Dear Colleagues,
I am copying the message to the Evidence-Based-Health  list.
Up to my knowledge, we have not had in Colombia any similar threats of
legal action when considering inclusions/exclusions in our Essential Drug List,
although the list is certainly the basis for reimbursement within the system.
Pressure and lobby may exist but is asserted through more sophisticated but
perhaps equally or more effective fashion.

The whole issue also raises another point for discussion, that of the legal and
ethical implications of those developing, implementing and following (or not!)
clinical practice guidelines (CPG), even those that are evidence-based. I
thought such an action as that taken by Astra-Zeneca was bound to happen for a
CPG in a legally-minded society and high-stakes scenario as the US. Sobering
that it happened in Canada.

Regards,

Rodolfo J Dennis, MD MSc
Chairman of Medicine, Pontificia Universidad Javeriana
Bogotá, Colombia


Andrew Herxheimer wrote:

> E-drug: Legal innovation from AstraZeneca?
> ---------------------------------------------
>
> This report seems to put AstraZeneca beyond the pale.  We should tell
> them.
>
> Andrew Herxheimer
> <[log in to unmask]>
>
> *****************************************************
>
> [distributed as fair & non-profit use]
>
> Drug firm threatens suit over MD's product review
> MIRIAM SHUCHMAN
> Special to The Globe and Mail [Toronto]
> Wednesday, November 17, 1999
>
> A researcher who pointed out a cheaper alternative to a best-selling
> ulcer drug has been threatened with a lawsuit by the pharmaceutical
> maker in a case that is sending a chill through the medical community.
> Anne Holbrook, who evaluates drugs for Ontario, wrote that Losec --
> at $3 a pill, the most expensive ulcer drug covered by the provincial
> drug plan-- is essentially the same as two cheaper medications.
>
> At the Centre for the Evaluation of Medicines at St. Joseph's Hospital
> in Hamilton, Dr. Holbrook's job is to sift through all the data on a drug
> and offer an unbiased assessment of its risks and benefits. In 1997,
> the province asked her to lead a review of medications for heartburn
> or stomach ulcers. When multinational pharmaceutical firm
> AstraZeneca PLC disagreed with Dr. Holbrook's conclusions about
> Losec, she became the target of intimidating letters and legal charges.
>
> Her story has spread like wildfire among those who evaluate drugs. In
> a handful of other cases in recent years, drug companies have
> threatened to sue researchers or actually have done so. "But . . .
> when it happens to you personally, it's a little bit different; it's a
> little
> more unnerving," Dr. Holbrook confided. Other researchers now fear a
> further chilling effect on their work will prevent some from expressing
> their true opinions.
>
> Dr. Holbrook's troubles originated in a request by the Ontario Ministry
> of Health that she chair a panel of experts to formulate guidelines
> telling doctors how best to treat heartburn, ulcers and related
> conditions.  She and her panel read through mountains of studies,
> published and unpublished. By early 1998, they had compiled the
> guidelines. Dr. Holbrook, who is both a pharmacist and practising
> physician, sent the guidelines out for comments from every
> pharmaceutical company that makes products to treat heartburn,
> including AstraZeneca.
>
> The company's best-selling product is omeprazole, also known by the
> brand names Losec in Canada and Prilosec in the United States and
> Europe. The drug ranks among the top five most commonly prescribed
> drugs in the world.
>
> When it was introduced over a decade ago, it represented a
> breakthrough in the treatment of ulcers, providing relief from the pain
> and discomfort of that condition without the need for surgery. It's still
> an effective drug for people with ulcers, according to Dr. Holbrook's
> panel. The panel, however, concluded that Losec is very similar to
> two other ulcer drugs in the same class. Under the proposed
> guidelines, these drugs could all be used interchangeably. In practice,
> this means the province, which covers seniors and welfare recipients
> through its drug-benefits plan, could pay only for the cheapest. That
> would in effect leave out Losec -- and AstraZeneca objected.
>
> Ontario alone spent $65-million on Losec in 1997. In Canada that
> year, the drug brought in $280-million from seven provinces. If
> Ontario's provincial drug plan stops paying for it, other provinces
> could follow suit. The company's spokesman is a doctor of pharmacy,
> Murray Brown. He and Ann Holbrook graduated together from the
> University of Toronto's school of pharmacy in 1975. But now they sit
> on different sides of the fence. "I will be very honest with you," Dr.
> Brown said. "There were a lot of elements in the guidelines that we
> agreed with because that is where the science is headed. But there
> were a couple of fundamental decisions, and one was
> interchangeability, that we cannot accept and that were fundamentally
> wrong as far as AstraZeneca is concerned, because we feel there's a
> potential patient-safety health issue there."
>
> Dr. Holbrook said that she has reread all the studies and still comes to
> the same conclusion: Losec can be used interchangeably with the
> other drugs in its class. It didn't take long for the company to express
> its discontent with the proposed guidelines. On Feb. 26, 1998, Dr.
> Holbrook received a letter from a Toronto law firm, Smart and Biggar.
> It came across her fax machine stamped "urgent."
>
> The letter said that the firm was representing AstraZeneca and that
> the guidelines, "if distributed, would be unlawful, being contrary to
> the Food and Drugs Act." It urged Dr. Holbrook "to refrain from
> finalizing and distributing" them. The letter stated that the drugs under
> review by Dr. Holbrook have not been approved for the same
> indications by Health Canada. So, the law firm argued, she would be
> breaking federal law to suggest they are interchangeable. It
> concluded: "In the event that you proceed notwithstanding this
> warning you should assume that our client will take appropriate steps
> including the commencement of appropriate legal proceedings in order
> to protect its interests and to obtain compliance with the law."
> AstraZeneca's Dr. Brown said the company felt forced to take the
> legal route in order to ensure that the information on Losec in the final
> version of the guidelines was correct.
>
> "We got a draft of something to review," he explained, "and were
> reduced to providing some input. We didn't know whether the input
> was received; we didn't know whether it was acted upon, or even
> read." For her part, Dr. Holbrook found the letter threatening and
> unnerving. She wasn't sure what to do about it. She phoned the
> Canadian Medical Protective Association, the organization that
> represents physicians who are sued by patients. They told her that
> physicians on committees "are on their own."
>
> Next, she sought a legal opinion from the Ministry of Health, since it
> had contracted with her to lead the guidelines process. Ministry
> spokeswoman Alexandra Brown confirmed that the ministry had
> received a copy of the letter Smart and Biggar sent to Dr. Holbrook.
> Ms. Brown said the ministry wrote the law firm to clarify Dr.
> Holbrook's role as someone who was providing advice to government.
> According to Dr. Holbrook, the ministry's lawyers told Smart and
> Biggar that any further correspondence about the guidelines should be
> sent to the ministry. But that did not remove the possibility that legal
> action could be taken against her.
>
> At this point, Dr. Holbrook has not been sued, but the guidelines that
> she oversaw haven't been released. There has been no definitive
> resolution of the company's disagreement with the guidelines, and the
> threat of legal action continues to hang over her head. Ontario's
> Ministry of Health expects the guidelines to be published by the end of
> December.
>
> Normally, the conclusions of scientific papers are considered
> debatable, and those debates take place in medical journals and at
> scientific conferences -- not in courtrooms. But with the market for
> prescription drugs becoming increasingly competitive, "companies
> have to key on what are sometimes pretty  trivial differences between
> drugs in the same class, and . . . then become extremely aggressive
> about defending the fact that those differences matter," said Dr. David
> Naylor, dean of the medical school at the University of Toronto. He
> said such threats by drug companies are part of a growing trend.
>
> --
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