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FDA says Vertex overstates benefits of HCV drug
FDA says Vertex promotional material overstates benefits of hepatitis C drug
By Robert Weisman
Globe Staff
May 31, 2012
Federal regulators have asked Vertex Pharmaceuticals Inc. not to disseminate promotional material they say overstates the benefits of the company’s hepatitis C drug.
In a letter sent last Friday, officials from the Food and Drug Administration's Office of Prescription Drug Promotion said a Vertex-submitted “branded story” from a patient treated with the drug Incivek “is misleading because it overstates the efficacy, omits material facts, and minimizes important risk information about the drug product.”
The letter marked the second setback for the Cambridge biotechnology company in the past week. It was issued the same day Vertex officials said they learned that encouraging clinical trial data they published earlier in the month about the company’s experimental cystic fibrosis treatment had been overstated because of a statistical vendor’s mistake.
That error boosted Vertex shares by more than 55 percent on May 7, enabling five senior executives and two directors to exercise stock options and sell shares worth millions of dollars. After Vertex stock tumbled Tuesday — when the company said the cystic fibrosis data was not as positive as initially reported — shares rallied Wednesday, climbing $2.38, or 4.1 percent, to $60.18 on the Nasdaq stock exchange.
Vertex spokeswoman Nikki Levy said Wednesday that the branded story prepared by the company for the hepatitis C drug, Incivek, has never been distributed, and the company is now reevaluating the material in light of the FDA’s letter, which fell short of a formal warning.
Biopharmaceutical companies are required to submit proposed promotional material to the FDA office for review.
“We take the FDA’s feedback very seriously,” Levy said. “The material they’re referencing hadn’t been used publicly. And it won’t be until we’ve addressed the FDA’s concerns.”
The story, which identifies the patient only as “James ‘J.P.’ M, Hepatitis C Mentor,” was planned as part of a promotional event that is common practice at Vertex and other drug companies.
During such events, patients share their experiences with a treatment, appearing with nurses who also discuss the therapy with prospective new patients.
The patient speakers are paid travel expenses and a modest honorarium by the drug company, Levy said.
In the Vertex patient’s story, which is posted on the FDA’s website, he says: “Six months after the treatment ended, I found out I’d cleared the virus. That made me feel so good. I was happy to know I’d be around a little longer to see my son grow up.”
FDA regulatory review officials Sheetal Patel and Michael Sauers wrote that, while such claims may accurately reflect the patient’s experience, “this branded story misleadingly implies that most or all [patients] infected with hepatitis C will successfully achieve sustained virologic response” on Incivek.
They also said the word “cleared” wrongly implies the removal of the virus from the body.
See: http://tinyurl.com/7a3xy4t
By Robert Weisman
Globe Staff
May 31, 2012
Federal regulators have asked Vertex Pharmaceuticals Inc. not to disseminate promotional material they say overstates the benefits of the company’s hepatitis C drug.
In a letter sent last Friday, officials from the Food and Drug Administration's Office of Prescription Drug Promotion said a Vertex-submitted “branded story” from a patient treated with the drug Incivek “is misleading because it overstates the efficacy, omits material facts, and minimizes important risk information about the drug product.”
The letter marked the second setback for the Cambridge biotechnology company in the past week. It was issued the same day Vertex officials said they learned that encouraging clinical trial data they published earlier in the month about the company’s experimental cystic fibrosis treatment had been overstated because of a statistical vendor’s mistake.
That error boosted Vertex shares by more than 55 percent on May 7, enabling five senior executives and two directors to exercise stock options and sell shares worth millions of dollars. After Vertex stock tumbled Tuesday — when the company said the cystic fibrosis data was not as positive as initially reported — shares rallied Wednesday, climbing $2.38, or 4.1 percent, to $60.18 on the Nasdaq stock exchange.
Vertex spokeswoman Nikki Levy said Wednesday that the branded story prepared by the company for the hepatitis C drug, Incivek, has never been distributed, and the company is now reevaluating the material in light of the FDA’s letter, which fell short of a formal warning.
Biopharmaceutical companies are required to submit proposed promotional material to the FDA office for review.
“We take the FDA’s feedback very seriously,” Levy said. “The material they’re referencing hadn’t been used publicly. And it won’t be until we’ve addressed the FDA’s concerns.”
The story, which identifies the patient only as “James ‘J.P.’ M, Hepatitis C Mentor,” was planned as part of a promotional event that is common practice at Vertex and other drug companies.
During such events, patients share their experiences with a treatment, appearing with nurses who also discuss the therapy with prospective new patients.
The patient speakers are paid travel expenses and a modest honorarium by the drug company, Levy said.
In the Vertex patient’s story, which is posted on the FDA’s website, he says: “Six months after the treatment ended, I found out I’d cleared the virus. That made me feel so good. I was happy to know I’d be around a little longer to see my son grow up.”
FDA regulatory review officials Sheetal Patel and Michael Sauers wrote that, while such claims may accurately reflect the patient’s experience, “this branded story misleadingly implies that most or all [patients] infected with hepatitis C will successfully achieve sustained virologic response” on Incivek.
They also said the word “cleared” wrongly implies the removal of the virus from the body.
See: http://tinyurl.com/7a3xy4t
I read the testimonial and I see the issue. He was a non responder who is cirrhotic. Vertex did present it like it was a panacea -- and non responders are the most difficult to treat with the PIs - add cirrhotics to the mix and wham. I can understand the concern. This was not a typical case
I recently started looking into growing my own vegetables etc the more I learn about what we take and eat is scarey!
Mike, I had missed this whole thing, so I appreciate your posting it. I think if the FDA is coming in and slapping hands, there must be justification. It may give false hope especially to cirrhotics.
I was especially surprised to read in the article that they had overstated the benefit of the new Cystic Fibrosis drugs in the last trial data. In fact, that one floored me. They better start paying attention.
I was one of those investors who bought Vertex when the FDA approved Telaprevir. The stock never shot up. In fact, over time it dropped $20 per share even though their sales were fantastic. I could not understand that as there may be as many as 3-4,000,000 infected in the US alone. Then, when the cystic fibrosis drug was approved (or maybe it was just submitted) the stock went through the roof. But what I didn't understand was how it would rise so high when only 30,000 people were infected in the US (70,000 worldwide). I have decided that it is because the treatment for Hep C is a one-time treatment whereas perhaps the CF patients will have to take this medicine every day for the rest of their lives.
I think everything equates to money. I am appalled at the profit the officers at Vertex made.
bean
I was especially surprised to read in the article that they had overstated the benefit of the new Cystic Fibrosis drugs in the last trial data. In fact, that one floored me. They better start paying attention.
I was one of those investors who bought Vertex when the FDA approved Telaprevir. The stock never shot up. In fact, over time it dropped $20 per share even though their sales were fantastic. I could not understand that as there may be as many as 3-4,000,000 infected in the US alone. Then, when the cystic fibrosis drug was approved (or maybe it was just submitted) the stock went through the roof. But what I didn't understand was how it would rise so high when only 30,000 people were infected in the US (70,000 worldwide). I have decided that it is because the treatment for Hep C is a one-time treatment whereas perhaps the CF patients will have to take this medicine every day for the rest of their lives.
I think everything equates to money. I am appalled at the profit the officers at Vertex made.
bean
"And the best one (my wife loves this ) is if you wear the right feminine products you can ride a horse swim and climb mountains all in the same day infering you can do this because you wear their product? "
Wait a minute, that's not true? I'm so bummed...
Wait a minute, that's not true? I'm so bummed...
By then there will be other treatments out and Incivik will be a has been. Look at Shuring Plough, maker of peg intron. I was on waiting list 10 years ago for 3 months because they couldn't make it fast enough. Did the stock rise, no, I watched it and it didn't hardly budge. Did the drug work? yep, I cleared. No I am relapsed and on Incivik and read an article on Vertex when the drug first came ut (market watch article) Some analyst did a proforma on the number of people infected times the cost (income) and showed millions in income. Reality, My insurance paid for 1/2 the cost and Vertex paid the other 1/2 (well almost they paid 1/2 less a $20 copay. Anyway, the company was supposed to bank some significant cheddar but had to give a lot back in promotion and due to competition. Short story, glad I didn't invest in either but they are good products. Pharmacuticals are having their financial issues right now and will continue to.
I think one of the keys in understanding the principle is that the testimonial was about a stage 3 cirrhotic (possibly) past null responder.
The general aggregate of null responders had a 6X higher cure rate than with SOC.
But....
look at the results of cirrhotic null responders on triple therapy versus those on SOC; (14% versus 10% respectively)
http://www.natap.org/2011/HCV/110211_01.htm
There was only a 4 percent response difference, that is approaching statistically insignificant. I have to wonder what kinds of numbers of patients were used to get that and if it could be skewed due to a small number being tested, but one gets the general idea.
Anyway.... I just wanted to pass on the concept that perhaps wasn't clear to me in the first article posted.
willy
The general aggregate of null responders had a 6X higher cure rate than with SOC.
But....
look at the results of cirrhotic null responders on triple therapy versus those on SOC; (14% versus 10% respectively)
http://www.natap.org/2011/HCV/110211_01.htm
There was only a 4 percent response difference, that is approaching statistically insignificant. I have to wonder what kinds of numbers of patients were used to get that and if it could be skewed due to a small number being tested, but one gets the general idea.
Anyway.... I just wanted to pass on the concept that perhaps wasn't clear to me in the first article posted.
willy
"...They also said the word “cleared” wrongly implies the removal of the virus from the body. ..."
I was intrigued by this statement. I know the eradication issue is subject to debate but I sure didn't expect the FDA to come down on the side that the virus is not removed from the body. In fact, I can't recall reading the word "removal" in an HCV treatment setting. It's not really being removed in a successful treatment as much as it is being destroyed.
My doctor said come right in and I'll remove that nasty virus from your body.
I was intrigued by this statement. I know the eradication issue is subject to debate but I sure didn't expect the FDA to come down on the side that the virus is not removed from the body. In fact, I can't recall reading the word "removal" in an HCV treatment setting. It's not really being removed in a successful treatment as much as it is being destroyed.
My doctor said come right in and I'll remove that nasty virus from your body.
Thank you for posting this Mike.
I too would prefer to see the actual Vertex testimonial in question to decide.
On TV we are hit with actors with scripted stories. How is this worse than that?
It seems to me that viral clearance is a concept and term that I've seen in studies and scientific presentations. It also seems that some viral RNA may linger in many people post TX, but without further damage to the liver and without continuing to replicate and form viral loads. Is this a sticky nomenclature thing rather than an attempt to fool people?
There is little question that the "cure" rate (oops; maybe that word should also be banned)...... I mean the SVR rate has nearly doubled from a few years back. That seems like a good thing, or that some people can now be cured who could not be cured with the SOC (RBV & IFN)
Meanwhile look at the food additives and food practices that are
GRS;"generally regarded as safe".
I'm sure that we will see more specifics about this, but I was underwhelmed, although I am glad that someone is watching. The watchers just don't seem to be seeing far more blatant abuses as near as I can tell.
One other benefit of the new triple therapies is that exposure to SOC is further reduced; another good thing.
Further.....we are seeing that anemia can as easily be treated during TX with RBV reductions without much effect in success rates. This means that one need not rely, or have less reliance upon transfusions and rescue drugs with their own black box warnings. This seems like yet another notable benefit. : /
===================
one final comment. from Mike's post'
"“this branded story misleadingly implies that most or all [patients] infected with hepatitis C will successfully achieve sustained virologic response” on Incivek."
========================
Dude....... when I was diagnosed w/ HCV in 2003...... the success rates for genotype 1's hovered at about 45%.
They are now at minimum at 70% and they could be 80% for all I know. that means that "most" ARE cured. The article seems to have a problem with Vertex claiming that MOST can be cured, when in fact, this is a true statement.
For me that sentence is chock full of WTF. I must be missing something. : /
best,
Willy
I too would prefer to see the actual Vertex testimonial in question to decide.
On TV we are hit with actors with scripted stories. How is this worse than that?
It seems to me that viral clearance is a concept and term that I've seen in studies and scientific presentations. It also seems that some viral RNA may linger in many people post TX, but without further damage to the liver and without continuing to replicate and form viral loads. Is this a sticky nomenclature thing rather than an attempt to fool people?
There is little question that the "cure" rate (oops; maybe that word should also be banned)...... I mean the SVR rate has nearly doubled from a few years back. That seems like a good thing, or that some people can now be cured who could not be cured with the SOC (RBV & IFN)
Meanwhile look at the food additives and food practices that are
GRS;"generally regarded as safe".
I'm sure that we will see more specifics about this, but I was underwhelmed, although I am glad that someone is watching. The watchers just don't seem to be seeing far more blatant abuses as near as I can tell.
One other benefit of the new triple therapies is that exposure to SOC is further reduced; another good thing.
Further.....we are seeing that anemia can as easily be treated during TX with RBV reductions without much effect in success rates. This means that one need not rely, or have less reliance upon transfusions and rescue drugs with their own black box warnings. This seems like yet another notable benefit. : /
===================
one final comment. from Mike's post'
"“this branded story misleadingly implies that most or all [patients] infected with hepatitis C will successfully achieve sustained virologic response” on Incivek."
========================
Dude....... when I was diagnosed w/ HCV in 2003...... the success rates for genotype 1's hovered at about 45%.
They are now at minimum at 70% and they could be 80% for all I know. that means that "most" ARE cured. The article seems to have a problem with Vertex claiming that MOST can be cured, when in fact, this is a true statement.
For me that sentence is chock full of WTF. I must be missing something. : /
best,
Willy
Thx. Mike .
The FDA send Vertex a letter stating basically "stop stating falsehoods about your drug? (by omissions) ?
I am certainly not one to defend "big pharma", as we all know like any business venture their main goal is to make profit,however to jump on Vertex in this case seems a bit heavy handed.
The letter states that they have a probelm with this guys story. Well ..it was his story. he had cirrhosis and as a previous non responder SVR'd and the rash "was nothing" for him..
Not sure I see a problem. Did it infer that everyone is cured . Personally I didn't get that impression.
They say he minimized the rash ?. When the FDA approved Inci they made Vertex put in their prescribing that 22% more patients got a "moderate rash when adding Inci. and that only <1% got serious problems with rash (either DRESS or SJ syndrome) .That to me infers it was not a major problem for most
It seems this fellow stated what happens " to most."
They say Vertex misrepresented that "chirrotic nulls" will all be cleared. No where in his story did he say he was a "null' they say he was a prev. non -responder . Was he a relapser or a partitial ?.
The facts by data are that in these two situations "actually most" did SVR in trial as he states was the case for him.
Also ,if the FDA is going to slam Vertex for saying that the inference was that "most cleared well how DO you decipher 14 to 95 % with much closer to the latter in "most " cases.
Also what about all the ridiculous ads we are bombarded with continuously on TV everday about what all the toxic meds prescribed today can do for us..?
You got some guy skipping through the park ..with music playing saying "now he can watch his grandkids grow up because he is taking statins. They leave out the part about how many die from heart disease ..statins or not .and their are dozens more implied ads
And the best one (my wife loves this ) is if you wear the right feminine products you can ride a horse swim and climb mountains all in the same day infering you can do this because you wear their product?
So ...I think a liitle heavy handed by the FDA on this one .. The prescribing literature spells it all out in great detail ..like all drugs..they are sometimes dangerous and don't always work , risk vs benefit always is the important fact..
It is the doctors that need to know exactly what the drug can and can't do and if the FDA spent even half their time giving letters out to prescribing clinicians on proper care taking these strong meds we would ALL be better off ..IMO
Just my cent ...
Will
The FDA send Vertex a letter stating basically "stop stating falsehoods about your drug? (by omissions) ?
I am certainly not one to defend "big pharma", as we all know like any business venture their main goal is to make profit,however to jump on Vertex in this case seems a bit heavy handed.
The letter states that they have a probelm with this guys story. Well ..it was his story. he had cirrhosis and as a previous non responder SVR'd and the rash "was nothing" for him..
Not sure I see a problem. Did it infer that everyone is cured . Personally I didn't get that impression.
They say he minimized the rash ?. When the FDA approved Inci they made Vertex put in their prescribing that 22% more patients got a "moderate rash when adding Inci. and that only <1% got serious problems with rash (either DRESS or SJ syndrome) .That to me infers it was not a major problem for most
It seems this fellow stated what happens " to most."
They say Vertex misrepresented that "chirrotic nulls" will all be cleared. No where in his story did he say he was a "null' they say he was a prev. non -responder . Was he a relapser or a partitial ?.
The facts by data are that in these two situations "actually most" did SVR in trial as he states was the case for him.
Also ,if the FDA is going to slam Vertex for saying that the inference was that "most cleared well how DO you decipher 14 to 95 % with much closer to the latter in "most " cases.
Also what about all the ridiculous ads we are bombarded with continuously on TV everday about what all the toxic meds prescribed today can do for us..?
You got some guy skipping through the park ..with music playing saying "now he can watch his grandkids grow up because he is taking statins. They leave out the part about how many die from heart disease ..statins or not .and their are dozens more implied ads
And the best one (my wife loves this ) is if you wear the right feminine products you can ride a horse swim and climb mountains all in the same day infering you can do this because you wear their product?
So ...I think a liitle heavy handed by the FDA on this one .. The prescribing literature spells it all out in great detail ..like all drugs..they are sometimes dangerous and don't always work , risk vs benefit always is the important fact..
It is the doctors that need to know exactly what the drug can and can't do and if the FDA spent even half their time giving letters out to prescribing clinicians on proper care taking these strong meds we would ALL be better off ..IMO
Just my cent ...
Will
RE: Vertex-submitted “branded story” from a patient treated with the drug Incivek is not allowed to be disseminated because it “is misleading because it overstates the efficacy, omits material facts, and minimizes important risk information about the drug product.”
________________________--
I would be interested to hear the "branded story" even though it is promotional.
We have all been around long enough to read between the lines. Plus many of us are taking (or have taken) Incivek so it would be easy to see just how over the top the person's story is. I am just curious though. I have a feeling the FDA may be right on this one even though I have not heard the story.
It never occurred to me how the term "cleared the virus" could be taken to imply eradicated it to one who is not familiar with HCV. I actually use the term quite often.
________________________--
I would be interested to hear the "branded story" even though it is promotional.
We have all been around long enough to read between the lines. Plus many of us are taking (or have taken) Incivek so it would be easy to see just how over the top the person's story is. I am just curious though. I have a feeling the FDA may be right on this one even though I have not heard the story.
It never occurred to me how the term "cleared the virus" could be taken to imply eradicated it to one who is not familiar with HCV. I actually use the term quite often.
Hi thank you for this info, I am confused by the last statement about "clearing" does this mean they are saying we don't clear it when we get to SVR? Sorry if this is a dumb question, just curious
Thank you
Thank you
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