Pharmalot: I'm wondering whether you were aghast at all of the marketing pitches and ploys back when you were still working at the Times. And if so, how'd that affect your view of the industry? Petersen: When I began covering the industry in early 2000, I believed the drug companies were all about science. But after following the industry and talking to executives, I saw that my early impression was wrong. For example, that year, some of the most talked-about drugs were products like Nexium, Advair, and Clarinex. The companies said these were “new” drugs. They weren’t. They were little more than old drugs, tweaked a little in the lab and then heavily promoted to make the public believe they were new. I realized that it wasn’t science that drove these companies. It was marketing.
Pharmalot: What do/did you say to people who complain the media is too critical of big pharma and harps on negatives - such as marketing gaffes or side effect reports - and overlooks the positive contributions made by research? Petersen: I know the pharmaceutical industry likes to blame the media for its problems. Unfortunately, the industry gives journalists a lot to write about. The industry sells products that can help people and save lives, but that hardly gives it the right to hurt other people through aggressive marketing.
Pharmalot: Now, to the book: You describe a system that, basically, ran amok and is rigged. How did we get to this point? Petersen: The simple answer comes down to the piles of cash the industry has to spend. Our medical system once had many safeguards to protect patients from drugs they didn’t need. Academics and universities once helped keep the industry’s clinical trials objective and honest. Physicians once were independent from the industry and acted as gatekeepers who put patients first. The FDA once did not require fees from the industry to fund its operations; it’s only client was the public. But all these groups are now dependent on the industry’s cash handouts and patients have suffered. The safeguards have disappeared. The drug companies have learned they can sell just about any pill by spending heavily on promotion. There are relatively few independent experts left who are willing to point out how the system has gone wildly wrong.
Pharmalot: Is there any going back? How can pharma survive without heavily relying on the marketing machine? Petersen: The industry needs to get back to the hard work of using science to discover genuinely new medicines that help the sick and ease suffering. In fact, it’s hard to see a need for companies that don’t do that.
Pharmalot: You suggest several changes in behavior and regulation, such as rolling back DTC advertising to pre-97 constraints. Basically, you're saying DTC hasn't worked. Isn't that like throwing the baby out with the bath water? Some people insist they're more aware of their health because of those ads. Petersen: The television ads have made people believe that all they have to do is swallow a pill and life will be grand. They’ve warped the public’s view about health. I have a lot of gripes with the ads. That said, I actually think the ads are less damaging than all the other promotion the industry does from behind the scenes. I’m talking about the promotion that is disguised to look like its coming from an independent source. Things like the hiring of celebrities and doctors to talk up the benefits of drugs and the creation of medical journal articles that have been ghostwritten by marketers. That is the stuff that is especially dangerous because people don’t have their guard up like they do with advertising. I wrote the book because I wanted people to be able to see through this covert promotion.
Pharmalot: Another suggestion involves requiring docs to provide patients with lists of their interactions with, and ties to, drugmakers. Why is that realistic? Petersen: I actually want a law that bans companies from giving cash or gifts to physicians, while also making it illegal for physicians to take anything from the industry. That’s what we really need. At a minimum, doctors should be required to keep track of everything they receive from the industry and give this list to every patient checking in with the receptionist. By law, political candidates must keep track of all donations and gifts. If doctors want to take corporate handouts, they should have to do the same type of recordkeeping and disclose the list to their patients.
Pharmalot: Do you see any differences now in big pharma's collective behavior than you did while researching the book? If so, how? Petersen: You’re kidding, right? If anything, the marketing has become more aggressive as some of the industry’s big-selling blockbuster drugs have lost their patent protection.
Pharmalot: Drugmakers have a new mantra - transparency - such as posting clinical trials. In your view, is this for real or is it just talk? Petersen: Last year, President Bush signed a law aimed at increasing penalties for companies that don’t quickly disclose clinical data. I hope that will help. But even if the companies now began disclosing all information, we will never learn about the results of an untold number of older clinical studies that have never been published even though they involve drugs still being prescribed.
Pharmalot: Of the various anecdotes about people you wrote about in your book, which moved you the most, and why? Petersen: All the stories in my book about patients who died or were hurt by prescription drugs are heartbreaking. Pharmalot: Which anecdote involving a drugmaker angered you the most, and why? Petersen: It’s hard not to be angry about any case where aggressive marketing harms patients and takes lives. I write about so many of these needless tragedies. It’s impossible to say that one of these cases was somehow more or less egregious than another.
174 Comments
She is right, if the Pharma industry thinks media is being too harsh, they (we) have ourselves to blame.
Unfortunately many patients still find it hard to believe that they are being essentially "sold out" by the very people who are supposed to be helping them - their doctors.
We've done much harm to humanity and we really need to fix it.
Brent Hoadley, author of "Too Profitable to Cure," pointed out many of the same things. Because it was framed from the viewpoint of a T1 diabetic, it appeared to be only about diabetes. NOT! I have not yet read Melody Petersen's book . . . but if it achieves notoriety and effectively disseminates the message that 'profits above patients' is the ruling paradigm, she should be heartily commended.
Could Melody be persuaded to also take a look at the other parts of the health care industry in the US? I am no defender of the excessive practices of the pharma industry, but devices, diagnostics, hospitals are all in the business of maximizing profit through practices that are not well publicized and result in substantial increases in the cost of the system. Pharma is the very public end of a health care funding system that has the patient firmly at the bottom of the list of priorities.
Melody's book is now added to about a dozen others written by pharma critics. And they are all worth reading, for educational purposes, if nothing else.
Great interview. I'm glad that you brought this book to our attention. I wonder if there is a Top 10 List for Big Pharma books worth reading. This one sounds like it would be quite good. I'm sure she's not the first and she probably won't be the last, but she is absolute spot-on with her assessments and suggestions. I applaud the elimination of DTC - let the doctors decide. I'm in favor of cutting the ties between physicians and Big Pharma - the large amount of money that changes hands for the purpose of influencing prescribing is obscene. The opinion leaders also need to become objective in their positions - not heavily subjective because one company is lining their pockets more than the others. Also, eliminate PhARMA - nothing but a bunch of overpaid lobbyists run by a bunch of over-zealous marketers. If Big Pharma doesn't change on its' own, it will be changed by the government. The graft can't continue unabated. It has gone on fro way too long. It's time to put patients first!
Well - I have to say that the VAST majority of those of us that worked in Drug discovery hated marketing.
Oops - wasn't finished there... At any rate - They determined what projects we worked on as well as what technologies we sometimes invested in. It has always been about return on investment to shareholders in the industry. Nothing different about it compared to building cars or making pizza's. To expect that management is going to be altruistic when faced with shareholder expectations is laughable. There was once a rumored scathing memo written by a PD VP in R&D about the fact that since the company wouldn't invest in biotechnology at the time, perhaps they should start making pizza's and compete with another notable company up the street. This was over 18 years ago I think.
I don't know if I can bear to read her book, as through several years of work and study following the killing of my son by Zyprexa, I've learned most everything. I have also made close friends with others who lost their children or their spouses through the antipsychotics or SSRIs. Seldom do our stories hit the papers or books due to confidentiality constraints or feelings on the family's part that the painful death is family business; private. I know these people and their stories, and greatly value their friendship. I'm not sure I want to know any more. Most news articles and blogs talk about share prices or government suits, not death.
Here-in lies the biggest paradox in the industry - the desire to research and develop meaningful products, and the legal responsibility that management has to make a profit. Yes, it is a legal responsibility in public companies that they make profit unless the share holders have given them permission not to. The same is true of the insurance companies (although they don't have the R&D justification that pharma and biotech have).
A core argument in support of this approach has always been that Government is very bad at managing innovation and that the innovation coming from the pharma industry will be aimed at diseases that require treatment and for which a commercial price can be paid. The big problems appear to have arisen in recent years when pharma is perceived to be gouging prices, promoting clinically less relevant "lifestyle" drugs, failing to develop real innovation (and lying about safety when they do). There are many examples of fabulous innovation, reasonable pricing, social awareness and the like. Unfortunately the examples of the "bad" have shifted perceptions too far for the "good" to provide a balance.
Same tune, different singer. She and her ilk who rip the pharma industry would be screaming to the high heavens if they couldn't get the latest and greatest in meds. RTW, you and I agree--the pharma industry is no different than pizza delivery in that they are both in it to make a profit. As it should be--I don't want a non-profit or the gov't developing my medications.
It is ridiculous that she wants the same restrictions on doctors that are on elected officials. Doctors are private practitioners, not politicians. They should be bound by the same rules as lawyers, office workers, and fast food employees are. If I get a gift basket from a vendor, or sports tickets from a potential partner, should I be required to document it, or worse, return it?
Why do we expect doctors and healthcare companies to act like charities? Not only is it unrealistic, it would be counter-productive. The profit motive is excellent for stimulating new developments, increasing efficiency, and boosting customer service.
Melody is proof that a little knowledge is a dangerous thing.
James,
"Doctors are practicing Physicians, not Politicians"
Maybe not,.. But they sure enjoy the perks that come along with Lobbying our Politicians on behalf of Industry..
So what? So does every other company and individual who has a special interest in Washington.
Gun owners, gun control proponents, realtors, retirees, lawyers, small businesses, bird lovers and their brothers lobby politicians and gain benefits from it.
I'm pretty sure you've been on Capitol Hill a time or two, if what I've read on here is true. Care to tell us what you received for Christmas the last five years, and document it down to the exact dollar value?
James: I have no idea if you regularly shill for Big Pharma and I don't really care. But why would you not want your medicines to be developed by non-profit making companies? All that matters is that they are efficacious and safe. I can recall a time when most people in the industry, sales reps included, took a genuine pride in their products and the benefits they provided. That motivational pride has been replaced by profit and greed, and we are seeing the results.
"Big Pharma" simply can't be trusted to do what is best for its customers any more.
Melody's views are not new but they are correct. Her "little knowledge" is only dangerous to the racketeers who have hijacked the pharmaceutical industry. Your apparent ignorance of this reality is either breathtaking or disingenuous, James, and I suspect it can only be funded by the pharmaceutical industry itself.
James,
Never accepted a dime, or a gift from anyone. My husband and I did rcve condolence cards and flowers when my mother-in-law passed away in 2005 (Does That Count)other than that Im not interested in being beholden to anyone.
Outside the box, you state: . . .the legal responsibility that management has to make a profit. Yes, it is a legal responsibility in public companies that they make profit unless the share holders have given them permission not to.
Many health-related blogs reveal a multitude of culprits; perhaps you've hit the nail on the head. I don't see 'capitalism' as the problem, but rather unbridled capitalism . . . which has given rise to pharma's need/demand for blockbuster drugs and record-breaking profits. Perhaps corporations (and their shareholders) should be challenged to shift priorities away from exorbitant executive salaries/perks and shareholder demand for ever-escalating ROI. If employees (the backbone of any corporation) and consumers (without which a corporation would cease to function) were given the same value as management and shareholders, wouldn't EVERYONE benefit?
I have appreciated MP's reporting for several years. Glad to see that she has put it together in this book.
Re: other generally accessible works, I am personally most positive about Phil Hilts' _Protecting America's Health_ (history of the FDA from a center-left perspective, also former NYT reporter); Howard Brody's _Hooked_ (mostly on rel between medicine and industry by a guy who is both a distinguished physican and ethicist); and - not easy to find anymore - John Braithwaite's book on Corruption and the Pharm Industry (not remembering exact title, but it is a far more subtle work than that may suggest). To me, these are not simply "exposes" - of which there is now no shortage - but include serious policy reflections.
_Dark Remedy_ - a study of thalidomide - is still very much worth reading. So is Thomas Moore's _Deadly Medicine_ about the anti-arrhytmics.
She is right on, but doesn't even know the worst of marketing aggression. Been there done that, it is much worse than she thinks.
Big Pharma should be held to a higher standard. Medications impact aptients health and lives! I'm not sure what planet James is from, but his views are out of this world. Perhaps another marketer or salesman from the Imperial Deathstar?
Has anyone looked at the intersection of the pressure of insurance companies and aggressive marketing? Is it any coincidence that at the same time the aggressive marketing ramped up, insurance companies began to treat physicians as mindless sheep and require stricter formularies? My point is that one group, in isolation, doesn't paint the whole picture. The larger question of increasing marketing, costs, etc. has to be put in the same context as the rest of the players within the healthcare space. The need to paint one villain is very tempting, but there are many forces at work here.
Giles, I have no idea if you regularly jump to conclusions about a person's point of view and frankly I don't care. I don't want a non-profit developing drugs because they rarely get actual results. What is the last disease a non-profit cured? What was the last social ill a non-profit resolved?
I want for-profit companies creating my drugs because the profit motive is the best way to ensure responsiveness to me, the customer.
You also wrote: “Big Pharma” simply can’t be trusted to do what is best for its customers any more.
Of course they can't. No company can, or ever should be. Companies aren't in business to do what is best for its customers. Companies are in business to make profit. Further, non-profits can't be "trusted" to do what is right for their stakeholders, and gov't can't be "trusted" to do what it right for constituents.
If you trust anyone to do what is right for you, rather than doing research for yourself and *choosing* what is best for you, you deserve what you get.
Your apparent ignorance of this reality is either breathtaking or disingenuous, Giles, and I find it quite sad.
And CV MD, you argue that big pharma should be held to a higher standard. Why? Because medications impact health? So? Maybe people should be held to a higher standard, to make decisions about what they put into their own body.
I wouldn't trust you to make decisions about what goes into my body. I don't trust pharma companies, either. And I don't trust doctors to tell me the truth about that advantage of one statin over another. It's called research.
Now, if a company demonstrably lies about their product, sue their executives into a life of fast food (I think Justice in Michigan and I agree on that one--I even support easily piercing the corporate veil). But giving doctors CME in Costa Rica has absolutely nothing to do with patient safety.
Patients unwilling to do some work themselves before they put a drug in their body, however, does have a lot to do w/ patient safety. That's as true on Earth as it is on the Death Star.
There is only one group of villains for me; Lilly execs who lied, thus allowing many people to die (all down in black and white on the blog furious seasons). There was justice in the case of the Enron execs and some are in prison. Why has there been no justice in the pharmaceutical world when the crime resulted in innocent people being killed?
Ah, "James". I could use a talent like yours to help me write my own blog, you really are so funny. So you want people to knock up their own medicines in their bathtubs? Or maybe chew strange-looking herbs from their backyards if they get sick? People used to be able to trust drug companies to provide them with safe medicines - not the sort of work Joe Public can "research" on his own, really. So your message to the families affected by, say, Vioxx, is "serves you right for making a bad consumer choice"? How interesting. Ah, such is the thinking in George Bush's America. So glad I don't live there...
Pharma Giles, I can't tell you the number of lectures I have gotten about "doing research" before my son took Zyprexa. First of all, he was pushed into it when he took Medicaid, no doubt by a drug rep who sold the overworked psychiatrist the party line. Secondly, we had never been "tricked" and lied to before; my son having been on lithium for years - there was no profit in lying about a generic. Plus, my son had a real, ethical doctor who exhaustively explained everything. Third, in 2001, there was next to nothing the literature anyway. It was all tucked away in Lilly's vault, and in the FDA's Medwatch statistics, which are not revealed. Ut has been a cruel criticism to be told I should have "done research". Though, dear God, I wish I'd known about hyperglycemia and what it looks like - if this had been the case,my son might have made it.
Giles, I don't know whether to respond to your comments as though they were actually sincere, or to roll my eyes and move on. For whatever reason, I will opt for the former:
1. "Joe Public" can't read up on what drugs do? Funny, I have no problem finding all kinds of info on what drugs actually do, from legit sources, and I have no special access.
2. Clearly I'm not advocating people manufacture their own drugs. That's not even a good straw man.
3. I wrote in the same post that if companies lie about their drugs, they should be sued to the hilt. That answers your Vioxx claim. By the way, your beloved gov't regulators concluded a few years ago that Vioxx has an acceptable risk/benefit profile for certain patients. Further proof you can't trust the gov't to protect you, perhaps.
4. You wrote "People used to be able to trust drug companies to provide them with safe medicines". Really? When was this? Was it Tylenol in the 1980s? Was it the Dalkon Shield in the 1970s? How about Thalidomide in the 1950s? Elixir Sulfanilamide in the 1930s?
Please enlighten me as to when this golden age of trustworthy companies was.
I think James is either brainwashed or has his head in the sand. Companies that are in the business of healthcare need to care about the health of patients. When they stop caring, they deserve to be called out on the carpet for their misdeeds. Should everyone forgive and forget about Purdue, merck, lilly, Schering-plough, Pfizer and all the other companies that have been called into court and fined for their defrauding of the governement and the public. Absolutely not! Where in the world are you coming from? The business of pharma should be way diffeent than soda pop or cereal!
Didn't Bush sign a law last year, which makes all drug companies publish phase 11-1V study results. Ted Kennedy et al. introduced the bill. I know that DTC was a compromise. Isn't this a positive move? When it comes down to it, the science matters, clinical trial results. I know that clinical trial design is manipulated by design and shady statisticians guided by some shady MDs (this applies very much to the medical device industry the most corrupt and still under the radar). But scientists are smart enough to pick out the statistical problems with trials if they are independent, but that is the question of the moment. Who is independent? Am I wrong?
Funny how trendy it is to attack pharma. Big evil Satan. Of course, when pharma comes up with that cure for Alzheimer's, I bet Melody and Giles will be in line.
Of course pharmaceutical companies are in the business of making money. Duh. And they will make what they are incentivized to make. At this time, Wall Street incentivizes me-too, make-profit-and-make-it-quick drugs like the new SNRI Wyeth is coming out with. But guess what? Any consumer out there can say, "No thanks, Doc, I'll take that generic Effexor XR that's available." And any doctor worth his/her salt can look at the efficacy/safety/tolerability profile of a new med and an old med and make a prescribing decision based on that. What magicians we pharma reps must be to persuade a doctor to write only our products?
Marketing is an important tool in any industry, including pharma. Most doctors will not willingly do the research necessary to learn about new drugs on the market, especially if the drug is a new class of drugs. When Prozac came out, it took a huge marketing effort by Lilly to convince doctors to try it instead of relying on the old stand-bys, the tri-cyclics and the MAOIs. Prozac CLEARLY had safety benefits (tricyclics are fatal in overdose and hello, depressed people OD on their meds!) and tolerability benefits (weight gain, drowsiness, orthostatic hypotension, to name a few). Despite these clear benefits, physicians had to be SOLD on the benefits of the SSRIs. Now, do we need a dozen SSRIs? Probably not. But again, this is a matter of getting Wall Street to incentivize different behavior on the part of pharma.
What about these vaunted non-profit organizations doing all our pharma research for us? Where would that money come from? There are not enough tax dollars in the world to fund that effort. There is too much risk, too much liability and too much failure in pharma development to take it out of the private sector. And those occasional blockbuster drugs like Paxil or Cialis fund less successful, less profitable medications for less glamorous diseases.
And drug companies haven't necessarily "defrauded" anyone, despite these large lawsuits won by the government against companies like Pfizer or Lilly. Doctors use drugs off-label all the time. Getting indications is expensive--if a drug works for neuropathic pain of one kind, chances are very good it will work for neuropathic pain of another kind. Pfizer paid a huge fine for Neurontin--but guess what? The drug worked for all kinds of pain, not just the indication it had. That's not fraud--it's the government raping a company because it can in an effort to fill its coffers.
As for bad outcomes--every thing in life has risks and benefits. Corporations should be punished for knowingly selling products without revealing the dangers. If Merck knew about the cardiac risks with Vioxx and did not reveal those to the public, then sue them for everything they've got. But don't forget that side effects from drugs often take years and years to show up--if we did enough clinical trials to show up those side effects, a drug would never get to market. You pays your money and you takes your chances with just about everything in life. No one is forcing pills down your throat. Everyone of those Vioxx patients had the choice of living with their pain.
And by the way, America, take a little responsibility. You want to super-size everything, sit on the couch and watch American Idol, smoke two packs a day...then you want a pill to make it all better. Then you complain when the pill is expensive and has side effects. You are obese and putting incredible strain on your joints, causing all sorts of chronic pain, then you want a pill to make the pain go away. But make it free and no side effects!
And Zyprexa lady? I am really, really sorry your son died. But I can't tell you how many psychiatrists I had tell me, for years, that their patients' weight, blood sugar, blood pressure and cholesterol were not their concern. Everyone on the psychiatric planet knew that Zyprexa caused weight gain. Perhaps your son's physician made the best decision he could to treat your son's symptoms. Perhaps he was really comfortable with Zyprexa and unwilling to try anything new, despite other pharma reps best efforts. Perhaps your son liked the way he felt on Zyprexa and asked your doctor not to change the meds. I have seen all of these things. Despite what happened to your son, Zyprexa is a good medicine and has helped millions of people. It's always a matter of risk vs. benefit, and sometimes bad things happen.
Go ahead and flame me, all of you who love to pretend that big pharma is the most evil thing on earth. When you get cancer and want chemo, I want to see you shun pharma. When you or your friend gets MS, I want to see you shun pharma. When your mom has a stroke and needs a clot-buster, I want to see you shun pharma. And that Alzheimer's lurking in the future for 1 of 8 Americans? Just so you know, pharma is throwing billions at that problem. But I expect you aren't interested, because God forbid, pharma might make a profit on it.
And by the way, I expect that all of you who post scathing remarks on the fact that pharma turns a profit are working for free. Melody won't make any money on this book; Giles, whatever you do, you receive minimal compensation? CV doc, don't even get me started--what are you pulling down, $500,000 a year? The guy who built my house is doing pretty well--how dare he? Housing is a RIGHT--no one should make a profit on it. I and my kids would die in a northern winter without a house--contractors should be held to a higher standard. And food!! All these people making money on food (except the illegal immigrants, who make bupkis)--and sometimes the food is bad!! and kills people!! I have to have a car--can't work without one. UAW members? How dare you demand pensions and health benefits and no co-pay for your meds? You are driving the price of my car up, and I think it should be less expensive, because after all, a car is a necessity.
Ah, America and the entitlement mentality. Go after pharma and kill it. Don't laugh, docs, you're next. The only industries that are safe are the lawyers and any industry that relies on union labor.
The great thing about this blog is that people from across the spectrum of opinions have a chance for thoughtful and respectful reflection. Usually, people don't flame. They try to listen to each other, even when they disagree. From time to time, they even learn from each other. Very few people use it for same old, same old tirades.
Very true Justice. Except for the two comments immediately before yours :-|
Horus-Cat: Egyptology. That versus science? No contest.
Satan: Religion-Belief. That versus Science? No contest. Awaiting pharma coming up with a CURE for alzheimers. They've tried passing cures off, they aren't scientific, they don't work. Won't happen.
Pharma Turns A Profit and You Don't: Myth. Get Paid? Most of us pay for our websites and so are LOSING money, not MAKING a profit.
"Prozac CLEARLY had safety benefits (tricyclics are fatal in overdose and hello, depressed people OD on their meds!) and tolerability benefits (weight gain, drowsiness, orthostatic hypotension, to name a few). Despite these clear benefits, physicians had to be SOLD on the benefits of the SSRIs."
Wow. So they were. The clear benefits of Prozac included homicidal and suicidal ideation. So they shot and hanged themselves instead. But great you managed to sell prozac on those CLEAR benefits.
It has to be a great benefit that mentally healthy trial volunteers killed themselves on Prozac and its cousins. Great selling to doctors, congratulations from the dead.
"The guy who built my house is doing pretty well–how dare he? Housing is a RIGHT–no one should make a profit on it. I and my kids would die in a northern winter without a house–contractors should be held to a higher standard."
Your HOUSE Horus, has not killed you and, short of an earthquake, is not likely to. Therefore your house contractors have done nothing other than give you shelter and so are entitled to make a profit.
Drugs that kill people, Horus, do the opposite.
"And Zyprexa lady? I am really, really sorry your son died. But I can’t tell you how many psychiatrists I had tell me, for years, that their patients’ weight, blood sugar, blood pressure and cholesterol were not their concern. Everyone on the psychiatric planet knew that Zyprexa caused weight gain. Perhaps your son’s physician made the best decision he could to treat your son’s symptoms. Perhaps he was really comfortable with Zyprexa and unwilling to try anything new, despite other pharma reps best efforts. Perhaps your son liked the way he felt on Zyprexa and asked your doctor not to change the meds. I have seen all of these things. Despite what happened to your son, Zyprexa is a good medicine and has helped millions of people. It’s always a matter of risk vs. benefit, and sometimes bad things happen."
HORUS, fantastical comment. Sometimes bad things happen? Zyprexa has helped millions of people? Please give evidence of your statement.
"Perhaps your son liked the way he felt on Zyprexa and asked your doctor not to change the meds."???
WOW. ARE YOU A PSYCHIARIST who never listens to his patients telling him how bad they feel on the drugs you give him? If you are, change jobs, you're no good at psychiatry.
In fact, Horus, you're no good at whatever you're doing on the drug front. Give it up. Find something that benefits human life, something that benefits your own living. Leave what you're doing. At the moment you die, you will have no choice but to look back at what you did, what you caused, who you killed.
CHANGE YOUR VOCATION before its too late for YOU.
Evem Egyptologists can repent. REPENT!
REPENT!
And if that didn't answer your soul's problem then what the END of it here:
REPENT !
You, HORUS, will not triumph over the human spirit. Don't even try because those who do will have a bad end.
Justice in Michigan, John Braithwaite's excellent books include:
Braithwaite J. Restorative Justice and Responsive Regulation Oxford: Oxford University Press; 2002 http://www.oup.co.uk/isbn/0-19-515839-3
Braithwaite J, Drahos P. Global business regulation. Cambridge: Cambridge University Press; 2000 http://www.cambridge.org/uk/catalogue/catalogue.asp?isbn=0521784999
Braithwaite J. Corporate crime in the pharmaceutical industry. London: Routledge & Kegan Paul; 1984 http://www.amazon.com/exec/obidos/tg/detail/-/0710200498/qid=1124498017/sr=1-1/ref=sr_1_1/002-4340062-2313626?v=glance&s=books
These and many others relating to pharmaceutical marketing are listed in Healthy Skepticism's library: http://healthyskepticism.org/library/search.php
HorusCat, you state: "Go ahead and flame me, all of you who love to pretend that big pharma is the most evil thing on earth."
May I point out that this site is PHARMALOT . . . not CafePharma. Obviously, you got your 'training' and 'expectations'(of flaming) on the site run for 'professional' drug reps.
Dear HorusCat,
Wow! You've got some serious issues! Behavior modification may be of assistance. Temper conrol is certainly needed. This blog started with Ed writing up an interview with the author of a boob on the industry. Calm down, look around, and take in th world around you.
Phew! Have all the "professional" (and I use the term very loosely) Sales Reps finished posting here yet?
Do us a favor and copy this over to cafe pharma and finish your diatribe over there...Geesh, maybe we should give a bonus to Doctors just for listening to you, because I sure find it annoying.
Former Pharma,
Im sure the diatribe can be cured with a good night's sleep.
Hmm. I don't see how being upset about "numerous examples in which drugmakers used a plethora of controversial tactics - manipulating clinical trial data; seducing doctors with freebies; promotional stunts that obscured side effects - to drive sales" equates with thinking drugs are evil and that the companies that make drugs are evil. Are we supposed to just roll over when megacorporations lie to us about how safe their products are? Business ethics hasn't always been an oxymoron.
How did this - "manipulating clinical trial data; seducing doctors with freebies; promotional stunts that obscured side effects - to drive sales" - become good business practice, HorusCat? Your conclusions don't make any sense. Of course we want the latest and greatest pharmaceuticals. We don't want shit painted yellow and sold to us as gold. Now why is that hard to understand?
Cute, Harpy.
Against my own better judgement, just this add-on re: Neurontin as an example. Absolutely true that it is effective for all kinds of off-label applications (and some that it was pushed for, but not). WL knew that and deliberately decided not to seek approval so they could do so for Lyrica ("son of Neurontin," below). Have cake, eat it too.
Here is FDA's summary of the case. The FDA is not known for seeing the industry as Great Satan, for knee-jerk responses, nor for tirades.
The point is, to have a real discussion about what is and isn't fraud, you can't pick out a small bit and ignore all the rest - the context in which the small bit occurred.
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Drug Maker to Pay $430 Million in Fines, Civil Damages
Pharmaceutical manufacturer Warner-Lambert has agreed to plead guilty and paymore than $430 million to resolve criminal charges and civil liabilities in connection with its Parke-Davis division's illegal and fraudulent promotion of unapproved uses for the drug Neurontin (gabapentin). The drug was approved by the Food and Drug Administration in December 1993 solely for use with other drugs to control seizures in people with epilepsy.
Under the provisions of the Federal Food, Drug, and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the FDA. Once approved, the drug may not be marketed or promoted for so-called "off-label" uses--any use not specified in an application and approved by the FDA.
Warner-Lambert's strategic marketing plans, as well as other evidence, show that Neurontin was aggressively marketed to treat a wide array of ailments for which the drug was not approved, according to a recent press statement from the U.S. Department of Justice. The company promoted Neurontin for the treatment of:
bipolar mental disorder various pain disorders amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig's disease attention-deficit disorder migraine drug and alcohol withdrawal seizures restless leg syndrome. The company also promoted the drug as a first-line monotherapy treatment for epilepsy--using Neurontin alone, rather than in addition to another drug.
Warner-Lambert promoted Neurontin even when scientific studies had shown it was not effective. For example, the company promoted Neurontin as effective for use as the sole drug for epileptic seizures, even after solo use had been specifically rejected by the FDA. Similarly, the pharmaceutical company falsely promoted Neurontin as effective for treating bipolar disorder, even when a scientific study demonstrated that a placebo worked as well or better than the drug.
"This illegal and fraudulent promotion scheme corrupted the information process relied upon by doctors in their medical decision-making, thereby putting patients at risk," says U.S. Attorney Michael Sullivan. "This scheme deprived federally-funded Medicaid programs across the country of the informed, impartial judgment of medical professionals--judgment on which the program relies to allocate scarce financial resources to provide necessary and appropriate care to the poor. The pharmaceutical industry will not be allowed to profit from such conduct nor subject the poor, the elderly, and other persons insured by state and federal health care programs to experimental drug uses which have not been determined to be safe and effective."
As a consequence of the unlawful promotion scheme, patients who received the drug for unapproved and unproven uses had no assurance that their doctors were exercising their independent and fully informed medical judgment or whether the doctor was instead influenced by misleading statements or inducements from Warner-Lambert. Potential problems that can arise from off-label use without the benefit of careful FDA oversight include the occurrence of unforeseen problems because the drug was not studied in the type of patient it is being used for off-label, and the appropriate dosage and course of treatment have not been established.
Warner-Lambert used a number of tactics to achieve its marketing goals, including encouraging sales representatives to provide one-on-one sales pitches to physicians about off-label uses of Neurontin without prior inquiry by doctors. The company's agents also made false or misleading statements to health care professionals regarding Neurontin's efficacy and whether it had been approved by the FDA for the off-label uses. Warner-Lambert also used "medical liaisons," who represented themselves (often falsely) as scientific experts in a particular disease, to promote off-label uses for Neurontin.
Warner-Lambert paid doctors to attend so-called "consultants' meetings" in which physicians received a fee for attending expensive dinners or conferences during which presentations about off-label uses of Neurontin were made. These events included lavish weekends and trips to Florida, the 1996 Atlanta Olympics, and Hawaii. There was little or no significant consulting provided by the physicians.
The pharmaceutical company implemented numerous teleconferences in which physicians were recruited by sales representatives to call into a prearranged number where they would listen to a doctor or Warner-Lambert employee speak about off-label use of Neurontin. The company also sponsored purportedly "independent medical education" events on off-label Neurontin uses with extensive input from Warner-Lambert regarding topics, speakers, content, and participants.
Warner-Lambert misled the medical community beforehand about the content, as well as the lack of independence from the company's influence, of many of these educational events. In at least one instance, when unfavorable remarks were proposed by a speaker, Warner-Lambert offset the negative impact by "planting" people in the audience to ask questions highlighting the benefits of the drug.
Warner-Lambert paid physicians to allow a sales representative to accompany the physician while he or she saw patients, with the representative offering advice regarding the patient's treatment that was biased toward the use of Neurontin.
These tactics were part of a widespread, coordinated national effort to implement an off-label marketing plan. At the same time, Warner-Lambert decided not to seek FDA approval for any of the new uses because it was concerned that approval for any of the non-epilepsy uses would allow generic competitors of Neurontin to compete with a "son of Neurontin" drug that Warner-Lambert hoped to have approved by the FDA for both epilepsy and non-epilepsy uses.
Neurontin was put on the market in February of 1994. From mid-1995 to at least 2001, the growth of off-label sales was tremendous. While not all of these sales were the consequence of Warner-Lambert's illegal marketing, the marketing scheme was very successful in increasing Neurontin prescriptions for unapproved uses.
The investigation began in the District of Massachusetts when a former medical liaison for Warner-Lambert, David Franklin, M.D., filed suit on behalf of the U.S. government. Private individuals are allowed to file whistleblower suits under the federal False Claims Act to bring the United States information about wrongdoing. If the United States is successful in resolving or litigating the whistleblower's claims, the whistleblower may share part of the recovery. As a part of the resolution, Franklin will receive about $24.6 million of the civil recovery.
The Federal Bureau of Investigation, the Department of Veterans Affairs' Office of Criminal Investigations, the FDA's Office of Criminal Investigations, and the Office of Inspector General for the Department of Health and Human Services conducted the investigation.
Terms of the agreement include:
Warner-Lambert has agreed to plead guilty to two counts of violating the Federal Food, Drug, and Cosmetic Act with regard to its misbranding of Neurontin by failing to provide adequate directions for use and by introduction into interstate commerce of an unapproved new drug. Warner-Lambert has, as punishment for these offenses, agreed to pay a $240 million criminal fine, the second-largest criminal fine ever imposed in a health care fraud prosecution. Warner-Lambert has agreed to settle its federal civil False Claims Act liabilities and to pay the United States $83.6 million, plus interest, in civil damages for losses suffered by the federal portion of the Medicaid program as a result of Warner-Lambert's fraudulent drug promotion and marketing misconduct. Warner-Lambert has agreed to settle its civil liabilities to the 50 states and the District of Columbia in an amount of $38 million, plus interest, for harm caused to consumers and to fund a remediation program to address the effects of Warner-Lambert's improper marketing scheme. Pfizer Inc., Warner-Lambert's parent company, has agreed to comply with the terms of a corporate compliance program, which will ensure that the changes Pfizer Inc. made after acquiring Warner-Lambert in June 2000 are effective in training and supervising its marketing and sales staff.
RE the comments of "Horus" to me, "Zyprexa Lady". As someone else stated, I hope that you can save your soul (if you have one left) by leaving working where you do , Walk a mile in my moccasins and imagine that your only son, who did fine on lithium for nine years, was suddenly and with no notice killed by Zyprexa. Imagine his last word in the ER, a scream..."Mom". Then think twice the next time you utter the inhumane words to anyone that you did to me. I have friends who lost their sons to Zyprexa WITH NO WARNING. One is filled with anger and despair as well and is WRITING A BOOK. The other couple are also angry and full of despair. In each case, their sons were their only children. ONLY CHILDREN.
I feel very sorry for you and for your family. Imagine equating this "industry" with others. Houses, shoes, sodas, don't KILL WITHOUT WARNING; the company does not hide the killing effects of its product. No, it's only Pharma that does this.
HC - What is your view of FDA's summary of the Neurontin case?
HorusCat,
Hmmm, gonna go out on a limb here and assume that your Mother is not a child or adolescent for which psychotropic drugs carry Black Box Warnings. Your story of your mother's success on an antidepressant, is simply anecdotel.
Shit yellow,.... How about Blood Red
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