Promoting a drug to treat a disorder for which the FDA has not approved it -the federal crime for which Merck must pay a $950 million fine in connection with Vioxx, as reported here Nov. 28- will become the legal exercise of free speech if pharmaceutical manufacturers hold sway in the federal courts.
Big PhRMA’s push to legalize “off-label marketing” as the practice is known, was described in the Wall St. Journal Nov. 29. “Doctors routinely prescribe such therapies as a hemophilia drug for brain hemorrhage, and cancer drugs for a wider array of tumors,” explained Thomas Burton. “But drug companies can’t market those uses thanks to decades-old restrictions from the Food and Drug Administration.”
The U.S. Supreme Court ruled in June that a Vermont law preventing drug companies from using pharmacy records to facilitate sales violated the First Amendment. In July, seven drug companies petitioned the FDA to scrap their restrictions on marketing methods.
The Supremes’ striking down the Vermont law is likely to influence a federal appeals court in New York that is reviewing the conviction of Alfred Caronia, a salesman who pushed Xyrem -a drug the FDA approved as a treatment for narcolepsy- for drowsiness and chronic fatigue.
According to the WSJ, “Big drug makers, emboldened by decisions of the high court, have jumped into the Caronia appeal. In a ‘friends of the court” brief… Pfizer, GlaxoSmithKline PLC, Johnson & Johnson and eight other companies wrote that ‘off-label use is a necessary and common practice,’ and that applying the FDA’s off-label rules to Mr. Caronia’s alleged conduct ‘appears to be constitutionally indefensible’ given the Supreme Court ruling.”
In mid-October, Par Pharmaceutical, Inc. filed a complaint against the FDA and the Department of Health & Human Services, arguing that the existing rules prevent “truthful and non-misleading speech to healthcare professionals concerning the FDA-approved use of its FDA-approved drug.” Par has FDA approval to market Megace, an appetite-stimulating hormone, as a treatment for AIDS wasting syndrome, and wants to sell it to old-age homes where it will inevitably be prescribed for other conditions.
“Companies have paid a high price over the last two decades for allegedly violating off-label marketing rules,” writes Burton (not mentioning how much the companies made in the process). “Of 31 drug cases settled under the False Claims Act from 1996 through 2010, 15-totaling $8.7 billion-involved off-label or fraudulent marketing and the related charge of misbranding.”
David Graham, MD, a reviewer in the FDA’s Office of Safety Research, testified before the Senate Finance Committee in November 2004, that some 140,000 Americans suffered Vioxx-induced heart attacks and strokes, and 55,000 died as a result. Extrapolating from the number of U.S. users (25 million) to the number of users worldwide (80 million), your correspondent exaggerated Merck’s criminality. The worldwide death toll would have been “only” in excess of 165,000. The total of Vioxx-induced heart attacks and strokes would have exceeded 420,000…. Also, it was the FDA’s Office of New Drugs, not the Office of the Director, that tried to squelch warnings by Graham.
A Victim of Off-Label Marketing
In response to the Merck piece —and on the day the Wall St. Journal reported Big PhRMA’s push to legalize off-label marketing— came this note from Daniel Haszard of http://www.zyprexa-victims.com
“Zyprexa (Olanzapine) is an ‘atypical antipsychotic.’ Its mechanism of action is thought to be that it increases levels of serotonin and dopamine. Its chemical name is thienobenzodiazepine although it is not a benzo like Valium. One of its well-known major side effects is weight gain, which is why it is sometimes favored for those with eating disorders (which would be an off-label use).
“Doctors are at liberty to prescribe drugs ‘off label’ like Zyprexa which is only FDA approved for schizophrenia and bipolar. They can give it or just about any drug for conditions other than what the drug was tested for. The doctors don’t realize that Zyprexa is very addictive once a dependence has been built up and withdrawal is wicked.
“I took it 1996-2000 for PTSD and it was worthless for my symptoms and gave me diabetes with a blood sugar level of 15 (normal blood sugar is 4).
I had to get off it and it took me two months of horrible insomnia… So, be warned Zyprexa is addictive. I think worse than nicotine. Don’t go off it unless you do so gradually under a doctor’s care.
“Lilly pleaded guilty to criminal wrongs for their ‘Viva Zyprexa’ campaign. Eight Lilly employees got about $8 million each as supposed informant ‘whistle blowers.’ Lawyers on both sides got millions. And most patient claimants who got sick are ‘mentally challenged’ and less able to advocate for themselves… Zyprexa is way, way over-prescribed.”
Vioxx, Jr. available in Europe
This came from a medical researcher in Germany: “Merck is currently marketing a follow-up COX-2 inhibitor in Europe called Arcoxia. It is chemically quite similar to Vioxx (different enough for patent protection, my chemist colleages tell me), and has precisely the same mechanism of action. The package insert includes a black box warning that persons with cardiovascular risk factors should perhaps reconsider taking the stuff. The FDA refused to approve Arcoxia in the US in 2007. I was prescribed Arcaxia for knee pain (before I realized that I was taking Vioxx Jr.). I noticed no pain relief at all, and switched to naproxen (which, like aspirin, is cardioprotective). More recently, after an Achilles tendon operation, during which the anaesthesiologist observed a suspicious arrhythmia, I was given Arcoxia. I pointed out to the doctor that perhaps another medication would be in order – he was obviously embarrassed to have this pointed out by a patient in the presence of six medical students!
Tonight, the first episode of a four-part reality show airs on the Discovery Channel. “Weed Wars” is a behind-the-scenes look at Oakland’s Harborside Health Center, the biggest Cannabis dispensary in the world. I’d been told that Steve and Andrew DeAngelo, the executive director and general manager, were supposed to appear on Bill O’Reilly’s show Tuesday night. It had been a while since I’d caught his act. They’ve dyed his hair an undignified Senatorial orange, but they left the sides gray. Interesting look.
The first bit was Big Bill and the bloodthirsty blonde from the McLaughlin Report smacking around Alan Coombes, the impotent foil who used to take it from Sean Hannity. Next was O’Reilly having a fake-collegial chat with Glen Beck, who is all relaxed and smiley now (on a new drug regimen, obviously). The little goofball was shilling for his new book, “George Washington, man of character.” O’Reilly has put out a book called “Killing Lincoln.” They referred to the father of our country and the great emancipator as “my guy” and “your guy.”
“Horrific murder of American by Illegal Immigrant!” had been plugged on the teasers as a big story. A Mexican citizen in jail for committing a sexual assault on his wife in a Texas town gets released (instead of deported, O’Reilly points out repeatedly), shows up at a party at the ex’s, yells at her and the new boyfriend, is told to leave, heads for his car, followed by taunting new boyfriend, who he then shoots. Why is this everyday occurrence national news? O’Reilly says there’s been a cover-up, demands to know “which federal agency let this illegal immigrant out to murder an American?” The shot widens to include a blonde lawyer suggesting that the Justice Department was involved in the man’s release, and Kimberly Guilfoyle, one of Fox’s regular legal analysts. O’Reilly goes “Aha! The Justice Department! Eric Holder!” Kimberly Guilfoyle is radiating annoyance at having to share space on the set with the vapid blonde. I worked closely with her when she and Jim Hammer were prosecuting the famous San Francisco dog mauling case. As the DA’s press secretary, I was liaison to a raging scrum of tabloid reporters, most of whom knew each other from the OJ Simpson trial.
The sentencing of Michael Jackson’s doctor had become the focus of The Factor. Kimberly said she would have charged second degree murder. The blonde said the case had been properly charged but people sentenced to four years should do four years behind bars. A duel to show cruel… I could feel Kimberly’s desire to strangle the blonde from 3,000 miles away.
Where were Steve and Andrew DeAngelo? Bumped by news of Barney Frank’s retirement, apparently.
I’d crossed paths with him, too, c. 1960, at a softball game in Cambridge, the Crimson against the Lampoon. The bespectacled loudmouth from the Bronx, no jock, was standing behind the pitcher calling balls and strikes and keeping up a very funny running commentary. Years later we had an unpleasant encounter in Oakland at a fundraiser for Barbara Lee. Barney had given a talk blaming Ralph Nader for having cost Gore the presidency. I told him (I just looked it up): ” Gore would have won by a theft-proof margin if he had allowed Nader to take part in the debates. Nader would have come across as the intellectual on the left, Bush as the frat boy on the right, and Al Gore would have been the solid Everyman in the center, just where you want to be in a presidential race. Without Nader, Gore came across as the wonk-liberal (the ambitious smart kid, now grown up) and Bush as the folksy conservative (the dumb but “popular” kid). Gore kept Nader out of the debate because his political instincts —and the party leaders’ political instincts, including yours, Barney— are anti-democratic. Without a semblance of a left in American politics, the Demos don’t look like the centrists they really are.”
The finale: a supercilious Charles Krauthammer commentary on “the legacy of Barney Frank.” As he speaks, the pundit’s eyelids droop almost entirely shut, as if it’s hard to stay engaged while explaining things to dimwits. O’Reilly treated him with deference —no interrupting or barking at Krautie. I flashed on the pedophile priests sent to the Jewish shrinks for counseling and clearance to return to the flock.
Fred Gardner edits O’Shaughnessy’s, the journal of cannabis in clinical practice. Gardner is a contributor to Hopeless: Barack Obama and the Politics of Illusion, forthcoming from AK Press. He can be reached at email@example.com