How Drugs Are Pitched
How Doctors Helped Drive the Addiction Crisis
THERE has been an alarming and steady increase in the mortality rate of middle-aged white Americans since 1999, according to a study published last week. This increase — half a percent annually — contrasts starkly with decreasing death rates in all other age and ethnic groups and with middle-aged people in other developed countries.
So what is killing middle-aged white Americans? Much of the excess death is attributable to suicide and drug and alcohol poisonings. Opioid painkillers like OxyContin prescribed by physicians contribute significantly to these drug overdoses.
Thus, it seems that an opioid overdose epidemic is at the heart of this rise in white middle-age mortality. The rate of death from prescription opioids in the United States increased more than fourfold between 1999 and 2010, dwarfing the combined mortality from heroin and cocaine. In 2013 alone, opioids were involved in 37 percent of all fatal drug overdoses.
Driving this opioid epidemic, in large part, is a disturbing change in the attitude within the medical profession about the use of these drugs to treat pain. Traditionally, opioid analgesics were largely used to treat pain stemming from terminal diseases like cancer, or for short-term uses, such as recovering from surgery.
But starting in the 1990s, there has been a vast expansion in the long-term use of opioid painkillers to treat chronic nonmalignant medical conditions, like low-back pain, sciatica and various musculoskeletal problems. To no small degree, this change in clinical practice was encouraged through aggressive marketing by drug companies that made new and powerful opioids, like OxyContin, an extended-release form of oxycodone that was approved for use in 1995.
The pitch to doctors seemed sensible and seductive: Be proactive with pain and treat it aggressively. After all, doctors have frequently been accused of being insensitive to pain or undertreating it. Here was the corrective, and who in their right mind would argue that physicians shouldn’t try to relieve pain whenever possible?
Well, doctors clearly got the message: The medical use of these drugs grew tenfold in just 20 years. Nearly half of all prescriptions by pain specialists are for opioids. But strikingly, primary care physicians, who generally do not have any particular expertise or training in pain management, prescribed far more opioids overall than pain specialists. For example, in 2012, 18 percent of all prescriptions for opioid analgesics were written by family practitioners, and 15 percent by internists, compared to 5 percent for pain specialists. (This partly reflects the fact that there are fewer pain specialists than primary care doctors.)
The consequences of this epidemic have been staggering. Opioids are reported in 39 percent of all emergency room visits for nonmedical drug use. They are highly addictive and can produce significant depressive and anxiety states. And the annual direct health care costs of opioid users has been estimated to be more than eight times that of nonusers.
But most surprising — and disturbing — of all is that there is actually very weak evidence that opioids are safe or effective for the long-term treatment of nonmalignant pain. So how did they become so popular for these uses? A large review article conducted between 1983 and 2012 found that only 25 of these were randomized controlled trials and only one study lasted three months or longer. The review concluded that there was little good evidence to support the safety or efficacy of long-term opioid therapy for nonmalignant pain. (In contrast, there is little question that opioid analgesics are highly effective for the relief of short-term pain.)
Furthermore, a large 2006 Danish study of a nationally representative sample of 10,066 people that compared opioid and nonopioid users found that opioid use was significantly associated with the reporting of severe pain, poor health, unemployment, and greater use of the health care system. It appears that long-term opioid use did not significantly relieve pain or improve quality of life in this well-designed study.Worse, there is a well-known syndrome of opioid-induced hyperalgesia in which opioids, paradoxically, can actually increase a person’s sensitivity to painful stimuli.
What the public — and physicians — should know is that there is strong evidence that nonsteroidal anti-inflammatory drugs (Nsaids), like Motrin, and other analgesics like Tylenol are actually safer and more effective for many painful conditions than opioid painkillers.
For example, one study found that a combination of Motrin and Tylenol had a much lower so-called number needed to treat than opioids. (The number needed to treat represents the number of people who must be treated for one person to benefit.) A lower number indicates a more effective treatment.
So how should we deal with the national crisis of opioid misuse, addiction and overdose? The Food and Drug Administration has already taken some tiny, though inadequate, steps forward in recent years by issuing a Risk Evaluation and Mitigation Strategy in 2012 that requires the makers of opioids to provide doctors with training and education about using them safely, and adding warnings to drug labels.
WHAT is really needed is a sea change within the medical profession itself. We should be educating and training our medical students and residents about the risks and limited benefits of opioids in treating pain. All medical professional organizations should back mandated education about safe opioid treatment as a prerequisite for licensure and prescribing. At present, the American Academy of Family Physicians opposes such a measure because it could limit patient access to pain treatment with opioids, which I think is misguided. Don’t we want family doctors, who are significant prescribers of opioids, to learn about their limitations and dangers?
It is physicians who, in large part, unleashed the current opioid epidemic with their promiscuous use of these drugs; we have a large responsibility to end it.
Richard A. Friedman is a professor of clinical psychiatry and the director of the psychopharmacology clinic at the Weill Cornell Medical College, and a contributing opinion writer.
Source : NY Times (Nov 2015)
Pharmacists paid by drug company for patient details
ONE of the world's biggest drug companies has been accused of paying Australian pharmacists to promote some of its best-selling drugs, in a controversial deal that has divided the profession. Pfizer pays pharmacies a $7 ''administration fee'' for each patient signed up to so-called support programs that involve the drug
company providing information directly to patients about nine of its drugs.
Pharmacists say the deal, which Pfizer struck with the Pharmacy Guild of Australia in July, is similar to the one dumped this month for them to market dietary supplements with prescription medicines.
The pharmacists' union said it was another example of the owners' guild using the good name of pharmacists to boost its profits. The union called on the guild to abandon the deal.
The chief executive of the Association of Professional Engineers, Scientists and Managers, Australia, Chris Walton, said: ''Just like the failed Blackmores deal, this uses a computer system to try to bypass the advice from a professional pharmacist. ''Instead of delivering better patient outcomes, this just aims to stuff more money into the pharmacy guild.
'' Pfizer receives patient information, including mobile phone numbers and email addresses, as part of the scheme, under which it provides regular information to patients about their condition and medication.
Like the Blackmores deal, when one of nine Pfizer drugs is being dispensed, the guild's computer system prompts pharmacists that patients are eligible for a support program.
One of the drugs included in the scheme is Pfizer's cholesterol-lowering blockbuster Lipitor, for which more than 10 million prescriptions were filled last year through the Pharmaceutical Benefits Scheme at a cost to the taxpayer of almost $600 million.
Pfizer will face competition from cheaper generic versions of the drug when its patent expires early next year.
Patients who sign up for the 12-week support program linked to Lipitor receive a cookbook and weekly emails
containing health advice. Other Pfizer drugs with associated support programs are Champix, Xalatan, Viagra, Lyrica, Pristiq, Aricept, Celebrex and Effexor XR.
A pharmacist who did not wish to be named said: ''Pharmacists might get a short-term gain of $7 but they are putting patient information into the hands of a drug manufacturer who is obviously going to promote their products directly to that patient.
''It's a back-door way of promoting and advertising.''
The pharmacist said the Pfizer deal was similar to that struck with Blackmores, which he said had done enormous damage to the reputation of pharmacists.
''In my mind now, if I want to recommend a product, I wonder if the consumer is thinking that I am just giving them the product to make money,'' he said.
'The guild often speaks as the voice of pharmacy but it's becoming pretty clear that they are just out for commercial ventures and not the interests of patients.''
A spokesman for the pharmacy guild said patients needed to provide written consent before being enrolled in the support programs and were made aware that their information would be provided to Pfizer.
He said the guild was ''confident of the completely ethical nature'' of the programs. A Pfizer spokeswoman said the programs were designed to benefit patients rather than achieve commercial objectives.
''Under no circumstances does Pfizer market its medicines directly to patients,'' she said.
Source : Brisbane Times
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A Fight Over How Drugs Are Pitched
By NATASHA SINGER
Before pharmaceutical company marketers call on a doctor, they do their homework. These salespeople typically pore over electronic profiles bought from data brokers, dossiers that detail the brands and amounts of drugs a particular doctor has prescribed. It is a marketing practice that some health care professionals have come to hate.
“It’s very powerful data and it’s easy to understand why drug companies want it,” said Dr. Norman S. Ward, a family physician in Burlington, Vt. “If they know the prescribing patterns of physicians, it could be very powerful information in trying to sway their behavior — like, why are you prescribing a lot of my competitor’s drug and not mine?”
Marketing to doctors using prescription records bearing their names is an increasingly contentious practice, with three states, Maine, New Hampshire and Vermont, in the vanguard of enacting laws to limit the uses of a doctor’s prescription records for marketing.
On Tuesday, the Supreme Court will hear arguments in a case, Sorrell v. IMS Health, that tests whether Vermont’s prescription confidentiality law violates the free speech protections of the First Amendment.
The case is being closely watched not only by drug makers and data collection firms, but also by health regulators, doctors and consumer advocates who say the decision will have profound implications for doctors’ control over their prescription histories, and for information privacy, medical decision-making and health care costs.
Vermont’s attorney general, William H. Sorrell, petitioned the court to review the case after three leading data collection firms including IMS Health, a health information company, and the Pharmaceutical Research and Manufacturers of America, a drug industry trade group, challenged the state statute. Although the federal district court in Vermont originally upheld the law, an appellate court reversed the decision last November.
The federal government, the attorneys general of several dozen states, AARP, professional medical associations, privacy groups and the New England Journal of Medicine have filed briefs in support of Vermont’s law. The National Association of Chain Drugstores, the Association of National Advertisers and news organizations like Bloomberg and The Associated Press have filed briefs aligning themselves with the data firms.
The concern over marketing based on doctor-specific prescription records revolves around the argument that it makes commercial use of private health treatment decisions — initiated in nonpublic consultations between doctor and patient, and completed in government-regulated transactions with pharmacists.
The data has become more available because pharmacies, which are required by law to collect and maintain detailed files about each prescription filled, can sell records containing a doctor’s name and address, along with the amount of the drug prescribed, to data brokers. (The records are shorn of patient names and certain other personal details covered by the Health Insurance Portability and Accountability Act, known as H.I.P.A.A., the federal legislation governing a patient’s privacy.) Data brokers in turn aggregate the records for use in medical research and marketing.
Drug makers spent about $6.3 billion on marketing visits to doctors in 2009, the last year that such figures were available, according to IMS Health. Access to a doctor’s prescription history, drug makers say, helps ensure that information about the latest prescription drug options quickly reaches specialists who treat particular conditions.
But some federal regulators and medical societies argue that drug makers are simply mining the data to identify and go after the doctors who would be most likely to prescribe the latest, most expensive brand-name medicines — driving up health care costs and exposing patients to newer drugs whose side effects may not yet be fully known.
Vermont enacted its prescription confidentiality law with the idea that drug makers do not have an inherent right to a doctor’s identifiable prescription information for use in marketing because the data originated in highly government-regulated, nonpublic health care transactions, said Mr. Sorrell, the Vermont attorney general.
“Does ‘Ajax Incorporated’ have a constitutional unfettered right to the data for commercial purposes,” Mr. Sorrell said, “or is it legitimate to give the doctor who is writing the prescription a say over whether that information should be used for marketing?”
Although the state law does not inhibit pharmaceutical sales representatives from marketing to doctors in their offices, he said, it does give doctors the right to consent before their prescribing information may be sold and used for marketing. If a doctor does not agree, he said, pharmacies must remove or encrypt the doctor’s name, just as they do for patients, before they sell this type of record for promotional use.
Even if the Supreme Court were to find that the law infringes on free speech, Mr. Sorrell added, the justices could still uphold the law on the grounds that the state has a legitimate interest in containing the higher medical costs and safety risks that can be associated with the newest drugs.
But industry representatives contend that Vermont should not be allowed to cherry-pick certain approved uses for the records in question while restricting those that conflict with what the law’s opponents say is the state’s apparent agenda: promoting less expensive generic drugs in an effort to lower health care costs.
Vermont allows those records to be used in research and by law enforcement, said Thomas C. Goldstein, a lawyer representing IMS Health. Moreover, he said, drug makers are allowed to buy the very same records so they can identify doctors whose patients might be good candidates for clinical trials or communicate drug safety updates.
“The one exception is that drug companies cannot use the data to combat the insurers’ and the state’s messages about their products,” Mr. Goldstein argued.
He added that pharmacies obtain the information through business transactions that are no different than any other, making the physician records no more private than stock quotes or commodity prices.
“It’s all data,” he said, “and it’s all protected by the First Amendment.”
Moreover, such laws reduce the ability of drug makers to quickly communicate with specialists about new drugs for rare diseases, a situation that could make it prohibitive for, say, a small biotechnology company with a tiny sales force to market a breakthrough medication, said Randy Frankel, the vice president for external affairs at IMS Health.
“Without the data, you might visit 1,000 physicians to identify the 10 whose patients might most benefit,” Mr. Frankel said. “With the data, you would go to the 10.”
But some consumer advocates say the real issue in the case is the confidentiality of information that people submit in government-regulated transactions that they would not otherwise make public.
“If the court is not going to protect personal and confidential health records,” said Wells Wilkinson, a staff lawyer at Community Catalyst, a nonprofit group that filed a brief in support of Vermont, “how could any consumer transaction be protected?”
Source : The New York Times
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