Thursday, March 27, 2008
Thursday, March 20, 2008
Wax on, wax off
OK, if Peter Rost can devote unseemly amounts of column inches to Elliot Spitzer, than I'm going to feel free to wax poetical on the heels of our current financial crisis. The following is an excerpt from a poem I wrote a long time ago, called Who Wants to Play? from the perspective of an investment banker:
Our wages come not from the things we create,
but the miniscule squeezings of this or that rate.
I'll earn more than my father by producing much less.
He worked as a craftsman; I'll learn about stress.
The Fed is our lackey; it works toward our ends.
The families we shred, we demand that they mend.
You won't see it coming, then you'll blame the wrong fools.
You can't change a thing when you play by our rules.
We'll crush you beneath our invisible hand
'Cause you cannot resist what you don't understand.
Cheerful, huh? I was in an uncharitable mood at the time. Unlike today! I also wrote an Ode to the Federal Reserve back then. No, really. If you say pretty please, I may even publish it here.
Our wages come not from the things we create,
but the miniscule squeezings of this or that rate.
I'll earn more than my father by producing much less.
He worked as a craftsman; I'll learn about stress.
The Fed is our lackey; it works toward our ends.
The families we shred, we demand that they mend.
You won't see it coming, then you'll blame the wrong fools.
You can't change a thing when you play by our rules.
We'll crush you beneath our invisible hand
'Cause you cannot resist what you don't understand.
Cheerful, huh? I was in an uncharitable mood at the time. Unlike today! I also wrote an Ode to the Federal Reserve back then. No, really. If you say pretty please, I may even publish it here.
Tuesday, March 18, 2008
Compare & Contrast
I've been doing some fascinating reading about the admissability of adverse event data in a pharmaceutical product liability case. "Post-sale" duty to warn concerns the marketing experience, and the related spontaneous adverse event reports, and accumulation and analysis of data.
The Third Restatement of Torts specifically addresses post-sale failure to warn duty, and states that the duty arises "when new information is brought to the attention of the seller." There's no affirmative duty to continue to test (forgetting for the moment any Phase IV commitments) but the manufacturer is supposed to keep abreast of scientific literature and related developments.
Now, the Federal Register specifically states that ADRs are not conclusive of causality (21 CFR 314.80(a)). In fact, a company "need not admit, and may deny" causality of an individual report (21 CFR 314.80(k)). The FDA has also stated that “[a]ccumulated [AE] cases may not be used to calculate incidences or estimates of drug risk" in a 1996 report. These tidbits have been used by defendants to exclude expert testimony on the incidence of ADRs, and actual ADR reports themselves, which is a shame for the plaintiffs, because they make such fun reading for a jury. There are exceptions, particularly in a Bendectin case which allowed expert testimony in 1985. ADR reports can be used to prove notice, however. A plaintiff could argue that the mere existence of reports indicates that a company had notice of possible issues, and a clever lawyer would refer to a large volume of reports, hoping a jury would assume that a big stack of 3500A reports meant that the drug had problems, even if they don't get to hear about the content.
Anyway, this is all leading to the Baycol litigation, where the defense for Bayer had evidence about "AER data" excluded from consideration. The decision cited the Federal Register, and those FDA reports warning against using ADR data inappropriately. A quote from an affidavit from Dr Janet Arrowsmith-Lowe, formerly with the FDA and CDC: "It is a well accepted pharmaco-epidemiologic principle that the biases affecting AERs preclude their use in calculating rates of events or in comparing rates of adverse events among pharmaceutical products." The court cited her affidavit several times, and accepted her arguments.
But what if a company chooses to use that type of data in their own defense (click link for "Spontaneous Adverse Event Reporting Information...)? If they make the case that post-marketing reports demonstrate the relative safety of their drug, will they later be able to make the claim to exclude such data in litigation?
The Third Restatement of Torts specifically addresses post-sale failure to warn duty, and states that the duty arises "when new information is brought to the attention of the seller." There's no affirmative duty to continue to test (forgetting for the moment any Phase IV commitments) but the manufacturer is supposed to keep abreast of scientific literature and related developments.
Now, the Federal Register specifically states that ADRs are not conclusive of causality (21 CFR 314.80(a)). In fact, a company "need not admit, and may deny" causality of an individual report (21 CFR 314.80(k)). The FDA has also stated that “[a]ccumulated [AE] cases may not be used to calculate incidences or estimates of drug risk" in a 1996 report. These tidbits have been used by defendants to exclude expert testimony on the incidence of ADRs, and actual ADR reports themselves, which is a shame for the plaintiffs, because they make such fun reading for a jury. There are exceptions, particularly in a Bendectin case which allowed expert testimony in 1985. ADR reports can be used to prove notice, however. A plaintiff could argue that the mere existence of reports indicates that a company had notice of possible issues, and a clever lawyer would refer to a large volume of reports, hoping a jury would assume that a big stack of 3500A reports meant that the drug had problems, even if they don't get to hear about the content.
Anyway, this is all leading to the Baycol litigation, where the defense for Bayer had evidence about "AER data" excluded from consideration. The decision cited the Federal Register, and those FDA reports warning against using ADR data inappropriately. A quote from an affidavit from Dr Janet Arrowsmith-Lowe, formerly with the FDA and CDC: "It is a well accepted pharmaco-epidemiologic principle that the biases affecting AERs preclude their use in calculating rates of events or in comparing rates of adverse events among pharmaceutical products." The court cited her affidavit several times, and accepted her arguments.
But what if a company chooses to use that type of data in their own defense (click link for "Spontaneous Adverse Event Reporting Information...)? If they make the case that post-marketing reports demonstrate the relative safety of their drug, will they later be able to make the claim to exclude such data in litigation?
Monday, March 17, 2008
Back to the Eighties weekend....
So, have you seen the advertisements for Yaz, the pill that also has indications for PMDD and acne?
If Yaz fails, and the woman gets pregnant, do they sell a morning-after pill called Erasure?
(Hat tip George H.)
The latest screed
New York Times book review of Melody Petersen's "Our Daily Meds."
If Yaz fails, and the woman gets pregnant, do they sell a morning-after pill called Erasure?
(Hat tip George H.)
The latest screed
New York Times book review of Melody Petersen's "Our Daily Meds."
Tuesday, March 11, 2008
Day One
at the Health Law Institute was OK. Tomorrow looks more promising.
I had lunch with a woman working for a law firm which has some Big Pharma clients. She posed an interesting question to me, and I responded in kind.
Her client was asking about employees who have licenses as practitioners, who need to log some clinical time to keep their licenses. Some of these nurse practitioners are also sales reps, whose pay is structured on how practitioners in their geographic areas prescribe. What should be done about these nurse practitioners, whose prescriptions could theoretically affect their pay? Would this arrangement violate some kind of anti-kickback statute?
Well, Stark is not a consideration, since they are not physicians. But there may be state regs that mimic Stark, but apply to a wider array of prescribers. An obvious recommendation to the client would be to restructure their pay for the period when they are in the clinic. Fascinating question though. I'd love to know what they eventually do.
I posed a question back to my lunch friend. If a clinical nurse educator is hired to address an interest group like an Alzheimers association, and they are required to discuss only the disease state and not their employer's medication, how might they still violate the Pharma code by inappropriate promotion? Well, the answer may lie in the clinical development strategy the company pursues, through line extensions and sNDA applications.
Did you ever compare labels and indications between two or more drugs in the same therapeutic family, which are fundamentally identical in mode of action. Go ahead - look it up with the statins, for example. PB will wait.
OK, you back? The clinical strategy for these compounds has been geared toward creating something unique in their indications that the other compounds haven't got. So, when nurse educator Betty speaks to a bunch of cardiologists about lipid-lowering strategies, and discusses the need for the patient to reach certain benchmarks in their therapy, wouldn't it be convenient if her company's compound happens to be the only one indicated to reach those benchmarks? She never needs to mention the drug name, as long as she pounds the message about the therapeutic end-points repeatedly. Then the sales reps for the attending docs can follow-up with a visit sometime later.
I had lunch with a woman working for a law firm which has some Big Pharma clients. She posed an interesting question to me, and I responded in kind.
Her client was asking about employees who have licenses as practitioners, who need to log some clinical time to keep their licenses. Some of these nurse practitioners are also sales reps, whose pay is structured on how practitioners in their geographic areas prescribe. What should be done about these nurse practitioners, whose prescriptions could theoretically affect their pay? Would this arrangement violate some kind of anti-kickback statute?
Well, Stark is not a consideration, since they are not physicians. But there may be state regs that mimic Stark, but apply to a wider array of prescribers. An obvious recommendation to the client would be to restructure their pay for the period when they are in the clinic. Fascinating question though. I'd love to know what they eventually do.
I posed a question back to my lunch friend. If a clinical nurse educator is hired to address an interest group like an Alzheimers association, and they are required to discuss only the disease state and not their employer's medication, how might they still violate the Pharma code by inappropriate promotion? Well, the answer may lie in the clinical development strategy the company pursues, through line extensions and sNDA applications.
Did you ever compare labels and indications between two or more drugs in the same therapeutic family, which are fundamentally identical in mode of action. Go ahead - look it up with the statins, for example. PB will wait.
OK, you back? The clinical strategy for these compounds has been geared toward creating something unique in their indications that the other compounds haven't got. So, when nurse educator Betty speaks to a bunch of cardiologists about lipid-lowering strategies, and discusses the need for the patient to reach certain benchmarks in their therapy, wouldn't it be convenient if her company's compound happens to be the only one indicated to reach those benchmarks? She never needs to mention the drug name, as long as she pounds the message about the therapeutic end-points repeatedly. Then the sales reps for the attending docs can follow-up with a visit sometime later.
Monday, March 10, 2008
Free pharmaceuticals for everyone!
Industry executives have banded together to announce a program to distribute health-affirming pharmaceuticals for free for every American. According to a press release from the world's most profitable industry, the program is already in place, and Americans have been benefitting by ingesting drugs that will help to lower their blood pressure and cholesterol, relieve pain, and encourage bodily growth(s). The program is being touted for its low price and convenience. The industry is rolling out the program with no charge to patients, and distributing the medications conveniently through drinking water. "We may consider a way to try to charge patients for this largesse in the future," stated one industry insider, who wished to remain anonymous. "It's outrageous that patients can derive a pharmaceutical benefit like this without any remuneration whatsoever. This makes the Canadian problem seem trivial in comparison."
Tuesday, March 04, 2008
Legal fun!
Yeah, I do this stuff 'cause I love it.
Pennsylvania Bar Institute's "Health Law Institute," March 11 & 12, Philadelphia Convention Center.
If you're in the mid-Atlantic area, and there are lots of us Pharma people around here, check out this two-day affair next week if you have the chance. PB will be there, and I wish I had posted this earlier to give you a chance to book ahead. Still, its cheaper than most Pharma conferences. The Health Law Institute is not only Pharma topics, or even mostly. But there's plenty to learn about there, and its much more interesting than the last industry conference you went to, I guarantee.
Give me a holler if you will be attending, especially if you're going because I recommended it. Thanks!
Pennsylvania Bar Institute's "Health Law Institute," March 11 & 12, Philadelphia Convention Center.
If you're in the mid-Atlantic area, and there are lots of us Pharma people around here, check out this two-day affair next week if you have the chance. PB will be there, and I wish I had posted this earlier to give you a chance to book ahead. Still, its cheaper than most Pharma conferences. The Health Law Institute is not only Pharma topics, or even mostly. But there's plenty to learn about there, and its much more interesting than the last industry conference you went to, I guarantee.
Give me a holler if you will be attending, especially if you're going because I recommended it. Thanks!
Sunday, March 02, 2008
Campaign fun!
The Philadelphia Inquirer reports that the race for pharma campaign bucks has now tilted overall to the Democrats. Hillary Clinton leads all comers with $408,000 in contributions, but you won't hear Barack Obama complain too much about that, because he's only about $8000 behind her. John McCain remains as the one candidate who can spout off all he wants about Big Pharma, having collected only $112,000 or so up til now. And spout off he does. Read into the Inky article to get to some of his choicier quotes from the campaign trail. He's up to speed about the Medicaid lawsuits that just returned the first verdict against a pharma company in Alabama and he's no fan of Medicaid Part D, either. He clearly indicates that he wants to introduce more price competition into that program.
Billy Tauzin is quoted, acknowledging the "sea change" in contribution patterns toward the demos, but he doesn't sound phazed by McCain's comments.
Wanna have some fun? Navigate to this page at the Federal Election Commission and type in your company name in the search field. Let's find out if Frank down the hall has made a contribution to anyone! I don't know about you, but my company is always trying to get people to contribute to the company PAC, including inducements like making a contribution to a charity of your choice. It's guaranteed to be voluntary with no retribution, but they've never guaranteed anonymity, because they can't. Give to the company PAC, and your name will appear on this publicly accessible website, same as if you gave to a candidate directly.
Billy Tauzin is quoted, acknowledging the "sea change" in contribution patterns toward the demos, but he doesn't sound phazed by McCain's comments.
Wanna have some fun? Navigate to this page at the Federal Election Commission and type in your company name in the search field. Let's find out if Frank down the hall has made a contribution to anyone! I don't know about you, but my company is always trying to get people to contribute to the company PAC, including inducements like making a contribution to a charity of your choice. It's guaranteed to be voluntary with no retribution, but they've never guaranteed anonymity, because they can't. Give to the company PAC, and your name will appear on this publicly accessible website, same as if you gave to a candidate directly.
Saturday, March 01, 2008
John Roberts - Due Diligence foe?
I have a feeling that Chief Justice John Roberts wouldn't care for aspects of my job any more than I do.
When I heard Nina Totenberg quote Justice Roberts on Wednesday evening: "I don't see what more a corporation can do," he said. "What more can the corporation do other than say 'Here is our policies' and try to implement them?" I recognized a kindred spirit.
Why are we hounding our vendors to send us everything they find regarding adverse events, when no other corporation is? Why are we telling our employees to call in every time they hear Aunt Millie complain about her gout worsening, just because she's been taking our blood pressure drug for 10 years?
Because we have no other ideas on how to get any meaningful safety data, and neither does the FDA. We're using these lame methods to pump up our database with nonsense, to show the FDA what good due diligence we pursue. The high-powered epidemiogist brains at our company and FDA can't imagine a requirement for practitioners to report suspected ADRs, or even serious ADRs, or even FATAL ADRs. No, we're going to depend instead on the screening skills of whoever picks up the phone at our rebate fulfillment centers to recognize when a patient is inadvertantly mentioning something negative, however trivial it may be.
And I think John Roberts doesn't care less if we do all this. We've got our policies, and we're generating lots of meaningless data from them. Big deal. I'd like it if John Roberts or somebody else with influence would require us to stop concerning ourselves with every potential petty interaction with patients, and require us instead to practice real science.
When I heard Nina Totenberg quote Justice Roberts on Wednesday evening: "I don't see what more a corporation can do," he said. "What more can the corporation do other than say 'Here is our policies' and try to implement them?" I recognized a kindred spirit.
Why are we hounding our vendors to send us everything they find regarding adverse events, when no other corporation is? Why are we telling our employees to call in every time they hear Aunt Millie complain about her gout worsening, just because she's been taking our blood pressure drug for 10 years?
Because we have no other ideas on how to get any meaningful safety data, and neither does the FDA. We're using these lame methods to pump up our database with nonsense, to show the FDA what good due diligence we pursue. The high-powered epidemiogist brains at our company and FDA can't imagine a requirement for practitioners to report suspected ADRs, or even serious ADRs, or even FATAL ADRs. No, we're going to depend instead on the screening skills of whoever picks up the phone at our rebate fulfillment centers to recognize when a patient is inadvertantly mentioning something negative, however trivial it may be.
And I think John Roberts doesn't care less if we do all this. We've got our policies, and we're generating lots of meaningless data from them. Big deal. I'd like it if John Roberts or somebody else with influence would require us to stop concerning ourselves with every potential petty interaction with patients, and require us instead to practice real science.
Friday, February 08, 2008
M. Butterfly, a review
The current ************ Theatre Company production of M. Butterfly tells an extraordinary and Tony-award winning story, with amazing visual production values. The backdrops are beautiful segmented rings that take on different emotional hues with every sudden change of lighting. Sometimes, too sudden. A little more subtlety might have improved some of the transitions.
But that's the tone of the entire production from the acting perspective as well. The director's notes in the program state that he is no fan of realism and naturalism, scoffing that he can find that just by looking out his window. So his cast attempts no naturalistic acting, with the partial exception of the character Marc, libidinous friend to our protagonist Rene. Butterfly's falsetto makes no attempt to deceive, especially when paired with a rather prominent eyebrow ridge. And the famous five-minute segment where he changes from kimono to business suit and removes his make-up loses the astonishing impact from the original production. This is all by design, and it turns the play into an intellectual discourse on East and West, male and female, reality and fantasy. The audience is not drawn to the characters emotionally. This reviewer felt nothing as the tragedy unfolded, but perhaps I was able to think more about the points brought up during Rene's overlong soliloquy at the conclusion...
-Excuse me, what are you doing?
I'm writing a review. I went to see a play this evening.
-What does any of this have to do with pharma?
Well, nothing I suppose. I just felt like writing, raising a few points I was thinking about...
-But this isn't the place! Leave your intellectual masturbation at the door.
Screw you, its my blog. I can write whatever I want.
-Not if you want people to read it.
This is psychotic. Who the hell are you?
-How about if I guess what you are. A frustrated pharma employee, a wannabe something else, a jerk with a script half-finished on his flash drive...
Screenplay, thanks. So what?
-Oh, wants to be a movie writer? Lemme guess, the story of your pathetic life, made profound somehow. Maybe you can scab during the strike. Who do you have playing you?
Edward Norton, asshole. (Flips through the playbill) Anyway, look here at the benefactor list. GlaxoSmithKline, Shire, Johnson & Johnson...
-Tenuous my friend. Your point?
Well, maybe I don't have one. Or just that pharma money goes everywhere, supports everything.
-We know that already. But Arts are good.
Yeah, I agree. I mean, I actually paid for these tickets, but we've got VPs on boards of various theatre companies, regional symphonies and so on. I've gotten all kinds of free tickets over the years.
-Stadium boxes?
Yeah, but they're harder to come by. At least for me. The sales and marketing guys use them.
-So, whore you've been, whore you'll be again?
I'm not sure if I'm the whore or the pimp. Or which is worse.
-Sounds like you have no self-respect.
Probably not. Neither does a business willing to pony up $650 million in fines, and claim it was just due to a difference in interpretation of Medicaid rules. Totally innocent, of course.
-Yep.
-So how do we end this?
One fine day...no longer to live with dishonor.
-Let's not do anything hasty....
No. Its too late for haste. Good night, my butterfly.
But that's the tone of the entire production from the acting perspective as well. The director's notes in the program state that he is no fan of realism and naturalism, scoffing that he can find that just by looking out his window. So his cast attempts no naturalistic acting, with the partial exception of the character Marc, libidinous friend to our protagonist Rene. Butterfly's falsetto makes no attempt to deceive, especially when paired with a rather prominent eyebrow ridge. And the famous five-minute segment where he changes from kimono to business suit and removes his make-up loses the astonishing impact from the original production. This is all by design, and it turns the play into an intellectual discourse on East and West, male and female, reality and fantasy. The audience is not drawn to the characters emotionally. This reviewer felt nothing as the tragedy unfolded, but perhaps I was able to think more about the points brought up during Rene's overlong soliloquy at the conclusion...
-Excuse me, what are you doing?
I'm writing a review. I went to see a play this evening.
-What does any of this have to do with pharma?
Well, nothing I suppose. I just felt like writing, raising a few points I was thinking about...
-But this isn't the place! Leave your intellectual masturbation at the door.
Screw you, its my blog. I can write whatever I want.
-Not if you want people to read it.
This is psychotic. Who the hell are you?
-How about if I guess what you are. A frustrated pharma employee, a wannabe something else, a jerk with a script half-finished on his flash drive...
Screenplay, thanks. So what?
-Oh, wants to be a movie writer? Lemme guess, the story of your pathetic life, made profound somehow. Maybe you can scab during the strike. Who do you have playing you?
Edward Norton, asshole. (Flips through the playbill) Anyway, look here at the benefactor list. GlaxoSmithKline, Shire, Johnson & Johnson...
-Tenuous my friend. Your point?
Well, maybe I don't have one. Or just that pharma money goes everywhere, supports everything.
-We know that already. But Arts are good.
Yeah, I agree. I mean, I actually paid for these tickets, but we've got VPs on boards of various theatre companies, regional symphonies and so on. I've gotten all kinds of free tickets over the years.
-Stadium boxes?
Yeah, but they're harder to come by. At least for me. The sales and marketing guys use them.
-So, whore you've been, whore you'll be again?
I'm not sure if I'm the whore or the pimp. Or which is worse.
-Sounds like you have no self-respect.
Probably not. Neither does a business willing to pony up $650 million in fines, and claim it was just due to a difference in interpretation of Medicaid rules. Totally innocent, of course.
-Yep.
-So how do we end this?
One fine day...no longer to live with dishonor.
-Let's not do anything hasty....
No. Its too late for haste. Good night, my butterfly.
Wednesday, January 30, 2008
A question for my new friends
A vendor stopped by the other day, and we had an interesting chat about what they are doing for my company, and any legal issues that might pertain.
You see, they're performing social media monitoring for us, for a number of our products, and for our corporate image in general. They're checking out a number of blogs, using technorati and other blog rating tools (I forgot to ask about blogshares! Pick up your shares of pharmablogger today! Cheap!). They're following product discussions on cancer and psychiatry related patient websites. And they're giving us reports on everything they read.
I thought about one of our products in particular that has two key characteristics that interest me. First, it the subject of massive litigation, and second, it has a large amount of sales for off-label uses. Now, I've previously invoked the Divine Wow in these pages, asking that he guide our sales force to be not advising docs about these off-label uses. So for the moment, let's assume my prayers have been heeded, and we won't be on the wrong end of another Neurontin suit.
Yet our product teams are receiving reports about all of the off-label use of our drug from these vendors, as well as reading accounts such as this Wall Street Journal article about dementia patients, accompanied by warnings from the FDA like this. We also know that we're selling outsize amounts of low-dose tabs of our drug, that would not amount to therapeutic doses for its intended purpose, but are enough for the common off-label use. And then there's the IMS Health data. In short our sales force know what's going on out there.
So with all this knowledge about our product and how it's being used in the real world, how protected are we by simply claiming, however accurately, that we're not actually promoting the off-label use? Or in other words, does all of this awareness impose any duty on us to act, to warn, to advise doctors not to use our product inappropriately?
I posed the question to the vendor, and asked if they are providing any legal advice with their website content reports. That's not their function, it turns out. It should probably be mine, but I'm too tired to do the Lexis search tonight.
Even if I didn't find anything, just imagine the jury impact of the facts above. Our company is raking in billions of sales from a product that has a huge percentage of off-label use, that is inappropriate and harmful and maybe even fatal according to the FDA, and we're very aware that this is taking place, even if we're not instigating it, and we're not doing anything to stop it. How would you rule?
I might also add that we are not the only ones researching ourselves on the net. The plaintiff firms and "natural products" companies are doing it as well, but at least we're not actually posting or steering discussions in the patient forums (fora?). Heartening to know we're at least a half-step more ethical than law firms, isn't it? And of course, all-natural products never harmed anyone, right Socrates?
You see, they're performing social media monitoring for us, for a number of our products, and for our corporate image in general. They're checking out a number of blogs, using technorati and other blog rating tools (I forgot to ask about blogshares! Pick up your shares of pharmablogger today! Cheap!). They're following product discussions on cancer and psychiatry related patient websites. And they're giving us reports on everything they read.
I thought about one of our products in particular that has two key characteristics that interest me. First, it the subject of massive litigation, and second, it has a large amount of sales for off-label uses. Now, I've previously invoked the Divine Wow in these pages, asking that he guide our sales force to be not advising docs about these off-label uses. So for the moment, let's assume my prayers have been heeded, and we won't be on the wrong end of another Neurontin suit.
Yet our product teams are receiving reports about all of the off-label use of our drug from these vendors, as well as reading accounts such as this Wall Street Journal article about dementia patients, accompanied by warnings from the FDA like this. We also know that we're selling outsize amounts of low-dose tabs of our drug, that would not amount to therapeutic doses for its intended purpose, but are enough for the common off-label use. And then there's the IMS Health data. In short our sales force know what's going on out there.
So with all this knowledge about our product and how it's being used in the real world, how protected are we by simply claiming, however accurately, that we're not actually promoting the off-label use? Or in other words, does all of this awareness impose any duty on us to act, to warn, to advise doctors not to use our product inappropriately?
I posed the question to the vendor, and asked if they are providing any legal advice with their website content reports. That's not their function, it turns out. It should probably be mine, but I'm too tired to do the Lexis search tonight.
Even if I didn't find anything, just imagine the jury impact of the facts above. Our company is raking in billions of sales from a product that has a huge percentage of off-label use, that is inappropriate and harmful and maybe even fatal according to the FDA, and we're very aware that this is taking place, even if we're not instigating it, and we're not doing anything to stop it. How would you rule?
I might also add that we are not the only ones researching ourselves on the net. The plaintiff firms and "natural products" companies are doing it as well, but at least we're not actually posting or steering discussions in the patient forums (fora?). Heartening to know we're at least a half-step more ethical than law firms, isn't it? And of course, all-natural products never harmed anyone, right Socrates?
Wednesday, November 21, 2007
Equalizing stem cells
From the reality-based community viewpoint
"The reprogrammed skin cells, by contrast, appear to hold the same properties as embryonic stem cells" according the New York Times.
Presumably, that also includes the ability to grow into a full-fledged human being, if implanted into the proper medium (uterus). Yet theologists such as Richard Doerflinger hailed this advance as the solution to the moral quagmire of embryonic stem cell extraction, which now may not require destruction of an embryo, anyway.
Why is the reformulated skin cell OK to use? If its identical to the stem cell that became my fetus 39 years ago, what makes it OK to experiment on now? Put another way, if I have embryonic stem cell "A" in my left hand, and a re-formulated skin cell "B" in my right, with either having the potential to grow into a human, what makes the one in my left hand holy?
Is it intent? The cell on my left was created by a process of fertilization that was designed to create a new person. Does some kind of "fit-for-purpose" spiritual calculation imbue that cell with a soul upon the biological union of sperm and egg? That immediately makes me think of the 75% of all embryos and fetuses that are naturally disposed of, never destined to develop because of a defect, or because the host mother is unable to house them. They were created with the same intent.
I'm sure Catholicism has an answer for that question, since it's not new, and that's actually something I admire about Catholic scholarship, from Augustine onward - the attempt to use rationality and logic to define spiritual boundaries. Its the convoluted results of that scholarship that leaves Catholics open to scorn from other Christian sects, but at least they try.
"The reprogrammed skin cells, by contrast, appear to hold the same properties as embryonic stem cells" according the New York Times.
Presumably, that also includes the ability to grow into a full-fledged human being, if implanted into the proper medium (uterus). Yet theologists such as Richard Doerflinger hailed this advance as the solution to the moral quagmire of embryonic stem cell extraction, which now may not require destruction of an embryo, anyway.
Why is the reformulated skin cell OK to use? If its identical to the stem cell that became my fetus 39 years ago, what makes it OK to experiment on now? Put another way, if I have embryonic stem cell "A" in my left hand, and a re-formulated skin cell "B" in my right, with either having the potential to grow into a human, what makes the one in my left hand holy?
Is it intent? The cell on my left was created by a process of fertilization that was designed to create a new person. Does some kind of "fit-for-purpose" spiritual calculation imbue that cell with a soul upon the biological union of sperm and egg? That immediately makes me think of the 75% of all embryos and fetuses that are naturally disposed of, never destined to develop because of a defect, or because the host mother is unable to house them. They were created with the same intent.
I'm sure Catholicism has an answer for that question, since it's not new, and that's actually something I admire about Catholic scholarship, from Augustine onward - the attempt to use rationality and logic to define spiritual boundaries. Its the convoluted results of that scholarship that leaves Catholics open to scorn from other Christian sects, but at least they try.
Sunday, September 30, 2007
This is how it went that night.
Since a recent posting concerning the deteriorating health of my mother, there have been further developments. She passed away last month. It is the scene of her final moments that I wish to describe.
I talked about the probably medication errors that brought her to the hospital. Now, we used a different medication to help end her life.
I was called to the hospital by my three siblings, who had been there a while. They wanted to increase her morphine drip, knowing that the increase would likely be the end of her already labored respiration. But they waited for me to arrive first. When I got there, she was on her side, and each breath made her face look like a fish gasping fon land. Her eyes were open, but not seeing. There was no one else in the room. Since my sister is a nurse in that hospital, she could control the rate of the iv drip.
I was rather alarmed. I wanted to better understand what was happening. I know that my sister wanted Mom to be out of pain, but were we killing her?
I spoke up, and asked that question. Everyone was distressed, but we could still have a conversation about what was going on. My sister asked me what I wanted to do, which was difficult to answer. She wasn't being flippant - there she was, in possession of much greater knowledge about the situation than I could hope to have, but she really wanted my opinion. I asked, what was she really dying from - would she be dying anyway, and were we just hastening a process with the morphine, while sparing her pain. She was bleeding internally, and there was no way to access the bleed without invasive surgery, which we had declined to do, since she would not survive the procedure with her co-morbidities.
Sister went ahead and increased the morphine, and within a few minutes, the very loud labored breathing quieted down. Her eyes remained open. I positioned myself seated by her head, my nurse sister to my left. She was talking to Mom constantly, giving reassuring statements which were likely not heard. My other sister and brother were on the other side. Over the course of several minutes, her respiration continued to drop, as well as her heartbeat. Sister mentioned that when her heart rate dripped below 60, her pacemaker would attempt to kick in. It did, creating a short spike on the monitor, but it didn't last. Her vitals continued to drop quickly from there, and then she just stopped all motion. Her eyes remained open, and the rest of the time we were in the room, and we said goodbye, I considered closing her eyes, but did not.
One bizarre moment was yet to occur. We had to get the attending ICU physician to declare her death, so we called the floor nurses to get the doc. It was about 2 am. I watched him stumble toward the room, he walked in, banging his shoulder on the partly open glass door, walked past the four of us, peered over her, turned around and said "well, she's at peace" to nobody in particular. He stumbled out, banging his other shoulder on the same door. No acknowledgement of any of us. Nothing like "Hi, I'm doctor whoever, I'm sorry for your loss.
JMK (nee H) 1928-2007
I talked about the probably medication errors that brought her to the hospital. Now, we used a different medication to help end her life.
I was called to the hospital by my three siblings, who had been there a while. They wanted to increase her morphine drip, knowing that the increase would likely be the end of her already labored respiration. But they waited for me to arrive first. When I got there, she was on her side, and each breath made her face look like a fish gasping fon land. Her eyes were open, but not seeing. There was no one else in the room. Since my sister is a nurse in that hospital, she could control the rate of the iv drip.
I was rather alarmed. I wanted to better understand what was happening. I know that my sister wanted Mom to be out of pain, but were we killing her?
I spoke up, and asked that question. Everyone was distressed, but we could still have a conversation about what was going on. My sister asked me what I wanted to do, which was difficult to answer. She wasn't being flippant - there she was, in possession of much greater knowledge about the situation than I could hope to have, but she really wanted my opinion. I asked, what was she really dying from - would she be dying anyway, and were we just hastening a process with the morphine, while sparing her pain. She was bleeding internally, and there was no way to access the bleed without invasive surgery, which we had declined to do, since she would not survive the procedure with her co-morbidities.
Sister went ahead and increased the morphine, and within a few minutes, the very loud labored breathing quieted down. Her eyes remained open. I positioned myself seated by her head, my nurse sister to my left. She was talking to Mom constantly, giving reassuring statements which were likely not heard. My other sister and brother were on the other side. Over the course of several minutes, her respiration continued to drop, as well as her heartbeat. Sister mentioned that when her heart rate dripped below 60, her pacemaker would attempt to kick in. It did, creating a short spike on the monitor, but it didn't last. Her vitals continued to drop quickly from there, and then she just stopped all motion. Her eyes remained open, and the rest of the time we were in the room, and we said goodbye, I considered closing her eyes, but did not.
One bizarre moment was yet to occur. We had to get the attending ICU physician to declare her death, so we called the floor nurses to get the doc. It was about 2 am. I watched him stumble toward the room, he walked in, banging his shoulder on the partly open glass door, walked past the four of us, peered over her, turned around and said "well, she's at peace" to nobody in particular. He stumbled out, banging his other shoulder on the same door. No acknowledgement of any of us. Nothing like "Hi, I'm doctor whoever, I'm sorry for your loss.
JMK (nee H) 1928-2007
Tuesday, September 25, 2007
Social Media Marketing
A new term for me, courtesy of a vendor who will be carrying out this function for my company within a few weeks. It means blog monitoring, in short, both the posts (like this one) that write about your company or product, as well as the feedback the blog postings generate (like all three of mine). I was aware of activity at my company that scrutinized sites like WebMD and the major disease sites like the various Cancer societies, but now we're talking about a bigger rabbit hole.
We'll be jumping into it headfirst, looking for postings for one of our asthma products. Google and Technorati keyword searches, board tracker software, etc.
An anonymous screen name is not enough to warrant action normally for an adverse event report. That's just not a valid, identifiable patient or reporter. But we've made exceptions in the past if the poster describes a serious adverse event that we have a particular interest in for that product.
I'm a little unsure about the value add for this kind of activity. Last Spring, our pro-active monitoring of Cafe Pharma revealed a very embarrassing post by a named individual in our sales force, that compared physician visits by sales reps to grabbing money from a cookie jar. It still made it to Peter Rost's blog, but we did fast damage control by being aware of it that much sooner. Pharma Blogosphere has information about posing as consumers on blogs, but we've never reached that point, and I doubt we will, considering the scowling glances that our legal folks brought to the table, simply at the mention of monitoring sites.
Recent experience is very interesting. For another, more controversial product, we uncovered artificial blogging activity that was an attempt to create business for law firms. One poster would write "I started taking this medicine, and this terrible thing happened!" and the response would be "That happened to me too! I just got a $100,000 settlement for it though. Check it out!" and the whole thing was an elaborate fake. There would be a banner at the bottom for Dewey, Screwum and Howe law offices. We managed to take action, but my readers will be aware that we were (and still are) awash in legal cases.
Speaking of which, I just participated in a review of a regulatory document for a legally challenged product that was hardly a joy to read, as it was all about patient deaths. As I alluded to in a previous post, there are concerns that the legal case overload will throw off our ability to detect genuine safety signals. If our spontaneous caseload normally equals x% of the background "noise" for a condition or event, but the case load for one particular issue skyrockets and clogs our database, our statistical analysis must be reconfigured to handle that, or else a separate analysis is undertaken to discount those legal cases. The latter is what we've actually done. So for this document, the discussion of legal cases was made separate from the rest.
A special shout-out to those of you who let me know you've added my blog to your Google Reader accounts. Let me know if you got this.
We'll be jumping into it headfirst, looking for postings for one of our asthma products. Google and Technorati keyword searches, board tracker software, etc.
An anonymous screen name is not enough to warrant action normally for an adverse event report. That's just not a valid, identifiable patient or reporter. But we've made exceptions in the past if the poster describes a serious adverse event that we have a particular interest in for that product.
I'm a little unsure about the value add for this kind of activity. Last Spring, our pro-active monitoring of Cafe Pharma revealed a very embarrassing post by a named individual in our sales force, that compared physician visits by sales reps to grabbing money from a cookie jar. It still made it to Peter Rost's blog, but we did fast damage control by being aware of it that much sooner. Pharma Blogosphere has information about posing as consumers on blogs, but we've never reached that point, and I doubt we will, considering the scowling glances that our legal folks brought to the table, simply at the mention of monitoring sites.
Recent experience is very interesting. For another, more controversial product, we uncovered artificial blogging activity that was an attempt to create business for law firms. One poster would write "I started taking this medicine, and this terrible thing happened!" and the response would be "That happened to me too! I just got a $100,000 settlement for it though. Check it out!" and the whole thing was an elaborate fake. There would be a banner at the bottom for Dewey, Screwum and Howe law offices. We managed to take action, but my readers will be aware that we were (and still are) awash in legal cases.
Speaking of which, I just participated in a review of a regulatory document for a legally challenged product that was hardly a joy to read, as it was all about patient deaths. As I alluded to in a previous post, there are concerns that the legal case overload will throw off our ability to detect genuine safety signals. If our spontaneous caseload normally equals x% of the background "noise" for a condition or event, but the case load for one particular issue skyrockets and clogs our database, our statistical analysis must be reconfigured to handle that, or else a separate analysis is undertaken to discount those legal cases. The latter is what we've actually done. So for this document, the discussion of legal cases was made separate from the rest.
A special shout-out to those of you who let me know you've added my blog to your Google Reader accounts. Let me know if you got this.
Friday, July 27, 2007
Reflections in a Glassy Eye
How PB's Personal Life
has been affected by medications is not a new topic. I've mentioned personal issues with my wife's medications, for example. Now the subject is PB's mother, the likely victim of a medication error.
Mom was rehabbing a severe hip problem, when the staff at the residential rehab place gave her an injectable anti-coagulant (not heparin - the name escapes me. Long day.) apparently without discontinuing her Coumadin. They also gave it IM instead of in the gut, where it's indicated. A hemorrhage ensued, accompanied by the usual complications of low hemoglobin, hypoxia, etc. A hospital acquired pneumonia followed.
The hemorrhage was stopped, and Mom recently returned to a different rehab place, to resume treating the underlying mobility problem. I might add that she has unbelievable insurance coverage, thanks to Dad's employment at another Big Pharma company, which ended in 1983. She pays the first $500 out of pocket for anything - docs, meds, whatever, and nothing else after. Not a dime. Can anybody beat that? I can't.
Since being in the new place for a few days, Mom has been "out of it" - glassy eyed, can't find the right words while speaking, and memory loss. This was a very sharp 79 year old woman who was taking college classes last Fall. There are a few different possible reasons for this - her hemorrhage trauma and associated blood problems may have caused some damage to her brain, she has had poor blood oxygen off and on, and her pneumonia continues, but you wouldn't know it without an x-ray. PB also found out about another possible cause - she started Zoloft at about the same time. I need to research possible adverse effects of that SSRI.
Anyway, what drove me to post all this was the reaction I had today from a visit with her.
People visit their elderly parents for a variety of reasons. They are dutiful, the visits are good for the patients, etc. I have a 96 year old in-law who is visited regularly, which is wonderful, but it's not for the sparkling conversation. PB visits Mom because she is an intelligent and interesting conversationalist. Today was very different. It felt like the dutiful visit from the son with all the conversation in one direction, while she stared into the middle distance, smiled and nodded, with no other reply. This was disturbing enough, but when I spoke to staff members about this, they seemed all too eager to dismiss it with simple explanations. It's the meds, or the PT has her tired. Sounds fine, but it's BS. She's been on meds harder than anything you can buy on the street, and was never like this. She's had terrible arthritis for over 30 years which has worn out her body, and was never like this. She wasn't like this two weeks ago. But the staff doesn't know any of that, and frankly, everyone else whom they care for on this floor is in much the same zombie state. So why should they be concerned about the mental condition of a woman they don't know anything about?
As I sat with her during lunch today, I looked around at the 20 or so other residents, and it occurred to me how odd it is that so many people, with nothing else in common besides their age and infirmity, could act so completely identical to each other. What I'm saying is that every one of these people had some kind of personality at one time - there were former jocks, geeks, princesses, whatever, sitting in that room today, and if you subtracted 60 or so years from all of them, that would have been evident. But today they are all identical, with the same stare, no conversation, nothing at all to differentiate them except the color of their clothes.
I've been in a place populated by people in a worse state, who are experiencing dementia, and I noticed that an old personality re-emerges sometimes in that stage. Bullying, crying, and other highly emotional states come flying back to these folks when their minds lose a grip on reality.
But today, my mother was one of the starers, and it scared me to death. This is not who she is. I'm not ready to lose her mind, or to visit her out of a sense of duty. This sounds terribly crass of me, I know. If her brain was indeed damaged, than there may be no recourse. But when she did speak to me, there was fear in her glassy eyes too, because she know exactly what she's lost. She knows she wasn't like this a couple of weeks ago, and she doesn't know if she'll ever get her mind back.
A shout-out to my brother and sisters who live much closer to Mom than I, and have been such excellent advocates for her, especially A____. She's a nurse who is making sure the staff and the doctors know that something is terribly wrong with our mother's mental state, that this is NOT normal, and needs to be investigated, not explained away. I apologize heartily for every time I ever called you a bitch, dear sister.
has been affected by medications is not a new topic. I've mentioned personal issues with my wife's medications, for example. Now the subject is PB's mother, the likely victim of a medication error.
Mom was rehabbing a severe hip problem, when the staff at the residential rehab place gave her an injectable anti-coagulant (not heparin - the name escapes me. Long day.) apparently without discontinuing her Coumadin. They also gave it IM instead of in the gut, where it's indicated. A hemorrhage ensued, accompanied by the usual complications of low hemoglobin, hypoxia, etc. A hospital acquired pneumonia followed.
The hemorrhage was stopped, and Mom recently returned to a different rehab place, to resume treating the underlying mobility problem. I might add that she has unbelievable insurance coverage, thanks to Dad's employment at another Big Pharma company, which ended in 1983. She pays the first $500 out of pocket for anything - docs, meds, whatever, and nothing else after. Not a dime. Can anybody beat that? I can't.
Since being in the new place for a few days, Mom has been "out of it" - glassy eyed, can't find the right words while speaking, and memory loss. This was a very sharp 79 year old woman who was taking college classes last Fall. There are a few different possible reasons for this - her hemorrhage trauma and associated blood problems may have caused some damage to her brain, she has had poor blood oxygen off and on, and her pneumonia continues, but you wouldn't know it without an x-ray. PB also found out about another possible cause - she started Zoloft at about the same time. I need to research possible adverse effects of that SSRI.
Anyway, what drove me to post all this was the reaction I had today from a visit with her.
People visit their elderly parents for a variety of reasons. They are dutiful, the visits are good for the patients, etc. I have a 96 year old in-law who is visited regularly, which is wonderful, but it's not for the sparkling conversation. PB visits Mom because she is an intelligent and interesting conversationalist. Today was very different. It felt like the dutiful visit from the son with all the conversation in one direction, while she stared into the middle distance, smiled and nodded, with no other reply. This was disturbing enough, but when I spoke to staff members about this, they seemed all too eager to dismiss it with simple explanations. It's the meds, or the PT has her tired. Sounds fine, but it's BS. She's been on meds harder than anything you can buy on the street, and was never like this. She's had terrible arthritis for over 30 years which has worn out her body, and was never like this. She wasn't like this two weeks ago. But the staff doesn't know any of that, and frankly, everyone else whom they care for on this floor is in much the same zombie state. So why should they be concerned about the mental condition of a woman they don't know anything about?
As I sat with her during lunch today, I looked around at the 20 or so other residents, and it occurred to me how odd it is that so many people, with nothing else in common besides their age and infirmity, could act so completely identical to each other. What I'm saying is that every one of these people had some kind of personality at one time - there were former jocks, geeks, princesses, whatever, sitting in that room today, and if you subtracted 60 or so years from all of them, that would have been evident. But today they are all identical, with the same stare, no conversation, nothing at all to differentiate them except the color of their clothes.
I've been in a place populated by people in a worse state, who are experiencing dementia, and I noticed that an old personality re-emerges sometimes in that stage. Bullying, crying, and other highly emotional states come flying back to these folks when their minds lose a grip on reality.
But today, my mother was one of the starers, and it scared me to death. This is not who she is. I'm not ready to lose her mind, or to visit her out of a sense of duty. This sounds terribly crass of me, I know. If her brain was indeed damaged, than there may be no recourse. But when she did speak to me, there was fear in her glassy eyes too, because she know exactly what she's lost. She knows she wasn't like this a couple of weeks ago, and she doesn't know if she'll ever get her mind back.
A shout-out to my brother and sisters who live much closer to Mom than I, and have been such excellent advocates for her, especially A____. She's a nurse who is making sure the staff and the doctors know that something is terribly wrong with our mother's mental state, that this is NOT normal, and needs to be investigated, not explained away. I apologize heartily for every time I ever called you a bitch, dear sister.
Sunday, March 25, 2007
Phrase of the Day
PB learned a new phrase today, while catching up on George Will columns - "rent-seeking." OK, I've actually heard it before, without necessarily knowing what it meant, and I'm sure you business school types are scoffing at PB's ignorance.
BTW, note the link on the right from the page above for the Pat Sajak columns. Did you know Pat was a columnist? PB is having an enlightening weekend.
Sound like anyone we know?It is not true that businesses, as a matter of principle, want to fend off government regulation. Businesses have a metabolic urge to make money, which is as it should be. But when a compliant government gives them the opportunity to use government regulations to enhance their moneymaking, that metabolic urge will overpower any principles about the virtues of free (from government intervention) enterprise.
BTW, note the link on the right from the page above for the Pat Sajak columns. Did you know Pat was a columnist? PB is having an enlightening weekend.
Saturday, March 17, 2007
March 15 WSJ
By the way, if you can find a copy, pick up last Thursday's Wall Street Journal to read the front page article on cancer drug pricing. You can read a blurb here, in addition to some reader comments. I was considering commenting, but just about everything was said. I might add to the poster ("JIM") who is concerned about the economics knowledge of WSJ readers - Investigate how long it takes Pharmas to recoup that $1 billion investment. Not too long, folks. And how much of that $1 billion is real, how much is NIH, etc.
Friday, March 16, 2007
Face to face
So, we'll be traveling next week up the turnpike to see counterparts from another Big Pharma, negotiating safety data exchange agreements. Or rather, observing the negotiation. This is PB's first face-to-face with another company. Yes it's true - PB is an underachiever, so to speak. I came into this racket late, after wasting a few years with more menial jobs. Now I'm not a youngster anymore, and I'm feeling it.
Anyway, the big legal issue with licensing for us has to do with reporting timelines, and the EU. Volume 9A, the European Commission's guidance document on pharmacovigilance (PV) was published in late January, and the big hit in licensing has to do with individual case handling reports (ICHRs). Specifically, the guidance explicitly states in Part 1, section 4.2, that the reporting clock date is set at "0" whenever the Marketing Authorisation Holder company or any company with a contractual arrangement with the MAH gets information about a adverse event. Ouch. Up until now, our practice has been to consider Day "0" the day when our company gets the report from our licensing partner. The deadline is day 15 - these are calendar days, not working days. So now we have to factor in much shorter data exchange timelines with other companies, and re-negotiate existing agreements.
Unfortunately, we don't have any electronic data exchange with our licensing partners. Our ability to do this is hampered by a lack of shared/compatible data standards and systems, and strained IT budgets. We're faxing and e-mailing case reports back and forth. We're doing this after the case has been entered into our own system, with our own internal timelines. Those internal guideline are geared toward our own company getting the reports in by day 15, not worrying about another company needing to do the same thing. Really, it's substantially shorter than 15 days already, because we've got to make the reports available to our marketing companies around the world, so they can submit the reports (usually a CIOMS) to their regulators.
So now, we have to decide either 1. Rework our individual case handling procedures to shorten our internal timelines, and expect our licensing partners to do the same, or 2. Assign one or the other of the companies to handle all of the reporting duties of a co-marketed drug to all of the regulators around the world, or 3. Share all source materials about adverse events with our partners the day they are received, and trust each party to send reports to their respective parts of the world's regulators
In reverse order, Number 3 is a non-starter, because our two companies could have completely different opinions on a case, if it's regulatory serious, listed with our core data sheet, etc. Then we would have two versions of the same case submitted to agencies, which would be a legal nightmare. We'd also never be able to produce a PSUR with competing cases.
Number 2 above can work fine if we're dealing with another large Pharma with established international reporting. They can do the case handling, submit the IPARs and QLLs to the Europeans for us, etc. The company I'm visiting next week can most likely do all that. But it gets really ugly when you've done a licensing deal with a company that only covers one country, like the US. If your licensing partner in the US is only selling your drug here, they have no reason to submit anything to European regulators. They may not even have the means to do so. And they probably won't tighten their internal timelines to get ICHRs to us quickly, so that we can.
So, we're often stuck with option 1, which is chaos and scrambling, or making exceptions for this or that product received from this or that source. Forget harmonization of processes. Or, my personal favorite variation on option 1, streamline your processes to cut out review times of ICHRs. Just type the case in and send it. This would put our reviewing physicians in a snit, but too bad. My company has too many reviews on an ICHR anyway. We've done some recent benchmarking, finding that other companies are just sending the reports, and worrying about medical review later.
But we know that *others* (Dr Wolfe, big law firms, David Graham at FDA) are scrutinizing our ICHRs, and our goal is to get the MedWatch exactly accurate before they go out the door the first time, being very careful with our wording. Franky, if you read my last couple of posts, it doesn't seem to be making any difference. We're under siege as it is, regardless of what we submit.
Anyway, the big legal issue with licensing for us has to do with reporting timelines, and the EU. Volume 9A, the European Commission's guidance document on pharmacovigilance (PV) was published in late January, and the big hit in licensing has to do with individual case handling reports (ICHRs). Specifically, the guidance explicitly states in Part 1, section 4.2, that the reporting clock date is set at "0" whenever the Marketing Authorisation Holder company or any company with a contractual arrangement with the MAH gets information about a adverse event. Ouch. Up until now, our practice has been to consider Day "0" the day when our company gets the report from our licensing partner. The deadline is day 15 - these are calendar days, not working days. So now we have to factor in much shorter data exchange timelines with other companies, and re-negotiate existing agreements.
Unfortunately, we don't have any electronic data exchange with our licensing partners. Our ability to do this is hampered by a lack of shared/compatible data standards and systems, and strained IT budgets. We're faxing and e-mailing case reports back and forth. We're doing this after the case has been entered into our own system, with our own internal timelines. Those internal guideline are geared toward our own company getting the reports in by day 15, not worrying about another company needing to do the same thing. Really, it's substantially shorter than 15 days already, because we've got to make the reports available to our marketing companies around the world, so they can submit the reports (usually a CIOMS) to their regulators.
So now, we have to decide either 1. Rework our individual case handling procedures to shorten our internal timelines, and expect our licensing partners to do the same, or 2. Assign one or the other of the companies to handle all of the reporting duties of a co-marketed drug to all of the regulators around the world, or 3. Share all source materials about adverse events with our partners the day they are received, and trust each party to send reports to their respective parts of the world's regulators
In reverse order, Number 3 is a non-starter, because our two companies could have completely different opinions on a case, if it's regulatory serious, listed with our core data sheet, etc. Then we would have two versions of the same case submitted to agencies, which would be a legal nightmare. We'd also never be able to produce a PSUR with competing cases.
Number 2 above can work fine if we're dealing with another large Pharma with established international reporting. They can do the case handling, submit the IPARs and QLLs to the Europeans for us, etc. The company I'm visiting next week can most likely do all that. But it gets really ugly when you've done a licensing deal with a company that only covers one country, like the US. If your licensing partner in the US is only selling your drug here, they have no reason to submit anything to European regulators. They may not even have the means to do so. And they probably won't tighten their internal timelines to get ICHRs to us quickly, so that we can.
So, we're often stuck with option 1, which is chaos and scrambling, or making exceptions for this or that product received from this or that source. Forget harmonization of processes. Or, my personal favorite variation on option 1, streamline your processes to cut out review times of ICHRs. Just type the case in and send it. This would put our reviewing physicians in a snit, but too bad. My company has too many reviews on an ICHR anyway. We've done some recent benchmarking, finding that other companies are just sending the reports, and worrying about medical review later.
But we know that *others* (Dr Wolfe, big law firms, David Graham at FDA) are scrutinizing our ICHRs, and our goal is to get the MedWatch exactly accurate before they go out the door the first time, being very careful with our wording. Franky, if you read my last couple of posts, it doesn't seem to be making any difference. We're under siege as it is, regardless of what we submit.
Sunday, March 11, 2007
Not much. What's new with you?
Legions of readers have been asking, so PB, what's been going on with you?
Well, we're happy to say we've conned ever more people into thinking we're doing a good job at work, and we're looking at a promotion within the next few months. There's cutbacks in other parts of the company, so that means that additional justifications have to be made for promotions, new hiring, etc. Really, that means that delays are built into the process, so we don't look so callous to managers who have to let people go. The company can say with some plausible deniability that they are not blatantly ignoring the company's bottom line by promoting PB when others elsewhere are being shown the door.
So, why are some people out the door? Over capacity created by incorrect forecasts, which were made incorrect by some high-profile late stage trial failures. Big ones. A shame - those were the products that actually made us proud to be in this business. They were innovative science, new approaches to unmet needs, etc. They just didn't work, was all. Details, details....
Well, we're happy to say we've conned ever more people into thinking we're doing a good job at work, and we're looking at a promotion within the next few months. There's cutbacks in other parts of the company, so that means that additional justifications have to be made for promotions, new hiring, etc. Really, that means that delays are built into the process, so we don't look so callous to managers who have to let people go. The company can say with some plausible deniability that they are not blatantly ignoring the company's bottom line by promoting PB when others elsewhere are being shown the door.
So, why are some people out the door? Over capacity created by incorrect forecasts, which were made incorrect by some high-profile late stage trial failures. Big ones. A shame - those were the products that actually made us proud to be in this business. They were innovative science, new approaches to unmet needs, etc. They just didn't work, was all. Details, details....
Legal Assault
Ouch - over 1000 adverse event report in the past week and counting, all submitted by law firms for one product of ours. Our drug safety group has been scrambling to get these cases in the database on time, asking overseas offices to assist in the data entry, working weekends, etc. Deadlines will be met, according to the Veep of the department.
The reports for this particular product have been rolling in for about a year. We've got about 8000 total legal reports with named patients. If you've read Grisham's The King of Torts, then you have some idea about how this works. Now I'm seeing it from the other side.
If you Google the brand name of this product, about 3 or 4 of the top 2o hits are for law firms, but almost all of the Sponsored links are for lawyers. It's also under investigation by Pennsylvania for off-label marketing. This is a huge franchise, and we're counting on line extensions to keep sales up for at least 10 more years. It's a shame that a product becomes more well known for the negative news it generrates than any actual good it has done for patients.
We have little advance warning about when to expect discs arriving from a law firm with hundreds or more cases, but we haven't had to cry uncle yet. Still, the resource drain is huge.
The reports for this particular product have been rolling in for about a year. We've got about 8000 total legal reports with named patients. If you've read Grisham's The King of Torts, then you have some idea about how this works. Now I'm seeing it from the other side.
If you Google the brand name of this product, about 3 or 4 of the top 2o hits are for law firms, but almost all of the Sponsored links are for lawyers. It's also under investigation by Pennsylvania for off-label marketing. This is a huge franchise, and we're counting on line extensions to keep sales up for at least 10 more years. It's a shame that a product becomes more well known for the negative news it generrates than any actual good it has done for patients.
We have little advance warning about when to expect discs arriving from a law firm with hundreds or more cases, but we haven't had to cry uncle yet. Still, the resource drain is huge.
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