Category Archives: In the News

The worst new drug of 2014

In the News, News Stories & Editorials, , , ,
DIANA ZUCKERMAN, PHD, PRESIDENT OF The Cancer Prevention & Treatment Fund 

It’s only February, so it may seem early to be talking about one of the Food and Drug Administration’s (FDA’s) worst decisions of 2014. Yes, the year just started, but the FDA has already made a decision that could potentially harm thousands of patients.

The agency just approved a new diabetes medication that doesn’t noticeably improve health but may in fact cause cancer.

It’s called Farxiga (Dapagliflozin) and it will be available—and probably widely advertised—very soon. The good news is that the drug lowers blood sugar, which is a major symptom of type 2 diabetes. However, lowering blood sugar is not necessarily a way to improve health. The new drug is meant to reduce medical problems such as heart disease or kidney damage. Unfortunately, there is no evidence that it actually improves health—in fact, quite the opposite.

The FDA reports that the most common side effects of Farxiga are genital fungal infections and urinary tract infections. Not fun, but those aren’t its most serious side effects. If a patient has moderate or severe kidney damage (as many diabetics do), the drug is not beneficial and could cause further damage, possibly even renal failure.

But the more frightening news is that patients taking Farxiga in studies done for the FDA were more than five times more likely to contract bladder cancer than the patients who took an older diabetes drug. Based on the findings of the companies making and selling Farxiga, FDA scientists concluded that the drug might stimulate bladder cancer in patients already at risk. The fear is that patients take diabetes drugs for years, and the longer someone takes this drug, the greater their risk of cancer.

Bladder cancer can be fatal, and is especially dangerous in people who have diabetes.

The companies’ studies also found that patients taking the drug were more than twice as likely to get breast cancer as diabetics not taking the drug, but they say this could have happened by chance.

It’s important to mention that only a small number of African Americans were studied. Because African Americans are more likely to have diabetes than Caucasians, these studies should have included greater numbers of them to find out if the drug is safe or effective for them.

With so many other diabetes drugs already on the market, why would anyone want to take this drug, and why would FDA approve it?  Here’s the scorecard, based on information provided by FDA scientists and available on the FDA website:

  1. Is the drug new? Yes.
  2. Does it reduce the medical problems caused by type 2 diabetes, such as blindness, heart disease, kidney damage, or amputations? No.
  3. Can it cause kidney damage or make it worse? Yes.
  4. Does research show that patients taking it are more likely to get bladder cancer. Probably.
  5. Does research show that patients taking it are more likely to develop breast cancer? Maybe.
  6. Does research show it is more effective than most diabetes drugs on the market? No.
  7. Will it cost more than most other diabetes drugs on the market? No information on cost yet, but new drugs usually do cost more.

The FDA is requiring that the label for the drug warn patients with bladder cancer that they shouldn’t take Farxiga because it might make their cancer worse. Ya think? And, the agency is requiring the companies to study 17,000 diabetes patients for at least four years to determine whether and how often patients taking Farxiga are diagnosed with cancer, liver problems, or heart disease when the drug is taken for a longer period of time.

The FDA rejected this drug two years ago because of these cancer concerns and questions about how well the drug prevents the major risks of diabetes. But the FDA has been beaten up by many complaining congressmen since then, and by some patient groups, pushing it to approve more new drugs quickly rather than waiting for safety studies to be completed. Also, the pharmaceutical companies don’t like to take no for an answer, they spend lots of money on lobbying, and they are very effective at pushing FDA to reconsider rejections. Because of that, the FDA selected an advisory committee to review the data in December, and those doctors and scientists also expressed concerns about risks and benefits. I was at the meeting and pointed out that there were too many serious unanswered questions.

Despite my concerns, the concerns of FDA scientists and other experts, and the concerns of the advisory committee members themselves, the committee recommended that if the companies continued to study the drug after it was approved, in order to figure out what the actual risks are, the company could sell it now.

It’s too early to say whether this will be the worst decision the FDA makes in 2014. Maybe the diabetes patients who take it will be lucky and not be harmed by the drug. Or maybe only a few patients will develop cancer or kidney failure as a result of taking it. Or the FDA scientists who expressed their concerns could be wrong, and I could have made a mistake when I agreed with them. But regardless of what happens with this drug, it still would be a bad decision to allow the sale of a drug with such serious (potentially fatal) unanswered questions.

Given the epidemic of diabetes in this country, the risks are huge. For that reason, this drug worries me even more than some of FDA’s similarly mind-boggling decisions of 2013, such as:

  • A drug for hot flashes that has no meaningful benefits but can increase the risk of suicide among women who weren’t depressed
  • An antibiotic for pneumonia that seems to kill more patients than other antibiotics

I’ve always respected the scientists at the FDA for working so hard to try to keep all of us safe. I still do. But decisions are being made at the agency that seem to ignore scientists and science, and that is dangerous for all of us. Whether we have diabetes, hot flashes, pneumonia, cancer, or any other disease, we deserve better.

 

A version of this post appeared in The Huffington Post, Maria’s Farm Country Kitchen

 In 2018, the U.S. Food and Drug Administration (FDA) announced a new warning on Farxiga and other SGLT2 inhibitors because they can cause a rare but life-threatening infection of the genitals and area around the genitals. The infection is called necrotizing fasciitis of the perineum or Fournier’s gangrene.  

Clinical evidence in FDA drug approvals varies widely, study finds

News Stories & Editorials,
by Sabriya Rice, Modern Healthcare
January 21, 2014

Not every new drug approved by the U.S. Food and Drug Administration has undergone the rigorous clinical testing that physicians and their patients might expect, according to new research.

A study published Tuesday in the Journal of the American Medical Association finds that the FDA has “flexible standards” for approving of new therapies. Using publicly available information from the FDA drug database, investigators identified 188 novel therapies for treating 206 conditions approved between 2005 and 2012. Of these, 37% were approved on the basis of a single clinical trial, 38% on the basis of two trials and 25% had been tested in three or more trials.

Although most therapies were supported by at least one randomized, double-blind trial—the gold standard for clinical research—there was wide variation in the duration, size and completion rates. Comparative-effectiveness data was available for less than half of the indications.The purpose of the study, according to its authors, was not to suggest that the FDA is not rigorous in its approach to drug reviews. The regulatory flexibility allows for a customized approach, and the agency can rapidly approve potentially effective therapies for life-threatening diseases and those for which there is no existing, effective treatment, such as orphan diseases, said Dr. Joseph Ross, assistant professor of general internal medicine at Yale University School of Medicine and one of the study authors.

According to Ross, the drug approval variability is problematic in the sense that both patients and physicians feel the research is the same across all drugs approved.

The FDA, in a statement responding to the findings, explained that drugs may be tested in clinical trials that enroll hundreds of participants, while others, particularly those seeking to treat rare diseases, may be tested in trials that enroll only a handful of participants. “In all cases, however, the statutory standards of safety and efficacy must be met in order for the drugs to be marketed in the United States,” the agency said.

Whether or not the process has become too lenient has become a topic of debate among advocates.

The Progressive Policy Institute, a center-left think tank, acknowledged in a policy brief (PDF) that the FDA must strike a difficult balance. “If it is too lenient, (the FDA) will allow the sale of drugs and medical technology that could harm vulnerable Americans. Too tight, and the U.S. is being deprived of key innovations that could cut costs, increase health, and create jobs.”

Some argue, however, that physicians don’t have time to sift through statistical data on every new drug approved, and when they do, there is little information to choose from as they make decisions about the safety of new therapies.

“With new drugs, there is often an exaggeration of the benefits and underreporting of the risks,” said Diana Zuckerman, president of the National Research Center for Women & Families, who has testified at several hearings on drug safety. “There’s so much emphasis on drugs being the latest, the most innovative and novel—but unfortunately this usually means it’s just new, not necessarily better,” she said.

Zuckerman conceded that it’s a given that the FDA should have the flexibility to provide access to new treatments when there are no available options. “But the FDA shouldn’t be rushing studies for diseases that have good alternatives. It’s better to have an old treatment that is proven to be safe and effective than a new treatment that we don’t know is safe and may not improve health.”

“I think we can all agree that if you have a disease for which there are no available treatment options, that is the time to be flexible, although you’d still want the best possible research,” she said.

Ross, the Yale researcher who worked on the study, encourages physicians to be more nuanced with how new treatments are presented to patients. When prescribing newly approved drugs that have limited trial data, he said physicians should be clearer with patients about what the research shows. The physician should say, “There are not a lot of options, this drug was just approved, but we don’t know if it extends your life,” rather than giving the patient the impression the drug does things for which it has not been tested.

To view the original article in Modern Healthcare, click here.

How a recalled medical device killed a vet at Seattle’s VA Hospital- KUOW

In the News,
DECEMBER 2013

When Eddie Creed, a Seattle jazz musician, died at the Veterans Affairs hospital on Beacon Hill last year, his death certificate said throat cancer had killed him.

But a KUOW investigation reveals what his doctors knew: A medical device called an Infusomat, which had been recalled the month before, ended his life. Still, nobody knows why.

The week the device was recalled, a trainer for B. Braun, the German manufacturer that produced it, came to the Seattle VA to teach nurses how to use the machine. According to the nurses, the trainer told them that a correction was coming soon for the device’s breakable plastic clip, but it was safe to use the machines until they were repaired. So the VA started using the Infusomats despite the “urgent medical correction letter” posted at FDA.gov.

That recall was the most serious kind – a “Class I” recall. Class I doesn’t mean the product has to be pulled right away, but it does mean someone could die or be seriously harmed if the recall is ignored. The manufacturer said that improperly loading the Infusomat could lead to an uncontrolled flow of drugs. So could closing its door too hard and breaking a small plastic clip inside.

So far as anyone can tell, none of those problems happened with the Infusomat hooked up to Creed. But the machine malfunctioned anyway, draining all its morphine into Creed – three weeks after the recall.

VA officials in Seattle say they never received the recall letter. B. Braun had sent it to the Department of Veterans Affairs’ central office in Washington, D.C., where most recall notices go, according to VA Puget Sound Chief of Staff William Campbell. He said a Seattle VA nurse saw the urgent, Class I recall on the FDA’s website a few days after the recall was issued.

“It is the most urgent class, but it doesn’t mean that something needs to be done immediately,” Campbell said. “‘Immediately’ would mean you cannot use that pump unless whatever fix it is, is done right then and there.”

Jason Ford, the US spokesman for B. Braun, a manufacturer with more than $6 billion in annual revenue, declined to to be interviewed or answer questions for this story.

‘Not very confidence inspiring’

When Creed was in the Army in the 1950s, he directed a choir and played trombone in a marching band. Later, he played piano for Seattle’s Chamber Jazz Quartet.

“When he would play the piano, it just melted my heart and made me so proud of him,” said Sherry Evard, his partner of several years.

Creed was 77 when he died at the VA hospital. He had been struggling with throat cancer and went to the VA for end-of-life care in April 2012.

“The last time I saw Eddie was the night that he died, and as I left him, I kissed his forehead and said, ‘I love you,’” Evard said. “I had no idea that he was going to die that night, or I would have stayed.”

On his first day at the hospital, nurses hooked him up to a morphine drip for his pain. Evard said the nurses appeared to have trouble setting it up.

“They seemed concerned about how to get it started and a bit uncertain, maybe, that it was administering the morphine properly,” she said. But to the nurses’ credit, she said, they double-checked before they left.

“After they left, I said to Eddie, ‘That was not very confidence inspiring, was it?’” she said. “He just simply said, ‘No.'”

The Infusomat, a machine the size of a phone book, is designed to send precise volumes of liquid from a hanging plastic pouch into a patient’s IV line. B. Braun’s training materials emphasize safety and avoiding the danger of free flow — that’s drugs pouring out, uncontrolled.

According to a B. Braun training video: “Clinicians must be vigilant to be certain they are using the technology as intended to achieve the maximum safety afforded by the technology.”

But on Creed’s second night at the VA, something went wrong and the morphine flowed freely while he was asleep. Around 11 p.m., a nurse found a drained pouch of morphine hanging above his bed. Creed had received about 10 times the dose he was prescribed. He was pronounced dead minutes later.

Medical Device Recalls

Recalls of medical devices rarely make headlines. But over the past decade, the US Food and Drug Administration has seen a “dramatic increase” in the number of recalls affecting infusion pumps.

“Sadly, we actually have much more access to information about defective toasters, and certainly defective cars, than we seem to about defective medical devices,” said Diana Zuckerman, who heads the National Research Center for Women and Families in Washington, D.C. The nonprofit focuses on medical-device safety.

Manufacturers are required to notify their customers of the recalls. Often, Zuckerman said, the medical-device recall notice doesn’t reach the right hospital department or doctor.

“There’s a lot of ways that the information may not get to the right person in a timely manner,” she said. “In some cases, devices continue to get used that should have not been used at all anymore because they’re so dangerous.”

The FDA doesn’t say how quickly a hospital must act on a manufacturer’s recall, even a Class I recall. The VA’s Campbell said the VA handled this recall properly.

“This specific recall was something that needed to be scheduled in a timely manner, but it didn’t need to be done that day, and there was no need to remove pumps from circulation,” he said. “If that had been communicated, we would’ve done that without hesitation.”

The night that Creed died, the VA hospital set his Infusomat aside to investigate what went wrong. VA staff couldn’t find anything, so they brought in medical-device experts from the ECRI Institute in Pennsylvania. ECRI, an independent nonprofit, is listed as a federal patient safety organization by the US Department of Health and Human Services and accepts no funding from the medical-device or pharmaceutical industries.

“They did not find evidence of user error from the programming,” Campbell said. “They were not able to produce the free flow, either.”

In other words, the VA and the outside experts tried to make fluids flow freely out of the electronic pump again — as the morphine had flowed into Creed — but couldn’t. They also ruled out anyone misusing or tampering with the pump.

“A clip had not broken,” Campbell said. “When we first pulled the pump out of circulation, that was one of first things that was looked at, and the clip was intact.”

Doctors Don’t Indicate Accident

Why Creed died that night remains a mystery. Would quicker action on the recall have spared his life that night? Or would a newly repaired pump have had the exact same problem? There’s no way to know.

But Evard wishes doctors had been more immediately forthcoming with her about his death.

The night Creed died, a VA doctor telephoned Creed’s sister and Evard with the bad news. He asked if they wanted an autopsy to be done. They had no idea there had been a medical accident. They said no.

“A doctor called me and informed me that Eddie had passed away, but he did not indicate that an accident had happened,” Evard said.

Creed’s family members were informed of the accident the next day. But they were not asked again whether they wanted an autopsy.

Campbell acknowledged that seemed “a bit out of sequence,” because the family wasn’t able to make an informed decision. Campbell said the VA could examine how that happened. But one thing they can’t do now, or ever, is an autopsy. Creed was cremated five days after he died.

The VA investigated the accident almost immediately and brought in outside investigators as well. The hospital only released the findings to Creed’s loved ones in the past two weeks – after KUOW first reported events leading to Creed’s death.

The VA also did not report the accident to the county medical examiner as required by state law.

“We’re required to investigate any drug overdose or complication of therapy. Something goes wrong in surgery, a hospital reports that to us and we take jurisdiction,” Greg Hewett of the King County Medical Examiner’s Office said. “That wasn’t reported to us in this case.”

After KUOW brought the erroneous death certificate to the VA’s attention, VA Puget Sound officials issued a statement. It acknowledged the morphine accident as the main cause of Creed’s death. It blamed an internal communication error and said the VA is reviewing its policies to make sure such an error is not repeated.

VA officials said they reported the accident to the FDA. Such reports wind up in a national database of medical equipment accidents. The data is available to the public, but it is scrubbed of all identifying information – not just of patients or doctors involved, but of the hospitals as well.

“I think the important point here is there was no attempt to cover anything up. We were very open with the family from the get-go about the morphine over-infusion,” Campbell said.

Thousands Harmed By Medical Devices

Creed was just one of thousands of patients harmed by a malfunctioning medical device in the US every year. Finding out how or even where those events happened can be an uphill climb for families or others interested in hospital safety, particularly for those whose loved ones are patients at the VA.

If a malfunctioning device harms a patient at almost any hospital in Washington state, it has to be reported to the state health department. Those mishaps appear on a website the state has set up to provide more transparency around hospital safety.

VA hospitals and state-run psychiatric hospitals are the only ones exempt from that requirement.

As part of an agency-wide push for more transparency, the Department of Veterans Affairs does put a lot of information online about its hospitals, including various measures of the quality of care the hospitals provide.

But the VA shares little about its medical mishaps.

Other hospitals in Washington state must publicly disclose 29 different kinds of mishaps any time they occur. VA hospitals only reveal four types of mishaps. Those four mishaps don’t include what killed Creed: a medication error. The only way to learn about those at a VA hospital is if an individual involved comes forward, as Evard did to KUOW.

Infusomat: One-Star Rating

A December 2012 review from the journal Health Devices gave the Infusomat a one-star rating, lowest of the six drug pumps reviewed. With its general difficulty of use and risk of life-threatening free flow, the Infusomat “should be avoided,” according to the nonprofit journal’s reviewers.

Medication errors aren’t limited to any one brand. According to the latest numbers available from the FDA, the agency gets about 10,000 reports a year of infusion pump problems. About 120 people die each year and 3,800 suffer serious injuries from pump malfunctions.

National medical organizations started warning of the risk of drugs pouring uncontrolled out of infusion pumps more than a decade before that exact thing killed Creed.

“Eliminate the use of IV pumps and administration sets that are unnecessarily hazardous when alternatives exist,” the VA’s own National Center for Patient Safety advised in 2002.

In 2010, the FDA concluded that infusion pumps have resulted in “numerous, systemic problems with device design, manufacturing, and adverse event reporting.”

That year, the FDA started an infusion pump safety initiative. Three years later, the agency is still drafting voluntary guidelines for companies to use in manufacturing safer pumps.

FDA spokeswoman Morgan Liscinsky declined to answer questions about the safety initiative, other than to state that most manufacturers are following the draft guidelines.

In November, ECRI Institute, the medical-device research group hired by the VA to investigate Creed’s accidental overdose, called infusion pumps the nation’s number-two medical-technology safety hazard. They came in second only to an excessive din of medical alerts causing alarm fatigue in hospitals.

Uneven Standards

According to FDA watchdogs, the problems don’t stop at drug pumps. More than 90 percent of all new medical devices are cleared by the FDA without being clinically tested on humans.

“Implants and infusion pumps aren’t held to the same standards as a medication for tummy aches,” Zuckerman said. “If you’re a company, and you’re making a new infusion pump, all you have to do is paperwork that you say is evidence your new kind of infusion pump is substantially similar to another infusion pump that’s already on the market. It might be that infusion pump has never been proven safe or effective either.”

The FDA will even okay a new device if it’s similar to another device that’s been recalled. Legislation to close that loophole died in Congress last year.

The Institute of Medicine, the health arm of the National Academy of Sciences, said in 2011 that the FDA’s screening of new medical devices was unreliable and the process needed to be scrapped entirely.

Medical device industry lobbying groups didn’t respond to requests for comment. But the website of the Advanced Medical Technology Association praises the current FDA system, saying it “has a remarkable 30-year track record of protecting the public health while making safe and effective products available without unnecessary delays.”

As for the Infusomats at the Seattle VA, they were taken out of service two weeks after Creed died and moved to a warehouse where they’ve been sitting unused since. That’s $1.9 million of medical equipment the VA isn’t using because of Creed’s death. The VA returned to the older pumps the Infusomats were meant to replace.

“We’re all frustrated about not having a definitive answer,” Campbell said. “It prompted us to remove the pumps from service, and we’re comfortable having done that, but we really would like to know exactly what it was that happened. So I understand Mr. Creed’s loved ones’ frustration with this; we share that frustration.”

VA Puget Sound hasn’t taken any concrete steps to return the Infusomats or recover any costs from B. Braun. VA officials said they haven’t decided how to proceed.

 

Please find the original KUOW article here.

October surprise

News Stories & Editorials,
by Diana Zuckerman, PhD
October 2, 2013

In politics, an October surprise is when a candidate has dirt on his or her opponent that is saved for just a few weeks before the election, so that the opponent’s media coverage will be negative just as people are deciding who to vote for.

This year’s October surprise was different, since there are very few elections. This year, the October surprise will be:

  1.  How long will the government be shut down?
  2. Will millions of Americans lose the opportunity to buy affordable health insurance in a bargain to re-open the government or pass the debt ceiling bill?

We live in a Democracy, but the decision about this October’s surprise is going to be made by a very small group of Congressman. How did 2-3 dozen Tea Party Members in the House of Representatives get that power in a Congress of 535 people, and should they be applauded for their principles or shunned for their bullying?

And let’s remember what’s at stake:

  • While the government is closed down, some essential services will continue (such as Social Security checks) but approximately a million workers won’t be paid (a blow to the economy) and services will be curtailed (national parks closed, Social Security, disability, food programs for poor families, and passport services delayed, etc.)
  • U.S. healthcare is the most expensive in the world, and Americans don’t live as long in the U.S. as they do in 16 other countries, including Canada, Portugal, and Japan. The purpose of the Affordable Care Act is to save lives by providing affordable health insurance to millions of Americans.

For those who (understandably) have tried not to think about the crisis, here’s a short “October Surprise for Dummies” version.

  •  The federal government and the services it funds (military, Social Security, cancer research, veterans’ health care, grants to public schools, etc.) is funded for one year at a time, starting Oct. 1 every year. This year, none of the funding bills have passed for the coming year, so the government closed down on October 1.
  • The funding bill for the year starting October 1, 2013 did not pass when it was supposed to (months ago) because 2-3 dozen Tea Party Republicans have refused to vote to support a budget unless it specifically removes funding for the Affordable Care Act, which they derisively call Obamacare.
  • You might ask: don’t we live in a Democracy where a bill in the House of Representatives needs a simple majority (218 votes) of the 435 Members to pass? How can even a few dozen people stop a bill if more than 218 want that law to pass? The answer is that Speaker of the House John Boehner is going by a different set of rules. Instead of allowing a vote for the entire House of Representatives, which would certainly pass a budget that the Senate and President would agree to, the Speaker won’t allow a vote on a bill unless it has the support of a majority of just the Republican Members of Congress – not including the Democrats. For hundreds of years, laws have passed only because of bipartisan cooperation, but that is not even possible now. Without support from enough Tea Party Members, the Republicans can’t get 218 votes to prevent the government from shutting down unless the bill cuts funding for Obamacare.
  • Hence, no bill yet, and a shutdown of most government activities. For example, the Congress made an exception at the last minute for pay for our military, but not disability payments for our veterans. The irony is that even as the government shuts down October 1, the new health care law will continue. In fact, on October 1, millions of people went online or in health centers to figure out which policies to sign up for. Those patients were from all over the country, including the red states that have officially opposed Obamacare.
  • If Congress can come to an agreement to fund the government, the next crisis date is October 17, when our country’s debt ceiling is reached. Our government borrows money every year, because we spend more than our taxes can pay for. Congress then votes for a new amount of debt that it considers acceptable. Like the annual budget, the debt ceiling has been held hostage by the same Tea Party Congressmen (and women) who refuse to vote for it unless – you guessed it – Obamacare is repealed, or at least loses the funding it needs to provide health insurance for people who can’t afford it.
  • And, if Congress comes to a compromise to fund the government temporarily (for 6 weeks, for example), then we will still need to go through this again when the temporary bill expires. That’s why the Democrats have told the Republicans that they want to meet to discuss a compromise for a 1-year funding bill, not a 6-week funding bill.

Is this any way to run a country?

Some people believe that the Tea Party opponents of the 2013 funding bill should be applauded for their principled stand. After all, they ran for office promising to gut the health care legislation. But, what is it about “Obamacare” that’s so terrible that it is worth shutting down the government or letting our country default on the money it owes.

Under Obamacare, health insurance plans now must provide:

  • Prescription discounts for seniors
  • Family insurance policies must cover all children under 26, even if they don’t live at home
  • Starting in January, insurance policies must cover all pre-existing conditions, such as cancer and heart disease. And they can’t stop paying for coverage when a disease gets very expensive (no yearly limits or lifetime limits on coverage, which in the past have bankrupted many families)

Starting in January:

  • States can get free Medicaid coverage for adults and children up to 133% of the poverty level (about $30,000 for a family of 4)
  • People who don’t have insurance through their employer or Medicaid will be able to go to state “Insurance Exchanges” that offer affordable health insurance. The federal government will help pay the annual cost of insurance for people earning up to 400% of the poverty level.

Sounds good, doesn’t it? There is a catch, though. The “mandate” in the law requires every American to buy health insurance, starting in January. The Tea Party hates the mandate, but the penalty if someone doesn’t comply is only $95 for the entire year. That means that those who don’t like the law and don’t want to buy health insurance would get away with the equivalent of a depressingly large parking ticket.

Is a mandate requiring insurance coverage (as is done with car insurance) fair? Unfortunately, it is the only way to keep prices down, because now that pre-existing conditions are covered for health insurance policies, a person could otherwise delay buying health insurance until they know they will have major medical expenses. (That would be like buying retroactive flood insurance to pay for flooding damage that already occurred a major saving for you, but untenable for insurance companies).

And, let’s not forget that Obamacare became law because of the affirmative votes of most Members of Congress, and that the numerous efforts to pass a law repealing it have been unsuccessful, because it does, in fact, benefit millions of Americans.

What will this year’s October Surprise be? Let’s hope it will be a pleasant surprise–a Congress that respects its citizens enough to preserve majority rule–the linchpin of our democracy.

 

This article appeared on the Huffington Post on October 2, 2013.

New concerns on robotic surgeries

News Stories & Editorials
by Rani Caryn Rabin, The New York Times
September 9, 2013

In early March 2009, Erin Izumi, a woman in her 30s from Tacoma, Wash., underwent robotically assisted surgery to treat endometriosis. The operation at St. Joseph Medical Center dragged on for nearly 11 hours.

Ten days later, Ms. Izumi was rushed to an emergency room, where doctors discovered that her colon and rectum had been torn during the operation. She was hospitalized for five weeks, undergoing a series of procedures to repair the damage, including a temporary colostomy, according to her attorney Chris Otorowski.

But even though medical device manufacturers and hospitals are required to report every device-related death and serious injury to a database maintained by the Food and Drug Administration within 30 days of learning about an incident, no report about the case was made in 2009. Hospital officials declined to comment, and a spokeswoman for the manufacturer said it became aware of the incident only when Ms. Izumi filed a lawsuit. It disputed the claim and settled the case in May 2012.

That was not the only lapse in reporting problems with robotic surgical equipment, a new study has found.

The equipment, called the da Vinci system, is made by Intuitive Surgical Inc. of Sunnyvale, Calif. It has been on the market for more than a decade; more than a million procedures have been performed with it. Between January 2000 and August 2012, thousands of mishaps were reported to the F.D.A. In the vast majority of cases, the patient was not harmed, but among the reports were 174 injuries and 71 deaths related to da Vinci surgery, according to a study published last week in The Journal for Healthcare Quality.

Yet by combing news reports and court records, researchers at Johns Hopkins were able to find examples of botched operations that were not reported to the agency. They concluded that adverse events associated with the da Vinci were “vastly underreported.”

It is fairly well known that reports made to the F.D.A. represent only “the tip of the iceberg” of surgical complications and adverse drug reactions, said Diana Zuckerman, the president of the National Research Center for Women and Families and an expert on the safety of medical devices, who was not involved in the study. The consequence is that little is known of the real disadvantages of the equipment, and the injuries and deaths it may cause, even as robotic surgery is widely marketed to consumers, Dr. Zuckerman said.

In a statement, Angela Wonson, vice president of corporate communications at Intuitive, said that the new study “gives the misleading impression that Intuitive Surgical has systematically failed in its obligation to timely report known adverse events to the F.D.A.” On the contrary, she said, “We take this requirement very seriously and make every effort to account for all reportable events — even those from several years prior.”

The new study follows a series of reports critical of robotically assisted surgery. Documents surfacing in the course of legal action against Intuitive have outlined the aggressive tactics used to market the equipment and raised questions about the quality of training provided to surgeons, as well as the pressure on doctors and hospitals to use it — even in cases where it is not the physician’s first choice and she has little hands-on experience.

Nevertheless, robotic surgery has grown dramatically, increasing more than 400 percent in the United States between 2007 and 2011. About 1,400 da Vinci systems, which cost $1.5 million to $2.5 million, have been purchased by hospitals, according to Intuitive’s investor reports.

The expansion has occurred without proper evaluation and monitoring of the benefits, said Dr. Martin A. Makary, an associate professor of surgery at Johns Hopkins and the senior author of the paper.

“This whole issue is symbolic of a larger problem in American health care, which is the lack of proper evaluation of what we do,” Dr. Makary said. “We adopt expensive new technologies, but we don’t even know what we’re getting for our money — if it’s of good value or harmful.”

Part of the problem is that the reporting mandate “has no teeth,” Dr. Makary added. “In health care, one fifth of the economy, we have this haphazard smattering of reports that relies on voluntary self-reporting with no oversight, no enforcement and no consequences.”

F.D.A. officials said in a statement that the agency has issued warning letters in the past when facilities have failed to report, and that the agency can take further regulatory actions like injunctions or imposing civil financial penalties.

A 2010 study found that 56.8 percent of surgeons surveyed anonymously said they had experienced irrecoverable operative malfunctions while using the da Vinci system, Dr. Makary noted.

Women were more likely to be harmed during the robotic procedures, Dr. Makary and his colleagues found. Nearly one-third of deaths that were reported to the F.D.A. database occurred during gynecologic procedures, and 43 percent of the injuries were associated with hysterectomies.

“Any time there is a serious problem with the da Vinci, it should be reported,” Dr. Zuckerman said. “It’s the F.D.A.’s job to figure out whether this is a problem related to the device or a doctor error.”

Click here to view the original article on nytimes.com.

Letter to the editor: Still working to understand cancer

News Stories & Editorials
Diana Zuckerman, PhD
August 5, 2013

Originally published in The Washington Post

The Post article on the overdiagnosis of cancer clearly reported the need to reduce patients’ fear and confusion about “cancers” that many experts now agree are not really cancer, because they don’t spread and aren’t harmful [“Panel addresses overdiagnosis of cancer,” news, July 30]. The major obstacle has been uncertainty about how likely these conditions are to predict cancer or change into an invasive cancer in the future. That is part of the reason many patients are choosing overtreatment, such as bilateral mastectomies that are not recommended and are not medically necessary.

In 2003, our center brought together nationally respected experts to the National Cancer Institute to address these issues. There were substantial disagreements, but for the sake of women across the country, none of us gave up. Let’s hope we make more progress in the coming months and years than we have in the past decade.

The Op-Ed: FDA panels: too many conflicts or too little expertise?

Press Releases
By Diana Zuckerman, PhD
June 12, 2013

This Op-Ed was published by Pharmalive.com, to see the original post, click here.

Last week, a paper in the journal Science argued that a 2012 law that loosened conflict-of-interest restrictions on FDA advisory panels could not only allow more drugs with troubling side effects to enter the marketplace, but was actually unnecessary. The discussion, which analyzed the utility of caps placed on waivers, once again raised the thorny debate over conflicts and panel members (read more here). But Diana Zuckerman who is president of the National Research Center for Women & Families, a think tank, and long-time FDA observer, argues this only tells part of the story…

Should FDA Advisory Committee members be allowed to have financial conflicts of interest regarding the medical product they are recommending for approval (or recommending against approval)?  The answer is not as simple as it might seem.

The Searle Civil Justice Institute of George Mason University held a Congressional briefing this week on the subject and I was invited to participate. The funding for the institute came from the late Daniel Searle, former ceo of the pharmaceutical company GD Searle. The focus  was a report entitled “FDA Advisory Committees: An Empirical Examination of Conflicts of Interest,” that is being written by Joe Golec, Professor of Finance at the University of Connecticut, and two of his colleagues at the George Mason University School of Law.

The statistics compiled for the report focus on voting patterns for all the FDA advisory committee meetings on new prescription drugs in recent years. The results indicate that the committee members who get waivers allowing them to serve on the committee despite conflicts of interest vote very similarly to the committee members who don’t get waivers. The authors conclude that this shows that conflicts of interest don’t unduly influence voting patterns on FDA advisory committees. They also conclude that the members with conflict of interest waivers tend to have more expertise, and therefore are an important addition to the committees.

I do not doubt the data that the authors presented, but I question their conclusions. The publicly available information about conflicts of interest on FDA advisory committees is too limited, and the analysis misses the flavor of advisory committee meetings, as well as the not-so-subtle nuances regarding conflicts of interest.

FDA defines conflicts of interest as financial ties during the last 12 months, so even extensive financial ties in the recent past – or even 12 months plus one day earlier — would not be included and would not require a waiver. The FDA advisory committee that met over a year ago to discuss whether Yaz oral contraceptives are too risky to stay on the market is a perfect example.  Advisory committee members with previous extensive financial ties to Bayer, which sells the pills, but who did not have waivers voted in support of Yaz (and Yasmin, Beyaz, and other contraceptives made with the hormone drosperinone). This shifted the vote to keep these pills on the market.

In addition to the many conflicted advisory committee members who don’t get waivers because their financial ties are more than a year old, voting patterns don’t tell the whole story.

I’ve been to dozen of advisory committee meetings, and I’ve seen how members with financial ties to the company or product often talk more at the meetings. They may talk more because they know more. They may talk more because they want to show the company how smart or helpful they are. Whatever the reason, their greater participation can be influential. Many advisory committee members ask no questions and make no comments at these meetings, until required to explain their votes. The advisory committee members with more direct knowledge of the products, including those with financial ties to the company or the product can greatly influence the vote when they talk more, ask softball questions or steer the conversation toward topics of benefit to the company. These members may have grants or consulting relationships with the company.

For committee meetings reconsidering safety issues for popular products such as Vioxx, Avandia, Yaz, osteoporosis drugs, surgical mesh, hip joints, and breast implants, advisory members who have frequently prescribed or implanted the products being reviewed are not considered biased and also do not have waivers. These potentially more knowledgeable but less objective members influence how others vote, making a comparison between members with waivers and members without waivers rather meaningless.

After attending so many advisory committee meetings, and studying 89 of these meetings in ourreport what is striking to me is how many of the members are not truly experts worthy of giving advice to the FDA. In fact, many of these voting members don’t understand statistics and ignore the clinical trial data unless they support their desire to get the drug on the market or keep it on the market.

Advisory committee members tend to be clinicians who want more drugs to be approved, making comments like “if this drug can help one patient, we should get it on the market.” For example, I recently went to an advisory committee meeting for Merck’s new sleeping pill, suvorexant, where the members ignored the FDA’s concerns that the data indicated many patients would have trouble driving to work the next day and could even fall asleep at the wheel (read here).

These sleeping pills had a half-life of 12 hours. Most of the advisory committee members didn’t care about that at all. Instead, they focused on the fact that people have insomnia and need help falling asleep. I think that people who take sleeping pills are mostly concerned about getting enough sleep so that they can function well the next day. A good night’s sleep doesn’t seem so beneficial if it means falling asleep while driving to work the next day.

At a meeting a few months ago, FDA advisory committee members recommended approval for a TB drug that was five times as likely to kill the patients as the current standard of care, a statistically significant difference. The sponsor, Janssen, speculated that the high death rate happened by chance in this randomized double blind clinical trial.  Amazingly, that ridiculous justification was good enough to convince most of the advisory committee members. Apparently, they didn’t understand that the entire purpose of a statistical analysis of a randomized double blind clinical trial is to determine whether or not a difference in outcome occurred by chance – and this one almost definitely didn’t.

I am very pleased that FDA Commissioner Margaret Hamburg has asked agency officials to reduce the number of advisory committee members with waivers. Unfortunately, the waivers are just the tip of the conflict of interest iceberg. FDA advisory committee members continue to have many members with financial ties to the companies and no disclosure of who they are. The media have publicly outed some of those advisory committee members, but most of the time that information is not known to the public, or the reporters covering advisory committee meetings.

Meantime, the bigger problem is that so many FDA advisory committee members don’t understand statistics or truly value or understand the results of clinical trials. FDA is supposed to make decisions based on scientific evidence that patients are more likely to be helped than harmed by a new medication or medical device. FDA approval should not be based on speculation or wishful thinking about whether a drug might “help at least one patient.” When committee members ignore the documented risks and focus on their hope for unproven benefits, thousands of patients die unnecessarily.

The number of FDA advisory committee members with conflict of interest waivers is lower than ever, but many members still show clear bias in favor of approving drugs and medical devices that are not proven safe or not proven effective. Whether those FDA advisors have financial conflicts of interest, other types of bias, or lack of interest in scientific evidence will not matter to the patients who are harmed by these medical products. Unfortunately, that will be the legacy of too many FDA advisory committee meetings.

Maryland Playground Closes due to Possible Toxicity

News Stories & Editorials
Mila Mimica and Tracee Wilkins, NBC4 News Washington: June 13, 2013

A brand new playground in Greenbelt, Md. closed this week over concerns about a potentially toxic material in the mulch used for ground covering.

Just a few weeks after the playground opened, the City of Greenbelt closed it down because the mulch used was made of old tires.

“It’s actually a product that not too long ago President Obama put in the White House playground,” Greenbelt Assistant City Manager David Moran said. “The science we saw particularly from the EPA showed that it was below levels of concern.”

However, Diana Zuckerman with the Cancer Prevention and Treatment Fund said parents had good reason to be concerned about that mulch.

“Rubber mulch contains phthalates, which are chemicals that affect hormones, and other chemicals that are known to be harmful to our health,” Zuckerman said.

Monday night, Greenbelt County Council agreed to try an alternative called “Poured-In-Place” rubber.

The park remains closed in the near future until the mulch is replaced.

 

To view the original article, click here.

Senate Panel Approves Tighter Oversight of Compounding Pharmacies, but Bill is Under Fire

News Stories & Editorials
Lena Sun, Washington Post: May 23, 2013

Public health and consumer advocacy groups are attacking Senate legislation designed to tighten oversight of specialized pharmacies such as the one at the center of this past fall’s deadly meningitis outbreak, saying it does not adequately address health risks.

The bill, approved Wednesday by the Senate Health, Education, Labor and Pensions Committee, would create a new category of regulation by the Food and Drug Administration for these companies. The bill now heads to the full Senate.

The House has not drafted a bill, but a House subcommittee will hold a hearing Thursday about state and federal laws governing the specialized pharmacies.

The Senate bill would establish a new category of FDA oversight that would apply to a part of the industry that has grown rapidly over the past two decades, from small corner pharmacies into businesses that operate like large-scale drug manufacturers. Many of these pharmacies, known as compounders, make a wide array of sterile medications, including antibiotics and painkillers, and ship them across state lines. Unlike traditional compounding pharmacies that custom-mix medication for individual patients based on prescriptions, these compounders often ship drugs without a prescription.

These products, unlike drugs made by major pharmaceutical manufacturers, are not ­FDA-approved. And the enterprises do not face the same level of scrutiny from the FDA that traditional drugmakers do.

Under the Senate bill, companies that make sterile products without or in advance of a prescription and sell those products across state lines would be required to register with the FDA and be subject to regular inspections.

Some consumer groups say the category is too narrowly defined. Only companies that meet all the criteria would be covered. Excluded would be large compounding pharmacies that sell defective or life-threatening oral drugs,topical creams and gels, said Nasima Hossain with the U.S. Public Interest Research Group, a consumer advocacy organization.

A compounder that sells in only one state would also be exempt. In addition, “anything in pill form wouldn’t qualify, and many chemotherapy drugs are in pill form,” said Diana Zuckerman, president of the Cancer Treatment and Prevention Fund.

Public Citizen, a consumer advocacy group, has opposed the creation of a separate category of FDA oversight for large-scale compounding pharmacies. It says it would be better to require the companies to follow the safety requirements that apply to commercial drug manufacturers.

The FDA has sought greater oversight of certain types of compounding pharmacies since the fall outbreak. But in a statement, the FDA said it was concerned that certain aspects of the Senate bill would limit the agency’s enforcement ability.

“Unfortunately, the proposed bill does not yet provide the clarity necessary to appropriately oversee this industry and may limit FDA’s ability to effectively protect the public health,” the statement said.

One small wording change in the bill that passed the Senate panel could weaken the FDA’s authority, industry experts said. It says traditional compounding pharmacies are to be defined “pursuant to state law.”

State laws vary, so a company that might be considered a drug manufacturer in one state could be defined as a traditional compounding pharmacy in another and be regulated differently depending on state law.

Allan Coukell, an expert on drugs at the Pew Charitable Trusts, said Pew supports the Senate approach even though it has limitations. “We do think big compounders ought to be under FDA oversight,” he said.

In the fall outbreak, the New England Compounding Center of Framingham, Mass., shipped more than 17,000 vials of steroid shots to doctors’ offices and clinics in 23 states. Some of the vials were contaminated; the outbreak killed 55 people and sickened 686. In the eight months since the NECC-linked meningitis infections, at least 48 compounding companies have been found to be producing and selling drugs that are contaminated or created in unsafe conditions, according to a report by the Senate committee.

Allison Preiss, a spokeswoman for Sen. Tom Harkin (D-Iowa), chair of the panel, said the bill is a work in progress and will continue to be refined as it moves through the legislative process.

To view the original version in the Washington Post, click here.

Angelina Jolie’s Decision

Breast Cancer, Breast Cancer, In the News, News Stories & Editorials
Diana Zuckerman, PhD, Huffington Post: May 16, 2013

When I read about Angelina Jolie’s announcement this week, I cringed.

I have greatly admired her willingness to speak out on important issues over the years. Her public announcement about her mastectomies will certainly reassure some women that losing a breast to breast cancer isn’t quite as frightening as it had once seemed. But Ms. Jolie is a powerful role model to millions of women. What are the unintended consequences of the role she is modeling regarding breast cancer?

Is breast cancer so frightening that it is better for a woman to remove her breasts before she is even diagnosed? Obviously, that isn’t what Ms. Jolie is saying. She has one of the breast cancer genes (BRCA1), and that greatly increases her chances of getting breast cancer.

However, the extremely high risk that she quoted from her doctor (87 percent chance of getting breast cancer) was based on old, small studies. Newer studies have found that the risk of getting breast cancer for an average woman with BRCA1 is 65 percent. Since being overweight and smoking increase the risk and exercising and breastfeeding lower the risk, Ms. Jolie’s risk of breast cancer, even with the BRCA1 gene, could be considerably lower.

Of course, the lifetime risk of breast cancer would still be high, but it wouldn’t be nearly as high a risk during the next 10 years or even 20 years. According to experts, a 40-year-old woman with the BRCA1 gene has a 14 percent chance of getting breast cancer before she turns 50. That’s not nearly as frightening, and with regular screening and all the progress in breast cancer treatments, the survival rate from breast cancer is higher than ever. Many breast cancer patients live long and healthy lives. And, it is possible that by the time Ms. Jolie (or any other woman with BRCA1) got breast cancer in the future–if she ever did–the treatments available would be even more effective than they are today.

Thanks to mammograms, women are getting diagnosed with breast cancer at much earlier stages, making it safe to undergo a lumpectomy (which removes just the cancer) rather than a mastectomy (which removes the entire breast). And yet, American women are undergoing mastectomies at a higher rate than women in other countries–many of them medically unnecessary. Breast cancer experts believe that many women undergoing mastectomies don’t need them and are getting them out of fear, not because of the real risks.

As an actress whose appeal has focused on her beauty, surgically removing both her breasts when she didn’t have cancer was a very gutsy thing to do. But if we care about women’s health, we need to stop thinking of mastectomy as the “brave” choice and understand that the risks and benefits of mastectomy are different for every woman with cancer or the risk of cancer. In breast cancer, any reasonable treatment choice is the brave choice.

Nobody can second-guess Angelina Jolie’s choice–it’s hers alone to make. Fortunately for her, she has access to the best reconstructive surgeons in the country, and they will keep her breasts looking as natural and beautiful as possible, an advantage that most implant patients don’t have. If she has any of the common problems with her breast implants, she can afford to get those problems surgically fixed whenever she wants to. She can also afford breast MRIs every other year ($2,000 each), which the Food and Drug Administration recommends as a way to make sure that the silicone from the implants is not leaking into the lymph nodes.

Angelina Jolie is not in any way an average woman, and what felt right for Angelina Jolie might not be right for most women who are afraid of getting breast cancer, and not even for most women with the BRCA1 or BRCA2 gene.

I thank Ms. Jolie for speaking up about her decision, and I thank the many cancer experts who are doing their best this week to explain why double mastectomies are not the best choice for most women. Let’s use this teachable moment to have a frank discussion of the treatment choices for breast cancer and to encourage women to make decisions based on their own situations, not on the choice of a celebrity, however admirable she is. For each woman, it’s important to weigh her own risk of cancer–in the next few years, and not just over her lifetime–and the risks of various treatments, and to make the decision that is best for her.

To see original article, click here