Grassley Decries ‘Vicious Attack’ In Newspaper Op-Ed
45 CommentsBy Ed Silverman // June 2nd, 2008 // 1:17 pm
Last week, Mark Thornton, a senior vp with GenVec, a small drugmaker that is developing a cancer med, among other drugs, wrote an editorial in The Wall Street Journal criticizing Chuck Grassley, the ranking Republican on the Senate Finance Committee, for asking the GAO to probe the FDA over approval of surrogate endpoints.
We pointed out that Thornton failed to disclose his job, but did identify himself as a former FDA medical officer and president of the Sarcoma Foundation of America, prompting a vigorous debate on this site (please see the comments). Today, Grassley issued a statement chastising Thornton for failing to make the disclosure, and for incorrectly describing his reasons for a GAO probe.
“…Thornton mischaracterizes and protests my asking the Government Accountability Office to determine if the FDA is carrying out its own policy of requiring follow-up studies on pharmaceutical drugs that have been approved based on surrogate end points…Surrogate end points are a valid way for the FDA to approve drugs…
“My recent request for an independent review of the FDA’s performance with follow-up studies on surrogate end point approvals is not part of a conspiracy to slow the approval of cancer drugs, as suggested by a drug company doctor. It is an effort to strengthen post-market surveillance by the FDA, to make the relationship between the FDA and drug makers less cozy as there’s been too much collaboration in addressing post-market concerns, and to see the FDA be moreforthcoming with information about drug safety and risks after drugs are on the market and more becomes known about them than can ever be learned from clinical trials or smaller-scale testing…”
“For cancer patients and others, follow-up studies on drugs approved through the surrogate end point method would give them more information about the drugs they’re taking. What’s wrong with that?”
Doc
Go get em Sen. Grassley, keep holding those pharma pheet to the phire!!!!
pg
“For cancer patients and others, follow-up studies on drugs approved through the surrogate end point method would give them more information about the drugs they’re taking. What’s wrong with that?”
There’s nothing wrong with that, Mr Grassley. People across the world, not only those in the US, are relying on you “holding those pharma pheet to the phire” as Doc puts it.
Don’t let the Drug Wonkers get to you. They’re just scared of what you can achieve :)
pg
“terrified” is probably a better word.
(DOH - Did I spell Wonkers correctly? I’ve seen it spelled with an a in various places and it looked much better that way)
pg
“…Drug makers and drug developers violate the public interest when they work to muzzle the scientific process and fight disclosure of newly emerging information about various pharmaceuticals in order to drive up their sales and profits…”
(From the full statement link)
Absolutely spot on. No wonder the old drug wonkers are terrified.
condor
Great minds think alike, it seems! I’ve set the Senator’s preply in easy-reading running text, for anyone who doesn’t have a PDF reader loaded [And, of course -- Great work, Ed!] right here:
http://shearlingsplowed.blogspot.com/2008/06/senator-grassleys-response-to-last.html
condor
Great minds think alike, it seems! I’ve set the Senator’s reply in easy-reading running text — for anyone who doesn’t have a PDF reader loaded on their laptop [And, of course -- Great work, Ed!] right here:
http://shearlingsplowed.blogspot.com/2008/06/senator-grassleys-response-to-last.html
CMC guy
While it is accurate that Grassley’s initial GAO request did focus on Phase IV follow up studies of drugs approved on surrogates the March 4th report by Ed, which appears directly from AP article, did imply a broader agenda (micromanagement is term I have seen used elsewhere). Is this a case of bad reporting or just an extrapolation of Grassley’s past actions? I do not have a problem of checking on commitments but to me a GAO investigation seems the aggressive path, as I believe other means possible to seek this information, and regardless of “limited” focus can see could get FDA entrenchment reaction along lines Thornton wrote about (although he should have framed such a context better).
Can of worms: did Grassley/Ed list or link the Senator’s campaign contributors? How can I judge his motivation unless I have those facts? Is the mere fact he is a 50 year politician enough to identify/question what’s behind this?
condor
CMC Guy — you jsut don’t. get. it. do. you?
Grassley didn’t hide any of his interests. Dr. Thorton did. End of [your] story.
Go check fec.gov — if you want Senator Grassley’s doation roster. Where is Dr. Thorton’s public web-site listing all his affiliations/benefactors? Ooops — he doesn’t have one!
Double oops! — the Wall Street Journal neglected to ask about his “other employments/entanglements” before running his hit piece.
Me? I prefer Ed’s brand of journalism — to the WSJ’s. Any day.
but I’m just nutty that whay — I don’t think newspapers should be “stenographers” of/for corporate press release fodder.
Roy M. Poses MD
For more comments on Thornton’s unwarranted enthusiasm for surrogate endpoints, and his undisclosed but relevant financial ties, and the undisclosed but relevant funding sources of the not-for-profit he leads, see Health Care Renewal:
http://hcrenewal.blogspot.com/2008/06/criticism-of-surrogate-endpoints-in.html
Ed Silverman
Hi CMC,
The pharmaceutical industry is actually one of Grassley’s top contributors, by industry, according to OpenSecrets, where you can check ‘contributions’ going back to 1989 or on a cyclical basis since then. Here’s the data for 2008…
http://www.opensecrets.org/politicians/industries.php?cycle=2008&cid=N00001758
And the March 4 post was an AP report and was credited appropriately to the AP. If something was inaccurate, I will address that, but unfortunately, I can’t respond to your statement about a broader agenda. I’ve reread the post, but not clear about what you’re trying to suggest. Let me know.
ed
Dr. B
The point is that surrogate endpoints may not be clinically meaningful. E.g. vytorin lowers cholesterol but is not shown to prevent heart attacks or slow progression of atherosclerosis. And pharma views science as a political game to manipulate the situation to extend profits, e.g. delay in release of the ENHANCE trial results for almost two years while vytorin was bringing in a billion a year. Another example is erbitux extending the lives of lung cancer patients by five weeks. Does this outcome justify the expense? I think that it is appropriate that these articles are in WSJ and the business section of NYT, since Wall Street seems to be the only ones who are benefiting from these expensive boondoggles.
CMC guy
Ed sorry to be unclear as the broader agenda is in reference to “attack on use of surrogates” theme which again was framed that way in the AP article (and by extension telling the FDA how to approve drugs). That is what I got fixed upon because I could/can see direct negative impact. To be fair AP story (and you) also did include quotes of those who did say it was not about surrogates but about follow-up and Grassley in this statement further offers specific refutation that they are valid. See how things spin, makes me dizzy.
I was actually poking a bit of fun regarding disclosure issue (which I should not because can be a critical info) since I contend can never have all the data anyway but thanks for the link. I had briefly looked on Sen. Grassley website but did not come anything along those lines and what I did see did not dissuade my jaded opinion of our politicians (based on materials may be he has some ex-pharma marketing people working for him)
CMC guy
oops: to clarify Grassley’s “specific refutation (of Thornton) indicating that they are valid”
pg
Condor: Thanks for setting the Senator’s response “in easy-reading running text” at
http://shearlingsplowed.blogspot.com/2008/06/senator-grassleys-response-to-last.html
Appreciated :) Fantastic response from Sen Grassley - though I’d think its going to bring out more and more of those who benefit from keeping the status quo. What a man!
pg
“The pharmaceutical industry is actually one of Grassley’s top contributors, by industry, according to OpenSecrets”
And hasn’t he put that money to good use!
I doubt those particular contributers are singing this little song:
http://www.youtube.com/watch?v=kFRuLFR91e4
Nathan
pg,
Thornton’s affiliations are all right out there in the open. (do a google search) He just didn’t reveal them in his article. Did Grassley reveal that the pharma industry is a major contributor to his campaign? No! Ed had to go to “OpenSecrets” to find this. Why didn’t he reveal it? Why aren’t you and Ed upset about this? Isn’t this fact very relevant to his investigation of the pharma industry? Maybe he should be more closely scrutinizing the industry but due to these contributions he is just doing “lip service” by limiting his inquiry to follow up oncology studies.
It’s fine to demand full disclosure. But you should demand it from EVERYONE - not just pro-pharma people.
By the way, pg, I expect a full disclosure from you in your next post. I want to know what exactly your motivations are.
Full disclosure: ” “I work for a pharmaceutical company with an income of approximately $100k per year. I have roughly $10,000 in company stock. I have approximately $65k in my 401k, of which ~10% is invested in the healthcare industry and an unknown percentage in pharmaceutical stock. My grandmother died from cancer and my grandfather from Alzheimer’s. My father-in-law is a colon cancer survivor. I have two young children and I wish them to grow up in a world with better treatments for diseases than we currently have. “
pg
I have never worked for a drug company, I have no affiliations with any, or with any alternative health thing, nor am I am a scientologist. I am not anti pharma (which might seem surprising) or anti psychiatry (ditto).
I make NO money whatsoever for what I do, my time and internet costs are at my own expense.
I am very much against the harm done to people across the world by an industry that has been allowed to swing right out of control that has, on so very many occasions with so many drugs, lied about and hidden data which is crucially needed by physicians in order that they can safely treat their patients by weighing up the benefits -v- risks accurately and monitoring for ADRs.
I am disgusted at the KOL’s and other involved who knowingly sell out to the drug industry’s dishonest methods, and there are many of those.
I am appalled that decisions of judges in one nation to assist in the hiding of that data by issuing protective orders not only harms the people of that nation but of all other nations.
I am very much against the harm done by the “stifling” of academic debate without which there is no science, and to the effect on the lives of the academics who attempt to bring the data to light due to the methods used in stifling debate.
I wish all children to grow up in a world with better treatments but this cannot be achieved while the situation outlined above is allowed to remain, or worse, increase.
pg
As for Mark Thornton MD, perhaps you could leave a link leading to his disclosures as I haven’t found any. Hopefully the link will not only cover disclosures already covered, but those earned from his directorship of drugwonks, though I feel that this is unlikely as drugwonks themselves do not disclose their funding.
pg
The drug industry COULD contribute a great deal to the quality of life - if they chose to act in an honest and scientifically open way. Those who already do so have my support though unfortunately those who do not cause so much devastation to the lives of others worldwide that the spotlight naturally ends up shining directly on them.
pg
To add: I’m not affiliated with any law firms, nor taking part in any litigation. My interests are, or more accurately were, very much aligned towards the arts, though that does not exclude an interest in science or imply a lack of capability in grasping scientific principles.
pg
Senator Grassley contributions seem, as Condor said, to be openly available on the fec gov website. Perhaps Ed was busy/tired - which would be understandable given the work he does on this site - and found it easier and faster to access OpenSecrets rather than go through searches on fec gov - I’ve no idea.
http://query.nictusa.com/cgi-bin/can_give/2007_S0IA00028
“Presented by the Federal Election Commission
Committees Who Gave To This Candidate
GRASSLEY, CHARLES E
THE CANDIDATE
GRASSLEY COMMITTEE INC
PRINCIPAL CAMPAIGN COMMITTEE OF THE CANDIDATE…”
pg
I give up finding disclosure by Mark Thornton for now. When I think a search will bring disclosure up, what actually does show are things like this example:
http://www.thecbce.com/upcomingActivities_detail.aspx?act_id=248
“Sarcomas as a Paradigm for Personalized Medicine and Targeted Therapies: New Directions and Innovative Approaches to Diagnosis and Treatments
June 1, 2008…”
“…The following faculty have declared they have no financial relationships that require disclosure:
Ramzi Dagher, MD
Lee J. Helman, MD
Brian Rubin, MD, PhD
Mark Thornton, MD, PhD”
I don’t know for sure, but would have thought that there’s a probability that Mark Thornton being a senior vp with GenVec who are developing a cancer med might be something that should be disclosed, given the title of the paper.
pg
To add further: I survive on a fraction of $100,000 pa and own no stocks in the healthcare or pharmaceutical industry, or in any other industry.
Nathan
pg,
Thanks for your full-disclosure. However, you left out some vital information. Have you taken an SSRI before and suffered negative side-effects? Has anyone in your family? Do you run any anti-pharma blog site or have personal affiliations with those who do? Full disclosure isn’t only for the pharma folks. I want to know what vested interest you have in drug “safety”. I’m quite certain your interest is not entirely altruistic. Those reading your posts deserve to know your motivations.
pg
How could I run an antipharma website Nathan? I am NOT ANTI-PHARMA. I am anti scientific misconduct, anti fraud, anti harm and I believe I have expressed my motivation very clearly above.
I haven’t left anything out that would be a vested interest for me, where I am looking after MY interests, if that is what you are implying.
Unlike yourself, by posting here I am doing anything BUT looking after my own interests. It would be in MY best interest to avoid the risks associated with posting anything about pharma dishonesty, don’t you think?
Goodnight.
Nathan
Very good, pg. Now we know you are entirely altruistic in your posts and only looking out for the good of others. I’ll continue posting my own self-serving posts. At least my motivations are clear. I’m in the pharma industry and therefore I’m a cruel, heartless, money-grubbing elitist.
Interestingly you did not answer my questions about SSRIs. You have no personal vendetta to settle against pharma? I could have sworn you once said that you or a close relative of yours was harmed by SSRIs. That certainly is relevant and worth disclosing. But I could be wrong.
Anne
Good for you, pg. Nathan seems to feel that somehow it is a bad thing to have had one’s son killed by Lilly’s Zyprexa, to have had one’s life shattered by a company that hid the lethal side effects, to not have been protected by a totally dysfunctional FDA, to have a Congress that has in the main been bought off by Pharma, to have post-cheerleader drug reps in my doctor’s office, flirting. That somehow it is a bad thing that I am a board member of an organization that battles against false clinical trials, ghost/drug company-written journal articles,and dangerous drugs given off label, doctors who are paid many thousands of dollars to shill drugs for this or that company. Perhaps he also feels something might be wrong with the fact that I have dear friends whose children committed suicide on SSRIs or died of profound hyperglycemia or pancreatitis from Zyprexa. I guess the only thing that would matter to him would be to know that no one pays me to be in this uphill battle, because there are other things he also wouldn’t like……I consider Senator Charles Grassley the star of the Senate. The shining star who battles for drug safety. Sometimes the only star who fights for this. It helps to have a few heroes. I often wonder how defenders of this industry sleep at night but it seems to be the entrenched American way. The Golden Rule is gone, and has been replaced by the bottom line.
pg
Nathan, I don’t have a “vendetta” to settle against pharma. As I have just stated, if I were to work in MY best interests I (and many others like me) would be keeping silent, OK?
You’re very welcome to your own idea of who or what I am and yes, you could be wrong. End of subject.
pg
Thanks Anne and I quite agree with your points.
Jane
Nathan,
Interesting how you have taken a psychotropic class medication to try and discredit pg. Why not ask if she/he has ever suffered a negative effect to any medication? Also, if you are requiring a list of medications taken in your disclosure rules, why didn’t you list all medications you have taken?
Anne
Jane, maybe he is a rep for Lexapro, or Paxil, or Zoloft, or Cymbalta, or Prozac, or Celexa, or on and on. Even though the SSRIs have finally gotten a black box warning for people up to age 24, it has not stopped them from causing akathesia resulting in multiple homicide events, suicide, birth defects, and ad infinitum. Recent clinical trials say that these drugs are not better than placebo but yet they cause terrible psychiatric and medical harm. There is a bill passed by the House and waiting to come into the Senate, S 3175, backed by a number of Pharma front organizations, that will push these drugs for women with “postpartum depression”. Check the bill out on Thomas. Gotta make a buck.
Nathan
Anne,
Thanks — that’s the full disclosure I’m talking about.
1) It’s not is a bad thing to have had one’s son killed by Lilly’s Zyprexa, etc. But it is very relevant. Just as relevant as the fact that I am employed by the pharma industry.
2) Again, it is NOT a bad thing that you are a board member of an organization that battles against false clinical trials, ghost/drug company-written journal articles, etc. However, it IS very relevant. Just as relevant as the fact that I am devoted to the development of alzhiemers medications due to the fact that my grandfather died from the disease.
3) It is not a bad thing to have dear friends whose children committed suicide on SSRIs or died of profound hyperglycemia or pancreatitis from Zyprexa. But it is relevant to understanding which part of your posts may be influenced by emotion rather than logic.
You (pg, and others) claim that my posts are motivated by personal (financial) interest. Fine. Everyone posting on this site has a vested interest in this industry. Otherwise we wouldn’t bother posting. You should get over the illusion that only us people in the pharma industry have an angle we are spinning.
Nathan
Jane says: “Interesting how you have taken a psychotropic class medication to try and discredit pg. Why not ask if she/he has ever suffered a negative effect to any medication?”
Good point, my appologies. If you’ve followed this site for a while, you’ll know that pg has a keen interest in antipsychotic medications. That’s why I asked about SSRIs.
pg
“If you’ve followed this site for a while, you’ll know that pg has a keen interest in antipsychotic medications. That’s why I asked about SSRIs.”
SSRIs are not antipsychotics.
pg
Perhaps you’d be interested in this Nathan. Although not involving a pharmaceutical product, there are a number of studies implicating diet in prevention of alzheimers, but this one is regarding diet and and an improvement in Alzheimers and, in case you’re wondering, I don’t have any affilition with health food companies…
http://www.telegraph.co.uk/news/uknews/1562765/Mediterranean-diet-‘helps-Alzheimer’s-sufferers’.html
pg
The link doesn’t hold together. Just copy the whole line into the browser and it will.
pg
Nathan I have a wide range of interest in drug products, the way they are developed, the spin that surrounds a great number of them and the side effects that follow.
For instance, there are problems involving the vaccination for bird flu. At the same time, promising research such as the following are generally ‘unnoticed’ by mainstream media, hence the need to also look for these studies in any area - even health food sites:
http://www.nutraingredients.com/news/ng.asp?n=65394-razei-bar-sambucol-bird-flu
Black elderberry extract may reduce flu symptoms
26/01/2006 - Sambucol, a standardized extract of black elderberry, has been found to fight the avian flu virus H5N1, revealed British researchers last week.
A team at Retroscreen Virology, an institute associated with the University of London, said that the extract was at least 99 per cent effective against the H5N1 virus and significantly neutralized the infectivity of the virus in cell cultures…”
pg
Psychotropic drugs however such as antipsychotics, antidepressants and stimulants with all the same spin, non-disclosure, manipulation of data, stifling of scientific processes, etc, are those that are regularly and ever increasingly prescribed to many millions of people, including vulnerable children and the elderly, and therefore more focus tends to be on those drugs.
In addition, the doctors that are normally associated with publications regarding psychotropics - psychiatrists - are also the ones who earn the most money from Big Pharma.
http://www.nytimes.com/2007/06/27/health/psychology/27doctors.html
“As states begin to require that drug companies disclose their payments to doctors for lectures and other services, a pattern has emerged: psychiatrists earn more money from drug makers than doctors in any other specialty.
How this money may be influencing psychiatrists and other doctors has become one of the most contentious issues in health care. For instance, the more psychiatrists have earned from drug makers, the more they have prescribed a new class of powerful medicines known as atypical antipsychotics to children, for whom the drugs are especially risky and mostly unapproved…”
pg
As you have a personal interest in Alzheimers and in case you are not already aware of it, antipsychotics may also be especially risky for those with alzheimers and dementia:
http://news.bbc.co.uk/1/hi/health/7366416.stm
MPs urge cut in dementia drug use
MPs have urged the government to stop the “dangerous over-prescribing” of antipsychotic drugs to people in care homes with dementia.
The All Party Parliamentary Group on Dementia said the drugs should only be used as a last resort.
Research published earlier this month said the drugs had no benefits, and could even worsen patients’ condition…”
http://www.nhs.uk/news/2008/04April/Pages/AntipsychoticsandAlzheimers.aspx
“Antipsychotics and Alzheimer’s
“Medication ‘worsens Alzheimer’s’” reads the headline on the BBC News website today. The BBC reports that a study in 165 people with Alzheimer’s has found that antipsychotics “offered no long-term benefit for most patients with mild symptoms of disturbed behaviour”. It says that about 60% of people with Alzheimer’s in nursing homes are given antipsychotics to control problem behaviours, such as aggression. The Guardian also reports on the study, saying that these types of drugs (neuroleptics) have severe side effects, including stroke and death…”
http://www.bloomberg.com/apps/news?sid=aTJnSxKPZ0To&pid=20601082
“Antipsychotic Drugs Triple Risk of Death for Dementia Patients
May 26 (Bloomberg) — People with dementia more than tripled their risk of death or hospitalization within a month of taking antipsychotic drugs to silence their agitation, according to a study.
Those taking a class of antipsychotic drugs including generics haloperidol and loxapine were 3.8 times more likely to be hospitalized or die, according to research published today in the Archives of Internal Medicine. People taking newer medicines including Eli Lilly & Co.’s Zyprexa and Johnson & Johnson’s Risperdal had 3.2 times more risk of complications or death.
Antipsychotic drugs, often prescribed as a short-term treatment for dementia’s confusion and rages, have been associated with falls, hip fractures, strokes and death in other scientific studies. The new research collects the potential for death and all other serious risks together for the first time…”
The situation regarding unnecessary and injurious drugging of millions is out of control. The world desperately needs people like Sen Grassley to help try to bring it back.
Talbot
The job of FDA is to ensure that drugs do what they say they will and clarify safety risks. Problems arise when an endpoint is used to assume a clinical outcome. This becomes even more muddled when the clinical outcomes are based on epidemiologic, association-based (rather than cause and effect) data. “Lower lipids to combat cardiovascular disease” is a good example. People with diabetes try to get their blood sugar under control to reduce their risk for negative outcomes such as heart disease. A drug that lowers blood sugar but increases the risk of heart disease is an clinically irrelevant drug for these patients. And for a patient undergoing cancer treatment to live longer, a drug that doesn’t achieve this may also be clinically irrelevant.
pg
That explains a bit more, Talbot, to a non-scientist like me, why Sen. Grassley wants FDA follow-up studies on end point approvals. Thanks :) I’m not sure what is meant by ’surrogate’ (end points)?
HorusCat
Nathan,
Is your dad still at home? If not, I hope he is in a good LTC facility. Despite what pg et al say, pharma is not selling antipsychotics to geriatricians. The biggest culprit in that prescribing is often the staff–they like the patients sedated and quiet, and the docs go along.
The newer APs do have a higher mortality rate than Haldol, no one is sure why. It appears that intimacy (not sex, but you know, platonic touch, etc) and attention can calm many of the self-injurious and frustrating behaviors of AD. I will keep your dad in my prayers.
HC
Nathan
HC,
Thanks for your concern, but it was my grandfather who had AD. (about 3 years ago) My dad is perfectly healthy for the moment.
There are lots of promising treatments coming through the pipeline right now for AD. (phase I, II, and III) I’m obviously interested in AD from a personal perspective, but I’m also interested in it from a buisness perspective: From estimates I’ve seen, a truely effective drug could generate $10-$50 billion per year. My company has made AD the centerpiece’s of it’s research program in recent years. In a perverse way, the fact that there are still several “untreatable” diseases out there gives me some modest hope that the pharma industry can pull itself out of the doldrums we’ve been in for the past decade. (Alzhiemer’s, Multiple Sclerosis, Huntington’s, cancer, IBD, Crone’s disease — all these are active areas of research at most major companies currently)
Nathan
I should clarify - he died of AD about 3 years ago. He was diagnosed about 10 years ago. As more and more people are aware, it’s a horrible disease to watch. Fortunately, the patient seems largely unaware of what they are going through during the later portions of the disease. However, the burden on caregivers (my dad in this case) is absolutely tremendous.
HorusCat
Nathan,
Sorry–I should have reread before posting. Yes, AD is most horrific for the caregivers. My husband’s mom is quite demented now; he isn’t caring for her, but it is tearing him up to see her that way. His dad is a trooper. There is very promising research being done in the AD area–in the meantime, work crossword puzzles and eat your blueberries!