Latest Drugwonks' Blog
Against the backdrop of a war which is an obvious test of the Westâs will to stand up to terror, writing about medical innovation or health care seems insignificant. But if it wasnât clear what the shaping impulse of CMPI and drugwonks is , maybe this is a good time to state or restate it now.
Medical progress has many enemies because many people regard the drug companies and biotech firms â because they are American, multinational, profitable and founded on patent protection â as evil. So therefore, many fail to separate out the benefits of progress from those that produce it. No different from the anarchists and communists that destroyed and appropriated the means of production and took the step of killing or diagnosing those who engaged in genetic research as insane because it conflicted with the Partyâs view that all equal in all respect. So therefore today governments push the notion of one size fits all medicine and cost-effectiveness for the group at time when effectiveness is a function of genetic differences that determine response to environment, lifestyle, medicines and disease.
There are those that twist science for their own political agenda. Some counterfeit medicines for profit. Some aid and abet counterfeiters â who are usually gangsters and terrorists working together — by giving them a clear path to sell fake medicines to Americans by barring law enforcement from inspecting packages that in the past have been shown to be laden with adulterated pills. Thatâs our Congress folks! And the scientific stupidity extends to the stem cell debate, to those who shade and overstate studies on one side or the other not to advance discussion but to slam the other side. Moreover, it extends to the media that canât take five minutes to do a Google search to determine if the expert they have on speed dial has any scientific substance behind them.
We have the tools and know-how to more effectively protect people against infectious diseases, bioterrorist threats. We have the capacity to eliminate inappropriate medical care. We have the ability to increase the value of health care by investing in information systems, medicines and decisionmaking tools that promote the prevention and prediction of disease. What we lack is the leadership and coalition of the wiling to accelerate a shift to the use of these advanced technologies and approaches.
Often the obstacle is the pessimism engendered by the tired old debate or critique advanced by the enemies of medical progress â and the enemies of America and capitalism â that profit motives are whatâs wrong with health care. This critique is simply a political tactic designed by those who want to exert their own control over the course and shape of medicine. They want to control the means of production. They want less profitable companies, different research agendas, different products, and different people in control over institutions critical to progress and ultimately want the government to make major decisions in health care.
The first strike of the anti-globalists and al Qaeda alike is the suppression of the creative energies of men and women wherever they seek to organize their energies to advance and enrich themselves, their families, and communities outside of authoritarian control. Without protection of intellectual rights and free markets therefore, the human condition diminishes.
A world that does not dare to defeat tyranny and evil when the opportunity arises â or gives up, in the elusive quest for redistribution, the individual freedom to compete with and control what one creates will cease to exist.
Terrorists everywhere win by sowing fear. They achieve victory by getting people to give up and by believing there is no hope. The same goes for enemies of medical progress who seek to scare us into believing that only a purge of private sector research, government run health care and limits on patent protection with a goal of redistribution will save us from financial ruin and exploitation.
The enemies of medical progress ultimately have no vision of a better, healthier world. We at drugwonks hope to offer one by providing courageous examples and aggressively challenging lazy, unthinking and manipulative efforts to undermine the efforts of individuals to advance and commercialize medical insights. We are at the beginning of a new revolution in human health and productivity and we aim to support those involved in making it happen.
Major findings published this week in the Proceedings of the National Academy of Science. : A so-called “me-too” beta-blocker works best for people with a particular genetic mutation. The drug, called bucindolol doesn’t have much benefit to most people with high blood pressure. But for people whose blood pressure is channeled through a specific pathway affected by the Arg 389 gene and have a specific mutation also have a 40 percent higher reduction in mortality from heart failure. People who carry an entirely different gene would do worse on the drug.
The research — carried out and sustained over a decade by Mike Bristow of the University of Colorado and Steve Liggett, now of the University of Maryland — has been translated into both a drug and diagnostic. Media reports (The Washington Post) have stated that “it is unknown, for example, whether even those patients with the responsive gene would do better on bucindolol than on the two beta blockers already on the market for heart failure — a serious disease that kills half its victims within five years.” In fact, to the extent that the expression of the gene and disease is pathway specific — and the Bristow-Liggett research suggests that it is — no other drug would work better. Thus, CV treatments would follow the path taken by targeted cancer drugs.
So much for the effort to shove everyone into the cheapest drug based upon average response. Sometimes an older drug will have spectacular benefits for specific patients as a result of combining it with a diagnostic and sometimes the new medicine designed with a diagnostic in tandem will work better for another group. Evidence based medicine is being replaced by genomic-based medicine. The problem is policymakers and pundits still act and think as if the technology and informatics of healthcare is mired in the 20th century. It’s changing. And if ways of paying for and organizing and choosing healthcare don’t change in response, they become obstacles to better health.
You can read the publication online at the PNAS website: “A polymorphism within a conserved B1-adrenergic receptor motif alters cardiac function and a B-blocker response in human heart failure.
Now that the AARP has said that the Part D benefit offers better discounts than unsafe and unregulated drugs from foreign websites, you’d think that the sideshow known as “drug importation” would find its rightful place deep within the dustbin of history. But, sadly, no. Alas some of our elected officials (in this case led by Senator David Vitter, R, LA) are still beating that particular drum.
“I don’t think … taking away small amounts of prescription drugs from seniors crossing back from Canada, et cetera, is the right thing do,” said Sen. David Vitter, a Louisiana Republican who sponsored the amendment to a Department of Homeland Security funding bill.
Senator Vitter doesn’t want a discussion he wants a soapbox, because he knows the facts — that uninspected, unregulated foreign drugs are unsafe and illegal — make his oratory vacuous. If he doesn’t know then he’s deaf, dumb, and blind.
This is a recording.
Unfortunately his is a chorus backed by a supportive media echo chamber. But the music is out of tune and increasingly out of touch.
Here’s what Senator Vitter is complaining about — recently the FDA launched an investigation confiscating thousands of drug shipments headed for the U.S. When opened, nearly half claimed to be of Canadian origin but, according to FDA investigators, 85 percent of them were from 27 other countries such as China, Iran, and Ecuador. And 30 of the drugs were counterfeit.
Facts are stubborn things.
If you are looking for media attention, please leave your name at the sound of the beep.
Here was the Headline:
Drug Interactions
Financial Ties to Industry
Cloud Major Depression Study
At Issue: Whether It’s Safe
For Pregnant Women
To Stay on Medication
JAMA Asks Authors to Explain
The article, by David Armstrong of the WSJ, dramatically begins:
“For pregnant women considering whether to continue taking antidepressant drugs, a study in a February issue of the Journal of the American Medical Association, or JAMA, contained a sobering warning: Stopping the medication greatly increases the risk of relapsing into depression……But the study, and resulting television and newspaper reports of the research, failed to note that most of the 13 authors are paid as consultants or lecturers by the makers of antidepressants.”
But the article, and the endless tongue wagging that followed, failed to note that most of drugs mentioned in the study are now available in generic form.
Oh.
That’s right folks. Big pharma and their hacks had nothing better to do than conduct research to advance the well-being of pregnant women suffering from depression knowing that the drugs in question were either off-patent or about to be. How is THAT possible?
The WSJ and Mr. Armstrong ignored the extensive literature looking at the genuine risks of treating depression to the fetus as well as the risks of not doing so. Not only are such women more likely to commit suicide or do harm to others, untreated depression during pregnancy itself is associated with impaired feto-placental function, premature delivery, miscarriage, low fetal growth and perinatal unwanted effects. Armstrong never looked at any other studies or cared to, just as he never looked at expiration dates on patents.
This article is nothing short of disgusting. It’s basis thesis is not even warranted by the facts but Armstrong goes along and eggs people into making comments that prejudge the research and researchers. Armstrong claims the study is clouded by financial ties to industry. But his article is devoid of even a nanobyte of objectivity. Whose judgement is clouded?
I am receiving lots of interesting emails from patients and groups who take exception to the piece in USA Today about the price of cancer drugs: The article, written by Elizabeth Szabo, parrots the approach formulated by Geete Anand at the WSJ both in terms of bias and sloppiness. It is of the “these drugs are hugely expensive and don’t add much to survival and these drugs are too pricey and people who are dying can’t afford them.” I have yet to figure out how drugs can be both ineffective and essential at the same time, but from Szabo’s rushed perspective being both just adds to the drama and criminality of having to spend, on average $1600 a year on cancer therapy.
The US spends about $24 billion on cancer drugs, less than is spent on cholesterol drugs and slightly more than ulcer medication. Total spending on cancer in the US is $75 billion. That means 32 percent of total spending on cancer is drugs, about average for chronic illness. Meanwhile the total cost of cancer to the US, including lost productivity due to death and illness is approximately $210 billion. By 2010, cancer drug spending will rise to about $55 billion. If we can limit use to those who can benefit the most and increase survival we save billions in productivity costs and quaity of life. Where was Szabo on all this?
1. The claim that most new drugs don’t “cure” cancer but just add a few months of life is meritless. To be sure the recent Tarceva and Gemzar trials showed no survival advantage, but they were genetically non-selective studies. There is no average cancer so there is no average response or survival rate. Many new targeted therapies increase survival signfiicantly for subpopulations precisely because they hit a specific pathway unique to a particular group. The substantial increase in life expectancy is masked by large clinical trials that include non-responders. For many, being disease free for five years with no tumor progression amounts to a cure. And that doesn’t include the cervical cancer vaccine.
2. Doesn’t quality of life matter? If you can life for two years without the horrible effects of cancer or chemotherapy and thereby stay at work, be in school, remain a parent, isn’t that worth something. Revilimid eliminates the terrible trauma associated with extensive and repeated blood transfusions which cost $60000 a year. What about the value of being able to treat the disease without such complications and disabling approaches.
3. Where is the responsibility of insurance companies to cover the cost of cancer medications. Why would it cover the cost of cheaper and less effective drugs but not Avastin or Herceptin? Indeed, tiered copays have been shown to discourage appropriate and cost-effectiveness use of medicines for diabetes and heart disease. Cancer is no exception. Companies should not have to shelling out money for medicines that insurance companies should be paying for.
4. Reducing cancer mortality by even 10 percent would generate over a trillion in productivity in America. Insurance companies might not gain, but we would.
Here’s the real question: Why doesn’t the media analyze the issue of new medical technology from this broader perspective and be more thorough in its investigation of clinical evidence prior to making such assertions as “higher prices but little added benefit.” And why does it focus on the price of medicines rather than the way in which price is used to ration access by health plans when the drugs themselves add significant value to the lives and wellbeing of Americans.
Es ist nichts schrecklicher als eine thatige Unwissenheit…That’s Goethe for “There is nothing scarier than an active ignorance.” Case in point, the most recent post on The Health Care Blog by someone named Maggie Mahar who managed to write over 800 words arguing that there too many cancer drugs in development. How does she come to this conclusion? By ignoring medical science and simply applying the old attacks on big Pharma to cancer research:namely that every single one of those drugs is simply a me-too medicine that offers no real survival benefit (note no mention of quality of life) Here’s what Maggie concludes about cancer drugs:
“As each drug company races to fill its own pipeline, a fragmented industry spawns a dizzying array of half-way cures. Too many drugs shrink tumors-but don’t bring any mortality benefit. Meanwhile, too much competition and too little collaboration makes it difficult for oncologists to sort out which drugs are most effective alone, which should be used together-and in what sequence. “
So in otherwords the explosion of targeted cancer drugs — which may or may not be used in combination — is causing too much choice and opportunity. And if the drug does not provide an everage survival benefit based on randomized clinical trials — regardless of whether subpopulations are helped or whether quality of life is enhanced — get rid of them. So the right response is to just cut down the number of drugs in development?
Let’s be clear, the rate limiting factor here is not that too many drugs for cancer, Alzheimer’s, Parkinson’s or infectious disease in development (is 100 too many? 50? What about phase III failures?) but the need to better understand underlying disease mechanisms and pathophysiology and link it to dose and drug response. Do you get the sense that Maggie understands any of this? She has written a book that makes the earth shattering discovery that medicine is fraught with….uncertainty!!!! Well ,targeted therapies are a direct result of how science provides the tools to do so, particular by eliminating the one size fits all approach to evidence based medicine that Maggie swoons over. A dizzying array of drugs? Only to those who fail to use new tools of analysis and are too lazy to advance the state of care. Or to journalists who think that average response to drugs is good enough or the only measure of well-being.
I am so sick and tired of health policy wannabes recycling the same old accusations about drug development and health care without even paying attention at the impact technological transformation plays in shaping the future. You can see that there have come to a conclusion shaped by ideological biases and then work backward.. Maggie Mahar is just one more uninformed health care conspiracy theorist who trashes medical progress without knowing of what it consists….
Wither pharmaceutical blogging? Have a look at the attached article on the “New Frontier” of pharmaceutical communications and one of its feisty evangelists … me.
Here’s the link:
http://www.bizjournals.com/sanfrancisco/stories/2006/07/10/newscolumn5.html
Article today in the Wall Street Journal on the persistent and quiet revolution going on inside the FDA to implement the Critical Path even as the brickbats from Grassley, Waxman, Hinchey and other media hounds come up with 19th approaches for evaluating 21st century medicines.
WSJ(7/10) FDA May Be Open To `Shifting’ Drug Trials
Jul 10, 2006 (From THE WALL STREET JOURNAL)
By Anna Wilde Mathews
CLINICAL TRIALS of medicines are traditionally performed in a “blinded” fashion so that the findings will remain secret until the studies are completed. But regulators and the pharmaceutical industry are increasingly interested in starting to use a very different model that lets studies change as they go along, based on early results.
Drug companies have begun to perform such adaptive trials for their new medicines, hoping for more efficient tests that could save millions of dollars. The Food and Drug Administration, meanwhile, is sending increasingly encouraging signs that it is open to considering the results of such trials. In a move that could lay the groundwork for greater future use of such studies, Scott Gottlieb, an FDA deputy commissioner, is set to announce today plans to develop regulatory guidelines for adaptive trials. The FDA has also put together an internal team to work with its drug-review divisions on the adaptive designs, which are statistically complex.
It’s clear what adaptive trial designs can help accomplish: As Peter notes, “Adaptive trial designs represent a major advance in drug safety because the best kind of safety is better understanding of how a drug works *
and who it works best for.”
How? Adaptive trial designs allows researchers to tailor the
study of the drug and its dosing to what they learn about the medicine and
the patient in real time. It’s another tool for personalizing medicine
that the 21st Century Task Force endorsed in is report.
As we pointed out in our recent Washington Times op-ed, the best post market safety is good pre-market surveillance through the use of critical path tools. The battle over FDA reform — and the real end game — how to use user fees — will come down to whether to invest in 21st century or 19th century tools. Spending dough on the status quo won’t cut it.
And speaking of NICE, have a look at Heinz Redwood’s new paper, “The Use of Cost-Effectiveness Analysis of Medicines in the British National Health Service: Lessons for the United States.”
Here’s the link:
http://www.phrma.org/files/Nice%20Report.pdf
The lessons learned are important ones and once again the phrase that pays (or, rather, doesn’t) is price controls = choice controls.
What do Madame Curie, Albert Einstein, Jonas Salk, George Hitchings, Joshua Ledeberg, Gertrude Elion and Sir James Black all have in common? They are Nobel Prize winners who have transformed the 20th century for the better through the contributions to science and medicine. And, according to the Wall Street Journal’s Thomas Burton, their research has, uh, “limitations” because they all did consulting or received honoraria from pharmaceutical firms. I guess by extension Louis Pastuer’s findings on pathogenesis are limited or have in Burton’s tart terms, “shading and nuances” because he received funding for the work from French beer and wine producers.
Burton wasn’t talking about Nobel prize winners in his article, of July 6, 2006 in the The Wall Street Journal Europe , “Antismoking drug from Pfizer shows promise in research “
He was writing about Chantix, a new Pfizer drug that helps suppress smoking by smoothing out the production of dopamine (not blocking as Burton states) involved in creating the craving for nicotine. There is less binging or withdrawal as a result. I know a little bit about the drug since I had the chance to talk to the Pfizer pharmacologists who designed the drug to produce the biochemical effect. In any event, the drug uses a different pathway and novel approach so the robust results are not surprising one respect.
What is suprising is that Burton decides to regard the fact that the researchers source of money is somehow a limitation on the drug’s effectiveness equal to that of the study’s exclusion critieria….
“Despite the positive findings, there were several limitations to the research. One is the fact that people with pre-existing conditions such as depression, alcohol or drug abuse, and diabetes requiring insulin were excluded from some of the studies. Another stems from the fact that the majority of authors of the three studies, which were published in the Journal of the American Medical Association, either have done consulting work or received honoraria or research grants from Pfizer and other drug companies, or are Pfizer employees or shareholders.
Such apparent conflicts of interest won’t normally change the major findings of research. But they can affect nuances and shadings of the way they are presented. “All of these papers were rigorously peer-reviewed,” says the University of Wisconsin’s Douglas E. Jorenby, who headed one of the studies. (He has received research funding from Pfizer but not consulting fees or honoraria.) A Pfizer spokeswoman says, “Regarding consultation fees, Pfizer follows standard protocols for consulting agreements and provides adequate disclosure.”
As one of my friends who works for a drug company noted, “Based on the logic presented here every commercially conducted/funded research project has a built-in âlimitationâ. Seems easier just to add some standard warning label - like on cigarettes - to every commercially supported study and be done with it.”
But it’s worse. This approach slimes the good work of every good and great researcher who in any way associates with private companies. It disqualifies and discredits pivotal work and deprives the public of pathbreaking research that cannot be duplicated anywhere else. Let’s be clear: not only is the commercialization of science not bad. Commercialization of science, it’s industrialization is critical to advancing the public health. Those purists who want science to be conflict or profit free want the medicine THEY can control, plain and simple.
That’s a sure-fire recipe for medical Lysenkoism.
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.
