Pfizer fined $430M in Neurontin case

[rdf]

"No. 1 drugmaker pleads guilty for pushing epilepsy drug for other, unapproved uses.
May 13, 2004: 3:45 PM EDT"

"WASHINGTON (Reuters) - Pfizer Inc. agreed to pay $430 million and plead guilty to criminal charges for illegally marketing an epilepsy drug for unapproved uses such as migraines and pain, U.S. prosecutors said Thursday."


pfizer story (http://money.cnn.com/2004/05/13/news/fortune500/pfizer.reut/index.htm)

-peace http://sci.rutgers.edu/forum/images/smilies/smile.gif

[Snowman]

Hopefully, patients will see some of this money..........

http://sci.rutgers.edu/forum/images/smilies/smile.gif http://sci.rutgers.edu/forum/images/smilies/cool.gif http://sci.rutgers.edu/forum/images/smilies/smile.gif

Eric Harness,CSCS
Project Walk™ (http://www.projectwalk.org)

[bigbob]

From the same article I couldn't believe that stuff like this happens-"Franklin accused Warner-Lambert of hiring an outside firm to write at least 20 articles for medical journals that extolled unauthorized uses of Neurontin and then paid doctors for use of their names as authors of the reports, according to court documents."

It's a greed driven world.

........You need people like me so you can point your
fxxxing fingers, and say "that's the bad guy." So, what dat make you? Good? You're not good; you just know how to hide......... Scarface

[bigbob]

Make that drug company do community service and fund wheelchair sports at Rutgers, and those Doctors should have to volunteer to a disability center at a university(but would you want to be treated by them?)

........You need people like me so you can point your
fxxxing fingers, and say "that's the bad guy." So, what dat make you? Good? You're not good; you just know how to hide......... Scarface

[bigbob]

Is this "Westie" science?

........You need people like me so you can point your
fxxxing fingers, and say "that's the bad guy." So, what dat make you? Good? You're not good; you just know how to hide......... Scarface

[Wise Young]

I was hoping that some other people would commment on this topic.

In my opinion, this is an unfortunate develoment for three reasons.

1. This will discourage off-label use of drugs. Although neurontin has not yet been approved by the FDA for neuropathic pain, over 100 scientific articles have been published showing that it is beneficial in animal models of neuropathic pain and about 20 clinical trial have reported that it is useful for reducing a variety of neuropathic pain. Many people on this site have reported that it is useful for their pain. The FDA is clearly cracking down on companies that are encouraging doctors to use drugs of non-approved indications.

2. It will result in the denial of neurontin (gabapentin) for many people who have neuropathic pain and are currently benefitting from the drug.

3. Given the substantial evidence for neurontin safety and the information that suggests that this may be effective for neuropathic pain, a condition for which there are no effective therapy, it is truly unfortunate that the lawyers involved chose this particular drug to make the case.

Have you wondered where most of the $430 million will go? A big chunk will go to the lawyers.

Wise.

[QuadPro]

I hope they dont discontinue my neurontin cause everytime I try to lower my dosage the pain is just unbaerable, I cant imagine it completely taken away. I hope they give me someting for the pain because well I just cant and dont want to imagine the pain.

[jpw]

I can not resist replying to the off the cuff lawyer bashing below...

"Have you wondered where most of the $430 million will go? A big chunk will go to the lawyers."

This was a criminal prosecution, albeit with its origins in a whistle blower complaint. A criminal prosecution is worlds different than the tort lawsuits that terrify doctors and drive tort reform (regardless of whether you agree with tort reform or not). The government is the entity that chose to pursue this company and their actions regarding this drug.

The article ends with a listing of where the money will go.

"The U.S. Attorney's Office in Boston, which spearheaded prosecution of the case, will receive $240 million of the settlement for criminal violations of the Food, Drug and Cosmetics Act.

Franklin will receive about $24.6 million.

Another $152 million will be distributed to the states and federal government for Medicaid violations. Other sums will be distributed to state health agencies and departments, while $28 million will be used for a national advertising campaign and remediation program to be overseen by state attorneys general."

JP

[Wise Young]

jpw,

I did not mean to bash lawyers but over half of the amount went to the U.S. Attorney's office in Boston, presumably to cover the costs of the legal prosecution of the case.

By the way, methylprednisolone has not yet been approved by the FDA for use in spinal cord injury.

Wise.

[metronycguy]

Originally posted by Wise Young:

I was hoping that some other people would commment on this topic.

In my opinion, this is an unfortunate develoment for three reasons.

1. This will discourage off-label use of drugs. Although neurontin has not yet been approved by the FDA for neuropathic pain, over 100 scientific articles have been published showing that it is beneficial in animal models of neuropathic pain and about 20 clinical trial have reported that it is useful for reducing a variety of neuropathic pain. Many people on this site have reported that it is useful for their pain. The FDA is clearly cracking down on companies that are encouraging doctors to use drugs of non-approved indications.

2. It will result in the denial of neurontin (gabapentin) for many people who have neuropathic pain and are currently benefitting from the drug.

3. Given the substantial evidence for neurontin safety and the information that suggests that this may be effective for neuropathic pain, a condition for which there are no effective therapy, it is truly unfortunate that the lawyers involved chose this particular drug to make the case.

Wise.

this is not good for pain sufferers . neurontin saved my butt for the first 2 years as a off label use. especially dealing with workers comp who needs to approve everything , at least with neurontin if you find/think the pain is less you can wean yourself off pretty easily , without having to deal with physical dependency issues common with the others. i hate to think what other drugs i would have had to take to qwell the neuropathic pain in those first 24 months.

[Broknwing]

Obviously, it's illegal for them to promote it for uses other than what it has been approved for, but if they hadn't would those of us that successfuly use it for neuropathic pain be fortunate enough to have discovered it's benefits? Just because it's not "FDA Approved" for a specific use, doesn't mean that it doesn't work for it. As Dr. Young said, methylprednisone is not "approved" for sci's, but how much worse off would some of us been, if we had not been given it in our trauma care? Drug testing for FDA approval is a very long & expensive process, if we can get relief we need, then I think that as much as it is illegal to promote the drug for a certain use, it is not illegal for our dr's to prescribe it as such.

'Chelle

[mike]

Although it is disappointing to see this kind of problem occur, I do wonder in Pfizer did apply to the FDA for use of this drug for the relief of neuropathic pain. This drug has been used for relief of pain for many years so it is hard to see with the evidence demonstrating it's effectiveness why Pfizer would not have gotten permission to recommend it. Could it be that Pfizer did not want FDA approval, because as part of the approval Pfizer would have to list some of the side effects such as edema, weight gain and problems with memory.

Also I have not seen where there has been FDA approval on all of the other antiseizure drugs and antidepressants which today are the only treatments available for central pain. Does this mean we should all suffer in silence while the FDA gets their act together?

mike

[dejerine]

"If you fire into a flock of geese, the bird that flutters is the bird that has been hit." The legal process reeks. It is too expensive. The former Supreme Court justice who said his greatest fear was that he would become involved in a lawsuit knew what he was talking about.

I comment here mainly because of the prior discussion about the costs of making a Worker's Comp claim when the original idea was to make things very simple to avoid litigation. The US attorney in Boston could have done more good for the public than to send out a message to any drug company thinking about a drug for neuropathic pain that this path was hazardous financially.

The place to start is the COSTS of litigation, the award to the Boston lawyers illustrating this point.

We should facilitate the prosecution of litigation by bringing costs down immediately, way down. What was hard about the Pfizer case that was worth a quarter of a billion dollars? They didn't get FDA approval and they promoted the drug for something vague, called neuropathic pain, after doctors started using it that way bigtime.

Compare this with the suit Upjohn won about Rogaine. Upjohn got way more than they initially expected. Doctors were using it like mad for hair loss although it was a blood pressure drug. The courts ruled that although Upjohn had no FDA approval for hair loss, they still had impliedly cleared it for hairloss, so they rewarded Upjohn a new patent disallowing generic Rogaine. So we got many years of high priced Rogaine, as if Upjohn HAD rights to it when they got it FDA approved for blood pressure.

Was Dr. Young "lawyer bashing"? No. Lawyer "bashing" would require blanket or global denigration. Commentary about one specific action, where the AMOUNT of the lawyer fees were simply mentioned in passing would not be bashing. The expense of litigation must be kept down or justice is impossible. Public policy should have prevented the decision. Pfizer was mirroring the amorphous way antiepileptics have been applied to nerve injury pain. No one has shown that abnormal discharges are not behind neuropathic pain.

No aspect of our governmental behavior is beyond comment. The price of justice is currently well beyond the average man's ability to obtain it. Ours is probably the best way yet invented, but the legal system is long overdue for reform, particularly in the way expert witnesses are employed, the obscene costs of court reporting (despite perfectly good and cheap voice recognition software which most lawyers would prefer for its cost), the election of judges in Louisiana and elsewhere, the willingness of municipal judges to rubber stamp the police, and the poor salaries for juries, who are often less educated than the general public.

Thomas Jefferson said he feared the aristocracy of the judiciary as much as the aristocracy of lineage. He made "trial by jury" the hallmark of justice, but today we have reverted to trial by judges, who may not resist the idea that if they hope to ascend the legal ladder to the federal courts, they had better issue rulings that are inoffensive to political parties.

Trendy rulings too often reflect political agendas. This means doctors who prescribe pain meds will not be protected, and it means Pfizer is an easy target for allowing Neurontin to be used almost exclusively for nerve injury pain, when it was billed as an antiepileptic. Still it was a bogus legal attack. Now, drug companies will be in no hurry to develop drugs for neuropathic pain because the parameters of neuropathic pain are so vague. It was a tremendous hit to us and I think comment here is entirely appropriate.

Pfizer could have protected itself if it had gone through a trial of Neurontin for neuropathic pain for pains which travel in the posterior columns (ie. the lemniscal pains of CP, such as muscle cramping, shooting pains etc.).

The problem was that doctors were not scientific and were giving Neurontin for ALL nerve injury pain, without proving its effectiveness in the burning dysesthesia, beyond the general reduction in nerve activity which is common to all antiepileptic drugs, many of which are much cheaper.

We are the same here. We talk of undifferentiated "neuropain", when this draws into the conversation pains from the front and the back of the cord, which do not really belong together.

So Pfizer got hit hard for vagueness. They would have been able to easily establish effectiveness had they limited things to posterior column pain.

Can anyone seriously suggest the US attornies could not find anything better to do than to go after Neurontin? Who knows what neuropathic pain is anyway.

[This message was edited by dejerine on 05-22-04 at 07:38 AM.]

[This message was edited by dejerine on 05-22-04 at 07:41 AM.]

[Wise Young]

Dejerine, as usual, thank you for our cogent and learned comments.

I think that it is useful to separate the issues a bit. It is important to emphasize that the FDA was originally established to protect the American public and preventing unscrupulous and unproven claims of commercial entities concerning efficacy of drugs and other treatments. It was never intended to control or restrict the prescribing activities of doctors.

It has never been and is not now "illegal" for doctors to prescribe drug for indications not approved by the FDA. The doctor is only liable if his/her actions does not follow the standards of medical practice which are established by medical practice and not FDA approval. Unfortunately, however, because of the way that our legal system is set up, the lack of FDA approval is sometimes used to sue doctors when they use drugs off-label. In other words, doctors who do off-label prescriptions are not protected by FDA approval of a treatment for a given indication.

Much medical use of drugs has no evidence base, much less an evidence base that is strong enough to achieve FDA approval. There is unfortunately a growing trend for insurance companies to use FDA approval as a reason to deny compensation for therapies. This development is unfortunate because the standards for FDA approval are very high. The FDA not only has stringent safety requirements but approval of a treatment for any particular indication requires two major phase 3 clinical trials. Even after approval, a drug company must continue phase 4 trials or long-term safety and efficacy trials; if a drug does not meet agreed upon safety and efficacy criteria over the long term, approval may be withdrawn.

Several people ask below whether Pfizer had applied to the FDA for the neuropathic pain indication. I believe that they are doing so but the clinical trials in this area have been very difficult for reasons that people here on this forum understand well:
1. Neuropathic pain is variable, not just among people but also in time within an individual. It can come and go, get worse or better, and change responsivity.
2. It is very difficult to carry out clinical trials where the trial subjects are not taking any other drug or doing things to stop or prevent pain.
3. Pain is difficult to quantify.
4. Causes and manifestations of neuropathic pain vary greatly.

Many doctors are consequently reluctant to prescribe treatments that are not approved by the FDA or insurance.

Wise.

[calico]

This is a tough one for me. If the allegations below are true:

"Franklin accused Warner-Lambert of hiring an outside firm to write at least 20 articles for medical journals that extolled unauthorized uses of Neurontin and then paid doctors for use of their names as authors of the reports, according to court documents."

Is this common practice in medical research? If it is, we're placing an awful lot of reliance on the integrity of both the drug companies and doctors. Seems like way too much conflict of interest.

Did Pfizer know it was stepping over the ethical and legal line? Hard to believe it didn't. Did it step over it almost 1/2 a billion dollars worth? How much harm was done to patients? I don't know, maybe none, maybe patients were helped more than hurt by this promotion. But if what Pfizer did was against the law, and the settlement had been for a slap on the wrist, what drug would they be illegally promoting for what indication the next time to the point that FDA approval becomes meaningless?

Personally, I would have liked to see a much smaller settlement, but a meaningful one, and I don't know what that number would be for a company like Pfizer unless it represents their profits from their illegal promoted uses of neurontin, and some level of punitive damages.

Calico

[Wise Young]

calico,

What Warner-Lambert did is not unusual. When I first heard of such practices, I was also shocked because I always felt that investigators should be writing their own reports. However, many companies simply do not want to place the future of multi-million dollar trials at risk if they have investigators that may not be good writers. In any case, firms that write the papers just provide a service. They gather the data, interview the investigators, and work with them closely to get the report written, make sure that all the data tables and graphs are scientifically correct, do the fact-checking, etc. They actually save time. The scientists would not (or should not) put their name on the papers if they did not think that the article reflects their views. A much greater danger, in my opinion, is when companies suppresses negative data or data that does not support a positive treatment effect. I don't think that this occurred here.

By the way, it is not illegal or unethical to use "ghost writers" to help put together scientific articles. Most scientists do it for each other. I must say that I have helped many scientists write their papers in the last 25 years. Nobody has ever paid me to do it, however.

Wise.

[Courtney]

"What Warner-Lambert did is not unusual. When I first heard of such practices, I was also shocked because I always felt that investigators should be writing their own reports. However, many companies simply do not want to place the future of multi-million dollar trials at risk if they have investigators that may not be good writers. In any case, firms that write the papers just provide a service." Wise Young

That would not be unusual if the purpose was to write a report on a good therpy. What you Dr. Young keep failing to acknowledge is these reports were written for uses of the drug that were known not to work. In a time when the research field needs trust to get the public to support stem cell research I find it deplorable that you have not spoken up at all against the drug company or the doctors that signed those reports. It won't work to blame it on the lawyers. Your bias support for the doctors and the drug companies is apprehensible. Thank god for the lawyers and the FDA or we might be taking tooth-paste for high blood pressure.
I also feel sorry for the people who had hope and took the medication that the drug company and the doctors already knew would not help their symptoms.

[dejerine]

Hold on. The real problem for me is that pain cannot current be measured. If it cannot be measured, errors by drug companies are understandable. Pfizer's ads probably hurt most by brainwashing docs, who then punished patients who didn't give them the response they wanted to hear--that medicine could chalk up another victory. Neurontin was not helpful for me,and yes I was stung by the gullible docs who questioned my pain because Neurontin did NOT help. Perhaps those upset at the medical profession had similar experiences. If so, the feelings of hurt are appropriate, as it gets tiresome to tell a doc he isn't helping you. They get pretty ticked off. They also tend to believe what they read, perhaps because neuropathic pain patients have no good vocabulary to communicate our pain.

The question for me is the way the court award was allocated. Who was speaking for the consumer? How about the half billion Pfizer lost, and what is the U.S. attorney in Boston going to do with the money, donate it to pain research? NOTHING really works for CP burning, but certain things help a little, particularly for the lancinating and muscle pains.

We certainly need an FDA. They provide an invaluable service, but they would be the first to admit their declarations are not holy writ. Remember, the Boston US attorney was not the arm of the FDA. I suspect you could put every attorney in Massachusetts on retainer for a quarter of a billion dollars. It was an excessive award of legal costs.

It would have been MUCH more appropriate to require Pfizer to spend their half billion on new research into genuine remedies for neuropathic pain, than to line the pockets of a single law office. What are they going to buy, gold plated copies of the U.S. Code? Platinum editions of Am Jur ? Diamond studded volumes of Corpus Juris Secundum? Give free Lexis subscriptions to the parking attendants?

I hate bad doctors as much as the next person and am appalled by the egotism of some, but I don't find any of that in Wise's posts. In fact, I am amazed he puts up with us cranky people who are in pain. Have you found anyone else who is curious enough to listen? Pain is unbelievable and deadly boring to those who don't have it. Just because no one else is interested, do we then begin to attack each other. Are we preaching to the choir? If so, our pain has impaired our perspective.

In my opinion, it is entirely normal for drug companies to employ acknowledged experts to test their products, and to pay them. Who else would they hire, and why shouldn't they pay them? Does this influence their opinion? No doubt, but I don't see how affording the US attorney in Boston a fortune that should have gone to patients, consumers and basic research will help. The penalty money should clearly have gone to Pain Research if the US attorney was acting solely in the public interest.

One cannot open a medical journal without seeing at the bottom of nearly every article some note of funding by a drug company. In fact, drug comanies fund more medical research than any other entity.

Wise is just telling you how things work. Don't kill the messenger. Why shouldn't he defend doctors? Are they guilty of some huge crime by giving Neurontin. There are many here who feel it helped them. I wish I were one of them. I suspect it is as good or as bad as other anticonvulsants.

Admittedly I have had very negative experiences, ghastly experiences with docs, like many of you, but I know where my hope lies, and I am not holding my breath for a lawyer to save me. And what other profession is running a web site to help your pain? Think on this and do not bite the hand that feeds you. Wise may get sick of us and find something better to do. I am grateful to the Boston US attorney for signaling that Neuronton wasn't all that great, but some sort of prescription refund or research grant would have been more appropriate for the court to award.

[This message was edited by dejerine on 05-25-04 at 03:23 AM.]

[calico]

Dr. Wise, I see your point, and the tone with which something is written greatly screws its meaning, such as:

"Franklin accused Warner-Lambert of hiring an outside firm to write at least 20 articles for medical journals that extolled unauthorized uses of Neurontin and then paid doctors for use of their names as authors of the reports, according to court documents."

I can understand why a drug company would want to control the content of a scientific article about its drug. I sure would. Hell, I wish I could write my doctor's reports to my LTD, or at least get to read and comment on them before they went out! http://sci.rutgers.edu/forum/images/smilies/smile.gif We can't expect doctors to spend their time reviewing and editing scientific articles for free, but as soon as money enters the picture, there is certainly the incentive for misrepresentation. I hope that doctors protect themselves from the appearance of undue influence by leaving a very clear paper trail that their review was objective. Of course, I hope their reviews are objective, but I don't think that can ever be guaranteed.

In this context, though, it appears that it is illegal to "promote" a drug for an unapproved use. I guess the case hinges on the definition of the word "promote".

I wonder how many trials for neuropathic pain Pfizer could have run for almost 1/2 a billion dollars. We've heard from a number of people on this forum and elsewhere who have been helped by the drug. I'm not aware that a subjective benchmark such as pain would prevent neurontin pain trials from being performed, so shouldn't they have just performed the trials?

Calico

[alan]

Neurontin apparently helps nerve-generated pain in some people, as do other anti-seizure meds. Docs weren't wrong to try it in such cases. Pfizer may have pushed it too hard before it was proven in trials to work on neuro pain.

Alan

"Was it over when the Germans bombed Pearl Harbor?"

[Kendell]

My life partner has been in severe,chronic pain for the better part of her life due to a long list of injuries and illnesses. A R AKA led to her developing a nerve tumor in her stump which causes her to have phantom pain so extreme it makes her scream at times. The one and only med - out of many that have been tried - that has helped is Neurontin. It isn't perfect, but it makes her life tolerable.

While it may well be true that the FDA is a necessary agency to prevent potentially serious tragedies via pharmaceuticals, the fact is that Neurontin has been used for neuropathic pain for some time, and there are a lot of very human beings in this country who are going to be extremely hurt if they can no longer get Neurontin from their doctors. Perhaps Pfizer did jump the gun with their claims about what Neurontin can and can't do - but for those who have had it proven to them already and for some time now that it does help - the idea of having it taken away is a horror. At least it surely is for my partner, and I"m betting she has plenty of company.

For me, the human factor is the bottom line. Make Pfizer do the trials - fine - but don't deprive those who have suffered enough already from a medicine that may be their only ray of light to date.

[metronycguy]

yes worked well with my central pain which is at my l4/l5/s1 level pain is in my foot from spine injury cauda equina syndrome. i was in screaming agonizing pain constant shocks every 2 or 3 sec, horrible stuff. it workes well with elavil

[calico]

It seems like doctors can still prescribe it for nerve pain just like they have been. I doubt that a doctor who has a patient who says it has helped them would cut them off, or stop trying it on other patients. Am I being overly optimistic here? It's not like it's been shown to be highly addictive, which does scare doctors away.

Calico

[howboutdis]

Wise Young

Administrator

posted 05-18-04 08:15 PM
jpw,

I did not mean to bash lawyers but over half of the amount went to the U.S. Attorney's office in Boston, presumably to cover the costs of the legal prosecution of the case.

By the way, methylprednisolone has not yet been approved by the FDA for use in spinal cord injury.
Wise.



By the way Wise do you know that methylprednisolone is on back order by Pfizer! Why? do they chose to devote their time to making more profitable drugs that are still covered by a patent? For reasons why it is not a standard of treatment do you remember the good old days when you said this? "I believe that one of the motivations of doctors who decry the value of methylprednisolone is that they have been sued for not using the drug. This is why they keep trying to say that it is not a "standard of care", so that they cannot be sued for not using it."
[URL= http://carecure.org/forum/showpost.php?p=131237[/URL]

[Wise Young]

howboutdis,

I have heard that one of the reasons why methylprednisolone is on back order by Pfizer is because there was a huge upsurge of methylprednisolone use in China where it is being used more for spinal cord injury and recently for SARS (it is the front-line drug to treat patients with SARS). Also, I should point out that methylprednisolone is the standard of care for people with an exacerbating attack of multiple sclerosis. However, I think that the shortage has abated. But, you are right. In December 2003, the shortage was so acute that scientists were calling my lab to see if we have any methylprednisolone to treat their rats! All methylprednisolone in the U.S. were reserved for emergency use in the United States.

Wise.

[howboutdis]

Why do you only talk about rats?"200 bed teaching hospital. General medical. My suggestions We clamped down on use of Solumedrol for COPD'ers - we recc Dexamethasone for those patients Reserve for Spinal cord inury and/ or MS, and/or your most severe pt population. Consult with Pulm, Neurology Internal Medicine regarding alternatives, gt specialists to sign off on reccomended alternatives when managing the issue with prescribers. Re-educate nursing as well as prescribers about the less often used alternatives so they can prescribe and give it safely. Use this as an opportunity to build a comfort level with prescribing ORAL agents when appropriate! Make decisions assuming that you will run out; with no return date known. ( eg, what will you do for MS, spinal cord injury when it's gone? Make sure you have prepared for the hydrocortisone shortage in the same fasion."not just rats (http://www.ismp.org/forum/?m=2185) "Abbott has indefintely suspended production of its corticosteroid products in order to ensure adequate production of other medications.1 Pharmacia's products are on nationwide back order due to increased demand for the product and manufacturing capacity issues." Nothing about Sars or rats (http://www.ashp.org/shortage/methylprednisolone.cfm?cfid=15189173&CFToken=47322507)

[howboutdis]

Was it just a shortage for RATS? "NATIONAL SHORTAGE OF I.V. METHYLPREDNISOLONE (SOLUMEDROLÒ)



The Pharmacy is making physicians, nurses and other health professionals aware of a potential shortage of the intravenous glucocorticoid methylprednisolone. This is a result of a manufacturing problem, and no alternative source is available. This shortage does not involve other dosage forms of methylprednisolone (oral MedrolÒ), nor does it involve other glucocorticoids such as prednisone, prednisolone, hydrocortisone or dexamethasone. Current supplies of I.V. methylprednisolone (Solu-MedrolÒ) should last several weeks.

Physicians and other prescribers who routinely order I.V. methylprednisolone (Solu-MedrolÒ) should immediately begin revising their prescribing practices AND PRE-PRINTED ORDERS in anticipation of this temporary shortage. It is reasonable to consider substituting either I.V. hydrocortisone (Solu-CortefÒ) or I.V. dexamethasone (DecadronÒ).

Methylprednisolone has intermediate glucocorticoid and mineralocorticoid potency with an intermediate duration of action (12 - 36 hours). Hydrocortisone is less potent as a glucocorticoid than methylprednisolone, has more mineralocorticoid effect and has a duration of action of 8 - 12 hours. Dexamethasone is more potent as a glucocorticoid than methylprednisolone, has less mineralocorticoid effect and has a duration of action of 36 - 72 hours.

The approximate conversion for glucocorticoid effect (anti-inflammatory effect) is:

hydrocortisone (cortisol, Solu-CortefÒ) 20 mg

methylprednisolone (Solu-MedrolÒ) 4 mg

dexamethasone (DecadronÒ) 0.75 mg

For example, if a physician wanted to substitute dexamethasone for methylprednisolone, he/she would divide the Solu-MedrolÒ dose by 5.3. Instead of giving 40 mg of Solu-MedrolÒ, give 7.5 mg of I.V. DecadronÒ, for example. If the physician desires some mineralocorticoid effect from the glucocorticoid, he/she needs to prescribe hydrocortisone (Solu-CortefÒ). The methylprednisolone dose would be multiplied by 5 to calculate the hydrocortisone dose. Instead of giving 40 mg of Solu-MedrolÒ, give 200 mg of Solu-CortefÒ.

Prepare for the possibility that I.V. methylprednisolone (Solu-MedrolÒ) will not be available. Choose whether to substitute dexamethasone or hydrocortisone.
MP shortage (http://library.osfsaintfrancis.org/PharmacyDocs/Pharmagram/2000/pharma8.htm) By the way the shortage is not expected to clear up till 2005. So Pfizer pushes drugs for un proven treatments and gets doctors to sign reports that they are good treatments, but yet the drug industry back orders a treatment that can help restore a few levels.