Anti-Innovation Bias in the New York Times

The headline on the New York Times “Green” blog post read “A Limit to Gains From Genetically Engineered Cotton.”   Sounds dark and foreboding, doesn’t it?

In fact, the research study cited by the blog post was  a highly-positive long-term study of the value of genetically engineered cotton in India.  The study closely examined the yields on small farms in India and concluded:

Building on unique panel data collected between 2002 and 2008, and controlling for nonrandom selection bias in technology adoption, we show that Bt has caused a 24% increase in cotton yield per acre through reduced pest damage and a 50% gain in cotton profit among smallholders. These benefits are stable; there are even indications that they have increased over time. We further show that Bt cotton adoption has raised consumption expenditures, a common measure of household living standard, by 18% during the 2006–2008 period. We conclude that Bt cotton has created large and sustainable benefits, which contribute to positive economic and social development in India.

Now, I ask you…does that study sound like it deserves a post with a negative headline?

A better, more accurate headline would have been “Genetically modified cotton shown to raise long-term living standards for small farmers in India. ”   An item on the Nature website, based off the same study, used the headline, “Genetically modified cotton gets high marks in India.”

Or, if you want the forward spin, “Can new technologies keep farm incomes rising in India?”  Or,  “Should activists rethink opposition to GM crops?”

This is not just nitpicking.  The only way out of our current economic malaise is innovation–innovation in IT, innovation in biosciences, innovation in energy.  From that perspective, an anti-innovation bias at the NYT is also anti-growth and pro-stagnation.

 

FDA Reverses Course on Melafind

Remember that a couple of months ago I wrote a piece about FDA overregulation, applied to the particular case of Melafind, a handheld computer vision system intended to help dermatologists decide which suspicious skin lesions should be biopsied for potential melanoma a system for assessing. The FDA’s original response to Melafind had been to deem it  “not approvable,” saying that MelaFind “puts the health of the public at risk.”

In my piece I analyzed why the FDA had unreasonable and contradictory expectations for Melafind. I then testified before a Congressional subcommittee on the subject.

Well, the FDA has surprisingly changed its mind. From the WSJ today:

Doctors in the coming months are likely to have a new tool to diagnose the deadly skin cancer melanoma, after the Food and Drug Administration reversed its earlier decision and said the MelaFind device was “approvable,” pending some final negotiations.

The FDA cleared the path for approval in a letter it sent to Mela Sciences Inc. Thursday night. The letter hasn’t previously been disclosed.

More to follow.

The Real Implication of the Niaspan Study (or why I’m going to boost my biosciences investments)

Yesterday we had bad news about Niaspan:

The NIH has stopped a study with Abbott Laboratories’ cholesterol fighter Niaspan 18 months early after results showed the drug failed to prevent heart attacks and even may have boosted stroke risk. And as Bloomberg notes, the results could heighten the debate over whether raising good cholesterol actually helps patients….

….In a study follow-up, participants who took Niaspan and simvastatin had increased HDL cholesterol and lowered triglyceride levels compared to participants who took a statin alone. But the combination treatment failed to reduce heart attacks, strokes, hospitalizations for acute coronary syndromen or revascularization procedures to improve blood flow in the arteries of the heart and brain.

Certainly Abbott stock will fall in the short run. But in the big picture, this is an important step forward in the long and excruciating process of sorting out fact from fiction.  It fits in with the stream of stories like this one, which finds yet another biochemical mechanism that people had not suspected. 
 
The central dogma in molecular biology states that DNA is copied into RNA, one nucleotide at a time. But it turns out that copy may be a lot less exact than scientists previously thought. ….A new paper, published today in Science,identifies widespread differences between DNA sequences and their corresponding RNA transcripts in human cells, and demonstrates that these differences result in proteins that do not precisely match the genes that encode them. 
When pharma companies embraced genomics, they thought they had a faster path to finding new drugs that would treat well-known and well-understood problems.  Unfortunately, the deeper they got in, the more they discovered was that the problems were actually not well-understood–that conventional medical understanding was simply not correct much of the time.  This fits in with the lesson of evidence-based medicine so far,  which is that we know less than we thought we did. For example,  here’s what a panel of experts recently concluded about diet, lifestyle, and Alzheimer’s:
Although numerous studies have investigated risk factors and potential therapies for Alzheimer’s disease, significant gaps in scientific knowledge exist,” Dr. Martha Daviglus of Northwestern University Feinberg School of Medicine, Chicago, and colleagues wrote in the Archives of Neurology.

“Currently, firm conclusions simply cannot be drawn about the association of any modifiable risk factor with Alzheimer’s disease, and there is insufficient evidence to support the use of any lifestyle interventions or dietary supplements to prevent Alzheimer’s,” the panel wrote.

It turns out we are building a bridge across a wide and deep canyon rather than a narrow ravine.  Researchers are on the canyon floor, putting in the foundations and supports that no one thought we needed.  It’s a long, expensive, depressing, and dangerous process.

But there will come a moment–maybe soon, maybe years from now–when the bridge  will be, not done, but usable.  Traffic across the once-impassable canyon will soar almost overnight, and the Biosciences Century will truly begin.  And I, for one, want to be invested in those companies when that happens.

Right Diagnosis, Wrong Prescription: New Medical Research Center

Back in June, I argued that the most significant economic event of the past decade was “the failure of the Human Genome Project to  thus far deliver medically significant results.”  I was soundly attacked at that time by all sorts of people, some of  arguing that I was an idiot because there was plenty of innovation in the biosciences, and others arguing that I was an idiot because biosciences didn’t matter that much.

Now NIH has woken up and realized that the research breakthroughs in genonomics have not translated into cutting edge medicines. But rather than address the real problems–including excess regulation at the FDA–the decision was made to create a new government agency in competition with the drug companies. From today’s NY Times piece.

The Obama administration has become so concerned about the slowing pace of new drugs coming out of the pharmaceutical industry that officials have decided to start a billion-dollar government drug development center to help create medicines.

<snip>

Creating the center is a signature effort of Dr. Collins, who once directed the agency’s Human Genome Project. Dr. Collins has been predicting for years that gene sequencing will lead to a vast array of new treatments, but years of effort and tens of billions of dollars in financing by drug makers in gene-related research has largely been a bust.

As a result, industry has become far less willing to follow the latest genetic advances with expensive clinical trials. Rather than wait longer, Dr. Collins has decided that the government can start the work itself.

Dr. Collins, this is so not the right move. Why not put some of your prestige towards untangling the regulations that make it more and more expensive for drug companies to get approvals?

Procyclical Regulation at FDA?

From a year end WSJ piece entitled “Drug Approvals Slipped in 2010”: (my emphasis added)

A few potential blockbusters won approval during the year, but some of the most highly anticipated new products got delayed into next year or beyond. That partly reflects a tougher environment at the FDA, with regulators stepping up their scrutiny of safety issues in drugs for obesity, diabetes and other conditions.

According to monthly drug-approval reports on the FDA’s website, 21 new drugs were approved in 2010, down from 25 in 2009 and 24 in 2008, but higher from a recent low of 18 in 2007.

What’s going on is a kind of vicious circle, unfortunately. As the drug companies struggle to turn cutting-edge science into blockbuster products,  regulators get more skeptical. And as regulators get more skeptical, they tighten up their scrutiny, which makes the task of the drug companies that much more difficult.

Added. More on this subject from the San-Diego Union Tribune, 2010 drug approval extends frustrating trend for biotech companies,

Some people in the biotechnology industry have complained that FDA officials are putting too much emphasis on potential or perceived safety issues and aren’t giving enough attention to bringing innovative therapies to market.

“There has to be a balance, and that balance doesn’t seem to have been there over the last year or two,” said Joe Panetta, president and chief executive of the San Diego-based trade group Biocom.

The critics say the decline in new drug approvals has helped cut private investment in drug developers and prompted some companies to seek initial approval of their new therapies in Europe and Japan, where they face speedier and less onerous review processes.

“It could be that we shove the (biotechnology) industry to other countries and reduce the availability of breakthroughs” in the United States, said Tim Wollaeger, a managing director with the biomedical venture capital firm Sanderling Ventures.

Broad Institute and the Future of the Economy

To me,  the long-term success of the U.S. economy is closely connected with biosciences. I was just reading a Boston Globe article on the Broad Institute:

Since its founding in 2003, the Broad has exploded into a major research hub, with a team of 1,500 scientists and staff, deep pockets, and the goal of leveraging mind-boggling amounts of information to understand and abolish some of humanity’s most complicated and seemingly intractable diseases: diabetes, cancer, schizophrenia.

But with big ambitions come big risks. The Broad’s founders have made what amounts to a bet, with hundreds of millions of dollars from government and private donors: that this kind of large-scale biology will be the key to realizing the human genome project’s promise to transform human health and medicine.

There have been indisputable achievements: Broad scientists have found genes underpinning human diseases; have sequenced the genomes of more than 15 mammals, from dogs to horses; and are leaders in an international effort to compile the genomes of 1,000 people.

But even as discoveries raise the public’s hopes that new treatments are near, the research has so far illuminated not an easy path to curing disease, but immense complexity. In most cases, disease genes contribute in only a small way to the risk of illness, and some scientists have begun to question whether the big biology pursued at the Broad and elsewhere is drawing money from traditional research that might be more fruitful.

I simply don’t know the answer here. I’m not even sure of the right question.  The Broad Institute is tackling tough and complex problems head-on with lots of money and new technology, which seems like the right strategy to me.  Has the approach not worked? Is it too soon to tell?  Or is the Broad Institute going to  be like Xerox Parc and Bell Labs–creating a lot of tools for others to use?

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