From CSM: A number of charges against the pharmaceutical industry damages its credibility and further erodes public support.
By Gregory M. Lamb | Staff writer of The Christian Science Monitor
Big Pharma is in danger of joining Big Oil and Big Tobacco as one of the bad boys of American industry. A slew of revelations have stung drugmakers in recent months - from charges of hiding unflattering clinical trials to studies showing a link between the use of antidepressants in children and suicidal thoughts. The companies' stance against allowing Americans to buy cheaper drugs in Canada has further eroded public support.
Now, a steady stream of critical books - with titles such as "On The Take" and "The $800 Million Pill" - lambastes the way the companies do business.
"It's obviously frustrating," says Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA), the industry trade group. "We think it's the result of a barrage of distorted allegations, and we are trying to fight back." The charges have "obscured the fact that the US pharmaceutical and biotechnology research industry is the most innovative ... in the world," he says, supplying 60 to 70 percent of the world's new medicines.
Nevertheless, the charges keep coming. In June, New York's attorney general sued GlaxoSmithKline for, among other things, suppressing clinical findings that its antidepressant drug was ineffective in children and teens and possibly could cause suicidal behavior. The drug industry has since announced it will establish a voluntary database of clinical studies. But some in Congress, as well as the American Medical Association and medical journal editors, are calling for a mandatory registry that would make public all clinical trials, even the ones where the drugs failed to work.
Then last week, advisory panels to the federal Food and Drug Administration (FDA) urged the strongest possible warnings on the use of antidepressants in children.
What's more, the current publicity about antidepressants "almost certainly" will lead to more lawsuits against drug manufacturers, says Richard Daynard, an expert in product liability and consumer protection who teaches at Northeastern University in Boston. People will say "these guys did know [about the problems]. They should have told me," Professor Daynard says.
The drumbeat of revelations has damaged the industry's credibility. A majority of Americans (55 percent) now think drug companies should be more closely regulated and two-thirds of Americans say drug prices are unreasonably high, according to Harris polls this year. Most significantly, only 44 percent say pharmaceutical companies serve their customers well. That's down 35 percentage points since 1997, the biggest drop in approval among any of the 15 industries the poll tracks. Only four industries - health insurance (36 percent), oil (32 percent), managed care or HMOs (30 percent), and tobacco (30 percent) - now rank lower.
Big Pharma is not the first industry to enter the doghouse of American public opinion. The 1970s gasoline shortages and the infamous 1989 spill from the oil tanker Exxon Valdez off the Alaskan coast have made Big Oil a longtime member of the bad boys club.
Big Tobacco has an even longer history, although many Americans assume it got its comeuppance in 1998 when US state attorneys general won a gigantic $206 billion settlement against cigarettemakers.
Drugmakers do have a stronger case to make than the tobacco industry, says Daynard, who has led efforts to make that industry legally responsible for tobacco-induced deaths, diseases, and disabilities. "What the drug industry can always do is say, 'Well, that was a bad product. We're sorry about that one. And we should have put a somewhat different label on this other one. But all our other stuff is fabulous and, you know, you need it."
"It's big industry, and people are prejudiced against large industries like the oil industry," says Mel Harkrader Pine, a veteran public-relations expert in Purcell-ville, Va., who has represented both Mobil and the treated-wood industry when they were under attack.
Part of the problem is that drug companies are a victim of their own success, he says. "We went through this in the '70s and early '80s [in the oil industry] until business went down the tubes," Mr. Pine says. "People liked us better when we weren't making as much money."
But critics say it's practices not profits that has gotten Big Pharma into trouble.
"[C]ontrary to its public relations, this is not a very innovative industry," writes Marcia Angell, a former editor in chief of the New England Journal of Medicine (NEJM) and author of "The Truth About the Drug Companies," in an e-mail. "[T]he notion that the pharmaceutical companies discover lifesaving drugs is largely myth. Of the 487 drugs they brought to market in the past six years, 78 percent were classified by the FDA as not likely to represent improvements over drugs already on the market, and 68 percent didn't even contain new chemical compounds (just old drugs in new combinations or formulations)."
The current patch of criticism that has come upon PhRMA is "deserved," adds Dr. Jerome Kassirer, another former editor in chief of NEJM and author of "On The Take: How Medicine's Complicity with Big Business Can Endanger Your Health." "[T]hey exaggerate the amount of money that's used to produce new products. They are producing too many drugs that don't have any special added value, a bunch of 'me too' drugs."
"Obviously, it's hard for someone to understand what's wrong with going across the border into Canada and getting a needed drug for a lower price," says PR guru Pine. He says Big Pharma would benefit from the same advice he gives all his clients: "Be authentic and sympathetic."
From Business week:
What the Doctors Aren't DisclosingA new study shows how authors of medical journal articles flout rules on revealing conflicts of interest
A group of researchers at Duke University scoured 746 studies on heart stents published in medical journals over the course of a year and were shocked to discover two huge omissions. First, 83% of the papers failed to disclose whether any of the authors were paid consultants for companies, even though many journals formally require that information. And of those articles specifically describing clinical trials, 72% didn't say who funded the research. When it comes to policing their disclosure rules, says lead author Kevin Weinfurt of the Duke Clinical Research Institute, "these journals should be doing better."
Virtually every medical organization urges physicians to be up front about their financial ties to industry. It's especially a concern when doctors who publish studies about drugs and medical devices receive funding from the companies that make those products. Over the past few years, a spate of safety warnings and product recalls has left journal editors fearful that company-paid researchers might be filtering their results to highlight the positive. So the publications have toughened up their disclosure policies, hoping that transparency by itself would neutralize conflicts of interest.
The Duke study shows that even when authors do divulge their connections, some statements are less than forthright. In all, 168 authors out of 2,985 made disclosures in the journal articles, which were published in 2006. Through simple Internet searches, the Duke team discovered that some physicians who said they had no conflicts of interest in fact served on advisory boards of companies that make stents. One person co-founded a stent company. (The Duke paper doesn't name doctors.)
The report reveals just how deeply corporate interests have infiltrated medical research. The top funding sources named in disclosure statements were stentmakers Johnson & Johnson (JNJ), Boston Scientific (BSX), and Medtronic (MDT), as well as drugmakers Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY). The last two co-market the blood thinner Plavix, which is widely prescribed to stent patients.
Contacted by BusinessWeek (MHP), spokespeople for Bristol-Myers Squibb, Boston Scientific, and Sanofi said in e-mails that they require authors to disclose all financial support from their companies. (J&J and Medtronic did not respond by publication time.)
BUILT-IN LIMITATIONS
Some journal editors gripe that there's only so much they can do. Once they issue disclosure rules, they have no choice but to trust authors to follow them. "I'm not a cop. I'm not the FBI," says Dr. Catherine DeAngelis, editor-in-chief of the Journal of the American Medical Assn. With several thousand authors contributing every year to her publication, DeAngelis says, she can't expect her editors to research every disclosure to determine whether it's accurate. And she's frustrated so many authors are resisting the call to disclose. "It should be a no-brainer," DeAngelis says. "It doesn't mean the worthiness of the paper is marred. But if they're not disclosing because they think it's marred, then maybe it is."
Transparency has some built-in limitations. If all authors consistently disclosed every possible conflict of interest, the world would be awash in information that's hard to interpret. After all, most disclosure statements don't say how much money the authors receive, whether they're paid in cash and/or stock, or what services they provide in return. "The whole system is pretty slipshod," says Dr. Jerome P. Kassirer, former editor-in-chief of The New England Journal of MedicineOn the Take: How Medicine's Complicity with Big Business Can Endanger Your Health. "When you know an author has a conflict of interest, you're still in the dark." and author of
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