Latest Drugwonks' Blog
Some people will not take "yes" for an answer....
The results of the RECORD study would seem to vindicate the use of Avandia as a treatment option for diabetes patients seeking to maintain glycemic control and reduce the risk of death from cardiovascular disease....
RECORD: No overall increase in CV risk with rosiglitazone
American Diabetes Association's 69th Scientific Sessions
Rosiglitazone was not associated with an increased risk for overall cardiovascular morbidity or mortality compared with standard glucose-lowering therapies, according to the final analysis data of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study.
At 5.5 years, the primary outcome – first occurrence of CV death or hospitalization – was equivalent (14.5%) in patients assigned to rosiglitazone (Avandia, GlaxoSmithKline) or metformin and sulfonylurea, according to Philip D. Home, DM, DPhil, chairman of the RECORD Steering Committee and professor of diabetes medicine at Newcastle University, UK. The researchers reported 321 events among patients assigned rosiglitazone as add-on therapy and 323 events among patients assigned metformin or sulfonylurea only (HR=0.99; 95% CI, 0.85-1.16).
“Overall, in CV terms, the drug is safe. Would rosiglitazone meet current FDA criteria as a safe drug in diabetes? The answer to that is yes,” Home said during a press conference on Friday.
The RECORD study was designed to evaluate the long-term effect of rosiglitazone on CV outcomes and blood glucose control compared with metformin and sulfonylureas. The open-label study was conducted at 338 centers in 23 countries in Europe, Australia and New Zealand. The researchers randomly assigned 4,447 patients with type 2 diabetes who were already on metformin or sulfonylurea monotherapy to either add-on rosiglitazone (n=2,220) or a combination of metformin and sulfonylurea (n=2,227). All doses were progressively increased toward achieving and maintaining a target HbA1c of <7%. If HbA1c rose to 8.5% or more, either a third oral glucose-lowering drug was added (for rosiglitazone group) or insulin was started (for active control group).
Click here to read the full article.
So How do we explain this headline?
RECORD results: rosiglitazone doubles risk of heart failure, fractures
The much-anticipated results of the Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes (RECORD) trial seem destined to become yet another element in the agent’s controversial history.
Although rosiglitazone did not increase overall cardiovascular hospitalizations or deaths compared with metformin and sulfonylurea, the risk of heart failure doubled among patients taking rosiglitazone, and there were increased heart failure deaths, reports Philip D. Home, DM, chairman of the RECORD steering committee and Professor of Diabetes Medicine, Newcastle University, UK (pictured above).
And another point. Steve Nissen admitted, in the face of the RECORD evidence, that his initial meta-analysis might be inaccurate…
There were too few incidences of myocardial infarction and MI death among RECORD patients to detect a significant association with rosiglitazone. "I agree with the authors," says Steven Nissen, MD, chairman, Department of Cardiovascular Medicine, Cleveland Clinic. "The results of RECORD are inconclusive with respect to the effects of the drug on the risk of heart attack."
Dr. Nissen points out, however, that in the subgroup of RECORD patients with preexisting heart disease, there was a 26% increase (p=0.055) in MI.
Click here to read the full article.
I should point out, however, that Nissen’s meta-analysis swept everyone who used Avandia into his data pool to get his increase of risk (43 percent). Of course 26 percent is less than 43 percent.
Meanwhile, what havoc and public health impact was caused by the fearmongering…?
The results of the RECORD study would seem to vindicate the use of Avandia as a treatment option for diabetes patients seeking to maintain glycemic control and reduce the risk of death from cardiovascular disease....
RECORD: No overall increase in CV risk with rosiglitazone
Adverse findings include increased risk for fracture in women, heart failure
Posted on June 6, 2009
American Diabetes Association's 69th Scientific SessionsRosiglitazone was not associated with an increased risk for overall cardiovascular morbidity or mortality compared with standard glucose-lowering therapies, according to the final analysis data of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study.
At 5.5 years, the primary outcome – first occurrence of CV death or hospitalization – was equivalent (14.5%) in patients assigned to rosiglitazone (Avandia, GlaxoSmithKline) or metformin and sulfonylurea, according to Philip D. Home, DM, DPhil, chairman of the RECORD Steering Committee and professor of diabetes medicine at Newcastle University, UK. The researchers reported 321 events among patients assigned rosiglitazone as add-on therapy and 323 events among patients assigned metformin or sulfonylurea only (HR=0.99; 95% CI, 0.85-1.16).
“Overall, in CV terms, the drug is safe. Would rosiglitazone meet current FDA criteria as a safe drug in diabetes? The answer to that is yes,” Home said during a press conference on Friday.
The RECORD study was designed to evaluate the long-term effect of rosiglitazone on CV outcomes and blood glucose control compared with metformin and sulfonylureas. The open-label study was conducted at 338 centers in 23 countries in Europe, Australia and New Zealand. The researchers randomly assigned 4,447 patients with type 2 diabetes who were already on metformin or sulfonylurea monotherapy to either add-on rosiglitazone (n=2,220) or a combination of metformin and sulfonylurea (n=2,227). All doses were progressively increased toward achieving and maintaining a target HbA1c of <7%. If HbA1c rose to 8.5% or more, either a third oral glucose-lowering drug was added (for rosiglitazone group) or insulin was started (for active control group).
Click here to read the full article.
So How do we explain this headline?
RECORD results: rosiglitazone doubles risk of heart failure, fractures
Publish date: Jun 6, 2009
By: Maude L. Campbell, Clinical Managing Editor
The much-anticipated results of the Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes (RECORD) trial seem destined to become yet another element in the agent’s controversial history.Although rosiglitazone did not increase overall cardiovascular hospitalizations or deaths compared with metformin and sulfonylurea, the risk of heart failure doubled among patients taking rosiglitazone, and there were increased heart failure deaths, reports Philip D. Home, DM, chairman of the RECORD steering committee and Professor of Diabetes Medicine, Newcastle University, UK (pictured above).And another point. Steve Nissen admitted, in the face of the RECORD evidence, that his initial meta-analysis might be inaccurate…
There were too few incidences of myocardial infarction and MI death among RECORD patients to detect a significant association with rosiglitazone. "I agree with the authors," says Steven Nissen, MD, chairman, Department of Cardiovascular Medicine, Cleveland Clinic. "The results of RECORD are inconclusive with respect to the effects of the drug on the risk of heart attack."
Dr. Nissen points out, however, that in the subgroup of RECORD patients with preexisting heart disease, there was a 26% increase (p=0.055) in MI.
Click here to read the full article.
I should point out, however, that Nissen’s meta-analysis swept everyone who used Avandia into his data pool to get his increase of risk (43 percent). Of course 26 percent is less than 43 percent.
Meanwhile, what havoc and public health impact was caused by the fearmongering…?
Four years later, David Himmelstein, Steffie Woolhandler, Elizabeth Warren, and Deborah Thorne are back. Last week they published a new analysis in The American Journal of Medicine. Now they say that 62.1 percent of bankruptcies in 2007 were “medical” in origin. But what they have really done is engaged in goal post shifting and misdirection.
Himmelstein et al. have extended the study from five states to the whole US but use a sample that was self-selecting. They sent questionnaires to 4976 debtors and received 2314 fully filled out (46.5 percent). A full 49.3 percent didn’t answer at all. Telephone interviews and analysis of court records then followed on some of these debtors.
Although the authors tried to check whether the respondents were representative, they could not control for the most important factor, medical debt. As the content of the questionnaire almost certainly betrayed their specific interest in health costs, debtors who were willing to participate may have been more likely to have such bills and/or believe they were a factor in the bankruptcy.
To expand their 2005 study, Himmelstein et al. applied the same criteria. This includes not only the 29 percent who cited health care costs (itself a self-report) but also those “reporting uncovered medical bills > $1000 in the past 2 years” (emphasis mine), losing two weeks of income from their job due to being sick or hurt (or had to leave their job, a criteria change from 2005), or mortgaging their house to cover medical debt. They consider this definition to be “conservative” (excuse me while I go laugh).
Further, “[d]ebtors who gave no answers regarding reasons for their bankruptcy were excluded from analyses,” i.e. the authors took out of the sample a large number of people who didn’t have medical debts or didn’t consider them a cause.
Himmelstein et al. do use a different threshold for uncovered costs of $5000 or 10 percent of family income for some analyses but do not distinguish clearly when each limit is being used. Further, estimates of the average health care costs of Americans in 2006 and 2007 put them at 6 to 10 percent of family income (based on a family plan and an income of $58,526). No surprise then that 34.7 percent of the debtors in the study met this threshold, especially since their sample has an average monthly income of $2676 or about $32,000 annually (median $2299/~$27,600), low for being considered middle class.
As for the two weeks of lost income criterion, well, it has always bothered me and not just because it over-represents certain types of jobs and doesn’t look at the debtor’s overall finances. Rather I wonder why this is considered a problem of the health care system. The authors haven’t put forth an argument that better care would have avoided or mitigated time out of work but instead seem to want a greater subsidization of those unable to work for whatever reason, an impression heightened by the fact that they then throw in income lost to care for someone who was sick as a criterion for medical bankruptcy. Whatever the value of such a policy, it is a question of broader social policies, not of the health system itself.
Himmelstein et al. go on to gloss over the many factors that distinguish so-called medical bankruptcies from non-medical ones, and which have obvious ramifications for increasing health costs. The debtors are slightly older (44.9 vs. 43.3 years), are more likely to be married (46.3 vs. 40.1 percent), and had a slightly larger average family size (2.79 vs. 2.63 people). All were statistically significant (p-values were .01, .02, .02). Also, they were more likely have had a break in insurance coverage in the last two years (40 vs. 34.1 percent, p=.005).
The authors claimed the debtors were middle-class based on “occupational prestige,” not income, and those with medical bankruptcies actually had lower scores in this area (86.1 percent with scores over 20 vs. 89.8 percent, p=.01). Further, they had lower incomes (mean/median monthly income = $2586/$2225 vs. $2851/$2478, p=.002) and were less likely to have a spouse who was employed (75.5 vs. 85 percent, p=.001). Their homes were also worth less ($141,861 vs. $159,145, p=.03).
Finally, Himmelstein et al. have again failed to take even a cursory look at the other bills and financial stresses or the level of overall debt.
None of this is to say that medical bills don’t play a role in some bankruptcies, perhaps even providing the final straw. Himmelstein et al. are coy, they never actually state that these bankruptcies are caused by medical bills but the authors are happy to opine to the press, knowing that the public will hear the scare story, not the reality. Oh, and guess what? There were fewer bankruptcies in 2007 than in 2001 – and fewer medical bankruptcies, however you define them. But shhhhh…it’s a secret.
Let's see... new drug development is at an all time low and the FDA is faced with new responsiblities in tracking the safety of generics being produced from China, counterfeit products, tainted goods, the possiblity of developing new standards for follow on biologics...all in the name of safety.
So the reasonable thing to do is...make it harder for the FDA to track a flood of products from other countries with shady track records?
Of course. Which is why drug reimportation has been reintroduced. Since Congress doesn't really care about drug safety -- except when it comes to hearings -- the legislation designed to make it legal to tranship adulterated and counterfeit drugs through Canada and Europe (read the bill) is now attached to a piece of legislation that would give the FDA the authority to regulate tobacco. (Just what we need, FDA approved Cuban cigars stinking up America.)
See this link to the In Vivo blog about drug running and get the whole story...
So the reasonable thing to do is...make it harder for the FDA to track a flood of products from other countries with shady track records?
Of course. Which is why drug reimportation has been reintroduced. Since Congress doesn't really care about drug safety -- except when it comes to hearings -- the legislation designed to make it legal to tranship adulterated and counterfeit drugs through Canada and Europe (read the bill) is now attached to a piece of legislation that would give the FDA the authority to regulate tobacco. (Just what we need, FDA approved Cuban cigars stinking up America.)
See this link to the In Vivo blog about drug running and get the whole story...
In an era of personalized medicine we can and must do better than just shoving people into taking the cheapest drug and then seeing if people slip in convulsions. Ultimately many more drugs are going to to go generic so treatment selection will still be an issue and so will the attendant costs.
NOT WHAT THE DOCTOR ORDERED
The Detroit Free Press
By Patricia Anstett 6/5/2009 5:30 AM
Busy with other chores, Kathryn Pauley asked her 16-year-old to pick up younger daughter Cheyenne 's seizure medicine at a pharmacy.To her surprise, Pauley found a generic drug, not Lamictal, a brand-name drug that had effectively controlled most of Cheyenne 's seizures. In the next week, Cheyenne , 11, had 21 seizures -- many more than usual.
The switch occurred even though Cheyenne 's doctor had written "dispense as written," or DAW, on the prescription. Cheyenne 's Medicaid policy refused to fill the prescription until her doctor challenged it, said Pauley of Belleville.
A fierce legislative campaign is playing out in Michigan and other states over generic substitution and therapeutic switching, a practice that allows health insurers to fill a prescription with drugs similar to brand-name drugs.
Usually, a doctor can stop a switch by writing DAW on a prescription. But problems still can occur and appeals are time-consuming.
James McCurtis, a spokesman for Michigan 's Medicaid program, said the state prefers to use money-saving generics when possible. Doctors can apply through a process called prior authorization to get a brand-name drug for a patient, but McCurtis acknowledged that process may be time-consuming.
The Michigan Osteopathic Association and the Michigan Association of Family Physicians want changes to ensure consumers are alerted about prescription changes. Health plans and the Michigan Pharmacists Association see any new laws as unnecessary. Either way, there are important issues for consumers to understand.
Mich. fight over generics heats up
The push to use generic drugs has brought big savings to U.S. health care -- $734 billion over the last decade.
But as much as they support ways to hold down health costs, the 7,000-member Michigan Osteopathic Association and the 3,000-member Michigan Association of Family Physicians have some worries. They're concerned that the preference by many health plans toward generics and nearly-equivalent drugs called therapeutic substitutes leave too many patients and their doctors out of the decision-making about which drug they can prescribe or use.
They want state laws to ban payments and other incentives that health plans and pharmacy benefit management companies use to encourage doctors to prescribe generics and so-called therapeutic equivalents -- drugs like but not identical to brand-name drugs.
Another bill would require a patient's consent before a pharmacy could switch a brand-name epilepsy drug to another drug.
Popularity of generics
The issue is significant as more health plans promote generic drugs and Americans look for savings, particularly as they lose insurance or face higher out-of-pocket co-pays. Generic use has risen from 61% in 2006 to nearly 70% today, according to the Generic Pharmaceuticals Association, in a May report.
"Physicians feel they are being handcuffed more and more," said Dr. Craig Magnatta, president of the Michigan Osteopathic Association.
The osteopathic association has produced a printable, wallet-sized card on its Web site to help patients learn about the issue at
www.michigando.com
Every day, Magnatta, a family practice physician with offices in Rochester Hills and Oxford , and one of his assistants plow through a pile of paperwork with insurance company denials or questions about drugs he prescribed.
Many plans won't pay for many brand-name drugs, at least not initially. Health plans particularly make it difficult to prescribe certain drugs, such as epilepsy medicines, antidepressants, blood thinners, proton pump inhibitors, psychiatric, thyroid, pain and antirejection medicines, he said.
Two bills that address generic issues await action later this year by the Senate Health Policy Committee, which postponed a hearing in May. Committee chair, Sen. Thomas George, R-Kalamazoo, said the bills may be reworked.
Unnecessary action?
Michigan 's health plans and the Michigan Pharmacists Association consider the legislation unnecessary.
Dr. Tom Simmer, senior vice president and chief medical officer of Blue Cross Blue Shield of Michigan, said generics have produced sizeable savings, including as much as $1,000 a year for consumers, at a time when many have no insurance or higher drug co-pays.
Nationwide, generics have saved consumers $734 billion over the last 10 years, according to a report issued in May by the Generic Pharmaceutical Association.
"We're saying, before you jump to the $120 a month antacid, try less costly ones," Simmer said.
As more drugs go generic, brand-name drug manufacturers are spending millions of dollars on direct-to-consumer advertising campaigns that inflate health costs by encouraging consumers to ask their doctors to prescribe brand-name drugs, Simmer said.
Antonio Petitta, vice president of pharmacy care management for the Health Alliance Plan, said he thinks the legislation will add red tape.
"It adds a layer of difficulty to prescribing," she said.
Trouble with epilepsy
Arlene Gorelick, executive director of the Michigan Epilepsy Foundation, which favors the bills, said her group and its national foundation are tracking increased incidence of seizures in people who have had to change to generics and therapeutic equivalents.
"Antiepileptic drugs are very precise and establish a delicate balance for each individual with epilepsy," Gorelick added. "No two medications are alike. Even slight changes can cause ... seizures."
Others point out that groups like the Epilepsy Foundation receive funding from brand-name drugs, a fact Gorelick acknowledges but said did not influence the organization's position on the issue.
"The Epilepsy Foundation of Michigan does receive unrestricted educational grants from pharmaceutical companies and device makers, as well as from hospitals and insurance companies," Gorelick said. "These dollars represent a small percentage of our operating budget."
Bringing down costs
Dr. Rick Smith, president of the Michigan State Medical Society, an 11,000-member physician's organization affiliated with the American Medical Association, said his organization has not taken a position on the bills.
Smith said electronic or E-prescribing systems make it easier to track which drugs health plans pay for or prefer to use first and cut out some of the red tape. He was an early user of generics and electronic medical systems in the Henry Ford Health System, where he's an obstetrician/gynecologist.
Generics are "one of the best ways to bring excessive costs down." But he agrees some drugs such as seizure medicines may not be easily substituted, as the therapeutic range of those and some other drugs is narrower, he said.
Additional Facts Drug legislation
Two bills in the Legislature, supported by two state physician organizations and some patient support groups, address generic substitution and therapeutic switching.
# SB 318 prohibits health plans from making payments or giving other incentives to doctors and other health professional to prescribe certain drugs. It also would require Michigan 's attorney general to report quarterly on any payments or incentives that might be viewed as inducements to prescribe a certain drug.
# HB 4408 bans substitution of brand name epilepsy drugs without the consent of the doctor, patient or legal guardian.
If you’ve been following the health care debate, you’ve probably heard would-be reformers express outrage that half of all bankruptcies in the US are caused by medical bills. But is it true?
Not really. Or rather, only if you accept a number of dubious premises.
Well, what about the sister statistic that that health care costs cause a bankruptcy every 30 seconds?
Nope. Simple math proves that incorrect; the Bankruptcy Data Project at Harvard University shows that from February 2008 through January 2009 there were 1,114,811 bankruptcies of all types, personal and business, or about one every 28 seconds. This is fewer bankruptcies than earlier in the decade but the conclusion remains true even for those years.
In fact, both of these claims are based on an article published in the journal Health Affairs in 2005. It was authored David Himmelstein, Steffie Woolhandler, Elizabeth Warren, and Deborah Thorne. Yesterday, with this post already finished, I found out that they have just published a new article, upping the percentage of medical bankruptcies to 62.1 percent and adding some new methodological problems to the old ones. So today I will take on the 2005 piece and on Monday I will dissect their newest effort.
To reach their conclusions, Himmelstein et al. surveyed 1,771 people who declared bankruptcy in 2001 and asked about the reasons for their bankruptcy. Those citing medical bills as a factor were 28.3 percent of the total. However, to classify even these as medical bankruptcies would ignore the fact that there were other contributors.
But then the authors go on to add to this percentage anyone who meets a series of criteria. For instance, they considered a medical bankruptcy one in which there was $1,000 or more of medical debt, regardless of the source or size of other debts. In other words, if the person has $50,000 of credit card debt and $1,000 owed to a doctor, this counts as a medically precipitated bankruptcy.
These also include debtors who had lost two weeks’ income due to medical problems, but once again, there is no consideration of other debts and factors. Only a small fraction of people would be pushed into bankruptcy by this alone, the vast majority have other large debts or other circumstances that render them vulnerable to bankruptcy if they lose income for any reason.
Finally, Himmelstein et al. say that when costs were incurred for “addiction, or uncontrolled gambling, or birth, or the death of a family member,” it counts as a medical bankruptcy. Addiction and gambling do not belong in this category, the treatment perhaps is a matter for the medical system (or not) but the money spent on these habits certainly isn’t. Why birth and death are singled out is also mysterious; they ought to be treated the same as any condition involving medical care.
In addition, the study is uncontrolled, we know nothing about the families that don’t go bankrupt but may have the same amount of medical debt, and the article tells us the average medical debt of the people who filed for bankruptcy but not the median, so we do not know if this number is skewed by just a few people with very high expenses.
Statistics have failed to show a correlation between national trends in medical costs and bankruptcy statistics or between medically related absence from work and bankruptcy. Both a Legal Aid society study and one from the Department of Justice put medical bills at about 12 percent of what people filing for bankruptcy owed. David Dranove and Michael L. Millenson concluded in a critique of Himmelstein et al. that taking the 28.3 percent who cited illness or injury as a reason for their bankruptcy and the 60 percent of this group who blamed medical bills specifically, the percentage of people for whom medical expenses were a cause of bankruptcy (and not necessarily the only or the largest) is 17 percent.
So much for the myth that medical bankruptcies are overwhelming millions of Americans every year.
Along with the critique by Dranove and Millenson here.
Excellent omnibus article on healthcare in the Age of Obama in this month’s edition of PharmaVoice. It’s titled, “Obamaceuticals” and can be found here.
Instead of prescription drugs, we're now importing single-payer advocates from Canada.
As if we didn’t have enough of the domestic variety already.
Apparently not.
Yesterday, Jack Layton, a Canadian politician and leader of the leftie New Democratic Party, visited DC to speak with Congressional Democrats, White House officials, and to deliver a speech on health care reform at the Woodrow Wilson Center.
The accommodation afforded Jack Layton is especially troubling given the fact that the Obama Administration has refused to involve key Americans policy leaders in the health care reform dialogue. Indeed, the Obama Administration has shunned prominent free-market healthcare policy organizations in March when it held a White House summit on the issue. The Manhattan Institute, the Pacific Research Institute, CMPI, and the Galen Institute, just to name a few, were among the organizations not extended an invite to participate.
We are not amused.
Yet Administration officials and Democratic leaders in Congress have time to meet with a Canadian politician of a non-governing party.
In advance of Mr. Layton’s trip down, the NDP sent a letter announcing that:
“Today, Jack Layton flies to Washington D.C. to help President Obama in his fight for universal health care. And to fight to protect our cherished Medicare back here in Canada.”
Stop the presses.
In his remarks at the Woodrow Wilson Center in Washington, DC, Mr. Layton declared, “There is no doubt that strengthening of our system in Canada will be easier with public health care in the United States. Just as Canada built a strong public health system through a united effort, and just as America must do the same, so too can we strengthen and reinforce the health of all of our citizen through partnership.”
It sounds as if politics back home is driving this effort on Layton’s part and not an interest in advancing health care for Americans. Last time we looked (and we look regularly) there is no serious effort (alas!) to reform the Canadian healthcare system.
Shona Holmes, the Canadian patient currently appearing in a national ad on health care in the U.S., shot back: “The only partnership we have is a place for desperate Canadians to run.”
I spoke with Shona and asked her for her reaction to Mr. Layton’s visit and speech.
Shona remarked, “I am both shocked and appalled after reading the recent speech that Mr. Jack Layton gave in Washington. It is one thing to use a position of authority to win over votes in election time, but to use an opportunity to address another country about something so important as the future of their health care, and to fill that speech with untruths and misguided statements, is an embarrassment to me as a Canadian.”
Shona didn’t stop there. She has some hard-hitting questions for Mr. Layton:
“Mr. Layton, how you can possibly say there are no wait times, when our government runs a website which is only a recent development, to help our citizens work through the maze of getting treatment? Why are our babies being sent over the border to be born? Why in one month alone, did we need to send 36 patients over the border for government approved brain surgery? Why is the government paying for, in full, the procedure of Gastric Bypass surgery and sending those patients to the U.S. daily for this surgery because we don't have enough doctors here in Canada to help them? In your own words, you say, that the majority of Canadians are "satisfied" with our health care, were those 5 million Canadians that you talk about without a Family Doctor polled? And my last question, if you really are interested in making a difference, why are you not ashamed about my situation, and doing something here at home to make this right?”
Something tells me Mr. Layton won’t make answering these questions a priority. He’s busy at the moment working to encourage our politicians to foist a government-controlled healthcare system on all Americans.
It’s worth mentioning that Mr. Layton availed himself of a private clinic in the 90’s when he needed hernia surgery. No wait list for him.
Sorry if this is TMI -- I have a hernia.
I went to the doctor today and he says to me, "What do you do?"
I answer, "Healthcare policy."
He responds, "So you don't need to do any heavy lifting."
I wince.
And here's the punchline -- my hernia will be operated on by Dr. Lo.
I went to the doctor today and he says to me, "What do you do?"
I answer, "Healthcare policy."
He responds, "So you don't need to do any heavy lifting."
I wince.
And here's the punchline -- my hernia will be operated on by Dr. Lo.
Pfizer tries new uses for failed drugs
When scientists at Pfizer's Sandwich research facility in
However, when early clinical trials were conducted, the results suggested the drug wasn't sufficiently effective for its intended use. But it did work amazingly well for something else. It caused penile erections. So Pfizer decided to market the compound as Viagra and, in 1998, the drug made history as the first oral treatment approved to treat erectile dysfunction in the
The tremendous success of this pharmaceutical recycling effort is far from lost on Pfizer, the world's largest drug maker. About two years ago, it formed a research group to find alternative uses for compounds that don't work as intended. The 50 scientists in the group also try to find other opportunities for drugs in their early development stage.
The Indications Discovery Unit has a new home in the recently opened $200 million research building on the Pfizer Global Research and Development campus in
Donald Frail, chief scientific officer of the Indications Discovery Unit and director of Pfizer's
Most drugs must go through three phases of human testing. The first round is to make sure the compounds are safe. The second and third test whether the drugs are effective for their intended use. Frail said more than 75 percent of drugs in development never make it past Phase II of testing.
"It's a daunting job," Frail said about being a drug researcher. "It's a minority of scientists that see their drugs get to market."
Frail said Pfizer now focuses on six principal areas: oncology, inflammation, neuroscience, diabetes, cardiovascular and pain. Scientists in the Indications Discovery Unit look for other applications both within and outside those areas.
"The hunt is pretty fascinating," he said. "We let the compounds lead us to the patient. Our playing field is preset by the molecules."
An example of a drug being examined for other uses is Pfizer's Sutent, which is on the market for use against kidney and stomach cancer.
Pfizer has been testing it for other uses as well, and in March the company said Sutent showed "significant benefit" in patients with a form of pancreatic tumor.
But the research on the drug doesn't stop there.
"We're looking at it now for a different, totally nononcology application," Frail said.
Although most drugs never get regulatory approval, the possibility of finding a successful treatment or cure continues to drive researchers in their quest, Frail said.
"It's easy to be motivated when there are patients in need out there," he said.
Lots of talk about the FDA's transparency initiative. That's good.
Lots of gossip about the FDA supporting a codicil in pending tobacco legislation that would legalize drug importation. That's bad.
And remember, there's no such thing as drug "reimportation." That's putting lipstick on a pig. This isn't about making available to Americans the "same" drugs being sold to our neighbors to the north. This is about drugs from a multitude of nations (most notably those of the European Union). That means a drug that is said to come "from Great Britain" could just as easily originate from places such as Greece, Portugal, Latvia, or Malta. And basic economics dictates that goods from lower cost markets flow into higher cost ones. (In fact, more than 20% of all prescription medicines sold in the UK are "parallel imported" from lower cost nations within the EU.) These drugs, arbitraged through Canadian internet pharmacies and then resold to Americans may be dubbed "reimported" but that's just plain misleading -- because these off-the-back-of-the-truck medicines are not even legal for sale in Canada. So much for "the same drugs" as you can buy at a pharmacy in Toronto.
How can an FDA that wants to more robustly promote drug safety (and appropriately so) also support the importation of foreign drugs into the United States? It's bad enough when some of our elected officials choose to put rhetoric and politics in front of the public health -- it's something else entirely when such an attitude is adopted by the agency responsible for pharmacovigilance.
The career staff at FDA has consistently been against drug importation, so wither the switcheroo? Politics has no place in FDA decision making. And the last time I looked, the same career staff are in place. Draw your own conclusions.
In the spirit of transparency: what is the FDA's position on drug importation?
Lots of gossip about the FDA supporting a codicil in pending tobacco legislation that would legalize drug importation. That's bad.
And remember, there's no such thing as drug "reimportation." That's putting lipstick on a pig. This isn't about making available to Americans the "same" drugs being sold to our neighbors to the north. This is about drugs from a multitude of nations (most notably those of the European Union). That means a drug that is said to come "from Great Britain" could just as easily originate from places such as Greece, Portugal, Latvia, or Malta. And basic economics dictates that goods from lower cost markets flow into higher cost ones. (In fact, more than 20% of all prescription medicines sold in the UK are "parallel imported" from lower cost nations within the EU.) These drugs, arbitraged through Canadian internet pharmacies and then resold to Americans may be dubbed "reimported" but that's just plain misleading -- because these off-the-back-of-the-truck medicines are not even legal for sale in Canada. So much for "the same drugs" as you can buy at a pharmacy in Toronto.
How can an FDA that wants to more robustly promote drug safety (and appropriately so) also support the importation of foreign drugs into the United States? It's bad enough when some of our elected officials choose to put rhetoric and politics in front of the public health -- it's something else entirely when such an attitude is adopted by the agency responsible for pharmacovigilance.
The career staff at FDA has consistently been against drug importation, so wither the switcheroo? Politics has no place in FDA decision making. And the last time I looked, the same career staff are in place. Draw your own conclusions.
In the spirit of transparency: what is the FDA's position on drug importation?
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