Research and Marketing of Drugs: a Challenge-Part II
See Part I of this article: Prescription
Drugs and the Cost of Advertising Them-Part I
Also to see about the new proposal from the FDA about off-label
drug and medical equipment usage please see our article: The Food and Drug Administration-FDA .
(5/27/08)- Merck & Co. agreed to pay $58 million to settle civil claims by 29 states and the District of Columbia that it had used deceptive advertising for its painkilling medication Vioxx that it withdrew from the market in September 2004.
The company also agreed to a ban on medical ghostwriting, under which an author's true identity is concealed. Under the terms of the agreement the company will submit all new television commercials for its drugs to the FDA for review for the next seven years. The company will abide by any and all changes that the agency calls for in its review of the material.
Merck will also delay television ads for newly approved pain medications for the next ten years.
This civil settlement ends any investigations into Vioxx advertising practices by the company by these 29 states and the District of Columbia.
(5/22/08)- In an op-ed article in the May 14th edition of The New England Journal of Medicine, the 2 authors chastised Johnson & Johnson, and its subsidiary Cordis for what they allege is the company's misleading "Life Wide Open" direct-to-consumer television ad for its stent Cypher.
The 60-second ad for the stent failed to adequately warn consumers associated with the implantation of stents. The article was written by the cardiologists Dr. William E. Boden of the medical school at the State University of New York at Buffalo and Dr. George A. Diamond of Cedars-Sinai Medical Center in Los Angeles. As we point out in our item dated 5/16/08 below a subcommittee of the House Energy and Commerce Committee has recently held hearings regarding direct-to-consumer ads.
Print prescription drug ads already require that a toll-free number to the FDA, to report adverse reactions, be included in the ad, but television ads do not have such a requirement. There is no such requirement for ads for medical devices.
The FDA has had a set of guidelines since 2004 for advertising regulations for medical devices, but so far, no action has evolved into regulations for any of these proposals. The Cypher ad was the first one to market stents directly-to-consumers. TNS Media Intelligence estimates that medical device manufacturers spent about $200 million on television ads for their products in 2007
A spokesman for the company, Christopher Allman, said the television ad is no longer running nationally but is still being broadcast in the Baltimore area.
The ad in question gives the impression that the Cypher stent is going to improve life more than any other brand would.
In the article the authors state, "The notion that television viewers inspired by such an ad would go to their physicians and request not only a stent, but a specific brand and model of stent is frightening if not utterly absurd."
(5/16/08)- A subcommittee of the House Energy and Commerce Committee, headed by Michigan Democrat Representative Bart Stupak, has held a hearing in connection with the topic of direct-to-consumer advertising by the drug industry. Mr. Stupak said that he wants to lay the groundwork for future legislation to tighten controls on drug marketing, including giving the FDA the right to force changes in TV drug ads before they are broadcast.
In an recent interview Mr. Stupak cited the advertising by Johnson & Johnson and its subsidiary Ortho Biotech for Procrit as an anti-fatigue drug, a use for which the drug wasn't approved, despite repeated requests from the FDA to the companies to revise their commercials. "They advertised this for seven years," said Mr. Stupak, calling this a violation of off-label-use prohibitions.
The company stopped running the Procrit TV ads in 2005, and the print ads in 2006, even thought the agency first requested stoppage of the ads in 1999.
(4/26/08)- Pharmaceutical companies spent about $5.4 billion on TV ads last year, according to Nielsen Monitor-Plus. The chairman of the House Committee on Energy and Commerce, Michigan Democrat John Dingell, plans to announce a hearing on direct-to-consumer advertising, to take place in a few weeks.
Senator Chuck Grassley of Iowa, the ranking Republican on the Finance Committee, and Representative Henry Waxman, the California Democrat who is chairman of the Oversight and Government Reform Committee, are both investigating drug marketing.
A recent edition of The Journal of the American Medical Association (JAMA) has cast additional doubt on the pending proposal from the FDA to allow drug companies to advertise off-label usage of a drug if the usage was approved in a peer-reviewed medical journal.
The JAMA paper asserted that Merck & Co. had drafted research studies for its pain-killing medication Vioxx, which had to be withdrawn from the market in 2006. It seems as if the company had prepared these off-label studies and then lined up prestigious doctors to put their names on the report before publication.
The article was based on documents found in the Vioxx litigation, one of which showed that a study required an "external author".
Pharmaceutical companies have previously been allowed to distribute reprints of articles supporting off-label uses, but only with FDA permission, and only if they were also formally seeking approval of those uses.
The new proposal requires that the articles published in peer-review journals not be misleading, and have to contain a warning that the FDA has not approved the off-label usage. The new proposals include a requirement that drug marketers ads must contain a phone number that consumers can call to make complaints to the FDA.
(4/5/08)- Eli Lilly & Co. and the state of Alaska announced a settlement of the lawsuit brought by the state in connection with Lilly's anti-anxiety drug Zyprexa. The trial had been going on for 3 weeks, and the settlement was announced at $15 million, even though the state's claim on behalf of its Medicaid expenditures was for $200 million.
Lilly has reached a $1.2 billion settlement with 31,000 plaintiffs in connection with Zyprexia lawsuits. As we note in our item dated 2/5/08 below, the company is close to a settlement with U.S Attorney in the case against the company now pending in the Eastern District of Pennsylvania that is expected to cost the company about $1 billion.
The company still faces nine cases filed by other state attorneys general, 1,600 by individual plaintiffs, and others by shareholders and third-party payers such as insurers.
Plaintiffs allege that the company pushed the drug for unapproved purposes, failed to discloses information about Zyprexia's link to weight gain and diabetes, and failed to report important information that it had in its hands without revealing same to the FDA before it approved the drug.
A clause built into the settlement would require the company to pay Alaska more per capita if any other state gets a better deal. There were approximately 200,000 prescriptions written for the drug on which the state based its claim.
Alaska Assistant Attorney General Ed Sniffen said the state took the settlement because damages would be difficult to prove, and the certainty that the company would appeal the decision.
Clouding the issue in the case is the doctrine of "pre-emption", wherein the Supreme Court recently decided a case involving a medical device wherein the 8-1 majority ruled that the approval by the FDA precludes a lawsuit on the state basis in the absence of fraud in getting that approval.
The Supreme Court is expected to decide a case in October between Wyeth v. Levine in which this doctrine of "pre-emption" is also involved..
One-third of Americans have asked their doctors about a medicine they have seen advertised and 82% of these people received a prescription from their doctors, a new survey by USA TODAY (March 4, 2008), the Kaiser Family Foundation and the Harvard School of Public Health found. About 44% of participants said their doctors prescribed the drug they asked about, while more than 50% said the doctor prescribed a different drug.
(3/5/08)- Pfizer Inc., has decided to cancel its long running Lipitor ad campaign that featured Robert Jarvik as a spokesman. For more on this matter please see our item dated 2/20/08 below. That's very nice of the company to cancel the 2- year ad campaign just when the contract with Mr. Jarvik was due to expire anyway.
"The way in which we presented Dr. Jarvik in these ads has, unfortunately, led to misimpression's and distractions from our primary goal of encouraging patient and physician dialogue on the leading cause of death in the world-cardiovascular disease, " said Ian Read, Pfizer's president of worldwide pharmaceutical operations. "We regret this. Going forward, we commit to ensuring there is greater clarity in our advertising regarding the presentation of spokespeople."
The House Energy and Commerce Committee that has been looking into the Jarvik television ads will continue with its hearings on this matter.
Incidentally, three former colleagues of Dr. Jarvik at the University of Utah sent a letter to Pfizer complaining that the ads incorrectly identified Dr. Jarvik as the "inventor or the artificial heart". The three assert that it was his mentor at the university Dr. Willem J. Koff, and his associate there, Dr. Tetsuzo Akutsu who deserve that distinction.
(2/20/08)- Direct-to-consumer (DTC) drug advertising first became legal in 1997. According to the latest figure, the cost of DTC advertising has just about tripled from 1997 to 2007 when it reached about $4.8 billion. Pfizer Inc., spent $258 million from January 2006 to September 2007 advertising its best selling cholesterol drug Lipitor according to figures from TNS Media Intelligence. Total worldwide sales of $12.7 billion of Lipitor in 2007 fell off slightly from the prior year, because a generic version of Merck's Zocor became available for the first time.
Not only is the cost of the DTC advertising helping to drive up the cost of prescription drugs, but all to often this advertising is shown to be false and misleading. The latest example of this that has come into the limelight is the usage by Pfizer of Dr. Robert Jarvik, who is best known for the invention of his artificial hear more than 25 years ago.
The House Committee on Energy and Commerce is looking into the Pfizer-Lipitor-Jarvik ad campaign to see if it violated legal and ethical questions in regards to DTC advertising. The committee released a copy of the 2-year contract between the doctor and the company in which he was paid a minimum of $1,350,000 to promote the drug.
The two-year deal began in March 2006 with a commercial in which Dr. Jarvik was shown as sculling at Lake Crescent near Port Angeles, Washingotn. In a newsletter published by the Lake Washington Rowing Club in Seattle it turns out that a member of the club, the sculler in the ad, was actually Dennis Williams who was similar to Dr. Jarvik in build and with a receding hairline.
Dr. Jarvik said he would not comment on the matter. Even though Dr. Jarvik holds a medical degree, he is not a cardiologist and is not licensed to practice medicine. The ad in question ran from March through July 2006.
The House committee is also seeking records from the following ad agencies involved in the project: IMC2; the Maya Group; cline, Davis & Mann; ARS Group; Guideline; Ipsos-ASI; Ipsos-Understanding; the Kaplan Thaler Group and Unit 7.
(2/6/08)- Eli Lilly & Co. may have the dubious distinction of being the new record holder with the largest settlement with the Justice Department for misleading advertising and off-label usage of one of its drugs. The drug in question is Zyprexia, an anti psychotic medication, that according to the latest media reports the company is negotiating with the federal prosecutor in the Eastern District of Pennsylvania to settle for over $1 billion.
Prior Justice Department investigations have resulted in settlements of $875 million with TAP Pharmaceuticals in 2001, and $355 million with AstraZeneca in 2003. The U.S. Attorney's Office for the District of Massachusetts health-care-fraud unit is investigating whether Merck &Co. promoted its pain medication Vioxx, which it voluntarily withdrew from the market in September 2004, for off-label usage.
Merck disclosed in a regulatory filing in February 2007 that the Justice Department had issued a subpoena requesting information relating to the company's research, marketing and sales of Vioxx as part of a federal investigation under criminal statutes. The filing went on to state that 31 state attorney generals and the District of Columbia are investigating the company in connection with Vioxx sales and marketing practices.
Documents from Lilly show that from 2000 to 2003 the company encouraged doctors to prescribe Zyprexa to people with age-related dementia, as well as people with mild bipolar disorder who had previously had a diagnosis of depression. The drug has only been approved by the FDA to treat people with schizophrenia or severe bipolar disorder.
It is thought that in addition to the fine, Lilly may plead guilty to a misdemeanor charge as part of the agreement. If the company pleads guilty to a misdemeanor, rather than a felony charge it could continue to sell Zyprexa to both Medicare and Medicaid clients.
The Lilly fine would be distributed among federal and state governments, which spent about $1.5 billion on Zypexa last year. The fine would be in addition to $1.2 billion that Lilly has already paid to settle 30,000 lawsuits from people who claim that the drug caused them to develop diabetes or other diseases. Zyprexa can cause severe weight gain in many patients and has been linked to diabetes by the American Diabetes Association.
Federal prosecutors in Philadelphia are leading the settlement talks along with Justice Department officials in Washington. State attorney generals offices are also involved. Lawyers at Pepper, Hamilton, a firm based in Philadelphia, and Sidley Austin, a firm based in Chicago, are negotiating for Lilly.
Lilly presently faces a civil trial in Anchorage by the state of Alaska to recover money the state spent on Zyprexa prescriptions. Incidentally, Lilly has raised the price of the drug by about 40% since 2003.
Federal prosecutors have been investigating the company since 2004, and state attorneys general have been doing so since 2005. The investigations gained impetus when the N.Y. Times published articles describing the company's efforts to play down Zyprexa's negative side effects and to promote the drug for off-label usage.
Internal Lilly marketing documents and e-mail messages showed that the company wanted to persuade doctors to prescribe the drug for patients with age-related dementia or relatively mild bipolar disorder.
(1/26/08)- The ramifications of the Vytorin/Zetia controversy that we discussed in our item dated 1/22/08 in our item in the article Beta-Blockers, ACE Inhibitors & Statins in the Battle Against Heart Disease or Heart Failure-Part II continue to swirl and expand, so that now an issue of conflict of interest has now entered into the plot. The Enhance end-point study of Vytorin, which is made as a joint venture between Merck & Co. and Schering-Plough determined that it was no better than the statin drug Zocor (also made by Merck) working alone at reducing arterial plaque.
The issue that initially caused consternation was the delayed release of the results of the study.
On January 15th, the day after the results of the study was released, the American Heart Association came out with a statement saying that the announced result was too limited to draw conclusions about Vytorin's ability to reduce heart attacks or deaths compared to Zocor alone. The association advised patients to consult with their physicians before discontinuing usage of the drug.
At no time did the association reveal that it receives nearly $2 million a year from the joint venture
Merck and Schering-Plough have suspended all television ads for Vytorin and Zetia, but print ads, defending the drug have been appearing as full page ads in newspapers such as the NY Times and the Wall St. Journal. .
Total U.S. prescriptions written for Vytorin in the week ended January 18th fell about 9.5% to 359,659 from 397,533 in the week ended January 11th, according to Verispan, a Yardley, Pa., drug-data firm. Prescriptions for Zetia, which the Merck/Schering-Plough joint venture also markets, fell 12% to 258,619 from 294,405 the week before according to Verispan.
(12/11/07)- The Johnson & Johnson subsidiary Cordis Corporation has begun an expensive direct-to-consumer advertising program as it became the first company to advertise its Cypher drug-coated stent to the public. The other approved drug-coated stent on the market is Boston Scientific's Taxus stent.
Both Medtronic's Endeavor drug-coated stent and Abbott's Xience V drug-coated stent are expected to gain FDA approval, and be marketed starting in 2008. Both of these stents are now being sold in Europe. For more on this matter please see our article Medical Devices-Drug Eluting Stents Boston Scientific will team up with Abbott to market the stent under the brand name of Promus.
The Cordis advertising campaign will be marketed on TV through a 60-second spot titled "Life Wide Open", which will be shown on 175 spots throughout the the life of the program. The company has also set up a Web site at cypherusa.com as an online marketing destination and information clearinghouse for patients and doctors. Omnicon Group's agency BBDO developed the consumer elements of the spot.
The campaign is aimed at showing the lasting relief afforded by the Cordis' Cypher stent from chest pains and shortness of breath which are the main symptoms of clogged coronary arteries, or angina. The television spot goes on to state that Cypher is the most studied and widely used of all stents on the market today.
Many doctors and medical professionals have been complaining that the insertion of stents is widely overused as is. Now with the advent of this advertising campaign some experts like Dr. Willian Boden, a professor of medicine at the State University of New York at Buffalo said "It's deplorable," and "You've got to wonder whether it's a sign of desperation."
Drug companies spent about $5.3 billion on advertising in 2006, which means that this figure has more than doubled since 2001. According to figures from the Center for Public Integrity the drug companies spent $155 million on lobbying from January 2005 to June 2006 on "a variety of issues ranging from protecitng lucrative drug patents to keeping lower-priced Canadian drugs from being imported."
Seven of the top 10 drug launches in 2006 were for generic drugs.
(11/14/07)- Cephalon Inc. became the latest drug or biotech company to settle a federal investigation into its sales and marketing practices by paying a huge fine. The company also agreed to enter a corporate integrity agreement while pleading guilty to a misdemeanor charge for violation of federal prescription drug laws. In this case the amount of the fine is $425 million, and follows an investigation of Medicaid claims by the United Stated attorney in Philadelphia.
The company, maker of the sleep-disorder drug Provigil was sued by the Pennsylvania Turnpike Commission in May over claims that the company sought to monopolize the drug market by delaying generic competition.
The agreement does not preclude state and municipal suits against the company for the same practices.
(11/5/07)- Merck & Co.'s cholesterol lowering statin drug Zocor patent expired, so that a generic version of the drug, simvastatin became available. The patent for Pfizer's Lipitor, which is the best selling drug in the world with over $14 billion in sales last year, does not expire until March 2010. It is estimated that total statin drug sales totaled over $33 billion last year.
Whereas 18 months ago Lipitor captured 40% of the sales for cholesterol lowering medication, it now is down to 30% of the market. Lipitor costs between $2.50 to $3 per day, whereas simvastatin costs between 75cents to $1 per day at most retail pharmacies.
Pfizer has indicated that it will try its utmost to keep the sales numbers for Lipitor as high as it can while the drug remains under patent protection. So far the company has spent 50% more this year advertising the drug than it did last year, when its Lipitor ad spending totaled $142.7 million.
Kpfizer has been running a broad based print and broadcast advertising campaign featuring Dr. Robert Jarvik the inventor of the artificial heart, endorsing Lipitor.
"There's a common misconception that all cholesterol lowering medications are the same. They're not. There is no generic version of Lipitior."
Pfizer is also sponsoring a speaking tour by Dr. Louis W. Sullivan, a former secretary of Health and Human Services, who without citing Lipitor specifically is arguing against insurer's efforts to influence medical decisions.
(10/16/07)- Bristol-Myers Squibb Co. announced that the settlement terms with the U.S. attorney's office in Massachusetts had been finalized, and that it had agreed to pay slightly over $515 million to resolve the matter. The settlement of the charges had first been announced in December 2006.
The agreement settles federal and state investigations into the company's marketing and pricing practices. Included in the settlement that resolved the matters were the government's allegation as to illegal remuneration from 2000 to 2003 in the form of consulting fee to induce doctors and other health-care professionals to buy the company's drugs.
The government had further alleged that the company set and maintained fraudulent and inflated prices for an assortment of oncology and generic drug products, and knowingly misreported pricing of the antidepressant Serzone. It was also alleged that between 2002 and 2005, the company promoted the sale of Abilify, an anti-psychotic drug for pediatric use and to treat dementia-related psychoses. The FDA approved neither drug's usage for treatment of those illnesses.
(10/5/07)- Congress has just passed a bill re-authorizing the financing of the FDA that was due to expire in September. For more on this topic please see our article on the Federal Drug Administration. Some of the provisions in the new law regulate the ability of the drug companies and their ads.
The FDA will get new power to require drug companies to submit TV ads for review before they run, but it can only recommend changes, not require them. The bill lets the agency levy fines for false and misleading ads. The fines will amount to $250,000 for the first violation in any three-year period, and won't go above $500,000 for any subsequent violation in a three-year period.
Television and radio ads will also have to include " clear, conspicuous and neutral" statements about any side effects.
The pharmaceutical industry was the 10th biggest advertiser in 2006, spending $5.3 billion, or 3.5% of the total $149.6 billion U.S. market. The industry registered the highest growth rate among the top 10 U.S advertisers, growing 13.8% to $5.3 billion from $4.6 billion in 2006.
(8/25/07)- The FDA announced that it planned to study how about 2,000 people react to TV drug ads to determine if they are truly aware of the negative side effects of the drugs being advertised in such a pleasant setting. The audio warnings are almost a second thought in the ads, which normally give a pleasant picture of the subjects in the ad.
The results of a recent study that appeared in the New England Journal of Medicine suggested that the agency's drug-ad-enforcement activity had been sorely lacking. Critics of the drug company TV ads charge that images of smiling and relaxed couples and families far overshadow any negative audio comments that may appear in the drug ads.
(7/23/07)- Orphan Medical, a subsidiary of Jazz Pharmaceutical pleaded guilty in federal court in Brooklyn, to felony charges of improperly promoting its narcolepsy drug Xyrem for unapproved uses. The company agreed to pay $20 million in fines and restitution to the federal government and private insurers.
Jazz will also cooperate with the government's continuing criminal investigation and will never promote Xyrem for uses other than those approved by the FDA. The drug is the prescription version of the street drug gamma hydroxybutyrate, which has been associated with date rape and serious risks of overdose, resulting in coma and death.
The Drug Enforcement Administration lists the street version as a Schedule I drug, the most dangerous kind, the same category as heroin. The drug was approved by the FDA for narcolepsy, a serious sleep disorder. It was alleged that Orphan promoted the drug for other uses, including depression, insomnia and fibromyalgia, a pain disorder.
The investigation began after Shelley Lauterbach, a former saleswoman for Orphan, filed a whistle-blower lawsuit in 2005 in the Federal District Court in Brooklyn. Ms. Lauterbach will share a part of the $20 million settlement.
(5/18/07)- Documents supplied to, and examined by the Wall Street Journal shed some light on the murky world of illegal drug rebates, and the pushing of unapproved dosages of the drug Procrit by Johnson & Johnson. This is the drug along with Amgen's Aranesp (EPO) that are blockbuster drugs used to treat anemia patients who are undergoing chemotherapy. The FDA has recently required both companies to put label restrictions on their drugs as to the safety of the dosage that doctors may use when administering the medication.
Both former salesman of Procrit no longer work for J&J, and have brought whistle blowers suits against the company for the illegal selling of the drug.
Dean McClellan, worked for 12 years at J&J's Ortho Biotech unit selling Procrit, and Mark Duxbury was a star salesman for the drug who was fired by the company in 1998. Mr. McClellan saved 15,000 pages of memos from the company that he turned over to the Journal for review. The suit was filed in the Federal District Court in Boston.
Procrit is an infused drug, which is administered in a doctor's office. Among the charges alleged in the lawsuit are that J&J made offers to allow buyers of Procrit to receive discounts off an already discounted price for the drugs as well as rebates so that they would not use the Amgen product.
Another J&J program offered hospitals incentives to buy Procrit and shun Aranesp since they would receive an extra discount on other J&J drugs that they purchased if Procrit was used at least 75% of the time instead of Aranesp.
In addition J&J started a "Right of First Refusal" contract for doctors by offering Procrit at a lower price than what Amgen was offering to sell Aranesp at. Mr. McClellan also alleges that J&J used promotional material to encourage doctors to prescribe Procrit at higher dosages than was approved by the FDA.
(4/21/07)- The Senate Health Committee approved legislation that would give the FDA the power to prohibit direct-to-consumer advertising for up to two years for a new drug. The legislation would authorize the agency to restrict the advertising if the FDA determines that disclosure of serious risks associated with the new medication were not enough to fully protect the public from the adverse reactions.
Some legislators expressed their doubts as to the legality of this type of provision, as a violation of free speech, but supporters of the proposed legislation cited the fact that it was prefaced by the phrase: "To the extent consistent with the Constitution…".
The proposed legislation would also allow the agency to charge a user fee to drug companies voluntarily submitting ads to the FDA for review before being aired.
The legislation also codifies a tool that the FDA has begun to use as part of the drug approval process to minimize the risk that a product will cause harm in the marketplace while its effects on the broader population are monitored.
These so-called risk evaluation and mitigation strategies (REMS).are one of the most controversial parts of the legislation.
(3/15/07)- Johnson & Johnson announced that it had received subpoenas from federal prosecutors in Philadelphia, Boston and San Francisco related to the sales and marketing of 3 of its drugs. The drugs in question are Risperdal, a treatment for schizophrenia and bipolar mania; Topamax, an epilepsy drug; and Natrecor, which is used to treat heart-failure patients.
All three investigations have been previously disclosed, but these new subpoenas indicate that the matter is far from being resolved.
On March 1, the House Committee of Oversight and Government Reform sent letters to 5 drug and medical device companies as part of an initial investigation into the promotion of the products beyond the uses approved by the FDA. Johnson was one of the 5 companies that received the letter.
A report from the Taxpayers Against Fraud Education Fund fount that, as of last August, more than 180 fraud allegations against drug companies were pending with the Justice Department, up from 150 in 2005
(2/4/07)- Direct-to-consumer drug advertising rose sharply between 1997 at $1.1billion, when it was first allowed, through 2005 when it was at the $4.2 billion mark according to the GAO. It dropped off somewhat in 2005, mainly because of Merck's dropping of advertising for Vioxx. TNS Media Intelligence, an advertising consulting firm, estimated that it rose 8.4% to $3.29 in the first 9 months of 2006 which brings it on track to come in with $4.5 billion in spending for the year.
The industry recently set up voluntary guidelines before beginning ads for new drugs, but each drug company has its own interpretation of what an "appropriate" time is before beginning to advertise their new drugs. A TNS study showed that on average, the companies are waiting 15 months before introducing ads for their new drugs.
The FDA sent 15 warning letters to drug companies regarding ads in 2005, and a total of 22 companies received warning letters in 2006. Under a bill sponsored by Senators Edward M. Kennedy and Michael Enzi, the chairman and ranking Republican on the Senate Health, Labor, Education and Pensions Committee, the FDA would be granted the power to require moratoriums on new drug advertising.
(1/15/07)- The FDA and the pharmaceutical industry have reached an agreement on the schedule for the new user fees that we discussed below in the item on 12/2/06. Congress must approve the five-year deal before it can take effect, so there probably will be some major changes before it is enacted. The FDA will start to hold public hearings on the new fee schedule next month.
Under the plan, companies would pay the FDA a one-time fee on top of charges for each television ad submitted for review totaling $6.25 million in fiscal year 2008. The deal accompanies proposed legislation to renew other industry funding for FDA drug reviews through 2012. It includes about $392.8 million in fees for fiscal year 2008, but the charges for the following years were not immediately clear.
About $29.3 million of those fees would target the agency's drug safety system. The 2008 fees include an additional $4 million for technology that would eventually allow drug manufacturers to submit products electronically.
This is the process that has been in place since 1992, and there are many that question the wisdom of the FDA being funded in part by the industry that it oversees. The ad fees would allow for 27 additional staff reviewers who would evaluate the ads within 45 days.
(12/29/06)- Bristol-Myers Squibb and the U.S. Attorney's office in Boston have reached a tentative agreement in which the company will pay $499 million to settle a federal investigation into illegal sales and marketing activities from the late 1990s through 2005. The investigation was first started in 2003, when the attorney's office subpoenaed the records of the company.
Although it is not exactly known which drugs were involved in the action, it is believed that Abilify, the anti-psychotic drug, which is the company's best selling drug is believed to be covered under the investigation.
As in the previously negotiated settlements between the Justice Department and companies such as GlaxoSmithKline, Schering Plough, and TAP Pharmaceuticals, it is also expected that Bristol will sign a corporate integrity agreement with regulators in the Health and Human Services Department who monitor industry compliance with federal insurance programs.
These agreements usually require the companies to run employee training programs, set up hot lines to report rule violations and follow other practices listed in government compliance guidelines. They generally run for 5 years and often require the company to hire an independent auditor of compliance practices.
(12/22/06)- If you want to talk about being beleaguered, how the FDA has only 6 reviewers to screen, review and track the more than 10,000 pharmaceutical ads placed in the media each year.
In a recent report that was issued by the Government Accountability Office the auditors found that between 2002 and 2005, it took the FDA four months on average to draft, approve and send warning letters and other correspondence to companies that were in violation of advertising rules. Between 1997 and 2001, which was before FDA lawyers began reviewing the letters as a matter of policy, it took two weeks on average to issue the letters. The number of letters written fell off by about half between the two time periods.
According to the report about $4.2 billion was spent by the pharmaceutical industry on advertising in 2005.
(12/2/06)- The Food and Drug Administration has reached an agreement with the pharmaceutical industry that would require the industry to pay fees to the agency to check the ads, in return for speedier reviews. The new proposed fees would be used to help pay for new staff to be hired by the FDA to review the industry's TV ads.
This proposed agreement would be submitted in addition to a new 5-year pact setting new user fees to be paid by drug makers to the FDA when the agency reviews their applications to market new drugs.
There are many concerned public advocates who condemn a system wherein an industry that is subject to regulations pays the fees that support that agency. To the best of our knowledge that is not the case for any other agency of the federal government that regulates an industry.
The agreement is not finalized yet and must be approved by the parent of the FDA, the Department of Health and Human Services. If there is an agreement reached, the U.S. Congress must approve it before it can take effect. Both of the agreements would begin in the government's fiscal year 2008, which starts on Oct.1, 2007.
The proposed agreements have resulted from months of negotiations between the agency and two trade organizations that represent the pharmaceutical industry, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnical Industry Organization (BIO).
The FDA is expected to get more than $300 million in user fees in fiscal 2007, the last year of the current agreement. If the proposed agreement is approved that amount would increase by about one-third in 2008.
The FDA agreed that it would give drug makers a projected time frame of about 2 1/2 months to review new-drug applications after receiving the application.
The proposed agreement on TV ads would involve a complicated formula under which drug companies would pay about $40,000 to $50,000 at the beginning of each year for each TV ad campaign they planned to air that year. The companies would pay more -double the normal fee- in the first year to create a reserve fund. In return, the agency would phase in a requirement that any TV ads must be reviewed within 45 days.
Part of the money from the fees would go towards helping pay for the agency's move to a new office building in White Oaks, Md.
(11/4/06)- GlaxoSmithKline PLC has agreed to pay $63.8 million to settle a class action lawsuit's claim that it promoted its antidepressant drug Paxil for use by children while withholding negative information about the medication's safety and effectiveness.
Members of the class, including all U.S. residents who bought Paxil and Paxil CR, a controlled release version of the drug, for their children each could get full refunds if they have receipts for their purchases. Anyone without a receipt can get $15.
An Illinois judge will hold a hearing March 9, 2007 on whether the settlement is fair. Attorneys for the plaintiffs could get about $16.6 million.
(9/27/06)- There has been a great deal of talk about amending the 1997 law that allowed direct-to-consumer advertising by the drug companies. Now a long anticipated report from the Institute of Medicine, which is part of the National Academy of Sciences adds to the clamor calling for changes in drug advertising.
The Institute of Medicine is a non-profit organization created by Congress to advise the federal government on health issues. The report was issued by the Committee on the Assessment of the United States Drug Safety System, led by Sheila P. Burke, deputy secretary and chief operating officer of the Smithsonian Institution.
The FDA is torn between two conflicting viewpoints- on the one hand is a group that states that we need to speed up the drug approval process, while on the other hand is the group that says safety first and speed second.
The pharmaceutical industry provides much of the financing for the FDA under a law that was enacted in 1992. That law is due to expire next year, and the battle lines are already being drawn in connection with its renewal. There are many who feel that an industry should not be the one who finances an agency that oversees that same industry that is providing the financing.
There is little chance that the Congress will act on any of the proposals before next year, when it must re-authorize the 1992 financing deal.
The following are the highlights of the recommendations from the report:
(9/10/06)- Schering-Plough Corp.of Kenilworth, N.J., agreed to pay a total of $435 million, and a unit of the company agreed to plead guilty to criminal charges to settle a federal allegation of fraudulent drug marketing and pricing.
The guilty plea from the unit, Schering Sales means it can no longer sell drugs to the government, but its marketing functions have been taken over by other parts of the company, which can continue to do business with the government. Schering sales will also pay a criminal fine of $180 million.
The government accused the company of illegally inducing doctors to prescribe a number of drugs, including the cancer medications Temodar and Intron A, K-Dur, and several hepatitis medications.
The agreement comes two years after Schering agreed to pay a $340 million fine in connection with charges against it, that were brought by the Philadelphia U.S. Attorney's office. Schering was charged with having paid a kickback to a health insurer to protect its share of the market for its allergy drug Claritin, and thus avoided charging Medicaid and Medicare with the lowest price as the law requires.
The FDA approved the drug Temodar in 1999 only to treat anaplastic astrocytoma, a type of brain tumor, in patients who did not respond to other drug regimens. The Boston U.S. Attorney, Michael Sullivan charged that the company promoted the drug to treat several other types of brain cancer, and cancer that had spread to the brain from elsewhere.
Mr. Sullivan said the Schering had also provided misleading information to the government abut the price it was charging a health maintenance organization for Claritin RediTabs, to avoid having to pay rebates to the Medicaid program.
(6/18/06)- The American Medical Association adopted a compromise proposal, at its annual meeting in Chicago that would allow the FDA and manufacturers of new prescription drugs and implantable medical devices to work out a waiting period for each product before allowing ads. This waiting period will allow the medical profession more time to study the products and how they should be advertised.
The new stance from the AMA is in line with guidelines that the pharmaceutical industry adopted last year when it pledged to educate doctors before beginning ad campaigns. The association's new president-elect, Dr. Ronal M. Davis, said the measure would let doctors review the pros and cons of these products before prescribing them.
"The length of time this requires will vary from medicine to medicine, and companies will likely meet this goal in different ways", said Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA).
At previous AMA meetings, the group had considered a ban on prescription drugs ads, saying that the ads only induced patients to request drugs that they did not need from their physicians.
(4/15/06)- A lawsuit has been filed in the federal court in Newark, NJ, by a New Jersey employee-insurance fund alleging that Pfizer Inc. had defrauded state and federal Medicaid programs and private insurers by marketing Lipitor to a broader population of patients than permitted under federal rules.
The suit alleges the company illegally sought to persuade doctors to prescribe an expensive, lifelong drug regimen to patients with only low to moderate heart disease risk, in violation of its federally approved labeling rules. Lipitor is the most widely sold drug in the world, with over $12.1 billion in worldwide sales last year.
Federal guidelines call for exercise, diet and weight loss not drugs, for people with low to moderate risk of heart problems. The suit also alleges that a 2004 Pfizer securities filing "blatantly promotes Lipitor off-label use as a business opportunity for Pfizer."
(3/31/06)- Johnson & Johnson revealed in its most recent 10-K filing with the SEC that its Janssen Pharmaceutica subsidiary received a civil-investigative demand concerning Risperdal in January from the Texas attorney general. He is seeking "broad categories of documents related to sales and marketing of Risperdal," the filing said.
Risperdal Consta, which is used in the treatment of schizophrenia, was the company's biggest selling drug in 2005 with total sales of $3.55 billion. The company also disclosed that it received a subpoena about Risperdal from the U.S. Attorney's office in the Eastern District of Pennsylvania in November 2005.
That subpoena sought information about the marketing of Risperdal and adverse reactions to the drug
The company had previously received a subpoena in January 2004 from the Office of the Inspector General of the U.S. Office of Personnel Management. That subpoena sought documents concerning sales and marketing of Risperdal, as well as payments to doctors and clinical results of the drug from 1997 to 2002.
(3/20/06)- Add West Virginia to the growing list of states that are requiring the drug companies to disclose how much they spend on advertising and marketing, including gifts and other perks to doctors. California, Maine, Vermont and the District of Columbia already have such laws on their books, and Montana and New York are also contemplating the passage of such laws.
West Virginia's Pharmaceutical Cost Management Council has approved disclosure regulations, but they have not been formally written into law yet. Statistics that have been announced in Vermont for 2004, show that the drug companies spent $3.1 million in that state alone for the marketing of their drugs, according to forms filled with the attorney general for the state.
(1/06)- The newly promulgated Food and Drug Administration's rules on drug labeling will have a pronounced effect on drug advertising as well. The new label rules will apply to all new drug approvals, to drugs approved within the last 5 years, and to any drug for which a major label revision is requested. Older drugs will avoid the new rule. The new rules phase in over 7 years for drugs that have been approved in the past 5 years. The changes are voluntary for drugs that were approved more than 5 years ago.
The highly detailed pages of print ad in newspapers and magazines will be replaced by clearer statements about a drug's risks. Television ads will also have to change when they discuss a drug's risks. Drug labels will for the first time have a highlights section that summarizes the vital information needed to prescribe a drug safely.
The new section will first list safely warnings and then summarize any recent changes. There will be a new section telling doctors what they have to tell their patients about the drug. Advice as to how to use and dose the medication will be included in the label.
In a preamble to the new rules, it is stated that they pre-empt, or supersede state liability statutes.
(12/26/05)- Eli Lilly & Co. has pleaded guilty to a misdemeanor and will pay $36 million to settle criminal and civil complaints over the marketing of its Evista osteoporosis drug. The settlement was reached with the U.S. Justice Department attorney office for the Southern District of Indiana in connection with the company's off-label promotion of the drug
This is but another example of a drug company's illegal
off-label promotion of one of its drugs, for which it receives a
slap on the wrist in comparison with the amount of money it made
through increased sales of a drug for unapproved purposes.
(12/07/05)- The government has decided, after more than 2 1/2
years of investigating the charges brought by a former
Pfizer-Pharmacia employee, that it would not join the
whistle-blower suit that the employee had brought against the
company in connection with the marketing of the growth hormone
drug genotropin. Pfizer announced that it had fired the executive
who had brought the lawsuit, Dr. Peter Rost.
Dr. Rost had been a vice-president of marketing for Pharmacia in charge of marketing the drug when Pharmacia was taken over by Pfizer in April 2003. He filed a suit against Pfizer in June 2003, alleging that the company was illegally promoting the sale of the drug for unauthorized uses.
By not joining in Dr. Rost's lawsuit, the government through the Justice Department had determined that Pfizer had informed it of the allegations before Dr. Rost had instituted his lawsuit. Pfizer at the same time has filed a motion to dismiss Dr. Rost's lawsuit with the U.S. District Court in Boston, citing the prior disclosure to the government.
Pfizer terminated the employment of Dr. Rost, who had gained public attention for speaking against the company in an appearance on the television show "60 Minutes". The company stated that it had offered Dr. Rost a severance package consistent with that of employees of Pharmacia who did not remain with the company.
Dr. Rost had contended that Pharmacia offered doctors illegal inducements to use genotropin as an anti-aging drug for adults. The FDA had not approved the drug for such usage. Usually whistle-blower suits remain secret when the government participates, so the unsealing of Dr. Rost's suit is in effect a victory for Pfizer. Dr. Rost maintains that he had filed his suit before Pfizer had disclosed any information to the government.
(8/11/05)- According to figures compiled by TNS Media Intelligence, a tracker of ad spending, the pharmaceutical industry spent over $4.1 billion on direct-to-consumers ads in 2004, up from $2.5 billion in 2001. The Pharmaceutical Research and Manufacturers of America (PhRMA), the drug industry's largest trade association recently announced a set of self-policing advertising rules for its members.
Senator Charles E. Grassley (Rep.-Io.) countered with this statement: "It doesn't make sense to rely on drug companies to police themselves, … The FDA needs to stop dragging its feet and start exercising its authority to closely monitor the marketing of pharmaceuticals." The FDA has said it plans to publish a notice in the Federal Register calling for a public hearing on drug advertising. This is the first step in a long process for setting new rules in regards to pharmaceutical advertising.
(6/25/05)-The American Medical Ass'n (AMA) announced at its just concluded meeting in Chicago that it has agreed to institute a study to see whether or not direct-to-consumer ads were leading to doctors writing unnecessary prescriptions for their patients. The association's House of Delegates had considered half a dozen proposals to limit drug advertising.
The AMA is the largest organization of doctors in this country with nearly a quarter-million members. The FDA has sent out 13 warning letters to drug companies so far this year on advertising related issues. The US House of Representatives has voted to double the agency's budget for monitoring the advertising to the consumer by the pharmaceutical companies.
(6/17/05)- Bristol-Myers Squibb announced that it would impose a ban on all direct-to-consumer ads for its new drugs during their first year on the market. The company did not say what new drugs this ruling will apply to, but at least it is a small step in the right direction. The ban is part of a new advertising code that the company introduced on its Web site.
"We want to make sure that before we start mass media-television, radio and print branded advertising-that physicians have a level of comfort about the treatment and which patients are appropriate for it," said Brian Henry, a spokesman for the company.
The Pharmaceutical Research and Manufacturers of America (PhRMA), the industry's lobbying trade arm is expected to announce a new voluntary code of advertising conduct for the industry next month. It is estimated that direct-to-consumer ads accounted for about $3.8 billion in advertising costs last year.
In its new code, Bristol also called for advertising to "appropriate audiences at appropriate times of the day".
(6/3/05)- Merck & Co. is about to unveil an estimated $20 million ad campaign aimed at improving the company's public image, rather than trying to promote any one of their drugs. Executive of Merck and Oglivy & Mather-Worldwide in New York,, the agency that created the campaign, said that it had been in the works for over 2 years.
The ads will also promote the slogan for which the company wants to have stick in the minds of the consumers, namely: "Merck. Where patients come first." The TV commercials will appear on both network and cable stations. The print ads are scheduled to appear in over 40 national magazines and newspapers. The Internet ads will appear mostly in medical type Web sites such as webmed.com.
Almost half of the ad budget is aimed at promoting Merck's programs to provide some consumers with either free or reduced cost basis medications. The ads will contain the toll free number (1-800-727 5400), and the company's Web site address, (merck.com) that can be called to find out more about the programs.
Since the company had to withdraw Vioxx, its pain killing medication, in September 2004, the company has been on the defensive because of mounting criticism because of its handling of the whole process. This will be a major effort by the company to turn the negative perception that the public has about Merck and the drug industry as a whole.
(5/25/05)- The pharmaceutical industry spent $4.45 billion on advertising to consumers last year, and increase of 27% over 2003 according to TNS Media Intelligence. With Merck's painkiller Vioxx having been removed from the market and Pfizer no longer advertising to the consumer for its pain medications Bextra and Celebrexit is quite possible that there will be a drop in spending by the pharmaceutical companies for their TV ads this year. Of course there is always going to be offsets to this such as Sepracor Inc.'s spending that hopes to elevate its new sleep aid Lunesta to blockbuster status.
Pfizer Inc. is re-evaluating it ad strategy for Viagra since it learned that the prescription rate for the drug did not fall off substantially even after the FDA ordered the company to stop its main TV ads for the drug this fall. The ads had to be pulled after the FDA ruled that they did not fully explain the risks associated with taking the drug, and that the drug over-exaggerated its effectiveness. The ads for Viagra appear only on Hispanic networks right now.
The pharmaceutical industry ranked 11th in TV ad spending by industry last year.
(5/8/05)- The pharmaceutical industry spent about $3.2 billion on direct-to-consumer advertising last year. Does this extensive advertising result in over-prescription of drugs? In a study on this subject, conducted by the University of California at Davis it was found that, "The results underscore the idea that patients have substantial influence on physicians".
In the study that was conducted in 2003 and 2004 all the actresses portrayed patients suffering from symptoms of depression when they visited doctor's offices. In making 298 unannounced visits to 152 doctors the actresses followed one of three possible scripts. In the Group #1 script, the actresses said that they had seen an ad for Paxil, an antidepressant made by GlaxoSmithKline PLC, and asked for it. In the 2nd possible script the actresses said they had seen a TV program about depression and wondered whether a drug would help. In the 3rd scenario the actresses made no request whatsoever for any drug.
In Group #1 doctors prescribed antidepressants 53% of the time, with Paxil constituting 27% of the total. In Group #2 which made a general request about the possibility of being put on an antidepressant, the actresses were given one 76% of the time. In Group #3, wherein the actresses made no request for an antidepressant, they were prescribed one 31% of the time
The report said the findings "sound a cautionary note for direct-to-consumer advertising".
(4/2/05)- In an attempt to diffuse the growing number of complaints against direct-to-consumer ads, Johnson & Johnson said that it would attempt to place greater emphasis on possible negative side effects of some of its drugs. One of its first drugs to show this new philosophy will be its candid campaign for Ottho Evra birth control patch.
One of the ads shows a split-screen image with New York gynecologist Dr. Michelle Francis on one and a young woman on the other. The doctor proceeds to caution the young woman about using the patch because of the risk of blood clots, strokes and other risks. Johnson & Johnson's Chief Executive, William Welldon, who just became chairman of the drug industry's leading trade group PhRMA stated as follows, "If our industry is to retain the important right to talk directly to consumers, each or our companies in its own way must work to make DTC (direct-to-consumers) what it very definitely can be-a way to educate and counsel consumers in improving their health."
Johnson's next drug ad in the new style will be for Ditropan XL, a treatment for urinary incontinence. According to TNS Media Intelligence spending on direct-to-consumer ads rose to $4.44 billion in 2004.
(2/25/05)-According to the AARP Watchdog Report, AstraZeneca spent over $110 million advertising on television for Nexium, its next generation heartburn medication to Prilosec. Please keep in mind that Nexium is the same medication that the then Secretary of Human Services Tommy Thompson said was the same as Prilosec, the AstraZeneca heartburn medication whose patent had expired.
In connection with the determination by the safety panel that was advising the FDA about the COX-2 pain-inhibitors Vioxx, Celebrex and Bextra, the recommendation was made that restriction be placed on any direct-to-consumer ads for these products. To give you a rough idea as to how much was spent on these ads let us look at the latest figures available. Merck spent $78 million advertising Vioxx in 2003 and $72 million during the first nine months of 2004 before the drug was removed from the market according to TMS Media Intelligence. Pfizer spent $87 million on Celebrex advertisements in 2003, and$71 million during the first nine months of 2004.
The question is still open as to whether or not Merck will ask the FDA to be able to re-introduce Vioxx to the marketplace, and if it does asks for the reintrodution permission, what restrictions will be placed on the label for the drug. The next question that needs to be answered if the drug is allowed to be introduced is what type (if any), direct-to-consumer ads be allowed for the drug. It is also unknown at this time the exact extent of the restrictions that will be placed on Pfizer in trying to advertise for both Celebrex and Bextra.
(12/30/04)-The drug companies have spent over $3.8 billion in promoting their products over the last 12 months. That sum is greater than Coca-Cola, Pepsi-Cola and Cadbury spend combined each year to sell their soft drinks. In February 2002, 25% of consumers responding to the PharmTrends study said an ad had prompted them to discuss with their doctor the drug being described in the ad. Interestingly enough that number had dropped to 19% by February 2004, and has stayed at that level in the survey done 6 months later. Are the consumers beginning to question the validity of the media ads that they are seeing in connection with brand name drugs?
Pfizer, which recently agreed to suspend all advertisements for its COX-2 inhibitor pain medications Celebrex and Bextra, spent $87.6 million in advertising Celebrex in 2003. Merck which has stopped selling and advertising its COX-2 inhibitor pain medication Vioxx, spent about $78 million on advertisements for the drug this year, before the suspension took place.
AstraZeneca has spent more than $200 million in major advertising campaigns for its acid reflux medication Nexium. Nexium is the next generation drug to replace Prilosec, which went off patent protection, a couple of years ago, and can now be bought as an over-the-counter medication. Nexium is the same drug that former secretary of health and human resources Tommy Thompson should not be prescribed for by a physician because it was so similar in chemical composition to Prilosec. Because of this large advertising campaign Nexium is the 7th best selling drug in this country.
According to TNS Media Intelligence/CMR, the three major networks nightly news programs in this country received $110 million of their ad revenue from prescription medication spots. The same organization's figures show that direct-to-consumer pharmaceuticals are the 10th largest industry category in U.S. advertising in 2003.
(12/07/04)-An interesting battle is taking place in Germany between Pfizer Inc. and German health and insurance authorities concerning both the ability of a drug company to advertise its product in Europe, and also in regard to the ability of the government to regulate the price that may be charged for a drug. The drug involved in this particular case is Lipitor, the cholesterol lowering medication of Pfizer that is the largest selling drug in the world. Lipitor is sold under the name of Sortis in Germany.
Pfizer has taken out full-page ads in German newspapers to argue its case for the drug, and in so doing is flouting the law that forbids drug advertising in Europe. Pfizer announced that it intends to sue Spitzenvergaende der Krankenkassen (SdK) which is an association of health insurers in Germany. Under German law a reference price is set for a class of drugs that sets the price for a drug to be sold at. In the case of Sortis that price is 38% less than what Pfizer feels what the price of the drug should be. The company feels that its drug is better than the other statin drugs and should therefore be entitled to sell at a higher price than the others.
Pfizer also argues that the drug falls under an exception in the German drug law that protects innovative medicines. The company argues that the inclusion of the drug in the general reference price for all statins by the Gemeinsamer Bundesausschuss, the public health body that sanctioned the inclusion of Sortis in the fixed-reference scheme was incorrect.
Sortis generated EUR370 million in sales during the first nine months of the year in Germany. Drug companies face a major problem with their pricing in Europe where one country in the European Union may reimport a drug that sells for a much cheaper price in another member nation than another. In Germany, pharmacies are bound by law to purchase a minimum of 7% of their stocks through imports.
A court in Baden-Wuerttemberg forced Pfizer to amend the wording in its ads and ordered the company to pay EUR10, 000 fine for breaching the drug advertising restriction law. The German Institute for Quality and Visibility in Health Care stated that "there is no proof of Sortis' medicinal suuperiority compared to other comparable medications."
(11/25/04)-Did you ever wonder why a prescription drug ad does not mention the condition that the drug is intended to treat? There is a simple answer to this question, and the answer shows just another reason why the law, especially as it pertains to direct-to-consumer advertising, has to be revised. There are times when you are left wondering what the particular condition may be that the ad is referring to.
If an ad does not mention the condition that it is intended to treat there is no requirement for the ad to mention the adverse side effects of the drug. These ads are known as "reminder ads" were in the news lately in connection with Pfizer's ads for its erectile dysfunction drug Viagra. Pfizer has agreed to withdraw the ad in connection with Viagra that began with the comment: "Remember that guy who used to be called 'Wild Thing'? The guy wanted to spend the entire honeymoon indoors?
This ad began appearing on tv and in the media in August. The FDA's division of drug marketing, advertising and communications objected to the language in the commercials. If the ad had mentioned a specific treatment along with the brand name, the adverse side effects and other disclaimers would have had to be included in the ad.
(10/19/04)-First came Merck's Vioxx, now we have Pfizer warning doctors that its best selling next generation painkiller, Bextra, could increase the risk of heart attack or stroke in patients who have undergone coronary artery bypass surgery. Both medications are in the same class, COX-2 inhibitors. In each year from 2001 to 2003, over 50 million prescriptions were written for the COX-2 inhibitors. (Information taken from a chart appearing in the Oct 16, 2004 NY Times, page C1.)
Total sales in this class of drugs exceeded $6 billion in 2003. Now this whole class of drugs is under suspicion. In fact, the Food and Drug Administration announced that they would convene a panel of independent experts in January 2005 to review this issue and make recommendations, which are usually followed by the FDA.
Pfizer made it clear in its warning to doctors that the problems with Bextra were not the same as the one with Merck's Vioxx. The other major drug in this class is Celebrex which carries the warnings/precaution statement "risk of GI ulceration, bleeding and perforation" and suggests that a physician "monitor blood, hepatic and renal function with chronic use…[C]aution with history of peptic ulcer disease and GI bleeding, asthma, dehydration, fluid retention, HTN, heart failure… [B]orderline evaluations of liver enzymes may occur. Fluid retention and edema reported. (PDR Concise Prescribing Guide, April 2004.) Could it suffer a similar fate as Vioxx?
The company (Pfizer) has issued a denial saying more study is need on this matter..
Interestingly, Dr. Sandra Kweder, acting director of the FDA’s office of new drugs, stated that "neither Celebrex nor Bextra had been proved to be any better than older medicines like ibuprofen at guarding against stomach bleeding, a benefit often cited with these drugs, and neither have been proved to be any better at relieving pain than older drugs. (NY Times Oct. 16, 2004, page C4, "Pfizer Warns of Risks from Its Painkiller".)
Dr. Garrett FitzGerald, a University of Pennsylvania cardiologist and pharmacologist, wrote in the New England Journal of Medicine that we should not pull these drugs from the market because they are useful for certain patients. At the same time, he questions why Merck did not publish the data they had on Vioxx.
This brings us to an issue that is now first being addressed. The issue is related to what studies are being published and who has access to company-sponsored research studies. Dr. John Abramson, writing in his book "Overdo$ed America*" (p. 105) states "Often the medical researchers who carry out company-sponsored studies are not even allowed to see all of the data from studies they are working on.
These researchers are left in the position of analyzing and including in their articles only the data that drug or device manufacturers have allowed them to see…[O] ne researcher quoted in the article (NEJM May 2000) explained that controlling access to the data allows drug companies to ‘provide the spin on the data that favors them’". Now some pharmaceutical companies are planning to reveal some of their entire database on drugs in research. This means that researchers will get a chance to view all studies, both positive and negative.
The second issue relates to direct-to-consumer prescription drug advertisements of some drugs, which may not have an overall greater benefit than older drugs. According to the NY Times of Oct 13, 2004, "AstraZeneca spent $257 million on television and other mass-media advertising aimed at Nexium (the nations most widely advertised drug, approved by FDA in 2001 as a treatment for severe reflux disease) users last year. This is almost as much as spent on advertising the Acura and Saturn line of automobiles.
It has been 7 years since the FDA lifted strictures against mass-media ads and this industry has grown to a $3.8 billion-a-year business. There are those who blame these expenditures for pushing up spending on pricey drugs, which then attributes to the double digit inflation in nations healthcare costs. Others will tell you that it is the drug industry providing free samples to doctors that is a major factor in rising costs and that consumers need the information provided in mass-media advertising. In fact there is a proposal before the FDA attempting to further loosen the rules about advertising to make them more reader friendly. (It is especially hard to read the small print that accompanies these ads.)
A former commissioner of the FDA, Dr. David A. Kessler, who left the FDA before the relaxing of advertising rules, is quoted as saying that consumer-directed drug advertising "works best if the benefits of use outweigh the risks of overuse…(but too many of the ad campaigns) are about increasing use, which is about increasing sales".
A confounding factor is that the patient comes to the doctor requesting a certain prescription drug by name. The doctor does not want to alienate the patient or is pressed for time in today's health care delivery system to explore fully the alternative treatments. Advertising creates the impression that newer is better. In many cases this may be true in terms of range of side effects, but what about cost effectiveness as a factor?
This nation is going to have to deal with the safety of the newer drugs in the long run. Any new drug needs to have built into the research study a cost-benefit ratio and be tested against older medications before it is allowed to enter the mass market.
FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "HOW TO SELECT A NURSING HOME"
Allan and Harold Rubin, MS, ABD, CRC, Guest Lecturer
updated May 27, 2008
http://www.therubins.com
To e-mail: hrubin12@nyc.rr.com or rubin@brainlink.com