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The Genius Who Helped Unlock the Human Genome Is Taking On the Opioid Crisis

Mother Jones

Francis Collins, the gregarious 67-year-old who directs the National Institutes of Health, doesn’t shy away from a challenge. Collins made a name for himself in the early 2000s when, as director of the Human Genome Project, he oversaw the completion of sequencing 3 billion genes. Now, as the head of the nation’s foremost biomedical research engine, Collins faces a new task: finding solutions to the opioid epidemic, which killed more than 33,000 Americans in 2015.

At the Prescription Drug Abuse and Heroin Conference last month, Collins announced a public-private partnership, in which the NIH will collaborate with biomedical and pharmaceutical companies to develop solutions to the crisis. President Donald Trump and Health and Human Services Secretary Tom Price “strongly supported” the idea, he said. This isn’t Collins’ first such partnership: During his tenure as director—Barack Obama appointed him in 2009—Collins has developed ongoing collaborations with pharmaceutical companies such as Lilly, Merck, and GlaxoSmithKline for Alzheimer’s disease, diabetes, and rheumatoid arthritis. For each partnership, the NIH and the companies pool tens of millions of dollars, with the agreement that the resulting data will be public and the companies will not immediately patent treatments. The jury’s still out on results—the partnerships are about halfway through their five-year timelines. But Collins, a self-described optimist, remains hopeful. “Traditionally it takes many years to go from an idea about a drug target to an approved drug,” said Collins at the conference. “Yet I believe…a vigorous public private partnership could cut that time maybe even in half.”

I talked to Collins about the partnership, potential treatments in the pipeline, and the NIH’s role in confronting the ongoing epidemic.

Mother Jones: Why is a public-private partnership needed?

Francis Collins: While NIH can do a lot of the good science, and we can accelerate it if we have resources, we aren’t going to be the ones making pills. Many of the large-scale clinical trials are not done generally by us but by the drug companies. A successful outcome here—in terms of ultimately getting rid of opioids and the deaths that they cause—would not happen without full engagement by the private sector.

MJ: Which companies will be involved?

FC: It will be a significant proportion of the largest companies. I can’t tell you the total list—as I said, the 15 largest were there. Certainly the groups that already have some drugs that are somewhere in the pipeline will be particularly interested in ways to speed that up.

MJ: What do you hope will come out of it in the short term?

FC: I think that we could increase the number of effective options to help people get over addiction, and the treatments for overdose, particularly when fentanyl is becoming such a prominent part of this dangerous situation. The current overdose treatments are not necessarily as strong as they need to be. We could make progress there pretty quickly, I think—in a matter of even a year or two—by coming up with formulations of drugs that we know work but in a fashion that would have new kinds of capabilities. The drugs would be stronger, as in the overdose situation, or have the potential of longer-acting effects, as in treating addiction. It’s not necessarily a different drug, but a different formulation of the drug. And drug companies are pretty good at that.

MJ: And in the long term?

FC: The goal really needs to be to find nonaddictive but highly potent pain medicines that can replace the use of opioids given the terrible consequences that surround their use. This will be particularly important for people who have chronic pain, where we really don’t have effective treatments now. The good news is that there’s a lot of really interesting science pointing us to new alternatives, like the idea of coming up with something that interacts with that opioid receptor but only activates the pathway that results in pain relief—not the somewhat different pathway that results in addiction. That’s a pretty new discovery that could actually be workable, and a lot of effort ought to be put into that.

I’d like all of us, the academics, the government, and the private sector, to think about this the way we thought about HIV/AIDs in the early 1990s, where people were dying all around us in tens of thousands. Well, that’s what’s happening now with opioids. This ought to be all hands on deck—what could we do to accelerate what otherwise might take a lot longer? It’s interesting talking to the drug companies, who have really gotten quite motivated and seem to be determined to make a real contribution here. There are quite a number of new drugs that are in the pipeline somewhere, and they haven’t been moving very quickly, because companies haven’t been convinced there was enough of a market—opioids are relatively cheap. And also they’ve been worried that it would be hard to get new pain medicines approved if they had any side effects at all. Now that we’ve seen opioids have the most terrible side effect of all—namely, death—it would seem that as new analgesics come along, that the ability to approve some that might give you a stomachache now and then would probably be better.

MJ: There’s a lot of wariness of big pharmaceutical companies right now, given Big Pharma’s role in creating this problem to begin with. How do you make sure that whatever treatments are developed are affordable?

FC: That’s a very big concern for everybody right now. It’s front and center in these discussions about development of new drugs and pricing of existing drugs. And I don’t know the full answer to that. This is just part of a larger discussion about drug pricing which applies across the board, whether we’re talking about drugs for cardiovascular disease or cancer or, in this case, alternatives for opioids. But we need them. As much as people might want to say, “Oh, pharmaceutical companies, they’re all just out to make money,” they also have the scientific capabilities and they spend about twice what the government does on research and development. If they weren’t there, we’d be completely hopeless as far as new treatment.

MJ: Trump’s latest budget proposes a 20 percent cut to the NIH for 2018. Are you worried about having enough funding?

FC: Of course I am. And not just for this, but for all the other things that NIH is called upon to do as part of our mission. I’m an optimist, and what I have seen in my 24 years at NIH is that opportunity in medical research is not a partisan issue—it’s not something that’s caught up in politics most of the time. And having seen the enthusiasm represented by the Congress in their passage of the 21st Century Cures Act just four months ago with incredible positive bipartisan margins, I think when the dust all settles, people will look at these kinds of investments and see them as a high priority for our nation. But of course, that’s my optimistic view.

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The Genius Who Helped Unlock the Human Genome Is Taking On the Opioid Crisis

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Scientists Condemn New FDA Study Saying BPA Is Safe: "It Borders on Scientific Misconduct"

Mother Jones

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In February, a group of Food and Drug Administration scientists published a study finding that low-level exposure to the common plastic additive bisphenol A (BPA) is safe. The media, the chemical industry, and FDA officials touted this as evidence that long-standing concerns about the health effects of BPA were unfounded. (“BPA Is A-Okay, Says FDA,” read one Forbes headline.) But, behind the scenes, a dozen leading academic scientists who had been working with the FDA on a related project were fuming over the study’s release—partly because they believed the agency had â&#128;&#139;bungled the experiment.


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On a conference call the previous summer, officials from the FDA and the National Institutes of Health (NIH) had informed these researchers that the lab where the study was housed was contaminated. As a result, all of the animals—including the supposedly unexposed control group—had been exposed to BPA. The FDA made the case that this didn’t affect the outcome, but their academic counterparts believed it cast serious doubt on the study’s findings. “It’s basic science,” says Gail S. Prins, a professor of physiology at the University of Illinois at Chicago, who was on the call. “If your controls are contaminated, you’ve got a failed experiment and the data should be discarded. I’m baffled that any journal would even publish this.”

Yet the FDA study glossed over this detail, which was buried near the end of the paper. Prins and her colleagues also complain that the paper omitted key information—including the fact that some of them had found dramatic effects in the same group of animals. “The way the FDA presented its findings is so disingenuous,” says one scientist, who works closely with the agency. “It borders on scientific misconduct.”

Perhaps more importantly, the group worries that the fallout from the flawed paper could undermine their collaborative study—a $32 million taxpayer-funded project known a CLARITY-BPA, which is supposed to pinpoint the most effective methods for assessing the effects of BPA and ensure they shape regulation. “The FDA is essentially preempting our findings,” says Prins, who is on the CLARITY team. “Right now, people are being told that BPA is harmless. As the CLARITY data trickles out over the next few years, the public is just going to be confused.”

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Scientists Condemn New FDA Study Saying BPA Is Safe: "It Borders on Scientific Misconduct"

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Chart of the Day: We Are Deliberately Destroying Our Medical Future

Mother Jones

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Over at Pacific Standard—a pretty good magazine that you should check out—Michael White shows us what’s happened to the National Insitutes of Health ever since 1998, when Congress decided on a bipartisan basis to double its research budget over five years. The budget was indeed doubled, but when the five years was up its funding was immediately put back on its old path. Then, when the recession hit, it was cut even further:

The tighter competition for funding has put the squeeze on younger scientists with fledgling labs; the proportion of young scientists with NIH grants is half of what was in 1998, while the proportion of funded scientists over 65 has doubled. Because scientific training typically takes over 10 years, students who decided to enter graduate school in the boom days of the mid-Aughts are now entering a job market that looks nothing like what they expected.

Keith Humphreys adds more:

On the ground in my daily work in both a university medical school and a public hospital, it’s a rare month that some bright young person doesn’t tell me they are quitting science because it’s too hard to get funded. These are usually not reversible decisions. Even a well-trained young physician who leaves research for 5 years to treat patients full-time is very hard to tempt back into science if the funding picture improves (and is even harder to bring back up to speed on the cutting-edge scientific questions and methods of the day).

….A decade or two from now, when an antibiotic resistant bacteria or new strain of bird flu is ravaging humanity, that generation will no longer be around to lead the scientific charge on humanity’s behalf. That’s why we constantly need a new stream of young people committing to health science careers. That seed corn is currently being consumed at an alarming rate, and if we don’t act immediately to rectify the situation we will suffer for many years to come from the loss of a generation of health researchers.

Because NIH grants typically last a long time—five to ten years or more—budget reductions have an oversized effect on new research proposals. When funding goes down thanks to austerity-obsessed politicians, existing grants have to keep getting funded, which means that virtually no new money opens up for new projects. And this is coming at the same time that the drug pipeline is slowing down, antibiotic-resistant superbugs are surging, and we’re still struggling to figure out how make use of the genomic revolution.

We are insane.

Link:

Chart of the Day: We Are Deliberately Destroying Our Medical Future

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