My latest from Health Leaders: disparities, quality & TripleAim

by Nora Valdez. Click for more.

by Nora Valdez. Click for more.

Fueled by the financial incentives built into the healthcare reform law, the Institute for Health Improvement’s concept is generating meaningful changes in the way healthcare is delivered, research finds.

Value-based care brings new urgency to the effort to end disparities in healthcare access and outcomes for minorities.

Is female Viagra a scam? Boston women’s health group questions drug, supporters

indexThe non-profits pressuring the FDA to approve a drug billed as female Viagra do not quite make up a top ten list or women’s health advocacy organizations. This health writer has never heard of most of the groups cited in Sunday’s New York Times story.

But familiar women’s health groups, like Boston’s Our Bodies, Ourselves, are siding with the FDA on this one. From their response to an earlier review of the drug.

imagesWomen taking the drug had less than one additional “sexually satisfying event” (orgasm not required) than women taking a placebo. And in the meantime, the drug caused dizziness, nausea and fatigue, particularly with long-term daily use, in some women — hardly the recipe for sexual excitement.

The FDA also considered whether the drug had increased women’s desire — a crucial element of the HSDD diagnosis, which involves low or no sexual interest to the point of distress in people who are physically healthy and not depressed — and found that the drug failed in this area.

The FDA takes another look — and offers  a live webcast of the deliberations —  on Thursday.

In it’s report on the 2010 FDA rejection of the drug, the OBOS  website notes another Bay State-based critic of the drug:

According to Julia Johnson, the panel’s chairwoman and head of the department of obstetrics and gynecology at the University of Massachusetts Medical School, the impact of the drug flibanserin … was “not robust enough to justify the risks.”

More here from another independent, feminist women’s health group, The National Women’s Health Network:

Members of the campaign called “Even the Score” are challenging the FDA on what they claim is a perpetuation of a gender bias by virtue of the claim that the FDA is holding drugs that treat women’s sexual problem to a higher standard than those for erectile dysfunction.  Even the Score has engaged prominent women’s rights organizations, health care providers, the media and members of Congress in a public relations misinformation campaign to criticize the FDA.  There are Female Sexual Dysfunction drugs currently under FDA review, and Even the Score is attempting to move the discussion away from the safety and effectiveness of these drugs and towards controversy about gender bias. 

The reality is that no amount of public relations or slick marketing can get around the fact that the drugs currently being proposed for Female Sexual Dysfunction simply don’t work and may be quite dangerous. Poor efficacy, a strong placebo effect, and valid safety concerns have plagued all of the drugs that have been tested so far. There are many reasons why the proposed drugs may not have been effective in increasing women’s sexual enjoyment; chief among them is the heterogeneity of female sexuality and, of course, research demonstrating that sexual problems are mostly shaped by interpersonal, psychological, and social factors. Nevertheless, pharmaceutical executives will continue to drum up hype over the possibility of a “pink Viagra” because the profit market for this type of drug is estimated to be over $2 billion a year.

Note that neither of these groups accept funding from the pharmaceutical industry. Even the score supporter include Sprout, the company seeking approval for the drug and Trimel Pharmaceuticals, a company testing a nasal testosterone gel for “female orgasmic disorder.”

Yale’s Dr. Ross and the promotion of me-too meds

From ProPublica on me-too meds. Yale’s Dr. Joseph Ross gets a quote in this story. , Vox offers a summary of his NEJM piece on digital marketing to docs. More here on his work into the accuracy of clinical trial registries.

Here’s the NEJM abstract: Pharmaceutical marketing can lead to overdiagnosis, overtreatment, and overuse of medications. Digital advertising creates new pathways for reaching physicians, allowing delivery of marketing messages at the point of care, when clinical decisions are being made.

From ProPublica

Vying for Market Share, Companies Heavily Promote 2018 Me Too’ Drugs

by Charles Ornstein and Ryann Grochowski Jones ProPublica, Jan. 7, 2015, 2 p.m.

propub logoThis story was co-published with the New York Times’ The Upshot.

For more than five decades, the blood thinner Coumadin was the only option for millions of patients at risk for life-threatening blood clots. But now, a furious battle is underway among the makers of three newer competitors for the prescription pads of doctors across the country.

The manufacturers of these drugs 2014 Pradaxa, Xarelto and Eliquis 2014 have been wooing physicians in part by paying for meals, promotional speeches, consulting gigs and educational gifts. In the last five months of 2013, the companies spent nearly $19.4 million on doctors and teaching hospitals, according to ProPublica’s analysis of federal data released last fall.

The information, from a database known as Open Payments, gives the first comprehensive look at how much money drug and device companies have spent working with doctors. What it shows is that the drugs most aggressively promoted to doctors typically aren’t cures or even big medical breakthroughs. Some are top sellers, but most are not.

Instead, they are newer drugs that manufacturers hope will gain a foothold, sometimes after failing to meet Wall Street’s early expectations.

“They may have some unique niche in the market, but they are fairly redundant with other therapies that are already available,” said Dr. Joseph Ross, an associate professor of medicine and public health at Yale University School of Medicine. “Many of these, you could call me-too drugs.”

In almost all cases, older, cheaper products are available to treat the same conditions. Companies typically try to differentiate the new drugs by claiming they are easier to use; carry fewer side effects; work faster than competitors; or have medical advantages.

The makers of Pradaxa, Xarelto and Eliquis, for example, say their drugs are at least as effective as Coumadin for certain conditions but do not require routine blood tests or limitations on what patients can eat. (Patients taking Coumadin, also known as warfarin, shouldn’t eat grapefruit or cranberries and have to limit green leafy vegetables in their diet.)

Officials at the Centers for Medicare and Medicaid Services, which administers Open Payments, and the Pharmaceutical Research and Manufacturers of America, the drug industry trade group, said they had not analyzed the data in order to rank spending by drug.

When told of ProPublica’s analysis, John Murphy, PhRMA’s assistant general counsel, said drug makers’ spending should be seen not only as a marketing strategy, but also as a way of ensuring the best treatment options for patients. “On paper, a drug may not look like it is monumentally better than another drug, but to an individual patient, it might be,” Mr. Murphy said.

* Note: General Payment figures do not include royalties. Source: Centers for Medicare and Medicaid Services, Food and Drug Administration, ProPublica reporting

According to ProPublica’s analysis, Victoza, a diabetes medication made by Novo Nordisk, was the drug associated with the most payments to doctors, by dollar amount. The company spent more than $9 million on physician interactions related to Victoza in the last five months of 2013, excluding research payments and royalties, which relate more to drug development than marketing. (ProPublica created a tool that lets you look up any drug, device or company and compare it with any other.)

Victoza, through a once-a-day injection, helps lower blood sugar among diabetics, but researchers and advocacy groups have said drugs of its class carry an increased risk of thyroid cancer and pancreatitis. Dr. Todd Hobbs, chief medical officer of Novo Nordisk in North America, said the company’s spending reflected Victoza’s newness and the need to address such safety concerns.

“We just received a huge amount of interest and questions and need for education,” Hobbs said, referring to inquiries by health care professionals, particularly primary care doctors. “You see the fruits of that in this report.”

Eliquis, the anticoagulant jointly marketed by Bristol-Myers Squibb and Pfizer, ranked second in its link to spending on physicians, with nearly $8 million, our analysis showed. In a statement, the companies said their spending helps ensure physicians understand the appropriate use of Eliquis. Because the drug is prescribed by physicians in different specialties, the statement said, “it is critical to have a speaker program that adequately provides robust education to these physicians.”

The drug associated with the third-most payments to doctors was Brilinta, a different type of blood thinner made by AstraZeneca that vies for sales with Plavix, which is now available generically. In an email, AstraZeneca said it had identified Brilinta as one of its “key platforms for growth” and increased speaker and research spending on it. “Physicians are also indispensable partners in our efforts to bring new medicines to patients,” the company said.

ProPublica has tracked drug companies’ payments to doctors since 2009 through a searchable database called Dollars for Docs. But this covers only 17 companies, most of which have been compelled to release this information under legal settlements with the government. It has no information from medical device makers.

The list of most promoted drugs featured many recent arrivals: 14 of the top 20 were approved by the Food and Drug Administration since 2010. Some treat similar conditions, including diabetes, schizophrenia and chronic obstructive pulmonary disease, so the competition among them is fierce. “They’re fighting over the same doctors, I guarantee you,” said Rhonda Greenapple Simoff, founder of a consulting firm that advises pharmaceutical companies in Bernardsville, N.J.

Largely absent from the top of the list were drugs that cure disease, such as a new class of hepatitis C treatments, or those that significantly extend life, particularly for cancer patients. If a drug is either the first to treat a disease or is much better than existing drugs, said Dr. Sidney Wolfe, the founder and now senior adviser to Public Citizen’s Health Research Group, “they ‘sell themselves’ on the merits of their unique benefits.”

According to ProPublica’s analysis, a few of the most heavily promoted drugs, including Samsca, which treats low sodium levels in the blood, have serious side effects that came to light after their approval by the federal government. The manufacturers of several others, including Copaxone, Latuda, Xarelto, Daliresp and Humira, have been faulted by the F.D.A. for improper promotion.

Subsys, approved in 2012 to treat cancer pain, ranked 23rd in spending on doctors. It’s often prescribed for off-label, or unapproved, uses; in November, The New York Times reported that some of the doctors paid the most to promote the drug had disciplinary or legal troubles. In a statement to The Times, Insys Therapeutics, the drug’s maker, said its marketing of Subsys was appropriate.

The medical device associated with the most payments to doctors was Intuitive Surgical’s da Vinci surgical robot system, which the company has marketed as an effective, less invasive option for an array of procedures. Critics have complained that the device is needlessly expensive and overused, and say it has been linked to patient complications and deaths.

Intuitive spent nearly $12.8 million on physician interactions to promote the robot in the last five months of 2013, not including royalties and research. The spokeswoman Paige Bischoff said in an email that about half of the company’s outlays for education and training were “pass through” spending: Surgeons or hospitals paid the company for services, and the company, in turn, paid doctors to provide them.

Dr. Robert Takla, an emergency room physician in the Detroit area, earned about $75,000 in the last five months of 2013 by delivering promotional talks about several of the most heavily marketed anticoagulants and blood thinners, particularly Brilinta, according to Open Payments.

He said he enjoys speaking on behalf of companies and thinks he offers a different perspective than cardiologists and internists 2014 the usual prescribers of the drugs 2014 because he treats complications of blood clots in the emergency room.

Dr. Takla said he reviews clinical studies before deciding to speak for a drug and turns companies down when he isn’t impressed. He said he no longer spoke on behalf of Pradaxa because of what he characterized as public backlash against it, driven by a spate of lawsuits against its manufacturer, Boehringer-Ingelheim. (The company agreed to pay $650 million last year to settle the suits.) He accepts fees to speak about Xarelto, a drug he has taken himself for a deep vein thrombosis.

“It’s a very fertile and very robust marketplace right now,” he said of the anticoagulants.

News applications developer Mike Tigas contributed to this report.

Methodology: How we calculated company payments to doctors

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Overdiagnosis or overtreatment? Move to lung cancer screening fuels debate

A report from HLM on Siemens-sponsored, Atlantic-hosted event on “The Diagnostic Debate.”

Gregory Sorensen, the CEO of Siemens Healthcare North America opened the session by challenging the notion that screening drives overdiagnosis.

“We’re not over diagnosing,” he said. “We’re over treating.”

Sorensen used as an example, mammography. When doctors find a “low-grade” tumor like DCIS (ductal carcinoma in situ), they may resort to a lumpectomy or chemotherapy despite questions about the efficacy of those treatments, he explained.

“This in turn leads us to question the value the mammography, because it leads to overtreatment. It is not the mammogram that’s the problem,” Sorensen asserted. “It’s the [healthcare] system’s lack of discipline.”

Atlantic’s event site. 

 

Former NEJM editor Arnold Relman dies at 91

RelmanSee Storify for updates. 

Arnold Relman, the former New England Journal of Medicine editor, has died. From Bryan Marquard at the Globe: 

Eloquent and forceful on the page or the podium, Dr. Arnold Relman led the New England Journal of Medicine for more than 13 years, raising a sometimes lonely voice to warn about the dangers of for-profit medicine when many in politics and his profession raced to embrace a free market approach.

Dr. Relman also was one of the nation’s foremost writers about the rising cost of health care. Persistent to the end, he received the galleys of his final article just a few days before he died of cancer in his Cambridge home early Tuesday, on his 91st birthday.

 

When he suffered a catastrophic fall last year, he wrote about it in The New York Review of Books:

 

Since then, I have made an astonishing recovery, in the course of which I learned how it feels to be a helpless patient close to death. I also learned some things about the US medical care system that I had never fully appreciated, even though this is a subject that I have studied and written about for many years.

 

What he reported was not flattering to Spaulding Rehab, the hospitals that has won praise for working with so many marathon bombing survivors.

What did this experience teach me about the current state of medical care in the US? Quite a lot, as it turns out. I always knew that the treatment of the critically ill in our best teaching hospitals was excellent. That was certainly confirmed by the life-saving treatment I received in the Massachusetts General emergency room. Physicians there simply refused to let me die (try as hard as I might). But what I hadn’t appreciated was the extent to which, when there is no emergency, new technologies and electronic record-keeping affect how doctors do their work. Attention to the masses of data generated by laboratory and imaging studies has shifted their focus away from the patient. Doctors now spend more time with their computers than at the bedside. That seemed true at both the ICU and Spaulding. Reading the physicians’ notes in the MGHand Spaulding records, I found only a few brief descriptions of how I felt or looked, but there were copious reports of the data from tests and monitoring devices. Conversations with my physicians were infrequent, brief, and hardly ever reported.

What personal care hospitalized patients now get is mostly from nurses. In the MGHICU the nursing care was superb; at Spaulding it was inconsistent. I had never before understood how much good nursing care contributes to patients’ safety and comfort, especially when they are very sick or disabled. This is a lesson all physicians and hospital administrators should learn. When nursing is not optimal, patient care is never good.

More on that piece from The NYTimes. 

 

Relman often commented on the influence of money on medicine. In 20o9,  he crashed the inaugural meeting of the Association of Clinical Researchers and Educators (ACRE) “an organization of medical professionals dedicated to the advancement of patient care through productive collaboration with industry and its counterparts.”

So, we asked for his thoughts about the presentations. Here they are:

“I sat through the whole program, which was a sustained diatribe against conflict-of-interest regulations rather than a scholarly, balanced discussion of the issues. There was practically no time for audience questions or comments, but instead an almost unrelenting barrage of ideological and anecdotal criticism of what was said to be a misguided “belief system” that worries excessively over relations between industry and the medical profession. There was an occasional informative and reasonable contribution, but for the most part sarcasm and anger prevailed.
 
The heavily industry-related audience loved the performance, but the obviously biased, self-serving, and often grossly flawed presentations should have embarrassed the organizers. Although neither Harvard Medical School nor the Brigham & Women’s Hospital sponsored or formally endorsed the meeting, the HMS Dean did give the initial welcoming remarks, and the Hospital offered its facilities for the event. One can only hope that they are now having second thoughts.”
More here:

Asking advertisers, journalists and politicians to back up claims #evidence #askforevidence

ssA class at Emerson is working to bring the UK’s “Ask for Evidence” program to the US. The program was highlighted last night at Cambridge Science Festival. (TR was on one of the panels)

The premise behind this project is simple: if politicians, companies, or commentators want us to vote for them, buy their products, or believe their claims, then we should take an active role as responsible citizens and consumers in asking for relevant evidence. This campaign seeks to involve the public, YOU, in your own defense against deceit, by encouraging you to question and investigate marketing, media, or policy assertions that you read or hear. At Emerson College, this project is being incorporated into various Marketing and Communication Sciences and Disorders courses in order to engage students in asking for evidence and to collect data on consumer awareness.

Check it out. 

 

 

Health Leaders Media: What hospitals learned from the Boston Marathon Bombing

From Health Leaders Media

A year after the two bombs went off near the finish line of the Boston Marathon, killing three and injuring scores, the city is making final preparations for the 2014 marathon on Monday, April 21. 

First responders and healthcare workers in particular have learned a number of lessons from the events of April 15, 2013. For example, since the bombing, Boston hospitals have changed the way they receive unidentified trauma patients in the emergency department. Members of the city’s police force are now equipped with military-quality tourniquets.

More lessons, perhaps further-reaching, will come as researchers begin to analyze data on the injuries, surgeries, and outcomes for each of the more than 240 people injured.

Dr King’s Marathon from Tinker Ready on Vimeo.

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