Fever to Harness RNA Interference Cools – NYTimes.com
by ilene - February 10th, 2011 12:45 pm
Drugmakers’ Fever for the Power of RNA Interference Has Cooled
By ANDREW POLLACK
When RNA interference first electrified biologists several years ago, pharmaceutical companies rushed to harness what looked like a swift and surefire way to develop new drugs.
Billions of dollars later, however, some of those same companies are now losing their enthusiasm for RNAi, as it is called. And that is raising doubts about how quickly, if at all, the Nobel Prize-winning technique for turning off specific genes will yield the promised bounty of innovative medicines.
The biggest bombshell was dropped in November, when the Swiss pharmaceutical giant Roche said it would end its efforts to develop drugs using RNAi, after it had invested half a billion dollars in the field over four years.
Just last week, as part of a broader research cutback, Pfizer decided to shut down its 100-person unit working on RNAi and related technologies. Abbott Laboratories has also quietly shelved its RNAi drug development work.
“In 2005 and 2006, there was a very sudden buildup of expectation that RNAi was going to cure many diseases in a very short time frame,” said Dr. Johannes Fruehauf, vice president for research at Aura Biosciences, a small company pursuing the field. “Some of the hype, I believe, is going away and a more realistic view is setting in.”
The issue is that while drugs working through the RNAi mechanism can indeed shut off genes, it has been difficult to deliver such drugs to the cells where they are needed. At a time when hard-pressed pharmaceutical companies are already scaling back research expenditures, RNAi is losing out to alternatives that seem closer to producing marketable drugs.
“I have no doubt that at a certain point in time RNAi will make it to the market,” said Klaus Stein, head of therapeutic modalities for Roche. But he added, “When we looked into this, we came to the conclusion that we have opportunities that have higher priorities.”
More here: Fever to Harness RNA Interference Cools – NYTimes.com.
Cancer Treatments: The New Frontier
by ilene - April 18th, 2010 2:51 pm
Cancer Treatments: The New Frontier
Courtesy of Pharmboy
Cancer is characterized by a group of abnormal cells that grow and replicate uncontrollably. These cells’ rapid replication allows them to invade adjacent tissues and organs and even spread to other parts of the body. As they replicate, they can crowd out organs, preventing the body’s essential processes from occurring normally. Cancer, if left untreated, can hinder the body’s organs from performing their functions enough to cause death.
Cancer is the second leading cause of death in the U.S. in 2009. Figures 1 and 2 show the Male and Female breakdown of different cancer types from the CDC (as of 2006) and we can understand why now prostate and breast cancer research top the list. Next comes lung, and Figure 3 shows a adenocarcinoma in the lung.
Number of deaths for leading causes of death:
- Heart disease: 631,636
- Cancer: 559,888
- Stroke (cerebrovascular diseases): 137,119
- Chronic lower respiratory diseases: 124,583
- Accidents (unintentional injuries): 121,599
- Diabetes: 72,449
- Alzheimer’s disease: 72,432
- Influenza and Pneumonia: 56,326
- Nephritis, nephrotic syndrome, and nephrosis: 45,344
- Septicemia: 34,234
Figure 1. Top 10 Cancers: Male
Figure 2. Top 10 Cancers: Female
Figure 3. Adenocarcinoma – Lung cancer
For about 40 years, the pharmaceutical and government sponsored research have waged a war on cancer, and many think that it has been a failure as the age-adjusted mortality rate for cancer is essentially unchanged over that time. But that’s a deceptive metric. S. Dubner points out that the "flat mortality rate actually hides some good news. Over the same period, age-adjusted mortality from cardiovascular disease has plummeted, from nearly 600 people per 100,000 to well below 300. What does this mean? Many people who in previous generations would have died from heart disease are now living long enough to die from cancer instead."
BusinessWeek had an article on the costs of life, and as the population ages and the baby boomers start to retire, how are we to think about the costs associated with fighting cancer?
Eric C. Sun et al. (“An Economic Evaluation of the War on Cancer” (link) 2010) attempt to measure the degree to which R&D spending on cancer has benefited not only the life expectancy, but also the social and economic value to the economy.
For decades, the U.S. public and private sectors have committed substantial resources towards cancer research, but the societal
Flu Update: Tamiflu resistance and Ukraine update
by ilene - December 20th, 2009 12:52 pm
Roche’s Tamiflu and the Swine Flu
By Ilene
Part I: Tamiflu resistance
Part 2: Flu virus changes/Ukraine/update
Tamiflu (oseltamivir) has been a big seller this year, with global sales soaring 362% to $1.93 billion in the first nine months. Driven by the threats of a swine flu pandemic, governments have been stockpiling the drug to the tune of $1.32 billion. (See Efficacy of Roche’s Flu Drug Tamiflu In Doubt, David Phillips):
According to David Phillips:
Allegations have surfaced that Swiss drug maker Roche has misled governments and physicians alike on the efficacy of its popular drug Tamiflu in preventing complications, such as hospitalization from pneumonia or death, in otherwise healthy people afflicted with the flu — seasonal or the H1N1 (swine flu) version. If the company is unconvincing in refuting such claims, more than its reputation could be sullied.
Leveraging global concerns over avian and swine flu, Roche has seamlessly raised awareness of the purported need to treat the complications associated with the seasonal flu too. The company has successfully challenged conventional wisdom — that “rest and aspirin” be the preferred treatment option for seasonal flu — with marketing campaigns that resonate with reassuring efficacy claims for Tamiflu (oseltamivir)… [See Tamiflu media updates].
A scarcity of published data in the medical literature motivated the nonprofit research group Cochrane Collaboration to investigate — and verify — Tamiflu’s alleged efficacy claims, particularly on the drug’s effect on the risk of hospital admission and complications in otherwise healthy people with influenza. The Cochrane review and a linked investigation undertaken jointly by the British Medical Journal and the local Channel 4 News cast doubt on the efficacy and safety of Tamiflu — and also raises disturbing questions on the drug’s promotional and marketing activities condoned by regulators on both sides of the Atlantic.
Investigators disclosed that an often cited meta-analysis used as evidentiary support was based entirely on ten trials funded by Roche, only two of which were published in peer reviewed journals. The Cochrane reviewers could find no independently funded trials of Tamiflu for healthy adults. Troubling, too, former employees of the medical communcations company hired by Roche were alleged to have ghost written some of the manuscripts….
Continue reading Efficacy of Roche’s Flu Drug Tamiflu In Doubt here .
Roche’s Tamiflu and the Swine Flu
by ilene - December 18th, 2009 10:56 am
Roche’s Tamiflu and the Swine Flu
By Ilene
Tamiflu (oseltamivir) has been a big seller this year, with global sales soaring to $1.93 billion in the first nine months of 2009, a 362 percent increase. Driven by the threats of a swine flu pandemic, governments have been stockpiling the drug to the tune of $1.32 billion. (Efficacy of Roche’s Flu Drug Tamiflu In Doubt)
According to David Phillips:
Allegations have surfaced that Swiss drug maker Roche has misled governments and physicians alike on the efficacy of its popular drug Tamiflu in preventing complications, such as hospitalization from pneumonia or death, in otherwise healthy people afflicted with the flu — seasonal or the H1N1 (swine flu) version. If the company is unconvincing in refuting such claims, more than its reputation could be sullied.
Leveraging global concerns over avian and swine flu, Roche has seamlessly raised awareness of the purported need to treat the complications associated with the seasonal flu too. The company has successfully challenged conventional wisdom — that “rest and aspirin” be the preferred treatment option for seasonal flu — with marketing campaigns that resonate with reassuring efficacy claims for Tamiflu (oseltamivir): reductions in hospital admissions, secondary complications (including bronchitis, pneumonia, and sinusitis), and respiratory tract infections (requiring antibiotics) in otherwise healthy individuals of 61 percent, 67 percent, and 55 percent, respectively, according to Tamiflu media updates.
A scarcity of published data in the medical literature motivated the nonprofit research group Cochrane Collaboration to investigate — and verify — Tamiflu’s alleged efficacy claims, particularly on the drug’s effect on the risk of hospital admission and complications in otherwise healthy people with influenza. The Cochrane review and a linked investigation undertaken jointly by the British Medical Journal and the local Channel 4 News cast doubt on the efficacy and safety of Tamiflu — and also raises disturbing questions on the drug’s promotional and marketing activities condoned by regulators on both sides of the Atlantic.
Investigators disclosed that an often cited meta-analysis used as evidentiary support was based entirely on ten trials funded by Roche, only two of which were published in peer reviewed journals. The Cochrane reviewers could find no independently funded trials of Tamiflu for healthy adults. Troubling, too, former employees of the medical communcations company hired
Our Chatty Cathy Congress
by ilene - November 15th, 2009 1:00 pm
Our Chatty Cathy Congress
By Karen Tumulty, courtesy of TIME
Those of us former little girls of a certain age can remember a doll that we all had to have. She was called Chatty Cathy, and if you pulled a string in her neck, she would say things like "Please brush my hair" and "Let’s have a party!"
It turns out that Chatty Cathy and the United States House of Representatives have a lot in common. Except in Congress’ case, it is the biotechnology industry that has been pulling the string.
In today’s New York Times, Robert Pear has a story that tells us how it happened that more than a dozen lawmakers made virtually the same statement in the official record of the House health care debate. (It’s worth knowing that these are not necessarily speeches they gave on the floor itself, but rather, what gets printed in the Congressional Record when they ask permission to "revise and extend" their remarks. So no one actually hears them say it, but it does go into the official history of the event, and it does put them firmly on record. It also tells the lobbyists’ paymasters that they are getting good return on their investment.)
In this case, the statement in question had actually been written by the biotechnolgy industry--which, as Michael Scherer and I wrote a few weeks back, has been a big winner in the health reform debate, rolling over even such powerful figures as Energy and Commerce Committee Chairman Henry Waxman to get its way. Pear (a reporter whose digging skills are legendary among those of us who have been around Washington a while) tells us:
Genentech, a subsidiary of the Swiss drug giant Roche, estimates that 42 House members picked up some of its talking points — 22 Republicans and 20 Democrats, an unusual bipartisan coup for lobbyists.
In an interview, Representative Bill Pascrell Jr., Democrat of New Jersey, said: “I regret that the language was the same. I did not know it was.” He said he got his statement from his staff and “did not know where they got the information from.”
Members of Congress submit statements for publication in the Congressional Record all the time, often with a decorous request to “revise and extend my remarks.” It is unusual for so