Funding Research on Comparative Effectiveness

From the Wall St. Journal: Coming Soon: Comparative Effectiveness Research for Biotech

Which treatment works best for a given medical condition? The big stimulus package includes $1.1 billion in funding for so-called “comparative-effectiveness” research aimed at answering that question.

Now the NIH has published a list of high-priority projects it wants to fund, providing a clearer picture of just how that money may be spent. The list — online here — suggests scrutiny for some of the best-selling drugs for heart conditions and asthma, among others.

Drugs for auto-immune diseases such as rheumatoid arthritis and psoriasis also make the list. The NIH doesn’t name any of the drugs, but four of the biggest are Enbrel (from Amgen and Wyeth), Remicade (J&J and Schering-Plough), Humira (Abbott) and Orencia (Bristol-Myers Squibb).

They cost anywhere from $10,000 to $25,000 per patient per year, and last year combined U.S. sales of these four were about $9 billion. Yet there have been few, if any, head-to-head trials to see which one works best.

Effectiveness — comparative effectiveness — matters, ethically.

"Hacking" Someone's Genome

From the New Scientist: Special investigation: How my genome was hacked

INTIMATE secrets hidden in your DNA could be stolen without you even realising. By taking a glass from which you have drunk, a "genome hacker" could obtain a comprehensive scan of your genome, revealing DNA variants that help determine your susceptibility to a wide range of diseases, from a common form of blindness to Alzheimer's disease.

That's the disturbing finding of a New Scientist investigation, in which one of us - Michael Reilly - "hacked" the genome of the other - Peter Aldhous - armed with only a credit card, a private email account and a home address.

You might have thought that genome hacking requires specialist skills, and personal access to sophisticated equipment. But in recent years, some companies have started to offer personal genome scans to the public over the internet. Other firms routinely analyse genomes on behalf of scientists involved in human genetics research. In theory, both types of service are vulnerable to abuse by a genome hacker determined to submit someone else's DNA for covert analysis....

OK, their use of the word "hacking" is a bit misleading. Peeking in someone's window isn't "hacking" their bedroom. Anyway, interesting story.

CyClone Dairy: "Perfect Cows. Perfect Milk."

I assume this is a spoof.

Here's what is supposedly the website for CyClone Dairy (a dairy that claims that 100% of its milk comes from cloned cows).

If anyone knows who's behind this, email me.

Salmon Genes & Deliberative Democracy

From the Tyee: Salmon Genes, Discuss

Fish is not something that usually makes us tense, but we didn't know what to expect.

We had invited 26 regular B.C. folk to Vancouver to discuss their hopes and concerns for sequencing the salmon genome. That is, obtaining all the genes in a salmon.

Fine topic for scientists, maybe policy makers, and perhaps salmon farmers. But for retired factory workers, students, nurses and everyday you and me, what would we talk about when we heard Canada, Norway and Chile are planning to decipher the genetic code of the Atlantic salmon?

If you're perplexed by the topic choice, we prayed they wouldn't be. But we were edgy since we hadn't been at many parties where salmon genetics led the conversation. Now we take hope from a comment of one invited guest on what such a gathering of citizens can yield: "Scientists can teach us and maybe we can teach the scientists...."

The page for the research project is here: Sequencing the Salmon Genome: A Deliberative Public Engagement.

Biotech: Health, Food, Manufacturing

Quick comment & question:

The biotech industry (& biotech research more generally) has 3 main areas:

health biotech (new drugs, stem cell research, etc.)
food biotech (GM crops, GM aquaculture, etc.)
industrial biotech (using microbes & enzymes in manufacturing or, for example, in processing textiles or paper)

My sense is that the first gets 90% of the press, and the lion's share of funding too.

My guess is that human health could turn out to be the least important of the 3, in the long run. Just a hunch. Don't quote me. (Roughly: I think food security and the environmental benefits of industrial biotech are more likely to have significant long-term effects on human well-being.)

Doe anyone know where I can get stats on relative levels of investment — public and private — in each of the 3 areas? If so, please email me.

Milk from GM Goats to Fight Intestinal Disease in Brazil

From UC Davis News & Information: U.S.-Brazilian Research Team to Tackle Deadly Intestinal Diseases with Genetically Enhanced Goats' Milk

Scientists in Brazil and at the University of California, Davis, are teaming up to develop a herd of genetically modified dairy goats, whose milk is expected to protect against the types of diarrheal diseases that each year claim the lives of more than 2 million children around the world.

The team plans to have a milk-producing herd of these goats established in Brazil within two years and hopes to begin human trials with the genetically enhanced goats’ milk within three to five years. The milk will carry increased levels of the human enzyme lysozyme. Known to impart important immunological benefits, lysozyme is found at very high levels in human breast milk but at very low levels in goats’ milk.

Pushing Biotech in Europe

From the International Herald Tribune: A new push to win EU acceptance for biotech
First few paragraphs...

The biotechnology industry, claiming the backing of European Union governments, signaled a new effort Monday to win greater leeway to grow genetically modified crops in Europe, a region where citizens have long been skeptical about the safety and value of the technology.

EU experts deadlocked Monday on whether France and Greece should lift their bans on growing the sole bioengineered seed approved for planting: an insect-resistant corn engineered by Monsanto.

Biotechnology industry executives say that a bigger vote expected next week could lead to two additional engineered corn seeds being given permission to be marketed in the EU by year-end. One is produced by Pioneer Hi-Bred International, a unit of DuPont, with Dow AgroSciences. The other is from Syngenta.

Even so, a variety of forces are pushing Europe into re-examining the potential of gene-altered seeds despite a view among many citizens across the trade bloc that the crops are unsafe, dangerous to the environment and represent an unwelcome incursion by corporations into agriculture....

Stem Cell, Public Policy & Innovation

Here's an editorial from the American Enterprise Institute for Public Policy Research: Stem Cells and the Truth About Medical Innovation
First few paragraphs...

Whatever one thinks of the ethics of using human embryos in medical research, the rhetoric around President Barack Obama's decision to expand federal funding for embryonic stem-cell science reveals a widespread misconception of how medical products are created.

Many of the same political leaders who are the strongest champions for federally funded research seek to impose myriad restrictions, regulations, and economic controls on the private companies that translate public science into practical medical innovations. As a result, while Mr. Obama's stem-cell decision only affects federal funding, and while more funding will mean more research, it's far from certain that this will hasten the realization of new medical products.

The achievements of the National Institutes of Health (NIH) are monumental. But its efforts only translate into practical benefits for patients if its scientific research can be turned into new medicines, something that's not part of the agency's mandate. By its own recent count, the NIH cites only 84 examples over the last 60 years where the agency--or academic institutions it supports--discovered, let alone developed, a new drug or biologic.

Making new medicines is the work of a robust private life-science industry. In the case of stem cells, there are more than 150 private companies trying to turn stem cells into new treatments. But almost all of the companies pursuing this sort of chancy science are small biotechnology companies--the kind that rely on private venture capital in order to fund their high-risk and expensive endeavors....

Cheaper Copies of Biotech Meds?

From Reuters: US lawmakers propose generic biotech drug plan

U.S. lawmakers unveiled a bipartisan proposal on Wednesday to allow government approval for cheaper copies of biotechnology medicines that cost as much as tens of thousands of dollars per year.

Representative Henry Waxman, joined by a Democratic colleague and two Republicans, said biotech drugs were the fastest-growing and most expensive part of the nation's prescription drug bill. Generic versions could provide safe alternatives while saving money for patients, employers, insurers and the federal government, the lawmakers said.

If the measure becomes law, it would open a vast new market for generic drugmakers such as Teva Pharmaceutical Industries Ltd (TEVA.TA) and Mylan Inc (MYL.O) and lead to competition for brand-name biotechnology companies.

Biotech drugs, or biologics, are man-made forms of human proteins and tougher to produce than traditional medicines....

Biotech reverse merger: Fair to shareholders?

Biotech ethics isn't all science ethics. This story is about fair treatment of shareholders.

From the San Jose Mercury News: A biotech firm taking a chance on a reverse merger

It is called a reverse merger. And for a failing public biotechnology company, it can represent one last roll of the dice.

The gamble is to merge with a privately held company with better prospects.

The private company takes over the public stock listing and management of the business. The money that the public company had left is then plowed into developing the formerly private company's products. If those products succeed, the shareholders in the old public company can eventually benefit.

Reverse mergers can be used in other ways, as well. The deal that Merck and Schering-Plough announced last Monday, is being done that way to let Schering sidestep a change-of-control clause in a separate drug partnership it has with Johnson & Johnson.

The reverse mergers in biotechnology are meant to help private companies go public at a time when market conditions have made it virtually impossible for them to pursue conventional initial public offerings....

South African Law re Forensic Genetic Tests

Check this opinion piece, from the South African newspaper, The Times: Forensics bill raises ethics issues

Proposed law is not strict enough when it comes to access to people’s genetic coding, leaving this open to exploitation and abuse, writes Mary de Haas
The Criminal Law (Forensics Procedures) Amendment Bill of 2009, which includes provisions for the establishment of a national DNA database, is being marketed as an indispensable tool in the fight against crime.
But, as crucial as DNA can be in showing innocence or guilt, this bill should definitely not be passed in its present form. It does not sufficiently address issues relating to individual and family privacy, and some of its provisions are unethical. It also places far too much power in the hands of the SA Police Service without adequate oversight.

Top 30 Innovations of the Last 30 Years?

From Knowledge@Wharton: A World Transformed: What Are the Top 30 Innovations of the Last 30 Years?

Is it possible to determine which 30 innovations have changed life most dramatically during the past 30 years? That is the question that Nightly Business Report, the Emmy Award-winning PBS business program, and Knowledge@Wharton set out to answer to celebrate NBR's 30th anniversary this year. NBR partnered with Knowledge@Wharton to create a list of the "Top 30 Innovations of the Last 30 Years."

Here's their list:

1. Internet, broadband, WWW (browser and html)
   
2. PC/laptop computers
   
3. Mobile phones
   
4. E-mail
   
5. DNA testing and sequencing/Human genome mapping
   
6. Magnetic Resonance Imaging (MRI)
   
7. Microprocessors
   
8. Fiber optics
   
9. Office software (spreadsheets, word processors)
   
10. Non-invasive laser/robotic surgery (laparoscopy)
    
11. Open source software and services (e.g., Linux, Wikipedia)
    
12. Light emitting diodes
    
13. Liquid crystal display (LCD)
    
14. GPS systems
    
15. Online shopping/ecommerce/auctions (e.g., eBay)
    
16. Media file compression (jpeg, mpeg, mp3)
    
17. Microfinance
    
18. Photovoltaic Solar Energy
    
19. Large scale wind turbines
    
20. Social networking via the Internet
    
21. Graphic user interface (GUI)
    
22. Digital photography/videography
    
23. RFID and applications (e.g., EZ Pass)
    
24. Genetically modified plants
    
25. Bio fuels
    
26. Bar codes and scanners
    
27. ATMs
    
28. Stents
    
29. SRAM flash memory
    
30. Anti retroviral treatment for AIDS
    

Notice that biotech takes #5, #24, #25, and #30. Hard not to suspect that the list 30 years from now will be a little more biotech-heavy.

Clinic Won't Offer 'Designer Babies' After All

From Fox News: After Criticism, Fertility Clinic Halts Delivery of Designer Babies

The Fertility Institutes in Los Angeles, which last month said it would soon help couples select a baby's gender and physical traits when undergoing a form of fertility treatment, has announced it will no longer proceed with the project.

The clinic, which has locations in Los Angeles, Mexico and New York, told the Wall Street Journal last month it had received a half-dozen requests for babies with specific physical characteristics.
...
But the clinic's Web site, has now posted its "Latest News":

“In response to feedback received related to our plans to introduce preimplantation genetic prediction of eye pigmentation, an internal, self-regulatory decision has been made to proceed no further with this project...."

Overseas Clinical Trials: legal, regulatory, ethical and cultural questions

Here are two bioindustry lawyers, writing in Bioworld: What to Think About When Considering an Overseas Clinical Trial Program

To remain competitive, drug, device and biotechnology companies must continually pursue innovative new products and product improvements. Clinical trials are essential to the development of new medical products and require the investment of tremendous time and resources — with no guarantee of success. In 2007, biotechnology and pharmaceutical companies spent approximately $58.8 billion on research and development efforts, with clinical trials typically consuming 40 percent or more of the research and development budget.

This enormous investment in time and money has caused drug companies to explore opportunities to lower the costs and shorten the timelines of their clinical trial programs. It is, therefore, no surprise that pharmaceutical companies in the U.S. have steadily increased the number of clinical trials they conduct overseas, with a focus on jurisdictions promising cost savings and recruitment efficiencies, such as those located in Central and Eastern Europe (CEE). While U.S. companies can realize significant benefits by conducting a clinical trial in the CEE and other foreign jurisdictions, they also must consider the myriad of legal, regulatory, ethical and cultural questions they will invariably encounter in setting up and conducting a clinical trial abroad. U.S. companies also must be aware that FDA is increasing its scrutiny of foreign clinical trial data. In April 2008, FDA amended its foreign clinical trial regulations to ensure "the quality and integrity of foreign clinical data supporting FDA decision making on product applications and to help ensure the protection of human subjects participating in foreign clinical trials...."

For those of us who are outsider observers of the bio-pharma industry, it's useful to see discussions among insiders once in a while.

Growth in Gene Tests

From Genetic Future: Growth in commercial disease gene tests, 2008 update...

I just noticed that GeneTests, a voluntary listing of US and international laboratories offering in-house genetic tests, has released an updated version of their graph of commercially available tests:

Lomborg: GM Food for the World's Malnourished

From Bjorn Lomborg, writing in City: Another Green Revolution

Shortly after the Second World War, a “Green Revolution” began to transform agriculture around the globe, allowing food production to keep pace with worldwide population growth. By means of irrigation, fertilizer, pesticides, and plant breeding, the Green Revolution increased world grain production by an astonishing 250 percent between 1950 and 1984, raising the calorie intake of the world’s poorest people and averting serious famines. The revolution’s benefits have tapered off, however, as the number of mouths to feed has grown ever larger and as conventional breeding of new plant varieties has produced diminishing returns. What’s needed is a new revolution. Luckily, most agricultural scientists believe that the planet’s requirements for agricultural production could be met through genetic modification (GM)—if environmental activists don’t keep it from happening.

I've written positive things about GM foods. But I think Lomborg is overselling the benefits, here.

Secret DNA Tests

From The Orlando Sentinel: Genetic privacy: Who is testing your DNA?

Test Infidelity is just one of dozens of U.S. companies offering to test DNA taken without the knowledge of the people concerned. Many firms advertise infidelity testing services or offer "discreet" paternity tests. These allow a man to determine whether he is the father of a child without letting anyone else know what he is up to, or a woman to tell whether a man is the father of her child without involving him in the process.

While the total number of stealthy DNA tests being conducted is unclear, interviews with genetic testing companies indicate that thousands are being run each year in the United States alone.

Anti-Biotech Group: Killing Biotech Board Bad Idea

Press release: Abandoning Bio-Ethics Will Damage New Zealand

Friday, 13 March 2009, 9:48 am
Press Release: GE Free NZ
GE Free New Zealand
In Food And Environment Inc.
www.gefree.org.nz

Abandoning Bio-Ethics Will Damage New Zealand

New Zealand's world-wide reputation will be undermined if the government proceeds with its plan to terminate the Bio-Ethics Council and seeks to loosen legislated safeguards around the use of biotechnology.

"It is alarming to see the shutting down of public participation and the right for people to express their views on moral and ethical issues around highly contentious matters that affect their lives and those of future generations," says Claire Bleakley from GE Free NZ in food and environment....

Google Founder Funds 23andMe Research on Parkinson's

Google Co-Founder Backs Vast Parkinson’s Study

Sergey Brin, the billionaire co-founder of Google, says he plans to contribute money and his DNA to a large study intended to reveal the genetic underpinnings of Parkinson’s disease.

The study, to be announced Thursday, will be conducted by 23andMe, a company co-founded and co-managed by Mr. Brin’s wife, Anne Wojcicki. The company offers a personal genomics service, in which it scans the DNA submitted by its customers and provides information on their health risks, ancestry and other traits.

Now it hopes to use its service and its growing database of consumer DNA to conduct medical research. The company hopes to recruit 10,000 people with Parkinson’s disease for the study.

For more on 23andMe, see: Personal Genomics: the Ethics of Shared Uncertainty

For use of social networks in research, see:
Therapeutic Misconception, Personalized Genetics, & Breast Cancer Research
and
Want to find out what makes you "stand out from the crowd"? Consider signing up for a research study!

No Violating Laws of Physics, Please

The biotech industry is famous for hype. But even the most enthusiastic sales-pitch should stop short of implying that a company can violate the laws of physics. For example:

From Nature Biotech (Jan. 2009) Biotech’s green gold?

Valcent Products, a public company located in Vancouver, is experimenting with a range of algal species in enclosed bioreactors. Valcent CEO Glen Kertz says he can sell a barrel of algal oil for less than a barrel of crude oil and that his system has the potential to produce 100,000 gal/ac/yr.

“I said to him [Kertz], ‘You are not doing anyone any favors by making absurd claims’,” says Scripps’ Mayfield. “That is five times the theoretical maximum energy from sunlight landing on an acre. It’s physically impossible to do that.” No outside experts have been allowed to validate the system yet, according to Kertz.

Yeah, telling prospective investors that you can violate the laws of thermodynamics probably isn't fully ethical.

Artificial Life: Soon?

From The Telegraph: Artificial life 'could be created within five years'

Laboratories across the world are closing in on a "second genesis" - an achievement that would be one of the greatest scientific breakthroughs of all time.
Prof David Deamer, from California University, said although building a new lifeform from scratch is a daunting task he is confident it can happen in five to 10 years.

He said: "The momentum is building - we're knocking at the door."
A synthetic, made-to-order living system could produce everything from new drugs to biofuels and greenhouse gas absorbers.
Opponents of the controversial research claim the technology could lead to machines becoming "almost human".

U.S. Reconsidering Gene Patents?

From GenomeWeb Daily News: HHS Committee Opens Public Comment on Gene Patents

A National Institutes of Health task force has released a draft report on its findings about the effects of gene patenting on medicine, research, and business, and has issued a set of potential policy options for public consideration as part of the report.

The Secretary's Advisory Committee on Genetics, Health, and Society, which meets this week to discuss a number of other genomics-related issues, will seek public comments until May 15, 2009, on the findings and policy options drafted by its task force.

The SACGHS task force worked with Duke University's Center for Genome Ethics to draft policy options based on a variety of findings from case studies of certain tests, companies, illnesses, and research areas.

The participation of the smart folks at Duke is a good sign.

Biotech for Africa: McLaughlin-Rotman Centre publications

2 new publications out of the McLaughlin-Rotman Centre for Global Health:

From Nature Biotech: A survey of South-North health biotech collaboration

In recent years, biotech companies in North America and Europe have increasingly looked to developing countries to find new partners and develop new collaborations. Even though the growth rates of emerging economies like China and India, as well as several sub-Saharan African countries, have been hampered by the current global recession, over the past five years their economies have grown faster than economies anywhere else in the world. This growth has been reflected by growing indigenous private sectors in health biotech that are also taking active steps to strengthen their innovation capabilities, thereby allowing collaboration to become a two-way street.

And from The Africa Journal: Accelerating African Health Innovation

Effective investments in science, technology, and innovation have the potential to provide long term solutions to Africa’s disease burden. However, to date the Continent has been unable to capture the social and economic potential of science and technology. While Africa is more successful at health research, it is not as successful in commercializing that research into health products aimed at local and regional health problems. To fully harness the potential of indigenous research and development, the barriers that limit commercialization must be better understood and addressed.

Pricing: NICE vs GSK

From pharmiweb.com: NICE AND GSK GO HEAD-TO-HEAD ON DRUG PRICING AT BUPA HEALTH DEBATE

The National Institute for Health and Clinical Excellence (NICE), the body that approves drugs for the NHS, will go head-to-head with pharmaceutical giant GlaxoSmithKline (GSK) on the issue of drug pricing at the 2009 Bupa Health Debate on 25 March. The debate pits Professor Sir Michael Rawlins, chairman of NICE against Simon Jose, senior vice president of UK pharmaceuticals at GSK, at a time when conflict between the two organisations escalates over Tyverb, a GSK breast cancer drug. NICE is refusing to approve Tyverb because it is “not a cost-effective use of NHS resources”, despite GSK’s offer to fund the drug for the first 12 weeks of treatment.

This is just one example of 'life or death' decisions NICE takes over which drugs to approve for use on the NHS, as it battles to make best use of the limited NHS resources for new medicines. But pharmaceutical companies argue that the prices they charge for new drugs are a fair reflection of their multi-million pound investment in research and development.

Escalating drug prices is not just a UK problem. ...

Pricing is a hard ethical problem, partly because there's so little good scholarly work on the problem.

Denial of insurance, on genetic grounds (Australia)

Australians refused insurance because of poor genes

AUSTRALIANS have been refused insurance protection because of their genetic make-up, researchers have shown in the first study in the world to provide proof of genetic discrimination.

Most cases were found to relate to life insurance. In one instance, a man with a faulty gene linked to a greater risk of breast and prostate cancer was denied income protection and trauma insurance that would have let him claim if he developed other forms of cancer.

The findings have led to renewed calls by experts for policies to ensure the appropriate use of genetic test results by the insurance industry.

GeoEngineering (And its Biotech Components)

From Marc Gunther: Geoengineering: Time to get serious?

Imagine a fleet of 1,500 remote-controlled, wind-powered ships, sailing the world’s oceans, spewing salt water into the air to whiten clouds, so they block more of the sun and cool an overheating planet.

Or think of trillions of tiny mirrors, sent into orbit, to reflect the sun’s rays. Or artificial trees that suck a ton of carbon a day out of the atmosphere. Or iron filings, sprinkled on seas, to rapidly grow phytoplankton, which absorb CO2.

These emergency strategies for curbing global warming aren’t crazy schemes. Well, maybe they are crazy schemes. But serious people say we should start taking them seriously, as a last-ditch option to deal with the threat of catastrophic climate disruptions....

Quite a few of the relevant options, it seems, will make some use of biotechnology.

GM Seeds in Afghanistan

From the Organic Consumers' Association:

In this Briefing, we look at how the US's agricultural reconstruction work in Afghanistan and Iraq not only gives easy entry to US agribusiness and pushes neoliberal policies, something that has always been a primary function of US development assistance, but is also an intrinsic part of the US military campaign in these countries and the surrounding regions.
....
In Afghanistan NEI works with Stine Seed Company, Iowa, and Gateway Seed Company, Illinois, both of which supply it with genetically modified Roundup soya and Roundup-Ready herbicide to be sold on to the farmers. According to NEI, it distributed two tonnes of genetically modified soya seed in Afghanistan in 2005.

I assume they're saying this is a bad thing.

"Death Penalty" Advocated For Eli Lilly

From AlterNet.org: The Case for Giving Eli Lilly the Corporate Death Penalty

Eli Lilly & Company's rap sheet as a public menace is so long that for Lilly watchers to overcome the "banality-of-Lilly-sleaziness" phenomenon, the drug company must break some type of record measuring egregiousness. Lilly obliged earlier this year, receiving the largest criminal fine ever imposed on a corporation.

If Americans are ever going to revoke the publicly granted charters of reckless, giant corporations -- well within our rights -- we might want to get the ball rolling with Lilly, whose recent actions appalled even the mainstream media. And with Lilly's chums, the Bush family, out of power, now might be the right time.

Biotech Ethics vs Pharma Ethics

From a few months ago, but a great question: Will biotech change pharma ethics?

Big pharma is continuing to absorb the biotech sector, as the drama over ImClone makes clear.
...
So perhaps it is no coincidence that medical schools are now leading a charge for a higher ethical standard in the industry. Biotechs have long worked under an ethical cloud, one requiring an ethical sensibility.

Can they change things, or will pharma change them instead?

I've worried about this for a long time. Biotech faces ethical challenges, but its track record isn't bad. The pharma industry's is awful. The promise of biotech is threatened, I think, by the lousy ethics of the industry that's absorbing it.

Medical Devices & FDA

This isn't a biotech story, but relevant to those in the biotech industry who manufacture medical devices:
Wall Street Journal: Political Lobbying Drove FDA Process

The recent approval of a new device to treat knee injuries followed a lobbying campaign that overcame repeated rejections by scientists within the Food and Drug Administration, agency documents show.

The FDA's internal dissent over Menaflex, which targets the most-common knee injury afflicting everyone from high-school athletes to baby boomers, is straining a government agency that oversees a quarter of the U.S. economy. Some senior FDA staff members complained in documents that the handling of Menaflex, made by ReGen Biologics Inc., shows how political and industry pressure can influence scientific conclusions.

Nanofoods

From the website CHOICE: Trusted information for Australian consumers: Nanotechnology and food

”Nanofoods” refers to all foods to which manufactured nanoscale food components have been added and/or packaged in materials to which manufactured nanoparticles have been added. Nanotechnology certainly offers exciting possibilities for the future, such as safer food that can be conveniently stored for longer periods without deterioration. Other possibilities include foods fortified with healthy ingredients such as vitamins, antioxidants or omega-3 fats, encapsulated so that they are delivered exactly where they are needed in your body.
....
The main issue around regulation is not the small size of nanoparticles as such, rather their novel properties. We’ve always been exposed to naturally occurring nanoparticles, but never before to nanoparticles specifically manufactured to influence food properties. We simply do not yet know enough about how they could affect human health; no one predicted, for example, that carbon nanotubes could cause cancer ....

WSJ reports on falsified painkiller studies

Hospital Says Fake Data Used in Painkiller Studies

A prominent Massachusetts anesthesiologist allegedly fabricated 21 medical studies that claimed to show benefits from painkillers like Vioxx and Celebrex, according to the hospital where he worked.

Baystate Medical Center, Springfield, Mass., said that its former chief of acute pain, Scott S. Reuben, had faked data used in the studies, which were published in several anesthesiology journals between 1996 and 2008.

Falsifying Data in Anesthesiology

From the Research Ethics Blog: Falsifying Data: Anesthesiology Research May Have Found its Own Bernie Madoff

You all know who Bernie Madoff is. He's the guy who pulled off the biggest financial scam in history. Madoff's scam wasn't just big. It was enormous. Mind-boggling. How, everyone asked, did he pull it off? And beyond that, what made him think he could get away with it?

Now, it looks like the field of Anesthesiology research may have its own Bernie Madoff, in the person of one Scott S Reuben, MD.

The story comes from Anesthesiology News, and reported repeated the Pharmola.com website: Fraud Case Rocks Anesthesiology Community

Ethics of Personal Genomics

From the Business Ethics Blog: Personal Genomics: the Ethics of Shared Uncertainty

Yesterday afternoon I gave a talk there, called "Direct-to-Consumer Genetic Testing: Consumer Empowerment or High-Tech Fortune-Telling?"

I didn't talk about genetic testing in general, but rather specifically about at-home genetic tests (a.k.a. "personal genomics" services) sold by companies like 23andMe, Navigenics, and deCode.

The scientific consensus (among academic and clinical geneticists, anyway) seems to be that such tests aren't worth much.