by Dr.Harald Wiesendanger– Klartext
What the mainstream media is hiding
Many doctors allow themselves to be used by pharmaceutical companies in “application observations”: scientifically worthless studies without a control group. Nevertheless, such pseudo-studies are extremely useful, at least for the client: They create welcome opportunities to introduce the doctor and his patients to a new drug. Critics speak of legalized corruption.
Every tenth resident doctor, along with thousands of clinicians, takes part in so-called “application observations” (AWB), also known as “non-interventional studies”: scientifically worthless studies without a control group, mainly without a test plan and a predetermined goal – be it before the market launch of a drug, as so-called “seeding trials” (from English to seed: sowing), either after approval has been granted. There is no obligation to publish.
At least 1,300 such pseudo-studies took place in Germany between 2009 and 2014 – that’s how many “researching” pharmaceutical companies reported to the National Association of Statutory Health Insurance Physicians (KBV). Around the turn of the millennium, there were 400 per year; in 2005, it was already around 700. (1) 17,000 doctors pocketed the money for controversial studies in 2014.
Doctors are given a good supply of a new drug with the intention of trying it out on their patients and “observing” how it works. All you have to do is fill out a few forms and ask the patient how they can get the drug. The bribes disguised as a “fee” that flow here range from 25 to 600 euros per patient (2) but can also be in four figures (3), up to an almost obscene 7000 euros.
Hidden corruption
That’s tempting: a panel doctor earns less than 200 euros per quarter for a cancer patient. However, if he prescribes the cancer drug Avastin as part of an AWB, the manufacturer Roche rewards a single hastily filled-out form with up to 1260 euros.
Numerous corporations put in a tremendous amount of effort: In 2005, for example, AstraZeneca started an observational study for the proton pump inhibitor esomeprazole with no fewer than 17,000 doctors; Altana had the competing drug Pantoprazole “observed” by 6,000 doctors. AWBs, each with several thousand doctors, were also dedicated to lipid-lowering drugs (ezetimibe, simvastatin) and drugs to treat high blood pressure (irbesartan), urinary incontinence (duloxetine) and neurodermatitis (pimecrolimus). (4)
In 2014 alone, pharmaceutical companies distributed more than EUR 100 million to almost 20,000 German doctors who worked in AWBs.
“Application observations” are camouflaged marketing campaigns, often for drugs that are many times more expensive than others of equal value: Doctors and patients are to be made familiar with the drug and tempted to prescribe it. (5) Critics such as the chairman of the drug commission of the German medical profession, Wolf-Dieter Ludwig, therefore advocate a ban.
Laughable search for knowledge
The pharmaceutical companies naturally reject the accusation of “legalized corruption,” which Transparency International has been raising for a long time: With AWBs, they hypocritically assure, the sole purpose is to “generate further findings on effectiveness and safety under practical conditions.” (6) That’s ridiculous: Doctors are already obliged to report side effects to the Medicines Commission or the Federal Institute for Drugs and Medical Devices (BfArM) – without receiving any money for it. Occasionally, “application observations” are aimed at drugs that have been on the market for decades; What other new “findings” regarding their effectiveness could we expect? In April 2015, Pfizer launched an AWB for its rheumatism drug Enbrel – 15 years after its approval and shortly before the first competing drugs came onto the market. Doctors who took part waved 650 euros – mind you, per patient.
And did the manufacturer of Klosterfrau Melissengeist have to pay German doctors 225 euros per “observed” patient to test whether the product had a calming effect – as has been known for around 190 years? (7)
“From a scientific point of view, the money is wasted,” says Jürgen Windeler, head of the Institute for Quality and Efficiency in Health Care (IQWIG).
Of course, it makes sense to check the benefits and harmlessness of drugs after they have been launched through long-term observations. However, there are PASS or PAES studies for this. (The abbreviations stand for “Post Authorization Safety” and “Post Authorization Efficacy.”) Health authorities such as the BfArM can officially order them if they see a need for an investigation because a new drug’s safety and/or effectiveness are not sufficiently proven. (8) (As an aside, when isn’t that the case?) Recently, such investigations have been carried out, for example, into “modern” birth control pills, cancer drugs, or drugs to treat multiple sclerosis. AWBs from pharmaceutical companies do not come anywhere near the level of such studies.
Therapeutically dubious, morally questionable
Nobody envies doctors an extra income. Rather, “application observations” become therapeutically dubious and morally questionable because they tempt a patient not to prescribe the most effective, most tolerable, and cheapest of several possible preparations, but rather the one that is most lucrative for the prescription issuer and the manufacturer. What about the ethics of ethics committees that tolerate and approve this activity?
Anyone who thinks that no pharmaceutical company can afford the horrendous sums that would be necessary to bribe well-paid doctors is wrong. Up to 90 percent of the US pharmaceutical industry’s marketing budget is aimed at physicians. (9) And so “advising” specialists can collect remuneration between 4,000 and 60,000 euros. (10) Some clinicians collect up to 90,000 euros “consulting fee” if they are invited to a conference of the pharmaceutical industry (11), and in individual cases, 400,000 dollars for eight days of consulting work. (12) Four of the largest manufacturers of hip and knee implants paid out more than $800 million between 2002 and 2006 to physicians who had signed “consultant” contracts with them. (13)
That pays off because baited doctors are far better product promoters than pharmaceutical representatives. For example, internal calculations at pharmaceutical giant Merck revealed that for every dollar it puts into doctor’s speaking fees, it got $3.66 back. (14)
Whose bread I eat…
If such investments didn’t pay off – what’s the point of them at all? According to a study that included data from nearly 7,000 physicians, participants in an AWB prescribed the corresponding drug 8 percent more often. Even one year after the end of an AWB, the prescriptions were still seven percent higher than in the comparison group.
Doctors’ willingness to prescribe a drug for cases it’s not approved for – “off-label use” – increases by 70 percent after the manufacturer invites them to a meal to discuss illegal uses. (15) Even the quality of the menu affects the prescription rate. (16) Whose bread I eat, whose song I sing.
Money does not always have to flow before doctors can be put on a leash. When recruiting for “application observations,” for example, pharmaceutical representatives like to emphasize that the doctor in question was “chosen to take part in this test phase because of his outstanding work,” as a former pharmaceutical manager chatted out of the box. “We would carefully evaluate the results they achieve with their patients and, of course, give significant credit to the participating doctor’s name in the study. That alone is enough of an incentive for many to take part. Seeing your own name printed in a study is tempting for a doctor who, in the routine of everyday life, doesn’t notice the fresh wind of empirical science. Be a researcher for once! And then be named in a publication! The official confirmation: The man is more than just a Sickbed shifter!” Such prospects “caress the ego.” (17)
Hardly any of the 71,000 doctors in Germany who admitted to having collected money from the pharmaceutical industry in 2015 (18) freely admit that such conveniences could ever cloud their judgment, influence their advice for patients, and affect their prescribing behavior. Actually? In 2015, just for traveling for training purposes, a German urologist and senior physician received pharmaceutical donations of 25,357 euros, a neurologist from Essen received 134,078 euros for “consultation and services” and a further 60,820 euros as “reimbursement of expenses”. (19) And such sums are supposed to have no psychological effects, at least in the minds of medical professionals?
Example Rosiglitazon – trade name “Avandia” -a diabetes drug. In 2007, a meta-analysis of 42 studies found that it increased the risk of heart attacks by 43 percent. (20) Despite this, numerous physicians continued to prescribe it because they considered the risk to be acceptable. According to a 2010 study, precisely these physicians were frequently considered for payments by the rosiglitazone manufacturer. (21) Whose bread I eat…
(Harald Wiesendanger)
Remarks
More in Harald Wiesendanger: The health care system – how we see through it, survive and transform it, chap. 6: „Dressierte Halbgötter“ und Kap. 7 „Nimmersatte Mietmäuler“.
1 Arznei-Telegramm 37/2006, S. 93-94: „Kurz und bündig“
2 ebda.
3 Peter Gøtzsche: Tödliche Medizin und organisierte Kriminalität – Wie die Pharmaindustrie das Gesundheitswesen korrumpiert, München 2. Aufl. 2015, S. 131.
4 Arznei-Telegramm 37/2006, s. 93-94.
5 Gøtzsche: Tödliche Medizin …, a.a.O., S. 130 ff.
6 Zahlenangaben und Zitat Roche nach Süddeutsche Zeitung Nr. 58, a.a.O.
7 Nico Damm: „Heilung um jeden Preis?“
8 Nach § 4 Abs. 34 und § 28 Abs, 3 a und b des Arzneimittelgesetzes.
9 T. A. Brennan u.a.: “Health Industry Practices That Create Conflicts of Interest, “Journal of the American Medical Association 295/2006, S. 429-433.
10 S. Boseley: “Junket time in Munich for the medical profession – and it’s all on the drug firms, “The Guardian 5.10.2004.
11 J. Moore, “Medical device payments to doctors draw scrutiny, “Star Tribune 8.9.2008.
12 R. Abelson: “Whistle-blower suit says device maker generously rewards doctors, “New York Times 24.1.2006.
13 J. Lenzer: “Doctor’s group files legal charges against nine French doctors over competing interests, “British Medical Journal 338/2009, S. 1408.
14 “Can I buy you a dinner? Pharmaceutical companies increasingly use doctors’ talks as sales pitches “, August 2004; www.worstpills.org.
15 Das belegt eine interne Aktennotiz des Neurontin-Herstellers, s. G. Harris: „Pfizer to pay $ 430 million over promoting drug to doctors“, New York Times 14.5.2004.
16 Nach Kim Björn Becker: „Wes Brot ich ess …“, Süddeutsche Zeitung, 20.6.2016, www.sueddeutsche.de/ wissen/gesundheitswesen-wes-brot-ich-ess-1.3042404.
17 John Virapen: Nebenwirkung Tod, 7. Aufl. 2015, S. 106, 108.
18 Spiegel Online, 14.7.2016: „Pharmahonorar für Ärzte – Vielen Dank für die Millionen“.
19 Nach https://correctiv.org.
20 Steven E. Nissen/Kathy Wolski: “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes, “New England Journal of Medicine 356 (24) 2007, S. 2457-2471.
21 Charles Ornstein u.a.: “Now There’s Proof: Docs Who Get Company Cash Tend to Prescribe More Brand-Name Meds, “ProPublica 17.3.2016, online: www.propublica.org/article/doctors-who-take-company-cash-tend-to-prescribe-more-brand-name-drugs, abgerufen am 18.7.2016.
This text is part of a series of articles with the following additional contributions:
1) Trained demigods – How doctors become drug dealers
2) Visit from the Rep – Mendacious Friendship based on the script
4) Off-label – crossing borders as routine
5) Purchased Observers – When the doctor becomes the “researcher.”
6) Like Lubricated- When doctors let themselves be greased
7) “As you do to me, so do you” – reciprocity as the secret of success
8) Softened – education and training as brainwashing
9) Insatiable Renters – The uncanny power of paid opinion leaders
10) Among Gorillas – Silverbacks call the shots
11) As KOL to the Golden Nose – Why “Key Opinion Leaders” have taken care of it
Application observation, AWB, Seeding Trial, non-interventional study, Corruption, Harald Wiesendanger