A closer look at the downside of the Vertex – Cystic Fibrosis Foundation deal

And some comments from the Knight Science Journalism Tracker: 

A new cystic fibrosis drug–the first to be developed based on understanding of the genetics of the illness–is an orphan drug that can help only about 4 percent of patients with cystic fibrosis. Its financial toxicity is such that it can destroy the finances of those whose lives it saves: It costs $307,000 per year. And it sits in the center of a swarm of conflicting interests involving a pharmaceutical company, a non-profit patients’ organization, and researchers who have taken their money

This comes from John Fauber of the Milwaukee Journal-Sentinel, whodescribes a disturbing case 

VertexLogoSOP

Click here for the MJS story:

What happens when a disease-fighting charity dives into venture capitalism?

In the first case of its kind, the results include one of the planet’s most expensive pills, huge sales projections for a drug company and windfalls for executives who sold stock in the glow of enthusiastic news releases abo

ut the drug.

downloadKalydeco is a breakthrough drug designed from knowledge of the genetic roots of cystic fibrosis, a lung disease that kills most victims before they reach middle age. Developed by Vertex Pharmaceuticals with a $75 million investment from the Cystic Fibrosis Foundation, it is an early example of “venture philanthropy,” where a nonprofit helps finance development of a treatment in return for a cut of sales.


Yet it costs each patient $307,000 a year to take two Kalydeco pills a day – a price borne by taxpayers through Medicaid and other government programs and by the workers and companies who finance employee health insurance plans.
Much of the initial science behind Kalydeco involved nonprofit research universities and hospitals, with funding from the Cystic Fibrosis Foundation and by taxpayers through the National Institutes of Health.

In 2012, with less than a full-year on the market, Vertex sold $172 million worth of Kalydeco and the foundation cashed in by selling future royalties from the drug to an undisclosed firm for $150 million. The foundation is investing that money with Vertex and other companies to develop more new drugs.

For more on the links between patient advocacy groups and drug companies, see TR’s  2006 Washington Post story:

Some groups’ Web sites feature the names of their corporate donors, but often these names appear only in an annual report. Exact donation amounts are rarely listed, though some groups are willing to provide numbers on request.

People who look to these groups for independent information may never learn about their financial ties to drug makers. That needs to change, say some consumer advocates, now that nonprofits are playing a larger role in drug safety debates. When disease advocacy groups weigh in on a drug up for review by the FDA’s Drug Safety and Risk Management Advisory Committee, they say, the public may be unaware of potential conflicts of interest.

 

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:

lilly logoAt 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:

bmcLogo1[1]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.

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