We recently posted an item discussing a New York Times article about Genentech’s drug Cerezyme . One reader posted a comment on that item, and her story is so compelling that we asked her if we could post it as a stand-alone blog entry. She agreed. Jessica’s story appears below, in which she describes the difficulties she’s faced in affording her prescription for Provigil, which she needs to treat her narcolepsy.
One of the reasons that Provigil is so expensive (about $200 for 30 tablets of 100 mg, and about $270 for 30 tablets of 200 mg) is that there is no generic version available. Why is there no generic version available? Largely because Cephalon (NASDAQ: CEPH), the manufacturer of Provigil, filed patent infringement lawsuits against generic drug companies that tried to bring a less expensive generic version to market. Then Cephalon paid them off, to the tune of more than $130 million, not to sell generic versions of Provigil until 2011 at the earliest. PAL member AFSCME District Council 37 Health & Security Plan is a plaintiff in a national class action lawsuit challenging these payoffs.
Earlier this week, it was reported that Cephalon’s CEO, Frank Baldino, got $13.5 million in compensation last year. This is much more than CEOs at other, much larger, drug companies earned last year, including Pfizer and Bristol Myers Squibb. This news will certainly be of no comfort to patients like Jessica.
Without further ado, here’s Jessica’s story. At her request, we’re using only her first name. The opinions expressed and events described below are hers and not necessarily ours.
Cephalon makes a similar claim as Genentech’s to provide “the drug free, if necessary, so that no one goes without the product because of its cost.” Cephalon’s PROVIGIL Assistance Program is solely administered by the National Organization for Rare Disorders (NORD). The NORD website asserts that their Patient Assistance Programs
“assist uninsured or under-insured individuals in securing life-saving or life-sustaining medications. In addition to the estimated 50 million Americans who have no health insurance, an increasing number of insured individuals have policies that do not reimburse for prescription drugs. Others have policies with low annual caps on prescription drug expenditures. NORD works closely with humanitarian-minded pharmaceutical and biotechnology companies to ensure that certain vital medications are available to those individuals whose income is too high to qualify for Medicaid but too low to pay for their prescribed medications.”
But it turned out Cephalon was not as “humanitarian-minded” as NORD would have you believ
When my health insurance dropped Provigil from their formulary in 2007, my Provigil copay jumped from $50/month to $234/month in addition to a $500 brand name deductible and my $130 monthly premium. I’m not sure why my insurer took Provigil off the formulary (I asked them and they didn’t know either) but I wouldn’t be surprised if it was in response to Cephalon’s prohibiting the generic versions that were supposed to come out in 2006. I realize $234 a month is nothing compared to many HIV and cancer drugs. But $234 is a lot when you consider that my Narcolepsy prevents me from being able to work more than 15 hours/week (with medication) and that I am only 26 and will be dependent on drugs like Provigil for the rest of my life. I was barely scraping by with a $50/month copay so I suddenly found myself unable to front the costs to buy even a one-month supply of Provigil. I had to stop taking my medicine which meant I could no longer work at all.
Desperate to find a way to get my medicine so I wouldn’t end up on welfare, I called Cephalon’s PROVIGIL Assistance Program and requested financial assistance. I was still willing to pay part of the costs, but I hoped they could give me some sort of rebate. Cephalon told me that because I had some form of insurance I didn’t qualify for any assistance, regardless of how high my co-payment is or my financial situation. They told me that if I was uninsured they would pay up to $500 per month (which is the retail cost of a month supply for me). They actually suggested I drop my insurance plan. It seems strange (not to mention unethical) that they would rather I drop my insurance so they could give me $500/month instead of just helping me with a portion of my $235 co-pay. It is cheaper for them if I have insurance. And if they can afford to shell out $500 a month to every uninsured patient, why can’t they just reduce the price for everyone so less people will need their financial assistance in the first place? They would probably make more money if they charged less because patients like me wouldn’t be forced to stop taking the medicine all together.
I actually considered listening to them and dropping my insurance so I could get free medication, but that ultimately wasn’t an option because I have other health conditions and my pre-existing conditions would make it unlikely I could obtain new insurance in the future. I contacted NORD back in December to notify them of the discrepancy between Cephalon’s assistance policies and those implied on NORD’s website. I asked for their help or their clarification if I had misunderstood. 4 months later, I have yet to hear anything from NORD.
My neurologist was kind enough to give me samples which I now ration out for days when I absolutely must function. I can’t afford enough Provigil to work so I have been forced to apply for Social Security Disability Benefits (which I’m told will likely be denied). I’ve tried getting in on clinical trials but I don’t qualify. The thought of spending the rest of my life half-asleep and a burden to the people I love is so depressing I often think I’m better off dead.
Unethical drug companies have managed to take everything I’ve earned in my short 26 years of life and turn it into debt without any hope or means to get back on my feet. I don’t know about Genentech, but Cephalon certainly doesn’t care if their customers go without the product because of its cost. Cephalon has no interest in the well-being of the very consumers that support them.
We’re happy to post a response to this from Cephalon or NORD, if anyone from either of those entities cares to reply.
Yesterday we blogged here (“Why Drug Lawsuits are Necessary: FDA “isn’t capable of policing” drug safety, says Alaska Judge”) about Zyprexa lawsuits, particularly the state of Alaska’s (seeking to recoup the cost of treating Medicaid patients who took Zyprexa and whom Alaska alleges suffered diabetes and weight gain as a result) and the national class action in federal Court in New York, alleging that Eli Lilly (NYSE:LLY) illegally promoted Zyprexa for unapproved and unproven uses (so-called “off-label marketing.”)
Zyprexa’s success was due in large part to the enormous marketing campaign that Eli Lilly put behind it. Lilly’s pharmaceutical salespeople were the cornerstone of that effort. One former “sales rep,” Shahram Ahari, saw the error of his ways and now devotes his time to exposing the wrongs of pharmaceutical marketing and to supporting efforts to curtail that marketing.
Last night, he appeared on New England Cable News, talking about his experiences as a drug rep and what’s wrong with drug marketing:
Many readers may be familiar with Shahram as something of a YouTube celebrity for this clip as well:
PAL members AFSCME District Council 37 Health and Security Plan and New England Carpenters Benefits Fund filed a class action lawsuit against First Databank Inc. and McKesson Corporation (NYSE: MCK) in 2005, alleging that the two companies conspired to add an arbitrary 5% to Average Wholesale Prices of hundreds of prescriptions that were published in First Databank’s drug pricing guides. We’ve covered the case extensively on the PAL blog (archived posts here) and much more information about the case, including court documents, can be found on our website here.
In October 2006, we announced that First Databank had agreed to settle the case against them. McKesson Corporation, one of the three largest pharmaceutical wholesalers in the country, did not agree to settle, and has aggressively fought to get rid of the case ever since. McKesson, a company that is virtually unknown to consumers, is the 18th largest company on the Fortune 500 list, with over $88 Billion in annual gross revenues, with over $750 Million in 2007 profits. They are larger than numerous other corporations that are household words, including Procter & Gamble, AT&T, Boeing, Sears, Pfizer, Target, Dell and Dow Chemical.
Last week, Judge Patti B. Saris of the U.S. District Court for the District of Massachusetts, ordered that the case against McKesson can proceed as a national class action. She certified two national classes: (copy of the Order is here.
Consumer Co-Pay Class “The Court certifies the following class for a period beginning August 1, 2001 and ending on May 15, 2005 for all purposes:
Class 1, Consumer Purchasers: All individual persons who paid, or incurred a debt enforceable at the time of judgment in this case to pay, a percentage co-payment for the Marked Up Drugs during the Class Period based on AWP, pursuant to a plan, which in turn reimbursed the cost of brand-name pharmaceutical drugs based on AWP. The Marked Up Drugs include all of the drugs identified in Exhibit A to the Third Amended Complaint and consist of certain brand-name drugs only.”
Third Party Payor Class: “The Court also certifies the following class for a period beginning August 1, 2001 and ending on December 31, 2003 for the purpose of damages, and for a period beginning August 1, 2001 and ending on May 15, 2005 for purposes of liability and equitable relief:
Class 2, Third-Party Payors: All third-party payors (1) the pharmaceutical payments of which were based on AWP during the Class Period; (2) that made reimbursements for drugs based on an AWP that was marked up from 20 to 25% during the term of its contract with its PBM or with another entity involved in drug reimbursement; and (3) that used First DataBank or Medispan for determining the AWP of the marked up drugs. The Marked
Up Drugs are all drugs identified in Exhibit A and consist of brand-name drugs only.”
Hagens Berman Sobol Shapiro, the law firm that is lead plaintiffs counsel in the case, in its press release said that the case “could become the largest class action in the United States, potentially totaling $7 billion in damages for consumers and third-party payers.
The press release also said “damages on behalf of consumers could total from $200 to $800 million and damages on behalf of third-party payers will exceed $5 billion.”
The Judge’s certification of the case as a national class action is enormously important. It allows the case to proceed on behalf of millions of consumers and tens of thousands of health plans, union benefit funds, self-insured employers and other “third party payors.”
The case, and the facts that have come to light as a result, shines further light on the complete lack of accuracy and accountability in how drugs are priced and paid for in the United States. The Average Wholesale Price system handsomely rewards and virtually invites fraud, and is in dire need of replacement. This lawsuit has the potential to compensate the millions of consumers and health plans who were overcharged as a result of McKesson’s and First Databank’s alleged fraud.
Last week, the plaintiffs and First Databank also filed an Amendment Settlement with the Court, attempting to address concerns that Judge Saris raised at the January 2008 “final approval” hearing for the First Databank settlement. Copies of the revised settlement documents are available here. The Judge’s order certifying the classes can be found here.
To receive udpates about the McKesson case, the First databank settlement and other prescription drug pricing and marketing lawsuits and settlements, fill out the form located here.
For information about the settlement with First Databank and also with Medispan, Inc., go here.
The state of Alaska is suing Eli Lilly (NYSE:LLY) for failing to disclose health risks (like diabetes and weight gain) allegedly associated with Lilly’s hugely profitable “atypical antipsychotic” drug Zyprexa. Last week, attorneys for the state rested their case, at which point the lawyers for Eli Lilly asked the Judge to dismiss the case, saying that the matter was one for the Food and Drug Administration, and not for individual states.
The Judge disagreed, and refused to dismiss the case, offering an opinion from the bench as to the FDA’s ability to police drug safety. Here’s how the Anchorage Daily News described it:
Without lawsuits like the one the State of Alaska brought against Lilly, claims that drugs cause health problems “might well go unaddressed,” Anchorage Superior Court Judge Mark Rindner said from the bench this week.
The jury was out of the room. The state had just rested. Lilly asked the judge to issue an immediate verdict in its favor, a routine step at that point in a trial.
Rindner was reacting to an assertion by Lilly lawyer George Lehner that drug regulation is a matter for the federal Food and Drug Administration, not any state. Alaska’s Unfair Trade Practices and Consumer Protection Act shouldn’t apply to drugs, Lehner told the judge.
Rindner disagreed. Evidence presented by the state over the past two weeks established that the FDA “isn’t capable of policing this matter,” he said.
This isn’t the first time that a Judge addressing allegedly illegal Zyprexa marketing by Eli Lilly has dismissed the notion that the FDA was adequate to ensure that Zyprexa was safe and properly marketed. As we reported back in June 2007, U.S. District Court Judge Jack Weinstein, soundly rejected this notion in refusing to dismiss a class action lawsuit brought by consumers and health plans (including PAL coalition member Sergeants Benevolent Association Health and Welfare Fund. That case alleges that Eli Lilly illegally and improperly promoted Zyprexa for “off-label” uses, that is, uses that the FDA has not approved as safe and effective. In his ruling (available here), Judge Weinstein said:
“Under the present organization of the pharmaceutical industry, the official federal Food and Drug Administration (FDA), and the plaintiffs’ bar, the courts are arguably in the strongest position to effectively enforce appropriate standards protecting the public from fraudulent merchandising of drugs.” (Opinion, pp. 3-4)
And he went on…
“Allowing this and like suits to proceed may or may not increase the cost of pharmaceuticals and the efficacy of medical treatment in this country. It does, however, furnish backstop protection against under-regulated potentially dangerous activity by a market where caveat emptor largely rules.” (Opinion, p. 12)
What happens in the Alaska case will be closely watched, as 9 other states have similar lawsuits against Eli Lilly. A potentially incriminating email in which a Lilly vice president appears to advocate marketing Zyprexa for off-label purchases was revealed in the Alaska trial several weeks ago, the New York Times reported on March 14, 2008 (Lilly E-Mail Discussed Off-Label Drug Use). As Alex Berenson of the Times reported:
In the message, Dr. Lechleiter, who was then the company’s executive vice president for pharmaceutical products, noted to other Lilly officials that company representatives were already promoting Strattera, a second Lilly psychiatric drug, to pediatricians and child psychiatrists. The representatives could also discuss Zyprexa with such doctors, he said.
“The fact we are now talking to child psychs and peds and others about Strattera means that we must seize the opportunity to expand our work with Zyprexa in this same child-adolescent population,” Dr. Lechleiter wrote in the message. He also encouraged Lilly to get data on the use of Zyprexa in treating “disruptive kids” in order to increase the drug’s sales.
The Judge in the Alaska case refused to admit the email into evidence in the trial because that case does not concern off-label use. The email, however, is likely to be an issue in the off-label cases, such as the one before Judge Weinstein. In that case, Judge Weinstein will hear from both sides this week on a motion to certify the case as a national class action. These “class certification” motions are a vitally important stage in a class action case, as they determine whether or not the defendant (here, Eli Lilly) will face the claims of potentially millions of individuals and thousands of health plans.
These two Judges have acknowledged what by now is common knowledge: the FDA lacks both the resources (money, staff) and the political will to hold drug companies accountable and to force them to disclose safety risks associated with hugely profitable drugs. In the face of the FDA’s abdication of its core mission, the Courts are a vital safety net to ensure that drug companies cannot rip off and injure consumers with impunity. In the past few years, vital information about dangerous drugs has come to light only through litigation (for more on this, see “The Role of Litigation in Defining Drug Risks,” Journal of the American Medical Association, 2007; 297: 308-311)
To receive updates about the national Zyprexa class action that PAL members are involved in, as well as about other class actions concerning illegal marketing and pricing tactics by drug companies, fill out the form here. To learn more about the Zyprexa class action, go here.
The title of this post is one of the many questions that came to mind when I read yesterday’s New York Times story, Cutting Dosage of Costly Drug Spurs a Debate. The article describes the cost of Cerezyme, a drug made by Genzyme (GENZ). As the Times reports:
“The drug in question, Cerezyme, is used to treat a rare inherited enzyme deficiency called Gaucher disease. Some experts say that for most patients, as little as one-fourth the standard top dose would work, saving the health care system more than $200,000 a year per Gaucher patient.”
This raises many questions related to how we pay for very expensive drugs, particularly for rare diseases. Of course, one question is how much should a drug like Cerezyme cost? On the one hand, it’s understandable that a drug that is used by a very small group of patients is going to cost more. But at what point does “costing more” become “exploiting patients who have no other options?”
“With Cerezyme, which is made by Genzyme, the profits are sizable. Gaucher disease, which can have complications like ruined joints, is rare; only about 1,500 people in the United States are on the drug and about 5,000 worldwide. Sales of Cerezyme totaled $1.1 billion last year, making it a blockbuster by industry standards.”
Blockbuster drugs are typically taken by hundreds of thousands, and often millions of people. For a blockbuster drug to have a patient pool of just 1,500 people is incredible.
So how much should Cerezyme cost? Genentech says:
“The company says it needs the high price to make a sustainable business of serving such a small number of patients and to pay for research on new products. Genzyme also says it provides the drug free, if necessary, so that no one goes without the product because of its cost.”
Drug companies often try to play the “research & development card,” arguing that high prices are justified because it supports research into new drugs. But a recent study showed that drug companies still spend twice as much on marketing and administration as they do on researching and developing new drugs (”The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States,” PLoS Medicine, 1/3/2008).
Obviously, the amounts vary by company, and the study was of the industry as a whole, not particular companies. So it’s likely that Genzyme doesn’t spend twice as much on marketing as on R&D. Even so, the “R&D card” is a notoriously self-justifying but impossible-to-measure reason for high drug prices. How much is it fair to increase a drug’s price for alleged future R&D? At what point does a drug company sacrifice the financial well-being (and ability to afford the medication) of current patients on the altar of some uncertain and unknown set of future patients?
Then there’s the most interesting question:
What is the public entitled to when our tax dollars helped a drug get developed in the first place?
The article says:
“But critics say the company’s development costs were minimal, because the early work on the treatment was done by the National Institutes of Health, which gave Genzyme a contract to manufacture it. And analysts estimate the current cost of manufacturing the drug to be only about 10 percent of its price.”
There’s a federal law that’s at the heart of this question: The Bayh-Dole Act. This Act allows recipients of government research funding to retain the title to, and file a patent on, an invention that was discovered or created with that government funding. The Act was passed because it was felt that government-financed innovations that would benefit the public were sitting on the shelves at universities and research institutes, because the inventors could not patent and market those inventions.
But there’s a never-used provision of the Bayh-Dole Act that seeks to protect the public’s investment in such inventions, including drugs: The so-called “March-in Rights” (35 USC 203). This allows the government agency that gave the funding (in this case, the National Institutes of Health) the right to “march-in,” ignore the patent, and license the invention to, say, a generic drug maker, if doing so is “necessary to alleviate health or safety needs which are not reasonably satisfied” by the holder of the patent and if the patent holder is not making the invention “available to the public on reasonable terms” [35 USC 201(f)].
Does charging $300,000 a year for Cerezyme qualify? Or, for that matter, does anything? A consumer group, Essential Inventions, submitted two petitions to the NIH in 2004, asking them to “march in” and permit generic versions of two drugs, Xalatan (for glaucoma) and Norvir (an HIV/AIDS) drug, because the price being charged for those drugs was so high. The NIH denied both petitions, saying that “available to the public on reasonable terms” doesn’t mean at a price that the public can afford.
(In the case of Norvir, the manufacturer. Abbott Laboratories (ABT), had unilaterally quadrupled the price of the drug in December 2003. Members of Prescription Access Litigation sued Abbott over the price increase, alleging that it violated antitrust law. The lawsuit survived a motion to dismiss, was certified as a national class action, and is pending in the U.S. District Court for the District of Northern California. More info on that lawsuit is here.)
So the question remains, for a drug like Cerezyme, how high a price is too high? More importantly, if the price is too high, is there anything that we, the public, can do, especially when our taxes help discover the drug in the first place?
Which suggests that drug sales were lower in 2007 than in the past 47 years, right?
Wrong.
Drug sales did NOT decrease in 2007. In fact, far from it. According to the IMS Health report that the article describes, prescription drug sales grew by 3.8% in 2007.
So why the confusing headline? Because the IMS report says that the rate of growth slowed in 2007. In other words, sales grew, but not as fast as in past years – in 2006, sales grew by 8%.
“Growing but not as fast” is very different from “Declining,” yet all too often media reports conflate the two. A slowing growth rate may foretell a trend that might eventually turn into an actual decline, but that can’t be assumed.
That’s better but still confusing to the average reader.
What would be a better headline?
Here’s my suggestion: “Drug sales grew in 2007, but slower.”
Do you have one to propose? Post it in the comments.
By the way, we in the U.S. are now paying more than a quarter of a trillion dollars a year on prescription drugs – $286.5 billion a year, to be exact. Are we getting our money’s worth?
And in closing, why, according to IMS, did this slowdown-in-the-rate-of growth take place?
Loss of exclusivity – Branded drugs representing $17 billion in sales lost exclusivity in 2007, helping to drive prescription volume growth of 10 percent for unbranded generics. In 2007, generics continued to replace branded prescriptions in the major therapeutic classes, increasing their share of total dispensed prescriptions to 67.3 percent.
Uptake of new products – Uptake of new, innovative medicines represented just $441 million of total sales in 2007, reflecting both the fewest new product launches in the past three decades and slower adoption by physicians of these products.
Medicare Part D contribution – Prescriptions dispensed through the Medicare Part D program accounted for 19 percent of retail prescriptions at the end of last year, a modest increase over 2006, and reflective of a maturing program. Today, 65 percent of U.S. citizens age 65 and older are enrolled in the Medicare Part D program.
Safety issues – Sales growth in 2007 also was affected by a significant number of “black box” warnings and product withdrawals, as well as safety concerns raised by the FDA for products in the erythropoietins, diabetes and antidepressant therapy classes. Safety issues contributed to significantly lower- than-expected sales for products accounting for approximately 10 percent of the total prescription market.
A $125 million settlement has been announced in a major class action lawsuit involving members of the Prescription Access Litigation (PAL) coalition. The case, In re Pharmaceutical Industry Average Wholesale Price Litigation, was originally filed in 2002, and claimed that the defendant drug companies intentionally inflated reports of the Average Wholesale Prices (AWPs) on certain prescription drugs administered in doctors’ offices and paid for by Medicare Part B. The PAL member organizations that are plaintiffs in the lawsuit are:
Until 2006, the published AWP was used to set the price that Medicare and consumers making Medicare Part B co-payments pay physicians for these drug. Private insurance companies and other third-party payors also use the AWP to determine how much to pay physicians. The lawsuit contends that
consumers and third-party payors paid more than they should because of the drug companies’ false AWP reporting.
The settlement includes branded and generic drugs used primarily in the treatment of cancer, HIV and other serious illnesses. Under the terms of the settlement 82.5 percent of the settlement fund is designated for third-party payors’ claims and the remaining 17.5 percent is designated for consumer claims.
The defendants included in today’s settlement are:
Abbott Laboratories
Amgen Inc.
Aventis Pharmaceuticals Inc.
Hoechst Marion Roussel
Baxter Healthcare Corp.
Baxter International Inc.
Bayer Corporation
Dey, Inc.
Fujisawa Healthcare, Inc.
Fujisawa USA, Inc.
Immunex Corporation
Pharmacia Corporation
Pharmacia & Upjohn LLC
Sicor, Inc.
Gensia, Inc.
Gensia Sicor Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc.
ZLB Behring, L.L.C.
Drugs covered in this settlement include Aranesp, Epogen, Neupogen, Neulasta, Anzemet, Ferrlecit and Infed. A full list of the drugs covered by the settlement is available here.
Medicare Part B recipients, health plans and individuals who paid for these drugs but were not on Medicare will be eligible to receive payments from this settlement once the Court finally approves it. The following types of individuals and entities will be eligible:
Patients on Medicare Part B who paid a percentage (i.e. not a fixed copayment, but 10%, 20%, etc.) of the cost of one of the drugs in the case, taken between Jan. 1, 1991 and Jan. 1, 2005.
Health Plans and other Third Party Payors who paid all or part of a Medicare Part B recipient’s percentage co-insurance for one of the drugs.
Individuals not on Medicare Part B who paid all or part (a percentange) of the cost of one of the drugs taken between Jan 1, 1991 and March 1, 2008.
Health plans and other Third Party Payors who paid all or part of the cost of one of the drugs taken by an individual not on Medicare part B between Jan 1, 1991 and March 1, 2008.
The Court will hold a “preliminary approval” hearing this Friday. If the Court grants preliminary approval to the settlement, notices will be mailed to Medicare Part B recipients and Third Party Payors, and published online and in a variety of national publications. Class members will have the opportunity to file a claim form, object to the settlement, opt out of the settlement or file an appearance with the Court. The court will eventually hold a final hearing to approve all settlement details.
This settlement is the third one announced in this AWP litigation. Iin August 2006, GlaxoSmithKline (NYSE: GSK) agreed to a nationwide $70 million settlement and in May 2007 AstraZeneca agreed to a $24 million settlement to Medicare Part B Zoladex users nationwide. After a trial in late 2006 and early 2007, the court in November 2007 ordered AstraZeneca (NYSE: AZN) and Bristol-Myers Squibb (NYSE: BMS) to pay nearly $14 million to insurance companies and consumers in Massachusetts for the companies’ roles in unfair trade practices. Those companies are appealing that ruling.
The court is expected to set a trial date for remaining claims against AstraZeneca and BMS on behalf of insurance companies and consumers outside of Massachusetts.
The FDA Amendments Act of 2007, also known as FDAAA, as in “open wide and say FDAAA,” is a riveting 156-page read, and buried in its contents is a provision, known to its friends as 121 Stat. 890 Sec. 502(f)(1), that requires drugmakers to include a toll-free number in print advertisements for prescription drugs, for consumers to report adverse effects or negative side effects from those drugs.
(The FDA published a notice in the Federal Register on January 3, advising that the rule went into effect on January 1, 2008. Interestingly, although it says the rule goes into effect January 1, that doesn’t mean that all drug companies must comply with the rule by January 1 — the Federal Register notice says “In the preamble to the toll-free number proposed rule, the agency proposed that all manufacturers, dispensers and
pharmacies subject to the rule be in compliance not more than 1 year after the effective date of the final rule.” I guess only at the FDA does “in effect on Jan. 1, 2008″ really mean “in effect one year later than Congress required.”)
But what about TV ads? There’s no requirement that drugmakers include that toll-free number in their television ads. And no doubt drug companies wouldn’t want that requirement. Can you imagine a drug ad that said “Side effects may include bloat, foaming at the mouth, heart attack, hives, hallucinations, insomnia, excessive sleepiness, erections lasting longer than 4 hours, and compulsive gambling. Call 1-800-FDA-1088 if you experience any negative side effects while taking this drug.” That certainly would tend to, um, accentuate the negative, if you will.
But having these toll free numbers on TV ads is arguably far more important. It’s impossible to watch prime time TV without seeing several drugs an hour. People spend far more time watching TV than they do reading magazines. Drug companies spent twice as much on TV ads on Network and Cable TV in the first half of 2007 (nearly $1.6 billion) as they did on national magazines, sunday supplements and newspapers (just over $838 million). [Source: DTC Perspectives, "Spending Review," December 2007]
Bill Gates, the cofounder and chairman of the Microsoft, and cofounder and cochair of the Bill and Melinda Gates Foundation, recently spoke at the University of Chicago. A major focus of the Foundation, which is one of the largest in the world, is on international health and in particular on diseases striking people in the Third World that get scant attention from pharmaceutical companies.
He offered this insight into the skewed priorities of the pharmaceutical industry:
“Malaria kills 1 million people a year; baldness hasn’t killed anyone yet. Less than 10 percent of the money spent on curing baldness is spent on fighting malaria.”
Although, it’s worth noting that the Institute for One World Health, a nonprofit pharmaceutical company , just announced a partnership with Amyris Biotechnologies and sanofi aventis for the development of semisynthetic artemisinin, a key ingredient in first-line malaria treatments. The project has been ongoing since 2004, and was funded with a grant from the Bill and Melinda Gates Foundation.
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