After unanimously voting to recommend a miraculous hepatitis C drug for approval in 2013, a panel of experts advising the Food and Drug Administration gushed about what they’d accomplished.
“I voted ‘yes’ because, quite simply, this is a game changer,” National Institutes of Health hepatologist Dr. Marc Ghany said of Sovaldi, Gilead Science’s new pill designed to cure most cases of hepatitis C within 12 weeks.
Dr. Lawrence Friedman, a professor at Harvard Medical School, called it his “favorite vote” as an FDA reviewer, according to the transcript.
What the panelists didn’t know was that the FDA’s drug quality inspectors had recommended against approval.
They issued a scathing 15-item disciplinary report after finding multiple violations at Gilead’s main U.S. drug testing laboratory, down the road from its headquarters in Foster City, Calif. Their findings criticized aspects of the quality control process from start to finish: Samples were improperly stored and catalogued; failures were not adequately reviewed; and results were vulnerable to tampering that could hide problems.
Gilead Foster City doesn’t manufacture drugs. Its job is to test samples from drug batches to ensure the pills don’t crumble or contain mold, glass or bacteria, or have too little of an active antiviral ingredient.
Recent news reports have focused public attention on poor quality control and contamination in the manufacturing of cheap generic drugs, particularly those made overseas. But even some of the newest, most expensive brand-name medicines have been plagued by quality and safety concerns during production, a Kaiser Health News analysis shows.
More disturbing, even when FDA inspectors flagged the potential danger and raised red flags internally, those problems were resolved with the agency in secret ― without a follow-up inspection ― and the drugs were approved for sale.
Erin Fox, who purchases medicines for University of Utah Health hospitals, said she was shocked to hear from KHN about manufacturing problems uncovered by authorities at the facilities that make brand-name products. “Either you’re following the rules or you’re not following the rules,” Fox said. “Maybe it’s just as bad for branded drugs.”
The pressure to get innovative drugs like Sovaldi into use is considerable, both because they offer new treatments for desperate patients and because the medicines are highly profitable.
Against that backdrop, the FDA has repeatedly found a way to approve brand-name drugs despite safety concerns at manufacturing facilities that had prompted inspectors to push to reject those drugs’ approval, an ongoing KHN investigation shows. This happened in 2018 with drugs for cancer, migraines, HIV and a rare disease, and 10 other times in recent years, federal records show. In such cases, how these issues were discussed, negotiated and ultimately resolved is not public record.
For example, inspectors found that facilities making immunotherapies and migraine treatments didn’t follow up when drug products showed evidence of bacteria, glass or other contaminants. At a Chinese plant making the new HIV drug Trogarzo, employees dismissed “black residue” found to be “non-dissolvable metal oxides,” assuming it “did not pose a significant risk,” federal records show.
Without a follow-up inspection to confirm drugmakers corrected the problems inspectors found, these medicines eventually were approved for sale, and at list prices as high as $189,000 a month for an average patient, according to health data firm Connecture. The cancer drug Lutathera was initially rejected over manufacturing problems at three plants but was approved a year later without a fresh inspection and was priced at $57,000 per vial.
John Avellanet, a consultant on FDA compliance, said data integrity problems, like those at Gilead’s lab in Foster City, should have sparked further investigation, because they raise the possibility of “deeper issues.”
Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, said an inspector’s recommendation to withhold approval can be “dealt with” without a follow-up. Woodcock said the agency can’t comment on specifics, and companies are reluctant to discuss them because the details of the resolution are protected as a corporate trade secret.
“That doesn’t mean that there’s anything wrong with the drug,” Woodcock said.
Dinesh Thakur, a former drug-quality employee turned whistleblower, called the secrecy a “red flag.” A follow-up inspection is critical, he said: “I’ve seen many times paper commitments are made but never followed through.”
What worries Fox is that a faulty drug could get through and nobody would know.
“In general, very few people suspect that their medicine is the problem or their medicine is not working,” Fox said. “Unless you see black shavings or something horrible in the product itself, the drug is almost the last thing that would be suspect.”
The Market Beckons
If the FDA finds problems at preapproval inspections for generics, the agency is likely to deny approval and delay the drug’s launch until the next year’s review cycle, according to industry and agency experts.
In fact, just 12% of generics were approved the first time their sponsors submitted applications from 2015 through 2017.
The calculus appears different for heralded new therapies like Sovaldi. In 2018, 95% of novel drugs ― the newest of the new ― were approved on the first try, the FDA said.
Woodcock said the agency has “the same standards for all drugs,” but she emphasized that many of the manufacturing issues “are somewhat subjective.”
For new brand-name drugs, she said, the FDA “will work very closely with the company to … bring the manufacturing up to snuff.”
The manufacturer submits written responses and commits to resolve quality concerns, but the details are kept confidential.
An estimated 2.4 million Americans have hepatitis C and, before Sovaldi, treatment came with miserable side effects and a strong chance it wouldn’t work. Sovaldi promised up to a 90% cure rate, though it came with an eye-popping $84,000 price tag for a 12-week course, putting it out of reach for most patients and health care systems.
But corporate pressure to get such therapies into the marketplace is also considerable.
Pharmaceutical firms pay hefty fees for FDA review and lobby the agency to speed products to market. For Gilead, time lost is money.
“If approval of sofosbuvir were delayed, our anticipated revenues and our stock price would be adversely affected,” Gilead wrote in an SEC document filed Oct. 31, 2013, using the generic name for Sovaldi.
Since its debut in 2013, Sovaldi has been widely criticized for its price but recognized as a medical breakthrough. Gilead has never recalled it.
However, hundreds of patients who have taken the drug have voluntarily reported cancer or other complications to the FDA’s “adverse event” reporting database, including concerns that the treatment doesn’t always work. One in 5 Sovaldi patients and health care professionals who reported serious problems to federal regulators said the drug didn’t cure the patients’ hepatitis C.
“The FDA approved these products after a rigorous inspection process, and we are confident in the quality/compliance of these products,” Gilead spokeswoman Sonia Choi said.
Problems at Foster City
Gilead’s Foster City facility has been cited for an array of problems over the years. In 2012, FDA inspectors said the facility had failed to properly review how the HIV drugs Truvada and Atripla became contaminated with “blue glass” particles; some of that tainted batch was distributed. The company “made no attempt to recover” the contaminated drugs, according to FDA inspection records.
Gilead had just filed its application for Sovaldi’s approval when FDA inspectors arrived at Foster City for an unrelated inspection in April 2013. Inspectors slapped the facility with nine violations in what’s called a 483 document and said that the reliability of the site’s methods for testing things like purity were unproven and that its records were incomplete and disorganized, according to FDA inspection documents.
As a result, the FDA initially rejected two HIV drugs, Vitekta and Tybost. Gilead had to resubmit those applications, and it would take 18 months before the FDA approved them in late 2014.
On Sept. 19, 2013, FDA officials met to discuss Sovaldi with Woodcock, agency records show. Meeting minutes show inspectors recommended hitting Gilead Foster City with a formal warning letter based on the April inspection. (A warning letter is a disciplinary action from the FDA that typically includes a threat to withhold new approvals or place a foreign facility on import alert and refuse to accept its products for sale in the U.S.)
At the same meeting, FDA inspectors said their recommendation to approve Sovaldi would be “based on” removing an unnamed drug ingredient manufacturer from the application and “a determination that Gilead Foster City has an acceptable cGMP [current good manufacturing practices] status.”
Records show the FDA didn’t issue a warning letter or otherwise delay the approval process when Foster City failed its inspection.
Instead, the Sovaldi preapproval inspection started four days later and lasted two weeks. At the end, inspectors issued Foster City another 483, this time with 15 violations, formally outlining problems and requiring a written plan to fix them. Inspectors said they couldn’t recommend Sovaldi’s approval.
FDA officials gave Gilead two options during an Oct. 29 teleconference: Remove Foster City, a “major testing site” for Sovaldi, from the application, and use a third-party contractor instead; or use Foster City but hire another firm to monitor the site and sign off on its testing work.
Gilead was optimistic. “Based on recent communications with the FDA, we do not expect these [inspection] observations to delay approval of sofosbuvir,” the company said in its Oct. 31 SEC filing.
Gilead chose to replace the Foster City plant with a contract testing site, federal records show. By December, Sovaldi was approved for distribution, and the company soon announced its $1,000-per-pill price tag.
Not Just Generics
Recent media reports, and the ongoing recall of the widely used blood pressure medicine valsartan, have led consumers ― and members of Congress ― to question whether generics are manufactured safely. Valsartan pills made in China and India were found to contain cancer-causing impurities.
Branded-drug quality, in large part, has been spared from congressional scrutiny. But many factories ― overseas and in the U.S. ― make branded and generic drugs.
In January 2018, FDA inspectors hit a Korean manufacturing plant that makes Ajovy, a migraine drug, with a warning letter. With the problems still unresolved in April, an agency reviewer recommended withholding approval. When they returned in July, inspectors wanted to give the plant the worst possible classification: “Official Actions Indicated.” Among other problems, inspectors found that glass vials sometimes broke during the manufacturing process and that the facility lacked protocols to prevent the particles from getting into drug products. The FDA’s Office of Manufacturing Quality eventually downgraded the inspection to just “Voluntary Actions Indicated.”
The drug was approved in September 2018 and priced at $690 a month. FDA records indicate no further disciplinary action was taken. Teva, the maker of Ajovy, did not respond to requests for comment.
Similarly, when FDA inspectors visited a contract manufacturing facility in Indiana used to make Revcovi, which treats an autoimmune disease, they noted that a redacted drug lot had failed a sterility test because the vials tested positive for a bacterium called Delftia acidovorans, which can be detrimental even in people with healthy immune systems, studies show. But the drug-filling machine stayed in use after the contaminant was discovered, the FDA determined. Inspectors recommended withholding approval.
The drug was approved in October 2018 even after another inspection turned up problems, with a list price of $95,000 to $189,000 per month for an average patient, according to health care data firm Connecture.
Revcovi’s manufacturer, Leadiant Biosciences, said through an outside public relations firm that its contract manufacturer’s written responses to the FDA observations were considered “adequate” by two FDA offices, adding, “We do not have any more information to share with you at this time as pharmaceutical manufacturing processes are confidential.”
Problems with drugs can take years to discover ― and then only after patients are injured. So, many health researchers say, more caution is warranted.
“They’re doing so few of these [FDA] inspections pre-market,” said Diana Zuckerman, president of the nonprofit National Center for Health Research. “The least they can do is listen to the ones they’re doing.”
By: Sydney Lupkin, Kaiser Health News
Title: FDA Keeps Brand-Name Drugs on a Fast Path to Market ― Despite Manufacturing Concerns
Sourced From: www.thefix.com/fda-keeps-brand-name-drugs-fast-path-market-despite-manufacturing-concerns
Published Date: Thu, 23 Jan 2020 07:50:29 +0000
At New Horizon Drug Rehab, we understand addiction. If you or a family member are afflicted with addiction or substance abuse we can help. We work with the top centers throughout the US to provide the best detox and addiction treatments available.
Call Now: (877) 747-9974
In the lead-up to the 2020 elections, the Journalist’s Resource team is combing through the Democratic presidential candidates’ platforms and reporting what the research says about their policy proposals. We want to encourage deep coverage of these proposals — and to do our part to help deter horse race journalism, which research suggests can lead to inaccurate reporting and an uninformed electorate. Our criteria for the proposals we’re covering is simple: We’re focusing on proposals that have a reasonable chance of becoming policy, and for us that means at least 3 of the 5 top-polling candidates say they intend to tackle the issue. Here we look at candidates’ proposals to address the opioid epidemic. Candidates are divided in their approaches; while nearly all favor increasing funding for and access to treatment for opioid use disorder, fewer candidates support harm reduction policy interventions, such as safe injection sites and needle exchanges. A few candidates incorporate broader criminal justice-level changes or physician-level interventions into their policy proposals.
Candidates favoring increased funding for and access to treatment
Michael Bennet, Joe Biden, Cory Booker*, Pete Buttigieg, John Delaney, Amy Klobuchar, Bernie Sanders, Tom Steyer, Elizabeth Warren, Marianne Williamson*, Andrew Yang
Candidates favoring harm reduction interventions
Michael Bennet, Cory Booker, Pete Buttigieg, Amy Klobuchar, Bernie Sanders, Elizabeth Warren
Candidates favoring action against pharmaceutical companies
Michael Bennet, Cory Booker, Pete Buttigieg, John Delaney, Tulsi Gabbard, Amy Klobuchar, Bernie Sanders, Elizabeth Warren, Andrew Yang
Candidates favoring interventions that target physician prescribing behavior
John Delaney, Amy Klobuchar, Andrew Yang
Candidates favoring decriminalization of possession of opioids
Pete Buttigieg, Andrew Yang
What the research says
Access to treatment: Medication-assisted treatment is an evidence-based treatment for opioid use disorder; it has been shown to reduce the risk of overdose death for people who use opioids. Methadone, buprenorphine and naltrexone are types of medication-assisted therapy for opioid use disorder. These medications reduce symptoms of craving and withdrawal. A systematic review and meta-analysis of medication-assisted treatment find that people receiving such treatment were less likely to die of an overdose or other causes than their peers with opioid use disorder who did not receive medication-assisted treatment.
Harm reduction: Harm reduction initiatives attempt to reduce the risks associated with using drugs. Such initiatives include needle exchange programs, widespread distribution of the opioid overdose antidote naloxone and supervised injection facilities. Supervised injection facilities, also known as safe injection sites or supervised consumption facilities, are not legal in the U.S. They exist legally in other countries, such as Canada and Australia, however.
Several studies have demonstrated a positive link between safe injection site use and entry into treatment. Safe injection sites also provide benefits to people who use drugs in the form of sterilized equipment and supervision to mitigate the dangers of overdose.
Over a dozen studies have linked needle exchanges with lower rates of hepatitis C and HIV infection among people who inject drugs.
A systematic review of research on take-home naloxone programs, which provide people at risk of opioid overdose with kits including the antidote, concludes that “there is overwhelming support of take-home naloxone programs being effective in preventing fatal opioid overdoses.”
The pharmaceutical industry: Big Pharma’s role in marketing opioids spurred physicians to prescribe more opioids, research shows. This, in turn, fueled the opioid epidemic the country faces today. Policies targeted toward Big Pharma include proposals to hold industry players liable for their role in the opioid epidemic with criminal penalties and fines.
Decriminalization: The rationale behind decriminalization of the personal use of narcotics is that criminal penalties essentially criminalize substance use disorder. Proponents of decriminalization argue that such drug use should, instead, be met with evidence-based treatment. There is not much research on the effects of decriminalization because it’s rare. However, in 2001, Portugal decriminalized personal acquisition, possession and use of illicit drugs. Research indicates that drug-related deaths have fallen since the southwestern European country decriminalized illicit drugs.
Physician-level interventions: These interventions target prescriber behavior. Examples include physician education programs, guidelines or restrictions on the quantity of opioids physicians can prescribe, and prescription monitoring programs that allow physicians to view patients’ prescription history to avoid overprescribing or illegitimate prescribing. While education and prescribing policies have curtailed prescribing habits, prescription monitoring programs have been less successful, studies indicate.
Key context
In late 2017, the U.S. Department of Health and Human Services declared the nation’s opioid crisis a “public health emergency.” The problem has been building for over a decade, spurred by sharp increases in prescriptions for opioids, commonly used to treat both short-term and chronic pain.
About 233.7 million opioid prescriptions were filled each year, on average, from 2006 to 2017, according to a March 2019 study in JAMA Network Open that looks at opioid prescriptions filled in retail pharmacies across the U.S.
Prescription painkillers have a high risk of abuse — across the academic literature, rates of misuse among patients taking opioids for chronic non-cancer pain average between 21% and 29%. Research indicates that as of 2013, more than 2 million people in the U.S. had prescription opioid-related opioid use disorder.
Prescription opioids can also pave the way for illegal drugs like heroin. Eighty percent of people who have used heroin have previously misused prescription opioids, according to an August 2013 analysis of national survey data collected from 2002 to 2011.
As opioid use and misuse has increased, deaths linked to the drugs have increased. In 2017, opioids were involved in 47,600 drug overdose deaths, accounting for nearly 70% of all overdose deaths nationwide that year.
Recent research
Access to treatment:
A review of randomized controlled trials comparing medication-assisted treatment of opioid use disorder to placebo or no medication finds that medication-assisted treatment “at least doubles rates of opioid-abstinence outcomes.”
A study of 151,983 adults in England treated for opioid dependence between 2005 and 2009 finds that the risk of fatal drug overdose more than doubled for individuals who received only psychotherapy compared with those who received medication-assisted treatment.
Harm Reduction:
Two reviews — one published in Drug and Alcohol Dependence in 2014, and one published in Current HIV/AIDS Reports in 2017 — indicate that supervised consumption facilities promote help people access treatment. The more recent review looks at 47 studies published between 2003 and 2017 on supervised drug consumption facilities. The authors find a handful of studies that demonstrate a positive link between safe injection site use and starting treatment.
One of these studies compared enrollment in detoxification programs among those who used Vancouver’s supervised injection facility the year before and after it opened in 2003. Researchers find the facility’s opening was linked to a 30% increase in detox program use, which, in turn, was linked to pursuing long-term treatment and injecting at the facility less often. A later study of the injection facility focused on use of detox services located at the facility. It finds that 11.2% (147 people) used these services at least once over the two years studied. The authors conclude that supervised injection facilities might serve as a “point of access to detoxification services.”
A 2006 study of 871 people who injected drugs finds no substantial increase in rates of relapse among former users before and after the Vancouver site opened. However, the researchers also find no substantial decrease in the rate of stopping drug use among current users before and after the site opened. Another study of 1,065 people at this facility published in 2007 finds that only one individual performed his or her first injection at the site.
Though supervised injection sites are illegal in the U.S., one opened underground in 2014. Researchers interviewed those who used the underground site during its first two years of operation and their findings were published in 2017 in the American Journal of Preventive Medicine. The site’s users were asked the same set of questions about their use patterns every time they injected drugs at the site. The authors conclude that the site offered several benefits, including safe disposal of equipment, unrushed injections and immediate medical response to overdoses. The authors add that if the site were sanctioned, it might be able to offer additional benefits, including health care and other services.
Big Pharma:
Research suggests that physicians targeted with marketing from pharmaceutical companies prescribe opioids at higher rates than doctors not exposed to their marketing.
Several studies use data from the Centers for Medicare and Medicaid Services’ Open Payments database, which tracks payments made by drug and medical device companies to physicians. That information is used to analyze how relationships between physicians and drug companies are linked to prescriptions written.
These studies define opioid-related payments as cash payments — for example, speaking fees associated with promoting a drug — and payments-in-kind — free meals pharmaceutical representatives provide to doctors’ offices, for instance. These studies find that physicians who receive opioid-related payments tend to prescribe more opioids.
A study in PLoS One from December 2018 looks at physicians who received opioid-related payments, some in 2014 and some in 2015, compared with doctors who never received such payments. The authors find that physicians who received opioid-related payments had a larger increase in the number of daily doses of opioids dispensed, as well as in total opioid expenditures, prescribing pricier opioids per dose.
Another study looking at the same data offers further detail. The study, published in Addiction in June 2019, focuses on 865,347 physicians across the country who filled prescriptions for Medicare patients from 2014 to 2016. “Prescribers who received opioid-specific payments prescribed 8,784 opioid daily doses per year more than their peers who did not receive any such payments,” the authors write.
Other research geographically links opioid marketing and opioid-related overdose mortality. The paper, published in JAMA Network Open in January 2019, analyzes county-level prescription opioid overdose deaths and county-level opioid marketing payments.
The authors find that deaths from prescription opioid overdoses increased with each standard deviation increase in opioid marketing as measured by dollars spent per capita, number of payments to physicians per capita and number of physicians receiving payments per capita. Standard deviation indicates the variation of a given value from the average. “Opioid prescribing rates also increased with marketing,” the authors write. They note that the higher prescription rate might be why overdose deaths increased.
Physician-level interventions:
An August 2018 study published in Science highlights the role physician education might play in addressing the nation’s opioid crisis. The intervention was simple: When a patient died of an opioid overdose, the county medical examiner sent the prescribing physicians a letter notifying them. The authors conducted a randomized trial of 861 physicians whose patients overdosed. The intervention group received the letter, which included a safe prescribing warning consisting of these recommendations:
- Avoid co-prescribing an opioid and a benzodiazepine.
- Minimize opioid prescribing for acute pain.
- Taper long-term users off opioids.
- Avoid prescriptions lasting for three consecutive months or longer and prescribe naloxone, an opioid overdose antidote.
The control group received no communication.
Physicians in the intervention group cut their opioid prescribing by 9.7% — as measured by milligram morphine equivalents in prescriptions filled — in the three months after the letter was sent. These physicians also started fewer patients on opioids and wrote fewer high-dose prescriptions than the control group.
Prescribing policies and guidelines also have successfully curbed physicians’ distribution of opioids.
In October 2017, the Michigan Opioid Prescribing Engagement Network released opioid prescribing guidelines for nine surgical procedures to clinicians participating in the Michigan Surgical Quality Collaborative, a statewide initiative to improve surgical care.
Researchers compared opioid prescribing before and after these guidelines were released, analyzing data from 11,716 patients across 43 hospitals collected from February 2017 to May 2018. They find that prescriptions declined, on average, from 26 pills to 18 pills per month after the guidelines were released.
Patients also took fewer of the pills they were prescribed. As measured by patient-reported survey data, opioid consumption following surgery dropped from 12 pills to nine, “possibly as a result of patients anchoring and adjusting their expectations for opioid use to smaller prescriptions,” explain the authors of the August 2019 New England Journal of Medicine study. Although patients received smaller prescriptions and used fewer pills after the guidelines were published, there were no substantial changes in the patients’ satisfaction and pain scores.
Similar to the study of Michigan’s opioid prescribing guidelines is a February 2018 study in the American Journal of Emergency Medicine that tracks the effects of an emergency department opioid prescribing policy. The policy resulted in declines in opioid prescriptions. Compared with the control emergency department, the two intervention hospitals had a more pronounced decline in opioid prescribing. The authors conclude that emergency department-based policies might help reduce opioid prescribing.
Prescription drug monitoring programs, which allow physicians to view patients’ prescription history to avoid overprescribing or prescribing opioids to people who don’t actually need them, have been shown to be less effective. A January 2018 study of national data published in Addictive Behaviors finds that there were not statistically significant differences in the likelihood that physicians would prescribe opioids for chronic pain when comparing states with prescription drug monitoring programs with those without.
Further reading
General overview
Modeling Health Benefits and Harms of Public Policy Responses to the US Opioid Epidemic
Allison L. Pitt, Keith Humphreys and Margaret L. Brandeau. American Journal of Public Health, October 2019.
The gist: “Policies focused on services for addicted people improve population health without harming any groups. Policies that reduce the prescription opioid supply may increase heroin use and reduce quality of life in the short term, but in the long term could generate positive health benefits. A portfolio of interventions will be needed for eventual mitigation.”
Safe injection sites
Attendance at Supervised Injecting Facilities and Use of Detoxification Services
Evan Wood, Mark W. Tyndall, Ruth Zhang, Jo-Anne Stoltz, Calvin Lai, Julio S.G. Montaner and Thomas Kerr. New England Journal of Medicine, June 2006.
The gist: A study of Vancouver’s supervised injection facility finds “an average of at least weekly use of the supervised injecting facility and any contact with the facility’s addictions counselor were both independently associated with more rapid entry into a detoxification program.”
Injection Drug Use Cessation and Use of North America’s First Medically Supervised Safer Injecting Facility
Kora DeBeck, Thomas Kerr, Lorna Bird, Ruth Zhang, David Marsh, Mark Tyndall, Julio Montaner and Evan Wood. Drug and Alcohol Dependence, January 2011.
The gist: “These data indicate a potential role of SIF [supervised injecting facilities] in promoting increased uptake of addiction treatment and subsequent injection cessation.”
“A Little Heaven in Hell”: The Role of a Supervised Injection Facility in Transforming Place
Ehsan Jozaghi. Urban Geography, May 2013.
The gist: “Participants’ narratives indicate that attending InSite [Vancouver’s supervised injection facility] has had numerous positive effects in their lives, including changes in sharing behavior, improving health, establishing social support and saving their lives.”
Process and Predictors of Drug Treatment Referral and Referral Uptake at the Sydney Medically Supervised Injecting Centre
Jo Kimber, Richard P. Mattick, John Kaldor, Ingrid Van Beek, Stuart Gilmour and Jake A. Rance. Drug and Alcohol Review, May 2009.
The gist: Researchers conducted 1.5-year study at a supervised injection site in Sydney. They find that 16% of clients at the site referred to treatment by health and social welfare professionals went on to receive it, leading the authors to conclude that the center “engaged injecting drug users successfully in drug treatment referral and this was associated with presentation for drug treatment assessment and other health and psychosocial services.”
Inability to Access Addiction Treatment and Risk of HIV Infection Among Injection Drug Users Recruited from a Supervised Injection Facility
M.-J.S. Milloy, Thomas Kerr, Ruth Zhang, Mark Tyndall, Julio Montaner and Evan Wood. Journal of Public Health, September 2012.
The gist: Many who use supervised injection facilities have the desire to access treatment. This study surveyed 889 people who were randomly selected to be surveyed at Vancouver’s supervised injection facility. “At each interview, ∼20 percent of respondents reported trying but being unable to access any type of drug or alcohol treatment in the previous 6 months,” the authors write. The main barrier to access, respondents said, was waiting lists for treatment.
Big Pharma
The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy
Art Van Zee. American Journal of Public Health, February 2009.
The gist: In the first six years it was on the market, Purdue Pharma spent about six to 12 times more to promote OxyContin than it had to promote another long-lasting opioid. The paper describes various marketing strategies including promotional giveaways and Pharma-funded medical education programs.
Industry Payments to Physicians for Opioid Products, 2013-2015
Scott E. Hadland, Maxwell S. Krieger and Brandon D. L. Marshall. American Journal of Public Health, September 2017.
The gist: This study examines payments pharmaceutical companies make to physicians to market opioid products. The authors find that 375,266 opioid-related payments that weren’t related to research work were made to 68,177 physicians over the study period. The authors estimate that about 1 in 12 physicians in the U.S. received a payment from a pharmaceutical company to promote their opioid medications during the 29-month study period. The bulk of the money went toward speaking fees or honoraria, but the most common expense was food and beverages – 352,298 payments totaling $7,872,581.
Association of Pharmaceutical Industry Marketing of Opioid Products to Physicians with Subsequent Opioid Prescribing
Scott E. Hadland, Magdalena Cerdá, Yu Li, Maxwell S. Krieger and Brandon D. L. Marshall. JAMA Internal Medicine, June 2018.
The gist: “Whereas physicians receiving no opioid-related payments had fewer opioid claims in 2015 than in 2014, physicians receiving such payments had more opioid claims,” the authors write.
Physician-level interventions
Differences in Opioid Prescribing Practices among Plastic Surgery Trainees in the United States and Canada
David W. Grant, Hollie A. Power, Linh N. Vuong, Colin W. McInnes, Katherine B. Santosa, Jennifer F. Waljee and Susan E. Mackinnon. Plastic and Reconstructive Surgery, July 2019.
The gist: Plastic surgery trainees were asked about their opioid prescribing education, factors contributing to their prescribing practices and what they would prescribe for eight different procedures. The authors find that, of the 162 respondents, 25% of U.S. plastic surgery trainees received opioid-prescriber education, compared with 53% of Canadian trainees. For all but one of the eight procedures, U.S. physicians prescribed significantly more morphine milligram equivalents than their Canadian counterparts.
Source list
Caleb Alexander, professor and co-director of the Center for Drug Safety and Effectiveness. Johns Hopkins University.
Michael L. Barnett, assistant professor. Harvard T.H. Chan School of Public Health.
Chinazo Cunningham, professor. Albert Einstein College of Medicine.
Scott Hadland, assistant professor. Boston University School of Medicine.
David N. Juurlink, scientist. Sunnybrook Research Institute.
Thomas Kerr, associate professor. The University of British Columbia.
For more, check out JR’s long read on the opioid prescribing problem, our summary of research on where opioids are prescribed the most and our tip sheet for reporting on fentanyl and synthetic opioids.
This piece adheres to suggestions offered by the National Institute on Drug Abuse’s media guide, which recommends language that avoids the potentially stigmatizing term “addict” in the context of substance use. It states: “In the past, people who used drugs were called ‘addicts.’ Current appropriate terms are people who use drugs and drug users.”
*Dropped out of race since publication date.
This article first appeared on Journalist’s Resource on December 9, 2019 and is republished here under a Creative Commons license.
By: Chloe Reichel, Journalist’s Resource
Title: Addressing the Opioid Epidemic: What the Research Says
Sourced From: www.thefix.com/addressing-opioid-epidemic-what-research-says
Published Date: Wed, 22 Jan 2020 07:04:35 +0000
At New Horizon Drug Rehab, we understand addiction. If you or a family member are afflicted with addiction or substance abuse we can help. We work with the top centers throughout the US to provide the best detox and addiction treatments available.
Call Now: (877) 747-9974
New draft alcohol guidelines, released today, recommend healthy Australian women and men drink no more than ten standard drinks a week and no more than four on any one day to reduce their risk of health problems.
This is a change from the previous guidelines, released in 2009, that recommended no more than two standard drinks a day (equating to up to 14 a week).
(If you’re unsure what a standard drink looks like, use this handy reference.)
The guidelines also note that for some people – including teens and women who are pregnant or breastfeeding – not drinking is the safest option.
Read more: Drink, drank, drunk: what happens when we drink alcohol in four short videos
What Are the New Recommendations Based On?
The National Health and Medical Research Council looked at the latest research and did some mathematical modelling to come to these recommendations.
It found the risk of dying from an alcohol-related disease or injury is about one in 100 if you drink no more than ten standard drinks a week and no more than four on any one day.
So, for every 100 people who stay under these limits, one will die from an alcohol-related disease or injury.
This is considered an “acceptable risk”, given drinking alcohol is common and it’s unlikely people will stop drinking altogether. The draft guidelines take into account that, on average, Australian adults have a drink three times a week.
Why Did the Guidelines Need Updating?
Recent research has shown there is a clear link between drinking alcohol and a number of health conditions. These include at least seven cancers (liver, oral cavity, pharyngeal, laryngeal, oesophageal, colorectal, liver and breast cancer in women); diabetes; liver disease; brain impairment; mental health problems; and being overweight or obese.
Some previous research suggested low levels of alcohol might be good for you, but we now know these studies were flawed. Better quality studies have found alcohol does not offer health benefits.
Read more: Health check: is moderate drinking good for me?
The new guidelines are easier to follow than the previous guidelines, which gave recommendations to reduce both short-term harms and longer-term health problems. But some people found these confusing.
Although most Australians drink within the previously recommended limits, one study found one in five adults drank more than the guidelines suggested and almost half could not correctly identify recommended limits.
Although women tend to be more affected by alcohol than men, at the rates of consumption recommended in the guidelines, there is little difference in long term health effects so the guidelines apply to both men and women.
The recommended limits are aimed at healthy men and women, because some people are at higher risks of problems at lower levels of consumption. These include older people, young people, those with a family history of alcohol problems, people who use other drugs at the same time (including illicit drugs and prescribed medication), and those with physical or mental health problems.
The guidelines are currently in draft form, with a public consultation running until February 24.
After that, there will be an expert review of the guidelines and the final guidelines will be released later in 2020. There may be changes to the way the information is presented but the recommended limits are unlikely to change substantially, given they’re based on very careful and detailed analysis of the evidence.
What’s the Risk for People Under 18?
The draft guidelines recommend children and young people under 18 years drink no alcohol, to reduce the risk of injury and other health harms.
The good news is most teenagers don’t drink alcohol. Among 12 to 17 year olds, only 20% have had a drink in the past year and 1.4% drink weekly. The number of teenagers who have never had a drink has increased significantly in the last decade, and young people are having their first drink later.
Read more: Three ways to help your teenage kids develop a healthier relationship with alcohol
However, we know teenagers are more affected by alcohol than adults. This includes effects on their developing brain. We also know the earlier someone starts drinking, the more likely they will experience problems, including dependence.
The idea that if you give teenagers small sips of alcohol it will reduce risk of problems later has now been debunked. Teens that have been given even small amounts of alcohol early are more likely to have problems later.
What’s the Risk for Pregnant and Breastfeeding Women?
The guidelines recommend women who are pregnant, thinking about becoming pregnant or breastfeeding not drink any alcohol, for the safety of their baby.
Read more: Health Check: what are the risks of drinking before you know you’re pregnant?
We now have a much clearer understanding of the impacts of alcohol on the developing foetus. Foetal alcohol spectrum disorder (FASD) is a direct result of foetal exposure to alcohol in the womb. Around one in 67 women who drink while pregnant will deliver a baby with foetal alcohol spectrum disorder.
Foetal alcohol spectrum disorder is characterised by a range of physical, mental, behavioural, and learning disabilities ranging from mild to severe – and is incurable.
Worried About Your Own or Someone Else’s Drinking?
If you enjoy a drink, stick within these recommended maximums to limit the health risks of alcohol.
If you have trouble sticking to these limits, or you are worried about your own or someone else’s drinking, call the National Alcohol and other Drug Hotline on 1800 250 015 to talk through options or check out these resources online.
Read more: Did you look forward to last night’s bottle of wine a bit too much? Ladies, you’re not alone
Nicole Lee, Professor at the National Drug Research Institute (Melbourne), Curtin University
This article is republished from The Conversation under a Creative Commons license. Read the original article.
By: Nicole Lee, Curtin University
Title: Cap Your Alcohol at 10 Drinks a Week: New Draft Guidelines
Sourced From: www.thefix.com/cap-your-alcohol-10-drinks-week-new-draft-guidelines
Published Date: Tue, 21 Jan 2020 06:50:21 +0000
At New Horizon Drug Rehab, we understand addiction. If you or a family member are afflicted with addiction or substance abuse we can help. We work with the top centers throughout the US to provide the best detox and addiction treatments available.
Call Now: (877) 747-9974
Over the past few years, CBD has been heralded as a cure for ailments from arthritis to addiction. But it can be challenging to know what’s rumor and what is scientifically verified fact. That’s why it’s essential to review what real scientific studies say about using CBD to treat certain conditions.
When it comes to addiction, the research shows that CBD is promising. Here’s what you should know about using CBD to treat addiction.
What is CBD?
You’ve probably heard of CBD, but still not understand exactly what it is. CBD, or cannabidiol, is a chemical component found in marijuana or hemp. Unlike THC, it’s not psychoactive, and it’s not thought to be addictive either. CBD can be infused into a variety of products, from oils to bath bombs. People who use it believe it helps treat many conditions, including addiction.
CBD can help people with opioid addiction
Opioids are among the most powerfully addictive substances. CBD can be useful in helping people get off and stay off opioids, research indicates.
For starters, having access to medical marijuana might help people from becoming hooked on opioids in the first place. A 2014 study found that states with medical marijuana programs had significantly lower rates of opioid overdoses. The study did not investigate the cause of this correlation, but it could be that people who were able to treat their pain with cannabis products were less likely to use highly addictive opioids.
Another study indicates that CBD might lessen the appeal of opioids. A 2013 study done on rats founds that rats who were given CBD did not find morphine as rewarding. That suggests that CBD interferes with the way that the brain responds to opioids and could potentially impact the addictive nature of opioids.
Many people who become addicted to opioids are treated using methadone. One 2013 study found that people who were using cannabis while on a methadone treatment plan reported less intense opioids withdrawals.
CBD can help with methamphetamine and cocaine addictions, too
A 2019 scientific review indicated that CBD could be useful for treating cocaine and methamphetamine addiction. The research shows that CBD might help people avoid relapsing on meth or cocaine.
“A limited number of preclinical studies indicate that CBD could have therapeutic properties on cocaine and METH addiction and some preliminary data suggest that CBD may be beneficial in cocaine-crack addiction in humans,” the study authors wrote. “Importantly, a brief treatment of CBD induces a long-lasting prevention of reinstatement of cocaine and METH seeking behaviours.”
This use of CBD is particularly crucial because there are currently no medication-assisted treatments for methamphetamine or cocaine addiction. Opioids can be treated using methadone, buprenorphine, or naltrexone, and this medication-assisted treatment improves outcomes for people with opioid use disorder. However, there’s no similar course of treatment for people struggling with meth or cocaine addiction. Because of that, CBD could be particularly promising for those patients.
CBD could be useful if you’re trying to quit smoking
Many people who are in recovery from substance use disorder still smoke cigarettes. Research shows that CBD could be useful in breaking the addictive pull of nicotine. A 2018 study looked at cigarette smokers who had abstained overnight, after being given a dose of CBD. Researchers found that the CBD didn’t reduce the cravings for nicotine, but it did make the experience of smoking a cigarette the next morning less pleasurable.
An earlier study, published in 2013, showed even more promise. Researchers found that cigarette smokers who took CBD as needed reduced the number of cigarettes they smoked by 40%. The study concluded, “CBD [is] a potential treatment for nicotine addiction that warrants further exploration.”
Is CBD safe for people who have a history of addiction?
CBD is generally considered safe, and it isn’t addictive. It’s key to make sure that you’re getting CBD from a reputable seller so that you can be sure that the CBD you’re taking doesn’t contain THC, the active ingredient in marijuana that can be addictive.
Want to learn more about the science of CBD and addiction? Click here.
By: The Fix staff
Title: Can CBD Help with Addiction? Here’s What the Science Says
Sourced From: www.thefix.com/can-cbd-help-addiction-here-s-what-science-says
Published Date: Mon, 23 Mar 2020 03:16:41 +0000
At New Horizon Drug Rehab, we understand addiction. If you or a family member are afflicted with addiction or substance abuse we can help. We work with the top centers throughout the US to provide the best detox and addiction treatments available.
Call Now: (877) 747-9974
In recovery circles, there is a lot of focus on treatment. Admitting you have a drug or alcohol problem and being willing to seek treatment is a massive step on the journey toward health. Finding the right treatment center that can meet your individual needs can help you create a solid foundation for recovery. Still, the 30, 60 or even 90 days that you spend in treatment are just a drop in the bucket compared to the rest of your life. To really succeed in sobriety, you need to focus on recovery after treatment.
Whether you’ve recently finished treatment or are floundering a bit in early recovery, having a plan for recovery after treatment can help you get on the right track. Here’s what you can do to protect your sobriety after treatment ends.
Have Realistic Expectations
It would be wonderful if people could go to treatment for a set amount of time and emerge entirely cured from their substance use disorder. Unfortunately, that’s not realistic. The past traumas, underlying mental health issues and other factors that contributed to your substance abuse are still with you, even in recovery.
The key difference is that you’re now able to deal with them in healthier ways. You can talk to professionals, go to a meeting, meditate or exercise when you’re overwhelmed, rather than using. Still, you have to accept that sometimes you’re not going to feel great. Life can still be challenging even in recovery, so be prepared for there to be bumps in the road, no matter how transformational your treatment experience was.
Utilize Step-down Programs and Transitional Housing
Many people who go through treatment had their lives interrupted by their addiction. You might have experienced job loss, homelessness or credit challenges. Some people never learned to cope with the challenges of adult life without turning to drugs and alcohol. No matter what, reentering the “real world” after treatment can be daunting.
That’s where step-down programs and transitional housing can help. If you went to an inpatient treatment program, it can be shocking to go from a structured environment to being on your own. To ease that transition, “step down” through treatment options, including outpatient and evening programs. Consider living in transitional housing, where you can pursue a job or education while still having some structure and accountability.
Grow Your Sober Community
After you leave treatment, you might feel a bit lonely. Many of the people that you spent time with during active addiction aren’t safe to be around now that you’re building a sober life. Your friends who didn’t experience addiction might still be hurt by your past actions, or cautious in reestablishing their relationship with you.
Your new sober community can help fill the gaps. Attend meetings, go to alumni events at your treatment center, and make friends with others at your sober living. Although putting yourself out there can be scary, the benefits of having sober friends invested in your success are well worth it.
Focus On The Long Term
When you’re in treatment, your attention is on the next 30 days. However, to stay sober over a lifetime you have to focus on the big picture, one day at a time. You might experience days where you’re coping with cravings. You’ll likely have frustrations that your life isn’t coming together as quickly as you would like. By staying focused on your long-term goal of surviving and thriving in recovery, you can better handle the ups and downs of early recovery.
Staying sober is a lifelong commitment. During early recovery, you can set the foundation for that, by building your community, establishing healthy habits, and learning which practices are most helpful for you. You’ll learn to recognize triggers and how to avoid them. And you will realize the importance of reaching out for help. Over time, all of this will strengthen your sobriety and help you live the life that you want live, without drugs or alcohol.
Learn more about Oceanside Malibu at http://oceansidemalibu.com/. Reach Oceanside Malibu by phone at (866) 738-6550. Find Oceanside Malibu on Facebook.
By: The Fix staff
Title: What Happens After Treatment?
Sourced From: www.thefix.com/what-happens-after-treatment
Published Date: Mon, 20 Jan 2020 06:50:26 +0000
At New Horizon Drug Rehab, we understand addiction. If you or a family member are afflicted with addiction or substance abuse we can help. We work with the top centers throughout the US to provide the best detox and addiction treatments available.
Call Now: (877) 747-9974
