Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Boston Scientific Ad for Watchman Medical Device Takes Shot at Blood Thinners!

Boston Scientific Ad for Watchman Medical Device Takes Shot at Blood Thinners! | Pharmaguy's Insights Into Drug Industry News |

This spring, viewers in four U.S. metro areas — Tampa, Detroit, San Diego, and Phoenix — saw the first television commercial aired by Boston Scientific, a 38-year-old maker of medical devices.


The ad, aimed at families of the millions of older Americans with irregular heartbeats, portrays a distraught adult daughter driving her father to the hospital. A doctor tells them about one of the Marlborough, Mass., company’s newest products: an implantable device called Watchman that seals a pocket in a patient’s heart chamber to prevent blood clots that can trigger strokes.


Such televised pitches are rare for medical device companies, which, unlike prescription drug makers, traditionally have steered clear of consumer marketing. But they are part of a strategy by Boston Scientific to promote a new generation of products designed to propel it into a top position in the markets for cardiac, endoscopic, urological, and other devices.


Boston Scientific’s chief medical officer, Ian Meredith — an interventional cardiologist and researcher recently recruited from Australia — conceded there was “a lot of hand-wringing” over whether to launch the television commercial. Ultimately, the company decided it was important to educate patients with atrial fibrillation, who bruise and bleed from the anticoagulant blood thinners typically prescribed to dissolve clots. Executives are gauging the ad’s effectiveness before determining whether to air it in additional markets, such as Boston.


“This is a very socially impactful ad,” Meredith said. “It’s really identifying that there’s an alternative for people who can’t take anticoagulation or who are struggling with anticoagulation [medicines]. And a lot of primary care doctors don’t realize this option’s available.”


Further Reading:

  • “Ad: 7th Annual Digital Marketing for Medical Devices - Save 15% use code PMN15”;
  • “Medical Device DTC Ads: Spooky, Outrageous Claims & Unregulated!”;
  • "Device DTC: Imagine How Far It Will Go!";
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FDA Officials - Including Commish Nominee Califf - Colluded with Device Industry to Draft "Cures" Legislation

FDA and the largest medical device lobbying group worked together to develop proposed legislative language for most of the medical device provisions included in the House-passed 21st Century Cures bill, one of the largest FDA reform bills to pass the House in recent years, and are developing a synchronized regulatory strategy for the Senate version, according to internal emails and documents obtained by Inside Health Policy through the Freedom of Information Act.

President Barack Obama’s nominee for FDA commissioner, who has come under fire for his past relationships with industry, was aware of the partnership between the agency and the device lobbying group on legislative proposals, according to the emails and documents, and attended meetings with the group along with FDA's acting commissioner and the device center director.

The agency defended the meetings with the device lobbying group as standard procedure and said that Congress requested technical assistance from FDA on the Cures legislation. And, while congressional sources claimed the practice of soliciting outside opinion on legislation was critical to the legislative process, sources off Capitol Hill said they were alarmed at the level of coordination between the agency and the device lobbying group and the amount of influence both parties had over the Cures legislation.

On Aug. 7, FDA officials, including Acting Commissioner Stephen Ostroff, Deputy Commissioner and Commissioner-nominee Robert Califf and Center for Devices and Radiological Health chief Jeff Shuren met with representatives from the Advanced Medical Technology Association (AdvaMed), including Steve Ubl, who then headed the association and is now president of the pharmaceutical drug lobby group, and Janet Trunzo, AdvaMed senior executive vice president of technology and regulatory affairs, as well as individuals from Johnson & Johnson, CVRx Inc. and St. Jude Medical Center.

A background document shared in advance of the meeting with a number of FDA officials, including Califf and Shuren, as well as Larry Morris, executive assistant to Ostroff, Sally Howard, senior advisor and acting chief of staff to Ostroff and Franklin Joseph, associate chief counsel for the agency, notes that FDA and AdvaMed met regularly during the legislative process and that the agency and the device lobbying arm had jointly written legislative text for Energy & Commerce Chairman Fred Upton’s (MI) signature piece of legislation.

Pharma Guy's insight:

Public Citizen said: "It should be unimaginable that the most senior Food and Drug Administration (FDA) officials would collude with the lead medical device trade association to write legislation to weaken the agency’s regulatory oversight and approval standards for medical devices. But that is exactly what appears to have happened. The result is contained within the House-passed 21st Century Cures Act – more accurately known as the False Cures Act – which would eviscerate the already far-too-weak safety rules for medical devices.";

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Anecdotal Evidence Good Enough to Approve Medical Devices According to Lawmakers

Anecdotal Evidence Good Enough to Approve Medical Devices According to Lawmakers | Pharmaguy's Insights Into Drug Industry News |

THE Food and Drug Administration has been regulating the approval of medical devices since 1976, but its regulatory oversight has not kept pace with the increasing complexity of this technology. Many high-risk medical devices today are approved on the basis of just one clinical trial (as opposed to new medications, which usually require two trials). And only a small minority of clinical studies of medical devices are randomized, controlled and blinded — the gold standard for reliable evidence (and the benchmark to which studies of drugs are held).

As a result, there have been many warnings about, and recalls and withdrawals of, medical devices that were found to be dangerous only after they were on the market. (In 2009, for example, the Sprint Fidelis defibrillator, which by that time had been implanted in hundreds of thousands of heart patients, was recalled because it frequently malfunctioned, harming many patients and leading to numerous deaths.) And because the F.D.A.’s oversight of medical devices once they are on the market is also weak, it is very likely that many malfunctions and other problems remain undetected.

Incredibly, legislation that the House of Representatives passed last week would severely weaken, not strengthen, the F.D.A.’s already ineffective regulatory scheme for medical devices. The device industry may stand to benefit from this legislation, but the health of the public does not. 

The legislation, disingenuously titled the 21st Century Cures Act, would make it possible for companies that produce high-risk medical devices to submit evidence of safety and efficacy based on sources other than clinical trials, including case histories (i.e., the experiences of individual patients). In other words, anecdotal evidence, rather than the scientific studies, could be used to approve devices.

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Medical Device DTC Ads: Spooky, Outrageous Claims & Unregulated!

Medical Device DTC Ads: Spooky, Outrageous Claims & Unregulated! | Pharmaguy's Insights Into Drug Industry News |

The medical device industry’s first highway billboard advertisements recently sprouted along roadsides outside Minneapolis-St. Paul and atop buildings downtown, sparking new discussion about medical devices following the example of direct-to-consumer drug ads.

Placed for privately held local company Torax Medical Inc., the trailblazing ads depict, in one rendition, a ferocious science-fiction type monster inside a stomach under the exhortation: Contain the beast that lives inside you.

Device manufacturers do not have the barrier of stringent FDA regulation that the agency erects to control drug advertisers.

The Federal Trade Commission (FTC) has primary jurisdiction over device advertising, as it does over nonprescription drug advertising, which was the primary competitive marketing force that persuaded Torax Medical to put up its highway billboards.

In sharp contrast to FDA, FTC has a long history of lax regulatory oversight of both nonprescription drug and device advertising.

When patients claiming severe quality-of-life harms from LASIK eye surgeries turned to FTC for regulatory enforcement under its truth-in-advertising authority, the agency just wasn’t interested.

Thus regulatory barriers need not deter medical device manufacturers from advertising.

So what’s holding everyone else back?

The bottom line for both medical device and prescription drug marketers is that as long as their advertised claims are not false and/or misleading, neither FTC nor FDA seems to be inclined to launch prosecutions—notwithstanding opposition from organized medicine.

Pharma Guy's insight:

Yes, regulation of medical device advertising seems pretty lax even when outrageous claims are made. Take this case, for example: "Device DTC: Imagine How Far It Will Go!"; 

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99% of Medical Devices Approved by FDA with Shockingly Little or No New Research

99% of Medical Devices Approved by FDA with Shockingly Little or No New Research | Pharmaguy's Insights Into Drug Industry News |
Even the devices that are studied the most probably aren't being studied enough.

Are federal regulators playing fast and loose with the health of the tens of millions of Americans who rely on medical devices to see, walk and survive? 

That's the suggestion of a new study that finds most medical devices go to market with little evidence that they work or are safe.

Groups like Consumer Reports and the Government Accountability Office have long criticized the U.S. Food and Drug Administration for approving medical devices that end up killing thousands of people a year. They've been most critical of the fact that the FDA allows 99 percent of new devices to go to market without any new clinical testing whatsoever.

But a team at the Yale School of Medicine found that even the 1 percent of devices that arestudied before getting FDA approval likely aren't being studied enough.

This 1 percent consists of so-called "high-risk" devices, which are very different from any others on the market and which are implanted within the body or directly support human life. The Yale researchers found that these devices are subjected to an average of just one major study apiece before being granted FDA approval. This means that doctors are implanting devices like coronary stents, replacement hips and intraocular lenses in thousands of patients after they've been tested on groups of just a couple hundred people each.

Pharma Guy's insight:

In contrast, of course, is the amount of evidence FDA requires to approve new drugs. But this may change -- for the worse -- if and when the 21st Century Cures Act is passed. For more on that, read " 21st Century Cures Act Could Weaken the F.D.A.’s Drug Approval Process"; 

The Act would also make Anecdotal Evidence Good Enough to Approve Medical Devices; 

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FDA Discloses Only 1% of Advisers' Financial Ties to Medical Device Companies

FDA Discloses Only 1% of Advisers' Financial Ties to Medical Device Companies | Pharmaguy's Insights Into Drug Industry News |

David Kandzari, an Atlanta cardiologist, also has worked as a consultant to makers of medical devices. He received at least $100,000 from them in five years, according to corporate and government data.

Another organization he works with, the Food and Drug Administration, doesn't appear to mind. In October, the FDA put Dr. Kandzari on a panel reviewing a medical device made by Boston Scientific Corp., one of the companies he has advised.

The FDA didn't disclose the connection. It was among numerous financial ties the FDA hasn't disclosed between medical-device makers and the doctors and other experts who review devices for it, a Wall Street Journal analysis of corporate, state and federal data shows.

In panels evaluating devices involved in cardiology, orthopedics and gynecology from 2012 through 2014, a third of 122 members had received compensation--such as money, research grants or travel and food--from medical-device companies, an examination of databases shows.

Nearly 10% of the FDA advisers received something of value from the specific company whose product they were evaluating.

The FDA disclosed roughly 1% of these corporate connections.

The situation concerns critics. "Undisclosed conflicts raise questions about the decision-making capacity of the committees and whether the public can have confidence in their recommendations," said Joseph Ross, an associate professor at Yale School of Medicine.

Pharma Guy's insight:

If you have ever attended one of these Advisory Committee meetings, you would find that the majority of attendees are representatives of drug companies with perhaps a smattering of public interest groups and a large contingent of press people.

So you can expect that every vote by each panelist is noted and reported back to drug companies with an interest in the matter. This has got to put a lot of pressure on the panel members, many of whom have accepted money from the industry in the past or perhapswould like to accept money from them in the future!

This goes with the territory of open, public meetings. It certainly would not be in the public interest to have secret ballots. So there's not much we can do about that.

But, can't the FDA find panelists without any ties to the pharmaceutical industry? Apparently not. A Washington lawyer "who was until last year the agency's general counsel, said that finding knowledgeable experts without financial conflicts was difficult."

The reason is that the industry creates these "knowledgeable experts," which has as much to say about physician education in this country as it does about pharma industry influence over physicians. In short, physicians absolutely depend upon the industry to learn about new products and even the conditions they treat.

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