Latest Drugwonks' Blog
Nevada legislators are once again rolling the dice on patient safety. This time it's not some half-baked and benighted scheme for cheap "Canadian" drugs, but rather an ill-considered plan to build a chinese wall around physician-prescribing data.
Here's the full news story:
http://www.washingtonpost.com/wp-dyn/content/article/2007/04/12/AR2007041201208.html
While physician-prescribing data shouldn’t be available for marketing purposes minus physician knowledge and consent, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.
When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor†letters to the physicians who have prescribed the drug in question. This is accomplished quickly and precisely because the industry has access to accurate data. And when safety issues arise, that same data helps define the scope of the problem. Because of this data, for example, the FDA can determine how many patients were taking a specific drug and for how long each patient had been taking it.
Further, FDA-mandated risk management plans — developed for physicians who prescribe higher-risk therapies — are physician-targeted through the use of prescribing data. These records are also an important tool in clinical trial recruitment, allowing doctors who are treating targeted patient populations to focus their efforts.
According to the American Medical Association (AMA), “Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others.†In July, the AMA launched a new web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.
The safeguards offered by the AMA’s program offer a much more reasonable and targeted approach to protecting both patients and physicians from unwanted disclosures. And those safeguards come with far fewer unintended consequences than any ill-considered state legislation.
Here's the full news story:
http://www.washingtonpost.com/wp-dyn/content/article/2007/04/12/AR2007041201208.html
While physician-prescribing data shouldn’t be available for marketing purposes minus physician knowledge and consent, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.
When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor†letters to the physicians who have prescribed the drug in question. This is accomplished quickly and precisely because the industry has access to accurate data. And when safety issues arise, that same data helps define the scope of the problem. Because of this data, for example, the FDA can determine how many patients were taking a specific drug and for how long each patient had been taking it.
Further, FDA-mandated risk management plans — developed for physicians who prescribe higher-risk therapies — are physician-targeted through the use of prescribing data. These records are also an important tool in clinical trial recruitment, allowing doctors who are treating targeted patient populations to focus their efforts.
According to the American Medical Association (AMA), “Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others.†In July, the AMA launched a new web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.
The safeguards offered by the AMA’s program offer a much more reasonable and targeted approach to protecting both patients and physicians from unwanted disclosures. And those safeguards come with far fewer unintended consequences than any ill-considered state legislation.
Liberal bloggers on health care who?
The wonderful proliferation of blogs devoted to health care in general and pharmaceuticals in particular begs the question -- who's doing it?
Just came across a good study by the Institute for Politics, Democracy & the Internet (a part of the George Washington University Graduate School of Political Management).
Many interesting factoids on the issue of political blogs and their readership. Not a lot on health care specifically, but some data did pop out:
* Daily political blog readers are disproportionately "Strong Democrat" and "Strong Liberal."
* Of Democrats who read political blogs daily, 72% agree "strongly" that "Government should provide health insurance for the uninsured." For Democrats who are not daily political blog readers, that number is 53%.
* Same question for Republicans returns a 5% "strongly agree" for political blog readers and 6% for all others.
Perhaps one take-away is that the growing number of health care blogs represent the Democrat "ownership" of the blogosphere. Indeed the study opines that "Some observers have pointed out that conservatives appear to dominate in talk radio while liberals have a greater presence in political blogs."
Ergo, the more blogs on health care and health care related issues (such as the FDA, MMA, Evidence-Based Medicine, etc.) the more disproportionate the liberal (read "anti-Pharma") voice.
Here's a link to the complete report:
http://www.ipdi.org/UploadedFiles/The%20Audience%20for%20Political%20Blogs.pdf
And certainly grist for the mill for those in Big Pharma who don't think they should enter the fray.
As far as I'm concerned -- the more the better.
The wonderful proliferation of blogs devoted to health care in general and pharmaceuticals in particular begs the question -- who's doing it?
Just came across a good study by the Institute for Politics, Democracy & the Internet (a part of the George Washington University Graduate School of Political Management).
Many interesting factoids on the issue of political blogs and their readership. Not a lot on health care specifically, but some data did pop out:
* Daily political blog readers are disproportionately "Strong Democrat" and "Strong Liberal."
* Of Democrats who read political blogs daily, 72% agree "strongly" that "Government should provide health insurance for the uninsured." For Democrats who are not daily political blog readers, that number is 53%.
* Same question for Republicans returns a 5% "strongly agree" for political blog readers and 6% for all others.
Perhaps one take-away is that the growing number of health care blogs represent the Democrat "ownership" of the blogosphere. Indeed the study opines that "Some observers have pointed out that conservatives appear to dominate in talk radio while liberals have a greater presence in political blogs."
Ergo, the more blogs on health care and health care related issues (such as the FDA, MMA, Evidence-Based Medicine, etc.) the more disproportionate the liberal (read "anti-Pharma") voice.
Here's a link to the complete report:
http://www.ipdi.org/UploadedFiles/The%20Audience%20for%20Political%20Blogs.pdf
And certainly grist for the mill for those in Big Pharma who don't think they should enter the fray.
As far as I'm concerned -- the more the better.
People keep telling me that the only major difference between the "first 100 hours" House bill on the abolition of non-interference and the Senator Baucus' pending piece of legislation is that the the House bill says that the Secretary "shall" and the Baucus bill says that the Secretary "can."
No matter how you look at it, it's still momentum in the wrong direction. As Senator John Kyl commented, “I think that Chairman Baucus is in a difficult position. I think he's being required by his caucus to fulfill a campaign promise which is not very wise or popular. We've reduced costs and prices dramatically by the [MMA]. We don't need to mess it up by having direct negotiation by the U.S. government.â€
Well said,but there's something else -- comparative effectiveness.
Senator Baucus' bill (which I have not seen -- so my comments here are based on what I've heard) would also require HHS to set comparative effectiveness priorities without mandating additional ressearch. In other words, comparative effectiveness based on existing RCTs.
Another example of evidence-based medicine being hijacked by cost-based medicine -- while patient-centric care goes unnoticed and unheeded.
How about a bill that would fund research into adaptive clinical trial design and the development of gene tests for the purpose of getting the right medicine in the right dose to the right patient at the right time?
No matter how you look at it, it's still momentum in the wrong direction. As Senator John Kyl commented, “I think that Chairman Baucus is in a difficult position. I think he's being required by his caucus to fulfill a campaign promise which is not very wise or popular. We've reduced costs and prices dramatically by the [MMA]. We don't need to mess it up by having direct negotiation by the U.S. government.â€
Well said,but there's something else -- comparative effectiveness.
Senator Baucus' bill (which I have not seen -- so my comments here are based on what I've heard) would also require HHS to set comparative effectiveness priorities without mandating additional ressearch. In other words, comparative effectiveness based on existing RCTs.
Another example of evidence-based medicine being hijacked by cost-based medicine -- while patient-centric care goes unnoticed and unheeded.
How about a bill that would fund research into adaptive clinical trial design and the development of gene tests for the purpose of getting the right medicine in the right dose to the right patient at the right time?
In 2002, Oxfam International announced a boycott of Israeli goods grown or manufactured in what its literature refers to as the "occupied territories." Last year it blamed Tony Blair for his one sided support of Israel in it's war against Hezbollah. Now of course it supports the Thai dictatorship's effort to seize the IP of drug companies even as they give away free drugs to poor countries.
Just my effort to maintain moral clarity.
Just my effort to maintain moral clarity.
an interesting study about one of a new wave of vaccines for influenza. I am glad to see the move starting away from egg-based technologies to more genetic technologies. It will enable us to respond to an emerging virus rather than have to anticipate one. I am quoted accurately on this here in the HealthDay piece about it:
http://www.forbes.com/forbeslife/health/feeds/hscout/2007/04/10/hscout603589.html
http://www.forbes.com/forbeslife/health/feeds/hscout/2007/04/10/hscout603589.html
Catch the last episode of "The Sopranos?" Yeah, the one where Tony and crew go to Canada and discuss how they can make a pile of dough by importing fake/expired Fosamax.
Could James Gandolfini be positioning himself as the next actor to turn politician? After all, since everyone seems to support pols who support "drugs from Canada," his odds for election might be pretty good.
Perhaps the next step will be to see if he's called by the HELP committee to testify on whether or not importation should be written into PDUFA IV.
Bada Bing!
We'll keep a drugwonks eye on Mr. Gandolfini's activities -- cautiously.
Could James Gandolfini be positioning himself as the next actor to turn politician? After all, since everyone seems to support pols who support "drugs from Canada," his odds for election might be pretty good.
Perhaps the next step will be to see if he's called by the HELP committee to testify on whether or not importation should be written into PDUFA IV.
Bada Bing!
We'll keep a drugwonks eye on Mr. Gandolfini's activities -- cautiously.
On April 9th the New York Times editorial page weighed on the issue of subsidized contraception for university students:
“For almost 20 years, college health centers have been able to purchase contraceptives at nominal prices. This was not a tax-funded subsidy. It was a financial incentive that gave drug manufacturers an exemption from Medicaid pricing rules so they could sell contraceptives and other products to certain charitable groups, like the college clinics, at an extreme discount. In response to concerns that drug companies were abusing this privilege, language was sewn into legislation in 2005 to close a loophole. It also inadvertently slashed this important benefit for clinics and their patients.â€
“On some college campuses, the price of brand-name contraceptives has risen from the neighborhood of $5 per month to $40 or even $50. Switching to a generic is an option in some cases, but it can still entail a 300 percent price increase. Generics often run at about $15 per month. Newer contraceptives, like the NuvaRing, which contains a very low hormone dose and does not require a daily action that is easily forgotten, are not yet available generically. Many students are priced out of the market.â€
“The spike in price affects more than just consumers of contraceptive devices and pills. College and university health clinics sold these products for a small profit — buying them at, say, $3 and selling them at $5. Even on a small campus, these dollars add up quickly. The money was an important part of health center operating budgets, paying for classes and even subsidizing more expensive medications.â€
“The Centers for Medicare and Medicaid Services could reapply these exemptions with the stroke of a pen. If they do not, Congress should restore this much-needed benefit.â€
Spot the inconsistency?
How can you be FOR a government program that provides access to new (and more expensive) treatments (like the NuvaRing) while at the same time being FOR a piece of legislation that would create restrictive formularies that would deny access to new (and more expensive) treatments (like on-patent statins)?
This is the same editorial page that is all gung-ho in support of reversing the non-interference clause and embracing comparative effectiveness measures. It seems that the Gray Lady considers contraception more important than cholesterol.
But you can’t have it both ways.
Further, when government dictates prices, what also goes by the boards is the incentive to develop new products at all.
But, when it comes to contraception, it seems there isn't any such thing as a "me too" product.
(And there isn't.)
“For almost 20 years, college health centers have been able to purchase contraceptives at nominal prices. This was not a tax-funded subsidy. It was a financial incentive that gave drug manufacturers an exemption from Medicaid pricing rules so they could sell contraceptives and other products to certain charitable groups, like the college clinics, at an extreme discount. In response to concerns that drug companies were abusing this privilege, language was sewn into legislation in 2005 to close a loophole. It also inadvertently slashed this important benefit for clinics and their patients.â€
“On some college campuses, the price of brand-name contraceptives has risen from the neighborhood of $5 per month to $40 or even $50. Switching to a generic is an option in some cases, but it can still entail a 300 percent price increase. Generics often run at about $15 per month. Newer contraceptives, like the NuvaRing, which contains a very low hormone dose and does not require a daily action that is easily forgotten, are not yet available generically. Many students are priced out of the market.â€
“The spike in price affects more than just consumers of contraceptive devices and pills. College and university health clinics sold these products for a small profit — buying them at, say, $3 and selling them at $5. Even on a small campus, these dollars add up quickly. The money was an important part of health center operating budgets, paying for classes and even subsidizing more expensive medications.â€
“The Centers for Medicare and Medicaid Services could reapply these exemptions with the stroke of a pen. If they do not, Congress should restore this much-needed benefit.â€
Spot the inconsistency?
How can you be FOR a government program that provides access to new (and more expensive) treatments (like the NuvaRing) while at the same time being FOR a piece of legislation that would create restrictive formularies that would deny access to new (and more expensive) treatments (like on-patent statins)?
This is the same editorial page that is all gung-ho in support of reversing the non-interference clause and embracing comparative effectiveness measures. It seems that the Gray Lady considers contraception more important than cholesterol.
But you can’t have it both ways.
Further, when government dictates prices, what also goes by the boards is the incentive to develop new products at all.
But, when it comes to contraception, it seems there isn't any such thing as a "me too" product.
(And there isn't.)
Let's get real -- a system in which a federal PBM "competes" with private-sector PBMs is unworkable and, over time, would result in a dysfunctional government monopoly.
PBMJ = Prescription Benefit Misjudgment.
At the most obvious level, some of the costs of a federal PBM would, inevitably, be hidden in other budgets -- the Social Security budget, the HHS budget, the catch-all budget for government office space, the pro-rated share of interest on the national debt, ad infinitum -- so that there would be a cost bias in favor of the federal PBM, except to the extent that federal agencies systematically operate less efficiently than private firms.
At a more subtle level, since the federal government has powerful incentives to emphasize budget savings over formulary expansion, the mythic federal PBM would attract relatively healthy seniors and/or those who disproportionately use less-expensive medicines and are willing to accept sharp formulary limits in exchange for lower premiums.
Private sector PBMs, because of a standard econometric adverse selection process would, obviously, attract those seniors who anticipate the need for more expensive medicines and, therefore, desire broader formularies; and an increase in the premiums charged by the private PBMs would exacerbate the problem by further concentrating high-cost seniors in the private PBM market.
This is quite apart from the problems created by a subsidy formula based on "average" premiums. The end result would be a market without the private PBMs, that is, monopolized by the mythic federal PBM.
Net/Net: a back-door route toward a VA-type pricing system.
Thanks to economist extraordinare Ben Zycher for the deep dive on PBM-land.
PBMJ = Prescription Benefit Misjudgment.
At the most obvious level, some of the costs of a federal PBM would, inevitably, be hidden in other budgets -- the Social Security budget, the HHS budget, the catch-all budget for government office space, the pro-rated share of interest on the national debt, ad infinitum -- so that there would be a cost bias in favor of the federal PBM, except to the extent that federal agencies systematically operate less efficiently than private firms.
At a more subtle level, since the federal government has powerful incentives to emphasize budget savings over formulary expansion, the mythic federal PBM would attract relatively healthy seniors and/or those who disproportionately use less-expensive medicines and are willing to accept sharp formulary limits in exchange for lower premiums.
Private sector PBMs, because of a standard econometric adverse selection process would, obviously, attract those seniors who anticipate the need for more expensive medicines and, therefore, desire broader formularies; and an increase in the premiums charged by the private PBMs would exacerbate the problem by further concentrating high-cost seniors in the private PBM market.
This is quite apart from the problems created by a subsidy formula based on "average" premiums. The end result would be a market without the private PBMs, that is, monopolized by the mythic federal PBM.
Net/Net: a back-door route toward a VA-type pricing system.
Thanks to economist extraordinare Ben Zycher for the deep dive on PBM-land.
This from Biocentury which I thought was a send up or parody of the extremes to which the FDA would have to go or bottoms of the barrels to which they would have to scrape -- you can choose your image -- in a search for untainted members or at least bias balance rather than just finding the best scientific minds to determine the risks and benefits of a medicine:
Arcoxia COI disclosures
The FDA advisory panel committee to review Arcoxia etoricoxib from Merck (MRK) this week has been granted three conflict of interest waivers to academics with commercial ties. The panel also will include two consumer advocates as voting members who have taken public stances against COX-2 drugs but do not require COI waivers under the agency's rules.
"Diane Aronson, the Arthritis Advisory Committee's voting consumer representative, is president of the Road Back Foundation, an organization dedicated solely to advocating the use of antibiotics to treat arthritis, an indication that has not been approved by FDA.
Arthur Levin, a temporary voting member, is director of the Center for Medical Consumers. The center is a participant in the Prescription Access Litigation Project (PAL), which has lawsuits pending against MRK alleging deceptive advertising of Vioxx and a similar suit against Pfizer (PFE) related to Celebrex.
The COI waiver participants include temporary voting member Robert Levine of the State University of New York, who reported ownership of $25,000-$50,000 in MRK stock.
A permanent member, Kenneth Saag of the University of Alabama at Birmingham, received $10,000-$50,000 in the last year as a member of MRK's speaker's bureau for topics unrelated to the meeting and received less than $10,000 from each of two competing companies for consulting unrelated to the meeting.
The University of Washington's Dennis Turk, who will chair Thursday's meeting, received less than $10,000 over the last year for participating on the advisory board of a company that competes with MRK.
According to Levin, the Center for Medical Consumers does not have a financial interest in PAL's litigation against MRK or PFE. "Everyone comes to the meeting with some kind of bias. The best way to deal with it is make sure that any one bias isn't over-represented," he told BioCentury. Nevertheless, Levin said, FDA should not have issued the Arcoxia waivers given controversy over a February 2005 meeting on COX-2 safety.
The three academics would be precluded from voting under new COI guidelines recently proposed by FDA. But Levin and Aronson would not need waivers under either scheme."
So let me get this straight: someone who is suing drug companies regarding the very safety issues that the Adcom will present and a patient who pushing a very different approach to an entirely different disease (RA as opposed to OA) are entitled to weigh in but not everyone else?
We have lost our moral compass on the issue of drug safety. By Levin's definition no one who receives money from companies for any reason can be trusted to engage in scientific enterprises or make a professional judgment that impacts individual or societal health while people who do not take money for companies but who nonetheless are biased in their own ways are therefore entitled to do so?
The Adcom composition is a glimpse of what will be left of the scientific enterprise and decisors if we keep going down this road. The litigators and junk scientists on the one hand and the scientific Stalinists like Marcia Angell, Jerry Avorn, Relman and the rest on the other.... All funded by George Soros and trial attorneys.
Arcoxia COI disclosures
The FDA advisory panel committee to review Arcoxia etoricoxib from Merck (MRK) this week has been granted three conflict of interest waivers to academics with commercial ties. The panel also will include two consumer advocates as voting members who have taken public stances against COX-2 drugs but do not require COI waivers under the agency's rules.
"Diane Aronson, the Arthritis Advisory Committee's voting consumer representative, is president of the Road Back Foundation, an organization dedicated solely to advocating the use of antibiotics to treat arthritis, an indication that has not been approved by FDA.
Arthur Levin, a temporary voting member, is director of the Center for Medical Consumers. The center is a participant in the Prescription Access Litigation Project (PAL), which has lawsuits pending against MRK alleging deceptive advertising of Vioxx and a similar suit against Pfizer (PFE) related to Celebrex.
The COI waiver participants include temporary voting member Robert Levine of the State University of New York, who reported ownership of $25,000-$50,000 in MRK stock.
A permanent member, Kenneth Saag of the University of Alabama at Birmingham, received $10,000-$50,000 in the last year as a member of MRK's speaker's bureau for topics unrelated to the meeting and received less than $10,000 from each of two competing companies for consulting unrelated to the meeting.
The University of Washington's Dennis Turk, who will chair Thursday's meeting, received less than $10,000 over the last year for participating on the advisory board of a company that competes with MRK.
According to Levin, the Center for Medical Consumers does not have a financial interest in PAL's litigation against MRK or PFE. "Everyone comes to the meeting with some kind of bias. The best way to deal with it is make sure that any one bias isn't over-represented," he told BioCentury. Nevertheless, Levin said, FDA should not have issued the Arcoxia waivers given controversy over a February 2005 meeting on COX-2 safety.
The three academics would be precluded from voting under new COI guidelines recently proposed by FDA. But Levin and Aronson would not need waivers under either scheme."
So let me get this straight: someone who is suing drug companies regarding the very safety issues that the Adcom will present and a patient who pushing a very different approach to an entirely different disease (RA as opposed to OA) are entitled to weigh in but not everyone else?
We have lost our moral compass on the issue of drug safety. By Levin's definition no one who receives money from companies for any reason can be trusted to engage in scientific enterprises or make a professional judgment that impacts individual or societal health while people who do not take money for companies but who nonetheless are biased in their own ways are therefore entitled to do so?
The Adcom composition is a glimpse of what will be left of the scientific enterprise and decisors if we keep going down this road. The litigators and junk scientists on the one hand and the scientific Stalinists like Marcia Angell, Jerry Avorn, Relman and the rest on the other.... All funded by George Soros and trial attorneys.
Rule Britainia? Time to change the rule.
From today's edition of the London Daily Mail, another example of so-called "evidence-based medicine" focusing on saving costs rather than saving lives.
Cut-price statins linked to increase in patient deaths
By RHODRI PHILLIPS
10th April 2007
Health chiefs are reviewing evidence which apparently shows a link between a cut-price statin and an increased risk of death among heart patients.
The drug, simvastatin, is taken by more than a million people to combat high cholesterol. Doctors were advised in January last year to prescribe it instead of more expensive atorvastatin.
But analysis carried out at University Hospital of North Staffordshire in Stoke-on-Trent shows that three times more patients on the cheaper drug died compared to those taking atorvastatin a year earlier. In the three months from December 2004 to February 2005, five out of 100 patients - or five per cent - prescribed atorvastatin died. But 20 of 121 patients - 17 per cent - on simvastatin died between December 2005 and February 2006.
Now the National Institute for Health and Clinical Excellence (NICE) is reviewing the use of simvastatin.
Dr Giri Rajaratnam, Stoke-on-Trent's public health director said: "NICE are doing a full-scale review of statins, looking at the balance between safety and effectiveness and severity of illness."
Two million people in Britain take statins to lower their cholesterol and help protect against the risk of stroke or heart attack. Since simvastatin was introduced three years ago as a cheaper option, 60 per cent have made the switch.
NICE, which advises NHS trusts on the use of drugs, said a 28-day course of simvastatin given to patients in 40mg doses, costing £3.57, was the equivalent to a 28-day course of 10mg atorvastatin tablets, costing £18.03.
Last year the British Medical Journal predicted the NHS could save £2billion within five years if doctors prescribe the cheaper drug. Simvastatin can be bought over the counter, while atorvastatin is only available on prescription.
Cardiologist Dr Rob Butler, who carried out the research, said: "A decision was taken between the local primary care trusts and the local National Health Service trust to switch to generic simvastatin.
"We decided to audit the effects. We were principally looking for differences in numbers of patients needing to be readmitted following discharge. But we were surprised when we saw such a difference in the death rate."
Dr Butler, who has previously received payment from a number of drugs companies, including Pfizer - which makes atorvastatin under the brand name Lipitor - also noticed more patients returning to hospital for further treatment after using simvastatin.
Dr Rajaratnam has also ordered a review into the statin drugs following Dr Butler's research. However, simvastatin is still being used.
A joint statement issued by the hospital and Stoke-on-Trent Primary Care Trust last week said their policy on statin use was consistent with NICE guidance.
It added: "To determine whether our policy should be amended in light of further evidence, the health economics unit at Birmingham University will consider whether any sub-groups of patients would benefit from intensification of their statin treatment.
"The North Staffordshire guideline will be reviewed in the light of its results."
The NICE advice published in January 2006 advised doctors to prescribe simvastatin as a first resort but to use their judgment if they thought another drug such as atorvastatin was more appropriate.
From today's edition of the London Daily Mail, another example of so-called "evidence-based medicine" focusing on saving costs rather than saving lives.
Cut-price statins linked to increase in patient deaths
By RHODRI PHILLIPS
10th April 2007
Health chiefs are reviewing evidence which apparently shows a link between a cut-price statin and an increased risk of death among heart patients.
The drug, simvastatin, is taken by more than a million people to combat high cholesterol. Doctors were advised in January last year to prescribe it instead of more expensive atorvastatin.
But analysis carried out at University Hospital of North Staffordshire in Stoke-on-Trent shows that three times more patients on the cheaper drug died compared to those taking atorvastatin a year earlier. In the three months from December 2004 to February 2005, five out of 100 patients - or five per cent - prescribed atorvastatin died. But 20 of 121 patients - 17 per cent - on simvastatin died between December 2005 and February 2006.
Now the National Institute for Health and Clinical Excellence (NICE) is reviewing the use of simvastatin.
Dr Giri Rajaratnam, Stoke-on-Trent's public health director said: "NICE are doing a full-scale review of statins, looking at the balance between safety and effectiveness and severity of illness."
Two million people in Britain take statins to lower their cholesterol and help protect against the risk of stroke or heart attack. Since simvastatin was introduced three years ago as a cheaper option, 60 per cent have made the switch.
NICE, which advises NHS trusts on the use of drugs, said a 28-day course of simvastatin given to patients in 40mg doses, costing £3.57, was the equivalent to a 28-day course of 10mg atorvastatin tablets, costing £18.03.
Last year the British Medical Journal predicted the NHS could save £2billion within five years if doctors prescribe the cheaper drug. Simvastatin can be bought over the counter, while atorvastatin is only available on prescription.
Cardiologist Dr Rob Butler, who carried out the research, said: "A decision was taken between the local primary care trusts and the local National Health Service trust to switch to generic simvastatin.
"We decided to audit the effects. We were principally looking for differences in numbers of patients needing to be readmitted following discharge. But we were surprised when we saw such a difference in the death rate."
Dr Butler, who has previously received payment from a number of drugs companies, including Pfizer - which makes atorvastatin under the brand name Lipitor - also noticed more patients returning to hospital for further treatment after using simvastatin.
Dr Rajaratnam has also ordered a review into the statin drugs following Dr Butler's research. However, simvastatin is still being used.
A joint statement issued by the hospital and Stoke-on-Trent Primary Care Trust last week said their policy on statin use was consistent with NICE guidance.
It added: "To determine whether our policy should be amended in light of further evidence, the health economics unit at Birmingham University will consider whether any sub-groups of patients would benefit from intensification of their statin treatment.
"The North Staffordshire guideline will be reviewed in the light of its results."
The NICE advice published in January 2006 advised doctors to prescribe simvastatin as a first resort but to use their judgment if they thought another drug such as atorvastatin was more appropriate.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
