STAT: Is personalized medicine being oversold?

BHN has been all about the Globe this week. Here’s one more, and we’ll take a break.

A welcome story from STAT this morning on the front page of the Globe. It does feel like cancer programs and researchers have been overselling the promise of personalized treatments. Despite dramatic effects for some patients, the approach doesn’t help everyone, as the story notes.

The story includes a comment from the head of the hospital treating the patient. Beyond that, it  does not quote any scientists or clinicians who defend the approach. Would that have introduced what journalists call “false balance?” Or, just both sides of the story?

Bring on the comments.

The return and spread of Moore’s cancer in a form that seems impervious to treatment shows that precision medicine is more complicated than portrayed by politicians and even some top health officials. Contrary to its name, precision medicine is often inexact, which means that for some patients, it will offer false hope rather than a cure.

“There is a paradigm shift in the treatment of cancer as we move to precision medicine,” said Dr. Lincoln Nadauld of Intermountain Healthcare, a large system of hospitals and clinics based in Utah. “But that doesn’t mean the outcomes are going to be perfect in every case.”

The New York Times ran a similar story in 2014 about stem cell therapy. Unlike personalized medicine, few credible providers have started selling it to patients. Cancer centers have been selling personalized medicine for years. Here’s how the approach is promoted:

Cancer Centers of America

How can genomic testing help patients now?

Every cancer is different. Genomic testing helps our doctors understand a patient’s cancer at the molecular level and may reveal more personalized treatment options.

The Mass General Cancer Center’s pitch is more nuanced.

By therapeutically targeting the abnormal protein activity that is specific to the cancer cells, the impact of these drugs on normal cells is dramatically reduced, thereby limiting side effects

 

Looking for Boston Globe health reporting? Try the business section

ssUPDATE: Props to Beta Boston, another source of Globe health reporting.

Since the Globe currently has no full-time health and science editor, no science writer and a hard-to-find, often dated health site, we turn to the business section for news on health, or at least health finance and pharma. Perhaps things will pick up in the fall.

In terms of Globe-ish  health-sci-ish  reporting, we see STAT continuing to pop up in the paper and the paper’s website but not the STAT website. The business section of the print version of today’s paper premieres a weekly column called Kendall Squared. Today, Andrew Joseph reports on the rebranding of the square-less square, the sale of dishes at the closed Hungry Mother restaurant, a Forsyth Institute dentist who runs a children’s clinic in Kuwait and a non-profit dispute resolution group that is being prices out of the Square.

In the meantime, best to follow individual members of the Globe‘s shrinking but solid Metro sci-health team:

Kay Lazar @GlobeKayLazar

Liz Kowalcyk @GlobeLizK

Felice J. Freyer @felicejfreyer

And, check the business page. The state Center for Health Information and Analysis has come out with it’s latest hospital profits report and today, The Globe helps sort it out for us.

The state’s biggest hospitals were the most profitable in 2014, with Massachusetts General Hospital, the largest academic medical center, earning $200 million, up 34 percent from the previous year, and Brigham and Women’s Hospital earning $152 million, up 9 percent. Both are owned by Partners HealthCare of Boston.

Other big earners were Baystate Medical Center of Springfield, Lahey Hospital and Medical Center in Burlington, Saint Vincent Hospital in Worcester, and Beth Israel Deaconess Medical Center in Boston. The results are for fiscal year 2014, which for most hospitals ended last September.

The profits overall, however, mask some of the struggles in the changing field. Quincy Medical Center lost $39 million last year, the most in the state. Its owner, Steward Health Care System, closed the hospital at the end of the year. North Adams Regional Hospital in the Berkshires closed several months earlier. The push to cut costs has, in part, prompted several hospitals to consider mergers or acquisitions.

Earlier this week, the paper reported that the advent of ACOs has cut Medicare spending at five major health systems in the state

New figures show five Massachusetts health systems saved a combined $141 million during that period as part of the program, which aims to rein in costs by better coordinating care for Medicare patients and cutting unnecessary hospital stays and medical services. Doctors manage care for these patients in pools known as Pioneer accountable care organizations.

STAT, The Boston Globes’s national health and science website, tosses us a story

ssWe don’t know if the copy is going to be in the paper or just online, but today, STAT makes its debut — in both formats. The site promises “Reporting from the frontiers of health and medicine We take you inside the science labs and hospitals, biotech boardrooms and political backrooms. We dissect crucial discoveries. We examine controversies and puncture hype. We hold individuals and institutions accountable. We introduce you to the power brokers and personalities who are driving a revolution in human health.

Today’s story –how social media is gumming up clinical trials and riling  up pharma investors. It begins with a story of a woman who posts about being in a clinical trial.

The stock of a Cambridge-based biotech company would rise and fall with her updates. Investors would scrutinize Stracham’s words and pore over individual frames in her videos. Stracham herself would be subjected to uncomfortable questions from strangers: Could she control her bowels? What about her bladder? Was she faking the small gains in movement she chronicled online? Other strangers would help her raisess about $40,000 online to cover her medical bills — and, most unexpectedly, her posts would lead her to love.

This wasn’t the first time a patient had taken to social media, of course. Parents of terminally ill children have staged massive Twitter and Facebook campaigns to demand access to experimental drugs. They’ve rallied online for lower prices and faster approval of new therapies.

But Stracham’s upbeat posts pushed into new territory, raising unsettling questions about the integrity of clinical trials and the power of patients to move the market in the age of social media. “Whoop Whoop moving this process along!!” she wrote in March. “Oh you know just taking some small steps today!” she captioned a video of herself moving with the support of a physical therapist in May.

Don’t expect familiar bylines from the Globe’s strong health and science staff. Stat is separate from the Globe newsroom. The new site spent a few months rounding up health and science staff with impressive resumes. (They’ve already had one employee dust up.)

We wish them well and know they’ll produce much copy for us to share.

A bit more on Stat here from Poynter.

A lot more on patients and social media from Boston’s own PatientsLikeMe:

…(W)e continually enhance our platform, where patients can share and learn from real-world, outcome-based health data. We’ve also centered our business around these values by aligning patient and industry interests through data-sharing partnerships. We work with trusted nonprofit, research and industry Partners who use this health data to improve products, services and care for patients. 

DCIS, female “viagra” and other disturbing women’s health news

Big news in women’s health this week. Good news? Depends on how you see it.

The NYTimes reports that surgery for early stage not-quite breast cancer is pretty much useless. Not shocking since NCI decided that DCIS shouldn’t even be called “cancer.

They say, for instance, that some premalignant conditions, like one that affects the breast called ductal carcinoma in situ, which many doctors agree is not cancer, should be renamed to exclude the word carcinoma so that patients are less frightened and less likely to seek what may be unneeded and potentially harmful treatments that can include the surgical removal of the breast.

Here’s what the editorial on the JAMA study says:

The original goal of mammographic screening was to identify invasive cancers at the earliest stage, because of the superior prognosis of stage I cancers. Prior to the advent of screening, ductal carcinoma in situ (DCIS) made up approximately 3% of breast cancers detected. As we pushed to find smaller and smaller cancers, and targeted calcifications instead of just masses, we began to identify DCIS more frequently. Now DCIS accounts for approximately 20% to 25% of screen-detected breast cancers. The cells that make up DCIS look like invasive cancer both pathologically and molecularly, and therefore the presumption was made that these lesions were the precursors of cancer and that early removal and treatment would reduce cancer incidence and mortality. However, long-term epidemiology studies have demonstrated that the removal of 50 000 to 60 000 DCIS lesions annually has not been accompanied by a reduction in the incidence of invasive breast cancers.1 This is in contrast to the experience with removal of colonic polyps and intraepithelial neoplasia lesions of the cervix, in which the removal of precursor lesions has led to a decrease in the incidence of colon and cervical cancer, respectively.2 We now know that breast cancer encompasses a range of behaviors, from aggressive to indolent; the latter are more likely to surface with screening.3 The analysis of Narod et al4 fuels a growing concern that we should rethink our strategy for the detection and treatment of DCIS.

In this video from Dana Farber, Dr. Eric Winer says doctors need to be clear with patients about the reality of DCIS. “What this is all about is conversations between doctors and patients.” Still, he describes surgery as the standard of care.  Will that change? Despite evidence the lumpectomy is as effective as mastectomy, many women still choose the latter.

Also, the FDA approved so called “female viagra” Here’s the benefit: women taking flibanserin reported between 0.5 and one more sexually satisfying event per month, compared with women taking a placebo.

Here’s what Boston-based  OBOS had to via a guest post on an FDA hearing.earlier this summer.index 

Liz Canner, a filmmaker who produced the documentary, “Orgasm, Inc.,” which examines the search for a female sexual enhancement drug, said the company had “deceived women into taking a drug that doesn’t work better than drinking a glass of wine or two, and could end up killing us.”

“To approve this drug would set the worst kind of precedent: that companies that spend enough money can force the FDA to approve useless and dangerous drugs,” said Dr. Adriane Fugh-Berman of Georgetown University.

More than 30 of those who testified — including health-care providers and a number of women who had participated in the trials — urged the panel to support the drug. One provider stood at the microphone in awkward silence to illustrate how little she has to offer her patients with low sexual desire.

“I want to want my husband, it is that simple,” Amanda Parrish, a mother of four from Nashville, told the panel. “For us, flibanserin is a relationship-saving and life-changing drug.”

Here’s another POV from North Shore psychology blogger Dr. Daniel Carlat;

Flibanserin (brand name Addyi) has just received a controversial and complicated FDA approval for the treatment of low sex drive in women. There’s a lot of outrage in the blogosphere, much of it centered on the lobbying of the FDA by disease advocacy groups.  I agree that this politicization of what should be a scientific process is embarrassing to both Sprout and its supporters. Nonetheless, I’m not nearly as hard on flibanserin as some of my colleagues.

However, the does agree with this statement:

Adriane Fugh Berman said it best as quoted by the New York Times: Flibanserin is a “mediocre aphrodisiac with scary side effects.”
 

Partners Healthcare to open urgent care clinics in Boston suburbs and beyond

The Globe reports that Partners is getting into the the walk-in clinic business, with plans to open three and eventually 12.

Seems this is a new run at the market, which is growing here and elsewhere.

parnerslogoPartners will offer an advantage: unlike many other urgent care centers, it will accept Medicaid, aka Mass Health.

Not that it will have to in towns with uninsured rates like Brookline (1.1 percent),

Newton (1.6 percent) and Watertown (3.8 percent). Per capita income suggests the percent covered by Mass Health will be low as well.

From The Globe:

Urgent care centers cater to patients who have health problems — such as colds, infections, cuts, and fractures — that aren’t serious enough to warrant a visit to the emergency room. Such clinics have been on the rise as more patients, facing long waits for doctor visits and high costs at hospital emergency rooms, seek new options for care

 Partners is late to urgent care. Steward Health Care System, Beth Israel Deaconess Medical Center, Lahey Health, and others also are already in the business, either directly or with partners.

But Partners has advantages in its size and reputation. It is the parent of 10 hospitals, including Massachusetts General and Brigham and Women’s, and has 6,000 doctors, the largest network in the state. It also is planning more urgent care locations than most of its competitors.

My father’s brain is missing  

Not my father's brain

Not my father’s brain

Certain that years of meds, scotch, steak and surliness had gotten to my Mad Men-era dad, we agreed to donate his brain to Harvard. He came up clean – not a trace of damage or plaque.

The findings are actually missing, not the samples.

The Boston Globe reports:

McLean Hospital said Tuesday that information about 12,600 people who donated their brains to research has gone missing. McLean, a psychiatric hospital in Belmont owned by Partners HealthCare, said most of the people affected are deceased. The others are people who have committed to donating their brain tissue to medical research upon their death. Some family members of brain donors also were affected.

The hospital said four backup data tapes at its Harvard Brain Tissue Resource Center went missing on May 29. These tapes contained private information, including names, dates of birth, diagnoses, and some Social Security numbers. The tapes, which are unencrypted, were never found.

Massachusetts thread in NYTimes story on drug price rekoning

The New York Times reports:

As complaints grow about exorbitant drug prices, pharmaceutical companies are coming under pressure toHIT DEST disclose the development costs and profits of those medicines and the rationale for charging what they do.

So-called pharmaceutical cost transparency bills have been introduced in at least six state legislatures in the last year, aiming to make drug companies justify their prices, which are often attributed to high research and development costs.

One of them is Massachusetts. Also,Vertex comes up for the price of its CF drug — see recent post .

Finally, Tufts Center for the Study of Drug Development takes a knock for its oft-cited development cost reports.

Pharmaceutical executives do not typically tie the price of any particular drug to its development cost. But they do say that their sales have to recoup their investment in research and development if the companies are to stay in business.

They often cite the Tufts Center for the Study of Drug Development at Tufts University, which last year said companies spent an average of $2.6 billion to bring a drug to market, up from an estimate of $800 million in 2003. That includes the cost of failures. And almost half the figure is opportunity cost, the amount a company might have earned if it had invested money elsewhere rather than spending it on drug development.

Critics are skeptical of that figure, saying that the Tufts center gets funding from the pharmaceutical industry and uses data supplied by the drug companies, but does not disclose which drugs are used as the basis of the estimates.

Here’s what Tufts has to say about that:

Our Approach to Research

The Tufts Center for the Study of Drug Development (Tufts CSDD) conducts its research by working closely with government regulatory authorities and with drug developers and manufacturers of all sizes in the U.S. and abroad. Data are collected from the people who create it — pharmaceutical and biotechnology companies. They cooperate because they know Tufts CSDD will generate a comprehensive and objective picture of the drug development process, while strictly ensuring that individual company data are not disclosed. Adhering to stringent methods of quantitative analysis, Tufts CSDD validates its data and develops findings based on rigorous academic standards.

Worth noting here that not all their research is  from ad industry POV. For example:

Dr. Joshua Cohen utilizes his background in health economics to examine public policy issues that concern prescription drug reimbursement and market access. His areas of research include pharmacy benefits management as it relates to the Medicare prescription drug benefit, formulary regulations established by the Centers for Medicare and Medicaid Services, ethics and the distribution of pharmaceutical care resources, comparative effectiveness research, market access to biopharmaceuticals in the US and Europe, role of clinical and cost-effectiveness in clinical practice guideline development, drug development targeting neglected diseases, and decisions by drug regulatory agencies regarding prescription (Rx) to over-the-counter (OTC) switches.

  • Patient access to newly approved oncology drugs in US and Europe
  • Clinical, regulatory, and economic challenges facing pharmacogenomics
  • Prescription-to-over-the-counter switches in US and Europe
  • Trends in biosimilar market uptake
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