OCTOBER 21, 2008
What Me Worry? The FDA Will Protect Me from Toxic Drugs (NOT!)
Tomorrow's issue of JAMA has the results of an interesting
study by T.J. Giezen et al that examined 174 prescription medications (136 in the US,
the rest in Europe, and 67 approved in both places), as well as some letters on preemption
and an editorial that discusses these related topics. In the study of Giezen et al, 24% of the drugs had a
regulatory action after approval by the FDA or a European regulatory agency,
including 19 black box warnings, and 47 dear doctor letters. The probability of having
regulatory action in the ten years after approval was 29%. Drugs that were the first of their
kind ("first in class") had a four fold higher risk of safety regulatory action
than drugs that came on the market later.
Would you play Russian roulette with a four chamber gun and a single bullet in the
gun? I wouldn't. That is why the looming probability that preemption
of tort litigation, which translates into English
as citizens giving up their right to have a day in court for toxicity or death related to FDA prescription
drugs, will become the law of the land, is particularly chilling. You see, the study by Giezen et al showed that one in four drugs
are found to have a dangerous side effects, like cancer, or impairment of the immune system
that can lead to life threatening infections after they have been on the market and approved
by the FDA that wasn't known about before they were approved by the FDA.
It just isn't possible to know all of the possible side effects of medications with the small numbers
of subjects that are included in studies leading up to the FDA approval process. The FDA itself admits that.
Which gets me to another topic that I have been harping about lately,
preemption, and
the case of Levine v Wyeth, which would take away the rights of citizens to have their day in
court for damage caused to them by FDA approved prescription drugs.
(See
"No Redemption for Preemption" and
"Some of Us Doctors Actually Care About Our Patients".
In a pair of letters,
Piwinski and Fitpatrick initially assert that the case of Riegel v Medtronic Inc., in which the Supreme Court
ruled that for medical devices that approval by the FDA preempted state law and eliminated the rights
of citizens to have a day in court, was a good thing, that we shouldn't have juries and the right to trial
[causing Jefferson and Madison to toss in their graves, surely]
and that [in that particular case] the problem
was not that Medtronic made a lousy angioplasty device that exploded in the coronary artery
of the injured party, but that the guy had led a life of licence or had a star crossed
destiny that led to his demise.
Gostin replied that juries do not evaluate medical devices, they listen to medical experts,
and that we shouldn't be ready to toss the constition just yet.
In an
editorial on these letters and the study of Giezen et al,
DeAngelis and Fontanaros cite the Institute of Medicine and FDA blue ribbon commission reports that noted
that the FDA was woefully inadequate to protect us from toxic side effects, and was putting Americans at risk.
They said that post approval the drugs are used in populations that are less carefully selected than participants
in clinical trials. [translation: the clinical trials pick squeaky clean participants that are least
likely to have a bad reaction, viz Chantix for stop smoking trial excluded patients with mental disorders,
who make up one fourth of the population and are twice as likely to smoke.
They then cut loose the drug on the population and were surprised when people started freaking out on the drug].
See
"Time To Die! (Oops) I Mean Time to Quit!"
DeAngelis and Fontanaros later write:
Tortlaw serves in effect as a way to close regulatory gaps
in the FDA premarketing approval process and to provide a
mechanism for postmarketing surveillance. Moreover, litigation
has been a rich source of information about how drug and device
manufacturing companies behave, such as with off-label promotion,
guest and ghost authorship, and reporting of safety findings.
Without the information revealed by the public release
of documents in tort liability actions, many of these behaviors
would remain unknown, some drug manufacturers judgments
about safety issues would be hidden from view, review, or oversight,
and the FDA would not be able to uncover them either.
In other words, law suits are the only way to keep the bastards honest.
Catherine DeAngelis is probably still pissed off about the
CLASS study of Celebrex that was published in JAMA when she was the editor, in which the authors
withheld data from the second six months of the study during which time Celebrex
patients were shown to have an increase in heart attacks.
That, my friends, is fraudulent.
But it isn't clear that it would get snagged if preemption became the law of the land.
They further state that:
...drug manufacturers
have the authority and responsibility to modify labeling
when hazards manifest and may do so without
securing prior approval from the FDA...
The human body is in a constant state of change and the effects of some drugs
will manifest only after exposure over time. Furthermore, some
serious adverse drug effects are quite uncommon and require
use of the drug in large numbers of patients to become evident.
The safety of drugs in a clinical trial, the study type used for FDA
approval, is based on specific participant types, numbers, and
design that cannot ensure the true safety of a drug. In addition,
manipulation of study results by the drug manufacturers (who
almost always sponsor studies used for decisions about drug
approval) can obscure the true safety profile of a drug...
Therefore, unless and until the FDA drug approval process
and the postmarketing surveillance system improve significantly,
patients must have a means to seek recourse through
tort litigation against product manufacturers. Anything less
may well preempt the well-being and safety of the public.
In other words, the argument that the FDA alone decides what is a risky side effect, and that drug makers
can't do anything without FDA approval, is poppycock.
I couldn't agree more.
Pay attention guys. This isn't just some bozo talking. This is from someone who has served
as the editor of JAMA, one of the leading journals in the medical field.
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COMMENTS
hg from www.pharmaccountability.org wrote on October 21, 2008
Key bit in your blog, Doug. The infamous half-ClASSED study that JAMA published - while fraudulent - was entirely _outside_ the purview of FDA jurisdiction (they dont regulate medical journals). So this is a perfect example, among others, of why
[preemption is not a good idea].
Doug Bremner wrote on October 21, 2008
Agreed. Also please note that the Bush administration has been a key promoter of preemption (Thanks pharma!)
Matthew Holford wrote on October 22, 2008
Doug,
Is it worth pointing out that the regulator in the UK (if nowhere else), seems happy to take the word of the manufacturer,
when it comes to licensing? In other words, as far as I can establish (ie, as far as the MHRA will let me establish -
and its stonewalling antics have been backed up by it parent government department, and the UK information watchdog,
the Information Commissioner's Office), there is no valid assessment system.
If, several years down the line, we find that drugs licensed in this way have chilling side effects, then, frankly,
it should not be a surprise to anybody. More fool us for continuing to play the game.
Matt
Tom Lamb wrote on October 22, 2008
To help "educate" people about this all-important legal and public policy issue, I have recently put online a resources page called
"Federal Preemption of Drug Injury Lawsuits" which can be accessed
Here.
On that page I have included your recent article, Some of Us Doctors Actually Care About Our Patients.
Keep up the good work.
Tom Lamb
OCTOBER 20, 2008
Some of Us Doctors Actually CARE About Our Patients!
The drug maker Wyeth has issued a
press release
on the topic of
preemption, as related to the case before the Supreme Court of Levine v. Wyeth.
Simply put, preemption strips away the rights of consumers to have redress in court
if they have a toxic or fatal side effect from an FDA approved prescription medication.
The
good people of Michigan have been struggling with this law for a decade,
and now the drug companies are trying to push it through to become the law of the land.
Here is their press release.
The public health is better served by having a single expert regulatory body making decisions
about risks, benefits, and warnings - rather than an ad hoc system that could produce hundreds of
conflicting results that would be impossible for manufacturers, physicians, and patients to reconcile
or interpret. Such a system would undermine the careful balance struck by the FDA when making approval
decisions. If Wyeth prevails here, it will only reinforce the principle
that doctors are entitled to rely on FDA-approved professional labeling.
Ha ha ha ha ha ha ha!
These are just a FEW of the reasons I think this argument is ludicrous.
How can you say that their viewpoints are carefully balanced, when they are
guided by advisory panels of physician "key opinion leaders" that are usually on their
payrolls as consultants, speakers, and/or advisory board members? And the
fact that this advice is skewed can be shown by numerous examples, e.g.
the fact that "expert guidelines" recommend the use of statins for the
prevention of heart disease in women, when the evidence in the literature
clearly shows that there is no benefit, only the risk of harm in the
way of side effects? Preemption would effectively yank the protection that Americans get
from the judicial branch of government and leave the executive
and legislative branches in charge of protecting them. And what
do they know about drug safety? Since the FDA's leadership is politically appointed,
this would put the responsibility for guarding Americans in the hands
of a small group of politicians who frequently benefit from donations from
pharmaceutical companies. Witness how Dan Troy went from representing
pharma to a job as chief counsel at the FDA, where he filed friends of the court
briefs on behalf of FDA on the side of pharmaceutical companies whose
medications had caused serious injury or death, on the rationale that since
the FDA had approved the medications that they had a stake in the outcome.
After this little jaunt he then tripped back to a cushy job in pharma.
Or here is another example. George Bush thought was so concerned
about protecting us from dangerous prescription medications, that he
appointed a veterinarian, Lester Crawford, to run our nation's drug regulatory body, the
FDA. I'm not sure if I feel comfortable having an expert on cows
deciding which drugs end up in my medicine cabinet. Thankfully,
Lester was so stupid that he didn't disclose or divest of the stocks he owned
in the pharmaceutical industry, and precipitously had to resign.
Lately we have had to watch senators shouting at the FDA to tell
him how much money they needed to keep America safe from Chinese
milk or pet food or the latest drug disaster. The Director couldn't
tell him, or more likely wouldn't, since his marching orders were to
keep the budget small.
With the
Prescription Drug User Fee Act" (PDUFA) resulting in pharmaceutical companies paying
more and more of the budget of the FDA, with PDUFA mandating that less goes to drug surveillance
(watching drugs already FDA approved),
the FDA is essentially working for them, so
sure pharma thinks it will be a good idea to have a "single regulatory body",
especially if it is working for them. And
outside reviews of the FDA
have said they are putting Americans at risk through their shoddy
regulation of prescription medications.
Another argument against preemption is that taking the issue out of
the courts removes a potential way to uncover fraud and deception
in the management of data related to clinical trials, something
that has come up not just once, but repeatedly, through the
discovery process of ongoing trials.
And what is the argument about the law being "impossible to interpret."
I have a suggestion for you, if a prescription medication is found to
have an adverse outcome, warn doctors and the public, and if is too
dangerous, take it off the market. That is what you are paying your
doctors and scientists to do, analyze your data and evaluate
risk/benefit ratios.
How about
...reinforce the principle that doctors are entitled to rely on FDA-approved professional labeling.
Let me translate that one for you:
Physicians, support this proposed ruling, because then you
won't have to worry about covering your asses for prescription medication disasters.
I've got a thought for you, Wyeth. Maybe some of us physicians actually CARE about whether we are doing
harm or good for our pateints.
Whadya think about that?
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Comments
Dr. Jeffrey McCombs wrote on
the Huffington Post on October 22, 2008
Great article!
The FDA is underfunded and willing to take Big Pharma money in order to stay in business. Unfortunately, this makes Big Pharma the local heroin dealer of sorts, and the FDA is willing to do most anything to get its fix. This is another example of government privatization that works against the best interest of Americans.
MDs are learning more and more that drug company reps can't be trusted with the information that they provide, as it tends to be incomplete and biased. I don't think any MD went to school to be a middleman for the pharma industry, but many times it seems that way to patients when all they get are more prescriptions for more drugs.
"The doctor of the future will give no medicine..." Thomas Edison
goodneighbor420 wrote on
the Huffington Post on October 22, 2008
Good Post! Wow, it is about time doctors started speaking out about this ludicrous attitude. When I read
the long long lists of side effects for pharmaceuticals it makes me wonder which is worse, the disease or the
'cure'. As for me, if there is any other suggested help for a medical problem that I might have besides
pills--change of diet, etc--that's what I'll try first.
Doug Bremner wrote on Oct 22 2008
btw Henry Greenspan - Justice in Michigan - pointed out today that the Supreme Court is specifically going to rule on preemption - not the merits of the specific case.
Corey Nahman of internetdrugnews.com wrote on Oct 22 2008
Doug -- hate 2 say this but the Supremes are politically polarized; i would be surprised if they strike it down.
As with the legal marijuana issue, this court does not like to let states grab power back from the Feds. If I am right, the majority opinion will use the possibility of zillions of lawsuits as the reason it wants the FDA to have final say.
They fear activist state governments building a patchwork of liability standards; each state would need its own quasi FDA.
They would rather drink gasoline than admit that FDA is even a teeny bit biased.
Corey
