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Friday, June 7, 2019

Proton center set to open in New York

New York’s first proton-therapy center will open today in East Harlem, more than a decade after some of the city’s largest healthcare institutions began planning it.
The New York Proton Center, which cost $300 million to build, will start patient consultations later this month, with cancer treatments expected to begin in July, said Dr. Charles Simone, the center’s chief medical officer.
The 140,000-square-foot facility on East 126th Street between Third and Second avenues is the result of a partnership between Memorial Sloan Kettering Cancer Center, Montefiore Health System and Mount Sinai Health System. ProHealth Proton Management, an affiliate of Lake Success–based medical group ProHealth, will manage the site.
The center’s radiation therapy will use protons, which can be more precisely targeted to treat solid tumors in sensitive areas than traditional photon radiation therapy, which is more likely to damage healthy tissue.
“With proton therapy, the normal tissue gets a lot less radiation, and patients are less likely to experience side effects and complications from radiation,” Simone said. He noted that all forms of radiation can cause fatigue, and patients could experience side effects related to the part of the body part being treated, such as nausea in patients with stomach cancer.
What’s still unclear is how the center will affect treatment costs. While Simone couldn’t say what prices would be agreed to at the East Harlem center, he noted that other facilities typically charge insurers more than for traditional radiation therapy.
The center is working to reach contracts with private insurers, while Medicare has approved coverage for all cancer types, Simone said. It is also in discussions with the state Medicaid program.
“We’re starting to talk with medical directors of several major private insurance companies in the region to get contracts in place and determine which types of patients will be approved for proton therapy,” he said.
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Midlife Diabetes Hikes Odds for Stroke Years Later

In a finding that further confirms the link between type 2 diabetes and stroke, a new study shows that having the blood sugar disease during middle age may boost your risk of having the most common type of stroke later in life.
In addition to a 30% greater chance of an ischemic stroke, the researchers also found that people who had type 2 diabetes in their 40s or 50s were twice as likely to have narrower blood vessels in their brain in their 60s and beyond.
“Our findings highlight the need for controlling midlife type 2 diabetes mellitus to help prevent [ischemic stroke and narrowing of the blood vessels in the brain],” said study author Rongrong Yang. Yang is a Ph.D. candidate at Tianjin Medical University in China.
An ischemic stroke, which is the more common type of stroke, is caused by a blockage in a blood vessel in the brain. This damages the area of the brain that’s no longer receiving enough blood. The less common type of stroke is known as a hemorrhagic stroke. That type of stroke occurs when a blood vessel bursts, causing blood to leak into the brain and cause swelling and tissue damage, the National Stroke Association says.
Type 2 diabetes has long been associated with the risk of stroke, but it’s been hard to know if an increased risk of stroke comes from the diabetes or from other genetic and environmental factors, according to background information in the study.
To better tease out if diabetes itself was a likely culprit, the researchers reviewed data from the Swedish Twin Registry. More than 33,000 twin individuals met the criteria for the study.
The study participants were all born before 1958. None had evidence of narrowed brain blood vessels or stroke before age 60.
Just under 4% of the group had diabetes in midlife. More than 9% had late-life (after 60) strokes or narrowed blood vessels in their brain, the study authors said.
After adjusting the data to account for other stroke risk factors, such as smoking and obesity, the researchers noted the increased risk of ischemic stroke, but didn’t find an increased risk of hemorrhagic stroke.
Yang said that genetic and environmental factors didn’t appear to account for the increased risk of ischemic stroke, but noted that more research needs to be done. This study wasn’t designed to prove a cause-and-effect relationship.
So why might diabetes lead to more ischemic strokes?
“The mechanisms underlying the association of type 2 diabetes mellitus with stroke are complex and not completely understood,” Yang said. But, people with type 2 diabetes have abnormal cholesterol levels and that might contribute to the narrowed blood vessels in the brain.
Dr. Joel Zonszein, director of the clinical diabetes center at Montefiore Medical Center in New York City, said the Swedish population has significantly less type 2 diabetes than would be found in the United States.
Zonszein was not, however, surprised to see a higher risk of stroke and narrowed blood vessels in people with diabetes.
“We need to be much more alert to getting the proper diagnosis of diabetes and controlling risk factors. Focus on the things we can change to try to improve risk factors,” Zonszein said.
“Smoking cessation is important, and we have to treat high blood pressure. High blood pressure puts people at high risk of stroke. People with diabetes should be on a statin to control cholesterol levels, and they should be on the proper medications to control their diabetes,” he added.
Study author Yang agreed that controlling risk factors is key.
“Diabetic patients need to maintain a healthy lifestyle, such as doing regular exercise, eating a healthy diet, keeping a healthy weight, no smoking, as well as [blood sugar] control, in order to reduce the risk of [stroke] in late life,” Yang said.
The findings were published June 5 in Diabetologia.
More information
To learn more about diabetes and stroke, visit the American Diabetes Association.
SOURCES: Rongrong Yang, Ph.D. candidate, department of epidemiology and biostatistics, School of Public Health, Tianjin Medical University, China; Joel Zonszein, M.D., director, clinical diabetes center, Montefiore Medical Center, New York City; June 5, 2019, Diabetologia
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Teva Launches Generic of Ranexa ranolazine Angina Tablets US

Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) announced the launch of a generic version of Ranexa®1 (ranolazine) Extended-Release Tablets, 500 mg and 1000 mg, in the U.S.
Ranolazine Extended-Release Tablets are indicated for the treatment of chronic angina.
With nearly 500 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in eight generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
Ranolazine Extended-Release Tablets has annual sales of nearly $938 million in the U.S., according to IQVIA data as of February 2019. About Ranolazine Extended-Release Tablets Ranolazine Extended-Release Tablets are indicated for the treatment of chronic angina. Ranolazine Extended-Release Tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. IMPORTANT SAFETY INFORMATION Ranolazine Extended-Release Tablets are contraindicated in patients taking strong inhibitors of CYP3A; patients taking inducers of CYP3A; and patients with liver cirrhosis.
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bluebird bio : To Webcast Data Review, ZYNTEGLO Approval

bluebird bio (Nasdaq: BLUE) announced that the company will host a live webcast to review new data presented at the European Hematology Association (EHA) Annual Meeting, and to discuss the approval of ZYNTEGLO® (autologous CD34+ cells encoding βA-T87Q-globin gene) on Friday, June 14 at 8:00 a.m. ET.
Investors may listen to the call by dialing (844) 825-4408 from locations in the United States or +1 (315) 625-3227 from outside the United States. Please refer to conference ID number 2189283.
To access the live webcast of bluebird bio’s presentation, please visit the “Events & Presentations” page within the Investors & Media section of the bluebird bio website at http://investor.bluebirdbio.com. Replays of the webcast will be available on the bluebird bio website for 90 days following the event.
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Psychiatrists’ Acceptance of Medicaid Patients Remains Low

Medicaid expansion hasn’t led to improved access to office-based mental healthcare. On the contrary, a new trends analysis shows declines in psychiatrists’ participation in Medicaid.
“Owing to declines in psychiatrist participation in Medicaid, patient gains in insurance coverage under Medicaid expansion may not translate into meaningful improvements in access to office-based treatment by psychiatrists,” the investigators write.
The data are concerning, first author Hefei Wen, PhD, assistant professor, Department of Health Management and Policy, University of Kentucky College of Public Health, Lexington, told Medscape Medical News.
“Medicaid expansion can only effectively improve access to care for the newly enrolled where there are physicians willing to accept Medicaid patients. Our findings amplify concerns over significant deficits in access to mental health services for low-income and other vulnerable populations, even when they have Medicaid coverage,” said Wen.
The study was published online June 5 in JAMA Psychiatry.

Chief Payer

Medicaid is the chief payer for behavioral health services in the United States and has been expected to play an increasing role in financing behavioral health services with Medicaid expansion. Yet little is known about recent trends in psychiatrists’ acceptance of Medicaid, both before and after 2014, when most Medicaid expansions under the Affordable Care Act (ACA) went into effect.
To investigate, Wen and colleagues analyzed data from 2010–2015 from the National Ambulatory Medical Care Survey (NAMCS), a nationally representative survey of physicians who were not federally employed, were based in offices, and were primarily engaged in direct patient care.
They compared differences in trends in physician acceptance of new Medicaid patients for psychiatrists, primary care physicians (PCPs), and other nonpsychiatric specialists during three 2-year periods, 2010–2011, 2012–2013, and 2014–2015.
During the study periods, 11,521 NAMCS respondents (95% of the total sample) reported seeing new patients. These respondents included 584 psychiatrists, 4400 PCPs, and 6537 other specialists.
During each period examined, psychiatrists were less likely than PCPs and other specialists to accept new patients with Medicaid. Also, there was a significant decline in the likelihood of psychiatrists accepting new Medicaid patients. No significant change in Medicaid acceptance was found among PCPs or other specialists.
ACCEPTING NEW MEDICAID PATIENTS2010–20112012–20132014–2015
Psychiatrists47.9%44.9%35.4%
PCPs75.8%71.7%71.3%
Other specialists77.0%73.2%73.3%
The authors say the adjusted difference-in-differences estimates suggest Medicaid expansion has not been associated with a discernible change in the likelihood of accepting new Medicaid patients among psychiatrists or PCPs but has been associated with an increase in Medicaid acceptance among other specialists.

Need for Better Incentives

Commenting on the analysis, Sandra Decker, PhD, a senior fellow from the Agency for Healthcare Research and Quality, Rockville, Maryland, said, “It is fairly well known that not too many psychiatrists accept Medicaid (or other insurance for that matter). Not sure I completely understand why ACA might be expected to affect that, but I guess it never hurts to draw attention to the fact that acceptance of Medicaid among psychiatrists is low.”
Wen said policy makers may need to identify strategies that will “incentivize psychiatrists to participate in Medicaid, which may be critical for translating expanded coverage into meaningful improvements in access to mental health services.”
One promising approach, she said, may be to encourage care coordination, such as collaborative chronic care models (CCMs), in mental health services.
“CCMs rely on primary care physicians to provide mental health services, with support from case managers and consultation from psychiatrists and other behavioral health specialists. Such models make more efficient use of psychiatrists’ time by allowing psychiatrists to assist primary care teams with expert input and decision support while allocating direct care hours to patients with the most complex psychiatric care needs,” said Wen.
Additionally, the ACA’s provision regarding state innovation models promotes state initiatives such as Medicaid health homes, which may facilitate the development of team-based stepped-care approaches such as CCMs and help address the overall shortage and declining Medicaid participation of psychiatrists, said Wen.
The study received no specific funding. Wen and Decker have disclosed no relevant financial relationships.
JAMA Psychiatry. Published online June 5, 2019. Abstract
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‘Scary World’ of Generic Drug Manufacturing

In 2008, investigative journalist Katherine Eban started digging into the generic drug industry after hearing stories of patients whose generic drugs were not working properly for them. They had been stable on a branded drug, but then relapsed once switched to a generic version or experienced troubling side effects when switched between generics. She detailed her findings in a series of articles in the magazines Self and Fortune, and her new book, Bottle of Lies .
Katherine Eban. Robert Falck
The majority of generic drugs are manufactured overseas, and “the [US Food and Drug Administration] FDA was essentially regulating on an honor system,” Eban told Medscape Medical News. The agency would announce its inspections of overseas manufacturing plants weeks or months in advance, giving companies an opportunity to prepare to put on a good face and mislead inspectors with fabricated data.
In the course of Eban’s reporting, she obtained 20,000 internal FDA documents that “revealed that the FDA’s investigators have grave doubts about the quality of the drugs being manufactured at these plants,” she said. But FDA officials minimized the investigators’ findings.
Eban spoke with Medscape Medical News about the implications of her findings for clinicians. The following is a lightly edited account of the conversation.
Medscape Medical News: What do you think doctors and other healthcare professionals need to know about the state of generic drugs?
Katherine Eban: In the book I feature several doctors from the Cleveland Clinic who struggled with this question of the quality of generics. A number of heart transplant patients suffered organ rejection after being switched to a generic tacrolimus. And also a number of patients who were followed by a cardiologist who became very intently focused on this question and felt he couldn’t stabilize them on certain generics.
He actually identified drugs that were particularly problematic, and after he identified them, lo and behold, the FDA went into the plants, found egregious conditions, and those drugs were recalled. So he was observing something that really is going on.
What I think physicians need to understand is, if their patient is not responding as anticipated from a medication, they need to consider the possibility that it is the medication that is the problem. So instead of just increasing a dose, or switching a patient to a different therapy altogether, I think they need to consider, is this the manufacturer of this generic? Is there a better generic that I can get the patient switched to? Or do I need to make a case to the patient’s insurance company that they should be on the brand? And it’s just a kind of category of thought that physicians need to have.
What role did physicians play in helping these issues come to light?
The doctors that I’ve talked to who have become aware of this, and have petitioned the FDA about this, I think [they] played a major role in having this come to light.
I think without their clinical vigilance, I’m not sure it ever would have come to light. But it’s no accident that it took me essentially 10 years of reporting to produce this book. It’s very complicated. And it requires a lot of connecting of the dots, from clinical symptoms, to the global drug supply, to regulatory failures, to what’s actually happening in these manufacturing plants. It’s a lot of data points to line up. And I think that’s one of the reasons why it hasn’t really come to light before this.
What discovery from your reporting for this book surprised you the most?
The level of data fabrication is really extraordinary. I’ll give you an example.
Because of some of the findings in the plants, the FDA ran a pilot program in India, from 2014 to mid-2015. They decided all the inspections were going to be unannounced or on very short notice, which obviously should be the standard. Once they started going into these plants completely unannounced, what they discovered was just staggering.
The plants operate data fabrication teams that come in in advance of FDA inspections. They alter data, they invent documents, they even invent standard operating procedures that don’t exist. One plant steamed them overnight to make the documents look old. They found out another plant was completely fabricating its testing to prove that the plant was sterile. There were no tests. The laboratory that was doing this was testing nothing, and all their data were perfect. So that’s an example of the kind of depth and extent of the fraud in these plants. It’s shocking.
Is there anything that doctors can do to help their patients avoid these poor-quality generic drugs?
Once doctors become aware of this issue, as their patients have symptoms, or as they have difficulty, I think [doctors] will find that there are certain manufacturers where they have repeated problems, and then when they switch to different manufacturers, everything is OK.
As difficult as it sounds, I think that doctors really have to get to know some of these manufacturers. I think the medical community and the patient community have taken it pretty much on faith from the FDA that all the drugs are interchangeable. That you can just switch from one brand to a generic or between generics and it’s all the same, except that’s really not the case. Once doctors become aware of that, I believe you’re going to find that drugs from certain companies are pretty reliable, and drugs from other companies are not, and that becomes a way to get to the bottom of this more quickly.
What is the role of listening to patients about their reactions after switching to a new generic drug?
Listening to patients is absolutely vital. In the first article I wrote about this, I interviewed this woman who was switched at the pharmacy from a brand name to a generic antidepressant, and had just a horrible set of reactions and side effects. [She] ended up going from doctor to doctor to try to treat all those side effects because she didn’t realize that it was her generic. She finally went online and began doing her own research and began to connect the dots and realize that the onset of her symptoms was at the point that she was switched to a new medication. She called her doctor’s office and the nurse at the doctor’s office said, “Yeah, we hear this from a lot of patients.” Had she had that information previously, she would not have been on this horrible medical odyssey.
Doctors can play a huge role in helping patients with this. Frankly, we need new legislation around this, but that’s not going to happen anytime soon, most likely. So until these problems can get addressed, doctors are really the front line in dealing with it.
What about the role of pharmacists?
My impression is that most pharmacists don’t really know about these issues, and that they also don’t really know where drugs are manufactured. It’s not their fault. What they know is what they have on the shelf at any given time, which is in these big bottles that they’re filling prescriptions from. I think a lot of states don’t even require pharmacies to maintain records of which manufacturer they dispense. The recalls often don’t even get down to the patient level because of that.
To the extent that they talk to consumers, I think [pharmacists] can play a key role in helping them. For example, there are manufacturers whose drugs I won’t take. And my pharmacist knows that I’m a bit of a pain when I go to fill a prescription, but there are just certain companies — because I know that they fabricated data, that their plants are not sterile, that they’ve gotten FDA warning letters — I won’t take a prescription filled with their medicines. And my pharmacist knows that. They let me switch to a different manufacturer. I often am requesting specific generic manufacturers that I trust more than others. But I think if the pharmacist doesn’t understand these issues, that’s going to seem like very strange behavior to them. So it’s something I think that they need to be educated about, too.
One thing that I know a lot of experts in this space really think is important is putting the country of origin, of manufacturing, on dispensing labels. Why shouldn’t consumers know where the active ingredient and the finished drug are made? Why isn’t that information passed along to patients? That is something that could be a sort of educational tool for everybody in this space.
In addition to your book, what are some other key resources to keep up to date on what’s happening with generic drugs at the FDA and which manufacturers have an issue?
On the FDA website there are links to warning letters and import alerts. There’s another site that I like a lot called FDAzilla, which has all of the documents related to FDA inspections on it. If your patient is reacting badly to a drug made by company X, you could go into FDAzilla and look up the inspection record of that company. But for busy physicians, it’s not so easy.
The category of findings related to falsification is called data integrity. The whole idea behind “good manufacturing practices” is that you can’t test the quality of a million pills in a batch. So consequently, good manufacturing requires a kind of minute-by-minute creation of data that accompanies each step of the manufacturing practice. And that data is considered the cornerstone of good manufacturing practices. Without that data, there’s no way to vouch for a drug’s quality. If a company has data-integrity issues, it’s a pretty scary world. It means that there is a real possibility that they’re committing fraud. Not a guarantee, because you can have data-integrity findings that are not necessarily fraud, but negligence, or just problems, but it’s kind of a red flag. And that’s something for doctors to be aware of.
Doctors who are inclined to be political about this should contact their lawmakers. Because it’s really a very difficult, almost intolerable situation that we’re in. I think there needs to be medical activism on this issue.
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Thursday, June 6, 2019

Opioid Overdose Now Provides 1 in 6 Donor Hearts

Hearts from overdose-death donors represent a growing proportion of transplants and appear to do as well as organs from other sources, a retrospective study found.
Overdose-death donors have accounted for a rapidly growing proportion of cardiac allografts, with a 14-fold increase from about 1% in 2000 to now 16.9%, “consistent with the rising opioid epidemic,” reported Nader Moazami, MD, of New York University Langone Health in New York City, and colleagues in The Annals of Thoracic Surgery.
Notably, in many states, overdose-death donors comprised over 25% of cardiac allograft donors in 2018, with a high of 50% in Delaware, they wrote.
While there have been concerns regarding allograft function and infectious risk, the researchers noted overall survival was the same between recipients of overdose-death and non-overdose-death donor organs (P=0.066).
Discard analysis of donors who had at least one organ transplanted but not the cardiac allograft showed overdose-death donor hearts (7.4% of all discards) were:
  • Less likely to be discarded due to being in a diseased organ condition than those donors who died of other causes (28.2% vs 36.1%; P<0.001)
  • More likely deemed higher risk by Public Health Services (63.3% vs 13.2%; P<0.001)
  • More likely to be hepatitis C positive (30.8% vs 5.3%; P<0.001)
“Survival outcomes of recipients of hearts that come from donors that have died from opioid overdose are equivalent to ones that we have traditionally been using, and because of this we believe that there are more donors out there that can be utilized,” Moazami told MedPage Today.
This investigation provides additional information demonstrating that these are good quality organs, agreed Mary Keebler, MD, of the University of Pittsburgh Medical Center, who was not involved in the study. “It adds on to prior literature showing that the outcome with organs from these higher risk donors are just as good as in our donor pool from lower risk donors. It also highlights really nicely just the number of potential donors that we could be using that we aren’t using to get our patients transplanted,” Keebler told MedPage Today.
“These are younger donors, their hearts are arguably better quality than some of the non-opioid related death donors that we are using. So I think that we as a field just need to strongly consider using these organs to help our patients, because there’s really very little downside at this point,” Keebler said.
Moazami’s group evaluated 14,194 non-overdose-death donor and 1,710 overdose-death donor heart transplantations using data from the Scientific Registry of Transplant Recipients. The overdose-death donor cohort less frequently needed inotropic support at procurement (38.4% vs 44.8%), was more likely to be hepatitis C positive (1.3% vs 0.2%), was more often younger than age 40 (87.2% vs 70.1%), and had higher rates of substance abuse.
Cardiac allografts implanted as part of multi-organ transplantation and those from donors with undocumented mechanisms of death were excluded.
Limitations of the investigation included selection bias when assessing cardiac allograft quality and assessment of the broader population of discarded overdose-death hearts was not completed.
“Additionally, although mortality and graft survival were similar between overdose-death donor and non-overdose-death donor groups, long-term infectious implications of using these ‘high-risk’ organs remains to be thoroughly elucidated,” the researchers highlighted.
There will likely be increased use of cardiac allografts from hepatitis C-positive donors, who are otherwise considered healthy, the investigators indicated.
“We have used those organs successfully because now we have treatment for hepatitis C. Even though we know that the recipient is going to develop a hepatitis C viremia, we know that we can treat them effectively and still use the heart,” Moazami emphasized.
“Further research will likely strengthen the argument that current discard criteria for overdose-death donor organs is too stringent, and greater use of these organs may help mitigate the tragedy of the opioid overdose epidemic,” the investigators concluded.
Keebler reported no disclosures.
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