It's true that the drug industry was hard hit last year with some pretty hefty fines for the illegal off-label promotion of drugs -- $1.4 billion against Eli Lilly for its off-label promotion of Zyprexa and $2.3 billion against Pfizer for doing the same with several drugs. But such fines, many say, are still considered the cost of doing business in an industry that raked in close to $300 billion in U.S. drug sales in 2008 (and more in 2009), according to IMS Health Reports.
Now, Alaska attorney Jim Gottstein has proposed a different and potentially more effective approach toward curbing the systemic over-drugging of economically disadvantaged youngsters in this country, a sad reality which I've written about here and here. According to one recent study, children covered by Medicaid are given anti-psychotics such as Zyprexa and Seroquel (which have serious side effects) four times as often as children whose parents have private insurance. These drugs are often prescribed as chemical straitjackets to control children whose parents or foster families are unable to give them the attention and parenting they need. That was certainly the case for four-year-old Rebecca Riley, who died from an overdose of psychoactive drugs prescribed by a psychiatrist at Tufts Medical Center, Kayoko Kifuji.
Gottstein has launched an initiative to sue doctors like Kifuji who blithely prescribe potent drugs that are not approved for use in children. These lawsuits, filed under a federal Qui Tam complaint, would target not only the individual doctors but the hospitals and clinics that employ them and the pharmacies that fill their prescriptions and submit them to Medicaid for reimbursement. It is Gottstein's contention that these prescriptions constitute Medicaid fraud since they are written for uses that are not medically accepted (i.e. off-label). There is legal precedent for this kind of argument. Indeed, the Department of Justice's news release announcing its $2.3 billion settlement with Pfizer says that the drug giant caused false claims to be submitted to government health care programs for uses that were not medically accepted indications. So if the feds can succeed with this kind of argument, why not individual claimants?
Gottstein is planning to discuss his medicaid fraud initiative in a lecture webinar on Feb. 24, sponsored by the International Center for the Study of Psychiatry and Psychology. So if you know of a disadvantaged child who was slapped on drugs he or she didn't need, you might want to listen in.
Monday, February 8, 2010
Friday, January 29, 2010
Clinical trial research driven by marketing, not evidence
Those of you in the mood for a serious read might want to check out an article in the Journal of Bioethical Inquiry about the way in which many drug companies use their marketing muscle to mislead physicians and consumers about the safety and effectiveness of their products.
This is not news, of course. In recent years, the mainstream media and blogs like this one have spotlighted specific examples where drug companies have achieved blockbuster profits through such smarmy tactics as ghostwriting, the suppression of negative findings, the publication of journal articles that report only positive findings, and paying prominent physicians to convince their peers of the drugs' benefits. Indeed, the illicit marketing campaigns that antidepressant makers like Pfizer, Eli Lilly and GlaxoSmithKline developed to make drugs like Prozac, Paxil and Zoloft look safer and more effective than they really were are the subject of several books, including Side Effects.
What's worthwhile about the article in Bioethical Inquiry is that it makes very clear how widespread this practice of "marketing-based medicine" is and how unreliable our so-called "gold standard" of medical research -- randomized clinical trials -- really is. In too many cases, drug companies, which fund these trials and cherrypick the researchers whose names appear on them, not only ghostwrite the results to hide negative data and overstate the positive. But they also make sure that any truly negative trials never see the light of day. And then once the misleading results are published in supposedly reputable journals, the drug companies use prominent physicians (on their payroll) to market the hell out of them.
In their roundup, the authors, Glen Spielmans and Peter Parry, show how all this worked -- not only with the antidepressant campaigns but also in the way that Eli Lilly and AstraZeneca went about promoting their antipsychotic drugs, Zyprexa and Seroquel and suppressed the drugs' negative side effects to increase market share.
Spielmans and Parry suggest an interesting, if radical, solution: that journals should cease publication of clinical trials, since the much-vaunted process of peer review doesn't seem very effective in weeding out erroneous trial results. Instead, they suggest that trial results could be published in some form of online registry, and that journal articles could focus on the validity of these trial results. Of course, this would deprive the journals of a major source of revenue: reprints of positive trial results (which the drug companies use in their marketing blitzes), as well as lucrative advertising revenue. So don't look for this kind of systematic reform any time soon.
This is not news, of course. In recent years, the mainstream media and blogs like this one have spotlighted specific examples where drug companies have achieved blockbuster profits through such smarmy tactics as ghostwriting, the suppression of negative findings, the publication of journal articles that report only positive findings, and paying prominent physicians to convince their peers of the drugs' benefits. Indeed, the illicit marketing campaigns that antidepressant makers like Pfizer, Eli Lilly and GlaxoSmithKline developed to make drugs like Prozac, Paxil and Zoloft look safer and more effective than they really were are the subject of several books, including Side Effects.
What's worthwhile about the article in Bioethical Inquiry is that it makes very clear how widespread this practice of "marketing-based medicine" is and how unreliable our so-called "gold standard" of medical research -- randomized clinical trials -- really is. In too many cases, drug companies, which fund these trials and cherrypick the researchers whose names appear on them, not only ghostwrite the results to hide negative data and overstate the positive. But they also make sure that any truly negative trials never see the light of day. And then once the misleading results are published in supposedly reputable journals, the drug companies use prominent physicians (on their payroll) to market the hell out of them.
In their roundup, the authors, Glen Spielmans and Peter Parry, show how all this worked -- not only with the antidepressant campaigns but also in the way that Eli Lilly and AstraZeneca went about promoting their antipsychotic drugs, Zyprexa and Seroquel and suppressed the drugs' negative side effects to increase market share.
Spielmans and Parry suggest an interesting, if radical, solution: that journals should cease publication of clinical trials, since the much-vaunted process of peer review doesn't seem very effective in weeding out erroneous trial results. Instead, they suggest that trial results could be published in some form of online registry, and that journal articles could focus on the validity of these trial results. Of course, this would deprive the journals of a major source of revenue: reprints of positive trial results (which the drug companies use in their marketing blitzes), as well as lucrative advertising revenue. So don't look for this kind of systematic reform any time soon.
Monday, January 25, 2010
Doctor on Glaxo payroll tells Harvard Sayonara
Remember Dr. Lawrence DuBuske, the Harvard Medical School allergist whom I outed as the highest paid doctor on GlaxoSmithKline's payroll for the second quarter of last year? Rather than give up his lucrative speaking and consulting gigs for Glaxo and myriad other drug companies, DuBuske has decided to part ways with Brigham and Women's Hospital and Harvard Medical School, according to The Boston Globe.
Can't say I blame him. DuBuske, after all, earned a whopping $99,375 from just Glaxo in only three months last year, as I reported here. He also was getting speaking bucks from Schering-Plough, Merck and Sanofi-Aventis. Indeed, as the disclosures in a March 2009 journal article show, DuBuske is basically on the speaking payroll of every pharmaceutical company that makes or markets allergy drugs in this country.
So when DuBuske was notified that his speaking gigs are now in direct violation of Partners' new conflict-of-interest policy, he chose to keep the income and dispense with the titles. He only saw patients at Brigham's on a consult basis, after all, and was a part-time instructor at Harvard Medical School.
DuBuske, however, is also director of the Immunology Research Institute of New England, a nonprofit Gardner-based organization that works with medical researchers throughout Eastern Europe on educational programs and clinical studies of new allergy drugs. It is no doubt his work with this institute and all those bargain-priced clinical researchers in Eastern Europe that makes DuBuske so valuable to allergy drug makers. You can bet he's not giving that gig up.
Can't say I blame him. DuBuske, after all, earned a whopping $99,375 from just Glaxo in only three months last year, as I reported here. He also was getting speaking bucks from Schering-Plough, Merck and Sanofi-Aventis. Indeed, as the disclosures in a March 2009 journal article show, DuBuske is basically on the speaking payroll of every pharmaceutical company that makes or markets allergy drugs in this country.
So when DuBuske was notified that his speaking gigs are now in direct violation of Partners' new conflict-of-interest policy, he chose to keep the income and dispense with the titles. He only saw patients at Brigham's on a consult basis, after all, and was a part-time instructor at Harvard Medical School.
DuBuske, however, is also director of the Immunology Research Institute of New England, a nonprofit Gardner-based organization that works with medical researchers throughout Eastern Europe on educational programs and clinical studies of new allergy drugs. It is no doubt his work with this institute and all those bargain-priced clinical researchers in Eastern Europe that makes DuBuske so valuable to allergy drug makers. You can bet he's not giving that gig up.
Tuesday, January 19, 2010
Why the FDA is more probusiness than ever
It's nice to see that Massachusetts anesthesiologist Scott Reuben has plead guilty to faking medical research and agreed to pay restitution fees for his fraud. But there is one aspect of his plea agreement with federal prosecutors (which he signed last week in the hopes of a more lenient sentence) that troubles me: why is he paying $420,000 in restitution fees to the very drug companies that benefited handsomely from his faked research and rewarded him with speaking fees? (Reuben's plea deal was first reported in The Day).
To recap, Reuben, an anesthesiologist at Baystate Medical Center in Springfield, fabricated positive data on at least 21 studies of drugs, mostly painkillers such as Vioxx, Bextra and Celebrex; background here. Reuben received research grants from the makers of these drugs, and he was also getting lucrative speaking fees from at least two of the companies: Pfizer (which makes Bextra and Celebrex) and Merck (Vioxx). And now he is required to pay Pfizer $296,000, $16,000 to Wyeth, (now owned by Pfizer), and $49,375 to Merck, all in restitution for taking their money and then faking positive findings about their drugs. Rich, huh? I'm sure these companies are laughing all the way to the bank.
On an equally disturbing note: Jim Dickinson, the editor of FDA Webviews, an industry newsletter that follows the agency, has concluded that the FDA is more pro-business than at any time in 35 years. According to Gooznews, Dickinson writes:
And what does Dickinson blame for this tectonic shift in the federal agency's culture? The same culprit I singled out in Side Effects: the Prescription Drug User Fee Act, passed in 1992. I reported that industry user fees now account for more than than half of the FDA's entire drug review budget and as a result, the agency has become increasingly beholden to the very industry it is supposed to regulate. Or, to quote Dickinson:
To recap, Reuben, an anesthesiologist at Baystate Medical Center in Springfield, fabricated positive data on at least 21 studies of drugs, mostly painkillers such as Vioxx, Bextra and Celebrex; background here. Reuben received research grants from the makers of these drugs, and he was also getting lucrative speaking fees from at least two of the companies: Pfizer (which makes Bextra and Celebrex) and Merck (Vioxx). And now he is required to pay Pfizer $296,000, $16,000 to Wyeth, (now owned by Pfizer), and $49,375 to Merck, all in restitution for taking their money and then faking positive findings about their drugs. Rich, huh? I'm sure these companies are laughing all the way to the bank.
On an equally disturbing note: Jim Dickinson, the editor of FDA Webviews, an industry newsletter that follows the agency, has concluded that the FDA is more pro-business than at any time in 35 years. According to Gooznews, Dickinson writes:
It has taken almost a generation, but by now, the pro-industry infiltration of FDA's culture is firmly entrenched. Not only is collaboration in product reviews officially encouraged, but good relationships across the regulatory fence hold the prospect of a possible future career in a well-paid industry job.
And what does Dickinson blame for this tectonic shift in the federal agency's culture? The same culprit I singled out in Side Effects: the Prescription Drug User Fee Act, passed in 1992. I reported that industry user fees now account for more than than half of the FDA's entire drug review budget and as a result, the agency has become increasingly beholden to the very industry it is supposed to regulate. Or, to quote Dickinson:
User fees at FDA are the primary villain, because they allowed the industry to dictate the changes at the FDA in programs, procedures and practices. It will be impossible for the Obama administration to reverse the trend because as long as the user fees are in place the industry has the upper hand.
Monday, January 11, 2010
New study finds that extended price protections on drugs do not spur innovation
As Congressional committees work to meld the House and Senate versions of the health bill and Republicans launch a last-minute effort to scuttle the entire enterprise, one unsavory element of the legislation seems to have escaped much public attention. That's the provision permitting developers of biomedical drugs (known as biologics) an additional 12 years of protection from generic competition, despite the fact that a similar price protection measure in Europe did not spur innovation or benefit patients in any way.
Currently, federal law allows makers of all drugs (including biologics) to extend their patent protection for an additional five years after their patents expire. By allowing generic manufacturers to develop and sell generics after five years, this time limit saves American consumers roughly $10 billion a year, according to a recent column in The Los Angeles Times.
But last summer, an amendment was inserted into the House and Senate versions of the health care reform bill that provides the makers of biologic drugs up to 12 years of patient protection (an extra three years every time they tweak the drug formula slightly). One of the legislators who sponsored the amendment, Anna Eshoo (whose Palo Alto district is home to lots of venture capitalists), says the additional protection is necessary to encourage biotechs to pursue new innovative drugs. (Eshoo, by the way, is the top recipient of the biotech industry's campaign donations to Congress, according to LA Times columnist Michael Hiltzik.)
However, a new study in current Journal of Health Politics, Policy and Law finds that a similar 10-year measure extending price protections for drugs developed in Europe did not spur innovation in drug development there. The main effect of the European extension on drug price protections was to raise prices and drug company profits, according to one of the study's co-authors, Don Light, a visiting professor at Stanford University. Light's study also spotlights how the European Parliament, under pressure from pharmaceutical lobbyists, rushed the measure through before less affluent countries from Easter Europe could join the European Union (in 2004) and oppose the price protections.
As Light notes, "most affected are developing countries, where [price protections] makes drugs for cancer, AIDS and other serious conditions prohibitively expensive."
What's that French saying? Plus ca change, moins ca change. The more things change, the more they stay unchanged. How apt!
Currently, federal law allows makers of all drugs (including biologics) to extend their patent protection for an additional five years after their patents expire. By allowing generic manufacturers to develop and sell generics after five years, this time limit saves American consumers roughly $10 billion a year, according to a recent column in The Los Angeles Times.
But last summer, an amendment was inserted into the House and Senate versions of the health care reform bill that provides the makers of biologic drugs up to 12 years of patient protection (an extra three years every time they tweak the drug formula slightly). One of the legislators who sponsored the amendment, Anna Eshoo (whose Palo Alto district is home to lots of venture capitalists), says the additional protection is necessary to encourage biotechs to pursue new innovative drugs. (Eshoo, by the way, is the top recipient of the biotech industry's campaign donations to Congress, according to LA Times columnist Michael Hiltzik.)
However, a new study in current Journal of Health Politics, Policy and Law finds that a similar 10-year measure extending price protections for drugs developed in Europe did not spur innovation in drug development there. The main effect of the European extension on drug price protections was to raise prices and drug company profits, according to one of the study's co-authors, Don Light, a visiting professor at Stanford University. Light's study also spotlights how the European Parliament, under pressure from pharmaceutical lobbyists, rushed the measure through before less affluent countries from Easter Europe could join the European Union (in 2004) and oppose the price protections.
As Light notes, "most affected are developing countries, where [price protections] makes drugs for cancer, AIDS and other serious conditions prohibitively expensive."
What's that French saying? Plus ca change, moins ca change. The more things change, the more they stay unchanged. How apt!
Monday, December 28, 2009
America's dangerous addiction to prescription drugs
As we start the countdown to a new decade, I have a question for you: why doesn't the US media run comprehensive stories like this piece in The Guardian about our youth's dangerous dependence on prescription drugs? Sure, there were a few short news stories noting that a plethora of legal drugs had been found in the bedroom of Brittany Murphy, the 32-year-old actress found dead in her home last week. But the mainstream media here seems averse to putting the pieces together, as The Guardian did, not only by pointing out that "prescription drugs are becoming America's new addiction," but examining why that is so.
Sure, a few bloggers (myself included) have tackled the subject. But as one of only two nations in the developed world that allow the pharmaceutical industry to advertise directly to consumers, perhaps it's time to more widely re-examine our cavalier approach to popping pills. Brittany Murphy's untimely death is one more poignant example of the truism: just because a doctor prescribes something does not mean it is safe, particularly when taken in combination with other powerful drugs. As one professor of clinical pharmacology noted in The Guardian piece: "Many of these people simply do not realize that all drugs – no matter how beneficial – are poisonous at some level."
On another note, I'm taking a short break from blogging. Will be back Jan. 11.
Sure, a few bloggers (myself included) have tackled the subject. But as one of only two nations in the developed world that allow the pharmaceutical industry to advertise directly to consumers, perhaps it's time to more widely re-examine our cavalier approach to popping pills. Brittany Murphy's untimely death is one more poignant example of the truism: just because a doctor prescribes something does not mean it is safe, particularly when taken in combination with other powerful drugs. As one professor of clinical pharmacology noted in The Guardian piece: "Many of these people simply do not realize that all drugs – no matter how beneficial – are poisonous at some level."
On another note, I'm taking a short break from blogging. Will be back Jan. 11.
Monday, December 21, 2009
Christmas comes early for 3,700 US doctors on GlaxoSmithKline's payroll
GlaxoSmithKline became the third pharmaceutical giant to start disclosing all the speaking and consulting payments it makes to US doctors, and its list is an eye-popping illustration of the rampant corruption that runs through our current system of medical research. While the majority of the doctors on Glaxo's payroll, which covers a mere three months in the second quarter of 2009, received between $1,000 and $6,000 for speaking gigs, 134 doctors netted payments of $15,000 or more, and a goodly number received very handsome payouts indeed. (In all, GSK paid out a princely sum of $14.6 million to 3,700 doctors in just three months; one can only wonder how much they dispensed for the entire year).
The highest-paid doctor on this list is Dr. Lawrence DuBuske, a clinical instructor in medicine at Harvard Medical School and director of the Immunology Research Institute of New England. DuBuske specializes in allergies and works with medical researchers throughout Eastern Europe on clinical studies of new allergy drugs. He received a whopping $99,375 from GSK in the second quarter of 2009.
For what, you might ask? That's a question better put to DuBuske, but I can tell you that a quick scrutiny of journal articles published this past year reveals that he was the lead author of a review article published in March 2009 in a respected medical journal (Current Allergy and Asthma Reports), which extolled the effectiveness of several drugs for the treatment of allergic rhinitis (the running nose and other bothersome symptoms that occur when you breathe in something you're allergic to).
Surprise, surprise, one of the drugs given an enthusiastic thumb's up in this review is Xyzal, an antihistamine made by GlaxoSmithKline. The other two are drugs made by Schering-Plough (now owned by Merck) and Sanofi-Aventis. And sure enough, DuBuske is not only on Glaxo's speaker bureau; he is also getting speaking bucks from Schering-Plough, Merck and Sanofi-Aventis. Indeed, as the disclosures in his March review indicate, DuBuske is basically on the speaking payroll of every pharmaceutical company that makes or markets allergy drugs in this country.
Gee, I wonder what Harvard Medical School or Brigham & Women's Hospital, where DuBuske is coordinator of the allergy fellowship program and a consultant, have to say about the good doctor's conflicts of interest.
Here's another example of the way Big Pharma has corrupted the way doctors get their information about new drugs: Another well-paid physician on GSK's stocking list this year was Dr. Timothy Beard, a general surgeon and director of research for Bend Memorial Clinic in Bend, Oregon. Beard received $61,380 from GSK in the second quarter of 2009 (and he's not even one of the five highest paid). As a quick Google search reveals, Dr. Beard has done clinical research on a drug called ENTEREG, made by GlaxoSmithKline, and in August 2009, he gave a presentation to the annual meeting of the Northwest Society of Colon and Rectal surgeons about how well ENTEREG works in aiding the recovery of patients who have had bowel resection surgery. Not a bad day's work for $61,380.
Now, as an unpaid blogger, I only had time to connect a few dots, but I have a feeling there is much more to be gleaned from the treasure trove of doctor payments that Glaxo and other drug companies are now disclosing (in anticipation that Congress, as part of health reform, will pass the Physician Payment Sunshine Act and require such disclosures in the future). So I hope that some of the journalists who get paid to do this will take a closer look at more of the happy beneficiaries of the pharmaceutical industry's largesse.
In the meantime, take a minute and check to see if your doctor is on Glaxo's Christmas list. Ho ho ho.
Hat tip to Pharmalot for alerting me to the GSK list.
The highest-paid doctor on this list is Dr. Lawrence DuBuske, a clinical instructor in medicine at Harvard Medical School and director of the Immunology Research Institute of New England. DuBuske specializes in allergies and works with medical researchers throughout Eastern Europe on clinical studies of new allergy drugs. He received a whopping $99,375 from GSK in the second quarter of 2009.
For what, you might ask? That's a question better put to DuBuske, but I can tell you that a quick scrutiny of journal articles published this past year reveals that he was the lead author of a review article published in March 2009 in a respected medical journal (Current Allergy and Asthma Reports), which extolled the effectiveness of several drugs for the treatment of allergic rhinitis (the running nose and other bothersome symptoms that occur when you breathe in something you're allergic to).
Surprise, surprise, one of the drugs given an enthusiastic thumb's up in this review is Xyzal, an antihistamine made by GlaxoSmithKline. The other two are drugs made by Schering-Plough (now owned by Merck) and Sanofi-Aventis. And sure enough, DuBuske is not only on Glaxo's speaker bureau; he is also getting speaking bucks from Schering-Plough, Merck and Sanofi-Aventis. Indeed, as the disclosures in his March review indicate, DuBuske is basically on the speaking payroll of every pharmaceutical company that makes or markets allergy drugs in this country.
Gee, I wonder what Harvard Medical School or Brigham & Women's Hospital, where DuBuske is coordinator of the allergy fellowship program and a consultant, have to say about the good doctor's conflicts of interest.
Here's another example of the way Big Pharma has corrupted the way doctors get their information about new drugs: Another well-paid physician on GSK's stocking list this year was Dr. Timothy Beard, a general surgeon and director of research for Bend Memorial Clinic in Bend, Oregon. Beard received $61,380 from GSK in the second quarter of 2009 (and he's not even one of the five highest paid). As a quick Google search reveals, Dr. Beard has done clinical research on a drug called ENTEREG, made by GlaxoSmithKline, and in August 2009, he gave a presentation to the annual meeting of the Northwest Society of Colon and Rectal surgeons about how well ENTEREG works in aiding the recovery of patients who have had bowel resection surgery. Not a bad day's work for $61,380.
Now, as an unpaid blogger, I only had time to connect a few dots, but I have a feeling there is much more to be gleaned from the treasure trove of doctor payments that Glaxo and other drug companies are now disclosing (in anticipation that Congress, as part of health reform, will pass the Physician Payment Sunshine Act and require such disclosures in the future). So I hope that some of the journalists who get paid to do this will take a closer look at more of the happy beneficiaries of the pharmaceutical industry's largesse.
In the meantime, take a minute and check to see if your doctor is on Glaxo's Christmas list. Ho ho ho.
Hat tip to Pharmalot for alerting me to the GSK list.
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