat by Nadia Sawicki 2008; 8(8):33

Public Health and Duties to the Population during a Pandemic by Kenneth Kirkwood 2008; 8(8):35

Remembering the "Pan" in "Pandemic": Considering the Impact of Global Resource Disparity on a Duty to Treat by Alison Reiheld 2008; 8(8):37

Healthcare Professionals and the Reciprocal Duty to Treat During a Pandemic Disaster by Darren P. Mareiniss 2008; 8(8):39

Pandemic Influenza and the Duty to Treat: The Importance of Solidarity and Loyalty by Mitchell A. Klopfenstein 2008; 8(8):41 EDITORIAL: A 1918 Flu Memoir by Ricki Lewis 2008; 8(8):3

EDITORIAL: Don't Be Chicken: Bioethics and Avian Flu by Laurie Zoloth, Stephen Zoloth 2006; 6(1):5

EDITORIAL: Risk and Trust in Public Health: A Cautionary Tale by Matthew K. Wynia 2006; 6(2):3

EDITORIAL: Markets and Public Health: Pushing and Pulling Vaccines into Production by Matthew K. Wynia 2006; 6(3):3

EDITORIAL: Strange Bedfellows? Reflections on Bioethics' Role in Disaster Response Planning by Jessica W. Berg, Nicholas King 2006; 6(5):3

EDITORIAL: Ethics and Public Health Emergencies: Rationing Vaccines by Matthew K. Wynia 2006; 6(6):4

EDITORIAL: Ethics and Public Health Emergencies: Restrictions on Liberty by Matthew K. Wynia 2007; 7(2):1

EDITORIAL: What Vaccination Programs Mean for Research by Jeffrey P. Kahn 2007; 7(3):3

EDITORIAL: Ethics and Public Health Emergencies: Encouraging Responsibility by Matthew K. Wynia 2007; 7(4):1

EDITORIAL: Mandating Vaccination: What Counts as a "Mandate" in Public Health and When Should They Be Used? by Matthew K. Wynia 2007; 7(12):2

Such articles would normally cost about $37 (Canadian). No word on how long they will be available.

Being a middle aged guinea pig

For anyone who has ever been tempted to participate in a health study -- or wondered about those who do take part -- it might be worth reading the Booster Shots medical blog at the LA Times.

The blogger, Rosie Mestel, takes readers through her experience being interviewed as a control subject for a cancer study.

A few weeks back, I came home to find a letter stuffed in my mailbox explaining that a group of researchers was seeking an adult woman to match against another individual in the neighborhood who'd had a cancer diagnosis. As far as I could figure, it was an epidemiology study in which they make lots and lots of similar matches and try to tease out lifestyle and other factors that may have a bearing on cancer risk.

I ummed and awwed for about a week, and then finally sent a form back with an agreement to be interviewed.

It turns out, she kind of liked it, and was sad to see it end.

From the other side of the gurney, researcher and blogger Summer Johnson, said the blog made her reflect on the impact her work has on her subjects.

Perhaps atypical, idiosyncratic, or just one person's point of view, it made me pause to think about the human subjects I've interviewed and how this process effects them during and after the research study is over.

Rights complaint against hospital

The parents of a baby girl who died at Toronto's Hospital for Sick Children have filed a complaint with the Ontario Human Rights Commission, saying their daughter received inadequate care and that a do not resuscitate order was filed without their consent.

The Star's Emily Mathieu writes about the case in today's Toronto Star.

The parents of Annie Farlow – a 2-month-old who died at the Hospital for Sick Children in 2005 after receiving what her parents allege was inadequate care because of a genetic condition – are attempting to take their case to the Human Rights Tribunal of Ontario.

"I think every child regardless of their disabilities deserves a chance at life and if the treatment or surgery is not in their best interest, then they deserve a dignified, comfortable and peaceful death," said Annie's mother, Barb Farlow, yesterday outside a meeting to determine if their application for a hearing will go forward.

Annie had Trisomy 13, a genetic condition associated with severe developmental and physical disabilities. The Farlows raised concerns that the hospital has a policy to provide children with genetic conditions only supportive care, keeping them comfortable until they die rather than attempt extraordinary life-saving measures.

The Farlows also said the hospital has been reluctant to release crucial records related to Annie's care – including an audit detailing the period of time close to her death.

The hospital said allegations that any child with a genetic condition or disability receives lesser care are untrue.

The rest of the story is here.

The Star's Helen Henderson also wrote about Annie last summer.

Annie's mother, Barbara, told her daughter's story at the University of Toronto's Joint Centre for Bioethics last June. Her lecture is archived here. The Farlows have also set up a web site to tell Annie's story.

The ethics of death

Partly as a follow up to the saga of Kaylee Wallace at Toronto's Sick Kids Hospital and partly because I have been thinking about the issue for a while, I wrote a couple of stories published in the Toronto Star today looking at death, how we handle it and how we define it.

Dead is dead, except when it's not.

"Death used to be a little more self-evident," says Kerry Bowman, a medical ethicist specializing in end of life issues at the University of Toronto's Joint Centre for Bioethics.

"Today, you're dead when the doctor says you are."

Deciding when somebody is dead or about to die is quickly emerging as one of the top ethical issues in medicine today as technology makes it increasingly possible to keep people alive who would otherwise have died not so long ago.

"The technology has far outstripped the ethics," says Tim Falconer, author of That Good Night: Ethicists, Euthanasia and End-of-Life Care. "Feeding tubes and ventilators weren't designed to keep people alive for 15 years, but that's what they're being used for."

As well, says Bowman, with organ transplants more common, deciding the precise moment of death has become vital, since under the "dead donor rule" organs can only be harvested once the donor has died. And the sooner after death that happens, the healthier the organs will be.

Fro the rest of the story, click here.

In a companion piece, I also take a closer look at Falconer's book, which I blogged about last week.

Tim Falconer didn't set out to write a book about death. It just worked out that way.

He planned to write about ethicists and the growing role they seem to be playing in our modern lives – from business to government to medicine – and explain how they do their jobs.

But like any journalist, he was attracted like a bug to light to the most intriguing stories. Those were the ones about death and end-of-life ethical issues.

In That Good Night: Ethicists, Euthanasia and End-of-Life Care, which takes its name from the Dylan Thomas poem Do Not Go Gentle Into That Good Night, Falconer takes the reader on his journey through the increasingly ethically complicated ways death is handled in modern society – particularly in hospitals.

Few of us, he says, are prepared.

"We go through life knowing we are going to die, and then it's a surprise when it happens," says Falconer, a magazine writer and journalism professor at Ryerson University.

With all the machines that can keep us alive today, the medications and the medical advances, death, Falconer says, is increasingly more of a "negotiated event" than a sudden thing.

For the rest of the story, click here.

 

Book guides us into That Good Night

Here's something I didn't know until I read the latest book by Toronto-based magazine writer and Ryerson University instructor Tim Falconer, That Good Night: Ethicists, Euthanasia and End of Life Care:

The word Euthanasia comes from the Greek for "Good Death."

Leaving aside the question of whether I should have known the origins of the word euthanasia (today's schools aren't big on ancient Greek), it says a lot, I think, about how modern society has come to view death since this word was first coined.

In our society, post-eugenics and post Nazi-ism, the word euthanasia has much darker connotations than a literal translation would suggest. Today, it conjures up images of cruelty, designer babies and a world in which some people are ranked ahead of others (and other ranked as lesser beings).

With all that baggage, it is hardly surprising that so many people -- particularly from the disabled community -- have been so vocal in their opposition to anything that might make euthanasia possible in Canada. In North America, only Oregon and Washington state have euthanasia laws, with Pennsylvania currently considering legislation.

Falconer would like to see euthanasia and assisted suicide laws in Canada, with strict controls. He's not optimistic it will happen any time soon, however. A full story will appear int eh Toronto Star soon.

GlaxoSmithKlein plan for developing countries backfires

A recent announcement by drug giant GlaxoSmithKlein to spend 20 per cent of its profits from developing country sales on building the health care infrastructure of those same countries, and to sell patented drugs there at a quarter of their market price, sounded quite generous.

At least on the surface.

The plan, however, has not held up to the scrutiny of some of those analyzing it, including The Global Bioethics Blog, which focuses on biotech research in developing countries.

These promises may make GSK look saintly, but the impression largely fades on reflection. 20% of GSK's profits in developing countries does not amount to much. ...

Gestures of philanthropy towards the world's poorer nations, on the part of aggressively profit- seeking pharmaceutical companies, is to be taken with a grain of salt at the best of times. In a down economy, when pharmaceutical companies are merging for their own survival, full-blown skepticism is in order.

The blog cites an editorial in the respected medical journal, The Lancet, and an analysis of the Glaxo plan by the Policy Innovations think tank -- which both point out that because the company makes so little money in poor developing countries (where few can afford its products), 20 per cent of its developing country profits is very little indeed.

... an editorial in the Lancet calculates it as less than 0.1% of GSK's total profits, and the folks at Policy Innovations see this as boiling down to about $50,000 per country, hardly a generous investment in local health infrastructure. Selling patented medicines at a quarter of the usual (bloated) price may not be of much help either to those who live on a few dollars per day. And while giving access to patents sounds nice, the road from possession of patent information to research to marketing is a long and winding road paved by a great deal of money. Who has that kind of money? The big pharmaceutical companies, like GSK. But they won't really invest to create drugs for conditions affecting developing countries because the profit margin would be meagre. We come full circle.

Not everyone, of course, questioning the company's move. New Scientist welcomed it, noting that it at least will spark a debate about how much Big Pharma should do to help people in developing countries.

Oxfam spokesman Rohit Malpani urged other companies to emulate GSK, but would like to see the company free up its anti-HIV medication patents as well. Richard Barker of the Association of the British Pharmaceutical Industry says GSK's stance will spark a debate about "how much further industry can and should go" in promoting global health.