Profits Before People: Merck and Schering-Plough Caught Red handed
April 1, 2008
Emails between a Schering-Plough executive and the principle investigator of the ENHANCE trial were made public today by Sen. Chuck Grassley. The emails reveal that the ENHANCE trial’s principal investigator perceived that the drugmakers were withholding unfavorable results about ezetimibe/simvastatin (Vytorin) for non-scientific reasons. (Surprise Surprise). Instead of releasing the bad data, Sen. Grassley noted, Merck/Schering-Plough went on a marketing blitz to increase Vytorin prescriptions.
Popularity: 69% [?]
Prescription Drug Sales Growth Slows To Lowest Rate Since 1961
March 15, 2008
Sales growth in the U.S. prescription drug market slowed to the lowest rate in 46 years in 2007 as more brand-name drugs lost their exclusivity to generics and new product approvals declined, according to a report issued Wednesday.Sales came to $286.5 billion in 2007, up 3.8 percent, IMS Health said in its annual U.S. Pharmaceutical Market Performance Review. The rate of growth was the lowest since 1961, when sales increased by 3.3 percent.
In contrast, prescription drug sales grew by 8 percent in 2006.
Growth moderated beginning in 2001, but picked up in 2006 with the start of the federally subsidized prescription drug program for seniors, Norwalk-based IMS Health said. However, growth slowed again last year.
The Medicare Part D program accounted for 19 percent of retail prescriptions at the end of last year, a modest increase over 2006 “and reflective of a maturing program,” IMS said in its report. It said 65 percent of Americans 65 and older are now enrolled in the program.
Learn More: AP/Houston Chronicle
Popularity: 52% [?]
Panel Calls For Leadership To Protect Children From Targeted Marketing, Canada
March 12, 2008
A panel of prominent, independently minded Canadians ranging from educators, Aboriginal, community and youth leaders, journalists, public policy researchers, academics and authors, today released a recommendation for a made in Canada plan to ensure that unhealthy food and beverages are not marketed to children. The panel based its decision on presentations by key Canadian and international experts on best available legal, scientific and social evidence on food marketing to children and its impact on obesity. The panel examined the evidence both for and against increased regulation on food marketing to Canadian children. “Access to our children is a privilege not a right, and as such should be subject to stringent regulation,” said Avi Lewis, conference panel moderator on the consensus statement. “We believe the status quo is unacceptable, and cannot continue. Complexity is not an excuse for inaction.”
The Panel is calling on the governments of
The consensus statement was delivered as part of the Policy Consensus Forum on Obesity and the Impact of Marketing on Children hosted by the Chronic Disease Prevention Alliance of Canada (CDPAC). The conference, funded by the Public Health Agency of Canada (PHAC), the Canadian Institutes of Health Research (CIHR) and the Government of British Columbia, was planned in response to the March 2007 release of the ‘Healthy Weights for Healthy Kids’ report by the Standing Committee on Health which stated that childhood obesity has become an ‘epidemic’ in Canada.
“There is significant debate as to whether or not marketing aimed at children requires additional restrictions and around the role that government and industry should be playing to restrict marketing,” said Paul Lapierre, CDPAC Steering Committee Chair. “Our goal is to protect the well-being of Canadian children and the statement announced today, along with the specific recommendations, will help us make an informed decision as to next steps around policy requirement and provide healthy options to children.”
The Chronic Disease Prevention Alliance of Canada (CDPAC) is a network of leading health and non-health organizations who share a common vision for an integrated system of research, surveillance, policies, and programs for maintaining health and preventing chronic disease in
CDPAC’s role is to advocate for systems change and to facilitate and support information and knowledge exchange by connecting researchers, practitioners and policy makers for improved chronic disease prevention in
Popularity: 38% [?]
Pfizer Pulls Doctor Ad for Lipitor
February 25, 2008
Pfizer said today that it was pulling the plug on advertising that features Robert Jarvik, M.D., promoting the benefit of atorvastatin (Lipitor).
The Pfizer decision was included in a letter to Reps. John D. Dingell (D-Mich.), chairman of the Committee on Energy and Commerce, and Bart Stupak (D-Mich.) chairman of the Subcommittee on Oversight and Investigations. Last month, Dingell and Stupak launched an investigation into the ads, which they said misrepresented Dr. Jarvik’s credentials.
Dr. Jarvik is the inventor of an artificial heart that bears his name. He received his M.D. at the University of Utah in 1976, but he never completed a residency and has never been licensed to practice medicine.
Popularity: 47% [?]
FDA to Permit Promotion of Off-Label Use
February 17, 2008
FDA draft guidelines issued today would permit the marketing of FDA-approved drugs and devices by the use of scientific reprints that discuss unapproved indications — currently a forbidden practice.
But before they even hit the Federal Register, the draft guidelines drew fire from Rep. Henry Waxman (D-Calif.). He accused the FDA of proposing to “allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns.” (See: Waxman Says FDA Plans to Ease Restrictions on Off-Label Marketing)
Randall Lutter, Ph.D., the FDA deputy commissioner for policy, said in a statement that articles that discussed unapproved uses “can contribute to the practice of medicine and may even constitute a medically recognized standard of care.”
If finally approved, the new guidelines would supplant Section 401 of the FDA Modernization Act, which allows dissemination of the reprints as long as they are not used to promote off-label use.
Popularity: 54% [?]
ALERT - PROTECT YOUR HEALTH
February 16, 2008
The FDA is considering a policy change that would allow pharmaceutical companies to give physicians journal articles that detail off-label uses of drugs, according to Rep. Henry Waxman (D-Calif).
If approved, the FDA proposal “would allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he said.
Waxman has posted a copy of an FDA draft document that web site, along with his letter to FDA Commissioner Andrew C. von Eschenbach, M.D., protesting the proposed change.
Moreover, Waxman said, the House Committee on Oversight and Government Reform, which he chairs, will “be examining the draft guidance and the process that led to [its] development.”
Popularity: 51% [?]
Merck Agrees to Pay $671M to Settle Rebate Accusations
February 11, 2008
In one of the biggest U.S. health care fraud settlements ever, Merck & Co. will pay $671 million to settle claims it overcharged the government for four popular drugs and bribed doctors to prescribe its drugs, federal prosecutors said Thursday.
The alleged overcharges, dating back to the mid-1990s, involved Medicaid programs in the District of Columbia and every state but Arizona, as well as federal health-insurance programs at agencies including the Department of Defense and Veterans Administration.
A nationwide investigation by federal prosecutors, triggered in 2000 by a former Merck salesman-turned-whistleblower and broadened by a Louisiana doctor who also exposed overcharging, resulted in two settlements announced Thursday.
In Philadelphia, prosecutors said Merck agreed to pay $399 million for improper calculation of Medicaid rebates and bribing doctors. In New Orleans, prosecutors said the drugmaker agreed to pay $250 million for its rebate practices. With interest, that totals $671 million.
“Not only is the combined recovery in these two cases one of the largest health care fraud settlements ever achieved by the Justice Department, it reflects our continuing efforts to hold drug companies accountable for devising pricing schemes” that overcharge the government, said Attorney General Michael D. Mukasey.
Popularity: 49% [?]
Drug Ads Raise Questions for Heart Pioneer
February 7, 2008
Dr. Robert Jarvik is best known for the artificial heart he pioneered more than a quarter-century ago. Since then he had toiled in relative obscurity — until he began appearing in television ads two years ago for the Pfizer cholesterol drug Lipitor.
The ads have depicted him, among other outdoorsy pursuits, rowing a one-man racing shell swiftly across a mountain lake. “When diet and exercise aren’t enough, adding Lipitor significantly lowers cholesterol,” Dr. Jarvik says in the ad.
Celebrity advertising endorsements are nothing new, of course. But the Lipitor campaign is a rare instance of a well-known doctor’s endorsing a drug in advertising — and it has helped rekindle a smoldering debate over whether it is appropriate to aim ads for prescription drugs directly at consumers.
Popularity: 53% [?]
New Marketing Opportunity for Big Pharma
February 5, 2008
Our government and big pharma = perfect together.
The government has published guidance promoting partnerships between the National Health Service and the pharmaceutical industry, in a new tactic to improve patient care and help the service meet the rapidly changing demands of the 21st century.
Given its extensive knowledge on illnesses and innovative medicines, the industry certainly has a lot to offer the health service in terms of helping to boost patient care, and the government is hoping that the NHS will tap into this rich source of expertise to put in place a variety of locally tailored healthcare initiatives.
Popularity: 42% [?]
Nurses Are “Soft Targets” For Drug Companies’ Promotional Tactics
February 5, 2008
Nursing education fails to prepare graduates to deal with the pharmaceutical industry’s promotional tactics, and many nurses appear to accept promotional materials uncritically, according to an analysis of the nursing literature published in PLoS Medicine.
“The pharmaceutical industry recognizes nursing influence on medical prescribing and identifies nurses as a marketing target,” say the authors, Annemarie Jutel (Otago Polytechnic, Dunedin, New Zealand) and David Menkes (University of Auckland, Hamilton, New Zealand). “The industry has had its eye on nurses and nurse practitioners for over a decade, and is heavily invested in wooing them.”
Learn More: Medical News Today
Popularity: 51% [?]
Federal Grand Jury Probes Merck’s Handling of Vioxx
February 4, 2008
Merck & Co. is the subject of a federal grand-jury probe into its sales and marketing practices for Vioxx, the painkiller it pulled from the market in 2004, according to a person familiar with the matter.
The health-care-fraud unit of the U.S. Attorney’s Office for the District of Massachusetts is investigating whether Merck promoted Vioxx to health-care professionals for uses other than those approved by government regulators, a practice known as off-label marketing, this person said.
Learn More: Wall Street Journal
Popularity: 54% [?]
A judge has ruled that a Maine law barring prescribing information from being used for marketing is unconstitutional
January 7, 2008
Drug Topics Daily News
A law was supposed to go into effect in Maine on Jan. 1, prohibiting the use of physician prescribing information for marketing purposes. But a judge has issued a preliminary injunction barring the law from being implemented on the grounds that it is unconstitutional.
Learn More: Drug Topics Daily News
Popularity: 40% [?]
Drug Industry Spends Nearly Twice As Much On Marketing Than On Research And Development
January 4, 2008
The pharmaceutical industry spends almost twice as much on the marketing and promotion of drugs than on research and development, according to a new analysis in this week’s PLoS Medicine.
In their analysis of data from two market research companies, IMS and CAM, Marc-André Gagnon and Joel Lexchin (York University, Toronto, Canada) found that US drug companies spent US$57.5 billion on promotional activities in 2004, the latest year for which figures were available.
In comparison, the National Science Foundation reported that in 2004 the amount of industrial pharmaceutical research and development (including public funds for industrial research and development) was US$31.5 billion in the United States.
Popularity: 36% [?]
Detailing 101
November 30, 2007
There is a lot of discussion lately about the influence of pharmaceutical representatives on the prescribing habits of doctors. To fully understand what the issue is it is important to understand the process of detailing.
Usually very attractive pharmaceutical representatives visit doctors to “inform” them about the company’s product. This is called detailing. Detailing can include presentations from other doctors, free lunches, or dinners, etc. Detailing revolves around a “core message” which are sound bites regarding the drug’s safety and/or efficacy.
A pharmaceutical representative does not detail blindly. She or he is armed with data about doctors and answers to common questions. Pharmaceutical representatives are able to target “key” doctors by looking at the amount of prescriptions a doctor writes and his/her specialization. Doctors that write a lot of prescriptions are highly sought after and are usually “flagged” for followup using aggressive sales tactics. Pharmaceutical companies get doctor’s prescribing information from companies who buy the information from pharmacies. Pharmacies usually do not give out doctor’s names, but will give out something that is called a drug enforcement number. The American Medical Association sells the companies the names associated with the drug enforcement number. Amazing right?
Pharmaceutical representatives are also armed with answers to common questions. These are questions that a doctor would likely ask a representative about the drug they are selling or a competitor drug. The answers always transition back to the drug’s “core message”. If the doctor’s question gets too scientific the representative will refer the question to the home office. A “medical affairs” department will respond with a scientific answer, usually by another doctor, that downplays the concerns of the doctor and transitions the topic back to the core message.
That is detailing in a nutshell.
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Pharmaceutical Company Influence on our Teaching Centers
October 18, 2007
About 60% of department heads at medical schools and teaching hospitals in the U.S. have personal financial relationships with pharmaceutical or medical device companies, according to a study published on Wednesday in the Journal of the American Medical Association. Researchers sent a survey to department heads at all 125 accredited medical schools and the 15 largest teaching hospitals in the U.S. About two-thirds of department heads responded to the survey.
Popularity: 53% [?]
State Controls Pharmaceutical Influence
October 18, 2007
Click here to read the entire New York Times article
Two years after Minnesota officials forbade drug makers to give doctors more than $50 worth of food or other gifts per year, drug company sales representatives there are having a far harder time marketing to doctors. The rule change was small and almost accidental — a state official decided to interpret a 1993 law differently from his predecessor. But the effect on drug makers has been profound.
The year after the change, the number of visits that Minnesota primary care doctors accepted from drug sales representatives decreased at about twice the rate of the decline reported by primary care doctors nationwide, according to a survey by ImpactRx, a New Jersey firm that tracks pharmaceutical marketing. A growing number of Minnesota hospitals and clinics have banned routine visits from them.
Popularity: 33% [?]
March of the Clones
September 17, 2007
For those of you who don’t know, when a drug is approved by the Federal Food and Drug Administration (FDA) it receives an indication which specifies its use. In order to maximize the profitability of their drugs, pharmaceutical companies initiate new clinical trials or sponsor research to search for additional indications and, if the data are favorable, they will file with the FDA for a new indication.
What is at issue here is not the new clinical trials or the new indications, but promotion of a new indication of a drug without proper approval by the FDA (off label promotion). This is a common tactic used by pharmaceutical companies. Companies employ teams of very attractive females and males (clones) to encourage physicians to write more scripts for the drug they are selling. Doctors that are targeted according to their practice area and could be visited by these clones several times a day. The clones are armed with a multitude of selling devices, such as money for lunch and, if available, copies of studies showing new uses for their drug. The clone then mentions the suggested new use with the hopes that the doctor will prescribe more of the drug. This is highly improper and endangers public health. Just to be fair, however, not all pharmaceutical companies engage in this activity.
The costs are high when companies get caught engaging in this activity. For example, Neurontin was originally indicated for diabetic neuropathy. Teams of medical liaisons, i.e. clones with advanced degrees, traveled to doctor’s offices to show them studies opening up new uses for Neurontin (sometimes these liaisons promoted new uses without studies). Their tactic worked as doctors began to prescribe Neurontin for all sorts of off label uses, including depression, bipolar disorder, and epilepsy. The joy was short lived, however, as Neurontin’s manufacturer Warner-Lambert was hit with extensive criminal and civil charges and eventually agreed to pay $250 million criminal fine, $83.6 million to the Federal government, and $38 million to consumers [see Drug Maker to Pay $430 Million in Fines, Civil Damages]. This example shows you that the risks are high but so is the return. A company can open itself up to 100s of new customers by promoting off label use.
So here we go again, Cephalon is the manufacturer of two extremely potent pain medications that are both indicated for acute cancer pain, the Fentora lozenge and Actiq lollipop. Cephalon is currently under congressional investigation of its marketing practices of its Fentora and Actiq product [see House Lawmaker Seeks Data From Makers of Stents and Drugs]. There have been reported four deaths recently attributed to the Fentora lozenge [see Cephalon's Fentora linked to four deaths; labeling revisions under discussion, spokesperson says] and Actiq has been noted to be prescribed for off label uses.
When is this going to stop? Never. As long as there is huge profit margin and an overworked and understaffed governmental agency, pharmaceutical companies will take advantage of the situation and the clones will continue to march to the cries of the consumer.
Popularity: 54% [?]
