Big Pharma Physician, Heal Thyself

Sponsorship of doctors’ training sessions by drug companies in Germany has sparked concerns that it might unduly influence physicians’ decisions about what drugs to prescribe to patients and drive up healthcare costs.
Money is tempting some doctors to stray from the righteous path.

The event in June at the hotel in Berlin was open only to medical professionals. Markus Müller was reporting about research into anticoagulants. The title of the medical education course was “A Matter of the Heart: Stroke Prevention.”

But Mr. Müller's subject wasn’t research in general, but instead the situation at drug manufacturers Brystol-Myers, Squibb and Pfizer. Mr. Müller earns his money from Pfizer. Cost for the doctors in attendance: free.

Doctors eagerly sought the advanced-education credit they could earn by attending the event. In the program announcement, Pfizer also let the doctors know travel costs, hotel and meals would be generously subsidized — with a total of €762 (or $840) per person. The information Pfizer sent the Berlin Medical Association to announce the program unabashedly included Eliquis, the name of the company’s newest anticoagulant, in the title.

The dubious alliance of pharmaceutical industry and doctors is not a thing of the past despite anti-corruption steps and attempts at compliance. Advanced-education calendars of medical associations in both urban and rural areas are filled with offerings by pharmaceutical companies. The firms’ economic interests are almost always evident. For example, a seminar in the town of Waiblingen in southwestern Germany acknowledged the program had been “fundamentally determined” by a pharmaceutical company.

The medical profession’s guidelines, which are supposed to establish a clear demarcation between the pursuit of medical skills and commercial profit, are apparently ineffective. As are the political attempts to finally create a world where doctors truly act independently from drug companies’ commercial interests. Research conducted by Handelsblatt concludes as much.

This month, Germany’s federal government is scheduled to signal its support for a proposed law against health-industry corruption. The bill was crafted by Heiko Maas, the federal minister of justice and consumer protection. The proposal is timely. More than €1 billion seeps into murky channels annually, according to the central office for combating property crimes and corruption in the health industry.

But if Mr. Maas' law ultimately looks like the current draft, then questionable areas will remain. One of them is the ongoing medical education organized or sponsored by the pharmaceutical industry.

Consider a meeting in November at the Hotel Seehof Berlin not far from the picturesque Lietzen Lake. For three quarters of an hour, Sven Jansen spoke to doctors about the German government’s initiative to improve medical services to the public. His subject: “What Does This Mean for Me as a Doctor?”

It’s difficult for patients to judge whether a doctor allowed his or her instruction to be paid for by a company whose expensive medicine the physician is prescribing.

But Mr. Jansen wasn’t appearing as a doctor but as the head of the health policy and governmental affairs division at MSD, one of the world’s largest drug manufacturers. Basically, Mr. Jansen is a lobbyist for the pharmaceutical industry.

The educational offering was clearly tailored to MSD’s interests. The speaker before Mr. Jansen explained to the participants how “cardiovascular events” can be avoided. It’s a field in which MSD is intensely active with the drug Ingeny, for example.

In response to an inquiry about drug companies’ involvement in training sessions for doctors, Pfizer and MSD rejected any insinuation of corrupt behavior. Pfizer stated that all legal requirements have been met and “all educational contents are scientifically correct and not commercial.”

As did Pfizer, MSD referred to the Berlin Medical Association, which is responsible for supervising such events. In response to inquiry, MSD stated: “The medical association certifies these programs in advance and confirms this certification to us.”

In fact, questionable seminars received the blessing of the Berlin association. Dubious rules regarding certification create further wiggle room for the companies to look after their own turf in the healthcare market.

The enticements and entanglements are huge. Germany’s healthcare market is estimated to be worth €300 billion annually. In the profit-maximization systems of the pill-producers, doctors are one of the most important multipliers. They prescribe or recommend medicine. Companies with widely prescribed products can earns millions.

For their part, doctors are in dire need of advanced-education credit. Since 2004, physicians have been required to prove that they regularly freshen up their knowledge. An estimated 60 to 70 percent of all programs in advanced medical education are paid for by the drug industry, according to an investigation by the German Society for Hematology and Medical Oncology in 2013.

For years, the public has been assured that these sorts of questionable alliances were a thing of the past. For example, in 2013 the Federal Medical Association stated in its model advanced-education regulation that doctor training must be “free from commercial interests.” Most state medical associations included this requirement in their own guidelines.

The Berlin regulations likewise forbid the certification of advanced education “in which there are lectures by speakers with a management- or employment-relationship to a company in the pharmaceutical industry” — as in the case of MDS and Pfizer.

But here as well, it’s the fine print that matters. The guidelines allow for questionable exceptions.

For example, training can be artificially split into recognized and non-recognized sections through individual lectures. So if a doctor participates in training where one out of the three speakers comes from the pharmaceutical industry, the doctor doesn’t receive credit only for that single presentation by the drug company representative. A spokesperson for MSD said “the medical association was informed in the application that Mr. Jansen is an employee of MSD; accordingly, no points were awarded for his lecture.”

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The Berlin Medical Association confirmed this in response to an inquiry but also admitted that in the Pfizer case, it didn't even keep to this rule. A training point was not deducted for the presentation of the Pfizer representative nor was the partial certification made clear. The association said this was due to the “negligence of an new employee still in training.”

Or perhaps it was due to a flawed system. Even in the case of partial certification, it is not clear to outsiders whether the participants listened to the sales pitch of the pharmaceutical industry or left the room.

Christiane Fischer, a member of the ethics committee of the nonprofit organization MEZIS (an acronym for a phrase that roughly translates as “No Free Lunch”), demands that medical associations examine the contents of training seminars much more rigorously. And that they take tougher measures in the case of hidden exercises of influence.

But this apparently doesn't happen. The Berlin Medical Association appears to examine the training programs rarely. Instead, the association contents itself with an assurance from the medical program supervisor that the particular seminar doesn’t promote commercial interests. An association document from January in the possession of Handelsblatt says that “on the basis of this personal statement,” the leadership assures that “the requirements for advanced medical training are being adhered to.”

Patients have little insight into this cozy relationship. It’s difficult for patients to judge whether a doctor allowed his or her instruction to be paid for by a company whose expensive medicine the physician is prescribing to the patient. And if the health-insurance expenses rise because of unnecessarily prescribed or overly expensive medication, then the patient's monthly contributions also go up.

The anti-corruption group Transparency International is calling for a stop to this practice. “These forms of advanced training must be prohibited,” said Wolfgang Wodarg, a member of the management board.

But the opposite seems to be happening — as is demonstrated by the training session involving Teva. The producer of 10 billion tablets and a thousand tons of creams annually offered in Berlin in November a seminar titled “Asthma — What Has Been Proven to Work?”

According to two participants, a pharmaceutical representative introduced the topic. The doctors found advertisements on pens and posters for the Teva asthma medication DuoResp Spiromax. The company sees nothing wrong with this and asserts there are “extremely high standards of obligatory anti-corruption regulations that extend from a global behavior code to the advertising and sales guidelines for the German market.” Nor was the Berlin Medical Association particularly troubled by the case.

As with MSD and Pfizer, the association only conducted an examination after some doctors objected, and the group gave a tepid response. Teva got off with a warning. The association’s reason: The statements by the organizer and the scientific supervisor were “characterized by reasonableness.”

Also in the cases of Pfizer or MSD, no sanctions will follow. Instead, in response to inquiry came this general statement: “The Berlin Medical Association has chosen the path of critical dialogue with the submitter of the application, in connection with a sensitization to the alertness of the Berlin Medical Association.”

Quelle: dpa
</a> Big pharma says it's good for you.
(Source: dpa)

The degree of wakefulness in this regard in Germany's capital city is also shown in the political sphere. The draft legislation by Justice Minister Mr. Maas doesn’t provide a way to eliminate the indirect influencing on doctors. Up to now, the regulations consider only the bribing of a doctor to be a crime and include no penalties regarding “provision of benefit.” Whereas bribery is defined as including a concrete agreement to wrongdoing, the provision of benefit would consist of a general cultivation of commercial interest.

But this is the main problem. “The largest share of corruption in the health industry is based on provision and acceptance of benefits,” said Ms. Fischer of MEZIS. She considers advanced training and seminars organized by the pharmaceutical industry to be a legal loophole in Mr. Maas's proposal.

Most medical disciplines operate their own advanced-training academies. But the programs for specialists such as urologists and rheumatologists are generously co-financed by the pharmaceutical industry.

The website of the Academy of German Urologists in Düsseldorf, for example, lists contributions by companies ranging from Amgen to Fresenius Kabi to Takeda that allow participants to take courses at low cost. Takeda, for instance, supports a course in sonography with €5,000. Amgen's sponsorship amounts to €25,000.

A similar picture is presented by rheumatologists. For the 10th convention of their professional association, it eagerly sought external financing. According to a form obtained by Handelsblatt, “platinum sponsors” can enjoy a maximized marketing of their name for €30,450. The sponsors would get such things as displays of company logos on the home page of the convention and “on one of the large panels in the entrance area,” as well as the inclusion of charts and the insertion of brochures into the convention goody-bags given to participants.

Organizers and pharmaceutical companies reject any suggestion of influence peddling targeted at the participating doctors. A spokeswoman from Takeda explained that the company's support of these instructional activities occurs “independently of the use of its own medical products.”

There is always an express “contractual stipulation that the sponsors exercise no influence on the contents of the advanced training or the selection of speakers,” said Frank Petersilie, managing director of the Academy of German Urologists.

Even after June 30, 2016, individual citizens won’t be able to ascertain whether his or her doctor participated in a pharma-sponsored program — if the doctor doesn't want the information released.

Instead the pharmaceutical companies see themselves as benefactors of the health system — and they refer to doctors' obligations to engage in advanced education, in which the pharmaceutical industry participates in order to promote public health. “Doctors in Germany are required to participate in regular advanced training. They receive no subsidies from the state for this,” Takeda said.

Are doctors really dependent on the money of the pharmaceutical industry in order to educate themselves further? “No,” say members of NeurologyFirst, an initiative of German neurologists in favor of pharma-independent conventions and guidelines. The neurologists are working on a plan to totally exclude the industry from the advanced-training business.

But the pharmaceutical industry lures with the power of billions. None of the contacted companies gave information as to the exact amount of the annual budget for programs of advanced medical education.

Like Takeda, most of them refer to the rules of the association Voluntary Self-Monitoring for the Pharmaceutical Industry (FSA). This is an organization of 60 pharmaceutical firms that, among other things, has developed a transparency code which is supposed to reveal financial payments.

But this transparency will be inaugurated only at the middle of next year — and with significant limitations. “As you know, all researching firms will reveal payments to employees of partners in the health industry retroactively for 2015 on June 30, 2016,” said a spokeswoman for Amgen.

What she doesn't say is that after that date, individual citizens won’t be able to ascertain whether his or her doctor participated in a pharma-sponsored program — if the doctor doesn't want the information released. According to the code, doctors must agree in advance that their data be made public.

“The pharmaceutical industry,” said Mr. Wodarg from Transparency International, “always manages to find a way.”

 

Jan Keuchel is a Handelsblatt correspondent covering the German legal system. To contact the author: [email protected]