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

Why won’t the Cystic Fibrosis Foundation comment on the high price of the new Vertex drug?

Robert Weisman of the Globe reports today:

California scientist Paul M. Quinton learned that he has cystic fibrosis at age 19 and has speVertexLogoSOPnt his long career in his lab working on ways to cure it.

He is, in short, not the kind of person you’d expect to be fighting with Vertex Pharmaceuticals Inc., the company developing a new class of breakthrough drugs for the obstructive lung disease.

But he and a group of prominent cystic fibrosis doctors are doing just that. For the past three years, they have engaged in a private and largely fruitless dialogue with Vertex over their complaints that the Boston biotechnology firm is overcharging for its medicines.

At the end of the story he checks in with the group  that represents the interests of patients. They don’t say much:

ssA spokeswoman for the Cystic Fibrosis Foundation wouldn’t comment specifically on the price of Orkambi. But in a statement, the foundation said that the cost of doctors, hospitals, drugs, and diagnostics together places “a tremendous financial burden on people with the disease and their families.”

Worth noting that the CFF’s so venture philanthropy — non-profit investment in drug development — let to the ultimate development of one of Vertex’s CF drugs the new drug. A Nov. NYTimes story notes the foundation expected to receive $3.3 billion from selling the rights to the royalties to those drugs.

Proponents say it speeds drug development while also providing potential monetary rewards that can pay for even more research.

But there is some concern that a profit motive could divert the organizations from their primary mission — helping patients — and create a conflict of interest. For instance, the price of the main drug developed through Cystic Fibrosis Foundation’s investment is $300,000 a year. Kalydeco treats the underlying cause of cystic fibrosis 

Critics say that perhaps because a higher price means higher royalty payments, the foundation did not do enough to bring the cost down.

“I would like to see them do more to get the price of this drug down to something that is going to be sustainable,” said Paul M. Quinton, a cystic fibrosis researcher at the University of California campuses in Riverside and San Diego, who has the disease himself. “And I have some concern about the possible appearance of a conflict.”

Overdoing and underdoing it on #HIPPA, patient privacy

Friday’s “New Old Age” column in the The New York Times suggests tha HIPPA privacy rules are applied inconsistently.

ssIt’s become an all-purpose excuse for things people don’t want to talk about,” said Carol Levine, director of the United Hospital Fund’s Families and Health Care Project, which has published a HIPPA  guide for family caregivers.

Within families, decisions about how much health information to share, and with whom, often become complicated, as a recent study in JAMA Internal Medicine found. When researchers working to design online patient portals convened two sets of focus groups — one for people over age 75, another for family caregivers — they heard the usual tension between older adults’ need for assistance and their desire for autonomy.

“Seniors say, ‘I don’t want to burden my kids with my medical issues,’ ” said Bradley Crotty, the director of patient portals at Beth Israel Deaconess Medical Center in Boston and the study’s lead author. “And the family is saying, ‘I’m already worried. Not knowing is the burden.’ ”

The older group wanted help but not second-guessing or “spying,” Dr. Crotty added. They might agree to disclose the medications they take — just not all of them.

Moreover, the dynamic often changes with increasing disability or a health crisis.

“Say a senior has a serious medical condition — a stroke, for instance — and requires a lot of help and support,” Dr. Crotty said. “He could recover enough to want to take back control of his health information. It may go back and forth.”

Also note that the new Health Wonk Review is up at the Insure Blog.

Will the feds improve the quality of #nursinghome care? #longtermcare

The Boston Globe’s reporting on conditions in MA nursing homes suggests the need for reform.khn-logo1

From Kaiser Health News:

After nearly 30 years, the Obama administration wants to modernize the rules nursing homes must follow to qualify for Medicare and Medicaid payments.

The hundreds of pages of proposed changes cover everything from meal times to use of antipsychotic drugs to staffing.  Some are required by the Affordable Care Act and other recent federal laws, as well as the president’s executive order directing agencies to simplify regulations and minimize the costs of compliance.

“Today’s measures set high standards for quality and safety in nursing homes and long-term care facilities,” said Health and Human Services Secretary Sylvia M. Burwell. “When a family makes the decision for a loved one to be placed in a nursing home or long-term care facility, they need to know that their loved one’s health and safety are priorities.”

Officials announced the update as the White House Conference on Aging convenes Monday.  The once-a-decade conclave sets the agenda for meeting the diverse needs of older Americans, including long-term care options.  This month also marks the 50th anniversary of the Medicare and Medicaid programs, which cover almost 125 million older, disabled or low-income Americans. Medicare and Medicaid beneficiaries make up the majority of residents in the country’s more than 15,000 long-term care facilities.

“The existing regulations don’t even conceive of electronic communications the way they exist today,” said Dr. Shari Ling, Medicare’s deputy chief medical officer. “Also there have been significant advances in the science and delivery of health care that just weren’t imagined at the time the rules were originally written. For example, the risks of anti-psychotic medications and overuse of antibiotics are now clearly known, when previously they were thought to be harmless.

The proposed regulations include  a section on electronic health records and measures to better ensure that patients or their families are involved in care planning and in the discharge process.  The rules also would strengthen infection control, minimize the use of antibiotic and antipsychotic drugs and reduce hospital readmissions.

Revised rules would also promote more individualized care and help make nursing homes feel more like home.  For example, facilities would be required to provide “suitable and nourishing alternative meals and snacks for residents who want to eat at non-traditional times or outside of scheduled meal times.”

Residents should also be able to choose their roommates.  “Nursing facilities not only provide medical care, but may also serve as a resident’s home,” the proposed rules say. “Our proposed provision would provide for a rooming arrangement that could include a same-sex couple, siblings, other relatives, long term friends or any other combination” as long as nursing home administrators “can reasonably accommodate the arrangement.”

Consumer advocates are likely to be disappointed that officials are not including recommendations to set a federal nurse-to-resident ratio.

However, the proposed changes would require that nurses be trained in dementia care and preventing elder abuse to better meet residents’ needs.

“We believe that the focus should be on the skill sets and specific competencies of assigned staff,” officials wrote in the proposed rules, “to provide the nursing care a resident needs rather than a static number of staff or hours of nursing care that does not consider resident characteristics.”

Nursing homes will be required to report staffing levels, which Medicare officials said they will review for adequacy.

“It’s a competency approach that goes beyond a game of numbers,” said Ling. “If residents appear agitated, figure out why, get at the cause of the problem,” she said, instead of resorting to drugs to sedate residents.

Advocates for nursing home residents argue that because of inadequate staffing, residents with dementia are often inappropriately given antipsychotic drugs, even though that can be dangerous for them. The new rules would help control the use of these drugs by requiring the facility’s pharmacist to monitor drugs that are prescribed for excessive periods of time or other irregularities and require the resident’s physician to address the problem or explain in the resident’s medical record why the medication is necessary.

“We don’t have enough nursing staff,” Toby Edelman, a senior policy attorney at the Center for Medicare Advocacy, said before the rules were released.  Federal law requires only one registered nurse on the day shift for a 20-bed facility or a 500-bed facility, licensed practical nurses around the clock and sufficient staff to meet residents’ needs, she said.

“We don’t look at the specific staffing positions per se,” said Greg Crist, a spokesman for the American Health Care Association, which represents 11,000 skilled nursing facilities.  “We look at the needs of the individuals when determining staff levels, and that is best addressed in the resident’s care plan.”

Although there are also no provisions addressing enforcement in the proposed rule, Ling said  it “will permit detection of violations to enable enforcement  by lessening the noise.”

“The biggest problem is that the rules we have now are not enforced,” said Edelman.  “We have a very weak and timid enforcement system that does everything it can to cajole facilities into compliance instead of imposing penalties for noncompliance.”

A report by the Center for Medicare Advocacy last year found that some serious violations often were not penalized.

“Once the new rules are finalized, they will be added to the items nursing home inspectors check,” Ling said.

Kaiser Health News (KHN) is a nonprofit national health policy news service. 

Harvard health policy researcher in NYTimes story: Can virtual office visits cut healthcare costs? #hcr #telemedicine

No surprises in the growth of online health services. And while telemedicine and various forms of virtual visits abound, researchers are still gauging the impact on quality and costs.

Harvard researcher Ateev Mehrorta has been following the trend. He’s quoted in Saturday’s New York Times story on video consults

Even as virtual visits multiply, researchers say it is not clear whether they really save money or provide better outcomes..

Virtual urgent care visits are undoubtedly less expensive than trips to the emergency room, said Dr. Ateev Mehrotra, a professor of health policy at Harvard Medical School, who has studied telemedicine. “But I think it’s very plausible, and probably likely, that a lot of people who do a virtual visit would otherwise have stayed home,” Dr. Mehrotra said, pointing to research that suggests most people do not end up seeking care when they feel sick. “So it could increase health care spending over all.”

In May 2014, he spoke before the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health during a hearing on Telehealth to Digital Medicine: How 21st Century Technology Can Benefit Patients on May 1, 2014.

From ProPublica: Should drug companies report payments to non-doc prescribers?

 

Transparency Program Obscures Pharma Payments to Nurses, Physician Assistants

New data on drug and device company payments to doctors largely excludes nurse practitioners and physician assistants, though they play an ever-larger role in health care. One advanced-practice nurse pleaded guilty last month to taking drug company kickbacks.

propub logoA nurse practitioner in Connecticut pleaded guilty in June to taking $83,000 in kickbacks from a drug company in exchange for prescribing its high-priced drug to treat cancer pain. In some cases, she delivered promotional talks attended only by herself and a company sales representative.

But when the federal government released data Tuesday on payments by drug and device companies to doctors and teaching hospitals, the payments to nurse practitioner Heather Alfonso, 42, were nowhere to be found.

That’s because the federal Physician Payment Sunshine Act doesn’t require companies to publicly report payments to nurse practitioners or physician assistants, even though they are allowed to write prescriptions in most states.

Nurse practitioners and physician assistants are playing an ever-larger role in the health care system. While registered and licensed practice nurses are not authorized to write prescriptions, those with additional training and advanced degrees often can.

A ProPublica analysis of prescribing patterns in Medicare’s prescription drug program, known as Part D, shows that these two groups of providers wrote about 10 percent of the nearly 1.4 billion prescriptions in the program in 2013. They wrote 15 percent of all prescriptions nationwide (not only Medicare) in the first five months of the year, according to IMS Health, a health information company.

For some drugs, including narcotic controlled substances, nurse practitioners and physician assistants are among the top prescribers.

“Nurse practitioners see patients, order tests, recommend procedures and prescribe medications,” Dr. Walid Gellad, an associate professor of medicine at the University of Pittsburgh and co-director of its Center for Pharmaceutical Policy and Prescribing, wrote in an email. “It seems straightforward to think that their relationships with the pharmaceutical and device industries are of as much relevance as physicians, dentists, chiropractors, etc.”

He added, “If the purpose of the act is to shine a light on the relationship between industry and the health care sector, then you’ve left out an important component of that sector.”

When the Sunshine Act was drafted, those involved say, nurse practitioners weren’t part of the discussion. “Physician groups were among the stakeholders who were very engaged,” said Allan Coukell, senior director for health programs at the Pew Charitable Trusts. “Nursing groups weren’t part of the policy discussions and weren’t ultimately covered by the law.”

Still, Coukell said, “To the extent that a lot of prescribing now is done by health professionals who aren’t physicians, and a lot of marketing is directed at them, they ideally should also be part of the disclosure.”

Asked whether payments to these providers should be reported, a spokesman for the Centers for Medicare and Medicaid Services, which manages the disclosure system, said: “Nurse practitioners and physician assistants are currently not covered recipients under the statute for Open Payments.”

A representative of the Pharmaceutical Research and Manufacturers of America, the industry trade group, declined comment.

Although payments to nurse practitioners are not required to be reported under the law, a handful of companies did so anyway. Of the 606,000 providers who received payments in 2014, several hundred self-identified as nurse practitioners or physician assistants. The rest were doctors, dentists, optometrists, podiatrists and chiropractors. (Some of the self-identified nurse practitioners and physician assistants actually appear to be doctors, but have misclassified themselves.)

Alfonso was employed as an advanced-practice nurse at Comprehensive Pain and Headache Treatment Center in Derby, Connecticut. An investigation revealed that she was a heavy prescriber of Subsys, an expensive drug used to treat cancer pain, the U.S. Attorney’s Office for Connecticut said. Between January 2013 and March 2015, she wrote more than $1 million in Subsys prescriptions to Medicare patients alone, more than any other prescriber in Connecticut, prosecutors alleged.

“Interviews with several of Alfonso’s patients, who are Medicare Part D beneficiaries and who were prescribed the drug, revealed that most of them did not have cancer, but were taking the drug to treat their chronic pain,” the U.S. attorney’s office said in a press release.

Prosecutors said Alfonso was paid as a promotional speaker by Subsys’ maker, Insys Therapeutics Inc., for more than 70 dinner programs at a rate of about $1,000 per event. “In many instances, the dinner programs were only attended by Alfonso and a sales representative for the drug manufacturer,” the U.S. attorney said in the release. “In other instances, the programs were attended by individuals, including office staff and friends, who did not have licenses to prescribe controlled substances. For the majority of these dinner programs, Alfonso did not give any kind of presentation about the drug at all.”

The charge against Alfonso carries a maximum sentence of five years in prison and a fine of up to $250,000. Sentencing is scheduled for September.

Alfonso could not be reached for comment and her attorney has not returned a phone call. A phone call to Insys was also not returned, though the company said in a statement to The New York Times that it was committed to promoting Subsys “lawfully and appropriately.”

A ProPublica report last year identified Alfonso as among the top 20 prescribers nationally of the most-potent controlled substances within Medicare’s Part D program in 2012. At the time, we noted that she had been reprimanded and fined by the Connecticut health department in July 2014 for allegedly failing to examine a patient before prescribing/refilling narcotics.

Elissa Ladd, an associate professor of nursing at the MGH Institute of Health Professions in Boston, surveyed 263 nurse practitioners several years ago about their interactions with the pharmaceutical industry. Her survey, published in 2010 in the American Journal of Managed Care, found that nearly all had regular contact with drug company sales representatives. Nine in 10 believed that it was acceptable to attend lunch and dinner events sponsored by the industry.

Ladd said she supports mandatory disclosure of payments for nurse practitioners and physician assistants.

“Nurse practitioners think that they’re somewhat immune to this but I think that we’re no different than any other provider,” she said. “If nurse practitioners were reported on, I think that would be a huge concern for them. I don’t think they want to be perceived in a negative light.”

Look up your doctor in our Dollars for Docs interactive database to see if he or she has received payments from drug or device companies in 2013–2014. Also read our story about doctors who had the most interactions with the industry.

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