Tuesday, January 27, 2009

Connect the dots between medical groups and pharm and medical device industry

On Saturday, The Boston Globe ran a front-page story about how three medical groups have threatened to pull their annual meetings out of Boston if the state of Massachusetts restricts drug and medical device promotions at medical meetings and requires the industry to publicly disclose the money it gives to medical groups and prominent physicians in research, consulting and educational fees. What the article neglected to mention was that all three of the medical societies named in the article -- The American Academy of Allergy, Asthma and Immunology, the American Society of Gene Therapy and the Heart Rhythm Society -- have received major funding from the pharmaceutical and medical device industry over the years.

Hmmm...could it be that the pharmaceutical and medical device industry had something to do with these rather unsubtle threats?

Spokespeople for two of the groups quoted in The Globe article said they were concerned that the proposed guidelines won't allow presentations by drug company employees at meetings in Massachusetts. According to local public health officials, that's simply not true. The regulations do allow company scientists to present at meetings but the presentations must be objective and cannot be used to flagrantly promote company's products. What a marvelous concept -- and a major departure from business as usual.

One need only visit the medical groups' websites to see the extent of industry funding behind these groups. In the March 2008 annual meeting program of the American Academy of Asthma, Allergy and Immunology, for example, the list of commercial supporters filled a full page, ranging from pharm companies such as GlaxoSmithKline, Merck, Schering Plough and AstroZenica to biotechs like Sepracor, Genentech and Teva Specialty.

Likewise, the Heart Rhythm Society's list of supporters for its May 2008 meeting in San Francisco includes all the major makers of cardiac medical devices: Medtronic, Boston Scientific and sanofi aventis (labeled Diamond Level sponsors), Boehringer Ingelheim (an Emerald Level Sponsor) and Biosense Webster, a subsidiary of Johnson and Johnson (alas only Ruby Level).

Similarly, the American Society of Gene Therapy listed Genzyme as its "partner" for its annual meeting last May in Boston and 15 biotech and medical device companies as major contributors and patrons.

So if The Boston Globe really wanted to do its homework, it could ask these three medical groups just how much money all this corporate sponsorship translates into every year and what kind of pressure the industry put on them to howl about regulations that were, by the way, designed to protect consumers.

Wednesday, January 21, 2009

Stringent privacy safeguards a must for electronic medical records

It's good to see that our new President is eager to fund the installation of an ambitious electronic medical records system that links doctors and hospitals with patient records, according to The New York Times. But as a number of legislators and consumers advocates quoted in this article warn, the problem of protecting the privacy of these records is not one to be taken lightly. I agree.

When I was a medical reporter for The Boston Globe, someone sent me the medical records of a Kennedy who had recently been hospitalized for drug addiction (no it wasn't Ted or Caroline). The records of this patient, who was at the time an elected official, had been sent by accident to a health-care professional who passed them along to me as an example of how porous the system of medical records security was. I convinced my editors that we should not disclose this person's identity or his addiction and there the matter rested.

However, if such sensitive medical information is posted online, one can only imagine the heightened potential for abuse. Anyone who has ever had their credit card number and/or identity stolen knows that information stored online remains far from secure. As fast as IT specialists come up with ways to secure online information, through encryption, passwords, what have you, intrepid hackers (often backed up organized crime syndicates) figure out ways around the security. Anyone who doesn't think this will happen with electronic medical records is fooling themselves.

Sensitive medical information -- about public and private figures -- will be stolen not only by crackers bent in selling them to interested parties, but will be available for viewing (and potential theft) by all the people within the health-care system who are currently allowed under law to see those records, including claims clerks, hospital personnel, researchers, pharmacies and law enforcement personnel.

A few years ago, a low-level employee at a LA hospital who had access to Farah Fawcett's medical records leaked information about her cancer recurrence to a gossip rag before the actress had had a chance to inform her family. That was bad and the employee was rightfully fired. But think about how many more prying eyes will have access to celebrity medical records when Obama's ambitious medical records project gets off the ground.

This is why stringent privacy safeguards must be put in place to protect electronic medical records. Not only should it be a major felony to sell any personal health information without the patient's consent but patients should be apprised of any disclosures of their electronic data for unauthorized purposes. Patients should also be able to demand that sensitive information, about treatment for drug addiction and psychological ailments, abortions and HIV tests, for example, be segregated from the rest of their medical records. And as Robert Pear in the Times article notes, patients -- or state officials acting on their behalf -- should be able to recover damages from any entity that improperly uses or discloses personal health information.

Finally, such privacy safeguards should be made into law by Congress, not left up to the federal Health and Human Services department, where regulations are often watered down as a result of aggressive lobbying by insurance companies and other interested parties. It's the least we should do to protect our right to privacy.

Thursday, January 15, 2009

Are newspapers under the financial gun getting sloppy with health coverage?

We've all heard the ominous reports about newspapers: as their print advertising disappears under the double whammy of the Internet (craiglist etc) and the recession, metropolitan newspapers are being forced to downsize, lay off veteran writers and cut back on coverage. Over the last few years, these financial woes have had a direct effect on the dwindling resources that newspapers like The Boston Globe can devote to investigative and enterprise reporting. And now, alas, the belt-tightening seem to be cutting into the very bone of news coverage and analysis -- at least at The Globe (where I worked for 13 years).

Consider these two examples. On Saturday, The Globe ran an opinion piece on its op-ed page about Massachusetts' proposed regulations requiring disclosure of financial ties between doctors and the pharmaceutical industry. The piece was written by Peter J. Pitts, who identified himself as president of the Center for Medicine in the Public Interest and a former associate commissioner of the FDA. Pitts neglected to mention that he is also senior vice president for global health affairs at the PR firm Manning Selvage & Lee, which represents Eli Lilly, GlaxoSmithKline, Pfizer and more than a dozen other pharmaceutical companies. In addition, the Center for Medicine in the Public Interest (which Pitts founded) receives the bulk of its funding from the pharmaceutical industry. Indeed, the fact that Pitts’ close ties to the drug industry went undisclosed when he was a guest on Fred Goodwin’s Infinite Mind show (which runs on several NPR affiliate stations) was a big part of the controversy that erupted over this NPR show last fall, according to Slate.

In his op-ed piece, Pitts said he favored limiting disclosure of financial conflicts to the industry's "marketing efforts," which would mean that drug and medical device companies would not have to disclose payments to medical researchers for consulting, speaking or anything to do with the research of their products. And, in fact, the regulations, as currently written, do not cover "bona fide services" for drug and medical device manufacturers such as consulting services, research, participation on advisory boards, company-sponsored presentations and education (back story). In other words, the regulations exempt much of the payments to doctors that create the conflicts of interest that health advocates worry about most.

As a shill for Pharma, Pitts is entitled to his opinion. The question in my mind is why The Globe's editorial page ran his piece without vetting Pitts' conflicts and making readers aware of them. I can only speculate that this kind of sloppiness might not have happened with a more fully staffed board of veteran editorial writers.

I draw my second example from a news story published today in, again, The Globe about new evidence that atypical antipsychotics -- drugs like Zyprexa, Risperdal and Seroquel -- have the same level of heart risks as older antipsychotics do. As The New York Times reported, the finding (published yesterday in The New England Journal of Medicine) is the latest in a string of reports contradicting the long-held assumption that these new antipsychotics are safer than the older and much less expensive drugs that they replaced. As it turns out, the new atypical antipsychotics, which have become blockbuster drugs prescribed for all kinds of off-label uses, double the risk of sudden cardiac death in patients.

The Globe article (written by a correspondent, not one of newspaper's regular medical writers) failed to put the latest finding in the context of the growing controversy over these drugs. For example, there is no mention in the article about earlier findings that drugs like Zyprexa, Seroquel and Risperdal are no more effective than the older antipsychotics in treating schizophrenia or dementia-related psychosis in elderly people. Or that the makers of these drugs are under investigation for illegally marketing these drugs for off-label uses to vulnerable patients (such as children and the elderly) in whom the previously known side effects (excessive weight gain and diabetes) are particularly risky.

Ironically, readers had to plow through to the Business section of The Globe to find that Eli Lilly, the maker of Zyprexa, is about to announce a $1.4 billion settlement with federal and state investigators over allegations that the drug company knew about the drug's dangerous side effects but launched an aggressive campaign to market Zyprexa for myriad off-label uses anyway.

In an earlier, less financially constrained, era, would a veteran medical writer or editor have thought to put these two pieces of news together in one place to give readers a fuller picture of the story? One can't help but wonder.

Thursday, January 8, 2009

Inauspicious omen for journalism's fate

I came back from vacation this week only to be greeted with bad news: Pharmalot, Ed Silverman's blog on the pharmaceutical industry, is no more. How disappointing! The demise of Pharmalot not only creates a big hole in coverage -- for me and many other reporters and bloggers -- but it is an inauspicious omen. If a large metropolitan daily like the Star Ledger (owned by Newhouse, a publishing powerhouse) can not see its way toward continuing such an incredibly useful source of news, one has to wonder what that augers for the future of good journalism overall.

Sure, there are plenty of other good health blogs, but Pharmalot was unique. To begin with, it was one of the few blogs that hewed to some form of objectivity, posting good and bad news about the pharmaceutical industry day in and day out. Silverman also covered the industry with greater depth than most other news-oriented blogs, such as the WSJ's health blog (which tends to cover a broader range of health news).

Equally important, Silverman was bolder than the Wall Street Journal and The New York Times in consistently delivering scoops about malfeasance in the drug and medical device industry. For example, as Senator Charles Grassley's investigations into conflicts of interest among doctors and researchers on the industry's payroll began to unfold last summer, Pharmalot was usually the first to post the news, followed by the mainstream press.

Finally, Silverman's inexhaustible postings were almost always accurate and fairly presented. As a result, Pharmalot developed a loyal following, as can been seen by the potporri of comments that were posted after each salacious scoop.

Now that Pharmalot has ceased to exist, I, along with many other health bloggers, will have to work that much harder to sift through and break news about the pharmaceutical industry -- a reality that industry executives will no doubt welcome. No, this is not a good start to the New Year at all.