House Subcommittee To Hold Drug Safety Hearing
47 CommentsBy Ed Silverman // March 5th, 2010 // 8:32 am
A hearing on drug safety is scheduled for next Wed., March 10, and will be held by the House Energy & Commerce committee’s subcommittee on Health. And the featured speaker will be deputy FDA commish Josh Sharfstein, as well as other FDA folks, according to The Pink Sheet.
No particular reason was cited, but the impetus for the hearing isn’t being attributed to Avandia. You may recall the GlaxoSmithKline diabetes pill was the subject of a recent Senate Finance Committee report that found internal dissent among FDA staffers over what to do about cardiovascular risks (see here). Importation, however, is expected to be on the agenda.
The hearing will be held because the committee hasn’t had any public discussion of drug safety since the FDA Commissioner Margaret Hamburg took office last year, according to the Pink Sheet. Hamburg arrived in the wake of various safety scandals, notably the Heparin blood thinner, that prompted Democrats to harshly criticize the agency (background here).
Condor
Pop the popcorn folks, this will be good watching!
sven
Ed:
You are a bit lost. Hamburg joined FDA well after heparin issues were resolved.
Condor
Hello Sven —
I think most people understand the phrase “in the wake of. . .” to refer to the past. [Hands Sven a clue, here:]
The boat’s “wake” is found behind the boat, as it travels, thus anything in its “wake” — is definitively. . . behind it.
Namaste, just the same!
Great story, Ed.
sven
Condork: What kind of boat do you have that leaves a wake for 18 months? Commissioner Hamburg joined the agency in the wake of the 1906 Food and Drug Act? That’s in the past but doesn’t quite work here does it smarty pants????
JaT
Do you know if this will be on C-SPAN or something, Ed?
Condor or "dork"
A very large one, Sven — QE II ish, in fact — more of a ship than a boat — but why quibble? Your perspective differs — cool — so be it. No need to get all bent over it.
JaT —
The hearings will very likely be livestreamed on both CSPAN II and on Chairman Waxman’s US House website.
Namaste
JaT
Thanks Condor.
I have to say, I thought you were bragging for a split second there, your comment following that moniker. Dork being a part of a whale’s anatomy.
Tachi Yamada
Why are they having hearings on drug safety? Is there a problem or something?
patrons99
Tachi - “Is there a problem or something?” You’re kidding aren’t you?
http://www.pharmalot.com/2010/02/these-drugs-generated-most-adverse-event-reports/
There are enough drug, biological, and device safety “issues” to warrant at least quarterly, if not monthly hearings. Substantive hearings. Not just kangaroo courts. Not just kabuki theatre.
Josh
/me teaches patrons how to use google….
Justice in MI
I assume this follows the recent GAO on enforcement and also the 2009 update on drug safety which was not sanguine. Wondering if also has health care reform implications.
Condor
JaT — the witness respectfully invokes his constitutional right to avoid self-incriminating testimony — as compelled by the state.
That is, I’ll “Take 5, for Fighting!”, Tillikum-style. Sorry.
Namaste
PS: Great spoof, Yamada!
Condor
JaT — this page ought to have one or more live webcast links, to Chairman Waxman’s aove-referenced hearing — by next Tuesday night. It will go live at 2 pm EST on Wednesday.
Namaste
JaT
QE II ish, in fact — more of a ship than a boat — but why quibble?
I’ve been laughing about it all day.
Thanks for the link & the chuckle.
Anne PME
Ok, so what do you think that they will talk about at the hearing?
Does anyone think that someone will bring up smelly medicine? I was thinking that it might be interesting to talk about why certain prescription medicines like some brands of metformin and levocarnitine sometimes smell like dead fish.
What about medicine that disentigrates? this might be an interesting discussion…you could headline it with something like….medicine that melts in your mouth, and not in your intestines…
Do you think that Daniel Troy will be watching?
Justice in MI
Damn, I keep feeling like the skull at the banquet, but I am not sure this will be a very interesting hearing. Sharfstein, whom I like, will summarize the various initiatives FDA is taking since FDAAA, acknowledge there is a long way to go, bemoan the past, maybe raise funding issues, and the Waxfolk will pretty much say exactly what you’d expect them to say.
I hope I’m surprised.
Condor
I hope you are too, JiM.
N’maste
patrons99
A fascinating infomail article from Vera Sharav of the Alliance for Human Research Protection on March 5, 2010, titled “Shame on the Editors of the Washington Times” regarding an OpEd piece by “Doctor” Gilbert Ross, is on point:
“Were the editors of the Washington Times asleep at the helm when they
disseminated an OpEd tirade against Senator Charles Grassley, Senator Max
Baucus, and FDA’s senior safety officer, David Graham, MD. without
disclosing relevant facts that (at the least) raise questions about the
author’s integrity ?”
http://www.ahrp.org/cms/content/view/673/9/
http://washingtontimes.com/news/2010/mar/04/when-senators-play-doctor//print/
The “good doctor” Ross and The Washington Times appear to have set the bar at a “new all time low.” I’m grateful to Ms Sharav for calling attention to this article. It is really quite astounding.
John
Like anything else, I think you have to judge the piece by the reliability of the data sources quoted and the tightness of the reasoning employed. If these are good, being a convicted felon is immaterial. On the other hand, if Mother Theresa quotes doubtful sources and employs faulty logic, she’s not going to convince me of anything.
Just to be clear I am not defending the author because he agrees with my point of view that very little that Waxman does is helpful, I’ll say that employing the standards described above, I did not think this was a particularly enlightening piece.
Oscar
Overseas Pharmacies are listed as foreign online pharmacies that help provide good products and excellent medicines at an affordable price and warranty products, we can find different pharmacies online and findrxonline, findyourdrug, pharmaspider, chronic-anxiety, cheaponmeds, etc. These are some of the most secure, reliable, and where its necessity is a registered trademark.
Condor
So — you’ve got me thinking, here, patrons99 — all that current FDA rules governing NDAs presently require is this — as to signatures:
. . . .Sec. 314.50. . .
(5) The applicant, or the applicant’s attorney, agent, or other authorized official shall sign the application. If the person signing the application does not reside or have a place of business within the United States, the application is required to contain the name and address of, and be countersigned by, an attorney, agent, or other authorized official who resides or maintains a place of business within the United States. . . .
(vi) A summary and updates of safety information, as follows:
(a) The applicant shall submit an integrated summary of all available information about the safety of the drug product, including pertinent animal data, demonstrated or potential adverse effects of the drug, clinically significant drug/drug interactions, and other safety considerations, such as data from epidemiological studies of related drugs. The safety data shall be presented by gender, age, and racial subgroups. When appropriate, safety data from other subgroups of the population of patients treated also shall be presented, such as for patients with renal failure or patients with different levels of severity of the disease. A description of any statistical analyses performed in analyzing safety data should also be included, unless already included under paragraph (d)(5)(ii) of this section. . . .
So, this would be reworked to require that the CEO, and CSO both certify, that — after due and diligent inquiries — all the required data is included, and is truthfully and completely presented, free of any material omissions. And, I suppose, that after asking for the reviews of responsible INDEPENDENT science advisers, no other materially important data ought to be produced, ot sought — based on the then-currently available information about the MoA.
Hm-mm-m [I wonder -- is Salmon around? What does he think?]. . . what about that?
Namaste
patrons99
Condor - I really do hope that someone on the House Subcomittee reads this thread, particularly your comment (above), prior to the Drug Safety hearing. I hope that they also link to your most recent comments at a related pharmalot thread (link provided below), because they are more than just a comments. You seem to be making a substantive recommendation for legislative reform, which I believe has merit (of course, I’m not an attorney).
http://www.pharmalot.com/2010/03/fda-oversight-of-criminal-investigations-is-lax/#comments
Justice in MI
Right on, 99!
What’s amazing, when you look back, is that essentially the same list of FDA reforms has been proposed recurrently since the 1970s. The great bulk have never happened. (Several were in early versions of the FDAAA but squeezed out during various “reconciliations.”)
As I keep saying, the most important involve appropriate funding and empowering of the agency. It appears that the Wash Times dude is trying to ride the Big Brother Paranoia train, which has also been recurrently invoked over the years to limit FDA’s authority. (No one did it “better” than Newt and the WLF during the 90s. Commish Kessler was, literally, called a murderous thug.)
Justice in MI
Some may be interested in Sourcewatch’s piece on the ACSH of which Ross is “Medical Director.”
http://www.sourcewatch.org/index.php?title=American_Council_on_Science_and_Health
They have had an ambiguous relationship with big tobacco over the years, but always close to conservative family foundations (Olin, Scaife, et. al.) They appear to be heading further right, and one of their directors is best known for initiating much of the “death panel” accusations.
patrons99
I hope that our lawmakers, when they read the Ross OpEd in the Washington Times, are able to see it for what it really is…pure pharma-sponsored bilge, written by no less than a felon, an ex-con.
Real question: how widely-read is the Washington Times? This could be a defining moment for the Washington Times. Why don’t they retract the piece? I am sure that there are some readers of the piece who will never realize how tainted and conflicted the article really is.
Justice in MI
My impression is that the Washington Times is a “niche” newspaper, and this is reasonably standard fare for them.
I wouldn’t describe the piece as “pharma-sponsored,” but it would be supported by a wing within the industry.
Over the years, though, most in the industry have concluded that trashing the FDA is better for the pols than for themselves, and that the FDA has saved their butts more often than the contrary. So, for example, said the chief lawyer representing Grunenthal, the manufacturer of thalidomide. “Frances Kelsey saved our company.”
JaT
Of course, for a CEO to certify anything much would involve a big leap of faith, as some (ie: Kindler) have no background in science.
The other problem being that gaining approval on a NDA does not mean that a drug will remain precisely as it was when the application was made- which offers drug makers the famous “we sometimes have problems getting quality ingredients” defense. Which I suspect is more of a cost saving measure by purchasing departments.
If anyone has dealt with purveyors of any kind of goods, you know what I mean. Several providers submit lists of the products they provide and then purchasing departments place orders based on cost per unit, where the cut is (if buying in mass quantities), make deals on one product if you buy other products from them, and so on.
When I called Pfizer they told me there had been a bidding war over an ingredient. At about the same time- when FDA had their CRADA with Pfizer resulting in the reformulation of Dilantin- FDA made the statement that bovine based magneseum stearate would be widely replaced with a vegetable based product, as a major manufacturer of the bovine based product had discontinued making it. FDA indicated that they didn’t know what the result of that change might be, but that the ingredient, even used in small amounts, plays an important role in product quality.
Hmmm, that doesn’t mean that the bovine based product is no longer available. And it had nothing to do with Pfizer saving us from mad cow disease. From my perspective- and from the explanation of Quality by Design- which is designed to set minimum standards- it is not so much about what you use in your product, but rather, the end result. This led CDER to that CRADA. Which would all be fine except that the science doesn’t investigate anything more than the most simple of absorption and/or dissolution rates.
I could go on and try to explain other excipient qualities, as I took a bit of a crash course, where density of different grades of lactose (for example) has an effect on shelf life and absorption, but I think you get the point.
It is about the delivery of the active ingredient, yes, but also about complications that might arise not being investigated at all.
So what I am hoping to see in these hearings is that a change in excipient quality is no longer passable by such limited studies. And that products have to remain as they were when they gained NDA approvals. I would also like to see FDA have to tighten the criteria for generic applications, as +/- 20% or whatever it is, obviously presents a danger from lot to lot. If a doctor prescribes a medication one time and it works, then the next time it doesn’t work, making a good diagnosis becomes nearly impossible.
(not running a spell checker and wrote this in a rush so please forgive any mistakes.)
Justice in MI
Googled around and found that Wash Times founded by Rev. Moon/Unification Church and split from them in 2009. Circulation under 100,000, about 1/7th of Wash Post.
JaT
I would also like to see somebody being held accountable for conducting research on myself and others that share my situation. It was completely reckless and unnecessary. Reckless to the extent that someone was having our posts removed from the Epilepsy Foundations forum. That just wouldn’t occur if everything was above board.
JiM, you explained where the money goes when drug makers pay fines for criminal activities. To those who were defrauded. I think for people to be fed a different product under the same name, as a captive audience because of the dangers of not taking the product at all, pretty much applies.
“New Look” indicating (and Pfizer said as much) that it was only that- was fraud in my opinion.
patrons99
O.K., perhaps we should give Dr Gilbert Ross, the author of the Op-Ed defending GSK and calling the call for removal of AVANDIA from the market a “trumped-up scandal”, the benefit of the doubt. While incarcerated he may have found religion, and now practices “charitable giving” of gratuitous pro-GSK OpEds as a means of redress for his prior wrongs. Now he’s completely at peace with himself and he’s simply giving back to society. The “good doctor” Ross and GSK are simply “kindred spirits”, nothing more.
What pharma, including GSK, really fears the most by way of FDA reform is “an independent drug-safety divison within - but separate from - the FDA.”
To quote from Dr Ross’s OpEd,
“The bureaucratic agenda behind this gratuitous and unscientific attack is spelled out in the report: The authors want to create an independent drug-safety division within - but separate from - the FDA. Even though our drug regulators are the world’s most demanding, the senators and Dr. Graham want even more stringency. They have long been advocates for an even more cautious, risk-averse FDA, elevating safety above all other concerns - even at the cost of sacrificing innovative, lifesaving new drugs.”
Heaven forbid that FDA would dare to elevate safety above all other concerns.
http://www.guardian.co.uk/business/2010/feb/22/glaxosmithkline-avandia-concerns-senate/print
http://www.guardian.co.uk/business/2010/jan/10/glaxosmithkline-swine-flu-revenue-boost/print
http://vactruth.com/2010/01/25/doctors-vaccinate-for-profit/
patrons99
In an article by Allen Jones on March 4, 2010, titled “Doctor Who Criticizes Senators For “Attacking” Pharma in Washington Times Article Failed to Mention He’s Served Prison Time for Fraud”, it states:
“Ross is identified as “medical director of the American Council on Science and Health,” but Ross discloses no financial ties to GSK. The ACSH website however acknowledges that 40% of ACSH’s budget comes from “corporations.” Does this include Pharma funding?”
Hmmmm. Good question!
http://www.cchrint.org/2010/03/04/doctor-who-criticizes-senators-for-attacking-pharma-in-washington-times-article-failed-to-mention-he%E2%80%99s-served-prison-time-for-fraud/
Justice in MI
The ACSH opts not to disclose its current corporate sponsors.
In the 1984 report on Sourcewatch, linked above, a number of pharma companies were listed, including: Merck, J&J, BMS, Warner-Lambert, Searle, Ciba-Gigy, and others.
So were many other companies. Given the group’s attack on global warming, etc., etc., not surprising that big oil is also substantially represented.
patrons99
JiM - Do you think we could find something more current than the 1984 Annual Report info from ACSH that you cite? The 1984 info is most impressive…a veritable “who’s who”. I’m a little surprised not to find GSK or the Gates Foundation on the list of sponsors, but perhaps I just missed them, somehow. Of course Pfizer made the list. No surprise there.
patrons99
Just add Novartis and Baxter to the list and you’ve just about got the entire NWO. Oops! Did I really say that?
Justice in MI
Here is a list from 1991 and a partial one from 1997. Lilly and Abbott join in. The various pieces of what is now GSK were never US-based companies, right? Perhaps that’s why they do not appear.
As noted here, during the 90s the ACSH stopped disclosing its donors.
http://www.cspinet.org/integrity/nonprofits/american_council_on_science_and_health.html
patrons99
Thanks JiM - Yes ACSH is a behemoth. I note that Monsanto (our food supply) is on the list. One day soon we might find our names (the food supply) on the list, appearing as Soylent Green. Where is Verichip and PositiveID? They’ve got to be “sponsoring” someone!
patrons99
Based upon the written statement of its “medical director” on March 4th, it can now be stated that ASCH endorses an even less cautious, risk-seeking FDA, lowering safety below all other concerns, so as to promote “innovative” lifesaving new drugs. What’s wrong with this picture?
Justice in MI
Tony Blankley (sp?) who often pops up as a commentator was, I believe, an editor of he Wash Times at one point. He was also a campaign director for Newt Gingrich. In the mid-90s, in the midst of the deregulation craze, Newt’s explicit goal was returning the FDA to its pre-thalidomide status–essentially, dissolving all the changes brought by Kefauver-Harris. The votes were there to do it. Pharma’s own pull-back had partly to do with why it didn’t happen.
The theory, which Milton Friedman and others in that school endorsed, is that the “market” is a better regulator than the feds, and that “bad actors” will fall away, while “good actors” will get out sooner.
As we know, there are a not small number of people who still believe that.
pharmavet
Justice, the idea that markets are self-regulating dates back to Ayn Rand, who advocated that government and markets should be constitutionally separate. Her disciple, Alan Greenspan was also a believer in the self-regulating nature of the markets. Greenspan also felt that securities fraud was not a major problem, because self-regulation would weed out the bad actors. Of course we all know by now that the bad actors, with the assistance of Bob Rubin and Larry Summers under Clinton, indeed won out when they failed to regulate the derivatives market. Such failure was a major cause of the recent economic collapse.
These activities will, unfortunately continue. The reason is that not only aren’t government and markets separate, there is a direct feedback loop between them. The Wall Street folks do time in Washington, where they make sure that favorable regs are put in place. Once the favorable regs are in place, they go back to the Street, where they are able to capitalize on the favorable laws that they helped to pass. Unless this feedback loop is broken lor changed this behavior will continue ad infinitum.
Condor
Patrons99 — I did write Karen Lightfoot, and received a cordial reply — making the suggestion about CEO certifications for NDAs at FDA, for this hearing.
As to JaT’s concern about Kindler ot being a scientist, I hear ya’. However, he is also NOT a CPA (nor are most CEOs of public companies), but still he signs the Sarbanes-Oxley certifications.
The gist of them — and the proposed NDA certification (just conjured up by patrons99 and me!) — is that the CEO must satisfy her/himself that she/he is asking the right questions, and getting truthful answers, from an organization — with a clearly defined process for sniffing out mistakes — or worse.
If need be, the CEO can be encouraged to retain a truly independent expert to review the process, for her/him — and rely on that expert. [Bonus -- a right to work act for recently furloughed pharma science experts, reincarnated as consultants, late from Wyeth, Pfizer, Roche, Isis, Merck and Schering -- and so on!]
That the CEO can — and should — do.
We shall see.
Justice in MI
Entirely agree, Vet. As an anti-preemptor, I like to quote Friedman on the necessary role that lawsuits play in market “self-regulation.”
Elsewhere in the news, as many will know, Vera Shavner has sent out an “infomail” (not yet on the AHRP site) that the Wash Times issued a statement “regretting” (my translation) publishing the op ed by a convicted felon and suggesting they would be unlikely to publish another piece that came from the ASCH.
JaT
Reading the Briefing Memo- I have little hope that they will address the concerns I have.
http://energycommerce.house.gov/Press_111/20100305/Briefing.Memo.2010.3.5.pdf
What a surprize. If everyone is cool with their drugs not being consistent, no longer knowing if they are going to work the same way from lot to lot, or if they might encounter a new problem because of a change in the quality of ingredients, who am I to say? Ugh! I’ve been at this for over two years.
See, when Pfizer asked us to send product to Puerto Rico so they could examine it, the answer was that the product met their quality criteria. Nevermind that the criteria had changed. FDA can inspect the plant a billion times and find everything to be fine.
I’d give up, except, damn this is important. It is also much bigger than me.
patrons99
For those who may be interested, here is the followup infomail from AHRP on March 6, 2010, titled “Washington Times Response to AHRP”.
http://www.ahrp.org/cms/content/view/674/9/
“…it is difficult to excuse the Washington Times for its repeated selection of Dr. Ross and the ACSH…”
JaT
So what did we learn today?
(my take)
We learned that Senator Castor has been paying attention- asking if the committee should be doing more to make sure reimported domestic drugs from places like Puerto Rico are safe and effective. And that Dr. Sharfstein doesn’t think so, at this time.
~~~Just say Dilantin for the love of Pete.~~~
We learned that FDA wants to set markers for safety. Upgrading regulatory science.
~~~Which means what? Another change in AUC for drugs that didn’t test well under the first study?~~~
We learned that some on the committee do belive that drug makers should be better verifying the ingredients that they use (yay). And that FDA isn’t sure if it can require the implementation of Quality Risk Management Plans by those companies.
We learned that counterfeit drugs are a much bigger concern to most than the safety of legitimate, FDA approved, drugs.
Though someone did mention how people might be pushed to buy counterfeit drugs because of the inability to afford legitimate products (yay, excellent point).
We learned that FDA believes that electronic records will help them to better evaluate problems.
~~~Which would be great if doctors reported the problems properly- while FDA has a way of ignoring the reports of those silly consumers.~~~
We learned that special REMS are in place for certain treatment areas and that the REMS program is under a bit of construction. Which goes along with setting markers. And that they have some understanding of a narrow therapeutic index.
~~~Despite that understanding (or did it occur to them after the fact) they did approved the reformulation of New Look Dilantin without review.~~~
Did I miss anything? Ummm, oh, did I hear that FDA doesn’t include the required drug company payments in their budget? Seems someone was either correcting or kicking Dr. Sharfstein during that part of the discussion- so who knows. Might want to keep that in mind during the debate over generic drug user fees.
Anywho…
JaT
Oh, excuse me, I think Ms. Castor is a state representative from Florida?
Condor
Here — if you have Windows Media Player (8 or better) loaded (blech!), is the video stream from today’s Safety hearing on the Hill. [I had intended to watch it, but my day job duties, such as they are, intervened.] I only dipped in and out of the stream just now, but watched all of Chairman Waxman — neither he nor anyone else talked about CEO certifications of NDAs.
Huge surprise. Not.
Namaste
Justice in MI
If I have this right, I was surprised to learn today that required phase IVs as revised via FDAAA have yet to begin. Does anyone know if, indeed, there has been any change on this to date?