The report, “Ethics and Clinical Research” — sometimes called Beecher’s bombshell — appeared in the New England Journal of Medicine on June 16, 1966. Its author, Dr. Henry Knowles Beecher, an acclaimed professor of anaesthesia at Harvard Medical School and department chair at Massachusetts General Hospital, accused scientists at some of the nation’s top medical schools, hospitals, and other research institutions of unethical research that could have, and sometimes did, harm research subjects, many of whom had no knowledge they were even part of a study.

The solution to more ethical research, Beecher argued, “is the presence of a truly responsible investigator.” The NIH had other ideas. It created new rules for research that it funded. The rules explicitly required researchers to document that they had obtained informed consent from people taking part in clinical research. The rules also created panels for outside review of research protocols by boards that include lay people, ethicists, clergy, other clinicians — the institutional review boards (IRBs) that are today a mainstay of clinical research. Beecher would have despised this bureaucratic approach to improving research ethics.

Sean Parker, whose net worth the Bloomberg Billionaires Index puts at about $3 billion, started his institute with money from his nonprofit Parker Foundation. Zuckerberg and Chan, with a net worth of about $50 billion, are beginning with $3 billion from their Chan Zuckerberg Initiative, which unlike typical philanthropic outfits is a limited liability company. That gives the couple more flexibility; for example, they don’t have to give to charity every year and can make investments and political donations.

Parker, who started his institute with $250 million in seed money, said there’s no point in going down the well-trod roads. “The world is full of pretty stodgy foundations that generally do pretty safe things. I’d rather see what happens when you do something totally different that’s never been tried.” At the moment, there’s cautious enthusiasm about such donors, considering the status of federal funding. Most money for research has come from the National Institutes of Health, whose appropriations have been basically flat for 13 years. The trajectory isn’t expected to change.

Asthma is the leading chronic disease among children, but it hits some populations harder than others. According to the federal Centers for Disease Control and Prevention, black children are twice as likely to have asthma as white children. And black children are 10 times more likely than white kids to die of complications from asthma.

"Women present differently than men do for heart attacks," says Buchard. "So a whole generation of physicians were misclassifying and misdiagnosing women simply because women were not involved in the original clinical trials."

In 1993, Congress passed legislation requiring that publicly funded medical studies include more minorities. But a 2015 review of lung disease studies found only 5 percent of publicly funded research included patients of color.

The subpoena had come from the House of Representatives’ Select Investigative Panel On Infants’ Lives, led by Rep. Marsha Blackburn (R-Tenn.). Gu’s start-up research company, Ganogen, is one of more than 30 organizations being investigated by House Republicans over the use of fetal tissue from abortion clinics.

Gu obtains the organs he uses in his research from StemExpress, a company that accepts fetal tissue donations from abortion providers and supplies it to biomedical researchers. Republicans in Congress have been on a mission to outlaw the practice, which they describe as “selling baby body parts,” since an anti-abortion activist produced a series of heavily edited “sting videos” on Planned Parenthood working with StemExpress in 2015. Planned Parenthood says it sometimes donates, but does not sell, fetal tissue for medical research after an abortion at the request of the mother. The family planning provider is then reimbursed for the costs of transporting and preserving the tissue, which is explicitly allowed by federal law.

Gu has temporarily suspended his research due to a lack of funds and the toxic political environment. He hopes to be able to resume it when the smoke clears. In the meantime, he wants to shine a light on the ways in which Congress’ investigation is intimidating scientists like him into halting their potentially life-saving work.

“I no longer want to remain silent over these abuses directed toward me, toward other researchers, toward women and toward millions of patients,” he said.

"BioMed Central, a UK-based publishing house that’s responsible for distributing 277 peer-reviewed journals, has retracted 43 papers, having discovered that they had published several papers with fabricated peer reviews.

As Barbash reports for The Washington Post, the issue of fabricated peer reviewing can appear in the form of careless and lazy reviewing, friends reviewing work by friends, or outright fraud. "Last year, in one of the most publicised scandals, the Journal of Vibration and Control, in the field of acoustics, retracted 60 articles at one time due to what it called a 'peer review and citation ring' in which the reviews, mostly from scholars in Taiwan, were submitted by people using fake names," says Barbash.

Meanwhile, late last year a hoax paper authored by two Simpsons characters and 'Kim Jong Fun' proved that some journals will literally accept anything, while a separate journal was found to have accepted a paper entitled "Get me off your f*cking mailing list", calling it "excellent" science, no less. The system's far from broken, but we've got a lot of improving to do."

"For Masri, his smartphone has now become an essential tool for fieldwork [with Syrian refugees]. When he needs a second opinion, apps like Figure1 and those developed by Doctors Without Borders connect him with medical professionals across the world on a real-time basis. The downside is that Internet service and electricity aren't always reliable. Masri occasionally finds that Wi-Fi cuts out when he's halfway done uploading a photo, which is a constant source of stress and anxiety."

"The United States faces a shortage of as many as 90,000 physicians by 2025, including a critical need for specialists to treat an aging population that will increasingly live with chronic disease, the association that represents medical schools and teaching hospitals reported Tuesday. The average age for actively licensed physicians in 2014 is 52 years, compared with an average physician age of 51 years in 2012 and 50 years in 2010. In 2013, there were about 767,000 doctors practicing in the United States, according to the report."

* * *

"The lack of replacements for aging farmers is a real concern. The average age of U.S. farmers is 58.3 years, and over the next 25 years, more than one-fourth of all farmers are expected to retire, which would require an additional 700,000 to replace them. Between 2007 and 2012, the number increased by only 1,220, according to the National Young Farmers Coalition (NYFC)."

"A highly regarded service that vets new studies for clinicians finds — on average — only 3,000 of 50,000 new journal articles published each year are well-designed and relevant enough to inform patient care. That's 6 percent. More often than not, single studies contradict one another — such as the research on foods that cause or prevent cancer. The truth can be found somewhere in the totality of the research, but we report on every study in isolation underneath flip-flopping headlines. (Red wine will add years to your life one week, and kill you quicker the next.)"

"Disease is just one of the ways we ascribe meaning to suffering. That said, it is often useful to classify unpleasant sensations and try to ameliorate them. When health professionals choose to rope off medically unexplained symptoms from everything else, what is at issue is not the reality of those symptoms, but rather what they mean. Beliefs about the sensations of the internal world guide our interpretation, categorisation, and experience of them. We need to exchange existing metaphors for more pragmatic ones that integrate psychological processes, without so much health accorded to pleasantness and pathology to discomfort. Perhaps this new somatic symptom disorder is one step in that direction.

But, as the philosopher and psychologist William James observed, a pragmatic view recognises that the most important changes in a person's beliefs “leave most of his old order standing…so as to ever show a minimum of jolt, a maximum of continuity”. And so it is difficult to trade worn out metaphors for new ones that need time to wear in, and the fit of one's metaphorical illness might resist all but the lightest tailoring."

"Obama’s $4-trillion plan for fiscal year 2016 includes $146 billion for scientific research and development, a healthy 6% increase for a portfolio split roughly evenly between defence and civilian programmes. The proposal, which seeks to turn back years of fiscal austerity, is the opening salvo in what is likely to be a long war with the Republican-controlled Congress over government spending... For the first time in years, the US National Institutes of Health (NIH) was slated for a sizeable budget increase — to $31.3 billion, $1 billion more than it received in 2015."

"And despite the NIH’s efforts, the average age at which a researcher wins his or her first award has not declined. This may be partly because of broader demographic changes in the biomedical workforce. About 1 in 3 working scientists was over 50 in 2010, compared with 1 in 5 in 1993. This helps to explain why the average age of NIH principal investigators has risen. The age of first innovation itself might be increasing, too, according to analyses of patent filings and the age at which Nobel laureates win their prizes."

"The NIH budget shot steadily upward from 1998 to 2003. That spawned great jubilation in biomedicine and a gold-rush mentality. But it didn't last. Since 2004, the NIH budget has decreased by more than 20 percent. (That's not counting the hefty two-year bump the budget got from stimulus funds via the American Recovery and Reinvestment Act of 2009.)

In absolute terms, there is still a lot of money for biomedical research — the NIH budget is about $30 billion a year. But with the doubling and subsequent decline in funding, supply and demand are completely out of whack. The current system for allocating funding has made the United States the leader in biomedical research worldwide, says Dr. Harold Varmus, who was head of the NIH when the funding doubled; he now runs the National Cancer Institute. 'And while I don't think we've lost that [edge] yet, we do see a rising tide in lots of places.'"

"'A panel size of 2,000 to 2,500 patients is too many,' says Dr. Schimpff. That’s the number of patients primary care doctors typically are forced to carry—and that means seeing 24 or more patients a day, and often these patients have 10 or more medical problems. The end result is that the average face-to-face clinic visit lasts about 12 minutes."

"Information helps us learn. Information helps us make better decisions. Being able to get the right information helps us make the best decisions. The medical chart has become a source of information for insurance companies hoping to perform quick audits to minimize payments, for researchers hoping to capture data and perform studies, for patients interested in getting more information about their conditions, and for administrators hoping find new ways to cut costs.

With all of the new eyes looking at electronic health data, we must not forget that its primary purpose is to document useful information so that providers can provide high-quality care by having pertinent and correct information available. Finally, we must remember that each patient identification number represents a real human with his own beliefs, biases, struggles, and desires who is hard to represent by a few checkboxes or templates, especially if those templates aren't edited to reflect the truth."

"The Lancet has this month published an important collection of articles on waste in medical research. The collection has grown from an article by Iain Chalmers and Paul Glasziou in which they argued that 85% of expenditure on medical research ($240 billion in 2010) is wasted. In a very powerful talk at last year’s peer review congress John Ioannidis showed that almost none of thousands of research reports linking foods to conditions are correct and how around only 1% of thousands of studies linking genes with diseases are reporting linkages that are real."

"More than 750 lobbyists represent groups of health professionals in Washington, pushing back on any effort to limit their incomes. The biggest spenders on lobbying — $80 million annually by health professionals — closely align with the highest-paid specialties."

"Medicare’s valuation of physicians’ services is based on a complex algorithm that is intended to take into account the time and skill required to perform a medical task, with an adjustment made for a specialty’s malpractice rates. Many insurers follow Medicare’s lead, often paying anywhere from 80 percent to 200 percent of the Medicare fee. But 'time and skill' are easier to quantify for procedures than continuing patient management. And, experts say, Medicare has not reduced payments for many procedures that now take far less time than when they were invented, because of improvements in efficiency or technology."

"The British drug maker GlaxoSmithKline will no longer pay doctors to promote its products and will stop tying compensation of sales representatives to the number of prescriptions doctors write, its chief executive said Monday, effectively ending two common industry practices that critics have long assailed as troublesome conflicts of interest."

"As different medical specialties and physician groups interact less, physicians are less likely to see colleagues. Those they do see are likely to be much like themselves. This clustering of physicians decreases the frequency and diversity of physician-physician interactions. And this degradation of physician-physician interaction contributes to discontinuities in patient care and decreases the rate at which physicians gain new insights and produce new innovations."

"This year, about 96 percent of the nation’s 29,171 residency slots were filled, according the National Residency Matching Program (NRMP) Databook. This was the largest match in NRMP history. On average, program directors receive about 2,000 applications, letters of recommendations, medical school transcripts and other documents through the Electronic Residency Application Service. But because most programs have only 15 or 20 slots to fill, directors must turn away far more hopefuls than they accept."

"It is a paradoxical thing that we are both at a time of remarkable and almost unprecedented scientific opportunity, and we're also at a time in the United States of unprecedented threats to the momentum of scientific progress," said Francis Collins, director of the National Institutes of Health.

Sequestration, which went into effect March 1, 2013 after Congress failed to reach a budget compromise, cuts $85 billion across government departments, agencies and programs.

The NIH, which will lose $1.6 billion of its $30-billion budget through the sequester, is the world's largest supporter of biomedical research, funding $2 billion in programs at the University of California system alone.

Under sequestration, agencies that fund research and development would see their budgets cut 5.1 to 7.3 percent in 2013 and remain stagnant through 2021.

No comments: