Medical cannabis unlikely to benefit most chronic pain patients: international researchers

 Medical cannabis might be a helpful therapy for some people who have chronic pain, but it’s unlikely to benefit most, according to new clinical guidelines published Wednesday in the journal BMJ.

The guidelines, crafted by an international group of researchers who analyzed three dozen medical cannabis studies, say there isn’t enough evidence that medical marijuana products help most patients suffering from chronic pain, so they shouldn’t be widely recommended for such people.

“When we look at the overall evidence for therapeutic cannabis products, the benefits are quite modest,” said lead author Jason Busse, associate director of McMaster University’s Michael G. DeGroote Centre for Medicinal Cannabis Research in Ontario.

Even as medical marijuana has been legalized in 36 U.S. states and Washington, D.C., health care providers and patients have had little guidance on when it’s appropriate to use, especially for chronic pain. Busse and his team set out to fill that gap, but found a limited pool of studies that met their criteria because of federal restrictions that make it difficult to research medical uses of cannabis.

Because of the limited data, the guidelines do not recommend the medical use of smoked or vaped marijuana. In analyzing the available research, Busse’s team found that only small percentages of participants reported “an important improvement” in chronic pain, physical function, or sleep quality while taking oral or topical cannabis treatments.

“So medical cannabis is not likely to be a panacea. It is not likely to work for the majority of individuals who live with chronic pain. We do have evidence that it does appear to provide important benefits for a minority of individuals,” said Busse, who is also a chiropractic doctor.

The guidelines advise clinicians to cater to the specific needs of their patients, and start with non-inhaled CBD products before adding THC or other mind-altering compounds into the mix. THC is one of the ingredients in cannabis that causes a feeling of being high, but it can also cause dizziness or other side effects that might be deal-breakers for some patients.

The patient experience is a central focus of the new recommendations. In an unusual move, several “patient partners,” including former and current cannabis users, helped develop the guidelines. Busse’s center paid for developing the guidelines, and he selected the panel of experts, who were screened to ensure none had a financial interest in cannabis companies. None of the center’s funding comes from the cannabis industry, Busse said.

More research needed to guide patients

Busse hopes the paper can help clear up some of the confusion surrounding the use of medical marijuana as an analgesic, but even his guidelines contain ample gray area. Many questions remained unanswered due to a dearth of meaningful research, he said:

• Is medical cannabis safe and effective for some children, veterans, and/or people with mental health disorders?
• Is there a difference in how cancer patients and non-cancer patients with chronic pain respond to medical marijuana?
• Can medical cannabis help opioid users with chronic pain taper off these drugs?
• Do the potential risks associated with inhaling cannabis products, including lung damage, outweigh the possible benefits?

Patients have legitimate, complex reasons for wanting to try or stay away from medical cannabis, Busse said. While some people with severe chronic pain might be willing to use medical marijuana in hopes of getting even a slight bit of relief, other patients could be fine managing their pain with the standard of care and don’t want to endure potentially negative side effects.

Even when a patient decides to try medical cannabis, there are so many products, formulations, and varieties to choose from, but no definitive information on which components are most effective at treating certain symptoms.

Part of the reason for that is because much of what is on the market is a blend, unlabeled, and goes unregulated by the Food and Drug Administration, said Judith A. Paice, director of the Cancer Pain Program at Northwestern University’s Feinberg School of Medicine.

Paice, an oncology nurse, was the lead author of a set of 2016 guidelines for managing chronic pain in cancer survivors. At the time, Paice and her panel wrote there was “insufficient evidence” to recommend medical cannabis for cancer survivors with chronic pain. That hasn’t changed, despite the advances in our understanding of cancer treatment and cannabis since 2016, she told STAT.

Since cannabis is classified in the U.S. as a Schedule I Controlled Substance — the same designation given LSD and heroin — the National Institutes of Health’s “hands have been tied” when it comes to funding research on medical cannabis, Paice said.

Smoked and vaped marijuana excluded

Smoked and vaped forms of medical marijuana have not been rigorously studied when it comes to the management of chronic pain, but patients and clinicians continue to turn to inhaled products, Busse said.

“So there appears to be the potential of a rather substantial disconnect out there with respect to what patients are currently using … and what the evidence would currently support,” he said.

Karen O’Keefe, director of state policies for the Marijuana Policy Project, said clear clinical guidelines are helpful, but they would be more realistic if they included inhaled cannabis. MPP advocates for the legalization of medical marijuana in the U.S.

The exclusion of inhaled cannabis was “unfortunate,” O’Keefe told STAT, because “there are a lot of patients that use cannabis inhalation” and can get immediate, appropriately-dosed relief instead of waiting for the delayed effects that come from using edibles or other forms.

“And in reality, people are going to most likely continue to use [inhaled] cannabis — from the streets, in some cases — if that’s what works best for them,” she said.

Even inhaled cannabis, which many clinicians consider riskier than non-smoked marijuana products, is safer than opioids and other therapies people are using to manage chronic pain, O’Keefe argued.

Of the three dozen studies analyzed by Busse’s group, 21 were funded by the cannabis industry, but he said the researchers didn’t find any important differences between trials with and without industry support.

For Busse, the guidelines’ limitations underline the need for additional research on medical cannabis. Although medical marijuana has shown some promise and cannot be fatally overdosed, he wants to avoid “repeating history.”

“We spent how many decades without good evidence, increasingly promoting and prescribing opioids for chronic pain, only to realize that the benefits were less than we thought and the harms were greater than we thought,” he said. “And now there’s this struggle to sort of try to move into a different direction, and I think unless we’re cautious, we might end up repeating the same story, but with medical cannabis.”

https://www.statnews.com/2021/09/08/medical-cannabis-unlikely-to-benefit-most-chronic-pain-patients-researchers-say/

Children and COVID-19: State-Level Data Report

 State-level reports are the best publicly available and timely data on child COVID-19 cases in the United States. The American Academy of Pediatrics and the Children’s Hospital Association are collaborating to collect and share all publicly available data from states on child COVID-19 cases (definition of “child” case is based on varying age ranges reported across states; see report Appendix for details and links to all data sources).

As of September 2, over 5 million children have tested positive for COVID-19 since the onset of the pandemic. About 252,000 cases were added the past week, the largest number of child cases in a week since the pandemic began. After declining in early summer, child cases have increased exponentially, with over 750,000 cases added between August 5 and September 2.

The age distribution of reported COVID-19 cases was provided on the health department websites of 49 states, New York City, the District of Columbia, Puerto Rico, and Guam. Since the pandemic began, children represented 15.1% of total cumulated cases. For the week ending September 2, children were 26.8% of reported weekly COVID-19 cases.

A smaller subset of states reported on hospitalizations and mortality by age; the available data indicate that COVID-19-associated hospitalization and death is uncommon in children.

At this time, it appears that severe illness due to COVID-19 is uncommon among children. However, there is an urgent need to collect more data on longer-term impacts of the pandemic on children, including ways the virus may harm the long-term physical health of infected children, as well as its emotional and mental health effects.

 

Summary of Findings (data available as of 9/2/21) :

Cumulative Number of Child COVID-19 Cases*

• 5,049,465 total child COVID-19 cases reported, and children represented 15.1% (5,049,465/33,357,284) of all cases
• Overall rate: 6,709 cases per 100,000 children in the population

Change in Child COVID-19 Cases*

• 251,781 child COVID-19 cases were reported the past week from 8/26/21-9/2/21 (4,797,683 to 5,049,465) and children represented 26.8% (251,781/939,470) of the weekly reported cases
• Over two weeks, 8/19/21-9/2/21, there was a 10% increase in the cumulated number of child COVID-19 cases since the beginning of the pandemic (455,744 cases added (4,593,721 to 5,049,465))

Testing (11 states reported)*^

• Among states reporting, children made up between 10.9%-21.2% of total cumulated state tests, and between 4.8%-17.7% of children tested were tested positive

Hospitalizations (24 states and NYC reported)*

• Among states reporting, children ranged from 1.6%-4.1% of their total cumulated hospitalizations, and 0.1%-1.9% of all their child COVID-19 cases resulted in hospitalization

Mortality (45 states, NYC, PR and GU reported)*

• Among states reporting, children were 0.00%-0.27% of all COVID-19 deaths, and 7 states reported zero child deaths
• In states reporting, 0.00%-0.03% of all child COVID-19 cases resulted in death

* Note: The numbers in this summary represent cumulative counts since states began reporting. In this summary and full report, the data are based on how public agencies collect, categorize and post information. All data reported by state/local health departments are preliminary and subject to change and reporting may change over time. Notably, in the summer of 2021, some states have revised cases counts previously reported, begun reporting less frequently, or dropped metrics previously reported. For example, due to several changes on their dashboards and the data currently available, AL, NE, and TX data in this report are not current (cumulative data through 7/29/21, 6/24/21, and 8/26/21 respectively). Readers should consider these factors. States may have additional information on their web sites.

For additional information on US child hospitalizations from the CDC, visit https://covid.cdc.gov/covid-data-tracker/#new-hospital-admissions 

For additional information on US child mortality from the CDC, visit https://covid.cdc.gov/covid-data-tracker/#demographics 

^ On 7/15/21, IA stopped updating child testing data; IA cumulative tests through 7/8/21.

https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/

Biden administration readies lawsuit over Texas abortion law: Report

 The Justice Department is planning to sue the state of Texas following a recently enacted law bans abortions once a “fetal heartbeat” is detected in a woman, The Wall Street Journal reported.

Citing people familiar with the plans, the newspaper reported a lawsuit could be filed as early as Thursday, though the sources noted the timeline could be later.

It was not immediately clear what argument the department would make, but one source that spoke with The Journal predicted it would be that federal interests were illegally interfered with by the Texas law.

Last week, the Supreme Court declined to block the Texas law, which effectively bans abortions after about six weeks of pregnancy. It was signed by Texas Gov. Greg Abbot on June 16 and became effective last week.

The law empowers private citizens to enforce the measure, awarding them $10,000 each time they are able to successfully sue someone who carries out or facilitates an abortion.

President Biden called the law "almost un-American" last week.

Additionally, abortion rights advocates are concerned that states, empowered by the recent 5-4 Supreme Court decision last week, will introduced their own "copy cat" laws. 

 

Earlier this week, Attorney General Merrick Garland issued a statement on the law, saying that the Department of Justice was going to explore its options in an effort to protect the constitutional rights of women seeking to have an abortion.

 

“While the Justice Department urgently explores all options to challenge Texas SB8 in order to protect the constitutional rights of women and other persons, including access to an abortion, we will continue to protect those seeking to obtain or provide reproductive health services pursuant to our criminal and civil enforcement of the FACE Act," Garland said in a statement on Monday.

 

“The department will provide support from federal law enforcement when an abortion clinic or reproductive health center is under attack. We have reached out to U.S. Attorneys’ Offices and FBI field offices in Texas and across the country to discuss our enforcement authorities," he added.

 

Democrats on the House Judiciary Committee wrote to Garland on Tuesday following his statement urging the department to take up legal action against "would-be vigilantes" who may try to enforce the Texas law themselves. 

“We urge you to take legal action up to and including the criminal prosecution of would-be vigilantes attempting to use the private right of action established by that blatantly unconstitutional law,” the lawmakers wrote.

https://thehill.com/regulation/court-battles/571440-biden-administration-readies-lawsuit-over-texas-abortion

Price Control Debate Heats Up in Washington and Within the Industry

 In January, Dr. Michelle McMurry-Heath, chief executive officer of Biotechnology Innovation Organization (BIO), reorganized the leadership structure of the trade group to provide what was expected to be “long-term stability for the organization.” However, recent reports have suggested that stability has not been achieved.

Multiple reports from STAT News suggest an exodus of team members, particularly lobbyists tasked with meeting Congressional and state legislators' leadership. Much of the turmoil centers on drug-pricing policy, which has been a hot-button issue in the pharmaceutical industry for years. According to the STAT report, a number of pharmaceutical executives have been pushing the organization to support calls for drug-pricing controls, particularly regarding Medicare, while another segment has been adamantly opposed. Those executives opposed to pricing controls have argued that the industry would be negotiating against itself.

When McMurry-Heath announced the reorganization in January, she said the plan would support BIO’s goals of advocacy, education and collaboration. The agency has placed its leadership vision on five different pillars: Be a voice of science and for science, unite and empower biotech innovators and their ecosystem to improve lives, remove barriers to innovation, champion broad access to biotech breakthroughs and scientific equality, and catalyze resilient and sustainable bio-based economies.

While some of BIO’s members have championed drug-pricing controls, the organization has expressed uncertainty about plans promoted by the Biden administration. In August, Rich Masters, BIO’s chief public affairs and advocacy officer, called the Biden plan “the wrong approach.” Masters said it would ultimately restrict access to critical medicines and negatively impact small, innovative biotech companies seeking capital needed to discover new medicines. Masters maintained the industry stance that the plan allowing Medicare to negotiate prices will create new barriers for medical innovation.

 “BIO has made clear our desire to advocate for policy reforms that lower patient spending at the pharmacy counter without compromising scientific advancement and the support needed to usher in the next generation of cures and breakthrough medicines. Unfortunately, the president’s plan is no such reform,” Masters said in a statement.

Masters' comments regarding disruption to innovation echo similar concerns raised by other industry leaders and advocacy organizations. Last week, an analysis released by the nonpartisan Congressional Budget Office (CBO) supported the idea that an overhaul of Medicare that includes the ability to negotiate prices would hinder long-term innovation. The CBO analysis estimates the policy in HR3, which was passed by the U.S. House of Representatives and supported by the administration, will lead to two fewer drugs in the first decade, 23 fewer over the next decade, and 34 fewer drugs in the third decade.

While there may be some growing pains within BIO, the organization has come out in support of the seventh renewal of the Prescription Drug User Fee Act (PDUFA). BIO said PDUFA “continues to enhance and strengthen” the U.S. Food and Drug Administration (FDA) by “fulfilling its public health mission and ensure that safe, effective, and high-quality new drugs and biological products are reviewed in an efficient and predictable time frame.” BIO went on to say the reauthorization will strengthen scientific dialogue between the industry and the regulatory agency.

https://www.biospace.com/article/growing-pains-at-bio-as-price-control-debate-heats-up-in-washington-and-within-the-industry/

PhRMA Warns of Dire Consequences if Medicare Allowed to Negotiate Drug Prices

 Pharmaceutical industry representatives said Wednesday that proposals now being considered on Capitol Hill to lower patients' prescription drug costs likely will have damaging effects on new drug development and on patients' access to new medications.

As part of a $3.5 trillion infrastructure bill, "lawmakers want to offset this amount of new spending by allowing federal officials to 'negotiate' prices for prescription drugs," Steve Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), a lobbying group for the pharmaceutical industry, said during a press briefing. "We know how the story ends when the government gets into the business of setting prices."

"In countries where governments do set the price, patients often have delayed access, if access at all" to new treatments, he continued. While Americans have access to about 90% of all FDA-approved new treatments and cures, "if you look at other countries with government price-setting, in the U.K. it's about 60% [access], in France, 48% and Canadians have 44% access to the treatments that are readily available to Americans."

Ubl acknowledged that the current system needs to be changed, "and we've put forward to our own ideas on modernizing Medicare and making insurance work like insurance again. We're not for the status quo ... We're willing to come to the table in good faith, and work with lawmakers on better policies."

Specifically, the industry is concerned about H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act, which would require the Department of HHS to negotiate prices for certain single-source, brand-name drugs that don't have generic competition. The negotiated maximum price may not exceed 120% of the average price in five countries -- Australia, Canada, France, Germany, Japan, and the U.K. The negotiated prices must be offered under Medicare and may also be offered under private health insurance.

The bill also requires drug manufacturers to issue rebates to CMS for covered drugs that cost $100 or more and for which the average manufacturer price increases faster than inflation, and reduces the annual out-of-pocket drug spending threshold for Medicare beneficiaries.

Ken Frazier, executive chairman of Merck's board of directors, warned about the negative effect that H.R. 3 might have on drug research and development (R&D).

"If we choose to make the choices inherent in H.R. 3, it will mean that we will lose that substantial funding for R&D, which means we will forego many important discoveries that will have an impact not just on the economy, not just on this industry, but on the many people who are waiting for those cures and treatments to come forward," he said. "There's simply no way to sustain today's research budgets under these scenarios."

PhRMA board chairman David Ricks noted that the bill would "extract $600 billion -- with a B -- dollars from an industry that annually, has about $350 billion in sales. So this is a huge reduction over the course of 10 years, but it also directs the Congress to look at ways to reduce prices across the entirety of the U.S. marketplace -- not just the government formularies."

"Our estimates are that it would be a $1.5 trillion cost to our industry over the course of 10 years, raising only $600 billion for the government. That's inefficient, and it will have a significant secondary effect on our industry," he added.

Ricks, who is also chairman and CEO of drugmaker Eli Lilly said that his organization and member companies "want to be part of a solution that will lower out-of-pocket costs for patients for the innovative medicines our industry makes, but we cannot support and will not support policies that also restrict patient access and destroy our ability to develop the next generation of innovative new products."

Seniors are concerned about the bill's potential effects as well, he added, citing a February 2019 Kaiser Family Foundation poll of a nationally representative sample of 1,440 adults ages 18 and older.

"Even the Kaiser Family Foundation, who often does polling that we don't agree with ... polled seniors about whether they want to go to negotiation, 65% oppose negotiation when they understand it will reduce access to new medicines," Ricks noted.

Those poll results contrast with a poll released in June by Gallup and West Health, a group of nonpartisan organizations focused on lowering healthcare costs. That poll, which included a nationally representative sample of more than 3,700 American adults, found that nearly all Democrats (97%) and the majority of Republicans (61%) supported price negotiation by the federal government, and less than 20% of all Americans believe Medicare negotiation would hurt innovation or market competition.

"Americans aren't buying the claim that attempts to reign in drug prices will stifle innovation and devastate the pharmaceutical industry," Tim Lash, West Health's chief strategy officer, said in a statement. "These misleading arguments are meant to preserve profits rather than protect patients. The time has come to finally enable Medicare negotiation. Americans are becoming increasing[ly] restless for it to happen, even if the pharmaceutical companies are not."

At the briefing, PhRMA officials did not discuss any specifics of their plans for lowering drug prices, but the organization's website lists several proposals, including instituting caps on annual out-of-pocket costs for beneficiaries in the Medicare Part D prescription drug program, sharing savings from drug rebates with patients at the pharmacy counter rather than giving the rebates to insurers, and using a "market-based adjustment" system to lower some drug prices under the Medicare Part B program.

https://www.medpagetoday.com/publichealthpolicy/generalprofessionalissues/94411

Surgical robotics developer PROCEPT BioRobotics files for a $100 million IPO

PROCEPT BioRobotics, which makes a surgical robotic system for minimally-invasive urologic surgery, filed on Wednesday with the SEC to raise up to $100 million.

PROCEPT BioRobotics is a commercial-stage surgical robotics company focused on advancing patient care by developing transformative solutions in urology. The company develops, manufactures, and sells the AquaBeam Robotic System, a surgical robotic system for use in minimally-invasive urologic surgery with an initial focus on treating benign prostatic hyperplasia. Its proprietary AquaBeam Robotic System employs a single-use disposable handpiece to deliver its Aquablation therapy. As of June 30, 2021, PROCEPT BioRobotics had an installed base of 124 AquaBeam Robotic Systems, and Aquablation therapy had been utilized in the treatment of more than 5,500 patients.

The Redwood City, CA-based company was founded in 2009 and booked $21 million in sales for the 12 months ended June 30, 2021. It plans to list on the Nasdaq under the symbol PRCT. BofA Securities, Goldman Sachs, Cowen, Guggenheim Securities, and SVB Leerink are the joint bookrunners on the deal. No pricing terms were disclosed.

Relevant Profile: PRCT

https://www.renaissancecapital.com/IPO-Center/News/85348/Surgical-robotics-developer-PROCEPT-BioRobotics-files-for-a-$100-million-IP

Quebec Orders All Health-Care Workers To Get Vaccinated Or Be Suspended Without Pay

 he province of Quebec has become the latest local government (and the first in Canada) to decree that all nurses working in the province will need to get vaccinated by Oct. 15, or they will be suspended without pay, according to the province's health minister, Christian Dubé, who made the announcement on Tuesday.

The decision isn't exactly a surprise. Dubé and Quebec Premier François Legault have said in recent weeks that they intended to make vaccination mandatory for health-care workers, but they didn't specify a deadline or consequences for workers who didn't follow the mandate until Tuesday, when Dubé made the announcement during a provincial update.

For weeks, such events have been led by Dubé, accompanied by Public Health Director Dr. Horacio Arruda. But given the gravity of the announcement, Legault returned to lead the news conference himself for the first time in weeks.

Legault noted the number of hospitalizations in the province had climbed to 171 from 55 a month ago. And when asked which workers will be affected by the mandate, Dubé responded: "Everybody … 100 per cent of employees."

Vaccine passports will also be required for visitors to hospitals, he added.

It's not just nurses who will be affected: doctors, midwives, professionals in private clinics and volunteers will all need to be vaccinated before entering a hospital.

With COVID cases rising once again in the province, Legault said Tuesday that Quebec would need to reorganize its hospital system: "For a while, we're going to have to accept a certain amount of risk. We don't want another lockdown, so we're going to have to accept that there will be hospitalizations for COVID-19 for a while." "We are going to have to reorganize the health-care system."

One strategy is they are trying to convince people who have left the profession to return.

Others criticized the policy, saying they're not sure it's the right call.

Jeff Begley, head of the federation of health and social services union, said he wasn't surprised by the government's announcement, but he wasn't sure they had made the best decision.

"We're not sure that it's the best means going forward," he said.

Begley explained that most hospitals have eliminated their "hot" sections for COVID patients (since most people are vaccinated now). Begley believes this may have been a mistake, and that COVID patients must be quarantined in hospitals to avoid infecting others.

As of Tuesday, 87% of Quebecers have had at least one dose of the vaccine. Legault pleaded with those watching to try and convince at least one person who hasn't been vaccinated to get the jab.

Still, if the province is trying to improve its ability to deal with the pandemic, suspending nurses and doctors from their jobs without pay doesn't seem like the best way to go.

https://www.zerohedge.com/geopolitical/quebec-orders-all-health-care-workers-get-vaccinated-be-suspended-without-pay