The bill, SB-270, would require drugmakers to adopt a marketing code of compliance that, among other things, forbids them from buying meals for doctors at continuing-education events and from compensating doctors for attending such events. The bill also would require transparency in pharmaceutical companies’ interactions with healthcare providers. The General Assembly’s Public Health Committee has approved SB-270, and the bill awaits approval by the full Assembly.

In an interview with Connecticut newspaper The Day, Liz Power, a Pfizer spokeswoman, said the bill would hinder the relationship between doctors and the company’s field representatives, who provide “critical information about prescription medicines” to busy doctors. I don’t see how the bill would reduce sales representatives’ ability to convey information about their drugs. Surely they can do that without giving doctors gifts.

The employees who visited Hartford asserted that the bill would discourage drugmakers from doing business in the state. This claim might be grounded in Power’s statement to The Day that the bill would be expensive to implement. But the bill echoes the rules laid out in the Physician Payments Sunshine Act of 2009, which was signed into law in March 2010 as part of Congress’s healthcare-reform legislation. Indeed, Power told The Day that many of SB-270’s proposed regulations overlap with new federal requirements. As long as the reporting requirements and restrictions on gifts to doctors are part of federal law, it’s hard to see what Pfizer would gain by moving from Connecticut to, say, Utah.

By fighting what seems like a reasonable attempt to ensure transparency in relationships between doctors and drug companies, Pfizer ends up looking like it wants to use questionable techniques to persuade physicians to prescribe its drugs. I don’t see how the bill would cost the company a significant amount of money, especially if Pfizer will have to comply with similar federal rules anyway. For the same reason, I’m equally puzzled about how the bill could influence Pfizer to transfer jobs out of Connecticut.

So far, the company has not given clear explanations about how SB-270 would interfere unfairly with its operations or harm its bottom line. Unless the company makes a more convincing case, its resistance to the bill will seem like much ado about nothing.

Considered as a single event, the discovery of particulates in a small percentage of therapies produced at the Allston Landing facility might be seen as a normal occurrence. But this episode continues a troubling trend. During the fall of 2008, FDA inspectors found “significant deviations from current good manufacturing practice” at the plant, including the “failure to establish and follow written procedures designed to prevent microbiological contamination of drug products purporting to be sterile.”

The consequences of this failure were illustrated in June 2009, when Genzyme discovered a virus in the plant’s production equipment. Although the virus strain was not shown to cause human infection, Genzyme temporarily halted production at Allston Landing to sanitize the facility.

In this context, Friday’s announcements raise legitimate questions about whether Genzyme is taking sufficient measures to ensure the sterility of products filled at Allston Landing. I think that FDA and the company should begin investigating whether systemic problems are affecting the plant’s operations.

The new contamination also highlights the need for FDA-approved alternatives to the medicines produced at the facility. As things stand now, a prolonged halt in production at Allston Landing could seriously affect the quality of life of thousands of people. Branded or generic competition for Cerezyme and Fabrazyme, for example, would benefit patients.

The society was referring specifically to a report issued earlier this year by EMEA, which highlighted some of the failings of the agency and other regulatory authorities to provide clear information on the risks and benefits of medications in a language that is clear and understandable to patients. The report was based on the results of a survey of regulators, healthcare providers, patients and consumers across Europe.

EURORDIS has shown a particular interest in this survey because of the increasing involvement of patients and consumers in treatment decision-making. According to the society, this is especially true for rare disease patients who are often very involved in the management of their disease.

In its report, EMEA highlighted the importance of simplified information provision on the benefits and risks of medicines. According to the EURORDIS release, this “is particularly critical to orphan drugs which are often developed under exceptional circumstances and for which there is less long-term information about safety than for regular drugs.”

As the number of patients going it alone and seeking information on their disease and treatment options continues to escalate, the importance of reliable and good quality information becomes even more critical. The fact that the public has free access to an inordinate amount of information, which is largely unregulated, via the Internet, is naturally a concern to regulators, healthcare professionals and drug manufacturers so the EMEA’s efforts to address this problem are indeed commendable.

According to the agency’s report, regulators need to take more responsibility for the dissemination of reliable information on medicines to healthcare professionals and patients. This information should clearly present the benefits and risks of a therapeutic in lay language, and should identify patient subgroups for whom risks or benefits may differ. It is recommended that warnings and clinical trial information should also be presented in understandable terms.

EMEA, along with its patient, consumer, and healthcare professional working groups, have now outlined an action plan, which aims primarily to optimize the provision of regulatory information that fulfils patients’ and healthcare professionals’ expectations in a number of ways and through different tools and channels. While this is indeed an admirable undertaking, one might ask how feasible it will be to create, in essence, a one-stop information shop for patients and healthcare professionals that is not only comprehensive, but is also sufficiently publicized so that the public are aware of its existence and opt to visit this trusted information source over and above any other.

Naturally, it will be mission impossible to prevent patients from basing decisions on potentially inaccurate and/or unregulated information, but the idea of a harmonized public access information source, issued by regulators, is very exciting. According to the report, ideally “a central web portal provided by EMEA and national competent authorities” could be used to disseminate trusted information on medicinal products.

Suggestions relating to the expansion of the existing Eudrapharm database of information on all medicinal products authorized in the EU were made within the report. Although the idea of this database, which is available in most European languages, is an interesting one, the information that it currently stores on approved medications is severely limited and is of no real use to patients as it stands. As such, if it were to be considered a valuable resource for healthcare professionals and patients, it will require a significant investment of time and money.

According to Francois Houyez, Health Policy Officer at EURORDIS and patient representative at the Patients’ and Consumers’ Working Party (PCWP) of the EMEA in this week’s EURORDIS release, “This is the first time that patients, doctors and regulators are thinking together to define the benefit-risk ratio of drugs and how best to communicate it. Patients who take orphan drugs have been asking for more balanced information, not only information about the risks they are exposed to, but equally important the benefit they can expect.” He concluded, “This project and the recommendations coming out of it are a real step forward in this direction.”

I couldn’t agree more!

That’s why news from Ecuador made me do a doubletake.

Last Monday, Ecuadorean President Rafael Correa gave local officials the power to issue compulsory licenses that enable Ecuadorean companies to bypass patents and produce inexpensive versions of various drugs. Correa’s decree did not specify which, or even how many, drugs’ patents could be bypassed. The licenses, issued according to the World Trade Organization’s rules, are intended to expand access to medications and improve public health.

To my surprise, Pfizer (New York), GlaxoSmithKline (GSK, London), Bayer (Leverkusen, Germany), and others reacted to the announcement with equanimity. In a statement, these and several other companies said, “We accept the democratic decision … to use this extraordinary legal measure, observing the rights and responsibilities” laid out in international law. “No legal right of any kind can take precedence over the interests of public health,” they added.

This reaction is 180° from the opposition that Brazil and Thailand faced in 2007 when they used this tactic. The International Federation of Pharmaceutical Manufacturers and Associations criticized Brazil for not collaborating with Merck (Whitehouse Station, NJ) before its government issued a compulsory license for the AIDS treatment Efavirenz. After Thailand issued a compulsory license for Abbott’s (Abbott Park, IL) Kaletra, the company said it would no longer register new drugs for sale in that country.

I could not find statements responding to Correa’s directive on these companies’ websites and I don’t know why they reacted differently than Merck and Abbott did in 2007. Maybe Pfizer, GSK, Bayer, and the other companies coordinated their response to improve their public images. Or maybe their statement reflects a changed attitude about the limits and ethics of patent protection.

Whatever their motivation, these companies’ endorsement of compulsory licenses will likely set a precedent that makes other drugmakers more willing to accept this legal measure. Compulsory licensing is sanctioned and regulated by international governments and trade organizations. I think it can be a valuable tool that saves patients’ lives, and I’m heartened by the thought that Big Pharma might be more tolerant of this measure in the future.

In a press statement, Senator Jon Kyl (R-AZ) said that the economic stimulus bill, which allocated $1.1 billion for CE research, could allow the government to micromanage medicine and use CE research to ration healthcare. He introduced the Preserving Access to Targeted, Individualized, and Effective New Treatments and Services Act of 2009, which would bar the federal government from denying insurance coverage of a treatment based on its cost.

House Democrats introduced a discussion draft on Friday that could allay fears of healthcare rationing. The draft would establish a Center for Comparative Effectiveness Research and also an independent Comparative Effectiveness Research Commission, which would oversee the Center.

The Commission would include representatives of consumers, physicians, insurance companies, clinical researchers, and payers. The draft states that the Center would have to “develop rigorous scientific methodologies for conducting comparative effectiveness studies” and that “all aspects of the prioritization of research, conduct of the research, and development of conclusions based on the research shall be transparent to all stakeholders.”

I think the Democrats’ discussion draft would ensure that CE research wouldn’t let the government “dictate treatment,” in Senator Kyl’s words. Sharing the results of CE research would likely improve the quality of healthcare and make consumers’ and patients’ lives easier. To my mind, CE research would provide benefits too great to be dismissed. The discussion draft shows how it could preserve doctors’ and patients’ rights to exercise their own discretion.

The US Food and Drug Administration is focusing its efforts on Institutional Review Boards (IRBs), which approve and monitor clinical trials. The agency recently told a hearing of the House Subcommittee on Oversight and Investigations that it will require IRBs to register with them, beginning in July 2009. The registration process will be the basis for a database of IRBs, and this tool will help FDA monitor and inspect these bodies. The agency also said it would establish voluntary guidelines for drugmakers and IRBs.

FDA was stirred to action when the Government Accountability Office (GAO) reported that it had successfully set up a phony IRB, registered it with the US Department of Health and Human Services, and gotten approval to test an imaginary medical device on human subjects. The GAO also obtained a real IRB’s approval for a fake protocol for human-subjects research, although the protocol contained demonstrably false claims that the device to be tested had FDA approval.

Last week the Association for the Accreditation of Human Research Protection Programs gave Pfizer its accreditation for protecting the rights of its human clinical trial subjects, and the company pledges to carry out trials according to the International Conference on Harmonization’s international standards of good clinical practice. Despite Pfizer’s good will, I think FDA needs binding, not voluntary, rules to ensure that all pharmaceutical companies protect their trial patients’ safety. Human life is precious and demands no less.

Last Tuesday, lawmakers in the state of Washington considered a bill that bans drug companies from buying patients’ prescription records for marketing purposes. A woman testified before the state House’s Health Care Committee about being contacted by pharmaceutical marketers. After she switched from a branded drug to a cheap generic alternative, marketers attempted to persuade her to use a new version of the branded drug (for which there was no generic equivalent) instead.

The bill would prohibit this kind of contact, ostensibly making it easier for the state to save money on prescription-drug reimbursement. But an equally important effect would be to maintain patients’ privacy by keeping medical information away from pharmaceutical companies.

The bill seems to have momentum. One Washington legislator opposed a similar bill aimed at protecting doctors’ privacy, but supports the new patient-oriented bill.

As I said in regard to a similar New Hampshire law, I believe drug companies are entitled to perform market research to stay competitive and innovative. Yet I think few of us would want our personal information open to public scrutiny. I think the Washington bill and the New Hampshire law strike the right balance between promoting pharmaceutical industry and protecting individual rights.

According to Woodcock, analysts observe that pharmaceutical companies buy outsourced ingredients to take advantage of “lower, less stringent standards in some parts of the world.” But doesn’t FDA exist to ensure that there is no such advantage to be taken? Even if other countries have lower safety standards, FDA is supposed to be a firewall to protect patients from unsafe products.

In a letter to Woodcock, Brown took the next logical step: he asked her to estimate the volume of ingredients sourced from countries with weak safety standards, to estimate the cost of protecting the public from potentially contaminated ingredients, and to name the tools FDA needs to hold drugmakers accountable.

Brown also put industry, in the person of Gerald Migliaccio, Pfizer’s vice-president of quality, in the hot seat. Migliaccio said cost savings was a major reason that pharmaceutical companies outsource ingredients and processes. In a letter to Migliaccio, Brown asked how much Pfizer saved each year by outsourcing.

In theory, Pfizer would pass its savings along to consumers, but Brown dryly noted, “There is no evidence that outsourcing is translating into any savings for patients in the US.” On the contrary, Americans pay higher prices than anyone else for prescription drugs, Brown said. On top of that, America must spend extra money to mitigate the risk posed by ingredients produced in countries with weak safety regimes.

Brown’s questions raise the point that outsourcing should benefit patients as well as industry. It’s fine for industry to profit from outsourcing if it brings efficiency and savings. But advantages for industry should not come at patients’ expense. Brown’s investigations won’t necessarily have major results, but I’m glad to see a legislator taking his responsibilities seriously and using his power to exercise oversight for the public good.