Doctors: Drug rep may be behind smear

[JohnMack]

Source: Wall Street Journal

{Yer blind, FDA,
Yer blind, FDA, you must be out of yer mind, FDA

...sung to the tune "Six Months Out of Every Year"; Damn Yankees

For the complete lyrics, see today's post to Pharma Marketing Blog}


Panel Rejects Bid
For Over-Counter
Sale of Mevacor
By ANNA WILDE MATHEWS

A Food and Drug Administration advisory committee, for the third time, rejected Merck & Co.'s bid to sell the cholesterol drug Mevacor without a prescription, saying it wasn't clear that consumers would use the medication correctly.

The 10-2 vote leaves little hope Merck can win regulatory approval. It is also a setback for GlaxoSmithKline PLC, which has bought the U.S. over-the-counter marketing rights to the drug. The decision is the latest sign of the regulatory hurdles blocking such switches, at least when a medication treats a complicated condition without obvious symptoms. The FDA typically follows the advice of its expert panels.
[Blockbuster Numbers]

Mevacor, approved as a prescription medication in 1987, is the first of the blockbuster class of drugs known as statins, which cumulatively racked up U.S. sales of $6.4 billion in the first six months of this year, according to IMS Health. A successful bid to market it without a prescription would be a watershed. A cholesterol drug that patients could grab from pharmacy shelves, without visiting a doctor, could mean significant changes for how those at risk of heart disease are treated in the U.S.

Newer and more powerful statins, which include Pfizer Inc.'s best-selling Lipitor and Merck's own Zocor, now available generically, have long overtaken Mevacor in prescription use. But Merck argued that the potential market for its over-the-counter version was the 14 million Americans at moderate heart risk who aren't being treated. Glaxo had said it would sell OTC Mevacor for around $1 to $1.50 a day. The companies would get three years of exclusive over-the-counter sales, a significant windfall.

Yesterday, members of the panel said they still weren't persuaded that the right patients would take the drug without a doctor's guidance. Similar objections came up when the agency rejected Merck's previous applications, in 2000 and 2005. "We haven't learned how to present information in a way that allows consumers to make informed decisions for themselves," said Arthur Levin, director of the Center for Medical Consumers in New York, who was the committee's consumer representative. One panel member abstained from the vote.

In a statement after the vote, Merck Vice President Edwin L. Hemwall said company officials are "disappointed in today's outcome" and "felt we presented a compelling case to the committee."

A spokeswoman for Bayer AG, which holds the U.S. rights to market an over-the-counter version of the statin Pravachol, said the company is meeting with the FDA to address questions about its hoped-for switch, and "provide the agency with the information it needs." She said she "couldn't say" what the implications of yesterday's vote are for Pravachol.

FDA reviewers, in their presentations to the committee, highlighted concerns about the results of Merck studies designed to simulate how consumers would respond to the company's proposed labeling and other informational materials. A number of study participants who believed they should take Mevacor didn't fully fit the complicated criteria for taking the drug, which included having LDL, or "bad" cholesterol, within a certain range and several other requirements.

Agency reviewers also said some consumers who were already on more potent prescription statins improperly thought they could simultaneously take Mevacor, or wanted to swap their existing drugs for the Merck product.

The regulatory record on over-the-counter switches is mixed. In the past several years, the FDA has allowed them for some drugs that treat obvious symptoms, including Schering-Plough Corp.'s allergy medication Claritin and heartburn treatment Prilosec, marketed by Procter & Gamble Co. Earlier this year, Glaxo was able to overcome the agency's initial concerns about safety and consumer comprehension and win permission to sell the weight-loss aid Alli on drugstore shelves.

The FDA's views may be evolving. The agency is examining the possibility of a new regulatory category, called "behind the counter," which would allow pharmacists to dispense certain drugs without a physician's prescription. A few drugs are already effectively sold this way, notably the emergency contraceptive Plan B, which is only supposed to be provided to women 18 and older without a prescription.

Write to Anna Wilde Mathews at anna.mathews@wsj.com

[JohnMack]

Source: Springfield State Journal Register

Doctors: Drug rep may be behind smear
Anonymous letter attacks physicians and their wives

By DEAN OLSEN
STAFF WRITER

Tuesday, December 11, 2007

Two Springfield doctors and their wives have asked local representatives of pharmaceutical companies if they know who mailed anonymous letters that accuse the couples of being heavy drinkers and engaging in professional and personal misconduct.

The letters might have been designed to silence the doctors’ questions about a new medicine, the couples’ lawyer said Monday.

The doctors — internist Carl Lawyer and family-medicine specialist Paul Smelter — and their wives, who also are health-care professionals but not physicians, haven’t received satisfactory responses from the drug reps, according to the couples’ attorney, Charles Watson.

In documents filed in Sangamon County Circuit Court, the couples say handwriting on the anonymous letters “is similar to” the handwriting of Beth Kallal, a Springfield-based representative of drugmaker Merck & Co. Inc.

The doctors are considering filing a defamation lawsuit, but haven’t done so yet, Watson said.

Kallal has filed court papers that deny any involvement with the letters. The couples’ assertion about her potential involvement with the letters is “based on a few incredibly tenuous and speculative conclusions,” the response says.

Kallal was one of several Merck reps in attendance at a dinner that Merck hosted for the couples Jan. 10, according to the documents. The other Merck representatives present were Casey Jacobs, Adil Ranes, Alex Ginos and David Finney, the documents say.

The dinner at Indigo restaurant was designed to “educate” the doctors about Merck’s new anti-shingles vaccine, Zostavax, the documents say. It featured an expert in infectious diseases from Rush University in Chicago.

Dr. Lawyer, who practices with Smelter at Physicians Group Associates, said in an affidavit that he asked the expert about potential cardiovascular side effects from the drug, but the expert wasn’t able to address his question.

Lawyer said Smelter told the speaker Zostavax would be too expensive for some of his patients. Zostavax, which is covered by some health insurance plans, costs $150 to $190 per shot.

A few weeks after the dinner, the doctors received copies of an anonymous letter that apparently referred to the dinner and had been mailed from Springfield, according to the documents.

The letter, which ends with the typewritten words, “a concerned Representative,” contained information that the couples say is “false, defamatory and otherwise professionally and personally extremely critical of” the physicians and their wives, Dorothy Lawyer and Ellen Smelter.

According to the documents, the letter “makes an accusation of excessive consumption of alcohol with the specific statement, ‘They (Dr. Lawyer and Dr. Smelter) and their spouses will order huge amounts of expensive alcohol, sometimes even ordering bottles (hoping to take them home).’”

Lawyer said in his affidavit, “I have not consumed an alcoholic beverage, at any time, in over 30 years.”

Asked if the letter might have been sent to persuade the doctors not to criticize Zostavax, Watson said, “One could reach that conclusion.”

Watson said the couples would not comment otherwise on the documents.

The documents ask that Kallal and Forest Laboratories rep Timothy Lyons be ordered to provide information about the letter.

Watson said the couples decided to seek information from Lyons because drug representatives who work in the Springfield area are “a fairly tight community of people.”

Lyons hasn’t responded to the couples’ request. He also didn’t return a phone message from The State Journal-Register. Merck’s media relations office also didn’t return a phone call from the newspaper.

The court documents touch on the issue of gifts that have raised ethical questions about the influence pharmaceutical companies can have on doctors.

Dr. Howard Brody, director of the Institute for the Medical Humanities at the University of Texas in Galveston, said it’s best for doctors not to accept any free lunches, free dinners or free medicine samples — all of which usually come with sales pitches from drug salespeople, he said.

Brody, a family physician, said his view is in the minority in the U.S. medical community. However, he said, patients can be the real losers when doctors are spun by the drug industry

“We physicians are not very insightful when it comes to how we are influenced,” he said. “There’s now a growing body of evidence that says that doctors who accept gifts and, in general, rely on the drug industry for information, are going to do what the industry wants us to do more often than not. We’re going to prescribe the more-expensive drugs. We’re going to prescribe drugs when perhaps the patient doesn’t really need a drug.”

Dean Olsen can be reached at 788-1543 or dean.olsen@sj-r.com