Biotech Ethics

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.

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.

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.

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.

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.

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.

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….

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….

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 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….