Welcome to the Nexus of Ethics, Psychology, Morality, Philosophy and Health Care

Welcome to the nexus of ethics, psychology, morality, technology, health care, and philosophy
Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Wednesday, February 9, 2022

How FDA Failures Contributed to the Opioid Crisis

Andrew Kolodny, MD
AMA J Ethics. 2020;22(8):E743-750. 
doi: 10.1001/amajethics.2020.743.

Abstract

Over the past 25 years, pharmaceutical companies deceptively promoted opioid use in ways that were often neither safe nor effective, contributing to unprecedented increases in prescribing, opioid use disorder, and deaths by overdose. This article explores regulatory mistakes made by the US Food and Drug Administration (FDA) in approving and labeling new analgesics. By understanding and correcting these mistakes, future public health crises caused by improper pharmaceutical marketing might be prevented.

Introduction

In the United States, opioid use disorder (OUD) and opioid overdose were once rare. But over the past 25 years, the number of Americans suffering from OUD increased exponentially and in parallel with an unprecedented increase in opioid prescribing. Today, OUD is common, especially in patients with chronic pain treated with opioid analgesics, and opioid overdose is the leading cause of accidental death.

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Oversight Recommendations

While fewer clinicians are initiating long-term opioids, overprescribing is still a problem. According to a recently published report, more than 2.9 million people initiated opioid use in December 2017. The FDA’s continued approval of new opioids exacerbates this problem. Each time a branded opioid hits the market, the company, eager for return on its investment, is given an incentive and, in essence, a license to promote aggressive prescribing. The FDA’s continued approval of new opioids pits the financial interests of drug companies against city, state, and federal efforts to discourage initiation of long-term opioids.

To finally end the opioid crisis, the FDA must enforce the Food, Drug, and Cosmetic Act, and it must act on recommendations from the NAS for an overhaul of its opioid approval and removal policies. The broad indication on opioid labels must be narrowed, and an explicit warning against long-term use and high-dose prescribing should be added. The label should reinforce, rather than contradict, guidance from the CDC, the Department of Veterans Affairs, the Agency for Healthcare Research and Quality, and other public health agencies that are calling for more cautious prescribing.

Friday, August 20, 2021

Would I Give Aducanumab to My Mother?

Dena S. Davis
The Hastings Center
Originally published 11 June 21

Here is an excerpt:

First, it is not at all clear that the drug works, in terms of affecting cognition and slowing decline. As Jason Karlawish explains in an incisive piece in STAT, crucial scientific steps were missed, and the current data are inconclusive and contradictory. 

Side effects include possible brain swelling and bleeds (which appear to be severe in about 6% of patients), headache, falls, diarrhea, and what Biogen describes as “confusion/delirium/altered mental status/disorientation.”  Wait a minute!  I thought the reason to take this drug was that one already had altered mental status and confusion.

Before someone is even considered eligible for aducanumab, they must take a PET scan to ascertain that they have elevated levels of amyloid and then an MRI to make sure they don’t already have brain swelling. MRIs have to be repeated regularly while people are on the drug. I know perfectly competent adults who are freaked out by MRI’s.  How do you explain this to someone with dementia?  Or do you sedate them, thus adding to the risk? Furthermore, the drug itself is not a pill, but a monthly infusion. 

Put that all together, and it just doesn’t add up. How would my mother’s life change for the better? There is little evidence of the drug’s efficacy. Meanwhile, her peaceful life in her rural home with her dedicated caregiver would now be punctuated by trips to the hospital for MRI’s, and monthly struggles to start infusions in her 90-year-old body, with its tiny veins and paper-thin skin. Aducanumab is apparently best suited to people in the early stages of Alzheimer’s, but even in the earliest stage my mother refused to accept that she had a problem. I cannot imagine successfully explaining that we were taking these measures in the faint hope of combatting a problem she insisted she didn’t have. And in the absence of an explanation she could understand, surely the frequent hospital trips would feel to her like unpleasant, even scary, invasions.


Monday, September 21, 2020

The ethics of pausing a vaccine trial in the midst of a pandemic

Patrick Skerrett
statnews.com
Originally posted 11 Sept 20

Here is an excerpt:

Is the process for clinical trials of vaccines different from the process for drug or device trials?

Mostly no. The principles, design, and basic structure of a vaccine trial are more or less the same as for a trial for a new medication. The research ethics considerations are also similar.

The big difference between the two is that the participants in a preventive vaccine trial are, by and large, healthy people — or at least they are people who don’t have the illness for which the agent being tested might be effective. That significantly heightens the risk-benefit calculus for the participants.

Of course, some people in a Covid-19 vaccine trial could personally benefit if they live in communities with a lot of Covid-19. But even then, they might never get it. That’s very different than a trial in which individuals have a condition, say melanoma or malignant hypertension, and they are taking part in a trial of a therapy that could improve or even cure their condition.

Does that affect when a company might stop a trial?

In every clinical trial, the data and safety monitoring board takes routine and prescheduled looks at the accumulated data. They are checking mainly for two things: signals of harm and evidence of effectiveness.

These boards will recommend stopping a trial if they see a signal of concern or harm. They may do the same thing if they see solid evidence that people in the active arm of the trial are doing far better than those in the control arm.

In both cases, the action is taken on behalf of those participating in the trial. But it is also taken to advance the interests of people who would get this intervention if it was to be made publicly available.

The current situation with AstraZeneca involves a signal of concern. The company’s first obligation is to the participants in the trial. It cannot ethically proceed with the trial if there is reason for concern, even based on the experience of one participant.

Tuesday, September 8, 2020

Pharma drew a line in the sand over Covid-19 vaccine readiness, because someone had to

Ed Silverman
statnews.com
Originally posted 7 Sept 20

Here is an excerpt:

The vaccine makers that are signing this pledge — Pfizer, Merck, AstraZeneca, Sanofi, GlaxoSmithKline, BioNTech, Johnson & Johnson, Moderna, and Novavax — are rushing to complete clinical trials. But only Pfizer has indicated it may have late-stage results in October, and that’s not a given.

Yet any move by the FDA to green light a Covid-19 vaccine without late-stage results will be interpreted as an effort to boost Trump — and rightly so.

Consider Trump’s erratic and selfish remarks. He recently accused the FDA of slowing the vaccine approval process and being part of a “deep state.” No wonder there is concern he may lean on Hahn to authorize emergency use prematurely. For his part, Hahn has insisted he won’t buckle to political pressure, but he also said emergency use may be authorized based on preliminary data.

“It’s unprecedented in my experience that industry would do something like this,” said Ira Loss of Washington Analysis, who tracks pharmaceutical regulatory and legislative matters for investors. “But we’ve experienced unprecedented events since the beginning of Covid-19, starting with the FDA, where the commissioner has proven to be malleable, to be kind, at the foot of the president.”

Remember, we’ve seen this movie before.

Amid criticism of his handling of the pandemic, Trump touted hydroxychloroquine, a decades-old malaria tablet, as a salve and the FDA authorized emergency use. Two weeks ago, he touted convalescent blood plasma as a medical breakthrough, but evidence of its effectiveness against the coronavirus is inconclusive. And Hahn initially overstated study results.

Most Americans seem to be catching on. A STAT-Harris poll released last week found that 78% of the public believes the vaccine approval process is driven by politics, not science. This goes for a majority of Democrats and Republicans.

The info is here.

Wednesday, September 2, 2020

Poll: Most Americans believe the Covid-19 vaccine approval process is driven by politics, not science

Ed Silverman
statnews.com
Originally published 31 August 20

Seventy-eight percent of Americans worry the Covid-19 vaccine approval process is being driven more by politics than science, according to a new survey from STAT and the Harris Poll, a reflection of concern that the Trump administration may give the green light to a vaccine prematurely.

The response was largely bipartisan, with 72% of Republicans and 82% of Democrats expressing such worries, according to the poll, which was conducted last week and surveyed 2,067 American adults.

The sentiment underscores rising speculation that President Trump may pressure the Food and Drug Administration to approve or authorize emergency use of at least one Covid-19 vaccine prior to the Nov. 3 election, but before testing has been fully completed.

Concerns intensified in recent days after Trump suggested in a tweet that the FDA is part of a “deep state” conspiracy to sabotage his reelection bid. In a speech Thursday night at the Republican National Convention, he pledged that the administration “will produce a vaccine before the end of the year, or maybe even sooner.”

The info is here.

Please see top line: 80% of Americans surveyed worry that approving vaccine too quickly would worry about safety.  The implication is that fewer people would choose the vaccine if safety is an issue.

Thursday, May 21, 2020

Discussing the ethics of hydroxychloroquine prescriptions for COVID-19 prevention

Sharon Yoo
KARE11.com
Originally published 19 May 20

President Donald Trump said on Monday that he's been taking hydroxychloroquine to protect himself against the coronavirus. It is a drug typically used to treat malaria and lupus.

The Federal Drug Administration issued warnings that the drug should only be used in clinical trials or for patients at a hospital under the Emergency Use Authorization.

"Yeah, a White House doctor, didn't recommend—I asked him what do you think—and he said well, if you'd like it and I said yeah, I'd like it, I'd like to take it," President Trump said, when a reporter asked him if a White House doctor recommended that he take hydroxychloroquine on Monday.

In a statement, the President's physician, Dr. Sean Conley said after discussions, they've concluded the potential benefit from treatment outweighed the relative risks. All this, despite the FDA warnings.

University of Minnesota bioethics professor Joel Wu said this is problematic.

"It's ethically problematic if the President is being treated for COVID specifically by hydroxychloroquine because our understanding based on the current evidence is not safe or effective in treating or preventing COVID," Wu said.

The info is here.

Thursday, April 9, 2020

Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior

FDA Press Release
Posted March 5, 2020

Here is an excerpt:

After careful consideration, the U.S. Food and Drug Administration today published a final rule to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling.

“Since ESDs were first marketed more than 20 years ago, we have gained a better understanding of the danger these devices present to public health,” said William Maisel, M.D., M.P.H., director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health. “Through advancements in medical science, there are now more treatment options available to reduce or stop self-injurious or aggressive behavior, thus avoiding the substantial risk ESDs present.”

ESDs administer electrical shocks through electrodes attached to the skin of individuals to immediately interrupt self-injurious or aggressive behavior or attempt to condition the individuals to stop engaging in such behavior. Evidence indicates a number of significant psychological and physical risks are associated with the use of these devices, including worsening of underlying symptoms, depression, anxiety, posttraumatic stress disorder, pain, burns and tissue damage. In addition, many people who are exposed to these devices have intellectual or developmental disabilities that make it difficult to communicate their pain. Evidence of the device’s effectiveness is weak and evidence supporting the benefit-risk profiles of alternatives is strong. As the risks presented by ESDs meet the agency’s definition of unreasonable and substantial and cannot be corrected or eliminated through new or updated labeling, banning the product is necessary to protect public health.

The act of banning a device is rare and the circumstances under which the agency can take this action is stringent, but the FDA has the authority to take this action when necessary to protect the health of the public. The FDA has only banned two other medical devices since gaining the authority to do so.

This final rule issued today follows a 2016 proposed rule to ban ESDs from the marketplace and takes effect 30 days after publication in the Federal Register. The FDA understands that a gradual transition period may be needed for a subgroup of individuals currently exposed to these devices, to allow time for them to transition to another treatment, so the agency is establishing two compliance dates. For devices in use on specific individuals as of the date of publication and subject to a physician-directed transition plan, compliance is required 180 days after publication of the final rule in the Federal Register. For all other devices, compliance is required 30 days after publication of the final rule in the Federal Register.

The FDA received more than 1,500 comments on the proposed rule, as well as approximately 300 comments submitted to the April 2014 FDA advisory panel meetingExternal Link Disclaimerdocket, which the FDA has associated with this rulemaking action. Comments were received from a variety of stakeholders, including parents of individuals with intellectual and developmental disabilities, state agencies and their sister public-private organizations, the affected manufacturer and residential facility, some of the facility’s employees, and parents of individual residents. State and federal legislators also expressed interest, as did state and national advocacy groups. The overwhelming majority of comments supported this ban.

The proposed rule is here.

Wednesday, February 5, 2020

A Reality Check On Artificial Intelligence: Are Health Care Claims Overblown?

Liz Szabo
Kaiser Health News
Originally published 30 Dec 19

Here is an excerpt:

“Almost none of the [AI] stuff marketed to patients really works,” said Dr. Ezekiel Emanuel, professor of medical ethics and health policy in the Perelman School of Medicine at the University of Pennsylvania.

The FDA has long focused its attention on devices that pose the greatest threat to patients. And consumer advocates acknowledge that some devices ― such as ones that help people count their daily steps ― need less scrutiny than ones that diagnose or treat disease.

Some software developers don’t bother to apply for FDA clearance or authorization, even when legally required, according to a 2018 study in Annals of Internal Medicine.

Industry analysts say that AI developers have little interest in conducting expensive and time-consuming trials. “It’s not the main concern of these firms to submit themselves to rigorous evaluation that would be published in a peer-reviewed journal,” said Joachim Roski, a principal at Booz Allen Hamilton, a technology consulting firm, and co-author of the National Academy’s report. “That’s not how the U.S. economy works.”

But Oren Etzioni, chief executive officer at the Allen Institute for AI in Seattle, said AI developers have a financial incentive to make sure their medical products are safe.

The info is here.

Friday, October 18, 2019

The Koch-backed right-to-try law has been a bust, but still threatens our health

Michael Hiltzik
The Los Angeles Times
Originally posted September 17, 2019

The federal right-to-try law, signed by President Trump in May 2018 as a sop to right-wing interests, including the Koch brothers network, always was a cruel sham perpetrated on sufferers of intractably fatal diseases.

As we’ve reported, the law was promoted as a compassionate path to experimental treatments for those patients — but in fact was a cynical ploy aimed at emasculating the Food and Drug Administration in a way that would undermine public health and harm all patients.

Now that a year has passed since the law’s enactment, the assessments of how it has functioned are beginning to flow in. As NYU bioethicist Arthur Caplan observed to Ed Silverman’s Pharmalot blog, “the right to try remains a bust.”

His judgment is seconded by the veteran pseudoscience debunker David Gorski, who writes: “Right-to-try has been a spectacular failure thus far at getting terminally ill patients access to experimental drugs.”

That should come as no surprise, Gorski adds, because “right-to-try was never about helping terminally ill patients. ... It was always about ideology more than anything else. It was always about weakening the FDA’s ability to regulate drug approval.”

The info is here.

Saturday, July 6, 2019

Congress weighs dropping ban on altering the DNA of human embryos used for pregnancies

Embryonic cell divisionSharon Begley and Andrew Joseph
www.statnews.xom
Originally posted June 4, 2019

A congressional committee is expected to vote on Tuesday to drop a ban on altering the genomes of human embryos intended for pregnancies, which could open the door to creating babies with genetic material from three people or with genomes that have been modified in a way that would be inherited by their descendants, as China’s “CRISPR babies” were.

The prohibition on modifying the DNA of embryos for reproduction (as opposed to doing so in basic research that stops short of pregnancies) has been attached to bills that fund the Food and Drug Administration since December 2015. But last month, a House appropriations subcommittee approved a version of an FDA spending bill without the amendment, or rider — amid worldwide condemnation of the CRISPR babies experiment last year and calls by leading scientists for a global moratorium on creating gene-edited babies.

“People don’t appreciate that this is the only piece of legislation in the United States that stands between us and genetically engineered children,” said science historian J. Benjamin Hurlbut of Arizona State University, who supports a “global observatory” to track uses of CRISPR, the powerful genome-editing technology.

The info is here.

Monday, July 2, 2018

What Does an Infamous Biohacker’s Death Mean for the Future of DIY Science?

Kristen Brown
The Atlantic
Originally posted May 5, 2018

Here are two excerpts:

At just 28, Traywick was among the most infamous figures in the world of biohacking—the grandiose CEO of a tiny company called Ascendance Biomedical whose goal was to develop and test new gene therapies without the expense and rigor of clinical trials or the oversight of the FDA. Traywick wanted to cure cancer, herpes, HIV, and even aging, and he wanted to do it without having to deal with the rules and safety precautions of regulators and industry standards.

“There are breakthroughs in the world that we can actually bring to market in a way that wouldn’t require us to butt up against the FDA’s walls, but instead walk around them,” Traywick told me the first time I met him in person, during a biotech conference in San Francisco last January.

To “walk around” regulators, Ascendance and other biohackers typically rely on testing products on themselves. Self-experimentation, although strongly discouraged by agencies like the FDA, makes it difficult for regulators to intervene. The rules that govern drug development simply aren’t written to oversee what an individual might do to themselves.

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The biggest shame, said Zayner, is that we’ll never get the chance to see how Traywick might have matured once he’d been in the biohacking sphere a little longer.

Whatever their opinion of Traywick, everyone who knew him agreed that he was motivated by an extreme desire to make drugs more widely available for those who need them.

The information is here.

Wednesday, February 21, 2018

The Federal Right to Try Act of 2017—A Wrong Turn for Access to Investigational Drugs and the Path Forward

Alison Bateman-House and Christopher T. Robertson
JAMA Intern Med. Published online January 22, 2018.

In 2017, President Trump said that “one thing that’s always disturbed”1 him is that the US Food and Drug Administration (FDA) denies access to experimental drugs even “for a patient who’s terminal…[who] is not going to live more than four weeks [anyway.]”  Fueled by emotionally charged anecdotes recirculated by libertarian political activists, 38 states have passed Right to Try laws. In 2017, the US Senate approved a bill that would create a national law (Box). As of December 2017, the US House of Representatives was considering the bill.

The article is here.

Wednesday, January 17, 2018

‘I want to help humans genetically modify themselves’

Tom Ireland
The Guardian
Originally posted December 24, 2017

Josiah Zayner, 36, recently made headlines by becoming the first person to use the revolutionary gene-editing tool Crispr to try to change their own genes. Part way through a talk on genetic engineering, Zayner pulled out a syringe apparently containing DNA and other chemicals designed to trigger a genetic change in his cells associated with dramatically increased muscle mass. He injected the DIY gene therapy into his left arm, live-streaming the procedure on the internet.

The former Nasa biochemist, based in California, has become a leading figure in the growing “biohacker” movement, which involves loose collectives of scientists, engineers, artists, designers, and activists experimenting with biotechnology outside of conventional institutions and laboratories.

Despite warnings from the US Food and Drug Administration (FDA) that selling gene therapy products without regulatory approval is illegal, Zayner sells kits that allow anyone to get started with basic genetic engineering techniques, and has published a free guide for others who want to take it further and experiment on themselves.

The article is here.

Tuesday, January 9, 2018

Drug Companies’ Liability for the Opioid Epidemic

Rebecca L. Haffajee and Michelle M. Mello
N Engl J Med 2017; 377:2301-2305
December 14, 2017
DOI: 10.1056/NEJMp1710756

Here is an excerpt:

Opioid products, they alleged, were defectively designed because companies failed to include safety mechanisms, such as an antagonist agent or tamper-resistant formulation. Manufacturers also purportedly failed to adequately warn about addiction risks on drug packaging and in promotional activities. Some claims alleged that opioid manufacturers deliberately withheld information about their products’ dangers, misrepresenting them as safer than alternatives.

These suits faced formidable barriers that persist today. As with other prescription drugs, persuading a jury that an opioid is defectively designed if the Food and Drug Administration approved it is challenging. Furthermore, in most states, a drug manufacturer’s duty to warn about risks is limited to issuing an adequate warning to prescribers, who are responsible for communicating with patients. Finally, juries may resist laying legal responsibility at the manufacturer’s feet when the prescriber’s decisions and the patient’s behavior contributed to the harm. Some individuals do not take opioids as prescribed or purchase them illegally. Companies may argue that such conduct precludes holding manufacturers liable, or at least should reduce damages awards.

One procedural strategy adopted in opioid litigation that can help overcome defenses based on users’ conduct is the class action suit, brought by a large group of similarly situated individuals. In such suits, the causal relationship between the companies’ business practices and the harm is assessed at the group level, with the focus on statistical associations between product use and injury. The use of class actions was instrumental in overcoming tobacco companies’ defenses based on smokers’ conduct. But early attempts to bring class actions against opioid manufacturers encountered procedural barriers. Because of different factual circumstances surrounding individuals’ opioid use and clinical conditions, judges often deemed proposed class members to lack sufficiently common claims.

The article is here.

Friday, October 6, 2017

Lawsuit Over a Suicide Points to a Risk of Antidepressants

Roni Caryn Rabin
The New York Times
Originally published September 11, 2017

Here is an excerpt:

The case is a rare instance in which a lawsuit over a suicide involving antidepressants actually went to trial; many such cases are either dismissed or settled out of court, said Brent Wisner, of the law firm Baum Hedlund Aristei Goldman, which represented Ms. Dolin.

The verdict is also unusual because Glaxo, which has asked the court to overturn the verdict or to grant a new trial, no longer sells Paxil in the United States and did not manufacture the generic form of the medication Mr. Dolin was taking. The company argues that it should not be held liable for a pill it did not make.

Concerns about safety have long dogged antidepressants, though many doctors and patients consider the medications lifesavers.

Ever since they were linked to an increase in suicidal behaviors in young people more than a decade ago, all antidepressants, including Paxil, have carried a “black box” warning label, reviewed and approved by the Food and Drug Administration, saying that they increase the risk of suicidal thinking and behavior in children, teens and young adults under age 25.

The warning labels also stipulate that the suicide risk has not been seen in short-term studies in anyone over age 24, but urges close monitoring of all patients initiating drug treatment.

The article is here.

Wednesday, September 13, 2017

Peter Thiel sponsors offshore testing of herpes vaccine, sidestepping U.S. safety rules

Marisa Taylor
Kaiser News
Originally posted August 28, 2017

Here is an excerpt:

“What they’re doing is patently unethical,” said Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division. “There’s a reason why researchers rely on these protections. People can die.”

The risks are real. Experimental trials with live viruses could lead to infection if not handled properly or produce side effects in those already infected. Genital herpes is caused by two viruses that can trigger outbreaks of painful sores. Many patients have no symptoms, though a small number suffer greatly. The virus is primarily spread through sexual contact, but also can be released through skin.

The push behind the vaccine is as much political as medical. President Trump has vowed to speed up the FDA’s approval of some medicines. FDA Commissioner Scott Gottlieb, who had deep financial ties to the pharmaceutical industry, slammed the FDA before his confirmation for over-prioritizing consumer protection to the detriment of medical innovations.

“This is a test case,” said Bartley Madden, a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute, who is another investor in the vaccine. “The FDA is standing in the way, and Americans are going to hear about this and demand action.”

American researchers are increasingly going offshore to developing countries to conduct clinical trials, citing rising domestic costs. But in order to approve the drug for the U.S. market, the FDA requires that clinical trials involving human participants be reviewed and approved by an IRB or an international equivalent. The IRB can reject research based on safety concerns.

The article is here.

Wednesday, March 15, 2017

Researchers Are Divided as FDA Moves to Regulate Gene Editing

Paul Basken
The Chronicle of Higher Education
Originally published February 22, 2017

As U.S. regulators threaten broad new limits on the use of gene-editing technology, a Utah State University researcher now engineering goats to produce spider silk in their milk isn’t particularly worried.

"They’re just trying to modernize" rules to keep up with technology, the Utah professor, Randolph V. Lewis, said of the changes proposed by the U.S. Food and Drug Administration.

But over in Minnesota, a researcher working to create cows without horns — as a way of keeping the animals safe from one another — has a far different take.

"It’s a huge overreach" by the FDA that could stifle innovation, said Scott C. Fahrenkrug, an adjunct professor of functional genomics at the University of Minnesota at Twin Cities.

The FDA is responsible for ensuring the safety of food and drugs sold to Americans, and for years it has defined that oversight to require its approval when genes are added to animals whose products might be consumed. The change it proposed last month would expand that authority to cover new technologies such as CRISPR that enable gene-specific editing, potentially enabling changes not found in any known species.

To supporters, the FDA is simply trying to keep up with the science. To detractors, it’s a reach for authority so broad as to go beyond any reasonable definition of the FDA’s mandate.

The article is here.

Wednesday, August 31, 2016

Adding ages: The fight to cheat death is hotting up

The Economist
Originally published August 13, 2016

Here is an excerpt:

Scientists at the Institute for Ageing Research at the Albert Einstein College of Medicine, in New York, want to mount a trial of metformin in elderly subjects to see whether it delays various maladies (and also death). If that turns out to be the case, it will go a long way to showing that there is a generalised ageing process that can be modulated with drugs. Nir Barzilai, one of the researchers involved, says an important reason to do the trial is to have an indication against which next-generation ageing drugs can be assessed by regulators.

This sort of interest seems to be triggering a change of tone at America’s Food and Drug Administration over whether it might approve an anti-ageing drug. The regulator is thinking about when a broad, and so far unprecedented, claim of anti-ageing might be considered to be supported by the evidence; it is “looking forward to seeing this area of science evolve”. In the dry language of a government agency these are encouraging words.

If an unregulated diet can do the trick, why does the world need drugs? Three reasons. One is that taking a few pills a day will be easier for most than subsisting on low-calorie muffins and salad. A second is that companies can make money making pills and will compete to create them. A third is that pills may work better than diets. Dr Barzilai, who is in the pill camp, points out that CR works less well in primates than other mammals, and that people with low body-mass indices, a natural condition for those restricting their calories, are in general more likely to die. Those who do well on CR, he says, are likely to be a subset benefiting from the right genetic make-up. His hope is that a range of targeted therapies might allow everyone to get the benefits.

The article is here.

Wednesday, July 20, 2016

An NYU Study Gone Wrong, and a Top Researcher Dismissed

By Benedict Carey
The New York Times
Originally posted June 27, 2016

New York University’s medical school has quietly shut down eight studies at its prominent psychiatric research center and parted ways with a top researcher after discovering a series of violations in a study of an experimental, mind-altering drug.

A subsequent federal investigation found lax oversight of study participants, most of whom had serious mental issues. The Food and Drug Administration investigators also found that records had been falsified and researchers had failed to keep accurate case histories.

In one of the shuttered studies, people with a diagnosis of post-traumatic stress caused by childhood abuse took a relatively untested drug intended to mimic the effects of marijuana, to see if it relieved symptoms.

The article is here.

Thursday, July 7, 2016

Secrets and lies: Faked data and lack of transparency plague global drug manufacturing

By Kelly Crowe
CBC News 
Originally posted: June 10, 2016

Here is an excerpt:

In another case, when the FDA responded to complaints from U.S. manufacturers about impurities in raw ingredients from a Chinese company and asked to see the data, inspectors discovered it had been deleted and the audit trail disabled.

Two companies on Health Canada's watch list have been caught falsifying the source of their active pharmaceutical ingredient. Both claimed to have made the raw material, but actually purchased it from somewhere else.

There's tragic proof that data integrity matters. In 2008, 19 people in the U.S. died and hundreds more were sickened by a contaminated blood thinner made from a raw material the FDA believes had been tampered with at its source in China.

The article is here.