Doctors can prescribe a drug to treat an illness even if the FDA has not approved that use, but promotion of off-label activity is a big no-no. So in a letter sent today to Roger Meyer, who heads the firm (pictured right), Grassley wants to know more about Best Practice’s questionable practices. The Senator notes that the claims can be found on older versions of the firm’s web site (you can look here at an archived version). This is the Best Practice web site today.

How did Grassley find Best Practice? By investigating Goodwin, who we wrote about earlier. Last March, on an episode of his program, “The Infinite Mind,” which is heard on 300 NPR stations, featured three experts who discussed the controversial link between antidepressants and suicide. And all four, including Goodwin, declared that worries about the drugs have been overblown.

As it turns out, Goodwin also had undisclosed ties to drugmakers. Since 2000, for instance, Glaxo paid Goodwin more than $1.2 million in speaking fees and over $100,000 in expenses. And Glaxo markets the Paxil antidepressant, which UK regulators determined that the drugmaker had been aware since 1998 that its pill was associated with a higher risk of suicidal behavior in adolescents. NPR is embarassed and angry by all this and yanked the program from its satellite service (here is the back story, complete with a chart and a link to Grassley’s comments in the Congressional Record).

Behrman, who wrote “Electroboy: A Memoir of Mania,” a memoir of mania, bipolar disorder and his experiences undergoing ECT, calls his latest “Adventures in the Drug Trade: I Was a Big Pharma-Pusher.” He was taking Abilify but stopped two years ago after some difficulties and severed his relationship with the drugmaker. The manuscript is due to go to publishers in January, after Behrman’s nondisclosure agreement with the drugmaker expires, the gossips say.

Hat tip to Furious Seasons

The litigation, which was filed in 2005, claimed McKesson and First DataBank, which publishes pricing data, reached a secret deal on how the so-called average wholesasle price would be set for brand-name drugs, and in doing so, raised the spread between the published AWP and the actual acquisition costs from 20 to 25 percent in an effort to increase profits.

Last March, a federal judge in Boston certified the lawsuit as a class action and allowed it to be tried under the US Racketeer Influenced and Corrupt Organizations Act, or RICO (look here). A trial was set for December 1, but McKesson, which admitted no wrongdoing, made the deal to avoid the “uncertainty” of litigation. The wholesaler will also set aside about $143 million to settle claims from state health programs (see McKesson statement and here is the original lawsuit).

Just the same, McKesson still faces similar lawsuits by state and local governments. San Francisco sued the distributor last May, saying McKesson’s price manipulation cost consumers “hundreds of millions of dollars.” The state of Connecticut also filed such a suit.

The plaintiffs claimed the listed prices, which were used by payors to set reimbursement rates, were “arbitrarily” increased from 2001 to 2005 by McKesson and First DataBank, not through surveys of wholesalers. While McKesson itself didn’t directly gain from the alleged practice, the distributor increased its market share with retailers, costing $5 billion in inflated prices.

“The impact of this settlement is very significant for all who have paid for brand-name drugs,” Steve Berman, managing partner at Hagens Berman Sobol Shapiro and lead counsel for the plaintiffs, says in a statement.

A petition signed by over 200 faculty and students was delivered to the office of med school dean Jeff Flier, And the event drew the attention of representatives from Pfizer and former New England Journal of Medicine editor Arnold Relman, a med school professor who extemporaneously addressed the group.

Med school students, who spend their third and fourth years at affiliated hospitals for clinical education traiing, say they have been nudging the administration to revamp conflict of interest policies both in the classroom and at the affiliated hospitals for roughly six years to little or no avail. Some want a mandate that faculty and students disclose financial ties to pharma when discussing drugs developed by those companies in the classroom.

“We really view this issue as something that is key to the integrity of medical education at Harvard,” David Tian, a first-year student, tells the student paper. “Starting with our third year, our teachers are the doctors who are interacting with industry on a daily basis in ways that the medical school currently doesn’t standardize or set standards for.”

Here is the rest of the story…

Hat tip to PharmaGossip

In the past month, at least five biotechs filed for bankruptcy. Those at highest risk have experimental compounds moving into costly human research. The amount raised this year by biotechs fell by $9.7 billion through September, or 54 percent, compared with the same period in 2007, according to Burrill & Company, a life sciences investment bank. That may mean work on dozens of potential treatments will stall or die as workers are fired and early research projects are shelves, Bloomberg writes.

“I’m looking down the barrel of a gun,” says Tom Mathers, ceo at Peptimmune, a privately held, six-year-old biotech in Cambridge, Massachusetts, that is struggling to pay for clinical trials of a multiple sclerosis drug. He cut staff by more than half to 22 people, moved to smaller offices to conserve $6.5 million on hand and is delaying research on new drugs for Alzheimer’s disease and Parkinson’s.

US biotechs are raising less cash than they have in a decade, according to Burrill. Financing fell to $8.2 billion through September, from $17.9 billion last year. Venture capital funding fell 16 percent, to $2.9 billion, Bloomberg writes.

“For the first time in the history of the biotech industry, you’re going to see unprecedented levels of bankruptcies and dissolutions,” David Strupp, managing director in the life sciences group at Canaccord Adams, a research and investment bank, tells Bloomberg. “This all will play out in the next six to nine months.”

Biotech bankruptcies have been rare because struggling companies often dodged trouble through mergers, licensing or development deals, or through investors willing to make cash infusions, he adds. Now, though, a large number are “not cycling out of this queue,” Strupp explains to Bloomberg. “Wall Street won’t finance them, and the pharmaceutical industry can’t buy all of them. They keep marching forward without the ability to get saved.”

Peptimmune’s most advanced drug, PI-2301, is a multiple sclerosis treatment designed to be taken weekly. It would compete with Teva Pharmaceutical’s daily treatment Copaxone, which generated $1.7 billion in sales last year. Peptimmune is counting on positive data from a study due in 2009 to show its drug is better than Copaxone. “If the multiple sclerosis program doesn’t do well, it will be very difficult for this company to raise money,” Mathers tells Bloomberg.

And Bloomberg makes an interesting point: Four of six MS treatments approved by the FDA were developed by biotechs.

Peptimmune, with no products on the market, has raised and spent about $85 million. Biotechs without products on the market, or those unable to access equity markets by selling shares, are the ones in most need of cash to fund clinical studies. Yet biotech initial public offerings have almost disappeared, with just one, for $5.8 million, so far in 2008. That’s down from 28 IPOs that raised $1.7 billion last year and from 66 in 2000 that garnered $6.5 billion, Bloomberg writes.

The most likely to seek bankruptcy are those with less than six months of cash on hand, just a few drugs in development and no definitive clinical data to attract a funding partner, Andrew Busser, principal at Symphony Capital, tells Bloomberg. Twenty-five percent of the 370 public US biotechs have less than six months of cash, according to data compiled by the BIO trade group.

A Darwinian pruning of the weakest is inevitable, and isn’t necessarily to be mourned, according to Peter Wysong, a health care investment banker for Natixis Bleichroeder. “Most people would probably say there have been too many biotechnology companies that have been like the walking dead,” he tells Bloomberg. “The deaths will be concentrated among companies that have little to offer.”

Earlier this month, MicroIslet, a San Diego developer of diabetes treatments, and Accentia Biopharmaceuticals, of Tampa, Florida, sought bankruptcy protection to reorganize, each citing an inability to raise money.

MicroIslet spent $50 million during the past decade developing an experimental treatment for Type 1 diabetes that would involve transplanting insulin-producing cells harvested from the pancreas of pigs into diabetics to allow them to forego insulin injections. The treatment, tested in animals but not in humans, came from technology developed at Duke University in Durham, North Carolina.

With the company $3 million in debt and needing millions more to begin clinical studies, private investors turned away, leaving MicroIslet without money for human tests, according to ceo Michael Andrews. “We’re at a stage that a lot of companies are in, where it’s time to raise money but there’s no clinical data and you’re not a brand new company coming out of academia,” he tells Bloomberg. “I suspect there will be a number of companies that will go down this path.”

In October, AtheroGenics, which was developing a diabetes drug, filed for bankruptcy after defaulting on $302 million in debt the previous month. Orchestra Therapeutics also filed last month. The long-struggling company was co-founded in 1986 by the late Jonas Salk, the polio-vaccine developer who sought to find a way to immunize patients against AIDS, Bloomberg points out.

Recently, Amylin Pharmaceuticals announced plans to cut 16 percent of its workforce, or about 340 employees, to try to save $80 million in 2009. And Cell Genesys halted work on a prostate cancer med after deaths were reported in a study, and will fire 230 workers, or 80 percent of its workers, by year-end, Bloomberg reminds us.

The lucky ones find buyers among bigger drugmakers to keep research programs alive. That’s what happened to Genelabs Technologies, which develops of hepatitis C treatments and last month agreed to be bought by Glaxo for $57 million. Genelabs’ market value had plunged to $10 million and its stock had lost 82 percent of its value this year before the deal was announced, Bloomberg notes.

“The sign over Wall Street for small biotechs is ‘closed for the season,’” Genelabs ceo Fred Driscoll tells Bloomberg.

Other biotech that are unable or unwilling to find a partner will go into “hibernation, just doing enough to keep the technology alive and waiting for a better day,” Glen Giovannetti, who heads Ernst & Young’s Biotechnology Center, tells Bloomberg.

Investors will likely return to biotech once the economy stabilizes because the industry still promises attractive returns, according to Brent Milner, managing director of health care investing at Stanford Financial Group, an investment bank. “Stock-picking will come back in vogue and people will ask, ‘Where are the 30 percent growers?” Milner tells Bloomberg. “When that happens, everyone will again look to biotech because everyone loves a lottery ticket. I think there is a long-term silver lining.”

Source: Bloomberg News

But there was a catch: Goodwin never pointed out that all three guests had ties to pharma, or that the show received “unrestricted” from drugmakers, including Lilly, which sells Prozac and Cymbalta. The segment, by the way, aired just two months after UK regulators concluded a four-year investigation of Glaxo’s Paxil and found the drugmaker had been aware since 1998 that its pill was associated with a higher risk of suicidal behavior in adolescents (back story).

Now, Chuck Grassley, the ranking Republican on the US Senate Finance Committee, reveals Goodwin, a former director of the National Institute of Mental Health, also has substantial ties to pharma, including…drumroll…Glaxo. According to Glaxo documents given to Grassley’s sleuths, since 2000, Glaxo paid Goodwin more than $1.2 million in speaking fees and over $100,000 in expenses (see chart below).

And so Grassley, who is sharply critical of NPR for failing to enforce its own conflict policies, is asking the National Institutes of Health and the National Science Foundation, both of which have underwritten his program, about their disclosure policies. UPDATE: The New York Times is on the story and writes that Bill Lichtenstein, the program’s producer, was unaware of Goodwin’s financial ties and says earlier this year, Goodwin denied receiving any funding. Margaret Low Smith, NPR’s vp, says the show will be removed from the satellite service next week and innsists it would not have aired if NPR had known of Goodwin’s ties (look here).

This is what Grassley entered into the Congressional Record on Wednesday:

“GlaxoSmithKline pays him around $2,500 for every talk his gives on treatments for bipolar disorder and depression. These talks concerned several drugs such as Wellbutrin, Eskalith, and Lamictal. Based on documents that my office received from GlaxoSmithKline, Dr. Goodwin gives these talks to doctor groups around the country. So far this year, Glaxo reports that the company paid Dr. Goodwin over
$130,000 for over 50 different talks…

“In the fine print of an article he published in the Journal of the American Medical Association in 2003, Dr. Goodwin acknowledged that he ‘has served on the speaker’s bureaus of Glaxo, Solvay, Janssen, Pfizer, Lilly, AstraZeneca, and Bristol-Myers Squibb; and has served as a consultant for Glaxo, Solvay, Pfizer, Lilly, Bristol-Myers Squibb Elan, and Novartis.’ For example, over the last seven years, he received over $1.3 million in speaking fees and honoraria from GlaxoSmithKline for giving over 480 talks.

“Dr. Goodwin was very busy the week that the episode of ‘Prozac Nation: Revisited started airing last March 26. GlaxoSmithKline’s records show that the company paid Dr. Goodwin for several talks he gave that week on bipolar disorder and Lamictal. In fact, records show that he gave around eight talks at $2500 each, bringing him around $20,000 in payments. Several of the talks were done by teleconference, but Dr. Goodwin also spoke about Lamictal at Fleming’s Prime Steakhouse in Birmingham, Michigan, and the Rosebud Steak House in Schaumburg, Illinois…

“Based upon the information provided to my staff, Dr. Goodwin was also very active on behalf of Glaxo in 2005. That year, Glaxo paid Dr. Goodwin over $300,000 in speaking fees and around $25,000 in expenses to discuss their products. And this was the same year that he hosted an episode for “The Infinite Mind” on bipolar disorder in kids. Again, there was no disclosure on the show about Dr. Goodwin’s financial ties to GlaxoSmithKline or other drug companies (click on the chart to enlarge)…

“When an episode on bipolar disorder first aired on September 20, 2005, Dr. Goodwin was once again on the road for the Glaxo. Glaxo’s records show that the company paid him, $2,500 for a talk he gave that day on drug therapy for bipolar disorder. The talk was at Lemonia, a Tuscan restaurant located at the Ritz-Carlton Golf Resort in Naples, Florida…

“I don’t think it takes a journalism or ethics professor to figure out that listeners of a national radio show should be told about the host’s financial interests. It just seems obvious. This type of information should be out in the open and transparent. People should know that since 2000, GlaxoSmithKline has paid the host of a radio program on psychiatry over $1.2 million in speaking fees and over $100,000 in expenses…

“People should know that, based on information from Glaxo, most of these fees were paid to Dr. Goodwin through Best Practice, a pharmaceutical consulting firm that he helped establish in the late ’90’s. Among the many services that have been offered by Best Practice are marketing consultation, and the ‘dissemination of new off-label information….’

Grassley also skewered NPR, noting that “The Infinite Mind, run on NPR’s satellite station: “According to NPR’s own policies, and I quote, ‘confidence in us as independent and fair means avoiding actual and apparent conflicts of interest or engaging in outside activities, public comment or writing that calls into question our ability to report fairly on a subject.’ The policy also states that an individual covered under this code ‘has the responsibility to disclose potential conflicts of interest.’ ”

Check out the Congressional Record (type in ‘Goodwin’ in the box)

So, at 8:30 am EST today, the FTC will conduct a workshop organized into five panels to discuss the following issues: the price and market share effect of entry by both biosimilar and biogeneric drugs, the likely competitive effects of reference product regulatory exclusivity, biotechnology patent issues, the likely competitive effects of follow-on biologic regulatory incentives, and the patent resolution process.

The FTC, you may recall, wrote a letter in May to the House Energy & Commerce Committee, saying Congress “should limit companies’ ability to game…exclusivities at the expense of consumers by (1) disconnecting the FDA approval process for generic biologics from patent litigation, and (2) ensuring there is no opportunity for brands effectively to lengthen their exclusivities through insignificant changes to a branded biologic product or through excessive procedural delays.”

Panelists will include luminaries from the FDA, BIO, insurers, generic and brand-name drugmakers, academia and patent lawyers. This is the agenda, and these are the public comments filed with the FDA by various companies and groups over the past several weeks. The roundtable, by the way, will be webcast (go here to tune in).

And here is something we hope to make a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that PDI, a contract sales organization, hired Nancy Lurker, 50, as ceo and also appointed her to its board. Previously, Lurker was senior vp and chief marketing officer at Novartis, and before that, ceo at ImpactRx, a market research firm, and traveled through Pharmacia and Bristol-Myers Squibb.

Elan hired Lilly exec Carlos Paya as president;
etrials Worldwide named Denis Connaghan as ceo and president;
Varian Medical named Venkatraman Thyagarajan to its board;
Ascent Therapeutics appointed Fred Jones as ceo and president;
Advanced Proteome says Robert Bender and Russ Phares resigned from its board;
Wyeth named Mike Kamarck as president of technical ops and product supply;
Compugen appointed Martin Gerstel as ceo;
ZymoGenetics promoted Doug Williams to ceo;
Middlebrook Pharma hired Frank Koos as senior vp, sales & biz development;
WorldCare Clinical hired John Tomera as director of regulatory affairs;
Ferring Pharma promoted Bill Garbarini Jr. to vp of orthopaedics and urology biz;
Clinilabs named Howard Greenberg as senior medical director of clinical pharmacology;

Glaxo Signs China JV Deal For Flu Vaccine (Dow Jones)

No Heart Risk With Takeda Gout Drug: FDA (Reuters)

Pfizer Still Interested In Obesity Drugs (Reuters)

FDA Clears Glaxo Promacta Blood Clot Drug (Yahoo/AP)

FDA Panel Backs New Use For J&J Catheter (Yahoo/AP)

CombinatoRx Cuts More Jobs (The Boston Globe)

Earlier this week, the FDA advisory committee slammed the rising use of antipsychotics in youngsters, particularly to treat attention deficit disorders. The meds, you see, were approved by the agency for schiozphrenia or bipolar disorder - and only recently for youngsters, in some cases (back story).

The trend, however, to prescribe these meds for teenagers and children has actually been widespread, with Medicaid programs in several states reporting rising expenditures for antipsychotics to treat ADD or ADHD. A report issued last year by the University of South Florida found that among children 5 years or younger, 53.8 percent were prescribed antipsychotics for a diagnosis of ADHD. The figure was 48.8 percent for children between 6 and 12 years old (see page 22).

The issue is gaining attention because most of the meds can cause weight gain and metabolic disorders, and the FDA committee complained current warnings are insufficient. The meds include Johnson & Johnson’s Risperdal, Lilly’s Zyprexa, AstraZeneca’s Seroquel, Bristol-Myers Squibb’s Abilify and Pfizer’s Geodon. As we have written previously, a consortium of state Medicaid directors is evaluating the use of the drugs in children to ensure they are being properly prescribed (take a look).

And now we have another example. In Maine, spending by the state Medicaid program on each of the five widely prescribed antipsychotics has been rising for children 18 years and younger since 2000, except for Zyprexa. At the same time, ADHD has been the number one diagnosis among the same population each year, except for last year, when prolonged post-traumatic stress disorder was more widely diagnosed. See the chart. The data is courtesy of the Office of Maine Care Services.