October 06, 2008

Mass Hysteria

by Peter Pitts

Last month two Massachusetts scientists won the Albert Lasker Medical Research Award. Commonly called "America's Nobel Prize," the Lasker Award is the country's most prestigious honor for medical breakthroughs. It was given to BayState biologists for their work on gene expression, the results of which show unprecedented promise in the efforts to combat disease.

The win is a testament to the strength of Massachusetts' medical research community. Yet local legislators have recently instituted a law likely to undermine the inter-industry partnerships essential to just this sort of cutting-edge scientific discovery.

In August, Gov. Deval L. Patrick signed a bill requiring pharmaceutical firms to report to state officials any payments over $50 made to physicians, academic scientists, or other medical professionals. The information - including the names of the people getting paid - will be posted on a public Web site. The bill goes into effect Jan. 1, and provides for fines of up to $5,000 for non-compliance.

This disclosure law is supposed to increase transparency. State officials are understandably worried that money from drug makers could unduly influence research results or physicians' practices. And they want to ensure that patients know if their healthcare provider has a financial incentive to recommend certain treatments.

But publishing this information suggests that there is something wrong with medical professionals working with the pharmaceutical industry. There isn't.

Physicians rely on drug makers for up-to-date information about new treatments. Drug makers in turn rely on doctors for feedback on the real-world clinical effects of their pills - the kind of information that can't be acquired in a laboratory.

The law is also unnecessary. This summer, the drug industry announced strict new limits on sales personnel, banning them from buying lavish meals or giving gifts of any sort during meetings with physicians. Since physicians are often only available for non-patient work during lunchtime, sales reps will only be allowed to pay for the occasional modest meal at a doctor's office, as long as it's "in conjunction with informational presentations."

And under the new guidelines, sales reps are strictly prohibited from passing along information that is anything other than educational.The BayState's disclosure law will stigmatize the doctors it publicizes. Many might leave Massachusetts in favor of a state with a healthier regulatory environment. That would make a bad situation worse: Nearly a quarter of the state's physicians are already considering leaving or are planning to leave because of legal controls on clinical practices, according to a Massachusetts Medical Society report.

The law will also have a dampening effect on academic medical research.

Funds provided by private firms don't compromise lab work they're essential to getting the research off the ground in the first place. Many of Massachusetts' academic medical centers are currently conducting research in partnership with pharmaceutical companies.Scientists are likely to give up on research projects that require corporate sponsorship for fear of jeopardizing their reputations.

Biopharmaceutical companies employ around 55,000 Massachusetts residents, according to the Center for Labor Market Studies at Northeastern University. If researchers start leaving the state to avoid stigmatization, investment dollars and jobs will follow. And that means fewer breakthrough cures from the commonwealth.

Ironically enough, this law's passage comes at a time when state legislators are making a concerted effort elsewhere to bolster the BayState's medical research industry. In June, Gov. Deval L. Patrick approved a 10-year, $1 billion biotechnology initiative, meant to expand investment in state-level research projects.

This new disclosure law hinders those efforts. It will stifle life science innovation, choke off investment dollars into new cures, and destroy medical sector jobs. Patients, physicians, researchers, and average citizens alike should be outraged.

Posted at 12:32 PM | Permalink | Comments (0)
TrackBack (0)

October 03, 2008

European Commission Calls for More Healthcare Cowbell

by Peter Pitts

Too slowly for some, too swiftly for others, and without any apparent interest by most, the European Commission is moving forwards in its efforts to lubricate the anemic channels through which pharmaceutical companies can communicate with patients (otherwise know as “people”).

According to an article in Europolitics, “The European Commission is standing firm on its objective of authorising pharmaceutical laboratories to communicate directly with patients on the benefits and risks of their prescription products.

The full Europolitics article follows – but here are some tidbits to whet your appetite:

“The idea is also to respond to the expanding use of communication tools - in particular the internet - and patients' growing responsibility for their treatment.”

Wow. Reality. What a concept!

“While the Commission has always denied wanting to authorise advertising for prescription drugs, it was expected to make a clear distinction between non-professional information' and advertising' if the industry is allowed to communicate directly with patients.”

But:

“The EU executive took a step backwards, however, on communication channels: exit radio and TV broadcasting, which "does not protect patients against unsolicited information".

However:

“… the Commission intends to maintain the print media in its proposal. It nevertheless puts emphasis on the internet, saying it offers "almost unlimited access to information without taking account of national borders."

So, there can be advertising , but not advertising.

And for all you DDMAC fans out there:

“The European Agency for the Evaluation of Medicinal Products (EMEA), based in London, would also play a role: laboratories would have to notify their information prior to publication and the EMEA would have 60 days to express any compliance objections, after which the information would be published.”

And to make things even more confusing:

“For the monitoring of information, the Commission is expected to propose an ex-post mechanism (after dissemination of information to patients). The member states will define the rules. They could nevertheless set up prior monitoring - and clearance by the competent authorities - for information for which it is hard to make a distinction between non-promotional information' and advertising'.”

Note: This is the difference between federation and confederation. It is also a lesson in why concepts like … preemption ... are so important. But I digress.

Here is the compete article from Europolitics:

Prescription Drugs: Pharmaceutical Firms Authorised to Inform Patients

The European Commission is standing firm on its objective of authorising pharmaceutical laboratories to communicate directly with patients on the benefits and risks of their prescription products. In a draft directive due out in late October(1), the EU executive is expected to stand up to the criticisms of health care professionals, sickness insurance bodies and several patient and consumer organisations, which accuse it of trying to do away with the European ban on advertising for prescription drugs.

With this proposal (subject to co-decision), of which Europolitics obtained a copy, the Commission intends to iron out the differences between national laws, which range from allowing information that is strictly supervised by drug regulatory authorities, to public private partnerships between health care professionals, patient associations and industry.

QUALITY CRITERIA

While the Commission has always denied wanting to authorise advertising for prescription drugs, it was expected to make a clear distinction between non-professional information' and advertising' if the industry is allowed to communicate directly with patients. Its answer is that "the content of authorised information must be defined". According to the proposal, industry would be authorised to communicate on the instructions for drug use, prices, changes in packaging, warnings on side effects, the absence of scientific studies and prevention and treatment support measures. Information on human health and illnesses as such is not concerned.

Quality criteria are established: the information must be objective and non-biased, take patients' needs and expectations into account, be based on factual and verifiable data (declaration on the extent of evidence), up-to-date, reliable, factually accurate and not misleading, comprehensible to patients and the general public, stem from a clearly identifiable source and compatible with the summary of product characteristics and patient information brochures as approved by the competent authorities. Comparisons between drugs are prohibited.

INTERNET AND PRINT MEDIA

The EU executive took a step backwards, however, on communication channels: exit radio and TV broadcasting, which "does not protect patients against unsolicited information". This eventuality, discussed by the Commission in its public consultation documents, was rejected by the member states, even the most liberal stakes like the

UK, but also by laboratories. The European Federation of Pharmaceutical Industries and Associations (EFPIA), for example, had informed the Commission that its members did not wish to engage in direct advertising as in the United States and that reflection on passive information via TV, radio and the print media tied into that. However, the Commission intends to maintain the print media in its proposal. It nevertheless puts emphasis on the internet, saying it offers "almost unlimited access to information without taking account of national borders". And it adds that "specific rules on site surveillance should be put in place to take account of the cross-border nature of the information provided on internet and to allow cooperation between member states". Patients could, for example, write to industry in any of the EU's 23 official languages to request information in that language.

EX-POST MONITORING

For the monitoring of information, the Commission is expected to propose an ex-post mechanism (after dissemination of information to patients). The member states will define the rules. They could nevertheless set up prior monitoring - and clearance by the competent authorities - for information for which it is hard to make a distinction between non-promotional information' and advertising'. The national authorities will have to ensure that information is accessible to people with disabilities, unless this requires too much paperwork in laboratories. Such a regulated mechanism nevertheless does not rule out voluntary regulation by industry or co-regulation by industry and the public authorities. At a debate in the Health Council, on 10 June in

Luxembourg, most of the member states expressed a preference for prior monitoring of information. Sweden noted, however, that possibilities for ex-post monitoring could lower the administrative costs involved (see Europolitics 3548).

It will also be for the member states to ensure that companies are fined or taken to court for "repeated and serious cases of non-compliance" with the new rules. The name of the company would be made public. The European Agency for the Evaluation of Medicinal Products (EMEA), based in

London, would also play a role: laboratories would have to notify their information prior to publication and the EMEA would have 60 days to express any compliance objections, after which the information would be published.

The Commission also gives itself the possibility to revise the directive five years after its entry into force. The proposal concerns only prescription drugs, since existing EU rules authorise advertising by laboratories for over-the-counter drugs, under certain conditions.

Posted at 02:20 PM | Permalink | Comments (0)
TrackBack (0)

September 29, 2008

Who Spends What on Healthcare?

by Peter Pitts

On both sides of the aisle, politicians repeatedly criticize the amount of money America spends on health care.

They’ve got a point. Our $2 trillion healthcare tab is quite steep. But we're not alone — every other developed nation, even those with universal healthcare systems, struggles with high healthcare costs.

Indeed, people in other healthcare systems often pay more than Americans do, once taxes are taken into account. Add in the high non-monetary costs of rationed or denied care and waiting lists, and suddenly the vaunted European systems commonly touted as models for the United States don’t seem like a good deal at all.

Let’s dive into the numbers.

In the US this year, a family of four with an employer-based PPO will face about $15,609 total in healthcare costs. Of this amount, the employer will pay on average $9,442, and the employee will contribute $3,492 in premiums and $2,675 for co-pays and other expenses. Employee premiums are about 6 percent of the median family’s annual income — less than what that family spends on food.

In Canada, while the percentage of taxes used to provide healthcare varies, it is estimated that 22 percent of taxes collected went to the health system in 2004. Several provinces, including Quebec, Ontario, Alberta, and British Columbia, also charge additional premiums. Canadians may spend their own money to receive private treatment for procedures or drugs that are not covered by the government system.

Citizens of the United Kingdom pay 11 percent of each pound they make in weekly income between $198 and $1,326 for care through the state-run National Health Service, plus an additional one percent of income over $1,326 per week. That’s nearly double what Americans pay.

The co-pay for drugs is low, but many drugs are not covered, often because they are not considered cost-effective enough to justify inclusion in the government’s plan.

But what if you need one of those drugs? Well, you can kiss your NHS benefits good-bye. Anyone who uses his or her own money to buy drugs outside the NHS will find him or herself shut out of the system.

In Germany, coverage from a public sickness fund currently can range significantly in cost, from around 12.2 to 16.7 percent of income, with the employee paying a bit under half. This coming fall, premiums are set to be standardized — and healthcare experts anticipate that they will be set around 15.5 percent. Private patients can generally expect to pay more than they would in the public system.

In France, employees contribute only 0.75 percent of their salaries towards medical care, but they also pay a 7.5 percent General Social Contribution, the majority of which is earmarked for the health system. This base coverage reimburses people for the bulk of costs for doctor visits and for a portion of the costs of medications. On top of the government coverage, almost all French residents have supplementary coverage from a mutuelle, which costs approximately 2.5 percent of salary.

When compared to the U.S., the fact is that the health care systems in Europe and Canada don’t save citizens much at all.

Health reform is urgently needed in this country, and cost-cutting will be a critical component of any reform efforts. Despite its supporters’ claims to the contrary, government control of the healthcare marketplace is anything but a ticket to a lower-cost healthcare paradise.

Posted at 08:16 AM | Permalink | Comments (0)
TrackBack (0)

September 24, 2008

Sunshine Superman

by Peter Pitts

A little sunshine is always welcome in central Indiana.

Starting next year, Eli Lilly and Co. will reveal how much money it pays physicians for speeches and consulting. According to a report in the Indianapolis Star, Lilly president and chairman, John Lechleiter, will announce the new policy in an address to the Economic Club of Indiana today.

"Lilly is striving to be a leader in improving transparency across our industry," Lechleiter said in a statement. "As Lilly continues to look for more ways to be open and transparent about our business, we've learned that letting people see for themselves what we're doing is the best way to build trust."

Under Lilly's registry of physician payments, they will list fees to physicians who serve the company as speakers and advisers. That information, which likely will include physicians' names and hometowns, will be posted starting in the second half of 2009 on a publicly accessible Internet database, Lilly said.

In 2011, Lilly plans to expand the database to include payments, updated annually, for clinical research and other provisions called for in the Physician Payments Sunshine Act pending in Congress.

For a big drug company to be the first to disclose its payments to doctors "takes a lot of courage," said Sen. Herbert Kohl, D-Wis., a co-sponsor with U.S. Sen. Charles Grassley, R-Iowa, of the Sunshine Act.

In 2004, Lilly became the first drug maker to voluntarily make public data on its clinical trials of new drugs. Last year it began publicly reporting its educational grants and charitable contributions, becoming the first in its industry to do so.

Posted at 11:11 AM | Permalink | Comments (0)
TrackBack (0)