Lester Crawford’s incredibly undistinguished tenure at the FDA ended in weird pseudo disgrace. on the other hand these guys think that his fate could have been much worse.
A major Canadian paper is saying something rather sensible–"War on drugs a loser".
We haven’t spent much time over here talking about the “buckets of cash” scandal that’s been keeping the pharma-focused bloggers very busy, and even less comment on the apparently expensive and rather bizarre purchase of MedImmune. Both concerning AstraZeneca. But The Industry Veteran has been wondering around on the grassy knoll and has come up with a very interesting explanation that links the two:
I spent a good part of the past two weeks in the unaccustomed position of defending AstraZeneca. Equity analysts and others in the pharmaceutical industry seemed astonished by the high price the company paid (a 52 P/E ratio) to acquire MedImmune. Their basic criticism amounts to a complaint that AZ acquired neither an auspicious, late-stage pipeline or a significant cash flow. Both observations are correct but AZ gained other benefits for this steep price. What AZ bought was a place for themselves in two businesses when they acquired MedImmune. Companies typically have to overpay when they want to get into a new game. Ten years ago Abbott paid 40 times earnings when they bought MediSense to get into the blood glucose monitoring business. More recently Novartis paid through the nose to belly up to the vaccine business bar. A few weeks ago Schering-Plough overpaid to buy Organon but Fred Hassan gained stronger positions for himself in the women’s health and the dermatology businesses. Given the current trough in Pharma’s new product development, it’s simply a fact of life that anyone seeking to consummate a merger or acquisition must be prepared to overpay. Fifteen billion dollars for MedImmune is certainly no more outrageous than paying a 42-year old pitcher $15 million for half a season.AZ placed a toe in the water of the vaccine business, something that does not resemble Pharma’s traditional goldmine because a high proportion of vaccine customers are public agencies. Nevertheless, the vaccine business is poised to grow, and if it receives a boost from a pandemic flu epidemic, it will grow enormously. It will also grow substantially if someone makes good on the effort to develop an oncology vaccine or immunizations for the many viral infections that threaten the length and quality of life.In buying MedImmune AZ also acquired capabilities for entering the biologicals business. At this point the multi-billion dollar products of companies such as Amgen and Genentech do not face the precipitous revenue losses that occur when Pharma companies lose patent protection on their products. This is because most regulatory agencies have not developed guidelines for determining acceptable thresholds to approve generic versions of biological products. Congressional waterboys for the biotechs, such as Sen. Ted Kennedy, want makers of generic biologicals to conduct the same sort of clinical trials for their products as the original developers of the branded biologicals. Faced with such high development costs, the generic model of low cost equivalents becomes unsustainable. Nevertheless, despite the disingenuous concerns of Sen. Kennedy and others, Congressmen wise to Pharma such as Henry Waxman and Bernie Sanders will eventually succeed in creating some form of "bio similar" legislation. The country can only tolerate so many stories about people who died because they were unable to make even the co-payments on biological medications costing between $40,000 and $200,000 per year. At that point there will be a major demand for an entire industry of generic biologicals.During the two weeks I was defending AstraZeneca’s purchase, CEO David Brennan and John Patterson, the VP for Clinical Development, did their best to undermine my claims about their wise purchase.
The NY Times shows that apparently doctors owning ESRD centers and others running chemo-infusions centers reap millions for Anemia drugs .
Who knew? OK, anyone reading THCB for the past few years knows all about this, but now that it’s hitting the NY Times (which got a former clinic director to open his version of the books showing that docs in a 6 person group made about $450K a year each on their sale of the drugs) and now that hearings have already been held, and the FDA’s issued a warning, perhaps something may change…
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.’ ”
“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
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.
Fard Johnmar at Envision Solutions has another report out. This one is about the public’s view of disease specific non-profits, such as the American Diabetes, Heart, Cancer, et al Associations/Societies and their alliances with drug companies. Neither side looks too good. To learn more head over to the Spotlight on Pharma-Non-Profit Cause Alliances.
It’s Friday and I’m up over at Spot-on with a rather too hopefully titled piece called, Is the drug war nearing an end?. Come back here to comment.
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.
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…)