Will competition in Hep C drug market bring down costs? #hepatitis

Lots of health news emerges from investor events like this week’s J.P. Morgan Healthcare Conference. The Globe’s Robert Weisman reports this morning on competition for Cambridge-based (soon to be Boston-based) Vertex Pharmaceuticals.

SAN FRANCISCO – It was supposed to be a victory lap for Vertex Pharmaceuticals Inc. executives: their first appearance at the life sciences industry’s most important annual conclave since the Cambridge biotechnology company won long-sought approval of its potential blockbuster drug to treat hepatitis C.

But the Vertex team, including the departing chief executive and his newly appointed successor, was partly upstaged by an announcement on the eve of the 30th annual J.P. Morgan Healthcare Conference that the giant drug maker Bristol-Myers Squibb Co. was entering the hepatitis C market.

Bristol-Myers said it will spend $2.5 billion to buy Inhibitex Inc., which is developing a next-generation hepatitis C treatment that will compete with two being developed by Vertex.

As he notes, the company’s stock price has dropped from $58.87 in May to $35.68 yesterday.

Will competition also bring the price of Telaprevir down?  The Globe reports that the drug will cost between $30,000 and $50,000 per treatment.

In the meantime, the company is building a new waterfron tower.The Globe also reports that the new headquarters will cost $2 billion. Boston will kick in a $11.8 million tax break, for the company, which is now located in Cambridge.

Radio Boston: The Influence of Pharma on Docs

WBUR’s Radio Boston takes on the ever-present issue of the influence of drug makers on docs. Listen on their web site or today at 3. Guests include:

Jerry Avorn, M.D., PChief of the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital and author of Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs.

Leslie Jackowski, M.B.B.S. (M.D.), Exeuctive Director for Program at the ALOSA Foundation a nonprofit organization “dedicated to the dissemination of accurate, unbiased, evidence-based and non-commercial information about medications for health care professionals and patients by providing educational services (interactive outreach to physicians, classes, presentations, seminars, conferences) about the development, regulation, risks, and benefits of prescription drugs.” In other words, they come in after the drug companies pitch their drugs and give other docs more objective information about meds.  The scientific jargon for this is “counter-detailing,’ a reference to the term “detail man” used to describe drug reps who do direct sales to docs. That term is no longer relevant, especially since many detail men are now young, attractive women.

Thomas P. Stossel, M.D.,  American Cancer Society Professor of Medicine atHarvard Medical School, Director of the Translational Medicine Division at Brigham & Women’s Hospital, Founder of the Association of Clinical Researchers and Educators. For more on ACRE, see the BHN report on the group’s inaugural meeting, as well as a comment from former NEJM editor Arnold Relman. (Brother John Stossel, a crusading TV journalist who often takes on what he describes as “junk science,” just made the leap from ABC to Fox. )

Georgia Maheras,  Esq., Private Market Policy Manager at Health Care for All

Partners limits questionable moonlighting for docs

The New York Times reports:

Senior officials at the two hospitals, Massachusetts General and Brigham and Women’s Hospitals in Boston, must limit their pay for serving as outside directors to what the policy calls “a level befitting an academic role” — no more than $5,000 a day for actual work for the board. Some had been receiving more than $200,000 a year. Also, they may no longer accept stock.

Criticism has been mounting in recent years as the conflicting roles of some medical leaders have been disclosed through Congressional investigations, lawsuits and reports in the news media. Those disclosures have raised questions about bias and the cost and quality of patient care at the nation’s medical institutions.

enior faculty in leading teaching hospitals are in high demand on medical product boards, but corporate filings show that Partners and Harvard Medical have a disproportionate share.

The story points out that Dr. Samuel O. Thier was president of Partners when he was named to the Merck board in 1994. He is now retired from Partners.

Dr. Joseph B. Martin, dean of the Harvard Medical School from 1997 to 2007, was named to the board for Baxter International in 2002. Dr. Thier and Dr. Martin each receive over $200,000 a year from the corporate boards.

Dr. Martin, a professor of neurobiology, declined to comment. Dr. Thier did not return calls seeking comment.

For more on medical conflict of interest and research integrity, click here.

Lilly funds 60 Boston docs

From The Boston Globe:

At least 60 Massachusetts doctors collectively have earned more than a half-million dollars this year as speakers paid by pharmaceutical giant Eli Lilly & Co. – including two Boston Medical Center physicians whose participation is being reviewed for possible violation of a hospital policy against marketing activities by its doctors.

After learning of the doctors’ company-sponsored talks from the Globe, Boston Medical Center said it would investigate the matter and directed the physicians not to make any further presentations on behalf of Lilly in the meantime.

So much for internal disclosure. More from the Globe:

The use of physicians in speakers programs or “bureaus’’ like Lilly’s, in which doctors generally use company-prepared materials to explain a drug’s uses and dosing to their colleagues, is widespread in the drug industry. But the practice is under growing scrutiny and some academic medical centers are barring their doctors from participating, believing that physicians essentially become hired advertising guns, with weakened credibility.

10/1 update  The Wall Street Journal reports on new industry authorship guidelines from PHRMA.

 Here are a few interesting details, followed by a big grain of salt:… The guidelines are purely voluntary.

Also see today’s Globe editorial and letters both for and against industry support.

 WCVB Channel 5 in Boston also reports.

 Health reformers at Boston’s Health Care for All commented on their blog. So did Gooz News. 

 Here’s the Lilly list of company funded docs.

 Note that Lilly was not a big supporter of the state’s ban on pharma junkets for docs. From the Boston Business Journal.

 The head of pharmaceutical giant Eli Lilly & Co. on Friday blasted a new law governing how drug companies market to physicians, calling it a bad move that will hamper innovation and force companies to reconsider expanding in Massachusetts.

Still, it didn’t stop the biotech industry from planning their annual meeting here — for the second time in three years — as announced yesterday.

For more on critics of pharma sponsorship of doctors, see the Integrity in Science Project.   

For more on docs who want to be free to work closely with industry, see the webcasts and slides from July’s inaugural meeting of The Association of Clinical Researchers and Educators (ACRE) an “organization of medical professionals who recognize that appropriate physician-industry collaborations and relationships benefit patients and advance science.”  Also note BHN’s reporting from the meeting, which took place at Brigham and Women’s Hospital.   

 At that meeting, Dr. Carey D. Kimmelstiel,head of clinical cardiology at the Tufts University School of Medicine, talked about the benefits of having clinicians give industry-sponsored talks. Preparing the talk educates the speaker. He or she gets feedback and an audience of busy docs gets a quick update. He did say some of the transparency are good because it discourages clinicians from showing company-produced slides without really understanding them.

 But he believes the law has constrained continuing medical education by limiting the “the only reliable source of such funding, which is industry.”  

 Click here for his full statement and all of the presentations at the ACRE meeting.

9/30 The Wall Street Journal reports on new industry authorship guidlelines from PHRMA.

 Here are a few interesting details, followed by a big grain of salt:… The guidelines are purely voluntary.

FDA doc takes heat for strict standards on new cancer drugs

 I had a long wait for the Red Line and a gratis NY Times from the BU Comm school. So, I read this piece about the FDA doc who is trying to protect patients from marginally useful cancer drugs.

Dr. Richard Pazdur, director of the Food and Drug Administration’s cancer drug office “has helped to loosen approval standards for cancer medicines and made it easier for dying patients to get experimental drugs. But he demands that drug makers prove with near certainty that their products are beneficial…Some, say this has “has cost thousands of lives and set back the pace of discoveries….”

Dr. Bruce A. Chabner, clinical director of the Massachusetts General Hospital Cancer Center was quoted in the story:

“…(S)ome cancer specialists say that Dr. Pazdur, after pushing for years to lower approval standards, has toughened them recently after being criticized for approving drugs that were later shown to have few benefits.’I’m worried there’s been a change in his thinking that could be adverse for the field,’ (Chabner) said.”

The Times article noted that Chabner is “a member of the board of directors of PharmaMar, a Spanish biotech company whose drug Yondelis is approved in Europe but was rejected in July by the F.D.A.’s cancer advisory board after a critical introduction by Dr. Pazdur.”

Others think Pazdur’s approach keeps toxic, high-priced, barely effective drugs off the market.  

He also “has a lot of support within the mainstream cancer community,” said Dr. Otis W. Brawley, chief medical officer of the American Cancer Society. In May, the oncologists’ society gave him a special recognition award for “his outstanding service to the oncology community.”

Wasted meds, inappropriate ‘scripts help fuel health costs

This from a coalitions of drug companies, lawyers, academics and insurers.  See board of directors.

In 2007, the New England Healthcare Institute (NEHI) released a report, “Waste and Inefficiency in the Health Care System,” which estimated that a full third of the $2.4 trillion spent on health care in the U.S. could be eliminated without reducing the quality of care. In its new research brief, “Thinking Outside the Pillbox,” NEHI addresses the root causes of poor patient medication adherence – a significant contributor to overall health care waste – and offers promising solutions to improve adherence, particularly among chronic disease patients.

I thought these folks were taking a “blame the victim” approach, but they seems to want to hold docs accountable too.

The design of a medically appropriate drug regimen for each individual patient is a crucial factor in sustained medication adherence. Medication appropriateness should be considered in the context of all other prescriptions and medical orders to which the patient is subject – not always an easy task when patients have multiple prescriptions written by multiple prescribers. Some experts interviewed by NEHI claim that prescribers could reduce non-adherence to only 10-15 percent simply by getting the correct drug regimen in place.

Harvard muzzles med students

Sept. 11 update — Harvard backs down

Do not even get BHN started on the topic of free speech on campus. Let’s  just say that many thin-skinned universities apply the concept of academic freedom very selectively.

Harvard Medical School is apparently one of them. When doctors-in-training got a copy of their updated student handbook , they were surprised to find this item. From the Globe story:   

“All interactions between students and the media should be coordinated with the Office of the Dean of Students and the Office of Public Affairs. This applies to situations in which students are contacted by the media as well as instances in which students may be seeking publicity about a student-related project or program.’’

Harvard has since removed the policy from its website saying it ”was being misconstrued as an infringement on freedom of speech…” 

Right.

The students say this policy appeared after Harvard members of the American Medical Student Association spoke to The New York Times about the kind of education they were getting from some industry-sponsored profs.  The group graded schools on “the presence or absence of a policy regulating the interactions between their students and faculty and the pharmaceutical and device industries.” Harvard got an F.

 From the NY Times story in question:

 BOSTON— In a first-year pharmacology class at Harvard Medical School, Matt Zerden grew wary as the professor promoted the benefits of cholesterol drugs and seemed to belittle a student who asked about side effects.

 Mr. Zerden later discovered something by searching online that he began sharing with his classmates. The professor was not only a full-time member of the Harvard Medical faculty, but a paid consultant to 10 drug companies, including five makers of cholesterol treatments.

 “I felt really violated,” Mr. Zerden, now a fourth-year student, recently recalled. “Here we have 160 open minds trying to learn the basics in a protected space, and the information he was giving wasn’t as pure as I think it should be.”

 Here’s more on Harvard’s backpedal. From today’s Globe:

After some students complained, the medical school removed the policy from the online student handbook and said it did not intend to interfere with students’ speech.

“We did not back off the guideline, but took it down temporarily because it was being misconstrued as an infringement on freedom of speech – and that was never the intention,’’ Dr. Nancy Oriol, the medical school’s dean of students, said in an e-mail interview. “The next step will be to work with the students to . . . ensure there is clarity of our intent.’’

Fortunately, this policy did not apply to the UConn student I interviewed at a recent conference on the topic

Finally, the Globe also had this unintentionally related wire story today.

WASHINGTON – Federal prosecutors hit Pfizer Inc. with a record-breaking $2.3 billion in fines yesterday and called the world’s largest drug maker a repeating corporate cheat for illegal drug promotions that plied doctors with free golf, massages, and resort junkets.

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My brush with medical ghostwriting

I went to session at a science writers’ meeting a few years back on how to make a six-figure living. The session leader talked about getting  jobs from drug companies to write  review articles. They’ll give you all the medical studies you need. The pay, at the time, was exponentially higher than any other science writing work.

Um.  So, you can’t include any other studies? No. And, a doctor’s name goes on it? Yes.  As I recall, a few people in the room said they made a good living that way. The session then turned into a tense debate about the ethics of this kind of work.

So, when someone pointed out the story in the Times this week about evidence of ghost written scientific articles, I said — old news.

Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known.

Health Reform Gone Wild!

– A story from the NYTimes on a secret White House deal on drug prices. Seems the $80 billion present from the drug makers came with strings attached. Duh.

Drug industry lobbyists reacted with alarm this week to a House health care overhaul measure that would allow the government to negotiate drug prices and demand additional rebates from drug manufacturers.

In response, the industry successfully demanded that the White House explicitly acknowledge for the first time that it had committed to protect drug makers from bearing further costs in the overhaul. The Obama administration had never spelled out the details of the agreement.

photo by caveman92223 via flickr

– Scenes from the health reform shout down. The Globe reports.

 

 

This photo is from a July 17 protest  in  California.

More here

I notice that a lot of the people at these protests look old enough to qualify for Medicare, which is a government-run health program. Seems  not all of them realize this, inspiring a spew of outrage from the Huff Po.

  – If you are interested in a less frothing debate on health reform, check out the Health Wonk Review, a twice monthly digest of intelligent health blog postings. At the very end you’ll find my post on doctors fighting gift bans and conflicts of interest rules.

BHN Exclusive: Mass gift ban takes a beating from ACRE

Thursday’s inaugural meeting of the Association of Clinical Researchers and Educators drew a full house to the Bornstein Amphitheater at Brigham and Women’s Hospital.  Members of the group believe that disclosure rules and gift bans for doctors – like the one that just went into effect in Massachusetts –  are too strict.  The meeting program describes the issue this way:

Under mounting pressure from interest groups, the media, and select government officials, academic medical centers have begun adopting restrictive conflict of interest policies that often sever productive relationships between industry and physicians involved in clinical research and educational outreach.

(See this Globe story for  background on the topic or click on the “research integrity” category to the left. Critics of industry support for academic researchers say it creates to conflicts of interest. Supporters believe it encourages innovation. )

So, with portraits of notable BWH doctors looking down on them, researchers, lawmakers and industry reps made a lot of jokes about the corrupting influence of pens with drug company logos. A sampling of the speakers found that they ranged from measured and informative to shrill and angry.

This from a session on the Massachusetts gift ban, which prohibits drug and device companies from marketing products by courting doctors with high end meals, Red Sox tickets and four-star travel.  

–State Representative Michael J. Rodrigues, vice chairman of the legislature’s Committee on Public Service, said doctors need to be more involved in fighting the laws like the state’s gift ban law.

“I was very happy with the support I got from industry. But throughout the debate I was wondering – where are the physicians. “

–Sarah Elisabeth Curi, a lawyer with the Mass Medical Society, explained the new law and said the law will focus on industry compliance, not doctors.

 “No physician in Massachusetts is going to be arrested for not complying with the law”

Click here for her powerpoint.

–Dr. Carey D. Kimmelstiel, head of clinical cardiology at the Tufts University School of Medicine talked about the benefits of having clinicians give industry-sponsored talks. Preparing the talk educates the speaker. He or she gets feedback and an audience of busy docs gets a quick update.

 Audio:

  Kimmelstiel argues that the rules have tamed some excesses.

 But, he worries they go too far.

 

– Dr. Henry R. Black  Hypertension Division, New York University Medical Center, President, American Society of Hypertension :On Value of Collaboration to Medical Training Programs & Professional Associations

Audio: Part 1, Part 2

There were also a few supporters of conflict rules and gift bans in the crowd, including former NEJM editor Arnold Relman, who offered post meeting comments. The American Medical Student Association– a group worried about conflicts  of interest for industry-funded professors  – also sent a few people. Nitin Roper, a University of Connecticut medical student, had this to say about the meeting.

   

Roper ACRE

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Finally, here are some other reports on ACRE and the meeting: Postscript,  The Carlat Psychiatry Blog and Policy and Medicine