Imagine a society that lets its automakers oversee crash tests on new models, allowing the industry to report results, as it sees fit, to government and consumers. Sometimes, an automaker might not reveal the outcome of a test that turned out badly, deciding that the dummies in the vehicle had been too short—no wonder their chests were crushed!
In other cases, a company might postpone reporting on crash test results for a year or two, hoping that later trials would turn out better. In these cases dozens of trials might be required in order to achieve the desired outcome. The car maker would, of course, pass the additional costs along, in the form of higher sticker prices.
In this society, crash tests are not run and paid for by an independent entity like our National Highway Traffic Safety Administration (funded by taxpayers) or the Insurance Institute for Highway Safety (funded by insurers). Instead, the auto industry itself finances and controls the trials. Automakers also provide most of the funding for the government agency that rules on car safety. Finally, under this system, head-to-head comparisons of cars in a similar weight class are frowned upon. Such trials would create winners and losers—and who wants to be a loser? Instead, each company tests its own cars, and when outcomes finally are published, they tend to be excellent.
Probably you already have guessed where I’m heading. The system I’ve sketched comes pretty close to describing how we try to assure the safety of the prescription drugs and medical devices sold in the U.S. We may be the only country in the developed world that allows the companies that manufacture and peddle medical drugs and devices to control what we know about them. The industry also provides much of the funding for the Food & Drug Administration, the agency responsible for weighing the risks and benefits of these products. No wonder the FDA doesn’t require manufacturers to test their products against similar, less expensive products already on the market. Instead, the FDA asks only that the sponsor to test its new entry against a placebo—demonstrating that it is “better than nothing.”
In the U.S., medical research is rife with conflicts of interest. As Merrill Goozner recently testified before the Institute of Medicine (IOM) panel on “Conflict of Interest in Medical Research, Education, and Practice,” the share of our clinical research funded by industry has doubled over the past 30 years, and now accounts for well over 60 percent of all clinical trials. As a result, Goozner testified, the medical literature is riddled with:
- reports of negative research results being suppressed
- delays in publication
- failure to report serious adverse events in clinical trials
- the slanting of systematic reviews of medical evidence
- and a systematic bias in research results that favors the outcomes desired by study sponsors.
In written testimony for the
IOM, Goozner, who is director of the “Integrity in Science Project” at
the Center for Science in the Public Interest, questions the
objectivity of those who review research trials and draw up guidelines
for physicians nationwide: “A survey of authors of clinical practice
guidelines written in the 1990s found 87 percent had some form of
interaction with the drug industry, and 59 percent of authors had
relationships with companies whose drugs were considered in the
guideline. Meanwhile, industry underwrites both the annual meetings and
the clinical practice guidelines sponsored by many professional
societies.”
Both medical journals and the mainstream press have spotlighted cases
where practice guidelines created by industry have turned out to be
dangerous for patients (see, for example, these 2007 articles from The Clinical Journal of the American Society of Nephrology and Lancet and this 2004 story from The Washington Post).
Meanwhile, for-profit manufacturers control what the average
practitioner knows about new developments in medical technology: in the
U.S., half of a physician’s continuing medical education is financed by
suppliers.
Even worse, Goozner told the IOM, “about a quarter of outside advisers
sitting on the Food and Drug Administration’s advisory committees
require waivers of the nation’s conflict-of-interest laws because of
ties to industry, and after the National Institutes of Health relaxed
rules restricting in-house researchers’ ties to industry, hundreds of
top-ranking scientists and research administrators forged consulting
and other financial arrangements with the private sector.”
Apologists for this conflicted system will argue that it is all but
impossible to find experts who have not taken money from the companies
sponsoring products that they are supposed to judge. But this simply
isn’t true. Granted, some of the biggest names in various specialties
have become well-known in part by becoming highly-paid consultants to
industry, but this does not mean that they are more knowledgeable than
other physicians.
And today, more and more doctors are fighting industry’s influence over medical practice. “No Free Lunch,”
for example, is an association of health care providers that
“discourages the acceptance of all gifts from industry by health care
providers, trainees, and students.” The Prescription Project,
a group led by Community Catalyst in partnership with the Institute on
Medicine as a Profession, seeks to eliminate conflicts of interest by
promoting policy change at academic medical centers and professional
medical societies. Among its solutions: “Exclude doctors with financial
ties to drug companies from sitting on hospital and medical group
formulary committees and committees overseeing the purchases of medical
equipment,” and “end the practice of drug and medical device
manufacturers providing financial support to any accredited program
that provides continuing medical education. “Instead, they argue that
manufacturers should “pay into a central fund that will disburse funds
to [such] programs.”
The usual “rationale” for allowing industry to share a bed with those
who review research and set guidelines, Goozner notes, is that it will
foster innovation. Yet he points out, innovation in medicine, as
measured by the number of new drugs and biologics using new active
ingredients, “has fallen fairly steadily over the past decade, a time
marked by a growing financial interaction between these two ostensibly
independent spheres.”
In fact, Goozner suggests, excessive financial entanglements between
physician-researchers and the private sector “may actually be harming
innovation by channeling scarce scientific resources into medically
insignificant research endeavors.” Rather than gambling their research
dollars on trying to develop an original product, the manufacturers who
finance and control trials are more likely to fund development and
trials of a “me too” drug similar to a successful drug already on the
market. Thus, we have dozens of medications for allergies, and
precious few to treat acute macular degeneration, a disease that is
likely to leave many baby-boomers blind.
Moreover, Goozner argues, when it comes to controlling research,
for-profit companies often “inhibit scientific collaboration, fostering
a culture of secrecy,” claiming that any discoveries are “proprietary”
and should not be revealed to their competitors.
In my book Money-Driven Medicine, Genie Kleinerman, chief of pediatrics
at Houston’s M.D. Anderson Cancer Center, recalls a time when she was
doing work on two drugs made by different companies: “Together, the two
drugs they seemed to do a better job of targeting malignant cells of
osteosarcoma, a bone cancer that occurs in children. In the lab, we had
shown that you could combine the two agents. Scientifically, it was
fine, but now we needed the companies to do clinical trials. My lab
work was being provided free, but in order to get approval from the
FDA, the companies had to invest in trials and collect the data.
“But we couldn’t get them to co-operate,” she recalls, reliving the
frustration. “The lawyers for the two companies couldn’t come up with
an agreement on who would own the rights to the combination and who
would pay for what.”
What can be done? We live, after all, a capitalist society which
believes that ultimately, free-market competition will produce the most
creative solutions. Yet if our goal is to create medical technology
that saves lives, often what is needed is collaboration, not
competition.
And when it comes to evaluating the newest medical technology we need
to have those decisions made by disinterested, well informed physicians
and researchers, based on the best medical evidence available. Here, I
agree with Goozner: Decision makers responsible for interpreting the
results of clinical trials in order to make coverage decisions and
write “best practice” guidelines must be “entirely free from conflict
of interest." Here, we should “draw a line in the sand.”
Cynics argue that that this can never happen. Given the power that the
health care industry’s lobbyists enjoy in Congress, any government
agency that attempts to oversee quality will find itself operating at
the pleasure of special interests. Look at what happened, they say, in
1995, when the Agency for Healthcare Research and Quality (AHRQ)
released a set of “best practice” guidelines that discouraged the use
of surgery in treating lower back pain.
“A number of politically active surgeons took offense,” recalls Dr.
George Lundberg, who was then the editor of The Journal of the American
Medical Association, “and aggressively lobbied members of Congress,
demanding that the agency back off…” At the time there was talk of
eliminating AHRQ entirely, but Congress finally settled the matter by
slashing its budget.” Knee-capped, the agency still hasn’t recovered.
What we need, virtually everyone agrees, is a government agency
responsible for health care quality that is somehow insulated from
political pressure. But can it be done?
Yes. In fact the U.K. has already done it. In Part 2 of “Obstacles to
Reform,” I’ll describe how the National Institute for Health and
Clinical Excellence (NICE) maintains an arms-length relationship with
both government and industry, while creating “best practice guidelines”
for health care providers, and deciding what products and procedures
the U.K.’s National Health Services will cover. Operating in a
capitalist society not that different from ours—where for-profit
corporations do their level best to protect their shareholders’
interests—NICE nonetheless manages to make independent decisions.
ASCO is a trade group masquerading as a scientific body. It was highlighted in a video by the Healthcare Channel, questioning a drug’s use in breast cancer. $1 million annually in lobbying? >40% of funding from industry? I’m surprised it isn’t more.
http://blogs.wsj.com/health/2007/12/11/avastin-for-breast-cancer-the-pre-history/
A friend of mine had exhibited at least fourteen times at an annual ASCO meeting. Acres and acres of unbelievably extravagant drug company exhibits – 50 ft x 50 ft. and even larger and extremely expensive. In addition, as you read the programs at this event, you see that all of the other official ASCO activities – luncheons, balls, dinners, special sessions, messaging services, DVD and audio CD production, multi-room simulcast – are all paid for by “an educational grant from (your drug company name here).”
In addition there are many other national and regional ASCO meetings, symposia, and other “educational” events – all of which are directly and openly funded by the pharmaceutical companies. Could anyone think Genentech and Roche (which owns most of Genentech) don’t have the juice necessary to get an abstract published or, as in this case, to create a special oral session for it? No surprises here.
An article published by the NIH concluded that about one fourth of abstracts at ASCO Annual Meetings have an author with a personal financial interest. Since many of these abstracts are about the results of clinical studies, this means that the study results are being penned by authors that may have a personal financial interest in the outcome.
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17704409&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed
Another article touches upon the attitudes toward research participation and investigator conflicts of interest among advanced cancer patients participating in early phase clinical trials.
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17687154&ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed
These two articles touch on a critical subject – when an oncologist recommends a treatment the reason behind the recommendation may be complex. It can be a result of the doctor’s training and experience in combination with the investments made by the hospital or the doctors own research interests or their financial relationships with various outside entities.
There are rampant conflict of interests. Which is why we need to get health care reform out of the hands of the political parties and into the hands of the American public. We have done two surveys in Iowa and Washington state and have the data to show there is very solid consensus across party lines on some key areas of health care reform.
We need to work together and identify those elements a majority of us can support and build a Voters’ Health Care Platform for 2010–to have a large enough base to effect reform.
Then we need to hold up that Platform as a template we can support and hold elected officials accountable to us.
We need to remember that anyone can give a candidate money–only you and I can give them their jobs.
See our study at: http://www.codebluenow.org
Kathleen O’Connor
Founder and CEO
CodeBlueNow!
Just to clarify–
when Greg refers to ASCO,
he’s referring to the American Society of Clinical Oncology–people who should be watching out for some of the most vulnerable of patients.
Take a look at the links Greg provides –
(I’ll be back with response to all comments–just wanted to clarify who ASCO is.)
mm
I think that the UK’s NICE is a poor choice for the appropriate setting of “arm’s length” standards for the practise of medicine. They seem to promote the use of statin-type drugs much more than is warrented by the evidence, for whatever reason.
Morley
Morley, Kathleen, Gregory–
Thanks for your comments:
Morley–You’re right, NICE’s 2006 recommendation did seem to go overboard in recommending statin use. (Though I don’t know that there recommendation was any worse than what had become standard practice here.)
But as of Feb 8 of this year, NICE has come out with a new recommendation which would would significantly reduce statin use. “http://www.pulsetoday.co.uk/story.asp?storycode=4117369
British Hypertension and Heart UK were very unhappy. (I’m just guessing, but it’s likely that British Hypertensoin and Heart UK receive funding from drug-makers.)
What’s important, I think is that NICE’s 2006 recommendation doesn’t seem to have been influenced by politics. Like most of the Western World, NICE simply became overly enthusiastic about Statins. But it is worth noting that NICE said that no prescription brand of Statin was better than any other–and recommended use of generics.
So the recommendation was not driven by trying to please or placate the drug companies.
As you’ll see in my next post on “overcoming obstacles to reform” Nice really is quite indepdendent and doing its best to base its guidelines on medical evidence. Of course there are many grey areas of medicine, and statins seems to be one of them. ..
Moreover, it’s refreshing to see that NICE is always open to reviewing the research, including new reserach, and revising their opinion.
Kathleen– you are right, any reform plan will need grass roots support. But so far, the American people are very divided on issues like whether healthcare is a right, whether they are willing to pay more in taxes to guarantee access for everyone, whether they think everyone should have access to the same quality of care. I’ll write about this in part 3 of “Obstacles to Reform”
The polls you cite in Washington and Iowa are extremely interesting–and reflect many of the divisions I’ve noted above.
Gregory:
Thanks for the many links illustrating how drug
companies control what we know about their products. It’s particularly disturbing when a group like ASCO which sounds like it should be a scientific group advocating evidence-based medicine is, instead, a trade group–i.e. an arm of industry.
I’m always hearing that the FDA treats drug and device companies as “clients” because they fund the agency through fees. I’ve even paid those fees myself.
But I also fund the State Highway patrol through taxes and speeding fines, but they do not treat me with kid gloves!
No, the issue is that politicians get campaign dollars from drug and device companies, and since they control the FDA’s budgets the companies have pressured them to be soft on the industry.
THAT is the reason for the kid gloves. Even if the FDA took the gloves off, the industry would keep coming back for new approvals. That’s their livelihood. They have to!
Follow the political money and you’ll find your answer.
Maggie-
I think you got a little carried away with your criticism of FDA. First of all, industry payments have nothing to do with why drugs are tested against placebo rather than other drugs. This is what the law says and it has been that way since long before industry payments. The law requires FDA to approve a drug if it is “safe and effective”, ie, better than nothing. FDA has, in fact, been able to keep less effective drugs off the market when they have similar or greater toxicity than more effective drugs but, as you point out, it is difficult to prove that one drug is less effective than another if they are not compared head to head. The problem with head to head comparisons is that “non-inferiority” studies, clinical trials designed to show that a new drug is just as effective or better than an old drug are very complex from a methodological standpoint, involving a lot of assumptions that may not be true. Worst of all, non-inferiority studies give an incentive to obscure differences between study drugs. For example, if you recruit a lot of subjects who can’t be helped by either drug (because they don’t really have the disease the drugs treat or they are too sick to improve with any treatment or very likely to improve without any treatment) then you have a very good chance of showing that the two drugs are equally “effective”. In principle it is much more straightforward to prove that something is superior to something else. This is fine when you’re comparing a drug that is much better than placebo but when you are comparing two drugs that both work, unless there is a huge difference in effectiveness, an enormously large study is required to prove that one is superior to another. Furthermore, you don’t want to limit new drug approvals to those drugs that can be proven superior to existing drugs: if they are about as good or not quite as good but have less (or different) toxicity then you want them on the market as competitors.
What is interesting is changing the language around reform. We totally avoided words like “right”, “single-payer” and “health savings accounts” or “marketplace” since these words are so loaded and cause division vs. find common ground and build consensus.
The real barrier to health care reform is partisan politics.
Kathleen O’Connor
CodeBlueNow!
Kathleen,
I would probably not describe the barrier to health care reform simply as “partisan politics.” It’s better described as corrupt politics. It’s the flow of campaign cash between the health and insurance industries and the politians. The public wants reform and the industry wants exactly the opposite. And it is they who are funding the elections.
Until we get public funding of campaigns, that’s just the way it will remain.
The FDA puts the onus on the drug company to conduct a clinical trial to show that a drug is different from a sugar pill. The way the FDA’s approval standards are, the drug does not necessarily have to have a very great effect in order to be approved.
What matters most to patients is not whether a company’s drug is better than a placebo, but whether it is better than established treatments. But the FDA cares only that the drug has some effect in order to be approved.
Is that be a benefit to the patient? What if there are other drugs that a patient could take instead that would actually be better? The FDA doesn’t really care about that.
You’ve got two drugs, one drug that is really effective and another drug that is barely effective. The drug company that manufactures the latter drug markets it like it’s a “breakthrough” medicine. It has all these glitzy ads and direct-to-consumer advertising and lots of patients and lots of doctors will use that medication.
Patients are actually in a sense being denied a more effective treatment because the FDA doesn’t require that drugs that come on to market be at least equivalent to, or better than, the drugs that are already out there (head to head comparisons). All they have to do is be better than a placebo.
The problem with these “me-too” drugs is that they are typically marketed as if they were important new breakthroughs, and typically with very high prices. Many new expensive “me-too” drugs are not necessarily better than older generic and less expensive drugs.
Because new and heavily marketed drugs seem like they must be better, drug companies can command higher prices. This is an important driver of drug costs. But the new drugs were never compared with older drugs.
Some changes that might help would be changes in the regulatory process in the FDA, the possibility of “head-to-head” comparisons and tighter regulation of advertising.
Marc, Gregory, Jack, Kathleen–
Good to hear from you.
Marc–
I hear what you are saying about how head-to-head comparisons can be complicated.
But not always. Here’s an easy example: After Vioxx came out, the Mayo Clinic, Kaiser and the VA compared its effectiveness to the effectivness of older, far less expensive painkillers. They used their database of patients’ reactions, and independently, each discovered that Vioxx was no more effective. And since they had much less information about the side effects of this new drug, they considered it riskier.
Vioxx’ only advantage was this: while the older painkillers caused gastrointestinal bleeding for a small group of patients, Vioxx didn’t. So Mayo, the VA and Kaiser prescribed Vioxx only for that small group of patients.
Three years later, Merck was forced to take Vioxx off the market because it was causing heart attacks and strokes. Some 40,000 people died.
Vioxx should never have been so widely prescribed. If the FDA had insisted on seeing an unbiased study showing whether Vioxx was more effective in controlling pain, it would have concluded that Vioxx should be approved only for the small group who can’t tolerate older painkillers.
You say that as originally written the FDA law didn’t require comparative effectiveness information.
You’re right. But if you look back at how the FDA law was originally written– well, it’s like finding out how the sausage is made.
Lobbyists had a lot to do with what is and isn’t in the law.
When the FDA was created in the 1930s, drug-makers were required only to show that their products were safe– not that they were effective or did what they claimed they did.
According to A Brief History of the FDA: (http://www.actupny.org/documents/FDAhandbook2.html)
“Many pharmaceuticals took advantage of a trusting public to sell largely ineffective and sometimes dangerous substances. The unregulated use of antibiotics in throat lozenges and syrups resulted in bacteria becoming resistant to useful drugs and provoked sometimes-fatal allergic reactions.
“Calls that proof of efficacy be legally required received an inhospitable reception in the pro-business climate of the Eisenhower administration. In 4 years of Senate hearings (1959-62), Tennessee Senator Estes Kefauver waged a lonely battle trying to expose drug industry stock manipulation, advertising fraud, collusion with the FDA and deception of the public.
In April 1961, Senator Kefauver submitted the original draft of his bill to strengthen the FDA. Over the next 15 months, under pressure from the drug industry lobby, a Senate committee effectively crippled the bill.
“It took the birth overseas of thousands of limbless babies and the efforts of a single official, Dr. Frances Kelsey, to turn the tide.”
Finally, in response to the Thailidomide scandal, in 1962, the Kefauver Amendement became law. “”The Drug Amendments of 1962,” was signed into law by President Kennedy. (MH/SS)
The Kefauver amendment is significant . . .for basically one reason: it requires that the FDA ensure drug manufacturers prove efficacy before a drug is put on the market. Efficacy must be shown for the specific use for which the manufacturer wants to market the drug. Before 1962, only proof of safety was required. In other words, manufacturers have got to prove a drug does what they say it does. ”
But they still don’t have to prove that a drug is more effective than less expensive drugs already on the market. The manufactuers wouldn’t stand for that–and are still fighting attempts to establish a “comparative effectiveness institute.”
Finally, you wrote: “if you recruit a lot of subjects who can’t be helped by either drug (because they don’t really have the disease the drugs treat or they are too sick to improve with any treatment or very likely to improve without any treatment) then you have a very good chance of showing that the two drugs are equally ‘effective'”
That’s true– and demonstrates why you don’t want the drugmakers deciding how to design the trials . .
Gregory– you wrote: “The problem with these “me-too” drugs is that they are typically marketed as if they were important new breakthroughs, and typically with very high prices. Many new expensive “me-too” drugs are not necessarily better than older generic and less expensive drugs.
Because new and heavily marketed drugs seem like they must be better, drug companies can command higher prices. This is an important driver of drug costs. But the new drugs were never compared with older drugs.”
Exactly–
Kathleen & Jack–
I have to agree with Jack.
Industry has too much control over what we know about drugs because industry funds (and controls) too many Congressmen. And I do think, as I wrote at the end of today’s post (part 2), health care reform may depend on campaign finance reform.
Kathleen, Let me add that I don’t think we can entirely avoid words like “right”, “single-payer” and “health savings accounts.”
Many people in this country believe that healthcare is not a “right”–polls show that responses break down by party.
And John McCain, the Republican’s candidate for president believes in Health Savings Accounts as a solution to our health care crisis. Yet those accounts are useful only for those people who have enough discretionary income that they can afford to save substantial amounts of money. Most people are not in a postion to save enough to cover their day-to-day health care expenses. (Half of all American households earn less than about $47,000 joint–and many of them are supporting children.)
So health savings accounts do nothing to improve access to care. And they do nothing to improve quality of care–even if consumers are spending their own money, they’re just not in a position to distinguish between a drug like Vioxx and a cheap pain-killer–or to know that they were being ripped off (and exposed to serious risks) if they took Vioxx.
So those who believe that health care is right–and that everyone should have access to high quality care, even if they don’t earn enough money to fund a health savings account–and those who believe that
health care is not necessarilty a right, that it’s up to everyone to take care of their own famlies, have a very different view of things.
Those differences are real, and I doubt that we will find “common ground” between those who think high quality health care is a basic human right and those who don’t.
Ultimately, there will be a battle, just as there was a battle over Roosevelet’s New Deal (which brought us Social Security) and just as their was a prolonged battle over whether the elderly had a “right” to tax-supported healthcare (which brought us Medicare.)
An article written in Medical News Today tells us that the American Society of Clinical Oncology (ASCO) is to issue guidelines on how physicians should discuss cost of treatment options with cancer patients.
I never heard that ASCO has been knighted a regulatory agency. Some experts warn that the new guidelines could raise costs even further, thus limiting access to cancer patients.
When there are still financial incentives for infusion therapy over oral therapy or non-chemotherapy, and financial incentives for choosing some drugs over others, some oncologists will continue to choose drugs which are profitable.
The profit incentive needs to be removed from the choice of cancer treatments. Patients should receive what is best for them, not what is best for their oncologists. ASCO has a history of going to the mat for its membership, while disguising its positions of self-interest as patient care issues.
The anemia drug controversy was a very good case in point. ASCO fought hard for their trade members over new Medicare limits on payments for anemia drugs. Medicare challenged groups like ASCO to come forward with evidence for their arguments. They didn’t.
Healthcare network providers had abused giving the drugs so much that they couldn’t convince Medicare (or the FDA) otherwise. ASCO was in a snit over it.
Perhaps many practices develop evidence-based guidelines for their own individual practices or modify guidelines based on evidence which they use as their defined evidence-based standards for their practices. The self-educated oncologist doesn’t “submit” to the status -quo. They can think for themselves.
What was forgotten was the real issue, that a number of physicians had been going overboard in prescribing pharmaceutical EPO. They can very easily be inappropriately influenced by pharmaceutical companies when prescribing drugs, and they sure can become mighty righteous when there’s a threat to their pockets.
The ultimate tragedy is that the course of oncology therapy has been driven not by compassion or true concern for the patient, but rather by the perpetuation of a research culture that cannot conquer a disease, or for that matter, ever embark on that process for fear of putting themselves out of work.
It’s only when ASCO has appointed itself as the judge/jury/prosecutor/defense rolled into one and not invite input from all relevant parties that their decisions have become suspect.
In short, a patient and their family must be their own best advocate and get to the heart of the matter as to why a specific treatment regimen is being suggested, not by ASCO guidelines.
http://www.medicalnewstoday.com/articles/101693.php
Gregory,
You cut to the heart of the matter when you wrote:
“The profit incentive needs to be removed from the choice of cancer treatments. Patients should receive what is best for them, not what is best for their oncologists. ASCO has a history of going to the mat for its membership, while disguising its positions of self-interest as patient care issues.”
Case in point with drugs approved for cancer.
The FDA approves Avastin for breast cancer, despite no increase in survival. There were problems with the clinical trial that let to the approval.
There were a number of issues with the clinical trial highlighted by the FDA including lack of data, the subjective nature of the findings, missing information, and protocol violations.
The idea that approving drugs based on population studies has its limits. What may or may not work for the average population may not apply to the individual.
Was this drug worthy of approval?
http://www.cancermonthly.com/iNP/view.asp?ID=209
Maggie – Thanks for the work you do on bringing to light all the subtleties in the morass that is our health care system. I thank Gregory and others for their illuminating comments here as well.
I understand your lack of enthusiasm over ASCO’s power given the clear ties between these doctors (and doctors as a whole) with pharmaceuticals. That said, I recently blogged in support of ASCO’s decision to incorporate treatment cost as a factor to be considered when they advise cancer patients.
http://whatifpost.com/costs-of-cancer-care.htm
Very few patient or their families have the information, expertise or confidence to “be their own best advocate and get to the heart of the matter as to why a specific treatment regimen is being suggested.” Particularly not when going through the devastating diagnosis of cancer.
The expanded marketing of drugs for purposes they were never determined to be effective for (the debate on how you define “effective” aside) extends beyond oncology. We have seen the same thing recently with Vytorin.
http://whatifpost.com/have-a-heart.htm
Clearly, the FDA in one way or another feels drug lobbyists’ reach. While we can be realistic about getting lobbyist money out of government when so much of politics is influenced by corporations, increasing government regulation of health care products and their ties to our physicians – as well as how safe and effective these products truly are, how they’re priced, and incentives for their efficient development – is our only hope for diminishing the stranglehold for-profit interests have on our health care.
Emily Cleath
Emily–
Thanks very much for your comment.
It led me to your website, which looks very interesting . .
Emily–
Thanks very much for your comment.
It led me to your website, which looks very interesting . .
NHS WITHHOLDS CANCER TREATMENT
Occasionally, the failures of socialized medicine are so egregious that they knock the scales from the eyes of the most ardent true believers. Thats what happened to Sarah Anderson, an English ophthalmologist:
I have spent my working life in th…
These two articles touch on a critical subject – when an oncologist recommends a treatment the reason behind the recommendation may be complex. It can be a result of the doctor’s training and experience in combination with the investments made by the hospital or the doctors own research interests or their financial relationships with various outside entities.