We all love it when we get something free. Cosmetics companies, Costco and even fast-food chains have learned that free stuff creates good will, loyalty and higher satisfaction. Perhaps nobody knows this better than pharmaceutical companies, which have used the "free sample" as a backbone of their $9 billion marketing strategy.
Well-dressed, attractive pharmaceutical sales representatives from the army of 88,000 constantly bounce into doctors' offices across the country, smiling and bringing gifts – and leaving behind free samples of drugs for doctors to give to patients.
Not a bad deal. Or is it?
Americans pay the highest prices in the world for medicines. The identical drug costs a fraction as much in other nations as here. Many drugs are lifesavers, and the huge jump in Americans' life expectancy achieved over the past 100 years was in large part due to medicines, particularly antibiotics.
But a huge part of pharmaceutical companies' budgets goes to promotion and advertising rather than research and development of new drugs. In fact, the majority of drugs developed and tested each year are what I call "me too" drugs – they behave nearly identically to drugs already on the market.
A large part of the drug-promotion budget goes to free drug samples given to doctors – over $15 billion a year worth at the last count. Why do doctors love free samples for their patients? They mistakenly believe they are doing something good for their patients by giving them something for free. They also mistakenly believe these freebies save people money and perhaps even eliminate a trip to the drugstore.
In fact, neither is true.
Who do you think pays for those free samples? Not stockholders or company executives, but sick people who buy drugs. Also, the free samples the doctor gets from the sales reps are not samples of inexpensive drugs or drugs that have been on the market for a long time and are known to be safe and effective. Rather, the samples are of the newest drugs on the block – ones that have limited safety records, are extremely expensive and are usually no better than drugs that cost one-fourth or sometimes one-tenth as much.
The task for drug companies is clear but difficult: Get doctors to turn from prescribing the usual diabetes medicines, blood pressure medicines, antibiotics and antidepressants, and start prescribing the company's new drug. Since few, if any, of these drugs have large benefits over older medications, the best way to motivate doctors is through free samples.
Guess what happens when the few days' worth of free samples given to a patient runs out? Studies show the doctor rarely writes a prescription for the same drug the patient has always used. Instead, since the patient started a new medicine, the doctor continues to use that expensive drug – and it is likely it's not even covered by the patient's insurance company.
So as my mother always told me, nothing is really free. In the case of drug samples, you are almost always better off refusing the free sample and asking your doctor to prescribe a drug that has been around for a while. It may mean a trip to the pharmacy, but you're almost certainly going to end up there either way.
This way, you'll get the best drug for the best price, not the one that drug companies want you to have to boost their profits.
© Copyright The Sacramento Bee. All rights reserved.
Michael Wilkes, M.D., is a professor of medicine at the University of California, Davis. Reach him at drwilkes@sacbee.com.
Sunday, January 31, 2010
Inside Medicine: Samples of drugs aren't free - Sacramento Bee
Homeopathy: medicine that's hard to swallow? - Telegraph
David Colquhoun, professor of pharmacology at University College London, has long been concerned about the rising popularity of homeopathy. When he passes a chemist, he likes to carry out an experiment, asking the pharmacist what natural remedy they would recommend for his sickly grandchild, who has suffered from "terrible diarrhoea for days". Just one in 10 chemists advises him to send the child to a doctor immediately, or choose a conventional rehydration treatment – the course of action recommended by the medical profession.
"It's terrifying," says Prof Colquhoun. "Any sensible parent would be searching out Dioralyte, but nine out of 10 times the pharmacists will start rummaging through the homepathic shelves."
via telegraph.co.uk
Glaxo Smith Kline set to slash 4,000 jobs - Times Online
The bulk of the cuts will be in America and Europe, and are part of the company’s efforts to shift resources away from low-growth territories into parts of the world with greater scope to expand sales.
via business.timesonline.co.uk
Saturday, January 30, 2010
FDA's new warning on atypical antipsychotics and adolescents
The Federal Drug Administration on Friday issued a warning to doctors that adolescents taking the drug olanzapine have an "increased potential" -- in comparison with adults taking the new-generation antipsychotic drug -- for weight gain and metabolic disturbances that could result in diabetes or elevated blood cholesterol levels.
"Clinicians should consider the potential long-term risks when prescribing to adolescents," the FDA said in a statement released Friday night. "In many cases, this may lead to prescribe other drugs first," the statement went on.
The agency has not approved the marketing of olanzapine -- sold under the commercial nameZyprexa by the drug maker Eli Lilly -- for use in children under 13 who are diagnosed withschizophrenia or bipolar disorder. But the medication, one of a class of psychiatric medications called the "atypical antipsychotics," is widely prescribed for young patients, despite growing evidence that call its safety profile into question for this population.
The warning comes in the wake of the October publication in the Journal of the American Medical Assn., in which a study showed that children and adolescents taking their first-ever course of Zyprexa gained, on average, more than 17 pounds over a 12-week period, as well as dramatic increases in triglycerides and cholesterol levels -- all factors that put them at higher risk of developing cardiovascular disease. While two other antipsychotic drugs -- Seroquel and Risperdal -- were implicated in significant weight gain and metabolic changes, Zyprexa was found to carry the highest risks of all three.
The FDA said that in cases where physicians opt to prescribe olanzapine, the drug should be part of a "comprehensive treatment program," which could include psychological, educational and social counseling as well as medication therapy.
Today is OD Day - Jack Friday will be there!
An Open Letter to Alliance Boots
The Boots brand is synonymous with health care in the United Kingdom. Your website speaks proudly about your role as a health care provider and your commitment to deliver exceptional patient care. For many people, you are their first resource for medical advice; and their chosen dispensary for prescription and non-prescription medicines. The British public trusts Boots.
However, in evidence given recently to the Commons Science and Technology Committee, you admitted that you do not believe homeopathy to be efficacious. Despite this, homeopathic products are offered for sale in Boots pharmacies – many of them bearing the trusted Boots brand.
Not only is this two-hundred-year-old pseudo-therapy implausible, it is scientifically absurd. The purported mechanisms of action fly in the face of our understanding of chemistry, physics, pharmacology and physiology. As you are aware, the best and most rigorous scientific research concludes that homeopathy offers no therapeutic effect beyond placebo, but you continue to sell these products regardless because "customers believe they work". Is this the standard you set for yourselves?
The majority of people do not have the time or inclination to check whether the scientific literature supports the claims of efficacy made by products such as homeopathy. We trust brands such as Boots to check the facts for us, to provide sound medical advice that is in our interest and supply only those products with a demonstrable medical benefit.
We don't expect to find products on the shelf at our local pharmacy which do not work.
Not only are these products ineffective, they can also be dangerous. Patients may delay seeking proper medical assistance because they believe homeopathy can treat their condition. Until recently, the Boots website even went so far as to tell patients that "after taking a homeopathic medicine your symptoms may become slightly worse," and that this is "a sign that the body's natural energies have started to counteract the illness". Advice such as this directly encourages patients to wait before seeking real medical attention, even when their condition deteriorates.
We call upon Boots to withdraw all homeopathic products from your shelves. You should not be involved in the sale of ineffective products, because your customers trust you to do what is right for their health. Surely you agree that your commitment to excellent patient care is better served by supplying only those products whose claims can be substantiated by rigorous scientific research? Or do you really believe that Boots should be in the business of selling placebos to the sick and the injured?
The support lent by Boots to this quack therapy contributes directly to its acceptance as a valid medical treatment by the British public, acceptance it does not warrant and support it does not deserve. Please do the right thing, and remove this bogus therapy from your shelves.
Yours sincerely,
The Merseyside Skeptics Society
It is often when they go wrong that medicines remind you how powerful they are.
Brittany Murphy, the actress who recently died at age 32, had no alcohol, illegal drugs, or paraphernalia in her room, but she had Topamax, Methylprednisolone, Fluoxetine, Klonopin, Carbamazepine, Ativan, Propranolol, Biaxin, and Hydrocodone.
Source
"Drug marketing is a very sophisticated system which corrupts every part of the scientific and medical network,"
A FLINDERS University study has exposed "corrupt" drug company marketing practices including covering up adverse side effects and pushing patients on to new, more expensive drugs even when they are less effective.
Psychiatrist Peter Parry and American colleague Glen Spielmans studied 400 internal emails and research documents unearthed mainly through court cases.
"Drug marketing is a very sophisticated system which corrupts every part of the scientific and medical network," Dr Parry said.
Dr Parry said one disturbing finding was that, regardless of the health benefits, drug companies were pushing patients towards their own patented drugs because they could make bigger profits. Such products were called "blockbuster drugs" in the industry because they could make more than $1 billion in profits.
The documents, sourced from US and European companies which also market and sell their products in Australia, indicate:
INSTRUCTIONS to sales representatives not to mention weight gain side effects of the drug Zyprexa.
HIDING the weight-gain side effects of anti-psychotic drug Seroquel.
EXAGGERATING the benefits of Seroquel over an existing medication.
DISTORTION of research trials by excluding the results of some patients, not publishing the findings or making up statistical reasons to exclude some "bad apple" results.
GHOST writing of medical journal articles by marketers with the names of doctors used as "honorary" authors.
All of the drug companies involved rejected the conclusions of the study, published in the journal Bioethical Inquiry, arguing the documents on which it is based are taken out of context as evidence in court cases.
Dr Parry said while he supported the use of drugs in psychiatry, all results of research should be made available to prescribing doctors.Source
Friday, January 29, 2010
AstraZeneca - Seroquel: remember that $520 million "settlement" with the US Attorney's Office
Well, it just went up to $524 million!
AstraZeneca faces costs of up to $1.2bn from the escalating number of legal cases brought by patients and regulators suing it over alleged improper marketing and side effects caused by Seroquel , its blockbuster antipsychotic drug that generated $4.9bn in sales last year.
In its fourth quarter, the group boosted provisions to $524m for a settlement with the US Attorney's Office investigation into sales and marketing practices of Seroquel.More from Andrew Jack at the FT
Thursday, January 28, 2010
Lilly - Effient: customer feedback; the breakfast of champions!
The controversial price for new Effient (prasugrel)
Eli Lilly is now launching the newly approved Effient (prasugrel). The company set nearly a 100% price premium for Effient over Plavix ($5.7 per Effient pill versus $3 per Plavix pill), despite the black box warnings on Effient. This comes at a time when healthcare reform talks are at a peak and drug price negotiations by Medicare Part D are “on the table” as a way to fund the reform bill.
The Healthcare Channel interviewed William O’Neill, Executive Dean for Clinical Affairs at the University of Miami School of Medicine. Dr. O’Neill is upset at the price for Effient and discusses how it is now common for his medical center to treat patients that cannot afford the price for oral medications.
Register on http://thehcc.tv/ to view the story.
The Healthcare Channel on http://thehcc.tv/
New York, New York - the scandal and the price!
The companies, which also include Mylan Inc. and units of Teva Pharmaceutical Industries Ltd. and Novartis AG, unlawfully obtained public funds for health care providers by making false statements about prices for nine drugs, District Judge Patti Saris in Boston ruled yesterday. The judge will hold a separate hearing on damages, which may be tripled under state law.
New York City and the counties claimed the drug companies illegally sought to increase market share by selling medicines to physicians at steep discounts to “Average Wholesale Prices” they published. Medicare and Medicaid used the posted prices to establish reimbursement rates for doctors. By inflating AWPs, the companies artificially boosted the payments, Saris said.
The drug companies “attempted to obtain payment from public funds on behalf of providers by means of a materially false statement or representation,” Saris said in her order. “There is simply no evidence that defendants believed that the prices they reported were even true list prices.”More at Bloomberg
AstraZeneca to cut 8,000 more jobs
Pharmaceutical giant AstraZeneca is to cut a further 8,000 jobs across its worldwide operations.
The workforce reduction is in addition to the 12,600 global positions that have already been trimmed under the firm's continuing cost-cutting plans.
The UK group said the latest round of job cuts would be implemented over the next four years.More
Pfizer's "Invest to Win" cuts
Pfizer has released details of its new consolidated pipeline following its merger with Wyeth, announcing new priority research areas, and the abandonment of 100 less promising projects.
The company says it wants to be the market leader in six areas of research and as well as in the broader fields of vaccines and biologics.
The six key “Invest to Win” therapy areas are: oncology, pain, inflammation, Alzheimer’s disease, psychoses and diabetes.
The company’s pipeline now includes a total of six vaccines and 27 biologics, up from one vaccine and 16 biologics from the previous pipeline update in March 2009.
The company has cut a total of 100 existing projects create its new ‘prioritised portfolio’ with approximately 70% of Pfizer’s research projects and 75% of the late-stage portfolio focused on these areas.More
Wednesday, January 27, 2010
Franklin Co. judge awards $5.3 million in penalties against AstraZeneca
Franklin Circuit Court Judge Roger Crittenden has awarded $5.3 million in civil penalties against the pharmaceutical company AstraZeneca for violating Kentucky's Consumer Protection Act.
In October 2009, a jury handed down at $14.7 million verdict against AstraZeneca for defrauding the Medicaid program and Kentucky consumers by inflating the prices of their prescription drugs.
Crittenden found 5,391 violations of the Kentucky Consumer Protection Act and awarded $1,000 per violation for a total civil penalty of $5,391,000.
Pharma Giles writes ...
Shock as Novartis CEO stands down.
The pharmaceutical industry grapevine was abuzz with the news that Saint Daniel of Vasella has decided to stand down from his position as principal deity of pharmaceutical giant Novartis.
”I feel it is time to acknowledge the concerns of the Archbishopric and to therefore relinquish my role as God The Father,” said St. Daniel to the shocked and tearful worshippers assembled at the annual Novartis General Synod yesterday.
“However, I will still continue in my ordained capacities as God The Son and God The Holy Ghost,” the Anointed One continued.
“I leave my heavenly mountain abode at the height of the company’s success, secure in the knowledge that the only direction the fortunes of Novartis will be taking in future is an Earthward one,” He said. “And I also get to side-step the fall-out from our off-label marketing scams.”
“Now let us read from the Book of St. Garnier The Unrepentant.”
“2For I, your leader, have committed the sin of being too successful.
3Verily has our company waxed fruitful, and yea does its R&D portfolio bear a bountiful harvest whilst all around, other lands are turned to dust.”
“4Yet I do not worship at the Pharmaceutical Temple of Outsourcing To Asia, nor at the Holy Shrine of Mass Downsizing, as is the fashion of our neighbours”.
”5And so it is with a heavy heart that I decree that it is time for the Church of Novartis to become like unto our industry brethren.”
“6Henceforth, we shall abandon the Pursuit of Excellence in exchange for the Pursuit of Mammon and the Holy Grail of Bigger Shareholder Returns.”
“7To this end I commend you to the care of His Holiness, Lord Voldemort of Heinz. 8Lord Voldemort’s experience of our industry is second to everyone’s and yet, yea, I proclaim this to be of no consequence.”
“9For Lord Voldemort is that most Holy of Men, an MBA from Harvard with marketing experience, as is so desired by our shareholders.”
“10May God Help this company, and all those who worship at its alter…”
11And thus did St Daniel cast off his mantle of greatness, and wander lonely into the desert of Public Office, consoled only by a multi-million dollar golden parachute.
12And Saint McKinnell looked down from the glory of obscene severance terms and said: “It Is Good”.
Similarly biblical tales can be found here.
Jean Pierre Garnier, Fred Hassan and now Dan Vasella. Who will keep us entertained once the industry's "characters" have retired into luxury?
AstraZeneca - Seroquel: weighty problems continue: now the FT joins in!
Several academic studies pre-dating the advertisement suggested Seroquel did not carry a lower risk of weight gain than other antipsychotics. One, published in 2000 in the journal Acta Psychiatrica Scandinavica, concluded: “All atypical drugs, with the exception of ziprasidone, have been associated with weight increases. Clozapine seems to have the highest risk of weight gain, followed by olanzapine and quetiapine [Seroquel]. There is probably a lower risk with risperidone, sertindole and zotepine and a still lower risk with amisulpride.”
Much more at the FT
Orgasm Inc - The Movie
No joke - if you click on "trailer" it says "coming soon"!
Filmmaker Liz Canner takes on the "strange science of female pleasure" and how pharmaceutical companies hope to capitalize on it in her documentary, Orgasm, Inc.
More, more, more!
Tuesday, January 26, 2010
Novartis Says U.S. Unit to Pay Fine
By JEANNE WHALEN
Swiss drug giant Novartis AG said its U.S. subsidiary struck a plea agreement with U.S. investigators to resolve criminal allegations regarding the company's promotion of the epilepsy drug Trileptal, and agreed to pay a $185 million fine.
Federal investigators have been carrying out civil and criminal investigations of Novartis' marketing of the drug, including allegations that it promoted the drug for uses for which it is not approved by the Food and Drug Administration, an illegal practice known as "off-label" marketing, Novartis said in a statement Tuesday as it announced fourth-quarter results.
The investigations have also scrutinized "payments made to health-care providers in connection with this medicine," Novartis said. The company had previously disclosed the existence of the investigation, which is being led by the U.S. Attorney's Office for the Eastern District of Pennsylvania.
To resolve criminal allegations, Novartis said it agreed to plead guilty to a violation of the U.S. Food, Drug and Cosmetic Act, and to pay a fine of $185 million. This agreement is "contingent on court approval," Novartis said.
Separately, Novartis said it is still negotiating with the investigators "to resolve civil claims relating to Trileptal." In a sign that a civil settlement could be close, Novartis said it increased its provisions relating to the Trileptal investigations by $318 million in the fourth quarter, to a total of $397 million. It's not clear whether the total amount reserved includes the $185 million criminal fine.
Novartis said the same U.S. investigators are also probing "potential off-label marketing" and payments to health-care providers involving five other Novartis drugs: Diovan, Exforge, Sandostatin, Tekturna and Zelnorm. "Novartis is unable to assess with reasonable certainty the outcome of the investigation related to these five products or the amounts, which could be material, that it might be required to pay to resolve this investigation," it said in its statement.
A number of drug companies, including Pfizer Inc. and Eli Lilly & Co., have reached large settlements in recent months with U.S. investigators over marketing practices. AstraZeneca in September reached a preliminary agreement to pay $520 million to settle a U.S. investigation into its marketing of the schizophrenia drug Seroquel, including allegations the company promoted the drug "off-label."
Write to Jeanne Whalen at jeanne.whalen@wsj.com
This is a "must read"! - Marketing Based Medicine
Abstract: While much excitement has been generated surrounding evidence-based medicine, internal documents from the pharmaceutical industry suggest that the publicly available evidence base may not accurately represent the underlying data regarding its products. The industry and its associated medical communication firms state that publications in the medical literature primarily serve marketing interests. Suppression and spinning of negative data and ghostwriting have emerged as tools to help manage medical journal publications to best suit product sales, while disease mongering and market segmentation of physicians are also used to efficiently maximize profits. We propose that while evidence-based medicine is a noble ideal, marketing-based medicine is the current reality.
AstraZeneca - Seroquel: the weight of evidence in the UK
The marketing team sued over a drug's alleged side effects tried to suppress key data, an ex-employee has claimed.
Seroquel's former UK medical adviser told the BBC he was pressured to approve promotional material which said weight gain was not an issue.
Maker AstraZeneca, which faces fresh legal action next month, said it took concerns about its conduct seriously.
In the same programme, the British Medical Journal editor urged that the medicine licensing system be reviewed.
Dr Fiona Godlee said industry should no longer provide the evaluations of its own drugs which the licensing body considered.More at BBC
File on 4 is on BBC Radio 4 on Tuesday, 26 January , at 2000 GMT, repeated Sunday, 31 January, at 1700 GMT. You can also listen via the BBC iPlayer after broadcast or download the podcast.
Kickbackers’ motto: ‘Do no harm’ (to profits) - The Boston Globe
TALK ABOUT death panels. The US attorney in Boston recently filed suit against the world’s largest maker of health products, Johnson & Johnson, for using kickbacks to get more nursing home patients onto its drugs, including one that was later found to be so lethal to the elderly it had to carry a black-box warning. The government’s complaint leaves little doubt that the drug company acted in a predatory way to increase sales and market share for its products, especially Risperdal, an antipsychotic often used to keep Alzheimer’s and dementia patients under control.
FDA Approves Novo-Nordisk's Diabetes Drug Victoza - ABC News
Victoza, belongs to the GLP-1 family of diabetes medications, which also includes Byetta, marketed by Eli Lilly & Co. and Amylin Pharmaceuticals Inc. Both drugs help control blood sugar by increasing insulin production, slowing the body's absorption of sugar.
Novo's drug would enjoy an advantage over Byetta because it requires one injection per day, instead of two.
The company said it expects Victoza, which has been approved in Japan and Europe, to be on the U.S. market within weeks.
Monday, January 25, 2010
Liu Bolin and JaeSelle - what's the connection?
Also she tweeted:
AD = Art DirectorMy how she's changed her view since Jan 19th!
When she first called the Seroquel ad "creative" we exchanged a few DM tweets:
I would not normally share DM's - but on this occasion the truth should come out!Isn't Social Media wonderful!
Bayer - Mirena IUD: beyond Tupperware!
Bayer Pharmaceuticals, the maker of the Mirena IUD, has teamed up with the Mommy marketing site “Mom Central” to sponsor house parties to sell women the Mirena IUD.
According to a warning letter sent to Bayer by the FDA about the worded content of the events -
The Mirena program is a live presentation designed for a consumer audience of “busy moms.” The program is presented in a consumer’s home or other private setting (e.g. private restaurant party) by a representative from Mom Central (a social networking internet site) and a nurse practitioner (Ms. Barb Dehn). The Mirena program submitted to FDA also references a presentation given by a fashion stylist (Ms. Angela Hastings) that immediately follows Ms. Dehn’s presentation regarding the use of Mirena. The script of Ms. Hastings’ presentation regarding fashion tips was not submitted to FDA.More at "The Blog That Ate Manhattan"
The UK's ABPI Code of Practice is a worthless joke!
Ferring Pharmaceuticals and Stiefel Laboratories have been named and shamed for breaching the ABPI Code of Practice.
Adverts giving details about the cases appeared in the BMJ, The Pharmaceutical Journal and The Nursing Standard in December.
Stiefel’s misdemeanour was to present the output of a company-run meeting as an independent supplement to a medical journal.
A GP and a pharmacist complained about the insert on the management of mild and moderate acne vulgaris using Duac Once Daily Gel (clindamicyn 1% and benzoyl peroxide 5%).
Consistent with recent cases regarding sponsored insets, this activity was deemed to contravene clause 2 of UK pharma’s Code of Practice, which deals with bringing discredit upon, and reducing confidence in, the industry.
Ferring, meanwhile, has breached several more clauses, according to the ABPI’s arms-length Code overseer the Prescription Medicines Code of Practice Authority (PMCPA).
The company voluntarily admitted that Ferring’s public relations agency sent unapproved copy about prescription-only medicine Firmagon (degarelix) to a patient organisation.
The agency edited Ferring’s approved information about the drug, which is indicated for the treatment of advanced prostate cancer, and the patient group used this to develop content on its own website.
The agency had left out a number of key elements from the original, including side effects, background data on prostate cancer and comments from a clinical urologist.
It also added the sentence “Ask your doctor for more information about FIRMAGON” and exaggerated the time taken by LHRH agonists to achieve castrate levels of testosterone.
As well as being found guilty of a clause 2 infringement, the PMCPA cited Ferring on four more counts.
These were: failing to maintain high standards (clause 9.1), failing to certify information provided to a patient organisation (clause 14.3) and encouraging members of the public to ask their health professional to prescribe a specific prescription-only medicine (clause 22.2).
The PMCPA said Ferring had also influenced the text of patient organisation material in a manner favourable to a company’s commercial interests (clause 23.6).Source
Insider's view: Ho hum! The companies must feel really chastened!
Sunday, January 24, 2010
NY Gov wants to ban gifts to doctors
New York Gov. David Paterson is proposing new, tougher prohibitions on pharmaceutical companies, restricting them from dispensing gifts and misleading production information to doctors while promoting the use of specific drugs. New York would join at least nine states that have enacted legislation affecting pharmaceutical marketing, according to the National Conference of State Legislatures.
"This will benefit patient care and reduce costs in the Medicaid program, as more expensive drugs will not be prescribed for the wrong reasons," Paterson said.
Paterson wants to prevent pharmaceutical companies from influencing the prescribing habits of doctors.
"Cracking down on the gifts that the drug industry gives to doctors could lead to more independent prescribing by physicians," said Bill Ferris, a lobbyist for AARP, an advocacy group for older Americans. "Doctors are constantly being solicited to prescribe high-cost brand name drugs when equally effective less expensive drugs may be available."More
AstraZeneca eyes fresh share buy-back scheme after stellar 2009 - Telegraph
By Graham Ruddick
Published: 10:48PM GMT 23 Jan 2010
The drug group's board, led by chief executive David Brennan, will hold a board meeting early this week to finalise a decision, with an announcement expected alongside the company's annual results on Thursday.
Saturday, January 23, 2010
Pharma Giles writes......
Phoni Pharmaceutical’s CEO Johnny B. Sinister today announced that his company “fully supported” the 10:23 campaign publicising the “pseudo-science” behind the increasingly popular healthcare fad of homeopathy.
The 10:23 campaign, organised by the UK’s Merseyside Sceptics, is intended to raise awareness about the “reality of homeopathy, how it can be proven not to work and why homeopaths' claims are impossible”.
“Homeopathy is an insult to the science of human healthcare and to the modern pharmaceutical industry as a whole,” said Mr. Sinister in a press conference earlier today.
“It is inflicting expensive products with no clinical benefits whatsoever on to a gullible and unsuspecting public, whilst at the same time making ludicrous and unsupportable claims for efficacy and safety,” he continued.
“Such quackery is leading to a dangerous situation where the public is being conned into taking completely ineffective medicines, instead of treatments with tried and trusted benefits. And what’s worse, we are now seeing a trend where those who speak out about this quackery are being silenced by threat of prosecution under the ludicrous UK libel laws.”
“Practitioners of homeopathy are either amateur scam artists or are hopelessly misguided,” Mr. Sinister said.
“The pushing of expensive, useless and possibly harmful products on the back of dodgy science should be left to professional pharmaceutical companies such as Phoni, and not to a bunch of johnny-come–lately amateurs like homeopaths,” he observed.
“We really don’t care for the idea of homeopaths muscling in on our market for quack medicines and then using legal scare tactics to frighten off critics”, said the Phoni CEO.
“That’s our job, and so we’re only too happy to support any campaign that looks to discredit the competition…”
Follow the links to the 10:23 campaign and the Merseyside Skeptics. Read about Simon Singh’s legal battle with the British Chiroquackers (sorry, Chiropracters) Association here.
Don’t forget to sign the petition to get homeopathic medicines subject the same scrutiny as real ones.
Read more about the increasing use of “libel tourism” as a means of silencing critics here.
And for an example of a healthcare company using libel tourism to suppress anyone who speaks out about their dangerous products, go here.
This is all scary stuff….
Lawrence M DuBuske MD quits Brigham to speak for pay - The Boston Globe
DuBuske is no ordinary speaker. Out of thousands of US doctors hired by drug-maker GlaxoSmithKline to talk about its products, he was the highest paid during a three-month period last year, the company recently disclosed: He made $99,375 for giving 40 talks to other physicians last April, May, and June, almost one every other day.
Friday, January 22, 2010
Wyeth - Prevnar: Whistleblower Mark Livingston's speech
Here is the speech he gave at a ceremony, at which he was given the Joe A. Callaway Award for Civic Courage.
Please take a moment and read it.
Thank you.
Introducing Michael M Durand's Blog
http://michaelmdurand.blogspot.com
Love this post:
I can’t resist highlighting some of the worst health care public ideas that have ever cross my ears. Some of these were included in proposals in which I had a hand, so I am not an innocent, snickering bystander. But some I vetoed before they were offered up to clients.
Thank God.
The point is that “creativity” is not an exercise in coming up with the most outlandish gimmick, but ideas that advance brand goals. As Benton & Bowles used to say, “if it doesn’t sell, it isn’t creative.”
Can you add to this list? Let me know.
Hummers for Heroes. A large pharmaceutical company wanted recommendations for its AIDS/HIV franchise. One tactical solution, “Hummers for Heroes” was to give away Hummers, those icons of 20th century excess, to AIDS clinical thought leaders. Just nice gifts for all their hard work. Oy. That one got nixed before the client got his eyes on it.
There's more
Thursday, January 21, 2010
Reductil (sibutramine) pulled from the EU market
The anti-obesity drug sibutramine has had its licence suspended by the European authorities due to concerns over an increased risk of cardiovascular events with the treatment.The Medicines and Healthcare products Regulatory Agency announced today that a European-wide review had concluded the risk of heart attacks and strokes from sibutramine (Reductil) outweighs the benefit gained from weight loss.
NHS data show GPs issued over 330,000 prescriptions for sibutramine in 2008, but GPs have been advised not to issue any new prescriptions for sibutramine and to review the treatment of any patients taking the drug.
Both the European Medicines Agency and the US Food and Drug Administration announced reviews into sibutramine last December after a study found an excess of serious cardiovascular events in high-risk patients on the treatment.
Dr June Raine, director of vigilance and risk management of medicines at the MHRA said: 'Evidence suggests that there is an increased risk of non-fatal heart attacks and strokes with this medicine that outweigh the benefits of weight loss, which is modest and may not be sustained in the long term after stopping treatment.
'Prescribers are advised not to issue any new prescriptions for Reductil and to review the treatment of patients taking the drug.
MeReC Extra Extra! Read all about it!
Hat tip: http://www.prescriber.org.uk/
Quote
Benjamin Franklin (1706-1790) American statesman, scientist and philosopher
This sounds interesting: File on 4, Tuesday, January 26th, 20:00 on BBC Radio 4
A British drug company is being sued by more than 15,000 people in the United States who claim its bestselling antipsychotic drug caused severe weight gain, diabetes and other serious medical conditions.Ann Alexander investigates concerns about the way it was marketed and asks how much the public should be told about the drugs they take.
File on 4 - Source
Hmmm! I wonder which antipsychotic that might be?
Swine flu is not just a hoax by big pharma - New Scientist
Posted via web from Jack's posterous
Hmm!
On January 25 the Parliamentary Assembly of the Council of Europe (PACE) will launch an emergency inquiry regarding the influence of pharmaceutical companies on the global swine flu campaign.
The inquiry will focus on the drug industry’s influence on the World Health Organization (WHO).
The motion was introduced by Dr. Wolfgang Wodarg, head of health at the Council of Europe, who has accused the makers of flu drugs and vaccines of influencing the World Health Organization's decision to declare a pandemic.
The motion has now been signed by 14 members from 10 countries sitting on the EU’s Health Committee, who are angry that nations all over the world, and particularly in Europe, have wasted scarce health funds on a contrived “pandemic.”
The investigation is listed on the EU’s draft agenda as “Request for Debate Under Urgent Procedure on ‘Faked Pandemics – A Threat for Health’.”
Wednesday, January 20, 2010
Forest - Savella: not worth the risk say Public Citizen
Public Citizen Petition to FDA: Dangerous Fibromyalgia Drug Should Be Pulled From the Market
Medication Has Limited Efficacy, Risky Effects
WASHINGTON, D.C. – The fibromyalgia drug Savella should immediately be taken off the market because its dangers outweigh its benefits, Public Citizen said today in a petition to the Food and Drug Administration (FDA). The European regulatory authority, the European Medicines Agency (EMEA), rejected the drug’s approval for fibromyalgia in July 2009, stating that its benefits were “marginal” and “did not outweigh its risks.” This was shortly after the FDA approved the drug in January 2009. Since the drug went on the market in the U.S., approximately 250,000 prescriptions have been filled, with doctors writing more prescriptions every month.
In two randomized clinical trials, Savella, also known by its generic name milnacipran, was found to increase blood pressure, heart rate and suicidal thoughts, Public Citizen’s petition said. Among patients who had normal blood pressure at the beginning of the study, 19.5 percent of those who took Savella developed hypertension, compared to 7.2 percent of those on a placebo.
“Because Savella is a drug that produces only a marginal effect on pain, the main problem for which patients seek treatment, and has the potential to be quite dangerous, it is clear that it should not be sold,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “The FDA never should have approved Savella for fibromyalgia and should now immediately order the drug company to remove it from the market before large numbers of people suffer serious harm,” Wolfe said.
Based on the extent of increased blood pressure caused by Savella, the FDA medical officer who reviewed the drug estimated that persistent blood pressure hikes could increase the risk of a cardiovascular event (including death, myocardial infarction and stroke) by up to 50 percent.
Savella also puts patients at risk for other disorders, including seizures, addiction, excessive bleeding, mood disorders, fractures, glaucoma and gastrointestinal effects such as nausea and vomiting. In pregnant women, the drug also can lead to hazards for fetuses, newborns and nursing infants. Additional risks for men include testicular pain and problems with ejaculation.
The director of the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products stated that although the dominant symptom of fibromyalgia is pain, the drug did not relieve patients’ pain in the clinical trials.
Fibromyalgia is a chronic disease, but neither of the drug’s trials showed any statistical effectiveness beyond three months. And even within the trials’ three-month duration, more than 90 percent of users in the trial received no benefit from the drug at all.
Although not marketed as an antidepressant in the U.S., Savella is sold in Europe and Japan as such. The drug is required in the U.S. to have the “black box” warning for antidepressants, which points out an increased risk of suicide in children, adolescents and young adults. Manufactured by Cypress Bioscience Inc. and Forest Laboratories Inc., Savella has been sold in the U.S. since May 2009.
READ the petition.Stent Wars continue
J&J, the world’s largest health products company, asked for an order barring Boston Scientific’s infringement and for unspecified damages, in a lawsuit filed Friday in federal court in Wilmington, Del. The Promus competes with J&J’s Cypher stent.
Boston Scientific’s “infringing sales have reduced Cordis’s Cypher stent sales and caused irreparable harm to Cordis,’’ J&J said in the lawsuit.
Boston Scientific said it will vigorously defend itself.
More
Tuesday, January 19, 2010
Love it! A mass homeopathy overdose planned
At 10:23am on January 30th, more than 300 homeopathy sceptics nationwide will be taking part in a mass homeopathic 'overdose'.
What is homeopathy?
Homeopathy is an unscientific and absurd pseudoscience, yet it persists today as an accepted complementary medicine.
Ask many people what they think homeopathy is, and you'll be told "it's herbal medicine" or "it's all-natural". Few realise that it's been proven not to work; even fewer know it involves substances so dilute that there's nothing left in them. Homeopathy takes advantage of this uncertainty to sit alongside real, proven medicines on the shelves of our major pharmacies.
The 10:23 Campaign
The 10:23 Campaign aims to raise awareness about the reality of homeopathy. We will tell you how it can be proven not to work, why homeopaths' claims are impossible, why you should care.
The campaign is organised by the Merseyside Skeptics Society, a non-profit organisation for the promotion of scientific skepticism. More information about Merseyside Skeptics is available on their website.
FAO Saatchi and Saatchi Healthcare and Chinese artist Liu Bolin
Dear oh dear! I think you two might need to get together to work this out!
I wonder if AstraZeneca know about this yet!
I wonder if Liu and The Daily Mail know about it?
http://twitter.com/jpbr/status/691871432
Thanks: http://twitter.com/JaeSelle
Roche - RoActemra: hoots mon!
The Scottish Medicines Consortium, which decides on the cost-effectiveness of medicines, said it had accepted the drug for restricted use within the National Health Service in Scotland.
By contrast, the National Institute for Health and Clinical Excellence (NICE) which assesses treatments in England and Wales, said last month it was minded not to recommend it, unless Roche proved more evidence of its value.
RoActemra is also known as tocilizumab and is sold in some markets as Actemra.Hat tip: Reuters' Ben Hirschler
H1N1 contd. - anyone want some vaccines going cheap?
Greece cancelled Monday a third of its swine flu vaccination orders and sought compensation for the advances it paid to the big companies that provide them, the health ministry said.
Meanwhile, Norway agreed a deal with British pharmaceutical giant GlaxoSmithKline (GSK) to reduce its number of vaccines by 30 percent according to its health ministry.
"We will pay only for the deliveries we have received", Greece's health minister said at a press conference, adding "the country demands the refund of the advance orders", from GSK, and two other pharmaceutical firms Novartis and Sanofis.
Sepracor/Eisai - Zebinix: Scots say nix
The Scottish Medicines Consortium (SMC) has issued its monthly advice on new medicines.
Eslicarbazepine acetate (Zebinix®) has been rejected for use as an adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation. The review notes that efficacy has been demonstrated in three 12-week placebo controlled trials but that no active comparator studies have been completed. The economic analysis in the submission was not sufficiently robust to gain acceptance.Hat tip: http://www.prescriber.org.uk/
Death of the Drug Rep contd.
In one of the largest industry restructurings in years, just about every one of the nation's major drug makers is shrinking its sales force. The move is a stark turnaround from years of bulking up their sales ranks and blitzing doctors' offices with samples, literature and free lunches.
Increasingly, doctors have gotten tired of the nonstop sales visits, which have cut into their time to see patients. These days, more than a third of medical schools require sales reps to have an appointment before calling on physicians or residents, according to the American Medical Association. About one in four physicians works in a practice that refuses to admit sales reps. Of those who do see reps, nearly half require an appointment, up about 23 percent from 2008.
"It just got out of hand, with the number of people calling on these doctors every week," said Linda Bannister, a drug analyst for Edward Jones in St. Louis. "It wasn't a good use of resources anymore for the drug companies."
Read more about how Lilly are cutting