Latest Drugwonks' Blog
The first target was CT scans which we were told were a waste of money unless bureaucrats decided who got them first. Just like in the UK or Canada where people wait 18 weeks.
Second target was Avastin: The claim is that their is scanty evidence that the new drug does much more than extend lives by a few months and that the quality of life benefits are hard to measure.
The piece by Gina Kolata and Andrew Pollack could have been a lot worse but it could have been better it if had discussed the role personalized medicine will play in addressing the issues the article seems to suggest only a government agency run by economists will solve...
And what's up with their sources?
The series talks about scant evidence for cost effectiveness yet Kolata and Pollack point to NICE as an example of a government institute that decided, based on the "evidence" that Avastin not cost effective based on its cost per year of life extended. But NICE measures the value of an additional disease free year of life at $50000 which has lead them to approve birthing pools for pregnant moms and Accomplia for obese patients, a drug in clinical trials that helped people lose 9-15 lbs than with a placebo but not Avastin. Michael Rawlins the head of NICE bluntly says that the value of the additonal life year is just arbitrary. Talk about scant evidence! (By contrast Topel and Murphy, who did a systematic evaluation came up with a number of nearly $300k).
The article's experts on cost effectiveness, the consumer's providing evidence of what a complete waste of money Avastin is were Barbara Brenner of Breast Cancer Action who is notorious for campaigning against all new drugs and even early screening for breast tumors and Consumer Watchdog, which is headed up by Harvey Rosenfeld. Rosenfeld has made millions by the collection fees for bring administrative charges against insurance, HMO and drug companies in California. As a friend of the court, Consumer Watchdog also gets a cut of any successful lawsuit it participates in such as the one against Univ of Wisconsin's stem cell patents...
I don't where to begin about the claim that Avastin just prolongs life a couple of months. This is just a Grassley-fed lie.
Treating kidney cancer with Avastin prolongs progression free and overall survival by 10 and 17 months respectively compared to placebo.
In colorectal patients adding Avastin to existing treatments also added 23 months of life in peope who responded.
I could go on and will in a later post..
At the end of the day there is no evidence gap. There is a values gap. Either you believe it is worth paying for drugs to advance end stage cancer patients -- and that could be you or someone close to you -- for anywhere from a month to two years depending on how your cancer progresses or you don't. Either you believe after paying thousands of dollars of premiums and not spending much on health care you get to have a say or you don't. Either we continue to make progress, reduce death and increase survival against disease which happens incrementally, or you don't.
And the failure of Kolata and Pollack to acknowledge the promise of personalized medcine to move cancer care from hit or miss to hitting the target skewed the debate away from the science and where the discussion of health care technology assessment and Avastin in particular is already heading.
They should know better.
But it's summer and Madonna is brainwashing A-Rod with Kabbalah so they get a pass. For now.
"But Mr. Carpenter stood by his conclusions, releasing a 151-page memo and his raw data on the Internet. After a detailed comparison, both sides' records turned out to have been imperfect, he said. "I'll frankly admit that we omitted four or five of the black-box warnings," Mr. Carpenter said. But the FDA "missed a whole bunch of black-box warnings" as well, he said."
Yes, well you know what they say, sins of omission are seldom fun.
"An FDA spokesman said the agency hadn't seen Dr. Carpenter's response until it received a copy from The Wall Street Journal, and hadn't had time to review it."
Sound familiar? It's strangely reminiscent of Dr. Nissen's rationale for why he didn't go to the FDA with his now-infamous (and discredited) meta-analysis.
Birds of a feather. Just another sad example of Tabloid Medicine.
Is there a difference in the quality of communication when money is given to a non-profit provider of information, especially when that money is shifted from the objects of criticism to the critics? Or is this simply a matter of turning medical education into hush money?
Can academic medical centers, who have treated primary care issues and primary care physicians as abused stepchildren, really run top quality CME programs? Can medical societies, usually staffed by two people and a temp do the job?
CME is too important -- particularly for the minority community -- to be left to amateurs who think it is a dirty business, not an important component of the public health.
It's one thing to insure that CME is objective and made widely available and affordable to as many clinicians as possible using both online and in person formats. It's another thing to shut down an important avenue for disseminating information: for-profit organizations.
The last time I checked medical schools and AMCs were for grabbing tuition, grants, fees, endowments, spending millions on marketing, ads, endorsements, wooing high profile specialists and practices. And they make no bones making people like you and me, when we have no insurance, paying upfront and top dollar for the quality care the advertise on TV and on the visors they give away at baseball games.
Somehow when a drug company wants to spend millions to educate doctors, not on their drugs, but on disease management, that's a scummy thing to do.
I am sick and tired of the pontification on the one hand and the pharmaceutical cowardice on the other.
Caving in does not buy peace, it only prompts more attacks.
As Thomas Jefferson observed: "A coward is much more exposed to quarrels than a man of spirit. "
They got caught when Temple and FDA economists found significant, uh, omissions in their daabase and "rounding" errors that when accounted for essentially eliminated any difference in the number of black box warnings.
According to the WSJ Carpenter and Avorn did a fix. If you read the NEJM apology for getting caught by Temple the Carpenter and Avorn fix is this: they just add new black box warnings gleaned from the "addition of data through December 2007" Ta-da! They "found more modest but still significant association between just-before-deadline approvals and safety problems."
Here's the trick: The black-boxing of a drug is a response to policy pressure as much as writing an article about black boxes is. Adding data throughout 2007, when pressure was on the FDA to ADD black box warnings from Grassley and others, data that is not included in Temple's analysis is a sure-fire way to demonstrate "significant associations." Even the sloppy Carpenter and Avon admit: most of this difference stems from the different time frames used in the two analyses.
But the media will likelly not pick up on this. After all the headline of the WSJ article regarding this issue is: Scholar Fixes Flaws, Defends Finding of FDA Errors In Too-Hasty Approvals
The WSJ article missed the sleight of hand Carpenter and Avorn use to 'fix' things...
Diabetes drugs should face tougher safety standards that could cost manufacturers millions but protect patients from unforeseen heart risks, a government panel has recommended.
The Critical Path is all about determining who should get what drug based on predictive markers... Nissen, the media and the pols are all about fearmongering. Test 'em all.
"The majority of the panel said drug companies could begin safety testing before they submit drugs to the FDA, and finish the studies after the drugs are on the market. The testing would take an estimated five to seven years to complete, and likely cost tens of millions of dollars."
Oh really? And which patients will you expose to the additional risk while being treated to diabetes? Or the so-called risk since it is unclear if there is a risk at all or which patients are at greater risk. This is the result of Tabloid Medicine driving out good science and medical progress.
Meanwhile Nissen made this incredibly ignorant statement:
FDA is operating under ''the irrational belief that lowering blood sugar using virtually any pharmacological means will produce'' better results for patients."
Actually, that is what Nissen said -- we already have enough drugs to do the job. The FDA has never practiced medicine but has data showing that reductions in blood sugar do keep people alive longer. Nissen care to dispute that?
The danger of course is that this brutalization of medical science will spread to other diseases....Will the grownups at the FDA do the right thing and strike a balance for science?
''The fallacy here is that we will never know everything we'd like to about a drug before it goes on the market,'' Dr. Ray Woosley, president of the Critical Path Institute in Tucson, Ariz., said in a phone interview Tuesday. ''If we held up drugs until we did know everything a lot of people would die.''
www.nytimes.com/aponline/health/AP-Diabetes-Drugs-Heart-Risks.html
Pfizer, according to the Wall Street Journal. “hoping to temper criticism that it's improperly influencing doctors, is eliminating direct financial support for medical-education courses that are offered by third-party companies.”
"The reason we're not going to directly support them has to do with mitigating the perception of a conflict of interest, if a direct payment is going from a company like Pfizer to them," commented Cathryn Clary, vice president of U.S. external medical affairs.
Okay, so let’s get this straight – this is being done not because anything was amiss or non-compliant or because there’s too much CME going on out there – but because of political pressure.
Senator Chuck Grassley, ranking member of the Senate Finance Committee, said in a written statement: "My goal is to strengthen the system by shedding light on the financial relationships that exist between industry and medical doctors, medical education programs, medical journals, and medical research. … Public scrutiny can do a lot to bring about necessary reforms."
Pharmaceuticals
Statin Makers Bet Big On Imaging Technique
ORLANDO, FLA. - Trying to get a leg up in the $22 billion market for cholesterol medicines, drug companies increasingly are turning to an imaging technique that allows researchers to see how much plaque is building inside arteries. Several of the biggest players are funding major research studies, and--in an unusual twist--many of these clinical trials are being run by the same cardiologist: Steven E. Nissen.
In retrospect, we realize that it is not unusual at all just...business as usual.
www.forbes.com/2003/11/10/cx_mh_1110merck.html
From today's WSJ:
"Cardiologist Steven Nissen of the Cleveland Clinic said the FDA should require companies to prove their drugs don't raise risks of cardiovascular disease before they are approved.
Dr. Nissen said there are more than enough diabetes drugs on the market that lower blood-glucose levels, and now is the time for the FDA to raise its standards.
"Merely lowering blood-glucose levels in diabetes is too simplistic," Dr. Nissen said. "We must reduce the complications of diabetes, including cardiovascular disease."
online.wsj.com/article/SB121495996433621583.html
Dr. Nissen suggested that in addition to requiring more preapproval studies, companies should have large, long-term studies in place when a drug is approved to monitor whether the drug increases the risk of cardiovascular disease.
Why stop at diabetes drugs? If you apply Nissen's logic to any illness "there are more than enough drugs" out there to treat everything under sun. And since every drug has some cardiac risk, why not subject them all to increased long term clinical trials (that Nissen would conduct of course) to look at the problem.Let's set aside diabetes which is not just killing people here but worldwide. And let's set aside Nissen's failure to acknowledge that by claiming there are more than enough drugs he is ignoring the fact that diabetes requires individualized treatment but that new medicines will be developed (we hope) around more particular and preventive approaches, etc., etc. and that diabetes is not just a cardiovascular disease but part of a larger disorder that must be treated with as many tools as possible. Would you want an FDA commissioner who would say "we have enough drugs for...."? I am sure there are some who believe that, including Marcia Angell, but not many real physicians and scientists.
I would love to see that statement thrown back at him.
Next, what are the implications of his approach to access to medicines for patients?
Here's what the lead medical officer who reviews diabetes drugs at the FDA said according to a reporting in Bloomberg News
"Conclusive evidence of cardiovascular benefit hasn't been established for any drug for Type 2 diabetes, despite several large, long-term trials," Hylton Joffe, lead medical officer in the FDA's Division of Metabolism and Endocrinology Products, told the FDA panel yesterday.
Requiring heart assessments, especially before FDA approval, would add years to drug development because it takes that long for damage to show up. There also are ethical and logistical questions about how to organize studies because patients don't want to be in a comparison group getting a dummy pill and usually require multiple medicines as their disease progresses, Joffe said."
www.nj.com/business/ledger/index.ssfFrankly, I don't think Nissen -- who simply engaged in fearmongering over Avandia and drugs for ADHD -- couldn't care about the ethics of the matter.
If Nissen were FDA Czar, here's what patients could expect:
Add years and billions to the cost of new drug development.
Say good-bye to the Critical Path.
Let millions of people who are dying of and suffering from any illness with a drug in development that may have a cardiac side effect that can be found in any amount of any correlation wait while some pet meta-analysis is verified. So that includes drugs for:
Cancer
Alzheimer's
Schizophrenia
Parkinson's
HIV
Diabetes
And stem cell research of any kind...
I hope at least patients are paying attention.
FDA Steps Up Security for Advisory Committees
By Kate Rawson
FDA advisory committee meetings are not supposed to be like episodes of the Jerry Springer show. And for good reason: One is a scientific discussion of the benefit-risk profile of new drug or indication. The other is a television tabloid talk show with topics in such poor taste that our own corporate content filters won’t even let us access the website.
But it was Springer-like behavior at a recent meeting (featuring a threatening rant by an apparently intoxicated speaker during the open public hearing) that led FDA to impose new security measures to protect the agency’s expert panelists. While FDA hasn’t made a formal announcement of the policy changes, Office of New Drug Director John Jenkins discussed the new procedures at the Drug Information Association’s annual meeting last week.
“We have put in place some new measures to help improve security at meetings,” Jenkins said. “If we anticipate that there may be an increased need for security at a particular meeting because it is a particularly controversial topic, we may have additional security procedures.”
Those procedures include:
1) Creating a physical barrier by roping off the committee from the public. The intent, Jenkins said, is “to put some separation between those who might become agitated in the audience and committee members.” (For taxpayers, it carries another benefit—preventing the public from sneaking pastries off the committee’s breakfast tray.)
2) Increasing the presence of security guards in the committee room—both in uniform and street clothes.
3) Reading a statement at the start of the meeting about “good rules of behavior.”
There have been kerfuffles at advisory committees before, especially when the drug under review would be used to treat a rare or life-threatening condition. The heckling of FDA commissioner David Kessler during the 1996 advisory committee review of Abbott’s ritonavir, the first protease inhibitor for HIV, comes to mind.
And in very rare cases, FDA takes extraordinary steps to protect committee members. That same year, the review of the abortifacient RU-486 was held in an unused warehouse in the middle of a remote industrial park in
But this is the first time that FDA has felt the need for a comprehensive plan to ensure the security of advisory committee members. And it’s the biggest change to the advisory committee process since the agency altered its conflict of interest guidelines last year.
The trigger was a May 2007 review of IDM’s mifamurtide (Junovan) for the treatment of osteosarcoma. During the open public meeting, an apparently intoxicated individual made threatening statements to
Later in the meeting, Hussain and other committee members pointedly suggested that FDA establish greater security measures. (Hussain, it should be noted, has had her share of controversy in committee rooms. Last year, she was also one of four votes against the approval of Dendreon’s Provenge, a decision that led to threatening e-mails, phone calls and letters.)
For drug sponsors, the new procedures aren’t likely to have significant practical implications. But they are indicative of the intense public interest in drug development, and the pressure to discover new cures and keep unsafe products off the market.
We should note that the majority of meetings aren’t controversial and hence don’t require significant security procedures. But, as Jenkins noted, “there have been some incidents where that decorum has not sustained itself, and we’ve felt the need to institute procedures to maintain the safety of our advisors.”
Hence the rope. Of course, roping off the public isn’t the only way FDA can ensure the safety of those present at advisory committee meetings. Given some of the disputes between FDA officials on drug safety issues (remember the Arcoxia meeting? The Avandia meeting?), perhaps that rope could be put to better use elsewhere.
Wouldn’t that make a good Springer show?
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.
