Category Archives: In the News

After Years of Criticism, FDA Tries to Step up Oversight of Medical Devices

In the News, News Stories & Editorials
Amy Martyn, CONSUMERAFFAIRS: October 27, 2016

Makers of medical devices face such little scrutiny from the Food and Drug Administration that even a 2011 Institute of Medicine report, commissioned by none other than the Food and Drug Administration, described the agency’s medical device evaluation process as “fatally flawed.”

Even worse, the FDA has reportedly allowed device-makers to flout the few regulations that they are supposed to follow.

Federal law requires pharmaceutical companies to report any injuries possibly related to medical devices within 30 days of learning about the so-called “adverse event.” But a Minneapolis Star-Tribune report, published last April, details how Medtronic, the world’s largest medical device company, waited years before telling the FDA about more than 1,000 adverse events related to one of its medical implants, Infuse. […]

In a lengthy statement, the FDA tells ConsumerAffairs that it had granted an exemption to Medtronic and defended the company’s actions.

“FDA’s allowance of a summary report in certain circumstances, under the relevant regulation, is both appropriate and in the best interests of the public health,” the statement says in part. “Such summary reporting can create practical efficiencies by reducing data entry and FDA staff review time of information that is already well-understood about a particular device.”

Asked to comment, Medtronic referred ConsumerAffairs to a statement the company published online. 

Multiple companies

A follow-up report published this month details how the FDA similarly accepted late adverse event reports from multiple companies, not just Medtronic, without penalizing the companies.
“When patients have been horribly harmed by medical devices, they’ve notified the FDA. But nothing changes,” Dr. Diana Zuckerman, President of the Center for Health Research, tells ConsumerAffairs. “And, the FDA has not penalized companies that failed to report serious complications to the FDA, as required by law. The FDA’s track record could hardly be worse.”

Zuckerman’s complaints aren’t new. In 2014, three years after the FDA’s Institute of Medicine panel called its regulatory process for devices flawed, Zuckerman lead a separate study claiming that there is scant public research to back up the safety of many FDA-approved medical devices. The agency has repeatedly contested such critical findings.

Criticism invited

But recent actions by the FDA now suggest the agency may finally be taking some of the criticisms of its device regulation to heart. On October 21, the FDA launched a new online program to encourage anyone, from patients to doctors, to report misconduct by medical device-makers.

“The webpage is not in response to any recent news articles,” FDA spokesman Stephanie Caccomo tells ConsumerAffairs via email. “The webpage was developed to provide the public with more information on allegations of regulatory misconduct related to medical devices and provide clear instructions for reporting to the FDA.” For public health watchdogs like Zuckerman, whether the FDA’s new program will have teeth remains to be seen.

The FDA’s new site, “Reporting Allegations of Regulatory Misconduct,”  specifically singles out medical devices and instructs people to report anonymously if they wish to do so. “Anyone may file a complaint reporting an allegation of regulatory misconduct,” the FDA says, with instructions on how to submit complaints via email or hard mail. […]

For watchdogs like Zuckerman, the FDA’s new site soliciting allegations of abuse in the medical device industry is an encouraging step, but only on paper for now.  Though the new policy “sounds great,” she says, “will it make a difference? Will the FDA finally stop treating device companies like their favorite customers and remember that patients and consumers are their most important customers? …More importantly, will FDA finally decide that they will no longer allow device companies to ignore patient safety?”

For the full article, click here. 

Obama Extends Controversial Program for Rare Pediatric Drugs

News Stories & Editorials, , ,
Ed Silverman, STAT: September 30, 2016

Despite objections from his own regulators, President Barack Obama Friday signed into law a bill that will briefly extend a voucher program that rewards drug makers for rare pediatric medicines.

As a result, the program will run through Dec. 31 while Congress attempts to further extend the effort for another few years. […]

“This is important because if he hadn’t signed this extension, there would have been a gap in the program,” said Nancy Goodman, who is executive director of Kids v Cancer, a patient advocacy group. “And we need to maintain incentives for companies to develop these types of drugs.”

At issue is the pediatric review program, which was created in 2012 and awards a voucher to a drug maker that wins approval of a treatment for a rare pediatric disease, an area of drug development that was seen as neglected at the time.

The vouchers have gained notice in the pharmaceutical industry because they are valuable – companies can later redeem them when seeking approval from the US Food and Drug Administration for another medicine to treat any illness. […]

Moreover, the newly signed law appears to expand the potential for awarding vouchers. How so? The language may widen the patient population for which a drug may be used by broadening the definition of a rare pediatric disease to include symptoms that emerge any time before 18 years of age.

The language reflected an effort to modify the approach taken by the FDA for viewing certain diseases, according to Paul Melmeyer, associate director of public policy with the National Organization for Rare Disorders. This could also become a boon to drug makers. As the FDA Law Blog noted, “diseases that are extremely severe in childhood but tend to be less severe in adulthood may qualify” for vouchers.

Nonetheless, the voucher program is not universally embraced.

[…] the FDA strongly objects to the program.

FDA officials told the GAO they have not seen any evidence the program has encouraged increased development of drugs for rare pediatric diseases. They also maintained the program hinders their ability to set priorities because agency staff must provide priority reviews of new drugs that would not otherwise qualify.

Nonetheless, the push for an extension is also a timing issue. “It’s just before the election, so it’s not surprising for Congress or the White House” to support the extension, said Diana Zuckerman, who heads the National Center for Health Research, a nonprofit think tank.

Read the original article here.

Pro&Con: Experience Well-Suits Her to Deliver Affordable Care to All

News Stories & Editorials
Diana Zuckerman, SouthCoast Today, Seattle Times, Sacramento Bee, Norfolk Daily News, New Bedford Times, Bellingham Herald, and other publications across the country: September 23, 2016

SouthCoastToday affordable careAs 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.

She knows the issues inside-out, and her current proposals as a presidential candidate reflect her knowledge and commitment.

Excuse me while I mix a bunch of metaphors to describe the challenges ahead. Improving access to affordable health care in our country will require a complex juggling act, fitting together hundreds of puzzle pieces, and compromises from the major players, many of whom are on opposing teams.

The good news is that there are fewer uninsured Americans today than at any other point in our nation’s history. Likewise, people no longer are one illness away from financial disaster because of pre-existing medical conditions or because their age or health problems make them uninsurable.

The bad news is that many Americans say they don’t support President Barack Obama’s marquee Affordable Care Act, commonly called Obamacare, or are skeptical of it because co-payments and deductibles are increasing.

Fortunately, Clinton’s proposals to improve the situation are achievable — if Congress wants to improve access to health care instead of just complain about it.

Here are a few of her proposals:

— Reducing the price of prescription drugs. Nearly everyone agrees this is an important goal, but Big Pharma’s army of lobbyists have made it a tough one to achieve. Clinton has proposed several solutions, and my favorite is the simplest: scrutinizing prescription drug ads before they are allowed to bombard consumers. The U.S. is one of only two countries that allow these ads to be directed at consumers rather than just toward doctors. Also, as if watching the ads isn’t annoying enough, pharmaceutical companies deduct the cost of the ads from their taxes but still count advertising as a research-and-development expenditure. Yes, really, advertising costs are included in the “costs of developing new drugs.” The misleading ads encourage inappropriate and expensive prescriptions that cost us billions of dollars and ought to be more heavily scrutinized, as Clinton has proposed.

— You’ve probably never heard of Federally Qualified Health Centers, but 25 million Americans get their care from these clinics every year. Clinton proposes doubling that investment to provide care for more Americans. Legislators like to get credit for bringing home federal money and ought to go along with this idea.

— Reducing the backlog of generic drug applications. Generic drugs are generally less expensive and, in turn, force brand-name manufacturers to lower their prices. Clinton proposes that generic drug manufacturers help pay for reducing the backlog, since the move will benefit their bottom lines.

— Expanding Medicare to make it available — not required — for people 55 and older, instead of only people 65 and older. The cost of Medicare, which is not free, is different for every person and based on income. Americans generally love Medicare, and many would benefit, so if Congress is functioning, this could become law.

— Expanding Medicaid in every state. Medicaid provides health care to the poorest Americans in all 50 states, but 19 states have refused federal funds to expand it. The number of states participating in this expansion has slowly increased as it has become obvious that red states, such as Kentucky, have benefited the most. Expanding coverage in all 50 states will be tough, but Clinton’s plan to use incentives should nudge things in that direction.

These are just a few ways Clinton proposes to make health care more affordable. It won’t be easy, but as a senator, Clinton was able to work with both parties to get legislation passed.

One big plus is that several of her proposals reflect her awareness that the Food and Drug Administration could help reduce the cost of our health care instead of increasing it. Just this week, the agency tentatively approved a drug that will cost $300,000 a year despite there being little evidence that it works. In improving the nation’s health care environment, preventing skyrocketing costs of unproven treatments is a great place to start.

Diana Zuckerman is president of the National Center for Health Research. She received a doctorate in psychology from Ohio State University and was a post-doctoral fellow in epidemiology and public health at Yale Medical School. Readers may write her at NCHR, 1201 Connecticut Ave. NW, Suite 1100, Washington, DC 20036. Distributed by Tribune Content Agency LLC.

 

Feds to Crack down on Those Who Fail to Report Clinical Trials

In the News, News Stories & Editorials
Brett Norman, 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.

The new rules address the fact that researchers have routinely flouted requirements to report data to ClinicalTrials.gov. A final rule from FDA and a complementary policy from NIH clarify which trials must be reported and project a new federal commitment to crack down on violators – threatening fines of $10,000 per day or disqualification from NIH funding.

The widespread failure by institutions to report the data is “simply unacceptable,” NIH Director Francis Collins said on a call with reporters.

“This is fundamentally an ethical issue,” FDA Commissioner Robert Califf said. “This is about maintaining the trust that we have with [clinical trial] participants … that if it doesn’t benefit them, it will benefit others.”

A 2014 review of the results of 400 clinical studies found that 30 percent had not been published or shared with ClinicalTrials.gov four years after they had been completed. A study earlier this year found that 43 percent of the trials conducted at 51 academic medical centers went unpublished two years after the trial was completed.

The new requirements, which will take effect in January, clarify that all NIH-funded studies must be published on ClinicalTrials.gov. The FDA will also require publication of studies being done on drugs and devices even if they have not yet been approved. Most studies must be reported within a year of completion, but those involving unapproved products could wait up to three years.

FDA and NIH are also expanding the range of information that must be published, including the demographic data on study participants, any adverse events and the original plan for statistical analysis. The latter is meant to combat so-called p-hacking – when the original hypothesis of an experiment fails and researchers massage the data to come up with some other positive finding that is statistically significant.

“We’ve had a problem where people do the trial and don’t like the result, so they do another analysis,” Califf said.

FDA and NIH decided not to require a lay summary of trial results that would enable the public – not trained in statistics – to more easily digest the information that is posted, angering some consumer advocates.

“That is an outrageous decision,” said Diana Zuckerman, president of the National Center for Health Research. “Without it, clinicaltrials.gov will not be providing useful information to patients.” The data won’t be useful to physicians either unless it is summarized, she said.

Collins and Califf said they had been uncertain how to keep “bias” from creeping into the summaries, adding that advocacy groups should be able to harness the relevant data and make it available in a way that would be more useful to patients. […]

To see the original article, click here

Doctors Downplaying Drug’s Suicide Risks Attract FDA’s Scrutiny

In the News, News Stories & Editorials
Anna Edney, Bloomberg: September 13, 2016

The U.S. Food and Drug Administration has a message for doctors: The money you’re taking from pharmaceutical companies may be clouding your judgment.

Research sites where Pfizer Inc. had paid doctors at least $25,000 in speaking, consulting or other fees reported sunnier results for its smoking-cessation drug Chantix, the FDA disclosed Monday. At those sites, doctors studying the drug’s possible link to suicide risk and other behavior changes reported fewer side effects than at locations where colleagues accepted lower or no payments.

The FDA’s findings — part of an agency review of Pfizer’s proposal to drop the most severe consumer warning on the drug’s label — demonstrate the federal government’s concern about the influence of consulting and speaking fees on medical decisions. President Obama’s 2010 health law requires drug makers to report such payments for posting to a public database. The law followed years of efforts by U.S. Senator Charles Grassley, an Iowa Republican, to make drugmakers publicly disclose financial ties to doctors. […]

Diana Zuckerman, president of the National Center for Health Research, part of a coalition of consumer and other groups that petitioned to keep the warning on Chantix, said the FDA staff report shows that it doesn’t trust the “integrity of the data.”

“FDA clearly seems to be saying we can’t trust the results of this study — the way it was coded, the way it was analyzed, and by the way there’s conflicts of interest,” Zuckerman said. […]

Outside experts are scheduled to meet Wednesday to advise the FDA about the necessity of the warning on Chantix. The pill’s “black box” label — the agency’s strongest — currently cites risk of “serious neuropsychiatric events” such as suicidal thoughts or behavior. Chantix generated $671 million in sales last year,according to Pfizer. […]

To see the original article, click here

Medical Devices Approved Using Low-Quality Data Affect Medicare Costs

In the News, News Stories & Editorials
Michael D. Williamson, Bloomberg BNA: September 8, 2016

High-risk medical devices are sometimes approved using low-quality clinical data and this increases Medicare costs, a member of a Medicare congressional advisory panel said Sept. 8.

The Medicare Payment Advisory Commission’s meeting session reflected its first major examination of the medical device industry. The session may portend a deeper examination of the device industry’s practices, which could cause Congress and/or the Department of Health and Human Services to change payment rates for devices and related services, as the commission’s recommendations are fairly influential among policy makers.

Commissioner Rita Redberg, a cardiologist at the University of California San Francisco Medical Center, called for further MedPAC examination of how to push the Centers for Medicare & Medicaid Services to more broadly consider quality over an entire episode of care when deciding whether to cover a device.

Commissioners didn’t vote on recommendations. However, they debated how MedPAC staff should further research device company practices and their role in driving Medicare costs. Results of that research could prompt the commission to draft recommendations in the future.

In a separate session, commissioners discussed MedPAC staff progress on developing a uniform set of quality measures that could be used under a unified Medicare payment system for all post-acute care providers.

Tie to Rising Medicare Costs

Devices with a high risk to patients are sometimes approved by the Food and Drug Administration using poor quality data, Redberg said. This can result in low-quality devices being implanted into patients. These low-quality devices then need to be deactivated or removed, which drives up Medicare costs. […]

Redberg’s stance received praise from the leader of a patient safety group. “I completely agree with Dr. Redberg,” Diana Zuckerman, president of National Center for Health Research, told Bloomberg BNA Sept. 8. The National Center for Health Research is a nonprofit that encourages new and more effective programs and medical treatments.

In addition, the CMS should advise the FDA about the lack of data and safety and efficacy analysis specifically on patients over age 65, Zuckerman said. The lack of data “is a major problem for drugs and devices,” she told Bloomberg BNA. […]

To see the original article, click here

21st Century Cures Act: Yes or No? No: Act’s Promise of Quick Cures Is a Brew of Ultra-Hype Mixed with Snake Oil

In the News, News Stories & Editorials
Diana Zuckerman, Chicago Tribune: July 21, 2016
This article was published in the Chicago Tribune, Baltimore Sun, Orlando Sentinel, Sacramento Bee, and syndicated in many other newspapers across the country.

Imagine that you or someone you love has a potentially fatal disease with no proven treatment, but there is a new experimental treatment available.

Would you rather be given that treatment for free by a top physician who carefully monitors your treatment as part of a clinical trial to study whether it works, or, would you rather pay more than $100,000 a year for the same experimental drug and hope your doctor gives you the right dose?

For more than a year, a bill misnamed the 21st Century Cures Act has been a major focus of Congress, with grand promises that it would save the lives of desperate patients, including those with rare diseases.

Despite unusual bipartisan support from Republicans and Democrats, the bill has not become law. Here’s why you should be relieved, rather than disappointed.

The 21st Century Cures Act, which some experts refer to as the 19th Century Fraud Act, is the worst threat I’ve seen to the health of adults and children, whether rich or poor.

Simply put, this proposed legislation is based on hype and hope, not reality.

It has been marketed like a Super Bowl halftime ad campaign featuring families with dying children praising members of Congress for giving them hope. Supporters have included scientists, university officials and investors who are likely to benefit financially, should the legislation become law.

Desperate patients also support it, not realizing it would pave the way for unsafe and ineffective medical treatments. Worse yet, those patients would need to pay hundreds of thousands of dollars a year while being unwitting guinea pigs in experiments that are falsely hyped as “promising treatments.”

There are thousands of patients who urgently need new medical treatments. Many feel like they have nothing to lose, and assume that a promising new treatment is their best hope. But new isn’t always better which is why too many promising new drugs are subsequently found to be a harmful waste of money.

If a patient has only one year to live and the new drug or device kills them even sooner, or causes a stroke or unrelenting nausea or horrible pain that won’t ever stop, it becomes obvious that they had something to lose after all.

That’s why these medical products were still being studied because decades of disasters such as Vioxx, metal hip replacements, DES, and thalidomide have taught us that there is a right way to test medical products. And that testing them the right way and waiting for the results to be conclusive will save more lives than taking short cuts.

One of the most dangerous aspects of the 21st Century Cures Act is that it urges the Food and Drug Administration to settle for preliminary study results based on “surrogate endpoints” which are little more than well-educated guesses that a treatment works, rather than scientific evidence of real benefits such as living longer or having fewer complications. The FDA already relies on those surrogate endpoints for new medical products more often than they should.

For example, a study published in one of America’s most prestigious medical journals found that half of new cancer drugs are approved based on such short cuts, but many of those promising results were later reversed when more conclusive studies show that the drugs do not help patients live longer.

The National Center for Health Research has found that many of those ineffective often toxic drugs cost more than $100,000 per year a cost that can bankrupt individual patients and also bankrupt Medicare.

You’d think Congress would want to stop this travesty, but campaign contributions and the power of well-connected lobbyists have convinced Congress that this bill is a good idea.

If you or a loved one has a deadly disease, whether it is cancer or a rare disease, you deserve treatments that work. If experimental drugs are your only hope, they should be free as part of a study that you can choose to participate in.

Changing the rules so that patients have to buy experimental treatments that could harm them is a dream come true for snake oil salesmen. We all deserve better.

To see original article, click here.

Selling Side Effects: Big Pharma’s Marketing Machine

In the News
Michelle Llamas, Drugwatch: July 2016

Convincing people they are sick and need a drug is a multi-billion dollar industry. In 2015, Big Pharma dropped a record-breaking $5.4 billion on direct-to-consumer (DTC) ads, according to Kantar Media. And it paid off for Big Pharma. The same year, Americans spent a record $457 billion on prescription drugs. The U.S. and New Zealand are the only countries where DTC is legal. Americans also pay more for drugs and devices than any other country.

The bulk of these ads appear on TV at a rate of 80 ads per hour of programming, according to Nielsen. Behind the drug and device ads saturating TV, radio and digital media are hidden costs and devastating side effects that companies don’t advertise, and critics say the ads drive up drug prices and erode the patient-doctor relationship.

With the price of drugs skyrocketing, politicians and health-care providers question Pharma’s DTC spending, which exceeds money spent on research and development. Even presidential hopeful Hillary Clinton called for an end to tax breaks for drug ads and for tougher regulations.

But the money spent on DTC is just one small cog in Big Pharma’s well-oiled marketing machine. Companies spend billions more on getting doctors to write prescriptions for their expensive brand-name drugs or devices for uses not approved by the Food and Drug Administration — a controversial practice called off-label marketing. […]

“Americans tend to think newer is better. If it costs more, therefore it’s better. If it’s new and it costs more, then certainly it is better,” Diana Zuckerman, president of the National Center for Health Research, told Drugwatch. “They sometimes think that the FDA only approves new drugs if they are better. There is no requirement in the law, nor does the FDA require that a new product be better. I’ve heard FDA officials say, ‘We’ve approved this drug. It doesn’t mean we recommend it.” […]

“Obviously, the companies are paying a lot of money for these ads for a reason. They know it affects how many people take these drugs and how many prescriptions are written. And to pretend that they don’t know what the impact is seems disingenuous at best.” […]

“If the real goal is to educate, they wouldn’t look like this. The goal is to persuade. These ads educate people as much as the ads for the GAP or ads for makeup educate. It is educating you to tell you that this product exists and that it’s great.” […]

“The FDA has written policies that sound good, but the reality is very different from the written policies.” […]

To see original article, click here

Lack of African Americans in Breast Cancer Studies Results in Less Effective Treatment and Higher Death Rate

In the News, New Cancer Research
Laurén A Doamekpor PhD, MPH and Diana Zuckerman PhD, Cancer Prevention & Treatment Fund

The disparity in breast cancer mortality between Black and White women has widened in our country’s most populated states.[1] Cancer experts usually conclude that although there have been advances in breast cancer screening, prevention and treatment, these advances have not been equally available to Black and White patients.

Most experts fail to mention that there is a fundamental problem that could explain this disparity:  lack of research on the kinds of treatment that are most effective for Black women with breast cancer.  Dr. Laurén Doamekpor and Dr. Diana Zuckerman of the National Center for Health Research published a short article in Cancer Epidemiology that agreed that although access is a problem, a lack of racial and ethnic diversity in clinical trials exacerbates this disparity.[2]

Clinical trials have provided essential information on the treatments and prevention strategies that work best, but those studies have focused on White women.  Patients of color are very underrepresented in clinical trials that are submitted to the Food and Drug Administration (FDA) when a company applies for FDA approval.[3] Since relatively few people of color are included in studies submitted to the FDA, and even fewer studies analyze and report safety and efficacy separately by race or ethnicity, scientists have not discovered  treatments that are safe and effective for minority patients if those patients metabolize certain drugs differently or tend to have different types of cancer, such as the “triple negative breast cancer” that is more common among Black women than White women. This contributes to racial disparities when treatments are not adequately tested for  safety or efficacy in these populations.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References

  1. Hunt BR, Whitman S, Hurlbert MS. Increasing Black:White disparities in breast
    cancer mortality in the 50 largest cities in the United States. Cancer Epidemiol
    2014. http://dx.doi.org/10.1016/j.canep.2013.09.009.
  2. Doamekpor LA, Zuckerman DM. Lack of diversity in cancer drug clinical trials may exacerbate racial disparities in mortality rates. Cancer Epidemiol
    2014. http://dx.doi.org/10.1016/j.canep.2014.06.007
  3. Food and Drug Administration. FDA Report: Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products, August 2013; 2014, Available at: http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM365544.pdf (accessed 31.03.14)

Faster Drug Approval: Winners and Losers

In the News, News Stories & Editorials
Kristen Fischer, HealthZette: June 28, 2016

By the time a drug is approved by the Federal Drug Administration, it’s been through extensive human clinical trials. There are so many obstacles to greenlighting any new medication or treatment, in fact, that it seems like it can take forever — with countless lives lost in the meantime.

Recently, due to calls for novel treatments that move faster from the (lab) bench to the bedside, a legislative effort is attempting to speed up that process. The 21st Century Cures Act would allow companies to submit evidence of safety based on patient stories instead of actual clinical trials.

The House already passed its own version; the Senate is expected to review it in the coming weeks, STAT reported.

While the measure could speed up the process, some people fear it would also remove a lot of quality control. And when it comes to health, it’s good to know that the medications you take have been tested extensively and are backed by reliable data.

Another concern is any new fast-track process would enable pharmaceutical companies, for the most part, to dictate the efficacy of a drug instead of the FDA as a third party. […]

In a Washington Post editorial, Susan F. Wood, an associate professor at George Washington University’s Milken Institute School of Public Health and a former FDA assistant commissioner, explained that the 21st Century Cures Act is based on an assumption that there will be more cures if drugs and devices are studied more quickly on fewer patients.

She, along with Diana Zuckerman, president of the National Center for Health Research, believes the studies would be too small to allow safety and effectiveness findings to be broken down into subgroups such as male and female.

“This embrace of smaller, more preliminary studies could drastically lower scientific standards. When fewer people are studied, it is more likely that a drug will seem safe and effective even if it has dangerous side effects for many patients — who may not have been included in those small studies,” they wrote. […]

To see original article, click here.