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Wendy Dolin believes that a drug her husband was taking, an antidepressant called Paxil, played a role in his suicide by triggering a side effect called akathisia, a state of acute physical and psychological agitation.

“You have a situation where patients think they want to take a risk and don’t necessarily understand what risk they are taking," said Diana Zuckerman, president of the National Center for Health Research, which lobbied against the bill.

The chemical industry, while paying “lip service” to the new law, which it publicly supported, is now trying to “slow walk implementation and avoid anything by the EPA that is truly threatening” to its bottom line.

Women using the "permanent contraceptive" device called Essure are experiencing health problems, such as bad toothaches & headaches, hair falling out in clumps, unusually heavy periods, severe cramps, weight gain, brain fog, severe fatigue... and pregnancy.

“In addition to risks to patients, these FDA actions mean even less information about the devices that will be available to doctors and their patients,” she told Bloomberg BNA July 10. “How can doctors and patients make informed medical decisions without any any public information about these products? And how can medical care in the U.S. be made more affordable without requiring scientific evidence about safety or effectivene...

“It often takes months or even years for the F.D.A. to detect patterns of failure,” said Jack Mitchell, director of health policy for the National Center for Health Research in Washington. “Post-market surveillance of medical devices continues to be dangerously slow and clearly inadequate to protect patients from risky devices.” […]

Doctors who accept visits and gifts from pharmaceutical reps are more likely to be biased in which drugs they prescribe.

“FDA approval is based on evidence — provided by the company that makes the medical product — that the benefits of the product outweigh the risks for most patients for a specific use. It doesn’t necessarily mean the product is safe.” – Diana Zuckerman, President, National Center for Health Research.

Dr Reed, a mother of six, underwent the hysterectomy at Brigham and Women's Hospital in Boston, Massachusetts, to remove fibroid tumors. Power morcellation, intended to shred uterine tissue for removal through a laparoscopic incision, dispersed and upstaged an undiagnosed uterine leiomyosarcoma inside her abdomen.

“I have never known Congress that enthusiastically cut NIH funding,” she said. But she’s less sanguine about the fate of the Centers for Disease Control and Prevention, which would be cut by $1.3 billion, or just over 20%, in this budget. Congress loves NIH, but she said, “they don’t realize, whether it’s CDC or AHRQ (Agency for Healthcare Research and Quality), that they have a very important role to play.”

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Obamacare on the Chopping Block?

(MedPageToday, November 9, 2016)

"I'm not sure what will happen to the Affordable Care Act." NCHR President Diana Zuckerman noted that full repeal of Obamacare would be hard with so many people now relying on it, many of whom live in red states.

Does the FDA have a high enough standard for drug approvals?

(STAT, September 28, 2016)

Is the Food and Drug Administration’s approval process broken? At a HUBweek panel hosted by STAT, experts explored that question in light of the FDA's decision last week to approve a controversial drug for Duchenne muscular dystrophy, a rare disease.

Pro & Con: Experience well-suits her to deliver affordable care to all

(South Coast Today, September 28, 2016)

As her president husband’s point person on health care in the 1990s, Hillary Clinton learned what is needed to make health care affordable for everyone and how hard — but worthwhile — it will be to achieve that outcome.

Furor Over Drug Prices Puts Patient Advocacy Groups in Bind

(New York Times, September 27, 2016)

Public anger over the cost of medical products has burned hot for a year, coursing through social media, popping up on the presidential campaign, and erupting in a series of congressional hearings, including one last week over the rising price of the allergy treatment EpiPen.

FDA grants accelerated approval to controversial muscular dystrophy drug

(Washington Post, September 19, 2016)

After months of advocacy and speculation, the Food and Drug Administration today granted accelerated approval to the first treatment for a rare form of muscular dystrophy. The decision pitted the passionate testimony of patients and families against an FDA advisory committee and internal reviewers who weren't convinced the drug worked.

Feds to crack down on those who fail to report clinical trials

(Politico Pro, September 16, 2016)

Drug companies and research institutions will have to publicly report more clinical trial data, including results that show their products or experiments failed, under new policies rolled out Friday by HHS.  But NCHR president criticizes their decision not to provide summaries of treatment results that patients can understand.

How Parents Harnessed the Power of Social Media to Challenge EpiPen Prices

(New York Times, August 25, 2016)

What’s so unusual about the pricing furor is that it has almost single-handedly been orchestrated by parents and family members of people who use EpiPens. Patient advocacy groups, who typically are vocal on all issues related to food allergies, have been largely silent.

Cancer-Drug Ads vs. Cancer-Drug Reality

(New York Times, August 9, 2016)

It would be incredibly uplifting if it weren’t so utterly misleading and exploitive. To date, only about one in five patients with Stage 4 non-small cell lung cancer has seen any measurable response to Opdivo; and, in those patients who do respond, the median increase in life expectancy is only about three months compared with standard chemotherapy.

University Of California OKs $8.5 Million Payout In Spine Surgery Cases

(Kaiser Health News, August 1, 2016)

The University of California regents have agreed to pay nearly $8.5 million to settle two lawsuits alleging a well-known UCLA spine surgeon failed to disclose his conflicts of interest with a leading device maker before using the company’s products in harmful surgeries.

Celgene Accused of Using Charities ‘Scheme’ to Gain Billions

(Bloomberg, August 1, 2016)

Celgene Corp. donated hundreds of millions of dollars to charities that help patients afford high-priced drugs for multiple myeloma and other cancers “as part of a core business scheme to gain billions” from U.S. taxpayers, according to allegations in federal court filings.

Congress Shouldn’t Pass The 21st Century Cures Act In A Summer Rush

(Health Affairs, July 11, 2016)

The full Senate may in the next few days consider companion legislation to the 21st Century Cures Act that passed the House last year. The legislation—currently 19 separate bills—makes substantial changes to the way the Food and Drug Administration (FDA) approves drugs and devices. The legislation, while containing some useful measures, is flawed. Instead of hastily agreeing to it, Congress should postpone consideration until 2017 and attach the best of the 19 bills (see below) to must-pass legislation on FDA funding through industry user fees.

There's absolutely no reason why an EpiPen should cost $300

(Slate, July 8, 2016)

If you’re one of the 3.6 million people with an EpiPen prescription, you probably paid way too much for it—if you could afford it at all. That’s because, since buying the rights to the device nine years ago, the pharmaceutical company Mylan has pushed a relentless series of price hikes that has seen the cost of the device go from an average of about $50 in 2004 to more than $300 each today.

Women's Health Bills are Now in Congress

(Legal Reader, June 28, 2016)

Three important pieces of legislation, one introduced last year and two introduced this month, could change the way certain women’s health issues are handled. These women’s health bills are now in Committee.

How drug companies use gifts and internships to buddy up to their most valuable patients

(Washington Post, June 14, 2016)

In a striking new paper published in the journal PLOS Medicine, Kucab and colleagues detail the lengths to which drug companies do outreach directly to patients with hemophilia — gifts, assistance in paying for drugs, internships, college scholarships, apps where they can track their drug infusions and mentors. Kucab is a paid adviser to Bayer HealthCare, a company that manufactures "factor," the missing protein administered as an injection.

It’s worth asking questions when your doctor prescibes a drug off label

(Consumer Reports, June 10, 2016)

When the Food and Drug Administration approves a drug, the agency spells out who the drug is for, how to use it and what it’s supposed to treat. But your doctor isn’t legally bound to follow those rules, and about 20 percent of U.S. prescriptions are off label — written by doctors for a non-FDA-approved use. That means your physician might, for example, prescribe a blood pressure pill to calm your stage fright or an antidepressant to quell hot flashes.

Public wary of faster approvals of new drugs, STAT-Harvard poll finds

(STAT, May 11, 2016)

A majority of Americans opposes federal regulatory changes to speed up the development and approval of new medical treatments, a new STAT-Harvard poll finds — suggesting the public has serious doubts about legislation now moving through Congress. The poll also shows strong public support for removing prescription drug advertisements from television.

FDA head cites concerns with Cures bill

(Bloomberg, May 6, 2016)

FDA Commissioner Robert Califf May 5 said that if the 21st Century Cures legislation “is not carefully crafted it could pose a significant risk” for the agency and patients because it could cause drugs and devices to be approved too quickly.

“Innovative therapies are not helpful to patients” if they don’t work or they cause harm, Califf said at the Food and Drug Law Institute’s Annual Conference.

© 2016 by The National Center for Health Research. 

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