Blood Feud

Friday, December 09, 2011

Kathleen Sharp details the bitter war between pharmaceutical giants Amgen and Johnson & Johnson, and their attempts to push a “miracle” drug by using financial kickbacks to doctors, bribes and Medicare fraud, and using patients as guinea pigs. In Blood Feud: The Man Who Blew the Whistle on One of the Deadliest Prescription Drugs Ever she tells the story of Mark Duxbury, a J&J sales rep who became a whistleblower. The case is now unfolding in a federal court.


Kathleen Sharp

Comments [15]

Hey big pharma rep, TLDR.

By their nature summaries leave things out, but generally illustrate the point. That's why they are called summaries.

Clearly, Ms. Sharp is onto something because you put in an enormous effort to discredit her summary.

Fascinating topic!

Dec. 13 2011 05:18 PM
AlternateView from Jersey

Part 4 (final)

Biased, one-sided discussions like this do nothing to add to the collective understanding of complex topics like the health care debate. Mr. Lopate should and must do a better job of ‘pushing back’ against his guests when they say such incendiary things. I am a long time listener. Have been a contributor in the past and am proud to be working on the next generation of life saving/disease altering drugs. I am your neighbor, a tax payer, a family man. I am not a crook. Mr. Lopate would not allow a guest to speak so negatively about ALL (fill-in-the-blank). It does no public service to scare-monger based on half-truths and exaggerations. Ms. Sharp either spoke loosely without regard for the way she could be taken, did extremely poor research on what actually goes on in the industry, or has an inherent bias that she wishes to propagate. Clearly she wants to sell her book.

Words matter. Precision matters. And this particular segment let the listening public down I’m sad to say. Perhaps Mr. Lopate should reach out to the spokes people from Amgen or JnJ or PHARMA – with the litigation on-going I imagine that won’t happen. But the lack of a response doesn’t mean that this one-side, biased report is correct. As one of the reviewers on said of Ms. Sharp’s book – don’t believe everything you read.

Correction to an earlier comment – I believe that the FDA did NOT pull Vioxx, the drug maker Merck voluntarily withdrew. Small companies do NOT increase the risks of drug discovery; in fact statistics show that they INCREASE the flow of new safe and effective drugs to the market.

Dec. 09 2011 11:46 PM
AlternateView from Jersey

Part 3
Ms. Sharp fails to mention that physicians in the United States can use any prescription drug for any purpose they choose. Pharmaceutical companies simply cannot promote off-label; if it turns out that these companies did so, that is illegal. They should and probably will be punished. At the end of the conversation Ms. Sharp makes some sweeping statements about other therapeutic areas and ‘major players’ – instead of challenging this Mr. Lopate asks a question another question about whistle blowers. It was a real missed opportunity.

This is a problem that we have in our modern world – in our rush to process information quickly we come to snap judgments like ‘bankers are evil’ & ‘CEOs are greedy’ & ‘pharma companies and their employees are crooks.’ These bumper stickers do us no good. They don’t adequately differentiate the immoral and illegal acts of a few, who are in fact greedy criminals. So that is where the law comes in. If folks have done illegal acts they should pay the price. Companies who break the law should pay fines, and the pharma industry is littered with examples of such. But these reps are NOT off the hook because they were given orders to break the law, or break the pharma code, or act immorally. They should have known better at the time.

For Ms. Sharp’s argument to hold together the FDA has to be in the pocket of pharma. Unfortunately, as an industry, we have seen the total annual number of new approvals drop to record low levels over the last few years. We’ve done okay in 2011 but the FDA is hardly overtly kind to the industry. We struggle to understand each other and mistakes are made on both sides - the FDA regulators do a pretty good (if perhaps conservative job) and the industry tries to innovate (as best we can, some notable exclusions granted). The relationship is NOT cozy – not even close. The best and most respected regulatory people in the industry have many scars from battles with the FDA. The FDA’s mission is to approve drugs that provide more benefits than harm to patients – and since EPO hasn’t been pulled it appears that, when used correctly, it probably does just that.

Dec. 09 2011 11:43 PM
AlternateView from Jersey

Part 2

Min 12 – again Ms. Sharp – “the poor patients are stuck with the highest price”
This is a very curious statement from many perspectives. First, around 60% of Americans have some form of health insurance. Insurance covers these individuals’ bills. If anybody gets stuck with the bill it’s the employers (and people who work for themselves) who have seen their premiums go through the roof in recent years. It is true that the 5% of Americans who pay for their health care out of pocket (who have money but not insurance) pay the highest prices and see none of the discounts offered to pharmacy benefit managers, health plans, and wholesalers – but how different is this from the fact that I pay a considerably higher amount for a computer versus a large employer with buying power? Our system creates perverse incentives and there aren’t enough financial incentives to stay fit (or much better financial costs to making costly medical decisions that we all have to pay for…a completely different discussion for sure!). But it’s simply not correct to talk about how patients get stuck with the bill when very few of the patients treated with EPO paid out of pocket. (note - this was before huge co-insurance was implemented on such expensive agents).

A bit later Ms. Sharp starts talking about Reps running mini clinical trials. This is completely, 100% unethical and has been specifically called out in EVERY training (estimated at well over FOUR dozen) that I’ve done since 1997. Given the timing, it IS possible that the Pharma code changed as a result of the actions taken by Amgen and JnJ during the early portion of the timeframe mentioned in the discussion (around 1995). What is much more likely is that these actions were blatantly illegal and that the representatives themselves knew as much. Further the physicians who engaged in these ‘fake trials’ were no less at fault than the representatives. They should have constructed legitimate clinical endeavors and legitimate data collection tools. After all they take an oath to ‘do no harm’ and this includes clinical trials.

During one question Mr. Lopate asks “didn’t they (the doctors) notice?” (that bad things were happening to patients. Ms. Sharp answers “no they didn’t notice” – while this IS possible it is unlikely. The book, The Death of Marco Pantani: A Biography by Matt Rendell describes in detail the types of doping that were performed in European cycling using Epo. In the book he states that various physicians and laboratories, especially in Italy but also broadly across Europe, knew exactly what Epo could do in massive doses. Suggesting that physicians were clueless about the (good and bad depending on your perspective) effects of massive doses of Epo is complete fantasy.

Dec. 09 2011 11:31 PM
AlternateView from Jersey

I listen to a lot of WNYC and am generally very pleased with the professionalism of the reporting, questioning, and journalism. Today I was extremely disappointed by both Ms. Sharp's extremely biased comments and Mr. Lopate's failure to follow up on some of her more outrageous claims.

First the disclosure - I work currently and have worked for over 15 years in the pharmaceutical industry. I am proud of my service and have worked inside various small to large pharma organizations. I have provided consulting services to countless more. I have taken extensive ethics training classes and have served as a sales rep in the field (1997 to 2000). Especially considering the concentration of professionals making their living directly or indirectly from the biotech and pharma industries in this area, I was appalled that OUR community public radio station went along with such potentially dangerous and factually incorrect statements, without so much as a challenging follow up question.

A second disclosure – I have never worked for either of the companies in question, though I did consult for AMGEN years ago in a completely different area of the company. My comments do not preclude the fact that individuals at these companies could have broken the law, violated various codes of conduct, and/or made huge ethical errors. It is well known within the industry that this area was indeed a heated area of competition and it would make sense that some ventured from grey into the blatantly wrong….

We’ve been asked to be brief here so I will limit my comments – a few of the more outrageous or incorrect statements include:
“JnJ increased the dose” – technically a manufacturer cannot ‘increase the dose’ – only the FDA has the power to regulate officially approved promotion of drugs in the US. Physicians can USE products however they see fit. Companies can’t PROMOTE products off label and that’s why you see the fines that you do. JnJ could have concluded clinical trials and applied for a label change via the FDA, but they can’t arbitrarily increase the dose nor could they promote an off-label use or indication.

Min 10 – regarding the physicians working for only one company Ms. Sharp said “they didn’t (work for) the two companies at the same time.”
It is illegal for a pharma company to lock up a doctor, whether that doctor is a prescriber, speaker, or clinical participant. It is much more likely that these ‘thought leaders’ worked for BOTH companies at the same time. Alternatively, since the indications did not overlap from a specialist perspective it is possible that certain docs never worked for both companies, but that has more to do with the promoted labels than anything else. My concern here is the inference that drug companies can ‘own’ a doctor, which is ludicrous.
In the same exchange she mentions outrageous trips and spouses coming to dinners – this WAS possible before but the Pharma code has been updated however these activities are no longer permitted.

Dec. 09 2011 11:22 PM
groovey from NYNY

I took procrit for about 7 months IV once a week to offset low blood cell count druring ribovirin and pegalated interferon treatments for hep C. I relapsed on the Hep c and now I am about to try a triple therapy with broprovir and peg/ribo. I have no problem taking procrit to offset low bloodcell count. I pated close attention to my blood values and the procrit helped with the anemia

Dec. 09 2011 05:49 PM
Anthony Drago from Jackson Heights, NYC

To a layman like myself, the claim that Epogen or Procrit is a "deadly drug" was not convincingly made, in my opinion. The danger of epo (stroke and heart attacks were mentioned) seems correlated to dosage. My impression after listening to Ms. Sharp was that the drug is effective and safe as a treatment for anemia at a low or moderate dosage and becomes deadly only when the dosage is upped to an inappropriately high level. But what is a high or low dosage of epo? Ms. Sharp didn't specify, except to mention, at one point, a 33% upping of the dosage, a figure which means nothing to me without a reference point. Some precise information about dosage should have been included for listeners like me who have a family member who were given either of these two drugs automatically during dialysis treatment. I believe that patients at this facility have no choice. As far as I know, this is still the practice. Does Ms. Sharp believe this practice of incorporating the drug (no matter the dosage) into the dialysis process is dangerous and should be stopped?

Dec. 09 2011 01:34 PM
Lucky from NYC from NYC

I am blown a way and grateful. I am a cancer survivor who was given procrit. I was trained to self inject it, once per week. Chemo was hard on me and Procrit was supposed to give me energy to get through the day. It wasn't very helpful. Eventually, I went into remission and treatment stopped.

I hadn't heard about this deadly drug until today, on npr. I am in shock and wonder if the cancer that did come back to haunt me is a partial result of procrit.

Dec. 09 2011 12:41 PM
Anne from New York

Why is this drug still on the market... one of the contraindications is "increased mortality"!?

Dec. 09 2011 12:38 PM

I'd say that Mr. Lopate is wrong on the differences between Bush and Obama. On whistleblowing, Obama is _more_ conservative than Bush. On oversight of corporations, he is pretty much indistinguishable. Worse, Obama has shown no inclination whatsoever to stand up to opposition of any kind.

Dec. 09 2011 12:36 PM
nh from NYC

I m pretty sure my late mother (deceased in 2003) took Procrit during Chemo.

Is there a class action lawsuit or other action on behalf of patients?

Dec. 09 2011 12:33 PM

It should be noted that Obama has carried on a war against government whistleblowers that exceeds even George W. Bush.

Dec. 09 2011 12:29 PM
ben from Brooklyn

Wondering if this drug would have been used as part of treatment for HIV?

Dec. 09 2011 12:16 PM
mitchell essig md

You should have mentioned the book "the 800 million dollar pill " . The beginning of this book profiles the developement of epo
by the drug companies . Who benefitted & who got ondercut by its patented developement .

Dec. 09 2011 12:16 PM
rh from NYC area

I am very conflicted on these issues. I'm on Levaquin right now, which was almost pulled due to tendon rupture as a potential side effect. I've been on it multiple times since it was almost pulled, and it has been crucial to my good health - no tendon side effects so far. I cannot take many other antibiotics, so my options would be minimal (IV antibiotics maybe) if I could not take Levaquin.

Same thing with Vioxx - I have friends who felt it was a life-saver for them. I think the problem is that we all accept risks in exchange for benefits. In the case of Vioxx, it did work better for some people, but others would not take the risk. But the FDA took away the choice.

The problem is that the companies have a ratio of 1,000,000 prospect compounds:100 possible drugs:10 drugs to animal trials:1 drug to human trials. The amount of time, and the number of drugs "thrown away" for one drug that gets through to human trials is enormous. The key is that we have to improve our computational and cell-based screening of these compounds to get the dangerous ones thrown out early. The involvement of smaller companies in drug discovery is only making this worse.

Dec. 09 2011 10:49 AM

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