medical device

iPod, iPhone, iPill?

Christe Bruderlin-Nelson — Wed, 12 Nov 2008 01:51:09 -0500

Philips electronics is touting its latest invention: a programmable drug capsule the size of a multivitamin that can target its site of action in the body.

The battery-powered gizmo has a microprocessor in it and can release the proper dose of a given drug at the intended place, preventing exposure to the medicine at other parts of the body, the company claims. The iPill will take in and transmit (via a wireless transmitter) information about temperature and pH as it travels through the gastrointestinal tract. When the parameters are just right, a microprocessor turns on a tiny drug pump, which releases the drug.

Another company in Israel had already developed a pill with a camera, which physicians can use to look around the gastrointestinal tract. The new pill is the same size, but Philips might be able to make it even smaller in the future.

What isn't so small? The cost. The pills will likely cost around $1,000 a pop.

Philips is a Dutch company that makes cordless phones and Web cams. The company is currently in talks with drug companies about its prototype, which it is touting for use in the treatment of colon cancer and bowel inflammation.

- read the story in the San Francisco Chronicle

NYT: Devices get cursory FDA scrutiny

Tracy Staton — Mon, 27 Oct 2008 11:27:34 -0400

Over the past few years, repeated drug-safety scandals have plagued the FDA, putting the agency under fire for its performance as the nation's drug watchdog. Now, the FDA's device-approval division gets to share the pain. According to the New York Times, the agency lets thousands of new devices onto the market every year via its fast-track review program, often with little evidence that they actually work to help patients.

The FDA told the NYT that quickly reviewing devices helps promote innovation. Also, the agency said, many devices are simply incremental improvements over old devices, and as such require no full review. Requiring drug-style trials of these devices would be a bad use of resources, the FDA's director of devices and radiological health told the paper.

Under a fast-track review, a product's clinical effectiveness isn't established. Instead, regulators determine whether the device does what the manufacturer claims it will. In the case of MammoSite, a "seeding" radiation device for breast cancer treatment, the agency only tested whether it delivered radiation, not whether it works as well as conventional radiation at preventing a cancer recurrence.

Soon, we'll have more information to evaluate the agency's performance in this area: Prompted by Congressional questions about the FDA's regulation of devices, the Government Accountability Office will release a report later this month.

- see the New York Times article

Justice probes biliary stent marketing

Tracy Staton — Tue, 05 Aug 2008 10:39:02 -0400

The U.S. Department of Justice has launched a probe of the bile-duct stent market, trying to determine whether companies such as Abbott Laboratories, Boston Scientific and Johnson & Johnson improperly promoted the devices. The U.S. Attorney's Office in Massachusetts has been subpoenaing stentmakers about their marketing practices, according to SEC filings. The companies have reported that Justice wants to know whether they've promoted the biliary stents for other uses, such as propping open leg arteries.

The U.S. Attorney's office wouldn't comment on the investigation, and the companies themselves wouldn't either, beyond saying that they're cooperating.

- read the Dow Jones story at CNN Money

Zimmer device prompts database push

Tracy Staton — Tue, 29 Jul 2008 10:51:45 -0400

Last week, Zimmer suspended sales of a hip-replacement device after doctors complained that some patients found the joint socket extremely painful. This week, experts are calling for a national artificial joint database to catch such problems earlier. Report

Reps introduce anti-preemption bill

Tracy Staton — Fri, 27 Jun 2008 10:18:03 -0400

They said they would, and now they have: two Democratic Congressmen have introduced a bill that explicit allows consumers to sue medical device makers under state law. You'll recall that in February the U.S. Supreme Court ruled that patients injured by defective devices can't sue because the FDA's approval preempts state law. The ruling angered some congressional reps, who said that lawsuits play an important role in keeping companies honest and protecting patients. So, they've put together the Medical Device Safety Act in the House; a companion Senate bill is set for introduction by Sen. Ted Kennedy and Sen. Patrick Leahy.

This bill doesn't affect drugmakers; pharma companies, unlike device makers, aren't covered by a statute that implies preemption. But the Supreme Court is expected to rule in a pharma preemption case this fall. We'll have to wait and see what that ruling is--and whether Congress might step up to reverse it, too.

- read the Pharmalot item

ALSO: Medtronic announced that William A. Hawkins, the company's chief executive, has been named to the additional position of chairman, effective August 21. Report

Boston Sci CEO plans to stick around

Tracy Staton — Tue, 03 Jun 2008 11:00:56 -0400

Tobin, Tobin, he's our man. Or so says Boston Scientific. The device maker says chief executive Jim Tobin will be "extending his tenure," planning to stay with the company "for the foreseeable future." The only difference is that now, Tobin will be more focused on day-to-day operations; since the acquisition of Guidant in 2006, Tobin has been working to integrate the two companies. He'll have to be more operations-focused, we suppose; COO Paul LaViolette is retiring, and he won't be replaced.

The CEO announcement comes just days after a federal jury in Texas ruled that Boston Scientific infringed on three Medtronic patents covering stent technology. The company plans to argue its side of the case--using some defenses that weren't presented to the jury, for some reason--before a judge on July 31.

- see the article in the Boston Globe
- read the CNN Money piece
- check out the Boston Herald story on Medtronic's patent

Zimmer mulls $250M in doc-contract buyouts

Tracy Staton — Mon, 19 May 2008 11:15:48 -0400

You've heard of sports teams buying out their coaches' contracts. Well, now there's a device maker considering buying out its deals with surgeons. In a move designed to clear up legal troubles over its contracts with doctors, Zimmer is considering cutting off royalty contracts with many of them. To get out of those long-term deals, the company would give those docs up-front payments. Though Zimmer won't say how much that's likely to cost, analysts estimate the buyouts might run to $250 million.

And that would come on top of a $169.5 million fine levied by the U.S. government last year, plus the $54 million Zimmer expects to spend on new compliance measures, such as disclosing doc payments in an online database.

- read the story in the Financial Times

Related Article:
Zimmer weeds out doc conflicts

GAO assails FDA's foreign inspections

Tue, 29 Jan 2008 06:59:58 -0500

Oh, woe is the FDA. The Government Accountability Office is set to release a new report on the agency's terrifically inadequate inspection record overseas. According to the New York Times, which obtained a copy early, the FDA is so understaffed that it would need at least 27 years to inspect every foreign medical device plant and 13 years to check every foreign drug plant. Think that's bad? Catching up on food inspections would take a mind-boggling 1,900 years.

Most disturbing is the fact that the agency is farthest behind in--you guessed it--China, that bastion of impure and unsafe exports. China has more drug and device plants than any other foreign nation, and FDA inspections there are few, the Times notes.

The GAO will present this bad news at a hearing before the House Energy and Commerce Committee, which has been dogging the FDA for months now. One witness set to testify said, "This is a fundamentally broken agency, and it needs to be repaired." We advise the FDA to focus on the "repair" part of that sentence. Today will be painful, sure, but it could lead to a sorely needed increase in funding. If the stars and politicians line up just right, that is.

- read the article from the New York Times
- here's the witness list (.pdf) for today's hearing; find a link to the webcast

Supreme Court to hear Pfizer liability case

Wed, 26 Sep 2007 06:59:58 -0400

Do states have any business policing drugs? We're about to find out. The Supreme Court has agreed to hear Pfizer's appeal in a product liability suit originally brought in a Michigan court, but thrown out because of a state law limiting lawsuits over FDA-approved drugs. The suit concerns Rezulin, a Warner-Lambert drug pulled from the market for liver side effects just as Pfizer bought that company.

That court waved off the Michigan law's sole exception--that it's OK to sue in state court when a drug maker misrepresents info presented to the FDA--by saying that federal law pre-empted it. The U.S. Circuit Court disagreed and reinstated the suit.

Now, the Supremes will have their say--and legal experts say they might be inclined to agree with Pfizer, which wants product liability cases to be restricted to federal courts. The top court has also agreed to hear a case whose central issue is whether federal approval of a medical device--in this case made by Medtronic--shields it from liability claims under state law.

- read this article in the Houston Chronicle

Related Articles:
Big pharma claims Supreme victory. Report
Supreme Court debates patent law. Report

Stent-makers get more bad news

Tue, 28 Aug 2007 06:59:58 -0400

Go ahead, kick them while they're down. Britain's National Health Service may stop paying for drug-coated stents, products that already are suffering from safety-related fears. The National Institute for Health and Clinical Excellence (NICE) will meet next week to review the proposal, which cites the huge difference in price between drug-coated stents ($2,300) and the uncoated versions ($700). British cardiologists are fighting the measure, saying that drug-coated stents are still the best option for some patients.

Facing a market that's expected to shrink by $1 billion this year, leading makers of the drug-coated devices--Johnson & Johnson and Boston Scientific--have been retrenching by cutting costs and jobs. A NICE rejection? Insult to injury, especially for the thousands more who might get pink slips.

- read the report from the Boston Herald

Boston Scientific deals with debt

Fri, 24 Aug 2007 06:59:57 -0400

No need to sell the farm--or at least not all of it. Embattled medical device maker Boston Scientific made a $1 billion loan payment and restructured some of its other debt, giving itself a breather on a long uphill road back to financial health.

Boston Scientific has a steep climb to make. Last month, Moody's cut its bond rating to "junk." The company's stock is trading at a five-year low. It's carrying billions in debt. And its core business is shaky; stents have come under fire recently for failing to beat cardiac drugs at preventing future heart problems. Now, the company is looking to cut jobs, and possibly sell three of its businesses, which could raise $500 million to $600 million.

- see Boston Scientific's release
- read the report from The Boston Globe

Related Articles:
Tough times for stent market. Report
Stent study surprises. Report
Decline in drug-coated stent use at cardiac centers. Report
Insurers may cut stent payouts. Report