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PHARMA/POLICY: DEA insanity continues–Dr. Hurwitz Convicted

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I’m a little late as this happened last week, but it has to be reported even though it makes me very angry. The DEA and its poodles in the DOJ have succeeded in getting Dr. William Hurwitz Convicted on 16 Counts of Drug Trafficking. Hopefully Hurwitz will be out of jail relatively soon—although no guarantees. He’s served 2 and a half years for just being a doctor, and could serve up to 18 more.

Unfortunately the chronic epidemic of untreated pain goes on and on. As I pointed out in Spot-on last year :

45 to 80 percent of nursing home residents have substantial pain.  The consequences of poor pain management include sleep deprivation, poor nutrition, depression, anxiety, agitation, decreased activity, delayed healing and lower overall quality of life. Fewer than half of nursing homes residents with predictably recurrent pain were prescribed scheduled pain medications

So we have a massive health problem, and the DEA acts like a bunch of brownshirts, going after pain doctors. Listen to Tierney’s account of one of the patients from the doctor that the prosecution used.

Then, during cross-examination by the defense, Dr. Hamill-Ruth was shown records of a patient who had switched to Dr. Hurwitz after being under her care at the University of Virginia Pain Management Center. This patient, Kathleen Lohrey, an occupational therapist living in Charlottesville, Va., complained of migraine headaches so severe that she stayed in bed most days. Mrs. Lohrey had frequently gone to emergency rooms and had once been taken in handcuffs to a mental-health facility because she was suicidal. In 2001, after five years of headaches and an assortment of doctors, tests, therapies and medicines, she went to Dr. Hamill-Ruth’s clinic and said that the only relief she had ever gotten was by taking Percocet and Vicodin, which contain opioids.

Mrs. Lohrey was informed that the clinic’s philosophy “includes avoidance of all opioids in chronic headache management,” according to the clinic’s record. The clinic offered an injection to anesthetize a nerve in her forehead, but noted that “the patient is not eager to pursue this option.” Mrs. Lohrey was referred to a psychologist and given a prescription for BuSpar, a drug to treat anxiety, not pain.“You gave her BuSpar and told her to come back in two and a half months?” Richard Sauber, Dr. Hurwitz’s lawyer, asked Dr. Hamill-Ruth. Dr. Hamill-Ruth replied that unfortunately, the clinic was too short-staffed at that point to see Mrs. Lohrey sooner. Under further questioning Dr. Hamill-Ruth said that she was not aware that BuSpar’s side effects included headaches.

Mrs. Lohrey looked elsewhere for help. Having seen Dr. Hurwitz on television _ — “60 Minutes” and other programs had featured his controversial high-dose opioid treatments — she sent him a letter describing her pain and the accompanying nausea and vertigo.“I have lost hope of retrieving my life as it was,” she wrote, because she could find no doctor to take her seriously. “I currently have a physician who has said that I am psychologically manufacturing my headaches, and that I am addicted to narcotic pain relief. This of course is not the first time that I have been treated as a ‘nut’ or a ‘junkie.’ ”

<SNIP>

“I felt that I had a duty to the patients,” Hurwitz said. “I hated the idea of inflicting the pain of withdrawal on them.” After the closure of his practice in 2002, he said, two of his patients committed suicide because they gave up hope of finding pain relief. The most moving testimony came from Mrs. Lohrey and other patients who described their despondency before finding Dr. Hurwitz. They said they were amazed not just at the pain relief he provided but at the way he listened to them, and gave them his cellphone number with instructions to call whenever they wanted.

“I felt like I was his only patient,” Mrs. Lohrey testified. “I think he truly understood the nature of what I was going through.” When she lost her health insurance, she said, Dr. Hurwitz continued treating her at no charge, and helped her enroll in a program that paid for her opioid prescriptions. After Dr. Hurwitz’s practice was shut down, she could not find anyone to treat her for seven months. Eventually, she found a doctor willing to prescribe small numbers of low-dose Percocet, but she said she was not getting enough medicine to consistently blunt the headaches.

“The last two weeks, I was pretty much in bed and sick with the headaches and the nausea and the whole nine yards,” she said, explaining that she had deliberately undergone the two weeks of pain in order not to use up any of her pills. “I had to save up medication,” she testified, “so I could be here today.”

Tell me which physician was guilty of malpractice, and why on earth one of them deserves to be in jail?

PHYSICIANS/PHARMA: Fool me once-shame on you. Fool me twice…..er won’t get fooled again? by The Industry Veteran

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So there’s been a fair amount of fuss about a new paper by two academics, one a former drug rep, about the tricks big Pharma uses to “fool” physicians when it details them. You may not be impressed and may be willing to blame Pharma with its cheerleader sales reps and beauty queen detailers. The Industry Veteran, in his usual gentle style, assigns blame elsewhere. You have, as usual, been warned!

This newswires and every health care site in the blogosphere carried a story about a former Lilly rep who published an article about the sales tactics that pharma reps use to influence physicians’ prescribing. I’m shocked and horrified — NOT! So pharma reps have been taught Sales Skills 101. What the hell, are physicians such delicate flowers that they must not be subjected to the lures of salesmanship? Sorry if I appear obtuse, but I don’t see anything disreputable if a rep assesses the type of physician he’s seeing and tailors a pitch to that type.

Continue reading…

PHARMA/POLICY: John Tierney covers the Hurwitz Trial

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John Tierney, who sadly gave up his libertarian op-ed column in the NY Times reports on the William Hurwitz trial. Regular THCB readers will remember how appalling the DEA is in its draconian persecution of pain doctors, and how they deliberately changed their own guidelines during this trial and removed them from their website because the defense was going to show that Hurwitz prescribed by them.

If I believed in hell, I’m sure that DEA head honcho Karen Tandy would be going there for her statement that Hurwitz deserved 25 years because he “was no different from a cocaine or heroin dealer peddling poison on the street corner.” But apparently Tandy’s travels are instead taking her to more interesting locales at the taxpayer’s expense.

PHARMA: 60 Minutes on the MMA

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60 Minutes on Sunday had an entertaining story about the Medicare drug bill’s passage in late 2003. Not exactly new news, but a fun retelling of how Tom Delay, and PhRMA rammed the bill through literally by holding the vote open for three hours and torturing the crap out of any Republican who was a fiscal conservative and likely to vote no.

What amazes me was that any Republicans at all felt squeamish about that. Hadn’t they seen how Delay operated? Hadn’t they met a PhRMA lobbyist in their time in DC? Hadn’t they noticed the Administration cow-towing to industry in every other sphere of government? Didn’t they know that every possible opposition group was bought off in the bill? Hadn’t they noticed the deficit going through the roof?

And what’s the relevance of telling the story again three and a half years later?

(CODA: Dan Burton, one of the Republicans interviewed, is actually somewhat interesting. For example he’s a long time drug war loon, but in 2002 he actually said some interesting things about the drug war almost hinting at the fact that he realizes what a waste of time and money it is. So maybe there is some hope…)

PHARMA/PYSICIANS: United is getting grumpy at the oncology-industrial complex

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While I’ve been focusing on pricking egos in the HBS common room, Greg Pawelski has been keeping vigil on our friends over in the wonderful world of chemo. The main recent development is the FDA issuing a warning about overuse of the anti-anemia drugs Eopgen, Arenesp and Procrit. Amgen (which makes the first two and JVs the latter) is running into problems because of this. Greg believes that things may be worse than that. He wrote to me saying:

Superficially, it sounds like a great expose—greedy clinics/doctors trying to make money by pushing drugs. The New York Times article states that the drugs, given by injection, have been heavily advertised, and there is evidence that they have been overused, in part because oncologists can make money by using more of the drug. That’s not really a new revelation. We’ve been down that road before without much done to change it. According to Dr. John Glaspy, director of UCLA’s Outpatient Oncology Clinic, one complicating factor, experts say, is that oncologists make significant revenue buying cancer drugs from manufacturers and charging patients a higher price for receiving the drugs in their offices. That profit motive could influence some doctors’ decisions. However, patients with anemia, which can cause sluggishness in its early stages and can be fatal in advanced phases, can get blood transfusions, typically every few weeks, instead of using EPO.
 

Could it be that increased numbers of red cells deliver more oxygen to the tumor cells and thereby increase their activity across the board, including with respect to invasion, proliferation, and metastasis? On one hand they’re developing drugs to halt and reverse angiogenesis while on the other hand they’re helping the tumor to obtain more oxygen with existing vasculature. And nobody in charge foresaw that? Amazing how they can apply differing standards for proof or benefit when profit is involved.

Whether or not there’s any truth in that it’s clear that bigger guns than Greg’s are being aimed at the issue. And one such gun belongs to United Healthcare which has found some pretty disquieting things about the use of some big time biotech drugs including Epogen and Herceptin among its cancer patients. Lee Newcomer, United’s ex-Senior Medical Director (but still an employee) told a meeting last week:

In reviewing records of patients who were prescribed the drug erythropoietin — an expensive agent that boosts blood supply in patients with anemia — <snip> 44 percent of those patients had blood work-ups that would indicate they were not anemic. Last year at the NCCN meeting, Newcomer also cited the use of the new breast cancer drug tratuzumab, sold as Herceptin, which has been found to be helpful in a group of women with breast cancer that overexpresses a certain gene known as HER2. The drug is ineffective in women with normal levels of HER2, yet Newcomer said about 12 percent of drug orders — which costs thousands of dollars per treatment — were for women who tested negative for HER2 overexpression.

So right there, real questions abut the inappropriate overuse of the two most popular biotech drugs. But that’s not all. What about overuse of other drugs that may also be innapropriate, but that we’re not so sure about?

Newcomer also said that, when he scrutinized prescribing habits for treatment of patients with pancreatic cancer, "we had doctors writing prescriptions for 188 different combinations of treatments, yet we know that there are only two drugs that have any activity against that disease."

<snip>

Newcomer said that one of the newest biological targeted agents, bevacizumab, sold under the trade name Avastin, which is rapidly being included in numerous drug cocktails because it has been shown to extend survival in diseases such as colon cancer, can cost as much as $47,000 a year for one person. "But that doesn’t explain its true cost," Newcomer said. "We know that Avastin improves outcomes in about 20 percent of patients, but we have no idea which cancer patients will benefit from a course of treatment." According to his calculation, it costs $354,000 per year of life extended with Avastin.

And of course, there’s a message in all this for Pharma and the Oncology-Industrial Complex.

Newcomer and other panelists said that unless the prices of the drugs are controlled, a major backlash against the pharmaceutical industry is brewing.

PHARMA: WSJ’s new blog, NCAA and The Industry Veteran‘s handicapping

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The WSJ has a new health blog. Should be good to keep tabs on—focusing mostly on the business of health care. No posts from Barbara Martinez as yet (pity!). One of their earliest posts is a comparison of March Madness basketball with Pharmabrackets. The Industry Veteran is amused but not too impressed:

The March Madness tournament in NCAA basketball has made millions of office workers with too much time on their hands look at the world through elimination brackets.  I don’t know if this is an improvement over their tendency over the past 20 years to conceive all existence in terms of spreadsheets.  What it has done is taken their parlor trick pastime into some unusual substantive areas.  The other day the Wall Street Journal published elimination brackets showing how they believe Big Pharma will devolve into a Final Four.  It’s amusing, but as with spreadsheets, regression analysis and other idiot-savant endeavors, it shows a thorough detachment from commonsensical reality.

PharmaBracketAny consummation of their elimination pairings runs afoul of some major impediments.1. GSK + AZ.  No way, Jose.  GSK’s biggest product is Advair and AZ is hoping Symbicort will be its second biggest.  A combination would have to axe one of the two.2.  Sanofi-Aventis + Novartis.  Not in this century.  S-A is France’s stake in the ground for a presence in Pharma while Daniel Vasella and his director allies at Novartis are devout Swiss nationalists.  More likely the US of A and France would merge to form one country.3.  Merck + S-P.  Makes sense in that Fred Hassan admits S-P needs pipeline and while S-P can bring marketing acumen to Merck, try getting the latter to admit they need that.4.  Pfizer + Amgen.  Amgen’s stock is down now because of their shenanigans on Aranesp, but as of 12/31 their market cap was just under $80 billion.  Pfizer didn’t do so well with its last megabuy when they acquired Pharmacia for around $60B.  I think Pfizer’s CEO Kindler and CFO Shedlarz would be out on their asses if they tried this.  Besides, Amgen chairman-CEO Kevin Sharer is the new president of Big Pharma’s lobbying group, PhRMA, and he wouldn’t sell his own company while he’s serving as the industry’s figurehead spokesman.

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