A friend of mine on Gilenya sent me this article that her neuro gave her. I found it interesting.....it supports taking one of them no matter what...??
“Fake breakthrough, fake news:’ One physician-researcher’s takeaway on news coverage of MS drug Ocrevus
POSTED BYCATEGORIESbiotech, Business of health, Health care journalism, health care marketing TAGSbiologic drugs, drug industry influence, multiple sclerosis
Joy Victory is deputy managing editor of HealthNewsReview.org. She tweets as @thejoyvictory.
The biggest health news of last week was undoubtedly the FDA approval of Roche’s Ocrevus for a severe form of multiple sclerosis. The New York Times, the Associated Press, CNN, NBC News, Fox News, STAT News, HealthDay, TIME.com, and Reuters–and many others–wrote about the drug, also known as ocrelizumab.
MS drug OcrevusWhen we peeked behind the headlines, though, we detected a major issue widely discussed by MS patients and experts online but not being addressed in the mainstream news coverage: Is Ocrevus any better than its very close cousin, the well-established and cheaper drug Rituxan (rituximab) that is also made by Roche but which now faces price competition from “biosimilars” (the biotech version of generics)? When it comes down to it, in other words, is this more about money and less about a new breakthrough?
Neurologist and research scientist Dr. Annette M. Langer-Gould says yes. When she read about Ocrevus’s approval in major media outlets, she was disappointed and described the reporting as “glowing, unabashed, buy-Roche-stock-now.” She left a comment on the New York Times story stating the drug is nothing more than an “expensive, overdosed version of Rituxan,” and she mentioned the need for more balanced news reporting. We reached out to her for more details.
“It is like free advertising for Roche stock, and this is at the expense of accurately informing the American public,” said Langer-Gould via a phone interview. She holds the titles of Regional Physician Multiple Sclerosis Champion at Kaiser Permanente Southern California, and MS specialist at Los Angeles Medical Center. “It is a fake breakthrough…it’s shameless.”
Langer-Gould speaks from an insider’s perspective: She used to work for Genentech (now owned by Roche) and helped conduct research on these drugs before going back into patient care. She said there is plenty of deliberate manipulation on the part of pharma marketing departments to curry positive media coverage (by crafting fake “breakthroughs,” etc).
There’s no evidence that the media intended to publish misleading Ocrevus news, but due to incomplete reporting, that’s arguably what has happened here. (See more on the problems of fake news and sloppy reporting in “Pollution of health news,” a recent editorial by HealthNewsReview.org publisher Gary Schwitzer published in the BMJ).
So what did Langer-Gould feel was missing–and what would have elevated the news coverage so that it does accurately inform the American public?
Ocrevus’s high dosage alarms Langer-Gould
First, the 600 mg dosage level Ocrevus was approved at was not tested adequately, Langer-Gould said. In her opinion, “it’s way overdosed and may actually be less safe than the way we use rituximab.”
Because of this safety concern, her clinic is not planning to switch their roughly 800 MS patients off Rituxan to Ocrevus. Kaiser Permanente, Langer-Gould’s employer, is one of the few insurance plans in the U.S. that cover Rituxan.
None of the stories we read included experts’ concerns about dosing. But many stories did discuss–at least superficially–the potential for safety problems to emerge now that the drug will presumably be used more widely.
The AP, HealthDay, the Times and STAT News, for example, mentioned the higher risk of tumors in the Ocrevus treatment group, as measured in the drug company-funded study published in the New England Journal of Medicine.
NBC News did the best describing the tumor risk, explaining that “about one-half of one percent of the patients who took the drug developed cancer, which was twice the rate of those who did not take the drug.”
But none mentioned that many MS physicians will likely encourage patients who are on Rituxan to stay on it (if they can get access to it) because of these safety reasons. The New York-based International Multiple Sclerosis Management Practice, for example, issued this statement: “For patients who can obtain Rituximab, it would be safer to continue with this therapy, until with time, we are better able to advise patients about the risks associated with Ocrelizumab.”
Uncritical examination of the $65,000 price tag
Many stories also widely reported that Ocrevus would cost $65,000 a year, a price that the New York Times and several others framed as being virtuous, because it’s 25% less than the competitor, Rebif (interferon beta-1a). This quote from Roche on high drug prices is a prime example:
“We feel that the industry needs to start to reverse this trend, and believe that pricing Ocrevus 25 percent less than the comparator in our trials is an important first step,” the company was quoted as saying in the Times.
Reuters put it more aptly when it said the lower price “undercuts” the competitor. They also mentioned the competition Roche faces from biosimilars, which are generic–and cheaper–versions of these types of drugs.
The $65,000 also is just a starting price, Langer-Gould said, and six months from now they’re likely to raise it, which is a common industry practice.
Additionally, and more importantly, this price ignores the reality that the nearly identical drug Rituxan–the one Langer-Gould uses for her patients and is also used off-label for MS in the European Union–is a little under $10,000 a year (when dosed for MS patients), has a well-known safety profile, and is likely just as effective.
Because Rituxan is approved for use in cancer treatment and a few other autoimmune diseases, but not MS, few Americans with MS have easy access to Rituxan. That’s because Roche chose not to pursue FDA approval for it for that use (a move, some have alleged, intended to sideline an effective drug that was losing its profit potential and replace it with a far more lucrative one).
This means that most insurers don’t cover Rituxan, but will possibly cover the much more costly Ocrevus, adding more financial strain to an already-overburdened healthcare system–making it even harder to afford health insurance.
Roche/Genentech, meanwhile, maintains that its decisions were based on patient care considerations and not profits. “We advanced [Ocrevus]…into late stage development because we believed it had the best potential for efficacy and safety in people with MS, a disease where long-term treatment is warranted,” said Peter Chin, medical director at Genentech, in an interview with Multiple Sclerosis News Today.
Not a ‘significant improvement’ nor a ‘major therapeutic advance’
The Times and STAT’s piece on Ocrevus included statements from sources who hailed the drug approval, calling it a “big deal,” a “significant improvement,” “quite stunning,” and a “major therapeutic advance,” among other accolades.
But those compliments also could be applied to Rituxan, said Langer-Gould, who added that these “major therapeutic advances” actually happened more than a decade ago. But few benefited because Roche delayed Rituxan’s development and then eventually stopped it altogether. It’s misleading to paint Roche and its scientists as heroic now, she said.
“When they stopped Rituxan’s development, it was the main reason I left Genentech,” she said. “I told them ‘you’re just withholding a highly effective treatment for MS patients for another decade’–and that is exactly what happened.”
Questions? Please see more on our comments policy.
Robert Lisak, MDApril 4, 2017 at 1:33 pmThe monoclonals are NOT identical in which part of CD 20 they target, the way they kill B cells, or the degree to which they are ‘humanized ‘. A head to head comparison would be required to compare side effects and efficacy. The question of dose is interesting as we don’t know how low the B cells need to be for optimal therapeutic effect in many non-cancer diseases for rituximab. There is the one study of ofatumumab presented at AAN in Philadelphia a few years ago, with another anti-CD20 monoclonal antibody where the lowest of 3 doses which did not totally deplete peripheral blood B cells seemed to work as well as the higher doses. But that was a phase 2 study of RRMS. We don’t know if a higher dose of any of these monoclonal antibodies might matter with regard to men ingest B cells. Rituximab did not work in PPMS other than a subset of patients. It is possible that ORATORIO treated patients represented some of that same subset but there wasn’t enough power in ORATORIO to definitely prove that theory. Robert P. Lisak, MD, Wayne State University, Past President, Consortium of Multiple Sclerosis CentersNathaniel ZieringApril 4, 2017 at 6:04 pmRixtuan and Ocrevus are not the same medication, the later is a chimera monoclonal antibody made from human and mouse B cells, whereas the former is wholly human monoclonal antibody. They act differently on the immune system. Moreover, the cost for Rituxan is close to the $65,000 tag that Ocrevus is asking, $10,000 would not cover 1/2 of one dose of Rituxan. This article is an extremely one-sided story.
“Fake breakthrough, fake news:’ One physician-researcher’s takeaway on news coverage of MS drug Ocrevus
POSTED BYCATEGORIESbiotech, Business of health, Health care journalism, health care marketing TAGSbiologic drugs, drug industry influence, multiple sclerosis
Joy Victory is deputy managing editor of HealthNewsReview.org. She tweets as @thejoyvictory.
The biggest health news of last week was undoubtedly the FDA approval of Roche’s Ocrevus for a severe form of multiple sclerosis. The New York Times, the Associated Press, CNN, NBC News, Fox News, STAT News, HealthDay, TIME.com, and Reuters–and many others–wrote about the drug, also known as ocrelizumab.
MS drug OcrevusWhen we peeked behind the headlines, though, we detected a major issue widely discussed by MS patients and experts online but not being addressed in the mainstream news coverage: Is Ocrevus any better than its very close cousin, the well-established and cheaper drug Rituxan (rituximab) that is also made by Roche but which now faces price competition from “biosimilars” (the biotech version of generics)? When it comes down to it, in other words, is this more about money and less about a new breakthrough?
Neurologist and research scientist Dr. Annette M. Langer-Gould says yes. When she read about Ocrevus’s approval in major media outlets, she was disappointed and described the reporting as “glowing, unabashed, buy-Roche-stock-now.” She left a comment on the New York Times story stating the drug is nothing more than an “expensive, overdosed version of Rituxan,” and she mentioned the need for more balanced news reporting. We reached out to her for more details.
“It is like free advertising for Roche stock, and this is at the expense of accurately informing the American public,” said Langer-Gould via a phone interview. She holds the titles of Regional Physician Multiple Sclerosis Champion at Kaiser Permanente Southern California, and MS specialist at Los Angeles Medical Center. “It is a fake breakthrough…it’s shameless.”
Langer-Gould speaks from an insider’s perspective: She used to work for Genentech (now owned by Roche) and helped conduct research on these drugs before going back into patient care. She said there is plenty of deliberate manipulation on the part of pharma marketing departments to curry positive media coverage (by crafting fake “breakthroughs,” etc).
There’s no evidence that the media intended to publish misleading Ocrevus news, but due to incomplete reporting, that’s arguably what has happened here. (See more on the problems of fake news and sloppy reporting in “Pollution of health news,” a recent editorial by HealthNewsReview.org publisher Gary Schwitzer published in the BMJ).
So what did Langer-Gould feel was missing–and what would have elevated the news coverage so that it does accurately inform the American public?
Ocrevus’s high dosage alarms Langer-Gould
First, the 600 mg dosage level Ocrevus was approved at was not tested adequately, Langer-Gould said. In her opinion, “it’s way overdosed and may actually be less safe than the way we use rituximab.”
Because of this safety concern, her clinic is not planning to switch their roughly 800 MS patients off Rituxan to Ocrevus. Kaiser Permanente, Langer-Gould’s employer, is one of the few insurance plans in the U.S. that cover Rituxan.
None of the stories we read included experts’ concerns about dosing. But many stories did discuss–at least superficially–the potential for safety problems to emerge now that the drug will presumably be used more widely.
The AP, HealthDay, the Times and STAT News, for example, mentioned the higher risk of tumors in the Ocrevus treatment group, as measured in the drug company-funded study published in the New England Journal of Medicine.
NBC News did the best describing the tumor risk, explaining that “about one-half of one percent of the patients who took the drug developed cancer, which was twice the rate of those who did not take the drug.”
But none mentioned that many MS physicians will likely encourage patients who are on Rituxan to stay on it (if they can get access to it) because of these safety reasons. The New York-based International Multiple Sclerosis Management Practice, for example, issued this statement: “For patients who can obtain Rituximab, it would be safer to continue with this therapy, until with time, we are better able to advise patients about the risks associated with Ocrelizumab.”
Uncritical examination of the $65,000 price tag
Many stories also widely reported that Ocrevus would cost $65,000 a year, a price that the New York Times and several others framed as being virtuous, because it’s 25% less than the competitor, Rebif (interferon beta-1a). This quote from Roche on high drug prices is a prime example:
“We feel that the industry needs to start to reverse this trend, and believe that pricing Ocrevus 25 percent less than the comparator in our trials is an important first step,” the company was quoted as saying in the Times.
Reuters put it more aptly when it said the lower price “undercuts” the competitor. They also mentioned the competition Roche faces from biosimilars, which are generic–and cheaper–versions of these types of drugs.
The $65,000 also is just a starting price, Langer-Gould said, and six months from now they’re likely to raise it, which is a common industry practice.
Additionally, and more importantly, this price ignores the reality that the nearly identical drug Rituxan–the one Langer-Gould uses for her patients and is also used off-label for MS in the European Union–is a little under $10,000 a year (when dosed for MS patients), has a well-known safety profile, and is likely just as effective.
Because Rituxan is approved for use in cancer treatment and a few other autoimmune diseases, but not MS, few Americans with MS have easy access to Rituxan. That’s because Roche chose not to pursue FDA approval for it for that use (a move, some have alleged, intended to sideline an effective drug that was losing its profit potential and replace it with a far more lucrative one).
This means that most insurers don’t cover Rituxan, but will possibly cover the much more costly Ocrevus, adding more financial strain to an already-overburdened healthcare system–making it even harder to afford health insurance.
Roche/Genentech, meanwhile, maintains that its decisions were based on patient care considerations and not profits. “We advanced [Ocrevus]…into late stage development because we believed it had the best potential for efficacy and safety in people with MS, a disease where long-term treatment is warranted,” said Peter Chin, medical director at Genentech, in an interview with Multiple Sclerosis News Today.
Not a ‘significant improvement’ nor a ‘major therapeutic advance’
The Times and STAT’s piece on Ocrevus included statements from sources who hailed the drug approval, calling it a “big deal,” a “significant improvement,” “quite stunning,” and a “major therapeutic advance,” among other accolades.
But those compliments also could be applied to Rituxan, said Langer-Gould, who added that these “major therapeutic advances” actually happened more than a decade ago. But few benefited because Roche delayed Rituxan’s development and then eventually stopped it altogether. It’s misleading to paint Roche and its scientists as heroic now, she said.
“When they stopped Rituxan’s development, it was the main reason I left Genentech,” she said. “I told them ‘you’re just withholding a highly effective treatment for MS patients for another decade’–and that is exactly what happened.”
Questions? Please see more on our comments policy.
Robert Lisak, MDApril 4, 2017 at 1:33 pmThe monoclonals are NOT identical in which part of CD 20 they target, the way they kill B cells, or the degree to which they are ‘humanized ‘. A head to head comparison would be required to compare side effects and efficacy. The question of dose is interesting as we don’t know how low the B cells need to be for optimal therapeutic effect in many non-cancer diseases for rituximab. There is the one study of ofatumumab presented at AAN in Philadelphia a few years ago, with another anti-CD20 monoclonal antibody where the lowest of 3 doses which did not totally deplete peripheral blood B cells seemed to work as well as the higher doses. But that was a phase 2 study of RRMS. We don’t know if a higher dose of any of these monoclonal antibodies might matter with regard to men ingest B cells. Rituximab did not work in PPMS other than a subset of patients. It is possible that ORATORIO treated patients represented some of that same subset but there wasn’t enough power in ORATORIO to definitely prove that theory. Robert P. Lisak, MD, Wayne State University, Past President, Consortium of Multiple Sclerosis CentersNathaniel ZieringApril 4, 2017 at 6:04 pmRixtuan and Ocrevus are not the same medication, the later is a chimera monoclonal antibody made from human and mouse B cells, whereas the former is wholly human monoclonal antibody. They act differently on the immune system. Moreover, the cost for Rituxan is close to the $65,000 tag that Ocrevus is asking, $10,000 would not cover 1/2 of one dose of Rituxan. This article is an extremely one-sided story.
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