Prozac Profit Ploy- Rename and Sell Under "Sarafem"

By Ed Silverman

Lilly says Sarafem will help ease a severe premenstrual ailment. Critics call the drug -- Prozac by another name -- a profit ploy
 

The women in the magazine ads are all aglow. Sporting big smiles and carefree demeanors, they are poster children for happiness and serenity.
 

These are the qualities Sarafem, a new name among prescription drugs, is supposed to create in women who suffer from a little-known ailment called PMDD, or premenstrual dysphoric disorder, a variant of premenstrual syndrome.
 

The medicine, approved by regulators last year, is being widely promoted by its manufacturer, Eli Lilly & Co., as a godsend to menstruating women who otherwise would experience severe mood changes, sadness and irritability.
 

If only it were that simple.
 

A chorus of doctors and insurers say Sarafem is little more than a cleverly timed marketing ploy, because the drug is really a renamed version of Prozac.

The patent on the blockbuster depression medicine expires this summer, and Lilly is scrambling to compensate for sales that will be lost to cheaper generics.
 

Fueling the debate is a controversy over PMDD itself. Only 5 percent of women may experience PMDD, which some psychiatrists believe is questionable ailment. As a result, critics say Lilly is stigmatizing women by suggesting they suffer from a mental illness each month. Rather than demonstrating a genuine interest in women's health, they charge Lilly's move underscores the lengths to which drug makers will go to protect profits.
 

"Lilly has done the wrong thing. Calling it Sarafem is deceptive. It's sort of like a little white lie," said Mickey Smith, director of the Center for Pharmaceutical Management and Marketing at the University of Mississippi. "There's an insidious element in this. "They ought to just say they've found a new way to use Prozac."
 

For its part, the Indianapolis-based drug maker maintains it has done nothing wrong. Sarafem was designed in response to requests from women and their doctors who were seeking assistance in treating a little-understood ailment, according to Laura Miller, a Lilly spokeswoman.
 

"PMDD is an underrecognized and undertreated disorder. Women have told us for years that they've been told it's something they have to live with or it's all in their heads," she said. Miller also noted that there are other instances in which more than one trademark exists for the same drug being used to treat different ailments.
 

Nonetheless, Lilly faces a huge dilemma when it comes to Prozac, which generated $2.6 billion in sales last year. Unless Lilly wins a court battle over patents, which Wall Street seems to think is unlikely, Prozac sales are forecast to drop by one-third next year, according to Hemant Shah, a securities analyst who follows the drug industry.
 

By recasting Prozac as a new drug, though, Lilly stands to gain if doctors write prescriptions specifically for Sarafem. Right now, each drug costs nearly $3 a day for a month's supply.

But as soon as a generic is available, the cost of Prozac is likely to drop by as much as 70 percent, according to the drug industry's usual rule of thumb.
 

However, thanks to quirks in insurance coverage, Sarafem would continue to command a higher price that will be paid by insurers, at least those insurers that agree to underwrite the medication. Under this scenario, Lilly may be able to generate more revenue than the Indianapolis drug maker might otherwise if it hadn't conceived Sarafem.

"The whole reason they did this is to keep sales up," said Terry Leach, director of pharmacy services at Horizon Blue Cross and Blue Shield of New Jersey.
 

If a doctor writes a prescription for Sarafem, the pharmacist can't fill it with a generic Prozac unless they call the doctor and get permission to switch, he said. For that reason, Leach said, Lilly has incentive to price Sarafem as a branded product.
 

Of course, not every insurer plans to go along. WellPoint Health Networks, a large health-maintenance organization based in Thousands Oaks, Calif., doesn't plan to cover the cost of either Sarafem or Prozac once the generic version becomes available this summer, according to Rob Siedman, the company's chief pharmacy officer.

Coverage is an issue for others, too. The Health Care Payers Coalition of New Jersey, a nonprofit buyers consortium that represents self-funded businesses and labor health plans, recently denounced Lilly for aggressively promoting Sarafem. The group's officials worry that a high-priced drug will be too readily prescribed for women who do not need it.
 

"This is going to get a lot of women taking Prozac, a psychotropic drug that effects the brain and has side effects," said David Knowlton, a former New Jersey health commissioner and coalition lobbyist. "I'm not saying price isn't an issue, but we're seeing an escalation in their marketing, which tends to drive people to a drug."
Indeed, Lilly's marketing has been aggressive.
 

From August, when the Food and Drug Administration approved this new use of Prozac, through January, the drug maker spent $17 million to promote it to consumers, according to Competitive Media Reporting. During the same period, an additional $16 million was spent to promote it to doctors and in medical journals, according to IMS Health, a market-research firm.
 

Within a few months of launching Sarafem, Lilly's advertising ran afoul of regulators. The FDA cited the drug maker for running a television ad that was "misleading, lacking in fair balance and in violation" of federal law, according to a letter sent last November by the agency to Lilly officials.
 

The 60-second ad showed a frustrated woman trying to pull a shopping cart out of a tangled group of carts in front of a supermarket. The ad then said: "Think it's PMS? It could be PMDD," but it never distinguished between the two illnesses or specifically defined PMDD. The FDA complained the ad "trivializes the seriousness of PMDD."
 

The ad campaign, which has been prominent in women's magazines, already has had an effect. Between September and February, the number of prescriptions written by doctors for Sarafem increased sevenfold, while the number of prescriptions written for Prozac declined, according to IMS Health.
 

This trend worries Althea O'Shaughnessy, a Princeton gynecologist and reproductive endocrinologist. She believes too many women may react to the Sarafem ads by asking their doctors to write prescriptions. But she worries that such requests may be inappropriate because most women never experience PMDD.

"The ads make it seem that you just take the drug and all the problems go away," O'Shaughnessy said. "I worry that physicians will prescribe it because of patient demand. But it's not a wonder drug or a cure-all. And only a very small percentage of women even suffer from PMDD. Even PMS is a very loose term for symptoms."
 

The controversy over PMDD was never fully settled by the American Psychiatric Association. The organization, which oversees diagnoses, lists the ailment in both the appendix and the main section of a widely cited compendium of disorders called the Diagnostic and Standards Manual IV, which is the equivalent of the Bible among mental-health specialists.
 

But a listing in the appendix is reserved for a diagnosis lacking sufficient evidence for validity, said Sally Severino, a former professor of psychiatry at the University of New Mexico School of Medicine and a member of a specially convened APA round table that, in 1998, was held to settle the PMDD debate.
 

"The real question is whether PMDD is a valid diagnosis. If it is, you should be able to prove it in some way," she said. "But we can't ever seem to get any consistency about what symptoms should qualify for this diagnosis.
 

"It's all very confusing. And by listing it in both places, the APA is talking out both sides of its mouth."
 

Ed Silverman covers the drug industry and can be reached at (973) 392-1542 or esilverman@starledger.com.
 

New Jersey Star Ledger June 6, 2001
 

---

DR. MERCOLA'S COMMENT:

As I said in April:
 

Folks, believe it or not I was a drug doctor in my early medical career.
 

I was probably one of the first doctors in the country to use Prozac for PMDD (the new term for PMS), in the late 80s. I actually reported its use to Eli Lilly back then, as it seemed to work so well. It is amazing to see them actually market it for that purpose a dozen years later.
 

I was actively involved in diagnosing and treating depression, and because emotional wounding is one of the most common causes of illness, there was plenty of it around.
 

I got quite good at prescribing and managing the drug side effects. In the mid 80s when I was prescribing them, only the first generation antidepressants were available and they had (and still have) plenty of side effects.
 

Prozac was the first of the second generation antidepressants known as selective serotonin reuptake inhibitors (SSRIs). They were absolutely incredible, as they frequently worked and they had so many less side effects.

When they worked, I would look like a superstar, as if I had "cured" the depression.
 

Well nothing could be further from the truth. The real solution to improving depression is cleaning up the diet (Sugar Blues by William Dufty 1975), exercising and addressing the emotional wounding that occurs that precipitated the cause.
 

While I still recommend using these types of drugs as a temporary measure in selected cases, I hardly ever prescribe them anymore, especially for PMS.

Additionally, Sarafem and Prozac (fluoxetine hydrochloride) both are fluorine-containing drugs, which would thus further elevate fluorine exposure from sources like drinking water, toothpaste, etc.
 

However, the marketing of Sarafem for PMS is a very dangerous situation, because occasionally women experience what they assume is PMS. However, sometimes it soon turns out that they are actually pregnant and so their period never comes. By recommending widespread use of "Prozac" by another name for PMS, there will undoubtedly be a small percentage of women who are unknowingly exposing their very young unborn babies to these drugs, during a period where growth and development is going on at an enormous rate.
 

The management of PMS certainly includes diet and exercise, it also involves optimizing the female hormones. This is done by balancing the adrenal hormones. I usually use salivary hormone testing to guide my treatment, but most of the work ultimately involves using our therapists to address the emotional wounding that usually precipitated the adrenal's impairment.
 

Related Articles:

Prozac for PMS (PMDD)?

The Links Below Jump To Pages On Whatever Web You Are In
Table Of Contents	Search This Web		Navigation Help Page
Write To Karl Loren -- He Pledges To Answer EVERY Personal Message, Personally.  Click here or on his name in the box below.
The Links Below Are To Various Web Sites Published By Karl Loren
Karl Loren Web	Vibrant Life Web		Karl Loren's Book
Super Colostrum	Bulk MSM		Heart Disease
Emmessar	Happiness		Arthritis
Instead Of	Chelation Therapy		Super Colostrum (2)
Karl Loren's Catalog Store		Central Page For All 12 Webs!

E-Mail Address: First Name: Last Name:

E-Mail Address: