The practice even makes McDonald's, one of the nation's biggest beef purchasers, nervous. "We do not condone the feeding of poultry litter to cattle," it said in a statement.
via latimes.com
Saturday, October 31, 2009
Study cites concerns over Amgen drugs » Ventura County Star
A new study raises fresh safety concerns about widely used anemia medicines, finding that the drug Aranesp nearly doubled the risk of stroke in people with diabetes and chronic kidney problems who are not yet sick enough to need dialysis.
The study is the largest ever of these blood-boosting drugs and the only one that compared them to a dummy treatment. The medicines have become blockbuster sellers because they lessen the need for transfusions, but their ability to prevent heart attacks, kidney failure or other problems have not been proven.
Over the past two years, the federal Food and Drug Administration has repeatedly strengthened warning labels on Aranesp, Epogen and Procrit as concerns rose that they may worsen survival in certain cancer patients, especially at higher doses. Amgen Inc. of Thousand Oaks makes all three drugs, although New Brunswick, N.J.-based Johnson & Johnson sells Procrit.
The new study tested Aranesp in a different group of patients: 4,038 people with Type 2 diabetes, kidney problems and moderate anemia — problems that often go hand in hand. The goal was to see if the drug could prevent heart attacks, heart failure, strokes or the need for dialysis.
It not only failed to do that, but “we uncovered a risk that I think is substantial for stroke,” said study leader Dr. Marc Pfeffer, a heart specialist at Brigham and Women’s Hospital in Boston.
Strokes occurred in 101 patients given Aranesp and 53 patients given dummy shots. Looked at another way, the risk of suffering a stroke was about 1 percent per year in the placebo group and about 2 percent in those given Aranesp.
For many people, “this risk will outweigh its potential benefits,” the study’s authors conclude.
Results were published online Friday by the New England Journal of Medicine and were to be presented at a conference of kidney specialists in San Diego. Amgen sponsored the study. Pfeffer has consulted for the company and two authors work for it.
Dr. Roger Perlmutter, Amgen’s head of research and development, said the magnitude of stroke risk “surprised us.” The potential risk of stroke has been listed on Aranesp’s label since the drug was approved in 2001, but “we will definitely update the label” because of the new study’s results, he said.
Aranesp did reduce the need for transfusions — 297 people on the drug needed them versus 496 of those getting dummy shots. However, there was only a modest improvement in how fatigued people said they felt in the Aranesp group.
The study’s results may not apply to people already on dialysis, Dr. Philip Marsden of St. Michael’s Hospital and the University of Toronto in Ontario, Canada, writes in an editorial in the medical journal. For them, the quality of life improvement from fewer transfusions may be greater.
Also on Friday, the New York Attorney General’s Office said it and 15 states were suing Amgen, claiming the company gave kickbacks and weekend retreats to medical providers to help boost Aranesp sales, and encouraged them to bill third parties, including Medicaid, even though the drug was available to them at no cost.
A statement by the company said the allegations were “without merit.”
via vcstar.com
A drug rep speaks
"So, Dr. Grumpy, you know, I came in because I'd like to know, you know, what you, like, know about our new product, and what your patient's know about it, and, like, what you think about it, and all that stuff, like that, you know?"
Source
Source
Friday, October 30, 2009
Amgen - Aranesp: allegedly rewarding medical providers with kickbacks
The New York Attorney General’s office announced Friday that New York and 14 other states will sue biotech giant Amgen for allegedly rewarding medical providers with kickbacks if they helped to boost sales of anemia drug Aranesp.
“Drugs should be prescribed to patients on the basis of need, effectiveness, and safety, not on a corporate giant’s promise of an all-expense paid vacation,” said Attorney General Cuomo in a statement.
The lawsuit alleges that starting in 2002, Amgen bribed medical providers with free Aranesp to motivate them to prescribe and purchase the drug. The suit claims the company then encouraged medical providers to submit false claims to Medicaid and other third parties for payment, when the drug was already available free to those same providers.
In 2003, the company conspired with the International Nephrology Network and its parent, ASD Healthcare, to lure customers from competing anemia drug Procrit, to Aranesp in an effort to boost sales, according to the lawsuit.
In addition to New York, other states participating in the suit include: California, Delaware, Florida, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Nevada, New Hampshire, New York, Tennessee, and Virginia, and the District of Columbia.
More
“Drugs should be prescribed to patients on the basis of need, effectiveness, and safety, not on a corporate giant’s promise of an all-expense paid vacation,” said Attorney General Cuomo in a statement.
The lawsuit alleges that starting in 2002, Amgen bribed medical providers with free Aranesp to motivate them to prescribe and purchase the drug. The suit claims the company then encouraged medical providers to submit false claims to Medicaid and other third parties for payment, when the drug was already available free to those same providers.
In 2003, the company conspired with the International Nephrology Network and its parent, ASD Healthcare, to lure customers from competing anemia drug Procrit, to Aranesp in an effort to boost sales, according to the lawsuit.
In addition to New York, other states participating in the suit include: California, Delaware, Florida, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Nevada, New Hampshire, New York, Tennessee, and Virginia, and the District of Columbia.
More
The speaker went looking -- and found Big Pharma.
As Speaker Nancy Pelosi sat down to put the finishing touches on the House health care bill Wednesday night, the California Democrat was stuck between four competing directives.
The first three, handed down by President Obama, required that the bill must not cost more than $900 billion over ten years, must not add "one dime" to the deficit and must not require the pharmaceutical industry to pony up more than $80 billion, in accordance with a deal struck between the White House, the Senate Finance Committee and the Pharmaceutical Research and Manufacturers of America (PhRMA).
The fourth, foisted on her by her conservative Democratic members, required the public health insurance option to negotiate rates with health care providers. She had been unable to find 218 votes for a more "robust" version of the public plan -- with reimbursements tied to Medicare rates -- which would have saved taxpayers $85 billion over ten years.
That meant Pelosi had to find $85 billion somewhere. The speaker went looking -- and found Big Pharma.
Read more at: Huff Po
Shire subpoenaed over ADHD drug marketing
U.K. drug maker Shire said Friday it has been subpoenaed by the U.S. authorities over the marketing of three drugs, as it reported a swing into profit for the third quarter.
Shire said, as part of its third-quarter results, that it received a subpoena Sept. 23 from the U.S. Department of Health and Human Services and the U.S. Attorney for the Eastern District of Pennsylvania, asking it for documents related to the sales and marketing of Adderall XR, Daytrana and Vyvanse, three drugs for attention deficit hyperactivity disorder, or ADHD.
Shire said, as part of its third-quarter results, that it received a subpoena Sept. 23 from the U.S. Department of Health and Human Services and the U.S. Attorney for the Eastern District of Pennsylvania, asking it for documents related to the sales and marketing of Adderall XR, Daytrana and Vyvanse, three drugs for attention deficit hyperactivity disorder, or ADHD.
AstraZeneca - Brilinta: not quite so brilliant
Back story.
AstraZeneca is looking into whether greater use of aspirin reduces the effectiveness of its experimental clot-busting medicine Brilinta, which analysts had estimated would bring in $1 billion a year.
AstraZeneca’s Brilinta beat Sanofi-Aventis SA and Bristol- Myers Squibb Co.’s blood thinner Plavix in a study, preventing 16 percent more heart attacks, strokes and deaths. The trial included more than 18,000 patients in 43 countries. Those in North America may have done worse on Brilinta, a finding that raised questions among analysts about potential U.S. sales. London-based AstraZeneca said today that researchers noticed a link between higher doses of aspirin and Brilinta’s potency.
Brilinta is one of four medicines AstraZeneca planned to seek approval for this year to offset declining sales of products that will lose patent protection. The U.K. drugmaker withdrew its application for lung cancer therapy Zactima yesterday after an analysis showed the drug didn’t improve patients’ survival. Third-quarter profit rose 23 percent.
“Of the four drugs due for filing this year: Zactima has been pulled; Brilinta looks very weak to us now, and that leaves two,” said Navid Malik, an analyst at Matrix Corporate Capital in London, in a note to clients. “With 40 percent of revenues going generic in the next five years, we would be highly concerned about AstraZeneca’s future earnings and sales potential.”
AstraZeneca’s Brilinta beat Sanofi-Aventis SA and Bristol- Myers Squibb Co.’s blood thinner Plavix in a study, preventing 16 percent more heart attacks, strokes and deaths. The trial included more than 18,000 patients in 43 countries. Those in North America may have done worse on Brilinta, a finding that raised questions among analysts about potential U.S. sales. London-based AstraZeneca said today that researchers noticed a link between higher doses of aspirin and Brilinta’s potency.
Brilinta is one of four medicines AstraZeneca planned to seek approval for this year to offset declining sales of products that will lose patent protection. The U.K. drugmaker withdrew its application for lung cancer therapy Zactima yesterday after an analysis showed the drug didn’t improve patients’ survival. Third-quarter profit rose 23 percent.
“Of the four drugs due for filing this year: Zactima has been pulled; Brilinta looks very weak to us now, and that leaves two,” said Navid Malik, an analyst at Matrix Corporate Capital in London, in a note to clients. “With 40 percent of revenues going generic in the next five years, we would be highly concerned about AstraZeneca’s future earnings and sales potential.”
AstraZeneca to Pay $520 Million to Settle Four Seroquel Cases - NYT
The pharmaceutical company AstraZeneca said Thursday that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel.
One of the investigations related to “selected physicians who participated in clinical trials involving Seroquel,” AstraZeneca disclosed in a government filing. The other case related to off-label promotion of the drug.
As a result of aggressive marketing, Seroquel has been increasingly used for children and elderly people for indications not approved by the Food and Drug Administration. Doctors are permitted to prescribe any approved drug for off-label uses.
Seroquel was the top-selling antipsychotic drug in America. It had $17 billion in sales in the United States since 2004, according to IMS Health, a research firm.
Tony Jewell, a company spokesman, declined to be more specific about the physicians or clinical trials under investigation. He said the company was in final negotiations to settle the whistle-blower suits and reach a corporate integrity agreement with the Justice Department.
The name of the whistle-blowers and other details of the suits remained sealed in federal court. Stephen A. Sheller, a lawyer in Philadelphia for the whistle-blowers, and Patricia Hartman, a spokeswoman for the United States attorney in Philadelphia, both declined to comment.
AstraZeneca, based in Britain, joins a list of drug makers that have paid billions to settle inquiries initiated by complaints from former company insiders.
Earlier this year, Eli Lilly & Company paid $1.4 billion over its marketing of Zyprexa, another antipsychotic drug. And Pfizer announced it would pay $2.3 billion, including a record $1.195 billion criminal fine, mostly over its painkiller Bextra, which has been withdrawn from the market.
AstraZeneca disclosed the settlement in a financial report. Third-quarter revenue rose 10 percent, to $8.2 billion, and operating profit rose 29 percent, to $3.6 billion, at constant exchange rates over the year-earlier quarter.
AstraZeneca also said it had been served with 14,444 civil lawsuits over the drug as of Oct. 9. Ed Blizzard, a lawyer for some of the people suing AstraZeneca, said Thursday that many patients have developed diabetes and other health problems because of misleading marketing.
Mr. Blizzard said he did not know what clinical trials were part of the inquiry. But in one trial, known as Study 15, he noted, an e-mail message showed a company official saying “a great ‘smoke and mirrors’ job’ ” had been done on a “buried” study in 1997, the year the F.D.A. approved Seroquel.
via nytimes.com
United States Attorney's Office - Eastern District of Pennsylvania
Eli Lilly Plea and Settlement
Eli Lilly and Company (Eli Lilly) and the government (the Office of the United States Attorney for the Eastern District of Pennsylvania and the Office of Consumer Litigation of the Department of Justice) entered into an agreement whereby Eli Lilly agrees to plead guilty to the introduction into interstate commerce of quantities of its drug, Zyprexa, that were misbranded in violation of 21 U.S.C. §§ 331(a), 333(a)(1) and 352(f)(1). Specifically, Eli Lilly will plead guilty to promoting Zyprexa in elderly populations as treatment for dementia, including Alzheimer's dementia, between September 1999 and March 31, 2001.
The entry of plea and sentencing hearing in this matter will be held before the Honorable Robert F. Kelly on Friday, January 30, 2009, at 10:00 a.m. in Courtroom 11B, 11th floor of the United States District Court, United States Courthouse, 601 Market Street, Philadelphia, Pennsylvania. The case has been assigned the criminal docket number 09-020.
All government filings, both criminal and civil, are available for your convenience on the following links:
- Information
- Guilty Plea Agreement
- Government's Memorandum For Entry Of Plea and Sentencing
- Corporate Integrity Agreement
- Settlement Agreement
- Government's Supplemental Motion in Anticipation of Sentencing and Judgment and Order of Forfeiture
To see the statement issued by Acting United States Attorney Laurie Magid, click here.
To see a press release issued by the United States Attorney’s Office for the Eastern District of Pennsylvania, click here.
To see a press release issued by the United States Attorney’s Office for the Eastern District of Pennsylvania, click here.
Benjamin Franklin Photo by B. Krist for the Greater Philadelphia Tourism Marketing Corporation
via justice.gov
Thursday, October 29, 2009
Janssen - Risperdal: "probably" busted!
A sales representative for Johnson & Johnson’s Janssen Pharmaceutica unit testified that he encouraged doctors to prescribe the antipsychotic drug Risperdal for unapproved uses.
Matthew D. Thompson, testifying today in a trial over claims by a former co-worker, said that in 2002 he pushed doctors to consider prescribing Risperdal in combination with other drugs, so-called augmentation therapy, even though government regulators hadn’t approved this use. Janssen’s training didn’t include any specific prohibitions against promoting the drug that way, he said.
“I’m not saying the company tried to hide it, but we didn’t think about augmentation in the realm of on-label or off- label at that time,” Thompson said. He said he was “probably” aware that promotion of such sales was illegal.
Thompson was the third witness called in the case of Lynn Powell, 36, who claims she was fired in February 2004 for complaining within the company about pressure to promote Risperdal for children and bipolar disorder patients when it was approved only for adults with schizophrenia. Thompson was Powell’s supervisor when she was fired.
More
Matthew D. Thompson, testifying today in a trial over claims by a former co-worker, said that in 2002 he pushed doctors to consider prescribing Risperdal in combination with other drugs, so-called augmentation therapy, even though government regulators hadn’t approved this use. Janssen’s training didn’t include any specific prohibitions against promoting the drug that way, he said.
“I’m not saying the company tried to hide it, but we didn’t think about augmentation in the realm of on-label or off- label at that time,” Thompson said. He said he was “probably” aware that promotion of such sales was illegal.
Thompson was the third witness called in the case of Lynn Powell, 36, who claims she was fired in February 2004 for complaining within the company about pressure to promote Risperdal for children and bipolar disorder patients when it was approved only for adults with schizophrenia. Thompson was Powell’s supervisor when she was fired.
More
AstraZeneca starts to come clean about Seroquel
Back history here.
AstraZeneca said it has reached an agreement in principle with U.S. attorney's office in Philadelphia to resolve an investigation related to its schizophrenia drug Seroquel sales and marketing practices.
The settlement accounts for $520 million of the $538 million provisions taken in the first nine months of the year, it said.
AstraZeneca said it has reached an agreement in principle with U.S. attorney's office in Philadelphia to resolve an investigation related to its schizophrenia drug Seroquel sales and marketing practices.
The investigation has also scrutinized "selected physicians who participated in clinical trials involving Seroquel," the company said, adding that the investigations are the subject of two sealed whistleblower lawsuits filed under the False Claims Act.
The settlement accounts for $520 million of the $538 million provisions taken in the first nine months of the year, it said.
UK medicines "the second cheapest in Europe"
Threats of prosecution and changes to the rules that govern who can act as a wholesaler were both touted as ways to end medicines shortages at an All-Party Pharmacy Group meeting held this week at Westminster (27 October 2009).
Currently, at least 200 medicines are affected by supply shortages, said Richard Baker, director general of the Association of the British Pharmaceutical Industry. This is despite manufacturers supplying more product than needed to meet UK demand for several medicines, he said.
Dr Baker said that the ABPI estimates that 10 per cent of pharmacists are exporting, with medium-sized multiples being largely involved. He hypothesised that short-line wholesalers are also involved.
One pharmacist, Alistair King, from Co-op pharmacy in Lincoln, stated that although his group of pharmacies does not export, he is approached two to three times a week by people asking him to supply stock for export. Equally, Howard Stoate MP (Lab, Dartford), and chairman of the APPG, said that in his role as a GP he is informed by pharmacists two to three times per week that they cannot access a medicine that he has prescribed.
From the 200 medicines currently affected by supply problems, £30m is being made through exports from the UK, Dr Baker said. Currently, some medicines in the UK are the second cheapest in Europe (behind Poland), he added.
More at PJ
Currently, at least 200 medicines are affected by supply shortages, said Richard Baker, director general of the Association of the British Pharmaceutical Industry. This is despite manufacturers supplying more product than needed to meet UK demand for several medicines, he said.
Dr Baker said that the ABPI estimates that 10 per cent of pharmacists are exporting, with medium-sized multiples being largely involved. He hypothesised that short-line wholesalers are also involved.
One pharmacist, Alistair King, from Co-op pharmacy in Lincoln, stated that although his group of pharmacies does not export, he is approached two to three times a week by people asking him to supply stock for export. Equally, Howard Stoate MP (Lab, Dartford), and chairman of the APPG, said that in his role as a GP he is informed by pharmacists two to three times per week that they cannot access a medicine that he has prescribed.
From the 200 medicines currently affected by supply problems, £30m is being made through exports from the UK, Dr Baker said. Currently, some medicines in the UK are the second cheapest in Europe (behind Poland), he added.
More at PJ
Quote
It is the most extraordinary thing, but I never read a patent medicine advertisement without being impelled to the conclusion that I am suffering from the particular disease therein dealt with in its most virulent form.
Jerome K. Jerome, Three Men in a Boat
FDA hearing to highlight secret clinical trial data — Sunlight Foundation's Real Time Investigations - Tracking Private Influences on Public Policy
Next week the Food and Drug Administration’s (FDA) transparency taskforce will be holding a hearing asking for people to comment on the issue at the core of the multi-media investigation we released today, “Heart of the Matter: How Congress and Special Interests Kept Clinical Trial Data Secret”:
The topics to be covered are: (1) early communication about emerging safety issues concerning FDA-regulated products, (2) disclosure of information about product applications that are abandoned (which means that no work is being done or will be undertaken to have the application approved) or withdrawn by the applicant before approval, and (emph. added) (3) communication of agency decisions about pending product applications.
We’ve also gotten a sneak preview of comments that Consumers Union will be filing. Here’s a key excerpt:
We urge the FDA to require the public posting of all trial results of applications that are abandoned or not completed within the estimated time period provided in the original clinical trial registration (Public Health Service Act section 402(j)(2)(A)(ii)(I)(jj)).
Section 402(j)(3)(D)(II) of the Public Health Service Act, as added by FDAAA (PL 110-85), should clearly require that unapproved drug and device trial information be made public. The FDA should move beyond the issue of unapproved applications to ensure that abandoned research data is also reported.
The arguments are overwhelming for advancing science through the public sharing of all clinical trial research results—regardless of whether that trial resulted in an application for FDA approval or amendment or whether the application was unsuccessful.
We will be following up to see who testifies at the hearing and what positions they take.
Japanese housewives answer to no central banker, to no finance minister, to no central authority whatsoever, and they have US$14 trillion in assets!
Lawrence Wilkerson, former chief of staff to United States Secretary of State Colin Powell, explains to an audience that Japanese housewives have funded America’s debt for over 30 years.
Go Al go!
In this clip from hearings this week he nails a witness from the right wing Hudson Institute pimping for the health care industry. Her claim? That health care reform would lead to more bankruptcies. He makes his point and thanks the witness, but she tries to score with a question of her own. Bad move.
Stryker indicted
Stryker Corporation learned today that a federal grand jury in the District of Massachusetts has returned an indictment charging Stryker Biotech LLC and certain current and former employees of Stryker Biotech with wire fraud, conspiracy to defraud the U.S. Food and Drug Administration (FDA), distribution of a misbranded device and false statements to the FDA. The Company disclosed in March of this year that its Biotech division was the target of a federal grand jury investigation being conducted by the U.S. Attorney's Office for the District of Massachusetts.
Specifically, the indictment accused Stryker Biotech LLC of promoting the use of two devices made for spinal and long bone surgeries for applications that had not been approved by the US Food and Drug Administration.
The Stryker products, called the OP-1 Implant and OP-1 Putty, have only been approved for rare cases. But prosecutors said the company encouraged doctors to use the devices, which were designed to stimulate bone growth, more broadly in combination with a bone void filler, called Calstrux, which has never been formally tested in humans or approved by federal regulators. Prosecutors said some patients who received the combination suffered serious medical problems.
Specifically, the indictment accused Stryker Biotech LLC of promoting the use of two devices made for spinal and long bone surgeries for applications that had not been approved by the US Food and Drug Administration.
The Stryker products, called the OP-1 Implant and OP-1 Putty, have only been approved for rare cases. But prosecutors said the company encouraged doctors to use the devices, which were designed to stimulate bone growth, more broadly in combination with a bone void filler, called Calstrux, which has never been formally tested in humans or approved by federal regulators. Prosecutors said some patients who received the combination suffered serious medical problems.
Wednesday, October 28, 2009
AstraZeneca withdraws Zactima from EMEA and FDA in lung cancer - Pharma Strategy Blog
« Using video in social media to bring science and biotechnology alive | Main
October 28, 2009
AstraZeneca withdraws Zactima from EMEA and FDA in lung cancer
Earlier this year I posted about the interim results in non-small cell lung cancer (NSCLC) for AstraZeneca's Zactima (vandetanib) at the ASCO meeting, as part of a review about VEGF inhibitors. Of the 3 trials available for review, one showed some responses and the other two 'had not yet reached significance'.
Unfortunately, it now seems that the final survival data was indifferent at best and AstraZeneca announced the sudden withdrawal of the marketing applications to the regulatory authorities this morning:
"The decision to withdraw these submissions was based on an updated analysis that demonstrated no overall survival advantage when vandetanib was added to chemotherapy as well as preliminary feedback from regulatory agencies that the current package with progression-free survival (PFS) as the primary endpoint may not be sufficient for approval."
Granted that oncology is a difficult area to develop new drugs, but the woes in this category have made for a sad and sorry 2009 for R&D this year so far.
With 2 months to go, perhaps we might see a stunning winner yet...
Related articles by Zemanta
- Oncology R&D can be a wild ride (pharmastrategyblog.com)
- Gene Mutation Improves Response to Lung Cancer Drug (nlm.nih.gov)
- What's hot at the ESMO conference this week? (pharmastrategyblog.com)
- AstraZeneca Pulls Cancer Drug Applications (online.wsj.com)
Posted by MaverickNY on October 28, 2009 in Drugs, Lung Cancer, Market Intelligence, Marketing, News, Oncology, Pipeline, Targeted Therapies | Permalink
Technorati Tags: AstraZeneca, NSCLC, vandetanib, VEGF, Zactima
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Genentech - Avastin: United States Senate Special Committee on Aging
KOHL PRAISES CMS DECISION TO REVERSE CODING REGULATION FOR EYE DRUG
October 28, 2009
WASHINGTON – Today U.S. Senate Special Committee on Aging Chairman Herb Kohl (D-WI) praised the Centers for Medicare and Medicaid (CMS) for announcing its intention to reverse a recent reimbursement coding decision involving Avastin, a popular drug used to effectively treat wet macular degeneration, a leading cause of blindness among seniors and the elderly. Avastin, a cancer-treating drug, is frequently used off-label in small amounts by eye specialists to treat eye disease. Both CMS and the medical community estimate that between 50 and 60 percent of physicians currently use Avastin instead of Lucentis, an alternative treatment. Both drugs are manufactured by Genentech however, Lucentis cost $2,000 a dose roughly 20 times as much as Avastin. Kohl wrote to CMS earlier this month to express his concern over the coding change.
“I’m pleased that CMS heeded the concerns of the medical eye care community and the Aging Committee. Even seniors who have insurance often cannot afford the high co-payments associated with Lucentis,” said Kohl. “Patients should have a choice between these drugs, both of which have been proven effective.”
Medicare spends approximately one billion dollars a year on reimbursements for Lucentis. The recent CMS coding change made it more difficult for ophthalmologists and retinal surgeons to be adequately reimbursed for their Avastin usage. Agency officials intend to return to the original reimbursement coding for off-label use of Avastin, ensuring its continuing availability for those physicians who wish to use it. CMS has said it will implement the reversal of the coding decision on January 1, 2010.
Kohl has been concerned with the issue of Avastin’s availability since 2007, when he sent letters to then-CMS Acting Administrator Kerry Weems, then-Food and Drug Administration Commissioner Andrew von Eschenbach, and Genentech, Inc.’s President of Product Development Susan Desmond-Hellman concerning Genentech’s proposed plan to limit the availability of its cancer drug Avastin to certain pharmaceutical compounding firms and pharmacies. At the time, some physicians charged that Genentech’s intention in limiting Avastin’s availability is to boost sales of Lucentis, their far more expensive drug. An October 12, 2007 Wall Street Journal article, entitled “Genentech to Limit Avastin Availability, Use of Cancer Treatment For Eye Ailment Hurts Sales of Targeted Drug,” stated that because Medicare is a large purchaser of Avastin, the cost to taxpayers could be as high as $1 to $3 billion dollars a year if availability of the drug is curbed.
# # #
via aging.senate.gov
Good!
Posted via web from Jack's posterous
Hat tip: The Healthcare Channel on http://thehcc.tv/
More Giles......
Phoni to draw on supertanker construction expertise
Phoni Pharmaceuticals, the imaginary Anglo-American pharmaceutical group, is paying oil tanker assembly experts to help improve manufacturing processes in its factories, in an unusual job-lending programme triggered by the downturn.
Since the summer, the company has agreed to fund at least two “lean experts” borrowed from Australian Supertankers Ltd., who are applying their knowledge of supertanker design and production techniques to drugs.
The agreement provides a way for the shpbuilding company to save short-term costs while not losing valuable employees at a time when the economic slowdown has triggered a slump in sales and output.
It also marks a fresh effort as the drugs industry comes under pressure to become more nimble and to improve efficiency after years in which manufacturing flexibility and efficiency were neglected because they represented such a small part of total medicine costs.
Marc Mywordes, Phoni vice-president of global operations, said: “Pharmaceutical supply chains have been way too slow to respond to change. Maneuverability has never been key. There’s a lot we can learn from the process design culture that comes from Australian Supertankers Ltd, which will help us improve our ability to change direction whilst also guaranteeing secure delivery of our products.”
“We think Australian supertankers are a superb business model, not just for us, but for all pharmaceutical companies, as the video below shows…
YouTube - The Front Fell Off-Interview
Tales from the parallel universe of reality can be found here..
Atypical antipsychotics cause marked and rapid weight gain in kids
In children and adolescents, the so-called atypical antipsychotic agents lead to a marked and rapid weight gain, researchers said.
In a 12-week observational study of four of the newer drugs, the average weight gain was between 4.4 and 8.5 kilograms (9.7 and 18.7 lbs), depending on the agent, according to Christoph Correll, MD, of Zucker Hillside Hospital in Glen Oaks, N.Y., and Albert Einstein College of Medicine, and colleagues.
On the other hand, metabolic changes were less uniform, Correll and colleagues wrote in the Oct. 28 issue of the Journal of the American Medical Association.
The atypical agents -- also called second-generation antipsychotics -- are thought to be more effective than older drugs, but in a pediatric population, their cardiometabolic effects have not been well studied, the researchers said.
To help fill the gap, they studied 272 patients ages 4 through 18, who had not been previously treated with an antipsychotic drug. The Second-Generation Antipsychotic Treatment Indications, Effectiveness, and Tolerability in Youth (SATIETY) study took place between December 2001 and September 2007 at institutions in the borough of Queens, N.Y.
Patients were treated with aripiprazole (Abilify), olanzapine (Zyprexa), quetiapine (Seroquel), or risperidone (Risperdal) for 12 weeks. The 15 patients who refused to take part or did not adhere to the protocol served as a comparison group.
After a median of 10.8 weeks of treatment, the researchers found that weight increased by:
8.5 kg (18.7 lb) on average among the 45 patients taking olanzapine
6.1 kg (13.4 lb) among the 36 patients on quetiapine
5.3 kg (11.7 lb) among the 135 patients on risperidone
4.4 kg (9.7 lb) among the 41 patients on aripiprazole
0.2 kg (0.4 lb) in the untreated comparison group
All the weight gains were significant, compared with baseline weight, at P<0.001.
In a 12-week observational study of four of the newer drugs, the average weight gain was between 4.4 and 8.5 kilograms (9.7 and 18.7 lbs), depending on the agent, according to Christoph Correll, MD, of Zucker Hillside Hospital in Glen Oaks, N.Y., and Albert Einstein College of Medicine, and colleagues.
On the other hand, metabolic changes were less uniform, Correll and colleagues wrote in the Oct. 28 issue of the Journal of the American Medical Association.
The atypical agents -- also called second-generation antipsychotics -- are thought to be more effective than older drugs, but in a pediatric population, their cardiometabolic effects have not been well studied, the researchers said.
To help fill the gap, they studied 272 patients ages 4 through 18, who had not been previously treated with an antipsychotic drug. The Second-Generation Antipsychotic Treatment Indications, Effectiveness, and Tolerability in Youth (SATIETY) study took place between December 2001 and September 2007 at institutions in the borough of Queens, N.Y.
Patients were treated with aripiprazole (Abilify), olanzapine (Zyprexa), quetiapine (Seroquel), or risperidone (Risperdal) for 12 weeks. The 15 patients who refused to take part or did not adhere to the protocol served as a comparison group.
After a median of 10.8 weeks of treatment, the researchers found that weight increased by:
8.5 kg (18.7 lb) on average among the 45 patients taking olanzapine
6.1 kg (13.4 lb) among the 36 patients on quetiapine
5.3 kg (11.7 lb) among the 135 patients on risperidone
4.4 kg (9.7 lb) among the 41 patients on aripiprazole
0.2 kg (0.4 lb) in the untreated comparison group
All the weight gains were significant, compared with baseline weight, at P<0.001.
Tuesday, October 27, 2009
Wyeth - Premarin/Prempro: sealed with a kiss
A Philadelphia jury yesterday awarded punitive damages to an Illinois woman who said Wyeth's Prempro hormone replacement therapy caused her breast cancer, but the world will have to wait at least another month before anyone knows how much.
As the jury in Common Pleas Court was nearing a verdict on how much to award to punish Wyeth, which last week completed a merger with Pfizer Inc., company lawyers asked Judge Sandra Mazer Moss to seal the amount until a verdict is reached in a similar case also being tried in Philadelphia. The judge agreed.
In late September, the eight-person jury decided that Prempro caused Peoria, Ill., resident Connie Barton's invasive breast cancer and awarded her $3.7 million in compensatory damages. But the jurors also found that Wyeth intentionally ignored evidence that the drug could cause cancer and so awarded Barton, 64, punitive damages.
More
As the jury in Common Pleas Court was nearing a verdict on how much to award to punish Wyeth, which last week completed a merger with Pfizer Inc., company lawyers asked Judge Sandra Mazer Moss to seal the amount until a verdict is reached in a similar case also being tried in Philadelphia. The judge agreed.
In late September, the eight-person jury decided that Prempro caused Peoria, Ill., resident Connie Barton's invasive breast cancer and awarded her $3.7 million in compensatory damages. But the jurors also found that Wyeth intentionally ignored evidence that the drug could cause cancer and so awarded Barton, 64, punitive damages.
More
Monday, October 26, 2009
GAO Report - surrogate endpoints, ain't they a bitch!
Before approving a drug, the Food and Drug Administration (FDA) assesses a drug's effectiveness. This assessment may be based on evidence showing that a drug has a positive impact on a surrogate endpoint--a laboratory measure, such as blood pressure--instead of more direct clinical evidence, like preventing strokes.
After approval, FDA often requires or requests a drug sponsor to further study the drug. Concerns have been raised about FDA's reliance on surrogate endpoints and its oversight of postmarketing studies. This report provides information on (1) all drug applications approved based on surrogate endpoints in FDA's accelerated approval process, (2) a subset of applications for potentially innovative drugs approved based on surrogate endpoints under FDA's traditional process, and (3) FDA's oversight of postmarketing studies. GAO identified drugs approved based on surrogate endpoints, obtained the status of related postmarketing studies, and reviewed FDA's oversight of a sample of 35 studies it required under its accelerated approval process, selected to include studies which were at varying levels of completion.
FDA approved 90 applications for drugs based on surrogate endpoints through its accelerated approval process from the creation of the process in 1992 through November 20, 2008, and about two-thirds of postmarketing studies have been closed.
FDA created the accelerated approval process to expedite the approval of drugs which are designed to treat serious or life-threatening illnesses and are expected to provide meaningful therapeutic benefits compared to existing treatments. Under this process, 79 of the 90 applications were approved for drugs to treat cancer, HIV/AIDS, and inhalation anthrax. Because of the need to expedite approval, FDA approves drugs under this process based on surrogate endpoints which are not yet proven substitutes for clinical endpoints, but does require that drug sponsors complete postmarketing studies to confirm the drug's clinical benefit. FDA had required drug sponsors to conduct 144 postmarketing confirmatory studies associated with these 90 applications, and as of December 19, 2008, classified 64 percent as closed--meaning that drug sponsors had met FDA's requirements for these studies or FDA determined the studies were no longer needed or feasible.
However, several of the remaining studies have been classified by FDA as open for an extended period. FDA approved 69 applications on the basis of surrogate endpoints for new molecular entities (NME)--potentially innovative drugs containing active chemical substances that have never been approved for marketing in the United States in any form--through its traditional approval process from January 1998 through June 30, 2008. These 69 NME drugs accounted for about one-third of the 204 applications for NME drugs which FDA approved through its traditional process during this period, many for drugs to treat cancer, heart disease, and diabetes. Unlike surrogate endpoints used in the accelerated process, FDA considers those used in the traditional process as valid substitutes for demonstrating the clinical benefit of drugs, and thus does not require sponsors to complete postmarketing confirmatory studies. However, FDA requested that sponsors complete 175 postmarketing studies to obtain other information on many of these NME drugs, and as of February 13, 2009, FDA classified about one-half as closed.
Weaknesses in FDA's monitoring and enforcement process hamper its ability to effectively oversee postmarketing studies. FDA has not routinely been reviewing sponsors' annual submissions on the status of studies in a timely manner. It has little in the way of readily accessible, comprehensive data to monitor studies' progression and does not consider such oversight a priority. FDA is implementing initiatives to improve its oversight, but it is too early to tell if they will be effective. Although FDA has authority to expedite the withdrawal of a drug from the market if a sponsor does not complete a required confirmatory study with due diligence, or if a study fails to confirm a drug's clinical benefit, it has not specified the conditions thatwould prompt it to do so. It has never exercised its authority, even when such study requirements have gone unfulfilled for nearly 13 years.
Joint working with the pharmaceutical industry - Health Service Journal
YOUR IDEAS AND SUGGESTIONS
Joint working with the pharmaceutical industry
26 October, 2009
Steve Williamson, Sean McGrath and Abbie Pound explore the importance of collaborative working between healthcare providers and the pharmaceutical industry - facilitated by medical education agencies - and what this might mean for patient care
The NHS and the pharmaceutical industry have pinned their colours squarely to the mast of collaborative working in their joint production of Moving Beyond Sponsorship.
This online tool provides practical advice on joint working and is the culmination of a series of advisory and guidance documents from both sides of the divide. It highlights the importance of mutual trust, with the ultimate aim of improving patient care.
Although not the first example of collaboration, it is hoped that the toolkit will mark an about turn in the culture of cynicism that often surrounds such joint working.
As with other examples of collaborative work, this initiative is most likely to succeed if facilitated and nurtured by a medical communications agency. These agencies “speak the same language” as clinicians and pharmaceutical companies, and understand the professional and regulatory pressures under which both work. The communication channels they provide can make the difference between a strong, worthwhile joint project and one that falls at the starting blocks.
A new culture
The shift in the culture of joint working between the two sectors was welcomed earlier this year in The Lancet, when the editor, Richard Horton, argued that symbiosis, rather than schism, between the NHS and the pharmaceutical industry would provide the best deal for patients. He urged clinicians to stop being dependent on industry, and instead seek to promote relationships based on trust, respect and confidence.
Mr Horton is just one of many commentators to hope the current climate marks a sea change in the relationship between the NHS and the pharmaceutical industry.
NHS professionals are often cynical about the high stakes of the NHS drugs market. Then there are the David and Goliath proportions of the players: on one hand, the cash-strapped primary care organisation, pleased to have a few “sponsored” sandwiches at one of its educational seminars; on the other, the image of the international corporation, with “vested interest” branded on every iota of its largesse.
Many healthcare professionals question why some drugs are so expensive, particularly when marketed to a not-for-profit organisation. In their defence, pharmaceutical companies cite high research and development costs, limited drug patent life and the difficulty of setting a lower basic price for the small UK market, compared with other healthcare marketplaces, including the USA.
Now, with the NHS in its seventh decade, there are encouraging signs that the sellers and buyers in the healthcare marketplace are prepared to put real effort into working together, openly, with probity, and with the clearly stated aim of benefiting all the stakeholders - the NHS, industry and patients.
What is joint working?
The definition of joint working used in Moving Beyond Sponsorship is highly specific (see below), and excludes many worthwhile initiatives that are already in place. This article takes a broader view of collaborative work designed to improve patient access to effective treatments.
Local initiatives
Steps towards joint working have been made around the country, at local level, with agreements reached between commissioners and pharmaceutical companies on, for instance, funding educational schemes and deals to reduce drug acquisition costs.
One good example is the North of England cancer drugs approval group, which spans two strategic health authorities and serves a population of about 3.2 million people.
The group approved the use of sunitinib for the treatment of renal cell cancer in July 2007 under a special deal. The drug is supplied free for the first month, then at a 5 per cent discount. Sunitinib was not made available to NHS patients nationally until early 2009, and the decision could not have been made without a change in the rules governing certain appraisals by the National Institute for Health and Clinical Excellence.
The North of England cancer drugs approval group model of working with industry
- The group was formed in May 2006 to ensure that all patients with cancer in the North East of England and Cumbria receive equitable access to a clinically defined range of cancer medicines.
- The group serves all of the North of England cancer network organisations, encompassing nine acute trusts, five primary care organisations, two strategic health authorities and a population of around 3.2 million.
- It has delegated authority from commissioners across the North East to approve or reject drugs presented for consideration.
- The group meets four to five times a year to consider applications for curative and palliative drugs that are not in the NICE system and/or are ore than six months away from being appraised by NICE.
The North of England cancer drugs approval group has:
- Backing and support from both strategic health authorities
- Expertise and support of the network
- Clinical involvement from oncologists
- Buy-in from primary care organisations to collective decision making to ensure equity for patients
- Strong leadership and close links with NHS senior management
The national picture
Looking at the national picture, it can be argued that the formation of health technology appraisal organisations, notably NICE in 1999, was a key step towards improving patient access to drugs and providing a forum for dialogue between the NHS and the pharmaceutical industry.
In the past two years or so, the scope of that dialogue has been extended to include the possibility of special deals designed to make treatments more affordable to the NHS without an explicit cut in the basic per-unit price.
June 2007 marked the first of these special patient-access deals, when bortezomib was made available for the NHS treatment of multiple myeloma, but the manufacturer agreed to refund the cost for patients who responded marginally or not at all.
Just over a year later, in August 2008, NICE approved ranibizumab as an option for the treatment of wet age-related macular degeneration, on the premise that the manufacturer would meet the cost for treatment that went beyond 14 injections.
Similar deals have followed, extending patient access to treatments that NICE would otherwise consider too expensive, in terms of cost per quality-adjusted life year (QALY).
However, occasional local and national schemes are not enough. They can lead to a perception that patient access is improved for some - potential recipients of the small number of drugs covered by a NICE special deal and those fortunate enough to live in areas where commissioners negotiate with pharmaceutical companies.
The old bugbear of postcode prescribing - which NICE was originally supposed to end - is still looming large. Furthermore, there remains a strong perception that new (expensive) drugs are the preserve of those who can pay for them, or those who have health insurance.
It was in the face of these and other, related challenges, that various key national documents were issued in 2008 and early 2009, notably:
- Improving Access to Medicines for NHS Patients, by national cancer director Mike Richards
- NICE advice on approval of drugs for end of life care
- Guidance on joint working between the NHS and pharmaceutical companies, issued by the NHS and the Association of the British Pharmaceutical Industry
- Moving Beyond Sponsorship: interactive toolkit for joint working between the NHS and the pharmaceutical industry, issued jointly by the Department of Health, the NHS and the ABPI (March 2008)
Mike Richards’ report
Professor Richards’ much-awaited 2008 report on patient access to drugs was triggered by the debate over NHS care for patients who pay for part of their treatment privately. He focused on cancer treatments in particular, but his recommendations are applicable to all new, high-cost medicines that come into the marketplace.
The report included the following recommendations:
- NICE should review its criteria for deciding cost effectiveness limits for patients receiving end of life care.
- The Department of Health should encourage primary care trusts to work collaboratively when making commissioning decisions, citing NECDAG as an example of good practice.
- When making commissioning decisions, it is essential to be transparent and consistent.
- The NHS needs to work with the pharmaceutical industry and to adopt more flexible approaches to pricing of and access to new drugs.
Professor Richards’ overarching message is that, to improve patients’ access to high-cost medicines, the NHS must look to its own organisation, strengthen its own decision-making processes and work collaboratively with the pharmaceutical industry.
NICE decision on end of life care
In January 2009, NICE advised its appraisal committees that they could consider approving certain treatments for use in patients nearing the end of life, even if the cost per QALY exceeded the current benchmark (£30,000). The criteria for approval are as follows:
- Patient life expectancy should be no more than about 24 months.
- There must be evidence that the treatment is likely to extend life by at least three months, compared with treatments currently available via the NHS.
- There should be no comparable alternative treatment already approved for use via the NHS.
- The treatment will benefit only a small patient population.
One current example of NICE implementing its new end of life care principles, while at the same time collaborating with a pharmaceutical company on a cost-capping deal, is the guidance on the use of lenalidomide in patients with refractory multiple myeloma. In its appraisal, NICE states that lenalidomide fulfils the criteria for approval of end of life care, and approves an offer from the manufacturer to meet the continuing cost of the drug for any patient whose treatment persists beyond 26 cycles (typically two years). The flexibility and joint working practices that have underpinned the lenalidomide decision benefits the following stakeholders:
- Patients - about 2,100 patients in England and Wales have access to a life-extending treatment hitherto unavailable under the NHS.
- The NHS - NICE estimates that 17 per cent of patients eligible for lenalidomide under its criteria will continue to receive the treatment beyond the 26-cycle threshold, when the cost of the drug will be met by the manufacturer.
- The drug company gains an NHS market for its drug.
Government and ABPI guidance
In their recent toolkit for joint working, the NHS, Department of Health and ABPI take pains to explain why the new move towards collaboration is not simply another way of looking at drug company sponsorship of healthcare initiatives. It states that:
- Sponsorship means simply providing funds for a specific event or work programme.
- In joint working, goals are agreed by the NHS organisation and company, in the interests of patients, and shared throughout the project. It requires joint participation in management of the project and open and transparent working.
In its accompanying guidance document, the ABPI stresses that both the NHS organisation and the drug company must make a significant contribution to the project, in terms of, for example, people, other resources, equipment, communication channels or money. There must be no suggestion that the arrangement can be construed as a gift or donation of services.
Many of the collaborative ventures that NHS organisations and drug companies are currently engaged in do not qualify as joint working practices under the toolkit’s definition. These include funding of clinical trials, provision of equipment or nurse support to help administer a specific treatment, sponsorship of meetings and hospitality and educational grants.
Examples of initiatives that may qualify as joint working include:
- Staff training
- Staff or patient education
- Economic analysis
- Pathway redesign
- Guideline implementation
- Audit
The authors of the toolkit guide would be collaborators through the stages of setting up, implementing and monitoring a shared project. They also provide several examples of good practice in joint working, with contact details for individuals from both sides of the NHS/industry divide.
The toolkit acknowledges that, compared with sponsorship, joint working will require a different, more collaborative approach from both parties, based on:
- Shared vision of the aims and outcomes, e.g. reduced morbidity, fewer hospital visits
- Equity, i.e. recognition that each party has a right to have their say, and that there is an interdependent relationship between both of the organisations involved
- Transparency, including sharing of information
- Mutual benefit
- Respect between the organisations
For those who worry that the government/ABPI joint working scheme is based on a rose-tinted view of how the NHS and the pharmaceutical industry regard each other, the toolkit presents the findings of a survey that identifies some of the negative and positive attitudes that staff in the two sectors have towards each other (Table 1). It warns that some of the stereotypical ideas can be unproductive for those intent on joint working, and emphasises the need for mutual respect and recognition of each other’s differences.
Table 1. Preconceptions that NHS and pharmaceutical industry staff have about each other
NHS views of industry Industry views of the NHS Positive Innovative
Forward thinking
Proactive
Supportive
Informative
Organised
Respectful
Innovative
Forward thinking
Committed
Approachable
Aware of NHS limitations
Organised
Respectful
Negative Pushy
Insensitive
Inflexible
Aggressive (in marketing)
Irritating
Untrustworthy
Obstructive
Outdated
Inaccessible
Mistrustful
Disorganised
Uncooperative
What can a third party contribute?
Effective communication is probably the biggest challenge for any NHS team and drug company seeking to establish a collaborative venture, whether it comes under the new government/ABPI definition of joint working or owes more to the older concept of sponsorship. A medical communications agency can overcome the hurdles to communication, not least those generated by some of the preconceptions listed in Table 1.
The contributions that a medical education/communications agency can make are many and varied. They include:
- Compilation of market access information, whereby key details about a drug not yet in the NICE appraisal system can be communicated in advance to commissioners, allowing them to consider and plan for its potential impact on, for example, service capacity
- Identification, through facilitated discussion, of opportunities for joint projects likely to benefit all parties
- Organisation and facilitation of educational events
- Production of key documents, reflecting the viewpoints of both parties
- Acting as a neutral arbiter, if needed
To fulfil this role, the agency must:
- Understand the differing needs and attitudes of the NHS organisation and the drug company
- Have a detailed knowledge of the ABPI code, which regulates all promotional and some non-promotional activities undertaken by the pharmaceutical industry, and the professional ethos of NHS staff
- Understand the workings of the NHS and the constraints on health professionals’ time and other resources
Although some healthcare professionals may still be cynical about joint working between the NHS and the pharmaceutical industry, it is clear that collaborative ventures have already helped to improve patient care.
When joint working is contemplated, medical education/communication agencies can bring specialist knowledge and skills to the negotiating table. They already help NHS teams and drug companies forge and maintain effective working relationships, and the role of these agencies is likely to expand as the new joint working initiative takes hold.
NHS North East has shown what can be achieved when a forward-thinking, co-operative approach is taken to working with the pharmaceutical industry. Joint working benefits all stakeholders, but the principal beneficiaries are the patients.
Source:
Steven Williamson is a consultant pharmacist in cancer services, Northumbria Healthcare. Sean McGrath is managing director and Abbie Pound is editorial and publications manager of Succinct Healthcare Communications and Consultancy.
via hsj.co.uk
MeReC Monthly
The new issue of MeReC Monthly, produced by the UK National Prescribing Centre is now available. Click the link below to read the full publication where there is also a pdf available to download.
Topics include:
- Even limited exposure to pharmaceutical promotion may influence prescribing habits
- Inadequate sample size calculation and reporting in clinical trials
- Press releases may not reflect the limited clinical relevance and usefulness of research
- Beware citation bias
Pharma Seeks Cure For Off-Label Woes - Yahoo! Finance
There's a chance your doctor will prescribe a drug approved for a related or even different disease.
Doctors prescribe off-label drugs frequently. It's legal.
They make the call based on knowledge of the drug's prospective capabilities, the disease itself and on information colleagues may have shared in journals, conversation or online.
But woe betide a company that promotes a drug for an as-yet unapproved purpose. The Food and Drug Administration and Department of Justice won't like it.
It's one thing for a doctor to make a judgment call and suggest off-label use to a patient. It's quite another for a drug firm to suggest, imply, hint or wink-wink-nudge-nudge the doctor to do it.
"The industry gets into big trouble for anything the FDA perceives as promotion of off-label use," said Joel Hay, professor of pharmaceutical economics at the University of Southern California.
A Fine Mess For Pfizer
How big is that trouble? Just ask Pfizer (NYSE:PFE - News).
Last month, the company concluded a settlement with the Justice Department in which it pleaded guilty to criminal charges resulting from off-label promotion of its now-withdrawn Bextra pain drug.
The fine was a record $2.3 billion to settle both criminal and civil charges relating to Bextra and 13 other products. It was levied after Pfizer was deemed a repeat offender in marketing drugs to patients and doctors for unapproved conditions.
Pfizer withdrew Bextra, a painkiller, in 2005. Pfizer's marketing team promoted the drug for acute pain, surgical pain and other unapproved uses. Meanwhile, sales reps promoted the drug directly to physicians for those unapproved uses and dosages, according to the Justice Department.
In the settlement, Pfizer agreed to a corporate integrity program monitored by the Department of Health and Human Services.
It wasn't Pfizer's first offense. In 2004, the company pleaded guilty to criminal charges of illegally marketing epilepsy drug Neurontin for migraine headaches, pain and bipolar disorder. Pfizer paid $430 million to federal and state governments.
Paying $2.3 billion on the latest charges hurts but doesn't cripple Pfizer. With its recent acquisition of Wyeth, the firm's market cap is $118 billion and its annual revenue is $46 billion.
Until the latest Pfizer settlement, the biggest penalty had been the $1.4 billion Eli Lilly (NYSE:LLY - News) paid in January for off-label promotion of its Zyprexa schizophrenia drug.
Again, a serious amount, but not devastating to Lilly, which boasts a market cap of $39 billion and sales of $21 billion.
Still, it's enough to cause one biopharma to take preemptive action.
On Oct. 1, Allergan (NYSE:AGN - News) filed a lawsuit against the FDA contending that the agency's ban on off-label marketing violates the firm's First Amendment free speech rights.
Allergan wants to be able to tell doctors what Botox can and can't do for conditions beyond those for which the FDA approved it.
Citing a 2006 study reported in the Archives of Internal Medicine, Allergan said in its statement that "it is estimated that approximately 20% of all prescriptions in the United States are used by physicians for off-label indications and are often used to treat very serious conditions such as cancer and AIDS."
Allergan, with a market cap of $17.5 billion, is responding to the FDA's crackdown on off-label marketing, says Gary Nachman, analyst with Leerink Swann.
The company says its lawsuit is aimed at removing limits on promoting Botox for as-yet unapproved uses, and has no link to a federal investigation started in 2008 into Allergan's previous off-label Botox marketing.
In a press release, Allergan says it wants to give important information to doctors who might use Botox off-label.
The company wants the legal right to "proactively provide comprehensive information to physicians about ... off-label uses, such as dosing guidelines, patient selection criteria and proper injection technique."
Botox is a key Allergan product, with 2008 sales of $1.3 billion. It's best-known for its approved use to smooth out facial wrinkles.
Wrinkle-smoothing is not a medical necessity. Customers are stretching out the intervals between treatments, and sales are down by more than 3%.
Botox is also approved for severe neck spasm and pain, eyelid twitching, misaligned eyes and excessive perspiration.
Strong Warnings Mandated
The FDA said in April that Botox and competing products must carry strong warnings that the toxin can spread in the body. The FDA acted on reports that deaths had occurred from botulinum toxin injected for unapproved uses.
In 2008, half of Allergan's Botox sales were for cosmetic use and half for therapeutic. This year, therapeutic use will account for 55% of Botox sales, Nachman says.
Other possible, but not approved, uses for Botox include post-stroke spasticity, migraine and over-active bladder. The drug also might help children with juvenile cerebral palsy, analyst Nachman says, but too great a dose could cause respiratory failure.
An FDA clampdown on off-label marketing won't stop off-label use. Nor should it, says Les Funtleyder, analyst with Miller Tabak and author of the book, "Healthcare Investing: Profiting from the New World of Pharma, Biotech, and Health Care Services."
Off-label prescribing can serve a useful purpose. It can give drugmakers insights into possibilities for new therapeutic uses for which it was not tested. And it doesn't cost drugmakers anything.
"The less they spend, the better they feel," Funtleyder said.
Balancing Act
The trick comes in balancing two objectives, he says. One is to learn more about drugs to improve patient health. The other is not to endanger patients.
Allergan bolsters its argument for responsible off-label information by pointing out that both government and private-sector insurers reimburse for many off-label drug uses, including off-label uses of Botox for certain types of adult and juvenile spasticity.
There's nothing to prohibit a doctor from prescribing any legal medication for a patient. Chemotherapy drugs are used almost totally off-label, USC's Hay says.
Amgen's (NasdaqGS:AMGN - News) cancer drug Avastin was used in low doses off-label to treat wet age-related macular degeneration until Amgen developed Lucentis, its own low-dose Avastin, for that purpose.
There's also nothing illegal in a drug firm's doing or sponsoring research into off-label uses, and nothing illegal about publishing the results, Hay says.
Nor is there anything illegal in doctors communicating their findings to each other in any way. They do that in person, in journals and through online social networking.
However, such information will be anecdotal, not scientific.
"It's unlikely to conclusively demonstrate the value of any therapy," Hay said.
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