This spring, the U.S. Supreme Court faces several decisions that will impact millions of people: legal challenges to the Defense of Marriage Act (DOMA) and the Voting Rights Act, for instance. But another case getting less media attention will affect all Americans who pay health care premiums or taxes.

The Supreme Court will decide whether the increasingly frequent practice of brand-name drug companies paying off their competitors to keep new generics off the market is a violation of antitrust law. As former Federal Trade Commission (FTC) attorney David Balto told Politico “There’s no other case that can have as much impact on reducing health care costs.”

This practice, called “pay-for-delay,” has skyrocketed since an appeals court decision allowed the first such deal in 2005. Since then, over a hundred pay-for-delay deals have delayed generic versions of 20 to 30 brand-name drugs each year, according to federal regulators at FTC.

There is no question delaying access to generic drugs harms consumers. That’s why Community Catalyst has helped consumers and advocacy organizations join legal challenges to pay-for-delay deals that blocked consumer access to generics of Provigil, K-Dur and Tamoxifen for years. We have also filed or joined Amicus briefs, and organized national and state-based advocates calling on Congress to ban pay-for-delay agreements.

Recently, Politico ran another story about how one defendant drug-maker in the case (Solvay Pharmaceutical) claimed that these pay-for-delay agreements don’t harm consumers, a position echoed by the generic drug industry’s trade group GPhA. But the FTC, U.S. Department of Justice, Attorneys-General in 36 states and consumer advocates all disagree. Why? Because access to generic drugs brings big savings for consumers and health plans. Look at GPhA’s own data that estimates access to generic drugs has saved consumers and our health care system more than $1 trillion from 2002 to 2011. That’s because generics cost one-fifth to one-tenth as much as brand-name drugs.

How the System’s Supposed to Work

Traditionally, generic drug companies wait for the patent on a brand-name drug’s active ingredient to expire and then file an application with the FDA to bring the generic version of the drug to market. Then the brand-name drug company sues the generic drug company, claiming some “patent infringement.” But in nearly all cases, the drug itself is off-patent. So the infringement is of a “secondary” or “defensive” patent that addresses some minor detail, like how the drug is formulated into a pill, or some step in the manufacturing process. The generic drug company then defends themselves from the litigation, and if they win, they launch their generic right away.

How Pay-for-Delay Deals Broke the System

Since 2005, generic and “BigPharma” companies have decided to do what the federal and state anti-trust regulators see as collusion. During litigation, the brand-name drug company offers to settle the patent infringement lawsuit they filed by paying tens or even hundreds of millions to the generic company, which then agrees to not to start selling a generic for several years. Pay-for-delay settlements are very suspicious, not only because they are made in secret but also because the payments are going the wrong way. Usually the patent-infringer is forced to pay if they violate someone else’s patent. But in these pay-for-delay settlements, these roles are reversed.

For example, Bayer sued four generic manufacturers, saying, in essence:  You have infringed the patent on our blockbuster drug Cipro. To show you how angry we are, we will pay you 400 million dollars. But only if you stay off the market.

As a result, consumers did not have a generic version of the antibiotic Cipro for another seven years, while Bayer made billions in unfair profits. Overall, these so-called settlements have caused consumers and their health plans to pay tens of billions right into the pockets of the brand-name drug companies. This creates a powerful incentive to collude and delay competition as long as possible. For the millions who are underinsured, delaying a generic can force patients to pay thousands of dollars a year, or go without needed medicine.

One story we collected from a consumer from Kansas describes his struggle to afford Provigil, whose generic was delayed from 2006 to 2011 by pay for delay. He reported: “[Despite] paying almost $17,000 in annual premiums for my family [health insurance plan] last year, I was paying around$650/month [for Provigil]… That is out of pocket money I have to come up with until later in the year when I reach my deductible [sic] and I can enjoy a few months of only paying $60/month. I cannot describe to you how much stress and difficulty this has caused for me and my family the last several years…”

The real question is whether the high court will allow these secret deals and legal maneuverings to continue? Or will it restore legitimate competition to this market, lowering health care costs and ensuring better access to affordable medicines for all Americans?

Stay tuned. We will be blogging regularly about this case as it unfolds and calling attention to how pay-for-delay deals harm consumers and increase the cost of health care.

A significant vote by the Senate Appropriations Committee last week has focused renewed attention on vital cost-saving reforms on prescription drugs that failed to make it into health reform. At issue is the drug industry practice of paying off generic competitors of expensive brand-name drugs to delay access to low-cost generics. Community Catalyst has opposed this practice through our advocacy and with consumer class action lawsuits through our Prescription Access Litigation project.

How serious are these multi-million dollar sweetheart deals that prevent consumer and health system savings? The Federal Trade Commission, the federal government’s consumer protection watchdog, reported in January that these agreements delay the entry of generic drugs into the market by an average of 17 months. Given that generic entry can reduce the price of branded drugs by up to 90 percent, the FTC estimates conservatively that the cost of these delays is at least $3.5 billion in lost savings per year.

Through these pay for delay deals, the brand-named drug manufacturer gets to continue to be the exclusive seller of the drug and the generic manufacturer makes money for not bringing a generic (non-patented) version of the drug to market. It is then left to consumers and the government to pay the price for the high drug costs that result from these agreements.

21 new pay-for-delay deals in 2010 may cost consumers and the health care system $9 billion

The FTC warned in recent Congressional testimony that pay-for-delay agreements are becoming more common and have reached the point of being “almost an epidemic” (see graph). Deals rose from only three in 2005 to 19 last year and 21 in the first nine months of 2010. This dramatic increase followed court decisions since 2005 by a few appellate courts that, according to FTC, “misapplied the antitrust law” to uphold these agreements as not anticompetitive.

The FTC’s preliminary analysis of the 21 agreements filed this fiscal year concludes that they cost $9 billion in lost savings. Past pay-for-delay agreements to date are estimated by FTC to cost all public and private purchasers at least $20 billion — an estimate that may rise given the current spike in agreements. FTC estimates that these settlements cost consumers and our health system at least $3.5 billion a year, while other experts suggest that the potential total savings could be closer to $12 billion a year if pay-for-delay settlements were ended.

The federal government — and health reform sustainability — would benefit greatly from banning these agreements. The Congressional Budget Office estimated the savings to the federal government alone of around $2.6 billion over the next ten years.

Legislative History

A bill to ban these agreements was included in the House’s health care reform proposal last fall. Unfortunately, though a similar measure was supported by the White House and considered by the Senate, the procedural and jurisdictional rules in the Senate kept the measure from being included in the national health reform bill enacted last March.

House leaders were undeterred by this set-back and added language banning these deals to an appropriations bill approved on July 1st. Unfortunately, the Senate went on to strike this provision from an appropriations bill they subsequently approved. But two weeks ago, the bill’s longtime advocate, Senator Herb Kohl (D-WI), along with Senator Richard Durbin, succeeded in including this provision as an amendment to the Senate’s Financial Services and General Government Appropriations Act.

On July 29th, an effort by pharma to strip this provision was narrowly defeated in the Senate Appropriations Committee. Senator Arlen Specter (D-PA) had introduced an amendment to strip the provision from the Committee bill, and when four other Democrats voted with Specter, the Associated Press reported that:

“Drug company lobbyists in the audience thought they had the vote won, provided they could win over every panel Republican. But Sen. Richard Shelby, R-Ala., voted against the drug companies, helping give Kohl and Durbin [the author of the Appropriations Bill] a surprise win.”

The successful Senate Committee vote signaled to FTC Chairman Leibowitz that “the tide may be turning,” and that “consumers are one step closer to saving billions on their prescription drugs.”   The bill’s Senate sponsor, Senator Kohl, pointed out why this decision can’t come soon enough:

“The cost of brand-named drugs rose nearly 10 percent last year. In contrast, the cost of generic drugs fell by nearly 10 percent. At this time of spiraling health care costs, we cannot turn a blind eye to these anticompetitive backroom deals that deny consumers access to affordable generic drugs.”

This recent vote is a crucial step. The potential savings to both consumers and the government is substantial and is particularly important in these turbulent financial times. A New York Times editorial this week emphasized that these potential savings “would reduce the federal deficit by $2.6 billion over the next decade, freeing up money for worthy programs that would otherwise be cut.”

Why should we allow these agreements to continue to the financial benefit of only a small subset of the U.S. population when the savings that would result from banning these agreements could benefit a far greater number of individuals? It is about time for the pay-for-delay settlement to meet its long-awaited demise.

The final vote in Congress on the Appropriations bill will likely come sometime after the election. It will take vigilance and aggressive action by supporters to combat PhRMA’s tactics again — just last week they released a new report disputing the FTC analysis. But in Pharmalot, an FTC representative states: “The pharmaceutical industry can fund as many studies as it wants, but it can’t change the facts — these pay-for-delay deals cost consumers $3.5 billion a year.”

– Emily Cutrell, legal intern
– Wells Wilkinson, Director of Prescription Access Litigation project

Last week’s article by New York Times reporter Gardiner Harris exposed Glaxo SmithKline’s (GSK) flagrant disregard for patient safety. For 11 years GSK suppressed internal studies showing that the world’s former best selling diabetes drug, Avandia, posed a much higher risk of heart attack than its main brand-name competitor, Actos.

Last Wednesday, an FDA advisory review panel concluded a two-day hearing by recommending 20 to 12 that Avandia remain on the market with label revisions and other restrictions. This deeply divided panel included 17 votes to add warnings or restrictions on the drug, and 12 votes to remove the drug from the market.

The members voting for Avandia’s removal said the drug “has no unique benefits and therefore the benefits of the drug do not outweigh the risks.” They also pointed out that Avandia’s primary competitor, Actos, is an acceptable alternative to Avandia and therefore there is no therapeutic necessity to keep Avandia on the market.

Even the use of Actos has been called into question. Harvard researchers based at the Independent Drug Information Service (www.RxFacts.org), note that “in mid-2007 the FDA added black-box warnings cautioning that both rosiglitazone (Avandia) and pioglitazone (Actos) increase the risk of congestive heart failure. These safety concerns, along with an increased risk of fracture, have greatly dampened enthusiasm for use of both of these drugs.

The ultimate fate of Avandia now rests in the hands of the FDA. If the proposed additional warnings and restrictions are implemented, scientist Steve Nissen, who published the first study documenting the cardiac risks of Avandia in 2007, estimates that 95 percent of Avandia’s use will end. “Effectively, this drug is gone.”

Interestingly, the committee also recommended by a vote of 19-11 that the trial currently underway comparing Avandia to its rival Actos be continued, though at least one member questioned the ethics of this, given the potential risks.

The Phantom 1999 Study

We now know that GSK conducted a 1999 study comparing Avandia to its main competitor, Actos, that linked Avandia to a 43 percent increased risk of heart attacks. GSK never reported these findings to the FDA. An email from Dr. Martin I. Freed, a GSK executive at that time said:

Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK.

When another GSK official asked whether this trial and another negative study should be published, Freed responded: “Not a chance. These put Avandia in quite a negative light… [W]e would hope that these do not see the light of day.”
Other company documents reveal that in the 1990s, GSK decided against doing another study to determine definitively whether Avandia caused heart attacks because it feared that the results might hurt sales.

Litigation yields access to studies, helps expose risks

GSK’s earlier suppression of studies showing risks associated with the anti-depressant drug Paxil led to litigation and settlements that required GSK to post information online about all their clinical trials. Using this and other information, researchers Nissen and Kathy Wolski of the Cleveland Clinic published in 2007 an analysis of over 40 studies showing that Avandia increased the risk of heart attack, stroke and death in comparison to rival drug Actos.

GSK responded to the Nissen study by publishing results from their own  six-year ‘RECORD’ study. At the time, GSK asserted the RECORD study proved that Avandia posed no increased risk of heart attack or death. But reviewers have found a dozen serious incidents were excluded in the total tally of adverse events from the RECORD study. According to one FDA reviewer, “deaths that occurred while taking Avandia were inexplicably dropped from the final analysis.” Now GSK’s possible role in manipulating the RECORD study to keep their drug on the market is in question.

New evidence, studies bring risks to light

Ongoing investigations by Senator Grassley and almost a dozen new studies documenting the risks of Avandia have kept the issue alive, prompting the FDA’s ongoing review, including last week’s hearing.

One comparative effectiveness study by David Graham of the FDA was published this past June. Graham worked with researchers at the Centers for Medicare and Medicaid Services to collect records from nearly a quarter million Medicare recipients.  Elderly diabetics, who used Avandia instead of its competitor Actos, had a 68 percent increase in the risk of heart attack, stroke, heart failure or death. Graham stated:

We estimate that about 48,000 excess cases of [heart attack], stroke, heart failure, or death were attributable to the use of [Avandia] rather than [Actos] from 1999-2009.

Graham additionally stated “the RECORD study would have been dismissed as ’garbage’ if it had been used to seek the drug’s original approval.”

What’s next?

Whether the FDA will allow Avandia will remain on the market is still in question.  Beyond that, what else can we do to stop such illegal and hazardous industry behavior – the same behavior that resulted in the Vioxx tragedy, which led to up to 60,000 deaths? Litigation and other sources have revealed the suppression of drug risks concerning Vioxx, Paxil, Celexa, Zyprexa, and many other drugs. The problem seems endemic.

To begin to address this problem, FDA needs the resources and authority to examine all relevant clinical studies for data-tampering. Government and private consumer lawsuits must continue, including possible criminal prosecution. Finally, we should all remember that what you read on your drug label or hear in a TV ad may not be the whole story. Skepticism is warranted and further regulation is critical to all of us – we need medical care we can trust.

– Emily Cutrell, Prescription Access Litigation

Today, over at the PAL blog: the ban on pay-for-delay generic drug settlements which just passed out of the Senate Judiciary Committee, what it could mean for patients and insurers, and how the Senate and House versions would work.

Here’s more at Reuters.

Does “a wealth of data from independent studies,” show that direct-to-consumer advertising of prescription medications “has a positive impact on public health”? That’s the claim from Pfizer in its recent submission to the FDA. But their evidence ain’t much.

Our own submission, filed jointly with Prescription Access Litigation, cites a systematic review by Gilbody et al. The authors evaluated 2800 DTCA-related publications, finding only four that met strict criteria for quality of study design (most available DTCA data comes in the form of consumer and physician surveys). And none of the four studies demonstrate a public health benefit from DTCA; they in fact raise some concerns.

Pfizer references eight citations in its submission. But it turns out that four of those were consumer surveys focused mainly on awareness and perception, and two others were earlier testimony from Pfizer and PhRMA to the FDA. One was a General Accounting Office report warning (Pfizer neglected to mention this) that “DTC advertising prompts millions of consumers to ask their doctors for prescriptions for specific brand-name drugs. As a result, it is important that FDA act effectively to minimize the public’s exposure to misleading DTC advertisements.”

In the one study put forth by Pfizer from a peer-reviewed journal, patients were asked what had happened when an advertisement prompted them to ask their doctor a question.  It turns that about a quarter of these patients ended up with new diagnoses (a substantial minority of which were for “high priority” conditions). There were some methodological limitations, but the bottom line is that not even the study’s authors concluded that DTCA produces public health benefits.

There may or may not be free speech grounds for allowing DTCA. Based on this evidence, there surely isn’t a public health case.

To view the full docket, follow this link.

PostScript goes to the Hill this week, where the Senate Aging Committee held a hearing on academic detailing, the practice of providing doctors with unbiased, evidence-based drug information to counteract pharmaceutical sales pitches.  The hearing was held in anticipation of legislation from Sens. Herb Kohl (D-W) and Richard Durbin (D-IL) to build a federal academic detailing program.

According to the BNA Health Care Daily Report, “The Kohl-Durbin proposed academic detailing legislation would provide grant money to public entities…for hiring academic detailers who would provide educational materials at doctors’ offices and conferences.”

Among those who testified were Dr. Jerry Avorn, a Harvard Medical School professor and lead of the Independent Drug Information Service in Pennsylvania; Sharam Ahari, a former drug-rep who now educates about insider tactics of sales reps; and Allan Coukell, policy director of the Prescription Project.

The BNA also reported that a Senate committee aide called the bill a cost-saver and anticipated strong bi-partisan support.  Read the Prescription Project report on the cost-effectiveness of academic detailing here.

More coverage in the Wall Street Journal Health Blog, ABC News, and Medical News Today.

Good day, Sunshine

And yesterday on the other side of the Hill, Reps. Peter DeFazio (D-OR) and and Pete Stark (D-CA) announced a companion bill to the Senate’s Physician Payments Sunshine Act.  Both bills would require drug and medical device companies to disclose payments to physicians twice yearly in a centralized and public online database.

The Prescription Project is a member of the National Coalition on Medicine and Marketing, which supports both bills. Read DeFazio and Stark’s news release here.

Data-mining bill falls in Evergreen State

The Washington state legislature came close to passing a data-mining bill that would have prevented the commercial use of prescriber data in that state, but fell a few votes short at the close of session.  To find out more on what happened, check out Kate Petersen’s interview with state Rep. Jamie Pedersen at the NLARx website.

Firms settle in drug-pricing case

And news of a third settlement in a 2002 drug-pricing class action lawsuit came this week.  Plaintiffs were awarded $125 million in the case, which alleged that drugmakers artificial inflated the Average Wholesale Price, used by many public and private payors to set drug prices.  Read all about it at the PAL blog.

This week, drug giant Merck is out $671 million in combined settlements in one whopper of a health care fraud case.  Prosecutors for the states and federal government alleged that the maker of Vioxx and Zocor overcharged 49 states and the District of Columbia for four popular drugs, and bribed doctors to prescribe them with kickbacks disguised as consulting fees.

Read AP coverage here.

Row Row Row…Whose boat?

We admit, in the shadow of bribery, fake-rowing seems like a little white lie, but it’s one that may have turned into big bucks for Pfizer, the maker of Lipitor.   A month ago, Dr. Robert Jarvik, the Lipitor frontman that gives millions of primetime viewers the heebie-jeebies during commercial breaks every night, was outed for never having actually practiced medicine.

Now, courtesy of some digging by two Michigan House Democrats, it turns out Jarvik doesn’t row, either, as he’s seen doing in a recent Lipitor commercial (even though his stunt double’s on the team.)

Congress must decide whether the American public was more fooled by Jarvik’s doctorness or his rowing prowess, and why back in 1997 permitting pharma to run TV ads seemed like such a good idea.

Check out the PAL blog’s ideas for Jarvik’s replacement.

Industry-free CME at Sloan-Kettering: a case study

The Carlat Psychiatry Blog found this article in Medical Meetings Magazine on how Sloan-Kettering Memorial Cancer Center in New York cut industry out of its CME curriculum.

Some seemingly simple steps were taken to make up for the 25 percent of industry funding the center turned back:  Conference organizers used more cancer experts already in-house, moved the meetings from hotels to the conference center on campus, cut out catered lunch, and reduced advertising in mailers and medical journals. According to officials at the world-renowned cancer hospital, response has been positive and attendance steady. 

Vanderbilt gets on gift-ban bandwagon

Vanderbilt University Medical Center has banned gifts from pharmaceutical and devicemakers, an announcement that comes in the wake of news that the vice chancellor of health affairs was appointed to the board of Merck.

According to the Fairview Observer, the policy does not affect researchers, only clinicians, and there is no provision for oversight or penalties.

[Yeah, but who wants to anger Commodore Cornelius?]

Between the lines

Gooznews had his reading glasses on for this one:  a sentence in a New York Times story about spine device researchers who invest in the technologies they test.  Count me in, says Goozner, among the “few [who] would argue that doctors should never be allowed to invest in new technologies.”

“Why draw the line at research?” Goozner writes. “Is it okay that the doctor prescribing a particular drug has a huge hunk of his or her retirement portfolio in the stock of the company that makes that drug?”

What Would Nightingale Do?

Without much formal conflict-of-interest training or guidelines, nurses are prime targets and perhaps the next frontier for pharmaceutical detailing, according to this new article in PLoS Medicine.

Portrait Gallery

A nice profile on RxP ally, AMSA PharmFree coordinator, and Tar Heel of the Week Anthony Fleg appeared this week in the Chapel Hill News and Observer.

And the New Jersey Business Journal interviews state Attorney General Anne Milgram.  There are ten questions, but they all fall under the general category : “Why you gotta be so mean to pharma?”

State Round-up

This Charleston Gazette piece looks at the debate around a law recently passed in the West Virginia legislature that would require pharmaceutical companies to disclose all gifts to physicians to a state-wide board.

Pharmalot reports that New York State Senator Tom Morahan has asked the state health commissioner to look into a report that NY Medicaid spent $82.8 million on psych drugs for kids in 2006, many of which were off-label.

The Vermont legislature still stands behind the prescription data confidentiality law it passed last spring, according to a vote on a motion to repeal the embattled law at the state house this week.

Vermont was sued by health information companies who sell the data and awaits a trial in May.  A similar 2006

New Hampshire law was overturned by a district court judge and awaits decision by the  U.S. Court of Appeals.

From the Oops department… Covetous reporters, critics of pharma and all those ever bested by office culture had a good laugh this week after the leak of top secret documents related to Eli Lilly’s high-stakes Zyprexa negotiations to a lucky New York Times reporter was linked back to an error by a Lilly lawyer who used the auto-fill in his email headings one too many times. The docs were supposed to go to Bradford Berenson, Esq., but the unintended recipient was none other than Times pharmaceutical reporter Alex Berenson. Pharmalot has more here.

From the Let the Good Times Roll department…

Comes a good post from the New Orleans-based National Physicians Alliance doc, alias KidShrink, who made a point of speaking up and saying ‘not cool’ to a pharmaceutical Rep-Elf stuffing physician mailboxes with branded trinkets. Queen of England and King cake, all in one post.

…but landed the folks behind “Money Talks: Profits over Patient Safety” on the list of ”2008 Notable Video for Adults” by the American Library Association Video Roundtable Committee.   

Among the stars of the Kathleen Slattery-Moschkau’s documentary on pharmaceutical marketing, Prescription Access Litigation’s own Alex Sugerman-Brozan.  We’ve got an ear out for the Oscar buzz. 

You can find out more about the award and the documentary at Prescription Access blog. 

Well, the RxP Weekly Reader is back and ready for a busy year of news and comment on pharma and medical conflicts of interest. But there’s a few things that happened at the end of the last one that need mention before we dive fully into 2008…

UMass Medical Center clamps down on industry ties

UMass Memorial Medical Center (UMMMC) just introduced tough conflict-of-interest policies to limit industry influence on faculty working at the Worcester campus.

The new rules, which the Prescription Project helped the medical center develop, prohibit faculty from accepting all gifts, including vendor-bought meals on and off-campus, from participating in speaker’s bureaus for industry, and from serving on the hospital’s P&T committee if they have a financial relationship with a drug or device company.  The policies are being lauded as some of the toughest in the nation.

Read more in the Boston Globe, Medical Marketing and Media, Health Care Renewal, and this editorial in the Springfield Republican.   To read more about the Project’s recommendations for academic medical centers, go here.

Alms for the poor, but samples?

Not so much. That’s the contention, at least, of a forthcoming study by researchers at Harvard Medical School and Cambridge Health Alliance, who found that the overwhelming majority of free samples go instead to wealthy or insured patients.

The study, based on a survey of 33,000 Americans, found that just 28 percent of those who reported receiving samples from their physician were poor, and only 18 percent were uninsured for part of the year, statistics that work against the myth that samples primarily aid poor or underinsured patients. The study will be published in the February edition of the American Journal of Public Health.

Read more at USA Today, The Boston Globe, Modern Healthcare (subscription required), Prescription Access Litigation blog and Kaiser Daily Health Policy Report.

“The Cost of Pushing Pills” in PLoS

This analysis in PLoS Medicine uses a new source of industry data to estimate that pharmaceutical companies spend twice as much on marketing as they do on research and development.  The metric, which combines data from IMS Health and research group CAM, is bolder than previous numbers compiled from IMS data that have also suggested that when it comes to pills, the free pen is mightier than the pipette.

In this week’s American Medical News, there’s an excellent ethics opinion piece on physician disclosure and whether it would solve conflicts of interest in medicine.  A researcher and physician each take their turn; one argues that voluntary physician disclosure of gifts to patients would improve patient confidence; the other says disclosure is a false fix for a plainly unethical practice, and anyone who does accept gifts is a “compromised healer.”

District Court strikes down Maine’s data-mining law

As newsrooms emptied and shopping malls filled before Christmas, Bangor district court judge John Woodcock struck down that state’s law, which permitted physicians to opt-out of their prescribing records being sold for marketing purposes.  Despite the timing, here’s copy in the Bangor Daily News and the Wall Street Journal.  And RxP director Rob Restuccia talks to iHealthbeat about the practice.

Next week, the U.S. Court of Appeals in Boston will hear New Hampshire’s appeal of an earlier district court ruling that struck down its prescription data-mining ban in April 2007.

DSM disclosure dismal, says U.S News and World Report

U.S News and World Report takes a closer look at the disclosure ordered up for members of the current DSM update panel – and found less-than-rosy results.  All but eight of the 27 panel members charged with writing the manual that defines what’s a mental health disease and what’s not have financial ties to the pharmaceutical industry, and the news journal found disclosure of those relationships vague and incomplete, despite the APA’s claim that they are a great marker of transparency. Thanks to Pharmalot for the tip.

Miscellany Rx

The Grey Lady finally digested the survey on medical professionalism released in the Annals of Internal Medicine in early December and has this to say about physician professionalism and its bearing on cost and quality.

And here’s the latest on activists taking on the FDA over Provenge, after the regulatory agency flip-flopped on approval of the prostate-cancer drug by Dendreon.  Advocate groups, some of which accept pharma money and others that do not, claim that some of the dissenting advisory board members had conflicts of interest, including a lead investigator on a competitor drug to Provenge.

Ta-da!

The Prescription Project Weekly Reader,  a weekly email of pharma/conflict-of-interest news in review, is moving to PostScript, where it will appear every Friday,  rain or shine.

If you have been receiving the Weekly Reader by email, we invite you to subscribe to PostScript in the right-hand column, and every friday, the Reader will arrive in your inbox, just like the old days.

And if you are just passing by, we hope you’ll subscribe, too, or stop back on Fridays to catch up.

No shortage of news, though, so let’s start in.

Putting off-label studies on the table

Yesterday we posted here about the FDA’s draft guidance on permitting drug marketers to use off-label studies, but coverage abounds in the Washington Post, WSJ Healthblog, and Kaiser Health Policy Daily Report, to name a few.

and speaking of detailing…

This AP report says that physicians are spending less time with drug reps and more time with online detailers.  According to the report, a research firm recently found that just one-quarter of sales visits actually involved an in-person encounter with the good doc.

“Patients are watching, medical students are watching and it’s just become harder and harder to justify these interactions,” online pharma marketing executive David Kramer told the AP.

Weighing the pros and conflicts

Doctors don’t always adhere to the high ethical standards they hold their profession to, according to a new study in the Annals of Internal Medicine this week.  Though 90 percent said that incompetent colleagues should be turned in, 45 percent said they hadn’t always done so, according to this AP report.

Moreover, a quarter of respondents said they’d refer a patient to an imaging center in which they had financial stake without revealing the conflict of interest.  Our favorite part: The AP reported that 21 doctors cashed the $20 survey incentive check without sending back the  survey.

Here’s coverage at the Boston Globe, Washington Post, Health Care Renewal and Pharmalot, too.

What sort of asssistance is Montel offering, anyway?

Montel Williams pitched critics of PhRMA’s marketing machine (and matching tour bus) a softball this week when he threatened a high school intern who asked whether pharmaceutical companies would conduct as much research if profits were restricted.  In the age of YouTube, this story is even juicier.  Read all about it at Prescription Access Litigation blog, Pharmalot, or WSJ Healthblog.

Osh Kosh, My Gosh

The Oshkosh Northwestern points a finger at Oshkosh orthopedist Dr. Jeffrey McLaughlin, who received $600,000 last year in payments from medical device makers, 45 percent of Wisconsin’s take and the most among state docs and healthplans.

The balance sheets are part of an anti-kickback settlement with the federal goverment earlier this year in which five medical device-makers were required to post payments to doctors and providers in online public databases.

The Kennebec Journal – Morning Sentinel looks again at the prescription data-mining issue. Hearings from a challenge to the law restricting the sale of doctors’ prescribing data through an ‘opt-out’ provision have begun, and the health information organizations that aggregate the data and pair it with pharmacy records are looking for an injunction to the law.

Old and off-label

In a follow-up to last week’s summary of an earlier St. Petersburg Times story, the Wall Street Journal looks at the growing use of atypical antipsyotics in nursing homes and connects it with the 1987 law President Reagan signed that restricted restraint tactics that could be used in eldercare facilities. Sen. Chuck Grassley (R-IA) has begun an investigation.

FDA isn’t tilting at windmills for this one

At least, that’s the word from a new report by the Center for Science in the Public Interest that said finding conflict-free experts isn’t as hard as the FDA said it was last month, when it released the results of its own report on the feasibility of assembling conflict-free expert panels.

In an open letter to FDA commish Andy von Eschenbach, CSPI joined with the National Physicians Alliance, Consumers Union and the Union of Concerned Scientists to call on the FDA to create conflict- free panels as opposed to the patchwork of COI waivers that currently compose the committees. Healthcare Renewal, The Scientist, and Pharmalot all weighed in.

Too different to disclose? drugs vs. devices in MN

In a follow-up to last week’s question about why Minnesota’s drugmaker gift disclosure laws don’t cover device makers, Howard Brody over at Hooked has a few ideas.

“I don’t need a drug rep on site to show me how the patient is supposed to swallow a capsule,” Brody writes.  “Virtually all the information that I need to know about how to prescribe a drug could be provided to me in writing. For many devices this is not true.”

A banner year for safety breaches, and a bad one for pharma

Hats off to Pharmalot for pointing out this “Top Ten Drug Warnings and Recalls of 2007″ from FiercePharma.

And it this makes you nostalgic, here’s a new WSJ report on an old refrain: Big Pharma’s prospects are drooping as economic, management and regulatory models shift. Bonus gloom and doom: you may need a subscription to read this one.