Zimmer Persona Knee Revision Surgery Prompts Recall

Zimmer Persona Knee: They Don’t Make ’em Like They Used To

June 13, 2016, 08:00:00AM. By Gordon Gibb  FiDA highlight

Warsaw, IN

It’s a common refrain in the modern age: things are not as they were. People don’t respect each other, or each other’s property like they used to. The politeness of old has vanished. “They don’t make ’em like they used to.” And for the most part, things aren’t built to last. One must forgive such a lament coming from the plaintiff behind a Zimmer Persona lawsuit alleging a failed Zimmer Persona Trabecular Metal Tibial plate.

Pundits find it remarkable that while the life expectancy of Americans continues to rise - thanks in part to ongoing advancements in modern medicine, disease prevention and more active lifestyles - the quality of the “parts” employed to make us whole again continues to decline, or so it appears.

A fast-track approval process employed by the US Food and Drug Administration (FDA) to bring new products to market more quickly without the traditional, years-long clinical trial process isn’t helping.

There is little doubt that for the majority of Americans, prosthetic knee devices work well and are on track to achieve the assumed service life expectancy of 15 years or more. However, when patients begin having problems with their medical devices - again, in the minority - even an apparent small number can have sufficient statistical impact to warrant a product recall.

That’s what happened last year with the Zimmer Persona Trabecular Metal Tibial plate. The latter is a plate that sits atop the tibia and serves as the surface area for the prosthetic knee device. According to various attorneys engaged in Zimmer lawsuits, a growing minority of patients reported loosening of the plates. This, in part, appears to be exacerbated by a lack of bone growth into the tibial plate, which would serve to anchor the plate. For a statistically large number of patients, this bone growth was either insufficient or not happening at all, leading to Zimmer Persona Knee pain and failure of the artificial knee.

Just referencing the failure of a medical device, implanted into a human body and failing soon after implantation, is serious enough without consideration of where a patient might be, or the activity involved at the point at which an artificial knee fails: driving a car; crossing a busy intersection; skiing; even walking across the kitchen with a steaming hot cup of tea from which a patient could suffer scalds or serious burns were a Zimmer knee to suddenly fail.

Thus, the Zimmer Persona Recall of 2015 when the Zimmer Persona Trabecular Metal Tibial plate was voluntarily recalled by the manufacturer - a recall endorsed by the FDA. Many patients experiencing Zimmer Persona Knee pain from a failed Zimmer Persona Trabecular Metal Tibial plate and requiring revision surgery to replace the failed component(s) are filing a Zimmer Persona Metal Plate lawsuit to seek compensation for pain, suffering and even loss of income. Revision procedures are often more complex than the initial procedure, with higher rates of complication. Having to go through a second surgery so soon after the first, followed by additional rounds of physiotherapy and rehabilitation, can eat into an individual’s income and livelihood given the additional time away from work.

The Zimmer Persona Trabecular Metal Tibial plate, it should be noted, was brought to market through an FDA 510(k) Clearance, the regulator’s fast-track program that allows design updates or new devices substantially similar to those already on the market and performing well to be brought to market without having to go through a clinical trial.

Clinical trials are long-term tests on volunteer patients, conducted to establish the safety and efficacy of a medical device before it is released to market and made available to the general population. If there are problems that surface in clinical trials, the device can be revised prior to a full market release.

Zimmer Biomet (Zimmer) is not the only manufacturer recalling medical devices. Other blue-chip medical devices firms are becoming saddled with recalls. Similarly, the FDA 510(k) Clearance is available to most large device manufacturers.

Speaking of Zimmer, US Official News (4/14/16) reports another Zimmer Persona Recall, but this one has to do with packaging. According to the FDA, the recall involved the Persona Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty (REF # 42-5114-008-18).

The recall stemmed from a complaint that there were two sets of information on the box containing the product: One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.

The products at issue were distributed to various states in the United States as well as globally (but not Canada).

The Zimmer Persona Recall was voluntary, issued by the manufacturer.

https://www.lawyersandsettlements.com/articles/zimmer-persona/zimmer-persona-lawsuit-recall-10-21533.html?opt=b&utm_expid=3607522-13.DLfjpNTnSeOVrAk1Ud2uNA.1&utm_referrer=https%3A%2F%2Fwww.facebook.com%2F

Make YOUR thoughts known now! Bayer Essure BLACK BOX warning is not enough!

This is the link:

http://www.regulations.gov/#!submitComment;D=FDA-2016-D-0435-0001

The Food and Drug Administration (FDA) Notice: Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization, Draft Guidance for Industry and Food and Drug Administration Staff; Availability

My information is public and I chose 'Individual Consumer'

"In 2010, the FDA paid to fly me to Silver Spring MD for three days of training to be a CDRH (medical device) Patient Representative.  I have never been called to serve on an Advisory Panel because nearly 100% of all medical devices go through the 510(k) -aka 510 pray- clearance method.  The device manufacturer names a predicate device, submits a fee and some paperwork and the clearance is approved.  Bayer Essure coils are rare in that they were cleared through PMA which protects the manufacturer from any litigation.   The women harmed by Bayer Essure are truly sacrificial lambs.  They were not informed that there is absolutely no warranty on this product and that their basic civil rights to a jury trial are null and void.  The harm perpetrated by this German conglomerate is assured by the current proposed legislation.  The PMA should be immediately revoked so that patient rights to justice are restored.  If Bayer conducted a legitimate scientific study and the product performs (patient outcomes) as advertised, this will come out in ‘discovery’.  In any case, there should not be any more insertion of these coils until the safety and effectiveness of this device are determined.  The leadership of the CDRH is questionable, at best.  Dr. Jeffrey Shuren’s entire household income is dependent upon the medical device industry(his wife, Allison is the partner at Arnold and Porter, LLP and prepares companies for device clearance).  Dr. William Maisel was arrested and convicted of soliciting a prostitute, yet he maintains his employment and is instrumental in clearing devices for women’s pelvic health (he is a cardiologist!).  This legislation is far too little and far too late. " 

Joleen Chambers Comment Tracking Number: 1k0-8ofc-rm8e

Medical Device Industry and FDA Collude

An Industry Takeover at FDA?

Posted in Regulatory and Compliance by MDDI Staff on December 15, 2015 FiDA highlight

A recent controversy highlights the close relationship between FDA and industry, with some critics calling discussion of key legislation by the regulator and the regulated unethical. 

Jim Dickinson is MD+DI's contributing editor.

If the Obama Administration and its improbable industry supporters have their way, Robert Califf will become, sometime in January, the first FDA commissioner to “capture” the agency from the inside with a full remit of enthusiastic support from its regulated industries.

Califf has been on the FDA payroll as a deputy commissioner since he came from a Duke University cardiology professorship last January—a move seen at the time as setting him up for the commissioner’s slot.

His nomination has been vigorously attacked for the same reason it was quietly aborted in 2009 in favor of Margaret Hamburg—his long career at Duke University consulting with numerous drug companies, far more contact, and much closer, than any prior commissioner.

Califf’s looming appointment would seem a far cry from the impartiality standard imposed on his predecessors, perhaps best expressed in the 1978 words of FDA’s then-chief counsel Nancy Buc—to demonstrate “a healthy tension” between the agency and the industries it regulates by maintaining an “arm’s length” relationship.

That sounds quaint now. It comes from ancient history, being in vogue long before user fees came to FDA in 1993, bringing in their wake radical changes to the previously nervous FDA-industry relationship.

Today fee-empowered companies and their multiple Washington lobbies routinely sit down with FDA and its congressional minders at distances closer than arm’s length.

Among other things, they write legislation together. Behind closed doors.

News about this erupted in December, scandalizing public-interest watchdogs like Pubic Citizen and the National Center for Health Research’s Diana Zuckerman, who told Inside Health Policy the practice would never have been tolerated when she worked on Capitol Hill (1985-95).

“As a senator, President Obama would have spoken out forcefully against this, but this is his administration, so what is he going to do about it?” she asked.

The online publication broke the story after receiving emails and documents from FDA pursuant to Freedom of Information Act requests that showed close collaboration between AdvaMed and FDA in developing the 21^st Century Cures Act, which has passed the House despite criticism from former FDA commissioner David Kessler and others concerned that it could weaken FDA product approval standards.

For its part, Public Citizen publicly condemned senior FDA officials, including Califf, acting FDA commissioner Stephen Ostroff, and CDRH director Jeffrey Shuren, for “colluding” with AdvaMed on the bill, which the activist group said in a December 11 news release “would eviscerate the already far-too-weak safety rules for medical devices.”

Califf, it complained, “participated in at least one high-level strategy meeting with the industry regarding these efforts. No one from the FDA should ever have been involved in such a process, which violates the most elementary ethical standards...

“In response to this outrageous news, the U.S. Senate should, at minimum, halt consideration of Dr. Califf’s nomination until it has an opportunity to investigate fully exactly what occurred. We believe that news of Dr. Califf’s participation in this collusion with industry provides still further evidence that his nomination should be rejected.”

IHP reported that FDA and AdvaMed “had jointly written legislative text for Energy & Commerce chairman Fred Upton’s (MI) signature piece of legislation.”

The distinction between the unseemliness of FDA jointly writing legislative text with industry and conscientiously listening to industry’s viewpoints on the bill’s draft language seemed to be lost on both FDA and AdvaMed after the uproar arose.

An FDA spokesperson told IHP that agency officials “routinely meet with a diverse group of stakeholders” that include industry, as well as patient groups and consumer groups.

“With respect to 21st Century Cures, FDA met with industry, patient groups, consumer groups and other interested stakeholders to better understand their interests and concerns. Congress regularly asks us for technical assistance about how to modify language proposed by outside groups, as was the case here.”

An unnamed AdvaMed official was quoted by IHP as saying there’s nothing unusual about Congress seeking input from stakeholders, including regulatory agencies and trade associations during the legislative process. “The fact that an association and an agency might discuss how a particular piece of legislation might be operationalized or might impact them is not uncommon,” the official said.

Even a spokesman for the Energy & Commerce Committee weighed in to placate concerns that something untoward was going on with the 21^st Century Cures Act. The committee and its members welcome input from all parties, including stakeholders, outside experts and government agencies, and encourages parties “in and out of government” to find consensus around specific policy proposals.

All just business as usual, no big deal, everyone said.

So who’s right? The public-interest complainers who were kept out of the joint FDA-industry legislation-writing meetings, or the insiders who participated and are happy with the process the way it is?

To my mind, the answer depends on whether you trust the government to do the right thing when it huddles with industry behind closed doors in one scenario while it tries to discharge its statutory, user fee-influenced responsibilities with the same industry in another scenario.

The IHP report said that when asked about information that CDRH director Shuren had attended AdvaMed board meetings, FDA refused to release details of Shuren’s calendar and meetings.

This raises another troublesome issue pertaining to trust: FDA’s increasing secretiveness since it acquired, along with all other government bodies, the ability to exclude the public, including or especially the news media, from its inner daily processes and personnel.

This came about after the 9/11 terrorist attacks and physical security was installed in all government buildings. Prior to this, anyone, including journalists, could just walk in and talk to anyone who wanted to talk to them.

A lot of management-unapproved internal information leaked out this way, feeding trade media with early, pre-decisional news about policy developments, personnel moves, incubating regulatory and enforcement initiatives, turf battles, rumors and gossip.

All that has disappeared.

FDA has been zealous in expanding its “security” screens far beyond the merely physical (bag searches, ID checks, metal detectors, etc.) to impose visitor escort rules under which nobody speaks to anybody without pre-clearance and active monitoring, mugshots, and electronic recording—all for your “protection,” of course.

In addition, all news media contacts, whether phone or email, are screened, diverted, or denied by so-called Public Information Officers for suitability and whether or not they will reflect credit on the agency.

IHP got access under the Freedom of Information Act to emails and documents that did not reflect credit on the agency.

Perhaps the screeners failed to see danger in the documents and emails they released.

I have had some of my requests delayed in processing so long they were useless in a news sense when the requested documents finally showed up years later, and even several that never showed up at all.

This, of course, never happens with requests from user fee-paying regulated industry.

Or does it?

http://www.mddionline.com/blog/devicetalk/industry-takeover-fda-12-15-15

When is a Law Firm a conflicted and tax-deductible Lobbyist for Public Federal Policy?

How Large are the Public-Policy Practices Within Law Firms?

By Katelyn Polantz, Legal Times, @kpolantz  October 19, 2015 3:08 PM EDT

FiDA highlight and comment:  FDA/CDRH Director Jeffrey Shuren's wife (Allison Shuren) is a lawyer/lobbyist for Arnold & Porter  

Today we published our annual survey on public-policy practices in Washington, the Influence 50.

One of our most surprising results was the number of law firms that counted almost $100 million or more in revenue from work intended to influence federal policy. It was hard to compare these numbers to previous Influence 50 survey results, because of the way firms have changed their thinking and a shift in emphasis in our end to a more holistic measurement than congressional and the Justice Department lobbying disclosures.

So we can compare this year’s public-policy revenue numbers to another collection of revenue totals that exists: the Am Law 100 and Am Law 200. Almost every law firm on this year’s Influence 50 is an Am Law 100 or Am Law 200 firm, and thus The American Lawyer has reported each firm’s gross revenues for 2014.

It’s no surprise that the firms with the highest totals of public-policy work last year also measure as significant practices within their firms. Covington & Burling’s $99.89 million in public-policy revenue accounted for 14 percent of the firm’s gross revenue in 2014. King & Spalding and Akin Gump Strauss Hauer & Feld, our first- and second-largest public-policy practices in 2014, both saw their public-policy revenue reach 13 percent of firmwide gross revenue last year.

The firm with the largest proportion of public-policy and lobbying revenue was Brownstein Hyatt Farber Schreck, the 162nd largest national law firm in gross revenue for 2014 according to the Am Law rankings. The firm keeps its growing public-policy practice in Washington fairly separate from its general-service legal operation based in Denver.

The Am Law firm with the smallest proportional public policy practice was DLA Piper, a more than 3,500-lawyer operation that is structured as a global verein firm, with many more associated offices around the world compared to a traditional law firm partnership.

The chart below shows how much the 25 large law firms on this year’s Influence 50 emphasize their public-policy practices.

Read the full NLJ story here about how lobbying practices are structured within law firms.

And view the Influence 50 chart here.

Read more: http://www.nationallawjournal.com/legaltimes/id=1202740145872/How-Large-are-the-PublicPolicy-Practices-Within-Law-Firms#ixzz3pEZYA8md

The Influence 50: NLJ's Annual Lobbying Ranking

It's a complex influence world. Lobbyists aren't just creatures of Capitol Hill.

Katelyn Polantz, The National Law Journal

October 19, 2015  

SHAKE: Dentons’ Newt Gingrich, the former House speaker, greets Sen. John Thune.

Chip Somodevilla/Getty Images

Lobbyist Darrell Conner of K&L Gates likens a Washington public-policy practice to a three-dimensional chessboard, part of a daily mental challenge born decades ago from a grand vision of the lobbying game. But over the past few years, that chessboard has expanded even beyond its own dimensions.

"It's a much more sophisticated business in which we operate," Conner told The National Law Journal.

The NLJ's annual Influence 50 ranking, included in this edition, attempts to capture the third dimension of lobbying: the part of the practice that's never publicly reported. Most firms self-report to the NLJ their public-policy group revenue totals.

Four law firms said they took in $100 million or more for public-policy work — Akin Gump Strauss Hauer & Feld; K&L Gates; Wilmer Cutler Pickering Hale and Dorr; and Atlanta-based firm King & Spalding, which reported the most public-policy business in 2014.

King & Spalding's $117.8 million topped our chart of 50 firms. That revenue includes $4.45 million in traditional lobbying work disclosed to Congress and through the Foreign Agents Registration Act. The firm described another $113.4 million as other public-policy business that includes about a dozen different types of influence tasks such as strategic consulting, public relations, grassroots organizing, political law and state attorneys general lobbying. The firm said it does the largest amount of its public-policy work in government investigations, an "area of focus" that brings in lawyers and lobbyists from across several different traditional practices, according to Tom Spulak, chairman of the firm's government advocacy and public-policy practice group.

"The thing I don't think people appreciate is the size and the breadth of King & Spalding's Washington office," Spulak said. "People say we're an Atlanta firm. But this is a big office, and all of the focus is on the government."

King & Spalding reported almost $43 million in public-policy revenue to the NLJ for this survey last year. That's partly because our survey has changed. This year, we asked firms to measure their influence work more broadly so it focuses more on their nonlitigation regulatory activities. Some firms have redrawn and expanded in recent years their public-policy departments to commingle lobbyists, litigators and regulatory lawyers.

INFLUENCE 50: THE CHART

Regardless of how a firm defines the work, our survey results show there's a growing hidden world of influence that sweeps in millions of dollars each year for law firms and for many of the largest lobby shops. The lawyers and lobbyists who make this money still represent clients' political points of view and still, in essence, lobby. But they count the work separately from what federal disclosure laws require they report to Congress quarterly as so-called LDA numbers, or information published under the Lobbying Disclosure Act of 1995.

According to our data, corporate and private clients bought more than $1.5 billion of public-policy influence services from the 50 top law firms and lobbying organizations last year. Of that revenue, firms disclosed 35 percent to Congress. That portion represents the traditional pound-the-pavement legislative advocacy on Capitol Hill and before some political appointees that results in quarterly filings.

Fifteen law firms said their largest sources of public-policy revenue came from other approaches that don't require disclosures to Congress. This type of work often still relies on the skills of lobbyist-lawyers to petition, persuade and build support. The lawyers instead focus on nonlegislative branches of government, such as agencies, commissions and executive branch departments.

"In congressional lobbying, the work is done when the bill is signed," said Micah Green, co-chairman of Steptoe & Johnson LLP's government-affairs and public-policy group. "We keep the Hill informed and link the regulatory, the compliance, the litigation. It's a continuum of services."

WHAT FIRMS ARE DOING

Firms, especially law firms, put much of their influence power toward regulatory policy. And large firms, such as Den­tons, Covington & Burling, and Wilmer, say clients have clamored for more of the influence service known to some in Big Law as "law-plus."

"When we ask [clients] what their most significant challenge is [in hiring professional services], a few years ago they would say talent, value, the quality of providers. Now they say a shifting regulatory environment," Elliott Portnoy, chief executive officer of Dentons, said.

The approach isn't new, however; it's just marketed differently. Regulatory law practices have "always been there … since Louis Brandeis was on the Supreme Court," said Ivan Adler, a Northern Vir­ginia-based headhunter who specializes in placing lobbyists at firms. "The reason these law firms are in Washington is that."

The slowdown of legislation out of Congress has caused more lobbyists to focus their skills on executive branch players, ­several lobbyists at law firms said. Sometimes the lobbyists will generate support for regulations through grassroots strategy and social media. Other times they'll submit comments to agencies on regulatory proposals and lobby departments and commissions, which can trigger some public lobbying disclosures to Congress.

Besides traditional lobbying and regulatory law, Dentons, for example, offers to clients advocates who focus on state attorneys general investigations, congressional investigations and crisis communications, among other public-policy services.

Part of Dentons' draw relies on its high-profile hires. This year, it recruited former House Speaker Newt Gingrich as a "thought leader" and "strategic adviser," Portnoy said, and former Demo­cratic National Committee chairman and Vermont Gov. Howard Dean. a specialist in health care. The leader of the postmerger firm's public-policy group, Gordon Giffin, is the former U.S. ambassador to Canada. Neither Gingrich, Dean nor Giffin have registered as congressional lobbyists in recent years, an approach to political services that's become more desirable for former members of Con­gress.

Giffin likened his firm's practice to a grocery store that offers many choices to clients, and he compared nonlawyer lobby shops to a bodegas.

"Nobody says, 'I have a lobbying problem.' They have a problem," Giffin said. "Lobbying can be one of the things that is part of the solution."

He continued, as if pitching to a client: "Don't tell me what the solution is, tell me what the problem is. I'm in the business of dealing with government."

Covington, the largest law firm in Washington by head count, finds only a small portion of its influence revenue in registered lobbying. Last year, the firm made $12 million lobbying, according to congressional disclosures. But it reached almost $100 million in revenue from other public-policy practices such as government investigations and political law.

The firm is among the most ­traditional white-shoe law firms in the city, but even Covington has worked on advancing its lobbying brand. Dan Bryant, a former PepsiCo Inc. vice president, joined Covington in 2012 and raised the group's profile with hires from the Hill and by offering more frequent commentary on lobbying results to media outlets. Bryant left this month for the top government-relations job at Wal-Mart.

The public-policy group's next head, law partner John Veroneau, is a former deputy U.S. trade representative, current co-chairman of Covington's international trade and finance groups and a registered lobbyist. The group's additions in the past two years include former Ari­zona Republican Sen. Jon Kyl as senior of counsel and former Rep. Howard Berman, D-California, as senior adviser.

Covington senior counsel Stuart Eizen­stat, former European Union ambassador and veteran of several past Democratic presidential administrations, describes the public-policy approach in simpler terms. The firm's vision, he said, was to create a "mini-State Department" to collect outgoing influential government personnel and use them to negotiate in clients' favors. The international work may not necessitate public disclosures, but it uses the same tactics, he said. "This is lobbying. That's what this is. That's exactly what it is," Eizenstat said.

Akin Gump's lobbying head, Donald Pongrace, described his firm's policy-planning approach as much broader than what any quarterly lobbying report would capture. Recently, the firm completed a seven-year effort for the Gila River Indian Community in Arizona, a perennial multimillion-dollar lobbying client.

The work involved a legislative agenda as well as litigation settlement negotiations over water rights. These are major legal and political strategy undertakings, with diagrams, brain storms and white board sessions at the firm.

"Our job is not to be the people who have the relationships per se," Pongrace said. "What we can do is fight the war on multiple fronts."

LOBBY SHOPS AND LAW FIRMS

Lobbyists within law firms sometimes look down at competitors at lobby shops, the smaller nonlawyer operations.

One lobbyist at a law firm described the lobbying groups that populate smaller gross revenue levels as "three guys, a computer and a cellphone, sitting in Star­bucks." Several others describe nonlawyer lobbyists as people who know people on the Hill, but whose value ages as congressional staffs and members turn over.

Representatives of several lobby shops on the Influence 50 contradict that. The three-decade-old Podesta Group, with $45 million in revenue last year and 49 professionals, makes most of its money in congressional lobbying, then public relations. Nonlawyer companies BGR Government Affairs, Van Scoyoc Associates and Capitol Counsel also ranked among our list's top 25 public-policy firms.

Many nonlawyer public-policy businesses have obvious benefits compared to Big Law: fewer secretaries, no associates, smaller offices, no requirements to count hours for billing purposes. Lobby shop personnel pocket more of every dollar they earn compared to law firms.

"Law firms are selling hours. We're selling understanding, smarts, relationships," said Marc Lampkin, co-head of Brownstein Hyatt Farber Schreck's Wash­ington office. The law office is structured more like a traditional small lobby shop, with almost all of its income coming from publicly disclosed congressional work.

Kirk Blalock, of Fierce Government Relations in Metro Center, said lobby shops like his were happy to keep the operations rooted in congressional lobbying. "We stick to our knitting," he said.

In a way, the law firms do, too. Clients are happy to see most of the money they pay public-policy groups going toward legal services, which are tax-deductible unlike lobbying expenses, law firm leaders say. Yet they still want their law firms to offer some lobbying capabilities.

Take it from Steve Ryan, head of McDermott Will & Emery's public-policy practice. About one-sixth of the group's $28.9 million gross revenue came from congressional lobbying last year.

"My government strategies [group] is a tail on the firm and not the dog. We're a very happy tail, and we wag it a lot," Ryan said.

Contact Katelyn Polantz at kpolantz@alm.com.

Read more: http://www.nationallawjournal.com/id=1202740039589/The-Influence-50-NLJs-Annual-Lobbying-Ranking-#ixzz3pEbsXnWn

Call for Resignations of FDA/CDRH Directors Shuren and Maisel

Jeffrey Shuren, FDA/CDRH Director

Allison Shuren, wife of FDA/CDRH Director

William Maisel, FDA/CDRH Deputy Director

PREVENTABLE Patient Harm from lax FDA/CDRH regulation

Metal-on-metal hips  500,000

Pelvic Surgical mesh 70,000

Bayer Essure 20,000

Power Morcellator for pelvic surgeries

Duodenoscope infections

Bard 'Recovery' Blood Clot Filter fatalities

Medical Device Manufacturers' Role in U.S. Broken Health Care System

FORBES   PHARMA & HEALTHCARE | 4/24/2014 @ 1:00PM |1,911 views

America's Broken Health Care System: The Role ofDrug, Device Manufacturers

Robert Pearl, M.D.

Health care costs are dramatically higher in the U.S. than in the rest of the world. Yet our health care outcomes – from life expectancy to infant mortality – are average at best. There is little dispute over these facts.

The real debate comes when we ask why. While there isn’t one single answer, the rapidly rising cost of drugs and medical devices is a significant factor.

And the magnitude of this problem is likely to spike in the future if not properly addressed.

Pharmaceutical and medical device manufacturers have been criticized for their role in health care for over a decade. Little has changed. Americans pay significantly more for prescription drugs and medical devices than patients in the rest of the world.

The justifications for these extraordinarily high prices vary, but the industry is well aware that most patients have no choice but to pay whatever they charge.

Pricing Not Always Justified, Even For Better Products

Pharmaceutical pricing has long been a point of contention among manufacturers, patients and payers of health care (including insurers, employers and unions).

The U.S. drug patent system allows a drug discoverer to exclusively sell the new drug for an extended time period. Theoretically, this protection is designed to encourage new medical discoveries and enable a drug or device company to recoup its R&D investment.

Because the theory makes sense, drug manufacturers use it to defend their prices. Certainly, those higher prices could be justified for developing clinically superior products but, all too often, the added cost far exceeds the incremental benefit.

How does drug pricing work? It’s hard to say. Pharmaceutical pricing is opaque. Drug manufacturers aren’t asked to quantify their costs or compare them to projected sales and profits. Business school students learn that the price of a product isn’t determined by what’s reasonable but what the market will bear. A wide array of drug pricing examples would indicate that pharmaceutical and medical device companies hire a lot of business school graduates.



How One Drug Might Earn Its Maker A 2,500% ROI

Take sofosbuvir, a new drug used to treat Hepatitis C. It’s marketed as Sovaldi by Gilead Sciences.

As a more effective treatment of Hepatitis C than those available today, this drug will be a positive addition to the physician’s armamentarium. Its effectiveness at ridding the body of this virus justifies a higher price than the treatments available today.

But at $1000 a pill, its pricing is exorbitant, monopolistic, and disrespectful to the purchasers and patients who will bear the brunt of the massive cost.

It is estimated that total treatment costs will range from $84,000 to $200,000 per patient, depending on treatment length. That’s 10 to 20 times the cost of today’s approach. Is this a reasonable return for the company?

Drugs this expensive are typically produced for those with rare conditions. These “orphan drugs” should cost more per patient because of the limited treatment population. But Hepatitis C is a very common disease. It affects nearly 4 million Americans, according to the American Liver Foundation. So, this can’t be the reason.

High development costs are another oft-cited explanation for extremely high drug pricing. Typically, manufacturers don’t disclose exact R&D costs but Gilead is reported to have paid $11 billion for Pharmasset, the drug company that developed the medication that led to Sovaldi. From this purchase price, we can estimate the R&D costs of this drug.

At Sovaldi’s price-point, Gilead is estimated to recoup its total investment in less than 18 months with revenue estimates of $269 billion over the drug’s lifespan.

That would be a 2,500 percent return on investment.

Manufacturers of luxury cars or yachts can rightfully charge wherever they choose, but when patients in need have no alternative option, that’s just wrong. Interestingly, two other drugs with similar therapeutic responses will be available in the near future. It will be fascinating to see how they’re priced.

Compounding the high price of many medications is the reality that patients in others countries don’t pay nearly as much as those in the United States. The reason is that most governments across the globe regulate drug prices. To date, the U.S. Congress has prohibited the practice here.

The result is that drug sales in the U.S. subsidize a disproportionate share of a drug company’s research costs and contribute to much of the company’s margin, regardless of where in the world it is headquartered. If we want our businesses to be globally competitive, this needs to change.



Aggressive Advertising Gives Manufacturers An Edge

Clinically superior products may very well warrant incrementally higher prices. But what of the increasing prices for products that don’t add much value?

Let’s compare the laparoscope to the prostate robot. First, the laparoscope.

In the past, removing a patient’s gallbladder required a large abdominal incision. Then along came a new technologically enhanced laparoscopic removal with remarkably better results. Suddenly, rather than making an incision under the entire right rib cage and cutting through the abdominal muscles, surgeons could remove the gallbladder with two tiny punctures and a telescope-like device.

Before, the surgeon would have to leave large rubber drains in place for several days to reduce the risk of infection. Average recovery times took up to six weeks. In contrast, gallbladder removal today is a routine, minimally invasive outpatient procedure that most people recuperate from in a week.

Laparoscopic surgery was a miracle advancement. Hardly the same story as the prostate surgery robot.

Mention “robot” to most patients and they’ll assume it’s a space-age advancement with major clinical benefits. It sounds sexy and, intuitively, its approach to prostate surgery makes sense. After all, the robot has steady hands and requires a smaller incision.

The problem is the outcome data doesn’t support the hype or the cost. The results – in terms of both cancer eradication and surgical complications – are similar to traditional alternatives, according to most studies. And for most surgeons, the robot-assisted procedure takes longer.

The price tag for this device is over $1 million, but that’s just the beginning. The company behind the robot designed it with disposable “arms” and built in an obsolescence factor that forces the hospital to replace each arm after 10 uses. The motivation isn’t safety. It’s profit. The manufacturer could have built a robot that could complete 100 procedures. But that would reduce profits dramatically.

If the robots add little clinical value yet significantly increase costs, why do so many hospitals tout them? The answer: Aggressive advertising.

By simultaneously marketing to consumers and hospitals, these devices were strategically positioned to help hospitals lure patients from their competitors. And, of course, it worked. Big billboards helped early adopting hospitals attract patients with the promise of a new “high-tech wonder.” Once a few hospitals jumped on board, others had no choice but to follow.

Since the robot’s introduction, academic medical centers (university hospitals) train their surgical residents almost exclusively in its use. Gone or going are the more traditional methods. Unless patient expectations change or expanded competition is permitted, this will ensure that the manufacturer sees a large revenue stream for decades to come.

The result: This device will drive up health care costs significantly in the future, while clinical outcomes remain relatively unchanged.



Minimally Different Drugs Launched At Maximum Prices  

Even when a new product is essentially the same as an old one, manufacturers use their patent protections and market control to drive up revenues. A great example is an injectable drug for a medical problem called “wet macular degeneration.”

Manufactured by Genentech, Avastin is an FDA-approved drug for cancer treatment. It slows the growth of new blood vessels that feed a tumor.

A while back, a thoughtful group of ophthalmologists recognized that if this drug could limit blood-vessel proliferation to stop tumor growth, it might also be useful in slowing the overgrowth of blood vessels inside the back of the eye – the cause of wet macular degeneration.

These physicians tried injecting a very small dose of Avastin at about $60 per treatment with excellent clinical results.

But here’s where it gets interesting. Genentech recognized the same opportunity at about the same time. And instead of recommending Avastin as an effective treatment, Genentech created Lucentis, a new drug with a biologically active component identical to Avastin.

Once Genentech received FDA approval, it priced Lucentis at $2,300 a dose, never showing that it was superior to Avastin at $60 a treatment.

Ophthalmologists across the country were outraged. Adding insult to injury, Genentech tried to embargo sales of Avastin for non-oncology practices. Not surprisingly, when the National Eye Institute tested Lucentis against Avastin, it found essentially no difference for a drug priced 40 times higher.

Change Is Possible, Not Easy

There are legitimate reasons why some drugs and devices are very expensive. But it’s common for manufacturers to hike up prices even when the magnitude of improvement is minimal.

If we’re serious as a nation about making health care more affordable while increasing quality outcomes, we’ll need to rein in these practices.

We can begin by demanding that drug companies disclose the true cost of development as part of the FDA approval process. Regulatory agencies could then use that information to evaluate the appropriateness of the price.

The FDA could also require all new agents and devices to be tested against existing approaches so that pricing and incremental value can be measured. Finally, we can make all of this information available and transparent to patients, so they can make the best decisions for themselves.



Health Care Is Different From Retail, Needs To Be Treated As Such

Outside of health care, people can choose whether to pay inflated prices for a patent-protected technology or minimally better products. But patients don’t have that same choice – at least not without facing potentially serious health consequences.

No doubt, patent protection for drugs and devices needs to protect the company and the investments it has made. But their economic gain must be balanced against a certain level of social responsibility. Unfortunately, that balance doesn’t exist today and change will be hard to accomplish in this current political environment.

Elected officials receive large campaign contributions from “Big Pharma,” preventing legislative change. Hospitals hype new technologies to attract more patients, even when the benefit is marginal and cost is exceedingly high. And at the first sign of resistance, drug companies spend millions on direct-to-patient advertising while continuing to wine and dine doctors (even with the implementation of the Sunshine Act, which is designed to prevent these practices).

However, there may be a flicker of hope. Recent public disclosures of new Hepatitis C medication prices have sparked national debate. Congressional leaders are starting to question drug manufacturers’ pricing schemes. And maybe this time, greed has exceeded reason. Maybe there will be regulatory backlash. But patients and employers will need to demand it.

Americans should understand that these exorbitant health care costs are not free. They come out of their paychecks and reduce the amount of public services the government can provide.

Our health care system is broken and – given the drug pipeline aimed at maximizing prices and profits – the problems will get worse if change doesn’t happen soon.

This article is available online at:

http://www.forbes.com/sites/robertpearl/2014/04/24/americas-broken-health-care-system-the-role-of-drug-device-manufacturers/

Robert Pearl, M.D.

Contributor

As a CEO, practicing physician and business school professor, I have a unique perspective on the business of health care and the culture of medicine. My passion is helping people understand the interactions and consequences of these powerful forces. I am the CEO of The Permanente Medical Group – the largest medical group in the nation – and CEO of the MidAtlantic Permanente Medical Group. In these roles, I am responsible for 9,000 physicians, 35,000 staff and the medical care of 4 million Americans living on both the west and east coasts. I am chair of the Council of Accountable Physician Practices (CAPP), a board-certified plastic and reconstructive surgeon, a clinical professor of surgery at Stanford University, and on the faculty of the Stanford Graduate School of Business where I teach courses on strategy, leadership, and health care technology. I received my M.D. from the Yale University School of Medicine and completed my residency in Plastic and Reconstructive Surgery at Stanford. Follow me on Twitter @RobertPearlMD.

Consumer App for Reporting Adverse Events to FDA!

Reporting Adverse Events? There's an App for That, But Not for Industry--Yet

Latest News | Posted: 24 April 2013

Need to report an adverse event related to a medical device? Now patients are about to find there's an app for that, US regulators revealed yesterday.   https://medwatcher.org

Background

The US Food and Drug Administration (FDA) takes in an enormous number of adverse event reports each year through various systems, including MedWatch.

One issue, however, is that manufacturers, healthcare providers and patients are held to different standards. Medical device manufacturers, for example, are held to medical device reporting regulations that require them to report to MedWatch any adverse events they are made aware of, including for off-label uses.

Patients and healthcare providers, meanwhile, are able to report adverse events, but are not required to do so.

That difference has led to significant under-reporting of adverse events according to some estimates, posing a challenge for regulators in their attempts to transition more of the regulatory assessment process to postmarket settings. If, for example, a particularly dangerous adverse event is only seen in one out of every 10,000 patients, it might not be picked up by clinical testing. Once on the market, lax adverse event reporting practices by healthcare providers could delay the time at which the company and regulators become aware of that safety issue, potentially putting more consumers at risk for a dangerous event.

A New App

That's where FDA's new MedWatcher adverse event reporting application (iOS version) (Android version) comes in, said Bill Maisel, deputy director for science and the chief scientist at FDA's Center for Devices and Radiological Health (CDRH), in a statement.

"This app allows medical device users to easily report suspected or known problems with a device from their smartphone or tablet," he said. Users in this context include patients, caregivers, and healthcare professionals, FDA explained.

Maisel later said in an interview with the Wall Street Journal that the crux of the issue for FDA was: "How can we all find out earlier than we have been finding out?"

"We'll get access to better data more quickly now," he hypothesized.

The audience the application is not to be used by is worth noting in this context: Medical device manufacturers and healthcare providers. Maisel said that these two groups, "will continue to be required to report problems through the Medical Devices Reporting System and the Medical Product Safety Network."

Indicative of Future Changes?

But as Jeffery Shuren, director of CDRH, said at the Medical Device Manufacturers Association's (MDMA) annual meeting in April 2012, the system could be a harbinger of changes to come for industry.

According to MD+DI's Arundhati Parmar, Shuren said that the MedWatcher app "will push through adverse events into the database that will replace the Manufacturer and User Facility Device Experience (MAUDE) database. “It would make it easier for aggregating adverse event reporting.”

That functionality could eventually lead to device manufacturers being given the same reporting capabilities as consumers—an outcome that seems all the more likely given that the MedWatcher app is basically just a more user-friendly version of FDA's Form 3500, according to FDA.

"We're transforming this network into a modern system that uses electronic health information," William Maisel confirmed in an interview with the Wall Street Journal.

But the idea of an app hasn't received unanimous support. Paul Ivsin, a consulting director for clinical trials, argued last week that FDA would be better served by avoiding the use of apps entirely, and instead focus on "developing a robust set of Application Programming Interfaces (APIs) that can be used by the teams who are developing medical data apps." That would result in a wider array of more customizable options to meet the needs of hospitals, manufacturers and patients, he argued. In addition, they could link up with other databases, such as the Sentinel Initiative, giving users access to more information. That would also be in line with a 2012 White House directive ordering agencies to make more data open to the public via APIs.

For now, though, FDA can only wait and see whether consumers actually use the applications. As of the time of this article's publication, the app has been downloaded more than 10,000 times.