New Drugs

Merck agrees to $58M settlement on Vioxx ads

Wed, 21 May 2008 06:59:58 -0400

Merck has agreed to a $58 million settlement with 29 states and the District of Columbia to settle allegations that it downplayed heart risks created by Vioxx in direct-to-consumer advertising. Under the terms of yesterday's agreement, Merck will submit all new TV ads for its drugs to the FDA for seven years, and follow all agency-suggested changes before airing the ads. Merck also agreed to end its practice of "medical ghostwriting," in which paid consultants or employees, rather than physicians listed as lead authors, wrote studies on Vioxx.

The agreement follows a $4.85 billion settlement, which is still pending, that ended most lawsuits resulting from findings that the drug doubled risks of heart attack and stroke. Merck withdrew Vioxx from the market in 2004.

To learn more about the new agreement:
- read this Kaiser Daily Health Policy Report item

Related Articles:
Despite safety issues, Vioxx still in demand
Vioxx defense dealt a blow by new study results
Vioxx lawsuits continue to multiply

Drug marketing spoof reminds us of real issues

Fri, 25 Apr 2008 06:59:59 -0400

In today's newsletter, we included a link to a sly pharmaceutical marketing parody for a fictional drug. The drug, dubbed "Panexa," is said to be good for patients experiencing virtually any condition, including "metabolism, binocular vision, digestion (solid and liquid), circulation, menstruation, cognition, osculation [and] extremes of emotion."

Oh, and if you prescribe this wonder drug, treat it with all due courtesy: "PANEXA should not be used to soak up spills or remove stains. This is disrespectful to PANEXA."

But patients, mind you, need have no such concerns, as it says: "PLEASE READ THIS SUMMARY CAREFULLY, THEN ASK YOUR DOCTOR ABOUT PANEXA AND HOW TO PROVIDE YOU WITH LARGE QUANTITIES."

Now, if you're anything like me, you won't be able to read the rest of this stuff without engaging in a few good belly laughs. But the writers still make some important points:

Real direct-to-consumer pharmaceutical advertising certainly has a similar "get the drug at all costs and under any circumstances" undertone, despite the professionally-scripted warnings contained in the copy.
Drug companies are happy to assume the role of adviser to patients, which arguably undermines doctor-patient relationships. ("THIS ADVERTISEMENT DOES NOT TAKE THE PLACE OF ADVICE FROM YOUR DOCTOR; RATHER, IT PROVIDES YOU WITH NEW INFORMATION ABOUT NEW DRUGS YOU COULD BE USING," it notes.)
Drug companies may not let consumers know about any side effects that pop up once a drug hits the market. (As our parodist puts it: "PANEXA can produce some notable side effects, all of which are probably really, really terrific and nothing that anyone should be concerned about, let alone notify any medical regulatory commission about." Bingo.)

Sometimes, humor offers the best way to hammer home concerns like these. Is anyone on Capitol Hill listening? -Anne

Biotechs turning to health foundations for cash

Tue, 08 Apr 2008 06:59:56 -0400

In most cases, biotech firms turn to venture capital, public stock offerings and traditional financing to fund their medical research efforts. However, in Massachusetts at least, biotechs are turning to nonprofit foundations to fund some of their research. For example, this week Epix Pharmaceuticals received about $38 million from the Cystic Fibrosis Foundation to help it find new drugs to treat the condition, contingent on meeting some of the foundation's goals. In other examples, the Juvenile Diabetes Research Foundation gave some of a recent $25 million grant round to three Boston-area biotech firms. And the Muscular Dystrophy Association has given $8.5 million to for-profits, with plans to give $1 million more to another Boston-area research house. Overall, disease-related foundations invested about $75 million in the biotech industry last year, according to industry publication CenterWatch Monthly.

To learn more about this funding approach:
- read this article from The Boston Globe
- read this FierceBiotech piece

Related Articles:
Epix Pharmaceuticals expands collaboration with Cystic Fibrosis Foundation Therapeutics. Release
Foundation invests millions to find MS drug leads. Report

ME judge nixes law limiting prescribing data access

Thu, 03 Jan 2008 06:59:57 -0500

It looks like the prescription data miners have won another victory. After successfully challenging a similar law in New Hampshire, Wolters Kluwer Health, IMS Health and Verispan have won an action blocking the state of Maine from enforcing a law limiting their access to physician prescribing information. Companies like these gather data on physician prescribing patterns, then sell it to pharmas, who use it tailoring their physician marketing campaigns. But several states, including Maine and New Hampshire, have considered or implemented laws restricting this practice.

In enacting such laws, legislators have argued that prescription data-mining and sales can lead to pharmas having undue influence over physicians, and ultimately, to increased healthcare costs due to the undue use of costly new drugs. The companies, however, have argued that restricting their access to this information violated their First Amendment rights. The decision follows the April 2007 overturning of a similar (but more restrictive) law which had been enacted New Hampshire.

To find out more about the decision:
- read this Kaiser Daily Health Policy Report piece

Related Articles:
Fight continues over state limits on prescription data mining. Report
Data providers challenge prescription-privacy laws. Report
NH bans prescription data collection by pharmas. Report
Pharmas protest NH drug info law. Report
Law would make pharmas reveal MD payments. Report

Bill giving FDA more drug safety powers could pass

Fri, 13 Jul 2007 06:59:57 -0400

With dangers from antidepressant use in children, Ketek, Vioxx and now Avandia and Actos in the news, Congress has faced some pressure to address problems with monitoring safety of new drugs. A bill giving the FDA greater power to monitor such drugs seems to be moving toward approval. This week the House approved a bill that would set up a network to scan health insurance and pharmacy records looking for potential problems with newly released drugs.

The Senate, which passed a similar measure, has joined the House in giving the FDA the muscle to make drug companies put current risk data in prescribing literature. The bills also would give the FDA the ability to demand--rather than ask--that pharmas do follow-up safety studies on new drugs. If pharmas didn't conduct post-market studies, change labels or limit distribution of treatments as ordered by the agency, they could face a $250,000 fine for one violation and up to $1 million for several violations.

While the bills are moving along, it's not clear whether President Bush will sign them. The Senate, too, could attempt to include a proposal allowing the FDA to approve generic versions of biologic drugs, which could scuttle the deal.

To learn more about the bill:
- read this Los Angeles Times article
- read this Kaiser Daily Health Report piece

Related Articles:
FDA emphasizing speed over safety? Report
FDA boosts reviews for new drugs. Report
Report faults FDA's post-marketing vigilance. Report

House mulls new pharma ad limits

Tue, 12 Jun 2007 20:01:36 -0400

Pharma lobbyists are facing new challenges this month as the House of Representatives takes on a new FDA overhaul bill which could limit consumer drug advertising. Critics have suggested that such advertising can boost spending unnecessarily, but observers--including some not on the pharmas' payroll--suggest that the ads help educate consumers about new treatment options.

The Senate version of the bill had imposed a ban on consumer drug advertising during the first two years a drug was on the market, but that provision was deleted. (Senators did approve additional FDA funding to increase the number of FDA employees who pre-review such ads, as well as giving the agency the ability to levy substantial fines for ads deemed false or misleading.) Now, pharma industry lobbyists must contend with another troublesome set of provisions, including a potential rule requiring pharmas to hold off on print, radio and TV ads for three years for drugs with the potential for serious harm.

To find out more about the measure:
- read this article in The Boston Globe

ALSO: FDA critics offer data on "cozy" industry ties. Report

Related Articles:
FDA boosts reviews for new drugs. Report
IOM slams FDA, calls for major reforms. Report
Report faults FDA's post-marketing vigilance. Report
FDA emphasizing speed over safety? Report

FDA emphasizing speed over safety?

Mon, 11 Jun 2007 20:01:35 -0400

On the one hand, everyone would like to see potentially beneficial drugs approved as soon as possible. On the other, no one wants to see the FDA speed heedlessly through the approval process either. As scandals blow up on Capitol Hill over Avandia and other drugs, critics are beginning to question whether the FDA is striking the right balance between speed and safety. Evidence increasingly suggests that the FDA has a habit of silencing internal and external critics--and that safety may be too low on its list of concerns, according to a New York Times analysis. With researchers pointing to dangers from antidepressant use in children, Ketek, Vioxx and now Avandia and Actos prior to the FDA's taking any action, some Congressional players are wondering whether they should crack down on the agency.

To learn more about the ongoing debate:
- read this piece in The New York Times

Related Articles:
Avandia critic: FDA launched smear campaign. Report
FDA boosts reviews for new drugs. Report
IOM slams FDA, calls for major reforms. Report
Report faults FDA's post-marketing vigilance. Report

Health plan association backs monitoring agency

Sun, 22 Apr 2007 20:01:35 -0400

How often do you see the insurance industry petition the government to set up another federal agency? Well, in this case, this most unlikely of events has actually occurred. America's Health Insurance Plans (AHIP), the association representing health insurers, has asked Congress to create an agency dedicated to comparing the effectiveness of existing medical treatments, drugs and devices with new ones. (It would be intriguing to see whether some doctors' instincts are correct that snazzy new drugs pushed by reps aren't really better than the old standbys.) The association is suggesting that the new agency be funded and managed by both the federal government and the private sector. AHIP would like to see these effectiveness measures performed both before and after FDA approval is granted. As part of its request, AHIP is also asking Congress to create state medical dispute resolution boards which would screen medical malpractice claims--as well as claims against health insurers for provider negligence, natch--and toss out those without merit.

To learn more about AHIP's initiative:
- read this report from the Daily Health Policy Report
- read the AHIP press release

ALSO NOTED: UnitedHealth offers real-time claims submissions; CA considers health insurance rate regs; and much more...

Thu, 12 Apr 2007 20:01:30 -0400

> UnitedHealth has created a new claims submission website allowing physicians to file claims in real time. The health plan says the system can confirm patient costs within 10 seconds. Article

> A group of California lawmakers and consumer advocates are pushing for state regulation of medical insurance rates, similar to rules that already govern auto insurance. Article

> Medicare plans to pass out $30 million to states to develop programs to counsel beneficiaries. Article

> Military officials are considering closing Walter Reed Army Medical Center as soon as possible, rather than waiting until 2011 as planned. Article

> Analysts are predicting that the HIV medication market will grow to $10.6 billion by 2015, driven partly by new drugs such as Pfizer's CCR5 inhibitor Celsentri and Merck's integrase inhibitor Isentress. Article

> The U.S. Senate has passed two bills that would increase federal funding of stem cell research. Report

And Finally... They don't come better connected than Tenet's newest board member. Article

FDA rule would limit role of industry advisers

Wed, 21 Mar 2007 20:01:37 -0400

Doctors taking more than $50,000 from a drug or medical device company would be banned from voting on approval for that company's products if a new FDA rule becomes final. Physicians with such strong financial ties to a company whose products are under consideration--or ties to a competitor--would not be allowed to serve on the committees that make approval decisions. This represents a significant change from existing rules which, while they bar advisers holding $100,000 or more of stock in the company being discussed, could otherwise have accepted essentially unlimited funds. Agency officials have said that the new rules will affect a "significant number" of its current advisers. The new rules are intended to respond to charges that the agency's approval process is unduly influenced by the drug and device manufacturers it regulates.

To learn more about the proposed rules:
- read this article from The New York Times

Related Articles:
Pharma disclosure laws not working. Report
FDA boosts reviews for new drugs. Report
IOM slams FDA, calls for major reforms. Report
Report faults FDA's post-marketing vigilance. Report