Tag Archives: Pharmaceuticals

Researchers ‘owe’ the public information about financial ties #ahcj14

Blythe Bernhard

About Blythe Bernhard

Blythe Bernhard reports on health and medicine for the St. Louis Post-Dispatch and serves on AHCJ's Right to Know and Contest committees. She attended Health Journalism 2014 as an AHCJ-Missouri Health Journalism fellow, a program supported by the Missouri Foundation for Health.

When writing about medical studies, reporters should always ask researchers about any financial relationships with drug companies or device manufacturers. That was one of the main lessons from a panel on conflicts of interest on Saturday at Health Journalism 2014.

Starting in September, sunshine provisions in the Affordable Care Act will require drug companies to disclose most payments to doctors. Some companies have already started to publicize their financial relationships with doctors. But most medical journal articles do not give accurate information on researchers’ potential conflicts of interest, said panelist Susan Chimonas of the Institute of Medicine as a Profession at Columbia University.

“You shouldn’t be uncomfortable asking these questions,” Chimonas said. “They owe you this information. They owe everyone this information.” Continue reading

CMS withdraws contentious parts of proposal to change prescription drug program

Joseph Burns

About Joseph Burns

Joseph Burns (@jburns18), a Massachusetts-based independent journalist, is AHCJ’s topic leader on health insurance. He welcomes questions and suggestions on insurance resources and tip sheets at joseph@healthjournalism.org.

Image by Amanda M Hatfield via flickr.

Perhaps the federal Centers for Medicare & Medicaid Services (CMS) learned a lesson over the past few weeks when it tried to make changes in its Part D prescription drug program. The lesson: Don’t mess with Part D in an election year.

On Monday, CMS withdrew its proposal to revise the Part D program, a proposal that drew widespread criticism from congressional Republicans and Democrats and from groups of patients, among others. Those in opposition said the proposal would undermine Part D, which members of Congress called a successful and popular program. More than 36 million elderly and disabled Americans get prescription drug coverage through Part D.

“Late last week, more than 370 organizations representing insurers, drug makers, pharmacies, health providers and patients urged CMS to withdraw changes it had proposed for Medicare Part D,” wrote David Morgan of Reuters. “The Republican Party had already begun to look for ways to leverage popular anger over the changes into campaign attacks on Democratic incumbents who could be vulnerable in November’s election showdown for control of Congress.” Continue reading

House committee grills CMS executive on proposal to revise Medicare drug plan

Joseph Burns

About Joseph Burns

Joseph Burns (@jburns18), a Massachusetts-based independent journalist, is AHCJ’s topic leader on health insurance. He welcomes questions and suggestions on insurance resources and tip sheets at joseph@healthjournalism.org.

A plan from the federal Centers for Medicare & Medicaid Services to eliminate protections for certain classes of drugs ran into stiff opposition on Wednesday when both Democrats and Republicans criticized the plan during a hearing of the House Energy and Commerce Committee.

Committee members questioned Jonathan Blum, principal deputy administrator of CMS, on the CMS plan to end the protected status for three classes of drugs (antidepressants and immunosuppressants in 2015 and possibly ending protected status for antipsychotics in 2016). Blum explained that CMS wants to foster competition and lower prices and that the proposal is not designed to limit the types of drugs that CMS covers, according to an article by Jennifer Corbett Dooren in The Wall Street Journal.

But perhaps the bigger issue involved whether the Part D proposal would allow CMS to get involved in price negotiations for medications. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, bars CMS from negotiating with pharmaceutical companies over the price of medications for Medicare beneficiaries. This provision of the 2003 law that established Medicare Part D, the prescription drug benefit, is known as the non-interference clause. Continue reading

Seeking to contain costs for six protected drug classes, CMS faces wide opposition

Joseph Burns

About Joseph Burns

Joseph Burns (@jburns18), a Massachusetts-based independent journalist, is AHCJ’s topic leader on health insurance. He welcomes questions and suggestions on insurance resources and tip sheets at joseph@healthjournalism.org.

Image by Amanda M Hatfield via flickr.

Image by Amanda M Hatfield via flickr.

Patient care advocates, drug companies, and both Republicans and Democrats are arguing against a proposal from the federal Centers for Medicare & Medicaid Services to eliminate protections for certain classes of drugs, including those for depression and schizophrenia.

Reporting on the proposal last week, Katie Thomas and Robert Pear wrote in The New York Times, “Opponents warn that the proposal, if enacted, could harm patients. Federal officials say it would lower costs and reduce overuse of the drugs.”

CMS estimates that the proposal will reduce overuse of some drugs and result in cost savings of $720 million by 2019, according to an AP article by Ricardo Alonso-Zaldivar.

Opponents say the proposal could result in increased hospital and physician services if patients can no longer get or afford the medications in six classes of drugs: anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals and immunosuppressants. Antidepressants and immunosuppresants would lose protected status in 2015 and antipsychotics would lose it in 2016. The other three classes (anticonvulsants, antineoplastics and antiretrovirals) would continue to be protected in 2015 pending further review by CMS, the proposal said. Continue reading

New data has some good news on use of antipsychotic drugs

Liz Seegert

About Liz Seegert

Liz Seegert (@lseegert), is AHCJ’s topic editor on aging. Her work has appeared in Kaiser Health News, The Atlantic.com, New America Media, AARP.com, Practical Diabetology, Home Care Technology report and on HealthStyles Radio (WBAI-FM, NYC). She is a senior fellow at the Center for Health, Media & Policy at Hunter College, NYC, and a co-produces HealthStyles for WBAI-FM/Pacifica Radio.

Antipsychotic drugs are used less often and patient-centered treatment for behavioral health, including dementia, is on the rise, according to new July data available on the CMS Nursing Home Compare website.

The agency said its efforts to reduce antipsychotic use in nursing homes by 15 percent by the end of the year seem to be working. In 2010, CMS data showed that at least 17 percent of nursing home residents received antipsychotic drugs exceeding recommended levels. CMS launched The National Partnership to Improve Dementia Care in 2012 to address this issue. Continue reading

Drugs remain on market despite fraudulent research; FDA withholds information

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

Despite concluding that a drug research lab’s violations “were so ‘egregious,’ and pervasive that studies conducted there between April 2005 and August 2009 might be worthless,” the FDA didn’t pull the drugs tested there from the market, according to a ProPublica piece by Rob Garver and Charles Seife.


Photo by Grumpy-Puddin via Flickr

The FDA is refusing to release information about those drugs, saying that “We believe that this did not rise to the level where the public should be notified.”

A statement from the agency said, “The issue is not a lack of transparency but rather the difficulty of explaining why the problems we identified at Cetero, which on their face would appear to be highly significant in terms of patient risk, fortunately were not.” Continue reading

LA Times: While board investigates, doctors’ ‘reckless prescribing’ kills

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism, and he has blogged for Covering Health ever since.

By zeroing in on one particular type of dangerous physician behavior, known as “reckless prescribing,” Los Angeles Times reporters Lisa Girion and Scott Glover were able to draw a powerful link between the state medical board’s inaction and patient death in an investigation titled “Dying for Relief.”

For the piece, reporters reviewed state medical board records and coroner’s files, assembling evidence that “At least 30 patients in Southern California have died of drug overdoses or related causes while their doctors were under investigation for reckless prescribing. The board ultimately sanctioned all but one of those 12 doctors, and some were criminally charged – too late to prevent the deaths.”

For its part, the board has been hit hard by state budget cuts and, the reporters write, is hamstrung because “Unlike medical regulators in other states, it cannot suspend a doctor’s license or prescribing privileges on its own, even to prevent imminent harm.” The resulting lack of oversight has led to pervasive overprescribing and uneven enforcement. For more details and a powerful narrative hook, I strongly recommend reviewing the paper’s brilliantly produced online package.

Health care watchdog agency provides ideas for stories in coming year

Len Bruzzese

About Len Bruzzese

Len Bruzzese is the executive director of AHCJ and its Center for Excellence in Health Care Journalism. He also is an associate professor at the Missouri School of Journalism and serves on the executive committee of the Council of National Journalism Organizations.

The HHS Office of Inspector General (OIG) has unveiled its FY 2013 OIG Work Plan , a blueprint for the watchdog agency’s work in the upcoming year and beyond.OIG 2013 Outlook Webcast at oig.hhs.gov

For enterprising health care reporters, this publication is like a catalog of story ideas, featuring hundreds of summaries of OIG’s upcoming reports, descriptions of its investigative and legal work, plus an overview of guidance it provides to the health care provider community.  Topics of upcoming reports include same-day hospital readmissions, oversight of poorly performing nursing homes, and FDA’s process for investigational new drug applications.

Also, on Oct. 24, OIG will launch its OIG Outlook 2013 webcast.  The free online event will include OIG’s senior leadership discussing emerging trends in combating fraud, waste and abuse in federal health care programs, OIG’s top priorities for 2013, and upcoming projects outlined in the Work Plan.

OIG’s mission is to protect the integrity of HHS’s 300+ programs – including Medicare and Medicaid – and the well-being of beneficiaries by conducting audits, evaluations, and investigations; providing guidance to the health care industry; and imposing civil monetary penalties, assessments and administrative sanctions.

Reporter tracks top prescribers’ ties to drugs they prescribe

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism, and he has blogged for Covering Health ever since.

A while back, Sen. Charles Grassley wrote to state health officials, asking for lists of top Medicaid prescribers of certain drugs. When her state released its, Lisa Chedekel of the Connecticut Health Investigative Team took it and ran with it, using all manner of public data to assemble a portrait of Connecticut’s prolific prescribers and the conflicts of interest that may drive them.

Speaking of conflicts of interest, Chedekel found that 43 of the 108 high prescribers (some broke into the top 10 for multiple drugs) earned money, meals or other benefits from the very companies whose drugs they were subscribing in such large quantities. She profiles a number of these physicians, but my personal favorite is one whose records show a curious correlation:

Dr. Kathleen Degen of Norwich was not among the top prescribers of Eli Lilly’s Zyprexa in 2008, but was the seventh-highest prescriber in 2009 (with 255 prescriptions), when Eli Lilly paid her $24,950 in speaking fees. Her prescribing fell off slightly in 2010, and she received $5,291 from Eli Lilly for speaking and travel. She disappeared from the high prescriber list in 2011 and received just $16 in meals from Eli Lilly, records show.

To better understand the problems that could arise from situations like these, Chedekel talked with academics, as well as a number of physicians named in the story. She also took a look at the drugs themselves, many of which Grassley had selected due to their controversial nature. The piece is a blueprint for reporting state-by-state on similar lists. The story also aired on Fox Connecticut.

Alzheimer’s drug puts journalists’ judgment to test

Judith Graham

About Judith Graham

Judith Graham (@judith_graham), a Colorado-based freelancer, is AHCJ’s topic leader on aging, and as such curates related material at healthjournalism.org. She welcomes questions and suggestions on aging issue resources and tip sheets at judith@healthjournalism.org.

It was the kind of news that had to be handled delicately, with a deft touch and a sense of perspective. A new drug appeared to halt the progression of Alzheimer’s disease for up to three years – a result never achieved before – but only in a handful of patients, according to results of a small study presented at a major international conference.

How did major media do in covering this development?

Marilynn Marchione of The Associated Press was careful not to overplay the findings and fuel speculation that definitive progress against Alzheimer’s had finally been achieved:

“For the first time, researchers are reporting that a treatment might help stabilize Alzheimer’s disease for as much as three years, although the evidence is weak and in only four patients.

“The drug is Gammagard, made by Baxter International Inc. Doctors say that four patients who have been receiving the highest dose for three years showed no decline on memory and cognition tests. A dozen others on different doses or shorter treatment times didn’t fare as well.

“The study was far too small to prove the treatment works, but a more rigorous one involving 400 patients will give results within a year.”

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Note what Marchione didn’t do. She didn’t call this a breakthrough. She didn’t suggest that results from this small study were reliable, or that they should give patients or medical practitioners hope. Instead, she was careful to strike a cautionary note from the start – the responsible way to approach this news.

At USA Today, Janice Lloyd took a very different approach:

“Although it’s still in a testing phase, the first long-term treatment shown to halt the progression of Alzheimer’s disease is being hailed Tuesday by experts at the Alzheimer’s Association International Conference 2012 in Vancouver.”

I’m sure this is true – that many experts at the conference indeed “hailed” the study’s findings. But practitioners in this field are primed to enthusiastically welcome any positive development since results of all other studies to date have been bleak. Putting this in the story’s lede gives a wrong first-off impression that this is a seminal event in the fight against Alzheimer’s. (It may be, it may not be; we don’t know yet is the truth of the matter.) Continue reading