Big Pharma Under Fire for Reverse Plagiarism

The pharmaceutical industry is coming under fire for allegedly hiring ghostwriters (writers who work for pay, but not a byline) to write positive reports/analysis of clinical tests on drugs with possible efficacy issues - and then recruiting notable doctors to stick their names on it. This issue has been bandied about for months and suspected for longer, but now U.S. Senator Charles Grassley from Iowa is renewing the fight.

Is the fact that this possibility has surfaced doesn’t surprise me troubling? Even before I declared my concentration in health/medicine reporting, I was aware of the corruption and rampant abuse of power by what is referred to as Big Pharma. Government deregulation and regulation on a slew of business and healthcare policy issues end up benefiting these corporate entites, whether allowing unapproved drugs and drugs with possible side effects to go on the market before they are fully vetted by the FDA or removing/weakening price caps on prescription drugs so that Pharma can charge more for less and profit from donations of life-saving drugs to Third World countries. And of course there are the deceptive drug ads that have had varying levels of regulation over the last two decades.

Journal articles are an important “first draft” introducing new developments in medicine to the public and are among the sources used by health professionals and medical reporters in their story research. Doctors and reporters already look at journal articles with a wary eye, and the likely possibility of journal articles being fabricated can be even more detrimental to the trust people place in such written work.

And that doctors would sign on to put their names on these works they haven’t written - even if they agree with what is being written - is egregious and says they condone this deceptive practice. Like the regulations placed on drug advertisements, all that would be needed is for the doctors to acknowledge that this IS NOT their work. It would be better if it were, but if this is the way they want to roll, then disclose your affiliations.

It is tantamount to plagiarism.

LOCAL: PCVB Seeks More Health Care Conferences, Sporting Events

(previously published here at www.thebulletin.us)

By: Heather J. Chin, The Bulletin
07/24/2008

"America's life sciences meetings destination" may become the newest Philadelphia marketing slogan, according to officials from the Philadelphia Convention & Visitors Bureau. They unveiled their business strategy on Tuesday, aimed at drawing more visitors with a variety of programming - including more health care conventions.

Forty percent of all meetings held at the Philadelphia Convention Center are devoted to health care and life sciences, while 55 percent are held in Philadelphia-area hotels. PCVB hopes increased marketing and cooperation with economic-development groups to recruit related students and businesses to the region, the city will become a global destination for meetings.

The greater Philadelphia area hosts many health care; pharmaceutical and biomedical research; manufacturing; and marketing facilities, including U.S. branches of international corporations.

"Not only do we have the community to hold those conventions, but also the connections in the life sciences to make these things happen," said Mr. Jack Ferguson, executive director of PCVB. From being within driving distance from 85 percent of "big pharma" in the country and [institutions] of higher education, "we've got the infrastructure to do it and an expanding convention center to host."

Philadelphia is the 12th most-visited U.S. city for international visitors, and tourism rose by 27 percent last year, to around 550,000 visitors, according to U.S. Department of Commerce figures, due in part to the strength of foreign currency against the dollar. This increase was valued at $1.2 billion in economic impact for the region, PCVB President Tom Muldoon told a regional business news publication.

The convention center, at 15 years old, is set to expand from the current 440,000 square feet of exhibit-hall space to 700,000 square feet. Construction could finish in January 2011, at an expected cost of between $700 million and $800 million.

In addition to more life-science conventions, PCVB's business plan for the upcoming fiscal year aims to attract individual and group tourism, multicultural groups and sporting events. The Philadelphia Sports Congress, a division of PCVB, has already hosted the U.S. Olympic Team Trials in Table Tennis and Gymnastics, generating over $20 million in economic impact.

The PCVB and the Sports Congress, also continue to build on the Philadelphia 2016 Olympic bid, further branding the city as an international and Olympic sports destination city.

"If our city is to compete in a global marketplace, we need to continue to tell the Philadelphia story to people around the world so they choose to travel to America's birthplace," said Mayor Michael Nutter.


Heather J. Chin can be reached at hchin@thebulletin.us


©The Evening Bulletin 2008

FDA Approves A New Insulin Pump

(previously published at www.thebulletin.us)

By: Heather J. Chin, The Bulletin

07/03/2008

At the same time that a wireless insulin pump for diabetics has been approved for marketing and public use by the U.S. Food and Drug Administration (FDA), its regulators are reconsidering the standards they use to approve diabetes medications.

The FDA began hearing from a panel of outside diabetes experts, cardiologists and statisticians on Tuesday as to whether the agency should require pharmaceutical companies to prove, through extensive long-term clinical research studies, that their drugs reduce heart problems and do not increase risk of death in order to gain FDA approval.

Diabetes is a disease where the body either does not produce or properly use insulin, a hormone that converts food into energy. Prescription drugs used to treat type 2 diabetes - the most common form, where a person's body either produces too little insulin or rejects insulin - are currently evaluated on the basis of whether they are proven to control blood-sugar levels.

The wireless insulin pump that has been approved is known as the OneTouch Ping glucose management system and is produced by Animas Corp., a medical device company from West Chester, that is a subsidiary of Johnson & Johnson Corp. in New Brunswick, N.J. It makes it easier for individuals with diabetes to calculate and inject themselves with the proper dose of insulin.

This reconsideration of regulatory standards is the result of questions that arose last year after an analysis of a popular diabetes drug, Avandia, showed that although taking it lowered blood-sugar levels, its use also increased the risk of heart attack in individuals.

FDA research into the issue yielded no actionable results, and additional trials by Avandia's manufacturer, GlaxoSmithKline, which has operations in the Philadelphia area, will likely not be ready until 2014.

The panel's opinions may influence and affect that approval of both new diabetes drugs and those that are already on the market.

However, there are some scientist even from within the FDA, who are skeptical of the value of tying risk of a side effect (heart attack) to the approval and availability of a drug whose target goal is to treat [low blood sugar and] diabetes.

Still, consumer advocates, lawmakers and diabetes organizations express concern over the risk of possible side effects.


Heather J. Chin can be reached at hchin@thebulletin.us

©The Evening Bulletin 2008

Big Pharma Agrees To Stricter Ad Rules

(previously published here at thebulletin.us)

By: Heather Chin, The Bulletin

06/23/2008

Washington - Top drug manufacturers including Johnson & Johnson, Merck and Pfizer agreed last Monday to a six-month moratorium on direct-to-consumer television advertising for new prescription drugs and limitations on how doctors are used in their ads.

The agreements came amid increasing pressure from the Congressional House Energy and Commerce Committee and the American Medical Association (AMA) following earlier controversy surrounding deceptive advertising for anti-cholesterol drugs such as Lipitor, Procrit and Vytorin.

In signed letters, the executive directors of Johnson & Johnson, (J&J), Merck & Co., Merck/Schering-Plough, and Pfizer agreed to take steps towards implementing these recommendations.

Meanwhile, the Pharmaceutical Research and Manufacturers of America (PhRMA) agreed to further meetings with the committee before agreeing to any particular changes at the moment.

All of the companies agreed to adhere to the AMA's guidelines as to the use of actors and health professionals. Specifically, they will continue to identify instances in which an actor portrays a physician, as well as whether the actor was compensated for their appearance. Johnson & Johnson will discontinue use of doctors entirely to discuss the benefits of a drug.

In the letters, each company also stated that the six-month moratorium simply formalized their existing practice of educating doctors before moving to consumer communications.

"We have adopted internal guiding practices on direct-to-consumer advertising for prescription drugs [that] requires our operating companies spend at least six months after approval of a new medicine educating health professionals before commencing a direct-to-consumer advertising campaign," wrote William C. Weldon, chairman-CEO of J&J.

He added that since the advertisements are in line with FDA approved labeling and measures of outcomes, they are an important tool to provide information to patients and physicians, and "a particular fixed period of time for an advertising moratorium is appropriate in all circumstances."

Rep. John Dingell, D-Mich., and Rep. Bart Stupak, D-Mich., chairmen of the committee's oversight and investigations panel, said they were pleased with this response, but wanted the drug companies to adopt the recommended two-year moratorium.

According to Mr. Stupak, he and Mr. Dingell called for the May 8 hearing of the House Energy and Commerce Committee, entitled "Direct to Consumer Advertising: Marketing, Education or Deception?", to both renew pressure and renew the struggle within Congress to strengthen government regulation over such TV commercials. It was also a step towards granting the Food and Drug Administration the right to force changes in the ads before they air.

"Although we appreciate the drug companies' willingness to change some of their business practices, they have not agreed to all of our requests, which would protect consumers from misleading and deceptive advertising," said Mr. Stupak.

Even with these agreements and the potential for future legislation, the debate will go on. Part of that debate lies in the fact that running these ads is mutually beneficial for both the pharmaceutical companies and the TV industry.

Since 1997, when the government relaxed rules on TV and radio ads, pharmaceutical companies shortened the warnings on side effects in their commercials and spent about $14 million on broadcast and cable TV ads for prescription drugs.

In 2007, drug makers spent over $5 billion on direct-to-consumer ads, according to Nielsen Monitor-Plus; more than half of that on television.

"The drug and TV and cable industries have formed a cabal here to protect their revenues," said Gene Kimmelman of Consumers Union, an advocacy group in favor of stricter limits on direct-to-consumer drug marketing.

Ken Johnson, a PhRMA vice president, challenged that in a May article in the Wall Street Journal. He insisted that consumer advertising for prescription drugs "brings patients into their doctors' offices and helps start important doctor-patient conversations about conditions that might otherwise go undiagnosed or untreated."

Still, many consider the ads to be intentionally misleading. "Direct-to-consumer ads often portray drugs through rose-colored glasses by including more information about a drug's benefits than risks," said Dr. Nancy Nielsen, AMA President-elect, in testimony at the congressional hearings.

"Imbalances in these ads can diminish patient understanding of certain drug risks, and increase the need for an ongoing dialogue between patients and physicians about the benefits and risks of prescription drugs," Dr. Nielsen added.

Reporting contributed by AdAge.com and The Wall Street Journal.

Heather Chin can be reached at heather.jean.chin@gmail.com

©The Evening Bulletin 2008