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

Justice in Michigan wrote on pharmalot.com on Oct 20, 2008

Wyeth may not have been deliberately misleading in their labeling of Phenergan, but they are certainly misleading in their release about the Levine case. I am very glad they are going public, however. Their arguments dissolve like the mist.

For starters:

- How and whether FDA reviewed IV push, and whether “careful consideration” was given to the phenergan label, is a matter of debate. FDA itself has yet to document a review process anything like what Wyeth suggests. See Catherine Sharkey on this.

- As we all know from CBE discussions, Wyeth certainly _could_ have unilaterally changed the warnings had they been inclined to do so. The so-called “violation of federal law” is all smoke. If FDA disagreed with any such change, the label would have been changed back. End of story.

- Preemption of the sort being sought currently _is_ entirely new for FDA. Appeals to the Supremacy Clause are more distraction from that reality, which FDA itself acknowledges.

- The ‘chaos theory’ of multiple standards has always been airy fairy. As has been noted, for example, when Medicaid in Washington and Oregon opted in 2002 not to include Vioxx because of safety/effecacy, no one in Idaho got confused. We have lived very well for yours with civil liability and FDA regulation as complementary systems, just as we have complementary and parallel state and federal requirements in many areas. Unless the preemptors are ready to abolish the states entirely, there is no substance to this argument.

- The final paragraph of Wyeth’s release shows lawyerly shenanigans at their most obvious. It is one non sequitur after the other, all deliberately aimed to suggest what Wyeth knows is not true. Core issue - the vast number of cases in which companies committed everything from negligence to felony fraud could be preempted as a result of Levine. Wyeth tries to side-step this by suggested there are only cases like Levine and those that involve “manufacturing defects.” The very way this is phrased reveals that Wyeth, like preemptors in general, want preemption to be upheld as broadly as possible - including all failure-to-warn cases even when negligence/fraud are involved.

Answering Wyeth wrote on pharmalot.com on Oct 20, 2008

They [i.e. Wyeth] begin:

Preemption Protects Everyone

– The fact is this is simply unsubstantiated and unsupported in the arguments below.–

Wyeth: The Constitutional principle of preemption is not new. Preemption arises from the U.S. Constitution, which under the Supremacy Clause invalidates all state laws that conflict or interfere with federal law.

–The Supremacy Clause was meant for issues such as declaration of war or treaties that might be initiated by States, not in reference to public safety unless specifically stated by law initiated by Congress. Law initiated by any branch of government other than the Congress should be suspect from the start. This is the circuitous route preemption has taken.

The laws of the land, as with any governing rules, should not contradict themselves. Preemption itself causes such contradiction with the Federal Constitution. On the one hand, our Constitution states that the citizens shall have the right to be heard in a court of law when its citizens feel they have been harmed. Preemption repeals that right by absolving certain corporations from challenge in a court of law. Furthermore States are given the responsibility, by the Federal Constitution, for the safety of its citizens. State law is one means to accomplish that. Again preemption causes conflict with this mandate. It seems that preemption causes more conflict than it remedies. Unfortunately the harm that the conflict causes is taken from the corporation and thrust upon the backs of the public.–

Wyeth: In Wyeth v. Levine, the Vermont’s jury verdict was in direct conflict with the FDA’s considered scientific judgment.

–This brings into question the judgment of the FDA. Two points can be made here.

1. What is the capability of the FDA’s judgment?

The FDA itself admits that its capability is such that the American public is in danger.

2. Who is the FDA is judging for. If the FDA is judging for the public, that’s fine. Is this the case? In these times, sadly this point is being debated. Does the FDA cater more to the corporation or the American citizen? The fact that there even IS a debate about this should cause one to shudder. If there is any doubt about who the FDA serves, preemption should be shelved until such time as this issue is unquestionably resolved.–

Wyeth: Patients and physicians need to be able to rely on a single federal standard and guidelines for the risks, benefits, and use of medicines — the FDA-approved labeling.

– What patients need is a sense of confidence in their drugs, devices and doctors. The current clear lack of confidence (which is getting worse by the day) warrants an increase in protection not a decrease in recourse from harm. Preemption is calling for the public to lay down the one means of personal protection that they can grasp with their own two hands (If they still have them) and put total trust in the Pharmaceuticals companies and the FDA, both shown to be untrustworthy. –

Wyeth: 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.

– Please provide evidence of this.–

Wyeth: Such a system would undermine the careful balance struck by the FDA when making approval decisions.

– This so called “careful balance” would suffer a seismic shift from the public that consumes the product in favor of the manufacturer that produces the product. This careful balance of safety would be destroyed. Again please provide the evidence that the current system is out of “balance”? How has the past 70 year of no preemption caused such harm?–

Wyeth: Upholding preemption will still leave America’s courthouse doors open to injured patients. The only claims that will be decided are those where the jury’s verdict conflicts with the FDA’s considered scientific judgment.

–See above comments about considered judgment.–

Wyeth: Any consumer who is injured as a result of a manufacturing defect may still seek redress in court and manufacturers will remain subject to strict FDA-imposed penalties for concealing information from the FDA.

–Maybe you can fool some of the people some of the time… this statement reeks of duplicity.

The evidence is – Some Pharmaceutical companies (probably more than we know about) habitually conceal information from the public and from the FDA. How would you propose that we find out about that aside for the state torte? No, preemption slams the courthouse door, locks it and throws away the keys that have for so long been the property of the American citizen.–

Doug Bremner wrote on Oct 20 2008

A reader points out a post on internetdrugnews.com written by Corey Nahman the following post [just to show you we allow all viewpoints to be heard]

10/20 Preemption: Wyeth Goes Public With Its Side Of The Story

Wyeth v. Levine: Preemption and The Facts … improperly administered by a physician assistant at a dose twice the labeled maximum for IV use, and clear indicators of an improper administration were ignored … verdict was in direct conflict with the FDA's considered scientific judgment …[Wyeth Press Release]

Editor's Note: Wyeth claims it is being unfairly screwed (and it is) because the P.A. that administered the medicine (Phenergan) blatantly didn't read the directions and should be blamed, not Wyeth.

Editorial Comment: It' would be the same thing if someone gets into a car, drives it 100 mph into a tree and dies and blames Ford for the accident because Ford never warned people that driving 100 mph into a tree is very dangerous and may cause injury or death. We predict that Wyeth will be vindicated.

Doug Bremner wrote on Oct 20 2008

Although I do not agree with preemption, as written about by Ed Silverman, here and

here and

here , my understanding is that many legal eagles (I am not a lawyer) question whether this is the best case to settle this important issue.

Editorial Note: October 21, 2008, "Justice in Michigan" pointed out on pharmalot.com that the Supreme Court is going to rule on preemption as a doctrine, not on the specific merits of the case in Levine v Wyeth, so arguments about the proper use of phenergan are not relevant here, or so I understand, although I am no legal eagle.

Justice in Michigan wrote on pharmalot.com on Oct 21, 2008

What the Supreme Court will decide is not the merits of the Levine case (unless they remand it back to Vermont) but the merits of preemption as a doctrine. That is what the Court decided to hear, and what Wyeth and its allies wanted them to hear.

Based on off-board communications, the following needs clarification. It is a good lesson for those who have a congenital distrust for lawyer-speak. That is, it will confirm your prejudice.

Wyeth concludes its statement with the assertion: “Upholding preemption will still leave America’s courthouse doors open to injured patients. The only claims that will be decided are those where the jury’s verdict conflcits with the FDA’s considered scientific judgment. Any consumer who is injured as a result of a manufacturing defects may still seek redress in court and manufacturers will remain subject to strict FDA-imposed penalties for concealing information from the FDA.”

Here are four non sequiturs in a row. It is certainly “crafty,” to put the best face on it.

Initially, it is written to _sound_ like a Catherine Sharkey position. FDA will have to demonstrate “considered scientific judgement” on the risk in question. That could lend itself to very narrow preemption if FDA was compelled to demonstrate its assessment process, as in Sharkey’s model. But that is not the argument here. “Considered scientific judgment” - in this statement - means anything the FDA has decided re: labeling preempts all civil claims. Period. End of story.

The “manfacturing defect” is an old canard in preemption speak. It rarely applies in the drug arena; more often in devices, but is extremely difficult to prove. So the courthourse door that is supposedly “left open” by it remains, in fact, bolted if not barred.

The reference to “strict FDA imposed penalties for concealing information’ has been exposed many times here for the farce that it is.” Such penalties are very rare, and even more rarely strict. What we’re talking about are occasional warning letters, remedial plans, occasional small fines (in the scheme of things), and in very rare cases larger fines and a misdemeanor charge. So much for policing fraud.

As I said up thread, Wyeth may have been honest about phenergan. It is not being honest about this case.

Doug Bremner wrote, the discussion is ongoing on pharmalot.com on Oct 20, 2008 and readers can follow it there, I did not post all the comments on this site.

George wrote on Oct 21, 2008

The reason there are advisory boards made up of consultants is because those are the researchers & clinicians that are getting involved so to speak. Unlike arrogant ivory tower asses like Dr Bremner who see fit to judge others when he does nothing to driv...

Doug Bremner wrote On October 21, 2008

I warned you guys that comments get cut off after two sentences and George can email me if he has more comments, but I get the gist of his comments. I might point out that pharma is involved in shaping who becomes KOLs, sure that can't make silk from a sow's ear, but given the choice between two equals they will reward the one most favorable to them. It is my opinion that consulting and speaking payments can influence opinions, even if slightly. But hey, my opinion doesn't matter that much, the public opinion is pretty uniformly negative, and that is what counts.