The U.S. Food and Drug Administrations grants Johnson & Johnson’s (NYSE:JNJ)
Janssen Pharmaceutical unit a breakthrough therapy designation for
niraparib, an orally administered PARP inhibitor for the treatment of
patients with a certain type of prostate cancer and who have already
been treated with taxane chemotherapy and androgen receptor-targeted
therapy.
JNJ gains 1.0% in after-hours trading.
The poly ADP-ribose polymerase inhibitor is being
studied to treat patients with BRCA1/2 gene-mutated metastatic
castration-resistant prostate cancer. BRCA1/2 mutations are the most
common DNA-repair gene defects (DRD) in patients with mCRPC.
The designation is based on data from the Galahad
study, a Phase 2, multicenter, open-label clinical trial evaluating the
efficacy and safety of niraparib in the treatment of adult patients with
mCRPC and DRD who had received treatment with next-generation
androgen-receptor targeting therapies and docetaxel.
Put down the T-bone and slowly back away from that side order of ribs.
Nutritionists across the country are hitting back hard after a new collection of studies alleged that red meat and processed meats — including steak, ribs, bacon and salami — are fine for your health after all.
‘They ignored major parts of the available evidence.’
“Totally bizarre,” Harvard University professor Walter Willett told
MarketWatch. “It really displays ignorance. They ignored major parts of
the available evidence.”
He was speaking after the Annals of Internal Medicine, a publication
of the American College of Physicians, this week published a collection
of five studies that contradicted decades of growing consensus about the
health risks of red meat, including pork, and processed meats.
The studies didn’t actually say that red meat was good for you — they
just argued that the evidence they were bad for you was weak.
It concluded: “Low- to very-low-certainty evidence suggests that
diets restricted in red meat may have little or no effect on major
cardiometabolic outcomes and cancer mortality and incidence.”
But Willett said it made no sense to include red meat in good health
recommendations. “People [also] like to smoke,” he said. “They like to
drink sugared soft drinks, they like to have unsafe sex.”
Willett is professor of nutrition and epidemiology at Harvard’s T.H.
Chan School of Public Health. He’s chaired Harvard’s department of
nutrition for more than two decades and has published 1,700 academic
articles in the field.
He said avoiding red meat can slash the risks of diabetes and the
risk of dying young. A drug that did as much for your health, he said,
“would be a blockbuster. It would make tens of billions of dollars.”
McDonald’s MCD, +1.82% and Burger King QSR, +1.09% have recently introduced alternative options to beef. McDonald’s has a burger using Beyond Meat BYND, +1.49%, while Burger King has the Impossible Burger.
The Physicians Committee for Responsible Medicine, a nonprofit
medical advocacy group, on Tuesday filed a petition with the Federal
Trade Commission to rebut many of the claims made in the study. Neal
Barnard, the PRCM president, slammed the study’s authors for “misrepresentations,” “an inaccurate statement of the findings,” and “a major disservice to public health.”
Gordon Guyatt, professor of medicine at McMaster University in Canada
and one of the study’s authors, said the reaction “has reached levels I
would call hysteria.” He compared the nutrition establishment to the
Hans Christian Anderson tale, the Emperor’s New Clothes. “If you’re the
emperor, and somebody points out that you haven’t any clothes, this is
not going to be a very appealing situation,” he added. “It’s very
threatening, and people are defending their territory.”
‘It’s a form of patriarchy if we just tell people they should eliminate or reduce their meat consumption.’
Bradley Johnston, one of the study’s authors, an associate professor
of community health and epidemiology at Dalhousie University in Halifax,
Nova Scotia, told USA Today:
“It’s a form of patriarchy if we just tell people they should eliminate
or reduce their meat consumption. We don’t believe that there should be
broad public health recommendations, almost like scare tactics, for the
population as a whole.”
“Based on these reviews, we cannot say with any certainty that
reducing red meat or processed meat will prevent cancer, diabetes or
heart disease,” he added.
The American Heart Association, the American Cancer Society, and others also joined the backlash. The American College of Cardiology said it was “alarmed
by the reckless dietary recommendations” In 2015, the International
Agency for Research on Cancer’s Monograph panel, which is part of the
World Health Organization, voted on the issue and concluded that red
meat was “probably carcinogenic to humans.”
In response to that landmark decision, the North American Meat
Institute, a trade group for the industry, said that vote classifying
red and processed meat as cancer hazards “defies both common sense and numerous studies
showing no correlation between meat and cancer and many more studies
showing the many health benefits of balanced diets that include meat.”
The battle between the two sides of this debate, as this explainer at news site Vox shows,
involves technical disputes about how to construct scientific studies
in the real world, and which ones are more reliable, and why. The
limitation of all these studies is that they’re all flawed.
It’s not possible to control for all variables, unless the
participants were confined to a laboratory for years, if not decades.
That’s why researchers frequently caution readers that their conclusions
suggest correlation rather than causation.
All such studies naturally have theoretical flaws, says Jane
Uzcategui, professor of nutrition and food studies at Syracuse
Universities. But the observational studies about the risks of red meat
are so many, and so big, that we should give them a lot of weight, she
adds.
“The fact that we’ll never have any better evidence does not make it good evidence,” adds Guyatt.
All findings that challenge a consensus generate a backlash. The
latest study is the work of 14 researchers from seven countries.
The researchers aren’t without allies. Stanford University medical
professor John Iannodis told Vox’s Julia Belluz that the latest study
was “very rigorous and unbiased.”
He added, “These papers provide a nice counterbalance to the current
norm in nutritional epidemiology where scientists with strong advocacy
tend to overstate their findings and ask for major public health
overhauls even though the evidence is weak.” https://www.marketwatch.com/story/nutritionists-see-red-over-study-downplaying-the-health-risks-of-red-meat-2019-10-02
A landmark ruling Wednesday paved the way for a supervised injection
site in Philadelphia. While advocates won this battle, opponents say the
war isn’t over.
More than 1,100 people died from overdoses in Philadelphia last year. Opioids were involved in the vast majority of them.
The city says offering a space for those who suffer from addiction to
use will save lives. But the federal government and many neighbors do
not want it.
Had the judge ruled in favor of the federal government, supervised
injection sites would have been dead in the water. But plans to open one
in Philadelphia are now moving forward.
Philadelphia has one of the highest overdose rates of any major city
in the country, and Kensington is ground zero for the opioid epidemic.
“It’s a mess,” Bernadette Sterling said.
Sterling has lived near Kensington Avenue and East Cambria Street for
more than four decades. She says not a single day passes where she’s
not reminded of the crisis.
“It’s nothing. It’s like walking zombies,” she said.
Even seeing the problem firsthand, Sterling says she’s not in favor
of so-called safe injection sites, where people can use heroin while
medical staff stand by with the overdose reversal drug Naloxone.
“I don’t support any of this,” Sterling said.
But those supervised injection sites could soon open up.
A federal judge ruled Wednesday that the facilities do not violate federal law.
“It is the first of its kind in the United States,” Linda Dale Hoffa, a law partner at Dilworth Paxon LLP, said.
Hoffa, a former federal prosecutor, explains the government argued
Philadelphia’s plans violated a part of the U.S. Controlled Substances
Act, which is also known as the Crackhouse Law.
“The United States Attorney says operating a safe injection site
where they will facilitate the use of illegal drugs is the same as
operating a crackhouse,” Hoffa said.
But Judge Gerald McHugh says the intent of the 1986 bill is very different than what is being proposed with Philly’s plan.
“The judge said there is a different purpose going on here, and the purpose of the safe injection site is to help,” Hoffa said.
“I can see both sides,” a community activist named Bernard said.
Bernard volunteers his time picking up used needles. He knows
neighbors are concerned, but he believes the injection sites would
provide immediate access to treatment and a way to help slow such a
devastating problem.
“It’s got to go in somebody’s neighborhood,” Bernard said. “It’ll be in Kensington somewhere.”
U.S. Attorney William McSwain, an appointee of Republican President
Donald Trump, had gone to court in Philadelphia to try to block the
plan, calling the goal “laudable” but supporters misguided.
“Today’s opinion is merely the first step in a much longer legal
process that will play out. This case is obviously far from over. We
look forward to continuing to litigate it, and we are very confident in
our legal position,” McSwain said.
Based on that statement, it’s safe to say the decision will likely be
appealed and therefore, there is no timeline on when a supervised
injection site could open.
Amicus Therapeutics (FOLD+6.5%) rebounds on heavy volume a day after dropping to fresh two-year lows before ultimately netting a gain for the day.
FOLD yesterday reported additional “positive” results
from a Phase 1/2 clinical study investigating AT-GAA in adult patients
with Pompe disease; the Food and Drug Administration previously granted
Breakthrough Therapy Designation to AT-GAA for the treatment of late
onset Pompe disease based on clinical efficacy results the study.
The company says it will present the results tomorrow at the International Annual Congress of the World Muscle Society.
Japan’s “overly restrictive” drug pricing policies risk diverting
foreign direct investment to China and other markets, the chief
executive of Bristol-Myers Squibb said on Thursday.
The Japanese government made reforms in 2018 that change how its national health system pays for new and innovative drugs.
But those changes are not science-based and favor large domestic
drugmakers over foreign and smaller players, Giovanni Caforio told a
news conference in Tokyo.
“The world is very competitive, and countries such as China have made
it a priority to develop a biopharmaceutical innovation-focused
industry,” Caforio said at an event organized by the Japan office of
PhRMA, the main U.S. drugmaker lobby.
Caforio was announced as chairman of PhRMA last month.
Japan’s government is seeking ways to squeeze savings from its
national health care system as the population ages. The number of
working-age people in Japan compared to those over the age of 65 is 1.8,
the lowest in the world, according to a 2019 United Nations report.
Japan is the world’s second-largest market for innovative drugs such
as gene-based therapies and cutting-edge cancer drugs. As a wealthy
country with one of the fastest ageing societies, it remains an
attractive market for global pharmaceutical makers.
Japan is also a major center for pharma research, producing drugs
such as Opdivo, a blockbuster cancer drug licensed globally by
Bristol-Myers.
The rules announced last year evaluate drugs and their makers for
innovation to determine how much the government will pay for treatments.
Catalyst Biosciences (CBIO+20%) spikes higher following a positive update
on its Phase 2 study of dalcinonacog alfa ((DalcA)), a next-generation
subcutaneously administered Factor IX therapy being developed for the
treatment of hemophilia B.
CBIO says two subjects have completed dosing and
washout, and Factor IX levels in the subjects exceeded the trial
efficacy endpoint of greater than 12% activity and no anti-drug
antibodies were detected.
The trial is expected to enroll up to six
completing subjects who will receive a single intravenous dose, followed
by daily subcutaneous doses of DalcA for 28 days; CBIO expects to
report final data in H1 2020.
The FDA approves Gilead’s (GILD+0.2%) Descovy for a pre-exposure prophylaxis indication.
Descovy for PrEP is indicated to reduce the risk
of sexually acquired HIV-1 in adults and adolescents weighing at least
35 kg who are HIV-negative and at-risk for sexually acquired HIV,
excluding those at-risk from receptive vaginal sex.
