Latest Drugwonks' Blog
The really sad thing about the new PhRMA marketing guidelines is that they, basically, match what Senator Charles Grassley is proposing. Talk about inside-the-Beltway groupthink.
Consider this – the big news is (are you sitting down) – no more pens or coffee mugs! Gadzooks.
(Is there a lobby for specialty goods manufacturers? We’ll soon find out.)
What's the attitude of the AMA is on this matter? It should be righteous indignation that the pfolks at PhRMA and too many members of the United States Congress, think that a physician can be bought for trinkets. Good thing these guys weren’t around for the negotiations over Manhattan Island.
But as silly and trivial as this sounds, the more serious issue at play is the caving in by the pharmaceutical industry to misguided political pressure. Silly in the instance of pens and coffee mugs perhaps – but what comes next? A “voluntary moratorium” on DTC advertising? The demonization of published articles on the off-label uses of medicines? It’s a long list.
When is a conflict not a conflict? If the answer is, “When Senator Grassley says so,” then the slope the industry is on is indeed a slippery one.
The only positive thing that will come from the Tchatchke Intifada is that pharmaceutical sales representatives won’t have to schlep them from office to office – thereby lightening their load, improving their gas mileage and decreasing the overall carbon footprint of the industry.
Where’s Nick Naylor when you need him?
British pharmaceutical giant GlaxoSmithKline PLC is taking the unusual step of giving government health-care systems a say in deciding which drugs advance in its research pipeline, a move it hopes will result in more products these customers will pay for.
Glaxo's new chief executive, Andrew Witty, said the effort is part of his drive to help the world's second-largest drug maker adapt to a tough pharmaceutical market. In recent years, soaring health-care costs have led insurers, governments and other drug buyers to tighten their belts.
Was Witty really surprised then by this headline:
Blow for GSK’s breast cancer drug
By Andrew Jack
Published: July 8 2008 03:03 | Last updated: July 8 2008 03:03
"The British government’s medicines advisory body has advised against the use of GlaxoSmithKline’s oral cancer drug Tyverb in the National Health Service, dealing a blow to the UK-based pharmaceutical group in its home country.
The National Institute of Health and Clinical Excellence (Nice) on Monday issued a provisional recommendation that Tyverb for advanced breast cancer did not meet its threshold for clinical and cost effectiveness. That recommendation could effectively rule out the UK market for the GSK medicine."
Tykerb is a pill that targets a subgroup of women who are HER-2 positive for breast cancer. GSK even told NICE it would only accept payment for patients who got better.
It still said no.
What new drugs do regulatory authorities want:
Close your eyes and what do you see?
Witty should know better than to hand the future of his company and that of patients over to those who care only about costs.
And now the agency has addressed it head on. From now on there will be no more gradations of approvability. Say hello to the “complete response” letter.
Sound familiar? It should, it’s the same concept behind BLAs. In other words, the agency is embracing the concept of consistency. Good move.
Think of “complete response” letters as pathways to approval – a regulatory MapQuest for drug approvals.
And just as with MapQuest, the other most important variable in reaching the desired destination is … where you begin.
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."
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.
