In my previous post someone calling himself Bruce Alan commented,
A hypoglycemic person is also more likely a hypersensitivity-prone person. Have you read the December 2007 warnings the FDA ordered Cephalon to place, in bold large-type print, on its Provigil labels?
Keep promoting Provigil and you’ll soon be killing patients unnecessarily just like a real doctor.
This is obviously one bitter individual. It isn’t necessary to analyze all of the drug warnings. I’ll leave that to the academic journals. All I need to say is that every drug, indeed everything in life, has risks and benefits. If you were to get paralyzed in a car accident on the way to work you wouldn’t advise people to stop driving. You might advise them to exercise more caution, but you would recognize that the benefit of driving outweighs the associated risks. Likewise. it is irrational to advise individuals to forswear a drug entirely because of rare side-effects. People can be killed by almost every drug; this is why doctors carefully examine an individual prior to issuing a prescription and then monitor that individual’s health afterwards.
I did a google search on Mr. Alan, and discovered details he has publicly reported of his case. The most detailed I found was posted on WebMd.com. Mr. Alan alleges,
PROVIGIL KILLS. Read this again: PROVIGIL KILLS…For over a decade, Provigil’s manufacturer, Cephalon, has been promoting this drug as a safer alternative to Dexedrine or Adderall for ADHD. One of their sales reps talked my doctor into switching me from Dexedrine to Provigil because it was safer. At the time (2 years ago) I had taken Dexedrine for 12 years with no side effects. Within a week after I reached the ‘target’ dosage I went into psychotic delusions, my blood pressure went down to 75/40, I went into cardiogenic shock, acute kidney failure, acute heart failure and suffered significant brain damage. I spent 20 days in the ICU and my doctors estimated that, simply for not dying within 24 hours, I had overcome odds of 200 to 1…My advise [sic]? Take Dexedrine if you are diagnosed with narcolepsy or shift sleep disorder. The amphetamines in pill form are FAR less likely to cause side effects and infinitely less likely to kill you. Believe me — I know; I am now permanently disabled because of Provigil.
What Mr. Alan has alleged is powerful; powerful enough to garner the interest of a personal injury attorney and the US Department of Justice. If what you said is the truth, and the whole truth, you would be a multimillionaire today. Of course, I highly doubt that you have given us the entire story.
If your story were true, you would have taken the following action:
- Sued Cephalon (because the drug rep “convinced” your doctor to change your medications.
- Sued your prescribing physician (because your physician changed your medications for no legitimate medical reason and it cause you harm)
- Urged the Justice Department to press charges against the drug rep in your case.
I am sure that Mr. Alan is aware that legal proceedings are a matter of public record. If his claims are something other than a mixture of exaggeration and fiction, I am certain that he will have no problem accepting my challenge: Put up, or shut up! Provide us with links to the court documents that you have filed. If you claim that you settled without ever filing a single document in a court of law, give us a link to the documents showing that you sued your lawyer for malpractice. What you describe is serious impropriety, and that merits a large judgment, not some petty settlement. We will then have a look at the what you claim to be the case.
PUT UP OR SHUT UP
I doubt that you will provide us with such links because I doubt that they exist. Your fantastic story is not to be believed!
N.B. Mr. Alan would be well advised to refrain from making blanked drug recommendations. He is not a doctor, and he has not ever examined those who might take his advice. I don’t know whether not Dexedrine is “safer” than Provigil, and I don’t have to to climb through medical journals to compare benefits and hazards. Moreover, to label a drug as safe or unsafe is to oversimplify the issue. Mr. Alan may have a simple mind, but I do not.
Mild allergic reactions are indeed possible with almost any drug. I was not referring to mild reactions and neither was the FDA when it released the statement below in December 2007, which I suggested that you read in my first comment. Contrary to your suggestion, the FDA does not require ‘Black-Box’ or ‘bold-print’ changes to a drug manfacturer’s label, as it did for Provigil, if the reaction is only moderate or if it causes deadly reactions in ‘just’ one or two hundred people. I doubt that any more than a few dozen prescription drugs out of the many thousands in use today to carry a bold-print FDA warning label mandated by the FDA AFTER rather than before the drug is released.
Not that there have only been just a few dozen such drugs declared by the FDA to be potentially fatal. There have been hundreds over the decades — it’s just that the requirement of a post-release warning such as what the FDA required of Provigil is often a prelude to an order by the FDA that the drug in question be banned altogether from being sold in the United States.
You also challenge my statement that Provigil’s manufacturer, Cephalon, has been illegally promoting Provigil for uses it was not approved for. Below is also a copy of an article which appeared in the Philadelphia Inquirer which appeared a few months ago after the FDA had concluded that Cephalon had indeed, as a matter of company policy since 2002, instructed its sales representatives to actively promote Provigil to primary care doctors and psychiatrists for the treatment of ADHD (along with depression and Alzheimer’s disease) and many other conditions for which Provigil was not and is not authorized to be used for the treatment of.
Regarding the culpability of the doctor who prescribed my Provigil ,the rules are strangely contradictory: while drug manufacturers are subject to the sort of huge, hige fines that were recently leveled upon Cephalon when they actively PROMOTE unauthorized uses of their drugs, the prescibing physicians themselves are permitted to prescribe any prescription medication to treat any conceivable medical condition. A doctor commits no punishable offense if he prescribes a drug for what is termed an “off-label” use, provided that the FDA has already approved the drug’s use for ANY condition, whether related to the condition the doctor is using it for or not.
I have no other comment as to my filing of legal action against Cephalon and others for the injuries and disability that I suffered shortly after I began taking Cephalon’s drug, Provigil.
Somehow, I managed to survive cardiogenic shock, multiple organ failures, significant brain damage and eospinophilia, and now apparently am developing chronic kidney disease likely to result in the need for a kidney transplant. Given the length of time that has since passed, (compounded, unbelievably, by additional brain and other injuries I sustained in an automobile accident 10 months later) the odds that I will return to my professional practice of 26 years are all but nil. What I can do as this point in my recovery is to tell people where I can about what happened to me, to the others who survived similar life-shattering experiences, and to the likely far greater percentage of users who, unlike us, failed to surmount the incredibly long odds of of surviving Provigil hypersensitivity.
Yes, the FDA warnings are a matter of public record, but if they are like you they will not bother to review them because you continue to assume, along with the great majority of patients AND PHYSICIANS, that Provigil is a safe drug instead of the killer drug that it truly is.
brucealan@gmail.com
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Cephalon fined $437M for pushing ‘off-label’ use
Date Added: 2008-10-01 06:30:02
Philadelphia Daily News via NewsEdge :
Sep. 30–Drugmaker Cephalon has agreed to plead guilty in federal court to distributing misbranded drugs and to pay $437 million in fines, forfeitures, interest and civil claims.
Cephalon, headquartered in Frazer, Chester County, develops and markets drugs to treat cancer-related pain, sleep disorders and epilepsy, among other medical problems.
From 2001 into 2006, the company marketed the drugs Actiq, Gabrivil and Provogil for uses other than what federal regulators approved, and will pay a $40 million fine and $10 million in forfeiture.
Cephalon has also agreed to pay $375 million plus $12 million interest to settle civil claims brought by federal agencies and state Medicaid programs. (The state Medicaid programs and the District of Columbia will share $116 million of the settlement.)
The feds said the off-label marketing of the three drugs began in January 2001 and continued through at least 2006, but the parties stipulated in the plea agreement that the conduct went from January 2001 through Oct. 1, 2001.
Cephalon did not admit any liability or wrongdoing as part of the civil settlement tentatively approved last November.
Doctors can prescribe drugs for uses other than what has been approved by the FDA, but drug companies cannot promote such “off-label” uses, authorities said.
“This company subverted the very process put in place to protect the public from harm, and put patients’ health at risk for nothing more than boosting its bottom line,” said acting U.S. Attorney Laurie Magid.
Actiq is used to treat pain in cancer patients and is dispensed as a lollipop. Gabitril is an anti-epilepsy drug used to treat seizures, and Provogil is used to treat excessive daytime sleepiness associated with narcolepsy and sleep apnea.
Authorities said that Cephalon’s sales reps promoted Actiq for uses in injuries and migraines; Gabitril as a remedy for anxiety, insomnia and pain, and Provogil as a drug for the treatment of sleepiness, lack of energy and fatigue.
Authorities would not say who tipped them off to Cephalon’s sales practices, but four whistleblowers — including three former Cephalon sales reps — had filed lawsuits in federal court. They will receive $46.7 million from the federal share of the settlement.
Magid said that authorities had reports that some patients who had been taking the drugs for off-label uses were harmed and that some even died, but she couldn’t say whether the off-label use of the drugs was the result of off-label marketing.
In 2005, following reports of seizures in patients taking Gabitril who did not have epilepsy, the FDA required Cephalon to send a warning letter to doctors.
Afterward, Cephalon stopped promoting the drug, authorities said.
The FDA sent Cephalon a letter in 2002 instructing the company not to promote Provogil off-label, but Cephalon ignored the letter, the feds said.
Sales of Provogil, for example, increased from $146.2 million in 2001 to $691.7 million in 2006, the feds said in the plea agreement
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FDA Release:
Modafinil (marketed as Provigil): Serious Skin Reactions
FDA has been monitoring cases of serious skin reactions, including erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), in its postmarketing reviews of adverse event reports associated with the use of modafinil. The product labeling for modafinil has been recently updated to include a bolded warning for serious rash, including SJS.1 Based on postmarketing data for modafinil, a recently approved drug with a similar chemical structure, armodafinil, includes a similar bolded warning in the product labeling.2 Healthcare professionals and patients should be watchful for skin reactions associated with the use of modafinil and armodafinil and report cases to FDA’s MedWatch.
Modafinil (Provigil) is an oral wakefulness-promoting agent to treat patients with excessive sleepiness (ES) associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), and shift work sleep disorder (SWSD).1 Modafinil is a controlled substance (C-IV) and has been available in the United States since 1998. The safety and efficacy in children under the age of 16 has not been established.
From the date of initial marketing, December 1998, to January 30, 2007, FDA received six cases of severe cutaneous adverse reactions associated with modafinil, including erythema multiforme (EM), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) involving adult and pediatric patients.
The 6 cases from the United States occurred in four females and two males aged 49, 42, 17, 27, 15, and 7 years old, respectively. The median time-to-onset of adverse dermatologic effects following initiation of modafinil therapy was 17.5 days, ranging from 5 days to 5 weeks (see Table). Patients presented with a rash to either body extremities (arms, hands, and legs) or to the whole body with some experiencing eruptions in the mouth (lips, tongue), eyes, or genitals. In addition, some patients developed skin pigment changes, pruritus, ulcers, burning of the skin, mild skin scaling, sloughing, and/or fever. Skin biopsies from four patients confirmed TEN, SJS/TEN, SJS/EM, and eosinophilia with unspecified findings consistent with a drug hypersensitivity syndrome.3,4
There were no deaths. Five of 6 patients required hospital admission for management, including one patient with TEN who was admitted to the surgical burn unit 20 days after starting modafinil at recommended doses to treat a sleep disorder. In this case, the rash affected 50% of the total body surface area (BSA), with 20 to 30% of the skin denuded. Although this patient had an extensive medication history, modafinil was the primary suspect drug because it was the last agent added to the patient’s drug regimen. In addition, modafinil discontinuation upon hospital admission coincided with patient improvement, despite continuation of other concomitant medications, such as celecoxib and propranolol, which have labeled warnings for TEN.
In one case of SJS, although potentially confounded with Lamictal therapy (labeled warning for SJS), rechallenge with modafinil resulted in recurrence of the rash including oral mucosal involvement, which supported a causal association with modafinil use. Modafinil was subsequently discontinued. In the SJS/TEN case, a 42-year-old female received concomitant medications (including escitalopram, which has a labeled warning for TEN) since 2005 without incidence before adding modafinil for sleep disorder in 2006. The patient’s extensive body rash (30% of the body surface area), skin biopsy, and clinical presentation all aided the dermatologist in diagnosing SJS with overlapping TEN.
One case of DRESS syndrome was reported in a 15-year-old who was started on modafinil for attention deficit hyperactivity disorder (ADHD), an unapproved indication. After 5 weeks of therapy, the patient developed a skin rash that progressed with multiple organ system involvement, including the cardiac, renal, respiratory, and pancreatic systems. Based on the clinical presentation, increased eosinophil count, and skin biopsy results, the consulting dermatologist diagnosed DRESS syndrome.
Although some cases were potentially confounded by drugs known to be associated with serious skin reactions, all cases had features that implicate modafinil. The cases described a temporal relationship with detailed clinical descriptions, relevant laboratory data, dermatologist-substantiated diagnoses, skin biopsy confirmation, positive dechallenges, and/or a positive rechallenge, all of which support an association between modafinil use and serious cutaneous skin reactions.
1) You don’t know what you’re talking about.
2) I never claimed that Cephalon didn’t violate the law; I questioned whether they did so in the manner in which you described, which would give you cause to file your own claim against them.
3) Yes, doctors can and routinely do prescribe medications for off-label uses. That they are allowed to do so does not shield them from liability if they do so inappropriately. If a physician changes your medications for no good reason, and then you proceed to sustain serious harm because of that change in medication, that physician has committed malpractice. The key there is: they prescribed the drug FOR NO GOOD REASON. I suspect that in your case, whatever your case may be…that your physician had a very good reason that had nothing to do with a drug rep whispering in his ear.
4) I do not assume that Provigil is without risks. I am well aware of the risks associated with it, and in my own case I have judged them to be worthwhile. I don’t have a prescription pad yet; I haven’t finished medical school. I assure you that when I get my prescription pad I will do my due diligence on every drug I prescribe. That doesn’t mean bad things can’t happen, it means the potential benefits outweigh the hazards.
5) In your post on WebMd, you advised people to take Dexedrine instead of Provigil. I have never given anyone such medical advice. Indeed, none of my posts here constitute medical advice. I couldn’t imagine any competent medical professional saying, “in each and every case, everyone should take drug X instead of drug Y.” Of course, you are not a medical professional, you’re just some guy with a chip on his shoulder and an internet connection.
6) Put up or shut up. If you didn’t file suit, what you claimed took place did not. Goodbye!
FYI: Mr. Alan the armchair physician left another comment, but it was unfit for public discourse. He should be ashamed of himself. He is hereby banned from further comments on this blog. I do not know what is wrong with him, but I am quite certain that Provigil has nothing to do with it.
It is quite difficult to find fulfillment and happiness while trolling from one’s mother’s basement, nonetheless I wish him luck. My regular, insightful readers are welcome to post goodbye messages for him here, since he will not be allowed to comment further on this blog.